bioihbjkbjnl/mcl2 huggingface dataset:
Drug Interaction Study Between Antimalarial and Anti-HIV Medications
Condition: HIV Infections; Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to find out whether taking certain anti-HIV medicines with
      certain antimalarial medicines affects the amount of the medicines in the blood.

      The study medicines that will be used are artemether/lumefantrine (antimalarial medication)
      and lopinavir/ritonavir or efavirenz (anti-HIV medications). Artemether/lumefantrine is not
      approved by the United States Food and Drug Administration (FDA) but is recommended as
      standard of care medical treatment for malaria in Africa and Asia. Lopinavir/ritonavir and
      efavirenz are approved by the FDA. Artemether/lumefantrine and lopinavir/ritonavir or
      efavirenz may need to be used together to treat children in Africa and Asia. We seek to learn
      about whether or not the use of these medicines together results in a change in blood levels
      of any of these medicines. The information obtained from this study will help doctors to
      provide a better treatment to children and adults with malaria and HIV.
    

Detailed description: 
      The study involves 5 non-consecutive overnight stays and 14 additional outpatient visits at
      the San Francisco General Hospital Research Center.
    

Intervention name(s): Lopinavir/Ritonavir, Efavirenz, Artemether/lumefantrine
Intervention type(s): Drug
Intervention description(s): participants receive a total of 6 doses of artemether(80mg)/lumefantrine(480mg)for baseline PK evaluation. This is followed by a 26-day course of either efavirenz(600mg) once daily or lopinavir/ritonavir (400mg/100mg) twice daily and additional 6 doses of artemether/lumefantrine to determine the pharmacokinetics of the antimalarial medications in the context of antiretrovirals. The participants undergo at least a 14 day washout period (between the last baseline PK blood draw and the initiation of antiretrovirals)
Intervention MeSH terms: Ritonavir; Lopinavir; Efavirenz; Lumefantrine; Artemether; Artemether, Lumefantrine Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: healthy; controls; research; clinical; study; pharmacokinetic; PK; HIV; malaria
A Proof-of-Concept Trial of GLA-SE in Patients With Merkel Cell Carcinoma
Condition: Merkel Cell Carcinoma
MeSH terms: Carcinoma, Merkel Cell; Carcinoma
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single arm, open-label, single center study evaluating the safety, feasibility,
      clinical efficacy and immunogenicity of GLA-SE administration to patients with Merkel cell
      carcinoma. Ten patients will be treated. The goal is for GLA-SE to assist the patient's own
      immune system in attacking the cancer cells.
    

Detailed description: 
      This is a single arm, open-label, single center study evaluating the safety, feasibility,
      clinical efficacy and immunogenicity of GLA-SE administration to patients with Merkel cell
      carcinoma. Ten patients with metastatic or locoregional disease will be treated. The goal is
      for GLA-SE to assist the patient's own immune system in attacking the cancer cells.
    

Intervention name(s): GLA-SE
Intervention type(s): Biological
Intervention description(s): Glucopyranosyl Lipid A in Stable Emulsion
Other intervention name(s): Glucopyranosyl Lipid A in Stable Emulsion
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Merkel cell carcinoma; MCC
Use of Passive, Adaptive, and Active Prosthetic Knees in Persons With Unilateral, Transfemoral Amputation
Condition: Transfemoral Amputation
Study type: Interventional

Summary: 
      The goals of this study are to assess measured, observed, and self-reported outcomes achieved
      through the use of passive (mechanical), active(motorized) and adaptive (magnetorheological)
      prosthetic knee control systems in individuals with unilateral, transfemoral amputation.
    

Detailed description: 
      An interrupted time-series trial with pre/post baseline assessments, randomized crossover of
      interventions, and within-phase repeated measures is used to evaluate and compare the
      effectiveness of the Össur Power Knee II and the Össur Rheo Knee in individuals with
      unilateral, transfemoral amputation. A rigorous and clinically-meaningful experimental
      protocol is applied to verify study participants receive appropriate training, experience,
      and assessment in each knee condition. A suite of standardized and ad-hoc physical
      performance tests, patient-reported questionnaires, and monitoring technologies were
      carefully selected to assess important, clinically-relevant participant outcomes. Comparative
      effectiveness of three prosthetic knee interventions are evaluated using direct measurement
      (i.e., timed tests), observed clinical ratings (i.e., subjective assessments of gait quality)
      and self-report instruments (i.e., health status surveys). Analyses will focus on identifying
      differences between control system technologies inherent to each type of prosthetic knee
      (i.e., passive [mechanical], adaptive [magnetorheological], and active [power]). Outcomes
      will be used to establish recommendations for which activities and patients knees are most
      appropriate or likely to produce a desired effect.
    

Intervention name(s): Active knee (Ossur Power Knee II); Adaptive knee (Ossur Rheo); Passive knee (Various manufacturers)
Intervention type(s): Device; Device; Device
Intervention description(s): Prosthetic knee with active control system.; Prosthetic knee with adaptive control system.; Prosthetic knee with mechanical control system.
Other intervention name(s): Power knee; Motorized knee; Magnetorheological knee; Microprocessor knee; Mechanical knee; Hydraulic knee; Pneumatic knee
Intervention model: Single Group Assignment
Masking: Single (Participant)
Efficacy of STABLOR® on Visceral Fat Mass Reduction in Patients With Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      The primary objective of the study is to assess the efficacy of STABLOR® consumption on
      visceral fat mass compared to placebo, in persons with metabolic syndrome during 12 weeks of
      consumption.
    

Detailed description: 
      It is expected that the food product STABLOR will reduce visceral fat mass in subjects with
      metabolic syndrome and therefore will improve cardiometabolic risk factors. The aim of the
      current study is to assess the impact of a 12-week intake of STABLOR, compared to a placebo,
      on visceral fat in patients with metabolic syndrome. The primary objective of the study is to
      assess the efficacy of 12-week STABLOR® consumption on visceral fat mass compared to placebo,
      in persons with metabolic syndrome. The Secondary outcomes include Anthropometric
      measurements and body composition, metabolic syndrome status, STABLOR® metabolism,
      Cardiovascular biomarkers, Systemic inflammation, Quality of life and Behavior.
    

Intervention name(s): Stablor; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Stablor sachet; placebo sachet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety Study of Mini-dystrophin Gene to Treat Duchenne Muscular Dystrophy
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety of a miniature dystrophin gene in the
      treatment of progressive muscle weakness due to Duchenne Muscular Dystrophy (DMD).
    

Detailed description: 
      This phase I randomized double blind dose escalation study investigates the safety and
      efficacy of the mini-dystrophin gene transferred to the biceps muscle for Duchenne muscular
      dystrophy patients, ages 5 to 12 years of age, using a recombinant adeno-associated virus.
      Eligible participants must have a known dystrophin gene mutation and may be concurrently
      treated with corticoid steroids. The mini-dystrophin gene or a placebo agent (normal saline
      or empty viral capsids) are injected directly into both biceps muscles while under conscious
      sedation. Following the gene transfer, patients are admitted to the hospital for 48 hours of
      observation followed by weekly outpatient visits at the Columbus Children's Hospital
      Neuromuscular Clinic. A bilateral muscle biopsy is preformed following 6 weeks with long term
      follow up will consisting of bi-annual visits for the next 2 years.
    

Intervention name(s): rAAV2.5-CMV-minidystrophin (d3990)
Intervention type(s): Biological
Intervention description(s): Recombinant adeno-associated virus (AAV) carrying a truncated human dystrophin gene (mini-dystrophin) expressed from a cytomegalovirus (CMV) promoter.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Duchenne; Muscle; Muscular Dystrophy; Gene Therapy; Dystrophin; Adeno-Associated Virus; AAV
Preterm Infants: Light Effects on Health and Development
Condition: Preterm Infant Health; Preterm Infant Development
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      Preterm babies cared for in the intensive care nursery are exposed to amounts of light that
      are very different from the exposures to an unborn baby or the newborn term baby. Currently
      many nurseries try to protect premature babies from too much light. They may also try to
      create light conditions of day and night like many parent homes. Some studies have shown
      improvements in health and development of babies cared for in nurseries that try to change
      light for premature babies.
    


Intervention name(s): Cycled Light
Intervention type(s): Other
Intervention description(s): Cycled light was provided in an 11-hour-on, 11-hour-off pattern. Daylight (240-700 lux) was provided with the incubator cover folded on top of the incubator allowing light in from four sides, or with the bassinet cover off during day hours (0730-1830). With the daylight range of 240-700 lux and limited access to natural light, excessive daylight was prevented.
Continuous near darkness was provided as (5-30 lux) throughout the day except from 0630-0730 and 1830-1930, when lighting levels varied based on nursing care needs at the change of shift. Near-darkness (5-30 lux) was provided by using incubator (totally covered or with the front flap back) and bassinet covers, and dimming individual bedside light during the day (0730-1830) and night hours (1930-0630).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cycled light; preterm infants; infant neurodevelopment; infant sleep
Correlating the Osteoarthritic Knee Microenvironment to Clinical Outcome After Treatment With Regenexx®SD Treatment
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      Single-center, lab blinded to include up to 400 subjects with knee osteoarthritis. Collection
      of synovial fluid from diseased knee before and after Regenexx®SD treatment will serve as the
      experimental condition, i.e. the osteoarthritic knee.
    

Detailed description: 
      Single-center, laboratory blinded to include up to 400 subjects with knee osteoarthritis in
      unilateral or bilateral knees treated with Regenexx® SD in the osteoarthritic knee/s.Initial
      study procedures include baseline evaluation of medical history, knee history, knee
      examination, medication use, MRI, and subject-reported outcomes.

      Subjects will be enrolled within the 120 days prior to Regenexx® SD injection. A preoperative
      visit will occur at the time of enrollment. Collection of synovial fluid from the OA knee/s
      will serve as the experimental condition, i.e. the osteoarthritic knee.Each osteoarthritic
      subject will undergo withdrawal of knee joint synovial fluid for each knee being treated
      (0.3-0.5 ml) which will be analyzed by the research laboratory via multiplexed enzyme linked
      immunosorbent assay (ELISA) and dimethylmethylene blue assay (DMMB) at pre-injection (2-8
      days before Regenexx® SD treatment) and post-injection (2-8 days after Regenexx® SD).
      Documentation of osteoarthritic joint characteristics and injection procedure details will be
      recorded throughout the study.

      The unaffected knee joint will undergo no treatment, but bilateral knees may be treated.

      Components of the synovial fluid will be correlated to post-treatment clinical outcomes,
      which include patient-reported questionnaires as well as assessment of post-injection
      complications, adverse events, re-injections and surgical interventions. Patient-reported
      clinical outcomes are comprised of the IKDC Subjective Knee Evaluation, the Lower Extremity
      Function Scale, Numeric Pain Scale and a Patient Reported Percent Improvement form.
    

Intervention name(s): Regenexx SD® procedure
Intervention type(s): Biological
Intervention description(s): Correlate patient outcomes 6 months after receiving the Regenexx SD procedure with measurements of synovial fluid collected before and after procedure.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Excretion Balance of 14c-radiolabeled BIRB 796 BS in Normal Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to characterize the pharmacokinetics of 14C-radiolabeled BIRB 796 BS and its
      metabolites including excretion and mass balance of parent compound and radioactivity; to
      isolate, identify and quantify major radiolabeled metabolites of BIRB 796 in plasma, urine
      and feces
    


Intervention name(s): 14C-BIRB 796 BS
Intervention type(s): Drug
Intervention description(s): 14C-radiolabeled BIRB 796 BS
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Passive Leg Raise for Pediatric Peripheral IV Placement
Condition: Intravenous Access
Study type: Interventional

Summary: 
      The investigators wish to determine whether passive leg raise allows for easier peripheral
      vascular access in the pediatric population. The investigators hypothesize that pediatric
      anesthesiologists will have higher rates of successful intravenous catheterization in
      children where a passive leg raise is employed.
    


Intervention name(s): Passive leg raise
Intervention type(s): Procedure
Intervention description(s): A baseline vein diameter will be obtained using ultrasound by the sub-investigator. Then a nurse will raise the child's legs using a bolster while a second measurement of the child's vein diameter is recorded by the sub-investigator. The anesthesiologist will then place the IV and rate the degree of difficulty encountered.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment
The Effect of Vitamin D Statues on Endothelial Function
Condition: Cardiovascular Diseases; Vitamin D Deficiency
MeSH terms: Cardiovascular Diseases; Vitamin D Deficiency
Study type: Interventional
Phase: Early Phase 1

Summary: 
      In the United States, cardiovascular disease causes over one-third of all deaths and vitamin
      D deficiency is an epidemic. An increasing body of data suggests that low vitamin D status
      adversely impacts the cardiovascular system. It is our fundamental hypothesis that vitamin D
      deficiency is a risk factor for cardiovascular disease by causing endothelial dysfunction.
      Moreover, we hypothesize that vitamin D supplementation will restore endothelial function,
      thereby reducing cardiovascular disease risk.

      This pilot research will be conducted in 64 post-menopausal women participating in an
      existing study of vitamin D supplementation (32 will receive vitamin D3 2,500 IU daily, the
      others matching placebo) and will explore the effects of vitamin D on endothelial function
      and arterial reactivity. Post-menopausal women aged 55-65 years are chosen due to their
      highest risk for development of a subsequent new cardiovascular disease diagnosis. All study
      participants will have fasting laboratory and noninvasive vascular ultrasound studies
      performed at baseline and four months later. The primary outcome measure of this pilot study
      is change in markers of endothelial function and arterial stiffness with vitamin D3 therapy.
      If our hypotheses are correct, our long-term goals include investigation of the effect of
      vitamin D repletion on subclinical atherosclerosis and subsequent cardiovascular events.
    


Intervention name(s): Vitamin D3; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2500 IU Vitamin D3; No (0 IU) vitamin D3 added to cookie.
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Endothelial Function; Arterial stiffness; Vitamin D
Immunogenicity of One Dose of Gardasil and One Dose of Gardasil-9
Condition: Human Papillomavirus Vaccines
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will assess the immunogenicity of one dose of Gardasil and one dose of Gardasil-9
    

Detailed description: 
      This is a one group exploratory study.

      The main objective of this study is to assess the persistance of anti-HPV after a single dose
      Gardasil and the effect of one dose of Gardasil-9 when administered 3-8 years later.
    

Intervention name(s): Gardasil and Gardasil-9
Intervention type(s): Biological
Intervention description(s): All subjects will receive one dose of Gardasil-9. Blodd samples for serological testing will be collected just before and one month post Gardasil-9 administration.
Intervention model: Single Group Assignment
Intervention model description: Single group exploratory study
Masking: None (Open Label)
Primary purpose: Prevention
Atrial Natriuretic Peptide in Assessing Fluid Status
Condition: Fluid Overload; Fluid Loss; Volume Overload; Cardiac Disease; Cardiac Output, Low; Cardiac Output, High
MeSH terms: Heart Diseases; Cardiac Output, Low; Cardiac Output, High
Study type: Interventional

Summary: 
      Biomarkers can play a significant role in fluid status assessment intraoperatively.
    

Detailed description: 
      Routinely intraoperatively the fluid status assessment is based on central venous pressure
      and other parameters. Nevertheless, the minority of anesthesiologists use continous dynamic
      parameters like pulse pressure variation, stroke volume variation and other to manage fluid
      status. There's a fast acting biomarker that can help anesthesiologist to diagnose and manage
      the volemic status and possibly guide the infusion therapy better.

      Pro-ANP is a biomarker that reacts on atria strain and can be used in volemic status
      assessment in cardiac surgery patients.
    

Intervention name(s): pro-ANP
Intervention type(s): Diagnostic Test
Intervention description(s): pro-ANP samples and fluid status assessment with functional tests (Teboul test) will be used 8 times intraoperatively.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: fluid responsiveness; fluid status; cardiac surgery; volemic status; pro-ANP; hemodynamic monitoring; functional test; teboul test; stroke volume variation; cardiac output
Investigation of the Efficacy and Tolerability of a Cosmetic Product With Onabotulinumtoxin A in the Treatment of Facial Lines
Condition: Wrinkles; Photoaging; Fine Lines
Study type: Interventional

Summary: 
      This randomized, multi-center, double-blinded, placebo-controlled, split-face clinical trial
      was conducted to evaluate the procedure-pairing of OnabotulinumtoxinA with a peptide
      anti-aging serum to improve facial lines and wrinkles, as well as overall skin texture and
      radiance of the face after 12 weeks of twice-daily use in female subjects ages 35 - 60 as
      compared to placebo. A total of 29 subjects completed study participation.
    

Detailed description: 
      This randomized, multi-center, double-blinded, placebo-controlled, split-face clinical trial
      was conducted to evaluate procedure pairing of a peptide anti-aging serum with
      Onabotulinumtoxin A in the treatment of periorbital facial wrinkles when used over the course
      of 12 weeks by women with moderate to severe crow's feet wrinkles and fine lines, and mild to
      moderate photoaging.

      Efficacy and tolerability will be assessed through clinical grading at baseline, weeks 4, 8
      and 12. Efficacy evaluation for wrinkles, fine lines, and skin appearance will be graded at
      rest and at maximum smile for each side. Investigator and subject tolerability,
      self-assessment questionnaire and VISIA photography will be completed at baseline, weeks 4, 8
      and 12.

      A total of 29 subjects completed study participation.
    

Intervention name(s): Onabotulinumtoxin A; Facial Cleanser; Facial Moisturizer; Sunscreen
Intervention type(s): Procedure; Combination Product; Combination Product; Combination Product
Intervention description(s): Subjects will receive 20 - 24 units to the crows feet (10 - 12 units per side); Facial Cleanser to be used by participants twice daily; Bland moisturizer to be used by study participants after serum twice daily.; Bland Sunscreen to be used by study participants after serum and moisturizer in the morning. Sunscreen to be reapplied if continuous sun exposure occurs.
Other intervention name(s): Botulinum Toxin, Allergan; Aveeno Face Milk SPF 40+
Intervention MeSH terms: Sunscreening Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, Multi-Center, Double-Blinded, Placebo-Controlled, Split-Face
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: anti-aging; serum; onabotulinum toxin A; Botox