louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01336790: International Lymphatic Disease and Lymphedema Registry
Official title: The International Lymphatic Disease and Lymphedema Patient Registry and Biorepository
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lymphedema
Keywords: Lymphatic disease
Lymphedema
Lymphangiomatosis
Lymphangiectasia
Protein-losing enteropathy
Vascular Anomalies
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Lymphatic Education & Research Network
First posted: 2011-04-18
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants (national and international participants) with the presence of lymphatic disease.

Brief summary: The purpose of the International Lymphatic Disease and Lymphedema Patient Registry and Biorepository is to collect health information in order to study the disease classification, natural history, and impact of Lymphatic Disease, Lymphedema and Related Disorders and its treatments and medical outcomes.

Detailed description: This project represents the inauguration of an International Patient Registry for Lymphatic Diseases. This project will be completed through an affiliation with the Lymphatic Education \& Research Network, a non-profit organization whose mission is to promote research and the development of new therapies for patients with lymphatic diseases, including lymphedema. The registry will provide researchers with much-needed clinical data to study the impact of diseases of the lymphatic system, in order to develop improved treatments and find a cure for lymphatic diseases, lymphedema, and related disorders. The establishment of this initiative is a major step forward in research for direct study of groups of patients with lymphatic disease. In the future, this project will be able to be linked with a biorepository, in which tissue and blood samples derived from patients will be made available for research into human disease states. An international patient registry and tissue/cell bank program paves the way for future clinical trials of experimental drugs and therapies designed to treat lymphatic disease in human subjects.

Eligibility criteria: Inclusion Criteria:

* Presence of lymphatic disease

Exclusion Criteria:

* None

Primary outcomes:
measure: prevalence of lymphatic disease
timeFrame: 15 years
Secondary outcomes:
measure: socioeconomic impact of lymphatic disease
timeFrame: 15 years
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Stanley G Rockson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03369990: DWP450 Treatment in Subjects With Benign Masseteric Hypertrophy
Official title: A Randomized, Double-blind, Placebo-controlled, Phase Ⅱ Optimal Dose-finding Study to Determine the Safety and Efficacy of DWP450 in Subjects With Benign Masseteric Hypertrophy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Benign Masseteric Hypertrophy
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2017-12-12
Enrollment: 98
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: This study is A Randomized, Double-blind, Placebo-controlled, Phase II Optimal Dose-finding Study to Determine the Safety and Efficacy of DWP450 in Subjects with Benign Masseteric Hypertrophy


Eligibility criteria: Inclusion Criteria:

1. Male or female subject over 18 years of age and written informed consent is obtained.
2. Subject with Benign Masseter Hypertrophy
3. Subject who has Bisymmetry of masseter at visual assessment.
4. Subjects who meets thickness of Masseter muscle by ultrasonography.
5. Subjects who can and will comply with the requirements of the protocol.

Exclusion Criteria:

1. Diagnosis of Myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function
2. Subject who got any treatment, including double jaw surgery, laser, thread treatment etc. in 12 months.
3. Subject who had previously received botulinum toxin within 3 months prior to the study entry
4. Subject with known hypersensitivity to botulinum toxin
5. Subject who are pregnant or lactating or found pregnancy though the urine or sebum test or disagreed to avoid pregnancy during study period.
6. Subjects who are not eligible for this study at the discretion of the investigator

Primary outcomes:
measure: Reduction amount of masseter muscle thickness
timeFrame: At 12 weeks
Secondary outcomes:
measure: Reduction amount of masseter muscle thickness
timeFrame: At 4,8,16 weeks
measure: Reduction amount of lower face volume
timeFrame: At 4, 8, 12, 16 weeks
measure: Overall satisfaction of subject
timeFrame: At 4, 8, 12, 16 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06348290: Study to Evaluate the Drug-drug Interaction of JMKX001899 in Healthy Subjects
Official title: a Single-center, Non-randomized, Open-label, Self-controlled Phase 1 Clinical Study to Evaluate Drug-drug Interactions of JMKX001899 Tablets in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Solid Tumor, Adult
Lead sponsor: Jemincare
Sponsor class: INDUSTRY
First posted: 2024-04-04
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an open-label, non-randomized, clinical study to evaluate the drug interaction between itraconazole, rifampin or Cocktail and JMKX001899 in healthy subjects. A total of three cohorts of 72 healthy subjects were planned to be enrolled in each cohort.


Eligibility criteria: Inclusion Criteria:

1. voluntarily sign the informed consent, fully understand the content of the trial, and be able to complete the study according to the requirements of the trial protocol.
2. subjects aged 18 to 45 years (including both ends) at the time of signing informed consent.
3. male body weight is not less than 50 kg, female body weight is not less than 50 kg, and body mass index (BMI) is within the range of 19 \~ 27 kg/m2 (including cut-off value).

Exclusion Criteria:

1. hepatitis B surface antigen HBsAg positive, hepatitis C virus antibody positive, positive AIDS antigen/antibody or Treponema pallidum antibody.
2. Patients with a history of clinically significant diseases including, but not limited to, gastrointestinal, renal, liver, neurological, hematological, endocrine, neoplastic, pulmonary, immune, psychiatric, or cardiovascular and cerebrovascular diseases, epilepsy, bipolar disorder/mania, intraocular hypertension, or acute angle-closure glaucoma.
3. have taken any products containing caffeine, alcohol, grapefruit, and xanthine-rich within 24 hours before taking study medication.

Primary outcomes:
measure: maximum concentrations (Cmax ) for plasma
timeFrame: approximately 3 days after first dose
measure: area under the curve from time 0 to infinity(AUC0-inf) for plasma
timeFrame: approximately 3 days after first dose
measure: area under the curve from time 0 to the last time point (AUC0-t) for plasma
timeFrame: approximately 3 days after first dose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04434690: Radiologic Results of One-Stage Bilateral TKR - One Surgeon Sequential vs. Two Surgeon Simultaneous: A Randomized Controlled Study
Official title: Radiologic Results of One-Stage Bilateral TKR - One Surgeon Sequential vs. Two Surgeon Simultaneous: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gonarthrosis; Primary
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2020-06-17
Enrollment: 80
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Many surgeons and patients prefer bilateral total knee arthroplasty (TKA) under one anesthesia as single-stage administration. A single-stage bilateral TKA can be performed in two different ways: single-stage, two-team simultaneous bilateral TKA (two surgeons bilateral TKA), and single-stage, a sequential bilateral TKA (single surgeon bilateral TKA). The purpose of this study is to evaluate the radiological results in the single-stage bilateral TKA in terms of two surgeons bilateral TKA and single surgeon bilateral TKA.

Detailed description: Investigators will enroll 136 participants with primary bilateral symptomatic knee osteoarthritis that will refractory to conservative treatment who will undergo bilateral TKA under single anaesthesia after 15.06.2020. Investigators will include patients who were less than 75 years old, with no history of malignancy, without severe extra-articular deformities, and without the systemic inflammatory disease, severe cardiac insufficiency, and morbid obesity (\>40 kg/m2 or 35 or more and experiencing obesity-related health conditions). An informed consent form will be obtained from all patients.

Eligibility criteria: Inclusion Criteria:

Primary bilateral knee osteoarthritis with refractory to conservative treatment Patients who accept participation in the research and the randomization

Exclusion Criteria:

no history of malignancy less than 75 years old without severe extra-articular deformities severe cardiac insufficiency and morbid obesity without systemic inflammatory diseases

Primary outcomes:
measure: Radiological examination
timeFrame: 14days
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
state: Fatih
Study officials:
References:
Clinical trial NCT05420090: The Effects of Milk and Banana as a Night Meal to Primary Insomnia on Sleep Quality, BDNF and Appetite Mechanism
Official title: The Effects of Milk and Banana Given as a Night Meal to Individuals Diagnosed With Sleep Disorders on Sleep Quality, BDNF and Appetite Mechanism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Insomnia
Keywords: diet
food
BDNF
Appetite
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2022-06-15
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. Experimental: Banana arm Experimental: Milk arm Control arm
Primary purpose: TREATMENT

Brief summary: The aim of this study to determine the impact of banana and milk on sleep and appetite

Detailed description: Sleep is one of the main components of the continuity of circadian rhythm. It restores energy and enhancement, memory. Sleep disturbances and short sleep duration are important risk factors for many diseases. Nutrition is one of the main determinants of health status in many diseases related to inflammation. Especially the night meal, known as the foods consumed before bedtime, has a strong effect on sleep. Although there are methodological differences, most studies show that unhealthy eating habits are associated with short sleep duration. It is thought that consuming foods with high tryptophan and melatonin content can reduce sleep problems. This study will give a chance to observe the effects of nutrients on sleep and appetite mechanisms.

Eligibility criteria: Inclusion Criteria:

* Applying to the Sleep Polyclinic,
* 18-45 years old,
* Body Mass Index (BMI) between 18.5-25 kg/m2,
* Male and female patients diagnosed with primary sleep disorder for the first time

Exclusion Criteria:

* Individuals with any psychiatric illness,
* Those who use cigarettes, alcohol, drugs or sedative drugs,
* Individuals with any chronic disease (diabetes, etc.),
* Pregnant and/or lactating
* Individuals with lactose intolerance,
* athletes,
* Individuals who are allergic to bananas
* Individuals with lactose intolerance or milk intolerance

Primary outcomes:
measure: Changing Score on the Pittsburgh Sleep Quality Index (PSQI) from baseline
timeFrame: at baseline, 6. week
measure: Level of Brain Derived Neurotrophic Factor (pg/ml)
timeFrame: at baseline, 6. week
measure: Level of Leptin (mg/dl)
timeFrame: at baseline, 6. week
measure: Level of Ghrelin (mg/dl)
timeFrame: at baseline and 6. week
measure: Evaluate stages of sleep and the oxygen level in blood
timeFrame: at baseline and 6. week
Secondary outcomes:
measure: Nutrient intake (g/day)
timeFrame: 6 consecutive weeks, 6 weeks
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University Medical Faculty
Study officials:
affiliation: KTO Karatay University
name: Muteber Gizem KESER, PhD,Lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03103490: 18F-FSPG PET/MRI or PET/CT Imaging of Cardiac Sarcoidosis or Inflammation
Official title: 18F-FSPG PET/MRI or PET/CT Imaging of Cardiac Sarcoidosis or Inflammation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cardiac Sarcoidosis
Myocardial Inflammation
Keywords: PET/MR
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: GE Healthcare
First posted: 2017-04-06
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The investigators will evaluate the detection of cardiac sarcoidosis or inflammation using 18F-FSPG PET/MRI (or PET/CT for participants with metal implants).

Detailed description: PET/MRI scans will be performed with a whole-body PET/MR imaging system capable of simultaneous PET and MR imaging (SIGNA, GE Healthcare, Milwaukee, WI). Approximately 45-60 minutes after IV injection of 8 mCi of 18F-FSPG, PET emission scanning and MRI acquisition T1 weighted scanning will begin imaging both whole body and the heart.

Eligibility criteria: Inclusion Criteria:

* Patient is ≥ 18 years old at the time of the scan
* Patient with known or suspected cardiac sarcoidosis.
* Patient is capable of complying with study procedures
* Patient can remain still for duration of imaging procedure

Exclusion Criteria:

* Patient is pregnant or nursing
* Metallic implants (contraindicated for MRI)
* History of renal insufficiency (only for MRI contrast administration)

Primary outcomes:
measure: Number of Participants With 18F-FSPG Uptake on PET/MRI or PET/CT Fused Images Indicating Cardiac Involvement of Sarcoidosis
timeFrame: average approximately 2 hours
Secondary outcomes:
measure: Number of Participants With Evidence of Whole Body 18F-FSPG Uptake on PET/MRI or PET/CT Fused Images Indicating Extra-cardiac Sarcoidosis
timeFrame: average approximately 2 hours
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Andrei Iagaru, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02358590: The Effect of Theory Menu-Based Intervention on Vitamin D Adherence in People With Osteoporosis-Pilot Study
Official title: The Effect of Health Action Process Approach Menu-Based Intervention on Vitamin D Adherence in Older Adult With Osteoporosis-Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2015-02-09
Enrollment: 32
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This pilot study evaluates the effect of theory menu-based mini-videos on vitamin D adherence in older adult with osteoporosis. Half of participants will watch the videos while the other half will receive usual care (treating physician advice).

Detailed description: Osteoporosis is a common disease around the world. The morbidity and mortality attributed to osteoporosis is due to fracture. The evidence shows that vitamin D is effective in preventing osteoporotic fracture, however, adherence to vitamin D is low among people with osteoporosis (20%-60%). The Health Action Process Approach (HAPA) has been found useful to describe, explain, and predict changes in health behaviours in a variety of setting. Based on HAPA, mini-videos will be developed aiming to increase vitamin D adherence in people with osteoporosis. Mini-videos will address self-efficacy, outcome expectancy, risk perception and action and coping plan. This pilot study aims to evaluate the recruitment and participants' feedback about the mini-videos.

Eligibility criteria: Inclusion Criteria:

* Over the age of 50 years
* Have been diagnosed with primary osteoporosis
* Have low vitamin D level (less than 75nmol/L) recently (within the previous month)
* Fluent in English

Exclusion Criteria:

* Cognitive diseases
* Mal-absorption syndromes that may interfere with vitamin D absorption.

Primary outcomes:
measure: Recruitment rate
timeFrame: 6 months
measure: Feedback of participants about the mini-videos
timeFrame: 5 minutes
Secondary outcomes:
measure: Serum level of vitamin D
timeFrame: after 3 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Osteoporosis Clininc affiliated to St. Joseph's Hospital
state: Ontario
Study officials:
affiliation: McMaster University
name: Norma J. MacIntyre, PT, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02017990: Plasma Marine n-3 Polyunsaturated Fatty Acids and Patient and Graft Survival
Official title: The Levels of Marine n-3 Polyunsaturated Fatty Acids in Plasma Phospholipids as a Prognostic Marker of Mortality and Graft Loss Endpoints in Renal Transplant Recipients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disorder of Transplanted Kidney
Keywords: Renal transplantation
n-3 polyunsaturated fatty acids
Mortality
Graft loss
Rejection
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: South-Eastern Norway Regional Health Authority
First posted: 2013-12-23
Enrollment: 2002
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Renal transplant recipients

Brief summary: This study will evaluate the association between n-3 polyunsaturated fatty acids and patient and graft survival. The association between other fatty acids and mortality and graft loss endpoints will also be evaluated.

Detailed description: This observational study focuses on the effects of marine n-3 polyunsaturated fatty acids (PUFAs) intake, measured as fatty acid levels in plasma phospholipids, and mortality and graft loss endpoints in renal transplant recipients. Data on morbidity, mortality and graft loss in The Norwegian Renal Registry is matched against data on fatty acid composition in a large renal transplantation cohort of approximately 2000 patients with a median follow up time of about 5 years. It is a follow up study, although retrospectively evaluated. It will evaluate the role of marine n-3 PUFAs as a prognostic marker in renal transplantation by investigating the association between the levels (weight percentage of total fatty acids) of marine n-3 PUFAs in plasma phospholipids and events, including mortality and graft loss.

Eligibility criteria: Inclusion Criteria:

* Received a renal transplant. Signed informed consent.

Exclusion Criteria:

* Under the age of 16 years.

Primary outcomes:
measure: All-cause mortality
timeFrame: Up to 12 years.
Secondary outcomes:
measure: Loss of function in the renal transplant.
timeFrame: Up to 12 years.
Other outcomes:
measure: Cause specific mortality rates.
timeFrame: Up to 12 years.
measure: Cause specific graft loss.
timeFrame: Up to 12 years.
measure: Rejection rate.
timeFrame: Up to 12 years.
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital, Rikshospitalet
state: * Oslo
Study officials:
affiliation: Oslo University Hospital
name: Ivar Eide, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eide IA, Jenssen T, Hartmann A, Diep LM, Dahle DO, Reisaeter AV, Bjerve KS, Christensen JH, Schmidt EB, Svensson M. The association between marine n-3 polyunsaturated fatty acid levels and survival after renal transplantation. Clin J Am Soc Nephrol. 2015 Jul 7;10(7):1246-56. doi: 10.2215/CJN.11931214. Epub 2015 Jun 10.
Clinical trial NCT00737490: Does Echocardiographically Guided Ventriculo-Ventricular Optimization Yield a Sustained Improvement in Echocardiographic Parameters in Cardiac Resynchronization Therapy Patients? (DEVISE CRT)
Official title: Does Echocardiographically Guided Ventriculo-Ventricular Optimization Yield a Sustained Improvement in Echocardiographic Parameters in Cardiac Resynchronization Therapy Patients? (DEVISE CRT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiomyopathy
Heart Failure
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Abbott Medical Devices
First posted: 2008-08-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine whether using an echocardiogram (a painless test where ultrasound is used to see your heart) while using mild electrical stimulation from your own CRT-D device to stimulate the ventricles (the lower chambers of the heart) to squeeze one slightly earlier than the other will show a sustained increase your heart's productivity (Cardiac Output (CO)), following implantation of a Cardiac Resynchronization Device (CRT-D). We believe that squeezing some parts of the heart earlier than others may make the heart a stronger pump.


Eligibility criteria: Inclusion Criteria:

1. LVEF \</= 35% as assessed by echocardiography.
2. New York Heart Association Functional Class III or IV CHF despite contemporary medical therapy for CHF.
3. QRS duration of \>/= 120 ms.
4. Ability to provide written, informed consent.
5. Age \> 18 years.
6. Successful implant of a biventricular/ICD pacemaker device.

Exclusion Criteria:

1. Documented Chronic Atrial Fibrillation
2. Life expectancy less that 6 months due to non-cardiac causes
3. Inability to place a coronary sinus left ventricular pacing lead
4. Pregnancy
5. Scheduled cardiac surgery within the next 6 months
6. Prosthetic Tricuspid Valve

Primary outcomes:
measure: To determine if a sustained hemodynamic benefit of increased Cardiac Output is maintained in patients who undergo ECHO guided optimization of V-V timing following CRT implantation when compared to patients simultaneously biventricularly paced.
timeFrame: 6 months
Secondary outcomes:
measure: Assessment for improvements in 1)6 minute walk 2)ECHO parameters 3)symptoms as assessed by the Minnesota Quality of Life Score.
timeFrame: 6 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Hranitzky Patrick, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Patrick Hranitzky, MD
role: STUDY_DIRECTOR
References: