bioihbjkbjnl/mcl2 huggingface dataset:
Assessment of Immune Activation and Tolerance in Celiac Disease During Gluten Challenge
Condition: Celiac Disease
MeSH terms: Celiac Disease
Study type: Interventional

Summary: 
      The primary purpose of this study is to characterize changes in gluten-specific T cells and
      pathology in the small intestine with specific focus on biomarkers likely to change with
      therapeutic celiac disease (CeD) treatment.
    

Detailed description: 
      Gluten challenge studies are used to test the effectiveness of therapies designed to prevent
      immune response to gluten in participants with CeD. The study will enroll approximately 20
      participants. Participants will be randomly assigned (by chance, like flipping a coin) in a
      1:1 ratio to one of the two treatment groups:

        -  Group A: Gluten 3 gm

        -  Group B: Gluten 10 gm

      All participants will be asked to take an oral dose of gluten at the same time on Days 1 to
      14 throughout the study. This multi-center trial will be conducted in the United States. The
      overall time to participate in this study is 10 weeks. Participants will visit to the clinic
      on Day -45 and will be contacted for follow-up assessment on Days 15 to 42.
    

Intervention name(s): Gluten
Intervention type(s): Dietary Supplement
Intervention description(s): Gluten powder.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Gluten Challenge
A Relative Bioavailability Study of Valacyclovir Hydrochloride Tablets 1gm Under Fed Condition
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      The study was conducted as an open-label, balanced, randomized, two-treatment, two-period,
      two-sequence, single-dose, crossover, bioequivalence study comparing Valacyclovir
      hydrochloride tablets 1 gram manufactured by OHM Laboratories Inc. NJ 08901 with VALTREX®
      caplets 1 gram manufactured by GlaxoSmithKline, Research Triangle Park, NC 27709 in healthy,
      adult, male, human subjects under fed condition.
    

Detailed description: 
      Following an overnight fast of at least 10 hour, a high-fat high-calorie breakfast was served
      to the study subjects. Thirty minutes after start of this breakfast, a single oral dose of
      Valacyclovir hydrochloride 1 gram of either test or reference investigational product was
      administered during each period of the study (on day 01 and 04), along with 240 mL of
      drinking water at ambient temperature under low light condition and under supervision of
      trained study personnel. Both test and reference products were administered to all the study
      subjects, one in each period (except subject number 14 who dropped out from the study and
      subject number 37 who was withdrawn from the study).

      During the course of the study, safety parameters assessed were vital signs, clinical
      examination, medical history and clinical laboratory safety tests (hematology, biochemical
      parameters, serology and urine analysis) at baseline. Adverse event monitoring was done
      throughout the study. Laboratory parameters of hematology and biochemistry (except blood
      glucose and cholesterol) were repeated at the end of the study.
    

Intervention name(s): Valacyclovir hydrochloride
Intervention type(s): Drug
Intervention MeSH terms: Valacyclovir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Valacyclovir hydrochloride fed study
Immunogenicity and Safety of a Purified Vero Rabies Vaccine
Condition: Rabies Virus
MeSH terms: Rabies
Study type: Interventional
Phase: Phase 2

Summary: 
      This multicenter, observer-blind, controlled, randomized, Phase II study was designed to
      evaluate different formulations of the Purified Vero Rabies Cell vaccine VRVg.
    

Detailed description: 
      This study assessed different formulations of the modified formulation of VRVg (VRVg 2-
      formulations 1 [low], 2 [medium] and 3 [high]) tested in parallel to the initial VRVg
      formulation (VRVg-1) and Imovax Rabies. Immune responses were assessed at Day 14, Day 28, Day
      42, and at Month 7. Safety events were also reported.
    

Intervention name(s): VRVg 2; VRVg 1; Imovax Rabies; VRVg 2; VRVg 2; Human Rabies Immunoglobulins (HRIG)
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Modified formulation 1 (Low) of Purified Vero Rabies Vaccine Serum Free; Initial formulation of Purified Vero Rabies Vaccine Serum Free; Purified inactivated rabies vaccine prepared on human diploid cell cultures; Modified formulation 2 (Medium) of Purified Vero Rabies Vaccine Serum Free; Modified formulation 3 (High) of Purified Vero Rabies Vaccine Serum Free; Commercialized formulation of HRIG
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; Antibodies
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rabies virus
A Clinical Study to Compare Two Revascularization Protocols to Treat Non-vital Teeth With Incomplete Root Formation
Condition: Dental Pulp Necrosis; Disorder of Tooth Development
MeSH terms: Dental Pulp Necrosis; Tooth Diseases; Necrosis
Study type: Interventional

Summary: 
      Both methods tested in this study disinfect the non-vital root canals and induce blood clot
      formation inside the root canal. One method places calcium hydroxide inside the root canal
      after disinfection and the blood clot is induced four weeks later.

      The other method performs disinfection and induction of blood clot in one appointment. The
      investigators hypothesize that both methods will obtain the same success rate in eliminating
      infection, increase in root length and canal walls thickness.
    

Detailed description: 
      Collagen is placed on top of the blood clot, followed by white MTA. Glass ionomer is used to
      seal the access to the canal, which will be replaced by a permanent restoration 3 months
      later.
    

Intervention name(s): Endodontic Regeneration
Intervention type(s): Procedure
Intervention description(s): Blood clot formation is induced in the root canal after disinfection. Collagen material is placed over the clot. The canal access is sealed with white MTA and glass ionomer restoration. Permanent restoration is placed 3 months later on top of the MTA.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Immature teeth; Calcium Hydroxide; Blood clot; Revascularization; Revitalization
Radial Artery Dilation Study: The Effect of Topical Administration of Nitroglycerin and Lidocaine Versus Lidocaine Alone of the Radial Artery Diameter
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The radial artery, which is located on the outer side of the forearm, can be used in
      interventional procedures, such as cardiac catheterization, to provide access to the arterial
      blood supply. In order to facilitate successful catheterization of the artery, a dilated
      artery and one free of arterial spasm is desirable. The proposed study will randomize twenty
      three healthy subjects in 2 visits to determine the effect of topical nitroglycerin on radial
      artery vasodilation. Radial artery diameter will be measured with ultrasound at regular
      intervals up to two hours.
    

Detailed description: 
      During the first study visit, as a dose-optimizing study, each subject will be randomly
      assigned to one of two Dose-Test arms to receive either 15mg or 30mg of nitroglycerin on one
      wrist and placebo on the other. Radial artery diameter will be measured with ultrasound at
      regular intervals up to two hours. On the second study visit, the same participants will be
      randomly assigned to one of two Combination-Test arms to receive bilateral topical
      application of either 20mg or 40mg of lidocaine; the lidocaine will be applied in combination
      with 30mg of nitroglycerin on one wrist and in combination with placebo on the other wrist.
      Measurements of radial artery diameter will be performed as in the first visit.
    

Intervention name(s): Nitroglycerin 15mg; Nitroglycerin 30mg; Lidocaine 20mg; Lidocaine 40mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 15mg Nitroglycerin applied topically to one wrist; 30mg Nitroglycerin applied topically to one wrist; 20mg Lidocaine applied topically to one wrist in combination with nitroglycerin or placebo; 40mg Lidocaine applied topically to one wrist in combination with nitroglycerin or placebo; Topical skin moisturizing cream with same appearance as active agent
Other intervention name(s): skin moisturizing cream
Intervention MeSH terms: Lidocaine; Nitroglycerin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: To determine if topical nitroglycerin acts to vasodilate the radial artery by a direct local action, or by systemic vasodilation; To determine if topical nitroglycerin dilates the radial artery in the presence of local anesthetic agents used in cardiac catheterization
Baclofen in the Treatment of Alcohol Dependence With or Without Alcoholic Liver Disease
Condition: Alcoholic Liver Disease; Alcohol Dependence
MeSH terms: Liver Diseases; Liver Diseases, Alcoholic; Alcoholism
Study type: Interventional
Phase: Phase 3

Summary: 
      To explore the effectiveness and biobehavioural basis of baclofen in improving treatment
      outcomes for alcohol dependence in people with or without alcoholic cirrhosis in a
      double-blind randomised placebo-controlled trial.
    

Detailed description: 
      This is a double-blind randomised placebo-controlled study investigating the efficacy of
      baclofen for the treatment of alcohol dependence in patients with alcoholic liver disease.
      Medications will be given for 12 weeks, with a further 6 months follow-up. Both male and
      female participants will be recruited to this study. Trial patients will be randomised to one
      of three treatment groups: (1) baclofen 30mg/day (10 mg t.i.d), (2) baclofen 75mg/day (25 mg
      t.i.d) or (3) Placebo (3 matched tabs/day).

      This study will also include a second, parallel group of patients with alcohol dependence
      (non alcoholic-liver disease patients) that will undergo the trial protocol as described
      above. These patients will be randomised according to a separate list into one of three
      treatment groups: (1) baclofen 30mg/day (10 mg t.i.d), (2) baclofen 75mg/day (25 mg t.i.d) or
      (3) Placebo (3 matched tabs/day).
    

Intervention name(s): Baclofen 30mg/day; Baclofen 75mg/day; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 30mg/day 10 mg t.i.d; 75mg/day 25 mg t.i.d; Placebo 3 matched tabs/day
Intervention MeSH terms: Baclofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Repeat Nasal Allergen Challenge
Condition: Hayfever
MeSH terms: Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a non-drug, biomarker study to assess the utility of the model of repeated nasal
      allergen challenges in subjects with atopic rhinitis as a method of inducing an increased
      response to inhaled allergen, which will more closely resemble the responses seen during the
      hayfever season.
    

Detailed description: 
      This is a non-drug, biomarker study to assess the utility of the model of repeated nasal
      allergen challenges in subjects with atopic rhinitis as a method of inducing an increased
      response to inhaled allergen, which will more closely resemble the responses seen during the
      hayfever season.
    

Intervention name(s): Skin Prick Test; Nasal allergen challenge; Nasal filter paper placement; Nasal lavage; Nasal scrape; Nasal symptoms score
Intervention type(s): Procedure; Procedure; Procedure; Procedure; Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Nasal allergen challenge; Allergic rhinitis; Timothy grass pollen; inflammatory mediators
School Gardens and Physical Activity
Condition: Physical Activity
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether school gardens affect children's physical
      activity.
    

Detailed description: 
      New York State schools were randomly assigned to receive school gardens and associated
      curriculum or to serve on the wait list control group that received gardens and curriculum at
      the end of the 2-year study. Baseline data were collected in Fall 2011. Garden interventions
      began in Spring 2012. Follow-up data were collected at 6, 12, 18 months following baseline
      data collection.
    

Intervention name(s): garden
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: physical activity; children; school; garden
Treatment of Bilateral Maxillofacial Post-traumatic Deformities
Condition: Therapeutics of Bilateral Maxillofacial Injuries
MeSH terms: Maxillofacial Injuries
Study type: Observational

Summary: 
      Combined application of surgery planning software and rapid prototyping technology and
      preshaped titanium plates can effectively promote the accuracy of the diagnosis and treatment
      of bilateral maxillofacial post traumatic deformities, reduce operation time and improve
      surgical effect.
    

Detailed description: 
      All patients underwent preoperative CT scan. Firstly, SurgiCase were used to analyze CT data
      and design preliminary surgery plans. Secondly, three-dimensions resin skull models were
      produced by rapid prototyping technology. Model surgeries were performed to determine the
      location, reduction direction and shift distance of osteotomy. Based on the surgical
      simulation, the preliminary surgery plans were validated and optimized. Then, the titanium
      plates and mesh were preshaped on the models. Finally, according to the final surgery plans
      the operations were performed. The operation time, therapeutic effects and complications were
      observed. The follow-up periods were 1-12 months.
    

Intervention name(s): rapid prototyping technology
Intervention type(s): Procedure
Intervention description(s): Rapid prototyping technology was applied in treatment of bilateral maxillofacial post-traumatic deformities
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        patients with Bilateral maxillofacial Post-traumatic Deformities
Study of Safety and Efficacy of a rhPTH[1-84] of Fixed Doses of 25 and 50 mcg in Adults With Hypoparathyroidism (RELAY)
Condition: Hypoparathyroidism
MeSH terms: Hypoparathyroidism
Study type: Interventional
Phase: Phase 3

Summary: 
      Use of PTH (1-84) a recombinant hormone in 25 µg or 50 µg doses for the treatment of adults
      with hypoparathyroidism. The use of PTH (1-84) should result in a decrease of calcium and
      vitamin D supplements.
    

Detailed description: 
      Patients with a history of Hypoparathyroidism will be randomized to receive study drug for 8
      weeks, which will be injected daily in either thigh. During that time they will be monitored
      for safety (specifically calcium levels in blood or urine). In addition, the patients' intake
      of Vitamin D and Calcium will be measured.
    

Intervention name(s): NPSP558
Intervention type(s): Drug
Intervention description(s): All patients will inject NPSP558 25 or 50 µg SC QD into alternating thighs in the morning via a multidose injection pen device.
Other intervention name(s): RELAY
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hypoparathyroidism, rhPTH[1-84], NPSP558
HA35 Treatment the Gingival Discomfort as Well as Gingival Redness and Bleeding of Patients With Periodontitis
Condition: Periodontitis
MeSH terms: Periodontitis; Erythema; Hemorrhage
Study type: Interventional

Summary: 
      The main objective of this study is to research the treatment of 35 kDa hyaluronan fragment
      HA35 for Mild periodontitis and associated with gingival discomfort or itchiness.
    

Detailed description: 
      In this study, tissue permeable 35 kDa low molecular hyaluronan fragment HA35 was freshly
      manufactured using pharmaceutical grade hyaluronidase PH20 injection (State Drug
      Administration H31022111) and joint cavity HA injection (State Drug Administration H20174089)
      mixed at room temperature for 20 min.

      In this study, 20 patients, 8 males, and 12 females, with a mean age of 47±15 years, were
      selected from the outpatient clinic of the Department of Dentistry. All had mild
      periodontitis and were associated with gingival discomfort or itchiness. Injection treatment
      was performed using freshly manufactured 35 kDa hyaluronan fragment HA35. The study was an
      open-label clinical trial in which no information was withheld from the participating
      investigators. A pre- and post-treatment controlled study approach was used, whereby the
      investigator injected 35kDa hyaluronan fragment HA35 into the periodontal pocket in a single
      dose of 100 mg. The distribution of injection amount was determined by the location of
      gingival inflammation. The clinical effects of gingival discomfort or itching, redness and
      swelling, and bleeding from the probing were observed and recorded in patients before and
      after 7 days of treatment.
    

Intervention name(s): HA35(L20200708MP07707, Ministry of Health, Mongolia) was freshly manufactured by mixing hyaluronidase PH20 injectable solution (H31022111) and high-molecular-weight HA injectable solution (H20174089)
Intervention type(s): Drug
Intervention description(s): The clinical effects of gingival discomfort oritching, redness and swelling, and bleeding from the probing were observed and recorded in patients before and after 7 days of treatment.
Other intervention name(s): HA35
Intervention MeSH terms: Pharmaceutical Solutions
Intervention model: Single Group Assignment
Intervention model description: an open-label, single-arm clinical study comparing pre- and post-treatment effects
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: 35 kDa low molecular hyaluronan fragment; HA35; Tissue permeability; Intra-pocket injection; Gingival redness and bleeding
Comprehensive Versus Traditional Lifestyle Program
Condition: Obesity; Physical Fitness; Cognitive Function 1, Social
Study type: Interventional

Summary: 
      Despite recommends that school-based interventions use a comprehensive approach for health
      promotions; most fitness programs exclusively emphasize physical activity. This study
      compared the comprehensive Translational Health in Nutrition and Kinesiology (THINK) program
      to a traditional YMCA program (The Sports, Play, and Active Recreation for Kids (SPARK)
      fitness curriculum) on measures of physical fitness, body composition, and executive
      cognitive function outcomes among 105 ethnic minority children (9±1.03 years old) following a
      10-week intervention period.
    

Detailed description: 
      Despite recommendations that school-based interventions use a comprehensive approaches for
      health promotions; most fitness programs exclusively emphasize physical activity. This study
      compared the comprehensive Translational Health in Nutrition and Kinesiology (THINK) program
      to a traditional YMCA program (The Sports, Play, and Active Recreation for Kids (SPARK)
      fitness curriculum) on measures of physical fitness, body composition, and executive
      cognitive function outcomes among 105 predominantly, ethnic minority children (9±1.03 years
      old) following a 10week intervention period.
    

Intervention name(s): THINK; SPARK
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The THINK curriculum was based on the principles of exercise physiology and health behaviors. Sessions included educational components, concentrating on physiology, nutrition, laboratory experiences, and structured physical fitness activities.; traditional YMCA program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Physical Fitness; Body Composition; Executive Cognitive Function
Safety and Effectiveness Study of The Swedish Adjustable Gastric Band (SAGB) in the Treatment of Morbid Obesity
Condition: Obesity, Morbid
MeSH terms: Obesity; Obesity, Morbid
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether the Swedish Adjustable Gastric Band (SAGB)
      is safe, and effective in achieving weight loss in patients with Morbid Obesity.
    

Detailed description: 
      Surgical treatment of morbidly obese patients is considered a reasonable option for achieving
      weight loss when more conservative measures, such as diet and exercise have failed. Not only
      can weight loss be achieved, but also reduction / resolution of a patient's co-morbidities
      associated with excess weight. Adjustable gastric banding provides a less invasive,
      reversible bariatric surgery option. The SAGB has been commercially available outside the
      United States for this indication since 1996. Commercial availability has led to extensive
      literature supporting the safety and effectiveness of the SAGB. Given the available
      literature, a prospective, single arm, multicenter, study in a heterogeneous population of
      morbidly obese subjects in the U.S. is being conducted.
    

Intervention name(s): Swedish Adjustable Gastric Band
Intervention type(s): Device
Intervention description(s): Long term implantable device.
Other intervention name(s): Realize Band
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity, Morbid; Obesity; Body Weight
Target Heart Rate and Aerobic Interval Training
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      Aerobic interval training is shown to be superior in increasing oxygen uptake in both healthy
      and patients with coronary artery disease (CAD), compared to moderate continuous training.
      However, in cardiac rehabilitation exercise groups, exercise intensity is usually controlled
      with perceived exertion (Borg scale). The investigators will investigate degree of agreement
      between target heart rate and perceived exertion during interval training in cardiac
      rehabilitation.
    


Intervention name(s): Rate of perceived exertion; Heart rate monitor
Intervention type(s): Other; Other
Intervention description(s): Exercise intensity controlled by Borg scale; Exercise intensity controlled by heart rate monitors
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: exercise intensity; aerobic interval training; cardiac rehabilitation; group exercise