bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Respiratory Acoustic Monitor in Children After Surgery
Condition: Respiratory Complications; Pediatric
Study type: Interventional

Summary: 
      The study will evaluate the performance of measuring respiration rate with the Respiratory
      Acoustic Monitoring (RAM).
    

Detailed description: 
      The study seeks to determine the reliability and accuracy of the acoustic respiratory
      monitoring (RAM) in comparison of clinically completed transthoracic impedance monitoring
      (TI) and manual counting of respiratory rate in postoperative pediatric patients at risk of
      adverse respiratory events.
    

Intervention name(s): Respiratory Acoustic Monitor
Intervention type(s): Device
Intervention description(s): Examine the reliability and accuracy of the respiratory acoustic monitor.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Respiration Rate; Respiratory Acoustic Monitor; postoperative
Effect of Task Oriented Training and Xbox KinectTM on Hand Function in Pediatric Burn
Condition: Burns; Hand Burn
MeSH terms: Burns
Study type: Interventional

Summary: 
      The Jebsen-Taylor Hand Function Test and Canadian Occupational Performance Measure (COPM)
      were considered as primary outcome measurements. Secondary outcomes included total active
      range of motion (ROM) of the digits, hand grip strength and pinch strengths (tip, palmer and
      lateral pinch). All measurement was conducted at two occasions: at the baseline and after
      intervention.
    

Detailed description: 
      The included participant were children with a deep partial thickness or a full thickness burn
      induced by either a scaled or a flame thermal burn with involvement of more than 50% of the
      hand and wrist, total body surface area (TBSA) less than 30% , age ranged from 7 to 14 years,
      recent discharge of inpatient acute care, spontaneous healing (within 34 weeks) or grafting
      with split thickness or full-thickness skin grafts (at least before 2 weeks). Children were
      excluded from this study if they had infection, juvenile arthritis, fracture, tendon
      injuries, muscle injury, degenerative joint diseases, peripheral nerve diseases, Pre -
      established psychologically and physically disorders (extreme aphasia, cognitive and
      developmental deficits that can influence the rehabilitation).
    

Intervention name(s): control; Xbox kinect; task oriented training
Intervention type(s): Other; Other; Other
Intervention description(s): The traditional therapy included immersing the hand in paraffin for 10 min; soft massaging with a moisturizing gel for 5 min; passive mobilization of the wrist, MP, PIP, and DIP joints; active/passive ROM and stretching exercises; strengthening exercises (done in static mode initially and progressed in the second month to dynamic strengthening using elastic bands); desensitizing sensory stimulation of hypertrophic scars, occupational therapy.; The traditional plus Xbox Kinect games were related to five target activities determined according to the person-centered analysis results were chosen for each patient.; The traditional plus the target activities involved training with the materials (clothes, spoons, pencils, buttons, rope, etc) needed for the activity as well as Velcro cylinders, skill cubes, exercise bands, screw sets, therapeutic putty, and tripled coordination tools.
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Task-oriented training TOT group and Xbox training group were conducted with an average of 50-min sessions three times a week for 8 weeks.
The traditional rehabilitation program conducted for 40-min sessions, three times per week for 8 weeks for all children.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: children burns; Hand Function; Grip strength; pinch strength; Jebsen-Taylor Hand Function Test; Duruoz Hand Index; Canadian Occupational Performance Measure
Coadministration of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) With Ribavirin (RBV) in Adults With Genotype 4 (GT4) Hepatitis C Virus (HCV) in Egypt
Condition: HCV; Hepatitis C Infection; Genotype 4
MeSH terms: Infections; Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluates the efficacy and safety of ABT-450/r/ABT-267 with RBV in treatment-naive
      and treatment-experienced HCV GT4 subjects without or with compensated cirrhosis.
    

Detailed description: 
      Non-cirrhotic subjects were directly enrolled into Arm A. Cirrhotic subjects were randomized
      to either Arm B (12 weeks of treatment) or Arm C (24 weeks of treatment).
    

Intervention name(s): 2 DAA; RBV
Intervention type(s): Drug; Drug
Intervention description(s): ABT-450/r/ABT-267 tablets; Ribavirin tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Genotype 4; non-responder; treatment experienced; HCV; naive; relapser; hepatitis infection; compensated cirrhosis; hepatitis c; Cirrhosis; Egypt; null responder; partial responder
Nutraceutical Supplement With Standardized Botanicals in Males With Thinning Hair
Condition: Hair Thinning
MeSH terms: Alopecia; Alopecia Areata; Hypotrichosis
Study type: Interventional

Summary: 
      The objective of this study is to assess the effectiveness and safety of a novel dietary
      supplement containing botanical ingredients for hair thinning in men over the course of six
      months of continuous daily usage.
    

Detailed description: 
      Hair thinning is a common condition affecting both men and women that is more recently
      understood to be the result of multiple causes. Although it is generally a benign condition,
      hair thinning can have a significant, detrimental impact on self-esteem, psychosocial
      functioning and the overall quality of life of affected individuals. It can also represent a
      substantial financial burden on individuals seeking treatment.

      The objective of this randomized, double-blind, placebo-controlled study is to assess the
      effectiveness and safety of a novel dietary supplement containing botanical ingredients for
      hair thinning over the course of six months of continuous daily usage. The study supplement
      is scientifically formulated to specifically target the multiple underlying causes of hair
      thinning. In addition to the necessary vitamins, minerals, and proteins to support the
      nutritional needs of hair, it also contains clinically tested, standardized
      pharmaceutical-grade botanicals (substances obtained from plants) that target hormones,
      stress and inflammatory markers.
    

Intervention name(s): Nutrafol® Men Hair Growth Nutraceutical; Placebo Supplement
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Nutrafol® Men contains patented Synergen Complex® is a blend of proprietary formulation of botanicals with potent anti-inflammatory, anti-stress adaptogenic, antioxidant and DHT-inhibiting properties - combined to synergistically combat the multiple underlying factors that compromise hair growth and health. These ingredients include Sensoril Ashwagandha, BCM-95 BioCurcumin, USPlus Saw Palmetto, EVNolMax 20% Tocotrienol/Tocopherol complex, Bioperine (piperine), Cynatine HNS (solubilized keratin), and Capsimax (capsaicin).; The placebo capsules contain no active ingredients.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a 6-month, multi-center, randomized, double-blind, placebo-controlled study in adult male subjects with self-perceived hair thinning. Subjects will be randomly assigned to either Nutrafol® Men hair growth supplement or placebo.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Nutraceutical; Supplement
Nasal Epithelium Gene Expression Profiling in Child Respiratory Allergic Disease
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional

Summary: 
      Using a human pangenomic microarray, the researchers established expression profiles of nasal
      epithelial cells, collected by brushing of patients belonging to one of four distinct groups:

        1. allergic rhinitis to dust mite (AR) isolated (n=12),

        2. AR associated with bronchial hyperreactivity (n=12),

        3. AR associated with asthma (n=14),

        4. control (n=14).
    

Detailed description: 
      Context: Asthma is the most frequent chronic disease in childhood. Allergic rhinitis has been
      described as a risk factor to develop asthma. The objective of the study was to evaluate the
      contribution of the respiratory epithelium to development of allergic rhinitis and asthma and
      to identify the molecular mechanisms driving rhinitis toward asthma.

      Methods: Using a human pangenomic microarray, we established expression profiles of nasal
      epithelial cells, collected by brushing of patients belonging to one of four distinct
      children 2 to 18 years of age groups:

        1. allergic rhinitis to dust mite (AR) isolated (n=12),

        2. AR associated with bronchial hyperreactivity (n=12),

        3. AR associated with asthma (n=14),

        4. control (n=14).
    

Intervention name(s): Collection of nasal epithelial cells
Intervention type(s): Procedure
Intervention description(s): Collection of nasal epithelial cells by brushing
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: allergic rhinitis to dust mite; allergic rhinitis associated with bronchial hyperreactivity; allergic rhinitis associated with asthma
Phase 1 Study of OLZ/SAM in Pediatric Subjects With Bipolar I Disorder
Condition: Bipolar I Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety, tolerability, and pharmacokinetics of olanzapine and samidorphan in
      clinically stable pediatric subjects (10 to 12 years old) with Bipolar I disorder following
      oral administration of multiple ascending doses of OLZ/SAM
    


Intervention name(s): OLZ/SAM
Intervention type(s): Drug
Intervention description(s): Olanzapine and Samidorphan taken once daily over a max period of 21 days
Other intervention name(s): ALKS 3831
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bipolar I Disorder; Olanzapine; Samidorphan; OLZ/SAM; ALKS 3831; Pediatric pharmacokentics; LYBALVI
Chemotherapy and Whole-Brain Radiation Therapy in Treating Patients With Primary Central Nervous System Non- Hodgkin's Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.
      Combining radiation therapy with chemotherapy may kill more tumor cells and may be an
      effective treatment for non-Hodgkin's lymphoma.

      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and
      whole-brain radiation therapy in patients with primary central nervous system non-Hodgkin's
      lymphoma.
    

Detailed description: 
      OBJECTIVES: I. Assess the response to CHOD (cyclophosphamide/doxorubicin/vincristine/
      dexamethasone) and BVAM (carmustine/vincristine/cytarabine/methotrexate) plus whole-brain
      radiotherapy in patients with primary central nervous system non-Hodgkin's lymphoma (PCNSL).
      II. Assess the toxic effects associated with this treatment. III. Assess the survival of
      patients with PCNSL receiving this treatment. IV. Investigate the frequency of systemic
      involvement at follow-up. V. Identify factors that appear to be associated with outcome.
    

Intervention name(s): carmustine; cyclophosphamide; cytarabine; dexamethasone; doxorubicin hydrochloride; methotrexate; vincristine sulfate; low-LET cobalt-60 gamma ray therapy; low-LET photon therapy
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Radiation; Radiation
Intervention MeSH terms: Cobalt; Cytarabine; Dexamethasone; Cyclophosphamide; Carmustine; Doxorubicin; Liposomal doxorubicin; Methotrexate; Vincristine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: primary central nervous system non-Hodgkin lymphoma
Assessment of Emotion-regulation Skills in Game-based Situations
Condition: Emotional Problem
Study type: Interventional

Summary: 
      The aim of the study is to investigate the validity of in-game scores as indicators for
      emotional regulation abilities in children and adolescence.
    


Intervention name(s): REThink therapeutic game
Intervention type(s): Other
Intervention description(s): REThink is a online therapeutic game developed by David and collaborators (2018), proved to be an efficient intervention to reduce emotional symptoms of children and adolescents.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: emotional regulation; online therapeutic game; emotional regulation assessment
Working Memory Training and Neurofeedback for Children With ADHD, a Pilot Study
Condition: ADHD
Study type: Interventional

Summary: 
      This pilot study compares the effect of working memory training and neurofeedback in
      non-medicated children age 7 to 13 years with ADHD. Half of the participants will receive
      working memory training, while the other half will receive neurofeedback.
    


Intervention name(s): Cogmed Robomemo, working memory training; Othmer, neurofeedback
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Kava for the Treatment of Generalised Anxiety Disorder: A Double-Blind Randomised Placebo-Controlled Trial
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The use of Kava in Generalised Anxiety Disorder: an 18-week double-blind, randomised,
      placebo-controlled study.
    

Detailed description: 
      The primary aim is to confirm the efficacy and safety of Kava compared to placebo in
      Generalized Anxiety Disorder (GAD). Secondary aims of the study are to confirm the
      relationship between specific genetic variations and response to Kava, and to explore the
      effects of Kava on the expression of specific genes.

      Consenting participants will be randomly allocated to take either Kava or placebo over 18
      weeks. They will be assessed at regular interviews throughout the trial and will have four
      blood tests (liver function tests to monitor participant safety, and collection of genetic
      material providing information on neurochemistry). The design of the study is a multi-centre,
      18-week, 2-arm, double-blind randomised clinical trial (RCT) using a standardised
      pharmaceutical-grade water-soluble extract of Kava (240mg of kavalactones per day) versus
      placebo in 210 adults with GAD.
    

Intervention name(s): Kava (240mg of kavalactones per day); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Kava 60 milligrams per tablet = 240mg of kavalactones per day; Inert tablets containing vegetable fibre matched for colour, size and consistency to active arm treatment.
Other intervention name(s): Kava; Kavalactones; Piper methysticum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Kava; Anxiety; Generalized Anxiety Disorder; Psychiatric; Anxiolytic; GABA; Kavalactones
A Study to Characterize the Abuse Liability of Intravenous Oxycodone Alone or in Combination With Intravenous Naltrexone in Healthy, Non-Dependent, Recreational Opioid Users
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to simulate if oxycodone and naltrexone combination
      capsules (ALO-02) were to be tampered with by dissolving and then injecting intravenously for
      the purpose of getting high.
    


Intervention name(s): Placebo; Oxycodone + Naltrexone; Oxycodone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0.9% sodium chloride for injection x 1 dose administered intravenously (IV) push over 4 min.; Oxycodone hydrochloride (HCl) 20 mg IV and naltrexone HCl 2.4 mg IV administered simultaneously x 1 dose IV push over 4 min.; Oxycodone HCl 20 mg for injection x 1 dose IV push over 4 min.
Intervention MeSH terms: Naltrexone; Oxycodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: abuse potential; abuse liability; drug liking; oxycodone; naltrexone; intravenous; pharmacodynamic
Comparison of Intraoperative and Postoperative Outcomes of Bartholin Gland Marsupialisation Versus Cystectomy
Condition: Bartholin Abscess
MeSH terms: Abscess
Study type: Interventional

Summary: 
      To compare intraoperative and postoperative outcomes of Bartholin marsupialisation versus
      excision
    

Detailed description: 
      Bartholin cysts and abscess are commonly seen. Different surgical procedures are done for
      therapy. Our aim is to compare intraoperative results and postoperative healing of patients
      undergoing marsupialisation versus excision.
    

Intervention name(s): Excision; Marsupialization
Intervention type(s): Other; Other
Intervention description(s): Bartholin gland will be excised; Bartholin gland will be marsupialised
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: bartholin; marsupialisation; abscess
A Study in Adults and Adolescents With Angelman Syndrome (STARS)
Condition: Angelman Syndrome
MeSH terms: Angelman Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to assess the safety and tolerability of oral OV101 (gaboxadol)
      in adult and adolescent subjects with Angelman syndrome. In addition, several exploratory
      efficacy outcome measures will be investigated.
    

Detailed description: 
      Two dosing schedules of OV101 (gaboxadol) giving as once daily or twice daily dose will be
      assessed against placebo.
    

Intervention name(s): OV101 Regimen 1; OV101 regimen 2; Placebo
Intervention type(s): Drug; Drug; Other
Other intervention name(s): Gaboxadol; Gaboxadol
Intervention MeSH terms: Gaboxadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Metabolic Syndrome and Obstructive Sleep Apnea
Condition: Sleep Apnea; Metabolic Syndrome
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Metabolic Syndrome; Syndrome
Study type: Observational

Summary: 
      Background:Metabolic syndrome is a disorder characterized by abdominal
      obesity,hypertension,increased triglycerides ,decreased HDL cholesterol and increased blood
      glucose. Accumulating evidence strongly indicates that insulin resistance and an increased
      amount of abdominal fat are the pathogenic factors for the characteristics of metabolic
      syndrome. Studies indicate that sleep apnea may be a manifestation of the metabolic syndrome.

      Subjects and methods:This study was conducted in the pulmonology department at kasrelainy
      hospital. It included 80 patients who came to the sleep lab unit for polysomnography. Each
      patient was subjected to full history taking including(sex,age,smoking history,presence of
      diabetes or hypertension),thorough clinical examination with emphasis on waist, neck&hip
      circumference and blood pressure measurements,Laboratory investigations including :Lipid
      profile& Diabetic profile(HBA1C).In addition to ESS and stop bang score questionnaire.
    


Intervention name(s): sleep study
Intervention type(s): Diagnostic Test
Intervention description(s): over-night polysomnography
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        This study was conducted in the pulmonology department at kasrelainy hospital.Itincluded 80
        patients who came to the sleep lab unit for polysomnography.Each patient was subjected to
        full history taking including(sex,age,smoking history,presence of diabetes or
        hypertension),thorough clinical examination with emphasis on waist, neck & hip
        circumference and blood pressure measurements,Laboratory investigations including: Lipid
        profile&Diabetic profile(HBA1C).In addition to ESS and stop-bang score questionnaire
      
Biospecimen description: 
      blood sampling for lipid profile and HBAIC
Effect of a Combination of Hyaluronic Acid, Chondroitin Sulphate and Magnesium Trisilicate on Subjects With GastroEsophageal Reflux Disease
Condition: Gastro Esophageal Reflux
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Interventional

Summary: 
      The aim of this study is to investigate whether a 3-week treatment with an oral melt in mouth
      medical device, made up with hyaluronic acid, chondroitin sulphate and magnesium trisilicate,
      can lead to a reduction of Gastroesophageal Reflux Disease symptoms and to an improvement of
      the integrity of esophageal mucosa in patients who are to experiencing esophagus symptoms.
      The study is a randomized, double-blind cross-over placebo controlled study. Every patient
      will get both the active study device during one study period and placebo during another
      another period.
    


Intervention name(s): hyaluronic acid with chondroitin + sulphate + magnesium trisilicate; Placebo
Intervention type(s): Device; Device
Intervention description(s): Melt in mouth tablets (1100 mg); tablets with the same aspect of the active device
Other intervention name(s): GERDOff Plus; Placebo (for hyaluronic acid with chondroitin + sulphate + magnesium trisilicate)
Intervention MeSH terms: Magnesium trisilicate; Hyaluronic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment