cyrilzakka/clinical-trials huggingface dataset:
tDCS Combined With Constraint Induced Movement Therapy and Role of GABA Activity in Stroke Recovery

The aim of this study is to determine whether noninvasive brain stimulation in form of active transcranial direct current stimulation (tDCS) combined with constraint induced movement therapy (CIMT) offers an additional benefit as compared with sham tDCS combined with CIMT in patients with stroke. Furthermore the purpose is to highlight changes in GABA activity more than 3 months after stroke and its importance for effect of tDCS and CIMT combined with tDCS.


Eligibility Criteria:
Inclusion Criteria:

* stroke onset \>3 months prior to study enrollment
* subject has at least 10 degrees mobility over wrist, thumb and fingers on the affected side
* subject can move, stand up and stand firmly with constrained healthy hand
* subject can perform training 6 hours daily in 2 weeks
* subject is able to understand instructions and be able to cooperate

Exclusion Criteria:

* pregnancy
* contraindications to MRI of brain
* epilepsy, major psychiatric disease
* excessive pain that prevents training
* history of other diseases resulting decreased mobility of affected upper limb
Vascular Events In Surgery patIents cOhort evaluatioN - Cardiac Surgery

Worldwide over 2 million adults (\>30,000 Canadians) undergo heart surgery annually. Although heart surgery provides important survival benefits, it is associated with potential major complications such as death, stroke, and heart attack. There is promising evidence that measurement of heart injury markers after surgery will identify patients at risk of death or major complications.

This study will determine the current incidence of major complications in a representative sample of 15,000 contemporary adult patients undergoing heart surgery. Knowing the current burden of complications will inform clinicians, administrators, government and granting agencies about resources required to address the problem. This study will also establish the role of measuring heart injury markers to identify important heart injury after heart surgery and the proportion that would go undetected without routine heart injury marker monitoring. This information will facilitate further studies of timely interventions. In summary, the VISION Cardiac Surgery Study addresses fundamental questions that will have profound public health implications given the millions of adults worldwide who undergo heart surgery annually.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years.
2. Patients who have undergone cardiac surgery. This includes coronary artery bypass grafting and all open heart procedures such as valvular repairs/replacement.

Exclusion Criteria:

1. Previously enrolled in the VISION Cardiac Surgery Study.
2. Patients who have undergone an isolated pericardial window, pericardiectomy, permanent pacemaker or defibrillator implantation.
Study of GS-1427 in Participants With Moderately to Severely Active Ulcerative Colitis

The goal of this study is to learn if GS-1427 is effective in treating participants with moderate to severe ulcerative colitis. The study will compare participants in different treatment groups treated with GS-1427 with participants treated with placebo.

The primary objective of this study is to assess the efficacy of GS-1427, compared with placebo control, in achieving clinical response at Week 12.


Eligibility Criteria:
Key Inclusion Criteria:

* Individuals have Ulcerative Colitis (UC) with symptoms of at least 90 days duration before randomization, with the diagnosis confirmed by endoscopy and histology at any time prior to randomization. Documentation of endoscopy and histology consistent with the diagnosis of UC must be available in the source documents.
* Individuals have UC with minimum disease extent of 15 cm from the anal verge.
* Individuals have moderately to severely active UC as determined by endoscopy occurring during screening with a total modified Mayo Clinic Score (mMCS) of 5 to 9 points, including a centrally read endoscopic subscore of at least 2.
* Individuals have an inadequate response or loss of response or are intolerant to at least 1 of the following UC treatments: corticosteroids, immunomodulators, or advanced therapy.
* Individuals have an inadequate response or loss of response or are intolerant to \< 3 AT mechanisms of action for UC (use of 2 or more AT with the same mechanism of action, eg, 2 TNF-α inhibitors, counts as 1 mechanism of action)

Key Exclusion Criteria:

* Have a current diagnosis of Crohn's Disease (CD) or clinical findings suggestive of CD, diagnosis of indeterminate colitis due to etiologies such as an enteric pathogen, or lymphocytic or collagenous colitis.
* Have a current diagnosis of toxic megacolon, symptomatic colonic stricture, acute severe colitis, fulminant colitis, or abdominal abscess at screening or randomization.
* Have any history of exposure to vedolizumab or other integrin antagonists
* Requirement for ongoing therapy with or use of any prohibited medication as specified in the protocol

Note: Other protocol defined Inclusion/Exclusion criteria may apply
Adapting Cognitive Behavioral Therapy (CBT) for Chinese Americans

The goals of this study were to a) test whether cognitive behavioral therapy (CBT) is effective in treating depressed Chinese Americans, b) to develop and test the effectiveness of culturally adapt CBT, and c) to test the differential outcomes of the two treatments.

It is now known that ethnic minorities are less likely to receive quality health services and evidence worse treatment outcomes when compared with other groups (IOM, 1999; USDHHS, 2001). Moreover, there continues to be a shortage of systematic investigations examining the efficacy of evidence-based treatments (EBTs) with ethnic minorities, especially among Chinese Americans. Developing interventions that are both empirically grounded and that are culturally sensitive and compatible with Chinese culture is one promising strategy that may improve treatment outcomes for this understudied group. The goal of this study is to culturally adapt a cognitive-behavioral therapy manual for use with depressed Chinese American patients. This study will be among the first to develop a culturally adapted EBT for use with this ethnic group and will involve three study phases. Phase I of the study will focus on modifying and refining a CBT intervention protocol into a manualized treatment for Chinese Americans. Phase two involves a randomized controlled trial (RCT) comparing the effects of the culturally adapted CBT treatment manual with nonadapted CBT. Phase three will involve further refinement of the treatment manual, data analysis, and report writing. Patients will be recruited from an ethnic-specific mental health center that specializes in treating Asian American clientele to participate in the study. Patients will be randomly assigned to either the adapted CBT treatment or the nonadapted CBT treatment. Moreover, feedback from patients and therapists in both conditions will be used to further refine the new treatment manual, provide valuable information about salient issues in treating depressed Chinese Americans, and will provide initial estimates of treatment parameters that will be used in preparing a larger R01 proposal to further test the adapted intervention.

Eligibility Criteria:
Inclusion Criteria:

* depression, Chinese American

Exclusion Criteria:

* bipolar, psychotic disorder, primary substance abuse problem, severe medical conditions that induce depression
COVID-19 OUTBREAK AND SOLID ORGAN TRANSPLANTATION (SOT) : AN INTERNATIONAL WEB-BASED SURVEY

Background COVID-19 has brought into questioning the equitable distribution of resources. Solid Organ Transplants (SOT) are life-saving procedures. Rapid changes in the management of patients are occurring, with potential for inequity. Drawing on professionals across transplant specialities, we investigated resource distribution specifically for SOT to guide healthcare policies.

A multidisciplinary team developed a survey. The survey included demographic questions to contextualise respondents, questions on resource allocation for SOT. Multiple strategies were used to distribute the survey internationally. Descriptive, uni-multivariate ordinal regressions analysis were performed. Open comments were analysed using qualitative methods.


Eligibility Criteria:
Inclusion Criteria:

* transplant surgeons, referring doctors, transplant physicians, transplant coordinators, transplant ICU doctors, COVID-19 ICU, Infectious Disease Doctors, Pulmonologists, Internist, and Ethicists

Exclusion Criteria:

* not applicable
Medical Education in a Private Hospital

The purpose of this study is to assess patient and companion acceptability of medical education in a non-teaching private hospital


Eligibility Criteria:
Inclusion Criteria:

* Patients in the hospital ward and in the emergency waiting room
* Family members of patients admitted to the intensive care unit
Multicenter Study on Dialysis Modalities for End-stage Chronic Renal Failure Patients With Heparin-induced Thrombocytopenia

This research is based on the hypothesis that the Hydrolink®-NV dialysis membrane could allow the realization of quality dialysis with a significant reduction in the doses of Orgaran®, or even a total cessation of the anticoagulant, in patients with chronic renal failure. with heparin-induced thrombocytopenia.

Thus, this study aims to show that the use of this dialysis membrane without prior anticoagulation does not increase the risk of coagulation of the circuit and allows the realization of quality dialysis sessions.


Eligibility Criteria:
Inclusion Criteria:

* Patient, male or female, over 18 years of age.
* Patient on dialysis in a hemodialysis unit of the Ramsay Santé group.
* Patient with diagnosed heparin induced thrombocytopenia.
* Patient whose dialysis sessions benefit from extracorporeal circulation anticoagulation with Orgaran® or its equivalent (Arixtra® or Arganova®).
* Patient informed and having signed his written consent to participate in the study.
* Affiliated patient or beneficiary of a social security scheme.
* Woman of childbearing age with effective contraception, after verification of the absence of active pregnancy (negative pregnancy test)

Exclusion Criteria:

* Patient whose duration of dialysis is less than 1 month.
* Medically unstable or fragile patient.
* Patient participating in another clinical study.
* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of freedom by judicial or administrative decision.
* Pregnant, breastfeeding or parturient women.
* Patient hospitalized without consent.
* Patient with severe hepatic failure
Post-marketing Surveillance Study on the Safety and Effectiveness of Abiraterone Acetate Among Adult Filipino Male Patients With Advanced Metastatic Castration Resistant Prostate Cancer

The purpose of this study is to evaluate the safety and efficacy of abiraterone acetate in male Filipino patients with advanced metastatic castration resistant prostate cancer (CRPC) who have received prior chemotherapy containing a taxane.

This is an open-label (identity of assigned study drug will be known), observational study to evaluate the safety and efficacy of abiraterone acetate in male Filipino patients with advanced metastatic CRPC who have received prior chemotherapy containing a taxane. Approximately 50 patients will be enrolled. Abiraterone acetate will be administered according to the approved product insert with a low-dose glucocorticoid (prednisone or prednisolone). Patient assessments will be based on the accepted clinical practice in the Philippines. Patients will be monitored for 40 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
* Received at least 1 but not more than 2 cytotoxic chemotherapy regimens for metastatic castration resistant prostate cancer (CRPC) (at least 1 regimen must have contained a taxane such as docetaxel; if a chemotherapy regimen containing a taxane is used more than once, this will be considered as 1 regimen)
* Agrees to protocol-defined use of effective contraception
* Laboratory values within protocol -defined parameters

Exclusion Criteria:

* Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
* Abnormal liver function
* Uncontrolled hypertension (systolic blood pressure \>=160 mmHg or diastolic blood pressure \>=95 mmHg)
* Active or symptomatic viral hepatitis or chronic liver disease
* History of pituitary or adrenal dysfunction
* Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class III or IV heart disease or left ventricular ejection fraction of \<50% at baseline
* Known brain metastasis
* History of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of the study drug
* Any acute toxicities due to prior chemotherapy or radiotherapy that have not resolved to a NCI-CTCAE (Version 4.0) Grade of \<=1
* Prior systemic treatment with an azole drug (eg, fluconazole, itraconazole, ketoconazole) within 4 weeks of Cycle 1, Day 1
* Condition or situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with patient's participation in the study
* Participation in an investigational drug trial within 30 days prior to selection
* Known hypersensitivity to abiraterone acetate, or to any of the components in the formulation
Improving Medication Adherence Among People With Schizophrenia Through the Use of 2-way Pagers

This study will determine whether using a pager improves medication adherence in people with schizophrenia.

Schizophrenia is a life-long brain disorder affecting approximately 1 percent of Americans each year. Schizophrenia can be extremely disabling, causing people to hear voices, experience paranoia or hallucinations, and believe that others are controlling their thoughts. Many people with schizophrenia have difficulty with remembering their scheduled doctor's appointments and with taking their medication on time because of their mental illness. Many approved medications for schizophrenia must be taken several times a day and side effects such as drowsiness, dizziness, and even weight gain can deter a person from consistently taking their medication on time. Therefore, this study will determine whether a 2-way pager will help people with schizophrenia to remember their doctor's appointments and to take their medication on time.

Participants in this open-label study will first complete several written tests to assess skills such as memory, attention, and problem solving. Participants will also be asked questions regarding their current symptoms and medication regimen. Participants will then be randomly assigned to receive either treatment as usual or treatment as usual and a 2-way pager for 6 months. Participants who receive a 2-way pager will attend approximately four information sessions. During these sessions, participants will learn how to program the pager and use a specially designed medication bottle cap that will record the number of bottle openings and the date and time of each opening. At designated times, the pager will vibrate or beep, alerting participants to take their medication or attend a scheduled appointment. All participants will meet weekly with a staff member for the first month and then once a month for the remaining 5 months to complete several brief questionnaires on pager use, assess medication adherence, and discuss any symptoms experienced within the past week or month. Participants will be required to bring their medication to each meeting to ensure compliance.

Eligibility Criteria:
Inclusion Criteria:

* Meets DSM-IV criteria for schizophrenia or schizoaffective disorder
* Admitted to the Zucker Hillside Hospital for exacerbation of illness
* Speaks English

Exclusion Criteria:

* Presence of severe visual or motor impairments
* Mental retardation
* Neurologic disorder that may impact functioning such as seizures or vascular, neoplastic, traumatic, or infectious disorders affecting the brain
* Prescribed a psychotropic drug in depot form
* After hospital discharge, a living or treatment situation that includes dispensing of full medication regimen
Ultrasonographic Assessment of the Effect of CPB Acute Lung Injury

The study is designed to use the lung ultrasound to assess the effect of intermittent lung recruitment during cardiopulmonary bypass in cardiac surgeries on extra vascular lung water.

Significant respiratory dysfunction is a common problem after cardiac surgery, with an incidence of about 25%. the formation of atelectasis appears to be the primary factor responsible for increased intrapulmonary shunt after cardiac surgery with CPB. The investigators will use the lung ultrasound to evaluate the effects of intermittent recruitment of the lungs during CPB on extra vascular lung water (EVLW).

Objectives :

To evaluate the effect of intermittent lung recruitment during CPB in cardiac surgery on:

Lung ultrasound score (LUS),Oxygenation at different times postoperatively,Time for extubation and length of ICU stay

sixty patients aged from 18-60 years old, scheduled for elective cardiac surgery with CPB will be included in the study. Patients will be randomly allocated into one of two groups: Group A (n=30): will receive intermittent lung recruitment during CPB.Group B (n=30): control group.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged (18-60 years),
* elective valvular cardiac surgery with cardiopulmonary bypass (CPB).

Exclusion Criteria:

* • Emergency surgeries.

  * coronary artery bypass graft surgery
  * patients requiring re-exploration in the immediate postoperative period (within 2hours)
  * left Ventricular ejection fraction less than 40%
  * patients with preoperative congestive heart failure, cardiogenic shock , preoperative pulmonary edema
  * pre-existing severe chronic pulmonary dysfunction (defined as pulmonary disease requiring home oxygen therapy or causing shortness of breath after 1 to 2 flights of stairs)
  * Morbid obesity
  * Renally impaired patients with creatinine more than 2 mg/dl
An Open-Label Study of Once-Daily Oral Administration of Esomeprazole 40 mg in Patients With Symptoms of Gastroesophageal Reflux Disease (GERD)

The purpose of this study is to evaluate whether there is a difference in proportion of patients with resolution of heartburn and other symptoms related to gastroesophageal reflux disease (GERD) after four weeks of treatment with esomeprazole (NEXIUM®) in those subjects with Erosive Esophagitis (EE) and those without EE.


Eligibility Criteria:
Inclusion Criteria:

* Symptoms of GERD as defined in this protocol: Heartburn (severity of mild, moderate or severe) 2 or more times in the 7 days prior to the Screening visit (Visit 1) and, on average, at least 2 times per week over the past 3 months.
* Male or female, 18 to 70 years old, inclusive.
* Non-pregnant, non-lactating female patients. Female patients must be postmenopausal, surgically sterile, or using a medically acceptable form of birth control, as determined by the investigator. Females of childbearing potential must agree to continue using an acceptable form of birth control throughout the conduct of the study.
* Negative urine pregnancy test for females of childbearing potential.
* Willingness to adhere to all protocol requirements.

Exclusion Criteria:

* Previous enrollment in the present study.
* Significant clinical illness within 2 weeks prior to the first dose of study medication or a significant illness during the study.
* Use of a PPI, including PRILOSEC OTC®, within 21 days of Screening (Visit 1) or at anytime during the study (Visit 1 through Visit 4).
* Daily therapy with an H2 RA within 14 days of Screening (Visit 1): eg, ranitidine (ZANTAC®), cimetidine (TAGAMET®), nizatidine (AXID®), famotidine (PEPCID®) (occasional use; ie, less than daily, is permitted).
* Use of H2 RAs at any frequency are prohibited throughout the entire study (Visit 1 through Visit 4).
* A history of gastric or esophageal surgery (including, but not limited to, Nissen fundoplication and bariatric surgery), except for simple closure of a perforated ulcer or procedures that would not affect the study as determined by the Clinical Study Team physician at AstraZeneca.
* Clinically significant gastrointestinal (GI) bleeding (eg, melena, frank hematochezia) within 3 days of Screening (Visit 1) or noted at the time of baseline EGD.
* Non-acid related etiologies of esophagitis (eg, pill-induced, caustic ingestion or eosinophilic esophagitis).

Generalized bleeding disorders resulting from hemorrhagic diathesis (such as abnormalities in clotting factors or platelets).
The Perioperative Analgesic Efficiency of Bilateral Superficial Cervical Plexus Block in Patients With Thyroidectomy

To determine the postoperative analgesic efficiency of bilateral superficial plexus block, patients are divided into two groups. Study group received bilateral superficial plexus block, where control had none. Visual analog scale, opioid consumption and presence of nausea-vomiting are recorded.

Bilateral superficial cervical plexus block has successfully been demonstrated to provide an efficient analgesia in patients with thyroidectomy, parathyroidectomy, carotis end-arterectomy. The present study is aimed to investigate the intraoperative hemodynamic responses, anesthetic and analgesic consumption, and postoperative recovery quality of bilateral superficial cervical plexus block in patients with total thyroidectomy. After approval, patients enrolled in the study is invited to complete the Pain Catastrophizing Scale questionnaire. Patients are divided into two groups by computer-based randomization technique as control and study group. After standard monitorization, anesthesia induction and tracheal intubation, bilateral superficial cervical plexus block is performed to study group and no intervention to control group. At the end of the operation all patients received paracetamol 1 gr intravenous. In postoperative period, visual analog scale values, opioid consumption, presence of nausea-vomiting, anti-emetic usage or any other complications are recorded.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* Planned to undergo thyroidectomy
* An American Society of Anesthesiologists score of 1 or 2

Exclusion Criteria:

* Severe cardiovascular disease
* Psychiatric diseases
* Difficult intubation
* Rejected to participation
Place of Birth and Neonatal Health in Cases of Premature Birth Between 32 and 36 Weeks of Amenorrhoea

Moderate and late premature babies (32-36 weeks of amenorrhoea) account for around 6% of births, but 20% of neonatal deaths. These children also have an increased risk of neonatal morbidity and long-term neurodevelopmental sequelae compared with full-term newborns.

In the case of preterm birth, optimal antenatal, birth and postnatal management is necessary to prevent neonatal complications and mitigate longer-term consequences. However, we lack knowledge about the management of this at-risk population and the factors influencing their health.

This knowledge is needed in the current context of unfavourable trends in neonatal health. Over the last ten years, neonatal and infant mortality has stagnated in France, with France falling behind other European countries. According to the latest European report, France ranks 22nd out of 33 countries. The causes of this stagnation are not well known, but many hypotheses have been put forward, including sub-optimal organisation of care.


Eligibility Criteria:
Inclusion Criteria:

* All mothers and their newborn babies (live or stillborn) who had a delivery stay between 32 and 36 days of age recorded in the PMSI between 01/01/2015 and 31/12/2020.

Exclusion Criteria:

* Births in very small maternity units
* Births in hospitals without an obstetrics unit
* Births outside hospitals.