cyrilzakka/clinical-trials huggingface dataset:
Lycopene in Healthy Male Participants

This randomized phase I trial is studying the side effects and best dose of lycopene in healthy male participants. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of lycopene, a substance found in tomatoes, may prevent prostate cancer.

OBJECTIVES:

I. Compare the toxicity and safety of 2 different doses of oral lycopene in healthy male participants.

II. Compare the pharmacokinetics of 2 different doses of this drug in these participants.

III. Determine the toxicity and pharmacokinetics needed to proceed to a large phase II/III study in men at high risk for prostate cancer.

OUTLINE: This is a randomized, crossover study. Participants are randomized to 1 of 2 treatment arms.

Arm I: Participants receive high-dose oral lycopene once or twice a day for 14 days. After 2 weeks of a lycopene-free period, participants crossover and receive high-dose lycopene at the alternative daily schedule (once or twice a day) for 14 days.

Arm II: Participants receive low-dose oral lycopene once or twice a day for 14 days. After 2 weeks of a lycopene-free period, participants crossover and receive low-dose lycopene at the alternative daily schedule (once or twice a day) for 14 days.

Treatment continues in the absence of unacceptable toxicity. Participants adhere to dietary restrictions for 2 weeks at baseline, 2 weeks during study treatment, and 2 weeks during pharmacokinetic sampling.

Blood samples are collected periodically at baseline and during study treatment for pharmacokinetic studies.

PROJECTED ACCRUAL: A total of 20 participants will be accrued for this study.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers judged to be in good medical condition based on history and physical exam
* Karnofsky performance status 100%
* AST and ALT ≤ 75 IU/L
* Bilirubin ≤ 2.0 mg/dL
* Creatinine ≤ 1.5 mg/dL
* Hemoglobin ≥ 13.0 g/dL
* WBC ≥ 4,000/mm³
* Platelet count ≥ 150,000/mm³ and ≤ 400,000/mm³
* Must be within height and weight standards identified by Metropolitan Life scales
* Nonsmoker (for ≥ 3 months)
* No history of alcohol abuse
* No history of gastrointestinal malabsorption or other condition that could affect drug absorption
* No history of a psychiatric condition
* No chronic medical condition
* No active history of any of the following:

  * Cancer
  * Liver disease
  * Cardiovascular disease
  * Renal disease
  * Diabetes mellitus
  * Other illnesses that, in the opinion of the investigator, could represent a threat for the participants life
* No allergy to tomato-based products
* No lycopene in the diet for ≥ 14 days
* At least 4 weeks since prior and no other concurrent experimental medications
* No concurrent participation in another experimental study
* No concurrent use of regular prescription medication or over-the-counter medications
* No concurrent vitamin, mineral, or herbal supplements
Cerebral Lesion and Neurocognitive Status Changes After TAVR

The CLEVER-TAVR cohort (Cerebral Lesion and Neurocognitive Status Changes after Transcatheter Aortic Valve Replacement) is a multicenter observational cohort study. The investigators will screen consecutive patients ≥65 years of age before TAVR and enroll those that complete the procedure successfully. The investigators will assess the neurocognitive function using multiple tests with Reliable Change Index before TAVR and 7, 30, 90, 180 and 360 days after TAVR. The primary endpoint will be major adverse cardiovascular and cerebral events(MACCE, defined according to the Valve Academic Research Consortium-2 data dictionary) at 1 year.

Study Design The CLEVER-TAVR cohort (Cerebral Lesion and Neurocognitive Status Changes after Transcatheter Aortic Valve Replacement) is a multicenter prospective observational study. Patients with aortic stenosis who successfully undergo TAVR procedure from January 2021 to December 2021 will be enrolled in this study according to the inclusion criteria. Preoperative cognitive function, DW-MRI evaluation and baseline data will be recorded. All patients should be followed up for 1 year, including telephone follow-up once a month to record the main end-point events, and clinic follow-up at 30, 90, 180, 360 days after TAVR. Laboratory examination, electrocardiogram, color Doppler ultrasound and other examinations will be collected and recorded. The changes of cognitive function and brain imaging (DW-MRI) will be evaluated before discharge(7 days), 30, 90, 180, 360 days after procedure. The primary endpoint will be major adverse cardiovascular and cerebral events(MACCE), including all-cause death, stroke, acute kidney injury, myocardial infarction, bleeding complications, vascular complications, permanent pacemaker implantation, conduction block and arrhythmia, valve related complications. The postoperative valve function, life quality and other complications related to TAVR will also be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Patients voluntarily participated and signed informed consent;

  * Patients with severe aortic stenosis undergo TAVR after assessment by the Heart Team; \[Definition of severe aortic stenosis: mean aortic pressure gradient (MPG) ≥ 40 mmHg, aortic valve area (AVA) ≤ 1.0 cm2 and maximal aortic velocity (Vmax) ≥ 4 m / s.\] ③ Age ≥ 65 years old.

Exclusion Criteria:

* Emergency procedure;

  * Severe cognitive impairment (MMSE \< 15), or years of education \< 6 years;

    * Unstable condition (intractable angina pectoris, acute heart failure) or patients can not complete MRI examination or cognitive assessment;

      * TAVR operation failed or transferred to surgery for SAVR due to serious complications; ⑤ Speech disorders, or mental disorders, or severe physical disorders (MRS ≥ 3); ⑥ Patients with complicated congenital heart disease, HCM, surgery valve replacement or combined valvular disease; ⑦ Patients with life expectancy less than 12 months.
umBilical Or Adult Donor Red Blood Cells in Extremely Low Gestational Age Neonates and Retinopathy of Prematurity (BORN)

Extremely low gestational age neonates (ELGAN, i.e., born before 28 gestation weeks) are among the most heavily transfused pediatric patients. In this clinical setting, repeated red blood cell (RBC) transfusions independently predict a poor outcome, with a higher risk for mortality and morbidity. Recent studies from our own and other groups highlighted a close association between low levels of fetal hemoglobin (HbF) and severity of retinopathy of prematurity (ROP) and bronchopulmonary dysplasia (BPD), two disabilities that frequently complicate preterm birth. This association is not surprising, considering that 1) preterm neonates have a highly immature antioxidant reserve and both ROP and BPD rely on the oxidative damage as underlying mechanism; 2) in comparison with HbA, HbF is endowed with higher oxygen affinity, greater redox potential, higher tetrameric stability, and higher ability to generate unbound nitric oxide, all functions potentially protective in presence of an oxidative challenge; 3) in normal prenatal life, developing organ and tissues are exposed exclusively to HbF until last weeks of gestation; 4) in preterm neonates, the switch of the synthesis from HbF to HbA occurs around their due date, i.e., several weeks after the premature birth; 5) when preterm neonates receive transfusions, their tissues are abruptly exposed to high levels of HbA. We have recently run a pilot trial demonstrating as a proof-of-concept that transfusing cord blood red blood cell concentrates (CB-RBC) effectively prevents or restrains the HbF loss consequent to adult donor standard transfusions (A-RBC). This study explores the hypothesis that transfusing CB-RBCs instead of A-RBC may lower the incidence of severe ROP in ELGANs needing transfusions.


Eligibility Criteria:
Inclusion Criteria:

* gestational age (GA) at birth between 24+0 and 27+6 weeks
* signed informed consent of parents.

Exclusion Criteria:

One or more of the following:

* maternal-fetal immunization
* hydrops fetalis
* major congenital malformations associated or not with genetic syndromes
* previous transfusions
* hemorrhage at birth
* congenital infections
* health care team deeming it inappropriate to approach the infant's family for informed consent.
Comparison of Two Interdental Devices for Peri-Implant Plaque Control

This randomized clinical trial aims to compare the efficacy of two interproximal cleaning devices-superfloss and interdental brushes- in patients diagnosed with peri-implant diseases. The study evaluates plaque control and bleeding scores. Patients will be randomly assigned to one of two oral hygiene protocols and will be monitored through clinical examinations and validated questionnaires assessing both clinical and radiographic parameters and patient-reported outcomes.

This single-center, randomized, parallel-arm clinical trial aims to compare the efficacy of superfloss and interdental brushes, used in combination with an electronic toothbrush, in patients with peri-implant diseases. Participants will be randomly assigned to one of two oral hygiene protocols. Clinical assessments will be performed at baseline, 6 weeks, and 3 months, including plaque index, bleeding scores, and probing depth. Radiographic measurements and standardized patient-reported questionnaires (food impaction and oral hygiene self-efficacy) will also be used. The primary outcome is the reduction of plaque and gingival inflammatory scores at implant sites.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 70 years
* Presence of at least one implant loaded for ≥1 year
* Presence of bleeding (≥1 site or line/profuse bleeding) and/or suppuration on gentle probing around the implant
* Systemically healthy adults
* Able to provide written informed consent

Exclusion Criteria:

* Use of anticoagulants, anti-aggregants, antibiotics, or corticosteroids in the past 3 months
* Pregnant or lactating women
* Inability to perform adequate oral hygiene
Efficacy of the Consumption of a Spinach Extract on Muscle Function in Subjects Over 50 Years of Age

Controlled, randomized, single-center, double-blind clinical trial, with two parallel branches depending on the product consumed, to measure the efficacy of a supplement extracted from spinach on muscle strength in subjects over 50 years of age.

Subjects who meet the selection criteria will make two visits to the laboratory to perform the tests established in the protocol. In addition, all subjects will develop a program of strength, polyarticular, individualized and progressive exercises in which the main muscle groups are worked. The program will be held three days a week (36 sessions). Subsequently, a statistical analysis will be performed with the variables measured in the study to obtain results.

Eligibility Criteria:
Inclusion Criteria:

* Age between 50 and 75 years.
* Body mass index less than 32.
* Subjects who do not develop physical exercise scheduled on a weekly basis.
* Subjects who have given written informed consent to participate in the study.

Exclusion Criteria:

* Consumption during the 6 months prior to the study of functional food or supplement that modifies body composition.
* Presence of absolute or relative contraindications dictated by the American College of Sports Medicine, for the performance of physical exercise.
* Presence of chronic diseases that prevent the performance of a physical exercise program (disabling arthropathies, moderate / severe chronic lung disease, ischemic heart disease under treatment, arrhythmias, etc.).
* Abuse in the ingestion of alcohol.
* Present hypersensitivity or intolerance to any of the components of the products under study.
* Inability to understand informed consent.
* Serious or terminal illnesses.
* Subjects with a body mass index above 32.
* Pregnant or lactating women.
* Inability to understand informed consent.
Recanalization Rate of Acute DVT

Rporting and evaluation of the rate of recanalization of acute DVT of the lower limb at one year follow-up comparing the results of using NOACs vs. conventional treatment.

Deep vein thrombosis (DVT) is an important cause of disability and mortality in our society . The incidence of DVT significantly increases with age, being more prevalent in women than men . The location of DVT is also an important factor to be studied because of its association with pulmonary embolism and development of post-thrombotic syndrome (PTS) , Currently, duplex ultrasound scanning (DUS) is the method of choice for diagnosis of DVT because it is non-invasive, provides real-time imaging, and has high sensitivity and specificity especially for detection of proximal DVT .

The new oral anticoagulants (NOACs), are poised to replace warfarin for treatment of the majority of patients with venous thromboembolism (VTE), With a rapid onset of action and the capacity to be administered in fixed doses without routine coagulation monitoring, NOACs have been shown to be noninferior to conventional anticoagulant therapy for prevention of recurrence with less bleeding.

Most studies have reported that more advantages than disadvantages for NOACs when compared with VKAs, with the most important advantages of NOACs including safety issues (ie, a lower incidence of major bleeding), convenience of use, minor drug and food interactions, a wide therapeutic window, and no need for laboratory monitoring. Nonetheless, there are some conditions for which VKAs remain the drug of choice.

Eligibility Criteria:
Inclusion Criteria:

* • Patients suffering from first attack of acute DVT (De novo) of the lower limb who (only femoral-popliteal type) aged 18 - 80 years.

Exclusion Criteria:

* Patients suffering from recurrent DVT.
* Patients with acute DVT candidate for CDT (limb threatening acute DVT).
* Patients suffering from acute DVT with malignancy.
* Pregnant and Lactating females.
* Patients with severe renal Impairment (CrCl \<30mL/min), Severe hepatic impairment.
Study Of SU011248 In Combination With Docetaxel (Taxotere) And Prednisone In Patients With Prostate Cancer

This is a multi-center, open-label, Phase 1/2 study of SU011248 (sunitinib malate, SUTENT) in combination with docetaxel and prednisone for the first-line treatment of metastatic hormone-refractory prostate cancer (mHRPC).


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of the prostate
* Patients must have progressive hormone-refractory prostate cancer (HRPC): patients must have undergone primary hormone treatment (e.g. orchiectomy or gonadotropin releasing hormone analog with or without antiandrogens). For patients who received antiandrogen therapy, disease progression must have been determined after antiandrogen discontinuation
* Progressive disease based on either non-measurable disease and an elevated PSA OR measurable disease
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion Criteria:

* Prior thalidomide, anti-vascular endothelial growth factor (VEGF) therapy, VEGF receptor inhibitor, platelet-derived growth factor (PDGF) receptor inhibitor or anti-angiogenic treatment of any kind including investigational therapy
* Prior chemotherapy
* Uncontrolled pain at baseline, impending complication from bone metastasis (fracture and/or compression) and/or presence of urinary obstruction (urinary retention, hydronephrosis)
* History of cardiac dysfunction, QT interval corrected for heart rate (QTc) \>450 msec
* Central Nervous System (CNS) involvement
Daily REmote Ischaemic Conditioning Following Acute Myocardial Infarction

Remote ischaemic conditioning (RIC) is known to reduce infarct size post MI when used in the peri/immediate post infarct period. However little is known as to the effect of repeated remote conditioning post-MI (Myocardial Infarction) on not only infarct size, but also on ventricular remodeling and ultimately cardiac failure. In this phase II first in man trial, the investigators intend to carry out daily remote ischaemic conditioning in post MI patients. The principal hypothesis is that RIC applied on a daily basis for 4 weeks following a heart attack improves the ejection fraction at 4 months as assessed by cardiac magnetic resonance imaging.


Eligibility Criteria:
Inclusion Criteria:

* LVEF \< 45% on baseline ECHO
* First STEMI
* Successful revascularisation by PPCI
* Able to attend regional centre for follow-up appointment
* Competent to consent

Exclusion Criteria:

* \< 18 of age
* ICD or CRTP/D in-situ
* Prior history of heart failure
* Haemoglobin \< 11.5 g/dl
* Creatinine \> 200 µmol/L (eGFR\<30ml/min/m2)
* Known malignancy/other comorbid condition which in the opinion of the investigator is likely to have significant negative influence on life expectancy
* Significant complications/illness following MI
* Unable to undergo cMRI
* Further planned coronary interventions
* Enrollment in another clinical trial
Randomized Controlled Phase II Trial of Pre-operative Celecoxib Treatment in Breast Cancer

Cyclooxygenase-2 (COX-2) is frequently over-expressed in primary breast cancer. There is evidence that COX-2 inhibition exerts anti-tumor effects in breast cancer. To further determine the effect of COX-2 inhibition in primary breast cancer, we aimed at studying the changes in breast cancer tissues of patients treated with the selective COX-2 inhibitor celecoxib.

In a single-centre double-blinded phase II study, breast cancer patients were randomised to receive either pre-operative celecoxib (400 mg) or placebo twice daily for two to three weeks. We collected fresh-frozen pre-surgical biopsies (before treatment) and surgical excision specimens (after treatment) to assess the tumor changes by use a cDNA microarray, which allows to study the genome-wide changes at the transcriptional level.


Eligibility Criteria:
Inclusion Criteria:

* Female patients suspected of having invasive breast cancer, \>1 cm in diameter, and in whom there is an indication for a core or incision biopsy
* Age \<75 years at time of diagnosis
* Patient willing and able to comply with the study prescriptions
* Patient able to give written informed consent before patient registration/randomisation
* Pre- and post-menopausal patients are eligible
* Hormone receptor positive and negative patients are eligible
* A negative pregnancy test in pre-menopausal women

Exclusion Criteria:

* HIV, HBV or HCV positivity
* Known hypersensitivity to NSAIDs
* A history of upper gastro-intestinal bleeding
* Endoscopically proven upper gastro-intestinal ulceration
* Patients using NSAIDs, including salicyclic acid
* Systemic use of corticosteroids
* A history or the presence of any other malignancy excepting adequately treated squamous cell skin cancer or in situ carcinoma of the cervix
* Patients who have been treated with neo-adjuvant chemotherapy or hormone therapy
A Prospective Study on Diabetes Management Through an Integrated Delivery System

1. To demonstrate a feasible hospital-based diabetic shared care model in Taiwan.
2. To compare effectiveness of diabetes control between patients receiving case management provided by a health manager and patients receiving usual care.
3. To determine the optimal level of glucose, blood pressure and lipids in control of diabetes in Taiwan.

Five general hospitals, including both public and private, are chosen as regional coordinating centers in this project. Collaborating with community physicians, project coordinating-centers randomize diabetic patients, who have signed informed consent, into either intervention or control group. While two annual comprehensive lab tests are offered to the control group, an additional package of consultations and coordinating services provided by health managers is appended to the intervention group. Qualified health managers are cultivated in five selected medical institutes to support primary care physicians in managing diabetic patients. Responsibilities of health managers include tracking and updating enrolled patients' information, providing adequate and scheduled consultations, arranging specialty referrals for patients in needs, and transferring stable patients back to their original physicians. The feasibility phase of the project implementation will last for three years and it will be followed by a phase of full-scale implementation for another two years. Glycemic control as well as health status of participants will be the indicators to evaluate outcome of the project. At the same time, the periodic measurements on glucose, blood pressures, lipids and the incidence of complications will also be analyzed to set up an optimal target for diabetic control in Taiwan.

Eligibility Criteria:
Inclusion Criteria:

1. Symptoms of diabetes plus casual plasma glucose concentration 200 mg/dl (11.1 mmol/l). Casual is defined as any time of day without regard to time since last meal. The classic symptoms of diabetes include polyuria, polydipsia, and unexplained weight loss.
2. Fasting plasma glucose 126 mg/dl (7.0 mmol/l). Fasting is defined as no caloric intake for at least 8 hours.

3.2-hour plasma glucose 200 mg/dl (11.1 mmol/l) during an oral glucose tolerance test (OGTT). The test should be performed using a glucose load containing the equivalent of 75-g anhydrous glucose dissolved in water.

Exclusion Criteria:

1. Type 1 diabetes (Insulin dependent diabetes, IDDM)
2. Women who are pregnant at the entry time.
3. Those who have history of myocardial infraction (MI), cerebrovascular accident (CVA), foot amputation and uremia under dialysis.
Identification and Treatment of Men With BPH in the Primary Care Setting

Male patients between the ages of 18 to 100 years of age who entered the Mid Michigan Health Center were administered a patient demographic questionnaire, a Lower Urinary Tract Symptom (LUTS) questionnaire, and the Men's Sexual Health Questionnaire (MSHQ) without exception. The purpose of this study was to better identify symptoms of benign prostatic hyperplasia (BPH) with the intent to prescribe better and more helpful treatment options for patients demonstrating these symptoms.


Eligibility Criteria:
Inclusion Criteria:

* All male patients between the ages of 18 to 100 years

Exclusion Criteria:

-