louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT07018193: The Study of Personalized Health Check-up Programs and Standards for High-altitude Migrant Populations
Official title: The Study of Personalized Health Check-up Programs and Standards for High-altitude Migrant Populations
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: High Altitude
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2025-06-12
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Recruit those who live in plains and prepare to move to the plateau in the short term or medium term.

Brief summary: By using wearable devices to monitor and record the physiological data changes and health outcomes (incidence and severity of high-altitude illnesses) of high-altitude migrants at different stages (pre-entry, acute/chronic high-altitude phases, and de-acclimatization phase), and referencing previous cohort studies on high-altitude populations, the study aims to provide a basis for developing personalized health assessment protocols for high-altitude migrants. The formulated assessment protocols and standards will then be validated.


Eligibility criteria: Inclusion Criteria:

* Men and women aged ≥18;
* Those living in plains and preparing to move to the plateau for a short-term or medium-term period;
* Can understand the research requirements and be willing to sign a written informed consent form (ICF).

Exclusion Criteria:

* Past history of contraindicated plateau travel: such as advanced COPD (FEV₁\<30% of the expected value or requires continuous oxygen therapy), advanced cystic fibrosis (FEV₁\<30% of the expected value or requires continuous oxygen therapy), advanced restricted pulmonary disease (FEV₁\<50% of the expected value or requires continuous oxygen therapy), decompensated heart failure, high-risk pregnancy, myocardial infarction or stroke occurred within 90 days, poorly controlled epilepsy, pulmonary hypertension (PASP\>90mmHg), sickle cell anemia, unstable angina pectoris, high-risk cerebrovascular abnormalities that have not been treated, etc.

Primary outcomes:
measure: Rates of high altitude sickness and related diseases.
timeFrame: through study completion, an average of 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00238693: Transplant Patient Registry of Liver, Kidney and/or Pancreas
Official title: Transplant Registry: Patients Who May Require Transplantation and Those Who Have Undergone Transplantation of Liver, Kidney and/or Pancreas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: End Stage Renal Disease
End Stage Liver Disease
Keywords: transplant
transplantation of liver, kidney, pancreas
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2005-10-13
Enrollment: 13767
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients followed in the transplant clinic at Virginia Commonwealth University Health System

Brief summary: This is a registry of data collected from patient records, both of those who have a condition which may require transplantation and those who have undergone transplantation of the liver, kidney and/or pancreas.

Detailed description: Honest Broker arrangement.

Eligibility criteria: Inclusion Criteria:

* Patients followed in the transplant clinic at Virginia Commonwealth University Health System

Primary outcomes:
measure: Data collection and maintenance
timeFrame: Ongoing
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University Health System
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University Health System
name: Adrian H Cotterell, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03011593: Effect of UGIR in Adults With Compromised Gut Function and Malabsorption
Official title: Effect of UGIR on Quality of Life in Adults With Compromised Gut Function and Malabsorption
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Crohn Disease
Ulcerative Colitis
Celiac Disease
Lead sponsor: Metagenics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National University of Natural Medicine
First posted: 2017-01-05
Enrollment: 18
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study assessed the effect of a nutrition support product on quality of life in adults with compromised gut function and malabsorption.

Detailed description: This prospective, non-randomized, open-label study assessed the effect of a nutrition support product on quality of life in adults with compromised gut function and malabsorption. Adults with irritable bowel syndrome (IBS), inflammatory bowel disease (IBD) or celiac disease were enrolled in the study and asked to take the study product for 6 weeks. The primary measure of the study was a validated quality of life questionnaire, the Gastrointestinal Quality of Life Index (GIQLI). Secondary measures included the Inflammatory Bowel Disease Questionnaire (IBDQ), the Celiac Disease Questionnaire (CDQ), and the Digestive Symptom Frequency Questionnaire (DSFQ).

Eligibility criteria: Inclusion Criteria:

* Body mass index 19 - 40 kg/m2
* Previous diagnosis of ulcerative colitis (UC), Crohn's disease, irritable bowel syndrome (IBS), or celiac disease

Exclusion Criteria:

* Gastroenterologic surgery within 3 months before the study period
* Have a colostomy or ileostomy bag
* Malignancy within the last 5 years
* Women who are lactating, pregnant or planning pregnancy during the study period
* Taking antibiotic, antiparasitic, or antifungal medications
* Initiation of or changes to supplements or medications within 28 days prior to screening

Primary outcomes:
measure: Change in Gastrointestinal Quality of Life Index (GIQLI) Score
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Score
timeFrame: 6 weeks
measure: Change in Celiac Disease Questionnaire (CDQ) Score
timeFrame: 6 weeks
measure: Change in Digestive Symptom Frequency Questionnaire (DSFQ) Score
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Metagenics, Inc.
name: Nikhat Contractor, PhD
role: STUDY_DIRECTOR
References:
citation: Ryan JJ, Monteagudo-Mera A, Contractor N, Gibson GR. Impact of 2'-Fucosyllactose on Gut Microbiota Composition in Adults with Chronic Gastrointestinal Conditions: Batch Culture Fermentation Model and Pilot Clinical Trial Findings. Nutrients. 2021 Mar 14;13(3):938. doi: 10.3390/nu13030938.
Clinical trial NCT00497393: Clinical Decision Unit (CDU) - Evaluation of a Novel Approach to Address Emergency Department Overcrowding
Official title: Clinical Decision Unit (CDU) - Evaluation of a Novel Approach to Address Emergency Department Overcrowding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Illness
Keywords: Emergency department, administration, overcrowding
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Capital Health, Canada
First posted: 2007-07-06
Enrollment: 6217
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This randomized controlled trial will introduce a Clinical Decision Unit (CDU) into the University of Alberta Hospital Emergency Department(ED)and assess the influence on ED length of stay, patients who leave without being seen, and other ED Overcrowding outcomes.

Detailed description: The study will take place over a 6-week period that will be spilt into three-two-week blocks. Using computerized blocks of 2 weeks, days of the week will be randomly allocated so that each day of the week receives one intervention (CDU) and one control day for the study period. The CDU involves transforming an ED bed location to a 6-chair internal waiting room with 2 adjacent beds assigned to act as assessment and treatment locations. Patients will transition between the chair and stretcher to optimize the use of ED space.

Eligibility criteria: Inclusion Criteria:

* Only adult patients (\>17 years of age) presenting to the University of Alberta Hospital Emergency Department (UAH ED), during the study interval will be included in the evaluation.

Exclusion Criteria:

* Direct admits/Pediatric patients.

Primary outcomes:
measure: Total ED length of stay
timeFrame: in the Emergency Department
Secondary outcomes:
measure: Left without being seen (LWBS) rates
timeFrame: in the Emergency Department
measure: nurse and physician satisfaction
timeFrame: following Emergency Department shift
measure: ambulance turnaround times (time
timeFrame: in the Emergency Department
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
Study officials:
affiliation: University of Alberta Hospital, Edmonton, Alberta, T6G 2B7, Canada
name: Michael Bullard, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00490893: Hypoglycemia Counterregulation and Symptom Perception With Insulin Detemir
Official title: Effects of Insulin Detemir Versus Regular Insulin (Actrapid) on Hormonal Counterregulation, Cognitive Function and Symptom Perception During Hypoglycemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Diabetes Mellitus
Hypoglycemia
Keywords: counterregulation
hypoglycemia unawareness
insulin therapy
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2007-06-25
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Hypoglycemia and unawareness of hypoglycemia are major problems of insulin therapy in patients with diabetes mellitus. The long acting insulin analogue Detemir has structural and physicochemical properties which differ from human insulin. The aim of the present study is to test whether this leads to altered hormone and symptom response during hypoglycemia.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects male or female
* Age 18-50 years
* Female subjects save contraception
* Ability to take part in the study
* Signed consent

Exclusion Criteria:

* Chronic disease
* Acute disease during 4 weeks prior to the study
* Pregnancy
* Drug treatment other than hormonal contraception

Primary outcomes:
measure: Hormone response to hypoglycemia (Glucagon)
measure: Hormone response to hypoglycemia (glucagon) Symptom response to hypoglycemia
Secondary outcomes:
measure: Hormone response to glucagon (epinephrine, growth hormne, cortisol)
measure: Hormone response (epinephrine, growth hormone, cortisol) to hypoglycemia
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University of Tübingen, Medical Department
Study officials:
affiliation: University Hospital Tuebingen
name: Andreas Fritsche, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04996693: On Dose Efficiency of Modern CT-scanners in Chest Scans
Official title: On Dose Efficiency of Modern CT-scanners in Chest Scans- a Prospective, Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia
Lung Cancer
Pulmonary Embolism
Pulmonary Disease
Aortic Stenosis
Keywords: Spectral CT
Computed Tomography
Dose efficiency
Lead sponsor: University Hospital Augsburg
Sponsor class: OTHER
First posted: 2021-08-09
Enrollment: 958
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization of patients referred for a CT scan of the thorax on one of three CT scanners routinely used for this purpose in our department
Primary purpose: DIAGNOSTIC

Brief summary: CT scans of the chest / thorax are of great importance both in the initial diagnosis and in the follow-up of pulmonary or thoracic diseases. As an example, CT angiography of the pulmonary arteries (CTPA) is worldwide considered to be gold standard test in patients with a suspicion for pulmonary embolism.

The aim of this study is to measure and compare dose efficiency of modern CT scanners for unenhanced and contrast-enhanced scan protocols of the chest/thorax. Patients who are referred for a CT of the chest/thorax will be randomly assigned to one of the three CT scanners currently in use at our institution.


Eligibility criteria: Inclusion Criteria:

* patient is referred for an unenhanced CT OR contrast-enhanced CT of the chest/thorax confirmed by a board-certified radiologist ('justifying indication' according to German/European radiation protection law) AND
* patient is at least 18 years of age AND
* patient (is able to give informed consent and) has given informed consent.

Exclusion Criteria:

* high degree of medical urgency (i.e. patient cannot be consented for iv contrast according to routine procedures)
* known or suspected pregnancy, or lactating . contraindications for contrast agent (renal failure, allergy, hyperthyroidism)

Primary outcomes:
measure: Parameters of Objective Image Quality
timeFrame: 1 year
measure: Parameters of Radiation Dose
timeFrame: 1 year
Secondary outcomes:
measure: Subjective Image Quality Evaluation (entire cohort and for individual disease groups)
timeFrame: 1 year
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: University Hospital Augsburg
state: Bavaria
Study officials:
affiliation: Universitaetsklinikum Augsburg
name: Florian Schwarz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05153993: Effect of Stretching on Visco-elastic Behaviour of the Fascia Plantaris in a Healthy Population
Official title: Effect of Stretching on Visco-elastic Behaviour of the Fascia Plantaris in a Healthy Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fasciitis, Plantar
Stretch
Rehabilitation
Stiffness of Unspecified Foot, Not Elsewhere Classified
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2021-12-10
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: RCT with two arms: (1) stretch fascia plantaris (6 weeks, n=30) (2) control (n=30); Outcome parameters: ROM ankle and first toe; visco-elastic behaviour of the fascia plantaris determined by means of myotonometry Study protocol: Outcome parameters were evaluated before and after the intervention/control with a 6 weeks interval. All participants were screened bilaterally and for the participants assigned to the intervention group stretching was only performed on the dominant side


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Lower extremity injury

Primary outcomes:
measure: Visco-elastic behaviour using myotonometry
timeFrame: within 20 minutes before and after intervention
Secondary outcomes:
measure: Range of Motion of ankle joint and first metatarsalphalangeal joint
timeFrame: within 20 minutes before and after intervention
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Roel De Ridder
state: East Flanders
Study officials:
affiliation: University Ghent
name: Roel De Ridder
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05367193: 3D Visualization System for Vitreoretinal Diseases in Highly Myopic Eyes
Official title: Surgical Outcomes and Intraoperative Parameters Evaluation of 3D Visualization System for Vitreoretinal Diseases in Highly Myopic Eyes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients With Highly Myopic Eyes
Keywords: vitreoretinal surgery
high myopia
Pars plana vitrectomy
3D visualization system
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2022-05-10
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the surgical outcomes and intraoperative parameters evaluation of 3D visualization system for vitreoretinal diseases in highly myopic eyes

Detailed description: The investigators aimed to compare the safety and efficacy of NGENUITY® 3D Visualization System (Alcon, TX, USA) in vitreoretinal surgery of highly myopic patients with standard binocular microscope pars plana vitrectomy of highly myopic patients. This is a randomized controlled study and will enroll highly myopic patients who had axial length more than 26 mm and needed vitreoretinal surgery. The enrolled patients will be randomized into "NGENUITY® 3D Visualization System (Alcon, TX, USA) group"(trial group) and "standard binocular microscope pars plana vitrectomy group"(controlled group). The investigators will compare the number of injections of dye (indocyanine green (ICG) or brilliant blue G (BBG)), total surgical time, total peeling time, exposure time of dye, power of endoilluminator, the rate of probe bending, surgical time, postoperative intraocular pressure (IOP), the rate of wound leakage, hypotony, subconjunctival hemorrhage, vitreous hemorrhage, retinal hemorrhage, and endophthalmitis, best-corrected visual acuity (BCVA), structural changes shown on OCT and so on between the two groups.

Eligibility criteria: Inclusion criteria:

1. Highly myopic patients (axial length ≥ 26mm, no upper limit)
2. Patient with vitreoretinal pathology that require vitrectomy who had not received previous ICG or BBG-assisted membrane peeling
3. Patient aged ≥ 20 years

Exclusion criteria:

1. Patient who had previous ICG or BBG-assisted membrane peeling
2. Patient who received combined vitrectomy and trabeculectomy
3. Patient with endophthalmitis or intraocular foreign body

Primary outcomes:
measure: Number of injections of ICG
timeFrame: operation day
Secondary outcomes:
measure: Total surgical time
timeFrame: Intraoperative
measure: ILM peeling time
timeFrame: operation day
measure: ICG exposure time
timeFrame: operation day
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Ho Tzyy-Chang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06394193: Va Meh Du Intervention
Official title: Va Meh Du: An Intervention to Promote Mental Wellness Among Karenni Young Adults and Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Wellness
Keywords: physical activity
Karenni
community support
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2024-05-01
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The 20 anticipated coach participants, 10 will be assigned to the intervention and 10 will be assigned to the comparison group; assignment will occur based on availability.
Primary purpose: OTHER

Brief summary: This study is a conceptually integrated community-based participatory research study that includes the design and evaluation of an intervention to promote mental wellness and physical activity for Karenni children and young adults.

Detailed description: This study is a non-randomized equivalent design of an implementation and evaluation of an intervention to promote mental health and wellness among Karenni young adults and children by engaging in evidence-based mental health practices, relationship-building and physical activity through the team sport of soccer.

Eligibility criteria: Inclusion Criteria:

* Self-identifies as Karenni
* Speaks English or Karenni
* Currently lives in Forsyth County
* Male gender
* Consents to participate

Exclusion Criteria:

* None

Primary outcomes:
measure: Psychological well-being
timeFrame: Month 6
Secondary outcomes:
measure: Coach retention rate
timeFrame: Month 6
measure: Player retention rate
timeFrame: Month 6
measure: Coach completion rate
timeFrame: Month 6
measure: Player completion rate
timeFrame: Month 6
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Stephanie Daniel, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina
name: Ana Sucaldito, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02256293: Acceptability and Feasibility of an ACT-Based Group to Improve Diabetes Self-Management
Official title: Acceptability and Feasibility of an ACT-Based Group to Improve Diabetes Self-Management
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Type 1 Diabetes Mellitus
Keywords: Type 1 Diabetes
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2014-10-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Individuals with diabetes often report that difficult thoughts and feelings about diabetes interfere with making healthy choices with regards to diabetes management. The purpose of this study is to evaluate a diabetes self-management group based on Acceptance and Commitment Therapy (ACT). ACT is a new behavior therapy that has been found to be useful in treating psychological and behavioral difficulties. We are interested in whether individuals with diabetes will like an ACT-based diabetes management group and whether they find the group helpful.

Detailed description: The goal of the current study is to assess the acceptability and feasibility of an acceptance-based group to improve diabetes self-management among individuals with Type 1 Diabetes. Interested individuals will participate in a weekly acceptance-based therapy group focusing on improving diabetes management (e.g., adherence to dietary recommendations, appropriate insulin dosing) for a total of 8 weeks. Participants will also be asked to complete questionnaires both pre and post treatment. Questionnaires will assess diabetes management and acceptability of the group (post treatment only). Regular medical monitoring is required for participation in the current study. Participants will be asked to provide consent to contact their current medical provider in order to confirm that the participant's is receiving regular medical monitoring for diabetes care and that providers are aware of their patient's participation in group.

Eligibility criteria: Inclusion Criteria:

* Age 18-65
* Diagnosed with type 1 diabetes
* Currently monitored by a physician for their diabetes

Exclusion Criteria:

* Current or history of psychosis or mania
* Current substance abuse
* Non-English Speaking
* Deficits in intellectual functioning that preclude informed consent

Primary outcomes:
measure: Acceptability
timeFrame: 8 weeks
Secondary outcomes:
measure: Diabetes self-management
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Duke University
name: Rhonda Merwin, PhD
role: PRINCIPAL_INVESTIGATOR
References: