bioihbjkbjnl/mcl2 huggingface dataset:
Surgical Treatment of Adult Trigger Finger
Condition: Trigger Finger
MeSH terms: Trigger Finger Disorder
Study type: Observational

Summary: 
      Trigger finger is a condition commonly treated with surgical intervention, yet no specific
      incision type has been associated with improved or worsened scar quality or outcome.
      Therefore, the investigators objective is to determine if the incision type may affect the
      results of operative treatment of trigger finger. Therefore, the goals of this study are as
      follows:

      Primary Objective: To directly compare incision type (transverse vs. longitudinal) for
      trigger finger release with scar quality and patient satisfaction via a validated scar
      evaluation scale.

      Secondary Objective: To directly compare incision type (transverse vs. longitudinal) for
      trigger finger release to patient outcome via a validated upper extremity outcome score.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients over the age of 18 presenting to the four attending surgeons with Trigger
        Finger
      
Keywords: Trigger Finger; Prospective Clinical Research; Randomized; Questionnaires; Transverse; Longitudinal
Prevention Post Operative Nausea Vomiting in Ambulatory Gynecologic Laparoscopy
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the incidence of Postoperative nausea and vomiting
      between the intervention group who received multimodal antiemetic management and the control
      group who did not get this protocol.
    


Intervention name(s): Dexamethasone; Ondansetron; Dimenhydrinate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 4 mg iv before induction for high and extremely high risk; 4 mg iv before ended surgery 30 min; 1 mg/kg iv before ended surgery 30 min
Other intervention name(s): Multimodal antiemetic group :; high risk : dexamethasone 4 mg + ondansetron 4 mg; Extremely high risk : dexamethasone 4 mg +; ondansetron 4 mg +; dimenhydrinate 1 mg
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Ondansetron; Antiemetics; Dimenhydrinate; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Postoperative Nausea and Vomiting; Ambulatory; Gynecologic laparoscopy; Incidence of postoperative nausea and vomiting.
Effects of Danggui Buxue Tang on Blood Biochemical Parameters in Male Recreational Runners
Condition: Sports Anemia; Inflammation; Oxidative Stress; Iron Deficiency; Hemolysis; Fatigue
MeSH terms: Iron Deficiencies; Inflammation; Hemolysis
Study type: Interventional

Summary: 
      The aim of this study is to examine the beneficial effects of Danggui Buxue Tang on blood
      biochemical parameters in male recreational runners.
    

Detailed description: 
      1. Male recreational runners would be recruited by community websites or email. After
           completely introducing the study, the participants would be requested to sign informed
           consent.

        2. The participants would perform maximal oxygen consumption test prior to the
           supplementation. The participants would be supplemented with either Danggui Buxue Tang
           or placebo for a week before performing the 13-km run. A total of 4 times blood
           collection (before supplementation, immediate after running, 1 day and 3 days after
           running) would be performed for evaluating the effect of Danggui Buxue Tang on blood
           biochemical parameters.
    

Intervention name(s): Danggui Buxue Tang; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Danggui Buxue Tang purchased from Kaiser Pharmaceutical; Consisting of corn starch and carboxymethyl cellulose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Adrecizumab-LPS Study
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      In this randomized, double-blind, placebo-controlled study, either a single dose of
      Adrecizumab (0.5, 2.0 or 8.0 mg/kg) or placebo will be administrated to 24 healthy male
      volunteers during experimental endotoxemia.
    

Detailed description: 
      Adrenomedullin (ADM) is a natural occurring 52 amino acid peptide which is mainly expressed
      in endothelial and smooth muscle cells. ADM plasma levels are increased in patients with
      sepsis and related with severity of disease. ADM is a key regulator of vasotonus and of
      endothelial integrity in sepsis. Adrecizumab is an antibody against the N-terminus of ADM
      which only partially inhibits the bioactivity of ADM. Several septic animal studies have
      shown that administration of Adrecizumab leads to stabilization of hemodynamics in mice and
      pigs, improved renal function, reduced catecholamine demand, improved fluid balance and
      improved survival. The administration of Adrecizumab to rodents, non-human primates and
      recently humans, has been tolerated very well.

      The experimental human endotoxemia model, in which healthy male volunteers receive a low dose
      of lipopolysaccharide (LPS) derived from Escherichia coli, is widely used to study the
      effects of systemic inflammation in humans in vivo and is considered a safe and highly
      reproducible method to activate the innate immune system. Furthermore, previous data has
      shown that experimental human endotoxemia results in increased plasma ADM levels. In this
      study, the investigators wish to assess the safety, tolerability and
      pharmacokinetics/-dynamics of Adrecizumab under inflammatory conditions in healthy
      volunteers.
    

Intervention name(s): Endotoxin; Placebo; Adrecizumab
Intervention type(s): Drug; Drug; Drug
Intervention description(s): At T=0 1 ng/kg E. Coli type O113 lipopolysaccharide is administrated intravenously as a bolus, followed by 1 ng/kg/hour for 3 hours.; At T=1 hour, placebo will be administered intravenously over a 1 hour period. Placebo is indistinguishable from Adrecizumab.; At T=1 hour, Adrecizumab will be administered intravenously over a 1 hour period.
Other intervention name(s): LPS; Lipopolysaccharide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Adrecizumab; Adrenomedullin; Healthy volunteers; LPS; Monoclonal recombinant antibody
Phase 1 Study of Intranasal PIV5 COVID-19 Vaccine Expressing SARS-CoV-2 Spike Protein in Healthy Adults and Adolescents
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1 trial is an open-label trial to evaluate the safety, reactogenicity and
      immunogenicity of two dosages (10^6 PFU and 10^7 PFU) of intranasal CVXGA1 administered as a
      single dose in healthy adults age 18-55 years and in adolescents age 12-17.
    

Detailed description: 
      This is an open-label, dose-ranging phase 1 trial of the PIV5 virus-vectored SARS CoV-2 S
      glycoprotein vaccine (CVXGA1) in healthy adults (males and nonpregnant females) 18 to 55
      years of age that have not had a prior COVID vaccination (Groups 1 and 2), and in healthy
      adults 18 to 55 years of age (Groups 3) and adolescents 12-17 years of age (Group 4) who have
      received at least two doses of mRNA-based COVID vaccines (Pfizer Comirnaty® or Moderna
      Spikevax™) with the last dose at least 5 months prior to planned receipt of CVXGA1 study
      vaccine. The trial is designed to assess the safety, reactogenicity, and immunogenicity of a
      single dose of intranasal CVXGA1. Two dose levels will be assessed, CVXGA1-low lose (LD) at
      106 plaque-forming units (PFU) (Group 1) and CVXGA1-high dose (HD) at 107 PFU (Groups 2, 3
      and 4).
    

Intervention name(s): CVXGA1 low dose; CVXGA1 high dose
Intervention type(s): Biological; Biological
Intervention description(s): see arm/group description; see arm/group description
Other intervention name(s): PIV5-SARS CoV-2 vaccine; PIV5-SARS CoV-2 vaccine
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Progression will be by dose escalation (low dose to high dose) in healthy adults aged 18 to 55 years (N=up to 60), with approximately 12 months' follow-up. Safety data from sentinel subjects (4) will be assessed by a safety monitoring committee (SMC) if halting rules are met for 1) vaccine administration to the remaining subjects within the group, 2) progression from the low dose (1 x 106 PFU) group to the high dose (1 x 107 PFU) groups (without or with prior receipt of COVID vaccine), and 3) progression from the high dose adult group (18 to 55 years) with prior receipt of COVID vaccine to the adolescent (12-17 years) group (N= up to 20) with prior receipt of COVID-19 vaccine.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Intranasal Vaccine; COVID-19
Tolerability and Pharmacokinetics of Metformin and Metformin Extended Release (ER)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the gastric tolerability and the pharmacokinetics
      of an extended release metformin compared with an immediate release metformin in healthy
      subjects.
    


Intervention name(s): metformin ER; metformin
Intervention type(s): Drug; Drug
Intervention description(s): 850mg daily for 30 days; 850 mg daily for 30 days
Other intervention name(s): predial plus; extended release predial plus
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Metformin ER; Pharmacokinetics; Tolerability; Healthy volunteers
Inhaled Corticosteroid Treatment of COVID19 Patients With Pneumonia
Condition: Coronavirus Infection
MeSH terms: Pneumonia; Coronavirus Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      Randomized, prospective, controlled open label clinical trial aimed at investigating if the
      addition of inhaled corticosteroids (budesonide) reduces treatment failure (defined as a
      composite variable by the initiation of treatment with high flow-O2 therapy, non-invasive or
      invasive ventilation, systemic steroids, use of biologics (anti IL-6 or anti IL-1) and/or
      death) according to hospital standard of care guidance) at day 15 after initiation of
      therapeutic intervention.
    


Intervention name(s): Inhaled budesonide
Intervention type(s): Drug
Intervention description(s): adding budesonide to standard of care for pneumonia in COVID19 positive patients
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate Inhibition of Ovulation of Two Oral Estrogen/Progestogen Regimens in Healthy, Young Females Over a Period of 3 Treatment Cycles
Condition: Contraception
Study type: Interventional
Phase: Phase 2

Summary: 
      Investigation of a new pill containing an estrogen and a progestin in order to monitor the
      inhibition of the ovulation in young healthy females over 3 treatment cycles
    


Intervention name(s): BAY86-4891 (Estradiol / Drospirenone); BAY86-4891 (Estradiol / Drospirenone)
Intervention type(s): Drug; Drug
Intervention description(s): Monophasic regimen containing estrogen and progestin 1 pre-treatment cycle, 3 treatment cycles; Triphasic regimen containing estrogen and progestin 1 pre-treatment cycle, 3 treatment cycles
Intervention MeSH terms: Drospirenone; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Contraception
Ocular Surface Metabolo-lipidomics in Lateral Amyotrophic Sclerosis
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      Amyotrophic Lateral Sclerosis (ALS) is the most common neurodegenerative disease affecting
      the motor neuron. Currently, there is no diagnostic test and no examination that can predict
      the evolution of this pathology. The search for diagnostic and prognostic biomarkers is
      therefore essential for a better understanding of the pathophysiology of ALS, which remains
      poorly understood, and also for better clinical management. The ocular surface, made up of
      liquid elements, tears, and cells, is an accessible anatomical-physiological entity that has
      demonstrated its usefulness in the identification of biomarkers in neurodegenerative diseases
      such as Parkinson's or Alzheimer's. To date, no study has explored the ocular surface as a
      biomarker in ALS
    


Intervention name(s): Measure of visual acuity; Interferometry; Samples of basal tears; Central corneal sensitivity; Slit lamp examination and undilated fundus; Conjunctival impression; Evaluation of the corneal innervation
Intervention type(s): Other; Other; Other; Other; Other; Other; Other
Intervention description(s): ETDRS and Parinaud scale; Non-contact exam measuring N.I.B.U.T (Non-invasive break-up time), quantitative and qualitative evaluation of the meibomian glands and quantitative evaluation of the tear meniscus; Collection of basal tears without instillation of anesthetic with a Schirmer strip for 5 minutes and by microcapillary; Central corneal sensitivity using a Cochet-Bonnet esthesiometer (Luneau©); Slit lamp examination and undilated fundus; Conjunctival impression with anesthetic instillation; Contact corneal confocal microscopy
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Amyotrophic Lateral Sclerosis; Biomarkers; Ocular Surface; Tear
Behavioral Intervention in Reducing Indoor Tanning
Condition: Healthy Subject
Study type: Interventional

Summary: 
      This randomized clinical trial tests the efficacy of a behavioral intervention works in
      reducing indoor tanning. Artificial ultraviolet indoor tanning increases the chance of
      developing skin cancers. Behavioral interventions use techniques to help participants change
      the way they react to environmental triggers that may cause a negative reaction.
    

Detailed description: 
      PRIMARY OBJECTIVE:

      To develop and evaluate an online tailored indoor tanning (IT) intervention based on findings
      from phase 1.

      OUTLINE:

      INTERVENTION: Participants are randomized to 1 of 2 groups.

      GROUP I: Participants receive intervention, weekly text messages about IT reduction, and
      personalized booster intervention. Participants then receive text messages twice weekly for 4
      weeks.

      GROUP II: Participants are placed on wait-list and may receive full intervention after
      follow-up.

      After completion of study, patients are followed up at 3 months.
    

Intervention name(s): Questionnaire Administration; Internet-Based Intervention
Intervention type(s): Other; Other
Intervention description(s): Questionnaire; Intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Neuropeptide Y and Sympathovagal Balance
Condition: Physical Activity; Sympathetic Nervous System; Secretion; Catecholamine
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Neuropeptide Y (NPY) activates the sympathetic and vagal nervous systems through the Y1 and
      Y2 receptors. This double-blind placebo-controlled crossover study investigated the
      sympathovagal balance during three exercises on a cycloergometer in healthy volunteers
      treated with saxagliptin (DPP4 inhibitor).
    

Detailed description: 
      Pharmacological studies indicate that NPY has a role as a co-transmitter associated with
      catecholamines to maintain cardiovascular homeostasis. The development of a selective and
      sensitive assay of NPY1-36 (vasoconstrictor) and NPY3-36 (vasodilator) by LC-MS/MS will
      confirm this modulating role of NPY in sympatho vagal balance in healthy young subjects. This
      project should lead to a better understanding of the contribution of NPY to exercise
      physiology through a double-blind randomized study using a DPP4 inhibitor (Saxagliptin) used
      for the treatment of type 2 diabetes, blocking the formation of NPY3-36 and thus enhancing
      the effect of NPY1-36. The interest of this study will be to find targets other than
      adrenergic receptors in the regulation of sympathetic and parasympathetic systems during
      exercise.
    

Intervention name(s): Saxagliptin 5mg; Placebo oral capsule; ergometric test in healthy volunteers
Intervention type(s): Drug; Drug; Other
Intervention description(s): Randomised study: session 1 the volunteer will receive either saxagliptin or placebo. Session 2 the volunteer will receive the placebo or saxagliptin; Randomised study: session 1 the volunteer will receive either saxagliptin or placebo. Session 2 the volunteer will receive the placebo or saxagliptin; The volunteers will undergo an ergometric test in each session
Intervention MeSH terms: Saxagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: double-blind placebo-controlled crossover study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: neuropeptide Y,catecholamine, exercise
A Study on the Effects of Valproate on the Pharmacokinetics of RO4917838 in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This open-label, fixed-sequence, two-period study will assess the effect of multiple dose
      valproate on the pharmacokinetics of RO4917838 at steady state and vice versa in healthy male
      volunteers. In Period 1, subjects will receive valproate for 5 days. After a washout period
      of 5 days to 2 weeks, subjects will receive, in Period 2, RO4917838 for 15 days with
      concomitant valproate on Days 11-15. Anticipated time on study is up to 12 weeks.
    


Intervention name(s): RO4917838; valproate
Intervention type(s): Drug; Drug
Intervention description(s): Multiple doses; Multiple doses
Intervention MeSH terms: Valproic Acid
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Evaluate Safety of ComBe Five (Liquid) in Healthy Vietnamese Children Aged From 8 - 10 Weeks as a 3-dose Series, Interval for Each Dose is 4 Weeks
Condition: Safety, Pentavalent Vaccine
Study type: Interventional

Summary: 
      An open label, non-comparative bridging study to evaluate the safety of pentavalent vaccine
      ComBe Five (Liquid) made in India, in healthy Vietnamese children aged from 8 - 10 weeks as a
      3-dose series, interval for each dose is 4 weeks
    

Detailed description: 
      The trial is a bridging Study to evaluate safety of pentavalent vaccine ComBe Five (Liquid)
      made in India, in healthy Vietnamese children aged from 8 - 10 weeks as a 3-dose series,
      interval for each dose is 4 weeks. 330 subjects will be enrolled in Binh Luc and Ly Nhan
      district, Ha Nam province. These subjects will be received 3 doses (0.5ml/dose) ComBe Five
      (Liquid), the first dose will be administered at 8-10 weeks of age.

      The frequency, rate and severity of immediate adverse events within 30 minutes after
      vaccination, solicited and unsolicited AE within 28 days after vaccination, the frequency and
      rate of SAE within 28 days after the first vaccination will be recorded as evidences for
      ComBeFive (Liquid) safety assessment. The subjects to be included from this trial would be
      representative of the population of Vietnam.

      The protocol has been reviewed and approved by Vietnam Military Medical University IRB and
      Vietnam Ministry of Health IEC and Vietnam Minister of Health.
    

Intervention name(s): ComBe Five (Liquid)
Intervention type(s): Biological
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: vaccine; ComBe Five; Vietnam; pentavalent
Open-label Study of Adalimumab in Japanese Subjects With Hidradenitis Suppurativa
Condition: Hidradenitis Suppurativa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study investigates efficacy, safety and pharmacokinetics of adalimumab in Japanese
      subjects with moderate to severe hidradenitis suppurativa (HS).
    

Detailed description: 
      Prior to initiation of this study, global Phase 2b study and pivotal Phase III studies were
      completed in the Western countries and market authorization of adalimumab was approved in
      United States (US) and European Union (EU) for the treatment of subjects with HS. The
      differences between this study and global studies include sample size, study design,
      duration, and race.
    

Intervention name(s): adalimumab
Intervention type(s): Drug
Intervention description(s): Subcutaneous Injection
Other intervention name(s): Humira
Intervention MeSH terms: Adalimumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: efficacy; safety; adalimumab; japanese participants
An RCT to Compare Early Continence Recovery After RARP With or Without Sustainable Functional Urethral Reconstruction
Condition: Prostate Cancer; Urinary Incontinence
MeSH terms: Prostatic Neoplasms; Urinary Incontinence; Enuresis
Study type: Interventional

Summary: 
      The study is a prospective randomized controlled trail to compare early urinary continence
      recovery after robotic-assisted radical prostatectomy with or without sustainable functional
      urethral reconstruction (SFUR).
    

Detailed description: 
      Early urinary incontinence has always been a tricky problem for both patients and urologists,
      even though over 90% patients can recover 1 year after surgery. Many urologists are trying to
      modify the surgical technique to resolve this problem. Sustainable functional urethral
      reconstruction (SFUR) is a novel technique which may improve early urinary continence
      recovery for both local and locally advanced prostate cancer, and even for those with high
      volume prostate by providing adequate urethral length with bladder neck tubularization and
      making sustainable periurethral support with peritoneal flap. The purpose of this study is to
      verify the impact of this new technique on early recovery of urinary continence, as well as
      on urinary function and oncological outcomes.
    

Intervention name(s): SFUR-RARP; Standard RARP
Intervention type(s): Procedure; Procedure
Intervention description(s): Robotic-assisted radical prostatectomy with sustainable functional urethral reconstruction (SFUR); Robotic-assisted radical prostatectomy with conventional RARP procedures.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Prostate cancer; Prostatectomy; Robotic surgery; Urinary incontinence; Sustainable functional urethral reconstruction