cyrilzakka/clinical-trials huggingface dataset:
Lactated Ringer's Solution to Prevent Post-ERCP Pancreatitis

This is a randomized, double-blinded, controlled trial. This study is a head to head comparison of normal saline (NS) infusion versus Lactated Ringer's (LR) infusion in patients, with the primary outcome of post-ERCP pancreatitis occurrence. Patients will be randomized to either the NS infusion group or the LR infusion group. IVF will be started pre-procedurally and will be continued throughout the procedure. A IVF bolus will be given at the end of the procedure and then continued as a continuous infusion. Our null hypothesis is that there will be no significant difference in the rate of occurrence of post-ERCP pancreatitis between the infusion of LR and NS solutions. Our alternative hypothesis is that patients receiving LR solution infusion will experience a decreased rate of post-ERCP pancreatitis compared to patients receiving NS solution infusion.


Eligibility Criteria:
Inclusion Criteria:

i. Possession of one of the following criteria which places the patient at high risk for post-ERCP pancreatitis and/or if patient is to undergo a planned endoscopic intervention deemed at high risk:

1. Suspicion of Oddi dysfunction
2. Personal history of post-ERCP pancreatitis
3. More than 8 cannulation attempts
4. Precut sphincterotomy
5. Endoscopic papillary balloon dilation of an intact sphincter
6. Endoscopic pancreatic duct sphincterotomy
7. Ampullectomy
8. Total bilirubin \< 1.0

ii. Or possession of two or more of the following minor criteria:

1. Female sex
2. Age under 50 years
3. Personal history of recurrent acute pancreatitis
4. Pancreatic duct injection leading to "acinarization" or over 3 pancreatic duct injections
5. Pancreatic duct cytology acquisition

Exclusion Criteria:

1. Patients aged less than 18
2. Inability to provide informed consent
3. Pregnancy
4. Active acute pancreatitis
5. Any contraindication to aggressive IVF hydration: evidence of clinical volume overload (peripheral or pulmonary edema), respiratory compromise (oxygen saturation \< 90% on room air), chronic kidney disease (creatinine clearance \< 40 mL/min), systolic congestive heart failure (ejection fraction \< 45%), cirrhosis, and severe electrolyte disturbance with sodium \<130 mEq/L or \>150 mEq/L
6. If patient does not undergo a planned high-risk intervention
7. If patient does not possess complete criteria which places them at high risk for post-ERCP pancreatitis
8. Patients with cholangitis
9. Patients with chronic and/or active pancreatitis
10. Patients with a true NSAID allergy
11. Patients greater than or equal to 75 years old
Trial Comparing Tack Versus Histoacryl Mesh Fixation After Endoscopic TEP(Total Extraperitoneal) Repair for Bilateral Inguinal Hernia

This prospective randomized trial is performed to analyze the post-operative pain (acute and chronic) after endoscopic TEP repair after bilateral inguinal hernia repair.

consecutive patients with bilateral inguinal hernias will be recruited for TEP repair. Mesh fixation methods spiral tacks glue is randomly assigned to one side to the groin and Histoacryl synthetic glue to the other side. Patients will be followed up regularly for up to 6 months by an independent clinical nurse was blinded to the mesh fixation assignment. The patients are also blinded to the the mesh fixation assignment. The post operative pain score, peri-operative complication, and recurrences will be documented.

Eligibility Criteria:
Inclusion Criteria:

* Patients present with clinical bilateral inguinal hernias And feasible for general anesthesia

Exclusion Criteria:

* Patient preference for either fixation technique, refusal to participate, previous major lower abdominal surgery, concomitant surgical procedures other than hernia repair, and history of allergy to Histoacryl.
Reducing Sedentary Time in Obese Adults

Greater time spent in sedentary behaviors, independent of physical activity level, can increase risk of morbidity and mortality. Objective assessments indicate that bariatric surgery patients spend large amounts of time in sedentary behaviors. The present study is the first to test whether a mobile health (mHealth) approach that employs widely adopted smartphone technology to monitor and modify sedentary behaviors as they occur is a feasible and acceptable method of reducing sedentary time in these patients and other obese populations.


Eligibility Criteria:
Inclusion Criteria:

* Bariatric surgery patients and other obese individuals will be considered
* Body mass index \>= 30 kg/m2

Exclusion Criteria:

* Report being unable to engage in daily activities and walk continuously for \>= 10 minutes without assistance
* Are currently involved in a physical activity intervention.
* Are unable to read or understand the study materials
* Are currently taking medications that cause dizziness and/or feeling faint when sitting or standing.
* Report any condition that in the opinion of investigators would preclude adherence to the intervention protocol including plans to relocate, history of substance abuse or other significant psychiatric problems, or terminal illness.
HIV/STD Safer Sex Skills Groups for Men in Drug Treatment Programs - 1

The purpose of this study is to evaluate a five-session Human Immunodeficiency Virus/Acquired Immune Deficiency Disease (HIV/AIDS) group therapy designed specifically for heterosexual men. This therapy is compared to standard HIV/AIDS education, which generally consists of a single session of HIV education.


Eligibility Criteria:
All adult males age 18 and above in drug abuse treatment at participating Community Treatment Providers will be invited to participate.
The Effect of Exercise and Nicotinamide Riboside Muscle Health and Insulin Resistance in Survivors of Childhood Cancer

This trial studies the effect of exercise and nicotinamide riboside on muscle health and insulin resistance in adult survivors of childhood cancer with prediabetes (elevated blood sugar level that is not high enough to be considered diabetes). Nicotinamide riboside is a dietary supplement which is similar to vitamin B3. Information collected in this study may help the future development of regimens to improve metabolic outcomes such as muscle health and insulin resistance (when the body is not normally responding to insulin) in childhood cancer survivors.

PRIMARY OBJECTIVE:

I. Evaluate the feasibility of conducting a home exercise and nutrition intervention in childhood cancer survivors (CCS) with a history of prediabetes.

EXPLORATORY OBJECTIVES:

I. Describe the association between patient demographics and treatment exposures and subsequent hyperglycemia and skeletal muscle health in childhood cancer survivors.

II. Describe the effect of exercise with or without nicotinamide riboside (NR) on hyperglycemia and skeletal muscle health in CCS with a history of prediabetes.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients complete 18 home exercise sessions over 30 minutes each, 3 days per weeks for 6 weeks.

ARM II: Patients complete home exercise as in Arm I. Patients also receive nicotinamide riboside orally (PO) daily for 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* History of childhood cancer
* History of prediabetes (HbA1c 5.7-6.4%)
* In remission at time of enrollment
* Time between completion of cancer-directed therapy and study entry: \>= 6 months
* At least 18 years of age at time of enrollment
* Able to access online exercise program at home
* Ability to tolerate the prescribed resistance exercise program
* English-speaking
* Able to understand and sign the study specific informed consent form (ICF)

Exclusion Criteria:

* Taking a nicotinamide adenine dinucleotide (NAD)+ precursor in the two weeks prior to enrollment
* Currently taking medication for hyperglycemia or diabetes
* Females who are pregnant or planning to become pregnant
* Currently recovering from an injury
* Contraindication to magnetic resonance imaging (MRI)
* Pacemaker
YMCA Diabetes Prevention Program for the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD)

This study is for men and women have been diagnosed with non-alcoholic fatty liver disease (NAFLD) and will consequently participate in the YMCA's Diabetes Prevention Program.

This study is for men and women who participate in the YMCA's Diabetes Prevention Program (YMCA's DPP) and have been diagnosed with non-alcoholic fatty liver disease (NAFLD). There will be no administration of study drug. The purpose of this study is to see if participation in the YMCA's DPP will result in weight loss and improvement in the liver in patients with fatty liver disease.

Eligible participants will visit Weill Cornell Medical College's Gastroenterology and Hepatology clinic to review their medical history, physical examination, complete a survey, and conduct imaging tests (FibroScan, ultrasound, DEXA scan) for their baseline visit. Blood will be collected as part of standard practice. An additional blood sample will be collected for storage. Subjects will complete 9 out of 16 weekly sessions. The YMCA's program will be conducted at Weill Cornell Medical College Gastroenterology and Hepatology Division.

Participants will be in the YMCA program for about 1 year and an additional 1 year in the long-term follow-up for data collection.

Participants will be compensated for their time.

Key eligibility criteria:

1. Men and women over 18 years of age.
2. Diagnosed with Non-alcoholic Fatty liver disease.
3. Detailed eligibility reviewed when contacting the study team.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18
2. Must provide signed written informed consent and agree to comply with the study protocol
3. BMI \>25 kg/m²
4. Hepatic steatosis by imaging or histology
5. Baseline Fibroscan CAP score \> 238 dB/m
6. ALT \>19IU/mL in females, ALT \>30IU/mL in males

Exclusion Criteria:

1. Unclear etiology of liver disease
2. Competing etiologies for hepatic steatosis
3. Co-existing causes of chronic liver disease according to standard diagnostic testing including, but not restricted to:

   * Positive hepatitis B surface antigen
   * Positive hepatitis C virus RNA
   * Suspicion of drug-induced liver disease
   * Alcoholic liver disease
   * Autoimmune hepatitis
   * Wilson's disease
   * Hemochromatosis
   * Primary biliary cholangitis or primary sclerosing cholangitis
4. Known or suspected hepatocellular carcinoma
5. Current or recent history (\<5 years) of significant alcohol consumption. For men, significant consumption is defined as \>30g of alcohol per day. For women, it is defined as \>20g of alcohol per day.
6. Compensated and decompensated cirrhosis (clinical and/or histologic evidence of cirrhosis). NASH patients with fibrosis stage = 4 according to the NASH CRN fibrosis staging system are excluded.
7. Pregnant females
8. Mental instability or incompetence, such that the validity of the informed consent or ability to be compliant with the study is uncertain
9. Inability to perform Fibroscan and/or invalid study
Efficacy and Safety of Cold Versus Hot Snare Polypectomy for Removal of 4-10 mm Pedunculated Colorectal Polyps

This was a non-inferiority randomized controlled trial designed to compare the efficacy and safety of cold versus hot snare polypectomy for the removal of 4-10 mm pedunculated colorectal polyps. The primary outcome was delayed postpolypectomy bleeding. The secondary outcomes included immediate postpolypectomy bleeding, procedure time, en bloc resection, complete histologic resection, use of haemostatic clips and perforation rate.


Eligibility Criteria:
Inclusion Criteria:

1. 18-80 years old, male and female
2. Proposed colonoscopy and colonoscopy detection of at least one 4-10 mm pedunculated colorectal polyp

Exclusion Criteria:

1. Contraindication to colonoscopy or polypectomy
2. Use of antiplatelet or anticoagulant drugs within 1 week before polypectomy
3. Alarming signs and symptoms of colorectal cancer (blood in stool, black stool, unexplained anaemia and weight loss, abdominal mass, positive rectal examination; or imaging and laboratory tests highly suspicious for colorectal cancer) or endoscopic manifestations of polyps highly suspicious for high-grade intraepithelial neoplasia or carcinoma
4. Comorbidity with inflammatory bowel disease, colonic polyposis, or active gastrointestinal bleeding
5. Inadequate bowel preparation
6. Pregnant or lactating women
7. Failure to sign the informed consent form
8. Patients deemed ineligible by investigators to enrol in the trial
Exercise Protocols in Postural Balance Of Elderly Women

To determine and compare the effects of a training program with Pilates and Facilitation Neuromuscular Proprioceptive on balance and function in elderly women.

Older women living in Teresina and participating in a local church project called "Pão dos Pobres" were randomly divided into three groups: Proprioceptive Neuromuscular Facilitation (PNFG), Pilates (PG) and Control(CG). Intervention: A training program (50 minutes session) was performed with the PNFG and the PG, 3 times a week, for 4 weeks. The elderly in CG suffered no intervention and continued with their daily activities. Main Outcome Measures: The stabilometric parameters, Berg Balance Scale score, functional reach test and Timed Up and Go test (TUG test) were measured before and one month after, in all participants.

Eligibility Criteria:
Inclusion Criteria:

* All the subjects were between 60 and 80 years old,
* sedentary and healthy

Exclusion Criteria:

-Orthopedic, cardiovascular, vestibular, psychological, neurological or any other impairment that would not allow the execution of all study tasks
Study to Compare the Effect of Treatment With Carbidopa/Levodopa/Entacapone on the Quality of Life of Patients With Parkinson's Disease. This Study is Not Recruiting in the United States

This study examines the effect of treatment of levodopa/entacapone on quality of life, as measured by the Parkinson's Disease-Questionnaire 8 (PDQ-8), in Parkinson's disease patients with no or minimal, non-disabling motor fluctuations.

This study examines the effect of treatment of levodopa/entacapone on quality of life, as measured by the Parkinson's Disease-Questionnaire 8 (PDQ-8), in Parkinson's disease patients with no or minimal, non-disabling motor fluctuations. Treatment with carbidopa/levodopa/entacapone will be compared with treatment with standard formulation levodopa/carbidopa.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of idiopathic Parkinson's disease exhibiting at least 2 or 3 symptoms
* Motor functions must be regarded as non-disabling by the patient

Exclusion Criteria:

* History, signs or symptoms suggesting the diagnosis of atypical or secondary parkinsonism
* History of dyskinesia
* Previous or current use of entacapone or tolcapone
* Unstable Parkinson's disease patients requiring/receiving regimens of levodopa
* Subjects taking levodopa/DDCI controlled release or extended release formulations
The Validity of Forced Expiratory Maneuvers in Ataxia Telangiectasia Studied Longitudinally

Rationale: Forced spirometry maneuvers are not routinely performed in patients with Ataxia Telangiectasia (A-T), even though they suffer from respiratory illnesses.

Objectives: To study the feasibility and validity of forced spirometry in A-T patients.

Methods: Patients will perform spirometry during clinical visits. Parameters studied will be technical quality, relation to predicted values, age, pulmonary illness, body mass index, mutational status and mutation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with proven Ataxia Telangiectasia

Exclusion Criteria:

* inability to perform spirometry
Pharmacokinetics of Imipenem During Ex Vivo Lung Perfusion (EVLP)

Ex vivo lung perfusion (EVLP) is an established strategy to evaluate and optimize high-risk donor lungs that would otherwise be rejected for transplantation mainly due to the presence of edema or infection. Extracorporeal circuits may negatively affects pharmacokinetic (PK) of several drugs including antibiotics, thus exposing patients to risk of therapeutic failure or drug toxicity. The investigators set out to examine the concentration of imipenem in lung perfusate and in lung biopsy during EVLP, and its clinical impact.


Eligibility Criteria:
Inclusion Criteria:

1. Best PaO2/FiO2 \< 300 mmHg;
2. Pulmonary edema on chest X-Ray;
3. Poor inflation or deflation at visual inspection;
4. Need for blood transfusion of more than 10U;
5. Maastricht category III/IV

Exclusion Criteria:

1. Diagnosis of pneumonia;
2. severe mechanical injury;
3. gross gastric aspiration
Orthotic Treatment of Diabetic Foot Ulcers

The United States Department of Veterans Affairs spends an estimated $1.5 billion a year on healthcare for patients with diabetes. The prevalence and complications of diabetes increase with age. Therefore, with the aging of the US and Veteran populations, there is an expectation of increased healthcare costs associated with treating diabetes and the associated complications of this disorder. One common complication is the diabetic foot ulcer. Diabetic foot ulcers are expensive to treat, can take a long time to heal and result in a decrease in patient quality of life. Patients remain susceptible to developing more foot ulcers over time. The goal of this project is to reduce the time it takes to heal a diabetic foot ulcer, increase the time between episodes of ulceration and improve the quality of life for diabetic foot ulcer patients.


Eligibility Criteria:
Inclusion Criteria:

* Veteran patients prescribed an orthotic walking boot for treatment of their diabetic foot ulcer will be eligible to participate in the study.

Exclusion Criteria:

* Veteran patients with amputation proximal to the tarsometatarsal joint, with a Meggitt-Wagner score of 4 or more, with severe infection, with non-ambulatory status or without palpable pedal pulse will be excluded
* All patients will be screened for severe cognitive impairment with the 15 point Brief Interview for Mental Status (BIMS)

  * scores between 12 and 8 will indicate need for extra efforts to support comprehension of instructions, and patients with scores of 7 or less will be excluded
Pedialyte or Gatorade for Viral Gastroenteritis in Adults: a Randomized, Controlled Trial

Background: Pedialyte and Gatorade are advocated for the treatment of dehydration in viral gastroenteritis, but there is limited evidence to support their use.

Objective: To examine the efficacy, safety and palatability of Pedialyte, Gatorade, and a New Oral Rehydration Solution (NS).

Design: Randomized double blind. Setting: Inpatient, community hospital. Patients/Interventions: 75 consecutive adult patients (m/f=44/33) admitted with viral gastroenteritis were randomized to receive Gatorade, Pedialyte or NS for 48 hours. A yogurt/rice diet was allowed ad libitum.

Measurements: Stool and urine output, electrolytes, fluid intake, body weight, hematocrit and palatability of solutions.

Limitations: Smaller sample size and higher drop out (20%).


Eligibility Criteria:
Inclusion Criteria:

* Subjects were included if they had mild-to-moderate diarrhea, with mildly sunken eyes and a clinical assessment of dehydration of less than 5%, a serum sodium concentration between 130-150 mEq/L, adequate general health and nutrition, a BUN/creatinine ratio of \>20 and with a normal pulse rate for age and degree of fever and adequate skin turgor

Exclusion Criteria:

* Patients were excluded if they had hyperthermia (\>39.0º C), serum sodium \>150 mEq/L or \<130 mEq/L, white cell count \>15,000, bloody diarrhea (dysentery), abnormal cardiovascular or renal function or an underlying metabolic or nutritional disorder and most importantly, if the clinical assessment of dehydration was \>7% that suggested a need for intravenous fluids.
Flumatinib Efficacy and Safety for New Diagnosed Chronic Phase Chronic Myeloid Leukemia

The overall survival (OS)of Chronic myeloid leukemia (CML) has been significantly improved since the advent of Tyrosine kinase inhibitors (TKIs) .Nevertheless, there still exists a amount of patients who has poor response or intolerance for TKI drugs( Imatinib, dasatinib, nilotinib). Flumatinib has been shown to be a more potent inhibitor of BCR-ABL1 tyrosine kinase than imatinib,and it aslo has better security when compared to other TKIs(Imatinib, dasatinib, nilotinib).It will be a better chioce for CML patients.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old, both male and female;
2. New Diagnosed Chronic Phase Chronic Myeloid Leukemia.
3. Within half a year after diagnosis of CML;
4. Previous TKIs treatment was less than 2 weeks;
5. The pregnant test of female patients was negative (within 7 days before medication before enrollment);
6. Informed consent of the patient or his legal representative

Exclusion Criteria:

1. T315I mutation is known to exist;
2. Rare atypical transcript types that cannot be standardized internationally;
3. Received TKI drugs for more than 2 weeks before enrollment;
4. Received interferon therapy for more than 3 months before enrollment;
5. Received other anti-CML drugs (except hydroxyurea) for more than 2 weeks or surgical treatment (including hematopoietic stem cell transplantation)
6. patients who participate in other clinical studies at the same time;
7. patients who having had major surgery or not recovered from surgery within 4 weeks;
8. patients who having history of malignant tumor
9. Woman who is pregnant or nursing
10. Eastern Cooperative Oncology Group Physical Performance Status Score (ECOG PS) \> 3;
11. Patients known to be allergic or contraindicated to the study drug (APIs and/or excipients).
12. A clear history of neurological or psychiatric disorders, including epilepsy or dementia
Gastric Emptying of Water in Obese Term Pregnant Women

It has been believed that the risk of pulmonary aspiration in term pregnant women is increased, and should be considered that all term pregnant women to have "full stomach". Recently, gastric ultrasound has been adopted as a useful tool for quantitative and qualitative assessment of stomach before anesthesia, and predict the risk of pulmonary aspiration.

Although, both the obesity and pregnancy are known to be the risk of pulmonary aspiration, it is suggested in the American Society of Anesthesiology fasting guidelines, that the same fasting time should be applied in the obese and non-obese parturients. However, this was based on one study done in a small (10) numbers of volunteers.

Therefore, the investigators aimed to compare the gastric antral cross-sectional area in both obese and non-obese term pregnant women, scheduled for elective cesarean section.

This study is a prospective, observational study. 42 term (≥37 weeks) pregnant, non-laboring adult women scheduled for cesarean delivery will be included in the study. They will be allowed to drink water freely, until 2 hours before the anesthesia. Gastric ultrasound will be performed in 21 non-obese women, and 21 obese women. The obesity is defined by the body mass index at term.

Eligibility Criteria:
Inclusion Criteria:

* Non laboring, term (≥37 weeks) pregnant women
* Scheduled for elective cesarean section
* aged ≥ 18 years old
* American Society of Anesthesiology physical class 1-3

Exclusion Criteria:

* multigestational pregnancy
* diagnosed for delayed gastric emptying (GERD, gastrointestinal disease)
* diabetes