bioihbjkbjnl/mcl2 huggingface dataset:
GI Biorepository of Tissue and Bodily Fluids
Condition: Gastrointestinal Diseases
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases
Study type: Observational

Summary: 
      The purpose of this study is to establish the working protocols for a general biorepository
      with the specific aim of procuring tissues and bodily fluids from the human gastrointestinal
      tract from a diverse range of clinical patients at the UC Davis Medical Center. The
      establishment of a GI-specific biorepository will support future translational endeavors
      within the UC Davis campus by providing laboratories with readily available GI tissue and
      bodily fluid samples to test newly developed hypotheses with relative ease.
    

Detailed description: 
      UC Davis is currently lacking a general use biorepository for GI tissues and bodily fluids.
      As with any translational research study, the procurement of human tissue samples can be a
      difficult and time- consuming process. The establishment of this biorepository will help
      streamline GI biospecimen collection and centralize these samples in a conveniently located
      space to facilitate the implementation of future unspecified translational studies.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Individuals to be included will be all consenting adults aged 18 years or older with an
        appointment with a healthcare professional in the Division of Gastroenterology or the
        Department of Surgery. During their routinely scheduled appointment or procedure, eligible
        individuals will be informed of the program by the attending physician and encouraged to
        participate in order to establish a diverse collection of samples of GI-related pathologies
        and matched controls. The investigators' exclusion criteria will include minors, pregnant
        women, prisoners, and all other vulnerable populations who are unable to consent.
Effects of Telbivudine and Tenofovir Disoproxil Fumarate Treatment on the Hepatitis B Virus DNA Kinetics in CHB
Condition: Hepatitis B Virus
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the safety, tolerability and effectiveness of 12
      weeks of treatment with telbivudine 600 mg daily plus tenofovir DF 300 mg one daily (OD)
      taken together vs. tenofovir DF 300 mg once daily (QD) or vs telbivudine 600 mg monotherapy
      daily (QD). This is an open labeled, active controlled, viral kinetics study which means the
      subjects and study doctor will know what study drug subjects have been assigned. This study
      is open to male and female subjects, <40 years of age, who have been infected with HBV for at
      least 6 months and have not received oral treatment for HBV.
    


Intervention name(s): Telbivudine; Tenofovir; Telbivudine plus tenofovir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 600 mg monotherapy supplied in film-coated tablets.; Tenofovir disoproxil fumarate was supplied in 300 mg tablets; Telbivudine 600 mg and Tenofovir 300 mg were purchased in commercial packs. Patients were instructed to take medication(s) orally every morning either with or without food.
Intervention MeSH terms: Tenofovir; Telbivudine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic HBV; Asian adult subjects with chronic HBV, in immune tolerant phase, and positive for hepatitis B e antigen (HBeAg)
Monocyte Biomarkers in Moderate to Severe Plaque Psoriasis Subjects Treated With Apremilast
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open label pilot study of the impact of treatment with standard dosing of Otezla
      for 16 weeks on AM-endotype psoriasis patients, identified by elevated (>150% of normal): 1.)
      Intermediate (CD14++CD16+) monocytes, or 2.) circulating monocyte doublets, or 3.)
      circulating monocyte-platelet aggregates (MPA).

      Approximately 25 psoriasis patients with the AM-endotype will be followed during treatment
      over 16 weeks with 4 monthly individual blood draws will be enrolled. All treated psoriasis
      subjects will receive apremilast through Week 16.
    


Intervention name(s): Apremilast
Intervention type(s): Drug
Intervention description(s): Apremilast will be given as approved by the FDA for the treatment of moderate to severe plaque psoriasis. An initial dosage titration from Day 1 (10mg) to Day 5 (30mg). Following the titration, the recommended maintenance dosage of 30 mg twice daily taken orally starting on Day 6 will be dispensed, as per labeled indication.
Other intervention name(s): Otezla
Intervention MeSH terms: Apremilast
Intervention model: Single Group Assignment
Intervention model description: This is an open label pilot study of the impact of treatment with standard dosing of APM for 16 weeks on AM-endotype psoriasis patients, identified by elevated (>150% of normal): 1.) Intermediate (CD14++CD16+) monocytes % of cells in circulation, or 2.) circulating monocyte doublets % of adherent monocyte-monocyte pairs, or 3.) circulating monocyte-platelet aggregates (MPA) % monocytes adherent to platelets.
Masking: None (Open Label)
Primary purpose: Treatment
Patient Navigation for Lung Screening at MGH Community Health Centers
Condition: Lung Cancer
Study type: Interventional

Summary: 
      To develop and implement a patient navigator (PN) program for lung screening and smoking
      cessation in community health center primary care practices. This program will be evaluated
      in a randomized controlled trial of primary care patients who currently smoke.
    

Detailed description: 
      The specific aims of this study are:

      Specific Aim 1: To develop a patient navigator (PN) program for lung screening for patients
      who are current smokers, aged 55-77 years, potentially eligible for lung screening and are
      receiving care at community health centers (CHCs) affiliated with MGH.

      Specific Aim 2: To evaluate the effectiveness of the new lung screening PN program in
      improving screening rates and increasing use of tobacco cessation services in a randomized
      controlled trial.

      Specific Aim 3: To demonstrate that equity is maintained in rates of lung screening and in
      follow up of abnormal chest CT results, comparing eligible smokers from CHCs with eligible
      smokers from other practices within the MGH primary care network.
    

Intervention name(s): Patient Navigation; Usual Care
Intervention type(s): Other; Other
Intervention description(s): One to one patient navigation to obtain lung screening and follow-up of abnormal results, as well as smoking cessation guidance.; Usual care during the study period. After the study period, they will be offered 1:1 patient navigation to obtain lung screening and follow-up of abnormal results, as well as smoking cessation guidance.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Lung Screening; Low-Dose Computer Tomography; Patient Navigation
A Study of LY3454738 in Healthy Participants and Participants With Atopic Dermatitis
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to investigate the safety, tolerability, and efficacy of
      the study drug known as LY3454738 in healthy participants and participants with atopic
      dermatitis. The study has three parts. Each participant will enroll in one part. The study
      will last 12 to 24 weeks, depending on part.
    


Intervention name(s): LY3454738; LY3454738; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered IV; Administered SC; Administered IV
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis
Condition: Postmenopausal Women With Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if treatment is effective in preventing fractures
      in women with postmenopausal osteoporosis.
    

Detailed description: 
      In this trial, women were randomly assigned in a 1:1 ratio to receive monthly subcutaneous
      romosozumab or weekly oral alendronate for 12 months. Randomization was stratified according
      to age (<75 vs. ≥75 years). After completion of the double-blind treatment period, all the
      participants were to receive open-label weekly oral alendronate until the end of the trial,
      with blinding to the initial treatment assignment maintained.

      The primary analysis was performed when clinical fracture events had been confirmed in at
      least 330 participants and all the participants had completed the month 24 visit. The study
      was to continue in an event-driven manner until at least 440 participants experienced a
      nonvertebral fracture or if the superiority of romosozumab was proven for nonvertebral
      fractures at the primary analysis.
    

Intervention name(s): Romosozumab; Alendronate; Placebo to Romosozumab; Placebo to Alendronate
Intervention type(s): Biological; Drug; Drug; Drug
Intervention description(s): Romosozumab 210 mg administered by subcutaneous injection once a month during the double-blind treatment phase.; Alendronate 70 mg tablet taken once a week; Administered by subcutaneous injection once a month during the double-blind treatment phase.; Matching placebo tablet taken once a week during the double-blind treatment phase.
Other intervention name(s): AMG 785; Evenity; Fosamax
Intervention MeSH terms: Alendronate; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteoporosis, Osteoporosis-postmenopausal, Bone Diseases-Metabolic, Bone Diseases, Musculoskeletal Diseases
Mailed FIT Outreach 2022
Condition: Colorectal Cancer; Colon Cancer
MeSH terms: Colorectal Neoplasms; Colonic Neoplasms
Study type: Interventional

Summary: 
      This project aims to evaluate different approaches to increase colorectal cancer screening
      among primary care patients at Penn Medicine through a centralized screening outreach
      program. In a pragmatic trial, we will evaluate different approaches to increase response
      rate to mailed fecal immunochemical test (FIT) kits among eligible patients, including
      differentiated packaging, sending text reminders, and personalized reminders.
    

Detailed description: 
      While colonoscopy procedures are recommended by guidelines for early detection of colorectal
      cancer, colonoscopy access remains limited due to delays in screening due to the pandemic and
      capacity issues. In this project, we will evaluate different ways of reaching out to eligible
      patients to encourage them to participate in colorectal cancer screening using fecal
      immunochemical testing (FIT). In a mailed FIT outreach campaign, we will compare user
      friendly packaging, text messaging, and personalized reminders to standard outreach with the
      goal of increasing colorectal cancer screening uptake.
    

Intervention name(s): Differentiated Box; Standard Mail; Text; No Text; Reminder; No Reminder
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Patients will receive mailed FIT kits in a box with differentiated packaging; Patients will receive mailed FIT in a standard mailing envelope; Patients will receive a series of up to 3 texts explaining the importance of colon cancer screening and prompts to complete the mailed FIT.; Patients will not receive text messaging explaining the importance of colon cancer screening or prompts to complete the mailed FIT.; Patients will receive a mailed letter reminder to complete their FIT kit if not resulted by 1 month from initial outreach.; Patients will not receive any mailed letter reminder to complete their FIT kit.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: prevention; cancer screening; mailed FIT
ATG-GCSF in New Onset Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a three-arm, 1:1:1 randomized, placebo controlled, double- blinded trial in which at
      least 28 subjects will receive active Anti-Thymocyte Globulin and Granulocyte
      colony-stimulating factor (ATG-GCSF), at least 28 subjects will receive ATG alone and at
      least 28 subjects will receive placebo alone within 100 days from diagnosis of Type 1
      Diabetes (T1D).

      The primary objective of the study will be to determine the safety and ability of low dose
      ATG plus GCSF and low dose ATG alone to retain/enhance C-peptide production in new onset T1D
      patients demonstrating residual beta cell function.
    

Detailed description: 
      The primary statistical hypothesis to be assessed in the study is whether the 2 hour area
      under the curve (change in baseline to 12 months) in residual beta cell function (C-peptide)
      will differ between those treated with ATG and GCSF or ATG alone as compared with placebo.

      The study will also examine the effect of the proposed treatments on surrogate markers for
      immunologic and metabolic outcomes.
    

Intervention name(s): Anti-Thymocyte Globulin (ATG); Granulocyte colony stimulating factor (GCSF); Placebo (for ATG); Placebo (for GCSF)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Thymoglobulin; Granulocyte colony stimulating factor (GCSF); Normal saline administered by IV infusion to mimic ATG; Placebo prepared to mimic 6mg subcutaneous injection of GCSF
Other intervention name(s): Thymoglobulin; Neulasta
Intervention MeSH terms: Lenograstim; Thymoglobulin; Antilymphocyte Serum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Type 1 Diabetes TrialNet
Effects of Music Therapy Along With Task-Oriented Training on Patients With Chronic Stroke
Condition: Hemiplegia
MeSH terms: Hemiplegia
Study type: Interventional

Summary: 
      Previous studies discussed the effects of music therapy and task oriented training on motor
      functions of stroke separately but no study is found in which effects of both techniques are
      studied. In this study, we are going to find the effects of task oriented training with or
      without music therapy.
    

Detailed description: 
      Stroke is a neurological condition, which can promote disability and increase the
      susceptibility to secondary complications along the patient's life. Stroke issue incorporates
      motor dysfunction, Cognition, daily activity and sensory weaknesses. Music Therapy appears to
      affect physiological phenomena such as blood pressure, heartbeat, respiration, and mydriasis
      as well as emotional aspects such as mood and feelings. Task-oriented training is aimed at
      improving the control strategy by solving difficulties through various measures.

      In general, a variety of techniques, including Bobath approach, Roods approach,
      Proprioceptive neuromuscular facilitation techniques, motor relearning program, functional
      approaches, stretching exercises, therapeutic massage, constrain induced movement therapy,
      range of motion exercises, myofascial release, and strengthening exercises have been in
      practice for recovery of the affected limb functional mobility in patients with stroke. This
      study will evaluate the effects of music therapy along with task oriented training on balance
      and functional independence in stroke patients.
    

Intervention name(s): Routine Physiotherapy and Task-oriented Training; Music Therapy and Task oriented Training with Routine Physiotherapy
Intervention type(s): Other; Other
Intervention description(s): The routine physiotherapy treatment will include TENS and Hot pack. The task oriented training for lower extremity will include walking training on the ground, equal weight bearing sit-to-stand exercises, resistance exercises e.g. leg press, leg extension, and leg curl and reaching tasks for improving balance. There will be a rest period of 5 minutes between each set of training.; Relaxing Music will be provided through headphones having voice cancellation property for 15 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke, Music Therapy, Task-oriented training, Balance, Functional Independence
Pain and Safety of Microneedles in Oral Cavity
Condition: Oral Cavity Disease
MeSH terms: Mouth Diseases
Study type: Interventional

Summary: 
      A randomized, crossover, double-blind, placebo-controlled, one-session clinical trial with 30
      male volunteers was performed to access pain and safety of microneedle topical application in
      different regions of the oral cavity.
    

Detailed description: 
      A randomized, crossover, double-blind, placebo-controlled, one-session clinical trial with 30
      male volunteers was performed by applying a microneedle patch in the following regions of the
      oral cavity: lip (inner lower), buccal (cheek: 1 cm behind the month angle), tongue (dorsal
      surface), hard palate (anterior region), and attached gingiva (between central and lateral
      upper incisors). A 30 gauge hypodermic needle and an identical patch but without microneedles
      sticking out, were used as positive and negative controls, respectively. The application
      force was standardized to 10N by an applicator composed of a 5 mL syringe and a spring.
      Insertions were performed with a gap of 30 seconds. Pain and discomfort associated to the
      procedure was evaluated with a Visual Analogue Scale (VAS), by a blinded-dentist. The safety
      associated to microneedle application was verified immediately after the application (0h) and
      after the next day (24h). The different application sites were inspected visually for
      bleeding, ulceration, bruising, redness or swelling.
    

Intervention name(s): Microneedle; Hypodermic needle; Flat patch
Intervention type(s): Other; Other; Other
Intervention description(s): A microneedle patch (no drug) was applied in the following oral cavity sites: lip, buccal, tongue, palatal and gingival mucosa to access pain, discomfort and safety.; 30 gauge hypodermic needle was inserted in the following oral cavity sites: lip, buccal, tongue, palatal and gingival mucosa.; A flat patch was applied in the following oral cavity sites: lip, buccal, tongue, palatal and gingival mucosa.
Other intervention name(s): positive control; negative control
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Microneedles; Buccal mucosa; Transbuccal administration
P20 Extending Sleep to Reverse Metabolic Syndrome in Middle-Aged Adults: Acceptability and Feasibility of a Sleep Intervention
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      This pilot study will test the acceptability and feasibility of a sleep extension
      intervention in community-dwelling, short-sleeping, racially/ethnically diverse middle-aged
      adults with MetS. Baseline sleep habits will be assessed and used to guide individualized
      strategies to extend sleep. A 1-group pretest-posttest study design will test the efficacy of
      this 18-week study (2 weeks of baseline data collection, 1 week of study intervention
      planning, 12 weeks of sleep intervention delivery, final follow up 3 weeks after last day of
      the 12-week intervention) on sleep duration, MetS risk behaviors (reduced physical activity,
      increased sedentary behavior, poor diet quality), symptoms associated with MetS risk
      behaviors (poor affective well-being, fatigue), and self-regulation. Socio-ecological
      barriers and facilitators to the intervention will be identified using a quantitative and
      qualitative approac
    


Intervention name(s): Sleep Intervention; Week 2 Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Sleep Diaries (Daily)
Fitbit 24/7
Phone/ video conference calls (weekly with study team)
Epworth Sleepiness Scale (weekly)
PROMIS fatigue scale-evening (weekly); Sleep Diaries (Daily)
Phone Calls (weekly with study team)
Wrist Accelerometry and fitbit 24/7 for 14 days
SAFTEE Questionnaire
ASA24
Behavioral risk factor surveillance system (smoking and alcohol use questions)
Psychological well-being (SF36)
Index of Self Regulation
PROMIS fatigue scale-morning (weekly)
PROMIS fatigue scale-evening (weekly)
Epworth Sleepiness Scale (weekly)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: sleep intervention; metabolic syndrome; hypertension; type 2 diabetes; abdominal obesity; dyslipidemia
A Phase Ib Study of Fruquintinib in 3rd Line mCRC
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Fruquintinib is a novel oral small molecule compound discovered and developed by Hutchison
      MediPharma that selectively inhibits vascular endothelial growth factor receptors (VEGFR) 1,
      2, and 3 and has demonstrated potent inhibitory effects on multiple human tumor
      xenografts.Based on first-in-human study, both 4mg QD and 5mg 3wks on/1wk off are safety and
      efficacy, this phase Ib study is to evaluable the safety, tolerability and efficacy of these
      2 regimens with mCRC failed 2nd therapy or more and to determine the recommended dose and
      regimen in phase II/III study.
    

Detailed description: 
      This is a phase Ib, randomize, interventional, open-label, multicenter study to provide
      fruquintinib to subjects diagnosed with metastatic colorectal cancer who have failed after
      standard therapy and for whom no therapy alternatives exist.

      The primary endpoint of this study will be safety.
    

Intervention name(s): fruquintinib
Intervention type(s): Drug
Intervention description(s): Fruquintinib is a capsule in the form of 1mg and 5mg, orally, daily
Other intervention name(s): HMPL-013
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: patients with mCRC who failed 2nd therapy or more