cyrilzakka/clinical-trials huggingface dataset:
Social-software iMproving wARfarin Therapy

Poor anticoagulation quality is a major problem among Chinese patients receiving warfarin therapy in traditional health care settings. Improving warfarin therapy has been crucial for Chinese patients. Wechat is social-software in China. Most of all Chinese adults use Wechat, as well as our patients. So we set up a Wechat-based mini-program to instruct Chinese patients' warfarin therapy. We aim to assess whether social software could improve warfarin therapy in Chinese patients by conducting a single-centre, open-label, prospective, randomized clinical trial.

Social software is becoming a necessary of life. Wechat, powered by Tencent company, is the most popular social software in China. People can chat with others no matter how far away from each other.

Anticoagulation Quality is very important for patients receiving warfarin anticoagulation therapy, which is usually evaluated Time in therapeutic range (TTR). It is reported that TTR is very low (38.8%) in China patients. So we are planning to introduce the social software to set up a bridge for clinicians and their patients, to instruct warfarin therapy. We aim to investigate whether social software could be used to improve warfarin anticoagulation quality of Chinese patients.

We planned to enrol enough eligible patients receiving warfarin therapy due to the mechanical valves in a randomized controlled trial. Warfarin-treated patients were assigned to social software management group ( in which warfarin therapy was guided via the social platform by experienced clinicians) or to the traditional management control group (in which warfarin therapy was managed with traditional model). The primary outcomes the first time to bleeding or thrombotic events, the secondary outcomes were an elevation in time in therapeutic range (TTR) of international normalized ratio (INR), reduction in INR variation and number of extremely high INR results during 18 months.

Eligibility Criteria:
Inclusion Criteria:

* Received mechanical valve replacement;
* Receiving warfarin anticoagulation therapy;
* Have smartphone and Know how to use wechat application and our mini-program;
* be expected to survive for the duration of the study;
* not be suffering from intracranial bleeding (intracranial haemorrhage, subarachnoid haemorrhage, hemorrhagic stroke) or any other contraindication described in the warfarin package insert;
* be willing to be randomized;
* sign the informed consent form;
* not be enrolled in another randomized clinical trial that involves a drug or device intervention.

Exclusion Criteria:

* subject has had an intracranial haemorrhage, subarachnoid haemorrhage, hemorrhagic stroke, or any other absolute/major contraindication described in the warfarin package insert within the last month
* subject enrolled in another randomized clinical trial that involves a drug or device intervention
* subject is not able to follow the protocol and all related instructions and does not have a caregiver with these skills
* Patients were considered being not suitable for this study
Safety and Performance of the Automated Fluid Shunt in Patients With Ascites and Diuretic Resistance

To investigate the safety and performance of the Automated Fluid Shunt in patients with ascites and diuretic resistance.

Study Size and Duration The primary study population will include 40 patients enrolled and implanted with the NovaShunt Automated Fluid Shunt (AFS) in up to 15 centers in Europe.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years of age
* Recurrence of ascites defined as clinical reappearance of ascites within 4 weeks of initial paracentesis.
* Cirrhosis of any etiology
* Failure to respond to a maximum of 160 mg/d of furosemide and 400 mg/d of spironolactone (or equivalent doses of loop-acting and distal-acting diuretics), or intolerance to high dose diuretics because of hyponatremia, hyperkalemia, or other side-effects
* Dietary sodium restriction \<88mEq/d.
* Serum creatinine levels of ≤ 2.0 mg/dL for at least 7 days before study entry.
* Total bilirubin levels of less than 3 mg/dL.
* Expected survival of greater than 6 months
* Written informed consent
* Ability to comply with study procedures and ability to operate the device.
* Women of childbearing age should use adequate contraceptives

Exclusion Criteria:

* Presence of recurring systemic or local infection, such as peritonitis, urinary tract infection, or abdominal skin infection.
* Presence of peritoneal carcinomatosis
* Advanced hepatocellular carcinoma, demonstrated by:

  1. One tumor that is \>5 cm diameter
  2. 3 or more nodules of \>3 cm diameter
  3. Portal thrombosis
* Other evidence of a malignant Etiology for Ascites
* Evidence of extensive ascites loculation
* Gastrointestinal hemorrhage due to portal hypertension in the 2 weeks prior to the inclusion in the study.
* Hepatic encephalopathy in the two weeks prior to implant
* Presence of a TIPS or surgical portosystemic shunt
* Presence of Budd-Chiari syndrome
* Previous liver transplant
* Obstructive uropathy
* Coagulopathy that could not be corrected to a prothrombin time INR \<1.8,
* Thrombocytopenia that could not be corrected to a platelet count greater than 60,000/mm3
* Any other clinically significant disease that could be adversely affected by study participation judged by the Investigator
* Any condition requiring emergency treatment
* Pregnancy
* Patients being in another clinical study that did not reach primary endpoint yet
Prospective Low Dose CT for Total Shoulder Arthroplasty/Reverse Shoulder Arthroplasty

This study is a prospective, departmental funded study examining the outcomes of simulated Low Dose CT scans compared to Conventional Dose CT scans in patients who present to Duke University for total shoulder arthroplasty or reverse shoulder arthroplasty.

The purpose of this study is to compare the use of a conventional dose computed tomography scan (C-CT) to a simulated low dose computed tomography scan (L-CT) for preoperative planning in patients who are anticipated to undergo a total shoulder arthroplasty (TSA) or reverse shoulder arthroplasty (RSA) with the goal to reduce the radiation exposure to future patients undergoing preoperative planning. L-CT scans for analysis will be obtained prospectively as derived data from a C-CT scan performed on a dual source CT scanner. Briefly, a C-CT scan will be conducted, with scan images representing a reconstruction of simultaneous scans at two sensors. L-CT images will be derived from single source data (ie the scan data gathered by one of the emitters rather than a reconstruction from both). For additional validation, prospectively collected scans will be compared to retrospectively gathered scans of patients of similar demographics (age, sex, BMI) and degenerative changes who underwent a C-CT scan for an anticipated shoulder arthroplasty in the past. The reviewers will investigate the following outcome measures including 1) Are L-CT images of sufficient quality to be used for preoperative planning 2) Can accurate measurements including glenoid inclination, version, implant selection and humeral head subluxation be made on L-CT images 3) Do proposed treatment plans change with the use of L-CT relative to the chosen plans base on C-CT images. The investigators hypothesize L-CT images will be of sufficient image quality for diagnostic purposes, with similar measurements, and treatment outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Subjects are planned to undergo total or reverse shoulder arthroplasty
* Subject must be 18 years or older
* Subjects who have capacity to give informed consent

Exclusion Criteria:

* Subjects who are pregnant
* Subjects under the age of 18
* Subjects who do not have the capacity to give informed consent.
Application of Impedance Threshold Device Technologies to Treat and Prevent Hypotension During Dialysis

The purpose of this study is to evaluate the application of the impedance threshold device during hemodialysis in children to optimize fluid removal, reduce the incidence of complications (such as cramps,vomiting and hypotension), and device tolerance.

Effective fluid removal during hemodialysis is one of the biggest challenges in children with end-stage renal disease (ESRD). Generally, children do not tolerate having more than 3-4% of their body weight removed during each dialysis session thus necessitating multiple sessions each week to ensure effective renal replacement. Excessive fluid removal is often associated with nausea, vomiting, hypotension and cramps resulting in serious complications in patient care during and immediately after dialysis as well as reduced patient compliance. The development of novel therapies to increase the amount of fluid removed during each session without a corresponding increase in the incidence of complications is therefore very important to improve quality and compliance with hemodialysis; and eventually survival of children with ESRD. The purpose of this study is to evaluate the application of the impedance threshold device during hemodialysis in children to optimize fluid removal, reduce the incidence of complications (such as cramps,vomiting and hypotension), and device tolerance.

Eligibility Criteria:
Inclusion Criteria:

* Subjects 8-18 years of age
* Subjects undergoing hemodialysis for ESRD

Exclusion Criteria:

* Subjects less than 8 years old or greater than 18 years old.
* Hemodialysis for indications other than ESRD.
* Current symptoms of chest pain, shortness of breath, fever, presence of dilated cardiomyopathy, unstable congestive heart failure, pulmonary hypertension, atrial fibrillation, hyperthyroidism, and aortic stenosis.
Effects of Nasal Septal Surgery on Sleep Quality, Daytime and Dream Anxiety

The aim of this report was to assess the frequency of poor sleep quality, daytime and dream anxiety and their response to subsequent surgical treatment for a representative group patients with nasal septum deviation.

Prior to the surgery, nasal airflows and airway resistances were measured employing rhinomanometry and they were also asked to fill in the Pittsburgh Sleep Quality Index (PSQI), the Beck Anxiety Inventory (BAI), and the Van Dream Anxiety Scale (VDAS). And, a postoperative assessment for the same parameters was made at two months from the day of the surgery.

Eligibility Criteria:
Inclusion Criteria:

* All participants, 18 to 65 years of age, had septal deviation consistent with the presenting symptoms which last at least three months and persist after a three months trial of medical management, including topical nasal steroids, topical or oral decongestants, or an oral antihistamine/decongestant combination.

Exclusion Criteria:

Patients were excluded from the study if they had nasal septal surgery performed for other reasons, such as

* an access to nasal and sinus tumors,
* pituitary surgery and as part of treatment for sleep apnea or with concurrent sinus surgery;
* had rhinoplasty prior to submucous resection;
* had acute nasal trauma;
* had adenoid hypertrophy;
* had uncontrolled asthma/nasal allergy;
* had diagnosed or suspected (snoring with/without other symptoms, such as apneas referred by someone and/or somnolence) OSA;
* had obesity (BMI ≥ 30.0 kg/m2);
* had an unstable physical disorder;
* had a current or lifetime history of any functional or organic mental disorder;
* had a history of seizures;
* had a neurological disorder that significantly affects central nervous system functions;
* had met criteria for substance abuse or dependence in the previous 12 months, including nicotine dependence;
* were taking medications that may cause or exacerbate sleep problems, daytime and dream anxiety; had clinical or laboratory evidence of hypothyroidism without adequate and stable replacement therapy;
* had a history of antidepressant or sedative-hypnotic medications for any current or past complaint;
* were pregnant or breastfeeding; or
* were women not using effective contraception.
Effect of Glycopyrrolate on Nausea and Vomiting After ERCP Operation

This study aims to determine the role of Glycopyrrolate in preventing postoperative nausea and vomiting of ERCP.

This study is a prospective, double-blind, randomized controlled trial. Patients who meet the criteria of our center and need to undergo ERCP lesion resection will be included and randomly divided into groups. After receiving Glycopyrrolate (experimental group) and Anisodamine (control group), duodenal peristalsis, biliary and pancreatic treatment time and postoperative nausea and vomiting will be observed during therapeutic ERCP. The inhibitory effect of Glycopyrrolate on postoperative nausea and vomiting of ERCP will be analyzed statistically.

Main outcome measure: incidence of nausea and vomiting after ERCP Secondary outcome measures: mean duodenal contractions per minute, duodenal spasm frequency and score, ERCP operation time, occurrence of other side effects of medication, remedial medication, and incidence of adverse events

Eligibility Criteria:
Inclusion Criteria:

* 1.Adults 18-80 years old 2.ASA :I-III 3.Patients who are able to give informed consent and are currently planning to have the lesion removed or examined at the descending ERCP

Exclusion Criteria:1: Use of anticholinergic drugs

2: pregnancy

3: glaucoma

4: Myasthenia gravis

5: Obstructive gastrointestinal diseases

6: Obstructive urinary tract disease (prostatic hyperplasia)

7: Heart disease (coronary heart disease, congestive heart failure)

8: hyperthyroidism

9: Previous history of abdominal or intestinal surgery

10: Chronic renal failure

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Computer-Based Behavior Change Guide in Increasing Physical Activity in Patients With Prostate Cancer Who Have Received Androgen Deprivation Therapy

This randomized pilot clinical trial studies how well a computer-based behavior change guide works in increasing physical activity in patients with prostate cancer who have received androgen deprivation therapy. A computer-based behavior change guide website may increase physical activity level for prostate cancer survivors and help doctors understand what outcomes related to becoming physically active are most important to patients with prostate cancer.

PRIMARY OBJECTIVES:

I. Engage with prostate cancer patients (PCPs) who have received or are currently on androgen deprivation therapy (ADT) to develop a computer-based behavior change guide (BCG) for PCPs to provide fundamental information about benefits of exercise for their individual capabilities and goals and provide a personalized physical activity plan. (Development Phase) II. Engage with PCPs to understand what outcomes are most important to them related to becoming active (e.g., helped me manage side-effects of treatment, reduced fatigue) and develop measures to evaluate these patient-centered outcomes. (Development Phase) III. Evaluate the BCG in a study comparing the personalized computer-based BCG with physical activity recommendations provided via a passive website (American Cancer Society Guidelines on Nutrition and Physical Activity for Cancer Survivors) among PCPs who have received ADT. (Evaluation Phase)

OUTLINE:

DEVELOPMENT PHASE: Patients view mock-ups of the BCG web design on a computer, iPad, or printed color paper and provide feedback with a one-on-one interview or separately using the think/talk aloud method followed by a one-on-one interview. After completion of these design rounds, patients use the BCG website and provide individual feedback.

EVALUATION PHASE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients use the BCG website which will collect personal information including individual health priorities/goals, demographics (i.e. age, ethnicity), health information (i.e. weight, height, cancer history, other health conditions), individual capabilities, physical activity level, and exercise preferences. Patients then receive a report with a personalized physical activity plan.

GROUP II: Patients use a passive website (American Cancer Society Guidelines on Nutrition and Physical Activity for Cancer Survivors).

After completion of study, patients are followed up at 2 months.

Eligibility Criteria:
Inclusion Criteria:

* Prostate cancer (PCa) diagnosis
* Able to read English on a computer screen
* Signed an Institutional Review Board (IRB)-approved informed consent
* EVALUATION PHASE
* Underactive (defined as physically active for less than 30 minutes per day fewer than 2 days per week)
* Access to a computer at home or public location

Exclusion Criteria:

* Non-English speaking subjects are excluded from this study; the website being developed will only be available in English
Pecto-Intercostal Fascial Block for Postoperative Analgesia After Cardiac Surgery

The purpose of this study is to determine whether administration of a pecto-intercostal fascial plane block (PIFB) with bupivacaine is a more effective therapy for postoperative analgesia after cardiac surgery as compared to patients who receive a sham block of normal saline.

The purpose of this study is to determine whether administration of a pecto-intercostal fascial plane block (PIFB) with bupivacaine is a more effective therapy for postoperative analgesia after cardiac surgery as compared to patients who receive a sham block of normal saline.

Specific Aim 1: To determine whether or not a PIFB with bupivacaine can reduce postoperative pain after cardiac surgery. This will be assessed through:

(Aim 1A) opioid consumption in the first 48 hours postoperatively (Aim 1B) patient self-reported pain scores during their hospital stay

Specific Aim 2: To estimate the effect size in order to obtain information that can be used to power future research on the use of regional modalities of analgesia for cardiac surgeries.

Eligibility Criteria:
Inclusion Criteria

* Patients 18 years of age or older
* Undergoing cardiac surgery with sternotomy, limited to CABG, CABG+valve surgeries and isolated valve surgeries.

Exclusion Criteria

* Current participation in another interventional study
* Preoperative LVEF \< 30%
* Use of mechanical circulatory support
* Emergent procedures
* Aortic surgeries, transplants ventricular assist device insertions, bentall, or grafts
* Minimally invasive cardiac procedures or those with thoracotomy approach
* Patients receiving other modalities of regional anesthesia like intrathecal morphine
* Chronic opioid use for chronic pain conditions with tolerance (total daily dose of an opioid at or more than 30 mg morphine equivalent for more than one month within the past year)
* Current use of TCA, gabapentin, or pregabalin
* Hypersensitivity to bupivacaine
* Women who are pregnant or breastfeeding
* Non English speaking
Study of the Safety and Efficacy of CC-5013 Treatment For Patients With Myelodysplastic Syndrome

To estimate the percent of patients with myelodysplastic syndromes (MDS) who experience erythroid response and the interval to response with daily treatment of 25 mg of CC-5013 .


Eligibility Criteria:
* Diagnosis of de novo myelodysplastic syndrome of at least 12 weeks duration.
* Baseline mean hemoglobin \< 10.0 g/dL (untransfused) and/or be transfusion dependent defined by requiring at least 4 units of RBC in the 8 weeks prior to baseline.
* More than 30 days must have elapsed since any previous treatment for MDS, other than transfusion.
* Women must not be pregnant or lactating
* No use of another experimental study drug within 30 dy\\ays of baseline
* Understand and sign written informed consent
* Able to adhere to study visit schedule, understand and comply with other protocol requirements.
Microbiome and Immunosuppression: The Mission Study

The purpose of this research is to study immunosuppression drugs, certain foods, and how they can change the microbiome (the natural microorganisms inside the body) of the individual taking the immunosuppressive medications. The study team wants to study how the microbiome affects how the body processes the transplant medication.

Immunosuppression drugs, like antibiotics and certain foods, can change the microbiome (the natural micro-organisms inside the body) of the individual taking the drug. The study team wants to study what impact these changes to the microbiome have on the individual. The study team is specifically interested in how these changes to the microbiome may change the metabolism (breakdown) and action of medications. It is already known that individual genetics impact the metabolism, absorption, and toxicities of some medications. It is suspected that the microbiome will have similar impacts on medications. With a better understanding of how individual microbiome impacts immunosuppressant medications used to help transplant recipients from rejecting their new organs, providers can more accurately prescribe and dose these medications to better treat and care for transplant patients and their organs.

It is expected that participants will be in this research study for up to 12 years. There will be periods of time that requires active participation (visits) and periods of time that will be more passive participation (allowing study staff to follow-up with medical records for outcomes).

Eligibility Criteria:
Inclusion Criteria:

* Participants undergoing kidney transplant
* Male or female at least 18 years of age at time of enrollment
* Will or have received a living or deceased donor kidney transplant
* Planned post-transplant immunosuppression regimen of mycophenolate mofetil dosed every 12 hours (Cellcept or generic) and immediate release tacrolimus dosed twice daily with trough concentration monitoring (generic or brand formulation).
* Able and willing to complete study-related procedures and visits
* Signs written informed consent

Exclusion Criteria:

* Recipient of a previous non-kidney transplant
* Subject is a multi-organ transplant recipient
* Presence of active gastroparesis and documented in medical record
* Liver dysfunction (total bilirubin \>2x upper limit of normal) within 2 months of enrollment
* Patients that take medications that significantly inhibit UGT enzymes.
* Patients that take medications that significantly inhibit or induce the biliary transporters
* Patient is known to be HIV positive
* Pregnant or nursing (lactating) women
* Non-English speaking
* Patients who have undergone bariatric surgery
Perfusion Index Changes in Cardiovascular Autonom Neuropathia Type-2 Dm Whit Spinal Anesthesia

Cardiovascular autonomic neuropathy in diabetic patients, hypertension, sympathovagal imbalance, orthostatic hypotension, painless myocardial infarction, ischemia, left ventricular dysfunction, cardiac sympathetic and parasympathetic innervation disturbances, qt interval prolongation and sudden deaths observed. The purpose of this study is to evaluate the relationship between cardiovascular autonomic neuropathy and perfusion index in spinal anesthesia

Cardiovascular autonomic neuropathy in diabetic patients, hypertension, sympathovagal imbalance, orthostatic hypotension, painless myocardial infarction, ischemia, left ventricular dysfunction, cardiac sympathetic and parasympathetic innervation disturbances, qt interval prolongation and sudden deaths observed. The purpose of this study is to evaluate the relationship between cardiovascular autonomic neuropathy and perfusion index in spinal anesthesia

Eligibility Criteria:
Inclusion Criteria:

* the patient will be operated with spinal anesthesia
* over 18 years
* no additional disease and only DM

Exclusion Criteria:

* patients with additional disease
* patients under 18 years of age
* patients contraindicated in spinal anesthesia