cyrilzakka/clinical-trials huggingface dataset:
Metabolic Acidosis and Vascular Function in Patients With Chronic Kidney Disease

Cardiovascular disease (CVD) is the leading cause of death in patients with chronic kidney disease (CKD) and large artery damage is a major factor that contributes to death. Metabolic acidosis is a common complication of CKD resulting from an inability of the diseased kidney to excrete the daily dietary acid load and it is associated with all-cause mortality in patients with CKD. However, the effect of treatment of metabolic acidosis with oral sodium bicarbonate on endothelial dysfunction and arterial stiffness in patients with CKD has not been evaluated. The investigators propose a prospective, randomized, controlled, open-label 14-week crossover pilot study examining the effect of treatment of metabolic acidosis with oral sodium bicarbonate on vascular endothelial function in 20 patients with CKD stage IV with metabolic acidosis.


Eligibility Criteria:
Inclusion Criteria

* Age 40-70 years
* CKD stage IV (eGFR 15-29 ml/min/1.73m2; stable renal function in the past 3 months)
* Serum bicarbonate level of \< 20 and ≥ 16 meq/L (at least 2 consecutive weekly measurements)
* Body mass index \< 40 kg/m2 (FMD measurements can be inaccurate in severely obese patients)
* Ability to give informed consent
* Stable anti-hypertensive, diabetic and lipid lowering regimen for at least one month prior to randomization

Exclusion Criteria:

* Significant comorbid conditions that lead the investigator to conclude that life expectancy is less than 1 year
* Uncontrolled hypertension
* Expected to undergo living related kidney transplant in next 6 months
* Expected to start dialysis in next 3 months
* Overt congestive heart failure
* Use of sevelamer
* Use of calcium carbonate
Gastric Volume in Patients on GLP-1 Medications

Evaluating gastric volume in patients on GLP-1 RA medications

Glucagon like peptide 1 (GLP-1) receptor agonist (RA) medications have in recent years been approved for use in children with type 2 diabetes mellitis (DM) and obesity. The side effects of these medications include nausea and vomiting, and in the adult literature, delayed gastric emptying has been described. Due to the likelihood of delayed enteric motility, standard nil per os (NPO) guidelines may not be sufficient to minimize the chance of aspiration of gastric contents before anesthesia and surgery in patients receiving GLP-1 RA medications.

Investigators seek to measure the gastric volume of children on GLP-1 RA medications who are appropriately NPO (greater than/equal to 8 hours for solids and greater than/equal to 1 hour for clear liquids) using standard institutional NPO guidelines. The secondary objective is to measure the gastric volume of children not on GLP-1 RA medications, but with type 2 diabetes mellitis or obesity and/or type 1 DM.

The only study intervention is the addition of a gastric ultrasound. The gastric ultrasound is a non-invasive mode of imaging using sound waves with no known safety risks. The ultrasound will be performed while the subject is awake and will take less than 5 minutes.

Eligibility Criteria:
Inclusion Criteria:

Fasting Diabetic On GLP-1 RA

Exclusion Criteria:

Prior surgery that affects gastric anatomy
Collection of Blood From Patients With Prostate Cancer

Background:

* It is not fully understood why prostate cancer in some men becomes androgen-independent (no longer responds to anti-androgen medication), but genetics likely plays an important role.
* Genes contain the hereditary information that is passed down from parents to children. Although everyone has the same set of genes, individuals can have different forms of the same gene.
* Differences in genes may explain, at least in part, why some people develop a more aggressive form of prostate cancer than others.

Objectives:

-To obtain blood samples from patients with prostate cancer to try to identify gene differences associated with progression to the androgen independent state.

Eligibility:

-All participants participating in NCI prostate cancer protocols.

Design:

* Participants with prostate cancer are evaluated in the NCI s Medical Oncology Clinic.
* Blood samples are collected at the initial visit or at follow-up visits.
* DNA (genetic material) and white blood cells are extracted from these samples to be used for genotyping and establishment of cell lines.
* Gene variations are correlated with prostate cancer prognosis and prognostic indicators.

Objectives:

-To obtain blood samples from patients with prostate cancer for genotyping analyses.

Eligibility:

- All patients seen in the NCI prostate cancer clinic are eligible.

Design:

* Patients with a prior diagnosis of prostate cancer will be evaluated in the GMB Clinic, NCI.
* Blood samples will be collected after the participant signs the protocol consent form. In general, blood will be collected for genomic DNA one time for this study. Extra samples may be requested if the original sample was not enough. The additional sample can range from one to two tubes of blood (approximately 2-3 teaspoons total). Genomic DNA and white blood cells will each be extracted from these samples to be utilized for genotyping and establishment of individual cell lines.
* Genetic variance will be correlated with prostate cancer prognosis (i.e. time from diagnosis to death) and prognostic indicators (i.e. histological tumor grade).
* Blood samples for the extraction of cell-free DNA (cfDNA) and cell-free RNA (cfRNA) may be collected at multiple timepoints for future investigations
* Healthy controls will not be compared and no correlations will be made with prostate cancer susceptibility.

Eligibility Criteria:
* INCLUSION CRITERIA:

Individuals 18 years of age and older are eligible.

Individuals with a diagnosis of prostate cancer are eligible.

EXCLUSION CRITERIA:

Children are not eligible.
Conventional Laparoscopic Versus Laparoendoscopic Single Site Donor Nephrectomy in Living Donor Kidney Transplantation

Laparoscopic nephrectomy (removal of the kidney) is the most common procedure for people donating a kidney to be used for living donor kidney transplantation. Laparoscopic donor nephrectomy (LDN) was a great advance in the field of living donor kidney transplantation due to the many advantages it offers over open nephrectomy, including significantly shorter hospitalization and recovery time, and significantly improved cosmetic result related to the nephrectomy scar(s). More recently, a new procedure has been introduced to the field of laparoscopic nephrectomy, called laparoendoscopic single site donor nephrectomy (LESS-DN). In the LESS-DN procedure, a single natural orifice (the umbilicus or belly button) is used as the single incision site through which the entire donor nephrectomy is performed. The LESS-DN procedure may further decrease donor morbidity by further decreasing length of stay, lessening recovery time, and improving satisfaction with the surgical scar. The investigators propose to evaluate conventional LDN versus a LESS-DN in a randomized, controlled trial in living kidney donors. The investigators will compare operative times and intra-operative donor management, intra- and post-operative complications, pain scores, analgesic requirements, length of stay, recovery parameters, surgical scar satisfaction, and function and survival of the transplanted kidney for the two groups of subjects: (1) the group that has the conventional laparoscopic donor nephrectomy; and, (2) the group that has the laparoendoscopic single site donor nephrectomy.


Eligibility Criteria:
Inclusion Criteria:

* All patients scheduled to undergo laparoscopic living donor nephrectomy will be eligible for the study.

Exclusion Criteria:

* There are no exclusion criteria.
Nutritional Supplements and Performance During Visual Field Testing (B3 Vitamin)

This study seeks to test whether these over-the-counter nutritional supplements have an impact on patients' performance during visual field testing.

Glaucoma is the leading cause of irreversible blindness worldwide. The most important test to detect progression is visual field testing. Visual field testing is the reference standard to measure visual function in glaucoma. It is called called standard automated perimetry (SAP). However, this test is very subjective, often unreliable, and variable. One of the main causes of unreliable tests is the lack of attentiveness or concentration during the test. Previous studies have shown that listening to Mozart or taking vitamin B12 can improve the reliability of this test. Recent studies have suggested that over-the-counter medications such as nicotinamide (vitamin B3) and pyruvate can also improve the performance during this test. This can ultimately reduce costs due to repeated testing and increase doctor's certainty when analyzing the results of this test.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of primary open-angle glaucoma;
* Visual field loss on 24-2 standard automated perimetry (SAP) worse than -3 decibels (dB) and better than -12 dB in both eyes;
* Best corrected visual acuity better than 20/40 in both eyes;
* Prior experience with 24-2 visual fields (at least 3 tests done in the past 3 years).

Exclusion Criteria:

* Significant cataract or media opacity;
* Diagnosis of dementia, Alzheimer's, and other neurological diseases;
* Current use or use in the past 1 month of nutritional supplements;
* Inability to take or intolerance to nicotinamide and/or pyruvate.
BIGlobal Intervention Study: Improving Diagnosis and Management of Suspected Brain Infections Globally

Background: Patients with suspected brain infections pose major challenges to low and middle income countries, including their disproportionately high burden, diverse causes with inadequate surveillance, requirement for invasive and expensive tests, and the difficulty of management without a clear diagnosis. This is all compounded by resource and system constraints. Few studies have attempted to improve the care of these people in resource-limited settings.

Aim: This study sets out to improve the diagnosis and early management of people with suspected acute (\<28 days of symptoms) brain infections in low and middle income countries, using a coordinated thematic approach.

Outcomes: The primary outcome will be proportion of people with suspected acute brain infection receiving a diagnosis. Secondary outcomes will include mortality, length of stay in hospital, quality of life, degree of disability, and proportion having a lumbar puncture test.

Participants: Children and adults with features consistent with an acute brain infection, including meningitis and encephalitis, will be recruited at a variety of hospitals in Brazil, India and Malawi.

Study procedures: An assessment of current practice and capabilities at each hospital, including patient and sample journey observations and interviews with healthcare staff, will identify barriers to optimal care. Using this, a sustainable pragmatic multi-component intervention will be produced, with components modifiable to each hospital's needs. Outcomes will be reassessed post-intervention.


Eligibility Criteria:
Inclusion Criteria:

1. Adults, infants and children presenting to a study hospital with symptoms and/or signs suggestive of acute brain infection, which could be suspected encephalitis, suspected meningitis, or alternative features raising suspicion of brain infection.
2. Symptom duration of less than 4 weeks.

Exclusion Criteria:

1. Neonates, i.e. children under the age of 28 days.
2. People with pre-existing indwelling ventricular devices (e.g. extra-ventricular drains, ventriculo-peritoneal shunts) or other implants in contact with the meninges or brain (e.g. deep brain stimulators).
3. People without an indwelling device, having undergone neurosurgical procedures within the preceding 12 months.
Mindfulness-Based Art Therapy for Cancer Patients

The purpose of this study is to determine whether cancer patients who receive the mindfulness-based art therapy (MBAT) program demonstrate improvement in health-related quality of life, a reduction in stress-related symptoms, and enhanced coping responses.

Psychosocial interventions, especially supportive-expressive group therapies, have been associated with significant improvements in health status, quality of life and coping behaviors, in patients with cancer. The purpose of the proposed pilot research study is to investigate a newly developed group therapy for cancer patients, MBAT. This proposed, randomized, controlled study follows a successful preliminary investigation of MBAT conducted at Thomas Jefferson University Hospital. MBAT integrates known benefits of art therapy, group therapy, and mindfulness-based stress reduction. Each of these fundamentally different modalities has documented usefulness in the treatment of cancer patients. The multi-modal approach is designed to enhance both the supportive and expressive aspects of the group experience. The study will be done with 96 patients who have a variety of cancer types. Participants will be matched for age and assigned randomly to either the MBAT experimental group or a non-intervention control group. Both groups will continue to receive their usual oncologic/medical care. The MBAT program consists of eight weekly meetings of two and one half-hours in length. At the end of the eight weeks, participants in the control group will be crossed over to the experimental intervention arm for an additional eight weeks. Participants will be assessed pre- and post-intervention on measures of health-related quality of life, psychological distress, and coping, using standardized outcome instruments (SF-36, SCL-90-R and COPE). Our long-term goal is to collect sufficient data to determine the overall efficacy of this promising intervention and to identify which patients are particularly likely to benefit from MBAT.

Eligibility Criteria:
Inclusion:

* Diagnosis of cancer or cancer recurrence within the past 2 years.
* Able to tolerate 8 weekly groups, 2 1/2 hours in length

Exclusion:

* Less than 4 months from original or recurrent diagnosis or beyond 2 years
* Physically unable to attend groups
* Non-stabilized major mental disorder
* Children
* Comprehension of written and spoken English at a level of less than 4th grade.
Effectiveness of Blood Flow Restriction Exercise Therapy to Reduce Pain in Knee Osteoarthritis Patients

Resistance training of knee extensor muscles is being used in physiotherapy management in knee osteoarthritis (OA) to improve pain and physical function. Blood flow restriction (BFR) has been suggested to improve pain and increase muscle strength in healthy subjects and certain diseases. Although there are clinical studies suggesting improvements in knee osteoarthritis symptoms after 4-12 weeks of exercise with BFR, the acute effects of the intervention have not been known.

This study aims to assess the effectiveness of low load exercise therapy combined with BFR on acute pain reduction and within 24 hours post-intervention on people with knee OA compared to a placebo group.

This study will take place in Athens, Greece, as part of the postgraduate MSc program of the Physiotherapy department of the University of West Attica.

A double-blinded randomised clinical trial with a total of 42 participants will be randomly assigned to the intervention (n=21) or the control group (n=21).

The intervention group will complete a single exercise session with BFR 80%, 30% 1RM, while the control group will have sham BFR, 30% 1RM.

Pain Pressure Threshold (PPT) will be assessed with the use of a digital pressure dynamometer.

Eligibility Criteria:
Inclusion Criteria:

* Current osteoarthritis clinical diagnosis according to either European League Against Rheumatism (EULAR) or American College of Rheumatology (ACR) criteria
* VAS/NRS Knee pain ≥3/10 during activity

Exclusion Criteria:

* Previous experience with BFR
* Has followed knee exercise or kinesiotherapy program in the past 3 months
* New medicines in the past 3 months
* Any lower limb surgery in the past 6 months
* Knee arthroplasty surgery (Knee replacement)
* Any active healing process affecting walking (fracture, sprain, strain, etc.)
* Diagnosed with rheumatologic/neurologic disease affecting functionality
* Diagnosed or history of heart or vascular diseases
* Diagnosed with respiratory/metabolic disease
* Personal history of cancer
* Cognitive problems
* Pregnancy (only for female participants)
* Any other indication not to participate in exercise
GB004 in Adult Subjects With Active Ulcerative Colitis

This is a Phase 1b, randomized, double-blind-, placebo-controlled, multi-center study to evaluate the safety, tolerability, and PK of GB004 in adult subjects with active ulcerative colitis. Target engagement and effect of GB004 on pharmacodynamic biomarkers will be assessed.

The safety, tolerability, pharmacokinetics, and pharmacodynamics of GB004 will be explored in a Phase 1b randomized controlled trial in adults subjects with active ulcerative colitis (UC). Subjects will be evaluated based on incidence of AEs, laboratory parameters, GB004 serum and colonic tissue concentrations, and changes in the signs and symptoms of UC.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-74, receiving therapy for active ulcerative colitis confirmed by Mayo Score assessment, and evidence of colonic inflammation.

Exclusion Criteria:

* Evidence of Crohn's disease, indeterminate colitis, or presence of bacterial or parasitic infection.
* Patients receiving biologic agents and experimental agents are excluded.
Corifollitropin Alfa Versus Follitropin Beta in High Responders

The purpose of this randomized controlled trial (RCT) is to compare a single injection of corifollitropin-alfa versus daily injections of follitropin beta regarding the number of oocytes retrieved, hormonal profile and follicle development in patients with high response undergoing ovarian stimulation for in vitro fertilization treatment using a gonadotropin-releasing hormone (GnRH) antagonist protocol combined with GnRH agonist trigger and cryopreservation of all embryos.

Corifollitropin alfa, a novel fusion protein lacking luteinizing hormone (LH) activity, has a longer elimination half-life and extended time to peak levels than recombinant follicle stimulating hormone (rFSH). A single injection of corifollitropin alfa may replace seven daily injections follitropin beta during the first week of ovarian stimulation, reducing patient discomfort.

The purpose of this RCT is to compare a single injection of corifollitropin-alfa versus daily injections of follitropin beta regarding the number of oocytes retrieved, as well as hormonal profile and follicle development in patients with high response undergoing ovarian stimulation for IVF using a GnRH antagonist protocol. In addition, incidence of unexpected ovarian hyperstimulation syndrome (OHSS) will be evaluated, although it is anticipated that GnRH agonist triggering will eliminate occurrence of the syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-40 years
* Polycystic ovaries (PCO) or polycystic ovary syndrome (PCOS)
* no endometriotic cyst

Exclusion Criteria:

* Patients with poor response
* Patients using human chorionic gonadotropin (hCG) for triggering final oocyte maturation.
A Study to Look at Performance of MICRUSFRAME and GALAXY Coils for the Treatment of Intracranial Aneurysms

A post-market registry evaluating ruptured/unruptured aneurysms treated with MICRUSFRAME and GALAXY coils

A registry to collect real world data on the use of Cerenovus coils. The study will be a post-market registry evaluating ruptured/unruptured aneurysms treated with MICRUSFRAME and GALAXY coils

Eligibility Criteria:
Inclusion Criteria:

1. Patient is between 21 and 80 years of age
2. Patient has an intracranial saccular aneurysm, ruptured or unruptured, suitable for embolization with coils
3. Patient is able and willing to comply with protocol and follow-up requirements

Exclusion Criteria:

1. Pre-planned staged procedure on unruptured aneurysm
2. More than one aneurysm requiring treatment during the course of study
3. Fusiform aneurysm
A Long-Term Extension Trial From Late Phase II of SPM 962 in Patients With Restless Legs Syndrome

The aims of the trial are to assess the safety and the efficacy of SPM 962 following once-a-daily transdermal administration within a range of 2.25 to 6.75 mg/day in Japanese patients with restless legs syndrome (RLS) in a multi-center, open-label trial. The maximum treatment period is 53 weeks. The trial is an extension trial from the precedent 6-week, double-blind, randomized, placebo-controlled, parallel-group comparative trial(243-07-003). The trial is also for an exploratory investigation of incidence of augmentation, the most problematic complications in dopaminergic treatment.


Eligibility Criteria:
Inclusion Criteria:

* Subject completed the preceding trial 243-07-003 (NCT00666965)

Exclusion Criteria:

* Subject discontinued from the preceding trial 243-07-003 (NCT00666965)
* Subject had a serious adverse event which association with the investigational drug is not ruled out during trial 243-07-003
* Subject had a persistent serious adverse event at the baseline, which was observed and association with the investigational drug is ruled out during trial 243-07-003.
* Subject had persistent hallucination or delusion during trial 243-07-003.
* Subject had psychiatric conditions such as confusion, excitation, delirium, abnormal behaviour at the baseline.
* Subject had orthostatic hypotension or a systolic blood pressure (SBP) ≤ 100 mmHg and had a decrease of SBP from spine to standing position ≥ 30 mmHg at baseline.
* Subject had a history of epilepsy, convulsion etc. during trial 243-07-003.
* Subject developed serious ECG abnormality at the baseline.
* Subject had QTc-interval ≥ 500 msec at the baseline or subject had an increase of QTc-interval ≥ 60 msec from the baseline in the trial 243-07-003 and had a QTc-interval \> 470 msec in female or \> 450 msec in male at the baseline.
* Subject had a serum potassium level \< 3.5 mEq/L at the end of the taper period in trial 243-07-003.
* Subject had a total bilirubin ≥ 3.0 mg/dL or AST(GOT) or ALT(GPT) greater than 2.5 times of the upper limit of the reference range (or ≥ 100 IU/L) at the end of the period in trial 243-07-003.
* Subject had BUN ≥ 30 mg/dL or serum creatinine ≥ 2.0 mg/dl at the end of the taper period in trial 243-07-003.
* Subject who planned pregnancy during the trial.
* Subject was judged to be inappropriate for this trial by the investigator for the reasons other than above.