bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Green Tea as Antioxidant Agent in Management of Oral Lichen Planus
Condition: Oral Lichen Planus
MeSH terms: Lichen Planus, Oral; Lichen Planus
Study type: Interventional
Phase: Phase 3

Summary: 
      The study included forty individuals divided into 3 groups. 10 control subjects, 15 oral
      lichen planus (OLP) patients who were treated with topical corticosteroids and 15 oral lichen
      planus (OLP) patients who were treated with topical corticosteroids and green tea tablets.
    

Detailed description: 
      This study included forty individuals divided into 3 groups. Group A; 10 systemically healthy
      control subjects not receiving medication.

      Group B; 15 Patients who were previously diagnosed with OLP presented in acute exacerbation
      were treated with topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase:
      Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at
      bed time for one month.

      Group C; 15 Patients who were previously diagnosed with OLP presented in acute exacerbation
      were treated with both topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase:
      Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at
      bed time for one month in addition to green tea tablets 200 mg (Green tea extract 5:1, El
      Obour For Modern Pharmaceutical Industries) as one tablet a day also for one month.
    

Intervention name(s): green tea tablets (Green tea extract 5:1) 200 mg; Triamcinolone Acetonide
Intervention type(s): Drug; Drug
Intervention description(s): Green tea is a product made from the Camellia sinensis plant. The fresh leaves are used to make medicine. the green tea extract is presented in a form of tablets 200 mg and is taken orally.; topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month
Other intervention name(s): Green Tea Polyphenolic Fraction; Kenalog in orabase
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Pilot Study Using Propranolol To Promote Prenylation Of Gtpase Rap1b In Hematopoietic Stem Cell Transplant Recipients
Condition: Hematopoietic Stem Cell Transplantation
Study type: Observational

Summary: 
      This is a an ancillary study designed to explore whether an additional cell signaling pathway
      (prenylation of Rap1) that was recently identified as being under beta-adrenergic control may
      be affected by beta-blocker use.
    

Detailed description: 
      This is a proof of concept randomized controlled pilot study assessing whether prenylation
      and membrane localization of Rap1 in PBMCs can be altered in individuals undergoing
      autologous Hematopoietic Cell Transplant (HCT) for Multiple Myeloma by administering a daily
      beta-blocker (propranolol) to 20 participants. Outcomes of patients on this clinical trial
      will be compared to 20 participants in a control arm.
    

Intervention name(s): Blood Draw
Intervention type(s): Other
Intervention description(s): Lab will draw one tube of blood to be stored in 8 mL Becton Dickinson (BD) Vacutainer Cell Preparation Tube (CPT) tubes at three study time points as described in Table 4.7b. These time points include baseline, Day -2 (immediately prior to transplant, central line placement, or administration of any conditioning regimen), and Day +28.
Peripheral blood mononuclear cells (PBMCs) will be isolated from the whole blood samples collected from patients at the three designated time points (Baseline, Day -2, and Day +28). The lab will conduct western blotting on the cytosolic and membrane fractions of isolated PBMCs to determine the distribution of Rap1 in the different fractions, and the status of Rap1 prenylation in the cells.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who are enrolled in the parent study (NCT02420223) are eligible for this ancillary
        study.
      
Biospecimen description: 
      Peripheral blood mononuclear cells (PBMCs) will be isolated from the whole blood samples
      collected from patients at the three designated time points (Baseline, Day -2, and Day +28).
      Members of Dr. Carol Williams' laboratory (Professor, Pharmacology and Toxicology, MCW) will
      conduct western blotting on the cytosolic and membrane fractions of isolated PBMCs to
      determine the distribution of Rap1 in the different fractions, and the status of Rap1
      prenylation in the cells.
A Phase 1 Study to Evaluate the Safety and Tolerability of GSK1362885 in Healthy Normal Subjects
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will investigate whether GSK1362885 is safe and well-tolerated when administered to
      normal healthy subjects. The study will also measure blood levels of the study drug to
      determine how the body processes the drug (pharmacokinetics) and what effects the drug has on
      the body (pharmacodynamics).
    

Detailed description: 
      GSK1362885 is a glycogen phosphorylase inhibitor that is targeted as a treatment for Type 2
      Diabetes Mellitus by reducing hepatic glucose output. This study will investigate the safety,
      tolerability, pharmacokinetics, and pharmacodynamics when single doses of GSK1362885 are
      administered to healthy volunteers. A glucagon challenge test will be used to stimulate
      hepatic glucose output in order to evaluate liver glycogen phosphorylase inhibition by
      GSK1362885.
    

Intervention name(s): GSK1362885; GSK1362885; Glucagon; Glucagon + GSK1362885
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 5 - 100mg of GSK1362885 or placebo; 100 - 600mg or placebo; 0.5mg IV bolus; 0.5mg Glucagon IV bolus + selected dose of GSK1362885
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: FTIH; Glucagon; Safety; GSK1362885; Pharmacokinetics; Tolerability; Pharmacodynamics
A First-in-human, Single Ascending Dose Study of GZ402668 in Patients With Progressive Multiple Sclerosis
Condition: Progressive Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To assess the safety and tolerability of GZ402668 after ascending single intravenous (IV) and
      subcutaneous (SC) doses in men and women with progressive multiple sclerosis.

      Secondary Objectives:

      To assess the following in men and women with progressive multiple sclerosis:

        -  The pharmacokinetic (PK) parameters of GZ402668 after ascending single IV doses.

        -  The pharmacodynamics (PD) of GZ402668 after ascending single IV doses.

        -  The PK parameters of GZ402668 after ascending single SC doses.

        -  The PD of GZ402668 after ascending single SC doses.
    

Detailed description: 
      The total study duration from screening for a patient can be approximately up to 8 weeks.

      Upon completion of this trial, patients treated with GZ402668 will be required to enroll in a
      4 year safety follow-up study for continued safety observation.
    

Intervention name(s): GZ402668; placebo; GZ402668; placebo; acyclovir
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Pharmaceutical form:solution Route of administration: intravenous; Pharmaceutical form:solution Route of administration: intravenous; Pharmaceutical form:solution Route of administration: subcutaneous; Pharmaceutical form:solution Route of administration: subcutaneous; Pharmaceutical form:tablet Route of administration: oral
Intervention MeSH terms: Acyclovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Functional Electrical Stimulation (FES) Driven Stepping in Individuals With Spinal Cord Injury
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The research is being done to find out if Functional Electrical Stimulation (FES) stepping
      can improve the function of people with spinal cord injury that paralyzes.
    

Detailed description: 
      Muscles to cause the weakened or paralyzed muscles to contract and produce a stepping motion
      of the legs. The FES stepping in this study will be done through a device called the RT600
      FES Stepper (RT600).
    

Intervention name(s): FES Stepping (RT600 from Restorative Therapies, INC.)
Intervention type(s): Device
Intervention description(s): You will be transferred to the RT600 device and secured in a support harness. We will place your legs onto the RT600 device and secure them with straps. Electrodes (pads that stick to the skin) will be placed on your skin on your legs, buttock, stomach, and back. The pads will be connected to a stimulator box through a wire. We will then start the stepping motor and stimulate your muscles with electric current. This will cause your legs to step. You will do this for 1 hour.
Other intervention name(s): RT600 from Restorative Therapies, INC.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Spinal Cord Injury; Functional electrical stimulation; Rehabilitation
The Incidence of Gingival Fissures _ a Crossover Single-blinded Randomized Clinical Trial
Condition: Gingival Recession; Wounds and Injuries
MeSH terms: Gingival Recession; Wounds and Injuries
Study type: Interventional

Summary: 
      The objective of this study is to evaluate the incidence of gingival fissures according to
      the type of brush used, soft and medium.
    

Detailed description: 
      Gingival recession constitute a functional and aesthetic problem that affects much of the
      population. One of the possible causes refers to a traumatic brushing. Individuals who have
      an excessive tooth brushing can cause injuries to your gums, such as abrasions and fissures.
      These lesions have been considered subrogated outcomes of gingival recession noninfectious.
      The literature only reports and case series showing the gingival fissures, which were once
      associated with traumatic occlusion.

      This is the first clinical trial to evaluate the gingival fissures according to the type of
      brush used.
    

Intervention name(s): Toothbrush type
Intervention type(s): Device
Intervention description(s): Evaluate the use of toothbrushes with bristles soft and medium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: Toothbrushing; gingival recession
Resistance Training and Milk Supplementation
Condition: Muscular Hypertrophy
MeSH terms: Hypertrophy
Study type: Interventional

Summary: 
      Post-resistance training high protein milk supplementation may be a viable method to elicit
      muscular gains.

      The investigators hypothesis is that high protein milk supplementation would improve skeletal
      regulatory markers, hormonal responses and body composition in resistance-trained men.
    

Detailed description: 
      The aim of this investigation was to compare the effects of high protein milk supplementation
      (daily and after training sessions) during 6 weeks of resistance training on skeletal muscle
      regulatory markers, hormonal responses and body composition in resistance-trained men.
      Specific aims of the study are to:

      To investigate the extent to which high protein milk supplementation will improve anabolic
      factors, lean body mass, fat mass and decrease catabolic markers after 6 weeks of resistance
      training in resistance-trained men.
    

Intervention name(s): high protein milk; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): This intervention consisted of high protein milk consumption concomitant with 6 weeks of resistance training. Subject ingested consumed 1 x 250 mL immediately after resistance training and 1 x 250 mL half an hour before bedtime.; This intervention consisted of the consumption of a maltodextrin drink with a 9% solution with a vanilla flavor concomitant with 6 weeks of resistance training. Subject ingested consumed 1 x 250 mL immediately after resistance training and 1 x 250 mL half an hour before bedtime.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Hypertrophy; body composition; milk; resistance training
Examine the Possible Association of Hepatic CYP3A Activity and the Susceptibility to Femur Head Necrosis
Condition: Femur Head Necrosis
MeSH terms: Femur Head Necrosis; Necrosis
Study type: Observational

Summary: 
      The purpose of the present study was to examine the possible association of hepatic CYP3A
      activity and the susceptibility to femur head necrosis in patients treated with
      corticosteroids.
    

Detailed description: 
      Femur head necrosis is one of the major side effects of corticosteroid therapy. Since
      corticosteroids are metabolized by hepatic cytochrome P-450 (CYP) 3A, a low endogenous
      activity of this enzyme may contribute to the pathogenesis of ONFH. The purpose of the
      present study was to examine the possible association of hepatic CYP3A activity and the
      susceptibility to femur head necrosis in patients treated with corticosteroids.
    

Observational model: Defined Population
Time perspective: Other
Keywords: Femur Head Necrosis; CYP3A
Studying Nicotine Addiction With Transcranial Magnetic Stimulation
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Observational

Summary: 
      Background:

      - Nicotine addiction often makes it difficult to stop smoking. Researchers want to understand
      the areas of the brain that are important in nicotine addiction. They will use a type of
      brain stimulation called repetitive transcranial magnetic stimulation (rTMS) to look at part
      of the brain that may be involved in nicotine addiction. They will see how these areas affect
      brain function, thinking, and decision making. For this study, rTMS will first be tested on
      nonsmokers, then smokers will be recruited at a later time.

      Objectives:

      - To study areas of the brain involved in nicotine addiction.

      Eligibility:

      - Individuals at least 18 years of age who do not smoke.

      Design:

        -  Participants will be screened with a physical exam and medical history. They will also
           provide a urine sample.

        -  There will be four study sessions. The first session will involve a magnetic resonance
           imaging (MRI) scan. The other three visits will involve rTMS and MRI scans.

        -  The first MRI scan will take a baseline picture of the brain. Participants will also
           practice the tasks for the other three sessions in a mock scanner.

        -  At the next three visits, participants will have rTMS and MRI scans. Two visits will
           involve rTMS; the other visit will involve mock rTMS with no actual magnetic
           stimulation. During the MRI scans, participants will perform tasks that involve decision
           making.
    

Detailed description: 
      Objective: To investigate the neurocircuitry cognitive and affective processing relevant to
      nicotine addiction using repetitive Transcranial Magnetic Stimulation (rTMS). Specifically,
      we will examine insula neurocircuitry using a unilateral H-coil to deliver rTMS to the Right
      dorsolateral prefrontal cortex (R DLPFC) and insula. We will examine the effect of various
      stimulation parameters on behavior as well as on task based activation and resting state
      functional connectivity (rsFC) during fMRI scanning.

      Study population: Up to 60 healthy adults who are non-smokers will be enrolled to achieve 28
      completers.

      Design: Within subject design with each subject completing 4 sessions: rTMS at two different
      stimulation frequencies and 2 sham sessions.

      Outcome measures: Behavior on a decision making task and task based and resting state blood
      oxygen level-dependent (BOLD) activation in neural circuits relevant to nicotine addiction
      during fMRI scanning.
    

Time perspective: Retrospective
Keywords: Functional Magnetic Resonance Imaging (fMRI); Nicotine; Repetitive TMS (rTMS); fMRI
Folic Acid Supplementation in Phenytoin Induced Gingival Overgrowth
Condition: Gingival Overgrowth
MeSH terms: Gingival Overgrowth
Study type: Interventional
Phase: Phase 3

Summary: 
      Phenytoin, a common anti-seizure drug, leads to cosmetically unacceptable side effect of
      gingival overgrowth in a significant number of patients. There is some evidence of
      therapeutic effect of folic acid in cases of established phenytoin induced gingival
      overgrowth. In this study, the aim is to study the prospective preventive effect of low dose
      oral folic acid supplementation on phenytoin induced gingival overgrowth in epileptic
      children.
    


Intervention name(s): folic acid; placebo
Intervention type(s): Drug; Drug
Intervention description(s): capsule 0.5 mg once a day; capsule, once a day
Intervention MeSH terms: Folic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: phenytoin; gum hyperplasia; phenytoin induced gingival overgrowth; plaque index; gingival overgrowth grade
IMPAACT P1080: Psychiatric and Antiretroviral Medication Concentrations in HIV-infected and Uninfected Children and Adolescents
Condition: ADHD; HIV
Study type: Observational

Summary: 
      The main purpose of this study is to find out how stimulant medications (methylphenidate or
      amphetamine/ dextroamphetamine) for the treatment of Attention Deficit Hyperactivity Disorder
      (ADHD)are processed in HIV-1 infected and HIV-uninfected children and adolescents.
    

Detailed description: 
      P1080 is a pilot population pharmacokinetic study of HIV-1 infected and uninfected children
      and adolescents who are taking methylphenidate or amphetamine/ dextroamphetamine for the
      treatment of ADHD. Prescribing various psychiatric medications in combination with
      antiretroviral regimens is a standard clinical practice occurring without adequate evidence
      regarding benefits and risks. The goals of this study are to determine plasma concentrations
      of psychiatric and antiretroviral medications in children and adolescents. Psychiatric
      medication dose requirement and exposure in HIV-1 infected subjects will be compared to that
      seen in uninfected children and adolescents, and antiretroviral exposure will be compared to
      published studies in children and adolescents.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        HIV-1 infected and uninfected children and adolescents ages ≥6 to <25 years who are
        currently receiving methylphenidate or amphetamine/dextroamphetamine for treatment of
        attention deficit hyperactivity disorder (ADHD)
      
Biospecimen description: 
      Non-viable PBMC pellets for DNA genotypic analysis
    
Keywords: ADHD; HIV; Pharmacokinetics
Assessing Fermentability of a Dietary Fiber
Condition: Nutritional Intervention
Study type: Interventional

Summary: 
      The objective of this study is to provide evidence for its fermentability of a dietary fiber
      and to collect information regarding potential health opportunities for glucose control as
      well as tolerability when being consumed over 7 days.
    

Detailed description: 
      This study is designed as a randomized, 2-arm, treatment-controlled, within-subjects, 8-hour
      postprandial crossover study, utilizing a multiple sampling paradigm to evaluate
      fermentability and potential health opportunities for glucose control of a dietary fiber
      (FCHO) in healthy non-obese men and women. The study will include 2 - 8 h assessments
      following consumption of the FCHO drink or a placebo drink and will follow with a 7 day
      feeding period to assess tolerability.
    

Intervention name(s): A dietary fiber (FCHO); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 15 g twice per day in beverage; Placebo drink
Other intervention name(s): FCHO; PCB
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Dietary Fiber; Blood glucose control; Fermentability; Tolerability
Safety & Tolerability Study That Compares Restylane to Restylane With Lidocaine While Correcting Wrinkles in the Nasolabial Folds
Condition: Nasolabial Folds
Study type: Interventional

Summary: 
      Safety & tolerability study that compares Restylane to Restylane with Lidocaine (Restylane-L)
      while correcting wrinkles in the area around your nose.
    

Detailed description: 
      A Randomized, Double-Blind Study Comparing Safety and Tolerability of Restylane® With and
      Without Addition of 0.3% Lidocaine HCL During Correction of Nasolabial Folds
    

Intervention name(s): Restylane and Restylane-L
Intervention type(s): Device
Intervention description(s): This is a split face design and each subject received both Restylane and Restylane-L. Treatments were double blind, randomized, and successive.
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Correction of Nasolabial Folds
Follow-up Efficacy and Safety of Alitretinoin in Severe Chronic Hand Dermatitis
Condition: Hand Dermatoses
MeSH terms: Dermatitis; Skin Diseases; Hand Dermatoses
Study type: Interventional
Phase: Phase 3

Summary: 
      Patients who have been treated in study protocol BAP089 may have responded to treatment, and
      subsequently relapsed to >75% of the baseline disease severity, will be investigated for
      response to further treatment with alitretinoin. Also, patients who have responded with mild
      or moderate disease will be investigated for additional treatment effect after prolongated
      treatment.
    


Intervention name(s): alitretinoin
Intervention type(s): Drug
Intervention MeSH terms: Alitretinoin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Other
Keywords: Patients who have been enrolled in study protocol BAP089, and whose severe chronic hand dermatitis responded with mild or moderate disease, or who relapsed