bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Tea Consumption on Steroid Profile in Healthy Volunteers
Condition: Healthy Volunteers; Doping in Sports
Study type: Interventional
Phase: Phase 1

Summary: 
      Open label phase I clinical trial in healthy volunteers designed to assess changes on steroid
      profile after green tea consumption.
    

Detailed description: 
      Anabolic androgenic steroids are included in the list of banned substances in sports by the
      World Anti-Doping Agency (WADA) because of its ability to improve the performance of
      athletes.

      Testosterone glucuronization by UGT2B17 isoenzyme (Uridine Diphosphate Glucuronyltransferase
      2B17) is inhibited in vitro by green tea flavonols like epicatechin, epigallocatechin gallate
      (EGCG) and catechin gallate.

      Therefore a diet rich in green tea could interfere in androgens' glucuronization and cause a
      change on the steroid profile of the athletes that could be considered a false positive.

      A clinical trial designed to assess changes on steroid profile in healthy volunteers after
      green tea consumption will be conducted. Subjects with different UGT2B17 genotype will be
      recruited (10 of each type: ins/ins, ins/del, del/del) to study if the genotype can modulate
      the results obtained.

      Urine samples obtained before and during 7 days of green tea consumption will be used to
      compare steroid profile. Blood samples will be also collected to assess EGCG
      pharmacokinetics.
    

Intervention name(s): Green tea
Intervention type(s): Dietary Supplement
Intervention description(s): Lipton pure green tea, 5 teas on the first 6 days, and 9 teas on the day 7. Teas will be ingested at 08:00 am, 10:30 am, 13:00 pm, 15:30 pm, 18:00 pm days 1-6, and 08:00 am (*), 10:30 am, 13:00 pm (*), 15:30 pm, 18:00 pm (*), 20:30 pm on day 7.
One bag of tea will be used to prepare the beverages with exception of some beverages on day 7 that will be prepared with two bags (*).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: green tea; steroid profile
Stem Cell Educator Therapy in Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Type 2 diabetes is the most common form of diabetes. The prevalence of diabetes has been
      markedly increased in recent years. More and more children and young adults develop this
      devastating disease. Despite of multiple factors (e.g., food, environmental, and genetic
      factors) contributing to the developing of diabetes, increasing evidence demonstrated that
      chronic inflammation and/or atuoimmunity are common issues and play key roles in the
      pathogenesis of type 2 diabetes, leading to the insulin resistance and the shortage of
      insulin-producing islet beta cells. Thus, anti-inflammation is becoming a novel approach for
      the treatment of type 2 diabetes. Evidence that multipotent stem cells derived from human
      cord blood (CB-SCs) can control inflammation and autoimmune responses by altering regulatory
      T cells (Tregs) and human islet beta cell-specific T cell clone in type 1 diabetes offers
      promise for a new approach to treat type 2 diabetes. Here, the investigators develop a novel
      Stem Cell Educator therapy by using CB-SC and explore the therapeutic effectiveness of Stem
      Cell Educator therapy in T2D patients.
    


Intervention name(s): Stem Cell Educator
Intervention type(s): Device
Intervention description(s): For the treatment, commonly the left (or right) median cubital vein, a patient's blood is passed through a Blood Cell Separator that isolates the lymphocytes from the blood according to the recommended protocol by manufacture; consequently, the collected lymphocytes were transferred into the Stem Cell Educator and treated by CB-SC; after that, the educated cells return the blood back to the patient via a dorsal vein of hand. During the MCS+ collection, the whole blood flow rate was maintained at 35 mL/min. The whole procedure was scheduled for 6 ~ 7 hrs.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cord blood stem cells; inflammation; type 2 diabetes; stem cell educator; autoimmunity; immune modulation
Mandibular Ridge Splitting Versus Khoury Shell Technique
Condition: Horizontal Augmentation of Atrophic Posterior Mandible
MeSH terms: Atrophy
Study type: Interventional

Summary: 
      Mandibular ridge splitting with complete separation of the buccal cortical plate versus
      Khoury shell technique for horizontal augmentation of atrophic posterior mandible
    


Intervention name(s): ridge splitting in group and khoury shell technique in the other group
Intervention type(s): Procedure
Intervention description(s): Mandibular ridge splitting with complete separation of the buccal cortical plate for horizontal augmentation of atrophic posterior mandible in one group and the other group will receive khoury shell technique by taking bone block from the ramus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Study in Patients With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine which dose of the investigational drug is the most
      safe and effective in the treatment of asthma compared to the control drug.
    


Intervention name(s): Formoterol Fumarate
Intervention type(s): Drug
Intervention MeSH terms: Formoterol Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Asthma; Formoterol; Fumarate
A Feasibility Study Looking at the Use of Glibenclamide and metfoRmin Versus stAndard Care in gEstational diabeteS
Condition: Pregnancy; Gestational Diabetes
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this open label feasibility study is to determine recruitment rates to a
      randomised trial of glibenclamide compared with insulin (both in addition to maximum
      tolerated metformin) for the treatment of Gestational Diabetes Mellitus (GDM). This
      feasibility trial will inform the design of a future substantive multicentre trial to test
      the hypothesis that combination therapy with glibenclamide and metformin could reduce the
      number of pregnant women with GDM who require insulin and would be superior to metformin and
      insulin in terms of acceptability and cost effectiveness.

      Women with GDM who have "failed" monotherapy with metformin will be recruited and randomised
      to either receive glibenclamide (test arm) or standard care with insulin, both in addition to
      their maximum tolerated dose of metformin. Patients will be recruited from three of the
      antenatal clinics.

      This is a feasibility study in preparation for a large multicentre randomised trial to test
      the hypothesis that the addition of glibenclamide to metformin (combination therapy) could
      reduce the number of pregnant women with gestational diabetes mellitus requiring insulin,
      without compromising glycaemic control or other clinical outcomes. The investigators
      hypothesise that combination therapy with metformin and glibenclamide is likely to be
      preferable to metformin and insulin in terms of acceptability and cost.
    


Intervention name(s): Glibenclamide; Insulin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Glyburide
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pregnancy; Gestational diabetes; Glycaemic control; Metformin
Correlates of GERD Symptom Severity
Condition: GERD
MeSH terms: Gastroesophageal Reflux
Study type: Observational

Summary: 
      This is a pilot study measuring physiologic and behavioral correlates of symptom severity in
      adult patients with gastroesophageal reflux disease (GERD).
    

Detailed description: 
      Subjects will complete questionnaires regarding their GERD-related symptoms and have a visit
      with a study clinician regarding their symptoms. We will measure heart rate variability and
      galvanic skin response in patients during the visits and video record the visits. Subjects
      will complete a daily GERD symptom diary for 2 weeks and then return to the study center to
      complete additional questionnaires and an exit interview.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adults with active GERD-related symptoms.
      
Keywords: GERD; Galvanic Skin Response; Heart Rate Variability
Magnetic Resonance Imaging Screening in Li Fraumeni Syndrome
Condition: Li-Fraumeni Syndrome
MeSH terms: Li-Fraumeni Syndrome; Syndrome
Study type: Observational

Summary: 
      This study is aimed at exploring the use of whole body MRI for early cancer detection in TP53
      mutation carriers and population controls, with the hypothesis that more cancers will be
      detected in the TP53 mutation carrier group. A secondary end-point will be the number of
      incidental findings detected and subsequent investigations required. A series of
      questionnaires will be used to assess the psychological impact of screening on both the study
      and control group.
    


Intervention name(s): Whole body MRI; Psychological questionnaires
Intervention type(s): Other; Other
Intervention description(s): Individuals will undergo whole body and brain MRI; All recruits will complete questionnaires at 6 time points to assess psychological impact
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The TP53 mutation carriers will be recruited from genetics clinics and through advertising.

        The population controls will be recruited through advertising
      
Keywords: Li-Fraumeni Syndrome; Whole Body Magnetic Resonance Imaging; TP53; Psychological Impact
Topiramate Versus Placebo as add-on Treatment in Patients With Bipolar Disorder in the Outpatient Setting
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the efficacy and safety of adding topiramate as
      compared to placebo to the medications a patient with bipolar disorder is already taking
      (lithium or valproate) to see if adding topiramate will better control the patient's manic
      symptoms.
    

Detailed description: 
      Many patients with bipolar disorder (manic-depressive illness) require more than one
      medication to control their symptoms. This is a 12-week, multicenter, randomized,
      double-blind, placebo-controlled, parallel-groupd study to evalute the efficacy and safety of
      topiramate versus placebo as add-on therapy to lithium or valproate for the treatment of
      bipolar 1 disorder as an outpatient setting. These patients must already be taking either
      lithium or valproate for at least 6 weeks before the first visit and have been on the same
      dose of the mood stabilizer for at least 2 weeks before the first visit. Paitents will be
      randomized to receive either placebo or topiramate, an anti-seizure medication not approved
      for the treatment of bipolar disorder, in addition to their lithium or valporate. The study
      consists of 56-day titration (topiramate will be titrated up to 400mg per day or the maximum
      tolerated dose), 28-day continuation period, and 7 days of follow-up to taper off the
      medication. The study hypothesis is that topiramate will be more effective than placebo in
      the treatment of mania in type 1 bipolar disorder patients as measured by the Young Mania
      Rating Scale (YMRS) and will be well tolerated. YMRS is a questionnaire consisting of 11
      items designed to assess severity of mania symptoms.

      Patients will start taking topiramate 25 mg per day or placebo by mouth. Over the next 8
      weeks, doses will be increased to up to 400 mg per day or to the maximum tolerated dose,
      whichever is lower. After the first 8 weeks, patients will stay at the established dose for
      the next 4 weeks.
    

Intervention name(s): topiramate
Intervention type(s): Drug
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Manic depression; Mania; Depression; Bipolar disorder; Psychosis
Drug-Drug Interaction Study to Estimate the Effect of PF-07321332/Ritonavir and Ritonavir on Midazolam in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to estimate the effect PF-07321332/Ritonavir and Ritonavir on
      Midazolam (a cytochrome P450 [CYP]3A4 substrate) in Healthy Adult Participants.
    


Intervention name(s): Midazolam; PF-07321332/ritonavir + Midazolam; Ritonavir + Midazolam
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Midazolam administered as a single dose on Day 1; PF-07321332/ritonavir:
Administered orally every 12 hours for a total of 9 doses on Days 1-5
Midazolam:
Administered orally as a single dose on Day 5; Ritonavir:
Administered orally every 12 hours for a total of 9 doses on Day1-5.
Midazolam:
Administered orally as a single dose on Day 5
Intervention MeSH terms: Ritonavir; Nirmatrelvir; Midazolam
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a Phase I, crossover, 3-treatment, 6-sequence study to evaluate the effect of PF-07321332/ritonavir and ritonavir on the PK of midazolam in healthy participants. Midazolam is a substrate for CYP3A4. A total of approximately 12 healthy male and/or female participants will be enrolled into the study.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Drug-drug interaction; Midazolam; COVID-19 (Coronavirus disease 2019); SARS-CoV (severe acute respiratory syndrome coronavirus)
Triceps Surae Trigger Point Size and Muscle Extensibility
Condition: Limited Dorsiflexion; Limited Ankle Range of Motion
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effectiveness of dry needling in improving
      ankle range of motion and functional outcomes. There have been an increasing number of
      studies on dry needling as an intervention for pain but none thus far that have studied
      functional outcome measures of the ankle. The study will include healthy male subjects
      between the ages of 18-30 years old randomized in to 3 intervention groups of: dry needling
      of the triceps surae, triceps surae stretching only, dry needling and stretching. The
      subjects who receive dry needling as an intervention will have the trigger point identified
      and dry needling performed while under musculoskeletal ultrasound visualization. The subjects
      will undergo pre and post intervention testing including Lower Quarter Y-Balance test,
      passive ankle dorsiflexion, closed chain half kneeling dorsiflexion, standing dorsiflexion,
      deep squat, multisegmental flexion as well as Marx Activity Level Scale. There will be 3 days
      between the initial testing/intervention and follow up. These outcomes will be the primary
      variables of interest. Ultrasound, Y balance testing, self stretching, and range of motion
      measurements are safe and pose no risk to the subject. Dry Needling has been found to be very
      safe and effective in the hands of physical therapists with a calculated risk of adverse
      events to be less than 0.04%.
    


Intervention name(s): Dry Needling; Stretching
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
The Role of Reactive Thrombocytosis in Children With Pneumococcal Infection
Condition: Thrombocytosis; S. Pneumoniae Infection
MeSH terms: Infections; Communicable Diseases; Pneumonia; Pneumococcal Infections; Thrombocytosis
Study type: Observational

Summary: 
      Thrombocytosis, mostly reactive in nature, is common in pediatric hospitalized patients with
      infections. Streptococcus pneumoniae (S. Pneumoniae) is the most common pathogen. In this
      study, the investigators investigated the associations of clinical profiles and
      thrombocytosis and evaluated platelet counts, leukocyte counts and CRP levels as predictors
      of hospitalization days in patients with S. pneumoniae infection.
    


Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric hospitalized patients less than 18 year-old.
      
Keywords: S. pneumoniae; thrombocytosis; pediatric patients; The study aimed to understand the diagnostic value of thrombocytosis in children with S. pneumoniae infection
Prospective Study of Comparison Between the Modified Atkins Diet and Classic Ketogenic Diet for Intractable Childhood Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Observational

Summary: 
      The Ketogenic diet is a now proven, evidence based treatment of refractory epilepsy. the
      classic ketogenic diet (KD) is based on a ratio of fat to carbohydrate and protein, usually
      3:1 or 4:1. Fat is proven long-chain triglycerides. The efficacy of the KD has been proven by
      many multicenter trials. But, side effects of ketogenic diet therapy is severe. The modified
      atkins diet (MAD) was designed and investigated at Johns Hopkins Hospital, which aimed to
      propose a less restrictive dietary treatment that would be more palatable to children and
      adolescents with less side effects. The MAD consist of a nearly balance diet (60% fat, 30%
      protein, and 10% carbohydrates by weight), without any restriction on the recommended daily
      calories. Some literature suggested that the MAD is an effective treatment for refractory
      epilepsy. But, no randomised controlled study has been tried. the investigators aimed in this
      prospective study to evaluate the efficacy, safety and tolerability of MAD comparing to KD.
      The patients were recruited between age 3 to 18 years old with intractable epilepsy. Enrolled
      patients were randomly assigned to either one of two groups; the KD group and MAD group. The
      patients were required to attend outpatient clinic after 1, 3month to record their seizure
      frequency and severity, while their dietary treatment.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        the patients were recriuted from the Pediatric Neurology Outpatient Clinic, Severance
        Children's Hospital. This study conducted on 104 (Ketogenic diet - 51, Atkin's diet - 53)
        patients diagnosed with intractable epilepsy which shows frequency with more than 1 per
        week, 4 per month even though at least more than 2 antiepileptic drug treatment.
      
Keywords: Seizure control through dietary therapy in pediatric intractable epilepsy patients.
Multicenter Study for Pediatric Subjects Evaluating Pharmacokinetics and Safety of EXPAREL
Condition: Postoperative Pain Management
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Objective: To evaluate the pharmacokinetics (PK) of EXPAREL in pediatric subjects
      aged 6 to less than 17 years undergoing various types of surgeries.

      Secondary Objective: To evaluate the safety of EXPAREL in pediatric subjects aged 6 to less
      than 17 years undergoing various types of surgeries.
    

Detailed description: 
      This is a Phase 3, two-part, multi-center, open-label study designed to evaluate the PK and
      safety profile of EXPAREL in pediatric subjects aged 6 to less than 17 years when
      administered intraoperatively at the end of surgery via local infiltration. 90 pediatric
      subjects undergoing spine and/or cardiac surgeries are planned for enrollment.

      Part 1 is a multicenter, randomized, open-label study in subjects aged 6 to less than 17
      years undergoing spine or cardiac surgeries. There will be 2 treatment groups: Group 1 will
      include subjects aged 12 to less than 17 years, while Group 2 will include subjects aged 6 to
      less than 12 years

      Part 2 is a multicenter, randomized, open-label, safety study in subjects aged 6 to less than
      17 years undergoing spine or cardiac surgeries. There will be 2 treatment groups: Group 1
      will include subjects aged 12 to less than 17 years, while Group 2 will include subjects aged
      6 to less than 12 years.

      Subjects will be screened within 30 days prior to study drug administration. During the
      screening visit, subjects will be assessed for past or present neurologic, cardiac, and
      general medical conditions that, in the opinion of the investigator, would preclude them from
      study participation.

      Subjects will undergo their pre-planned spinal or cardiac surgeries per the institution's
      standard of care. On Day 1, eligible subjects will receive the study drug intraoperatively at
      the end of surgery via local infiltration into the surgical site. Dosing of EXPAREL will be
      based on body weight, with a starting dose of 4 mg/kg (maximum 266 mg).

      There is no required length of stay in the hospital; subjects may be discharged based on the
      medical judgment of the treating physician.

      A follow-up phone call will be scheduled for all subjects on Day 7. A final follow-up visit
      will be made on Day 30 to all subjects who would have received the study drug.
    

Intervention name(s): Exparel; 0.5% Bupivacaine HCl
Intervention type(s): Drug; Drug
Intervention description(s): EXPAREL 4mg/kg (maximum 266 mg); Bupivacaine HCl 2mg/kg
Other intervention name(s): Liposomal bupivacaine; Bupivacaine
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatric