bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Tissue Flossing on Recovery Time After Intense Physical Exercise Causing Delayed Onset Muscle Soreness
Condition: Health Behavior; Muscle Strain, Lower Leg
MeSH terms: Myalgia
Study type: Interventional

Summary: 
      The aim of the study is to assess whether soft tissue flossing therapy will alleviate
      eccentric muscle-destroying influences. Men aged 20-25 will be tested. Suddenly taking up
      activity in untrained people and performing the fatigue protocol is a heavy burden for the
      body, and its effects may have a negative impact on the body. The assessment of the processes
      taking place in the body under the influence of this type of physical activity with the use
      of soft tissue flossing will broaden the scope of knowledge about this therapeutic method and
      will allow assessing whether it has an impact on accelerating regeneration after intense
      physical exertion.
    


Intervention name(s): soft tissue flossing therapy
Intervention type(s): Procedure
Intervention description(s): BFRT and tissue threading is a therapy that involves applying external pressure below or above a joint or muscle of a selected limb, usually with a circumferential elastic band. The pressure provided by the rolled band securely maintains arterial blood supply but reduces or blocks venous outflow distal to the site.
Other intervention name(s): Blood Flow Restriction Training; BFRT
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study will be conducted in two rounds over 4 weeks. In the first round, subjects will have one leg threaded during the fatigue protocol, and after a four-week rest after full recovery, they will have the other leg threaded during the fatigue protocol.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: health behavior; hamstring flexibility; fascial shearing; delayed onset muscle soreness; muscle disorder; treatment; blood flow restriction training; myotonometer; muscle stiffness
Plasmablast Trafficking and Antibody Response in Influenza Vaccination (SLVP021 2011-2014)
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate the responses to licensed trivalent, inactivated
      influenza vaccine (TIV) delivered by different routes: intramuscular (IM) and intradermal
      (ID) and to the live, attenuated influenza vaccine (LAIV) administered intranasally -- all
      given to generally healthy male and female adult volunteers.
    

Detailed description: 
      The aim of this study is to compare the response to different formulations of licensed
      influenza vaccines.

      The type of seasonal influenza vaccination(s) received independently by volunteers in the
      year(s) since their last study visit will not impact eligibility. Volunteers will be assigned
      into one of three vaccine groups (intramuscular trivalent inactivated influenza vaccine
      (TIV); live attenuated influenza vaccine (LAIV- given year 1 only) or intradermal TIV, based
      on the type of study vaccine they received in 2010, 2011, 2012, or 2013. All participants
      will receive a single dose of their assigned seasonal influenza vaccine. Volunteers will
      complete 3 study visits at Day 0, Day 6-8 and Day 24-32.
    

Intervention name(s): Fluzone® (IM); Fluzone® Intradermal (ID); 2011-2012 FluMist®
Intervention type(s): Biological; Biological; Biological
Intervention description(s): This vaccine is given intramuscularly (IM); This vaccine is given intradermally (ID); This vaccine is given intranasally
Other intervention name(s): Trivalent inactivated influenza vaccine (TIV); FDA-licensed seasonal influenza vaccine; Trivalent inactivated influenza vaccine (TIV); FDA-licensed seasonal Influenza Vaccine; Live, attenuated influenza vaccine (LAIV); FDA-licensed seasonal influenza vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Intramuscular inactivated trivalent influenza vaccine; Intradermal inactivated trivalent influenza vaccine; Live, attenuated influenza vaccine; Young adults
Yinxingmihuan Oral Solution in Treatment of Chest Pain After PCI
Condition: Chronic Stable Angina
MeSH terms: Angina, Stable; Chest Pain
Study type: Interventional

Summary: 
      A prospective, multi-center, double-blind, randomized, placebo-controlled trial is conducted
      to evaluate the efficacy and safety of Yinxingmihuan oral solution in the treatment of chest
      pain after percutaneous coronary intervention (PCI) in patients with stable angina. Patients
      should undergo at least 1-week standardized medical treatment phase before randomization. The
      primary end point is the 12-week angina frequency assessed on the basis of Seattle Angina
      Questionnaire (SAQ) subscales. The main secondary endpoint is the improvement of anxiety
      assessed by Hamilton Anxiety Scale (HAMA) to evaluate its effectiveness for chest pain caused
      by psychological factors.
    


Intervention name(s): Yinxingmihuan oral solution; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Yinxingmihuan oral solution is made of Ginkgo leaf extract and armillariella mellea powders.; The placebo oral solution is in the same appearance, color, smell and taste as the experimental Yinxingmihuan oral solution.
Other intervention name(s): Ginkgo leaf extract and armillariella mellea powders
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
tDCS in MCS: Repeated Stimulations
Condition: Patients in Minimally Conscious State After a Severe Brain Injury (e.g., Anoxia, Traumatic Brain Injury, Stroke)
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Persistent Vegetative State
Study type: Interventional

Summary: 
      In this study researchers will apply transcranial direct current stimulation (tDCS) for 5
      consecutive days in chronic patients in minimally conscious state (MCS).

      2 sessions of 5 days of stimulation will be realized, one anodal and one sham. After each
      stimulation, behavioral improvement will be assessed with the Coma Recovery Scale Revised
      (CRS-R). A final assessment will be done one week after the end of the sessions to assess the
      long term effect of the tDCS.
    

Detailed description: 
      Positive effects of tDCS in patients in MCS was showed in a recent study published in
      Neurology. But the effects went down after 1 or 2 hours. To increase the lasting of the
      effects, a new study will evaluate the effects of tDCS on the left prefrontal dorsolateral
      cortex for 5 consecutive days in chronic patients in MCS.

      2 sessions of 5 days of stimulation will be realized, one session will be real (anodal
      stimulation) and one placebo (sham stimulation). After each stimulation, behavioral
      improvement will be assessed with the Coma Recovery Scale Revised (CRS-R). A final assessment
      will be done one week after the end of the sessions to assess the long term effect of the
      tDCS.

      Researchers expected to see an improvement of the CRS-r total score at the end of the anodal
      session and that this improvement persists for a week.
    

Intervention name(s): transcranial direct current stimulation
Intervention type(s): Device
Intervention description(s): anodal transcranial direct current stimulation on the left dorsolateral prefrontal cortex for the anodal session and sham stimulation (5secondes of tDCS) for the sham session
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: disorders of consciousness; minimally conscious state; traumatic brain injury; stroke; transcranial direct current stimulation
Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK2269557 Administered Via the ELLIPTA Dry Powder Inhaler to Healthy Subjects
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK2269557 is a potent and highly selective inhaled Phosphoinositide 3-Kinase delta inhibitor
      being developed as an anti-inflammatory and anti-infective agent for the treatment of
      inflammatory airway diseases. The study will be conducted at a single centre and in 3 Parts.
      The aim of Part A and B of the study are to assess the safety, tolerability and
      pharmacokinetics (PK) single and repeat doses of a new formulation of GSK2269557 administered
      via the ELLIPTA dry powder inhaler (DPI) to healthy subjects. This is the first study in
      which GSK2269557 will be administered via the ELLIPTA DPI. Part C of the study will
      investigate the proportion of the systemic exposure that post inhalation is due to the
      swallowed fraction of the inhaled dose. Part C will also be conducted using the ELLIPTA
      device and magnesium stearate formulation. Part A will be conducted first. Part B and Part C
      may be run sequentially or in parallel. Part A is a randomized, double blind, placebo
      controlled, single dose, dose escalating incomplete block 2-period crossover study in healthy
      subjects. Subjects will be randomized to receive either one dose strength of GSK2269557 and
      placebo utilizing placebo replacement, or will receive both active dose strengths. Part B is
      a randomized, double blind, placebo controlled, repeat dose study in healthy Subjects.
      Subjects will be randomized to receive either repeat doses of GSK2269557 or placebo for 10
      days. Part C is a, randomized, open-label, crossover design to assess the systemic exposure
      of single doses of GSK2269557 administered via the ELLIPTA DPI to healthy subjects, with and
      without ingestion of activated charcoal. ELLIPTA is the registered trademark of
      GlaxoSmithKline groups of companies.
    


Intervention name(s): GSK2269557 ELLIPTA DPI; Placebo ELLIPTA DPI; Activated charcoal
Intervention type(s): Drug; Drug; Drug
Intervention description(s): GSK2269557 ELLIPTA DPI contains GSK2269557 blended with lactose and magnesium stearate. This will be supplied in two strength of 100 mcg per blister.; Placebo ELLIPTA DPI contains lactose.; The activated charcoal will be supplied by the clinical site. Charcoal will be administered as a suspension of 5 gram activated charcoal in 40 mL of water. The suspension will be made to drunk, in its entirety.
Intervention MeSH terms: Charcoal; Nemiralisib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ELLIPTA; GSK2269557; Tolerability; Safety; Dry powder Inhaler (DPI); Pharmacokinetics
22 Gauge Needle for EUS Guided Tissue Acquisition of Samples for Histologic Examination
Condition: Abdominal Neoplasms
MeSH terms: Abdominal Neoplasms
Study type: Interventional

Summary: 
      To determine the yield of tissue biopsy specimen and the diagnostic accuracy of tissue
      acquisition using a newly developed 22 gauge needle in patients with solid lesions throughout
      the GI tract.
    

Detailed description: 
      The use of 22 gauge needle to gather tissue samples under EUS guidance has not been
      associated with an increased risk, and no major complications have been described so far both
      for the 22 gauge Procore needle and for standard 22 gauge.20, 21 Potential benefits of this
      new needle are the possibility of increasing the chance of retrieving tissue specimens for
      histological examination, with the possibility of increasing the diagnostic accuracy of the
      procedure saving the need and the cost deriving from on-site cytopathology examination. This
      may reduce the need to repeat EUS procedures or other more invasive sampling procedures,
      including surgery.
    

Intervention name(s): Fine Needle Tissue Acquisition
Intervention type(s): Other
Intervention description(s): diagnostic
Other intervention name(s): FNTA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: EUS-guided biopsy
Ertapenem for Initial Empirical Treatment of Third Generation Cephalosporin Resistant Enterobacteriaceae Bacteremia
Condition: Bacteremia; Infection, Bacterial
MeSH terms: Bacteremia; Bacterial Infections
Study type: Observational

Summary: 
      This study aims to assess whether ertapenem as an empiric treatment of
      third-generation-cephalosporin resistant Enterobacteriaceae (3GCRE) bacteremia is
      non-inferior to other carbapenems in term of 30-day mortality.
    

Detailed description: 
      There are limited data of the efficacy of ertapenem as the empiric treatment of serious
      invasive infections, such as bloodstream infections (BSIs), that are due to ESBL-producing
      Enterobacteriaceae. Previous studies of ertapenem were done in small group of patients, in
      less invasive infection, as a definite 'step-down' therapy, or as compared to other
      non-carbapenem antibiotics.
    

Intervention name(s): Ertapenem; Carbapenems
Intervention type(s): Drug; Drug
Intervention description(s): Ertapenem injection; Other carbapenems injection
Intervention MeSH terms: Ertapenem
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients 18 years of age and older admitted to Phramongkutklao Hospital, and Ananda Mahidol
        Hospital with 3GCRE monomicrobial bacteremia will be prospectively identified. In given a
        patient, only the initial episode of 3GCRE monomicrobial bacteremia during the study period
        will be included.
Male Circumcision and HIV Rates in Kenya
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The Luo tribe of Kisumu, Kenya, does not traditionally practice male circumcision (MC). This
      study will work with the Luo tribe to test the effectiveness of MC on reducing the risk of
      HIV infections in young men.
    

Detailed description: 
      Since 1989, numerous epidemiological studies have reported a significant association between
      lack of male circumcision (MC) and risk for HIV infection through heterosexual intercourse.
      These results have led to calls for male circumcision to be considered as an additional HIV
      prevention strategy. However, there is a consensus among the international health community
      that a randomized controlled trial of MC is needed to control for possible confounding
      factors. Additionally, known risks associated with MC need further investigation. This study
      will assess the effectiveness of male circumcision in reducing HIV incidence and will
      evaluate complications of the MC procedure, changes in sexual behavior following
      circumcision, and the biological mechanisms by which the foreskin may increase HIV
      susceptibility. The study will be conducted in Kisumu, Kenya, where the Luo tribe is the main
      ethnic group and less than 10% of adult men are circumcised.

      Uncircumcised men aged 18 to 24 years old will be offered voluntary HIV counseling and
      testing. HIV negative men will be asked to enroll in the study. All study participants will
      be interviewed to obtain socio-demographic information and assess behavioral risk factors.
      Participants will be examined for significant medical conditions. All men will be counseled
      in strategies to reduce their risk for HIV infection. Consenting men will be randomly
      assigned to either the treatment (circumcised) arm or the control (uncircumcised) arm of the
      study. After circumcision, men will be monitored for complications. They will be counseled to
      abstain from sex until healing is complete. Follow-up visits will occur every 6 months for 2
      years. Uncircumcised men will be offered circumcision at the end of follow-up.

      The primary study endpoints will be HIV incidence and surgical complications. Additional
      outcomes will be the incidence of other sexually transmitted diseases and behavioral risks.
      Additional laboratory studies of foreskin tissue will evaluate the number and density of
      specialized cells rich in HIV receptors in order to illuminate the biological mechanisms by
      which presence of foreskin may increase HIV susceptibility.
    

Intervention name(s): male circumcision
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Male circumcision; HIV acquisition; Sexually transmitted infection; HIV Seronegativity
Inhaled Steroid Treatment as Regular Therapy in Early Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      A study of the effect of the early treatment with Pulmicort of newly diagnosed asthma.
      Patients will receive either Pulmicort or a non-active treatment for three years. Neither
      patients or investigators will be aware of the treatment received. After three years of
      treatment all patients will receive Pulmicort for 2 further years.
    


Intervention name(s): budesonide; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Pulmicort
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Asthma; Pulmicort; budesonide
Phase 2b Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group Study to Assess the PD Response and Safety of Three Dose Levels of (PB1023) Injection Following 20 Weeks of Weekly SC Dosing in Adults With T2DM
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary objective:

      The primary objective of this study is to define the dose response of Glymera as measured as
      the change from baseline in hemoglobin A1c (HbA1c) following 20 weeks of once-weekly dosing.

      Secondary objectives:

      The secondary objectives are to:

        -  Describe incidence, severity, and duration of reported gastrointestinal side effects of
           Glymera compared to active comparator;

        -  Compare change from baseline in HbA1c following 20 weeks of dosing compared to placebo
           and active comparator;

        -  Compare change from baseline in fasting plasma glucose (FPG) following 20 weeks of
           dosing compared to placebo and active comparator;

        -  Describe the frequencies of adverse events in the treatment groups; and

        -  Describe the above endpoints for the following subgroups of subjects according to
           baseline type 2 diabetes mellitus (T2DM) therapy: diet and exercise only, metformin
           only, sulfonylurea only, or metformin and sulfonylurea combination therapy.
    


Intervention name(s): 50 mg PB1023; 70 mg PB1023; 100 mg PB1023; Placebo (0.9% Sodium Chloride); Victoza®; Diet and Exercise; Metformin; Sulfonylurea; Metformin and Sulfonylurea
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Other; Drug; Drug; Drug
Other intervention name(s): SC Weekly Injection; daily SC injection
Intervention MeSH terms: Metformin; Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Botulinum Toxin in Patients With Spastic Lower Limb Paresis Associated With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Paresis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Spastic paraparesis is one of the most disabling functional deficits in the population with
      multiple sclerosis between 18 and 80 years of age and at any functional level. Infiltration
      with Botulinum Toxin is a clinical practice that has been carried out for years with clinical
      evidence of improvement in the patient's walking patterns and quality of life. We assume that
      the infiltration of this product can generate a direct benefit in the walking ability of
      these patients and secondarily improve their quality of life.
    


Intervention name(s): Botulinum toxin type A infiltrations
Intervention type(s): Drug
Intervention description(s): Echo-guided infiltration of botulinum toxin type A (Dysport®) in the lower limbs according to normal service practice
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple sclerosis; Botulinum toxin type A
Phase 2 Efficacy, Safety, and Tolerability Study of Natalizumab in Focal Epilepsy
Condition: Epilepsy, Focal Seizures, Partial Seizures
MeSH terms: Epilepsy; Seizures; Epilepsies, Partial
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary efficacy objective of the study is to determine if adjunctive therapy of
      natalizumab 300 mg intravenous (IV) every 4 weeks reduces the frequency of seizures in adult
      participants with drug-resistant focal epilepsy. The secondary efficacy objective is to
      assess the effects of natalizumab versus placebo in drug-resistant focal epilepsy on
      additional measures of seizure frequency.
    


Intervention name(s): Natalizumab; Placebo
Intervention type(s): Drug; Other
Intervention description(s): As specified in the treatment arm.; As specified in treatment arms.
Other intervention name(s): Tysabri
Intervention MeSH terms: Natalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a 6-month randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of natalizumab as adjunctive therapy in the treatment of adult subjects with drug-resistant focal epilepsy. The placebo-controlled phase is followed by a 6-month open-label phase during which all subjects receive natalizumab.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug Resistant Focal Epilepsy, Natalizumab, Seizure