bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Flumazenil on Recovery From General Anesthesia With Isoflurane
Condition: Adverse Effect of Other General Anesthetics
Study type: Interventional

Summary: 
      Background and objectives: The inhalational anesthetic isoflurane is widely used in general
      anesthetics. Its mechanism of action involves interaction with the receptor of gamma-amino
      butyric acid (GABA), which is also the binding site for benzodiazepines. Flumazenil,
      benzodiazepine antagonist, reverses the effects of these drugs in GABA receptors and could
      therefore also reverse the effect of isoflurane. In anesthesia practice, extubation and early
      anesthetic recovery reduce morbidity and incidence of complications. The objective of this
      trial is to determine whether the use of flumazenil may contribute to faster recovery from
      anesthesia. Methods: 40 patients scheduled to undergo general anesthesia with isoflurane were
      enrolled in this prospective, double-blind, randomized trial. Patients were randomized to
      receive, at the end of anesthesia, flumazenil or placebo as allocated into two groups. The
      anesthetic technique was standardized. The groups were compared concerning values of Cerebral
      State Index (CSI), heart rate, blood pressure and oxygen saturation from the application of
      flumazenil or placebo until 30 minutes after injection. Data regarding time to extubation,
      time to reach ten points in the Aldrete-Kroulic score (AK = 10) and Vigilance score (VS = 10)
      was also collected. ANOVA test was applied to analyze the results, considering p <0.05.
    


Intervention name(s): Flumazenil; saline
Intervention type(s): Drug; Drug
Intervention MeSH terms: Flumazenil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
MK-7625A Versus Meropenem in Pediatric Participants With Complicated Urinary Tract Infection (cUTI) (MK-7625A-034)
Condition: Complicated Urinary Tract Infection; Pyelonephritis
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Pyelonephritis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aims to evaluate the safety and tolerability of MK-7625A (ceftolozane/tazobactam)
      compared with that of meropenem in pediatric participants with cUTI, including
      pyelonephritis.
    


Intervention name(s): Ceftolozane/Tazobactam; Meropenem
Intervention type(s): Drug; Drug
Intervention description(s): 12 to <18 years of age: Ceftolozane 1 g/dose; Tazobactam 0.5 g/dose via a 60-minute (±10 minutes) IV infusion every 8 hours for 7-14 days. <12 years of age: Ceftolozane 20 mg/kg with Tazobactam 10 mg/kg (not to exceed Ceftolozane 1 g and Tazobactam 0.5 g) via a 60-minute (±10 minutes) IV infusion every 8 hours for 7-14 days.; Meropenem 20 mg/kg (maximum 1 g/dose) administered IV every 8 hours for between 7 to 14 days.
Other intervention name(s): MERREM®
Intervention MeSH terms: Meropenem; Tazobactam; Ceftolozane; Ceftolozane, tazobactam drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
To Evaluate the Efficacy and Safety of Vitamin B12 Contains Extract of Lamb's Stomach in Treatment of Chronic Atrophic Gastritis (CAG)
Condition: Chronic Atrophic Gastritis (CAG)
MeSH terms: Gastritis; Gastritis, Atrophic; Atrophy
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether Gastropyloric Complex Capsules are safe and
      effective in the treatment of chronic atrophic gastritis (CAG).
    

Detailed description: 
      Till now, there is no ideal treatment to chronic atrophic gastritis(CAG). This study is try
      to find a possible treatment to CAG with Gastropyloric Complex Capsules.
    

Intervention name(s): Gastropylor Complex Capsules; Placebo Comparator
Intervention type(s): Drug; Other
Intervention description(s): 3 pills, three times a day, after meal; Placebo that is same as gastropyloric complex capsules
Other intervention name(s): Gastropyloric Extracts and Vit B12 Complex Capsules; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pain-related Evoked Potentials in Unilateral Peripheral Nerve Injuries
Condition: Peripheral Nerve Injuries
MeSH terms: Peripheral Nerve Injuries
Study type: Observational

Summary: 
      The study examines pain-related evoked potentials (PREP) in patients with peripheral nerve
      injuries. Since previous studies found altered latencies and amplitudes of PREP in
      generalized polyneuropathies, e. g. HIV-polyneuropathy and fibromyalgia, this study
      investigates if these alterations are detectable in unilateral peripheral nerve injuries as
      well.
    


Intervention name(s): Pain-related evoked potentials (PREP); Quantitative Sensory Testing (QST); Nerve conduction studies (NCS)
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): PREP were performed bilaterally with a concentric surface electrode at twice the individual pain threshold.; QST was performed bilaterally following the protocol of the German Network on Neuropathic Pain.; NCS were performed with patients only.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with PNI treated in the university hospital Bergmannsheil Bochum, Bochum, Germany.
Amiloride for Resistant Hypertension
Condition: Hypertension; Type 2 Diabetes Mellitus; Microalbuminuria
MeSH terms: Hypertension; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the antihypertensive effect of amiloride added to triple antihypertensive therapy
      in patients with resistant hypertension (RH) and type 2 diabetes mellitus (T2DM)
    

Detailed description: 
      The primary objective of this study was to evaluate the antihypertensive effect of amiloride
      added to triple antihypertensive treatment in patients with resistant hypertension and type 2
      diabetes mellitus in an open-labelled, non- controlled and non-randomized interventional
      study.

      The secondary objectives were to evaluate the additional effects of amiloride on:

        -  Urinary albumin excretion

        -  Blood pressure control, how many patients reached blood pressure control when amiloride
           was added to previous triple antihypertensive treatment.

        -  Plasminogen and plasmin excretion (ENaC activity) in the micro-and macroalbuminuric
           patients in the cohort.

        -  Urokinase plasminogen activator (uPA) activity
    

Intervention name(s): Amiloride
Intervention type(s): Drug
Intervention description(s): 5 mg(daily of amiloride was added to patients triple antihypertensive therapy and increased to 10 mg/daily if office blood pressure at 4 weeks was above 130/80 mmHg.
Intervention MeSH terms: Amiloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: antihypertensive therapy; amiloride; add-on; resistant hypertension; blood pressure control; type 2 diabetes mellitus,; microalbuminuria.
Evaluate the Effectiveness and Safety of the Alpinia Galanga Formulation, Theacrine Formulation, and Caffeine Formulation on Fatigue, Mental Acuity, and Cognitive Health
Condition: Fatigue
MeSH terms: Fatigue; Mental Fatigue
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effectiveness and safety of the Alpinia galanga
      formulation, Theacrine formulation, and Caffeine formulation on fatigue, mental acuity, and
      cognitive health among overall healthy participants
    

Detailed description: 
      This is a 4-arm pilot, double-blind, randomized, placebo-controlled, parallel design study. A
      total of 80 subjects (20 per treatment arm) will be enrolled in a randomly assigned sequence
      to receive either the Alpinia galanga formulation, Theacrine formulation, Caffeine
      formulation, or placebo in individuals and admit to experiencing occasional fatigue
      (tiredness) and would like more energy.

      Participants will need to complete assessments and questionnaires.

      The primary objective is the evaluation of the change in the response to the VAS-F (Visual
      Analogue Scale to Evaluate Fatigue Severity) relative to baseline. The secondary objective is
      the evaluation of the change in the responses to the BCAT-SF (Brief Cognitive Health
      Assessment Short Form), LSEQ (Leeds Sleep Evaluation Questionnaires), and SF-36 Health Survey
      (Short Form 36) compared to baseline.

      Safety and tolerability will be evaluated through the receipt of documentation and responses
      from the telephone contacts/ emails per protocol.
    

Intervention name(s): Alpinia galanga formulation; Theacrine formulation; Caffeine formulation; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Alpinia galanga formulation capsule- 1 capsule daily; Theacrine formulation capsule- 1 capsule daily; Caffeine formulation capsule- I capsule daily; Placebo capsule- 1 capsule daily
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Keywords: Energy; Fatigue; Tired; Sleep; Cognitive Health; Mental Acuity
Determinants of Formate Concentrations
Condition: Healthy
Study type: Observational

Summary: 
      Formate is an important metabolite, serving as a donor of one-carbon groups to the
      intracellular tetrahydrofolate pool. However, little is known of its circulating
      concentrations or of their determinants. This study seeks to define formate levels and their
      determinants in a young, healthy population.

      Serum formate will be measured in 1701 subjects from the Trinity Student Study. The subjects,
      males and females, aged 18 to 28 years, were enrolled at Trinity College, Dublin. Formate
      levels will be compared with other one-carbon metabolites, vitamin status, potential formate
      precursors, genetic polymorphisms, and lifestyle factors.
    


Intervention name(s): No Intervention
Intervention type(s): Other
Intervention description(s): Cross-sectional study requiring a single serum sample
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Serum formate was measured in 1701 subjects from the Trinity Student Study. The subjects,
        males and females, aged 18 to 28 years, were enrolled at Trinity College, Dublin
      
Keywords: formate; one-carbon metabolism
Inflammatory Markers in Pregnant Women Destined to Develop Preeclampsia
Condition: Preeclampsia
MeSH terms: Pre-Eclampsia
Study type: Observational

Summary: 
      The purpose of this study is to assess the predictive role of serum inflammatory markers in
      pregnant women who subsequently develop preeclampsia.
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Case-control study consisting of 43 women developping preeclampsia and 86 women not
        developping this disorder. All were of Caucasian origin and were nulliparous.
      
Biospecimen description: 
      serum
    
Keywords: prognostic marker
Antibacterial Effect and Clinical Performance of Chitosan Modified Glass Ionomer
Condition: Reversible Pulpitis; Pulpitis; Caries,Dental; Caries Class I; Caries; Dentin; Caries
MeSH terms: Pulpitis; Dental Caries
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is a randomized clinical trial that assesses the clinical success and the
      antibacterial effect on carious dentine of glass ionomer when modified with Chitosan and/or
      Titanium dioxide nano particles vs the control group of modification with Chlorhexidine as
      control when used in primary molars
    

Detailed description: 
      Participants will be recruited from the acquitted to the clinic of pediatric dentistry
      department , Faculty of Dentistry of Ain Shams University. random allocation of the
      participants where indirect pulp capping is indicated so that modified Glass ionomer would be
      used as the filling material.

      partial removal of caries is done then caries sample would be taken and sent for a
      microbiological evaluation and then, cavity dimensions is recoded, finally placement of the
      modified glass ionomer in the prepared cavity.

      In a total period of 9 months the patients will be followed every 3 months for clinical
      evaluation and in the final visit the filling would be removed and another bacterial sample
      would be taken for comparison, then a permanent filling is placed.
    

Intervention name(s): Glass Ionomer; Chitosan Low Molecular Weight (20-200 Mpa.S); Chlorhexidine Diacetate; Titanium Dioxide
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Glass ionomer filling material would be modified accordingly or used as is; deacetylated chitin, poly(D-glucosamine) purified by dissolving in 0.1 mol/L acetic acid, then precipitated in 0.1 mol/L sodium hydroxide and the precipitate will be washed with ethanol/water (70/30 v/v) mixture followed by freeze drying; Chlorhexidine antibacterial effect to be compared by Sigma-aldrich PHR 1222 , lot#LRAB3716; Titanium(IV) oxide,nanopowder, 21 nm primary particle size (TEM), >99.5% trace metals basis cat#718467 Lot#MKCB6332 Lot #MKCB6332
Other intervention name(s): Fuji IX; Aldrich, cat#448869, lot #STBG9041; chlorhexidine acetate; Titanium(IV) oxide
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate; Titanium dioxide; Chitosan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Glass ionomer; Chitosan; Titanium dioxide; Titanium dioxide nanoparticles; Chlorhexidine; indirect pulp capping; Alternative restorative technique; stepwise caries excavation; antibacterial restorative; incomplete caries removal; primary molars; early childhood caries
Effects of Creatine and Resistance Exercise Training in People With HIV Infection
Condition: HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This study was designed determine whether use of creatine monohydrate, a dietary supplement,
      can increase skeletal muscle mass and strength and improve the response to progressive
      resistance exercise training in people with HIV infection.
    

Detailed description: 
      This is a randomized, placebo-controlled study to evaluate the effect of creatine
      monohydrate, a dietary supplement, on skeletal muscle size and function (i.e., strength,
      energy metabolism, work capacity, fatigue); whole-body exercise performance; and body
      composition. This study is also designed to determine whether creatine supplementation
      augments the functional benefit derived from progressive resistance exercise. The safety of
      creatine supplementation in people with HIV infection will also be evaluated. Forty
      HIV-positive subjects will be randomly assigned, on a 1:1 basis, to receive creatine
      monohydrate or placebo for a period of 14 days, followed by a 12-week program of supervised
      progressive resistance exercise training during which administration of creatine monohydrate
      or placebo will continue.

      Measurements of muscle strength, size, composition, energetics and fatigue, as well as body
      weight and composition and serum biochemistries, will be made at baseline, after two weeks of
      treatment with creatine or placebo (before PRT), and again after 12 weeks of PRT (study week
      14). Safety will be monitored throughout the study.
    

Intervention name(s): Use of creatine monohydrate (a dietary supplement); Progressive resistance exercise training
Intervention type(s): Procedure; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Supportive Care
Keywords: Exercise; HIV; Creatine; Muscle
A Study to Evaluate Pharmacokinetics of Sonazoid™ Following Intravenous Bolus Injection in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to determine the Pharmacokinetics (PK) data of
      perfluorobutane (PFB) in blood and exhaled air following intravenous (I.V.) bolus injection
      of Sonazoid™ in healthy volunteers.
    


Intervention name(s): Sonazoid™
Intervention type(s): Drug
Intervention description(s): Single Dose of Sonazoid™ lipid-stabilised aqueous suspension of perfluorobutane (PFB) gas microbubbles.
Other intervention name(s): perfluorobutane
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
A Single Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of Orally Administered DAA-I in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a placebo-controlled randomized phase 1 study to investigate the safety and
      pharmacokinetics of DAA-I in a cohort of healthy subjects.
    

Detailed description: 
      The study will be a single-blind, step-wise dose escalation, placebo controlled study in
      healthy subjects consisting of up to 3 dose steps of DAA-I. In the sequential step wise
      design, a single dose of DAA-I or placebo will be administered to 6 subjects for one
      treatment group. For each dose step, 4 subjects will receive DAA-I and 2 subjects will
      receive placebo. Subjects will be randomly allocated to one dose step. Step One would have to
      be completed before Step Two. Escalation up to Step Two and subsequent steps would depend on
      the safety results from the preceding step(s). There will be an interval of 6 hours between
      the dosing of the first and second DAA-I-treated volunteers of each cohort to allow for early
      cardiovascular monitoring. Only if there are no safety signals identify from these subjects
      as assessed by the Safety Review Committee can simultaneous dosing of the remaining
      volunteers be carried out.
    

Intervention name(s): DAA-I; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Verbal Instruction for Contraction Pelvic Floor Muscles Among Males
Condition: Pelvic Floor Muscle Weakness
MeSH terms: Muscle Weakness
Study type: Interventional

Summary: 
      The aim of this study is to compare the effectiveness of different verbal instruction on
      pelvic floor muscle contraction among males. Pelvic floor contraction will be measured via
      ultrasound.
    

Detailed description: 
      This study will examine pelvic floor muscle contraction following six different verbal
      instructions among males. Physical-therapy students will be recruited to complete a survey
      and non-invasive transabdominal ultrasound assessment.

      A bladder filling protocol will be implemented to ensure subjects will have sufficient fluid
      in their bladders to allow clear ultrasound imaging. This protocol involved subjects
      consuming 600-750 ml of water in a 1 hr. period. The participants will be tested in a
      crook-lying supine position with a pillow under their heads for comfort.

      All participants will be given six different verbal instructions to contract pelvic floor
      muscles. Each contraction will be performed 3 time with rests of 10 sec between contractions.
      While the first 2 contractions for each verbal instruction will be held for 3 sec. the last
      contraction will be held as long as the participant can conduct and the time of contraction
      will be measured as well. The pelvic floor contraction will be measured by assessing bladder
      displacement via diagnostic ultrasound.

      To image the pelvic floor a 5 MHz curved linear array transducer (Mindray M5) will be placed
      in the transverse plane immediately suprapubically over the lower abdomen angled at 15-30
      degrees from the vertical. An on screen caliper and measurement tool will be used to measure
      bladder displacement.
    

Intervention name(s): verbal instruction
Intervention type(s): Other
Intervention description(s): Verbal instruction for pelvic floor contraction will be given to participants. Ultrasound examination will be conducted to asses urinary bladder displacement being a marker for pelvic floor muscle function.
Other intervention name(s): diagnostic ultrasound assesment
Intervention model: Single Group Assignment
Intervention model description: all participants will receive the same six verbal instruction given in a random order.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: verbal instruction, pelvic diaphragm, muscle contraction