cyrilzakka/clinical-trials huggingface dataset:
VITdAL@ICU - Correction of Vitamin D Deficiency in Critically Ill Patients

Study hypothesis:

High-dose vitamin D leads to a shorter hospital stay in critically ill patients

Vitamin D deficient patients will be randomized to receive either 540,000 IU cholecalciferol or placebo.

Inclusion criteria

* Age ≥18 years
* expected ICU stay ≥48 hours
* vitamin D deficiency: 25(OH)D ≤ 20 ng/ml
* feasibility of study drug application via nasogastric tube in cases where oral food intake is not possible

Exclusion criteria

* moribund patient expected to die within 24 hours
* hypercalcaemia (total calcium \>2.65 OR ion. calcium \>1.35 mmol/l)
* severely impaired gastrointestinal motility (ileus, residual gastric volume \> 400 ml)
* known history of recent kidney stones (≤ 1 year)
* known granulomatous diseases (tuberculosis, sarcoidosis)
* pregnancy

Primary endpoint

* hospital stay (hours; starting from ICU admission) Secondary endpoints
* percentage of patients with 25(OH)D ≥ 30 ng/ml at day 7
* serum calcium; phosphorus; 25(OH)D; 1,25(OH)D; PTH; osteocalcin; bALP; TRAP; urinary calcium

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* expected ICU stay ≥48 hours
* vitamin D deficiency: 25(OH)D ≤ 20 ng/ml
* feasibility of study drug application via nasogastric tube in cases where oral food intake is not possible

Exclusion Criteria:

* moribund patient expected to die within 24 hours
* hypercalcaemia (total calcium \>2.65 OR ion. calcium \>1.35 mmol/l)
* severely impaired gastrointestinal motility (ileus, residual gastric volume \> 400 ml)
* known history of recent kidney stones (≤ 1 year)
* known granulomatous diseases (tuberculosis, sarcoidosis)
* pregnancy
Arginine Replacement Therapy in COVID-19

This study aims to investigate if receiving doses of arginine (a protein in the body) will improve mitochondria function in children with COVID-19.

The study will be performed at the Children's Healthcare of Atlanta, Arthur M. Blank Hospital. Patients will be randomized to receive one of three doses of arginine three times a day for five days or at discharge whichever comes first.

In the early stages of COVID-19, it was believed that children were immune or had very mild disease. Given the unfolding pandemic, children's cases are exhibiting an increasing global trend and are associated with some serious complications in addition to more long-term complications such as multisystem inflammatory syndrome in children (MIS-C) and "Long Covid". A significant number of hospitalized and critically ill pediatric patients have now been documented, in addition to a high number of emergency department (ED) visits despite previous reports suggesting rare or mild disease in children. The research team and others have shown that severe COVID-19 and MIS-C are associated with acute arginine deficiency in both adults and children. There has been increased evidence of the role of the endothelium associated with severe inflammation in COVID-19. Low plasma arginine bioavailability has been implicated in endothelial dysfunction, immune regulation, and hypercoagulation. The research team also identified high sPLA2 levels in COVID-19 and MIS-C, an observation previously made in children with Kawasaki's Disease. Subsequent studies have shown that sPLA2 is associated with the pathobiology leading to COVID-19 mortality, with enzyme levels 10-fold higher in people who died vs. mild disease, and is also associated with Mito dysfunction. Not only could sPLA2 represent a prognostic indicator of disease severity, but it also represents a mechanism with potential therapeutic targets.

Information learned from the Mito activity in COVID-19 can contribute to further understanding of severe acute respiratory syndrome by coronavirus (SARS-CoV-2) infection. This data may help guide future treatment targets and strategies.

Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of COVID-19 requiring admission to the hospital for treatment of COVID-19 infection
* Age 3 years - 21 years of age

Exclusion Criteria:

* Severe hepatic dysfunction: ALT\> 6 x Upper limit of normal
* Renal dysfunction: Creatinine \> 1.5 x upper limit of normal or on dialysis
* Acute Stroke
* Pregnancy
* Allergy to arginine
* Past history of severe cardiac disease or significant cardiac surgery \[minor procedures like ventricular septal defect (VSD) repair are not an exclusion\]
* History of significant pulmonary disease \[Cystic Fibrosis, sickle cell disease (SCD)\]
* History of organ transplant
* History of metabolic or mitochondrial disease (including Diabetes)
* History of severe neurocognitive delays (severe cerebral palsy, anoxic brain injury)
* History of ventriculoperitoneal (VP) shunt or hydrocephalus
* PI discretion that the patient is not an ideal candidate for the study
* History of HIV of immune compromise
Facilitating Adolescent Self-Change for Alcohol Problems

This present multi-site investigation compares a voluntary brief intervention for adolescent alcohol problems to an educational comparison condition. Measures are taken at intake and at 4 and 12 weeks post intake to determine effectiveness of the intervention to promote personal change efforts and arrest progression of alcohol problems. This study tests cognitive mechanisms of change and treatment characteristics and processes associated with youth self-regulation to reduce or stop hazardous drinking.


Eligibility Criteria:
Inclusion Criteria:

* All 9th-12th graders at six schools from 3 sites across the country are eligible to participate, regardless of alcohol experience

Exclusion Criteria:

* exclusion prior to 9th grade and after 12th grade
A Study Comparing the Response of Patients With Hypertension to Amlodipine or Amlodipine Plus Benazepril.

Comparison of the safety and efficacy of the combination of amlodipine/Benazepril to amlodipine monotherapy in patients with non-essential hypertension, not controlled on amlodipine alone.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients 18 years of age or older.
* Male or female patients are eligible. Female patients must be either post-menopausal for one year or surgically sterile, or using effective, contraceptive methods such as barrier method with spermicide, or an intrauterine device.
* Patients with essential hypertension as measured by a validated device

Exclusion Criteria:

* Severe hypertension (DBP \> 115 mmHg diastolic and/or SBP \> 180 mmHg systolic).

Other protocol-defined exclusion criteria may apply.
Cerebellar RTMS in Patients with Multiple Sclerosis

To determine the efficacy of high frequency cerebellar repetitive transcranial magnetic stimulation on coordination in patients with multiple sclerosis.

Forty patients with multiple sclerosis suffering from ataxia less than five in EDSS score will be recruited from the outpatient clinic at Faculty of Physical Therapy as well as Kasr Al-Ainy Multiple Sclerosis unit (KAMSU), Cairo University. The study will be applied during the remission period. Patients will be assessed by Biodex balance system, Berg balance scale, Four square step test and Nine-Hole Peg Test to investigate coordination in both equilibrium and non-equilibrium. Patient will be divided into two groups.The study group will be treated by High frequecy cerebellar repetitive transcranial magnetic stimulation besides a tailored physiotherapy program, while the control group will be treated by Sham cerebellar repetitive transcranial magnetic stimulation with a tailored physiotherapy program as well. The treatment duration for each patient will take weeks.

Eligibility Criteria:
Inclusion Criteria:

* Clinically definite MS (relapsing, remitting and secondary progressive) patients
* Patients who are medically stable and Free from relapses three months before
* Ambulant patients without an assistive device and score less than 5 on the Kurtzke Expanded Disability Status Scale (EDSS)
* Patients receiving their disease modifying drugs but no medication changing during the previous three months.
* Patients who had MRI evidence of lesions in the cerebellum or in the cerebellar pedunculi.
* Right handed patients.
* Severity of ataxia range from 4 to 10 according to scale of assessment and rating ataxia (SARA).
* Did not apply cerebellar transcranial magnetic stimulation before.

Exclusion Criteria:

* Any other neurological deficits or orthopedics abnormalities.
* Ataxic manifestations for other cause rather than Multiple Sclerosis.
* Other neurological manifestations (e.g. spasticity, visual loss)
* Secondary musculoskeletal complication such as contractures or deformities. Cardiovascular, pulmonary, hepatic, renal, hemopoietic and thyroid diseases.
* Pregnant women.
* Addicted individuals.
* Previous surgeries in the brain.
* Any magnetic or metallic devices implanted (like cochlear implants) .
* Psychotic deficits or history of epileptic seizures.
Molecular Urine Tests for Prostate Cancer

Prostate cancer is the second leading cause of cancer related deaths among men in the United States.1 Although still controversial, there is growing evidence that early detection will reduce prostate cancer mortality. Currently the most useful biomarker to aid in early detection is measurement of serum prostate specific antigen (PSA) levels. Despite the value of PSA it has substantial limitations. To overcome the limitations of total PSA testing, there is emerging evidence demonstrating that relevant cancer biomarker can be detected in urine.

Patients who present to the urology clinic for a radical prostatectomy will be asked to enter this study. After obtaining informed consent, the following exam and specimen collection scheduled will be followed:

Visit 1 (pre-op):

Digital Rectal Exam (DRE) - Voided urine collection \& serum collection

Visit 2 (time of prostatectomy):

Under anesthesia- catheterized urine collection and serum collection

Visit 3 (approximately 8 days post-prostatectomy):

Catheterized urine collection

Visit 4 (approximately 3 months post-prostatectomy):

Voided urine collection and serum collection

Some patients will not have the serum collection at visits 1, 2, and 4. The patients will be notified as to whether or not their blood will be drawn during the visits. Pre-operative Digital Rectal Exam, urinary catheterization and blood draws are part of standard of care in this patient population with localized prostate cancer. The catheter will be inserted during the time of surgery preparation in the operating room and removed during the post operative clinic appointment.


Eligibility Criteria:
Inclusion Criteria:

* Those scheduled to undergo radical prostatectomy for the treatment of prostate cancer.

Exclusion Criteria:

* minors
Factors Affecting the Cure of Overactive Bladder Syndrome in Women Underwent Mid-urethral Sling Procedure

We will estimate the incidence of patients with overactive bladder syndrome after surgery and explore related predictors.

At present, around 30% of women with stress urinary incontinence have overactive bladder syndrome after mid-urethral sling procedure. But its predictive factor is still unclear. We will estimate the incidence of patients with overactive bladder syndrome after surgery and explore related predictors. In addition, we will explore the cure rate and predictors of cure of overactive bladder syndrome after the mid-urethral sling procedure for women with stress urinary incontinence. The above results will be used as a reference for preoperative and postoperative consultation.

Eligibility Criteria:
Inclusion Criteria:

* All women with stress urinary incontinence who underwent mid-urethral sling procedure from January 01, 2008 to July 31, 2019 will be reviewed.

Exclusion Criteria:

* Patients undergoing other gynecological operations at the same time, except for cystoscopy.
Feasibility and Effectiveness of tDCS in the Treatment of Post-stroke Fatigue (EFECTS).

This study aims to analyze the use of non-invasive brain stimulation (tDCS) is beneficial for the treatment of post-stroke fatigue.

A single-blind randomized clinical trial will be conducted. The intervention will consist of 8 20-minute tDCS sessions conducted over four weeks. The stimulation will be performed by applying the stimulation to the dorsolateral prefrontal cortex on the left side (F3) and the cathode will be at point O2 of the right hemisphere. The study will consist of two groups: the control group in which sham stimulation will be applied and therapeutic education and aerobic exercise; the intervention group in which stimulation, therapeutic education and therapeutic exercise will be carried out.

Eligibility Criteria:
Inclusion Criteria:

* First stroke within 45 (+-7) days of the ischemic or hemorrhagic episode.
* Ability to understand and execute simple instructions
* Over 18 years.
* Fatigue Scale of fatigue severity with a score greater than or equal to 24

Exclusion Criteria:

* A score \> 2 on the modified Rankin Scale (mRS) before the stroke.
* Patients with decompensated cardiorespiratory and/or psychiatric pathology.
* Comorbidity causing disproportionate fatigue, such as long-term COVID.
* Patients who are cancer survivors or who are undergoing cancer treatment.
* Patients with a history of epilepsy or who are taking antiepileptic medication.
* Patents with major depression.
Cryoballoon Pulmonary Vein Isolation for Atrial Fibrillation With Heart Failure

The combination of atrial fibrillation (AF) and heart failure (HF) is common and implies a poor prognosis. Pulmonary vein isolation is an established method for the treatment of symptomatic AF in patients with normal heart function and has been shown to be more effective than drug therapy. Recently, radiofrequency ablation has shown a positive effect in patients with AF and HF. POLAR-HF has been designed to investigate efficacy and safety of cryoballoon pulmonary vein isolation in patients with paroxysmal or persistent AF and severe HF (LVEF ≤ 40%).


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic paroxysmal or persistent atrial fibrillation
* Patients with severe heart failure (LVEF ≤40%, assigned to heart failure group)
* Patients with normal cardiac function (assigned to control group)
* Age \> 18 years
* Consent capacity

Exclusion Criteria:

* Age under 18 years
* Pregnancy
* Lack of consent capacity
Clinical Utility of WATS3D: A 5-Year Prospective Study

The purpose of this study is to create a registry (collect data and keep it in a research database) to learn more about two methods of taking small tissue samples from your esophagus (the esophagus is the tube that carries food and liquid from your mouth to your stomach). The two methods of sampling are: 1) Using forceps that take biopsies (small tissue samples) from your esophagus, and 2) Using a brush that also takes biopsies from your esophagus.

This study will look at the impact of the brush biopsy results on your doctor's decisions about your future care and treatment.

In addition , by recording the results of all your biopsies over 5 years, it may be possible to find out if the brush biopsy, forceps biopsy, or both can predict which patients with heartburn develop Barrett's esophagus, (an abnormality in the esophagus that may lead to cancer), and which patients with Barrett's esophagus develop precancer and cancer.

You are being asked to participate in the study because you are receiving an upper endoscopy (a procedure where a tube with a light and camera are inserted in your mouth and down your throat) with forceps and brush biopsies of your esophagus as part of you standard clinical care, and you are at least 18 years old.

Eligibility Criteria:
Inclusion Criteria:

* Able to read, comprehend and complete the IRB-approved consent form
* Aged 18 or older
* Meet one of the following:
* Patients with heartburn or regurgitation undergoing a screening EGD, who undergo WATS3D sampling and forceps biopsies for suspicion of BE, or
* Patients with known BE with or without dysplasia undergoing a surveillance EGD with WATS3D biopsies and forceps biopsies, or
* Patients who have undergone endoscopic eradication (i.e. radiofrequency ablation or cryoablation) who are undergoing surveillance EGD following the establishment of complete eradication of intestinal metaplasia (CEIM)
* Only patients who undergo both forceps biopsies and WATS3D of the esophagus will be included.

Exclusion Criteria:

* Pregnancy at time of endoscopy
* Unresolved drug or alcohol dependency that will limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions or follow-up guidelines
* Medical condition that will likely prohibit completion of a 5 year study
Use of Serious Game Simulation on Newborn Resuscitation Education

Neonatal death is one of the important indicators showing the development level of countries. Many newborn deaths are preventable. Preventable neonatal deaths arise from events such as birth asphyxia at the time of delivery. Nursing students receive neonatal resuscitation training with classical training methods and graduate without the opportunity to experience it in a clinical setting. The aim of the study is to evaluate the effectiveness of web-based serious game simulation method in neonatal resuscitation training given to nursing students.

The study was planned as a randomized controlled trial with a single blind, pretest-posttest design. This study will be conducted in the Fall Semester of the 2020-2021 Academic Year with nursing students studying in the 3rd grade of Akdeniz University Faculty of Nursing between October and December 2020. An intervention and control group (intervention group: 50, control group: 50) will be formed from 100 students who accepted to participate in the study. Participants will be randomly allocated to one of the two groups. Pre-test and post-test will be applied to both groups before and after the training. Neonatal resuscitation training will be given online to the intervention and control group. After the theoretical training, web-based neonatal resuscitation serious game simulation will be applied to the intervention group. Ethics Committee and Institutional Permission was obtained for the study. In addition, written consent will be obtained from the participants. Statistical analysis will be done using SPSS 23.0 and significance will be evaluated at p \<0.05. Support will be received in the analysis phase of the Statistical Information Unit of Akdeniz Universit It is predicted that the new information obtained from the data of the research will guide the methods used in education and new researches.

Eligibility Criteria:
Inclusion Criteria:

* Students who are volunteers, Those who attend the Neonatal Nursing Course, Nursing students in the 3rd grade, Students with laptops

Exclusion Criteria:

* Those with neonatal resuscitation certificate, Students without internet access
Pregabalin as Treatment for Alcohol Use Disorder

The proposed protocol is an 8 week open label outpatient pilot trial of the safety and efficacy of pregabalin (Lyrica) in the treatment of alcohol use disorder. The primary objective of the study is to determine the efficacy of pregabalin in promoting alcohol abstinence among individuals with an alcohol use disorder.

The proposed protocol is an open label outpatient pilot trial of the safety and efficacy of pregabalin (Lyrica) in the treatment of alcohol use disorder. Pregabalin is commonly used for the treatment of pain issues such as fibromyalgia (chronic pain in your body), diabetic nerve pain, spinal cord injury nerve, and pain after shingles. We plan to enroll 20 participants in an 8-week trial.The ideal dosing, tolerability, and safety of pregabalin will be tested in outpatients with Alcohol Use Disorder (AUD). The primary objective of the study is to determine the efficacy of pregabalin in promoting alcohol abstinence among individuals with an alcohol use disorder.

Eligibility Criteria:
Inclusion Criteria:

* Meets DSM-5 criteria for current alcohol use disorder
* Reports drinking a minimum of 5 standard drinks for men or 4 standard drinks for women at least 4 days per week over the past 28 days
* Between the ages of 18 and 65
* Able to provide informed consent and comply with study procedures

Exclusion Criteria:

* Subjects with any current psychiatric disorder as defined by DSM-5, other than AUD, that in the investigator's judgment might require intervention over the course of the study.
* Subjects receiving psychotropic medication treatment
* Evidence of moderate-to-severe alcohol withdrawal (CIWA-Ar \> 13)
* History of alcohol withdrawal seizures or alcohol withdrawal delirium
* History of allergic reaction to candidate medication (pregabalin)
* Pregnancy, lactation, or failure in females patients to use adequate contraceptive methods
* Unstable physical disorders which might make participation hazardous
* Subjects who have a current DSM-5 diagnosis of moderate or severe substance use disorder, with the exception of alcohol, nicotine and caffeine use disorders. A diagnosis of a mild substance use disorder will not be exclusionary, as long as the current primary substance use disorder is alcohol.
* Are legally mandated to participate in alcohol use disorder treatment program
* Cognitively impaired
Radiation Therapy During and After Lumpectomy in Treating Women With Stage I or Stage II Breast Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy during and after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying the side effects of giving radiation therapy during and after lumpectomy and to see how well it works in treating women with stage I or stage II breast cancer.

OBJECTIVES:

* To determine the feasibility and acute tolerability of intraoperative electron radiotherapy (IOERT) and external-beam radiotherapy (EBRT) after lumpectomy in women with stage I or II breast cancer treated with breast conservation therapy.
* To determine the local tumor control and distant tumor control rates in these patients.
* To determine the long-term side effects and cosmetic outcome of IOERT to the tumor bed and EBRT after lumpectomy in these patients.

OUTLINE: Patients undergo standard lumpectomy. Patients with negative lymph nodes undergo intraoperative electron radiotherapy to the tumor bed. Beginning 2-8 weeks after surgery, patients undergo whole breast external beam radiotherapy once daily for 24-27 fractions.

After completion of study treatment, patients are followed periodically for up to 8 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed primary invasive breast carcinoma, meeting the following criteria:

  * Stage I or II disease (T1-T2, N0, M0)
  * Tumor pathologically determined to be ≤ 5 cm in diameter
  * Single, discrete, well-defined primary tumor
* No multicentric disease and/or diffuse malignant appearing microcalcifications

  * Any microcalcifications must be focal

    * Specimen radiograph is required after lumpectomy to assure removal of all malignant appearing calcifications
* No axillary lymph node involvement

  * Axillary lymph node status can be determined by level I and II lymph node dissection or sentinel lymph node sampling
* Must have pathologically negative surgical margins
* No evidence of metastatic breast cancer
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* Menopausal status not specified
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No pre-existing collagen vascular disease except rheumatoid arthritis that does not require immunosuppressive therapy

PRIOR CONCURRENT THERAPY:

* No prior irradiation to the area of planned radiation field
* Concurrent hormone therapy allowed