bioihbjkbjnl/mcl2 huggingface dataset:
A Feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR Guided Focused Ultrasound for Unilateral Pallidotomy in the Treatment of Dyskinesia of Parkinson's Disease
Condition: Levodopa Induced Dyskinesia in Patients With Parkinson's Disease
MeSH terms: Parkinson Disease; Dyskinesias
Study type: Interventional
Phase: Phase 1

Summary: 
      The proposed study is to evaluate the safety and initial effectiveness of the ExAblate
      Transcranial MRI-guided focused ultrasound (MRgFUS) treatment of patients with dyskinesia of
      Parkinson's Disease (PD)

        -  Safety: To evaluate the incidence and severity of adverse events (AE/AEs) associated
           with ExAblate Transcranial MRgFUS treatment of dyskinesia of PD

        -  Effectiveness: To determine the level of effectiveness of the ExAblate Transcranial
           MRgFUS treatment of dyskinesia of PD.Efficacy will be determined utilizing the UPDRS-IV
           for dyskinesia in PD from examinations at baseline and every 3-Months post-ExAblate
           treatment.

      This study is designed as a prospective, single-site, single arm, nonrandomized study.
      Assessments will be made before and three months after MRgFUS for clinical symptom relief,
      quality of life (QoL) improvements, and safety of MRgFUS in the treatment of LID. Relative
      Safety will be evaluated using a common description of Significant Clinical Complications for
      patients treated in this study. This study will be performed on the 3T MR scanners.
    


Intervention name(s): transcranial magnetic resonance guided focused ultrasound pallidotomy
Intervention type(s): Device
Intervention description(s): Focused ultrasound is an attractive method for non-invasive thermal ablation of soft tissue, including functional brain targets. Treatment begins by acquiring a series of MR images of the target organ. The physician then identifies a target volume in the MR images, and delineates the treatment contours on the images. Therapy planning software calculates the parameters required to effectively treat the defined target volume. During the treatment, an ultrasound transducer generates a point of focused ultrasound energy, called a sonication. The sonication raises the tissue temperature within a well-defined region, enabling neurophysiological assessment in the low range, and thermal coagulation at higher ranges. MR images acquired during sonication provide a quantitative, real-time temperature map of the target area to confirm the location of the sonication and the size of the affected region.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parkinson's disease; ultrasound; dyskinesia; magnetic resonance
Computer Screen Properties Study
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Study type: Interventional

Summary: 
      The purpose of this study is to identify how various popular methods of changing computer
      screen settings affect dry eye symptoms (eye pain, grittiness, tearing, burning, etc.).
      Specifically, this study will examine if there are differences in effects of blue light
      blocking (F.lux app or night shift) versus reducing screen brightness on the symptoms of dry
      eye.
    

Detailed description: 
      After the initial survey, participants will be randomized by a randomization tool internal to
      Redcap to be in one of three arms of intervention: no intervention, screen brightness
      reduction to 50%, and tone modulator application. Instructions will be e-mailed to
      participants to explain the steps they must take depending on which treatment arm they are
      randomized to. Adherence will be monitored and assessed at the time of post-intervention
      survey. If participants have issues with the software of complying, they will be able to
      contact the research team at any point.
    

Intervention name(s): Brightness
Intervention type(s): Other
Intervention description(s): Changing the colors or brightness on the device (computer screen) for one month
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Efficacy of Intraperitoneal Versus Intravenous Lidocaine for Postcesarean Pain Relief
Condition: Postcesarean Pain Relief
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Objective: To evaluate intraperitoneal (IP) lidocaine administration and intravenous (IV)
      lidocaine infusion for postoperative pain control after cesarean section.

      Study design: prospective randomized, double-blind, placebo-controlled study. Patients and
      methods: Initially, 165 pregnant full-term females, indicated to be underwent elective
      cesarean delivery for various indications were randomized equally to either group C (control,
      IP and IV saline), group IP (intraperitoneal lidocaine administration), or group IV
      (intravenous lidocaine infusion).Five patients were excluded from each group for various
      reasons. The outcome measures were postoperative pain scoring, total pethidine consumption
      and the need for postoperative analgesia.
    


Intervention name(s): Intravenous normal saline; Intraperitoneal normal saline; Intraperitoneal Lidocaine; Intravenous Lidocaine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Normal saline in a volume equivalent to that used in intravenous lidocaine group; Patients received 00 ml of saline intraperitoneally; Patients received 1.75 ml/kg of 0.2% lidocaine (3.5mg/kg) with parietal peritoneal closure.; Patients received 1.5mg/kg of intravenous 1% lidocaine as bolus dose at induction and 2mg/kg/hour as continuous infusion of intravenous lidocaine until one hour after surgery.
Other intervention name(s): IV Saline; IP Saline; IP Lidocaine; IV Lidocaine
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Open, Pharmacokinetic Study of Caspofungin Acetate in Immunocompromised Young Children With Febrile Neutropenia (0991-042)
Condition: Fungal Infection
MeSH terms: Mycoses; Neutropenia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open-label study of MK0991 in children between 3 to 24 months of age with new
      onset fever and neutropenia. The purpose of the study is to investigate plasma drug levels of
      caspofungin.
    


Intervention name(s): caspofungin acetate
Intervention type(s): Drug
Intervention description(s): (50 mg/m²/day and 70 mg/m²/day) Caspofungin will be given for a minimum of 4 days (or at least 2 separate days of 7-point plasma sampling). Patients will be administered caspofungin for a maximum of 28 days.
Other intervention name(s): MK0991; CANCIDAS®
Intervention MeSH terms: Caspofungin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Outcome After Laparoscopic Versus Open Pancreaticoduodenectomy
Condition: Pancreatoduodenectomy
Study type: Observational

Summary: 
      Aim of the study :

      To determine the morbimortality of Laparoscopic pancreaticoduodenectomy (LPD) compared to the
      gold standard Open pancreaticoduodenectomy approach (OPD).

      Methods :

      This is a monocentric retrospective study based on a prospectively maintained clinical
      database. The study included 28 consecutive patients operated, between January 2016 and March
      2019, of Laparoscopic pancreaticoduodenectomy (LPD) that we compared to 62 patients operated
      with the classical open approach by the same surgeon before the first laparoscopic resection
      at our institution.
    

Detailed description: 
      The progress achieved over the last 20 years and the growing experience of visceral surgeons
      in minimally invasive surgery allow us today to embark on increasingly complex surgeries.

      Laparoscopic surgery has even become the gold standard approach for many interventions,
      whether for bariatric functional surgery, reflux surgery, pelvic static disorder surgery, but
      also for tumor surgery such as colorectal cancer, esophageal or tail of the pancreas.

      However, there are still interventions which, due to their technical difficulty, do not find
      unanimous consensus among the international scientific community for a possible minimally
      invasive approach.

      The close contact of the pancreatic gland with the splenomesaraic trunk making laparoscopic
      dissection difficult with risk of uncontrollable bleeding.

      It seems, however, that the finesse of the dissection and coagulation instruments and the
      precision of today's optics make it possible to approach the head of the pancreas in
      completely satisfactory conditions.

      Several centers around the world have developed the LPD technique with encouraging results in
      terms of perioperative mortality without showing any advantage over laparotomy.

      At the Montpellier University Hospital we started performing Laparoscopic
      pancreaticoduodenectomy (LPD) at the beginning of 2016.

      The aim of this study is to assess, on the one hand, the morbimortality and the quality of
      surgery linked to the development of this relatively new technique in a reference center for
      pancreatic surgery and on the other hand to assess a possible learning curve effect within
      our experience.
    

Intervention name(s): Pancreatoduodenectomy
Intervention type(s): Procedure
Intervention description(s): Open or laparoscopic pancreato-duodenectomy with pancreatojejunal anastomosis
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who had Pancreatoduodenectomy with pancreatojejunal anastomosis whatever the
        indication
      
Keywords: Pancreatoduodenectomy; Benign or malign pathology; Mini-invasive approach; Morbimortality; Laparoscopic approach
Risk Factors for Early POCD in the Patients With PSM Undergoing CRS-HIPEC
Condition: Postoperative Cognitive Dysfunction
MeSH terms: Peritoneal Neoplasms; Postoperative Cognitive Complications; Cognitive Dysfunction
Study type: Observational

Summary: 
      Objectives to investigate the incidence and associated factors for early postoperative
      cognitive dysfunction in the patients with peritoneal surface malignancies undergoing
      cytoreductive surgery and hyperthermic intraperitoneal chemo-therapy(CRS-HIPEC).Methods fifty
      patients aged 18-65 yr were included in the research and were grouped base on the score of
      neuropsychological assessments which had done in the ward at 7 day before and after the
      surgery. The investigators monitored various indicators in the perioperative period, such as
      age, body weight, sex, education, duration of operation, intraoperative blood loss,
      cardiovascular events, amount of fluid infused per hour. Meanwhile, the concentration of
      serum amploid A (SAA),IL-1beta,TNF-alpha,HMGB1,S100b,cortisol and Abeta40 were measured at
      the various stage of the operation and 24 hours after the operation, and the differences of
      data between postoperative cognitive dysfunction(POCD) and Non-POCD groups were analyzed.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients with peritoneal surface malignancies undergoing cytoreductive surgery and
        hyperthermic intraperitoneal chemo-therapy
      
Biospecimen description: 
      venous blood sample
    
Keywords: peritoneal surface malignancies; Post operative cognitive dysfunction
A Study to Evaluate Molnupiravir (MK-4482; MOV) in Participants With Severe Renal Impairment (MK-4482-003)
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This purpose of this study is to evaluate the plasma pharmacokinetics (PK) of
      N-hydroxycytidine (NHC), the nucleoside metabolite of molnupiravir, after a single oral dose
      of 800 mg molnupiravir in participants with severe renal impairment compared to healthy mean
      matched control participants. This study will also assess the safety and tolerability of
      molnupiravir in participants with severe renal impairment and the urinary excretion of NHC
      after a single oral dose of 800 mg molnupiravir in participants with severe renal impairment
      compared to healthy mean matched control participants. The primary hypothesis is that the
      plasma PK participants with severe renal impairment will be similar to that observed in the
      healthy mean matched control participants.
    


Intervention name(s): Molnupiravir
Intervention type(s): Drug
Intervention description(s): Four 200 mg capsules administered orally as a single dose
Other intervention name(s): MK-4482; MOV; EIDD-2801
Intervention MeSH terms: Molnupiravir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Apathy Cure Through Bupropion in Huntington's Disease
Condition: Apathy; Huntington's Disease
MeSH terms: Huntington Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The influence of bupropion compared to placebo on the change of apathy as quantified by the
      apathy evaluation scale (AES-I, where I [informant] is a friend or family member familiar
      with the daily activities of the subject) in patients with HD after ten (10) weeks of
      treatment.
    

Detailed description: 
      The safety and tolerability of Bupropion in HD.

      The influence of Bupropion compared to placebo on the:

        -  change of apathy as quantified by the AES-C (clinician) or the AES-S (self),

        -  change of motor symptoms (UHDRS) and quantitative grip force motor assessment,

        -  change of cognitive symptoms (UHDRS and MMSE),

        -  change of psychiatric symptoms (UHDRS, HADS),

        -  change of activities of daily living (UHDRS),

        -  change of the NPI caregivers' distress score (NPI-D),

        -  change of ventral striatal and ventromedial prefrontal activation in response to a
           reward paradigm as quantified by fMRI.
    

Intervention name(s): Bupropion; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Crossover design: Oral administration of 150 mg bupropion once daily for 2 weeks, followed by 300 mg bupropion once daily for subsequent 8 weeks, tapering: 150 mg bupropion once daily for 7 days; Crossover design: Oral administration of placebo once daily for 2 weeks, followed by placebo once daily for subsequent 8 weeks, tapering: placebo once daily for 7 days
Other intervention name(s): Wellbutrin, Budeprion, Prexaton, Elontril, Aplenzin; control
Intervention MeSH terms: Bupropion
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Huntington's disease; Apathy; Bupropion
Orchestra Pregnancy Observational Study in Poland
Condition: Type 1 Diabetes Mellitus; Pregnancy
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational [Patient Registry]

Summary: 
      The aim of this project is to document the use of insulin pump therapy (CSII), including
      sensor augmented pump therapy (SAP), before, during and after pregnancy in women with type 1
      Diabetes Mellitus benefiting from the Orchestra donation of Paradigm REAL-Time and Paradigm
      Veo pumps in Poland.
    

Detailed description: 
      The project is designed as a multi-center prospective observational Post-Market-Release study
      to be conducted in up to 30 centers in Poland.

      Total duration of the study per patient will be up to 22 months (up to 12 months
      pre-conception phase, pregnancy, and 6 weeks after delivery). The optimal study start is the
      beginning of pre-conception phase, however, pregnant women up to the 16th week of pregnancy
      can participate in the study too. The study end is 6 weeks after delivery. If conception does
      not occur within 12-months, the patient's study participation is terminated, and the insulin
      pump might be taken away from the patient. The following therapy is decided by the
      investigator. If the pump is not taken away after the 12-month of trial period for
      conception, the patient can continue insulin pump therapy until the pump is needed for
      another patient.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study subject population is women with Type 1 Diabetes Mellitus at the age of 18-45 who

          -  plan pregnancy

          -  are in the early phase of pregnancy, up to the 16th week
      
Biospecimen description: 
      Whole blood, serum, urine samples as required in routine practice before, during and after
      pregnancy in women with Type 1 Diabetes Mellitus
    
Keywords: Type 1 Diabetes Mellitus - T1DM; Pregnancy; Insulin Pump; Glucose Sensor; Continuous Subcutaneous Insulin Infusion - CSII; Sensor Augmented Pump - SAP; Continuous Glucose Monitoring - CGM
Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Influenza Vaccines GSK2654911A and GSK2654909A Administered to Adults 18 to 64 Years of Age
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity of
      different formulations of a two-dose primary series and booster vaccination of monovalent
      Influenza H9N2 vaccine manufactured in Quebec, Canada with and without adjuvant, in adults 18
      to 64 years of age.
    


Intervention name(s): Investigational H9N2 vaccine GSK2654911A; Investigational H9N2 vaccine GSK2654909A; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 2 or 3 doses of GSK2654911A (different formulations) followed by 1 or 0 dose of saline placebo respectively, depending in the treatment group. All doses to be administered intramuscularly (IM) in deltoid region of arm.; 2 or 3 doses of GSK2654909A followed by 1 or 0 dose of saline placebo, respectively (treatment 5). All doses to be administered IM in deltoid region of arm.; 1 dose of saline placebo administered intramuscularly (IM) in deltoid region of arm.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza; Immunogenicity; H9N2; Safety
IT-based Training in Obesity
Condition: Obesity; Inactivity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Though possibly cost-saving, there is little scientific evidence for the effectiveness and
      reasonable modality of internet-delivered physical activity interventions in primary
      prevention. The aim of the study is to compare the influence of different personal and
      IT-based service levels on the activity outcome of obese, sedentary persons to evaluate the
      minimum level of service necessary for a maximum increase in activity and weight reduction.
    


Intervention name(s): Physical activity
Intervention type(s): Behavioral
Intervention description(s): 6-month physical activity intervention (endurance activities) delivered by internet with tailored training schedules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
The Effect of Eprosartan on Hormones and Kidney Function in Patients With Essential Hypertension
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      We, the investigators at Holstebro Hospital, want to test the hypothesis that eprosartan
      reduces the activity of the sympathetic nervous system in patients with essential
      hypertension - during baseline conditions and after activation of the sympathetic nervous
      system.
    


Intervention name(s): Eprosartan
Intervention type(s): Drug
Intervention MeSH terms: Eprosartan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Test Re-Test Reliability of [11C]PF-06809247 as a Novel PET Tacer
Condition: Neuroinflammation
MeSH terms: Neuroinflammatory Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study measuring the binding kinetics and test-retest characteristics of a
      subpharmacological dose of [11C]PF-06809247 Monoacylglycerol lipase (MAGL) Positron Emission
      Tomography (PET) tracer in healthy adult subjects.
    


Intervention name(s): [11C]PF-06809247
Intervention type(s): Drug
Intervention description(s): PET Tracer
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: PET; [11C]PF-06809247; Reliability; Scan, Safety
The Safety & Efficacy of Combination BMS-201038 (AEGR-733) & Ezetimibe vs. Monotherapy in Moderate Hypercholesterolemia
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The main objectives of this study are to evaluate the efficacy and safety of combination
      therapy BMS-201038 (AEGR-733) plus ezetimibe vs. each agent given alone on LDL cholesterol
      and other lipoproteins over 12 weeks of therapy.
    

Detailed description: 
      Subjects will participate in this study for approximately 14-17 weeks. This study has 2
      periods: 1) a 1-2-week screening period with 2 visits where baseline cholesterol and other
      characteristics will be evaluated to determine study eligibility. This period also includes a
      4-week washout for patients on prior lipid-lowering therapies; and 2) a 12-week treatment
      period with interim visits at weeks 4 and 8.

      85 subjects were randomized into one of 3 treatment arms with equal probability. In treatment
      arm 1, subjects will receive BMS-201038 (AEGR-733) 5 mg plus ezetimibe placebo. In treatment
      arm 2, subjects will receive BMS-201038 (AEGR-733) placebo plus 10 mg of ezetimibe. In
      treatment arm 3, subjects will receive BMS-201038 (AEGR-733) 5 mg plus ezetimibe 10 mg. After
      4 weeks of treatment, subjects in arms 1 and 3 will be force-titrated to BMS-201038
      (AEGR-733) 7.5 mg. After another 4 weeks of treatment, subjects in arms 1 and 3 will then be
      force-titrated to BMS-201038 (AEGR-733) 10 mg for 4 more additional weeks of treatment.
      Subjects in arm 2 will continue to receive BMS-201038 (AEGR-733) matching placebo for the
      entire 12 weeks of treatment. Subjects randomized to ezetimibe 10 mg in arms 2 and 3 and
      ezetimibe placebo in arm 1 will remain on these doses for the entire 12-week treatment
      period.
    

Intervention name(s): BMS-201038 (AEGR-733); Ezetimibe
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Cholesterol