bioihbjkbjnl/mcl2 huggingface dataset:
Early Molecular Changes in Vitiligo After Narrowband Ultraviolet Therapy
Condition: Vitiligo; Dermatology/Skin - Other
MeSH terms: Vitiligo
Study type: Interventional

Summary: 
      Vitiligo is a chronic acquired cutaneous disease of pigmentation that affects patients'
      quality of life across all degrees of involvement and severity. Phototherapy, such as Narrow
      band UVB (NB-UVB), is a clinically indicated treatment for skin lesions. NB-UVB treatment has
      been shown to promote repigmentation and normalize cellular behaviors. The investigators
      would like to analyze the change in protein expression and histological change in skin from
      NB-UVB treatment in participants with Vitiligo.

      The investigators are recruiting participants with Vitiligo on the body, arms, and/or legs.
    

Detailed description: 
      This is a dermatology study of the effects of short-term NB-UVB treatment, standard
      phototherapy for Vitiligo patients. In the study, demographics information, three ascending
      dose of phototherapy, and small skin biopsies will be required of the participants.

      For all enrolled participants, the starting dose of NB-UVB administered will be 250 mJ/cm2,
      which is the standard of care for patients with Vitiligo. The dose will be increased by 10%
      with each treatment, as long as there are no side effects with treatment such as burning or
      redness/ erythema. Small skin biopsies will be collected from normal skin and from affected
      skin from vitiligo participants at the baseline visit and 3 days after the conclusion of
      treatment; up to a total of 6 biopsies will be collected from each patient. Participants will
      be compensated for time and effort.
    

Intervention name(s): Phototherapy (NB-UVB) via the 3 Series PC & SP phototherapy cabinet
Intervention type(s): Device
Intervention description(s): This is an investigator-initiated, single-blinded, ascending dose study of NB-UVB treatment for Vitiligo in adults of 3 treatments for one week. It is designed to measure the molecular changes and re-pigmentation in affected and normal skin of participants with Vitiligo and normal skin in healthy participants.
Intervention model: Single Group Assignment
Intervention model description: Participants diagnosed with Vitiligo who are enrolled in the study will receive phototherapy (NB-UVB), with the starting dose of 250 mJ/cm2. The dose will be increased by 10% with each treatment. Small skin samples will be collected before and after NB-UVB treatment.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vitiligo; Dermatology; Johns Hopkins; Compensation; Paid; Phototherapy; NB-UVB; Light treatment; Skin; Biopsies; Money; Short-term
A Study to Evaluate the Safety and Efficacy of CCX354-C in Subjects With Rheumatoid Arthritis Partially Responsive to Methotrexate Therapy
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, placebo-controlled, Phase 2 study to evaluate the safety
      and efficacy of CCX354-C in subjects with rheumatoid arthritis partially responsive to
      methotrexate therapy.
    


Intervention name(s): CCX-354-C; Placebo; CCX354-C
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 200mg film-coated tablets once daily for 12 weeks + Methotrexate; Placebo film-coated tablets twice daily for 12 weeks + methotrexate; 100mg film-coated tablets twice daily for 12 weeks + methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pivotal Efficacy and Safety Registration Trial of FP187 in Moderate to Severe Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial is to investigate the efficacy and safety of different doses and
      dose administrations of FP187 compared to a placebo treatment in patients with moderate to
      severe plaque psoriasis.
    

Detailed description: 
      The trial tests two different dose levels and two different daily dosing schedules (twice
      daily (BID) and three times daily (TID))over 20 weeks of treatment. Key is effect as measured
      by achievement of a 75% reduction in PASI after 20 weeks and safety monitored by adverse
      events and safety lab.

      There are 3 active arms:

        1. FP-187 at a daily dose of 750mg divided in three doses (250mg TID)

        2. FP-187 at a daily dose of 750mg divided in two doses (375mg BID)

        3. FP-187 at a daily dose of 500mg divided in two doses (250mg BID)

      and 1 placebo arm.

      An additional open (flexible dosing) treatment arm has been amended to the trial
    

Intervention name(s): Placebo; FP187; FP187; FP187; FP187
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Placebo tablets; High daily dose of 750mg administered as 250mg TID; High daily dose of 750mg administered as 375mg BID; Low daily dose of 500mg FP187 administered as 250mg BID; Oral tablets, up to 3 times daily for 20 weeks.
Other intervention name(s): Placebo of FP187
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Safety and Effectiveness of 524W91
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the safety and pharmacokinetics of single oral doses of 524W91 administered in
      HIV-infected patients. To determine the effects of food on bioavailability of 524W91.
    

Detailed description: 
      Patients are randomized to receive six single escalating doses of 524W91 or placebo, with
      each dose separated by at least a 6-day washout interval. In the time between 2 of the doses,
      the effect of food on pharmacokinetics will be investigated, with one dose administered in
      conjunction with a high-fat meal and one dose administered in a fasted state.
    

Intervention name(s): Emtricitabine
Intervention type(s): Drug
Intervention MeSH terms: Emtricitabine
Primary purpose: Treatment
Keywords: Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Antiviral Agents
Anti-thymocyte Globulin-induced Immune Senescence
Condition: Disorder Related to Renal Transplantation
Study type: Observational

Summary: 
      The aim of the study is to investigate the impact of Anti-Thymocyte Globulin (ATG) on immune
      senescence. Markers of immune senescence expression is assessed in a prospective cohort of
      renal transplant recipients the day of transplantation and one year after renal
      transplantation.
    

Detailed description: 
      The anti-thymocyte globulin (ATG) are used in the prevention and treatment of acute rejection
      in organ transplantation. They are at the origin of a brutal CD4 lymphocyte depletion
      followed by a gradual recovery of the lymphocyte pool. Nevertheless, CD4 lymphopenia can
      persist in some patients.

      SIGAL study aims to characterize the immune responses of lymphopenic patients (after
      administration of ATG) in order to identify possible similarities with immunosenescence.The
      immunosenescence is a complex and profound remodeling of the immune system during life. It is
      mainly due to thymic involution and repeated antigenic stimulation.
    

Intervention name(s): Blood sample
Intervention type(s): Other
Intervention description(s): A blood sample is performed one year after kidney transplantation.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients awaiting kidney transplantation, followed at Besançon University Hospital and who
        have given their consent for the conservation of cells for a study of the immune system in
        kidney transplant patients.
      
Biospecimen description: 
      Peripheral Blood Mononuclear Cells
    
Keywords: Kidney transplantation; Immunosuppressive treatment
Brief Hospitalization for Schizophrenia: Strategies to Improve Treatment Outcome
Condition: Schizophrenia; Schizophrenic Disorder
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      The goal of this research program is to implement a series of psychoeducational training
      classes designed to teach individuals with schizophrenia the importance of medication
      treatment, how to identify and manage medication side effects, and how to make appointments
      and emergency plans. The skills taught to the research subjects will lead to demonstrable
      increases (compared to the control group) in adherence to both the prescribed medication
      regimen and scheduled outpatient appointments and thereby cause a decrease (again compared to
      the control group) in rehospitalization rates and bed-days during subsequent twelve months
      following the intervention. A secondary objective of this work is that if the CREP program is
      successful and/or illness education is effective, the data will be able to disseminated
      throughout the VISN 22 via the recently awarded Mental Illness Research Education and
      Clinical Center (MIRECC) program.
    


Intervention name(s): Community Re-Entry Program: What is Schizophrenia
Intervention type(s): Behavioral
Intervention model: Parallel Assignment
Irinotecan Plus Cisplatin vs Pemetrexed Plus Cisplatin as 2nd Line in NSCLC Stage IIIB/IV
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial will compare the efficacy of irinotecan/cisplatin and pemetrexed/cisplatin in the
      second-line treatment of patients with stage IIIB/IV NSCLC
    

Detailed description: 
      Non-platinum-based doublets including the newer drugs can be used instead of platinum-based
      regimens in the first line treatment of patients with advanced NSCLC. Docetaxel or pemetrexed
      have been proven effective as second-line treatment of patients with NSCLC. In a study
      conducted by our group the combination of irinotecan/cisplatin demonstrated higher response
      rates over cisplatin monotherapy in patients progressing after first-line
      docetaxel/gemcitabine. Moreover, pemetrexed has been combined with the platinums (ie,
      cisplatin, carboplatin, and oxaliplatin) in NSCLC to yield clinical activity similar to that
      of other platinum-based doublets. The efficacy of different platinum-based combinations in
      patients pretreated with non-platinum based first-line chemotherapy is not known.
    

Intervention name(s): Irinotecan; Cisplatin; Pemetrexed
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Irinotecan at the dose of 110 mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles; Cisplatin at the dose of 80 mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles; Pemetrexed at the dose of 500mg/m2 IV every 3 weeks for 6 consecutive cycles
Other intervention name(s): CPT-11; CDDP; Alimta
Intervention MeSH terms: Irinotecan; Pemetrexed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cancer; NSCLC; second-line chemotherapy; irinotecan; pemetrexed
Study on the Effects of Sacubitril/Valsartan on Physical Activity and Sleep in Heart Failure With Reduced Ejection Fraction Patients.
Condition: Heart Failure, Reduced Ejection Fraction
MeSH terms: Heart Failure; Heart Failure, Systolic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to investigate the effects of initiation of
      sacubitril/valsartan vs enalapril treatment on objective measures of both waking activity and
      sleep in subjects with heart failure with reduced ejection fraction.
    


Intervention name(s): sacubitril/valsartan (LCZ696); enalapril; matching placebo sacubitril/valsartan (LCZ696); matching placebo enalapril
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): sacubitril/valsartan tablet taken orally.; Enalapril tablet taken orally.; matching placebo sacubitril/valsartan tablet taken orally; matching placebo enalapril tablet taken orally
Intervention MeSH terms: Valsartan; Enalapril; Enalaprilat; Sacubitril and valsartan sodium hydrate drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Heart failure with reduced left ventricular ejection fraction (LVEF); Cardiac dysfunction; Heart muscle dysfunction; Left ventricular (LV) dilation; Left ventricular hypertrophy; HF; AHF; CHF; acute heart failure; chronic heart failure; congestive heart failure; congestive cardiac failure; Heart failure; HReEF; Physical Activity; Actigraphy; Home sleep test; wake
Choose Health: Food, Fun, and Fitness Curriculum Promotes Positive Behaviors in 3rd-5th Graders Compared to Control
Condition: Childhood Obesity; Nutrition Poor
MeSH terms: Pediatric Obesity; Malnutrition
Study type: Interventional

Summary: 
      The Choose Health: Food, Fun, and Fitness (CHFFF) curriculum was evaluated in 3rd-5th
      graders, hypothesizing that change pre- to post- CHFFF education would be greater than in the
      same child during a delayed intervention control period.
    

Detailed description: 
      Choose Health: Food, Fun, and Fitness (CHFFF) is a Cornell curriculum for 3rd-6th graders
      targeting behaviors to prevent obesity and chronic disease risk: fewer sweetened drinks; more
      vegetables, fruits, and whole grains; fewer high-fat and high-sugar foods; and active play.
      The 6 lessons use experiential learning, food preparation, active games, goal setting, and a
      family newsletter. It was evaluated in 561 Expanded Food and Nutrition Education (EFNEP)
      participants in 27 after-school and 28 in-school groups in 5 NY counties in 2015 using a
      quasi-experimental design, with a delayed-intervention control period prior to CHFFF. Youth
      completed a self-reported survey 3 times: at initial enrollment, after a 6-week
      no-intervention control period, and after receiving the 6 weekly CHFFF lessons. Outcome
      measures included dietary intake scores created based on factor analysis, and related
      precursors. It was hypothesized that change pre- to post- CHFFF education would be greater
      than in the same child during the delayed intervention control period. Following CHFFF, youth
      improved significantly (p<.05) compared to their control period in overall diet quality,
      vegetable intake, fruit intake, soda/fast food intake and choice, and the frequency with
      which they read nutrition facts labels, shared about healthy eating with their family, and
      tried a new food.
    

Intervention name(s): CHFFF nutrition education
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Intervention model description: Delayed intervention
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Nutrition education; Evaluation; Child diet; EFNEP
A Study to Assess Pharmacokinetics (PK) of Brensocatib Alone and With Multiple Doses of Rifampin or Esomeprozole in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to assess the effects of rifampin on the PK of
      brensocatib in Part 1 of the study and to assess the effects of esomeprazole on the PK of
      brensocatib in Part 2 of the study.
    


Intervention name(s): Brensocatib; Rifampin; Esomeprazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral tablets.; Oral capsules.; Oral capsules.
Other intervention name(s): INS1007
Intervention MeSH terms: Rifampin; Esomeprazole
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Brensocatib; INS1007
Effects of Physical Training on Heart Rate Variability and Exercise Capacity in Diabetes With Autonomic Neuropathy
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      This study aimed to investigate effects of physical training on exercise capacity and changes
      of heart rate variability (HRV) at rest, during exercise, and post-exercise in the patient
      with diabetes with autonomic neuropathy (DAN).
    


Intervention name(s): exercise training
Intervention type(s): Other
Intervention description(s): The exercise group took supervised aerobic training twice per week at hospital and thrice per week at home for eight weeks at the intensity of 60-70% VO2peak
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: diabetes mellitus; autonomic neuropathy; exercise training; exercise capacity; heart rate variability
To Demonstrate the Relative Bioavailability of Alprazolam Tablets, 2 mg
Condition: Anxiety
Study type: Interventional
Phase: Phase 1

Summary: 
      To Demonstrate the Relative Bioavailability of Alprazolam Tablets, 2 mg.
    


Intervention name(s): Alprazolam Tablets, 2 mg (Geneva Pharmaceuticals, Inc.)
Intervention type(s): Drug
Intervention MeSH terms: Alprazolam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetic Study in Healthy Males
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the pharmacokinetics of levodopa, carbidopa,
      3-OMD and ODM-104 after repeated doses of 3 levodopa formulations given in combination with
      carbidopa and ODM-104.
    


Intervention name(s): levodopa, carbidopa, ODM-104
Intervention type(s): Drug
Other intervention name(s): Sinemet
Intervention MeSH terms: Levodopa; Carbidopa
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
beCLomethasone Efficacy in Acute Rhinosinusitis - CLEAR Study
Condition: Acute Rhinosinusitis
MeSH terms: Sinusitis
Study type: Interventional
Phase: Phase 3

Summary: 
      Intranasal corticosteroids are beneficial in the treatment of acute rhinosinusitis. As
      adjunctive therapy to oral antibiotic treatment, mometasone furoate at doses of 200 μg or 400
      μg twice daily, was well tolerated and significantly more effective in reducing the symptoms
      of rhinosinusitis than antibiotic therapy alone. Furthermore,the addition of fluticasone
      propionate to xylometazoline and antimicrobial therapy with cefuroxime improved clinical
      success rates and accelerated recovery of patients with a history of chronic rhinitis or
      recurrent sinusitis who present for treatment of acute rhinosinusitis.

      The present study was planned to assess the effects of nebulised beclomethasone dipropionate
      given as add-on therapy to standard care (oral antibiotics) in the treatment of acute
      symptomatic rhinosinusitis. Antibiotic therapy will be at the physicians' discretion.
    


Intervention name(s): beclomethasone dipropionate 800 mcg/2 ml suspension for nebulization,one administration b.i.d. for 14 days; placebo 2 ml suspension for nebulization, one administration b.i.d. for 14 days
Intervention type(s): Drug; Drug
Intervention MeSH terms: Beclomethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy of Inhalation of Essential Oil on the Reduction of Inhalants Craving
Condition: Inhalants Craving
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 3

Summary: 
      Inhalants, which are neurotoxic central nervous system (CNS) suppressants, are frequently
      abused by young adults. Unlike other CNS depressants, including alcohol and opiates, no
      treatment is currently approved for inhalants dependence. In this report, a novel approach of
      substitution treatment for inhalants addiction was explored in a double-blinded, randomized,
      controlled crossover design to examine the effects of inhalation of essential oil (EO) and
      perfume (PF) on the reduction of cue-induced craving for inhalants in a cohort of thirty-four
      Thai males with inhalants dependence. The craving response was measured by the modified
      version of Penn Alcohol Craving Score for Inhalants (PACS-inhalants)
    


Intervention name(s): Essential oil; Perfume; Cue-induced inhalants craving
Intervention type(s): Combination Product; Combination Product; Behavioral
Intervention description(s): To inhale the essential oil in an air-conditioned room, the container was flipped over to soak the roll-on cap that was then rolled-on circularly at the right mid-palm of the subject at 2 centimeter in diameter for 5 cycles.; To inhale the perfume in an air-conditioned room, the container was flipped over to soak the roll-on cap that was then rolled-on circularly at the right mid-palm of the subject at 2 centimeter in diameter for 5 cycles.; Exposing individuals with a set of 12 pictures for one-minute (e.g., 5 second display per picture) every five minutes for three sets in total followed by another three sets of neutral/relaxing pictures of nature.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Serological Response to Porcine Circovirus Type 1 (PCV-1) and PCV-1 DNA in Stools of Infants Following Administration of Rotarix™
Condition: Rotavirus Infection; Evidence of PCV-1 Replication and/or Immune Response to the PCV-1 in HRV Vaccinated Infants
MeSH terms: Rotavirus Infections
Study type: Observational

Summary: 
      This study aims to test the clinical samples (stool and serum) previously collected during
      clinical development of HRV vaccine, to identify if there is any evidence of PCV-1
      replication and/or immune response to the PCV-1 in vaccinated infants.
    

Detailed description: 
      Serum and stool samples collected from 4 clinical trials previously conducted for HRV vaccine
      (Rotarix™) are used in this study.
    

Intervention name(s): Stool sample; Serum sample
Intervention type(s): Procedure; Procedure
Intervention description(s): Stool samples collected at pre-determined time points in previous studies will be analysed to detect the presence of PCV-1 DNA and pattern of detection.; Serum samples collected at pre and post vaccination time points in previous studies will be assessed for Anti-PCV-1 antibody.
Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Infants aged 6 to 12 weeks from 4 previously conducted clinical trials, who received 2 or 3
        doses of either Rotarix™ or Placebo
      
Biospecimen description: 
      Serum and stool samples
    
Keywords: Laboratory evaluations; infants; Porcine circovirus type 1 (PCV-1); serologic response; human rotavirus (HRV) vaccine