bioihbjkbjnl/mcl2 huggingface dataset:
The CO2RE® System for Vulvar Lichen Sclerosus
Condition: Vulvar Lichen Sclerosus
MeSH terms: Vulvar Lichen Sclerosus; Lichen Sclerosus et Atrophicus
Study type: Interventional

Summary: 
      Subjects with vulvar lichen sclerosus (VLS) will undergo fractional carbon dioxide (CO2)
      laser treatment to the vulvar area. Subjects will be evaluated for changes in clinical signs
      and architectural changes associated with VLS at designated follow-ups to 1-year post
      treatment series.
    

Detailed description: 
      This study is a prospective, non-randomized, single-group assignment, interventional clinical
      trial. Female subjects with vulvar lichen sclerosus (VLS) supported by histologic findings on
      biopsy and/or clinical signs on physical examination and recalcitrant to mid- to high-potency
      steroid therapy, will undergo up to 5 monthly treatments to the vulva with a fractional CO2
      laser.

      Investigators will assess clinical signs and architectural changes associated with VLS.
      Baseline measurements will be compared to follow-up at 6 weeks, 3 months, 6 months and 12
      months after the final treatment.

      Subjects will self report sexual function using a validated FSFI Questionnaire at baseline
      and at the 3- and 6-month follow-ups.
    

Intervention name(s): The CO2RE® System
Intervention type(s): Device
Intervention description(s): The CO2RE® system is a fractional CO2 laser that is FDA-cleared under a 510(k) K181523 for laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN) for the treatment of leukoplakia (vulvar dystrophies).
Intervention model: Single Group Assignment
Intervention model description: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: vulvar dystrophy; vulvar atrophy; persistent itching; leukoplakia; hyperkeratosis; sexual function
Study of Photodynamic Therapy (PDT) in Patients With Central Serous Chorioretinopathy (CSC)
Condition: Central Serous Chorioretinopathy
MeSH terms: Central Serous Chorioretinopathy
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the safety and efficacy of PDT at 30% verteporfin
      dose in the treatment of CSC.
    


Intervention name(s): PDT
Intervention type(s): Procedure
Intervention description(s): 30% or 50% verteporfin dose PDT was given to patients with CSC
Other intervention name(s): photodynamic therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Study on Safety and Preliminary Efficacy of ALA in Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to explore the safety, tolerability, and preliminary efficacy of
      ALA used with photodynamic therapy for the treatment of moderate to severe acne vulgaris.
    


Intervention name(s): ALA 2.5%; ALA 5%; ALA 10%
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Topical treatment for photodynamic therapy, after drug incubation subsequent illumination with red light (72 J/cm2). 4 treatments at an interval of 10 (± 4) days.; Topical treatment for photodynamic therapy, after drug incubation subsequent illumination with red light (72 J/cm2). 4 treatments at an interval of 10 (± 4) days.; Topical treatment for photodynamic therapy, after drug incubation subsequent illumination with red light (72 J/cm2). 4 treatments at an interval of 10 (± 4) days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Optimal Time of Methimazole Discontinuation Before Radio-iodine Therapy in Hyperthyroid Grave's Patients
Condition: Graves Disease
MeSH terms: Graves Disease
Study type: Interventional

Summary: 
      Iodine therapy is the best treatment for graves disease.Most patients receive methimozale
      prior to radio-iodine treatment. This may decrease treatment response to iodine therapy.

      Some physicians advice to discontinue methimazole 3 days before radioiodine therapy and
      others prefer longer off - methimazole period which bothers most patients. This study aimed
      to evaluate optimum time for methimazole discontinuation in graves disease.
    


Intervention name(s): Methimazole; Methimazole; Methimazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Methimazole was stopped 24-48 before radio-iodine therapy; methimazole discontinued 49-72 hours before radioiodine treatment; methimazole discontinued 73-168 hours before radio-iodine treatment
Intervention MeSH terms: Methimazole
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hyperthyroidism; radio-iodine; I-131; methimazole; graves disease
A Prospective Randomised Study of Efficacy, Safety and Costs of Talc Pleurodesis Under Medical Thoracoscopy and Pleurodesis Under Video-assisted Thoracoscopy Surgery for Recurrent Primary Spontaneous Pneumothorax
Condition: Pneumothorax
MeSH terms: Pneumothorax
Study type: Interventional

Summary: 
      Treatment of recurrent primary spontaneous pneumothorax remains controversial and many
      therapeutic options exist. The aim of this study is to compare pleural symphysis by talc
      poudrage during medical thoracoscopy and surgical management combining pleural abrasion and
      blebs or bullae resection for treatment of recurrent primary spontaneous pneumothorax.
    

Detailed description: 
      Treatment of recurrent primary spontaneous pneumothorax remains controversial and many
      therapeutic options exist. What is the best technical option : treatment of the lung and the
      parietal pleura or treatment of the pleura with pleural symphysis ? Talc pleurodesis
      performed during medical thoracoscopy and resection of blebs or bullae associated with
      pleural abrasion during surgical thoracoscopy (or video-assisted thoracic surgery) are the
      most usual methods. These two procedures have never been compared in a prospective trial. The
      aim of this study is to compare pleural symphysis by talc poudrage during medical
      thoracoscopy and surgical management combining pleural abrasion and blebs or bullae resection
      for treatment of recurrent primary spontaneous pneumothorax.
    

Intervention name(s): talc pleurodesis under medical thoracoscopy; pleurodesis under video-assisted thoracoscopy surgery
Intervention type(s): Other; Other
Intervention description(s): talc pleurodesis under medical thoracoscopy for recurrent primary spontaneous pneumothorax; pleurodesis under video-assisted thoracoscopy surgery for recurrent primary spontaneous pneumothorax
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent primary spontaneous pneumothorax
An Exploratory Study Examining The Effects Of Taking GW679769 Once-Daily For 4 Days In Patients With Functional Dyspepsia
Condition: Nonulcer Dyspepsia
MeSH terms: Dyspepsia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study was designed is to examine the idea that GW679769 has an effect on three of the
      pathophysiological disturbances reported in patients with Functional Dyspepsia (FD): impaired
      stomach accommodation to a meal, delayed stomach emptying, and visceral hypersensitivity to
      distension.
    

Detailed description: 
      An exploratory study to investigate the effects of the NK1 antagonist GW679769, 120 mg once
      daily for 4 days, on gastric accommodation, gastric emptying and gastric distension-induced
      perception and discomfort in adult male and female patients with functional dyspepsia, in a
      single-centre, placebo-controlled, double-blind, randomised, two-period crossover study
    

Intervention name(s): GW679769 oral tablets; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 2x GW679769 60mg tablets; Placebo oral tablets to match experimental intervention
Intervention MeSH terms: Casopitant
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Functional Dyspepsia; Barostat; Stomach
Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of COR-001
Condition: Anemia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety,
      pharmacokinetics, and pharmacodynamic effects of multiple doses of COR-001 or placebo
    


Intervention name(s): COR-001; Placebo
Intervention type(s): Drug; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Technology-Enhanced Helping the Noncompliant Child
Condition: Child Externalizing Behavior
Study type: Interventional

Summary: 
      This study aimed to examine if technology could enhance the treatment engagement and outcomes
      of low income parents of 3 to 8 children with externalizing problems.
    

Detailed description: 
      The aim of this pilot study is to determine whether a technology-enhanced version of an
      established behavioral treatment protocol, Helping the Noncompliant Child (HNC; McMahon &
      Forehand), enhances the engagement and treatment outcomes of lower income parents of 3 to 8
      children with externalizing problems in treatment. It is predicted that families in both the
      HNC and technology-enhanced HNC (TE-HNC) programs will evidence significant improvement in
      parenting behavior and child externalizing problems; however, it is predicted that
      parent-child dyads in the TE-HNC program will require fewer sessions, will be more likely to
      be retained in the program, will be more likely to remain engaged in the program (e.g.,
      practicing skills between sessions etc.), and will be more likely to have active involvement
      from their coparenting partners (i.e., other adults and family members who participate in
      childrearing).In turn, it is expected that the TE-HNC program will boost treatment outcomes.
    

Intervention name(s): Helping the Noncompliant Child (HNC); Technology-Enhanced Helping the Noncompliant Child (TE-HNC)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Well-established behavioral parent training program (McMahon & Forehand) for parents of 3 to 8 y.o. children with externalizing problems; Standard HNC program plus technology-enhancements (see description under Arm)
Other intervention name(s): HNC; TE-HNC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parenting; Parent-Child Relations; Child Behavior
GSK1325756 Relative Bioavailability Study in Healthy Elderly Subjects
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      This 2-part study will be carried out on healthy elderly subjects to evaluate relative
      bioavailability of danirixin formulations. Part A will support the selection of the
      formulation and Part B will assess food effect, bioavailability and pharmacokinetic (PK)
      profile of selected formulation from Part A. Danirixin is currently administered with food,
      therefore the investigation of food effect for the selected formulation could potentially
      enable dosing without food. Approximately 16 subjects will be included in Part A and
      approximately 24 subjects will be included in Part B. Both parts will include a screening
      phase, treatment phase with in-between washout period and a follow-up phase.
    


Intervention name(s): Danirixin; Omeprazole
Intervention type(s): Drug; Drug
Intervention description(s): Danirixin is being developed as a potential anti-inflammatory agent for the treatment of chronic obstructive pulmonary disorder (COPD) and other inflammatory diseases and influenza. Danirixin reference (600 mg) or test formulation (475 or 600 mg or 600 mg with 5 percent HPMC) immediate release tablets will be administered by oral route in a cross-over manner.; Omeprazole is used as an antacid. OMP 40 mg delayed-release capsule will be administered by oral route to randomized subjects.
Intervention MeSH terms: Omeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Subjects will receive danirixin reference and test formulations in a cross-over manner.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Danirixin; Healthy; Food effect; Relative Bioavailability; Hydrobromide Salt
Mindfulness Meditation Versus Physical Exercise: Comparing Effects on Stress and Immunocompetence
Condition: Stress; Health Knowledge, Attitudes, Practice
Study type: Interventional

Summary: 
      The objective of this research project is to examine if including mindfulness meditation or
      physical exercise at lunch break improve workers' recovery from work stress. Therefore, 72
      workers included either mindfulness meditation or physical exercise during their lunchbreaks
      for a month in order to find out if these recovery strategies have more favorable outcomes
      than usually spent lunch breaks concerning: a) psychological detachment, b) perceived stress,
      c) general health, d) burnout, e) fatigue, f) quality of sleep, g) cortisol awakening
      response and h) immunocompetence.
    

Detailed description: 
      The investigators conduct an intervention study in a sample of 72 knowledge-workers, who
      engaged in mindfulness meditation or physical activities for five weeks. They performed from
      15 to 30 minutes during their lunch breaks. The investigators randomly assigned participants
      to three experimental conditions: 1) mindfulness meditation, 2) physical activity, 3) control
      group (lunch break as usual). Online questionnaires before and after intervention assessed
      long term changes regarding recovery processes, perceived stress, health, mindfulness and
      burnout. For daily changes, a mobile application was developed to assess changes once per day
      immediately after work. The investigators also collect saliva samples to map cortisol and
      immunoglobulin A excretion across the intervention period. The investigators had two
      follow-up measures one and six months after the intervention.
    

Intervention name(s): Mindfulness meditation; Physical exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Guided mindfulness meditation focused on breath sensations, thoughts and emotions.; Cardio exercise at gym like rowing, eliptical, cycling, or running outside.
Other intervention name(s): Mindfulness based intervention (MBSR); Cardio exercise
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Mindfulness; Physical exercise; Salivary Immunoglobulin A; Recovery strategy from stress
Subjective Social Status and Energy Balance
Condition: Obesity; Social Dominance; Social Behavior; Eating Behavior
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Investigators examined the associations between SSS, energy balance, food intake and changes
      in body composition following a high calorie lunch for 2 weeks.
    

Detailed description: 
      Subjective social status (SSS) is inversely associated with body fatness. The physiological
      and psychological effects of low social status may spur increased energy intake as a strategy
      to buffer against future food scarcity. Investigators' central hypothesis is that females
      with low SSS will not compensate for excess calorie consumption in a single large meal as
      well as individuals with high SSS, and will therefore remain in positive energy balance
      leading to body fat gain in response to daily large meals. Investigators' objective is to
      understand the influence of SSS on eating behavior, weight gain, and energetic compensation.
      Investigators conducted a 14-day feeding protocol that consisted of consumption of a
      lunch-time meal that was 60% of participants' estimated 24-hour energy requirements each day
      in female participants between 20-50 years, with a body mass index between 25- 30 kg/m2.
      Free-living food intake was recorded using the Remote Food Photography Method outside of the
      lab on days 1-2 (early), 7-8 (middle), and 12-13 (late), to measure compensation in response
      to the large lunch. 24-Hour energy balance, 24 hour intake and post-lunch energy intake were
      calculated for those days. Investigators measured body composition using Dual energy x ray
      absorptiometry (DXA), weight and resting energy expenditure at the baseline and at the end of
      the 14 days of the intervention.
    

Intervention name(s): Dietary intervention
Intervention type(s): Behavioral
Intervention description(s): For the feeding intervention, participants consumed a meal that contains 60% of their energy daily energy requirement as a lunch time meal for 14 consecutive days under observation except during the weekends. To ensure the participant receives 60% of the daily energy requirement as a lunch meal we added a supplemental shake to the standard 1200 kcal meal.
Intervention model: Single Group Assignment
Intervention model description: A prospective feeding study with convenience sampling
Masking: Single (Participant)
Primary purpose: Other
Keywords: Subjective social status; Obesity; High calorie intake; Energy balance; Eating behavior
Role of the ANS Dysregulation in the Persistence of Fatigue in Rheumatoid Arthritis Patients Treated With Anti-TNF
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid; Fatigue
Study type: Interventional

Summary: 
      Despite the large therapeutic arsenal available since one decade allowing a strong reduction
      of inflammation process, rheumatoid arthritis (RA) patients claimed pain, fatigue, sleep
      problems and other quality of life outcomes. Fatigue reduction during TNF blockers therapy is
      lower than the strong reduction in RA disease activity. Furthermore, RA patients have higher
      prevalence of non-inflammatory pain than general population. Fatigue is a real major problem
      due to 50% of patients considered it as severe.

      This dissociation between disease activity and fatigue level suggests that fatigue is
      multifactorial. No consistent explanations for fatigue are currently available.
    


Intervention name(s): VistaO2
Intervention type(s): Device
Intervention description(s): ANS (sympathetic nervous system) parameters are measured by VistaO2 device in RA patients
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Rheumatoid Arthritis; sympathetic nervous system; SNA; fatigue
Brief Chemoimmunotherapy With R+B+M Followed by R in Elderly Patients Advanced Stage Untreated Follicular Lymphoma
Condition: Follicular Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a prospective, multicenter phase II trial designed to determine efficacy and safety
      of a brief chemoimmunotherapy with the combination of Rituximab + Bendamustine + Mitoxantrone
      in elderly patients with advanced stage Follicular Lymphoma.
    


Intervention name(s): Rituximab, Mitoxantrone, Bendamustine
Intervention type(s): Drug
Intervention description(s): Rituximab will be supplied as 375 mg/sqm for i.v.administration.Mitoxantrone will be supplied as 8 mg/sqm for i.v.administration.Bendamustine will be supplied as 90 mg/sqm for i.v.administration
Intervention MeSH terms: Rituximab; Bendamustine Hydrochloride; Mitoxantrone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Validation of HepaFat-Scan for Noninvasive Measurement of Steatosis in Youth
Condition: Non-alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      The purpose of this study is to see if the HepaFat-Scan (a special sequence of images done in
      a MRI) can accurately detect the amount of fat in the liver.
    

Detailed description: 
      The leading cause of liver disease for both adults and children in the US is nonalcoholic
      fatty liver disease (NAFLD), an obesity-related liver disease closely associated with the
      metabolic syndrome. NAFLD increases the risk of liver disease but also increases risk of type
      II diabetes, cardiovascular disease (CVD) and the metabolic syndrome. Invasive liver biopsy
      has been considered the best diagnostic tool for confirming NAFLD. This study will establish
      magnetic resonance imaging (MRI) / magnetic resonance spectroscopy (MRS) as a quantitative
      noninvasive "virtual biopsy" and benefit the health of children with liver diseases by
      decreasing risk and improving diagnosis. Specifically, in NAFLD, this fat quantification
      protocol will be broadly useful in future research studies, including therapies for NAFLD as
      well as for patient diagnosis and follow-up.
    

Intervention name(s): Magnetic Resonance Imaging (MRI)
Intervention type(s): Procedure
Intervention description(s): A MRI scan which will include magnetic resonance spectroscopy (MRS) of the liver to determine hepatic triglyceride content, a hepafat scan to measure volume fraction of fat in liver tissue, and a MRI for detection of liver fibrosis. The scan will last approximately 15 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: HepaFat-Scan; Liver Disease; Pediatrics
Cognitive-Behavioral Therapy for Adults With ADHD: A Qualitative Study
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      This is a qualitative study of participants who have taken part in a randomized controlled
      trial (RCT) of a new treatment protocol based on cognitive-behavioral therapy for adults with
      attention deficit/hyperactivity disorder predominantly inattentive presentation. The purpose
      of the qualitative study is to explore participant perceptions of taking part in the RCT to
      further develop and improve the new treatment protocol.
    


Intervention name(s): Cognitive-behavioral therapy
Intervention type(s): Behavioral
Intervention description(s): Cognitive and behavioral interventions aimed at increasing behavioral activation, and reducing procrastination and inattentive symptoms.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment