bioihbjkbjnl/mcl2 huggingface dataset:
Ajmaline Utilization in the Diagnosis and Treatment of Cardiac Arrhythmias
Condition: Atrial Fibrillation; Tachycardia, Ventricular; Brugada Syndrome
MeSH terms: Atrial Fibrillation; Arrhythmias, Cardiac; Tachycardia; Brugada Syndrome; Tachycardia, Ventricular
Study type: Interventional
Phase: Phase 4

Summary: 
      The study evaluates 3 different populations:

      It is an open, randomized, parallel-group study comparing the effectiveness of intravenous
      (iv) ajmaline with currently used antiarrhythmic drugs in the acute treatment of :

        1. recent-onset atrial fibrillation versus iv flecainide

        2. sustained monomorphous ventricular tachycardia versus iv procainamide

      The study also evaluates in an open, randomized, crossover study, the use of iv ajmaline
      versus iv flecainide in the diagnosis of Brugada syndrome
    


Intervention name(s): flecainide; ajmaline; procainamide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 2 mg/kg iv in 10 minutes; 1 mg/kg iv in 10 minutes; 10 mg/kg iv in 10 minutes
Intervention MeSH terms: Flecainide; Procainamide; Ajmaline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Three-day, In-clinic Evaluation of the BD 2nd Generation Continuous Glucose Sensor Device in Type 1 Diabetics
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the accuracy and performance of a new
      subcutaneous continuous glucose monitor (BD-CGM, Becton Dickinson) in hyperglycemic (high
      blood sugar) and hypoglycemic (low blood sugar) "clamp" conditions and during meal excursions
      over the course of 72 hours as compared to a commercially available monitor.
    

Detailed description: 
      This is a single site, non-randomized study. The study consists of a Screening Visit (Visit
      1) during which the subject will be consented and the inclusion exclusion criteria confirmed.
      An interventional visit (Visit 2)which consists of a 72 hour in-clinic stay and a Follow-up
      Visit (Visit 3). Subjects eligible for the study will be admitted to the clinic for the Study
      Visit 2 in the afternoon on the day before the first Clamp is performed. An IV line for blood
      sampling will be established. One blood sample will be obtained for glucose determination and
      a second blood sample will be collected for immunoassay development before any sensors are
      inserted. Two BD-Glucose Binding Protein-Continuous Glucose Monitor Sensors(BD-GBP-CGM), with
      and without outer layer, and one commercial CGM sensor will be inserted in the subcutaneous
      tissue in the abdomen shortly thereafter. Blood sampling intervals will be adjusted over the
      3 study days as determined by the study event (i.e. clamp period, meal excursion, nighttime).
      During the hyper- /hypo-glycemic clamps periods on Day 1 and Day 3 blood samples will be
      taken more frequently, every 5-10 minutes. During the breakfast meal on Day 2 sampling will
      occur at 10-15 minute intervals for 4 hours to capture the meal excursion. Sampling will be
      less frequent during the evening meal and at night during sleep hours.
    

Intervention name(s): BD CGM with Outer Layer; BD CGM without Outer Layer; Medtronic iPro2 Professional CGM
Intervention type(s): Device; Device; Device
Intervention description(s): continuous (every 2 minutes) subcutaneous glucose monitoring for 72 hours.; continuous (every 2 minutes) subcutaneous glucose monitoring over 72 hours.; continuous subcutaneous glucose monitoring for 72 hours
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Diabetes; Type 1 Diabetes; Continuous glucose monitoring; Blood glucose; Blood glucose sensor; Glucose Binding Protein (GBP)
Homeopathic Treatment of Post-acute COVID-19 Syndrome
Condition: Post-acute Covid-19 Syndrome
MeSH terms: COVID-19; Post-Acute COVID-19 Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine whether an individually prescribed homeopathic medicine has an effect greater
      than a placebo and is a viable treatment option to improve fatigue and quality of life for
      patients suffering from the symptoms of Post-acute COVID-19 Syndrome. The researchers hope to
      achieve this goal by conducting a clinical trial that is scientifically rigorous and
      clinically relevant. Expected results of this pilot study will be to obtain sufficient
      experience and preliminary feasibility data to justify a larger clinical trial of this
      hypothesis.
    

Detailed description: 
      The researchers objectives for the study are to: 1) identify efficient means of recruiting
      subjects, 2) test and refine the initial study design and treatment protocol, 3) evaluate the
      instruments for assessing treatment outcomes, 4) estimate sample sizes that will be required
      in the full-scale trial, 5) determine which homeopathic medicines are most often prescribed
      for this syndrome, and 6) determine whether there is a measurable effect size difference or
      positive trend in reduction of symptoms in patients treated with homeopathy.
    

Intervention name(s): Homeopathic Medication; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Homeopathic medicines are prepared according to standardized methods as specified by the Homeopathic Pharmacopoeia of the United States (HPUS), which was mandated by Congress to regulate the manufacture of homeopathic medicines as part of the Food, Drug, and Cosmetics Act of 1939. All homeopathic medicines prescribed in this study must be found in the HPUS. For a complete list of homeopathic medicines, contact the researchers.; Inert lactose pellets
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, placebo-controlled clinical trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Long Covid
Neurotherapeutics as an Adjunctive Approach to Enhance Exposure Outcomes in Anxiety
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Anxiety disorders are highly prevalent and costly to the individual and society.
      Exposure-based cognitive behavioral therapy (CBT) is the gold-standard intervention for
      anxiety disorders, although this approach does not fully reduce symptoms for all individuals.
      Therefore there is a need for innovative intervention approaches. One approach to augment and
      improve existing therapies would be to enhance the neurocognitive basis of fear extinction
      processes, which are the model on which treatments are based. Enhancing these processes may
      be possible through computerized cognitive training techniques which target executive
      functioning, the cognitive processes that help people manage complex cognitive activities.
      The proposed project is a proof-of-concept pilot study investigating the potential for
      training of executive functioning to improve anxiety-related outcomes. Individuals with
      elevated levels of social anxiety will be randomized to single-session COGnitive Enhancement
      Training (COGENT) or sham training program (ST). All participants will complete a single
      speech session where they present three 7-minute impromptu speeches and rate their anxiety at
      specific intervals. Participants will then complete the COGENT paradigm and affective
      processing task while undergoing fMRI.
    


Intervention name(s): Cognitive Training
Intervention type(s): Behavioral
Intervention description(s): Participants are asked to remember a series of items while solving puzzles.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Improving Retention of Hispanics Receiving Antidepressant Therapy
Condition: Depression; Depressive Disorder
MeSH terms: Depressive Disorder
Study type: Interventional

Summary: 
      This study will develop an intervention that will increase the retention of Hispanics with
      major depression in antidepressant therapy.
    

Detailed description: 
      Despite major advances in the treatment of psychiatric disorders, Hispanics continue to
      underutilize mental health services relative to their own mental health needs. Cultural
      factors are important causes of underutilization. To date, however, attempts to boost
      utilization by improving the cultural congruence of psychiatric services have not focused on
      retaining Hispanics in antidepressant therapy.

      Motivational Interviewing (MI) is a time-limited psychotherapy that has successfully improved
      treatment retention among patients with dually diagnosed substance abuse and psychiatric
      disorders. During Phase I of this study, MI is adapted for use as an adjunctive therapy with
      antidepressant treatment and culturally adapted to Hispanic participants. In Phase II,
      participants receive sertraline for 12 weeks and participate in four sessions of MI therapy
      as a supplementary intervention designed to encourage treatment retention. Participants who
      are intolerant to sertraline or have an inadequate response by Week 6 are switched to
      venlafaxine ER while continuing to receive MI and to complete study assessments. A follow-up
      interview is conducted 6 months after the termination of treatment.
    

Intervention name(s): Sertraline; Venlafaxine Extended Release
Intervention type(s): Drug; Drug
Intervention MeSH terms: Sertraline; Venlafaxine Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hispanic Americans
Enhancing Written Communication in Persons With Aphasia
Condition: Aphasia; Stroke
MeSH terms: Aphasia
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate whether a computerized speech-language treatment
      delivered by a virtual therapist (Oral Reading for Language in Aphasia (ORLA) + Writing)
      results in improved written communication skills of study participants with aphasia (i.e.,
      difficulty with the comprehension and expression of spoken and written language).
    

Detailed description: 
      Stroke is the third leading cause of death and the most common cause of disability in the
      United States. According to the American Stroke Association, the prevalence of stroke in the
      U.S. is approximately 4.8 million with approximately 700,000 additional strokes occurring
      annually. Approximately 150,000 to 250,000 stroke survivors becoming severely and permanently
      disabled each year. A common neurological deficit among stroke survivors, and thus a
      substantial contributor to post-stroke disability, is aphasia. The loss of, or difficulty
      with language is extremely debilitating.

      Adequate written communication skills may be one of the barriers that has prevented
      individuals with aphasia from returning to work. Writing skills are also important for
      participation in social roles, such as household management, civic activities, or
      recreational activities with friends. Individuals with aphasia struggle to compose written
      documents such as personal letters, memos and reports. Furthermore, society's increased
      reliance on written forms of communication including email correspondence, instant messaging,
      texting, Twitter, and social networking sites such as Facebook, exacerbate the challenge that
      individuals with aphasia have in connecting with others, reestablishing and redefining their
      social roles and accomplishing their life-participation goals.

      Computer-directed treatment offers a practical alternative to one-on-one traditional
      treatment provided by a clinician and may be a cost-effective way of extending therapy beyond
      the hospital and clinic to meet the needs of the growing numbers of individuals with chronic
      aphasia and to help them reintegrate into the community and workforce. This project evaluates
      the efficacy of a theoretically-motivated writing program that has been integrated with novel
      computer-based virtual therapy systems and that can be provided intensively to individuals
      with chronic aphasia.
    

Intervention name(s): ORLA; ORLA + Writing
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Practice on ORLA (Oral Reading for Language in Aphasia), a computer-based virtual therapy system.; Treatment includes writing of sentences in combination with ORLA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Aphasia; Stroke; Speech Rehabilitation
Effects of Warm up in Athletes With Previous Hamstring Injury
Condition: Previous Hamstring Injury
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      The objectives of this study is to determine the immediate and 10 minutes follow-up effects
      of a warm-up based on a continous run on a treadmill or the application of a hot-pack in
      athletes with previous hamstring injury. The investigators have as an hypothesis that the
      subjects, after one of this interventions show statistically significant improvements in the
      measurements of pain, flexibility, proprioception and postural control
    


Intervention name(s): Warm Up; Hot Pack
Intervention type(s): Other; Other
Intervention description(s): Run on a treadmill during 10 minutes without fatigue of the participant after this time.; 20 minutes of hot-pack on both hamstring
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two groups. One realize an static warm-up and the other a dynamic warm-up.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Thermotherapy; warm-up; extensibility; pain; athletes
Clinical Study to Assess the Performance of the Dialyzer With Endexo™
Condition: Kidney Failure, Chronic
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic
Study type: Interventional

Summary: 
      Endexo™ is an additive that is blended into the fiber solution during manufacturing of the
      hemodialyzer hollow fibers. The intended purpose of the additive is to increase blood
      compatibility in the finished dialyzer, which is referred to as the "dialyzer with Endexo."
    

Detailed description: 
      This is a prospective, sequential, multi-center, open-label study with subjects on
      thrice-weekly (in-center) hemodialysis (HD). After a Screening Period, there will be 12
      hemodialysis treatments on the Optiflux dialyzer (Optiflux Period), followed by 38 HD
      treatments on the dialyzer with Endexo (Endexo Period), and then a Follow-up Visit. The study
      population will consist of End-Stage Renal Disease ESRD subjects who are a minimum of 22
      years of age. The primary objective of the study is to collect data on the performance of the
      dialyzer with Endexo when used to perform hemodialysis (HD) in End-Stage Renal Disease (ESRD)
      subjects.
    

Intervention name(s): Optiflux and Dialyzer with Endexo
Intervention type(s): Device
Intervention description(s): Hemodialysis (HD) on Optiflux dialyzer from Visit 1 to 12 and followed by HD on the dialyzer with Endexo at visit 13 and continues until visit 50. Dialysis is performed 3 times per week which means the total of the intervention will be 17 weeks.
Intervention model: Sequential Assignment
Intervention model description: 12 HD treatments (4 weeks) with Optiflux dialyzer followed by 38 HD treatments (13 weeks) with Endexo dialyzer
Masking: None (Open Label)
Primary purpose: Treatment
The Impact of the Certified Child Life Specialist on Children's Pain During Immunizations
Condition: Pain
Study type: Interventional

Summary: 
      The purpose of this study is to provide the first systematic evidence that Certified Child
      Life Specialists reduce pain during vaccine administration and improve caregiver visit
      satisfaction in the pediatric primary care setting.
    


Intervention name(s): Certified Child Life Specialist Support
Intervention type(s): Other
Intervention description(s): Provides psychosocial care to children and families confronting stressful and painful situations
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Interprofessional Management of Chronic Back Pain in Rural and Remote Setting: Use of Telehealth vs. Secure Laptop-based Videoconferencing
Condition: Back Pain Lower Back Chronic
MeSH terms: Back Pain
Study type: Interventional

Summary: 
      This pilot study will evaluate the impact and overall experience of an interprofessional
      chronic low back pain patient care approach for people in rural and remote areas using
      Telehealth technology compared to secure laptop based videoconferencing (Vidyo).
    

Detailed description: 
      People with chronic low back pain will be recruited to participate in a team assessment with
      a local rural nurse practitioner and an-urban based physiotherapist linking through
      telehealth. The assessment will include a detailed history, physical examination and
      jointly-delivered education and recommendations for further community-based management. Pre
      and post measures of self-reported pain, back-specific function, quality of life, and
      satisfaction will be completed 2-4 weeks after the assessment. Comparison of short-term
      outcomes will be made with a group of participants from another study using the a different
      telehealth technology (secure laptop based videoconferencing) same inclusion criteria,
      measures and health care providers (Clin Trials.gov NCT02225535). The health care providers
      will be interviewed to get feedback on their preference and experience using the different
      type of telehealth technology.
    

Intervention name(s): interprofessional back pain assessment
Intervention type(s): Other
Intervention description(s): team assessment and education with urban physical therapist and rural nurse practitioner via telehealth
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: rural health; telehealth; physiotherapy; interprofessional
Effects of Different Concentrations of Pressurized-heparin Flushing Fluid on Coagulation and Platelet Function Monitored by the Sonoclot Analyzer
Condition: Heparin; Perioperative
MeSH terms: Flushing
Study type: Interventional

Summary: 
      Heparin diluent or normal saline is generally used as the arterial tube flushing in clinical
      practice, but there is no consensus on the choice of flushing fluid. Heparin can affect the
      blood coagulation function, and even lead to heparin-related thrombocytopenia, increasing the
      risk of perioperative embolism. Sonoclot is a blood viscoelasticity test, which can provide
      comprehensive information on the coagulation's cascade and the entire process and be quicker
      and more effective than routine laboratory coagulation tests. In this research, the
      coagulation and platelet function analyzer called Sonoclot is used to evaluate the effect of
      different concentrations of pressurized heparin on the coagulation and platelet function of
      perioperative patients, which can provide a reference for the clinical choice of appropriate
      arterial flushing.
    


Intervention name(s): Heparin; Heparin; normal saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): heparin with a concentration of 2 U/ml is used for pressurized continuous flushing of the invasive arterial pressure monitoring tube; heparin with a concentration of 4 U/ml is used for pressurized continuous flushing of the invasive arterial pressure monitoring tube; normal saline is used for pressurized continuous flushing of the invasive arterial pressure monitoring tube
Intervention MeSH terms: Heparin; Calcium heparin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
PET Study to Determine Muscarinic Receptor Occupancy in Lungs After Inhalation of AZD2115 and Tiotropium
Condition: Healthy Volunteers
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 1

Summary: 
      An open-label study using positionemissiontomography (PET) to explore the binding of AZD2115
      and Tiotropium to muscarinic receptors in the lungs in healthy volunteers after inhalation.
    

Detailed description: 
      A phase I open-label exploratory study in healthy male volunteers using
      positionemissiontomography (PET). The study will test the hypothesis that Tiotropium and
      AZD2115 binds to the mAchRs in a saturable manner and aims to examine the relationship
      between receptor occupancy and drug exposure.
    

Intervention name(s): AZD2115; SPIRIVA; [11C]AZ13754366
Intervention type(s): Drug; Drug; Radiation
Intervention description(s): AZD2115; Tiotropium; Radioligand
Intervention MeSH terms: Tiotropium Bromide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy volunteer study
Positive Angle Kappa
Condition: Aniridia
MeSH terms: Aniridia
Study type: Observational

Summary: 
      Patients with aniridia have positive angle kappas.
    


Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        patients with aniridia
      
Keywords: aniridia; positive angle kappa
Effects of Once and Twice Daily Dosing Regimen of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes (MK-8835-040)
Condition: Diabetes Mellitus, Type 2; Adult
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 randomized, double-blind, sponsor open, 4 arm, 2 way cross-over study using
      2 cohorts. The objective of the study is to evaluate the pharmacodynamics (PD) effects and
      the pharmacokinetic (PK) of single day dosing of 2 mg and 4 mg doses of ertugliflozin (Ertu,
      PF-04971729/MK-8835) each administered once vs twice daily (morning [AM] and evening [PM]) in
      adults with type 2 diabetes.
    


Intervention name(s): Ertugliflozin 2 mg single dose; Ertugliflozin 2 mg split into twice daily; Ertugliflozin 4 mg single dose; Ertugliflozin 4 mg split into twice daily; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Ertugliflozin 2 mg dose (two 1 mg strength tablets), administered as a single dose; Ertugliflozin 1 mg dose (1 mg strength tablet) administered twice daily x 1 day; Ertugliflozin 4 mg dose (four 1 mg strength tablets), administered as a single dose; Ertugliflozin 2 mg dose (two 1 mg strength tablets) administered twice daily x 1 day; Placebo to ertugliflozin administered as a single dose
Intervention MeSH terms: Ertugliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other