bioihbjkbjnl/mcl2 huggingface dataset:
An Inpatient Study of ALLN-346 (Engineered Urate Oxidase) in Hyperuricemic Subjects (Study 201)
Condition: Hyperuricemia; Gout; Chronic Kidney Diseases
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hyperuricemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this Phase IIa study is to evaluate the safety and tolerability of ALLN-346 in
      subjects with hyperuricemia in an inpatient, controlled setting.
    

Detailed description: 
      This is a Phase II, 7-day, randomized, double-blind, placebo-controlled study of orally
      administered ALLN-346 in subjects with hyperuricemia, with subpopulations to include
      generally healthy hyperuricemic subjects with normal kidney function and those with mild to
      moderate chronic kidney disease (CKD). Study will take place at a clinical pharmacology unit
      (CPU). The study will have two Parts. Part 1 will include subjects with serum urate ≥ 6.8
      mg/dL and eGFR ≥ 60 mL/minute/1.73 m2 (subjects with eGFR of stage 2 CKD and with normal
      kidney function). Part 2 will include subjects with serum urate ≥ 6.8 mg/dL and eGFR 45-100
      mL/minute/1.73 m2 (eGFR of CKD Stages 2- 3a).

      The study will evaluate safety, tolerability, pharmacokinetics (lack of absorption) and
      pharmacodynamics of ALLN-346.
    

Intervention name(s): ALLN-346; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ALLN-346 (Engineered Urate Oxidase) is an orally administered, novel urate oxidase; provided as capsules for oral administration; Matched placebo capsules are similar in weight and appearance to the ALLN-346 capsules
Other intervention name(s): Engineered urate oxidase; Matching placebo capsule
Intervention MeSH terms: Rasburicase
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Study population includes generally healthy subjects with hyperuricemia without CKD, and those with eGFR of mild-moderate CKD. The maximal tolerated dose from the MAD study in normal healthy volunteers (Study 102) will be administered. The study is comprised of two Parts. Under optional Part 2, only subjects with eGFR of CKD Stages 2- 3a.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Bowman-Birk Inhibitor Concentrate in Healthy Men
Condition: Healthy, no Evidence of Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized phase I trial is studying the side effects and best dose of Bowman-Birk
      inhibitor concentrate in healthy men. Chemoprevention is the use of certain drugs to keep
      cancer from forming. The use of Bowman-Birk inhibitor concentrate may prevent cancer.
    

Detailed description: 
      OBJECTIVES:

      I. Assess the toxicity of single-dose Bowman-Birk Inhibitor Concentrate (BBIC) when
      administered as a suspension in orange juice in healthy male participants.

      II. Determine the appropriate dose range and doses to be used in a subsequent phase I
      multiple-dose BBIC study that will be based upon the data gathered from this phase I
      single-dose study.

      III. Characterize the pharmacokinetics of single-dose BBIC.

      OUTLINE: This is a dose-escalation study of Bowman-Birk Inhibitor Concentrate (BBIC).
      Participants are sequentially assigned to 1 of 4 dose level cohorts. One participant in each
      dose level cohort is randomized to receive placebo or BBIC.

      Participants receive a single dose of oral BBIC or placebo, as an orange juice suspension,
      immediately followed by consumption of a defined low-fat breakfast. Participants continue to
      consume a low-fat diet for the next 48 hours and then resume their normal diet.

      Participants undergo blood and urine sample collection periodically for pharmacokinetic
      studies. Samples are analyzed by a sandwich enzyme-linked immunosorbent assay to measure
      concentrations of BBIC and its metabolites in serum and urine.

      After completion of study treatment, participants are followed once weekly for 4 weeks.
    

Intervention name(s): Bowman-Birk inhibitor concentrate; placebo; pharmacological study; laboratory biomarker analysis
Intervention type(s): Drug; Other; Other; Other
Intervention description(s): Given orally; Given orally; Correlative studies; Correlative studies
Other intervention name(s): BBIC; PLCB; pharmacological studies
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Testing the Effectiveness and Safety of a Passive Industrial Exoskeleton for Back Support
Condition: Prevention of Diseases of the Musculoskeletal System
Study type: Interventional

Summary: 
      This research will provide data on evaluation of the effectiveness and safety of using a
      passive exoskeleton designed to reduce the negative impact of static and dynamic loads
      associated with body tilts, lifting and holding weights on the musculoskeletal system of
      workers. To evaluate a passive industrial exoskeleton for back support, a protocol was
      developed in which individual production operations will be modeled.
    

Detailed description: 
      This research will recruit 12 volunteers. During a 4-hour laboratory visit, each subject will
      perform two identical experimental tests: one test without an exoskeleton and another one
      using the exoskeleton. To avoid sequence bias, the test order will be randomized (balanced).
      The labor operation will be simulated. This operation will consist of lifting the load, which
      is 20 kg off the floor, walking 1.5m to a surface with a height of 70 cm to put it on, the
      frequency of lifting is 1 time in 30 seconds. The work will be performed for 105 minutes,
      then a break of 15 minutes, then 105 minutes of work. Heart rate (Polar) will be monitored.
      An ergospirometric device (Metamax) will be used to collect muscle activity data (Trust-M,
      Myoton), inertial sensors (Trust-M) will be used to evaluate the biomechanics of movements.
      In addition, questionnaires will be filled out for a subjective assessment of the use of
      exoskeleton prototypes (local discomfort scale, exoskeleton properties assessment
      questionnaire).
    

Intervention name(s): Passive industrial exoskeleton for back support; The protocol will be performed without exoskeleton
Intervention type(s): Device; Other
Intervention description(s): The goal is to compare the human response to the simulated industrial tasks; The protocol will be performed without exoskeleton
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized counterbalanced cross-over design
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: industrial exoskeleton; exoskeleton; passive industrial exoskeleton
Participatory Evaluation (of) Aging (With) Rapamycin (for) Longevity Study
Condition: Aging
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, placebo-controlled trial into the safety and efficacy in reducing
      clinical measures of aging in an older adult population.
    

Detailed description: 
      A randomized, double-blind, placebo-controlled trial assessing the effects of low and high
      doses of intermittent Rapamycin on a weekly schedule. The researchers aim to establish a
      long-term safety profile, determine the long-term efficacy of Rapamycin in reducing clinical
      aging measures, and biochemical and physiological endpoints associated with declining health
      and aging in healthy older adults.
    

Intervention name(s): Rapamycin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Rapamycin in 2 different dosage forms.; Placebo capsules
Other intervention name(s): Sirolimus; Rapamune; Rapacan; Siromus; Raparen; Rapasim; Sirova
Intervention MeSH terms: Sirolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, Double-Blind, Placebo-Controlled Trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: rapamycin; aging; longevity; sirolimus; healthy aging; age-related conditions
Efficacy of Fish Oil in Multiple Sclerosis
Condition: Relapsing- Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the present work was to evaluate the efficacy of fish oil supplementation on serum
      proinflammatory cytokines levels, oxidative stress markers and disease progression in MS.
    

Detailed description: 
      Current research findings suggest that Omega-3 polyunsaturated fatty acids (PUFA) such as
      eicosahexanoic acid (EPA) and docosahexaenoic acid (DHA) contained in fish oil may have
      anti-inflammatory, antioxidant and neuroprotective effects. The aim of the present work was
      to evaluate the efficacy of fish oil supplementation on serum proinflammatory cytokines
      levels, oxidative stress markers and disease progression in MS. 50 patients with
      relapsing-remitting MS were enrolled. The experimental group received orally 4 g/day of fish
      oil for 12 months. The primary outcome was serum TNFα levels; Secondary outcomes were IL-1β,
      IL-6, nitric oxide catabolites, lipoperoxides, progression on the expanded disability status
      scale (EDSS) and annualized relapses rate (ARR).
    

Intervention name(s): Fish Oil; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Patients received 4g/day Omega Rx capsules (Dr. Sears zone diet) containing 0.8 g EPA and 1.6 g DHA and excipient (glycerin, water purified, tocopherol, sunflower oil and titanium dioxide), during 12 months.; Orally, 4 Capsules per day, (glycerin, water purified, tocopherol, sunflower oil and titanium dioxide), during 12 months.
Other intervention name(s): PUFAS; Omega 3; Control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: R-R MS
Study to Evaluate TRV120027 on Renal Pharmacodynamics in Patients With Heart Failure and Renal Dysfunction
Condition: Heart Failure; Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency; Heart Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and
      pharmacodynamics of TRV120027 in subjects with heart failure and mild to moderate renal
      dysfunction.
    


Intervention name(s): TRV120027; Normal Saline
Intervention type(s): Drug; Drug
Intervention description(s): IV infusion; IV infusion
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Reliability of an Objective Measurement to Assess Lumbar Spine Motion in Healthy Controls and in Low Back Pain Patients
Condition: Reliability, Validity of Measurement to Assess Lumbar Spine Motion; Comparison of Healthy Subjects and Low Back Pain Patients
MeSH terms: Back Pain; Low Back Pain
Study type: Observational

Summary: 
      Main of the study is to assess the reliability of a new objective tool to measure lumbar
      spine motion. The data will be collected from healthy subjects and subjects with frequent or
      daily low back pain in the last three months. In addition we compare the results of the
      motion measurements with disability and pain questionnaires such as the Roland Morris,
      Oswestry Disability Index and the Brief Pain Inventory.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Low back pain patients were recruited among in-and outpatients of the Department of Pain
        Medicine at the Bergmannsheil, Bochum. The subjects of the control groups were recruited by
        distributing flyers in sport groups and among hospital staff and friends.
Neuroprotective Effects of Remote Ischemic Preconditioning (RIPC) During Infant Cardiac Surgery
Condition: Heart Defects, Congenital
MeSH terms: Heart Defects, Congenital; Congenital Abnormalities
Study type: Interventional

Summary: 
      The purpose of this study is to look at whether the use of a simple technique before surgery,
      which involves inflating a blood pressure cuff on the infant's leg, can improve development
      of language, motor and thinking skills at 12 months of age. Some research has found that a
      brief shortage of blood supply to an organ (such as a leg) at level that does not cause harm
      may help the body to tolerate a longer and more severe shortage of blood (for example, during
      surgery).
    

Detailed description: 
      The purpose of this study is to look at whether the use of a simple technique before surgery,
      which involves inflating a blood pressure cuff on the infant's leg, can improve development
      of language, motor and thinking skills at 12 months of age. Some research has found that a
      brief shortage of blood supply to an organ (such as a leg) at level that does not cause harm
      may help the body to tolerate a longer and more severe shortage of blood (for example, during
      surgery).

      Neurodevelopmental Assessment:

      The Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III)9 assesses the
      developmental functioning of infants and young children between the ages of 1 month and 42
      months. Cognitive, language, and motor development are assessed through structured play
      activities. Social-emotional and adaptive functioning are assessed through parent
      questionnaires. Administration time is 45 - 60 minutes, depending on the child's performance
      and behavior. Psychometric properties are well defined and acceptable. Composite scores for
      cognitive, language, motor, social-emotional, and adaptive behavior are standardized with a
      mean of 100 and a standard deviation of 15.

      The Infant Development Inventory (IDI)10 will also be used to assess neurodevelopmental
      functioning, based on parent report. Parents are asked to rate their child's developmental
      skills in five domains: social, self help, gross motor, fine motor and language.
      Administration time is approximately 10 minutes. Infants are categorized as delayed or not
      delayed for each of the five domains.
    

Intervention name(s): Remote Ischemic Preconditioning; Control
Intervention type(s): Procedure; Other
Intervention description(s): Lower limb ischemia/reperfusion cycles; Sham placement of blood pressure cuff without inflation
Other intervention name(s): RIPC; Remote Ischemic Conditioning; Sham
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Remote ischemic preconditioning; Heart defects, congenital; cardiac surgery; Neurodevelopmental outcomes
GEM 1.5 mg b.i.d. to 4.5 mg b.i.d. Versus Lorazepam in GAD (0777-026)
Condition: Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will determine the effectiveness of MK0777 GEM versus Lorazepam in the treatment
      of patients with generalized anxiety disorder.

      This is an early phase trial and some specific protocol information is in progress and not
      publicly available at this time. (Full information is available to trial participants).
    


Intervention name(s): MK0777
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Study of A4368 in Healthy Subjects
Condition: Health Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      A4368 is the autophagy activator that is being developed for the treatment of nonalcoholic
      steatohepatitis.

      The goal of the study is to assess the safety, tolerability, and pharmacokinetics in healthy
      subjects.
    


Intervention name(s): A4368 or placebo tablet
Intervention type(s): Drug
Intervention description(s): orally administered
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate P-Glucose, Safety and Tolerability After Oral Single Dosing of AZD6370 in Type 2 Diabetic Patients
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of AZD6370 on blood sugar and to study
      safety and tolerability in patients with type 2 diabetes.
    


Intervention name(s): AZD6370; AZD6370; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral single doses a+b+c, o.d., suspension; Oral single dose, o.d., b.i.d. and q.i.d., suspension; Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Type 2 diabetes
Evaluation of the Prophylactic Efficacy of tDCS in Chronic Migraine
Condition: Chronic Migraine as Defined by Criteria of International Headache Society (IHS)
MeSH terms: Migraine Disorders; Headache
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether TDCS is an effective prophylactic therapy
      of chronic migraine.
    

Detailed description: 
      Consenting patients will report on a book, all of their migraine attack for 1 month. Then
      they will be randomized to the active tDCS group or sham tDCS group. Patients will have one
      session of tDCS per day during the first week, then one session per week for a month and
      finally a session every 15 days for 1 month. After tDCS sessions, patients will be followed
      for 3 months. Throughout their participation in the study, patients will complete their
      migraine record (1month of base line before tDCS, 2 months during tDCS, 3 months after tDCS).

      Patients will have 5 evaluation examinations:

        -  The first, one before tDCS,

        -  The second, 1 month after the beginning of tDCS

        -  The third, immediately after the end of tDCS

        -  The fourth, 1 month after the end of tDCS

        -  And the last one, 3 months after the end of tDCS.

      The physician responsible for conducting tDCS sessions will make the randomization via a
      website.

      The physician in charge of the evaluation examinations will don't know the allocated
      treatment.
    

Intervention name(s): Transcranial direct current stimulation of the motor cortex; simulation of Transcranial direct current stimulation of the motor cortex
Intervention type(s): Device; Device
Intervention description(s): The area of stimulation is determined by by EEG system 10/20. The two electrodes are soaked in saline and then placed on the scalp.
Stimulation parameters:
2 mA intensity
Continuous stimulation for 20 min with rise times and fall times of 10 seconds each; The area of stimulation is determined by by EEG system 10/20. The two electrodes are soaked in saline and then placed on the scalp.
Stimulation parameters:
The intensity of the stimulation current is 2 mA
The current is applied during the first 30 seconds with rise times and fall times of 10 seconds each. Then the session will be continued without actual stimulation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic migraine, tDCS, Transcranial direct current stimulation
PEAK PlasmaBlade™ vs. Traditional Electrosurgery in Abdominoplasty
Condition: Elastosis
Study type: Interventional

Summary: 
      The objective of this clinical study is to evaluate healing of incisions made with the PEAK
      PlasmaBlade 4.0 compared to scalpel and traditional electrosurgery (Bovie); to monitor and
      record key post-operative metrics following abdominoplasty with the PEAK PlasmaBlade 4.0
      versus current standard of care (SOC); and to evaluate performance metrics of the PEAK
      PlasmaBlade 4.0 during abdominoplasty.
    

Detailed description: 
      Abdominoplasty is a cosmetic surgical procedure performed to correct abdominal elastosis with
      skin and fat redundancy. During the procedure, a scalpel and traditional electrosurgical
      device are used to cut away this excess skin and fat from the abdomen and the underlying
      muscles are tightened together with sutures.

      The PEAK PlasmaBlade™ uses pulsed radiofrequency (RF) energy to enable precision cutting and
      coagulating at the point of application, without the thermal damage to surrounding tissues
      that is normally seen with traditional electrosurgery. The PlasmaBlade has received FDA
      clearance for use in plastic, general, and ear, nose, and throat (ENT) surgery, and has
      demonstrated significantly reduced serous drainage in tissue reduction surgeries, like
      abdominoplasty.

      A total of twenty (20) human subjects were recruited from the local community against
      standardized inclusion/exclusion criteria. Once enrolled, each patient underwent placement of
      three sets of full-thickness comparison incisions in their abdominal skin with a standard
      scalpel, PlasmaBlade, and traditional electrosurgery at six (6) and three (3) weeks prior to
      abdominoplasty, and on the day of surgery under general anesthesia. Subjects were then
      randomized to undergo abdominoplasty with the PlasmaBlade or the SOC (scalpel and traditional
      electrosurgery). Following abdominoplasty, harvested healed incisions were submitted for
      histological analysis and burst strength testing and additional data were recorded in the 10
      day post-operative period.
    

Intervention name(s): PEAK PlasmaBlade; Standard of Care (SOC)
Intervention type(s): Device; Procedure
Intervention description(s): The PEAK PlasmaBlade will be used for the abdominoplasty procedure.; The scalpel and electrocautery will be used for the abdominoplasty procedure.
Other intervention name(s): PlasmaBlade; Bovie; electrocautery; electrosurgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Abdominoplasty; PlasmaBlade; Electrosurgery; PEAK Surgical; Medtronic Advanced Energy; Medtronic
Safety and Efficacy of KALOMIN™ Tab. in Patients With Acute Bronchitis
Condition: Acute Bronchitis
MeSH terms: Bronchitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multi-center, double-dummy, double-blind, randomized, active-controlled, parallel
      group phase 3 clinical trial to evaluate the efficacy and safety of KALOMIN™ Tab. in patients
      with acute bronchitis.

      The aim of this clinical trial is to demonstrate that KALOMIN™ Tab. is clinically
      non-inferior to Umckamin syrup, as assessed by BSS(Bronchitis Severity Score), in the
      treatment of acute bronchitis after 7 days.
    


Intervention name(s): KALOMIN™ Tab.; Umckamin syrup
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment