bioihbjkbjnl/mcl2 huggingface dataset:
Self-Expanding Nitinol Stent Versus Balloon Angioplasty Alone for the Below The Knee Arteries(SENS-BTK)
Condition: Critical Limb Ischemia; Infrapopliteal Arterial Occlusive Disease
MeSH terms: Chronic Limb-Threatening Ischemia; Arterial Occlusive Diseases; Ischemia
Study type: Interventional

Summary: 
      The objectives of this study are to compare directly conventional balloon angioplasty alone
      versus. balloon angioplasty with routine stenting - that is, to determine whether angioplasty
      with self-expanding stent is superior to conventional balloon angioplasty - in the
      infrapopliteal arterial occlusive lesions of critical limb ischemia patients by collecting
      and analyzing the cases of each patient group in a prospective multicenter randomized
      clinical trial, and to clarify main factors affecting mid- and long-term clinical effects of
      angioplasty with self-expanding stent in the infrapopliteal arteries.

      Hypothesis: Balloon PTA followed by routine stenting with self-expanding nitinol stent in
      critical limb ischemia patients with infrapopliteal arterial occlusive lesions is superior to
      conventional PTA in the aspect of vascular restenosis rate.
    


Intervention name(s): self-expanding nitinol stent; balloon angioplasty
Intervention type(s): Device; Device
Intervention description(s): A group of patients who will undergo subsequent primary stenting following successful conventional balloon angioplasty; A group of patients who will undergo routine conventional balloon angioplasty alone without stenting
Other intervention name(s): Xpert stent
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Provisional stenting with SMART(n=173), Provisional stenting with Complete SE(n=173)
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence Study of Isotretinoin Capsules 40 mg Under Fed Condition
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the pharmacokinetics and bioequivalence of
      isotretinoin formulations after administration of single doses to normal, non-smoking,healthy
      males under fed conditions
    

Detailed description: 
      An open label, randomized, two-treatment, single dose, oral bioequivalence study of
      Isotretinoin capsules 40 mg of Dr. Reddy's Laboratories Limited,under fed conditions
    

Intervention name(s): Isotretinoin
Intervention type(s): Drug
Intervention description(s): Isotretinoin Capsules,40 mg
Other intervention name(s): ACCUTANE
Intervention MeSH terms: Isotretinoin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of LY2140023 in Hepatically-Impaired Participants
Condition: Hepatic Insufficiency
MeSH terms: Hepatic Insufficiency; Liver Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will explore how liver impairment affects blood levels of LY2140023 (a prodrug)
      and its active metabolite (LY404039).
    

Detailed description: 
      The study included 4 groups, based on the Child-Pugh classification of hepatic impairment as
      follows:

      Group 1: Participants with normal hepatic function (Control); Group 2: Participants with mild
      hepatic impairment (Child-Pugh class A); Group 3: Participants with moderate hepatic
      impairment (Child-Pugh class B); and Group 4: Participants with severe hepatic impairment
      (Child-Pugh class C).
    

Intervention name(s): LY2140023
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Neobladder Posterior Wall Suspended With Round Ligament of Uterus
Condition: Female; Bladder Cancer; Radical Cystectomy; Neobladder; Posterior Wall Suspended With Round Ligament of Uterus
MeSH terms: Urinary Bladder Neoplasms
Study type: Interventional

Summary: 
      Objective: to evaluate if the Neobladder posterior wall suspended with round ligament of
      uterus could improve neobladder empty after radical cystectomy in female patients with
      bladder cancer compared to present standard neobladder
    

Detailed description: 
      The investigators developed a technical modification which to aim to provide an posterior
      support to the ideal neobladder and obtain the anatomy recovered neobladder by posterior wall
      of neobladder suspended with round ligament. In this study the investigators designed the
      prospective random trial to evaluate whether this technique improves the neobladder empty
      compared to a current standard neobladder reconstruction.
    

Intervention name(s): rONB
Intervention type(s): Procedure
Intervention description(s): Neobladder posterior wall suspended with round ligament of uterus after radical cystectomy in female with bladder cancer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Mix Vaccine for Metastatic Colorectal Cancer
Condition: Metastatic Colorectal Cancer; Reaction - Mixed Vaccine
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this study is the safety and efficacy of mix vaccine to small metastases of
      colorectal cancer.
    

Detailed description: 
      By enrolling patients with small metastases of colorectal cancer adapted to enrolled
      criteria, this study will document for the first time the safety and the short and long term
      efficacy of mix vaccine.

      The safety will be evaluated by statistics of adverse reactions. The efficacy will be
      evaluated according to local relief degree, progress free survival (PFS) and overall survival
      (OS).
    

Intervention name(s): Mix vaccine
Intervention type(s): Biological
Intervention description(s): Each treatment: 0.5 ml /week, Subcutaneous injection of the deltoid muscle
Other intervention name(s): Active immunotherapy for cancer
Intervention MeSH terms: Immunomodulating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Comparison of Seroquel vs. Risperidone in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to show equal efficacy of both quetiapine and risperidone in
      subjects treated with study medication for up to 8 weeks.
    


Intervention name(s): quetiapine fumarate vs risperidone
Intervention type(s): Drug
Intervention MeSH terms: Risperidone; Quetiapine Fumarate
Primary purpose: Treatment
The Effect of Sound Stimulation on Pure-tone Hearing Threshold
Condition: Sensorineural Hearing Loss
MeSH terms: Hearing Loss; Hearing Loss, Sensorineural
Study type: Interventional

Summary: 
      The purpose of this study is to investigate if sound stimulation could improve pure-tone
      hearing threshold.

      In the late 1990s, researchers discovered that acoustic stimuli slow progressive
      sensorineural hearing loss and exposure to a moderately augmented acoustic environment can
      delay the loss of auditory function. In addition, prolonged exposure to an augmented acoustic
      environment could improve age-related auditory changes. These ameliorative effects were shown
      in several types of mouse strains, as long as the acoustic environment was provided prior to
      the occurrence of severe hearing loss.

      In addition to delaying progressive hearing loss, acoustic stimuli could also protect hearing
      ability against damage by traumatic noise. In particular, a method called forward sound
      conditioning (i.e., prior exposure to moderate levels of sound) has been shown to reduce
      noise-induced hearing impairment in a number of mammalian species, including humans.

      Interestingly, recent report has suggested that low-level sound conditioning also reduces
      free radical-induced damage to hair cells, increases antioxidant enzyme activity, and reduces
      Cox-2 expression in cochlea, and can enhance cochlear sensitivity. Specifically, increased
      cochlear sensitivity was observed when distortion product otoacoustic emissions (DPOAEs) and
      compound action potentials (CAPs) were measured.

      In addition to forward sound conditioning, backward sound conditioning (i.e., the use of
      acoustic stimuli after exposure to a traumatic noise) has been shown to protect hearing
      ability against acoustic trauma and to prevent the cortical map reorganization induced by
      traumatic noise.

      Based on the results of animal studies, the investigators conducted a human study in 2007 and
      observed that sound stimulation could improve hearing ability. On average, the pure-tone
      hearing threshold decreased by 8.91 dB after sound stimulation for 2 weeks. In that study,
      however, the investigators observed only the hearing threshold changes by sound stimulation.

      To verify the previous ameliorative effect of sound stimulation, the investigators included a
      control period in this study.
    


Intervention name(s): Sound stimulation
Intervention type(s): Behavioral
Intervention description(s): Listening to sound stimuli at the lowest audible level.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Examining the Attitudes of Physiotherapists on Patient Psychology
Condition: Psychology, Social; Psychological
Study type: Observational

Summary: 
      To examine the psychology methods used by physiotherapists on patient psychology and to
      investigate their attitudes about psychology education.
    

Detailed description: 
      The answers will be collected by asking questions to the participants with an online survey.
      The scales and surveys to be used are as follows:

        -  Working Alliance Inventory (Therapeutic Alliance Scale)

        -  Attitude Towards Psychiatry-30 Scale

        -  Questionnaires prepared by the researcher.

      surveys will be sent to the participants via e-mail or phone message applications.The
      obtained data will be analyzed statistically.
    

Intervention name(s): Survey
Intervention type(s): Other
Intervention description(s): Working Alliance Inventory
Attitude Towards Psychiatry-30 Scale
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        active physiotherapists
      
Keywords: physiotherapist; attitude
An End to the Yom Kippur (and Ramadan) Headache
Condition: Headache
MeSH terms: Headache
Study type: Interventional

Summary: 
      Fasting is a known trigger for headache. People who fast to comply with religious edict have
      been shown to be prone to headache which becomes more likely to occur with increasing length
      of fasting, and in people prone to headache. This has been documented as 'Yom Kippur
      Headache' and 'First of Ramadan Headache.' We performed a study to test the hypothesis that
      Rofecoxib, a pain medicine and anti-inflammatory, with a prolonged duration of action would
      prevent or attenuate headache when taken just prior to the complete (no food or drink) 25
      hour fast of Yom Kippur.
    

Detailed description: 
      Introduction: Religious fasting is associated with headache. This has been documented as 'Yom
      Kippur Headache' and ' First- of - Ramadan Headache.' The Cox2 inhibitor, rofecoxib, has been
      reported effective in preventing perimenstrual migraine and in preventing recurrence of
      migraine. Given its 17 hour half-life, we undertook this study to see whether 50mg rofecoxib
      taken just prior to the 25 hour Yom Kippur fast would be effective in preventing headache.

      Methods: We performed a double blind randomized prospective trial of rofecoxib 50mg vs
      placebo, taken just prior to the onset of fasting, Yom Kippur 2004. Healthy adults aged 18 -
      65 were enrolled from the community and from hospital staff. Subjects completed a demographic
      data form and questions regarding headache history and a post-fast survey on headache during
      the fast, headache intensity, general ease of fasting and side effects.

      Results: We sent out 170 forms of which 105 were completed and returned. Of those subjects
      receiving rofecoxib (n=53), ten or 18.9% vs 34 or 65.4 % of the placebo group (n=52) had
      headache at some point during the fast (p<.0001). Severity of headache in the treatment group
      was significantly less for the treatment group (3.45 vs 6.29 on a visual analog scale of 10
      (p = .009)). None of those receiving rofecoxib reported a 'more difficult than usual fast'
      whereas the distribution of difficult to easy fast among the placebo group was more even.

      Conclusion: Rofecoxib 50mg taken prior to a twenty five hour ritual fast prevents and
      attenuates fasting headache.
    

Intervention name(s): Rofecoxib
Intervention type(s): Drug
Intervention MeSH terms: Rofecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Fasting; Headache; Cox 2 Inhibitors; Pain; Prophylaxis
Extended Infant Post-exposure Prophylaxis With Antiretrovirals to Reduce Postnatal HIV Transmission
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if extended antiretroviral regimens given to the
      infant during the first 14 weeks of age would decrease breast milk transmission of HIV.
    

Detailed description: 
      This is a three-arm randomized, open label, clinical trial to evaluate the effectiveness of
      two extended regimens of antiretrovirals compared to infant single dose nevirapine plus AZT
      given twice daily for 1 week (comparison regimen). All infants receive the comparison regimen
      at birth and then randomized at birth to start either one of the two extended regimens after
      the first week. The extended regimens are nevirapine daily and nevirapine plus AZT daily -
      both regimens are given up to age 14 weeks.
    

Intervention name(s): Nevirapine; AZT; NVP and AZT; NVP; NVP+AZT
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Oral NVP daily dosage; Oral AZT daily; Oral single dose NVP plus oral daily AZT during the first weeks; Oral NVP daily to age 14 weeks; Oral NVP daily plus oral AZT daly to age 14 weeks
Other intervention name(s): Zidovuidne (ZDV); Nevirapine and zidovudine; Nevirapine; Nevirapine plus zidovudine
Intervention MeSH terms: Zidovudine; Nevirapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV; MTCT; Infants; africa; HIV Seronegativity
A 52-Week Placebo-Controlled Study Evaluating the Safety of Varenicline
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this study is to obtain safety information on cigarette smokers
      treated with 52 weeks of varenicline regardless of smoking status.
    


Intervention name(s): varenicline (CP-526,555)
Intervention type(s): Drug
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Study to Evaluate the Erythropoietic Response in Hepatitis C Virus (HCV) Patients Receiving Combination Ribavirin (RBV)/Interferon (IFN) Therapy or RBV/PEG IFN (NATURAL HISTORY-HCV)
Condition: Hepatitis C; Anemia
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to describe the time course and extent of hemoglobin (Hb)
      changes and the erythropoietic response to PEG-IFN/RBV-induced anemia In HCV-infected
      subjects.
    

Detailed description: 
      Patients receiving combination therapy for chronic hepatitis C virus (HCV) infection
      (standard or pegylated interferon alfa [PEG-IFN] in combination with ribavirin [RBV])
      frequently develop moderate to severe anemia. In large, prospective, clinical trials of
      PEG-IFN alfa-2b and PEG-IFN alfa-2a, the reported mean decreases in hemoglobin (Hb) were 2.5
      g/dL and 3.7 g/dL, respectively. Furthermore, in a retrospective study, 54% of standard
      interferon/RBV-treated patients had hemoglobin (Hb) decreases of at least 3 g/dL. It is
      important to understand the causes, natural history, and risk factors associated with HCV
      therapy-induced anemia, because such decreases in Hb can result in RBV dose reduction or
      discontinuation, which may adversely affect the likelihood of a virologic response.
      Erythropoietin is an endogenous hormone that acts in the bone marrow to increase the number
      of erythroid progenitor cells. Normally, a decrease in the Hb level is accompanied by an
      increase in the serum erythropoietin (sEPO) level, which will ultimately normalize the Hb
      level. The relationship between Hb and sEPO is less apparent in patients with chronic
      diseases such as cancer and human immunodeficiency virus (HIV) infection. It is not known
      whether HCV-infected patients receiving combination PEG-IFN/RBV therapy have a similarly
      diminished erythropoietic response to anemia.

      One hundred HCV-infected patients who are receiving combination RBV/IFN or RBV/PEG-IFN
      therapy will be enrolled in this multicenter study. No study medication will be administered
      during this study. Weekly blood samples will be collected at specified times during the
      initial 8 weeks of RBV/IFN or RBV/PEG-IFN therapy. Assessment of laboratory tests, vital
      signs, incidence and severity of adverse experiences will be obtained.

      The objective of this study is to document the pattern of hemoglobin changes and
      erythropoietic response (from baseline to final assessment, up to Week 8) in HCV-infected
      patients receiving combination therapy with RBV/IFN or RBV/PEG-IFN. N/A
    

Intervention name(s): Pegylated Interferon and Ribavirin
Intervention type(s): Drug
Intervention MeSH terms: Interferons; Ribavirin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Natural History,; Hepatitis C Infection; Ribavirin; Pegylated Interferon; Interferon
Pilot Study of the Comparison of the Upper Airway Dynamics of Oronasal vs Nasal Masks With PAP Treatment
Condition: Obstructive Sleep Apnea (OSA)
MeSH terms: Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Our group has recently found that the choice of positive airway pressure mask can
      significantly affect the pressure required to adequately treat sleep disordered breathing.
      The goal of this study is to visualize the upper airway in the retropalatal and retroglossal
      region while using both oronasal and nasal masks with CPAP in order to investigate
      differences in upper airway dynamics that may occur between these two mask types.
    

Detailed description: 
      It is known that oronasal masks are not as effective at opening the upper airway compared to
      nasal only continuous positive airway pressure (CPAP) masks in patients with sleep-disordered
      breathing. However, the physiological mechanism for this difference in efficacy is not known;
      although, it has been hypothesized to involve the retroglossal and/or retropalatal region of
      the upper airway. The objective of this study was to investigate differences in retroglossal
      and retropalatal anterior-posterior space with the use of oronasal vs. nasal CPAP masks using
      real-time cine magnetic resonance imaging (cMRI).
    

Intervention name(s): Nasal and Oronasal PAP Mask
Intervention type(s): Device
Intervention description(s): Subjects will be imaged via MRI wearing a nasal and oronasal PAP mask at 5, 10 and 15 cm H20.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
A Study of GSK1325760A in Healthy Japanese Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the safety, tolerability, pharmacokinetics and the effect of food on
      pharmacokinetics after single oral administrations of GSK1325760A
    

Detailed description: 
      Phase1 study of GSK1325760A

      - A double blind, single center, randomised, placebo-controlled, partially crossover, single
      dose study to investigate the safety, tolerability, pharmacokinetics and to assess the effect
      of food on pharmacokinetics of ascending oral doses of GSK1325760A in healthy Japanese male
      subject -
    

Intervention name(s): GSK1325760A
Intervention type(s): Drug
Intervention MeSH terms: Ambrisentan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: safety; Pharmacokinetics; effect of food on pharmacokinetics
Flublok v. Standard Dose Vaccine Effectiveness Among Kaiser Permanente Northern California Adults 18-64 Years
Condition: Influenza; Pneumonia; Lower Respiratory Tract Infection; Acute Myocardial Infarction; Congestive Heart Failure; Stroke
MeSH terms: Influenza, Human; Respiratory Tract Infections; Heart Failure; Myocardial Infarction; Infarction
Study type: Observational

Summary: 
      The overall objective of this study is to describe the effectiveness of Flublok Quadrivalent
      vaccine compared to standard dose inactivated influenza vaccine (SD-IIV) in adults 18 through
      64 years of age. During this study, Flublok Quadrivalent or SD-IIV will be administered
      according to the guidelines in the Prescribing Information materials and only to persons for
      whom it is indicated. The 2018-2019, 2019-2020, and 2020-2021 formulations of recombinant
      influenza vaccine (Flublok Quadrivalent vaccine) and SD-IIV will be evaluated for outcomes
      including all polymerase chain reaction (PCR)-confirmed influenza, PCR-confirmed hospitalized
      influenza, hospitalized community-acquired pneumonia and cardio-respiratory events.
    


Intervention name(s): Flublok Quadrivalent; Standard Dose Inactivated Influenza Vaccine (SD-IIV)
Intervention type(s): Biological; Biological
Intervention description(s): Flublok Quadrivalent vaccine is a recombinant hemagglutinin influenza vaccine indicated for active immunization against disease caused by influenza A subtype viruses and type B viruses contained in the vaccine for adults 18 years of age and older. Use of recombinant DNA techniques to produce vaccine antigen expressed in cell culture is a method that avoids growing the influenza viruses in embryonated hen's eggs.; For the 2018-2019, 2019-2020, and 2020-2021 flu seasons, the primary SD-IIVs used will be Fluarix Quadrivalent and Flulaval Quadrivalent.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Eligible adults aged 18-64 years will receive either Flublok Quadrivalent vaccine or a
        standard dose inactivated influenza vaccine in the course of routine influenza vaccination
        during each of the two influenza seasons of the study period at Kaiser Permanente Northern
        California.
      
Keywords: influenza; vaccine effectiveness