bioihbjkbjnl/mcl2 huggingface dataset:
Response of Cardiac Resynchronization Therapy Optimization With Ventricle to Ventricle Timing in Heart Failure Patients
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: Simultaneous VV Pacing; Sequential VV Pacing
Intervention description: Right ventricular and left ventricular pacing delivered simultaneously.; Right ventricular and left ventricular pacing delivered sequentially.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 816.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to evaluate the benefit of interventricular (V-V) delay
      optimization in reducing the non-responder rate in patients with cardiac resynchronization
      defibrillator (CRT-D) devices. The primary endpoint of this study is CRT responder rate.

      For patients enrolled with new CRT-D systems, patients are considered non-responders if BOTH
      of the following requirements are fulfilled:

        -  < 10% improvement in 6-minute hall walk, and

        -  no class improvement or worsening in New York Heart Association (NYHA) scale.

      For those receiving CRT-D devices as replacements of older CRT-D systems, patients are
      considered non-responders if BOTH of the following requirements are fulfilled:

        -  > 1 heart failure (HF) related hospitalization, and

        -  no class improvement or worsening in NYHA scale.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has a standard indication for a CRT-D.

          -  Patient has the ability to complete a 6-minute hall walk with the only limiting factor
             to be fatigue or shortness of breath.

          -  Patient is geographically stable and willing to comply with the required follow-up
             schedule.

          -  Prior to 1 month of randomization, patient's HF medications are maintained stable and
             remain stable throughout the study.

          -  Patients requiring a CRT-D replacement must comply with BOTH of the following:

               -  > 1 HF related hospitalization

               -  No class improvement or worsening in NYHA scale

        Exclusion Criteria:

          -  Patient's life expectancy is less than 12 months.

          -  Patient has had cardiac surgery within 6 months of enrollment.

          -  Patient has an epicardial ventricular lead system.

          -  Patient is less than 18 years old.

          -  Patient is pregnant.
Baclofen as Add-On to Standard Treatment of Alcohol- Dependent Patients
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Intervention: Baclofen; Control group
Intervention description: Baclofen 50mg per day for 12 weeks and psychosocial intervention; psychosocial intervention and placebo for 12 weeks
Intervention MeSH terms: Baclofen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Baclofen; Alcohol; Baclofen as add-on to standard treatment of alcohol

Summary:

      This is a study of Baclofen as an add-on to standard treatment for alcohol-dependent
      patients.
    

Eligibility criteria:

        Inclusion Criteria:

          1. ICD-10 diagnosis of alcohol dependence (World Health Organization, 1993);

          2. Seeking treatment with the aim to stop alcohol consumption;

          3. Age ranging from 18 to 60 years;

          4. Last alcohol intake reported in the 24 h preceding observation;

          5. Presence of a referred family member;

          6. Written informed consent provision.

        Exclusion Criteria:.

          1. Serious hepatic, kidney, lung, neurological and cardiovascular, diseases);

          2. Suicide risk, acute psychosis, severe depression, organic brain syndromes;

          3. Dependence on psychoactive substances other than nicotine.
The CALIBER Study Randomized Controlled Trial of LINX Versus Double-Dose Proton Pump Inhibitor Therapy for Reflux Disease
Condition: GERD Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux
Intervention: Omeprazole; LINX Reflux Management System
Intervention MeSH terms: Omeprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 152.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Esophageal Reflux; Gastric Acid Reflux Disease; Heartburn

Summary:

      This study compares mechanical sphincter augmentation (LINX Reflux Management System) to
      double-dose proton pump inhibitors (PPIs) for the management of reflux symptoms related to
      gastroesophageal reflux disease (GERD).
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Patient seeks consultation for lack of satisfactory symptom response to once daily
             PPIs.

          2. Age≥ 21 years old.

          3. Abnormal distal esophageal pH determined by total % time pH <4 or DeMeester Score.
             Testing to be completed off GERD medications for at least 7 days, with the exception
             of antacids, which may be taken up until the morning of assessment.

          4. Suitable surgical candidate (i.e. is able to undergo general anesthesia and
             laparoscopic surgery).

          5. Patient has provided written informed consent for participation in the randomized
             study.

        Key Exclusion Criteria:

          1. Currently taking double-dose PPIs (twice daily dosing).

          2. Hiatal hernia >3cm as determined by endoscopy.

          3. Distal esophageal motility (average of sensors 3 and 4) is less than 35 mmHg
             peristaltic amplitude on wet swallows or <70% (propulsive) peristaltic sequences.

          4. Esophagitis Grade C or D (Los Angeles classification).

          5. Body mass index >35.

          6. Diagnosed with an esophageal motility disorder LES.

          7. Esophageal stricture or gross esophageal anatomic abnormalities

          8. History of/or known Barrett's esophagus.

          9. Suspected or known allergies to titanium, stainless steel, nickel or ferrous
             materials.
Prospective Study of Efficacy of Intra-muscular Vitamin D3 in Tropical Calcific Pancreatitis
Condition: Pancreatitis, Chronic
MeSH terms: Pancreatitis; Pancreatitis, Chronic
Intervention: Vitamin D3 (Cholecalciferol)
Intervention description: Arm 1 - Intramuscular vitamin D3 3,00,000 Units single dose
Arm 2 - Intramuscular vitamin D3 6,00,000 Units single dose
Arm 3 - Oral vitamin D3 500 Units/day for 6 months
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Tropical calcific pancreatitis; Tropical chronic pancreatitis; Chronic pancreatitis; Vitamin D; Vitamin D deficiency; Cholecalciferol; Intramuscular vitamin D3

Summary:

      The purpose of this study is to determine the efficacy of 2 different doses of intramuscular
      (IM) vitamin D3 as compared to an oral replacement dose in normalizing vitamin D levels in
      the blood of patients with tropical calcific pancreatitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of tropical calcific pancreatitis established by history of
             abdominal pain or diabetes and evidence on ultrasound or CT scan of pancreatic ductal
             dilatation and intra-ductal stones

        Exclusion Criteria:

          -  History of alcohol intake or any secondary cause for chronic pancreatitis
             (hypercalcemia, hypertriglyceridemia, biliary tract stones)

          -  History of hepatic or renal dysfunction or of current intake of drugs such as
             steroids, anticonvulsant drugs
VERtebral Fracture Treatment Comparisons in Osteoporotic Women
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal; Spinal Fractures
Intervention: Teriparatide; Risedronate; Placebo; Calcium; Vitamin D
Intervention description: Administered SC; Administered orally; Teriparatide arm placebo administered orally.
Risedronate arm placebo administered SC.; Administered orally; Administered orally
Intervention MeSH terms: Vitamin D; Teriparatide; Risedronic Acid; Calcium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1366.0
Sex: Female
Minimum age: 45 Years
Healthy volunteers: No
Keywords: Bone Loss; Vertebral fractures

Summary:

      The primary purpose of participation in this study is to answer whether teriparatide is
      superior to risedronate in reducing the occurrence of new vertebral fractures during 24
      months of therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal women with osteoporosis, as defined by low bone mineral density (BMD),
             i.e. anterior-posterior lumbar spine, total hip or femoral neck BMD ≥1.5 standard
             deviations below the average BMD for young, healthy, non-Hispanic, Caucasian women

          -  A minimum of 2 moderate or 1 severe vertebral fragility fractures (confirmed by
             central reader) were required

        Exclusion Criteria:

          -  Increased risk of osteosarcoma

          -  History of unresolved skeletal diseases that affect bone metabolism

          -  History of atypical subtrochanteric or diaphyseal femoral fractures

          -  Abnormally high or low calcium levels

          -  Abnormally high parathyroid hormone (PTH) levels

          -  Severe vitamin D deficiency

          -  Abnormal thyroid function not corrected by therapy

          -  History of malignant neoplasms in the last 5 years

          -  Active liver disease, clinical jaundice

          -  Significant impairment of hepatic or renal function

          -  History of nephro- or urolithiasis

          -  Previous or planned kypho- or vertebroplasty

          -  Active or risk for osteonecrosis of the jaw

          -  Active or recent history of upper gastrointestinal disorders

          -  Unable to stand or sit in the upright position for at least 30 minutes
A Diabetes Study to Treat A Population Previously Not at Target
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus
Intervention: Rosuvastatin
Intervention description: Oral
Intervention MeSH terms: Rosuvastatin Calcium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 598.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: diabetes; type 2

Summary:

      This study will assess if customizing the start dose of rosuvastatin appropriate for the
      degree of LDL-C reduction required, would achieve LDL-C target of ≤ 2.0 mmol/L quickly with
      either no titration or just one titration step after 6 weeks of therapy in type 2 diabetic
      patients previously treated with another statin and not at LDL-C targets.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Type 2 diabetes

          -  Previously treated with a commonly accepted start dose of a statin for the last 4
             weeks prior to study entry

          -  Fasting LDL-C concentration of > 2.0 mmol/L (and ≤ 5.0 mmol/L) (in the past 3 months)

          -  History of serum TG level of ≤ 4.6 mmol/l (in the past 3 months)

        Exclusion Criteria:

          -  If currently receiving therapy with any statin at a dose higher than listed

          -  Rosuvastatin (current use)

          -  Fibrates, niacin or resins that was not discontinued a minimum of 2 months prior to
             enrolment.

          -  Type 1 diabetes; glycated haemoglobin (HbA1c) > 9.0%

          -  Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥ 1.5 × upper
             limit of normal (ULN) (in the past 2 months)

          -  Resting diastolic or systolic blood pressure of > 95 mmHg or > 180 mmHg, respectively
             (in the past 2 months)

          -  Unexplained serum creatine kinase (CK) level > 3 × ULN (in the past 2 months).
Ropinirole for the Treatment of Muscle Cramps in Patients With Cirrhosis
Condition: Muscle Cramp; Cirrhosis
MeSH terms: Muscle Cramp; Liver Cirrhosis; Spasm; Fibrosis
Intervention: Vitamin E; Ropinirole; Muscle cramp survey
Intervention description: Patients will take 400 IU vitamin E nightly for 3 months.; Patients will take 0.5mg ropinirole nightly for 3 months.; Patients will complete a survey of muscle cramp frequency and severity at baseline, 3 months, and 6 months.
Intervention MeSH terms: Vitamin E; Ropinirole
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The investigator's aim is to compare the efficacy of Ropinirole (Requip) to vitamin E in the
      treatment of muscle cramps in cirrhotic patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients at least 18 years of age in the Vanderbilt Medical Center Hepatology Practice

          -  diagnosis of cirrhosis

          -  Self report regular muscle cramping

        Exclusion Criteria:

          -  Patients without cirrhosis

          -  Patients under the age of 18

          -  Pregnant women
Vitamin D Supplementation for Treatment of Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: Vitamin D3; Placebo
Intervention description: Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months; A placebo loading dose will be given followed by 2 placebo tablets daily for 6 months.
Intervention MeSH terms: Vitamin D; Cholecalciferol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Vitamin D; Systolic failure; Genomics; Biomarkers; Exercise; Quality of Life

Summary:

      The central objective of this proposal is to establish that vitamin D supplementation in
      heart failure patients with low vitamin D levels will have improved outcomes compared to
      placebo. In addition the investigators will also evaluate the role of genetics in regard to
      vitamin D and heart failure. The investigators will be evaluating what is currently a novel
      approach of identifying patients with low vitamin D and treating this low vitamin D level.
      The investigators will be able to evaluate the importance of vitamin D supplementation in
      these patients and the role of genetics on our defined outcomes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HF patients with LV systolic dysfunction of ischemic or non-ischemic origin and an
             LVEF <40% using nuclear ventriculography or echocardiography within the last 6 months.

          -  Attempts should have been made at optimizing medical therapy and the participant
             should be stable on these medications for at least 3 months.

          -  Patients with a 25(OH)D level between 10-25 ng/ml

        Exclusion Criteria:

          -  Inability to give informed consent

          -  Patients with sarcoidosis or other granulomatous disease that can alter vitamin D
             metabolism

          -  Patients with primary valvular HF, hypertrophic cardiomyopathy, and drug-induced HF

          -  Renal dysfunction defined as serum creatinine > 2.5 mg/dl

          -  Pregnant women

          -  Patients <18 years of age

          -  Patients on vitamin D supplementation
Metformin Postpartum for GDM RCT for Reduced Weight Retention
Condition: Diabetes, Gestational
MeSH terms: Diabetes, Gestational
Intervention: Metformin; Placebo
Intervention description: Subjects will receive metformin 850 mg PO daily for 7 days, then metformin 850mg PO twice a day for the next 5 weeks; Subjects will receive a placebo (similar in size, taste, color) once daily for 7 days, then twice daily for the next 5 weeks.
Intervention MeSH terms: Metformin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 114.0
Sex: Female
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether the study drug metformin is helpful in
      reducing weight after pregnancy in women with gestational diabetes. This pilot study will
      provide information on how well women are able to take metformin postpartum, whether
      metformin increases weight loss, and whether there are any increased risks of side effects to
      you as a new mother.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postpartum women with a delivery greater than 34 weeks of pregnancy

          -  Between the ages of 18 to 49 years

          -  Women with a diagnosis of gestational diabetes mellitus (either treated with insulin,
             oral hypoglycemic agent or diet-controlled) after 24 weeks in most recent pregnancy
             based on a confirmatory 3 hour glucola test (based on either the Carpenter and
             Coustan's of the Diabetes Task Force criteria)

        Exclusion Criteria:

          -  women with pre-gestational diabetes mellitus (either Type I or Type II DM)

          -  women unable to tolerate metformin based on patient history

          -  women who will be discharged hom eon insulin or oral hypoglycemic agent in the
             immediate postpartum period

          -  women with a BMI <25 kg/m²
A Time-motion Study Comparing Self- to Nurse-vaccination With Influenza Vaccine
Condition: Influenza; Vaccination Site Reactions (HT)
MeSH terms: Influenza, Human
Intervention: Intanza; Vaxigrip
Intervention description: Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere; Influenza vaccine, trivalent, split-virion, inactivated, approved for the 2012-2013 influenza season in the northern hemisphere
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 868.0
Sex: All
Minimum age: 18 Years
Maximum age: 69 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: influenza; vaccine; administration

Summary:

      The investigators hypothesize that people working in an acute care hospital setting will be
      able to successfully self-administer the intradermal vaccine (Intanza) in less time than
      nurse-administration of the regular intramuscular influenza vaccine (Vaxigrip). The
      investigators also hypothesize that people administering the intradermal vaccine for the
      second time will take less time to successfully administer than people administering it for
      the first time.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Medically stable men or women 18 to 69 years of age (inclusive)

          -  Work in any capacity (including physicians and midwives with admitting privileges),
             volunteer, or student at participating hospital

          -  Able to read, understand, and respond to questionnaires

          -  Able to read, understand, and sign an informed consent form

          -  Available for follow-up for 8 days post-vaccination

          -  Participants in Part B (repeat administration) of the study must also have
             participated in the previous randomized control trial of self- versus
             nurse-administered intradermal influenza vaccine and must have attempted to
             self-administer the vaccine

        Exclusion Criteria:

          -  Already received 2012-13 influenza vaccine

          -  History of a severe reaction following influenza vaccination

          -  Known allergy to components of study vaccines (Intanza® or Vaxigrip®)

          -  History of Guillain-Barré Syndrome (GBS) within 8 weeks following influenza
             vaccination

          -  Acute febrile illness (>37.9ºC orally) within the past 48 hours (participation may be
             deferred until recovery for these subjects)
A Trial of Oral Misoprostol for Labor Augmentation
Condition: Labor Augmentation
Intervention: Misoprostol; Oxytocin
Intervention description: 75 micrograms orally every 4 hours for up to 2 doses.; Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital
Intervention MeSH terms: Misoprostol; Oxytocin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 350.0
Sex: Female
Minimum age: 16 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Labor augmentation; Oral misoprostol

Summary:

      This is a prospective, randomized, controlled trial designed to examine the efficacy of oral
      misoprostol for labor augmentation compared to a standard regimen of intravenous oxytocin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical decision to augment labor

          -  Gestational age > than or equal to 36 weeks

          -  Singleton gestation

          -  Cephalic presentation

          -  Reassuring fetal heart rate tracing

          -  Cervical dilation between 4 and 8 cm

          -  Ruptured membranes with clear amniotic fluid

          -  Intrauterine pressure catheter in place

          -  Less than 200 MVUs in a 10 minute period

          -  5 or fewer contractions in a 10 minute period

          -  English or Spanish speaking patient

        Exclusion Criteria:

          -  Non-reassuring fetal heart rate tracing at time of enrollment

          -  Meconium stained amniotic fluid

          -  Previous uterine incision

          -  Maternal fever (defined as greater than 37.9 C)

          -  Known fetal anomalies

          -  Placenta previa or unexplained vaginal bleeding

          -  Estimated fetal weight of 4,500 grams or more

          -  Abnormal maternal bony pelvis

          -  Grandmultiparity