bioihbjkbjnl/mcl2 huggingface dataset:
Vascular Health With Immobilization and Exercise Training
Condition: Immobilization, Tonic; Physical Activity
Study type: Interventional

Summary: 
      The study includes healthy young habitually active subjects. All subjects are subjected to
      two weeks of immobilization of one leg followed by four weeks of training of both legs. The
      subjects are randomized to either one-leg training of the non-immobilized leg during the
      two-week immobilization period or to no training of the non-immobilized leg during the
      immobilization period. Measures include skeletal muscle morphology, markers of angiogenesis
      and apoptosis, muscle metabolic markers, vascular function, vascular proteins and
      performance.
    

Detailed description: 
      One leg of young healthy subjects will be immoblized for two weeks. Changes in angiogenic
      proteins and markers of apoptosis in muscle tissue and muscle extracellular fluid will be
      determined in both legs and in parallel the functional consequences of immobilization will be
      assessed. Vascular function and vascular proteins will also be determined. In order to
      understand how the oxidative capacity of the muscle is altered in parallel with changes in
      capillarization, markers of mitochondria will be measured .Half of the subjects will be
      randomized to single-leg training during the immobilization period to assess whether
      simultaneous training reduces the loss of capillaries, muscle function and vascular function
      in the immobilized leg. After the immobilization period the study participants will train the
      immobilized leg and the control leg for four weeks by moderate to intense interval cycle
      training and the same parameteres as during immobilization will be assessed in both legs. The
      study will also include measurements of circulating compounds and platelets in blood.
    

Intervention name(s): Immobilization; Training with non immobilized leg; Exercise training with both legs
Intervention type(s): Other; Other; Other
Intervention description(s): Full length cast of one leg R/L randomized; Exercise training will be conducted with the non-immobilized leg during the immobilization period of two weeks; Exercise training will be conducted regularly on a cycle ergometer during a four week period
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel randomized to training or no training of non-immobilized leg during immobilization of the other leg
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Immobilization; Angiogenesis; Skeletal muscle; Exercise training; Vascular function
Can Caudal Dexmedetomidine Prevents Sevoflurane Induced Emergence Agitation in Children
Condition: Delayed Emergence From Anesthesia
MeSH terms: Psychomotor Agitation; Emergence Delirium; Delayed Emergence from Anesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      Emergence agitation (EA) is common phenomenon in pediatric patients undergoing general
      anesthesia by inhalation agents. The incidence of EA was reported to range from 18% to 80%.
      Sevoflurane now is the inhalational anesthetic agent of choice for pediatrics, Different
      strategies have been suggested to decrease the incidence and severity of EA. No gold standard
      technique for treating EA after sevoflurane anesthesia is currently available. The main
      question is can caudal dexmedetomidine be used for this purpose?
    

Detailed description: 
      The purpose of this prospective comparative randomized clinical study will be to compare the
      effects of caudal dexmedetomidine on EA in children undergoing lower abdominal operations
      under general sevoflurane anesthesia. In addition, characteristics of anesthesia recovery and
      incidence of adverse effects will be compare. A total of (48) children aged 1-5 years old,
      The American society of Anesthesiologists (ASA) physical status classification system between
      I-II of both sex who will be enrolled from April 2016 to April 2017 undergoing for lower
      abdominal surgeries will be included in the study. Patients will be randomized by
      computer-generated random numbers in a double blinded fashion to get enrolled into 2 equal
      groups: Group BD patients (n = 24) will be received single dose caudal epidural analgesia
      using dexmedetomidine with bupivacaine, whereas Group B patients (n = 24) will be received
      single dose caudal epidural analgesia with bupivacaine only. The dexmedetomidine used for
      this study will be prepared in a 1 ml syringe wrapped in aluminum foil by an investigator who
      will not be involved in the anesthesia process and another 1 ml syringe filled with saline
      will be prepared too.
    

Intervention name(s): Dexmedetomidine
Intervention type(s): Drug
Intervention description(s): Single dose caudal epidural injection will be done using 25 G needle. patients of Group BD will be given dexmedetomidine (precedex 100 µg/mL parenteral preparation (Hospira ® ) 2 µg/kg in 1 ml/kg bupivacaine 0.25%,
Other intervention name(s): Precedex
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: sevoflurane emergence agitation; caudal dexmedetomidine
GS-5885 Alone or in Combination With GS-9451 With Peginterferon Alfa 2a and Ribavirin in Treatment Chronic Genotype 1 Hepatitis C Virus
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response
      Guided Therapy with GS-5885 Alone or in Combination with GS-9451 with Peginterferon Alfa 2a
      and Ribavirin in Treatment Naïve Subjects with Chronic Genotype 1 Hepatitis C Virus
      Infection.
    


Intervention name(s): GS-5885; GS-9451; peginterferon alfa-2a; ribavirin tablet; GS-9451 Placebo
Intervention type(s): Drug; Drug; Biological; Drug; Drug
Intervention description(s): tablet, 30 mg QD; tablet, 200 mg QD; (solution for injection) 180 µg/week; ribavirin tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID); Placebo to match GS-9451 QD
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a; Ledipasvir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hepatitis C; HCV; Rapid Virologic Response; Sustained Virologic Response; Direct Acting Antiviral; Combination Therapy HCV RNA; Protease inhibitor; Treatment naïve; GS-5885; GS-9451
A Pap Test Intervention to Enhance Decision Making Among Pacific Islander Women
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      This community-based randomized trial tested the effects of a social support intervention to
      increase Chamorro, Samoan, and Tongan women's Pap test behavior and social support among
      their male spouses or significant others in Southern California.
    

Detailed description: 
      The purpose of this five-year community-based randomized trial was to: 1) examine the Pap
      test decision making process in Pacific Islander women; 2) assess the role of social support
      within the decision making process; and 3) develop and test an intervention to increase Pap
      testing among Pacific Islander women, and support among their male spouses/significant
      others. The intervention was created utilizing a Multi-Attribute Utility model and social
      support theory resulting in gender-specific educational workshops consisting of a social
      support intervention that informed both Pacific Islander women and men about cervical cancer
      and the importance of Pap testing for Pacific Islander women, and aimed to increase social
      support among their male spouses/significant others.
    

Intervention name(s): Intervention
Intervention type(s): Behavioral
Intervention description(s): The educational session consisted of a one-hour small group discussion (5-10 people). Gender-specific community health educators facilitated sessions for Pacific Islander women and for their spouses/significant others that included an educational video and other materials (brochure, calendar, and resource list). The video emphasized the importance of Pap testing for Pacific Islander women, and showed men supporting their women to get tested. Women's sessions provided basic information on cervical cancer and pap testing, and ended with verbal commitments and target screening dates by women to get screened. The men's education sessions contained similar information, with supplemental information on how to provide support for their wives to get tested and exercises on showing their support.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Cervical Cancer; Screening; Pap Test; Pacific Islander Americans
Position of Esophageal Balloon in Patients With Mechanical Ventilation
Condition: Mechanical Ventilation
Study type: Observational

Summary: 
      Transpulmonary pressure is frequently monitored in patients with mechanical ventilation.
      Right position of the catheter balloon is the key factor in accurate measurement. A simple
      method for confirming the balloon position will be validate in this study.
    

Detailed description: 
      Transpulmonary pressure, which is the pressure at the airway opening minus pleural pressure,
      is frequently monitored in patients with mechanical ventilation. Because pleural pressure is
      difficult to measure in most clinical situations, esophageal pressure (Pes) is used as a
      surrogate. Catheter with air balloon is the most commonly used method to measure the Pes.
      Right position of the balloon is the key factor in accurate measurement of Pes, and the lower
      third part of esophagus is recommended as the target position of the balloon. The catheter is
      usually inserted into the stomach first, and then slowly withdrawn into the esophagus after
      inflation of the balloon. A negative pressure deflection replacing the positive pressure
      deflection during inspiration generally indicates the balloon's entering into the esophagus.
      This confirmation method depends on the normal function of diaphragm. However, it may not
      always be possible to obtain the standard pressure deflections in patients with mechanical
      ventilation, especially in those with diaphragmatic paralysis.

      In present study, the investigators developed a simple method to confirm the balloon position
      by using a modified SmartcathG esophageal balloon catheter. The objective was to evaluate the
      validity of this method and to investigate the relationship between the cardiac artifacts of
      the Pes tracings and the position of the balloon.
    

Intervention name(s): Esophagus balloon catheter insertion.
Intervention type(s): Procedure
Intervention description(s): Esophagus balloon catheter will be inserted and the position of the balloon will be confirmed by a air injection test.A bolus of 30 ml of air was injected to the gastric lumen of the catheter just next to the distal edge of the balloon, during the onset of end-expiratory phase. The presence of a positive disturbing wave (PDW) in esophageal pressure waveform to this air injection will be the indicator of the right balloon position.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adult patients with mechanical ventilation.
      
Keywords: mechanical ventilation; esophageal pressure; catheter position; validation
Phase III Study of DA-3031(PEG-G-CSF) in Chemotherapy-induced Neutropenia
Condition: Chemotherapy Induced Neutropenia
MeSH terms: Neutropenia
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is to determine whether once-per-cycle DA-3031(PEG-G-CSF) is not inferior to daily
      G-CSF in chemotherapy-induced neutropenia.
    

Detailed description: 
      Eligible subjects are randomly assigned to receive once-per-cycle DA-3031(PEG-G-CSF) or daily
      G-CSF(up to 10 days). This study is conducted for 6 cycles of chemotherapy, that each cycle
      is repeated every 21 days.
    

Intervention name(s): PEG-G-CSF; G-CSF
Intervention type(s): Drug; Drug
Intervention description(s): Prefilled syringe, 6mg/day, single dosing per cycle, for 6 cycle; Vial, 100ug/m2/day, multiple dosing per cycle(daily administration, up to 10 days), for 6 cycle
Other intervention name(s): DA-3031; Leucostim®
Intervention MeSH terms: Lenograstim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PEG-G-CSF
Measuring Ability of Healthy Volunteers to Power a Bicycle-powered Oxygen Concentrator
Condition: Physical Exertion
Study type: Observational

Summary: 
      The investigators would like to test how well healthy human volunteers power a modified
      oxygen concentrator. The investigators modified the oxygen concentrator to be powered by a
      bicycle instead of wall power so that it can be used in low resource countries where the
      power supply is unreliable.
    

Detailed description: 
      The investigators would like to test how many healthy people can power the oxygen
      concentrator by pedaling the bike for at least 30 minutes. If the healthy volunteers can bike
      for at least 30 minutes, the investigators assume they are pedaling at or below their lactate
      threshold. The investigators have literature values which suggest bigger people should be
      able to output more work, and the investigators wish to use a sample of the population to
      verify that most of the people can power our system. The investigators have a good estimate
      of the power required by our system, and the investigators want to verify the average person
      can actually do what we calculated is necessary.
    

Intervention name(s): Volunteer to pedal a bicycle
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy volunteers
Improved Breast MRI With SWIFT
Condition: Breast Cancer
Study type: Interventional

Summary: 
      Today's medical imaging methods have insufficient specificity for reliable differentiation
      between benign and malignant breast lesions in patients. Pathologic evaluation is currently
      the only way to obtain a definitive diagnosis. This research will use a novel method of
      magnetic resonance imaging (MRI), Sweep Imaging with Fourier Transform (SWIFT), at a very
      high magnetic field (4 Tesla) to distinguish malignant from benign breast lesions. This
      research will reveal whether the SWIFT sequence bears new capabilities in medical imaging for
      breast cancer diagnosis.
    

Detailed description: 
      Patients will be asked to come to the Center for Magnetic Resonance Research (CMRR) at the
      University of Minnesota. Researchers will interview the patient and describe procedures and
      risks. An intravenous (IV) line will be placed in an upper extremity for infusing magnetic
      resonance imaging (MRI) contrast dye. Baseline MRI scans will be done. These MRI measurements
      will be compared with clinical, radiological and pathological findings (the gold standard).

      Follow-up contact will occur within one year after the MRI to determine whether a pathology
      report is available.
    

Intervention name(s): Magnetic resonance imaging
Intervention type(s): Device
Intervention description(s): Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:
an IV line is placed by nurse,
patient is placed in the 4 T MRI scanner at CMRR,
initial scout images and manual linear shims are adjusted,
Pre-contrast SWIFT T1 weighted images and T1 map are obtained,
continuous SWIFT acquisition begins immediately before contrast injection,
contrast injection,
continuous SWIFT acquisition continues for 12 min after contrast,
late enhancement images may also be obtained.
10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compared to prior FLASH-DCE methods.
Other intervention name(s): SWIFT
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Bioequivalence of Two Formulations of Acyclovir
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      Bioequivalence of two formulations of Acyclovir (Acyclovir Lyophilized I.V. infusion 250mg)
      after Intravenous Infusion in Healthy Volunteers.
    


Intervention name(s): Acyclovir
Intervention type(s): Drug
Intervention MeSH terms: Acyclovir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Volunteers
Low vs. Standard Dose CT for Appendicitis Trial
Condition: Appendicitis
MeSH terms: Appendicitis
Study type: Interventional

Summary: 
      To determine whether low-dose (LD) CT is noninferior to standard-dose (SD) computed
      tomography (CT) as the first-line imaging test in adolescents and young adults in regard to
      negative appendectomy rate (NAR).
    

Detailed description: 
      -  Acute appendicitis is a very common disease. Many patients are adolescents or young
           adults.

        -  CT is the current standard imaging test for the diagnosis of appendicitis.

        -  In recent years, the awareness of carcinogenic risk associated with CT radiation has
           increased.

        -  According to a recent single-institutional randomized controlled trial, LD CT (employing
           a quarter of standard radiation dose) was found to be noninferior to SD CT with respect
           to NARs in adolescents and young adults with suspected appendicitis.

        -  However, LD CT is not yet widely accepted.

        -  To establish LD CT as the first-line imaging test, a multi-institutional study is needed
           to confirm the generalizability of the prior single-institutional study.
    

Intervention name(s): Diagnostic CT with low-dose radiation; Diagnostic CT with standard-dose radiation
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Effective dose is aimed at approximately 2 millisievert (mSv) in an average patient.; Effective dose is aimed at approximately 8 millisievert (or less) in an average patient.
Other intervention name(s): Low-dose CT; Standard-dose CT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Appendectomy; Appendicitis; False Positive Reactions; Humans; Radiation Dosage; Tomography, X-Ray Computed; Young Adult
Effect of a Low Calorie Diet Containing Nuts on Systemic and Vascular Inflammation
Condition: Cardiovascular Risk Factor
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      Accumulating evidence from prospective observational studies and a large clinical trial
      suggests that nut intake lowers the risk of cardiovascular disease (CVD). Tree nuts are rich
      in unsaturated fats, soluble ﬁber, antioxidants, and phytosterols. The purpose of this study
      is to compare the effects of low calorie diets with a mixture of nuts in comparison with low
      calorie diets in improving inflammatory markers in patients with stable coronary artery
      disease.
    

Detailed description: 
      A randomized placebo controlled clinical trial will be conducted in modares hospital in
      Tehran, Iran. After review of the inclusion and exclusion criteria and explanation of the
      design of the study, written consent form will be completed. The participants are 66 eligible
      patients, aged 35-70 years. Intervention group will be received low calories diets as well as
      20 percent of daily calories from mixed nuts (peanuts, pistachio and almond) and control
      group will be received low calories diets for 8 weeks. Fasting blood sample will be taken to
      measure inflammatory markers (Interleukine-6 [IL-6] and Interleukine-10 [IL-10] and
      C-Reactive Protein [CRP]).
    

Intervention name(s): Nut consumption; Low calorie diet
Intervention type(s): Dietary Supplement; Other
Intervention description(s): daily consumption of 20 percent of daily calories intake from nuts (pistachio, almond and peanuts); Low calorie diet
Other intervention name(s): Dietary Modification
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Effects of Telmisartan by Ambulatory Blood Pressure Monitoring (ABPM) in Chinese Patients With Mild to Moderate Essential Hypertension
Condition: Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess the trough/peak ratio of 40 mg Telmisartan tablet by ambulatory blood pressure
      monitoring in Chinese patients with mild to moderate essential hypertension
    


Intervention name(s): Telmisartan; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Telmisartan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment