bioihbjkbjnl/mcl2 huggingface dataset:
A Clinical Trial Comparing Semaglutide in Healthy People Who Eat and Take the Medicine at Different Times
Condition: Healthy Volunteers Type 2 Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this trial is to find out whether taking semaglutide tablets at different times
      before and after eating has a similar effect compared to the recommended dosing time.
      Participants with type 2 diabetes are recommended to take semaglutide on an empty stomach,
      and they should not eat, drink, or take any oral medicine for at least 30 minutes after that.
      The trial will look at how different dosing times of semaglutide before and after eating a
      meal changes how much semaglutide participants get into their blood. Participants will get
      one semaglutide tablet daily for a total of 10 days. For the first 5 days participants will
      receive semaglutide tablets of 3 mg and for the next 5 days, participants will receive
      semaglutide tablets of 7 mg. From here onwards, semaglutide tablets will be referred to as
      the 'trial medicine', unless specifically mentioned. Participants will get the trial medicine
      (3 mg and 7 mg) under one of the 5 following dosing conditions. It will be decided by chance
      under which dosing condition participants will receive the trial medicine: A 2 hour fast
      before taking the trial medicine and 30 minutes fast after taking the trial medicine (Test
      arm A), A 4 hour fast before taking the trial medicine and 30 minutes fast after taking the
      trial medicine (Test arm B), A 6 hour fast before taking the trial medicine and 30 minutes
      fast after taking the trial medicine (Test arm C), A 2 hour fast before taking the trial
      medicine and an overnight fast (at least 6 hours fast) after taking the trial medicine (Test
      arm D), An overnight fast before taking the trial medicine and 30 minutes fast after taking
      the trial medicine (Reference arm E). Before each fasting period prior to receiving the trial
      medicine, participants will fast for 4 hours and then receive a standardised meal. The meal
      should be completed before the 2, 4 or 6 hours fasting is started. The trial will last for
      about 48 to 78 days (about 1.5 to 2.5 months). Participants will have 4 scheduled visits with
      the study doctor. At one of the visits, participants will be admitted to the trial unit and
      have to stay for 12 consecutive days. At all visits participants will meet with trial staff
      and will have blood tests along with other clinical checks and tests. Participants will be
      asked about their health, medical history, and habits. Women only: Women cannot take part if
      pregnant, breast-feeding, or planning to become pregnant during the trial period.
    


Intervention name(s): Oral Semaglutide
Intervention type(s): Drug
Intervention description(s): Participants will receive oral semaglutide tablet once daily for 10 days (3 mg for first 5 days and 7 mg for the next 5 days).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Docetaxel in Treating Older Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the
      growth of tumor cells, either by killing the cells or by stopping them from dividing.
      Chemotherapy drugs may have different effects in older patients.

      PURPOSE: This phase II trial is studying how well docetaxel works in treating older patients
      with locally advanced or metastatic non-small cell lung cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the quality of life of older patients with locally advanced or metastatic
           non-small cell lung cancer treated with docetaxel.

      Secondary

        -  Determine the response rate in patients treated with this drug.

        -  Determine the overall survival and progression-free survival of patients treated with
           this drug.

        -  Determine the mood status and autonomy of activity of patients treated with this drug.

        -  Determine the toxicity of this drug in these patients.

      OUTLINE: This is a multicenter study.

      Patients receive docetaxel IV twice in week 1. Treatment repeats every 2 weeks for up to 6
      courses in the absence of disease progression or unacceptable toxicity.

      Quality of life is assessed during study therapy in weeks 3-4, 7-8, and 11-12, and then at 6
      and 12 months after completion of study treatment.

      PROJECTED ACCRUAL: A total of 58 patients will be accrued for this study.
    

Intervention name(s): docetaxel; quality-of-life assessment
Intervention type(s): Drug; Procedure
Intervention MeSH terms: Docetaxel
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the lung; adenosquamous cell lung cancer; large cell lung cancer; squamous cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; recurrent non-small cell lung cancer
Comparison of PK After Administration of HCP1201 and Co-administration of Metformin SR 750mg and Rosuvastatin 20mg
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the pharmacokinetic characteristics between HCP1201 tablet 750/20 mg and
      co-administration of metformin 750 mg plus rosuvastatin 20 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 750/20 mg and Coadministration of Metformin SR 750 mg
      and Rosuvastatin 20 mg in Healthy Volunteers
    

Intervention name(s): HCP1201 750/20mg; Metformin SR 750mg; Rosuvastatin 20mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 750mg Metformin/20mg rosuvastatin fixed dose combination tablet orally in the morning on day1 or day8.; Co-administration of Metformin 750mg and Rosuvastatin 20mg orally in the morning on day1 or day8.; Co-administration of Metformin 750mg and Rosuvastatin 20mg orally in the morning on day1 or day8.
Other intervention name(s): Glucophage SR 750 mg; Crestor 20mg
Intervention MeSH terms: Metformin; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence Study of Coated Cesol Tablet Formulation Versus Biltricide
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the bioequivalence (BE) of new coated Cesol tablet
      (Test) versus Biltricide tablets (Comparator) in healthy male participants. Praziquantel
      (rac-PZQ) is the active ingredient for Cesol and Biltricide tablets.
    


Intervention name(s): Cesol (Test); Biltricide (Reference)
Intervention type(s): Drug; Drug
Intervention description(s): Participant will receive coated cesol tablet in sequence 1 (Day 1 and Day 15) and in sequence 2 (Day 8 and Day 22). A washout period of 7 days will be maintained between 4 treatment periods.; Participant will receive biltricide tablet in Sequence 1 (Day 8 and Day 22) and in sequence 2 (Day 1 and Day 15). A washout period of 7 days will be maintained between 4 treatment periods.
Other intervention name(s): Praziquantel; Praziquantel
Intervention MeSH terms: Praziquantel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bioavailability; Bioequivalence; Praziquantel; Cesol; Pharmacokinetics
Optimal Treatment for Spinal Cord Injury Associated With Cervical Canal Stenosis (OSCIS) Study
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Constriction, Pathologic; Wounds and Injuries
Study type: Interventional

Summary: 
      Controversy exists regarding the optimal management of acute traumatic cervical spinal cord
      injury (SCI), especially those without bone injury. Although surgical decompression is often
      performed in SCI patients with cervical canal stenosis, efficacy and timing of surgery
      continues to be a subject of intense debate. In this randomized controlled trial, the
      investigators compare two strategies: early surgery within 24 hours after admission and
      delayed surgery following at least 2 weeks of conservative treatment. The purpose of this
      study is to examine whether early surgery would result in greater improvement in motor
      function as compared with delayed surgery.
    


Intervention name(s): Early surgery; Delayed surgery
Intervention type(s): Procedure; Procedure
Intervention description(s): Surgery within 24 hours after admission; Surgery more than 2 weeks after injury
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Incomplete spinal cord injury; Cervical canal stenosis; Ossification of the posterior longitudinal ligament; Surgery; Decompression
MiSaver® Stem Cell Treatment for Heart Attack (Acute Myocardial Infarction)
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The objective of the present study is to establish the safety and efficacy of MiSaver® Stem
      Cell Treatment After a Heart Attack (Acute Myocardial Infarction)
    


Intervention name(s): MiSaver®
Intervention type(s): Biological
Intervention description(s): Intravenous administration of MiSaver® Stem Cell via peripheral vein access.
Other intervention name(s): stem cells
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Sequential dose escalating
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Heart Attack
Efficacy of Weekly Versus Daily Folic Acid Supplementation
Condition: Neural Tube Defects
MeSH terms: Neural Tube Defects; Spinal Dysraphism
Study type: Interventional

Summary: 
      Investigate the efficacy of weekly versus daily of folic acid supplementation on improving
      folate, vitamin B12,
    

Detailed description: 
      460 women of a rural community in the western highlands of Guatemala were recruited for
      participation in the double-blinded study led by Emory University and the Institute of
      Nutrition of Central America and Panama (INCAP). The women were randomly assigned one of 4
      vitamin treatments containing different levels of folic acid, Vitamin B12, iron and zinc. The
      treatments were as follows:

        1. weekly dose of folic acid at 5000ug, iron at 120 mg, zinc at 30mg, and B12 at 16.8 ug;

        2. weekly dose of folic acid at 2800ug, iron at 120mg, zinc at 0mg and B12 at 16.8ug;

        3. daily dose of folic acid at 400ug, iron at 60mg, zinc at 15mg, B12 at 2.4ug; and

        4. daily dose of folic acid at 200ug, iron at 50mg, zinc at 0mg, and B12 at 2.4ug.

      The women, aged 15-49, received the vitamins daily for 3 months. Anthropometric data and
      blood samples were taken at baseline and post-supplementation. The participants also
      completed a series of dietary interviews at baseline and post-intervention. No pregnant or
      lactating mothers were admitted into the study, nor severely anemic females. Blood samples
      were sent to the National Laboratory in Cuernavaca, Mexico, for analysis of serum folate
      levels.
    

Intervention name(s): multivitamin
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Preventing Childhood Antibiotic-associated Diarrhea by Prebiotics
Condition: Antibiotic-Associated Diarrhea
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      Prospective randomized double-blind study on the effect of prebiotics (inulin and
      fructo-oligosaccharides) in the prevention of antibiotic-associated diarrhea in children.
    

Detailed description: 
      Group will get either the product or placebo blindly throughout antibiotic treatment with
      additional 14 days.
    

Intervention name(s): Inulin and fructo-oligosaccharides.; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Supplement during antibiotic treatment+14 days.; Placebo is base powder of product with no oligosaccharides.
Other intervention name(s): Placebo is base powder of product with no oligosaccharides.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: prebiotics; Antibiotic-associated diarrhea
The Effects of T4 Versus T4/T3 on Psychological Distress After Total Thyroidectomy in Thyroid Cancer Patients
Condition: Thyroid Cancer; Distress; Depression; Anxiety; Fatigue
MeSH terms: Thyroid Neoplasms; Thyroid Diseases
Study type: Interventional

Summary: 
      The goal of this research is to compare the effects on psychological distress between T4 mono
      replacement group and T4/T3 combination replacement group after total thyroidectomy in
      thyroid cancer patients.

        1. Subjects:

             -  Psychologically distressed patients, such as depression, anxiety, and fatigue
                patient after total thyroidectomy with thyroid cancer are considered for
                participation. Screening of distress after total thyroidectomy is used HADS
                (Hospital Anxiety and Depression Scale) ≥ 8 for depression or anxiety, and MDASI-F
                (MD Anderson Symptom Inventory -Fatigue) ≥ 4 for fatigue.

        2. Randomization:

             -  Using the table of random sampling numbers, patients assign to T4 mono replacement
                group or T4/T3 combination replacement group.

        3. Evaluation for distress:

             -  Assessment will be made baseline, 4 weeks, 12 weeks and 24 weeks to investigate
                change of psychological distress (depression, anxiety, and fatigue). Level of
                distress after thyroidectomy will determine using Hospital Anxiety and Depression
                Scale (HADS), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI) for
                depression or anxiety, and Brief Fatigue Inventory (BFI) for fatigue.
    


Intervention name(s): Comthyroid; Synthroid
Intervention type(s): Drug; Drug
Intervention description(s): T4/T3 combination replacement; T4 mono replacement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison of the Efficacy of Fractional Er:YAG Laser for Acne Scar
Condition: Scar
MeSH terms: Cicatrix
Study type: Interventional

Summary: 
      Compare the efficacy of frational Er:YAG laser and that of bipolar frequency with diode laser
      treatment.
    

Detailed description: 
      In acne scar treatment, ablational laser would be superior to nonablative laser treatment.
      Frational Er:YAG laser treatment is a effective treatment plan for acne scar without severe
      adverse effects.
    

Intervention name(s): Er:YAG laser; Bipolar radiofrequency with diode laser
Intervention type(s): Procedure; Procedure
Intervention description(s): acne scar treatment using Er:YAG laser; acne scar treatment with bipolar radiofrequency combined with diode laser
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: acne scar; Laser therapy; wound healing
Total Intravenous Anesthesia and Inhalation Anesthesia
Condition: Postoperative Complications
MeSH terms: Respiratory Aspiration; Postoperative Complications
Study type: Observational

Summary: 
      The aim of us is to define the incidence of postoperative complications and recovery time in
      view of two anesthesia procedures.

      During the period between 01.01.2016 and 01.01.2017, totally 583 patients were included in
      the study, who had oral and maxillofacial surgeries. Anesthesia types were determined as
      total intravenous anesthesia (TIVA) and inhalation anesthesia (IA). Postoperative
      complications and recovery period were determined as tachycardia, bradycardia, hypertension,
      hypotension, recovery time, additional analgesia, nausea-vomiting. Both anesthesia procedures
      were compared in terms of these postoperative complications and recovery time.
    

Detailed description: 
      Totally American Society of Anesthesiologists (ASA) I-II, 18-60 ages, 583 patients who had
      had oral and maxillofacial operations for 30 minutes and over with TIVA and IA methods
      between 1st Jan, 2016 and 1st Jan, 2017. The ones who had insufficient data in their files
      and who were conscious / superficial sedation patients were excluded from the study. The
      patients were allocated to two groups as TIVA and IA. The total intravenous anesthesia group
      was named "Group TIVA" , and the volatile anesthesia group was named "Group IA".

      All the patients were opened vascular access after being taken into the operation room and
      were given anesthesia induction with 1 µg/kg fentanyl, 2 mg/kg propofol and 0,8 mg/kg
      rocuronium. The patients in Group IA were given 1-2% volume sevoflurane in 50% oxygen and 50%
      nitrous oxide during maintenance of anesthesia, while the patients in group TIVA were applied
      4-10 mg/kg/h propofol and 0.05-0.1 µg/kg fentanyl IV infusion with 50% oxygen and 50% air.
      While being woken up, each patient was given 0.3 mg/kg tenoxicam for analgesia and 0.2 mg/kg
      metoclopramide for nausea-vomiting prophylaxis in a routine way. Each patient was taken into
      recovery room after extubation and pulse rate, non-invasive blood pressure (NIBP) and oxygen
      saturation monitorization were done. Postoperative complication and vital finding tracks of
      each patient were done as usual and were recorded.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        ASA I-II, 18-60 ages patients who had had maxillofacial surgery for 30 minutes and over
        with TIVA and IA prosedures between 1st Jan, 2016 and 1st Jan, 2017 were our study
        population.
      
Keywords: Postoperative pain; Recovery period; Total intravenous anesthesia; Inhalation anesthesia
Role of Montelukast in Preventing Relapse in Childhood Idiopathic Nephrotic Syndrome
Condition: Nephrotic Syndrome
MeSH terms: Nephrotic Syndrome; Nephrosis; Syndrome
Study type: Interventional

Summary: 
      The investigators planned this research to elucidate if there is any efficacy of montelukast,
      a leukotriene receptor antagonist, in steroid sensitive childhood onset NS to help prevent
      relapses. This study was done to know the role of leukotriene receptor antagonist (LTRA)
      montelukast in preventing relapses in idiopathic childhood nephrotic syndrome (NS)
    

Detailed description: 
      A quasi-experimental study, done at Department of Pediatric Nephrology at the Children's
      Hospital & the Institute of Child Health, Multan. A total of 96 patients aged 1-10 years with
      steroid sensitive Idiopathic NS were assigned into two groups (48 patients in each group).
      The case group received montelukast 5mg daily at bed time while the control group was not
      given montelukast. Steroid treatment protocol was the same for the two groups as per
      institutional guidelines. Patients were monitored and followed for the response to treatment
      and evidence of relapse over the study period (minimum 12 months).
    

Intervention name(s): Montelukast
Intervention type(s): Drug
Intervention description(s): We wanted to know the role of leukotriene receptor antagonist (LTRA) montelukast in preventing relapses in idiopathic childhood nephrotic syndrome (NS)
Intervention MeSH terms: Montelukast
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: During the study period, adopting non-probability consecutive sampling method, patients were assigned into two groups; 53 in Case Group (given montelukast 5mg at bed time) and 53 in Control Group (given no montelukast).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Leukotriene antagonists; Nephrotic syndrome; Steroid
Sprint Snacks: The Effects of Prolonged Rest on Reduced Exertion Interval Training.
Condition: Cardiorespiratory Fitness
Study type: Interventional

Summary: 
      An adapted sprint interval training protocol involving 2-3 repeated 20-second sprints
      separated by 2-3 minutes rest (termed reduced exertion high- intensity interval training
      (REHIIT)) has been developed and has been shown to promote fitness benefits. This data shows
      how little exercise one may need to improve cardiorespiratory fitness, provided they are
      willing to work very hard. However, it is unknown whether the benefits of REHIIT are because
      of the "all-out" nature of the sprint efforts themselves or the pattern of completing sprints
      with relatively short (i.e., minutes) rest periods within a workout session.

      We are inquiring whether performing the same number and style of sprints with prolonged rest
      (i.e., 1-4 hours of rest in between sprints) is equally effective for improving aerobic
      fitness when compared to more traditional sprint interval training with 2-3 minutes of rest
      between sprints. Such information may make the effectiveness of sprint training more
      accessible and approachable for individuals unwilling or unable to plan a purposeful REHIIT
      exercise session into their day. If the rest interval could be prolonged then it may be
      possible to perform a few sprints as "exercise snacks" throughout the day without the need
      for a structured interval training session.
    


Intervention name(s): REHIIT; PR-REHIIT
Intervention type(s): Other; Other
Intervention description(s): REHIIT participants will come into the lab one time per training days (3 training days per week), each session lasting 10 minutes. Training sessions involve a two-minute warm-up, 3 X 20-second cycling sprints on an exercise bike with three minutes rest in between, and a one-minute cool-down.; PR-REHIIT participants will come into the lab on 3 separate occasions on the training days, which occur 3 days per week (i.e., 9 sessions per week). Each session lasts 3 minutes and 20 seconds and consists of a two-minute warm-up, a 20-second "all-out" sprint on a cycle ergometer, and a one-minute cool-down. There will be 1-4 hours of rest in between training sessions where participants are free to leave the lab and go about their normal day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: VO2max, maximal oxygen uptake
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 282 in Healthy Subjects and Subjects With Chronic Rhinosinusitis With Nasal Polyps
Condition: Chronic Rhinosinusitis With Nasal Polyps
MeSH terms: Sinusitis; Nasal Polyps; Polyps
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, double-blind, ascending multiple dose study in healthy volunteers and subjects
      with chronic rhinosinusitis with nasal polyps
    


Intervention name(s): AMG 282; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): AMG 282 is for the treatment of subjects with chronic rhinosinusitis with nasal polyps; Contains no active drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment