cyrilzakka/clinical-trials huggingface dataset:
BreEStim for Motor Recovery in Chronic Stroke With Severe Impairment (Pilot)

The overall goal is to investigate the effectiveness of a novel intervention - Breathing-controlled electrical stimulation (BreEStim) on finger flexor spasticity reduction and hand function improvement in chronic stroke with severe impairment.


Eligibility Criteria:
Inclusion criteria:

* has post stroke ≥ 6 months , medically stable;
* Unilateral, single stroke (no restriction on type (ischemic or hemorrhagic) or volume (large or small) of stroke);
* MAS score ≥ 1, i.e., detectable finger flexor hypertonia;

Exclusion criteria include:

* Patients with visual deficit/neglect; hearing or cognitive impairment;
* Patients with history of pulmonary disease (Asthma, chronic obstruction pulmonary disease, COPD);
* Patients that are currently adjusting tone alternating medications (e.g., baclofen), or
* Patients received botulinum toxin injection to the arm/fingers \<4 months, or phenol injections \< 2 years;
* Patients with a pacemaker;
* Women who are pregnant.
The Perceived Mismatch Between Dose Recommendations of PKI's and the Clinical Practice

A qualitative research study will be conducted using semi-structured interviews. The target population includes regulators involved in the registration of PKIs and healthcare professionals who use PKIs in clinical practice. Participants will be recruited until a rich understanding of the subject is reached.

* Background Protein kinase inhibitors (PKIs) are increasingly used as targeted therapy in the treatment of cancer. Currently, most PKIs are administered following the recommended dosage from the registered label based on pharmacokinetic and pharmacodynamic data, toxicity and tumor response as observed in clinical trials. Often, the recommended dose is selected based on the principle of the maximum tolerated dose (MTD). However due to pharmacokinetic and pharmacokinetic differences within patients, this registered flat starting dose often leads to toxicity. In addition, the fit and selected clinical trial patients are not always representative of the patients in clinical practice. This raises the question if the policy around dose development and recommendation is optimal. The objective of this study is therefore to increase patient safety, by exploring the perceptions of regulators and healthcare professionals on the perceived mismatch between the recommended dosage and the dose used in clinical practice for PKIs.
* Main research question What are the perceptions from regulators and healthcare professionals regarding the dosing recommendations for PKIs in clinical practice?
* Design (including population, confounders/outcomes) A qualitative research study will be conducted using semi-structured interviews. The target population includes regulators involved in the registration of PKIs and healthcare professionals who use PKIs in clinical practice. Participants will be recruited until a rich understanding of the subject is reached.
* Expected results This research aims to contribute to patient safety of PKIs in cancer treatment by exploring the opinions regarding the dosing recommendations at registration and their use in clinical practice from regulators and healthcare professionals. By gathering perceptions from important, preselected, stakeholders regarding dose regulations for PKIs, substantive knowledge will be gathered on the subject. This study will increase the knowledge base on the sufficiency of the standards for dose recommendations regarding PKIs and potentially aid in the generation of new policy recommendations.

Eligibility Criteria:
Inclusion Criteria:

- Regulators involved in the regulation of oncolytic products. Healthcare professionals who prescribe PKI's as a treatment for cancer in clinical practice (e.g. oncologists).

Exclusion Criteria:

* No exclusion criteria will be maintained.
Combined Vitrectomy and Femtosecond Laser-assisted Cataract Surgery

Based on the progress of cataract surgery, intraocular lens development, vitreoretinal surgery and anesthesia technology in recent years, the purpose of this study is to develop a new type of more accurate and minimally invasive combined surgery for cataract and fundus diseases, and to evaluate the advantages and value of the surgery as well as related complications, so as to minimize the surgical trauma and obtain faster visual function recovery and better patient comfort. To provide new solutions for the growing demand of eye health care.

To evaluate the efficacy and complications of a new type of minimally invasive femtosecond laser assisted-cataract surgery (FLACS) combined with pars plana vitrectomy (PPV) with two-step anesthesia in the treatment of various common fundus diseases such as rhegmatogenous retinal detachment (RRD), epiretinal membrane (ERM), macular hole (MH), and vitreous opacity, complicated with cataract. It is mainly aimed at the following kinds of common fundus diseases with cataract performing PPV and cataract removal combined with monofocal or premium intraocular lens (IOL) implantation： RRD complicated with cataract: FLACS +PPV + IOL+air; ERM complicated with cataract: FLACS +PPV+IOL + epiretinal membrane peeling + Ozurdex; MH complicated with cataract: FLACS + PPV+ IOL + internal limiting membrane peeling + air; Vitreous opacity with cataract: FLACS + PPV+ IOL.

Eligibility Criteria:
Inclusion Criteria: clinical diagnosis of following disease

* RRD with cataract
* ERM with cataract
* MH with cataract
* Vitreous opacity with cataract

Exclusion Criteria: patients with history of following condition

* intraocular surgery
* ocular trauma
* endophthalmitis
* uveitis
* glaucoma
Consultation Reasons in Family Medicine

The Tunisian society of family medicine STMF proposes to coordinate a national, observational, transversal and multicenter survey, at the consultations of general medicine / family medicine.

The Tunisian society of family medicine STMF proposes to coordinate a national, observational, transversal and multicenter survey carried out during two weeks, at the consultations of general medicine / family medicine. The main objective of the survey is to describe the reasons for consultation in general medicine / family medicine. The results obtained from this survey will make it possible to specify the specificities inherent to the reasons for consultations of Tunisians but especially to the peculiarities of the local health system (public and private). This survey will help us to assimilate our practices and harmonize them in order to optimize patient care and reposition family medicine in the patient's care path as well as the degree of adherence of practitioners to international recommendations in the care of the patient.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Informed consent, read and signed

Exclusion Criteria:

• Consent not obtained
Massed and Spaced HMP App Dosage Study

This study is a randomized controlled trial (RCT) of 2 weeks of the Healthy Minds Program (HMP) app Connection module in undergraduate students of a large, midwestern state university in the United States during the spring of 2021.

Participants will be recruited via email and/or flyers and will first complete an online screen. Eligible participants will complete baseline measures prior to attending an introductory session via web conferencing. During this session, participants will be randomly assigned to condition. Participants in both conditions will be asked to use the HMP app for 20 minutes per either, either split over two 10-minute session (Spaced condition) or in one 20-minute session (Massed condition). Participants will complete daily survey measures during the study and post-test measures after 2 weeks of intervention.

This study is primarily designed to assess feasibility and acceptability of 2 weeks of Connection training and assignment to dosage condition. Study team will investigate self-reported informal practice on the daily diary measure, measures of psychological distress (composite of depression, anxiety) and loneliness.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Undergraduate at UW-Madison
* Access to a smartphone or device capable of downloading HMP app
* PROMIS Depression or PROMIS Anxiety ≥55

Exclusion Criteria:

* Meditation retreat experience
* Regular meditation practice (i.e., weekly practice for \>1 year OR daily practice within previous 6 months)
* Previous practice under the instruction of a meditation teacher, other than in the context of an introductory course
* PROMIS Depression ≥70
Neuroprotective Study of Electroacupuncture Pretreatment in Patients Undergoing Cardiac Surgery

The purpose of this study is to evaluate the neuroprotective effect of electroacupuncture pretreatment in patients undergoing cardiac surgery as an preventive sequela in a randomized and controlled clinical trial. In addition, to investigate the role of inflammatory responses in the precess of the protection.

Heart valve replacement surgery has been proved to be an effective method in treating both regenerative and rheumatic valve disease. Current studies showed that cardiopulmonary bypass (CPB) and operation related cerebral injury is associated with worse patient morbidity and mortality after elective valve replacement surgery. Recently, Electroacupuncture (EA) pretreatment was proved to produced cerebral protective effects by mimicking ischemic preconditioning in animal models. However, the evidence that EA pretreatment can improve the clinical outcomes such as mortality and morbidity, is still lacking. The investigators perform a randomized controlled study to evaluate that EA pretreatment can improve the outcomes of cardiac surgery.

Purpose:

The purpose of this study is to examine if EA pretreatment can decrease the mortality and postoperative cerebrovascular complications in patients undergoing cardiac surgery. The effect will be assessed by mortality, scores of neurological defect, post operative cognitive dysfunction and stroke.

Methods:

Study patients will be randomized to cardiac surgery with EA pretreatment or conventional cardiac surgery in the Department of cardiovascular surgery, Xijing Hospital. EA pretreatment is performed at Baihui acupoint 30 min per day 5 consecutive days before the heart valve replacement surgery．Primary study outcome is cerebrovascular complications within 6 postoperative months. Secondary outcomes include the S-100B and NSE blood level measured during the first 72 hours of surgery follow-up, the several cytokines, including TNF-a, IL-8, IL-6, IL-10 and HMGB-1 blood level measured during the first 7 days of surgery follow-up, all cardiovascular haemodynamic parameters as measured by a pulmonary artery catheter, the length of intensive care unit (ICU) stay and length of postoperative hospital stay.

Eligibility Criteria:
This study enrolls a group of 40-65years patients who have heart valve disease who need valve replacement.

Inclusion Criteria:

* patients who have the indication for aortic or mitral valve replacement
* patients would like to accept the follow-up and sign the informed consent
* patients with heart function of NYHA I-III degree.

Exclusion Criteria:

* pregnant or nursing women
* comorbid with coronary artery disease
* patients with heart function of NYHA IV degree
* renal dysfunction with serum creatinine level\>or=2mg/dl(177umol/L)
* anticipated life span \< 12 months
* enrollment in other clinical trials at the same time not reaching the primary endpoint and probably interference the present trial.
Effects of Chronic Antihypertensive Therapy on Clinical Outcomes in Septic Shock

Retrospective two-cohort study to determine the effect of chronic antihypertensive therapy on new onset atrial fibrillation and clinical outcomes in septic shock.

This will be a retrospective two-cohort study to determine the effect of chronic antihypertensive therapy on new onset atrial fibrillation and clinical outcomes in septic shock. The two cohorts will be septic shock patients that were: 1) not on either a chronic β-blocker or angiotensin-converting-enzyme inhibitor (ACE inhibitor) or 2) on a chronic β-blocker, on chronic ACE-Inhibitor, or on both chronic β-blocker and ACE-inhibitor

Eligibility Criteria:
Inclusion Criteria:

* Adult patients 18 years of age or older
* Diagnosis of septic shock requiring vasopressor therapy (norepinephrine, epinephrine, phenylephrine, dopamine, or vasopressin)
* Admitted to the medical intensive care unit (MICU) at Rush University Medical Center (RUMC)
* Time frame: 01/01/2012 to 07/1/2016

Exclusion Criteria:

* Pregnant patients
* Transfer from outside hospital on vasopressors
* Admitted to MICU in cardiopulmonary arrest
* Prior arrest within 24 hours of admission to RUMC
Evaluation of Glycemic Index, Glycemic Load and Insulinemic Index of Spanish Breads

The present study was carried out to determine the glycaemic index (GI), glycaemic load (GL), insulinaemic index (InI), appetite ratings and postprandial plasma concentrations of gastrointestinal hormones related to the control of food intake after the ingestion of five types of commercially available selected Spanish breads. All volunteers took the breads and glucose in a crossover interventional study.

The most important cereal-derived nourishment is bread, a staple food which is the main source of daily carbohydrates. White bread is the one for which the most rapid decline has occurred, probably due to a popular belief that bread provokes weight gain, but more studies are needed to clarify the relationship between bread consumption and ponderal status in Spanish population.

A growing body of evidence supports a beneficial role for low-glycaemic index (GI) and glycaemic load (GL) diets in the prevention of life style-related diseases such as type-2 diabetes. Likewise, GI s widely used in the selection of foods suitable for glycaemic control, since low to moderate GI diets have been proposed for the prevention of type 2 diabetes, cardiovascular disease and age-related eye diseases. On the contrary, related to obesity, no associations between BMI, GI and GL have been reported in a Mediterranean population. Thus, investigations focuses on the implication of glycaemic response of different breads are of important application.

Many factors such as manufacturing bread conditions, starch structure, bread particle size and inclusion of different types of ingredients like whole-grains may influence glycaemic response and therefore may contribute to modify GI, GL and InI of breads. Comparing different French breads, GI value varied between 57 for the traditional baguette and 85 for the wholemeal loaf, while the traditional baguette exerted a significantly lowest postprandial insulin response and the lowest InI. However, to our best knowledge, neither the influence of different types of Spanish breads on GI, GL and InI nor the effects on appetite ratings and on the postprandial gastrointestinal hormone responses have been investigated.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 45 years old
* body mass index (BMI) between 18 and 30, normal and overweight
* healthy
* Accept to participate in the study

Exclusion Criteria:

* age below 18 and more than 45 years old
* BMI lower than 18 and more than 29
* smokers
* pregnancy or breastfeeding
* unusual fibre consumption
* glucose plasma levels higher than 110 mg/dl
* insulin plasma levels higher than 10 mU/ml
* blood pressure higher than 110 mmHg
* medication to treat blood pressure glucose or lipid metabolism
* suffering from metabolic or gastrointestinal syndrome
* genetic dyslipidemia or intake nutritional supplements in the last three months
Automated Telephone Outreach With Speech Recognition to Improve Diabetes Care: A Randomized Controlled Study

The purpose of this study is to evaluate the effectiveness of automated telephone outreach with speech recognition to improve diabetes care.

Randomly allocate a total of 1200 health plan members with diabetes to automated telephone outreach with speech recognition (ATO-SR; N = 600) or usual care (N = 600). The intervention is a series of three calls, using automated calls, originating from the health plan, using interactive speech recognition technology, spaced approximately 4-6 weeks apart, to encourage participants to fulfill the recommended testing (dilated eye examinations, glycated hemoglobin, LDL-cholesterol, microalbumin) that had not been performed received in the preceding year.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Diabetes, defined as either 1) filled a prescription for insulin or an oral hypoglycemic agent; or, 2) had two outpatient or one inpatient or two outpatients encounter claims with an ICD9-CM or CPT code indicating diabetes.
* Gap in a key diabetes management metric as evidenced by no claim for a dilated eye examination in the prior 15 months and no claim for one or more of the following tests: glycated hemoglobin, LDL-cholesterol, or microalbumin. (Individuals with evidence of having received ACE-inhibitors or angiotensin receptor blockers were considered to have had a microalbumin test.)

Exclusion Criteria:

* No primary care clinician in the data base
* Those who had previously asked the health plan to exclude them from research or quality improvement
* Women whose claim records contained diagnoses suggesting gestational diabetes
Feasibility Study: The Effect of Prazosin for Nighttime Symptoms of Civilian PTSD

Investigating the effect of prazosin for nighttime symptoms of civilian Posttraumatic Stress Disorder.

Each subject will receive prazosin and placebo trials, the order randomized. Day and nighttime symptoms will be monitored.

Eligibility Criteria:
Inclusion Criteria:

* must meet DSM-IV criterion for PTSD

Exclusion Criteria:

* Must not have untreated sleep apnea
Safety and Efficacy of Biphasic Remogliflozin Etabonate in the Treatment of Type 2 Diabetes

This is a dose-ranging study to evaluate the efficacy, safety and tolerability of a range of doses of a biphasic formulation of remogliflozin etabonate compared to placebo, administered over 12 weeks in subjects with type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Able to provide written informed consent
* Subject with clinical diagnosis of type 2 diabetes
* HbA1c 7.0 - 10.5% inclusive at Visit 1.

Exclusion Criteria:

* History of metabolic acidosis or ketoacidosis.
* Current active renal disease that is not related to hypertension or type 2 diabetes (e.g. non-diabetic glomerulonephritis, interstitial nephritis, symptomatic nephrolithiasis, etc.)
* Use of an investigational device or investigational drug within 30 days or 5 half-lives (whichever is longer) prior to Visit 1.
Concurrent Endostar, Paclitaxel/Carboplatin and Radiotherapy for Locally Advanced Non-small Cell Lung (RT0902)

Concomitant chemoradiotherapy is the standard treatment of locally advanced, non-resectable, non-small cell lung cancer (NSCLC). However, the optimal chemotherapy regimen is still controversial. The purpose of this study was to evaluate the efficacy and toxicity of a concomitant treatment using Endostar (Recombinant Human Endostatin), Paclitaxel/Carboplatin and radiotherapy for LA-NSCLC, and also assess its impact on patient Quality of Life (QoL) and progression-free survival (PFS).

Patients with non-resectable non-small Cell Lung Cancer will receive thoracic radiation therapy 60-66 Gy over 30-33 fractions and concurrent with Endostar 7.5 mg/m2 over 3 hours d1-14, Paclitaxel 50 mg/m2 weekly over 1 hour, Carboplatin AUC = 2 mg/mL/min over 30 min weekly. Followed by Endostar 7.5 mg/m2 d1-14,Paclitaxel 175 mg/m2 d1 and Carboplatin AUC = 5 mg/mL/min d1 every 3 weeks for 2 cycles as consolidation treatment.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven non-small cell lung cancer (squamous cell carcinoma, adenocarcinoma, large cell carcinoma and etc)
* Presence of measurable disease by RECIST
* stage IIIA or IIIB, non-resectable
* ECOG performance status 0-1
* No prior chemotherapy, radiation therapy to chest, immunotherapy, or biologic therapy .Patients must sign an informed consent indicating that they are aware of the .investigational nature of the study in keeping with the policy of the hospital.

Exclusion Criteria:

* Carcinoid tumor, small cell carcinoma of lung
* Patients with any distant metastasis
* History of another malignancy except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix
* Any other morbidity or situation with contraindication for radiotherapy (e.g. active infection, myocardial infarction preceding 6 months, symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmias, immunosuppressive treatment)
* Pregnant or lactating women, women who has not taken test of pregnancy (within 7 days before the first administration) and pregnant women
* Women and men of childbearing potential who have no willing of employing adequate contraception Tumor EGFR wild
Buprenorphine/Naloxone in the Treatment of Heroin Dependence - 14

The purpose of this study is the safety and efficacy of Buprenorphine/Naloxone in the treatment of opioid dependence. A compassionate use study.

The objective of this study is to provide follow-up compassionate use treatment and evaluate long term safety and efficacy of a buprenorphine/naloxone combination tablet for opiate dependence treatment for subjects who have completed Cooperative Study 1008 A and B.

Eligibility Criteria:
Inclusion Criteria:

- Completion of Cooperative Study 1008 A/B

Exclusion Criteria:

- Significant medical or psychiatric illness. Non-compliance with study procedures in the Cooperative Study 1008 A/B
The Protective Effect of Mask Wearing Against Respiratory Tract Infections

In this trial the researchers plan to recruit 4,000 volunteers to be randomly allocated either wearing face masks in public spaces where they are close to other people, or not wear face masks in such circumstances. For each participant the trial period is 2 weeks, after which they will be asked to complete a brief questionnaire which includes questions about whether they experienced the common cold, influenzas or COVID-19 symptoms during the trail period.

This study is a pragmatic, two-armed cluster randomized superiority trial including participants in Norway. Participants will be randomized to one of the following two arms: control group or medical masks in a 1:1 ratio. The primary outcome is self-reported respiratory infection.

The intervention is to ask participants in the intervention groups to wear face masks when close to others outside their home, e.g., in public spaces like shopping centres, and streets and on public transport. The control group will be asked not to wear face masks when close to others outside their home, e.g., in public spaces like shopping centres, and streets and on public transport. Participants will continue to use, or not use, face masks at work independent of which group they are allocated to.

The trial will be fully remote and without any personal interaction between investigators and participants.

The researchers aim to include about 4,000 participants to have a statistical power of 80% to detect a relative risk reduction of 30% for the primary outcome.

Eligibility Criteria:
Inclusion Criteria:

* Are at least 18 years of age
* Are willing to be randomized to wear, or not to wear, face masks outside their home when close to others for a 14-day period
* Provide informed consent

Exclusion Criteria:

* None