bioihbjkbjnl/mcl2 huggingface dataset:
OPERA Study: A Study of Two Dosing Regimens of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients.
Condition: Kidney Transplantation
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will compare the incidence of acute clinical or subclinical rejection between
      immunosuppression with CellCept at a starting dose of 3mg po daily with therapeutic drug
      monitoring and standard immunosuppression with CellCept and a fixed dose of 2g po daily, in
      kidney transplant recipients receiving induction by anti-IRL2, cyclosporine therapy, and
      early discontinuation of steroids. Patients will be randomized to one of the two treatment
      arms. The anticipated time on study treatment is 52 weeks.
    


Intervention name(s): mycophenolate mofetil; mycophenolate mofetil; anti-IL-2R; methylprednisolone; cyclosporine
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 3 g p.o. in divided doses q12h beginning on the day of renal transplant, Day 0, or the day before, Day -1, and continuing to Week 52, adapted to MPA by AUC on Weeks 2, 6, 12, 26, and 52 to obtain AUC0-12 of 50 milligrams (mg) multiplied by (*) height (h)/ liter(L).; 2 g p.o. in divided doses q12h beginning on the day of renal transplant, Day 0, or the day before, Day -1, and continuing to Week 52.; Induction by IL-2R was administered at Day 0 per standard of care at the site at the investigators discretion.; 500 mg intravenous (i.v.) was administered before or after the transplantation, and 0.5 mg/kg p.o. daily from Day 1 to Day 7.; 100-1500 nanograms (ng) per milliliter (mL) from Day 0 to Week 4, 800-1200 ng/mL from Week 4 to Week 12 and 500-800 ng/mL from Week 12 to Week 52
Other intervention name(s): CellCept; CellCept; Solumedrol
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Methylprednisolone; Methylprednisolone Hemisuccinate; Cyclosporins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Heart Biomarker Evaluation in Apnea Treatment
Condition: Cardiovascular Disease; Obstructive Sleep Apnea; Coronary Artery Disease
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Cardiovascular Diseases; Coronary Artery Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study examines the role of sleep apnea treatment in improving cardiovascular biomarkers.
    

Detailed description: 
      This is a Phase II randomized controlled trial that will evaluate the effects of supplemental
      nocturnal oxygen or Positive Airway Pressure (PAP) therapy, compared to optimal medical
      preventive therapy for Cardiovascular Disease (CVD) risk, on biomarkers of CVD risk in
      Obstructive Sleep Apnea (OSA) patients at high risk for CVD events. The study will focus on
      patients with moderate to severe OSA but only mild OSA symptoms.

      Eligible participants have a history or symptoms of heart disease AND have symptoms of sleep
      apnea or snoring. Participants will be contributing to medical knowledge about different
      options that can be used to improve heart disease in people with sleep apnea.
    

Intervention name(s): Healthy Lifestyles and Sleep Education plus PAP; Healthy Lifestyles and Sleep Education plus Supplemental Oxygen; Healthy Lifestyles and Sleep Education
Intervention type(s): Other; Other; Other
Intervention description(s): Participants randomized to this arm will be educated on PAP and then use PAP for 3 months. They will also receive optimized medical preventive therapy according to current American Heart Association guidelines for prevention of CVD and sleep guidelines.; Participants randomized to this arm will be educated on nocturnal supplemental oxygen and then use oxygen for 3 months. They also will receive optimized medical preventive therapy according to current American Heart Association guidelines for prevention of CVD and sleep guidelines.; Participants randomized to this arm will receive optimized medical preventive therapy according to current American Heart Association guidelines for prevention of CVD and sleep guidelines.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Lemon Verbena Extract Oxidative Stress and Muscle Damage
Condition: Muscle Injury; Muscle Soreness
MeSH terms: Myalgia
Study type: Interventional

Summary: 
      In the present study, investigators investigated whether supplementation with lemon verbena
      extract (LVE) could improve muscle damage and biochemical indicators after exhaustive
      exercise challenge. Based on maximum jump heights, 60 subjects (30 males and 30 females) were
      equally divided into a placebo group (0 mg/human/day) and an LVE supplement group (400
      mg/human/day), with gender-equal distribution. All subjects started supplementation 10 days
      before exhaustive exercise and continued it until all tests were completed. Before the
      intervention, after the exhaustive exercise, and on the following 3 days, the participants
      underwent 12-minute Cooper running/walking; blood collection; assessments of pain, muscle
      stiffness, maximum jump heights, and isometric maximum muscle strength; and anaerobic
      strength tests.
    


Intervention name(s): Lvemon verbena extract; maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Each capsule contained 200 mg of lemon verbena extract 2 capsules/day, 14 days; Each capsule contained 0 mg of lemon verbena extract 2 capsules/day, 14 days
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: DOMS,; Lemon verbena
A Study for Safety and Immunogenicity of BCG and AERAS-404 in HIV-Negative, TB-Negative, BCG-Naive Adults
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      70 subjects received BCG intradermally at Study Day -42, then at Study Day 0 were randomized
      to receive AERAS-404 50 mcg H4/500 nmol IC31 intramuscularly as a 3-dose (N=30) or 2-dose
      (N=30) regimen, or placebo (N=10). Subjects were vaccinated on Study Days 0, 56, and 231, and
      followed through Study Day 259.
    

Detailed description: 
      A total of 70 subjects who had received BCG at Study Day -42 were randomized on Study Day 0
      to receive 3 doses of placebo (N=10); 1 dose of placebo followed by 2 doses of AERAS-404
      (N=30; AERAS-404 2 dose regimen); or 3 doses of AERAS-404 (N=30; AERAS-404 3 dose regimen). A
      total of 69 (98.6%) subjects completed the study; the remaining subject, in the AERAS-404 2
      dose regimen, withdrew consent. All 70 subjects received the first and second vaccinations
      with placebo or AERAS-404 on Study Days 0 and 56, and 67 (95.7%) subjects received the third
      vaccination on Study Day 231. Three subjects did not receive the Study Day 231 vaccination (2
      in the AERAS-404 2 dose regimen, 1 due to withdrawal of consent and 1 due to pregnancy [the
      subject delivered a healthy boy without complications and was followed to study completion];
      and 1 in the AERAS-404 3 dose regimen, due to inability to discontinue daily isotretinoin
      started after the second vaccination [the subject was followed to study completion]).
    

Intervention name(s): BCG SSI; Placebo; AERAS-404
Intervention type(s): Biological; Biological; Biological
Intervention description(s): The dose volume administered for BCG was 0.1 mL, and the mode of administration was ID injection to the deltoid area.; This is the identical buffer solution in which H4:IC31 was formulated. The dose volume administered for Placebo was 0.5mL, and the mode of administration was an IM injection.; AERAS-404 vaccine was reconstituted on site by adding 0.2 mL H4 antigen solution to 0.8 mL IC31 adjuvant solution. The dose volume administered for AERAS-404 was 0.5mL, and the mode of administration was an IM injection.
Other intervention name(s): BCG Vaccine SSI Danish; bacillus Calmette-Guérin; Sterile buffered saline; H4:IC31
Intervention MeSH terms: BCG Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Change in Permeability of the Small Intestine After Treatment With Gluten
Condition: Gastrointestinal Disorders
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases
Study type: Interventional

Summary: 
      The overall hypothesis of this research study is that gluten intake alters intestinal barrier
      function in patients with Irritable Bowel Syndrome (IBS) diarrhea who also exhibit non-celiac
      gluten sensitivity (NCGS).
    

Detailed description: 
      The specific aim of this hypothesis-generating, pilot study is to randomize (like the flip of
      a coin) patients who have Non Celiac Gluten Sensitivity to a 4-week Gluten-containing diet
      (GCD) or to a Gluten free diet (GFD). The study will evaluate small bowel (SB) permeability
      functionally (2-sugar differential excretion), morphologically, using probe-based confocal
      laser to evaluate the small intestinal, as well as molecularly, using tight junction (TJ)
      messenger RNA (mRNA) expression in small bowel mucosa in response to the different diets.
    

Intervention name(s): Gluten Healthy; Placebo
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): Assessment of current diet and amount of gluten consumed will be determined by the dietitian and by means of a questionnaire at baseline. Subjects will have a 2-week run in period, in which they will continue or initiate a gluten free diet plan prepared by the dietitians. After the run-in period, participants will be randomized to either a gluten containing diet (GCD) or placebo (GFD) for 4 weeks.; A total of 24 patients with NCGS and 12 healthy controls will be recruited for this study. The 24 patients with NCGS will be randomized to receive one of two diets (GFD or GCD) in a 1:1 ratio
Assessment of current diet and amount of gluten consumed will be determined by the dietitian and by means of a questionnaire at baseline. Subjects will have a 2-week run in period, in which they will continue or initiate a gluten free diet plan prepared by the dietitians. After the run-in period, participants will be randomized to either a gluten containing diet (GCD) or placebo (GFD) for 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: IBS-diarrhea
Prospective, Randomized Study of the Impact of a Education Program for Patients Suffering From Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      According to the WHO, therapeutic education is intended to help patients acquire or maintain
      the skills they need to optimally manage living with a chronic disease. Low back pain is
      frequent and therapeutic education could be a promising option.

      The purpose of the study is to evaluate the impact of a therapeutic education program for
      patients suffering from low back pain.
    


Intervention name(s): Usual practice; Education program
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of PTPN22 C1858T Polymorphism in Children and Adolescents of Greek Origin With T1DM
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      The protein tyrosine phosphatase non-receptor type 22 (PTPN22) gene encodes a
      lymphoid-specific phosphatase (LYP) which is an important downregulatory factor of T cell
      activation. A PTPN22 polymorphism, C1858T, was found associated with T1DM in different
      Caucasian populations.

      In this observational case-control study, we aimed at confirming the role of PTPN22, C1858T
      polymorphism in T1DM predisposition in a Greek population.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children and adolescents of Greek origin who attended the Pediatric Diabetes Outpatient
        Clinic of 4th Department of Pediatrics of Medical School of Aristotle University of
        Thessaloniki for T1DM
      
Biospecimen description: 
      whole blood
Evaluation of HbA1c Levels and Ovarian Reserve and Type 1 Diabetes
Condition: Diabetes; Ovarian Failure
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      The human ovary is the target of an autoimmune attack, usually in organ or non-specific
      autoimmune disorders. Serum anti-Müllerian hormone (AMH) levels decrease early in menopause
      and menopause is seen in women with type 1 diabetes mellitus (DM1) at a young age. DM1 is
      aimed to show DM1 relationship with ovarian reserve based on the assumption that it will have
      lower AMH levels than controls, secondary to bad glycemic control and autoimmune attack in
      women.
    

Detailed description: 
      The study was designed prospectively. Ovarian functions in healthy volunteer women and
      patients who use DM1 diagnosed between 18-40 years old will be examined. Gonadotropin and AMH
      levels will be measured in follicular phase. To calculate the number of antral follicles
      (AFC) and ovarian volume, ultrasound will be looked at. Fasting and satiety blood glucose,
      HbA1c and C-peptide levels will be evaluated.
    

Intervention name(s): ovarian reserve
Intervention type(s): Diagnostic Test
Intervention description(s): To assess ovarian reserve in patients with Type 1 Diabetes Mellitus aged 18-40 years; ultrasonographic and laboratory parameters will be looked at.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        female patients between 18 and 40 years of age who had consent and had gynecological
        examination in our polyclinic; study group for patients with type 1 diabetes mellitus
      
Keywords: Antral follicle count; Anti müllerian hormone; Ovarian reserve; HbA1c; type 1 diabetes mellitus
Effects of a Ketogenic Diet on PCOS Outcomes
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional

Summary: 
      The aim of the study is to investigate the effects of a low calorie Mediterranean ketogenic
      diet on Polycystic Ovary Syndrome (PCOS) related outcomes.
    

Detailed description: 
      Fourteen overweight women with diagnosis of Polycystic Ovary Syndrome (PCOS) will undergo to
      a low calorie ketogenic Mediterranean diet with phyoextracts (KEMEPHY) for 12 week. Changes
      in body weight, body mass index (BMI), fat body mass (FBM), lean body mass (LBM), visceral
      adipose tissue (VAT), insulin, glucose, HOMA-IR, total cholesterol, low density lipoprotein
      (LDL), high density lipoprotein (HDL(, triglycerides (TGs), total and free testosterone,
      luteinizing hormone (LH), follicle stimulating hormone (FSH); dehydroepiandrosterone sulfate
      (DHEAs), estradiol, progesterone, sex hormone binding globulin (SHBG) and Ferriman Gallwey
      score will be evaluated.
    

Intervention name(s): Low calorie Mediterranean ketogenic diet with phytoextracts (KEMEPHY)
Intervention type(s): Other
Intervention description(s): The KEMEPHY diet (24-29) is a Mediterranean low calories ketogenic protocol (about 1000/1100 Kcal/day) with the use of some phytoextracts. During this protocol subjects are allowed to eat with no limits green leafy vegetables, cruciferous, zucchini, cucumbers and eggplants. The quantity of meat, eggs and fish was limited to once a day (120g of meat or 200g of fish or 1 egg) Table 1. Moreover, subjects daily consumed four food supplements and liquid herbal extracts. Food supplements are high proteins (19g/portion) and very low carbohydrate (3.5g/portion) formulas simulating the aspect and taste of common carbohydrate rich foods added with dry phytoextracts (30). Liquid herbal extracts were used for their draining /toning activity, useful to reduce some commonly reported light side effects of ketogenic diets as constipation, headache and halitosis.
Intervention model: Single Group Assignment
Intervention model description: Single arm study
Masking: None (Open Label)
Primary purpose: Treatment
A Trial of Single- and Multiple-doses of Aripiprazole in Adult Subjects With Schizophrenia or Bipolar I Disorder
Condition: Schizophrenia; Bipolar I Disorder
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to evaluate the pharmacokinetics (PK) of aripiprazole
      long-acting injectable (LAI) (420 mg) following deltoid or gluteal muscle administration in
      adult subjects with schizophrenia or bipolar I disorder.
    


Intervention name(s): Aripiprazole
Intervention type(s): Drug
Intervention description(s): Injection.
Other intervention name(s): (OPC-14597)
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Identification and Characterization of Bacteria in the Lungs of Children From 6 Months up to 6 Years Old, With Suspected Infection of the Lungs, in Spain.
Condition: Infections, Streptococcal
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections; Streptococcal Infections
Study type: Interventional

Summary: 
      The purpose of this study is to identify and characterise bacteria present in the lower
      airways of children with suspected chronic LRTIs and for whom bronchoalveolar lavage (BAL) is
      indicated by the clinician.
    


Intervention name(s): BAL fluid sampling; Nasopharyngeal swab sampling
Intervention type(s): Other; Other
Intervention description(s): Following routine BAL procedures at the hospital, collection of BAL fluid samples: at least 2 mL, at Day 0.; 1 swab, Day 0
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Chronic lower respiratory tract infection; Bonchoalveolar lavage; Nasopharyngeal swabs
A Study of LY3502970 in Japanese Participants With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to learn about the side effects of LY3502970 when given to
      Japanese participants with type 2 diabetes mellitus (T2DM). Blood tests will be performed to
      investigate how the body processes the study drug and how the study drug affects the body.
      For each participant, the study will last up to 24 weeks, inclusive of screening and will
      include 10 visits to the study center.
    


Intervention name(s): LY3502970; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Stimulant Effects on Brain Activity
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to investigate the effects of Methylphenidate on neural activity
      underlying inhibitory control and error monitoring in healthy adults. More specifically, the
      investigators aim to establish the baseline modulatory effect of Mehtlylphenidate on
      bottom-up and top-down aspects of these cognitive processes. This work will further our
      understanding of Attention Deficit Hyperactivity Disorder, Methylphenidate, and executive
      functioning.
    

Detailed description: 
      Methylphenidate (MPH) is the stimulant medication most commonly used in the treatment of
      attention deficit hyperactivity disorder (ADHD). MPH suppresses the reuptake of dopamine by
      blocking dopamine transporter, which is elevated in ADHD. However, the precise mechanism by
      which suppressed dopamine transporter activity relieves ADHD symptoms is not fully
      understood, partly because dopamine pathways are implicated in various processes that could
      play a role in the deficits of ADHD and other disorders. MPH-induced dopamine variation has
      extensive effects in the brain and influences various executive functions in unknown ways.

      Hypotheses:

      Inhibitory Control: The investigators predict that MPH should increase the top-down activity
      in right dorsolateral prefrontal cortex associated with response restraint during go-phases
      and bottom-up activity in caudate and right inferior frontal cortex associated with response
      cancellation during successful stop trials. A greater modulation of top-down or bottom-up
      activity would imply a selective effect of MPH on one pathway over the other.

      Error Processing: The investigators predict that MPH should increase the intensity of
      deactivation in the bottom-up dopamine pathway on error detection (substantia nigra, dorsal
      striatum and ACC), and increase the intensity of deactivation in the top-down pathway on
      post-error slowing (caudal OFC, ventral striatum, ventral substantia nigra). A greater
      modulation of top-down or bottom-up activity would imply a selective effect of MPH on one
      pathway over the other.
    

Intervention name(s): Methylphenidate; Placebo
Intervention type(s): Drug; Other
Intervention description(s): oral dose of methylphenidate. The MPH dose was selected based on previous studies in healthy adults (Mehta et al., 2000; Volkow, Fowler, Wang, Ding, & Gatley, 2002) and adults with ADHD (Aron et al., 2003). MPH reaches its peak plasma concentration 1-3 hours after an oral dose, and has a plasma half-life of 1.5-2.5 hours.; Lactose Placebo
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: Stop task; modulatory effect of MPH; bottom-up and top-down; cognitive processes
The Effect of Music Periodicity on Interictal Epileptiform Discharges
Condition: Rolandic Epilepsy; Benign Childhood Epilepsy With Centrotemporal Spikes; Epilepsy; Seizures
MeSH terms: Epilepsy; Seizures; Epilepsy, Rolandic
Study type: Interventional

Summary: 
      The purpose of this study is to determine if having children listen to the music of Wolfgang
      Amadeus Mozart (Sonata for Two Pianos in D Major, K. 448) will lessen the amount of spike
      discharges on his/her Electroencephalography (EEG). These spike discharges often occur during
      a 24 hour period in the EEG of a child with Benign Childhood Epilepsy with Centrotemporal
      Spikes (BCECTS), or Rolandic Epilepsy. Should there be a decrease in the amount of spike
      discharges after listening to Mozart's music, this information may lead to new understanding
      and possible treatments for epilepsy.
    


Intervention name(s): Mozart alternating with Beethoven; Beethoven alternating with Mozart
Intervention type(s): Other; Other
Intervention description(s): Study participants will listen to Mozart's Sonata for Two Pianos in D Major, K. 448 alternating with Beethoven's Fur Elise.; Study participants will listen to Beethoven's Fur Elise alternating with Mozart's Sonata for Two Pianos in D Major, K. 448.
Allocation: Randomized
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Rolandic Epilepsy; Benign Childhood Epilepsy with Centrotemporal Spikes (BCECTS); Epilepsy; Seizures; Music; Mozart; Beethoven