bioihbjkbjnl/mcl2 huggingface dataset:
A Multi Center Study to Validate a Condition-specific Measure of Sexual Health in Women With Pelvic Floor Disorders
Condition: Pelvic Floor Disorders; Sexual Dysfunction; Incontinence; Pelvic Organ Prolapse
MeSH terms: Pelvic Floor Disorders; Prolapse; Pelvic Organ Prolapse
Study type: Observational

Summary: 
      Study Aims:

        1. To validate a new measure of sexual function and activity in women with PFDs;

        2. To establish the responsiveness to change of the new measure.

      The investigators hypothesis is that the investigators can create a new questionnaire that
      accurately measures sexual health in women with pelvic floor disorders that improves on the
      already published questionnaires.
    

Detailed description: 
      600 women presenting for care to urogynecology clinics in the United States and England will
      be recruited to participate. They will give data regarding their physical exam, including
      measurements by the Pelvic Organ Prolapse Quantification exam and medical and surgical
      history. In addition, they will complete validated questionnaires including the Incontinence
      Severity Index, the Pelvic Floor Distress Inventory (short form) and question # 35 from the
      Epidemiology of Prolapse and Incontinence Questionnaire. All women will also complete two
      sexual health questionnaires; the Female Sexual Function Index and the Pelvic Organ Prolapse
      Urinary Incontinence Sexual Questionnaire (Revised). Women will receive standard care for
      their pelvic floor disorders. They will then be recontacted to repeat the same set of
      questionnaires to determine the responsiveness of the new measure. Reliability of the
      questionnaire will be measured by having a subset of women complete the questionnaire twice;
      a factor analysis will be performed to determine the underlying factor structure. Responses
      to the other QOL measures will be compared to those to the new instrument to establish
      validity.
    

Intervention name(s): Survey
Intervention type(s): Other
Intervention description(s): This is a study to develop a survey for sexual health in women with pelvic floor dysfunction
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Goal to enroll approximately 800 women so that 600 surveys are available for evaluation of
        the sexual health of women with pelvic floor disorders presenting for urogynecological care
        in the United States or England
      
Biospecimen description: 
      No Biospecimens are to be retained.
    
Keywords: Pelvic Floor Disorders; Sexual Function; Incontinence; Pelvic Organ Prolapse
A Safety and Pharmacokinetic Study Between HLX02 and Herceptin®(U.S. and German Sourced) in Healthy Chinese Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Assessment of safety of HLX02 at different doses. Randomised, double-blind, parallel group
      Phase I study to compare PK profiles and to assess the safety and immunogenicity between
      HLX02 and Herceptin® (U.S. and German).
    


Intervention name(s): HLX02; Herceptin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Trastuzumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Tolerability of MK0524A Versus Niacin Extended-Release (0524A-054)
Condition: Hypercholesterolemia; Hyperlipidemia
MeSH terms: Hypercholesterolemia; Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a 16-week clinical trial in lipid clinic patients for whom niacin therapy is
      appropriate to evaluate the tolerability of MK0524A versus niacin extended-release. There
      will be 6 scheduled clinic visits and 2 treatment groups.
    


Intervention name(s): niacin (+) laropiprant; niacin
Intervention type(s): Drug; Drug
Intervention description(s): Duration of Treatment: 18 Weeks; Duration of Treatment: 18 Weeks
Other intervention name(s): MK0524A
Intervention MeSH terms: Niacin; Niacinamide; Nicotinic Acids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Primary Hypercholesterolemia or Mixed Hyperlipidemia
Therapy of Oral Appliance for Adults Jordanians With Obstructive Sleep Apnea
Condition: Mild Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Introduction: Obstructive Sleep Apnea (OSA) is the most common form of sleep disordered
      breathing. Patients who arrive at the dental office with a diagnosis of OSA are often treated
      with a mandibular advancement device (MAD). A biomimetic oral appliance therapy (BOAT),
      offers an alternative non-surgical method, which can putatively resolve OSA by combined
      maxilla-mandibular correction, and addressing craniofacial deficiencies.

      The aim: To determine whether maxilla-mandibular correction changes induced by BOAT produce a
      more favorable upper airway, which might result in a reduction in the severity of OSA.

      Protocol: Adults who underwent an overnight sleep study and were diagnosed by a sleep
      specialist physician will be potential subjects for the current study. The BQ and EES will be
      recorded pre- and post- BOAT treatment. Subjects with mild to moderate OSA will have 2 months
      follow up visits and a final overnight sleep study to measure apnea-hypopnea index (AHI). The
      subjects will be asked to wear the appliance for 10-12 hours/day and at night. Findings will
      be analyzed statistically using paired t-tests.
    


Intervention name(s): biomimetic oral appliance therapy (BOAT); Standard hospital treatment
Intervention type(s): Device; Device
Intervention description(s): BOAT appliance is designed to correct maxillo-mandibular underdevelopment in both children and adults (Singh and Lipka, 2009). However, adults will only use for this study. Typically, a BOAT appliance consists of 6 patented, anterior 3-D Axial Springs™, a midline actuator (such as omega loops or screws), posterior occlusal rests, and a round labial bow (Figure 1). Patients will be trained on activation of the screw; Use of CPAP and similar methods
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
An Study of Paliperidone Extended-Release Tablets in the Treatment of Methamphetamine Dependence
Condition: Methamphetamine Dependence
Study type: Interventional

Summary: 
      Methamphetamine substance use is common worldwide. No approved pharmacologic treatments for
      methamphetamine dependence exist. paliperidone are Second generation antipsychotics，and have
      effects of blocking dopamine2(D2) and 5-hydroxytryptamine 2A(5-HT) receptors
      neurotransmitters.To determine whether mirtazapine would reduce methamphetamine use among
      methamphetamine addicts.
    

Detailed description: 
      Methods:A Multiple-Center, Randomized, Double-Blind.
    

Intervention name(s): Paliperidone; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Paliperidone group,3mg/pill,3mg/day forced titration method,last 84 days; placebo group,3mg/pill,3mg/day forced titration method,last 84 days
Other intervention name(s): Paliperidone Extended-Release Tablets; Invega
Intervention MeSH terms: Paliperidone Palmitate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Methamphetamine; paliperidone
Safety, Tolerability and Pharmacokinetic Profile of SYL1801 Eye Drops
Condition: Safety, Tolerability and Pharmacokinetic Profile in Healthy Volunteers; Choroidal Neovascularization
MeSH terms: Choroidal Neovascularization; Neovascularization, Pathologic
Study type: Interventional
Phase: Phase 1

Summary: 
      Study of the safety, tolerability and pharmacokinetic profile of different doses of SYL1801
      eye drops in healthy volunteers.
    


Intervention name(s): SYL18001 sodium Low dose q.d; SYL18001 sodium Middle dose q.d; SYL18001 sodium High dose q.d; SYL18001 sodium High dose b.i.d
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1 drop in the randomized eye once daily; 1 drop in the randomized eye once daily; 1 drop in the randomized eye once daily; 1 drop in the randomized eye twice daily
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Interventional, observer-masked, parallel groups, time-lagged trial to study safety, tolerability and PK of SYL1801 sodium in healthy volunteers.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Oligonucleotide; siRNA (Small Interfering Ribonucleic Acid); Eye Drops; wet AMD (Age-related Macular Degeneration)
A Study To Evaluate The Safety And Therapeutic Equivalence of Tazarotene Foam 0.1% in Subjects With Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the safety and therapeutic equivalence of a generic
      tazarotene foam 0.1% and the reference listed Fabior™ (tazarotene foam, 0.1%) in the
      treatment of acne vulgaris.
    

Detailed description: 
      Although topical retinoids have been individually used to successfully treat acne vulgaris,
      Fabior™ (Tazarotene) Foam, 0.1% is a safe and effective topical therapy used for the
      treatment of acne vulgaris. Actavis has developed a generic formulation of Tazarotene Foam,
      0.1%, and the current study is designed to evaluate the safety and efficacy of this
      formulation.
    

Intervention name(s): Tazarotene (Fabior™); Tazarotene (Actavis); Vehicle foam
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Nicotinic Acids; Tazarotene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Compare the Level of Elafibranor in Blood After Repeat Administration in Japanese and Non-Asian Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is intended to measure the blood levels of Elafibranor and one of its metabolites
      in Japanese and non-Asian Healthy Participants, to be able to compare how the body absorbs,
      distributes, and eliminates Elafibranor after Repeat Administration, in order to support
      inclusion of Japanese patients in the planned clinical studies with elafibranor.
    


Intervention name(s): Elafibranor
Intervention type(s): Drug
Intervention description(s): Oral Tablet
Other intervention name(s): GFT505
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Pharmacokinetics; Elafibranor
Effectiveness of Photo-biomodulation in the Treatment of Chemotherapy Induced Mucositis
Condition: Mucositis
MeSH terms: Mucositis
Study type: Interventional

Summary: 
      The aim of the current study was to study the effect of diode laser in the treatment of
      chemotherapy induced mucositis in young patients suffering from leukemia
    


Intervention name(s): Simpler diode laser; Conventional symptomatic treatment
Intervention type(s): Device; Drug
Intervention description(s): Non-contacting irradiation for 30 seconds on three intraoral sites repeated four times; Conventional treatment using oracure, BBC spray, miconaz three times daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: mucositis - leukemia - chemotherapy
The Efficacy and Safety of Dapoxetine/Sildenafil Combination Therapy
Condition: Premature Ejaculation; Erectile Dysfunction
MeSH terms: Premature Birth; Erectile Dysfunction; Premature Ejaculation
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of Dapoxetine/Sildenafil
      30/50 mg film-coated tablet in the treatment of men with premature ejaculation and erectile
      dysfunction.
    

Detailed description: 
      During 4-weeks treatment period, patients will take one Dapoxetine/Sildenafil 30/50 mg film
      coated tablet 1-3 hours before sexual intercourse.

      Study drug should not be used more than 1 tablet every 24 hours during the treatment.
    

Intervention name(s): Dapoxetine/Sildenafil 30/50 mg film coated tablet
Intervention type(s): Drug
Intervention description(s): 1 tablet before sexual intercourse
Other intervention name(s): Dapoxil
Intervention MeSH terms: Sildenafil Citrate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Premature Ejaculation; Erectile Dysfunction; DAP-SPEED; Dapoxetine; Sildenafil
Study on Colonic Fermentation in Chronic Kidney Disease Patients
Condition: Renal Insufficiency, Chronic
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency
Study type: Observational

Summary: 
      Chronic kidney disease is associated with the accumulation of various metabolites, i.e.,
      uremic retention solutes. Evidence is mounting that the colonic microbiome contributes
      substantially to these uremic retention solutes. Indoxyl sulfate and p-cresyl sulfate are
      among the most extensively studied gut microbial metabolites, and are associated with
      cardiovascular disease, chronic kidney disease progression and overall mortality. Indirect
      findings suggest that chronic kidney disease influences the colonic microbial metabolism with
      higher p-cresyl sulfate urinary excretion rates at more advanced renal disease. Therefore,
      this study aims to elucidate the influence of renal dysfunction on microbial metabolism and
      to test the hypothesis that chronic kidney disease patients carry a different fecal
      metabolite profile.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients treated with renal replacement therapy, i.e. hemo- or peritoneal dialysis for more
        than 3 months
      
Biospecimen description: 
      Fecal sample, serum
A Pilot Study for the Determination of Allergenicity of Cat Dander Samples Obtained by Different Methods
Condition: Cat Dander Allergy
Study type: Interventional

Summary: 
      Measurement of skin reactivity of cat dander samples obtained by different methods.

      Subjects will be assessed for the study by of a conventional skin prick test with a positive
      (histamine), a positive (standardized cat dander extract) and a negative allergen control (a
      diluent) if they fulfil all other in- and exclusion criteria, too.

      A screening prick test will be performed in order to confirm positivity (cat dander allergy).

      A scratch test will be performed in participants after a positive screening prick test, in
      order to measure skin reactivity to cat dander, originating of three different body areas of
      the cat. For this purpose, a small amount of cat fur in solution with distilled water will be
      placed onto the volar aspect of both forearms after the skin has been scratched with a
      scratch lancet. The distilled water in which the cat hair was solved before will serve as
      negative control.

      This procedure will be repeated with fur of the three different areas of the cat, always
      using triplicates (nine samples per cat).

      From each of the 20 cats, nine samples will be tested on 20 subjects (one cat/subject).
    


Intervention name(s): Cat fur scratch test
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Pharmacologic Study of Oseltamivir in Healthy Volunteers
Condition: Avian Influenza A Virus
MeSH terms: Influenza in Birds
Study type: Interventional
Phase: Phase 1

Summary: 
      "Pharmacologic Study of Oseltamivir in Healthy Volunteers" is a Phase I study in which 8 to
      32 adult healthy Thai volunteers will be randomized to one of four drug doses and regimens
      within each of 4 visits. The study is being conducted at the Bangkok Hospital of Tropical
      Diseases Research Unit, Faculty of Tropical Medicine, and commenced enrolling healthy
      volunteers on 23 November 2006. The duration of the study is expected to be approximately
      four months. The goals of this study are to assess the use of loading dose oseltamivir and
      the concomitant use of probenecid and to characterize the pharmacokinetic properties of
      oseltamivir in Thai subjects.
    


Intervention name(s): oseltamivir; probenecid
Intervention type(s): Drug; Drug
Intervention MeSH terms: Oseltamivir; Probenecid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: oseltamivir; pharmacokinetics; probenecid; avian influenza
Safety Study of the Potential Inhibitory Effects of Ciclesonide Nasal Aerosol on the Hypothalamic-Pituitary-Adrenal Axis in Subjects 6-11 Years With Perennial Allergic Rhinitis
Condition: Perennial Allergic Rhinitis; PAR
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, safety
      study of the effects of ciclesonide nasal aerosol (74 mcg) on the HPA axis when administered
      once daily to male and premenarchal female subjects 6 to 11 years of age with a diagnosis of
      PAR.
    

Detailed description: 
      This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, safety
      study of the effects of ciclesonide nasal aerosol (74 mcg) on the HPA axis when administered
      once daily to male and premenarchal female subjects 6 to 11 years of age with a diagnosis of
      PAR.

      The study requires that subjects be domiciled during two 24- to 36-hour time periods for
      sample collection for serum and urinary free cortisol measurements, as well as PK evaluations
      (single [predose] time point during the first domiciled period, and 24-hour sampling during
      the second domiciled period).
    

Intervention name(s): ciclesonide nasal aerosol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ciclesonide nasal aerosol (74 mcg); Placebo
Intervention MeSH terms: Ciclesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Perennial Allergic Rhinitis; PAR
Soy, Bone and Health in College Females
Condition: Osteoporosis; Obesity
MeSH terms: Osteoporosis
Study type: Interventional

Summary: 
      This is a 16-week intervention to determine the efficacy of an isoflavone-rich soy based meal
      supplement to improve bone health and prevent weight and fat gain in 18-19 year old college
      females. The primary hypothesis is that participants who receive soy will have favorable
      changes in blood markers of bone and less weight and fat gain. The soy is provided by
      Physicians Pharmaceuticals, Inc. (Revival Doctor-formulated soy protein).
    

Detailed description: 
      The proposed study will be a 16-week randomized, double-blind, placebo-controlled trial
      designed to test whether a daily isoflavone-rich, soy-based meal replacement Revival Soy
      shake promotes favorables changes in bone biomarkers and attenuates weight gain in female
      college students. First-year college females were selected because of the potential for
      significant weight gain during their freshman year. The study will have a parallel design
      with two groups: the soy treatment group (SOY; n = 60) and a casein-based control (CON; n =
      60). Exclusion criteria include significant weight loss or gain in the past 3 months,
      vegetarians and heavy soy food consumers, National Collegiate Athletic Association Division I
      athletes, women with eating disorders, present illnesses, chronic disease, and those taking
      medications or herbal supplements known to affect body weight, body fat or bone. Participants
      will be stratified based on BMI (18.0-24.9; 25-29.9; ≥30.0) and randomized to either SOY or
      CON groups.

      Female college freshmen enrolled at the University of Georgia will be recruited in the fall
      of 2005. The soy-based meal replacements will contain 20 g soy protein and 161.2 mg
      isoflavones, 220-240 kcal, 31-36 g total carbohydrates, 0-2 g dietary fiber, 500 mg calcium,
      and 2.0-2.5 g total fat per serving. The control shake will have 20 g casein substituted for
      soy protein, and will be otherwise identical to the soy shakes. The shakes will be available
      in two flavors: chocolate and vanilla.
    

Intervention name(s): Soy Protein Dietary Supplement; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The soy-based meal replacements will contain 20 g soy protein and 161.2 mg isoflavones, 220-240 kcal, 31-36 g total carbohydrates, 0-2 g dietary fiber, 500 mg calcium, and 2.0-2.5 g total fat per serving.; The control shake will have 20 g casein substituted for soy protein, and will be otherwise identical to the soy shakes. The shakes will be available in two flavors: chocolate and vanilla.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Challenges Faced By Neurophysiotherapist While Consultation Through Tele-rehabilitation
Condition: Stroke, Parkinson' s Disease, Neurological Impairments, Tele-rehabilitation
MeSH terms: Parkinson Disease
Study type: Observational [Patient Registry]

Summary: 
      Being the most important stakeholder of such a vulnerable population, the neuro
      physiotherapist faced a lot of difficulties while consulting and assessing patients with
      neurological impairments. Up to our knowledge and search history, this is the first-ever
      study conducted by us which list out the challenges faced by neuro physiotherapist while
      teleconsultation mode among Indian population.
    

Detailed description: 
      During the ongoing Covid-19 pandemic many Neurophysiotherapist opted for telerehabilitation
      to provide rehabilitation to the patients. This study aims to find out challenges faced by
      Neurophysiotherapist (NeuroPT) for consultation through telerehabilitation within Maharashtra
      provenance. A total of 103 NeuroPT within Maharashtra provenance were contacted through this
      online survey. A brief, structured and validated questionnaire was constructed as there is no
      gold standard questionnaire developed to obtain responses from the neuro physiotherapists
      opting for telerehabilitation mode for their consultations with their clients. The
      questionnaire was sent by What's app and email to gather basic information to describe the
      various challenges in consultation through telerehabilitation.
    

Intervention name(s): Opinions about tele-rehabilitation for consulting a clients with neurological impairments
Intervention type(s): Other
Intervention description(s): Opinions about telerehabilitation for consultation purpose
Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Neurophysiotherapist practicing within Maharashtra provenance