bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Efficacy and Safety of Quadruple Therapy (VX-222, Telaprevir,Peginterferon-Alfa-2a, Ribavirin) in Subjects With Chronic Hepatitis C With Compensated Cirrhosis
Condition: Chronic Hepatitis C Virus
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of a quadruple regimen
      (VX-222, telaprevir, pegylated interferon, and ribavirin)in subjects with hepatitis C with
      cirrhosis.
    


Intervention name(s): VX-222; telaprevir; ribavirin; peginterferon-alfa-2a
Intervention type(s): Drug; Drug; Drug; Biological
Intervention description(s): tablet, 400-mg twice daily; tablet, 1125-mg twice daily; tablet, 1000-mg per day for subjects weighing <75 kg and 1200 mg per day for subjects weighing ≥75 kg, twice daily; subcutaneous injection, 180-mcg, once weekly
Other intervention name(s): Incivek, VX-950, Incivo; Copegus; Pegasys
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Acute Myocardial Infarction by Penetrating Cardiac Trauma
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Observational

Summary: 
      Patients with a cardiac stab wound could be complicated by a posttraumatic acute myocardial
      infarction (PAMI). Traditionally, the investigators can explain it by the occlusion of a
      coronary artery; but the PAMI isn´t constantly related with coronary artery injuries or their
      damage in the cardiac injury repair. The investigators objectives are to know the PAMI
      incidence, make an approximation to PAMI pathophysiology, and propose management strategies.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study included patients admitted to the emergency department of the San Vicente de Paul
        University Hospital with a penetrating stab cardiac injury without previous injuries
      
Keywords: Heart injuries; Posttraumatic myocardial infarction; Echocardiography; Coronary angiography
Levocetirizine Effect on Nasal Nitric Oxide and Nasal Eosinophils in Subjects With Perennial Allergic Rhinitis
Condition: Perennial Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to noninvasively measure the anti-inflammatory effect of
      levocetirizine after two weeks of treatment in allergic rhinitis subjects.
    


Intervention name(s): levocetirizine (Xyzal); placebo
Intervention type(s): Drug; Drug
Intervention description(s): 5mg po QD; sugar tablet
Other intervention name(s): Xyzal
Intervention MeSH terms: Levocetirizine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Luteal Phase Administration of Paroxetine for the Treatment of PMDD
Condition: Premenstrual Dysphoric Disorder
MeSH terms: Premenstrual Dysphoric Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The efficacy of SSRI use to relieve the symptoms associated with premenstrual dysphoric
      disorder has been established. We proposed to test the hypothesis that intermittent treatment
      with paroxetine administered during the luteal phase of the menstrual cycle only is more
      effective than placebo in improving symptoms of PMDD. This was a double-blind,
      placebo-controlled, three-arm parallel group study of patients with PMDD. Menstruating women
      18 years of age or older who met criteria for inclusion in the study were randomized to one
      of three arms: paroxetine 10mg/day during the luteal phase of the menstrual cycle; paroxetine
      20mg/day during the luteal phase of the menstrual cycle; placebo daily during the luteal
      phase of the menstrual cycle. The objective was to evaluate the efficacy and safety of
      intermittent treatment of paroxetine in women with PMDD.
    


Intervention name(s): Paroxetine
Intervention type(s): Drug
Intervention description(s): Paroxetine 10mg and 20mg during the luteal phase of the menstrual cycle
Intervention MeSH terms: Paroxetine
Effect of Prone Positioning in Patients With COVID-19
Condition: Covid19
MeSH terms: COVID-19
Study type: Observational

Summary: 
      COVID-19 is affecting the people around the world and the infected individuals' may either
      stay asymptomatic or present to hospitals with severe distress and life threatening symptoms.
      The objective of the study is to investigate role of Prone positioning and alternate nostril
      breathing in patients with Covid-19.
    

Detailed description: 
      In this prospective study, 30 patients aged 40-80 years of either gender with a confirmed
      diagnosis of COVID-19 receiving supplemental oxygen were recruited from DHQ Hospital
      Faisalabad. patients were grouped into two A & B. We collected baseline data on demographics
      and anthropometrics. After baseline data collection, all the patients were helped into the
      prone position, which was maintained for a minimum duration of three hours. After that
      patients in group B performed alternate nostril breathing for 10 minutes with help of
      therapist. Clinical data were re-collected on 3rd day of intervention one hour after
      returning to the supine position in group A and after alternate nostril breathing in group B.
      The main study outcome was the variation in oxygenation (partial pressure of oxygen [PaO2]/
      fractional concentration of oxygen in inspired air [FiO2]) between baseline and resupination,
      and General psychological state through GAD-7 General anxiety disorder questionnaire.
    

Intervention name(s): Prone Lying Position; alternate nostril breathing
Intervention type(s): Other; Other
Intervention description(s): patient lies on his/ her stomach facing floor.; patient inspires with one nostril at a time, right or left one by one and expires by mouth.
Other intervention name(s): Positioning; breathing technique
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        known cases of Covid-19 who were hospitalized.
      
Keywords: Covid-19; General Anxiety Disorder-7; Prone Position; Alternate Nostril Breathing
A Pharmacokinetic Study of Dapivirine Vaginal Rings in Belgium
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      IPM 018 is a double-blind, randomized, placebo-controlled study conducted at one site in
      Belgium among 24 healthy, HIV-negative women to evaluate dapivirine release for 28 days from
      matrix and reservoir intravaginal rings, each containing 25 mg of dapivirine, and to assess
      safety and tolerability compared to placebo
    


Intervention name(s): dapivirine reservoir intravaginal ring; dapivirine matrix intravaginal ring; placebo intravaginal ring
Intervention type(s): Drug; Drug; Other
Intervention description(s): a silicone elastomer reservoir ring containing 25mg of dapivirine; a silicone elastomer matrix intravaginal ring containing 25mg of dapivirine; a silicone elastomer intravaginal ring containing no dapivirine
Intervention MeSH terms: Dapivirine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: HIV-1 infection; HIV Seronegativity
Improving Cognition in Schizophrenia Using Non-invasive Brain Stimulation
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      This is a double-blind sham-controlled study to evaluate the effects of the combination of
      non-invasive brain stimulation, i.e. transcranial direct current stimulation (tDCS), with
      brief cognitive training (CT) on cognition in patients with schizophrenia. All participants
      will practice the same cognitive training tasks and will be randomised to either real tDCS or
      sham stimulation. Patients with schizophrenia will undergo the study interventions while
      maintaining their standard treatment with antipsychotic medications.
    


Intervention name(s): non-invasive brain stimulation
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Effect of Denosumab on Cellular Biomarkers in the Human Breast
Condition: Healthy Volunteer, Female, Breast
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate whether administration of denosumab results in a decrease compared to the control
      group in proliferation of mammary epithelial cells as measured by the Ki-67 proliferation
      index.
    


Intervention name(s): Denosumab; Percutaneous core needle breast biopsy
Intervention type(s): Drug; Procedure
Intervention description(s): Single sucutaneous dose
Intervention MeSH terms: Denosumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Neubotulinum Toxin Injection in Cerivical Dystonia
Condition: Cervical Dystonia
MeSH terms: Dystonia; Dystonic Disorders; Torticollis
Study type: Interventional
Phase: Phase 3

Summary: 
      24-Week Prospective, Double-Blinded, Randomized, Cross-over design in Multicenter Study of 50
      unit of Neubotulinum Toxin Type A (Neuronox) and 100 unit of Neubotulinum Toxin Type A
      (Neuronox) injection for Cervical Dystonia in patient diagnosed with cervical dystonia
      according to clinical diagnosis. It was designed to evaluate the efficacy, safety,
      tolerability, quality of life and the comparesion the improvement after treatment by of 50
      unit of Neubotulinum Toxin Type A (Neuronox) and 100 unit of Neubotulinum Toxin Type A
      (Neuronox) injection.
    

Detailed description: 
      Three documented studies showed the clinical use of botulinum toxin for migraine
      prophylaxis.(26) Neubotulinum Toxin Type A, (Neu-BoNT/A), (Neuronox® ) (Medytox Inc,
      Ochang-eup, Cheongwon-gu, Cheongju-si, Chungcheongbuk-do, Republic of Korea), also known as
      Meditoxin in Korea, is a newly manufactured BoNT-A (Neu-BoNT/A) that was developed to provide
      features close to onabotulinum toxin A (5). Neuronox was tested in a murine model, and its
      effect on muscle force generation was equivalent to Botox® (ona-BoNT/A) (6). A previous
      multicenter randomized controlled trial showed that Neuronox and Botox® have equivalent
      efficacy and safety for the treatment of spastic equinus in children with cerebral palsy (6).
      However, 50 unit of Neubotulinum Toxin Type A (Neuronox) and 100 unit of Neubotulinum Toxin
      Type A (Neuronox) has not yet been investigated in cervical dystonia. This study is the
      extension of the NCT03805152
    

Intervention name(s): Neuronox ® Injection
Intervention type(s): Drug
Intervention description(s): Neuronox ® 50 or 100 unit intramuscular injection
Other intervention name(s): Neuronox ® 50 unit or 100 unit
Intervention MeSH terms: Botulinum Toxins, Type A
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover Assignment Double Blind randomized controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate the Effectiveness and Safety of Epoetin Alfa During the Period When One is Donating One's Own Blood Before Surgery.
Condition: Anemia
MeSH terms: Anemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the whether epoetin alfa stimulates the bone marrow
      to produce red blood cells and therefore increases a patient's ability to self-donate blood
      prior to major surgery. Epoetin alfa is a genetically engineered protein that stimulates red
      blood cell production.
    

Detailed description: 
      Major surgical procedures may require several units of blood. Blood transfusions from other
      people may be associated with transfusion reactions that cause fever or uncommonly,
      blood-borne infections. However, self-blood collections may cause anemia in a patient who
      will be undergoing surgery a few weeks later. Previous research with epoetin alfa suggests
      that it increases the rate of red blood cell production and has a beneficial effect on
      anemia. This randomized, double-blind, placebo-controlled 21-day study is designed to
      determine whether intravenous epoetin alfa will stimulate a patient's bone marrow to produce
      red blood cells and therefore increase a patient's ability to self-donate blood prior to
      major surgery for joint disease. Patients will be randomly assigned to receive either epoetin
      alfa 600 units per kilogram of body weight or a matching volume of placebo injected into a
      vein on the first study day and every 3 to 4 days thereafter for 21 days, for a total of 6
      doses. The primary measures of effectiveness will be determined by the number of units of
      blood that can be obtained from patients during the study, the change in hemoglobin and
      hematocrit from pre-study to post-study, and the number of transfusions required around the
      time of surgery. Safety will be evaluated based on laboratory tests, vital signs, and the
      incidence and severity of any adverse or unusual experiences associated with drug
      administration. The study hypothesis is that patients treated with epoetin alfa will be able
      to donate more units of blood for their own surgery while receiving epoetin alfa than
      patients receiving placebo. Epoetin alfa 600 units per kilogram or an equal volume of placebo
      injected into a vein on the first day of the study, and every 3 to 4 days thereafter until
      day 21, for a total of 6 doses.
    

Intervention name(s): epoetin alfa
Intervention type(s): Drug
Intervention MeSH terms: Epoetin Alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Anemia; blood transfusion; epoetin alfa; erythropoietin; surgery; self-blood donation
Risperidone Treatment in Dually-Diagnosed Individuals - 2
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of risperidone for cocaine
      dependence in individuals with schizophrenia/schizoaffective illness.
    


Intervention name(s): Risperidone
Intervention type(s): Drug
Intervention MeSH terms: Risperidone
Primary purpose: Treatment
Keywords: cocaine dependence
Non-intrusive Detection of Temporary Neurologic Impairment By Opioids
Condition: Healthy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Research is being conducted to better understand the physiologic effects (relating to the
      action of a drug when taken by a healthy person) of opioid use on oculomotor (relating to the
      motion of the eye) dynamics and to identify the presence of characteristics consistent with a
      specific drug or class of drugs.
    


Intervention name(s): Oxycodone; Placebo; EyeLink 1000 Plus; Oculo-Cognitive Addition test (OCAT); VT3mini - Eye Tracking Technology for OEMs
Intervention type(s): Drug; Drug; Device; Diagnostic Test; Device
Intervention description(s): 5 mg tablet; Oxycodone-matched placebo tablet; Non-invasive video-based eye tracking system; Subject will have to look for numbers on a screen and add these numbers together. OCAT will be presented on a computer screen with attached eye tracking device at the bottom part.; Non-invasive eye-tracking device
Other intervention name(s): Oxycodone Immediate Release; EyeLink; EyeTech
Intervention MeSH terms: Oxycodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Safety, Tolerability and Efficacy of ACTIMMUNE® Dose Escalation in Friedreich's Ataxia Study
Condition: Friedreich's Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia; Friedreich Ataxia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this phase 3 multi-center, open-label extension study is to evaluate the
      long-term safety of ACTIMMUNE® (interferon-γ 1b) in participants with Friedreich's Ataxia.
    

Detailed description: 
      Participants who complete 26 weeks of blinded treatment in HZNP-ACT-301 (NCT02415127), will
      be eligible to enter this 6-month study. All participants will receive ACTIMMUNE® 3 times a
      week (TIW) for 26 weeks. In order to maintain the study blind in HZNP-ACT-301 (NCT02415127),
      all participants in this open-label extension study will undergo ACTIMMUNE® titration,
      regardless if they received ACTIMMUNE® or placebo in HZNP-ACT-301 (NCT02415127). The Week 26
      Visit from HZNP-ACT-301 (NCT02415127) will serve as the Baseline Visit (Day 1) for this
      study. During the treatment period, additional clinic visits are scheduled at Weeks 4, 13,
      and 26; in between clinic visits, participants (and/or caregivers) will be monitored via
      emails/phone calls on a weekly basis until participants reach their maximum tolerated dose,
      and on a monthly basis thereafter.
    

Intervention name(s): Interferon γ-1b
Intervention type(s): Drug
Intervention description(s): The study drug dose is planned to be escalated on a weekly basis over the first 4 weeks of treatment (from 10 µg/m² to 25, 50, and 100 µg/m²). The dose may be reduced, interrupted, or held based on tolerability. By Week 13, all participants are to be on a stable tolerated dose of study drug in order to continue study participation; the dose may not be further increased after Week 13, however, it may be reduced on a case-by-case basis to manage drug-related adverse events (AEs).
Other intervention name(s): ACTIMMUNE®
Intervention MeSH terms: Interferons; Interferon-gamma
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Interferon gamma
Dose-Response, Safety and Efficacy of Febuxostat in Subjects With Gout
Condition: Gout
MeSH terms: Gout
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the efficacy of febuxostat, once daily (QD), in
      reducing serum urate levels in subjects with gout.
    

Detailed description: 
      Gout is a chronic urate crystal deposition disorder, which if left untreated may result in
      progressive disease characterized by joint and bone destruction from tophaceous deposits and
      renal impairment due to gouty nephropathy. Hyperuricemia, defined as a serum urate
      concentration of >7.0 milligrams per deciliter (mg/dL), is the underlying metabolic
      aberration leading to urate crystal deposition in gout. Gout has several clinical
      presentations, including: recurrent acute attacks of inflammatory arthritis; deposition of
      monosodium urate monohydrate crystals in joints, bones and even parenchymal organs
      (tophaceous gout); renal impairment; and uric acid nephrolithiasis. As serum urate levels
      increase beyond >7.0 mg/dL, the risks for gouty arthritis or for renal calculi increase.

      Currently allopurinol is the only xanthine oxidase inhibitor available. Allopurinol is the
      agent of choice for reduction of serum urate levels in patients with: uric acid
      overproduction; unresponsive or intolerant to uricosuric agents; impaired renal function;
      uric acid urolithiasis; or tophi.

      Febuxostat (TMX-67) is a non-purine selective xanthine oxidase inhibitor being developed as
      an orally administered agent for management of hyperuricemia in patients with gout.
    

Intervention name(s): Placebo; Febuxostat; Febuxostat; Febuxostat
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Febuxostat placebo-matching tablets, orally, once daily for up to 4 weeks.; Febuxostat 40 mg, tablets, orally, once daily for up to 4 weeks.; Febuxostat 80 mg, tablets, orally, once daily for up to 4 weeks.; Febuxostat 120 mg, tablets, orally, once daily for up to 4 weeks.
Other intervention name(s): TMX-67; Tei-6720; Uloric; TMX-67; Tei-6720; Uloric; TMX-67; Tei-6720; Uloric
Intervention MeSH terms: Febuxostat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Uric Acid; xanthine oxidase; tophi; Drug Therapy
Opioid Versus Non-opioid Anesthesia for Ambulatory Surgery in Children
Condition: Effect of Anesthesia in Postoperative Pain; Effect of Anesthesia in Extubation Time; Effect of Anesthesia in Discharge Time From Postanesthesia Care Unit; Effect of Anesthesia in Postoperative Adverse Events; Effect of Anesthesia in Discharge Time From the Hospital
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators intend to study the safety and effectiveness of opioid free anesthesia
      compared to opioid anesthesia in ambulatory surgery in children, regarding postoperative
      pain, hemodynamic stability, agitation and discharge times. Quality of postanesthetic care
      was estimated in a 24h follow up.
    


Intervention name(s): Ketamine, dexmedetomidine; fentanyl, remifentanil
Intervention type(s): Drug; Drug
Intervention description(s): Patients will receive non-opioid analgesics, such as dexmedetomidine, ketamine perioperatively; Patients will receive opioid analgesics, such as fentanyl and remifentanil perioperatively
Intervention MeSH terms: Fentanyl; Dexmedetomidine; Ketamine; Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Other
Azithromycin Combination Therapy for the Treatment of Uncomplicated Falciparum Malaria in Bangladesh
Condition: Uncomplicated Falciparum Malaria
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the efficacy of azithromycin combination therapy
      with artesunate for the treatment of uncomplicated falciparum malaria in Bangladesh.
    

Detailed description: 
      In view of spreading antimalarial drug resistance there is an urgent need for new combination
      treatments for a disease that kills more than one million people every year. Azithromycin is
      a macrolide antibiotic that is particularly attractive due to its safety in children and
      experience with use in pregnancy. Recent trials suggest that azithromycin has a strong
      potential as an antimalarial. The purpose of this study is to investigate the efficacy of
      azithromycin combination therapy for the treatment of uncomplicated falciparum malaria in
      Bangladesh.
    

Intervention name(s): azithromycin plus artesunate; Artesunate
Intervention type(s): Drug; Drug
Intervention MeSH terms: Azithromycin; Artesunate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: falciparum malaria; therapy; azithromycin; artesunate; Coartem; Bangladesh