louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02084654: Exenatide and Weight Loss for Diabetes Prevention
Official title: Randomized Trial Investigating Exenatide for Diabetes Prevention in Obese, Insulin-Resistant Individuals With Prediabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pre Diabetes
Insulin Resistance
Keywords: prediabetes
exenatide
weight loss
insulin resistance
acute insulin response
insulin secretion
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2014-03-12
Enrollment: 66
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Exenatide, a GLP-1 agonist approved for lowering blood glucose concentrations in patients with type 2 diabetes, has been associated with restoration of the first-phase insulin response when administered intravenously to patients with type 2 diabetes. In longer clinical trials, it is associated with progressive decreases in body weight, and improvement in the dyslipidemia that characterizes insulin resistance, although insulin resistance was not quantified. The investigators will seek to determine whether exenatide would have similar effects in individuals who were not diabetic. in particular, the drug effect on beta cell function and insulin sensitivity would be subject to less confounding by changes in blood glucose in the prediabetic population, allowing for clearer evaluation of the physiological effects of the drug on these metabolic endpoints. The investigators will compare 2 groups of prediabetic insulin resistant individuals, all on a weight loss diet and one group on exenatide and the other on placebo. The investigators will evaluate restoration of first phase insulin response, potential glucose lowering effects, including both reversal of prediabetes and hypoglycemia, and improvement in insulin resistance.


Eligibility criteria: Inclusion Criteria:

* Healthy Men and women, BMI 27-37kgm2, Fasting plasma glucose = or \> 100 mg/dL and = or \< 99 125m g/dl or a 2 hour post OGTT = \> 140 mg/dl or = or \< 199 mg/dl

Exclusion Criteria:

* Diabetes, Active cardiac, kidney, liver, pulmonary, or other major organ diseases are cause for exclusion. Other exclusionary criteria include: use of corticosteroids, diet medications, antipsychotic medications, history of eating disorder, history of bariatric surgery, active malignancy, recent weight change of more than 2%, inability to attend follow-up visits, excessive alcohol use, investigator's discretion that it is not in patient's best interest

Primary outcomes:
measure: First-phase insulin response
timeFrame: 7 months
Secondary outcomes:
measure: glucose lowering effect
timeFrame: 8 months
Other outcomes:
measure: insulin-mediated glucose uptake (insulin sensitivity)
timeFrame: 8 months
Locations:
Study officials:
affiliation: Stanford University
name: Tracey McLaughlin, MS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01979354: 0.15 mg Spinal Morphine vs. no Treatment for Morphine Requirement After VATs.
Official title: The Comparison of 0.15 Milligram Spinal Morphine vs.no Treatment for Morphine Requirement After Video-assisted Thoracoscopic Surgery. A Pilot Randomized Control Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: spinal morphine
VATs lobectomy
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2013-11-08
Enrollment: 40
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: Postoperative pain after Video-assisted Thoracoscopic Surgery (VAT) is still debating. Therefore the investigators conduct a study comparing 0.15 mg spinal morphine and control group in term of analgesia.


Eligibility criteria: Inclusion Criteria:

* Age 18 year or over
* Patient ASA physical status I-III.
* Scheduled for video-assisted thoracoscopic lobectomy or blebectomy with pleurectomy or pleural abrasion
* Can operate a patient-controlled analgesia (PCA) device.

Exclusion Criteria:

* Known hypersensitivity to morphine
* History of bleeding tendency.
* Known case of infection at the back
* Patient refuse for spinal anesthesia
* History of cerebrovascular disease.
* Need mechanical ventilatory support during postoperative period

Primary outcomes:
measure: Total morphine requirement in 48 hours
timeFrame: 48 hours
Secondary outcomes:
measure: Pain
timeFrame: 48 hours
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Mahidol University
Study officials:
affiliation: Mahidol University
name: Sirilak Suksompong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01950754: Study of the Effect of a Cognitive Task on Static Balance in Depressive Elderly Subjects According to the Double Task Principle
Official title: Study of the Effect of a Cognitive Task on Static Balance in Depressive Elderly Subjects According to the Double Task Principle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2013-09-25
Enrollment: 30
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study could contribute to understanding the aggravation of balance disorders and the increased risk of falling in depressive people. It could, among other things, shed light on the impact of treatments with antidepressants on balance in treated depressive patients. Finally, it could contribute to improving the sensory-motor management of patients with a depressive syndrome.


Eligibility criteria: Inclusion Criteria:

In the 2 groups:

* General and cognitive status allowing the patient, according to the evaluation of the investigators, to take part in the study.
* Patients who provide written informed consent
* Patients covered by the national health insurance agency

In the "depression " group:

* Age ≥ 75 years,
* Subjects with a depressive syndrome, according to Geriatric Depression Scale criteria.
* Patients without treatment with antidepressants

In the "control" group:

* Age ≥ 75 years,
* Absence of a depressive syndrome

Exclusion Criteria:

In the 2 groups:

* Presence of a disabling orthopedic disease,
* Presence of any chronic neurological disease (cerebrovascular accident, Parkinson's syndrome ...),
* Presence of a psychiatric disease apart from depression in the " depression " group
* Presence of a vestibular disease with clinical manifestations,
* Presence of a non-corrected visual disorder,
* Existence of a progressive organ disease,
* Psychotropic treatment able to impair vigilance and posture,
* Notion of one or several falls in the preceding 6 months,
* Oppositional personality or low motivation,
* Emotional or intellectual disorder.
* Patients under guardianship
* Patients who have taken part in a therapeutic trial in the previous 30 days

Primary outcomes:
measure: the difference in distance traveled by moving the center of pressure between the simple task and the dual task
timeFrame: up to 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon
Study officials:
References:
Clinical trial NCT03796754: YoBEKA Program (Yoga, Movement, Relaxation, Concentration and Mindfulness) in Elementary Schools
Official title: Integration of the YoBEKA Program (Yoga, Movement, Relaxation, Concentration and Mindfulness) Into Elementary Schools in Germany
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2019-01-08
Enrollment: 250
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is a first evaluation of the effectiveness of the YoBEKA Program (Yoga, Movement, Relaxation, Concentration and Mindfulness) to evaluate potential effects in stress reduction and concomitant psychological parameters.


Eligibility criteria: Inclusion criteria:

* Students from participating primary schools in Berlin aged 6-12 years
* Written declaration of consent of the parent or legal guardian

Exclusion criteria:

* Serious chronic or acute diseases
* Immobility or serious restriction for gymnastic exercises due to orthopaedic, neurological or other medical causes
* Participation in another study

Primary outcomes:
measure: Questionnaire on the assessment of stress and stress management in childhood and adolescence - Revision (SSKJ 3-8 R)
timeFrame: Change baseline, 4 months
Secondary outcomes:
measure: Inventory of the quality of life of children and adolescents (KIDSCREEN-27 children)
timeFrame: Change Baseline, 4 months, 12 months
measure: Perceived Stress Scale (PSS)
timeFrame: Change Baseline, 4 months, 12 months
measure: Teacher anxiety and stress inventory (LASI)
timeFrame: Change Baseline, 4 months, 12 months
measure: Screening for somatoform disorders of childhood and adolescence (SOMS-E)
timeFrame: Change Baseline, 4 months, 12 months
measure: Inventory of the quality of life of children and adolescents (KIDSCREEN-52 parents)
timeFrame: Change Baseline, 4 months, 12 months
Other outcomes:
measure: Heart rate variability
timeFrame: Baseline, 4 months, 12 months
measure: Qualitative interviews
timeFrame: 4 months, 12 months
Locations:
city: Berlin
country: Germany
facility: Charite University
Study officials:
References:
Clinical trial NCT03610854: Fitness Trackers During and After Oncological Treatments
Official title: Pilot Study for the Continuous Assessment of Biological Parameters Using a Fitness Tracker Before, During and After Radiochemotherapy or Chemotherapy in Patients With Oncological Diseases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Physical Activity
Fatigue
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2018-08-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The overall goal of the present trial is to evaluate the patients' compliance for wearing a commercially available fitness tracker during and after oncological treatments.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed malignant disease
* Upcoming chemotherapy of radiochemotherapy
* Eastern Co-operative Oncology Group (ECOG) performance score 0-2

Exclusion Criteria:

* Pre-existing comorbidities that impair patient mobility.
* Eastern Co-operative Oncology Group (ECOG) performance score 3-4

Primary outcomes:
measure: Compliance for wearing the fitness tracker
timeFrame: Four weeks after the end of radiotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University Hospital Tübingen
Study officials:
References:
Clinical trial NCT00420654: Growth Hormone Treatment of Women With Turner Syndrome
Official title: Growth Hormone Treatment of Women With Turner Syndrome: Body Composition and Heart Function.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Turner Syndrome
Keywords: Turner syndrome
growth hormone treatment
positron emission tomography
heart
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2007-01-11
Enrollment: 24
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Growth hormone treatment is used in girls with Turner syndrome to increase final height. The aim of this study is to evaluate the effect of growth hormone treatment on body composition and heart function in adult women with Turner syndrome. The hypothesis is that the fat mass will decrease and lean body mass will increase. There is only very limited documentation of the effect on the heart in this study population.

Detailed description: This study is a randomised, double-blinded, controlled clinical trial to evaluate the effect of growth hormone (GH) treatment on adult women with Turner syndrome. The endpoints will be changes in body composition and heart function evaluated by echocardiography (ECHO) and positron emission tomography (PET).

Phase one: 6 months of GH or placebo treatment. Phase two: "open label" all participants are treated with GH for 12 months. At baseline, healthy controls will be examined, but will not receive any treatment

Eligibility criteria: Inclusion Criteria:

* Turner syndrome
* Age 20-40

Exclusion Criteria:

* Symptomatic heart disease
* Anti hypertensive treatment
* Untreated thyroid disease
* Adipositas (BMI \> 35)
* Treatment with glucocorticoids
* Pregnancy

Primary outcomes:
measure: Body composition: fat mass and lean body mass
timeFrame: 6 months + 18 months
measure: Myocardial perfusion and glucose uptake, evaluated by positron emission tomography
timeFrame: 6 months
Secondary outcomes:
measure: Heart function evaluated by echocardiography (conventional and tissue doppler)
timeFrame: 6 months + 18 months
measure: Lipid profile
timeFrame: 6 months + 18 months
measure: 24 hour ambulatory blood pressure
timeFrame: 6 months + 18 months
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Medical Department M (Endocrinology and Diabetes), Aarhus University Hospital
state: DK
Study officials:
affiliation: University of Aarhus
name: Jens S. Christiansen, prof. dr.med
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06928454: Brain Health Project for Korean American Dementia Caregivers
Official title: INFORMED: Brain Health Project for Korean American Dementia Caregivers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Caregiving Stress
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2025-04-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The caregivers of persons with dementia face significant emotional, physical, and financial challenges, particularly among under-resourced communities like Korean Americans, who encounter unique obstacles, including language barriers and limited culturally tailored resources. In this pilot study, the investigators propose the Brain Health Project, which focuses on increasing knowledge of Alzheimer's disease and related dementia and enhancing caregiving skills among Korean American dementia caregivers.


Eligibility criteria: Inclusion Criteria:

* age 18 and older
* self-identified as Korean American
* able to read and/or speak English or Korean
* care for a person with undiagnosed or diagnosed dementia for the last 6 months
* have access to a mobile phone to receive text messages

Exclusion Criteria:

* planning a trip out of the United States during the next four months

Primary outcomes:
measure: Dementia Knowledge Assessment Tool 2 (DKAT2)
timeFrame: Baseline and through study completion, an average of 9 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Ji Won Choi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03868254: Chart Review of XEN 45 Gel Stent: Long Term Performance and Safety Assessment (XEN LT)
Official title: XEN 45 Gel Stent: Long Term Performance and Safety Assessment (XEN LT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2019-03-11
Enrollment: 174
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participant eyes that underwent XEN 45 Gel Stent implantation from 1 January 2014 until 1 October 2015.

Brief summary: A retrospective, non-interventional, observational, multi-center, chart review study to be conducted in participants who underwent placement of the XEN 45 Gel Stent as a standalone procedure or in combination with phacoemulsification from 1 January 2014 to 1 October 2015.


Eligibility criteria: Inclusion Criteria:

* Eye treated with XEN 45 Gel Stent for primary open angle glaucoma as a standalone procedure or in combination with phacoemulsification
* XEN 45 Gel Stent was implanted between 1 January 2014 and 1 October 2015

Exclusion Criteria

* None

Primary outcomes:
measure: Change From Baseline in Mean Intraocular Pressure (IOP) to 36 Months After Implantation
timeFrame: Baseline (Day decision was made to implant XEN 45 Gel Stent) to 36 months after implantation
measure: Change From Baseline in the Number of Topical IOP-lowering Medications 36 Months After Implantation
timeFrame: Baseline (Day decision was made to implant XEN 45 Gel Stent) to 36 months after implantation
Secondary outcomes:
measure: Change From Baseline in Mean IOP to 48 Months After Implantation
timeFrame: Baseline (Day decision was made to implant XEN 45 Gel Stent) to 48 months after implantation
measure: Change From Baseline in the Number of Topical IOP-lowering Medications 48 Months After Implantation
timeFrame: Baseline (Day decision was made to implant XEN 45 Gel Stent) to 48 months after implantation
measure: Percentage of Eyes Achieving Qualified Success at Month 36
timeFrame: Baseline (Day decision was made to implant XEN 45 Gel Stent), Month 36
measure: Percentage of Eyes Achieving Qualified Success at Month 48
timeFrame: Baseline (Day decision was made to implant XEN 45 Gel Stent), Month 48
measure: Percentage of Eyes Achieving Complete Success at Month 36
timeFrame: Baseline (Day decision was made to implant XEN 45 Gel Stent), Month 36
measure: Percentage of Eyes Achieving Complete Success at Month 48
timeFrame: Baseline (Day decision was made to implant XEN 45 Gel Stent), Month 48
measure: Percentage of Eyes With Adverse Events of Special Interest (AESIs)
timeFrame: Baseline (Day decision was made to implant XEN 45 Gel Stent) to approximately 51 Months
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Clinical Trials Registry Team
state: California
Study officials:
affiliation: Allergan
name: Mini Balaram, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05432154: An Innovative Silicone Wound Dressing for the Management of Atrophic Vaginitis
Official title: Efficacy and Safety of a Novel Silicone Wound Dressing for the Management of Atrophic Vaginitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrophic Vaginitis
Lead sponsor: Stratpharma AG
Sponsor class: INDUSTRY
First posted: 2022-06-27
Enrollment: 10
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of the study is to determine the efficacy of 7-0940 in the management of atrophic vaginitis in female patients


Eligibility criteria: Inclusion Criteria:

* Able to provide informed consent
* Diagnosed acute or chronic Atrophic Vaginitis
* Controlled disease, or uncontrolled disease that did not respond to standard therapy with HRT

Exclusion Criteria:

* Unable to provide informed consent
* Patient unable to apply topical device
* Allergy or intolerance to ingredients or excipients of the formulation of studied products
* Currently on HRT (orally or topically)
* Currently on corticosteroid treatment

Primary outcomes:
measure: Patient-reported Vulvar Quality of Life
timeFrame: 3 months
Secondary outcomes:
measure: Patient-reported symptoms
timeFrame: 3 months
measure: Severity of overall condition
timeFrame: 3 months
measure: Product rating
timeFrame: 3 months
Other outcomes:
Locations:
city: Laguna Hills
country: United States
facility: Orange Coast Women's Medical Group
state: California
Study officials:
References:
Clinical trial NCT00834054: Measurement of Lung Water by Transpulmonary Thermodilution in Lung Transplanted Patients
Official title: Interest of Repeated Extravascular Lung Water Measurements With the PICCO Device in Lung Transplanted Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mucoviscidosis
Pulmonary Insufficiency
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2009-02-03
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: double-lung transplanted patients

Brief summary: Repeated measurements of lung water by single transpulmonary thermodilution during the first postoperative days following lung transplantation


Eligibility criteria: Inclusion Criteria:

* double-lung transplanted patients

Exclusion Criteria:

* none

Primary outcomes:
measure: extra-vascular lung water
timeFrame: first postoperative days
Secondary outcomes:
measure: pulmonary permeability index
timeFrame: first postoperative days
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
affiliation: Hopital Foch
name: Charles Cerf, MD
role: STUDY_CHAIR
References: