bioihbjkbjnl/mcl2 huggingface dataset:
Dose Effect of a Plant Extract on Fatigue
Condition: Mental Energy; Physical Performance
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      Test the short-term effects of the acute consumption of two separate beverages containing
      different concentrations of polyphenols, a beverage containing 75 mg of caffeine and a
      flavored placebo beverage on mental energy and physical performance
    


Intervention name(s): Flavored beverage
Intervention type(s): Other
Intervention description(s): Consume one beverage at the beginning of each visit of the cross-over sequence
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: cognitive; phytochemicals; caffeine; polyphenol; beverage; exercise; mental performance; physical performance; vigilance; vigor; energy; vitality; fatigue; sports performance; high-intensity intermittent exercise
Outcomes After Chiropractic Spinal Manipulative Therapy With Lumbar Disc Herniation and Radiculopathy
Condition: Lumbar Disc Herniation
MeSH terms: Intervertebral Disc Displacement; Radiculopathy; Hernia
Study type: Observational

Summary: 
      In a study that was approved nine years ago (EK-22/2009) we could show (i) that spinal
      manipulative therapy (SMT) is a very effective and safe treatment for acute and chronic
      lumbar disc herniation (LDH); (ii) that SMT is as effective and less expensive than lumbar
      nerve root injections and (iii) that the recurrence rate up to one year was very low in acute
      and in chronic LDH patients. However, the long-term outcome of this conservatively treated
      LDH patients is unknown. Thus, the objective of this amendment is to investigate the
      proportion of long-term recurrences in these patients who were treated with SMT for their LDH
      and to compare these results with already existing data from other treatments, e.g. surgery.
      This is important information to know whether this conservative method is a sustainable
      approach for treating LDH.
    

Detailed description: 
      All 148 patients with magnetic resonance imaging-confirmed disc herniation who were recruited
      for the study EK 22-2009 will be re-contacted to assess the course of their back problem
      during the past approx. nine years using a questionnaire.
    

Intervention name(s): no intervention
Intervention type(s): Other
Intervention description(s): no intervention
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The same patients who were recruited for the study EK-22/2009: Patients with lumbar disc
        herniation that is treated with spinal manipulation
      
Keywords: long-term outcome
Invasive Group A Streptococcus (GAS) Infection in Children: Bacterial Virulence Factors and Detection of Host Immunological and/or Genetic Factors of Predisposition to Infections
Condition: Invasive GAS Infection
MeSH terms: Infections; Communicable Diseases; Disease Susceptibility
Study type: Observational

Summary: 
      The main objective of the study is to characterize the virulence factors of SGA and identify
      immunological and / or genetic factors predisposing to infections in children hospitalized
      with invasive GAS infection.
    

Detailed description: 
      The group A streptococcus (GAS) or Streptococcus pyogenes is a strictly human pathogen ,
      which can cause a wide variety of infections. These range from a simple asymptomatic carriage
      up to 20 % of children , or minor illnesses such as sore throat or impetigo, to severe
      conditions such as necrotizing fasciitis and toxic shock syndrome .

      The pathophysiological mechanisms of invasive GAS infections are poorly understood. These
      mechanisms could involve not only virulence factors of the bacterium ( M protein determines
      the emm genotype , but also super- antigenic exotoxins SpeA , Spe C, Ssa, Sme z or other
      virulence genes , SilC , ... Sic ), but also in some cases, factors associated with host
      immunity in particular in the absence of risk factors for invasive skin infection such as
      cutaneous effraction ( wound , burn , chicken pox ) , corticosteroids or other
      immunosuppressive therapy and recent surgery .

      The investigators assume that in some invasive GAS infections, especially in children without
      risk factors, Mendelian susceptibility to infection may be involved . This hypothesis could
      be tested by studying the molecular characteristics of strains isolated SGA and innate and
      adaptive immunity in children hospitalised for invasive GAS infection with or without
      identified risk factors for infection.

      This study could not only lead to a better understanding of the pathophysiological mechanisms
      of invasive GAS infections but also to detect in children who underwent invasive GAS genetic
      susceptibility to infections requiring specific care . Finally, it could also identify
      specific strains of SGA or molecular profiles, whose detection in practice, lead to a
      suspicion of hereditary immune deficiency.
    

Intervention name(s): DNA samples, GAS strains
Intervention type(s): Genetic
Intervention description(s): DNA samples,GAS strains
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children hospitalized for invasive or non invasive GAS infection
      
Biospecimen description: 
      serum
    
Keywords: Invasive GAS infection; emm genotypes; Bacterial virulence factors; Mendelian susceptibility to infections
Optimizing NIPPV Use for Patients With ALS
Condition: ALS
Study type: Interventional

Summary: 
      This research will examine the utility of the data card recording capacity of nasal
      ventilation devices (NIPPV) in people with ALS to optimize use.
    

Detailed description: 
      The data card records critical features of NIPPV acceptance (hours and timing of use) and
      adherence (apnea/hypopnea index, mask leak, minute ventilation); but to date data card
      monitoring has not yet been incorporated fully into ALS clinic practice. We will limit our
      focus to patients who meet Medicare-reimbursement criteria or AAN-recommended practice
      parameters for initiating NIPPV. The larger question guiding this research is whether data
      card monitoring and communication of these results to clinicians and patient families
      promotes "optimal use" of NIPPV. We define optimal use as (i) high acceptance, as indicated
      by daily night time use greater than 4 hours, and (ii) high adherence, as indicated by
      apnea/hypopnea index, mask leak, and minute ventilation. We will test whether timely
      reporting of acceptance and adherence values to patients and clinicians increases the
      likelihood of (i) changes in orofacial masks and settings on devices and continued use of
      devices, and (ii) positive patient mood and sleep quality and lower caregiver burden over
      follow-up.
    

Intervention name(s): Data Card Report
Intervention type(s): Behavioral
Intervention description(s): Patients received detailed report of acceptance and adherence base don data card information, with linked recommendations, to optimize use.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: ALS; nasal ventilation; data card recording
Phase 1, TAK-648, Single-Rising Dose Study
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety, tolerability and pharmacokinetics of
      TAK-648 when administered as a single oral dose of TAK-648 solution at escalating dose levels
      in healthy participants.
    

Detailed description: 
      This was a phase 1, randomized, double-blind, placebo-controlled, single-center, single-dose
      study in healthy participants. The study is the first TAK-648 study in humans and is designed
      to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of a
      single dose of TAK-648 to healthy participants.

      The compound being tested in this study is TAK-648. TAK-648 is being tested to find a safe
      and well-tolerated single dose.

      This study measured how much of the study drug got into the blood stream and how long it took
      the body to get rid of it. Information about any side effects that may have occurred was also
      collected. This study was a randomized dose-rising study which means that the first group of
      research participants was assigned by chance to receive either the study drug or placebo.
      Placebo is a solution that looks like the study drug but has no active ingredient. The lowest
      dose of the study drug or placebo was given to the 1st group of participants (1st cohort) and
      a higher dose was given to the next group until all the doses of the study drug were tested.
      TAK-648 was dosed in 5 sequential cohorts with escalating doses from the lowest dose given in
      Cohort 1 to higher doses given in the subsequent cohort. Doses could be adjusted based on
      available safety, tolerability, and pharmacokinetic (PK) data.

      Approximately 40 healthy male and female participants were planned for enrollment with 8
      subjects planned (6 randomized to TAK-648 and 2 randomized to placebo) for each cohort. The
      study included 5 cohorts.

      This single-center trial was conducted in the United States. The overall time to participate
      in this study was up to 45 days. Participants made multiple visits to the clinic, including
      one 5-day period of confinement to the clinic. All participants were contacted by telephone
      14 days after the last dose of study drug and on Day 84 (+/-2 days) for a follow-up
      assessment.
    

Intervention name(s): TAK-648; TAK-648 Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TAK-648 Solution; TAK-648 placebo-matching solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug therapy
CellFX System for the Treatment of Cutaneous Non-Genital Warts
Condition: Warts; Warts Hand; Verruca
MeSH terms: Warts
Study type: Interventional

Summary: 
      This prospective, non-randomized, multicenter pivotal study is designed to evaluate the
      safety and effectiveness of the CellFX System in patients with cutaneous non-genital warts on
      all areas of the body, excluding the face.
    

Detailed description: 
      The study will enroll healthy adult subjects with a minimum of two cutaneous non-genital
      warts, excluding the face, with each wart lesion not exceeding 10 x 10mm. One of the warts
      for each subject will be untreated and will serve as the subject's internal control.
      Macrophotography of all study warts will be captured along with Investigator assessments
      using the Wart Measurement Scale (WMS) and lesion measurements for wart reduction. All
      subjects will be followed at 7, 30, 60, 90 and 120-days post-initial CellFX treatment. All
      wart lesions are eligible for re-treatment up to 3 times over the course of the study.
      Adverse events will be documented.
    

Intervention name(s): CellFX Device
Intervention type(s): Device
Intervention description(s): The CellFX System utilizes non-thermal, localized delivery of a timed series of low energy, nanosecond electrical pulses that can trigger regulated cell death.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CellFX; Nano-Pulse Stimulation; NPS; Clearance
Isometric Handgrip Exercise for Blood Pressure Management
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The aim of this project is to conduct a randomised controlled trial to assess the effect of
      performing isometric exercise using a handgrip dynamometer on blood pressure.
    

Detailed description: 
      Recent meta-analyses suggest isometric resistance training (IRT) may be superior to aerobic
      exercise for lowering blood pressure. A randomised controlled study will be conducted with
      participants who are either pre-hypertensive, blood pressure between 120/80 and 140/90, or on
      medication to control their blood pressure. Previous studies have utilised a sedentary
      control so we intend to use a sham group to determine if it can be used as a working control
      for future studies.
    

Intervention name(s): Isometric resistance training
Intervention type(s): Other
Intervention description(s): Isometric exercise using a hand dynamometer.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Safety and Effectiveness of Disposable Pulmonary Surgical Markers in the Localization of Pulmonary Nodules
Condition: Lung Cancer
MeSH terms: Multiple Pulmonary Nodules
Study type: Interventional

Summary: 
      During the VATS procedure, some pulmonary nodules are relatively small or far away from the
      pleura, resulting that they are difficult to be accurately located during the procedure.

      The aim of this study is to evaluate the efficacy and safety of using disposable pulmonary
      surgical markers to localize pulmonary nodules in subjects prior to the resection of
      pulmonary nodules by video-assisted thoracoscopic surgery (VATS).
    

Detailed description: 
      It is a prospective, multicenter, single group target value clinical trial. The subjects will
      undergo VATS within 24h after the placement of the Marker, then the Marker and targeted
      nodule will be removed during VATS. Subjects will be followed up intraoperatively,
      immediately after placement procedure to the end of VATS resection, 7 days after placement
      procedure/before discharge (whichever occurs earlier), and 30 days after Marker placement
      procedure. Demographic and baseline information of subjects, immediate operation success rate
      of marker placement, positioning success rate, and adverse events will be collected and
      recorded in this study.
    

Intervention name(s): Disposable Pulmonary Surgical Marker
Intervention type(s): Device
Intervention description(s): The subjects will undergo Marker placement procedure, within 24h before VATS.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Pulmonary Nodule; Localization; Marker
Binding and Effects of Lu AG06466 in the Brain of Healthy Men
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being done to learn about the binding of Lu AG06466 and its major breakdown
      product (Lu AG06988) in the brain of healthy men having received multiple doses of Lu
      AG06466. As the binding will result in inhibition of an enzyme in the endocannabinoid system
      called monoacylglycerol lipase (MAGL), the effects on this system will be evaluated both in
      the blood and cerebrospinal fluid and compared to the binding in the brain.
    


Intervention name(s): Lu AG06466
Intervention type(s): Drug
Intervention description(s): Lu AG06466 will be administered per dose and schedule specified in the arm description.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of a Low Glycemic Index in Obese Children
Condition: Obesity
Study type: Interventional

Summary: 
      The objective of this study is to compare the effectiveness of a low-GI diet program and a
      standard counseling program in the treatment of obese Thai children.
    

Detailed description: 
      Obese children aged 9-16 years from King Chulalongkorn Memorial Hospital were randomized to
      receive instruction either for a low-GI diet (intervention group) or a low-calorie, low-fat
      diet (control group). Both groups were followed-up every month for six months. The primary
      outcomes were body composition changes during the six-month period, measured by dual X-ray
      absorptiometry (DEXA) and bioelectrical impedance analysis (BIA). Secondary outcomes were
      metabolic syndrome risk changes measured by fasting plasma glucose, insulin, and lipid
      profiles.

      The adherence to the nutritional education and physical activity recommendation was evaluated
      by using three-day dietary records (two weekdays and one weekend day) and a physical activity
      questionnaire at each visit. All participants were examined and counseled about physical
      activity and life style modification strategies by a pediatrician at every visit.
    

Intervention name(s): low calorie/fat diet; Low glycaemic index diet
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Conventional behavioural lifestyle modification instructions x 1/month for 6 months about low-calorie (approximately 1200-1300 kcal/day), low-fat (25% of total calories from fat) and about physical activity (increase non-weight bearing exercise 30 minutes/day at least x 3 times/week, increase physical activity in their routine and decrease sedentary activity).; Experimental behavioural lifestyle modification instructions x 1/month for 6 months about low glycaemic index diet (selection of low-GI carbohydrates with the caloric distribution of carbohydrate 50-55%: protein 15-20%: fat 30-35%, instruction by two-hour small classes with parental participation low GI cooking demonstration and food labeling guidance) and about physical activity (increase non-weight bearing exercise 30 minutes/day at least x 3/week, increase physical activity in their routine and decrease sedentary activity).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Enoxaparin as Treatment for Vulvodynia
Condition: Vulvodynia
MeSH terms: Vulvodynia
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators hypothesize that injections of Low molecular weight heparin (LMWH)
      [enoxaparin] will reduce pain in women with vulvodynia.
    


Intervention name(s): Clexane (enoxaparin)
Intervention type(s): Drug
Intervention description(s): One arm receives enoxoparin, second arm receives saline
Intervention MeSH terms: Enoxaparin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Exploratory Study to Assess the Effect of Fampridine (BIIB041) on Walking Ability and Balance in Participants With Multiple Sclerosis.
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The objectives of this study in Multiple Sclerosis (MS) participants treated with
      prolonged-released fampridine (BIIB041) 10 mg twice daily compared with participants treated
      with placebo are to assess the effect over 24 weeks on the following parameters to explore
      endpoints for the Phase 3 study: self-assessed walking disability, dynamic and static
      balance, subjective impression of well-being, and participants' global impression of change
      in walking . Another purpose of this study is to evaluate the safety and tolerability of
      prolonged-release fampridine.
    

Detailed description: 
      The primary objective of the study is to explore the effect of prolonged-released fampridine
      10 mg twice daily in patients with Multiple Sclerosis with walking disability. The change of
      walking ability will be measured using Multiple Sclerosis Walking Scale-12 (MSWS-12) to
      further elucidate the clinical relevance of changes over 24 weeks treatment duration. Another
      purpose of this study is to evaluate the safety and tolerability of prolonged-release
      fampridine.

      Approximately 120 patients MS will be randomized over 20 sites worldwide. Duration of
      patient's participation in the study will be approximately 28 weeks.
    

Intervention name(s): BIIB041 (PR Fampridine); Placebo
Intervention type(s): Drug; Other
Intervention description(s): 10 mg twice daily, given orally. Doses of study treatment must be spaced at least 12 hours apart. If a dose of study treatment is delayed or missed, the participant should not dose again until their next scheduled dose. Tablets must be swallowed whole and should be taken without food.; Twice daily, given orally. Doses of study treatment must be spaced at least 12 hours apart. If a dose of study treatment is delayed or missed, the participant should not dose again until their next scheduled dose. Tablets must be swallowed whole and should be taken without food.
Other intervention name(s): Fampridine-PR (prolonged-release); Dalfampridine-ER (extended-release); FAMPYRA®; AMPYRA®
Intervention MeSH terms: 4-Aminopyridine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effects of Red Ginseng on Liver Function
Condition: Liver Dysfunction
MeSH terms: Liver Diseases
Study type: Interventional

Summary: 
      Korea Red Ginseng (KRG) has effect on liver function
    

Detailed description: 
      Korea Red Ginseng (KRG) has been known as a natural product with anti-inflammatory effect in
      liver disease. Gut microbiota plays an important roles in the pathophysiology of nonalcoholic
      statohepatitis (NASH). We evaluated the effect of KRG on the pathophysiology of NASH
    

Intervention name(s): Red ginseng
Intervention type(s): Dietary Supplement
Intervention description(s): Red ginseng tablet 120g
Other intervention name(s): Red ginseng tablet
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ginseng; Liver
A Trial of Antenatal Treatment of Alloimmune Thrombocytopenia
Condition: Alloimmune Thrombocytopenia; Fetal Alloimmune Thrombocytopenia
MeSH terms: Thrombocytopenia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purposes of this study are to provide medical management by giving treatment to the
      mother that will bring up the fetal platelet count and to minimize the number of invasive
      procedures to the fetus (which may result in serious fetal injuries).
    


Intervention name(s): IVIG (Intravenous Immunoglobulin); prednisone
Intervention type(s): Drug; Drug
Intervention description(s): one gram per kg of IVIG per infusion given either once or twice; in arm with IVIG 1 gm/kg/wk will also receive prednisone 0.5 mg/kg/day
Intervention MeSH terms: Prednisone; Immunoglobulins; Immunoglobulins, Intravenous; Antibodies; gamma-Globulins; Rho(D) Immune Globulin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomization between 2 groups
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alloimmune thrombocytopenia; Fetal alloimmune thrombocytopenia