cyrilzakka/clinical-trials huggingface dataset:
ATTEND-Family-led Rehabilitation After Stroke in India

ATTEND Trial is based on early supported discharge- home based stroke rehabilitation model which proves to offer several advantages in low and mid income countries. The objectives of the pilot stude were to determine that with a randomized blinded outcome assessor, controlled trial, family- led caregiver- delivered home based rehabilitation is better than usual care for those with disabling stroke in India and the feasibility of this model.


Eligibility Criteria:
Inclusion Criteria:

* Adults (\>18 years)
* Recent (\<1 month) acute ischaemic/haemorrhagic/ undifferentiated stroke
* Residual disability (requiring help from another person for everyday activities)
* Expected to survive to discharge from hospital with a reasonable expectation of six month survival
* Able (or by proxy) to provide informed consent

Exclusion Criteria:

* Unable to identify a suitable family - nominated caregiver for training and subsequent delivery of care
* Those unwilling/unable to adhere to follow up.
Atazanavir for HIV Infected Individuals: An Early Access Program

The purpose of this clinical research study is to provide atazanavir to patients infected with human immunodeficiency virus (HIV) whose antiviral medications are no longer working to control HIV activity within the body and who are unable to create a new treatment regimen using other available anti-HIV drugs, because of either side effects or treatment failure previously taken. The safety of this treatment will also be studied.


Eligibility Criteria:
Key inclusion criteria:

* Patients eligible for inclusion into the EAP are those that are a virologic failure due to resistance, intolerance and/or adherence problems with current anti-HIV medications;
* OR have multiple toxicities or intolerance to their anti-HIV medication but are not a virologic failure;
* OR have severe elevated lipids in the blood (e.g., cholesterol, triglycerides) that do not respond to lipid-lowering medication.

Key exclusion Criteria:

* Restrictions apply regarding the use of atazanavir with specific medications which may have a potential to cause possible side effects when taken together.
* Patients will also be excluded for any of the following reasons: 1) pregnancy or breast feeding, 2) elevated liver enzymes, 3) significant cardiovascular disease, or 4) other restrictions as indicated in the protocol.
Exparel as a Nerve Block for Severe Hand Pain

The purpose of this study is to investigate whether the use of the study drug (Exparel) is safe and effective for treating circulation problems and pain in the hand or fingers.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) status I-IV

Exclusion Criteria:

* True Allergy, not sensitivity to: local anesthetics, midazolam, fentanyl, propofol, ketamine
* Previous surgery or significant trauma involving the radial or ulnar arteries (previous history of angiography and intravascular catheter placement are permitted)
* Pregnancy
* Severe hepatic impairment
* Evidence of infection at or near the proposed needle insertion site
* Any sensorimotor deficit of the ipsilateral upper extremity, whether acute or chronic as determined by the PI and/or designee
Biomarkers as Predictors of Chronic Heart Failure in Patients With Type 2 Diabetes

A cohort study on patients with type 2 diabetes to investigate possible biomarkers as predictors of chronic heart failure.

A cohort study on 500 patients with type 2 diabetes without known heart disease and age \> 50 years of age. On inclusion and on yearly basis, patients are evaluated by echocardiography, ECG, blood tests to examine NT-ProBNP, hs-CRP, troponin, kidney function and 6 minutes hall walk test.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* age \> 50 years

Exclusion Criteria:

* History of acute or chronic heart failure
* History of ischemic heart disease
Guidelines for Drug Therapy of Hypertension: Multi-Site Implementation

Clinical trial of implementation of clinical practice guidelines for managing hypertension in primary care clinics.

Background:

Hypertension, the most commonly reported medical problem in veterans, is a major risk factor for heart disease and stroke. Lowering blood pressure decreases the risk of these adverse clinical outcomes. Widely promoted evidence-based clinical practice guidelines set target blood pressures for adequate control, yet most hypertensives, including VA patients, do not meet the targets. Guidelines also call for use of specific drugs depending on the patient's pattern of comorbid characteristics; yet, clinicians often prescribe drugs that are not guideline-concordant.

Objectives:

The long term objective of this work is to contribute to the VA's ability to respond flexibly to rapidly evolving medical knowledge by establishing a system guidelines that can be used throughout the VA nationally for implementing multiple different clinical practice. In collaboration with Stanford Medical Informatics we developed an automated decision support system for hypertension management, known as ATHENA DSS built with EON technology for guideline-based decision support. ATHENA DSS incorporates hundreds of knowledge rules to operationalize guidelines for hypertension.

Methods:

ATHENA DSS combines patient information from VistA with an automated knowledge base of hypertension to generate patient-specific recommendations for management of hypertension that are displayed to primary care clinicians in pop-up windows in the VA�s Computerized Patient Record System (CPRS) when the record for appropriate patients is opened on the day of scheduled primary care clinic visits. The ATHENA DSS pop-up provides advice on adequacy of control of blood pressure and specific recommendations for drug therapy of hypertension, a visual display of the patient�s medication history and concurrent blood pressures, evidence supporting the main recommendations, and other information. We deployed the system at three VA medical centers--Durham, San Francisco, and Palo Alto�and conducted a clinician-randomized trial. We logged data on use of the system, monitored comments entered by clinicians, and conducted a questionnaire survey of clinicians. We planned analyses of impact on clinician prescribing and patient blood pressures. We planned preparation for dissemination of the system to additional VA medical centers.

Status:

Project work is ongoing at time of preparing this report. We recently received notice of funding for a VISN collaborative that will use the ATHENA DSS in five medical centers in VISN 1 (New England).

Eligibility Criteria:
Inclusion Criteria:

Primary care clinicians at participating study sites. That is physicians, nurse practitioners and physician assistants who have their own panel of patients to whom they provide direct patient care.

Exclusion Criteria:
Effects of OXY111A in Primary and Secondary Hepato-Pancreato-Biliary Neoplasm

The purpose of the study is to evaluate whether the novel anti-cancer drug OXY111A is safe and tolerated in patients with primary and secondary hepato-pancreato-biliary and gastrointestinal neoplasia as measured by exploring the maximum tolerated dose (MTD). At level of MTD, additional patients will be included aimed for assessing the efficacy profile in these neoplasia entities.

The IMP OXY111A counteracts hypoxia-induced tumor aggressiveness showing decreased tumor burden and increased survival in five different animal solid tumor models both applied as monotherapy and increased beneficial effects when followed by standard chemotherapy. The unique ability of the IMP counteract hypoxic tumor behaviour along with its non-toxic side effects tested both in animals and healthy volunteers is of outmost interest to explore in patients with solid tumors.

The study seeks primarily to determine the safety and tolerability of OXY111A in patients with primary and secondary hepato-pancreato-biliary and gastrointestinal neoplasia as measured by exploring the MTD in a conservative 3+3 dose escalation schedule. The window for DLT assessment is from first dose of study drug until first dose of standard of care chemotherapy or 10 days following completion of last dose of study drug (whichever is shorter in duration). Additionally, we will assess efficacy of OXY111A on decreasing tumor volume, metabolic activity, as well as circulatory tumor and angiogenic markers.

Eligibility Criteria:
Inclusion Criteria:

* Study Indication: patients diagnosed for non-resectable hepato-pancreato-biliary or gastrointestinal neoplasm
* Male and Female patients ≥ 18 years of age
* Signed Informed Consent after being informed
* Eastern Cooperative Oncology Group (ECOG) performance status score of ≥ 2 at study entry.
* A life-expectancy of \>3 months
* Adequate hematologic and renal function
* Use of effective contraception (per the institutional standard), if procreative potential exists
* Adequate recovery from recent surgery, chemotherapy, and radiation therapy. At least 28 days must have elapsed from major surgery, prior chemotherapy, prior treatment with an investigational agent or device, or prior radiation therapy (palliative radiation therapy is allowed)
* Accessible for treatment and follow-up. Patients enrolled in this trial must be treated at the participating center

Exclusion Criteria:

* Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product
* Women who are pregnant or breast feeding
Evaluation of Surgical Simulator for Practicing a Vascular Anastomosis

To determine if practicing an aorto-saphenous vein anastomosis on a low-fidelity surgical simulator allows trainees to produce a higher quality anastomosis in a shorter period of time, than a group that only learns by watching a video.

For many years, surgical training has been considered an apprenticeship, where the training experiences of residents, have been in real operative settings on living patients. We propose a study to demonstrate that - a low-fidelity simulation of an aorta-proximal vein graft anastomosis as in heart bypass surgery, using anatomical replicates (a special hydrogel polymer with properties similar to human vascular tissue) - is an effective, low-cost simulator for learning this surgical skill, and will provide the trainee with the ability to perform a better anastomosis in a shorter period of time.

Hypothesis: Practicing an aorto-saphenous vein anastomosis on a low-fidelity surgical simulator will advance the trainees' learning curve. This will allow trainees to produce a higher quality anastomosis in a shorter period of time, than a group that only learns by watching a video and will lead to enhanced patient safety.

Eligibility Criteria:
Inclusion Criteria:

* 1st year surgical resident at The University of Western Ontario
* Anastomosis naive - the subject must not have performed a human vascular anastomosis in the past (it is acceptable if they have observed one being performed in the past)

Exclusion Criteria:

* Completed a human vascular anastomosis as the primary operator/surgeon in the past
Changes in mRNA Expression Following Exposure to Naproxen

Using tissue samples obtained from a previous study, the effect of naproxen on the gene expression profiles of antral mucosal tissue will be assessed. We hypothesize that there will be distinct changes in the gene expression profiles of samples taken from individuals treated with naproxen versus samples taken from individuals treated with placebo.

We will use microarray technology to quantify the transcriptome-wide changes in gene expression in said-samples.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult between the ages of 18 and 75 inclusive
* Written informed consent prior to undergoing any study procedures
* A physical examination which reveals no clinically significant abnormalities
* Female subjects of childbearing potential must be taking an acceptable form of contraceptive

Exclusion Criteria:

* Any mucosal breaks within 2 cm of pyloric channel seen on baseline endoscopy
* Any GDU or \>5 gastroduodenal erosions at baseline endoscopy
* CXB, CPG, ASA, or NS-NSAID use within the prior 2 weeks
* Previous gastrointestinal ulcer
* Hypersensitivity or allergy to NSAIDs, ASA, CPG, CXB or other contraindication to taking treatments
* Baseline complaints of abdominal pain, nausea, and/or cramping
* Any acid blocking medication including antacids, H-2 receptor blocker within the prior 2 weeks, or PPI use within the prior 30 days
* Corticosteroids use within the prior 60 days
* Any documented bleeding tendency
* Has taken warfarin within the prior 60 days
* Three or greater alcoholic beverages daily
* History of cerebro-vascular event
Assessment of Pharmacokinetics and Bioavailability of Carbon-14 ([14C])-Labelled Oxytocin

The current study is designed as a phase I multiple dose study to evaluate the pharmacokinetics and bioavailability of \[14C\]-labelled oxytocin in healthy women.


Eligibility Criteria:
Inclusion Criteria:

* Non-smoking women of child bearing potential (WOCBP)
* Body mass index (BMI) between ≥ 18.0 and ≤ 30.0 kg/m2
* Subject must voluntarily sign a written informed consent agreement approved by the Independent Ethics Committee (IEC) after explanation of the nature and objectives of the study and before any study specific procedure
* Subject must be in good physical and mental health as judged by the Investigator based on evaluation of medical and gynecological history, physical examination, clinical laboratory, ECG, and vital signs data
* Subject is willing and able to comply with all conditions and requirements of the study

Exclusion Criteria:

* Lactation and/or pregnancy in the previous 6 months before screening, whichever is applicable
* Intention to become pregnant during the study or within 1 months after the follow up visit
* History of, or existing thromboembolic, cardiovascular or cerebrovascular disorder
* Treatment for any major psychiatric disorder in the previous 12 months or use of antidepressant medication before screening
* Any clinically significant abnormality following review of medical history, laboratory results and physical examination at screening as judged by the Investigator
* Conditions or disorders that might affect the absorption, distribution, metabolism or excretion of the study drugs
* Contraindications for the use of oxytocin
* Hypersensitivity to the active substances or to any of the excipients of the investigational product or reference therapy
* Present use or use within 30 days before the start of the study medication of one or more of the following medications: antihypertensive drugs, anti-coagulant therapy, medication that could affect myometrial contractility, sex steroids, prostaglandins and its analogues, inhalation anesthetics, vasoconstrictors/sympathomimetics and caudal anesthetics, vasopressin-like drugs
* Use of any prescribed or over-the-counter medication within 14 days before Day 1
* Administration of any other investigational drug within 3 months before Day 1 or participation in 3 or more clinical trials in the 10 months before Day 1
* Loss of more than 500 milliliters (mL) blood during the 3 months before Day 1, or intention to donate blood in the 3 months after completing the study
* Subjects with a positive test result for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) at screening
* Subjects with a history of alcohol or drug abuse or with a positive result at screening, for tests of alcohol intake or drugs of abuse
Use of SPECT-CT for Comparison of Dosimetry Methods in PSMA-targeted Radioligand Therapy (SPECTacular Study)

The SPECTacular study will enroll patients who are already undergoing a FDA approved PSMA-targeted Radioligand treatment cycle. During each treatment cycle, patients will receive 5 additional SPECT/CT scans to investigate the limits of agreement between dosimetry (absorbed radiation dose) approximation methods and dosimetry using the triexponential fitting method.

All patients with PSMA-positive tumor and/or Metastases of Prostate Cancer (PSMA-TMPC) who would be undergoing a PSMA-targeted Radioligand Therapy (PRLT) based on independent eligibility criteria for the same, will receive 6 serial SPECT-CT scans for every treatment cycle as a part of our study. The purpose of this investigation is to assess the limits of agreement of commonly employed dosimetry methods used to determine or approximate absorbed doses for organs and tumors compared to a dosimetry method using a triexponential fit requiring 6 post-injection SPECT-CT scans for all treatment cycles.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male, 18 years old or older
4. Histologically or pathologically confirmed prostate adenocarcinoma without predominant small cell component.
5. Patient is receiving PSMA-targeted Radioligand Therapy (PRLT) for treatment of PSMA-positive tumor and/or metastases of prostate cancer. Therapy may be FDA approved or investigational in nature under an approved clinical trial.
6. Ability to lay flat on scanner for duration of SPECT-CT imaging studies (1-2 hours)

Exclusion Criteria:

1. Assessment by the Investigator as unable or unwilling to comply with the requirements of the protocol.
2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≥ 2
3. All criteria which may preclude a PSMA-radioligand therapy using Lu-177 PSMA-617 or Lu-177 PSMA I\&T to be performed as per standardized guidelines and protocols laid down for these treatments and per decision by the treating physician.
State of Play of Non-tuberculous Mycobacteria in Alsace

Non-tuberculous mycobacteriosis (NTM) are infectious diseases caused by mycobacteria that are not part of the Tuberculosis complex. More than 190 species have been identified to date.

As an environmental reservoir, it most often affects the lungs, skin and soft tissues, lymph nodes, but it can affect all organs. Varying in virulence depending on the species, most infections do not cause illness.

There is currently no coordinated care pathway for this pathology in Alsace. The means necessary to set up such a structure requires knowing the importance of the disease.

The aim of the study is to determine the incidence of non-tuberculous mycobacterial infections in the ALSACE region, the proportion of cases in which the infection causes illness, and its evolution over time.

Eligibility Criteria:
Inclusion Criteria:

* Adult subject (≥ 18 years old)
* in whom a biological sample is culture positive for a non-tuberculous mycobacterium
* born in France and domiciled in Alsace (i.e. whose home postal code begins with 67 or 68)
* not opposing the reuse of its data for scientific research purposes

Exclusion Criteria:

* Subject having expressed opposition to participating in the study
* not domiciled in Alsace
* Born abroad
* Isolation of a mycobacterium from the Tuberculosis complex and Mycobacterium gordonae
Hemoglobin A1c and Immediate Postsurgical Complications Diabetes Type 2

The purpose of this study is to evaluate Hemoglobin A1c values previous to a surgery in patients with diabetes type II and the complication incidence in immediate post surgery.

The diabetes is a highly prevalent disease in patients who undergo an evaluation previous to a surgery. The most efficient glucose control, in patients with diabetes type II, reduces the risk of microvascular complications. Diabectic patients who underwent scheduled cardivacular or noncardiovascular surgeries show an increase rate of immediate and long-term complications. The most frequent complications are infections, cardiovascular events and death.

Intensive insulinisation during cardiovascular surgery reduces the risk of a new coronary event in the immediate post surgery. No studies have been found that show the evaluation of Hemoglobin A1c values before the surgery and the immediate post surgery complications.

A poor glycemic control has been associated to a large number of chronic complications like diabetic neuropathy, nephropathy, retinopathy and infection disease. The Hemoglobin A1c is used like a marker of the glycemic control in the last 120 days and has a correlation with the no enzyme glicosilation. This marker could have a relation with the complication after the programmed surgery.

This study will evaluate the incidence of complications in the immediate post operatory in patients with diabetes type II in relation to the hemoglobin A1c before the surgery. If the hemoglobin A1c has a correlation with the incidence of cardiovascular complications, this could mark a change in the therapeutic measures prior the programmed surgery.

Eligibility Criteria:
Inclusion Criteria

1. Patients older than 18 years with diagnosed of diabetes type 2
2. Programmed major surgery with expected hospitalization longer than 24 hours

Exclusion Criteria

1. Refusal to participate in the study or the informed consent process.
2. Programmed cardiac or coronary surgery
3. Technical complications inherent to surgical or anatomical abnormalities.
4. Pregnant women.
5. Active infection prior to performing surgery
ReNEW Clinic Cohort Study

This is an ongoing, prospective cohort study of children and young adults who are evaluated in the Reversing the Negative Effects of Weight on the Heart (ReNEW) Clinic at Johns Hopkins University.

Demographic and clinical data of patients who agree to participate are obtained via chart review and entered into a longitudinal clinic registry.


Eligibility Criteria:
Inclusion criteria:

* Children and young adults with overweight or obesity referred for evaluation of elevated blood pressure in the ReNEW Clinic at Johns Hopkins University are eligible.

Exclusion Criteria:

* Children who are wards of the state or who are non-English speaking without an in-person interpreter accompanying them to the clinic visit.
Persistent Postoperative Pain and Joint Stiffness After Total Knee Arthroplasty Performed for Osteoarthritis

Persistent pain and joint stiffness after surgery may interfere with recovery and adversely affect quality of life in up to 40% of patients who have undergone total knee arthroplasty. There is growing evidence that inflammation as well as other medical and psychological factors may be associated with osteoarthritis severity, progression, and associated pain severity. This study aims to identify clinical, biological, and psychological factors that contribute to and predict the development of these complications. Identification of such factors may allow us to target preventative measures to the patients at highest risk of persistent postoperative pain and joint stiffness.


Eligibility Criteria:
Inclusion Criteria:

* Elective primary unilateral total knee arthroplasty
* Osteoarthritis with radiologic evidence of "severe narrowing" and/or "bone on bone" in the affected joint
* Patients of surgeons who have agreed to participate in the study
* Age \> 18 years
* American Society of Anesthesiologists (ASA) Physical Status 1-3
* Regional anesthesia
* Epidural patient-controlled analgesia (PCA) for postoperative pain
* Adductor canal block for postoperative pain

Exclusion Criteria:

* Contraindication to regional anesthesia, NSAIDs, dexamethasone or acetaminophen
* Use of general anesthesia
* History of \>6 weeks of daily opioid use and/or any use of non-prescribed opioids
* Preoperative oral steroid use in the past 6 months
* Intra-articular steroid injection within one month of scheduled surgery in affected joint
* Non-English speakers
* Pre-existing diagnosis of rheumatic disease or autoimmune disease (e.g. rheumatoid arthritis, psoriatic arthritis, inflammatory bowel disease, multiple sclerosis, Type I diabetes)
* Peri-articular injections or infusions for postoperative pain
* Diagnosis of crystalline arthropathy
* Diagnosis of osteonecrosis
* Active infection or use of antibiotics
* Pregnant women