bioihbjkbjnl/mcl2 huggingface dataset:
Bexarotene Augmentation of Antipsychotic Treatment for Chronic Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      Background: Bexarotene (Targretin) is a synthetic retinoid mainly used for treatment of
      patients suffer from oncological or dermatological diseases. The present study is based on:
      evidence that retinoids are involved in neurodevelopment ("the retinoid dysregulation
      hypothesis"); an assumption that the combined effect of antipsychotic agents and bexarotene
      will have a beneficial effect on schizophrenia patients; and the positive findings from our
      pilot open-label clinical trial (ClinicalTrials.gov Identifier: NCT00141947). However,
      clinical efficacy of bexarotene should be investigated in a placebo-controlled trial.

      Methods: In a 6-week, randomized, double-blind placebo-controlled trial Targretin (75 mg/day)
      or placebo capsules will be added to the stable ongoing antipsychotic treatment of 90
      schizophrenia patients. Participants will be assessed at baseline and after 2, 4 and 6 weeks
      of treatment. A battery of research instruments will be used for assessment of
      psychopathology, side effects, general functioning and quality of life. In addition,
      cholesterol and triglyceride levels, liver and thyroid function tests and a blood cell count
      will be monitored at baseline and during the study
    

Detailed description: 
      Recruiting was beginning on November 2008
    

Intervention name(s): Bexarotene (Targretin LGD1069); bexarotene
Intervention type(s): Drug; Drug
Intervention description(s): 75 mg per day for 6 weeks; 75 mg/day 6 weeks
Intervention MeSH terms: Bexarotene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: retinoids; bexarotene; schizophrenia; PANSS; Positive and negative symptoms of schizophrenia
A Pharmacokinetic, Safety, and Pharmacodynamic Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome
Condition: Short Bowel Syndrome
MeSH terms: Short Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      This will be an open label, 4-cohort study. Non-randomized subjects will receive teduglutide
      in each of the 3 active cohorts. An attempt will be made to enroll additional subjects into
      an observational cohort who will receive standard of care. Three doses of teduglutide are to
      be investigated for 12 weeks. All subjects will be screened prior to the start of treatment
      (SOT) to establish baseline characteristics including safety, eligibility and nutritional
      support parameters.
    


Intervention name(s): teduglutide
Intervention type(s): Drug
Intervention description(s): Open label intervention. Each subject will be assigned to receive 0.0125, 0.025, or 0.05 mg/kg/day for the duration of the study
Intervention MeSH terms: Teduglutide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SBS; Pediatric SBS; Short Bowel Syndrome
Crossover Study of Neuropsychological Effects of Lacosamide and Carbamazepine Immediate Release in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this Phase 1 crossover study is to evaluate the neuropsychological
      effects of Lacosamide (LCM) compared to Carbamazepine Immediate Release (CBZ-IR) after
      administration in healthy subjects. Safety, tolerability, and pharmacokinetic data will also
      be collected.
    

Detailed description: 
      Approximately 50 subjects at multiple sites will crossover to receive both treatments
      (lacosamide [LCM]and carbamazepine immediate release [CBZ-IR]) in a randomized order during
      the 2 study treatment periods (Treatment Period 1 and Treatment Period 2).

      A Screening Visit will be conducted to evaluate subject eligibility for enrollment into the
      study. Eligible subjects will return up to 21 days after the Screening Visit and begin
      Treatment Period 1. During Visit 2, eligible subjects will be randomized to receive either
      LCM 300 mg/day or CBZ-IR 600 mg/day. Subjects will be treated with their first randomized
      Antiepileptic Drug (AED) for 6 weeks (Titration Period [21 days] and Maintenance Period [21
      days]). Subjects then complete a 28-day Taper/Washout Period, during which their first AED
      will be tapered over 4 days followed by a 24-day Washout Period, where subjects will receive
      no AED. Upon completion of the Taper/Washout Period, subjects will begin Treatment Period
      2.The procedures and assessments for Treatment Period 1 will be repeated for Treatment Period
      2 (with the same duration of treatment).
    

Intervention name(s): Lacosamide (LCM); Carbamazepine Immediate Release (CBZ-IR)
Intervention type(s): Drug; Drug
Intervention description(s): LCM 300 mg:
LCM 50 mg and LCM 100 mg white, film-coated oral tablets and Carbamazepine Immediate Release (CBZ-IR) matching placebo capsules.
Two times daily (morning and evening) during the first 2 weeks of each Titration Period and during the Taper Phases.
Three times daily (morning, mid-day, and evening) during last week of each Titration Period and 3-week Treatment Period; CBZ-IR 600 mg:
CBZ-IR 200 mg oral tablets over-encapsulated to double-blind capsules with an overfill.
LCM matching placebo tablets two times daily (morning and evening) during the first 2 weeks of each Titration Period and during the Taper Phases.
Three times daily (morning, mid-day, and evening) during last week of each Titration Period and 3-week Treatment Period.
Other intervention name(s): Vimpat; Tegretol IR
Intervention MeSH terms: Lacosamide; Carbamazepine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: Lacosamide; Vimpat; Cognition; Mental Processes; Adverse Effects
Opiate Free Multimodal Pain Pathway in Elective Foot and Ankle Surgery: A Prospective Study
Condition: Bunion of Unspecified Foot; Bunionette of Unspecified Foot; Hammertoe; Ankle Fractures; Achilles Tendon Surgery
MeSH terms: Hammer Toe Syndrome; Ankle Fractures
Study type: Observational

Summary: 
      Orthopedic surgeons frequently prescribe and over-prescribe narcotic pain medications during
      the postoperative period, despite the ongoing opioid crisis in the United States. While
      opioid-free multimodal pathways have shown promising results, there remains a lack of
      published literature evaluating opiate-free multimodal pain protocols for elective outpatient
      foot and ankle surgeries. This study aims to evaluate post-operative pain following the use
      of an opioid-free pain treatment plan for patients undergoing foot and ankle surgeries.
    

Detailed description: 
      Despite the presence and increased understanding of the opioid crisis in the United States,
      orthopedic surgeons frequently prescribe and over-prescribe narcotic pain medications during
      the postoperative period. In an effort to minimize narcotic analgesia and its potential side
      effects, opioid-free multimodal pathways have been developed in many orthopaedic
      sub-specialties with promising results. There have been early studies reporting the results
      of non-narcotic protocols during the intra-operative period. Likewise, there have been
      several studies reporting the results of inpatient non-narcotic pain protocols in select foot
      and ankle surgeries. However, there remains a lack of published literature evaluating
      opiate-free multimodal pain protocols for elective outpatient foot and ankle surgeries.
      Currently, our practice utilizes an opioid-free post-operative pain protocol for patients
      undergoing elective outpatient foot and ankle surgery. The goal of this study is to evaluate
      post-operative pain using this opioid-free multimodal pain protocol at days 1,3, and 8
      following elective outpatient foot and ankle surgery.
    

Intervention name(s): Acetominophen; Toradol; Meloxicam; Cyclobenzaprine; Lyrica
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 1,000 mg every 6 hours; 10 mg every 6 hours, days 0-3; 15 mg once daily, beginning post-op day 4; 10 mg every 8 hours; 75 mg every 12 hours
Other intervention name(s): Tylenol; Ketorolac; Mobic; Flexeril; Pregabalin
Intervention MeSH terms: Acetaminophen; Ketorolac; Ketorolac Tromethamine; Meloxicam; Pregabalin; Cyclobenzaprine
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Included in this study will be adult outpatient, elective, primary foot and ankle surgery
        that is not due to infection performed at Prisma Health Orthopedics.
Measurement of Anti-Androgen Response Using Fluorine-18 Fluorocholine PET/CT in Androgen-Insensitive Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine whether positron emission tomography / computed
      tomography (PET/CT) using fluorine-18 fluorocholine as an imaging agent can characterize
      regional responses to anti-androgen therapies in a manner that in the future aid in the
      customized planning of treatments for patients with androgen-insensitive prostate cancer.
    


Intervention name(s): IV administration of fluorine-18 fluorocholine followed by PET/CT imaging
Intervention type(s): Drug
Intervention description(s): Imaging intervention performed prior to and 30-75 days post a change in anti-androgen therapy.
Intervention MeSH terms: Fluorides
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Androgen insensitive prostate cancer
Effectiveness of a Online Training Program With a Clinical Procedure Standardized in Units of Nursing (CPSUN)
Condition: Infection Control; Preventive Measures
MeSH terms: Infections
Study type: Interventional

Summary: 
      This study evaluates if the implementation of an online platform with procedures and
      protocols, improve the knowledge of professionals and can have a health impact related to
      decreased contamination of blood cultures.
    

Detailed description: 
      This is a Quasi-experimental study, with parallel groups (experimental and control).

      The aim of this study is to evaluate the efficacy of an Online Learning Platform used by
      nurses to improve the results of a blood culture technique. The online learning tool is
      studied in two of four internal medicine units of a tertiary hospital in Madrid. These two
      units have similar characteristics of personnel, materials and structure. Both units are at a
      great distance, preventing a professional talk to each other.
    

Intervention name(s): Online training of a nursing technique
Intervention type(s): Procedure
Intervention description(s): The professionals with participant in the experimental arm receive an online training of a technique of extraction of blood culture and other arm the professionals no receive any training. They work as usual.
Other intervention name(s): Elsevier Clinical Skills
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: nursery care; nursery infection; online learning
Gentrix® Surgical Matrix for Soft Tissue Reinforcement in Ventral Hernia Repair
Condition: Ventral Hernia
MeSH terms: Hernia; Hernia, Ventral
Study type: Observational

Summary: 
      The purpose of this study is to collect additional safety data and demonstrate the
      performance of Integra Gentrix® Surgical Matrix for reinforcement of ventral hernia repairs.
    

Detailed description: 
      Retrospective data will be collected and assessed for early post-operative surgical site
      events and complications in the immediate post-operative period of 90 days.
    

Intervention name(s): Retrospective chart review
Intervention type(s): Device
Intervention description(s): The retrospective chart review will include the full consecutive series of patients between 22 years and 80 years old who underwent abdominal wall reconstruction for achart hernia with Integra Gentrix® Surgical Matrix during the time period between November 1, 2017, and present (90 days prior to the start of data collection).
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients between 22 years and 80 years old (inclusive) at time they underwent abdominal
        wall reconstruction utilizing Gentrix® Surgical Matrix as a reinforcement graft during the
        time period between November 1, 2017, and present (90 days prior to the start of the data
        collection).
KUL0401: An Open-label Pilot Study of Oxatomide in Steroid-Naive Duchenne Muscular Dystrophy
Condition: Muscular Dystrophy, Duchenne
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will help to determine the safety and efficacy of the mast cell stabilizer
      Oxatomide as a treatment for Duchenne muscular dystrophy (DMD). Boys with DMD who are
      enrolled in this study will should not have taken steroids to treat DMD for at least twelve
      months, and should not have taken any nutritional supplements for at least three months.
      Subjects will complete a two screening visits within a one-week period, and if enrolled will
      then have their strength tested monthly for three months before beginning therapy with
      Oxatomide. Once Oxatomide therapy is started, participants will have their strength tested
      monthly for six months. Following the six month treatment period, participants will be given
      the option to remain on Oxatomide until the study is completed.
    


Intervention name(s): Oxatomide (tinset)
Intervention type(s): Drug
Intervention MeSH terms: Oxatomide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Duchenne; muscular; dystrophy; controlled clinical trial; CINRG
Efficacy and Safety of FTY720 in Patients Who Receive a Kidney Transplant
Condition: Kidney Transplantation
Study type: Interventional
Phase: Phase 3

Summary: 
      The efficacy and safety of FTY720 is being evaluated in patients who receive a kidney
      transplant.
    


Intervention name(s): FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids; FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids; MMF 2 g + full-dose Neoral (FDN) + corticosteroids
Intervention type(s): Drug; Drug; Drug
Intervention description(s): FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids; FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids; mycophenolate mofetil (MMF) + full-dose Neoral (FDN) + corticosteroids
Intervention MeSH terms: Cyclosporine; Cyclosporins; Fingolimod Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Kidney, transplantation, rejection, immunosuppression
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of ADC3680B in Subjects With Partly Controlled Atopic Asthma
Condition: Atopic Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is to examine the safety, tolerability, pharmacokinetics and functional activity
      of ADC3680B administered once daily for 28 days in subjects with partly controlled atopic
      asthma.
    


Intervention name(s): ADC3680B oral; Placebo oral
Intervention type(s): Drug; Drug
Intervention description(s): Once daily for 28 days; Once daily for 28 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study Comparing Amounts of Tafamidis In The Blood With Or Without Food
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 2 part study. In part 1 of the study, 3 different formulations of the same dose of
      tafamidis will be compared. Subjects will be fasted for each test and every subject will test
      all 3 different formulations. After swallowing tafamidis, tafamidis blood concentrations will
      be measured periodically for 6 days. After 14 days, subjects will take a different
      formulation of tafamidis and tafamidis blood concentrations will be measured periodically for
      6 days. After another 14 days, the last formulation will be tested in the same way. In part 2
      of the study, depending on the results of part 1, either none, one or 2 of the formulations
      tested in part 1 will be tested comparing the same formulation when given either with or
      without food. Additionally, depending on the results of part 1 of the study, different doses
      of the formulations may be compared.
    


Intervention name(s): tafamidis; tafamidis; tafamidis
Intervention type(s): Drug; Drug; Drug
Intervention description(s): relative bioavailability; fasted; fed
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effect of High-fat/High-sugar Diet on Food Reward Signaling
Condition: Behavior, Eating
Study type: Interventional

Summary: 
      In this randomized, single-blinded basic research study, healthy normal-weight human
      participants are exposed to a high-fat/high-sugar (HF/HS) snack or a low-fat/low-sugar
      (LF/LS) snack twice a day for eight weeks in addition to their regular diet. All participants
      are tested at baseline, after 4 weeks and after 8 weeks of dietary intervention.

      At all time points the investigators acquire the following parameters:

        -  Body weight and composition,

        -  Blood parameters to control for metabolic changes,

        -  Visual analog scales (hunger, satiety, tiredness, etc.),

        -  Fat and sugar concentration preference,

        -  Functional Magnetic Resonance Imaging (fMRI) during a learning and a gustatory
           perception task.

      The investigators hypothesize that the habitual consumption of a small HF/HS snack will
      reduce the preference for low-fat concentrations and will have an impact on brain response to
      the anticipation and consumption of palatable food. Moreover, the investigators hypothesize,
      that HF/HS diet will have an impact neuronal encoding of learning independent of food cues.
      The investigators expect these alterations independent of body weight gain suggesting a
      direct effect of HF/HS diet on neuronal circuits.
    

Detailed description: 
      In this randomized, single-blinded basic research study, healthy normal-weight human
      participants are exposed to a high-fat/high-sugar (HF/HS) snack or a low-fat/low-sugar
      (LF/LS) snack twice a day for eight weeks in addition to their regular diet. The
      investigators test the effect of this dietary intervention on body weight, metabolic
      parameters such as insulin sensitivity, blood cholesterol and triglycerides, the preference
      of fat and sugar taste, the brain response to milkshake anticipation and consumption, and as
      the neuronal coding of prediction error learning. Here, all participants are tested at
      baseline, after 4 weeks and after 8 weeks of dietary intervention using behavioral tasks,
      fMRI and blood sampling. The investigators hypothesize that the habitual consumption of a
      small HF/HS snack will reduce the preference for low-fat concentrations and impact brain
      response to the anticipation and consumption of palatable food. Moreover, the investigators
      hypothesize, that HF/HS diet will have an impact neuronal encoding of learning independent of
      food cues. The investigators expect these alterations independent of body weight gain
      suggesting a direct effect of HF/HS diet on neuronal circuits.
    

Intervention name(s): High-Fat/High-Sugar (HF/HS) Diet; Low-Fat/Low-Sugar (LF/LS) Diet
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Diastolic Dysfunction in Aortic Regurgitation
Condition: Aortic Regurgitation
MeSH terms: Aortic Valve Insufficiency
Study type: Interventional

Summary: 
      Follow-up study in patients with severe aortic regurgitation after successful valve
      replacement. Systolic and diastolic function were assessed and persistent diastolic
      dysfunction was observed late (7-10 years) after operation.
    

Detailed description: 
      Background

      Patients with severe aortic regurgitation show eccentric LV hypertrophy and structural
      changes of the myocardium. Reversibility of functional and structural changes after
      successful valve replacement may be limited. Persistent diastolic dysfunction has been
      observed in the present study late after aortic valve replacement. This finding has been
      explained by incomplete regression of the extra-cellular matrix 7 years after valve
      replacement. Interstitial fibrosis remains unchanged compared to the preoperative situation
      but was increased early after operation due to the reduction in LV muscle mass. Regression of
      LV hypertrophy was 40% after 2 and 55% after 7 years of valve replacement. Myocardial muscle
      fibers decreased slightly but remained hypertrophied even late after operation. Interstitital
      fibrosis was found to be positively correlated to myocardial stiffness and inversely to LV
      ejection fraction.

      Thus, persistent diastolic dysfunction with maintained systolic ejection performance can be
      observed late after successful valve replacement in patients with severe aortic
      regurgitation. Altered diastolic function has been associated with increased filling
      pressures during strenuous exercise with signs of dyspnea.

      Objective

      Evaluation of myocardial structure and function in patients with chronic volume overload
      before and after valve replacement(LV-remodeling).

      Methods

      Pressure-volume measurements and myocardial biopsy samples for assessing myocardial function
      and structure.
    

Intervention name(s): Aortic Valve Replacement
Intervention type(s): Procedure
Intervention description(s): Surgical valve replacement of the aorta
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diastolic function; aortic regurgitation; aortic valve replacement; left ventricular hypertrophy; myocardial structure; LV remodeling; Muscular regression; LV fibrous tissue