bioihbjkbjnl/mcl2 huggingface dataset:
Feasibility of an Interval Exercise and Nutrition Intervention to Reduce Cardiovascular Disease Risk Factors
Condition: Pre-Diabetic; Overweight; Obesity
MeSH terms: Cardiovascular Diseases; Overweight
Study type: Interventional

Summary: 
      Purpose : Test the feasibility (acceptability, adherence) of a home-based interval exercise
      training (IET) and nutrition program, as well as its preliminary effects on resting heart
      rate, blood pressure, fasting glucose, HDL, cholesterol, weight and percent body fat, among
      primary care patients who have at least one risk factor for cardiovascular disease (CVD).

      Participants : 30 patients who receive care from the University of North Carolina (UNC)
      Family Medicine Center (FMC) and meet the inclusion criteria defined below (i.e. general FMC
      patients, not diagnosed with severe illness), will be enrolled to test the feasibility of the
      home-based interval exercise and nutrition program.

      Procedures (methods): A home-based IET and nutrition program will be piloted in 2 phases. In
      Phase I, 15 patients will be enrolled into the program, which will take approximately 3
      months. At baseline, data will be collected on age, height, weight, resting heart rate, blood
      pressure, fasting glucose, hemoglobin A1c, fasting lipids, cholesterol, insulin, percent body
      fat, cardiovascular fitness, and use a series of questionnaires to evaluate mood, sleep,
      hunger, and quality of life. At closeout, the investigators will measure patients' adherence
      to each component of the intervention. In Phase II, an additional 15 new patients will be
      enrolled in either the identical protocol, or a slightly modified intervention (if necessary
      based upon our results from Phase I). All patients will have the same variables measured at
      baseline during their study visit at 3, 6 and 12 months after enrollment into the study.
    


Intervention name(s): Exercise & Dietary Supplement
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: feasibility studies; intervention; Pre-Hypertensive; Pre-Hyperlipidemia
A Study to Compare Tenofovir Disoproxil Fumarate Versus Adefovir Dipivoxil for the Treatment of HBeAg-Negative Chronic Hepatitis B
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      This primary objectives of this study are to compare the efficacy, safety, and tolerability
      of tenofovir disoproxil fumarate (TDF) versus adefovir dipivoxil (ADV) for the treatment of
      pre-core mutant chronic hepatitis B. Participants will receive TDF or ADV for 48 weeks
      (double-blind). After 48 weeks, eligible participants switched to open-label TDF for up to
      480 weeks.
    


Intervention name(s): TDF; ADV; TDF placebo; ADV placebo; FTC/TDF
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 300 mg tablet administered orally once daily; 10 mg tablet administered orally once daily; Tablet administered orally once daily; Tablet administered orally once daily; 200/300 mg fixed-dose combination (FDC) tablet administered orally once daily
Other intervention name(s): Viread®; Hepsera®; Truvada®
Intervention MeSH terms: Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Adefovir dipivoxil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tenofovir; adefovir; hepatitis B virus; HBeAg Negative
Atenolol Exposure as Risk for Adverse Metabolic Responses to Beta Blockers
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The researchers hypothesize that the impact of increasing systemic exposure to atenolol leads
      to increased risk for adverse metabolic effects from atenolol therapy in hypertension. This
      will be accomplished through a 24-hour pharmacokinetic (PK) study and oral glucose tolerance
      test in hypertensive patients taking chronic atenolol 100 mg daily.
    

Detailed description: 
      The current study is a sub-study of Pharmacogenomic Evaluation of Antihypertensive Responses
      (PEAR - NCT00246519). The primary objective of this pharmacokinetic (PK) study is to
      investigate the correlation of atenolol Cp with hypertriglyceridemia and insulin sensitivity
      in mild to moderate hypertensive patients after 6-8 weeks of atenolol treatment.

      Participants will undergo the PK study when they have been on atenolol 100 mg once daily for
      at least 4 weeks and on atenolol therapy (50 mg or 100 mg) for ≥ 7 weeks. They will undergo a
      two hour Oral Glucose Tolerance Test (OGTT), 1 hour after atenolol dosing. Blood will be
      drawn at 12 time points for 24 hours. Atenolol Cp will be measured in all 12 blood samples
      and will be correlated with the glucose/insulin measured during the OGTT.
    

Intervention name(s): Glucose
Intervention type(s): Other
Intervention description(s): Oral Glucose Tolerance Test
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Keywords by National Institute of General Medical Sciences; Hypertension; Adverse metabolic effects; Beta blockers; Dyslipidemia; Atenolol; New onset diabetes; Pharmacokinetic study; Oral glucose tolerance test
Myo-inositol/D-chiro-inositol Ratio in Follicular Fluid
Condition: Women Infertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      Considering the importance assumed by follicular microenvironment for a proper oocyte
      development, this study is a prospective observational clinical trial which aims to evaluate
      whether the embryo blastocyst quality may be affected by different Myo-inositol (MI) and
      D-chiro-inositol (DCI) levels in the follicular fluid (FF) of the aspired oocytes. The study
      includes egg donors and egg receiving couples participating in the oocyte donation program.
      MI/DCI is calculated in FF and related with blastocyst grade.
    


Intervention name(s): Dosage of myo-inositol; Dosage of D-chiro-inositol
Intervention type(s): Other; Other
Intervention description(s): Quantitative analysis of myo-inositol was performed by gas chromatography-mass spectrometry (GC-MS); Quantitative analysis of D-chiro-inositol was performed by gas chromatography-mass spectrometry (GC-MS)
Intervention MeSH terms: Inositol
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study included 8 egg donors participating in the donation program of IAKENTRO not for
        the first time, and 11 recipient couples undergoing in vitro fertilization (ICSI).

        Follicular fluid (FF) specimens were analysed.
Perfusion Assessment With Indocyanine Green-SPY Angiography After Tissue Expander Filling
Condition: Tissue Expander Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to optimize the expansion pressure by compare different capsule
      pressures' effect, the blood supply of expanded skin is assessed by the Indocyanine Green-SPY
      Angiography.
    

Detailed description: 
      This is a randomized controlled trial that designed to optimize the tissue expander expanding
      method. All the patients were randomly divided into five groups, patients in different groups
      received an expansion weekly with different capsule pressure of 60mmHg, 70mmHg, 80mmHg,
      90mmHg and 100mmHg respectively. Each patient received an expanding once a week, and a
      hemodynamic assessment of SPY-ICG angiography every two weeks. The total follow-up for each
      patient is 8 weeks.
    

Intervention name(s): 60mmHg capsule pressure expansion; 70mmHg capsule pressure expansion; 80mmHg capsule pressure expansion; 90mmHg capsule pressure expansion; 100mmHg capsule pressure expansion
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): With a self-made apparatus composed of a spring-loaded sphygmomanometer and a disposable three-way pipe, the capsule pressure is measured. Increasing capsule pressure till 60mmHg.; With a self-made apparatus composed of a spring-loaded sphygmomanometer and a disposable three-way pipe, the capsule pressure is measured. Increasing capsule pressure till 70mmHg.; With a self-made apparatus composed of a spring-loaded sphygmomanometer and a disposable three-way pipe, the capsule pressure is measured. Increasing capsule pressure till 80mmHg.; With a self-made apparatus composed of a spring-loaded sphygmomanometer and a disposable three-way pipe, the capsule pressure is measured. Increasing capsule pressure till 90mmHg.; With a self-made apparatus composed of a spring-loaded sphygmomanometer and a disposable three-way pipe, the capsule pressure is measured. Increasing capsule pressure till 100mmHg.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a prospective randomized controlled trial.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: SPY-ICG Angiography; Tissue Expander; Capsule Pressure; Blood Supply
Effect and Safety of Electroacupuncture for Symptoms of Menopausal Transition
Condition: Menopausal Syndrome
Study type: Interventional

Summary: 
      The primary object is to evaluate the efficacy and safety of electroacupuncture for symptoms
      of women during menopausal transition .
    

Detailed description: 
      Menopause transition is called perimenopause in the past time. 40-80% women aged 40 to 65
      have symptoms during this period. Hormone therapy is the recommended therapy for menopause
      and there is not enough evidence in favor of alternative medicine's effect.

      Our pilot trial showed that electroacupuncture had better effect for menopause transition
      symptoms than sham electroacupuncture. We are going to conduct a phase Ⅱ clinical trial to
      further evaluate the safety and effect of electroacupuncture for menopause transition
      symptoms.
    

Intervention name(s): electroacupuncture; sham electroacupuncture
Intervention type(s): Other; Other
Intervention description(s): Stick adhesive tapes to all points. For ST25, EX-CA1 and RN4, insert the needle vertically through the pads and the skin, and then slowly and vertically penetrate through the layer of fatty tissue, into the muscles of the abdominal wall .For RN4, manipulate the needle with an even lifting, thrusting and twisting method slightly for 3 times. Insert the needle vertically at SP6 to a depth of 1 cm. Manipulate the needle with an even lifting, thrusting and twisting method slightly for 3 times to reach de-qi. Put the electric stimulator on the pair of EX-CA1 and ST25 points with a dilatational wave, 10/50 Hz, 0.5-1.0mA. To turn on the current intensity till the abdomen shivers. The same manipulation methods for RN4 and SP6 will be given every 10 minutes (3 times in all).; Non-points proximate to RN4 (P1), EX-CA1(P2)，ST25 (P3) and SP6 (P4) (double sides) are used.P1 and P3 are at the sites 1 cm (outward in horizontal direction) proximate to RN4 and ST25 respectively. P2 is 2 cm (outward in horizontal direction) proximate to EX-CA1. P4 is at the middle site of the spleen meridian and the kidney meridian (backward in horizontal direction proximate to SP6).
Stick adhesive tapes to all points. Blunt needles will be used to be inserted to but not piercing the skin. Even lifting, thrusting and twisting manipulation methods will be given for each non-point for 3 times. Put the sham electric stimulator on the pair of P2 and P3 with the same parameters as the acupuncture group. But there is no current intensity actually.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Semilunar Coronally Positioned Flap With or Without Enamel Matrix Derivative for the Treatment of Gingival Recessions
Condition: Gingival Recession
MeSH terms: Gingival Recession
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study will be evaluate clinically the use of the Semilunar Coronally
      Positioned Flap (SCPF) for the treatment of gingival recessions, with or without Enamel
      Matrix Derivative (EMD). Thirty patients will be assigned in two groups. Half of patients
      will receive EMD associated to SCPF, while the other half, will receive SCPF alone.
    

Detailed description: 
      The aim of this study will be evaluate clinically the use of the Semilunar Coronally
      Positioned Flap (SCPF) for the treatment of gingival recessions, with or without Enamel
      Matrix Derivative (EMD). Thirty patients will be selected, randomized and allocated in two
      groups: test group (SCPF + EMD) and control group (SCPF). The subjects will should present
      buccal Miller class I gingival recessions with height greater than or equal to 2.0 mm and
      less than to 4.0 mm in maxillary canines or premolars. Clinical parameters will be evaluated:
      gingival recession height (GRH), gingival recession width(GRW), clinical attachment level
      (CAL), probing depth (PD), height (HKT) and thickness (TKT) of keratinized tissue and
      papillas height (HP) and width(LP), as well as plaque and gingival index. These data will be
      collected at baseline and 180 days after surgery.
    

Intervention name(s): Semilunar coronally positioned flap; Enamel matrix derivative (Emdogain)
Intervention type(s): Procedure; Device
Intervention description(s): Semilunar coronally positioned flap with enamel matrix derivative (Emdogain) or alone.; Enamel matrix derivative associated to semilunar coronally positioned flap (SCPF + EMD - test group)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Gingival Recession; Semilunar flap; Enamel matrix derivative; Periodontal regeneration
Examining The Effect Of Ketamine On Glutamate/Glutamine Cycling
Condition: Depression
MeSH terms: Depression
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study is looking at the mechanisms underlying the behavioral effects of ketamine in
      healthy and depressed individuals.
    


Intervention name(s): Ketamine
Intervention type(s): Drug
Intervention MeSH terms: Ketamine
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
A Phase 1 Study of CDX-0159
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to determine the safety of CDX-0159 in healthy subjects.
    

Detailed description: 
      CDX-0159 is a humanized monoclonal antibody that binds to a protein called KIT that is
      expressed on mast cells.

      This study will evaluate the safety, pharmacokinetics, and pharmacodynamics of CDX-0159 in
      healthy subjects.
    

Intervention name(s): CDX-0159; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of one of four dosages of CDX-0159; Single infusion of normal saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: CDX-0159
Exercise Intervention on Conflict Monitoring in Children With Attention-deficit Hyperactivity Disorder
Condition: Exercise Intervention
Study type: Interventional

Summary: 
      The study mainly investigates the effect of high-intensity interval training on conflict
      monitoring in children with ADHD by using event-related potential and sLORETA techniques.
    

Detailed description: 
      The present study will have two experiments, one is a cross-section study and the other is
      intervention study.

      As for cross-section study, typical developmental children and children with ADHD will
      perform the stroop task while recording their brain waves.

      The intervention is twice a week for 5 weeks and before and after the intervention, children
      with ADHD will randomly assign to either an exercise group or control group. They will
      perform the stroop task while recording their brain waves.
    

Intervention name(s): High-intensity interval training
Intervention type(s): Other
Intervention description(s): 2 times weekly for 5 weeks Circuit training with 4 stations
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: HIIT; executive function; ADHD; chronic exercise
Safety and Effectiveness of Subconjunctival Injection of Bevacizumab in the Treatment of Corneal Neovasculization
Condition: Lipid Keratopathy; Penetrating Keratoplasty; Herpetic Keratopathy; Rosacea
MeSH terms: Rosacea
Study type: Interventional

Summary: 
      1. Purpose:Our animal study demonstrated the effectiveness of subconjunctival injection of
           bevacizumab in the inhibition of corneal neovasculization formation. The purpose of this
           human interventional study is to report the treatment outcome of subconjunctival
           injection of bevacizumab in patients with corneal neovascularization.

        2. Material and methods: We enrolled 13 patients with unilateral or bilateral clinically
           significant corneal neovascularization during Aug. 2007 to Jan. 2008. Subconjunctival
           injection of bevacizumab once per month for at most 7 times was performed according to
           clinical response.

        3. Main outcome measurements: resolution of corneal neovascularization, reduction of lipid
           infiltrate, improved visual acuity.
    


Intervention name(s): subconjunctival injection of bevacizumab ( 1.25 to 2.50 mg)
Intervention type(s): Drug
Intervention description(s): subconjunctival injection of bevacizumab ( 1.25 to 2.50mg) according to the clinical judgment. Once per months for three times then reevaluate the drug effect, if the response was adequate, stop the trial; if no improvement, another three month intervention would be performed.
Other intervention name(s): bevacizumab ( Avastin )
Intervention MeSH terms: Bevacizumab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: corneal neovascularization; lipid keratopathy; penetrating keratopathy; bevacizumab; Avastin; subconjunctival injection
Effect of Interscalene Block on Ventilatory Function
Condition: Respiratory Depression; Anesthesia Morbidity; Block
MeSH terms: Respiratory Insufficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      Interscalene block with local anesthetic impairs ventilation (unilateral diaphragmatic
      dysfunction). Single injection of local anesthetic induced transitory dysfunction (< 24h).
      The investigators hypothesized that continuous interscalene block would prolonged ventilatory
      impairment
    

Detailed description: 
      Unilateral pulmonary dysfunction occured after interscalene block due to phrenic nerve
      paralysis. This reduction induced vital capacity alteration and peek flow reduction.Several
      studies analysed dysfunction recovery duration after single injection using short
      (lidocaine)or intermediate (ropivacaine, bupivacaine)local anesthetic drug. Because
      continuous infusion prolonged block duration, phenic nerve may be also prolonged. However no
      study with continuous interscalene infusion have been performed for this dysfunction.
    

Intervention name(s): ropivacaine 2 mg/ml
Intervention type(s): Drug
Intervention description(s): single
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Low Intensity Shock Wave Therapy for ED in PDE5i Non Responders
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 3

Summary: 
      Low Intensity Shock Wave Therapy (LI-ESWT) was shown to have a beneficial effect on ED
      patients responding to PDE5i's. This study aimed to determine the capability of swt to
      convert PDE5 inhibitor non responders to sexually functioning males under PDE5i therapy.
    

Detailed description: 
      We included severe ED patients (60% diabetic, 85% with cardiovascular disease) that failed to
      respond to PDE5i therapy, who scored 0-2 on the rigidity scale (RS) during PDE5i
      therapy.Treatment included 2 sessions/week for 3 weeks, repeated after a 3-week no-treatment
      interval. At each session LI-ESWT was applied on the penile shaft and crus for 3 minutes in 5
      different penile anatomical sites (intensity of 0.09 mj/mm2, 300 shocks/site). One-month
      after end of treatment the same baseline assessment was repeated. An active PDE5i medication
      regime was then provided and final erectile function was reassessed. Main endpoints for
      success were changes in RS and in the International Index of Erectile Function (IIEF-ED)
      Domain score. We found that LI-ESWT can effectively treat severe ED patients who failed PDE5i
      therapy. This study further emphasises the physiological effect that LI-ESWT can have on the
      erectile mechanism.
    

Intervention name(s): LI-ESWT
Intervention type(s): Device
Intervention description(s): Low intensity shock wave treatment - 12 sessions
Other intervention name(s): Omnispec model ED1000
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: LI-ESWT; Erectile Dysfunction; Non PDE5 inhibitor responders; Shock wave
The Effect of Guided Imagery on the Third Stage of Labor
Condition: Third Stage of Labor; Bleeding; Guided Imagery; Childbirth
MeSH terms: Hemorrhage
Study type: Interventional

Summary: 
      The purpose of this study was to evaluate the effect of guided imagery on the third stage of
      labor. Blood loss from hemorrhage during childbirth, most commonly due to uterine atony, is
      one of the leading causes of maternal mortality in the United States and the leading cause of
      maternal death worldwide. The hypothesis was that the use of physiologic guided imagery would
      reduce the amount of bleeding during the third stage of labor.
    


Intervention name(s): Guided imagery
Intervention type(s): Behavioral
Intervention description(s): A relaxation focused guided imagery intervention was used through the remainder of pregnancy plus a physiologic guided imagery intervention was used during the third stage of labor.
Primary purpose: Prevention
Keywords: third stage of labor; bleeding; guided imagery; childbirth