bioihbjkbjnl/mcl2 huggingface dataset:
DIR/ Floortime™ Parent Training Intervention for the Children With Developmental Disabilities
Condition: Cerebral Palsy; Down's Syndrome; Delayed Development
MeSH terms: Cerebral Palsy; Down Syndrome; Developmental Disabilities
Study type: Interventional

Summary: 
      The objective of this study is to test whether adding the parent training program using the
      relationship-based approach could help the children with development disabilities (DDs) would
      confer additional benefits over routine clinical care available to both groups in terms of
      improving their development and reducing behavior problems.
    

Detailed description: 
      The objective of this study is to test whether adding the parent training program using the
      relationship-based approach could help the children with development disabilities (DDs) would
      confer additional benefits over routine clinical care available to both groups in terms of
      improving their development and reducing behavior problems.

      The study treatment involves intervention entirely with parents of children with DDs, rather
      than directly with the children themselves. Before the first session, all parents in the
      intervention group had to learn about DIR/ Floortime™ model approach through 1 - hour one on
      one coaching (at the beginning oft the study, the end of 1st and 3rd month) and through 2
      hours DVD lecture and a pocket book. The parent in the intervention group will be asked to
      carry out FloortimeTM together with using Floortime strategies during daily activities a
      minimum of 15 hour per week. Meanwhile, the children in the control groups will continue
      their routine care. The baseline assessment and follow up time schedule were similar to those
      of the intervention group.
    

Intervention name(s): Parent training; Routine care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): All parents in the intervention group had to learn about DIR/ Floortime™ model approach through one on one coaching (1 hour/ session for three sessions) and through 2 hours DVD lecture.; routine care
Other intervention name(s): DIR/ Floortime parent training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parent training; DIR/ Floortime Approach; Children with developmental disabilities
Incretin Action in Physiology and Diabetes
Condition: Insulin Secretion
Study type: Interventional
Phase: Phase 1

Summary: 
      This project is designed to advance understanding of the incretin effect in health and
      disease. This system of gut-islet linkage is essential for normal glucose tolerance, impaired
      in T2DM, and amenable to therapeutic intervention. However, there are important gaps in
      understanding incretin function that limit application of this system; this project will
      address several of these. A secondary, but critical aspect of this research is focus on
      inter-individual variation in the physiology of the incretin system. This is a novel
      direction for research in this field and is critical to advancing the concept of
      individualized medical care in diabetes by establishing whether there is a physiologic basis
      for predicting the existence of responders and non-responders to incretin therapies.

      Currently, we have described only Aim 1 from this grant in this protocol registration. While
      Aim 2 and 3 are described in the grant, Aim 1 will be conducted first and the results from
      this Aim and / or the publication of other results in the field may affect the approach to
      Aims 2 and 3.
    


Intervention name(s): GIP infusion; GLP-1 infusion; Ex-9 infusion
Intervention type(s): Drug; Drug; Drug
Intervention description(s): after establishing a hyperglycemic clamp (target: 125 mg/dL) GIP will be infused; after establishing a hyperglycemic clamp (target: 125 mg/dL) GLP-1 will be infused; Ex-9 infusion will be initiated at start of hyperglycemic clamp (target: 125 mg/dL)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Incretins; GLP-1; GIP; hyperglycemic clamp; Glucagon
A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD9977 After Single Ascending Doses to Healthy Males
Condition: Safety; Tolerability; Pharmacokinetics; Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be a randomized, single-blind, placebo-controlled first-in-human study in
      healthy male subjects to assess the safety, tolerability and pharmacokinetics of single
      ascending doses of AZD9977. In Part B of this study the regional absorption of AZD9977 along
      the gastro-intestinal tract will be investigated using the IntelliCap® system in a
      non-randomized, open-label, fixed-sequence design. The study will be performed at a single
      study centre.
    

Detailed description: 
      This study will be a randomized, single-blind, placebo-controlled first-in-human study in
      healthy male subjects to assess the safety, tolerability and pharmacokinetics of single
      ascending doses of AZD9977. In Part B of this study the regional absorption of AZD9977 along
      the gastro-intestinal tract will be investigated using the IntelliCap® system in a
      non-randomized, open-label, fixed-sequence design with oral solution as reference. The study
      will be performed at a single study centre.
    

Intervention name(s): AZD9977, oral suspension; Placebo, oral suspension; AZD9977, oral solution
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single ascending doses of AZD9977 oral suspension (Part A) Single dose of AZD9977 oral suspension in IntelliCap® capsule in regional absorption part (Part B); Matching placebo; AZD9977, single dose of oral solution in Part B as reference
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: AZD9977; Safety; Tolerability; Pharmacokinetics; First-in-human; Single Ascending Dose; Regional absorption; Healthy male subjects
Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk Open-label Extension
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary clinical hypothesis is that long-term exposure of evolocumab will be safe and
      well tolerated in subjects with clinically evident atherosclerotic cardiovascular disease
      (CVD).
    

Detailed description: 
      This is a multicenter, open-label extension study designed to assess the long-term safety of
      evolocumab in subjects who completed the FOURIER study,which is a randomized
      placebo-controlled study of evolocumab in subjects with clinically evident atherosclerotic
      CVD on stable effective statin therapy. Eligible subjects at sites participating in FOURIER
      OLE who have signed the FOURIER OLE informed consent may be enrolled at the completion of
      FOURIER study.
    

Intervention name(s): Evolocumab
Intervention type(s): Biological
Intervention description(s): subjects will receive evolocumab 140 mg every 2 weeks (Q2W) or 420 mg monthly (QM), according to the subject's preference.
Intervention MeSH terms: Evolocumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: High Cholesterol; Treatment for high cholesterol; Lowering cholesterol; Lowering high cholesterol; Hypercholesterolemia
Evaluation of Age-Related Skin Changes
Condition: Age-related Skin Changes
Study type: Observational

Summary: 
      This trial is a knowledge study utilizing skin measurement probes that are non-invasive
      instruments, with negligible risks for the subjects. No product will be studied.
    


Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        100 female subjects will be included, with at least 10 subjects per age decade
A Pilot Study to Characterize Bile Acid Metabolism and Dysbiosis in Primary Sclerosing Cholangitis
Condition: Primary Sclerosing Cholangitis; Inflammatory Bowel Disease
MeSH terms: Inflammatory Bowel Diseases; Cholangitis; Cholangitis, Sclerosing; Dysbiosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this study is to assess if oral vancomycin can restore the normal bile acid
      metabolism of people with Primary Sclerosing Cholangitis and Inflammatory Bowel Disease.
      Study participants will provide blood and stool samples in order to evaluate the bile acid
      metabolism before a short course of vancomycin and then again after to assess for change. The
      investigators will also assess the blood and stool of healthy people, and people with IBD
      (without PSC) as a control group.
    

Detailed description: 
      Primary Sclerosing Cholangitis (PSC) is a chronic inflammatory and fibrotic disease of the
      intra and extrahepatic ducts of unknown etiology that predominately occurs in people with
      Inflammatory Bowel Disease (IBD). One hypothesis is that altered microbiome (bacteria in the
      gut) in people with IBD are responsible for the inflammation in the liver seen in PSC. Bile
      acids (BAs) represent a unique mechanism of communication between the host and intestinal
      microbiome and the liver. Synthesized in the liver, bile acids are metabolized by intestinal
      bacteria hydroxylases to secondary BAs which then re-enter the portal circulation. Altered
      metabolism of BAs has been associated with gallstones and colorectal cancer and is
      hypothesized to play a role in the inflammatory response of certain disease such as IBD and
      PSC.

      IBD has been associated with impairment of bile acid (BA) metabolism. In addition BAs play a
      role in regulating bacterial growth of the intestine and thus have an effect on the integrity
      of the intestinal mucosa, which is an essential component of IBD. Perturbations in this
      system could increase bacterial translocation into the portal system due to loss of
      protective mucosal factors or bacterial overgrowth.

      The overall goal of this study is to assess the changes in BAs metabolism following
      administration of oral vancomycin. The investigators will also describe the relationship of
      the intestinal microbiome and BA metabolism in PSC/IBD.
    

Intervention name(s): Vancomycin
Intervention type(s): Drug
Intervention description(s): Oral vancomycin: 500mg suspended in prefilled syringes for oral use
Intervention MeSH terms: Vancomycin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Skin Irritation Study of GSK2894512 Cream
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK2894512 is a novel anti-inflammatory agent that is currently under development for the
      topical treatment of atopic dermatitis and chronic plaque psoriasis. This study will be a
      Phase I, single-center, randomized, partial-blinded (evaluator blinded) study which consists
      of two parts (Part 1 and 2). Part 1 of this study will assess skin irritation following a
      single application of GSK2894512 cream at 2 concentrations (e.g. 0.5% and 1%) and placebo by
      simple-patch test and photo-patch test under semi-occlusive conditions in 20 healthy Japanese
      volunteers. Part 2 of this study will assess skin irritation following repeat application at
      0.5% and 1% of GSK2894512 cream and placebo for 7 days under non-occlusive condition in 6
      healthy Japanese volunteers. The study will have Screening visit which will occur within 30
      days from the Day 1 visit of each part. Eligible subjects will be able to participate either
      of Part 1 or Part 2. Subjects will visit the site on Day -1, and hospitalized until the end
      of all assessments on Day 4 (Part 1) or Day 7 (Part 2). Subjects will re-visit the site on
      Day 8 (Part 1) or Day 15 (Part 2) for follow-up assessments. This study will be the first to
      evaluate the safety, tolerability and pharmacokinetics of GSK2894512 cream after single and
      repeat application in Japanese subjects. Results from this study will enable further clinical
      investigation in the Japanese population.
    


Intervention name(s): GSK2894512 Cream; Vehicle Cream; Empty Patch
Intervention type(s): Drug; Drug; Drug
Intervention description(s): GSK2894512 cream supplied will be white to off-white cream packaged in 28-gram laminate tubes of 2 concentrations: 0.5% and 1%, to be applied topically.; Vehicle Cream (placebo cream without active ingredient) supplied will be white to off-white cream packaged in 28-gram laminate tubes, to be applied topically.; Empty patches without any ingredients will be used as negative control.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Japanese; GSK2894512; skin safety
Oral Sedation With and Without Nitrous Oxide
Condition: Behavior, Child
Study type: Interventional
Phase: Phase 3

Summary: 
      Aims: The objective of the current study was to evaluate the effectiveness of oral
      midazolam-hydroxyzine with/without nitrous oxide. Design: This was a randomized split mouth,
      cross over and triple-blinded clinical study. Thirty uncooperative healthy children aged six
      to nine, whose needed dental treatments.
    

Detailed description: 
      The purpose of this study was to compare the efficacy of combining oral midazolam-hydroxyzine
      with/without N2O/O2 in sedating uncooperative schoolchildren undergoing dental treatment.
      Thirty uncooperative healthy children aged six to nine were randomly selected to receive
      either one tablet of oral midazolam 7.5 mg and one tablet of hydroxyzine 10 mg with 100% O2
      (regimen A), or one tablet of oral midazolam 7.5 mg and one tablet of hydroxyzine 10 mg with
      50% N2O/O2 (regimen B) in a crossover design. Behavior was assessed using the modified Houpt
      behavioral rating scale, by evaluating the videotapes of all patients at both the
      pretreatment phase (injection, rubber dam RD, operating high-speed handpiece with touching
      the tooth without drilling) and the treatment phase (drilling, restoration).
    

Intervention name(s): Midazolam-hydroxyzine with 100% O2; Midazolam-hydroxyzine with 50% N2O/O2
Intervention type(s): Drug; Drug
Intervention description(s): Patients received Oral Sedatives with 100% O2 ,Behavior was assessed using the modified Houpt behavioral rating scale, by evaluating the videotapes of all patients at both the pretreatment and treatment phases.; Patients received Oral Sedatives with 50% nitrous ,Behavior was assessed using the modified Houpt behavioral rating scale, by evaluating the videotapes of all patients at both the pretreatment and treatment phases.
Other intervention name(s): A; B
Intervention MeSH terms: Midazolam; Hydroxyzine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: blinded, randomized controlled trial, comparing two groups.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Midazolam; hydroxyzine; oxygen; behavior; child; tooth
Effectiveness and Safety of Minoxidil Foam Versus Placebo Foam for Androgenetic Alopecia
Condition: Androgenetic Alopecia
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 2

Summary: 
      The current study aims to show efficacy of twice daily application of 5% Minoxidil Topical
      Foam (MTF) formulation compared to placebo in the temple region of male patients with
      androgenetic alopecia after 24 weeks as well as to gain long-term data on the efficacy and
      safety of 5% MTF in male subjects with AGA in temple and vertex region, over a period of 2
      years. Objective and subjective efficacy measures will be compared to baseline. Moreover, all
      patients will get the equal treatment and measurements in the vertex region to enable
      comparison of the efficacy of 5% Minoxidil Topical Foam in the temples not only to baseline
      but also to vertex region. Additionally safety assessments will be performed throughout the
      whole study.
    


Intervention name(s): Minoxidil; vehicle of 5% Minoxidil topical foam
Intervention type(s): Drug; Drug
Intervention description(s): 1 g of 5% Minoxidil topical foam twice daily over 24 weeks in double-blinded phase and further 80 weeks in open-label-phase; 1 g of vehicle topical foam twice daily over 24 weeks in double-blinded phase and further 80 weeks in open-label-phase
Intervention MeSH terms: Minoxidil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Multiple Dose Study Investigating Pharmacokinetics and Pharmacodynamics of Subcutaneous NNC0363-0845 in Participants With Type 1 Diabetes Pharmacokinetics and Pharmacodynamics: How Insulin NNC0363-0845 is Transported Throughout the Body and How It Works
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to investigate the movement of insulin NNC0363-0845 throughout the
      body and how it works for the treatment of type 1 diabetes mellitus.

      The aim of the study is to improve clinical outcomes for patients with type 1 diabetes
      mellitus by better controlling the blood sugar levels.

      Participants will get insulin NNC0363-0845 as well as insulin detemir (Levemir®).
      NNC0363-0845 is a new insulin molecule designed to provide blood sugar-dependent insulin
      action, while insulin detemir is commonly used and prescribed by doctors.

      Participants will get subcutaneous (under your skin) injections of insulin NNC0363-0845
      (study medicine) up to 6 times daily for 3 days, and of insulin detemir up to 6 times daily
      for another 3 days. Which medication participants receive first and which second, insulin
      NNC0363-0845 or insulin detemir, is decided by chance.

      The study will last for about 6 weeks up to a maximum of 14 weeks. Participants will have 2
      in-house visits (where participants will stay at the site for 4 nights) and 5 outpatient
      visits with the study doctor. Participants will have frequent contact with the study doctor
      during the study.

      During the in-house visits, two intravenous catheters (a thin tube inserted into a vein) will
      be inserted for blood sampling and infusions.

      Interested parties may not participate in the study if the study doctor believes it will
      affect their health negatively.

      Women cannot take part if they are of childbearing potential.
    


Intervention name(s): NNC0363-0845; Insulin detemir
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive 0.5 nmol/kg NNC0363-0845 s.c. (subcutaneous - under the skin) every 4 hours up to 6 times daily (i.e. 3 nmol/kg/day) for 3 days The study will last for about 6 weeks up to a maximum of 14 weeks; Participants will receive 0.083 U/kg insulin detemir s.c. (subcutaneous - under the skin) every 4 hours up to 6 times daily (i.e. 0.5 U/kg/day) for 3 days The study will last for about 6 weeks up to a maximum of 14 weeks
Intervention MeSH terms: Insulin Detemir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety and Pharmacokinetics of Multiple Doses of BI 655064 in Healthy Chinese Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to investigate the safety and tolerability of multiple
      doses of BI 655064 following weekly subcutaneous injection for 4 weeks in healthy Chinese
      male volunteers.

      The secondary objective is the exploratory evaluation of the pharmacokinetics and
      pharmacodynamics of multiple doses of BI 655064 following weekly subcutaneous injection for 4
      weeks in healthy Chinese male volunteers.
    


Intervention name(s): BI 655064; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): subcutaneous injection; Placebo
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Misoprostol as a Treatment for Endometrial Polyps in Infertile Patients
Condition: Endometrial Polyps in Infertile Patients
MeSH terms: Uterine Neoplasms; Infertility; Polyps
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Endometrial polyps are one of the main causes of infertility in women. In this work we
      propose an alternative, effective, economical and safe treatment: the use of misoprostol
    

Detailed description: 
      The prevalence of uterine polyps has been estimated in the general population at 10-15%,
      while in infertile patients it ranges from 6-32%. Its etiology is considered as
      multifactorial. Polyps induce a local inflammatory response in the endometrial cavity,
      causing infertility. The treatment of choice considered "gold standard" is the excision by
      hysteroscopy, however, improvement has been shown in patients with conservative management
      due to the regression rate of 27%. There are no recommended drugs to provide a definitive
      treatment for uterine polyps. Misoprostol is a synthetic analogue derived from prostaglandin
      E1 that has stimulating effects on the smooth muscle fibers of the uterus, causing
      contractions of the myometrium, which cause endouterine evacuation. The present study shows a
      possible utility of misoprostol for the conservative treatment of uterine polyps.
    

Intervention name(s): Misoprostol
Intervention type(s): Drug
Intervention MeSH terms: Misoprostol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of TIP Urethroplasty With Spongioplasty-Dartosoraphy Reinforcement in Pediatric Hypospadias
Condition: Hypospadias; Complication,Postoperative
MeSH terms: Hypospadias; Postoperative Complications
Study type: Interventional

Summary: 
      The study aimed to evaluation of Tubularized incised palate urethroplasty with
      spongioplasty-dartosoraphy reinforcement (group A) through comparing of functional and
      cosmetic results of this technique with the conventional TIP urethroplasty (group B).
    


Intervention name(s): Tubularized Incised Plate (TIP) urethroplasty
Intervention type(s): Procedure
Intervention description(s): tubularization of urethral plate with or without spongioplasty
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Distal and midpenile hypospadias; TIPU; Spongioplasty-dartosoraphy; pediatric HOSE