bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Acute Bronchodilator Effect of CHF1535 NEXThaler
Condition: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study is to demonstrate the non-inferiority in terms of acute bronchodilator
      effect between a single dose of CHF 1535 NEXThaler 200/6 µg and a single dose of CHF 1535
      NEXThaler 100/6 µg at two dose levels in partially controlled and uncontrolled asthmatic
      patients.
    


Intervention name(s): Beclometasone Dipropionate 100 µg + Formoterol Fumarate 6 µg; Beclometasone Dipropionate 200 µg + Formoterol Fumarate 6 µg; Placebo
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Foster NEXThaler
Intervention MeSH terms: Beclomethasone; Formoterol Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Usage of LMA Protector on Patients Who Undergo Laparoscopic Surgery
Condition: Laryngeal Mask Airway
Study type: Interventional

Summary: 
      LMA Protector is a recently developed second generation laryngeal mask several kinds of
      different laryngeal masks were used for the airway management during laparoscopic surgeries.
      However there is a lack of knowledge for the use of LMA Protector during laparoscopic surgery
      .In this study researchers aim to determine the effectivity of LMA Protector and plan to
      analyse the orofaryngeal cuff pressure and fiberoptic grading scale measurements .
    

Detailed description: 
      Tracheal intubation may have more complications than laryngeal masks. In this study
      researchers aim to determine the effectivity of LMA Protector and on the otherside the
      heamodynamic variables and the complication rates between tracheal ıntubation and laryngeal
      mask insertion will be compared.
    

Intervention name(s): LMA Protector; Tracheal Intubation
Intervention type(s): Device; Device
Intervention description(s): LMA Protector will be inserted by a blind researcher after standart anesthesia induction. The view of the larynx will be assessed using fiberoptic grading scale; tracheal intubation will be perform after standart anaesthetic induction and heamodynamic variables including blood pressure heart rate and possible complications will be observed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: laryngel mask airway; laparoscopic surgery
Efficacy and Safety Study of SyB L-0501 for Patients With Chronic Lymphocytic Leukemia
Condition: Chronic Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate safety and efficacy of SyB L-0501 after 2-day
      intravenous infusion at a dose of 100 mg/m2/day to patients with chronic lymphocytic
      leukemia.
    


Intervention name(s): SyB L-0501
Intervention type(s): Drug
Intervention description(s): SyB L-0501 is administered at 100 mg/m2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Confirmatory Study for Evaluation of the Treatment by the Celluma3 of Periorbital Wrinkles
Condition: Wrinkled Structure
Study type: Observational

Summary: 
      The primary objective of this study is to confirm the safe and effective use of the Celluma3
      for the reduction in the appearance of periorbital wrinkles.
    

Detailed description: 
      This clinical study is an open label investigation into the use of the Celluma3 for the
      effective treatment of periorbital wrinkles.

      Test subjects will visit a study center for thirty minute treatments, three times per week,
      for a period of four weeks, and a twelve week post-treatment follow up after the final
      treatment. Test subjects will have photos taken at the start, at the end of the four week
      treatment, and at the final twelve week post-treatment follow up visit.

      One of the three Clinical Investigators, will act as the Principal Investigator and all three
      Clinical Investigators will evaluate the test subjects for inclusion and final results. The
      Clinical Research Associate (CRA) will monitor the study for conformance to the test
      protocol.

      There will be seven estheticians participating in the study and there will be fifty test
      subjects recruited.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Test subjects will be between the ages of 30-75, Type I-IV Fitzpatrick Skin Color, and
        willingness and ability to participate and comply with the test protocol and absence of
        exclusionary criteria.
Efficacy and Safety Study of HS-25 in Chinese Adults With Primary Hypercholesterolemia
Condition: Primary Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine the efficacy of HS-25 (20mg) in reducing low density lipoprotein-cholesterol
      (LDL-C) levels after a 12-week period of treatment in adults with primary
      hypercholesterolemia;

      To determine the safety of HS-25 (20mg) in subjects with LDL-C
    

Detailed description: 
      This is a 12-week, randomized, double-blind, placebo-controlled study designed to assess the
      effects of the cholesterol absorption inhibitor HS-25 on LDL-C levels in adults who have
      untreated LDL-C levels ranging from 3.36-4.88mmol/L(130-189 mg/dL)and fasting triglyceride
      levels < 350 mg/dL. Eligibility is restricted to 18-75 years old men or women who are using a
      highly effective birth control method or are not of childbearing potential. Patients with
      diabetes, a history of myocardial infarction or other clinical evidence of atherosclerotic
      vascular disease are not eligible for participation in the study.
    

Intervention name(s): HS-25; Placebo of HS-25
Intervention type(s): Drug; Drug
Intervention description(s): HS-25 10mg/tablet, 20mg,once daily,for 12 weeks, and then HS-25 20mg once daily for 40 weeks.; Placebo HS-25 10mg/tablet, 20mg,once daily,for 12 weeks,and then HS-25 20mg once daily for 40 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
a Single Intraarticular Injection of PRP for Early Knee OA
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      This study aimed to investigate the efficacy of a single intraarticular injection of PRP for
      the treatment of early knee OA.
    

Detailed description: 
      Platelet-rich plasma (PRP) has been reported to be effective for the treatment of knee
      osteoarthritis (OA). This study aimed to investigate the efficacy of a single intraarticular
      injection of PRP for the treatment of early knee OA.

      In a prospective trial with 6-month follow-up, patients with early knee OA were recruited and
      received a single intraarticular PRP injection. Several outcomes were measured.
    

Intervention name(s): PRP
Intervention type(s): Other
Intervention description(s): The patients received a single 3-ml injection of PRP. Approximately 10-mL of venous blood was drawn from each patient and centrifuged using an Arthrex autologous conditioned plasma (ACP) kit (a low-leukocyte ACP system), spun at a speed of 1500 rpm for 5 minutes. The platelet concentration obtained was approximately 2-3 times greater than the baseline platelet concentration.
Intervention model: Single Group Assignment
Intervention model description: Clinical trials with a single arm
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: knee; Osteoarthritis; Platelet rich plasma
Coronary Computed Tomographic Angiography for Selective Cardiac Catheterization
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional

Summary: 
      To determine the effectiveness, safety, and cost efficiency associated with a CCTA-guided
      selective catheterization strategy for stable patients but without known CAD and an American
      Heart Association/ American College of Cardiology Class II indication for non-emergent
      invasive coronary angiography.
    

Detailed description: 
      A prospective, randomized controlled multicenter trial to determine the clinical and cost
      effectiveness of a "selective catheterization" strategy versus a "direct catheterization"
      strategy for stable patients with suspected but without known CAD and clinical indication for
      non-emergent invasive coronary angiography. Subjects in the "selective catheterization" arm
      will be followed for a primary endpoint of non-inferiority for rates of major adverse cardiac
      events (MACE) as compare to subjects in the "direct catheterization" strategy.
    

Intervention name(s): Cardiac CT; Invasive Coronary Angiography
Intervention type(s): Procedure; Procedure
Intervention description(s): Perform a non-invasive Cardiac CT Angiogram; Patient undergoes Invasive Coronary Angiography
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Coronary Artery Disease; Cardiac CT; Catheterization
Comparing Gabapentin and Lorazepam for Treating Alcohol Withdrawal
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate a safe and useful medication for outpatient detoxification that is
      as effective as benzodiazepines in the short-term, and more effective in the protracted
      withdrawal period. Gabapentin (Neurontin) will be compared to a standard benzodiazepine,
      lorazepam (Ativan), for its effectiveness in treating alcohol withdrawal.
    


Intervention name(s): gabapentin (Neurontin); lorazepam (Ativan)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Gabapentin; Lorazepam
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
The Objective of This Study is to Evaluate the Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD) Who Have Had an Inadequate Response to Antidepressants Alone
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate the efficacy, safety and tolerability of
      cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with MDD
      who have had an inadequate response to antidepressants alone.
    


Intervention name(s): Cariprazine; Placebo; Antidepressant Therapy (ADT)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Cariprazine supplied in capsules; Placebo supplied in capsules; ADT as prescribed by the physician per standard of care in clinical practice.
Other intervention name(s): VRAYLAR®
Intervention MeSH terms: Cariprazine; Antidepressive Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: MDD
Viral Pathogenesis of Early Cystic Fibrosis Lung Disease
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Lung Diseases; Pulmonary Fibrosis; Fibrosis
Study type: Observational

Summary: 
      The purpose of this study is to test the hypothesis that early viral infections alter the
      bacterial flora and inflammatory profile in the airway and accelerate progression of
      pulmonary disease in infants with cystic fibrosis.
    

Detailed description: 
      The proposed study is a unique international collaboration between three large CF research
      centers. This proposal will determine the impact of early respiratory viral infections on
      bacterial flora and inflammatory profiles in the CF airway as well as the impact of these
      pathogens on clinical, physiologic and structural markers of disease.The proposed study is
      designed to follow infants diagnosed with CF through newborn screening to determine the
      effect of viral infections on the lower airway microbiome, clinical symptoms, pulmonary
      function and structural changes during the first year of life. The proposed study will
      measure lower airway inflammation and infection using BAL, oral swabs, and nasal swabs;
      outcomes will be assessed through infant lung function testing, computerized tomography scans
      of the chest, and pulmonary exacerbation rate.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Infants, less than 4 months of age who have been diagnosed with Cystic Fibrosis
      
Biospecimen description: 
      Blood Urea, Bronchopulmonary Lavage samples, Nasal swabs and Oral swabs, Stool samples
Evaluation of HIV-1, HCV and HBV Blood Screening Tests With Human Blood Donor Specimens
Condition: Screening for the Presence of HIV-1, RNA and HBV DNA in Blood Donations
Study type: Interventional

Summary: 
      The purpose of this study is to validate the performance characteristics of an assay that
      tests for HIV-1, HCV and HBV on an automated blood bank instrument for registration
      submission.
    


Intervention name(s): Blood test
Intervention type(s): Device
Intervention description(s): Screening of HIV-1 RNA, HCV RNA and HBV DNA in Human Blood Donor Plasma Specimens
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Nucleic acid test; HIV-1; hepatitis; HBV; HCV; TMA; HIV Seronegativity
Safety and Efficacy Study of RA101495 in Subjects With Generalized Myasthenia Gravis
Condition: Generalized Myasthenia Gravis
MeSH terms: Myasthenia Gravis; Muscle Weakness
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the safety and efficacy of RA101495 in patients with
      generalized Myasthenia Gravis (gMG). Subjects will be randomized in a 1:1:1 ratio to receive
      daily SC doses of 0.1 mg/kg RA101495, 0.3 mg/kg RA101495, or matching placebo for 12 weeks.
    


Intervention name(s): zilucoplan (RA101495); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Daily subcutaneous (SC) injection; Daily subcutaneous (SC) injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Phase I Pharmacokinetic and Tolerance Study of 28-Day Regimens of Oral Ganciclovir
Condition: Cytomegalovirus Retinitis; HIV Infections
MeSH terms: Infections; Cytomegalovirus Retinitis; Retinitis
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the pharmacokinetics (blood levels) of three dose treatment plans of oral
      ganciclovir during a 28-day dosing period. Other purposes of the study are to determine in a
      population of HIV seropositive persons with cytomegalovirus (CMV) viremia, the safety,
      tolerance, and patient acceptability of oral ganciclovir given for 28 days, to collect
      preliminary laboratory evidence for antiviral activity and effectiveness of three dose
      regimens of oral ganciclovir based on blood and urine cultures of CMV, and to relate
      antiviral activity to dosage and to serum ganciclovir levels.

      CMV retinitis is an important sight-threatening opportunistic infection which affects about
      10 to 15 percent of people with AIDS. A previous study has shown that treatment with
      ganciclovir resulted in a significant delay in time to first retinitis progression compared
      to untreated controls. More studies are warranted to evaluate effects at different doses.
    

Detailed description: 
      CMV retinitis is an important sight-threatening opportunistic infection which affects about
      10 to 15 percent of people with AIDS. A previous study has shown that treatment with
      ganciclovir resulted in a significant delay in time to first retinitis progression compared
      to untreated controls. More studies are warranted to evaluate effects at different doses.

      In group A, 36 HIV seropositive patients with CMV viruria receive a single dose of
      intravenous ganciclovir followed by one of three oral dose regimens for 28 days. Twelve
      individuals are treated at each dose level. In group B, 12 patients with AIDS and CMV
      retinitis receive oral ganciclovir therapy. These 12 patients must have received an induction
      course of intravenous ganciclovir for 4 weeks prior to study entry and must have stable CMV
      retinitis. Measurements for both groups include pharmacokinetics, safety, and tolerance
      (history, physical examination, hematology, and serum chemistry), and CMV blood and urine
      cultures. In addition, there are weekly ophthalmologic evaluations for individuals in the
      group B study.
    

Intervention name(s): Ganciclovir
Intervention type(s): Drug
Intervention MeSH terms: Ganciclovir; Ganciclovir triphosphate
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Retinitis; AIDS-Related Opportunistic Infections; Ganciclovir; Cytomegalovirus Infections; Acquired Immunodeficiency Syndrome
An Investigation of the Effects of Erythromycin on the Pharmacokinetics of the Pregabalin Controlled Release Tablet
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to 1) evaluate the extent of absorption of a single dose of a
      pregabalin controlled release tablet with and without coadministration of erythromycin and 2)
      evaluate the safety and tolerability of a single dose of a pregabalin controlled release
      tablet with and without coadministration of erythromycin.
    

Detailed description: 
      Evaluate the absorption, pharmacokinetics, safety/tolerability of a single dose of a
      pregabalin CR tablet with and without erythromycin
    

Intervention name(s): Pregabalin controlled release, 330 mg; Pregabalin controlled release, 330 mg; erythromycin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A single oral dose of 330 mg controlled release tablet; A single oral dose of 330 mg controlled release tablet; A total of three doses of 500 mg erythromycin ethylsuccinate tablets administered six hours apart beginning approximately 1 hour prior to pregabalin CR
Intervention MeSH terms: Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate; Pregabalin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: pregabalin; pharmacokinetics; bioavailability; bioequivalence
Study to Evaluate the Safety, Tolerability and Efficacy of Three Dose Levels of Mitoglitazone in Type 2 Diabetic Patients
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and efficacy of three dose
      levels of Mitoglitazone™ (MSDC-0160) in patients with type 2 diabetes.
    

Detailed description: 
      The primary study objectives are to characterize the reduction in fasting plasma glucose in
      response to three different doses of Mitoglitazone as compared to placebo following
      once-daily dosing for 84 consecutive days (12 weeks) in patients with Type 2 diabetes and to
      investigate the safety and tolerability of three different doses of Mitoglitazone following
      once-daily dosing for 84 consecutive days (12 weeks) in patients with Type 2 diabetes.
    

Intervention name(s): Mitoglitazone; Mitoglitazone; Mitoglitazone; Pioglitazone; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 50 mg capsules, once daily for 84 days; Mitoglitazone 100 mg capsules, once daily for 84 days; Mitoglitazone 150 mg capsules, once daily for 84 days; Pioglitazone 45 mg, once daily for 84 days; Placebo, once daily for 84 days
Other intervention name(s): MSDC-0160; MSDC-0160; MSDC-0160; ACTOS
Intervention MeSH terms: Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes
Combined Behavioral and Analgesic Trial for Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized control study that involves a combination of a drug treatment,
      behavioral health, and placebo controls.

      Some participants will receive a medication approved by the Food and Drug Administration for
      treatment of moderate to moderately severe pain called Tramadol HC1 IR. Others will receive
      an inactive pill, called a placebo. There will also be 2 different types of behavioral health
      treatments, Cognitive-Behavior Therapy (CBT) and Health Education (HE) both of which have
      been recommended for the treatment of patients with FM by the American Pain Society.

      There are 4 possible study treatment combinations:

        1. Tramadol + CBT,

        2. Tramadol + HE,

        3. Placebo + CBT,

        4. Placebo + HE.

      Although Tramadol, CBT, and HE have been shown to have some benefits for FM patients, there
      have been no studies that have evaluated the combination of medication and a behavioral
      health treatment. The primary purpose of this study is to compare the benefits of the 4
      combinations listed.
    


Intervention name(s): Tramadol; Placebo; Cognitive Behavior Therapy for FM; Health Education
Intervention type(s): Drug; Drug; Behavioral; Behavioral
Intervention description(s): 50 mg tablets titrated up to 2 tablets four times per day for a maximum dose of 400mg per day.
Minimum accepted dose of 200mg per day; Pharmacological inactive tablet, 50mg tablets titrated to 2 tabs per day up to 400mg; Subjects will be seen for 8 weekly 50 minute sessions of Cognitive Behavior Therapy that has been specifically tailored for Fibromyalgia patients.; Subjects will receive 8 weekly 50 minute sessions of Health Education on Fibromyalgia
Intervention MeSH terms: Tramadol
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment