bioihbjkbjnl/mcl2 huggingface dataset:
Goal-Directed Therapist-Guided Play-Based Intervention in Children With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      Abstract Objective: This study planned to examine the effect of Goal-Directed
      Therapist-Guided Play-Based Intervention (GD-TG-PBI) on occupational performance,
      occupational satisfaction and functional performance in children with diplegic cerebral palsy
      (DCP).

      Materials and Methods: This study was designed as a randomized controlled trial. 34 children
      with DCP (14 boys; 20 girls) who received routine therapy included to the study. All children
      were classified according to the Gross Motor Function Classification System (GMFCS) and the
      Manual Abilities Classification System (MACS). Participants were randomly divided into two
      groups: the GD-TG-PBI group (number =17; mean age: 7.70±2.25 years) and the control group
      (number =17; mean age: 7.41±2.06 years). Both groups received routine therapy twice a week
      for 45 minutes per session during 8 weeks; while the GD-TG-PBI group received GD-TG-PBI
      additional to routine therapy twice a week for 45 minutes per session during 8 weeks.
      Occupational performance and satisfaction were determined with the Canadian Occupational
      Performance Measure (COPM), and functional performance was evaluated with the Pediatric
      Evaluation of Disability Inventory (PEDI). The COPM and PEDI were performed before and after
      the intervention for both groups. Dİfferences between COPM and PEDI values before and after
      the intervention calculated, additionally the effect size of each parameter calculated.
    


Intervention name(s): Goal-Directed Therapist-Guided Play-Based Intervention (GD-TG-PBI)
Intervention type(s): Other
Intervention description(s): The GD-TG-PBI used play to improve performance in targeted functional activities. The program was planned by a physiotherapist with 25 years' experience and an occupational therapist with six years' experience in play. The sessions were based on motor-learning principles supporting cortical plasticity. Individual-specific goals were transformed into play activities that increase occupational participation with regard to the child's abilities, needs, and learning potential. A top-down approach based on direct gamification was adapted without dividing it into components, instead of a component-based, bottom-up approach. Thus, a structured play program was created and an individual-specific intervention was applied in line with the occupational goals and detailed motor evaluations. Positive, active experiences facilitated the adaptation of the learned skills to daily life.
Other intervention name(s): Goal-Directed Therapist-Guided Play-Based Intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: play, child, intervention
Study of Losartan in the Treatment of NAFLD in Children
Condition: NAFLD
MeSH terms: Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Non-alcoholic fatty liver disease (NAFLD) is the most common liver disease among children and
      is closely associated with obesity and the metabolic syndrome. NAFLD increases risk of
      mortality and natural history studies of adults show that NAFLD is an independent risk factor
      for cardiovascular disease. Pediatric NAFLD is particularly concerning from a public health
      standpoint, as it represents an early and possibly more aggressive form of the disease.
      Currently there is no effective treatment for pediatric NAFLD.

      Losartan is an orally-administered angiotensin II receptor antagonist which is currently on
      the market to treat high blood pressure. The renin-angiotensin-aldosterone (RAA) system has
      been shown to be important in many disease states including renal disease, cardiovascular
      disease, and NAFLD. Angiotensin antagonists are a class of medications that has been proposed
      as a novel treatment of NAFLD in part because they would treat both the factors increasing
      cardiovascular (CVD) risks as well as potentially improve steatosis, fibrosis and hepatic
      inflammation.

      This study is a randomized, double-blinded, placebo-controlled pilot study to evaluate
      whether 8 weeks of Losartan will decrease inflammatory markers among children ages 12-19 with
      a current diagnosis of NAFLD. Efficacy will be assessed by improvement in alanine
      aminotransferase (ALT) from baseline. Secondary endpoints will include aspartate
      aminotransferase (AST), cytokeratin 18 levels, and fasting triglyceride levels among others.
      Safety will be assessed by the recording of adverse events, clinical laboratory parameters,
      vital signs and physical examinations.
    


Intervention name(s): Losartan
Intervention type(s): Drug
Intervention description(s): Oral tablet to be taken once daily at 0.4mg/kg/day (max 25mg) for one week and then increased to 0.8mg/kg/day (max 50mg) for 7 additional weeks.
Other intervention name(s): Cozaar; Losartan Potassium Tablets; Serial Number: 74193404
Intervention MeSH terms: Losartan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: NAFLD; Non-alcoholic Fatty Liver Disease; Obesity; Pediatrics; Children; Losartan; Cozaar
Comparison of Mechanical Bowel Preparation Versus Enema for Candidates to Colorectal Resection for Adenocarcinoma
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate mechanical bowel preparation (MBP) with polyethylene
      glycol plus bowel enema versus bowel enema alone in patients candidates to colorectal
      resection for malignancy.
    

Detailed description: 
      Surgical site infections (SSI) in colorectal surgery (anastomotic leakage, wound infection,
      intraabdominal abscess) are associated with increased mortality, postoperative hospital stay
      and costs. From a recent metanalysis and randomized clinical trial there is the emerging
      evidence that mechanical bowel preparation (MBP) before elective colorectal surgery is not
      associated with reduction of SIS, although it causes high discomfort for patients. On the
      same way other more recent studies show that MBP may cause an higher incidence of SIS, and
      that MBP may alter the bowel mucosa morphology. Other Authors report an increased incidence
      of anastomotic leakage requiring surgery for patients undergoing a single preoperative
      phosphate enema whereas but an higher cardiovascular mortality for patients undergoing MBP.
      Two recent studies do not clarify the usefulness of MBP for reducing SIS after colorectal
      surgery and one stage anastomosis. For these reasons a more precise understanding of the
      relationship between MBP and SIS could increase patients satisfaction and decrease
      unnecessary procedures and costs. At this point MBP represent the clinical standard for
      patients undergoing elective colorectal surgery at the European Institute of Oncology.
    

Intervention name(s): mechanical bowel preparation; enema
Intervention type(s): Other; Other
Intervention description(s): fiberless diet starting 2 days before surgery. Drugs containing iron and coal plant will be stopped. Free breakfast the day before surgery. Lunch: meat broth and white meat. From 16 p. m. to 20 p. m. assumption of Polyethylene Glycol Macrogol 70 mg per 1 liter of water 4 times (1L each hour). A bowel enema (2L, glycerin 5%) will be administered at 6 a. m. the day of surgery.; fiberless diet starting 2 days before surgery. Drugs containing iron and coal plant will be stopped. Free breakfast the day before surgery. Lunch: meat broth and white meat. Dinner: meat broth and fasting starting from midnight. A bowel single enema (2L, glycerin 5%) will be administered at 6 a. m. the day of surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mechanical Bowel Preparation (MBP); enema
Repair of Infective Wound Associated With Nerve Defect in the Finger Using A Bipedicled Nerve Flap
Condition: Infection Wound; Disruption of Nerve Repair
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      A combination of soft tissue and digital nerve defects in the finger results in sensory loss
      of the finger pulp. Reconstruction of these combined injuries is difficult. When the
      neurocutaneous defect is associated with wound infection, reconstructive alternatives are
      more limited. From July 2008 to May 2010, a retrospective study was conducted with 9
      consecutive postinfection patients who had the neurocutaneous defect of the finger following
      trauma. The purpose of this retrospective study is to report repair of the complicated
      infected wound in the finger using the bipedicled nerve flap and to evaluate the efficacy of
      this technique.
    

Detailed description: 
      sensation of the flaps is assessed using static two-point discrimination (2PD) and
      Semmes-Weinstein monofilament (SWM) testing at final follow-up. The cold intolerance of the
      injured finger is measured using the self-administered Cold Intolerance Severity Score
      questionnaire that was rated into mild, moderate, severe, and extreme (0-25, 26-50, 51-75 and
      76-100). Patients report their satisfaction with functional recovery of the injured finger
      according to the Michigan Hand Outcomes Questionnaire that was based on a 5-point response
      scale.
    

Intervention name(s): Nerve flap
Intervention type(s): Device
Intervention description(s): Based on the Teoh et al.'s technique, we combined the nerve graft into the bipedicled heterodigital arterialized island flap and used this composite flap tissue for reconstructing complicated infected wound in the finger.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: defect;; dorsal branch of the proper digital nerve;; proper digital nerve;; finger sensory reconstruction.
SI-613 Study for Knee Osteoarthritis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of the study is to evaluate the efficacy and safety of intra-articular
      injections of SI-613 compared with placebo for knee OA.
    


Intervention name(s): SI-613; Placebo
Intervention type(s): Combination Product; Combination Product
Intervention description(s): SI-613 will be repeated intra-articularly administered.; Placebo will be repeated intra-articularly administered.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Knee; Osteoarthritis; Intra-articular injection
Comparing Autologous Peripheral Blood Stem Cell to Bone Marrow Transplantation for Recurrent Non-Hodgkin's Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the difference in relapse rates and long term event
      free survival in patients with intermediate grade or immunoblastic non-Hodgkin's lymphoma
      (NHL) whose marrow is not obviously involved with NHL who are randomized to receive either an
      autologous bone marrow (ABMT) or peripheral stem cell transplant (PSCT). All patients with
      intermediate grade NHL with histologic negative bone marrow who would otherwise meet all
      eligibility criteria for high-dose therapy and ABMT are eligible for this study. Patients who
      are eligible will be randomized to either PSCT or ABMT at the time of enrollment into our
      transplant program.
    

Detailed description: 
      These patients would be enrolled in a high-dose protocol using carmustine, etoposide,
      cytarabine, and cytoxan (BEAC) with autologous hematopoietic rescue. The patients will be
      stratified according to good and poor prognosis category and relapsed vs. first partial
      response categories. The patients will have bone marrow or peripheral stem cells collected
      according to standard protocols. A standardized hematopoietic growth factor will be used for
      mobilization and post-transplant. The patients' PSC or bone marrow (BM) product will be
      assayed via invitro-culture techniques for occult tumor, and by molecular biologic assays.
      The patients' outcome for transplantation will be evaluated with response to transplantation,
      relapse rates and event free survival being the measured end points.
    

Intervention name(s): PBSCT; Bone Marrow Transplant
Intervention type(s): Procedure; Procedure
Intervention description(s): Peripheral Blood Stem Cell Transplant; Bone Marrow Transplant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NHL; Non Hodgkins Lymphoma; BMT; Bone Marrow Transplant; PBSCT; Peripheral Blood Stem Cell Transplant; PSCT
Evaluation of Demonstrations to End Childhood Hunger - VA
Condition: Food Insecurity Among Children
Study type: Interventional

Summary: 
      The 2010 Child Nutrition Reauthorization provided funding to test innovative strategies to
      end childhood hunger and food insecurity. Demonstration projects were funded in Chickasaw
      Nation, Kentucky, Navajo Nation, Nevada, and Virginia. This study focuses on Virginia. A
      selection of schools were randomly assigned to either a treatment or control group. Children
      in treatment schools received: (1) three meals during the school day and food packages for
      weekends and school breaks; (2) $60 monthly Electronic Benefit Transfer (EBT) benefits during
      summer months if they were eligible for FRP meals; and (3) nutrition education for their
      parents. The control group operated under "business as usual."
    

Detailed description: 
      Objective: To reduce hunger 365 days a year in households with schoolchildren by transforming
      schools into food hubs and providing nutrition education to parents.

      Target Population: Elementary (n=30), middle (n=6), and high schools (n=2) in rural and urban
      VA. All schools had low academic performance and at least 50 percent of children eligible for
      free and reduced-price (FRP) meals.

      Intervention: Schools were randomly assigned to either a treatment or control group. Children
      in treatment schools received: (1) three meals during the school day and food packages for
      weekends and school breaks; (2) $60 monthly Electronic Benefit Transfer (EBT) benefits during
      summer months if they were eligible for FRP meals; and (3) nutrition education for their
      parents. The control group operated under "business as usual." Note that the $60 monthly
      benefit was not included in the evaluation of the demonstration.
    

Intervention name(s): VA 365 Demonstration Benefits
Intervention type(s): Behavioral
Intervention description(s): Reducing hunger 365 days a year in households with school children by transforming schools into food hubs ( free breakfast, lunch, supper, and food backpacks for the weekend) and providing nutrition education to parents.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Food Security; National School Lunch Program (NSLP); School Breakfast Program (SBP); Child and Adult Care Food Program (CACFP); Food Backpacks
Efficacy Study of OPC-34712 in Adults With Acute Schizophrenia
Condition: Acute Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the efficacy, safety, and tolerability of fixed doses
      of OPC-34712 versus placebo for the treatment of adult subjects with an acute relapse of
      schizophrenia.
    

Detailed description: 
      Schizophrenia is a severely debilitating mental illness that affects approximately 1% of the
      world population. Hallucinations and delusions are the most striking characteristic positive
      symptoms of schizophrenia; however, more subtle negative symptoms (eg, social withdrawal and
      lack of emotion, energy, and motivation) may also be present. The first antipsychotics
      developed for the treatment of schizophrenia were effective against positive symptoms, but
      showed little efficacy for negative symptoms and were also associated with a high incidence
      of side effects. Second generation antipsychotics, represent a significant advancement in the
      treatment of psychotic disorders because they are effective and at the same time exhibit
      fewer side effects than first generation antipsychotics. Although generally safer than first
      generation antipsychotics, the second-generation antipsychotics are not devoid of undesirable
      side effects such as Hyperprolactinemia and weight gain. In addition, the safety of these
      drugs vary considerably.
    

Intervention name(s): OPC-34712; OPC-34712; OPC-34712; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Higher dose tablet, once daily, for six weeks,; Middle dose tablet, once daily, for six weeks; Lower dose tablet, once daily, for six weeks; Placebo, once daily, for six weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of Atvogen in Healthy Volunteers and HIV-Infected Patients Who Have No Symptoms of Infection
Condition: HIV Infections
MeSH terms: Infections
Study type: Interventional

Summary: 
      To evaluate the degree and sequence of immunologic enhancement and the cellular resistance to
      certain infections after a single dose of atvogen (ampligen). In addition, the relationship
      between activation of immune cells and biochemical markers of that activation will be
      studied.

      Treatment of patients with HIV infection must address both the primary viral infection and
      the subsequent immune deficiency, which is the primary cause of mortality in AIDS. In vitro
      studies of ampligen have shown it will inhibit HIV infection. Ampligen may also minimize the
      toxicity of many drugs used in the treatment of AIDS and induce an antiviral state in the
      brain that may be useful in treating neurologic symptoms of HIV infection. The time course
      and degree of immunologic response to ampligen remain unknown although they are essential for
      proper use of the drug in the treatment of HIV infection and perhaps other clinical problems.
    

Detailed description: 
      Treatment of patients with HIV infection must address both the primary viral infection and
      the subsequent immune deficiency, which is the primary cause of mortality in AIDS. In vitro
      studies of ampligen have shown it will inhibit HIV infection. Ampligen may also minimize the
      toxicity of many drugs used in the treatment of AIDS and induce an antiviral state in the
      brain that may be useful in treating neurologic symptoms of HIV infection. The time course
      and degree of immunologic response to ampligen remain unknown although they are essential for
      proper use of the drug in the treatment of HIV infection and perhaps other clinical problems.

      Ten healthy volunteers and 10 HIV-infected patients are randomized between ampligen or
      placebo group. Five volunteers in each group receive a single dose of ampligen on day 1 and a
      single dose of placebo on day 8. The other 5 volunteers receive the drug and placebo on day 8
      and 1, respectively. Seven days of observation and testing follow each administration of drug
      or placebo and also allow the body to eliminate the drug.
    

Intervention name(s): Ampligen
Intervention type(s): Drug
Intervention MeSH terms: poly(I).poly(c12,U)
Masking: Double
Primary purpose: Treatment
Keywords: Macrophage Activation; Lymphocyte Transformation; Immunologic Surveillance; ampligen; Antiviral Agents
GLP-1 Mediating DPP-4 Inhibition in Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      To determine the extent to which the effects of treatment with LAF237 100 mg QD on glucagon
      secretion are mediated by Glucagon-like-peptide 1 (GLP-1) in type 2 diabetic patients and
      healthy subjects.
    

Detailed description: 
      Design:

      This two center study employs a double blind, placebo controlled, cross-over study in
      patients with type 2 diabetes (T2D) and healthy volunteers with comparable age, gender and
      BMI distribution. Subjects (40 patients and 40 healthy volunteers, referred to as subjects in
      remaining part of the document) will be randomized to 100 mg LAF 237 QD or placebo for two
      10-day treatment periods in a cross-over design. Thirty two (32) efficacy evaluable patients
      are required to complete the study.

      Each subjects will participate in an approximate 14-day screening period, a 2-week wash-out
      period from metformin, a 1-day baseline period and a 10-day treatment period followed by a
      2-4 week wash-out period and a second treatment period. An end of study evaluation will be
      conducted following the completion of the second treatment period or in the event of early
      withdrawal or termination of the patient.

      At screening, subjects meeting inclusion/exclusion criteria will begin a weight maintenance
      diet containing 50% carbohydrates, 30% protein and 20% fat. Patients will receive guidance on
      dietary maintenance at screening and will stay on this diet from screening to the end of
      study evaluation. Following the screening visit, enrolled patients will start a 2 week drug
      wash-out period where oral hypoglycemic medication will be discontinued.

      During the drug wash-out period, all patients will monitor their glucose levels two times a
      day (prior to breakfast and dinner) using a glucometer. Additionally, at one week intervals,
      patients will perform a seven point blood glucose test, where glucose measurements will be
      made prior to and two hours after each meal, and prior to bed. Weekly telephone calls will be
      made to each patient, where the results of these glucose tests will be recorded. Patients
      will be discontinued from the study during the wash-out period if fasting glucose levels
      exceed 200 mg/dl on any two consecutive measurements.
    

Intervention name(s): Exendin [9-39]; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Exendin [9-39] at 350 and 500 pmol/kg/min for infusion as challenge agent; Placebo infusion as challenge agent
Other intervention name(s): (GLP-1 receptor antagonist)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Gastric Inhibitory Polypeptide (GIP); Glucagon-Like Peptide 1 (GLP-1); DPP-4 inhibition; Exendin [9-39]; Gastric emptying; Glucagon; Incretin; Insulin Secretion; Normal glucose-tolerant