bioihbjkbjnl/mcl2 huggingface dataset:
Effect of the Cardio First Angle Device on CPR Outcomes
Condition: Cardiopulmonary Arrest
MeSH terms: Heart Arrest
Study type: Interventional

Summary: 
      The investigators conducted a randomized, controlled, single-blinded study of patients
      undergoing CPR for cardiac arrest in the mixed medical-surgical ICUs of four academic
      teaching hospitals in Tehran, Iran from June 1 to October 31, 2014. Patients were randomized
      to receive CPR with either standard manual compression, or compression with real-time
      audiovisual feedback using the Cardio First Angel™ device.
    

Detailed description: 
      The investigators sought to determine if the addition of a CPR feedback device to routine
      manual CPR would impact the quality and consistency of chest compression and patient
      survival. We conducted a randomized, controlled, single-blinded study of patients undergoing
      CPR for cardiac arrest in the mixed medical-surgical ICUs of four academic teaching
      hospitals. Patients were randomized to receive either standard manual CPR or CPR using the
      Cardio First Angel™ (CFA; INOTECH, Nubberg, Germany) feedback device. Recorded variables
      included return of spontaneous circulation, adherence to CPR guidelines and quality of CPR,
      nurse satisfaction and CPR associated morbidity.
    

Intervention name(s): Compression with Feedback; Standard chest compression
Intervention type(s): Device; Other
Intervention description(s): Patients in the intervention group received CPR in accordance to published guidelines using the CFA device per manufacturer instructions. The Cardio First Angel™ (CFA; INOTECH, Nubberg, Germany) is a lightweight device that consists of three components . Application of400 ± 30 Newtons of force (41 kg or 90 lb of pressure), which correlates toa sternum compression depth of 50-60 mm, is followed by an audible "click" sound to alert the rescuer to cease compression. The "click" sound is also audible upon spring decompression alerting the rescuer to resume compression. The device does not require an electrical power supply.; CPR in accordance with published international guidelines using standard manual chest compression.
Other intervention name(s): Cardio First Angel™
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: CPR; Cardio first angle; Clinical trial
Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Subjects From 2 to 75 Years of Age in India
Condition: Bacterial Meningitis
MeSH terms: Meningitis, Bacterial; Meningitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the immunogenicity of a single injection of Novartis Meningococcal
      ACWY conjugate vaccine in healthy subjects from the age of 2 years and above in India.
    


Intervention name(s): Meningococcal ACWY conjugate vaccine
Intervention type(s): Biological
Intervention description(s): All subjects received a single dose of Meningococcal ACWY conjugate vaccine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningococcal,; ACWY,; bacterial meningitis,; conjugate vaccine,; healthy, children,; adolescents,; adults,; India
Hydrocortisone in the Treatment of Intrusions in Patients With Posttraumatic Stress Disorder
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      To test overall efficacy of hydrocortisone on reexperience of traumatic memories (intrusions)
      and overall symptomatology in patients meeting criteria of complex chronic PTSD.
    


Intervention name(s): Arm 1 Hydrocortisone 10 mg; Arm 2 Hydrocortisone 30 mg
Intervention type(s): Drug; Drug
Intervention description(s): Group 1: Administration of Hydrocortisone and/or Placebo in the following order:
1 week placebo- 1 week 10 mg hydrocortisone - 1 week placebo - 1 week 30 mg hydrocortisone; Drug: Hydrocortisone 30 mg
Group 2: Administration of Hydrocortisone and/or Placebo in the following order:
1 week hydrocortisone 30 mg/d- 1 week placebo - 1 week hydrocortisone 10 mg/d - 1 week placebo
Intervention MeSH terms: Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Effectiveness of an Online Prevention Program in Reducing the Risk of STD Infection in Young Adults
Condition: HIV Infections; Sexually Transmitted Diseases
MeSH terms: Infections; Sexually Transmitted Diseases
Study type: Interventional

Summary: 
      This study will evaluate the effectiveness of a tailored interactive online risk reduction
      program versus a standard online risk reduction program in reducing the risk of Sexually
      Transmitted Diseases (STD) infection in young adults.
    

Detailed description: 
      Adolescents and young adults are at the greatest risk for acquiring an STD. Approximately 3
      million people between the ages of 18 and 24 become infected each year. Education about the
      risks and consequences of unprotected sex is a powerful tool that can be used to prevent or
      reduce the risk of infection. The program in this study will deliver messages to educate
      participants about condom use and the risk of STD infection. This study will evaluate the
      effectiveness of a tailored interactive online risk reduction program versus a standard
      online risk reduction program in reducing the risk of STD infection in young adults.

      Participants in this 1-year open-label study will be recruited exclusively via the internet.
      Participants will be randomly assigned to receive internet-based messages from either the
      Youthnet program or the control program. Messages from the Youthnet program will be
      interactive and tailored specifically to Human Immunodeficiency Virus/Sexually Transmitted
      Diseases (HIV/STD) risk reduction. The control program will deliver standard STD/HIV
      prevention messages. Participants will be assessed at baseline and a follow-up session 4
      months after enrollment. Frequency of condom use and attitudes toward condom use will be
      assessed using behavioral scales.
    

Intervention name(s): Youthnet Internet-based program; Control Internet based program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Messages from the Youthnet program will be interactive and tailored specifically to HIV/STD risk reduction. Participants will be exposed to five flash computer vignettes of 30 seconds each, concerning condom attitudes, norms self-efficacy, and risk awareness.; The control program will deliver standard STD/HIV prevention messages.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV Prevention; Internet Intervention; STDs
A Study of Herceptin (Trastuzumab) in Combination Chemotherapy in Patients With Metastatic or Locally Advanced Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will define an optimal chemotherapy dose regimen of Myocet in combination with
      paclitaxel and intravenous Herceptin and will evaluate the efficacy and safety of this dose
      regimen in patients with metastatic or locally advanced breast cancer and HER2
      overexpression. The anticipated time on study treatment is 3-12 months.
    


Intervention name(s): trastuzumab; paclitaxel; Myocet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Initial loading does of 4 mg/kg IV, followed by 2 mg/kg IV weekly, until disease progression; 60 mg/m^2 IV weekly; dose increased to 70 mg/m^2, and subsequently 80 mg/m^2, after 2 treatment cycles with no evidence of DLT until disease progression; 40 mg/m^2 IV weekly; dose increased to 50 mg/m^2 IV after 2 treatment cycles with no evidence of DLT for 6 cycles
Other intervention name(s): Herceptin
Intervention MeSH terms: Paclitaxel; Trastuzumab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate Leuprolide Acetate 45 mg 6-Month Formulation in Children With Central Precocious Puberty (CPP)
Condition: Central Precocious Puberty (CPP)
MeSH terms: Puberty, Precocious
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the study is to assess the safety and efficacy of a leuprolide
      acetate (LA) 45 mg 6-month depot formulation for the treatment of CPP in children who are
      either naïve to treatment with a gonadotropin-releasing hormone agonist (GnRHa) or who have
      been previously treated with a GnRHa.
    


Intervention name(s): Leuprolide Acetate (LA)
Intervention type(s): Drug
Intervention description(s): Administered intramuscularly as an injection
Other intervention name(s): Lupron Depot
Intervention MeSH terms: Leuprolide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Central Precocious Puberty (CPP); Leuprolide Acetate (LA)
Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function
Condition: Growth Hormone Disorder; Adult Growth Hormone Deficiency; Growth Hormone Deficiency in Children
MeSH terms: Dwarfism, Pituitary; Renal Insufficiency; Endocrine System Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The trial is conducted in Europe. The aim of the trial is to investigate the steady state
      exposure of somapacitan in subjects with various degrees of renal impairment (mild, moderate,
      severe renal impairment, requiring haemodialysis treatment) compared to subjects with normal
      renal function
    


Intervention name(s): Somapacitan
Intervention type(s): Drug
Intervention description(s): All subjects will receive three (0.08 mg/kg) consecutive once-weekly s.c. (under the skin) administrations of somapacitan
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Trial of Radiofrequency Ablation for Anal Intraepithelial Neoplasia Using the HALO Ablation System
Condition: HIV-negative Subjects With Intra-anal Intraepithelial Neoplasia Containing High-Grade Squamous Intraepithelial Lesions
MeSH terms: Neoplasms; Carcinoma in Situ
Study type: Interventional

Summary: 
      This is a Single-center prospective pilot trial involving up to 22 subjects. This study will
      assess the feasibility, safety, and efficacy of radiofrequency ablation (RFA) to the anal
      canal using the FDA cleared HALO Ablation System to eradicate anal HSIL lesions in
      HIV-negative subjects with intra-anal intraepithelial neoplasia (AIN). The study intervention
      will demonstrate that a reasonable proportion of subjects will be histologically cleared of
      their anal HSIL within the ETZ in a tolerable and relatively safe manner
    


Intervention name(s): Radiofrequency Ablation (RFA) using the HALO Ablation System
Intervention type(s): Device
Other intervention name(s): Barrx Ablation System
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Anti-Inflammatory Agent in Sinusitis
Condition: Nasal Polyps
MeSH terms: Sinusitis; Nasal Polyps
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the efficacy of an anti-inflammatory agent compared with placebo in relieving
      signs and symptoms of disease in patients with sinusitis.
    

Detailed description: 
      This is a Phase 2a, single-center, randomized, placebo-controlled, double-blind study that
      includes 12 weeks of treatment with experimental drug anti-inflammatory agent or placebo TID
      administered orally.

      All subjects will be ≥18 years, have sinusitis with persistent symptoms despite standard of
      care treatment, and have failed a course of steroids in the past.
    

Intervention name(s): AZ compound; Collection of Biological Specimens; Intranasal corticosteroid; Placebo
Intervention type(s): Drug; Other; Drug; Drug
Intervention description(s): 40 mg three times daily po for 12 weeks; collection of biomarkers for analysis of nasal disease; QD Nasal Spray; looks like AZ compound, made by same company, double blind. 40 mg three times daily po for 12 weeks
Other intervention name(s): Biomarkers; Nasal Steroid (Nasonex, Flonase)
Intervention MeSH terms: Mometasone Furoate; Fluticasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Intrastromal Corneal Ring Segment Implantation in 219 Keratoconic Eyes at Different Stages
Condition: Keratoconus
MeSH terms: Keratoconus
Study type: Observational

Summary: 
      The purpose of this study is to properly analyse the visual and refractive outcomes of
      implantation of KeraRing intrastromal corneal ring segment (ICRS) at the different stages of
      keratoconus.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with keratoconus (stage I; stage II and stage III,according to the Amsler-Krumeich
        keratoconus classification) in whom KeraRing ICRS were implanted at the Fernández-Vega
        Ophthalmological Institute, Oviedo, Spain.
      
Keywords: Keratoconus; intrastromal corneal ring segment; To evaluate the visual and refractive outcomes of intrastromal corneal ring segment in keratoconic eyes at different stages
Study to Evaluate Safety, Tolerability and Immunogenicity of Vaccine (UB 311) in Subjects With Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this Phase I study is to determine whether the vaccine (UB 311), targeting the
      amyloid beta peptide (N-terminal amino acids, 1-14), is safe and immunogenic in patients
      diagnosed with mild or moderate Alzheimer's disease (AD). Amyloid beta was selected as the
      target antigen based on supporting evidence of the hypothesis that places the accumulation of
      amyloid beta at the initiating step of AD.
    


Intervention name(s): UB 311
Intervention type(s): Biological
Intervention description(s): Single liquid dose by intramuscular route at weeks 0, 4, 12.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alzheimer's disease; amyloid beta; vaccine
Nutrition to Relieve IBS Symptoms by Targeting the Microbiota
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome
Study type: Interventional

Summary: 
      Rationale: Irritable Bowel Syndrome (IBS) is functional gastrointestinal disorder that
      affects a large number of people. To date, no adequate treatment is available. This is
      partially due to the heterogeneity of the patients and the complicated pathology in which not
      all mechanisms are understood.

      Based on results of in vitro screening within the IBSQUtrition project, we selected promising
      dietary supplements for validation of their potential beneficial effects on the microbiota of
      IBS patients.

      Objective: The primary objective is to determine the bifidogenic effects of a 4-week
      intervention with one of four dietary supplements (Chondroitin sulfate, NOVELOSE® 3490, and
      Pea Fiber, and Lactium®) in IBS patients. The secondary objective is to determine the effects
      of the same intervention on fecal microbiota composition and SCFA concentration, IBS-related
      complaints, Quality of Life, and stool frequency and consistency in IBS patients.

      Study design: a double-blind, randomized, placebo-controlled trial with five parallel arms.
      Study population: 70 adult (18-65 yrs) IBS patients Intervention: 4-week intervention period
      with five parallel arms: 1) Chondroitin sulfate, 2) NOVELOSE® 3490, 3) Pea Fiber, 4)
      Lactium®, and 5) Placebo supplement (Maltodextrin control), during which the study
      participants consume the respective supplement twice per day.

      Main study parameters/endpoints: The main study parameter is the (relative) abundance of
      fecal Bifidobacterium. The secondary study parameters are fecal microbiota composition and
      Short-Chain Fatty Acids (SCFAs) concentration, stool frequency and consistency, IBS-related
      complaints, and Quality of Life (QoL).

      Nature and extent of the burden and risks associated with participation, benefit and group
      relatedness: Study participants have to invest about 7.4 hours of their time in this study
      mainly to complete several questionnaires (short daily questionnaire, longer questionnaires
      at two occasions), which is conveniently all possible from home. On two occasions they have
      to collect stool (transported via courier to the research facility). They have to comply to
      consume a commercially available supplement twice daily for four weeks. There are limited
      risks for the study participants.
    


Intervention name(s): Dietary fiber supplement; Caseine protein hydrolisate; Maltrodextrine
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Dietary fiber; Dietary supplement; Placebo comparator
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: gut Microbiota
Surface EMG and Ultrasound in MND
Condition: Motor Neuron Disease
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis
Study type: Interventional

Summary: 
      Patients with motor neurone disease typically experience relentless motor decline and die
      within three years of symptom onset from respiratory muscle weakness. There are currently no
      effective therapies and the discovery of novel therapies is hampered by the lack of a
      sensitive disease biomarker. Consequently, there is a huge drive to discover novel
      biomarkers, which can reliably track disease progression over time. These can then be
      incorporated into clinical drug trials to expedite effective drug discovery.

      Muscle fasciculations represent the hyperexcitability of diseased motor neurons and are
      almost universally present from the early stages of MND. We predict that the site, frequency
      and shape of fasciculations might provide a sensitive measure of disease progression in an
      individual.

      We have been conducting a 12-month longitudinal study of 25 patients, performing high-density
      surface EMG every two months. We have validated an automated technique to process these large
      data sets. Ultrasound is widely used in clinical medicine to assess anatomical structure in a
      safe and non-invasive way. Dr Emma Hodson-Tole (Manchester Metropolitan University) and her
      group have been applying this to the analysis of fasciculations in healthy individuals and
      patients with MND.

      This collaborative project will explore combining these two techniques simultaneously in
      patients with motor neuron disease and control subjects. The goal is to explore the nature of
      electro-mechanical coupling related to fasciculations and to determine whether any of these
      properties are pathophysiological. This would complement other studies from our two groups,
      investigating the natural history and potential utility of fasciculations as a biomarker of
      motor neuron health in MND.
    


Intervention name(s): High-density surface EMG; Ultrasound
Intervention type(s): Device; Device
Intervention description(s): High-density surface EMG for fasciculation detection; Ultrasound for fasciculation detection
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: 12 MND/ALS patients and 13 healthy controls to be assessed at a single time-point each
Masking: None (Open Label)
Primary purpose: Other
Safety and Tolerability Study of QLS-101 in Adolescents With Sturge-Weber Syndrome (SWS)-Related Glaucoma Due to Elevated Episcleral Venous Pressure (EVP)
Condition: Sturge-Weber Syndrome; Glaucoma; Ocular Hypertension
MeSH terms: Sturge-Weber Syndrome; Brain Stem Infarctions; Glaucoma; Ocular Hypertension; Klippel-Trenaunay-Weber Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Open-label study of an investigational product (IP), QLS-101, with 28-day every morning (QAM)
      dosing to both eyes (OU) in adolescents with SWS who have clinical evidence of glaucoma
      and/or ocular hypertension (OHT) related to SWS elevated EVP in at least one eye.
    


Intervention name(s): QLS-101 ophthalmic solution, 2.0 %
Intervention type(s): Drug
Intervention description(s): ophthalmic solution in a single use dropper vial
Other intervention name(s): QLS-101
Intervention MeSH terms: Ophthalmic Solutions
Intervention model: Single Group Assignment
Intervention model description: Open-label, single treatment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetic Study of Dexmedetomidine After Intra-nasal Dosing in Children
Condition: Heart Disease
MeSH terms: Heart Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This research study is examining the absorption of the sedative dexmedetomidine (DEX) in the
      blood when given by nasal spray. The study will help us determine the best dosing amount for
      children undergoing sedation or anesthesia with DEX.
    

Detailed description: 
      The study will be a prospective study of plasma concentrations after intranasal (1 µg/kg and
      2µg/kg) and intravenous (1 µg /kg) DEX to determine the early pharmacokinetics (maximum
      concentration (peak) and time to peak) and bioavailability of a single intranasal dose in
      pediatric patients.

      Dexmedetomidine sedation is commonly utilized at Cincinnati Children's Medical Center (CCHMC)
      and other pediatric institutions. This compound is delivered intravenously or intranasally
      for sedation in children with and without congenital heart disease. Intranasal DEX, though
      very effective for sedation, has significant variability in its onset and peak effect.
      Patient care will be significantly improved if factors that determine this variability in
      onset and peak effect can be determined. Investigators will determine the important early
      clinical variables of peak plasma DEX concentration (Tmax and Cmax) and the 0 - 2 hour
      bioavailability of intranasal DEX in children.
    

Intervention name(s): Dexmedetomidine 1mcg/kg Intranasal; Dexmedetomidine 2mcg/kg Intranasal; Dexmedetomidine 1mcg Intravenous
Intervention type(s): Drug; Drug; Drug
Intervention description(s): DEX 1 mcg/kg Intranasal; DEX 2 mcg/kg Intranasal; DEX 1 mcg/kg Intravenously
Intervention MeSH terms: Dexmedetomidine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pediatric; Sedation; Dexmedetomidine