bioihbjkbjnl/mcl2 huggingface dataset:
Threonine Requirement in IBD Adults and Healthy Adult Controls
Condition: Ulcerative Colitis; Crohn's Disease; Healthy
MeSH terms: Crohn Disease; Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional

Summary: 
      The daily requirement of threonine, an essential amino acid, will be evaluated in healthy
      adult males and in adult males with Crohn's Disease or ulcerative colitis using the indicator
      amino acid oxidation (IAAO) method. Participants will consume specially formulated diets with
      varying levels of threonine.
    

Detailed description: 
      Threonine is an essential amino acid which must be obtained from the diet. It is a component
      of mucin. Mucin, in turn, is a key protein in the mucous membrane that protects the lining of
      the intestine.

      Inflammatory bowel disease (IBD) is a group of inflammatory conditions that affect the colon
      and small intestine. IBD primarily includes ulcerative colitis (UC) and Crohn's disease (CD).
      In UC, the inflammation is usually in the colon whereas in CD inflammation may occur anywhere
      along the digestive tract. Studies in animals have shown that more threonine is used when
      there is inflammation in the intestine.

      The threonine requirement in healthy participants and in IBD patients will be determined
      using the indicator amino acid oxidation method. The requirement derived in healthy
      participants will be compared to that derived in patients with IBD.

      Each participant will take part in two x 3 day study periods. The first two days are called
      adaptation days where the subjects will consume a liquid diet specially designed for him. The
      diet will be consumed at home. It contains all vitamins, minerals, protein and all other
      nutrients required. On the third day, the participant will come to the Hospital for Sick
      Children in Toronto. Subjects will consume hourly meals for a total of 8 meals and a stable
      isotope 13C-phenylalanine. Breath and urine samples will be collected to measure the
      oxidation of phenylalanine from which the threonine requirement will be determined.
    

Intervention name(s): Threonine
Intervention type(s): Other
Intervention description(s): Threonine will be fed at various intake levels ranging from high to low in order to determine its requirement in healthy males and in patients with Crohn's disease and Ulcerative colitis.
Other intervention name(s): amino acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Ulcerative Colitis; Healthy Controls; Crohn's Disease
A Study of the Safety, Tolerability, and Pharmacokinetics of AGG-523 in Healthy Japanese Males
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the safety and tolerability of ascending, multiple oral doses of AGG-523 in healthy
      Japanese subjects.
    


Intervention name(s): AGG-523
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
A Study of Infliximab in the Treatment of Chinese Children With Crohn's Disease
Condition: Crohn Disease
MeSH terms: Crohn Disease
Study type: Observational

Summary: 
      The main purpose of this study is to record the use of Infliximab (IFX) in the treatment of
      Chinese children with Crohn's disease (CD) in routine clinical practice and to summarize the
      clinical efficacy and safety of IFX in the treatment of pediatric CD.
    


Intervention name(s): Infliximab
Intervention type(s): Drug
Intervention description(s): Participants will be observed who were treated with Infliximab.
Intervention MeSH terms: Infliximab
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants observed in this study will be pediatric participants with Crohn's disease who
        have signed the ICF and are treated with infliximab.
Electrophysiological Effects of Irbesartan in Patients With Paroxysmal Atrial Fibrillation (AF)
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 3

Summary: 
      The main purpose of the study is to compare the mean AERP between treatment groups based on
      the hypothesis that in subjects with paroxysmal AF, Irbesartan prevents electrophysiological
      remodeling resulting in a prolonged atrial effective refractory period relative (AERP) to
      placebo.
    


Intervention name(s): Irbesartan; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablets, Oral, 300 mg, once daily, 30 days.; Tablets, Oral, 0 mg, once daily, 30 days.
Other intervention name(s): Avapro
Intervention MeSH terms: Irbesartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Patients with Paroxysmal Atrial Fibrillation (PAF)
The Safety and Efficacy of Intralymphatic Immunotherapy in Pollen Allergic Adolescents and Young Adults With Asthma
Condition: Rhinitis; Asthma; Allergy
MeSH terms: Rhinitis; Asthma
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The study evaluates the safety and efficacy of intralymphatic allergen-specific immunotherapy
      given to adolescents and young adults who are allergic to grass or birch pollen and have mild
      or moderate asthma. Patients will be treated with three intralymphatic injections; 1000 SQ-U
      x3 with 4-5 weeks interval, or placebo with 4-5 weeks interval. The patients receiving
      treatment will be given a fourth injection one year after the initial injections. The study
      is conducted in collaboration between Professor Lars Olof Cardell (ENT), prof Gunilla Hedlin
      (Pediatrics) and prof Marianne van Hage (Immunology)".
    

Detailed description: 
      30 patients with seasonal allergic rhinitis due to birch or grass pollen are included. Study
      subjects are randomized to intralymphatic injections with placebo or ALK Alutard 5-grasses /
      birch or placebo. The patients receiving treatment will be given a fourth injection one year
      after the initial injections.
    

Intervention name(s): ALK Alutard birch or 5-grasses; ALK diluent 0,3% human albumin
Intervention type(s): Drug; Drug
Intervention description(s): Intralymphatic injection with 1000 units. 3 injections with 4-5 weeks interval (0,1 ml) and one additional booster injection with 1000 units before the second pollen season.; Intralymphatic injection with 0.1 ml. 3 injections with 4-5 weeks interval
Other intervention name(s): ALK Alutard birch pollen or ALK Alutard grass pollen; Human albumin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effect of Repetitive Transcranial Direct Current Stimulation (tDCS) on Chronic Pelvic Pain
Condition: Chronic Pelvic Pain; Interstitial Cystitis; Post Traumatic Stress Disorder; Fibromyalgia; Irritable Bowel Syndrome
MeSH terms: Fibromyalgia; Irritable Bowel Syndrome; Cystitis; Cystitis, Interstitial; Syndrome; Pelvic Pain; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      We will rigorously test whether modulation of the motor cortex by transcranial direct current
      stimulation (tDCS) is an effective treatment for patients with chronic pelvic pain through
      the following specific aims:

      A) The primary aim of this study is to determine whether transcranial direct current
      stimulation applied to the motor cortex in patients with chronic pelvic pain induces a
      significant decrease in the pain or symptoms as compared with sham tDCS. We will also measure
      changes in the clinical symptom scores of multiple pelvic organs, drug intake (narcotic),
      anxiety, depression, traumatic stress, as well as overall improvement in the quality of life
      to assess the effects of this treatment.

      B) Determine the duration of the clinical effects of tDCS. We will therefore compare the
      amelioration of pain and related symptoms between active and sham tDCS for one year following
      treatment.

      C) Determine whether tDCS changes the threshold for pain detection as compared with sham
      tDCS. Patients with chronic pelvic pain have a lower threshold for pain as compared to
      healthy subjects and we hypothesized that this threshold will increase after stimulation with
      tDCS.

      D) Finally, we will examine whether 5 days of tDCS treatment is safe for use in chronic
      pelvic pain patients. Safety will be assessed through neuropsychological tests and adverse
      event reporting.
    


Intervention name(s): tDCS; tDCS
Intervention type(s): Procedure; Procedure
Intervention description(s): During each session, the anode electrode will be placed on the motor cortex (contralateral to the most [or predominant] painful side [or the side where the symptoms begin or the left as a default]) and the cathode will be placed over the contralateral supraorbital area. In active tDCS subjects, 1 mA of transcranial direct current stimulation will be applied for 30 minutes.; For sham-controlled tDCS subjects, the same montage will be used; however current will be applied only for 30 seconds.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: vulvodynia; painful bladder syndrome; myofascial pain syndrome; pelvic floor tension myalgia
Clinical Evaluation of Total-Etch and Self-Etch Dental Adhesives - 6 Year Recall
Condition: Dental Bonding
Study type: Observational

Summary: 
      Purpose: To evaluate the performance of several dental adhesives used for bonding
      tooth-colored fillings to teeth 6 years after the fillings have been placed.

      Participants: Subjects which had participated in the study entitled "Clinical Evaluation of
      New Total-Etch and Self-Etch Dental Adhesives" (IRB Study #07-0673).

      Procedures (methods): Fillings that had been placed 6 years ago will be evaluated by a
      direct, visual examination. Close-up intra-oral clinical photographs of each filling will be
      made. An impression of the filling may be obtained.

      The specific study aim of this 6-year recall of the patients treated in IRB Study #07-0673 is
      to evaluate the fillings placed according to the following characteristics: Retention; Color
      match; Cavosurface margin discoloration; Secondary caries; Anatomic form; Marginal adaptation
      and/or integrity; Post-operative sensitivity.
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects who participated in a 2007 study entitled "Clinical Evaluation of New Total-Etch
        and Self-Etch Dental Adhesives" (UNC IRB Study #07-0673).
      
Keywords: dental bonding
A Study of LY3493269 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the safety and tolerability of LY3493269 in
      healthy participants. The blood tests will be performed to check how much LY3493269 gets into
      the bloodstream, how long the body takes to eliminate it and how body handles LY3493269. The
      study will last up to approximately 71 days for each participant, including screening
    


Intervention name(s): LY3493269; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally.; Administered orally.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Standardized Lycium Chinense Fruit Extract Enhances Attention and Cognitive Function in Healthy Young People
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      Lycium chinense fruit (LCF) is widely distributed in East Asia that has been used
      traditionally for anti-aging purposes. This study was performed to examine the effects of LCF
      on attention and cognitive function in healthy young people. An 11-week, double-blind,
      randomized, placebo-controlled, crossover trial was conducted.
    

Detailed description: 
      The Computerized Neurocognitive function Test (CNT), the Korean version of the
      Attention-deficit/hyperactivity disorder (ADHD) Rating Scale-IV (K-ADHD-RS-IV), the Clinical
      Global Impression (CGI) rating scale, the Frankfurt Attention Inventory (FAIR), and
      resting-state electroencephalogram (EEG) were conducted before and after the experiment.
    

Intervention name(s): Standardized Lycium chinense Fruit Extract (LCF) capsules
Intervention type(s): Dietary Supplement
Intervention description(s): All dried water extracts and capsules of the Standardized Lycium chinense Fruit Extract (LCF) and Standardized Lycium chinense Fruit Extract (LCF)-matched placebo capsules used in the present study were manufactured and provided by the BIOMIX Company (Ilsan City, Korea).
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants receive one of two (or more) alternative interventions during the initial phase of the study and receive the other intervention during the second phase of the study
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Lycium chinense fruit
Mitral Valve Management During Septal Myectomy
Condition: Hypertrophic Cardiomyopathy
MeSH terms: Cardiomyopathies; Cardiomyopathy, Hypertrophic; Hypertrophy
Study type: Interventional

Summary: 
      Objective of the study: to evaluate whether alfieri technique improves clinical and
      hemodynamic results compared to transaortic mitral valve secondary cord cutting in patients
      scheduled to septal myectomy for severely symptomatic hypertrophic obstructive
      cardiomyopathy.
    

Detailed description: 
      There is pilot prospective randomised study comparing immediate and early results of
      additional subvalvular mitral apparatus intervention versus additional alfieri stich in
      patients scheduled to septal myectomy for symptomatic obstructive cardiomyopathy.

      Patients with proven hypertrophic cardiomyopathy and resting left ventricle outflow tract
      obstruction underwent septal myectomy. If patients were suitable for both surgical
      techniques, they were randomized to alfieri stich or secondary cord cutting. All surgeons
      were experienced at least 50 related procedures.
    

Intervention name(s): Septal myectomy; alfieri stich; Subvalvular intervention
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Transaortic septal myectomy; Transaortic Mitral valve repair using alfieri technique; Transaortic Mitral valve subvalvular intervention including anterior mitral leaflet secondary cord cutting, papillary muscle release
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: septal myectomy; hypertrophic cardiomyopathy
Glizigen-Viudid-External Anogenital Warts in Children and Adolescents
Condition: External Anogenital Warts
MeSH terms: Warts; Condylomata Acuminata
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to assess the efficacy of Glizigen and Viusid administration in
      the treatment of external anogenital warts in children and adolescents. The duration of this
      double-blind placebo controlled phase 3 clinical trial will be 12 weeks. The estimated number
      of persons to be recruited and randomized for the study is 76. Variables to be assessed will
      be: time to disappearance of lesions, reduction of the number of lesions and change in the
      aspect of lesions.
    


Intervention name(s): Glizigen + Viusid; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Glizigen (spray, 60 mL bottle with applicator): Dosage commensurate with surface (up to a maximum of 10 cm2) to be treated. From 3 to 5 ambulatory applications (One nebulization corresponds to 2 short pulses).
1 to 3.9 cm2 ______________3 daily applications
4 to 6.9 cm2 ______________4 daily applications
7 to 10 cm2 ______________5 daily applications Treatment will last from 5 days to 8 weeks according to clinical improvement.
Viusid (Syrop, 500 mL flask): 12.5 ml every 8 hours for 12 weeks. Viusid syrop should be dissolved in water, fruit juice or milk before ingestion.; Placebo Glizipen (spray, 60 mL bottle with applicator): Dosage commensurate with surface (up to a maximum of 10 cm2) to be treated. From 3 to 5 ambulatory applications (One nebulization corresponds to 2 short pulses).
1 to 3.9 cm2 ______________3 daily applications
4 to 6.9 cm2 ______________4 daily applications
7 to 10 cm2 ______________5 daily applications Treatment will last from 5 days to 8 weeks according to clinical improvement.
Placebo Viusid (Syrop, 500 mL flask): 12.5 ml every 8 hours for 12 weeks. Viusid syrop should be dissolved in water, fruit juice or milk before ingestion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dietary supplement; Anogenital warts; Viusid; Glizigen
Induced ACL Healing With the Ligamys Technique: a Prospective, Multicenter Observational Case Series
Condition: Anterior Cruciate Ligament Rupture
MeSH terms: Rupture
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of the Ligamys
      technique for the treatment of acute ruptures of the anterior cruciate ligament in a
      multicenter routine clinical setting. To conduct a long-term follow-up of the case series as
      a post-market product surveillance endeavor.
    

Detailed description: 
      The Ligamys method was successfully applied in an animal study including eleven white alpine
      sheep. Healing of the torn ACL and a stable joint without signs of intra-articular damages or
      osteoarthritis three months postoperative were observed (Kohl KSSTA 2013). In a first
      clinical study with ten patients, the Ligamys surgical technique resulted in stable clinical
      and radiological healing of the torn ACL in nine patients with one re-rupture after four
      months. Nine patients obtained normal knee scores, reported excellent patient satisfaction,
      and could return to their previous levels of sporting activity (Kohl Swiss Med Wkly 2011).

      The purpose of this study is to evaluate the safety and effectiveness of the Ligamys
      technique for the treatment of acute ruptures of the anterior cruciate ligament in a
      multicenter routine clinical setting. To conduct a long-term follow-up of the case series as
      a post-market product surveillance endeavor.
    

Intervention name(s): Ligamys
Intervention type(s): Device
Intervention description(s): All patients are treated with Ligamys within 21 days after injury. The Ligamys implant has to be used in accordance with the instructions for use.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with an acute rupture of the anterior cruciate ligament
      
Keywords: Ligamys; ACL; healing
Young Men and Media Study
Condition: Sexual Behavior
Study type: Interventional

Summary: 
      Adolescent sexual minority males (ASMM) continue to account for a disproportionate number of
      HIV infections in the United States. Racial and ethnic minority populations are particularly
      affected. Increased HIV rates reflect sexual risk behaviors during early sexual experiences.
      Research suggests that initial sexual risk-taking occurs during adolescence among sexual
      minority males. Therefore, it is important for HIV prevention interventions to target
      adolescent sexual minority males. Targeting sexual minority males during adolescence will
      help them learn and establish healthy sexual behaviors early in their psychosexual
      development, which will have both immediate and long-term health benefits.To promote
      adolescent sexual minority males' critical examination of online media and decrease their
      sexual risk-taking, this study proposes an exploratory clinical trial to pilot test an online
      sexual health media literacy intervention that was developed during formative research for
      feasibility and acceptability. Overall, the proposed research has the potential to reach a
      wide audience of sexual minority males early in their sexual development, ultimately
      decreasing their sexual risk-taking and reducing the number of new HIV infections in this
      population.
    


Intervention name(s): Young Men & Media Program; Available websites on safe sex and preventing STIs
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The online sexual health media literacy website includes content about (1) male anatomy; (2) HIV/STI prevention; (3) overall sexual health; and (4) sexually explicit online media (SEOM) literacy.; Available websites (such as by the CDC) that provide information about sexual health and preventing sexually transmitted infections (STIs) including HIV.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Adolescent sexual minority males (ASMM); gay, bisexual, and other men who have sex with me (GBMSM); Online sexual health media literacy intervention; HIV prevention; Healthy sexual behaviors
Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted globally (the United States of America excepted). This trial is
      designed to show the effect of treatment with liraglutide when added to existing glimepiride
      therapy and to compare this to both glimepiride monotherapy and to rosiglitazone as add-on
      therapy to glimepiride.
    


Intervention name(s): liraglutide; rosiglitazone; glimepiride
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Liraglutide; Glimepiride; Rosiglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment