bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Aerobic Training on Exercise Capacity in Patients With Cirrhosis
Condition: Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Interventional

Summary: 
      Cirrhosis is associated with a reduction in muscle mass and exercise capacity. This has an
      impact or morbidity and mortality. Regular aerobic exercise training is a proven effective
      therapy to improve exercise capacity in healthy and clinical populations. the effect of this
      training has not yet been evaluated in cirrhosis. The safety of this intervention also
      requires further study. Using a randomized controlled design, the investigators aim to
      conduct a pilot study evaluating the safety and efficacy of eight weeks of aerobic exercise
      training on aerobic capacity.
    


Intervention name(s): Aerobic exercise; Usual Care
Intervention type(s): Behavioral; Other
Intervention description(s): Aerobic exercise for 8 weeks (3 times per week, 30-60 minutes each session)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Selumetinib Paediatric NF1 Japan Study
Condition: Neurofibromatosis Type 1
MeSH terms: Neurofibromatoses; Neurofibromatosis 1; Neurofibroma
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I open label study designed to evaluate the safety, tolerability, PK and
      efficacy of selumetinib in Japanese paediatric patients with neurofibromatosis type 1 and
      inoperable and symptomatic plexiform neurofibroma.
    


Intervention name(s): Selumetinib
Intervention type(s): Drug
Intervention description(s): Selumetinib 25 mg/m2 BID
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Carbohydrates and Gut Hormones After Gastric Bypass Surgery
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      To investigate the secretion of gut hormones, in particular glucagon-like peptide 1 (GLP-1),
      after ingestion of glucose and fructose as separate monosaccharides or combined in the
      disaccharides sucrose and isomaltulose and the effect of acarbose in gastric bypass operated
      subjects and BMI-matched controls.
    

Detailed description: 
      Disaccharides such as sucrose or isomaltulose (also called palatinose) require digestion into
      monosaccharides (both are digested to glucose and fructose) by enzymes located in the brush
      border of the small intestine to be absorbed. The study will investigate the influence of
      carbohydrate digestion on gut hormone secretion.
    

Intervention name(s): Glucose + Fructose; Sucrose; Isomaltulose; Sucrose + Acarbose
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Ingestion of the separate monosaccharides glucose (25 g) and fructose (25 g) dissolved in 200 mL of water. The load provides 0.1385 mol glucose and 0.1385 mol fructose.; Ingestion of the disaccharide sucrose (47.5 g) dissolved in 200 mL of water. The load provides 0.1385 mol glucose and 0.1385 mol fructose.; Ingestion of the slowly digestable disaccharide isomaltulose (47.5 g) dissolved in 200 mL of water. The load provides 0.1385 mol glucose and 0.1385 mol fructose.; Ingestion of the disaccharide sucrose (47.5 g) and the alpha glucosidase inhibitor acarbose dissolved in 200 mL of water. The load provides 0.1385 mol glucose and 0.1385 mol fructose.
Intervention MeSH terms: Acarbose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Glucagon-Like Peptide 1; Carbohydrates; Gastric bypass; Bariatric Surgery; Overweight
Mirabegron in Parkinson Disease and Impaired Cognition
Condition: Parkinson Disease; Overactive Bladder; Impaired Cognition
MeSH terms: Parkinson Disease; Urinary Bladder, Overactive; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      There is a high prevalence of OAB symptoms among patients with Parkinson's disease and a lack
      of pharmacotherapies with an acceptable side effect profile. Specifically, available
      anticholinergic medications have a high risk of cognitive side-effects, which preclude their
      use in PD patients with CI. PD can also cause a number of non-motor symptoms that are likely
      to be adversely affected by the currently available anticholinergic agents. Mirabegron is the
      first pharmacologic treatment which may not exacerbate CI, constipation, orthostatic
      hypotension (OH), somnolence, and dry mouth in PD.
    


Intervention name(s): mirabegron; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Myrbetriq
Intervention MeSH terms: Mirabegron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: mirabegron
Effect of Xiaoer Jiebiao Oral Liquid on Hand-foot-mouth Disease
Condition: Handfoot-mouth Disease
MeSH terms: Foot-and-Mouth Disease; Hand, Foot and Mouth Disease; Mouth Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a single-blinded randomized trial aiming to evaluate the effectiveness of Xiaoer
      Jiebiao Oral liquid in combination with Ribavirin treatment on patients with hand-foot-mouth
      disease compared with the controlgroup that recieve only libavirin treatment.
    


Intervention name(s): Ribavirin plus Xiao'er jiebiao oral liquid; Ribavirin
Intervention type(s): Drug; Drug
Intervention description(s): For mild (Phase I) patients: recommended treatment according to naitonal guildeline for treatment of mouth-foot-hand diseases 2010, including ①treatment for control symptoms ② ribavirin 15mg/kg/d（ diluted in 100ml 5%GS），qd, ivgg, in combination using of Xiaoer jiebiao oral liquid 5 ml, bid for children aged 1-2 years, tid for children aged 3-5 years.
For moderate (Phase II) patients:
recommended treatment according to naitonal guildeline for treatment of mouth-foot-hand diseases 2010, including ①treatment for control symptoms ② ribavirin 15mg/kg/d（ diluted in 100ml 5%GS），qd, intravenous drip, in combination using of Xiaoer jiebiao oral liquid 5 ml, bid for children aged 1-2 years, tid for children aged 3-5 years.③anti-intracranial pressure treatment: mannitol 2~5ml/kg,iv, Bid~tid）; For mild (PhaseI) patients : recommended treatment according to naitonal guildeline for treatment of mouth-foot-hand diseases 2010, including ①treatment for control symptoms ② ribavirin 15mg/kg/d（ diluted in 100ml 5%GS），qd, intravenous drip.
For moderate (PhaseII) patients: recommended treatment according to naitonal guildeline for treatment of mouth-foot-hand diseases 2010, including ①treatment for control symptoms ② ribavirin 15mg/kg/d（ diluted in 100ml 5%GS），qd, intravenous drip, in combination using of Xiaoer jiebiao oral liquid 5 ml, bid for children aged 1-2 years, tid for children aged 3-5 years.③anti-intracranial pressure treatment: mannitol 2~5ml/kg, iv, Bid~tid）
Intervention MeSH terms: Ribavirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Mild and Moderate Severe Patients With hand_foot-mouth Disease
Physical Therapy on Non-structural Medial Elbow Pain
Condition: Elbow Injuries and Disorders; Neuritis, Ulnar; Neuritis, Brachial; Neuritis; Nerve Root; Neuritis Median Nerve
MeSH terms: Neuritis; Brachial Plexus Neuritis; Ulnar Neuropathies; Elbow Injuries
Study type: Interventional

Summary: 
      This study is investigating the effect of using a regional interdependence approach of
      managing non-structural elbow pain with physical therapy.
    

Detailed description: 
      Potential patients will be referred for physical therapy with elbow nerve pain arising from a
      non-structural lesion. We believe by addressing spine and trunk posture and mobility we can
      relieve elbow pain associated with a nerve compression with physical therapy.

      Patients will be put on a staged exercise program to regain spinal mobility and strengthen
      proximal core musculature and scapular musculature. Manual therapy to facilitate mobility
      will be incorporated. Patients will undergo standard physical therapy by an unblinded
      therapist until resolution of symptoms.
    

Intervention name(s): Rehabiltiation using exercise and manual therapy
Intervention type(s): Other
Intervention description(s): A licensed Physical Therapist will provide manual therapy to help restore spinal and scapular mobility. In association with this patients will be prescribed home exercises using a phased approach.
Phase 1 to gain mobility of the spine and scapular motor control Phase 2 to gain shoulder mobility to strengthen scapular and spine musculature Phase 3 shoulder strengthening with long lever arms.
Intervention model: Single Group Assignment
Intervention model description: Cohort longitudinal
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Regional Interdependence; Posture; Neural Tension; Physical Therapy
Long-term Effect of θ Burst Magnetic Stimulation on Clinical Symptoms of Alzheimer Disease
Condition: Repetitive Transcranial Magnetic Stimulation
MeSH terms: Alzheimer Disease
Study type: Interventional

Summary: 
      This was a randomized, single-blind, parallel, placebo-controlled clinical trial assessing
      the efficacy of neuronavigational TBS among patients with AD. Fourty late-onset AD were
      included in the study, all the patients were divided into TBS groups and drug treatment
      group. Drug intervention group AD patients with drug regimen (donepezil 5mg / d) and primary
      care guidance, once every three months follow-up. TBS group is treated with TBS (a course of
      treatment every 3 months); after completing 4 treatments/follow-ups a year, evaluate the
      changes in MoCA, other clinical symptoms and multi-domain cognition tests, and brain Changes
      in structure and function.
    


Intervention name(s): θ burst transcranial magnetic stimulation; Pharmacotherapy
Intervention type(s): Other; Drug
Intervention description(s): In addition to drug therapy, TBS supplementary therapy was given every 3 months.The TBS parameters were as follows: 3 pulses, 50 Hz bursts given every 200 ms (at 5 Hz), and an intensity of 70% of the resting motor threshold, as measured from the right first dorsal interosseous muscle using a handheld 70 mm figure-of-eight coil. Take a course every 10 weeks .; Stable doses of cholinesterase inhibitors were given and the patients were followed up every three months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MTPS9579A in Patients With Asthma Requiring Inhaled Corticosteroids and a Second Controller
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase IIa, randomized, placebo-controlled, double-blind, multicenter, two-arm study
      to evaluate the efficacy, safety, and pharmacokinetics of MTPS9579A as an add-on therapy in
      patients with uncontrolled moderate to severe asthma who are receiving daily ICS therapy and
      at least one of the following additional controller medications: long-acting beta-agonist
      (LABA), leukotriene modulator (leukotriene modifier [LTM] or leukotriene receptor antagonist
      [LTRA]), long-acting muscarinic antagonist (LAMA), or long-acting theophylline preparation.
    


Intervention name(s): MTPS9579A; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): MTPS9579A IV infusion will be administered at the randomization visit (Week 2), Week 6, and every 4 weeks through Week 46.; Placebo matching MTPS9579A will be administered at the randomization visit (Week 2), Week 6, and every 4 weeks thereafter through Week 46.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Prucalopride in Patients With Severe Chronic Idiopathic Constipation
Condition: Chronic Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether prucalopride is safe and effective in
      patients with severe chronic constipation.
    

Detailed description: 
      This is a phase II trial with a parallel-group design, consisting of a run-in phase (phase
      I), followed by a placebo controlled double-blind phase (phase 2). Patients will receive
      either R093877 4 mg or placebo o.d. for a period of 4 weeks.

      Phase 1 is a run-in period of 4 weeks duration, during which the bowel habit is documented
      and the existence of constipation determined. If the definition of constipation was not met
      during the 4 weeks of the run-in period, double-blind treatment will not be started.

      Phase 2 is a double-blind, randomized, placebo-controlled phase, in which patients will be
      treated for 4 weeks with either 4 mg of R093877 or placebo given o.d. (two capsules of 2 mg
      are taken before breakfast).
    

Intervention name(s): prucalopride; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 4 mg o.d.; Placebo o.d.
Other intervention name(s): Resolor
Intervention MeSH terms: Prucalopride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Constipation; Prucalopride; Colonic Transit Time
GLP-1 and Microvascular Function in Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Some gut hormones, called incretins, stimulate insulin production in order to control sugar
      levels but also activate brain centres and signal to stop eating. Current administration of
      incretin-based therapies mimicking these gut hormones is by subcutaneous (just under the
      skin) injection and has been routinely available for diabetic patients for more than 4 years.
      It is an effective treatment for the lowering of blood glucose with an average weight loss of
      about 3-4kg.Recent evidence, from animal studies and limited human studies, suggests that
      incretins based treatments may also have beneficial effects on blood vessel function.
      However, it is not known whether this effect is by direct action on the blood vessel
      independent of an improvement of latent inflammation which is typically associated with
      weight loss or an anti-inflammatory effect of the incretin treatment itself. The aim of this
      study is to determine whether the incretin-based diabetes treatment with the GLP-1
      (Glucagon-like peptide 1) analogue Liraglutide (also known as Victoza), which mimics the
      actions of incretins, improves blood vessel function in individuals with type 2 diabetes. It
      will determine whether the improvement in blood vessel function is independent of the effect
      of weight loss and changes in inflammation. This by the study of vascular function before and
      after 4 months of Victoza treatment in subjects with Type 2 diabetes in comparison with 1)
      participants randomized to hypo-caloric diet to achieve a similar weight loss than with
      Victoza and 2) participants randomized to treatment with once daily aspirin. Comprehensive
      assessment of blood vessel function, body fat distribution and metabolic profile at baseline
      and at the end of the treatment phase will be combined with assessments of inflammation
      markers in blood and in fat tissue biopsies.
    


Intervention name(s): Liraglutide; diet; Aspirin
Intervention type(s): Drug; Other; Drug
Intervention description(s): Administered once daily; reduction of caloric intake to promote weight loss; 300mg of Aspirin per day
Other intervention name(s): Victoza; GLP-1 analogue; caloric restriction
Intervention MeSH terms: Aspirin; Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: GLP-1 analogues; microvascular; inflammation; fat tissue; clot structure
A Study of Ponesimod in Healthy Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of steady-state carbamazepine (CBZ; a
      strong pregnane X receptor [PXR] agonist) on the pharmacokinetics (PK) of ponesimod following
      a gradual up-titration regimen in healthy adult participants.
    


Intervention name(s): Ponesimod; Carbamazepine
Intervention type(s): Drug; Drug
Intervention description(s): Ponesimod tablet will be administered orally.; Carbamazepine tablet will be administered orally.
Other intervention name(s): JNJ-67896153; ACT-128800; Ponvory; Tegretol
Intervention MeSH terms: Carbamazepine; Ponesimod
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Progesterone Support of FET
Condition: Frozen Embryo Pregnancy Rate
Study type: Observational

Summary: 
      There have been two very common forms of progesterone administration that have been used
      during ovulation induction, in vitro fertilization (IVF) and embryo transfers. There are
      currently no randomized clinical trials to demonstrate which method of progesterone
      administration is more effective for frozen embryo transfer. We raise the question: Is there
      a difference between the two accepted methods of progesterone administration, intramuscular
      and vaginal suppositories, for frozen embryo transfer? Studies for fresh embryo transfer
      after in vitro fertilization, have demonstrated that there is not a difference between the
      two methods of progesterone administration. We will evaluate the question for frozen embryo
      transfer.
    


Intervention name(s): Progesterone Vaginal Suppositories; Intramuscular Progesterone-in-Oil
Intervention type(s): Drug; Drug
Intervention description(s): Progesterone Vaginal Suppositories 200 mg three times daily for 10 weeks following embryo transfer; Progesterone-in-Oil 50 mg IM once daily for 10 weeks following embryo transfer
Intervention MeSH terms: Progesterone
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women having a frozen embryo transfer.
      
Keywords: FET; Progesterone Support; Frozen Embryo Transfer
Intramuscular Ketorolac at Two Single-Dose Regimens
Condition: Musculoskeletal Pain; Analgesia; Adverse Event
MeSH terms: Musculoskeletal Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to evaluate a single 15 mg intramuscular (IM) dose of ketorolac
      for analgesic non-inferiority versus a single 60 mg IM dose for the treatment of acute MSK
      pain in a military emergency department (ED) that services Department of Defense (DoD),
      Department of Veteran Affairs (VA), and foreign military beneficiaries
    

Detailed description: 
      The primary purpose of this study is to evaluate a single 15 mg IM dose of ketorolac for
      analgesic non-inferiority versus a single 60 mg IM dose for the treatment of acute MSK pain
      in a military ED that services Department of Defense (DoD), Department of Veteran Affairs
      (VA), and foreign military beneficiaries. The authors chose to evaluate 15 mg rather than the
      previously identified 10 mg dose for ease of administration as ketorolac is manufactured in
      15 mg/mL, 30 mg/mL, and 60 mg/2mL vials in the U.S. The dose of ketorolac served as the
      primary independent variable for the study and the change in Visual Analog Scale (VAS) score
      served as the dependent variable. Prescribing the minimally effective doses of NSAIDs is
      pertinent to prevent and reduce the number of adverse events. Thus, the secondary outcome
      assessed for the dose-dependence of subjective and objective adverse events with ketorolac.
    

Intervention name(s): Ketorolac Injection 15 mg; Ketorolac Injection 60 mg
Intervention type(s): Drug; Drug
Intervention description(s): A single dose of 15 mg ketorolac administered intramuscularly.; A single dose of 60 mg ketorolac administered intramuscularly.
Other intervention name(s): toradol; ketorolac tromethamine; ketorolac; Toradol; ketorolac tromethamine; ketorolac
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single blinded, randomized, non-inferiority
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: emergency department; ketorolac; musculoskeletal pain; non-inferiority; adverse event
A Study to Determine the Safety & Efficacy of ZPL-5212372 in Healthy Subjects and in Subjects With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A Randomised, Adaptive Design, Double-Blind (3rd Party Open), Placebo Controlled, Sequential
      Group Study to Determine the Safety,Tolerability, Pharmacokinetics and Efficacy of Twice
      Daily Application of a Topical ZPL-5212372 (1.0% w/w) Ointment Administered for up to 2 Weeks
      in Adult Healthy Volunteers and Patients with Moderate to Severe Atopic Dermatitis
    

Detailed description: 
      This study was a randomised, adaptive design, double blind (3rd party open), placebo
      controlled, sequential group study in both healthy volunteers and patients with moderate to
      severe AD. This study was divided into 3 separate, sequential cohorts:

        -  Cohort 1 were to assess safety, toleration and pharmacokinetics (PK) with intensive
           monitoring as in-patients over 7 days of dosing in healthy volunteers.

        -  Cohort 2 were to assess safety, toleration and PK with intensive monitoring as
           in-patients over 7 days of dosing in moderate to severe AD patients.

        -  Cohort 3 were to assess efficacy, safety, toleration and PK as out-patients over 14 days
           of dosing in moderate to severe AD patients.

      Subjects received 1.0% (w/w) ZPL-5212372 or matched placebo ointment topically, twice daily.
    

Intervention name(s): ZPL-5212372 1% w/w Ointment BID; Placebo Ointment BID
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment