bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Efficacy Trial of Mexiletine for Myotonic Dystrophy Type 1
Condition: Myotonic Dystrophy
MeSH terms: Myotonic Dystrophy
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the effects of mexiletine treatment for 6 months
      on ambulation, myotonia, muscle function and strength, pain, gastrointestinal functioning,
      cardiac conduction, and quality of life in myotonic dystrophy type 1 (DM1).
    

Detailed description: 
      This study will provide data on the long term (6 months) safety and efficacy of mexiletine
      in:

        -  improving the distance participants are able to walk in six minutes;

        -  reducing myotonia;

        -  improving muscle strength;

        -  increasing lean muscle mass;

        -  decreasing musculoskeletal pain;

        -  improving gastrointestinal function and swallowing);

        -  improving functional abilities;

        -  decreasing cardiac arrhythmias; and

        -  improving disease-specific health related quality-of-life.
    

Intervention name(s): Mexiletine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 150 mg/kg Mexiletine capsules taken by mouth, three times daily for 6 months; 150 mg/kg placebo capsules taken by mouth, three times daily for 6 months
Other intervention name(s): Generic name: mexiletine hydrochloride
Intervention MeSH terms: Mexiletine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Myotonic Dystrophy; Myotonic Dystrophy Type 1 (DM1); Muscular Dystrophy; Mexiletine
Bioequivalence Study of Vonoprazan From Topoprazan 20 mg Tablets (Hikma Pharma, Egypt) Versus Takecab 20 mg Tablets (Takeda Pharmaceutical Co. Ltd., Japan)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      An open label randomized, single dose, two-way crossover bioequivalence study to determine
      the bioequivalence of Vonoprazan From Topoprazan 20 mg Tablets (Hikma Pharma, Egypt) Versus
      Takecab 20 mg Tablets (Takeda Pharmaceutical Co. Ltd., Japan)
    

Detailed description: 
      Healthy volunteers, 18-55 years of age, selected from the Egyptian population fulfilling the
      selection criteria. All dosed subject samples will be analyzed and their data will be
      included in the final study report.

      Primary Pharmacokinetic Parameters: Cmax, AUC0→t and AUC0→∞ Secondary Pharmacokinetic
      Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for transformed (with the
      90% confidence intervals) and untransformed data of Cmax, AUC0→t and AUC0→∞ and for
      untransformed data of Ke, tmax and t1/2e.

      The confidence intervals of logarithmically transformed Test/Reference ratios for Cmax,
      AUC0→t and AUC0→∞ to be within 80.00-125.00%.

      A comprehensive final report will be issued upon the completion of the study.
    

Intervention name(s): Topoprazan; Takecab
Intervention type(s): Drug; Drug
Intervention description(s): 1 tablet contains 20 mg vonoprazan; 1 tablet contains 20 mg vonoprazan
Other intervention name(s): Takecab
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Acute Whey Protein And Casein Supplementation: Effect On Protein Metabolism After Resistance Exercise
Condition: Sports Nutrition; Protein Supplementation
Study type: Interventional

Summary: 
      The proteins of human breast milk are the most important endocrine signaling system that
      promotes neonatal growth by increasing the release of insulin, insulin-like growth factor-1
      (IGF-1), and the leucine-mediated mammalian target of rapamycin complex 1- (mTORC1) signaling
      of pancreatic β-cells. Remarkably, the branched-chain amino acids (BCAAs) leucine,
      isoleucine, and valine are involved in the growth-promoting effects of milk, protein
      biosynthesis, and metabolism because they physiologically stimulate insulin secretion The
      present study sought to investigate the effects of the combination of whey protein and casein
      in the ratio of 80:20 ("whey protein: casein" or "casein: whey protein") as breast milk
      proportion on the peak and the period of the permanence of branched-chain amino acids in the
      blood circulation, final metabolites of protein metabolism and delayed onset muscle soreness
      (DOMS) after a single bout of fasting or a resistance exercise session.
    

Detailed description: 
      The present study investigated the effects of the association of WP and casein in the ratio
      of 80:20, a similar ratio of human breast milk, on blood branched-chain amino acids (BCAAs)
      profile by HPLC technique, markers of protein metabolism (creatinine, urea, and urine
      nitrogen) and delayed onset muscle soreness (DOMS) after a single bout of resistance
      exercise. A double-blind, crossover and acute study was conducted with ten men (age 29 ± 8 y;
      BMI: 25.4 ± 2.9 Kg/m2; 77 ± 12 kg; 1.74 ± 0.09 m) that were randomly assigned to five
      supplementation treatments: WP - whey protein; CAS - casein; WP/CAS - 80% WP/20% CAS; CAS/WP
      - 80% CAS/ 20% WP; PLA - placebo. Participants were submitted to the following evaluations:
      performance sessions, blood collection for each session for the BCAAs profile determination,
      two food records, 3-days assessment of DOMS (24h, 48h, 72h) after each treatment.
    

Intervention name(s): Blend Protein Supplementation; Placebo Supplementation; Resistance Exercise
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): Protein supplementation using 20 grams of whey protein or casein mix. Acute Resistance training, 10 sets of 10 reps at 85% of 1Maximum repetition; Placebo supplementation using 20 grams of Maltodextrin. Acute Resistance training, 10 sets of 10 reps at 85% of 1Maximum repetition; 10 sets of 10 repetitions at 85% of 1 Maximum repetition in leg press exercise
Other intervention name(s): Resistance Training; Resistance Training
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBA-354 in Healthy Adult Subjects
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to evaluate the safety and tolerability of single oral doses
      of TBA-354 when administered to healthy adult subjects.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, single ascending dose study conducted
      at one study center in the United States. Six (6) cohorts of 8 subjects each (6 active and 2
      placebo), with one cohort crossing over to assess food effect, are planned for evaluation.
      Subjects will participate in only one cohort.

      Safety will be assessed throughout the study; serial ECGs and serial blood samples will be
      collected for the safety and PK assessment of TBA-354.

      Dose escalation to the next cohort (i.e., dose level) will not take place until the Sponsor,
      in conjunction with the Principal Investigator, has determined that adequate safety,
      tolerability and PK from the previous cohort has been demonstrated to permit proceeding to
      the next cohort. Upon review of cohort data, the Sponsor, in conjunction with the Principal
      Investigator, may decide to:

        1. Escalate dose as planned.

        2. Evaluate an intermediate dose level prior to proceeding to the next planned dose level
           if concerns arise from signs and symptoms that do not warrant ceasing escalation as
           described above.

        3. Repeat a given dose level in a new cohort of subjects.

        4. Halt the study.

      Blinded interim PK analyses will be performed for the dose escalation decisions, to select
      the intermediate dose for the food effect cohort, and to reconsider the sampling time points
      as the study progresses.

      Subjects will be housed in the Celerion clinic from at least 24 hours prior (from Day -2),
      until 48 hours after dosing. Subjects will return for subsequent follow up safety and PK
      assessments on Days 4 to 7 and will be contacted via a phone call for follow-up questioning
      about adverse events 7 days later (Study Day 14). One cohort will return after a washout of
      at least 14 days or five half-lives (whichever is longer) of their fasting dose to receive
      the same intermediate dose (TBD mg) under fed conditions.
    

Intervention name(s): TBA-354; Placebo
Intervention type(s): Drug; Other
Intervention description(s): TBA-354 supplied as a 20 mg /mL suspension and matching placebo suspension for oral administration.; Placebo Suspension
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Tuberculosis; TBA-354; Pulmonary Tuberculosis; TB
A Study to Evaluate Two Different Surgical Methods for Treatment for Abdominal Wall Diastasis
Condition: Abdominal Hernias and Other Abdominal Wall Conditions; Post-operative Pain; Recurrence
MeSH terms: Recurrence; Pain, Postoperative; Hernia, Abdominal; Internal Hernia
Study type: Interventional

Summary: 
      This is a three armed prospective randomized trial that will compare two different surgical
      techniques for reconstruction of the abdominal wall diastasis with a conservative treatment
      procedure.

      The study hypothesis:

      Which surgical approach provides the safest and best long term results for patients with
      abdominal wall diastasis either the insertion of net alternative with a double row suture or
      exercise alone?
    

Detailed description: 
      The conservative control group will receive a special training program for abdominal muscle
      training for 3 months,and all groups wearing girdle for 3 months.

      All patients examined with a CT scan before randomization and then a Biodex measurement of
      abdominal muscle strength.

      All patients must also complete the SF-36 (scientifically tested instruments to measure
      self-reported physical and mental health) and VHPQ (ventral hernia Pain Questionnaire).

      Two-thirds of patients receive surgery and followed up with a 3 month and 1-year control.At 1
      year of control, all go through a CT scan and a Biodex measurement of muscle strength.

      The control group followed up after one and half months and 3 months. In the surgery group,
      patients may not know what reconstruction they received before the final assessment after 1
      year.
    

Intervention name(s): Quill suture application for repair or polypropylene mesh
Intervention type(s): Procedure
Intervention description(s): The first arm may be insertion of the-mesh The second arm may double row- suture The third arm may be conservative -training
Other intervention name(s): Quill suture; And Soft mesh Polypropylene mesh
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Interpersonal Psychotherapy for Depressed Adolescents and Parents
Condition: Major Depression; Dysthymic Disorder; Adjustment Disorders; Depressive Disorder Not Otherwise Specified
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Adjustment Disorders; Dysthymic Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to examine the feasibility and acceptability of an adaptation of
      Interpersonal Psychotherapy for Depressed Adolescents (IPT-A) that includes greater and more
      structured involvement of the parents in the treatment.
    

Detailed description: 
      Adolescent depression is a significant public health problem, and it increases the risk of
      poor psychosocial outcomes in adolescence and adulthood. Interpersonal Psychotherapy for
      Depressed Adolescents (IPT-A) has been found to be an effective treatment for reducing
      adolescents' depressive symptoms and improving their global and social functioning. The
      purpose of the current study is to examine the feasibility and acceptability of IPT-A when it
      is delivered with greater and more structured involvement of the parents in the treatment.

      Participants will receive 15 weeks of Interpersonal Psychotherapy for Depressed Adolescents
      and Parents (IPT-AP). Eight the therapy sessions are conducted with the adolescent
      individually, two are with the parent(s) individually, and five are conducted with the
      adolescent and parent(s) together. At the end of the 15 weeks, participants who have
      demonstrated at least a 50% reduction in depressive symptoms will participate in three
      booster sessions delivered on a monthly basis. All participants will be assessed at baseline,
      week 5, week 10, week 15 (post-treatment), and 3 months post-treatment to measure depressive
      symptoms, global and social functioning, and attitudes toward treatment.
    

Intervention name(s): Interpersonal Therapy for Depressed Adolescents & Parents
Intervention type(s): Behavioral
Intervention description(s): 15 weekly psychotherapy sessions
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Major Depression; Dysthymic Disorder; Adjustment Disorder; With Depressed Mood; Depressive; Disorder Not; Otherwise; Specified; Adolescent; Psychotherapy
Synbiotic Treatment of Ulcerative Colitis Patients
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional

Summary: 
      Ulcerative colitis (UC) is one of the two main forms of inflammatory bowel disease. UC is
      associated with high morbidity and incurs significant social, commercial and NHS costs. For a
      variety of reasons, many patients are refractile to standard therapies, which often have
      undesirable side-effects. However, an inexpensive and non-toxic treatment based on the
      synbiotic concept may prove to be effective in these individuals. A synbiotic is a mixture of
      a probiotic (a live microorganism) and a prebiotic, which is a carbohydrate that serves as a
      food source for the probiotic, allowing it to grow better in the gut. The aim of this study
      is to determine whether a synbiotic comprised of fructooligosaccharides and inulin, together
      with a bifidobacterial probiotic (Bifidobacterium longum), that we have previously shown to
      reduce inflammatory processes in the gut wall (mucosa) in a short-term pilot trial, can
      colonise the bowel, reduce mucosal inflammation, and induce remission in UC patients with
      active disease. It is planned to establish a double-blinded, controlled, randomised
      investigation involving 46 patients for six months. If the results from our pilot study can
      be reproduced and maintained in a long-term investigation, the synbiotic could become
      available very quickly, and would provide an inexpensive and effective treatment for UC,
      making a significant contribution to relieving the clinical and financial burdens of this
      disease.
    


Intervention name(s): Synbiotic (Synergy1/B. longum)
Intervention type(s): Other
Intervention description(s): Probiotic Bifidobacterium longum Prebiotic Synergy 1
Other intervention name(s): prebiotic; probiotic
Intervention MeSH terms: Sulfalene
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Quantification of Balance in Acutely Concussed Athletes
Condition: mTBI; Concussion; Mild Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
Study type: Observational

Summary: 
      The purpose of this pilot project is to determine whether using inertial sensors placed on
      the waist during routine clinical balance testing (i.e. Balance Error Scoring System) (BESS),
      will be a more immediate, objective, reliable and sensitive way to measure and quantify
      balance deficits in individuals with mild Traumatic Brain Injury (mTBI). The investigators
      are also trying to observe if the sensors can be used to detect balance recovery after a
      mTBI.

      The investigators hypothesis is that collegiate atheltes with mTBI injury will have different
      recovery periods between their cognitive testing(IMPACT) and their balance measures.
    

Detailed description: 
      The purpose of this pilot project is to determine whether using inertial sensors (ipod like
      device) placed on the waist during routine clinical balance testing (i.e. Balance Error
      Scoring System (BESS), will be a more immediate, objective, reliable and sensitive way to
      measure and quantify balance deficits in individuals with mild Traumatic Brain Injury (mTBI).
      The investigators are also trying to observe if the sensors can be used to detect balance
      recovery after a mTBI.

      The participants will be recruited through the local university's athletic department.

      The participants will undergo balance tests from the BESS test while wearing a sensor around
      their waist.The BESS consists of different balance tests; such as balancing on one leg and
      tandem standing. The participants will also answer questionnaires about their daily lives and
      cognitive tests. If the participant has had a mTBI they will complete questionnaires about
      symptoms from their injury and may perform an additional IMPACT test which is a computerized
      cognitive tests used by coaches, athletic trainers and managing physicians.

      Along with the clinical balance tests and questionnaires, the project will use a small sensor
      placed on the waist to detect sway during quiet stance. An automatic analysis will occur
      which will provide us with immediate feedback on how stable the participant is during
      testing.
    

Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Collegiate atheltes
      
Keywords: mTBI; concussion; mild traumatic brain injury; athlete; college; football; soccer
Growth Hormone (GH) Deficiency & Insulin Like Growth Factor 1 (IGF-I)/ Insulin Like Growth Factor Binding Protein 3 (IGFBP-3) Ratio
Condition: Diagnosis of GHD With IGF-I/IGFBP-3 Ratio
MeSH terms: Disease
Study type: Observational

Summary: 
      A 35-month cross-sectional observational study was conducted at an outpatient university
      hospital in Amman, Jordan. We obtained a comprehensive medical and laboratory evaluation for
      134 short-statured children (64 boys and 70 girls, aged 4-16 years). Complete and partial
      growth hormone deficincy (GHD) were defined as peak forwth hormone (GH) response of 5 and 7
      ng/ml [IRMA/ DiaSorin®], respectively in both clonidine stimulation and insulin tolerance
      tests. Serum IGF-I, IGFBP-3 and IGF-I/IGFBP-3 ratio were determined for all participants.
    


Intervention name(s): IGF-1/IGFBP-3 ratio
Intervention type(s): Other
Intervention description(s): IGF-1/IGFBP-3 ratio for the diagnosis of GHD Vs. IGF-1, IGFBP-3 and IGF-1 & IGFBP-3 combination
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        192 children presented to JUH outpatient endocrinology clinic for the evaluation of short
        stature (SS). The target population of our study was male and female children, aged 4-16
        years, with short stature.
Severe Insulin Resistance in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance
Study type: Interventional

Summary: 
      The purpose of the study is to investigate some of the mechanisms behind severe insulin
      resistance and to determine the dose response to insulin in patients with type 2 diabetes
      mellitus.
    

Detailed description: 
      Overnutrition and obesity are pivotal to the metabolic syndrome and diabetes. The sedentary
      lifestyle and overly rich nutrition are predominant in Western societies and result in
      obesity, insulin resistance and type 2 diabetes mellitus. According to the WHO an escalating
      global epidemic of overweight and obesity is sweeping the globe and the prevalence of type 2
      diabetes mellitus rises in parallel at the same alarming rate. It is likely that inherited
      insulin resistance relates to subtle mutations in many metabolic genes. It is still unclear
      whether such abnormalities lead to different proteomic patterns in target tissues (muscle and
      fat) and how intracellular hormone signaling is affected. Some patients with type 2 diabetes
      mellitus have severe insulin resistance with insulin requirements of more than 100 units/day
      and are still not optimally controlled. Our aim of this study is to examine the mechanisms
      behind severe insulin resistance and to elucidate how intracellular hormone signaling is
      affected, especially in relation to proteomics. Moreover we wish to determine the dose
      response to insulin in patients with type 2 diabetes mellitus with severe insulin resistance
      in order to see if there is a measurable effect on blood glucose at high insulin doses.
    

Intervention name(s): Actrapid (human insulin)
Intervention type(s): Drug
Intervention description(s): On day one: 0,5 IU/kg/min for 3 hours, 1,5 IU/kg/min for 3 hours, on day two: 3,0 IU/kg/min for 3 hours, 5,0 IU/kg/min for 3 hours
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Type 2 diabetes; Severe insulin resistance
A Study of AK002 in Patients With Atopic Keratoconjunctivitis, Vernal Keratoconjunctivitis, and Perennial Allergic Conjunctivitis
Condition: Atopic Keratoconjunctivitis; Vernal Keratoconjunctivitis; Perennial Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic; Keratoconjunctivitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1b, open-label, study to assess the effects of AK002, given as monthly
      intravenous infusion for 6 doses at up to 3 mg/kg.
    


Intervention name(s): AK002
Intervention type(s): Drug
Intervention description(s): AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8, a member of the CD33-related family of sialic acid-binding, immunoglobulin-like lectins (Siglecs).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: AKC; PAC; VKC