cyrilzakka/clinical-trials huggingface dataset:
DP-R213 Pharmacokinetics Study

A randomized, open-label, crossover, Phase I clinical trial to compare the pharmacokinetics of DP-R213 (Raloxifenel and Cholecaliferol fixed dose combinations) in comparison to each component administered alone in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* IBW ±20%
* signed the informed consent form prior to the study participation

Exclusion Criteria:

* Clinically significant disease
* Previously donate whole blood within 2 months or component blood within 1 month
* Clinically significant allergic disease
* Taken IP in other trial within 3 months
* An impossible one who participates in clinical trial by investigator's decision including laboratory test result
Observational Registry of Treatment Patterns in Castrate-resistant Prostate Cancer (CRPC) Patients

Primary Objective:

* Describe real-life survival of CRPC patients who received first-line docetaxel and have disease progression

Secondary Objective:

* Describe treatment patterns
* Describe the characteristics and outcomes of patients who received second-line taxane-based treatment compared to others
* Describe economic and patient-reported outcomes


Eligibility Criteria:
Inclusion criteria:

* Patients with CRPC progressing during the course of first line docetaxel-based chemotherapy or after at least 3 cycles (equivalent to 225mg/m2) of first line docetaxel-based chemotherapy
* Patient who have given their written consent

Exclusion criteria:

* Current participation in a clinical trial for the second-line treatment of prostate cancer
* Patients having received less than 3 cycles of first line docetaxel-based chemotherapy and discontinued for a reason other than disease progression or toxicity
* Patients having already started a second line treatment

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Evaluation of an Early Screening Test of Chronic Rejection and of Operational Tolerance by MicroArray in Renal Graft (Protocol DPRC Array)

The aim of the study is to explore the possibility to identify, at an early stage after a renal graft and from blood samples collected within first months after graft, a predictive transcriptional profile of long term occurence of graft operational tolerance or chronic rejection.

The aim of the study is to determine an early transcriptional profile of chronic rejection in the transcriptome of mononuclear blood cells. Validation and predictivity of transcriptional analysis will be based on graft function and graft histology one year after transplantation.The other aim is to determine an early transcriptional profile of operational tolerance in the same patients using a DNA chip dedicated including two lists of genes discriminating tolerant patients who are stopped immunosuppressant treatment for over a year.

To allow statistical analysis of 100 patients followed one year after graft, patients not assessable at one year due to early termination of study will be replaced.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 to 65 years old,
* Donor's age ≤ 60 years old,
* Patients receiving a first cadaveric renal graft,
* Patients taking immunosuppressant treatment including an induction with Simulect at day 0 and day 4, FK 506 (Prograf®) associated with Cellcept and steroids (for three months),
* Patients don't taking indispensable anticoagulant treatment.

Exclusion Criteria:

* Patient's age \< 18 or \> 65 years old,
* Donor's age ≥ 60 years old,
* Pregnant women or breast feeding women,
* Patients receiving a retransplantation, a kidney and pancreas graft or a graft from a living donor,
* Patients taking immunosuppressant treatment without FK 506 (Prograf®), Cellcept and steroids.
* Patients with coagulation troubles or taking indispensable anticoagulant treatment,
* No biopsy before graft.
Effect of Good Pain Management (GPM) Ward Program on Moderate to Severe Cancer Pain Patients

This study aims to set up a standardized cancer pain ward - known as the Good Pain Management (GPM) Ward with streamlined assessment and management procedures to act as a pain management model. In particular, it will enforce regular pain assessment from and throughout hospital admission, and treatment protocols introducing the use of strong-opioids in moderate cancer pain patients, following National Cancer Care Network (NCCN) Adult Cancer Pain Guidelines. The GPM ward will be compared against current-practice controlled ward.

This is a double-arm, randomized, multi-center, current practice-controlled study. Approximately 150 cancer pain patients with collecting questionnaires admitted to an inpatient department from 3 national hospitals: Kaohsiung Medical University Hospital, Kaohsiung Municipal Ta-Tung Hospital and Kaohsiung Municipal HsiaoKang Hospital will be invited into this study. Eligible patients will be randomized to one of the following pain control wards in a 1:1 ratio.

* GPM Ward: Good Pain management ward
* Control Ward: Current practice-controlled ward Surveys, pain level measurements and dosage used will be collected in 48±8 hours. The pain management index (PMI) will be assessed as primary objective. The patient satisfaction, outcome questionnaire (APS-POQ) and SF-36 will be assessed in secondary objectives.

Once patient is admitted to the ward and agrees to participate in the study, the patient will be randomly and blindly assigned to either GPM ward or Control Ward. In the Control Ward, patient will receive the current practice of pain management, with less assessment procedure.

This study will investigate the benefits and effect of good pain control on patient outcomes in hospitalized cancer pain patients. The results aim to demonstrate the viability of GPM ward in daily practices and its measurable impact on the patient outcomes including patient treatment satisfaction as well as quality of life.

1. Primary objectives:

   • To assess pain management index (PMI)
2. Secondary objectives:

(1) To assess the satisfaction of pain control during admission (2) To analyze the Patient Outcome Questionnaire (APS-POQ) (3) To analyze the SF-36 Questionnaire

Eligibility Criteria:
Inclusion Criteria:

1. Females and males aged ≥ 20
2. Understand Chinese/Taiwanese and able to finish the questionnaire
3. Alert enough to respond and understand
4. Hospitalized for ≥ 24 hours
5. ECOG ≤ 2
6. Cancer patients with cancer-related pain

Exclusion Criteria:

1. Patient diagnosed with non-cancer pain or unexplained pain
2. Patient with moderate to severe mental disorder
3. Patient receiving operation or invasive procedure within 24 hours before admission
Daptomycin or Vancomycin in Treating Bacteria in the Blood in Patients With Neutropenia Caused By Chemotherapy

RATIONALE: Antibiotics, such as daptomycin and vancomycin, may be effective in treating bacteria in the blood. It is not yet known whether daptomycin is more effective than vancomycin in treating bacteria in the blood in patients with neutropenia caused by chemotherapy.

PURPOSE: This randomized clinical trial is studying daptomycin to see how well it works compared with vancomycin in treating bacteria in the blood in patients with neutropenia caused by chemotherapy.

OBJECTIVES:

Primary

* Compare the safety of daptomycin vs vancomycin in cancer patients with chemotherapy-induced neutropenia and gram-positive bacteremia.
* Compare the efficacy of these drugs, in terms of fever resolution, bacteremia resolution, inflammation indicators reduction, implanted catheter salvage, and reduced need for antifungal therapy, in these patients.

OUTLINE: This is an open-label, randomized, pilot study. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive daptomycin IV over 30 minutes once daily.
* Arm II: Patients receive vancomycin IV over 60 minutes twice daily. Treatment in both arms continues for approximately 7-14 days or until microbiologic failure, unsatisfactory clinical (symptomatic) response, or fever and neutropenia is resolved (absolute neutrophil count ≥ 1,000/mm\^3 on ≥ 2 consecutive days). Patients may be removed from the study if the isolate is found to be sensitive to the original antibiotics or resistant to either of the study drugs.

After completion of study therapy, patients are followed at 6 and 12 weeks.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of a malignancy
* Chemotherapy-induced neutropenia (absolute neutrophil count \< 500/mm\^3)
* Two or more blood cultures positive for gram-positive cocci

  * At least 0.2 colony-forming units/mL on lysis-centrifugation culture
* Currently receiving broad-spectrum antimicrobial therapy appropriate for febrile neutropenia
* No meningitis, endocarditis, osteomyelitis, or pneumonia (by clinical or radiologic criteria)

PATIENT CHARACTERISTICS:

* Life expectancy ≥ 7 days
* No allergy or intolerance to vancomycin or daptomycin
* Creatinine clearance ≥ 30 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for at least 30 days after completion of study treatment
* No underlying myopathy or neurologic disease (e.g., Guillan-Barre or multiple sclerosis)

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No concurrent HMG CoA reductase inhibitors (statins)
* No concurrent gemfibrozil or clofibrate
Comparative Effects of Cognitive and Motor Dual Task Training on Balance and Quality Of Life in Parkinson's Patients

To Compare Effects of Cognitive and Motor Dual Task Training on Balance and Quality Of Life in Parkinson's Patients

This study will be conducted to compare the Comparative Effect of Cognitive and Motor Dual Task Training on Balance and Quality Of Life in Parkinson's Patients. total 20 Patients will be recruited according to the inclusion criteria and data will be collected from the Riphah Rehabilitation center Lahore, Muhammadi Medical trust hospital Lahore. Time Up and Go test (TUG) Parkinsons disease Questionnaire 39 (PDQ-39) will be used as data collection tool. To assess the balance and quality of life in parkinson's patients. Patients will be allocated to intervention group by randomization. After approval from ethical committee, data collection will be started and informed consent will be taken from all patients

Eligibility Criteria:
Inclusion Criteria:

* A stage I-II-III Hoehn and Yahr scale consultant neurologist's diagnosis of Parkinson's disease
* A stable medication schedule both before and during the trial period
* can walk without assistive aid

Exclusion Criteria:

* Other neurological conditions in additions to Parkinson's disease such as CVA, Head injuries, Trauma
* Any Musculoskeletal condition e.g., total knee replacement surgery and rheumatoid arthritis
* Sensory impairments (vestibular dysfunctions)
Online Mindfulness Therapy for Pandemic Fatigue and Resilience in COVID-19 Nurses

This study evaluates online mindfulness therapy's impact on pandemic fatigue and resilience in COVID-19 quarantine ward nurses. Sixty nurses were divided into experimental and control groups, with the experimental group receiving a 6-week online mindfulness course.

This study evaluates the effectiveness of online mindfulness therapy on reducing pandemic fatigue and enhancing resilience among nurses in COVID-19 quarantine wards. Using a repeated-measures quasi-experimental design, 60 nurses were divided into experimental and control groups. The experimental group participated in a 6-week online mindfulness course. Outcomes were measured using pandemic fatigue and resilience questionnaires at the pre-test , three weeks and after six weeks.

Eligibility Criteria:
Inclusion Criteria:

* Over 20 years old.
* Nurses of COVID-19 dedicated wards and dedicated intensive care units.

Exclusion Criteria:

* Difficulty in attending
* less than 80% of the total number of online mindfulness therapy sessions
Plasma and Lung Tissue Concentrations of Linezolid in Septic Shock Patients

The study measures the plasma and bronchoalveolar lavage fluid concentrations of linezolid in septic shock patients comparing with non-septic shock patients to confirm the impact of septic shock on PK/PD of linezolid.

A wide array of pathophysiological changes occurring in severe sepsis and septic shock patients may influence antibiotics' pharmacokinetic (PK) properties. The pharmacokinetics and tissue distributions of linezolid achieving effective concentrations are key factors of successful clinical outcomes. To the best of our knowledge, no observational clinical studies are available on the plasma and bronchoalveolar lavage fluid concentrations of linezolid in septic shock patients. Severe pneumonia patients known or suspected to be caused by Gram-positive pathogens will be considered eligible for the study when the attending physician prescribed linezolid as treatment. The plasma and bronchoalveolar lavage fluid concentrations of linezolid are measured in each group at steady state. In an in vitro PK Model, concentration-time curve is drawn to calculate %T\>MIC or AUC0-24h/MIC. Linezolid pharmacodynamics evaluation should be based on bacterial eradication and clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. between 18 years old and 75 years old;
2. Admitted to the ICU;
3. Expectation, in the opinion of the investigator, that the patients' infection will require ICU stay more than 3 days;
4. Patients diagnosed as severe pneumonia requiring mechanical ventilatory support;
5. Severe pneumonia known or suspected to be caused by Gram-positive pathogens;
6. Expected to treat with linezolid.

Exclusion Criteria:

1. Unable to take bronchoalveolar lavage via bronchofiberscopy;
2. Allergy, hypersensitivity or a serious reaction to linezolid;
3. Treatment with linezolid during the previous 72 hours;
4. Pregnancy.
ONES Grant: CXCL10/CXCR3 Regulation of Ozone-Induced Epithelial Permeability

The purpose of this research study to understand how environmental and genetic factors may be involved in lung function. Study participants will undergo a 1-day screening that includes a blood draw and breathing testing, return for a two-day series of testing to include blood draw, and brief breathing test before and after an inhaled challenge with either filtered air (FA) or ozone (O3). Participants return the next day for a brief breathing test, a blood draw and a procedure called bronchoscopy to evaluate the lung after the challenge. Participants then return 18 - 20 days later to repeat the two-day series of testing to be challenged with the exposure not received on the first series, (FA or O3). Each visit will take about 3 - 3.5 hours. Follow-up phone calls from the study team will occur at 24 hours after each 2-day test series. Total study duration is about one to one-and a half months.


Eligibility Criteria:
Inclusion Criteria:

* Prior enrollment in the NIEHS Environmental Polymorphism Registry located in the greater Raleigh-Durham area
* Wild type or homozygous (female)/hemizygous (male - since sex-linked) expression of the CXCR3 polymorphism rs2280964

Exclusion Criteria:

* Current smokers of tobacco products including e-cigarettes or those with previous smoking history within the prior 5 years
* BMI less than 37 kg/m2
* Pregnant women and women who are presently lactating.
* Subjects that have received antibiotic administration or an upper respiratory infection within the previous 4 weeks
* College and graduate students or employees who are under direct supervision by any of the investigators in this protocol
* Alcohol or illicit substance abuse
* Chronic cardio/pulmonary respiratory disorders or other medical conditions as determined by the investigator
* Increased airway hyperresponsiveness at baseline as measured by a positive methacholine challenge response (methacholine PC20 FEV1 \< 8 mg/ml)
* Subjects will be requested to refrain from antihistamines, nonsteroidal anti-inflammatory agents, antioxidants (e.g. beta-carotene, selenium, and lutein) and supplemental vitamins (e.g. C and E), for 1 week prior to, and during testing.
Real World Study of First Line Crizotinib for ALK Rearranged Non-squamous Non-small Cell Lung Cancer

This study aims to explore the efficacy and safety of Crizotinib as a first-line therapy for advanced non-squamous non-small cell lung cancer with ALK-positive mutations in the real world.

According to the study of P11014 and P1029, Crizotinib is a first-line therapy for advanced non squamous non small cell lung cancer with positive ALK rearrangement.This study aims to explore the efficacy and safety of clozotinib as a first-line therapy for advanced non-squamous non-small cell lung cancer with ALK-positive mutations in the real world. Among them, ALK positive was based on NGS test results, exploring the new drug resistance mechanism of ALK under clozotinib treatment mode and consistency between plasma and tissue detection driving genes, and finally assessing the role of plasma dynamic detection driving gene mutation spectrum in predicting disease progression risk. A retrospective study of 120 patients with advanced NSCLC using clozotinib ALK positive mutation was conducted to observe the efficacy and safety of clozotinib regimen in the real world.

Eligibility Criteria:
Inclusion Criteria:

* ≥18，Pathologically proven ALK positive mutation in advanced non squamous non small cell lung cancer
* ALK rearrangement detection method is NGS and Ventana
* Primary treatment of first diagnosis
* The treatment was Crizotinib 250mg po bid Exclusion Criteria
* Patients received antitumor treatment before
* Patients with contraindication of chemotherapy
* Pregnant or breast feeding women
Treating Patients With a History of Non-Life Threatening Allergic Reaction to Penicillin With Penicillin

The purpose of this study is to examine whether oral challenge with penicillin for patients with a known history of non-life threatening allergic reaction to penicillin is well-tolerated irrespective of skin-testing results

Objective: To examine whether oral challenge with penicillin for patients with a known history of non-life threatening allergic reaction to penicillin is well-tolerated irrespective of skin-testing results long after the event occurred.

Methods: In this prospective, open-label, controlled, multi-clinical trial, 8702 individuals from primary care clinics were screened for penicillin allergy. 169 patients with a history of non-life threatening allergic reaction to penicillin, dating back at least 3 years, were recruited for study. Regardless of the response to penicillin skin testing, patients received the recommended daily dosage of penicillin and amoxicillin on two separate occasions. 2-6 years later a follow-up was conducted to assess the outcomes of further penicillin administration.

Results: 92.9% of the patients had an allergic reaction 6 years or longer before enrollment in the study. Of 272 challenges, 137 were skin-test positive with mild rash in 9 patients (6.6%), and 135 were skin-test negative with similar allergic reaction in 5 (3.7%) (P =.29). At follow-up, 3 of 55 patients (5.5%) who were given a full treatment course of penicillin developed mild skin eruption.

Conclusions: A positive penicillin skin testing of patients with a history of non-life threatening allergic reaction to penicillin occurring 3 years or longer from the event was not associated with a greater prevalence of adverse reactions to oral challenge with penicillin than a negative one. It is of importance to determine whether oral challenge can serve as a diagnostic procedure for this particular group of patients, thereby saving the need for prior penicillin skin testing.

Eligibility Criteria:
Inclusion Criteria:patients with a history of non-life threatening allergic reaction to penicillin, dating back at least 3 years -

Exclusion Criteria:Patients who had a life-threatening anaphylactic reaction to penicillin consisting of unconsciousness or anaphylaxis requiring life-resuscitation and those who had non-IgE mediated hypersensitivity reactions

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High-dose Chemotherapy and Stem Cell Transplantation for Central Nervous System (CNS) Relapse of Aggressive Lymphomas

Central nervous system (CNS) relapses of aggressive lymphomas are a rare but devastating complication. There is no therapy standard, conventional approaches are palliative. This study investigates an intensive chemotherapy with CNS penetrating drugs followed by high-dose chemotherapy and autologous stem cell transplantation as a potentially curative approach.


Eligibility Criteria:
Inclusion Criteria:

* highly-malignant non-Hodgkins-Lymphoma, mantle-cell lymphoma or follicular lymphoma 3°
* CNS relapse (meningeal or/and intraparenchymal) with or without systemic lymphoma manifestations
* ECOG performance score ≤2
* no active infection
* negative HIV-serology
* adequate renal function (creatinine clearance \> 50 ml/min)
* adequate bone marrow function (granulocytes \>1500/μl, platelets \> 80000/μl)
* normal bilirubin, AST \< 3 x UNL
* negative pregnancy test

Exclusion Criteria:

* newly diagnosed NHL with primary CNS involvement
* indolent NHL, lymphoblastic NHL or Burkitt lymphoma
* preceding CNS irradiation
* pretreatment of CNS relapse other than corticosteroids
* immunosuppression, concomitant immunosuppressive therapy, status after organ transplantation or allogenous stem cell transplantation
* second cancer other than basalioma or cervical carcinoma in situ within the last 5 years
* unfit to receive an intensive chemotherapy
* pregnancy or breastfeeding
* known intolerance to MTX, ifosfamide, Depocyte, cytarabine, thiotepa, carmustine or etoposide
Depressive Symptoms and Emotion Regulation Following Cognitive Behavioral Therapy

This study investigates depressive symptoms and the use of emotion regulation strategies over the course of a two-year period in participants terminating outpatient cognitive behavioral therapy for depression. The main objective of the study is to examine if changes in the use of certain emotion regulation strategies (e.g. reappraisal, rumination) predict depression relapse or changes in depressive symptoms after the completion of outpatient cognitive behavioral therapy.


Eligibility Criteria:
Inclusion Criteria:

* age older than 18 years
* regular termination of outpatient cognitive behavioral therapy for depression (or premature termination agreed upon by both the therapist and the patient because of symptom improvement after at least 12 sessions)
* last therapy session not more than two weeks prior to enrollment
* self-reported improvement in depressive symptoms as a result of cognitive behavioral therapy
* possession of a smartphone (operating system: Android or iOS) with Internet access
* possession of a laptop/desktop computer with Internet access
* familiarity with apps and the Internet
* fluency in German language

Exclusion Criteria:

* premature termination of outpatient cognitive behavioral therapy (exception: termination agreed upon by both the therapist and the patient because of symptom improvement)
* BDI-II score ≥ 20
* acute substance use disorder (\< 3 months)
* current or past psychotic disorder
* current or past (hypo)manic episode
* acute suicidality
* severe neurological disorder/cerebral damage
* severe physical/medical illness