bioihbjkbjnl/mcl2 huggingface dataset:
Pilot Study of Atomoxetine To Enhance COgnition In Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      Relationships between altered prefrontal cortical dopamine, norepinephrine and some cognitive
      impairments of schizophrenia supports and approach for pharmacological remediation of
      cognitive symptoms through manipulations of prefrontal cortical dopamine and norepinephrine.
      Atomoxetine, a selective norepinephrine re-uptake inhibitor, produces a widespread increase
      in brain norepinephrine and a secondary and selective increase in prefrontal dopamine. Given
      this, we are evaluating atomoxetine's cognitive effects in a pilot placebo controlled trial
      in patients with schizophrenia. Moreover, an fMRI investigation was undertaken to assess the
      neural mechanisms underlying the cognitive effects of atomoxetine.
    

Detailed description: 
      Participants carrying a diagnosis of schizophrenia and receiving treatment with one of the
      following antipsychotic medications are eleigible for participation: risperidone, olanzapine,
      quetiapine, aripirazole. Following consent, participants will be observed for 4 weeks to
      ensure stability of their symptoms. Following this, there will be baseline assessments of
      symptom severity, cognitive ability, functional ability and an fMRI scan. Following this,
      participants will be randomly assigned to receive treatment with 40 mg of atomoxetine or
      placebo daily during a double-blind parallel designed four week treatment period, following
      which the dose of atomoxetine will be increased to 40 mg twice day (or matching placebo) for
      an additional 4 weeks. The cognitive assessment battery and MRI will be repeated following 8
      weeks of treatment.
    

Intervention name(s): Atomoxetine
Intervention type(s): Drug
Intervention description(s): Dose escalation from 40 mg to 50 mg of Atomoxetine active treatment.
Other intervention name(s): Strattera®
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: schizophrenia; cognition; atomoxetine; norepinephrine; dopamine
Subcutaneous NTG for US Radial Artery Cannulation
Condition: Morbid Obesity
MeSH terms: Obesity, Morbid
Study type: Interventional

Summary: 
      Clinicians are increasingly dealing with morbid obese patients. In morbid obese patients,
      difficult sampling and problems encountered with noninvasive blood pressure monitoring makes
      arterial cannulation an essential skill in many situations like surgeries or trans-radial
      procedures for coronary or carotid interventions.

      Radial artery has been preferred over other sites for arterial cannulation due to low
      incidence of bleeding, better hemostats, more comfort, and immediate ambulation. sm In this
      study, subcutaneous nitroglycerin will be used to facilitate radial artery cannulation aiming
      to decrease insertion time, increase success rate and decrease related complications
    


Intervention name(s): Subcutaneous nitroglycrin; Subcutaneous saline
Intervention type(s): Drug; Drug
Intervention description(s): In both groups, a 1 ml filled insulin syringe is delivered to a blinded operator who infiltrated it subcutaneously over 1 cm along the radial artery course. In the NTG group, the syringe contains 200 µg of NTG while in control group the syringe is filled with saline; In both groups, a 1 ml filled insulin syringe is delivered to a blinded operator who infiltrated it subcutaneously over 1 cm along the radial artery course. In the NTG group, the syringe contains 200 µg of NTG while in control group the syringe is filled with saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
First In Human Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04427429 Administered Intravenously To Healthy Adult Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and
      pharmacodynamics of PF-04427429 administered intravenously to healthy adult volunteers.
    

Detailed description: 
      Phase 1 clinical trial
    

Intervention name(s): PF-04427429; PF-04427429; PF-04427429
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single 0.2mg dose of intravenous infusion; Single 1mg dose of intravenous infusion; Single 3 mg dose of intravenous infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Ibuprofen Versus Placebo For Muscle Soreness
Condition: Muscle Soreness
MeSH terms: Myalgia
Study type: Interventional
Phase: Phase 4

Summary: 
      The study will assess the sensitivity of the Delayed Onset Muscle Soreness Model by comparing
      the safety and efficacy of oral ibuprofen to placebo over 24 hours.
    

Detailed description: 
      This is a double-blind, randomized, placebo controlled, parallel group, pilot safety and
      efficacy study. Healthy male or female subjects who have a history of occasional muscle
      soreness and are not currently exercising will be asked to volunteer for the study. All
      subjects will complete an informed consent process prior to study procedures.

      The study duration is anticipated to be approximately 4 months. Each subject may be in the
      study for up to 45 days including screening, run-in, inpatient and outpatient dosing and
      assessments, follow-up visit and follow-up telephone contact.
    

Intervention name(s): Ibuprofen 400 mg; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Subjects will receive 4 doses of oral ibuprofen over a 24 hour period.; Subjects will receive 4 doses of placebo over a 24 hour period.
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Tracheostomy Change
Condition: Tracheostomy
Study type: Interventional

Summary: 
      The purpose of this study is to compare outcomes of first tracheostomy change on
      postoperative day 4 to our current standard of care of first tracheostomy change on
      postoperative day 7.
    

Detailed description: 
      A "fresh tracheostomy" is a tracheostomy whose tract is not yet well formed and that has not
      yet been changed since the operative procedure. It is considered a "critical airway" since
      replacement following dislodgement may be difficult and at risk of forming a false tract.
      Thus, an infant or a child with a fresh tracheostomy is cared for in the intensive care unit
      and kept sedated to prevent accidental dislodgement. During this time wound care is often
      suboptimal due to fear of manipulating the neck. Patients are at increased risk of
      complications such as pressure ulcers and pneumonia related to being sedated for an extended
      length of time. Furthermore, prolonged sedation can lead to difficulties with withdrawal and
      delay recovery. Progression of the patient's care and the teaching of tracheostomy care to
      caregivers is also delayed. Thus, timing of the first tracheostomy change has great
      implications for prevention of complications as well as length of hospital stay. While in
      adults is it accepted that the first trach change can be done as early as post-operative day
      3. In pediatrics no good evidence or clear guidelines is available as to when the first
      tracheostomy change should occur. It is common to wait until days 5-7 which allows
      establishment of a mature tract however, there is no biologic reason to think that a
      pediatric tracheostomy tract should take any longer to epithelize than in an adult. Several
      studies have reported safe tracheostomy change in pediatric patients as early as
      postoperative day 3 (Deutsch 1998, Lippert 2014, Van Buran 2014). Currently at CHOP our
      standard of care is to perform the first tracheostomy change on post-operative day 7. The
      investigators aim to compare tracheostomy tube change at post-operative day 4 by randomizing
      patients undergoing tracheostomy at CHOP to day 4 (treatment) or day 7 (control) groups.
    

Intervention name(s): Early Tracheostomy Change
Intervention type(s): Procedure
Intervention description(s): The treatment group will have the first tracheostomy change on postoperative day 4 by an Otolaryngology physician (attending or fellow) on the study team.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Pharmacokinetic Interaction Between Micronized Fenofibrate and Pitavastatin
Condition: Healthy Male Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate pharmacokinetic drug interaction by comparing the steady-state pharmacokinetic
      characteristics of each arms after repeated administrating Lipilfen cap. 160mg and Livalo
      tab. 2mg through 3 period by separately or combinedly.
    

Detailed description: 
      To develop combination product of micronized fenofibrate plus pitavastatin, we would like to
      evaluate pharmacokinetic drug interaction by comparing the steady-state pharmacokinetic
      characteristics of each arms after repeated administrating Lipilfen cap. 160mg(micronized
      fenofibrate 160mg)by Dae Woong Pharma. and Livaro tab. 2mg (pitavastatin Ca 2mg) by Joong Wae
      Pharm. through 3 period by separately or combinedly.
    

Intervention name(s): micronized fenofibrate 160mg; pitavastatin Ca 2mg; micronized fenofibrate 160mg plus pitavastatin Ca 2mg
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Lipilfen cap. 160mg : once daily for 5 days; Livalo tab. 2mg : once daily for 5 days; Lipilfen cap. 160mg plus Livalo tab. 2mg : once daily for 5 days
Intervention MeSH terms: Infliximab; Fenofibrate; Pitavastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effect of Different Physical Programs on the Body Composition of Adult Men and Women With an Initial Body Fat >25% and >30%, Respectively.
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Compare the Effect of Different Physical Programs on the Body Composition of Adult Women and
      Men With a Total Body Fat Percentage ≥ 30 % at the Beginning of the Test or BMI ≥25
    

Detailed description: 
      Weight loss by exercise can be frequently deceptive. The focus continues to be centred around
      total body weight and body mass index (BMI), despite the fact that body fat and fat-free mass
      are the indicators that represent the greatest risk in the comorbidity associated with
      obesity. Body weight per se cannot be considered to be reliable; however, its quality can be
      justified, when measured together with the loss in body fat and the maintenance or increase
      in fat-free mass.

      The purpose of the study is compare the effect of different physical programs (FA) on the
      body composition (BC) of adult women with a total body fat percentage ≥ 30 % and adult men
      with a BMI ≥25 at the beginning of the test.

      Participants (n=220, women = 110, men = 110) will be recruited through outpatient from
      private clinics in Cádiz, Andalucía, Spain, as well as through community presentations.
      Overweight or obese and sedentary women and men will be randomly assigned into three groups
      according to different levels of AF. 21 of the participants will be assigned to the sedentary
      control group (METs <2.9), 20 in a group of moderate AF (METs 3-5.9), and 19 will be assigned
      to the group of intense AF (METs >6).

      For 6 months, all of the women shall follow the same diet with an identical distribution of
      macronutrients. There will be a weekly check up of weight, fat, body water and muscle mass
      for all of them.
    

Intervention name(s): education and modifying diet; education, modifying diet and physical activity prescription
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The control group maintains a sedentary lifestyle and is only subjected to follow a hypocaloric diet; One group, in addition to fulfilling a hypocaloric diet identical to the control group, is subjected to prescribe moderate physical activity.
Other group, in addition to fulfilling a hypocaloric diet identical to the control and moderate group, is subjected to prescribe intense activity.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: obesity; Physical Activity; fat mass; fat free mass
Microenvironment of Adipose Tissue in Endocannabinoid System
Condition: Obesity
MeSH terms: Obesity
Study type: Observational

Summary: 
      The purpose of this study is examine the relationship between adipose tissue inflammation and
      activation of the endocannabinoid system before and after Roux-en-Y gastric bypass surgery.
      The investigators hypothesize that the metabolic improvements and weight loss are due to
      mechanisms that antagonize the endocannabinoid system.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects approved and scheduled for gastric bypass surgery
      
Biospecimen description: 
      Whole blood, adipose tissue, adipose tissue microdialysate
    
Keywords: obesity; gastric bypass surgery
Study Will Evaluate the Relative Bioavailability, Safety, and Tolerability of Single Doses of Nifurtimox 30 mg Tablets Exhibiting Different in Vitro Dissolution Characteristics, and to Evaluate the Relative Bioavailability of Nifurtimox 30 mg and 120 mg
Condition: Chagas Disease
MeSH terms: Chagas Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to assess the relative Bioavailability To assess the relative bioavailability of three
      formulations of nifurtimox 30 mg tablets exhibiting different in vitro dissolution profiles
      To assess the pharmacokinetics (PK) of nifurtimox To investigate the safety and tolerability
      of nifurtimox.
    

Detailed description: 
      Primary objective is to assess the relative bioavailability of three formulations of
      nifurtimox 30 mg tablets exhibiting different in vitro dissolution profiles (slow, medium,
      and fast, whereby "medium" represents the drug product currently used in clinical Phase 3
      studies) under fed conditions in adult male and female patients with Chagas' disease.

      A secondary objective of the study is to assess the relative bioavailability of nifurtimox
      after a single oral dose of 30 mg and 120 mg To assess the pharmacokinetics (PK) of
      nifurtimox To investigate the safety and tolerability of nifurtimox..
    

Intervention name(s): Nifurtimox (Lampit, BAYA2502)
Intervention type(s): Drug
Intervention description(s): Oral Intake of 4 x 30 mg nifurtimox tablets for treatment A-C; Oral Intake of 1 x 30 mg nifurtimox tablets for treatment D Oral intake of 1 x 120 mg nifurtimox tablet for treatment E
Intervention MeSH terms: Nifurtimox
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Group 1 ( Treatment A,B,C - 3 way cross-over), Group 2 ( Treatment D, E - 2 way cross over)
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Relative bioavailability; In vitro dissolution
A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder
Condition: Autistic Disorder
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to investigate the safety and efficacy of aripiprazole orally
      administered over long term in subjects who complete a short-term treatment study of
      pediatric Autistic Disorder (031-11-002 study).
    


Intervention name(s): Aripiprazole
Intervention type(s): Drug
Intervention description(s): Flexibly dose administered orally once daily
Intervention MeSH terms: Aripiprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Autistic Disorder, children and adolescents; aripiprazole; Long-term safety study; children and adolescents
Safety and Efficacy of Palonosetron in Preventing Chemotherapy-induced Nausea and Vomiting
Condition: Nausea; Vomiting; Chemotherapy
MeSH terms: Nausea; Vomiting
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether palonosetron is tolerate and effective in
      preventing chemotherapy-induced nausea and vomiting in oriental population. The study is
      comparing the safety and efficacy of palonosetron with granisetron, a frequently used
      antiemetic in China.
    


Intervention name(s): Palonosetron; Granisetron
Intervention type(s): Drug; Drug
Intervention MeSH terms: Palonosetron; Granisetron
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: chemotherapy-induced nausea and vomiting; acute; delayed; emesis; antiemetics; 5-HT3 receptor antagonist; granisetron; palonosetron
Ocular Hemodynamic Effects of Nitrovasodilators in Healthy Subjects
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional

Summary: 
      Glaucoma, one of the most common causes of blindness, is associated with increased
      intraocular pressure (IOP) and optic nerve head ischemia. Nitrovasodilators are discussed in
      the treatment of glaucoma. Nitrates relax smooth muscle cells in the vasculature by
      liberating the vasodilator nitric oxide.

      The IOP lowering potential and the vasodilator action in retinal and choroidal vessels of
      nitrates is still a matter of controversy. Previous studies on the ocular hemodynamic effects
      of nitrates showed partially contradicting results. In addition the IOP lowering effect of
      nitrates is still unclear. However, recent studies show that long acting nitrates may
      preserve optic nerve deterioration and visual field loss.

      Therefore, the role of nitrovasodilators in control of ocular blood flow and intraocular
      pressure has to be elucidated. For this purpose the investigators plan to test the hypothesis
      that nitrovasodilators improve ocular blood supply to the optic nerve head at doses which do
      not affect systemic hemodynamics.
    


Intervention name(s): Nitroglycerin; Isosorbide-Dinitrate; Sodium-nitroprusside; Physiologic saline solution (control substance)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): intravenous infusion; 0, 0.125, 0.25, 0.5, 1 and 2 µg/kg/min; 20 minutes per infusion step; intravenous infusion; 0, 0.5, 1, 2, 4, and 6 µg/kg/min; 20 minutes per infusion step; intravenous infusion; 0, 0.25, 0.5, 1, 2, and 4 µg/kg/min; 20 minutes per infusion step; intravenous infusion, infusion period 120 minutes
Intervention MeSH terms: Nitroprusside; Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate; Nitroglycerin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Nitrovasodilators; ONH blood flow; Choroidal blood flow; Nitroglycerin; Isosorbide Dinitrate; Sodium nitroprusside; Laser-Doppler Flowmetry; Regional Blood Flow
Multi-center Study to Transplant Hepatitis-C Infected Kidneys
Condition: Renal Failure Chronic; Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis; Renal Insufficiency; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      Open label multi center study for the donation of HCV positive kidneys to HCV negative
      recipients with interventional treatment to prevent HCV transmission upon transplantation.
    

Detailed description: 
      The study objective is to determine if the administration of the direct acting antiviral
      glecaprevir/pibrentasvir for 8 weeks after kidney transplantation is both safe and effective
      at preventing the spread of HCV infection from donor kidney with known HCV infection (all
      genotypes) to an HCV negative recipient as evidenced by a negative HCV viral RNA at 12 weeks
      post treatment.
    

Intervention name(s): glecaprevir/pibrentasvir treatment
Intervention type(s): Drug
Intervention description(s): combination treatment with glecaprevir and pibrentasvir fixed dose tablet.
Other intervention name(s): Mavyret treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: hemodialysis; renal failure; kidney transplant
Eye to Brain Connection
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Observational

Summary: 
      This is a non-randomized, non-treatment, observational study designed to discover
      correlations between retinal imaging and amyloid PET imaging. Subjects will be recruited to
      the clinical cohort from referring physicians. Subjects may be participants from existing
      studies and clinical practices
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Up to 100 adults between 50 and 90 years old, and undergoing evaluation for Alzheimer's
        Disease or other cognitive impairments will be recruited from the community. Patients will
        be asked if they would like to hear about a study related to better diagnostic tools for
        cognitive decline and dementias, which is seeking volunteers to undergo a non-invasive eye
        scan with a new type of camera. Informed consent will be obtained prior to enrollment in
        the study.
Description of Treatment Management of Patients With Major Depressive Disorder and Inadequate Response
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Observational

Summary: 
      The purpose is to assess the response of add-on therapy, based on CGI-I scale, at 4 weeks, in
      patients with MDD who had an inadequate disease control with antidepressant medication.
    

Detailed description: 
      A cross-sectional observational study to describe treatment management of patients with Major
      Depressive Disorder (MDD) and inadequate response to antidepressants in Greece
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Psychiatric patients
      
Keywords: antidepressant therapy, inadequate control, add-on therapy