bioihbjkbjnl/mcl2 huggingface dataset:
Study Comparing the Tolerability of Seroquel IR With Seroquel XR in Patients With Bipolar Depression
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to compare the sedation profile one hour after dose
      administration between Seroquel IR and Seroquel XR.
    


Intervention name(s): Quetiapine Immediate Release; Quetiapine Extended Release
Intervention type(s): Drug; Drug
Intervention description(s): Oral, 3 tablets daily: (2 x 25 mg + 1 x 50 mg) at one time each day; Oral, 3 tablets daily: (2 x 25 mg + 1 x 50 mg) at one time each day
Other intervention name(s): Seroquel IR; Seroquel XR
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: inpatient; bipolar depression; quetiapine; Seroquel IR; Seroquel XR; safety; tolerability
Assessing the Efficacy of Four Drug Combinations as the Next First-line Therapy for Uncomplicated Malaria in Malawi
Condition: Malaria, Falciparum
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 4

Summary: 
      Sulfadoxine-pyrimethamine (SP) is the current first-line treatment for uncomplicated malaria
      in Malawi. The malaria parasite P. falciparum has developed resistance to this drug so that
      the drug is much less effective than in previous years. This study was developed and
      conducted in collaboration with the National Malaria Control Programme of Malawi to assess
      the efficacy of four antimalarial drug combinations to provide evidence to assist the
      Malawian Ministry of Health in identifying and implementing as policy the next first-line
      antimalarial for uncomplicated malaria in Malawi. In an open, randomized trial in children
      under five years of age, four drug combinations, all of which are licensed in Malawi, are
      being assessed: amodiaquine plus sulfadoxine-pyrimethamine (AQ-SP), amodiaquine plus
      artesunate (AQ-Art), chlorproguanil-dapsone plus artesunate (CD-Art) and
      lumefantrine-artemether (LA). SP is also included as a fifth arm of the study for current
      data on its efficacy. Data on side effects of the drugs will also be collected. The results
      of this study will provide some of the information necessary to guide the Malawi National
      Malaria Control Program in selecting its next first antimalarial treatment for uncomplicated
      malaria. The study adheres to the World Health Organization's 2003 standardized protocol for
      assessing antimalarial drug efficacy.
    


Intervention name(s): sulfadoxine-pyrimethamine; amodiaquine plus sulfadoxine-pyrimethamine; amodiaquine plus artesunate; chlorproguanil-dapsone plus artesunate; lumefantrine-artemether
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Artesunate; Lumefantrine; Pyrimethamine; Artemether; Sulfadoxine; Fanasil, pyrimethamine drug combination; Amodiaquine; Dapsone; Chlorproguanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: antimalarials
Effect of Oral Zinc and Vitamin E Supplementation on Short-term Postoperative Outcomes in Cardiac Surgery Patients.
Condition: Heart Surgery
Study type: Interventional

Summary: 
      Cardiac surgery can cause oxidative stress due to ischemia-reperfusion. Using antioxidants
      during perioperative period may help improve this condition. Vitamin E and zinc have
      antioxidant effects. In this study, the effects of oral co-administration of zinc and vitamin
      E supplements on short-term postoperative outcomes in cardiac surgery patients will be
      investigated.
    

Detailed description: 
      Cardiac surgery is a life-saving invasive procedure that may often be associated with
      significant postoperative complications. Cardiac surgery can cause oxidative stress due to
      ischemia-reperfusion. This is a post-ischemic complication that occurs when blood circulation
      is restored and causes inflammation and oxidative damage. Cardiac surgery with reperfusion
      injury can adversely affect the prognosis. Thus, reducing the extend of reperfusion injury
      and its associated pathways can be considered an important clinical issue. Reducing oxidative
      stress and inflammation may play an important role in the outcomes of heart surgery. Using
      antioxidants in pre or post surgery may help improve this condition. Vitamin E is a
      well-known fat-soluble antioxidant that prevents lipid peroxidation. Zinc has several roles
      including antioxidant effects. Zinc acts as a cofactor for important enzymes that contribute
      to the proper functioning of the antioxidant defense system. In addition, the mineral is
      involved in reducing free radicals by inducing metallothionein synthesis and circulating zinc
      concentration decreases significantly after surgery. In this study, the effects of oral
      co-administration of zinc and vitamin E supplements shortly before and after surgery on
      short-term postoperative outcomes, plasma concentrations of biomarkers of oxidative stress
      and inflammation in patients will be investigated.
    

Intervention name(s): Oral zinc + vitamin E; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): In the zinc + vitamin E supplementation group, patients will receive a cumulative dose of 120 mg of oral zinc supplementation plus a cumulative dose of 1200 IU of oral vitamin E before surgery. After surgery, from the second day to the end of the hospital stay, patients receive 30 mg of zinc supplement plus 200 units of vitamin E per day.; Patients in the placebo group will receive placebo pills before and after surgery.
Intervention MeSH terms: Vitamin E
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Identifying Biomarkers That Distinguish PTSD and mTBI Using Advanced Magnetic Resonance Spectroscopy
Condition: Post-Traumatic Stress Disorders; Brain Injuries
MeSH terms: Brain Injuries; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Observational

Summary: 
      The purpose of this study is to develop a new test to help diagnose mild traumatic brain
      injury (mTBI) and post-traumatic stress disorder (PTSD) in soldiers. Chemicals in the brain
      will be measured using a Magnetic Resonance Spectroscopy (MRS) scan. In the study, the
      investigators will compare the information they obtain from scans of participants with mTBI,
      PTSD or both, to scans from healthy volunteers to understand the differences between these
      groups. If the results can tell the difference between participants with mTBI and PTSD, the
      investigators should be able to help safely diagnose patients in the future.
    

Detailed description: 
      Soldiers from the US Army, with well characterized diagnosis of mTBI or PTSD, will be
      recruited in the first year as will age-matched healthy controls from the military and
      civilian populations. MRI, single voxel MRS, and two-dimensional correlated spectroscopy (2D
      COSY) MRS will be acquired from each participant at the Brigham and Women's Hospital (BWH).
      This data will be anonymized and transferred to the Draper Laboratories. Biomarkers for each
      disease will be identified by comparison with control data. These biomarkers will then be fed
      into classifiers that will then be validated with a similar cohort acquired in the second
      year. The second cohort of subjects will then be incorporated into the classifier algorithms
      for a stronger and more robust classification from which a diagnostic test will emerge. To
      test this diagnostic evaluation the data analysis by both BWH and Draper labs will be blinded
      to the characterization of the participants and from the MRS results, the investigators will
      predict if the participant has mTBI, PTSD, both, or neither. Finally, all data will then be
      fused into the algorithms to provide a final classifier. The results of the final classifier
      will then be correlated with clinical, neuropsychological, and neuroanatomical indices of
      mTBI and PTSD. These correlations will provide the most complete biochemical analysis of mTBI
      and PTSD which may lead to insight into alternate pathways for drug development.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A total of 330 men and women from the Massachusetts National Guard, Active Duty Army, and
        veterans in the New England area and Brigham and Women's Hospital, Boston as well as
        healthy military and civilians will take part in this study.
      
Keywords: PTSD, mTBI
Quantitative Analysis of Functional CT Imaging of Coronary Atherosclerosis
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Atherosclerosis
Study type: Observational

Summary: 
      The purpose of this prospective observational study is to evaluate the diagnostic and
      prognostic performance of a "one-stop" comprehensive coronary artery anatomy and function
      assessment for CAD.
    

Detailed description: 
      Coronary CT angiography (CCTA) has become a reliable diagnostic technique to evaluate
      coronary artery disease (CAD) with high sensitivity and a negative predictive value. However,
      CCTA provides only anatomic information and tends to overestimate stenosis severity and is
      limited in its ability to diagnose myocardial ischemia. Undertaking additional CT myocardial
      perfusion imaging(CT-MPI) and CT-FFR improves specificity and positive predictive value,
      reducing unnecessary invasive coronary angiography. The purpose of this prospective
      observational study is to evaluate the diagnostic and prognostic performance of a "one-stop"
      comprehensive coronary artery anatomy and function assessment for CAD. SPECT myocardial
      perfusion imaging (SPECT-MPI)and invasively measured fractional flow reserve (FFR) will serve
      as the reference standard.
    

Intervention name(s): CCTA, CT-MPI, CT-FFR, SPECT-MPI
Intervention type(s): Diagnostic Test
Intervention description(s): Subjects undergo CCTA, CT-MPI, CT-FFR or SPECT-MPI
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with known or suspected CAD
      
Keywords: CT myocardial perfusion imaging; SPECT myocardial perfusion imaging
Traumacel PULVIS and Traumacel ENDO Applicator in the Post-market Surveillance Phase
Condition: Bleeding; Surgical Wound
MeSH terms: Surgical Wound
Study type: Interventional

Summary: 
      Traumacel PULVIS is a sterile absorbable haemostatic plant polysaccharide powder made of the
      oxidized cellulose. Traumacel PULVIS is designed to stop capillary bleeding as well as to
      prevent bleeding in the early post-operative stage, for example to stop capillary bleeding
      from resection areas of parenchymatous organs, muscles, to stop bleeding after endoscopy,
      mainly rectoscopic, procedures. The broadness of application allows for use in procedures
      performed in the standard way as well as endoscopically.

      Traumacel ENDO Applicator is a single use, flexible, manual apparatus designed to deliver the
      absorbable haemostatic powder Traumacel PULVIS.

      The main objective of this clinical study is to confirm the safety and efficacy of the
      medical device Traumacel PULVIS and Traumacel ENDO Applicator when used in accordance with
      their intended purpose.

      The partial objectives are: to identify potential incompatibilities of Traumacel ENDO
      Applicator with other surgical instruments, in particular with different types of trocar
      cannulas; for both devices (Traumacel ENDO Applicator and Traumacel PULVIS) the
      identification and analysis of potential emerging risks; confirmation of the acceptability of
      the benefit-risk ratio; identification of any systematic misuse of the device or off-label
      use of the device in order to verify the correctness of its intended purpose.
    


Intervention name(s): Traumacel PULVIS, Traumacel ENDO Applicator
Intervention type(s): Device
Intervention description(s): Haemostatic plant polysaccharide powder made of the oxidized cellulose with flexible applicator (38 cm).
Other intervention name(s): Traumastem POWDER, Traumastem ENDO Applicator; EMOXICEL EMIPOL; Traumastem P
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Oxidized cellulose; Haemostatic agent
Assessing Dietary Requirements in Relation to Resting Metabolic Rate in Spinal Cord Injury
Condition: Spinal Cord Injuries; Dietary Habits
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Observational

Summary: 
      Assess the relationship between body composition, metabolism, and dietary needs in people
      with spinal cord injury compared to their healthy controls that are age and sex matched.
    

Detailed description: 
      This study will quantify body composition and resting metabolic rate and then compare these
      parameters to results from a nutritional analysis. Participants will have two study visits
      that include physical exam, blood draws, resting metabolic rate, Dual Energy X-ray
      Absorptiometry (DXA) scan, and dietary assessments.
    

Intervention name(s): Resting Metabolic Rate; Body Composition; Dietary Assessment
Intervention type(s): Diagnostic Test; Diagnostic Test; Behavioral
Intervention description(s): 30 minute test to determine daily caloric needs; Total Body DXA scan to determine fat mass, fat-free mass, and percent body fat; Self administered dietary logs
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Spinal Cord Injury subjects and healthy controls across central Pennsylvania.
      
Keywords: Resting Metabolic Rate
Microglia Activation in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      Patients with schizophrenia have volume loss in gray matter. This study is designed to
      evaluate whether their is microglia activation in schizophrenia using [11C](R)-PK11195 PET.
    

Detailed description: 
      Schizophrenia is a complex and chronic disease that affects different aspects of cognition
      and behaviour, including attention, perception, thought processes, emotion and volition.
      Schizophrenia is a brain disease particularly involving decrement in gray matter as has been
      supported by findings from many imaging studies. The pathophysiology of these gray matter
      changes has not been clarified. Microglia activation is the consequence of virtually all
      conditions associated with neuronal injury. When activated following neuronal damage,
      microglia show a marked increase in the expression of peripheral type benzodiazepine binding
      sites which are particularly abundant on cells of the mononuclear macrophage.

      (R)-PK11195 [1-(2-chlorophenyl)-N-methyl-N-1(1-methylpropyl]-3 isoquinolinecarboxamide) is a
      highly selective ligand for the peripheral benzodiazepine binding site. (R)-PK11195, labelled
      with the positron emitter carbon-11, can be used to monitor the peripheral type
      benzodiazepine receptors using Positron Emission Tomography (PET). At the Vrije Universiteit
      Medical Centre (R)-[11C]PK11195 is used for studying microglia activation in-vivo in patients
      with traumatic brain damage, minimal cognitive impairment and Alzheimer disease.

      The objective of this study is to determine whether and to what extent microglia activation
      occurs in schizophrenia. Ten patients with schizophrenia will be recruited and 10 controls,
      matched for age and gender. This is an open study. The study consists of one PET scan, which
      will be performed at the Clinical PET Centre of the Vrije Universiteit Medical Centre. All
      subjects will also get a MRI scan, which will be performed at the department of Radiology,
      University Medical Centre Utrecht.
    

Intervention name(s): Positron Emission Tomography
Intervention type(s): Device
Intervention description(s): camera is new
Other intervention name(s): Siemens HR+
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: schizophrenia; microglia; PET
A Bioequivalence Study of a New Paracetamol Oral Suspension 24mg/ml Compared to the Marketed Paracetamol Oral Suspension (Panadol Baby and Infant 24mg/ml) in Healthy Adult Subjects
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study is to compare the bioequivalence of a New Paracetamol Oral
      Suspension 24 milligram/milliliter (mg/ml) with that of an already approved Paracetamol (24
      mg/ml) Oral Suspension (Panadol Baby & Infant) when administered to healthy volunteers under
      fasting condition. Pharmacokinetic parameters will be calculated from plasma concentration
      data. The rate and extent of absorption of the formulations will be compared.
    

Detailed description: 
      This will be a 2-arm, single center, single dose, open-label, randomized, two-sequence, two
      period crossover, bioequivalence study in healthy adult participants. Participants will be
      screened for eligibility within 15 days prior to dosing. Participants will receive each of
      the two study treatments in fasted state during a 6-day (5-overnight stay) residential period
      at the study site. Participants will receive both treatment regimens in a randomized order
      with a 72-hour washout period between each dose. During each treatment period, a total of 21
      blood samples will be collected which will include a pre-dose blood sample 1 hour before
      dosing and 20 post-dose blood samples at 5, 10, 20, 30, 40, 50, 60, 80, 90, 120, 150, 180
      minutes, 4, 5, 6, 8, 10, 12, 14, 16 hours, for bioanalytical analyses of paracetamol.

      Vital signs, clinical safety laboratory tests and monitoring of adverse events will be used
      to assess the safety and tolerability of the study products.
    

Intervention name(s): New Paracetamol Oral Suspension (24 mg/ml); Panadol B&I Oral Suspension (24 mg/ml paracetamol)
Intervention type(s): Drug; Drug
Intervention description(s): After an overnight fasting for at least 10 hours, New Paracetamol Oral Suspension (24 mg/ml) in a volume of 42 ml will be administered orally via a single use syringe by a trained study person to the study participants as per the randomization schedule in each period.; After an overnight fasting for at least 10 hours, Panadol B&I Oral Suspension (24 mg/ml paracetamol) in a volume of 42 ml will be administered orally via a single use syringe by a trained study person to the study participants as per the randomization schedule in each period.
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a 2-arm, single center, single dose, open-label, randomized, two sequence, two-period crossover, bioequivalence study in healthy adult subjects, separated by one wash-out period of at least 72 hours.
Masking: None (Open Label)
Primary purpose: Basic Science
Budesonide for Maintenance Treatment of Collagenous Colitis
Condition: Collagenous Colitis
MeSH terms: Colitis; Colitis, Collagenous
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether orale budesonide is effective in
      maintaining clinical remission in patients with collagenous colitis.
    

Detailed description: 
      The purpose of this study is to determine whether orale budesonide is effective in
      maintaining clinical remission in patients with collagenous colitis.
    

Intervention name(s): Budesonide
Intervention type(s): Drug
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: collagenous colitis; microscopic colitis; budesonide
Treatment With Cidofovir for Children With Laryngeal Papillomatosis (Warts in the Throat)
Condition: Papilloma
MeSH terms: Papilloma
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to see what dose of the drug cidofovir is safe to treat
      laryngeal papillomatosis (warts in the throat which occur over and over) in children.

      Laryngeal papillomatosis is caused by infection with a virus called human papillomavirus
      (HPV). At present, there is no approved drug to treat this infection. However, cidofovir is a
      drug effective against several viruses. Cidofovir may be able to attack the HPV virus. This
      study tests the safety of giving this drug to children.
    

Detailed description: 
      Your child will be assigned randomly (like tossing a coin) to receive either cidofovir or
      placebo (an inactive substance). Neither you nor your doctor will know which your child is
      receiving. Your child will undergo a total of 6 bronchoscopic procedures, which involves
      placing a tube down your child's throat so that the warts can be seen and treated. The warts
      will be removed by laser or other procedures and the study drug injected. Study drug will be
      injected at the sites of all newly removed warts and warts which were removed during earlier
      study visits. This procedure will be performed every other week. Blood and urine tests will
      also be performed at this time. Your child will be under general anesthesia during each
      procedure and will be in the surgery unit for about 6 to 8 hours. Your child will also have
      to be seen by the doctor 2 days after the procedure. Your child will be followed for a total
      of 5 years to make sure he/she develops normally and to monitor any side effects of
      cidofovir. Follow-up visits will take place at Months 3, 6, and then once every 6 months
      through Year 5. If necessary, laser or other procedures will be performed at these visits to
      remove any warts.
    

Intervention name(s): Cidofovir
Intervention type(s): Drug
Intervention MeSH terms: Cidofovir
Masking: Double
Primary purpose: Treatment
First-in-man Study of Single and Multiple Ascending Doses of a New Drug for Neurological Disorders
Condition: Healthy Subjects
MeSH terms: Nervous System Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this first-in-man study is to investigate whether a new drug for
      neurological disorders is safe and well-tolerated when administered orally to healthy adults
    


Intervention name(s): AC-082; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Hard gelatin capsules for oral administration; Matched placebo capsules for oral administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: healthy subjects; first-in-man; safety