cyrilzakka/clinical-trials huggingface dataset:
Humanistic Care in Patients With Coronavirus Disease 2019

As of February 17th, 2020, China has 76396 confirmed cases of coronavirus disease 2019 (COVID-19), including 2348 deaths. Although the impact factors of clinical outcomes among hospitalized patients still need to be clarified, some of the therapeutic regimens have shown the potency in the treatment of severe cases. Investigators aim to evaluate the efficacy of psychological and physical rehabilitation based humanistic care in the treatment of COVID-2019.

As of February 17th, 2020, China has 76396 confirmed cases of coronavirus disease 2019 (COVID-19), including 2348 deaths. Although the impact factors of clinical outcomes among hospitalized patients still need to be clarified, some of the therapeutic regimens have shown their potency in the treatment of severe cases. Investigators aim to evaluate the efficacy of psychological and physical rehabilitation based humanistic care in the treatment of COVID-2019. As the national medical team sent to Wuhan, investigators proposed a Psychological and physical rehabilitation based humanistic care regimen generated from our experience in treating patients with COVID-2019. In addition to routine therapy, investigators will apply this comprehensive humanistic care regimen to the patients according to their condition to see the efficacy to this regimen.

Eligibility Criteria:
Inclusion Criteria:

* Inpatients with 2019 Novel Coronavirus infection

Exclusion Criteria:

* Patients can not follow-up;
* Investigator considering inappropriate.
The Effect of HMB Supplementation on Adipose Tissue Inflammation and Metabolism

This study will determine the effects of supplementing beta-hydroxy-beta-methylbutyrate (HMB) on body composition and strength changes during weight loss. When overweight and obese persons lose weight, and in particular in conjunction with dietary restrictions, muscle, bone mass, and muscle strength are also lost. HMB has been shown to preserve muscle mass and strength, and it is thought that HMB may also preserve muscle, bone, and strength during weight-loss.

Forty obese men (BMI 35-40 kg/m2,18-40 years of age) will be randomly assigned to one of four treatment interventions: 1) Calorie restricted; 2) Calorie restricted and HMB supplemented; 3) No calorie restriction; and 4) No calorie restriction and HMB-supplemented. Over the 8 week interventional period the calorie restricted group is expected to lose 3-5% of initial body weight. Anthropometric measures will be taken weekly, and dual energy x-ray absorptiometry (DXA) body composition and strength will be measured before and after 8-weeks of intervention. Blood and urine will be collected and analyzed at 0, 4, and 8 weeks. Additionally Dietary records and questionnaires concerning quality of life will be administered, and activity will be assessed using questionnaires and pedometers. Muscle biopsies will be taken before and after the 8-week study.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Non-smoker
* Body mass index of 35-40 kg/m2
* Age 18-40 years
* Weight stable for past 6 months (\<5 lb. change)
* In good health, free of chronic diseases/conditions that may impact measured outcomes
* Willing and able to consume a weight loss diet
* Willing and able to consume a daily nutritional supplement (in pill form)
* Available for scheduled study commitments during the 2 months of study

Exclusion Criteria:

* Smoke
* Take any cholesterol lowering or weight loss drugs or an drugs or supplements that affect blood lipids, insulin or body composition
* Weigh greater 300 pounds due to weight, size and depth limitations of equipment
* Take dietary supplements
* Have a chronic disease such as:
* Cardiopulmonary disease (e.g. recent myocardial infarction, unstable angina, stroke) or unstable disease
* Severe orthopedic/musculoskeletal or neuromuscular impairments that would contradict exercise
* Sensory impairments that interfere with following directions
* Diagnosis if dementia
* History of malignancy during the past 5 years
* Diabetes mellitus
A Phase 3 Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty

The objective of this study is to assess the efficacy and safety of DU-176b compared with enoxaparin sodium for the prevention of venous thromboembolism in patients after elective total knee arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing unilateral total knee arthroplasty

Exclusion Criteria:

* Subjects with risks of hemorrhage
* Subjects with thromboembolic risks
* Subjects who weigh less than 40 kg
* Subjects who are pregnant or suspect pregnancy, or subjects who want to become pregnant.
Pilot Study for the Evaluation of the Safety and Performance of the RenaSense System in Hospitalized Acute Decompensated Heart Failure Patients

The study is intended to verify the safety and assess the performance of up to 3-days treatment protocol with the RenaSense System in ADHF patients.


Eligibility Criteria:
Inclusion Criteria:

1. Females
2. Age 18-85 years
3. Admitted to the hospital with a primary diagnosis of decompensated heart failure
4. Estimated glomerular filtration rate (GFR)\* ≤60 ml/min and ≥20 ml/min, based on serum creatinine at initial evaluation
5. History of chronic use of oral loop diuretics (≥ 80 mg/day Furosemide or equivalent) during the past 3 months
6. Indication for treatment with intravenous diuretics
7. Volume overload

   For patients with a pulmonary artery catheter, persistent volume overload will include:
   * Pulmonary capillary wedge pressure greater than 22mmHg and one of the following clinical signs:
   * at least 2+ peripheral edema and/or
   * Pulmonary edema or pleural effusions on chest x-ray

   For patients without a pulmonary artery catheter, persistent volume overload will include at least two of the following:
   * At least 2+ peripheral edema
   * Jugular venous pressure greater than 10 cm on physical examination (or central venous pressure greater than 10 mmHg when measured)
   * pulmonary edema or pleural effusions on chest x-ray
8. Indication for urinary catheterization
9. BNP \> 400 pg/mL at initial evaluation
10. Able and willing to sign the informed consent

Exclusion Criteria:

1. History of urinary tract infection within the last 1 month based on medical history and/or urinalysis on day of admission
2. Gross hematuria, perineal hematoma or symptomatic microscopic hematuria
3. Hypertension, systolic \>180 mmHg or diastolic \> 110 mmHg
4. Hypotension, systolic pressure \<100 mmHg
5. Status post renal denervation
6. Implanted cardiac rhythm management device such as pacemakers, cardiac resynchronization therapy (CRT), Implantable cardioverter-defibrillator (ICD)
7. Suspected or known pregnancy
8. Previous organ transplantation
9. Life threatening condition such as severe infection, malignancy or infarction
10. Subject is participating in other concurrent clinical investigation
11. Diseases or conditions which, in the judgment of the investigator, preclude participation in the clinical trial
Efficacy Study of Sargramostim in the Retreatment of Patients Who Have Crohn's Disease Who Have Previously Responded to Treatment With Sargramostim

The purpose of this study is to evaluate whether treatment with Leukine in patients with Crohn's disease who have previously responded to Leukine can be helped again, once they have relapsed.

On 29 May 2009, Bayer began transitioning the sponsorship of this trial to Genzyme. NOTE: This study was originally posted by sponsor Berlex, Inc. Berlex, Inc. was renamed to Bayer HealthCare, Inc.

Eligibility Criteria:
Inclusion Criteria:

* You must be 18 years or older.
* You must have active Crohn's disease at the time of screening.
* You must be 18 years or older.
* You must have active Crohn's disease at the time of screening.
* You must be able to give yourself an injection of study drug or have another person who can help you give the injection.
* You must not be pregnant and agree to use birth control if you are a sexually active male or female of childbearing potential.

Exclusion Criteria:

* You may not be pregnant or breastfeeding.
* You may not have a colostomy or ileostomy.
* You may not be taking prohibited medications.
* You may not have had GI surgery or a bowel obstruction in the last 6 months.
* You may not have ever taken this drug or drugs of similar type in the past.
Histological Analysis of AlloMend® Acellular Dermal Matrix Used in Breast Implant Surgeries

This is a prospective, histologic analysis of biopsied tissue obtained from participants who have undergone a pre-pectoral breast reconstruction or augmentation surgery with expander placement and AlloMend® Acellular Dermal Matrix.

AlloMend® Acellular Dermal Matrix graft incorporation with surrounding native soft tissue using histological assays characterizing host cell infiltration, neovascularization, inflammation, and host replacement of ADM collagen will be studied.

The purpose of this study is to evaluate the incorporation of AlloMend® Acellular Dermal Matrix with native surrounding tissue by obtaining up to three, 1 cm diameter biopsies per breast. The samples will then be transported to AlloSource Research and Development Labs for slide preparation and histologic analysis.

This study will be performed at one (1) clinical center in the United States.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age;
* AlloMend® Acellular Dermal Matrix used during the initial prepectoral placement of tissue expanders for breast reconstruction;
* Is scheduled or will be scheduled for a procedure to exchange the tissue expander for permanent breast implant;
* Can understand the requirements of the study, has provided written, informed consent, and to comply with the study protocol.

Exclusion Criteria:

* Mentally compromised (e.g., being currently treated for a psychiatric disorder, senile dementia, Alzheimer's disease) in a manner that would compromise his or her ability to consent to participate in the clinical study;
* Subjects who, in the opinion of the investigator, would not be able or willing to comply with the protocol.
Combination of Supplements for Treating Autistic Spectrum Disorder

A pilot study to compare the efficacy of a combination of apitherapy supplements versus placebo in children with autistic spectrum disorder.

A prospective, double-blind, placebo-controlled, crossover, multicentre clinical study which will enrol up to 45 children diagnosed with ASD (enrolment will stop when 40 children have completed the study). Children ages 3-14 will be tested before and after administering the combination of active substances (3 months) and placebo (3 months). The duration of participation in the study for each child will be 6 months. The supplements tested consist of three products - a combination of apitherapy and plant extracts - which have been approved for sale as individual supplements for more than 5 years in Romania - Apicol 12 gamma, Laptisor de matca activat (Royal Jelly) and Telom R Cerebral. Participation in the study is free and all children will be comparatively evaluated with the ATEC and ASRS scales and three sets of blood tests.

Eligibility Criteria:
Inclusion Criteria:

* age 3-14 years
* diagnosed with typical or atypical autism spectrum disorder (F84.0 or F84.1) and received at least one therapeutic intervention before enrolling
* the ability to follow an oral treatment, with TID/BID/QD administration
* the availability to perform 3 sets of blood tests at a clinical laboratory within 6 months (initial, at 3- and 6-months)
* the availability to perform 3 visits to the Investigator and 3 psychometric evaluations within 6 months

Exclusion Criteria:

* patients enrolled in another interventional clinical trial currently or which ended less than 1 month prior to enrolling in this study
* known allergy to hive products or one of the substances studied
* inability to perform the study requirements (3 visits to the Investigator, 3 psychometric assessments, 3 sets of blood tests)
* diagnosis of diabetes
* history of seizures/epilepsy
* administration of anticoagulants, antiplatelets, thrombolytic agents, low molecular weight heparins, anticonvulsants, insulin, monoamine oxidase inhibitors, non-steroidal anti-inflammatory drugs or thiazide diuretics
* allergy to celery and other plants of the Fam. Apiaceaea (Umbelliferae)
* abnormally elevated baseline (at V1) values of ferritin, homocysteine, HgbA1c, ESR
Impact of the Geographical FACTor on the Prostate Cancer Stage at Hormonal Therapy Initiation

French epidemiological data have shown a heterogeneous distribution of the risk of mortality from prostate cancer according to region. The main objective is to describe the distribution of prostate cancer stages when first line hormonal therapy is introduced (overall and by region).


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically demonstrated prostatic adenocarcinoma.
* Patients never previously treated with hormonal therapy for prostate cancer.
* Patients eligible for hormonal therapy after initial consultation (alone or in combination with curative treatment).
* Patients agreeing to the collection of personal health data for the purposes of the study.
* Patients with locally advanced or metastatic prostatic cancer tumours or a biological recurrence after curative treatment.

Exclusion Criteria:

* Patients participating in a clinical study involving prostate cancer at the time of inclusion in the investigation.
* Patients having received or currently receiving hormonal treatment for prostate cancer (surgical castration or other hormonal manipulation, including GnRH receptor antagonists, antiandrogens, oestrogens, 5 alpha reductase inhibitors).
Treatment of Chronic Pain After Spinal Cord Injury (SCI) or Amputation

Pain is a major problem for people after spinal cord injuries and amputations. This is a study to test how pain is affected by adding methadone to a six-week program of weekly physical therapy, relaxation training and counseling. Individuals who qualify for this study will receive a comprehensive medical and physical therapy evaluation.

Pain has a major impact on the functioning of individuals with spinal cord injuries and individuals with amputations. This double-masked randomized trial to evaluate the utility of a combination of psychological intervention and physical therapy in order to improve pain reduction, increase physical functioning and quality of life for patients with pain associated with spinal cord injuries or amputations will compare the effect of a 6 week program of physical therapy and cognitive-behavioral therapy with methadone to one without methadone (n = 400). Secondary outcomes are to evaluate the maintenance of effects of the combined intervention and to evaluate the usefulness of a course of opioid therapy compared to active placebo medication. Based on the sample size, all measures have greater than 0.7 power to detect major within group differences at posttreatment, 6-month follow-up, and 12-month follow-up (taking into account a 15% attrition rate, alpha .05). Patients who qualify for this study will receive a comprehensive medical and physical therapy evaluation at baseline. Outcome will be assessed by the physician, psychiatrist and physical therapist who are all masked both to the treatment condition and therapy. Pain is assessed through self-report (measures include pain inventories) and clinical interview.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with spinal cord injury or amputation, who have persistent pain of three months or longer duration.

Exclusion Criteria:

* Pregnant women
* Allergy to latex, methadone, or diphenhydramine
* Surgery planned
* History of substance abuse in past two years
* History of major psychiatric disorder
Continuous Glucose Monitoring for Outpatient Diabetes Management After Hospital Discharge

This study aims to improve patient awareness of the utility of continuous glucose monitoring systems in blood glucose monitoring and to improve patient satisfaction regarding diabetes care, particularly in the matter of blood glucose monitoring, at the transitions of care from the inpatient setting to the ambulatory setting.


Eligibility Criteria:
Inclusion Criteria:

* Non-pregnant adults, ages greater than or equal to 18 years, admitted to VUMC
* Able to give informed consent
* Hyperglycemia requiring insulin therapy including subcutaneous insulin injection or continuous subcutaneous insulin infusion (patient's own insulin pump) during hospitalization and at the time of discharge
* POC glucose or venous glucose levels in the 24 hours prior to participation need to be 70-350 mg/dL
* Need glucose readings greater than or equal to one time per day
* Mental status and dexterity adequate to use Libre 3 Plus or Dexcom G7 sensors with Libre 3 or Dexcom G7 application on patient's smartphone

Exclusion Criteria:

* Currently using Libre 3 Plus or Dexcom G7 CGMS during hospitalization or have used Libre 3 Plus or Dexcom G7 CGMS in the past 3 months
* Does not have smartphone compatible with Libre 3 App or Dexcom G7 App
* Received chemotherapy during current hospitalization
* Planning on major surgery within 10-15 days
* Hemodialysis or peritoneal dialysis
* Requiring vasopressors, intubation, sedation, or admission to an intensive care unit
* Vitamin C use of more than 500 milligrams per day
* Hydroxyurea use
* Acetaminophen use of more than 4 grams per day or 1 gram every 6 hours
* Significant pitting edema (3+ or greater) i.e. cirrhosis with ascites, congestive heart failure with edema, nephrotic syndrome, or signs of poor perfusion
* Presentation in diabetic ketoacidosis or hyperosmotic nonketotic state
* Skin allergy to adhesives
Mechanical Complications After Central Venous Catheterisation

Central venous catheters are common in modern health care and are being increasingly used in both intensive care units and general wards. The primary aim of this study is to determine the incidence of mechanical complications within 24 hours after central venous catheterisation. The secondary aim is to identify risk factors associated with mechanical complications within 24 hours after catheterisation.

Central venous catheters provide reliable access to the bloodstream, which allows delivery of medications and nutritional support that cannot be given safely through peripheral venous catheters.

Mechanical complications of central venous catheterisation include bleeding (such as hematoma and hemothorax), cardiac arrhythmia, arterial puncture, arterial catheterisation, nerve injury, pneumothorax, failed catheterisation and catheter tip malposition. The most common mechanical complications are arterial puncture, hematoma formation and pneumothorax. The number of mechanical complications related to central venous catheterisation varies widely in previous studies with incidences between 1.1 and 34 %. Ultrasound guidance reduces the incidence of mechanical complications, but despite evidence demonstrating improved safety, real-time ultrasound guidance is still not routinely used by all physicians when obtaining central venous access.

Four hospitals in Region Skåne, Sweden, will participate in this study: one university hospital with approximately 1300 beds and three county hospitals with about 200 beds each. All central venous catheter insertions at the participating hospitals during the study period will be included in the study.

The primary aim of this prospective, controlled, observational study is to determine the incidence of mechanical complications within 24 hours after central venous catheterisation. The secondary aim is to identify independent risk factors of mechanical complications within 24 hours after insertion of central venous catheters.

Eligibility Criteria:
Inclusion Criteria:

* All patients receiving a central venous catheter will be observed

Exclusion Criteria:

* Patients that dies within 24 hours after insertion of a central venous catheter
Suicidal Ideation and Behavior in Korean Adolescents With Depression

The purpose of this study is to examine clinical characteristics of Korean adolescents with depression who have suicidal ideation and behavior. We formulate those hypotheses.

1. Being bullied in peer relationships, excessive use of internet, excessive extra-curricular tutoring, sexual abuse in childhood, physical abuse and emotional neglect are risk factors of suicide in adolescents.
2. Depression of parents and negative child-rearing attitude are risk factors of suicidal ideation and behavior in adolescents.
3. Emotional quotient (EQ) and resilience of adolescent are protective factors of suicide.

Korea has reported the highest suicide rate among OECD members and according to the data from the Korea national statistical office, suicide is the second major cause of death in adolescents and is increasing. Depression, one of the well-known risk factors of suicide in adolescents, can cause maladjustments to school and family life, problems of interpersonal relationship and drug abuse so that work to trigger the suicidal ideation and behavior. In his study, we planned to examine the relationship between suicidal ideation and behavior and several risk factors by using the standardized diagnostic clinical interview, especially an objective suicide evaluating method which has recently developed.

Eligibility Criteria:
Inclusion Criteria:

* a subject who has depression (Major depressive disorder, dysthymic disorder, depressive disorder NOS) diagnosed by Kiddie-Schedule for affective disorder and schizophrenia (K-SADS-PL-K)
* subjects and their family (a parent or a grandparent) or their legal representative consent to participate in this study voluntarily
* subjects and their family (a parent or a grandparent) or their legal representative are able to understand the meaning of participation in this study and able to reject or ask to leave from this study

Exclusion Criteria:

* a patient who has diagnosed with bipolar disorder, psychotic disorder, pervasive developmental disorder, organic brain disease, or epilepsy
* a patient with mental retardation who is IQ under 70
* a patient who has a severe medical illness (chronic physical disease, cardiovascular, hepatobiliary, nephrology, or respiratory disease and so on)