louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01579773: Comparison of Body Composition & Weight Change in Users of Progestin-only Contraception During the First Year of Use
Official title: Comparison of Body Composition & Weight Change in Users of Progestin-only Contraception During the First Year of Use
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Weight Change
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2012-04-18
Enrollment: 345
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who are starting an IUD or implant through their provider could be eligible.

Brief summary: The purpose of this study is to learn if women gain weight using progestin-only methods of contraception and if so, how much. The investigators will look at users of two progestin-only methods: the levonorgestrel-containing intrauterine contraceptive (LNG-IUC) and the etonorgestrel (ENG) subdermal implant, and compare these users' weight change to that of users of a non-hormonal method, the copper intrauterine device.

The primary hypothesis is that ENG implant and LNG-IUC users' weight and body composition will increase more than the copper-IUD users. The investigators will collect body composition data using dual-energy x-ray absorptiometry (DEXA), and collect information about diet and activity using validated questionnaires.


Eligibility criteria: The study has finished enrolling new participants.

Inclusion Criteria:

* Participants between the ages of 18 and 45 years
* Participants starting the copper IUD or implant through their provider
* First study visit must occur within 14 days of method insertion

Exclusion Criteria:

* DMPA in the past 16 weeks
* POPs, LNG-IUC, or the implant in the past 4 weeks
* Thyroid disease
* Autoimmune disease
* Diabetes (excluding gestational)
* History of eating disorder
* Currently taking antidepressants for \< 6 months
* Currently taking antipsychotics
* Currently taking oral glucocorticoids (steroids, i.e. prednisone) for more than 6 months
* Currently breastfeeding
* Less than 6 months post-partum

Primary outcomes:
measure: Weight
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Body composition
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Tessa E Madden, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00760331: Long Term Follow up of a Cohort of Children With TCF2 Mutation:Evolution of Endocrine and Renal Function
Official title: A Long Term Follow up of a Cohort of Children With TCF2 Mutation:Evolution of Endocrine and Renal Function
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hepatocyte Nuclear Factor 1-beta
Keywords: HNF1B
TCF2
MODY-5
CAKUT
Anomaly of renal development
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2008-09-26
Enrollment: 100
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatric patients presenting an abnormality of kidney developmentdue to TCF2 mutation or deletion.

Brief summary: Anomalies of renal development are well know for patients treated for MODY-5 diabetes due to TCF2 mutation.A recent study confirms the existence of pediatric patients having TCF2 mutation but presenting renal anomalies alone.Endocrine and renal evolution of these patients is unknown.The aim of this study is to follow a cohort of patients with TCF2 mutation and initially presenting renal anomalies alone.

Detailed description: Biologic analysis and renal ultrasonography once a year.

After puberty or before kidney transplantation

* Abdominal and pelvic MRI
* Intravenous Glucose Tolerance Test

Eligibility criteria: Inclusion Criteria:

* Patients presenting an anomaly of renal development due to TCF2 mutation
* Age\<18 years old

Exclusion Criteria:

* Anomaly of renal development without TCF2 mutation
* Age≥18 years old
* Parents or patients refusing to participate to the study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Limoges
country: France
facility: CHU de Limoges
Study officials:
affiliation: University Hospital, Limoges
name: Vincent GUIGONIS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04322331: Tumor Immune Mechanism of Axillary Lymph Node Metastasis in Early Luminal Type A Breast Cancer
Official title: The Different Transcriptional Characterization Of The Tumor Immune Microenvironment of Luminal A Breast Cancer With Different Lymph Node Metastasas Status
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Immune Microenvironment
Luminal A
Lymph Node Metastases
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2020-03-26
Enrollment: 120
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: invasive breast cancer patients with Luminal A type. Stage T1N1/T1N2/T1N3 are in group 1; stage T2N0/T3N0 are in group 2

Brief summary: Luminal type A breast cancer is a type with good clinical prognosis, and the proportion of lymph node metastasis is low, but a small number of patients have more lymph node metastasis when the primary tumor is very small, and the survival is poor, suggesting that this part of Luminal A breast cancer has the different expression of some genes from that of general Luminal A breast cancer, which affects tumor invasion and participates in the occurrence of tumor metastasis. But the mechanism is not clear, especially in the current tumor microenvironment and immune related mechanisms.We want to investigated the relationship of the transcriptional tumor immune microenvironment with early lymph node metastasis among Luminal A type breast cancer.


Eligibility criteria: Inclusion Criteria:

* invasive breast cancer with Luminal A type;T1 with positive lymph node or T2/T3 with negative lymph node

Exclusion Criteria:

* Missing specimen

Primary outcomes:
measure: Transcriptional Characterization
timeFrame: 2020-12
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking university people's hospital
Study officials:
References:
Clinical trial NCT04202731: Sleep, Insulin Sensitivity, and Weight in Adolescents Post-bariatric Surgery
Official title: Sleep, Insulin Sensitivity, and Weight in Adolescents Post-bariatric Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sleep
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2019-12-18
Enrollment: 5
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Assessing sleep and circadian health in severely obese adolescents undergoing bariatric surgery and examine relation to health outcomes including insulin sensitivity and percent weight loss to date at 1-year and evaluate the impact of sleep extension on health outcomes in this population.


Eligibility criteria: Inclusion Criteria:

* ages 12-21 years
* attending high school or middle school (peak period for insufficient and delayed sleep)
* completion of bariatric surgery procedure (i.e., vertical sleeve gastrectomy) within the past 2 years but not less than 6 months prior to study participation
* All must also be Tanner Stage 5

Exclusion Criteria:

* regular use of medications affecting sleep (e.g., stimulants, atypical antipsychotics, melatonin or other sleep aids) or insulin resistance (systemic steroids, other oral diabetes medications)
* HbA1c ≥6.5%
* intelligence quotient (IQ) \<70 or severe mental illness

Primary outcomes:
measure: Sleep duration
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: University of Colorado Denver | Anschutz
name: Jill L Kaar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04903431: Assessing the Effectiveness of Self- and Clinician-administered Crisis Response Planning for Suicide Risk
Official title: Assessing the Effectiveness of Self- and Clinician-administered Crisis Response Planning for Suicide Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide, Attempted
Suicidal Ideation
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2021-05-26
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the current project is to compare the use and preliminary effectiveness of a self-administered version of the Crisis Response Plan (CRP) in decreasing suicidal/death ideation and distress and increasing positive affect when compared to a clinician-administered version of the protocol in a sample of 150 military Veterans experiencing current death or suicidal ideation.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* US military veteran
* death or suicidal ideation/suicide attempt within the past month

Exclusion Criteria:

* non-Veteran status
* acute intoxication or active psychosis precluding provision of informed consent
* inability to communicate and comprehend English
* residence outside the United States
* lack of past-month death/suicide ideation or attempt
* lack of device connected to webcam or internet

Primary outcomes:
measure: Change in Suicide Visual Analog Scale scores from the previous daily assessment
timeFrame: Administered daily for eight consecutive days
Secondary outcomes:
measure: Change in Patient Health Questionnaire - 2 scores from the previous daily assessment
timeFrame: Administered daily for eight consecutive days
measure: Change in Positive and Negative Affect Schedule - Short Form scores from the previous daily assessment
timeFrame: Administered daily for eight consecutive days
measure: Change in Crisis Response Plan Use from the previous daily assessment
timeFrame: Administered daily for eight consecutive days
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
References:
Clinical trial NCT05263531: Remote Ischemic Conditioning for Motor Recovery After Acute Ischemic Stroke
Official title: The Safety and Efficacy of Remote Ischemic Conditioning on Motor Recovery After Acute Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemic Stroke
Keywords: remote ischemic conditioning
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The most recent treatment for stroke rehabilitation is to combine physical training with other therapies to enhance or accelerate recovery.The hypothesis of this study is that remote ischemic conditioning (RIC) might have a beneficial effect on motor recovery of AIS

Detailed description: Despite the effective reperfusion therapies ,acute ischemic stroke(AIS) is still one of the leading causes of disability, resulting in an economic burden. Multidisciplinary rehabilitation has benefit effects on motor recovery and remains the first-line intervention strategy for attenuating motor function impairments. However, the effect of the physiotherapy application alone is not satisfactory, The potential treatment effect of RIC on motor recovery of AIS has not been investigated. The investigators designed this randomized clinical trial to examine whether RIC has a beneficial effect on poststroke motor function recovery.There are 2 arms in this trial: One arm is RIC treatment, the other one is sham RIC treatment. The motor function will be assessed by Fugl-Meyer Motor Scale before and after the treatment to evaluate its exact effect on motor recovery.

Eligibility criteria: Inclusion Criteria:

1. Subjects aged 18-80 years;
2. First-ever unilateral ischemic stroke,5\~10 days after onset;
3. Had motor dysfunction caused by stroke(Fugl-Meyer≤55)
4. mRS≤1 before stroke
5. NIHSS 6\~20
6. Written consent was obtained from the subject.

Exclusion Criteria:

1. Cannot complete assessments-ie, psychiatric disorders, sensory aphasia, dementia
2. brainstem lesion or cerebellun lesion
3. poorly controlled diabetes mellitus
4. Application of agent which thought to impair or improve recovery based on laboratory and clinical evidence within 1 month (ie,DA,MAOI, SSRI,α1/α2 adrenergic receptor inhibitors,BZD,etc)
5. severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs.

Primary outcomes:
measure: changes in Fugl-Meyer score
timeFrame: 0-3 months
Secondary outcomes:
measure: Changes of the level of angiogenesis related factors
timeFrame: 0-3 months
measure: changes in Barthel Index
timeFrame: 0-3months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuan Wu Hospital,Capital Medical University
state: Beijing
Study officials:
affiliation: Capital Medical University Xuan Wu Hospital
name: Xunming Ji, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01163331: Singing in Groups for Parkinson's Disease; A Pilot Study of Group Singing Therapy for PD-related Voice/Speech Impairment
Official title: Singing in Groups for Parkinson's Disease; A Pilot Study of Group Singing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Voice Quality and Voice Loudness Associated With Parkinson's Disease
Keywords: Parkinson's Disease, voice quality, vocal strength, voice loudness
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Michael J. Fox Foundation for Parkinson's Research
First posted: 2010-07-15
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will compare group singing to group speech therapy without singing. You may be eligible for this study if you have been diagnosed with PD for one year or more and you have a quiet voice or difficulty being understood.

Detailed description: The National Parkinson Foundation Center of Excellence at Beth Israel Deaconess Medical Center is conducting a research study to test whether group singing therapy helps people with voice or speech disorders due to Parkinson's disease (PD). Communication problems, including loss of vocal loudness, affect many people with PD. While existing forms of speech therapy have been shown to be helpful, group singing may be a beneficial alternative to traditional speech therapy.

The study will involve participating in weekly treatment sessions where subjects will receive training in vocal exercises from a speech-language pathologist with expertise in PD, as well as instructions for structured home practice. Participants will be assigned to a singing or non-singing group for the 12-week treatment phase of the study. Researchers will measure subjects' vocal function and communication-related quality of life before and several times after the 12-week program. All subjects and their care partners are welcome to participate in a singing group following the study.

You may be eligible for this study if you have been diagnosed with PD for one year or more, and you have difficulty with your voice or speech such as quiet voice, or difficulty being understood.

Eligibility criteria: Inclusion Criteria:

* Difficulty being heard or understood
* Diagnosis of Parkinson's Disease for one year

Exclusion Criteria:

* No other neurological conditions(i.e. stroke, cerebellar ataxia) that affect voice quality
* No history of vocal chord hemorrhage

Primary outcomes:
measure: Vocal Loudness, Vocal Quality
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
References:
Clinical trial NCT00549731: Participant Database for Autism Research Studies
Official title: Database for Persons Interested in Research Studies of Developmental Disorders
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Autism Spectrum Disorder
Keywords: autism
autistic
language
development
developmental
assessment
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: National Institutes of Health (NIH)
First posted: 2007-10-26
Enrollment: 120
Sex: ALL
Minimum age (years): 14
Maximum age (years): 32
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult/Pediatric

Brief summary: The purpose of this study is to create a subject database to recruit for current and future studies in research on autism and other neurodevelopmental disabilities.

Detailed description: Aim 1: to recruit people interested in research on autism and other neurodevelopmental disabilities

Aim 2: to complete a diagnostic assessment, to confirm the diagnosis of autism spectrum disorder or other developmental disability (e.g., developmental language delay) in our patient population and rule out a diagnosis of autism spectrum disorder and other comorbid conditions in our control group

Aim 3: to maintain subject information in a database, from which we can recruit for our studies

Eligibility criteria: Inclusion Criteria:

* Typically-developing, healthy adolescents and adults (ages 14-32)
* Adolescents and adults with autism spectrum disorder (ages 14-32)

Exclusion Criteria:

* Extreme premature birth (\<34 weeks)
* Known genetic disorders related to autism (e.g. Fragile X)
* Recent diagnosis of psychosis (within 6 months)
* Some other psychiatric diagnoses may be excluded following screening (e.g. Tourette's syndrome).
* Metal implants / permanent retainers / hair dyes with metallic components

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Martinos Center of Biomedical Imaging
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Tal Kenet, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03543631: Survey on Precision Medicine and Digital Health
Official title: Survey on Precision Medicine and Digital Health
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Health Behavior
Health Knowledge, Attitudes, Practice
Health Attitude
Lead sponsor: Scripps Health
Sponsor class: OTHER
First posted: 2018-06-01
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Anyone who access and is interested in participating in the online survey.

Brief summary: The investigators have created an anonymous online survey that queries current topics in precision medicine.

Detailed description: The investigators have created an anonymous online survey to assess the educational requirements and current gaps in knowledge related to advances in precision medicine. These include questions that focus on digital health, wearable technologies, genetic sequencing, and CRISPR to assess survey participants' interest and knowledge level.

Eligibility criteria: Inclusion Criteria:

* Students and physicians at all levels of training.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Precision medicine
timeFrame: August 2018 - November 2018
Secondary outcomes:
measure: Digital health
timeFrame: August 2018 - November 2018
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Green Hospital
state: California
Study officials:
affiliation: Scripps Health
name: Xia Bi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03646331: Bioequivalence of Imeglimin Tablet Formulations
Official title: A Phase I, Open-label, Randomised, Single-centre, 2-way Crossover Bioequivalence Study Comparing 2 Formulations of Imeglimin After Single Oral Doses in Healthy Caucasian Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bioequivalence
Lead sponsor: Poxel SA
Sponsor class: INDUSTRY
First posted: 2018-08-24
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is an open-label assessment of the bioequivalence of two 500 mg-tablet formulations of imeglimin (Tablet A \[reference product\] and Tablet B \[test product\]), in at least 16 healthy Caucasian volunteers.


Eligibility criteria: Inclusion Criteria:

* BMI : 18.5-29.9
* Body weight ≥ 60 kg
* willing to use reliable contraception
* able to give fully informed written consent.

Exclusion Criteria:

* Positive tests for hepatitis B \& C, HIV
* severe adverse reaction to any drug; sensitivity to trial medication and/or food allergies
* drug or alcohol abuse
* smoking of more than 5 cigarettes daily or drinking more than 5 cups of caffeinated drinks daily
* over-the-counter medication, vitamins and herbal remedies, or prescribed medication in the 20 days before the first dose of trial medication (with the exception of paracetamol \[acetaminophen\] and oral contraception);
* participation in other clinical trials of unlicensed medicines, or loss of more than 400 mL blood, within the previous 3 months
* vital signs outside the acceptable range
* clinically relevant abnormal findings at the screening assessment; estimated glomerular filtration rate (eGFR) at screening \< 80 mL/min/1.73 m2
* acute or chronic illness
* clinically relevant abnormal medical history or concurrent medical condition;
* surgery or medical condition that might affect the absorption of medicines;
* possibility that volunteer will not cooperate
* pre-menopausal females who are pregnant or lactating, or who are sexually active and not using a reliable method of contraception;
* objection by the volunteer's General Practitioner (GP).

Primary outcomes:
measure: Pk parameters of imeglimin
timeFrame: from dosing up to 48h
Secondary outcomes:
measure: PK parameters of Imeglimin
timeFrame: from dosing up to 48h
measure: Incidence of treatment emergent adverse events (Safety and tolerability)
timeFrame: From Day 1 to Day 15
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Hammersmith Medicines Research (HMR)
Study officials:
References: