What can we Believe? Some Observations on the Design of Clinical Investigations

2015 ◽  
pp. 72-92
Author(s):  
I. D. Rotkin
Keyword(s):  
Clinical Investigations

Clinical Investigations of Drug Effects in Women

1986 ◽  
Author(s):  
Jack H. Mendelson ◽  
◽  
Nancy K. Mello
Keyword(s):  
Drug Effects ◽  
Clinical Investigations

Basic Problems of Logic in Drug Investigations

1974 ◽  
Vol 13 (04) ◽  
pp. 248-253
Author(s):  
H. Röpke
Keyword(s):  
Animal Experiments ◽  
Point Of View ◽  
Applied Logic ◽  
Clinical Investigations

The basic problems of the theory of cognition when extrapolating the results of animal experiments to man and the limitations of inferences from clinical investigations of drugs are discussed from the point of view of applied logic.

EVALUATION OF HYSTEROSALPINGOGRAPHY VERSUS LAPAROSCOPY IN THE DETERMINATION OF TUBAL FACTORS IN FEMALE INFERTILITY: A HOSPITAL BASED COMPARATIVE STUDY.

2020 ◽  
Vol 4 (9) ◽  
Author(s):  
Richa Choudhary ◽  
Rishikant Sinha
Keyword(s):  
Female Infertility ◽  
Diagnostic Methods ◽  
Panoramic View ◽  
Tubal Patency ◽  
Pelvic Organs ◽  
Clinical Investigations ◽  
Detailed Assessment ◽  
Reproductive Anatomy ◽  
Tubal Pathology

Objectives: Hysterosalpingography and laparoscopy both are the diagnostic methods for assessment of female infertility.  The present study was to compare the evaluation of hysterosalpingography (HSG) versus laparoscopy in determination of tubal factors in female infertility. Methods: Detailed assessment, physical examination and clinical investigations were performed in all 100 infertile female with age 20 years to 40 years. All patients were advised to perform digital HSG. Patients with an abnormal HSG underwent laparoscopy without delay, whereas in patients with a normal HSG, laparoscopy was performed three months after HSG. HSG is best scheduled during the 2nd -5th day interval immediately following the end of menstruation, to minimize risk for infection, avoid interference from intrauterine blood and clot, and to prevent any possibility that the procedure might be performed after conception. Results: Data was analysed by using IBM SPSS version 23 software.  All data was tabulated and percentages were calculated. Mean ± standard deviation was observed. Conclusions: Diagnostic laparoscopy is the gold standard in diagnosing tubal pathology and other intra-abdominal causes of infertility. Other hand, Hysterosalpingography is a frequently utilized diagnostic tool in the assessment of tubal status and detection of uterine anatomical defects in infertility. Hysterosalpingography and laparoscopy are not alternatives but complimentary investigations. But, inadequacy of hysterosalpingography (HSG) in determining the state of tubal patency, emphasizes the need for laparoscopy. Laparoscopy provides both a panoramic view of the pelvic reproductive anatomy and a magnified view of pelvic organs and peritoneal surfaces. Keywords: Female infertility, Tubal patency, HSG, Laparoscopy

CLINICAL INVESTIGATIONS OF A LONG-ACTING OESTRIOL (POLYOESTRIOL PHOSPHATE)

1961 ◽  
Vol 38 (1) ◽  
pp. 73-87 ◽  
Author(s):  
Christian Lauritzen ◽  
Semih Velibese
Keyword(s):  
Side Effects ◽  
Phosphoric Acid ◽  
Quantitative Data ◽  
Water Soluble ◽  
Cholesterol Concentration ◽  
Experimental Investigations ◽  
Clinical Investigations ◽  
Prolonged Duration ◽  
High Doses ◽  
Long Acting

ABSTRACT A description is given of experimental investigations and preliminary clinical experience with the long-acting oestriol compound polyoestriol phosphate – a water-soluble polymere of oestriol and phosphoric acid. The compound seems to exert all the physiologically important effects of oestriol. Even with high doses the hormone causes no proliferation of the endometrium and no withdrawal bleeding. It has no untoward effect on metabolism. It decreases slightly the cholesterol concentration (to the extent of ⅓–⅕ of the effect produced by long-acting oestradiol esters). The compound has a wide therapeutic range. No side-effects have been observed. Doses of 10 mg or more have a prolonged duration. Additional prolongation of the effect is largely dependent on dosage. To ensure an effect lasting for 4 weeks 40 mg polyoestriol phosphate (corresponding with 30 mg oestriol) is required – an amount which roughly corresponds with physiological quantitative data. The compound, which involves an interesting new principle of prolongation, was most effectively used in the treatment of menopausal symptoms and genital organic disorders. For these indications it can be recommended without reservation.

Specialized Food Product with Directed Systemic Action: Innovative Technological Solutions, Performance Evaluation

Food Industry ◽  
2020 ◽  
Vol 5 (1) ◽  
pp. 58-64
Author(s):  
Andrey Vekovtsev ◽  
Tokhiriyon Boisjoni ◽  
Badarch Bayambaa ◽  
Victor Shelepov
Keyword(s):  
Musculoskeletal System ◽  
Food Product ◽  
Biologically Active ◽  
Innovative Technology ◽  
Manganese Sulfate ◽  
Mineral Complex ◽  
Technological Production ◽  
Clinical Investigations ◽  
Active Additive ◽  
Macro Nutrients

The authors developed composition and innovative technology of a new specialized product in the form of a biologically active additive to normalize metabolic processes in the case of the musculoskeletal system damage. They obtained specialized product through innovative tableting technology providing high consumer properties, components preservation and its active principles. The technological solutions innovativeness enables to separate composition ingredients considering its chemical and pharmacological incompatibility, and to deliver it sequentially to various sections of the gastrointestinal tract at a given speed. Glucosamine sulfate as a part of the vitamin and mineral complex combining with minerals (micro- and macro-nutrients) – manganese sulfate, calcium hydroxyapatate, cholecoleceferol, zinc and magnesium oxides – have unidirectional functional properties related to the metabolism correction in case of the musculoskeletal system damage. Clinical investigations confirmed the vitamin and mineral complex effectiveness. The diet for children 8- 14 years old has included one capsule of the specialized product additionally three times a day. Children (3-7 years old) with the long tubular bones fracture have received one capsule twice a day. Authors tested the recipe and technological production parameters at the enterprises of the company “Artlife” under the conditions of international and domestic standards including GMP and guaranteeing the quality indicators and competitiveness stability.

Excitotoxicity as a Target Against Neurodegenerative Processes

2020 ◽  
Vol 26 (12) ◽  
pp. 1251-1262 ◽  
Author(s):  
Octavio Binvignat ◽  
Jordi Olloquequi
Keyword(s):  
Neurodegenerative Diseases ◽  
Effective Treatment ◽  
Molecular Mechanisms ◽  
Prolonged Exposure ◽  
Mitochondrial Dysfunctions ◽  
Beneficial Effects ◽  
Clinical Investigations ◽  
Turn Over ◽  
Excitotoxic Cell Death ◽  
Lateral Sclerosis

: The global burden of neurodegenerative diseases is alarmingly increasing in parallel to the aging of population. Although the molecular mechanisms leading to neurodegeneration are not completely understood, excitotoxicity, defined as the injury and death of neurons due to excessive or prolonged exposure to excitatory amino acids, has been shown to play a pivotal role. The increased release and/or decreased uptake of glutamate results in dysregulation of neuronal calcium homeostasis, leading to oxidative stress, mitochondrial dysfunctions, disturbances in protein turn-over and neuroinflammation. : Despite the anti-excitotoxic drug memantine has shown modest beneficial effects in some patients with dementia, to date, there is no effective treatment capable of halting or curing neurodegenerative diseases such as Alzheimer’s disease, Parkinson disease, Huntington’s disease or amyotrophic lateral sclerosis. This has led to a growing body of research focusing on understanding the mechanisms associated with the excitotoxic insult and on uncovering potential therapeutic strategies targeting these mechanisms. : In the present review, we examine the molecular mechanisms related to excitotoxic cell death. Moreover, we provide a comprehensive and updated state of the art of preclinical and clinical investigations targeting excitotoxic- related mechanisms in order to provide an effective treatment against neurodegeneration.

Investigation of ACE rs4646994, MTHFR rs1801133 and VDR rs2228570 Genotypes in Jordanian Patients with Fibromyalgia Syndrome

2020 ◽  
Vol 21 ◽  
Author(s):  
Raida Khalil ◽  
Wajdy J. Al-Awaida ◽  
Hamzeh J. Al-Ameer ◽  
Yazun Jarrar ◽  
Amer Imraish ◽  
...  
Keyword(s):  
Sleep Disturbances ◽  
Fibromyalgia Syndrome ◽  
Methylenetetrahydrofolate Reductase ◽  
Pain Tolerance ◽  
The Body ◽  
Restless Leg Syndrome ◽  
Jordanian Arabic ◽  
Clinical Investigations ◽  
Polymerase Chain ◽  
Larger Sample

Background: Fibromyalgia syndrome (FMS) is a chronic disease characterized by widespread body pain, weakness in certain parts of the body (critical points), low pain tolerance, sleep disturbances, and fatigue. This syndrome is considered rare in Jordan. Objectives: The research aimed to find out the association of the angiotensin converting enzyme, methylenetetrahydrofolate reductase, and vitamin D receptor (ACE, MHFTR, and VDR, respectively) genotypes with FMS among Jordanian patients. Methods: This work included 22 FM patients and 22 healthy individuals of Jordanian Arabic origin. The ACE rs4646994, MTHFR rs1801133, and VDR rs2228570 genotypes were determined using polymerase chain reaction (PCR) followed by restriction fragment length polymorphism. Results: No associations between ACE rs4646994, MTHFR rs1801133, and VDR rs2228570 with the vulnerability of a person for the development of FMS were found. However, we found an association between the ACE rs4646994 genotype and restless leg among FM patients. Conclusion: Based on result from this study, it appears that the ACE rs4646994 genotype is associated with restless leg among FMS patients of Jordanian origin. Further clinical investigations with larger sample sizes are required to confirm these findings and to understand the molecular mechanism of ACE rs4646994 genetic variant in the restless leg syndrome among FM patients.

scholarly journals Repurposing existing drugs for new uses: a cohort study of the frequency of FDA-granted new indication exclusivities since 1997

2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Babak Sahragardjoonegani ◽  
Reed F. Beall ◽  
Aaron S. Kesselheim ◽  
Aidan Hollis
Keyword(s):  
Therapeutic Potential ◽  
Drug Repurposing ◽  
Status Quo ◽  
New Drugs ◽  
Generic Entry ◽  
Small Molecule Drugs ◽  
Clinical Investigations ◽  
Fda Approval ◽  
Limited Duration ◽  
Observation Period

Abstract Background Drug repurposing (i.e., finding novel uses for existing drugs) is essential for maximizing medicines’ therapeutic utility, but obtaining regulatory approval for new indications is costly. Policymakers have therefore created temporary indication-specific market exclusivities to incentivize drug innovators to run new clinical investigations. The effectiveness of these exclusivities is poorly understood. Objective To determine whether generic entry impacts the probability of new indication additions. Methods For a cohort of all new small-molecule drugs approved by the FDA between July 1997 and May 2020, we tracked new indications added for the subset of drugs that experienced generic entry during the observation period and then analyzed how the probability of a new indication changed with the number of years since/to generic entry. Results Of the 197 new drugs that subsequently experienced generic entry, only 64 (32%) had at least one new indication added. The probability of a new indication addition peaked above 4% between 7 and 8 years prior to generic entry and then to dropped to near zero 15 years after FDA approval. We show that the limited duration of exclusivity reduces the number of secondary indications significantly. Conclusion Status quo for most drug innovators is creating novel one-indication products. Despite indication-specific exclusivities, the imminence of generic entry still has a detectable impact on reducing the chances of new indication additions. There is much room for improvement when it comes to incentivizing clinical investigations for new uses and unlocking existing medicines’ full therapeutic potential.

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