cyrilzakka/clinical-trials huggingface dataset:
Vaginal Cuff Closure Time Using Unidirectional Barbed Suture in Robotic Hysterectomy

This study is designed to determine if using the V-Loc Wound Closure System expedites operative time in robotic hysterectomy.

Currently both traditional continuous smooth suture and unidirectional barbed suture techniques are standard of care in robotic hysterectomy and the decision of which to use is at the discretion of the surgeon. By using unidirectional barbed suture in which no knot tying is required, wound closure time may be decreased resulting in decreased operative time. This study was created to compare vaginal cuff closure times using these two techniques.

Eligibility Criteria:
Inclusion Criteria:

* Women being scheduled to have a robotic hysterectomy for benign or malignant disease by the West Clinic Gynecology-Oncology Physicians
* Females age 18+

Exclusion Criteria:

* Patients receiving ongoing radiation therapy to the pelvis
Pilot Study to Assess Tolerability and Feasibility of Oral Sulfate Solution (SUPREP) in Hospitalized Patients

This study will test the efficacy, tolerability, and feasibility of an oral sulfate solution (SUPREP) for inpatient colonoscopy preparation, compared to the standard of care (GoLytely). The hypothesis is that SUPREP will be well tolerated and non-inferior to standard polyethylene glycol bowel preparation for colonoscopies in an inpatient setting. To test this, at least 124 subjects who are undergoing an inpatient colonoscopy will be randomized to receive either SUPREP or standard of care. The Boston Bowel Preparation Score will be collected as standard of care for both groups. Safety will be monitored from standard of care blood tests and ECG (when indicated). Subjects will be given a survey to assess how tolerable they found the procedure.

A non-inferiority design will be used to compare SUPREP to the standard of care polyethylene glycol preparation. Data analysis will be performed on Boston Bowel Preparation Score and rate of failure of preparation (measured as number of successful subsequent colonoscopies).


Eligibility Criteria:
Inclusion Criteria:

* Patients will be approached with consent for the study only if there is a clinical indication for pursuing an inpatient colonoscopy

Exclusion Criteria:

* Inability to consent (patient or POA)
Depiction of Delayed Enhancement in Patients With Documented Myocardial Infarction

The purpose of this study is to determine the dose of drug which is most effective in the delineation of dead heart muscle.

This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:

* At least 8 weeks post-documented myocardial infarction (heart attack)

Exclusion Criteria:

* History of radiation therapy to the chest
* Clinically unstable
* Any contraindication for MRI
Multiphasic Prehab Allo-HSCT

The purpose of this study is to implement a prehabilitation intervention to enhance recovery for people undergoing allogeneic stem cell transplant for hematologic malignancies. All participants in this study will receive a prehabilation intervention in addition to usual care (no change to their chemotherapy protocols or transplant) and several quality of life and fitness scores will be measured throughout the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, 18 years or older, undergoing an allo-HSCT for acute leukemia.
* Approval to engage in exercise as per screening by the CSEP or ACSM certified CEP and/or clinician
* Ability to provide written informed consent and understand study information.

Exclusion Criteria:

* Less than 18 years old
* Diagnosed with acute leukemia but not undergoing work-up for allo-HSCT
* Unable to read/communicate in English (i.e., unable to complete experimental procedures such as patient-reported outcomes).
* Neurological or musculoskeletal comorbidity inhibiting exercise.
* Diagnosed psychotic, addictive, or major cognitive disorders.
* Severe coronary artery disease (Canadian Cardiovascular Society class III or greater).
* Significant congestive heart failure (New York Heart Association class III or greater).
* Severe thrombocytopenia (platelets \<10) - ok if transfused platelets prior to exercise.
Safety and Efficacy Study to Treat Recurrent Grade 4 Malignant Brain Tumors

Immunotoxins can locate tumor cells and kill them without harming normal cells. Immunotoxin therapy may be effective in treating malignant glioma.


Eligibility Criteria:
Inclusion criteria:

The patients must fulfill all the following criteria:

* Previous histologically-confirmed diagnosis of primary GBM (glioma grade 4 at time of first diagnosis).
* Histologically-confirmed and MRI diagnosed recurrent or progressive GBM after previous resection (surgical or biopsy) and radiation therapy.
* Medically capable of undergoing the planned surgical gross total resection and the catheter placement.
* Age ≥ 18.
* Karnofsky Performance Status of ≥ 70%.
* Life expectancy of ≥ 3 months.
* Patients must already be taking or begin taking corticosteroids at a stable dose of 4 mg every 6 hours for at least 72 hours prior to catheter placement.
* Patients must be capable of taking, or already taking, anticonvulsant medication.
* Patients must have read, signed, and dated an informed consent according to ICH-GCP, the local regulatory requirement and the rules followed at each institution.

Exclusion Criteria:

Patients fulfilling any of the following criteria should not be enrolled in the study:

* Previous myelosuppressive chemotherapy within the past 4 weeks of the start of the infusion. Patients who have received more than two chemotherapy regimens (single therapy or combination therapy) are ineligible.
* Any form of brain radiation within 10 weeks of the start of the infusion.
* Previous gamma knife radiosurgery, stereotactic radiosurgery, and/or internal radiotherapy, unless the recurrence/progression is histologically confirmed (fine-needle biopsy).
* Prior intracavitary biologic response modifiers or monoclonal antibodies.
* Uncontrolled seizures.
* Bilateral or multifocal tumors.
* Evidence of cerebral uncal herniation.
* Midline brain shift on MRI scan of \> 0.5 cm prior to resection; patients with subfalcine herniation may be enrolled.
* Tumors involving the brainstem or cerebellum.
* Diffuse subependymal or CSF disease.
* Women who are pregnant or breast feeding. All women of child-bearing potential should be excluded unless they have a negative pregnancy test and are using adequate contraceptive measures or are surgically sterile. Post-menopausal women must be amenorrhoeic for at least 12 months to be considered of non-childbearing.
* Fertile males not practicing adequate contraception and whose female partners are not using adequate contraceptive protection.
* Prior or concurrent investigational treatment within 30 days of study entry.
* Active infection requiring treatment or having an unexplained febrile illness.
* Systemic diseases or other conditions which may be associated with unacceptable anesthetic/operative risk and/or which would not allow safe completion of this study protocol.
* Prior or concurrent malignancy (curatively treated carcinoma-in-situ or basal cell carcinoma or patients who have been disease free for at least 5 years are eligible).
Identifying At-Risk Patients and Predicting Deterioration of In-Patients Using Continuous Heart Rate, Respiratory Rate, and Movement Monitoring

Currently, all patients in the hospital are woken up throughout the night to check for vital signs, no matter how sick they are. The investigators are doing this study to determine whether skipping routine vital sign checks at night improves participant sleep quality and satisfaction without increasing the risk of adverse events.

The purpose of this study is:

1. To determine the correlation between subjective and objective sleep quality measures.
2. To compare the objective and subjective measures of sleep quality and satisfaction between the intervention group and the control group.
3. To compare the adverse event rates in the intervention group and the control group, defined as ICU transfer or cardiac arrest occurring within 24 hours of risk stratification.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Hospitalized on study unit

Exclusion Criteria:

* Inability to provide consent
* Non-English speaking
* Order for physical wound checks
* Order for cardiac telemetry monitoring
Melatonin for Delirium Prophylaxis

Delirium is a common complication of illness especially among the elderly with serious sequelae including increased mortality, morbidity and length of stay. This neuropsychiatric emergency has key features including acute onset, fluctuating level of consciousness, poor attention and cognitive deficits with a presentation which may include hallucinations and delusions.

A critical precipitating and maintaining feature of delirium is disrupted sleep. Melatonin is a widely available natural health product with evidence in normalizing circadian rhythms and sleep. There is also preliminary evidence that melatonin can be used to prevent the development of delirium in hospitalized patients. We hypothesize that daily administration of melatonin (1.5mg) in the evening, beginning at first admission to hospital and continuing for 14 days, will lead to decreased rates of delirium compared to placebo-treated comparison subjects.


Eligibility Criteria:
Inclusion Criteria:

* 65 years of age or greater
* Admitted to hospital under the care of the hospitalist service or sub-acute medicine wards.

Exclusion Criteria:

* those who are suspected to be delirious at the time of their initial presentation;
* those who are already taking melatonin prior to admission;
* those who are not expected to live more than 48 hours;
* those suffering severe dementia (as indicated by a score of 6-7 on the Global Deterioration Scale adapted by Dr. Doug Drummond from Reisberg et al. (Reisberg 1982);
* those who are unable to reliably take oral medications;
* those presenting with an intracranial bleed, seizure or acute stroke;
* those with a known allergy or adverse reaction to the study compounds;
* those who cannot be evaluated initially because of depressed level of consciousness or inability to communicate;
* those anticipated to require surgery early in their hospitalization.
A Study Protocol Comparing a Home Rehabilitation Program Versus e-Health Program in Low Back Pain

The aim of this randomized controlled trial is to evaluate the feasibility and effectiveness of providing an e-Health rehabilitation program through a web platform performing electroanalgesia and an exercise program following the McKenzie Method for patients with chronic low back pain in primary care, compared with the same home rehabilitation program but without the support of an electronic program.

A double blind clinical trial will be developed in a sample of 80 subjects with chronic low back pain. Patients will receive 3 weekly sessions of electroanalgesia and an exercise program for 8 weeks, for a total of 24 sessions. The aim is to analyze the effectiveness of a home rehabilitation program vs a web platform program on disability, pain, fear of movement, quality of life, resistance of the trunk flexors, lumbar mobility in flexion and muscular electrical activity.

Eligibility Criteria:
Inclusion Criteria:

* Low back pain ≥ 3 months.
* Age between 30 and 67 years old.
* Score ≥ 4 points on the Roland Morris Disability Questionnaire.
* Not being receiving physical therapy.

Exclusion Criteria:

* Presence of lumbar stenosis.
* Diagnosis of spondylolisthesis.
* Diagnosis of fibromyalgia.
* Treatment with corticosteroids or oral medication in recent weeks.
* History of spine surgery.
* Contraindication of analgesic electrical therapy.
* Have previously received a treatment of electrical analgesia or exercise.
* Central or peripheral nervous system disease.
* Agoraphobia
A Pilot Study of 566C80 for the Salvage Treatment of Toxoplasmic Encephalitis in Patients Infected With the Human Immunodeficiency Virus (HIV) Who Have Failed or Are Intolerant of Pyrimethamine-Sulfadiazine

To evaluate the safety and tolerance of atovaquone (566C80) in AIDS patients with central nervous system (CNS) toxoplasmosis. To evaluate the efficacy of 566C80 in the acute treatment and suppression of CNS toxoplasmosis in AIDS patients who fail or who cannot tolerate conventional therapy.


Eligibility Criteria:
Inclusion Criteria

Patients must have the following:

* Presumptive diagnosis of AIDS.
* Cerebral toxoplasmosis.
* Expected survival of at least four weeks without therapy.
* Willing and able to give informed consent.

Prior Medication:

Allowed:

* Pyrimethamine-sulfonamide.
* Clindamycin-sulfonamide.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Significant emotional disorder or psychosis.
* Evidence of significant malabsorption, ileus or significant emesis at entry which would inhibit drug absorption.
* Other known central nervous system lesions such as lymphoma, tuberculoma, cryptococcoma, active neurosyphilis. Unwilling or unable to take 566C80 with a meal, enteral supplements (eg:
* Ensure Plus) or pulverized form through a nasogastric tube.
* Active drug or alcohol abuse sufficient in the investigator's opinion to prevent compliance with the study regimen.

Concurrent Medication:

Excluded:

* Drugs with potential anti-toxoplasmosis activity including sulfone, sulfonamide, trimethoprim, pyrimethamine and clindamycin during the acute therapy phase of the trial.
* First three weeks of treatment:
* Retrovir (zidovudine) or any investigational agent including antiretroviral agents (eg:
* ddI,ddC).

Patients with the following are excluded:

* Significant emotional disorder or psychosis.
* Evidence of significant malabsorption, ileus or significant emesis at entry which would inhibit drug absorption.
* Other known central nervous system lesions such as lymphoma, tuberculoma, cryptococcoma, active neurosyphilis. Unwilling or unable to take 566C80 with a meal, enteral supplements (eg:
* Ensure Plus) or pulverized form through a nasogastric tube.
* Active drug or alcohol abuse sufficient in the investigator's opinion to prevent compliance with the study regimen.

Active drug or alcohol abuse sufficient in the investigator's opinion to prevent compliance with the study regimen.
A Study of Abatacept in Participants That Only Recently Started to Develop Rheumatoid Arthritis

This is a long-term study of Abatacept in participants that only recently started to develop Rheumatoid Arthritis, a chronic inflammatory disorder affecting mainly joints.


Eligibility Criteria:
Inclusion Criteria:

* Participants recently (within the last 24 months before enrollment) diagnosed with established moderate to severe active RA
* Participants naïve of abatacept and who, at their physician's discretion, are initiated with abatacept according the German label/SmPC (Summary of product characteristics)

Exclusion Criteria:

* Participants who are currently included in any interventional clinical trial in RA

Other protocol defined inclusion/exclusion criteria could apply
Fecal Recovery of the Probiotic Bacteria Lactobacillus Rhamnosus GG (LGG) and Bifidobacterium Animalis Subspecies Lactis BB-12 (BB-12) in Healthy Humans Following Daily Consumption of a Probiotic Supplement

The main hypothesis of this study is that there will be a significant increase of Lactobacillus rhamnosus GG (LGG) and Bifidobacterium lactis (BB-12) in the stool of healthy humans following daily consumption of a probiotic supplement containing these specific strains of probiotic bacteria.

To demonstrate recovery of live probiotic bacteria in the stool.

Eligibility Criteria:
Inclusion Criteria:

Are between 18-70 years of age. Have regular bowel movements. Are willing and able to attend study visits, undergo limited blood and urine testing, take the nutritional supplement according to the instructions provided.

Are willing to collect four stool specimens and bring them to the study site.

Exclusion Criteria:

Are unwilling to follow the dietary guidelines of the study. Are lactose-intolerant or have allergies to milk or wheat. Have had drug or alcohol problems within the previous year. Are or plan to become pregnant over the next 3 months.
To Compare The Efficacy Of N -Acetylcysteine and Standard Therapy Versus Standard Therapy In The Prevention Of Ischemic Hepatitis And Survival Post Upper GI Bleed

Patient presenting with upper GI bleed in ILBS (Institute of Liver and Biliary Sciences) emergency admitted to ICU (Intensive Care Unit) or shifted from ward to ICU (Intensive Care Unit) in view of upper GI bleed randomized to two groups

GROUP A : 110 Patients will receive standard care + NAC infusion for 72 hours

GROUP B : 110 Patients will receive standard care only

NAC will be given at following rate :

Initial loading of 150 mg/kg/hr over 1 hour Followed by 12.5mg/kg/hr for 4 hrs Then continuous infusion of 6.25 mg/kg for the remaining 67 hrs


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 and \< 75
* Cirrhotics with UGIE (Upper Gastrointestinal Endoscopy ) within last 24 hours.

Exclusion Criteria:

* Non cirrhotic
* Hepatocellular carcinoma
* Advanced cardiopulmonary disease
* Pregnancy
* Extrahepatic malignancy
* Patient on anticoagulation therapy
Study to Evaluate the Efficacy of Ruxolitinib 1.5% Cream in Adult Subjects with Discoid Lupus Erythematosus

This study is a single-blind, intraindividual study to evaluate the efficacy of ruxolitinib 1.5 % cream in adult subjects with discoid lupus erythematosus.

This study is being conducted to evaluate the efficacy, safety and tolerability of ruxolitinib 1.5 % cream in adult subjects with discoid lupus erythematosus.

Approximately 20 subjects with discoid lupus erythematosus will apply ruxolitinib 1.5% cream, twice daily on active lesions identified at Day 1 and any new lesions that appear, for 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subject 18 years of age or older at the time of consent.
* Confirmed DLE diagnosis.
* Subject has moderate to severe DLE, as defined by an overall CLA IGA score of 3 (moderate) or 4 (severe) at screening and Day 1.
* Female subject of childbearing potential must have a negative urine pregnancy test at screening and negative urine pregnancy test at Day 1.
* Subject has no known history of latent or active tuberculosis (TB) infection.
* Subject is willing to participate and is capable of giving informed consent. Note: Consent must be obtained prior to any study-related procedures.
* Subjects must be willing to comply with all study procedures and must be available for the duration of the study.

Exclusion Criteria:

* Female subject who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
* Subject has a history of skin disease or presence of skin condition that would interfere with the study assessments.
* Subject has unstable or fluctuating use of nicotine-containing products within 4 weeks prior to screening.
* Subject is known to have immune deficiency or is immunocompromised.
* Subject is ≥ 50 years old AND has a history of heart attack, other clinically significant heart problems, stroke, or blood clots.
* Subject has a known history of chronic infectious disease (e.g., hepatitis B, hepatitis C, or human immunodeficiency virus \[HIV\]).
* Subject is known to have hepatitis B or hepatitis C viral infection.
* Subject has used any topical medicated treatment that could affect DLE within 2 weeks prior to Day 1, including, but not limited to, topical corticosteroids, retinoids, calcineurin inhibitors, antimicrobials, and medical devices.
* Subject has received any marketed or investigational biological agent within 12 weeks or 5 half lives (whichever is longer) prior to Day 1, including but not limited to ustekinumab and rituximab.
* Subject is currently receiving a nonbiological investigational product or device or has received one within 4 weeks prior to Day 1.
* Subject has a known or suspected allergy to ruxolitinib.
* Subject has used ruxolitinib cream (OpzeluraTM).
* Subject has used JAK inhibitors for conditions other than DLE or other forms of lupus within 4 weeks prior to Day 1.
* Subject has a known history of clinically significant drug or alcohol abuse in the last year prior to Day 1.
Telematic Model Integrated in the Transversal Care of the Secondary Prevention of Patients With Stroke

In Spain, stroke is the leading cause of death in women and disability in adults, which is why it is currently one of the most important public health problems. It is known that the main cause of stroke is the lack of control of cardiovascular risk factors (CRF). Strategies have been diversified for patients with severe neurological involvement, while those without or with mild involvement, susceptible to repeat a stroke, have a very heterogeneous approach.

Objective: Design, implement and evaluate the effectiveness of the transversal telematic model of secondary prevention in patients who have suffered a stroke.

Methodology: Randomized clinical trial with a control group, open and multicentre. A total of 70 patients (35 per group) will be included who meet all the inclusion criteria and none of exclusion, attended by an acute stroke in the Hospital Verge de la Cinta de Tortosa. Variables: sociodemographic and clinical, FRC, stage of change, therapeutic compliance and CV. Outcome variables: impact of the stroke using the scale (SIS-16); control of CRF, new vascular events and mortality at 3, 6, 12, 18 and 24 months, integrable in the practice and computerized clinical history (HCI). Interventions: control and education for the patient's health to promote self-care and empowerment, and enhance pharmacological compliance. The telematic model has been developed through clinical practice guides of primary care and the most recent publications on the subject referenced. Export of data directly from the HCI.

Analysis of results with the SPSS 23.0 program, using regression and survival models.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients ≥18 years old, diagnosed of established ischemic stroke and / or TIA and attended by the HTVC neurology service, on discharge from home and with habitual residence in the Ebro Lands to be able to follow up .
* Informed consent of the signed study.

Exclusion Criteria:

* Patients suffering from other neurological injuries that interfere with the follow-up (established strokes, with or without MCA deviation, glioblastomas, etc.), life expectancy \<6 months, modified Rankin scale score (MRS) ≥3 and present language barrier and / or aphasia.