bioihbjkbjnl/mcl2 huggingface dataset:
Promoting Physical Activity for Persons With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The purpose of this study was to determine whether a group wellness intervention or
      individualized physical rehabilitation was more effective in improving health and physical
      activity in persons with multiple sclerosis.
    

Detailed description: 
      Evidence from this study shows that both interventions were effective in improving health and
      physical activity in persons with multiple sclerosis. The results also show that participants
      may benefit more physically from individualized physical rehabilitation and more mentally
      from group wellness interventions. Interventions that combine individualized therapeutic
      exercise with group health education might be most effective for persons with multiple
      sclerosis.
    

Intervention name(s): Group wellness intervention; Individualized physical rehabilitation
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Health Services Research
Keywords: Chronic Disabling Condition; Comparative Evaluation; Physical Activity; Physical Therapy; Rehabilitation
Efficacy and Safety of Diamyd® in Children and Adolescents With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, placebo-controlled phase II study to investigate if a prime and boost
      of 20ug Diamyd® (rhGAD65 formulated in Alhydrogel®), administered subcutaneously four weeks
      apart, is safe and can preserve beta cell function in children and adolescents with type 1
      diabetes with a diabetes duration less than 18 months at intervention.
    


Intervention name(s): rhGAD65 formulated in Alhydrogel® (Diamyd®)
Intervention type(s): Drug
Intervention MeSH terms: Aluminum Hydroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Type 1 diabetes; GAD65; Autoimmunity; C-peptide; Children
Study of Tipranavir and Ritonavir on the Pharmacokinetic Characteristics of Methadone Administered in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to characterise the effects of tipranavir 500 mg and
      ritonavir 200 mg (TPV/r; given twice daily) at steady-state on the pharmacokinetics of
      methadone administered as a single dose in healthy adult volunteers
    


Intervention name(s): Tipranavir; Ritonavir; Methadone
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Ritonavir; Tipranavir; Methadone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Exenatide and Insulin Glargine in Subjects With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This Phase 3, open-label, multicenter study is designed to compare the effects of exenatide
      and insulin glargine (Lantus® injection) on beta-cell function in patients with type 2
      diabetes mellitus using metformin.
    


Intervention name(s): exenatide; Insulin glargine; Metformin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): subcutaneous injection, titrated up to a maximum of 20mcg three times a day in order to meet defined blood glucose targets; subcutaneous injection, once a day, titrated as necessary in order to meet defined blood glucose targets; Patients usual dosage
Other intervention name(s): Byetta; Lantus
Intervention MeSH terms: Metformin; Insulin Glargine; Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes; exenatide; exendin-4; Amylin; Lilly
Rituximab Plus Chemotherapy in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Condition: Head and Neck Squamous Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Study type: Interventional
Phase: Phase 1

Summary: 
      Head and neck squamous cell carcinoma (HNSCC) is an important disease with the incidence of
      6th all over the world. In Taiwan it is the fifth of male cancer mortality. Most of the
      patients were middle age and the impact for economy and society was incredible. For recurrent
      or metastatic HNSCC, the average life span was around 4-6 months. Most patients just can
      receive chemotherapy. However the chemotherapy can't have any survival benefit. Recently a
      study showed the Cetuximab plus chemotherapy with cisplatin and 5-fluorouracil had survival
      benefit in the recurrent or metastatic HNSCC. However in Taiwan, the cetuximab can't be given
      by health insurance for the patients of the situation.

      A lot of investigations recently showed the B lymphocytes got involvements in the squamous
      cell carcinoma carcinogenesis and tumor progression. In addition the B cell will influence
      the tumor associated macrophages and myeloid derived suppressor cells. Those immune cells
      could decrease the affect of chemotherapy and radiotherapy. Thus the B cell depletion has the
      possibility to develop a new treatment policy. Therefore investigators create a pilot
      clinical trial using Rituximab plus chemotherapy with cisplatin and gemcitabine for recurrent
      or metastatic HNSCC.
    


Intervention name(s): Rituximab; Cisplatin; Gemcitabine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 375mg/m2 on Day-14 and Day-7; 70mg/m2 on Day1; 1000mg/m2 on Day8
Other intervention name(s): Mab thera; Platinex; Gemzar
Intervention MeSH terms: Rituximab; Gemcitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: head and neck squamous cell carcinoma; Rituximab; recurrent or metastatic
Pharmacokinetics (PK) of Antistaphylococcal Antibiotics in Infants (NICHD-2012-02-Staph Trio)
Condition: Systemic Infection
MeSH terms: Sepsis
Study type: Interventional
Phase: Phase 1

Summary: 
      Multiple center, open-label, PK study
    

Detailed description: 
      Pharmacokinetics of rifampin, ticarcillin-clavulanate, and clindamycin antibiotics in
      hospitalized infants with suspected systemic infection or receiving one of the study drugs
      per local standard of care. Number of participants are 16-32 evaluable per each study drug of
      rifampin, ticarcillin-clavulanate, and clindamycin antibiotics.
    

Intervention name(s): Antibiotic
Intervention type(s): Drug
Intervention description(s): Ticarcillin-clavulanate/Timentin is an antibiotic used to treat a wide variety of bacterial infections. Rifampin/Rifadin/Rimatane is an antibiotic and first line antituberculotic. Clindamycin/Cleocin is an antibiotic used to treat a wide variety of bacterial infections and serious bacterial infections.
Other intervention name(s): Ticarcillin-clavulanate generic; Brand Timentin; Rifampin generic; Brand Rifadin, Rimatane; Clindamycin generic; Brand Cleocin
Intervention MeSH terms: Anti-Bacterial Agents; Rifampin; Clindamycin; Clavulanic Acid; Ticarcillin; Ticarcillin-clavulanic acid
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Staphylococcal
Effect of an Alternative RUTF on Intestinal Permeability in Children With Severe Acute Malnutrition
Condition: Malnutrition, Child
MeSH terms: Malnutrition; Severe Acute Malnutrition; Child Nutrition Disorders
Study type: Interventional

Summary: 
      Ready-to-use therapeutic food (RUTF) is the standard of care for the treatment of SAM. UNICEF
      requires that there be no oil separation in these products necessitating the use of
      emulsifiers. The effect of emulsifiers on gut health and integrity in children receiving an
      exclusive diet of RUTF is unknown. The PIs have recently completed a randomized,
      triple-blind, controlled, clinical equivalency trial in Sierra Leone comparing the
      alternative oat RUTF (oat-RUTF) to standard RUTF on recovery rates in children with SAM. This
      study demonstrated higher rates of recovery among children receiving the oat-RUTF. The
      investigators hypothesize that this benefit may be due to the lack of emulsifier in the
      oat-RUTF resulting in improved intestinal health.This research project is a double-blind,
      randomized, controlled clinical effectiveness trial comparing a novel RUTF containing oats
      and no emulsifier and standard RUTF on recovery from severe acute malnutrition (SAM) and
      effects on intestinal health. The trial will be conducted in up to 40 PHUs in Western Rural
      and Pujehun Districts where supplementary feeding programs (SFP) are not currently available.
    


Intervention name(s): S-RUTF; oat RUTF
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Children will receive approximately 175 kcal/kg/d of standard ready-to-use therapeutic food which provides a full daily doses of vitamins and micronutrients. Caregivers will instruct caregivers to feed the supplement only to the enrolled child.; Children will receive approximately 175 kcal/kg/d of oat ready-to-use therapeutic food which provides a full daily doses of vitamins and micronutrients. Caregivers will instruct caregivers to feed the supplement only to the enrolled child.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Efficacy and Safety of Alogliptin Used in Combination With α-glucosidase Inhibitor in Participants With Type 2 Diabetes in Japan
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study was to evaluate the efficacy and safety of alogliptin, once daily
      (QD) combined with an α-glucosidase inhibitor taken three times daily (TID) in type 2
      diabetic patients with uncontrolled blood glucose.
    

Detailed description: 
      Both insulin hyposecretion and insulin-resistance are considered to be involved in the
      development of type 2 diabetes mellitus.

      Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients
      with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV
      (DPP-IV) enzyme. DPP-IV is thought to be primarily responsible for the degradation of 2
      peptide hormones released in response to nutrient ingestion. It is expected that inhibition
      of DPP-IV will improve glycemic control in patients with type 2 diabetes.

      In Japan, α-glucosidase inhibitors are widely used as a first-line treatment for type 2
      diabetes mellitus. Because alogliptin has a different mechanism of action compared to
      α-glucosidase inhibitors, the study evaluated the efficacy and safety of alogliptin combined
      with an α-glucosidase inhibitor in type 2 diabetic patients with uncontrolled blood glucose
      while taking a α-glucosidase inhibitor and receiving diet and/or exercise therapies.

      To evaluate the long-term safety and efficacy of the concomitant use of alogliptin and an
      α-glucosidase inhibitor, subjects who participated in the present study could enter a
      long-term extension study SYR-322/OCT-003 (NCT01263509) that was planned separately.
    

Intervention name(s): Alogliptin and voglibose; Alogliptin and voglibose; Voglibose
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.; Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.; Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Other intervention name(s): SYR-322; BASEN®; Voglibose; SYR-322; BASEN®; Voglibose; BASEN®
Intervention MeSH terms: Inositol; Alogliptin; Voglibose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes Mellitus - Type 2; Diabetes Mellitus; Drug Therapy
The Impact of Distraction on Adenoma Detection Rate
Condition: Adenoma
MeSH terms: Adenoma
Study type: Interventional

Summary: 
      The investigators will review video-recordings of three randomized, controlled trials
      (NCT01535326, 01699399, and 01894191) comparing air insufflation, water immersion and water
      exchange during colonoscopy. These studies were all conducted at Buddhist Dalin Tzu Chi
      Hospital.
    

Detailed description: 
      The investigators will review video-recordings of three randomized controlled trials
      (NCT01535326, 01699399, and 01894191) comparing air insufflation, water immersion and water
      exchange. These studies were conducted at Buddhist Dalin Tzu Chi Hospital. Permission will be
      obtained from the local Institutional Review Board (IRB) to review, analyze and report
      de-identified findings.

      Two experienced endoscopists (YHH and CWT) performed all the recorded colonoscopies.
      Recordings will be selected for review if they are complete examinations; include clear
      identification of the appendiceal orifice and/or the ileocecal valve, indicating arrival at
      the cecum; available in the appropriate format for video editing; and contain no patient or
      endoscopist identifiers. Patients with incomplete recordings and a history of bowel resection
      will be excluded from analysis. The included video recordings will be edited to remove the
      insertion phase to blind the study reviewer to the insertion techniques. One blinded reviewer
      uninvolved in the performance of the colonoscopies will be in charge of evaluating the
      selected videos, using the criteria described by Yung et al
    

Intervention name(s): Air insufflation; water immersion; Water exchange
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Air insufflation during colonoscopy including insertion phase; Water will infused during insertion phase and removed during withdrawal phase of colonoscopy.; Water will infused and removed during insertion phase of colonoscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: colonoscopy; water exchange; adenoma detection rate; distraction
Study Evaluating the Tolerability of Bifeprunox in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Safety and tolerability study in healthy volunteers
    


Intervention name(s): bifeprunox
Intervention type(s): Drug
Intervention description(s): oral tablet once daily
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
A Phase I Study of the Safety and Immunogenicity of rgp120/HIV-1IIIB Vaccine in Healthy Adult Subjects (NOTE: Study Extended ONLY for Subjects Who Have Previously Received rgp120/HIV-1IIIB or rgp120/HIV-1MN on VEU 006 or VEU 006 Rollover Study)
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      AMENDED 11/17/93: To determine whether the pattern of response to MN rgp120 vaccine is
      altered by pre-exposure to IIIB rgp120.

      ORIGINAL DESIGN: To evaluate the safety (clinical and immunologic) of rgp120/HIV-1IIIB
      vaccine (gp120 vaccine) immunization in healthy HIV-1 seronegative adult subjects. To compare
      the immune response to 100 mcg gp120 vaccine versus 300 mcg gp120 vaccine. To determine
      whether gp120 vaccine immunization causes a significant immune response as defined by
      specific parameters (e.g., induction of neutralizing antibodies to the IIIB isolate of HIV-1,
      gp120 antigen-specific lymphocytic proliferation).

      Recent evidence suggests that gp120 is the HIV-1 protein with the greatest potential as a
      vaccine against HIV-1 infection. The gp120 envelope protein may be produced by recombinant
      DNA technology, and studies have shown that the vaccine is capable of eliciting neutralizing
      antibody activity in both rodents and nonhuman primate species.
    

Detailed description: 
      Recent evidence suggests that gp120 is the HIV-1 protein with the greatest potential as a
      vaccine against HIV-1 infection. The gp120 envelope protein may be produced by recombinant
      DNA technology, and studies have shown that the vaccine is capable of eliciting neutralizing
      antibody activity in both rodents and nonhuman primate species.

      AMENDED 11/17/93: Selected subjects from VEU 006 or VEU 006 Rollover study will receive two
      injections of MN rgp120 vaccine, administered 28 days apart beginning 10-16 months after
      their last injection. Eight additional clinic visits will be required. Subjects are followed
      for at least 6 months.

      ORIGINAL DESIGN: Twenty-eight subjects will be randomized to receive 100 or 300 mcg
      rgp120/HIV-1IIIB vaccine (gp120 vaccine) or matching placebo. For each dose level, 10
      subjects will receive vaccine and four subjects will receive matching placebo. Injections are
      given intramuscularly at 0, 4, and 32 weeks. Each subject receiving treatment at the lower
      dose level must be monitored for unacceptable toxicity for at least 2 weeks following the
      initial immunization before his or her second dose is administered and before treatment at
      the higher dose level begins. Subjects are followed for at least 12 months.
    

Intervention name(s): rgp120/HIV-1IIIB; rgp120/HIV-1MN
Intervention type(s): Biological; Biological
Masking: Double
Primary purpose: Prevention
Keywords: Vaccines, Synthetic; Viral Vaccines; HIV-1; HIV Envelope Protein gp120; AIDS Vaccines; HIV Seronegativity; HIV Preventive Vaccine
Development of Horse-Riding Program Model for Children With Cerebral Palsy
Condition: Cerebral Palsy; Motor Activity
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      The purpose of this study is to develop healing riding algorithm applicable in rural riding
      centers and to apply this to children with cerebral palsy.
    

Detailed description: 
      Horseback riding activities in Korea's riding centers have mostly centered on physical
      rehabilitation for children with special needs, including those with cerebral palsy, mental
      disabilities, and autism, with the program conducted by certified equine-assisted therapy
      instructors. However, there is no definite way to assess the ability of children for
      horseback riding and no standard riding program. Therefore, developing a assessment and
      program algorithm for healing horseback riding is expected to contribute to providing more
      activities for children with special needs and also for general people.

      Children older than 4 years old or adolescent with cerebral palsy who voluntarily want to
      enroll this study would be enrolled.

      Participants have 2 times of 30-minute horse riding program for 8 weeks, total 16 times of
      riding program in a local horse riding center.

      Sample size assessment: Calculating for 20% of drop out, 16 patients were calculated to apply
      the assessment and applicable program.

      Drop out: missing more than 2 lessons of horse-riding

      Plan for missing data: not included

      Statistical analysis plan: paired t-test for the outcome measures
    

Intervention name(s): Horseback riding therapy
Intervention type(s): Behavioral
Intervention description(s): Apply 30 minutes/session, twice a week for 8 weeks of horseback riding therapy (provided with 1 horse rider, 2 side walkers)
Other intervention name(s): hippotherapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: cerebral palsy; horseback riding
Phase Ia Study of ChAd63/MVA PvDBP
Condition: Malaria; Plasmodium Vivax
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label phase Ia study, to assess the safety of two novel malaria vaccines,
      ChAd63 PvDBP, with or without MVA PvDBP. Heterologous prime-boost with ChAd63-MVA is, to our
      knowledge, one of the most potent T cell-inducing subunit vaccine regimens which can
      importantly also induce antibodies. Previous clinical trials using this regimen expressing
      ME-TRAP, AMA1 & MSP1, have shown that administering ChAd63 as a prime followed 8 weeks later
      by MVA as a boost is a very immunogenic schedule (32-34). For this reason, and to provide
      comparability with previous ChAd63-MVA trials, we propose to use a similar administration
      schedule.
    


Intervention name(s): ChAd63 PvDBP 5 x 10^9; ChAd63 PvDBP 5 x 10^10; MVA PvDBP 1 x 10^8; MVA PvDBP 2 x 10^8
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 1 dose of ChAd63 PvDBP 5 x 10^9 vp intramuscularly; 1 dose of ChAd63 PvDBP 5 x 10^10 vp intramuscularly; 1 dose MVA PvDBP 1 x 108 pfu 8 weeks later intramuscularly; 1 dose MVA PvDBP 2 x 108 pfu 8 weeks later intramuscularly
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: PvDBP; Malaria; Plasmodium vivax
Resilience in Girls Victims of Sexual Abuse
Condition: Child Sexual Abuse
Study type: Interventional

Summary: 
      İn this study, it was aimed to examine the effectiveness of the psychological resilience
      program for adolescent girls after sexual abuse.This study is a randomized controlled trial.
    

Detailed description: 
      Sexual abuse, which is a universal problem, affects the functioning of many institutions of
      society and can lead to lifelong physical, mental and social problems and health problems for
      children.The process of coping and adapting to stressful challenges such as sexual abuse is
      explained by psychological resilience.

      Social support provided by parents, peers and professionals from the onset of sexual abuse
      contributes positively to children's lives and facilitates adaptation.Group therapies to be
      applied to abuse victims can increase perceived social support by reducing negative effects
      such as shame and stigmatization.
    

Intervention name(s): Psychological Resilience Program
Intervention type(s): Behavioral
Intervention description(s): The psychological resilience program was applied to the children in the intervention group twice a week for a total of 5 weeks. Each session consisted of 90 minutes of structured practice. The application is carried out using narrative therapy, cognitive behavioral therapy, psychodrama and analogy techniques, self-assessment and didactic teaching techniques. In addition, participants were engaged in self-regulation exercises and positive imagery activities. Each session includes practices on empathy, stress management, resilience, realistic and unrealistic thinking, optimism and pessimism, autonomy and humor related to resilience.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The sample consisted of girls who agreed to participate in the study and one of their family members (mother, father, aunt, etc.).
Masking: Double (Participant, Investigator)
Primary purpose: Prevention