bioihbjkbjnl/mcl2 huggingface dataset:
Four-arm Mesh for Vaginal Stump Prolapse
Condition: Pelvic Organ Prolapse; Sexual Function Abnormal
MeSH terms: Prolapse; Pelvic Organ Prolapse
Study type: Interventional

Summary: 
      To estimate the safety and efficacy of performing modified anterior transvaginal mesh surgery
      using polypropylene mesh for treatment of advanced urogenital prolapse after hysterectomy
      (stage III and IV vc Pelvic Organ Prolapse Quantification [POP-Q] system staging).
    

Detailed description: 
      Pelvic reconstructive procedures were primarily performed using the transvaginal four arm
      polypropylene mesh, which was inserted through: upper arms- anterior part of obturator
      foramens, lower arms-ischiorectal fossas and sacrospinal ligaments. All patients underwent
      hysterectomy in the past apart from one which underwent vaginal hysterectomy during the
      procedure. Perineoplasty was performed additionally, if indicated. Subjective and objective
      evaluations included Pelvic Organ Prolapse Quantification [POP-Q] staging, preoperative and
      1-year postoperative questionnaires were performed.
    

Intervention name(s): 4-arm polypropylene mesh surgery; The Female Sexual Function Index (FSFI) questionnaire; King Health Questionnaire (KHQ); Pelvic Organ Prolapse Quantification (POPQ) staging; Postoperative questionnaire; The Short Form Health Survey (SF 36) questionnaire
Intervention type(s): Procedure; Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): Pelvic reconstructive procedures were performed with the use of 4-arm mesh:upper arms through- anterior part of obturator foramens, lower arms-ischiorectal fossas and sacrospinal ligaments.; patients fulfilled questionnaire before and 1 year after procedure; patients fulfilled questionnaire before and 1 year after procedure; Pelvic Organ Prolapse staging before and 1 year after the procedure; Postoperative questionnaire assessing quality of life fulfilled by patients 1 year after procedure; patients fulfilled questionnaire before and 1 year after procedure
Intervention model: Single Group Assignment
Intervention model description: Patients with vaginal stump prolapse who had undergone hysterectomy in the past
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: vaginal stump prolapse; sexual function; quality of life
ED Influenza Therapeutic Pilot Study: Oseltamivir vs. Peramivir
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      This pilot study is designed to demonstrate the feasibility of utilizing Emergency
      Departments (EDs) as a primary site for subject enrollment in clinical trials evaluating
      influenza therapeutics, and to provide pilot data for future clinical trial design and
      planning.

      Primary Objective: To prospectively enroll high-risk subjects with laboratory-confirmed
      influenza into a randomized, open label study of oral versus IV influenza therapeutic to
      include symptom evaluation and outcome assessments.

      Secondary Objective 1: To identify influenza positive patients utilizing a previously
      established triage-based assessment and rapid testing algorithm for suspected influenza
      infection.

      Secondary Objective 2: To retrospectively evaluate all potentially eligible patients for
      potential enrollment biases.

      Secondary Objective 3: To create a repository of residual nasopharyngeal samples collected
      from ED patients with suspected influenza illness.
    

Detailed description: 
      Title: A Pilot Randomized Controlled Trial for Feasibility of Enrolling Subjects for
      Influenza Therapeutic Trials and Administering Influenza Antivirals in the Emergency
      Department to High Risk Subjects

      Population: Adults presenting to the emergency department (ED) with laboratory confirmed
      influenza who meet Centers for Disease Control and Prevention (CDC) criteria for antiviral
      treatment

      Informed consent: Written informed consent

      Number of Sites: 2 - large, urban, academically-affiliated, US EDs

      Study Duration: November 2015 - June 2018

      Subject Participation Duration: 4 weeks

      Description of Agent or Intervention: Subjects will be randomized to either oral
      (oseltamivir) or intravenous (IV) (peramivir) antiviral treatment.

      Description of Study Design: This is an open-label randomized controlled clinical trial in
      which subjects with influenza are randomized to either oral (oseltamivir) or IV (peramivir)
      antiviral treatment.

      Estimated Time to Complete Enrollment: Subject enrollment will occur over two influenza
      seasons (November 2015 - April 2016 and November 2016 - April 2017) or longer, at the
      Principal Investigator's discretion, based on influenza prevalence.
    

Intervention name(s): Oseltamivir; Peramivir
Intervention type(s): Drug; Drug
Intervention description(s): Oral; IV
Note: Subjects admitted to the hospital directly from the ED Enrollment Visit may receive more doses at the discretion of the treating physician.
Other intervention name(s): Tamiflu; Rapivab
Intervention MeSH terms: Oseltamivir; Peramivir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Influenza; Antiviral treatment; Emergency department; Influenza therapeutics; Rapid influenza testing
Effect of Ishige Okamurae Extract on Musculoskeletal Biomarkers in Adults With Relative Sarcopenia
Condition: Sarcopenia
MeSH terms: Sarcopenia
Study type: Interventional

Summary: 
      The investigators conduct a randomized, double-blind, placebo-controlled study to investigate
      the effects of Ishige Okamurae extracts on muscle strength, muscle mass, and muscle function
      in adults with relative sarcopenia for 12 weeks.
    

Detailed description: 
      A previous study has indicated that Ishige Okamurae extracts may increase muscle mass and
      strength. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled
      study to investigate the effects of Ishige Okamurae extracts on muscle strength, muscle mass,
      and muscle function in adults with relative sarcopenia; the safety of the compound are also
      evaluated. The Investigators examine the peak torque/body weight at 60°/s knee extension,
      handgrip strength, skeletal muscle mass, physical performance, and metabolic parameters at
      baseline, as well as after 6 and 12 weeks of intervention. Eighty adults were administered
      either 300 mg of Ishige Okamurae extracts or a placebo each day for 12 weeks.
    

Intervention name(s): Ishige Okamurae extracts group; Placebo group
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Ishige Okamurae extracts 300 mg/day for 12 weeks; Placebo 300 mg/day for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Safety Study of Orally Administered Curcuminoids in Adult Subjects With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety of advancing doses of curcuminoids
      administered orally for fourteen consecutive days in adult subjects with cystic fibrosis (CF)
      who are homozygous for ΔF508 CFTR.
    

Detailed description: 
      The drug substance being studied is curcumin. Curcumin (diferuloylmethane) is a major
      constituent in the spice turmeric, which is used as a food worldwide.

      The pharmacologic rationale for studying curcumin for the treatment of cystic fibrosis is the
      potential for curcumin to help correct a deficiency of the cystic fibrosis transmembrane
      regulator (CFTR) protein. Cystic fibrosis results from a mutation of the CFTR gene, which
      produces abnormal CFTR protein that does properly transport chloride ion and water in the
      lung leading to abnormal mucus production. Curcumin is a potent inhibitor of the endoplasmic
      reticulum (ER) Ca2+ pump, and lowers ER calcium concentration. This may allow abnormal CFTR
      protein to function properly as a chloride channel and correct the cystic fibrosis defect. If
      this is successful, this effect could be measured as a decrease in the nasal potential
      difference (NPD) and sweat chloride in cystic fibrosis patients.

      The primary objective of this study is to assess the safety of advancing doses of
      curcuminoids administered orally for fourteen consecutive days in adult subjects with cystic
      fibrosis (CF) who are homozygous for ΔF508 CFTR. The secondary objectives are to obtain
      pharmacokinetic data for oral curcumoniods in CF subjects and to assess the effectiveness of
      curcuminoids to alter nasal potential difference (NPD) and seat chloride concentrations.
    

Intervention name(s): standardized turmeric root extract
Intervention type(s): Drug
Intervention description(s): 1.5 gm of standardized tumeric root extract three times per day for seven consecutive days, followed by 3 gm of standardized tumeric root extract three times per day for seven consecutive days
Other intervention name(s): AFI Curcuminoids
Intervention MeSH terms: Turmeric extract
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cystic Fibrosis; curcuminoids; turmeric root extract; nasal potential difference (NPD); sweat chloride
The Proximal Contact Tightness and Location in Class II Composite Restorations
Condition: Tooth Decay
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      This study aims to investigate consecutive biological changes in proximal contact tightness
      using digital force gauge and evaluate proximal contact location using cone beam computed
      tomography between class II direct composite restorations and adjacent teeth after using
      sectional matrix system and with different contact forming instruments.
    


Intervention name(s): Precontoured sectional matrix EZ COAT; PerForm™; AdDent Trimax™; Contact Pro™
Intervention type(s): Other; Other; Other; Other
Intervention description(s): All teeth will be treated with (Palodent ® plus sectional matrix system) (sectional matrix, biting ring, plastic diamond wedge); Treated with (PerForm™) as Contact Forming Instrument with (Palodent ® plus sectional matrix system); Treated with (AdDent Trimax™) as Contact Forming Instrument with (Palodent ® plus sectional matrix system); Treated with (Contact Pro™) as Contact Forming Instrument with (Palodent ® plus sectional matrix system)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study will be a randomized control clinical trial in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate the Pharmacokinetics and Safety Between HCP1902 and Co-administration of RLD2007, RLD2008
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetic characteristics and safety
      between HCP1902 and co-administration of RLD2007/RLD2008 in healthy volunteers
    


Intervention name(s): RLD2007; RLD2008; HCP1902
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Take it once per period.; Take it once per period.; Take it once per period.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Glutamate, Learning, and Working Memory
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      Impairments in plasticity and working memory in schizophrenia have been hypothesized to
      reflect dysfunction at the N-methyl-D-aspartate glutamate receptor (NMDAR). However, the
      specific mechanisms through which the NMDAR is involved in working memory versus plasticity
      differ. Towards gaining a deeper understanding of how NMDAR signaling relates to individual
      cognitive functions in healthy adults and patients with schizophrenia, the investigators used
      a single dose of d-cycloserine (DCS) as an experimental probe to examine the effects of
      enhancing NMDAR signaling on plasticity versus working memory in healthy adults and
      individuals with schizophrenia.
    

Detailed description: 
      Background: Cognitive impairments in schizophrenia, such as deficits in plasticity and
      working memory, have been hypothesized to reflect dysfunction at the N-methyl-D-aspartate
      glutamate receptor (NMDAR). However, given that divergent properties of the NMDAR underlie
      its roles in plasticity versus working memory and that various aspects of NMDAR function are
      abnormal in schizophrenia, examining the effects of DCS in both healthy and patient
      populations is crucial.

      Methods: The investigators used a single dose of the partial NMDAR agonist, d-cycloserine
      (DCS) to probe the effects of enhancing NMDAR signaling on working memory and plasticity.
      Working memory was assessed using a spatial n-back task. Plasticity was assessed using two
      learning tasks, the weather prediction task and information integration task, and an EEG
      paradigm that assesses changes in visual evoked potential amplitude following high frequency
      visual stimulation. Sixty-five healthy adults and forty-five schizophrenia patients were
      randomized to receive 100 mg acute DCS (healthy adult n = 32; schizophrenia n = 24) or
      placebo (healthy adult n = 33; schizophrenia n = 21).
    

Intervention name(s): D-cycloserine; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 100 mg D-cycloserine administered orally as encapsulated pill; Placebo administered orally as encapsulated pill
Intervention MeSH terms: Cycloserine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Receptors; N-Methyl-D-Aspartate
Efficacy of Intramuscular Naloxone 0.4mg. in Prophylaxis of Intrathecal Morphine Induced Pruritus After Cesarean Section
Condition: Morphine Adverse Reaction
MeSH terms: Pruritus
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether intramuscular naloxone 0.4mg. is effective
      in prophylaxis of intrathecal morphine induced pruritus after cesarean section.
    


Intervention name(s): naloxone; normal saline
Intervention type(s): Drug; Drug
Intervention description(s): naloxone 0.4mg.(1 ml) intramuscular; normal saline 1 ml IM
Other intervention name(s): narcan
Intervention MeSH terms: Naloxone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pruritus; intrathecal morphine
Reaching Out to Adolescents With Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      Major Depression is one of the most common mental health disorders in adolescence and is
      associated with significant impairments in development and functioning. This project will
      rigorously test the Adolescent Collaborative Care Treatment intervention, a health services
      intervention designed to improve management for depressive disorders among adolescents, via a
      randomized controlled trial comparing the intervention to usual care. Key components of the
      trial include enhanced education for youth and parents, youth involvement in choice of
      evidence-based treatments, care management by an allied health professional with regular
      supervision by a mental health specialist and pediatrician, and stepped care to advance
      treatment when youth are not improving. Additional features have been added to engage
      adolescents and parents including a moderated message board for youth to share with and learn
      from one another, formalized involvement of the parent, and availability of the care manager
      during after school hours. Our findings will provide key information on the effectiveness of
      a developmentally-sensitive adapted collaborative care intervention for the treatment of
      adolescent depression.
    


Intervention name(s): Collaborative care; Enhanced Usual Care
Intervention type(s): Other; Other
Intervention description(s): Provision of depression care management in the primary care setting to improve delivery of evidence based treatments; Provision of screening results to provider, teen and parent with recommendation to seek further care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Adolescents
Bioequivalency Study of Ranitidine Tablets 300 mg of Dr. Reddy's Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the rate and extent of absorption of ranitidine 300
      mg tablets versus Zantac 300 mg tablets administered as 1 x 300 mg tablet under fasting
      conditions.
    

Detailed description: 
      This study compared the rate and extent of absorption of ranitidine 300 rng tablets versus
      Zantac. The study products were administered as a single oral dose of 1 x 300 mg tablet using
      a randomized, two-way crossover fasting study in non-smoker healthy volunteers with a washout
      period of 7 days.
    

Intervention name(s): Ranitidine
Intervention type(s): Drug
Intervention description(s): Ranitidine Tablets, 300 mg
Other intervention name(s): Zantac 300 mg tablets of Glaxosmithkline
Intervention MeSH terms: Ranitidine; Ranitidine bismuth citrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Crossover; Ranitidine
Aortic Valve Dynamics During Exercise After Valve Sparing Root Replacement Surgery
Condition: Aneurysm Aortic Root; Aortic Valve, Bicuspid
MeSH terms: Aneurysm; Bicuspid Aortic Valve Disease; Aortic Aneurysm; Aortic Root Aneurysm
Study type: Interventional

Summary: 
      Aortic valve sparing operations are applied in patients with a non-calcified tricuspid or
      bicuspid aortic valve associated with a root aneurysm, in order to preserve the valve, and
      avoid new aortic dilatation by stabilizing the aortic valve anulus with a graft prosthesis.

      This results in a normal functioning aortic valve, with a low forward gradient across the
      left ventricular outflow tract.

      Little is known about how the repaired aortic valve behaves in conditions of controlled
      exercise, and how the gradients across the valve change during exercise.
    

Detailed description: 
      In a cohort of patients operated on since 2000 with a valve sparing operation for aortic root
      aneurysm in the Department of Cardiac surgery of the University Hospital Ghent, Belgium, and
      with gradients at rest across the aortic valve of <20mmHg, a graded exercise test on a
      bicycle (stepwise increase of afterload) will be performed, and the gradient across the
      aortic valve will be monitored by transthoracic echocardiography at each exercise level.
      Patients with tricuspid and bicuspid valves will be compared. An age matched, unoperated, and
      asymptomatic control group with normal functioning tricuspid and bicuspid valves will be
      examined with the same exercise protocol.

      The purpose of the study is the description of the gradients across the aortic valve during
      exercise, and the discrimination of risk factors that may induce increased gradients.

      The hypothesis is that patients with bicuspid valves will demonstrate higher gradients than
      patients with tricuspid valves, in operated and unoperated individuals.
    

Intervention name(s): graded bicycle test
Intervention type(s): Diagnostic Test
Intervention description(s): the subjects perform an exercise test on a reclining bicycle, and perform against increasing afterload
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: valve sparing procedure; reimplantation
Impact of Secukinumab on Clinical and Patient Reported Outcomes in Patients With Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Observational

Summary: 
      The study was conducted to describe the demographics, disease characteristics, disease
      severity, comorbidities and patient reported outcomes at baseline and follow-up periods among
      adult patients diagnosed with PsO in CorEvitas' PsO Registry under routine medical care
      initiating secukinumab (SEC).
    

Detailed description: 
      This is a retrospective analysis of a prospective observational cohort using CorEvitas' PsO
      registry of adult PsO patients. This study describes clinical and patient reported outcomes
      among adult patients initiating Secukinumab (SEC). Biologic experienced and naïve patients
      are examined separately. This study also describes changes in clinical and patient reported
      outcomes over time.

      CorEvitas' Psoriasis Registry is a prospective, observational cohort of adult PsO patients
      starting systemic therapy, launched in April 2015 with sites in the US and Canada. Data
      collection occurs every ~6 months at routine dermatology visits. This study included US PsO
      patients who initiated secukinumab at or after enrollment and had a subsequent 6- and/or
      12-month follow-up visit (Apr 2015 to Dec 2020).The index date is defined as the date of the
      first SEC initiation at or after enrollment.
    

Intervention name(s): Secukinumab
Intervention type(s): Drug
Intervention description(s): Patients with Psoriasis who initiated Secukinumab
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with psoriasis who initiated Secukinumab