bioihbjkbjnl/mcl2 huggingface dataset:
Preventing Heart Disease in Underserved Patients
Condition: Hypertension; Diabetes Mellitus; Hyperlipidemia
MeSH terms: Heart Diseases; Hyperlipidemias
Study type: Interventional

Summary: 
      The study will evaluate the impact of an internet based telemedicine system on cardiovascular
      risk profile of underserved patient populations. It is our hypothesis that a treatment plan
      and frequent communication via an internet based Telemedicine system will improve the
      cardiovascular risk profile of underserved patient populations at increased risk for
      cardiovascular disease. Our primary endpoint is a reduction over one year in the 10-year CVD
      risk score (ATP III risk model).
    

Detailed description: 
      The Insight Telehealth system (ITSMyHealthfile) is a disease-managment interactive health
      care delivery system. Patients access the system through a special Web site using a password.
      The system prompts the patient to enter their weight, blood pressure and heart rate and there
      is a text box available for unstructed comments.

      Patients will be randomized to either the telemedicine group or usual care group (controls).
      Individuals in the telemedicine group will be asked to transmit their health status weekly.
      Both groups will be followed for one year with quarterly visits.

      Patients of either sex, of any ethnic background or race, between 22 and 85years of age, who
      have a 10% or greater 10-year risk of CVD based on the Framingham risk score, and risk
      factors that if properly treated would reduced the risk by 5% or greater will be eligible for
      the study.

      Additional criteria

        -  literate

        -  telephone access

        -  ablility to utilize the Internet and telemedicine system (after training) Primary
           Outcome Reduction in Framingham risk index
    

Intervention name(s): telemedicine
Intervention type(s): Behavioral
Intervention description(s): Weekly transmission of health status (weight, activity, BP etc.) via the Internet with feeedback and reinforcement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: CVD risk; self monitoring; Internet; telemedicine
Clinical and Ultrasonographic Evaluation of the Effectiveness of Manual Lymphatic Drainage
Condition: Ultrasound Evaluation of the Effect of Manual Lymph Drainage; Effect of Manual Lymph Drainage on Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      Carpal tunnel syndrome (CTS) occurs as a result of compression of the median nerve under the
      transverse ligament along the carpal tunnel. The main cause of median nerve compression and
      carpal tunnel syndrome is the increase in volume in the carpal tunnel. The pressure exerted
      by the edema on the nerve should be brought under control in the early period. Edema that
      continues beyond the inflammatory process may contribute to the fibrotic phase, delaying
      healing and even causing complications such as pain and stiffness. Manual lymph drainage
      (MLD) is a special technique that includes light massage techniques and follows lymphatic
      pathways from proximal to distal and then from distal to proximal. On the basis of this
      concept; Stimulating the lymph system and increasing circulation, removing biochemical
      residues, reducing edema and pain, regulating sympathetic and parasympathetic system
      responses. It is known that MLD rapidly regulates lymphatic circulation by creating changes
      in interstitial fluid pressure, thus preventing even arthrofibrotic tissue that may occur
      after a traumatic situation, reducing edema, which is a predisposing factor for pain, and
      increasing mobility. The aim of this study is to determine the effectiveness of manual
      lymphatic drainage on clinical and ultrasonographic findings in carpal tunnel syndrome.
    


Intervention name(s): Manual lymphatic drainage; splint
Intervention type(s): Other; Device
Intervention description(s): Manual lymphatic drainage will be applied 5 days a week for about 15 minutes every day for 4 weeks.; In splint treatment, a volar-supported splint that keeps the wrist in a neutral position will be preferred and it will be recommended to both groups to be used only at night for 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: ultrasonographic evaluation; carpal tunnel syndrome; manual lymph drainage; edema; pain
Effect of Modified Stylet Angulation on the Intubation With GlideScope®
Condition: Cholecystitis; Stomach Cancer
MeSH terms: Stomach Neoplasms; Cholecystitis
Study type: Interventional

Summary: 
      The GlideScope® videolaryngoscope usually visualize glottis better than the conventional
      laryngoscope. Under the visualization of glottis by GlideScope®, the insertion of
      endotracheal tube, however, is challenging.

      The goal of this study was to determine which of two stylet (70° vs 90°) was better, as
      determined by time to intubation.
    


Intervention name(s): Glidescope guided intubation; GlideScope®
Intervention type(s): Procedure; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: intubation; stylet; videolaryngoscope
Anti-inflammatory Effect of Agaricus Blazei Murill in Inflammatory Bowel Disease (IBD)
Condition: Ulcerative Colitis; Crohn's Disease; Inflammatory Bowel Disease
MeSH terms: Crohn Disease; Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Examine whether daily oral ingestion of a immunomodulatory mushroom extract (AndoSanTM) in
      patients with ulcerative colitis (UC) and Crohn's disease (CD), experience clinical,
      biochemical and genetical improvement in their disease.

      A prospective randomised study comparing the mushroom extract with placebo.
    


Intervention name(s): AndoSan; Sugar Extract
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): AndoSan 30 ml x 2 for 21 days; Sham comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Cytokine levels in blood; Calprotectin in feces; Clinical symptom score.
Non-Positive Pressure Ventilation in Hypoxemic Patients
Condition: Acute Respiratory Failure
MeSH terms: Respiratory Insufficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      The study is aimed to assess the possible benefit of non-positive pressure mechanical support
      in front of conventional ventilation in patients admitted to the intensive care unit (ICU)
      because of pure hypoxemic respiratory failure.
    

Detailed description: 
      Pure hypoxemic patients admitted to intensive care unit in a teaching hospital have been
      randomized to be treated by conventional ventilatory support or non-positive mechanical
      ventilation support. Those patients who did not benefit from the experimental non-positive
      ventilatory support, were intubated and conventionally mechanically ventilated and discarded
      for analysis. The primary outcome was mortality rate in both groups, and secondary outcomes
      were length of stay, improvement of oxygenation, and reduced complications rates.
    

Intervention name(s): non positive pressure mechanical ventilatory support
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate the Pharmacokinetics, Safety, Tolerability of Repeated Dose Transdermal Rotigotine in Japanese and Caucasian Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the repeated dose Pharmacokinetics (PK) of transdermally delivered Rotigotine
      in Japanese and Caucasian female and male healthy subjects.
    


Intervention name(s): Rotigotine transdermal patch 1mg / 24 hours; Rotigotine transdermal patch 2 mg / 24 hours; Rotigotine transdermal patch 4 mg / 24 hours
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Rotigotine transdermal patch, repeated dose application over 24 hours; 1 mg / 24 hours; Rotigotine transdermal patch, repeated dose application over 24 hours; 2 mg / 24 hours; Rotigotine transdermal patch, repeated dose application over 24 hours; 4 mg / 24 hours
Other intervention name(s): Neupro; Neupro; Neupro
Intervention MeSH terms: Rotigotine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Rotigotine; Neupro; Japanese; Caucasian; Male; Female; Single dose; Pharmacokinetics
Immunogenicity of GSK Biologicals' Pandemic Influenza Vaccine (GSK1562902A) at Different Boosting Vaccination Schedules
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      Today, the leading contender for the next influenza pandemic is H5N1, a strain of avian virus
      found primarily in domestic and wild birds. Experts warn that the next influenza pandemic is
      imminent and could be severe. Prevention and control will depend on the rapid production and
      worldwide distribution of specific pandemic vaccines. Candidate 'pandemic-like' vaccines must
      be developed and tested in clinical trials to determine the best formulation and vaccination
      schedule.

      The purpose of this study is to assess the immune response of a candidate pandemic vaccine.
      The protocol posting deals with objectives & outcome measures of the secondary phase of this
      study. The objectives and outcome measures of the primary phase are presented in a separate
      protocol posting (NCT number = 00449670).
    


Intervention name(s): Pandemic influenza vaccine GSK1562902A
Intervention type(s): Biological
Intervention description(s): IM administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: immunogenicity; safety; GSK pandemic candidate vaccine
Mechanical Versus Alcohol Epithelial Debridement During Hotorefractive Keratectomy (PRK)
Condition: Refractive Error; Myopia
MeSH terms: Refractive Errors
Study type: Interventional
Phase: Phase 2

Summary: 
      In this prospective randomized clinical trial, confocal microscopy was used to evaluate the
      effect of mechanical versus alcohol-assisted epithelial debridement during photorefractive
      keratectomy (PRK)on corneal cellular elements. Sixty-six eyes of 33 subjects with a spherical
      equivalent less than -4.00 D who completed all follow-up visits were evaluated.
    


Intervention name(s): Mechanical debridement; Alcohol-assisted debridement
Intervention type(s): Procedure; Procedure
Intervention description(s): For mechanical epithelial removal, an 8.0-mm optical zone marker was applied to the cornea, centering over the entrance pupil. A hockey spatula was used to remove the central corneal epithelium.; For alcohol-assisted debridement, 20% ethyl-alcohol solution was instilled into an 8.0-mm well and kept in contact with epithelium for 20 seconds (being careful to avoid spillage over the areas not being treated). It then absorbed using a dry cellulose sponge followed by copious irrigation with BSS. The epithelium of the central cornea was removed using a blunt spatula.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: photorefractive keratectomy; PRK; alcohol-assisted debridement; mechanical debridement; confocal scan; confocal microscopy
A Rising Single Dose Study of the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics of MK-8892 (MK-8892-001)
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate safety, tolerability and effects on central diastolic blood pressure
      (cDBP) of MK-8892 given as single oral doses in healthy male participants (Panel A and B) and
      in male participants with mild-to-moderate hypertension (Panel C).
    

Detailed description: 
      Up to three planned panels of either 8 healthy participants (Panels A and B) or 8
      participants with mild to moderate hypertension (Panel C) will be enrolled. In Panels A and
      B, 8 participants will alternately receive single rising doses of MK-8892 or placebo. All
      doses will be administered in the fasted state, except Panel A, Period 5 in which a standard
      high-fat breakfast provided approximately 30 minutes prior to dosing.

      Panel A will begin first. At least 3 days will elapse before participants in the alternate
      panel (Panel B) will receive the next higher dose. In Panel C, 8 mild to moderate
      hypertensive male participants will receive single rising doses of MK-8892 or placebo. Panel
      C may begin after the first 4 periods of Panels A and B have completed dosing. For all
      panels, there will be at least 7 days washout between treatment periods for any given
      participant. Participants may only be enrolled in one panel of the study. Subsequent doses in
      any panel will be administered only after careful evaluation of safety, tolerability, and
      pharmacodynamic effects of a given dose. All participants in periods of all panels (with
      exception of 2.0 mg fasted/fed periods) will be randomly assigned to either study drug or
      placebo, i.e a participant could be assigned to receive study drug in one period and placebo
      in another. As per the protocol allocation plan, the same participants will receive 2.0 mg
      MK-8892 in a fasted and fed state.The 2.0 mg MK-8892 fed/fasted data will be utilized for
      pharmacokinetic comparison and only the 2.0 mg MK-8892 fasted data will utilized for the
      analysis of the pharmacodynamics endpoints.

      In addition, during any of the treatment periods if a participant demonstrates change in any
      one of the protocol-defined parameters lasting ≥1 hour, dose escalation in that participant
      will be halted and the participant may be withdrawn from the study or rechallenged at same
      dose or at a lower dose. Paricipants that meet criteria listed will be followed up until
      parameters no longer meet stopping rule criteria.
    

Intervention name(s): MK-8892; Placebo for MK-8892
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
INNA-051 Influenza Challenge Study
Condition: Influenza Prophylaxis
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2, randomized, double-blind, placebo-controlled study of INNA-051 in healthy
      adults, administered prior to administration of an influenza challenge virus. This study will
      evaluate 2 active dose levels of INNA-051 and placebo.
    

Detailed description: 
      Healthy participants will be administered 2 doses on INNA-051 intra-nasally and subsequently
      administered influenza virus as a challenge. Participants will be quarantined for 8 days.
      Study assessments will be performed during this period and they will monitored for symptoms
      of influenza infection.
    

Intervention name(s): INNA-051; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Liquid for intra-nasal administration; Liquid for intra-nasal administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Study to Assess Efficacy and Safety of XC221 in the Treatment of Influenza and Other Acute Respiratory Viral Infections
Condition: Acute Respiratory Viral Infections; Influenza
MeSH terms: Infections; Communicable Diseases; Influenza, Human; Virus Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      A multicenter double-blinded, randomized, placebo-controlled, parallel-group comparative
      Phase II clinical study to assess safety, tolerability, efficacy and optimal dose of XC221
      vs. placebo in patients with uncomplicated influenza or other ARVI during a 3-day treatment.

      The primary objective of the study is to demonstrate the difference in time before the onset
      of a sustained improvement in clinical symptoms according to the Modified Jackson Scale for
      ARVI and to determine the optimal dose of XC221 in the treatment of influenza and other ARVI.
    

Detailed description: 
      11 Russian centers were planned for participation in this study. The study consists of three
      periods: screening, treatment and follow-up.

      All eligible patients will be randomized into 3 groups (groups A, B and C) in a 1:1:1 ratio:

      Group A - XC221 100 mg daily (40 patients); Group B - XC221 200 mg daily (40 patients); Group
      C - Placebo (40 patients).

      During the treatment period (3 days), patients will receive XC221 / placebo daily on a
      background of standard symptomatic therapy. The follow-up period lasts for 11 days.
    

Intervention name(s): XC221 100 mg; XC221 200 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): once daily during 3 days.; once daily during 3 days.; once daily during 3 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Quince Seed Jelly and Breast Milk on Nipple Fissures
Condition: Primiparity; Postpartum
Study type: Interventional

Summary: 
      Background: In various experimental or clinical studies, it has been reported that the jelly
      made from the quince seed is effective in healing wounds (attributed to the antioxidants,
      which increased fibroblast activity and collagen production, facilitated the formation of
      granulation tissue and increased blood circulation) and has no side effects or
      contraindications.

      Purpose: To evaluates the effects of quince seed jelly and breast milk on nipple fissures.

      Methods: Randomised controlled experimental study.
    


Intervention name(s): Quince seed jelly group; Breast milk group; Control group
Intervention type(s): Other; Other; Other
Intervention description(s): Quince seed jelly, prepared by the researcher, was given to the mothers belonging to this group. Briefly, 3 g (2-3 pieces) of quince seeds are placed in 100 mL water and heated to boiling for 10 min. The prepared quince kernel was used for 3 days, immediately after cooling.14,15 On the 1st day postpartum, the researcher provided the mothers with practical training at the hospital, regarding the application of quince seed jelly to the nipple and areola and leaving it to dry. This training was repeated on the 3rd, 7th and 10th days, to ensure that the mothers followed it precisely. The training process was completed in 5-10 min, including questions and answers. Every 3-4 days (days 1, 3, 7 and 10), quince seed jelly prepared by the researcher was given to the mothers to continue applying, according to the procedure. The mothers were asked to apply it after every breastfeeding.; Mothers in this group received practical training, conducted by the researcher on the 1st day postpartum at the hospital, on applying a few drops of their breast milk to the nipples and areola after each breastfeeding and leaving it to dry. This training lasted 5-10 min. Breast milk application of mothers in this group was recorded on the 1st, 3rd, 7th and 10th days, by the researcher.; Any kind of application that the mothers in the control group did for the nipple fissures were recorded on the 1st, 3rd, 7th and 10th days postpartum, by the researcher
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: breast milk; early postpartum period; nipple fissures; midwifery; quince seed jelly
BG00012 Phase 2 Combination Study in Participants With Multiple Sclerosis
Condition: Relapsing-Remitting Multiple Sclerosis; Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the study is to evaluate the safety and tolerability of BG00012
      (dimethyl fumarate) administered in combination with interferon b (IFNß) or glatiramer
      acetate (GA) in participants with relapsing-remitting multiple sclerosis (RRMS).
    


Intervention name(s): dimethyl fumarate
Intervention type(s): Drug
Intervention description(s): Days 1-7: 120 mg three times a day (TID) for a total daily dose of 360 mg. Day 8 to Week 24: 240 mg TID for a total daily dose of 720 mg. Drug supplied as a capsule taken orally.
Other intervention name(s): Tecfidera; DMF; BG00012
Intervention MeSH terms: Dimethyl Fumarate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: BG00012; MS; RRMS
Comparison of PK After Administration of HCP1201 and Co-administration of Metformin SR 500mg and Rosuvastatin 10mg
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the pharmacokinetic characteristics between HCP1201 tablet 500/10 mg and
      co-administration of metformin 500 mg plus rosuvastatin 10 mg under fasted and fed state,
      respectively.
    

Detailed description: 
      An Open-label, Randomized, Single-dose Crossover Study to Compare the Pharmacokinetics After
      the Administration of HCP1201 Tablet 500/10 mg and Coadministration of Metformin SR 500 mg
      and Rosuvastatin 10 mg in Healthy Volunteers
    

Intervention name(s): HCP1201 500/10mg; Metformin SR 500mg; Rosuvastatin 10mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 500mg Metformin/10mg rosuvastatin fixed dose combination tablet orally in the morning on day1 or day8.; Co-administration of Metformin 500mg and Rosuvastatin 10mg orally in the morning on day1 or day8.; Co-administration of Metformin 500mg and Rosuvastatin 10mg orally in the morning on day1 or day8.
Other intervention name(s): Glucophage SR 500 mg; Crestor 10mg
Intervention MeSH terms: Metformin; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment