bioihbjkbjnl/mcl2 huggingface dataset:
The Natural History of Wheat Hypersensitivity in Thai Children
Condition: Wheat Allergy; Child
MeSH terms: Hypersensitivity; Wheat Hypersensitivity
Study type: Interventional

Summary: 
      Wheat allergy is affected 0.4-1% and is a major staple of the worldwide diet. Wheat avoidance
      is exceedingly difficult and imposes major dietary restriction. The purpose of this study
      were to determine the rate of oral tolerance and identify clinical and laboratory predictors
      of tolerance development in Thai children who allergic to wheat.
    

Detailed description: 
      All children in this study were sensitized to wheat. Each patient was clinically evaluated,
      with focus on wheat allergy by both a detailed medical examination and collection of medical
      history. Blood sample was taken for baseline determination of ImmunoglobulinE antibodies to
      wheat and to omega-5-gliadin. The oral wheat challenge were performed in all study subjects
      to identify a case of wheat outgrowing. The primary outcome was the development of oral
      tolerance to wheat. Oral wheat challenge were generally performed at least every 1 years if
      the child did not have an interval history of symptoms with unintentional exposure.
    

Intervention name(s): oral wheat challenge
Intervention type(s): Dietary Supplement
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: wheat allergy; wheat outgrowing; wheat hypersensitivity; omega-5-gliadin; natural history of wheat hypersensitivity
Myrcludex B vs Entecavir in Patients With HBeAg Negative Chronic Hepatitis B
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A randomized, open-label multicentre clinical trial of daily Myrcludex B versus entecavir in
      patients with HBeAg negative chronic hepatitis B.
    

Detailed description: 
      This is a randomized, open-label multicentre clinical trial of daily Myrcludex B versus
      entecavir in patients with HBeAg negative chronic hepatitis B. Accounting for screen-outs
      about 76 patients will be screened and 48 of them will be randomized into 6 treatment groups:

      Arm A (8 patients): Myrcludex B 0.5 mg / day / sc / 12 weeks Arm B (8 patients): Myrcludex B
      1 mg / day / sc / 12 weeks Arm C (8 patients): Myrcludex B 2 mg / day / sc / 12 weeks Arm D
      (8 patients): Entecavir 0.5 mg / day / orally / 24 weeks Arm E (8 patients): Myrcludex B 5 mg
      / day / sc / 12 weeks Arm F (8 patients): Myrcludex B 10 mg / day / sc / 24 weeks

      The study consists of screening period up to 28 days (Day -28 -1); baseline visit (Day 0),
      treatment period up to 12 weeks for groups A-C, E and 24 weeks for groups D, F; follow-up
      period up to 12 weeks for groups A-C, E, F.
    

Intervention name(s): Entecavir; Myrcludex B
Intervention type(s): Drug; Drug
Other intervention name(s): Baraclude®; Myrcludex
Intervention MeSH terms: Entecavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Clinical Study to Assess the Safety and Effectiveness of Anti-Ageing and Skin Brightening Gel
Condition: Wrinkle; Pigment Skin; Aging
MeSH terms: Pigmentation Disorders
Study type: Interventional

Summary: 
      This is a Randomized, Interventional, Prospective, Double Blind, Two Arm, Comparative,
      Parallel, Placebo-Controlled, Safety and Efficacy Study of Anti-Ageing and Skin Brightening
      Gel.

      Total of 44 adult female subjects (22 Subjects/Arm) of age 35 - 55 years will be enrolled to
      get 40 completed subjects (20 Subjects/Arm)
    

Detailed description: 
      There will be a total of 3 visits in the study. The subject will be instructed to visit the
      facility as per the below visits Visit 01 (Day 01): Screening, Enrolment and Treatment Start
      Phase (Week 00) Visit 02 (Day 30): Treatment Phase (Week 04) Visit 03 (Day 60): End of Study
      (Week 08) The potential subjects will be screened as per the inclusion and exclusion criteria
      only after obtaining written informed consent. Subjects will be asked to not wear any makeup
      on the face on screening day.

      Assessment of efficacy parameters before test products usage will be done on Day 01 after
      enrolment and after test products usage will be done on Day 30 (± 2 days) and Day 60 (± 2
      days) as listed-below.

        -  PGA scoring using Griffiths scale - skin dryness, redness, fine wrinkling/lines, coarse
           wrinkling/lines, laxity, roughness and sallowness.

        -  Glogau skin age.

        -  Skin pigmentation scoring.

        -  Skin elasticity: Cutometer Dual MPA 580.

        -  Skin colorimeter CL 400: CIE L*, a* b*, ITA angle, skin brightness, skin pigmentation
           reduction.

        -  Skin Glossymeter GL200 - skin glow.

        -  Visioscan (C+K instrument): crow's feet area wrinkles, fine lines, skin texture -
           roughness, dryness, wrinkles, smoothness.

        -  Digital photographs: facial photographs before test products usage on day 1 and
           post-usage at day 60.

        -  Image-pro software - image analysis day 01 vs day 60 - wrinkles, fine lines, pores.

        -  Subjective product perception assessment regarding the test product's effect on skin
           firmness, appearance, radiance, acne or skin breakouts, glowing skin tone, blemishes and
           dark skin patches removal etc.
    

Intervention name(s): Placebo; Anti-Ageing and Skin Brightening Gel
Intervention type(s): Other; Other
Intervention description(s): Placebo Comparator; Anti-Ageing and Skin Brightening Gel.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a Randomized, Interventional, Prospective, Double Blind, Two Arm, Comparative, Parallel, Placebo-Controlled, Safety and Efficacy Study
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Phase 3 Evaluation of the Safety and Efficacy of LNZ101 for the Treatment of Presbyopia
Condition: Presbyopia; Refractive Error; Near Vision; Miosis; Eye Diseases
MeSH terms: Eye Diseases; Presbyopia; Refractive Errors
Study type: Interventional
Phase: Phase 3

Summary: 
      Phase 3 study to evaluate the safety and effectiveness of LNZ101 for the treatment of
      Presbyopia.
    

Detailed description: 
      Phase 3 study to evaluate the safety and effectiveness of LNZ101 compared with LNZ100 and
      Brimonidine for the treatment of Presbyopia.
    

Intervention name(s): Aceclidine + Brimonidine; Aceclidine; Brimonidine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): LNZ101 (Aceclidine/Brimonidine) ophthalmic solution; LNZ100 Aceclidine ophthalmic solution; Brimonidine ophthalmic solution
Intervention MeSH terms: Brimonidine Tartrate; Aceclidine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A multi-center, double-masked, randomized, active-controlled, safety and efficacy study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pharmaceutical Solutions; Eye Drops; CLARITY; Presbyopia; Ophthalmic Solutions; Miotic
Rotator Cuff Pathway
Condition: Shoulder Pain
MeSH terms: Shoulder Pain
Study type: Interventional

Summary: 
      Rotator cuff surgery is mostly performed on an outpatient basis, and many patients still
      experience moderate to severe pain after surgery, despite the use of regional anesthesia and
      opioids. The specific aim is to determine whether a comprehensive pathway that includes a
      well-defined regional technique and multimodal analgesia will reduce the worst pain with
      movement 0-48 hours after block placement compared to the current standard practice. This is
      a 'before and after' study. We plan to have 70 patients studied prior to initiation of a
      pathway, and 70 patients studied after initiation of a pathway. Both groups will receive
      identical postoperative follow-up.
    

Detailed description: 
      Previous study in shoulder arthroplasty patients demonstrated low pain scores and minimal
      intravenous opioid use when utilizing a clinical pathway that included peripheral nerve block
      and preemptive non-opioid analgesia (Goon et al. 2014). These surgeries were done as
      inpatient and patients had availability of intravenous opioids. Assessment of the current
      approach to managing rotator cuff repairs demonstrated an average worst pain score after
      surgery of 7.0, SD 2.1 (Kahn) which is often categorized as "severe" pain. Given that most
      rotator cuff repairs are done as outpatients, it is important to develop a clinical pathway
      that mitigates the worst pain experienced after surgery. With outpatient surgery, there are
      obvious limitations regarding availability of rescue pain medications. Therefore, the pathway
      needs to emphasize patient education and strategies to reduce the pain as peripheral nerve
      block subsides. Given these issues, we believe there is an advantage to prolonging the
      analgesia from the nerve block (Rosenfeld et al. 2016, Yadeau et al. 2016, Kahn) and
      educating patients regarding the importance of preemptive analgesia and when to take opioid
      medications. This study will evaluate whether the clinical pathway might mitigate the worst
      pain after surgery that occurs with the current standard practice.
    

Intervention name(s): Pathway
Intervention type(s): Other
Intervention description(s): The study team emphasizes that all components of the pathway are considered standard of care at this institution. The objective of this study is to ensure that the study patients assigned to the pathway will receive these standard of care components. Both groups will receive identical postoperative follow-up.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Clinical Study to Compare the Pharmacokinetics and Safety of Ramucirumab Injection With Cyramza ® in Healthy Male Volunteers
Condition: Gastric Cancer; Non-small Cell Lung Cancer; Colo-rectal Cancer
MeSH terms: Carcinoma, Non-Small-Cell Lung; Rectal Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Ramucirumab is a biosimilar drug of CYRAMZA® produced by Chiatai Tianqing Pharmaceutical
      Group Nanjing Shunxin Pharmaceutical Co., LTD. It is a vascular endothelial growth factor
      receptor 2 (VEGFR-2) antagonist. This single-center, randomized, double-blind, single-dose,
      parallel phase I study of Ramucirumab injection versus Cyramza ® in healthy male volunteers
      was designed to evaluate the similarities in pharmacokinetics, tolerance, safety and
      immunogenicity of Ramucirumab and CYRAMZA®.
    


Intervention name(s): Ramucirumab Injection; Ramucirumab Injection [Cyramza]
Intervention type(s): Drug; Drug
Intervention description(s): Ramucirumab injection biosimilar products manufactured by Chia Tai Tianqing Pharmaceutical,; Ramucirumab Injection is a humanized monoclonal antibody based on the human immunoglobulin G1(IgG1) skeleton sequence, developed by Eli Lilly Co., the bran name is Cyramza. Ramucirumab is a vascular endothelial growth factor receptor 2 (VEGFR2) antagonist that specifically binds to VEGF receptor 2 and blocks VEGFR ligand, VEGF-A, VEGF-C, and VEGF-D binding to the receptor. As a result, Ramucirumab inhibits ligand-stimulated VEGF receptor 2 activation, thereby inhibiting ligand-induced proliferation, and human endothelial cell migration. Ramucirumab inhibits angiogenesis, thereby blocking the tumor's blood vessel supply.
Intervention MeSH terms: Ramucirumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
CROSSROAD II: Activating Rural Clinics and Women With Disabilities to Improve Cancer Screening
Condition: Breast Cancer; Cervical Cancer; Colorectal Cancer
MeSH terms: Colorectal Neoplasms; Uterine Cervical Neoplasms
Study type: Observational

Summary: 
      The goal of this project is to develop and pilot test an innovative approach for overcoming
      barriers to cancer screening among women with physical disabilities (WWD) in rural Oregon.
      Many studies have shown that people with disabilities receive fewer indicated cancer
      screening services and are more likely to have poor cancer-related outcomes, such as late
      stage at diagnosis, compared to those without disabilities.
    


Intervention name(s): Clinic Intervention; Patient Intervention
Intervention type(s): Other; Other
Intervention description(s): The Clinic intervention consists of an educational video, an interactive meeting with clinicians and clinic staff, and a facilitated follow-up meeting with clinic staff.; The patient intervention consists of a single 90-minute interactive in-person session.
Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Primary care clinics
Emollient Therapy In Preterm & Low Birth Weight Neonates: A Randomized Clinical Trial
Condition: Weight Gain
MeSH terms: Body Weight; Birth Weight; Weight Gain
Study type: Interventional

Summary: 
      The objective of this study is to assess the impact of emollient therapy on gain in weight
      and length among preterm and low birth weight babies.
    

Detailed description: 
      The study will be conducted at the Department of Pediatric Medicine unit 1, KEMU / Mayo
      Hospital Lahore. Total of 140 neonates fulfilling the eligibility criteria will be enrolled.
      They will be randomly divided into two groups - A and B. Mothers of the neonates in group A
      will be advised massage with sunflower oil while mothers of the neonates in group B will be
      advised massage without any emollient. Babies will closely be followed up and their weight
      and length will be measured at six months of age and will be analyzed using SPSS v 23.0.
    

Intervention name(s): Emollient (sunflower oil)
Intervention type(s): Other
Intervention description(s): In group A, mothers will be advised to massage their babies with sunflower oil at a dose of 10 mL/kg/day twice a day in equally divided amounts. They will be called for follow up after six months of application of sunflower oil.
Intervention MeSH terms: Emollients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Emollient Low birth weight Preterm Weight Length.
Efficacy and Safety of T-817MA in Patients With Mild to Moderate Alzheimer's Disease (US202)
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective is to evaluate the efficacy of T-817MA as measured by ADAS-cog and
      ADCS-CGIC.

      The secondary objectives are:

        -  To evaluate the safety and tolerability of T-817MA measured by clinical safety
           laboratories, physical examinations, ECGs and solicitation of adverse events.

        -  To evaluate the efficacy of T-817MA as measured by ADCS-ADL, FAQ, Neuropsychiatric
           Inventory (NPI) and Mini-mental State Examination (MMSE).
    


Intervention name(s): T-817MA-H; T-817MA-L; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 224 mg or 448 mg T-817 MA once daily; 224 mg T-817 MA once daily; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alzheimer's Disease; Alzheimer's
CCI-779 in Treating Patients With Malignant Glioma
Condition: Brain and Central Nervous System Tumors
MeSH terms: Glioma; Nervous System Neoplasms; Central Nervous System Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die.

      PURPOSE: Phase I/II trial to study the effectiveness of CCI-779 in treating patients who have
      malignant glioma.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the maximum tolerated dose of CCI-779 in patients with malignant glioma.

        -  Determine the safety profile of this drug in these patients.

        -  Determine the pharmacokinetics of this drug in these patients.

        -  Determine the efficacy of this drug, in terms of survival and objective response, in
           these patients.

      OUTLINE: This is a dose-escalation study. Patients in phase II are stratified according to
      use of enzyme-inducing antiepileptic drugs (EIAEDs) (yes vs no) and disease type
      (glioblastoma multiforme with stable neuro-imaging after radiotherapy vs recurrent malignant
      glioma). Patients in phase I must be currently receiving EIAEDs.

        -  Phase I: Patients receive CCI-779 IV over 30 minutes once weekly. Treatment repeats
           every 4 weeks in the absence of disease progression or unacceptable toxicity.

      Cohorts of 3-6 patients receive escalating doses of CCI-779 until the maximum tolerated dose
      (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6
      patients experience dose-limiting toxicity.

        -  Phase II: Patients receive CCI-779 as in Phase I. Patients who are candidates for
           surgical resection of recurrent disease receive CCI-779 IV over 30 minutes 2 hours prior
           to surgery and then once weekly, as above, once recovered from surgery.

      Patients are followed for survival.

      PROJECTED ACCRUAL: A total of 36 patients will be accrued for phase I of this study within 12
      months. A total of 87 patients will be accrued for phase II of this study within 12 months.
    

Intervention name(s): temsirolimus
Intervention type(s): Drug
Intervention MeSH terms: Sirolimus; Temsirolimus; MTOR Inhibitors
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Primary purpose: Treatment
Keywords: recurrent adult brain tumor; adult glioblastoma; adult anaplastic astrocytoma; adult anaplastic oligodendroglioma; adult mixed glioma; adult giant cell glioblastoma; adult gliosarcoma
Effects of Unloader Bracing in Clinical Outcome and Cartilage Physiology Following Microfracture of Chondral Defects
Condition: Cartilage Loss; Microfracture
MeSH terms: Fractures, Stress
Study type: Interventional

Summary: 
      The study will examine clinical and radiographic outcomes of microfracture surgery (a common
      technique to address isolated areas of cartilage loss) in the knee used with or without
      unloader bracing. Randomly selected patients will wear an unloader brace, which is designed
      to take pressure off the area of the knee which underwent repair, for several weeks after
      surgery. Our hypothesis is that bracing may improve clinical and or radiographic outcomes.

      The surgery performed will be the same for all patients

      The length of follow up and schedule of post-operative MRI will be the same for all patients.

      The only difference in groups will be presence of absence of brace wear.
    

Detailed description: 
      The study will examine clinical and radiographic outcomes of microfracture surgery (a common
      technique to address isolated areas of cartilage loss) in the knee used with or without
      unloader bracing. Radiographic outcome will be assessed via MRI scans post-operatively.
      Randomly selected patients will wear an unloader brace, which is designed to take pressure
      off the area of the knee which underwent repair, for several weeks after surgery. Our
      hypothesis is that bracing may improve clinical and or radiographic outcomes.

      The surgery performed will be the same for all patients

      The length of follow up and schedule of post-operative MRI will be the same for all patients.

      The only difference in groups will be presence of absence of brace wear.
    

Intervention name(s): Unloader Bracing; Non-Bracing
Intervention type(s): Device; Device
Intervention description(s): The bracing arm patients will be randomly selected and will wear an unloader brace post-operatively during the study period.; Microfracture performed with no post-operative unloader bracing
Other intervention name(s): Ossur Unloader Brace
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: cartilage; microfracture; knee; bracing
The Effect of Bench-model Training in Cognitive Learning in the Operating Room
Condition: Sensitivity Training Groups
MeSH terms: Hypersensitivity
Study type: Observational

Summary: 
      Based on the motor learning theories, it is hypothesized that bench-model training will allow
      junior residents to be more interactive than trainees lacking similar active hands-on
      training.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Residents enrolled in first or second year from a variety of divisions.
      
Keywords: Orthopedics; bone fixation
Predictors of the Metabolic Effect of Sleep Loss
Condition: Apnea; Obstructive Sleep Apnea (OSA); Obesity
MeSH terms: Apnea; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      To test whether baseline levels of slow wave activity (SWA) during sleep are lower in obese
      adults, and even lower in persons with sleep disordered breathing (SDB) compared to lean
      adults.

      To compare levels of SWA in individuals in relation to their sleep time, blood pressure,
      heart rate, and markers of glucose metabolism.
    


Intervention name(s): Restriction; Extension
Intervention type(s): Other; Other
Intervention description(s): Time in bed for each subject is restricted by two hours per night for 4 nights; Bedtime is extended by 2 hours per night for 4 nights
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Sleep, Apnea, OSA, obese, middle-aged