bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate the Safety and Pharmacodynamic/Pharmacokinetic Characteristics of HIP2101 in Healthy Volunteers
Condition: Healthy Adult Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1 Study to Evaluate the Safety and Pharmacodynamic/Pharmacokinetic Characteristics of
      HIP2101 in Healthy Volunteers
    

Detailed description: 
      A Randomized, Open-label, Multiple-dose, Crossover Phase 1 Clinical Trial to Evaluate the
      Safety and Pharmacodynamic/Pharmacokinetic Characteristics after Oral Administration of
      HIP2101 in Healthy Adult Volunteers
    

Intervention name(s): HIP2101; RLD2101
Intervention type(s): Drug; Drug
Intervention description(s): Test drug; Reference drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Tolperisone in Acute Muscle Spasm of the Back
Condition: Back Pain; Acute Pain; Back Spasm Upper Back; Back Strain; Muscle Cramp; Muscle Spasm; Low Back Pain
MeSH terms: Muscle Cramp; Spasm; Hyperkinesis; Back Pain; Low Back Pain; Acute Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a double-blind, randomized, placebo-controlled, parallel group study of the efficacy
      and safety of tolperisone (a non-opioid) or placebo administered as multiple doses three
      times a day (TID) in approximately 400 male and female subjects experiencing back pain due to
      or associated with muscle spasm.
    


Intervention name(s): Tolperisone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TID; Placebo
Intervention MeSH terms: Tolperisone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Speech Analysis as a Diagnostic Tool for Mild Traumatic Brain Injury
Condition: Concussion
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
Study type: Interventional

Summary: 
      The waveform assessment of an athlete's speech production has a high probability of showing
      abnormalities after brain injury (concussions) which could be used not only for diagnosis of
      the concussion, but for recovery of the brain. The aim of this study is to investigate this
      possibility using the Cobweb automated application system for acoustic processing.
    

Detailed description: 
      Concussions affect cognitive and fine muscle motor control, and these changes will be
      reflected in the acoustic characteristics of the vowels being produced. The methods to
      identify and analyze the acoustics of vowels will greatly extend the detailed understanding
      of vowels produced after a concussion. The identification of the changes in formant
      frequencies, pitch, and duration will provide the means to use these parameters as an
      automated diagnostic tool. The waveform assessment of the athlete's speech production has a
      high probability of showing brain abnormalities immediately after a suspected or diagnosed
      concussion at the venue of the athletic sport. The aim of this study assessment is to
      investigate this possibility using the Cobweb system and greatly enhance the ability to
      diagnose a concussion in a timely manner to remove the athlete from practice or play.
    

Intervention name(s): Voice recording
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: concussion, athlete, speech analysis
Regenexx™ SD Versus Exercise Therapy for Rotator Cuff Tears
Condition: Rotator Cuff Tear
MeSH terms: Rotator Cuff Injuries
Study type: Interventional

Summary: 
      The primary objective of this study is to compare the improvement in subject-reported
      clinical outcomes, for Regenexx SD treatment vs. Exercise Therapy of non-retracted
      supraspinatus tendon tears, from baseline to 3 months, with continued evaluation of efficacy
      and durability up to 24 months.

      Secondary objectives include evaluation of US evidence of tendon repair; incidence of
      post-operative complications, adverse events, re-injections, and surgical intervention;
      change in pain score and use of pain medications.
    

Detailed description: 
      Prospective, randomized, controlled to include 34 subjects treated with Regenexx SD and 17
      subjects treated with Exercise Therapy alone (2:1 randomization).

      Subjects will have a non-retracted supraspinatus tendon tear comprising at least one half the
      tendon thickness in the anterior-posterior and/or superior-inferior planes as evidenced with
      positive diagnostic imaging such as arthrogram, ultrasound and/or MR.

      Subjects will be enrolled within 60 days prior to Regenexx-SD injection or initiation of
      exercise therapy and take part in follow-up visits for two years following treatment. A
      preoperative visit will occur at the time of enrollment; follow-up visits will occur at the
      clinical site at 6 weeks, 3 months, 6 months, 12 months, and 24 months post injection.

      The primary endpoint analysis will be conducted once all subjects reach the 3 month endpoint.
      At that point, subjects enrolled in the Exercise Therapy group will be given the option of
      crossing over to the Regenexx SD treatment groups. Subjects will continue to be followed
      through the 2 year endpoint with data analysis performed at the 1 year and 2 year time
      points.

      Subjects will complete the study following the 2 year follow-up visit.
    

Intervention name(s): Regenexx SD; Exercise Therapy
Intervention type(s): Procedure; Other
Intervention description(s): stem cell treatment; exercise therapy control
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rotator Cuff; Rotator Cuff Tear; Supraspinatus Tear
Increased Physical Activity in African-American Women
Condition: Cardiovascular Diseases; Heart Diseases
MeSH terms: Cardiovascular Diseases; Heart Diseases
Study type: Observational

Summary: 
      To conduct a randomized demonstration and education trial of churches in East Baltimore
      testing a self-help, minimal intervention compared with an intensive physical activity
      intervention.
    

Detailed description: 
      BACKGROUND:

      The study filled an existing gap by examining how a culturally sensitive physical activity
      intervention conducted in a community setting was associated with increased daily energy
      expenditure in African American women -- a group of women who are sedentary and at risk for
      health problems for which regular physical activity can provide benefits.

      DESIGN NARRATIVE:

      An evaluation was conducted of the effectiveness of a six-month moderate-intensity physical
      activity intervention for increasing total daily energy expenditure of sedentary
      African-American women who were between the ages of 50 and 70 years. The goal of the
      intervention was to increase total daily energy expenditure by 150 kilocalories per day and
      time spent in moderate-intensity physical activity by 30 minutes per day. Effects of
      increased physical activity on selected cardiovascular risk factors (e.g., peak oxygen
      uptake, blood pressure, HDL cholesterol, serum insulin and plasma glucose) were also
      determined. Six churches were randomized into intensive or minimal intervention status, and
      33 women per church were recruited, for a total of 100 women in each condition. The physical
      activity intervention consisted of twice-weekly aerobics classes conducted at the churches
      and additional group-and home-based programming. Volunteer lay leaders were trained as
      neighborhood exercise specialists to supplement certified aerobics instructors in conducting
      the intervention.

      The study completion date listed in this record was obtained from the "End Date" entered in
      the Protocol Registration and Results System (PRS) record.
Protective Mechanisms Against a Pandemic Respiratory Virus (SLVP024)
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to investigate and compare the human immune response in
      epithelial cells of the nasopharyngeal mucosa and in blood to live, attenuated influenza
      vaccine (LAIV) in adults and in children.
    

Detailed description: 
      The objective of the protocol is to investigate the human innate and adaptive immune
      responses in blood (only for adults) and nasopharyngeal mucosa resident cells to the live,
      attenuated influenza vaccine (LAIV) in both adults and children. The investigators hope to
      learn how the upper respiratory tract (URT) epithelial cells, the primary target of
      respiratory viruses, and the B cells and T cells, two major components of the immune system,
      respond to the influenza vaccine.

      The volunteers will be enrolled in two age groups:

      Group A: Up to 12 healthy non-twin volunteers, 2-8 years old, will be given seasonal LAIV.
      Each volunteer will complete a total of 3 visits. Volunteers will be divided in 2 sub-groups
      A-1 (n=6) and A-2 (n= 6) in order to collect nasopharyngeal swabs on different schedules (Day
      1 or Day 2). Volunteers will be assigned to these sub-groups based on convenience sampling.
      Both sub-groups will complete the Day 0 and Day 28 visits and one visit at either Day 1 or
      Day 2 post-immunization. Specimens will include nasopharyngeal swabs collected at Day 1 for
      Sub-group A1 and Day 2 for Sub-group A-2, and Day 28 for both sub-groups. No blood samples
      will be collected in this age group.

      Children with no prior influenza vaccine history will receive a second dose of vaccine (LAIV)
      at least 28 days after the first study dose, according to the ACIP guidelines.

      Group B: Up to 18 healthy non-twin volunteers, 18-49 yrs old, will be given seasonal LAIV
      vaccine. Each volunteer will complete a total of 5 visits. Volunteers will be divided into 3
      sub-groups B-1, B-2 and B-3 in order to collect nasopharyngeal swabs and blood specimens on
      different schedules (Day 0-6 hrs, Day 1 or Day 2). Volunteers will be assigned to these
      sub-groups based on convenience sampling. All sub-groups will complete visits at Day -7, Day
      0 pre-immunization, Day 7 and Day 28 and 1 additional time point: Sub-group B-1 at Day 0, 6
      hours post-immunization, Sub-group B-2 at Day 1 and Sub-group B-3 at Day 2. A nasopharyngeal
      swab will be collected at each visit except for Day 0 (baseline) and Day 7. A blood sample
      will be collected at each visit except Day -7
    

Intervention name(s): FluMist®
Intervention type(s): Biological
Intervention description(s): Influenza Virus Vaccine Live, Intranasal Spray
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Live, attenuated influenza vaccine; Children and young adults
Hydrolyzed Egg and Tolerance Induction
Condition: Allergy
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      The aim of this trial is to assess the effect of hydrolyzed egg orally administered on oral
      tolerance induction to egg in children allergic to egg as compared to a placebo.
    


Intervention name(s): HA egg
Intervention type(s): Dietary Supplement
Intervention description(s): Daily dose of HA egg or placebo for 6 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Allergy; Egg
A Phase 2 Extension Study of Study GCS-100-CS-4002
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to determine the safety and tolerability of extended
      dosing of GCS-100 in patients with CKD.
    

Detailed description: 
      Galectin-3 contributes to fibrosis, is elevated in patients with ESRD, and correlates with
      adverse outcomes. Animal models with genetic knockout of galectin-3 demonstrate a reduction
      in structural and functional deficits in the kidney. GCS-100 is a galectin-3 antagonist that
      has been shown to reduce fibrosis pre-clinically. Based on the role of galectin-3 and
      fibrosis in kidney disease, the Sponsor believes GCS-100 may be effective at treating
      patients with CKD.

      Study GCS-100-CS-4002 is an ongoing randomized, placebo controlled study of GCS-100 in Stage
      3b and 4 CKD. The objective of the study is to determine the safety and efficacy of 8 weekly
      injections of GCS-100 on eGFR. Patients who have completed that study without adverse safety
      events, may be asked to participate in this study to test the safety of prolonged
      administration of study drug.
    

Intervention name(s): GCS-100
Intervention type(s): Drug
Intervention description(s): 1.5 mg/m2 or 30 mg/m2 GCS-100. GCS-100 will be administered as IV infusions once weekly for 8 weeks with a 1 week and 4 week follow-up period and then at least every 30 days for up to a total of 1 year.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Phase 1 Study of FG-3019 in Subjects With Type 1 or Type 2 Diabetes Mellitus and Diabetic Nephropathy
Condition: Diabetes Mellitus; Diabetic Nephropathy
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of two dosing regimens
      of FG-3019 administered over 12 weeks in patients with diabetic nephropathy and proteinuria
      on background angiotensin converting enzyme inhibitor (ACEi) and/or angiotensin II receptor
      antagonist (ARB) therapy.
    


Intervention name(s): FG-3019; FG-3019; FG-3019
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo every 2 weeks IV for all infusions; FG-3019 5 mg/kg every 2 weeks IV for all infusions; FG-3019 10 mg/kg IV for infusions on Days 1, 15, 29 and 57 and Placebo IV on Days 43 and 71
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Type 1 or Type 2 diabetes; proteinuria
Translating Habituation Research to Interventions for Pediatric Obesity
Condition: Pediatric Obesity; Habituation
MeSH terms: Obesity; Pediatric Obesity; Substance-Related Disorders
Study type: Interventional

Summary: 
      The purpose of this center grant is to translate basic behavioral science on habituation
      theory into clinical intervention using a vertical hierarchical approach from laboratory
      studies to field studies to the clinical intervention to improve weight loss outcomes in
      pediatric obesity treatment.
    

Detailed description: 
      Habituation is one factor that may be related to excess energy intake. Research has shown
      that the rate of habituation is inversely related to the amount of food consumed and slower
      habituation may be a factor that is relevant to obesity, as overweight youth and adults
      habituate slower and consume more energy than their peers. Habituation is a basic form of
      learning that is observed in many response systems. We believe that habituation is an
      important process that mediates food regulation during a meal and across meals. However,
      there has been no research in children that translates basic research on habituation to food
      into clinical interventions for pediatric obesity. In the first phase, we will implement a
      series of laboratory studies to assess the effects of stimulus specificity and variety and
      the simultaneous reduction of variety for high energy density foods on short (within meal)
      and long-term (across meal) habituation. The second phase is designed to implement a series
      of field studies that will extend basic research from the first phase as well as define the
      optimal interval for reducing variety to facilitate long-term habituation to high energy
      density foods in the natural environment. The third phase is designed to develop and pilot
      test a family-based behavioral intervention for children that incorporates findings from
      phase2 into a clinical intervention.
    

Intervention name(s): Variety Group; Nutrition Education Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention will consist of our traditional family based weight control intervention with elements of reducing variety of high energy dense foods for the variety group.; The intervention will consist of our traditional family based weight control intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Safety and Effectiveness Study of a Closed Loop System Maintaining Patients' Glucose Levels During an Overnight Period
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Currently, patients diagnosed with type 1 diabetes rely on either finger stick or sensor
      glucose readings when making their insulin dosage decisions. Designing a computerized system
      that mimics the way insulin is produced naturally in a person who does not have type 1
      diabetes holds many challenges; all of which cannot be addressed in just one study. The
      purpose of the Medtronic Overnight Closed Loop study is to assess the performance of a system
      designed to automatically infuse the correct insulin dose during the hours that the patient
      is sleeping.

      The system consists of an insulin pump that provides insulin to the patient through an
      infusion set. A sensor inserted just under the patient's skin measures glucose levels and a
      transmitter sends this information to the pump. To enable the sensor to register the glucose
      information correctly, it must be set (calibrated) by a finger stick blood glucose 3-4 times
      a day. In the commercially released system, the physician would recommend the continuous
      background (basal) insulin rates and the patient would be required to make decisions
      regarding extra insulin (bolus) for meals or as a response to high glucose levels.

      In the Closed Loop System, a mobile control system is added to these devices. This consists
      of an Android phone, a closed loop algorithm and a translator. This system is designed to
      translate the sensor information and direct the pump to provide the required dosage of
      insulin automatically without requiring input from the patient.

      Reliable calibration has proved challenging, and so it is important that the system function
      safely, even when calibration is inaccurate. In this study, a calibration error will be
      introduced under very controlled circumstances. This testing will identify if the system can
      maintain acceptable overnight glucose levels, regardless of whether or not calibration is
      ideal.
    


Intervention name(s): Closed Loop Procedure (Medtronic)
Intervention type(s): Device
Intervention description(s): The procedure A is the device running under normal conditions, procedure B will incorporate an induced calibration error.
Other intervention name(s): AAGC
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: United Kingdom Overnight closed loop
Study Evaluating SKI-606 Administered to Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Safety and tolerability of SKI-606 in healthy subjects; the influence of food intake on the
      same.
    


Intervention name(s): SKI-606
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Effects of Marijuana on Symptoms of OCD
Condition: Obsessive-Compulsive Disorder
MeSH terms: Marijuana Abuse; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this pilot research study is to test whether certain components of the
      marijuana plant, known as "cannabinoids", may help to reduce symptoms in patients with OCD.
      Specifically, patients enrolled in the study will smoke marijuana containing different
      concentrations of 2 different cannabinoids, THC and CBD. Both of these agents act on the
      brain's "endocannabinoid system," which has been hypothesized to play a role in OCD. Neither
      compound is currently FDA-approved for treating OCD.
    

Detailed description: 
      Prior research suggests that certain areas of the brain are receptive to chemicals like those
      found in the cannabis (marijuana) plant, known as cannabinoids, and that these regions may be
      involved in anxiety disorders and OCD. More recent data shows that synthetic drugs that
      target these systems may be helpful in conditions related to OCD like anxiety disorders and
      Tourette's syndrome. Thus, these substances could also possibly be useful to treat OCD
      symptoms. However, to date there has been little research regarding the role of cannabinoids
      in OCD.

      The purpose of this study is to examine the effects of different cannabinoids on OCD symptoms
      in humans. To accomplish this in a laboratory setting, patients with OCD who are also
      occasional cannabis users will receive different combinations of two of the most well-studied
      cannabinoids, delta-9-tetrahydrocannabinol (THC, the main psychoactive component in cannabis)
      and cannabidiol (CBD, another component of the cannabis plant). We will then measure acute
      effects on OCD symptoms, anxiety, intoxication, and cardiovascular outcomes (i.e. blood
      pressure and heart rate).
    

Intervention name(s): Cannabis; Placebo
Intervention type(s): Drug; Other
Intervention description(s): THC and CBD are "cannabinoids" which are found naturally in the marijuana plant. Both act on the brain's "endocannabinoid system," which has been hypothesized to play a role in OCD.; Placebo control group, not receiving THC or CBD.
Other intervention name(s): marijuana
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: OCD; Marijuana; THC; Cannabis; CBD; Cannabinoid