bioihbjkbjnl/mcl2 huggingface dataset:
Mouth Handicap in Systemic Sclerosis
Condition: Scleroderma; Systemic Sclerosis; Mouth Diseases
MeSH terms: Mouth Diseases; Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis
Study type: Interventional

Summary: 
      In this study, it is aimed to investigate the mouth handicap in Systemic Sclerosis.
    

Detailed description: 
      Systemic Sclerosis is an autoimmune connective tissue disease with fibrosis. Although its
      etiology and pathogenesis have not been clearly defined, it has a chronic course. Systemic
      sclerosis is estimated to affect approximately 300,000 people in the United States. Most
      commonly, it affects adults and women.

      Narrowing of the mouth opening and mouth pain are the two most important causes reported by
      adults with systemic sclerosis. In patients with systemic sclerosis, orofacial findings such
      as microstomy or reduced mouth opening are frequently seen. Microstomy is defined as the
      distance between the incisors is less than 40 millimeters. In severe microstomy, this
      distance is less than 30 millimeters. It is approximately 33 millimeters in adults with
      systemic sclerosis. Microstomy in systemic sclerosis mainly results from submucosal collagen
      deposits that contribute to fibrosis in the perioral tissue. Microstomy is seen in 43% to 80%
      of adults with systemic sclerosis.

      When the current literature is examined, Bongi et al. evaluated the effectiveness of
      face-specific programs, which are applied together with general rehabilitation programs in
      patients with systemic sclerosis; they demonstrated that these techniques improve disability,
      health-related quality of life (HRQoL), and facial functionality.

      In this study, it is aimed to investigate the mouth handicap in Systemic Sclerosis.
    

Intervention name(s): Evaluation
Intervention type(s): Other
Intervention description(s): The study will be carried out with the method of filling the evaluation form which is printed on paper with ballpoint pen.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Scleroderma; Systemic sclerosis; Mouth
Safety, Reactogenicity, and Immunogenicity of mRNA-1653 in Healthy Adults
Condition: Human Metapneumovirus and Human Parainfluenza Infection
MeSH terms: Paramyxoviridae Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This clinical study will assess the safety, reactogenicity and immunogenicity of mRNA-1653, a
      combined human metapneumovirus and human parainfluenza virus type 3 vaccine in healthy
      adults.
    


Intervention name(s): mRNA-1653; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Escalating dose levels; Saline
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: mRNA-1653; human metapneumovirus; human parainfluenza vaccine
KP415 Open-Label Safety Study in Children (6-12 Years of Age) With ADHD
Condition: ADHD
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a multicenter, dose-optimized, open-label safety study with KP415 in children
      with Attention-Deficit/Hyperactivity Disorder (ADHD).
    

Detailed description: 
      The study will consist of a Screening Period, a Dose Optimization Phase, and a Treatment
      Phase and a Follow-Up Visit, as follows:

        -  Screening Period: Subjects will undergo a screening period up to 30 days prior to
           entering the Dose Optimization Phase.

        -  Dose Optimization Phase: During the Dose Optimization Phase, subjects will be titrated
           to doses of 20, 30 or 40 mg KP415 based on tolerability and best individual
           dose-response in the opinion of the Investigator.

        -  Treatment Phase: Eligible subjects will receive single daily doses of KP415 for up to
           approximately 360 days (up to approximately 12 months). The dose of KP415 given in the
           Treatment Phase will be the dose of KP415 at the end of the Dose Optimization Phase.
           During the Treatment Phase, the dose of KP415 may be changed based on individual
           tolerability and best dose response (to either 20, 30, or 40 mg KP415 capsules). Safety,
           efficacy and sleep behavior assessments will be performed.

        -  Follow-Up Visit: 3 ±2 days after administration of the last dose of the Treatment Phase,
           subjects will enter a Follow-Up Visit to evaluate safety parameters.
    

Intervention name(s): KP415 oral capsule
Intervention type(s): Drug
Intervention description(s): Once-daily oral dose
Other intervention name(s): Azstarys; SDX/d-MPH
Intervention MeSH terms: Serdexmethylphenidate and dexmethylphenidate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Outcomes of Three Different Percutaneous Revascularization Strategies for the Treatment of Lifestyle Limiting Claudication: A Retrospective Analysis
Condition: Peripheral Artery Disease
MeSH terms: Peripheral Arterial Disease; Intermittent Claudication
Study type: Observational

Summary: 
      To determine the effect of three different percutaneous revascularization strategies (Balloon
      Cryoplasty vs. Stent Placement vs. Atherectomy) in the treatment of lifestyle limiting lower
      extremity claudication
    

Detailed description: 
      Endovascular revascularization of the superficial femoral artery (SFA) has become one of the
      most commonly performed endovascular procedures.The ability to offer the patient an
      alternative to surgical revascularization, limited by significant morbidity and mortality,
      with a same-day outpatient percutaneous procedure underlies the popularity of the
      endovascular approach. Although surgical bypass of the SFA remains the gold standard for
      revascularization, it is associated with significant morbidity and mortality.Comparative data
      between cryoplasty, angioplasty or stenting of the SFA will ultimately be required to provide
      more robust evidence of the efficacy of each mode of therapy.This registry is designed to
      determine the efficacy of three different percutaneous revascularization strategies
      (Cryoplasty vs. Stent Placement vs. Atherectomy) in the treatment of lifestyle limiting lower
      extremity claudication.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        male and female over the age of 18 who have had Three Different Percutaneous
        Revascularization Strategies
      
Biospecimen description: 
      blood
    
Keywords: PAD; Peripheral Artery Disease; PVD; Peripheral Vascular Disease; Leg Blockage; Angioplasty; Stent; Claudication
Capecitabine and Interferon-Alpha in Metastatic Renal Cell Carcinoma Patients With Failure on Interleukin-2 Based Regimens
Condition: Carcinoma, Renal Cell
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to determine preliminary efficacy of capecitabine and
      interferon-alpha in second-line after interleukin-2 based regimens in patients with MRCC
    


Intervention name(s): capecitabine, interferon-alpha
Intervention type(s): Drug
Intervention description(s): Patients who meet inclusion/exclusion criteria will receive combination of study drugs.
Intervention MeSH terms: Interferons; Interferon-alpha; Capecitabine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: kidney cancer, capecitabine, interferon
Pre-SunBeam TEWL AUC
Condition: Atopic Dermatitis
MeSH terms: Dermatitis
Study type: Interventional

Summary: 
      Transepidermal Water Loss (TEWL) measurements are a valuable tool to determine the integrity
      of a person's skin barrier. In patients with skin conditions, like atopic dermatitis, skin
      barrier can be disrupted or weakened, leading to a more severe phenotype and disease
      characteristics. There are several commercially available TEWL measuring devices, including
      the Aquaflux AF200 and the GPSkin Barrier Pro. This study is a pilot study to determine if
      these two devices produce similar readings for TEWL/skin barrier on patients with and without
      atopic dematitis (AD). The research team would like to investigate whether these devices are
      comparable for initial TEWL readings as well as after several rounds of tape strips have been
      collected from the skin. Tape strips are small circular adhesives, much like tape, that
      remove the very outermost layers of skin cells. It will be important to know if both of these
      devices provide correlative values for TEWL once the outermost layers of the skin have been
      removed by tape stripping.
    


Intervention name(s): GPSkin Barrier Pro; Aquaflux AF200
Intervention type(s): Device; Device
Intervention description(s): This study is a pilot study to determine if this device produces similar readings than Aquaflux AF200 for TEWL/skin barrier on patients with and without atopic dematitis (AD).; This study is a pilot study to determine if this device produces similar readings than GPSkin Barrier Pro for TEWL/skin barrier on patients with and without atopic dematitis (AD).
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Transepidermal Water Loss
Delivering an Evidence-Based Lifestyle Intervention Via the Internet: A Randomized Controlled Study
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Hershey Medical Center and the University of Pittsburgh are doing a research study to help
      meet the needs of the adult population at risk for diabetes and heart disease. This study
      will provide a web-based program that aims to help participants to develop healthier eating
      habits, lose weight and become more physically active. The Internet-based materials will
      teach participants about healthy eating and physical activity and will ask them to
      incorporate the information they learn into their daily lives.

      The purpose of this study is to evaluate the effectiveness of online lifestyle change
      programs to promote weight loss, healthy eating and physical activity patterns, in the
      interest of reducing risk for and adverse outcomes of type 2 diabetes (T2D) and
      cardiovascular disease (CVD).
    


Intervention name(s): More-Intensive; Less-Intensive
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The online lifestyle intervention will include elements of a behavioral lifestyle program developed by the Diabetes Prevention Program. The program will assist individual participants with establishing appropriate weight loss goals, implementing dietary recommendations (including analysis of current diet), and defining exercise programs. The program curriculum provides standard information about healthy lifestyle, and behavioral techniques for integrating them into daily living. In each lesson, patients provide feedback about how they interpret the information, and ideas for integrating it into their lives.; The participants will be provided with the information to access the online Diabetes Prevention Program (DPP) intervention materials. Following the original DPP trial, all DPP materials were placed online for the public to access. This group will receive a lifestyle counseling session and tools to facilitate their intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity; Internet
Post Prandial Glucose (PPG) Study of Empagliflozin in Japanese Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the efficacy of empagliflozin administered orally once daily in postprandial
      glucose and 24-hour glycaemic variability compared to placebo given for 4 weeks as
      mono-therapy in Japanese patients with type 2 diabetes mellitus with insufficient glycaemic
      control on no antidiabetic treatment.
    


Intervention name(s): Placebo; Empagliflozin; Placebo; Placebo; Empagliflozin; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Placebo tablet matching Empagliflozin low dose; Empagliflozin low dose; Placebo tablet matching Empagliflozin high dose; Placebo tablet matching Empagliflozin low dose; Empagliflozin high dose tablet once daily; Placebo tablet matching Empagliflozin high dose
Intervention MeSH terms: Empagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Lifestyle Intervention in Overweight Women
Condition: Obesity; Weight Loss; Lifestyle, Sedentary; Physical Activity; Nutritional and Metabolic Disease; Behavior, Health; Cardiovascular Risk Factor
MeSH terms: Overweight; Metabolic Diseases; Weight Loss
Study type: Interventional

Summary: 
      The Exercise and Obesity Health Promotion (PESO) program is a randomized controlled trial
      designed to analyze the effects of a lifestyle intervention in weight management and
      health-related parameters of overweight and obese premenopausal women
    

Detailed description: 
      The PESO (Exercise and Obesity Health Promotion Program) is a program of weight control and
      exercise promotion for overweight and obese premenopausal women, developed by specialists in
      exercise, nutrition, and psychology, under medical supervision. It is a program that promotes
      the autonomy of the participants and the permanent modification of their habits and
      lifestyles, without the use of drugs or any other products, devices, or techniques of
      "slimming".

      Participants in the PESO Program were able to enjoy a regular and multifaceted group program,
      aiming to increase knowledge about permanent body weight control, increased motivation and
      practice of physical activity and exercise, and improved habits food and nutrition. Increases
      in functional mobility, metabolic health, quality of life and the physical and mental
      well-being of the participants are central priorities of this Program.

      The PESO Program was conducted in a university context and was led by teachers and
      researchers from the Faculty of Human Motors and other national and foreign institutions. The
      program is not for commercial purposes, it does not entail financial costs for the
      participants and it is involved in a wide range of scientific research projects, which have
      been recognized by individuals and external entities as relevant and of interest to the
      general population and the community in particular.
    

Intervention name(s): Supervised exercise; Lifestyle intervention from baseline to 4 months; Monthly behavioral sessions
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Two supervised exercise sessions per week from months 4 to 16; Lifestyle intervention from baseline to 4 months; Monthly behavioral sessions consisted of lifestyle interactive sessions will take place monthly and covered and followed contents that were addressed during the first 4 months of the study
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A clinical trial with three-arm
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: obesity; body composition; weight management; cardiovascular and metabolic markers; Behavioral change; Exercise
Exercise Training in Dialysis Patients With Restless Legs Syndrome (RLS)
Condition: Restless Legs Syndrome; End Stage Renal Disease; Hemodialysis; Muscle Cachexia; Sleep Disorders
MeSH terms: Sleep Wake Disorders; Psychomotor Agitation; Restless Legs Syndrome; Kidney Failure, Chronic; Syndrome; Cachexia
Study type: Interventional
Phase: Phase 2

Summary: 
      Uremic etiology Restless legs syndrome (RLS) has been associated with poorer quality of life
      (QoL) compared to RLS-free counterparts mainly due to sleep deprivation factors. Exercise
      training in hemodialysis (HD) patients with RLS has been proven to be a safe approach in
      temporally ameliorating RLS symptoms similarly to the use of pharmacological treatment with
      dopamine agonists. However it not known whether the exercise anabolic stimulus and the
      dopamine agonist treatment could act synergistically for the improvement of physical
      functioning and muscle performance as well as in the amelioration of augmentation symptoms in
      hemodialysis patients with RLS.
    

Detailed description: 
      This is a randomized, placebo-controlled study to evaluate the acute and long term (6 months)
      effect of exercise training in combination with dopamine agonists in quality of life, muscle
      function, sleep quality and metabolism in patients with restless legs syndrome (RLS)
      receiving dialysis therapy.

      Objectives - Aims:

        1. To investigate whether a single bout of intradialytic exercise session could have an
           effect in motor restlessness often seen during hemodialysis session in patients with RLS

        2. To investigate whether a 24 weeks therapy with dopamine agonist or placebo will have an
           effect in sleep quality, functional capacity and metabolic profile of the hemodialysis
           patients with RLS

        3. To examine whether dopamine agonists or placebo and aerobic intradialytic exercise act
           synergistically for the improvement of physical functioning and muscle performance as
           well as it could reduce the signs of augmentation in hemodialysis patients with RLS
    

Intervention name(s): Dopamine Agonist and Exercise
Intervention type(s): Other
Intervention description(s): Dialysis patients will receive dopamine agonist or placebo for 24 weeks following a 24 weeks period of combined treatment with dopamine agonist or placebo and aerobic intradialytic exercise.
Intervention MeSH terms: Dopamine; Dopamine Agonists
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: RLS; Muscle; Dialysis; exercise; dopamine agonist; Sleep
A Clinical Study on Yasmin® vs. Marvelon® in Chinese Women Requiring Contraception
Condition: Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effectiveness in terms of prevention of
      pregnancy and safety of the oral contraceptive Yasmin and Marvelon on cycle control in
      healthy Chinese women
    

Detailed description: 
      The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been
      renamed to Bayer Schering Pharma AG, Germany.

      Bayer Schering Pharma AG, Germany is the sponsor of the trial.
    

Intervention name(s): Yasmin; Marvelon
Intervention type(s): Drug; Drug
Intervention description(s): 30 µg ethinylestradiol, 3mg drospirenone; 30 µg ethinylestradiol, 150 µg desogestrel
Intervention MeSH terms: Desogestrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Endodontic Management of Primary Molars
Condition: Endodontically Treated Teeth
MeSH terms: Tooth, Nonvital
Study type: Interventional

Summary: 
      The purpose of this study was to describe the clinical and radiological outcome of root canal
      treatment with OrthoMTA in primary second molars without successors in which traditional root
      canal treatment with gutta-percha could not be performed.
    

Detailed description: 
      The study included 13 primary mandibular second molars with infected pulp and congenitally
      missing second premolars in which traditional root canal treatment with gutta-percha was
      contraindicated. Pulpectomy was performed in each tooth and the canals were filled with
      OrthoMTA. The clinical and radiological outcomes of the treatment were evaluated at 3, 6, 9,
      and 12 months. Fractal analysis was used to detect changes in the trabecular bone after the
      treatment. Repeated measures analysis of variance test and two independent t-tests were used
      to evaluate the data.
    

Intervention name(s): OrthoMTA (BioMTA)
Intervention type(s): Procedure
Intervention description(s): Primary second molars without successors in which traditional root canal treatment with gutta-percha could not be performed was treated with OrthoMTA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Primary teeth; Root canal filling; Fractal analysis
The Effects of Wild Blueberries on Depressive Symptoms in Young Adults
Condition: Depression; Anxiety; Anhedonia
MeSH terms: Anhedonia; Depression
Study type: Interventional

Summary: 
      This study aims to investigate the effects of a 6-week dietary intervention of 22 g
      freeze-dried whole wild blueberry powder. The outcomes include measures of depression,
      anxiety, anhedonia, cognitive function, and biomarkers of inflammation and oxidative stress.
    

Detailed description: 
      A randomized, double-blind, placebo-controlled, parallel-design study assessing the effects
      of a 6-week intervention of wild blueberry powder in young adults with depressive symptoms. A
      total of 60 participants will be randomly assigned to either 22 g blueberry powder or a
      matched placebo powder consumed daily with water. The severity of depression, anxiety,
      anhedonia, perceived stress, and quality of life will be measured at baseline and 6 weeks
      later. In addition, we will assess changes in cognitive function and transient mood 2 hours
      after consuming a single dose of blueberries.
    

Intervention name(s): Wild blueberry powder; Placebo powder
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 22 g freeze-dried wild blueberry (Vaccinium angustifolium) powder consumed daily with 250 ml water. The powder is sealed in sachets and stored at -24 °C, except when transported. Participants are asked to store the sachets in a freezer until consumption.; 22 g placebo powder matched for macronutrients, color, and flavor consumed daily with 250 ml water. The powder is sealed in sachets and participants are asked to store the sachets in a freezer until consumption.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Blueberry; Anthocyanins
Evaluating the Safety and Tolerability of Brexpiprazole in the Treatment of Adults With Borderline Personality Disorder (BPD)
Condition: Borderline Personality Disorder
MeSH terms: Personality Disorders; Borderline Personality Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study evaluates the safety and tolerability of brexpiprazole in the treatment of adults
      with borderline personality disorder.
    


Intervention name(s): Brexpiprazole
Intervention type(s): Drug
Intervention description(s): Administered as tablets.
Other intervention name(s): Rexulti; OPC-34712
Intervention MeSH terms: Brexpiprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment