bioihbjkbjnl/mcl2 huggingface dataset:
Lapatinib and Epirubicin in Treating Patients With Metastatic Breast Cancer. ICORG 06-30
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth. Drugs used in chemotherapy, such as epirubicin, work in different
      ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Giving lapatinib together with epirubicin may kill more tumor cells.

      PURPOSE: This phase I trial is studying the side effects and best dose of epirubicin when
      given together with lapatinib in treating patients with metastatic breast cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To assess the safety and tolerability of fixed-dose lapatinib ditosylate in combination
           with epirubicin hydrochloride in patients with metastatic breast cancer.

        -  To determine the optimally-tolerated regimen in these patients.

      Secondary

        -  To determine the clinical efficacy of this regimen in these patients.

        -  To analyze pharmacokinetic data of this regimen.

        -  To determine biomarkers that correlate with clinical benefit or response to lapatinib
           ditosylate in these patients.

      Tertiary

        -  To identify tumor-derived or blood-derived biomarkers that correlate with or are
           predictive of clinical response or benefit to lapatinib ditosylate in these patients.

        -  To determine the levels of IGF-IR and phosphorylated IGF-IR in tumor tissue.

        -  To determine the expression pattern of the proteins associated with drug resistance that
           may be clinically active in these patients.

      OUTLINE: This is a multicenter, dose-escalation study of epirubicin hydrochloride.

      Patients receive oral lapatinib ditosylate followed by epirubicin hydrochloride IV over 15-30
      minutes on day 1. Treatment repeats every 3 weeks for up to 7 courses in the absence of
      disease progression or unacceptable toxicity.

      Blood samples are collected periodically for pharmacokinetic analysis via liquid
      chromatography-mass spectometry (LC-MS).

      After completion of study therapy, patients are followed at 28 days and then every 3 months
      thereafter.
    

Intervention name(s): epirubicin hydrochloride; lapatinib ditosylate; biomarker analysis; immunohistochemistry staining method; liquid chromatography; mass spectrometry
Intervention type(s): Drug; Drug; Other; Other; Other; Other
Intervention MeSH terms: Epirubicin; Lapatinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IV breast cancer; recurrent breast cancer
Effects of Low Dose Naltrexone in Fibromyalgia
Condition: Fibromyalgia; Persian Gulf Syndrome
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Persian Gulf Syndrome
Study type: Interventional

Summary: 
      Low Dose Naltrexone (LDN) has been reported anecdotally to reduce the symptoms of
      Fibromyalgia, a Chronic Multisystem Illness. The drug may work by regulating natural
      pain-reducing systems. In this study, we will administer both LDN and placebo to a small
      group of individuals with Fibromyalgia and Gulf War Syndrome, both Chronic Multisymptom
      Illnesses, to assess the drug's efficacy in treating the condition.
    

Detailed description: 
      This study will be a placebo-controlled, double-blind, cross-over drug tria. Patients with
      Primary Fibromyalgia or Gulf War Syndrome will be recruited from the Stanford University Pain
      Management Center and the surrounding community. Participation in the study will cover 22
      weeks. Participants will attend a laboratory session 12 times for progress checkups, and will
      complete daily measures of symptoms.
    

Intervention name(s): Low Dose Naltrexone; Placebo - sugar pill
Intervention type(s): Drug; Drug
Intervention description(s): 3-4.5mg Naltrexone once daily; Placebo pill once daily
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Quality of Life in Women
Condition: Quality of Life; Women Health; Social Interaction
Study type: Interventional

Summary: 
      300 women will be evaluated in this study. Their quality of life, level of physical activity,
      Social Functioning, levels of depression and musculoskeletal status will be assessed.
    

Detailed description: 
      Many factors affects quality of life in women. In the literature, factors affecting the
      quality of life such as diseases, working conditions and psychological factors of women have
      been investigated in different diseases. However, there was no study investigating the
      factors affecting quality of life for a sample of adult female individuals. Therefore, the
      aim of our study is to investigate the effect of social, psychological and physical variables
      that we think may affect the quality of life in women.
    

Intervention name(s): Quality of life assessment
Intervention type(s): Other
Intervention description(s): Quality of life will be assessed with Nottingham Health Profile
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: quality of life; depression; anxiety; social function
Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses of BIRB 1017 BS as a Solution in PEG 400 / 26% Ethanol Administered to Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to assess safety, tolerability and pharmacokinetics of BIRB 1017 BS in single rising
      oral doses of 5 to 800 mg in a polyethylene glycol 400 (PEG 400) / 26% ethanol solution in
      healthy male subjects
    


Intervention name(s): BIBR 1017 BS powder; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): PEG 400
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Age-dependent Effects of Flavanols on Vascular Status
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Epidemiological studies suggest that certain foods rich in flavanols, including cocoa
      products, red wine, and tea, are associated with decreased cardiovascular mortality and
      morbidity. Dietary interventional studies have corroborated this finding and showed that
      flavanols can acutely and after sustained ingestion improve surrogate markers of
      cardiovascular risk including endothelial function. Endothelial dysfunction is the key event
      in the development and progression of cardiovascular disease. Aging is the major
      non-modifiable cardiovascular risk factor associated with progressive decline in endothelial
      function, vascular stiffening and increase in blood pressure. We hypothesize that flavanols
      can counteract age-dependent vascular changes by interacting with key mechanisms, most
      prominently endothelial function.
    


Intervention name(s): Flavanol rich intervention; Flavanol free control
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Flavanol intervention drinks contain (400 mg flavanols) flavanol rich drink 2 x 400 mg 2 times a day over 2 weeks; Calorically, micro- and macronutrient matched control drink free of flavanols flavanol free drink 2 times a day over 2 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: flavanols; age related cardiovascular effects
Prospective Phase II Trial on Prophylactic Perihepatic Lymphadenectomy in Patients With Colorectal Cancer With Liver Metastasis
Condition: Colorectal Cancer With Liver Metastasis
MeSH terms: Colorectal Neoplasms; Neoplasm Metastasis; Liver Neoplasms
Study type: Observational

Summary: 
      Objective: To evaluate the role of regional lymphadenectomy in patients with colorectal
      cancer liver metastasis. Background: Lymph node status is 1 of the most important prognostic
      factors in oncologic surgery; however, the role of lymph node dissection remains unclear for
      colorectal cancer liver metastasis.
    

Detailed description: 
      Lymph node status is a definite prognostic factor in oncologic surgery and significantly
      affects long-term survival, as reported by the tumor staging system of the International
      Union Against Cancer (IUCC), which is the most widespread classification of malignant tumors
      worldwide. Regional lymphadenectomy is already the standard procedure that completes hepatic
      resection in the case of carcinoma arising from the extrahepatic bile duct. However, the
      indication, extent, and role of lymph node excision are still a matter of discussion, and no
      clear guidelines exist in patients with colorectal cancer liver metastasis.
    

Intervention name(s): perihepatic lymphadenectomy
Intervention type(s): Procedure
Intervention description(s): Hepatic pedicle lymph node dissection according to the protocol of the prospective multicentric study.Namely the six main groups of lymph nodes removed (HA,hepatic artery; CA, celiac axis; BD, common bile duct).
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Biopsy confirmed colorectal cancer with liver metastasis
      
Keywords: colon neoplasm, rectal neoplasm, liver metastasis
Safety of Paracetamol as Antipyretic in Treatment of Dengue Infection in Adults
Condition: Dengue; Transaminitis
MeSH terms: Dengue
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether regular dosage of paracetamol causes
      transaminitis (hepatitis) and evaluate its potency in the treatment of dengue infection.
    


Intervention name(s): Paracetamol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Paracetamol 500 mg x 1 tablets according to patient's body weight; Placebo 500 mg x 1 tablets according to patient's body weight
Other intervention name(s): Acetaminophen
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Paracetamol
Efficacy of Prostate Seed Implantation for Local Control of Early Stage Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Observational

Summary: 
      The primary goal of this project is to evaluate the efficacy of prostate seed implantation
      for the treatment of early stage prostate cancer for patients treated at Summa Health
      System/Akron City Hospital and Salem Community Hospital.
    

Detailed description: 
      Charts of early stage prostate cancer patients receiving prostate seed implants with or
      without external beam radiotherapy and/or hormonal therapy will be reviewed and abstracted.
      The abstracted data will include pathology reports including Gleason score and T stage, PSA,
      treatment assignment and dosimetry parameters including dose and percent compliant with
      established criteria based on guidelines established by the American Brachytherapy Society.

      A database will be developed for capture of the abstracted data. Outcomes will be determined
      based on PSA levels at 2 and 5 years after prostate seed implantation. The role of hormonal
      therapy with prostate seed implantation and outcomes will be evaluated. The outcomes will be
      compared to national statistics.
    

Observational model: Ecologic or Community
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Prostate seed implantation for the treatment of early stage prostate cancer
      
Keywords: seed implantation
Effect of Combination Therapy With Two Drugs (Colesevelam and Ezetimibe) in Patients With High Cholesterol
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 4

Summary: 
      Assess the efficacy of WelChol® plus Zetia® in treating patients with high cholesterol
    


Intervention name(s): Colesevelam Hydrochloride; Ezetimibe; Simvastatin
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Simvastatin; Ezetimibe; Colesevelam Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Safety; Efficacy; WelChol®; Zocor®; Zetia®
The Effect o f Hepatic Impairment on the Pharmacokinetics and Pharmacodynamics of Betrixiban, an Oral FXa Antagonist
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Single center, prospective open label PK and PD study of betrixaban in subjects with mild and
      moderate hepatic impairment vs healthy volunteers.
    


Intervention name(s): Betrixaban
Intervention type(s): Drug
Intervention description(s): 80 mg capsule
Intervention MeSH terms: Betrixaban
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Rectovaginal Fistula in Post-Radiotherapy Advanced Cervical Cancer Patients
Condition: Locally Advanced Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms; Rectovaginal Fistula; Fistula
Study type: Observational

Summary: 
      To investigate the associated risk factors of rectovaginal fistula
    

Detailed description: 
      To investigate the associated risk factors of rectovaginal fistula in cervical caner patients
      after radiotherapy
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        To present cases who developed rectovaginal fistulas after radiotherapy
Gemigliptin and Biomarkers of Kidney Injury and Vascular Calcification
Condition: Diabetic Nephropathies
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Calcinosis; Vascular Calcification
Study type: Interventional

Summary: 
      Dipeptidyl peptidase-4 (DPP-4) inhibitors improve glycemic control and contain pleiotropic
      actions on kidney injury, albuminuria and vascular inflammation especially in animal models.
      We plan to evaluate the efficacy of potent DPP4-inhibitors (gemigliptin) in response to these
      aspects in diabetic nephropathy patients.
    

Detailed description: 
      This is a multi-center, prospective, randomized, placebo-controlled trial. A total of 201
      participants were enrolled and randomly assigned to gemigliptin 50 mg daily and standard care
      of diabetes mellitus for 6 months. The changes of coronary calcium score (CAC score),
      cardio-ankle vascular index (CAVI), estimated glomerular filtration rate (GFR), markers of
      vascular calcification and markers of tubular renal injury were evaluated at baseline and 6
      months.
    

Intervention name(s): Gemigliptin
Intervention type(s): Drug
Intervention description(s): We collected baseline data from all participants for demographic characteristics,comorbid conditions and biochemistry indexes.The biomarkers for vascular calcification and renal injury were collected.Baseline CAC score and CAVI were done.The patients then were randomized into 2 groups: Group 1 received gemigliptin 50 mg /day for 6 months in addition to standard treatment ,Group 2 will have standard treatment for diabetes mellitus (DM) and chronic kidney disease (CKD).The patients will be followed up every eight weeks.Fasting plasma glucose ,BUN creatinine and 24 hour urine protein were measured at each study visit.Patients were scheduled for follow-up visits at months 2,4,and 6.After 6 months ,all the blood tests,CAC score and CAVI will be done again.
Other intervention name(s): Treatment group
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Multi-center, prospective, randomized, placebo-controlled trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gemigliptin; Diabetic Nephropathy; Acute Kidney Injury; Vascular Calcification
Shingles: Immune Effects of Tai Chi
Condition: Aging; Herpes Zoster
MeSH terms: Herpes Zoster
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial is to evaluate the effects of Tai Chi Chih versus Health Education
      on shingles immunity in older adults as measured by unstimulated and vaccine-stimulated
      responses. The secondary goal of the study is to determine the effects of Tai Chi Chih versus
      Health Education on measures of health functioning, depressive symptoms, and health behaviors
      in the elderly.
    

Detailed description: 
      Shingles, also known as herpes zoster (HZ), is more common in older persons due to the
      weakening of the immune system with advancing age. Psychosocial stresses in the older adult
      also correlate with the decline in immunity. In addition, preliminary data indicate that the
      presence of depressive symptoms in older adults is associated with a decline in the response
      to varicella zoster virus (VZV) vaccination. Taken together, the untoward effects of age and
      depressive symptoms on VZV immunity raise the question as to whether a behavioral
      intervention might augment VZV specific immunity in the older adult.

      Preliminary data has shown that administration of a relaxation-response based intervention,
      Tai Chi Chih (TCC), results in improvements in health functioning and VZV immunity in older
      adults as compared to a control group. TCC is a slow moving meditation comprised of twenty
      separate standardized movements for use in elderly populations. By standardization of
      training and practice schedules, TCC offers an important advantage over prior relaxation
      response based therapies. This controlled trial has 3 goals:

        1. determine whether the practice of TCC for 16 weeks influences unstimulated- and
           vaccine-stimulated VZV specific immunity in adults 60 years of age and older;

        2. demonstrate that TCC can produce significant changes in psychological adaptation, health
           behaviors, and health functioning and well-being;

        3. assess whether changes in psychological adaptation, health behaviors, and health
           functioning correlate with changes in VZV immunity following TCC in older adults.
    

Intervention name(s): Tai Chi Chih
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: Shingles; depression; varicella zoster virus; alternative medicine; psychoneuroimmunology
Identifying Strategies to Alleviate Cardiovascular Stress in Coronary Patients During Heatwaves
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional

Summary: 
      The purpose of this study is to determine the optimal cooling strategies to alleviate
      cardiovascular strain of coronary artery disease individuals during a simulated North
      American and Australian heatwave.
    

Detailed description: 
      Globally, heatwaves are occurring more frequently, are of greater intensity and longer in
      duration. The devastating health impacts of extreme heat are increasingly recognized,
      particularly in vulnerable populations, such as adults with coronary artery disease (CAD).
      While the most effective cooling strategy during a heatwave is the use of air conditioning
      (AC), economical concerns can limit AC use among vulnerable populations. In addition,
      widespread AC use places a significant burden on the electrical grid, causing brown-outs and
      black-outs during periods of extreme heat.

      Electric fans offer a cooling strategy with a 50-fold lower power requirement and cost
      compared to AC. However, the efficacy of fan use during heat waves remains contentious. The
      primary objective of this study is to identify the optimal cooling strategy to alleviate
      cardiovascular strain of CAD patients exposed to typical North American heatwave conditions
      (38°C with 60% relative humidity). The secondary objective is to identify the optimal cooling
      strategy to alleviate cardiovascular strain of CAD patients exposed to typical Australian
      heatwave conditions (46°C with 10% relative humidity).
    

Intervention name(s): No intervention; Fan; Skin Wetting; Fan + Skin wetting
Intervention type(s): Other; Other; Other; Other
Intervention description(s): The participant will rest in a seated position.; A fan placed in front of the participant will provide an airflow of 4 m/s throughout the exposure.; Tap water (~18°C) will be applied every 5 minutes to the face, neck, upper and lower arms and upper and lower legs using a spray bottle.; A fan placed in front of the participant will provide an airflow of 4 m/s throughout the exposure. In addition, tap water (~18°C) will be applied every 5 minutes to the face, neck, upper and lower arms and upper and lower legs using a spray bottle.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Pre-operative Tamsulosin and Time to Spontaneous Void After Hysterectomy
Condition: Urinary Retention Postoperative
MeSH terms: Urinary Retention
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to determine if a one time dose of tamsulosin given pre-operatively
      decreases the time to void and the time to discharge after minimally invasive hysterectomy.
    


Intervention name(s): Tamsulosin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will be given Tamsulosin or placebo in the pre-op bay prior to surgery. Post-operatively, time to void and time to discharge from the post-anesthesia care unit will be recorded.; Participants will be given Tamsulosin or placebo in the pre-op bay prior to surgery. Post-operatively, time to void and time to discharge from the post-anesthesia care unit will be recorded.
Intervention MeSH terms: Tamsulosin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention