bioihbjkbjnl/mcl2 huggingface dataset:
deLIVER: Direct Acting Antiviral Effects on the Liver
Condition: HCV Coinfection; Liver Disease; HIV
MeSH terms: Coinfection; Liver Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      Open-label, partially-randomized plasma and liver sampling study to assess hepatitis C virus
      (HCV) kinetics during treatment with two (Sofosbuvir/Velpatasvir) or three
      (Sofosbuvir/Velpatasvir/Voxilaprevir) direct acting antivirals (DAAs)
    

Detailed description: 
      Primary Objective: The primary objective is to estimate the 1-week change in the proportion
      of HCV-infected hepatocytes in participants with HCV monoinfection and HIV/HCV coinfection on
      therapy with two or three DAAs with different mechanisms of action using single cell laser
      microdissection (scLCM).

      Secondary Objectives:

      Estimate the change over the first week in plasma HCV RNA in subjects with HCV monoinfected
      and HIV/HCV coinfected participants on therapy with two or three DAAs

      Estimate the 1 week change in the amount of HCV RNA per infected hepatocyte using scLCM on
      liver biopsy specimens, obtained just prior to treatment initiation (pre-treatment), and
      after the first week of DAA therapy.

      Estimate the change in the proportion of HCV-infected hepatocytes that express
      interferon-stimulated genes (ISGs) within the first week of DAA therapy using scLCM.

      Measure the change in expression of ISGs in non-parenchymal intrahepatic immune cells
      (Kupffer cells, plasmacytoid dendritic cells) within the first week of DAA therapy using
      scLCM.

      Exploratory Objectives:

      Estimate the 1 week change in expression of ISGs from peripheral blood mononucleated cells
      (PBMCs) within the first week of DAA+ribavirin (RBV) therapy using scLCM.

      Compare sequence(s) of HCV protease, nonstructural protein 5A (NS5A), and nonstructural
      protein 5B (NS5B) depending on the peripheral sequence) of intrahepatic HCV RNA in single
      cells and bulk tissue, before and during week 1 of DAA+RBV therapy.

      Estimate the week 1 change in the sizes and numbers of HCV-infected clusters on DAA therapy
      to test whether clearance of HCV-infected hepatocytes occurs in spatially random patterns or
      within specific clusters.
    

Intervention name(s): Sofosbuvir/Velpatasvir/Voxilaprevir [SOF/VEL/VOX]; Sofosbuvir/Velpatasvir (SOF/VEL)
Intervention type(s): Drug; Drug
Intervention description(s): antiviral therapy for HCV; antiviral therapy for HCV
Intervention MeSH terms: Sofosbuvir; Velpatasvir; Sofosbuvir-velpatasvir drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Epidural Nalbuphine for Postcesarean Epidural Morphine Induced Pruritus
Condition: Cesarean Section
MeSH terms: Pruritus
Study type: Interventional
Phase: Phase 4

Summary: 
      Can epidural nalbuphine reduce incidence or severity of epidural morphine induced pruritus in
      patient undergoing cesarean section?
    

Detailed description: 
      182 parturients,ASA 1-2 undergoing cesarean section under epidural block were enrolled in the
      study. After obtaining informed consent,all received epidural anesthesia using 2% lidocaine
      with epinephrine 1:200000 via epidural cathetes at L2-3 or L3-4 in a volume suffient to
      achieve a T4 sensory level bilaterally.

      After the umbilical cord was clamped,patients were assigned randomly to three groups.The
      placebo group,N-5 group,and N-10 group received 4 ml epidural solution containing morphine 4
      mg plus either saline, nalbuphine 5 mg, and nalbuphine 10 mg respectively.At the post
      anesthetic care unit, intravenous pethidine PCA were administered for inadequate pain
      control.

      Outcome measures :

      Incidence and severity of postoperative pruritus Quality of pain control Side effects of
      epidural morphine and nalbuphine such as respiratory depression,sedation
    

Intervention name(s): nalbuphine; nalbuphine; NSS
Intervention type(s): Drug; Drug; Other
Intervention description(s): nalbuphine 5 mg epidural; nalbuphine 10 mg epidural; NSS
Other intervention name(s): nubain; nubaine; nornal saline
Intervention MeSH terms: Nalbuphine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: pruritus; epidural morphine
Short Term Oral Iron Supplementation in Systolic Heart Failure Patients Suffering From Iron Deficiency Anemia
Condition: Heart Failure, Systolic; Iron-deficiency Anemia
MeSH terms: Heart Failure; Heart Failure, Systolic; Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases; Systolic Murmurs
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine the efficacy of Ferrous Sulphate (FS) tablets in
      improving iron stores and functional capacity in HF patients with Iron Deficiency Anemia
      (IDA).
    

Detailed description: 
      The investigators conducted a double blind randomized controlled trial (RCT) enrolling 54
      Heart Failure (HF) patients (LVEF < 50%) with IDA (Ferritin < 100 ng/mL or 100-300 ng/mL with
      Tsat < 20%) at outpatient clinic of National Cardiovascular Center Harapan Kita from January
      to July 2016. Patients were randomized 1:1 to received FS or placebo for 90 days, the
      investigators then evaluated the change in 6-Minute Walking Test (6MWT) distance as primary
      end-point and changes on N-Terminal-pro Brain Natriuretic Peptide (NT-proBNP) and post 6MWT
      serum lactate levels as secondary end-points.
    

Intervention name(s): Ferrous Sulfate; Placebo Oral Capsule
Intervention type(s): Drug; Drug
Intervention description(s): Ferrous sulfate 200 mg t.i.d for 90 days; Lactose 200 mg t.i.d for 90 days
Other intervention name(s): Ferrous Sulfate oral capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Systolic Heart Failure; Anemia; Iron Deficiency
Characterization of Sitting Postures in Healthy Subjects
Condition: Pressure Ulcer
MeSH terms: Pressure Ulcer
Study type: Interventional

Summary: 
      The aim of this study is to assess the intra and inter-subjects variability of the pressure
      measurement cartography in healthy and well and able volunteers, sitting on a rigid base
      during two hours.
    

Detailed description: 
      -  The purpose of this study is to understand the formation of pressure sore, to improve
           the care of paraplegic patients.

        -  This pilot study is going to help to establish a model in healthy volunteers in the
           prevention of pressure sores.
    

Intervention name(s): Orthotest CE
Intervention type(s): Device
Intervention description(s): Orthotest CE is a rigid base mapping system composed by 1024 pressure transducers uniformly distributed in a 35x35 cm surface.
Orthotest CE is a product manufactured by Vista-Medical. The patient sit on the rigid base during 2 hours to record the pressure and all the data needed for the pilot study.
Pressure measurement
Other intervention name(s): Orthotest CE mark; Vista-Medical; Mapping system
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pressure Ulcer; prevention
Efficacy Study Comparing the Effect of Clomiphencitrate to an Antagonist Protocol
Condition: Female Infertility; Ovarian Insufficiency
MeSH terms: Infertility; Infertility, Female
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to assess the oocyte yield of infertile women with suspected or
      known poor ovarian reserve (POR) undergoing a GnRH antagonist protocol for IVF with Merional®
      starting either with a low (150 IU) or a high dose (450 IU) and adding 100mg of CC
      (Serophene®) in the early follicular phase of the stimulation (day 3 to 7). To date no RCT
      has been conducted to compare the reproductive outcome of patients with POR as defined by the
      ESHRE Bologna criteria after controlled ovarian hyperstimulation with HMG in an GnRH
      antagonist protocol using low doses versus high doses of HMG and adding CC versus placebo. We
      hypothesize that adding 100 mg of CC on day 3-7 to a HMG antagonist protocol will lead to an
      additional increment of endogenous GT thus increasing the oocytes yield after controlled
      ovarian stimulation due to higher endogenous gonadotropin secretion.
    


Intervention name(s): High Dose Clomiphencitrat; Low Dose Clomiphencitrat; High Dose Placebo; Low dose Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 100mg of clomiphencitrate(Serophene®) are added to a high dose of HMG (450 IU of Merional®) in the early follicular phase of the stimulation (day 3 to 7).; 100mg of clomiphencitrate(Serophene®) are added to a low dose of HMG (150 IU of Merional®) in the early follicular phase of the stimulation (day 3 to 7).; Placebo is added to a high dose of HMG (450 IU of Merional®) in the early follicular phase of the stimulation (day 3 to 7).; Placebo is added to a low dose of HMG (150 IU of Merional®) in the early follicular phase of the stimulation (day 3 to 7).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: female infertility; poor ovarian response; controlled ovarian hyperstimulation; IVF; Antagonist protocol
Workshops for Toddlers With Speech and Language Developmental Delay
Condition: Developmental Delay
Study type: Interventional

Summary: 
      The purpose of this study is to identify the therapeutic effects of family workshops on
      speech and language developmentally delayed children and their family
    

Detailed description: 
      The family workshop with 5 courses, 6 families in one course, a 2-hour session per week, for
      6 weeks.

      Effects:

        1. Investigate the therapeutic effects of the workshop for the toddlers with developmental
           delay

        2. Investigate the therapeutic effects of the workshop for the parents of toddlers with
           developmental delay
    

Intervention name(s): family workshop
Intervention type(s): Other
Intervention description(s): The family workshop with 5 courses, with 6 families in one course The intervention of one course; 2 hours per session, one time per week, for a total of 6 weeks
Intervention model: Single Group Assignment
Intervention model description: Intervention group
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: family workshop
Efficacy of Simeox Airway Clearance Therapy in Children With Cystic Fibrosis
Condition: Cystic Fibrosis in Children; Airway Clearance Impairment
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      Chest physiotherapy plays a crucial role in treatment of lung disease in cystic fibrosis
      (CF). New airway clearance techniques (ACTs) adapted to individual needs are still being
      sought to achieve the best effect of airway clearance. The primary aim of this study is to
      assess the efficacy of a new ACT (Simeox) on pulmonary function in children with CF. 40 CF
      patients with stable respiratory function will be randomized 1:1 to Simeox or conventional
      chest physiotherapy (CCPT) therapy (control group) and treated at home during 1 month. After
      a short washout period, patients will be treated at home onto the alternative treatment for 1
      month (crossover design). Lung function, quality of life, pulmonary exacerbation and safety
      will be evaluated at 1 month for each therapy period.
    


Intervention name(s): Simeox; CCPT
Intervention type(s): Device; Other
Intervention description(s): Airway clearance device; Conventional chest physiotherapy
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Airway clearance technique
A Pilot Study to Determine the Efficacy of a Low Carbohydrate Diet in Treatment of Adolescents With Metabolic Syndrome
Condition: Elevated Triglycerides; Systolic Hypertension; Insulin Resistance; Abdominal Obesity
MeSH terms: Isolated Systolic Hypertension; Metabolic Syndrome; Insulin Resistance; Obesity, Abdominal; Hypertriglyceridemia
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effectiveness of two different non-energy
      restricted controlled carbohydrate programs with the American Diabetes Associations' diet on
      glycosylated hemoglobin and other diabetes risk factors in obese adolescents with metabolic
      syndrome, a constellation of symptoms associated with the development of type 2 diabetes and
      cardiovascular disease.
    

Detailed description: 
      The purpose of this study is to determine the effectiveness of two different non-energy
      restricted controlled carbohydrate programs with the American Diabetes Associations' diet on
      glycosylated hemoglobin and other diabetes risk factors in obese adolescents with metabolic
      syndrome, a constellation of symptoms associated with the development of type 2 diabetes and
      cardiovascular disease.

      We plan to address the following issues:

        1. To test the hypothesis that a controlled carbohydrate nutrition plan will be superior to
           the standard ADA diet in controlling blood sugar (as measured by glycosylated hemoglobin
           [HbA1C]), decreasing cardiovascular risk factors (Serum Lipid Levels, Blood Pressure)
           and decreasing weight in adolescents with metabolic syndrome

        2. To evaluate the tolerability of a non-energy restricted very-low carbohydrate diet in
           these patients as measured by the SF-10 for Children, the Brief Symptom Inventory (BSI)
           and a scaled questionnaire regarding side effects.

        3. To compare two different maintenance programs in the group who receive the non- energy
           restricted very-low carbohydrate diet and compare each group to the group
    

Intervention name(s): standard ADA diet; energy restricted very-low carbohydrate diet; low glycemic diet
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): standard ADA diet; energy restricted very-low carbohydrate diet; restricted ketogenic diet
Other intervention name(s): ketogenic diet.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ADA diet; low carbohydrate diet; Metabolic syndrome
Tear Cytokine Analysis as a Prediction or Diagnostic Marker in Ocular GvHD
Condition: Chronic Graft-versus-host Disease
MeSH terms: Bronchiolitis Obliterans Syndrome; Graft vs Host Disease
Study type: Observational

Summary: 
      Investigate the profiles of tear cytokines in patients who underwent stem cell
      transplantation (SCT) and attempted to determine the applicability of tear cytokines in the
      diagnosis of chronic graft-versus-host disease (GVHD). Evaluate tear cytokines as biomarkers
      of chronic ocular GVHD severity.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Male or non-pregnant female patients aged 20-60 years who visited the clinic 3-12 months
        after SCT were included in the study.
      
Biospecimen description: 
      TEAR
    
Keywords: stem cell transplantation (SCT)
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Repeat Doses of GSK2982772 in Subjects With Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is the first study with GSK2982772, a receptor-interacting protein-1 (RIP1) kinase
      inhibitor, in subjects with active plaque-type psoriasis (PsO). The primary objective will be
      to investigate the safety and tolerability of repeat oral doses of GSK2982772 60 milligram
      (mg) twice daily (BID) for 84 days in Cohort 1 and 60 mg thrice daily (TID) for 84 days in
      Cohort 2. In addition, a number of experimental and clinical endpoints will be employed to
      obtain information on the pharmacokinetics, pharmacodynamics, and efficacy in subjects with
      active PsO. There will be two Cohorts of subjects. In Cohort 1 after a screening period of up
      to 30 days, approximately 30 subjects will be randomized to receive either GSK2982772 60 mg
      BID or placebo for 84 days (12 Weeks), followed by a follow-up period (28 days). In Cohort 2
      after a screening period of up to 30 days, approximately 24 subjects will be randomized to
      receive either GSK2982772 60 mg TID or placebo for 84 days (12 Weeks), followed by a
      follow-up period (28 days). The total duration of participation is approximately 20 Weeks
      from screening to the last study visit.
    


Intervention name(s): GSK2982772; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GSK2982772 will be supplied as a white to almost white, round, film coated 30 mg oral tablets; two tablets to be taken in the morning and two in the evening, as directed for Cohort 1 and for Cohort 2 two tablets to be taken three times daily as directed.; Matching placebo will be supplied as a white to almost white, round film coated tablets; two tablets to be taken in the morning and two in the evening, as directed for Cohort 1 and for Cohort 2 two tablets to be taken three times daily as directed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: tolerability; safety; GSK2982772; RIP1 kinase inhibitor; psoriasis
Radlink GPS Provide a Valid Intra-operative Assessment of Acetabular Inclination and Anteversion
Condition: Implant Position in Total Hip Replacement
Study type: Observational

Summary: 
      Evaluate the accuracy of Radlink System in determining acetabular cup placement and limb
      length evaluation during Anterior hip replacement as measured intraoperative with C-Arm
      visualization and confirmed with digital x-ray at 4-6 weeks postoperatively.
    

Detailed description: 
      Evaluate the accuracy of Radlink System in determining acetabular cup placement and limb
      length evaluation during Anterior hip replacement as measured intraoperative with C-Arm
      visualization and confirmed with digital x-ray at 4-6 weeks postoperatively.

      GPS may improve total hip replacement by allowing surgeons to measure the exact position of
      components placed during surgery and there is a question whether RADLINK helps surgeons place
      the acetabular cup (the part that goes into the hip bone) component in a precise position.
      The objective of the study is to determine whether GPS gives surgeons reliable, valid
      information about the orientation of the cup component. The surgeons need to collect data to
      help clarify this issue.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patient under going total hip replacement
Immunogenicity and Safety of V419 (PR51) in Combination With MCC in Infants and Toddlers (V419-011)
Condition: Neisseria Meningitidis; Bacterial Infections; Virus Diseases
MeSH terms: Bacterial Infections; Virus Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objectives of this study are to evaluate the immunogenicity and safety of
      concomitant administration of V419 (PR51) with 2 types of meningococcal serogroup C conjugate
      (MCC) vaccines to healthy infants at 3 and 4 months of age in terms of antibody
      seroprotection rate (SPR) to MCC. Participants also received a Haemophilus influenza type B
      (Hib)-MCC vaccination at 12 months of age. It was hypothesized that the SPR to MCC at 1 month
      post-dose 2 of either tetanus toxoid conjugated Meningo C (MCC-TT) or CRM197 conjugated
      Meningo C (MCC-CRM) vaccines would be acceptable when administered concomitantly with V419.
    


Intervention name(s): V419; PREVNAR 13®; MCC-TT; MCC-CRM; Hib-MCC; MMR Vaccine
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Diphtheria and Tetanus toxoids and acellular Pertussis adsorbed, inactivated Poliovirus, Haemophilus b conjugate [meningococcal outer membrane protein complex], and Hepatitis B [recombinant] vaccine administered via 0.5 mL intramuscular injection.; Pneumococcal conjugate vaccine (13-valent, adsorbed) administered via 0.5 mL intramuscular injection (routine vaccination).; Meningococcal Group C polysaccharide conjugate vaccine to tetanus toxoid adsorbed 0.5 mL intramuscular injection at 3 and 4 months of age; Meningococcal Group C conjugate vaccine to CRM-197 adsorbed 0.5 mL intramuscular injection at 3 and 4 months of age; Haemophilus type b and meningococcal Group C conjugate vaccine administered via 0.5 mL intramuscular injection.; Measles, mumps, and rubella vaccine (live) given via 0.5 mL intramuscular injection (routine vaccination).
Other intervention name(s): PR51, VAXELIS®; NEISVAC-C®; MENJUGATE®; MENITORIX®; M-M-RVAXPRO®
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Propofol or Midazolam for Sedation and Early Extubation Following Coronary Artery Bypass Graft Surgery
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      Propofol and midazolam are used frequently as sedating agents among patients who undergo
      coronary artery bypass graft surgery but no study in Pakistan has been done to compare their
      effectiveness aiming early extubation.
    

Detailed description: 
      Propofol is an intra lipid and alkali phenol chemically it is unrelated to sedative agents or
      anaesthetic. Midazolam is a banzodiazepen. Most of its properties are similar to diazepam. It
      is a common practice to use sedatives to provide comfort and decrease "ventilator-asynchrony"
      in critically ill patients that may require prolonged invasive mechanical ventilation. The
      other reason to employ sedatives is to reduce the anxiety associated with the inaviseve
      procedures routinely conducted in the ICU.
    

Intervention name(s): Midazolam
Intervention type(s): Drug
Intervention description(s): Midazolam infusion will be given after the surgery as 0.25 mg/kg/min.
Other intervention name(s): Versed
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Radomized Controlled Trial
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: coronary artery bypass graft; midazolam; propofol
A Study to Determine the Safety and Efficacy of NT-501 in Macular Telangiectasia Type 2
Condition: Macular Telangiectasia Type 2
MeSH terms: Telangiectasis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a phase 3, randomized, multi-center study to evaluate the efficacy and safety
      of the NT-501 implants in participants with macular telangiectasia type 2.
    


Intervention name(s): NT-501; Sham
Intervention type(s): Combination Product; Procedure
Intervention description(s): Surgery to receive one NT-501 device implant.; Non-penetrating sham procedure to mimic implant procedure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ciliary Neurotrophic Factor (CNTF); Macular Telangiectasia (MacTel)