bioihbjkbjnl/mcl2 huggingface dataset:
PK TDF in Thai HIV-infected Children
Condition: HIV
Study type: Interventional

Summary: 
      This study will assess the pharmacokinetics of TDF in Thai HIV-infected children
    

Detailed description: 
      HIV-infected children who are currently on TDF-base once daily regimen will be enrolled into
      this study. PK visit will be performed at least 1 month after changing regimen to once daily
      regimen. Adherence 3 days before PK study will be confirmed using adherence questionnaire.
      100% of adherence is needed for PK study. If there is adherence problem on PK visit, PK study
      will be deferred to at least 3 days. On PK visit, blood drawn will be performed at 0, 2, 4,
      6, 8, 10, 12, 24 hr. after taking ARVs for PK study. Blood drawn for safety evaluation will
      be drawn at any time-point on the PK visit. There is no study drug in this study. All ARVs
      that patient taking will be according to patient's requirement, and physician judgment. ARVs
      dosage will follow the Thai national pediatric guideline. CBC, CD4, viral RNA, viral
      resistance, ALT, cholesterol, and triglyceride results can be from other visits within 4
      weeks window period.

      Statistical considerations Sample size calculations. There are no pharmacokinetic data in
      children. In adults, the mean (SD) AUC following administration of a 300mg Viread tablet in
      fasting state is 2.29 (0.69) microg.hr/mL. In patients taking lopinavir/ritonavir and
      atazanavir/ritonavir, the mean AUC of TDF is increased by 32% and 24% respectively. Efavirenz
      does not change the AUC of TDF. If the weight adjusted dose of TDF in children and
      adolescents achieves the same AUC as in adults and concomitant dosing with a protease
      inhibitor increases the TDF AUC by 30% but concomitant dosing with Efavirenz does not change
      the TDF AUC, then 20 treated with Efavirenz and 20 patients treated on a PI based regimen
      would provide 90% power to detect this difference at the 5% significance level.

      Statistical Analysis.

      Primary endpoints Pharmacokinetic parameters will be calculated based on individual plasma
      concentration vs time data, using noncompartmental methods. Data will be summarized overall
      and by whether the patient is taking a PI or an EFV-based regimen. Formal statistical
      comparisons of parameters will be made using ANOVA techniques or non-parametric equivalents
      as appropriate. Effect sizes and 95% confidence intervals will be given for all comparisons.
    

Intervention name(s): TDF (Tenofovir); Efavirenz; lopinavir/ritonavir, atazanavir/ritonavir
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Ritonavir; Lopinavir; Atazanavir Sulfate; Tenofovir; Efavirenz
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: pharmacokinetics; TDF; HIV-infected children; Thai; non-nucleoside reverse transcriptase inhibitor (NNRTI); ritonavir-boosted protease inhibitor (bPI); less than eighteen years old
Strategies for Preventing Falls in the Elderly
Condition: Fall; Elderly; Prevention; Telehealth; Physical Therapy
Study type: Interventional

Summary: 
      Fall incidents are the third cause of chronic disability in the elderly, according to the
      World Health Organization (WHO). Recent reviews demonstrate that multifactorial and
      multicomponent intervention programs are effective in preventing falls in community-dwelling
      older adults. However, the application of these programs may not be accessible to a large
      part of the elderly population. The lack of continuity in the treatment of the consequences
      of falls, as well as the dissemination of prevention measures for this patient profile, could
      be minimized through the use of information and communication technologies. Method: This will
      be a randomized clinical trial that aims to evaluate the effects of two fall prevention
      strategies via telerehabilitation for elderly fallers after admission to an emergency room.
      It will be carried out by a multidisciplinary team with interventions for eight weeks and
      monitoring of outcomes over a period of four months. Patients will be evaluated regarding
      aspects of functionality in the second and month after the interventions and regarding the
      recurrence of falls during the four-month period. Discussion: The hypothesis is that the
      programs are viable in terms of accessibility to home training. However, to date, there is no
      evidence about the differences between these forms of interventions to prevent falls via
      telecare.
    

Detailed description: 
      To compare the effects of two different strategies for preventing falls through
      telerehabilitation for elderly fallers after admission to an emergency room.
    

Intervention name(s): real-time intervention
Intervention type(s): Other
Intervention description(s): An individual exercise program will be carried out at home, supervised remotely via videoconference.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Research Study Looking Into Blood Levels of Three Different Formulations of the Study Medicine Ziltivekimab
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      A research study to investigate how quickly and to what extent different compositions of the
      study medicine ziltivekimab are absorbed, transported, and eliminated from the body.
      Ziltivekimab is not yet approved for market. The study medicine will be injected under the
      skin (this is called subcutaneous administration). Two different administration methods will
      be compared: a syringe and a pen-injector. A pen-injector is a device that is developed to
      make injections more easy and convenient. They are for example used by diabetes patients to
      inject insulin. It will also be investigated how safe ziltivekimab is and how well it is
      tolerated when it is used by healthy participants. Ziltivekimab has already been administered
      to patients with chronic kidney disease or rheumatoid arthritis. The current study will be
      the first study where ziltivekimab will be given to healthy participants.
    


Intervention name(s): Ziltivekimab B; Ziltivekimab D; Ziltivekimab C
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive a single s.c. injection of 15 mg ziltivekimab B (15 mg/mL) by single-use pre-filled manual syringe on Day 1.; Participants will receive a single s.c. injection of 15 mg ziltivekimab D (15 mg/mL) by single-use pre-filled manual syringe on Day 1.; Participants will receive a single s.c. injection of 15 mg ziltivekimab C (30 mg/mL) by single-use pre-filled syringe assembled into a shield-activated pen-injector on Day 1.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
First in Human Study of ORG-129 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The current study is performed to characterize the safety, tolerability and pharmacokinetics
      of ORG-129 after oral intake in healthy male and female volunteers after single ascending and
      multiple ascending doses.
    


Intervention name(s): ORG-129; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ORG-129 oral capsules; Placebo oral capsules
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Clinical Evaluation of the SEQureDx T21 Test In High Risk Pregnancies
Condition: Down Syndrome; Fetal Aneuploidy
MeSH terms: Down Syndrome; Aneuploidy
Study type: Observational

Summary: 
      Whole blood samples will be collected from high-risk pregnant women to validate the clinical
      performance of the SEQureDx Trisomy 21 Test.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women between 10 and 22 weeks of gestation inclusive who have one or more high
        risk indicators for fetal chromosome 21 aneuploidy.
      
Biospecimen description: 
      Whole blood specimens will be collected and processed to plasma. DNA will be extracted from
      the plasma.
    
Keywords: Down syndrome; fetal aneuploidy; trisomy; noninvasive prenatal test
The Effects of Antibiotic Combinations on Stem Cells
Condition: Stem Cells; Anti-Bacterial Agents
Study type: Observational

Summary: 
      The purpose of this study was to evaluate the indirect effects of antibiotic combinations.
      SCAP viability, proliferation and apoptosis of the cells were evaluated. Osteocalcin (BGLAP),
      dentin sialo phosphoprotein (DSPP) and alkaline phosphatase (ALPP) gene expression levels
      were also evaluated.
    

Detailed description: 
      The purpose of this study was to evaluate the indirect effects of triple (TAP- ciprofloxacin,
      metronidazole and minocycline), double (DAP- ciprofloxacin and metronidazole) and modified
      triple antibiotic pastes (mTAP- ciprofloxacin, metronidazole and cefaclor) on mesenchmal stem
      cells derived from apical papilla (SCAP). SCAP were isolated from the impacted third molar
      teeth of the young adults. TAP, DAP and mTAP treatment (14-day medication and 28-day
      medication) were applied on SCAP and viability, proliferation and apoptosis of the cells were
      evaluated after four weeks. Osteocalcin (BGLAP), dentin sialo phosphoprotein (DSPP) and
      alkaline phosphatase (ALPP) gene expression levels were also evaluated.
    

Intervention name(s): Differentiation Markers
Intervention type(s): Drug
Intervention description(s): Osteocalcin (BGLAP), dentin sialo phosphoprotein (DSPP) and alkaline phosphatase (ALPP) gene expression levels were also evaluated.
Other intervention name(s): Gene expression levels
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Tissue samples were obtained from the apex of the extracted third molar teeth of young
        adult patients aged between 16-22 .
      
Biospecimen description: 
      Tissue samples were obtained from the apex of the extracted third molar teeth of young adult
      patients aged between 16-22 (N=7).
Probiotics and Health-related Quality of Life in Individuals With Seasonal Allergies
Condition: Healthy
MeSH terms: Rhinitis, Allergic, Seasonal; Hypersensitivity
Study type: Interventional

Summary: 
      In this randomized, double-blind, placebo-controlled study, participants with seasonal
      allergies will receive a daily probiotic or placebo for 8 weeks. Questionnaires will assess
      health-related quality of life, stress, physical activity, gastrointestinal symptoms, adverse
      events, and compliance. In a subset of subjects, stool and blood samples will be collected at
      baseline and at week 6 of the intervention (estimated to be peak allergy season) to
      characterize microbial communities and immune function.
    


Intervention name(s): Probiotic mixture; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): A 350 mg capsule containing a mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) will be taken twice daily for 8 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded). Inactive ingredients include gelatin, potato starch, and silica.; Placebo will be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded). Supplement contains 348.25 mg of potato starch.
Other intervention name(s): Kyo-Dophilus; Lactobacillus gasseri KS-13; Bifidobacterium bifidum G9-1; Bifidobacterium longum MM-2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: probiotic; allergy; immune
Testosterone for HIV-Positive Men With Reduced Serum Testosterone Levels and Abdominal Fat
Condition: HIV Infections
MeSH terms: HIV Infections; HIV Seropositivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to see if treatment with testosterone will reduce abdominal fat
      in HIV-positive men.

      Many HIV patients on antiretroviral therapy show an increase in abdominal fat. Studies have
      shown that treatment with testosterone may decrease abdominal fat. This study will determine
      if testosterone will reduce abdominal fat in HIV patients.
    

Detailed description: 
      Reports suggest that many HIV-infected patients on antiretroviral therapy experience an
      increase in abdominal fat. The mechanisms of abdominal fat accumulation in HIV-infected
      patients are not known. Studies have shown: treatment with testosterone gel reduces total
      body fat in young, androgen-deficient men; testosterone replacement in middle-aged men with
      mid-segment obesity decreases visceral fat; and replacement doses of testosterone decrease
      fat mass and augment lean body mass in HIV-infected men with androgen deficiency. Therefore,
      there is a strong rationale for evaluating the effectiveness of testosterone replacement in
      HIV-infected men with visceral obesity and low testosterone levels.

      Patients are stratified based on their viral load. Patients receive either testosterone gel
      or placebo applied to the skin once daily for 24 weeks. Patients remain on their current
      antiretroviral regimens, which are not supplied through the study. Patients who receive
      testosterone during the first 24 weeks are eligible to receive it for an additional 24 weeks.
      Patients on placebo are followed for an additional 24 weeks. Clinical and laboratory
      evaluations for visceral fat changes are performed throughout the study.
    

Intervention name(s): Testosterone
Intervention type(s): Drug
Intervention MeSH terms: Testosterone
Masking: Double
Primary purpose: Treatment
Keywords: Testosterone; Anthropometry; Obesity; Abdomen
Cognitive Training for Nicotine Dependence
Condition: Tobacco Use Disorder; Nicotine Addiction
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      This randomized clinical trial tested the effects of a computerized (web-based) cognitive
      training intervention on smoking cessation.

      All participants received 8 weeks of standard nicotine patch therapy, smoking cessation
      counseling, and were randomized to 1 of 2 different training programs: cognitive training vs.
      control training.
    


Intervention name(s): Cognitive Training; Control training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The computerized cognitive training intervention is a 12-week standardized course of internet-based computerized cognitive exercises designed to enhance executive cognitive function.; The computerized control training intervention is a 12-week standardized course of internet-based deep breathing exercises which does not contain the cognitive exercises designed to enhance executive cognitive function.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Tobacco; Smoking; Cognition; Behavioral Training; Relapse
Perioperative Virtual Reality for Pediatric Anesthesia
Condition: Anxiety
Study type: Interventional

Summary: 
      The goal of this study is to evaluate the use of immersive audiovisual distraction and
      virtual reality to reduce perioperative anxiety in pediatric patients undergoing surgery at
      UCSF Benioff Children's Hospital. The study plans to employ virtual reality headsets during
      induction of anesthesia in pediatric patients for elective surgery in a randomized clinical
      trial.
    

Detailed description: 
      The goal of this study is to evaluate the use of immersive audiovisual distraction and
      virtual reality to reduce perioperative anxiety in pediatric patients undergoing surgery at
      UCSF Benioff Children's Hospital. The study plans to employ virtual reality headsets during
      induction of anesthesia in pediatric patients for elective surgery in a randomized clinical
      trial. We will be enrolling patients age 5-12 years presenting for elective surgery.

      Patients will be randomized to one of two groups: (1) virtual reality headset with routine
      anesthetic care and (2) routine anesthetic care only.
    

Intervention name(s): Perioperative virtual reality headset with mobile app
Intervention type(s): Device
Intervention description(s): Perioperative virtual reality headset with mobile app (Samsung Gear VR headset, ChariotVR software)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Virtual Reality; Pediatric Anesthesia
Pivotal Study (Pharmacokinetics, Efficacy, Safety) of BAX 326 (rFIX) in Hemophilia B Patients
Condition: Hemophilia B
MeSH terms: Hemophilia A; Hemophilia B
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this pivotal Phase 1/3 study is to determine the pharmacokinetic (PK)
      parameters, the hemostatic efficacy, and the safety of BAX 326, a recombinant factor IX, in
      previously treated patients (PTPs) with severe and moderately severe hemophilia B.
    


Intervention name(s): BAX 326; BeneFIX
Intervention type(s): Biological; Biological
Intervention description(s): Study Part 1: Pharmacokinetic (PK) Crossover with BAX326 and BeneFIX
Study Part 2: Open-label evaluation of prophylaxis and on-demand BAX326 only
Study Part 3: Open-label repeat of PK evaluation (repeat Study Part 1) with BAX326 only and same study participants as Study Part 1; Study Part 1: Pharmacokinetic (PK) Crossover with BAX326 and BeneFIX.
BeneFIX only used in Part 1 of this study.
Study Part 2 and 3 only utilized BAX326
Other intervention name(s): Recombinant factor IX (rFIX); RIXUBIS; Recombinant factor IX (rFIX)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Intermittent Ropivacaine Bolus for Epidural Labor Analgesia
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Observational

Summary: 
      Enhanced patient safety and satisfaction have contributed to growing use of epidural labor
      analgesia. Epidural analgesia appears to be currently the most effective technique in
      reducing pain during labor. However, reduction in total dose of local anesthetic and thus
      motor blockade is crucial to improve the obstetric outcome. This technique has evolved from
      intermittent boluses by anesthesiologists to the current standard labor epidural analgesic
      regimens in many institutions in North America and Europe that consist of a local anesthetic
      in combination with an opioid delivered via continuous epidural infusion (CEI) with or
      without patient-controlled epidural analgesia (PCEA) boluses. Recently,a new mode of
      administration has been used: regular bolus of low concentration local anesthetic +
      intermittent bolus (PIEB). This technique would offer safe and superior quality labor
      analgesia and greater maternal satisfaction by reducing total amount of the drug combination.

      The primary outcome was to evaluate the analgesic efficacy of PIEB epidural drug delivery in
      terms of visual analogue scale satisfaction (VAS) score in a large cohort of patients. The
      secondary outcomes were to measure the degree of motor blockade, neonatal and obstetric
      outcomes, total drug dose and incidence of pain that required top-up administration
      (breakthrough pain)
    

Detailed description: 
      Patients were explained about the procedure and written informed consent was obtained.
      Healthy term primi or second gravid parturients (aged >18 years) with a singleton, live fetus
      in vertex presentation when in active stage of labor with cervical dilation of 3-5 cm were
      recruited in the study after they requested epidural for pain relief. PIEB epidural analgesia
      was used.

      Primary outcome was maternal satisfaction during labor and delivery. Our hypothesis was that
      patients would have a greater level of satisfaction when using PIEB technique. The secondary
      outcomes were to measure the degree of motor blockade, neonatal and obstetric outcomes.
    

Intervention name(s): Ropivacaine
Intervention type(s): Drug
Intervention description(s): Epidural : automatic intermittent boluses associated with patient controlled bolus using ropivacaine
Other intervention name(s): ropivacaine 2 mg/ml
Intervention MeSH terms: Ropivacaine
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        healthy term primi or second gravid parturients aged 18-30 years with a singleton, live
        fetus in vertex presentation when in active stage of labor with cervical dilation of 3-5 cm
      
Keywords: Pregnant; Labor; Epidural; Analgesia; Intermittent
Fall Risk Assessment in People With Diabetic Neuropathy
Condition: Diabetic Peripheral Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Study type: Observational

Summary: 
      Fall risk is increased in people with diabetic peripheral neuropathy (DPN) and yet, minimal
      research has been conducted to identify appropriate fall risk assessment tools and improve
      our understanding of falls in these individuals. Purpose: The primary purpose of this study
      is to establish a foundation of knowledge needed to address falls in people with DPN. This
      will be accomplished through 1) comparing the validity of 4 fall risk assessment tools, 2)
      identifying risk factors for falls and 3) determining how quality of life is influenced by
      factors related to falls in people with DPN.
    

Detailed description: 
      All subjects participate in testing that involves questionnaires, cognitive testing, fall
      risk assessment, and other testing related to physical parameters including body mass index,
      glycosylated hemoglobin, lower extremity nerve conduction study, and ankle range of motion,
      proprioception and strength. After testing, subjects are interviewed to determine fall status
      (faller or non-faller). A "faller" is defined as someone that has fallen at least 2 times in
      the past year. Data Analysis: The validity of the fall risk assessment tools will be compared
      using sensitivity and specificity analyses. Variables related to ankle function, neuropathy,
      glycemic control and general activity will be analyzed for association with recent fall
      history through multivariable logistic regression. Variables related to falls, neuropathy and
      activity level will be analyzed for association with health-related quality of life through
      multivariable linear regression.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Persons that have diabetic peripheral neuropathy
      
Keywords: neuropathy; diabetes