cyrilzakka/clinical-trials huggingface dataset:
Sucrose Breath Test to Determine Intestinal Permeability in IBS

Irritable Bowel Syndrome (IBS) is a growing clinical diagnosis affecting 10-20% of the US population. While current diagnostic criteria aids in correctly diagnosing IBS, the cause of the disease still remains unclear. It has been hypothesized that patients with IBS have alterations in the intestinal lining leading to release of toxic substances into the blood, commonly referred to as leaky gut. Current methods used to study leaky gut are both expensive and invasive. The investigators will test a new breath test to measure leaky gut in both IBS patients and subjects without IBS symptoms.

The sucrose breath test involves taking by mouth 20 grams of common sucrose. This amount of sucrose is about 4 packets of sugar that you would use to sweeten a beverage. If subjects meet eligibility criteria, a single breath test will be conducted on all subjects. The breath test involves collecting breath by exhaling through a straw into a special test tube. A breath sample is collected before administration of sucrose. After the baseline breath sample, a sugar solution with the 20 grams of sucrose is administered by mouth. Three additional breath samples are collected at 30, 60 and 90 minutes. After 90 minutes, the protocol is finished. We will be analyzing breath carbon dioxide for different levels of heavy carbon atoms (carbon-13)with an instrument called an isotope ratio mass spectrometer. Our study plan is to compare the amount of carbon-13 in breath between IBS patients and subjects without the condition. Up to 20 subjects per group will be studied.

Eligibility Criteria:
Inclusion Criteria:

* Male or females with clinical diagnosis of Irritable Bowel Syndrome by Rome III criteria (IBS Group) or healthy control.
* Must be 18 years old or greater.
* Women of child-bearing potential must have a negative pregnancy test.

Exclusion Criteria:

* Females who are lactating or pregnant.
* Subjects with allergy to sucrose.
* Subjects with other causes of abdominal pain or altered bowel habits such as IBD, celiac disease, pancreatitis or gastrointestinal bleeding.
* Subjects with a history of diabetes mellitus.
* Subjects with a recent febrile illness (5 days prior to study).
* Subjects that received an investigational drug or device within 30 days prior to study entry.
* Subjects that do not have the mental capacity to understand the protocol.
Nitroglycerin for Intra-arterial Chemotherapy in Pediatric Retinoblastoma.

The primary objective of the study is to evaluate the effect of intravenously infused nitroglycerin on the incidence of the cardio-respiratory side effects during the intra-arterial chemotherapy for retinoblastoma in pediatric patients.

The intra-arterial chemotherapy at the ophthalmic artery is an important treatment option for retinoblastoma. However, the cardio-respiratory side effects (sudden onset of bradycardia, hypotension, a severe decrease in the compliance of lung, hypoxia) occasionally occurs during catheter manipulation in the ophthalmic artery. One of the purported mechanisms of cardio-respiratory side effects is vagal activation from the activation of trigeminal ganglion by afferent signals from the ophthalmic artery. Additionally, the chemotherapy agent can cause intra-arterial retinal precipitates. Therefore, it is expected that the dilation of the retinal artery may reduce the cardio-respiratory side effects and intra-arterial retinal precipitates.

The hypothesis of this study is that the intravenously infused nitroglycerin will increase the compliance of the ophthalmic and retinal artery and decrease vagal stimulation and cardio-respiratory side effects during catheter manipulation and chemotherapy agent infusion. This is a single-center, double-blind, randomized, placebo-controlled study comparing the effect of intravenously infused nitroglycerin and saline on the incidence of the cardio-respiratory side effect in pediatric retinoblastoma patients undergoing intra-arterial chemotherapy. Prior to the procedure, each patient will be randomized into either the control-first arm, saline, or study-first arm, nitroglycerin.


Eligibility Criteria:
Inclusion Criteria:

* Retinoblastoma patients who need intra-arterial chemotherapy under general anesthesia
* Residual intra-arterial chemotherapy ≥ 2 times (cross-over design)

Exclusion Criteria:

* Respiratory disease causing a decrease in lung compliance
* Unstable vital sign, significant arrhythmia or hypotension, Shock
* Hypersensitivity or contraindication to nitroglycerin
* Increased intracranial pressure, Intracranial hemorrhage
* Recent use of PDE5 inhibitors (\<24 hours after sildenafil or vardenafil; \<48 hours after tadalafil)
Imaging Modalities for Pancreatic Collections

The purpose of this project is to provide appropriate administrative and technical supports for the warehousing and use of imaging data in pancreatic necrosis data for research purposes.

The aim of this study is to create a prospective registry of patients with pancreatic collections and their imaging studies (including CT, MRI, EUS, and direct endoscopic visualization) to compare these techniques, develop standardized methods for analyzing these imaging studies, and use this information to enhance management of patients with pancreatic collections. There is very limited published literature on these peripancreatic lesions that compares all three of these modalities and thus we aim to study it in detail.

Eligibility Criteria:
Inclusion Criteria:

* patients who are known to have a pancreatic fluid collection after an episode of acute pancreatitis
* age greater than 18 years

Exclusion Criteria:

* pregnant woman
* age \<18 years
* prisoners
* other institutionalized individuals
* patients who are decisionally impaired
Pilot Study Evaluate Efficacy of Grazoprevir + Elbasvir for 12 or 16 Weeks in Liver Transplant Recipients.

Pilot, single center, open-label study to evaluate the efficacy and tolerability of Grazoprevir and Elbasvir in HCV GT1 and 4 liver transplant recipients.30 liver transplant recipients with hepatitis C recurrence.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 78 year-old.
* Previous liver transplantation(more than 6 month).
* Genotype 1 and 4 infection.
* Hepatitis C recurrence defined by the presence of abnormal liver function test, positive HCV-RNA, histological signs of hepatitis C recurrence.
* Viral load ≥10000UI/mL.
* Immunosuppression with tacrolimus and/or mycophenolate (Prednisone use is allowed at low dose, ≤10 mg/d).
* Treatment naïve or treatment experienced (Peg-RBV or triple therapy).

Exclusion Criteria:

* Genotype 2, 3, 5 or 6 infection.
* Decompensated cirrhosis defined by the presence of actual or previous history of clinical decompensation including ascites, hepatic encephalopathy, variceal bleeding or spontaneous bacterial peritonitis, or a Child-Pugh B or C.
* Hepatocellular carcinoma after liver transplantation.
* Total bilirubin \> 3 mg/dL.
* Immunosuppression with cyclosporine or an mTOR inhibitor (everolimus or sirolimus).
* Severe extrahepatic diseases: cardiovascular, respiratory, cerebrovascular and poorly controlled diabetes.
* Platelets \< 75 x 109 cells/L.
* Neutrophil count \< 0.5 x 109 cells/L.
* Hemoglobin \< 9 g/dL.
* Albumin \< 3g/dL.
* HIV infection.
* Hepatitis B infection.
* Active intake of toxic amounts of alcohol or recreational drugs.
* Females who are pregnant, become to be pregnant or breastfeeding or males whose partners are pregnant, become to be pregnant or breastfeeding.
* Intake of disallowed medications including(but not limited to):

  1. Antibiotics: clarithromycin, erythromycin, telithromycin, nafcillin, rifampin
  2. Antifungals: itraconazole, ketoconazole, voriconazole
  3. Antihypertensives: nifedipine
  4. Anticonvulsants: carbamazepine, phenytoin, phenobarbital
  5. Bosentan
  6. Modafinil
  7. St.Jonh's Wort
  8. Immunosuppressants: cyclosporin, everolimus, sirolimus
  9. Diabetes agents: glibenclamide, glyburide
  10. Lipid lowering agents: gemfibrozil
  11. Eltrombopag
  12. Lapatinib
  13. HIV medications: efavirenz, etravirine, all ritonavir boosted and unboosted HIV protease inhibitors
  14. Statins: simvastatin, fluvastatin, rosuvastatin at doses greater than 10 mg/d, atorvastatin at doses greater than 10 mg/d.
Automated Telephone System to Improve Treatment Adherence in People With Depression

This study will determine the efficacy of a computerized telephone system called Telephone-Linked Care (TLC) in improving adherence to antidepressant medication regimens in people with depression.

The purpose of this study is to test the efficacy of a computerized telephone system called TLC (Telephone-Linked Care) in helping subjects adhere to their antidepressant medication regimens.

Eligibility Criteria:
Inclusion Criteria:

* A clinical diagnosis of major depressive disorder, dysthymic disorder, depressive disorder not otherwise specified, or any combination of the three
* Prescribed at least one antidepressant medication
* Access to a telephone with touch-tone service
* Speak and understand conversational English

Exclusion Criteria:

* Current significant alcohol or drug abuse
* Clinical diagnosis of bipolar disorder, schizoaffective disorder, or significant personality disorder
* Parkinson's disease, Huntington's disease, amyotrophic lateral sclerosis (ALS), or other neurodegenerative diseases
* Alzheimer's disease and other dementia
* Cancer, undergoing radiation therapy or chemotherapy
* Suffering from Renal disease or on dialysis
* Immunologic disorder (rheumatoid arthritis, systemic lupus erythematosus \[SLE\], etc.)
* HIV
* Terminal illness
* Homeless
* Legally blind
* Planning to leave the geographic area during the study period
NFAT-Dependent Cytokine Gene Expression for Immune Monitoring in Kidney Transplant Patients

The purpose of this study is to compare two different ways of monitoring the immune system to determine how to manage the doses of anti-rejection medications.

This is a single center randomized controlled trial investigating the efficacy and safety of adjusting calcineurin inhibitor (CNI) dosing based on Nuclear Factor of Activating T Cells (NFAT)-dependent cytokine gene expression as compared to standard of care adjustments based on trough level. Before any study-related evaluations are performed, the patient must give written informed consent. Once consent is obtained, a patient's eligibility to participate in the study will be assessed within 4 weeks of their 6 month management biopsy. Approximately 40 patients who meet inclusion criteria will be randomized at University of California, San Francisco (UCSF). Eligible patients include any patient maintained on triple therapy with tacrolimus, mycophenolate mofetil ,and prednisone who has had no prior rejection episodes and who has undergone a 6 month management kidney biopsy that shows no evidence of acute cellular rejection or antibody mediated rejection.

Eligibility Criteria:
Inclusion Criteria: Eligible patients include any patient maintained on triple therapy with tacrolimus, mycophenolate mofetil ,and prednisone who has had no prior rejection episodes and who has undergone a 6 month management kidney biopsy that shows no evidence of acute cellular rejection or antibody mediated rejection.

Exclusion Criteria: Any patient not maintained on triple therapy with tacrolimus, mycophenolate mofetil and steroids and/or who had evidence of rejection on 6- month management biopsy.
Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT)

The purpose of this randomized controlled trial is to understand how a cognitive-behavioral treatment (a form of psychological treatment) for depression changes the gut microbiome (micro-organisms that regulate the health of the gut), immune system, and the brain functioning in people living with HIV.

The overarching goal of this randomized controlled trial (RCT) is to identify the causal pathways that drive depressive symptoms among people with HIV (PWH). The scientific premise is that evidence-based depression treatment is an innovative, experimental probe to determine the neural substrates of depression and mechanistic relevance of microbiome-gut-brain (MGB) axis changes during and after Cognitive-Behavioral Therapy for Adherence and Depression (CBT-AD) on brain and behavioral function.

The proposed causal pathway is that reductions in depressive symptoms following the delivery of CBT-AD treatment will trigger a cascade of alterations in the MGB axis. Specifically, CBT-AD related decreases in depressive symptoms will induce alterations in gut dysbiosis, decrease microbial translocation, and improve soluble neuroactive markers of peripheral immune dysregulation. Our efforts to elucidate the immunologic mechanisms whereby CBT-AD could improve neurobehavioral outcomes will also focus on an established leukocyte signaling pathway, the Conserved Transcriptional Response to Adversity (CTRA), which has been shown to be responsive to behavioral interventions and psychosocial factors outside of HIV.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or older
2. Speaks and reads English
3. Verified HIV+ status with antiretroviral medications bearing his/her name
4. Current diagnosis on Major Depressive Disorder (MDD) using a structured clinical interview (DIAMOND) or Hamilton Rating Scale for Depression scores of 7 or greater
5. If prescribed antidepressants, on a stable regimen and dose for at least 2 months
6. Suppressed HIV viral load (\< 200 copies/mL)
7. Able to complete Functional Magnetic Resonance Imaging (fMRI) scans (i.e., no claustrophobia, no metal implants, no pacemaker, and BMI \< 40)

Exclusion Criteria:

1. Unable to provide informed consent
2. Active, untreated major mental illness
3. Pregnancy at baseline
4. Received CBT for depression in the past 2 years
5. Otherwise eligible but does not complete baseline biospecimen collection and fMRI visit
Cannabis Use in Cancer Patients

The goal of this study is to determine the feasibility of a human observational study of orally administered cannabis use among cancer patients.

Tightly controlled experimental laboratory studies (e.g., clinical trials with randomization) using Cannabis products available in state-regulated markets are simply, at this point, not possible owing largely to federal law and the University requirements related to the Controlled Substances Act and Drug Free Schools and Communities Act. Because a traditional clinical trial design is not possible given the current federal status of Cannabis products, this investigator will use a patient-oriented, prospective observational design. Specifically, individuals who have already decided to try Cannabis for their cancer treatment-related symptoms will initiate use of an orally administered product they have selected. A research assistant will provide information on the range of edible cannabis products and basic information about their various cannabinoid profiles, approximate prices, and nearby locations where participants may choose to purchase their product. The participants will then purchase the product and decide how often and how much to use. This approach is consistent with federal law and supported by our preliminary and ongoing studies(1R01AT009541-01, 1R01DA044131-01, CDPHE2902, R01DA039707). Patients will take the product as they see fit, without any frequency or dosing instructions from study staff, for two weeks, at which time they will be scheduled for an acute administration session (Ta1-Tc1) so that we may examine the acute effects of the product. The final follow-up will be one month later via an online survey sent directly to the participant via email.

Eligibility Criteria:
Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Provision to sign and date the consent form.
2. Stated willingness to comply with all study procedures and be available for the duration of the study.
3. Be a female or male aged at least 21 years.
4. Have a diagnosis of any solid tumor type who has or is undergoing either curative or palliative treatment
5. Have intent or interest to use cannabis to treat their symptoms.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Report of other non-prescription drug use, such as cocaine, heroin, methamphetamine in the past 60 days
2. Actively seeking or in treatment for any substance use disorder
3. Acute illness other than cancer that could affect cognition or compliance per the decision of the study M.D.
4. Premenopausal females who are pregnant or trying to become pregnant. Note that pregnancy testing will not be required.
5. A Telephone Interview for Cognitive Status (TICS) score indicating moderate or severe cognitive impairment at screening
Effect of California Tri-pull Taping Method on Shoulder Subluxation, Pain, Active Range of Motion and Upper Limb Functional Recovery After Stroke - A Pre Test Post Test Design

This study was conducted to check the effect of California tri-pull taping method on post stroke shoulder subluxation, prior to conduct a large randomized clinical trial this study was conducted, and the result of the study was promising for the treatment of shoulder subluxation.

Intervention was given by the lead researcher who was trained for the taping techniques.

Prior to give taping method participants who have hair around the shoulder was instructed to remove hair. Two types of tape was used, a self-adhesive 1.5" cotton undercover tape (VPK, Chennai) and a 1" rigid strapping tape (VPK, Chennai). To approximate the humeral head into the glenoid cavity participants were instructed to place their affected arm on a wooden table. Three piece of tape was used, firstly the investigators applied cotton undercover pre tape and then the investigators applied the rigid post tape on it. First piece (middle) of tape was applied from 1.5 inches below the deltoid tuberosity up to 2 inches above the glenoid cavity. Second piece (posterior) was applied from 1.5 inches below the deltoid tuberosity upto the 1.5 inches above the mid spine of scapula. Third piece (anterior) was applied from the 1.5 inches below the deltoid tuberosity upto the 1.5 inches above the clavicle. (Figure-1). The tape was removed and new tape applied every Monday, Wednesday, and Friday and remained on the patient for 6 consecutive weeks.

All the participants were received standardized conventional neuro rehabilitation programme. The conventional neuro rehabilitation treatment includes, active, and passive range of motion exercise, bilateral activation of pectoralis major, activation of lattisimus dorsi, activation of the retractors, weight bearing exercise of upper extremity, activation of supraspinatus, reaching activities, grasping, holding and release, and ADL activities. Every participant was received conventional neuro rehabilitation for 45 minutes and 5 days a week.

Eligibility Criteria:
Inclusion Criteria:

1. Acute stroke
2. A minimum of 5 mm (0.2 in.) shoulder subluxation in the involved upper extremity.
3. MMSE score ˃ 23.
4. Age (35-70 yrs.) and of either sex.

Exclusion Criteria:

1. MMSE score ˂23.
2. Other musculoskeletal disorder of the affected upper extremity.
3. History of trauma to the affected upper extremity.
4. Hyper or hypo sensitivity disorders.
5. Any skin allergy.
6. Individual affected from neurological disorder other than stroke.
7. Un-cooperative patients.
8. Individuals with psychosomatic disorder.
Intramyocardial Haemorrhage in Patients With Primary STEMI

The purpose of the study is to assess the frequency and intensity of intramyocardial haemorrhage in patients with primary STEMI and different reperfusion strategies.

The study non-randomized, opened, controlled. In half of patients despite on carried in-time reperfusion therapy intramyocardial haemorrhage determined after a long-term period of severe ischemia. Earlier, definition of intramyocardial haemorrhage was possible only by autopsy. Nowaday, cardiac contrast MRI is the best diagnostic method, which allows to assess the regional and global function of the LV, structural changes in myocardial tissue and also in T2 mode it became assessable to reveal intramyocardial haemorrhage.

Taking into account the results of previous researches, it can be concluded that the intramyocardial haemorrhage was determined in half of patients with primary PCI \[1\]. An influence of fibrinolytic therapy to the intramyocardial haemorrhage was conducted in small group of patients in one trial, and therefore further data will be actual and useful \[2\].

It is planned to study 60 patients with primary STEMI using standard therapy. The patients will be divided into 2 groups. Patients of the 1st group will be treated by pharmaco-invasive strategy. The 2nd group will be treated by primary PCI. Patients in all groups after reperfusion strategies will be conducted cardiac contrast MRI for detection intramyocardial haemorrhage within 2 days onset. At day 7 and through 3 months, the clinical condition of the patients will be assessed and cardiac ultrasound will be performed for the evaluation of myocardial contractile function and 2D global longitudinal strain. Also, the incidence rate of secondary endpoints will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years at time of randomization (18 years and older);
* Acute myocardial infarction;
* Reperfusion of the infarct-related coronary artery in terms within 12 h of symptom onset;
* Written the informed consent to participate in research;

Exclusion Criteria:

* Inability to obtain informed consent;
* Patients previously undergone endovascular / surgical revascularization of coronary artery;
* Severe comorbidity;
* History of myocardial infarction;
* History of intracranial haemorrhage;
* Pulmonary edema, cardiogenic shock;
* Creatinine clearance \<30 mL/min or dialysis;
* Unable to undergo or contra-indications for MRI;
* Allergy for contrast agent;
* Indication or use of oral anticoagulant therapy;
* Major bleedind;
* Atrio-ventricular block II and III degree;
* Active gastroduodenal ulcer;
* Aortic dissection;
* Acute psychotic disorders