bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Switching From Entecavir to Tenofovir Disoproxil Fumarate in Subjects With Chronic Hepatitis B
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      Tenofovir Disoproxil Fumarate is a nucleos(t)ide analogue that inhibits Hepatitis B Virus
      (HBV) growth, and is marketed in Japan with an indication for inhibition of HBV growth in
      subjects with chronic hepatitis B associated with HBV growth and abnormal liver function.
      This study has been planned to evaluate the virological effects and safety of switching from
      ETV to TDF in chronic hepatitis B (hepatitis B e-antigen [HBeAg])-positive and HBV-
      deoxyribonucleic acid (DNA) undetectable subjects. This study is designed as a multi-center,
      one-arm, post-marketing clinical study to investigate the HBsAg reduction in subjects who
      have not achieved the long-term goal, the loss of hepatitis B surface antigen (HBsAg). The
      study will be conducted in HBeAg-positive and HBV-DNA undetectable subjects treated with ETV.
      After switching ETV to TDF, TDF will be administered for 96 weeks. Approximately 80 subjects
      will be screened to achieve 65 evaluable subjects.
    


Intervention name(s): Tenofovir Disoproxil Fumarate
Intervention type(s): Drug
Intervention description(s): Tenofovir Disoproxil Fumarate is a nucleos(t)ide analogue that inhibits HBV growth. All subjects will receive one tablet of TDF 300 mg once daily orally for 96 weeks.
Intervention MeSH terms: Tenofovir
Intervention model: Single Group Assignment
Intervention model description: This is a single arm study where on-going ETV treatment is switched to TDF treatment. There is no randomization in this study.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tenofovir Disoproxil Fumarate; safety; chronic hepatitis B; virological effect
Neurofunctional Predictors of Escitalopram Treatment Response in Adolescents With Anxiety
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Neurofunctional Predictors of Escitalopram Treatment Response in Adolescents with Anxiety. To
      determine the effects of escitalopram on functional activation patterns during a Continuous
      Performance Task with Emotional and Neutral Distracters, the CPT-END. To examine baseline
      functional activity and functional connectivity profiles in the ventrolateral prefrontal
      cortex as markers of subsequent treatment response to escitalopram in adolescents with
      generalized anxiety disorder (GAD). To use proton magnetic resonance spectroscopy (1H MRS) to
      examine glutamatergic and γ-aminobutyric acid (GABA)-related abnormalities in the anterior
      cingulate in adolescents with GAD as compared to healthy adolescents.
    

Detailed description: 
      The long-term goal of this study is to explore the neurobiological basis of generalized
      anxiety disorder (GAD) using a validated functional MRI (fMRI) paradigm and functional
      connectivity analyses with a cohort of GAD patients and healthy subjects and generating
      feasibility and preliminary data regarding treatment-related effects of escitalopram on brain
      functional activation and Fc patterns in pediatric GAD. An additional goal is to identify
      biological markers in saliva and urine that will predict treatment response in pediatric
      subjects with GAD. The central hypothesis of this proposal is that core dysfunction within
      the prefrontal-amygdala network, which the investigators and others have observed in GAD,
      will be normalized by successful treatment. The rationale underlying this hypothesis is that,
      despite the high prevalence of GAD, there is a need to understand its neurobiology and to
      identify biomarkers of treatment response and the mechanisms by which selective serotonin
      reuptake inhibitors (SSRIs) putatively effect changes in the neurocircuitry of pediatric GAD.
    

Intervention name(s): Escitalopram; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Patients being randomized to receive escitalopram.; Patients being randomized to receive placebo.
Other intervention name(s): Lexapro; Sugar Pill
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Anxiety; Adolescents with Anxiety
Progesterone for the Prevention of Miscarriage and Preterm Birth in Women With First Trimester Bleeding: PREEMPT Trial
Condition: Miscarriage; Preterm Birth
MeSH terms: Premature Birth; Abortion, Spontaneous
Study type: Interventional
Phase: Phase 2

Summary: 
      Miscarriages and preterm births are common and serious events affecting women, families, and
      healthcare systems on many levels. One of the risk factors for miscarriage and preterm birth
      is bleeding in the first trimester of pregnancy. Progesterone, a hormone that plays a key
      role during pregnancy, has been proposed as a possible medication to be used in pregnancy to
      prevent miscarriage and preterm birth among women who have bleeding in their first trimester
      of pregnancy. Unfortunately, unless sound clinical evidence is obtained through a clinical
      trial, whether or not progesterone can indeed prevent miscarriage and preterm birth remains
      uncertain and thus is not a recommended treatment in women with early pregnancy bleeding. The
      purpose of our study is to evaluate the effect of progesterone for the prevention of
      miscarriage and preterm birth among women with early pregnancy bleeding. We will carry out a
      clinical trial in which 850 women will be randomized to receive either progesterone
      supplementation (425 women) or a similarly appearing placebo (425 women) and the outcome of
      their pregnancy will be compared.
    


Intervention name(s): Progesterone; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
BTRX-246040 Administered Once Daily to Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will determine the efficacy, safety, and tolerability of a once-daily (QD) dose of
      up to 80 mg of BTRX-246040 for 8 weeks in participants with MDD.
    


Intervention name(s): BTRX-246040 oral capsule(s); Placebo oral capsule(s)
Intervention type(s): Drug; Drug
Intervention description(s): BTRX-246040 administered once daily to patients with MDD for 8 weeks; administered once daily to patients with MDD for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; Anhedonia; antidepressant; Nociceptin; NOPR
Methemoglobinemia After Liposuction - Diagnostic by Pulse Oximetry and Blood Gas Analysis.
Condition: Methemoglobinemia
MeSH terms: Methemoglobinemia
Study type: Observational

Summary: 
      Tumescent local anesthesia is a procedure which is frequently performed for plastic cosmetic
      surgical procedures such as liposuction. The subcutaneous adipose tissue is infiltrated with
      large volumes of a solution which also contain local anesthetics. However local anesthetics,
      can also lead to a marked production of methemoglobin. New generation pulse oximeters are
      able to measure SpMetHb non-invasivly.

      The aim of this study is:

        1. to investigate multi-wavelength pulse oximetry as a monitoring method for patients at
           increased risk for methemoglobinemia.

        2. to illustrate MetHb concentrations over a course of 24 hours after a liposuction
           employing tumescent anesthesia has been carried out.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        - female patients scheduled for liposuction
      
Keywords: pulse oximetry; tumescent anesthesia
Impact of C3F8 or SF6 Use and Length of Face-down Positioning (7 vs 14 Days Respectively) in Macular Hole Surgery
Condition: Macular Holes; Visual Acuity Gain; Cataract; Complications
MeSH terms: Cataract; Retinal Perforations
Study type: Interventional

Summary: 
      The primary purpose of the study was to compare the macular hole closure and visual acuity
      gain following vitrectomy using SF6 gas tamponade with 7 days of face-down positioning versus
      C3F8 gas tamponade with 14 days of face-down positioning.

      The secondary purpose was to report, in each group, the cumulative incidence of cataract
      development 1 year following macular hole surgery and the proportion of complications (*).

      ((*) hypertony, hypotony, retinal tear, retinal detachment and endophthalmitis) This
      prospective randomized study examined a 3 year period. The first patient was included in
      January 2010 and the last in November 2011. The 12-month follow-up spread out from March 2011
      to December 2012. The first group included 31 patients who had undergone macular hole surgery
      using SF6 gas and who were advised to stay in face-down position for 7 days postoperatively
      (SF6 group). These patients were compared to 28 patients who had undergone macular hole
      surgery with C3F8 gas and who were advised to maintain a face-down position for 14 days.
      Patients in both groups underwent vitrectomy, internal limiting membrane peeling, and
      fluid-gas exchange using either SF6 or C3F8.

      Preoperative data included the characterization of the hole with Optical Coherence Tomography
      (OCT), the best correct visual acuity (VA) recorded in number of letters using the Early
      Treatment Diabetic Retinopathy Study (ETDRS) chart, classification of the cataract according
      to the LOCS III and the intraocular pressure IOP. Postoperative data included OCT
      confirmation of the closure at 6 weeks and 1 year, 1 year's best corrected VA recorded in
      number of letters (EDTRS chart) and determination of cataract development and extraction as
      needed.
    


Intervention name(s): Macular hole surgery using a 25 G pars plana vitrectomy, ILM peeling, fluid-air exchange followed by air-gas exchange with SF6 or C3F8.
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Using of Injectable Platelet Rich Fibrin on Filling the Gap of Immediate Dental Implant
Condition: Bone Loss
Study type: Interventional

Summary: 
      The effect of using of i-PRF (injectable platelet rich fibrin) on filling the gap of
      immediate dental implant in the esthetic zone
    

Detailed description: 
      Grouping the samples: (sixteen patients was recruited from the outpatient clinic of Oral
      Medicine, Periodontology, Diagnosis and Radiology Department, Faculty of Dentistry, Ain Shams
      University).

      The sixteen patients assigned to group 1 or group 2 will be randomly allocated using flip of
      a coin into one of the 2 treatment modalities.

      Primary objective:

      Radiograhic evaluation of the effect of i-PRF on filling the buccal gap distance between the
      immediately placed dental implant and the surrounding bone.

      Secondary objective:

      Esthetic evaluation of the effect of i-PRF on the soft tissue around immediately placed
      dental implant.
    

Intervention name(s): injectable platelet rich fibrin
Intervention type(s): Other
Intervention description(s): biologic activator
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group I (study group)8 patients undergo flapless single immediate implant placement surgery with filling the gap distance with i-PRF& bone graft
Group II (control group) 8 patients undergo flapless single immediate implant placement surgery with filling the gap distance with bone graft
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Other
Penehyclidine for PONV Prophylaxis After Strabismus Surgery
Condition: PONV
MeSH terms: Strabismus
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients scheduled for elective strabismus surgery under general anesthesia in the First
      Affiliated Hospital of Nanjing Medical University will be included in this study.

      Patients 1)ASA I or II, 2)aged 3-65 years, 3)scheduled for elective strabismus surgery under
      general anesthesia, will be included in the study. Patients 1)had prior PONV, 2)severe motion
      sickness, 3)a history of ophthalmic surgery, 4)had received drugs known to have antiemetic
      effects, will be excluded from the study.

      The primary aim is to evaluate the prophylaxis effect of penehyclidine(a novel long acting
      selective anticholinergic agent developed in China) on postoperative nausea and vomiting
      after strabismus surgery. Secondary outcomes include the effect of PONV risk factors and
      surgical technique on PONV rank score, occurance of oculocardiac reflex, time to extubation.
    


Intervention name(s): Penehyclidine; normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Patients receive penehyclidine 10μg/kg(up to 0.5mg, diluted with normal saline to 0.1mg/ml) after anesthesia intubation.; Patients receive 0.1ml/kg normal saline(up to 5ml) after anesthesia intubation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Penehyclidine; PONV
Determination of Gentamicin Dosing in Neonatal Patients
Condition: Infection
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine what dosage of gentamicin for use in one-time
      administration device (Uniject) is appropriate.
    

Detailed description: 
      This study aims to verify dosages of gentamicin for use in Uniject, chosen based on a
      consideration of gentamicin pharmacokinetics, safety, efficacy, target population body
      weight, cost, feasibility and acceptability.
    

Intervention name(s): Gentamicin in Uniject Pre-filled syringe
Intervention type(s): Drug
Intervention MeSH terms: Gentamicins
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: meningitis; neonatal deaths; gentamicin; Uniject; aminoglycoside
Double Blind, Placebo Controlled Study to Assess Efficacy of AIN457 in Moderate to Severe Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Interventional
Phase: Phase 2

Summary: 
      Evaluate the safety, tolerability and pharmacokinetics of AIN457 when administered as
      treatment of moderate to severe ankylosing spondylitis (AS).
    


Intervention name(s): AIN457; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): AIN457A is a fully human recombinant IgG1 antibody that targets and neutralizes IL-17A.; Placebo to AIN457
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: ankylosing spondylitis
Metformin as a Novel Therapy for Autosomal Dominant Polycystic Kidney Disease
Condition: Polycystic Kidney, Autosomal Dominant
MeSH terms: Arthrogryposis; Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will test to see if metformin is safe and if it is tolerated compared to placebo
      in adult Autosomal Dominant Polycystic Kidney Disease (ADPKD) patients with beginning stages
      of chronic kidney disease. We will also measure its effect on progression of kidney disease
      as reflected in the kidney size and the kidney function, along with its effect on kidney pain
      and quality of life.
    

Detailed description: 
      There is growing evidence that metformin, a drug widely used for the treatment of type 2
      diabetes and polycystic ovary syndrome, may serve as a novel therapy for individuals in the
      early stages of Autosomal Dominant Polycystic Kidney Disease ADPKD by activating the
      metabolic sensor AMP-activated protein kinase (AMPK). AMPK is activated under conditions of
      metabolic and other cellular stresses. Through its actions on downstream mediators, AMPK
      activation during low energy states decreases cellular energy consumption while stimulating
      energy generating pathways. It has been shown that AMPK phosphorylates and inhibits cystic
      fibrosis transmembrane conductance regulator (CFTR), thus suppressing epithelial fluid and
      electrolyte secretion. Similarly, AMPK phosphorylates the tuberin protein, leading to
      indirect inhibition of the mTOR pathway. Thus, AMPK inhibits both CFTR and mTOR, suggesting
      that targeted activation of this kinase by metformin may provide a therapeutic benefit in
      ADPKD. It has been shown that metformin treatment of kidney epithelial cells leads to
      stimulation of AMPK and subsequent inhibition of both mTOR and CFTR activity. It has also
      been shown that metformin slows cystogenesis in animal models of PKD, supporting the
      potential of this drug in ADPKD treatment.
    

Intervention name(s): Metformin; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Monitoring of tolerability and symptoms.; Monitoring of tolerability and symptoms.
Other intervention name(s): Glucophage; Metformin hydrochloride
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: kidney disease; polycystic kidney disease; autosomal dominant kidney disease; kidney cysts; PKD
To Test the Effect of Selected Fibres and Flours in Flat Bread on Post-Prandial Blood Glucose and Insulin Responses in Healthy Indian Population
Condition: Healthy
Study type: Interventional

Summary: 
      Double-blind, randomized, controlled, cross-over design with 3 test products and one control
      product.

      To evaluate the effect of 4 different flour compositions (guar gum 2% and 4%, chickpea flour
      15% and barley flour 2% and 5%) of selected fibres and flours, on post-prandial plasma (PPG)
      and serum insulin levels in healthy Indian subjects, after the consumption of flat bread made
      from 100 gram of flour compositions.
    


Intervention name(s): Control (market standard); wheat flour; chickpea flour; guar gum; barley
Intervention type(s): Other; Other; Other; Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Basic Science
Keywords: Blood glucose, serum insulin
MSCs For Treatment of Azoospermic Patients
Condition: Male Infertility
MeSH terms: Infertility; Infertility, Male
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      In this study, we performed autologous BMDMSC transplantation to the testis of Azoospermic
      patients in a trial to enhance and activate the spermatogonial stem cells of the testis and
      aiming to produce motile sperm.
    

Detailed description: 
      Bone marrow aspirated and stem cells were isolated, cultured and characterized using flow
      cytometer. Stem cells prepared according to GMP regulations then injected into rete testis
      using special syringe. Patients follow up will carried out for a year , three month interval.
      FSH, testosterone, testicular size as well as sexual potency will assessed every three
      months.
    

Intervention name(s): Stem Cells
Intervention type(s): Biological
Intervention description(s): 60 ml of bone marrow will aspirated and used for stem cells isolation. Then stem cells will cultured using autologous serum, characterized and prepared using GMP rules and finally injected into rete testis.
Other intervention name(s): Stem Cell Dose; 3-5 Million Autologous MSCs Injected into rete testis.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Azoospermia, Spermatogonial Arrest, Maturation Arrest.
Hand Assistive Rehabilitation Orthotic Device Effectiveness Study
Condition: Orthoses; Prostheses
Study type: Interventional

Summary: 
      The primary objective of this study is to evaluate pinch strength improvements and
      improvements in coordination and functional ability. Pinch strength measurements are made on
      subjects both with and without the device to evaluate the potential improvements. Also,
      coordination and functional testing is performed both with and without the device to compare
      performance under both conditions and evaluate potential improvement.
    

Detailed description: 
      This study tests the powered hand orthosis device on a small number of participants (up to
      6). Research participants with neuromusculoskeletal impairments were recruited for the study
      and consented with an approved protocol. The study was conducted during 1 visit to LTI in
      Holliston, MA . The study consists of several assessments. Participants are surveyed for
      cognitive limitations and self-assessment of difficulties in completing tasks of daily living
      by completing surveys such as the Quickdash Questionnaire [1], the Mini-Mental State test
      [2], and the McGann Feedback form [3]. Pinch strength without and with the powered orthosis
      is evaluated. A selection of functional outcome measures are performed such as the
      Southampton Hand Assessment Procedure (SHAP) [4], the Nine-Hole Peg Test (NHP) [5], and the
      Box and Blocks Test (BBT) [6].
    

Intervention name(s): Powered Hand Orthosis
Intervention type(s): Device
Intervention description(s): A prototype powered hand orthosis system designed to improve grip strength and improve ability to perform tasks of daily living.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Effect on Primary Dysmenorrhea
Condition: Primary Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      To investigate the potential benefits of a new oral contraceptive (SH T00658ID) on
      alleviating complaints of dysmenorrhea associated with oral contraceptive use.
    


Intervention name(s): Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027); Ethinyl estradiol, Levonorgestrel (Miranova); Placebo Match to SH T00658ID; Placebo Match to SH D593B
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Daily oral administration of one tablet SH T00658ID for 28 days per cycle in the respective treatment period; no tablet-free interval; Daily oral administration of one tablet for 28 days per cycle in the respective treatment period; no tablet-free interval; Daily oral administration of one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles.; Daily oral administration of one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles.
Intervention MeSH terms: Dienogest; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Levonorgestrel; Ethinyl Estradiol; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Primary Dysmenorrhea; Oral Contraception