bioihbjkbjnl/mcl2 huggingface dataset:
Artificial Oocyte Activation Comparing Tow Different Agents
Condition: Oocyte Fertilization
Study type: Interventional

Summary: 
      Comparing the efficacy of tow factors for artificial Oocyte Activation for poor quality
      Oocytes and Teratozoospermia patients.
    

Detailed description: 
      The IVF outcome had been varied widely with a good portion of total fertilization failure
      even after the most advanced procedure for this group of patient Intracytoplasmic Sperm
      Injection, many factors that had been tested for assisting the failed group of patient to be
      fertilized artificially like Ca Ionophore, Strontium Chloride and others but we decide to
      compare the clinically proven factors for the efficacy and safety in a well randomized
      clinical trial and monitor the embryogenesis and pregnancy within the 2 groups.
    

Intervention name(s): Artificial Oocyte activation; Ca Ionophore; Strontium Chloride
Intervention type(s): Other; Drug; Drug
Intervention MeSH terms: Ionophores
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effects of Memory Boot Camp on Brain Function in Adults With Symptoms of Mild Cognitive Impairment (MCI)
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      This is a prospective controlled clinical trial to determine the effects of a 12-week Memory
      Boot Camp (MBC) program on cognitive function in older adults with symptoms of Mild Cognitive
      Impairment.
    

Detailed description: 
      This prospective trial evaluates the 12-week, multi-domain Memory Boot Camp program for
      adults ages 55 to 85 with symptoms of mild cognitive impairment. The Memory Boot Camp program
      incorporates neurofeedback, heart rate variability biofeedback, memory and cognitive
      training, and one-on-one coaching to encourage behavior change in diet, sleep, physical
      fitness, and stress reduction. Participants are evaluated via neurocognitive assessments,
      questionnaires, quantitative electroencephalography parameters, and heart rate variability
      parameters at four time points: baseline, pre-program, post-program, and follow-up. The trial
      included a 12-week waiting period between baseline and pre-program, such that each
      participant acts as their own control, and follow-up takes place six months after completion
      of the program.
    

Intervention name(s): Multi-domain Intervention
Intervention type(s): Other
Intervention description(s): Intervention includes neurofeedback, heart rate variability biofeedback, memory and cognitive training, and one-on-one coaching to encourage behavior change in diet, sleep, physical fitness, and stress reduction.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Inspiratory Muscle Training on Diaphragm Thickness, Inspiratory Muscle Pressure and Physical Function
Condition: Healthy
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      Fatigue of the respiratory muscles is one of the limitations of exercise at high intensity,
      although the mechanisms that explain it are not yet clear. This fatigue would cause a
      decrease in physical performance and could limit the functional capacity of the subject. In
      this sense, it has been shown that specific training of respiratory muscles, especially
      inspiratory muscles, improves their strength and resistance both in healthy people and in
      people with pathologies; managing to improve the quality of life and both physical and sports
      performance. This study, which follows the quantitative method and proposes an analytical,
      experimental, longitudinal and prospective design (with the aim of conducting a randomized
      clinical trial), proposes an intervention based on performing a specific training of
      inspiratory muscles for 8 weeks, taking 30 maximum inspirations at 60% of the PIM (maximum
      inspiratory pressure), 2 times a day for 5 days a week; with the aim of assessing the effects
      on inspiratory function, cardiorespiratory fitness when performing a stress test (Harvard
      step test) and diaphragm thickness measured by ultrasound. 40 healthy subjects between 18 and
      25 years old will be recruited and divided into two groups: an experimental group (n = 20)
      and a control group (n = 20).
    


Intervention name(s): Inspiratory muscle strength training
Intervention type(s): Other
Intervention description(s): Inspiratory muscle training during 8 weeks, 30 inspirations at 60% of the PIM (maximum inspiratory pressure), 2 times a day for 5 days per week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Comparative Pharmacokinetic Study of Lidocaine Patch 1.8% (ZTlido™) and Lidocaine Patch 5% (Lidoderm®) in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize the comparative single-dose pharmacokinetics
      (bioequivalence) of lidocaine patch 1.8% (investigational product) versus Lidoderm®
      (lidocaine patch 5%,reference product).
    


Intervention name(s): Lidocaine topical system 1.8%; Lidocaine patch 5%
Intervention type(s): Drug; Drug
Other intervention name(s): Lidocaine patch 1.8%; ZTlido; Lidoderm
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Aerobic Training on the Autonomic Modulation in Children
Condition: Healthy
Study type: Interventional

Summary: 
      The heart rate variability is a tool used to asses non-invasive cardiac autonomic. In fact,
      many studies have been disseminated of heart rate variability in adults, however few results
      in a literature this parameters in pediatric population, mainly with children submitted the
      physical training. Thus, this Project aims to verify the effects of aerobic training, with 10
      weeks, in prepubertal on the performance and heart rate variability in rest.
    

Detailed description: 
      The randomized control trial in accordance with Consort - Statement (Moher et al., 2012) will
      be done. Will be included 160 children, 80 in an experimental group and 80 children with no
      intervention, of both genders.
    

Intervention name(s): Aerobic Training
Intervention type(s): Other
Intervention description(s): Will be included 160 children, 80 in an experimental group and 80 in a control group of both genders. The experimental group will realize aerobic training during 10 weeks (3×40min week-1; intensity, >80% maximal aerobic velocity - MAV), while the control group will have involved with the physical education classes two times a week for 50 minutes each class. The aerobic protocol will be composed by 2 sessions of intermittent running and 1 session by continuous.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: heart rate variability; children; progressive test
Interaction Study SLV337/Simvastatin
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the effect of multiple doses of SLV337 on the pharmacokinetics of simvastatin
      and simvastatin acid when co-administered in healthy male subjects
    


Intervention name(s): Simvastatin- SLV337 SD beta- SLV337 SD alpha - SLV337 MD beta- SLV337 SD beta+ Simvastatin; Simvastatin - SLV337 SD alpha - SLV337 SD beta - SLV337 MD beta - SLV337 SD beta+ Simvastatin
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of 40 mg simvastatin tablet, single dose of 1400 mg SLV337 beta capsule, single dose of 1400 mg SLV337 alpha capsule, multiple dose over 12 days of 1400 mg/day SLV337 beta capsule including a single dose of 40 mg simvastatin tablet before the last dosing day; Single dose of 40 mg simvastatin tablet, single dose of 1400 mg SLV337 alpha capsule, single dose of 1400 mg SLV337 beta capsule, multiple dose over 12 days of 1400 mg/day SLV337 beta capsule including a single dose of 40 mg simvastatin tablet before the last dosing day
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Interaction SLV337 and simvastatin; Type 2 diabetes mellitus
Clinical Intervention Study in the Primary Care Setting of Patients With High Plasma Fibrinogen (EFAP)
Condition: Cardiovascular Risk Factors
Study type: Interventional

Summary: 
      Objectives:

        -  To study the possible effects of an intensive lifestyle change program on, the plasma
           fibrinogen levels in patients with no cardiovascular disease, with a high fibrinogen and
           normal cholesterol levels, and moderate Cardiovascular Risk (CVR).

        -  To analyse whether or not the effect on fibrinogen is independent of the effect on
           lipids.

      Methods: Controlled, randomised clinical trial in 13 Basic Health Areas (BHA) in L'Hospitalet
      de Llobregat (Barcelona) and Barcelona city. Of the 436 patients between 35 and 75 years with
      no cardiovascular disease, with a high plasma fibrinogen (> 300 mg/dl) and a plasma
      cholesterol < 250 mg/dl, 218 received a more frequent and intensive intervention, consisting
      of advice on lifestyle changes and treatment. The follow up frequency of the intervention
      group was every two months. The other 218 patients continued with their usual care in the
      BHAs. Fibrinogen, plasma cholesterol and other clinical biochemistry parameters were
      assessed.
    


Intervention name(s): Lifestyle intensive group
Intervention type(s): Behavioral
Intervention description(s): hipocaloric diet smoking cessation physical exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Fibrinogen; Cholesterol; Cardiovascular risk factors; Primary prevention; High levels fibrinogen; High plasma fibrinogen
Effect of Pollen Extract on Urinary Incontinence
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Study type: Interventional
Phase: Phase 3

Summary: 
      Study with food supplement to assess the eficacy of pollen extract on Urinary Incontinence
    


Intervention name(s): Pollen extract
Intervention type(s): Dietary Supplement
Intervention description(s): 1 tablet a day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Effectiveness and Safety of Methadone Versus Placebo for the Control of Neuropathic Pain in Different Etiologies
Condition: Neuropathic Pain
MeSH terms: Neuralgia
Study type: Interventional
Phase: Phase 3

Summary: 
      Opioids are currently ranked as third-line agents for neuropathic pain (NP) treatment. The
      opioids more frequently tested for NP were tramadol, oxycodone and morphine. In the present
      study test the safety and effectiveness of methadone in patients with NP who remain
      symptomatic despite the use of first and second line drugs in a placebo-controlled randomized
      approach.
    

Detailed description: 
      Background: neuropathic pain (NP) is highly refractory and it is estimated that about 40% of
      patients remain symptomatic despite the use of first and second line drugs. Opioids are
      currently ranked as third-line agents for NP treatment. The opioids more frequently tested
      for NP were tramadol, oxycodone and morphine. In the present study test the effectiveness and
      safety of methadone, an opioid agonist and glutamate n-methyl-d-aspartate (NMDA) receptor
      antagonist in patients with NP who remain symptomatic despite the use of first and second
      line drugs in a placebo-controlled randomized approach.

      Patients and Methods: this is a randomized, placebo controlled superiority trial including 80
      subjects, aged between 18 and 85 years, with NP, that will be randomized to receive methadone
      or placebo in a 1:1 ratio. Enrollment will take place at the Pain Center of the University of
      São Paulo and it will include patients from primary care clinics from an area of 2 million
      people addressed to specialized care at a referral center.

      Expected results: the study hypothesis is that methadone is superior to placebo and it is
      safe to use that medication in patients with neuropathic pain.

      Recruitment time will be extended by 12 months due to dropouts related to the Covid pandemic.
      We have had dropouts due to a few patients developing covid and also due to patients having
      fear to become infected while attending hospital visits
    

Intervention name(s): methadone tablets; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The intervention with the active drug (methadone) will start with the dose of 1 tablet (5 mg) twice a day (every 12 hours) and titrated on subsequent visits up to the maximum dose of 6 tablets a day (totaling 30 mg divided into 2 daily doses to facilitate therapeutic adherence).; In this arm patients will take placebo tablets (the same number, color and physical aspects as the methadone tablets).
Other intervention name(s): Mytedom
Intervention MeSH terms: Methadone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Methadone; Neuropathic Pain; Opioid; Pain
A Study to Investigate Safe and Tolerable Dose of GMA301 Injection in Healthy Volunteers
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a single-centre, randomized, double-blind, placebo-controlled, dose escalation
      study to assess the safety, tolerability and PK of GMA301 Injection in healthy subjects. Two
      sequential dosing cohorts (at ascending dose fashion), each with 6 subjects receiving GMA301
      Injection and 2 subjects receiving placebo (total of 16 subjects), will be given single
      doses. The doses to be administered in the two cohorts will be 1500 mg and 2000 mg
      respectively, or matching placebo
    

Detailed description: 
      The current study is an extension of the previous study #1010218 (ACTRN12618000121268) to
      further explore the safety and PK profile of GMA301 injection at higher dosage. The SRC
      (Safety Review Committee) will be responsible for the assessment of safety, tolerability, and
      PK data for each dose level and to make decisions with regards to study progression. A
      Statistical Analysis Plan (SAP) will be written after finalizing the protocol and prior to
      database lock. The SAP will detail the implementation of all the planned statistical analyses
      in accordance with the principal features stated in the protocol. Adverse events will be
      coded using the Medical Dictionary for Regulatory Activities (MedDRA).
    

Intervention name(s): GMA301 Injection; GMA301 Placebo Injection; GMA301 Injection
Intervention type(s): Drug; Other; Drug
Intervention description(s): GMA301 Injection administered as a single dose of 1500 mg; GMA301 Injection without GMA301 administered as a single intravenous dose; GMA301 Injection administered as a single dose of 2000 mg
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Two sequential dosing cohorts, each with 6 subjects receiving GMA301 Injection and 2 subjects receiving placebo (total of 16 subjects). The doses to be administered will be 1500 mg and 2000 mg, or matching placebo, single dosing. Each cohort will include at least 2 participants of Chinese descent, if possible.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Lactobacillus Probiotic on Healthy Adults
Condition: Antibiotic-associated Diarrhea
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 1

Summary: 
      Diarrhea is a common side effect of antibiotics; it may prolong hospital stay, increase the
      risk of other infections, develop into more serious forms of disease, and lead to premature
      discontinuation of the needed antibiotic. The purpose of this study is to examine the safety
      and effectiveness of a capsule containing Lactobacillus rhamnosus GG in the prevention of
      diarrhea associated with antibiotic use.
    


Intervention name(s): Culturelle
Intervention type(s): Biological
Intervention description(s): 10^10 Lactobacillus rhamnosus GG per capsule
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effects of Training on Central Auditory Function in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The purpose of this study is to characterize the central auditory processing (CAP) deficits
      that result from multiple sclerosis (MS).
    

Detailed description: 
      Five general types of evaluations will be employed over multiple study sessions at the
      National Center for Rehabilitative Auditory Research (NCRAR). First, a neurologist will
      review the subject's medical history and perform a neurologic exam to confirm MS diagnosis.
      Second, peripheral auditory function will be evaluated using a standard set of routine
      audiometric tests. Additionally, subjects will complete a case history and series of hearing
      handicap inventories. Third, a battery of behavioral procedures will be used to characterize
      central auditory processing. Fourth, auditory evoked potential studies will be performed.
      Emphasis here will be upon evoked potentials whose putative neural generators lie within the
      central auditory nervous system. Fifth, subjects will receive magnetic resonance imaging
      (MRI) evaluation to determine sites and amount of neural degeneration.
    

Intervention name(s): Auditory training; MS: Control Activity
Intervention type(s): Behavioral; Other
Intervention description(s): the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued.; MS group not receiving auditory training, doing control activity
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: MS; CAP
Online Resources to Manage Obesity and Health Risks in an Employee Wellness Program
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether different types of online health tools can
      aid overweight individuals in reducing their weight and managing their cardiovascular risk
      factors in the context of an employee wellness program.
    


Intervention name(s): Goal-Setting Tool; Health Web Sites
Intervention type(s): Other; Other
Intervention description(s): Access to an online health-related goal-setting tool through the MyHealthAtVanderbilt patient portal; Access to publicly available health-related web sites
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Obesity
The Cerebral Hemodynamic and Cognitive Effects of Acute Resveratrol Administration in Young, Healthy Adults at Stimulated Altitude.
Condition: Hypoxia, Altitude; Brain
MeSH terms: Altitude Sickness; Hypoxia
Study type: Interventional

Summary: 
      Background: Vaso-active polyphenols have been proposed to enhance cognitive performance. Oral
      administration with the non-flavonoid polyphenol, resveratrol, has been found to modulate
      cerebral blood flow (CBF); yet, this has not resulted in subsequent predicted benefits to
      cognitive performance in young, healthy samples. It has been argued that ageing populations
      who are noted suffer a reduction in CBF and cognition, may possess the subtle deficits to
      benefit from resveratrol administration. The use of hypoxia has been previously tested by
      this research group to mimic the decrease in cognitive functioning associated with ageing.

      Objectives: The current investigation aimed to further assess if a reduced fraction of
      inspired oxygen (12.7% FiO2) could provide an experimental model of aging in a young, healthy
      sample. Moreover, the current study also aimed to assess if resveratrol can attenuate the
      deficits elicited by the reduction in oxygen supply via increased CBF.

      Design: This repeated measures, double blind, placebo controlled, balanced design assessed
      the cognitive and CBF effects of resveratrol in hypoxia (equivalent to 4000 m above sea
      level) and normoxia (sea level).

      Methods: Twenty-four participants arrived fully fasted (except water) for 12 hours before
      completing a baseline measure of a cognitive task battery, and taking the treatment for the
      day (either 500 mg resveratrol or inert placebo). Following a 45 min absorption period,
      participants completed 3 full repetitions of a cognitive test battery. Changes in cerebral
      hemodynamics were measured by near-infrared spectroscopy throughout the full testing session.
    


Intervention name(s): Resveratrol; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention MeSH terms: Resveratrol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Resveratrol; Cerebral blood flow; Cognition; Hypoxia; Polyphenols