cyrilzakka/clinical-trials huggingface dataset:
Vitamin D Supplementation to Prevent Vitamin D Deficiency for Children With Epilepsy

To determine the maintenance dose of vitamin D supplementation required for children with epilepsy to maintain normal vitamin D level.

children aged 2-16 years diagnosed with idiopathic epilepsy will be randomized to receive either cholecalciferol doses (400IU vs 1000IU) with follow up at 3 and 6 months post supplementation.

Eligibility Criteria:
Inclusion Criteria:

1. Children aged between 2-16 years who were diagnosed with Epilepsy and being treated with AEDs
2. Followed up in the outpatient pediatric neurology clinic at King Khalid University Hospital during the period of two years.

Exclusion Criteria:

1. Children with pre-existing vitamin D metabolism problems; because they are known to need different vitamin D doses and monitoring for clinical improvement:

   * Vitamin D dependent rickets
   * Malabsorption syndromes like celiac disease, inflammatory bowel disease
   * Renal disease
   * Hepatic disease
2. Children who are not safe to start vitamin D supplementation; because vitamin D supplementation will causes toxicity and induces nephrocalcinosis:

   * Hypercalcemia at baseline total corrected calcium \>2.5mg/dl
   * Vitamin D level \> 250 nmol/L
   * Urine calcium: creatinine ration \> 1.2 mol/mol, or \> 0.41g/g.
Use of Gastrografin in the Management of Fecal Impaction in Patients With Severe Chronic Constipation

Fecal impaction (FI) is a common cause of lower gastrointestinal tract obstruction, and it is the result of chronic or severe constipation and most commonly found in the elderly population. Gastrografin is a water soluble contrast mediate that could act as an osmotic laxative. It has been shown to confer a therapeutic beneﬁt in adhesive small bowel obstruction (SBO). The investigators speculate that gastrografin administrated orally may be more effective than enema in the treatment of fecal impaction induced intestinal obstruction.


Eligibility Criteria:
Inclusion Criteria:

1. A confirmed presence of fecal impaction diagnosed based on the following conditions: large amount of hard stool (impacted faecaloma) in colon or rectum; abdominal radiography was performed for assessment.
2. Rome III criteria for chronic constipation present for ≥8 weeks.

Exclusion Criteria:

1. Patients with a history of colorectal surgery or an organic cause of constipation; pregnancy.
2. Patients with long-term medical conditions potentially associated with constipation (ie, cystic fibrosis, cerebral palsy, hypothyroidism, spinal and gastric anomalies).
3. Patients with medical or psychiatric illness.
4. Patients with abnormal laboratory data or thyroid function.
To Evaluate Whether Naproxen and Darexaban (YM150) Interact in Their Effects

The primary objective of this study is to evaluate whether naproxen and darexaban which have different effects on blood coagulation influence each other in their effects. Also it will be investigated whether the blood levels of either drug are influenced by the presence of the other drug. In addition, the safety and tolerability of each drug and the combination of the drugs will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 18.5-30.0 kg/m2
* Male subjects must be non-fertile, i.e. surgically sterilized or must practice an adequate contraceptive method to prevent pregnancies

Exclusion Criteria:

* Known or suspected hypersensitivity to darexaban or naproxen or any components of the formulation used
* A contra-indication for the use of naproxen
* Any of the liver function tests (i.e. ALT, AST and bilirubin) above the upper limit of normal at repeated measures
* Any clinically significant history of any other disease or disorder - gastrointestinal, cardiovascular, respiratory, renal, hepatic, neurological, dermatological, psychiatric or metabolic as judged by the medical investigator.
* Any clinically significant abnormality following the investigator's review of the pre-study physical examination, ECG and clinical laboratory tests
* Use of any prescribed or OTC (over-the-counter) drugs (including vitamins, natural and herbal remedies, e.g. St. John's wort) in the 2 weeks prior to admission to the Clinical Unit, except for occasional use of paracetamol (up to 3 g/day)
* Regular use of any inducer of liver metabolism (e.g. barbiturates, rifampicin) in the 3 months prior to admission to the Clinical Unit
* Donation of blood or blood products within 3 months prior to admission to the Clinical Unit
* Any use of drugs of abuse, or smoking of more than 10 cigarettes (or equivalent) or more than 21 units (210 g) of alcohol per week within the 3 months prior to study
* Participation in any clinical study within 3 months or participation in more than 3 clinical studies within 12 months, prior to the expected date of enrolment into the study, provided that the clinical study did not entail a biological compound with a long terminal half life
CHERL, Connecting Primary Care Patients With Community Resources to Facilitate Behavior Change

The investigators want to find out if providing a Community Health Educator Referral Liaison (CHERL) helps practices help their patients change risky behaviors (tobacco use, physical inactivity, unhealthy diet, and risky drinking) by connecting patients to available services in the community or directly providing behavior change support.

What is this about? Prescription for Health (P4H) is a national initiative funded by the Robert Wood Johnson Foundation. Nine projects have been funded nationally in this second round to advance the goals of improving health behavior identification and delivery in primary care practice. Each project is conducted through a practice-based research network (PBRN). In Michigan, our PBRN is called the Great Lakes Research In Practice Network (GRIN).

What is the purpose of the CHERL project? In our study, we want to find out if providing a Community Health Educator Referral Liaison (CHERL) helps practices help their patients change risky behaviors (tobacco use, physical inactivity, unhealthy diet, and risky drinking) by connecting patients to available services in the community or directly providing behavior change support.

Primary care providers play a key roll in encouraging patients to choose healthy behaviors. However, effective behavior change requires long term follow up and support that may not be readily available within the office practice. CHERL can help provide or link to those services thus helping the healthy message promoted by the clinician to have a more powerful and lasting effect.

What is the CHERL intervention? With this funding, we will hire and train a CHERL to work with practices. The purpose of the CHERL is for him/her to help secure behavior change support for your patients either by referring to an available resource within the community or directly providing the service. This service is available to patients with or without chronic disease diagnoses (i.e, patients with diabetes, heart disease, hypertension, obesity, back pain, lung disease, or generally healthy with opportunities to change unhealthy habits).

Patients are referred to the CHERL and he/she will determine an appropriate next step for your patient - either referral to a community program or the CHERL will provide brief telephone counseling. The health care provider will receive feedback specifically on each patient referred.

In addition, some practices (consultant-enhanced) will receive additional assistance from the CHERL, as he/she serves as a consultant to the practice, helping the practice to identify systematic mechanisms for identification and referral of at risk patients to the CHERL.

Eligibility Criteria:
Inclusion Criteria:

* Patients, clinicians, and their staff participating in this GRIN study.

Exclusion Criteria:

* Patients, clinicians, and their staff who are not participating in this GRIN study.
To Elucidate the Effect of Mesenchymal Stem Cells on the T Cell Repertoire of the Kidney Transplant Patients

Despite being a miracle of modern medicine, solid organ transplant recipients are always at risk of rejection, and remain dependent on lifelong immunosuppression. Currently used immunosuppressive drugs suppress the potential of immune system and interfere with the metabolism of medications. Cellular therapies currently being investigated for this purpose require the use of ablative radiotherapy. The investigators are using a less toxic strategy by harnessing the immunosuppressive potential of the MSCs in the Kidney Transplant (KTx) recipients and studying immunomodulation mediated by these cells in the KTx patients.

Hypothesis MSCs interfere with signalling of Immune cells like T cells, B cells and Dendritic cells which leads to improve graft survival of renal transplant patients.

Aim To investigate effect of MSCs on immune cell repertoire in a donor specific mediated response.

The investigators aim to collect peripheral blood from 30 patients (10 patients for autologous cell infusion and 10 for allogeneic (donor derived cell infusion) at various time intervals following MSC therapy. 10 patients serve as controls on standard dose of drugs but without MSC infusion. This peripheral blood would be utilized for isolation of mononuclear cells and performing various immune assays on these cells in a donor specific response.

This is an open label type of study having 3 groups of patients: 1st group comprising of patients that would undergo allogeneic (donor-derived) mesenchymal stem cell infusion, 2nd group that would undergo autologous (patient-derived) mesenchymal stem cells and the third group (control group) without any stem cell infusion. All the three groups would have standard dose of Immunosuppressive drugs. Initially the investigators want to recruit 10 patients in each group and would increase the group size if the investigators get promising results on the follow up. The investigators plan to follow up the patients upto 1-2 years for immune based assays and then continue the follow up for atleast 5 years.

Eligibility Criteria:
Inclusion Criteria:

* All the renal transplant recipients participating in the trial should undergo primary kidney transplant.
* Donor should be living and related to the patient.
* Kidney transplant recipients and donor should be willing to give informed consent form.

Exclusion Criteria:

* There should be no prior sensitization to the patients.
* Patients should not be participating in any other study
* Patients should not be suffering from any autoimmune disorders.
BLI801 Laxative in Constipated Adults

A pilot study to evaluate the safety and efficacy of BLI801 vs. placebo in constipated adults.


Eligibility Criteria:
Inclusion Criteria:

* Constipated, defined by ROME III definition
* Subject has \< 3 satisfactory BMs during the run-in period

Exclusion Criteria:

* Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon
* Subjects taking laxatives or prokinetic agents that refuse to discontinue these treatments.
* Subjects who are allergic to any BLI801 component
* Subjects taking narcotic analgesics or other medications known to cause constipation.
* Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures
* Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days
* Subjects with an active history of drug or alcohol abuse
Evaluation of Tissue Perfusion in Peripheral Arterial Disease (EVTI-PAD)

In this prospective single-center observational study, arterial perfusion in patients with lower limb peripheral arterial disease will be assessed with standard diagnostic tools (toe pressure, trans-cutaneous oxygen pressure, ankle-brachial index and fluorescence angiography) before and after standard revascularization procedures (open surgery and/or angioplasty).

Arterial perfusion is an important parameter for the capacity of wound healing in patients with peripheral arterial disease (PAD). Quantifying tissue perfusion in affected patients can help in deciding whether further revascularization is necessary to achieve wound healing and limb salvage. Not only in PAD patients with ulceration, but also in patients with rest pain or life-style limiting claudication, the measurement of arterial perfusion before and after revascularization could influence further treatment regarding surgical/interventional procedures as well as medical treatment. Digital subtraction angiography (DSA) is the gold standard for the evaluation of peripheral arterial outflow and for quality assessment after revascularization. However, angiography only displays the larger arteries and not tissue perfusion itself, which is crucial for wound healing. In this study, the change of tissue perfusion measured with the different standard diagnostic tools (toe pressure, trans-cutaneous oxygen pressure, ankle-brachial index and fluorescence angiography) before and after standard revascularization procedures will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

- patients with symptomatic peripheral arterial disease (Rutherford categories 3-6) requiring revascularization.

Exclusion Criteria:

* patients younger than 18 years
* patients unable to give consent without legal guardians
* iodine allergy
* hyperthyroidism
* allergy to indocyanine green
* Glomerular filtration rate \<30ml/min/1.73m2
An Evaluation of the Safety and Performance of the CathVision ECGenius® System.

The primary objective is to evaluate the safety and technical performance of the CathVision ECGenius® System. The secondary objective is to benchmark the intracardiac electrogram signal quality compared to commercially available systems in patients undergoing assessment and ablation of cardiac arrhythmias.

A prospective, single center, open-label, single arm study to evaluate the safety and technical performance of the CathVision ECGenius® system.

Patients undergoing assessment and ablation of cardiac arrhythmias during an electrophysiology (EP) procedure, and who meet all inclusion criteria will be enrolled in the study and undergo the EP procedure. Intracardiac signals will be passively recorded using the CathVision ECGenius® System in parallel with a commercial EP recording system and later compared and evaluated. The investigational device will not be used for direct clinical care decisions or therapy. The EP procedure will be guided by the study site Standards Of Care.

Eligibility Criteria:
Inclusion Criteria:

* Patient is scheduled for catheter ablation or diagnostic electrophysiology procedure.
* At least 18 years of age.
* Able and willing to provide informed consent or obtain consent from a legally authorized representative (LAR).

Exclusion Criteria:

* Patient inability to understand or refusal to sign informed consent.
* Patient is a prisoner or under incarceration
* Patients who in the opinion of the physician are not candidates for this study.
Open Label, Phase I ZD6474 Head and Neck Cancer Study

The purpose of this study is to determine the maximum tolerated dose of ZD6474 given in combination with radiation or in combination with chemotherapy and radiation in patients with squamous cell carcinoma of the head and neck.


Eligibility Criteria:
Inclusion Criteria:

* Stage III-IV squamous cell carcinoma of the head and neck

Exclusion Criteria:

* No previous treatment for head and neck cancer, adequate cardiac function
Efficacy Of Hiatal Closure For GERD

The purpose of this protocol is to study the efficacy of hiatal closure for early GERD disease. The study team hypothesizes that hiatal closure for early GERD disease is an efficacious treatment of GERD.

Gastro-Esophageal Reflux Disease (GERD) affects 60 million Americans involving an estimated 20 million Americans dependent on long term medication to control symptoms and progression of the disease. Although surgical hiatal hernia repair and creation of an anti-reflux valve can correct the underlying cause of GERD by repairing the anatomic defect and reestablishing the competency of the lower esophageal sphincter (LES), only 24,000 patients annually undergo surgery for GERD. However, with the advent of minimally invasive laparoscopic techniques to treat GERD, more patients at early phases of the disorder are being surgically treated.

The traditional approach to surgical treatment of GERD has been hiatal hernia repair with Nissen fundoplication. However, fundoplication itself may be unnecessary for recovery of the lower esophageal sphincter. Several groups have demonstrated that partial or even minimal wrapping of the esophagus achieves equal control of GERD to complete wrapping. Despite extensive geometric and physics-based explanations for this observational enigma, the science underlying these highly reproducible observations across surgeons and continents remains poorly understood. Furthermore, outcomes following hiatal hernia repair alone for the treatment of GERD have not been studied since before the advances in laparoscopic technique.

Because of the high-volume gastrointestinal surgery center, the study team has the opportunity to rigorously study patient-centered outcomes and the disease processes as they are treated with this surgery. These outcomes after hiatal closure alone have not been published with the use of minimally invasive techniques where rigorous repairs can be achieved and thus, the study team is seeking this opportunity to demonstrate the efficacy of hiatal closure alone and recovery of the lower esophageal sphincter in those patients with symptomatic GERD and small hiatal defects. Publishing outcomes of this technique would represent a great leap forward in enhancing the knowledge base upon which to define the principles and techniques for the surgical treatment of GERD.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 50 years
* Able to provide informed consent
* BMI \<30
* Hiatal defect \<4cm on esophagram
* pH testing requirement: pH \<4 for \>5.5%
* Surgical candidate for hiatal closure only

Exclusion Criteria:

* Vulnerable subjects (children, prisoners, pregnant women) will be excluded.
Assessment of Sleep and Sleep Disruptors in Adolescents With Type 1 Diabetes

The goal of this study is to identify causes of insufficient sleep and sleep disruptors in adolescents with type 1 diabetes. For this study, adolescents will wear an actigraphy watch and complete sleep diaries for seven days. On completion of the seven days, they will complete several questionnaires regarding sleep, fear of hypoglycemia, and anxiety and depression. A subset of participants will additionally complete a qualitative interview session to obtain a deeper understanding of sleep disruptors and barriers and facilitators to improving sleep health.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with T1D at least 3 months
* Receive clinical care at the Barbara Davis Center

Exclusion Criteria:

* Have an active underlying sleep disorder, such as narcolepsy, insomnia, or untreated sleep apnea
* Participation in an interventional research protocol
* Unable to complete study procedures
NLP-Based Feedback to Improve Risk Comms and Informed Shared Decision Making

In this pilot study, the investigators will show feasibility of the NLP-based feedback system in 20 consultations of men with newly diagnosed prostate cancer. The investigators will recruit from the practices of up to 10 physicians who typically see these patients. The investigators will report the top five sentences from each consultation across key content areas (cancer prognosis, life expectancy, erectile dysfunction, urinary incontinence, and irritative urinary symptoms) to both patients and physicians within 2 weeks of the consultation.

The primary research procedures are:

1. Audio recording and transcribing treatment counseling discussions for 20 men with newly diagnosed clinically localized prostate cancers and utilize NLP to extract key content using the system described above.
2. Reports including the top five sentences by NLP probability for key content areas will be generated and will be provided to patients and providers within 2 weeks after each case.
3. For patients, decisional conflict and risk perception will be assessed before and after receiving the NLP-based feedback.
4. For physicians, the investigators will assess baseline quality of risk communication, any changes in individual physician communication over time, and accuracy of risk estimates for key content areas.
5. Within 2 weeks of receiving the NLP-based feedback, the investigators will conduct a 30-minute semi-structured interview with patients to obtain their opinions on the utility and ideal implementation strategy for the NLP-based feedback.
6. At the conclusion of the pilot trial, the investigators will conduct 30-minute semi-structured interview with counseling physicians to obtain their opinions on the utility and ideal implementation strategy for the NLP-based feedback.

Eligibility Criteria:
Inclusion Criteria:

1. Men undergoing initial treatment consultation for clinically localized prostate cancer;
2. Men with upgraded prostate cancer on active surveillance considering conversion to definitive local therapy.
3. Cedars-Sinai patient.
4. Ability to read and write in English.

Exclusion Criteria:

1. Under 18 years of age;
2. Subjects with difficulty communicating or dementia;
3. Non-English speakers, given that our NLP-based tools cannot be used with languages other than English;
4. Men with locally advanced or metastatic prostate cancer;
5. Men who have already been treated for clinically localized prostate cancer