bioihbjkbjnl/mcl2 huggingface dataset:
(CB-01-02/04) Extension Study of Budesonide Multi-Matrix System (MMX) 6 mg in Maintenance Of Remission In Patients With Ulcerative Colitis.
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      Randomized, double-blind, comparative study versus placebo performed in patients from studies
      CB-01-02/01 (NCT00679432), CB-01-02/02 (NCT00679380), or CB-01-02/06 (NCT01100112) who
      achieved ulcerative colitis disease activity index (UCDAI) remission after 8 weeks of
      treatment.

      Patients in remission at the End of Study visit will be given the opportunity to enter the
      12-month Maintenance Phase study outlined in this protocol (CB-01-02/04). The End of Study
      visit in studies 01, 02, and 06 will be set as the Visit 1 (Day 0) of this study. There will
      be no interruption of study treatment between the parent studies and this study.

      It is planned that approximately 150 patients will be enrolled in the study. Patients will be
      randomly assigned to two groups to receive either budesonide MMX 6 mg or placebo irrespective
      of the treatment assigned in studies 01, 02, or 06. Treatments will be administered once a
      day after breakfast for a maximum of 12 months or up to the occurrence of the first clinical
      relapse, where clinical relapse is defined as combined recurrence of rectal bleeding and
      stool frequency ≥ 1-2 stools/day above normal for the patient (score ≥ 1 in both UCDAI
      items).

      During the study, patients will be assessed for safety and efficacy at Visit 1 and after 1,
      3, 6, 9, and 12 months of treatment.

      Patients will be contacted by telephone on a monthly basis for safety assessment. In case of
      occurrence of symptoms suggestive of clinical relapse, patients will attend an unscheduled
      visit at any time during the study.
    


Intervention name(s): Budesonide MMX 6 mg Tablet; Placebo Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Budesonide MMX 6 mg Tablet once daily.; Placebo Tablet once daily.
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ulcerative Colitis
E-Cigarettes and SNA
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      Randomized controlled trial of electronic cigarettes with nicotine, without nicotine, and
      sham control, on sympathetic nerve activity and markers of oxidative stress.
    

Detailed description: 
      Participants will use an electronic cigarette on 3 occasions: 1) with nicotine, 2) without
      nicotine, 3) sham control, and measures of autonomic tone, including heart rate variability
      (HRV) and sympathetic nerve activity (MSNA: microneurography), and oxidative stress will be
      measured pre and post exposure.
    

Intervention name(s): one time exposure to e-cig with nicotine; One time exposure to e-cigarette without nicotine; one time exposure to empty e-cigarette
Intervention type(s): Other; Other; Other
Intervention description(s): one time exposure to e-cigarette vapor with nicotine; One time exposure to e-cig without nicotine; one time exposure to empty e-cigarette (sham control)
Other intervention name(s): sham control
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: nicotine; autonomic tone; oxidative stress
A Phase Ia/Ib Study of CS1001 in Subjects With Advanced Solid Tumors
Condition: Advanced Cancer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase Ia/Ib, open-label, multiple-dose, dose-escalation and expansion study to
      evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of CS1001 in
      subjects with advanced solid tumors.
    


Intervention name(s): CS1001
Intervention type(s): Drug
Intervention description(s): In the dose escalation part, the dose levels will be escalated following a modified 3+3 dose escalation scheme.
In the dose expansion part, patients will be assigned to different groups based on their tumor type.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Placebo-Controlled Trial of Pregabalin (Lyrica) for Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is being done to see if Lyrica helps people with irritable bowel syndrome.
    

Detailed description: 
      Lyrica is the trade name for pregabalin, which was first approved by the FDA in June 2005 and
      has been available through prescription since fall 2005, and is marketed by Pfizer. Lyrica is
      known to have clinical efficacy treating pain disorders including irritable bowel
      syndrome-related conditions such as fibromyalgia.
    

Intervention name(s): Pregabalin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dose: 75 mg twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study.; A matching placebo will be administered twice a day
Other intervention name(s): Lyrica
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Efficacy of Oral Famciclovir Versus Aciclovir Treatment in Patients With Herpes Zoster
Condition: Herpes Zoster
MeSH terms: Herpes Simplex; Herpes Zoster
Study type: Interventional
Phase: Phase 3

Summary: 
      Herpes Zoster is an infection that affects part of the nervous system caused by Varicella
      Zoster Virus. Herpes Zoster manifests as vesicular eruption in the dermatome, often
      associated with significant pain.

      There are effective oral prescription antiviral medicines available to reduce the discomfort
      of symptoms as famciclovir and aciclovir.

      This is a phase III, multicenter, randomized, parallel-group study to compare the efficacy
      and safety of treatment with Famciclovir (500 mg) comparing to Aciclovir (400 mg) in patients
      with Herpes Zoster.
    

Detailed description: 
      Study Design

        -  single blind study, prospective, parallel group, intent to treat trial

        -  Experiment duration: 7 days

        -  2 visits (days 0, and 7)

        -  Reduction of symptoms

        -  Adverse events evaluation
    

Intervention name(s): Famciclovir; Aciclovir
Intervention type(s): Drug; Drug
Intervention description(s): Famciclovir 500 mg- 1 tablet each 12 hours for 7 days; Aciclovir 400 mg- 02 tablets each 4 hours for 7 days
Intervention MeSH terms: Acyclovir; Famciclovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Comparison of Tai Chi and Pulmonary Rehabilitation on the Effect of Indacaterol in Treatment naïve COPD Participants
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      Tai-Chi may be a beneficial form of rehabilitation which is acceptable to the Chinese
      population but no data exist concerning metabolic responses to Tai-Chi in COPD patients.
      Investigators conduct an Randomized controlled trial to evaluate the synergistic effect of a
      Long acting β2-agonists with Tai-Chi as a culturally acceptable form of PR in the Asian
      population. Classical western style pulmonary rehabilitation will serve as a comparator
      Investigators propose a prospective randomized controlled trial in which 120 bronchodilator
      naïve participants (Age 40-80 with GOLD II-IV COPD (post-bronchodilator FEV1 ≥ 25% and <80 %
      of the predicted normal, and a post-bronchodilator FEV1/FVC < 0.70) are randomized to receive
      a 26 weeks course of Indacaterol with either Tai-Chi or conventional Pulmonary
      Rehabilitation. Only participants who are residents in Xingning city (Guangdong Province,
      China) will be recruited.

      Both Tai-Chi and pulmonary rehabilitation will be given by qualified instructors at a rural
      location in southern China (Xingning). A qualified UK Physiotherapist will also be involved
      in the management of pulmonary rehabilitation program to further make sure the high quality
      of pulmonary rehabilitation has been applied. Both arm participants will also receive in an
      open label fashion Indacaterol 150µg qd. for 6 months giving 2 therapy groups
      (Tai-Chi/Indacaterol, pulmonary rehabilitation/Indacaterol). The primary endpoint of this
      study is change in SGRQ between Tai-Chi/Indacaterol and pulmonary rehabilitation/Indacaterol
      at 14 weeks after entry and the secondary endpoints are change in FEV1% and six minute walk
      distance. the planned recruitment will be 120 with a view to obtaining 100 completers. The
      investigators propose the study starts on 31 Dec 2014 and completes on 30 June, 2016.
    


Intervention name(s): Tai-chi plus Indacaterol; Pulmonary rehabilitation plus Indacaterol
Intervention type(s): Other; Other
Intervention description(s): Participants perform Tai-chi exercise 5 days/week and take indacaterol 150ug/day for 24 weeks; Participants perform conventional exercise 5 days/week and take indacaterol 150ug/day for 24 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COPD; Pulmonary rehabilitation
Efficacy and Safety of Losartan in Children With Ig A Nephropathy
Condition: Glomerulonephritis, IGA
MeSH terms: Kidney Diseases; Glomerulonephritis; Glomerulonephritis, IGA
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigators hypothesize that using Losartan would help decrease proteinuria in
      controlling proteinuria in children with immunoglobulin A nephropathy.
    

Detailed description: 
      Twenty nine patient with IgA nephropathy with proteinuria (urine protein to creatinine ratio
      > 0.3 mg/mg) were included in the study. All patients had received losartan treatment for 24
      weeks. Changes in blood pressure, proteinuria, renal function, and biochemical parameters
      were prospectively evaluated before and at 4 weeks and 24 weeks.
    

Intervention name(s): Losartan
Intervention type(s): Drug
Intervention description(s): Dose of Losartan : 0.7mg/kg once daily.
Other intervention name(s): Cozaar
Intervention MeSH terms: Losartan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Losartan; Ig A nephropathy; children; proteinuria
Study of VI-0521 Compared to Placebo in Treatment of Obesity in Adults
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of two doses of VI-0521
      compared to placebo in treatment of obesity in an adult population with BMI ≥ 35.
    


Intervention name(s): VI-0521; VI-0521; Placebo matched phentermine/topiramate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 3.75 mg phentermine/23 mg topiramate; 15 mg phentermine/92 mg topiramate; Placebo matched phentermine/topiramate
Intervention MeSH terms: Topiramate; Phentermine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity, morbid obesity
Effects of Varying Duration of Naps on Cognitive Performance and Memory Encoding
Condition: Sleep
Study type: Interventional

Summary: 
      To evaluate the nap duration that achieves maximal cognitive gain with practicality of
      implementation, the present work employs a within-subject design comparing nap durations of
      10 minutes, 30 minutes, and 60 minutes with a no nap condition on benefits to alertness,
      vigilance, mood, speed of processing and memory over post-nap intervals of 5 minutes, 30
      minutes, 60 minutes and 240 minutes. The effect of nap duration on memory encoding will also
      be examined.
    

Detailed description: 
      Naps are a global phenomenon and a commonly adopted lifestyle countermeasure to reduce
      sleepiness and performance impairments. Experimental studies have also shown that naps can
      improve cognitive functioning and enhance memory and mood. However, the implementation of
      naps is highly varied amongst individuals, and it remains uncertain what duration of naps
      achieves the greatest cognitive benefit. Given the potential for naps to boost productivity
      in societies such as ours where insufficient nocturnal sleep is prevalent and where work
      hours are long, an investigation of the optimal nap duration is warranted.

      Previous studies suggest that the benefits of brief naps (5-15 minutes) occur immediately
      after the nap and last a limited period (1-3 hours). Longer naps (>30 minutes) are more
      likely to produce some temporary decrements due to sleep inertia but have the potential to
      improve cognitive performance for a more sustained period. These findings need to be
      strengthened through replication and extended to include memory measures that are evaluated
      over a longer post-nap testing period. To evaluate the nap duration that achieves maximal
      cognitive gain with practicality of implementation, the present work employs a within-subject
      design comparing nap durations of 10 minutes, 30 minutes, and 60 minutes with a no nap
      condition on benefits to alertness, vigilance, mood, speed of processing and memory over
      post-nap intervals of 5 minutes, 30 minutes, 60 minutes and 240 minutes. The effect of nap
      duration on memory encoding will also be examined.

      The investigator's findings are expected to inform theoretical models of sleep and cognition
      and will aid in the design of practical lifestyle strategies to alleviate sleepiness and
      improve cognitive performance that may be adopted in an everyday context to boost societal
      well-being and productivity.
    

Intervention name(s): Nap duration
Intervention type(s): Behavioral
Intervention description(s): A cognitive battery which will be repeated at 1505, 1530, 1600 and 1900. Material for the picture encoding task will be learned at 1630 and will be tested at 2000.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Deworming Against Tuberculosis
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional

Summary: 
      The purpose of this study is to investigate whether treatment against intestinal helminths in
      patients with pulmonary tuberculosis undergoing chemotherapy could improve the clinical
      outcome by enhancing host immunity.
    

Detailed description: 
      Mycobacterium tuberculosis causing tuberculosis (TB) is a major global public health problem.
      Because of increasing multi drug resistance and the long treatment period of at least six
      months, new therapeutic options are urgently needed. In countries like Ethiopia where TB is
      endemic, chronic worm infection is also highly prevalent. Recent data support that helminth
      infection might limit the host response against TB by inhibition of the TH1-response that is
      crucial in controlling the disease. In this study we want to test the hypothesis that
      Albendazole treatment of patients coinfected with helminths and TB could improve clinical
      outcome in addition to chemotherapy against TB. Additionally we will investigate the
      immunological interactions between TB and chronic helminths infection.
    

Intervention name(s): Albendazole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Albendazole 400mg per os for three consecutive days at week 2 and week 8 after initiation of chemotherapy against tuberculosis; Placebo 400mg per os for three consecutive days at week 2 and week 8 after initiation of chemotherapy against tuberculosis
Other intervention name(s): ALB
Intervention MeSH terms: Albendazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Deworming; Tuberculosis; TB-score; Albendazole; Helminths
Relative Bioavailability of HTL0018318 Oral Aqueous Solution Versus Capsules
Condition: Bioavailability and Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      HTL0018318 is a selective muscarinc M1 agonist. This study is a phase I, open label,
      randomised, crossover, single dose, trial in healthy volunteers to compare the relative
      bioavailability of HTL0018318 when given by oral aqueous solution and in capsule formulation.
    


Intervention name(s): HTL0018318
Intervention type(s): Drug
Intervention description(s): Two single doses of active drug (low, mid or high dose either as aqueous solution or capsule) separated by a washout of at least 12 days.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Skinlink With Suture for ED Patients
Condition: Wounds and Injuries; Lacerations
MeSH terms: Lacerations; Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether suture using the Device of "Leukosan
      Skinlink" is more faster and safer than that of "nylon" in the treatment of simple wound for
      ED patients.
    


Intervention name(s): Skinlink; Nylon
Intervention type(s): Other; Other
Intervention description(s): suture using Skinlink; conventional suture using nylon
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Anti-1-amino-3-[18F]Fluorocyclobutyl-1-carboxylic Acid (Anti-[18F](FACBC)Positron Emission Tomography (PET-CT) of the Breast
Condition: Breast Cancer
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Breast carcinoma is the most frequent cancer in women, affecting an estimated 207,090 in 2010
      leading to 39,840 cancer related deaths.

      Fludeoxyglucose F 18 Injection (FDG) Positron Emission Tomography, (PET) or PET-CT has become
      the a standard method for isolating the tumor. However, FDG is insensitive in small breast
      tumors and certain histologic types such as lobular, certain types of breast carcinoma. In
      addition, FDG uptake can be nonspecific since inflammatory some benign lesions may also
      evidence have accumulation of this radiotracer. Hence there is a need for a tracer/imaging
      tool that increases the ability to characterize detect breast carcinoma and to detect
      locoregional spread, as well as monitor therapeutic treatment response.

      anti-3-[18F]. anti-1-amino-3-[18F]fluorocyclobutyl-1-carboxylic acid (FACBC) is an amino acid
      based PET radiotracer which has shown utility in detecting a variety of tumors. In cell
      culture experiments,FACBC has shown uptake in the breast tumor cell line.

      The primary aim of this study is to determine if FACBC PET-CT demonstrates uptake within
      breast carcinoma (primary site and/or locoregional lymph nodes) and to study uptake kinetics
      via time-activity curves from dynamic imaging characteristics. The investigators will enroll
      12 patients who have a breast mass or masses and/or lymph nodes naïve to therapy about to
      undergo biopsy or post-biopsy pre-therapy. All patients will undergo standard of care imaging
      as appropriate such as mammography, ultrasound, MR, and/or FDG PET-CT scanning. The
      investigators will then compare findings to determine if this radiotracer is worthy of
      further study in a more comprehensive experiment.
    


Intervention name(s): FACBC
Intervention type(s): Drug
Intervention description(s): Drug FACBC will be given intravenously (IV) over 2 minutes prior to performing the PET scan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Yoga in School Sports - a Pilot Study in Germany
Condition: Yoga; Stress
Study type: Interventional

Summary: 
      The aim of this trial is a first evaluation of the effectiveness of yoga as alternative for
      school sports to evaluate potential effects in stress reduction and concomitant psychological
      parameters.
    


Intervention name(s): Yoga; School sport
Intervention type(s): Other; Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Yoga; Stress; Adolescents; School; Children
Main Branch Versus Side Branch Ostial Lesion
Condition: Coronary Artery Stenosis
MeSH terms: Coronary Stenosis
Study type: Observational

Summary: 
      The investigators studied the relations between coronary angiography (CAG), intravascular
      ultrasound (IVUS) and fractional flow reserve (FFR) in coronary ostial lesions.
    

Detailed description: 
      Angiographic evaluation for ostial lesions is reported to be inaccurate in the assessment of
      the functional and clinical significance of a lesion. The investigators studied the relations
      between coronary angiography (CAG), intravascular ultrasound (IVUS) and fractional flow
      reserve (FFR) in coronary ostial lesions.
    

Intervention name(s): Fractional flow reserve; IVUS
Intervention type(s): Device; Device
Intervention description(s): Fractional flow reserve measured by pressure wire; intravascular ultrasound
:IVUS was performed in a standard fashion using an automated motorized pullback system (0.5mm/s) with commercially available imaging catheter
Other intervention name(s): Radi Pressure Wire(Radi Medical Systems, Uppsala, Sweden); iLab® Ultrasound Imaging System(Boston Scientific/SCIMED, Minneapolis, MN, USA)
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        from september 2009 to january 2011 patient who are undergone coronary angiography,IVUS and
        FFR for the evaluation of coronary artery disease at SNUH
      
Keywords: FFR; IVUS; QCA