bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Tolerability Study of V501 in Japanese Boys (V501-200)
Condition: Anogenital Human Papilloma Virus Infection; Condyloma Acuminata
MeSH terms: Papillomavirus Infections; Papilloma
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a study of V501 [quadrivalent Human Papillomavirus (HPV) (Type 6, 11, 16 and 18) L1
      virus-like particle (VLP) vaccine] in healthy Japanese boys. This study will consist of two
      periods. Period I of the study is to evaluate the immunogenicity and tolerability of V501 up
      to Month 7. Period II of the study is to evaluate the long-term immunogenicity and safety
      from Month 7 to Month 30. Two analyses are planned. The first analysis will be conducted when
      all subjects have completed their Month 7 visit or have been discontinued before that time.
      The second analysis will be conducted at the end of study. The primary hypothesis tested in
      this study is that seroconversion rates for the vaccine HPV types will be >90% at 4 weeks
      postdose 3.
    


Intervention name(s): V501
Intervention type(s): Biological
Intervention description(s): Quadrivalent HPV [Type 6, 11, 16 and 18] L1 VLP vaccine), 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6
Other intervention name(s): Gardasil™
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK2330672 in Type 2 Diabetes Patients Taking Metformin
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      Metformin may have complex interactions in the gut and is generally first line therapy for
      type 2 diabetes mellitus (T2DM). It is important to understand whether there are significant
      pharmacokinetic or pharmacodynamic interactions when GSK2330672 is co-administered with
      metformin in subjects with T2DM. The purpose of this study is to investigate the safety and
      tolerability of GSK2330672 administered for 7 days to subjects with T2DM taking metformin.
      This will be a two-period crossover study; subjects will receive either GSK2330672 or placebo
      for 7 days in each period separated by a washout period of 13 to 15 days. All subjects will
      receive metformin throughout the study
    


Intervention name(s): GSK2330672; Placebo; Metformin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): GSK2330672 will be supplied as oral solution, and will be administered BID [45 mg (2 days repeat dose) and 90 mg (5 days repeat dose) in each period]; GSK2330672 matching placebo will be supplied as oral solution, and will be administered BID (7 days of dosing in each period); Metformin 850 mg will be administered BID from Run-in period till Day 7 of period 2
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Metformin; Diabetes
Effects of Cranberry Consumption in Vascular Function in Healthy Individuals
Condition: Healthy Men
Study type: Interventional

Summary: 
      Accumulating evidence from epidemiological and human intervention studies indicates that the
      cardiovascular health benefits of diets rich in fruits and vegetables are (in part) related
      to their (poly)phenol content. Cranberries are rich in (poly)phenols compounds, in particular
      anthocyanins, but also phenolic acids. At present, a small number of randomized controlled
      trials investigating the effects of berry (poly)phenols on validated surrogate markers of
      cardiovascular disease risk has shown promising results. However, to date, very few human
      studies have specifically investigated the effects of cranberry (poly)phenols on
      cardiovascular function in healthy subjects. To our knowledge, no study has investigated the
      time and intake-dependent effect of cranberry consumption on vascular function in healthy
      subjects. This information is necessary for the planning of long-term studies aiming to
      assess the potential beneficial effects of cranberries, using optimal amounts at optimal time
      points. Therefore, this study aims to investigate the potential role of cranberry
      (poly)phenols in the modulation of vascular function by monitoring changes in vascular
      function together with the major (poly)phenol derivatives/metabolites in plasma and urine.
    


Intervention name(s): Cranberry 320; Cranberry 640; Cranberry 960; Cranberry 1280; Cranberry 1600; Cranberry deprived supplement
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Dietary Supplement: Cranberry beverage with 320 mg of (poly)phenols Acute intake of 500 mL (1x daily); Dietary Supplement: Cranberry beverage with 640 mg of (poly)phenols Acute intake of 500 mL (1x daily); Dietary Supplement: Cranberry beverage with 960 mg of (poly)phenols Acute intake of 500 mL (1x daily); Dietary Supplement: Cranberry beverage with 1280 mg of (poly)phenols Acute intake of 500 mL (1x daily); Dietary Supplement: Cranberry beverage with 1600 mg of (poly)phenols Acute intake of 500 mL (1x daily); Cranberry deprived supplement Acute intake of 500 mL (1x daily)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: polyphenols; vascular function; endothelial function; cranberry; healthy
Effect of Exercise on Cardiometabolic Risk Factors in Type II Diabetic Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Background: Physical activity is known to modify some of the diabetes risk factors; however,
      solid evidence is still needed to precisely know the optimum form of training best fits the
      individual needs of type II diabetic (T2D) patients.
    

Detailed description: 
      Objectives: the purpose of this study was to compare between high intensity interval training
      (HIIT) and moderate-intensity interval training (MIIT) effect on functional capacity (as a
      cardiorespiratory parameter), and on glucose control and glycated hemoglobin (HbA1C) (as
      metabolic parameters) in T2D patients, and to test exercise acceptability within these
      patients. Methods: 60 participants had participated in this study. Their ages ranged from 45
      to 65 years. They were randomized into two equal groups (30/group); group (A) did HIIT and
      group (B) did MIIT. Both groups received 12 weeks of training. Measurements for six minute
      walking distance (6MWD), fasting blood glucose (FBG), and HbA1C levels were done before and
      after the study. Physical activity enjoyment scale (PACES) were filled by the patients by the
      end of the study; testing exercise enjoyment.
    

Intervention name(s): High-intensity interval training; Moderate intensity interval training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): High-intensity interval training is a form of intermittent training using relatively high exercise intensity; Moderate intensity interval training is a form of intermittent training using moderate exercise intensity
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: Type II diabetes; cardiometabolic risk; high-intensity interval training
A Study of the Effects of Sitagliptin (MK0431) and Metformin on Incretin Hormone Concentrations (0431-050)(COMPLETED)
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will determine the effect of concomitant administration of sitagliptin and
      metformin on post-meal incretin hormone concentrations in healthy adults.
    


Intervention name(s): sitagliptin phosphate; Comparator: metformin; Comparator: sitagliptin and metformin; Comparator: placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 100 mg sitagliptin daily for two days in one out of four treatment periods; 500 mg twice daily on Day 1 and 1000 mg once daily on Day 2 in one of four treatment periods.; 100 mg sitagliptin once daily and 500 mg metformin twice daily on Day 1 and 100 mg sitagliptin once daily and 1000 mg metformin once daily on Day 2 in one of four treatment periods.; Placebo only on Days 1 and 2 in one of four treatment periods.
Intervention MeSH terms: Metformin; Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
RCT - Assessing the Benefits of the Use of a Tension Night Splint in Patients With Plantar Fasciitis
Condition: Plantar Fasciitis
MeSH terms: Fasciitis; Fasciitis, Plantar
Study type: Interventional

Summary: 
      To assess whether the provision of a tension night splint (TNS) device has any additional
      benefit in patients with chronic plantar fasciitis, compared to routine care comprising
      physiotherapy & podiatry alone.
    


Intervention name(s): tension night splint; standard practice - a structured rehabilitation programme
Intervention type(s): Device; Other
Intervention description(s): this is the use of a commercially available tension night splint device, to be worn by the patient; this is the standardised structured rehabilitation programme of home exercises given to patients, with supporting literature, and instructions on how to progress the regime themselves
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Bioinformation Therapy for Breast Cancer
Condition: Advanced Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of this study is the synergistic effect of cancer ablation and life information
      rehabilitation therapy on unresectable breast cancer.
    

Detailed description: 
      By enrolling patients with unresectable breast cancer adapted to enrolled criteria, this
      study will document for the first time the synergistic effect of cancer ablation and life
      information rehabilitation therapy. The efficacy will be evaluated according to local relief
      degree, progress free survival (PFS) and overall survival (OS).
    

Intervention name(s): Cancer ablation; Life information rehabilitation therapy
Intervention type(s): Device; Drug
Intervention description(s): Tumors bigger than 2 cm are fit for ablation therapy, percutaneously under CT scan or ultrasound.; Each treatment: one bottle solution each day, consecutive 3 months, oral administration
Other intervention name(s): Cryoablation or irreversible electroporation; "Qilisheng" Immunoregulatory Oral Solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cancer ablation; Life information rehabilitation therapy
Effectiveness and Safety of Adding Compound Preparation of Pioglitazone and Metformin for Type 2 Diabetic Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Secondary failure of sulfonylureas (SUs) can occur in about 30%-40% of type 2 diabetic
      patients after treatment with SUs for 5 years, although SUs are widely used in type 2
      diabetic patients. This study was designed to evaluate the effectiveness and safety of adding
      compound preparation of pioglitazone and metformin for type 2 diabetic patients who have bad
      glycemic control with the initial treatment of SUs.
    

Detailed description: 
      Design of this clinical trial was multicenter, randomized, double-blind and placebo parallel
      controlled. Type 2 diabetic patients having bad glycemic control with the initial treatment
      of SUs were included. They were randomly divided into experiment group and control group,
      respectively taking compound preparation of pioglitazone and metformin (2mg/500mg) and
      placebo with identical shape immediately before a meal twice a day. Course of the treatment
      was 12 weeks.
    

Intervention name(s): Pioglitazone and Metformin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): taking 1 tablet twice a day (before breakfast and before dinner) orally for 12 weeks; taking 1 tablet twice a day (before breakfast and before dinner) orally for 12 weeks
Other intervention name(s): Compound Preparation of Pioglitazone and Metformin; Kashuangping; H20100180
Intervention MeSH terms: Metformin; Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pioglitazone; Metformin; Type 2 Diabetes Mellitus
Evaluate the Efficacy and Safety of Activated T-lymphocyte Cell Therapy in Advanced Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Phase 2 Clinical trial to Evaluate the efficacy and safety of activated T-lymphocyte
      ("Immuncell-LC") cell therapy in Gemcitabine refractory advanced pancreatic cancer
    

Detailed description: 
      This was designed as a single-center, single group clinical trial, and subjects include
      patients with pathologically-confirmed Gemcitabine refractory advanced pancreatic cancer.

      If subjects agree to participate in the clinical trial by signing a written consent, only
      appropriate subjects, who meet the criteria on the examinations and tests, will undergo this
      clinical trial. To participate in the clinical trial, subject's blood of more than 60 ml
      should be withdrawn to make a study drug at least 2 weeks before administration. Subjects
      should visit to hospital according to the protocol and receive a study drug. Therapeutic
      response rate, overall survival rate, time to progression and the quality of life should be
      investigated.
    

Intervention name(s): Activated T lymphocyte
Intervention type(s): Biological
Intervention description(s): Intravenous dripping of 200 ml (109~2 1010 lymphocytes/60 kg adult) for 1 hour.
Other intervention name(s): Immuncell-LC
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: advanced pancreatic cancer
Chronic Asthma Study in 2- to 5-Year-Old Patients (MK0476-072 )
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      A study in 2-5 year old children to evaluate the safety and tolerability of montelukast and
      placebo administered once daily at bed time.
    


Intervention name(s): montelukast sodium; Comparator: Placebo
Intervention type(s): Drug; Drug
Intervention description(s): one chewable 4-mg montelukast tablet, once daily at bedtime for 12 weeks; one chewable placebo tablet, once daily at bedtime for 12 weeks
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
An Extension of the TG1101-RMS201 Trial
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the long term use of a single agent ublituximab, a novel monoclonal
      antibody, in patients with relapsing forms of multiple sclerosis
    


Intervention name(s): Ublituximab
Intervention type(s): Biological
Intervention description(s): Enrolled Subjects will be infused with ublituximab on Weeks 1E, 24E, 48E, 72E and 96E
Other intervention name(s): TG1101
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Relapsing Multiple Sclerosis
Effect of GnRH Agonist vs GnRH Antagonist on IVF/ICSI Outcomes in Polycystic Ovary Syndrome Patients.
Condition: In Vitro Fertilization; Intracytoplasmic Sperm Injection; Infertility; Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Infertility; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      This prospective, non-randomised, open-label, clinical trial is conducting on polycystic
      ovary syndrome (PCOS) subjects to compare the effects of two pituitary suppression regimens;
      GnRH Agonist-Long Protocol and GnRH Antagonist-Flexible Protocol on clinical and
      embryological IVF/ICSI outcomes, and on the follicular fluid levels of Placental Growth
      Factor (PlGF); which is known for his pivotal role in the regulation of ovulation, embryo
      development, and implantation
    


Intervention name(s): Triptorelin acetate; Cetrorelix; recombinant-FSH or recombinant-FSH + human Menopausal Gonadotropin; Human Chorionic Gonadotropin (hCG)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 0.05-0.1 mg subcutaneously (SC) once daily from the mid-luteal phase (day 21) of the cycle until the day of ovulation triggering.; 0.25 mg subcutaneously (SC) once daily starting from the day detecting a leading follicle diameter ≥ 14 mm until the day of ovulation triggering.; Dosage adjustment according to the ovarian response.; Ovulation will be triggered by the administration of 10,000 IU of Human Chorionic Gonadotropin (hCG) when at least three follicles become more than 16-17 mm.
Intervention MeSH terms: Triptorelin Pamoate; Chorionic Gonadotropin; Cetrorelix; Menotropins
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GnRH Agonist; GnRH Antagonist; Assisted reproduction technique; In Vitro Fertilization; Intracytoplasmic sperm injection; Polycystic Ovary Syndrome; Placental growth factor
Study of ARO-ANG3 in Healthy Volunteers and in Dyslipidemic Patients
Condition: Dyslipidemias; Familial Hypercholesterolemia; Hypertriglyceridemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia; Dyslipidemias; Hypertriglyceridemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetcs and
      pharmacodynamics of single- and multiple doses of ARO-ANG3 in healthy adult volunteers and in
      dyslipidemic patients including familial hypercholesterolemia and severe
      hypertriglyceridemia.
    


Intervention name(s): ARO-ANG3; sterile normal saline (0.9% NaCl)
Intervention type(s): Drug; Drug
Intervention description(s): single or multiple doses of ARO-ANG3 by subcutaneous (sc) injections; calculated volume to match active treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Lifestyle Interventions for Seniors With Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      The overall goal of this study is to determine the efficacy of a lifestyle intervention,
      consisting of a weight loss diet and exercise on sleep apnea in older adults. The
      investigators will conduct a 3-month intervention in men and women who are sedentary with
      suspected sleep apnea. The investigators hypothesize that the intervention will lead to
      marked improvements in sleep apnea severity and cardiovascular risk markers.
    

Detailed description: 
      Frailty, a condition characterized by a decrease in physiological reserve and increased risk
      for adverse health-related outcomes, is an increased risk of aging, especially in the
      presence of co-morbid conditions. Sleep apnea is also highly prevalent with increasing age.
      Both conditions share common pathologies, suggesting that sleep apnea may increase the risk
      of developing or exacerbate the consequences of frailty. Lifestyle interventions as
      strategies for treating sleep apnea and associated co-morbidities, thereby highlighting a
      feasible approach by which to reduce the incidence or progression of frailty. The specific
      aims of this study are to: 1) determine the effectiveness of a lifestyle intervention (LI),
      consisting of a weight loss diet and supervised exercise, on reducing sleep apnea in older
      adults, and 2) determine whether this intervention is effective at improving parameters that
      are common to both sleep apnea and frailty, such as poor physical functional capacity and
      body composition, impaired or abnormal cardiometabolic function and increased levels of
      inflammation.
    

Intervention name(s): Lifestyle Intervention
Intervention type(s): Behavioral
Intervention description(s): Participants undergo 3 months of monitored exercise, consisting of aerobic and resistance training (3 days per week for 1 hour). Participants will also meet with a registered dietician, who will prescribe an American Heart Association low fat diet. The goal is to achieve a 1-2 lb weight loss per week.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: weight loss; exercise; diet; sleep apnea; aging
Sponge and Eosinophil Peroxidase (EPO) Staining
Condition: Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Study type: Interventional

Summary: 
      Are we able to use the EPO staining technique using the sponge ?
    

Detailed description: 
      EPO staining on esophageal sponge samples had a strong association with peak esophageal
      eosinophil counts on endoscopic biopsy specimens in a small study of 26 patients Using a
      cut-off of 1.1 absorbance units in a colorimetric assay at a wavelength of 492nm the EPO
      stain had sensitivity and specificity of 1105 and 83% respectively for a peak eosinophil
      count of 15 eos/hpf on histologic endoscopic obtained biopsy specimens. The technique of EPO
      staining is standardized and can be completed in 45 minutes time. Currently, we have found
      esophageal sponge cytology sensitive and specific for assessment of esophageal eosinophilia.
      It allows disease activity assessment without endoscopy is much preferred by patients over
      the standard endoscopic technique of disease assessment. The process of specimen preparation
      in fairly tedious and interpretation takes significant experience. If EPO staining on
      non-endoscopic esophageal sponge studies was accurate at assessing disease activity, this is
      a tool that could be easily performed and interpreted with a rapid turnaround time.
    

Intervention name(s): swallowed sponge device
Intervention type(s): Device
Intervention description(s): Swallowed sponge: Subjects having a clinical upper endoscopy will be asked to swallow the sponge 2 hours prior to EGD
Other intervention name(s): brush
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: EoE