bioihbjkbjnl/mcl2 huggingface dataset:
An Open Label, Proof of Concept Study to Evaluate the Effects of Dalfampridine Withdrawal on Gait and Balance Parameters in Subjects With Multiple Sclerosis (MS)
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      The purpose of this study is to determine changes on overall gait as well as in multiple gait
      and balance parameters after withdrawal of dalfampridine-ER 10mg in MS subjects who are
      receiving the medication consistently for at least two weeks prior to screening.
    

Detailed description: 
      Longitudinal study design
    

Intervention name(s): Withdrawal of dalfampridine-ER 10mg
Intervention type(s): Other
Intervention description(s): Withdrawal of dalfampridine-ER 10mg (7 days on study drug followed by withdrawal period of 10 days, followed by on study drug until study completion)
On drug Day-7 (visit 1) through Day 1 (visit 2)
Off drug Day 5±2 days (visit 3) through Day 11±2 days (visit 4)
On drug Day 15±2 days (visit 5)
Other intervention name(s): Ampyra®
Intervention MeSH terms: 4-Aminopyridine
Observational model: Cohort
Sampling method: Non-Probability Sample
Study population: 
        MS Population
      
Keywords: Multiple Sclerosis; MS
Arsha Vidya Program for Preventing Drug Abuse Among Disadvantaged Children in Urban Slums
Condition: Drug Abuse
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      Substance abuse remain critical problems in both developed and developing countries. Under
      privileged communities where health and economic system is weakest, use of drugs and illicit
      substances starts during adolescence and young adulthood. This not just affect physical
      development, mental health and social integration, but also family formation and stability,
      deviant behaviour, sexual behaviour and involvement, educational pursuits, livelihood
      pursuits. Therefore, emphasises the need for preventive education at this impressionable age.
    


Intervention name(s): Arsha Vidya program
Intervention type(s): Behavioral
Intervention description(s): Integrated intervention program includes counselling and supportive care with the support of Arsha Vidya program
Intervention model: Single Group Assignment
Intervention model description: Quasi experimental design
Masking: None (Open Label)
Primary purpose: Prevention
Age-Related Macular Degeneration, Scotopic Dysfunction, and Driving Performance in a Simulator
Condition: Age-related Macular Degeneration
MeSH terms: Macular Degeneration
Study type: Observational

Summary: 
      Previous work collectively suggests that rod-mediated dark adaptation (RMDA) is a promising
      candidate as a functional endpoint measure for evaluating interventions to slow early
      progression of age-related macular degeneration (AMD). However, there is no agreement among
      the clinical, research and regulatory communities as to what constitutes a clinically
      (practically) significant slowing in RMDA. Treatments for AMD are often not considered
      efficacious if they do not result in a criterion level of improvement in vision. But how much
      change in the rate of dark adaptation constitutes a clinically significant change? Until this
      issue is resolved, progress in developing clinical trials on early AMD are at a standstill
      since there is no functional endpoint to be used in the trial. One approach to establishing
      clinical significance is to examine how RMDA relates to the performance of an everyday visual
      task under low luminance conditions, such as night driving or reading. However, such data are
      not yet available. The purpose of this project is to examine the relationship between RMDA
      and night-time driving and reading under poor illumination. This information will guide the
      development of a definition of a clinically significant difference in RMDA that can be used
      in designing clinical trials on early AMD.
    

Detailed description: 
      The specific aims of this study are as follows:

      Aim 1: To examine the association between RMDA as assessed by the rod intercept time and self
      reported driving difficulty and experiences during night time driving.

      Aim 2: To examine the association between RMDA as assessed by rod intercept time and reading
      performance as assessed by the MNREAD test administered under a low light level. Reading
      performance will be defined in terms of maximum reading speed, critical print size (i.e., the
      smallest print size that supports maximum reading speed), reading acuity (i.e., the smallest
      print size that can be just read) and the reading accessibility index (i.e., an individual's
      access to text over the range of print sizes found in everyday life).
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adults living in the community who have current driver's license who have age-related
        macular degeneration
      
Keywords: age-related macular degeneration
Intradermal Influenza Vaccine in the Young
Condition: Influenza Viral Infections
MeSH terms: Influenza, Human; Virus Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      Influenza poses a heavy burden to our health service. The WHO estimates that seasonal
      influenza causes 250,000-500,000 deaths worldwide each year. Various strategies including
      intradermal vaccination and new vaccine adjuvants have been shown to improve immunogenicity.
      Recently, imiquimod, a synthetic Toll-like receptor 7 (TLR7) agonist useful for the treatment
      of DNA virus infection, have been shown to improve vaccine immunogenicity against influenza
      virus in mouse model. The objective of this prospective double-blind randomized controlled
      trial is to evaluate the effect and safety of topical treatment with imiquimod immediately
      before intradermal influenza vaccination in healthy young adults.
    

Detailed description: 
      Influenza poses a heavy burden to our health service. Seasonal, zoonotic and pandemic
      influenza are constant global threats. The WHO estimates that seasonal influenza causes
      250,000-500,000 deaths worldwide each year, with an even higher mortality during the pandemic
      periods. Moreover zoonotic influenza such as the avian-origin H5N1 and more recently the H7N9
      influenza are associated with a much higher mortality than seasonal influenza. Vaccine
      immunogenicity among elderly individuals is also suboptimal due to immunosenescence. Various
      strategies including intradermal vaccination and new vaccine adjuvants have been shown to
      improve immunogenicity.

      Recently, imiquimod, a synthetic Toll-like receptor 7 (TLR7) agonist useful for the treatment
      of DNA virus infection, have been shown to improve vaccine immunogenicity against influenza
      virus in both mouse model. The objective of this prospective double-blind randomized
      controlled trial is to evaluate the effect and safety of topical treatment with imiquimod
      immediately before intradermal influenza vaccination. Our a priori hypothesis is that
      imiquimod pretreatment would expedite and augment the immunogenicity of influenza
      vaccination.
    

Intervention name(s): Imiquimod ointment; Aqueous cream; Intradermal influenza vaccine; Intramuscular influenza vaccine
Intervention type(s): Drug; Drug; Biological; Biological
Intervention description(s): 5% 250mg imiquimod ointment; aqueous cream; intradermal trivalent influenza vaccine (Intanza15); intramuscular trivalent influenza vaccine (Vaxigrip)
Other intervention name(s): Aldara; Aqueous cream BP
Intervention MeSH terms: Imiquimod; Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Study of VIB7734 for the Treatment of Moderate to Severely Active SLE
Condition: Lupus Erythematosus, Systemic
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase 2 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of VIB7734
      for the Treatment of Moderate to Severely Active Systemic Lupus Erythematosus in
      approximately 195 participants. The study duration will be 48 weeks, with a safety follow-up
      through week 56.There will be 3 parallel arms - 2 active treatment and 1 placebo.
    


Intervention name(s): VIB7734; Placebo
Intervention type(s): Drug; Other
Intervention description(s): VIB7734; Placebo
Other intervention name(s): Daxdilimab; HZN-7734
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, placebo-controlled, parallel-arm study
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluation of the Impact of Vitrification on Oocytes
Condition: Fertilization
Study type: Interventional

Summary: 
      The purpose of this study is to determine the rate of cryosurvival of mature oocytes
      following vitrification, and to then compare the reproductive potential of vitrified oocytes
      relative to those which have not been cryopreserved.
    

Detailed description: 
      This study will recruit patients from the NY/NJ/CT/eastern PA area only.

      Cryopreservation of human oocytes has a great potential to preserve or extend fertility in
      the face of disease whose treatment would result in a loss of ovarian function. (malignancy,
      severe autoimmune disease, etc.). It would also provide a means of quarantining oocytes to be
      used in oocyte donation to provide the lowest possible risk of infection.

      There are two methods for storage of oocytes: slow freezing or vitrification. Slow freezing
      is the conventional method and has been successfully used for embryos since 1983 and more
      recently for oocytes. Recent reports indicate that vitrification may be more successful than
      slow freezing. However, the technique has not been rigorously validated to date. The aim of
      this study is to determine the rate of cryosurvival of mature oocytes following
      vitrification, and to then compare the reproductive potential of vitrified oocytes relative
      to those which have not been cryopreserved.

      Patients will undergo ovarian stimulation for in vitro fertilization (IVF) according to the
      protocol recommended by their primary doctor. After retrieval, mature oocytes will be divided
      in half. One half will undergo vitrification, immediate thaw and intracytoplasmic sperm
      injection (ICSI). The other half will undergo just ICSI. All embryos will then develop on
      identical culture until day 3 or day 5. Prior to transfer, the best embryo from each group
      will undergo biopsy for genetic fingerprinting. The patient will have a 2 embryo transfer
      (one from each group). All extra embryos will be biopsied for pre-implantation genetic
      diagnosis (PGD) prior to being cryopreserved. If the patient becomes pregnant, we will follow
      up with an additional blood draw at approximately 9 weeks gestation and buccal swabs after
      the delivery of the infant(s).
    

Intervention name(s): Vitrification and PGD
Intervention type(s): Procedure
Intervention description(s): Half of the oocytes retrieved from each patient will undergo vitrification, immediate thaw and insemination. All embryos will undergo biopsy for PGD prior to transfer.
Other intervention name(s): Vitrification; PGD
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Oocyte; vitrification; IVF; PGD; embryo biopsy
An Interaction Study to Evaluate the Effect of Esomeprazole/Acetylsalicylic Acid on the Metabolism and Effect of Clopidogrel
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to assess whether esomeprazole 20 mg/Acetyl Salicylic
      Acid (ASA) 81 mg affect the metabolism of clopidogrel.
    


Intervention name(s): Clopidogrel; Esomeprazole/ASA
Intervention type(s): Drug; Drug
Intervention description(s): Clopidogrel; 20 mg/81 mg once daily for five days (Day 5-9)
Other intervention name(s): Axanum
Intervention MeSH terms: Esomeprazole; Clopidogrel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: phase 1; cross-over; drug-drug Interaction; esomeprazole; acetylsalicylic acid; clopidogrel; healthy volunteers; cardiovascular disease; patients with acid associated gastrointestinal symptoms
IntelliCycleTM 2.0 Improved Patient-ventilator Asynchrony During PSV
Condition: Automatic Adjustmen of Inspiratory Triger and Cycling-off
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      Pressure Support Ventilation use Expiratory triggering sensitivity (Esense) to transfer
      inspiration to expiration, the value of Esense is fixed. That may lead to asynchrony between
      humans and ventilators, making people uncomfortable and prolonging weaning time.
      Furthermore，trigger delay or inffective trigger happens frequently during insppiratory
      triggering. The ventilators have a compunter drived funcation of automatic adjustmen of
      inspiratory triger and cycling-off based on waveform, IntelliCycleTM 2.0. It will make the
      transforming more synchrony with humans. The objectibe of the present study is to detect the
      effect of automatic adjustmen of inspiratory triger and cycling-off based on waveform on
      patient-ventilator interation.
    

Detailed description: 
      This is a physiological cross-over study. Enrolled patient with different baseline
      respiratory mechanics, for example ARDS patients with low compliance, COPD patient with high
      airway resistance and postoperative patients with almost normal compliance and airway
      resistance. Patients are ventilated with PSV+ Automatic adjustmen of inspiratory triger and
      cycling-off based on waveform, PSV with fixed inspiratory and expiratory and NAVA in two
      different levels of support. The demographic characteristics, diagnosis, formerly medical
      history, Ventilator indications, Ventilator data, other respiratory treatments,
      patient-ventilator interation, work of breathing, Eadi, will be recorded.
    

Intervention name(s): automatic adjustmen of inspiratory triger and cycling-off based on waveform and PSV with fixed Esence
Intervention type(s): Device
Intervention description(s): The ventilators have a compunter drived funcation of automatic adjustmen of inspiratory triger and cycling-off based on waveform, IntelliCycleTM 2.0.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: PSV+ Automatic adjustmen of inspiratory triger and cycling-off based on waveform PSV with fixed inspiratory and expiratory NAVA
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: patient-ventilator interation; automatic adjustmen of inspiratory triger and cycling-off; Neurally controlled PS
Is High Intensity Interval Training Effective to Reduce the Waist Circumference and Fat Percentage at Trunk Region
Condition: Overweight; Physically Inactive; Adults
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Overweight is a risk factor for a number of non-communicable diseases, and this risk doubles,
      if an individual is physically inactive. Various exercise interventional protocols in the
      past have been reported on treating overweight and obesity which helps to decrease the
      different anthropometric variables. Despite all these protocols, obese and overweight do not
      seem to benefit greatly by these exercise training programs, as lack of time is thought to
      the main reason for not engaging in healthful physical exercise. Research evidence has proven
      that people with a body mass index of more than 30 kg/m2 and waist circumference of more than
      102 cm have 2-fold higher risk of waking fewer steps daily. Although physical exercise is
      thought to be very helpful in regulating the body weight, it is very important to identify
      the type of physical activity to effectively manage overweight and obesity. Aerobic exercise
      namely high intensity interval training have been reported to reduce the body mass, fat%, and
      waist circumference. Investigators believe that high intensity interval training would help
      in controlling the various anthropometric variables namely the body mass index, waist
      circumference, and fat% in trunk region in physically inactive overweight adults.
    


Intervention name(s): High Intensity Interval Training
Intervention type(s): Other
Intervention description(s): 4-weeks of high intensity interval training, 3 sessions/week on alternate days. each session for 20 minutes, excluding the warm-up and cool-down.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Stereotactic Body Radiation Therapy (SBRT) in Metastatic Non-small Cell Lung Cancer
Condition: Non-Small-Cell Lung Carcinoma; Liver Cancer; Adrenal Cancer
MeSH terms: Carcinoma, Non-Small-Cell Lung; Adrenal Gland Neoplasms
Study type: Interventional

Summary: 
      This protocol is a single arm phase II multi-center trial evaluating the efficacy of
      Stereotactic Body Radiation Therapy (SBRT) in patients with oligometastatic non-small cell
      lung cancer (NSCLC) with response or stable disease after 4 cycles of first-line
      chemotherapy. The core hypothesis tested is that SBRT after 4 cycles of first-line
      chemotherapy is feasible, safe, provides durable local control of treated lesions and
      improves time to progression compared to historical controls. Patients are eligible for
      enrollment if they have metastatic NSCLC with ≤5 lesions amenable to SBRT.
    


Intervention name(s): stereotactic body radiation therapy
Intervention type(s): Radiation
Intervention description(s): For lung, liver, axial skeleton, and adrenal tumors a dose of either 54 Gy in 3 fxs or 5000 cGy in 5 fx using SBRT techniques
Other intervention name(s): Elekta Bodyframe; Cyberknife
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lung cancer; metastatic; SBRT; Stereotactic body radiation therapy; liver; spine; adrenal; bone cancer; Spinal Column
A Study to Assess the Effect of Ticagrelor in Reducing the Number of Days With Pain in Patients With Sickle Cell Disease
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether ticagrelor is effective in reducing the
      number of days of pain, intensity of pain, and reducing the use of analgesics due to sickle
      cell disease
    

Detailed description: 
      This is a randomised, double-blind, double-dummy, parallel-group, placebo-controlled, study
      evaluating 2 doses of ticagrelor in 90 patients aged 18 to 30 years, with sickle cell disease
      (SCD). Patients will be randomised to double-blind double-dummy treatment period in a 1:1:1
      ratio (30 to each treatment group) to receive ticagrelor 10 mg twice daily (bid), or
      ticagrelor 45 mg bid, or placebo bid to determine the frequency of days with pain using an
      electronic diary (eDiary) every day. Approximately 180 patients will be enrolled. Patient
      will be followed for safety assessment during and after 2 weeks of treatment completion.

      During the 16 week treatment period, patients will complete a daily eDiary concerning daily
      pain intensity, pain location, use of analgesics and absence from school or work. At the end
      of the study patients will be asked to rate the change in their sickle cell pain compared to
      the start of treatment. Platelet aggregation will be measured and reported as P2Y12 reaction
      units (PRU) pre-dose and 2 hours post-dose at week 4 and week 5 after treatment start.
      Pharmacokinetic (PK) parameters will be measured at 2 hours post-dose at week 4, and pre-dose
      and at 2 hours post-dose at week 5. Biomarkers will be assessed pre-dose at week 4, week 5
      and week 8. During the study, patients will be evaluated for adverse events (AEs) including
      bleeding and vaso-occlusive crisis (VOC).
    

Intervention name(s): Ticagrelor; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Two arms: 1) 10 mg ticagrelor + 45 mg ticagrelor placebo or 2) 45 mg ticagrelor + 10 mg ticagrelor placebo. Drugs taken orally, twice a day (morning and evening, at least 12 hours apart) from randomization until the end of treatment.; 10 mg ticagrelor placebo + 45 mg ticagrelor placebo. Drugs taken orally, twice a day (morning and evening at least 12 hours apart) from randomization until the end of treatment
Intervention MeSH terms: Ticagrelor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Sickle cell disease; Young adults; Hestia2; Ticagrelor
Impact of Food on Pharmacokinetics and Pharmacodynamics of Asasantin ER in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Comparative pharmacokinetics and pharmacodynamics of Asasantin ER at fasted and fed state
    


Intervention name(s): Asasantin ER; Standardized breakfast
Intervention type(s): Drug; Other
Intervention MeSH terms: Aspirin, Dipyridamole Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase 1, Open-label, Drug-drug Interaction Study With Octreotide Acetate Injection and Telotristat Etiprate in Healthy Subjects
Condition: Drug Interactions
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the effect of octreotide acetate injections (200 µg 3 times daily [tid]) on the
      pharmacokinetics (PK) of telotristat ethyl and its metabolite LP-778902 relative to
      administration of single-dose telotristat etiprate in healthy male and female subjects
    


Intervention name(s): Telotristat etiprate; Octreotide acetate
Intervention type(s): Drug; Drug
Intervention description(s): 500 mg telotristat etiprate; 200 µg octreotide acetate three times daily
Intervention MeSH terms: Octreotide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment