louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01848509: Telemedicine for Sleep Apnea Patients
Official title: A Telemedicine System for the Follow-up of Patients With SAS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea
Keywords: CPAP
adherence
SAOS
telemedicine
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2013-05-07
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Objective: Set up an interoperable telemedicine system for the follow-up of patients with sleep apnea syndrome.

Detailed description: The medico-economics protocol will use the MAST (Methodology for Assessment of Telemedicine) criteria. 200 patients will be randomized into 2 arms (telemedicine with GPRS transmission of CPAP data from patients' home and classical follow-up) during the 3 first months of the follow-up. The main end-point is CPAP compliance with the aim of detecting a mean increase of at least 1hr in the use of CPAP.

Eligibility criteria: Inclusion Criteria:

* AHI \> 30/hr
* hypersomnolence
* agreement for the use of CPAP
* internet and GSM connection

Exclusion Criteria:

* central apnea \>20%,
* pneumothorax,
* severe nasal obstruction,
* previous pharyngeal surgery,
* severe COPD,
* heart failure,
* previous use of CPAP,
* no social security coverage,
* unavailability,
* no GSM and internet network

Primary outcomes:
measure: CPAP adherence measured by the number of hours of nightly use
timeFrame: 3 Months
Secondary outcomes:
measure: economics: cost estimation: investment and running costs
timeFrame: 3 months
measure: Quality of life
timeFrame: 3 months
measure: Organizational changes of home care providers and medical structures
timeFrame: 9 months after the first patient inclusion
measure: Perception of healthcare professionals (autoquestionnaire RENEWING HEALTH)
timeFrame: 3 months
measure: Patients satisfaction
timeFrame: 3 months
Other outcomes:
Locations:
city: Clamart
country: France
facility: Assistance Publique - Hôpitaux de Paris, Béclère Hospital
Study officials:
affiliation: AP-HP - Antoine Béclère Hospital
name: Pierre ESCOURROU, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00154609: Davallia Divaricata BL: The Use of Traditional Chinese Native Medicine for Osteoporosis
Official title: The Use Tradition Chinese Native Medicine Treats the Osteoporosis Research
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Osteoporosis
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 100
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We, the investigators at National Taiwan University Hospital, have determined the therapeutic and toxic effects of the traditional herb on the ovariectomized Wistar rat.

The final years will determine its effects on the therapy of women who are over 45 years old and postmenopausal with osteoporosis.

Detailed description: Research of this traditional chinese clinical medicine, Gusuibu, curative effect is planned for three years time. The entire study aims to evaluate the effect of the traditional chinese medicine on postmenopausal osteoporosis as well as the possible side effects on the experimental animal and the human body. All subjects were postmenopausal women with established osteoporosis.

Eligibility criteria: Inclusion Criteria:

* Postmenopausal osteoporosis

Exclusion Criteria:

* Insulin dependent diabetes

Primary outcomes:
measure: The project is aimed to investigate the clinical effects of the water extract of Gu-Sui-Bu from the aspects of animal and clinic studies.
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Medical Center
state: 7, Chung-Shan South Road
Study officials:
affiliation: National Taiwan University Medical Center
name: Liu Hwa-Chang, Ph.D
role: STUDY_CHAIR
References:
Clinical trial NCT02921009: McNeel Eye Center Corneal Crosslinking Study
Official title: Study of Effectiveness and Safety of Transepithelial Collagen Cross-linking at Varying Fluence Levels.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Keratoconus
Lead sponsor: McNeel Eye Center
Sponsor class: INDUSTRY
First posted: 2016-09-30
Enrollment: 100
Sex: ALL
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will investigate the effectiveness in treating keratoconus, pellucid marginal degeneration and post LASIK iatrogenic ectasia utilizing fluence rates and treatment times of Corneal Cross Linking other than the original FDA approved protocol of 3mw/cm2.

Detailed description: Patient recruitment will include a patient population of 100 individuals from 15 years to 50 years old with established keratoconus, pellucid marginal degeneration or post-LASIK ectasia determined by keratography. A solution of transepithelial riboflavin .25% will be applied every three minutes for 30 minutes or until complete corneal penetration is observed. Then the cornea will be irradiated with UV light at fluence rates of 9mw/cm2 for 10 minutes or 18 mw/cm2 for 5 minutes. Post procedural evaluation will take place at day one, day 7 day 30, day 90, day 180 and day 365. Pretreatment keratography, uncorrected acuity, best corrected acuity will be compared at follow up days beginning on day 30.

Eligibility criteria: Inclusion Criteria:

* Males or females between the ages of 15 and 50 with keratoconus diagnosed topographically with or without other corneal ectatic disease.

Exclusion Criteria:

* Prior corneal transplantation, pregnancy, inability or unwillingness to adhere to follow up protocol.

Primary outcomes:
measure: Post treatment topographic analysis of Crosslinked patients
timeFrame: One Year
Secondary outcomes:
measure: Post Treatment Best Corrected Visual Acuity
timeFrame: One Year
Other outcomes:
Locations:
city: Boise
country: United States
facility: McNeel Eye Center
state: Idaho
Study officials:
affiliation: McNeel Eye Center
name: Brian J McNeel, OD
role: STUDY_DIRECTOR
affiliation: The Eye Associates
name: Gregory Kent, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01355809: Six-Minute Walk Test Comparing Helium/Oxygen to Nitrogen/Oxygen for COPD Rehabilitation
Official title: Single Centre, Exploratory, Phase II, Cross-over, Randomised Trial, Evaluating the Effect of Spontaneously Breathing He/O2 65%/35% to Either Spontaneously Breathing N2/O2 65%35% or Non-Invasive Ventilated N2/O2 65%/35% on a 6 Minute Walk Test in Severe COPD Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Six-Minute Walk Test
Lead sponsor: Air Liquide SA
Sponsor class: INDUSTRY
Collaborators: name: Asklepios Kliniken Hamburg GmbH
First posted: 2011-05-18
Enrollment: 3
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate effects of inspired gas mixtures on the distance walked by patients with severe Chronic Obstructive Pulmonary Disease (COPD) during a Six-Minute Walk test.

Detailed description: the purpose of this study is to evaluate the distance walked by patients with severe Chronic Obstructive Pulmonary Disease (COPD) during a Six-Minute Walk test (6MWT) while breathing Helium/Oxygen 65%/35% compared to either breathing Nitrogen/Oxygen 65%/35% or receiving Non-Invasive Ventilation (NIV) with a FiO2 of 0.35 and to evaluate exercise related symptoms

Eligibility criteria: Inclusion Criteria:

* Male or female aged \>= 45 and \<= 75 years old
* Patient with documented clinical diagnosis of stage III/IV COPD
* Patient with stable COPD defined by no significant increase in COPD medication, no treatment for COPD in an emergency, no acute intensive care setting and no intake of antibiotics in the four weeks prior to selection

Exclusion Criteria:

* Inability or contra-indication to perform pulmonary function tests
* Inability or contra-indication to perform the 6MWT with a trolley
* Any contra-indication to receive NIV
* Obese patient having a Body Mass Index (BMI) \> 35
* Pregnant or lactating woman
* Female or chil-bearing potential with lack of efficient contraception

Primary outcomes:
measure: Distance walked
timeFrame: 6 minutes
Secondary outcomes:
measure: Assessment of the safety of inhalation Helium/Oxygen
timeFrame: 6 minutes
Other outcomes:
Locations:
city: Gauting
country: Germany
facility: Asklepios Fachkliniken München-Gauting
Study officials:
affiliation: Asklepios fachkliniken München-Gauting
name: Karl HAUSSINGER, Prof Dr Med
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00838409: USDA Behavior, Motivation & Nutrition Study
Official title: Examination of Metabolic Determinants of Behavior and Motivation in Obesity: Implication to the Development of New Strategies for Achieving Body Weight Health
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Body Weight
Lead sponsor: USDA, Western Human Nutrition Research Center
Sponsor class: FED
First posted: 2009-02-06
Enrollment: 40
Sex: FEMALE
Minimum age (years): 42
Maximum age (years): 52
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

Brief summary: This study will be a cross-sectional study. The primary aim of this study is to compare the relationship between neurological function, metabolic measures and health-related behaviors between normal weight and overweight/obese perimenopausal women.

Detailed description: To examine physiological and behavioral factors that may help determine health in perimenopausal middle age women. Neuroendocrine function will be measured by broad assessment of hypothalamic-pituitary-adrenal (HPA) activity. We will also assess metabolic profiles and behavioral and emotional function. We plan to determine correlations between these measures and nutritional state. Other measures may include insulin, glucose, leptin, IGF-1, triglycerides, free fatty acids, and ghrelin and eating attitudes and physical reactivity.

Eligibility criteria: Inclusion Criteria:

* Body Mass index 18-39.9 kg/m2
* Peri-menopausal status by self-report

Exclusion Criteria:

* Pregnant
* Plan to become pregnant
* Breastfeeding in the last 6 months
* Multiple sclerosis, amyotrophic lateral sclerosis, Parkinson's disease
* Menopause confirmed
* Unable to refrain from smoking for five hours (self-report)
* Unable to refrain from consuming alcohol for two days (self-report)
* Weight change \> 10 lbs in the preceding 6 months
* Chronic corticosteroid use
* Oral corticosteroids used more than twice in the last 12 months
* Hormonal contraceptives
* Antipsychotic, anti-anxiety and anti-depressant medications
* Beta adrenergic blockers
* Sibutramine, orlistat, phentermine, phendimetrazine, topiramate, zonisamide
* Immunosuppressants
* Amphetamines and other stimulants
* Severe food allergies or intolerances to foods
* Insulin Dependent Diabetes Mellitus

Primary outcomes:
measure: Correlation between metabolic measures and health-related behaviors in normal weight and overweight/obese perimenopausal women.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Davis
country: United States
facility: USDA, ARS, Western Human Nutrition Research Center
state: California
Study officials:
affiliation: USDA, ARS, Western Human Nutrition Research Center
name: Kevin Laugero, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06856109: 68Ga-Pentikra PET/CT Imaging Study in Healthy Subjects
Official title: 68Ga-Pentikra PET/CT Imaging Study in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2025-03-04
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief summary: This is a prospective, interventional clinical pilot study that recruited 10 normal volunteers who underwent 68Ga-Pentikra PET/CT imaging to evaluate the safety, biodistribution and radiation dosimetry of 68Ga-Pentikra in normal volunteers.


Eligibility criteria: Inclusion Criteria:

* 1) Age: 18 \~ 60 years old (including boundary values); 2) Gender: male or female; 3) Body weight: males weighing ≥50kg, females weighing ≥45kg, and body mass index \[BMI = weight (kg)/height 2 (m2)\] within the range of 19.0 \~ 26.0kg/m2 (including boundary values); (4) Subjects can fully understand and voluntarily participate in this experiment, and sign the informed consent form.

Exclusion Criteria:

- 1) Minors, pregnant women, lactating women, and those with severe hepatic or renal insufficiency (alanine aminotransferase exceeding the upper limit of normal values by 8-10 times and serum creatinine of 186-442 umol/L).

2) Previous history of tumour and surgery; 3) Other conditions judged by the investigator to be unsuitable as study subjects .

Primary outcomes:
measure: Maximum Standardized uptake value
timeFrame: 1 day from injection of the tracer
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Department of Nuclear Medicine,Xijing Hospital, Fourth Military Medical University, Xi'an, China, Xi'an, Shaanxi Province
state: Shaanxi
Study officials:
References:
Clinical trial NCT00145509: 40 Week Trial to Study the Safety of Asenapine When Added to Lithium or Valproate in the Treatment of Bipolar Disorder (A7501009)(P05786)
Official title: A Phase 3, Placebo-Controlled, Double-Blinded Continuation Trial Evaluating the Safety and Efficacy of Asenapine in Subjects Completing a 12-week Lead-in Trial and Continuing Lithium or Valproic Acid/Divalproex Sodium for the Treatment of an Acute Manic or Mixed Episode
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar Disorder
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2005-09-05
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this trial was to characterize the long-term (up to 40 weeks) safety and tolerability of asenapine in bipolar I disorder subjects who had not completely responded to continuing treatment with lithium or valproic acid (VPA) for the treatment of an acute manic or mixed episodes upon enrollment into the 12-week lead-in trial, A7501008 (NCT00145470). The safety comparison was between the group receiving lithium or VPA and placebo against the group receiving lithium or VPA and asenapine, with the caveat that all subjects may have received benzodiazepine and/or antidepressant rescue medication as needed.


Eligibility criteria: Inclusion Criteria:

* Have bipolar I disorder (current episode manic or mixed), be treated with lithium or valproic acid, and have completed the a 12-week lead-in trial

Exclusion Criteria:

* Have an unstable medical condition or clinically significant laboratory abnormality.
* Have a primary diagnosis other than bipolar I disorder.

Primary outcomes:
measure: Number of Participants Who Experienced an Adverse Event
timeFrame: up to 52 weeks
measure: Number of Participants Who Discontinued Because of an Adverse Event
timeFrame: 40 weeks
measure: Change From Baseline to Week 52 on the Young-Mania Rating Scale (Y-MRS) Score
timeFrame: Baseline and 52 Weeks
measure: Change From Baseline to Week 52 on the Montgomery Asberg Depression Rating Scale (MADRS) Score
timeFrame: Baseline and 52 Weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Szegedi A, Calabrese JR, Stet L, Mackle M, Zhao J, Panagides J; Apollo Study Group. Asenapine as adjunctive treatment for acute mania associated with bipolar disorder: results of a 12-week core study and 40-week extension. J Clin Psychopharmacol. 2012 Feb;32(1):46-55. doi: 10.1097/JCP.0b013e31823f872f.
Clinical trial NCT01835509: Group Intervention to Increase Physical Activity in Childhood Cancer Survivors
Official title: Group Intervention to Increase Physical Activity in Childhood Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Pediatric Cancer
Keywords: Childhood Cancer Survivors
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
First posted: 2013-04-19
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The primary aim of this randomized, controlled study is to evaluate the impact and feasibility of a prolonged physical activity intervention in school-aged childhood cancer survivors who self-report sedentary lifestyles. The study will test the hypothesis that childhood cancer survivors participating in a physical activity intervention guided by Social Cognitive Theory will increase the amount of time spent daily in moderate to vigorous physical activity, and improve exercise self-efficacy compared to children randomized to usual care. A secondary aim is to assess the impact of the intervention on cardiovascular risk factors including fitness and body composition.


Eligibility criteria: Inclusion Criteria:

1. Cancer survivors ages 8-12 years.
2. Off therapy for at least 3 months and not more than 5 years and in remission.
3. Medical clearance to participate in physical activities from the survivor's primary oncology provider;
4. Self-report of \< 60 minutes of moderate to vigorous physical activity (MVPA) per day.
5. Must be able to ambulate.
6. Signed informed consent/assent.

Exclusion Criteria:

None

Primary outcomes:
measure: Change in level of physical activity
timeFrame: change from pre-study and at 6months after camp
Secondary outcomes:
measure: Change in Self efficacy
timeFrame: Change in self efficacy measrued prestudy and 6 months after camp
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center
state: Maryland
Study officials:
References:
citation: Ruble K, Scarvalone S, Gallicchio L, Davis C, Wells D. Group Physical Activity Intervention for Childhood Cancer Survivors: A Pilot Study. J Phys Act Health. 2016 Mar;13(3):352-9. doi: 10.1123/jpah.2015-0050. Epub 2015 Aug 13.
Clinical trial NCT05420909: A Study of Overall Survival in Participants With Metastatic Colorectal Cancer (mCRC)
Official title: Overall Survival for Metastatic Colorectal Cancer Patients Matched to CHECKMATE-142
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Colorectal Cancer (mCRC)
Keywords: mCRC
Checkmate-142
Nivolumab
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-06-15
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who were diagnosed with mCRC and received 2L therapy of interest were selected from Flatiron Health's data from January 2013 through March 2019.

2L therapies of interest included:

* FOLFIRI and bevacizumab
* FOLFOX and bevacizumab
* CAPEOX and bevacizumab
* FOLFIRI and panitumumab
* FOLFIRI and ziv-aflibercept
* FOLFOX, bevacizumab and other (non I-O)
* FOLFIRI, ziv-aflibercept and other (non I-O)
* FOLFIRI, bevacizumab and other (non I-O)
* Nivolumab monotherapy
* Pembrolizumab monotherapy

Brief summary: The purpose of this study is to estimate the overall survival (OS) for US participants diagnosed with metastatic colorectal cancer (mCRC) by using Flatiron Health's individual patient level data.


Eligibility criteria: Inclusion Criteria:

* Metastatic Colorectal Cancer (CRC) participants in the Flatiron database as defined by:
* Diagnosed with CRC (ICD-9 153.x or 154.x or ICD-10 C18x, or C19x, or C20x, or C21x)
* Pathology consistent with CRC
* At least two documented clinical visits on or after January 1, 2013
* Evidence of Stage IV or recurrent metastatic CRC diagnosed on or after January 1, 2013
* Participants with high levels of microsatellite instability (MSI-H) and/or mismatch repair (MMR) protein deficiency (dMMR)
* Participants who received 2L therapy of interest on or after the initial mCRC diagnosis date
* Participants who had at least 1 month medical data during the prior to and post periods; however, participants who died within 1 month after the index date will not be excluded from the study

Exclusion Criteria:

* Participants \<18 years of age at index date
* Participants who received clinical trial drug during the prior or post periods

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to 6 years
measure: Duration of Systemic Treatment
timeFrame: Up to 6 years
Secondary outcomes:
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Local Institution
state: New Jersey
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT06368609: Preliminary Evaluation of Two Rapid Diagnostic Test Prototypes for Strongyloides Stercoralis Infection
Official title: Preliminary Evaluation of Two Rapid Diagnostic Test Prototypes for Strongyloides Stercoralis Infection
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Strongyloides Stercoralis Infection
Lead sponsor: IRCCS Sacro Cuore Don Calabria di Negrar
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Single center, no profit experimental study on sera available in the Tropica Biobank.


Eligibility criteria: Inclusion Criteria:

* Serum from immigrants from S. stercoralis endemic countries (i.e. individuals from Africa, Latin America, South-East Asia and western Pacific regions);
* Serum with a matched result of APC and/or PCR for S. stercoralis (i.e. the latter test/s done in the same day or ±30 days from the collection of the serum) and of serology assays (IFAT and/or ELISA) in use in our laboratory.

Exclusion Criteria:

* Unavailable/insufficient quantity of serum
* Serum from individuals who received treatment with ivermectin in the previous 6 months.

Primary outcomes:
measure: RDTs IgG results: positive or negative
timeFrame: baseline
measure: RDTs IgG4 results: positive or negative
timeFrame: baseline
Secondary outcomes:
measure: Agreement between readers
timeFrame: baseline
Other outcomes:
Locations:
city: Negrar
country: Italy
facility: IRCCS Sacro Cuore Don Calabria hospital
state: Verona
Study officials:
References: