bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Tolerability Study of ZP-025 Vaginal Gel for the Treatment of Vaginal Dryness
Condition: Vaginal Dryness
Study type: Interventional

Summary: 
      Evaluation of ZP-025 vaginal gel in terms of efficacy and safety in the treatment of vaginal
      dryness in post-menopausal women with vaginal atrophy in comparison to a group of non-treated
      post-menopausal women with vaginal atrophy after 56 consecutive days and at 4-week follow-up
      only for women applying ZP-025 vaginal gel.
    

Detailed description: 
      Evaluation of ZP-025 vaginal gel in terms of efficacy, tolerability and safety in the
      treatment of vaginal dryness in post-menopausal women with vaginal atrophy in comparison to a
      group of non-treated post-menopausal women with vaginal atrophy for 56 consecutive days.

      This trial will be conducted in compliance with last version of Declaration of Helsinki, with
      GCP as applicable to investigations with IMD, with the applicable regulatory requirements and
      with CRO and Sponsor's SOPs.

      This is a multi-centre, national, randomized, controlled vs. no-treatment, open label study
      The study will take place in 6 centers of menopause at public Hospitals/Universities. An
      ancillary study will be carried on for subjects randomized to ZP-025 group with a follow-up
      visit at 4 weeks
    

Intervention name(s): Vaginal gel, Medical Device Class 2A
Intervention type(s): Device
Intervention description(s): Application twice a day of vaginal gel for 56 consecutive days
Other intervention name(s): Monurelle Biogel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: vaginal dryness; vaginal gel; colostrum; vaginal atrophy
Sleep Quality & Spinal Cord Injury
Condition: Sleep Disorder
MeSH terms: Spinal Cord Injuries; Sleep Wake Disorders
Study type: Observational

Summary: 
      The aim of the study was to evaluate sleep quality in patients with spinal cord injury; to
      investigate the relationship between sleep and spinal cord level, ambulation status,
      spasticity, quality of life, daily living activities, depressive status, neuropathic pain
    

Detailed description: 
      Since survival increases in patients with spinal cord injury, sleep disturbances, which are
      more frequently observed than the general population and have significant impacts on
      mortality, impair long-term quality of life.The aim of the study was to evaluate sleep
      quality in patients with spinal cord injury; to investigate the relationship between sleep
      and spinal cord level, ambulation status, spasticity, quality of life, daily living
      activities, depressive status, neuropathic pain Eighty patients with inpatient rehabilitation
      of spinal cord injury were included in the study.

      Demographic characteristics, duration of spinal cord injury, spinal cord injury level,
      etiology, number of intermittent bladder catheterization (IC), number of night time IC, what
      time they slept, whether they woke up at night, classification of spinal cord injury were
      recorded.

      Ambulation level with Functional Ambulation Classification (FAC), spasticity with Modified
      Ashworth Scale (MAS), depressive symptoms with Beck Depression Index (BDI), quality of life
      with short-form health survey (SF-36), sleep quality The Pittsburgh Sleep Quality Index
      (PSQI), daytime sleepiness Epworth sleepiness scale (ESS), activity of daily living with
      Barthel Index (BI), neuropathic pain were evaluated with the Douleur Neuropathique 4
      questionnaire (DN4) scale.
    

Intervention name(s): Demographic characteristics, duration of spinal cord injury, spinal cord injurylevel, etiology, number of intermittent bladder catheterization (IC), number of night time
Intervention type(s): Other
Intervention description(s): Observational clinical study
Other intervention name(s): Modified Ashworth Scale, Beck Depression Index,Pittsburgh Sleep Quality Index, Epworth sleepiness scale, Barthel Index ,Douleur Neuropathique 4 questionnaire
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with spinal cord injury hospitalized in our hospital
      
Keywords: Sleep quality
TMC 125 Blood Levels Study
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to look at whether changing directly from one medication for HIV
      (efavirenz) to a new medication for HIV (TMC125) has any effect on the levels of TMC125 in
      the blood, compared to when TMC125 is taken without efavirenz having been taken immediately
      beforehand.

      The study aims to help the investigators understand whether it is safe to change directly
      from efavirenz to TMC125 (with no gap between the treatments) in patients who need these
      treatments.

      The study will investigate the blood levels of TMC125 when it is taken both once and twice a
      day.
    

Detailed description: 
      Pharmacokinetic parameters of TMC125 will be evaluated when TMC125 is given without and with
      a 14-day efavirenz intake preceding period in order to evaluate the risk of achieving sub
      therapeutic concentrations of TMC125 when switching straight from efavirenz containing
      regimens

      Safety and tolerability of medications will also be assessed by questions, physical
      examination and laboratory parameters. These will be performed at regular intervals during
      the drug study.
    

Intervention name(s): TMC125 once daily; TMC125 twice daily
Intervention type(s): Drug; Drug
Intervention description(s): Group 1 (n =12): subjects will receive TMC125 400 mg once daily for 14 days followed by 14 days of washout followed by efavirenz 600 mg once daily for 14 days followed by 14 days of TMC125 400 mg once daily; Group 2 (n = 12): TMC125 200 mg twice daily for 14 days followed by 14 days of washout followed by efavirenz 600 mg once daily for 14 days followed by 14 days of TMC125 200 mg twice daily
Intervention MeSH terms: Etravirine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Pharmacokinetic; TMC125; Healthy volunteers; Efavarinz
Music as an Intervention to Improve Hemodynamic Tolerability of Ketamine in Depression
Condition: Depressive Disorder, Treatment-Resistant; Depressive Disorder, Major; Unipolar Depression; Depression, Bipolar
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant; Bipolar Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to assess the impact of music on patients receiving a course of
      intravenous (IV) ketamine for treatment-resistant depression (TRD), both unipolar and
      bipolar. The primary outcome is changes in in systolic blood pressure throughout each
      40-minute infusion. Secondary outcomes include repeated measures of mood, anxiety,
      suicidality, and psychological/physical pain. Aspects of the treatment experience, with and
      without music, will also be explored.
    

Detailed description: 
      Depression is the first cause of disability worldwide, and approximately 1 in 3 patients will
      fail to respond to current treatments. Intravenous (IV) low-dose ketamine has remarkable
      efficacy in even the most treatment-resistant depression (here defined as failure to at least
      two adequate trials of Level 1-evidence psychiatric medications), inducing remission in
      25-50%.

      Over 100 randomized clinical trials (RCTs) show that music can mitigate hemodynamic and
      psychological stress caused by even highly invasive medical procedures. Though never studied,
      music may similarly improve ketamine tolerability.

      In this randomized, single-blind (assessors will not know whether participants receive music
      or not) single-center trial, 20 participants with TRD will receive 1) curated music or 2) no
      music during their course of 6 IV ketamine treatments (0.50mg/kg bodyweight) over 4 weeks.
      The primary aim is to compare changes in systolic blood pressure from the beginning to the
      end (40 minutes, peak plasma concentration) of each infusion between groups.
    

Intervention name(s): Music
Intervention type(s): Other
Intervention description(s): Music will be provided via headphones during all 6 ketamine treatments, beginning at the commencement of each infusion and ending 55 minutes later. On the day of each infusion, before the treatment begins, clinicians will discuss music choices with participants in order to select amongst one of several options that have been designed for this purpose (length, genre, intensity, etc.).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Treatment-Resistant Depression; Ketamine; Music; Hemodynamic Changes
Efficacy and Safety Eval of Guanfacine Hydrochloride in Combination With Psychostimulants in Adults (18-65).
Condition: Adult Attention-Deficit Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      This is considered an investigator-initiated clinical research trial, which means that your
      study doctor is researching a particular medication (in this case a medication that is
      currently FDA- approved) for the treatment of AD/HD in individuals ages 6-17. The medication
      is guanfacine hydrochloride.

      The hypothesis is that this medication could be used in adults with Attention
      Deficit/Hyperactivity Disorder who have not received satisfactory results with their current
      stimulant ADHD medication. The study drug is investigational for use in adults.
      Investigational means it has not been approved by the U.S. Food and Drug Administration (FDA)
      for use in adults.
    

Detailed description: 
      The purpose of this study is to determine whether guanfacine hydrochloride used as an adjunct
      therapy (to subjects' current stimulant medication) would bring about a statistically
      significant improvement in AD/HD symptoms.
    

Intervention name(s): Guanfacine Hydrocholride; Guanfacine Hydrocholride
Intervention type(s): Drug; Drug
Intervention description(s): mg Guanfacine Hydrochloride (orally)
mg Guanfacine Hydrochloride (orally)
mg Guanfacine Hydrochloride (orally)
mg Guanfacine Hydrochloride (orally)
mg Guanfacine Hydrochloride (orally)
mg Guanfacine Hydrochloride (orally); mg Guanfacine Hydrochloride (orally)
mg Guanfacine Hydrochloride (orally)
mg Guanfacine Hydrochloride (orally)
mg Guanfacine Hydrochloride (orally)
mg Guanfacine Hydrochloride (orally)
mg Guanfacine Hydrochloride (orally)
Other intervention name(s): Intuniv; Intuniv
Intervention MeSH terms: Guanfacine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Multicenter Extension Trial to Evaluate the Safety of Testosterone Gel
Condition: Adult Male Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter extension trial in adult hypogonadal males. The purpose of this study
      is to evaluate the safety of testosterone gel delivered using an applicator over an extended
      period of time.
    


Intervention name(s): Testosterone Gel (FE 999093)
Intervention type(s): Drug
Intervention MeSH terms: Testosterone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of One Week Self-management Program in Patients With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The purpose of this study is to explore the effect of one week inpatient self-management
      program (SMP) in patients with fibromyalgia. The SMP is delivered as group
      education/activities by allied health professionals.
    

Detailed description: 
      This study will determine if one week inpatient SMP can reduce FM symptoms and increase
      patients self-efficacy, health status, quality of life and being active health consumers.

      The one-week SMP is designed to help people manage their rheumatic disease and challenges in
      daily life. The program has the same core concepts as outpatient programmes and comprises
      information, discussions on how to cope with the disease and daily life, cognitive management
      skills, exercise, engagement in self-care and interactions with healthcare professionals.
      During the program, the inpatient education unit takes up to 16 patients and 5 relatives per
      week within one diagnostic group. Each educational session lasts for 1.5-2.5 hours and the
      physical activity sessions for 0.5-1 hour. In the evening group sessions, the patients are
      divided into small groups of approximately five participants. They talk together for one hour
      under leadership of one health professional who is educated in coaching. The focus is on
      coping with the disease and daily life.

      For the intervention group there will be a one year follow up study.
    

Intervention name(s): Self-management program
Intervention type(s): Behavioral
Intervention description(s): Participants will receive a one week inpatient self-management program
Other intervention name(s): Patient education
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Self-management; Self-efficacy; Coping; Health consumer; Patient education; Health related quality of life
Transcriptomic Profile of Adipose Tissue Following n-3 Polyunsaturated Fatty Acid (PUFA) Supplementation
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome
Study type: Interventional

Summary: 
      Adipose tissue is a central organ involved in mediating metabolic health, and so the
      investigation of treatments which improve adipose tissue function is warranted. LC n-3
      polyunsaturated fatty acid (PUFA) have been shown to exert positive effects on adipose tissue
      gene expression in previous studies. However this has not been investigated in women with
      polycystic ovary syndrome (PCOS), a population shown to display a degree of adipose tissue
      dysfunction. The aim of this study was to determine the impact of LC n-3 PUFA supplementation
      on gene expression profiles of women with PCOS.
    


Intervention name(s): LC n-3 PUFA (fish oil) Supplement
Intervention type(s): Dietary Supplement
Intervention description(s): 4 x 1g LC n-3 PUFA (fish oil)supplement containing 1.9g EPA and DHA given daily for 6 weeks
Other intervention name(s): LC n-3 PUFA (fish oil); Placebo (PL); Wash-out (WO)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PCOS
Effectiveness of Sulfamethoxazole-trimethoprim in the Treatment of Chronic Otitis Media
Condition: Chronic Otitis Media
MeSH terms: Otitis; Otitis Media
Study type: Interventional

Summary: 
      Chronic suppurative otitis media is one of the most common chronic infections in children
      worldwide. Symptoms include otorrhea, otalgia and hearing loss. In many countries, it is
      treated primarily with antibiotics; in other countries such as the Netherlands a surgical
      approach, such as a tonsillectomy, adenoidectomy, placement or removal of tympanostomy tubes
      or a tympanomastoidectomy is preferred. There is however, no agreement on the management of
      this disease.

      The purpose of this study is to determine the effectiveness of treatment with
      sulfamethoxazole-trimethoprim for 6-12 weeks in children suffering from chronic otitis media
      and otorrhea.
    

Detailed description: 
      Chronic suppurative otitis media is one of the most common chronic infections in children
      worldwide. Symptoms include otorrhea, otalgia and hearing loss. In many countries it is
      treated primarily with antibiotics; in other countries such as the Netherlands a surgical
      approach, such as a tonsillectomy, adenoidectomy, placement or removal of tympanostomy tubes
      or a tympanomastoidectomy is preferred. There is however, no agreement on the management of
      this disease.

      Co-trimoxazole is an inexpensive antibiotic and tolerated well by children, also when long
      treatment regimens or prophylaxis is necessary. A previously performed retrospective study of
      48 children who were referred to the pediatric department of otorhinolaryngology in the UMC
      Utrecht because of "therapeutic resistant" otorrhea showed promising results; after 3 months
      follow-up, 52% of the patients were otorrhea free, 25% had otorrhea incidentally and 23%
      showed no signs of improvement. Therefore, the treatment of chronic otitis media with
      sulfamethoxazole-trimethoprim for a minimum of six weeks is promising and might be a good
      alternative to surgical treatment.

      The purpose of this study is to determine the effectiveness of treatment with
      sulfamethoxazole-trimethoprim during 6-12 weeks in children with chronic otitis media and
      otorrhea for more than 12 weeks.
    

Intervention name(s): Sulfamethoxazole-trimethoprim; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 18 mg/kg, two times a day
Intervention MeSH terms: Trimethoprim; Trimethoprim, Sulfamethoxazole Drug Combination; Sulfamethoxazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Immunogenicity and Safety of the Concomitant Administration of a Tdap Vaccine and Meningococcal ACWY Conjugate Vaccine in Healthy Subjects Aged 11-25 Years
Condition: Meningococcal Disease; Meningococcal Meningitis
MeSH terms: Meningococcal Infections; Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 3

Summary: 
      Immunogenicity and Safety of the Concomitant Administration of a Tdap Vaccine and
      Meningococcal ACWY Conjugate Vaccine in Healthy Subjects Aged 11-25 Years
    


Intervention name(s): Meningococcal ACWY conjugate vaccine (MenACWY-CRM); Combined tetanus, reduced diphtheria and acellular pertussis vaccine (Tdap); saline placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 4.5 mg sodium chloride per 0.5 ml dose
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Meningitis; healthy subject; vaccine
A Comparative Bioavailability and Pharmacokinetic Study of TNX-102 2.4 mg and Cyclobenzaprine 5 mg Tablets in Healthy Adults.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The trial is designed to assess the safety and tolerability of TNX-102 2.4 mg and to compare
      the bio-availability of TNX-102 2.4 mg and cyclobenzaprine 5 mg tablets under fasting or fed
      conditions.
    

Detailed description: 
      Single-center, randomized, open-label, single-dose, three-way-crossover trial is designed to
      assess the safety and tolerability of TNX-102 2.4 mg (a dose based on the results of a
      previous Phase 2a, proof-of-concept study - VPI-CY-0001.1) and to compare the rate and extent
      of absorption of TNX-102 2.4 mg and cyclobenzaprine 5 mg tablets under fasting or fed
      conditions.
    

Intervention name(s): Treatment A; Treatment B; Treatment C
Intervention type(s): Drug; Drug; Drug
Intervention description(s): TNX-102 2.4 mg - 1 gelcap once under fasting conditions.; Cyclobenzaprine 5 mg, 1 tablet once under fasting conditions; TNX-102 2.4 mg, 1 gelcap once given under fed conditions.
Other intervention name(s): cyclobenzaprine HCl; cyclobenzaprine HCl; cyclobenzaprine HCl
Intervention MeSH terms: Amitriptyline; Cyclobenzaprine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Impact of AbbVie Care Patient Support Program on Clinical, Health Economic and Patient Reported Outcomes, in Crohn's Disease, Ulcerative Colitis, Rheumatoid Arthritis, Psoriatic Arthritis, Psoriasis and Axial Spondyloarthritis, in the Portuguese National Health Service
Condition: Crohn's Disease; Ulcerative Colitis (UC); Rheumatoid Arthritis (RA); Psoriatic Arthritis; Psoriasis; Ankylosing Spondylitis (AS); Non-radiographic Axial Spondyloarthritis
MeSH terms: Spondylitis; Arthritis; Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylarthritis; Spondylitis, Ankylosing; Axial Spondyloarthritis; Non-Radiographic Axial Spondyloarthritis; Crohn Disease; Colitis; Colitis, Ulcerative; Psoriasis; Ulcer
Study type: Observational

Summary: 
      This study aims to evaluate the impact of AbbVie Care 2.0 on adalimumab's compliance, patient
      reported outcomes and utilization of health resources over 12 months.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants receiving adalimumab in routine clinical practice in Portugal
      
Keywords: Adalimumab; Humira®; AbbVie patient care support program; Psoriasis; Axial Spondyloarthritis; Rheumatoid Arthritis; Ulcerative Colitis
Safety, Tolerability and Pharmacokinetics of BIBW 2948 BS for HandiHaler® in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate safety, tolerability, and pharmacokinetics of BIBW 2948 BS after repeated
      dosing
    


Intervention name(s): Low dose of BIBW 2948 BS for oral inhalation; Medium dose of BIBW 2948 BS for oral inhalation; High dose of BIBW 2948 BS for oral inhalation; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Gemcitabine and Docetaxel With Bevacizumab in Selected Sarcoma Subtypes
Condition: Sarcoma; Leiomyosarcoma; Malignant Fibrous; Histiocytoma; Angiosarcoma
MeSH terms: Sarcoma; Leiomyosarcoma; Hemangiosarcoma; Histiocytoma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test whether an experimental drug called bevacizumab given
      together with gemcitabine and docetaxel, a standard chemotherapy regimen for sarcoma, can
      help sarcoma patients. This trial will examine what effects, good and/or bad the combination
      of gemcitabine, docetaxel and bevacizumab has on sarcoma.
    


Intervention name(s): gemcitabine; docetaxel; bevacizumab
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Bevacizumab; Gemcitabine; Docetaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bevacizumab (avastin); Gemcitabine; Taxotere (docetaxel); 09-015; Soft tissue