bioihbjkbjnl/mcl2 huggingface dataset:
Telehealth Coaching for Families of Children With Autism
Condition: Autism Spectrum Disorders
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the efficacy of a 12 week telehealth intervention
      for families of children with autism spectrum disorders under the age of 6 years on child
      participation and parent efficacy.
    

Detailed description: 
      Autism spectrum disorders (ASD) are increasingly being diagnosed in children, creating a
      pressing need for effective and cost-efficient models of early intervention (EI) services.
      Many EI systems are struggling to meet the needs of the increasing number of families of
      children with ASD. In rural areas, there is a shortage of EI therapists, and the distances to
      reach families results in an inefficient use of professional time and research shows that
      rural families of children with ASD receive fewer EI services, which has detrimental effects
      on children's developmental trajectories. If occupational therapy interventions for young
      children with ASD utilize innovative methods of service delivery in rural areas,
      investigators can increase the number of families that receive services thereby positively
      influencing child and family outcomes. Therefore, investigators propose to test the
      acceptability, cost-effectiveness, and efficacy of a 12 week telehealth intervention for
      families of young children with ASD.
    

Intervention name(s): Occupational Performance Coaching (OPC)
Intervention type(s): Behavioral
Intervention description(s): OPC focuses on increasing positive child-caregiver interactions and child learning opportunities in everyday routines and contexts, which positions families for improved trajectories over time. OPC capitalizes on families' strengths, while supporting caregivers in using their own resources and ideas to advance child function. Caregivers identify goals, while therapists ask reflective questions and make reflective comments, affording caregivers an opportunity to gain a deeper understanding of their own current knowledge and the impact of their strategies on their children's adaptive behavior. Thus, families generate their own solutions and are ultimately responsible for carrying out the intervention and evaluating its effectiveness.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: telehealth
Levels of the Stat4 Alpha and Stat4 Beta Isoforms in PBMCs From Patients With Crohn's Disease and Ulcerative Colitis
Condition: Inflammatory Bowel Disease; Crohn's Disease; Ulcerative Colitis
MeSH terms: Crohn Disease; Colitis; Colitis, Ulcerative; Inflammatory Bowel Diseases; Ulcer
Study type: Interventional

Summary: 
      The goal in these studies will be to assess the relative levels of the Stat4 alpha and Stat4
      beta isoforms in PBMCs from patients with Crohn's Disease, ulcerative colitis, celiac disease
      or from control patients. We hypothesize that the beta to alpha ratio will be higher in
      patients with active disease and that there will be a correlation between the ratio and the
      severity of disease.
    


Intervention name(s): measurement of inflammatory markers
Intervention type(s): Other
Intervention description(s): measuring inflammatory markers and comparing to controls.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: IBD; CD; UC; Crohn's Disease; Ulcerative Colitis; Pediatric; inflammatory markers
A Study of Capecitabine (Xeloda) and Peginterferon Alfa-2a (Pegasys) in Treatment-Naive Participants With Advanced Liver Cancer
Condition: Carcinoma, Hepatocellular
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the efficacy and safety of capecitabine (Xeloda) in combination with
      peginterferon alfa-2a (Pegasys) in participants with advanced liver cancer who have had no
      prior treatment. The anticipated time on study treatment is until disease progression, and
      the target sample size is 43 individuals.
    


Intervention name(s): Capecitabine; Peginterferon alfa-2a
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive oral capecitabine, 1000 mg/m^2 twice daily on Days 1 to 14 of each 21-day cycle, for at least 6 cycles (18 weeks). Treatment may continue until disease progression, intolerable toxicity, or consent withdrawal.; Participants will receive SC peginterferon alfa-2a, 180 mcg every week during each 21-day cycle, for at least 6 cycles (18 weeks). Treatment may continue until disease progression, intolerable toxicity, or consent withdrawal.
Other intervention name(s): Xeloda; Pegasys
Intervention MeSH terms: Peginterferon alfa-2a; Capecitabine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bike Skills Training for Children With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      An assessor blinded multi-centre randomized controlled trial will be conducted in which 60
      participants will be randomized to either a novel task-specific approach to training bike
      skills or a parent-led home program comparison group. Baseline assessment will take place
      within 6 weeks prior to starting the intervention (T0) and outcomes will be assessed within a
      week following (T1); and at 12 - 14 weeks following (T2) the week long intervention. The
      primary outcome is attainment of individualised two-wheel bike specific goals at T1. All
      statistical analysis will be conducted on an intention-to-treat basis. Logistic regression
      will be used to assess the effect of providing the novel intervention compared to the
      parent-led home program on bike-specific goal attainment.
    


Intervention name(s): Novel task-specific bike skills training program; Parent-led home-based bike skills training program
Intervention type(s): Other; Other
Intervention description(s): Participants randomised to the intervention group will participate in a novel task-specific bike skills training program. The intervention involves seven key components: it is group-based, intensive (2 hours per day for 3 days plus a home program for the remaining days of the one week period), task-specific, goal-directed, and therapist led, with parent involvement and conducted in an ecological setting. Each program will be run by a physiotherapist and allied health assistant during the school holidays.; The comparison group will involve a parent-led home-based bike skills training program. Parents of children randomized to the comparison group will receive written information and telephone support from a physiotherapist on training bike skills. They will be encouraged to work with their child towards their bike skills goals for at least 30-45 minutes per day over a one week period during the school holidays in home and community environments.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: motor learning; participation
Prevention of Human Papillomavirus (HPV) in 20 to 45 Year Old Chinese Women (V501-041)
Condition: HPV Infections
MeSH terms: Papillomavirus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      A study to test the safety and effectiveness of Quadrivalent HPV (types 6, 11, 16, 18) L1 VLP
      vaccine against combined incidence of HPV 6/11/16/18-related persistent infection and vaccine
      type-specific genital disease among Chinese females between the ages of 20 and 45.
    

Detailed description: 
      The Base Study V501-041 duration was 30 months. The study was extended to further evaluate
      the efficacy of Quadrivalent HPV (Type 6, 11, 16, 18) L1 VLP (qHPV) vaccine against Cervical
      Intraepithelial Neoplasia Grade 2 (CIN 2), CIN 3, Adenocarcinoma In Situ (AIS), and/or
      cervical cancer. The efficacy was followed through the Month 78 visit, and the close-out
      visit was conducted at approximately Month 90 with only safety data collected
    

Intervention name(s): Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine; Comparator: placebo (unspecified)
Intervention type(s): Biological; Biological
Intervention description(s): Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine injection at Day 1, Month 2, and Month 6.; Aluminum-containing Vaccine placebo injection at Day 1, Month 2, and Month 6.
Other intervention name(s): Gardasil ™; V501
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: HPV 6/11/16/18 Infection
HP184 in Chronic Spinal Cord Injury Subjects
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether HP184 is effective in the treatment of
      chronic spinal cord injury (CSCI).
    


Intervention name(s): HP184
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Efficacy and Safety of NYX-2925 in Subjects With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
Condition: Diabetic Peripheral Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Neuralgia; Diabetic Neuropathies
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the efficacy of multiple dose levels of NYX-2925 versus placebo in treating the
      neuropathic pain associated with Diabetic Peripheral Neuropathy.
    

Detailed description: 
      This is a randomized, double-blind, parallel-group, placebo-controlled, multiple-dose study
      to assess the efficacy and safety of NYX-2925 in subjects with neuropathic pain associated
      with diabetic peripheral neuropathy.

      The study will be a 6 to 9-week study, including a 1 to 4-week (dependent on duration of
      washout period) Screening Period, followed by a 4-week double-blind, randomized,
      placebo-controlled Treatment Period, and a 1-week Follow Up Period. Subjects eligible for the
      study will randomize to receive either NYX-2925 or placebo for 4 weeks.
    

Intervention name(s): NYX-2925; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): NYX-2925 is a novel small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).; Matching Placebo capsules.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomized to receive placebo or NYX-2925.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: Type 2 Diabetes; Neuropathic Pain; Peripheral Nervous System
Comparison of Synera Patch Versus LMX-4 Cream Versus Placebo Patch for Pain Reduction During Venipuncture in Children
Condition: Pain; Venipuncture; Anesthetics, Local
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the effect of Synera patch versus LMX-4 cream and
      placebo on the level of pain, observed distress, difficulty of venipuncture and skin side
      effects in children undergoing intravenous blood draw in the emergency setting or the
      phlebotomy lab.
    

Detailed description: 
      This study will compare the effectiveness of a patch applied for 30 minutes (Synera-lidocaine
      70 mg/tetracaine 70 mg) with the effectiveness of a cream (LMX-4- 4% liposomal lidocaine) and
      a placebo patch applied for the same length of time in reducing pain due to needle sticks in
      children. One hundred fifty children and adolescents 5-17 years old admitted to emergency
      department or presenting to the phlebotomy lab. will be randomly placed in each group.
      Children will rate their level of pain using the Faces Pain Scale-Revised (FPS-R) before the
      medication is applied, after the medication is removed and after the needle stick. Parents
      and research observer will fill out the Observed Behavioral Distress (OBD) score. The
      phlebotomist will rate how difficult it was to perform the needle sticks. Any skin reaction
      seen by the investigator after the cream or patch is removed will be noted and compared among
      the three groups.

      Subjects will be monitored from the time of enrollment to 5 minutes post phlebotomy.The Time
      Frame for which data will be presented is one (1) year.
    

Intervention name(s): Synera Patch; LMX 4 Cream; Placebo Patch
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Synera Patch (lidocaine 70 mg/ tetracaine 70 mg) will be applied for 30 minutes to the venipuncture site; LMX 4 (4% liposomal lidocaine) cream (2g) will be applied under Tegaderm for 30 minutes to the venipuncture site.; A placebo patch with the same properties as the Synera patch but without lidocaine/tetracaine will be administered for 30 minutes to the venipuncture site.
Other intervention name(s): Synera; LMX-4; Placebo
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain; Children; Local anesthetics
Drug Eluting Stent (DES) in Primary Angioplasty
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Stent implantation is the best treatment in patients with acute myocardial infarction (STEMI)
      referred for primary angioplasty (pPCI). However the occurrence of in stent restenosis is
      responsible for the need of repeat intervention. Both Sirolimus-eluting stents (SES) and
      Paclitaxel-eluting stents (PES) have been proven to virtually abolish in-stent restenosis in
      elective patients in simple e more complex lesions. Both SES and PES have raised concerns
      regarding occurrence of late stent thrombosis, especially in complex lesion subsets or in
      high risk patients. The PaclitAxel or Sirolimus-Eluting Stent vs Bare Metal Stent in primary
      angioplasty (PASEO) trial was a prospective, single-center, randomized trial evaluating the
      benefits of SES or PES as compared to BMS implantation in patients undergoing primary
      angioplasty for acute STEMI. From 1 October 2003 we randomized with 1:1:1 ratio, 270 patients
      with STEMI and treated with pPCI, to implantation of a bare metal stent (BMS n=90), PES
      (n=90) or SES (n=90).
    


Intervention name(s): Drug Eluting Stent (DES)
Intervention type(s): Device
Intervention description(s): Open-label randomization was performed after initial angiography by the treating physician when eligibility criteria were met. All patients received in the CCU 70U/Kg i.v. bolus of UFH plus 1000U/h infusion (to maintain an ACT of at least 200 seconds), aspirin intravenously (500 mg) and clopidogrel (300 mg loading dose). All patients received upstream Gp IIb-IIIa inhibitors administration as a routine adjunctive therapy before primary PCI. Postinterventional antiplatelet therapy for all patients included in the three study group, consisted of aspirin (100 mg) indefinitely and clopidogrel (75 mg for six months). Stenting procedures were performed according to standard techniques. The number and length of stents, and the type of BMS to be implanted, were left to the operator's discretion. The operator was allowed to implant DES to cover the entire length of the lesion with coverage of the entire stented segment and of 5 mm proximal and distal segments.
Other intervention name(s): Primary Angioplasty; Cypher; Taxus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute Myocardial Infarction; Drug Eluting Stent; Primary PCI
Sleep Apnea and Gestational Diabetes
Condition: Gestational Diabetes; Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Diabetes, Gestational; Diabetes Mellitus
Study type: Interventional

Summary: 
      The investigators hypothesize that pregnant women with gestational diabetes will have a high
      incidence of sleep apnea, and that the treatment of sleep apnea will lead to improved glucose
      control in these women.
    


Intervention name(s): Continuous positive airway pressure (S9, ResMed)
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effects of Mechnikov Probiotics on Symptom and Surgical Outcome
Condition: Sigmoid Colon Cancer
MeSH terms: Colonic Neoplasms; Sigmoid Neoplasms
Study type: Interventional

Summary: 
      The purpose of this clinical trial study was to evaluate the prevalence of colon cancer among
      the symptom (s) of anterior resection syndrome that may occur after surgery in patients for
      efficacy and safety in Metchnik probiotic ingestion.
    

Detailed description: 
      The purpose of the clinical trial is to evaluate the efficacy and safety of the syndrome that
      may occur after colon cancer surgery, To evaluate the efficacy and safety of the improvement
      effect of the defecatory activity on the improvement of the Medienkov probiotics biotics on
      the patients who have the deficit function and planned to surgery.
    

Intervention name(s): Mechnicov probiotics; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Using placebo comparator with experimental one, it will be compared between two group for comparison of placebo comparator with experimental one.
The patients enrolled into expeimental group will take one pack of 'Mechnicov probiotics' twice a day for 4 weeks from 1 week before surgery.
(1 week before surgery and 3 weeks after surgery)
The patients in placebo and experimental group should take a part in this clinical trial under the condition of 'anterior resection of colon cancer'; Using placebo comparator with experimental one, it will be compared between two group for comparison of placebo comparator with experimental one.
The patients enrolled into expeimental group will take one pack of 'Mechnicov probiotics' twice a day for 4 weeks from 1 week before surgery.
(1 week before surgery and 3 weeks after surgery)
The patients in placebo and experimental group should take a part in this clinical trial under the condition of 'anterior resection of colon cancer'
Other intervention name(s): Anterior resection; Anterior resection
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study has been designed for randomized, double Blinded, placebo clinical trial.
Masking: Single (Care Provider)
Primary purpose: Treatment
Dipeptidyl Peptidase-4 Inhibitor (Sitagliptin) Therapy in the Inpatients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus; Hospitalization; Hyperglycemia
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hyperglycemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The study is a multicenter, prospective, open-label, randomized pilot study to investigate
      the safety and efficacy of sitagliptin (Januvia) for the inpatient management of type 2
      diabetes (T2D) in general medicine and surgery patients.
    

Detailed description: 
      High blood glucose levels in hospitalized patients with diabetes are associated with
      increased risk of medical complications and death. Improved glucose control with insulin
      injections may improve clinical outcome and prevent some of the hospital complications.
      Glargine (Lantus®) insulin injection is the most common treatment of diabetes in the
      hospital. Sitagliptin (Januvia®)is effective in lowering blood glucose, but has not been
      tested in the hospital. It is not known if sitagliptin is as effective in controlling blood
      sugars in the hospital. This study will compare sitagliptin by mouth, insulin (glargine)
      injection, and the combination of sitagliptin and lantus insulin in controlling blood sugar
      in hospitalized patients with diabetes.

      In this pilot study, patients with known history of diabetes treated with diet and/or oral
      anti-diabetics or with low total daily dose insulin therapy (<0.4 unit/kg/day) will be
      randomized to receive sitagliptin once daily (group 1), sitagliptin plus basal (glargine)
      insulin once daily (group 2), or basal bolus regimen with glargine once daily and lispro
      insulin before meals (group 3). If needed, patients in the 3 treatment groups will receive
      correction doses of rapid-acting lispro (Humalog®) insulin in the presence of hyperglycemia
      (BG > 140 mg/dl) per sliding scale. The overall hypothesis is that treatment with sitagliptin
      once daily alone or in combination with basal insulin in patients with type 2 diabetes will
      result in a similar improvement in glycemic control and in a lower frequency of hypoglycemic
      events than treatment with basal bolus insulin regimen with glargine once daily and lispro
      insulin before meals.

      A total of 90 subjects with type 2 diabetes will be recruited in this study. Patients will be
      recruited at Grady Memorial Hospital and Emory University Hospital.
    

Intervention name(s): Sitagliptin; glargine; lispro
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Sitagliptin 50-100mg po once daily; glargine once daily; lispro before meals
Other intervention name(s): Januvia; Lantus (glargine); Humalog (lispro)
Intervention MeSH terms: Insulin Glargine; Sitagliptin Phosphate; Insulin Lispro
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes; non critical care setting; hyperglycemia; treatment; oral antidiabetic agents; subcutaneous insulin