cyrilzakka/clinical-trials huggingface dataset:
Study of Abiraterone Acetate in Subjects With Metastatic Castration Resistant Prostate Cancer

Abiraterone acetate is an orally effective CYP17 inhibitor, which is metabolized into abiraterone in the body, and its inhibitory activity against CYP17 is 10-30 times that of ketoconazole. Clinical studies have shown that abiraterone acetate can significantly reduce the level of prostate specific antigen (PSA) in PCa patients, and help to reduce tumors, extending the lifespan of patients with advanced PCa for several years, and the toxicity is acceptable.


Eligibility Criteria:
Inclusion Criteria:

- 1.18 years and older, Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, Life expectancy ≥ 6 months.

2. Prostate cancer. 3. Serum testosterone \<50 ng/dL (or 1.7 nmol/L). 4. Prostate cancer progression or lesion metastasis. 5. Restriction of antiandrogen therapy. 6. Restriction of Radiation therapy. 7. The treatment period of ketoconazole for prostate cancer was not exceed 7 days.

8. Has not used opioid analgesics and azole drugs within 4 weeks before the first dose.

9. Question 3 of the Concise Pain Questionnaire (BPI-SF) scored from 0-3 points.

10. Adequate laboratory indicators. 11. Must be able to swallow tablets. 12. No pregnant or breastfeeding women, and a negative pregnancy test. 13. Understood and signed an informed consent form.

Exclusion Criteria:

1. Prostate pathology results are neuroendocrine prostate cancer.
2. Has received cytotoxic chemotherapy or biological therapy for metastatic castration resistant prostate cancer.
3. Has contraindications to the use of prednisone.
4. A chronic disease that exceeds the prednisone dose in the study.
5. Uncontrolled high blood pressure.
6. Active or symptomatic viral hepatitis or other chronic liver disease.
7. Visceral metastasis or brain metastasis.
8. Pituitary or adrenal dysfunction.
9. Active autoimmune diseases require the use of hormone therapy.
10. Clinically significant heart disease.
11. Participated in other clinical trials within 4 weeks.
Impact of Implantation of an LAA Occluder on ANP and BNP Level and Quality of Life

Closure of the LAA by several devices is a alternative therapy to oral anticoagulation in patients with Atrail fibrillation. Nothing is known about the acute influence of a device closure of the LAA on the secretion of ANB nad BNP hormones. Therefore aim of our study is to measure ANB and BNP levvels before and after Implantation of an LAA closure device.

ANB and BNP levels are measured before, directly after and late after 24 h in central or periphereal venous blood from patients undergoing interventional LAA closure.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing LAA closure

Exclusion Criteria:

* none
Paclitaxel Polymeric Micelles and Carboplatin in Combination With Iparomilimab and Tuvonralimab Neoadjuvant Therapy for Triple-negative Breast Cancer

This is a prospective, single-arm, multicenter study to observe and evaluate the efficacy and safety of paclitaxel polymeric micelles and carboplatin in combination with iparomilimab and tuvonralimab in neoadjuvant therapy for triple-negative breast cancer. The main endpoint of the study is pCR, 32 patients are scheduled to be enrolled.


Eligibility Criteria:
Inclusion Criteria:

* Triple-negative breast cancer
* The diameter of the primary tumor must be greater than 2cm, and the clinical stage should be II-III
* There is sufficient primary organ function
* The ECOG (PS) score is 0 or 1
* Expected survival ≥ 6 months
* The serum pregnancy test was negative. Use highly effective methods of contraception during the study period and for 180 days after the last dose of the study drug, and do not breastfeed

Exclusion Criteria:

* Bilateral breast cancer
* There is a history of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS)
* A history of invasive or metastatic breast cancer
* Any malignancy diagnosed within 5 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma, or squamous cell carcinoma
* There is an immune deficiency disease
* The presence of any autoimmune disease that still requires treatment or a history of prior autoimmune disease
Effects of a Ketoacid Supplementation in Patients With Stage III to IV Renal Failure

The aim of the study is to demonstrate that a ketoacid supplement in patients with stage III to IV chronic renal failure, reduces the excretion of urinary urea nitrogen

Patients with an estimated glomerular filtration rate of less than 25 ml/kg/min, not on renal substitution therapy, without important concomitant diseases and aged between 40 and 70 years, will be invited to participate in the study. They will be randomly assigned to a group that will receive receive a supplement of ketoacids (Ketosteril) 1 tablet containing 630 mg of ketoacids every 5 kg of body weight and a diet containing 25 to 35 kcal/kg and 0.3 g/protein per day or to a group receiving placebo and a diet containing 25 to 35 kcal/kg and 0.6 g/protein per day. The intervention will last 16 weeks. At baseline and the end of the intervention a blood sample will be obtained to measure creatinine, urea nitrogen and cystatin C. Also a spot urine sample will be obtained to measure urea nitrogen and creatinine excretion. The compliance with the dietary prescription and the ketoacid or placebo supplement will be assessed every 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Estimated glomerular filtration rate of less tan 25/ml/min/1.73m2
* Not on renal substitution therapy
* Absence of severe life threatening concomitant diseases

Exclusion Criteria:

* Malignant or renovascular hypertension
* Use of systemic steroids or immunosuppressant drugs
* Alcohol or illicit drug abuse
* A body mass index of less tan 18 kg/m2
Real World Efficiency of Trastuzumab in Early Breast Cancer

AIM To determine the value of trastuzumab in the early breast cancer setting in the Netherlands.

RESEARCH QUESTIONS / OBJECTIVES

1. Is adjuvant trastuzumab in daily practice effectively used, that is, how and to whom is it given?
2. Is the introduction of trastuzumab in early breast cancer cost-effective for the Netherlands?

To address the research questions (objectives), the following outcome measures will be determined:

CLINICAL OUTCOME MEASURES

1. Actual trastuzumab administration as opposed to planned trastuzumab administration
2. Selection criteria for chemotherapy and trastuzumab in daily practice
3. Immediate and longterm toxicities due to adjuvant treatment, specifically cardiac
4. Disease-free, breast cancer specific, and overall survival in relation to trastuzumab

   ECONOMIC OUTCOME MEASURES
5. Volumes and costs of diagnostic tests and therapies including those for (distant) relapse
6. Cost-effectiveness of trastuzumab in clinical trials versus in real world


Eligibility Criteria:
Inclusion Criteria:

* All patients diagnosed with invasive stage I-III breast cancer in the years 2005, 2006 and 2007 in the participating 5 hospitals.

Exclusion Criteria:

* Distant metastasis at the time of the primary diagnosis
Effect of Participation in Virtual Exercise Sessions in Persons With Aphasia

The purpose of this study is to test the feasibility and acceptability of an online exercise program for community-dwelling individuals with aphasia, a language disorder resulting from brain damage. Physical activity, language, cognitive, and quality of life outcomes will be collected to assess potential effectiveness.

Approximately one-third of stroke survivors have aphasia, acquired language difficulty that affects the ability speak and understand others. However, despite documented benefits of interventions to promote physical activity (PA) after stroke, including improved health-related quality of life (QoL), social and emotional benefits, and improved cognition, individuals with aphasia are often excluded from this research due to their communication difficulties. This is particularly concerning, given that individuals with aphasia are at greater risk of social isolation and depression compared to stroke survivors without aphasia. Presently, limited research has been conducted that examines the effect of PA interventions in individuals with aphasia although preliminary findings suggest that benefits may exist across domains (health and disability).

This study aims to better understand how PA affects the lives of individuals with aphasia. Given weekly tele-instruction in PA over 10 weeks, participants' levels of PA will be monitored for the duration of the study. Pre- and post-treatment measures of cognitive ability, QoL, and aphasia severity will be collected and analyzed to characterize intervention effects. The results of this study will provide insight into whether PA may be an important component of future aphasia treatment.

Eligibility Criteria:
Inclusion Criteria:

* Presence of aphasia
* Able to join exercise classes over Zoom

Exclusion Criteria:

* None
Gemcitabine and Docetaxel Therapy in High-risk BCG-naive Patients With Non-muscle Invasive Bladder Cancer

Bacillus Calmette-Guerin (BCG) is the standard of care for high-risk patients with non-muscle invasive bladder cancer (NMIBC) after transurethral tumor resection. Since 2012, global BCG shortage encouraged the search of alternative treatment for NMIBC treatment. Intravesical gemcitabine and docetaxel chemotherapy (GEM/DOCE) has shown safety and efficacy in 2 retrospective, single institution cohorts. At our institution, GEM/DOCE has been offered as an option for NMIBC in the treatment of high-risk BCG-naive patients per the protocol adapted from University of Iowa, in shortage situation. Our objective is to evaluate the efficacy of GEM/DOCE therapy.


Eligibility Criteria:
Inclusion Criteria:

* BCG-naive patients with high-risk non-muscle invasive bladder cancer

Exclusion Criteria:

* patients in whome cystectomy is planned
Post Operative RT for Limited Spine Metastases

To evaluate patients with limited spine metastases treated with total spondylectomy followed by conventional radiotherapy or debulking surgery followed by SBRT or conventional RT. The study primary endpoint is one year local control.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who had pathologically proved solid cancer, with radiographic evident limited spine metastases indicative and feasible for spondylectomy or debulking surgery.
2. Patients with maximum two continuous level of spine metastases need for surgery are eligible. Patients who have other spine metastases but not necessary for surgery are allowed.
3. A preoperative gadolinium enhance MRI should be obtained up to 8 weeks before enrollment.
4. Patients aged at least 20 years old are eligible.
5. Life expectancy of ≥ 6 months.
6. ECOG performance status 0-2 (ECOG 3-4 related to cord compression can be enrolled after physician assessment)
7. No prior RT to the index spine level(s)
8. Women of childbearing potential must practice adequate contraception
9. Patients must be able to comply with the study protocol and follow-up schedules and provide study-specific informed consent.

Exclusion Criteria:

1. Patients received prior radiotherapy to the index spine level.
2. Patients who cannot receive Gadolinium enhanced MRI due to pacemaker or metal implant or who cannot receive contrast enhanced CT scan due to impaired renal function.
3. Patients who have hematological cancer or primary spine tumor will be excluded for enrolment.
4. Patients who cannot tolerate radiotherapy immobilization.
5. Severe, active comorbidities which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and adverse events of the protocol, or limit compliance with study requirements, defined as follows:

   1. Uncontrolled active infection requiring intravenous antibiotics at the time of registration
   2. Transmural myocardial infarction ≤ 6 months prior to registration.
   3. Life-threatening uncontrolled clinically significant cardiac arrhythmias.
   4. Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects.
   5. Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration.
   6. Uncontrolled psychiatric disorder.
6. Pregnant or breast-feeding women
Biosimilarity Study of Intravenous Recombinant Human Erythropoietin in Healthy Volunteers

Open label and monocentric Phase I Clinical Trial, to Determine the Pharmacokinetics and Pharmacodynamics of Recombinant Human Erythropoietin for Subcutaneous Use in an Adult Male Population

An open label, balanced, randomized, two treatments, two sequences, two periods, single dose, crossover design will be used to study the pharmacokinetics and pharmacodynamics of two different rHuEpo products when administered subcutaneously in healthy subjects.

PK parameters to evaluate shall be AUCt and AUCt to infinity, and Cmax PD parameter shall be erithrocye and reticulocyte counts and hematocrite. Bioequivalence shall be evaluated according to 80-125 T/R rate for 90 % Cmax and AUC for pk and PD parameters.

Eligibility Criteria:
Inclusion Criteria:

* Healthy eligible participants able to read, understand and sign the latest version of the Informed Consent Form (FICF) approved by the Research Ethics Committee (CEP);
* Male participants aged between 18 and 55 years;
* Be characterized as a healthy research participant, based on medical history, general physical examination and vital signs, laboratory tests and ECG not indicating any evidence of disease;
* Present BMI ≥ 18 and ≤ 29.9 Kg/m2;
* Have a body weight of 60 - 100 kg;
* Present a negative test for coronavirus.

Exclusion Criteria:

* Present one or more flu-like symptoms such as: fever (body temperature greater than or equal to 37.8°C), cough, dyspnea, myalgia and fatigue, respiratory symptoms, gastrointestinal symptoms (such as diarrhea) within 7 days prior to the hospital stay (all periods);
* Having had direct and significant contact, at the medical discretion, with people who tested positive for a coronavirus test within 14 days prior to the hospital stay (all periods);
* Living in the same household as people who fall into the risk group of worse prognosis for coronavirus infection, such as individuals over 60 years old, individuals with respiratory problems, immunosuppressed or those with chronic diseases such as heart or diabetes (all periods );
* Any clinical condition or laboratory alteration that, at the investigator's discretion, may compromise trial participation, ie:
* Have an abnormal erythrocyte count (\<4.0 M/mm3 or \>5.4 M/mm3);
* Have an abnormal reticulocyte count (\> 3.0%);
* Have an abnormal platelet count (\< 135,000/μL or \> 550,000/μL);
* Have an abnormal hemoglobin level (\< 13g/dL);
* Have an abnormal level of hematocrit (\<40% or \>54%);
* Have an abnormal level of ferritin (\< 100 ng/mL or \> 336.2 ng/mL);
* Have an abnormal level of transferrin (\< 200 mg/dL or \> 360 mg/dL);
* Have an abnormal level of transferrin saturation (\<20%)
* Have abnormal levels of vitamin B12 (\< 130 pg/mL or \>868 pg/mL);
* Present evidence of cardiovascular disorders, particularly arterial hypertension (supine blood pressure \> 145 / 90mmHg at baseline);
* History of venous thrombosis;
* Participants diagnosed with iron deficiency anemia or clinical history of autoimmune or hereditary anemia;
* Clinical history of chronic or acute hemorrhages in the 30 days preceding the start of the trial;
The Effect of Exercise and Presleep Nutrition on Muscle Connective Tissue Remodelling

The primary objective of this study will be to determine the influence of a presleep vitamin C-enriched, collagen-modelled supplement (CVC) on the metabolic fate of dietary glycine using a \[2H5\]glycine tracer within the intramuscular connective tissue at rest and after a bout of resistance exercise. Other outcomes will be related to regulation collagen remodelling in skeletal muscle.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, recreationally active, male and female participants.
* Healthy will be defined as someone who does not have a health condition that would compromise their ability to safely participate in the strenuous physical activity involved in our study as screened for by the Get Active Questionnaire.
* Willing to abstain from resistance exercise for 2 weeks prior to the first metabolic trial and for the duration of the study.
* Participants must be able to abstain from lower-body resistance and/or plyometric exercise for at least 2 weeks prior to the first metabolic trial.
* Participants will be aged 18-35 years old.
* Participants must be normal to overweight (e.g., BMI 18.5-30).
* Participants are willing to abide by the compliance rules of this study (e.g., abstain from physical activity and alcohol 48h prior to each trial).
* Self-reported regular menstrual cycle (25-35d) within the last 3 months (female participants).

Exclusion Criteria:

* Inability to adhere to any of the compliance rules judged by principal investigator or medical doctor.
* Self-reported regular tobacco use.
* Self-reported illicit drug use (e.g. growth hormone, testosterone, etc.).
* Regular use of anti-inflammatory drugs (e.g., ibuprofen).
* Self-reported regularly sleeping less than an average of 7 hours over 3 days (minimum recommended daily amount).
* Individuals who have participated in studies within the past year involving any of the stable isotopes in the study.
* Use of birth control and discontinued use in the last 3-months (female only).
Low-dose Temozolomide for 2 Weeks on Brain Tumor Enzyme in Patients With Gliomas (P04602 AM1) (Completed)

The main purpose of this study is to assess the effect of a two-week pre-surgery treatment with low-dose temozolomide (TMZ) on brain tumor methylguanine-DNA (deoxyribonucleic acid) methyltransferase (MGMT) activity in patients with gliomas.


Eligibility Criteria:
Inclusion Criteria:

* Presence of a brain tumor with high probability of being a glioma as detected by Magnetic Resonance Imaging (MRI). These would include newly diagnosed tumors or potentially recurrent gliomas.
* No prior treatment for the tumor including chemotherapy or radiotherapy.
* Amenable to surgery for biopsy or resection of the brain tumor. Surgically confirmed diagnosis of glioma (glioblastoma multiforme \[GBM\], anaplastic astrocytoma \[AA\], anaplastic oligodendroglioma \[AO\], anaplastic oligoastrocytoma \[AOA\], astrocytoma \[A\] or oligodendroglioma \[O\]) will be

required for patients to be maintained in the study. Those not fulfilling this requirement will be discontinued and will be replaced.

* Use of medically approved contraception in fertile males and females.
* Women with childbearing potential must have a negative urine or serum

pregnancy test (urinary excretion or serum level of beta-Human Chorionic

Gonadotropin \[bHCG\]) within 72 hours of randomization.

* Karnofsky Performance Status score \>= 70%.
* Signed informed consent form

Exclusion Criteria:

* Prior chemotherapy.
* Prior radiotherapy at the tumor site.
* History of non-compliance to other therapies.
* Inadequate haematological, renal and hepatic function according to all of the following laboratory values (to be performed within 14 days, inclusive, prior to study inclusion):

  * Absolute neutrophil count ≤1.5 x 10\^9/L;
  * Platelets ≤100 x 10\^9/L;
  * Haemoglobin \<90 g/L;
  * Serum creatinine ≥1.5 times upper limit of laboratory normal;
  * Total serum bilirubin ≥1.5 times upper limit of laboratory normal (ULN);
  * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2.0 ULN;
  * Alkaline phosphatase of \> 2.5 ULN.
* Known Human Immunodeficiency Virus \[HIV\] infection.
* Known chronic hepatitis B or hepatitis C infection.
* Any other serious medical condition according to the medical judgment of the physician prior to inclusion in the study.
* Any medical condition, which could interfere with oral medication intake (e.g., frequent vomiting, partial bowel obstruction).
Comparison of Self-administered IPSS, Sanitary Staff-supervised IPSS, Medical History and Clinical Parameters

Descriptive prospective study carried out to compare the results obtained by self-administered IPSS (International Prostate Symptom Score), Sanitary staff-supervised IPSS and directed medical interview and its correlation with clinical parameters in the assessment of lower urinary tract symptoms in males.

The IPSS is a validated questionnaire (also in spanish language) widely used to evaluate lower urinary tract symptoms (LUTS) in males. It contains 7 multiple-choice questions related to urinary symptoms with a Likert response scale and 1 question assessing quality of life. This test has been approved for self-administration and its purpose is quantifying and monitoring symptoms severity.

The aim of this study is to compare the scores achieved in a self-administered IPSS questionnaire with those obtained when the questionnaire is answered with the help and supervision of a sanitary staff. These results will also be contrasted with the scores retrieved in a standard directed medical interview and correlated with objective functional parameters of lower urinary tract symptoms.

A descriptive prospective study will be carried out analysing lower urinary tract symptoms from patients over 50 years old.

All patients will be provided with a IPSS to be fulfilled at home and after a short period of time without any change in his LUTS treatment, the patient will repeat the questionnaire in the hospital under the supervision of a sanitary staff.

A standard structured medical interview focusing in LUTS will be performed to every patient. In order to compare the results achieved with both IPSS with those obtained during the interview a Likert score was assigned to each question.

At the same time, objective lower urinary tract symptoms data will be collected and compared to the results obtained previously with both the questionnaires and the medical interview. Uroflowmetry and post physiological void residual volume measurement with ultrasonography will be performed as evaluation of voiding symptoms. On the other hand, filling symptoms will be evaluated with a validated 3-day voiding diary to be accomplished previously to the medical visit.

Data to be collected includes Uroflowmetry parameters Qmax, Qm, curve shape type and time to Qmax, ultrasonographic PVR (post-void residual) measurement and daytime and nightime number of voids, medium volume of void, number of urgency and urge incontinence episodes and maximal vesical functional volume wich will be extracted from the 3-day voiding diary.

A statistical analysis will be performed to compare the scores obtained through the questionnaires and the medical interview and the correlation of each of them with the objective clinical parameters obtained.

Eligibility Criteria:
Inclusion Criteria:

* males older than 50 years, with LUTS

Exclusion Criteria:

* Urinary tract infection
* Bladder tumor o lithiasis
* changes in LUTS treatment during the analysis period (pharmacological or surgical)
* urethral manipulation during the analysis period (catheterization or cystoscopy)