bioihbjkbjnl/mcl2 huggingface dataset:
Advanced Medical Therapy Versus Advanced Medical Therapy Plus Bariatric Surgery for the Resolution of Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2; Obesity
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The aim of the study is to compare the relative clinical outcomes between advanced medical
      therapy alone or advanced medical therapy combined with bariatric surgery [either Roux-en-Y
      gastric bypass (RYGBP) or laparoscopic sleeve gastrectomy] in patients with type 2 diabetes
      and a body mass index (BMI) between 27 and 43 kg/m2. The study will examine the short and
      long term effects of each intervention on biochemical resolution of diabetes, diabetic
      complications, and end-organ damage.
    


Intervention name(s): Gastric bypass; Sleeve Gastrectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Roux-en-Y gastric bypass; Laparoscopic sleeve gastrectomy
Other intervention name(s): RYGB; SG
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 2; Obesity
Single-Photon Emission Computed Tomography, Computed Tomography Lymphoscintigraphy, and Intensity-Modulated Radiation Therapy in Treating Patients Who Have Undergone Surgery for Stage I or Stage II Breast Cancer
Condition: Breast Cancer; Lymphedema
MeSH terms: Breast Neoplasms; Lymphedema
Study type: Interventional
Phase: Early Phase 1

Summary: 
      RATIONALE: Diagnostic procedures, such as single-photon emission computed tomography and
      computed tomography lymphoscintigraphy, may help lower the dose of radiation therapy after
      surgery, and help prevent lymphedema.

      PURPOSE: This clinical trial is studying single-photon emission computed tomography and
      computed tomography lymphoscintigraphy followed by intensity-modulated radiation therapy to
      see how well they work in treating patients who have undergone surgery for stage I or stage
      II breast cancer.
    

Detailed description: 
      OBJECTIVES:

        -  To assess the feasibility of integrating Philips Precedence SPECT/CT® images with GE
           PET/CT Fusion software to reduce radiation dosimetry delivered to lymph nodes draining
           the arm in patients after surgery for stage I or II breast cancer.

        -  To examine the differences in radiation dosimetry in these patients using 3-D conformal
           radiotherapy with vs without the Philips Precedence SPECT/CT®.

        -  To compare reduction in lymph node radiation dosimetry in these patients using single
           photon emission computed tomography (SPECT) and computed tomography (CT) with 3-D
           conformal radiotherapy vs intensity-modulated radiotherapy.

      OUTLINE: Patients receive filtered technetium Tc 99m sulfur colloid (TcSC) intradermally and
      undergo single photon emission computed tomography (SPECT) and computed tomography (CT)
      imaging at the time of TcSC and 2 hours after injection. Patients then undergo
      intensity-modulated radiotherapy of the whole breast, including the low axilla and lymph
      nodes identified by the Phillips Precedence SPECT/CT® at a dose determined by computer
      analysis of the imaging information.

      Patients complete a lymphedema screening questionnaire at baseline and at 12 and 24 months
      after treatment.
    

Intervention name(s): screening questionnaire administration; computed tomography; lymphoscintigraphy; single photon emission computed tomography; intensity-modulated radiation therapy; technetium Tc 99m sulfur colloid
Intervention type(s): Other; Procedure; Procedure; Procedure; Radiation; Radiation
Intervention MeSH terms: Technetium Tc 99m Sulfur Colloid
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: lymphedema; stage I breast cancer; stage II breast cancer
Left Ventricular and Endothelial Function in Preeclampsia
Condition: Preeclampsia
MeSH terms: Pre-Eclampsia
Study type: Observational

Summary: 
      The purpose of this study is (1) to examine whether the left ventricular function is impaired
      in women with preeclampsia relative to healthy pregnant controls, (2) to examine whether the
      endothelial function is impaired in women with preeclampsia relative to healthy pregnant
      controls, and (3) to examine whether there is a post partum impairment in left ventricular
      and endothelial function.
    


Observational model: Case-Control
Sampling method: Probability Sample
Study population: 
        Women with preeclampsia and women with normotensive pregnancies.
      
Biospecimen description: 
      Blood samples
BMS Reverse Cholesterol Transport (RCT) Study
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the use of radiolabeled particulate cholesterol
      administered intravenously in association with albumin, as a method to study reverse
      cholesterol transport (RCT) in humans by analyzing changes in the tracer activity in total
      plasma, lipoproteins and feces.
    

Detailed description: 
      The study will use 3H-cholesterol bound to albumin (particulate cholesterol) to assess the
      ability of HDL to transport cholesterol to the liver to be eliminated. This process is called
      Reverse Cholesterol transport and is one of the main mechanisms by which HDL protect against
      atherosclerotic cardiovascular disease. The availability of a method to assess RCT is
      important for the development of new drugs which affect RCT and may result in useful
      treatments for atherosclerosis.

      This study will evaluate the use of radiolabeled particulate cholesterol administered
      intravenously in association with albumin, as a method to study reverse cholesterol transport
      (RCT) in humans by analyzing changes in the tracer activity in total plasma and lipoproteins.
      The study population is healthy volunteers.
    

Intervention name(s): 3H-Cholesterol
Intervention type(s): Other
Intervention description(s): A single dose of 25-50 μCi 3H free cholesterol -albumin complexes (containing approximately 0.1 - 0.3 mg of cholesterol) will be administered intravenously as a slow bolus injection within 1-2 minutes.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: healthy volunteer; reverse cholesterol transport; RCT; 3H
DFN-02 Open Label Safety Study in Patients With Acute Migraine
Condition: Acute Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      A multi-center, open-label, safety study of DFN-02 for the Treatment of Acute Migraines
    


Intervention name(s): DFN-02
Intervention type(s): Drug
Intervention description(s): Active Experimental Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Dose Finding Study of Remifentanil and Propofol for Lumbar Punctures in Children
Condition: Hematologic Diseases; Neoplasms
MeSH terms: Hematologic Diseases
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will examine whether the combination of two anaesthetic medications, propofol and
      remifentanil, is suitable for short duration surgical procedures, providing a shorter
      recovery time and fewer side effects than either drug used alone.
    

Detailed description: 
      Propofol is the primary medication used by anesthesiologists at HSC to provide sedation for
      lumbar puncture. Propofol provides amnesia, anxiolysis, and hypnosis, but because propofol
      has no analgestic properties patients often respond to the pain of LP needle insertion. To
      ensure patient immobility, the dose of propofol is often increased, resulting in a duration
      of action that is excessive for lumbar puncture. Remifentanil is an ultra-short acting opioid
      which can be used to provide analgesia and sedation for short painful procedures with minimal
      residual pain. However, when used as the sole agent, remifentanil is associated with a high
      incidence of respiratory depression and/or arterial oxygen desaturation and does not provide
      amnesia or anxiolysis. The combination of propofol and remifentanil may be particularly
      suitable for short duration procedures, providing a shorter recovery time and fewer side
      effects than either drug used alone.

      The objective is to determine the minimum effective dose of remifentanil required to prevent
      movement for insertion of a lumbar puncture needle when co-administered with propofol. The
      results obtained from this study will be used in a future study of the recovery
      characteristics of propofol and remifentanil in children undergoing lumbar puncture.
    

Intervention name(s): Remifentanil; Remifentanil
Intervention type(s): Drug; Drug
Intervention description(s): The first patient in this group will receive 4 mg/kg propofol and 0.5 ug/kg respectively. The dose of remifentanil in subsequent patients will be determined by the Dixon up-and-down method.; The first patient in this group will receive 2 mg/kg propofol and 1.0 ug/kg respectively. The dose of remifentanil in subsequent patients will be determined by the Dixon up-and-down method.
Intervention MeSH terms: Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: spinal puncture; remifentanil; propofol; anesthesia; dose finding; pediatrics
Eniluracil and Surgery in Treating Patients With Primary or Metastatic Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Eniluracil may increase the effectiveness of chemotherapy by blocking tumor
      enzymes that break down chemotherapy drugs.

      PURPOSE: Randomized phase II trial to determine the effectiveness of eniluracil followed by
      surgery in treating patients who have primary or metastatic colorectal cancer.
    

Detailed description: 
      OBJECTIVES: I. Determine the enzymatic activity of dihydropyrimidine dehydrogenase (DPD) in
      peripheral blood mononuclear cells (PBMC), normal mucosa, or normal liver in patients with
      primary or metastatic colorectal cancer. II. Evaluate the ability of eniluracil to inactivate
      DPD in the tumor, PBMCs, and normal tissue in this patient population. III. Assess DPD
      recovery and uracil levels in PBMCs following surgical resection in these patients.

      OUTLINE: This is a randomized, placebo controlled study. Patients are stratified according to
      colorectal tumor (primary vs metastatic). Patients are randomized into one of two treatment
      arms. Arm I: Patients receive oral eniluracil twice daily on days -2 and -1 followed by
      surgical resection and tissue harvest on day 0. Arm II: Patients receive an oral placebo as
      in arm I followed by surgical resection and tissue harvest on day 0. Patients are followed
      weekly for 1 month.

      PROJECTED ACCRUAL: A total of 20 patients (10 per treatment arm) will be accrued for this
      study.
    

Intervention name(s): eniluracil; conventional colon surgery
Intervention type(s): Drug; Procedure
Intervention description(s): Will be given to either subject pre-operative and metastatic disease; Only if the subject is amenable to surgical resections
Other intervention name(s): 5 Fu/eniluracil (eli Lilly); 5-fu/eniluracil; 5fu/eniluraci
Intervention MeSH terms: Eniluracil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: stage I colon cancer; stage II colon cancer; stage III colon cancer; stage IV colon cancer; stage I rectal cancer; stage II rectal cancer; stage III rectal cancer; stage IV rectal cancer; recurrent colon cancer; recurrent rectal cancer
Evaluation of the Impact of Physical Reconditioning Associated With Specific Nutritional Supplementation in Obese Patients Suffering From Metabolic Syndrome
Condition: Obesity; Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      Android obesity contributes, via insulin resistance and endothelial dysfunction, to the
      development of cardiovascular atherosclerosis. It leads to poor quality of life. It is often
      associated with metabolic syndrome which includes, whatever the definitions used (National
      Education Cholesterol Program, NECP / Adult Treatment Panel III, ATP III or International
      Diabetes Federation, IDF), an increased waist measurement, an arterial high blood pressure
      and disorders of the glucide and lipid metabolism. The treatment of the current "epidemic" of
      obesity and metabolic syndrome in France (12.4 % of obese and 14 % of subjects with metabolic
      syndrome) thus requires new therapeutic approaches.

      A well-balanced diet and a daily physical activity are the indispensable requirements for the
      treatment of obesity and metabolic syndrome. It is possible to associate it to
      pharmacological agents, but the results are often partial and transient. Preliminary data
      suggest that leucine or arginine supplementation could facilitate the loss of fat mass.
      Moreover, the physical exercise has also demonstrated benefits.

      Sessions of physical reconditioning (aerobic work + muscular intensification) associated with
      a program of specific nutritional supplementation by a mixture of Leucine and Arginine (in
      the daytime) could improve the treatment of obese subjects affected by metabolic syndrome.
    


Intervention name(s): L-Leucine and L-arginine; Physical Reconditioning by a trainer
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Specific nutritional supplementation for six months by 30g per day of a mixture of amino acids (21 g L-Leucine and 9 g of L-arginine), to be distributed during each of the 3 main meals.; Physical reconditioning sessions begin with a warm-up for five minutes for the type of effort made, and then correspond to a sporting course composed of elements of strength training and / or aerobic exercises and will be completed by a return to simple stretching and general advice on managing their physical life. The duration of each session will be 45 minutes at the beginning of the protocol and then gradually increased over time to achieve 1:30 of total physical activity at the end of protocol.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obesity; metabolic syndrome; leucine; arginine; physical activity
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Modified-Release Formulations of AZD1446 After Oral Single and Repeated Doses
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess safety, tolerability and pharmacokinetics of AZD1446
      in young and elderly healthy Japanese volunteers.
    


Intervention name(s): AZD1446; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral capsule, Moderate Release; oral capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: safety; tolerability; AZD1446; AD; ADHD; Japanese
Multiple Dose-parallel-group Study of AMA0076 in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension
Condition: Glaucoma; Ocular Hypertension; Eye Disease
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Eye Diseases; Ocular Hypertension; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this parallel group study is to evaluate the safety, tolerability and
      efficacy of AMA0076 in reduction of intraocular pressure in subjects with primary open-angle
      glaucoma or ocular hypertension.
    


Intervention name(s): AMA0076; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Prevention of Dialysis Catheter Malfunction With Prophylactic Use of a Taurolidine Containing Urokinase
Condition: Patency; Infection
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of our study is to investigate whether the substitution of the standard locking
      solution with a locking solution containing taurolidine and urokinase weekly (Taurolock ™ U
      25,000 - www.taurolock.com ) reduces the rate of catheter dysfunction in hemodialysis
      patients with a history of TCC dysfunction requiring urokinase therapy.
    


Intervention name(s): Taurolidine Urokinase; Taurolidine Heparin
Intervention type(s): Drug; Drug
Other intervention name(s): Taurolock Urokinase 25,000; Taurolock HEP 500
Intervention MeSH terms: Taurolidine; Heparin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Prevention, Thrombosis, Hemodialysis, Vascular access device
Evaluating the Safety and Immunogenicity of a Live Attenuated West Nile Virus Vaccine for West Nile Encephalitis in Adults 50 to 65 Years of Age
Condition: West Nile Virus
MeSH terms: Encephalitis
Study type: Interventional
Phase: Phase 1

Summary: 
      West Nile virus (WNV) is considered an emerging virus in the United States, and infection can
      lead to severe illness in older adults. This study will evaluate the safety of and immune
      response to a live West Nile virus vaccine (WN/DEN4Δ30) for the prevention of West Nile
      encephalitis in adults 50 to 65 years old.
    

Detailed description: 
      WNV is the leading vector-borne cause of viral encephalitis in the United States. Severe
      illness is most common in older adults, and in this population, the virus can cause
      hepatitis, meningitis, and encephalitis leading to paralysis, coma, and death. WNV illness is
      a public health issue and is an emerging disease in the United States. This study will
      evaluate the safety and immunogenicity of a live attenuated West Nile/dengue chimeric virus
      vaccine (WN/DEN4Δ30) for the prevention of West Nile encephalitis in adults 50 to 65 years
      old.

      This study will enroll healthy adults, 50 to 65 years old, who have no history of previous
      flavivirus infection. Participants will be randomly assigned to receive the WN/DEN4Δ30
      vaccine or placebo vaccine at study entry (Day 0). At the entry visit, participants will
      undergo a medical history review, physical examination, blood collection, and vital sign
      measurements; female participants will also take a pregnancy test. Participants will then
      receive their assigned vaccine, and they will remain in the clinic for 30 minutes after the
      vaccination for monitoring. Participants will record their temperature and symptoms 3 times a
      day for 16 days after each vaccination. Additional study visits will occur on Days 3, 6, 8,
      10, 12, 14, 16, 21, 28, 56, 90, and 150. These visits may include the same study procedures
      that occurred at the entry visit. At a study visit on Day 180, participants will receive
      another dose of their assigned vaccine. Additional study visits will occur on Days 183, 186,
      188, 190, 192, 194, 196, 201, 208, 236, 270, and 360. All study procedures after the second
      vaccination will be the same that occurred after the first vaccination.
    

Intervention name(s): WN/DEN4Δ30 Vaccine; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): WN/DEN4Δ30 vaccine is a live attenuated, recombinant, chimeric virus. Dose: 10^4 plaque-forming units (PFUs); delivered by subcutaneous injection in the deltoid region of the upper arm.; Delivered by subcutaneous injection in the deltoid region of the upper arm.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: West Nile Virus, vaccine
Mirror Therapy and Hand Rehabilitation
Condition: Hand Fractures
Study type: Interventional

Summary: 
      Objective: The purpose of this study is to determine effects of mirror therapy in restoring
      hand function in patients with flexor lag following orthopedic injuries.

      Methods: In a prospective randomized controlled trial, 22 patients with Flexor Lag will be
      measured. Intervention group will receive mirror therapy, 30-minute a day, 5 days a week for
      3-week, as well, half an hour conventional rehabilitation after each mirror therapy session.
      Patients in the control group will receive the same treatment program, but instead of mirror,
      they will directly observe the affected hand. Outcome measures including Total Active Motion
      (TAM), and Disabilities of Arm, Shoulder and Hand (DASH) questionnaire will be administered
      before and after the treatment period and 3 weeks after the final treatment session.
    


Intervention name(s): Mirror therapy; Classical rehabilitation techniques
Intervention type(s): Other; Other
Intervention description(s): mirror therapy; splinting, tendon gliding, active range of motion, activities of daliy living
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hand Flexor tendon Injuries; hand Extensor Tendon Injuries; Hand Joint Dislocations and subluxation
14473 - D9126C00001 Proof of Principle Study - Effect of AZD2066 on Transient Lower Esophageal Sphincter Relaxations
Condition: Reflux Episodes
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of the study is to assess the safety and tolerability of AZD2066 and to explore
      the effect of a single dose of AZD2066 on the function of the cardia (the opening between the
      stomach and the esophagus) compared to placebo (not containing any medical substance) in
      healthy volunteers.
    


Intervention name(s): AZD2066; Placebo; AZD2066; AZD2066; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 13 mg oral solution, 1 single dose; Oral solution, 1 single dose; Dose to be decided after Part A, including dose A (active) and B (placebo). Oral solution, 1 single dose; Dose to be decided after Part A, including dose A (active) and B (placebo). Oral solution, 1 single dose; Oral solution, 1 single dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: GERD; TLESR; reflux
Study of Bathing With Chlorhexidine Impregnated Cloths on Nosocomial Infections in the Pediatric Intensive Care Unit
Condition: Nosocomial Infections
MeSH terms: Infections; Communicable Diseases; Cross Infection
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The investigators propose to conduct a large clinical study to determine if daily bathing
      with chlorhexidine impregnated cloths will reduce the incidence of healthcare-associated
      infections in the Pediatric Intensive Care Unit (PICU).
    


Intervention name(s): 2% Chlorhexidine gluconate cloth
Intervention type(s): Drug
Intervention description(s): Daily bathing
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: intensive care unit; Healthcare associated infections (HAI); pediatric