bioihbjkbjnl/mcl2 huggingface dataset:
Rehabilitation in Chronic Obstructive Pulmonary Disease (COPD) Patients With Emphysema
Condition: Chronic Obstructive Pulmonary Disease; Emphysema
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
Study type: Observational

Summary: 
      Chronic Obstructive Pulmonary Disease has two heterogeneous conditions (chronic bronchitis
      and pulmonary emphysema phenotypes) with a different clinical presentation.

      The phenotype evaluation in COPD patient (trough clinical, functional and radiographic
      parameters) could influence final results in pharmacologic and non-pharmacologic management
      of the disease.

      The aim of our study is to investigate whether COPD patients with different disease phenotype
      (chronic bronchitis versus pulmonary emphysema) have a different response to PR.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        COPD patients with or without Emphysema phenotype
      
Keywords: COPD; Emphysema phenotype
Effects of Telemonitoring Service for Obesity Care
Condition: Obesity; Metabolic Syndrome
MeSH terms: Obesity; Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      A randomized, open, parallel, multi-center trial to evaluate weight loss efficacy of Smart
      Care Service in obese patients with metabolic syndrome.
    

Detailed description: 
      1. Objectives : To evaluate superiority of U(Ubiquitous)-Healthcare(hereinafter referred to
           as Smart Care) Service being combined conventional treatment with health care service,
           in comparison to conventional treatment in obese patients with metabolic syndrome.

        2. Test and control group

             -  Test groups : The subject group who is receiving health care services using
                conventional treatment (hospital visit) and Smart Care Service (Telemonitoring).

             -  Control group : The subject group who is receiving conventional treatment (hospital
                visit).

        3. Target Subject: Obese patients with metabolic syndrome.
    

Intervention name(s): Telemonitoring; control group
Intervention type(s): Procedure; Other
Intervention description(s): The Telemonitoring group will be provided the Smartphone, body composition analyzer and pedometer. They should visit the site once per every 3 months (12 weeks), and measure their body composition during study period. After measurement of body composition, the subjects should make transmit measured information through Smartphone into a centralized server of Smart Care Center. At Smart care Center, care manager will provide remote body composition and activity monitoring and individual obesity case management; The control group will receive a weighting scale and pedometer. They should perform the same weight measurement (minimum three times a week) like the intervention group during the study, and measured results should be recorded in a diary of self body weight and the number of steps. In addition, the subjects should visit the site once per every three months (12 weeks).
Other intervention name(s): Smartcare System : Telemonitoring; Self Body Weight measurement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: telemonitoring; usual care; telehealth; home care; Health Care Quality; Access; Evaluation
Assess the Non-inferiority of GSK Biologicals' Mencevax™ ACWY (Manufactured by a New Process) vs Mencevax™ ACWY (the Already Existing Vaccine in the Market) When Given as a Single Dose to Subjects Aged 2-30 Yrs
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate that the vaccine produced with the new process and
      administered as a single dose is at least as good as the existing Mencevax™ ACWY vaccine in
      terms of immunogenicity, safety and reactogenicity, in healthy subjects aged 2-30 years.
    

Detailed description: 
      "Randomized study with four groups to receive one of the following vaccination regimens: -
      One of the 3 lots of GSK Biologicals' Mencevax™ ACWY vaccine manufactured by the new process
      (3 different groups) - GSK Biologicals' already existing Mencevax™ ACWY
    

Intervention name(s): Mencevax ACWY
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Neisseria meningitidis serogroups A & C diseases; Hib diseases
FIRE AND ICE II Trial Pilot
Condition: Persistent Atrial Fibrillation; Atrial Arrhythmia
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      The FIRE AND ICE II Trial (Pilot) is the pilot phase of a prospective, randomized,
      single-blinded, multi-center, interventional post-market clinical trial, comparing efficacy
      and safety of isolation of the pulmonary veins (PVI) using a Cryoballoon catheter or
      radiofrequency ablation with a ThermoCool® Smarttouch® catheter in subjects with persistent
      atrial fibrillation (AF).
    

Detailed description: 
      60 patients with persistent AF will be randomized 1:1 between Cryoballoon ablation and
      Radiofrequency ablation in the FIRE AND ICE II Trial Pilot at 5 clinical sites in Europe.

      The data collected within the pilot phase will be reviewed and a decision on extending the
      trial with an extended number of patients and sites as main phase will be taken.
    

Intervention name(s): Cryoballoon (Arctic Front Advance Cryoballoon); Radiofrequency Catheter (ThermoCool Smarttouch)
Intervention type(s): Device; Device
Intervention description(s): Ablation using a Cryoballoon catheter (Arctic Front Advance Cryoballoon Cardiac Ablation Catheter); Ablation using a Radiofrequency ablation catheter (ThermoCool Smarttouch catheter)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomization 1:1 between Cryoballoon ablation and Radiofrequency ablation
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ablation; Cryoballoon; Radiofrequency
Bioavailability Study of 2 Oral Formulations of ALXN1840
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will assess the relative bioavailability of 2 different formulations of ALXN1840 in
      healthy participants.
    

Detailed description: 
      This is a two-way crossover study consisting of 2 dosing periods assessing a test and
      reference formulation of ALXN1840. A dose-proportionality parallel group design extension
      period will be conducted following completion of the two-way crossover period of the study
      and will assess 5 different ascending doses of ALXN1840. There will be at least a 14-day
      washout following doses between Periods 1 and 2 and also at least a 14-day washout following
      the dose in Period 2 and the following dose in the Dose-Proportionality Extension Period.

      Safety will be assessed throughout the study.
    

Intervention name(s): ALXN1840
Intervention type(s): Drug
Intervention description(s): ALXN1840 will be administered orally.
Other intervention name(s): Tiomolibdate choline; Tiomolibdic acid
Intervention MeSH terms: Choline
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a 2-period, 2-sequence, crossover study with a parallel group extension.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioavailability; Healthy
Study Investigating the Effect of Lu AF35700 on Cardiac Repolarization in Men and Women With Schizophrenia and Schizoaffective Disorder
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the effect of Lu AF35700 on electrical activity
      in the heart as measured on an electrocardiogram (ECG) in patients with schizophrenia or
      schizoaffective disorder after 6 weeks of treatment
    


Intervention name(s): Lu AF35700 (10 mg/day); Lu AF35700 (30 mg/day); Quetiapine (Seroquel XR® 800 mg/day)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): tablets for oral administration once daily; tablets for oral administration once daily; tablets for oral administration once daily
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety and Pharmacokinetics of Repeat Doses of CSL324 in Subjects With Hidradenitis Suppurativa and Palmoplantar Pustulosis
Condition: Hidradenitis Suppurativa; Palmoplantar Pustulosis
MeSH terms: Hidradenitis Suppurativa; Hidradenitis; Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      Study CSL324_1002 will investigate the safety and pharmacokinetics of repeat doses of CSL324
      in subjects with hidradenitis suppurativa and palmoplantar pustulosis. CSL324 is a novel,
      recombinant therapy that may treat diseases caused by increased numbers of neutrophils at
      sites of inflammation.
    


Intervention name(s): Recombinant anti-granulocyte colony-stimulating factor (G-CSF) receptor monoclonal antibody
Intervention type(s): Biological
Intervention description(s): Recombinant anti-G-CSF receptor monoclonal antibody is a preservative-free, sterile liquid formulation that is suitable for intravenous infusion
Other intervention name(s): CSL324
Intervention MeSH terms: Antibodies; Antibodies, Monoclonal; Lenograstim
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Oral Status and Prevalence of Dental Trauma in Children Treated With Ritalin Due to Attention-Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Disorder With Hyperactivity; Dental Caries; Dental Occlusion, Traumatic
MeSH terms: Dental Caries; Dental Occlusion, Traumatic; Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Observational

Summary: 
      To evaluate the dental status of children using ritalin and suffering from ADHA in comparison
      to healthy children.
    

Detailed description: 
      In this trial oral and dental status of 30 children (ages 5-12) who suffer from ADHD and
      treated with ritalin will be evaluated. Parameters that will be checked are the following:
      DMFT - decay, missing, filling teeth for dental status, GI - gingival index, PI - plaque
      index for periodontal status. OJ - over jet and OB - over bite for inter-maxillary relations
      and susceptibility for dental trauma. In addition these parameters will be collected for 30
      age and sex match healthy children.
    

Observational model: Case-Control
Sampling method: Probability Sample
Study population: 
        healthy children children with adhd treated with ritalin
      
Keywords: ritalin; ADHA; dental status; periodontal status; Attention-Deficit Hyperactivity Disorder; Dental trauma
Pain Perception and Wound Healing After Laser-assisted Frenectomy in Children
Condition: Frenulum; Hypertrophy
MeSH terms: Hypertrophy
Study type: Interventional

Summary: 
      This study is based on the records of the patients treated for labial frenectomy with a
      dental laser at the Department of Padiatric Dentistry from January 2017 to December 2017.
      Patients younger than 15 years were included and in total 22 patients who matched the
      inclusion criteria were investigated in the study. The analyzed data included age, gender,
      frenelum insertion type, type of dental laser, and postoperative pain perception.
    

Detailed description: 
      This study is based on the records of the patients who received laser-assisted frenectomy
      treatment due to mucogingival problems at pediatric dentistry department during two year
      period. Twenty-two patients treated with either Er,Cr:YSGG laser 2780 nm or 940 nm diode
      laser were selected who fulfilled the study's inclusion criteria. The analyzed data included
      age, gender, frenelum insertion type, type of dental laser, postoperative pain perception and
      wound healing. Post-operative pain was reported with Wong-Baker Faces Pain Rating Scale after
      3 hours 1, 7 and 14 days. Wound surface healing was evaluated through photography. Images
      were uploaded to the software and the changes in the wound area were measured in square
      millimeters at the day of frenectomy and on days 1, 7, and 14 postoperatively.
    

Intervention name(s): Laser-assisted frenectomy with 2780 nm Er:Cr;YSGG and 940 nm diode laser
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
The Use of Music Therapy in the Prevention of Falls
Condition: Accidental Falls; Healthy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to determine whether listening to music will demonstrate changes
      in human postural stability and whether those changes might be useful in fall prevention
      strategies.
    

Detailed description: 
      Falls are a serious health issue and are the greatest cause of death in the elderly. The use
      of music therapy in fall prevention has not been reported in the literature. This
      investigation will provide experimental support to the assumption that music therapy may
      prevent falls and that certain music can affect increases in postural stability using
      randomly selected subjects, validated posturography and a full experimental design.

      Computer dynamic posturography (CDP) tests will provide stability scores in volunteer
      subjects who have had no previous history of falls or vertigo. Subjects will be randomized
      into several different music listening groups and one control group. Examiners will be
      blinded as to the music listened to and the outcome measurements. Subjects will be blinded as
      to their posturographic measurements. The music listening groups will be given a daily
      specific music listening task. CDP tests will be obtained 10 minutes, 1 week and 1 month
      after subject's treatment. Music selection will include Mozart, Nolwenn Leroy and others
      suggested to change human stability.
    

Intervention name(s): Music therapy (listening to specific music)
Intervention type(s): Behavioral
Intervention description(s): Listening to Music
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Fall prevention; posturography; music therapy
Intra-Anally Administered Artesunate in Patients With High-Grade Anal Intraepithelial Neoplasia (AIN 2/3)
Condition: HPV-Related Anal Intraepithelial Neoplasia; AIN2/3; Artesunate; Alternative Treatment; Anal Dysplasia; Precancerous Conditions; Human Papilloma Virus
MeSH terms: Neoplasms; Carcinoma in Situ; Papilloma; Precancerous Conditions
Study type: Interventional
Phase: Phase 1

Summary: 
      This open label study investigates a novel non-surgical approach to the treatment of
      HPV-associated anal intraepithelial neoplasia, using Artesunate suppositories.
    

Detailed description: 
      Patients diagnosed with AIN 2/3 will be enrolled sequentially in treatment cohorts receiving
      different doses of Artesunate suppositories administered trans-anally. Doses of escalation
      will be 200 mg, 400 mg, and 600 mg. Treatment cohorts will consist of 2 or 3 cycles at each
      dose level. Suppositories will be administered daily for 5 days. Five days constitutes 1
      cycle. Up to 3 cycles will be administered at Weeks 0, 2, and 4.
    

Intervention name(s): Artesunate Suppositories
Intervention type(s): Drug
Intervention description(s): Artesunate suppositories for the treatment of (AIN2/3) Anal Intraepithelial Neoplasia
Other intervention name(s): Artemisinin
Intervention MeSH terms: Artesunate; Artemisinins; Artemisinin
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Subjects will be enrolled sequentially in each treatment cohort.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HPV; suppository; Artesunate; artemisinin; anal dysplasia; treatment; alternative treatment; anal precancer; Johns Hopkins; Sandy Fang; Frantz Viral Therapeutics; Wisconsin; Evie Carchman
Pilot Study of Slow Release Oral Milrinone in Patients With Advanced Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Advanced heart failure (HF), ineffective pumping of the heart, is a common, life-threatening
      cardiovascular disorder, characterised by marked symptomatic limitation and frequent
      hospitalization. It is particularly prevalent in older individuals (up to 10% of the
      population) and it has become the most common cause for hospitalization in people >65yrs. As
      such it is also one of the leading consumers of healthcare spending. Recurrent
      hospitalization is frequently due in significant part to the lack of viable therapeutic
      options for severe HF. During hospital admission, medications through a drip to give through
      a vein (intravenous therapy), is required to improve heart pumping capacity (such as
      milrinone).They are frequently used and in many cases prolonged treatment periods of
      intravenous therapy are required. In a growing number of cases, there is a need to continue
      this treatment at home, however this is particularly costly and often complicated by
      intravenous line infection. As such there is an expanding need for therapeutic options in
      patients with advanced HF. Over 20 years ago, studies of the potential utility of a rapid
      release form of oral milrinone were examined, however these studies demonstrated adverse
      effects due to its quick release.

      This study aims to determine the safety and tolerability of slow release oral milrinone in
      advanced HF patients with no further clinical option and to evaluate its effects on HF
      status.
    


Intervention name(s): Milrinone
Intervention type(s): Drug
Intervention description(s): Administration of study medications, PK sampling and safety profile- add on haemodynamic invasive measurements if patient consents to.
Intervention MeSH terms: Milrinone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Global Electrical Heterogeneity and Clinical Outcomes
Condition: Heart Failure; Implantable Defibrillator User; Ventricular Arrythmia
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      This retrospective multicenter cohort will validate an independent association of
      electrocardiographic (ECG) global electrical heterogeneity (GEH) measures with sustained
      ventricular tachyarrhythmias and appropriate ICD therapies in systolic heart failure patients
      with primary prevention ICD, and will validate and re-calibrate GEH ECG risk score for
      prediction of sustained ventricular tachyarrhythmias and appropriate ICD therapies in
      systolic heart failure patients with primary prevention ICD.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        retrospective records of systolic heart failure patients with primary prevention
        ICDs/CRT-Ds implanted for routine clinical indications
Preoperative Analgesia in Non-gynecological Cancerous Women Who Underwent Elective Total Abdominal Hysterectomy
Condition: Total Abdominal Hysterectomy ,Pain , Acute Postoperative,Gabapentin , Celecoxib
MeSH terms: Acute Pain; Pain, Postoperative
Study type: Interventional

Summary: 
      Comparison of effectiveness of preoperative Gabapentin with Celecoxib in reducing acute
      postoperative pain in abdominal hysterectomy, A randomized double blind controlled trial
    

Detailed description: 
      Total abdominal hysterectomy (TAH) is the most common gynecological operation worldwide.Some
      studies noticed about overused of opioids in postoperative care , leaded to more adverse
      effect of opioids , slowly recovery , prolong length of hospitalized stay and consequently
      increase unnecessary cost of treatment.

      ERAS guidelines has considered to use preoperative analgesics for reducing post-operative
      opioids consumption, including Gabapentin and Celecoxib.

      Gabapentin and celecoxib widely used for treatment of pain and many studies have demonstrated
      the preoperative efficacy and safety of Gabapentin and Celecoxib in variety procedures
      involving hysterectomy.However, no definite conclusion of optimal dose and timing for
      preopearive uptake ,apart from no good evidences based supported preoperative Gabapentin or
      Celecoxib in hysterectomy in Thailand . In addition, the protocol for preoperative analgesics
      in hysterectomy, has not been performed in the investigator's center.

      Therefore the aim of this study is to assess and compare the efficacy and safety of
      preoperative Gabapentin and Celecoxib to reduce acute postoperative pain in non-gynecological
      cancerous woman undergoing total abdominal hysterectomy
    

Intervention name(s): Total abdominal hysterectomy
Intervention type(s): Procedure
Intervention description(s): Each drug group undergo elective total abdominal hysterectomy with the same general anesthesia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Ultrasound Assisted Arterial Cannulation in Small Children
Condition: Arterial Cannulation
Study type: Interventional

Summary: 
      Arterial cannulation is a commonly performed invasive procedure in the operation room, the
      emergency department, and in the intensive care unit. The indications include the need for
      continuous blood-pressure monitoring, frequent arterial blood-gas analysis, and repeated
      blood sampling for laboratory evaluation. This procedure can be challenging even in the best
      of hands. Traditionally, the artery is located by feeling the pulse of the patient. The pulse
      may, however be weak or absent in patients with hypotension, edema, obesity or local
      thrombosis due to previous arterial cannulation in the same location. Furthermore, the
      catheter may not be passed successfully into the artery, despite apparent good blood return
      on initial puncture, or hematoma and spasms of the artery may develop after failed attempts,
      thus making further attempts even more difficult. While ultrasound (US) is being used with
      increasing frequency for central venous access, fewer clinicians are familiar with US-guided
      arterial catheterization. The aim of this study is to investigate if ultrasound facilitates
      arterial cannulation in children ≤24 months compared with the palpation method and to
      investigate the potential extra costs/savings of introducing the method. This study
      hypothesizes that the ultrasound method will facilitate arterial cannulation in small
      children compared with the palpation method.
    


Intervention name(s): Ultrasound; Palpation Method
Intervention type(s): Procedure; Procedure
Intervention description(s): Arterial cannulation facilitated by ultrasound.; Arterial cannulation by palpation method.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Arterial Cannulation; Ultrasound; Palpation Method; Pediatrics; Cardiac Surgery; Craniotomies; Cranial Vault Surgery; Abdominal Procedures