cyrilzakka/clinical-trials huggingface dataset:
A Randomized Trial Assessing the Effects of Inclisiran on Clinical Outcomes Among People With Cardiovascular Disease

ORION-4 is a research study coordinated by the University of Oxford and co-sponsored by The University of Oxford and Novartis (Protocol: CTSU_MDCO-PCS-17-01 (CKJX839B12301)). The study aims to find out if a new cholesterol-lowering injection (inclisiran) safely lowers the risk of heart attacks and strokes in people who have already had one of these conditions, or who have had an operation or procedure to treat blocked arteries.

The ORION-4 study aims to provide evidence about both the efficacy and safety of inclisiran. Inclisiran is a PCKS9 synthesis inhibitor which has been found to reduce LDL-cholesterol by about 50-60%. ORION-4 will investigate the effects of inclisiran on major adverse cardiovascular events.

The study is intended to be conducted at approximately 180 clinical sites in the UK and the USA. Approximately 15,000 participants aged 40 years or older for men, and 55 years or older for women, with pre-existing atherosclerotic cardiovascular disease will be randomized between inclisiran sodium 300 mg and matching placebo (given by subcutaneous injection on the day of randomization, at 3 months and then every 6-months) in a 1:1 ratio for a planned median duration of about 5 years.

Eligibility Criteria:
Inclusion Criteria

History or evidence of at least one of the following:

* Prior MI; or
* Prior ischemic stroke; or
* Peripheral artery disease as evident by prior lower extremity artery revascularization or aortic aneurysm repair.

Minimum age is 40 years for men and 55 years for women

Exclusion Criteria

None of the following must be satisfied (based on self-reported medical history):

* Acute coronary syndrome or stroke less than 4 weeks before the Screening visit or during the Run-in period;
* Coronary revascularization procedure planned within the next 6 months;
* Known chronic liver disease;
* Current or planned renal dialysis or transplantation;
* Previous exposure to inclisiran or participation in a randomized trial of inclisiran;
* Previous (within about 3 months), current or planned treatment with a monoclonal antibody targeting PCSK9, or with a drug known to be contra-indicated with inclisiran (none currently known);
* Known to be poorly compliant with clinic visits or prescribed medication;
* Medical history that might limit the individual's ability to take trial treatments for the duration of the study (e.g. severe respiratory disease; cancer or evidence of spread within approximately the last 5 years, other than non-melanoma skin cancer; or history of alcohol or substance misuse) or may put the individual at significant risk in the opinion of the investigator (or their authorised deputy) if he/she were to participate in the trial;
* Women of child-bearing potential, current pregnancy, or lactation;
* Current participation in a clinical trial with an unlicensed drug or device; or
* Staff personnel directly involved with the study and any family member of the investigational study staff.
Under-correction in Refractive Accommodative Esotropia

In most clinics, physicians reduce diopter of hyperopic glasses in older patients with accommodative esotropia. However, there are risks of decompensation in that practice. The authors are going to try measure the change of stability of eye alignment after reducing diopter of hyperopic glasses.

Inclusion criteria :

patients with accommodative esotropia

At initial visit(of study), the physician will reduce the diopter of hyperopic glasses as much as the patient can maintain their eye alignment (maximum amount 1.5D).

Outcome measure :

Follow-up examinations are scheduled at 1 week, 1 month, 3 months, and 6 months after the patients begin wearing under-corrected spectacles. At every visit, symptoms such as asthenopia, diplopia, or blurred vision will be documented and ocular examinations, including visual acuity and ocular alignment status for distance and near will be performed. Tests of fusion and stereoacuity will be performed at the 1-month, 3-month, and 6-month follow-up visits.

Eligibility Criteria:
Inclusion Criteria:

* patients with accommodative esotropia
* older than 24 months

Exclusion Criteria:

* unstable eye alignment
* older than 18 years
Indonesian Study of Vonoprazan Vs Esomeprazole in Erosive Esophagitis

The goal of this clinical trial is to compare drug vonoprazan vs esomeprazole effectiveness to relieve early symptoms in Erosive Esophagitis Patients. It will also learn about the safety of both modalities. The main questions it aims to answer are:

How does the effectiveness of Vonoprazan compare with Esomeprazole in improving early symptoms of erosive esophagitis patients in the Indonesian population?

Researchers will compare drug vonoprazan to a esomeprazole with a look-alike packaging to see their effect to reduce early symptoms of erosive esophagitis.

Participants will:

* Take drug vonoprazan 20mg or esomeprazole 40mg one time every day for 2 weeks
* Visit the clinic once every weeks for followup (Gastro Esophageal Reflux Disease-Quetionnaire measurement)
* Keep a diary of their adverse effect occurence and every variable data based on Gastro Esophageal Reflux Disease-Questionnaire.

Based on the calculation using the formula for comparing two population proportions, the minimum estimated sample size is 97 samples for each group. Considering a potential 10% drop-out rate, the estimated sample size increases to 108 samples per group. Therefore, the total minimum sample required for this study is 216 samples for both groups.

All the patients will screened using the Gastro Esophageal Reflux Disease-Quetionnaire (6 questions, 4 answer options, covering the last 7 days) and collected through RedCap. After that all eligible patients will undergo endoscopic examination that performed by gastroenterology specialists or trained internists.

Included patients who consume any Proton Pump Inhibiotr or Potassium-competitive acid blockers within 2 weeks prior to this study will undergo wash-out period for 2 weeks. Patients are monitored weekly during the wash-out period. Medication reminders are sent via instant messaging at least twice per week. Adverse Event will be monitored by research assistants in coordination with the patient's primary physician.

All the data will analyzed blindly with Chi-square or Fisher's exact test for categorical data and logistic regression for confounding factors. At the end of the study, the pharmacy team will reveal the group allocation.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged \>18 years with a GERD-Q score of 8.
* Diagnosed with erosive esophagitis by endoscopy. (Los Angeles Classification A-D)
* Patients are willing to undergo a series of therapeutic management.

Exclusion Criteria:

* Patients with a history of allergy to PCAB or PPI groups.
* Patients with gastric and/or duodenal ulcers.
* Patients with Helicobacter pylori infection.
* Patients with a history of significant systemic disease disorders affecting the esophagus and stomach.
* Patients with a history of malignant disease related to the esophagus and/or stomach.
* Patients with a history of esophageal and/or gastric surgery.
* Pregnant patients
Effects of Cerebral and Peripheral Electrical Stimulation on Conditioned Pain Modulation in Healthy Subjects.

The Neuromatrix pain model and new findings on pain chronification process point to a greater efficacy of treatments that address central and peripheral rather than only peripheral structures. Both cerebral and peripheral electrical stimulations can modulate brain areas involved in pain processing. However, their effects on pain modulation systems and clinical outcomes are lacking.

This study aims to investigate the efficacy of transcranial direct current stimulation (tDCS) and peripheral electrical stimulation (PES) alone as well tDCS combined with PES on pressure pain threshold and conditioned pain modulation in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

Healthy subjects without medical complaints.

Exclusion Criteria:

Concurrent medication likely to affect cognitive performance pregnancy or possible pregnancy history of drug or alcohol abuse or dependence recent head injury (in the last 3 months) history of seizure or stroke.
Comparison of a New Patient Warming System Using Polymer Conductive Warming With Forced Air Warming During Surgery

Two patient warming systems will be compared with 40 patients each in a convective warming group (BairHugger, Arizant) and in a conductive warming group (HotDog, Augustine Biomedical).

The patients will undergo small to medium trauma surgery and will be warmed with the randomized device - the hypothesis is, that the area under the standardized core temperature / time curve is significantly greater in the conductive warming group. Secondary outcome is the mean skin temperature / time area under the curve.

General study design We will study 200 patients (18-90 years) undergoing elective orthopedic surgery at the trauma surgery unit. The patients must have normal weight (20-30 BMI), the duration of surgery should last between 3 - 4 hours. There will be no other exclusion criteria (except severe peripheral arterial disease in the warmed extremity), as forced air patient warming is routinely used for all patients during this procedure.

The patients will be randomly assigned via a computer generated randomization list to treatment with either polymer or forced air warming. Anaesthesia and fluid management will be administered as desired by the anaesthesiologist.

Before warming four skin temperature probes will be attached to the upper arm, chest, abdomen and back of the patients to calculate mean body temperature. A probe (Mallinckrodt Anesthesiology Products, Inc., St. Louis, MO) will be introduced in the ear to measure core temperature. Afterwards, treatment with BairHugger or HotDog will be started.

The measurements will be recorded every five minutes until the end of surgery when intraoperative warming is stopped.

Differences between core temperatures will be analyzed both by using the summary measure of AUC (area under the curve) and by comparing the core-temperature at the end of surgery in the polymer and the forced air group with two-tailed, unpaired t tests if normally distributed and with a Wilcoxon test, if not normally distributed (distribution tested by K-S-test).

Results are expressed as means ± standard deviations if normally distributed, as median (IQ-Range) when not normally distributed.

Differences will be considered statistically significant when P \< 0.05. We consider a difference in core temperature at the end of surgery of 0.5°C as clinically important. Considering this difference as well as a known standard deviation of approximately 1.5°C we will have to study 40 patients in each arm of the study to achieve statistical significance using a power of 90% and a p-value of 0.05.

Eligibility Criteria:
Inclusion Criteria:

* The patients must have normal weight (20-30 BMI), the duration of surgery should last between 3 - 4 hours.
* There will be no other exclusion criteria , as forced air patient warming is routinely used for all patients during this procedure.

Exclusion Criteria:

* Severe peripheral artery disease in the warmed extremity
Project to Use Community Health Workers to Reduce Maternal Deaths

The purpose of this trial is to establish if several interventions will help women in rural Tanzania access health care services during pregnancy and at the time of delivery. The interventions include education about the importance of attending antenatal care visits with nurses and facility deliveries, a voucher for transport to access the health facility at the time of delivery, and supplies to be used either at the health facility, or on route if the women does not make it to the health facility.

In order to reduce the number of women dying in childbirth and to improve women's health in pregnancy, this trial is designed to assess if several interventions combined can increase the number of women delivering in health care facilities. The design of the study is "Multiple Baseline Design". Community health workers are trained to collect baseline data on women using mobile phones in one rural district in Tanzania. The district has four distinct divisions. After 6 months of baseline data in the district, one division will experience the interventions. The interventions are education about the importance of attending antenatal care visits with nurses and facility deliveries, a voucher for transport to access the health facility at the time of delivery, and birthing supplies to be used either at the health facility, or on route if the women does not make it to the health facility. The intervention will be begun in each of the other divisions in 3 month intervals (i.e. the second division starts to experience the interventions 3 months after the first, the third, 3 months after the second and the fourth 3 months after the third). The trial will continue for a total of 27 months including the baseline period.

Eligibility Criteria:
Inclusion Criteria:

1. Women must be pregnant.
2. Women must live in Rorya District, but not in Shirati Town.
3. Women must deliver in Rorya District .

Exclusion Criteria:

1. Women who live outside or deliver outside of Rorya District.
2. Women who deliver preterm, before they have exposure to all the interventions.
Internet-based Behavior Therapy for Adults With Tourette Syndrome

This study protocol outlines a parallel-group, randomized controlled trial (RCT) designed to evaluate the effectiveness of Internet-delivered behavior therapy (BT) based on exposure with response prevention (ERP) for adults with Tourette syndrome (TS) or chronic tic disorder (CTD). The primary aim is to evaluate the effects of Internet-delivered ERP-based BT on tic severity compared to a control condition offering general psychological support at week 11 counting from the treatment start. The primary outcome measure is the Yale Global Tic Severity Scale - Total Tic Severity subscale (YGTSS-TTS). Secondary outcomes include measures of tics-related impairment, work and social adjustment, rates of responders, self-rated tic severity, symptoms of depression, and quality of life. Long-term maintenance of results will be assessed at week 23 and 14 months after the treatment start. Participants will be recruited nationwide. The intervention group will receive 10 weeks of ERP-based therapy delivered through an online platform, with therapist support. The control group will receive psychoeducational content and general psychological support. Adherence to treatment, adverse events, and patient safety will be closely monitored throughout the trial. The study population will be intent-to-treat and the between-group differences at the primary endpoint will be assessed using an analysis of covariance (ANCOVA) with pre-score of the measure as covariate. A health-economic evaluation will assess the cost-effectiveness of the intervention.


Eligibility Criteria:
Inclusion Criteria:

≥ 18 years of age.

Primary diagnosis of TS/CTD, according to criteria in Diagnostic and Statistical Manual of mental disorders 5th edition.

Provided digital informed consent.

Have a Total Tic Severity Score (TTS) of \>15, or \>10 for individuals with motor or vocal tics only, in the past week, as measured by the Yale Global Tic Severity Scale (YGTSS).

Being willing and able to follow the study procedures and participate in the 10-week treatment program.

Being fluent in Swedish.

Have regular access to a computer connected to the Internet, sufficient technical skills to use the treatment platform, as well as a mobile phone to receive text messages.

Exclusion Criteria:

Ongoing or planned psychological treatment for TS/CTD.

Previous BT for tics of a minimum of 8 sessions with a qualified therapist within 12 months prior to assessment.

Adjustment of medication for tics within the last two months prior to assessment.

Severe psychiatric comorbidities such as organic brain disorders, bipolar disorder, ongoing psychosis, anorexia nervosa or substance use disorders that can interfere with the treatment for TS/CTD.

Acute psychiatric problems such as severe depression or suicidal risk needing immediate psychiatric care.

Severe tics causing immediate risk to the participants themselves or to others and requiring urgent medical attention.
Effect and Complication of Two Types of Nasogastric Tube Feeding for Elderly Dysphagia Patient After Stroke

Dysphagia is a common problem after stroke.Patients after stroke with swallow problem will have a nasogastric tube to be feeded. In this study , investigators have including and excluding criteria. Continous feeding group and intermittent feeding group had been widely used in enteral nutrition feeding in investigators' institution. Investigators will observe participants' nutrition condition and tube-feeding related complications. In continous group patients, participants usually are given prescribed enteral nutrient solution using nutrition pump in 24 hours; while in intermittent feeding group, participants will be given prescribed enteral nutrient solution in 4-5 times by special syringe. During the whole process, investigators will observe all participants' nutrition condition (body mass index, plasma albumin and calf girth) and tube-feeding related complications( regurgitation, aspiration,gastric retention, diarrhea,constipation). With all those data, the investigators will assess which feeding type is better.


Eligibility Criteria:
Inclusion Criteria:

* Older than 65 years old
* Clinical diagnosis of stroke( ischemic and hemorrhage)
* With moderate and/or sever swallow problem(water swallow test IV-V degree)
* With nasogastric feeding tube more than 4 weeks
* Do rehabilitation in our hospital or designated hospitals

Exclusion Criteria:

* Without nasogastric feeding tube
* Patients with fever and other infection
* Chronic or acute anoxia
* Poor obedience
* Quit treatment or go back home to take rehabilitation
* Critically ill or died
Research Into the Molecular Bases of a New Phenotype Combining Premature White Hair, Polycystic Kidney Disease, Aortic Dilation/Dissection and Lymphopenia

This study involves a single family, including 1 patient, father, mother and sister. The patient presented with a new phenotype associating premature white hair, renal polycystosis, aortic dilation/dissection and lymphopenia. Samples were taken in order to identify the origin of the symptomatology highlighted in the index case.

In addition, it was observed that mice invalidated for bcl-2, normal at birth and indistinguishable from control mice, showed, after one week, a phenotype similar to that observed in this patient.

The overlap between the patient's main clinical signs (lymphopenia, white hair and polycystic renal disease) and the manifestations presented by the invalidated murine model for BCL2 suggests that its phenotype may be secondary to a Bcl-2 expression defect.


Eligibility Criteria:
This study involves a single family, including 1 patient, father, mother and sister.
A Study of Donanemab (LY3002813) in Healthy Participants

The main purpose of this study is to assess how fast donanemab (LY3002813) gets into the blood stream and how long it takes the body to remove it when administered as single dose in healthy participants. The study will also evaluate the safety and tolerability of donanemab. The study will last up to approximately 22 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Participants who are overtly healthy as determined by medical evaluation
* Have a body mass index (BMI) of 19.0 and 32.0, kilograms per meter squared (kg/m²), inclusive.
* Females of childbearing potential will be excluded from the study.

Exclusion Criteria:

* Have allergies to either humanized monoclonal antibodies, diphenhydramine, epinephrine, or methylprednisolone
* Have a history within the past 5 years of a primary or recurrent malignant disease
* Have used over-the-counter or prescription medications, including herbal medication, within 7 days prior to dosing
* Are pregnant or intend to become pregnant or to breastfeed during the study
* Smoke more than 10 cigarettes per day or are unable to abide by investigative site smoking restrictions
* Have a history of intracranial hemorrhage, cerebrovascular aneurysm or arteriovenous malformation, carotid, carotid artery occlusion, stroke or epilepsy or family history of dementia or Down's syndrome
A Study of Azacitidine and Venetoclax Versus a Stem Cell Transplant in People 65 Years and Older With Acute Myeloid Leukemia

The researchers are doing this study to find out if an allogeneic hematopoietic stem cell transplant (HSCT) or maintenance therapy with azacitidine and venetoclax is more effective at keeping AML from coming back (relapsing).


Eligibility Criteria:
Inclusion Criteria:

* Adult patients ≥65 years of age at the time of signing the informed consent form.
* Confirmed diagnosis of acute myeloid leukemia according to the ELN 2017 criteria
* Treatment with azacitidine and venetoclax for the diagnosis of AML

  o The first cycle of study treatment will start 28-42 days after the start of the second cycle of SOC AZA/VEN. In the event that patients can't be admitted for allo-HCT until after Day 42 due to donor related issues, an additional cycle of AZA/VEN will be allowed as a bridge to the transplant, and then initiation of conditioning will start no later than day 42 after the start of the third cycle.
* Patients with adequate organ function to be considered as candidates for allo-HCT:

  * Cardiac: asymptomatic or if symptomatic, then LVEF at rest must be \>40% and must improve with exercise.
  * Renal: CrCl ≥50 ml/min (measured or calculated/estimated).
  * Pulmonary: asymptomatic or if symptomatic, DLCO \> 50% of predicted (corrected for hemoglobin)
  * Hepatic: \< 5x ULN liver function tests and \< 2x ULN total serum bilirubin, unless there is congenital benign hyperbilirubinemia.
  * KPS of ≥ 70
* Patients with suitable donor for allo-HCT
* Patients must achieve a morphologic remission \<5% blast meeting one of the below:

  * Complete remission (CR) defined as: \<5% blasts with ANC\> 1000 AND Plt \>100K
  * CRh defined as \<5% blasts with ANC \> 500 AND Plt \>50K
  * CRi defined as \<5% blasts with ANC\< 1000 OR Plt \< 100K
* Subject is willing and able to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria:

* Patients who are not considered to be transplant eligible (either due to lack of suitable donor or due to comorbidities/performance status). The reason the patient is not considered transplant eligible will be documented in the eCRF.
* History of prior allo-HCT
* Patients who underwent prior leukemia directed treatment (other than aza/ven)
* Patients with CNS involvement at any time point prior to enrollment.
* Patients with previous exposure to venetoclax or an HMA for the treatment of a myeloid malignancy
* Patients who are planned for treatment other than AZA/VEN
* Patients who are planned for treatment with HMA/VEN with another agent (e.g. a "triplet")
* Presence of any other condition that may increase the risk associated with study participation, and in the opinion of the investigator, would make the patient inappropriate for entry into the study.