bioihbjkbjnl/mcl2 huggingface dataset:
Treatment of Hypertension With Two Exercise Intensities
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine whether exercise training could significantly replace medication as a treatment
      for mild essential hypertension.
    

Detailed description: 
      BACKGROUND:

      Arterial hypertension affects over 50 million Americans. While drug treatment is effective,
      exercise would be safer, might be cheaper, and would bring added health benefits if it could
      replace drugs in controlling hypertension.

      DESIGN NARRATIVE:

      Randomized, controlled trial. Known hypertensives (n=162) whose diastolic blood pressures
      rose to between 90 and 104 within four months of discontinuing medication under careful
      observation had their pressures controlled with enalapril. Oxygen consumption (V02) peak was
      measured during cycle ergometry. Eligible subjects were randomly assigned to 18 months
      participation in one of three groups: 1) high intensity endurance training (35 minutes three
      times/week at heart rate at 70-85 percent of V02 peak), 2) moderate intensity endurance
      training (35 minutes three times/week at heart rate of 50-70 of V02 peak), and 3) contact
      control. Enalapril was forward or back titrated or discontinued to maintain a normal blood
      pressure. After 12 months participation, medication was withdrawn under careful supervision
      from all subjects still taking it. The trial tested the hypotheses that: 1) a greater number
      of subjects undergoing either or both of the two 18 month exercise training programs would be
      able to stop anti-hypertensive medication than non-exercising controls, 2) moderate and high
      intensity endurance training were equally effective in replacing drugs in the treatment of
      mild essential hypertension, and 3) subjects that were successful at withdrawing
      anti-hypertensive medication would have: greater improvements in V02 peak, better initial
      psychological status or greater improvements in psychological status, and greater compliance
      with the exercise training program.

      The study completion date listed in this record was obtained from the "End Date" entered in
      the Protocol Registration and Results System (PRS) record.
    

Intervention name(s): exercise
Intervention type(s): Behavioral
Allocation: Randomized
Primary purpose: Treatment
A Study Evaluating Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of HSK3486 Single Bolus Dose Followed With a 30 Minute Constant Infusion in Healthy Male Subjects
Condition: Anesthesia; Sedation
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was a single center, open-label, single dose escalation study in healthy male
      subjects to investigate a bolus dose followed by a 30 minute constant infusion of HSK3486
      over two cohorts.
    


Intervention name(s): HSK3486
Intervention type(s): Drug
Intervention model: Single Group Assignment
Intervention model description: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Assess the Bioequivalence of Different Formulations of Risedronate in Healthy Male and Female Subjects
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Randomized, double-blind, 2-treatment, 2-period, 2-sequence, crossover study, The study will
      consist of a screening visit, study center admission (preceding Treatment Periods 1 and 2), 2
      treatment periods (4 days each), 1 washout period (14 to 17 days separating periods 1 and 2),
      and exit procedures.
    


Intervention name(s): risedronate DR (Phase III clinical supply); risedronate 35 mg DR (Commercial Tablet)
Intervention type(s): Drug; Drug
Intervention description(s): Reference - (Phase III clinical supply) one 35 mg DR tablet administered as a single oral dose after an overnight (10-hour) fast, followed by a 4-hour fast; Test - (Commercial tablets) one 35 mg DR tablet administered as a single oral dose after an overnight (10-hour) fast, followed by a 4-hour fast
Other intervention name(s): Phase III clinical supply; Commercial Tablet
Intervention MeSH terms: Risedronic Acid; Etidronic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Combining Placing a Synera Patch With Propofol/Lidocaine Mixture to Decrease Pain With IV Propofol Injection
Condition: Pain on IV Injection of Propofol.
Study type: Interventional
Phase: Phase 4

Summary: 
      The main objective is to evaluate if combining placing the Synera patch and using Propofol
      /Lidocaine mixture will further decrease the pain associated with the IV injection of
      Propofol.
    

Detailed description: 
      Commonly, anesthesiologists inject Propofol, a sleeping medication, intravenously to induce
      general anesthesia.Propofol injection is commonly associated with burning pain. In a previous
      onsite study we concluded that placing a Synera patch at least 30 minutes before placing the
      IV decreased the pain associated with the Propofol injection. Also,a study documented that
      adding Lidocaine to the Propofol decreases the pain associated with propofol injection. In
      our study here we are trying to evaluate if combining the use of both the Synera patch and
      the Propofol-Lidocaine mixture will further decrease the pain associated with the IV Propofol
      injection.

      All children will receive a Synera Patch, it will be placed on the dorsum of both hands for
      at least 30 minutes.All Children will be Sedated with P.O Versed.

      22 g IV will be started either in the holding area or in the OR. Children will be randomized
      into groups using a computer generated randomization list:- Group 1 will receive Propofol
      -Lidocaine mixture. Group 2 will receive Propofol-Saline mixture. An independent blinded
      observer and an anesthesia member will independently evaluate pain on Propofol injection
      according to pain scale.

        1. No pain.

        2. Mild Pain (associated with facial expression of pain).

        3. Moderate Pain(Pulling the arm).

        4. Severe Pain (screaming).
    

Intervention name(s): Lidocaine/tetracaine transdermal patch; Saline; Lidocaine
Intervention type(s): Device; Drug; Drug
Intervention description(s): All patients in arm 1 and arm 2 will receive the Synera Patch.; Patients in arm 2 will receive Saline with the Propofol.; Patients in arm 1 will receive Lidocaine with the Propofol.
Other intervention name(s): NDC 43469-864-01; Synera Patch; 0.9% sodium chloride solution.
Intervention MeSH terms: Lidocaine; Tetracaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
SDM Laser for Non Central Diabetic CSME
Condition: Non Central Diabetic Macular Edema
MeSH terms: Macular Edema
Study type: Interventional

Summary: 
      Is to determine if SDM laser can reduce macular thickness in non central CSME and stop the
      progression of non central CSME to central CSME in compare to glycemic control
    

Detailed description: 
      interventional randomised masked study will recruit patients have diabetes mellitus with non
      central CSME with good vision into two groups : 1st SDM laser with glycemic control 2nd SHAM
      laser with Glycemic control where BCVA will be recorded every month starting from baseline to
      24 weeks where OCT will be recorded every 8 weeks from baseline to 24 weeks
    

Intervention name(s): Subthreshold 532nm laser
Intervention type(s): Device
Intervention description(s): Subthershold 532nm laser
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Lactobacillus Reuteri in Adult With Functional Chronic Constipation
Condition: Functional Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 3

Summary: 
      A double-blind, placebo Randomized Controlled Trial, To evaluate the effects of L. reuteri in
      adult patients with functional constipation.
    

Detailed description: 
      Patients affected by functional constipation according to Rome III criteria. The increase of
      Bowel Movements/week frequency was the primary outcome, while the improvement of stool
      consistency was the secondary outcome.
    

Intervention name(s): lactobacillus reuteri; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Lactobacillus reuteri (DSM 17938) was administered in the dose of 108 colony-forming units (CFU) in tablets of a commercially available preparation (Reuflor, Italchimici, Pomezia; BioGaia AB, Stockholm, Sweden), 30 minutes after feeding, twice per day for 4 weeks; a supplementation with placebo was administered in tablets of a commercially available preparation 30 minutes after feeding, twice per day for 4 weeks
Other intervention name(s): Reuflor
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of the Correlation Between Muscle Oxygenation and Motor Function in Children With Neuromuscular Disease.
Condition: Neuromuscular Diseases in Infants; Neuromuscular Diseases in Children
MeSH terms: Neuromuscular Diseases
Study type: Observational

Summary: 
      Preliminary data underline the fact that muscular deoxygenation during training happens
      earlier in adult patients suffering from neuromuscular disorders in comparison to controls.
      Up to date, pediatric data are lacking.

      The study aims at demonstrating if a correlation exists between the motor deficiency and the
      muscular deoxygenation in children suffering from neuromuscular disorders.
    

Detailed description: 
      Preliminary data underline the fact that muscular deoxygenation during training happens
      earlier in adult patients suffering from neuromuscular disorders in comparison to controls,
      as it was demonstrated in Becker muscular dystrophy patients and fascioscapulo humeral
      muscular dystrophy. Moreover, the deoxygenation kinetics was positively correlated to the
      functional status and the muscular deficiency severity. However, no pediatric study has been
      conducted on this topic up to date.

      The aim of the study is to determine if a correlation exists in children suffering from
      neuromuscular diseases:

        -  between muscular oxygenation and the percentage of the 6 minutes walking test performed
           in the routine medical care

        -  between muscular oxygenation and the total and D1 motor function measure value
    

Intervention name(s): Muscular oximetry
Intervention type(s): Other
Intervention description(s): 6 minutes walking test performed in the routine medical care with muscle oximetry recording
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        6-17 years old patients suffering from neuromuscular disorder and able to walk
Neuroproprioceptive "Facilitation, Inhibition" and Brain Plasticity
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      This study investigates whether neuroproprioceptive "facilitation, inhibition" physical
      therapy induces plastic and adaptive processes of the CNS (white matter integrity changes),
      if they relate to clinical improvement, and whether therapeutic effect differs between
      different kinds of therapies.
    

Detailed description: 
      In the Multi-Arm Parallel-Group Exploratory Trial, patients with multiple sclerosis were
      divided into three groups by an independent study coordinator, and underwent three kinds of
      neuroproprioceptive "facilitation, inhibition" physical therapy. At baseline and after the
      end of the two months' therapeutic program, a blinded assessor evaluated clinical outcomes
      and data from DTI .
    

Intervention name(s): Motor program activating therapy; Vojta's reflex locomotion; Functional electric stimulation
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Pacients underwent two months' therapy consisted of 16 face-to-face sessions (1 hour, twice a week for two months).; Pacients underwent two months' therapy consisted of 16 face-to-face sessions (1 hour, twice a week for two months).; Pacients uderwent two months' therapy. They used the whole time Functional electric stimulation during activities of daily living and underwent 2 individual sessions of Motor program activating therapy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: multiple sclerosis; physical therapy; white matter integrity; neuroproprioceptive "facilitation, inhibition"; functional recovery; network reorganization; neurohormones; dehydroepiandrosterone
A Study of LY3871801 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to compare the amount of LY3871801 that gets into the blood
      stream and how long it takes the body to get rid of it, when given as crystalline freebase
      tablet (test) and as a solid dispersion oral suspension (reference) in healthy participants.
      The information about any adverse effects experienced will be collected and the tolerability
      of LY3871801 will also be evaluated. The study may last up to approximately 15 days excluding
      the 28 days of screening period.
    


Intervention name(s): LY3871801
Intervention type(s): Drug
Intervention description(s): Administered orally.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Oesophageal Probe Evaluation in RF Ablation of Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      The Trial will evaluate the influence of oesophageal probes in Radio frequency (RF)-ablation
      of atrial fibrillation regarding oesophageal ulcers after ablation.
    

Detailed description: 
      The Trial will evaluate the influence of oesophageal probes in RF-ablation of atrial
      fibrillation regarding oesophageal complications after ablation.

      200 patients will be prospectively randomised into 2 groups. The conventional group will
      undergo RF-Ablation of atrial fibrillation using an oesophageal probe to measure the
      temperature during ablation.

      In the other group will receive ablation using fixed energy levels (25 Watt) at the posterior
      left atrial (LA) Wall without an oesophageal probe , All patients will get a gastroscopy for
      evaluation of oesophageal complications the day after the procedure.

      All patients will have a 6 months follow up (FU) in our clinic to be reevaluated for
      complications (primary endpoint) and rhythm stability. (secondary endpoint)
    

Intervention name(s): Placement of oesophageal probe for temperature measurement; Power limitation of RF generator
Intervention type(s): Device; Device
Intervention description(s): The oesophagus probe is used to measure the intraluminal temperature inside the oesophagus; no probe utilized; Limit the RF Generator Output to 25W
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: atrial fibrillation; esophageal probe; thermolesion
Effectiveness of Hypnosis Via Virtual Reality During Oocyte Retrieval
Condition: Virtual Reality Therapy; Fertilization in Vitro; Propofol; Remifentanil; Conscious Sedation
Study type: Interventional

Summary: 
      This study compares hypnosis via virtual reality to sedation with commonly used intravenous
      anesthetic agents (propofol and remifentanil) during oocyte retrieval.

      The main objective of this prospective randomized controlled study will be a reduction of 50
      percent of the doses of remifentanil and propofol administered during oocyte retrieval while
      maintaining satisfaction with the quality of care.
    

Detailed description: 
      Transvaginal ultrasound-guided oocyte retrieval is a fundamental step in the treatment of in
      vitro fertilization (IVF).

      To date, no anesthetic technique has demonstrated superiority in terms of efficacy, tolerance
      or analgesia.

      Virtual Reality Distraction has been studied for its clinical applications.

      Patients will be included during the consultation with either the gynecologist or the
      anesthetist who will explain the protocol to the patient and give her consent to sign.

      After obtaining their informed consent, the patient will be randomized into two groups based
      on a computer-generated randomization list (QuickCalcs program; GraphPad Software Inc) either
      into the experimental or in the control group.

      In the experimental group, patients will benefit from a 20-minute virtual reality. Patients
      will watch a forest walk in virtual reality while listening to narrations designed to induce
      relaxation and meditation. If the oocyte retrieval was not completed within 20 minutes, the
      patient will watch the virtual reality program again. The target-controlled infusion of
      remifentanil and propofol will be connected to the patient, and only titrated to patient's
      comfort.

      In the control group, patients will immediately benefit from an infusion of remifentanil and
      propofol titrated in a well-protocolized manner according to the patient's comfort.
    

Intervention name(s): Virtual reality distraction; Propofol-remifentanil sedation
Intervention type(s): Device; Drug
Intervention description(s): Patients will be exposed to a virtual reality representing a forest walk. A reduction of at least 50 percent in the remifentanil and propofol doses required for oocyte retrieval is expected.; Target controlled infusion (TCI) of remifentanil will be started at an effect concentration (Ce) of 1.5 ng/mL and TCI propofol at Ce 1.5 ug/mL.
The concentration of remifentanil will be adjusted in 0.5 ng/ml increments based on hand sign from the patient with a maximum effect concentration of remifentanil at 2.5 ng/ml.
Intervention MeSH terms: Remifentanil; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Myo-inositol on Human Semen Parameters
Condition: Asthenozoospermia; Oligospermia
MeSH terms: Oligospermia; Asthenozoospermia
Study type: Interventional

Summary: 
      Many clinical evidences suggest that Myo-inositol plays a crucial role in human reproduction.
      Also, it was shown that Myo-inositol concentration in the seminiferous tubules was higher
      than in serum, and interestingly it was increasing through the epididymis and the deferent
      duct mining that sperm cell before ejaculation are stored in a "medium" highly enriched in
      myo-inositol.

      Starting from this evidences, the investigators hypothesized that myo-inositol may be a
      possible factor able to improve the semen parameters of samples used in in vitro
      fertilization cycles.
    

Detailed description: 
      Samples of seminal fluid were obtained from two groups of patients undergoing to an IVF
      cycle: healthy normospermic subjects and subjects with oligoasthenoteratospermia (OAT, < 15
      mil/ml).

      Semen volume, spermatozoa number and motility were evaluated during the initial semen
      analysis and after density gradient separation method. These parameters were evaluated before
      and after the administration of 4000mg/die of myo-inositol associated to 400 µg of folic acid
      (Inofolic lolipharma Rome) for three months.

      A third group of healthy normospermic subject were traded with 400 µg of folic acid for three
      months and was consider a control group.
    

Intervention name(s): Myo-inositol normospermic; Myo-inositol OAT; Folic Acid normospermic
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 4000mg/die of myo-inositol and 400 µg of folic acid (Inofolic® Lo.Li. pharma s.r.l., Roma) for three months.; B 13 OAT patients treated with 4000mg/die of myo-inositol associated to 400 µg of folic acid (Inofolic® Lo.Li. pharma s.r.l., Roma) for three months; Group C 20 normospermic patients treated with 400 µg of folic acid (kindly provided by Lo.Li. pharma s.r.l., Roma) for three months.
Intervention MeSH terms: Folic Acid; Inositol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Myo-inositol; oligoasthenoteratospermia; semen parameters; IVF
Artificial Shrinkage of Fresh Blastocysts
Condition: Infertility Assisted Reproductive Technology
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The aim of the study is to determine if collapsing an embryo (or making it fold compactly by
      taking away its fluid) before the transfer in the uterine cavity improves pregnancy rates in
      assisted reproductive technology (ART).

      Women coming to our ART center will be randomized in two groups : the collapsing group and a
      control group.

      Pregnancy rates will be compared in the two groups. A biomarker (cell free DNA) will also be
      determined in each group and correlated to pregnancy occurrence.
    

Detailed description: 
      This is a prospective randomized study designed to determine if artificial shrinkage (AS)
      before transfer of embryos impact clinical pregnancy rate in single blastocyst embryo
      transfer (SBET) cycle. Women elected for SBET will be randomized on transfer day in two
      arms:the AS group where blastocoelic cavity is artificially reduced by a laser pulse prior to
      transfer and a control group.

      Clinical pregnancy rates will be compared. Secondarily, rate of monozygotic twin pregnancy
      and cell free DNA concentration in culture medium will be evaluated in the two groups.
    

Intervention name(s): Artificial shrinkage
Intervention type(s): Procedure
Intervention description(s): Artificial shrinkage of blastocyst
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Single blastocyst embryo transfer; Artificial Shrinkage; Clinical pregnancy rate; Cell free
Quality of Life and Lung Function on Post Covid-19 Patient
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      Gaining a greater understanding of how the breathing exercise combined with aerobic and
      strengthening exercises will affects lung function and quality of life in post covid-19
      persons
    

Detailed description: 
      this will improve exercise prescription guidelines relevant to this post covid-19. Therefore,
      the purpose of this work was determining the effect of breathing exercise combined with
      aerobic and strengthening exercises in improve chest expansion, lung function and quality of
      life in post covid-19 persons.
    

Intervention name(s): breathing exercise, Aerobic exercises
Intervention type(s): Other
Intervention description(s): 6 min of quiet breathing (3 sets of 2 min each), 6 min of diaphragmatic breathing (3 sets of 2 min each), 6 min of diaphragmatic breathing plus pursed-lips breathing (3 sets of 2 min each).
Other intervention name(s): resistance exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment