bioihbjkbjnl/mcl2 huggingface dataset:
Targeted Microbiome Transplant in Atopic Dermatitis
Condition: Atopic Dermatitis (AD)
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to examine the safety and effectiveness of a new therapy,
      commensal lotion containing infection fighting bacteria, on decreasing or eliminating the
      infection causing bacteria found on the skin of Atopic Dermatitis (AD) patients.
    

Detailed description: 
      This study will enroll adult participants, 18-60 years of age, with moderate-to-severe atopic
      dermatitis (AD) and a positive Staphylococcus aureus (S. aureus) colonized lesion (at least
      15 cm^2 in size) on the upper extremities.

      Participants who are eligible based on their positive Staph culture results will be
      randomized to one of two treatments: Targeted Microbiome Transplant Lotion (TMT) or Placebo
      (2:1 randomization). One lesional site measuring at least 15 cm^2 and one non-lesional site
      of equal size will be identified on the participant's ventral upper extremities as the target
      swabbing areas. These sites will be photographed and marked for swabbing for reference at the
      participant's future visits. Participants will be instructed to apply investigational product
      with gloved hands to their ventral upper extremities bilaterally from the wrist to the upper
      humerus, which will include the identified lesional and non-lesional swabbing sites twice a
      day for 1 week starting on Day 0. Participants will return to clinic on Day 4 for the
      assessment of adverse events, the collection of skin swabs from the identified target sites,
      and to obtain additional investigational product and gloves. Participants will complete an
      additional clinic visit on Day 7 to correspond with the end of their 1 week treatment. During
      this visit, participants will be assessed for AEs and provide skin swab samples. All unused
      product and empty packets will be returned during the Day 4 and Day 7 visits. Three
      additional clinic visits on Days 8, 9, and 11 will be scheduled for additional skin swabs to
      assess the safety and the stability of the microbiome transplant and time to recurrence of
      Staph colonization. Participants will be followed through Day 38 to assess for safety and
      disease status.
    

Intervention name(s): TMT Lotion; Placebo Lotion
Intervention type(s): Biological; Drug
Intervention description(s): TMT product and Vegetable glycerin-Cetaphil®; Cetaphil® moisturizing lotion and vegetable glycerin
Other intervention name(s): Targeted Microbiome Transplant (TMT) Lotion; Placebo for Targeted Microbiome Transplant (TMT) Lotion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: allogeneic targeted microbiome transplant (TMT); dysbiosis in AD; Staphylococcus aureus colonized skin; antimicrobial peptides (AMPs); randomized trial
Self-management Intervention for Children With Chronic Medical Complexity: Pilot Feasibility Trial
Condition: Children With Medical Complexity
Study type: Interventional

Summary: 
      The investigators have developed a tool to facilitate self-management for children with
      medical complexity (complex, multisystem chronic diseases) called MyChildCMC (My Child's
      Complex Medical Condition). MyChildCMC is an online, phone application (app) that engages
      parents daily in ongoing monitoring of common, crosscutting acute symptoms, including
      respiratory distress, inadequate feeding/fluid intake, fever, altered mental status, pain,
      and seizure status. The MyChildCMC app also guides parents to recognize early warning signs
      for health deteriorations to avoid acute events (i.e., ED visits and/or hospitalizations).

      Parent comments during the development of the MyChildCMC application revealed that the tool
      had potential in helping them manage their child's chronic conditions. This study will be the
      first to explore if online home monitoring using online technology is feasible, scalable, and
      can lead to improved CMC outcomes. This pilot feasibility trial for the MyChildCMC app will
      determine app feasibility and if successful, our approach will be a model for improving CMC
      care and reducing costs for families and children with medical complexity. Future MyChildCMC
      trials will integrate care coordination and a more robust alert system to help facilitate
      care and follow-up for patients.
    

Detailed description: 
      Aim: Investigators will assess the impact of the MyChildCMC app by comparing outcomes for the
      child and caregiver with the following outcomes:

        1. Child Quality of Life (QOL)

        2. Child Hospital and Emergency Department (ED) admissions

        3. Parent/Caregiver satisfaction with care

        4. Study participation rate

        5. Retention of intervention (intervention arm only)

        6. Adherence of intervention (intervention arm only)
    

Intervention name(s): MyChildCMC app
Intervention type(s): Other
Intervention description(s): Patients/parents will self-monitor their symptoms daily using the MyChildCMC app completing the daily vitals form. After patient/parents complete the daily form, the app provides in-app alerts and graphs showing symptom data over time.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: medical complexity; multiple chronic conditions; children
A Phase 1 Study to Evaluate Safety and Tolerability of Single and Multiple Ascending Doses of XEN-101
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this study is to assess the safety and tolerability of single and multiple
      ascending doses of XEN-101
    

Detailed description: 
      Single ascending dose (SAD) study to evaluate the safety and tolerability of XEN-101 in
      healthy participants. Multiple ascending dose (MAD) study to evaluate the safety and
      tolerability of XEN-101 in healthy participants.
    

Intervention name(s): XEN-101; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsule formulation; capsule formulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Programmed Flexor-extensor Alternating Electrical Acupiont Stimulation on Limb Functional Reconstruction After Stroke
Condition: Stroke Sequelae; Movement Disorders
MeSH terms: Stroke; Movement Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to study the effect mechanism of programmed flexor-extensor
      alternating electrical acupiont stimulation on upper limb functional reconstruction after
      stroke.
    

Detailed description: 
      After being informed about the study and potential risks, all patients who meet the inclusion
      criteria, after signing the informed consent, will be randamized divided into two groups in a
      blind manner. The patients will undergo a 3-week treatment (6 days per week and 1 day for
      rest, a total of 18 days of treatment). Those in the control group are treated with
      conventional flexor-extensor alternating electrical acupiont stimulation, and in the
      treatment group, programmed stimulation will be adopted (30 minutes, once a day). Besides,
      data from healthy participants will be collected and processed for reference and control
      purposes.
    

Intervention name(s): the fourth programmed generation of low-frequency acupoint electric stimulation therapy instrument; the fourth generation of low-frequency acupoint electric stimulation therapy instrument
Intervention type(s): Device; Device
Intervention description(s): Conventional electrical stimulation does not produce coordinated movement of multiple joints by stimulating several locally generated single ones simultaneously. The stimulation after the improved program, through different time output electrical stimulation on different parts of the muscles or muscle groups, forming the programmed motion. The purpose of this study is to achieve the rehabilitation goal of single joint - multiple joint - extensive movement, promote the coordination recovery of affected limb movement and relieve muscle fatigue.; In this study, the instrument of alternate acupoint electrical stimulation of flexor and extensor muscles combines traditional acupoint therapy with modern low-frequency electric stimulation technology, has the advantages of non-invasive and convenient application, and has a good effect on improving the range of motion of joints, relieving spasm, enhancing muscle strength, promoting the recovery of the central nervous system and other aspects.
Other intervention name(s): patent No. : ZL201610793646.9
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In addition to the control and treatment groups (30 cases in each group), healthy subjects (30 cases) also provided sEMG and EEG data for reference.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Functional electrical stimulation; Stroke Sequelae; Movement disorders
Study to Evaluate the Tolerability of Prebiotics on the Microbiota
Condition: Healthy
Study type: Interventional

Summary: 
      The primary objective of this study is to determine the tolerability of two polyglycan food
      ingredients, GOS and GLOS, at two different levels in healthy human subjects. The comparator
      in this study will be Inulin FOS, a commercially available glycan supplement.
    


Intervention name(s): GOS; GLOS; FOS
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: Microbiome; FOS; polyglycan; prebiotic; Healthy Volunteers
Complete Mesocolon Excision vs Locoregional Lymphadenectomy in Sigmoid Colon Cancer (CMELL)
Condition: Colorectal Cancer; Sigmoid Cancer
MeSH terms: Colorectal Neoplasms; Sigmoid Neoplasms
Study type: Interventional

Summary: 
      A randomized, controlled clinical trial comparing lymphadenectomy with extended inferior
      mesenteric artery ligation (complete mesocolon excision: which includes lymphoma tissue from
      the origin of the inferior mesenteric vein) with conventional locoregional lymphadenectomy in
      patients undergoing laparoscopic sigmoidectomy for sigmoid cancer.
    


Intervention name(s): Complete mesocolon excision; Conventional locoregional lymphadenectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Laparoscopic sigmoidectomy with lymphadenectomy of the lymphatic tissue that accompanies the inferior mesenteric vein and a high tie ligation of the inferior mesenteric artery (complete mesocolon excision); Laparoscopic sigmoidectomy with lymphadenectomy of the lymphatic tissue that accompanies the inferior mesenteric artery and a high tie ligation of the inferior mesenteric artery with or without section of inferior mesenteric vein.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial, single blind (the patient does not know the group to which it has been assigned) of patients undergoing laparoscopic sigmoid colon cancer resection. In all patients a lymphadenectomy with a high ligation of the Lower Mesenteric Artery will be performed. In patients in group 1A, lymphadenectomy will also include the lymphogranular tissue that accompanies the inferior mesenteric vein from its origin (complete mesocolon excision). In patients in group 1B, a conventional lymphadenectomy will be performed only from the origin of the inferior mesenteric artery without including the lymphatic tissue of the origin of the inferior mesenteric vein.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Complete mesocolon excision; Sigmoid cancer; Colorectal cancer
Low Dose Hyperbaric Bupivacaine and Dexmedetomidine as an Adjuvant, Caesarean Section
Condition: Cesarean Section; Spinal Anesthesia; Dexmedetomidine
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of this study is to evaluate the effectiveness of low dose scheme with
      dexmedetomidine as an adjuvant. Taking in consideration optimum intraoperative surgical
      conditions, best post-operative pain free experience, and more stable hemodynamic.
    


Intervention name(s): Dexmedetomidine
Intervention type(s): Drug
Intervention description(s): 10μg dexmedetomidine will be added to the injectate to be injected intrathecally
Other intervention name(s): Precedex
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cesarean Section; Intrathecal Dexmedetomidine
Strength and Awareness in Action
Condition: Stress Disorders
MeSH terms: Stress Disorders, Traumatic
Study type: Interventional

Summary: 
      The aims of this research study are to 1) assess the acceptability and feasibility of
      conducting a yoga-based intervention for Veterans receiving care at a Veterans Affairs
      Medical Center, and 2) obtain preliminary data regarding the effect of the intervention on
      Veteran's mental health.
    

Detailed description: 
      Since October of 2001, approximately over 2 million troops have been deployed in the Global
      War on Terror. Many service members are returning with both physical injuries and mental
      health conditions. High rates of both post traumatic stress disorder (PTSD) and/or mild
      traumatic brain injury (mTBI) and associated symptoms have been noted. It has been estimated
      that approximately 18-20% of returning service members meet criteria for PTSD and that 11-23%
      of veterans have a history of mTBI. It has been well established in the research literature
      that these two conditions frequently co-occur. While there is a dearth of evidence-based
      treatment for co-occurring PTSD and mTBI, it has been suggested that best practices entail
      treating presenting symptoms (hyperarousal, hypo-arousal, emotional reactivity, irritability,
      depression, anxiety, concentration problems) regardless of etiology. Yoga may be particularly
      well-suited to treating returning servicemen as data suggests that core symptoms that develop
      with a history of trauma exposure (e.g: hyperarousal; hypoarousal; emotional reactivity;
      anxiety, irritability), are physiologically based, somatically experienced and often not
      amenable to change through talking alone. In addition, yoga may assist with dysregulation
      often associated with mental health and physical conditions, and facilitate the development
      of mindfulness skills. Research suggests that that moment-to-moment awareness of present
      experience may decrease emotional reactivity and anxiety, and increase the capacity for
      self-regulation. Mindfulness skills have also been associated with: building resilience in
      the midst of stress; allowing one to better cope with physical discomfort; decreasing anxiety
      and depression; decreasing reactivity. All of these areas are relevant to improving the
      health and well-being of Veterans.
    

Intervention name(s): Yoga-based treatment
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Veterans; Yoga; Stress
Phase I Study of 5-Fluorouracil in Children and Young Adults With Recurrent Ependymoma
Condition: Central Nervous System Malignancies; Ependymoma
MeSH terms: Ependymoma
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I study to investigate the safety and pharmacokinetics of weekly
      5-fluorouracil (5-FU) administered as a bolus dose in children and young adults with
      recurrent or refractory ependymoma. The results from this study will inform a subsequent
      phase II St. Jude investigator-initiated trial.
    

Detailed description: 
      The initial 5-FU dosage will be 500 mg/m^2 administered on day 1 of course 1. We plan to
      treat a maximum of 3 cohorts of research participants (dosage levels - 0, 1, and 2) with
      escalating doses of 5-FU. A cycle is defined as 42 days. The first 6 weeks of therapy will
      constitute the dose-limiting toxicity (DLT) evaluation period.

      Primary objective

        -  To investigate the safety and pharmacokinetics (plasma and cerebrospinal fluid) of
           weekly bolus dose 5-FU in children and young adults with recurrent/refractory ependymoma

        -  To study the safety of 500 mg/m^2 weekly bolus dose 5-FU in less-heavily pre-treated
           children and young adults with recurrent/refractory ependymoma.

      Secondary objectives

        -  To document and describe toxicities associated with 5-FU administered on a weekly bolus
           schedule

        -  To document preliminary antitumor activity in participants with recurrent or refractory
           ependymoma treated with 5-FU

        -  To assess the feasibility of measuring expression level of Thymidylate Synthetase (TYMS)
           in formalin fixed paraffin embedded (FFPE) tumor samples using the Quantigene assay

        -  To evaluate the association between specific genetic polymorphisms (e.g., DPYD) and the
           pharmacokinetics of 5-FU
    

Intervention name(s): 5-fluorouracil
Intervention type(s): Drug
Intervention description(s): 5-fluorouracil, bolus dose of 500 mg/m^2 given weekly for 4 weeks followed by a two week rest period equals one cycle (6 weeks). Therapy may continue for up to 16 cycles (about 2 years).
Other intervention name(s): 5-FU
Intervention MeSH terms: Fluorouracil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Link Between Obesity And Vitamin D in Bariatric Patients With Omega-loop Bypass Surgery
Condition: Bariatric Surgery Candidate
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study is to increase vitamin D concentrations or to keep it on high level,
      respectively, by supplementing with vitamin D3 in a different dose regime, and to improve the
      overall health status in bariatric patients. In this project, the vitamin D status, the
      parameters of inflammation, bone turnover, insulin resistance, liver and depression score of
      bariatric patients are expected to improve, due to supplementation of a loading dose compared
      to the standard therapy.
    


Intervention name(s): Cholecalciferol; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Cholecalciferol; Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bariatric surgery; vitamin D; supplementation
Nasal Budesonide Efficacy on Nasal FeNO in Children With Allergic Rhinitis
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 4

Summary: 
      In clinical trials for treatment of allergic rhinitis a significant reduction of the total
      symptom score compared to baseline has been demonstrated by using nasal budesonide.Previous
      results in adults show that the assessment and monitoring del nasal fractional exhaled nitric
      oxide (nFeNO) is useful in controlling inflammation of nasal allergic rhinitis.

      Primary objective of this study is to evaluate efficacy of nasal budesonide (aqueous
      solution) on the nasal inflammation marker (nFeNO).

      Secondary outcomes are the evaluation of: changes in total nasal symptom score (Total Symptom
      Score, T5SS), changes in cell counts in nasal lavage (LN) and the changes reported sleep
      quality (Pittsburgh Sleep Quality Index, PSQI).
    


Intervention name(s): Budesonide nasal spray (100 mcg bid); Budesonide nasal spray (50 mcg bid
Intervention type(s): Drug; Drug
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Adipose-derived SVF for the Treatment of Knee OA
Condition: Osteoarthritis (OA)
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      This is a pivotal study. The study will examine the safety and efficacy of autologous
      adipose-derived stromal vascular fraction (SVF) cells processed with the GID SVF-2 device for
      pain, function and stiffness in the knees of osteoarthritic subjects.
    

Detailed description: 
      Osteoarthritis is the main form of arthritis and affects over 20 million people in the United
      States. In the knee it can cause severe pain, reduced functionality and increased stiffness
      thus, a treatment that would reduce pain, increase function and reduce stiffness would be of
      benefit to many people.

      This study will collect and disassociate adipose tissue and inject the stromal vascular
      fraction into the knee of the same patient. The study is controlled, randomized and
      double-blinded with 2 SVF treatments (high and low dose) and a placebo control.
    

Intervention name(s): GID SVF-2; Placebo
Intervention type(s): Device; Other
Intervention description(s): The GID SVF-2 device is a sterile single-use disposable canister used for harvesting, filtering, separating, and concentrating autologous stromal vascular fraction cells from adipose tissue for reintroduction to the same patient during a single surgical procedure for treatment of pain associated with joint osteoarthritis.; Placebo Control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment