bioihbjkbjnl/mcl2 huggingface dataset:
Sibutramine Versus Continuous Positive Airway Pressure (CPAP)in Obstructive Sleep Apnea (OSA) Patients
Condition: Obstructive Sleep Apnea; Obesity; Hypertension
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to observe if Sibutramine is effective in improving
      the symptoms and signs of sleep apnea in obese patients. The secondary objectives are to
      document the effects of Sibutramine on heart rate variability and 24-h arterial pressure
      values. We hypothesized that sibutramine will improve sleep disordered breathing, cardiac
      autonomic function and systemic blood pressure in obese patients with obstructive sleep apnea
      (OSA).
    


Intervention name(s): Sibutramine; CPAP
Intervention type(s): Drug; Device
Intervention description(s): The first group received sibutramine 10 mg for the first 4 weeks, at which time consideration of increasing dosage to 15 mg was re-evaluated in the case of insufficient weight loss (< 1.8 kg) over the first month of treatment.
Intervention MeSH terms: Sibutramine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Medically-tailored Meal Delivery Service on Changes in Hemoglobin A1c (HbA1c) in Patients With Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effect of medically-tailored meal delivery (10
      meals per week for 3 months) on glycemic control in diabetic patients.
    


Intervention name(s): Medically tailored meals
Intervention type(s): Dietary Supplement
Intervention description(s): 10 meals per week for 3 months
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
The Relationship Between the Neural Drive and Intrinsic Positive End-expiratory Pressure
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      To investigate the relation the nreural drive and intrinsic positive end-expiratory
      pressure(PEEPi) of the chronic obstructive pulmonary disease(COPD) patients with respiratory
      failure.In present study the PEEPi of COPD patients was increased by increasing the
      resistance of the respiratory system, the change of the neural drive was recorded.
    

Detailed description: 
      To investigate the relation the nreural drive and intrinsic positive end-expiratory
      pressure(PEEPi) of the chronic obstructive pulmonary disease(COPD) patients with respiratory
      failure.The diaphragm electromyogram (EMGdi) represents the neural drive to the diaphragm.A
      multi-pair esophageal electrode catheter was used to record the EMGdi.The PEEPi was assessed
      by the by the balloon-catheter in the multi-pair esophageal electrode catheter. In present
      study the PEEPi of COPD patients was increased by increasing the resistance of the
      respiratory system, the change of the neural drive( EMGdi) was obtained from the a multi-pair
      esophageal electrode catheter All the signal recorded in the computer. The relation the
      nreural drive assessed by EMGdi and intrinsic positive end-expiratory pressure(PEEPi) would
      be analysed.
    

Intervention name(s): Resistance of the respiratory system
Intervention type(s): Other
Intervention description(s): increase the resistance of the respiratory system of the chronic obstructive pulmonary disease patients
Intervention MeSH terms: Respiratory System Agents
Intervention model: Single Group Assignment
Intervention model description: the chronic obstructive pulmonary disease patients with respiratory failure
Masking: None (Open Label)
Primary purpose: Other
Keywords: neural respiratory drive; Intrinsic Positive End-expiratory Pressure; Chronic Obstructive Pulmonary Disease Patients
Study Comparing Pharmacokinetics, Safety and Immunogenicity of CT-P6 and US-licensed Herceptin
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a double-blind, two-arm, parallel-group, single-dose study.
    

Detailed description: 
      This is a double-blind, two-arm, parallel-group, single-dose study. A total of 70 healthy
      male subjects will be enrolled.
    

Intervention name(s): Trastuzumab
Intervention type(s): Drug
Intervention description(s): Each patient may receive single dose by intravenous infusion
Intervention MeSH terms: Trastuzumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Effects of Videolaryngoscope on Intraocular Pressure
Condition: Intubation Complication
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is designed to compare the effects of the McGrath Series 5 video laryngoscope and
      Macintosh laryngoscope on intraocular pressure during laryngoscopy.
    

Detailed description: 
      The stability of the intraocular pressure plays an important role during ophthalmic surgery.
      The systemic blood pressure, aqueous humor dynamics, choroidal blood volume, central venous
      pressure, extra-ocular muscle tone, and also conventional laryngoscopy affect the intraocular
      pressure.It was shown that the new devices for laryngoscopy, such as video laryngoscopes
      provide minimal hemodynamic changes when compared to direct laryngoscopes. However there is
      no current data about the effects of the intubation with McGrath videolaryngoscope on
      intraocular pressure. The main objective of this study to compare the effects of the McGrath
      Series 5 video laryngoscope and Macintosh laryngoscope on intraocular pressure during
      laryngoscopy.
    

Intervention name(s): Mcgrath; Macintosh
Intervention type(s): Device; Device
Intervention description(s): The patient will be intubated using McGrath series 5 video laryngoscope and the intraocular pressure of the patient will be evaluated with Tonopen XL tonometer; The patient will be intubated using Macintosh laryngoscope and the intraocular pressure of the patient will be evaluated with Tonopen XL tonometer
Other intervention name(s): videolaryngoscope; Conventional Laryngoscope
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Screening
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Middle East
Condition: Growth Disorders
MeSH terms: Growth Disorders
Study type: Observational

Summary: 
      This is a Middle East, Multicenter, Observational Study to evaluate Adherence and Long Term
      Outcomes of Therapy in pediatric subjects using easypod™ electromechanical device for growth
      hormone treatment and to assess the level of adherence of subject receiving SAIZEN® via
      easypod™.
    

Detailed description: 
      Subjects will be enrolled in a multicenter longitudinal observational study. Parents/subjects
      will provide their Informed Consent/assent to upload their data for population-based analyses
      and, ultimately, clinical outcomes. Adherence data will be primarily derived from the
      easypod™ device combined with physician data entry of outcome measures. Data will be
      collected both retrospectively and prospectively. This will allow the establishment of
      adherence profiles and explore the hypothesis that patient adherence support programs improve
      adherence and subsequent clinical outcomes. Collected data will be also analyzed in a
      multinational pooled analysis of comparable national studies.

      Primary Objective:

      • To assess the level of adherence of subjects receiving SAIZEN® via easypod™

      Secondary Objectives:

        -  To describe the impact of adherence on clinical outcomes for subject receiving SAIZEN®
           via easypod™

        -  To identify adherence subject profiling

        -  To assess the impact of adherence on Insulin-like Growth Factor 1 (IGF1) (that is,
           above, below or within normal ranges)
    

Intervention name(s): easypod™
Intervention type(s): Device
Intervention description(s): Saizen® (Somatropin) as per Summary of Product Characteristics administered by easypod™
Other intervention name(s): Somatropin
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Pediatric subjects (aged 2-18) who are taking SAIZEN® for registered indications using the
        easypod™ electromechanical device.
      
Keywords: Growth disorders; Saizen; Easypod; Growth hormone; Pediatric subject
The Optimization of Blood Pressure and Fluid Status Control With Eight-Polar Bioelectrical Impedance Analysis
Condition: Hypertension; Fluid Overload; Heart Diseases
MeSH terms: Heart Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      Peritoneal dialysis (PD) is a widely used modality of renal replacement therapy. Due to its
      continuous nature of therapy, better control of fluid status and preservation of residual
      renal function were presumed by most nephrologists. However, recent evidences showed that it
      might not be the case. The severity of fluid overloading and the need for anti-hypertensive
      agents to control blood pressure seems to be more severe for PD patients. Therefore, more
      aggressive strategy to control dry weight is mandatory in PD patients. However, over
      reduction of dry weight might affect residual renal function (RRF) and, probably, the
      survival of PD patients. A balance between reduction of dry weight and preservation of RRF is
      crucial for the care of PD patients. Currently, only clinical measures like cardiothoracic
      ratio on chest X-ray and absence of pedal edema were used to evaluate PD patient's dry
      weight. There is no objective method to determine dry weight accurately. In this prospective
      and randomized study, the investigators will use multi-frequency bio-impedance (MF-BIA) to
      detect intracellular and extracellular water (ECW) content of patients.
    


Intervention name(s): Bioelectrical impedance-guide dry weight reduction
Intervention type(s): Device
Intervention description(s): for optimal determination of fluid status, monthly BIA was performed to monitor fluid status and avoid dehydration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioimpedance; ultrafiltration; blood pressure; pulse pressure
PEEP During Induction of Anesthesia in Small Children
Condition: Pediatric Anesthesia
Study type: Interventional

Summary: 
      Positive end-expiratory pressure (PEEP) applied during induction of anesthesia prevents
      atelectasis formation and increases the duration of nonhypoxic apnea in obese and nonobese
      patients. PEEP also prevents atelectasis formation in pediatric patients. Because pediatric
      patients arterial desaturation during induction of anesthesia develops rapidly, we studied
      the clinical benefit of PEEP applied during anesthesia induction.
    


Intervention name(s): PEEP; ZEEP
Intervention type(s): Other; Other
Intervention description(s): 7cmH2O positive end expiratory pressure; 0 cmH2O positive end expiratory pressure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Learning and Decision-making
Condition: Motivation
Study type: Interventional

Summary: 
      A fundamental aspect of daily life decision-making involves the evaluation of costs and
      benefits. Neural systems underlying cost-benefit evaluation have been extensively examined,
      but the specific role of different neurotransmitters remains unclear. Numerous studies
      suggest that both dopamine (DA) and norepinephrine (NE) are closely related to reinforcement
      learning, guided exploration/exploitation, and behavioural energisation, although no studies
      to date have investigated the distinct role of DA and NE on cost-benefit decision-making and
      learning in human subjects.
    


Intervention name(s): placebo; haloperidol 2mg; propranolol 40mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral formulation; oral formulation; oral formulation
Intervention MeSH terms: Propranolol; Haloperidol; Haloperidol decanoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Pharmacokinetic Study of Buparlisib in Subjects With Renal Impairment.
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      To characterize the pharmacokinetics and safety of buparlisib following a single 50 mg oral
      dose in subjects with moderate and severe renal impairment.
    


Intervention name(s): Buparlisib
Intervention type(s): Drug
Intervention description(s): Subjects will receive a single dose of 50 mg buparlisib.
Other intervention name(s): BKM120
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Renal impairment; Healthy volunteers; Clinical pharmacology study
A Prospective, Open, Multicenter Clinical Trial of Eltrombopag Combined With Diacerein in Eltrombopag-inefficient or Relapsed ITP
Condition: Thrombocytopenia
MeSH terms: Thrombocytopenia
Study type: Interventional
Phase: Phase 2

Summary: 
      Eltrombopag is an oral thrombopoietin receptor agonist that has been licensed for use as
      second line therapy in ITP patients. Diacerein is a slow-acting medicine of the class
      anthraquinone used to treat joint diseases such as osteoarthritis. The project was
      undertaking by Qilu Hospital of Shandong University and other 5 well-known hospitals in
      China. In order to report the efficacy and safety of eltrombopag combined with diacerein in
      the management of ITP.
    

Detailed description: 
      The investigators are undertaking a prospective, open, multicentre trial of 30 ITP adult
      patients with eltrombopag-inefficient or relapsed from 6 medical centers in China. The
      initial dose of eltrombopag administration is 25 mg orally once daily, which could be
      transited to 50 mg/d in a 2-week cycle according to the need, and the maximum dose was not
      more than 75 mg/d. The dose of diacerein administration is 50 mg orally twice daily. The
      treatment was discontinued after 6 weeks without blood index reaction.

      Platelet count, bleeding and other symptoms were evaluated before and after treatment.
      Adverse events are also recorded throughout the study. In order to report the efficacy and
      safety of eltrombopag combined with diacerein for the treatment of adults patients with
      eltrombopag-inefficient or relapsed.
    

Intervention name(s): Eltrombopag and Diacerein
Intervention type(s): Drug
Intervention description(s): The initial dose of eltrombopag administration is 25 mg orally once daily, which could be transited to 50 mg/d in a 2-week cycle according to the need, and the maximum dose was not more than 75 mg/d. The dose of diacerein administration is 50 mg orally twice daily. The treatment was discontinued after 6 weeks without blood index reaction.
Other intervention name(s): diacetylrhein
Intervention MeSH terms: Diacerein
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ITP; Eltrombopag; Diacerein
The Clinical Study of the Safety and Efficacy of Istaroxime in Treatment of Acute Decompensated Heart Failure
Condition: Acute Decompensated Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the safety, tolerability and efficacy of two different doses of istaroxime, a new
      agent with lusitropic and inotropic activities that improves the cardiac
      contraction-relaxation cycle. The 2 doses of istaroxime (0.5 and 1.0 µg/kg/min) will be
      infused via i. v. for 24 hours in comparison with placebo, in treatment of Chinese and
      Italian patients with Acute Decompensated Heart Failure.
    

Detailed description: 
      To assess the safety, tolerability and efficacy of two different doses of istaroxime (0.5 and
      1.0 µg/kg/min) in comparison with placebo, including cardiovascular and renal tolerability,
      as well as changes in biological markers such as N-terminal prohormone brain natriuretic
      peptide (NT-proBNP) and troponin T (cTnT). The study will be conducted in 96 Chinese and
      Italian patients with Acute Decompensated Heart Failure. This is a phase II, multicenter,
      randomized, double-blind, placebo-controlled, parallel group study. Patients were randomly
      assigned to one of two doses of istaroxime or placebo in a 2:1 ratio within two sequential
      cohorts of 60 patients each. This 31-day study includes a screening period (Days -1), a
      treatment period (Day 1), a post-treatment period (Days 2-4), and a follow-up period (which
      includes one patient visit on Day 30).

      In all the Italian patients and in a subset of Chinese patients pharmacokinetics and
      metabolism of istaroxime shall also be studied.
    

Intervention name(s): Placebo; Istaroxime
Intervention type(s): Drug; Drug
Intervention description(s): IV of matching saline solution; IV infusion of 0.5 µg/kg/min or 1.0 µg/kg/min istaroxime
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Cohort I: Participants enrolled in a 2:1 ratio to istaroxime 0.5 µg/kg/min or placebo.
Cohort II: Participants enrolled in a 2:1 ratio to istaroxime 1.0 µg/kg/min or placebo.
Cohort I was enrolled first, followed by Cohort II.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: safety; efficacy; istaroxime
Lumbar Spine Manipulation Versus Pharmacological Therapy in Young Women With Primary Dysmenorrhea
Condition: Women With Primary Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Interventional

Summary: 
      Many treatments like acupuncture, manipulative therapy and pharmacological therapy have been
      proposed to alleviate symptoms associated with dysmenorrhea. However, no study has previously
      compared lumbar spine manipulation to pharmacological therapy in the treatment of primary
      dysmenorrhea.
    


Intervention name(s): Lumbar spine manipulation; Hyoscine and Ibuprofen
Intervention type(s): Other; Drug
Intervention description(s): Lumbar spine manipulation; hyoscine (20 mg) and ibuprofen (400 mg) administered by oral via.
Intervention MeSH terms: Ibuprofen; Scopolamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Role of Metabolites in Nicotine Dependence (3) - 6
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the effects of various doses of ondansetron
      transdermal nicotine replacement on tobacco withdrawal symptoms.
    

Detailed description: 
      Previous studies have shown that cotinine, a metabolite of nicotine, antagonizes the
      beneficial effects of the nicotine patch in redugin withdrawal symptoms. Studies have also
      shown that cotinine enhances serotonin levels. This study examined the effects of several
      doses of a 5HT3 antagonist, ondanstron, in combination with the nicotine patch. This
      medication has been observed to reduce nicotine withdrawal symptoms in rats. These effects
      were compared to the nicotine patch alone. The results of this study produced some modest
      effects showing that the 8mg dose of ondansetron suppressed tobacco withdrawal symptoms to a
      greater extent than the nicotine patch alone.
    

Intervention name(s): Ondansetron
Intervention type(s): Drug
Intervention MeSH terms: Ondansetron
Masking: Double
Primary purpose: Treatment
Real-World Outcome of Psoriasis Subjects in Korea on Adalimumab
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Observational

Summary: 
      The objective of this non-interventional, observational study is to assess the effect of
      adalimumab on health-related quality of life in participants with Psoriasis in Korea.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Participants with Psoriasis receiving adalimumab in Korea.
      
Keywords: Psoriasis; Adalimumab; Humira; Korea
Psychotherapy Outcome and Self-selection Effects in Panic Disorder
Condition: Panic Disorder (With or Without Agoraphobia)
MeSH terms: Panic Disorder; Agoraphobia
Study type: Interventional

Summary: 
      The efficacy of two forms of psychotherapy with panic disordered patients, a
      cognitive-behavioral and a psychodynamic one, are compared under two different, randomized
      conditions: randomization or self-selection. The basic hypotheses are that the efficacy of
      both treatments is higher and that the efficacy difference is smaller under self-selection
      than randomized conditions.
    

Detailed description: 
      After thorough assessment persons with a panic disorder diagnosis are randomly assigned to
      three arms: one randomization, one self-selection, and one a low-contact waiting list one. In
      the randomization arm (R) 95 persons are randomly assigned to Panic Control Treatment (PCT)
      or Panic-Focused Psychodynamic Psychotherapy (PFPP); in the self-selection arm (SS) 95
      persons are offered, after adequate information, to choose which of the two they prefer.
      Twenty-six persons are initially randomized to a three-month waiting list (with sparse
      contact over telephone), after which they will be re-randomized, either to further
      randomization (to PCT or PFPP) or to self-selection. The four groups (R/PCT; R/PFPP; SS/PCT;
      SS/PFPP) will be compared on the basis of intake and repeated outcome/follow-up assessment.
    

Intervention name(s): Panic Control Treatment (PCT); Panic-Focused Psychodynamic Psychotherapy (PFPP); Waiting-list
Intervention type(s): Behavioral; Behavioral; Other
Intervention description(s): Manualized, 13 sessions (60 min, sometimes extended to 90-120) completed in 12-16 weeks. Total duration 840-1080 min.; Manualized, 19-24 sessions (45 min) completed in 12-16 weeks. Total duration 855-1080 min.; Sparse telephone contact during 12 weeks, then re-randomization
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Influence of PRN Dry Eye Omega-3 Nutritional Regimen on Tear Osmolarity In Cases Of Dry Eye Disease
Condition: Dry Eye Disease
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The investigators hypothesize that oral omega-3-acid triglyceride form will decrease dry-eye
      related symptoms as well as clinical markers associated with dry eye disease (TearOsmolarity,
      Schirmer-1 test values, corneal staining, and fluorescein tear break-up time) when compared
      to administration of placebo.
    


Intervention name(s): Omega-3 (Triglyceride form)
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care