bioihbjkbjnl/mcl2 huggingface dataset:
Role of Esophageal Mast Cell Activation in Noncardiac Chest Pain (NCCP)
Condition: Noncardiac Chest Pain (NCCP)
MeSH terms: Chest Pain
Study type: Observational

Summary: 
      Chest pain is a common clinical complaint. About 30% patients with chest pain will have a
      normal coronary angiogram and are described as having noncardiac chest pain (NCCP). It is
      estimated that 25% of the population complain of chest pain at some time in their lifetime.
      The pathogenesis of NCCP is unknown. Esophageal hypersensitivity as a result of inflammation
      is considered to be an important mechanism in the development of this pain sensation. Little
      is currently known about the interaction between inflammatory mediators and peripheral
      afferent nerve terminals in the esophagus. The mast cell is one of the most enriched
      pro-inflammatory cells in the gastrointestinal tract. Activation of the mucosal mast cell
      releases a variety of mediators into adjacent tissues. We hypothesize that mediators released
      by mast cells sensitize esophageal nociceptors and induce pain sensation.
    

Detailed description: 
      1. Key Objectives: To determine the density and activation of esophageal mast cells in
           non-cardiac chest pain patients. We expect to find mast cell activation, as measured by
           mast cell count or degranluation, tryptase staining, and histamine release, will be
           greater in NCCP patients compared to controls, and the increased mast cell activation
           will correlate with the severity of NCCP. These results will expand our understanding of
           the pathogenesis of esophageal originated NCCP, and allow the development of new
           diagnostic and treatment options.

        2. Study Population: (i) NCCP (ii) Reflux esophagitis (iii) Control subjects.

        3. Summary of Procedures: (i) symptom assessment by chest pain questionnaire; (ii)
           esophageal reflux evaluation by review of records of 24-hour pH monitoring; (iii)
           evidence of esophagitis by endoscopy; (iv) esophageal biopsy by endoscopy; (v) mast cell
           activation study in biopsy specimen by mast cell count, tryptase and Transient receptor
           potential vanniloid-1 (TRPV1) staining, and histamine release assay.

        4. Major Risks & Discomforts: There are no major risks & discomforts other than involved in
           standard upper GI endoscopy.
    

Time perspective: Prospective
Keywords: NCCP, mast cell, esophagus
Ezetimibe/Simvastatin (10 mg/40 mg) vs. the Doubling of Atorvastatin in High Risk Participants (MK-0653A-134 AM1)(COMPLETED)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      Participants currently taking atorvastatin 20 mg will be switched to either atorvastatin 40
      mg or ezetimibe/simvastatin 10 mg/40 mg (10/40). After 6 weeks of treatment, the percent
      reduction in low-density lipoprotein cholesterol (LDL-C) will be assessed and compared
      between the two treatment groups.
    


Intervention name(s): ezetimibe/simvastatin 10/40; atorvastatin 40 mg; atorvastatin 20 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): ezetimibe/simvastatin 10/40 tablet once daily for 6 weeks.; atorvastatin 40 mg tablet once daily for 6 weeks; All participants will take atorvastatin 20 mg tablet once daily for the 5 week run-in period before randomization
Other intervention name(s): Vytorin; Lipitor; Lipitor
Intervention MeSH terms: Atorvastatin; Simvastatin; Ezetimibe; Ezetimibe, Simvastatin Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Gan & Lee Insulin Glargine Target Type (1) Evaluating Research
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Objective:

      •To evaluate equivalence of Gan & Lee Insulin Glargine Injection and Lantus® in terms of
      immunogenicity

      Secondary Objective:

      Immunogenicity:

      • To evaluate the percentage of subjects with negative anti-insulin antibodies (AIAs) at
      baseline who develop confirmed positive AIA up to Week 26, the percentage of baseline in AIA
      titers between treatment groups, the percentage of subjects with confirmed positive AIA who
      develop any anti-insulin neutralizing antibodies up to visit Week 26, and percentage of
      subjects who develop confirmed positive AIA up to visit Week 26 of Gan & Lee Insulin Glargine
      Injection in comparison with that of Lantus®.

      Safety:

      •To evaluate the safety of Gan & Lee Insulin Glargine Injection in comparison with that of
      Lantus®.

      Efficacy:

      •To evaluate the efficacy of Gan & Lee Insulin Glargine Injection in comparison with that of
      Lantus®.
    


Intervention name(s): Gan & Lee Insulin Glargine Injection; Lantus®
Intervention type(s): Biological; Biological
Intervention description(s): Route of administration: subcutaneous injection; Route of administration: subcutaneous injection
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects who meet the study eligibility criteria will be centrally randomized 1:1 in an open-label fashion to receive either Gan & Lee Insulin Glargine Injection or Lantus® for 26 weeks. Randomization will be stratified by country.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; Diabetes Type 1; Type 1; Basal; Insulin; Glargine; T1DM; Diabetes Mellitus; Insulin Dependent Diabetes
SCH-58500 in Treating Patients With Primary Ovarian, Fallopian Tube, or Peritoneal Cancer (C95084)
Condition: Fallopian Tube Cancer; Metastatic Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer
MeSH terms: Fallopian Tube Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Giving the p53 gene for ovarian, fallopian tube, or peritoneal cancer may inhibit
      tumor growth. Giving the gene directly into the peritoneum may kill more cancer cells.

      PURPOSE: Phase I trial to study the effectiveness of SCH-58500 in treating patients who have
      recurrent or persistent primary ovarian, fallopian tube, or peritoneal cancer.
    

Detailed description: 
      OBJECTIVES: I. Assess the safety of SCH-58500 (recombinant adenoviral vector containing p53
      tumor suppressor gene) when given as a single or multiple intraperitoneal instillation in
      combination with chemotherapy to patients with peritoneal carcinomatosis demonstrating p53
      mutant ovarian, fallopian tube, or peritoneal carcinoma. II. Assess the biological activity
      of SCH-58500 by confirming wild type p53 gene expression. III. Assess the stability of
      SCH-58500 infection and expression by collection and analysis of serial, posttreatment,
      ascites specimens in a subset of 5 patients. IV. Assess the pharmacokinetics of SCH-58500 by
      serum and peritoneal fluid measurements. V. Document any clinical evidence of antitumor
      activity in these patients treated with this regimen.

      OUTLINE: This is an abbreviated dose escalation, multicenter study of SCH-58500. Patients
      receive SCH-58500 by intraperitoneal instillation on days 1-5 (depending on dose level).
      Patients undergo ascites fluid and tumor sampling before and after intraperitoneal
      instillation. The ascitic fluid or tumor and normal tissue are then submitted for cytologic
      or histopathologic examination and biological activity analysis. Cohorts of 3-6 patients
      receive escalating doses of SCH-58500 until 3 patients experience dose limiting toxicity or
      until the highest planned dose is reached. Patients are followed at 2 months, every 3 months
      for 1 year, and then yearly thereafter.

      PROJECTED ACCRUAL: A total of 6-60 patients will be accrued for this study.
    

Intervention name(s): recombinant adenovirus-p53 SCH-58500
Intervention type(s): Biological
Primary purpose: Treatment
Keywords: recurrent ovarian epithelial cancer; malignant ascites; fallopian tube cancer; primary peritoneal cavity cancer
Oxaliplatin in Unresectable Hepatocellular Carcinoma
Condition: Carcinoma, Hepatocellular
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary:

        -  To determine the Tumor Response Rate of patients with hepatocellular carcinoma treated
           with the combination chemotherapy of Eloxatin+5-Fluorouracil/Leucovorin

      Secondary:

        -  Safety and tolerability of this regimen in these patients
    


Intervention name(s): Oxaliplatin
Intervention type(s): Drug
Intervention MeSH terms: Oxaliplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Glycaemic Responses to Cracker Snacks
Condition: Glycaemic Response Measurements
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether added ingredient affects glycaemic
      responses to a cracker snack.
    


Intervention name(s): Control Cracker Snack; Experimental Cracker Snack 1; Experimental Cracker Snack 2
Intervention type(s): Other; Other; Other
Intervention description(s): Base cracker snack; Cracker snack containing test ingredient 1; Cracker snack containing test ingredient 2
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Glycaemic Response
The Study of a Selective Serotonin Partial Agonist and Reuptake Inhibitors, HEC113995PA•H2O,in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a safety, tolerability, and pharmacokinetics phase Ⅰstudy of a selective
      Serotonin partial agonist and reuptake inhibitors, HEC113995PA•H2O,in healthy subjects.This
      study is the healthy adult subjects single ascending-dose research.
    

Detailed description: 
      There have set up seven dose group(2.5、5、10、20、40、60、80mg）.The first group(2.5mg)contains 8
      health subjects(6 health subjects take experimental drugs,2 health subjects take the
      placebo). Other groups contains 10 health subjects(8 health subjects take experimental
      drugs,2 health subjects take the placebo).Within 30min before taking the medicine and after
      0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 24h, 36h, 48h,72h to take blood samples
      for pharmacokinetics(PK) detection.
    

Intervention name(s): HEC113995PA•H2O tablet; Placebo tablet
Intervention type(s): Drug; Drug
Intervention description(s): 2.5-、5-、10-、20-、40-、60-、80mg HEC113995PA•H2O tablet in day1.; 2.5-、5-、10-、20-、40-、60-、80mg Placebo tablet in day1.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Stress Management for Couples Undergoing In Vitro Fertilization (IVF)
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators are trying to determine stress management strategies in couples undergoing
      In Vitro Fertilization (IVF).
    

Detailed description: 
      The investigators are trying to determine two different stress management techniques in
      couples undergoing IVF. One arm will be randomized to learning these techniques by themselves
      by watching and following instructions on a digital video disc (DVD). The other arm will have
      an in-person class that will teach the couples different stress reduction techniques.
    

Intervention name(s): Stress Management & Resiliency Training; Stress Management DVD
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The couples in this group will attend the SMART in-person training class at the beginning of the study and will be taught a structured relaxation program.; The couples in this group will receive a Mayo Clinic Stress Management DVD.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Infertility; In Vitro Fertilization (IVF); Stress Management; Stress Reduction
A Clinical Study of Xenetix 300 in Multislice Computed Tomography (CT) Pediatric Indications
Condition: Diagnostic Imaging
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a clinical study of Xenetix 300 in Multislice Computed Tomography (MSCT) in pediatric
      indications.
    


Intervention name(s): Xenetix; Visipaque
Intervention type(s): Drug; Drug
Intervention description(s): 300 mg of iodine/ml; 270 mg of iodine/ml
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Multislice computed tomography (MSCT)indications
The Empowerment Model Towards Type 2 Diabetic Adults To Enhance Vegetable Intake in Achieving Glycemic Control
Condition: Glycemic Control for Diabetes Mellitus
Study type: Interventional
Phase: Phase 2

Summary: 
      Life style changes, particularly in dietary patterns have contributed a great deal to the
      incidence and risks of type 2 Diabetes. Decreased intakes of vegetables and fruits replaced
      by pre processed food, added sugar and those of animal origin lead towards rapid increase of
      adult-onset-diabetes.

      In spite of the knowledge of the benefit of consuming vegetable and fruits, and people are
      well informed, they still need to be committed to perform a behavior and implement these
      intention. Behavioral approach methods have demonstrated successful adherence in health
      education with life style changes.

      Objective: To identify the impact of The Empowerment Model to enhance vegetable intake in
      Type 2 Diabetes Mellitus adults in achieving glycemic control.
    


Intervention name(s): Empowerment model to improve dietary intake; Control group following conventional approach
Intervention type(s): Behavioral; Other
Intervention description(s): Empowerment model using specific guidelines to improve dietary intake; Control group following conventional approach
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: HbA1C
Pain Neuroscience Education in Patients With Total Knee Arthroplasty
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The aim of Pain Neuroscience Education (PNE) is to explain to patients the biological and
      physiological processes involved in a pain experience and, more importantly, defocus the
      issues associated with the anatomical structures. PNE provides compelling evidence in
      reducing pain, disability, pain catastrophization, and limited physical movement in
      musculoskeletal problems. Knee osteoarthritis (KOA) is a very common painful musculoskeletal
      problem, especially in people over 50 years old, and lead to decrease in knee range of
      motion. Despite costly arthroscopic surgeries and long-term physiotherapy treatments, poor
      outcomes are common. The lack of satisfactory results suggests that some practices should be
      revised. Although PNE could be useful as an intervention, to our knowledge, there is no
      randomized controlled trial in the literature investigating the effects of PNE in patients
      with a KOA. Therefore, we aimed to examine the effectiveness of PNE on clinical outcomes in
      patients with KOA.
    


Intervention name(s): Pain Neuroscience Education; Standard Physiotherapy Program (SPP)
Intervention type(s): Other; Other
Intervention description(s): The experimental group will follow a PNE protocol based on previous procedure for 6 weeks in addition to the standard physiotherapy program (SPP) in postoperative period.
Each PNE session will take 45-60 min. PNE will be conducted in line with international guidelines and covered the neurophysiology of pain, transition from acute to chronic pain, and the nervous system ability to modulate the pain experience.; The control group will follow a SPP. The 45-minute-long treatment sessions will be held 5 days per week. The treatment program will be organized in 3 periods as 0-2 weeks, 3-4 weeks and 5-6 weeks. The overall treatment program will include scar massage, patellar mobilization, coldpack, ankle pump, quadriceps and hamstring strengthening, hip range of motion, hip strengthening exercises, squat, ascending and descending stairs, walking training. All exercises will be 10 repetitions x 2 sets.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: pain neuroscience education; knee; osteoarthritis
Comparison of Azelaic Acid 20 % Cream Versus Hydroquinone 4% Cream as an Adjuvant to Oral Tranexamic Acid in Melasma
Condition: Melasma
MeSH terms: Melanosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Methodology: Fifty female patients presented with melasma (symmetrically distributed
      hyperpigmented macules and patches on the face) diagnosed by consultant dermatologist on
      clinical presentation were included in this study. The sample size was calculated by WHO
      Sample Size calculator taking 31% proportion of excellent response with 4% hydroquinone as an
      adjuvant to oral tranexamic acid as compared to 2.25% proportion of excellent response with
      20% azelaic acid, 80% power of test and 5% significance level. After randomization, patients
      were divided into two groups. Group A was managed with 4% hydroquinone cream as an adjuvant
      to oral tranexamic acid (250 mg twice daily) while group B was managed with topical 20%
      azelaic acid (daily at night) for six months. Clinical evaluation was done initially at the
      start of therapy and then at 2nd, 4th and 6th month using MASI score and patient's response.
      Efficacy was assessed in both groups at the end of therapy after six months.
    


Intervention name(s): Group A 4 % Hydroquinone Cream Topically and Oral Tranexamic Acid; Group B Azelaic Acid 20 % Cream for 6 months
Intervention type(s): Drug; Drug
Intervention description(s): Group A was managed with 4% hydroquinone cream as an adjuvant to oral tranexamic acid (250 mg twice daily) for 6 months; Group B was managed with topical 20% azelaic acid (daily at night) for six months.
Intervention MeSH terms: Azelaic acid; Tranexamic Acid; Hydroquinone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Changes in Breast 3D Ultrasound Measurements Using Toremifene
Condition: Circulatory; Change
Study type: Interventional
Phase: Phase 3

Summary: 
      To investigate if there are detectable changes in volume and circulation in breasts of
      healthy volunteers using toremifene 20 mg in luteal phase of the menstruation cycle versus
      nonmedicated cycle.
    

Detailed description: 
      20 women were participated to this trial.
    

Intervention name(s): Toremifene
Intervention type(s): Drug
Intervention description(s): 20mg toremifene per day in tablet form starting from the cycle day 15 and continued to premenstrual period. Medication using about 10 days per volunteer
Other intervention name(s): trade name Fareston
Intervention MeSH terms: Toremifene
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: toremifene
Diabetes Prevention Programming for Women With a History of Gestational Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes, Gestational; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to offer women with a history of gestational diabetes access to
      diabetes prevention programming; their children 10 and older can participate.
    

Detailed description: 
      The purpose of this study is to offer women with a history of gestational diabetes access to
      diabetes prevention programming; their children 10 and older can participate. There are two
      potential types of participants:

        1. Women and their children 10+ can consent to participate in the diabetes prevention
           programming offered through Dr. Hannon's center (called Encourage). Researchers will
           collect data at three time points, baseline, 4-6 months, and 12 months.

        2. Instead of participating in Encourage, women may participate in other diabetes
           prevention programming/weight management programming offered by other entities.
           Researchers will consent these women into the study to complete 3 data collection
           points, baseline, 4-6 months, and 12 months. Additionally, researchers will consent
           women to obtain data from their chosen program. For instance, if a woman chooses to do a
           Diabetes Prevention Program through the YMCA, researchers will ask women to self report
           their weekly attendance and weight.
    

Intervention name(s): Positive Outcomes for Women
Intervention type(s): Behavioral
Intervention description(s): Women and their children 10+ can consent to participate in the diabetes prevention programming offered through the research center. We will collect data at three time points, baseline, 4-6 months, and 12 months.
2. Instead of participating in Encourage, women may participate in other diabetes prevention programming/weight management programming offered by other entities. Researchers will consent these women into the study to complete 3 data collection points, baseline, 4-6 months, and 12 months. Additionally, researchers will consent women to obtain data from their chosen program. For instance, if a woman chooses to do a Diabetes Prevention Program through the YMCA, researchers will ask women to self report their weekly attendance and weight.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention