cyrilzakka/clinical-trials huggingface dataset:
Clinical Significance of Alveolar Recruitment Maneuver During Bariatric Surgery

The ventilation of the patient under general anesthesia is an old problem and extensively studied, especially in visceral surgery, higher risk of postoperative complications. Studies have recently shown the impact of a lung-protective ventilation in visceral surgery, however obese patients are often excluded, and alveolar recruitment maneuver has never been studied independently.

The investigators are conducting a randomized controlled prospective study to investigate the clinical value to achieve alveolar recruitment maneuver routinely in patients undergoing bariatric surgery.

The objective is to show the reduction in dyspnea, oxygen dependency: reflection of atelectasis and the incidence of postoperative complications.


Eligibility Criteria:
Inclusion Criteria:

* Patients surgery for bariatric surgery (sleeve, gastric bypass, gastric banding ablation)
* planned surgery,
* ASA 1-2-3,

Exclusion Criteria:

* Severe COPD
* Severe emphysema,
* Pneumothorax,
* Right sided heart failure,
* Severe heart failure
* Emergency surgery,
* ASA 4
Borderzone Sampling

On regular (diagnostic) MRI images brain tumors can show "contrast enhancement": uptake of an intravenously administered contrast agent can cause an enhancement pattern that is seen as a white area on a frequently used MRI protocol ("T1 weighted imaging"). High grade gliomas are a common brain tumor that share this enhancement pattern. The goal of surgery is to resect this contrast enhancing part without causing additional neurological damage. Intraoperative MRI (iMRI) is a helpful tool in achieving this goal, because it can provide updated images during resection and correct for deformations that occur in the brain during surgery. These deformations make preoperative images that are used for standard neuronavigation systems less reliable. However, due to manipulations during surgery, the contrast uptake during surgery may differ from contrast uptake in diagnostic MRI. This study aims to relate contrast enhancement on iMRI and tumor characteristics on tissue samples from the tumor. When the neurosurgeon considers the resection of the high grade glioma to be complete, an iMRI scan will be made, and tissue sampling will be performed on the borderzones of the tumor or tumor resection cavity respectively. This will provide insight in the relation between contrast enhancement on iMRI and the presence of tumor tissue. Such knowledge is important to improve effectiveness and safety of iMRI guided brain tumor resection.


Eligibility Criteria:
Inclusion Criteria:

* supratentorial brain tumor, on contrast enhanced MRI suspect for a high grade glioma
* indication for resection of the tumor
* age ≥ 18 years
* WHO Performance Scale ≤ 2
* ASA class ≤ 3
* good knowledge of the Dutch language
* informed consent

Exclusion Criteria:

* recurrent tumor
* multiple tumor localizations
* prior radiotherapy on the skull
* prior chemotherapy
Psychophysiological Effects of Music

This study employed a repeated measure between-subjects design. Two groups (i.e., depressed group and non-depressed group) of participants were recruited. Each participant experienced four stages: baseline, neutral control, sadness induction, and music intervention. The outcome variables were self-reported emotion and Heart Rate Variability features. Emotions were reported at the end of every stage. Electrocardiogram signals were recorded throughout the experiment.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-30 years
* Right-handed
* No recent illness or medication use
* No history of neurological or psychiatric disorders
* Normal or corrected-to-normal visual acuity (myopic participants wore glasses)
* Normal hearing

Exclusion Criteria:

* Incapable of giving written informed consent to this study
* Acute high suicide risk at baseline assessment
* Psychosis
Adherence to Pharmacological Antiepileptic Treatment in Adolescence

Epilepsy and its drug treatment affect fundamental aspects of an adolescent's lifestyle and can have major consequences on self-esteem and sense of identity. For many adolescents it is difficult to live with epilepsy and medication is difficult to accept; the side effects of medication, in particular even small changes in mental status and somatic appearance, are particularly feared and poorly tolerated. While it is true that drug-resistant epilepsies exist (about 30% of cases), it is also true that there exists a pseudo-resistance to drug treatment which is due to inadequate administration or poor adherence to treatment. It is estimated that 21 to 42% of patients on antiepileptic treatment don't adhere to the prescribed therapy. The literature emphasizes that non-adherence to treatment is a crucial problem for people with epilepsy, and that the adolescent population is particularly at risk. As with any chronic drug therapy, the therapeutic relationship plays an important role in the treatment of epilepsy. In adolescence, the communication that occurs within the therapeutic relationship takes on peculiar and specific aspects that go beyond the acquisition of anamnestic data and of what is usually reported explicitly in the interview. Communication must be centered on the adolescent's need for independence. Appropriate communication can make the adolescent feel more supported and can encourage him or her to gain self-awareness and control on decisions regarding his or her illness. For the physician, knowledge of the adolescent's point of view is indispensable in order to provide all the necessary information in an appropriate, understandable, and acceptable way, while at the same time acting as a mediator of communication.

The objective of this project is to describe and analyze adolescents' perception of antiepileptic treatment, their awareness of the disease and of the need for drug treatment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of epilepsy
* Age between 12 and 18 years
* On treatment with antiepileptic drugs for at least one year
* Able to understand and complete the questionnaire

Exclusion Criteria:

* Subjects with moderate to severe intellectual disability
TMS Treatment in Parkinson's Disease With Pain.

Transcranial magnetic stimulation (TMS) is a procedure that has been shown to improve pain in chronic sufferers. It is a well-tolerated procedure that can be performed on an outpatient basis. It uses a plastic covered coil that sends a magnetic pulse through the skull into the brain and by targeting particular areas in the brain it can be used to help modulate the perception of pain.

The study intends to use this technique to treat such a disabling symptom in patients who suffer from Parkinson's Disease (PD). Initially the aim is to study this technique in 48 patients who are suffering from pain and have PD. These patients would require an EEG before and after the stimulation. The stimulation would be performed over ten sessions and the patients would be assessed by a clinician using well recognized clinical tools.

It is anticipated that there will be a meaningful improvement in pain. It is also anticipated that TMS is a safe technique to use in patients with PD. The study will be used to help plan a future study that compares TMS with sham technique to prove whether TMS could be an option in the treatment of such a disabling condition.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with Parkinson's disease diagnosed as "clinically confirmed" or "very likely" according to the 2015 MDS clinical diagnostic criteria;
2. Age ≥ 18 Aged ≤ 80 years old;
3. PD patients with pain, exclude tumors, diabetes, osteoarthritis, rheumatoid rheumatism and other diseases, the use of analgesic drugs is not effective or insignificant.
4. After treatment with anti-Parkinson's disease drug regimen, anti-anxiety and depression, sleep drugs, analgesic drugs, etc. for ≥ 14 days, and the dosage is maintained during the treatment;
5. Ability to follow research plans and visit plans.

Exclusion Criteria:

1. Secondary Parkinson's syndrome caused by vascular factors, toxins, drugs, etc., or Parkinson's superposition syndrome.
2. PD patients with persistent head tremors.
3. Dementia, simple intelligent state check (mmse) ≤ 24 points.
4. Patients with suicidal tendencies and psychotic symptoms. 5, previously accepted dbs or damage surgery.

6. Contraindications for TMS (such as history of seizures, pregnant women, installation of pacemakers, metal inclusions in the body, intracranial hypertension, severe bleeding tendency, etc.)
Short Course Radiation Therapy in Palliative Treatment of Pelvic Cancer

Aim of the study is to assess efficacy of a short course radiation treatment in patients with symptomatic pelvic malignant lesions

standard treatment for pelvic lesions (300 cGy in 10 daily fractions of 300 cGy each) is compared with experimental treatment (2000 cGy in 4 fractions of 500 cGy twice a day) to demonstrate non-inferiority of this scheme

Eligibility Criteria:
Inclusion Criteria:

* symptomatic pelvic malignant lesions (primary solid tumors or metastases from solid tumor)
* age \> 18 years
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-3
* no changes in supportive care in the week before radiotherapy

Exclusion Criteria:

* pregnancy
* previous irradiation of the same region
Urinary Continence Index for Prediction of Urinary Incontinence in Older Women

This study will analyse existing data to establish a clinically useful index to predict those women who are more likely to become incontinent. This would create significant opportunities for focused prevention and early intervention strategies.


Eligibility Criteria:
Inclusion Criteria:

* Women

Exclusion Criteria:

* Men
Impact of Maternal Vitamin A or Beta-Carotene Supplementation on Maternal and Infant Mortality in Bangladesh

The purpose of this trial is to determine whether providing women with a weekly oral supplement of vitamin A, either preformed or as beta-carotene, at a dosage equivalent to a recommended intake from early pregnancy through three months postpartum, can reduce the risk of maternal mortality, fetal loss, or infant mortality.

Maternal mortality and vitamin A deficiency coexist in rural South Asia. In Nepal, weekly supplementation with vitamin A or beta-carotene during the child-bearing years reduced all-cause maternal mortality and, in night blind women, also infant mortality. The present trial is testing the efficacy of the same supplements from \~9 weeks' gestation to 12 weeks postpartum. The planned sample size is 68,000 pregnancies. It is being conducted in 19 rural unions, covering an area of \~750 sq km with a population of \~580,000 in Gaibandha and Southern Rangpur Districts in Northern Bangladesh. The study area was mapped as 596 "sectors" (unit of randomization), each comprising 200-275 households; \~135,000 houses were numerically addressed and, at the outset, 103,000 women were listed. Women are visited at home every 5 weeks by 596 trained female staff to detect pregnancy by a combination of menstrual history and urine testing. Newly married women are prospectively enlisted for pregnancy surveillance. Following informed consent urine-positive (pregnant) women detected during surveillance are enrolled to receive weekly a capsule containing 7000 retinol equivalents of preformed vitamin A, 42 mg of beta-carotene or placebo. Vital events are recorded weekly through 3 months postpartum. Trained interviewers conduct maternal nutritional and health and household socioeconomic assessments in the 1st trimester. At 3 months postpartum, interviewers assess both mother and infant for health and nutritional status, including apparent birth defects that are later physician-confirmed. An additional home health assessment occurs at 6 months post partum, and vital status is recorded for mother and infant at one year postpartum. A \~3% subsample of enrolled pregnant women participate in a substudy involving enhanced clinical, anthropometric, biochemical, body compositional, morbidity and interview-based assessment protocols in the 1st, 2nd and 3rd trimesters, and at 3 months post-partum. Reported maternal and infant deaths are verified and causes ascertained during "verbal autopsy" interviews with family members of the deceased.

Eligibility Criteria:
Inclusion Criteria:

* Married women of reproductive age
* First pregnancy during time period of trial

Exclusion Criteria:

* Premenarchial girls
* Married women with a previous pregnancy enrolled into the trial
* Previously married women who have moved into the study area
* Single women (never married, widowers)
* Women who are sterilized (or whose husbands are sterilized)
* Menopausal women
Left Ventricular MultiSpot Pacing for CRT (iSPOT)

The purpose of the iSPOT Study is to evaluate the contractility using positive left ventricular (LV) dP/dt max across LV pacing site(s) in patients indicated for cardiac resynchronization therapy (CRT).


Eligibility Criteria:
Inclusion Criteria:

* Subject is indicated for cardiac CRT or CRT-D device according to current applicable European Society of Cardiology (ESC)/American Heart Association (AHA) guidelines
* Subject has a left bundle branch block (LBBB) conduction pattern
* Subject is in stable sinus rhythm at the time of implant (no atrial arrhythmias lasting \> 30 seconds during the last 2 weeks prior to inclusion and no documented atrial fibrillation (AF) episodes allowed during the last 2 weeks prior to inclusion)
* Subject receives optimal heart failure oral medical therapy (ACE inhibitor and/or angiotensin receptor blockers (ARB) and Beta Blockers), and is on a stable medication scheme for at least 1 month prior to enrollment
* Subject (or the legal guardian) is willing to sign informed consent form
* Subject is 18 years or older or as specified minimal age per local law/regulation

Exclusion Criteria:

* Subject has permanent atrial fibrillation/ flutter or tachycardia
* Subject experienced recent myocardial infarction (MI), within 40 days prior to enrollment
* Subject underwent coronary artery bypass graft (CABG) or valve surgery, within 90 days prior to enrollment
* Subject is post heart transplantation, or is actively listed on the transplantation list
* Subject is implanted with a left ventricular assist device (LVAD)
* Subject is on chronic renal dialysis
* Subject has severe renal disease (defined as estimated Glomerular Filtration Rate (equation provided by Modification of Diet in Renal Disease study): (eGFR) \< 30 mL/min/1.73m2)
* Subject is on continuous or uninterrupted infusion (inotropic) therapy for heart failure (≥ 2 stable infusions per week)
* Subject has severe aortic stenosis (with a valve area of \<1.0 cm2 or significant valve disease expected to be operated within study period)
* Subject has complex and uncorrected congenital heart disease
* Subject has a mechanical heart valve
* Pregnant or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth control
* Subject is enrolled in one or more concurrent studies that would confound the results of this study
* Subject is already implanted with a device
Nurse-led Multidisciplinary Precision Care for Patients With Chronic Heart Failure

This study aimed to evaluate the feasibility and effectiveness of a nurse-led multidisciplinary precision care in early cardiac rehabilitation of patients with chronic heart failure, and further to promote the application of nurse-led multidisciplinary precision care.

Enrolled patients were randomly divided as 1:1 ratio to experimental group and control group, while experimental group received nurse-led multidisciplinary precision care and the control group received standard care according to guidelines. The primary and secondary outcomes were evaluated and analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Aged from 18 to 80 years;
* Conscious, with normal cognitive function and being communicable;
* NYHA heart function class II-IV;
* Patients met the diagnostic criteria of the clinical guidelines for the diagnosis and treatment of heart failure and were diagnosed with chronic heart failure;
* Informed consent was obtained.

Exclusion Criteria:

* Patients with congenital heart disease, cardiac shock, or persistent hypotension;
* Patients with severe liver and kidney dysfunction, moderate to severe anemia or coagulation disorders, and other serious systemic complications;
* Patients with a history of mental illness, a state of severe anxiety or depression, cognitive or communication impairments, and inability to communicate and respond to investigations;
* Patients have been involved in other research that would interfere with this study;
* Patients who declined cardiac rehabilitation and signed informed consent.
Multi-Center Study of New Medications to Treat Vaginal Infections

The purpose of this study is to evaluate the safety and efficacy of metronidazole gel in the treatment of vaginal infections.


Eligibility Criteria:
Inclusion Criteria:

* A clinical diagnosis of vaginal infection that is confirmed by laboratory testing and:
* Capable of providing written informed consent or assent
* Currently not menstruating and not anticipating menses during treatment
* If heterosexually active, subject must be post-menopausal for ≥ 1 year, surgically sterile, or practicing an acceptable form of birth control
* Negative pregnancy test
* Other criteria as identified in the protocol

Exclusion Criteria:

* Other infectious causes of vulvovaginitis
* Subject has recently used, or is expected to require the concomitant use of prohibited medications/products
* Nursing mother
* Use of any investigational drug within 30 days of enrollment
* History of hypersensitivity to any ingredient/component of the formulations
* Other criteria as identified in the protocol
Rivaroxaban for Treatment of Patients With Suspected or Confirmed Heparin-Induced Thrombocytopenia

Heparin is an anticoagulant (blood thinner) that is commonly used to treat patients with heart attacks and patients with blood clots in their legs or lungs (venous thrombosis). Some patients develop an allergic reaction to heparin, a condition called heparin-induced thrombocytopenia (HIT). HIT makes blood clot, which is the opposite of what heparin was designed to do. These blood clots can lead to heart attacks, strokes, limb amputations, and death. The objective of this 200 patient study is to determine if a new blood thinner called rivaroxaban (Xarelto) can be used to treat HIT. Rivaroxaban can be taken by mouth, does not require blood testing, and had a low risk of bleeding when it was used to treat blood clots in other clinical trials. If this study shows that rivaroxaban can be used to treat HIT, there will be two very important benefits. For patients with HIT, the benefit will be having a safe, and easy-to-use drug to protect them from developing further life or limb-threatening blood clots. For the Canadian health care system, the benefit will be having a drug that is much less expensive than the drugs currently used to treat HIT.

Consecutive adult patients with an intermediate or high clinical probability for HIT (according to the clinical prediction rule called the "4T's Score) will receive rivaroxaban 15 mg bid while awaiting confirmation or exclusion of HIT by the local laboratory assay. Patients who are confirmed to have HIT by the local laboratory assay will continue to receive rivaroxaban 15 mg bid until their platelet count ≥ 150 or until end of study (Day 30). At the time of platelet count recovery (typically 4-7 days), they will be transitioned to a maintenance dose of rivaroxaban (20 mg od) for a maximum of 30 days.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with 4T's Score greater than or equal to 4.

Exclusion Criteria:

* Require ongoing anticoagulant therapy for a mechanical heart valve.
* Severe renal insufficiency (CrCl\<30 ml/min)
* Hepatic disease (including Child-Pugh B and C) associated with coagulopathy and a clinically relevant bleeding risk
* Inability to take oral medications.
* Ongoing requirement for systemic treatment with azole-antimycotics (except fluconazole) or HIV-protease inhibitors or strong CYP3A4 inducers
* Clinically significant active bleeding or lesions at increased risk for bleeding within the last 6 months
* Platelet count less than 80 and an ongoing need for antiplatelet therapy may be excluded at the discretion of the investigator
* Pregnant or a woman of child-bearing potential not using an adequate birth control method
* Hypersensitivity to rivaroxaban or to any ingredient in the formulation.
Transcutaneous Electrical Acupoint Stimulation(TEAS) for Hypotension After Spinal Anesthesia in Parturients

The purpose of this study is to compare the effect of TEAS on hypotension after spinal anesthesia in patients undergoing cesarean section

Patients were randomly assigned to 3 groups, receiving TEAS , non-acupoint stimulation or no-stimulation after spinal anesthesia respectively. 1.4 ml of bupivacaine mixed with 0.2ml of 50% glucose was given for spinal anesthesia under lateral position. Then the patient was switched to supine position and the OR table was tilted to the left for 15 degree. The sensory loss level was assessed. The blood pressure and heart rate every 2min were recorded for 30min after spinal anesthesia. The adverse events and use of ephedrine adverse events were recorded as well.

Eligibility Criteria:
Inclusion Criteria:

* Age\>18yrs
* American Society of Anesthesiologists(ASA) status 1-2
* Scheduled for elective cesarean under spinal anesthesia
* Gestational age\>38weeks, singleton pregnancy
* Informed consented

Exclusion Criteria:

* Patients with pre-eclampsia or diabetes
* Patients with hypertension or cardiac dysfunction
* Disturbance of communication
* Placental abruption
Cardiac Tumors in Children

The purpose of this study is to define the natural history of untreated cardiac tumors, study the pathology of primary cardiac tumors, review the surgical treatment and results of primary cardiac tumors and to determine the prognosis for these tumors.

Primary cardiac tumors in children are extremely rare. Benign tumors are typically myxomas, lipomas, and rhabdomyomas, while malignant tumors are typically angiosarcomas and rhabdomyosarcomas. Due to the rarity of these tumors, it is difficult to gather meaningful information regarding their natural history, pathology and treatment.

The primary aims are to define the natural history of untreated cardiac tumors, study the pathology of primary cardiac tumors, review the surgical treatment and results of primary cardiac tumors and to determine the prognosis for these tumors. The secondary aims are to discover patterns and consistencies among primary cardiac tumors and to define the best treatment options for these patients. The study will be conducted through a retrospective chart review of about 70 patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients in the congenital surgery database
* Children who have been treated for a primary cardiac tumor
Study to Evaluate the Safety and Efficacy of Jaktinib in Adults With Alopecia Areata

This is a multi-center Phase 3 study to evaluate the safety and effectiveness of an investigational study drug (called Jaktinib) in adults (≥18 years and \<65 years) who have 50% or greater scalp hair loss. The study is placebo-controlled, meaning that some patients entering the study will not receive active study drug but will receive tablets with no active ingredients (a placebo). It is double-blinded, meaning that the Sponsor, the study doctors, the staff, and the patients will not know whether a patient is on active study drug (or the dose) or placebo.


Eligibility Criteria:
Inclusion Criteria:

* participants voluntarily sign the informed consent form (ICF);
* Age ≥ 18 years and \<65 years, either male or female;
* Clinical presentation compatible with alopecia areata with a current episode lasting not exceeding ≤8 years.
* At least 50% scalp hair loss.
* Willing to comply with the study visits and requirements of the study protocol.

Exclusion Criteria:

* participants has taken a JAK inhibitor prior to randomization;
* participants who are unsuitable to the trial, as identified by the investigator.