bioihbjkbjnl/mcl2 huggingface dataset:
Evaluations of Cardiopulmonary Function and Motor Development of Congenital Heart Disease
Condition: Congenital Heart Disease in Children; Infant Development; Infant Conditions; Motor Neuropathy; Motor Delay; Cardiopulmonary
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Interventional

Summary: 
      In this single-center, randomized controlled trial, patients (4-8 months) with CHD were
      randomly assigned to either a recovery group (home-based rehab exercise periodically)
      supervised by cellphone APP or to a control group. Left ventricular ejection fractions
      (LVEF), the rate of increase in heart rate (rHRI), and the rate of recovery heart rate (rHRR)
      were measured for representing cardiopulmonary capacity. The Alberta test and
      Neuro-intelligence Scale were used to evaluate their motor developmental outcomes. This study
      verified the feasibility of this rehab method and indicated that 6-month home-based exercise
      training can improve cardiopulmonary endurance and motor developmental level in infant CHD
      patients.
    


Intervention name(s): exercise-guidance on rehab APP
Intervention type(s): Behavioral
Intervention description(s): Training motions included sitting balance, hand support, crawling and squatting training12-14 were scheduled for 1 to 3 months postoperatively, moreover, climbing over obstacles was for 3 to 6 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: infant; rehab management APP; home-based exercise; cardiopulmonary endurance; motor developmental level
MARIGOLD Study: A Study of RO4917523 Versus Placebo as Adjunctive Therapy in Patients With Major Depressive Disorder and an Inadequate Response to Ongoing Antidepressant Therapy
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      This randomized, double-blind, placebo-controlled, parallel group study will evaluate the
      safety and efficacy of RO4917523 as adjunctive therapy in patients with major depressive
      disorder and an inadequate response to ongoing antidepressant therapy. Anticipated time on
      study treatment is 6 weeks with a 3-week follow-up.
    


Intervention name(s): Placebo; RO4917523 0.5 mg; RO4917523 1.5 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Matching RO4917523 placebo orally daily, 6 weeks; 0.5 mg orally daily, 6 weeks; 1.5 mg orally daily, 6 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Assess Changes in Cigarette Consumption During a Switch to Very Low Nicotine Cigarettes
Condition: Tobacco Use
Study type: Interventional

Summary: 
      This study evaluates the impact of switching from usual brand cigarettes to very low nicotine
      cigarettes on cigarette consumption, smoking behavior, and biomarkers of exposure.
    

Detailed description: 
      Very low nicotine (VLN) cigarettes contain a 'non-additive' level of nicotine. This study
      will switch smokers from their usual brand to VLN cigarettes. Periodically during the study
      the investigators will collect blood and measure nicotine exposure and also other biomarkers
      to see what effect switching has. The participants will also use a diary to record number of
      cigarettes smoked. Cigarette butts will also be collected.
    

Intervention name(s): Non-Menthol Very Low Nicotine Cigarettes; Menthol Very Low Nicotine Cigarettes; Subject's UB non-mentholated filtered cigarettes; Subject's UB mentholated filtered cigarettes
Intervention type(s): Other; Other; Other; Other
Intervention description(s): King size non-menthol cigarettes containing 0.4mg nicotine /g tobacco; King size menthol cigarettes containing 0.4mg nicotine /g tobacco; King size non-menthol cigarettes; King size menthol cigarettes
Intervention MeSH terms: Menthol; Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Longitudinal ambulatory switching study
Masking: None (Open Label)
Primary purpose: Other
Keywords: Very Low Nicotine; Cigarette; VLN
Role of markErs in the progreSsion of dIabeteS in Obese paTIeNts
Condition: Obese Patients
MeSH terms: Obesity
Study type: Observational

Summary: 
      Obese patients will be enrolled from 2006 to 2014. The progression of diabetes mellitus will
      be observed (if any). Anthropometric and biochemical parameters will be evaluated.
    


Intervention name(s): Progression of diabetes
Intervention type(s): Other
Other intervention name(s): Variations of biochemical parameters
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Output patients with obesity
      
Keywords: Obesity; Diabetes Mellitus
The Conversion Therapy of Chemotherapy Plus Camrelizumab in Metastatic Gastric Cancer
Condition: Stomach Neoplasms
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Gastric cancer is one of the most common malignant tumors of the digestive tract. Gastric
      cancer patients diagnosed for the first time in China have a higher proportion of advanced
      stages and a higher postoperative metastasis rate.Studies have shown that patients with good
      pathological response after preoperative neoadjuvant therapy (such as tumor regression grade,
      TRG0 or 1) have a better prognosis.The purpose of this study is to treat patients with
      advanced gastric cancer who are difficult to perform R0 surgery with chemotherapy combined
      with immunotherapy. At the same time as the primary cancerous lesions are reduced, the
      distant metastatic lesions are effectively controlled in order to perform R0 surgery and to
      improve the survival rate of patients with advanced gastric cancer.
    

Detailed description: 
      The interventions include camrelizumab and chemotherapy selected based on the use of
      different metastatic sites as conversion therapy.
    

Intervention name(s): Camrelizumab; S-1; Oxaliplatin; Paclitaxel
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 200mg, intravenous drip administration, d1, every 3 weeks.; Oral, d1-14, every 3 weeks.; 130mg/m² intravenous drip administration, d1, every 3 weeks(For patients with liver and/or para-aortic lymph node metastasis).; Intraperitoneal paclitaxel 20 mg/m² and intravenous paclitaxel 50 mg/m² on days 1 and 8, every 3 weeks(For patients with peritoneal metastasis ).
Other intervention name(s): SHR-1210; Tegafur Gimeracil Oteracil Potassium Capsule
Intervention MeSH terms: Paclitaxel; Oxaliplatin; Tegafur
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: gastric cancer; metastasis; conversion therapy; immune checkpoint inhibitors; camrelizumab
Nocturnal Oxygen Therapy
Condition: Lung Diseases; Lung Diseases, Obstructive; Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the efficacy of long-term use of nocturnal oxygen therapy (12 hours) with that of
      continuous, low-flow oxygen therapy (24 hours) in patients with chronic hypoxic lung disease.
    

Detailed description: 
      BACKGROUND:

      Chronic obstructive pulmonary disease is a major health problem in the United States. In
      1975, it was the sixth leading cause of death. The economic impact of the disease in 1972
      amounted to $803 million in the direct costs of disability treatment, $3.05 billion in
      disability costs, and $645 million in lost earnings due to premature death.

      Motivated in part by the significant toll of this disease, a conference on the Scientific
      Basis of Respiratory Therapy, co-sponsored by the American Thoracic Society and the Division
      of Lung Diseases, examined the current status of the use of oxygen therapy in chronic lung
      disease. The proceedings of the conference, published in the American Review of Respiratory
      Disease (Vol. 110, No. 6, December 1974), included a recommendation for clinical studies that
      would provide a critical assessment of the role of nocturnal oxygen therapy in the treatment
      of patients with chronic obstructive pulmonary disease. Low-flow oxygen, administered
      continuously, was known to benefit some patients with chronic hypoxic lung disease. However,
      low-flow oxygen administration for long periods of time is cumbersome, confining, and
      expensive. If nocturnal oxygen administration could be unequivocally demonstrated to be
      efficacious, then the advantages of convenience and cost would have a favorable impact on
      treatment of patients, and a rationale could be developed for testing this therapy in a
      larger group of patients.

      The Planning Phase of the trial was initiated in September 1976. Patient recruitment began in
      May 1977. The Recruitment Phase lasted 24 months. The 203 patients in the trial were assigned
      randomly to nocturnal oxygen therapy (home) or continuous low-flow oxygen therapy.

      DESIGN NARRATIVE:

      Randomized, fixed sample. Two hundred and three patients were randomly assigned to at-home
      treatments of continuous oxygen therapy or nocturnal oxygen therapy. Endpoints related to
      quality of life, neuropsychological function, and respiratory function and capacity.
      Intervention lasted for 6 months to 3 years, with an average intervention of 19.3 months.
    

Intervention name(s): oxygen inhalation therapy
Intervention type(s): Procedure
Allocation: Randomized
Primary purpose: Treatment
Open-Label Study of the Long Term Tolerability and Safety of Atomoxetine in Children With FASD and ADD/ADHD
Condition: Fetal Alcohol Syndrome; Attention Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Hyperkinesis; Fetal Alcohol Spectrum Disorders; Syndrome; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      Determine if atomoxetine is safe and well tolerated by children with fetal alcohol syndrome.
    

Detailed description: 
      Abnormalities of attention, function, and activity level in children exposed to alcohol in
      utero share similarities and differences to children who do not have alcohol exposure.
      Previous psychological studies have examined either core attention deficit hyperactivity
      (ADHD) symptoms of hyperactivity, inattention, and impulsivity or hypothesized
      neuropsychological differences in children with fetal alcohol syndrome (FAS) and ADHD.
      Atomoxetine Hydrochloride is a non-stimulant medication used to treat ADHD. This study will
      determine if atomoxetine HCL significantly reduces symptoms of ADD/ADHD in children with
      fetal alcohol exposure.
    

Intervention name(s): Atomoxetine
Intervention type(s): Drug
Intervention description(s): Titrating with oral administration of 0.25 mg/kg, 0.50 mg/kg, 1.0 mg/kg, or 1.4 mg/kg once each morning with food.
Other intervention name(s): Brand Name: Strattera, Serial Number: 76306506, ACT
Intervention MeSH terms: Atomoxetine Hydrochloride
Intervention model: Single Group Assignment
Intervention model description: open label
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: fetal alcohol syndrome; attention deficit disorder; attention deficit disorder with hyperactivity; ADD; FAS; FASD; ADHD
Distal Protection Device in ST-elevation Myocardial Infarction (STEMI)
Condition: ST-segment Elevation Myocardial Infarction
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators examined the mechanism underlying the lack of benefit from distal
      protection and thrombus aspiration (DP-TA) in 126 patients with ST-elevation Myocardial
      Infarction (STEMI) in a prospective, randomized trial.
    

Detailed description: 
      Patients with first-diagnosed STEMI were randomly assigned to distal protection and thrombus
      aspiration (DP-TA) pretreatment during percutaneous coronary intervention (PCI) or
      conventional PCI (c-PCI).

      The primary endpoint was the remodeling index (RI), measured by cardiac magnetic resonance
      imaging (CMR) post-PCI and 6 months after PCI.

      Secondary endpoints, determined by CMR within 3 to 5 days after PCI, included the infarct
      ratio (infarct size to entire left ventricular [LV] size ) by delayed-enhancement (DE), area
      at risk (AAR) ratio (AAR to LV size) by T2 high-signal intensity , microvascular occlusion
      index (MVO) ratio (MVO to LV size) by DE, and myocardial salvage index (MSI, [AAR-infarct
      size] x 100/AAR).
    

Intervention name(s): distal protection and thrombus aspiration (The GuardWire Plus (Medtronic Inc.)); c-PCI
Intervention type(s): Device; Procedure
Intervention description(s): The GuardWire Plus (Medtronic Inc.): distal balloon occlusion and proximal thrombus aspiration; conventional PCI without Guard wire
Other intervention name(s): The GuardWire Plus (Medtronic Inc.); convenional PCI
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: ST-elevation myocardial infarction; percutaneous coronary intervention; cardiac magnetic resonance imaging; microvascular occlusion; myocardial salvage
Mepivacaine vs. Bupivacaine Spinal Anesthetic in Total Knee Arthroplasty
Condition: Anesthesia, Spinal; Arthroplasty, Replacement, Knee; Pain Management; Early Ambulation; Ambulatory Surgical Procedures
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if a shorter-acting spinal anesthetic called
      mepivacaine has advantages over a longer-acting medication called bupivacaine.
    

Detailed description: 
      Different medications last for different amounts of time and can be changed depending on the
      length of the procedure. A short acting spinal is generally used for procedures lasting less
      than 90 minutes. A longer acting medication would be any that lasts longer than 90 minutes.
      These medications not only block the signals that travel along the pain nerves, they also
      prevent the signals that tell the patients muscles to move. This means that after a total
      knee replacement a patient may delayed in their ability to get up and start walking early
      after surgery. Walking early in the recovery has been shown to decrease the rate of pulmonary
      embolism and death. Ambulating early is also important to prevent loss of strength,
      constipation, pneumonia and urinary retention.
    

Intervention name(s): Mepivacaine; Bupivacaine
Intervention type(s): Drug; Drug
Intervention description(s): This is a shorter acting spinal anesthetic as compared to the current standard of care at this institution.; This is the current standard of care at this institution and many centers. This is a longer acting spinal anesthetic compared to the study drug.
Other intervention name(s): CAS Number: 96-88-8; Carbocaine; Sensorcaine; Marcaine; CAS 38396-39-3
Intervention MeSH terms: Bupivacaine; Mepivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Trial to Test for Bioequivalence Between NN1045 and NN5401 in Subjects With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of the trial is to test for bioequivalence between
      two formulations of insulin degludec/insulin aspart (IDegAsp) to see if the efficacy and
      safety obtained with formulation 1 can be assumed identical for formulation 2.
    


Intervention name(s): insulin degludec/insulin aspart
Intervention type(s): Drug
Intervention description(s): Single injection of each formulation. The dose level will be 0.5 U/kg body weight (BW). The trial products will be administered subcutaneously (under the skin).
Other intervention name(s): IDegAsp
Intervention MeSH terms: Insulin; Insulin Aspart
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effect of Imipramine on Early Information Processing
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      We wanted to compare the relation of two different psychophysiological paradigms (PrePulse
      Inhibition of the startle response = PPI and P50 suppression) to each other. Additionally, we
      wanted to test the effect of the combined serotonin- and noradrenaline re-uptake inhibitor,
      imipramine, on these measures. The primary hypothesis was that PPI and P50 gating would not
      correlate with each other at baseline. The secondary hypothesis was that increased
      noradrenergic and serotonergic activity would disrupt PPI as well as P50 gating.
    

Detailed description: 
      Schizophrenic patients exhibit impairments in filtering of sensory information, as can be
      assessed by use of prepulse inhibition (PPI) of the acoustic startle response and P50
      suppression paradigms. In the treatment of negative symptoms or depressive syndromes during
      the course of schizophrenia antidepressants are often combined with antipsychotic medication.
      However, antidepressants increase monoaminergic activity, of which in turn it has been
      suggested to decrease sensory gating, although these presumptions are mostly based on results
      from animal studies. Currently, little is known about monoaminergic modulation of sensory
      filtering in humans, and the few reports that can be found in literature show discrepancies
      with animal studies. The current study was designed to study the effects of increased
      monoaminergic activity on sensory filtering and habituation of healthy volunteers. In a
      double-blind, placebo controlled cross-over design, twenty healthy male volunteers will
      receive either placebo or a dose of 50 mg of imipramine (a dual acting antidepressant), after
      which they will be tested in a P50 suppression-, a PPI-, and a habituation of the startle
      reflex paradigm.
    

Intervention name(s): imipramine
Intervention type(s): Drug
Intervention description(s): Either 50 mg of imipramine or placebo will be administered to healthy male volunteers
Intervention MeSH terms: Imipramine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Psychophysiology; PPI; P50 suppression; Imipramine
Vitamin D Supplementation Study
Condition: Colorectal Cancer; Vitamin D Deficiency
MeSH terms: Colorectal Neoplasms; Vitamin D Deficiency
Study type: Interventional

Summary: 
      Patients with colorectal cancer will be recruited to undergo vitamin D supplementation in the
      peri-operative period. Vitamin D levels (25OHD) will be measured to assess response to
      supplementation.
    

Detailed description: 
      Patients with a new diagnosis of colorectal cancer will be recruited from colorectal
      outpatient clinics after confirmation of eligibility. Potential participants will be
      identified by their healthcare team comprising of clinical nurse specialist or surgeon and
      co-enrolment with portfolio studies including ALLEGRO and Prepare-ABC will be permitted.
      Patients undergoing neo-adjuvant therapy, already established on supplementary Vitamin D or
      with contra-indications to vitamin D supplementation will be excluded. After informed consent
      participants will undergo blood sampling at baseline (for 25OHD level and DNA) and given
      3200IU cholecalciferol (Fultium) per day to take until the time of surgery (median time from
      pre-operative clinic 4 weeks). Further blood sampling will be performed on the day of
      surgery, in the early post-operative period (1-2 days, 3-5 days, 6-9 days) and at the first
      post-operative clinic appointment. Where possible surplus serum from clinically indicated
      blood tests will be collected to assay 25OHD and reduce need to additional venesection.
    

Intervention name(s): Fultium
Intervention type(s): Dietary Supplement
Intervention description(s): 3200IU Fultium
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: colorectal; vitamin D
A Study to Evaluate AG-881 in Healthy Japanese and Non-Asian Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the pharmacokinetics (PK) and safety of AG-881 in
      healthy Japanese and Non-Asian participants after single oral doses of 10 mg and 50 mg of
      AG-881.
    


Intervention name(s): AG881
Intervention type(s): Drug
Intervention description(s): AG-881 tablets.
Other intervention name(s): Vorasidenib; AGI 23088; AGI 0023088
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetic study; AG-881
Aprepitant for Postoperative Nausea and Vomiting in Laparoscopic Hysterectomy
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      -  Gynecological surgery is associated with a high incidence of postoperative nausea and
           vomiting.

        -  NK1 receptor antagonists such as aprepitant appear to be highly effective for treating
           acute and delayed emesis, and yet understanding of the efficacy of different doses of
           aprepitant is limited.

        -  We performed a prospective, randomized, double-blinded placebo-controlled study of 123
           female adults scheduled for laparoscopic hysterectomy who received 80 mg aprepitant, 125
           mg aprepitant, or a placebo.
    

Detailed description: 
      123 female patients (ages 21-60) undergoing laparoscopic hysterectomy

        1. 80mg aprepitant

        2. 125mg aprepitant

        3. placebo

      Incidences of nausea, vomiting/retching, and use of rescue antiemetics were recorded at 0, 1,
      2, 24, and 48 h after surgery.
    

Intervention name(s): Aprepitant
Intervention type(s): Drug
Intervention description(s): Aprepitant 80 mg, Aprepitant 125 mg
Intervention MeSH terms: Aprepitant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Postoperative Nausea and Vomiting