bioihbjkbjnl/mcl2 huggingface dataset:
Comparative Pharmacokinetics of AFOLIA and Gonal-f® After Single Subcutaneous Application
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Comparative pharmacokinetics study after single subcutaneous application of AFOLIA and the
      reference product (Gonal-f®).

      Objective: To demonstrate equivalence within the 80%-125% margin of the reference product for
      the area under the curve (AUC) of AFOLIA compared to (Gonal-f®).
    


Intervention name(s): AFOLIA; Gonal-f
Intervention type(s): Drug; Drug
Intervention description(s): single sc injection, 225 IU; single sc injection, 225IU
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: recombinant human follicle stimulating hormone; pharmacokinetics; bioequivalence
Influence of Food on the Bioavailability of Telmisartan / Ramipril Fixed Dose Combination in Healthy Male and Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective was to investigate the relative bioavailability of the fixed dose combination
      (FDC) tablet (80 mg telmisartan / 10 mg ramipril) after food intake in comparison to the
      bioavailability of the FDC tablet while fasting.
    


Intervention name(s): Telmisartan/Ramipril, fixed dose combination tablet; high fat, high caloric meal
Intervention type(s): Drug; Other
Intervention MeSH terms: Telmisartan; Ramipril
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of CB-183,315 in Participants With Clostridium Difficile Associated Diarrhea (MK-4261-006)
Condition: Clostridium Difficile Infection
MeSH terms: Clostridium Infections; Diarrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      A total of 608 participants with Clostridium Difficile Associated Diarrhea (CDAD) will
      participate in this study; participants will receive either oral vancomycin or CB-183,315 in
      a blinded fashion. Treatment will last for 10 days and participants will be followed up for
      at least 40 days and a maximum of 100 days. The purpose of this study is to evaluate how well
      CB-183,315 treats CDAD as compared to vancomycin.
    


Intervention name(s): CB-183,315; Vancomycin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): CB-183,315 250 mg white coated tablet over-encapsulated in a size 00 opaque hard gelatin capsule.; Vancomycin hydrochloride 125 mg capsule over-encapsulated in size 00 opaque hard gelatin capsule.; Placebo size 00 opaque hard gelatin capsules.
Other intervention name(s): Surotomycin
Intervention MeSH terms: Vancomycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: CDAD; Clostridium difficile Associated Diarrhea; CDI; Clostridium difficile Infection; Diarrhea
Validation of Brain Function Assessment Algorithm for mTBI/Concussion
Condition: Brain Injuries, Traumatic; Concussion, Mild; Concussion, Severe; Concussion, Intermediate; Concussion, Brain
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
Study type: Observational

Summary: 
      This study is Part 2 of data collection from 13-25 years old subject population for
      validation of previously derived algorithms. This data will be combined with that collected
      under NCT02957461 (Part 1 with subject age range 18-25 years) for the final analyses of
      validation of the algorithms.
    

Detailed description: 
      EEG, neurocognitive performance and clinical data will be collected at time of injury (within
      3 days) at clinically determined Return to Play (RTP) and 45 days after RTP, for the purpose
      of independently validating the performance of the algorithms developed in prior studies
      (NCT02477943, NCT02661633 and NCTXXXXXX). Data collected under this study will be combined
      with that collected under NCT02957461 for the final analyses of prospective algorithm
      performance in an independent population ages 13-25 years. Subjects will come from the sports
      and other populations of concussed individuals. They will be matched with controls i.e. not
      head injured subjects who will also undergo the same set of tests and the same time intervals
      as the injured subjects. An additional pool of uninjured (not head injured) subjects will be
      collected who will be assessed at a single time point.
    

Intervention name(s): BrainScope Ahead 300iP
Intervention type(s): Device
Intervention description(s): The BrainScope Battery evaluation will consist of 4 tests to aid in the assessment of concussion: History, Physical, signs and symptoms (SAC, SCAT5), Electrophysiological Function; Neurocognitive Performance Assessment, Ocular Motor Assessment. BrainScope Ahead 300iP will be used to perform EEG and Cognitive assessments.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Approximately 160 Injured and Matched Control subjects will be recruited from high schools,
        college universities, concussion clinics and emergency rooms.
      
Keywords: Concussion; Sports Related Concussion; Mild Traumatic Brain Injury; Non-Sport Related Concussion
Tilt Cardiopulmonary Resuscitation With a Feedback Device
Condition: Cardiopulmonary Resuscitation; Basic Cardiac Life Support
Study type: Interventional

Summary: 
      According to the European Resuscitation Council (ERC) Guidelines for patient to a depth of
      approximately 5-6 cm on a firm and flat surface when possible. However, Cardiopulmonary
      resuscitation (CPR) performers may need to continue the chest Resuscitation 2010, CPR
      performers should compress the sternum of a compression in an oblique direction, such as in
      elevators. For a pregnant patient in cardiac arrest, the 2010 ERC Guidelines recommend that
      the performer place the patient in a left-lateral tilt of 15 - 30° using a firm wedge to
      support the pelvis and thorax because the pregnant uterus can compress the inferior vena
      cava. We hypothesized Smartphone based chest compression feedback app would improves quality
      of CPR in an angulated surface.
    


Intervention name(s): Audiovisual feedback from smartphone based app
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Chest; Compression
Post-transplantation Cyclophosphamide as GVHD Prophylaxis After HSCT
Condition: Acute Myeloid Leukemia; Acute Lymphoid Leukemia; Lymphoma; Myelodysplastic Syndromes; Chronic Lymphocytic Leukemia; Immune System Diseases
MeSH terms: Leukemia; Preleukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic Syndromes; Immune System Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the efficacy of high-dose post-transplantation cyclophosphomide as
      graft-versus-host disease (GVHD) prophylaxis after allogeneic stem cell transplantation in
      patients with different risk of GVHD. The risk-adapted strategy involves using single-agent
      cyclophosphomide in recipients of matched bone marrow graft, and combining cyclophosphomide
      with tacrolimus and mycophenolate mofetil in recipients of matched peripheral blood stem
      cells and mismatched bone marrow.
    


Intervention name(s): Cyclophosphamide; Busulfan; Fludarabine monophosphate; Tacrolimus; Mycophenolate mofetil; Allogeneic hematopoietic stem cell transplantation
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Procedure
Intervention MeSH terms: Mycophenolic Acid; Cyclophosphamide; Busulfan; Fludarabine; Fludarabine phosphate; Tacrolimus
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cyclophosphamide; Leukemia; Lymphoma; Myelodysplastic Syndromes; Chronic Lymphocytic Leukemia; Immunosuppressive Agents; Immune System Diseases; Busulfan; Fludarabine; Tacrolimus; Mycophenolate mofetil; Antineoplastic Agents, Alkylating; Myeloablative Agonists; Hematopoietic Stem Cell Transplantation; Allogeneic
Effects of Plasmalogen on Obese Subjects
Condition: Obesity
Study type: Interventional

Summary: 
      This is a 12-week, randomized, double-blind, placebo-controlled study to evaluate the effects
      of scallop-derived plasmalogen on brain fatigue, body weight and changes in blood plasmalogen
      in obese subjects aged 20-75 years old.
    


Intervention name(s): Plasmalogen; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Treatment group takes two 0.5 mg plasmalogen capsules per day for 12 weeks.; Placebo Group takes two placebo capsules per day for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Perineural Injection Therapy Versus Steroid in Patients With Carpal Tunnel Syndrome
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with
      involving compression of the median nerve in the carpal tunnel. Rather than other progressive
      disease, CTS is characterized by remission and recurrence. Although many conservative
      managements of CTS, the effectiveness of these methods is insignificant or only persist for a
      short duration including steroid injection. Recently, the ultrasound-guided perineural
      injection with 5% dextrose was widely used for entrapment neuropathy with positive benefit.
      The investigators design a randomized, double-blind, controlled trail to assess the effect of
      ultrasound-guided perineural injection with 5% dextrose in patients with CTS and compared
      with steroid injection.
    

Detailed description: 
      After obtaining written informed consent, patients of clinically diagnosed with CTS were
      randomized into intervention and control group. Participants in intervention group received
      one-session ultrasound-guided perineural injection with 5% dextrose and control group
      received one-session ultrasound-guided perineural injection with steroid. No additional
      treatment after injection through the study period. The primary outcome is visual analog
      scale (VAS) and secondary outcomes include Boston Carpal Tunnel Syndrome Questionnaire
      (BCTQ), cross-sectional area (CSA) of the median nerve, sensory nerve conduction velocity of
      the median nerve, and finger pinch strength. The evaluation was performed pretreatment as
      well as on the 2nd week, 1st, 2nd, 3rd and 6 month after the treatment.
    

Intervention name(s): 5% dextrose; 1cc 2% Xylocaine+4cc Triamcinolone (40mg)
Intervention type(s): Drug; Drug
Intervention description(s): Ultrasound-guided perineural injection with 5% dextrose (5cc) between carpal tunnel and surrounding median nerve with hydrodissection.; Ultrasound-guided perineural injection with1cc 2% Xylocaine+4cc Triamcinolone (40mg) between carpal tunnel and surrounding median nerve with hydrodissection.
Intervention MeSH terms: Triamcinolone; Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: perineural injection; ultrasound-guided; dextrose; steroid
CARNIVAL Type I: Valproic Acid and Carnitine in Infants With Spinal Muscular Atrophy (SMA) Type I
Condition: Spinal Muscular Atrophy Type I
MeSH terms: Muscular Atrophy; Muscular Atrophy, Spinal; Spinal Muscular Atrophies of Childhood; Atrophy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a multi-center trial to test safety and evaluate early treatment intervention with
      valproic acid and carnitine in moderating SMA symptoms of Type I infants.
    

Detailed description: 
      Spinal muscular atrophy (SMA) is a genetic disorder that results in severe muscle weakness.
      It is one of the most common conditions causing muscle weakness in children. Patients with
      SMA most often develop weakness as babies or young children. Most people with SMA gradually
      lose muscle strength and abilities over time. Babies with the severe infantile form of SMA,
      SMA type I, usually lose abilities and strength quickly over a few weeks or months.

      Valproic acid (VPA) is a medicine that has been used for many years to treat patients with
      epilepsy. Recent research suggests that VPA may be able to upregulate expression of a backup
      copy of the SMN gene in SMA patient cell lines. In addition, some preliminary data suggests
      it may prolong survival in animal models of SMA. Because VPA can deplete carnitine in
      children with SMA Type I, carnitine is added to help prevent possible toxicity.

      In this multi-center trial, we will evaluate the effects of VPA/carnitine on infants with SMA
      type I. A variety of outcome measures, including assessment of safety, will be performed at
      each study visit to follow the course of the disease. The protocol includes two baseline
      visits over a period of two weeks, two clinical assessments on medication at 3 and 6 months,
      and then 6 months additional followup via telephone. Total duration of the study will be
      approximately 12 months.
    

Intervention name(s): Valproic Acid and Levocarnitine
Intervention type(s): Drug
Intervention description(s): Drug: Valproic Acid and Levocarnitine; syrup; dosage is by weight
Intervention MeSH terms: Valproic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Spinal Muscular Atrophy; SMA; Valproic Acid
The Effects of Caffeinated Coffee on Intraocular Pressure
Condition: Primary Open Angle Glaucoma
MeSH terms: Glaucoma, Open-Angle
Study type: Interventional

Summary: 
      High intraocular pressure (IOP) is a known risk factor for developing primary open-angle
      glaucoma (POAG). There is controversy in the literature regarding the degree to which
      caffeine influences IOP, with some studies reporting minimal changes in IOP while others
      report up to 4 mmHg increases. To date there are no double-masked randomized controlled
      trials that examine acute caffeinated coffee's effects on IOP in patients with or at risk for
      primary open-angle glaucoma. The investigators aim to better understand the relationship
      between acute caffeinated coffee (vs decaffeinate coffee) consumption and IOP in a
      double-masked, crossover randomized controlled clinical trial.
    


Intervention name(s): Caffeinated Coffee; Decaffeinated Coffee
Intervention type(s): Other; Other
Intervention description(s): Participants will drink one 8 oz cup in the morning hours. Participants have 15 minutes to drink the coffee but may do so in less time.; Participants will drink one 8 oz cup in the morning hours. Participants have 15 minutes to drink the coffee but may do so in less time.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Clinical Evaluation of Senofilcon A Contact Lenses Using a Novel Manufacturing Technology to Evaluate Overall Visual Acuity.
Condition: Visual Acuity
Study type: Interventional

Summary: 
      This study is a feasibility, multi-site, randomized, double-masked, 2-arm parallel group
      design, 2-week dispensing study with weekly visits to evaluate visual acuity.
    


Intervention name(s): senofilcon A contact lenses made with a novel manufacturing technology; senofilcon A contact lenses made with the current manufacturing technology
Intervention type(s): Device; Device
Intervention description(s): TEST Lens; CONTROL Lens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Intra-op POCUS for Identification of Endotracheal Tube Position in the Pediatric Population
Condition: Endotracheal Tube Wrongly Placed During Anesthetic Procedure
Study type: Observational

Summary: 
      Chest X-ray and/or fluoroscopy is not routinely used in the OR to confirm endotracheal tube
      (ETT) placement by anesthesiologists. Multiple studies have shown that ~19% of all
      intubations result in inappropriate ETT placement. An adult study has shown that ultrasound
      point-of-care is superior to auscultation in determining the location of ETT. This study aims
      to determine if point-of-care is useful in determining ETT position in children.
    

Detailed description: 
      Patients scheduled to have a procedure in the cardiovascular laboratory where fluoroscopy is
      routinely used will also undergo a point-of-care ultrasound exam to determine endotracheal
      tube position. An anesthesiologist will perform the ultrasound exam.
    

Intervention name(s): Point-of-care ultrasound exam; Reposition ETT
Intervention type(s): Device; Radiation
Intervention description(s): No intervention; ETT will be repositioned based on CXR by fluoroscopy
Other intervention name(s): POC ultrasound
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children who require general anesthesia and endotracheal intubation for procedures in the
        cardiovascular laboratory
A Prospective,Randomised, Open Label Study for Comparison of the Incidence and Severity of Postoperative Sore Throat (POST) Using C-MAC Video Laryngoscope and Traditional Macintosh Laryngoscope for Intubation
Condition: Hoarseness of Voice; Sore-throat
MeSH terms: Pharyngitis; Hoarseness; Dysphonia
Study type: Interventional

Summary: 
      The aim of this study is to compare the incidence of postoperative sore throat after
      intubation with two different types of laryngoscopes.
    

Detailed description: 
      Postoperative sore throat is a well known complication after endotracheal intubation. One of
      the major contributing factors is trauma associated with laryngoscopy. With decreased force
      applied to visualise cords, video laryngoscopes should decrease the incidence of
      postoperative sore throat. In this study we compared the incidence and severity of
      postoperative sore throat when laryngoscopy was done using c-mac video laryngoscope D-blade(
      group V) versus Macintosh laryngoscope (Group M). Method: Fifty four American society of
      Anaesthesiologists (ASA) 1&2 patients between age 18-60 years , undergoing laproscopic
      surgeries of short duration were included in this study and laryngoscopy was done with
      Macintosh laryngoscope in M group and with C MAC video laryngoscope D blade in V group.
      Patients were followed up 2hours, 6hours, 12hours and 24hours in postoperative period to see
      postoperative sore throat and hoarseness of voice .
    

Intervention name(s): Intubation
Intervention type(s): Procedure
Intervention description(s): Study groups Intubated with Macintosh or cmac video laryngoscopes
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A prospective,randomised, open label study
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Endotracheal tube; Postoperative sore throat; Hoarseness of voice; Macintosh laryngoscope; C-MAC video laryngoscope
Famotidine in Covid-19 Intensive Care Unit
Condition: COVID-19 Pandemic
MeSH terms: COVID-19
Study type: Observational

Summary: 
      The COVID-19 disease, caused by SARS-CoV-2 virus, started in December 2019 and created a
      pandemic with high mortality and morbidity. Since a fully proven treatment has not been
      developed, the efficacy of currently available treatments is being investigated. Famotidine,
      an H2Receptor blocker, is one of the drug treatments being investigated. In this study, we
      aimed to investigate the effect of Famotidine treatment on the clinic and mortality of
      Covid-19 patients treated in the intensive care unit.
    

Detailed description: 
      The computer and written records of the patients followed in the Covid-19 Intensive Care
      Units of a research hospital during the pandemic process will be examined. Patients over the
      age of 18 who have SARS-CoV-2 mRNA detected by nasopharyngeal PCR (Polymeraze Chaine
      Reaction) will be included in the study. Patients with immunosuppression, end-stage renal
      disease, liver disease, G6PD deficiency, ALT/AST >5, long QT syndrome in ECG, diagnosed with
      psoriasis, porphyria, pregnant, and allergic reactions to famotidine or similar drugs were
      excluded from the study. Patients' age, gender, comorbidities, smoking and APACHE II score
      will be recorded. Patients who were administered Famotidine 160 mg/day PO or nasogastric and
      were not given this treatment since their admission to the intensive care unit will be
      compared. The primary outcome will be the need for invasive mechanical ventilation, intensive
      care mortality, and both. As a secondary outcome, serum markers indicating the severity of
      the disease (Leukocytes, lymphocytes, neutrophils/leukocytes, platelets, ferritin, CRP,
      D-Dimer, fibrinogen, procalcitonin, IL-6, troponin, creatinine, AST, ALT, P/F ratio and
      lactate) will be recorded.
    

Intervention name(s): Famotidine Tablets
Intervention type(s): Drug
Intervention description(s): 160 mg/day Famotidine
Intervention MeSH terms: Famotidine
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The patients followed in the Covid-19 Intensive Care Units
      
Keywords: COVID-19 Intensive Care Unit; Famotidine; mortality; entubation
Efficacy and Safety of Ivabradine on Top of Atenolol in Stable Angina Pectoris
Condition: Angina Pectoris
MeSH terms: Angina Pectoris; Angina, Stable
Study type: Interventional
Phase: Phase 3

Summary: 
      To test whether ivabradine when given in combination with atenolol is able to improve the
      exercise tolerance of patients with stable angina pectoris
    


Intervention name(s): Ivabradine
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double