bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Adherence Therapy on Medication Adherence in Patients With Schizophrenia Spectrum Disorder
Condition: Motivational Interviewing; Schizophrenia Spectrum Disorder; Medication Adherence
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      This study will explore the effect of Adherence Therapy(AT) on medication adherence in
      patients with schizophrenia spectrum disorder.
    

Detailed description: 
      A single-blind, randomized controlled trial with a repeated-measures, two parallel groups
      design will be conducted for 120 participants with schizophrenia spectrum in regional
      hospital in northern Taiwan. After baseline data collection finished, the blocked
      randomization will be employed to assign participants to two groups. The experimental group
      will participate in a eight session course of Adherence Therapy. The control group received
      routine care. The data will be collected for three times: before and after the intervention
      and 6 months after the intervention ends. A structured Questionnaire will use to collect data
      on the Medication Adherence Rating Scale, Schedule for the Assessment of Insight,
      Internalized Stigma of Mental Illness Scale, Self-Appraisal of Illness Questionnaire and
      Positive and Negative Syndrome Scale. Data analysis will employ Statistical Package for the
      Social Sciences 20.0 with Generalized estimating equations approach to examine effects of
      Adherence Therapy and routine care on medication adherence.
    

Intervention name(s): Adherence Therapy; control group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Motivational interviewing-based AT in this study was based on Gray et al.'s eight-session AT using the motivational interviewing technique (and principles of cognitive behavioral therapy).; The control group received routine care
Other intervention name(s): Motivational interviewing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Adherence Therapy; Insight; Medication Adherence; Motivational Interviewing; Schizophrenia Spectrum Disorder; Symptom severity; Randomized controlled trial
The Impact of a Polyphenol-Rich Supplement on Epigenetic and Cellular Markers of Immune Age
Condition: Immunity Disorders; Aging; Inflammation
MeSH terms: Immune System Diseases; Inflammation
Study type: Interventional

Summary: 
      This is a prospective, interventional, single-arm, open-label pilot study of 50 patients to
      evaluate the effect of a polyphenol-rich nutritional supplement on epigenetic and cellular
      markers of immune age.
    

Detailed description: 
      The objective of this study is to understand the impact of a polyphenol-rich supplement on
      measurements of epigenetic immune age and immune cell patterns germane to immune age over a
      90-day period. The primary objective of this trial is to assess the effects of the
      supplement, HTB Rejuvenate™, on immune age markers. The secondary objective of this trial is
      to assess the effects of the supplement, HTB Rejuvenate, on leukocyte immune profiles
      including T cell subsets and granulocytes.
    

Intervention name(s): HTB Rejuvenate
Intervention type(s): Dietary Supplement
Intervention description(s): 90 days of BID dosing of 2 capsules of HTB Rejuvenate
Intervention model: Single Group Assignment
Intervention model description: Prospective, interventional, single-arm, open-label pilot study
Masking: None (Open Label)
Primary purpose: Other
Keywords: Inflammaging; Immunosenescence; Polyphenol; Phytochemical; Phytonutrient; Tartary buckwheat; Fagopyrum tataricum
Differential Effect of High (200μg/kg/Min) Adenosine Dose on Fractional Flow Reserve in Patients Presenting Variation of FFR ≥0.05 During the Usual Dose of Adenosine Infusion (140μg/kg/Min).
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      Fractional flow reserve (FFR) is an established invasive method for assessing the
      physiological significance of coronary artery stenosis. However, in recent studies it has
      been observed and reported some degree of variation in the fraction of the coronary artery to
      the aortic pressure (Pd / Pa) during the infusion of standard adenosine dose (140mg/kg/min).
      The observed variation may be attributed to a failure to achieve maximal hyperemia with the
      normal dose. The administration of adenosine at a higher dose (200μg/kg /min) may influence
      coronary flow reserve (FFR) eliminating Pd / Pa variation during adenosine infusion.

      This is a prospective study which will be conducted in patients after coronary angiography
      with at least one angiographic lesion ≥50% in coronary vessels.

      Patients after written consent will undergo assessment of lesion severity with FFR under a
      three-minute infusion of adenosine 140mg/kg/min. In patients during steady state hyperaemia
      (determined by visual assessment) exhibiting variation in Pd / Pa ratio ≥ 0.05 (e.g.
      difference of max Pd/Pa minus min Pd/Pa) the examination will be repeated after 5 min with
      three-minute infusion under high dose adenosine (200mg/kg/min). The minimum ratio Pd/Pa per 3
      beats will be offline analyzed. The FFR during steady hyperemia state is defined as the
      average of the minimum ratio Pd / Pa per three beats.
    


Intervention name(s): Adenosine infusion at 200μg/Kg/min
Intervention type(s): Drug
Intervention description(s): Assessment of fractional flow reserve (FFR) under high adenosine intravenous infusion dose (200mg/kg/min)
Intervention MeSH terms: Adenosine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Coronary artery disease; Fractional floe reserve
Perioperative Goal Directed Therapy in Kidney Transplantation
Condition: Kidney Transplant; Complications
Study type: Observational

Summary: 
      In literature there is a huge amount of works demonstrating the direct correlation between
      volemic overload or fluid deficit and hypoperfusion and the increase in the rate of major
      postoperative complications in patients with high cardiovascular risk and chronic renal
      failure candidate to kidney transplantation from cadaver. It is also widely demonstrated that
      in certain populations with high surgical and post-operative complications risk, the adoption
      of targeted haemodynamic and clinical-therapeutic management protocols is indicated. The
      current trend is therefore to guarantee greater precision in the intraoperative management of
      patients undergoing kidney transplantation from cadaver by using a specific protocol that can
      be framed in the recent and innovative concept of Perioperative Gold Directed Therapy (PGDT),
      resulting from the adoption of an advanced minimally invasive hemodynamic monitoring
      technology with a special sensor called FloTrac (Edwards Lifesciences), already extensively
      tested in an extensive case series of high perioperative risk patients underwent to major
      abdominal surgery, major vascular surgery, major orthopedic surgery and cardio-thoracic
      surgery. In the present study there will be enrolled all patients who are candidates for
      kidney transplant from cadaver at the University Hospital "G. Rodolico" of Catania that meet
      the inclusion criteria of the study and will give their informed consent to participation.
      The enrolled patients will be monitored for a maximum period of 7 days from transplantation.
      As control group there will be considered an historical cohort of patients who underwent
      kidney transplantation from cadaver in 2015, in which a PGDT protocol was not used, but a
      common hemodynamic monitoring, based on parameters such as central venous pressure and / or
      invasive arterial pressure, was performed according to the international guidelines.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        33 consecutive patients candidates for kidney transplantation from cadaver that meet the
        eligibility criteria of the study and 33 patients who underwent kidney transplantation in
        2015
      
Keywords: Perioperative Goal Directed Therapy; Minimally invasive hemodynamic monitoring; Kidney transplantation
Efficacy of Baricitinib In Treatment of Delayed-Type Hypersensitivity Versus Irritant Skin Reactions in Healthy Adult Male Subjects
Condition: Allergic Contact Dermatitis
MeSH terms: Dermatitis; Dermatitis, Contact; Dermatitis, Allergic Contact; Hypersensitivity; Hypersensitivity, Delayed
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The treatment of allergic contact dermatitis (ACD) can be unsatisfactory, and that other skin
      diseases such as atopic dermatitis have an increased likelihood of ACD, improved systemic
      treatments are needed.

      This research study explores the effectiveness of Baricitinib in treating Delayed-Type
      Hypersensitivity (allergic) versus Irritant Skin reactions. Subjects for this study need to
      be healthy males between the ages of 18 and 40. This study will evaluate this by injecting
      antigens as well as applying them on top of the skin to the forearm then measure the effects
      of Baricitinib by skin and blood testing.
    


Intervention name(s): Baricitinib; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Baricitinib 2 mg; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Phase II Study of Abraxane Gemcitabine Combination in Patients With Metastatic Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and toxicity of Abraxane combined with
      Gemcitabine in the patients with metastatic breast cancer.
    

Detailed description: 
      This study is to investigate the efficacy and toxicity of Abraxane combined with Gemcitabine
      in the patients with metastatic breast cancer.
    

Intervention name(s): Abraxane and Gemcitabine
Intervention type(s): Drug
Intervention description(s): ABX (Abraxane) 125 mg/m2，intravenous infusion，30min，day 1, 8, 15
GEM (Gemcitabine) 800 mg/m2，intravenous infusion，30min，day 1, 8, 15
Other intervention name(s): Combined Chemotherapy
Intervention MeSH terms: Gemcitabine; Albumin-Bound Paclitaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Docetaxel, Capecitabine and Oxaliplatin in Advanced Stomach Cancer
Condition: Stomach Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Considering synergism between docetaxel (D), capecitabine (X), and oxaliplatin (O) and
      favourable toxicity profile of oxaliplatin over cisplatin, it is to be expected that
      combination of docetaxel, capecitabine, and oxaliplatin (DXO) will be more effective than
      other regimens and feasible in advanced gastric cancer. DXO regimen can be also easily
      administered on out-patient setting. However, so far, DXO combination has not been tried in
      advanced gastric cancer. The investigators will determine maximum tolerated dose of DXO
      regimen in this phase I study.
    


Intervention name(s): Docetaxel, Capecitabine and Oxaliplatin
Intervention type(s): Drug
Intervention MeSH terms: Docetaxel; Capecitabine; Oxaliplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: To determine maximal tolerated dose of DXO regimen
Asymmetrical Recovery of Cone Outer Segment Tips and Foveal Displacement After Macular Hole Surgery
Condition: Macular Hole
MeSH terms: Retinal Perforations
Study type: Interventional

Summary: 
      Evaluation of asymmetry in recovery of cone outer segment tips and foveal displacement after
      macular hole surgery
    


Intervention name(s): Vitrectomy
Intervention type(s): Procedure
Intervention model: Single Group Assignment
Primary purpose: Treatment
Keywords: cone outer segment tips line, foveal displacement
A Study to Investigate the Effect of JNJ-42847922 on Polysomnography Measures in Patients With Major Depressive Disorder With Insomnia Who Are Stably Treated With Antidepressants
Condition: Depressive Disorder, Major
MeSH terms: Sleep Initiation and Maintenance Disorders; Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate effect of JNJ-42847922 on sleep latency (latency to
      persistent sleep) in participants with major depressive disorder who are stably treated with
      selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor who suffer
      from insomnia (inability to fall asleep).
    

Detailed description: 
      This is a double-blind (neither physician nor participants knows the treatment that the
      participant receives), placebo-controlled (placebo is compared with the study medication to
      test whether the study medication has a real effect in clinical study), randomized (the study
      medication is assigned by chance) 4-way crossover (method used to switch participants to 4
      different arms in a clinical study), and a single dose study. This study will consist of a
      screening phase (between 28 to 2 days prior to the study medication), a treatment phase of 4
      double blind study periods (2 days), and a follow-up phase (within 7 to 14 days after last
      dose of the study medication). Approximately 20 participants with major depressive disorder
      will participate in this study. Participants will be randomly assigned to 1 of 4 cohorts
      (groups) (Cohorts A, B, C, and D) to receive JNJ-42847922 (10 mg, 20 mg, and 40 mg) and
      placebo. Each cohort consists of 4 treatment periods (Periods 1, 2, 3, and 4). Safety will be
      evaluated by the assessment vital signs, 12-lead electrocardiogram, clinical laboratory
      testing, physical examination, and neurological examination. The total duration of study
      participation for a participant will be approximately 9 to 10 weeks.
    

Intervention name(s): JNJ-42847922; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Participants will receive suspension of JNJ-42847922 (10 mg, 20 mg, and 40 mg) orally on Day 1 of the appropriate treatment periods.; Participants will receive placebo orally on Day 1 of the appropriate treatment periods.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depressive Disorder, Major; Major Depressive Disorder; Insomnia; JNJ-42847922; Placebo
Comparison of Ultrasonographic and Anthropometric Measurements in Difficult Airway Evaluation
Condition: Difficult Airway Intubation
Study type: Observational

Summary: 
      In this study, anthropometric measurements (clinical measurements) will be applied in all
      patient groups; expected (to be difficult to provide airway patency as a result of detailed
      history, physical examination and evaluation tests performed by an experienced
      anesthesiologist), and unexpected (although it was not predicted that a difficulty was
      encountered). And ultrasounographic measurements will be applied in all patients. The aim of
      this study is to evaluate the predictive accuracy of ultrasonographic measurements.
    

Detailed description: 
      In the preoperative period, the following clinical tests will be performed before the patient
      arrives in the operating room and when the patient arrives, the measurements will be made by
      ultrasonography.

        1. Mallampati classification

        2. Determination of mouth opening (interinsizer distance)

        3. Thyromental distance

        4. Sternomental distance

      Preoperative evaluation of the patients and clinical results of the airway tests (mentioned
      above) will be recorded. The cervical soft tissue thickness will be measured and recorded at
      3 levels (thyrohyoid membrane, vocal cord, hyoid bone) with the help of ultrasonography
      (mentioned above). In addition, since all patients will be under general anesthesia,
      laryngoscopic images (laryngoscopic evaluation according to Cormack Lehane classification)
      routinely recorded on the anesthesia follow-up sheet will be recorded.
    

Intervention name(s): ultrasounography
Intervention type(s): Device
Intervention description(s): in preoperative period, airway ultrasounagraphy for all patients will be made
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        ASA 1-2-3, 18-75 aged, patients undergoing general anesthesia
Sex Differences in Gene Expression in Human Adipose Tissue
Condition: Healthy; Obesity
Study type: Observational

Summary: 
      This project was created to assess sex differences in adipose tissue gene expression in
      different locations in the body. The primary objectives are to understand:

        1. The mechanisms of differential body fat distribution in men and women

        2. How body fat distribution is affected by reproductive hormones

        3. The mechanisms linking fat distribution to health risks such as diabetes
    


Intervention name(s): Adipose Biopsy; Blood sample; CT Scan; DEXA
Intervention type(s): Procedure; Procedure; Radiation; Radiation
Intervention description(s): Adipose tissue will be sampled from the abdomen and buttock; Blood will be sampled from an IV line; Single image at the level of the liver; Whole body scan
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        General Population
      
Biospecimen description: 
      Blood, Fat tissue from abdomen and buttock
    
Keywords: adipose; lean; obese; overweight; healthy
Low Load Resistance Exercises With Blood Flow Restriction Versus High Load Resistance Exercises
Condition: Athletes
Study type: Interventional

Summary: 
      Practical blood flow restriction (PBFR) is a new technique of reducing the venous return
      using a band with a pressure that is applied using a perceived pressure scale. The studies
      that investigate the acute effect of using PBFR and regular high intensity exercises on the
      level of growth hormone (GH) and blood lactate (BL) after lower extremity training in
      collegiate athletes are scarce.
    

Detailed description: 
      Practical blood flow restriction (PBFR) is a new technique of reducing the venous return
      using a band with a pressure that is applied using a perceived pressure scale. The studies
      that investigate the acute effect of using PBFR and regular high intensity exercises on the
      level of growth hormone (GH) and blood lactate (BL) after lower extremity training in
      collegiate athletes are scarce. Therefore, this study aimed to investigate the acute effect
      of a single session low load resistance exercises with PBFR compared to a high load
      resistance exercises without PBFR on the levels of GH and BL. A convenience sample of
      collegiate athletes were allocated to either an experimental group that performed low
      resistance exercises with PBFR or a control group that performed high resistance exercises
      without PBFR. The levels of GH and BL were examined in 3 time points: pre-training, immediate
      post-training, and 15 minutes post-training for both groups. Analysis of Variance (ANOVA) was
      used to assess the main and interaction effects of the groups.
    

Intervention name(s): Resistance exercise
Intervention type(s): Other
Intervention description(s): The training session included leg curl and leg extension exercises with 4 sets each. Participants started with leg extension exercise for 4 sets with a 30-second rest periods between the sets. Then, participants took a rest for 60 seconds. Afterward, participants performed leg curl exercise for 4 sets with a 30-second rest periods between the sets. Exercises in each set were performed continuously (uninterrupted) with a speed of 2 seconds for each repetition and a medium exercise performance speed.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: blood flow restriction; Growth hormone; Blood lactate
A Study to Evaluate the Safety and Efficacy of Rituximab in Adults With Primary Progressive Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a Phase II/III, randomized, double-blind, parallel group, placebo controlled,
      multicenter study to evaluate the safety and efficacy of rituximab in adults with PPMS. The
      study will enroll approximately 435 subjects at up to 60 sites in the United States and
      Canada.
    


Intervention name(s): placebo; rituximab
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous repeating dose; Intravenous repeating dose
Intervention MeSH terms: Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: PPMS; Primary progressive MS; Primary progressive multiple sclerosis; Rituxan; MS
Dopamine Responsivity in Gamblers
Condition: Pathological Gambling
MeSH terms: Gambling
Study type: Interventional

Summary: 
      This study deals with how people decide between rewards of different value. The investigators
      want to understand how the brain's dopamine system impacts this kind of decision making. The
      investigators will use a medication, tolcapone, which can temporarily affect the dopamine
      system.
    

Detailed description: 
      Tolcapone increases the effects of dopamine in the brain. Dopamine is a substance that is
      normally present in the brain. It may increase body movement and may also change a person's
      ability to process information. Tolcapone stops one's own naturally-released dopamine from
      being broken down as quickly. The investigators are interested in learning if tolcapone has
      positive effects on a person's decisions about rewards.
    

Intervention name(s): Tolcapone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tolcapone is in the medication class of catechol-O-methyltransferase (COMT) inhibitors; A placebo is a tablet or capsule that looks like the study medication (in this case, tolcapone) but does not contain any active ingredients
Other intervention name(s): Tasmar; Sugar pill
Intervention MeSH terms: Tolcapone
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This study is a single-group study in which subjects received both placebo and tolcapone in a randomized, double-blind, counterbalanced, within-subject design.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: decision making; impulsivity