cyrilzakka/clinical-trials huggingface dataset:
Sunbit UV Measuring Device to Track Sun Behavior

Sunbit is a new wearable UV dosimeter to measure solar radiation in real time. The purpose of this study is to track sun behavior of patients at high risk for skin cancer, to investigate the feasibility of this prototype in daily life and to investigate the technical accuracy of the Sunbit.

A total of 20 patients will be included to wear the Sunbit system during the time of 4 weeks. After this 4 weeks Sunbit will be recollected and data in the form of UV Indices will be extracted and analyzed.

Patients will be recruited in the Department of Dermatology of the University Hospital Zürich. The target population comprises patients with a high risk of melanoma and non-melanoma skin cancer, thus especially patients with an immunosuppressive therapy due to organ transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* History of skin cancer (melanoma or NMSC) or patients with high risk of skin cancer (e.g. immunosuppressive therapy)
* Oral and written informed consent

Exclusion Criteria:

* Any medical condition that renders the patient bedridden for the duration of 2 weeks
Clinical Study of the Sonablate® 500 to Treat Localized (T1c/T2a) Prostate Cancer

This study will compare high intensity focused ultrasound to standard brachytherapy in the treatment of primary, organ confined prostate cancer.

The proposed study is a prospective, non-randomized concurrently controlled study. The active treatment arm uses the HIFU procedure with the Sonablate device. The control arm uses the brachytherapy procedure. The safety and effectiveness of the Sonablate arm will be compared with the brachytherapy arm. The control arm of the study will be conducted at clinical sites different from the Sonablate arm.

Eligibility Criteria:
Inclusion Criteria:

* T1c or T2a carcinoma of the prostate confirmed by biopsy;
* life expectancy of 5(five) years or more;
* prostate biopsy with 10(ten) or more core biopsies;
* Gleason score of 6(six) or less;
* serum Prostate Specific Antigen (PSA) of 10(ten)ng/ml or less;
* prostate volume of less than 40(Forty)cc;
* distance from the Anterior capsule surface to the Posterior capsule surface (AP Diameter) of 40(Forty)cm or less;
* informed consent for the treatment study through 24 months post-treatment follow-up

Exclusion Criteria:

* men who have had previous definitive treatment for prostate cancer;
* evidence of metastatic disease and/or a previous positive bone-scan, previous diagnosis or treatment for cancer within the last 5(five) years;
* prior hormonal therapy for prostate cancer (including bilateral orchiectomy);
* inability to tolerate a transrectal ultrasound;
* active urinary tract infection;
* functional bladder problems;
* prior significant rectal surgery;
* intra-prostatic calcifications greater than 1(One)cm in diameter;
* interest in future fertility;
* prostatic surgery/procedure (except biopsy) within 1(One) year;
* large median lobe of the prostate;
* use of medications that can affect PSA within 2(Two) months (e.g. finasteride, saw palmetto);
* current bladder cancer, urethral stricture, or bladder neck contracture;
* urinary tract and/or rectal fistula;
* rectal fibrosis/stenosis;
* anomaly of the rectal anatomy or mucus membrane;
* prostate seroma/abcess;
* prostatitis;
* compromised renal function or upper urinary tract disease secondary to urinary obstruction;
* bleeding disorders/coagulopathy based on measures of PT and PTT;
* implant in the prostate or within 1(One)cm of the prostate;
* zip code of the primary residence of the subject is greater than 200(Two hundred) miles from the clinical site or transportation that would hinder the completion of the study
Comparative Study of Conventional 1.5 and 3.0T MR Images With Synthetically Reconstructed MR Images

This study is being conducted for regulatory submission of the GE Healthcare MAGnetic resonance Image Compilation (MAGiC), a point-of-care synthetic MR reconstruction software for GE 1.5T and 3.0T MR scanners.

This study is a prospective, blinded, multi-center multi-reader (MCMR) clinical trial that is statistically powered for non-inferiority of diagnostic image quality of synthetic MR versus conventional MR and collection of supporting radiologic findings and morphology data from radiologists that reflect anticipated clinical usage of synthetic MR technology.

The study consists of three parts:

1. Clinical MR acquisition,
2. synthetic MR post-processing at a GE facility, and
3. blinded image evaluation (BIE) of conventional and synthetic images for each subject.

The study will enroll eligible adult subjects with clinical indications for brain MRI that meet applicable site MR safety criteria and are not pregnant. The study consists of one visit, the subject's MRI scan, without additional follow-up. Results are expected to be representative of expected clinical usage of synthetic MAGiC MR technology in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

Subjects must:

1. Be an adult 18 years of age or older;
2. Have clinical indication for MRI of the brain according to the site standard of care;
3. If female of childbearing potential (not surgically sterile or post-menopausal), be determined non-pregnant by a medically qualified investigator or demonstrated non-pregnant by negative urine pregnancy test;
4. Be able to hear and understand instructions without assistive devices;
5. Have necessary mental capacity to understand instructions be able to comply with protocol requirements;
6. Are able and willing to provide written informed consent by signing the informed consent form (ICF).

Exclusion Criteria:

Subjects will be excluded that:

1. Were previously enrolled in this evaluation;
2. Have metallic/conductive or electrically/magnetically active implants or attached medical devices (except for dental devices/fillings, surgical clips, and surgical staples) that could be unsafe for MRI;
3. Have contraindication(s) to MRI scanning per the routine MR Safety Screening policy of the investigational site;
4. Have severe trauma or pre-existing pathology that is expected to interfere with normal conduct of MR scanning or complete scanning of the brain;
5. Have medical condition(s) such as those requiring urgent medical care that, in the opinion of a physician Investigator, would prevent safe participation in the study.
Bone Loss in Patients With Anorexia Nervosa

Nutritional deprivation of adolescent girls with anorexia nervosa (AN) reduces the bone mass acquisition. A better understanding of this process would improve the medical treatment of bone alteration and its long-term consequences.

160 patients (age \< 38 yr) with AN and 160 age-matched controls (CON) will be enrolled in this study. The areal bone mineral density (aBMD) will be determined using dual-X-ray absorptiometry. Calciotropic hormones, bone turnover markers will be concomitantly evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent
* Health Insurance regimen or benefit from an health insurance regimen
* Aged from 14 to 38 years old
* Women
* No pregnant

Specific inclusion criteria for patient:

Patient suffering from anorexia nervosa defined by criteria of Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)

Specific inclusion criteria for controls:

* Normal menstrual cycles,
* No lifetime history of eating disorders,
* BMI between 18 and 25 kg/m²

Exclusion Criteria:

* use of treatments may be modify bone mass (bisphosphonates,...)
* Disease or treatment may be induce osteoporosis
* In exclusion period in relation with another study
* Law protected subject
Determining Metabolic Effects of Valproate and Antipsychotic Therapy

This study will determine the metabolic processes responsible for high levels of blood glucose, metabolism disorders, and weight gain in people with schizophrenia who have been treated with antipsychotic medications in combination with valproate.

This project aims to study the whole-body metabolic processes responsible for hyperglycemia, dyslipidemia and increased adiposity in schizophrenia patients treated with antipsychotic medications in combination with valproate. The project hypothesizes that combined treatment with valproate and antipsychotic medications will decrease insulin sensitivity at the level of skeletal muscle, liver and adipose tissue, in comparison to antipsychotic monotherapy. The decrease in insulin sensitivity is hypothesized to be associated with defects in glucose and lipid metabolism and increased adiposity

Treatment effects of antipsychotic/valproate combination therapy on different components of insulin secretion and action, and treatment effects on abdominal versus peripheral adiposity, are unknown despite the availability of gold-standard methods and the prognostic significance of these issues. Relevant data are needed to target basic research, to identify the potential for acute and long-term complications, and to plan therapeutic interventions. The following specific aims will be addressed in non-diabetic schizophrenia patients treated with atypical antipsychotics who will be randomized to open label treatment with either valproate or no adjuvant. Evaluations are performed at baseline and 3 months of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Meets DSM-IV criteria for schizophrenia, any type, treated with the same antipsychotic for at least 6 months
* No antipsychotic medication dose changes for 1 month, and no other medication changes for 1 month prior to study entry

Exclusion Criteria:

* Meets DSM-IV criteria for substance abuse within 3 months of study entry
* Involuntary legal status (as per Missouri law)
* Any serious medical disorder that may confound the assessment of relevant biologic measures or diagnosis, including: significant organ system dysfunction, metabolic diseases, type 1 or 2 diabetes mellitus, pregnancy, endocrine disease, coagulopathy, anemia, or acute infection
* Currently taking more than one antipsychotic medication
* Currently taking prescription medications (except certain psychotropic medications as discussed below), including oral contraceptive pills, any glucose lowering agent, lipid lowering agent, exogenous testosterone, recombinant human growth hormone, or any other endocrine agent that might confound substrate metabolism
Wideband Tympanometry for Monitoring Intracranial Pressure in Adult Patients in Intensive Care, Operated on for an Intracranial Lesion After Traumatic Brain Injury, or With Intracranial Hemorrhage

Intracranial pressure is usually measured by invasive methods requiring an intracranial sensor. There is no non-invasive monitoring method recognized as a gold standard. Tympanometry would make it feasible to evaluate intracranial pressure through sensitive and specific changes in the energy absorbance of the middle ear. It could represent a non-invasive method of monitoring intracranial pressure.

This is a prospective monocentric longitudinal study. All adult patients in intensive care for head trauma, intracranial hypertension, or after cranial surgery and requiring invasive monitoring of ICP will be included after their non-opposition has been collected.

In a group of 10 controls, multifrequency tympanometry will be performed in the standing position, in the 0° supine position and in the Tredelenburg position at -17°.


Eligibility Criteria:
Inclusion Criteria:

Patients:

* Person who did not oppose to their inclusion in the trial
* Head trauma, patient operated on for an intracranial lesion, or other condition (hemorrhagic stroke...) requiring monitoring of ICP by a subdural or epidural sensor.
* Age \> 18 years old

Controls:

* Person who did not oppose to their inclusion in the trial
* Age \> 18 years old
* No otologic or neurological history.

Exclusion Criteria:

* Person subject to a measure of legal protection (curatorship, guardianship)
* Person under judicial control
* Pregnant, parturient or breastfeeding woman
* Minor
* Fracture of the petrosal bone, abnormality of the bilateral middle or inner ear or canal preventing tympanometry
Exploratory Study of Dipraglurant (ADX48621) for the Treatment of Patients With Blepharospasm

This study is designed to assess the safety and tolerability of dipraglurant in patients with blepharospasm (BSP) (randomized 1:1:1 to receive dipraglurant 50 mg, 100 mg or placebo) and explore the efficacy of 50 mg and 100 mg immediate release tablets (versus placebo) on the severity and frequency of BSP signs and symptoms using objective measures, clinical ratings and patient reported outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Patients with an established diagnosis of idiopathic benign essential blepharospasm
* Must have had prior response to to botulinum toxin (BoNT) reported on last 2 consecutive injection cycles
* Last injection of BoNT at least 8 weeks prior to Screening assessments
* Patient is experiencing features of Blepharospasm (BSP) of moderate severity/frequency at study entry.

Exclusion Criteria:

* BSP that is known or suspected to be associated with a known cause such as neuroleptic exposure, brain injury or lesion, stroke, Parkinson's disease, or related Parkinsonisms
* History of surgical intervention (e.g., deep brain stimulation) or orbital myectomy for dystonia
* Disabling eyelid opening apraxia
* Other neurological disease (including psychiatric disease and/or cognitive impairment) that, in the opinion of the investigator, would affect the patient's ability to complete study assessments.
* Other significant medical condition that may affect the safety of the patient or preclude adequate participation in the study.

Other protocol-defined inclusion and exclusion criteria may apply
Using Technology to Optimize Collaborative Care Management of Depression in Urban and Rural Cancer Centers, SCOPE

This study compares the effectiveness of technology-enhanced collaborative care management (t-CoCM) to usual collaborative care management (u-CoCM) in achieving fidelity to processes of care and reducing depression symptoms in patients currently receiving cancer treatment. CoCM is a population-based, integrated care approach, where care managers, who are clinicians (typically clinical social workers), deliver behavioral treatments, coordinate psychosocial care, monitor outcomes, and adjust treatment with the input of a psychiatric consultant. The use of t-CoCM may improve the treatment of depression and improve patient outcomes and quality of life.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (t-CoCM): Patients use the t-CoCM digital app platform and clinic care managers use the t-CoCM web-based patient registry platform to support delivery of collaborative care. Patients complete surveys at baseline, 3, 6 and 9 months. Some patients also participate in an interview or focus group about their user experience with the t-CoCM digital platform. Care managers also participate in interviews or focus groups regarding their experience with CoCM and the newly developed web-based platform.

ARM II (u-CoCM): Patients receive usual care and clinic care managers deliver usual CoCM. Patients complete surveys at baseline, 3, 6 and 9 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving active treatment (surgery, chemotherapy, immunotherapy, targeted therapy, stem cell transplant, hormone therapy, radiation therapy) for a malignancy
* \>= 18 years old
* Participants must be ambulatory for clinical care visits
* Clinically significant depression (Patient Health Questionnaire-9 (PHQ-9) \>= 10 with at least one cardinal symptom \> 1)
* Access to smartphone, tablet, or computer with internet access; or landline

  * Patients who do not have a smartphone will be offered assistance in obtaining a free smartphone through the government-sponsored Lifeline Phone Program for low-resourced individuals

Exclusion Criteria:

* Advanced cancer or other condition that limits remaining life expectancy to less than 9 months
* Already engaged in or needing immediate specialty mental health care e.g., for bipolar disorder or schizophrenia
* Inability to speak and read English
Mechanism Based Resistance to Aspirin

The purpose of this research is to study why some people do not respond to the benefits of aspirin therapy. The benefit of aspirin is cardioprotection, or decreasing the risk of heart attack and/or stroke. Aspirin works by disabling the platelets, part of the blood cells used in clotting, from sticking together and forming blood clots, thus protecting the heart. It has been observed that failure to respond to aspirin therapy occurs in about 10% of the general population and that despite taking aspirin everyday, this group of non- responders is not getting protection for their heart. The investigators would like to determine why and how this happens.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 - 55
* Subjects must be in good health as based on medical history, physical examination, vital signs, and laboratory tests.
* All subjects must be non- smoking volunteers
* Female subjects of child bearing potential must be using a medically acceptable method of contraception (oral contraception, depo-provera injection, IUD, condom with spermicide, diaphragm, cervical cap, progestin implant, abstinence, tubal ligation, oophorectomy, TAH) throughout the entire study period. All female subjects must consent to a urine pregnancy test at screening and just prior to the start of each treatment phase of the study, which must be negative at all time points.
* Subjects must be within 30% of their ideal body weight.

Exclusion Criteria:

* Female subjects who are pregnant or nursing a child.
* Subjects, who have received an experimental drug, used an experimental medical device within 30 days prior to screening, or who gave a blood donation of ≥ one pint within 8 weeks prior to screening.
* Subjects with any coagulation, bleeding or blood disorders.
* Subjects who are sensitive or allergic to aspirin as well as any of their components.
* Subjects with documented history of any gastrointestinal disorders, including bleeding ulcers.
* Subjects with any evidence of cancer.
* Subjects with a history of heart disease, including myocardial infarction, angina, coronary artery disease, any evidence of coronary artery stenosis, arrhythmias, heart failure, having had a CABG
* Subjects with renal, hepatic, respiratory, endocrine, metabolic, hematopoietic or neurological disorder.
* Subjects with any abnormal laboratory value or physical finding that according to the investigator may interfere with interpretation of the study results, be indicative of an underlying disease state, or compromise the safety of a potential subject.
* Subjects who have had a history of drug or alcohol abuse within the last 6 months.
PET Imaging Study on Occupancy of Dopamine D2 Receptors and Genotypes After Bupropion Administration

Bupropion has different effects on D2 dopamine receptors according to genotype.

Open, one arm, single sequence, 2-period, study stratified into 2 DRD2 genotype groups For subjects who volunteer to cease smoking, genotypes are investigated. Twelve subjects are enrolled (6 - DRD2 Taq1A1 allele, 6 - DRD2 Taq1A2 homozygotes). Subjects receive baseline raclopride PET (High Specific Activity, Low Specific Activity).

* Period 1 Subjects receive 150 mg of bupropion SR every day. After 1 week of medication, pharmacokinetic and PET studies are performed.
* Period 2 Subjects receive 150 mg of bupropion SR twice a day. After 1 week of medication, pharmacokinetic and PET studies are performed.

Eligibility Criteria:
Inclusion Criteria:

* Active smoker (more than 10 cigarettes per day for the past 2 years)

Exclusion Criteria:

* Medical or psychiatric co-morbidity
* Hypersensitive to bupropion
A Study to Evaluate the Efficacy of Oral AKST4290 in Participants With Moderately Severe to Severe Diabetic Retinopathy (CAPRI)

A Double-Masked, Placebo-Controlled Study to Evaluate the Efficacy of Oral AKST4290 in Participants with Moderately Severe to Severe Diabetic Retinopathy (CAPRI).

This study is designed to evaluate the efficacy of AKST4290 administered at a total daily dose (TDD) of 800 mg daily (400 mg twice daily \[b.i.d.\]) compared with placebo over a 24-week dosing period in participants with moderately severe non-proliferative diabetic retinopathy (NPDR) to severe NPDR.

Participants will be enrolled and allocated to 1 of 2 treatment arms in a 2:1 randomization scheme (AKST4290: placebo). Participants will receive treatment for a total of 24 weeks with either AKST4290 800 mg daily (400 mg b.i.d.) in Arm 1 or placebo (matching tablets) in Arm 2

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years.
2. Type 1 or type 2 DM.
3. BCVA ETDRS visual acuity letter score≥ 69 letters at Screening.
4. Moderately severe NPDR (DRSS Level 47) to severe NPDR (DRSS Level 53).

Exclusion Criteria:

1. Evidence of neovascularization (NV) (including active iris or angle NV) requiring treatment, per investigator discretion.
2. PRP or grid laser within 1000 microns of the foveal center.
3. Center-InvolvedI-Diabetic Macular Edema (CI-DME) on clinical examination (CI is defined as DME within 1,000 microns of the foveal center).
4. Prior Intraocular of periocular steroid Injection
5. Systemic anti-VEGF or pro-VEGF treatment within 4 months prior to enrollment and assignment to a randomized treatment.
6. History of vitreoretinal surgery.
7. History of major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months or anticipated within the next 6 months following randomization.
8. History of DME or DR treatment with laser or intraocular injections of medication.
9. Medical history or condition that, in the opinion of the investigator would preclude participation in the study.
10. Clinically relevant abnormal laboratory value at Screening, including hematology, blood chemistry, or urinalysis (laboratory testing may be repeated once during the Screening phase).
11. Malignancy for which the participant has undergone resection, radiation, or chemotherapy within the past 5 years (treated basal cell carcinoma or fully cured squamous cell carcinoma are allowed).
12. Concurrent participation in another interventional clinical trial; prior clinical trial participants must have been off study agents for at least 30 days for small molecules, 4 months for disease modifying therapies, and 1 year for vaccine or immunotherapy trials prior to Screening.