bioihbjkbjnl/mcl2 huggingface dataset:
Does Biological Sex Influence the Cardiac Output Response to Sprint Interval Exercise Training in Humans?
Condition: Exercise
Study type: Interventional

Summary: 
      Sprint interval exercise training refers to brief repeated bouts of vigorous effort that are
      separated by short periods of recovery. Cardiac output refers to the amount of blood that is
      pumped out of the heart each minute. Research has shown that sprint interval exercise
      training can increase peak cardiac output - or the highest cardiac output that is achieved
      during strenuous exercise - but this response may be influenced by biological sex. The
      primary goal of this study is to determine whether the peak cardiac output response to 12
      weeks of sprint interval exercise training differs between males and females. Cardiac output
      will be estimated using a non-invasive technique that involves breathing in a mixture of
      standardized gases. This research will help to determine whether biological sex influences
      the response of the heart to brief vigorous cycle exercise training.
    

Detailed description: 
      The primary purpose of this study is to determine whether biological sex influences the peak
      cardiac output response to 12 weeks of sprint interval exercise training. Peak cardiac output
      will be determined non-invasively using an inert gas rebreathing technique. Each session of
      sprint interval exercise training will involve a 10-minute period of cycling on a stationary
      ergometer. The protocol will consist of a two-minute warm-up; three, 20-second 'all out'
      efforts that are separated by two minutes of recovery; and a three-minute cool down. Three
      sessions of training will be performed each week for a total of 12 weeks. Groups of male and
      female participants will be recruited and tested using best practice guidelines for sex-based
      comparisons of exercise responses. The study will advance knowledge regarding the potential
      for biological sex to influence the cardiovascular response to brief vigorous cycle exercise
      training.
    

Intervention name(s): Sprint interval exercise training
Intervention type(s): Other
Intervention description(s): A 10-minute sprint interval exercise training protocol that is performed three times per week for a total of 12 weeks.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Cardiac output
Hydrocodone/Acetaminophen for Acute Pain Following Bunionectomy
Condition: Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this study was to evaluate analgesic efficacy and safety of
      hydrocodone/acetaminophen extended release compared to placebo in moderate to severe pain
      following primary unilateral first metatarsal bunionectomy.
    

Detailed description: 
      The bunionectomy was performed under regional anesthesia and propofol sedation. Perioperative
      anesthesia was standardized for all participants. Upon completion of surgery, designated
      study personnel ensured continued eligibility per the selection criteria of the protocol.

      After an appropriate period of time following bunionectomy, participants who had a pain
      intensity score of ≥ 40 mm on a 100 mm visual analog scale (VAS) and moderate or severe pain
      intensity per the categorical pain intensity scale were eligible for randomization, in equal
      numbers, into 1 of 5 treatment arms. In order to maintain the single-blind nature of the
      study, all participants were dosed with study drug (active and/or placebo) every 6 hours.
    

Intervention name(s): Hydrocodone/Acetaminophen Extended Release; Acetaminophen; Morphine Extended Release; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): ABT-712; Tylenol; Kadian
Intervention MeSH terms: Acetaminophen; Acetaminophen, hydrocodone drug combination; Morphine; Hydrocodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Postoperative Pain
Montreal Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device
Condition: Heart Failure; Mitral Regurgitation
MeSH terms: Heart Failure; Mitral Valve Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      Reduction in mitral regurgitation due to safe placement of a PTMA device in the coronary
      sinus.
    


Intervention name(s): PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant
Intervention type(s): Device
Intervention description(s): Percutaneous access from right or left subclavian vein, diagnostic assessment, then placement of the PTMA implant in the coronary sinus, great cardiac vein.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Heart Failure; Mitral Regurgitation
A Phase II Trial of Varenicline for the Treatment of Cocaine Dependence
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a double-blind placebo-controlled clinical trial (n = 156) of varenicline for the
      treatment of cocaine dependence that utilizes contingency management to promote treatment
      attendance.
    

Detailed description: 
      Background: Varenicline is a medication approved for the treatment of Tobacco Use Disorder.
      It is a partial agonist at α2β4 nicotinic acetyl choline receptors and a full agonist at α7
      nicotinic acetyl choline receptors. By its effects on cholinergic activity at α7 and α2β4
      receptors, varenicline may reduce dopaminergic and glutamatergic activity in the midbrain,
      and reduce symptoms of Cocaine Use Disorder. A preliminary trial of varenicline in human
      cocaine users suggested that varenicline treatment was associated with reductions in cocaine
      use. The current trial was intended to confirm these promising preliminary results.

      Methods: This was a 12-week, double blind, placebo controlled parallel group clinical trial
      involving 156 DSM IV cocaine dependent subjects. Subjects received 2 mg of varenicline or
      identical placebo each day along with weekly individual cognitive behavioral relapse
      prevention psychotherapy. The primary outcome measure was cocaine use measured by by thrice
      weekly urine drug screens. Additional outcome measures included cocaine withdrawal symptoms
      measured by the Cocaine Selective Severity Assessment (CSSA) End of study cocaine abstinence
      was analyzed using a Chi-square test.
    

Intervention name(s): Varenicline; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Chantix
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cocaine dependence
The Effect of Adding Nalbuphine to Intrathecal Morphine on Analgesic Efficacy and Side Effects After Cesarean Section
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary endpoint of this study is to investigate the effect of adding nalbuphine to
      intrathecal morphine on quality of postoperative analgesia and Morphine related side effects
      post- cesarean delivery.
    

Detailed description: 
      The study will be performed in Assiut University Hospitals, after obtaining approval from the
      local ethics committee and written informed patient consent. All patients will have a
      peripheral IV cannula 18 G inserted; standard non-invasive monitors will be applied. All the
      patients will be preloaded with 10 ml/kg Ringer's lactate solution intravenous. Intrathecal
      block under strict aseptic conditions will be performed in sitting position at L3-4 or L4-5
      inter-spinous space with 25G pencil-point spinal needle. All patients will receive
      intrathecal 10 mg of 0.5% hyperbaric bupivacaine.
    

Intervention name(s): Morphine; Morphine plus Nalbuphine
Intervention type(s): Drug; Drug
Intervention description(s): 38 patients of this group will receive 10 mg of 0.5% hyperbaric bupivacaine (Buvanest Spinal 0.5% Heavy) with 0.2 mg morphine (Infumorph - Injection 10 mg/mL) in 0.5 ml volume (total volume 2.5 mL). Patients will be preloaded with 10 ml/kg Ringer's lactate solution intravenous.; 39 patients of this group will receive 10 mg of 0.5% hyperbaric bupivacaine (Buvanest Spinal 0.5% Heavy) with 0.5 mg morphine (Infumorph - Injection 10 mg/mL) plus 0.2 mg nalbuphine (NALUFIN 20MG/ML AMP) in 0.5 ml volume (total volume 2.5 mL). Patients will be preloaded with 10 ml/kg Ringer's lactate solution intravenous.
Other intervention name(s): Infumorph; Infumorph and NALUFIN
Intervention MeSH terms: Morphine; Nalbuphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Prevention
The Effect of Age on the Median Effective Dose (ED50) of Intranasal Dexmedetomidine for Rescue Sedation Following Failed Sedation With Oral Chloral Hydrate During Magnetic Resonance Imaging
Condition: Aged; Drug; Dose-Response Relationship
Study type: Interventional
Phase: Phase 4

Summary: 
      Increasing evidences suggest that dexmedetomidine Pharmacokinetic are different in children.
      We performed a up-down sequential allocation study to determine the ED50 for rescue sedation
      following sedation failures in children and to investigate age-related differences in the
      rescue sedation with dexmedetomidine.
    

Detailed description: 
      About 150 children who were not adequately sedated ( no evidence of adequate sedation within
      30 min after administration of Initial dose of chloral hydrate) were stratified into four age
      groups as follows: 1-6 month, 7 -12 month, 13 -24 month, and 25-36 month. The intranasal
      dexmedetomidine dose was determined by the success or failure of rescue sedation achieved by
      the previous patients, according to Dixon's up-down sequential allocation method. Successful
      sedation was defined as a MOAA/S(modified Observer Assessment of Alertness and Sedation) of
      between 0 and 3. The EC50 were estimated from the up-and-down sequences using the method of
      Dixon and Massey and logistic regression. Patients' sedation status, sedation induction time,
      time to Wake up, blood pressure, heart rate, and oxygen saturation were recorded.
    

Intervention name(s): intranasal dexmedetomidine
Intervention type(s): Drug
Intervention description(s): Children who were not adequately sedated ( no evidence of adequate sedation within 30 min after administration of Initial dose of chloral hydrate) received a bolus of intranasal dexmedetomidine which adjusted by the "Dixon up-and-down method for rescue sedation.
The first child received 0.8mcg/Kg of intranasal dexmedetomidine dose (100mcg/ml), and the dose interval was set at 0.1mcg/Kg.
Intervention MeSH terms: Dexmedetomidine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Barriers to Eye Screening for People With Diabetes in India
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema
Study type: Interventional

Summary: 
      Brief Summary: Diabetic retinopathy (DR) is a leading cause of visual impairment and has
      major public health implications globally and especially in countries such as India where the
      prevalence of diabetes is high. With timely screening and intervention, the disease
      progression to blindness can be prevented but several barriers exist to the provision of
      care. The long term aim is to identify the barriers to DR screening and to plan potential
      interventional strategies. From the qualitative study, the reasons such as lack of awareness
      or knowledge, distance to travel, lack of reminder system were identified as a reason for
      poor follow-up. This lead to the development of interventional strategies.

      This was a randomized, investigator-masked clinical trial that was conducted in a tertiary
      eye care centre in South India. Consecutive patients with diabetes who were residents in
      Chennai and its vicinity of approximately 100 km radius and who were undergoing repeated
      intravitreal injections for DME were recruited into the trial. The aim of the study is to
      investigate the effect of SMS informational reminders among patients with Diabetic macular
      edema for the follow-up. They study consists of 2 groups, SMS reminder group receives the
      reminders 1 week and 2 days prior to the scheduled appointments with the concerned doctor on
      a particular date and time, whereas other group does not receive any reminders for the
      appointment schedule. After the follow-up, the patients will be screened for the attendance
      at the review visit.
    


Intervention name(s): SMS reminder; No SMS reminder
Intervention type(s): Other; Other
Intervention description(s): The group receives reminder for the follow-up at 1 week and 2 days prior to their scheduled appointments.; The group did not receives any SMS regarding scheduled appoinments.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Screening
Keywords: screening; follow-up; short message service
Physical Exercise Program for Family Caregivers of Dependent Patients
Condition: Caregiver; Physical Activity
Study type: Interventional

Summary: 
      This estudy evaluates the effects of physical exercise program on health related quality of
      life (HRQoL), pain and physical fitness in family caregiver.
    

Detailed description: 
      Justification: Research indicates that the dependent patient caregiver´s have physical,
      psychological and social repercussions, as consequence of the care that they provide. From
      Primary Health Care there is a "caregiver care program" to prevent and palliate this
      situation, consisting mainly in education programs in care and psychotherapy. There is
      controversy about the effectiveness of these programs, being necessary to develop new
      therapeutic strategies.

      Objectives: to determine the effects of a physical exercise program, adressed by the primary
      health care physioterapist, on health related quality of life (HRQol), pain and physical
      fitness in dependent patient caregivers included in the " caregiver care program" of a basic
      health area.

      Methodology: randomized clinical trial, with control group (GC = 32) and intervention group
      (GI = 36), double blind and pre and post-intervention evaluation. The GC received the usual
      program of the " caregiver care program". The GI also carried out a multi-component exercise
      program for 12 weeks, with 3 weekly sessions realized in group and monitored by
      physiotherapists. The outcomes variables are measured by Quality of life (SF-36), Burden
      (Zarit), anxiety (Goldberg Ansiety Questionanaire), depression (Yesavage Questionnaire), pain
      intensity (EVA), disability (Roland Morris) and physical fitness (battery of fitness tests).
      Patients evaluator and Outcomes Assessor are masked.

      Applicability of results: If the physical exercise program, carried out from the primary
      health care physiotherapy, improves the HRQol, pain and physical fitness, this intervention
      could be an effective therapeutic strategy in the "caregiver care programs". Furthermore the
      proposed intervention is simple, reproducible and requires few resources.
    

Intervention name(s): PE; Usual Care
Intervention type(s): Other; Other
Intervention description(s): Physical exercise program for familiy caregivers. 36 session physical exercise (3 sessions/week) performed by physioterapist. It incluided exercices to improve coordination, aerobic capacity, control motor and strenght; Usual Programe in primary care for family caregivers. 4 session (2 session/week). It incluides: ergonomy, postural hygiene, mobilitation of patients and self-care.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Pharmacokinetics of Sufentanil Sublingual Microtablet 30 mcg and 15 mcg in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to establish the single and multiple-dose pharmacokinetics (PK)
      of sublingual administration of the Sufentanil Sublingual Microtablet (SSM) 30 mcg and
      compare the pharmacokinetics of a single dose of SSM 30 mcg to 2 doses of SSM 15 mcg
      administered 20 minutes apart.
    


Intervention name(s): Treatment Arm A: Sufenta®; Treatment B: Sufentanil SSM 30 mcg; Treatment C: SSM 15 mcg; Treatment D: SSM 30 mcg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Sufenta® intravenous (IV) (50 mcg/mL) 30 mcg infused over 1 minute; single-dose SSM 30 mcg; 2 consecutive doses of SSM 15 mcg administered 20 minutes apart; 12 consecutive doses of SSM 30 mcg administered 1 hour apart
Intervention MeSH terms: Sufentanil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Plasma concentrations
Safety and Tolerability Study of LBS-008 in Healthy Adult Subjects After Single and Multiple Doses
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, randomized, double-blind, placebo-controlled, Single Ascending Dose
      (SAD) and Multiple Ascending Dose (MAD) study is planned to assess safety, pharmacokinetics
      (PK), and pharmacodynamics of LBS-008 in healthy adult volunteers.
    


Intervention name(s): LBS-008; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): LBS-008 oral capsules; Oral capsules
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
A Phase 1, Open-Label Evaluation of the Pharmacokinetics and Safety of a Single Dose of Apraglutide in Subjects With Normal and Impaired Hepatic Function
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is to assess the PK of apraglutide in subjects with hepatic impairment
      compared with matched control subjects with normal hepatic function following single SC dose
      administration.
    

Detailed description: 
      A two stage design, open label, multi-center, non-randomized trial to evaluate the the safety
      and tolerability of a single subcutaneous dose of 5 mg apraglutide in subjects with varying
      degrees of hepatic function. The hepatic function will estimated with the Child-Pugh
      classification.

      Part 1: 8 subjects with moderate hepatic impairment (Cohort 1) and 8 subjects with normal
      hepatic function (Cohort 2).

      Part 2: 8 subjects with mild hepatic impairment (Cohort 3) and 8 subjects with normal hepatic
      function (from Cohort 2 where possible and additional subject). Part 2 will be conducted only
      if the geometric mean ratio (GMR) of AUCinf or AUClast for the moderate hepatic impairment
      group compared to the control group is ≥2.
    

Intervention name(s): Apraglutide
Intervention type(s): Drug
Intervention description(s): Single dose of apraglutide 5mg.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatic Impairment; Liver Function; Hepatic Function
Evaluation of Ocular Surface in Hemodialysis Patients by Ocular Surface Analyzer
Condition: Hemodialysis; Ocular Surface Disease; Dry Eye; OSDI
MeSH terms: Dry Eye Syndromes
Study type: Observational

Summary: 
      We clinically observed that some hemodialysis patients had corneal epithelial dryness,
      shedding, edema, and persistent epithelial nonunion after ocular surgery, which seriously
      affected the effect of surgery, and it is necessary to study the ocular surface
      characteristics of hemodialysis patients. In this study, we examined the ocular surface and
      analyzed and investigated the characteristics of the ocular surface in hemodialysis patients
      to provide a basis for ocular surface intervention or treatment in hemodialysis patients
      before ocular surgery in clinical practice.
    

Detailed description: 
      This study is a clinical case-control study. A total of 36 hemodialysis patients and 36
      normal subjects were randomly selected from the Nephrology Department of the First Affiliated
      Hospital of Jinan University .All the subjects in the hemodialysis group (n = 36, 72 eyes)
      and the normal group (n = 36, 72 eyes) were investigated with the OSDI scale, and then
      bilateral ocular surface examinations were performed with Keratograph5M eye surface
      comprehensive analyzer. Non-invasive tear meniscus height (NITMH), first tear film break-up
      time (FTBUT), average tear film break-up time (ATBUT), dry eye severity grade, tear film
      lipid layer analysis (distribution and color), tear film lipid layer thickness grade,
      meibomian gland opening blocking site, meibomian gland opening blocking analysis, meibomian
      gland opening secretion oil character score, eye redness index analysis (conjunctiva, ciliary
      shape), and meibomian gland absence area score were recorded.
    

Intervention name(s): ocular surface analyzer
Intervention type(s): Device
Intervention description(s): Using ocular surface analyzer for Inspection
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        A total of 36 hemodialysis patients and 36 normal subjects were randomly selected from the
        Nephrology Department of the First Affiliated Hospital of Jinan University .