bioihbjkbjnl/mcl2 huggingface dataset:
Immuno-regulatory Profiling of T Cells in GVHD Treated With Extracorporeal Photopheresis
Condition: GVHD
Study type: Observational

Summary: 
      Extracorporeal Photopheresis (ECP) has been used as one of the treatments for graft versus
      host disease (GVHD). Responses were observed in skin, liver, GI tract, mouth, eye and lung.
      ECP does not cause immune suppression and therefore less risk of infection or relapse of
      malignancy. However, the exact mechanism of action of this expensive procedure is not fully
      understood and no predictors of response to ECP are known so far. This reflects the need for
      a better understanding of GVHD and its response to ECP. Blood samples from 15 patients who
      receive ECP as part of the treatment of GVHD at our institution will be collected. Samples
      will be analyzed using flow cytometer
    


Intervention name(s): blood samples
Intervention type(s): Other
Intervention description(s): Blood samples from 15 patients who receive ECP as part of the treatment of GVHD at our institution will be collected. Samples will be analyzed using the flow cytometer
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients who are recipients of allogeneic stem cell grafts with the diagnosis of GVHD
        according to established criteria and physician decides to treat using ECP
      
Biospecimen description: 
      Blood samples from 15 patients who receive ECP as part of the treatment of GVHD at our
      institution will be collected. Samples will be analyzed using the flow cytometer
Electrical Impedance Myography as an Outcome Measure in Amyotrophic Lateral Sclerosis Clinical Trials
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Observational

Summary: 
      Trials evaluating new therapies for stopping or slowing the progression of ALS depend
      critically upon the use of outcome measures to assess whether a potential treatment is
      effective. The more effective an outcome measure, the fewer patients need to be enrolled and
      the shorter the trial. Many outcome measures have been used over the years, including
      strength assessments, breathing tests, functional status surveys, and nerve testing, but all
      are far from ideal. A new method, called electrical impedance myography (EIM) appears to be
      especially promising in that it provides very consistent data from one testing session to the
      next, is sensitive to the muscle deterioration that occurs in ALS, and is entirely painless
      and non-invasive. In this study, investigators from multiple institutions plan to compare
      several different outcome measures, including EIM, in approximately 120 ALS patients, with
      each patient being followed for a period of one year. All of these measures will be compared
      to one another and an assessment of their ability to detect disease progression made. Our
      goal will be to determine whether EIM can serve as a valuable new outcome measure, ultimately
      leading to substantially faster, more effective ALS trials requiring fewer patients.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with amyotrophic lateral sclerosis (ALS)
      
Keywords: amyotrophic lateral sclerosis; motor neuron disease; outcome measure; biomarker; impedance
Radiation Therapy Plus Carboplatin and Lobradimil in Treating Children With Newly Diagnosed Brain Stem Gliomas
Condition: Brain and Central Nervous System Tumors
MeSH terms: Glioma; Nervous System Neoplasms; Central Nervous System Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as
      carboplatin and lobradimil may make the tumor cells more sensitive to radiation therapy.

      PURPOSE: Phase I trial to study the effectiveness of combining radiation therapy with
      carboplatin and lobradimil in treating children who have newly diagnosed brain stem gliomas.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the maximum tolerated duration of lobradimil plus carboplatin with
           radiotherapy in patients with newly diagnosed brain stem gliomas.

        -  Determine the toxic effects of this treatment regimen in these patients.

        -  Assess the response to radiotherapy in patients treated with this regimen.

      OUTLINE: Patients receive radiotherapy for 5 consecutive days a week for 6.5 weeks, for a
      total of 33 doses. Patients receive carboplatin IV over 15 minutes followed by lobradimil IV
      over 10 minutes concurrently with radiotherapy.

      The first cohort of 3-6 patients receives treatment with carboplatin and lobradimil for the
      first three weeks of radiotherapy, with the duration of chemotherapy increasing by one week
      with each subsequent cohort until the maximum duration of 6.5 weeks is reached or until
      unacceptable toxicity occurs in 2 of 6 patients.

      Patients are followed at 6 weeks; every 3 months for 2 years; every 6 months for 3 years; and
      then annually thereafter.

      PROJECTED ACCRUAL: A total of 15-24 patients will be accrued for this study within 36 months.
    

Intervention name(s): carboplatin; cereport; radiation therapy
Intervention type(s): Drug; Drug; Radiation
Other intervention name(s): Paraplatin; CBDCA; NSC #241240; labradimil; IND #60315
Intervention MeSH terms: Carboplatin
Primary purpose: Treatment
Keywords: untreated childhood brain stem glioma
CPAP in SAHS Patients With Hypertension
Condition: Sleep Apnea Syndromes; Hypertension
MeSH terms: Apnea; Sleep Apnea Syndromes; Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      Study objective: To assess the nocturnal changes in mechanosensitivity and chemosensitivity
      in hypertensive sleep apnea-hypopnea syndrome (SAHS) patients and in SAHS patients with
      isolated nocturnal hypertension. To value the continuous positive airway pressure (CPAP)
      effect on these parameters.

      Design: Controlled cross-over longitudinal study. Settings: Madrid metropolitan area.
      Patients: Day-night sustained hypertensive and isolated nocturnal hypertensive patients with
      SAHS without previous treatment. At least 30 patients are needed.

      Interventions: Patients will allocate in each treatment arm (CPAP vs. sham CPAP) during three
      months. Explorations will perform before and immediately after sleep at 0-, 3-, and 6-months
      of trial.

      Measurements: 24-h urinary catecholamine, local vascular factors, angiotensin and aldosterone
      levels. Diaphragmatic tension-time index, metabolic rate, hypoxic withdrawal test, and
      ventilatory and inspiratory neural drive responses to progressive isocapnic hypoxia.
    


Intervention name(s): CPAP nasal; sham CPAP nasal
Intervention type(s): Device; Device
Intervention description(s): During the night; During the night
Other intervention name(s): Nocturnal support with continuous positive airway pressure; sham CPAP
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: sleep apnea; hypertension; mechanosensitivity; chemosensitivity; adhesion factors
Effectiveness of Adalimumab in Moderate to Severe HidrAdenitis SuppuRativa Patients - a Multi cOuNtry studY in Real Life Setting
Condition: Hidradenitis Suppurativa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Study type: Observational

Summary: 
      This study will assess the effects of adalimumab treatment in moderate to severe Hidradenitis
      Suppurativa (HS) patients in the real world setting. The objectives of this study are to
      estimate the effectiveness of adalimumab treatment on disease severity, to estimate the
      impact of adalimumab treatment on patients' quality of life, psychological effect, work
      productivity and healthcare resource utilization and to describe treatment practices over the
      study period.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Hidradenitis Suppurativa (HS) participants receiving adalimumab
      
Keywords: Moderate to Severe Hidradenitis Suppurativa; Adalimumab
Safety and Immune Response to FMPV-1
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single centre, open-label, non-randomized, Phase I study assessing safety and
      immune response of FMPV-1 in healthy male subjects.
    

Detailed description: 
      To date, there is no clinical experience with FMPV-1. This is the first clinical study with
      FMPV-1 in healthy volunteers to assess the safety and immunogenicity of FMPV-1 in man. The
      study population will include 16 healthy males in 2 cohorts (8 per cohort) to ensure data in
      a minimum of 14 subjects.

      Up to two dose levels of FMPV-1 in conjunction with the adjuvant granulocyte macrophage
      colony stimulating factor (GM-CSF) will be assessed - the dose in Cohort 2 will depend on the
      safety and specific delayed type hypersensitivity (DTH) response data from Cohort 1. Each
      cohort will follow the same study design. Following preliminary screening procedures,
      subjects will be admitted in the morning on the day before initial dosing (Day -1). In
      Cohorts 1 and 2, subjects will receive FMPV-1 15 ± 5 min after GM-CSF on Days 1, 8, 15, 29
      and 43 as an intradermal injection into the back of the upper arm. In Cohort 1, 8 subjects
      will receive GM-CSF (0.03 mg) + FMPV-1 (0.15 mg/injection: low dose) administered as 2
      separate intradermal injections. In Cohort 2, 8 subjects will receive GM-CSF (0.03 mg) +
      FMPV-1 (either 0.15 or 0.3 mg/injection - dependent on Cohort 1 data) administered as 2
      separate intradermal injections.

      Sentinel dosing will be applied for both cohorts if different doses are used; if the same
      dose is to be used in both cohorts, sentinel dosing will not be applied in Cohort 2.

      Adverse events and laboratory assessments will be the endpoints to assess the safety of
      GM-CSF/FMPV-1 vaccination. FMPV-1 specific DTH responses and FMPV-1-specific proliferative
      T-cell responses will be the endpoints to assess the FMPV-1 specific immune response.
      Subjects will receive a total of 8 administrations intradermally: GM-CSF + FMPV-1 on 5
      separate occasions and FMPV-1 (without GM-CSF) on 3 occasions for the DTH skin reactivity
      assessment. The main part of the study will last for approximately 16 weeks, including
      screening, and subjects will return for follow-up visits after 6 months and 12 months. The
      overall estimated time from screening until the final follow-up visit is approximately 12
      months. All adverse reactions will be collected until early withdrawal or discharge from the
      study after the 12-month follow-up visit.
    

Intervention name(s): FMPV-1; GM-CSF (as adjuvant)
Intervention type(s): Biological; Biological
Intervention description(s): Intradermal administration; Intradermal administration
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: FMPV-1; Cancer-specific vaccine; Neoantigen; GM-CSF adjuvant
Investigation of the Efficacy of Treatments With Backup Device in Spine Pathologies
Condition: Spine Disease; Neck Pain; Back Pain; Disc Herniation
MeSH terms: Intervertebral Disc Displacement; Spinal Diseases; Neck Pain
Study type: Interventional

Summary: 
      Our aim in this study is to examine the effectiveness of the Backup spine health device in
      spinal problems and compare it with traditional physical therapy methods.
    

Detailed description: 
      The investigators study was planned as a randomized controlled study. Participants will be
      divided into 2 groups as conventional physiotherapy and Backup group by simple randomized
      method. Participants will be taken to a treatment program for 10 weeks, 3 days a week.
      Parameters such as pain, posture, sleep quality, quality of life, muscle shortening at the
      beginning and end of the study. The results will be analyzed statistically.
    

Intervention name(s): conventional physiotherapy; Backup therapy
Intervention type(s): Other; Other
Intervention description(s): hotpack electrotherapy ultrasound exercises; The backup spine health device is in the form of a mat and provides segmental electrical stimulation to the spines. At the same time, the mat can heat up to 40 degrees during the treatment process. Backup spine health device is very effective in both reducing pain and strengthening the muscles with electrical stimulations by reaching even the deep muscles around the spine. Sessions consist of 30 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: conventional physiotherapy and backup device therapy
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Backup; physiotherapy
Edible Plant Exosome Ability to Prevent Oral Mucositis Associated With Chemoradiation Treatment of Head and Neck Cancer
Condition: Head and Neck Cancer; Oral Mucositis
MeSH terms: Head and Neck Neoplasms; Mucositis; Stomatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the ability of grape exosomes, given to the subject as grape powder,
      as an important anti-inflammatory agent to reduce the incidence of oral mucositis during
      radiation and chemotherapy treatment for head and neck tumors.
    

Detailed description: 
      The purpose of this study is to investigate the ability of plant (grape) exosomes to prevent
      oral mucositis associated with chemoradiation treatment of head and neck cancer. Also, to be
      evaluated is the effect of grape exosomes on the production of cytokines and immune responses
      to tumor exosomal antigens, metabolic and molecular markers in these patients.
    

Intervention name(s): Grape extract; Lortab, Fentanyl patch, mouthwash
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): Grape extract self-administered by mouth daily for 35 days; Lortab 5-10 mg Fentanyl patch 25 mcgs Mary's Magic Mouthwash
Other intervention name(s): Lortab 5-10 mg; Fentanyl patch 25 mcgs; Mary's Magic Mouthwash
Intervention MeSH terms: Acetaminophen, hydrocodone drug combination; Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Plant exosomes; Grape exosomes; Grape extract; Oral mucositis; Head and Neck Cancer; Immune response
Ascending Multiple Intravenous Doses of AON-D21 in Healthy Male Subjects.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate safety, tolerability, pharmacokinetics and
      pharmacodynamic parameters after multiple ascending intravenous doses of AON-D21 in healthy
      male subjects.
    

Detailed description: 
      This study will potentially include 2 two sequential cohorts with 8 healthy male subjects per
      cohort, then 16 enrolled subjects in total. Within each dose group 6 subjects will be
      randomized to receive AON-D21 and 2 subjects will be randomly assigned to placebo.
    

Intervention name(s): AON-D21; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): AON-D21 is a PEGylated L-configured aptamer that binds and thereby neutralizes the complement component C5a from activating both C5a receptors.; Isotonic glucose solution identical in appearance to AON-D21.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Sequential: Two groups of participants will be assigned to receive AON-D21 or placebo in ascending dose order. Dose will be escalated based on safety and pharmacokinetic data.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Writing About Disease: Effect on Rehabilitation?
Condition: COPD; Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Therapeutic writing about one's emotions has been described previously (J Pennebaker:
      Emotions, disclosure and health. Am Psychol. Assoc 1995). The present project will compare
      the effects (if any) of writing about the emotional versus the physical consequences of lung
      disease on anxiety, perceived quality of life, and perceived health status.
    

Detailed description: 
      Chronic obstructive pulmonary disease (COPD) patients (age 35-70) and asthma patients (age
      20-60) referred to a 4 weeks inpatient rehabilitation program - who agree to participate in
      the project - are randomly assigned to one of three conditions:

        -  Writing about emotional consequences of their disease before the program starts

        -  Writing about physical consequences of their disease before the program starts

        -  Not writing

      All patients are measured (completing questionnaires at home) on: perceived quality of life,
      perceived health status and trait anxiety - 2 weeks before the program, 2 weeks after the
      program and 6 months after the program. FEV1 and 6 min walking distance are measured at the
      beginning and by the end of the program.

      In addition to questionnaires, all patients are asked to:

        -  Write in their own words ( 2 weeks after) to evaluate their stay at the rehabilitation
           clinic; and

        -  Write in their own words (6 months after) about how the disease affects their life at
           that point.

      Both quantitative and qualitative data will be used for analysis purposes.
    

Intervention name(s): writing about disease
Intervention type(s): Procedure
Intervention description(s): writing about physical or emotional consequences of pulmonary disease
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: copd; asthma; QoL; Perceived health status; Trait anxiety
Portable Oxygen Concentrator to Improve Quality of Life in Chronic Obstructive Pulmonary Disease
Condition: COPD
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      -  Evaluate subjects in an prospective observational study

        -  Subjects will be administered scientifically validated questionnaires

        -  Determine the affect of the Portable Oxygen Concentrator (POC) on improvements in:

             1. Exercise capability, dyspnea and quality of life as primary endpoints

             2. Utilize:

                  1. Baseline Dyspnea Index (BDI)

                  2. Transitional Dyspnea Index (TDI)

                  3. Chronic Respiratory Disease Questionnaire (CRQ)

                  4. Six minute walk test (6MWT)

                  5. Epworth Sleepiness Scale (ESS)

        -  The secondary endpoints will be:

             1. Rate of exacerbations, sleep quality

             2. Health care utilization (emergency room encounters, hospital admissions)
    

Detailed description: 
      Evaluate subjects in an prospective observational study in which subjects will be screened
      and administered scientifically validated questionnaires at study entry and during the
      observation period at specified intervals to determine the affect of the Portable Oxygen
      Concentrator on improvements in exercise capability, dyspnea and quality of life as primary
      endpoints, utilizing the Baseline Dyspnea Index (BDI), Transitional Dyspnea Index (TDI), the
      Chronic Respiratory Disease Questionnaire (CRQ) and six minute walk test (6MWT). The
      secondary endpoints will be rate of exacerbations, sleep quality (reported as number of hours
      sleep improvement; utilize Epworth Sleepiness Scale [ESS]), and health care utilization
      (emergency room encounters, hospital admissions).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        COPD Patients prescreened and selected by their primary care physician or pulmonologist
      
Keywords: COPD; LTOT; Long-Term Oxygen Therapy; Portable Oxygen Concentrator; Quality of Life; Six Minute Walk Distance Test
Effectiveness of Donor Human Milk Supplementation for the Treatment of Hypoglycemia in the Breastfed Infant
Condition: Neonatal Hypoglycemia
MeSH terms: Hypoglycemia
Study type: Interventional

Summary: 
      The purpose of this study is to compare if newborn infant hypoglycemia can be improved with
      bottle supplementation of commercially-sterilized donor human milk compared to standard
      infant formula. Hypothesis is that supplementation with commercially-sterilized donor human
      milk will improve hypoglycemia and limit formula use in exclusively breastfed infants.
    

Detailed description: 
      Enrolled infant participants will receive a maximum of two bottle feeding supplementations
      (of their designated treatment arm for either 20 calorie-per-ounce commercially-sterilized
      donor human milk OR 20-calorie-per-ounce standard infant formula) as treatment if they meet
      hypoglycemia criteria. Infant participants will complete the study if 1) they have received
      two bottle feeding supplementations for treatment of hypoglycemia, 2) they only received one
      bottle supplementation and hypoglycemia resolved, 3) if the medical teams deems the infants
      requires a higher level of care for their hypoglycemia (example: admission to the newborn
      intensive care unit for intravenous fluids with dextrose).
    

Intervention name(s): Bottle Supplementation--Commercially-Sterilized Donor Human Milk; Bottle Supplementation--Standard Infant Formula
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Supplementation by bottle with 20-calorie-per-ounce commercially-sterilized donor human milk (up to 15 ml, up to two times) for infants meeting hypoglycemia criteria and randomized to this treatment arm.; Supplementation by bottle with 20-calorie-per-ounce standard infant formula (up to 15 ml, up to two times) for infants meeting hypoglycemia criteria and randomized to this treatment arm.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: neonatal; newborn; hypoglycemia; human milk; breastfed; donor milk
Study to Evaluate the Pharmacokinetics of Single and Multiple Doses of Apremilast in Healthy Adult Male Korean Subjects
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This two-part study was designed to evaluate the pharmacokinetics (PK) of single and multiple
      doses of apremilast in healthy adult Korean males.
    

Detailed description: 
      The study will consist of two parts. Part 1 will evaluate the PK of ascending single doses of
      apremilast. Part 2 will evaluate the PK of apremilast when administered as multiple doses
      over 14 days.
    

Intervention name(s): Apremilast; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablet for oral administration; Tablet for oral administration
Other intervention name(s): CC-10004; OTEZLA®
Intervention MeSH terms: Apremilast
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Part 1 of the study was a 3-treatment period, 3-sequence crossover study. Part 2 was a parallel-group, placebo-controlled, single-period study.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics; Apremilast; Healthy Adult Male; Korean Subjects