bioihbjkbjnl/mcl2 huggingface dataset:
An Evaluation of a Culturally- and Linguistically-Appropriate Online Diet Program for U.S Hispanics
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to conduct a randomized trial to rigorously test the efficacy of
      the MiDieta eHealth portal for weight loss among overweight, though otherwise healthy,
      members of the Hispanic community, many of whom may be members of collaborating managed care
      organizations.
    

Detailed description: 
      Obesity is a major and growing problem among U.S. Hispanics with serious implications for
      diabetes and other chronic disease risks. Current trends among youth suggest that disparities
      in obesity between minorities and non-Hispanic whites will amplify. Reducing such health
      disparities is a priority for federal, state and local governmental bodies and communities.
      Attaining these objectives will require interventions that are culturally- and linguistically
      appropriate. U.S. healthcare providers, however, have few culturally-appropriate tools and
      inadequate numbers of bilingual, trained healthcare professionals to address these
      challenges.

      A culturally-appropriate weight-management portal, supported by bilingual Latina dietitians
      available for remote email counseling, offers an attractive mechanism for efficiently serving
      the underserved. MiDieta/MyDiet is the leading online diet, fitness and weight management
      portal for U.S. Hispanic/Latinos. MiDieta is bilingual (Spanish/English), based on Latino
      foods & habits and already available through dozens of media, hospital, and health plan
      websites. Thousands of Hispanics access MiDieta each week. Tommy Thompson recently selected
      MiDieta as one of the "20 most innovative health promotion and disease prevention
      applications" in the U.S.
    

Intervention name(s): Online MiDieta Diet and Weight Management Program for Hispanics
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Prevention
Keywords: Obesity; Overweight; Hispanics; Online; Weight Loss
First-in-Human Study of CLS003 ICVT in Subjects With Cutaneous Warts
Condition: Cutaneous Warts
MeSH terms: Warts
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This phase I/IIa study has an open-label, First-in-Human (FIH), single center design to
      assess the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses of
      topically applied CLS003 in healthy subjects with cutaneous warts.
    


Intervention name(s): CLS003
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: safety; pharmacokinetics (PK); pharmacodynamics (PD); CLS003
Multimodal Analgesic Protocol to Moderate Acute Pain
Condition: Pain, Post-operative
MeSH terms: Acute Pain; Pain, Postoperative
Study type: Observational

Summary: 
      With a prospective, observational study assess post-surgery pain levels and patient's use of
      opioids and other analgesic drugs to moderate pain following third molar surgery.
    

Detailed description: 
      SPECIFIC AIMS Using the UNC surgery clinic multi-modal protocol of drugs/dosages to control
      acute pain after third molar surgery assess each post-surgery day(PSD) the patient reported

        1. pain levels post-surgery as recorded by Likert-type and Gracely scales

        2. quality of life(QOL) outcomes for lifestyle and oral function

        3. number of opioid doses taken by subject-patients

        4. number of NSAID and acetaminophen doses taken by subject-patients.
    

Intervention name(s): third molar surgery
Intervention type(s): Procedure
Intervention description(s): The patient is asked to complete the diary each post-surgery day for 14 days. Recovery is organized into three QOL domains: lifestyle, oral function, and pain.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients scheduled for surgery at UNC oral and maxillofacial surgery clinic
Alternate-Day Buprenorphine Administration. Phase IV - 5
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if three times a subject's daily maintenance dose
      will hold for 72 hours without changes in agonist and antagonist effects.
    


Intervention name(s): Buprenorphine
Intervention type(s): Drug
Intervention MeSH terms: Buprenorphine
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Westlake N-of-1 Trials for Macronutrient Intake 2 ( WE-MACNUTR 2)
Condition: Postprandial Hyperglycemia; Metabolic Disorder, Glucose
MeSH terms: Hyperglycemia; Metabolic Diseases; Glucose Metabolism Disorders
Study type: Interventional

Summary: 
      Diet and nutrition are key to maintain human health. Westlake N-of-1 Trials for Macronutrient
      Intake (WE-MACNUTR) trial investigates individualized postprandial glycemic responses to
      different proportions of dietary fat and carbohydrates intake using an n-of-1 experimental
      study design. The experimental diets are isocaloric high fat, low carbohydrate (HF-LC) or low
      fat, high carbohydrate (LF-HC). With standardized intervention and strictly controlled eating
      behaviors, the WE-MACNUTR study identifies specific HC-responders and HF-responders in terms
      of postprandial glucose response.

      This is a follow-up study offered to participants who have completed the WE-MACNUTR study in
      2019. Volunteers will be asked to participate in four 5-d periods while wearing glucose
      monitors (Abbott Freestyle Libre) with the following experimental sequence: 1) a washout
      diet, 2) HF-LC or LC-HF diet, 3) a washout diet, 4) HF-LC or LC-HF diet. The experimental
      diet will be randomly assigned. Participants will be asked to provide a fasted blood sample
      and to collect fecal, urine and saliva samples at each visits.
    

Detailed description: 
      This study is a two arm dietary intervention study. Participants will be recruited from the
      WE-MACNUTR study based on the defined inclusion and exclusion criteria. The study duration
      will last up to 21 days.

      Volunteers will be asked to participate in four 5-day periods while wearing glucose monitors
      (Abbott Freestyle Libre) with the following experimental sequence: 1) a washout diet, 2)
      HF-LC or LC-HF diet, 3) a washout diet, 4) HF-LC or LC-HF diet. The experimental diet will be
      randomly assigned.

      Participants will enter the study on a usual (washout) diet and will have a 5-day run in
      period for baseline data collection. Participants will be asked to follow dietary guidance
      and consumed a healthy and balanced diet during this period.
    

Intervention name(s): High fat, low carbohydrate diet; Low fat, high carbohydrate diet
Intervention type(s): Other; Other
Intervention description(s): Throughout the 5-day intervention, participants are provided with a high fat, low carbohydrate (HF-LC) diet in which the percentage of fat, protein and carbohydrate is 60%, 15% and 25%, respectively.; Throughout the 5-day intervention, participants are provided with a low fat, high carbohydrate (LF-HC) diet in which the percentage of fat, protein and carbohydrate is 10%, 15% and 75%, respectively.
Other intervention name(s): HF-LC; LF-HC
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Personalized Nutrition; Glucose Metabolism; Gut Microbiota
Novel Equations for Estimating Lean Body Mass in Patients With Chronic Kidney Disease
Condition: Lean Body Mass; Chronic Kidney Diseases
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Observational

Summary: 
      Simplified methods to estimate lean body mass (LBM), an important nutritional measure
      representing muscle mass and somatic protein, are lacking in non-dialyzed patients with
      chronic kidney disease (CKD).

      Objective: We developed and tested a reliable equations for estimation of LBM in daily
      clinical practice.
    

Detailed description: 
      Two cross-sectional data sets were derived from outpatients with CKD stage 3-5 in Peking
      University First Hospital.Two equations for estimating LBM based on midarm muscle
      circumference (MAMC) or hand grip strength (HGS)were developed and validated in CKD patients
      with dual-energy x-ray absorptiometry (DEXA) as referenced gold method. Demographic data,
      comorbidity, and other clinical variables were also recorded.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The development and validation groups both included 150 non-dialyzed patients with CKD
        stage 3-5.
      
Keywords: mid-arm muscle circumference; handgrip strength; dual-energy x-ray absorptiometry
Sequential Inactivated Poliomyelitis Vaccine Followed by Oral Poliomyelitis Vaccine Versus Oral Poliomyelitis Vaccine
Condition: Polio; Poliomyelitis
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to generate data to support the registration extension of IMOVAX
      Polio to be used in a sequential vaccination.

      Primary objective:

        -  To demonstrate the non-inferiority of Inactivated Poliomyelitis Vaccine (IPV)-(Oral
           Poliomyelitis Vaccine) (OPV)-OPV (Sequential 1) and IPV-IPV-OPV (sequential 2)
           poliovirus vaccine administrations versus OPV-OPV-OPV (Reference) in terms of
           seroprotection rate 28 to 42 days after the third dose of the primary vaccination
           series.

      Secondary objectives:

        -  To evaluate the safety profile of the investigational vaccines after each administration
           in each group.

        -  To describe the humoral immune response to poliovirus serotypes (types 1, 2 and 3)
           before the first dose and 28 to 42 days after the third primary series dose of vaccine
           in each group.

        -  To describe the persistence of antibodies against poliovirus serotypes (types 1, 2 and
           3) after the third primary series dose administration, at 18 months of age in each
           group.
    

Detailed description: 
      Study participants will be randomized to receive either 3 doses of a commercially available
      Oral Poliovirus Vaccine (OPV), or 1 dose of Sanofi Pasteur's injectable Inactivated
      Poliovirus Vaccine IMOVAX Polio (IPV) followed by 2 doses of OPV, or 2 doses of IPV followed
      by 1 dose of OPV.

      These vaccines will be administered at 2, 3 and 4 months of age as primary vaccination for
      the prevention of poliomyelitis. Participants will be followed up through their 18th- to
      19th-month birthday.
    

Intervention name(s): Injectable inactivated types 1, 2 and 3 poliovirus + Live oral Polio; Injectable inactivated types 1, 2 and 3 poliovirus + Live oral Polio; Live oral poliovirus type 1, 2 and 3
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular + 1g dragee candy oral dose; 0.5 mL, Intramuscular + 1g dragee candy oral dose; 1g dragee candy, oral
Other intervention name(s): IMOVAX Polio®; IMOVAX Polio®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Polio; Poliovirus; Oral poliovirus vaccine; IMOVAX Polio®
ORN Study: Curative Treatment of Osteoradionecrosis (ORN) With Hybrid Bone Substitution
Condition: Mandible; Osteoradionecrosis
MeSH terms: Osteoradionecrosis
Study type: Interventional

Summary: 
      The main objective of the study is the cure of osteoradionecrosis (ORN) at 12 months.
    


Intervention name(s): Hybrid bone substitution
Intervention type(s): Procedure
Intervention description(s): The patient will be treated by hybrid bone substitution with calcium-phosphate ceramic biomaterial and autologous bone marrow after necrosis exeresis
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mandibular osteoradionecrosis; hybrid bone substitution; calcium-phosphate ceramic biomaterial; autologous bone marrow
Distant Management of Crohn's Disease by Smartphones is Feasible and Effective Additionally it Reduces the Costs
Condition: Crohn Disease
MeSH terms: Crohn Disease
Study type: Interventional

Summary: 
      Evaluation of the feasibility, acceptability, patient satisfaction and economic benefits of
      smartphone video-based telehealth in the management of Crohn's disease patients
    

Detailed description: 
      Patients were examined by two gastroenterologists (HY, AED) either at a video conference
      based visit or face to face visit in outpatients clinics. We used the WhatsApp business
      application.The online visit notion was the same as traditional face-to-face visit except
      physical examination.
    

Intervention name(s): real time online video visit
Intervention type(s): Other
Intervention description(s): Participants have received an online visit by a smartphone application
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Dose-finding Study of Four Dosage Levels of an H7N9 Influenza Vaccine in Adults Between Ages of 18 Years and 65 Years
Condition: H7N9 Influenza
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluate the safety and immunogenicity of four different doses of H7N9 vaccination in adults
      between the ages of 18 years and 65 years.
    


Intervention name(s): H7N9c low dose with adjuvant; H7N9c medium dose with adjuvant; H7N9c high dose with adjuvant; H7N9c high dose without adjuvant
Intervention type(s): Biological; Biological; Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Influenza, H7N9, Vaccine
Capsaicin on Salty Gustatory Cortices
Condition: Volunteers
Study type: Interventional
Phase: Phase 4

Summary: 
      Excess dietary salt intake is closely associated with the development of hypertension and
      cardiocerebral vascular diseases. Preference of high salt diet might involve salty gustatory
      cortices change. This study focuses on examining the neuroimaging changes of salty gustatory
      cortices under different concentration of NaCl solution with or without capsaicin
      intervention through brain PET/CT scan.
    

Detailed description: 
      Hypertension and its related complications are common health problems that can lead to
      multiple organ damage and death. Excessive salt intake plays an important role in the
      development of hypertension.

      The experimental design is a randomized, double-blind, interventional study to investigate
      the neuroimaging changes of salty gustatory cortices under different concentration of NaCl
      solution with or without capsaicin intervention through brain PET/CT scan.
    

Intervention name(s): Capsaicin; NaCl
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Capsaicin in the concentration of 0.5 µmol/L was mixed in the test solutions in Capsaicin_effect subgroups; NaCl in various concentrations was desorved in the test solutions in Salt_effect subgroups
Intervention MeSH terms: Capsaicin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Ulcerative Colitis Study: Study of Visilizumab in Patients With Severe Ulcerative Colitis
Condition: Severe Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of visilizumab in
      patients with severe ulcerative colitis that has failed to respond to steroid therapy.

      What is visilizumab?

      Visilizumab is an antibody designed to reduce inflammation. Antibodies are proteins that are
      normally made by the immune system to help defend the body from infections and other foreign
      substances. Visilizumab is thought to selectively affect the immune system to decrease
      inflammation and, in doing so, it may prevent damage to the intestine caused by ulcerative
      colitis.

      Who can participate in this study?

      The target population for this study is adults with severe ulcerative colitis that has
      resisted intravenous (IV) steroids. This study is open to patients with the following
      characteristics:

        -  16-70 year olds

        -  A diagnosis of ulcerative colitis verified by colonoscopy or barium enema performed
           within 36 months prior to study entry

        -  Active disease despite ongoing treatment with steroids

      How is this study conducted?

      Eligible participants will be administered visilizumab as one daily injection on two
      consecutive days. All medication and study-related care, except for the costs of in-patient
      hospitalization, are provided to qualified participants at no cost. This includes all visits,
      examinations and laboratory work.

      How does one get more information?

      This study is currently enrolling patients at hospitals and clinics in North America and
      Europe. For more information on the study or how to participate in it, please call
      1-800-772-0482, email InfoCenter@pdl.com or visit www.IBDtrials.com.
    

Detailed description: 
      PDL BioPharma, Inc. was formerly known as Protein Design Labs, Inc.
    

Intervention name(s): Visilizumab
Intervention type(s): Drug
Intervention MeSH terms: Visilizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Eszopiclone for the Treatment of Posttraumatic Stress Disorder
Condition: Posttraumatic Stress Disorders
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if eszopiclone relative to placebo (sugar pill) is
      effective and tolerable for people with posttraumatic stress disorder (PTSD)-related sleep
      disturbance. The investigators will also examine the impact of treatment on sleep patterns,
      memory recall bias, and level of inflammatory markers (cytokines). The investigators predict
      eszopiclone will lead to greater improvement than placebo in measures of PTSD symptoms,
      memory recall bias, and level of inflammatory markers.
    


Intervention name(s): Eszopiclone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Eszopiclone has been approved by the US Food and Drug Administration (FDA) for the treatment of insomnia (inability to sleep). Eszopiclone has not been specifically approved by the FDA for people who have PTSD-related sleep disturbance.; The placebo used in this study looks exactly like eszopiclone but contains no active ingredients.
Other intervention name(s): Lunesta®
Intervention MeSH terms: Eszopiclone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Post-traumatic stress disorder; sleep disturbance; insomnia; cytokines; anxiety; traumatic event; memory
Targeted Biopsy of Carbon Nanoparticles Labelled Axillary Node for cN+ Breast Cancer
Condition: Location and Biopsy of Axillary Lymph Nodes
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      To explore the feasibility of target biopsy of carbon nanoparticles labelled lymph node after
      neoadjuvant systemic therapy for cN+ breast cancer, and evaluate whether it can accurately
      predict axillary lymph node status after neoadjuvant systemic therapy.
    

Detailed description: 
      Locally advanced breast cancer patients with clinical assessed positive axillary lymph node
      (cN+) who receive neoadjuvant systemic therapy (NST) will be enrolled in this study. Before
      NST, one of the suspected lymph nodes will be subjected to ultrasound-guided core needle
      biopsy (CNB) or fine needle aspiration (FNA), and a locating clip will be placed. Meanwhile,
      a small amount of Kanarine (Carbon Nanoparticles Suspension Injection) will be injected into
      or around the cortex of the locating lymph node as well as other positive lymph nodes. All
      patients will be confirmed to have axillary lymph node metastasis by pathologic or cytologic
      examination. After NST, FNA will be performed again for the lymph nodes labelled with
      previous locating clip. During the operation, the clip labelled lymph nodes were identified
      with carbon and sent to pathology separately. Meanwhile, the remaining carbon labelled lymph
      nodes were also separately examined. Axillary lymph node dissection will be performed in all
      patients. The detection rate of labelled lymph node will be record, and the pathological
      results of re-FNA of labelled lymph nodes will be compared with postoperative pathological
      results. Meanwhile, we will also analysis whether carbon labelled lymph node biopsy could
      predict the overall status of axillary lymph nodes after NST.
    

Intervention name(s): Carbon nanoparticles suspension injection will be injected into or around the cortex of the clinically assessed positive lymph nodes
Intervention type(s): Drug
Intervention description(s): Before NST, one of the clinically assesed positive lymph nodes will be subjected to ultrasound-guided CNB or FNA, and a locating clip (Ultraclip, BARD) will be placed. Meanwhile, a small amount of Kanarine (carbon nanoparticles suspension injection, 0.5ml:25mg, H20073246) will be injected into or around the cortex of the locating lymph node and other clinically assessed positive lymph nodes. Preoperative FNA will be performed again for locating clip labelled node.
Other intervention name(s): A locating clip was placed in one of the suspected lymph nodes; Preoperative FNA will be performed again for locating clip labelled node
Intervention MeSH terms: Adrenocorticotropic Hormone; Melanocyte-Stimulating Hormones; beta-Endorphin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Breast cancer; neoadjuvant chemotherapy; Axillary lymph nodes positive; Carbon-tattooed Lymph Nodes; locating clip