louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00373087: COMT Polymorphism and Entacapone Efficacy
Official title: Influence of Catechol-O-methyltransferase Polymorphism on Entacapone Efficacy in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
Catechol O-methyltransferase
Entacapone
pharmacogenetic
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2006-09-07
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Entacapone is an antiparkinsonian drug which block L-dopa metabolism, inhibiting the C-O-methyltransferase (COMT) enzyme. There is an individual variability of the COMT activity determined by a genetic polymorphism. The aim of this study is to investigate whether the genetic variability influences entacapone efficacy in Parkinson's disease.

Detailed description: COMT protein is dependent of a single autosomal locus with two co-dominant alleles with a high activity (allele H) and a low activity (allele L) form of the enzyme. L and H allele frequency in the Caucasian population is around 50%. This is a monocentric randomized blinded cross-over study comparing acute challenge of L-dopa + placebo versus L-dopa + 200 mg entacapone, in Parkinson's disease patients with HH and LL genotypes.

Eligibility criteria: Inclusion Criteria:

* Parkinson's disease
* wearing off

Exclusion Criteria:

* atypical parkinsonism
* neuroleptic use

Primary outcomes:
measure: L-dopa efficacy duration on UPDRS motor scale during an acute L-dopa test
timeFrame: during the hospitalization in 24 hours
Secondary outcomes:
measure: Pharmacokinetics of L-dopa and its metabolites
timeFrame: at the end of the study during the last hospitalization
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre d'Investigation Clinique, Hôpital de la Pitié-Salpétrière,
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jean Christophe CORVOL, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02918487: Role of Herbs in the Management of Asthma
Official title: Role of Breathe Free® in the Management of Bronchial Asthma- A Randomized Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bronchial Asthma
Lead sponsor: Composite Interceptive Med Science
Sponsor class: INDUSTRY
First posted: 2016-09-29
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The aim of this trial is to study the effect of a polyherbal capsule containing four herbs: Inula racemosa, Ocimum sanctum, Terminalia Belerica and Piperum longum in the treatment of bronchial asthma.

Detailed description: A randomized placebo controlled double blind trial. Four herbs that have proven efficacy on bronchial asthma will be given. Equally matched placebo will be given randomly to patients. Each arm active herbs and placebo will be compared against the Formoterol+Fluticasone Single maintenance and reliever therapy(SMART) and conventional therapy. All the parameters of Bronchial Asthma(BA) will be compared between the randomized groups.

Eligibility criteria: Inclusion Criteria:

* Adults aged ≥ 18 years.
* History of asthma documented by a physician for at least 6 months
* Patients on steroid therapy for at least 4 weeks.
* If not on steroid therapy, patient and physician must be willing for 4 weeks run in on steroid therapy.
* The subject agrees to participate in the study

Exclusion Criteria:

* Any one of the following

  * Acute illness (such as cold, flu, etc.) within one week before the administration of study drug
  * Abnormal hepatic and renal function
  * Pregnant, attempting to conceive, or lactating women
  * Current or former employees of organic India
  * Participating in another clinical trial with an active intervention or drug or device with last dose taken within 60 days.
  * Physician uncomfortable with patient compliance to treatments or follow up.
  * Non-compliance to tobacco cessation therapy.

Primary outcomes:
measure: Number of patients with 15% increase in forced expiratory volume(FEV1) from baseline
timeFrame: 6 months
measure: Number of patients with 50 L/min peak expiratory flow rate(PEFR) from baseline
timeFrame: 6 months
Secondary outcomes:
measure: Number of patients with frequency of asthma exacerbation per week
timeFrame: 6 months
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Mazumdar Shaw Mutispeciality Hospital
state: Karnataka
Study officials:
affiliation: Narayana Hrudayalaya Hospital
name: Dr. Alben Sigamani
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04222387: Investigation of Potential Retinal Toxicity Associated With Hair Dye Products Containing pPD Type Aromatic Amines
Official title: Investigation of Potential Retinal Toxicity Associated With Hair Dye Products Containing pPD (Para-phenylenediamine) Type Aromatic Amines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: MEK Inhibitor-Associated Serous Retinopathy
Keywords: MEK Inhibitor-Associated Serous Retinopathy
Hair dye
Aromatic amines
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2020-01-10
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Hair dye products could induce minimal forms of MEKAR retinopathies (Mitogen-activated Extracellular signal-regulated Kinase - inhibitors associated retinopathies). These minimal forms of MEKAR are likely to be underdiagnosed, since the associated visual loss is usually mild and so this condition should be considered when patients report blurred vision. The aim of the study is to analyze whether in the current population that dyes the hair, minimal forms that go unnoticed by MEKAR retinopathies can be induced.


Eligibility criteria: Inclusion Criteria:

* Hair dye up to one month before the inclusion
* Hair dye product containing aromatic amines

Exclusion Criteria:

* Pregnant or lactating woman
* Retinal pathology already known, or central serous choroiditis

Primary outcomes:
measure: % of patients with MEKAR retinopathy detected on OCT-B scan
timeFrame: Day of inclusion, up to one month month after the last hair dye
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation A de Rothschild
Study officials:
affiliation: cstimsit@for.paris
name: Claire SCEMAMA, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00838487: Evaluate Safety & Efficacy of Condroflex in Subjects With OA
Official title: Phase 3 Study, to Evaluate Safety & Efficacy of the Association Condroflex + Therapeutic Exercises Compared to Placebo + Therapeutic Exercises, in Subjects With Knee OA
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Treatment
Osteoarthritis
Elderly
Keywords: chondroitin
glucosamine
osteoarthritis
Lead sponsor: Zodiac Produtos Farmaceuticos S.A.
Sponsor class: INDUSTRY
First posted: 2009-02-06
Enrollment: 240
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary Objective: To compare, after 12 weeks of double-blind treatment, the evolution of the improvement of pain (at rest and during / after exercise) in the questionnaire WOMAC (Western Ontario and McMaster Universities Arthritis Index), achieved with Condroflex ® oral administration(sulfate glucosamine + chondroitin sulfate sodium) in association with therapeutic exercises, compared to placebo in association with therapeutic exercises in individuals with knee OA and not exposed to prior treatment with the products under investigation.

Detailed description: To have osteoarthritis degree 2 or 3 / To be capable to consent

Eligibility criteria: Inclusion Criteria:

* to have knee osteoarthritis degree 2 or 3
* to be capable to consent

Exclusion Criteria:

* previous drug treatment
* concomitant diseases
* concomitant drugs

Primary outcomes:
measure: improvement of pain
timeFrame: 12 week
Secondary outcomes:
measure: rigidity restriction
timeFrame: 12 week
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: CRDB
Study officials:
affiliation: CRM Regional Council of Medicine
name: Suely Roizenblatt
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06189287: Ethics and Research in Anaesthesia
Official title: Survey on Patients' Knowledge of Anesthesia Ethics and Research
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Ethics, Narrative
Surgery
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2024-01-03
Enrollment: 754
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - Patients over 18 years of age scheduled for surgery who agree to answer the survey

Brief summary: Under the impetus of governing bodies, learned societies, hospital management, CPPs, etc., clinical research has developed and structured considerably, in order to provide the medical community and patients with the most appropriate care, and to formulate recommendations.

In anesthesia, clinical research evaluates drugs, medical devices or care pathways. However, the general public's perception of this research in our specialty remains confidential. Several studies carried out in oncology have shown limited interest in research on the part of the general public and patients, and more often than not a lack of awareness of ethical laws and the role of french ethics committee (CPP).

By means of an anonymous questionnaire handed out at the anesthesia consultation, the investigators would like to assess patients' level of knowledge of clinical research in anesthesia, and find out how they feel about the possibility of being included in a trial.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* patient undergoing surgery

Exclusion Criteria

* Refusal to participate
* Patient unable to read or answer questionnaire

Primary outcomes:
measure: Survey response
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Nimes
country: France
facility: CHU de NIMES
Study officials:
affiliation: CHU NIMES
name: Philippe Cuvillon
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000287: Relapse Patterns in Female Cocaine Users - 4
Official title: Relapse Patterns in Female Cocaine Users
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cocaine-Related Disorders
Keywords: Cocaine-Related Disorders
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: University of Minnesota
First posted: 1999-09-21
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no

Brief summary: The purpose of this study is to pilot a relapse questionnaire and examine relapse patterns in female cocaine users.

Detailed description: The objectives of this study were to determine the most important antecedent factors in relapse episodes and difference in the use of coping skills between relapses and "close calls"

Eligibility criteria: Inclusion Criteria:

Female, cocaine abuse or dependency by SCIS, at least 7 days of current abstinence, cocaine use of 8 out of 30 days prior to current abstinence, ages 18-60.

Exclusion Criteria:

Inability to participate in a 90 day longitudinal study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Dorothy Hatsukami, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Presented at CPDD 1995 and ASAM 1997. Presented at CPDD 1995 and ASAM 1997.
Clinical trial NCT00952887: A Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACE-031 in Healthy Postmenopausal Women
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of ACE-031 (ActRIIB-IgG1) in Healthy Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Muscular Atrophy
Lead sponsor: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Sponsor class: INDUSTRY
First posted: 2009-08-06
Enrollment: 70
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to establish safe dose levels of ACE-031 in healthy postmenopausal women following multiple dose administration. This study will also evaluate if ACE-031 has an effect on muscle.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal
* Body mass index (BMI) of ≥ 18.5 to \< 32.

Exclusion Criteria:

* History of malignancy, except excised or treated basal cell carcinoma, cervical carcinoma in-situ, or ≤ 2 squamous cell carcinomas
* History of clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease.
* History of opportunistic infection (e.g. invasive candidiasis or pneumocystis pneumonia) within 6 months prior to screening or serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., septicemia) within 3 months prior to screening.
* Surgery within 3 months prior to Day 1 (other than minor cosmetic or dental procedures).
* Fever or symptomatic viral or bacterial infection within 7 days prior to Day 1.
* Donation or significant loss of blood within 2 months prior to Day 1.
* Hormone replacement therapy within 3 months prior to Day 1.
* Treatment with erythropoiesis stimulating agents (Epogen, Procrit, Aranesp, etc) within 2 months prior to Day 1.
* Systemic glucocorticoid therapy within 6 months prior to Day 1.
* Treatment with another investigational drug or approved therapy for investigational use within 1 month prior to Day 1.
* Previous treatment with ACE-031.

Primary outcomes:
measure: To evaluate the safety and tolerability of multiple, escalating doses of ACE-031 in healthy postmenopausal women
timeFrame: 6.5 months
Secondary outcomes:
measure: To estimate the pharmacokinetic (PK) and pharmacodynamic (PD) effects of multiple, escalating doses of ACE-031
timeFrame: 6.5 months
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Acceleron Investigative Site
city: Quebec City
country: Canada
facility: Acceleron Investigative Site
Study officials:
affiliation: Anapharm
name: Richard Larouche, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01951287: Impact of Fluid Milk on Post-meal Glycemia and Insulinemia in Overwt/Obese Adults
Official title: Impact of Fluid Milk on Post-meal Glycemia and Insulinemia in Overweight/Obese Adults With Normal or Impaired Glucose Tolerance or Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Glucose
Blood Insulin
Lead sponsor: Purdue University
Sponsor class: OTHER
Collaborators: name: Dairy Research Institute
First posted: 2013-09-26
Enrollment: 54
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Blood sugar and insulin levels after a meal may be altered by the food and beverages a person consumes. Keeping a healthy blood sugar level may help prevent and manage type 2 diabetes and related diseases. This study will look at how drinking different common beverages (milk, low-fat milk, nonfat milk, orange juice, coffee, and water) with a meal changes blood sugar and insulin levels.

Detailed description: The broad aim of the proposed research is to evaluate the effects of consuming milk and non-milk beverages with a breakfast meal on postprandial glucose and insulin responses in overweight and obese adults with varying levels of glucose tolerance (normal, pre-diabetic, type 2 diabetes). The investigators expect the consumption of fluid milk with breakfast to decrease the postprandial glucose response relative to other non-milk beverages (orange juice and sweetened coffee). Furthermore, the investigators expect that there will be no difference in the postprandial glucose or insulin response between varieties of fluid milk (skim, low-fat, and whole).

Eligibility criteria: Inclusion Criteria:

* 35-65 years old,
* BMI between 27-40 kg/m2,
* HbA1C less than 7.5%,
* weight stable (± 4.5 kg) for the previous 3 months
* willing to consume study foods and beverages.

Exclusion Criteria:

* using exogenous insulin,
* currently (or within the past 6 months) following a vigorous exercise regimen, or weight loss program,
* acute illness,
* smoking,
* pregnant or planning pregnancy in the next 3 months,
* lactose intolerant,
* weight changes of greater than ± 3 kg during the study period

Primary outcomes:
measure: plasma glucose levels
timeFrame: 6 mornings separated by at least a week, fasting and 30, 60, 60, 90, 120, 150,180,210,240 minutes postprandial
Secondary outcomes:
measure: Plasma Insulin Levels
timeFrame: 6 mornings separated by at least a week, fasting and 30, 60, 60, 90, 120, 150,180,210,240 minutes postprandial
Other outcomes:
Locations:
city: West lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
affiliation: Purdue University
name: Wayne Campbell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02520687: Effects of Dietary Nitrate in Hypertensive Pregnant Women
Official title: Feasibility Study on the Effects of Dietary Nitrate on Cardiovascular Function in Hypertensive Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Pregnancy
Lead sponsor: University of Manchester
Sponsor class: OTHER
First posted: 2015-08-13
Enrollment: 44
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Dietary Nitrate
Primary purpose: TREATMENT

Brief summary: High blood pressure in pregnancy affects around 10% of pregnancies, and is associated with serious adverse outcomes for both mother and baby. Treatment options for the management of high blood pressure in pregnancy are currently limited. Studies in non-pregnant individuals have shown that supplementation with dietary nitrate, using beetroot juice, can significantly lower blood pressure and improve blood flow. This study aims to investigate whether supplementation with dietary nitrate (via beetroot juice) can improve blood pressure regulation in pregnant women with chronic high blood pressure, and will also determine whether this can improve blood flow across the placenta.


Eligibility criteria: Inclusion Criteria:

* Women diagnosed with chronic hypertension (systolic blood pressure of 130-144 mmHg and/or diastolic blood pressure of 80-94 mmHg).
* Between 22 - 35+6 weeks gestation

Exclusion Criteria:

* Multi-fetal pregnancy
* Currently taking anti-hypertensive medication
* Pre-existing diabetes (Type 1 or Type 2)
* Lacking ability to consent

Primary outcomes:
measure: Change in clinic blood pressure (compared to baseline) between treatment and placebo groups
timeFrame: The outcome will be determined after 7 days treatment (compared to baseline)
Secondary outcomes:
measure: Recruitment rates
timeFrame: Across study (18 months)
measure: Uterine artery blood flow (compared to baseline)
timeFrame: The outcome will be determined after 7 days treatment (compared to baseline)
measure: Umbilical artery blood flow (compared to baseline)
timeFrame: The outcome will be determined after 7 days treatment (compared to baseline)
measure: Changes in plasma and salivary nitrate concentrations
timeFrame: The outcome will be determined after 7 days treatment (compared to baseline)
measure: Changes in plasma and salivary nitrite concentrations
timeFrame: The outcome will be determined after 7 days treatment (compared to baseline)
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Maternal and Fetal Health Research Centre
Study officials:
References:
Clinical trial NCT03504787: Upper Extremity Selective Voluntary Motor Control in Children With Unilateral Cerebral Palsy
Official title: Upper Extremity Selective Voluntary Motor Control in Children With Unilateral Cerebral Palsy and Its Association With Upper Extremity Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Keywords: cerebral palsy
upper extremity
selective motor control
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2018-04-20
Enrollment: 24
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with unilateral cerebral palsy.

Brief summary: The aim of the study was to determine upper extremity selective motor control (SMC) in Children with Unilateral Cerebral Palsy (CP). It was also aimed to determine the relationship between upper extremity SMC and upper extremity functions in unilateral CP.

Detailed description: Twenty-four unilateral CP participated in the study between the ages of 6 and 18 years. Children's manual skills classified with MACS. To assess the quality of the upper extremity, the Quality of Upper Extremity Skill Test (QUEST) which assessed four areas including dissociated movement, grasp, weight bearing and protective extension, was used. Upper extremity functions were assessed using the Jebsen Taylor Hand Function Test (JTT). The Selective Control of Upper Extremity Scale (SCUES) was used to evaluate the selective movements of the upper extremity. The SCUES evaluates the movement of the trunk during the upper limb movements and mirror movements via video recording.

Eligibility criteria: Inclusion Criteria:

* diagnosis of unilateral spastic CP,
* age between 5 and 18 years,
* ability to follow simple instructions.

Exclusion Criteria:

* significant ataxia or dystonia
* orthopedic intervention or botulinum toxin injection to the upper extremities in the last 6 months
* orthopedic problems or medical conditions that prevented children from participating in the assessment

Primary outcomes:
measure: Selective Control of the Upper Extremity Scale (SCUES)
timeFrame: 10 minutes
Secondary outcomes:
measure: Jebsen Taylor Hand Function Test (JTT)
timeFrame: 10 minutes
measure: Quality of Upper Extremity Skill Test (QUEST)
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazı University
Study officials:
affiliation: Gazi University
name: Bulent Elbasan
role: STUDY_CHAIR
References: