bioihbjkbjnl/mcl2 huggingface dataset:
Feasibility Study of the Hemolung Respiratory Assist System (Germany)
Condition: Hypercapnic Respiratory Failure, COPD, ARDS
MeSH terms: Respiratory Insufficiency; Hypercapnia
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of the Hemolung Respiratory
      Assist System (RAS) in patients with hypercapnic respiratory failure.
    

Detailed description: 
      The objective of the feasibility study is to evaluate the safety and efficacy of the Hemolung
      RAS in patients with hypercapnic respiratory failure in five groups of patients:

      Group 1: COPD patients with an acute exacerbation and have a 50% likelihood of failure of
      noninvasive positive pressure ventilation (NIPPV) leading to intubation and mechanical
      ventilation

      Group 2: Patients with hypercapnic respiratory failure on invasive mechanical ventilation who
      have either:

        -  Failed two or more weaning attempts OR

        -  Failed one or more weaning attempts and do not wish to be invasively mechanically
           ventilated.

      Group 3: Patients with hypercapnic respiratory failure on noninvasive positive pressure
      ventilation who have failed two weaning attempts and do not wish to be invasively
      mechanically ventilated.

      Group 4: Patients with hypercapnic respiratory failure who in the view of the treating
      physician are declining on optimized non-invasive positive pressure ventilation OR
      demonstrate a complete intolerance of non-invasive positive pressure ventilation for any
      reason and invasive mechanical ventilation is considered undesirable by the treating
      physician.

      Group 5: Patients who are currently invasively mechanically ventilated and in the view of the
      treating physician would benefit from the application of protective lung ventilation, and in
      whom this cannot be achieved without significant worsening of respiratory failure.
    

Intervention name(s): Hemolung Respiratory Assist System
Intervention type(s): Device
Intervention description(s): Patients meeting the inclusion criteria will be placed on the Hemolung Respiratory Assist System. Patients will be weaned from non-invasive or invasive ventilation and then the Hemolung RAS. Hemolung support will be provided for up to 7 days. Follow-up exams will be performed every 15 days until hospital discharge or 30 days from completion of Hemolung therapy, whichever is later.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hypercapnic respiratory failure, COPD, ARDS
The Effects of Dietary Nitric Oxide and Anthocyanins on Anaerobic Exercise Performance
Condition: Exercise
Study type: Interventional

Summary: 
      The purpose of this graduate student research study is to investigate the effects of nitrate
      from beetroot powder with additional anthocyanins from tart cherry on exercise performance in
      healthy Loma Linda University students utilizing the Wingate Anaerobic test on stationary
      bike.
    

Detailed description: 
      A randomized controlled double-blind crossover study with a baseline and two interventions.
      On day 1 (baseline), all subjects will have a lactate fingerstick measurement before and
      after the Wingate protocol. A random subsample (1/3 of subjects) will have 10 milliliters (2
      teaspoon) of blood drawn for determination of serum allantoin. Subjects will then be equipped
      with a pulse oximeter and a heart rate monitor after which they will perform the Wingate
      Anaerobic test protocol. The protocol includes: 4 minutes of warm up, 3 seconds of warm up
      sprint with weights, 1-minute relaxed cycling, 2-minute rest, then 10 seconds cycling without
      weights. This will be followed by 30 seconds sprint with weights and end with 2 minutes of
      relaxed cycling. A post-activity blood draw will be performed for another 10 milliliters (2
      teaspoon) of blood from the same one-third of subjects previously sampled. After baseline
      data collection, subjects will undergo a 1-week washout (avoiding high antioxidant foods)
      after which they will be randomized to treatment groups. On day 9, subjects will begin
      supplementation with nitrate from beetroot powder with additional anthocyanins, or nitrate
      from beetroot powder with a placebo for 7 days. On day 15 the subject will again repeat the
      same procedures as day 1, followed by another week of washout. They will supplement again on
      day 23 and repeat the same procedure as the first intervention on day 29.
    

Intervention name(s): beetroot and anthocyanin; beetroot and placebo
Intervention type(s): Other; Other
Intervention description(s): Beetroot and anthocyanin will be taken for 7 days during the study two hours prior to eating.; Beetroot and placebo will be taken for 7 days during the study two hours prior to eating.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
A Safety and Effectiveness Study of TMC435 in Chronic, Genotype 1, Hepatitis C Patients Who Failed to Previous Standard Treatment
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the efficacy, safety and tolerability of different
      regimens of TMC435 with standard treatment compared to standard treatment alone in
      participants with chronic, genotype 1, hepatitis C virus (HCV) infection who has failed
      previous treatment with pegylated interferon (Peg-INF-alfa-2a) and ribavirin (RBV).
    

Detailed description: 
      The study is a randomized (study drug assigned by chance), double-blind (neither physician
      nor participant knows the name of the assigned drug), placebo-controlled Phase IIb trial with
      TMC435 in participants with chronic, genotype 1, hepatitis C virus (HCV) infection who have
      failed standard treatment with pegylated interferon (Peg-INF-alfa-2a) and ribavirin (RBV).
      The study will compare the efficacy, tolerability and safety of different regimens with
      TMC435 combined with standard treatment (Peg-INF-alfa-2a and RBV) versus standard treatment
      alone. The trial will consist of a screening period of maximum 6 weeks, a 48-week treatment
      period, and a 24-week follow-up period. Participants will be eligible to enroll in the trial
      if they failed to respond to a prior course of standard treatment or relapsed following
      standard treatment. Participants will be randomly assigned to receive TMC435 with standard
      treatment for 12 weeks followed by standard treatment (plus placebo) for 36 weeks, TMC435
      (100 mg or 150 mg once a day) with standard treatment for 24 weeks followed by standard
      treatment (plus placebo) for 24 weeks, TMC435 (100 mg or 150 mg once a day) with standard
      treatment for 48 weeks, or a placebo with standard treatment for 48 weeks.
    

Intervention name(s): TMC435; Placebo; Peg-IFN-alfa-2a (P); Ribavirin (R)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): One TMC435 100-mg capsule or two 75-mg capsules orally (by mouth) once daily for 12, 24, or 48 weeks.; One or 2 capsules of placebo identical in appearance to TMC435 taken orally once daily for 24, 36, or 48 weeks.; 180 micrograms taken as one 0.5 mL subcutaneous injection once weekly for 48 weeks.; 1000 or 1200 mg/day (5 or 6 tablets) taken orally as a twice daily regimen taken for 48 weeks.
Other intervention name(s): PEGASYS; COPEGUS
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a; Interferon alpha-2; Simeprevir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hepatitis C; Peginterferon alpha-2a; PegIFNalpha-2a; RBV; Ribavirin; Placebo; TMC435-TIDP16-C206; TMC435-C206; TMC435; HCV
A Retrospective, Multicenter, Controlled Clinical Trail: to Evaluate the Clinical Efficiency of Intracranial Aneurysm Assistive Software in the Morphological Measurement
Condition: Intracranial Aneurysm
MeSH terms: Intracranial Aneurysm; Aneurysm
Study type: Observational

Summary: 
      the goal of this clinical trail is to evaluate the clinical efficiency of intracranial
      aneurysm assistive software in the morphological measurement. The trail is designed as
      retrospective, multicenter, controlled clinical trail. Collecting probable cases images
      retrospectively according to inclusion criteria and exclusion criteria strictly. Controlling
      bias strictly, to make sure the measurement of intracranial aneurysm assistive software is
      evaluated reliably and precisely. In our trail, six physicions were recruited, containing
      three neuroradiologists, two radiologists and a residents. Software-assistant planning
      controls against no software-assisant planning，which aims to evaluate the improvement of
      morphological measurement efficiency of physicians.
    


Intervention name(s): Observational study
Intervention type(s): Other
Intervention description(s): Observational study
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Chinese
      
Keywords: Intracranial Aneurysm; Artificial Intelligence; Morphological measurement
Correlating In Vitro Fertilization Outcomes After Euploid Blastocyst Transfer With Sperm DNA Fragmentation
Condition: Male Infertility
MeSH terms: Infertility; Infertility, Male
Study type: Observational

Summary: 
      The purpose of this study is to determine if sperm DNA fragmentation is associated with in
      vitro fertilization (IVF) outcomes when euploid embryos are transferred.
    

Detailed description: 
      The purpose of this study is to determine if sperm DNA fragmentation is associated with in
      vitro fertilization (IVF) outcomes when euploid embryos are transferred. Euploid embryos are
      those that have a complete set of chromosomes (46, XX or 46, XY). Sperm DNA fragmentation
      refers to sperm DNA that is damaged or has an altered structure. The sperm chromatin
      structure assay (SCSA) is a method to evaluate sperm DNA Fragmentation.

      Couples will undergo a routine IVF cycle at Reproductive Medicine Associates of New Jersey.
      Semen specimens collected on the day of ICSI will undergo semen analysis as per routine. An
      aliquot of semen (0.5- 1mL) will be collected for subsequent evaluation of DNA fragmentation
      by the Sperm Chromatin Structure Assay (SCSA) testing at SCSA Diagnostics. All embryo
      biopsies will undergo CCS analysis in the genomics laboratory, Foundation for Assessment and
      Enhancement of Embryonic Competence.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Couples completing their first IVF/ICSI cycle at Reproductive Medicine Associates of New
        Jersey utilizing CCS (Comprehensive Chromosome Screening).
      
Biospecimen description: 
      An aliquot semen (0.5 - 1mL) will be collected and cryopreserved for analysis for DNA
      Fragmentation. Two tubes of serum (approximately 20 mL) will be collected from male partner
      via venipuncture.
    
Keywords: Male Infertility; Sperm DNA Fragmentation; Sperm Abnormality
Safety and Tolerability Study of NBI-98854 for the Treatment of Tardive Dyskinesia
Condition: Tardive Dyskinesia
MeSH terms: Dyskinesias; Tardive Dyskinesia
Study type: Interventional
Phase: Phase 3

Summary: 
      Phase 3, open-label, study to evaluate the safety and tolerability of NBI-98854 administered
      once daily (qd) for a total of 48 weeks of treatment. This study will enroll approximately
      150 medically stable male and female subjects with clinical diagnoses of schizophrenia or
      schizoaffective disorder with neuroleptic-induced TD or mood disorder with
      neuroleptic-induced TD.
    


Intervention name(s): NBI-98854
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence Study of Omeprazole Magnesium 20 mg DR Capsule Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose,
      crossover oral bioequivalence study of Omeprazole Magnesium 20 mg DR capsules of Dr. Reddy's
      Laboratories Limited, India and Prilosec OTCTM 20 mg (Omeprazole Magnesium DR Tablets)of
      Procter and Gamble, Cincinnati, Sweden in 38 healthy, adult, human subjects under fed
      conditions.
    

Detailed description: 
      This study used a crossover design consisting of 2 treatments, 2 sequences and 2 periods.
      Study Period-I and IT were separated by a washout period of 14 days. Use of a crossover
      design is appropriate since it enables comparison of treatments within the same subject using
      intrasubject variability thus improving the precision of treatment comparisons. Also use of
      14 days of washout period between successive drug administrations eliminates chances of
      residual drug being present at preceding period (i.e Period 1) to next period (i.e Period
      II).
    

Intervention name(s): Omeprazole
Intervention type(s): Drug
Intervention description(s): Omeprazole Magnesium DR 20 mg Capsules
Other intervention name(s): Prilosec 20 mg tablets
Intervention MeSH terms: Omeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; omeprazole; crossover
School Based Low-intensity Cognitive Behavioral Intervention for Anxious Youth
Condition: Anxiety
Study type: Interventional

Summary: 
      The study will evaluate two group CBT interventions delivered by school health nurses, in
      cooperation with community psychologist and mental health care personnel, to adolescents with
      mild to moderate levels of anxiety symptoms. The two interventions have different intensity
      (5 versus 10 group meetings). The two group interventions will be compared to a waitlist
      control group.
    

Detailed description: 
      Anxiety disorders are among the major mental health problems in children and adolescents,
      with regard to prevalence and long-term consequences. Cognitive behavioural therapy (CBT) has
      proven to be effective as treatment, early intervention and prevention of youth anxiety
      disorders. The majority of youth with anxiety problems, however, is not in contact with
      mental health services and do not receive effective help. This is due to shortage of
      personnel, resources and time among mental health-personal delivering treatment, as well as
      health services not being easily accessable for adolescents. School-based, low-intensity
      early intervention programs (indicated prevention) may improve access to effective treatment
      for youth with internalizing problems, and also promote more effective use of health
      services. The present study is a multi-site randomized controlled study with early
      intervention to be conducted within the primary health care service in three parts of Norway;
      including nine municipalities from west, east and south of Norway. A brief CBT program will
      be compared to a longer CBT program, and a wait-list control group. The effects will be
      evaluated with regard to decrease in youth internalizing symptoms. The CBT interventions are
      given to adolescents with mild to moderate levels of anxiety symptoms. Interventions are
      delivered by trained school-health nurses in collaboration with and/or supervised by
      experienced CBT therapists. The study involves researchers from three research environments
      in Norway, and collaboration with prominent international researchers from USA and
      Australia.The study has potential impact on how to deliver effective low-threshold
      interventions to anxious youth.
    

Intervention name(s): VÅG; CHILLED
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Low-intensity CBT intervention; Standard length CBT intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Anxiety; adolescents; school-based; low-intensity CBT
Pilot Study Assessing Insulin Pump Therapy in Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      16-week, open-label, multi-center pilot study. Insulin pump naïve subjects with type 2
      diabetes who are not achieving glycemic targets (screening A1C ≥ 7.0%) on an established
      regimen of either: 1) ≥ 2 OAs (Cohort A), 2) basal insulin ± OAs (Cohort B), or 3)
      basal-bolus insulin ± OAs (Cohort C) will initiate basal-bolus therapy with an insulin pump
      using a rapid-acting insulin analog.
    


Intervention name(s): Insulin Pump therapy
Intervention type(s): Device
Intervention description(s): Initiation of Insulin pump therapy in patients on >2 OAs (Cohort A), basal insulin ± OAs (Cohort B), or basal-bolus insulin ± OAs (Cohort C.
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Plasma and Intracellular Concentrations of Raltegravir and Etravirine Administered Once Daily
Condition: HIV-1 Infection; HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Hypothesis: the intracellular concentrations of raltegravir (RAL) and etravirine (ETV)
      administrated as 800 and 400 mg once a day, respectively, are similar to those obtained with
      the standard doses of 400 and 200 mg/12h, respectively.

      Objective: To analyze the plasma and intracellular concentrations of RAL and ETV
      administrated as 800 and 400 mg once daily respectively compared with standard doses of 400
      and 200 mg/12h, respectively, and if they support its once daily administration.
    

Detailed description: 
      Objective: To analyze the plasma and intracellular concentrations of RAL and ETV
      administrated as 800 and 400 mg once daily respectively compared with standard doses of 400
      and 200 mg/12h, respectively, and if they support its once daily administration.

      Method: Phase IV, prospective, open labelled clinical trial with a planned duration of 24
      weeks in which 16 patients from Hospitales Universitarios Virgen del Rocío will be enrolled.
      A 12 hours pharmacokinetic profile (immediately before and after 1, 2, 3, 4, 6, 8, 10 and 12
      h) will be obtained after a supervised drug intake while taking RAL or ETV bid.
      Afterwards,the patients will take RAL or ETV once a day for 7 - 10 days. Subsequently, a new
      pharmacokinetic profile (predose and after 1, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24 h after a
      supervised drug intake) will be obtained.
    

Intervention name(s): Raltegravir; Etravirine
Intervention type(s): Drug; Drug
Intervention description(s): Changing the dose of raltegravir from 400 mg bid to 800 mg qd; Changing the dose of etravirine from 200 mg bid to 400 mg qd
Intervention MeSH terms: Raltegravir Potassium; Etravirine
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Raltegravir; etravirine; pharmacokinetics; intracellular
Comparison of the Perioperative Effects of Dexmedetomidine and Ketamine Sedation in Septorhinoplasty Operations
Condition: Anesthesia; Intravenous Anesthetic Toxicity
Study type: Interventional

Summary: 
      This randomized double-blind study aimed to compare the effects of dexmedetomidine and
      ketamine on hemodynamic parameters, recovery criteria, and opioid consumption and advers
      effects in septorhinoplasty operations. Totally 63 patients were included.

      The groups were compared in terms of hemodynamic values, recovery times, postoperative
      agitation, sedation, activity, modified Aldrete and pain scores, side-effects and additional
      analgesia requirements at postoperative 24h.
    

Detailed description: 
      A total of 63 patients 18-55 years undergoing septorhinoplasty, who were graded as American
      Society of Anesthesiologists physical status were randomly allocated into three groups,
      receiving dexmedetomidine (n=21, Group D), ketamine (n=21, Group K) and saline solution
      (n=21, Group S). Anesthesia was induced with propofol, cisatracurium and fentanyl.
      Maintenance anesthesia was done with 2-2.5% sevoflurane mixture, 50-60% oxygen and N2O. The
      groups were compared in terms of hemodynamic values, recovery times, postoperative agitation,
      sedation, activity, modified Aldrete and pain scores, side-effects and additional analgesia
      requirements at postoperative 24h.
    

Intervention name(s): Dexmedetomidine; Ketamine; Saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): dexmedetomidine was administered as a gradual bolus of 1 µg/kg/10ml 10 min before induction of anesthesia and then as an infusion of 0.4 µg/kg per min (30 ml/h). In Group K, ketamine was administered as a 0.4 mg/kg/10ml IV bolus 10 min before induction of anesthesia and in the form of 10 µg/kg per min infusion after induction (30 ml/h).; In Group K, ketamine was administered as a 0.4 mg/kg/10ml IV bolus 10 min before induction of anesthesia and in the form of 10 µg/kg per min infusion after induction (30 ml/h).; Group S was given a bolus of saline solution in 10 ml volume 10 min before induction of anesthesia, followed by 30 mL/h serum saline infusion.
Other intervention name(s): Group D; Group K; Group S
Intervention MeSH terms: Dexmedetomidine; Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: First arm received dexmedetomidine
Second arm received ketamine
Third arm received saline solution.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Dexmedetomidine; Ketamine; Perioperative effects
Lifestyle Modification for Obesity-Related Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus; Overweight; Obesity
MeSH terms: Diabetes Mellitus; Obesity; Diabetes Mellitus, Type 2; Overweight
Study type: Interventional
Phase: Phase 4

Summary: 
      Dietary carbohydrate is the major determinant of postprandial glucose levels, and preliminary
      evidence suggests that low carbohydrate diets improve glycemic control when accompanied by
      weight loss. To determine if glycemic control can be improved by varying dietary carbohydrate
      during weight loss, we compared two weight loss diets with different carbohydrate levels for
      the treatment of obesity-related type 2 diabetes over 24 weeks in the outpatient setting.
    


Intervention name(s): Low carbohydrate, ketogenic diet; Low glycemic index, reduced calorie diet
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lifestyle modification; weight loss; hyperglycemia; hypoglycemic agents