bioihbjkbjnl/mcl2 huggingface dataset:
Ghrelin Resistance in Adolescents With Idiopathic Scoliosis
Condition: Scoliosis
MeSH terms: Scoliosis
Study type: Interventional

Summary: 
      Adolescent idiopathic Scoliosis (AIS) is the most common spine pathology. It is opposed to
      secondary scoliosis due to chronic diseases. Many hypotheses have been made to elucidate the
      origin of this illness. Recently, the melatonin pathway has been investigated as pinealectomy
      of the chicken creates a scoliosis that resembles AIS and melatonin supplementation reverses
      the process. In addition administration of melatonin to AIS patients improved the pathology.
      However this hypothesis has shown controversial results. Recent studies have demonstrated
      melatonin cellular resistance in osteoblastic cells from AIS patients. Melatonin acts through
      G protein coupled receptor (GPCR), mainly using the Gi pathway. In AIS osteoblasts, this
      pathway is blocked leading to a decrease in the inactivation of the adenylyl cyclase and
      therefore maintenance of high level of cyclic adenosine monophosphate (cAMP) concentrations
      in the cells. As modulation of cAMP is important for osteogenesis such resistance may be
      critical for the initiation or the development of AIS.

      Gi signalization is used by several other GPCR, thus, this hormonal resistance could
      logically be found in other hormonal or mediator pathways. A precedent study previously
      focused on ghrelin in AIS, and demonstrated that AIS patients possess elevated plasmatic
      values of ghrelin. This study also observed decreased response to ghrelin in AIS cultures
      osteoblasts.
    


Intervention name(s): Osteoblast sample
Intervention type(s): Biological
Intervention description(s): culture osteoblasts obtained from vertebrae fragments from 30 patients with AIS and from 10 control patients with secondary scoliosis
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Adolescent idiopathic Scoliosis; Ghrelin
The Effect of Depth of Anesthesia as Measured by Bispectral Index (BIS) on Emergence Agitation in Children
Condition: Emergence Agitation
MeSH terms: Psychomotor Agitation; Emergence Delirium
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether depth of anesthesia has an effect on
      emergence agitation (EA) in children age 2 - 8 years old. EA is a common problem in pediatric
      patients who receive general anesthesia with inhaled anesthetics, and the effect of depth of
      anesthesia on EA has not been studied. The study will randomize 40 children undergoing
      ophthalmologic surgery under general anesthesia to either light anesthesia (BIS 55-60) or
      deep anesthesia (BIS 40-45). EA will be measured by the peak Pediatric Assessment of
      Emergence Delirium (PAED) score in the recovery room, which rates agitation behaviors on a
      scale of 0 - 20. The hypothesis is that light anesthesia is associated with more EA.
    


Intervention name(s): Depth of anesthesia
Intervention type(s): Other
Intervention description(s): The intervention in this study is the titration of the depth of anesthesia according to the BIS monitor, as maintained by a combination of routine anesthetic agents (nitrous oxide, sevoflurane, and fentanyl).
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Keywords: Emergence delirium; Bispectral Index; Depth of anesthesia
Phase 1, Febuxostat XR Relative Bioavailability Study
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the relative bioavailability, safety and tolerability following
      administration of 80 mg single oral doses of 4 febuxostat extended release (XR) formulations.
    

Detailed description: 
      The drug being tested is this study is febuxostat XR. Four different formulations of
      febuxostat XR are being tested to see how the drug moves through the body. This study will
      look at safety and side effects in people who take febuxostat XR.

      This cross-over study will enroll approximately 78 patients. Participants will be randomly
      assigned to 1of 4 sequences which will determine the order of the 4 treatments received:

        -  Febuxostat XR 80 mg capsule Formulation 1

        -  Febuxostat XR 80 mg capsule Formulation 2

        -  Febuxostat XR 80 mg capsule Formulation 3

        -  Febuxostat XR 80 mg capsule Formulation 4

      Participants will take 1 dose on Day 1 with a washout period between each period.

      This single-center trial will be conducted in the United States. The overall time to
      participate in this study is up to 80 days. Participants will make multiple visits to the
      clinic including a period of confinement, and will be contacted by telephone 30 days after
      last dose of study drug for a follow-up assessment.
    

Intervention name(s): Febuxostat XR 80 mg Capsule F1; Febuxostat XR 80 mg Capsule F2; Febuxostat XR 80 mg Capsule F3; Febuxostat XR 80 mg Capsule F4
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Febuxostat extended-release (XR) capsules formulation 1; Febuxostat XR capsules formulation 2; Febuxostat XR capsules formulation 3; Febuxostat XR capsules formulation 4
Intervention MeSH terms: Febuxostat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Drug therapy
Bioavailability of Four Oral Prototype Extended Release Formulations With BI 11634 in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the oral bioavailability and rate of absorption of four prototype extended-release
      (ER) formulations with BI 11634 (single doses) to immediate-release (IR) tablets in healthy
      male volunteers.
    


Intervention name(s): BI 11634 ER formulation A; BI 11634 ER formulation B; BI 11634 ER formulation M; BI 11634 ER formulation C; BI 11634 IR tablet
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Peginterferon Plus Ribavirin Combination Therapy for Hepatitis C Six Months After Onset of Acute Infection
Condition: Acute Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients with acute hepatitis C virus (HCV) infection usually become chronicity if viremia
      persists after 6 months of infection. The result of using pegylated interferon plus ribavirin
      combination therapy upon these patients remains to be explored
    

Detailed description: 
      Combination therapy with pegylated interferon-alpha plus ribavirin has greatly improved the
      treatment efficacy and is the mainstream of treatment for chronic hepatitis C infection.
      Current guideline suggests pegylated interferon monotherapy for patients with acute HCV
      infection. The efficacy might greatly improves if the treatment starts earlier. An estimation
      of 20 percents of patients could recover from acute infection spontaneously within 6 months
      after exposure,however. The present study aims to clarify the efficacy of pegylated
      interferon and ribavirin combination therapy for patients with hepatitis C six months after
      onset of acute infection
    

Intervention name(s): pegylated interferon alpha 2a, ribavirin
Intervention type(s): Drug
Intervention description(s): pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 24 weeks, follow up for 24 weeks
Other intervention name(s): PEGASYS®
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acute hepatitis C; treatment; SVR
Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Subjects With Atopic Dermatitis
Condition: Pruritus; Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema; Pruritus
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter, randomized, double-blind, 4-arm, placebo-controlled study to evaluate
      the efficacy and safety of twice-daily (BID) oral difelikefalin (CR845) in adult subjects
      with atopic dermatitis (AD) and moderate to severe pruritus.
    

Detailed description: 
      The study will consist of a 30-day Screening period, a 7-day Run-In period, a 12-week
      Placebo-Controlled Treatment period followed by a 4-week Active Extension period and a Follow
      Up visit approximately 7 days after the last dose of study drug.

      All subjects will sign an informed consent form (ICF) and undergo screening for study
      eligibility.

      Subjects will be randomized to receive either placebo or difelikefalin (CR845) tablets at a
      dose of 0.25 mg, 0.5 mg, or 1.0 mg, orally BID. Intake of the first dose of study drug will
      be at Day 1.

      Subjects who complete the Placebo-Controlled Treatment period of the study will transition
      into the Active Extension upon completion of the Week 12 visit assessments. All subjects in
      the Active Extension will receive difelikefalin (CR845).
    

Intervention name(s): difelikefalin 0.25 mg; difelikefalin 0.5 mg; difelikefalin 1.0 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral difelikefalin 0.25 mg administered twice daily; Oral difelikefalin 0.5 mg administered twice daily; Oral difelikefalin 1.0 mg administered twice daily; Oral Placebo administered twice daily
Other intervention name(s): CR845; CR845; CR845
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Atopic Dermatitis; Pruritus; CR845; Chronic Itch; difelikefalin; Itch; Itching; Generalized pruritus; Eczema
Safety, Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants (V114-028)
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V114
      administered subcutaneously or intramuscularly in healthy Japanese infants (3 months of age).
    


Intervention name(s): V114; Pneumococcal 13-valent Conjugate Vaccine (PCV13); Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio (Sabin strain) Combined Vaccine (DTaP-IPV)
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.; 13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F, serotype 6B in each 0.5. mL dose.; Single SC dose of 0.5 mL at Visits 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age).
Other intervention name(s): VAXNEUVANCE™; Pneumococcal 15-Valent Conjugate Vaccine; PREVNAR 13®
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Pneumococcal Vaccines
Muscle Activity of the Upper Limb Between Task-Specific and Robot Assisted Training Among Individuals Post Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Observational

Summary: 
      The investigators compared the activity and fatigue of upper extremity muscles, pain levels,
      subject satisfaction levels, perceived exertion, and number of repetitions in Task-Specific
      Training (TST) compared with Robot-Assisted Training (RAT) in individuals post-stroke.
    

Detailed description: 
      Twenty sub-acute post stroke subjects received one TST and one RAT. They marked the pain
      level in their paretic extremity before and after each session. Muscle activity levels and
      fatigue and number of repetitions were monitored during each session. The subjective
      assessment questionnaire of treatment and the Borg scale were administered post-session.
    

Intervention name(s): The RAT and The TST
Intervention type(s): Diagnostic Test
Intervention description(s): The RAT (ReoGo; Motorika Medical, Caesarea, Israel) The TST protocol included the conventional, repetitive, task-oriented training of the affected arm.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        stroke survivors
The Phase II Study of Bardoxolone Methyl in Patients With Chronic Kidney Disease and Type 2 Diabetes; TSUBAKI Study
Condition: Chronic Kidney Disease; Type 2 Diabetes
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety and efficacy of RTA 402 in chronic kidney
      disease (CKD) patients with type 2 diabetes in a double-blind, placebo-controlled study when
      this compound is administered once daily for 16 weeks in an intrapatient dose escalation
      design.
    


Intervention name(s): RTA 402; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetic Nephropathies; Kidney Diseases; Renal Insufficiency, Chronic; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Renal Insufficiency; Urologic Diseases; bardoxolone methyl
Motivational Interviewing With Dyslipidemic Adolescents Together With a Parent Versus With Adolescents Alone: A Mixed Methods Clinical Trial
Condition: Dyslipidemias
MeSH terms: Dyslipidemias
Study type: Interventional

Summary: 
      The primary focus of this proposal is to address growing concern of overweight/ obese
      adolescents with hyperlipidemia. The proposed study is a 2-arm randomized controlled clinical
      trial to compare the effectiveness of Motivational interviewing (MI) interventions with the
      parent and adolescent dyad versus adolescent (10-17yr) alone. The patients will be recruited
      from the Lipid clinic at Sick Kids. The study hypothesis is that parent child dyad will have
      more success due to the possible synergetic effect compared to adolescents alone. The study's
      primary outcome is cholesterol levels (Triglycerides/HDL ratio) and secondary outcomes
      include overall improvement in their lifestyle and their responses to the MI intervention.
    


Intervention name(s): Motivational Interviewing/Counselling
Intervention type(s): Other
Intervention description(s): Motivational Interviewing/Counselling
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Motivational Interviewing
Procaspase Activating Compound-1 (PAC-1) in the Treatment of Advanced Malignancies - Component 1
Condition: Solid Tumor; Pancreatic Neuroendocrine Tumor; Neuroendocrine Tumors
MeSH terms: Neoplasms; Neuroendocrine Tumors
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase I dose escalation study will evaluate Procaspase Activating Compound-1 (PAC-1), a
      small molecule that activates procaspase -3 to caspase-3, resulting in apoptosis of cancer
      cells, in patients with advanced malignancies. As of March 1, 2019, only patients with
      neuroendocrine tumors will be enrolled in Component 1 of this study. PAC-1 is taken orally on
      days 1-21 of a 28-day cycle. The maximum tolerated dose (MTD) of PAC-1 (5 dose levels) will
      be determined using a modified-Fibonacci dose-escalation 3+3 design. Treatment continues
      until disease progression, unacceptable toxicity, physician discretion, or patient refusal.
    


Intervention name(s): PAC-1
Intervention type(s): Drug
Intervention description(s): PAC-1 is taken orally on days 1-21 of a 28-day cycle.
Other intervention name(s): Procaspase Activating Compound-1
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: refractory; intolerant; solid tumors; PNET; neuroendocrine
Treatment of Bulimia Nervosa in a Primary Care Setting
Condition: Bulimia Nervosa
MeSH terms: Bulimia; Bulimia Nervosa
Study type: Interventional

Summary: 
      Bulimia Nervosa is a frequent problem for young women. It is widely assumed that this
      disorder cannot be treated effectively in a primary care setting. This assumption has never
      been tested empirically, and is probably incorrect.

      In the last 15 years, effective treatment interventions for Bulimia Nervosa have been
      developed and validated in specialized treatment centers. The broad aim of this proposal is
      to examine whether these treatments, suitably adapted, can be usefully transferred to general
      health care settings. Specifically, the proposed study will determine the relative and
      combined effectiveness of the two leading treatments for Bulimia Nervosa in a primary care
      setting. The two major interventions are treatment with an antidepressant medication,
      fluoxetine, and with a form of cognitive behavioral therapy, guided self-help, designed for
      use in primary care.
    


Intervention name(s): Fluoxetine; Guided Self-Help
Intervention type(s): Drug; Behavioral
Intervention MeSH terms: Fluoxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Primary Care; Fluoxetine
Sleep Device Testing
Condition: Insomnia Chronic
Study type: Interventional

Summary: 
      Infants often have sleep challenges. Most of these challenges in otherwise healthy children
      and due to behavioral insomnia. The goal for infants is to become independent sleepers by
      learning the process of self-soothing. This study hopes to determine if technology based on
      sensors is able to help teach self-soothing to infants.
    


Intervention name(s): Sleep sensor technology
Intervention type(s): Device
Intervention description(s): Infants will sleep on a novel device with built-in sensor technology that tracks sleep patterns and provides output based on historical sleep data.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Kinesio Taping and Dry Needling in Grade 1, 2 Knee Osteoarthritis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      This study's aim was:

      - To determine the effects of kinesio taping and dry needling on pain, ROMs, functional
      mobility, and quality of life in knee OA patients.
    

Detailed description: 
      This was a randomized clinical trial in which Grade 1, 2 Knee Osteoarthritis patients were
      randomized into two groups: Group-A and Group-B. Group-A participants received Kinesio taping
      while Group-B participants received dry needling as an adjunct to the conventional physical
      therapy treatment. The intervention was carried out for four weeks with frequency of two
      sessions per week. Outcome measures were assessed at baseline, after two weeks, and after 4
      weeks, using Visual Analog Scale (VAS), Western Ontario and McMaster Universities
      Osteoarthritis Index (WOMAC), Knee Range of Motion (ROM), and SF-12 Quality of Life
      Questionnaire.
    

Intervention name(s): Kinesio Taping; Dry Needling
Intervention type(s): Other; Other
Intervention description(s): One Y-shaped strap with 25% stretch was applied from the mid third of the thigh over the rectus femoris, then its ends directed toward the tibial tuberosity by enwrapping the patella from lateral and medial sides. In 45° knee flexion one eye strap from medial to lateral was applied through the collateral medial and lateral ligaments.
For the facilitation of VMO 1 eye strap with 25% stretch from medial aspect of thigh to quadriceps tendon. Lastly, 1 eye strap with 25% stretch from tibial tuberosity to lateral aspect of thigh for inhibition of Vastus lateralis; Following a protocol according to patient and limb, the tensor fasciae latae, hip adductors, hamstrings, quadriceps, gastrocnemius, and popliteus muscles were properly examined in each subject. These muscles are frequently involved in muscle-related knee pain.
Patients with knee OA who had at least one active MTrP that produced pain were recruited. Patients received a total of 8 DN sessions (2 sessions per week for 4 weeks) at all MTrPs of the lower limbs using the fast-in and fast-out technique (the needle was moved up and down within the muscle).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Concurrent Parallel Randomized Clinical Trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dry Needling; Joint Flexibility; Kinesio Tape; Knee Osteoarthritis; Pain; Quality of Life
Phosphate Bioavailability Hormonal Response to a Breakfast Meal in Healthy Humans
Condition: Phosphate Overload
Study type: Interventional

Summary: 
      Convenience food is enhanced with phosphate additives in order to modify taste and texture
      and for preservation. The purpose of this study is to measure the response of
      phosphate-related hormones to two different types of breakfast meals that contain the same
      amount of phosphate but in different forms. This study is a cross-over design.
    

Detailed description: 
      In the first meal, the participant will consume a standard convenience breakfast meal
      comprised of a cheese tea biscuit and two Eggo waffles. The amount of phosphorus contained in
      this meal is 700 mg and the majority of this phosphate would be in the form of phosphate
      additives. Urine and blood will be collected before and after consumption of the meal to
      measure how the body responds to the meal. Specifically, levels of phosphate, calcium,
      creatinine (measure of kidney function) and three hormones involved in phosphate regulation
      (parathyroid hormone, fibroblast growth factor-23 and vitamin D) will be measured in each
      blood sample. Creatinine, calcium and phosphate will be measured in each urine sample. The
      second meal will also contain 700 mg of phosphorus and similar caloric content but in a
      healthy breakfast meal that does not contain any phosphate additives, consisting of one cup
      of All-Bran breakfast cereal with milk and a piece of fruit. The same blood and urine tests
      will be assessed after the second meal.
    

Intervention name(s): Meal
Intervention type(s): Other
Intervention description(s): Comparison of two breakfast meals containing the same amount of phosphorus but one in the form of inorganic additives
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: cross-over design
Masking: None (Open Label)
Primary purpose: Other