bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Aerobic Interval Training on Cardiovascular Function in Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The study objectives are:

        1. To compare cardiovascular function in type 2 diabetes patients vs. healthy controls.

        2. To compare the effect of 8 weeks of aerobic interval training versus continuous moderate
           exercise on cardiovascular function in adults with type 2 diabetes.

        3. To examine the mechanisms underlying the exercise-related changes in cardiovascular
           function.

      The investigators hypothesize that compared to continuous moderate intensity exercise
      training, interval training will be more effective in improving cardiovascular function in
      adults with type 2 diabetes.
    

Detailed description: 
      Cardiovascular function will be measured at baseline in adults with type 2 diabetes and in
      age-matched healthy controls. Research volunteers with type 2 diabetes who meet the inclusion
      criteria will be randomized to the aerobic interval training group, continuous moderate
      exercise group or non-exercise control group. At the end of the 8-week randomized control
      exercise intervention, baseline measures will be repeated.
    

Intervention name(s): High intensity aerobic interval training; Continuous moderate intensity exercise
Intervention type(s): Other; Other
Intervention description(s): Supervised aerobic interval training will be performed on bicycles 4 times per week for 8 weeks. Each training session will last 40 minutes and will consist of 10-minute warm up at 70% of maximal heart rate (HRmax), four 4-minute intervals at 90% of HRmax with 3-min active recovery at 70% of HRmax and 5-minute cool down at 70% of HRmax.; Supervised exercise training will be performed on bicycles 4 times per week for 8 weeks. Each training session will last 47 minutes and will consist of continuous moderate intensity cycling at 70% of HRmax.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Single and Multiple Ascending Dose Study for NKTR-118 and Cross-over Study to Investigate the Effect of Food for NKTR-118 in Japanese Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of NKTR-118 with healthy
      subjects.
    

Detailed description: 
      A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety,
      Tolerability and Pharmacokinetics of NKTR-118 following single and multiple ascending oral
      dose administration in healthy young and elderly Japanese subjects, and an Open Randomized,
      Crossover Study to Investigate the Effect of Food on the Pharmacokinetics after single oral
      doses of NKTR-118 in healthy male Japanese subjects
    

Intervention name(s): NKTR-118; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablet, Oral, Once daily; Tablet, Oral, Once daily
Intervention MeSH terms: Naloxegol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase I; Japan; SAD; MAD
Effect of Intravenous Amantadine on Gait Freezing in Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      A double-blinded randomized placebo-controlled trial of intravenous amantadine on gait
      freezing refractory to oral anti-parkinsonian medications in patients with Parkinson's
      disease.

        -  administration of IV amantadine or normal saline for 5 days, 2 times a day while keeping
           current oral anti-parkinsonian medications unchanged

        -  follow-up after administration of IV amantadine for 4 weeks

        -  allocation ratio of amantadine:normal saline is 2:1
    

Detailed description: 
      Intravenous amantadine is known to be effective for parkinsonian motor symptoms abruptly
      aggravated and for disabling motor symptoms from severe motor fluctuation and dyskinesia in
      patients with Parkinson's disease. The study investigators experienced several open label
      cases who were benefit from intravenous amantadine in their parkinsonian motor symptoms and
      freezing of gait as well. In addition, there is a pilot open label trial in parkinsonian
      patients with refractory freezing of gait which showed marked benefit in patients with
      Parkinson's disease, but not in patients with parkinson-plus syndromes.

      This study was aimed to evaluate the efficacy of intravenous amantadine in both
      levodopa-unresponsive freezing of gait and disabling off state freezing of gait in patients
      with Parkinson's disease.
    

Intervention name(s): amantadine sulfate; 0.9% sodium chloride
Intervention type(s): Drug; Drug
Intervention description(s): infusion of amantadine sulfate 100mg/500ml/bottle over 3 hours twice a day; infusion of normal saline 500ml/bottle over 3 hours twice a day
Other intervention name(s): PK-merz; normal saline
Intervention MeSH terms: Amantadine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Sensitivity of ECG on Detection of Three Different Intravascular Applied Test Doses of Bupivacaine and Epinephrine
Condition: Anaesthesia; Toxicity
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this prospective randomised study is to investigate electrocardiographic
      alterations after intravascular injection of three different test solutions of bupivacaine
      and epinephrine in anaesthetised children up to 16 years of age.
    


Intervention name(s): intravenous injection of test solution; intravenous injection of test solution; intravenous injection of test solution
Intervention type(s): Drug; Drug; Drug
Intervention description(s): test dose consists of 0.2 ml/kg body weight test solution of the assigned drug; test dose consists of 0.2 ml/kg body weight test solution of the assigned drug; test dose consists of 0.2 ml/kg body weight test solution of the assigned drug
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: local anaesthetics toxicity; heart arrhythmia; heart rate; heart conduction; regional anaesthesia; paediatric anaesthesia; cardio-vascular system; prevention
Peri Tonsillar Infiltration of Ketamine or Bupivacaine for Post Tonsillectomy Analgesia
Condition: Post Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Comparison between the analgesic effect of local infiltration of either Bupivacaine or
      ketamine in the peritonsillar area before the incision of tonsillectomy to achieve
      postoperative analgesia
    


Intervention name(s): Ketamine.; Bupivacaine
Intervention type(s): Drug; Drug
Intervention description(s): Peritonsillar infiltration of ketamine; peritonsillar infiltration of Bupivacaine
Intervention MeSH terms: Ketamine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Ketamine; Bupivacaine; tonsillectomy; analgesia
Pivotal Response Group Treatment for Parents of Young Children With Autism
Condition: Autistic Disorder
MeSH terms: Autistic Disorder
Study type: Interventional

Summary: 
      This is a research study examining the effectiveness of pivotal response treatment group
      (PRTG) in targeting language skills in young children with autism. Research has demonstrated
      that behavioral interventions, such as Pivotal Response Training (PRT), lead to improvements
      in the core symptoms of autism. The purpose of this study is to further examine the
      effectiveness of teaching pivotal response treatment to parents of children with autism in a
      group format. To determine the effectiveness of pivotal response training group (PRTG) it
      will be compared to another parent education group by conducting a randomized controlled
      12-week trial.
    

Detailed description: 
      This is a research study examining the effectiveness of pivotal response treatment group
      (PRTG) in targeting language skills in young children with autism. Research has demonstrated
      that behavioral interventions, such as Pivotal Response Training (PRT), lead to improvements
      in the core symptoms of autism. Researchers have begun to develop strategies to investigate
      the effectiveness of teaching parents how to implement PRT in a group format, as opposed to
      an individual format. Preliminary data has demonstrated that teaching PRT in a group format
      has shown to be effective in teaching parents and increasing children's communication skills.
      The purpose of this study is to further examine the effectiveness of teaching pivotal
      response treatment to parents of children with autism in a group format. To determine the
      effectiveness of pivotal response training group (PRTG) it will be compared to another parent
      education group by conducting a randomized controlled 12-week trial. PRTG will aim to teach
      parents pivotal response training strategies, whereas the parent psychoeducational group
      (PEG) will aim to teach parents information with regards to assessment and treatment for
      children with autism. By conducting this research it will improve researchers understanding
      of group treatment options for individuals with autism and allow us to help in the
      development of therapeutic approaches that can meet the increasing service demands for
      families.
    

Intervention name(s): Pivotal Response Training (PRT); Parent Education Group (PEG)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions.; 12 week program consisting of offering/discussion information for parents. No pivotal response training provided.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Autism PRT
Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) ( ULTIMATE 1 )
Condition: Relapsing Multiple Sclerosis (RMS)
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study determines the Annualized Relapse Rate (ARR) in participants with RMS after 96
      weeks (approximately 2 years) treatment with intravenous (IV) infusion of ublituximab/oral
      placebo compared to 14 mg oral teriflunomide/IV placebo.
    


Intervention name(s): Ublituximab; Teriflunomide; Oral Placebo; IV Placebo
Intervention type(s): Biological; Drug; Drug; Drug
Intervention description(s): Administered as an IV infusion.; Film-coated tablets administered orally.; Administered orally.; Administered as an IV infusion.
Other intervention name(s): TG-1101
Intervention MeSH terms: Teriflunomide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, multi-center, double-blinded, active-controlled study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Pilot Study to Evaluate the Pharmacokinetics of Omega-3 Between Rosuvastatin and Omega-3 Coadministration and HCP1007
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics of omega-3 between rosuvastatin
      and omega-3 coadministration and HCP1007 in healthy male volunteers.
    


Intervention name(s): HCP1007; Omarco and Crestor
Intervention type(s): Drug; Drug
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HCP1007; Rosuvastatin; Omega-3
Atelectasis by Lung Ultrasonography in Cesarean Sections
Condition: Atelectasis; Cesarean Section
MeSH terms: Pulmonary Atelectasis
Study type: Observational [Patient Registry]

Summary: 
      In this study aimed to demonstrate that atelectasis developing in the perioperative period of
      patients undergoing elective cesarean surgery with spinal or general anesthesia methods using
      lung ultrasound. After Preoperative lung ultrasounds of patients is done, the cesarean
      operation will be completed with spinal or general anesthesia. In the postoperative period,
      control lung ultrasounds will be performed and the ultrasound results will be compared in
      terms of atelectasis in both groups.
    


Intervention name(s): The Effect of General Anesthesia and Spinal Anesthesia on Postoperative Atelectasis by Lung Ultrasonography in Cesarean Sections
Intervention type(s): Procedure
Intervention description(s): Preoperative lung ultrasound will be performed on all patients and baseline values will be recorded. The sensory block level under T10 of the patients who underwent spinal anesthesia in the postoperative period lung ultrasonography will be done after regression. In the postoperative period, lung ultrasonography will be performed in patients undergoing spinal anesthesia when the sensory block level is below T10. In the general anesthesia group, when the neuromuscular block is completely reversed and the Aldrete score is> 9, lung ultrasonography will be performed. The degree of atelectasis will be determined according to the modified LUS score.
Intervention MeSH terms: Anesthetics
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Between 18-40 years old, 37-40 weeks pregnant, ASA II because of pregnancy.
A Single Ascending And Multiple Ascending Dose Study of RO5271983 in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This placebo-controlled, randomized, observer-blind, dose-ascending study will investigate
      the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses
      of RO5271983 in healthy volunteers. Healthy volunteers will be randomized to receive either a
      single oral dose of RO5271983 or placebo in the SAD part or multiple oral doses of RO5271983
      or placebo in the MAD part. The anticipated time on study treatment is approximately 14 weeks
      for the SAD part and up to 8 weeks for the MAD part.
    


Intervention name(s): Placebo - MAD; Placebo - SAD; RO5271983 - MAD; RO5271983 - SAD
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Once or twice daily doses of matching placebo to RO5271983 for 14 days; Single dose of matching placebo to RO5271983 for up to 3 periods; Once or twice daily doses of RO5271983 for 14 days; Single dose of RO5271983 at each period (for up to 3 periods)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Baclofen as Add-On to Standard Treatment of Alcohol- Dependent Patients
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a study of Baclofen as an add-on to standard treatment for alcohol-dependent
      patients.
    

Detailed description: 
      Double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo
      over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week
      and 52-week follow-up observations. The percentages of heavy drinking days and abstinent days
      were the primary outcome measures, and craving; distress and depression levels;
      self-efficacy; social support from family, friends and significant others; and health-related
      quality of life (HRQL) were secondary outcomes. Tolerability was also examined.
    

Intervention name(s): Baclofen; Control group
Intervention type(s): Drug; Other
Intervention description(s): Baclofen 50mg per day for 12 weeks and psychosocial intervention; psychosocial intervention and placebo for 12 weeks
Other intervention name(s): Placebo group
Intervention MeSH terms: Baclofen
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Baclofen; Alcohol; Baclofen as add-on to standard treatment of alcohol
Study Evaluating Safety, Tolerability, and PK of DVS SR in Healthy Japanese Women
Condition: Vasomotor Symptoms
Study type: Interventional
Phase: Phase 1

Summary: 
      Safety, tolerability, and pharmacokinetics (PK) of desvenlafaxine succinate sustained release
      (DVS SR) in healthy Japanese female subjects.
    


Intervention name(s): desvenlafaxine succinate sustained release (DVS SR)
Intervention type(s): Drug
Intervention MeSH terms: Desvenlafaxine Succinate
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Treatment
The Effect of Liraglutide on Endothelial Function in Subjects With Type 2 Diabetes Mellitus
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted in the United States of America (USA). The purpose of the trial is to
      assess the effect of liraglutide on forearm blood flow in subjects with type 2 diabetes who
      are on diet and lifestyle changes or treated with metformin alone.
    


Intervention name(s): liraglutide; placebo; glimepiride
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Stepwise dose increase, s.c. (under the skin) injection, once daily; Liraglutide placebo, stepwise dose increase, s.c. (under the skin) injection, once daily; Tablets, 1 - 4 mg daily
Intervention MeSH terms: Liraglutide; Glimepiride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparison Study of a New Combination of 2 Marketed Medications (Esomeprazole and Naprosyn) Versus Naprosyn Alone
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether the absorption of naproxen from the PN 400
      combination (Naprosyn and Esomeprazole) tablets is similar to that from the naproxen tablets
      (Naprosyn®), which are currently sold in Australia.
    


Intervention name(s): PN400; Naprosyn
Intervention type(s): Drug; Drug
Intervention description(s): 500mg Naproxen and 20mg esomeprazole; 500mg Naproxen
Other intervention name(s): VIMOVO™
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: GI Pain; healthy participants; Safety; bioavailability
Alternate-Day Buprenorphine. Phase V - 6
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate buprenorphine blockade challenge.
    


Intervention name(s): Buprenorphine
Intervention type(s): Drug
Intervention MeSH terms: Buprenorphine
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Enhancing Connections: Helping the Mother With Breast Cancer Support Her Child
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a 6-state randomized controlled trial (RCT) that uses a behavioral intervention to
      enhance parenting skills for school age children when a mother is recently diagnosed with
      early stage breast cancer. Efficacy analyses will include measures of the child's and
      mother's psychosocial adjustment, including enhanced parenting quality and skills related to
      the cancer.
    

Detailed description: 
      This is a Phase 3 randomized clinical trial of recently diagnosed mothers with local or
      regional breast cancer and their school age child. After baseline measures are taken, mothers
      are randomized into either intervention and control group. Intervention participants are
      given 5, 1-hour at home educational counseling sessions by a specially trained nurse. Control
      participants are mailed an educational booklet whose content focuses on supportive parenting
      behaviors that are part of the face to face sessions given to the experimental group.

      The theoretical framework for the study derives from Bandura's Social Cognitive Theory, a
      contextual model of parenting, and stress and coping theory. Efficacy is evaluated through
      standardized valid and reliable questionnaires of psychosocial functioning in the mother
      (affect, mood, self-efficacy) and psychosocial functioning in the child (cognitive-emotional
      functioning, including behavioral problems, anxiety, depressed mood, and cancer-related
      concerns). Primary study hypotheses will be evaluated comparing pre-posttest measures of the
      intervention compared to controls at post-test and 1-year follow up.
    

Intervention name(s): Educational counseling intervention
Intervention type(s): Behavioral
Intervention description(s): This intervention involves 5 face to face educational counseling sessions with a specially trained patient educator; sessions are fully manualized and complemented by handouts given to the diagnosed parent.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: breast cancer,; child functioning,; parenting,; self-efficacy,; psychoeducational intervention; counseling