louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00947076: To Demonstrate the Relative Bioavailability of Fluoxetine Hydrochloride Capsules, 40 mg
Official title: A Comparative Bioavailability Study of Fluoxetine Hydrochloride Capsules, 40 mg
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depression
Keywords: Antidepressant
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-07-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To demonstrate the relative bioavailability of fluoxetine hydrochloride capsules, 40 mg.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.

Primary outcomes:
measure: Bioequivalence based on AUC and Cmax
timeFrame: 42 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: PharmaKinetics Laboratories Inc.
name: Ronald Goldwater, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03084276: Effect of Meal Composition on the Responses to Meal Ingestion
Official title: Factors That Determine the Responses to Meal Ingestion: Meal Composition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: meal ingestion
meal composition
postprandial responses
hedonic sensations
homeostatic sensations
new composition
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2017-03-20
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Aim: to determine to what extent meal composition influences postprandial sensations independently of palatability. The postprandial responses to a low-fat (240 Kcal) versus a high-fat (275 Kcal) test meal (150 g humus) with the same physical and organoleptic characteristics (taste, smell, colour, texture, consistency, temperature) will be studied on a cross-over design. The responses to the meals will be tested on 2 different days. Participants (12 non-obese healthy men) will be instructed to eat a standard dinner the day before, to consume a standard breakfast at home after overnight fast, and to report to the laboratory, where the test meal will be administered 3 h after breakfast. Studies will be conducted in a quiet, isolated room with participants sitting on a chair. Perception will be measured at 5 min intervals 10 min before and 20 min after ingestion and at 10 min intervals up to 60 min after the probe meal.


Eligibility criteria: Inclusion Criteria:

* non-obese

Exclusion Criteria:

* history of gastrointestinal symptoms
* prior obesity
* use of medications
* history of anosmia and ageusia
* current dieting
* alcohol abuse
* psychological disorders
* eating disorders

Primary outcomes:
measure: Change in digestive well-being measured after the test meal
timeFrame: 1 day
Secondary outcomes:
measure: Change in satiety measured after the test meal
timeFrame: 1 day
measure: Change in fullness sensation measured after the test meal
timeFrame: 1 day
measure: Change in abdominal discomfort/pain sensation measured after the test meal
timeFrame: 1 day
measure: Change in mood measured after the test meal
timeFrame: 1 day
Other outcomes:
measure: Meal palatability
timeFrame: 1 day
Locations:
city: Barcelona
country: Spain
facility: University Hospital Vall d'Hebron
Study officials:
References:
Clinical trial NCT01521676: Predictive Clinical and Biological Parameters in Breast Cancer
Official title: Research of Predictive Clinical and Biological Parameters in Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2012-01-31
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Research of predictive clinical and biological factors in breast cancer :

genomic, proteomic, mutation


Eligibility criteria: Inclusion Criteria:

* breast cancer
* age \> 18
* signed informed consent

Exclusion Criteria:

* emergency

Primary outcomes:
measure: molecular alteration in breast cancer
timeFrame: average of 4 weeks after diagnosis
Secondary outcomes:
measure: relation between molecular alteration and clinical and histological characteristics
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Toulon
country: France
facility: Hôpital Sainte-Musse
Study officials:
affiliation: Institut Paoli-Calmettes
name: Carole TARPIN, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Goncalves A, Bertucci F, Guille A, Garnier S, Adelaide J, Carbuccia N, Cabaud O, Finetti P, Brunelle S, Piana G, Tomassin-Piana J, Paciencia M, Lambaudie E, Popovici C, Sabatier R, Tarpin C, Provansal M, Extra JM, Eisinger F, Sobol H, Viens P, Lopez M, Ginestier C, Charafe-Jauffret E, Chaffanet M, Birnbaum D. Targeted NGS, array-CGH, and patient-derived tumor xenografts for precision medicine in advanced breast cancer: a single-center prospective study. Oncotarget. 2016 Nov 29;7(48):79428-79441. doi: 10.18632/oncotarget.12714.
Clinical trial NCT02150876: SWiss Evaluation of Bioabsorbable Polymer-coated Everolimus-eluting Coronary sTent
Official title: SWiss Evaluation of Bioabsorbable Polymer-coated Everolimus-eluting Coronary sTent The SWEET Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: DES
SDF
MACE
SYNERGY
Lead sponsor: University of Freiburg
Sponsor class: OTHER
First posted: 2014-05-30
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients treated with SYNERGY stents at Bern and Fribourg university hospitals and La Tour Hospital in Geneva until June 30, 2014 will be retrospectively included in the study.

Brief summary: Bioresorbable polymer drug eluting stents (DES) are an indisputable improvement over first-generation DES with promising results on long-term adverse events. But the thicker polymer and/or strut may hinder its deliverability. Complex procedures challenge stent deliverability and stent delivery failure impacts clinical prognosis.

This registry aimed to assess the immediate performance of the third-generation Synergy everolimus-eluting stent (sEES) and its 12-month clinical follow-up in an all-comer population.

Detailed description: All consecutive patients treated with the SYNERGY stent at our institutions were prospectively included in the SWEET registry. Baseline and procedural characteristics were collected at index procedure. Clinical follow-up was performed at 1 month and 1 year by clinic visit or follow-up call. The study end point was a composite of cardiac death (CD), myocardial infarction (MI) and target lesion revascularization (TLR) at 1 year.

Eligibility criteria: Inclusion Criteria:

1.Patient treated by everolimus-eluting SYNERGY® stent

Exclusion Criteria:

1. Patient or legal guardian won't give consent to use collected data

Primary outcomes:
measure: MACE
timeFrame: at 12 month follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Freiburg
country: Switzerland
facility: University of Freiburg
Study officials:
affiliation: University of Freiburg
name: Stéphane P Cook, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05286476: Effect of 6 Weeks of Whole-body Vibration in Treatment of Postnatal Constipation
Official title: Effect of 6 Weeks of Whole-body Vibration in Treatment of Postnatal Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation
Keywords: Whole Body Vibration
Postnatal women
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-03-18
Enrollment: 40
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Postpartum constipation is a common problem affecting postpartum mothers. Aim: To determine whether Whole Body Vibration is effective in treatment of postnatal women constipation. Design: The study was designed as a prospective, randomized, single-blind, pre-post-test, controlled trial.

HYPOTHESES:

It will be hypothesized that:

It was hypothesized that whole-body vibration has no or limited effect in treatment of postnatal constipation RESEARCH QUESTION: Does whole-body vibration has an effect in treatment of postnatal constipation?

Detailed description: Methods: Group A received whole-body vibration, pelvic floor exercise and static abdominal exercises interventions for six weeks and group B received pelvic floor exercises and static abdominal exercises in addition to diet instructions in both groups. Constipation symptom questionnaire and patient assessment of constipation quality of life questionnaire is applied before and after treatment.

Eligibility criteria: Inclusion Criteria:

* The participants age ranged from 22 to 35 years old
* with vaginal delivery
* complain from postnatal constipation from (2 - 6 weeks) post-delivery
* had body mass index (BMI) ranged from 30 to 32 kg/m2.

Exclusion Criteria:

Participants were excluded if they:

* had diabetes, hypertension, cardiac diseases.
* Women who had history of inflammatory bowel disease and abnormalities of anal region or anal fissure
* women who had history of bowel surgery (other than appendectomy),
* patients who had endocrine disease or digestive tract disease
* history of neurological or musculoskeletal disorder.

Primary outcomes:
measure: Patient Assessment of Constipation-Symptom questionnaire
timeFrame: Change from Baseline then after 6 weeks of intervention.
measure: Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL)
timeFrame: Change from Baseline then after 6 weeks of intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy
Study officials:
affiliation: Cairo University
name: Doaa raafat, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01214876: Correlating Protection Against Malaria With Serum Profiles Against Plasmodium Falciparum Antigen Repertoires
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malaria
Schistosomiasis
Hiv Infection
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: London School of Hygiene and Tropical Medicine
name: Medical Biotech Laboratories
name: University Of Perugia
name: Imperial College London
name: Microtest Matrices Ltd
First posted: 2010-10-05
Enrollment: 500
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Randomly selected individuals living in Abedi, Apac District, Uganda.

Brief summary: A longitudinal study on immune responses in relation to protection against clinical malaria episodes will be conducted in Apac District, Uganda. Three cohorts will be recruited: children 1 to 5 years of age (n=250), children 6 to 10 years of age (n=125) and adults 25 and above (n=125). After finger prick sampling (\~300µL) and examination at enrolment, participants will be followed up for one year. Follow-up will include fortnightly active case detection and three-monthly cross-sectional surveys. Clinical malaria attacks and the associated clinical and parasitological parameters will be related to immunological profiles determined utilizing a protein microarray as a capture substratum to profile the humoral immune response against a vast number of parasite antigens.

For individuals who experience a clinical malaria attack or who are diagnosed with high density parasitaemia (≥15,000 parasites/µL) during cross-sectional surveys, a 5mL blood sample is obtained to determine the diversity of parasite antigens in the population in relation to antigen recognition in the cohort.


Eligibility criteria: Inclusion Criteria:

* age 1-5 years, 6-10 years or 25 yearsand above
* written informed consent must be given
* the individual must have been resident of the area since birth or for a minimum period of two years
* the individual must be willing to submit required information and to participate in repeated sampling (total blood volume \~2.5 mL over a period of 12 months)
* Absence of danger signs (as defined by WHO) or clinical features of AIDS. An HIV-test will be offered to all participants at enrolment and completion of the study.

Exclusion Criteria:

* unwillingness to sign consent form
* unwillingness to reside in the study area during the follow-up period

Primary outcomes:
measure: Immune correlates of protection against clinical malaria episodes with plasmodium falciparum
Secondary outcomes:
measure: Geographical patterns in malaria morbidity
measure: Asymptomatic parasite carriage and immune responses in different age-groups exposed to intense malaria transmission
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Medical Biotech Laboratories
Study officials:
References:
Clinical trial NCT02458976: Pulsed-dye Laser Treatment Prior to Surgical Excision
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cicatrix
Keywords: Scar
Pulsed-dye laser
PDL
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2015-06-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This prospective pilot study will investigate whether use of a pulsed dye laser (PDL) prior to surgical excision can improve the appearance and symptoms of scars. The primary outcome measurement for the study is the quality of the scar in areas pre-treated with PDL vs. control (cryogen spray only). For this study, subjects who are scheduled for a dermatologic surgical excision will have half of the surgical area pre-treated with PDL and the other half pre-treated with cryogen spray.


Eligibility criteria: Inclusion Criteria:

* Subjects with ages between 18 and 65 years, who are scheduled for a dermatologic surgical excision
* Subjects requiring surgical excisions for any condition
* Subjects with any Fitzpatrick skin type
* Willingness to participate in the study
* Willingness to receive experimental treatment
* Informed consent agreement signed by the subject
* Willingness to follow the follow-up schedule
* Willingness to not use any other scar treatments during the study period (i.e scar massage, over-the-counter silicone pads, intralesional steroid of 5-fluorouracil injections, laser treatments)

Exclusion Criteria:

* Pregnancy
* Prior scar in area to be treated
* Known photoallergy to visible light (i.e polymorphous light eruption)
* Subject is unable to comply with treatment or follow-up visits
* Subject with a history of being on photosensitive medications for the past 3 months (thiazides \[used to treat high blood pressure\], tetracyclines, fluoroquinolones griseofulvin or sulfonamides \[used to treat infections\], sulfonylureas \[used to treat diabetes\], calcium channel blockers \[used to treat hypertension\], phenothiazines \[used to treat serious emotional problems\]).
* Known autoimmune disease (some autoimmune diseases can lead to sensitivity to light, such as lupus erythematosus)
* Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device

Primary outcomes:
measure: Scar appearance
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: MGH
name: R R Anderson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00889876: Effect of Exercise or Metformin on Nocturnal Blood Pressure and Other Risk Factors for CVD Among Obese Adolescents
Official title: Effect of Exercise or Metformin on Nocturnal Blood Pressure and Other Risk Factors for Cardiovascular Disease (CVD) Among Obese Adolescents
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Obesity
Adolescents
Nocturnal blood pressure reduction
Insulin metabolism
Cardiovascular structure and function
Treatment
Exercise
Metformin
Insulin
Blood glucose
Impaired nocturnal blood pressure reduction
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2009-04-29
Enrollment: 26
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The objective is to, among obese adolescents, study impact of regular physical activity or metformin therapy on nocturnal blood pressure and related cardiovascular disease risk factors.

Detailed description: Forty subjects will be assigned to the exercise intervention group, thirty to the metformin therapy group and thirty to the control group. Group I will be treated daily with metformin. Group II will perform exercise (endurance) three times/week with a personal coach and group III will serve as control. All participants will be examined at baseline, after 3 months of intervention, after 6 months of intervention and after one year of intervention. Examination includes anthropometric measures, measures of ambulatory 24-h blood pressure and insulin sensitivity, measures for function and structure of the heart and vessels, analysis of atherogenic factors in the blood, aerobic fitness testing and measurement of daily physical activity.

Eligibility criteria: Inclusion Criteria:

* Age 13-19 years old at inclusion date
* Obesity according to gender and age specific BMI (Cole 2000)
* Reduced nocturnal systolic blood pressure fall (\< 10%)
* Signed informed consent by patient and parents

Exclusion Criteria:

* Cardiovascular disease
* Insulin dependent diabetes mellitus
* Patient on medications that are contraindicated during Metformin treatment
* Pregnancy
* Mental or physical conditions limiting the ability to participate

Primary outcomes:
measure: Normalization of nocturnal blood pressure dipping
timeFrame: Before and 3, 6 and 12 months of intervention
Secondary outcomes:
measure: Normalization of insulin metabolism and cardiovascular structure and function
timeFrame: Before and 3, 6 and 12 months of intervention
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet, Karolinska University Hospital Huddinge
Study officials:
affiliation: Karolinska Institutet
name: Claude Marcus, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00172276: Angiotensin Converting Enzyme Gene Polymorphism in Children With Idiopathic Nephrotic Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nephrotic Syndrome
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Observational model: CASE_CONTROL
Time perspective: OTHER

Brief summary: Aims This study was conducted to examine the association between the ACE insertion/deletion (I/D) genotype distribution in children with idiopathic nephrotic syndrome and the response to steroid therapy.

Patients and Methods The patients with idiopathic nephrotic syndrome were divided into 2 groups according to their clinical response to steroid: SS group including infrequent and frequent relapsers and non-SS group including steroid resistant (SR) and steroid dependent (SD) patients. Children without previous renal diseases and negative proteinuria were enrolled as control group in genetic study. The genotypes for ACE gene I/D polymorphism including DD, ID and II were analyzed by the newly developed automatic denaturing high performance liquid chromatography system (DHPLC).


Eligibility criteria: Inclusion Criteria:

* Total 59 children diagnosed as nephrotic syndrome at the age of 1 to 10 year-old were recruited in this study. These children with nephrotic syndrome were under follow-up at the Pediatric Nephrology Clinic in National Taiwan University Hospital. In addition, children without previous renal diseases and negative proteinuria were enrolled as control group in genetic study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Taiwan University Hospital
name: Yong-Kwei Tsau, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02621827: Vitamin D Half-life in Pregnancy and Lactation
Official title: Vitamin D Half-life in Pregnancy and Lactation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Lactation
Keywords: vitamin D
Africa
Lead sponsor: Medical Research Council
Sponsor class: OTHER_GOV
First posted: 2015-12-04
Enrollment: 49
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study measures the plasma half-life of 25-hydroxyvitamin D3 (25(OH)D3) in non-pregnant-non-lactating women, pregnant women at 30 wk gestational age and at 3 months post-partum in women who are exclusively breast-feeding.


Eligibility criteria: Inclusion Criteria:

All participants:

* Currently resident in West Kiang and planning to stay for the next 5 months
* Aged between 18 and 45 y

Pregnancy:

* \> 20 wk \< 30 wk pregnant (gestational age assessment by ultrasound)
* Singleton fetus

Lactation:

* Breast feeding

Exclusion Criteria:

All participants:

* Severe anaemia (haemoglobin \< 7 g/dL) (as per ENID protocol)
* Known sickle cell anaemia
* Known to be asthmatic or allergic to peanuts (already excluded from ENID)
* Known history of liver, kidney, gut or malabsorption problems
* Other chronic condition
* On prescription medication
* Taking vitamin D supplements (\> 200 IU/d)
* Broken bone in last 3 y
* Recent infection or illness (2 weeks prior to the start of a study period)
* Reported onset of menopause (already excluded from ENID)
* Malaria parasitemia (prior to study period)
* Unable to consent

Pregnant:

* Pregnancy-related complications or on discretion of mid-wife
* Known HIV positive

Lactation:

* Health problem of mother or infant that may affect feeding practices

Primary outcomes:
measure: Plasma concentration of stable isotope labeled 25(OH)D3
timeFrame: Samples collected on day 6, 9, 21, 24, 27 and 30 post-dose
Secondary outcomes:
measure: Plasma concentration of vitamin D metabolites and related calciotropic hormones
timeFrame: Fasting plasma samples collected at baseline and 21 days post-dose
measure: Urinary concentration of calcium, phosphate, creatinine and cyclic adenosine monophosphate (cAMP)
timeFrame: Samples collected at baseline and 21 days post-dose
measure: Weighed dietary intake
timeFrame: 2 days within 30 days of dose
Other outcomes:
Locations:
Study officials:
References: