bioihbjkbjnl/mcl2 huggingface dataset:
Novel Measure of Social Deficits in Children
Condition: Autism Spectrum Disorders; ADHD
MeSH terms: Autism Spectrum Disorder
Study type: Observational

Summary: 
      Autism Spectrum Disorders (ASD) feature impairments in social interaction and communication.
      Drug and behavioral treatments for ASD are undergoing rapid development, yet our diagnostic
      tools are not suitable for efficacy assessment. The Autism-Diagnosis Observational Schedule
      (ADOS) is a clinical interview with the child and the gold standard for diagnosis. However,
      this test is subjective, course grained and costly, precluding repeated tests of the same
      child to assess treatment efficacy and large-scale control assessments of typically
      developing (TD) children. For these reasons, the ADOS can impede imaging and genetic
      research.

      In light of these concerns, the Oregon Animation Test for Social Reciprocity (OATS) will be
      developed to evaluate distinct autistic behavioral phenotypes, including joint attention,
      empathy, imitation, and lack of narrative coherence. The main idea of OATS is that animated
      characters and social scenarios are presented on a computer screen while the responses of the
      child are recorded by video camera, microphone, and eye-tracking equipment. Animations are
      used to test each behavioral phenotype of autism. The long-term vision for OATS is to
      evaluate behavioral and physiological responses of autistic children, including heart rate
      variability, pupil dilation, and EEG. Our first objective is to use existing animations to
      build an OATS "Prototype" that discriminates autistic from normal children (Aim 1). From
      these results, and use of a defined library of still frame posed images, we will design our
      own animation platform to assess differences between autistic and normal children (Aim 2).
    

Detailed description: 
      Please see the brief summary above.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children 6-11 years of age with autism, ADHD, or typical, with and IQ exceeding 70.
      
Keywords: autism; ADHD; attention deficit hyperactivity disorder; behavioral assessment; behavior
Trial Investigating the Absorption, Metabolism and Excretion After a Single Subcutaneous Dose of [3H]-Semaglutide in Healthy Male Subjects
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of the trial is to investigate the absorption,
      metabolism and excretion after a single subcutaneous dose of [3H]-semaglutide in healthy male
      subjects.
    


Intervention name(s): semaglutide
Intervention type(s): Drug
Intervention description(s): Subjects will receive a single dose subcutaneously (s.c., under the skin).
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Tramadol iv. : Influence of Dose and Dose Intervals on Therapeutic Accuracy and Side Effects When Used for Postoperative Pain Relief in Ambulatory Surgery
Condition: Ambulatory Surgery
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to compare the administration of 1 unit dose of 100 mg tramadol
      intravenously versus multiple smaller dosages of tramadol during the first 6 hours
      post-operatively and to investigate the time course and accuracy of pain relief versus the
      onset and duration of side-effects.
    


Intervention name(s): Administration of tramadol intravenously
Intervention type(s): Drug
Intervention MeSH terms: Tramadol
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Pexidartinib in Participants With Moderate Hepatic Impairment Compared With Healthy Participants
Condition: Moderate Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The pharmacokinetics of a single dose of pexidartinib was investigated in participants with
      impaired hepatic function and compared with healthy control participants with normal hepatic
      function.
    

Detailed description: 
      Pexidartinib is an orally administered tyrosine kinase inhibitor, currently approved in the
      US for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT)
      associated with severe morbidity or functional limitations and not amenable to improvement
      with surgery.

      The primary objective of this study is to determine the plasma pharmacokinetics (PK) of
      pexidartinib after a single oral dose of 200 mg in participants with moderate hepatic
      impairment (HI) as defined by National Cancer Institute Organ Dysfunction Working Group
      (NCI-ODWG) criteria compared to the healthy controls participants with normal hepatic
      function.
    

Intervention name(s): Pexidartinib
Intervention type(s): Drug
Intervention description(s): Single, 200-mg capsule will be administered orally on Day 1 with 240 mL of water, following an overnight fast of at least 10 hours.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Moderate hepatic impaired; Healthy subjects; Pexidartinib; Clinical pharmacology study; Tenosynovial giant cell tumor (TGCT)
A Study To Investigate The Safety, Toleration And Pharmacokinetics Of Single Oral Doses Of PF-03864086 In Healthy Male Subjects
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety and tolerability of PF-03864086 in
      healthy male human volunteers. Determine the pharmacokinetics (calculations of the rate of
      elimination of PF-03864086 from the body once the compound is ingested).
    


Intervention name(s): PF-3864086; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The dosage form is POS (powdered oral suspension). Each subject will have 5 periods and the frequency (and duration) is once per period. The doses have been left flexible within the protocol but are listed as: 3, 10, 30, 60, 120, 240, 480 and 720 mg with an option to insert an additional dose cohort as well.; Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: phase 1, human study, healthy volunteers
Trial to Evaluate the PK Profile of Glepaglutide (ZP1848) After a Single IV and After Multiple SC Injections in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the trial is to characterize the pharmacokinetic (PK) profiles of
      glepaglutide and its primary active metabolites following once-daily and once-weekly
      subcutaneous (SC) injections and after a single intravenous (IV) infusion in healthy
      subjects.

      Glepaglutide is a proposed International Nonproprietary Name for ZP1848
    


Intervention name(s): Glepaglutide
Intervention type(s): Drug
Intervention description(s): Solution for injection
Other intervention name(s): ZP1848
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Social Effects of Alcohol
Condition: Alcohol Drinking
MeSH terms: Alcohol Drinking
Study type: Interventional
Phase: Early Phase 1

Summary: 
      In this study the investigator will assess the effect of a moderate dose of alcohol on
      emotional responses and feelings of connection during a dyadic semi-structured social
      interaction
    

Detailed description: 
      The study will use a within-subject crossover design with four sessions, in which
      participants receive alcohol or placebo across sessions. During the four sessions, the
      participants will engage in a conversation with a stranger, and emotional responses and
      feelings of connection will be assessed.
    

Intervention name(s): Alcohol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Alcohol (0.8g/kg); Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Tolerability and Pharmacokinetics of Iloperidone in Adolescent Patients
Condition: Safety and Tolerability of Iloperidone
Study type: Interventional
Phase: Phase 1

Summary: 
      Tolerability, undertstanding of the action of the drug in the body, and understanding the
      effect of the drug in adolescent patients needing treatment with an antipsychotic medication
    


Intervention name(s): iloperidone (oral tablet)
Intervention type(s): Drug
Intervention description(s): iloperidone 12 to 24 mg/day followed by 26 weeks of flexible dosing (6 to 24 mg/day)
Intervention MeSH terms: Iloperidone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antipsychotic; Schizophrenia; Bipolar disorder; Iloperidone
A New Surgery Platform for Calcaneal Surgery: a Clinical Research
Condition: Calcaneus Fracture
Study type: Interventional

Summary: 
      Purpose: Study on the method of lateral nursing and surgical operating tables optimization in
      the calcaneal surgery.

      Method:Design combined surgical operating tables grouped according to the time of clinical
      application.58 patients with lateral calcaneus surgeries are divided into the control group
      of 29 patients and the experimental group with 29 patients. The traditional lateral method
      and calcaneus lateral surgery platforms are separately applied to compare the sliding of the
      affected limb during a surgery, the stability of the position, the difference of the surgical
      instruments fall and the satisfaction of the medical staff.Moreover,30 healthy volunteers are
      selected to experience the comfort level of the two placement methods.
    


Intervention name(s): different types of surgery platforms
Intervention type(s): Procedure
Intervention description(s): 58 patients with lateral calcaneus surgeries are divided into the control group of 29 patients and the experimental group with 29 patients. The traditional lateral method and calcaneus lateral surgery platforms are separately applied in the groups.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Growth Response in Short Children Suffering From a Disease With Growth Retardation and Treated With Somatropin
Condition: Idiopathic Short Stature
MeSH terms: Dwarfism
Study type: Interventional
Phase: Phase 2

Summary: 
      Growth hormone therapy will improve the height of short statured children with pathological
      conditions that lead to growth retardation. Growth hormone therapy will show an increase in
      height velocity >1 SD compared to pretreatment height velocity. and the therapy will be safe.
    

Detailed description: 
      Growth hormone (GH, Somatropin, e.g. Genotropin®) is approved in the treatment of children in
      specific indications. However, besides the benefit in approved indications, a benefit can
      also be achieved in other pathological conditions that lead to growth retardation. However,
      because of their relative low frequency and the long duration of GH studies in children, few
      data or only case reports on GH treatment are available in these conditions. Nevertheless,
      published data have suggested a benefit of GH treatment in children suffering from some of
      those diseases and pediatric endocrinologists sometimes request GH treatment for those
      children to improve growth rate. This protocol is designed to allow such children with severe
      growth retardation to be treated with GH and will allow those children to be carefully
      followed-up and finally evaluated at the end of the GH treatment period.
    

Intervention name(s): somatropin (Genotropin® treatment)
Intervention type(s): Drug
Intervention description(s): 0,035 mg /kg bodyweight of Somatropin per day given by subcutaneous injections through an injection device (GenotropinPEN)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: short stature
A Multicenter, Double Blinded, Randomized, Parallel Assignment Study to Demonstrate the Efficacy of DA9601
Condition: NSAID-associated Gastroduodenal Injury
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a phase IV clinical study to evaluate the preventive effectiveness of
      NSAID-Associated Gastroduodenal Injury. The study is consisted of multi-center, doubleblind,
      active-controlled, stratified randomized, parallel group. A tablet of DA9601, Cytotec (200ug
      of Misoprostol), Acrofen (100mg of Aceclofenac) will be assigned randomly to the subjects for
      four weeks.
    

Detailed description: 
      After filling an Informed consent form, subjects are joined the clinical trials. First of
      all, Screening test including the endoscopy test is performed.

      Subjects, which fit the inclusion/Exclusion criteria, are assigned randomly. Subjects takes
      investigation products as randomized.
    

Intervention name(s): Stillen; Cytotec (reference drug); NSAID (Aceclofenac)
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Aceclofenac; Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Study of the TransPyloric Shuttle™ (TPS™) for Weight Reduction in Obese Subjects
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      The purpose of this study is to assess the feasibility of the TransPyloric Shuttle™ (TPS™)
      when used to treat obesity.
    

Detailed description: 
      The number of people who are overweight or obese has been steadily rising. In Australia, in
      1980, 8.3% of the population was considered obese. By 2010, the Australian obesity rate had
      risen to 24.8%.

      Weight loss significantly decreases early mortality as well as the development of new
      health-related conditions in obese subjects, and can improve many of the co-morbidities
      associated with obesity.

      Therapies include drugs, surgery and treatment with medical devices, such as gastric banding
      and intragastric balloons. The TransPyloric Shuttle™ (TPS™) is a medical device that is
      endoscopically delivered and removed from the stomach. The TPS™ is designed to self-position
      across the pylorus and create an intermittent obstruction to outflow that may result in
      delayed gastric emptying. Slowing gastric emptying may enable an overall reduction in caloric
      intake by helping the subject feel full sooner (early satiation) and/or feel full longer
      (prolonged satiety/reduced hunger).
    

Intervention name(s): BAROnova™ TransPyloric Shuttle™ (TPS™)
Intervention type(s): Device
Intervention description(s): Subjects will undergo an endoscopic procedure to deliver the TPS™ into the stomach. The TPS™ moves freely without any physical attachment or invasive anchoring to tissue to reduce gastric outflow.
Other intervention name(s): ENDObesity I Study™; BAROnova™; TransPyloric Shuttle™; TPS™
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity
Postprandial Glucose, Insulin Response to Meal Sequence Among Healthy UAE Adults
Condition: Postprandial Hyperglycemia
MeSH terms: Hyperglycemia
Study type: Interventional

Summary: 
      the goal of this Randomized controlled cross over trial is to compare the effects of meal
      sequences VPF meal vs. SMM on the incremental area under the curve of postprandial glucose
      response among healthy adults in the UAE. the main question it aims to answer is what is the
      effect of meal sequence of vegetable and protein first followed by carbohydrates (VPF)
      compared to a standard mixed meal (SMM) on the postprandial glucose level and insulin
      response among healthy adults in the UAE. Participants will consume two is caloric test meals
      in random order (SMM and VPF meal sequences) separated by a 7-10-day washout period then
      blood sample will be collected at fasting ,30min,60min and 120mon for glucose and insulin and
      hunger ration will be done as well .Researchers will compare the effect of the two meals on
      postprandial blood glucose, insuline and hunger rating.
    


Intervention name(s): vegetable and protein first followed by carbohydrates (VPF) meal sequence
Intervention type(s): Other
Intervention description(s): vegetable and protein first followed10 min later by carbohydrates (VPF) meal sequence
Other intervention name(s): VPF
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
A 24-Week Study of Topical Pirenzepine or Placebo in Type 2 Diabetic Patients (T2DM) With Peripheral Neuropathy
Condition: Peripheral Neuropathy; Painful Diabetic Neuropathy; Diabetic Neuropathies, Painful
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies; Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized outpatient, double-blind, placebo-controlled, multiple-site study of the
      safety, tolerability, and exploratory efficacy of topically administered WST-057 (4%
      pirenzepine free base monohydrate) for 24 weeks in subjects with T2DM with peripheral
      neuropathy.
    

Detailed description: 
      This is a randomized outpatient, double-blind, placebo-controlled, multiple-site study of the
      safety, tolerability, and exploratory efficacy of topically administered WST-057 (4%
      pirenzepine free base monohydrate) for 24 weeks in subjects with T2DM with peripheral
      neuropathy. Subjects will attend visits at screening (day -45 to -28); day 1 (baseline);
      weeks 2, 4, 8, 12, 16, 20, 24; and follow-up (week 26). Approximately 60 subjects with T2DM
      with peripheral neuropathy will be randomized to 1 of 4 treatment groups in a 1:1:4:4 ratio:
      placebo control 2 mL (n = 6 subjects), placebo control 4 mL (n = 6 subjects); low dose (2 mL)
      WST-057 (73 mg pirenzepine free base monohydrate) (n = 24 subjects); and high dose (4 mL)
      WST-057 (146 mg pirenzepine free base monohydrate) (n = 24 subjects), with the assumption
      that a total of 50 subjects will complete the study.

      This study is designed with 4 periods: screening, baseline/day 1, outpatient treatment, and
      safety follow-up.
    

Intervention name(s): WST-057 (4% pirenzepine) Lose Dose 2mL; WST-057 (4% pirenzepine) High Dose 4mL; Placebo Low Dose; Placebo High Dose
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Topical Solution; Topical Solution; Topical Solution; Topical Solution
Intervention MeSH terms: Pirenzepine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes Mellitus
Bone Marrow Derived AC 133+ and Mono-Nuclear Cells (MNC) Implantation in Myocardial Infarction (MI) Patient
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Although a percutaneous coronary intervention (PCI) can be used to open up the blocked artery
      and restore blood flow to the heart muscle after myocardial infarction, there may be a
      significant amount of heart tissue that has been irreversibly damaged. Recent studies have
      shown that adult stem cells from bone marrow may be able to improve heart function and
      prevent from heart remodeling due to heart failure.

      This study will evaluate the safety and effectiveness of using adult bone marrow derived stem
      cells for improving heart function in MI patients with Left Anterior Descending (LAD)
      involvement.
    

Detailed description: 
      Patient from both gender, who had acute MI within recent 3 Weeks in LAD territory and would
      underwent PCI are eligible for this study. The bone marrow derived AC 133+ and MNC would be
      intracoronary injected to the patients during PCI procedure. The control group would be
      received just serum during PCI. The patient would be followed every month and at the end of
      6th and 18thmonth the case and control groups will be evaluated by stress echo and Tc99 scan.

      The totality of evidence from trials investigating autologous whole bone marrow infusion into
      patients following myocardial infarction supports the safety of this approach in terms of
      efficacy
    

Intervention name(s): AC133; MNC; CONTROL
Intervention type(s): Biological; Biological; Biological
Intervention description(s): intra coronary injection of bone marrow derived AC133+ cells; intra coronary injection of bone marrow derived MNC; autologous serum injection
Other intervention name(s): AC133 injection; MNC injection; placebo injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: myocardial infarction; bone marrow stem cell; AC133; mono nuclear cell
A Study to Evaluate the Pharmacokinetics (Drug Levels and Metabolism), Safety, and Tolerability of BMS-986259 in Participants With Various Levels of Kidney Function
Condition: Renal Failure
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to evaluate the drug effect, safety, and tolerability of BMS-986259 in participants
      with different levels of kidney function
    

Detailed description: 
      Recruitment temporarily on hold due to COVID-19
    

Intervention name(s): BMS-986259
Intervention type(s): Drug
Intervention description(s): Specified Dose on Specified Days
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of PBI-200 With Ritonavir or Cobicistat in Healthy Volunteers
Condition: Drug-drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a drug-drug interaction study in volunteers to evaluate the effect of ritonavir or
      cobicistat on the pharmacokinetics (PK) of PBI-200.
    

Detailed description: 
      This is an open-label, single-sequence, three-period drug-drug interaction study in healthy
      male and female volunteers to evaluate the effect of a potent CYP3A inhibitor, ritonavir or
      cobicistat, on the single dose PK of orally administered PBI-200. It is expected that
      co-administration of ritonavir or cobicistat with PBI-200 will increase the exposure of PBI
      200.
    

Intervention name(s): PBI-200 Tablet; Ritonavir Oral Tablet; Cobicistat Oral Tablet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): PBI-200 is a TRK inhibitor; Ritonavir is a potent CYP3A inhibitor; Cobicistat is a potent CYP3A inhibitor
Other intervention name(s): Norvir; Tybost
Intervention MeSH terms: Ritonavir; Cobicistat
Intervention model: Single Group Assignment
Intervention model description: Single-sequence, three-periods
Masking: None (Open Label)
Primary purpose: Treatment