bioihbjkbjnl/mcl2 huggingface dataset:
The Use of a FDA Cleared, Drug-free, Breathing System for Anxiety and Panic Disorders in Children and Teens
Condition: Anxiety; Panic Disorder
MeSH terms: Anxiety Disorders; Panic Disorder
Study type: Interventional

Summary: 
      This study will test the efficiency of the Freespira Breathing System in youth.
    

Detailed description: 
      The Freespira Breathing System (FBS; www.freespira.com) developed by Palo Alto Health
      Sciences, Inc, is a portable home device , and has been employed in breathing biofeedback in
      adults with panic disorder (PD). The FBS has now received FDA clearance for the treatment of
      PD adults and is currently commercially available and more than 150 therapist have provided
      the service nationally. However, FBS has not yet been tested for efficacy in a pediatric
      populations. Due to its portability, FBS may pose an advantage for use in younger age groups,
      compared to multiple therapy sessions required for cognitive behavioral therapy (CBT) or
      lower acceptability for long-term medication use for adolescent PD.

      In this pilot intervention study, the efficacy of the FBS system in youth will be tested. In
      children adolescents, PD itself is less common than in adults, but when present, PD is
      commonly associated with and/or preceded by other anxiety conditions, including generalized
      anxiety disorder (GAD), social phobia (SoP) and separation anxiety (SAD). Thus, in children
      and adolescents, the breathing biofeedback intervention for panic, should include other
      anxiety disorders.
    

Intervention name(s): Freespira Breathing System
Intervention type(s): Device
Intervention description(s): Over an 8-week period the efficacy of the FBS system in youth will be tested, with those in the randomized active device group. The control group will not receive the device until completion of the 8 week baseline.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obsessive Compulsive Disorder (OCD); Anxiety; Pediatrics
Comparison of 5% Potassium Hydroxide With 10% Potassium Hydroxide Solution in Treatment of Molluscum Contagiosum
Condition: Molluscum Contagiosum
MeSH terms: Molluscum Contagiosum
Study type: Interventional
Phase: Phase 1

Summary: 
      Molluscum is a virus-related skin infestation which is commonly seen among children.
      Molluscipox virus, the largest human virus, causes it. MC typically manifests as a single or
      multiple dome-shaped, shiny, pearly white papules with a central dimple. In immunocompetent
      individuals, spontaneous resolution usually occurs within 18 months; however, the lesion may
      persist for several years. Asymptomatic lesions are common. It is also linked to a high risk
      of transmission and an increasing prevalence in global populations1-2.

      Patients may receive therapy for social and cosmetic reasons, and also to avoid spreading
      disease to others. Numerous modalities are currently available, including Potassium
      hydroxide, curettage, cryotherapy, disinfected needle pricking, photodynamic therapy, laser,
      salicylic acid, glycolic acid etc3-4.

      Potassium hydroxide (KOH) is a topical treatment for Molluscum contagiosum. Dermatologists
      routinely use potassium hydroxide (KOH) in varying concentrations to identify fungal
      elements. Because it is a strong alkali with keratolytic characteristics, variable
      concentrations given for management of MC. Because it is inexpensive and widely accessible,
      it has the potential to be a useful method for treating for MC in resource-constrained
      countries5-6.

      The purpose of this study is to examine two varied concentrations of Potassium hydroxide
      (5%-KOH vs 10%-KOH) among MC patients in order to determine the most effective KOH
      concentration to manage Molluscum Contagiosum among children.
    


Intervention name(s): potassium hydroxide
Intervention type(s): Drug
Intervention description(s): Potassium hydroxide (KOH) is a topical treatment for Molluscum contagiosum. Dermatologists routinely use potassium hydroxide (KOH) in varying concentrations to identify fungal elements. Because it is a strong alkali with keratolytic characteristics, variable concentrations given for management of MC.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: potassium hydroxide 5% and 10% lotion
A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Administering Multiple Oral Doses of GSK1292263 Alone and With Atorvastatin
Condition: Dyslipidaemias; Dyslipidemias
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 2

Summary: 
      This study investigates the safety, pharmacokinetics and effects of GSK1292263 when taken
      alone or when co-dosed with atorvastatin to subjects with dyslipidemia.
    

Detailed description: 
      This compound has been studied in healthy subjects and subjects with type II diabetes and is
      now being studied in subjects with dyslipidemia. Because many patients with dyslipidemia are
      on statins, it is important to study how GSK1292263 behaves when taken with a potent statin,
      atorvastatin. The cholesterol lowering drug, ezetimibe, is included for comparison.
    

Intervention name(s): 10mg atorvastatin; 80mg atorvastatin; GSK1292263 Placebo; 100mg GSK1292263; 300mg GSK1292263; 800mg GSK1292263; 10mg ezetimibe; Washout
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Other
Intervention description(s): 10mg; 80mg; Placebo; 100mg; 300mg; 800mg; 10mg; No interventions - washout period
Other intervention name(s): Lipitor; Lipitor; Zetia
Intervention MeSH terms: Atorvastatin; Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Pharmacodynamics; Lipids; Dyslipidemia; Safety; GSK1292263; Ezetimibe; Statin; Pharmacokinetics; Tolerability; Atorvastatin
A Safety and Efficacy Trial of a Treat and Extend Protocol Using Ranibizumab With and Without Laser Photocoagulation for Diabetic Macular Edema
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this research study is to determine if a "Treat and Extend" regimen
      (increasing the time between visits when the disease is stable and not getting worse) of
      Ranibizumab 0.3 mg injections inside the eye is safe and effective at treating patients with
      swelling of the retina from diabetes.
    

Detailed description: 
      This research study will compare the visual outcomes between a group of patients who are
      treated with monthly injections of Ranibizumab 0.3 mg and two groups of patients who are
      treated with the "Treat and Extend" regimen. One of the "Treat and Extend" groups will also
      receive laser therapy to determine if this has any additional beneficial effects.
    

Intervention name(s): Ranibizumab 0.3 mg intravitreal injection; Guided Laser Photocoagulation
Intervention type(s): Drug; Device
Other intervention name(s): Ranibizumab; Lucentis; NAVILAS Guided Laser System
Intervention MeSH terms: Ranibizumab
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Antibodies to Digoxin for Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      Subjects suffering from bipolar disorders treated with specific medications will give their
      informed concent and will receive intravenously only one dose of Digoxin antibodies (Fab).
      Their response to this therapy will be measured accordingly.Previous medications will be not
      changed A base line serum Endogenous Digitalis-like Compounds (DLC)levels will be measured
      using a specific laboratory technique and these compounds will be measured at 6 and 24 hours
      after Fab therapy.

      Patients also will be followed using clinical and psychological tests
    

Detailed description: 
      Twenty subjects suffering from bipolar disorders treated with specific medications will give
      their informed concent and will included in the study. All will receive in an open study only
      one intravenously dose of Digoxin antibodies (Fab). Their response to this therapy will be
      measured accordingly.Previous medications will be not changed A base line serum Endogenous
      Digitalis-like Compounds (DLC)levels will be measured using a specific laboratory technique
      and these compounds will be measured at 6 and 24 hours after Fab therapy.

      Patients also will be followed using clinical and psychological tests
    

Intervention name(s): Digibind (Fab)
Intervention type(s): Drug
Intervention description(s): Intravenous Digibind (Digoxin Antibodies-Fab) is delivered only once in 30-45 minutes to patients after receiving the informed concent.
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Digoxin Antibodies; Bipolar Disorder
Safety and Efficacy of Virtual Reality Mindfulness in Patients With Psychosis
Condition: Schizophrenia Spectrum Disorders; Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorders; Psychotic Disorder Not Otherwise Specified
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional

Summary: 
      This study is to evaluate the safety and efficacy of Virtual Reality Mindfulness in Patients
      With Psychosis.
    

Detailed description: 
      This study is randomized, single-blind and parallel group trial to evaluate the safety and
      the efficacy of Virtual Reality Mindfulness in Patients With Psychosis once a week over 8
      weeks treatment period. Both groups can experience the screen coming out of the head-mounted
      display for 30 minutes in a comfortable sitting position.
    

Intervention name(s): Virtual Reality Mindfulness Treatment; Experience relaxing scenery and music
Intervention type(s): Other; Other
Intervention description(s): once a week for 30 minutes, over 8 weeks; once a week for 30 minutes, over 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Virtual Reality Mindfulness
Effect of Probiotics on the Digestibility and Immunity in Infants
Condition: Gastrointestinal Tract Flora Composition
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effect of the probiotic product on the GI tract
      flora composition.
    


Intervention name(s): Biostime probiotics sachet children's formula; Biostime probiotics sachet children's formula（placebo）
Intervention type(s): Drug; Drug
Intervention description(s): Biostime probiotics sachet children's formula,1.5g Oral Single dose; Biostime probiotics sachet children's formula（placebo）,1.5g Oral Single dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Artemisinin With Risperidone for First-Episode and Drug-Naive Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will determine the effectiveness of artemisinin plus risperidone in improving
      symptoms and cognitive disturbances and in Chinese people with schizophrenia. The study
      addresses the Toxoplasma infection hypothesis of schizophrenia.
    

Detailed description: 
      Evidences of high levels of Toxoplasma gondii antibodies in the serum and the cerebrospinal
      fluid (CSF) of individuals with schizophrenia have suggested that this organism might be
      involved in the etiopathogenesis of schizophrenia. The investigators hypothesize that
      antimicrobial therapy by using an add-on agent together with a well-proven neuroleptic may
      have favorable effects on a subgroup of schizophrenic patients.
    

Intervention name(s): Artemisinin; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 400 mg/day; 400mg/day
Other intervention name(s): Qinghaosu
Intervention MeSH terms: Artemisinins; Artemisinin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Schizophrenia; Risperidone; Artemisinin; Toxoplasma; Immune
Change in Biting Force After Botox Injection
Condition: Bruxism
MeSH terms: Bruxism
Study type: Interventional

Summary: 
      Implant rehabilitation is a successful treatment option for edentulous patients. Decreasing
      bone loss around implants is an important target for all implantologists. It has been shown
      that pathological forces, such as bruxism, may in fact result in bone loss and eventual
      implant failure.

      Botilinium Toxin is a material of many clinical uses. Beside its cosmetic applications, it
      has been used in the treatment of masseter muscle hypertrophy.

      Purpose: To investigate the effect of botilinium toxin injection on biting forces, and its
      ultimate effect on peri-implant bone changes.
    


Intervention name(s): Botox Injectable Product
Intervention type(s): Drug
Intervention description(s): Botox is a well known neurotoxin that is derived from the bacterium clostridium botulinium. Its therapeutic applications are variable and well documented, alongside its cosmetic applications. There are seven known serotypes of Botox, from A to G, but only two types; A &B, are available for medical and cosmetic uses.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Effect of Nutritional Intervention on Metabolic Response in Infants
Condition: Infant Development; Glucose, High Blood
Study type: Interventional

Summary: 
      The purpose of this study is to determine the glucose response of complementary feeding
      regimens consisting of two different follow-up formulas (FUFs) and infant cereals (ICs).
    

Detailed description: 
      This is a prospective, randomized, single-blind, controlled, 2-arm parallel group trial in
      infants aged 6 months (26 weeks) at enrollment, who are no longer breastfed, and who are
      ready but have not yet started complementary feeding. They will be fed one of two different
      isocaloric feeding regimens (Experimental [EXPL] or Control [CTRL]) consisting of different
      follow-up formulas (FUFs) and infant cereals (ICs). The main purpose of this study is to
      determine the glucose response of these two different complementary feeding regimens. All
      enrolled infants will participate in the trial for approximately 6 months.
    

Intervention name(s): EXPL feeding regimen; CTRL feeding regimen
Intervention type(s): Other; Other
Intervention description(s): EXPL FUF (lower protein and 100% lactose) + EXPL IC (whole grains and legumes); CTRL FUF (standard protein content and carbohydrate profile) + CTRL IC (refined grains)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Enteric-coated Mycophenolate Sodium (EC-MPS) and Mycophenolate Mofetil (MMF) in Renal Transplant Patients With Gastrointestinal (GI) Intolerance
Condition: Renal Transplantation
Study type: Interventional
Phase: Phase 4

Summary: 
      Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in
      gastrointestinal (GI) complications in some patients. This study will investigate the safety
      and tolerability of converting kidney transplant recipients with gastrointestinal symptoms
      from their current treatment of mycophenolate mofetil (MMF) to treatment with enteric-coated
      mycophenolate sodium (EC-MPS).
    


Intervention name(s): Enteric-coated mycophenolate sodium (EC-MPS); Mycophenolate mofetil; Placebo to mycophenolate sodium; Placebo to mycophenolate mofetil
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Enteric-coated mycophenolate sodium supplied as 180 mg tablets.; Mycophenolate mofetil supplied as 250 mg capsules.; Placebo to mycophenolate sodium matching tablets.; Placebo to mycophenolate mofetil matching capsules.
Other intervention name(s): Myfortic®
Intervention MeSH terms: Mycophenolic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: RenalTransplantation; KidneyTransplantation; MPA; EC-MPS
Effects of Nut Consumption on Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      This study aimed to investigate the effects of nut consumption on metabolic parameters and
      biomarkers related to inflammation, oxidative stress, and endothelial function in Korean
      adults with metabolic syndrome.
    

Detailed description: 
      A randomized, controlled, parallel, dietary intervention study was designed. Subjects with
      metabolic syndrome and body mass index ≥23 kg/m2 were randomized to the Nut group, which were
      supplemented with 30 g of mixed nuts including walnuts, peanuts, and pine nuts for 6 weeks;
      or allocated to the Control group. Metabolic markers were evaluated at baseline and at the
      end of the study.
    

Intervention name(s): Nut group
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: nuts; metabolic syndrome; lipid profile; inflammation; oxidative stress; endothelial function
Neuroelectrical Biomarkers for Alzheimer's Disease Stages
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional

Summary: 
      Recent diagnostic criteria for Alzheimer's disease (AD) recognize an extended spectrum of AD
      stages as part of the disease, including a preclinical stage. This underscores the importance
      of early prognosis of AD when it is still possible to influence the course of the disorder.
      The investigators propose a comprehensive project which will target the data-driven modeling
      of the disease development. This goal will be achieved by creating and validating a battery
      of new sensitive biomarkers for clinical evaluation and prediction of AD in individuals. The
      AD-related brain changes will be assessed by noninvasive functional EEG measured during an
      episodic memory task in subjects at different stages of AD, as well as in healthy controls.
      The novel functional biomarkers will be extracted using a rigorous multistage selection
      procedure involving advanced methods for feature extraction, as well as statistics and
      classification for optimal selection. The ESTIMATE project will serve as a first step in an
      extensive array of research procedures which will enable the early clinical identification of
      Alzheimer's disease in elderly individuals who could then take advantage of preventive
      pharmaceutical therapies.
    


Intervention name(s): EEG
Intervention type(s): Device
Intervention description(s): EEG recorded during a resting condition and during an episodic memory task condition
Other intervention name(s): Electroencephalography; Electrical Geodesics Incorporated
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Alzheimer's disease; Dementia; Prodromal; EEG; ERP; Biomarkers
To Compare the Effect of Inhaled Insulin With Subcutaneously Injected Insulin in Subjects With Type 2 Diabetes Mellitus.
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial was designed to compare meal related inhalation of Technosphere/Insulin to
      subcutaneous regular insulin in patients with type 2 diabetes.
    


Intervention name(s): Technosphere/Insulin
Intervention type(s): Drug
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
China Registration Study in Patients With Skin Infections
Condition: Skin Diseases; Infectious
MeSH terms: Skin Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The objectives of this study is to evaluate the Safety and Efficacy of Intravenous Daptomycin
      (Cubicin®)Compared with that of Comparator (Vancomycin or Vancomycin Followed by
      Semi-synthetic Penicillin-cloxacillin) in the Treatment of Chinese Subjects with Complicated
      Bacterial Skin and Skin Structure Infection due to Gram-Positive Pathogens.
    


Intervention name(s): Daptomycin; Vancomycin
Intervention type(s): Drug; Drug
Intervention description(s): 4mg/kg IV ; Q 24 hr (once every 24 hours); Vancomycin - 1g per 12 hrs, for 7-14 days
Or switch to
Vancomycin Followed by Semi-synthetic Penicillin-Cloxacillin:
- 1 g every 6 hours or 2 g every 8 hours
Other intervention name(s): Cubicin®
Intervention MeSH terms: Vancomycin; Daptomycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Skin Infections; Complicated Bacterial Skin and Skin Structure Infection due to Gram-positive Pathogens
The Association of Cardiac Ion Channel Related Gene Polymorphism and Prolonged QTc Interval After Endotracheal Intubation
Condition: Emergence Delirium
MeSH terms: Emergence Delirium
Study type: Observational

Summary: 
      The QTc interval is affected by heart rate, medications and changes in the autonomic nervous
      system. The endotracheal laryngoscopy, the necessary step during general anesthesia, prolongs
      QTc interval. Changes in the flow of ion currents could result from the genetic variation of
      myocardial ion channels by gene polymorphism. This study is to investigate the association of
      cardiac ion channel related gene polymorphism and prolonged QTc interval after endotracheal
      intubation in adult patients.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        20-65 years old, scheduled for general anesthesia requiring direct laryngoscopy
Acellular Dermal Matrix Allograft Versus Free Gingival Graft
Condition: Gingiva Atrophy; Gingivitis
MeSH terms: Gingivitis; Gingival Recession
Study type: Interventional

Summary: 
      The present split-mouth controlled randomized clinical trial aimed to evaluate clinical and
      histological results of acellular dermal matrix allograft (ADM) compared to autogenous free
      gingival graft (FGG)
    


Intervention name(s): Control; Acellular Dermal Matrix
Intervention type(s): Procedure; Device
Intervention description(s): Free epithelized gingival graft, harvested from palate, was grafted in a site with lack of keratinized gingiva; Acellular Dermal Matrix was grafted in a site with lack of keratinized gingiva, in substitution of an autogenous graft from patient palate
Other intervention name(s): allograft
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Split-mouth design. One side of mouth was test group, other side was control group.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: gingiva; keratinized mucosa; gingival graft