bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Senofilcon A With New UV-blocker on a Neophyte Population
Condition: Visual Acuity
Study type: Interventional

Summary: 
      This is a 5-visit, single-arm, open-label, dispensing study. Each subject will be bilaterally
      fit with the test article for approximately 4 weeks of reusable daily wear with lens
      replacement occurring 2-weeks after initial dispensing. After 4 weeks of study lens wear,
      subjects will return to their habitual spectacles for one week.
    


Intervention name(s): senofilcon A
Intervention type(s): Device
Intervention description(s): TEST Lens
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Corneal Epithelial Autograft With Middle Lamellar Keratoplasty for Severe Ocular Burns
Condition: Ocular Burns
MeSH terms: Burns
Study type: Interventional

Summary: 
      The purpose of this pilot study is to explore whether corneal epithelial autograft (EA)
      combined with allogeneic middle lamellar keratoplasty (AMLK) is more effective than limbal
      autograft (LA) with AMLK for ocular surface reconstruction in patients with severe ocular
      burns.
    


Intervention name(s): EA and AMLK; LA and AMLK
Intervention type(s): Procedure; Procedure
Intervention description(s): A 7-9mm diameter corneal epithelial tissue will be obtained from the fellow eye using femtosecond laser technology. This epithelial autograft (EA) is then ready for transplantation on the disease eye, following the procedure of allogeneic middle lamellar keratoplasty (AMLK).; A 3-clock-hour limbal autograft (LA) will be obtained from the fellow eye. This is then ready for transplantation on the disease eye following the procedure of AMLK.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Exploration of Autonomic Nervous System by Photoplethysmography
Condition: Intervention Affecting Autonomic Nervous System
Study type: Observational

Summary: 
      The autonomic nervous system state (ANSS) and the autonomic nervous system state index
      (ANSSi) - two indices derived from the pulse photo-plethysmography analysis - have been
      recently advocated as a measure of sympathetic activity in the anesthetized patients, but
      their validity has not been yet demonstrated. We will conduct a study aiming to assess if
      ANSS and ANSSi reflect autonomic nervous system modulation on cardiovascular system in
      healthy humans under general anaesthesia.
    


Intervention name(s): autonomic nervous system analysis
Intervention type(s): Procedure
Intervention description(s): electrocardiographic and pulse-photoplethysmographic waves of patients under general anesthesia for laparoscopic cholecystectomy will be recorded on a laptop pc for offline analysis of autonomic nervous system modulation a three main time point: 1) at baseline, before general anesthesia induction, 2) five min after tracheal tube placement, 3) five min after pneumoperitoneum insufflation.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        adults scheduled for elective laparoscopic cholecystectomy under general anaesthesia
      
Keywords: autonomic nervous system; heart rate variability; laparoscopic surgery; general anesthesia; photoplethysmography
Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease (ApoE4 Carrier)
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, double-blind, placebo controlled, randomized, outpatient, multiple
      dose study in male and female patients ages 50 to less than 89 years with mild to moderate
      AD. Approximately 200 study sites in the US and Canada will be involved. Patients will be
      randomized to receive either bapineuzumab or placebo. Each patient's participation will last
      approximately 1.5 years.

      Bapineuzumab is a humanized monoclonal antibody, which binds to and clears beta amyloid
      peptide, and is designed to provide antibodies to beta amyloid directly to the patient.
    


Intervention name(s): Bapineuzumab 0.5 mg/kg; Placebo Control; Bapineuzumab 1.0 m/kg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): given by infusion every 13 weeks for a total of 6 infusions.; given by infusion every 13 weeks for a total of 6 infusions.; given by infusion every 13 weeks for a total of 6 infusions.
Other intervention name(s): AAB-001; AAB-001
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Sputum Induction by Physiotherapy and Hypertonic Saline Techniques in Asthmatic Children
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      This study evaluated whether physiotherapy is efficient in sputum induction and in evaluation
      of pulmonary inflammation in asthmatic children.
    

Detailed description: 
      The hypertonic saline is a traditional technique to collect induced sputum, it´s safe and
      viable in asthmatic children, as well as the technique of sputum induction and processing has
      been standardized for schoolchildren.

      Sometimes researchers have difficulties to obtain induced sputum in stable patients and it´s
      possible to use physiotherapy maneuvers to induced sputum. The manouvers are safe for adult
      and children asthmatics stable.

      This study aimed to evaluate the effectiveness to collect induced sputum by physiotherapy
      maneuvers.
    

Intervention name(s): physiotherapy techniques; hypertonic saline 3%; saline + physiotherapy maneuvers
Intervention type(s): Other; Other; Other
Intervention description(s): oscillating positive expiratory pressure during nonstop 5 minutes. After that more five minutes to a forced expiratory technique; four nebulizations with 3% hypertonic saline, the aerosol was generated by an ultrasonic nebulizer; sputum induction by hypertonic saline at 3% for seven minutes. And more five minutes under physiotherapists maneuvers
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients were randomized in first visits into crossover techniques: (i) hypertonic saline (3%) - HS technique; (ii) physiotherapy techniques (oscillatory positive expiratory pressure, forced expiration and acceleration of expiratory flow) - P technique; (iii) hypertonic saline + physiotherapy techniques - HSP technique. All children attended three visits and 90 samples were collected. All patients underwent induced sputum and pulmonary function before and after bronchodilator.
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Tolerability, and Profile of Action of Drug in the Body of NN9535 in Healthy Male Japanese and Caucasian Subjects
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this clinical trial is to assess and compare
      the safety and tolerability, as assessed by adverse events after multiple subcutaneous doses
      of NN9535 in healthy male Japanese and Caucasian subjects.
    


Intervention name(s): semaglutide; semaglutide; semaglutide; semaglutide; semaglutide; placebo; placebo; placebo; placebo; placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 0.1 mg once weekly, s.c. injection; 0.2 mg once weekly, s.c. injection; 0.4 mg once weekly, s.c. injection; 0.4 mg once weekly for 1 week, 0.8 mg once weekly for 7 weeks, s.c. injection; 0.4 mg once weekly for 1 week, 0.8 mg once weekly for 1 week, 1.2 mg once weekly for 6 weeks, s.c. injection; 0.1 mg once weekly, s.c. injection; 0.2 mg once weekly, s.c. injection; 0.4 mg once weekly, s.c. injection; 0.4 mg once weekly for 1 week, 0.8 mg once weekly for 7 weeks, s.c. injection; 0.4 mg once weekly for 1 week, 0.8 mg once weekly for 1 week, followed by 1.2 mg once weekly injections for 6 weeks, s.c. injection
Other intervention name(s): NN9535
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Improvements in Pneumonia Status After Oral Care Intervention in Taiwan
Condition: Pneumonia
MeSH terms: Pneumonia
Study type: Interventional

Summary: 
      The correlation between improvement in oral health, reduction in oral bacterial
      concentration, and status of pneumonia hospitalization remains unclear. To determine the
      effects of professional oral care intervention on the index of oral health, salivary and
      sputum bacterial concentrations, and pneumonia hospitalization status of nursing home
      residents using a quasi-experimental study. Two nursing homes were on demand selected as the
      intervention and control groups; in the intervention group, weekly professional oral care was
      administered in addition to regular oral care by trained dental hygienists. Demographic data
      and oral health status were analyzed. Total salivary and sputum bacterial concentrations were
      determined using real-time polymerase chain reaction.
    


Intervention name(s): Routine oral cleaning and professional oral care group
Intervention type(s): Other
Intervention description(s): Besides routine oral cleaning was conducted by caregivers, professional oral care intervention was conducted by dental hygienists, and it included muscle massage, oral cleaning, and oral health education once a week.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Oral care intervention; Nursing home residents
Clinical Efficacy of Respiratory Pediatric Physiotherapy on a Child With Hospital Treated Pneumonia
Condition: Pneumonia Childhood; Rehabilitation; Recovery of Function
MeSH terms: Pneumonia
Study type: Interventional

Summary: 
      The accumulation of secretions in the bronchopulmonary air network promotes the detriment of
      respiratory functions generating hypoxia and causing a decrease in the cardiac output
      requiring the use of mechanical ventilation and hemodynamic support. It is intended to
      control the accumulation of secretions by means of Respiratory Pediatric Physiotherapy (RPP)
      and to evaluate its effectiveness counting on biological plausibility.
    

Detailed description: 
      The OBJECTIVE of this research protocol is to evaluate the effectiveness of RPP compared to
      postural drainage plus compression to the muscle belly of the upper limbs, as an adjuvant
      treatment for children with pneumonia. It is expected that the clinical severity decreases by
      1.5 in the Wang score (a modification of the Silverman score), with a standard deviation of
      2.6 points and a decrease of two days in the hospital stay with a α 0.05 in a one-tail test,
      a P of 80% and a 95.5% confidence interval.
    

Intervention name(s): Respiratory Pediatric Physiotherapy; Control Group
Intervention type(s): Other; Other
Intervention description(s): Prolonged slow expiration Tracheal pumping Controlled expiratory flow exercises Forced expiration technique; Will be subject to muscle compressions of the upper limbs. Both groups will receive the usual treatment for pneumonia prescribed by their treating doctor.
Other intervention name(s): Fisioterapia torácica pediatrica
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The population will consist of children aged from 0 to 8 years old diagnosed with pneumonia with a development time less than 7 days. he sample calculation corresponds to 40 participants per group. The intervention group will be exposed to techniques such as prolonged slow expiration, controlled expiratory flow exercises, tracheal pumping and tracheal reflex. The control group will be subject to postural drainage plus compressions to the muscle belly of the upper limbs. Both groups will go through 10 sessions: One daily session from Monday to Friday with a duration of 10 to 15 minutes each
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pneumonia; Respiratory Pediatric Physiotherapy
pCONus Treatment of Wide Neck Intracranial Aneurysms
Condition: Intracranial Aneurysm
MeSH terms: Intracranial Aneurysm; Aneurysm
Study type: Observational

Summary: 
      To assess safety and efficacy of pCONus for the treatment of wide neck bifurcation aneurysms.
    

Detailed description: 
      Title: pCONus Treatment of Wide Neck Intracranial Aneurysms

      Acronym: pToWin

      Device: pCONus Bifurcation Aneurysm Implant

      Study design: Prospective, multicenter, single-arm clinical investigation

      Purpose: To assess safety and efficacy of pCONus for the treatment of wide neck bifurcation
      aneurysms

      Duration of the study: 48 months

      Sample size: 100 evaluable patients

      Number of sites: > 20

      Follow-up intervals: Two independent follow-ups (after 3-6 and 7-12 months) according to site
      specific standard
    

Intervention name(s): implantation of the pCONus Bifurcation Aneurysm Implant
Intervention type(s): Device
Intervention description(s): The device will be introduced through a regular microcatheter. After deployment of the device with the crown positioned in the aneurysm neck the aneurysm will be entered with a microcatheter to perform endovascular coil occlusion. After completion of the coiling procedure the pCONus device will be electrolytically detached from the insertion wire and only the crown and the shaft will remain as a permanent implant.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients harbouring an unruptured or ruptured bifurcation aneurysm, in which pCONus
        assisted coiling was judged to be the most appropriate treatment
      
Keywords: Aneurysm; bifurcation; wide neck; pCONus; intracerebral; stroke
Project Health Link: Connecting Patients With Services
Condition: Alcohol Abuse
MeSH terms: Alcoholism
Study type: Interventional

Summary: 
      This study will compare three alternative interventions in the emergency department (ED) to
      promote substance abuse assessment, referral, and treatment entry: 1) a 5 session
      strengths-based case management model (SBCM); 2) a 2-session motivational enhancement therapy
      (MET); or 3) a one-time brief informational feedback (BIF) session. The primary outcome
      variables for this trial include follow-through on receiving an assessment and referral, and
      treatment engagement. Additional outcomes include degree of treatment completion,
      alcohol-related measures, health service utilization, health status changes, and psychosocial
      factors.
    


Intervention name(s): Strengths Based Case Management; Motivational Enhancement Therapy; Brief Informational Feedback
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Use of Patiromer to Transition Chronic Kidney Disease Patients With Hyperkalemia to a Plant-rich Diet.
Condition: Chronic Kidney Diseases; Hyperkalemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hyperkalemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this proof-of-concept controlled-feeding study is to determine whether
      patiromer (Veltassa®, Relypsa, Inc., Redwood City, CA) can be used to maintain normal serum
      potassium concentrations in chronic kidney disease (CKD) patients who are transitioned to a
      plant-rich diet.
    


Intervention name(s): Patiromer; Research Diet Menu
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): Patiromer dosing will be determined based on fasting potassium concentrations measured at the end of each week, factoring in both the absolute concentration, as well as the rate of change. The baseline dose of patiromer will correspond to the study by Weir et al. (2015); 8.4-g once per day for participants with a baseline serum potassium of greater than or equal to 5.1 mEq/L.; During the study, participants will be asked to consume only the foods provided in the research diet
Other intervention name(s): Veltassa
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic kidney disease, stages 3B-4
Drug Interactions Between Silimarine and Darunavir/Ritonavir
Condition: HIV
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a clinical trial to characterize drug interactions between silimarine and the
      protease inhibitor darunavir/ritonavir.
    

Detailed description: 
      The silimarine is the main component of milk thistle (Sylibum marianum), a medicinal herb
      which, due to its attributed hepatoprotective properties, is widely used by HIV infected
      patients

      15 patients on stable antiretroviral therapy including darunavir/ritonavir 600/100 mg twice a
      day during four weeks will be enrolled. After their inclusion in the study, patients will
      receive treatment with silimarine (150 mg every 8 hours) from day 1 until two weeks later
      (day 14). On days 0 and 14, blood samples will be drawn immediately before and 1, 2, 4, 6, 8,
      10 and 12 hours after the administration of darunavir/ritonavir, and darunavir and ritonavir
      concentrations in plasma will be determined by high performance liquid chromatography using a
      validated method.
    

Intervention name(s): Silimarine
Intervention type(s): Drug
Intervention description(s): darunavir/ritonavir 600/100 mg + silimarine (150 mg every 8 hours)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Darunavir; Silimarine; interaction
Effect of Motorized Cryotherapy on Early Effusion, Swelling, and Pain After Anterior Cruciate Ligament Reconstruction
Condition: Cryotherapy Effect
Study type: Interventional

Summary: 
      To test the efficacy of motorized cryotherapy on early effusion, and pain after ACL
      reconstruction
    

Detailed description: 
      To test the efficacy of motorized cryotherapy on early effusion, and pain after ACL
      reconstruction compared to classical ice bagging
    

Intervention name(s): Motorized cryotherapy; Classical cryotherapy
Intervention type(s): Device; Device
Intervention description(s): application of motorized cryotherapy after ACL reconstruction; application of an ice bag
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Injection of Tenoxicam Versus Arthrocentesis Alone in the Treatment of Temporomandibular Joint Osteoarthritis
Condition: Arthrocentesis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the study is to examine the effectiveness of arthrocentesis plus tenoxicam
      injection and to compare it with arthrocentesis alone in patients with TMJ-OA.

      Thirty patients with TMJ-OA who were treated randomly with either arthrocentesis plus
      tenoxicam injection (TX group) or arthrocentesis alone (control group) were examined. Maximum
      mouth opening (MMO), visual analog scale (VAS) pain values, and joint sounds were the outcome
      variables, which were evaluated at pre-treatment and at 1, 4, 12, and 24 weeks after
      treatment.
    

Detailed description: 
      Temporomandibular joint osteoarthritis (TMJ-OA) is a very painful disease that disrupts the
      patient's comfort of life. Arthrocentesis alone or in combination with intraarticular
      injections is highly effective in the treatment of TMJ-OA. It reduces pain, increases mouth
      opening, and improves jaw movements. In intra-articular injections, hyaluronic acid,
      platelet-rich plasma, corticosteroids, and non-steroidal anti-inflammatory drugs (NSAIDS) are
      used. Tenoxicam is an NSAID that is used systemically or locally in joint diseases such as
      acute or chronic inflammatory rheumatoid arthritis and osteoarthritis. It has been reported
      that its long-lasting analgesic effect and anti-inflammatory effect are higher in
      intra-articular administration than in oral and intravenous administrations , to our
      knowledge, there has been no such study analysing the effectiveness of intra-articular
      application of tenoxicam in patients with TMJ-OA. The aim of the study is to examine the
      effectiveness of arthrocentesis plus tenoxicam injection and to compare it with
      arthrocentesis alone in patients with TMJ-OA.

      Thirty patients with TMJ-OA who were treated randomly with either arthrocentesis plus
      tenoxicam injection (TX group) or arthrocentesis alone (control group) were examined. Maximum
      mouth opening (MMO), visual analog scale (VAS) pain values, and joint sounds were the outcome
      variables, which were evaluated at pre-treatment and at 1, 4, 12, and 24 weeks after
      treatment.
    

Intervention name(s): Tenoxicam Injectable Product
Intervention type(s): Drug
Intervention description(s): After arthrocentesis procedure, 2-ml injection of tenoxicam (Oksamen-L, Mustafa Nevzat İlaç Sanayi, Istanbul, Turkey) to the temporomandibular joint
Other intervention name(s): Arthrocentesis
Intervention MeSH terms: Tenoxicam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
An Outpatient Study of Automated Blood Glucose Control With an Insulin-Only Bionic Pancreas
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This is an open-label, non-randomized, pilot study to determine the safety and feasibility of
      the insulin-only bionic pancreas.
    

Detailed description: 
      A total of 16 subjects, ages 18-45, will be enrolled in this crossover study. The study will
      consist of three 7-day study arms in the following order, one usual care arm, one bionic
      pancreas insulin only arm with a static glucose target, and one bionic pancreas insulin only
      arm with at dynamic glucose target.
    

Intervention name(s): Fixed set point; Variable set point
Intervention type(s): Device; Device
Intervention description(s): Fixed set point arm: A fixed setpoint will be used initially. Staff will observe glucose control over 2 days while subjects remain in a hotel environment, and then over 5 more days in the same subjects in an outpatient setting. The clinical staff will adjust this target up or down by 15 mg/dl based on their glycemic control in the hotel setting.; Variable set point arm: The setpoint will be variable over a 30 mg/dl range and glycemic control will be optimized based on the preceding 24-hour window.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: Single (Participant)
Primary purpose: Device Feasibility
Keywords: bionic pancreas; closed-loop control; artificial pancreas