bioihbjkbjnl/mcl2 huggingface dataset:
A Multicenter Trial To Evaluate Oral Retrovir in the Treatment of Children With Symptomatic HIV Infection
Condition: HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the safety and tolerance of oral zidovudine (AZT) when given over a period of 24
      weeks to children between 3 months and 12 years of age. The effectiveness of AZT in treating
      HIV infection in infants and children will also be evaluated.

      HIV infection in children is most often associated with symptomatic disease and poor
      prognosis. Treatment with antiviral therapy may be effective in altering the course of the
      disease and decreasing mortality in these children. AZT has been shown to be effective in
      certain adult patients with symptomatic HIV infection. It is therefore likely that infected
      children may also benefit from this treatment.
    

Detailed description: 
      HIV infection in children is most often associated with symptomatic disease and poor
      prognosis. Treatment with antiviral therapy may be effective in altering the course of the
      disease and decreasing mortality in these children. AZT has been shown to be effective in
      certain adult patients with symptomatic HIV infection. It is therefore likely that infected
      children may also benefit from this treatment.

      The participants receive AZT mixed with juice at a dose dependent on body size every 6 hours
      for 24 weeks. The children are evaluated weekly for the first 4 weeks, every two weeks for
      the subsequent 8 weeks, and monthly thereafter. Blood samples are collected periodically and
      cerebrospinal fluid (CSF) by lumbar puncture on 2 occasions.
    

Intervention name(s): Zidovudine
Intervention type(s): Drug
Intervention MeSH terms: Zidovudine
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug Evaluation; Administration, Oral; Acquired Immunodeficiency Syndrome; Zidovudine
Safety of ADSTEM Injection in Patients With Moderate to Severe Subacute and Chronic Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Observational

Summary: 
      This study aims to evaluate safety in subjects with over moderately subacute and chronic
      atopic dermatitis after an intravenous injection of ADSTEM Inj. Since this is an
      observational study of patients participated in Phase 1 clinical trials, no drug is
      administered in this study.
    

Detailed description: 
      Participants will be followed-up for adverse events on each visit. Visits will be on 6, 12,
      18, 24, 30, 36, 48, 60months after treatment of ADSTEM Inj.

      Time perspective is both retrospective and prospective.
    

Intervention name(s): ADSTEM Inj.
Intervention type(s): Drug
Intervention description(s): ADSTEM Inj. 1.0x10^8 mesenchymal stem cells as an intravenous infusion once in Phase I clinical trial.
ADSTEM Inj. 3.0x10^8 mesenchymal stem cells as an intravenous infusion once in Phase I clinical trial.
Observational model: Case-Only
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Patients who participated in Phase I clinical trials
Safety and Tolerability of Liraglutide in Healthy Volunteers and Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2; Healthy
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to assess the safety and
      tolerability (maximum tolerated dose) after single and multiple doses of NNC 90-1170
      (liraglutide) in healthy volunteers and in subjects with type 2 diabetes.
    


Intervention name(s): liraglutide; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Initial single dose followed by subsequent multiple s.c. (under the skin) doses on several dose levels (1.25, 5, 7.5, 10 and 12.5 mcg/kg). Each subject will be allocated to one dose level only; Initial single dose followed by subsequent multiple s.c. (under the skin) doses
Other intervention name(s): NNC 90-1170
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pilot Trial of Single Dose Ilofotase Alfa in Hypophosphatasia
Condition: Hypophosphatasia
MeSH terms: Hypophosphatasia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The goal of this clinical trial is to compare the effectiveness of two doses of ilofotase
      alfa, an enzyme replacement treatment, in patients with hypophosphatasia (HPP). The main
      question it aims to answer is if the harmful accumulating levels of extracellular inorganic
      pyrophosphate (PPi) and pyridoxal 5'-phosphate (PLP) can be reduced with ilofotase alfa.

      Researchers will compare the two doses of ilofotase alfa to see if treatment effects differ
      between the doses.
    

Detailed description: 
      Recombinant human alkaline phosphatase (ilofotase alfa) is a full-length human chimeric
      alkaline phosphatase (ALP) that could benefit patients with hypophosphatasia (HPP), which is
      characterized by low activity of tissue-nonspecific isoenzyme of alkaline phosphatase
      (TNSALP).

      This is a pilot trial for a potential future trial aimed at identifying whether treatment
      with ilofotase alfa can normalize circulating levels of PPi, PLP and other biochemical
      markers of TNSALP deficiency along with the safety/tolerability of different doses of
      ilofotase alfa. The trial is designed as a single-center, open-label, randomized, parallel
      group clinical trial in adult patients with HPP. Two different dose levels (0.8 mg/kg and 3.2
      mg/kg) of ilofotase alfa will be assessed.

      Participants will receive a single dose of ilofotase alfa, administered as a 1-hour
      intravenous infusion on Study Day 1. Participants will stay at the research center for a
      total of 12 days; from 2 days before study drug administration (run-in) to 10 days after
      treatment. An additional follow-up assessment is scheduled 14 days after administration of
      ilofotase alfa.

      Blood and urine samples will be taken daily for drug concentration and laboratory
      measurements assessing safety and effectiveness of treatment. In addition physical
      examinations will be performed on Day 1 and as needed afterwards.
    

Intervention name(s): Ilofotase Alfa, 0.8 mg/kg; Ilofotase Alfa, 3.2 mg/kg
Intervention type(s): Biological; Biological
Intervention description(s): Biological: single 1-hour intravenous infusion of 0.8 mg/kg ilofotase alfa; Biological: single 1-hour intravenous infusion of 3.2 mg/kg ilofotase alfa
Other intervention name(s): recAP; recAP
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 doses will be compared
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Enzyme replacement therapy
The Effect of Trendelenburg Lithotomy Position on Pain and Procedural Time During Vaginoscopic Office Hysteroscopy
Condition: Uterine Diseases
MeSH terms: Uterine Diseases
Study type: Interventional

Summary: 
      The present study revealed that the TL position is supposed to be more efficient not only for
      lowering pain score but also reducing the procedural time. Also, performing hysteroscopy in
      this position may be easier for doctors than in the lithotomy position.
    

Detailed description: 
      VOH is a widely used diagnostic method and seems to be getting more into outpatient clinics.
      Despite its huge contribution to clinical practice, pain during the procedure is an important
      limiting factor. We aimed to investigate the effect of the trendelenburg lithotomy position
      to the pain and procedural time.However, there is a scarcity of research on this subject.
      Therefore, the rationale of the study was to enlighten the gap in the literature regarding
      the pain score and procedural time during VOH for diagnostic purposes in TL position. In
      order to gain scientific evidence, a randomized controlled trial was conducted to compare
      pain score and duration of procedure between the standard lithotomy position and TL position.
      Also, the convenience for the physician performing the procedure was assessed. To the best of
      our knowledge, this is the first study in the literature investigating the effect of the
      position of the patient during the procedure on both time, pain, and the convenience for the
      physician simultaneously.
    

Intervention name(s): vaginoscopic office hysteroscopy
Intervention type(s): Procedure
Intervention description(s): comparison of procedural time and pain scores of patients in different gynecologycal positions
Other intervention name(s): positions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: vaginoscopic office hysteroscopy; lithotomy position; trendelenburg lithotomy position; visual pain score; procedural time; Likert scale
Effects of Ischemic Preconditioning on Muscle Damage Induced by Excentric Exercise
Condition: Healthy
MeSH terms: Ischemia
Study type: Interventional

Summary: 
      Introduction: eccentric exercise (EE) has been widely used in rehabilitation and in improving
      physical fitness due to its mechanical advantage and less metabolic demand, however, EE can
      induce muscle damage providing structural changes and reduced muscle function, therefore, it
      is necessary to look for alternatives to reduce this damage caused by stress. Thus, ischemic
      preconditioning (PCI) can be seen as an aid in reducing the damage caused by EE, as it can
      attenuate the ischemia-reperfusion injury, and can be used to accelerate the post-exercise
      recovery process. Objectives: to compare the effects of PCI, using different occlusion
      pressures, on acute and late responses to perceptual outcomes and muscle injury markers, in
      addition to checking whether the technique causes deleterious effects on performance in
      post-exercise recovery. Methods: a randomized placebo controlled clinical trial will be
      conducted with 80 healthy men aged 18 to 35 years who will be randomly divided into four
      groups: PCI using total occlusion pressure (POT), PCI with 40% more than POT, placebo (10
      mmHg) and control. The PCI protocol will consist of four cycles of ischemia and reperfusion
      of five minutes each. All groups will perform an EE protocol, initial assessments,
      immediately after the end of the EE, 24, 48, 72 and 96 hours after exercise, with the maximum
      isometric voluntary contraction (CVIM) assessed by the isokinetic dynamometer, vectors of
      cell integrity by by means of electrical bioimpedance (BIA), creatine kinase (CK), blood
      lactate, pain on the visual analog scale (VAS), pain threshold by the pressure algometer, and
      tone, muscle rigidity and elasticity by myotonometry. The descriptive statistical method and
      analysis of variance will be used for the repeated measures model. The level of significance
      will be p <0.05.
    


Intervention name(s): Ischemic Preconditioning
Intervention type(s): Device
Intervention description(s): The IPC is characterized by the application of brief periods of circulatory occlusion (ischemia) and reperfusion of a limb in the minutes to hours that precede the exercise through the insufflations and deflations of a pressure cuff
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Ischemic Preconditioning; Exercise; Musculoskeletal Pain; Creatine Kinase; Muscle Fatigue; Stress, Physiological
A Study to Evaluate the Pharmacokinetics of Avacopan (CCX168) in Participants With Mild or Moderate Hepatic Impairment
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study will be to evaluate the pharmacokinetic properties of
      avacopan and its metabolite CCX168-M1 after a single oral dose of 30 mg avacopan in
      participants with mild or moderate hepatic impairment compared to matched healthy controls.
    


Intervention name(s): Avacopan
Intervention type(s): Drug
Intervention description(s): Administered orally.
Other intervention name(s): CCX168
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Liver disease; Anti-neutrophil cytoplasmic antibody-associated vasculitis; Complement C5a receptor (C5aR)
A Study Comparing Two Treatments for Infants With Hydrocephalus
Condition: Hydrocephalus
MeSH terms: Hydrocephalus
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to study whether infants with triventricular hydrocephalus (TVH)
      have a better long-term outcome at 5 years when they are treated with a new procedure,
      endoscopic third ventriculostomy (ETV), than infants treated with the more traditional
      treatment, insertion of a cerebrospinal fluid (CSF) shunt.
    

Detailed description: 
      TVH is a relatively uncommon condition in infants, in which CSF accumulates in the brain's
      ventricles due to a blockage in outflow at the level of cerebral aqueduct. This can cause
      increased intracranial pressure, with adverse effect on brain development. The causes of this
      include congenital aqueductal stensois or acquired aqueductal stenosis from previous brain
      hemorrhage or infection.

      TVH is currently treated through one of the following two approaches:

        -  Extra-cranial CSF diversion through ventricular shunts. Extra-cranial shunting has been
           the standard approach over the past few decades, since functional shunts were first
           developed and inserted successfully.

        -  Intra-cranial internal CSF diversion using endoscopic techniques. The principles of
           internal diversion were clear from the time neurosurgeons first understood the nature of
           hydrocephalus. However, internal diversion was never really practical or successful on a
           large scale until the more recent development of neuroendoscopy. There is currently a
           revived interest in diversionary hydrocephalus treatment through neuroendoscopic
           surgical techniques, with the primary focus on endoscopic third ventriculostomy (ETV).
    

Intervention name(s): Endoscopic Third Ventriculostomy; CSF Shunt Insertion
Intervention type(s): Procedure; Procedure
Intervention description(s): A standard frontal burr hole will be made and an endoscopic camera used to visualize the floor of the third ventricle. A ventriculostomy will be created in the floor of the third using the surgeon's own preferred method of perforation.; The procedure involves creating a burr hole in the frontal or occipital regions and cannulating the ventricle with a silastic catheter. This is then attached to a valve mechanism and distal silastic tubing which runs subcutaneously in the peritoneal cavity.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: infants; Hydrocephalus; Cerebrospinal Fluid Shunt; Ventriculostomy; neurosurgery
Statin Effects on Beta-Amyloid and Cerebral Perfusion in Adults at Risk for Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the research is to see how simvastatin affects a substance in the body called
      beta-amyloid. Beta-amyloid is found in the brain and in the liquid around the brain and
      spinal cord. High amounts of beta-amyloid may be associated with a greater risk of getting
      Alzheimer's disease. This study will see if simvastatin can lower the amount of beta-amyloid
      in the spinal fluid. This study will also see if simvastatin affects memory and thinking,
      blood flow in the brain, and blood vessel function. The investigators hope that future
      studies show whether simvastatin might prevent memory loss and decrease the chance of
      developing Alzheimer's disease.
    

Detailed description: 
      Studies show that some medicines that lower cholesterol may reduce the risk of developing
      Alzheimer's disease, but this has not yet been proven in humans. We are looking for
      individuals to participate in this study to see if a cholesterol-lowering medication, called
      simvastatin affects blood flow to the brain, blood vessel function and a substance in the
      spinal fluid related to the changes in Alzheimer's disease.

      The SHARP study included 88 adults ages 40-72 with parental history of documented Alzheimer's
      disease. The study had 9 visits over the course of 18 months. Participants had fasting blood
      tests collected, completed a medical history questionnaire and medication side effect review,
      underwent lumbar puncture procedure, completed memory testing, and had ultrasound and MRI
      procedures. Participants were randomly assigned to receive either simvastatin or a placebo
      each night for 18 months.
    

Intervention name(s): Simvastatin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 40 mg Simvastatin/day; Matching Placebo
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Study to Assess BHQ880 in Combination With Zoledronic Acid in Relapsed or Refractory Myeloma Patients
Condition: Multiple Myeloma Bone Disease
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Bone Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study has two portions, a phase I portion and a phase II portion. The purpose of the
      phase I portion is to assess the maximum-tolerated dose (MTD) and to characterize dose
      limiting toxicity (DLT) of escalating doses of BHQ880 (up to a maximum dose of 20 mg/kg) in
      combination with standard chemotherapy and zoledronic acid in relapsed or refractory multiple
      myeloma patients.

      The phase II portion of the study will also be conducted in relapsed or refractory multiple
      myeloma patients. Patients will be treated with various doses of BHQ880 or placebo in
      combination standard chemotherapy. In the phase II portion of the study zoledronic acid will
      be added after the first 28 days of therapy with BHQ880 or placebo and standard chemotherapy.
      This will allow any BHQ880-related changes in bone biomarkers to be detected in a zoledronic
      acid-free environment. The purpose of the phase II portion of the study, is to determine one
      or more doses of BHQ880 for further development based on dose-efficacy modeling. Efficacy is
      defined as time to first skeletal-related event and change in bone markers for bone
      resorption and formation relative to placebo. A skeletal-related event is defined as:

        -  Pathologic fracture

        -  Spinal cord compression

        -  Requirement for either radiation or surgery to bone due to:

             -  Pain

             -  Prevention of imminent fracture

             -  Stabilization of a fracture Biomarker and imaging endpoints will be assessed in
                both phases of the study. The pharmacodynamic effects of BHQ880 will be assessed by
                measuring biochemical markers of bone formation, resorption, and metabolism in
                serum and urine. Charges in serum DKK1 levels will be characterized. The size and
                number of lytic bone lesions as measured by bone survey (X-ray) or MRI will be
                assessed. In addition, bone mineral density (BMD) will be measured by DEXA scan and
                at selected sites with QCT scans.
    

Detailed description: 
      The study was originally planned to have two phases. Phase II, the dose expansion phase, was
      not conducted.
    

Intervention name(s): BHQ880; Zoledronic acid
Intervention type(s): Drug; Drug
Other intervention name(s): ZOL446
Intervention MeSH terms: Zoledronic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple myeloma; bone disease; antibody
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Single and Repeated Doses of Topical GSK1278863
Condition: Wound Healing
MeSH terms: Diabetic Foot; Foot Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, placebo-controlled, single-blind (subjects and investigators will be
      blinded, GSK internal personnel will not be blinded), parallel-group, two part (Part A, Part
      B) trial in healthy volunteers and subjects with diabetic foot ulcers. Part A is designed to
      evaluate single applications of GSK1278863 in one cohort of healthy volunteers (intact skin)
      and approximately 3 cohorts of diabetic subjects. Part B is designed to evaluate first
      single, and then repeat applications of GSK1278863 in diabetics, both in the clinic and by
      subjects at home. Part B will include approximately 3 cohorts in which the concentration of
      drug applied will be determined by pharmacokinetic data from Part A and earlier cohorts in
      Part B.
    


Intervention name(s): GSK1278863; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): White to off-white smooth ointment with unit dose strength of 0.05%w/w, 0.1%w/w, 0.5%w/w, 1.0%w/w for topical application as single or repeat doses.; White to off-white smooth ointment for topical application as single or repeat doses.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: diabetic foot ulcer; pharmacodynamics; pharmacokinetics; ischemic
Effect of Modified Dental Visual Aids on Behavior Management During Dental Treatment in Children With Autism Spectrum Disorder
Condition: Child Autism
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      There is a need to find an approach that is appropriate for managing children with Autism
      Spectrum Disorder in the dental clinic, to manage their behaviour and decrease their anxiety
      in this research we will apply our modified dental visual aids and test its effectiveness in
      managing the behavior of such children during the dental appointment.
    


Intervention name(s): Modified dental visual aids; Regular dental visual aids
Intervention type(s): Other; Other
Intervention description(s): Modified Dental visual aids in the form of pictures created by the main investigator; Regular dental visual aids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other