bioihbjkbjnl/mcl2 huggingface dataset:
Prevention of Esophageal Varices by Beta-Adrenergic Blockers
Condition: Esophageal and Gastric Varices; Liver Cirrhosis; Portal Hypertension
MeSH terms: Liver Cirrhosis; Hypertension, Portal; Esophageal and Gastric Varices; Hypertension; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to learn whether timolol is useful in preventing or delaying the
      appearance of gastroesophageal varices, a complication that may develop in the future as a
      consequence of liver disease. Cirrhosis causes an increased resistance of blood flowing
      through the liver. This leads to an increased pressure in the portal vein (the vein that
      takes blood to your liver). High portal pressure is responsible for the appearance of
      complications of chronic liver disease such as varices and variceal bleeding (bleeding from
      veins in your esophagus). Timolol belongs to a group of medications called beta-blockers.
      Beta-blockers decrease high portal pressure and previous studies have shown that beta-blocker
      pills are useful in preventing bleeding from varices in patients who already have varices. A
      more desirable effect would be if these pills could prevent not only bleeding from varices
      but the appearance of varices (and therefore of bleeding).
    


Intervention name(s): Timolol Maleate; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Timolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: cirrhosis; esophageal varices; variceal hemorrhage; beta-adrenergic blocker
Premedication With Alprazolam and Midazolam for Upper Gastrointestinal Endoscopy
Condition: Diagnostic Esophagogastroduodenoscopy
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Diagnostic upper GI endoscopy can be uncomfortable and stressful for many patients. Various
      methods are available for sedation during this procedure. Because of some side effects
      related to intravenous administration of sedatives, oral administration of these drugs is
      under attention. Alprazolam is a benzodiazepine which is used mainly in treatment of anxiety.
      Intravenous midazolam is being used by some centers for sedation during endoscopy, but the
      oral form can also be used with probably same efficacy. Hence, investigators compare the
      efficacy/safety of oral midazolam and sublingual alprazolam as for sedation during this
      procedure. Investigators hypothesize that sublingual alprazolam is as effective as oral
      midazolam in reducing anxiety and pain/discomfort related to the procedure.
    


Intervention name(s): Sublingual alprazolam; Oral midazolam
Intervention type(s): Drug; Drug
Intervention description(s): Patients receive one dose of oral formulation of alprazolam 0.5 mg for sublingual-administered at least 30 minutes before the procedure.; Patients receive one dose of intravenous formulation of alprazolam 7.5 mg for oral-administered (in syrup with apple juice) at least 30 minutes before the procedure.
Intervention MeSH terms: Midazolam; Alprazolam
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A HR20031 BE Study on Healthy Subjects
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the bioequivalence between HR20031 FDC tablet and
      co-administration of SHR3824 tablets, SP2086 tablets and metformin XR tablets.
    


Intervention name(s): ARM A; ARM B; ARM C; ARM D; ARM E; ARM F
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Subjects will receive treatment SHR3824 10 mg+ SP2086 100 mg+ Metformin 500 mg XR*2 followed by 7 days washout ，then receive treatment SHR3824 10 mg+ SP2086 100 mg+ Metformin 500 mg XR*2 followed by 7 days washout and then receive treatment HR20031 FDC 10/100/1000 mg.; Subjects will receive treatment HR20031 FDC 10/100/1000 mg followed by 7 days washout ，then receive treatment SHR3824 10 mg+ SP2086 100 mg+ Metformin 500 mg XR*2 followed by 7 days washout and then receive treatment SHR3824 10 mg+ SP2086 100 mg+ Metformin 500 mg XR*2.; Subjects will receive treatment SHR3824 10 mg+ SP2086 100 mg+ Metformin 500 mg XR*2 followed by 7 days washout ，then receive treatment HR20031 FDC 10/100/1000 mg followed by 7 days washout and then receive treatment SHR3824 10 mg+ SP2086 100 mg+ Metformin 500 mg XR*2.; Subjects will receive treatment SHR3824 5 mg*2+ SP2086 50 mg*2+ Metformin 500 mg XR*3 followed by 7 days washout ，then receive treatment SHR3824 5 mg*2+ SP2086 50 mg*2+ Metformin 500 mg XR*3 followed by 7 days washout and then receive treatment HR20031 FDC 5/50/750 mg*2.; Subjects will receive treatment HR20031 FDC 5/50/750 mg*2 followed by 7 days washout ，then receive treatment SHR3824 5 mg*2+ SP2086 50 mg*2+ Metformin 500 mg XR*3 followed by 7 days washout and then receive treatment SHR3824 5 mg*2+ SP2086 50 mg*2+ Metformin 500 mg XR*3.; Subjects will receive treatment SHR3824 5 mg*2+ SP2086 50 mg*2+ Metformin 500 mg XR*3 followed by 7 days washout ，then receive treatment HR20031 FDC 5/50/750 mg*2 followed by 7 days washout and then receive treatment SHR3824 5 mg*2+ SP2086 50 mg*2+ Metformin 500 mg XR*3.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: There will be two independent cohorts of subjects who will each receive two treatments (high dose strength and low dose strength), and each treatment will be followed by 72 hours of blood sampling for pharmacokinetic assessments, with safety and tolerability. In each cohort approximately 42 healthy subjects will be randomized to receive treatment with IP to complete at least 36 evaluable subjects.
Masking: None (Open Label)
Primary purpose: Treatment
A Research Study to Assess the Mechanism By Which Glucovance, Metformin, and Glyburide Work To Control Glucose Levels In Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Non-Insulin-Dependent
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this clinical research study is to support earlier observations that
      Glucovance controls glucose levels after a mean, and improves overall glucose control better
      than metformin or glyburide therapy alone in adults with type 2 diabetes.
    


Intervention name(s): Glucovance (metformin HCl/glyburide); or Metformin HCl alone; or Glyburide alone.
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Metformin; Glyburide
Primary purpose: Treatment
Keywords: Type 2 Diabetes Mellitus
Effect of Propofol on Cardioprotective Role of Remote Ischemic Preconditioning (RIPC)
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      This study involves research using human subjects (cardiac surgical patients) to evaluate the
      effect of remote ischemic preconditioning (RIPC) on cardioprotective outcomes. RIPC applied
      to upper or lower extremities has been shown cardioprotective role by lowering release of
      cardiac troponin in patients with cardiac diseases. However, it is not clear whether
      anesthetics, such as propofol or sevoflurane, may impair the cardioprotective effect of RIPC
      in cardiac surgical patients. Therefore, the purpose of the study is to compare the effects
      of anesthetics on cardioprotection of RIPC in patients undergoing cardiac surgery.
    

Detailed description: 
      Patients undergoing cardiac surgery using cardiopulmonary bypass will be randomized to
      control, propofol, or sevoflurane group. Patients in the control group will receive remote
      ischemic preconditioning (RIPC) on their upper arms before anesthetic induction. Patients in
      the propofol or sevoflurane groups will receive RIPC after anesthetic induction using
      propofol or sevoflurane, respectively. In all patients, arterial blood samples will be
      obtained before and after each RIPC. From the samples, human dialysate will be obtained and
      perfused to rat heart through Langendorff apparatus before ischemia-reperfusion injury to the
      rat heart. Infarct size of the sectioned rat heart will be compared among the three -
      control, propofol, and sevoflurane - groups.
    

Intervention name(s): Control; Propofol; Sevoflurane
Intervention type(s): Other; Drug; Drug
Intervention description(s): Patients in the control groups do not receive any anesthetic during remote ischemic preconditioning.; Patients in the propofol group receive propofol anesthesia during remote ischemic preconditioning.; Patients in the sevoflurane group receive sevoflurane anesthesia during remote ischemic preconditioning.
Other intervention name(s): Not receiving any anesthetic; Receiving propofol anesthesia; Receiving sevoflurane anesthesia
Intervention MeSH terms: Anesthetics; Propofol; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Propofol; Sevoflurane; Preconditioning
New Dosages of Inflammatory Markers for the Early Diagnosis of Nosocomial Bacterial Infections of the Newborn
Condition: Nosocomial Infection
MeSH terms: Infections; Communicable Diseases; Bacterial Infections; Cross Infection
Study type: Observational

Summary: 
      This study aims to evaluate new dosage of inflammatory markers or new inflammatory markers
      for the diagnosis of nosocomial bacterial infection. We made the hypothesis that these new
      dosages or new inflammatory markers could be more useful than dosage of inflammatory markers
      already used in clinical practice (especially the use of a combination of interleukins (6 or
      8) and C-reactive protein for the management of newborns with a clinical suspicion of
      nosocomial bacterial infection and especially could allow to avoid excessive treatment with
      antibiotics
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Newborn hospitalized in neonatal intensive care unit with a clinical suspicion of
        nosocomial bacterial infection
      
Biospecimen description: 
      Serum
    
Keywords: Late onset neonatal sepsis; Nosocomial bacterial infection; Inflammatory markers; multiplex dosage
No-commercial Enteral Diet for Patients in Home Nutritional Therapy: Effects on Anthropometric and Biochemical Indices
Condition: Malnutrition
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      The objective is to evaluate the effect of no-commercial enteral diet for patients in home
      nutritional therapy in anthropometric and biochemical indices comparing to patients using
      commercial enteral diets.
    


Intervention name(s): Dietary therapy
Intervention type(s): Dietary Supplement
Intervention description(s): A enteral diet formulation was developed to meet dietary requirements of adult patients. The formulation was standarized in household measures so that caregivers would prepare it and delivered it at the patients' home. Anthropometric measurements and blood samples were taken at baseline and at the end of the intervention which lasted four months.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Automatic Real-time Diagnosis of Gastric Mucosal Disease Using pCLE With Artificial Intelligence
Condition: Gastric Diseases; Artificial Intelligence; Confocal Laser Endomicroscopy
MeSH terms: Stomach Diseases
Study type: Observational

Summary: 
      Probe-based confocal laser endomicroscopy (pCLE) is an endoscopic technique that enables
      real-time histological evaluation of gastric mucosal disease during ongoing endoscopy
      examination. However this requires much experience, which limits the application of pCLE. The
      investigators designed a computer-aided diagnosis program using deep neural network to make
      diagnosis automatically in pCLE examination and contrast its performance with endoscopists.
    


Intervention name(s): The diagnosis of Artificial Intelligence and endoscopist
Intervention type(s): Diagnostic Test
Intervention description(s): When suspected lesion is observed using pCLE, endoscopist and AI will make a diagnosis independently. In addition, the endoscopist can not see the diagnosis of AI.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Consecutive patients who receive the upper gastrointestinal tract pCLE examination and
        screened that fulfill the eligibility criteria at Qilu Hospital, Shandong University will
        be enrolled into the study
      
Biospecimen description: 
      When a gastric mucosal lesion is found using white light endoscopy , endoscopist will observe
      this lesion using pCLE and then take biopsy for histology examination.
Effect of Caloric Restriction on Fat Oxidation in Obese Men and Women (Magellan II)
Condition: Obesity; Overweight; Metabolic Diseases
MeSH terms: Overweight; Metabolic Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to better understand the different ways our bodies burn fat
      which may be important for obesity, diabetes, and cardiovascular disease.
    

Detailed description: 
      In this study the investigators will examine the hypothesis that overweight/obese individuals
      that are unable to meet target weight loss goals on a low calorie diet (LCD) are
      intrinsically less metabolically flexible than their weight-losing counterparts. The
      investigators expect that this 'inflexibility' will be characterized by impaired fat
      oxidation (as determined by indirect calorimetry) in response to caloric restriction. If this
      were the case, these subjects may represent a population of 'super-responders' likely to
      demonstrate a robust response to approaches to increase fat oxidation. The investigators will
      also measure lipid concentrations in skeletal muscle and liver by hydrogen 1 magnetic
      resonance (1H-MRS) to determine both the stability of these measurements as well as the
      magnitude of changes that can be seen during LCD.
    

Intervention name(s): Low Calorie Diet (LCD); Phentermine
Intervention type(s): Behavioral; Drug
Intervention description(s): A Diet History Questionnaire was completed and subjects had dietary counseling and were provided shakes. The low calorie diet began, to continued for a period of 8 weeks.; Individuals not on track to achieve their target weight by four weeks received the drug Phentermine to promote weight loss. Then, following eight weeks LCD (or four weeks LCD + four weeks LCD+Phentermine), in the event that they did not achieve the target weight loss, subjects were given the option to continue with the LCD + Phentermine for up to an additional 12 weeks, under a doctor's supervision.
Protection Against Risk:
Prior to administering any phentermine, a history and physical including EKG will be conducted (at the screening visit) and will be used to determine whether the participant is clear to receive the medication.
Participants will see the study doctor or nurse practitioner at every study visit after the drug is initiated.
Intervention MeSH terms: Phentermine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: fatty acid oxidation; Proton magnetic resonance spectroscopy
The Communication of Genetic Risk to Adolescent Daughters of Women With Breast Cancer
Condition: Breast Cancer; Counseling
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      The purpose of this study is to first understand how MSKCC Clinical Genetics Service doctors
      talk to women with breast cancer about any genetic risks they might carry, and if they help
      women to think about what they might say, in turn, to their relatives, especially their
      daughters.

      A second part of the study asks women for their opinions about when and how their daughters
      should be told about any genetic risks.

      All of this will help us develop teaching methods to help our doctors improve the way they
      talk about genetic risk when women with breast cancer have adolescent daughters.
    


Intervention name(s): focus group & questionaire
Intervention type(s): Behavioral
Intervention description(s): The focus group will last about 90 minutes. However, your involvement in this study will last from the time you join until you read over the summary of what happened during the focus group and return your comments. This should be approximately 2 months. Patient will complete a questionnaire and we estimate total time for completion to be approximately 7 minutes.
Observational model: Family-Based
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Memorial Sloan-Kettering Cancer Center (MSK) breast cancer patients seen by the clinical
        genetics service (CGS)and their daughters
      
Keywords: Daughters; Communication; genetic risk; Genetic Counseling
Tofacitnib for the Treatment of Alopecia Areata and Variants
Condition: Alopecia Areata (AA); Alopecia Totalis (AT); Alopecia Universalis (AU)
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the ability of tofacitinib citrate, a Janus
      kinase inhibitor, to generate hair regrowth in patients with moderate to severe alopecia
      areata and its variants.
    

Detailed description: 
      This study is an open-label pilot study. Participants will be treated with oral tofacitinib
      for a maximum of 5 months. Participants will be evaluated at 3 months after completion of
      therapy to evaluate for durability of response, late response and/or late adverse effects.
    

Intervention name(s): Tofacitinib Administration
Intervention type(s): Drug
Intervention description(s): 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.
Intervention MeSH terms: Tofacitinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Assess the Relative Bioavailability of a Modified-Release Formulation of PF-05180999
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the bioavailability, safety, and tolerability of a
      modified-release formulation of PF-05180999 relative to an immediate-release formulation in
      healthy adult subjects. Two doses of the modified-release formulation and one dose of the
      immediate-release formulation will be evaluated under fasted conditions. One dose of the
      modified-release formulation will also be evaluated in the presence of food.
    


Intervention name(s): PF-05180999; PF-05180999; PF-05180999; PF-05180999
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single dose of 30 mg of PF-05180999 administered to fasted subjects as an immediate-release powder-in-capsule formulation; Single dose of 30 mg of PF-05180999 administered to fasted subjects as a modified-release formulation; Single dose of 120 mg of PF-05180999 administered to fasted subjects as a modified-release formulation; Single dose of 30 mg of PF-05180999 administered to fed subjects as a modified-release formulation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: PF-05180999; safety; pharmacokinetics; relative bioavailability; Mental Disorders; Schizophrenia and Disorders with Psychotic Features; Schizophrenia
Physiologic Investigation of the Renin Angiotensin Aldosterone Axis in HIV
Condition: HIV-infection
MeSH terms: HIV Infections
Study type: Observational

Summary: 
      The purpose of this study is to see if individuals with HIV-infection, particularly those
      with increased belly fat, have abnormalities in the renin angiotensin aldosterone axis.
      Renin, angiotensin, and aldosterone are hormones that regulate salt and water balance in the
      body, and they may also have effects on sugar metabolism and cardiovascular health. There is
      some evidence that individuals with HIV-associated abdominal fat accumulation may have
      increased aldosterone, which may contribute to abnormalities in sugar metabolism and
      increased cardiovascular disease seen in HIV. The purpose of this study is the measure renin,
      angiotensin, and aldosterone activity, as well as other hormonal axes, in people with and
      without HIV infection, and with and without increased belly fat. The investigators
      hypothesize that aldosterone will be increased in HIV-infected individuals compared to those
      without HIV-infection, and that aldosterone will be further increased in HIV-infected
      individuals with increased abdominal fat compared to those without abdominal fat
      accumulation.
    


Intervention name(s): Angiotensin II Infusion
Intervention type(s): Drug
Intervention description(s): Angiotensin II (Bachem) will be infused at 0.3 ng/kg/min for 30 minutes, then 1.0 ng/kg/min for 30 minutes, then 3.0 ng/kg/min for 30 minutes; at baseline and at each infusion concentration, serum aldosterone will be measured. BP and heart rate will be monitored at baseline and every 2 minutes during the infusion.
Intervention MeSH terms: Angiotensin II; Giapreza; Angiotensinogen
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        50 HIV-infected and 50 non-HIV-infected male and female volunteers, ages 18-65 years old.
      
Keywords: HIV-infection; renin; aldosterone; visceral fat
A Multi-Center Investigation of Patient Acceptability of OPTI-FREE RepleniSH® Multi-Purpose Disinfecting Solution (MPDS)
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The purpose of this study was to demonstrate that current successful fulltime daily wear soft
      contact lens wearers using competitive multi-purpose solutions will note improved comfort
      when using OPTI-FREE RepleniSH®.
    


Intervention name(s): Multi-Purpose Disinfecting Solution (OPTI-FREE RepleniSH); Contact Lenses
Intervention type(s): Device; Device
Intervention description(s): OPTI-FREE RepleniSH® used according to product labeled instructions for cleaning and disinfecting study contact lenses, 30 days.; Contact lenses per participant's habitual prescription removed nightly for cleaning and disinfecting.
Other intervention name(s): OPTI-FREE RepleniSH®
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: contact lens solution; OPTI-FREE RepleniSH; contact lenses