bioihbjkbjnl/mcl2 huggingface dataset:
Irritation and Sensitization Potential of Repeat Applications of Rotigotine Patch
Condition: Bioequivalence - Irritation and Sensitization Potential of Transdermal Patch
Study type: Interventional
Phase: Phase 1

Summary: 
      STUDY TITLE:

      A Multiple Site Study to Evaluate the Irritation and Sensitization Potential of Repeat
      Applications of Rotigotine Transdermal System, 1 mg/24 hr Versus Neupro (Rotigotine
      Transdermal System), 1 mg/24 hr in Healthy Volunteers

      TEST DRUG / INVESTIGATIONAL PRODUCT:

      Rotigotine Transdermal System, 1 mg/24 hr

      INDICATION STUDIED:

      Bioequivalence - Irritation and Sensitization

      STUDY DESIGN:

        -  Multiple-site, randomized, multiple-application, evaluator-blinded, controlled study

        -  One-half (½) of the test patch and one-half (½) of the reference patch was applied daily
           to the same site for each product over a 21 day period followed by a rest phase and a
           challenge phase
    


Intervention name(s): Rotigotine Transdermal System
Intervention type(s): Drug
Other intervention name(s): Neupro
Intervention MeSH terms: Rotigotine
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Phase 1 Study to Assess Single and Multiple Ascending Doses of PBI-100 Topical Cream
Condition: Healthy Volunteers; Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized, double-blind, vehicle-controlled, SAD / MAD study evaluating
      three dose levels of PBI-100 topical cream in healthy adult volunteers and/or subjects with
      psoriasis.
    

Detailed description: 
      This is a Phase 1, randomized, double-blind, vehicle-controlled, SAD / MAD study. Three dose
      levels of PBI-100 topical cream will be evaluated in healthy adult volunteers and/or subjects
      with psoriasis. Dose escalations will follow a satisfactory review by the Safety Review
      Committee of all available safety, tolerability, and PK data from the current dose level.
    

Intervention name(s): PBI-100 Topical Cream; Vehicle Cream
Intervention type(s): Drug; Drug
Intervention description(s): PBI-100 Topical Cream in 1 of 3 dose levels; The Vehicle Cream formulation contains the same excipients as the active cream
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pilot Pharmacokinetic Clenil Study With AeroChamber Plus™ or Volumatic™ Spacer Devices
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate, at steady-state, the systemic exposure and the lung
      deposition of B17MP (active metabolite of BDP) as AUC0-12h,ss and Cmax,ss, after inhalation
      of BDP (Clenil® Modulite®) with the AeroChamber Plus™ spacer device or with the Volumatic™
      spacer device without or with charcoal block.
    


Intervention name(s): Clenil® Modulite® via AeroChamber Plus™; Clenil® Modulite® via Volumatic™ spacer; Clenil® Modulite® via AeroChamber Plus™ plus charcoal block; Clenil® Modulite® administered via Volumatic™ spacer plus charcoal block
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Clenil® Modulite® 250 µg via AeroChamber Plus™ spacer during 14 days; Clenil® Modulite® 250 µg via Volumatic™ spacer during 14 days; Clenil® Modulite® via AeroChamber Plus™ spacer during 14 days (plus charcoal block at Day 14); Clenil® Modulite® administered via Volumatic™ spacer during 14 days (plus charcoal block at day 14)
Intervention MeSH terms: Charcoal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Asthma; PK; Adults
Health Benefits of Repeated Treatment in Pediatric Schistosomiasis
Condition: Schistosomiasis
MeSH terms: Schistosomiasis
Study type: Observational

Summary: 
      Objective and Hypotheses: This project has the overall objective of implementing and
      evaluating new approaches to reducing the current and future burden of urinary
      schistosomiasis in young children using the antihelminthic drug praziquantel. The
      investigators hypotheses are that (1) praziquantel treatment will be as effective in children
      1 to 5 years of age (who are routinely excluded from schistosomiasis control programmes) as
      it is in older 6-10 year old children and (2) two treatments will be more effective than a
      single treatment, especially in children 1 to 5 years of age.
    

Detailed description: 
      This study aims to address the present health inequity by refinement of an existing drug
      regimen to improve the current and future health of pre-school children and infants.
      Praziquantel is cheap, highly efficacious and safe, presenting a realistic opportunity of
      using a pre-existing tool in a modified way to benefit child health and development. The
      study will focus on children aged 1 to 10 years of age, comparing the impact of single vs.
      double treatment with PZQ on the current and future health status of the children. The
      immediate health benefits of PZQ treatment in children aged 6-10 years of age have already
      been documented and therefore by including 6-10 year olds in the proposed study, we can
      determine if the effects of PZQ treatment on health and morbidity measures is age dependent.
      By killing worms PZQ stops the morbidity related to the presence of worms and eggs such as
      anaemia, abdominal pain, diarrhoea and blood in the urine. Therefore the study will
      investigate the immediate health benefits of treating pre-school children and infants.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Zimbabwean children
      
Keywords: paediatric schistosomiasis morbidity immunology
The VEPRO Trial: A Cross-Over Randomised Controlled Trial Comparing 2 Corrective Lenses for Patients With Presbyopia
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional

Summary: 
      The VEPRO trial is a cross-over randomised controlled trial comparing 2 corrective lenses for
      patients with presbyopia. The aim of the study is to compare the effectiveness of two
      corrective lenses: an old generation (Varilux Comfort Orma Crizal) and a new generation
      (Varilux Panamic Orma Crizal) of corrective lenses prescribed in presbyopia.
    


Intervention name(s): a new generation of corrective lens for presbyopia (i.e., Varilux Panamic Orma Crizal); an old generation of corrective lens for presbyopia (i.e., Varilux Comfort Orma Crizal)
Intervention type(s): Device; Device
Other intervention name(s): VARILUX PANAMIC ORMA CRIZAL; Essilor (R); VARILUX COMFORT ORMA CRIZAL; Essilor (R)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of the Contribution of Basketball-specific Target Shooting Exercises to Strength, Position Sense, Stability and Endurance in Young Basketball Players
Condition: Open Kinetic Chain Proprioception Exercises
Study type: Interventional

Summary: 
      The aim of this study is to examine the effects of open kinetic chain proprioception
      exercises on joint position sense, strength, functional stability and endurance in adolescent
      basketball players
    

Detailed description: 
      Adolescent basketball players, aged 13-16, were randomly divided into two groups as exercise
      group (n = 11) and control group (n = 11). Exercise group performed open kinetic chain
      functional proprioception exercises twice a week for 6 weeks. Control group did not
      participate in any exercise program. Before and after the exercise program all athletes were
      subjected to the proprioception test and isokinetic muscle strength test on the isokinetic
      dynamometer, closed kinetic chain upper extremity stability test and modified push-up test.
    

Intervention name(s): Open Kinetic Chain Proprioception Exercises
Intervention type(s): Other
Intervention description(s): basketball-specific target shooting in open kinetic chain
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Proprioception; strength; stability; endurance; adolescent basketball player
Efficacy and Safety Study of AI201901 in Allergic Rhinitis Patients
Condition: Allergic Rhinitis Due to Allergens
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a prospective, national, randomized, multicenter, parallel group, Phase III study
      that evaluates the effects of AI201901 in Allergic Rhinitis patients, where they will spray
      twice a day against azelastine into both nostrils during a 28-day follow-up period.
    


Intervention name(s): AI201901; Azelastine Hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): Twice daily inhaled AI201901 for 4 weeks; Twice daily inhaled Azelastine Hydrochloride for 4 weeks
Other intervention name(s): Allergodil
Intervention MeSH terms: Azelastine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The first group will receive AI201901 , whereas the second group will receive azelastine hydrochloride. Patients that will receive AI201901 are defined as the test arm and patients that will receive azelastine hydrochloride are defined as the active control arm.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Allergic Rhinitis
A Trial on Laparoscopic Appendectomy Versus Single Port Appendectomy
Condition: Acute Appendicitis
MeSH terms: Appendicitis
Study type: Observational

Summary: 
      The aim of this study is to compare patients who undergone single-port access laparoscopic
      appendectomy to those who underwent conventional three-port laparoscopic appendectomy (TPLA)
      in a prospective randomized trial
    

Detailed description: 
      -  primary objective

           1. complication rate

        -  secondary objectives

             1. satisfaction rate

             2. pain scale difference
    

Intervention name(s): single port appendectomy, three port appendectomy
Intervention type(s): Procedure
Intervention description(s): visual analog scale. questionnaire on wound satisfaction
Other intervention name(s): Pain scale; Satisfactory score; complication rate
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The cohorts will be the residents of Incheon, Korea
      
Keywords: appendectomy; appendicitis; laparoscopic surgery
The Efficacy of Interferential Current Treatment on Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The effects of different carrier frequencies of interferential current on pain and function
      in patients with knee arthrosis will be compared
    

Detailed description: 
      60 patients with knee osteoarhthritis will be enrolled in the study. Subjects will be
      randomized to 3 groups. All patients will receive interferential currents to both their
      knees, with different carrier frequencies (2, 4 and 8 kilohertz (kHz) respectively). The
      effect of different types of carrier frequencies on pain, 10 meter walk test will be
      analysed.
    

Intervention name(s): Interferential current
Intervention type(s): Device
Intervention description(s): An electrotherapy current with different carrier frequencies
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: interferential current; knee osteoarthritis; pain
Surgical Excision and Intralesional Steroid Injection for Prevention of Post Caesarean Keloid Recurrence
Condition: Keloid
MeSH terms: Keloid; Recurrence
Study type: Interventional
Phase: Phase 4

Summary: 
      Two groups of patients (73 patients each) undergoing routine caesarean section has recurrent
      keloid at site of surgical scar. One group will undergo surgical excision of keloid. The
      other group will have combined surgical excision of keloid and single intralesional
      dexamethasone injection at edges of wound.All patients were reviewed once per month for 6
      months for evidence of recurrence
    

Detailed description: 
      One hundred forty six patients that are admitted at Kasr Al Aini teaching university hospital
      for caesarean section, will be enrolled in this randomized clinical trial after approval by
      the local ethical health committee. A written informed consent will be obtained from each
      participant after full explanation of the procedure.

      Under general or spinal anaesthesia done routinely during caesarean section, total
      extralesional surgical excision of the keloid is performed and minimal undermining followed
      by the usual steps of caesarean section. Primary closure of the wound in layers is achieved
      in all cases. A running subcuticular prolene 2/0 stitch is used to suture the skin. Group A
      of 73 patients will not receive further injection. In 73 patients (group B), the wound edges
      are injected once with dexamethasone. A 1 mL syringe with a 30-gauge needle is used and
      injection is both intradermal and subdermal. Repeated alternate punctures are used to bathe
      the wound edges with the drug. Approximately 0.5-1 mL of dexamethasone (4 mg/mL) in wound
      tissue.

      For all patients, the wound is painted with betadine and sealed until postoperative day 14,
      at which time the subcuticular stitch is removed.

      Postoperative medications are given to all patients in the form of analgesics and antibiotics
      as routinely given at the hospital. All patients were advised to avoid direct sun exposure
      for the following month. No postoperative applications (eg, compression, steroid injections,
      etc) were used in any of the patients. All patients were reviewed once per month for 6
      months.
    

Intervention name(s): Dexamethasone; surgical excision
Intervention type(s): Drug; Other
Intervention description(s): the wound edges are injected once with dexamethasone. A 1 mL syringe with a 30-gauge needle is used and injection is both intradermal and subdermal. Repeated alternate punctures are used to bathe the wound edges with the drug. Approximately 0.5-1 mL of dexamethasone (4 mg/mL) in wound tissue.; total extralesional surgical excision of the keloid is performed and minimal undermining
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: recurrent keloid; surgical excision; steroids injection
Combination Chemotherapy in Treating Patients With Advanced or Metastatic Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug may kill more tumor cells.

      PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy in
      treating patients who have advanced or metastatic colorectal cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the efficacy of different schedules of irinotecan in combination with
           capecitabine as first-line therapy, in terms of objective response rate, in patients
           with advanced or metastatic colorectal cancer.

        -  Compare the time to treatment failure, time to progression, and overall survival of
           patients treated with these regimens.

        -  Compare the safety profile, in terms of toxicity, of these regimens in these patients.

        -  Determine the quality of life in patients treated with these regimens.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
      performance status (0 vs 1); disease symptoms, including pain, weight loss, loss of appetite,
      malaise, and fever of unknown origin (yes vs no); weight loss during the past 6 months (more
      than 5% vs 5% or less); and disease-free interval (more than 6 months vs 6 months or less).
      Patients are randomized to 1 of 2 treatment arms.

        -  Arm I: Patients receive irinotecan IV over 1 hour on days 1, 8, 15, 22, and 29 and oral
           capecitabine twice daily on days 1-14 and 22-35.

        -  Arm II: Patients receive irinotecan IV over 1 hour on days 1 and 22 and oral
           capecitabine as in arm I.

      Treatment in both arms repeats every 6 weeks in the absence of disease progression or
      unacceptable toxicity.

      Quality of life is assessed at baseline, on day 1 of each course, and at the first visit
      after treatment failure.

      Patients are followed every 12 weeks for 1 year and then every 6 months thereafter.

      PROJECTED ACCRUAL: A total of 28-74 patients (14-37 per treatment arm) will be accrued for
      this study.
    

Intervention name(s): Irinotecan 70 mg/m2; Irinotecan 240 mg/m2
Intervention type(s): Drug; Drug
Intervention description(s): Irinotecan i.v. 70 mg/m2, day 1, 8, 15, 22, 29; Irinotecan i.v. 240 mg/m2 day 1 and day 22
Intervention MeSH terms: Irinotecan
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage III colon cancer; stage IV colon cancer; stage III rectal cancer; stage IV rectal cancer
Vapocoolant (Pain Ease) Use for Venipuncture
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      To determine the efficacy and safety of vapocoolant spray (Pain Ease Medium Stream) in
      decreasing the pain of venipuncture ("blood draw")
    

Detailed description: 
      This is a prospective, randomized, blinded, comparator study. This study design is considered
      standard for establishing safety and efficacy data. Active treatment vapocoolant spray (Pain
      Ease Medium Stream) spray) will be used. There will be a placebo (sterile water) in this
      study. The population selected for this study, adults (excluding the very old, > 80 years
      old) represents a patient population that may benefit from vapocoolant spray. This is a
      patient population that according to the treating health care provider already requires
      venipuncture for "blood draw" but not intravenous cannulation. Because venipuncture is a
      painful procedure, vapocoolant may confer benefit for the relief of pain.
    

Intervention name(s): Vapocoolant (Pain Ease); Nature's Tears Sterile Water
Intervention type(s): Device; Device
Intervention description(s): Topical stream 4-10 seconds duration to skin.; Topical stream 4-10 seconds duration to skin
Other intervention name(s): Pain Ease Stream
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Vapocoolant
Physical and Mental Assessment of Older Patients With Newly Diagnosed Acute Myeloid Leukemia
Condition: Cognitive/Functional Effects; Depression; Leukemia
MeSH terms: Leukemia; Depression
Study type: Observational

Summary: 
      RATIONALE: Learning about physical ability and mental function over time in older patients
      with acute myeloid leukemia may help doctors learn about the long-term effects of treatment
      and plan the best treatment.

      PURPOSE: This clinical trial is assessing physical and mental status in older patients with
      newly diagnosed acute myeloid leukemia.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Test the feasibility of pre-treatment, bedside assessment of functional and cognitive
           status in older adults with newly diagnosed acute myeloid leukemia (AML).

      Secondary

        -  Obtain preliminary data regarding the predictive value of pre-treatment, bedside
           assessment of functional and cognitive status on overall survival, length of
           hospitalization and early death.

      OUTLINE: This is a prospective study.

      At baseline, patients complete questionnaires including the Vulnerable Elders Survey
      (functional status), the Mini-Mental Status Exam (cognition), and the Center for
      Epidemiologic Studies-Depression. Patients also undergo physical function testing via the
      Short Physical Performance Battery and hand grip strength. Further information parameters are
      obtained by periodic medical chart reviews.

      Patients are followed every 3 months for up to 2 years.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with acute leukemia >= 60 years of age
      
Keywords: depression; cognitive/functional effects; untreated adult acute myeloid leukemia; adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with t(15;17)(q22;q12); adult acute myeloid leukemia with t(16;16)(p13;q22); adult acute myeloid leukemia with t(8;21)(q22;q22)
Clinical Evaluation of Hydrogels vs Silicone Hydrogel Contact Lenses
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The aim of this fitting study is to evaluate the clinical performance of different hydrogel
      and silicone hydrogel contact lenses.
    

Detailed description: 
      This is a 20-subject, double masked, randomized, contra lateral, 2-day non-dispensing fitting
      trial.
    

Intervention name(s): Pair 1 (ocufilcon D / ocufilcon D); Pair 2 (ocufilcon D / enfilcon A); Pair 3 (ocufilcon D / comfilcon A); Pair 4 (methafilcon A / methafilcon A); Pair 5 (methafilcon A / comfilcon A); Pair 6 (omafilcon A / comfilcon A)
Intervention type(s): Device; Device; Device; Device; Device; Device
Intervention description(s): Randomized to contra lateral lens pair 1 (ocufilcon D hydrogel / ocufilcon D hydrogel); Randomized to contra lateral lens pair 2 (ocufilcon D hydrogel / enfilcon A silicone); Randomized to contra lateral lens pair 3 (ocufilcon D hydrogel / comfilcon A silicone); Randomized to contra lateral lens pair 4 (methafilcon A hydrogel sphere / methafilcon A hydrogel asphere); Randomized to contra lateral lens pair 5 (methafilcon A hydrogel / comfilcon A silicone); Randomized to contra lateral lens pair 6 (omafilcon A hydrogel / comfilcon A silicone)
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment