bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Tenofovir Disoproxil Fumarate in Adolescents With Chronic Hepatitis B Infection
Condition: Hepatitis B Virus (HBV)
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of the study is to evaluate the effectiveness, safety, and tolerability
      of tenofovir disoproxil fumarate (TDF) in adolescents (aged 12-17 years) with chronic
      hepatitis B virus (HBV) infection.

      The optimal treatment for adolescents with chronic HBV infection is currently unknown.
      Treatment with interferon alfa, lamivudine, and adefovir dipivoxil in pediatric populations
      has been shown to be less than optimal. Further, the safety and efficacy of entecavir and
      telbivudine have not been established in patients < 16 years of age. A study evaluating TDF
      in adolescents (ages 12-17) was needed to assess the safety and efficacy of this agent in the
      treatment of chronic hepatitis B in this patient population. In addition, the study will help
      to further elucidate the pharmacokinetic (PK) and resistance profiles of TDF. Through their
      participation, study participants will help generate critical new information to help guide
      the most optimal treatment of chronic HBV infection in adolescents.

      This is a randomized, double-blind study to evaluate the antiviral efficacy, safety, and
      tolerability of TDF versus placebo in adolescents with chronic HBV infection. TDF
      treatment-naive participants were randomized in a 1:1 ratio to TDF or placebo. After 72 weeks
      of blinded treatment, participants were to switch to open-label TDF for an additional 2.5
      years of treatment, provided that no safety concerns are identified by the Independent Data
      Monitoring Committee monitoring the study.
    


Intervention name(s): Tenofovir disoproxil fumarate (TDF); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TDF administered as a 300-mg tablet once daily; TDF placebo tablet once daily
Other intervention name(s): Viread®
Intervention MeSH terms: Tenofovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: tenofovir; adolescents; chronic hepatitis B
Trace Elements and Heavy Metals at PPROM
Condition: Preterm Rupture of Membranes
MeSH terms: Premature Birth; Fetal Membranes, Premature Rupture; Rupture
Study type: Observational

Summary: 
      Objectives: To evaluate maternal serum trace elements and heavy metals namely, aluminum (Al),
      chromium (Cr), manganese (Mn), cobalt (Co), nickel (Ni), copper (Cu), zinc (Zn), arsenic
      (As), molybdenum (Mo), cadmium (Cd), tin (Sn), antimony (Sb), mercury (Hg), and lead (Pb) in
      pregnant women complicated by preterm prelabour rupture of the membranes (pP-ROM) and to
      compare the results with healthy pregnancies.

      Methods: Maternal serum levels of Al, Cr, Mn, Co, Ni, Cu, Zn, As, Mo, Cd, Sn, Sb, Hg, and Pb
      were measured in the study group, which included 55 pregnant women complicated with pP-ROM
      and 60 healthy pregnancies (control group) with respect to maternal age and gestational
      weeks. The maternal serum levels of trace elements and heavy metals in both groups were
      measured using an inductively coupled plasma-mass spectrometry (ICP-MS) and compared.
    

Detailed description: 
      This current observational study was conducted at Cengiz Gokcek Women's and Children's
      Hospital Gaziantep, Turkey at the Department of Obstetrics and Gynecology between dates of
      August 2018 and March 2019. The experiment was conducted according to the Declaration of
      Helsinki. All subjects included in the study gave oral and written informed consents. The
      study population consisted of 55 women with a singleton pregnancy who were diagnosed with
      pP-ROM between 24+0 and 36+6 weeks of gestation. The control cases were recruited from the
      healthy pregnant women with a gestational age-matched cohort who admitted for routine
      obstetric care to our outpatient clinic. Sixty healthy pregnant women who delivered at term
      were included in the study as the control group. All patients will gave their oral and
      written informed consent before their inclusion in the study.
    

Intervention name(s): maternal serum concentration of trace elements and heavy metals levels
Intervention type(s): Diagnostic Test
Intervention description(s): The maternal serum levels of trace elements and heavy metals in both groups were measured using an inductively coupled plasma-mass spectrometry (ICP-MS)
Intervention MeSH terms: Trace Elements; Micronutrients
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The investigators consecutively will recruite 55 subjects with preterm prelabor rupture of
        the membranes, and 60 healthy preganancies will selected for the control group.
Epidemiology of Gallbladder Sludge and Stones in Pregnancy
Condition: Cholelithiasis
MeSH terms: Cholelithiasis; Cholecystolithiasis; Gallstones
Study type: Interventional

Summary: 
      The specific objective of this project is to study the impact exercise has on gallstone
      formation during pregnancy when women are at increased risk due to biochemical and
      physiological alterations.
    

Detailed description: 
      The female gender and multiparity are the two most important positive correlates of
      cholesterol gallstone disease. Pregnancy represents the period of time when the 'lithogenic'
      pressure on a woman is the highest. Biliary sludge is a precursor stage of gallstones. The
      investigators studied the etiological factors associated with the development of sludge and
      stones during pregnancy, and their early results suggest that it is inversely related to
      physical activity. They also found that being overweight, a known risk factor for gallstone
      disease, is associated with high blood leptin levels. In addition, the risk associated with
      high leptin levels is partially mitigated by physical activity.

      In order to disentangle the effects of physical activity, leptin and gestational diabetes on
      gallbladder disease risk, and to understand the mechanisms behind the observed associations,
      the investigators propose to conduct a randomized controlled trial. This interventional study
      is a logical extension of their previous observational investigation. Their specific aims
      are:

        -  To evaluate whether an endurance exercise program is associated with lower risk of
           gallbladder disease in overweight pregnant women;

        -  To evaluate whether an endurance exercise intervention program changes leptin levels in
           pregnancy among overweight women;

        -  To examine the associations between gallbladder disease incidence and potential causal
           variables in this prospective trial. These variables include leptin levels, HDL, insulin
           levels, BMI (as it varies within women classified as overweight), as well as changes in
           these variables.

      Gallstone disease affects 15-20% of adult Americans. Cholecystectomy is one of the most
      commonly performed operations. The morbidity, and the burden of cost, incurred by gallstones
      are staggering. Yet there is a dearth of understanding in the epidemiology and the cause of
      this disease. The results of this investigation should generate new, important and useful
      insights into the pathogenesis, and provide a rational strategy for the prevention, of this
      common and costly disease.
    

Intervention name(s): Exercise
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: physical activity; cholelithiasis; pregnancy complication
Role of Functional Translation After Immersive Virtual Reality Exposure in Persons With Stroke
Condition: Hemiparesis as Late Effect of Cerebrovascular Disease
MeSH terms: Paresis; Cerebrovascular Disorders
Study type: Interventional

Summary: 
      This is a single-blinded randomized control trial aiming to explore the use of immersive
      virtual reality (VR) training in conjunction with real-life tasks therapy in 75 first time
      stroke patients with upper limb weakness.
    

Detailed description: 
      Patients will be randomized to a control or experimental group. The experimental group will
      receive immersive VR training followed by the translation of related tasks in a real life
      environment. The control group will perform the same tasks in a real life environment but
      will receive immersive VR exposure to a non-related task.
    

Intervention name(s): Immersive virtual reality + related functional translation into real-life; Immersive virtual reality + non-related translation into real-life
Intervention type(s): Other; Other
Intervention description(s): The experimental group will perform tasks in an immersive virtual reality setting designed to encourage functional task performance for 30 minutes. The patient will then be brought to a real-life setting and evaluated on similar task performances for an additional 30 minutes for a total of 60 minutes per day, 3 times a week for 2 weeks.; The control group will also be asked to perform tasks in an immersive VR setting for 30 minutes, however tasks will be unrelated to the tasks performed in the real-life setting in the following 30 minutes. The control group will also receive 60 minutes of therapy a day, 3 times a week, for 2 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Cell Therapy In Dilated Cardiomyopathy
Condition: Dilated Cardiomyopathy
MeSH terms: Cardiomyopathies; Cardiomyopathy, Dilated
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine effect of cell therapy in patients with severe
      dilated cardiomyopathy
    

Detailed description: 
      This protocol describes a double-blind placebo controlled randomized clinical trial to
      evaluate the efficacy of bone marrow derived stem cell implants in 300 bazillion patients
      with dilated cardiomyopathy and heart failure in class III or IV of the New York Heart
      Association.

      The primary endpoint of this study is to evaluate the effect of the autologous bone marrow
      stem cell implant in the increase of the ejection fraction of the left ventricle in
      comparison with a control group, under optimized therapy for dilated cardiomyopathy.
      Secondary endpoints will evaluate the alteration in NYHA functional class, mortality rate,
      physical capacity (by ergoespirometry), life quality (Minnesota questionnaire) and pulmonary
      congestion in dilated cardiomyopathy patients the received the autologous bone-marrow stem
      cell implant.

      Hypothesis: The main hypothesis of this study is that the patients who received the
      autologous bone-marrow stem cell implant will have after a 6 month follow-up a mean 5%
      increase in absolute left ventricle ejection fraction in comparison with the control group.
    

Intervention name(s): optimal therapy for cardiaca failure; cell
Intervention type(s): Drug; Procedure
Intervention description(s): optimal therapy for cardiaca failure; stem cell
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dilated Cardiomyopathy; stem cells; Therapeutics; Randomized Controlled Trials
EMT in Peritoneal Dialysis Patients
Condition: Peritoneal Dialysis Complication
Study type: Observational

Summary: 
      Approximately 10-11% of end stage kidney disease patients worldwide utilize peritoneal
      dialysis (PD) as their method of renal replacement therapy. Over time, the peritoneal
      membrane often undergoes anatomic and functional changes due to the process of epithelial to
      mesenchymal transition (EMT). EMT is characterized by increases in pro-inflammatory and
      pro-angiogenic cytokines. In this process, the mesothelial cells lining the peritoneal
      membrane are denuded and change their morphology to one more closely resembling fibroblasts.
      These fibroblasts invade the submesothelial zone of the peritoneal membrane resulting in
      marked fibrosis, and the pro-angiogenic cytokines cause an increase in neovascularization.
      Jointly, these processes culminate in impaired function of the peritoneal membrane and often
      limit the duration of effective PD therapy.

      In vitro studies in cultured human peritoneal mesothelial cells (HPMCs) and in vivo studies
      in rodent models of PD have demonstrated that the use of active Vitamin D receptor agonists
      or statins may attenuate this process of EMT. These are both classes of drugs that are
      commonly in use by patients on PD. The investigators goal is to determine whether either or
      both of these drugs might attenuate the process of EMT in patients performing PD.
    

Detailed description: 
      Patients will perform a standard 2 Liter overnight dwell with the usual 2.5% dextrose PD
      solution. This will be done the night before a routinely scheduled visit to the home dialysis
      clinic. In the clinic the fluid will be drained in usual fashion and the fluid- which would
      otherwise be discarded- will be analyzed as below:

      HPMCs will be isolated as previously described by Kinashi et al. and stored at -80 degrees
      until analysis. Changes in the protein expression of EMT markers such as E-cadherin, alpha
      smooth muscle actin (a-SMA), Snail, and fibronectin in the HPMCs will be evaluated by Western
      blot analysis.
    

Intervention name(s): Isolation of peritoneal mesothelial cells
Intervention type(s): Diagnostic Test
Intervention description(s): HPMCs will be isolated and stored at -80 degrees until analysis. Changes in the protein expression of EMT markers such as E-cadherin, a- SMA, Snail, and fibronectin in the HPMCs will be evaluated by Western blot analysis.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        PD patients > 18 years old. We propose to study 4 groups of 6 patients each:

          1. Patients taking neither an active Vitamin D analogue nor a statin

          2. Patients already taking an active Vitamin D analogue

          3. Patients already taking a statin

          4. Patients already taking both an active Vitamin D analogue and a statin
      
Biospecimen description: 
      Isolated human peritoneal mesothelial cells
Study in Healthy Adult Male Participants to Gather Information How the Human Body Absorbs, Distributes and Excretes the Study Drug Selitrectinib Including the Effect of the Interaction of Food With the Study Drug on the Human Body
Condition: Solid Tumors Harboring NTRK Fusion
Study type: Interventional
Phase: Phase 1

Summary: 
      The researchers in this study want to gather information in healthy adult male participants
      about how the human body absorbs, distributes and excretes the drug selitrectinib including
      the effect of the interaction of food with the study drug on the human body. Selitrectinib is
      a new drug under development for the treatment of patients with solid tumor caused by a
      genetic abnormality known as an NTRK gene fusion which cannot be cured by currently available
      treatment options or has spread to other parts of the body. The drug blocks the action of the
      NTRK gene fusion and prevents the activation of certain proteins (TRK fusion proteins), which
      can cause cancer cells to multiply and form a tumor. Researchers also want to find out if the
      participants have any medical problems during this study.

      Participants in this study will receive the study drug twice with at least 6 days in between.
      The study drug will be taken orally as a liquid before or after meal. Observation will last
      for up to 8 weeks, and blood samples will be taken from the participants to measure the blood
      levels of the study drug.
    

Detailed description: 
      The primary objectives of this study are to investigate the pharmacokinetics and the effect
      of food on the pharmacokinetics of selitrectinib after a single dose of the drug.

      Secondary objective is to assess the safety of selitrectinib after a single dose.
    

Intervention name(s): Selitrectinib (BAY2731954)
Intervention type(s): Drug
Intervention description(s): Selitrectinib is administered orally as liquid suspension (20 mg/mL) on Day 1 of each period. Each period lasts 4 days, both periods of each arm are separated by at least 3 days.
Other intervention name(s): Tyrosine receptor kinase (TRK) inhibitor
Intervention MeSH terms: Selitrectinib
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy volunteers; Pharmacokinetics; Food-Drug Interactions; Advanced or metastatic solid tumors; Neurotrophic tyrosine receptor kinase (NTRK) gene fusion; Tyrosine receptor kinase (TRK); TRK inhibitor; Drug formulation; Liquid suspension
Role of Two Rehabilitative Treatments and Diet in the Modulation of Inflammation in Patients With Knee Prosthesis.
Condition: Knee Pain Swelling
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      The investigators studied the influence of two aproved rehabilitative treatments, connective
      tissue techniques and lymphatic drainage, on acute inflammation markers. Furthermore, the
      role of mediterranean diet on the same values was investigated in the first postoperative
      period
    

Detailed description: 
      The main objective of this study is to demonstrate the effectiveness of lymphatic drainage
      and connective tissue techniques in modulating systemic inflammation. Another objective is to
      evaluate the existence, at baseline, of a correlation between the inflammation indices and
      the level of adherence to the Mediterranean diet.

      Methods. 34 patients were recruited, and divided into three groups. The control group
      followed the normal rehabilitation protocol. The other two groups were subjected, in addition
      to the standard treatment, to manual lymphatic drainage treatment or connective tissue
      techniques. The outcomes (PCR, ESR, Oedema) were recorded in three stages: upon entering the
      hospital, 1 week after entry and at follow-up 21 days after surgery.
    

Intervention name(s): Lymphatic drainage
Intervention type(s): Procedure
Intervention description(s): The interventions follow the validated techniques normally used in international rehabilitation
Other intervention name(s): Connective tissue massage
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Trial
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: total Knee Arthroplasty (TKA); C-reactive protein (CRP); erythrosedimentation rate (ESR); Over Knee Oedema (EDO); Under Knee Oedema (EDU); MEDIET Questionnaire
Caplacizumab Single and Multiple Dose Study in Healthy Japanese and White Subjects.
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary objective:

      To assess the safety and tolerability of single ascending intravenous (i.v.) doses, a single
      subcutaneous (s.c.) dose of caplacizumab (Part I), and multiple s.c. doses of caplacizumab
      (Part II) in Japanese subjects.

      Secondary objectives:

        -  To compare the pharmacokinetic (PK) and pharmacodynamic (PD) profiles (total vWF:Ag
           concentration levels [vWF:Ag], coagulation factor VIII [FVIII:C], and ristocetin
           cofactor activity [RICO]) after single i.v. or s.c. administration of caplacizumab in
           Japanese and White subjects.

        -  To evaluate the immunogenicity of caplacizumab (anti-drug antibodies [ADA]) in Japanese
           subjects.
    


Intervention name(s): Caplacizumab Dose 1 iv (single-dose); Caplacizumab Dose 2 iv (single-dose); Caplacizumab Dose 2 sc (single-dose); Caplacizumab Dose 2 sc (multiple-dose); Placebo iv (single-dose); Placebo sc (single-dose); Placebo sc (multiple-dose)
Intervention type(s): Biological; Biological; Biological; Biological; Other; Other; Other
Intervention description(s): Single intravenous (iv) administration of Caplacizumab Dose 1; Single intravenous (iv) administration of Caplacizumab Dose 2; Single subcutaneous (sc) administration of Caplacizumab Dose 2; Once daily subcutaneous (sc) administration of Caplacizumab Dose 2 during 7 consecutive days; Single intravenous (iv) administration of Placebo; Single subcutaneous (sc) administration of Placebo; Once daily subcutaneous (sc) administration of Placebo during 7 consecutive days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Phase 2, Randomized, Open-Label, Crossover, PD/PK Study of a Novel Pram-Insulin Co-Formulation in Adults With T1D
Condition: Diabetes Mellitus, Type 1; Insulin-dependent Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, open-label, active-controlled, single-dose, 3-treatment, 3-period,
      3-way crossover, comparative PD and PK inpatient study in adults with T1D. The study
      comprises 5 visits: Screening (Visit 1), Treatment Periods (Visits 2 - 4), and Follow-Up
      (Visit 5).
    


Intervention name(s): PRAM9; Regular Insulin + Pramlintide; Regular Insulin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): SC injection; Separate SC injections; SC injection
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Pramlintide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment