bioihbjkbjnl/mcl2 huggingface dataset:
Effects of ICA-105665 Using the Intradermal Capsaicin and Ultraviolet B (UV-B) Models in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is; to determine the pharmacodynamic (PD) effects of ICA-105665
      using the intradermal (ID) capsaicin model in healthy male subjects, and to investigate the
      effect of ICA-105665 on inflammatory hyperalgesia using the ultraviolet B (UV-B) model in
      healthy male subjects.
    


Intervention name(s): ICA-105665; Ibuprofen; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects randomized to receive ICA -105665 will receive 200 mg BID; Subjects randomized to receive Ibuprofen will receive placebo to ICA-105665 at all scheduled dosing times on Days 1 to 4 and a single dose of 800 mg Ibuprofen on the morning of Day 4.; Subjects randomized to receive placebo will receive placebo to ICA
-105665 at all scheduled dosing times on Days 1 to 4 and placebo to Ibuprofen on the morning of Day 4.
Other intervention name(s): Cuprofen; orange Syrup BP
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
A Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between YHR1705 and YHR1706
Condition: Dyslipidemia; Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2; Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, open label, multiple-dose, crossover clinical trial to investigate the
      pharmacokinetic drug interaction between YHR1705 and YHR1706 in healty male volunteers
    

Detailed description: 
      This is an open-label, randomized, 6-sequence, 3-period crossover study. Subjects will
      receive multiple oral doses of YHR1705, YHR1706 or YHR1705 + YHR1706 QD for 5 consecutive
      days. There will be a washout of at least 10 days between the last dose in one period and the
      first dose in the subsequent period.
    

Intervention name(s): YHR1705; YHR1706; YHR1705+YHR1706
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days in each period.; Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days in each period.; Subjects will receive multiple oral doses of YHR1705 + YHR1706 QD for 5 consecutive days in each period.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetics of Cyclosporin in Nephrotic Syndrome
Condition: Nephrotic Syndrome
MeSH terms: Nephrotic Syndrome; Nephrosis; Syndrome
Study type: Observational

Summary: 
      The purpose of this study is to evaluate whether there are differences in the
      pharmacokinetics of cyclosporine in remission nephrotic syndrome compared to relapsed disease
      in children.
    

Detailed description: 
      This is a prospective study on ten children using Cyclosporin-A (CSA) microemulsion to treat
      idiopathic nephrotic syndrome (INS), with normal renal function, who achieved complete
      remission with CSA. The objective is to compare the pharmacokinetic (PK) parameters of CSA in
      INS during remission and relapse of the disease. The PK profile of CSA was evaluated with the
      12-hour area under the time-concentration curve (AUC0-12) using seven time-point samples.
      This procedure was done on each patient during remission and relapse with the same CSA dose
      in mg/kg/day. The AUC0-12 was calculated by trapezoidal rule. All PK parameters and the
      resumed 4-hour area under the time-concentration curve (AUC0-4) were correlated with AUC0-12.
      This study is very important because the cyclosporin is a nephrotoxic drug with narrow
      therapeutic window.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children with Iidiopathic nephrotic syndrome followed in the Pediatric Nephrology Unit of
        Instituto da Criança-HCFMUSP
      
Biospecimen description: 
      Whole blood
    
Keywords: cyclosporin; nephrotic syndrome; pharmacokinetics; children
A First Study in Healthy Volunteers of a New Mobile Phone Application Measuring the Eyes Before and After Medication
Condition: Drug Abuse
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      This is a pre-market, explorative, early feasibility, pilot, controlled clinical
      investigation designed to collect initial clinical data on the medical device Previct Drugs.
    

Detailed description: 
      This first study will give valuable information on the feasibility of Previct Drugs function
      to measure pupils and eye movements and to evaluate if there are any changes in the
      pupillometric parameters before and after intake of a medicinal product. It will also provide
      information on the usability of the device. Drug intake will in this first investigation be
      simulated by a controlled single application of commonly therapeutically used medicinal
      products from the following classes of drugs: phenethylamines (D1), benzodiazepines (D2),
      cannabinoids (D3), and opioids (D4).
    

Intervention name(s): Previct Drugs
Intervention type(s): Device
Intervention description(s): Previct Drugs is a new non CE-marked eHealth system intended to be used for future monitoring and treatment of patients with substance use disorder (SUD). Previct Drugs consists of an application (app) to be installed on a smartphone, a web-based careportal to be accessed from a computer by the healthcare professional for administration and access of registered data, and a database for storage, handling, and analysis of reported data. Previct Drugs is intended to be used by healthcare professionals and patients within treatment of SUD.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomized to one out of four arms, i.e., single application of either phenethylamines, benzodiazepines, cannabinoids, or opioids. The investigation aims to enroll 11 subjects, i.e., healthy volunteers, per medicinal product group that have completed the clinical investigation until the telephone follow-up call. For four medicinal products, the total will be 44 subjects. In order to take account for a drop-out rate of 10%, 12 subjects will be included per medicinal product group and in total 48 subjects in the clinical investigation. As this is an early feasibility and explorative investigation, the sample size is not derived from a sample size calculation as no hypothesis is pre-defined.
Masking: None (Open Label)
Primary purpose: Other
Relationship Between Body Weight and Glycohemoglobin
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2; Body Weight
Study type: Observational

Summary: 
      Control of body weight (BW) is important to prevent and manage type 2 diabetes. Regardless of
      the close association, little is understood about the precise relationship between BW and
      glycemic control, which might be of benefit for patients with type 2 diabetes. The
      researchers investigated the correlation between changes in BW and glycemic control in
      patients with type 2 diabetes treated with a diet therapy or pioglitazone.
    


Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        primary care clinic
      
Keywords: body weight; glycohemoglobin
A Study to Assess Efficacy and Safety of Nasacort® Nasal Spray in Comparison With Flixonase® Nasal Spray in Adults Suffering From Perennial Allergic Rhinitis (PAR)
Condition: Rhinitis Allergic
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Objective:

        -  To assess efficacy of Nasacort® (triamcinolone) nasal spray, 55 µg per dose, in
           comparison with Flixonase® (fluticasone) nasal spray, 50 µg per dose, by reflective
           total nasal symptom score (rTNSS) (24 h) after 28 days of treatment compared with
           baseline (0 day of treatment) in adult patients suffering from PAR (perennial allergic
           rhinitis).

      Secondary Objectives:

        -  To evaluate safety of Nasacort® (triamcinolone) nasal spray, in comparison with
           Flixonase® (fluticasone) administered for 28 days by assessment of adverse events
           reports.

        -  To evaluate patient and physician satisfaction after 28 days of treatment by 5-point
           scale.

        -  To estimate improvement of quality of life during the study by mini Rhinoconjunctivitis
           Quality of Life Questionnaire (miniRQLQ).
    

Detailed description: 
      The total study duration per patient will be up to approximately 33 days.
    

Intervention name(s): triamcinolone XRG5029; fluticasone
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form: spray solution
Route of administration: nasal; Pharmaceutical form: spray solution
Route of administration: nasal
Other intervention name(s): Nasacort®; Flixonase®
Intervention MeSH terms: Fluticasone; Triamcinolone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Follow-up Study to Evaluate the Safety and Immunogenicity of a HPV Vaccine (580299) in North America
Condition: Infections, Papillomavirus
MeSH terms: Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      Infection with human papillomavirus (HPV) has been clearly established as the central cause
      of cervical cancer. This study will further evaluate induction of immune memory and
      anamnestic responses in women who previously took part in the primary study (580299/001) and
      follow-up study (580299/007). Subjects were aged 15-25 yrs at the time of entry into the
      primary study and participation in the follow-up study lasted approximately 6 years. In the
      primary and follow-up studies, subjects were protected against HPV-16 and HPV-18 endpoints
      and had sustained antibody responses to both vaccine types over at least 5.5 years of
      follow-up. All subjects from North American study sites that completed the follow-up study
      will be invited to take part in the current study. The study will evaluate the safety and
      immunogenicity of a dose of GSK Biologicals HPV vaccine (580299) in women who had been
      immunologically primed in the primary study.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    


Intervention name(s): Cervarix™
Intervention type(s): Biological
Intervention description(s): Intramuscular injection, one or three doses
Other intervention name(s): GSK Biologicals' HPV Vaccine GSK580299
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HPV vaccine; Cervical cancer; Human papillomavirus infection
Naltrexone in Treatment of Cocaine Dependence - 5
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the efficacy of naltrexone in the treatment of
      cocaine dependence as measured by: 1) decreased urine benzoylecgonine (BE) levels, 2)
      decreased cocaine use by self-report, 3) decreased cocaine craving, and 4) retention in
      treatment.
    

Detailed description: 
      Double-blind, placebo controlled study of the safety and efficacy of naltrexone in treating
      cocaine dependence in a patient sample that initiated the study while in an inpatient setting
      and were then followed-up for 3 months as outpatients.
    

Intervention name(s): Naltrexone
Intervention type(s): Drug
Intervention MeSH terms: Naltrexone
Primary purpose: Treatment
Keywords: cocaine dependence
A Prospective Multi-Center Study Using Laser for the Treatment of Melasma and Lentigines in Asian Skin
Condition: Melasma; Lentigines
MeSH terms: Melanosis; Lentigo
Study type: Interventional

Summary: 
      The purpose of this investigation is to evaluate safety and efficacy of the Cutera enlighten
      dual-pulse duration, dual-wavelength 532nm KTP/1064nm Nd:YAG laser for the treatment of
      melasma and lentigines on the face in Asian skin.
    

Detailed description: 
      This is a multi-center prospective, 2 cohort study in 80 male or female subjects of
      Asian-descent, who desire laser treatment for moderate to severe melasma (all types) or
      lentigines (all types) located on the face. Forty subjects will be enrolled in cohort 1 and
      randomized to either treatment or control arm. Forty subjects will be enrolled for treatment
      of facial lentigines in cohort 2.
    

Intervention name(s): enLighten Laser
Intervention type(s): Device
Intervention description(s): enLighten Laser treatment with dual-pulse width and dual-wavelength
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Investigate the Mass Balance and Biotransformation of SIM0417 in Healthy Adult Chinese Male Participants
Condition: Healthy Male Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a non-randomized, open-label, single-dose, Phase I clinical study to evaluate the
      mass balance and biotransformation, safety and tolerability of SIM0417 in healthy Chinese
      adult male subjects following a single oral administration of SIM0417 in combination with
      ritonavir.
    

Detailed description: 
      This is a single-center, non-randomized, open-label, single-cohort, single-dose, Phase I
      clinical study to evaluate the mass balance, biotransformation, safety, and tolerability of
      SIM0417 following a single oral administration of SIM0417 combination with ritonavir in
      healthy Chinese adult male subjects.

      This study is planned to enroll 6-8 healthy male subjects, each subject will receive SIM0417
      combined with ritonavir administration. SIM0417 is single dosed, and ritonavir is
      administered 12 hours before SIM0417 administration (-12h), at the time of SIM0417
      administration (0h), 12h (12h), and 24h (24h) after SIM0417 administration.

      SIM0417 is administered after meals, ritonavir is administered either in fasting condition or
      after meals.
    

Intervention name(s): SIM0417
Intervention type(s): Drug
Intervention description(s): Single oral dose of 750 mg SIM0417 coadministered with 100 mg ritonavir.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mass Balance
A Study of Famitinib Plus Docetaxel in Patients With Advanced Non-squamous and Non-Small Cell Lung Cancer (NSCLC)
Condition: Non-Small Cell Lung Cancer (NSCLC)
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1

Summary: 
      Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and
      Flt3. Phase I study has shown that the toxicity is manageable.

      This study assessed the safety and maximum tolerated dose of continuous daily treatment with
      Famitinib plus docetaxel (60 mg/m^2, every 3 weeks) in patients with Advanced Non-squamous
      and Non-Small Cell Lung Cancer (NSCLC) to determine the recommended dose for the Phase II
      trial.
    


Intervention name(s): famitinib L + docetaxel; famitinib M + docetaxel; famitinib H + docetaxel
Intervention type(s): Drug; Drug; Drug
Intervention description(s): famitinib 15mg qd + docetaxel 60 mg/m^2; famitinib 20mg qd + docetaxel 60 mg/m^2; famitinib 25mg qd + docetaxel 60 mg/m^2
Intervention MeSH terms: Docetaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pilot Study of Total Body Irradiation in Combination With Cyclophosphamide, Anti-thymocyte Globulin, and Autologous CD34-Selected Peripheral Blood Stem Cell Transplantation in Children With Refractory Autoimmune Disorders
Condition: Systemic Sclerosis; Systemic Lupus Erythematosus; Dermatomyositis; Juvenile Rheumatoid Arthritis; Autoimmune Diseases
MeSH terms: Arthritis; Arthritis, Rheumatoid; Dermatomyositis; Arthritis, Juvenile; Lupus Erythematosus, Systemic; Scleroderma, Systemic; Scleroderma, Diffuse; Autoimmune Diseases; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      OBJECTIVES: I. Determine the safety and long term complications of total body irradiation in
      combination with cyclophosphamide, anti-thymocyte globulin, and autologous CD34-selected
      peripheral blood stem cell (PBSC) transplantation in children with refractory autoimmune
      disorders.

      II. Determine the efficacy of this treatment regimen in these patients. III. Determine the
      reconstitution of immunity after autologous CD34-selected PBSC transplantation in these
      patients.

      IV. Determine engraftment of autologous CD34-selected PBSC in these patients.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a multicenter study. Patients receive filgrastim (G-CSF)
      subcutaneously daily until peripheral blood stem cell (PBSC) collection is completed. CD34+
      cells are separated from the rest of the PBSCs.

      Patients undergo total body irradiation twice daily on days -5 and -4. Patients receive
      anti-thymocyte globulin IV on days -5, -3, -1, 1, 3, and 5 and cyclophosphamide IV on days -3
      and -2. CD34-selected PBSCs are reinfused on day 0. Patients receive G-CSF IV daily beginning
      on day 0 and continuing until blood counts recover.

      Patients are followed annually for 5 years and then every 5 years thereafter.
    

Intervention name(s): Stem Cell Transplantation; CD34 selection
Intervention type(s): Procedure; Device
Intervention description(s): Participants will receive a stem cell transplantation along with irradiation and the drugs anti-thymocyte globulin, cyclophosphamide, and filgrastim as noted in the text of this record.; CD34+ cells are separated from the rest of the peripheral blood stem cells.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: arthritis & connective tissue diseases; dermatomyositis; immunologic disorders and infectious disorders; juvenile rheumatoid arthritis; rare disease; systemic lupus erythematosus; systemic sclerosis
Enhanced Recovery After Surgery for SPK Transplantation Recipients
Condition: Transplant Complication; Diabetic Nephropathy; Perioperative/Postoperative Complications
MeSH terms: Diabetic Nephropathies; Postoperative Complications
Study type: Interventional

Summary: 
      108 patients underwent elective SPK surgery were randomly divided into ERAS group (E) and
      routine care group (T). The ERAS group was consisted of evidenced-based systematic
      optimization approaches, while the control group received routine care.
    

Detailed description: 
      Primary results: the postoperative length of stay (LoS) and hospitalization costs; second
      results: post-operative analgesia score (NRS) , the incidence of post-operative nausea and
      vomiting (PONV) , urinary catheter removal time by 7 days , post-operative gastric tube
      indwelling time, the incidence of ambulation within 6 days . the dosage of dobutamine using ,
      the dosage of norepinephrine using, and the total amount of fluid and urine volume . MAP and
      lactate level . Peak systolic velocity (PSV) and (resistance index) RI of grafts were checked
      between two groups.
    

Intervention name(s): Enhanced recovery for SPK recipients
Intervention type(s): Procedure
Intervention description(s): Pre-operative, perioperative and post-operative were consisted of evidenced-based systematic optimization approaches.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: prospective randomized controlled tiral
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: enhanced recovery after surgery, SPK transplantation
Adherence to Mediterranean Diet and Phase Angle
Condition: Mediterranean Diet; Phase Angle
Study type: Observational

Summary: 
      In this cross-sectional observational study the investigators evaluated the association
      between the adherence to the MD and PhA in a sample of adult population, stratified according
      to categories of sex, age, and BMI.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Recruitment strategies included attendance at the outpatient obesity clinics at the
        investigators Department or the outdoor hospital of the Campus Salute. The study is part of
        a large database started in 2010 to investigate the health status of the general population
        of Campania Region as analysed by the free consultation, visit, and diagnostics for people
        coming to the outdoor hospital held in different public squares of the investigators
        Region.