bioihbjkbjnl/mcl2 huggingface dataset:
Pilot Study of the Spiration IBV™ System
Condition: Emphysema
MeSH terms: Emphysema
Study type: Interventional
Phase: Phase 2

Summary: 
      The Spiration Intra-Bronchial Valve is intended for use as a minimally invasive treatment for
      severe emphysema, using standard bronchoscopy. The valve is designed to limit airflow to a
      selected portion of the lung, producing a reduction in lung volume, which may improve
      pulmonary function in patients with emphysema.
    

Detailed description: 
      This pilot study is an open enrollment, prospective study with each subject serving as their
      own control. The sponsor may attempt to include the data from this study in the statistical
      analysis of the pivotal study. This proposal shall be evaluated at the conclusion of the
      pilot study.

      PATIENT POPULATION Patients with severe emphysema are eligible to be screened for enrollment
      in this study. In this initial pilot study, eligible subjects will have severe,
      heterogeneous, predominantly upper lobe emphysema, as defined by the American Thoracic
      Society (ATS) 1 and the NETT Research Group.2

      These subjects also will be patients who have been screened as potential candidates for LVRS,
      but who have been excluded from surgical treatment due to a failure to satisfy the inclusion
      and exclusion criteria established by the NETT Research Group for LVRS.2 Patients also will
      be able to tolerate a flexible bronchoscopy procedure.

      Patients who have been screened and accepted for a lung transplant procedure or LVRS, and are
      currently registered or scheduled for such a procedure, are not eligible for enrollment in
      this pilot study.

      Patients with an FEV1 < 20% predicted and either homogeneous emphysema or DLCO < 20% will be
      excluded from enrollment in this pilot study.3

      Patients will be screened and enrolled until up to 115 subjects have undergone treatment with
      the IBV System. Up to 15 clinical centers will be selected to enroll and treat subjects.
    

Intervention name(s): Intra Bronchial Valve
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COPD
Anesthetic Depth and the Incidence of Emergence Agitation in Children Undergoing Strabismus Surgery
Condition: Strabismus
MeSH terms: Psychomotor Agitation; Strabismus; Emergence Delirium
Study type: Observational

Summary: 
      This study evaluates the association between the depth of general anesthesia and the
      occurrence of emergence agitation (EA). The investigators hypothesized that optimal level of
      anesthetic depth could decrease the incidence of EA in children undergoing strabismus surgery
      compared to the deep level of anesthetic depth.
    

Detailed description: 
      EA is characterized by dissociated state of consciousness, in which the children are
      inconsolable, irritable, uncooperative, thrashing, crying, moaning or incoherent.

      Several predisposing factors for EA include post-operative pain, rapid emergence from general
      anesthesia, use of volatile anesthetics, type and site of operation (usually head & neck
      surgeries), agitation on induction, airway obstruction, hyperthermia or hypothermia.

      The effect of anesthetic depth on the EA has rarely been evaluated in pediatric population,
      even though postoperative delirium or postoperative cognitive dysfunction (POCD)corresponds
      to the EA identically.

      In this study, the concentration of anesthetics was not managed on purpose to lower the BIS
      score. Patients were allocated to each group based on the result of average BIS score during
      the operation.
    

Intervention name(s): BIS
Intervention type(s): Device
Intervention description(s): BIS monitoring provides the patient's depth of consciousness, enables us to monitor safe, optimal anesthesia for each patient.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients, aged between 3 and 5 years, scheduled for strabismus surgery
      
Keywords: anesthetic depth; emergence agitation
A Trial of Dexmedetomidine Hydrochloride Nasal Spray in Preoperative Sedation of Children
Condition: Preoperative Sedation
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is being conducted to evaluate the efficacy, safety and the population
      pharmacokinetic characteristics of dexmedetomidine hydrochloride nasal spray for preoperative
      sedation in children
    


Intervention name(s): Dexmedetomidine hydrochloride nasal spray; Dexmedetomidine hydrochloride nasal spray blank preparation.
Intervention type(s): Drug; Drug
Intervention description(s): In the low weight group, 18 subjects will receive a low dose of dexmedetomidine nasal spray.
In the high weight group, 18 subjects will receive a high dose of dexmedetomidine nasal spray.; In the low weight group, 6 subjects will receive dexmedetomidine hydrochloride nasal spray blank preparation.
In the high weight group, 6 subjects will receive dexmedetomidine hydrochloride nasal spray blank preparation.
Other intervention name(s): Placebo
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Dexmedetomidine hydrochloride nasal spray compared with placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Copenhagen Study of Obese Patients With Ischemic Heart Disease Undergoing Low Energy Diet or Interval Training
Condition: Ischemic Heart Disease; Obesity
MeSH terms: Heart Diseases; Myocardial Ischemia; Coronary Artery Disease; Ischemia
Study type: Interventional

Summary: 
      The purpose of the study is to make a head-to-head comparison of weight loss and interval
      training as methods of secondary prevention in overweight patients with ischemic heart
      disease.
    

Detailed description: 
      In western countries 80 % of patients with ischemic heart disease (IHD) are overweight (BMI >
      25). Weight loss using a low energy diet (LED, 800 - 1000 kcal/day) has been shown to induce
      a considerable weight loss in obese but otherwise healthy patients and to reduce the risk of
      cardiovascular disease and diabetes in these subjects. Additionally, a British study using a
      very low energy diet (VLED, 600 kcal/day) to obtain weight loss, has shown that subject with
      diagnosed type 2 diabetes had their blood glucose normalized after an 8 week VLED. However,
      the effect of LED has never been examined in overweight patients with IHD.

      Several studies have shown that patients with IHD have a beneficial effect of exercise
      training regarding mortality and reduction in cardiovascular risk factors. A Norwegian group
      has shown that aerobic interval training results in the biggest increase in maximal oxygen
      uptake (VO2max). A high VO2max is correlated to decreased mortality in patients with IHD.

      In conclusion, weight loss and exercise are known strategies in preventing progression of IHD
      and development of type 2 diabetes in these patients, however a head-to-head comparison of
      the two methods has never been made and it is unknown which intervention is the most
      effective in improving cardiovascular risk profile. Furthermore, several mechanisms behind
      the known beneficial effect of these interventions are unknown.
    

Intervention name(s): Interval Training; Weight Loss
Intervention type(s): Other; Other
Intervention description(s): Interval training (IT) on an exercise bike 3 times a week, for the first 12 weeks, followed by 40 weeks of IT 2 times a week on exercise bike. Each training session consists of active intervals with a total duration of 16 minutes (durations intervals between 1 and 4 minutes) at 90% of maximal heart rate. Active intervals are separated by active pauses at 60% of maximal heart rate.; Low calorie diet approx. 1000 kcal/day for 8 - 10 weeks to obtain a 10 - 15 % weight loss.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Interval Training; Weight Loss; Secondary Prevention; Rehabilitation; Cardiovascular Risk Factors
Safety, Efficacy and Pharmacokinetic Study of Allegra in Pediatric Patients With Perennial Allergic Rhinitis (PAR)
Condition: Rhinitis Perennial
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Primary Objective:

      - To evaluate safety (4 weeks)

      Secondary Objectives:

        -  To evaluate the long-term safety (12 weeks)

        -  To evaluate the efficacy

        -  To characterize the pharmacokinetic profile
    

Detailed description: 
      The study consists of four phases: up to 9-day screening phase, main 4-week treatment phase,
      up-to 8-week extension phase, and up-to 5-day post-treatment phase.
    

Intervention name(s): fexofenadine/Allegra (M016455)
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form:dry syrup formulation to be suspended in water
Route of administration: oral
Intervention MeSH terms: Fexofenadine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of Fixed Dose Combination (FDC) of Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray (Molo; Also Referred as GSP 301) in the Treatment of Seasonal Allergic Rhinitis (SAR)
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 2

Summary: 
      A single-center, double-blind, placebo-controlled study of FDC olopatadine hydrochloride and
      mometasone furoate nasal spray (Molo; also referred as GSP 301) was conducted in subjects
      with seasonal allergic rhinitis. In this study, the efficacy and safety of two regimens (BID
      and QD) of the FDC (i.e. Molo 1 and Molo 2) were evaluated compared to placebo nasal spray,
      DYMISTA® and PATANASE®.
    


Intervention name(s): Molo 1 (also referred as GSP 301-2 NS); Molo 2 (also referred as GSP 301-1 NS); Placebo nasal spray; DYMISTA nasal spray; PATANASE nasal spray
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Olopatadine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: SAR
Phytosterol Supplementation and Lipoprotein Subfractions
Condition: Hypercholesterolemia; Primary Prevention
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      The goal of this clinical trial was to evaluate the effects of phytosterol supplementation to
      the diet on lipids, LDL and HDL subfractions, and on the quality of LDL in apparently healthy
      subjects.

      The main questions it aims to answer are:

        -  do phytosterols reduce LDL-cholesterol and modify LDL and HDL subfractions?

        -  do phytosterols modify the quality of LDL?

      Participants were aleatory selected to diet alone (D) or diet plus phytosterols (DP, 2.6 g
      divided in two doses, with meals) for 12 weeks, followed by a 7-day washout period, where
      treatments were switched for another 12-weeks.
    

Detailed description: 
      Military police from the ROTA (Rondas Ostensivas Tobias de Aguiar, N=60), with
      hypercholesterolemia in primary prevention were recruited. Of those, 27 did not meet entry
      criteria, 10 were excluded for not following the protocol. Twenty-three individuals were
      aleatory selected to diet alone (D) or diet plus phytosterols (DP, 2.6 g divided in two
      doses, with meals) for 12 weeks (w), followed by a 7-day washout period, where treatments
      were switched for another 12-w.

      Study was prospective, randomized, open label, cross-over, with parallel arms and blinded
      endpoints.

      Anthropometry, food consumption and laboratory parameters were evaluated every 12-w.

      HDL and LDL subfractions were analyzed by the electrophoresis system in polyacrylamide gel
      (Lipoprint System®).

      Plasma LDL was separated by ultracentrifugation and the quality of the LDL analyzed by
      nonlinear optical response (Z-scan and UV-vis spectroscopy techniques).
    

Intervention name(s): Phytosterol supplements
Intervention type(s): Dietary Supplement
Intervention description(s): Participants were randomized into two groups to receive diet plus phytosterols (DP) for 12 weeks, followed by a 7-day washout period with a second period of intervention, where treatments were switched, and participants received diet alone (D) and were followed for another 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, open-label, crossover intervention study conducted with participants selected by the investigators, and invited to participate in the study.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Phytosterols; Lipoproteins; LDL-subfractions; HDL-subfractions
Post-Marketing Surveillance Study of Aripiprazole in Patients With Autism
Condition: Autism
MeSH terms: Autistic Disorder
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of aripiprazole in
      patients with autism in the real world clinical setting in Japan.
    


Intervention name(s): Aripiprazole oral product
Intervention type(s): Drug
Intervention description(s): oral administration of aripiprazole
Intervention MeSH terms: Aripiprazole
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        naive patients with aripiprasole
Dose Ranging Pharmacokinetics and Pharmacodynamics Study With Mepolizumab in Asthma Patients With Elevated Eosinophils
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      A multi-center, randomized, open-label, parallel-group, repeat dose study in asthma patients
      with elevated eosinophils. Eligible subjects will receive 3 doses (28 days apart) of
      mepolizumab given intravenous (IV) or subcutaneously (SC). Blood samples for safety,
      pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity analysis, as well as
      safety/tolerability assessments will be collected throughout the study
    

Detailed description: 
      Mepolizumab (SB-240563) is a humanized monoclonal antibody that blocks human interleukin 5
      (IL-5) from binding to its receptor. Mepolizumab is currently under development for severe
      refractory asthma and a Phase IIB dose-ranging study using the IV route of administration is
      currently on-going. This study will be a multi-center, randomized, open-label,
      parallel-group, repeat dose study conducted in approximately 65 subjects with established
      asthma and elevated blood eosinophil levels. Dosing will occur on three occasions, every four
      weeks [Day 1, Day 28 (+/- 3 days) and Day 56 (+/- 3 days)]. Blood samples for safety,
      pharmacodynamics (PD), pharmacokinetics (PK) and immunogenicity analysis, as well safety and
      tolerability assessments will be collected/assessed throughout the study. Each subject will
      participate in the study for up to approximately 22 weeks, including screening, dosing and
      follow-up.
    

Intervention name(s): Mepolizumab
Intervention type(s): Biological
Intervention description(s): Monoclonal antibody
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Intraperitoneal and Intravenous Lignocaine on Pain Relief Following Laparoscopic Cholecystectomy
Condition: Pain, Postoperative; Analgesic Requirement; Stress Response; Return of Bowel Activity; Inadequate or Impaired Respiratory Function
MeSH terms: Respiratory Insufficiency; Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Laparoscopic Cholecystectomy is the treatment of choice for patients with symptomatic gall
      stones. For pain relief following laparoscopic cholecystectomy both intraperitoneal and
      intravenous administration of lignocaine has been used. But it is not clear from the existing
      literature which form of administration is more effective for pain relief. Hence this study
      has been undertaken with the following hypothesis : Intravenous lignocaine is superior to
      intraperitoneal lignocaine for postoperative pain relief and minimizing the stress response
      in laparoscopic cholecystectomy.
    

Detailed description: 
      Laparoscopic Cholecystectomy is the treatment of choice for patients with symptomatic gall
      stones. For pain relief following laparoscopic cholecystectomy both intraperitoneal and
      intravenous administration of lignocaine has been used. But it is not clear from the existing
      literature which form of administration is more effective for pain relief. Hence this study
      has been undertaken with the following hypothesis : Intravenous lignocaine is superior to
      intraperitoneal lignocaine for postoperative pain relief and minimizing the stress response
      in laparoscopic cholecystectomy.

      In this study the effect of intraperitoneal and intravenous lignocaine will be assessed based
      on the postoperative pain scores, total analgesic requirement, stress response in the form of
      total leukocyte count, c-reactive protein levels,return of bowel activity.
    

Intervention name(s): Intraperitoneal Lignocaine; Intravenous Lignocaine
Intervention type(s): Drug; Drug
Intervention description(s): Patients will receive 100 ml of 0.2% lignocaine; Intravenous group patients will receive 1.5mg/kg of lignocaine as bolus dose at induction and 2mg/kg/hour as continuous infusion until one hour after surgery
Other intervention name(s): IP Lignocaine; IV lignocaine
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lignocaine; Laparoscopic cholecystectomy; Pain relief
The Evaluation of the Efficacy and Safety of Donepezil Hydrochloride in Subjects With Mild Cognitive Impairment (MCI)
Condition: Memory Loss
MeSH terms: Memory Disorders; Amnesia; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      To investigate the efficacy and safety of donepezil in individuals with mild cognitive
      impairment on measures of cognition, global function and behavior.
    


Intervention name(s): Donepezil Hydrochloride; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subects will receive a starting dose of 5 mg orally. Dose-escalation from 5 mg to 10 mg will occur at the Week 9 Visit.; Subjects will receive matching placebo tablets.
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Cognitive impairment; Memory Loss
Effect of Therapeutic Massage on Sleep Quality and Stress Levels in Women With Breast Cancer
Condition: Sleep Disturbance; Anxiety
MeSH terms: Dyssomnias; Parasomnias
Study type: Interventional

Summary: 
      This is a randomized control trial to test the effectiveness of therapeutic massage on the
      sleep quality and the stress levels in women that have completed their treatment for breast
      cancer.
    

Detailed description: 
      The period following the completion of treatment for breast cancer (but also for any other
      type of cancer as well) is once that is accompanied by an increased uncertainty. This can
      often trigger increased anxiety levels and sleep disturbances. This trial tests the
      effectiveness of therapeutic massage as a non pharmaceutical intervention that can increase
      the management of stress and sleep disturbances during this period of time.
    

Intervention name(s): Therapeutic massage; Sham massage
Intervention type(s): Other; Other
Intervention description(s): Massage therapy involves the administration of combinations of specific physical manipulations applied in a systematic way, with varying intensity, direction, rate, and rhythm, to the soft tissues of the body.; Sham massage involves only light touch massage in a non systematic way
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Effect of Salsalate on Bed Rest-Induced Vascular Dysfunction
Condition: Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional
Phase: Phase 1

Summary: 
      Physical inactivity induces vascular dysfunction and glucose intolerance during five days of
      bed rest. This study will investigate the effects of salsalate on these responses. Subjects
      will be randomized to treatment with salsalate or placebo for four days prior to initiation
      of bed rest. Vascular function in the brachial artery will be determined by ultrasound prior
      to treatment and before and after the 5-day bed rest protocol. We hypothesize that treatment
      with salsalate will be associated with protection again the development of glucose
      intolerance and vascular dysfunction in this setting.
    


Intervention name(s): salsalate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Salsalate 3-4 grams per day as tolerated for nine days
Intervention MeSH terms: Salicylsalicylic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Study of Subcutaneous and Intravenous ALXN1720 With and Without rHuPH20 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the safety, tolerability, pharmacokinetics,
      pharmacodynamics, and immunogenicity of ALXN1720 administered subcutaneously (SC) or
      intravenously (IV).
    

Detailed description: 
      Participants will be randomized in a 3:1 ratio to receive the active treatment or placebo.

      The study will be conducted in healthy adult participants, including participants of Japanese
      descent.
    

Intervention name(s): ALXN1720 SC; ALXN1720 IV; rHuPH20; Placebo SC; Placebo IV
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): ALXN1720 will be administered via SC route.; ALXN1720 will be administered via IV route.; rHuPH20 will be administered via SC route.; Placebo will be administered via SC route.; Placebo will be administered via IV route.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ALXN1720; Safety; Pharmacokinetics; Pharmacodynamics