cyrilzakka/clinical-trials huggingface dataset:
Does Vitamin D Reduce Risk of Developing Type II DM in High Risk Individuals

Both vitamin D deficiency and type II DM/prediabetes are highly prevalent. Vitamin D status has been negatively associated with the presence of type II DM and glycemic control. A cause-effect relationship between vitamin D deficiency and the development of type II DM has not been established.

The investigators plan to conduct a 2 year, double blind, randomized, placebo controlled trial on the effect of vitamin D3 supplement on the incidence of type II DM in high risk individuals.


Eligibility Criteria:
Inclusion Criteria:

* Adults living in Riyadh area with impaired fasting glucose or/and impaired glucose tolerance (prediabetics) and total 25 OH vitamin D level between 10-30 nmol/l
* Who consume no more than one serving of milk/day
* Do not take vitamin supplement
* Habitually have less than 10 hour of sun exposure per week
* Don't suffer from granulomatus conditions, liver disease, kidney disease, or diabetes
* Don't take anticonvulsants, barbiturates, steroids, or antidiabetic medications.
Effects of Hyperthyroidism on Amount and Activity of Brown Adipose Tissue

The investigators wish to evaluate the effect of thyroid hormones on brown adipose tissue in humans in an observational study on patients with thyrotoxicosis. In the investigators evaluation the investigators will use FDG-PET/CT, indirect calorimetry and fat biopsies in the acute phase of the disease and in the euthyroid phase after treatment.

It is the investigators hypothesis that high levels of circulating T3 might affect amount and function of brown adipose tissue.

10 patients with thyreotoxicosis (T3 \> 3 nmol/L and suppressed TSH) will be investigated at diagnosis and after 3-6 months of euthyroidism induced by antithyroid treatment. The patients will all be over the age of 50 due to the radiation given by the scans (requested by the local Ethical Committee). All will be scanned for active BAT by the integrated FDG PET-CT before and after treatment.BAT is activated by means of crushed ice placed under the feet in individualized intervals during the scan procedure. Indirect calorimetry is done to determine the basal metabolic rate and subcutaneous fat biopsy to examine the effect on subcutaneous white fat and the possible "browning" effect.

Eligibility Criteria:
Inclusion Criteria:

* men and women with hyperthyroidism (T3 \> 3 nmol/l)
* \> 50 years old
* women must be postmenopausal

Exclusion Criteria:

* thyrotoxic crises
* severe concurrent sickness that will make it unsafe to postpone treatment, this includes severe kidney disease (creatinin over 160)- and heart disease (NYHA group 3 and 4).
* diabetes
* former and current treatment with interleukin-2
* Patients who are already treated with β-blockers
* severe claustrophobia
* BMI \> 30 kg/m2
Sphingosine-1 Phosphate -Receptor Targeting and Microglial Activation

To evaluate the usability of positron emission tomography imaging as a novel outcome measure in multiple sclerosis studies

Background and Rationale

In multiple sclerosis (MS), significant pathology correlating to disease progression, to expanded disability status scale (EDSS) and to cognitive decline, takes place outside the plaque areas, i.e. in areas of normal appearing white matter and gray matter. Neuropathological studies suggest that mechanisms involved in this widespread pathology include activation of microglial cells, oxidative stress and deficiency in mitochondrial functions. Activated microglia can be detected in vivo with a translocator protein (TSPO), expressed in activated, but not resting microglia) binding radioligands and positron emission tomography (PET). 11Carbon-PK11195 radioligand is one such radioligand. Importantly, the possible effect of MS therapies on microglial activity can be evaluated in patients in vivo with PET-imaging performed before and after the treatment.

Eligibility Criteria:
Inclusion Criteria:

Having signed the informed consent of the investigator-initiated PET study

* Age 18 - 58 years at the time of informed consent.
* MS according to Poser or McDonald criteria
* EDSS score from 0.0 to 6.5.
* Moderate to heavy lesion load ( \>9 T2 lesions) in MRI

Exclusion Criteria:

* - Patients with other neurodegenerative disease than MS
* Disease modifying therapy (DMT) within 4 weeks of imaging
* Corticosteroid treatment within 4 weeks of imaging
* Patients with significant abnormal findings other than MS in the screening MRI.
* Patients with claustrophobia, or a history of moderate to severe anxiety disorder or panic attacks (which could potentially lead to preterm termination of the imaging)
* Contraindication to PET scan investigations
* Exposure to experimental radiation in the past 12 months such that radiodosimetry limits would be exceeded by participating in this study.
* Intolerance to previous PET scans; i.e. previous hypersensitivity reactions to any PET ligand or imaging agent or failure to participate in and comply with previous PET scans.
Nutraceuticals Versus Usual Care in the Prevention or Reduction of CIPN in Patients Treated With Docetaxel as Neoadjuvant/Adjuvant Breast Cancer Therapy

The trial will utilize Nutraceuticals (Vitamin D 2000IU oral once daily, Vitamin B6 100 mg oral once daily, Vitamin B12 100 mcg oral once daily, Omega-3 Fatty Acids 900 mg oral three times a day) in patients treated with Docetacel as Neoadjuvant or Adjuvant Breast cancer Therapy. The trial is being conducted to see if the use of Nutraceuticals will prevent or reduce Chemotherapy Induced Peripheral Neuropathy (CIPN).

Phase 2, Single Centre, Open-label 2 Arm Randomized Trial. The intervention group will receive a daily dose of Vitamin D, Omega-3-fatty acids, Vitamin B6, and Vitamin B12. The reference group will have usual care.

Dose of Nutraceuticals: Vitamin D 2000 IU oral once daily, Vitamin B6 100 mg oral once daily, Vitamin B12 100 mcg oral once daily, Omega-3 Fatty Acids 900 mg oral three times a day (600 mg EPA, 300 mg DHA)

Population: Breast Cancer patients undergoing either neoadjuvant or adjuvant therapy with docetaxel.

106 participants in total will be needed with accrual being completed in hopefully 1 years' time. Study Investigators will screen the candidates for the study.

Eligibility Criteria:
Inclusion Criteria:

* Female 18-70 years of age
* Biopsy proven invasive breast carcinoma
* Scheduled to receive docetaxel (3-6 cycles)
* Have values for liver (AST, ALT, Bilirubin) and renal function (CREAT), within 1.5 times normal values as drawn per standard of care.
* ECOG 0-2
* Be able to provide informed consent
* Willingness to adhere to regimen

Exclusion Criteria:

* Metastatic disease
* Any peripheral neuropathy
* Known HIV (testing not required)
* Diseases causing malabsorption i.e.: Inflammatory Bowel Disease, Celiac and Whipple's Disease
* Patients with seafood allergies
* Patients on Warfarin or with a documented clinically significant bleeding disorder
Blood Proteins in Predicting Treatment Benefit in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Cancer

RATIONALE: Studying samples of blood in the laboratory may help doctors learn more about cancer. It may also help doctors predict how well patients will respond to treatment.

PURPOSE: This research study is looking at proteins in blood samples to predict treatment benefit in patients with recurrent and/or metastatic squamous cell head and neck cancer.

OBJECTIVES:

* To identify head and neck squamous cell cancer patients who will benefit from treatment with the EGFR inhibitors (i.e., erlotinib hydrochloride, gefitinib, and cetuximab) and VEGF inhibitor (i.e., bevacizumab), based on predictive proteomic profiles in patient blood samples.

OUTLINE: This is a multicenter study.

Blood samples are analyzed for proteomic profile to determine good and bad prognoses in patients treated with or without EGFR inhibitors and/or a VEGF inhibitor.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of squamous cell head and neck cancer

  * Recurrent and/or metastatic disease
* Meets 1 of the following criteria:

  * Previously treated with EGFR inhibitors and/or VEGF inhibitor on 1 of the following clinical trials, and has available blood samples:

    * A Phase I/II Study of Bevacizumab (rhu MAb VEGF) in Combination With OSI-774 for Patients With Recurrent or Metastatic Cancer of the Head and Neck
    * A Phase II Study of 250-mg ZD1839 Monotherapy in Recurrent or Metastatic or Both Recurrent and Metastatic Squamous Cell Carcinoma of the Head and Neck
  * Previously treated with cetuximab and has blood samples available from protocol VU-VICC-HN-0356
  * Previously treated with conventional chemotherapy and has blood samples available from protocol VU-VICC-HN-0356

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Evaluating the Efficacy and Safety of Adebrelimab in Combination with Chemotherapy and LDRT As 1L Treatment for ES-SCLC

A multicenter, open-label, phase Ⅲ randomized controlled trial evaluating the efficacy and safety of adebrelimab in combination with chemotherapy and low-dose radiotherapy (LDRT) as first-line treatment for extensive-stage small cell lung cancer (SCLC)

A multicenter, open-label, phase III randomized controlled trial evaluating the efficacy andsafety of adbelizumab in combination with chemotherapy and low-dose radiotherapy (LDRT) as a first-line treatment for extensive-stage small cell lung cancer (SCLC). At least 202 participants will be enrolled in this study.

Eligibility Criteria:
Inclusion Criteria:

* Participants aged 18 to 75 years, regardless of gender;
* ECOG Performance Status (PS) score of 0-1;
* Expected survival duration of no less than 8 weeks;
* Histologically or cytologically confirmed extensive small cell lung cancer (according to the VALG staging system);
* Subjects must not have received systemic therapy or radical radiotherapy for extensive SCLC prior to enrollment.

Exclusion Criteria:

* Tissue classifications of mixed small cell lung cancer and non-small cell lung cancer;
* Patients who have undergone major surgical procedures within 28 days prior to the initial administration of the study drug, or those planning to undergo major surgery during the study period (as determined by the investigator);
* Receipt of live attenuated vaccines within 28 days before the first dose or planned for the duration of the study;
* Participation in another clinical trial within 28 days preceding initial dosing, involving any experimental agents;
* History of receiving chest radiotherapy or plans for intensive chest radiotherapy prior to systemic therapy;
* Any previous T-cell co-stimulation or immune checkpoint therapies administered;
* Documented history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\&amp;amp;#34;
Diphenylcyclopropenone (DPCP) as a Depigmenting Therapy in Extensive Vitiligo

The aim of the present work is to evaluate the efficacy and safety of diphenylcyclopropenone (DPCP) as a depigmenting therapy in extensive Vitiligo.

Depigmentation protocol: (Aghaei et al, 2005)

* Substance used: DPCP (FLUKA, Sigma-Aldrich, Saint Louis, MO (Missouri), USA) 98% pure powder.
* DPCP will be dissolved in acetone to obtain 2% solution.
* DPCP solutions will be kept in dark colored bottles at 4ºC (degree Celsius).
* Sequential dilution by acetone to yield 1%, 0.5%, 0.1%, 0.01%, 0.05 and 0.001%.
* Sensitization by DPCP concentration 2% will be applied to an area 5×5 cm on the forearm
* Two weeks following sensitization, treatment will be started by weekly applications of incremental concentrations of DPCP (between 0.001% and 2%) adjusted according to the patient's reactivity to the contact allergen. The aim will be to maintain mild contact eczema and itch for about 48 hours after application. Patients will be instructed to avoid direct sun exposure of the treated area and not to wash it for 48 hours after each application.

Patient follow-up: Patients will come for sensitization at week 0, then after 2 weeks to look for the allergic response, then weekly to reach the effective dose of DPCP. After reaching the effective dose, patients will come weekly to apply DPCP and to look for depigmentation, record possible side effects for 12 consecutive weeks.

Assessment of depigmentation:

For each treated area, response will be assessed as follows (van Geel et al., 2015):

* Digital clinical pictures will be used to evaluate the capacity to induce depigmentation and to assess the percentage of depigmentation per test area.
* Treatment results will be subsequently classified according to a grading system from 0 to 6 (0 = no effect, 1 = \<25%; 2 = 25-49%; 3= 50-47%; 4= 50-74%; 5=90-99%; 6=100%), corresponding to the grade of depigmentation.

Reporting any side effects: such as pain, erythema, blisters, erosions, hyperpigmentation, scarring, appearance of depigmentation in distant sites and/or systemic manifestations (Venkatesh et al,2018) .

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients of both genders ≥ 18 years.
2. Vitiligo universalis patients with cosmetically unacceptable residual pigmentation.
3. Extensive vitiligo vulgaris ≥ 50% body surface area (BSA) involvement with areas recalcitrant to repigmentation on exposed skin with consequent psychological impairment.

Exclusion Criteria:

1. Children.
2. Early, localized, segmental or any vitiligo case responsive to repigmentation treatment.
3. Pregnant and lactating females.
4. Patients with history of any malignancy.
5. Patients with active infectious or inflammatory dermatoses.
6. Patients with a history of hypertrophic scars or keloids.
7. Patients suffering from cardiac, hepatic or renal disorders.
Insular Inhibitory Neuromodulation to Reduce Cigarette Craving and Alter Brain Function in Smokers

The goal of this study is to determine if a specific experimental brain stimulation technique can be used as a non-invasive way to reduce cigarette cravings in current smokers. This study plans to learn more about the way an experimental technique called "transcranial magnetic stimulation" (TMS) affects a specific part of the brain, called the insula. Some research suggests that this part of the brain plays an important role in craving. The investigators plan to study the effects of TMS using standard surveys and magnetic resonance imaging (MRI) of subjects' brain.

For interested participants, this study requires a single 3 hour appointment, which will include MRI of the brain as well as TMS.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-55
2. Ability to provide informed consent
3. Self-reported current average daily cigarette consumption \>10/day for at least 1 year
4. Self-reported motivation to quit smoking

Exclusion Criteria:

1. MRI/TMS exclusions, including

   * Claustrophobia
   * Intracranial or spinal hardware
   * Pacemakers
   * MR-incompatible devices (Examples: pacemaker, deep brain stimulator, vagal nerve stimulator, cochlear implant, insulin pump, implanted medication pump, bone stimulator, implanted defibrillator)
   * History of metal objects or fragments in the eye or skull, including shrapnel or metal plates
   * History of stroke or other brain lesion
   * History of attempted suicide or suicidal ideation
   * Personal history of headaches, seizures, epilepsy, or status epilepticus
   * Family history of epilepsy
   * Medications known to lower seizure threshold (e.g., tricyclic antidepressants, antipsychotics, psychostimulants)
   * Increased intracranial pressure, hydrocephalus, or pseudotumor cerebri
   * Unstable coronary artery disease
   * Current pregnancy or positive urine pregnancy test
2. Neurological illness
3. Prior neurosurgery
4. Schizophrenia
5. Bipolar disorder
6. Current (within the last two months) major depressive disorder
7. Substance dependence or positive urinalysis for opiates, stimulants, cannabis, or sedative on the day of testing
8. Alcohol dependence or positive breath test for alcohol on the day of testing
9. Use of tobacco products other than cigarettes.
Clinical Evaluation of Cast21 Short Arm Product During Treatment of Distal Radial or Distal Ulnar Fractures

The primary objective of this study will be the collection of preliminary clinical evidence to indicate that Cast21 Short Arm Product is no worse than the current standard of care arm immobilization devices in pediatric patients.

A secondary objective will be to characterize the clinician and patient experience with the Cast21 Short Arm Product.


Eligibility Criteria:
Inclusion Criteria:

* Demographic characteristics: all persons ages 3 and above, regardless of the race and sex will be eligible to participate in this study
* Medical condition: participants must present with a closed, nondisplaced, or minimally displaced distal radius fracture and/or distal ulnar fracture that does not require a bone reduction procedure within 10 days from the date of injury
* Sizing: participants eligible for the Cast21 Short Arm Product must undergo sizing conducted by the clinical staff to ensure fit into one of the products (sizes XS-L)

Exclusion Criteria:

* Participants requiring a surgical intervention
* Participants with moderately displaced or angulated fractures or fractures requiring a bone reduction procedure.
* Participants with a known history of bone diseases e.g. osteogenesis imperfecta or other pathologic bone conditions
* Participants with pathologic fractures e.g., presence of bone cyst
* Participants who smoke
* Participants with pre-existing skin infection or condition of the lower arm (participants exhibiting only minor skin abrasions, lacerations, or skin condition might be eligible per clinical investigator's discretion)
Pain Rehabilitation Virtual Reality (PRVR): Innovations to Enhance Mobility in the Presence of Pain

The proposed research is a single arm feasibility trial of pain rehabilitation virtual reality (PRVR) aimed at measuring feasibility, acceptability and utility of VR as well as changes in physical function and fear for adolescents with chronic musculoskeletal pain. The intervention includes standard physiotherapy treatment including functional goal setting and progressive exercise.


Eligibility Criteria:
Inclusion Criteria:

* 10 to 17 years old
* Musculoskeletal pain (e.g. localized \[back, limb\], diffuse) not due to acute trauma (e.g. active sprain or fracture)
* English Language Proficiency

Exclusion Criteria:

* Significant cognitive impairment (e.g., brain injury)
* Significant medical or psychiatric problem that would interfere (e.g. psychosis, suicidality)
* Presents with a condition that interferes with virtual reality usage (e.g., history of seizure, facial injury precluding safe placement of headset, visual impairment, significant hearing impairment impact ability to follow audio instructions).
A Drug Interaction Study of BIIB074 and an Oral Contraceptive Regimen

The primary objective of this study is to evaluate the effect of multiple doses of a uridine diphosphate glucuronosyltransferases (UGT)-inducing oral contraceptive (OC) regimen (ethinyl estradiol and levonorgestrel) on the PK of BIIB074 at steady state; evaluate the effect of multiple doses of BIIB074 on the pharmacokinetics(PK) of an OC regimen (ethinyl estradiol and levonorgestrel) at steady state.

The secondary objective of this study is to evaluate the safety and tolerability of BIIB074 when administered alone and when coadministered with a UGT-inducing OC regimen containing ethinyl estradiol and levonorgestrel and to evaluate the effect of a UGT-inducing OC regimen (ethinyl estradiol and levonorgestrel) on the PK of the M13, M14, and M16 metabolites of BIIB074.


Eligibility Criteria:
Key Inclusion Criteria:

* Must have a body mass index between 18 and 32 kg/m\^2, inclusive.
* Females of childbearing potential must practice effective non-hormonal contraception during the study and be willing and able to continue contraception for 5 weeks after their last dose of study treatment,
* Must be in good health as determined by the Investigator, based on medical history and screening evaluations.

Key Exclusion Criteria:

* History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator.
* History of, or positive test result at Screening for, human immunodeficiency virus (HIV)
* Clinically significant abnormal laboratory test values, as determined by the Investigator, at Screening or Day -1
* Previous intolerance to OC medications
* Other unspecified reasons that, in the opinion of the Investigator or Biogen, make the subject unsuitable for enrollment.

NOTE:Other protocol defined Inclusion/Exclusion criteria may apply
Epileptic Seizures in Intensive Care Units

This retrospective observational cohort study is to assess and analyze clinical, electroencephalographic, laboratory, comorbidity, and treatment characteristics of Intensive care unit (ICU)-patients with epileptic seizures and to subsequently compare their characteristics with ICU-patients with status epilepticus (SE).

The aim of this retrospective observational cohort study is to get further insight into adult patients with epileptic seizures in ICUs in an academic tertiary medical care center regarding frequency, clinical and electroencephalogram (EEG) characteristics, treatment, course and outcome. This data could help understanding the epidemiology (including risk factors, influence of EEG), and to guide management and improve outcomes of affected patients.

Eligibility Criteria:
Inclusion Criteria:

* admitted to the ICU at the University Hospital Basel
* suffered from one or more epileptic seizures (detected clinically and/or by EEG) during their ICU-stay

Exclusion Criteria:

* patients with epileptic seizures transforming into Status epilepticus (SE)