cyrilzakka/clinical-trials huggingface dataset:
Brown Adipose Tissue Metabolism in Type 2 Diabetes

Activation of brown adipose tissue (BAT) by cold exposure.

BAT thermogenesis and BAT volume of metabolic activity will be assessed by Positron-Emitting-Tomography (PET/CT) and MRI/MRS imaging and new pharmacological methods to modulate BAT thermogenesis.

All previous data on the functioning of Brown Adipose Tissue (BAT) were obtained by Positron-Emitting-Tomography (PET) imaging studies using fluorodeoxyglucose F18 ( \[18F\]- FDG). This approach underestimates the actual activity of the BAT. In this study, the investigator is going to use a new PET tracer (C11-palmitate) which is a fat molecule. This will allow to quantify more accurately the activity of brown fat.

The study protocol includes three visits: the screening visit (V1) and two PET/MRI imaging studies (V2 and V3) performed in random order at an interval of 7 to 14 days.

PET/ MRI studies will be performed with and without nicotinic acid. A total of 500 mg of nicotinic acid will be given orally, at a rate of 2 doses of 150 mg and 2 doses of 100 mg, through V2 (protocol A): one dose at time 0, 60 minutes, 120 minutes and 180 minutes.

During V2 and V3, participants will undergo Acute Cold Exposure to stimulate brown adipose tissue.

The morning of each PET imaging study, the participants will follow an MRI acquisition to determine hepatic, pancreatic, visceral and BAT lipid content, followed by an MRS acquisition in the hepatic and cervico-thoracic region. MRI and MRS acquisition of the hepatic and cervico-thoracic region will be repeated again at the end of the day.

The radioactive PET tracers used in this study are the \[11C\]-acetate, \[11C\]-palmitate and \[18F\]-FDG followed by dynamic and whole-body scans.

Stable isotopes such as \[U-13C\]-palmitate (0.08 umol/kg/min), 5D-glycérol (0.1 µmol/kg/min,) and tritiated glucose (of 1.5 uCi/min) will be perfused from the start of the day until time 180 min.

Eligibility Criteria:
Inclusion Criteria:

* 10 men and 10 women with T2D.
* 10 non-diabetic men and 10 non-diabetic women (matched for sex, BMI and age to the T2D participants).

Exclusion Criteria:

* Change in weight of more than 2 kg over the past 3 months or recent changes in lifestyle;
* Treatment with a fibrate, thiazolidinedione, insulin, beta-blocker, GLP-1 agonist, or other drug known to affect lipid or carbohydrate metabolism, except statins, metformin, sulfonylurea, DPP-IV inhibitor and other antihypertensive agents that can be temporarily stopped safely prior to the studies, as per our approved protocols;
* Presence of overt cardiovascular, liver, renal or other medical conditions;
* Smoking or consumption of more than 2 alcoholic beverages per day;
* Any other contraindication to temporarily suspending current medications for lipids or hypertension;
* Any contraindication to MRI scanning.
* Having participated to a research study with exposure to radiation in the last two years before the start of the study.
Sequencing of 14 Genes From Leptin Melanocortin Pathway in Severe Obesity in Childhood.

About 380 million children and adolescents suffer from overweight and obesity at the global level. Obesity results from the interplay between biological (sex, age, fetal programming, gut microbiota, epigenetics, and genetics) and environmental factors (e.g., unhealthy diet, physical inactivity, stress). Mutations in genes from leptin melanocortin pathway are involved in "non syndromic monogenic obesity", characterized by severe early onset obesity, hyperphagia and endocrine deficiencies. Exact frequencies of mutation in these genes are not precisely evaluated in french children with severe obesity. Moreover new treatment, such seltmelanotide are avalaible in case of certain mutation, leading to a significative weight loss in treated patients.

Obesity is a global health concern that affected more than 650 million adult people and more than 380 million children and adolescents worldwide, with no signs of slowing down despite major investments in health policy. Obestiy is a multifactorial disease, but 40 to 75% of body mass index (BMI) variation is explained by genetic factors.

Mutations in genes from leptin melanocortin pathway lead to "non syndromic monogenic obesity", characterized by severe early onset obesity, hyperphagia and endocrine deficiencies. This pathway plays a central role in regulating mammalian food intake, energy expenditure and body weight regulation. Somes genes are well characterized such LEP gene, LEPR gene, or MC4R but others have been recently described as ADCY3, SIM1, SH2B1, NTRK2, BDNF, KSR2.

The frequency of these mutations are not precisely estimated in a group of french children with severe obesity.

Moreover, a precocious identification of these mutations, could afford, in certain case the possibility of a efficient treatment with setmelanotide, leading to a significant weight loss in treated patients.

Eligibility Criteria:
Inclusion Criteria:

* severe obesity with BMI \> 3SDS

Exclusion Criteria:

* genetic obesity (Prader Willi syndrome, Bardet Biedl syndrome, X fragile syndrome, Alstrom syndrome)
* BMI \< 3 SDS
* age \< 6 months
* monogenic non syndromic obesity, with mutation in genes of leptin melanocortin pathway previously diagnosed
* cushing syndrome
Drug Use Investigation (DUI) of YazFlex for Endometriosis-associated Pelvic Pain and/or Dysmenorrhea

This study is a Japanese post-marketing surveillance (PMS) which is required by the regulatory authorities. General objective of PMS is to confirm the clinical usefulness, especially the safety profile of a drug under the routine clinical practice.

It is a local, non-interventional, multi-center, single-cohort study using primary data of patients treated with YazFlex in endometriosis or dysmenorrhea indication.

A total of 600 patients (300 for endometriosis and 300 for dysmenorrhea) is planned to be enrolled in 2 years.

The treatment should be performed in Japan based on the product label. The patients will be observed for up to 2 years (1 year at the earliest) during their YazFlex treatment.

The outcome variables for the primary objective are treatment emergent adverse events (TEAEs) and adverse drug reactions (ADRs). The outcome variables for the secondary objective include newly developed haemorrhagic ovarian cyst, genital bleeding, severity of dysmenorrhea, pelvic pain and compliance status in the new flexible regimen.

Eligibility Criteria:
Inclusion Criteria:

* Patients with endometriosis-associated pelvic pain and/or dysmenorrhea.
* Patients for whom the decision to initiate treatment with YazFlex is made as per physician's clinical practice.

Exclusion Criteria:

- Patients participating in an investigational program with interventions outside of routine clinical practice.
The Effect of the Patient Activation Measure on Chronic Care

We will test - in a chronically ill managed long term care population - the effectiveness of an intervention that provides nurse Care Managers with an inventory of evidence-based practices tailored to patients with different levels of knowledge, skills and confidence to engage in self-care management. Specifically, we will develop a "change package" of evidence-based hypertension (HTN) management strategies geared to patients scoring at the four different stages of activation on the Patient Activation Measure (PAM). We will randomly assign a group of interdisciplinary teams in the managed long-term care plan to intervention or control status and will train the Care Managers on the Intervention teams to use the change package in conjunction with a patient's PAM score to design - with the involvement of the patient - an individualized HTN management plan. We then will assess the impact of the intervention on patient activation and outcomes.

The three main aims of the project are to:

1. Determine whether the PAM-driven intervention increases patients' knowledge and self-management skills, measured by both generic PAM scores and HTN-specific measures developed by the research team.
2. Determine whether the PAM-driven intervention improves HTN patients' systolic and diastolic blood pressure (BP), measured in three ways:

   * Average percent reduction in systolic and diastolic BP.
   * Percent of patients who achieve BP control (defined as \<140 systolic and \<90 diastolic BP or \<130 systolic and \<80 diastolic for patients with diabetes or renal disease).
   * Percent of patients with controlled HTN who maintain control.
3. Conduct an analysis to examine implementation of the intervention by trainers and Care Managers in the Intervention group and to understand the barriers and facilitators affecting the implementation process.

   In addition, we will conduct a feasibility study with a subset of Care Managers to determine how the Visual Scan Assessment of Patient Activation might be incorporated into routine assessment and care planning procedures. Therefore, the fourth aim of the project is to:
4. Assess the feasibility and perceived usefulness of the Visual Scan Assessment as a tool to increase feedback to Care Managers on how well they are supporting patient self-care management.

Eligibility Criteria:
Inclusion Criteria:

* active VNS CHOICE patient on one of the 22 Intervention or Control teams at the start of the intervention period,
* in care for less than or equal to 730 days,
* a formal diagnosis of HTN (using appropriate ICD codes recorded in the patient record), and
* English speaking.

Exclusion Criteria:

* moderate or severe cognitive impairment as measured by a six-item short portable mental status assessment
* organic brain disease dx in as one of the top 5 dx as measured by information in OASIS, the uniform home care assessment instrument mandated by the Centers for Medicare and Medicaid Services
* End Stage Renal disease dx as one of the top 5 dx as measured by information in OASIS
Catheter-interventional Treatment of Pulmonary Embolism

Recent evidence supports the use of catheter-interventional techniques for the treatment of intermediate-high-risk pulmonary embolism. While there is evidence supporting the use of catheter-thrombectomy and alternatively local fibrinolysis, less is known on the combination of both approaches.

The investigators aim to assess the effects of a combined interventional local fibrinolysis and catheter-thrombectomy and to compare them with conventional treatment in a cohort of patients with intermediate-high-risk pulmonary embolism.


Eligibility Criteria:
Inclusion Criteria:

* confirmed intermediate high-risk pulmonary embolism
* age \>= 18 years

Exclusion Criteria:

* high-risk pulmonary embolism
* contraindications for catheter-based treatment
* known allergy to anticoagulant treatment or fibrinolytics
* pregnancy
* participation in other randomized trials
* patients under legal supervision or guardianship
Proximal Priority Versus Distal Priority Robotic Priming Effects in Patients With Chronic Stroke

This is a single-blind randomized comparative efficacy study involving 54-72 participants with chronic stroke. Participants will be randomized into proximal priority robotic group or distal priority robotic group and receive 18 intervention sessions (90 min/d, 3 d/wk for 6 weeks). The Fugl-Meyer Assessment Upper Extremity subscale, Medical Research Council Scale, Revised Nottingham Sensory Assessment, and Wolf Motor Function Test will be administered at baseline, after treatment, and at the 3-month follow-up. Two-way repeated-measures analysis of variance and the Chi-Square Automatic Interaction Detector Method will be used to examine the comparative efficacy and predictors of outcome, respectively, after intervention.

Background. The sequence of establishing proximal stability or function before facilitation of the distal body part has long been recognized in stroke rehabilitation practice but lacks scientific evidence. This study plans to examine the effects of proximal priority robotic priming and impairment-oriented training (PRI) and distal priority robotic priming and impairment-oriented training (DRI).

Methods. This is a single-blind randomized comparative efficacy study involving 54-72 participants with chronic stroke. Participants will be randomized into PRI or DRI groups and receive 18 intervention sessions (90 min/d, 3 d/wk for 6 weeks). The Fugl-Meyer Assessment Upper Extremity subscale, Medical Research Council Scale, Revised Nottingham Sensory Assessment, and Wolf Motor Function Test will be administered at baseline, after treatment, and at the 3-month follow-up. Two-way repeated-measures analysis of variance and the Chi-Square Automatic Interaction Detector Method will be used to examine the comparative efficacy and predictors of outcome, respectively, after PRI and DRI.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria are age between 20 and 75 years old, more than 3 months after the onset of a first unilateral ischemic or hemorrhagic stroke, moderate to severe UE motor impairment (i.e., total UE score of the Fugl-Meyer Assessment \[FMA\] score between 18 and 56), no severe spasticity in any joints of the affected arm (modified Ashworth Scale score \<3 in any of the affected shoulder, elbow, wrist, and fingers), able to follow instructions (Mini-Mental State Examination total score \>24), no UE fractures in the past 3 months, and not simultaneously participating in other medication or rehabilitation studies.

Exclusion Criteria:

* The exclusion criteria are other neurologic, neuromuscular, or orthopedic disease, such as epilepsy, or severe health or physical conditions that might impede participation in this study.
Portable Monitoring for Diagnosis and Management of Sleep Apnea

This multi-site project compares compares the efficiency of a home-based portable monitoring strategy to a standard of care sleep laboratory-based strategy for the diagnosis and positive airway pressure treatment of obstructive sleep apnea in adults.

The study is a randomized, parallel group, unblinded, multicenter study that compares two approaches \[home-based, portable monitoring (PM) versus attended, laboratory-based polysomnography (PSG) (Lab)\] in adults, at least 18 years of age, with a moderate to high probability of obstructive sleep apnea (OSA) and who have been referred to sleep medicine specialists at AASM-accredited sleep centers for evaluation and/or management. The study is designed to compare the utility of the two approaches (PM group vs. Lab group) for the diagnosis and management of OSA in adults. Approximately 372 eligible adults will be randomized at screening to either the PM or Lab arm (186 per arm), undergo baseline OSA testing to confirm diagnosis and study eligibility, then receive positive airway pressure (PAP) titration studies to determine the level of pressure needed to treat their OSA. For qualifying participants, the titration study will be lab-based in the Lab group and be home-based using a commercially available portable, automatic PAP device (APAP) in the PM group. All qualifying study participants will have access to study CPAP equipment and supplies to treat their OSA. Primary outcomes (time from diagnosis to effective treatment, patient outcomes, and relative resource utilization) are determined at 1 and 3 months after starting CPAP treatment. Study participants who complete all of their study visits will keep their CPAP machine at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Intermediate to high probability of having OSA based on an adjusted neck circumference \> 43 cm (17 inches)
* Presence of excessive daytime sleepiness (Epworth sleepiness scale ≥ 12) Apnea-hypopnea index \>= 15 on diagnostic testing to continue in study

Exclusion Criteria:

* Severe chronic insomnia, other condition with \< 4 hrs of sleep per night
* Unstable medical conditions
* Major psychiatric diagnosis
* Unable to undergo home testing
* Concerns about unsafe driving
* Severe COPD or restrictive lung disease
* Chronic narcotic use
* Alcohol abuse
* History of cataplexy
* Moderate to severe restless legs syndrome symptoms
* Pre-existing diagnosis of sleep apnea
* Prior experience with positive airway pressure treatment of sleep apnea
* Anticipated upper airway surgery or gastric bypass surgery in 4 months
* Decisional impairment for consenting
* Hypoventilation syndrome, identified in the medical record
* Waking oxygen saturation \< 92%
Motion Correction in Dynamic Contrast Enhanced Magnetic Resonance Imaging (MRI) in Ovarian Cancer: A Pilot Study

The purpose of this study is to develop new image analysis method using Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI) for ovarian cancer. MRI is not currently part of the standard care for ovarian cancer. In this method, a contrast agent is used to make ovarian cancer visible during imaging.


Eligibility Criteria:
Inclusion Criteria:

* Patients with measurable disease with evidence of at least one uni-dimensionally measurable tumor (\> 1 cm) by CT or MRI scan according to RECIST (Response Evaluation Criteria in Solid Tumors) that the tumor has not been initially treated with surgery or radiation therapy.
* Patients who will start treatment with bevacizumab combined with or without cytotoxic chemotherapy within 14 days from signing consent. Patients treated on an approved IRB therapeutic protocol for recurrent ovarian cancer with bevacizumab are eligible.
* Patients with histologically confirmed ovarian epithelial cancer including primary peritoneal and fallopian tube adenocarcinoma.
* Patients of childbearing potential must have a negative serum pregnancy test prior to the study entry and be practicing an effective form of contraception.
* Patients who are older than 21 years of age.
* Patients who are able to understand and sign informed consent.

Exclusion Criteria:

* Patients treated on an approved IRB therapeutic protocol with a blinded arm of bevacizumab or placebo are not eligible (IRB 07-078 and IRB 05-138).
* Patients with cardiac pacemakers.
* Patients with certain prosthetic devices and implants who are not compatible with the high magnetic field present in the DCE-MRI scanners.
* Patients who have experienced a prior adverse reaction to the gadolinium complex contrast agent used in DCE-MRI imaging and who don't meet criteria for creatinine and nephrogenic systemic sclerosis risk per guidelines of department of radiology.
* Patients prone to claustrophobia.
* Patients on dialysis.
Donors With Nephrolithiasis at the Time of Transplant Evaluation (DONATE). Long Term Follow-up.

We believe that kidney donors with kidney stones accepted for a donation do not have an increased risk of loss of kidney function and will not be at increased risk of symptomatic kidney stone events compared to donors without a history of kidney stones.

Indiana University Health center has a large nephrology and transplant service which is well versed in taking care of kidney donors with history of kidney stones. We believe that kidney donors with kidney stones accepted for a donation do not have an increased risk of loss of kidney function and will not be at increased risk of symptomatic kidney stone events compared to donors without a history of kidney stones. In this study we are contacting past kidney donors and participants with kidney stone who were declined as kidney donors. We will use blood tests, 24-hour urine tests, computed tomography (CT) scan, patient reported medical history and medical history in the patient's chart to gather data. This data will help us compare non stone donors, stone donors, and participants with kidney stone who were declined as kidney donors.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18,
* Evaluation for kidney donation \> 2 years ago, with A) no history of kidney stones, or kidney stones on Imaging and successfully donated a kidney B) either had history of kidney stones or kidney stones on imaging and either i) successfully donated a kidney or ii) were declined for donation due to history of kidney stones, Litholink abnormalities or Imaging findings
* Willing to participate and sign an informed consent.

Exclusion Criteria:

* Subjects who are currently pregnant or breast feeding.
The Effectiveness of Reconstructive Microsurgery on the Clinical and Functional State of Laryngeal Stenosis

To improve diagnostic methods for patients with laryngeal stenosis for the optimal determination of the technique of surgical treatment.

The study include patients with laryngeal pathology in the otorhinolaryngology clinic of the 1-city hospital at Nur-Sultan city. All patients cheek up the necessary clinical, functional, diagnostic studies and treatment measures. It is planned to examine and operate on 70 patients with laryngeal pathology.

1. To study the features of the course of stenosis of the larynx under the influence of various factors, as well as traumatic injuries.
2. To develop optimal diagnostic methods for patients with laryngeal stenosis.
3. To assess the effectiveness of endolaryngeal microsurgery in patients with laryngeal stenosis.
4. To develop recommendations for the organization of treatment for stenosis of the larynx with an increase its functional state.

Eligibility Criteria:
Inclusion Criteria:

* medically diagnosed with stenosis of larynx
* patients who were observed larynx by MRI and CT
* patients who need surgical treatment of stenosis of larynx

Exclusion Criteria:

* pregnancy
* patients who has positive electromyography findings of motion of laryngeal muscles
* patients who has contraindications to surgical treatment on the other diseases
* patients who has not normal results of lab. analyses
C-STAR Movement Database

The purpose of this study is to develop a database that contains movement and rehabilitation-related data collected through the use of wearable sensors and video. This database will serve as a resource for clinicians and researchers interested in the investigation of movement or rehabilitation-related research ideas.

Scholarly research in the field of physical rehabilitation helps to aid in maximizing outcomes for individuals that require these services due to orthopedic and neurologic injuries. To produce quality research results, large cohorts of individuals are often required for data analysis. Some research facilities or labs do not have adequate access to large cohorts or may not have the means to recruit them. By building the C-STAR database, the intent is to create a database that can serve as a hub for data sets that researchers and clinicians with appropriate access may use to support their research questions related to movement and physical rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

1. Age 0 to 99 years old
2. Able and willing to give written consent and comply with study procedures

Exclusion Criteria:

1. Unable to give written consent or comply with study procedures
2. Any condition that would prevent safe completion of study activities, as determined by the Principal Investigator