bioihbjkbjnl/mcl2 huggingface dataset:
Long-term Outcomes and Life Satisfaction of Adults With Pediatric-Onset Spinal Cord Injuries
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Observational

Summary: 
      The purpose of this study is to assess life satisfaction and long-term outcomes (i.e.,
      medical and psychosocial) of adults who sustained spinal cord injuries (SCI) as children or
      adolescents.
    

Detailed description: 
      The ultimate goal of rehabilitation for children and adolescents with spinal cord injuries
      (SCIs) is to assure that they can grow up to have as productive and satisfying lives as their
      peers. Understanding factors associated with these outcomes of our patients after they have
      become adults may help to identify interventions and rehabilitation strategies that will
      optimize long-term outcomes. Long-term studies of adults with pediatric-onset SCI are needed
      to identify important outcomes, including survival, participation, health status and
      health-related quality of life, and life-satisfaction. Further, these outcomes need to be
      compared to population norms. Predictive models of important outcomes will be developed using
      independent factors, including demographic, impairment, functional limitation, participation,
      and environmental and personal factors. In addition, the impact of age at injury, upper
      extremity reconstruction or functional electrical stimulation implants, and the Mitrofanoff
      procedure on adult outcomes will be assessed. The stability of selected outcomes in
      comparison to normative and census data will be determined and factors associated with
      changes in these outcomes will be assessed.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The subjects for this study are adults who have received care in the SCI Programs of the
        Shriners Hospitals in Chicago, Philadelphia, or Northern California, who are 19 years of
        age and older and who were injured at age 18 years or younger.
Rural MOUD Telemedicine in Primary Care Phase 1
Condition: Opioid-use Disorder
MeSH terms: Opioid-Related Disorders; Substance-Related Disorders
Study type: Observational

Summary: 
      The feasibility study (Phase 1) will examine the implementation of telemedicine (TM) in six
      rural clinics in two states/regions with varying levels of OBOT capacity.
    

Detailed description: 
      The dramatic increases in opioid overdose deaths across the nation, particularly in rural
      areas, call for a rapid expansion of access to medication treatment for opioid use disorder
      (MOUD).There is a need to study effective ways to expand treatment access and improve
      retention on MOUD in rural areas highly impacted by OUD. Telemedicine (TM) for MOUD offers an
      alternative or supplementary approach to delivering MOUD that may be suitable for rural
      clinics and patients with OUD.

      The objectives of the feasibility study are to study ways of incorporating TM into primary
      care clinics and to evaluate the associated outcomes, based on EHRs from the clinics and the
      TM vendor (i.e., patient days on MOUD) and participant surveys (e.g., opioid use). Additional
      outcomes of the feasibility study are feasibility and acceptability assessed from the
      perspectives of providers and participants via focus groups. A patient registry will be
      established in each clinic to track patients with OUD diagnoses, and those in the registry
      will be provided the opportunity to consent for sharing identified EHRs and participating in
      the follow-up surveys.
    

Intervention name(s): Integration of telemedicine for MOUD in primary care
Intervention type(s): Other
Intervention description(s): Patients with opioid use disorder in rural primary care settings may be referred to receive telemedicine for medication treatment for opioid use disorder
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Primary care patients
      
Keywords: Medication treatment for opioid use disorder; Telemedicine; Rural areas
Implementation of Physical Exercise at the Workplace (IRMA09) - Laboratory Technicians
Condition: Musculoskeletal Disorders; Stress
MeSH terms: Musculoskeletal Diseases
Study type: Interventional

Summary: 
      Musculoskeletal disorders and stress of employees remain a major problem in many occupations.
      The aim of this study is to investigate the effect of an individually tailored
      bio-psycho-social intervention strategy versus "usual care" ergonomics and standard physical
      exercises (reference group) on musculoskeletal pain, work disability, and stress in lab
      technicians with a history of work-related musculoskeletal pain.
    


Intervention name(s): Biopsychosocial; Reference
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Peribulbar Block: Lidocaine-bupivacaine vs Lidocaine-bupivacaine-fentanyl
Condition: Anesthesia, Local
Study type: Interventional
Phase: Phase 3

Summary: 
      Ophthalmological procedures such as cataract extraction can be carried out with a peribulbar
      block (PBB). The advantages of this anesthetic technique include a lower incidence of
      coughing, unwanted movements and emesis during awakening, in addition to providing adequate
      postoperative analgesia. The researchers want to investigate whether the use of fentanyl
      citrate by peribulbar route, when administered with a local anesthetic, shortens the
      anesthetic latency, interfere with the degree of akinesia and if provides greater
      postoperative analgesia.
    

Detailed description: 
      Article Type. Clinical trial study
    

Intervention name(s): peribulbar block 1 lidocaine/bupivacaine; peribulbar block 2 lidocaine/bupivacaine/fentanyl
Intervention type(s): Drug; Drug
Intervention description(s): Peribulbar block: 100 mg of lidocaine 5% and 15 mg of bupivacaine 0.5% for a total volume of the anesthetic mixture of 5 ml.; Peribulbar block: 100 mg of lidocaine 5%, 15 mg of 0.5% bupivacaine and 50 mcg of fentanyl citrate for a total volume of the anesthetic mixture of 6 ml.
Other intervention name(s): lidocaine/bupivacaine; lidocaine/bupivacaine/fentanyl
Intervention MeSH terms: Lidocaine; Fentanyl; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Peribulbar block
Long-term Efficacy, Safety and Tolerability of Pramipexole in Patients With Idiopathic Moderate to Severe Restless Legs Syndrome (RLS)
Condition: Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of the current study will be the evaluation of long-term efficacy of a
      26-weeks treatment with pramipexole in patients with idiopathic moderate to severe Restless
      Legs Syndrome (RLS) in comparison to placebo.

      The key secondary objectives are to assess the effects on clinical global impressions -
      global improvement (CGI-I) (based on CGI-I responder rate) and on RLS (based on IRLS
      responder rate) for 26 weeks under pramipexole in comparison to placebo. Further secondary
      objectives are to investigate the incidence and severity of augmentation and rebound and to
      assess the effects on patient global impression (PGI) (based on PGI responder rate), on RLS
      symptoms (based on the RLS-6 scales), on associated mood disturbance (based on item 10 of the
      IRLS), on pain in limbs (based on a visual analogue scale (VAS)), on quality of life in RLS
      (based on Johns Hopkins RLS-QoL), on general quality of life Short Form 36 (SF-36) and on
      safety (based on adverse events (AE) profile) of pramipexole in comparison to placebo.
    


Intervention name(s): Pramipexole; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Pramipexole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Drug Interaction Study of LY3871801 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to determine the effect of LY3871801 when administered
      orally on the levels of methotrexate (part 1), drug cocktail (warfarin, dextromethorphan, and
      midazolam) and repaglinide (part 2) in the blood stream when administered orally in healthy
      participants. The information about any adverse effects experienced will be collected and the
      tolerability of LY3871801 will also be evaluated. The study may last up to approximately 25
      days for each participant.
    


Intervention name(s): LY3871801; Methotrexate; Warfarin; Dextromethorphan; Midazolam; Repaglinide
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Administered orally.; Administered orally.; Administered orally.; Administered orally.; Administered orally.; Administered orally.
Intervention MeSH terms: Repaglinide; Methotrexate; Midazolam; Dextromethorphan; Warfarin
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Looking for Personalized Nutrition for Obesity/Type 2 Diabetes Mellitus Prevention
Condition: Overweight and Obesity; Diabetes Mellitus, Type 2; Metabolic Syndrome; Genetic Predisposition; Diet Modification
MeSH terms: Diabetes Mellitus; Obesity; Overweight; Metabolic Syndrome; Diabetes Mellitus, Type 2; Genetic Predisposition to Disease
Study type: Interventional

Summary: 
      The objectives of this trial are to assess the effects of interactions between genetic
      factors and diet with various macronutrient intake on the metabolic disorders, obesity and
      type 2 diabetes risk, prevention, development and progress.
    

Detailed description: 
      This is a randomized, crossover study that includes 1 screening visit and four meal challenge
      test visits, separated by a 1-2-weeks washout period. The screening will include 2000 people,
      males and females, to evaluate the genotype frequencies in studied population, and to find
      carriers of the rare genetic single nucleotide polymorphisms (SNPs), who will fulfill all the
      other inclusion criteria. An oral glucose tolerance test (OGTT) will be completed at
      screening visit. Moreover, the fasting blood samples will be collected for genetic analysis,
      and measurements of blood glucose and lipid metabolism profile, high-sensitivity C-reactive
      protein (hs-CRP), hormones/peptides and other factors involved in energy balance regulation.
      Subjects will be asked to record their daily food intake for 3 days. Assessments of vital
      signs and body height and weight, waist and hip circumferences, body fat content and body fat
      distribution, review of concomitant medication/supplement use and inclusion and exclusion
      criteria, and evaluation of adverse effects will be performed throughout the study. To meal
      challenge test only men will be included, since the sex hormones may influence the study
      endpoints. Subjects will be encouraged to maintain their habitual diet during wash-out
      periods. During the each meal challenge test subjects will consume one of the study meals in
      random order. The blood will be collected at fasting state and 30, 60, 120, 180 and 240
      minutes after meal intake. The energy expenditure and substrate utilization will be measured
      by indirect calorimetry method at the fasting and postprandially.
    

Intervention name(s): Normo-carbohydrate meal intake; High-carbohydrate meal intake; High-fat meal intake; High-protein meal intake
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Subjects are going to receive the normo-carbohydrate meal.; Subjects are going to receive the high-carbohydrate meal.; Subjects are going to receive the high-fat meal.; Subjects are going to receive the high-protein meal.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
A Research Study of a New Medicine NNC0519-0130 in Japanese and Non-Japanese Men
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      NNC0519-0130 is a new medicine which may possibly help participants with type 2 diabetes.
      This study, will look into how safe the new medicine NNC0519-0130 is, and we will measure its
      concentrations in the blood and look at its effects. This study will last for a maximum of 22
      weeks and Japanese and Non-Japanese male participants will be included.
    


Intervention name(s): NNC0519-0130; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered subcutaneously.; Administered subcutaneously.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Famotidine on the Pharmacokinetics of Atazanavir When Coadministered to Participants With HIV Infection
Condition: HIV
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the effects of famotidine, given twice daily, on
      atazanavir administered with ritonavir and tenofovir in HIV-infected participants.
    

Detailed description: 
      This protocol was designed to compare the pharmacokinetic parameters of atazanavir
      administered as atazanavir/ritonavir, 400/100 mg once daily (QD), plus famotidine, 20 mg and
      40 mg twice daily, with the parameters found at the usual clinical dose of
      atazanavir/ritonavir, 300/100 mg QD, without famotidine in HIV-infected participants
      receiving tenofovir disoproxil fumarate and at least 1 other nucleoside reverse transcriptase
      inhibitor.
    

Intervention name(s): Atazanavir; Atazanavir; Ritonavir; Ritonavir; Tenofovir (TDF); Tenofovir (TDF); Nucleoside Reverse Transcriptase Inhibitor (NRTI); Nucleoside Reverse Transcriptase Inhibitor (NRTI); Famotidine (FAM); Famotidine (FAM)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Capsule, oral, 300 mg, once daily, 10 days; Capsule, oral, 400 mg, once daily, 7 days; Capsule, oral, 100 mg, once daily, 10 days; Capsule, oral, 100 mg, once daily, 7 days; Capsule, oral, 300 mg, once daily, 10 days; Capsule, oral, 300 mg, once daily, 7 days; Oral, 10 days; Oral, 7 days; Tablet, oral, 20 mg, twice daily, 7 days; Tablet, oral, 40 mg, twice daily, 7 days
Other intervention name(s): Reyataz; BMS-232632; Reyataz; BMS-232632
Intervention MeSH terms: Ritonavir; Atazanavir Sulfate; Tenofovir; Reverse Transcriptase Inhibitors; Famotidine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Safety, Tolerability & Pharmacokinetics Study of CNTX-6016 in Healthy Subjects and Subjects With PDN
Condition: Painful Diabetic Neuropathy
MeSH terms: Diabetic Neuropathies; Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1b study to evaluate the safety, tolerability and pharmacokinetics of multiple
      ascending doses of CNTX-6016 in healthy subjects and a single cohort to evaluate painful
      diabetic neuropathy.
    


Intervention name(s): Oral dose CNTX-6016 or oral dose Placebo
Intervention type(s): Drug
Intervention description(s): CNTX-6016 or Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Painful Diabetic Neuropathy
The Effect of a Curriculum-based Physical Activity Intervention on Physical Activity in Schoolchildren
Condition: Physical Activity
Study type: Interventional

Summary: 
      A non-randomised mixed methods controlled before-and-after study. The study evaluated the
      effects of a classroom-based physical activity intervention in primary school children on
      physical activity. Two schools were allocated to deliver the classroom-based intervention for
      eight weeks, and three schools continued with their usual school routine.
    

Detailed description: 
      The primary aim of this study was to test the feasibility and potential effect of a
      classroom-based, curriculum-embedded intervention - ExCiTE; Exercise Classes in the Teaching
      Environment- on total physical activity and moderate to vigorous physical activity. The
      secondary aim was to measure and describe health-related quality of life and physical fitness
      components, and to gain understanding of the experiences, views and attitudes towards the
      ExCiTE intervention among participating children and schoolteachers.
    

Intervention name(s): Classroom-based physical activity; Control Group
Intervention type(s): Other; Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Two school allocated to receive the intervention, three schools allocated to the control group
Masking: None (Open Label)
Primary purpose: Other
Keywords: school-based intervention; active classroom
Radiofrequency Ablation Using Octopus Electrodes for Small Hepatocellular Carcinoma With No-touch Technique
Condition: Hepatocellular Carcinoma; Radiofrequency Ablation
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional

Summary: 
      The aim of this study is to evaluate clinical outcome of RFA for small single nodular HCC
      using no touch technique with separable clustered electrode (Octopus) in a prospective
      multicenter manner Participating center: Seoul national university hospital, Asan medical
      center, Samsung medical center, Kunkuk university hospital, St. mary's Seoul hospital
    


Intervention name(s): RFA
Intervention type(s): Procedure
Intervention description(s): thermal ablation using radiofrequency for HCC
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
First-in-Human Exploratory Single Ascending Dose of GLPG0974
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this exploratory first-in-human study is to evaluate the amount of GLPG0974
      present in the blood (pharmacokinetics) after single oral doses of GLPG0974 given to healthy
      subjects.

      Furthermore, during the course of the study, safety and tolerability as well as the effects
      of GLPG0974 on mechanism of action-related parameters in the blood (pharmacodynamics) will be
      characterized compared to placebo.
    


Intervention name(s): GLPG0974; GLPG0974
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Systemic Bioactivity of Inhaled Nebulized RNS60
Condition: Systemic Bioactivity of Nebulized RNS60
Study type: Interventional
Phase: Phase 1

Summary: 
      The study aims to determine the effects of nebulized RNS60 on selected biomarkers in the
      circulation.
    

Detailed description: 
      The study is a double-blind, placebo controlled, parallel design study. Participants will be
      randomized to receive 2 daily doses of either nebulised RNS60 or placebo (n=28 per group) for
      22 days. On day 19 they will undergo an exercise protocol to induce muscle damage and blood
      samples will be taken on days 19, 20, 21 and 23 to determine the effects on CK and hsCRP. ROM
      and pain VAS assessments will also be completed.
    

Intervention name(s): RNS60; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): RNS60, 4 ml dose nebulized twice daily; Normal Saline, 4 ml dose nebulized twice daily
Intervention MeSH terms: RNS60
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of High-intensity Aerobic Training on Balance, Walking Capacity, and Quality of Life in Patients With Sub-acute Stroke.
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Stroke is one of the major cause of morbidity and mortality and the leading cause of
      disability in adults all around the world. Stroke survivors can suffer several neurological
      impairments and deficits which have an important impact on patient's quality of life and
      which increase the costs for health and social services. After stroke, impairments in ADLs
      and functional status, deterioration in health related quality of life can be seen.

      The purpose of this study is to Determine the effect of high intensity speed based treadmill
      training on Balance, Walking capacity and quality of life in sub-acute stroke.
    


Intervention name(s): Exercise Therapy; conventional therapy
Intervention type(s): Other; Other
Intervention description(s): High intensity speed based interval treadmill training; conventional physical therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cerebrovascular accident; Aerobic exercise; High intensity interval training
Prophylactic Antipyretic Treatment in Children Receiving Booster Dose of Pneumococcal Conjugate Vaccine GSK1024850A
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to assess if the rate of febrile reactions following the
      co-administration of a booster dose of pneumococcal conjugate vaccines with standard infant
      vaccines is lowered when paracetamol is given prophylactically and to assess the impact of
      pneumococcal conjugate vaccine on pneumococcal and H. influenzae nasopharyngeal carriage
      compared to control group receiving meningococcal conjugate vaccine (GSK134612).

      This protocol posting deals with objectives & outcome measures of the booster phase. The
      objectives & outcome measures of the primary phase are presented in a separate protocol
      posting (NCT number = NCT00370318).
    

Detailed description: 
      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Intervention name(s): Pneumococcal conjugate vaccine GSK1024850A.; Infanrix hexa.; Meningococcal vaccine GSK134612.; Paracetamol.
Intervention type(s): Biological; Biological; Biological; Drug
Intervention description(s): 1 intramuscular injection.; 1 intramuscular injection.; 1 intramuscular injection.; Body weight of < 7 kg: none; Body weight of ≥ 7 kg to < 9 kg : 3 suppositories of 125 mg to be administered at 8h intervals after vaccination. Body weight of ≥ 9 kg: 4 suppositories of 125 mg to be administered at 6h intervals after vaccination.
Other intervention name(s): DTPa-HBV-IPV/Hib; Mencevax™
Intervention MeSH terms: Acetaminophen; Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Streptococcus Pneumoniae Vaccines; Meningococcal disease; Carriage; Prophylactic antipyretic; Safety; Pneumococcal vaccine; Fever; Pneumococcal disease; Immunogenicity; Meningococcal vaccine; Booster vaccination