bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Avocado vs. Usual Diet on Skin Aging
Condition: Skin Inflammation
MeSH terms: Dermatitis; Inflammation
Study type: Interventional

Summary: 
      This clinical trial aims to assess the effect of providing one avocado per day on skin health
      in comparison with a control group maintaining their habitual diets. Participants will be
      randomly assigned to one of two equally sized groups. Both groups will be instructed to
      continue to follow their habitual diet but the intervention group will receive one avocado
      per day. Participants will be followed for outcomes for a four-month period.
    

Detailed description: 
      This study will be a randomized, parallel group comparison of daily avocado consumption vs.
      habitual diet. The study will be carried out in accordance with the guidelines of the Human
      Subjects Protection Committee of the University of California, Los Angeles. All subjects will
      give written informed consent before the study begins.

      At screening, informed consent and HIPAA authorization will be reviewed and signed. A medical
      history will be obtained. Enrollment will be reviewed by the study physician according to
      inclusion and exclusion criteria. Skin type and response to UVB will be assessed.

      At baseline, participants will undergo skin testing. Subjects will consume 1 avocado a day
      (Hass Avocado) or maintain habitual diet (up to 2 avocados/month) daily for 16 weeks. Skin
      will be assessed at weeks 0, 8 and 16. Each group will have 20 subjects as calculated by
      power analysis. Two additional subjects for each group will be recruited for possible
      dropouts and a total of 22 subjects will be recruited for each group.
    

Intervention name(s): Avocado; Habitual diet
Intervention type(s): Other; Other
Intervention description(s): Subjects will eat one avocado in addition to their usual diet; Subjects will eat their usual diet
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomly assigned to one of two equally sized groups.
Masking: None (Open Label)
Primary purpose: Prevention
Evaluation of the Efficacy and Safety of the Fixed-dose Combination Sofosdac® 400mg/60mg in Patients With Chronic Hepatitis C (HCV)
Condition: Chronic Hepatitis c
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Observational

Summary: 
      A multicentric, observational, open-design study conducted to evaluate the efficacy and
      safety of Sofosdac® 400mg/60mg tablets treatment in 100 patients with chronic hepatitis C
      (HCV)
    

Detailed description: 
      BEKER laboratories developed the generic drug Sofosdac® 400 mg/60 mg Tablets as fixed dose
      combination that contains two direct antiviral agents (400 mg Sofosbuvir and 60 mg
      Daclatasvir) known to be pangenotypic in order to fulfill WHO plan to eradicate HCV by 2030.
      BEKER conducted an observational clinical trial to evaluate the efficacy and safety of FDC
      Sofosdac® 400 mg/60 mg treatment in Algerian patients with chronic hepatitis C (HCV).
    

Intervention name(s): Sofosdac®
Intervention type(s): Combination Product
Intervention description(s): Once daily fixed-dose combination of 400 mg Sofosbuvir and 60 mg Daclatasvir
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The subjects in the study were enrolled from five centers (primary care facilities) across
        different regions in the country; East, Center and West of Algeria.
      
Keywords: HCV; Cirrhotic; non-cirrhotic; sofosdac; sofosbuvir; daclatasvir; fixed-dose combination; FDC; hepatitis C; pangenotypic; genotype
Efficacy Study of Diacerein on Glycemic Control and Liver Fat in Type 2 Diabetes Subjects
Condition: Diabetes Mellitus, Type 2; Non-alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is conducted to test the hypothesis that in uncontrolled type 2 diabetic adults
      treatment with diacerein will improve glycemic control and will reduce liver fat within a 24
      month period.
    

Detailed description: 
      Background: Recently, knowledge about diacerhein, an anthraquinone drug with powerful
      anti-inflammatory properties, revealed that this drug improves insulin sensitivity, mediated
      by the reversal of chronic subclinical inflammation. Amongst the numerous pathogenetic
      factors, oxidative stress and apoptosis of hepatocytes initiate many inflammatory processes
      and are involved in the progression of Non alcoholic fatty liver disease.

      Aims:The aim is to evaluate the effect of treatment with diacerein in improvement of glycemic
      parameters (mean glycated hemoglobin, fasting blood sugar) and reduction of liver fat
      fraction.

      Methods:Two-hundred patients will be randomly allocated either to treatment with diacerein
      plus their usual therapeutic regimen or to placebo for 24 months. Clinic, laboratory
      evaluation (including glycated hemoglobin, fasting blood sugar, creatinine, ferritin,
      aspartate aminotransferase (AST), alanine aminotransferase (ALT), g-glutamyl transpeptidase,
      alkaline phosphatase, bilirubin, albumin, prothrombin time, platelet count, total
      cholesterol, high-density and low-density lipoprotein cholesterol and triglycerides and
      urinary albumin excretion rate no 24-hour urine collection) will be performed before and
      every 3 months until the end of study. Pro-Inflammatory cytokines, adiponectin and
      cytokeratin-18 were measured before, at 12 months and at the end of study. Liver fat fraction
      measurement using controlled attenuation parameter (CAP) by transient elastography.
      (Fibroscan) will be performed before and after the 12 and 24-month treatment, with the
      observers blinded to the allocation group.
    

Intervention name(s): Diacerein; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): All subjects will be given diacerein with a starting dose of 50 mg in one tablet once daily for 2 weeks. After 2 weeks, they will be given diacerein 50 mg in one tablet twice daily for the duration of sudy.; Sugar pill manufactured to mimic Diacerein
Other intervention name(s): Artrodar; Artifit; Acert
Intervention MeSH terms: Diacerein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fat liver; Diabetes; Diacerein; Transient elastography; Treatment
Soy-Based Meal Replacement in Helping Women With Stage I, Stage II, or Stage III Breast Cancer in Complete Remission Lose Weight
Condition: Breast Cancer; Obesity
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      RATIONALE: A diet using a soy-based meal replacement may help survivors of breast cancer lose
      weight and improve their quality of life.

      PURPOSE: This clinical trial is studying how well a soy-based meal replacement works in
      helping women with stage I, stage II, or stage III breast cancer in complete remission lose
      weight.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the ability to recruit survivors of estrogen receptor/progesterone receptor
           (ER/PR)-negative stage I-III breast cancer to participate in a 3-month, soy-based,
           meal-replacement (Almased®) weight loss intervention.

        -  Assess the patient's ability to adhere to this intervention protocol.

        -  Measure changes in anthropometrics (body weight, bioelectrical impedance, waist
           circumference) and biomarkers (serum levels of glucose, insulin, highly specific
           C-reactive protein, insulin-like growth factor, insulin-like growth factor binding
           protein-3, lipids).

        -  Measure changes in health-related quality of life.

      OUTLINE: This is a prospective, longitudinal, pilot study.

      Patients undergo goal-oriented, cognitive-behavioral therapy comprising group counseling
      weekly for 3 weeks and individual counseling once a month. Weight loss interventions include
      behavioral techniques, dietary modification (using a portion-controlled diet and soy-based
      meal-replacement [Almased®] once or twice daily), physical activity (≥ 15 minutes per day, 6
      days a week), and social support. Weight loss is monitored weekly and patients complete daily
      logs of dietary intake and physical activity. Therapy continues for 12 weeks.

      Health-related quality of life is assessed at baseline and then weekly for 12 weeks.

      Patients undergo blood draws at baseline and at 12 weeks for analysis of C-reactive protein,
      glucose, insulin, insulin-like growth factor (ILGF), and ILGF-binding protein-3.

      PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
    

Intervention name(s): behavioral dietary intervention; exercise intervention; soy isoflavones; soy protein isolate; counseling intervention; educational intervention; psychosocial assessment and care; quality-of-life assessment
Intervention type(s): Behavioral; Behavioral; Dietary Supplement; Dietary Supplement; Other; Other; Procedure; Procedure
Primary purpose: Supportive Care
Keywords: stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; obesity
Irofulven in Treating Patients With Recurrent or Persistent Ovarian Epithelial or Primary Peritoneal Cancer
Condition: Primary Peritoneal Cavity Cancer; Recurrent Ovarian Epithelial Cancer
MeSH terms: Carcinoma, Ovarian Epithelial; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      Phase II trial to study the effectiveness of irofulven in treating patients who have
      recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer. Drugs used in
      chemotherapy use different ways to stop tumor cells from dividing so they stop growing or
      die.
    

Detailed description: 
      OBJECTIVES:

      I. Determine the antitumor activity of irofulven in patients with persistent or recurrent
      platinum-sensitive ovarian epithelial or primary peritoneal cancer.

      II. Determine the toxicity of this drug in these patients.

      OUTLINE:

      Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 21 days
      in the absence of unacceptable toxicity or disease progression.

      Patients are followed at approximately 30 days, every 3 months for 2 years, and then every 6
      months for 3 years.

      PROJECTED ACCRUAL: Approximately 22-60 patients will be accrued for this study within at
      least 6 months.
    

Intervention name(s): irofulven
Intervention type(s): Drug
Intervention description(s): Given IV
Other intervention name(s): 6-hydroxymethylacylfulvene; HMAF; MGI 114; MGI-114
Intervention MeSH terms: Irofulven
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effectiveness of an On-line Training Program on Hospital Medical Staff to Improve Fire Knowledge
Condition: Fire
Study type: Interventional

Summary: 
      Objective: To investigate the effectiveness of an online training program on medical staff in
      five public hospitals located in Sichuan, Yunnan, Hubei, and Fujian Provinces of China, on
      improving fire knowledge.

      Methods: Participants will be randomly divided into control (receiving non-fire video
      training) and intervention (receiving hospital fire video training) groups. All participants
      will complete a questionnaire of fire knowledge before and after receiving the training.

      Hypothesis: If the online training is effective, it can be promoted as a convenient and
      effective use of training and be promoted to other hospitals.
    


Intervention name(s): Hospital fire video training; Non hospital fire video training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will watch a video about hospital fire training which last for 30 minutes; Participants will watch a video about volcanic eruption which last for 30 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Keywords: Disaster; Training
Combination Chemotherapy Followed by Surgery in Treating Patients With Localized Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug and giving chemotherapy before surgery
      may shrink the tumor so that it can be removed during surgery.

      PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy followed by
      surgery in treating patients who have localized prostate cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the 5-year freedom from prostate-specific antigen (PSA) recurrence in patients
           treated with this regimen.

        -  Define the maximum tolerated dose of neoadjuvant docetaxel and mitoxantrone followed by
           prostatectomy in patients with high-risk localized prostate cancer. (Phase I completed
           as of 2/15/02)

        -  Determine the toxicity of this regimen in these patients.

        -  Determine the PSA response rate and pathologic response rate in patients treated with
           this regimen.

        -  Determine the clinical response in patients treated with this regimen.

        -  Determine the overall survival of patients treated with this regimen.

        -  Determine the surgical margin status at time of prostatectomy in patients treated with
           this regimen.

      OUTLINE: This is a dose-escalation study of mitoxantrone. (Phase I completed as of 2/15/02)

      Patients receive neoadjuvant docetaxel and mitoxantrone weekly on weeks 1-3. Treatment
      repeats once a week for a total of 4 courses.

      Patients receive escalating doses of mitoxantrone until the maximum tolerated dose is
      determined. (Phase I completed as of 2/15/02)

      Patients undergo prostatectomy 2-4 weeks after completion of neoadjuvant chemotherapy.

      PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
    

Intervention name(s): docetaxel; mitoxantrone hydrochloride; conventional surgery
Intervention type(s): Drug; Drug; Procedure
Intervention description(s): 35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule.; Initial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks.; Prostatectomy will be scheduled 2 - 4 weeks after the last dose of chemotherapy.
Intervention MeSH terms: Docetaxel; Mitoxantrone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the prostate; stage II prostate cancer; stage III prostate cancer
A Dose Titration Study of CPC-201 in Patients With Dementia of Alzheimer's Type
Condition: Dementia of Alzheimer's Type
MeSH terms: Dementia; Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase II, ascending dose study of CPC-201 in patients with dementia of Alzheimer's
      type to determine the optimal dose titration schedule.
    

Detailed description: 
      This is a Phase II, ascending dose study of CPC-201 in patients with dementia of Alzheimer's
      type to determine the optimal dose titration schedule. The study involves a step wise cohort
      design in two different patient populations: Group 1 will comprise of patients who have been
      treated with low dose of CPC-201(5 or 10 mg/day) (given once daily) for at least 4 weeks just
      prior to Day1. Group 2 will consist of patients who have never been treated with CPC-201
      before or who have not received any other AChEI for the past 6 months.

      In this study, CPC-201 dose will be increased at weekly intervals, in accordance with the
      schedules given below, to its first intolerable dose (FID) or maximum allowed dose (MAD) of
      60 mg/day (40mg/day for Cohort 3c) together with solifenacin 15 mg/day.

      Cohort 1 1st week: 20mg 2nd week: 30mg 3rd week: 40mg 4th week: 50mg 5th week: 60mg Cohort 2*
      1st week: 20mg 2nd week: 40mg 3rd week: 60mg Cohort 1b 1st - 2nd week: 10mg 3rd week: 20mg
      4th week: 30mg 5th week: 40mg 6th week: 50mg 7th week: 60mg Cohort 3c* 1st week: 10mg 2nd
      week: 15mg 3rd week: 20mg 4th week: 25mg 5th week: 30mg 6th week: 35mg 7th week: 40mg

      *: The dose titration schedule of Cohort 2 and 3 may be altered based on Cohort 1 result.

      Patients will be enrolled in Cohort 2 only when patients enrolled in Cohort 1 have safely
      completed titration. Similary, patients will be enrolled in Cohort 3, only when patients
      enrolled in Cohort 2 have safely completed titration.

      Patients reaching their FID or having completed one week treatment with donepezil 40mg/day,
      have two options.

      Option 1: Patient will be allowed to immediately enter a long term extension at their Maximum
      tolerated dose (MTD) or MAD.

      Option 2: Patients may choose not to enter the long term extension, in which case the
      Investigator will decide whether the patient should discontinue high dose of donepezil
      without down-titration, or whether donepezil should be downtitrated to their own standard of
      donepezil dose.
    

Intervention name(s): Donepezil; Solifenacin
Intervention type(s): Drug; Drug
Intervention description(s): Donepezil dose increased at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) together with solifenacin.; Donepezil dose increased at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) together with solifenacin.
Intervention MeSH terms: Donepezil; Solifenacin Succinate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Study to Assess the Effect of Fluvoxamine and Smoking on Pharmacokinetics ( the Movement of Drugs Within the Body) of AZD4635 in Healthy Volunteers
Condition: Healthy Volunteer/DDI Study
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a Phase I, open-label, non-randomized, 2-period, fixed-sequence study in
      healthy volunteers who are either smokers or non-smokers, performed at a single Clinical
      Unit.
    

Detailed description: 
      The study will comprise:

        -  A screening period of up to 28 days;

        -  Two treatment periods lasting a total of 17 days from admission to the Clinical Unit
           (Day -1) to discharge (Day 16). During each treatment period subjects will receive a
           single dose of AZD4635 under fasting conditions. Period 1 is designed to evaluate the
           pharmacokinetics (PK) of AZD4635 in healthy smokers and non-smokers. Period 2 is
           designed to evaluate the effect of fluvoxamine on the PK of AZD4635 in healthy smokers
           and non-smokers.

        -  A follow-up call will take place between 6 to 9 days after the last dose of fluvoxamine,
           to ensure the well-being of the subjects. Completion of the last follow-up call or
           unscheduled follow-up visit will be considered the end of the study.

      Each subject will be involved in the study for a maximum of 53 days.
    

Intervention name(s): AZD4635; Fluvoxamine
Intervention type(s): Drug; Drug
Intervention description(s): During each treatment period subjects will receive a single dose of AZD4635 under fasting conditions.; Daily oral single doses of fluvoxamine are planned to be administered to healthy volunteers in Treatment Period 2.
Intervention MeSH terms: Fluvoxamine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: The study is two-period, fixed sequence study in healthy volunteers who are either smokers or non-smokers. Twenty-eight subjects are planned to be enrolled; 14 subjects who are smokers and 14 subjects who are non-smokers. Enrolling 28 subjects will ensure that at least 12 subjects each from the smoking and the non-smoking populations are evaluated in this study.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CYP1A2 Inhibitor; CYP1A2 Inducer; Pharmacokinetics; Adenosine 2A receptor (A2AR) antagonist
Icotinib or Whole Brain Irradiation in EGFR-mutant Lung Cancer
Condition: Brain Metastasis; Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis; Brain Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      EGFR-TKI is good for the patients with EGFR-mutant non-small cell lung cancer.We design this
      clinical trail to confirm if the efficacy of Epidermal Growth Factor Receptor Tyrosine Kinase
      Inhibitor(EGFR-TKI )(ICOTINIB) is better than whole brain irradiation for the patient with
      EGFR-mutant non-small cell lung cancer.
    

Detailed description: 
      no available
    

Intervention name(s): whole brain radiation(WBI); Icotinib
Intervention type(s): Radiation; Drug
Intervention description(s): WBI (30Gy/3Gy/10 fractions) plus concurrent or sequential chemotherapy for 4-6 cycles; administered orally at a dose of 125 mg 3 times daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: EGFR mutant
Safety Study of Local Administration of Autologous Bone Marrow Stromal Cells in Chronic Paraplegia
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to confirm the security, and detect the effect of the local
      administration in damaged nervous tissue, of autologous bone marrow stromal cells.
    

Detailed description: 
      It is a clinical trial phase I, single center, non-randomized, uncontrolled, open prospective
      follow-up of a cohort of patients with chronic spinal cord injury (SCI) who were treated with
      autologous stromal cells of the bone marrow administrated locally (subarachnoid and
      intramedullar) by intrathecal microinjection and three months later, by lumbar subarachnoid
      administration. The minimum follow-up duration for each patient is 12 months after the first
      administration, or until death, if it occurs it before.
    

Intervention name(s): Mesenchymal stromal cell therapy
Intervention type(s): Biological
Intervention description(s): Stem cells administration locally
Other intervention name(s): BMMSCs= Bone Marrow Mesenchymal Stem Cells
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: neurophysiological parameters improvement; spinal cord injury; biology therapy