bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 2 Study of Cladribine Add-on to Interferon-beta (IFN-beta) Therapy in Multiple Sclerosis (MS) Subjects With Active Disease (ONWARD)
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this study was to evaluate the safety, tolerability and effectiveness of oral
      cladribine when taken in combination with Interferon-beta (IFN-beta) therapy for the
      treatment of multiple sclerosis (MS).

      This study randomized around 200 participants from approximately 50 sites located world-wide,
      who have experienced at least one relapse while taking IFN-beta therapy within 48 weeks prior
      to Screening, irrespective of disability progression. Secondary progressive multiple
      sclerosis (SPMS) participants, who were still experiencing relapses, and participants who
      have received disease modifying drugs (DMDs), other than IFN-beta therapy, during their MS
      treatment history, but were currently on IFN-beta therapy and have experienced active MS
      symptoms (at least 1 relapse) during the 48 weeks prior to Screening, were enrolled.

      Participants were randomized in a 2:1 fashion to receive up to 4 cycles of oral cladribine or
      matching placebo in combination with IFN-beta therapy. Participants who completed the
      double-blind portion of the study were invited to participate in an open-label extension
      phase of matching study design.
    


Intervention name(s): Cladribine; Placebo; Interferon-beta (IFN-beta)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants were administered with cladribine tablets orally as cumulative dose.; Participants were administered with placebo orally.; Participants received IFN-beta therapy (Rebif® new formulation [RNF] 44 microgram [mcg] three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during both DB period of 96 weeks and OL extension period of 48 weeks.
Other intervention name(s): Avonex®; Betaseron®; RNF
Intervention MeSH terms: Interferons; Interferon-beta; Cladribine; Interferon beta-1b
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; Relapsing forms; Interferon-beta therapy
A Study to Evaluate the Efficacy and Safety of Cabergoline Compared With Placebo for the Treatment of RLS
Condition: Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of cabergoline compared with
      placebo on periodic leg movements (PLMS) arousl index and sleep efficiency in patients with
      RLS. Also, additional objective and subjective sleep parameters and quality of life will be
      assessed.
    


Intervention name(s): Cabergoline; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Cabergoline oral tablets administered once daily in the evening: 0.5 mg daily on Days 1 to 3, 1.0 mg daily on Days 4 to 7, 1.5 mg daily on Days 8 to 10, and 2.0 mg daily on Days 11 to 14, followed by a stable dose for an additional 3 weeks; Placebo oral tablets administered daily for 5 weeks
Intervention MeSH terms: Cabergoline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Rasagiline Rescue in Alzheimer's Disease Clinical Trial
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase II, randomized, double blind, placebo controlled, parallel group, proof of
      concept three-site study, to evaluate the effect of Rasagiline in the regional brain
      metabolism on 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG-PET).
    

Detailed description: 
      The study consists of two phases: a 24 week double blind placebo controlled treatment period
      and a 4 week follow up period. Patients will be randomized in a 1: 1 ratio at baseline to
      receive either Rasagiline or matching placebo

      The study drug will be given as 0.5 mg dose once daily for the 4 weeks, then increases to 1
      mg daily for the next 20 weeks. A total of 50 subjects will be enrolled: 25 will receive
      Rasagiline and 25 will receive matching placebo for the 24-week treatment period.

      Primary objective is to determine if exposure to 1 mg of Rasagiline daily is associated with
      improved regional brain metabolism in the treatment group compared to the placebo group in
      Alzheimer's Disease patients
    

Intervention name(s): Rasagiline; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Rasagiline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Improving Motor Function After Spinal Cord Injury
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      The goals of this study are to examine the physiology of Central Nervous System pathways
      contributing to the control of upper and lower extremity movements after SCI, and to promote
      the recovery of extremity movements by using non-invasive brain stimulation and motor
      training.
    

Detailed description: 
      This study will consist of electromyography (surface and intramuscular), peripheral nerve
      stimulation, and transcranial magnetic stimulation, electrical stimulation, of the hand, arm,
      leg, and foot representation of the primary motor cortex, as well as MRI scans of the brain.
      The investigators will examine the physiological measurements of upper and lower extremity
      muscles (such as in the first dorsal interosseous (FDI), biceps brachii (BIC), anterior
      deltoid (AD), tibialis anterior (TA), hamstring (HAMS) and quadriceps (QUAD)). This study may
      occur at the Miami Project to cure Paralysis at the University of Miami. The investigators
      will include subjects between the ages of 18 and 85, both healthy controls and individuals
      with chronic spinal cord injuries that occurred at least 6 months prior to recruitment. Both
      healthy controls and those with spinal cord injuries will be able to perform small hand and
      arm movements and small leg and foot movements. The primary outcome measures of this study
      are muscle responses to stimulation with magnetic pulses using TMS and electrical stimulation
      of a peripheral nerve in the arm or leg. The investigators propose to enhance the recovery of
      motor function by using new protocols of high frequency non-invasive repetitive TMS (rTMS)
      and motor training. Repetitive TMS will be used during hand, arm, leg and foot movements in a
      task-dependent manner to induce cortical plasticity and enhance voluntary output of the
      muscles associated with those movements. Second, rTMS will be applied in a task-dependent
      manner during a visuo-motor training task that also involves movements of the hands, arms,
      legs or feet.
    

Intervention name(s): rTMS; Sham rTMS; Training; Motor Task
Intervention type(s): Device; Device; Other; Other
Intervention description(s): small magnetic pulses will be given to the brain in a non invasive manner.; sham or fake stimulation (TMS or rTMS) will be given to the brain in a non invasive manner; at the direction of the researcher the participant will be instructed to do repetitive motor movements with their arm, hand or leg. this is called training; participants will be asked to perform specific motor tasks or movements with their fingers, hands, arms or legs.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: spinal cord injury; neural control; motor function; hand movement
Safety and Tolerability Study of Oral LGD-6972 for Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      Ligand Pharmaceuticals Incorporated is developing LGD-6972, a novel, orally-bioavailable
      addition to diet and exercise to improve glycemic control in adults with type 2 diabetes
      mellitus. The mechanism of action of LGD-6972 is to reduce the excess liver glucose
      production characteristic of type 2 diabetes mellitus that is a major contributor to
      hyperglycemia. This clinical trial will evaluate the safety and tolerability of escalating
      doses LGD-6972 administered daily over 2 weeks in both healthy subjects and subjects with
      type 2 diabetes mellitus.
    

Detailed description: 
      This is to be a randomized, double-blind, placebo-controlled, sequential, multiple oral dose
      study conducted in normoglycemic healthy subjects (NHS) (Part 1) and subjects with type 2
      diabetes mellitus (T2DM) who are treated with monotherapy metformin (a stable dose at
      randomization) along with diet and exercise (Part 2). Subjects with T2DM who are not on a
      stable dose of metformin but meet all other entry criteria may be enrolled in the study at
      the discretion of the Investigator, but must undergo a stabilization period of at least 12
      weeks before determining eligibility for the study. In Part 1, a single group of healthy
      subjects will be dosed with repeated oral doses of 15 mg of LGD-6972 or placebo once daily
      (QD) for 14 days. In Part 2, a maximum of 3 groups of subjects with T2DM will be dosed with 3
      sequential, increasing doses of LGD-6972 (5 mg, 10 mg or 15 mg) or placebo QD for 14 days.
    

Intervention name(s): LGD-6972; Placebo (Captisol ®)
Intervention type(s): Drug; Drug
Intervention description(s): LGD-6972 sodium salt powder in Captisol ® (betadex [β-cyclodextrin] sulfobutylether sodium, NF); betadex [β-cyclodextrin] sulfobutylether sodium, NF
Other intervention name(s): LGD-6972 sodium oral solution; SBECD
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Precision Approach to PPI Therapy in Gastroesophageal Reflux Disease
Condition: Gastroesophageal Reflux; Laryngopharyngeal Reflux
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic; Laryngopharyngeal Reflux
Study type: Interventional

Summary: 
      This study plans to learn more about reflux associated laryngeal symptoms, and more efficient
      ways to diagnose and treat this condition.
    

Detailed description: 
      Reflux associated laryngeal symptoms, coined "laryngopharyngeal reflux", occurs when
      gastro-esophago-pharyngeal reflux contributes to chronic laryngeal symptoms such as throat
      clearing, sore throat and dysphonia. Over the past 25 years, Reflux associated laryngeal
      symptoms has been increasingly, and often incorrectly, diagnosed and has emerged as a point
      of controversy and confusion.
    

Intervention name(s): Reflux Band® Upper Esophageal Sphincter (UES) Assist Device
Intervention type(s): Diagnostic Test
Intervention description(s): UES augmentation via the UES assist device is effective in true Reflux associated laryngeal symptoms. In our first pilot trial with the UES assist device, patients had significant symptom reduction following 2 weeks of UES assist device use. Based on our preliminary work, we theorize that the UES assist device is effective in Reflux associated laryngeal symptoms.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: esophageal disorders
The OBSTACLE Hypoglycemia Study (MK-0000-158)
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2; Hypoglycemia
Study type: Observational

Summary: 
      This study will assess the correlation between glycemic control and the hypoglycemia symptom
      score in patients with Type 2 diabetes, 12 weeks after addition of a sulfonylurea to an
      ongoing regime of oral hypoglycemic agents.
    

Detailed description: 
      Patients will be evaluated for participation in the study during their usual visit to
      participating diabetes care clinics. Addition of sulfonylurea will be an unbiased decision of
      the participating physicians based on the clinical needs of the participating patients.
    

Intervention name(s): Sulfonylurea
Intervention type(s): Drug
Intervention description(s): The dose and frequency of administration of study drug (sulfonylurea) was decided by the investigator according to the individual need of each participant.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Diabetic clinic patients
Effector and Regulatory T Cell Receptor Repertoire Analyses in Patients Affected by COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Study type: Observational

Summary: 
      The specificity of the adaptive immune response (AIR), and its balance between effector T
      cells (Teffs) and regulatory T cells (Tregs), is most likely a major determinant of the
      outcome of a Covid-19 infection.

      We aim to analyze (i) the cellular components and (ii) the specificity of the AIR to COVID-19
      in 60 patients with moderate and severe form of the disease. This should have important
      implications for (i) understanding the pathophysiology of the disease, (ii) discovering
      biomarkers of severity and (iii) designing treatments and vaccines.
    

Detailed description: 
      The quality of the adaptive immune response (AIR) to COVID-19 probably determines the course
      of the disease. Therefore, a comprehensive knowledge of the immune response to COVID-19 is
      required to better anticipate its outcome and identify vaccine targets. In particular, the
      quality of an AIR can be investigated by immunophenotyping (enumerating immune cells and
      assessing their fitness) and by analyzing the T cell receptor (TCR) repertoire.

      The cellular components of the AIR will be analyzed by a deep immunophenotyping generating
      >800 measures assessing immune cells quantitatively and qualitatively (Pitoiset et al.,2018).
      Combined with supervised and unsupervised analyses, it has the power to detect subtle/hidden
      abnormalities.

      The specificity will be analyzed by studying the global T cell receptor (TCR) repertoire of
      separated Tregs and Teffs from peripheral blood, as well as by single cell sequencing of
      cells from bronchoalveolar lavages.

      These combined approaches should uncover parameters/abnormalities of the AIR linked to the
      infection severity and outcome, and lead to a better understanding of the nature of the Tregs
      and Teffs repertoires against COVID-19. This will have important implications for (i)
      understanding the pathophysiology of the disease, (ii) discovering biomarkers of severity and
      (iii) designing treatments and vaccines.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Men or women, aged 18 to 75, infected with SARS-CoV-2 and admitted to the Pitié-Salpêtrière
        hospital for treatment
      
Keywords: COVID-19; T cell receptor; Effector T cells; Regulatory T cells; Single cell sequencing; Modelisation; Pathophysiology; Biomarkers
Atrial Fibrillation/Sinus Rhythm Before and After Cardioversion
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      This study´s aim is to collect scientific data about patients with atrial inflammation by two
      principles of sensors measuring congestive heart failure.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with atrial fibrillation
Keep It Up! 2.0: A Comparison of Two Online HIV Intervention Programs for Young Men Who Have Sex With Men
Condition: HIV; Gonorrhea; Chlamydia
MeSH terms: Gonorrhea
Study type: Interventional

Summary: 
      Young men who have sex with men (YMSM) account for almost 70% of HIV diagnoses among all
      young people in the U.S. and are alone in facing an increasing rate of infections. Because
      YMSM are less likely to receive relevant sexual health education in traditional settings
      (e.g. schools, community), the Internet is a unique route of reaching and helping YMSM.

      The purpose of this study is to compare two different versions of an online HIV prevention
      program for YMSM. The study is being conducted by researchers at Northwestern University in
      Chicago, Hunter College in New York City, and Emory University in Atlanta. A total of 900
      YMSM will be enrolled into this study from the clinics of community partners in Chicago, New
      York, and Atlanta.

      Participants will be randomly assigned to one of two versions of the program. Some topics in
      the program include HIV facts and myths, sexually transmitted infections (STIs), and condom
      use. All participants, regardless of the program version they receive, will also take at-home
      urine and rectal tests for the STIs chlamydia and gonorrhea. After completing the program,
      participants will be contacted three more times over the course of a year for follow-up
      sessions and surveys.

      The research team hypothesizes that the YMSM-specific prevention program will lead to a
      significant reduction in the frequency of unprotected anal sex acts and new STI infections
      compared to the HIV knowledge program that is for a general audience. The YMSM-specific
      program will also lead to improvements in secondary knowledge, motivation, and skills
      outcomes.

      In order for the research team to measure the effectiveness of the YMSM-specific prevention
      program and determine if the study hypothesis is correct, participants will be asked
      questions about themselves, including questions about their sexual orientation, sexual
      experiences, health practices, including drug use, health knowledge, and questions about
      their feelings and emotions. Based on this information, the research team hopes to later
      change, improve, or expand the program to better address the needs of YMSM.
    


Intervention name(s): Keep It Up!; HIV Knowledge Control
Intervention type(s): Behavioral; Behavioral
Other intervention name(s): KIU!; KIU! 2.0; Keep It Up! 2.0
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Documenting a Learning Curve and Test-retest Reliability of a Virtual Reality Training Simulator in Laparoscopic Surgery
Condition: Education
Study type: Interventional

Summary: 
      The purpose of this study is to determine the learning curve for each of seven tasks in a
      virtual reality laparoscopic simulator by medical students.
    

Detailed description: 
      Developing objective methodology for assessing technical skill is paramount to superior
      surgical training. Alternatives to the traditional apprenticeship model of surgical training
      are necessary in today's emphasis on cost containment and professional competency.

      Metrics are widely employed in virtual environments and provide a yardstick for performance
      measurement. The current method of defining metrics for medical simulation remains more an
      art than a science. Many studies have demonstrated that trainees who practice laparoscopic
      skills in a simulated environment will improve their mastery of those skills when tested in
      that same environment. Fewer studies have been able to document the learning curve for
      mastery of tasks in a virtual reality simulator. This study will investigate the learning
      curve for tasks in a virtual reality laparoscopic simulator.
    

Intervention name(s): LapSim training
Intervention type(s): Other
Intervention description(s): complete curriculum training on LapSim surgical simulator
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Education; Virtual Reality; Laparoscopic Surgery; Learning Curve
A Trial To Assess The Safety, Tolerability, And Immunogenicity Of Rlp2086 Vaccine When Administered In Either 2- Or 3-Dose Regimens In Healthy Subjects Aged ≥11 To <19 Years
Condition: Meningococcal Vaccine
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is to look at a new vaccine that might prevent meningococcal disease, and to look
      at the safety of the new vaccine as well as how well it is tolerated. This study will also
      look at this vaccine being given 2 or 3 times. This study will be done in healthy
      adolescents.
    


Intervention name(s): Vaccine; Vaccine; Vaccine; Vaccine; Vaccine
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): rLP2086 vaccine at visits 1, 2 and 5, saline at visit 3; rLP2086 vaccine at visits 1, 3, and 5, saline at visit 2; rLP2086 vaccine at visits 1, and 5, saline at visits 2 and 3; rLP2086 at visits 1 and 3, saline at visits 2 and 5; rLP2086 at visits 3 and 5, saline at visits 1 and 2
Other intervention name(s): Group 1; Group 2; Group 3; Group 4; Group 5
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Healthy adolescents