bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy Study of Topical Ranpirnase to Treat Genital Warts (HPV)
Condition: Condylomata Acuminata; Papillomavirus Infections; Sexually Transmitted Diseases
MeSH terms: Sexually Transmitted Diseases; Papillomavirus Infections; Condylomata Acuminata
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Ranpirnase in topical formulation is an antiviral drug being evaluated for the topical
      treatment of anogenital warts. The aims of this study is to evaluate the efficacy and safety
      of a topical formulation of ranpirnase in subjects with genital warts.
    

Detailed description: 
      The study consists of the evaluation of 4 weeks exposure to the study product; designed as
      randomized, double blinded, against vehicle to study the effects of 1 mg/ml concentration of
      ranpirnase on anogenital warts.

      The dermal reaction are scored on a scale that describes the amount of erythema, edema, and
      other features indicative of irritation.

      The clinical response are be scored on the basis of the percentage of the reduction of the
      lesions in size and number.
    

Intervention name(s): Ranpirnase; Vehicle
Intervention type(s): Drug; Drug
Intervention description(s): Topical application by subject; Vehicle control
Other intervention name(s): Onconase; Placebo
Intervention MeSH terms: Ranpirnase
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Short-term Sunlight Exposure on Blood Pressure and Pulse Rate in Vitamin D3 Insufficient, Prehypertensive Patients
Condition: Sunlight Exposure
Study type: Interventional

Summary: 
      A three-period parallel (baseline, treatment, and post-treatment) design clinical research
      was conducted. All participants visited a clinical trial center of Korea University Anam
      Hospital for baseline measurement of clinical variables including ABPM and hematologic
      biomarkers (ACTH, aldosterone, norepinephrine, cortisol, and 25-hydroxyvitamin D3). After the
      baseline assessment, participants visited 'Cholipo beach' (Taean, Republic of Korea) for 3
      nights and 4 days for the intervention (sunlight exposure program). After a week of wash-out
      period, post-treatment measurement was processed at Korea University Anam Hospital.
      Participants were prohibited from vigorous physical activity, alcohol drinking, and smoking
      during the study period. A normal-sodium diet (2800 mg/day)[14], caffeine and smoking
      restriction was suggested during the whole study period. To control the effect of circadian
      rhythm on endocrine blood tests and ABPM, we fixed sampling and monitoring start time at
      10:00 am. All participants received the same measurements as they did in the baseline
      measurement during treatment and post-treatment periods.
    


Intervention name(s): Sunlight exposure
Intervention type(s): Other
Intervention description(s): The weather was sunny and found suitable for outside activity and sunlight exposure program, with a mean temperature of 27.0-28.5 °C, the humidity of 64-80%, and global solar exposure of 1.28 to 2.99 MJ/m2 during treatment.[15] Participants were asked to lie on the beach for 45 minutes per day between 2 to 3 pm to avoid extreme skin irritation and sunburn from direct sunlight exposure.
Intervention model: Single Group Assignment
Intervention model description: Single group parallel study
Masking: None (Open Label)
Primary purpose: Prevention
Evaluation of a Serious Game Aimed at Improving Mental Health in Youth.
Condition: Mental Health
Study type: Interventional

Summary: 
      The main goal of this study is to evaluate the effectiveness of a serious game aimed at
      improving mental health in teenagers aged 12-16 years old. This will test the effectiveness
      by studying the effect on emotion regulation strategies, coping strategies, the presence of
      cognitive errors and suicidal ideation. Participants will also be asked to evaluate the game.
      The study is a cluster-randomized controlled trial conducted in secondary schools in
      Flanders.
    


Intervention name(s): Silver
Intervention type(s): Behavioral
Intervention description(s): A serious game to improve mental health in youth
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Prevention
Keywords: Suicide Prevention; Universal Suicide Prevention; Serious Game
Emergency Department Longitudinal Integrated Care
Condition: Opioid-use Disorder; Emergency Department
MeSH terms: Emergencies; Opioid-Related Disorders
Study type: Interventional

Summary: 
      The overarching goal of this investigation is to develop and determine the feasibility of a
      multi-component intervention adapted from a collaborative care framework initiated in the ED
      for patients at risk for opioid use disorder. This study will provide important feasibility
      information for future studies of ED-LINC. The collaborative care intervention (ED-LINC) will
      be supported by a novel Emergency Departement (ED) health information exchange platform.
    

Detailed description: 
      The overarching goal of this investigation is to develop and determine the feasibility of a
      multi-component intervention adapted from a collaborative care framework initiated in the ED
      for patients at risk for opioid use disorder. According to the 2015 national survey on drug
      use and health, an estimated 3.8 million individuals over 12 years of age were currently
      misusing opioid pain relievers. An additional 329,000 people use heroin. The Emergency
      Department (ED) is currently at the forefront of this public health emergency and often a
      place where patients come for treatment of overdose and for treatment of medical problems
      related to illicit opioid use.

      Overall, the goal is to establish the feasibility of a multi-component intervention called
      'Emergency Department Longitudinal Integrated Care (ED-LINC)' which is guided by principles
      of collaborative care and is comprised of components that are evidence-based. ED-LINC is
      initiated from the ED and continues longitudinally for patients at-risk for opioid use
      disorder.
    

Intervention name(s): ED-LINC
Intervention type(s): Behavioral
Intervention description(s): ED-LINC will include 1) A brief negotiated interview at the bedside with an emphasis on motivation to link to services 2) Pharmacotherapy including a discussion of opioid safety, take-home naloxone and initiation of buprenorphine from the ED for participants that are interested and eligible; 3) Longitudinal care management which will proceed for 3-months; and 4) Care plan in the Emergency Department Information Exchange (EDIE) system. This will be coupled with a study cell phone and a weekly supervisory case conference which is consistent with collaborative care principles.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Opioid Use; Emergency Department; Collaborative Care
Outer Thigh Study With Varied Treatment Parameters
Condition: Body Fat Disorder
MeSH terms: Lipid Metabolism Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to compare the performance of a cryolipolysis system using
      various treatment parameters for non-invasive reduction of subcutaneous fat in the lateral
      thighs.
    


Intervention name(s): The Zeltiq System
Intervention type(s): Device
Intervention description(s): Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
Other intervention name(s): Cryolipolysis; Lipolysis
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Lipolysis; Cryolipolysis; Fat Reduction
Analysis of Competitive Posterior Cruciate Retaining (PCR) and Posterior Stabilized (PS) Total Knee Arthroplasty (TKA)
Condition: Knee Osteoarthritis; Total Knee Arthroplasty; Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Observational

Summary: 
      The purpose of the study is to acquire kinematic in vivo fluoroscopy data from subjects who
      were implanted with Stryker Posterior Cruciate Retaining (PCR) , Stryker Posterior Stabilized
      (PS), Zimmer PCR, and Zimmer PS Total Knee Arthroplasty (TKAs). Our lab has previously
      collected data for the Smith & Nephew PCR, bi-cruciate retaining (BCR), and bi-cruciate
      stabilized (BCS) TKA.
    

Detailed description: 
      The objective for this study is to analyze the in vivo kinematics for subjects implanted with
      either a Stryker PCR, Stryker PS, Zimmer PCR, and Zimmer PS TKA and to compare those patterns
      to subjects having a normal knee from our previous study and to those patterns from subjects
      having a Smith & Nephew PCR, BCR, and BCS TKA.
    

Intervention name(s): Triathlon PCR TKA; Triathlon PS TKA; Persona PCR TKA; Persona PS TKA
Intervention type(s): Device; Device; Device; Device
Intervention description(s): Total Knee Arthroplasty System; Total Knee Arthroplasty System; Total Knee Arthroplasty System; Total Knee Arthroplasty System
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients implanted with a Stryker Triathlon PCR, Stryker Triathlon PS, Zimmer Persona PCR,
        or Zimmer Persona PS total knee arthroplasty (TKA) implanted by Dr. Harold E. Cates.
      
Keywords: Total Knee Arthroplasty
A Pharmacokinetic Study of Single-Dose Intravenous Ustekinumab Delivered in 2 Different Liquid in Vial Formulations
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetic (PK) (blood levels)
      comparability of 2 different formulations of ustekinumab, 90 milligram per milliliter (mg/mL)
      liquid in vial (LIV) and 5 mg/mL LIV, following a single intravenous administration of 6
      milligram per kilogram (mg/kg) ustekinumab, diluted in saline, in healthy participants.
    

Detailed description: 
      This is a multicenter (when more than one hospital or medical school team work on a medical
      research study), randomized (study drug is assigned by chance), parallel (a clinical trial
      comparing the response in two or more groups of participants receiving different treatments),
      open-label (all people know the identity of the intervention) single-dose,
      inpatient/outpatient study in healthy participants. The study consists of following periods:
      Screening (within 28 days before study drug administration), inpatient period (Day 1 to 4)
      and outpatient period (up to Day 141). Eligible participants will be randomly assigned in a
      1:1 ratio to either 1 of 2 treatment groups (that is, Ustekinumab 90 mg/mL or Ustekinumab 5
      mg/mL) and will receive treatment on Day 1. The PK comparability of 2 different formulations
      of ustekinumab, diluted in saline, will be evaluated primarily. Participants' safety will be
      monitored throughout the study.
    

Intervention name(s): Ustekinumab; Ustekinumab
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive a single 6 milligram per kilogram (mg/kg) intravenous infusion of 90 milligram per milliliter (mg/mL) liquid in vial (LIV) formulation, diluted in saline, on Day 1.; Participants will receive a single 6 mg/kg intravenous infusion of 5 mg/mL LIV formulation, diluted in saline, on Day 1.
Other intervention name(s): STELARA®; STELARA®
Intervention MeSH terms: Ustekinumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Ustekinumab; STELARA®
Preoperative Carbohydrate Loading in Patients Undergoing Day-case Cholecystectomy
Condition: Preoperative Care
Study type: Interventional

Summary: 
      Background: Preoperative carbohydrate loading has been shown to reduce preoperative
      discomfort and postoperative nausea and vomiting in general surgical patients. Few studies
      have been focused on patients undergoing day-case surgery.

      Objective: The aim of this prospective randomized study was to determine whether preoperative
      carbohydrate loading enhanced the recovery of patients undergoing day-case cholecystectomy.

      Design: A randomised controlled trial. Setting: Secondary care in a district general and a
      university hospital in Finland between 2013-2016.

      Patients: A total of 113 patients ASA physical status I or II (18-70 yr) undergoing day-case
      cholecystectomy were included in the study. Exclusion criteria were bleeding or coagulation
      disorders, BMI >40, dementia, insulin-treated diabetes, migraine, Meniere's disease or a
      history of alcohol or drug abuse.

      Intervention: The carbohydrate rich drink (CHD) group received oral carbohydrate (200 ml) 2-3
      h before surgery, and the control (Fasting) group fasted from midnight according to standard
      protocol.

      Main outcome measures: Visual analogue scales (VAS) were used to score six discomfort
      parameters. The needs for analgesia or antiemetics, the time to drinking, eating and first
      mobilization after surgery, and the time to discharge and hospital readmission were recorded.
    


Intervention name(s): carbohydrate rich drink
Intervention type(s): Dietary Supplement
Intervention description(s): The carbohydrate rich drink (CHD) group received oral carbohydrate (200 ml) 2-3 h before surgery,
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Carbohydrate loading, oral carbohydrate beverage
Sudapyridine (WX-081) in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to evaluate the safety, tolerability as well as
      pharmacokinetics of Sudapyridine (WX-081) in Chinese volunteers.
    

Detailed description: 
      In this study, a single-center, randomized, double-blind, placebo-controlled, dose-ascending
      design was used to evaluate the safety, tolerability and pharmacokinetic characteristics of
      Sudapyridine (WX-081) tablets in healthy Chinese subjects using placebo as control.

      This study was divided into two stages. The first stage evaluated the tolerance of single
      administration, pharmacokinetic characteristics, and the effect of food on PK. The second
      stage evaluated the tolerance of multiple administration and PK characteristics.
    

Intervention name(s): Sudapyridine 30mg; Sudapyridine 100mg SAD; Sudapyridine 200mg SAD; Sudapyridine 200mg MAD; Sudapyridine 300mg MAD; Placebo tablet SAD; Placebo 200mg SAD; Placebo tablet MAD; Placebo tablet MAD
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Other; Other; Other; Other
Intervention description(s): Sudapyridine capsule 30mg, orally, single dose; Sudapyridine tablet, 100mg orally, single dose; Sudapyridine tablet, 200mg orally, single dose; Sudapyridine tablet, 200mg orally once a day for 14 days; Sudapyridine tablet, 300mg orally once a day for 14 days; Placebo tablet, 100mg orally, single dose; Placebo tablet, 200mg orally, single dose; Placebo tablet, 200mg orally once a day for 14 days; Placebo tablet, 300mg orally once a day for 14 days
Other intervention name(s): Sudapyridine capsule 30mg SAD; Sudapyridine tablet 100mg SAD; Sudapyridine tablet 200mg SAD; Sudapyridine tablet 200mg MAD; Sudapyridine tablet 300mg MAD; Placebo tablet 100mg; Placebo tablet 200mg MAD; Placebo tablet 300mg MAD
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy of Repetitive Transcranial Magnetic Stimulation in Reducing Cocaine Intake in Addicted Patients
Condition: Cocaine Use Disorder
Study type: Interventional

Summary: 
      The study evaluates the efficacy of 3 weeks of repetitive transcranial magnetic stimulation
      (rTMS), 5 sessions/weekly, in reducing cocaine consumption immediately after and within the 8
      weeks following the treatment in addicted patients with cocaine use disorders (CUD) versus
      placebo.
    

Detailed description: 
      40 patients are expected and randomized in two groups: 20 patients with active rTMS and 20
      with placebo rTMS.

      Visit 1: 15 days (3 weeks of 5 consecutive daily sessions and 2 days of rest) 15Hz rTMS is
      performed during the following days in addition to a biweekly urine drug test and VAS
      evaluation.

      Visit 2: Changes from baseline to week 8 in cocaine intake. Evaluation of craving and of
      other assessments like mood and quality of life.
    

Intervention name(s): rTMS
Intervention type(s): Other
Intervention description(s): rTMS is a non-invasive and safe brain stimulation technique, that uses a magnetic pulse, administrated through a coil, set on the DLPFC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: rTMS; Craving; Mood and cognitive behavior; Substance-Related Disorders
A Study to Assess the Safety, Tolerability, and Efficacy of Long-term SOBI003 Treatment in Pediatric MPS IIIA Patients
Condition: Sanfilippo Syndrome Type A (MPS IIIA)
MeSH terms: Mucopolysaccharidosis III
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      MPS IIIA, also known as Sanfilippo A, is an inherited lysosomal storage disease (LSD). MPS
      IIIA is caused by a deficiency in sulfamidase, one of the enzymes involved in the lysosomal
      degradation of the glycosaminoglycan (GAG) heparan sulfate (HS). The natural course of MPS
      IIIA is characterized by devastating neurodegeneration with initially mild somatic
      involvement. The aim of the present study is to assess the safety, tolerability and efficacy
      of long-term SOBI003 treatment. SOBI003 is a chemically modified recombinant human (rh)
      Sulfamidase developed as an enzyme replacement therapy (ERT).
    

Detailed description: 
      This is an open, single-arm, multicenter extension study to assess the safety, tolerability
      and efficacy of long-term SOBI003 treatment in pediatric MPS IIIA patients. The study is an
      extension of the First in Human (FIH) SOBI003-001 study, allowing continuous treatment of
      SOBI003 for up to 2 years. Study patients who complete Week 24 of the FIH study (SOBI003-001)
      will be invited to continue to Week 25 in the extension study.

      When entering the extension study, these patients will receive the highest dose that has been
      declared safe in the ongoing FIH study (SOBI003-001). Upon completion of the FIH study, an
      analysis aimed at selecting the dose for forthcoming studies will take place. Once the dose
      has been selected, this dose will be applied to all patients enrolled in the extension study.
      The total duration of the extension study for an individual patient is 80 weeks, resulting in
      a total of 104 weeks (2 years) of SOBI003 treatment.
    

Intervention name(s): SOBI003
Intervention type(s): Drug
Intervention description(s): weekly i.v. infusion
Other intervention name(s): Modified recombinant human sulphamidase
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Antitussive Effect of Single-dose Dexmedetomidine With Low-dose Remifentanil Infusion
Condition: Thyroidectomy
Study type: Interventional
Phase: Phase 4

Summary: 
      After thyroid surgery, the incidence and severity of coughing is important because it may
      cause serious complications, such as bleeding in the surgical field, laryngospasm, and
      cardiovascular disturbance. Several studies have shown that the single-dose of
      dexmedetomidine is effective for reducing cough and agitation during emergence from general
      anesthesia.

      To test the hypothesis that single-dose of dexmedetomidine combined with a low-dose
      remifentanil infusion during emergence from general anaesthesia could reduce coughing as good
      as high-dose remifentanil infusion, we will evaluate the efficacy on cough suppression and
      reduction of side effect of remifentanil using non-inferiority trial.
    


Intervention name(s): Dexmedetomidine + Remifentanil-low dose; Remifentanil-high dose
Intervention type(s): Drug; Drug
Intervention description(s): single dose administration (0.5mcg/kg) 10 min before end of the surgery with maintain the infusion of remifentanil (TCI 1 ng/ml) until end of surgery; maintain the infusion of remifentanil until end of the surgery (TCI 2 ng/ml)
Other intervention name(s): Precedex; Ultiva
Intervention MeSH terms: Dexmedetomidine; Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention