bioihbjkbjnl/mcl2 huggingface dataset:
Regional Anesthesia Versus General Anesthesia on Circulating Tumor Cells (CTC)
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Neoplastic Cells, Circulating
Study type: Observational

Summary: 
      The purpose of the study is to determine whether the type of anesthesia during breast cancer
      surgery has any impact on the way a patient's immune system functions for a brief period
      after surgery. If the investigators find that one type of anesthesia versus the other is more
      beneficial to a patient's immune system, then the investigators may use this information to
      design a larger study to exam the effect of anesthesia better.
    

Detailed description: 
      There are two different types of anesthesia that the investigators can use for subjects
      undergoing breast surgery. The first type is called "general anesthesia" (GA) which is when a
      person "goes to sleep" with a breathing tube and then receives intravenous (IV) pain medicine
      during and after surgery to minimize surgical pain. The other type of anesthesia is called
      "regional anesthesia" (RA), or "nerve blocks" which numb up the nerves that supply the breast
      area. By doing this type of anesthesia, subjects often don't go "to sleep" with a breathing
      tube, instead, they get heavy IV sedation and take a "deep nap" during the surgery.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        We will enroll female and male military health care beneficiaries between the ages 18-85
        years old presenting with the diagnosis of primary non-metastatic breast cancer, American
        Joint Committee on Cancer (AJCC) Stages I, II or III, undergoing surgery with curative
        intent
      
Biospecimen description: 
      Samples collected for CTC analysis (2 tubes of 8ml of blood) will be drawn at 4 time points:
      pre-operative (at least 24 hours before surgery), immediate prior to surgery, 12-24 hours
      post-operative, and 5-7 days post-operative.
    
Keywords: Anesthesia, Circulating tumor cells
Comparison of Low-Dose, Standard-Dose Ticagrelor and Clopidogrel for Inhibition of Platelet Reactivity in Patients With Acute Coronary Syndromes
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare Low-Dose, Standard-Dose Ticagrelor and Clopidogrel
      for Inhibition of Platelet Reactivity in Patients with Acute Coronary Syndromes
    


Intervention name(s): ticagrelor; clopidogrel
Intervention type(s): Drug; Drug
Intervention MeSH terms: Clopidogrel; Ticagrelor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Inhibition of Platelet Reactivity; ticagrelor; clopidogrel; Pharmacodynamics; Pharmacokinetics
Implementation of a New Motor Skill Learning Therapeutic Device in Children With Cerebral Palsy Rehabilitation
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      Study of the efficiency of a new interactive interface to apply all the therapeutic
      principles of motor skill learning used in high dosage intensive interventions. Investigation
      of its effects on motor, functional and neuroplastic changes in children after high and low
      dosage intensive interventions using or not the interface.
    


Intervention name(s): Hand Arm Bimanual Intensive Therapy Including Lower Extremities; Conventional physical and occupational therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Intensive intervention focusing on a constant bimanual coordination with a lower extremities and trunk control stimulation during play and functional activities. 50% of therapeutic time will be performed using the new interactive interface; Conventional therapy (physical and occupational therapy) is mainly based on neurodevelopmental therapeutic principles. 50% of therapeutic time will be performed using the new interactive interface
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: motor function; motor skill learning
Testosterone Treatment for Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Since men are less likely to develop multiple sclerosis, the hypothesis was that testosterone
      might be protective in MS. Men with MS for followed untreated for 6 months, followed by a 12
      month treatment period with Androgel.
    

Detailed description: 
      Background: Men are less susceptible to many autoimmune diseases including multiple sclerosis
      (MS). Possible causes for this include sex hormones and/or sex chromosome effects.
      Testosterone treatment ameliorates experimental allergic encephalomyelitis (EAE), an animal
      model of MS, but the effect of testosterone supplementation on men with MS is not known.

      Design, Setting and Participants: Ten men with relapsing remitting MS were studied using a
      crossover design whereby each patient served as his own control. There was a six-month
      pretreatment period followed by a twelve month period of daily treatment with 100mg of
      testosterone gel.

      Main Outcome Measures: Brain atrophy and Cognitive testing
    

Intervention name(s): Androgel 10 grams of gel containing 100 mg of testosterone
Intervention type(s): Drug
Intervention description(s): testosterone gel
Other intervention name(s): testosterone
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: multiple sclerosis; testosterone
Effect Of High-Intensity Focused Ultrasound On Abdominal Skin Laxity Post Sleeve Gastrectomy
Condition: Skin Laxity; Gastrostomy
MeSH terms: Cutis Laxa
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate the therapeutic effect of High intensity focused
      ultrasound in treatment of abdominal skin laxity post sleeve gastrectomy.
    

Detailed description: 
      Lax skin is a common consequence of bariatric weight loss, and it may require one or more
      plastic interventions.

      This study carried out to investigate the effectiveness of High-intensity focused ultrasound
      (HIFU) in treatment of abdominal skin laxity post sleeve gastrectomy.
    

Intervention name(s): High intensity focused ultrasound; topical firming creams
Intervention type(s): Device; Other
Intervention description(s): Parameters:
Transducer frequency 7-2-mhz 1.5-9.0-mm focal depth. The pulse duration for each individual exposure ranged from 25 to 40 milliseconds.
Energy per ultrasound pulse ranged from 1.0 to 1.5 J; medical topical firming creams
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
The Effect of Inhibitory Control Processes Induced by Rectal Distension on Impulse Control Measured by Stroop Task Performance and Intertemporal Discounting.
Condition: Healthy Subjects
Study type: Interventional

Summary: 
      The aim of this study will be to investigate the effect of rectal distension, controlled by
      electronic barostat, on cognitive control ability in healthy subjects. We will use the Stroop
      task and an intertemporal choice task as standard instruments. Like bladder control and
      rectal control, both Stroop task performance and intertemporal choices - though very
      different tasks at the surface - are dependent on the conflict monitoring function of the
      anterior cingulate cortex. The Stroop task requires the naming of the print color of a series
      of visually presented color words, and reaction time and error rates are typically used as
      performance indicators. When word color and word meaning do not match, performance of the
      task (color naming) requires the inhibition of a (near) automatic response (word reading).
      The intertemporal choice task consists of a series of choices between a sooner smaller
      monetary reward and a larger but later reward. The choices are constructed such that they
      allow the estimation of a discount parameter, which is an index for the level of
      impulsiveness manifested by the participant at the time the choices are made.

      The hypothesis is that the inhibition induced by the urge generated during rectal distension
      will improve cognitive inhibitory performance, as has previously been shown for bladder
      filling.
    


Intervention name(s): induction of urge by rectal distension
Intervention type(s): Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
HIPEC After Radical Cystectomy for High Risk Bladder Cancer
Condition: Invasive Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms
Study type: Interventional

Summary: 
      This is a non-randomized, non-blinded, pilot study administering hyperthermic intraperitoneal
      chemotherapy with Mitomycin-C in 10 men and women with muscle-invasive urothelial carcinoma
      of the bladder undergoing radical cystectomy with pelvic lymph node dissection who have risk
      factors for tumor recurrence.
    


Intervention name(s): HIPEC
Intervention type(s): Procedure
Intervention description(s): 40mg of Mitomycin-C dissolved in 100ml normal saline will be added into the perfusate and instilled into the patient for a total of 60 minutes. After 60 minutes, the abdomen will be irrigated with 3 liters of normal saline.
Other intervention name(s): Hyperthermic intraperitoneal chemotherapy
Intervention model: Single Group Assignment
Intervention model description: HIPEC with Mitomycin-C
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: High-risk bladder cancer; Urothelial cancer; HIPEC; Mitomycin
Study to Evaluate DT-216 in Adult Patients With Friedreich Ataxia
Condition: Friedreich Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia; Friedreich Ataxia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic and
      pharmacodynamic effects of intravenous DT-216 in adult patients with Friedreich Ataxia. This
      single ascending dose study is randomized, double-blind, placebo-controlled.
    


Intervention name(s): DT-216; DT-216 matching Placebo
Intervention type(s): Drug; Drug
Intervention description(s): DT-216 will be administered by intravenous (IV) injection; Placebo will be administered by intravenous (IV) injection
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Primary Prevention of Hypertension in Obese Adolescents
Condition: Obesity; Pre-Hypertension; Hyperuricemia
MeSH terms: Hypertension; Prehypertension; Hyperuricemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to examine the consequences of lowering serum uric acid in
      pre-hypertensive, obese adolescents pathways involved with how uric acid mediated
      hypertension and renal disease. The specific aims are:

        1. Test the hypothesis that lowering uric acid will improve endothelial function.

        2. Test the hypothesis that lowering uric acid will reduce plasma renin activity and serum
           angiotensin II levels.

        3. Test the hypothesis that lowering uric acid will reduce markers of inflammation
    

Detailed description: 
      The trial will be a double blinded, placebo control trial of two uric acid lowering agents.
      The endpoints for this trial will be, endothelial function, systemic vascular resistance,
      plasma renin activity, MCP-1 and CRP. Upon recruitment and informed consent, children will
      undergo initial screening. This will include medical history, family history, dietary
      history, review of systems (questionnaire used and validated in pediatric hypertension
      clinic) and pediatric quality of life questionnaire. They will have a physical exam, casual
      and ambulatory blood pressure monitoring (see below) and screening laboratory analysis that
      will include CBC, electrolytes, BUN, Cr, Uric acid, AST, ALT and urinary micro-albumin to
      creatinine ratio. Children with serum uric acid less than 5.0mg per dl will be enrolled as
      controls and only have baseline studies at Screening and Visit 1. Children with serum uric
      acid equal to or greater than 5.0mg per dl will be randomized (in a one to one to one ratio)
      to receive placebo, allopurinol or probenecid.

      Study drug (or placebo) will be administered for 2 months. During the first week, subjects
      will take one tablet (placebo, 150mg allopurinol or 250mg probenecid) twice daily. At the end
      of one week subjects will be instructed to increase to 2 tablets (placebo, 300mg allopurinol
      or 500mg probenecid) twice daily. Data collection will occur during screening, after one and
      two months on the study drug and one month after completion of the study drug.
    

Intervention name(s): Allopurinol; Probenecid; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Allopurinol; Probenecid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Neuromodulation of Aspiration Secondary to Stroke
Condition: Deglutition Disorders
MeSH terms: Deglutition Disorders
Study type: Observational

Summary: 
      Aspiration could induce major respiratory affection. They are often present after stroke. The
      aim of this study is to facilitate swallowing recuperation in stroke patients using
      peripheral laryngeal stimulation and to understand its mechanisms using motor evoked
      potential and cortical evoked potential.
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        stroke patients
      
Keywords: aspiration; stroke; motor evoked potential; cortical evoked potential; neuromodulation
Program of Supervised Occlusive Aerobic Training in People With Fibromyalgia.
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      Occlusive training in people with fibromyalgia
    

Detailed description: 
      Intervention study in people with fibromyalgia with the implementation of a lower body
      occlusive tool in aerobic exercise. The study aims to descriptively test the impact on
      quality of life and functional autonomy of occlusive training in a controlled and
      individualized way in two groups: group 1 aerobic exercise with use of occlusive tool and
      group 2, aerobic exercise without occlusive tool in a period of 9 weeks twice a week.
    

Intervention name(s): Occlusion training
Intervention type(s): Device
Intervention description(s): Impact of supervised occlusive training for 2 days per week for 10 weeks on quality of life and functional autonomy in participants with fibromyalgia.
Other intervention name(s): Occlusive cuffing during aerobic exercise in participants with fibromyalgia
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Group 1: Aerobic exercise plus occlusive tool. Group 2: Aerobic exercise without occlusive tool.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: occlusive training
Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis With Clofazimine (C)-TMC207 (J)-PA-824 (Pa)-Pyrazinamide (Z)
Condition: Pulmonary Tuberculosis
MeSH terms: Tuberculosis; Tuberculosis, Pulmonary
Study type: Interventional
Phase: Phase 2

Summary: 
      The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral
      administration of TMC207 plus PA-824 plus Pyrazinamide plus Clofazimine, TMC207 plus PA-824
      plus Pyrazinamide, TMC207 plus PA-824 plus Clofazimine alone, TMC207 plus Pyrazinamide plus
      Clofazimine, Pyrazinamide alone, Clofazimine alone, and standard first line TB treatment as
      per South African TB Guidelines (Rifafour e-275) as determined by the rate of change of log
      CFU per ml sputum over the time period Day 0-14 in participants with smear positive pulmonary
      tuberculosis (TB). A control group will receive standard treatment.
    


Intervention name(s): TMC207 (J); PA-824 (PA); pyrazinamide (Z); clofazimine (C); Rifafour
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): TMC207 400 mg Day 1; 300mg Day 2; 200mg Days 3-14; PA-824 200mg Days 1-14; 1500mg Days 1-14 Dosed by Weight; clofazimine 300mg Days 1-3 and clofazimine 100mg Days 4-14; Rifafour e-275 mg dosed by weight
Intervention MeSH terms: Pyrazinamide; Clofazimine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tuberculosis; EBA; PA824; pretomanid; TMC207
PK/PD Comparison of Guanfacine ER and IR
Condition: Smoking
Study type: Interventional
Phase: Phase 2

Summary: 
      Evaluate whether a 4mg/day or 6/mg day dose of extended-release guanfacine produces
      pharmacokinetic/dynamic (PK/PD) properties similar to 3mg/day immediate release guanfacine.
    


Intervention name(s): Guanfacine
Intervention type(s): Drug
Intervention description(s): 3mg/day IR with 3-week lead-in period. Maintained at steady state to complete lab session. After completion of lab session, 1-week lead-in medication period to 4mg/day ER. Maintained at steady state to complete lab session. After completion of lab session, 1-week lead-in medication period to 6mg/day ER. Maintained at steady state to complete lab session. 5-day taper after lab.
Other intervention name(s): Tenex; Intuniv
Intervention MeSH terms: Guanfacine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Guanfacine; PK/PD; Smokers
Safety And Efficacy Of 12 Weeks Of Varenicline For Smoking Cessation In Smokers With Depression
Condition: Smoking Cessation; Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients with depression tend to have a higher prevalence of smoking as well as increased
      severity of nicotine dependence. Phase 2 and Phase 3 varenicline clinical trials that
      demonstrated its efficacy and tolerability have not included subjects with depression. This
      smoking cessation study focuses on the depressed population and will assess the efficacy and
      safety of varenicline.
    


Intervention name(s): varenicline; placebo
Intervention type(s): Drug; Drug
Intervention description(s): varenicline tablets titrated to 1 mg BID during 1st week and then 1 mg BID for 11 weeks; placebo tablets matched in appearance and dosage to varenicline tablets
Other intervention name(s): Champix/Chantix
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: smoking; smoking cessation; smoking cessation in depressed subjects
Comparing Absorption of Dietary Phosphorus When Administering FOSRENOL® or RENVELA® in Healthy Adult Volunteers
Condition: Kidney Failure, Chronic
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the absorption of dietary phosphorus following a
      single dose with lanthanum carbonate (1000mg) and a single dose of sevelamer carbonate
      (2400mg).
    


Intervention name(s): Lanthanum Carbonate; Sevelamer
Intervention type(s): Drug; Drug
Intervention description(s): 1 x 1000mg tablet; 3 x 800mg tablets
Other intervention name(s): Fosrenol; Renvela
Intervention MeSH terms: Sevelamer
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Vascular Endothelial Protection Effects of Dextromethorphan
Condition: Atherosclerosis; Smoking; Inflammation
MeSH terms: Atherosclerosis; Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      To test the hypothesis that DM could have anti-inflammatory effect and thus achieve vascular
      protection effect on heavy smokers.
    

Detailed description: 
      Dextromethorphan (DM), an ingredient widely used in antitussive remedies, had been reported
      to reduce the inflammation-mediated degeneration of neurons. We recently found that DM can
      prevent vascular remodeling and neuron injury in animal models of carotid ligation and
      cerebral ischemia injuries, respectively. It was believed that its action was through the
      anti-oxidant and NADPH pathway to protect brain cells. However, the mechanism and actual
      effect on human vascular protection remained unclear.

      To test the hypothesis that DM could have anti-inflammatory effect and thus achieve vascular
      protection effect on heavy smokers, this prospective study will be conducted to treat
      subjects with heavy smoking history with DM or not and evaluate the anti-inflammatory and the
      improvement of endothelial function.
    

Intervention name(s): Dextromethorphan
Intervention type(s): Drug
Intervention description(s): 120 mg/day, single once daily dose taken after breakfast by oral route
Other intervention name(s): medicon for DM
Intervention MeSH terms: Dextromethorphan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: endothelial function; atherosclerosis; smoking; inflammation; antioxidant
Probiotics in Respiratory Tract Infections in Children
Condition: Infections, Respiratory Tract
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the potential of probiotics in prevention of
      respiratory tract infections and their complications in children
    


Intervention name(s): L. acidophilus DDS-1, B. lactis UABLA-12; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1 g of probiotic will be reconstituted in 25-50 ml tepid water, juice or age specific baby food and immediately fed once a day (5 billion CFU/daily) for 2-weeks trial period or to the end of acute respiratory infection depending on whatever is longer.; 1 g in 25-50 ml of tepid water or juice fed once a day for 2-weeks trial period or to the end of acute respiratory infection depending on whatever is longer.
Other intervention name(s): DDS-Junior; Rice maltodextrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Children; Respiratory Tract Infections; Prevention