bioihbjkbjnl/mcl2 huggingface dataset:
To Test Bioequivalence Between Two Formulations of Paracetamol/Phenylephrine
Condition: Respiratory Tract Infections
MeSH terms: Respiratory Tract Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to assess bioequivalence between two paracetamol/ phenylephrine
      combination products.
    

Detailed description: 
      The study will be a single dose, randomized, two-way crossover study in 40 healthy subjects,
      with equal numbers of males and females. Drop-outs will not be replaced. The two doses of
      medication given in the study (a single dose in each of the two study periods) will be
      separated by a washout period of at least 7 days. In each study period, sixteen blood samples
      for pharmacokinetic analysis will be taken over 24 hours. Blood samples will be centrifuged
      and concentrations of paracetamol and phenylephrine in plasma will be measured using a
      validated chromatographic assay. Pharmacokinetic parameters will be calculated from plasma
      concentration data. The rate and extent of absorption of the formulations will be compared.
    

Intervention name(s): Paracetamol 500 mg/Phenylephrine 5 mg tablets; Paracetamol 1000 mg/Phenylephrine 10 mg sachet
Intervention type(s): Drug; Drug
Intervention description(s): 2 tablets to be administered orally with 240 ml of water with a 24 hour follow-up period; 1 sachet dissolved in 240 ml water and administered orally with a 24 hour follow-up period
Other intervention name(s): Sudafed PE Sinus Pain Relief™; Flu Plus Hot Lemon™ sachet
Intervention MeSH terms: Acetaminophen; Phenylephrine; Oxymetazoline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Nasal congestion, Headache
Doxycycline in Acute Traumatic Brain Injury
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      evaluate the impact of Doxycycline on both clinical outcome and blood levels of NSE in
      patients with TBI.
    

Detailed description: 
      1. Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy,
           Damnhour University.

        2. All Participants agreed to take part in this clinical research and provide informed
           consent. for unconscious participants, the informed consent was obtained from their
           legally authorized representative.

        3. Patients with moderate to severe TBI will be enrolled from Tanta university hospitals.

        4. Serum samples will be collected for measuring the biomarkers.

        5. Our design is randomized, controlled study.

        6. All enrolled patients will be divided into 2 groups, Group (1) 25 patients that receive
           doxycycline 100 mg twice daily, either orally or through a nasogastric tube for 5 days,
           and group (2) will be 25 patients will receive placebo in addition to the standard
           treatment.

        7. All patients will be followed up during ICU period.

        8. Statsicial tests appropriate to the study design will be conducted to evaluate the
           significance of the results.

        9. Measuring outcome: the primary outcome is the change in the serum level of acute brain
           injury biomarkers.

       10. Results, conclusions, discussion and recommendations will be given.
    

Intervention name(s): Doxycycline 100 MG Oral Tablet; placebo
Intervention type(s): Drug; Other
Intervention description(s): doxycycline 100 mg twice daily, either orally or through a nasogastric tube for 5 day; placebo in addition to the standard treatment.
Other intervention name(s): vibramycine
Intervention MeSH terms: Doxycycline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Regulatory Post-Marketing Surveillance Study for TETRAXIM™
Condition: Diphtheria; Tetanus; Pertussis; Poliomyelitis
MeSH terms: Whooping Cough; Tetanus; Diphtheria; Poliomyelitis; Tetany
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the safety of TETRAXIM™ administered in routine
      clinical practice according to Korea Food and Drug Administration Notification No. 2009-46
      "Basic standard for reexamination of new drug" based on the pharmaceutical law in Korea.
    

Detailed description: 
      Primary vaccination will be administered from 2 months and booster vaccination from age 4 to
      6 years.
    

Intervention name(s): TETRAXIM™: Combined adsorbed diphtheria, tetanus, acellular pertussis and enhanced inactivated polio
Intervention type(s): Biological
Intervention description(s): 0.5 mL, Intramuscular at 2, 4, 6 months (Primary) or at 4 to 6 years (Booster) vaccination
Other intervention name(s): TETRAXIM™
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diphtheria; Tetanus; Pertussis; Poliomyelitis; TETRAXIM™
Special Investigation in Patients With Rheumatoid Arthritis (HOPEFUL III Study), a Follow-up Survey of Study P12-069
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Observational

Summary: 
      The main objective of this study was to determine the ability to maintain response after
      discontinuation of adalimumab treatment and the secondary objective was to determine
      radiographic progression in participants participating in the study, including the percentage
      who displayed minimal progression.
    

Detailed description: 
      This was a two-arm, multi-center, Post Marketing Observational Study (PMOS) conducted in
      Japanese participants with Rheumatoid Arthritis (RA) who continued the one year observational
      period of study P12-069 (HOPEFUL II study; NCT01163292) and provided informed consent to
      participate in study P12-707 (HOPEFUL III study; NCT01346501), after completion of study
      M06-859 (HOPEFUL I study; NCT00870467). The study P12-707 provided an additional two years of
      observation for those participants who participated in study P12-069.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants with Rheumatoid Arthritis (RA) who continued the one year observational period
        of study P12-069 and provided informed consent to participate in study P12-707.
      
Keywords: Rheumatoid arthritis
Effects of PH3 in Diabetic Nephropathy
Condition: Diabetic Nephropathy
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this clinical study is to evaluate the effectiveness and safety of
      PH3 for patients with diabetic nephropathy.

      The secondary objectives are to identify the optimal dosage for subsequent studies and to
      provide basis for the next confirmatory study in study design, endpoints, and study
      methodologies.
    


Intervention name(s): PH3
Intervention type(s): Drug
Intervention description(s): Each PH3 tablet, 530 mg/tablet, contains 250 mg of active ingredient. The placebo tablet contains no active ingredient.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Fimasartan on Hypertensive Cardiac Disease With Left Ventricular Hypertrophy Estimated by ECG
Condition: Left Ventricular Hypertrophy; Hypertension
MeSH terms: Heart Diseases; Hypertrophy, Left Ventricular; Hypertrophy
Study type: Observational [Patient Registry]

Summary: 
      Assess the efficacy of fimasartan on left ventricular hypertrophy in hypertensive patients
    

Detailed description: 
      Patients who were diagnosed with left ventricular hypertrophy (LVH) by ECG at the start of
      the study are followed up at 3-month intervals for 1 year.

      Increase Fimasartan if blood pressure is not controlled.
    

Intervention name(s): Fimasartan
Intervention type(s): Drug
Intervention description(s): Fimasartan is a non-peptide angiotensin II receptor antagonist (ARB) used for the treatment of hypertension and heart failure.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Registered 319 people considering 30% dropout rate
A Study to Assess the Pharmacokinetics, Safety and Tolerability of CT327 in Healthy Male Volunteers
Condition: Safety
Study type: Interventional
Phase: Phase 1

Summary: 
      K-252a is a potent inhibitor of nerve growth factor (NGF) and therefore has the ability to
      inhibit keratinocyte proliferation. K-252a is strongly lipophilic and therefore passes freely
      into the cell membranes of keratinocytes and accumulates at a systemic level. In order to
      reduce the dermal absorption and reduce the possible long-term systemic toxicity this study
      will assess a PEGylated derivative of K-252a named CT327. This approach should improve the
      safety profile of the K-252a molecule while maintaining its activity. The primary objective
      is to assess the safety and tolerability of single and repeat doses of CT327 when applied
      topically to the skin of healthy male volunteers.

      The secondary objective is to evaluate the eventual systemic absorption (pharmacokinetics;
      PK) of CT327 following single and repeat doses in healthy male subjects.
    


Intervention name(s): 0.01% CT327 (or placebo); 0.001% CT327 (or placebo)
Intervention type(s): Drug; Drug
Intervention description(s): Cream (10 g) was applied at an even thickness over a test area on the back of 10 x 10 cm to give an exposure of 1000 μg/dm2.; Cream (10 g) was applied at an even thickness over a test area on the back of 10 x 10 cm to give an exposure of 100 μg/dm2.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Sepsis Post Market Observational Study and Potential Reduction of Time to Antibiotics - Baylor S&W
Condition: Sepsis; Adult Disease; Emergency Department; Severe Sepsis
MeSH terms: Sepsis; Toxemia; Emergencies
Study type: Observational

Summary: 
      The purpose of this study is to demonstrate that addition of the Monocyte Width Distribution
      (MDW) parameter to current standard of care improves a clinician's ability to recognize
      sepsis in the Emergency Department, resulting in earlier decision to administer antibiotics
      from time of ED presentation for sepsis patients (simulated primary endpoint), with
      concomitant reductions in length of stay and in-hospital mortality for those patients
      (secondary endpoints).
    

Detailed description: 
      The objective of this study is to develop a method for identifying sepsis patients from
      electronic health records (EHR) based on Sepsis-2 criteria. Sepsis patients will be
      identified using a Sepsis Definition which includes meeting SIRS score of ≥2 within 12 hours
      of ED presentation and any microbial testing ordered within 24 hours of ED presentation. The
      patient will be enrolled if it meets the Sepsis Definition and additional EMR data elements
      will be extracted to complete case report form. Furthermore, objectives include to confirm
      the clinical validity and performance of MDW in a control population of sepsis patients where
      MDW is measured but not reported to physicians. This study is an observational study which
      will simulate the decision impact of MDW on sepsis identification and patient management.
    

Intervention name(s): CBC-DIFF Monocyte Volume Width Distribution (MDW)
Intervention type(s): Diagnostic Test
Intervention description(s): MDW measurement used to detect sepsis. Results will not be used to manage patients.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All adult patients presenting to the ED where a CBC-Diff has been ordered by standard of
        care
The Effects of CBT and tDCS on Fibromyalgia Patients
Condition: Fibromyalgia; Chronic Pain
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Chronic Pain
Study type: Interventional

Summary: 
      Investigators are seeking to determine the effects of CBT, anodal tDCS over left DLPFC, and
      combined CBT+ tDCS on clinical pain and functioning among a sample of patients with
      fibromyalgia. This study will be the first randomized, double-blind, controlled study of tDCS
      technology as an adjunctive pain management strategy for fibromyalgia pain. Data from this
      trial will likely yield information regarding the feasibility and efficacy of tDCS+CBT as a
      chronic pain-management approach.
    

Detailed description: 
      Patients with fibromyalgia will complete questionnaires, six cognitive behavioral therapy
      sessions, quantitative sensory testing before and after the six therapy sessions, and undergo
      30 minutes of tDCS during each of the six therapy sessions.
    

Intervention name(s): Transcranial Direct Current Stimulation
Intervention type(s): Device
Intervention description(s): Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Fibromyalgia; Pain
Alzheimer's Disease: Therapeutic Potential of Estrogen
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a 15-month study to determine the effectiveness of hormone replacement therapy in
      improving memory and the ability to live independently in postmenopausal women with
      Alzheimer's disease.
    

Detailed description: 
      Estrogen is a naturally occurring hormone produced in a woman's body. The purpose of this
      15-month study is to determine the effectiveness of hormone replacement therapy in improving
      memory and the ability to live independently in postmenopausal women with Alzheimer's disease
      and without other dementias.

      Patients who volunteer for this study will either receive a patch containing 17-ß-estradiol
      or will receive an inactive placebo patch. In addition, patients will be given either
      medroxyprogesterone or an inactive placebo pill. Neither the volunteers nor the study staff
      will know which type of patch or pill a patient receives. Patients must be generally healthy
      and have mild-to-moderate dementia. There must be a patient caregiver who can watch for side
      effects and ensure that the patient takes the study medications on schedule. Patients will
      undergo neuropsychological tests and an evaluation of the ability to live independently at
      each visit as well as laboratory evaluations, such as the taking of blood. Each visit will
      last approximately 3 hours. A total of 160 participants are being recruited.
    

Intervention name(s): Transdermal estradiol; Medroxyprogesterone; Placebo Patch; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 50 micrograms (low-dose) or 100 micrograms (high-dose) transdermal 17-ß-estradiol patch, changed every 3 days, for 12 months; 2.5mg tablet daily for 12 months; Transdermal placebo patch, changed every 3 days, for 12 months; Placebo tablet daily for 12 months
Other intervention name(s): 17 (beta) estradiol transdermal patch; Estrogen replacement therapy; progesterone
Intervention MeSH terms: Medroxyprogesterone Acetate; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Medroxyprogesterone; Estradiol; Polyestradiol phosphate; Estrogens; Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alzheimer disease; Hormone replacement therapy; Postmenopausal women
Testing a CBT Program for Anxiety in Teenagers With Autism: A Feasibility Study
Condition: Anxiety; Autism
MeSH terms: Anxiety Disorders; Autistic Disorder
Study type: Interventional

Summary: 
      The objective is to investigate the feasibility of a newly developed manualised group
      Cognitive Behavioural Therapy (CBT) programme for anxiety in 15 teenagers (aged 13-17 years)
      with Autism Spectrum Disorder (ASD). Our aim is to focus primarily on acceptability and
      compliance with the program with some investigation of treatment effects on anxiety diagnosis
      and anxiety symptoms.
    


Intervention name(s): Cool Kids (Chilled) Anxiety program adapted to children and youths with autism and anxiety disorders.
Intervention type(s): Behavioral
Intervention description(s): CBT program for anxiety in teenagers with autism
Intervention model: Single Group Assignment
Intervention model description: Fifteen teenagers aged 13-17 years with an active ASD diagnosis and experiencing life interference anxiety symptoms will be divided into 3 groups and treated with the Cool Kids AST anxiety program
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CBT; Anxiety; Autism; Feasibility; Teenagers
Cangrelor to Clopidogrel or Prasugrel Transition Study
Condition: Coronary Artery Disease (CAD)
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      There are two separate objectives in this study:

        1. To demonstrate the pharmacodynamic (PD) profile when participants treated with cangrelor
           are switched to oral prasugrel 60 mg administered 30 minutes (min) after cangrelor
           infusion is discontinued

        2. To demonstrate the PD profile when participants treated with cangrelor are switched to
           oral clopidogrel 600 mg administered during or immediately after cangrelor infusion.
    


Intervention name(s): Cangrelor; Clopidogrel; Prasugrel
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Cangrelor intravenously (IV) administered as a 30 microgram (µg)/kilogram (kg) bolus, followed by 4 µg/kg/min infusion for 2 hrs on Day 1.; Clopidogrel 600 mg single oral dose; Prasugrel 60 mg single oral dose
Intervention MeSH terms: Clopidogrel; Prasugrel Hydrochloride; Cangrelor
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: CAD
Effects of an Adaptogenic Extract on Electrical Activity of the Brain in Elderly Subjects With Cognitive Impairment
Condition: Cognitive Impairment, Mild
MeSH terms: Cognitive Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, double-blind, placebo-controlled, two arm cross-over study to determine whether
      a specific combination of Andrographis paniculata and Withania somnifera can be regarded as a
      safe and effective treatment for cognitive deficits.
    


Intervention name(s): Andrographis and Withania; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Combination of Andrographis paniculata and Withania somnifera; Visually identical placebo capsule
Intervention MeSH terms: Andrographolide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Electroencephalography; Andrographis; Ashwagandha
Comparison of Two Spinal Needles Regarding Postdural Puncture Headache
Condition: Anesthesia; Adverse Effect, Spinal and Epidural, Headache; Complications; Anesthesia, Spinal and Epidural, in Pregnancy
MeSH terms: Post-Dural Puncture Headache; Headache
Study type: Observational

Summary: 
      The aim of the study is to observe the rate of postdural puncture headache observed after
      spinal anesthesia in cesarean section patients.

      Two kind of spinal anesthesia needles will be used:

        1. 26 Gauge Quincke (cutting-tip needle)

        2. 26 Gauge Atraucan (atraumatic needle)

      The investigators will observe:

        1. Number of spinal punctures

        2. Time required for the spinal anesthesia procedure

      Patients will be evaluated after 7 days for:

        1. Headache

        2. Backache
    

Detailed description: 
      It is a known phenomenon that spinal anesthesia sometimes results in headache.

      The aim of the study is to observe the rate of postdural puncture headache observed after
      spinal anesthesia in cesarean section patients.

      Two kind of spinal anesthesia needles will be used:

        1. 26 Gauge Quincke (cutting-tip needle)

        2. 26 Gauge Atraucan (atraumatic needle)

      We will observe:

        1. Number of spinal punctures

        2. Time required for the spinal anesthesia procedure

      Patients will be evaluated after 7 days for:

        1. Headache

        2. Backache

      2 kind of spinal anesthesia needles will be used, but no comparison will be made. This is an
      observational study. Although literature gives different rates of postdural puncture headache
      for these two needles, we observe the same rate of headache in our clinical practice. We want
      to define the real rate of postdural puncture headache in patients undergoing cesarean
      section with spinal anesthesia.
    

Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pregnant female patients between 18-40 years old undergoing cesarean section in Adiyaman
        University Research Hospital, Turkey.
      
Keywords: spinal anesthesia; spinal needle; cesarean section; headache; backache
Comparison of NoaScope to the Conventional Stethoscope for Auscultation of Heart and Lung Sounds
Condition: Chest Pathology
MeSH terms: Respiratory Sounds
Study type: Interventional

Summary: 
      Assessing non-inferiority of a newly developed electronic stethoscope NoaScope in comparison
      with the conventional 3M Littmann stethoscope
    

Detailed description: 
      The enrolled population will include adults with a history of heart and lung complications.
      The enhanced sound quality of the electronic stethoscope and its non-inferiority to the
      traditional/conventional 3M Littmann stethoscope will be assessed through auscultation
      examination of every patient by a health professional (consultant, medical resident, and
      house officer) with both the electronic stethoscope and 3M Littmann/traditional/conventional
      stethoscope
    

Intervention name(s): NoaScope
Intervention type(s): Device
Intervention description(s): Smart digital stethoscope
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic