bioihbjkbjnl/mcl2 huggingface dataset:
Observational Study of Iron Overload in Stem Cell Transplantation
Condition: Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; Myelodysplastic Syndrome
MeSH terms: Leukemia; Preleukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic Syndromes; Iron Overload
Study type: Observational

Summary: 
      Recent retrospective studies have suggested that iron overload is a clinically important
      problem in patients undergoing ablative stem cell transplantation. However, these studies
      relied on serum ferritin as a surrogate of iron overload, which limits the conclusions that
      can be drawn from such analyses. Therefore, the investigators are conducting a prospective
      study to more rigorously examine the prevalence, mechanisms, and consequences of iron
      overload in this patient population.
    

Detailed description: 
      As above.
    

Intervention name(s): No Intervention
Intervention type(s): Other
Intervention description(s): There is no intervention on this trial
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patient's who are 18 years or older with acute leukema or MDS underdoing a myeloablative
        allogeneic stem cell transplant
      
Biospecimen description: 
      Banked serum and mononuclear cells
    
Keywords: AML; ALL; MDS; iron overload
Isometric Handgrip Exercise for Blood Pressure Management
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Recent meta-analyses suggest isometric resistance training (IRT) may be superior to aerobic
      exercise for lowering blood pressure. The investigators intend to conduct the largest,
      longest, prospective, double-blind randomized controlled trial using isometric resistance
      training to reduce blood pressure to reduce hypertension.
    

Detailed description: 
      We are looking to assess the effect of isometric exercise on ambulatory blood pressure in
      participants aged 40-70 years who are either pre- or mild hypertensive; either un-medicated
      or taking medication to control their blood pressure. Our secondary aims are to examine
      whether the size of blood pressure change is different in those people taking or not taking
      anti-hypertensive medication, to determine the anti-hypertensive mechanism to IRT, and to
      establish rate of de-training effects after participants have ceased IRT.
    

Intervention name(s): Isometric resistance training
Intervention type(s): Other
Intervention description(s): Isometric handgrip exercise using a hand dynamometer
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Responsible Side Effects Management in Oncology
Condition: Pharmacovigilance; Oncology; Antineoplastic Treatment
MeSH terms: Neoplasms
Study type: Observational

Summary: 
      Study of pharmacovigilance in oncology. Monitoring and management of AEs during
      antineoplastic treatment.
    

Detailed description: 
      Monitoring and management of AE's during antineoplastic treatment. Comparison of AE's
      reported by patient with the ones recognised by the oncologist, and vice versa, during
      antineoplastic treatment.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        all cancer patients actively receiving systemic antineoplastic treatment, ECOG 0-2
      
Keywords: pharmacovigilance in oncology; antineoplastic treatment; adverse events
Efficacy and Tolerability of Levetiracetam Add-On Treatment in Refractory Pediatric Patients With Partial Onset Seizures
Condition: Epilepsy
MeSH terms: Seizures
Study type: Interventional
Phase: Phase 3

Summary: 
      Double-blind, randomized, placebo-controlled, multi-center clinical trial conducted to
      evaluate levetiracetam as adjunctive therapy in children (4-16 years) with refractory partial
      onset seizures.
    


Intervention name(s): Levetiracetam; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): high total tablet weight (HTTW) formulation in tablet strengths of 166.5 mg, 250 mg, and 500 mg was used for patients weighing at least 40.1 kg
low total tablet weight (LTTW) formulation in tablet strengths of 166 mg and 250 mg was used for patients weighing 40 kg or less; Placebo tablets for oral administration that were identical in appearance to the respective formulations (LTTW and HTTW) were used as reference therapy
Intervention MeSH terms: Levetiracetam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Levetiracetam; Keppra
Resistance Training in Patients With Chronic Obstructive Lung Disease (COPD): Whole Body Vibration Versus Conventional Resistance Training
Condition: COPD
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 3

Summary: 
      Pulmonary rehabilitation has been emerged as a recommended standard of care for patients with
      chronic lung disease based on a growing body of scientific evidence. A set of evidence-based
      guidelines were published in American College of Chest Physicians (ACCP) and the American
      Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR). Since then, the
      published literature in pulmonary rehabilitation has increased substantially, and other
      societies have published important statements about pulmonary rehabilitation (eg, the
      American Thoracic Society and the European Respiratory Society).

      In patients with COPD, there is a strong scientific basis for implementing conventional
      resistance training (CRT) in addition to endurance training. Endurance training, such as
      walking, is a key component of pulmonary rehabilitation and improves in exercise tolerance
      and muscular endurance. However, this type of training may not reverse muscle weakness or
      atrophy. For that reason, strength training seems to be the optimum training modality to
      increase muscle mass and strength.

      Recently, Whole-Body-Vibration (WBV) training has been promoted as an alternative for
      resistance training on multigym equipment. In WBV training, the subject stands on a platform
      that generates vertical sinusoidal vibration, during which static and dynamic exercises can
      be performed.

      The present study is conducted to provide an answer on the following question: will a
      resistance training program, such as the whole body vibration, be even effective than a
      conventional resistance training program in patients with COPD.
    


Intervention name(s): Conventional resistance training program; Whole body vibration resistance training program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Conventional resistance training program is followed.; WBV training on FITVIBE
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COPD; Whole Body Vibration training; Conventional resistance training
A 2-Part Study to Investigate the Dose-Ranging Safety and Pharmacokinetics, Followed by the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children ≥ 2 Years Old and Young Adults With Dravet Syndrome
Condition: Dravet Syndrome
MeSH terms: Epilepsies, Myoclonic; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this study is to evaluate the safety, tolerability, and efficacy of
      ZX008 (fenfluramine hydrochloride) when added to adjunctive antiepileptic stiripentol
      treatment in children and young adults with Dravet syndrome.
    

Detailed description: 
      This is a multicenter, 2-cohort trial to first assess the pharmacokinetic and safety profile
      of a single dose of ZX008 (fenfluramine hydrochloride) oral solution when added to a standard
      Dravet syndrome treatment regimen containing valproate (VPA) and clobazam (CLB), with or
      without stiripentol (STP) (Cohort 1), followed by a randomized, double-blind,
      placebo-controlled parallel group evaluation of the efficacy, safety, and tolerability of
      ZX008 as adjunctive therapy for seizures in children and young adults with Dravet syndrome
      (Cohort 2).
    

Intervention name(s): ZX008 (Fenfluramine Hydrochloride); Matching Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ZX008 0.5 mg/kg/day (maximum 20 mg/day). ZX008 drug product is an oral aqueous solution of fenfluramine hydrochloride buffered to pH 5 and provided in concentrations of 2.5 mg/mL.
*Note: The 0.5 mg/kg/day dose of ZX008 fenfluramine hydrochloride in this study is equivalent to 0.4 mg/kg/day (maximum 17 mg/day) dose of fenfluramine base.; Matching Placebo
Intervention MeSH terms: Fenfluramine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Seizure; Tonic clonic; Epilepsy; Myoclonic; Encephalopathy
Virtual Reality (VR) Treatment for Balance Problems in Traumatic Brain Injury (TBI)
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effectivenes of a home-based physical therapy
      program designed to improve balance following traumatic brain injury by incorporating the use
      of a virtual reality system.
    


Intervention name(s): Virtual Reality Based Exercise; Standard Exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A structured, individually tailored, protocol driven, reproducible therapeutic intervention. The study intervention will consist of individually prescribed selections from three off-the-shelf VR games that target the type and severity of balance deficits elicited during the completion of a baseline assessment. Participants randomized to receive this intervention will be assigned a home balance program that utilizes an Xbox Kinect system to provide balance activities.; An individualized home balance exercise program that also targets identified balance system-specific deficits, however, utilizes no VR components.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: traumatic brain injury; balance deficits; virtual reality; home-based therapy
Study Evaluating the Analgesic Efficacy and Safety of ADL5859 in Participants With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effectiveness of ADL5859 in relieving pain
      associated with rheumatoid arthritis (RA) compared with placebo and naproxen (similar to
      Aleve®). A second objective is to see whether the effect of ADL5859 differs after a single
      dose compared with multiple doses.
    

Detailed description: 
      This Phase 2a study was conducted in 2 parts. Part A was a randomized, single-dose,
      double-blind, placebo- and active-controlled, 3-way crossover phase during which participants
      were administered study medication in the clinical facility. Part B was a 14-day, randomized,
      double-blind, placebo-controlled, parallel-group, multiple-dose phase in which participants
      self-administered study medication at home.
    

Intervention name(s): ADL5859; Naproxen; Placebo; ADL5859; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Other intervention name(s): ADL-5859; Naprosyn; Lactose Monohydrate National Formulary (NF); ADL-5859; Lactose Monohydrate NF
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rheumatoid arthritis; arthritis
Osteopathic Manipulative Treatment Effects on High Frequency Parameters in Healthy Subjects
Condition: Healthy Subject; Heart Rate Variability
Study type: Interventional

Summary: 
      The aim of the present study is to determine the extend to which osteopathic manipulative
      treatment (OMT) is effective on a sample of healthy subjects in changing high frequency (HF)
      parameters.
    


Intervention name(s): Osteopathic manipulative treatment; SHAM; CONTROL
Intervention type(s): Other; Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
AcQForce Pulsed Field Ablation-CE
Condition: Atrial Arrhythmia; Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      The Pulsed Field Ablation System Study for Atrial Fibrillation (PFA-AF)
    

Detailed description: 
      This clinical study is designed to evaluate the safety and performance of the PFA System in
      the ablation treatment of atrial fibrillation (AF). Data will be used to support regulatory
      submissions.
    

Intervention name(s): Acutus Medical Pulsed Field Ablation System
Intervention type(s): Device
Intervention description(s): All subjects will be treated using the Acutus Medical Pulsed Field Ablation System (PFA System) to treat their atrial fibrillation.
Intervention model: Single Group Assignment
Intervention model description: The patient population will consist of men and women between the ages of 18 - 80 years, presenting for a de novo ablation for atrial fibrillation.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: atrial fibrillation; ablation; pulsed field ablation (PFA)
A Study Comparing LY900014 to Insulin Lispro (Humalog) in Children and Adolescents With Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      The reason for this study is to compare the study drug LY900014 to insulin lispro (Humalog)
      in children and adolescents with type 1 diabetes (T1D).
    


Intervention name(s): LY900014; Insulin Lispro; Insulin Glargine; Insulin Degludec
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered SC; Administered SC; Administered SC; Administered SC
Other intervention name(s): Ultra-Rapid Lispro; Humalog; LY275585
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Lispro
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: prandial insulin; multiple daily injections; pediatric patients; postmeal dosing
Ocular Changes After Ivermectin - (DOLF IVM/Oncho)
Condition: Onchocerciasis
MeSH terms: Onchocerciasis
Study type: Interventional

Summary: 
      The DOLF Ocular Changes after Ivermectin study will investigate the kinetics of O. volvulus
      microfilaria (Mf) in the eye following treatment with ivermectin. The primary objective is to
      determine the proportion of participants with complete Mf clearance from the eye at 3 and 6
      months following treatment with ivermectin (IVM).
    

Detailed description: 
      This study will examine the kinetics of Mf clearance in the eye following ivermectin
      treatment. Previous studies have been unable to fully assess clearance Mf from the posterior
      chamber of the eye. This study will be the first to use optical coherence tomography (OCT) in
      patients with onchocerciasis to document parasites and pathology in the anterior and
      posterior chambers of the eye, and assess ocular changes following standard ivermectin
      treatment.

      This will be a biomedical prospective cohort study.

      The cohort will be stratified based on Mf levels to achieve approximately the following
      distribution of individuals with roughly one-third of participants in each group.

        1. Individuals with positive skin snip Mf density of ≥ 1 Mf/mg), but no observable Mf in
           eyes using slit lamp and indirect ophthalmoscopy

        2. Individuals with positive skin snip Mf density of ≥ 1 Mf/mg and 1-10 Mf in either eye at
           baseline (based on the highest number counted in either eye)

        3. Individuals with positive skin snip Mf density of ≥ 1 Mf/mg and >10 Mf in either eye at
           baseline.

      All participants recruited into the study will be treated with a single dose of ivermectin
      (150 ug/kg) by mouth under direct observation. This is the standard of care for treatment
      with onchocerciasis.

      Participants will be evaluated following treatment with detailed parasitological and ocular
      examinations 7 days, 3 months and 6 months after treatment.
    

Intervention name(s): Ivermectin 3Mg Tab
Intervention type(s): Drug
Intervention description(s): ivermectin tablet
Intervention MeSH terms: Ivermectin
Intervention model: Single Group Assignment
Intervention model description: Participants are all given a standard treatment (ivermectin) for onchocerciasis.
Masking: None (Open Label)
Primary purpose: Other
Keywords: mass drug administration; ophthalmology
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 14332 CL Powder in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate safety, tolerability and pharmacokinetics, and pharmacodynamics of BI 14332 CL
    


Intervention name(s): BI 14332 CL; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Brain-Based Biomarkers in Response to TMS in MDD
Condition: Major Depressive Disorder; Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Observational

Summary: 
      The overarching goal of this research program is to elucidate causal and directional neural
      network- level abnormalities in depression, and how they are modulated by an
      individually-tailored, circuit-directed intervention. By using concurrent TMS and EEG, the
      investigators can overcome a major limitation of EEG - the inability to demonstrate
      causality. Here, we plan to recruit patients with medication-resistant depression undergoing
      rTMS treatment. At multiple time points, we will perform TMS-EEG to investigate the
      excitability and connectivity profiles of brain networks and how they are modulated during
      treatment. This study aims to provide objective brain network measures that can predict and
      track clinical response to TMS treatment. Findings from this study will be utilized to
      develop a novel, personalized treatment protocol based on individual brain networks.
    

Detailed description: 
      Goals of the study are as follows:

        -  To evaluate the ability to predict and track brain network changes during TMS treatment
           for medication-resistant depression.

        -  To develop quantitative tools that measure the connectivity and excitability of the
           brain using resting and single pulse TMS-EEG.

        -  To determine the feasibility of recording EEG biomarkers in the clinic without
           disrupting clinical care.
    

Intervention name(s): TMS
Intervention type(s): Device
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community care clinic
Performance and Safety of a Second Generation Antimicrobial Graft in Abdominal Position
Condition: Abdominal Aorta Aneurysm
MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
Study type: Interventional

Summary: 
      Safety and performance of an anti-microbial vascular graft in the treatment of aneurysmal and
      occlusive disease of the abdominal aorta.
    

Detailed description: 
      The purpose of this multi center, single arm study is to demonstrate the safety and
      performance of the Second Generation Anti-Microbial (InterGard Synergy) vascular graft in the
      treatment of aneurismal and occlusive diseases of the abdominal aorta.

      The primary endpoint is the assessment of primary and secondary graft patency. The secondary
      endpoints were the assessment of adverse events and the assessment of triclosan and silver
      contents in the serum over the time.
    

Intervention name(s): Intergard Synergy Graft
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Post-marketing Study of Monteplase ("Cleactor") in Patients With Acute Pulmonary Embolism
Condition: Pulmonary Embolism
MeSH terms: Pulmonary Embolism; Embolism
Study type: Interventional
Phase: Phase 4

Summary: 
      To investigate PK and coagulating and fibrinolytic parameter profiles (PD) at the approved
      dose (13,750 - 27,500 IU/kg) in patients with acute pulmonary embolism accompanying
      hemodynamic instability.
    


Intervention name(s): Monteplase
Intervention type(s): Drug
Intervention MeSH terms: Monteplase
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute; pulmonary; embolism; accompanying; hemodynamic; instability
A Study of Carbon-14-Labelled [14C] LY3372689 in Healthy Male Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate how much of the study drug (LY3372689),
      administered as a single dose that has the radioactive substance 14C incorporated into it,
      passes from blood into urine, feces and expired air in healthy male participants. The study
      will also measure how much of the study drug gets into the bloodstream, how its broken down,
      and how long it takes the body to get rid of it. The study will last about 4 weeks. Screening
      is required within 28 days prior to the start of the study and follow up is required
      approximately 7 days after discharge.
    


Intervention name(s): [¹⁴C]-LY3372689
Intervention type(s): Drug
Intervention description(s): Administered orally.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Radiolabeled Drug