bioihbjkbjnl/mcl2 huggingface dataset:
Imiquimod in Children With Plaque Morphea
Condition: Scleroderma, Localized
MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse; Scleroderma, Localized
Study type: Interventional
Phase: Phase 3

Summary: 
      Morphea is very hard to treat. In a small number of adult patients, Imiquimod has proven to
      be beneficial in decreasing the thickness of the morphea plaques , while improving their
      appearance. There are no studies to date proving its safety and efficacy in children with
      this disease. We propose to conduct a pilot study to assess to potential efficacy and
      relative safety of Imiquimod in children with plaque morphea.
    

Detailed description: 
      Design: Prospective, open label, pilot study

      Settings: The Hospital for Sick Children, Specialized Morphea Clinic

      Study population:

        -  Children 6-18 years of age

        -  Plaque morphea measuring less than 10 cm2 in diameter ( for children with multiple
           lesions, only one will be treated)

      Intervention: Topical imiquimod applied 3-5 times a week for 6 months

      Outcome measures: Decrease in the thickness of the skin by clinical scores and
      ultrasonography

      Duration of the study: 12 months ( 2 baseline visits, 1 intervention visit, 5 follow-up
      visits)
    

Intervention name(s): Imiquimod 5% cream
Intervention type(s): Drug
Intervention description(s): Treatment will last for 36 weeks. Patients will be instructed to apply Imiquimod three times per week for 4 weeks. If no local side effects are noted at the 4 week- follow-up visit, the frequency of the application will be increased to 5 weekly applications.
Intervention MeSH terms: Imiquimod
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: localized scleroderma; morphea; imiquimod; pediatrics
Study to Evaluate the Safety, Local and Systemic Tolerability, and Pharmacokinetics of Multiple-Dose Topical Administration of PF-07038124 in Japanese Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, skin irritation potential,
      and PK of PF-07038124 in Japanese healthy adult participants.
    


Intervention name(s): PF-07038124 or vehicle; PF-07038124 or vehicle
Intervention type(s): Drug; Drug
Intervention description(s): PF-07038124 0.01% or vehicle Ointment QD applied to 2000 cm2 Body Surface Area; PF-07038124 0.01% or vehicle Ointment QD applied to 4000 cm2 Body Surface Area
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Exercise Capability and Training Effects in Diabetic Patients With Neuropathy
Condition: Diabetes Mellitus; Peripheral Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetes Mellitus
Study type: Interventional

Summary: 
      The purpose of the study was to investigate the effects of training on the exercise
      capability, balance performance, and microcirculation. Furthermore, to search the possible
      underlying mechanisms.
    


Intervention name(s): exercise training; usual care
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes mellitus; Peripheral neuropathy; Exercise; Balance performance
Levobupivacaine During Cholecystectomy
Condition: Cholelithiasis; Pain
MeSH terms: Cholelithiasis; Cholecystolithiasis; Gallstones
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the effects of intraperitoneal administration of
      levobupivacaine on pain after laparoscopic cholecystectomy.
    


Intervention name(s): levobupivacaine
Intervention type(s): Drug
Intervention description(s): intraperitoneal administration of levobupivacaine on pain after laparoscopic cholecystectomy
Intervention MeSH terms: Levobupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: laparoscopic cholecystectomy
The Effect of the Core Stabilization Training on Respiratory Parameters , Functional Capacity and Balance in Scoliosis
Condition: Adolescent Idiopathic Scoliosis
MeSH terms: Scoliosis
Study type: Interventional

Summary: 
      The vertebral column is a structure that transfers the weight of the head and torso to the
      lower extremity, provides trunk movements and protects the spinal cord.A three dimensional
      deformity involving lateral flexion of the vertebrae in the frontal plane at 10 ° and above,
      including axial rotation and physiologic flexion (hypokyphosis) components in the sagittal
      plane, is defined as scoliosis. Adolescent idiopathic scoliosis (AIS) is a type of idiopathic
      scoliosis that occurs in the period from the onset of puberty (up to 10 years) until the
      closure of growth plates.

      Scoliosis is caused by postural, balance and neuromotor disorders as a primary cause of
      impaired sensory integrity, proprioceptive feedback deficits, secondary lung problems, organ
      disorders and pain. In addition, the quality of life in these individuals is also seen to
      decrease.Children with adolescent idiopathic scoliosis have inadequate respiratory function
      and a decrease in functional capacity. At the same time, these children show muscle weakness
      in certain parts of the body.

      The aim of this study was to investigate the relationship between home based core
      stabilization training, respiratory parameters, peripheral muscle strength, balance,
      functional capacity and quality of life in individuals with young scoliosis. The
      investigators suggest that the addition of core stabilization training to children with mild
      and moderate adolescent idiopathic scoliosis will produce good results.
    


Intervention name(s): Home Based Traditional Scoliosis Exercise; Home Based Core Stabilization Training
Intervention type(s): Other; Other
Intervention description(s): Program will include posture exercises, strengthening exercises of interscapular muscle and limb, diaphragmatic breathing exercises and stretching exercises for lumbar extensor, hip flexor, hamstring, pectoral muscles. Exercises will be applied 1 sets of 10 repetitions and once a day.; Program will include posture exercises, strengthening exercises of interscapular muscle and limb, diaphragmatic breathing exercises and stretching exercises for lumbar extensor, hip flexor, hamstring, pectoral muscles. In addition, the training group received core stabilization exercises for multifidus, transversus abdominis, diaphragm,erector spines, rectus abdominis, internal and external obliques, quadratus lumborum, gluteus maximus, and pelvic floor muscles.Exercises will be applied 1 sets of 10 repetitions and once a day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Adolescent idiopathic scoliosis; Scoliosis; Core Stabilization Training; Exercise Training; Pulmonary Function Test; 6 - Minute Walk Test; Peripheral Muscle Strength; Balance with Biodex; Quality of Life
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder (TPIP) in Healthy Participants
Condition: Healthy Volunteers
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to evaluate the safety and tolerability of single and
      multiple doses of treprostinil palmitil inhalation powder in healthy participants.
    


Intervention name(s): Treprostinil Palmitil Inhalation Powder; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral inhalation using a Plastiape capsule-based dry powder inhaler.; Oral placebo inhalation using a Plastiape capsule-based dry powder inhaler.
Other intervention name(s): INS1009
Intervention MeSH terms: Treprostinil
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Therapeutic Strategies During Exposure to Pain in an Experimental Design
Condition: Pain, Acute
MeSH terms: Acute Pain
Study type: Interventional

Summary: 
      The goal of the present study is to compare different therapeutic strategies (according to
      habituation model vs. according to the inhibitory learning approach) during exposure to
      thermal pain in an experimental design.
    

Detailed description: 
      Exposure therapy is effective for the treatment of individuals with chronic pain and high
      levels of fear-avoidance. Nevertheless, mechanisms of change for exposure treatment are not
      sufficiently investigated. According to the habituation model, the activation of a fear
      structure leads to a habituation of the initial physical response. Therefore, the therapeutic
      recommendation is to focus on the reduction of fear during exposure sessions. According to
      the inhibitory learning approach, however, exposure experiences compete with the original
      US-CS fear association. Therefore, the therapist should maximize the violation of negative
      expectancies. The present study intends to compare both strategies during the exposure to
      pain in an experimental design.
    

Intervention name(s): Exposure therapy (according to habituation approach); Exposure therapy (according to inhibitory learning approach)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Exposure instruction focuses on fear reduction during exposure sessions; Exposure instruction focuses on expectation violation during exposure sessions
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: participants are assigned to one of three experimental groups in parallel for the duration of the study
Masking: Single (Participant)
Primary purpose: Treatment
Pharmacodynamics, Safety, Tolerability and Pharmacokinetics of CDX-6114 in Patients With Phenylketonuria (PKU)
Condition: Phenylketonuria
MeSH terms: Phenylketonurias
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is an international, multi-center, randomized, double-blind, placebo-controlled,
      two-treatment, two-period cross-over study to evaluate the pharmacodynamics, safety,
      tolerability and pharmacokinetics of a single oral dose of CDX-6114 in patients with
      phenylketonuria (PKU).
    


Intervention name(s): CDX 6114; Matching Placebo
Intervention type(s): Drug; Other
Intervention description(s): CDX-6114 for oral administration is formulated in phosphate buffer, which also includes mannitol and poloxamer.The vehicle solution provided is identical to the CDX-6114 oral solution except for the active drug.; The placebo oral dosing solution will also be supplied as an approximately 240 mL oral solution and will be made up of the phosphate buffer diluent and the caramel flavoring.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Ultrasound Visceral Slide Test for Prediction of Periumblical Adhesions Before Gynecologic Laparoscopic Surgery
Condition: Periumbilical Adhesions
MeSH terms: Tissue Adhesions
Study type: Observational

Summary: 
      Ultrasound visceral slide test for prediction of periumbilical adhesions before gynecologic
      laparoscopic surgery: a prospective cohort study.

      The investigators are planning to conduct a prospective study to evaluate if there is an
      effect of abdominal wall thickness and body mass index on slide distance of visceral organ
      during ultrasound examination.
    


Intervention name(s): preoperative abdominal ultrasound examination
Intervention type(s): Diagnostic Test
Intervention description(s): Performing preoperative abdominal ultrasound examination in patients that will be scheduled for elective laparoscopic surgery for any gynecologic indication
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients scheduled for elective laparoscopic surgery for any gynecologic indication.
Bioequivalence Study of Rosuvastatin Tablet
Condition: Healthy Individuals
Study type: Interventional

Summary: 
      This study is designed to explore the bioequivalence of Test Product Vaptor (Rosuvastatin) 20
      mg Tablet with the reference product Crestor (Rosuvastatin) 20 mg tablet under fasting
      conditions in healthy Pakistani male subjects.
    

Detailed description: 
      This is a single-center, open-label, randomized, single-dose, two-period, two-way, cross-over
      study. Subjects will receive one single dose per treatment period of Test and Reference Drugs
      separated by a wash-out period of 7 days. Blood samples will be taken up to 72 hours
      post-dose. The primary pharmacokinetic parameters will be compared for both drugs to assess
      the bioequivalence.
    

Intervention name(s): Test Drug; Reference Drug
Intervention type(s): Drug; Drug
Intervention description(s): One single dose of Vaptor 20 mg will be administered to subjects after at least 10 hours fast together with 240 mL of ambient temperature water at their scheduled dosing time.; One single dose of Crestor 20 mg will be administered to subjects after at least 10 hours fast together with 240 mL of ambient temperature water at their scheduled dosing time.
Other intervention name(s): Vaptor 20 mg Tablet; Crestor 20 mg Tablet
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A single center, open label, randomized, single-dose, two period, two-way, cross-over study. Subjects will receive one single dose per treatment period separated by a wash-out period of 7 days.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bioequivalence Study
Ropivacaine After Sternotomy
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Continuous ropivacaine infusion to sternotomy wound after coronary artery bypass grafting
      (CABG) or heart valve surgery to diminish postoperative pain.
    

Detailed description: 
      A multiporous catheter will be introduced into sternotomy wound to CABG or heart valve
      surgery patients and continuous ropivacaine infusion 4 ml/h will be started immediately after
      surgery. Ropivacaine infusion will be administered during 48 postoperative hours. All
      patients receive patient controlled analgesia (PCA) oxycodone after extubation in the PACU.
      All patients receive a standardized anesthesia during surgery.
    

Intervention name(s): Ropivacaine
Intervention type(s): Drug
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Requirement of postoperative pain medication
Study of Treatment With the Combination of Drospirenone Plus Ethinyl Estradiol Plus Levomefolate Calcium in Mexican Women Seeking Contraception
Condition: Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to compare the red blood cell (RBC) and plasma concentrations
      of folate in subjects treated with drospirenone (DRSP)/ethinyl estradiol (EE) plus
      levomefolate calcium (L-5-MTHF) at 24 weeks with respect to basal determination.

      Increased intake of folic acid (synthetic form of the naturally occurring B-vitamin) before
      and in the first few weeks of pregnancy has been shown to reduce certain types of birth
      defects. This is important for women who may become pregnant following discontinuation of
      oral contraception. Information about any side effects that may occur will also be collected.
    


Intervention name(s): EE20/DRSP/L-5-MTHF (Beyaz, BAY98-7071)
Intervention type(s): Drug
Intervention description(s): One tablet DRSP 3 mg/EE 0.02 mg/ Levomefolate calcium 0.451 mg daily for 24 days, followed by one hormone-free tablet L-5-MTHF 0.451 mg daily for 4 days over 24 weeks
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Levomefolate calcium; Contraceptives, oral, combined; Neural tube defects
Effectiveness of Local Application of Warm Air in Patients With Common Cold (HELI Study)
Condition: Common Cold
MeSH terms: Common Cold
Study type: Interventional

Summary: 
      In a randomized controlled trial, the investigators include patients with beginning symptoms
      of a common cold and compare two interventions:

        1. the inhalation of warm air for inducing a warming of the throat and

        2. the inhalation of ambient air as control. As outcome the effect on symptoms and duration
           of the common cold will be assessed. The interventions will consist of visits with a
           duration of 2-3 minutes on three following days in a Finnish sauna. Patients will be
           fully dressed.
    


Intervention name(s): inhalation of warm air in a Finnish sauna; inhalation of ambient air in a Finnish sauna
Intervention type(s): Procedure; Procedure
Intervention description(s): three times on three following days, each 2-3 minutes; three times on three following days, each 2-3 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: common cold; Finnish sauna; rct
Effect of Bromfenac on Pain Related to Pterygium Surgery
Condition: Pterygium; Pain
MeSH terms: Pterygium
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the efficacy and ocular safety of bromfenac ophthalmic solution (bromfenac) 0.1%
      dosed twice daily for the treatment of ocular inflammation and pain after pterygium excision
      with amniotic membrane transplantation(AMT).
    

Detailed description: 
      Patients scheduled to undergo pterygium excision with AMT were randomized to receive added
      topical bromfenac or artificial lacrima at 3 days before and 7 days after the surgery. Pain
      intensity was evaluated with the visual analog scale(VAS) and present pain index(PPI) with
      the short form of the McGill Pain Questionnaire. psychological state used Self-rating of
      Depression Scale(SDS) and Self-rating of Anxiety Scale (SAS) to assess. Ocular inflammation
      was assessed with an automated bulbar redness grading technique. The irritative symptoms
      evaluation was carried out by an independent investigator at each visit with questionnaires
      of ocular symptom scores(OSS). Corneal epithelial healing rate was calculated after following
      up. All patients had follow-ups at the day 1, day 3, day7 and day 10.
    

Intervention name(s): 0.1% bromfenac
Intervention type(s): Drug
Intervention description(s): the patients received the use of the Ponacore 3 days before and 7 days after the operation. Local eye drops, 2 times a day.
Other intervention name(s): 0.5%Tobramycin dexamethasone; 0.3% sodium hyaluronate
Intervention MeSH terms: Tobramycin; Dexamethasone; Bromfenac; Hyaluronic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pterygium; Bromofenac; Pain
Study to Evaluate Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GX-E2 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, placebo controlled, single dose study to assess the safety,
      tolerability, pharmacokinetics and pharmacodynamics of GX-E2 in healthy male subjects.
    

Detailed description: 
      The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of
      GX-E2 when given as single dose (GX-E2 8 ug/kg) to healthy male subjects. Additionally,
      Immunogenecity will be evaluated to investigate antibody production.
    

Intervention name(s): GX-E2; GX-E2
Intervention type(s): Drug; Drug
Intervention description(s): Investigational drug(GX-E2 or Placebo) will be administered to healthy volunteers by the intravenous route.; Investigational drug(GX-E2 or Placebo) will be administered to healthy volunteers by the intravenous route.
Other intervention name(s): GC1113; GC1113
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Safety; Tolerability; Pharmacokinetics; Pharmacodynamics; Immunogenecity
Aspirin and the Risk of Microscopic Hematuria in Asymptomatic Screened Population
Condition: Asymptomatic General Population; Microscopic Hematuria
MeSH terms: Hematuria
Study type: Observational

Summary: 
      Aspirin can increase the risk of bleeding tendency. However, correlation between aspirin
      treatment and hematuria in general population is not well known. The investigators will
      evaluate whether daily use of aspirin increase the risk of microscopic hematuria in healthy
      large screened populations.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Asymptomatic general population who underwent general health screening program
      
Keywords: aspirin; screening; microscopic hematuria
A Study To Estimate The Time Course Of PF-00241939 Concentration In The Blood Following Dosing By Oral Inhalation From Dry Powder Inhalers.
Condition: Healthy
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the time course of PF-00241939 concentration in
      the blood following dosing by oral inhalation from dry powder inhalers.
    


Intervention name(s): Treatment A; Treatment B; Treatment C
Intervention type(s): Drug; Drug; Drug
Intervention description(s): PF-00241939 300ug using Inhaler A; PF-00241939 300ug using Inhaler B; PF-00241939 300ug using Inhaler C
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pharmacokinetics