bioihbjkbjnl/mcl2 huggingface dataset:
Study in Parkinson's Disease of Exercise
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The purpose of this study is to learn more about the effects of exercise on patients who have
      been recently diagnosed with Parkinson's disease (PD). The investigators are going to test
      two levels of exercise (moderate to vigorous) against no exercise. The investigators think
      that exercise may reduce the symptoms the of PD, and the investigators hope to learn what
      level of exercise will offer the most benefit.
    

Detailed description: 
      The overall objective of this study is to determine the futility or non-futility of
      conducting a randomized controlled trial to determine the effects of exercise on the
      progression of PD symptoms. The primary aim is to determine whether individuals with de novo
      Parkinson's disease (naïve to drug treatment) can achieve the randomly assigned levels of
      mean exercise intensity (60-65% HRmax or 80-85% HRmax) and adhere to the exercise protocol.
    

Intervention name(s): Moderate Exercise; Vigorous Exercise; No Intervention
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months.; Endurance exercise at 80-85% HR max, 4x/wk for 6 months.; No-exercise control (i.e., usual care);
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson Disease; Basal Ganglia Disease; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Neurodegenerative Diseases; Brain Diseases
Preventive Application of Letrozole Decrease Incidence of Early Onset of OHSS
Condition: Ovarian Hyperstimulation Syndrome
MeSH terms: Ovarian Hyperstimulation Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Letrozole is one kind of aromatase inhibitors which may have effect on decrease estrogen in
      luteal phase and inhibit the luteal function of ovary. In 2009, Letrozole was reported as one
      candidate for the treatment or prevention of ovarian hyperstimulation syndrome.
    

Detailed description: 
      Letrozole was proved to be effective in decreasing the estradiol level of luteal phase after
      ovum picked up. In this randomized controlled study, investigators try to observe the
      effectiveness of letrozole on decreasing the incidence of early ovarian hyperstimulation
      syndrome and vascular epithelium growth factor level of women with high ovarian
      hyperstimulation syndrome risks.
    

Intervention name(s): letrozole; Aspirin
Intervention type(s): Drug; Drug
Intervention description(s): letrozole from the day of oocyte retrieval for 5 days; aspirin from the day of oocyte retrieval for 5 days
Other intervention name(s): Femara
Intervention MeSH terms: Aspirin; Letrozole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: letrozole; ovarian hyperstimulating syndrome
Efficacy of Endovascular Catheter Cooling Combined With Cold Saline for the Treatment of Acute Myocardial Infarction
Condition: Myocardial Infarction; Myocardial Reperfusion Injury; Anterior Wall Myocardial Infarction; Inferior Wall Myocardial Infarction
MeSH terms: Myocardial Infarction; Reperfusion Injury; Myocardial Reperfusion Injury; Anterior Wall Myocardial Infarction; Inferior Wall Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine whether treatment of patients suffering from
      ST-elevation myocardial infarction (STEMI) with 1-2 liters of cold saline and central venous
      catheter cooling with Philips InnerCool RTx Endovascular System prior to percutaneous
      coronary intervention (PCI) result in a reduction in infarct size.
    

Detailed description: 
      Acute myocardial infarction (AMI) is the leading cause of mortality in the western world
      today. Although reperfusion of the ischemic myocardium is a prerequisite for myocardial
      salvage, it has been described that the reperfusion in itself may cause additional damage to
      the myocardium (reperfusion injury). In the safety & feasibility trial RAPID MI-ICE we
      demonstrated that treatment of patients suffering from STEMI with 1-2 liters of cold saline
      and central venous catheter cooling with Philips InnerCool RTx Endovascular System prior to
      PCI was feasible, safe and resulted in a 38% reduction in infarct size/myocardium at risk.
      The aim of the present study is to confirm this finding in a larger multicenter trial.

      The study is a randomized, controlled, evaluator blinded, multicenter trial enrolling 120
      patients at ten sites.
    

Intervention name(s): Cooling
Intervention type(s): Procedure
Intervention description(s): 1-2 liters of cold saline and central venous catheter cooling with Philips InnerCool RTx Endovascular System prior to PCI
Other intervention name(s): Hypothermia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: STEMI; primary PCI; Hypothermia; Endovascular cooling; Cardiac MRI
Correlation of Soluble Suppression of Tumorigenicity 2 (ST2) With Golimumab (MK-8259) Response in Participants With Ulcerative Colitis (UC) (MK-8529-022).
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate serum soluble human ST2 protein, the receptor for
      Interleukin-33 (IL-33) and a member of the proinflammatory Interleukin-1 (IL-1) receptor
      superfamily, as a surrogate biological marker predictive of disease outcome and therapeutic
      response to golimumab treatment in participants with moderate to severe UC who have failed on
      prior conventional therapies. The primary endpoints of this study are to correlate serum
      soluble ST2 levels with endoscopic activity (endoscopic subscore of the Mayo score) and
      histological activity (Geboes index) of disease.
    


Intervention name(s): Golimumab
Intervention type(s): Biological
Intervention description(s): Golimumab 50mg/0.5 mL in a single-use, ready-to-use autoinjector. Golimumab is a fully human anti-TNF (tumor necrosis factor) alpha monoclonal antibody that will be administered SC.
Other intervention name(s): SIMPONI
Intervention MeSH terms: Golimumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Treadmill Training With Additional Body Load: Effects on Gait of Subjects With Parkinson´s Disease
Condition: Parkinson´s Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Background: Studies about the effects of walking training with additional body load in
      Parkinson's disease (PD) are lacking. There is evidence that the increase of body load during
      treadmill walking improves reflex activity and leg extensor muscle activity, which are
      impaired in subjects with PD.

      Purpose: The purpose of this study was to assess the effects of treadmill walking training
      with additional body load on the ground reaction forces, spatiotemporal, and kinematic
      variables of the gait of subjects with moderate PD.

      Design: This study was an A1-B-A2 single-case. Setting: The evaluation and the training were
      conducted in a movement analysis laboratory, and at the rehabilitation unit of the
      University, respectively.

      Participants: Nine patients with PD (Hoehn and Yahr 2 through 3) and gait disturbances.

      Interventions: Phases A1 and A2 included 6 weeks of gait training on a treadmill with 10%
      increase of normal body mass. Phase B included 6 weeks of conventional physical therapy.

      Measurements: Measures included the ground reaction forces, spatiotemporal, and kinematic
      variables during overground walking, at baseline and after each phase.
    


Intervention name(s): Treadmill walking training with additional body load
Intervention type(s): Other
Intervention description(s): The training program was divided into three phases (A1-B-A2):
treadmill training with additional body load (A1), control condition (conventional physical therapy) (B). and treadmill training with additional body load again (A2). Each phase lasted six weeks, totaling 18 weeks. Both evaluations and training were performed during on-phase of the medication cycle.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: treadmill; body load; Parkinson's disease; gait
Non-Treatment Study of Factors Affecting Cocaine Drug Choice
Condition: Cocaine Abuse or Dependence; Cocaine Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Observational

Summary: 
      This research deals with behaviors that are part of drug dependence. The purpose is to study
      how certain factors, including money, the amount of drug available, and the amount of work
      effort, affect cocaine drug choice. Specifically, we will examine the effects of two
      issues/factors. The first is how hard individuals are willing to work to obtain a drug; the
      second is how much drug would individuals choose instead of money, when the amount of
      probability of money is predictable or unpredictable.
    

Detailed description: 
      Outpatient Phase: Participants will be outpatients and must come to the Jefferson Avenue
      Research Program three times a week (Mon-Wed-Fri). This phase will last two weeks. At each
      visit participants will be asked to provide a urine sample and to complete questionnaires
      that ask about substance use.

      Inpatient Phase: Participants will live on an inpatient research unit at least 2 consecutive
      nights and possibly up to 20 consecutive nights. Participants cannot have visitors and will
      not be allowed to leave the inpatient unit (except with a staff escort) unless they drop out
      of the study. We will collect daily urine samples to make sure participants are not using any
      drugs except those in the study.

      Participants will take part in multiple trials (up to 11 experimental sessions) where they
      will be given a standard amount of powder (identified as Drug A or Drug B) to inhale through
      a straw into their nose. The powder will contain placebo (a powder containing no drug) or
      different doses of cocaine. We will measure how participants are feeling using questionnaires
      and we will record vital signs-including breathing rate, blood oxygen level, heart rate, and
      blood pressure.

      Participants will also be asked to perform a 3-hour computer task that allows them to work
      for Drug A, Drug B, or money. At the end of the computer task participants will receive the
      amount of drug they earned and a receipt for the amount of money they earned.

      To complete the study, a minimum stay of 16 inpatient nights is required. The maximum stay is
      20 inpatient nights.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Cocaine abusing or dependent research volunteers
      
Biospecimen description: 
      Whole Blood
    
Keywords: Contingency Management; Drug Self-Administration
A Study to Asses Efficacy, Safety and Tolerability of Monthly Long-acting IM Injection of GA Depot in Subjects With RMS
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      A multinational, multicenter, randomized, Phase III, double blind, parallel group, placebo
      controlled study in subjects with Relapsing Forms of Multiple Sclerosis (RMS) to assess the
      efficacy, safety and tolerability of GA Depot, a long acting IM injection of glatiramer
      acetate, administered once every four weeks
    

Detailed description: 
      A total of 1000 subjects are planned to be randomized into this study to receive treatment
      with GA Depot or with matching placebo.

      During the placebo controlled period (PC period, the first 52 weeks of the study immediately
      after randomization) subjects will receive either 40mg of GA Depot or matching placebo, IM,
      once every 4 weeks, for a total of 13 times.

      Subjects who complete the PC period of the study will be offered to continue into the open
      label period (OL period) for an additional 52 weeks, in which all subjects will receive 40mg
      of GA Depot IM once every 4 weeks.
    

Intervention name(s): GA Depot; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Long acting intramuscular injection of glatiramer acetate, once every 4 weeks; IM injection once every 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: During the placebo controlled period subjects will receive either 40mg of GA Depot or matching placebo, IM, once every 4 weeks, for a total of 13 times.
Subjects who complete the PC period of the study will be offered to continue into the open label period for an additional 52 weeks, in which all subjects will receive 40mg of GA Depot IM once every 4 weeks.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; RMS; GA Depot; Multiple Sclerosis, Relapsing-Remitting
Study of ARO-HSD in Healthy Volunteers and Patients With Non-Alcoholic Steatohepatitis (NASH) or Suspected NASH
Condition: Non-alcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and
      pharmacodynamics of single and multiple doses of ARO-HSD in healthy adult volunteers and in
      patients with NASH or suspected NASH.
    


Intervention name(s): ARO-HSD Injection; sterile normal saline (0.9% NaCl)
Intervention type(s): Drug; Drug
Intervention description(s): single or multiple doses of ARO-HSD by subcutaneous (sc) injections; calculated volume to match active treatment, by sc injection
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study Comparing Picoprep With Mannitol and Bisacodyl for Colon Cleansing in Preparation for Colonoscopy
Condition: Bowel Preparation
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a randomized, controlled, parallel group, assessor-blinded study to compare two colon
      cleansing preparations for colonoscopy. Subjects meeting all inclusion and exclusion criteria
      will be randomized and assigned to one of two study groups: Group I (PicoPrep) or Group II
      (Mannitol). In Group I, subjects will take one sachet of PicoPrep on the day before
      colonoscopy, and another sachet on the day of colonoscopy. In Group II, subjects will take
      Bisacodyl on the day before colonoscopy, and Mannitol on the day of colonoscopy.
    


Intervention name(s): sodium picosulfate, magnesium oxide and citric acid (Picoprep®); mannitol; Bisacodyl
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Mannitol; Bisacodyl; Picosulfate sodium; Magnesium Oxide; Citric Acid; Sodium Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Study Evaluating a Combined Administration of Lecozotan SR and Citalopram in Young Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the safety and tolerability of lecozotan SR and citalopram when coadministred to
      healthy subjects.
    


Intervention name(s): Lecozotan SR; Citalopram
Intervention type(s): Drug; Drug
Intervention MeSH terms: Citalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Adult
Schistosoma Mansoni Morbidity in Children Aged 1-5 Years
Condition: Intestinal Schistosomiasis
MeSH terms: Schistosomiasis; Schistosomiasis mansoni
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is about intestinal schistosomiasis, commonly known as bilharzia, in children aged
      1-5 years along Lake Victoria shoreline.The children will be screened for S. mansoni and the
      effects of the disease will be assessed.Children found positive with S. mansoni will be
      treated with praziquantel and followed up for a year.
    

Detailed description: 
      The study has three phases: in the first phase (Phase I) a baseline pretreatment
      schistosomiasis morbidity assessment of children aged 1-5 years will take place. The
      Kato-Katz technique will be used to detect and enumerate S. mansoni eggs in faecal samples
      from each participating child. Communities with the highest S. mansoni prevalence and
      intensity will be chosen and included in the study. In the second phase (Phase II) the S.
      mansoni positive children will be divided randomly into two intervention groups, single and
      double dose praziquantel treatment arms. Abdominal ultrasound will be combined with clinical
      examination to accurately identify hepatosplenomegaly. The sizes of both the liver and spleen
      will be examined. Anthropometric measurements and Hb for each child will also be recorded. In
      the last phase (Phase III), the effect of praziquantel on S. mansoni morbidity will be
      evaluated in all the treated children aged 1-5 years.
    

Intervention name(s): Praziquantel
Intervention type(s): Drug
Intervention description(s): All the registered S. mansoni infected children aged 1-5 years will be randomly divided into two treatment arms: single and double dose. A second those will be administered after two weeks following the last treatment.
Intervention MeSH terms: Praziquantel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schistosoma mansoni; morbidity; chemotherapy
Congenital Syphilis Prospective Cohort With Retrospective Evaluation
Condition: Syphilis, Congenital
MeSH terms: Syphilis; Syphilis, Congenital
Study type: Observational

Summary: 
      Syphilis is an infectious disease caused by Treponema pallidum. In children, there are two
      different forms of this disease; acquired syphilis and congenital syphilis, which results
      from transplacental transmission of spirochetes.

      The worldwide incidence of congenital syphilis has increased in past years, probably due to
      inadequate control of pregnant women and lack of early diagnose and treatment in acute
      infected adults.

      This infection can have numerous and non-specific manifestations at all stages, and may
      simulate other diseases, which can delay diagnose if not suspected.

      A high number of newborns can be asymptomatic, so diagnose is confirmed or discharged by
      serologic testing after 6 to 10 months of age.

      This study will observe the clinical presentation and the laboratory of patients with CS
      treated.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        In older children, the sexual route for abuse will be ruled out as a means of interrogation
        infection and analysis of family dynamics by a multidisciplinary team.
      
Keywords: Congenital syphilis; VDRL; CSF; Clinical manifestations
Geodon for the Treatment of Refractory Social Anxiety Disorder
Condition: Social Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to examine the effectiveness and tolerability of augmentation
      treatment of ziprasidone to achieve remission among patients with social anxiety disorder
      (SAD) who did not remit on sertraline treatment alone
    

Detailed description: 
      This is a two-phase study consisting of 8 weeks of open label treatment with sertraline
      (50-200 mg/day) in patients with SAD and in those who fail to demonstrate symptom remission
      on sertraline alone, 8 weeks of randomized, double-blind, placebo-controlled augmentation
      with ziprasidone.
    

Intervention name(s): Ziprasidone; Sertraline
Intervention type(s): Drug; Drug
Intervention description(s): Sertraline augmentation with ziprasidone; Treatment by sertraline in open label phase, followed by ziprasidone/placebo randomized augmentation in the randomized phase
Other intervention name(s): Geodon; Zoloft
Intervention MeSH terms: Ziprasidone; Sertraline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: anxiety disorder; SAD; ziprasidone; sertraline; antidepressant; antipsychotic
Corneal WFG Versus AF Trans PRK in Myopic Patients With High Corneal HOA
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      compare the efficacy, safety and predictability of corneal wavefront guided (WFG) and
      aberration free ablation in single-step transepithelial photorefractive keratectomy
      (TransPRK) in myopic patients with high pre-existing corneal higher order aberrations (HOAs).
    

Detailed description: 
      Objectives:to compare the efficacy, safety and predictability of corneal wavefront guided
      (WFG) and aberration free ablation in single-step transepithelial photorefractive keratectomy
      (TransPRK) in myopic patients with high pre-existing corneal higher order aberrations (HOAs).

      Background: Corneal WFG and aberration free treatments have been proposed as methods to
      achieve better visual, refractive, and optical outcomes.

      Methods: prospective case series was conducted in El-Hekma Eye-LASIK center, Menoufia
      governorate, Egypt during the period from January 2017 to December 2017. TransPRK was
      performed to eligible myopic patients with or without astigmatism with corneal HOAs ≥ 0.35 µ
      utilizing either aberration free or corneal WFG patterns provided by ORKCAM software (SCHWIND
      eye-tech-solutions, Kleinostheim, Germany). Uncorrected distance visual acuity (UDVA),
      manifest and cycloplegic refractions, best spectacle corrected distance visual acuity (CDVA),
      thorough slit lamp examination and corneal topography were assessed and repeated six months
      postoperatively.
    

Intervention name(s): corneal WFG group; aberration free group
Intervention type(s): Procedure; Procedure
Intervention description(s): TransPRK using ESIRIS flying spot excimer laser system (SCHWIND AMARIS®500E, SCHWIND eye-tech-solutions, Kleinhostheim, Germany), with 500 Hz repetition rate for faster treatments and scanning spots and with smart pulse technology. Eye-tracking during laser ablation was achieved using a 1050 Hz infrared eye tracker centered on the pupil. Static cyclotorsion control (SCC) compensation was obtained for all patients in corneal WFG group.; TransPRK was performed to eligible myopic patients with or without astigmatism with corneal HOAs ≥ 0.35 µ utilizing aberration free patterns provided by ORKCAM software (SCHWIND eye-tech-solutions, Kleinostheim, Germany)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: aberration free; corneal wavefront guided; higher order aberrations; photorefractive keratectomy.