bioihbjkbjnl/mcl2 huggingface dataset:
Early CPAP in COVID-19 Patients With Respiratory Failure.
Condition: CPAP Ventilation; COVID-19; Emergency Departments
MeSH terms: COVID-19; Respiratory Insufficiency; Emergencies
Study type: Interventional

Summary: 
      The study aims at clarifying whether early treatment with continuous positive airway pressure
      (CPAP) ventilation is able to reduce the need for intubation or death in patients visiting an
      emergency department (ED) with known or suspected COVID-19 infection and insufficiency
      respiratory.
    

Detailed description: 
      Eligible patients will be randomized to two treatment arms: current clinical practice
      (control arm) and early treatment with CPAP in addition to current clinical practice
      (experimental arm). To deal with the current emergency situation, the study will adopt an
      adaptive design with a Bayesian continuous monitoring. Such design allows to stop the study
      as soon as the data provide sufficient evidence of efficacy or ineffectiveness of the studied
      treatment.

      The primary endpoint of the study is the combination of intubation or death within 7 days of
      randomization. The secondary endpoint is 30-day mortality.

      All patients arriving at the ED will be evaluated to verify the presence of inclusion and
      exclusion criteria. Randomization will be performed through an ad-hoc electronic case report
      form (eCRF). Eligible patients should be randomized as soon as possible, possibly immediately
      after the ED triage.

      Patients randomized to the control arm will be treated according to current clinical
      practice, which currently does not involve the use of CPAP. Therefore, these patients should
      not start treatment with CPAP immediately after randomization. CPAP treatment, however, is
      allowed at a later stage, if deemed appropriate according to clinical judgment.

      Patients randomized to the experimental arm should begin treatment with CPAP as soon as
      possible. CPAP should only be performed with a helmet, using a positive end-expiratory
      pressure (PEEP) between 8 and 14 cmH2O and an inspired oxygen fraction (FiO2) between 40 and
      60%. FiO2 and PEEP must be modulated, within the limits indicated above, so as to obtain a
      saturation > 94%. Whenever this goal cannot be achieved, the patient should be referred to
      the intensivist.
    

Intervention name(s): CPAP treatment
Intervention type(s): Device
Intervention description(s): CPAP should be performed as soon as possible and only with a helmet, using a positive end-expiratory pressure (PEEP) between 8 and 14 cmH2O and an inspired oxygen fraction (FiO2) between 40 and 60%.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cimetidine Biowaivers
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this research is to see if non-drug ingredients in capsules and oral solutions
      affect how well drugs are absorbed. This is called "bioequivalence." Medications taken by
      mouth, such as capsules and solutions, need to be absorbed into the body in order to do any
      good. Capsules and solutions contain a drug, but also contain non-drug ingredients that are
      called excipients or fillers. Excipients in the capsules and solutions can impact how much
      drug is absorbed into the body. This is called "bioINequivalence." Capsules and solutions in
      this research contain the drug cimetidine. This drug is being used since it has high water
      solubility (can dissolve in water) and low ability to be absorbed.
    

Detailed description: 
      The investigators anticipate that common excipients do not cause bioINequivalence. 1) The
      hypothesize is that commonly used excipients in oral medications change the rate or extent of
      Class 3 drug absorption and result in bioINequivalence. 2) Alternative hypothesis is that
      commonly used excipients in oral medications do not change the rate or extent of Class 3 drug
      absorption and do not result in bioINequivalence.
    

Intervention name(s): Drug: cimetidine
Intervention type(s): Drug
Intervention description(s): cimetidine 200mg total dose (single dose) as either CimTest-A capsules, CimTest-B capsules, sorbitol-free solution, or commercial cimetidine solution
Other intervention name(s): Tagamet
Intervention MeSH terms: Cimetidine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: cimetidine; pharmacokinetics; formulation
Short Term Effects of HMG-CoA Reductase Inhibition (Atorvastatin)on Renal Hemodynamics, Tubular Function and Vasoactive Hormones on Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      We wanted to test the shortterm effects of HMG-CoA reductase inhibition (atorvastatin) on
      renal hemodynamics, renal tubular function and vasoactive hormones on healthy subjects.
    


Intervention name(s): HMG-CoA reductase inhibition (atorvastatin)
Intervention type(s): Drug
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Keywords: HMG-COA reductase inhibition; GFR; RPF; FE; CL
An Open Trial to Assess the Tolerability of AVANZ Phleum Pratense Immunotherapy
Condition: Allergic Rhinoconjunctivitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to assess the tolerability of AVANZ.
    

Detailed description: 
      To assess the tolerability of the up-dosing phase of AVANZ Phleum pratense. The frequency of
      patients with adverse reactions will be the study primary endpoint.
    

Intervention name(s): AVANZ Phleum pratense
Intervention type(s): Drug
Intervention description(s): AVANZ Phleum pratense up-dosing phase (300, 600, 3000, 6000 and 15,000 SQ+) + one 15,000 SQ+ maintenance injection
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Human Oral Detection of Glucose Olygomers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 4

Summary: 
      Although salivary contents play a major role in the early stage of food digestion process,
      their role in taste perception of glucose polymers is essentially unknown. It is hypothesized
      that the differences in salivary contents, more specifically salivary amylase concentration
      and activity, influence taste perception of glucose polymers and ultimately eating behavior,
      which is related to risks in various diseases. The current project will investigate the
      variation in salivary contents across individuals and its role in taste perception of glucose
      polymers.
    


Intervention name(s): Acarbose
Intervention type(s): Drug
Intervention description(s): Acarbose solution will be swabbed on the tip of the tongue to inhibit salivary alpha amylase activity; each swab will contain ~484 microgram acarbose; total maximum exposure of each subject to acarbose will be ~14-30 mg each session (1-20 sessions)
Intervention MeSH terms: Acarbose
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Duplex Guided Application of Local Anesthetic Before Femoral Artery Catheterization
Condition: Local Anesthetics; Ultrasound Guidance; Catheterization
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of this study is to evaluate the optimization of local anesthetic effect with duplex
      ultrasound-guided injection of lidocaine before femoral artery puncture during diagnostic or
      therapeutic interventional procedures.

      In total, 200 patients scheduled for various diagnostic or therapeutic interventional
      radiology procedures requiring femoral artery puncture, will be randomized in two groups
      after informed consent. Patients will be randomized to undergo groin local anesthesia with
      the proposed method of duplex ultrasound guided injection of lidocaine versus standard
      injection of lidocaine with manual palpation (control group).

      The protocol includes the registration of patients' demographics (age, gender, risk factors
      for peripheral arterial disease), arterial morphological characteristics (calcifications and
      presence of atheromatous disease), as well as technical details of the procedure (total
      puncture duration, sheath size, antegrade/retrograde puncture, etc.)

      Primary study endpoint will be peri-procedural pain that will be assessed with the use of a
      visual analog scale (VAS) completed by the patient at the end of the procedure. Secondary
      study endpoints will evaluate procedural safety and complications during the immediate
      post-procedural period (up to 7 days).
    


Intervention name(s): Ultrasound guided injection of femoral local anesthetic (lidocaine); Injection of femoral local anesthetic (lidocaine) with manual palpation
Intervention type(s): Procedure; Procedure
Intervention description(s): Injection of lidocaine (< 10 mls of lidocaine, 1%w/v) before femoral artery puncture with free-hand duplex ultrasound guidance.; Injection of lidocaine before femoral artery catheterization with manual palpation.
Intervention MeSH terms: Lidocaine; Anesthetics, Local; Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: femoral artery puncture; local anesthesia; ultrasound guided
Safety and Immunogenicity Assessment of Rotavin-M1 in Vietnamese Children
Condition: Diarrhea; Fever; Nausea; Vomit; Irritability
MeSH terms: Nausea; Diarrhea
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a multiple-site phase 2b, randomized, placebo control study to evaluate the safety
      and immunogenicity of Rotavin-M1, produced by the Center for Research and Production of
      Vaccines and Biologicals, Vietnam.
    

Detailed description: 
      The investigators evaluate the vaccine schedule consisting of 2 doses of Rotavin-M1,
      10e6.3ffu/dose at 2 month interval in children in two study sites, Thanh Son- Phu Tho and
      Thai Binh city-Thai Binh provinces.

      This vaccine dose and schedule was chosen based on results from the previous dose-escalating
      study (NCT01377571).
    

Intervention name(s): Rotavin-M1; cell culture medium in absence of virus
Intervention type(s): Biological; Biological
Intervention description(s): liquid, 10e6ffu/dose, 2 doses, 2 month interval; Placebo
Other intervention name(s): KH0118; POLYVAC; G1P[8]
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: diarrhea; fever; nausea; vomit; irritability
Simple Decompression Versus Anterior Transposition of the Ulnar Nerve
Condition: Humeral Fractures; Ulnar Nerve Compression
MeSH terms: Ulnar Nerve Compression Syndromes; Fractures, Bone; Humeral Fractures
Study type: Interventional

Summary: 
      Both simple decompression and anterior transposition of the elbow nerve (ulnar nerve) for
      acute displaced fractures of the elbow (distal humerus) treated with plate fixation are
      currently used by surgeons. We want to examine which treatment will overall give better
      results in regards to arm function and residual pain.
    


Intervention name(s): Simple decompression; anterior subcutaneous transposition
Intervention type(s): Procedure; Procedure
Intervention description(s): Fracture fixation will be performed through a posterior approach, as this provides excellent visualization of the distal fragments. A triceps split will be used to expose the distal humerus. A midline incision will be made from proximally to distal onto the shaft of the ulna. Equal portions of the triceps muscle will be reflected medially and laterally, with use of sharp dissection to remove the triceps insertion from the olecranon. The ulnar nerve will be identified and protected proximal and distal to the medial epicondyle. Fracture fixation will be performed after anatomic reduction using standard fixation techniques and plate fixation on both the medial and lateral column.
In the simple ulnar nerve decompression group, no further treatment of the ulnar nerve will be undertaken.; In the anterior transposition of the ulnar nerve group, the ulnar nerve will be placed subcutaneously anterior to the medial epicondyle free from any pressure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: distal humerus; fractures; ulnar nerve; simple decompression; anterior transposition
Prevalence of EED and Quality of Life Evaluated by Gastroesophageal Reflux Disease (GERD)-Q in Korean GERD Patients
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Observational

Summary: 
      The purpose of this study is to asses the EED symptom prevalence in Koran GERD patients with
      typical reflux symptom and to evaluate quality of life with the scales including Gerd Q.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        general hospital sample
      
Keywords: GERD; Korea; typical symptom; quality of life; Naturalistic; epidemiological
The Effect of Social Skills Intervention on Praxis and Social Functioning in Individuals With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      This study will be carried out with individuals diagnosed with schizophrenia who continue to
      community mental health. Social skills training will be applied in the study. This study will
      be conducted to examine the effect of social skills training on praxis and social
      functionality in individuals with schizophrenia.
    

Detailed description: 
      This study will be conducted to examine the effect of social skills training on praxis and
      social functionality in individuals with schizophrenia. Test of Upper Limb Apraxia (TULIA)
      will be used for praxis assessment. Social Functioning Assessment Scale (SFAS) will be used
      for social functioning assessment. In this study, individuals with schizophrenia will be
      examined with the Model of Creativity Ability as an occupational therapy model and role
      playing activities will be determined according to the model. In secondary outcomes, the
      effect of social skills training on the symptoms of schizophrenia will be examined. therefore
      Scale for the Assessment of Positive Symptoms - SAPS and Scale for the Assessment of Negative
      Symptoms - SANS will be used in the study.
    

Intervention name(s): Social skills training
Intervention type(s): Behavioral
Intervention description(s): In this training, role-playing will be done in groups of six. In these role playing, the importance and application of the social skill specified before the session will be studied.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 groups, an application and a control group, will be used. Social skills training will be applied to one of the two groups with schizophrenia and not to the other group.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: schizophrenia; Social Skills; Apraxia, Motor; Social Functioning
Probiotics in Paediatric Asthma Management
Condition: Asthma in Children
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Randomized controlled double-blind trial in a child population with allergic asthma and
      recurring wheezing, undergoing probiotic treatment with Bifiasthm with the aim of assessing
      the reduction in asthma attacks.
    

Detailed description: 
      Allergic disorders have dramatically increased in prevalence over the past decade,
      particularly in developed countries, and primary prevention of allergic disease has proved an
      elusive goal. There is increasing evidence that the airway microbiome influences the
      development of wheezing and childhood asthma. Probiotics are increasingly considered as a
      promising treatment for the correction of dysbiosis, reduction of systemic inflammation, and
      modulation of allergic diseases. The aim of this study is, therefore, to evaluate the
      efficacy of Bifidobacterium breve B632 (DSM 24706) and Lactobacillus salivarius LS01 (DSM
      22775) in the prevention of asthmatic allergies in human subjects.
    

Intervention name(s): Bifiasthm; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Subjects will be instructed to take an active or placebo sachet twice daily for eight weeks, and subsequent intake of one dose daily for a further eight weeks.; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled double-blind trial
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Cerebral Edema in Pediatric Diabetic Ketoacidosis
Condition: Diabetic Ketoacidosis
MeSH terms: Brain Edema; Ketosis; Acidosis; Diabetic Ketoacidosis
Study type: Interventional

Summary: 
      The purpose of this trial is to compare two different rates of fluid administration during
      diabetic ketoacidosis (DKA) treatment in children to determine which fluid administration
      rate is more beneficial for brain metabolism and for preventing or decreasing brain swelling
      during DKA.
    

Detailed description: 
      Cerebral edema (swelling of the brain) is the most frequent serious complication of diabetic
      ketoacidosis (DKA) in children. The cause of cerebral edema during DKA is not well
      understood. Recent studies suggest that it may result from lack of adequate blood flow to the
      brain during DKA, before treatment starts. Brain injury, resulting in edema, may occur before
      treatment because of lack of adequate blood flow to the brain and additional injury may occur
      when adequate blood flow is re-established during treatment (called reperfusion injury).
      Because additional injury may occur during treatment, it is important to understand whether
      the rate of administration of intravenous fluids, and, therefore, the speed of reperfusion of
      the brain, is related to the degree of brain swelling and injury. Most current treatment
      protocols indicate that intravenous fluids should be administered slowly, but it may be
      possible that brain injury and swelling might be lessened if adequate blood flow is
      established more quickly.

      In this study, researchers will use magnetic resonance (MR) imaging to compare two different
      rates of fluid administration during DKA treatment in children. The investigators will use MR
      imaging to measure brain swelling and metabolism at three time points-twice during treatment
      and once after recovery from DKA-and will compare these measurements to determine which fluid
      administration rate has more beneficial effects on brain metabolism and brain swelling.

      The study's researchers hypothesize that more rapid re-establishment of blood flow to the
      brain (via more rapid administration of intravenous fluids) will result in less brain
      swelling and injury than slower rehydration with delayed re-establishment of adequate brain
      blood flow will.
    

Intervention name(s): intravenous fluid treatment
Intervention type(s): Other
Intervention description(s): infusion of intravenous fluids (0.9% saline and 0.45% saline)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: diabetic ketoacidosis; DKA; cerebral edema; brain edema
Management of Post Dural Pucture Headache After Lower Limb Surgeries: Oral Prednisolone vs Oral Pregabalin
Condition: Analgesia
MeSH terms: Post-Dural Puncture Headache; Headache
Study type: Interventional

Summary: 
      The aim of this study is to compare between oral prednisolone and oral pregabalin in
      management of PDPH to detect effectiveness of the treatment in reducing severity of PDPH,
      total rescue analgesic consumption and adverse effects of prednisolone and pregabalin in
      patients undergoing lower limb surgery.
    

Detailed description: 
      1. To compare between oral prednisolone and oral pregabalin in reducing severity post-dural
           puncture headache after spinal anesthesia in patients undergoing lower limb surgeries.

        2. To calculate total amount of postoperative analgesic requirement for 72 hours after the
           onset of the headache in all patient groups.

        3. To detect any side effects of the study medications in all patient groups.
    

Intervention name(s): caffeine, paracetamol tablet; Oral prednisolone; oral pregabalin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral fluid intake, recumbent positioning, combination of paracetamol and caffeine tablet three times per day for three days (2 tablets of Panadol-Extra tablet, film coated, GlaxoSmithKline Consumer Healthcare Holdings (US) LLC were given every 8hours) and stool softener and to maintain blinding a tablet of vitamins was given twice per day for three days.; patients who received conservative treatment as control group together with oral tablet prednisolone 20 mg once daily plus one tablet of vitamins to maintain blinding for three days. .; patients who received conservative treatment as control group together with oral tablet pregabalin 150 mg twice per day for three days.
Intervention MeSH terms: Acetaminophen; Prednisolone; Pregabalin; Caffeine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Analgesic management of post dural puncture headache: oral prednisolone vs oral pregabalin
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: oral prednisolone; oral pregabalin; post dural puncture headache (PDPH); lower limb surgeries
Bioavailability, Pharmacokinetics and Safety Evaluation of Phencynonate Hydrochloride in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the bioavailability of two formulations (Taiwan and
      China mainland) of phencynonate hydrochloride tablets and to generate pharmacokinetic and
      safety profiles of phencynonate hydrochloride in healthy volunteers.
    


Intervention name(s): Phencynonate hydrochloride
Intervention type(s): Drug
Intervention description(s): 2mg/tablet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Bioavailability; Pharmacokinetics; Safety Evaluation