bioihbjkbjnl/mcl2 huggingface dataset:
A Phase I Study of Safety & Immunogenicity of AERAS-456 in HIV-Neg. Adults Treated for Drug-susceptible Pulmonary TB
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, double-blind, randomized, placebo-controlled safety and immunogenicity
      study in adults who have recently been successfully treated for drug-susceptible pulmonary
      Tuberculosis (TB). The safety and immunogenicity profile of escalating doses of AERAS-456 in
      HIV-negative subjects recently treated for drug-susceptible pulmonary TB will be
      investigated. The study will be conducted at three sites in South Africa.
    

Detailed description: 
      This study will be the first evaluation of AERAS-456 in subjects who have completed a full
      course of treatment prescribed for pulmonary TB. Subjects will begin screening for study
      participation when they have completed 4 calendar months of TB treatment. Subjects meeting
      the inclusion/exclusion criteria will be randomized within a study group in a 3:1 ratio (N=18
      AERAS-456; N=6 placebo) to receive two 0.5 mL intramuscular injections of AERAS-456 or
      placebo eight weeks apart, on Study Day 0 and Study Day 56.
    

Intervention name(s): H56:IC31; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): H56:IC31 contains a fusion protein (referred to as H56 antigen, or H56) of 3 mycobacterial antigens (the early secreted antigens Ag85B and ESAT-6, and the latency antigen Rv2660c).; The placebo consists of 10mM Tris and 169 mM NaCl pH 7.4.
Other intervention name(s): AERAS-456
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Study to Evaluate the QT / QTc Interval Prolongation Potential of Vericiguat
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study was to investigate whether there is a clinically
      meaningful effect on QTc change from baseline relative to placebo after administration of 10
      mg at steady state in patients with stable CAD (coronary artery disease).
    


Intervention name(s): Vericiguat (BAY1021189); Moxifloxacin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A : 2.5 mg vericiguat A*: 2.5 mg vericiguat B : 5 mg vericiguat C : 10 mg vericiguat C*: 10 mg vericiguat; D: 400 mg moxifloxacin; A : vericiguat placebo 10 mg A*: vericiguat placebo 10 mg + moxifloxacin placebo B : vericiguat placebo 10 mg C : vericiguat placebo 2.5 mg C*: vericiguat placebo 2.5 mg + moxifloxacin placebo D : vericiguat placebo 2.5 mg + vericiguat placebo 10 mg
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Vericiguat; Stable CAD; QT/QTc
Pharmacokinetic Study of OPC-1085EL Ophthalmic Solution in Healthy Male Adult Volunteers
Condition: Glaucoma; Ocular Hypertension
MeSH terms: Ocular Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      OPC-1085EL ophthalmic solution, carteolol long-acting ophthalmic solution or latanoprost
      ophthalmic solution are administered once daily for 7 days and the effect on the blood
      concentration of carteolol and latanoprost in OPC-1085EL ophthalmic solution by formulating
      the combination drug will be determined.
    


Intervention name(s): OPC-1085EL ophthalmic solution; Carteolol long-acting ophthalmic solution; Latanoprost ophthalmic solution
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Carteolol; Pharmaceutical Solutions; Latanoprost; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
To Investigate Drug-drug Interaction and Relative Bioavailability Between the FDC AzelastineHCL/Beclomethasone Dipropionate Nasal Spray, & Beclomethasone Dipropionate Nasal Spray in the Test Vehicle, and RinoClenil® Nasal Spray
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      An open label, randomized, three-treatment, three-period, crossover, single dose study, to
      investigate drug-drug interaction and relative bioavailability between the fixed dose
      combination Azelastine hydrochloride / Beclomethasone dipropionate (140/100 μg Azelastine
      hydrochloride / Beclomethasone dipropionate) Nasal Spray, and Beclomethasone Dipropionate
      Nasal Spray (100 μg Beclomethasone Dipropionate) in the test vehicle, and the commercially
      available product, RinoClenil® Nasal Spray (100 μg Beclomethasone Dipropionate), in healthy
      subjects under fasting conditions.
    


Intervention name(s): 140/100 μg Azelastine hydrochloride/Beclomethasone Dipropionate)
Intervention type(s): Drug
Intervention description(s): It will be nasaly administered
Other intervention name(s): 100 μg Beclomethasone dipropionate, Nasal Spray; RinoClenil® Nasal Spray (100 μg Beclomethasone Dipropionate)
Intervention MeSH terms: Azelastine; Beclomethasone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Effect of Prayer on Conditioned Pain Modulation and on Pain Intensity in Healthy Religious University Students
Condition: Healthy Subjects
MeSH terms: Pain
Study type: Interventional

Summary: 
      With this study the investigators wish to examine the effect of prayer on pain intensity and
      on the conditioned pain modulation in healthy religious university students.
    

Detailed description: 
      There has been a call for a model that incorporate spirituality in the biopsychosocial
      framework .The biopsychosocial- spiritual model recognizes the impact of the religious
      factors in modulating the biology of pain.

      The aim of this study is to measure the effect of praying as an intervention on conditioned
      pain modulation and on pain intensity.

      The investigators hypothesize that prayer would increase conditioned pain modulation compared
      to a no prayer control group in a healthy religious population.

      The investigators hypothesize that participants engaging in active prayer will show a higher
      increase in conditioned pain modulation compared to those engaging in passive prayer or no
      prayer.

      The present study is a randomized controlled trial comparing the effect of two types of
      prayer, the passive and the active prayer and no prayer, on conditioned pain modulation using
      the heat protocol and on pain intensity. Participants are to be randomly assigned to 2
      groups: the prayer group and the control group.

      The control group is of (n=50) participants and the prayer group is (n=150) participants to
      be divided according to the style of praying identified by the prayer function scale into
      active and passive prayer group.

      Appropriate statistical analyses will be performed to evaluate and compare treatment effects.
    

Intervention name(s): Prayer; Reading a poem
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Prayer is a non-pharmaceutical method of pain management and a form of alternative medicine.; Reading is a distraction tool for pain management
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Screening
JBT-101 in Systemic Lupus Erythematosus (SLE)
Condition: Systemic Lupus Erythematosus; SLE; Lupus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to evaluate the efficacy, safety, and tolerability of JBT-101
      (also known as lenabasum) in systemic lupus erythematosus (SLE).

        -  One hundred adults with active joint disease and at least moderate pain will be enrolled
           in this study to evaluate treatment of their systemic lupus erythematosus (SLE) with
           JBT-101. JBT-101 is a synthetic endocannabinoid receptor type 2 (CB2) agonist and an
           activator of the body's normal processes, to resolve innate immune responses without
           immunosuppression.

        -  Participants will receive 2 doses of JBT-101 by mouth (three groups of varying doses)
           or, placebo, for 84 days and will continue to be followed for an additional 28 days.
           Participant visits to assess endpoints occur on Day 1, then every 2 weeks twice, then
           every 4 weeks three times, for a total of six visits.

        -  The change in maximum daily pain Numerical Rating Scale (NRS) score from Baseline (Visit
           1) will be assessed at every visit.
    


Intervention name(s): JBT-101; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will self-administer JBT-101 by mouth (orally), at prescribed dose and frequency per protocol, Days 1-84. Administration of dose(s) should be at least 8 hours apart.; Participants will self-administer JBT-101 placebo by mouth (orally), at prescribed dose and frequency per protocol, Days 1-84. Administration of dose(s) should be at least 8 hours apart.
Other intervention name(s): lenabasum; anabasum; resunab; ajulemic acid; CT-3; IP751; CPL7075; JBT-101 placebo; lenabasum placebo
Intervention MeSH terms: Dronabinol; Lenabasum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: JBT-101 (also known as lenabasum); efficacy; musculoskeletal disease; randomized trial
Regorafenib in Patients With Relapsed Glioblastoma. IOV-GB-1-2020 REGOMA-OSS
Condition: Glioblastoma Multiforme
MeSH terms: Glioblastoma
Study type: Observational

Summary: 
      This study aims to analyze the role the of Regorafenib in prolonging the Overall Survival of
      glioblastoma multiforme patients who progressed after surgery and a first-line
      chemo-radiotherapy treatment in the setting of "real world life".
    

Detailed description: 
      The primary aim of the study
    

Intervention name(s): Regorafenib 40 MG Oral Tablet [STIVARGA]
Intervention type(s): Drug
Intervention description(s): As per the treating physicians discretion
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with relapse of glioblastoma (grade IV) after surgery and radio-chemotherapy first
        line treatment, treated with Regorafenib until disease progression or the appearance of
        unacceptable toxicity.
Hypertonic Saline-hetastarch in Cardiac Surgery
Condition: Postoperative Cardiorespiratory Failure
Study type: Interventional
Phase: Phase 4

Summary: 
      Cardiopulmonary bypass(CPB) is associated with increased fluid extravasation and edema
      formation. A continuous infusion of a mixture of hypertonic saline/hydroxyethyl starch
      (HSH)during CPB reduced fluid extravasation and total fluid gain during bypass in an animal
      model. We hypothesize that a continuous infusion of HSH will reduce fluid load and increase
      hemodynamic and respiratory functions in patients undergoing coronary artery bypass with CPB.
    

Detailed description: 
      Cardiopulmonary bypass (CPB) is associated with fluid overload and edema formation
      occasionally resulting in vital organ dysfunction affecting heart, respiratory system ,
      gastrointestinal tract and brain. Hyperosmolar/hyperoncotic preparations (HSH/HSD) have been
      used in cardiac surgery essentially with the aim to mobilize fluid excess and improve
      postoperative cardiorespiratory function.Most studies dealing with the administration of HSD
      or HSH during and after CPB, have used protocols recommended for treatment of severe
      hypovolemia and shock, that is 4 mL/kg as a bolus, given within minutes.In animal experiments
      we have used HSD or HSH, 1 mL/kg/h to a total dose of 4 mL/kg during CPB. The use of HSH/HSD
      reduced the total fluid gain about 50 % and resulted in significantly lower content of tissue
      water in vital organs as heart and lungs. In the actual clinical trial we hypothesize that a
      continuous infusion of HSH will reduce fluid load and increase hemodynamic and respiratory
      functions monitored with the PiCCO system in patients undergoing coronary artery bypass with
      CPB.
    

Intervention name(s): Hypertonic saline (7.2%) hetastarch (6 %)(200/0.5)
Intervention type(s): Drug
Intervention MeSH terms: Hydroxyethyl Starch Derivatives
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Fluid balance; respiratory function; cardiac function; inflammation; Cardiopulmonary bypass
Immunogenicity and Safety of Gardasil-9 and Cervarix
Condition: HPV Vaccines Immunogenicity and Safety
Study type: Interventional
Phase: Phase 3

Summary: 
      A ninevalent HPV vaccine (Gardasil-9) has been recently approved for clinical use. No data on
      immunogenicity and safety of interchangeable use of the ninevalent and the bivalent vaccine
      (Cervarix) are available. The main objective of this study is to assess the immunogenicity of
      ninevalent and bivalent HPV vaccines when administered to 9-10-year-old girls and boys
      according to 0-6 month schedule.
    

Detailed description: 
      The proportion of subjects with detectable antibodies and antibody geometrical mean titers to
      9 HPV genotypes included in the Gardasil-9 vaccine will be assessed 1 and 6 months post-first
      dose and 1, 18 and 36 months post-second dose of vaccine.
    

Intervention name(s): Immunogenicity two doses of Gardasil-9; Immunogenicity Cervarix and Gardasil-9
Intervention type(s): Biological; Biological
Intervention description(s): Subjects will receive two standard doses of Gardasil-9 (0.5 ml); Subjects will receive a standard dose of Cervarix (0.5 ml) and a standard dose of Gardasil-9 (0.5 ml)
Other intervention name(s): HPV vaccine; HPV vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: HPV vaccines, interchangeable use
A Bio-equivalence Study of Sofosbuvir From Elbanovir 400 mg Film Coated Tablets ( Multi-Apex Pharma, Egypt) & Sovaldi 400 mg Film Coated Tablets (Gilead Sciences, United Kingdom)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Comparative randomized, single dose, three way three sequence two treatment partial replicate
      crossover open-label study to determine the bioequivalence of Sofosbuvir from Elbanovir 400
      mg Film Coated Tablets ( Multi-Apex Pharmaceutical industries, Egypt) versus Sovaldi 400 mg
      Film Coated Tablets (Gilead Sciences International Ltd. Cambridge, United Kingdom)
    

Detailed description: 
      Primary Pharmacokinetic Parameters: Cmax, Area under cover (AUC0→t and AUC0→∞ ) Secondary
      Pharmacokinetic Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for
      transformed (with the 90% confidence intervals) and untransformed data of Cmax, AUC0→t and
      AUC0→∞ and for untransformed data of Ke, tmax and t1/2e. The confidence intervals of
      logarithmically transformed Test/Reference ratios for Cmax, AUC0→t and AUC0→∞ to be within
      80.00-125.00%.

      A comprehensive final report will be issued upon the completion of the study.
    

Intervention name(s): Elbanovir; Sovaldi; Sovaldi
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 tablet contains 400 mg sofosbuvir; 1 tablet contains 400 mg sofosbuvir; 1 tablet contains 400 mg sofosbuvir
Other intervention name(s): Sovaldi
Intervention MeSH terms: Sofosbuvir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Affect of Health Education on Statins Medication Persistence and ClinicaL Prognosis of Ischemic Stroke Patients (HELP)
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional

Summary: 
      The purpose of this study is to assess the affect of multiple health education interventions
      for statins medication Persistence and clinical prognosis of ischemic stroke patients at 3, 6
      and 12 months.
    

Detailed description: 
      The study is a prospective, multicenter, hospital-based study on secondary prevention for
      patients with ischemic cerebrovascular diseases between May 2014 and June 2015. Physicians
      from 24 hospitals in Beijing underwent a standard secondary prevention training of ischemic
      cerebrovascular diseases by professional training, instruction manuals, stratification
      management software. In order to improve the persistence of taking preventive secondary
      medicine, IS patients from these 24 hospitals received healthy education through manuals and
      Digital Video Disc about health education during hospitalization and acquired secondary
      preventive knowledge of ischemic cerebrovascular diseases through regular health education
      messages during 6 months after discharge. Patients with IS from other 6 hospitals were used
      as a control, and no such intervention was given to them.

      Telephone follow-up was performed at 3 months, 6 months, and 1 year after the onset of
      cerebral infarction, during which the use of antiplatelet and statins drugs and recurrence of
      IS were recorded. Patients who took antiplatelet drugs or statins at three follow-ups were
      regarded as persistent antiplatelet drugs or statins taking within one year after the onset
      of the disease. The main prognostic indicator was the recurrence of IS and persistence of
      statins medication within 1 year, and the main purpose was to explore the impact of
      persistent statins use on IS recurrence.
    

Intervention name(s): multiple health education interventions; conventional health education
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: ischemic stroke; Statins Medication Persistence; outcome
Complement Component 3c and Tumor Necrosis Factor-α in Patients With Human Papillomavirus-Induced Cutaneous Warts
Condition: Warts
MeSH terms: Warts; Necrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators explore the role of the complement pathway and T helper 1 immune response
      in clinical response to Candida immunotherapy via complement component and tumor necrosis
      factor, respectively.
    

Detailed description: 
      39 patients are enrolled in the study They suffer from chronic recurrent cutaneous warts
      Patients receive Candida antigen immunotherapy vial intra-lesional injection every 2 weeks
      till complete resolution or the maximum of 5 sessions Blood samples are withdrawn before and
      after intervention C3, C4, MBL, C3C and TNF alpha serum levels are measured
    

Intervention name(s): Candida antigen
Intervention type(s): Biological
Intervention description(s): Patient receive candida antigen immunotherapy and blood samples will be withdrawn before and after intervention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Bioequivalence Study of UH-AC 62 XX Tablets Compared With the Capsule Formulations in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate the bioequivalence of UH-AC 62 XX tablets 10 mg (TF4) and UH-AC 62 XX
      capsules 10 mg by single administration in healthy volunteers.
    


Intervention name(s): UH-AC 62 XX tablet; UH-AC 62 XX capsule
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of a Time Restricted Eating Protocol on Resistance Training Men
Condition: Fasting; Healthy
Study type: Interventional

Summary: 
      The study sought to investigate the effects of 16/8 time restricted eating (TRE) with windows
      of 16 hours of fasting and 8 hours of eating on on body composition, muscle strength, and
      metabolic factors during resistance training in healthy resistance trained males
    

Detailed description: 
      Thirty-four resistance-trained males were randomly assigned to a TRE group or to a control
      normal pattern group (ND) with a traditional meal pattern. The TRE group consumed 100% of the
      daily energy needs in an 8-hour time window: from 1PM (post meridiem) to 8:00 PM whilst the
      ND group consumed 100% of their daily energy needs in 3 meals between 8:00 AM (ante meridiem)
      and 8:00 PM. During the experimental period, training loads were similar and standardize in
      the two groups. partecipants were tested before and after 8 weeks of the intervention. Body
      composition , basal metabolism, performances indexes and blood parameters were measured.
      After the completition of the first two months of study, subjects were ask to volunteer to
      continue the intervention for 10 extra months. A total of twenty subjects from, 10 from each
      group (TRE or ND) continued and completed the second part of the study.
    

Intervention name(s): Time restricted eating; Normal Diet
Intervention type(s): Other; Other
Intervention description(s): TRE subjects consumed 100 % of their energy needs divided into three meals consumed at 1 p.m., 4 p.m. and 8 p.m., and fasted for the remaining 16 h per 24-h period.; ND group ingested their caloric intake as three meals consumed at 8 a.m., 1 p.m. and 8 p.m.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: It is a single blind, parallel arms study
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: fasting; time restricted eating; resistance training; body composition; inflammation