bioihbjkbjnl/mcl2 huggingface dataset:
Sun Protection Factor Assay (317/2016)
Condition: Sunscreening Agents
Study type: Interventional

Summary: 
      To evaluate the Sun Protection Factor efficacy on human skin.
    


Intervention name(s): BAY987521; SPF Control
Intervention type(s): Drug; Drug
Intervention description(s): Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Code: Z09-174); Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of GSK573719 (LAMA) and GW642444 (LABA)Administered Individually and Concurrently in Healthy Japanese Subjects
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      GW642444 is a potent and selective long-acting beta2 agonist; GSK573719 is a long-acting,
      inhaled, muscarinic receptor antagonist (or anticholinergic) bronchodilator. Both are in
      development as once daily (QD) monotherapies for the treatment of Chronic Obstructive
      Pulmonary Disease (COPD). Development of these two inhaled drugs as a combination therapy is
      also planned and would have potential for improved efficacy and patient benefit as they both
      work through different receptor pathways and the combined bronchodilatory effect might be
      additive.

      This study is a randomised, double blind, placebo-controlled, four-way crossover study which
      will assess the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of
      GSK573719 and GW642444 in sixteen healthy Japanese subjects. Subjects will receive four
      possible treatments as single inhaled doses, receiving the two monotherapies separately, the
      monotherapies concurrently, and placebo.

      Blood samples for PK analysis will be taken at regular intervals after dosing. Safety will be
      assessed by measurement of heart rate, blood pressure, ECG and twenty-four hour Holter
      monitoring, potassium, safety laboratory data and review of adverse events.
    


Intervention name(s): GSK573719
Intervention type(s): Drug
Intervention description(s): GSK573719 is a long-acting, inhaled, muscarinic receptor antagonist or anticholinergic bronchodilator. GW642444 is a potent and selective long-acting beta-2 agonist. Both are in development for once daily monotherapies for the treatment of COPD. In this study, their effects are investigated following individual and concurrent administration.
Other intervention name(s): GW642444
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: safety; LAMA; pharmacodynamics; tolerability; Muscarinic receptor antagonist,; anticholinergic,; beta-2 agonist; healthy Japanese subjects; LABA; Chronic Obstructive Pulmonary Disease (COPD); pharmacokinetics
Enpatoran Human Mass Balance and Absolute Bioavailability Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of Period 1 of this study is to provide a definitive quantitative
      characterization of the mass balance, and rates and routes of excretion of enpatoran, and to
      determine and quantify enpatoran and its metabolites in excreta (urine and feces) and plasma.
      The purpose of Period 2 of this study is to determine the absolute oral bioavailability of
      enpatoran. Total minimum duration of study participation for each participant is
      approximately 50 days.
    


Intervention name(s): Enpatoran; [14C]enpatoran microtracer; [14C]enpatoran microdose
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive single oral dose of enpatoran tablet on Day 1; Participants will receive single oral dose of non-labeled enpatoran solution spiked with microtracer of [14C]enpatoran on Day 1 of Period 1.; Participants will receive intravenous [14C]enpatoran microdose administered at 1.5 hours after the oral dose of enpatoran on Day 1 of Period 2.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Microtracer; Microdose; Clinical Pharmacology
Effects of Diaphragmatic Manual Therapy in Chronic Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      This study is a double-blind randomized clinical trial with two arms which aims to study the
      effects of diaphragmatic treatment in patients with nonspecific low back pain.

      Low back pain has a great importance in today's society, and it is therefore important to
      develop an effective treatment for this condition. People with chronic nonspecific low back
      pain, can present respiratory disorders and get anxiety states, affecting mainly the
      diaphragm muscle. Therefore, given its direct anatomic relationship, the diaphragm may be
      part of the development of chronic low back pain. Although clinical practice guidelines for
      chronic low back pain have been developed, it hasn't been explored before a physiotherapy
      treatment especially aimed at a diaphragmatic treatment.

      A double-blind randomized clinical trial with two arms will be used for this purpose, 64
      patients with nonspecific low back pain referred from different hospitals of Castellón will
      be randomized into two groups:

        -  Diaphragmatic intervention with osteopathic manual therapy treatment (D).

        -  Diaphragmatic intervention with placebo treatment group (P).

      An osteopathic manual therapy protocol for the treatment of back pain including techniques
      for the diaphragm muscle will be applied to the patients in group D, in a total of 5
      sessions. For patients in group P, the same protocol will be performed on the diaphragm but
      with placebo treatment techniques.

      The study focuses on the analysis of the following variables: scores on the questionnaires:

        -  Pain: McGill Pain Questionnaire and VAS (Visual Analogical Scale ).

        -  Fear Avoidance: (FABQ)

        -  Disability: Oswestry Disability Index and Roland-Morris

        -  Anxiety: HADS: (Hospital Anxiety and Depression Scale)

        -  Catastropizing: PCS (Pain Catastropizing Scale)

        -  Satisfaction with treatment (Escala de Satisfacción con el tratamiento)

      The results of these pre-intervention and post-intervention variables will be compared
      between the two groups in the first session, in the fourth session and in the first and third
      month after the first intervention. The VAS score will also be assessed in the second and
      third session.
    


Intervention name(s): manual therapy with diaphragmatic treatment; Placebo treatment
Intervention type(s): Other; Other
Intervention description(s): Subjects receive five sesions of manual therapy for low back pain combined with diaphragmatic treatment.; Subjects receive five sesions of manual therapy for low back pain combined with a sham diaphragmatic treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: diaphragm; osteopathic treatment; myofascial release
Upper Limbs Assessment in Children With Cerebral Palsy
Condition: Cerebral Palsy; Children
MeSH terms: Paralysis; Cerebral Palsy
Study type: Observational

Summary: 
      Cerebral palsy is the leading cause of physical disability among children. Manual dexterity
      and upper limbs functionality is limited between these children. The purpose of this study is
      to stablish a specific profile of school children with cerebral palsy based on the upper
      limbs assessment.
    

Detailed description: 
      While the rates of perinatal and infant mortality have declined toward the end of the last
      century,the rate of cerebral palsy has remained at 2 to 2.5 per 1,000 live births. A high
      percentage of children with cerebral palsy have difficulty keeping up with the handwriting
      demands at school. The neurological impairments in children with cerebral palsy frequently
      limit the functionality of these children taken in to account the upper limbs variables. It
      should be interesting to describe a clinical profile based on this assessment.
    

Intervention name(s): Assessment
Intervention type(s): Other
Intervention description(s): The children with cerebral palsy were assessed. Different measures evaluating the upper limbs functionality are used.
Other intervention name(s): Evaluation; Description
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        School children with cerebral palsy.
      
Keywords: functionality; Cerebral palsy; Handwriting
1% Metformin Gel in the Treatment of Class II Furcation Defects
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis; Furcation Defects
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Metformin (MF), a biguanide group of anti-diabetic drug has been shown to enhance osteoblasts
      differentiation and inhibit osteoclast differentiation in vitro, thus may exhibit a
      favourable effect on alveolar bone. The present study aims to explore the efficacy of 1% MF
      gel as a local drug delivery system in adjunct to scaling and root planing (SRP) for the
      treatment of Class II furcation defects in comparison with placebo gel.
    

Detailed description: 
      Background: Metformin (MF), a biguanide group of anti-diabetic drug has been shown to enhance
      osteoblasts differentiation and inhibit osteoclast differentiation in vitro, thus may exhibit
      a favourable effect on alveolar bone. The present study aims to explore the efficacy of 1% MF
      gel as a local drug delivery system in adjunct to scaling and root planing (SRP) for the
      treatment of Class II furcation defects in comparison with placebo gel.

      Methods: Sixty four patients with single mandibular buccal class II furcation defects were
      categorized into two treatment groups: SRP plus 1% MF (group 1) and SRP plus placebo (group
      2). Clinical parameters were recorded at baseline, 3 months, 6 months, and 9 months, and
      radiographic parameters were recorded at baseline, 6 months, and 9 months. Defect fill at
      baseline, 6 months, and 9 months was calculated on standardized radiographs using image
      analysis software.
    

Intervention name(s): SRP and placebo; SRP and 1% metformin
Intervention type(s): Drug; Drug
Intervention description(s): Placement of placebo gel into classII furcation defects after scaling and root planing; Placement of 1% metformin gel into classII furcation defects after scaling and root planing
Other intervention name(s): Group 1; Group 2
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Phase III Trial of Febuxostat in Korea Gout Patients
Condition: Gout
MeSH terms: Gout
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was designed to evalute the efficacy and safety of Febuxostat after oral
      administration to patientd with gout in Korea
    

Detailed description: 
      This is a multi-center, randomized, double-blind, allopurinol and placebo controlled,
      parallel, 5 arms, dose response, bridging study of 4 weeks duration.

      If subjects pass the screening evaluation after submitting a signed informed consent, they
      will be randomly assigned to one of the five treatment regimens; febuxostat 40mg, 80mg,
      120mg, placebo or allopurinol 300mg. Colchicine 0.6mg QDis given to minimize the risk of gout
      flares during the washout/run-in period and during the double study period.
    

Intervention name(s): Febuxostat
Intervention type(s): Drug
Intervention MeSH terms: Febuxostat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Technology-Assisted Cholesterol Trial in Consumers (TACTiC)
Condition: High Cholesterol
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this AUS is to evaluate the extent to which participants can safely and
      effectively self-select, purchase, and use Crestor OTC 5 mg for a 6-month period according to
      the label.
    

Detailed description: 
      This is a single-arm, interventional, phase III Self-Selection (SS) and Actual Use Study
      (AUS) using a technology assisted tool within a Web App. The open-label study will enroll
      approximately 1220 participants who qualify for treatment based on the data they enter into
      the Web App of which an estimated 1000 participants will ultimately proceed to the use phase.
    

Intervention name(s): 5 mg rosuvastatin calcium with a Web App (combination product)
Intervention type(s): Combination Product
Intervention description(s): The combination product will be a Drug (Rosuvastatin calcium 5 mg) and Software as a Medical Device (Web App that features a Technology-Assisted Self-Selection (TASS) tool). Rosuvastatin calcium 5 mg will be taken orally, 1 tablet daily to use for lowering cholesterol, a key risk factor that can lead to heart disease.
Other intervention name(s): Crestor 5 mg
Intervention MeSH terms: Rosuvastatin Calcium; Calcium
Intervention model: Single Group Assignment
Intervention model description: This is a 6-month, single-arm, uncontrolled technology-assisted Self-Selection and Actual Use Study to evaluate the use of nonprescription rosuvastatin 5 mg in combination with a Web App. It is an open-label study where participants qualify for treatment based on the medical history, laboratory and blood pressure data they enter into the Web App, accessed on their own device on the internet.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cholesterol, Web App
Assessment of an Alternative Model of Follow-up of Children and Adolescents With Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of the study is to look at the effect of replacing the physician only visit by a
      transmission of information on the participant's current diabetes management and blood
      glucose monitoring results followed by a phone contact by the diabetes nurse educator. The
      study will also measure the effect on diabetes control (HbA1c), satisfaction with care,
      resource utilisation, and costs to the health care system and to the participant.

      We hypothesize that replacement of the physician-only visit by a virtual visit will not
      result in worsening of the medical outcomes and that it will result in a reduction in medical
      resources utilization and costs for families while increasing the satisfaction with care.
    

Detailed description: 
      Improved metabolic control reduces both the onset and progression of diabetes-related
      complications in adults and adolescents with type 1 diabetes. Frequency of contact with the
      medical care team has been associated with better control. Both the American Diabetes
      Association and Canadian Diabetes Association recommend regular quarterly visits. However,
      the increase in case loads and the limited manpower available forces us to look at
      alternative models of care. A model of care in which medical visits alternate between a face
      to face multidisciplinary visits and a virtual visit done via fax or e-mail communication and
      a phone call may be advantageous to both the patient and the medical care team. For the
      patient and his family, this model would decrease time away from school and work, travel
      inconveniences and costs. For the medical care team it may decrease time per patient and
      therefore increase the number of patients served with the same resources.
    

Intervention name(s): Virtual visit
Intervention type(s): Other
Intervention description(s): Participants will alternate between a multidisciplinary visit (MD, RN and RD) and a phone contact with the diabetes nurse educator (the phone contact will replace the physician-only visit). Prior to the phone contact, transmission of information from the participant will be sent through either fax or a web browser.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Type 1 Diabetes; Telemedicine; Children
Use of v Care in Abdominal Hysterectomy
Condition: Uterine Fibroid
MeSH terms: Leiomyoma
Study type: Interventional

Summary: 
      The investigators use v care during abdominal hysterectomy and evaluate its effect on
      duration of operation time, surgical complications and vaginal length.
    


Intervention name(s): uterine manipulator (v care)
Intervention type(s): Device
Other intervention name(s): v care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Study to Investigate the Efficacy and Safety of Two Dose Levels of NT 201 Versus Placebo in Treating Chronic Troublesome Sialorrhea in Various Neurological Conditions
Condition: Chronic Troublesome Sialorrhea; Parkinson's Disease; Post-stroke; Traumatic Brain Injury
MeSH terms: Sialorrhea; Parkinson Disease; Brain Injuries; Brain Injuries, Traumatic
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to investigate the efficacy and safety of two different dose
      levels of NT 201 (75 U or 100 U per cycle), compared with placebo, in reducing the salivary
      flow rate, and the severity and frequency of chronic troublesome sialorrhea that occurs as a
      result of various neurological conditions in adult subjects.
    


Intervention name(s): IncobotulinumtoxinA (100 Units); IncobotulinumtoxinA (75 Units); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).; Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).; Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
Other intervention name(s): Xeomin; NT 201; Botulinum toxin type A (150 kiloDalton), free from complexing proteins; Xeomin; NT 201; Botulinum toxin type A (150 kiloDalton), free from complexing proteins
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA; incobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Performance of 2WIN Photoscreener With Corneal Reflex Compared to School Bus Retinoscopy by AAPOS Guidelines
Condition: Refractive Errors; Amblyopia; Strabismus; Development Delay
MeSH terms: Amblyopia; Strabismus; Refractive Errors
Study type: Observational [Patient Registry]

Summary: 
      Pediatric eye patients receive infrared photoscreener screening and skiascopy as a part of
      routine examination to compare ability to detect amblyopia risk factors.
    

Detailed description: 
      Patients: Pediatric eye and adult strabismus patients undergoing routine examinations in a
      private ophthalmology practice.

      Interventions: Infrared photoscreener / remote autorefractor such as 2 Winner (2WIN)
      ("Adaptica" - Padova, Italy) without and with infrared corneal reflex occluder.
      Child-friendly skiascopy before and after cycloplegic refraction.

      Outcome: Amblyopia Risk Factors from comprehensive eye exam including refraction and
      strabismus.

      Risk factors defined by American Association for Pediatric Ophthalmology and Strabismus
      (AAPOS) 2003 and 2013 guidelines.

      **Please note that 2 Winner has nothing to do with actual device, but was required by the
      Clinical Trials Web entry.**
    

Intervention name(s): 2WIN photoscreener
Intervention type(s): Device
Intervention description(s): conventional infrared off-axis photoscreener
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        male and female children and adults with strabismus developmental delay is NOT excluded
CT/MR-US Automatic Fusion System in Pre-procedure Planning for Radiofrequency Ablation
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma, Hepatocellular
Study type: Interventional

Summary: 
      To prospectively evaluate the technical success rate of real-time computed
      tomography/CT/magnetic resonance imagingMR and -ultrasound (CT/MRI-US) automatic fusion
      system and the long-term therapeutic efficacy of radiofrequency ablation (RFA) guided by
      automatic fusion in hepatocellular carcinoma (HCC) patients.
    

Detailed description: 
      RFA is one of commonly used local therapies for primary or secondary liver tumors. For
      successful and safe procedure, safe route of electrode and lesion visibility are essential
      for RFA, and the conditions are usually evaluated on pre-RFA planning ultrasonography (USG).
      However, RFA is sometimes aborted due to limited sonic window of various cause and
      challenging identification of small isoechoic tumors or hepatocellular carcinomas among
      dysplastic nodules . Therefore, precise targeting and assuring safe route would be of
      clinical importance. In this preliminary study, investigators attempted to determine
      automatic US and CT/MR fusion technique would be able to improve RFA feasibility in patients
      with liver tumors.
    

Intervention name(s): automatic CT/MRI-US fusion system guided radiofrequency ablation
Intervention type(s): Procedure
Intervention description(s): automatic CT/MRI-US fusion system guided radiofrequency ablation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Radiofrequency ablation; Fusion imaging
A Study in Healthy Japanese Men to Test How Different Doses of BI 690517 Are Taken up in the Body and How Well They Are Tolerated
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the trial is to investigate the safety and tolerability of BI 690517
      in healthy Japanese male subjects following oral administration of multiple rising doses over
      14 days.

      Secondary objective is the exploration of the pharmacokinetic(s) (PK) and pharmacodynamic(s)
      (PD) of BI 690517 in healthy Japanese male subjects after multiple dosing.
    


Intervention name(s): BI 690517; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 3 sequential dose groups; 3 sequential dose groups
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment