bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Rosiglitazone in Nondiabetic Patients With the Metabolic Syndrome
Condition: Metabolic Syndrome; Insulin Resistance
MeSH terms: Metabolic Syndrome; Insulin Resistance; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The metabolic syndrome is a collection of health risks that includes obesity, high blood
      pressure, high triglycerides, high blood sugar, low good cholesterol, and resistance to
      insulin. The purpose of this study is to find out if the medication, rosiglitazone,
      influences levels of fat cell proteins and alters insulin resistance in nondiabetic persons
      with the metabolic syndrome. This is an early step to see if a medication, such as
      rosiglitazone, will be beneficial in people who have the metabolic syndrome.
    


Intervention name(s): Rosiglitazone
Intervention type(s): Drug
Intervention MeSH terms: Rosiglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Effect of Food on the Pharmacokinetics of NNC0123-0000-0338 in a Tablet Formulation in Healthy Subjects
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of the trial is to investigate the effect of food
      on the pharmacokinetics (the exposure of the trial drug in the body) of NNC0123-0000-0338 in
      a tablet formulation in healthy subjects.
    


Intervention name(s): insulin 338 (GIPET I)
Intervention type(s): Drug
Intervention description(s): Each subject will be randomly allocated to a fixed treatment sequence of four single-dose administrations of oral insulin 338 in a GIPET® I tablet, administered on four separate dosing visits. The subjects will be dosed in the morning in the fasting state prior to four different post-dose fasting periods.
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dose Escalation, Safety and Pharmacokinetic Study of AVE8062 Combined With Cisplatin in Patients With Solid Tumors
Condition: Neoplasms, Malignant
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

        -  To determine the maximum tolerated dose based on the incidence of dose limiting toxicity
           and the maximum administered dose of ombrabulin in combination with cisplatin
           administered every 3 weeks in patients with advanced solid tumors.

      Secondary Objectives:

        -  To assess the overall safety profile of the combination therapy.

        -  To characterize the pharmacokinetic profile of ombrabulin, its active metabolite RPR
           258063, and cisplatin in combination.

        -  To evaluate anti-tumor activity of the combination therapy.
    

Detailed description: 
      The duration of the study for each patient will include an up to 4-week screening phase,
      21-day study treatment cycles, an end of treatment visit and a follow-up period 30 days after
      the last infusion of ombrabulin. The patient will continue treatment until disease
      progression, unacceptable toxicity, patient's refusal of further treatment.
    

Intervention name(s): ombrabulin (AVE8062); cisplatin
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form:injection solution
Route of administration: intravenous infusion; Pharmaceutical form: injection solution
Route of administration: intravenous infusion
Intervention MeSH terms: Cisplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Neoadjuvant S-1 and Concurrent Radiotherapy for Borderline Resectable Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Multicenter Prospective Phase II Study for Neoadjuvant S-1 and Concurrent Radiotherapy for
      Borderline Resectable Pancreatic Cancer

      RATIONALE: Borderline resectable pancreatic cancer is frequently related to a positive
      surgical margin and has a poor prognosis after resection. Neoadjuvant chemoradiation with
      intensive local effect may lead to substantial local control and prolongation of survival in
      borderline resectable pancreatic cancer.

      PURPOSE: This phase II trial assess efficacy and safety of neoadjuvant S-1 and concurrent
      radiotherapy for borderline resectable pancreatic cancer.
    

Detailed description: 
      S-1: S-1 is an oral fluorinated pyrimidine agent which contains tegafur (FT, a prodrug of
      5-FU), 5-chloro-2,4-dihydropyrimidine (CHDP) and potassium oxonate (Oxo) effective for
      gastric and various other types of cancers. S-1 is also active for pancreatic cancer: S-1
      demonstrated non-inferiority to gemcitabine in overall survival for metastatic or locally
      advanced pancreatic cancer (LAPC).

      S-1 and Concurrent radiotherapy: S-1 therapy with concurrent radiation therapy (RT) had
      favorable activity with overall tumor response rate of 37%, as well as mild toxicity in
      patients with LAPC. The median survival time and the 2-year survival rate for LAPC patients
      treated by S-1/RT were 16.2 months and 26% respectively.

      Definition of Borderline Resectable Pancreatic Cancer:(1) Reconstructible bilateral
      impingement of superior mesenteric vein or portal vein; (2) Tumor contact with the superior
      mesenteric artery (SMA) of </= 180 degrees ; (3) Tumor contact with the common hepatic artery
      of </= 180 degrees (at the root of the gastroduodenal artery); and (4) Tumor contact with the
      celiac axis of </= 180 degrees.

      Tumor with portal vein tumor thrombus and tumor contact with the second or further jejunal
      SMA branch are considered as unresectable. Tumor which is contact with the common hepatic
      artery or celiac axis but can be resected by distal pancreatectomy with en bloc celiac axis
      resection, is not included in this study.
    

Intervention name(s): S-1; Radiation Therapy
Intervention type(s): Drug; Radiation
Intervention description(s): S-1 is administered orally at a dose of 40 mg/m2 twice daily on the day of irradiation (Monday through Friday) during radiation therapy.; Radiation therapy is delivered with >6-megavolts (MV) photons, using a multiple field technique. A total dose of 50.4 Gy is delivered in 28 fractions over 5.5 weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Borderline Resectable Pancreatic Cancer
Sulindac in Preventing Breast Cancer in Women at High Risk for Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing,
      or coming back. The use of sulindac may prevent breast cancer.

      PURPOSE: This randomized phase I trial is studying the effects of sulindac, to prevent breast
      cancer, in women at high risk for breast cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the partitioning of sulindac and its metabolites in women at high risk for
           breast cancer by measuring drug and metabolite levels in nipple aspirate fluid (NAF)
           after 6 weeks of therapy.

      Secondary

        -  Determine prostaglandin levels in the NAF of patients treated with this drug.

        -  Determine if NAG-1 levels are induced in the NAF of patients treated with this drug.

        -  Determine if C-reactive protein levels are reduced in the NAF of patients treated with
           this drug.

        -  Determine if NAG-1 levels and/or karyometric features in ductal epithelial cells are
           modulated in patients treated with this drug.

      OUTLINE: This is a randomized, open-label study.

      Patients undergo nipple aspirate fluid (NAF) collection. Patients are then randomized to 1 of
      2 treatment arms.

        -  Arm I: Patients receive oral sulindac once daily.

        -  Arm II: Patients receive oral sulindac twice daily. In both arms, treatment continues
           for 6 weeks in the absence of disease progression or unacceptable toxicity. All patients
           then undergo a second NAF collection.

      After completion of study treatment, patients are followed at 2 weeks.

      PROJECTED ACCRUAL: A total of 30 patients (15 per treatment arm) will be accrued for this
      study.
    

Intervention name(s): sulindac; laboratory biomarker analysis
Intervention type(s): Drug; Other
Intervention MeSH terms: Sulindac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: breast cancer; ductal breast carcinoma in situ; lobular breast carcinoma in situ; breast cancer in situ
Efficacy of Hypnotherapy in Children With Dental Anxiety
Condition: Dental Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Dental anxiety is a common problem among the children. The aim of this study is to evaluate
      the efficacy of hypnotherapy in children with dental anxiety. The participants will be
      randomized in a 1:1 ratio to hypnotherapy or control group. The outcome measures will be
      Modified Children Dental Anxiety Scale-faces version(MCDAS(f)) and Visual Analogue
      Scale(VAS).
    


Intervention name(s): Hypnotherapy
Intervention type(s): Behavioral
Intervention description(s): Hypnotherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: dental anxiety; hypnotherapy; pediatric dentistry
Quantitive LGE Mass in Prediction of SCD in NICM Patients With Severe Cardiac Dysfunction
Condition: Cardiomyopathy
MeSH terms: Cardiomyopathies
Study type: Observational

Summary: 
      The purpose of this study is to establish a quantitative LGE mass based scoring system
      (including LGE mass on cardiac magnetic resonance , clinical features, specific medical
      histories, et al) for risk prediction of sudden cardiac death in non-ischemic dilated
      cardiomyopathy patients with reduced left ventricular ejection fraction
    

Detailed description: 
      This is a Single-centered, Prospective, Observational Study. The study design included two
      phases. In Phase I, the investigators enrolled a set of consecutive patients with
      non-ischemic cardiomyopathy who performed contrast-enhanced cardiac magnetic resonance at
      baseline and had severe cardiac dysfunction (defined as cardiac magnetic resonance LVEF equal
      or less than 35% ) in FuWai Hospital from 2010 to 2013. The investigators collect patients'
      clinical baseline data and cardiac magnetic resonance specific data(Late gadolinium
      enhancement mass). All patients were followed up every six month by phone or clinical visits.
      The primary endpoint was composite of sudden cardiac death(SCD), ventricular arrhythmias(VAs)
      and SCD/VAs related Implantable Cardioverter defibrillator or cardiac resynchronization
      therapy-cardioverter defibrillator(ICD/CRTD) shock. The investigators plan to establish a
      quantitative LGE mass based model (including LGE mass on cardiac magnetic resonance, clinical
      features, specific medical histories, et al) for risk prediction of sudden cardiac death by
      analysing the phase I data(1-year model and 3-year model). In Phase II,the investigators will
      enroll another group of non-ischemic cardiomyopathy(NICM) patients from 2014 to 2015 to
      testify the risk prediction model(1-year model) the investigators have constructed in phase
      I. The investigators aim to find the real high risk NICM patients that may suffer from SCD or
      VAs in those with severe cardiac dysfunction.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Chinese patients with non-ischemic cardiomyopathy
      
Keywords: sudden cardiac death; ventricular arrhythmias; cardiopathy; late gadolinium enhancement
Examining the Neural Effects of a Behavioral Intervention for Physical Activity in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      Multiple sclerosis [MS] is a prevalent neurological disease that is the leading cause of
      irreversible neurological disability among young women and the second leading cause of
      disability among young men in the United States. This disease results in the progressive loss
      of walking mobility and substantial worsening of cognition, symptoms, and quality of life
      over time. There is evidence that physical activity is beneficially associated with aerobic
      fitness and brain structure and function in persons with MS. Nevertheless, this population is
      strikingly sedentary and physically inactive. This highlights a vital opportunity to improve
      aerobic fitness and brain health by developing behavioral interventions that increase
      physical activity. To that end, this project is a Phase-II randomized control trial for
      examining the efficacy of a behavioral intervention that is based on social-cognitive theory
      and delivered through the Internet for increasing physical activity and, secondarily,
      improving aerobic fitness and brain structure and function in persons with MS.
    


Intervention name(s): Behavioral Intervention for Physical Activity in MS (BIPAMS); Wellness for MS (WellMS)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A behavioral intervention that involves an Internet website and one-on-one video coaching calls for increasing physical activity in people with MS.; A behavioral intervention that involves an Internet website and one-on-one video coaching calls for increasing wellness in people with MS.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: physical activity
Acute Food INtake Effect of Hemp Protein (A FINEH Protein) Trial - Part 2
Condition: Diabetes Prevention; Obesity Prevention
Study type: Interventional

Summary: 
      The objectives of this trial are to investigate whether the effects of hemp protein on
      glycemic and appetite control are insulin-dependent by measuring 1) blood glucose, insulin
      and appetite for one hour following consumption, 2) blood glucose, insulin and appetite
      following a fixed energy meal to determine the "second meal effect" of hemp protein versus
      soybean protein and a non-protein control.
    

Detailed description: 
      The objectives of this trial are to investigate whether the effects of hemp protein on
      glycemic and appetite control are insulin-dependent by measuring 1) blood glucose, insulin
      and appetite for one hour following consumption, 2) blood glucose, insulin and appetite
      following a fixed energy meal to determine the "second meal effect" of hemp protein versus
      soybean protein and a non-protein control. The objectives of this trial are to investigate
      whether the effects of hemp protein on glycemic and appetite control are insulin-dependent by
      measuring 1) blood glucose, insulin and appetite for one hour following consumption, 2) blood
      glucose, insulin and appetite following a fixed energy meal to determine the "second meal
      effect" of hemp protein versus soybean protein and a non-protein control.
    

Intervention name(s): Hemp Shake; Hemp; Soybean Shake; Soybean; Control
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Hemp Protein; Hemp Protein Shake; Soybean Protein; Soybean Protein Shake; Non-Protein Shake
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Genotype, Metabotype and Diet in a Cohort of Children and Adolescents From the Southeast of Spain.
Condition: Genotype, Metabotype and Dietary Habits
Study type: Interventional

Summary: 
      The objective of this study is to investigate the possible association between 60 SNPs
      related to obesity, metabolism and cardiovascular disease with BMI, intestinal microbiota and
      adherence to the Mediterranean diet in a cohort of children and adolescents from the
      southeast of Spain.
    

Detailed description: 
      The objective of this study is to investigate the possible association between 60 single
      nucleotide polymorphisms (SNPs) related to obesity, metabolism and cardiovascular disease
      with the body mass index (BMI), intestinal microbiota related to the metabolism of
      polyphehnos and adherence to the Mediterranean diet in a cohort of children and adolescents
      from the southeast of Spain.

      The volunteers (n=423) with ages ranging from 5 to 18 years consumed for three days a daily
      serving of walnuts (30g) and provided a sample of urine (to determine mirobial-derived
      metabolites from walnut polyphenols) as well as a swab specimen from the inner cheek to
      provide DNA for further genotyping.
    

Intervention name(s): Walnuts; Pomegranate juice
Intervention type(s): Other; Other
Intervention description(s): The group consumed a daily serving of walnuts (30 g) or 200 mL pomegranate juice for 3 days and provided a sample of urine as well as a swab specimen from the inner cheek; Those volunteers who were allergic to nuts consumed 200 mL pomegranate juice daily for 3 days and provided a sample of urine as well as a swab specimen from the inner cheek
Other intervention name(s): Intake of walnuts; Intake of pomegranate juice
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Is Virtual Reality a Non-pharmacological Premedication?
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Observational

Summary: 
      Preoperative anxiety of patients who will undergo septorhinoplasty surgery will be measured
      and their hemodynamic parameters will be recorded afterwards. Then, a video will be shown to
      the patients through virtual reality glasses and the effect of this application on their
      anxiety will be investigated.
    


Intervention name(s): anesthesiologist
Intervention type(s): Other
Intervention description(s): non-interventional observational
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients between the ages of 18-65 who will undergo septorhinoplasty surgery
      
Keywords: Virtual Reality; Anxiety; Premedication
The Efficacy of a 6-point Transscleral Suture Fixation of a 3-looped Haptics PC-IOL Implantation Through Scleral Pockets for Surgical Management for Microspherophakia
Condition: Microspherophakia
MeSH terms: Corneal Diseases; Ectopia Lentis; Glaucoma
Study type: Observational

Summary: 
      By comparing the preoperative data and postoperative data of 9 patients of microspherophakia,
      we concluded that the 6-point transscleral suture fixation of a 3-looped haptics posterior
      chamber intraocular lens (PC-IOL) through scleral pockets was a feasible method of PC-IOL
      implantation in the surgical treatment of microspherophakia.
    


Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        A retrospective study was conducted on 9 patients (18 eyes) diagnosed with
        microspherophakia in Eye Center of the Second Affiliated Hospital, Zhejiang University
        School of Medicine from July 2016 to April 2020.
8mm-TIPS Versus Endoscopic Variceal Ligation (EVL) Plus Propranolol for Prevention of Variceal Rebleeding
Condition: Portal Hypertension
MeSH terms: Hypertension, Portal
Study type: Interventional

Summary: 
      The aim of this study was to conduct a prospective randomized trial to compare TIPS with 8mm
      expanded polytetrafluoroethylene(ePTFE)-covered stents and endoscopic variceal ligation plus
      propranolol for the prevention of recurrent esophageal variceal bleeding.
    

Detailed description: 
      For the prevention of recurrent esophageal variceal bleeding, previous clinical studies and
      meta-analysis show that patients treated with transjugular intrahepatic portosystemic shunt
      (TIPS) have lower rebleeding rates compared with endoscopic therapy. However, TIPS is
      associated with higher rates of portosystemic encephalopathy and does not show survival
      benefit. TIPS with a small-diameter may achieve sufficient portal decompression and reduce
      the incidence of hepatic encephalopathy. The aim of this study was to conduct a prospective
      randomized trial to compare TIPS with 8mm ePTFE-covered stents and endoscopic variceal
      ligation plus propranolol for the prevention of recurrent esophageal variceal bleeding.
    

Intervention name(s): 8mm-TIPS; Endoscopic variceal ligation; Propranolol; 8mm ePTFE-covered stent
Intervention type(s): Procedure; Procedure; Drug; Device
Intervention MeSH terms: Propranolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of the Pharmacokinetics of Two Generic Antidepressants and Their Respective Brand Preparations
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Generic medications should be the equivalent of brand medications with the exception of their
      price. Before a generic medication is introduced, its bioequivalence within a window of 80 to
      125% of the original has to be demonstrated. There are reports that this criterion is not
      always followed in post-marketed periods. Such investigations were triggered by the
      observation that some patients previously stable on original medications relapsed when
      switched to a presumable equivalent generic. Several factors could account for this problem.
      Given reports of such problems occurring with the antidepressants citalopram and venlafaxine,
      some pharmacokinetic properties of specific brands of generics and the originals will be
      examined for these two medications. Twelve healthy male volunteers will participate in this
      crossover study. It is anticipated that there will be significant differences emerging
      between the two formulations given the clinical reports of patients deteriorating when
      switched from the original to the generic preparations.
    


Intervention name(s): Venlafaxine; Gen-Citalopram; Effexor XR; Celexa
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): NOVO-Venlafaxine XR 75 mg (NOVOPHARM, Generic); Gen-Citalopram 40 mg (Genpharm, Generic); Effexor XR 75 mg (Wyeth Pharmaceuticals, Brand Name); Celexa 40 mg (Lundbeck, Brand Name)
Intervention MeSH terms: Venlafaxine Hydrochloride; Citalopram
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Therapeutic Equivalency; Human Experimentation; Bioequivalence; Brand name; Generic; Antidepressant; Healthy volunteers
Bioequivalency Study of Montelukast 10 mg Tablets Under Fasted Conditions
Condition: Asthma
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The objective of this study was to prove the bioequivalence of Montelukast Tablet under
      fasted conditions
    


Intervention name(s): Montelukast; Singulair
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg Tablet; 10 mg Tablet
Other intervention name(s): Singulair; Montelukast
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment