bioihbjkbjnl/mcl2 huggingface dataset:
The MEDIPSA Clinical Trial
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Study type: Interventional

Summary: 
      The main purpose of this study is to validate the positive effect of "Omnibiotic Stress
      Repair" on patients with active psoriatic Arthritis.
    

Detailed description: 
      This is a single center, double blind (patients and investigators), Placebo controlled
      randomized trial.

      Consecutive patients with Psoriatic Arthritis (PsA) in moderate disease activity (Psoriatic
      Arthritis Disease Activity Score: PASDAS >3.2 - <5.4) on a stable treatment (no
      immunomodulatory treatment change in the last 3 months) with biological (bDMARDs) and/or
      synthetic disease modifying anti-rheumatic drugs (sDMARDs) and/or glucocorticoids will be
      included in the study. Clinical assessment will be scheduled at baseline, 12 weeks and 24
      weeks.
    

Intervention name(s): Omnibiotic Stress Repair (OBSR); Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): OBSR is given orally once daily (3g) for 3 months; Placebo is given orally once daily (3g) for 3 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: psoriatic arthritis; probiotics; microbiome
Families With Substance Use and Psychosis: A Pilot Study
Condition: Psychosis; Substance Use; Substance Use Disorders; Family; Tobacco Use; Nicotine Use Disorder; Cigarette Smoking; Cannabis; Marijuana; Alcohol Use Disorder; Alcohol; Schizophrenia; Schizoaffective Disorder; Bipolar Disorder; Mental Disorder
MeSH terms: Substance-Related Disorders; Alcoholism; Tobacco Use Disorder; Schizophrenia; Bipolar Disorder; Psychotic Disorders; Mental Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to develop and evaluate an intervention that adapts Community
      Reinforcement and Family Training (CRAFT) for families experiencing first episode psychosis
      and substance use delivered via telemedicine (video conferencing). The intervention aims to
      improve treatment engagement and reduce distress, and it will be delivered via telemedicine
      (CRAFT-FT). To assess feasibility of the intervention, family members will complete the
      sessions and provide feedback to refine the treatment manual. Data on client relatives with
      psychosis will be collected for preliminary assessment purposes. Client relatives will not
      complete the research study intervention.
    


Intervention name(s): CRAFT-FT
Intervention type(s): Behavioral
Intervention description(s): CRAFT-FT will be delivered via telemedicine. Topics include building motivation, self-care, communication, understanding patterns of behavior, positive reinforcement, and negative consequences. The intervention will be tailored to families of individuals experiencing psychosis and substance use who are enrolled in first episode psychosis outpatient services. Participants will be asked to completed assessments at pre-treatment, mid-treatment (approximately week 3), post-treatment, and a follow-up assessment approximately 3 month post-treatment.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Family; Substance Use Disorder; Psychosis
N-Acetyl-Cysteine (NAC) in Early Phase Schizophrenia Spectrum Psychosis
Condition: Schizophrenic Psychoses
MeSH terms: Schizophrenia; Psychotic Disorders; Mental Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators seek to examine the effect of add-on N-Acetyl-Cysteine (NAC) in the early
      phase of schizophrenia spectrum illness in collaboration with researchers Kim Do, PhD, and
      Philippe Conus, MD in Switzerland. Modifications of brain structure are thought to occur
      during the pre-illness phase and around the transition to psychosis. Therefore, studying new
      treatments that could target changes occurring during this period is of critical importance.

      Aims:

      Does add-on NAC treatment in early psychosis influence:

        -  positive and negative symptoms

        -  extrapyramidal side-effects of other medication

        -  plasma concentration of glutathione

        -  Mismatch Negativity, a physiological marker
    

Detailed description: 
      The study proposes that a glutathione deficit leading to an abnormal response to oxidative
      stress is a vulnerability factor, combined with other brain specific factors, in brain
      functioning of some individuals with schizophrenia (Do et al., 2010). N-acetyl-cysteine is
      hypothesized to cross the blood-brain barrier and increase glutathione in the brain.
    

Intervention name(s): n-acetylcysteine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM; Placebo tablets are placed in water or juice in the AM and PM
Other intervention name(s): PharmaNAC
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: schizophrenia; schizoaffective; schizophreniform; early schizophrenia spectrum psychosis
Laparoscopic Gastric Plication Operation for Patients With Severe or Morbid Obesity
Condition: Morbid Obesity
MeSH terms: Obesity; Obesity, Morbid
Study type: Interventional

Summary: 
      The purpose of this study is to collect data prospectively on the safety and efficacy of the
      Laparoscopic Gastric Plication operation for patients with Severe or Morbid Obesity.

      The 95% confidence interval for average percentage of weight loss and body mass index will be
      computed at 6 months, one year and then annually. Analysis of comorbid conditions changes,
      quality of life and adverse events will be performed. With 50 subjects in the study, limited
      power is expected and no formal hypothesis testing will be performed.
    

Detailed description: 
      The laparoscopic gastric plication (LGP) is a new restrictive bariatric surgical technique
      that has the potential to eliminate the complications associated with other restrictive
      procedures (i.e., gastric banding, sleeve gastrectomy) by creating a restriction without the
      use of an implant and without performing gastric resection. LGP is notably similar to a
      sleeve gastrectomy in that it generates a gastric tube by means of eliminating the greater
      curvature but does so without gastric resection.
    

Intervention name(s): Laparoscopic Gastric Plication
Intervention type(s): Procedure
Intervention description(s): The procedure is performed laparoscopic. The greater curvature of the stomach is separated from the greater omentum using a harmonic scalpel starting approximately 3-5 cm from the pylorus and ending at the angle of His. As needed, adhesions to the posterior surface of the stomach may be transected. At least two rows stitches will be placed laparoscopically about the greater curvature of the stomach starting at or near the angle of His and ending in the antrum. A calibration tube or endoscope will be used to maintain a lumen during the procedure, ensuring one exists after the procedure.
Other intervention name(s): Laparoscopic Greater Curvature Plication; Vertical Gastric Plication; Gastric Sleeve Plication
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Morbid Obesity; Bariatric Surgery; Laparoscopic Gastric Plication
Evaluation of S-600918 in Adults With Refractory Chronic Cough
Condition: Chronic Cough
MeSH terms: Cough
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to determine the optimal dose of S-600918 in patients
      with refractory chronic cough by evaluating the change from baseline in 24-hour cough
      frequency (coughs per hour) with S-600918 compared with placebo.
    


Intervention name(s): S-600918; Placebo to S-600918
Intervention type(s): Drug; Drug
Intervention description(s): Tablets for oral administration; Tablets for oral administration
Other intervention name(s): Sivopixant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: P2X3 receptor antagonist; Refractory chronic cough; S-600918
At Home Study of a Zone-Model Predictive Control (MPC) Controller and a Health Monitoring System (HMS) With the Diabetes Assistant (DiAs) System and Run-to-Run Adaptation
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      This clinical trial is a study to assess the performance of an automated glucose control
      system (Artificial Pancreas, AP) device in home settings for subjects with type 1 diabetes.
      Specifically, the investigators will test zone model predictive control AP that will be
      enhanced by run-to-run optimizations of basal rates (BR) and insulin to carbohydrate ratios
      (CR).
    

Detailed description: 
      This clinical trial is a study to assess the performance of an automated glucose control
      system (Artificial Pancreas, AP) device in home settings for subjects with type 1 diabetes.
      Specifically, the investigators will test zone model predictive control AP that will be
      enhanced by run-to-run optimizations of basal rates (BR) and insulin to carbohydrate ratios
      (CR). This protocol builds on the investigators previously validated Zone-MPC and Health
      Monitoring System (HMS) algorithms (ClinicalTrials.gov: NCT01929798) integrated into the
      Diabetes Assistant (DiAs) system (ClinicalTrials.gov: NCT02463682). The same AP system used
      in NCT02463682 will now be used with algorithmic adjustment of CR's prior to closed-loop
      initiation, and continued BR and CR algorithmic optimization during closed-loop use for a
      longer duration.

      The system will be evaluated on up to 12 subjects per site (n=36 subjects) for 15 weeks at 3
      different sites (William Sansum Diabetes Center, University of Virginia, and Mayo Clinic,
      Rochester, MN).
    

Intervention name(s): CGM and Insulin Pump; Closed-Loop Control System
Intervention type(s): Device; Device
Intervention description(s): Dexcom G4 Platinum CGM with Share AP Receiver Roche Accu-Chek insulin pump.; The devices that will be used in the Closed-Loop Control System include the following components:
DiAs - a smart-phone medical platform; Dexcom G4 Platinum connected to DiAs via Bluetooth CGM receiver; Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth; Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and Zone-MPC and HMS algorithms running on DiAs (MPC and HMS)
Intervention MeSH terms: Insulin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 1; Artificial Pancreas; Autoimmune Diseases; Diabetes Mellitus; Hyperglycemia; Hypoglycemia
Oral and Systemic aMMP-8 in Periodontal Disease
Condition: Periodontal Diseases; Periodontal Inflammation
MeSH terms: Periodontal Diseases; Inflammation
Study type: Observational

Summary: 
      Periodontal disease is an inflammatory process that can result in tooth loss and also is
      considered a modifying factor for systemic health. Matrix metalloproteinase (MMP)-8 is the
      major collagenase of periodontal tissue breakdown. The aim of the present study is to analyze
      active (aMMP-8) levels in gingival crevicular fluid (GCF), saliva and serum in the context of
      new criteria of gingivitis and stage 3 grade C periodontitis.
    


Intervention name(s): Biochemical analysis
Intervention type(s): Other
Intervention description(s): aMMP-8 is measured by immunofluorometric assay (IFMA).
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Healthy controls (n=23) includes volunteers with clinically healthy periodontium who had
        BOP < 10% and PD ≤ 3 mm, no sites with > 1 mm attachment loss, no radiographic sign of
        alveolar bone destruction and no history of periodontitis. Gingivitis patients (n=20) shows
        PD ≤ 3 mm with BOP > 50% in the entire mouth as well as no clinical attachment loss or
        alveolar bone loss. Periodontitis patients (Generalized Stage 3) have interdental CAL ≥ 5
        mm at least 2 non-adjacent teeth, PD ≥ 6 mm and radiographic bone loss affecting 30% of the
        teeth or more.They show also no more than 4 teeth loss due to periodontitis.
      
Keywords: periodontitis; gingivitis; matrix metalloproteinases
CARILLON Mitral Contour System® for Reducing Functional Mitral Regurgitation
Condition: Mitral Valve Insufficiency; Heart Failure
MeSH terms: Heart Failure; Mitral Valve Insufficiency
Study type: Interventional

Summary: 
      The objective of this prospective, multi-center, randomized, double-blind trial is to assess
      the safety and efficacy of the CARILLON Mitral Contour System in treating functional mitral
      regurgitation (FMR) associated with heart failure, compared to a randomized Control group
      which is medically managed according to heart failure guidelines.
    


Intervention name(s): CARILLON Mitral Contour System
Intervention type(s): Device
Intervention description(s): Percutaneous mitral valve repair
Other intervention name(s): CARILLON XE2
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: With crossover for sham procedure patients who are eligible at time of 12 month follow up.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Functional mitral regurgitation; Secondary mitral regurgitation; Percutaneous mitral repair
Study of Islet Transplantation in Type 1 Diabetic Kidney Transplant Recipients
Condition: Diabetes Mellitus, Type I
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of the study is to learn if islet transplantation is an effective treatment for
      Type 1 diabetes in people who have had a kidney transplant.

      The primary objectives of the study are:

      - To set up islet transplantation in patients who have had a kidney transplant and who are
      using an immunosuppressive regimen that works

      The Secondary objective of the study is:

        -  To find out if successful islet transplantation leads to improved metabolic control and
           reduced renal complication from diabetes
    

Detailed description: 
      Patients will receive (an) infusion(s) of in vitro cultured islets with the goal of achieving
      insulin independence. For the first islet transplant, patients will receive induction therapy
      with rabbit anti-thymocyte globulin (ATG, 5 doses) and will remain on their maintenance
      immunosuppression regimen already in place for their renal allograft. Induction therapy for
      subsequent transplants will be 2doses of basiliximab.

      All patients will receive Etanercept to promote engraftment.
    

Intervention name(s): Purified Pancreatic Islets; Etanercept
Intervention type(s): Biological; Drug
Intervention description(s): Islet after kidney transplant in patients with type I diabetes.; Given as induction for islet cell transplant
Intervention MeSH terms: Etanercept
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type I diabetes; Islet after Kidney Transplant; Islet transplantation
The Evaluation of the Safety and Effectiveness of ANIMERS Chiara LA and JUVÉDERM VOLUMA® for Aging Mid-Face
Condition: Dermal Filler; Hyaluronic Acid; Lidocaine; Aging Mid-Face
Study type: Interventional

Summary: 
      This study is to evaluate the safety and effectiveness for the correction of aging mid-face
      of treatment group compared with the active control group.
    


Intervention name(s): ANIMERS Chiara LA; JUVÉDERM VOLUMA®
Intervention type(s): Device; Device
Intervention description(s): 20mg/SciVision Biotech Inc.; 20mg/Allergan, Inc.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Study of the Absorption, Metabolism, and Excretion of [14C]-AMG 510 Following a Single Oral Dose in Healthy Male Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objectives of the study are: to characterize the primary route(s) of elimination
      of [14C]-AMG 510 and drug-related material, and estimate the overall recovery of radiolabeled
      material in healthy male participants after oral administration of [14C]-AMG 510, and to
      characterize the pharmacokinetic (PK) of total radioactivity and AMG 510 following a single
      oral dose of [14C]-AMG 510 in healthy male participants.
    


Intervention name(s): AMG 510
Intervention type(s): Drug
Intervention description(s): Single oral dose of AMG510.
Intervention MeSH terms: Sotorasib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy volunteers; AMG 510
A Study to Evaluate the Safety and Efficacy of EV06 Ophthalmic Solution in Improving Vision in Subjects With Presbyopia
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine whether EV06 Ophthalmic Solution is safe and
      effective in improving distance corrected near vision in people who have presbyopia.
    

Detailed description: 
      Study subjects who were eligible for enrollment and had provided written informed consent
      were randomized in a 2:1 ratio to use of either EV06 Ophthalmic Solution or Placebo
      Ophthalmic Solution. For the first 7 days of study product administration (Period 1: Days
      1-7), subjects applied 1 drop of their assigned study product to one eye twice per day. For
      the next 84 days (Period 2: Days 8 - 91), if there were no unanticipated and no significant
      adverse events observed in the treated eye, subjects applied 1 drop of their assigned study
      product to both eyes twice per day.
    

Intervention name(s): EV06 Ophthalmic Solution; Placebo Ophthalmic Solution
Intervention type(s): Drug; Drug
Other intervention name(s): Active treatment; Inactive control (vehicle)
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Presbyopia; Vision; UNR844
Regional Anesthesia of Cesarean Section
Condition: Anesthesia, Obestetric
Study type: Interventional

Summary: 
      Beta trace protein assay is an indicator of post-spinal CSF leak that predicts the degree of
      post-spinal headache.
    

Detailed description: 
      Beta trace protein is specific for CSF only and it is a quantitative analytic test.
    

Intervention name(s): spinal needle
Intervention type(s): Device
Intervention description(s): It is a spinal needle with 'QUINCKE' Bevel. It is inserted in the lumbar region at the inter-space L4-L5, L4-L3 ,or L3-L2 lumber spaces, while the patient is put in the sitting position then CSF sample is taken then 2.5 ml of a local anesthetic(0.5 ml of 25 ug fentanyl and 2 ml of 8 mg heavy bupivacaine) is given intrathecal then the needle is withdrawn.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Safety Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli)
Condition: Condylomata Acuminata; Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This phase I clinical study was designed to evaluate the safety of Recombinant Human
      Papillomavirus Vaccine (6,11,16,18,31,33,45,52,58 Type)(E.Coli)(hereafter called HPV
      vaccine), manufactured by Xiamen Innovax Biotech CO., LTD., in healthy adults aged 18-45
      years old.
    

Detailed description: 
      The study would have 2 stages. In the first stage, around 12 healthy adults aged 18-45 (male
      vs female,around 1:1)would receive 135μg/0.5ml of the HPV vaccine, the participants would be
      actively followed up for 7 days, if no vaccine related serious adverse events(SAE) occurred
      and the vaccine is well tolerated, another group of 12 healthy adults aged 18-45 (male vs
      female,around 1:1)would be enrolled and would receive 270μg/0.5ml of the HPV vaccine. The
      vaccine would be administered intramuscularly at day 0, month 1 and month 6. All the
      participants would be actively monitored for adverse reactions/events for 1 month after each
      injection. SAE during the trial were followed up. And blood, liver and kidney function
      changes will be monitored before and 2 days after the first and third vaccination. Serum
      samples from all the subjects would be collected on day 0 and month 7 to test immunogenicity
      as exploratory analysis.
    

Intervention name(s): HPV Vaccine,135μg/0.5ml; HPV Vaccine,270μg/1.0ml
Intervention type(s): Biological; Biological
Intervention description(s): HPV vaccine (135μg/0.5ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule; HPV vaccine (270μg/1.0ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: human papillomavirus vaccine
The Effect of Tracleer® on Male Fertility
Condition: Hypertension, Pulmonary
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of the study is to evaluate the effects of chronic TRACLEER® treatment on
      testicular function via semen analysis in male patients with primary pulmonary arterial
      hypertension (PAH).
    


Intervention name(s): bosentan
Intervention type(s): Drug
Intervention description(s): Oral bosentan tablets 62.5 mg twice daly for 4 weeks, then 125 mg twice daily for 20 weeks.
Other intervention name(s): Tracleer (R)
Intervention MeSH terms: Bosentan
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Saffety of Oral Immunotherapy to Pistachio
Condition: Allergy; Food Allergy
MeSH terms: Hypersensitivity; Food Hypersensitivity
Study type: Observational

Summary: 
      The objectives of this study are (i) to evaluate the efficacy of oral immunotherapy to
      pistachio by evaluating the daily oral tolerance of 2g pistachio, by evaluating the long-term
      tolerance of 15g pistachio (sustained unresponsiveness) and by decreasing pistachio-specific
      IgE, (ii) evaluating the efficacy of pistachio immunotherapy on cashew tolerance, (iii) and
      to evaluate the safety of pistachio immunotherapy.
    


Intervention name(s): Food allergy
Intervention type(s): Other
Intervention description(s): Oral immunotherapy to pistachio
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All patients meeting the inclusion criteria (between 10 and 50)