louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00005512: Genetic Epidemiology--Development of Cardiovascular Risk
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Hypertension
Obesity
Heart Diseases
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2000-05-26
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no

Brief summary: To determine how genetic and environmental factors influence the co-occurrence of obesity and hypertension during development and to identify cardiovascular risk factors in adolescence that will predict cardiovascular disease in adults.

Detailed description: BACKGROUND:

Obesity and hypertension are two of the major risk factors for cardiovascular disease (CVD) and those with obesity have a greater risk of hypertension. In children and adolescents, high body mass index correlates with elevated blood pressure. Genetic factors make a significant contribution to the variation of obesity and hypertension.

DESIGN NARRATIVE:

Anthropometric, cardiovascular, physiologic and physical fitness data were used to investigate a series of critical issues about the etiology, heterogeneity, comorbidity and developmental trajectories of CVD risk factors, including obesity, hypertension and cardiovascular health. Using the two datasets, the main questions of the study were addressed. How do genes and environment act and interact to create covariation between obesity and hypertension, and were the genetic and environmental factors the same at all ages (from childhood to late adolescence and adulthood) in both sexes? Areas of research included the following: causes of individual differences in anthropometric and cardiovascular characteristics, their covariation and developmental change or continuity in adolescence, parent-offspring transmission, prediction of cardiovascular risk, and sex, race and population differences in genetic and environmental contributions on cardiovascular risk factors.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Virginia Commonwealth University
name: Hermine Maes
References:
citation: Beunen G, Thomis M, Maes HH, Loos R, Malina RM, Claessens AL, Vlietinck R. Genetic variance of adolescent growth in stature. Ann Hum Biol. 2000 Mar-Apr;27(2):173-86. doi: 10.1080/030144600282280.
citation: Sicherer SH, Furlong TJ, Maes HH, Desnick RJ, Sampson HA, Gelb BD. Genetics of peanut allergy: a twin study. J Allergy Clin Immunol. 2000 Jul;106(1 Pt 1):53-6. doi: 10.1067/mai.2000.108105.
Clinical trial NCT02704312: Dosimetric Comparison of Doses in Both Positions (Prone and Decubitus) for Patient With Breast Cancer
Official title: A Feasibility Study of Patient Comfort and Dosimetry Evaluation in Prone Breast Radiotherapy.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: University Hospital Center of Martinique
Sponsor class: OTHER
First posted: 2016-03-10
Enrollment: 11
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Compare dosimeters in both positions (prone and decubitus) for each patient

Detailed description: Quantitative Physics: dosimetric comparison of doses in target volumes and organs at risk. The technique used is that of which the dose on the organs at risk is as low as possible, and whose dose to the target volume is the closest possible to the prescribed dose (100% of the prescribed dose).

Eligibility criteria: Inclusion Criteria:

* Patients with primary breast cancer and in whom conservative post- surgery radiation therapy for breast cancer is prescribed.
* Patients aged over 18 years
* Patients with indication for conservative surgery.
* Resection should be in healthy margin.
* Women of childbearing potential must satisfy a negative pregnancy test at the screening visit and use effective contraception as determined by the physician of the patient throughout the study.

Exclusion Criteria:

* Minor Patient
* Patients whose tumor resection is incomplete
* Patients with an indication of mastectomy
* Patients with a history of radiation therapy of the chest
* Pregnant women, lactating, or of childbearing age without effective contraception.
* Patients who had more than 4 scanners in one year. ( Scanner cervical , thoracic, or abdominal
* Patients with an incompatible condition with monitoring protocol (psychiatric disorder, uncontrolled disease).
* Patient unable to respond to a questionnaire

Primary outcomes:
measure: Quantitative Physics: dosimetric comparison of doses in target volumes and organs at risk
timeFrame: From baseline to 5 weeks
Secondary outcomes:
measure: Quality of Life Questionnaire
timeFrame: Baseline and Follow up month 3, 12, 24 and 36
Other outcomes:
Locations:
city: Fort de France
country: Martinique
facility: CHU de Martinique
Study officials:
affiliation: CHU de Martinique
name: Vincent VINH HUNG, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01430312: 21 Day Irritancy Test of Azelaic Acid Pre-foam Formulation
Official title: A Randomized, Double-blind, Vehicle-controlled Phase 1 Dermal Safety Study Using a 21 Day Cumulative Irritant Patch Test Design to Evaluate the Local Tolerability of Azelaic Acid Pre-Foam Formulation in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: dermal irritative potential
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
Collaborators: name: Bayer
First posted: 2011-09-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine the irritancy potential of azelaic acid pre-foam formulation.

Detailed description: This is the standard patch test over 21 days of exposure of the test product,its vehicle and a positive as well as a negative control.

Eligibility criteria: Inclusion Criteria:

* healthy volunteers
* male ore female subjects
* aged 18 - 65 years
* ability to understand and fulfill the study requirements

Exclusion Criteria:

* affected skin in designated test area
* pregnancy or lactation
* not willing to comply with study requirements

Primary outcomes:
measure: irritancy rating scale
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Fargo
country: United States
facility: Robert I. Cooper, MD
state: North Dakota
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06379412: A Cross-sectional Study on the Association of Peptidoglycan Fragments Derived From Gut Microbiota With Colorectal Cancer
Official title: A Cross-sectional Study on the Association of Peptidoglycan Fragments Derived From Gut Microbiota With Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2024-04-23
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Meet eligibility criteria

Brief summary: The goal of this observational study is to explore the association of peptidoglycan fragments derived from gut microbiota with colorectal cancer (CRC). The main question it aims to answer is: Are peptidoglycan fragments from the gut microbiota associated with the progression of colorectal cancer? Participants will provide biological specimens (blood, feces, colon tissue obtained during surgery)

Detailed description: To explore whether peptidoglycan fragments can be used as screening or diagnostic indicators for colorectal cancer

Eligibility criteria: Inclusion Criteria:

* People who underwent total colonoscopy in gastroenteroscopy room.
* People who agree to participate in this study and are willing to sign informed consent.

Exclusion Criteria:

* Previous diagnosis of malignant tumors other than colorectal cancer.
* Received any of the following drug treatments within 1 month before sample collection: ① Drugs used for the treatment of colorectal diseases; ② Antibiotics; ③probiotics; ④ Laxatives.
* Patients with a family history of colorectal cancer.

Primary outcomes:
measure: HPLC-MS/MS was used to detect peptidoglycan fragment content in biological specimens of 200 participants
timeFrame: baseline (before treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
Study officials:
affiliation: Southern Medical University, China
name: He Xiaolong, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02804412: Aphasia Therapy: Factors of Efficacy
Official title: Constraint Induced Aphasia Therapy in Stroke Patients in Acute Stage.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphasia
Keywords: communication disorders
language and speech disorder rehabilitation
stroke
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2016-06-17
Enrollment: 60
Sex: ALL
Minimum age (years): 39
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Constraint-induced aphasia therapy (CIAT) has proven effective in stroke patients. It has remained unclear, however, whether intensity of therapy or constraint is the relevant factor. This study will give an answer to this question to improve speech and language therapy.

Detailed description: Although there is clear evidence that aphasia therapy is effective, questions remain as to the intensity of administered therapy, the preferred therapeutic approach and its initiation with regard to stroke onset. CIAT is a a high intense group therapy administered over 2 weeks. Additionally, patients have to communicate solely in spoken words or sentences (constraint). This study compares CIAT with an approach of the same intensity without constraints and a less intense house-typical therapeutic approach.

Eligibility criteria: Inclusion Criteria:

* first ever stroke
* suffering from aphasia

Exclusion Criteria:

* severe cognitive or attentional impairments
* severe depression
* left-handedness
* severe dysarthria
* apraxia of speech
* severe deafness
* additional neurological diseases affecting speech (e.g. Parkinson's disease)

Primary outcomes:
measure: Change of aphasia by Aachener Aphasia Test (AAT)
timeFrame: pretreatment and within 24 h post intervention
Secondary outcomes:
measure: Change of Communication Activity Log (CAL)
timeFrame: pretreatment and within 24 h post intervention
Other outcomes:
Locations:
Study officials:
affiliation: NRZ Leipzig
name: Hartwig Woldag, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Woldag H, Voigt N, Bley M, Hummelsheim H. Constraint-Induced Aphasia Therapy in the Acute Stage: What Is the Key Factor for Efficacy? A Randomized Controlled Study. Neurorehabil Neural Repair. 2017 Jan;31(1):72-80. doi: 10.1177/1545968316662707. Epub 2016 Aug 9.
Clinical trial NCT03068312: A Study to Evaluate Efficacy of Ivacaftor in Subjects With Cystic Fibrosis Who Have a 3849 + 10KB C→T or D1152H CFTR Mutation
Official title: A Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Efficacy of Ivacaftor in Subjects With Cystic Fibrosis Who Are 6 Years of Age and Older and Have Either a 3849 + 10KB C→T or D1152H-CFTR Mutation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cystic Fibrosis
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2017-03-01
Enrollment: 38
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy of ivacaftor treatment in subjects with CF 6 years of age and older who have a 3849 + 10KB C→T or D1152H CFTR mutation.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of CF based on protocol-specified clinical features and at least one of the following: increased sweat chloride level, identification of 2 CF causing mutations, or demonstration of abnormal nasal epithelial ion transport.
* A 3849 + 10KB C→T or D1152H mutation on at least 1 CFTR allele.
* FEV1 ≥40% of predicted and ≤105% of predicted at screening.

Exclusion Criteria:

* A G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H mutation.
* History of any illness or any clinical condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject.
* Ongoing or prior participation in an investigational drug study within 30 days before the Screening Visit.
* Protocol-specified abnormal laboratory values at the Screening Visit
* For subjects \<18 years of age at the Screening Visit, evidence of cataract/lens opacity determined to be clinically significant by the ophthalmologist or optometrist during the ophthalmologic examination (OE) at the Screening Visit.
* Use of any moderate or strong inducers or inhibitors of cytochrome P450 (CYP) 3A, including consumption of certain herbal medications and certain fruit and fruit juices, within 14 days before Day 1.
* Pregnant, breastfeeding, or planning to become pregnant during the study.
* Sexually active subjects of reproductive potential must be willing to use appropriate contraception.

Primary outcomes:
measure: Change in Lung Clearance Index 2.5 (LCI2.5)
timeFrame: From baseline through 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
References:
citation: Kerem E, Cohen-Cymberknoh M, Tsabari R, Wilschanski M, Reiter J, Shoseyov D, Gileles-Hillel A, Pugatsch T, Davies JC, Short C, Saunders C, DeSouza C, Sullivan JC, Doyle JR, Chandarana K, Kinnman N. Ivacaftor in People with Cystic Fibrosis and a 3849+10kb C-->T or D1152H Residual Function Mutation. Ann Am Thorac Soc. 2021 Mar;18(3):433-441. doi: 10.1513/AnnalsATS.202006-659OC.
Clinical trial NCT04534712: Lymphocyte - Monocyte Ratio As An Independent Predictor For Progression Of Illness In Patients With Covid-19
Official title: Lymphocyte - Monocyte Ratio As An Independent Predictor For Progression Of Illness In Patients With Covid-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: LYMPHOCYTE MONOCYTE RATIO
COVID-19
DISEASE PROGRESSION
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
Collaborators: name: Sir Ganga Ram Hospital
First posted: 2020-09-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all patients who are tested positive for COVID 19 and presented within 7 days of symptom onset will be included

Brief summary: Corona virus disease 2019 (COVID 19), first identified in December 2019 in a cluster of population in a Chinese province, soon emerged as a pandemic, causing a huge strain on healthcare system and mortality all over the world. An ideal marker for predicting course of this illness should be easily available and reproducible; as the disease burden has spread to third world countries whose healthcare system is resource limited. Our study is aimed to study the utility of lymphocyte- monocyte ratio in the early stages to predict the progression of COVID 19 pneumonia.


Eligibility criteria: Inclusion Criteria:

* All adults of age 18-80 years tested positive for SARS-CoV-2 reverse-transcriptase - polymerase chain reaction (rt-PCR) and presented within 7 days of symptom(s) onset

Exclusion Criteria:

* Pregnancy
* Sepsis
* Malignancy
* Patients on immunosuppressant therapy
* Chronic inflammatory conditions
* Cases lost to follow up

Primary outcomes:
measure: progression
timeFrame: 28 days
Secondary outcomes:
measure: mortality
timeFrame: 28 days
Other outcomes:
Locations:
city: New delhi
country: India
facility: Sir Ganga Ram Hospital
state: Delhi
Study officials:
References:
Clinical trial NCT01436812: Effect of Positive End Expiratory Pressure (PEEP) on Cerebral Oxymetry During Laparoscopy
Official title: International Reveiw Board of Gachon Univerity Gil Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Ischemia
Keywords: cerebral oxymetry
laparoscopy
PEEP
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
First posted: 2011-09-20
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators hypothesized that positive end expiratory pressure (PEEP) would increase the regional oxygen saturation (rSO2).

Detailed description: The investigators hypothesized that PEEP would increase the rSO2 during laparoscopic surgery by improving oxygenation.

Eligibility criteria: Inclusion Criteria:

* ASA PS I or II adult patient undergoing laparoscopic low anterior resection with Trendelenburg position

Exclusion Criteria:

* Patients with history of cerebrovascular disease, coronary occlusive disease and/or obesity (body mass index \> 30) were excluded from this study.

Primary outcomes:
measure: cerebral ischemia
timeFrame: change from baseline in rSO2 at every events
Secondary outcomes:
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Hospital
Study officials:
affiliation: Gachon University Gil Medical Center
name: Hyun Jeong Kwak, MD.PhD
role: STUDY_CHAIR
affiliation: Gachon University Gil Medical Center
name: Youn Yi Jo, MD.PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01161212: REGULarity of Physical ActivitieS (REGUL'APS)
Official title: Physical Activity, Health-related Quality of Life and Corpulence Among French Schoolchildren
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Keywords: body mass index
health-related quality of life
physical education
children
cluster randomized controlled trial
prevention
Child
French
Schoolchildren
Lead sponsor: University of Nancy
Sponsor class: OTHER
Collaborators: name: IVRSP: Institut Virtuel de Recherche en Santé Publique
First posted: 2010-07-13
Enrollment: 1600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In French primary schools, children participate in 3 compulsory hours of physical education (PE) each week unless they have a medical contra-indication. But, there is no scientific evidence (randomized trial) that a weekly physical activity splitting up of these 3 hours of PE brings or not the same effects, particularly to prevent overweight or obesity.

Regul'aps is a cluster randomized controlled trial which wants to evaluate whether splitting up the 3 hours into 3 or 4 sessions (vs. 1-2 sessions) of PE per week has an effect on speed of a BMI increase and on health-related quality of life (HRQoL) over the school year.

Study hypothesis: reduction of speed of increase of BMI and an increase of HRQoL


Eligibility criteria: Inclusion Criteria:

* All teachers under the cover of the headmasters in charge of classes from grades 2 to 5 in 2 counties in the Lorraine region of France (Meurthe-et-Moselle and Vosges \[District of Golbey\])
* headmasters or teachers had to agree to modify the organisation of PE sessions

Exclusion Criteria:

* Classes composed only of 2d grade
* Set schedule of physical educational sessions

Primary outcomes:
measure: Body mass index (BMI) and waist circumference
timeFrame: September 2006 and June 2007
Secondary outcomes:
measure: Health-related quality of life
timeFrame: September 2006 and June 2007
Other outcomes:
Locations:
city: Vandoeuvre-Lès-Nancy
country: France
facility: Public health School, Laboratory EA4360 Apemac
Study officials:
affiliation: Public Health School, Laboratory EA4360 Apemac
name: Anne Vuillemin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05459012: Patient Education in Pregnant Women With Asthma
Official title: Patient Education: Asthma and Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2022-07-14
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women with asthma

Brief summary: Pregnancy may impact treatment adherence in women with asthma. This is a major risk factor for asthma exacerbation, which may have an important impact for both women and the babies. This study aims to evaluate the impact of a targeted patient education action tailored for pregnant women with asthma.


Eligibility criteria: Inclusion Criteria:

* Adult pregnant women with asthma

Exclusion Criteria:

* women not able to speak and/or read French language
* women protected by the law

Primary outcomes:
measure: Change from Asthma quality of life between two periods : before intervention and 3 month after the intervention
timeFrame: before and 3 month after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Chu Reims
Study officials:
References: