bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Oasis® Wound Matrix on Stage III and IV Trunk Pressure Wounds Treated With Negative Pressure Wound Therapy
Condition: Open Wound Abdominal Wall; Wound Non Healing
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      This study evaluates the therapeutic effect of Oasis® Matrix along with Negative Pressure
      Wound Therapy (NPWT) on pressure wounds. Either Oasis or standard foam will be applied to the
      wound prior to activating the NPWT.
    

Detailed description: 
      In this study, patients being treated with Negative Pressure Wound Therapy (NPWT) will be
      randomized to receive either:

        1. Oasis® matrix, applied to the wound, along with standard of care including NPWT OR

        2. Standard foam, applied to the wound prior to activation of NPWT, which is standard care.

      Wounds will be examined weekly for up to 12 weeks. At weeks 4, 8, and 12, the NPWT evacuation
      canister will be collected for specimen analysis.

      The aim of this study is to determine the therapeutic effect of using Oasis® Wound Matrix
      with NPWT. Outcomes include: a) closure rate of non-healing wounds, and b) levels of growth
      factors and interleukins in fluid evacuated from the wound.
    

Intervention name(s): NPWT Standard of Care plus Oasis wound product; Routine NPWT Standard of Care
Intervention type(s): Device; Device
Intervention description(s): Oasis® is a porcine acellular small intestine submucosa material compatible with human tissue. It is a complex scaffold that provides optimal environment for restoration of tissue structure. It guides tissue growth and traps growth factors. Oasis Matrix indications include partial and full thickness wounds and skin loss injuries as well as second-degree burns.; Specialized material, often foam, designed to protect the wound and promote healing during NPWT.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Assessing the Efficacy of Maxidex® and Patanol® for the Treatment of Allergic Conjunctivitis
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to evaluate the efficacy of Maxidex and Patanol compared to
      placebo in patients with allergic conjunctivitis when exposed to controlled allergen levels
      in an Environmental Exposure Chamber (EEC).
    

Detailed description: 
      This study consisted of 6 visits. Visit 1 was the Medical Screening Visit (skin prick test).
      Visit 2 and Visit 3 consisted of 2 consecutive EEC Visits (3 hours in the EEC followed by 7
      hours in the Clinic, 10 hours total, each visit) followed by 7 days of wash-out. Visit 2 and
      Visit 3 occurred prior to dispense and the measures obtained during these visits were used as
      baseline. At Visit 4 patients were randomized and dispensed the assigned study medication for
      7 days of at-home dosing. Visit 5 (Day 8 of treatment) and Visit 6 (Day 9 of treatment)
      consisted of 2 additional consecutive EEC Visits (3 hours in the EEC followed by 7 hours in
      the clinic, 10 hours total, each visit). During each EEC visit, patients were exposed to
      either ragweed or cat allergen, depending on their skin prick test results. Of the 180
      participants enrolled, 170 received at least one dose of study treatment and were randomized
      to one of the three study treatments.
    

Intervention name(s): Dexamethasone 0.1% ophthalmic suspension; Olopatadine hydrochloride 0.1% ophthalmic solution; Inactive ingredients, used as placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Maxidex; Patanol; Tears Naturale II
Intervention MeSH terms: Olopatadine Hydrochloride; Dexamethasone; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: Conjunctivitis; ocular allergy
Study to Evaluate Safety and Efficacy of CCX 354-C in Subjects With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of multiple oral doses
      of CCX354-C at a number of dose levels in subjects with stable rheumatoid arthritis (RA).
    

Detailed description: 
      This randomized, double-blind, placebo-controlled Phase I/II study will consist of two
      sequential stages, Stage A and B. This protocol describes the objectives, design, and
      procedures for Stage A of the study. The protocol will be amended in future when sufficient
      data from Stage A have been collected to initiate Stage B. The protocol amendment will
      describe the objectives, design, and procedures for Stage B of the study.

      Stage A will be a randomized, double-blind, placebo-controlled, multi-dose, sequential dose
      escalation sub-study in 24 subjects with stable RA. Three sequential dose cohorts of 8
      subjects will be included in this stage:

        -  Cohort 1: 100 mg CCX354-C or placebo

        -  Cohort 2: 100 mg CCX354-C or placebo

        -  Cohort 3: 200 mg CCX354-C or placebo

      Safety and PK data from each cohort will be reviewed by a data monitoring committee
      (DMC)before dose escalation to the next dose level. The study will proceed to Stage B only if
      the safety and tolerability profile of Stage A is deemed acceptable by the DMC.
    

Intervention name(s): CCX 354-C
Intervention type(s): Drug
Intervention description(s): Cohort 1: Eight subjects will be randomized to receive 100 mg CCX354-C or placebo in a ratio of 3:1 (CCX354-C:placebo) once daily for 14 days;
Cohort 2: Eight subjects will be randomized to receive 100 mg CCX354-C or placebo in a ratio of 3:1 (CCX354-C:placebo) twice daily for 14 days; and
Cohort 3: Eight subjects will be randomized to receive 200 mg CCX354-C or placebo in a ratio of 3:1 (CCX354-C:placebo) once daily for 14 days.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Combined Drug Therapy in Lateral Fragility Fractures of the Femur
Condition: Femur Fracture
MeSH terms: Fractures, Bone; Femoral Fractures
Study type: Observational

Summary: 
      It was conducted a prospective study with a series of 50 patients treated by intramedullary
      nail using Clodronic acid and Vitamin D (study group including 25 patients) and patients with
      the same fractures treated with Vitamin D alone (control group including 25 patients).

      One independent observer performed clinical, biochemical and functional evaluations at T0
      (1st day post-surgery) and at T1 (12 months later) Biochemical markers (serum calcium level,
      serum phosphate level, PTH (parathormone), Vitamin D, serum C-terminal telopeptide), VAS
      (Visual Analogic Scale) and HHS (Harris Hip Score) score, and femur densitometric views were
      administered at each evaluation.
    


Intervention name(s): Clodronic Acid
Intervention type(s): Drug
Intervention description(s): Osteoporotic fracture treated with surgical and medical therapy
Intervention MeSH terms: Clodronic Acid
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Fifty (50) patients referring to the Orthopaedic and Trauma Unit of the local University
        Hospital between May 2019 and March 2020 with lateral fragility fracture were prospectively
        recruited.
      
Keywords: fragility lateral femoral fractures; bisphosphonates; clodronic acid; bone density
Effect of Severe Renal Impairment on Pharmacokinetics and Metabolism of a Single Administration of Licarbazepine
Condition: Healthy
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the influence of severe renal impairment on the pharmacokinetics of
      licarbazepine and its glucuronide conjugate after single oral administration in healthy
      subjects and in subjects with stable impaired renal function.
    


Intervention name(s): Licarbazepine
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Open-label study, healthy subjects, stable impaired renal function, licarbazepine, pharmacokinetics, metabolism, safety.
Sinuclean Nebules 45 for Treatment of Pediatric Exudative Otitis Media
Condition: Otitis Media With Effusion
MeSH terms: Otitis; Otitis Media; Otitis Media with Effusion
Study type: Interventional
Phase: Phase 3

Summary: 
      The goal of the study is to investigate if the active agent of Sinuclean Nebules is
      efficacious in the treatment of pediatric exudative otitis media, comparing with saline.

      Sinuclean Nebules is a solution of cucurbitacins B,D,I,E (glycosylated triterpenes) 45 mcg,
      extracted from Ecballium Elaterium.
    

Detailed description: 
      Eligible pediatric subjects with diagnosis of mono or bi-lateral exudative otitis media
      (obtained with otorhinolaryngologic endoscopic examination, tympanogram and tonal
      audiometry), are randomized to treatment with Sinuclean Nebules 45 or saline.

      Treatment is administered by trained caregiver with nebulizer (Rinowash Nasal Shower): one
      nebulization/nostril/day for two cycles of 10 consecutive days. Cycles are interrupted by a
      period of 7 days.

      Visits 1 Baseline T0: confirmation of eligibility, randomization, training of caregiver,
      dispensation of blinded therapy for two cycles, delivery of the clinical diary.

      Visit 2 after 10 days of therapy + 7 days of interval: phone call to check for adverse
      events, therapy adherence, concomitant diseases and treatments, and to prescribe second cycle
      of therapy.

      Visit 3 End of Study: assessment of the exudative otitis media with otorhinolaryngologic
      endoscopic examination, tympanogram tonal audiometry, verification of the subject's clinical
      diary.
    

Intervention name(s): Sinuclean Nebules 45; Saline solution
Intervention type(s): Device; Other
Intervention description(s): Nebulization of solution; Nebulization of solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Otitis Media with Effusion; Exudative otitis media
Progression of Diabetic Retinopathy. Identification of Signs and Surrogate Outcomes
Condition: Diabetic Retinopathy
MeSH terms: Retinal Diseases; Diabetic Retinopathy
Study type: Observational [Patient Registry]

Summary: 
      Progression of Diabetic Retinopathy. Identification of Signs and Surrogate outcomes
      (PROGRESS)
    

Detailed description: 
      The global aim of this study is to improve the current knowledge of diabetic retinopathy (DR)
      progression. We aim to characterize both functionally and morphologically initial DR stages
      and to identify patients at risk of progression to centre involving macular oedema (CME)
      and/or proliferative diabetic retinopathy (PDR). We want to identify imaging patterns and
      characteristics that might be used as prognostic biomarkers for DR progression.

      For this, ischemia and blood-retinal barrier alteration will be assessed using non-invasive
      retinal imaging methodologies. SD-OCT with layer-by-layer segmentation will be performed.
      Furthermore, a state-of-the-art methodology with OCT-Angiography will be used for
      identification of areas of capillary drop-out and leakage areas will be identified on SD-OCT
      without the need of a dye injection. In a subgroup of patients we will study
      neurodegeneration patterns using multifocal ERG examination.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Any patients followed under the normal clinical practice at AIBILI Clinical Trial Centre.

        - Type 2 diabetes mellitus according to 1985 WHO criteria
Psychoeducation for the Parents of Attention Deficit Hyperactivity Disorder (ADHD) Children
Condition: ADHD
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      This study designed and evaluated a psychoeducation program for parents of ADHD children in
      terms of improving medication adherence and clinical benefits.
    

Detailed description: 
      ADHD is the most common behavioral disorder with poor outcomes. Medication is the most
      important treatment for ADHD. The adherence to the medication is extremely low. This study
      aims to investigate the the effect of a psychoeducation program for parents of ADHD children.
      The investigators intent to recruit 80 ADHD families. They will be randomized to intervention
      group and control group using a block randomization design. The intervention group will
      participate in a psychoeducation program, which includes a presentation from a specialist in
      ADHD at the baseline, with parent manual provided, posters, and two group sessions at the end
      of the 2nd and the 4th weeks. The control group only receives general consultation. The
      knowledge towards ADHD and its treatment, parents' behavior intent, medication adherence,
      clinical symptoms, and parents' satisfaction will be assessed and compared at the end of the
      1st and 3rd months after intervention.
    

Intervention name(s): psychoeducation
Intervention type(s): Behavioral
Intervention description(s): The intervention included a presentation by a psychiatrist, with parent manual provided, and then two group sessions at the 2nd and 4th weeks to address further concerns of the parents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Supportive Care
Asthma Clinical Research Network (ACRN) Trial - Long-Acting Beta Agonist Response by Genotype (LARGE)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to determine whether regularly scheduled use of an inhaled
      long-acting beta agonist (salmeterol) in the setting of concomitant use of inhaled
      corticosteroids (beclomethasone hydroflouroalkane (HFA) inhaler) will have a detrimental
      effect on asthma control in people who bear the B16-Arg/Arg genotype of the beta-2 adrenergic
      receptor gene, as compared to people with asthma of similar severity who bear the B16-Gly/Gly
      genotype.
    

Detailed description: 
      BACKGROUND:

      The purpose of this study is to compare the effects of a long-acting beta agonist in patients
      with asthma receiving inhaled corticosteroids who express two distinct polymorphisms of the
      beta-2 adrenergic receptor.

      DESIGN NARRATIVE:

      Participants were homozygous for arginine or glycine at the 16th amino-acid position of the
      β-2 adrenergic receptor (B16 Arg/Arg or B16 Gly/Gly). Individuals were matched against their
      opposite genotype by forced expiratory volume in one second (FEV1) and race. Matched
      participants entered an 8-week run-in period. This is a 62-week crossover design where
      subjects receive the following therapies:

        -  Beclomethasone HFA (240 µg twice a day (BID)) + as-needed (PRN) albuterol: 8-week run-in

        -  Beclomethasone HFA (240 µg BID) + salmeterol (50 µg BID) + PRN ipratropium bromide + PRN
           albuterol: 18-week treatment period

        -  Beclomethasone HFA (240 µg BID) + PRN albuterol: 8-week run-out

        -  Beclomethasone HFA (240 µg BID) + placebo salmeterol + PRN ipratropium bromide + PRN
           albuterol: 18-week treatment period

        -  Beclomethasone HFA (240 µg BID) + PRN albuterol: 10-week run-out

      The order of treatments received during the two treatment periods is randomized.
    

Intervention name(s): salmeterol; beclomethasone HFA
Intervention type(s): Drug; Drug
Intervention description(s): 50 micrograms (mcg) twice per day (BID) (Serevent 50 mcg diskus, GlaxoSmithKline (GSK), North Carolina); 240 mcg beclomethasone HFA (QVAR, Teva Pharmaceutical Industries)
Other intervention name(s): Serevent; QVAR
Intervention MeSH terms: Beclomethasone; Salmeterol Xinafoate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of LY3361237 in Participants With Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to learn more about the safety and tolerability of
      LY3361237 and any side effects that might be associated with it when given to participants
      with psoriasis. LY3361237 will be administered by injections just under the skin. The study
      will last up to 41 weeks and may include up to 15 visits to the study center.
    


Intervention name(s): LY3361237; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC; Administered SC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Pharmacokinetic Study of the Vaginal Microbicide Agent 1% Tenofovir Gel
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multi-center, pharmacokinetic study involving a single-dose phase, a wash out phase
      and a two-week once or twice-daily dosing phase for each of 49 volunteers.

      In the single-dose phase, each volunteer will apply the single dose in the clinic.
      Participants will be randomized to have cervicovaginal samples and biopsies collected at one
      of seven time-points [0.5, 1, 2, 4, 6, 8, and 24 hour(s)] after the single-dose. Blood
      samples will be drawn at 0.5, 1, 2, 4, 6, 8, and 24 hour(s) after the single-dose.

      In the two-week phase, the study supplies will be distributed and the participants will be
      randomized to apply each dose either once or twice-daily for two weeks. At the one week
      follow-up visit a blood sample will be drawn prior to the morning dose to obtain a trough
      value and cervicovaginal samples will be collected four hours after the morning dose. At the
      two week follow-up visit blood samples will be drawn prior to the morning dose to obtain a
      trough value and then at 0.5, 1, 2, 4, 6, 8, and 24 hour(s) from the final morning dose.
      Participants will be randomized to have cervicovaginal samples and biopsies collected at
      either 4, 8 or 24 hours after the final morning dose.

      Up to 10 participants who have completed the first two phases of the study, will be asked to
      participate in a third phase to have cervicovaginal samples, biopsies and blood samples
      collected 12 hours after a single-dose.
    


Intervention name(s): Tenofovir gel
Intervention type(s): Drug
Intervention description(s): Intravaginal (4grams)single dose followed by fourteen days
Other intervention name(s): 9-[(R)-2-(phosphonomethoxy)propyl] adenine or PMPA
Intervention MeSH terms: Tenofovir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: HIV prevention; Microbicides; Pharmacokinetics; vaginal biopsies
A United States Extension Study of Corlux for Recurrent Psychotic Symptoms in Psychotic Major Depression
Condition: Depressive Disorder, Major
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Mental Disorders; Psychotic Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      Corlux (mifepristone) is a new medication that modulates the body's use of a hormone called
      cortisol. Under normal conditions, cortisol and other hormones are created by the body in
      response to physical and emotional stress, triggering a healthy stress response. People who
      suffer from psychotic major depression may have unusually high levels of cortisol circulating
      within them or abnormal patterns of cortisol levels, overloading the stress response
      mechanism and causing symptoms of psychosis such as delusional thoughts or hallucinations. If
      Corlux can keep the body's cortisol receptors from being overloaded, the stress response
      system may return to normal function, which may result in improvement of symptoms. The
      purpose of this study is to allow patients who have already participated in an earlier 8 week
      study of Corlux versus placebo (an inactive pill) to receive additional courses of treatment
      with Corlux periodically if a psychotic episode should reappear during a period of one year.
    


Intervention name(s): Mifepristone
Intervention type(s): Drug
Intervention MeSH terms: Mifepristone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depression; Major Depression; Psychotic Major Depression; PMD; Psychosis
Use of Internet Mediated Walking Program and Pedometer in COPD
Condition: COPD
Study type: Interventional

Summary: 
      Persons with COPD are randomized to pedometer versus pedometer plus Internet mediated website
      to promote walking and physical activity. Primary outcome is daily step counts. Intervention
      lasts 3 months.
    


Intervention name(s): Internet mediated walking program
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment