cyrilzakka/clinical-trials huggingface dataset:
Eflornithine To Prevent Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of eflornithine may be an effective way to prevent the recurrence of or further development of cervical cancer.

PURPOSE: Randomized phase II trial to determine the effectiveness of eflornithine in preventing cervical cancer in patients who have cervical intraepithelial neoplasia.

OBJECTIVES: I. Compare the efficacy of eflornithine versus placebo in causing regression in patients with cervical intraepithelial neoplasia. II. Compare the qualitative and quantitative toxicities of these treatment regimens in these patients. III. Establish the biochemical tissue markers of DNA content, PCNA, the ras oncogene, EGFR, and keratin and involucrin as intermediate biomarker end points for squamous carcinogenesis in these patients.

OUTLINE: This is a randomized, double blind, multicenter study. Patients are randomized to one of three treatment arms. Arm I-II: Patients receive one of two different doses of oral eflornithine daily. Arm III: Patients receive oral placebo daily. Treatment continues for 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed at 28 days, and then at 6, 12, 18, and 24 months.

PROJECTED ACCRUAL: A total of 180 patients (60 per treatment arm) will be accrued for this study.

Eligibility Criteria:
Inclusion Criteria:

1) Women with newly diagnosed or recurrent CIN grade 2-3, involving an area 3times larger than the biopsy site. Patients must be \> 18 years old, with a performance status less than or equal to 2 (Zubrod Scale) and a predicted life expectancy of greater than or equal to 12 months. Patients must have a medically safe form of contraception for the duration of the study. All patients must complete the of pretreatment evaluation, consent to colposcopy and cervical biopsy for histologic evaluation

Exclusion Criteria:

1) Patients may not have had a prior malignancy.
A Study of the Immunogenicity and Safety of Whole-Cell Pertussis Containing Vaccine Administered Concomitantly With RotaTeq™ (V260) or Rotarix™ (V260-036)(WITHDRAWN)

This study will evaluate the immunogenicity and safety of the pertussis component of DTwP (whole-cell pertussis containing vaccine) when administered concomitantly with RotaTeq™ or Rotatrix™.


Eligibility Criteria:
Inclusion Criteria:

* Healthy infants

Exclusion Criteria:

* History of abdominal disorders, intestinal folding, or abdominal surgery
* Impaired immune system
* Prior administration of any rotavirus vaccine or DTwP/DTaP
* Fever of \>= 38.1C (100.5F) at the time of vaccination
* History of prior rotavirus infection, chronic diarrhea, or failure to thrive
* Evidence of active gastrointestinal illness
Variation IGFBP7 Markers and TIMP2 Induced by Injection of Contrast Iodized Drug at the Intensive Care Patient

Multicenter, prospective, uncontrolled study to evaluate variations in urinary concentrations of TIMP-2 and PCI IGFBP7 induced injection during a CT scan in intensive care patient.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or more,
* Hospitalized in intensive care,
* Holders of a urinary catheter
* Patient receiving a first CT with intravenous injection of PCI during their ICU stay.
* Patient agreeing to participate in the research protocol

Exclusion Criteria:

* Anuria
* Need to retain urine, whatever the reason (eg measurement of 24-hour proteinuria).
* Urine unanalyzable whatever reason (eg urinary washing with double current probe, injection is saline to measure bladder pressure.).
* Patient subjected to renal replacement
* Patient already included in the study for a previous injection of PCI in intensive care.
Metabolic Control Adolescents Type 1 Diabetes

Purpose of the research; The aim of this study is to examine the effect of education including peer-interactive group support to be given to adolescents diagnosed with Type 1 diabetes with poor glycemic control in the 13-18 age group on metabolic control of adolescents.

The lack of a certificate program specific to pediatric diabetes nursing of the Ministry of Health in our country and the insufficient number of diabetes education nurses show that the pediatric population is not adequately trained to provide diabetes management. Along with these obstacles, the lack of use of an evidence-based standard education program reveals the need for effective intervention programs that include approaches specific to adolescents, who are a particularly risky group. Peer interaction can be used as an effective approach to increase adolescents' adherence to treatment. Thus, adolescents who isolate themselves are given the opportunity to cope with the disease and to share with other children. It has been determined that there is no study in the literature that includes peer-interactive group support on adolescents with a diagnosis of Type 1 diabetes who have poor glycemic control but have repeated hospitalizations. This situation shows that there is a need for a study to evaluate the effect of educational intervention including peer-interactive group support on repeated hospitalizations in adolescents with Type 1 diabetes.

Eligibility Criteria:
Inclusion Criteria:

* be between 13-18 years old
* Diagnosed at least 6 months ago
* HbA1C level \> 7.5
* Having repeated hospitalizations at least twice
* Living in Mersin city center
* Being able to communicate in Turkish
* Being able to read and write

Exclusion Criteria:

* - Using an insulin pump
* Having a chronic disease other than diabetes,
* Diseases that affect cognitive functions, hearing and vision impairments
Efficacy and Safety of ELGN-2112 on Intestinal Malabsorption in Preterm Infants

The study will evaluate the effect of ELGN-2112 on intestinal malabsorption in preterm infants.


Eligibility Criteria:
Inclusion Criteria:

* Male or female pre-term infant 26 and up to 32 weeks gestation. Gestational age matching (±2 weeks) between maternal dates and/or early antenatal ultrasound
* Birth weight ≥ 500g
* Singleton or twin birth

Exclusion Criteria:

-
Goserelin, Flutamine, and Radiation Therapy in Treating Patients With Locally Advanced Prostate Cancer

RATIONALE: Patient abstract not available

PURPOSE: Patient abstract not available

OBJECTIVES: I. Compare locoregional control, disease-free survival, and overall survival in patients with carcinoma of the prostate who are considered at high risk of relapse and receive long-term adjuvant zoladex (ZDX) vs. no adjuvant treatment following neoadjuvant ZDX/flutamide and radiotherapy. II. Compare sexual function in patients treated with these two regimens.

OUTLINE: Randomized study. Arm I: Neoadjuvant Antiandrogen Therapy and Releasing Factor Agonist Therapy plus Radiotherapy. Flutamide, FLUT, NSC-147834; and Zoladex, ZDX, NSC-606864; plus external-beam irradiation using megavoltage equipment with energies of at least 4 MV (at least 6 MV preferred). Arm II: Neoadjuvant Antiandrogen Therapy and Releasing Factor Agonist Therapy plus Radiotherapy followed by Adjuvant Releasing Factor Agonist Therapy. FLUT; and ZDX; plus external-beam irradiation using equipment as in Arm I; followed by ZDX.

PROJECTED ACCRUAL: 1,508 patients will be accrued over 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed, locally advanced adenocarcinoma of the prostate, including: Bulky primary tumors confined to the prostate (clinical Stage T2c) Primary tumors extending beyond the capsule (clinical Stage T3-4) No common iliac or para-aortic nodal involvement Regional lymph node involvement below the common iliac level allowed Positive nodes on imaging studies must be biopsied by FNA or surgical sampling PSA no more than 150 (mandatory) No distant metastases

PATIENT CHARACTERISTICS: Age: At least 50 Performance status: Karnofsky 70-100% Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No prior or concurrent second cancer except basal cell skin cancer No major medical or psychiatric illness that would prevent completion of treatment or interfere with follow-up

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: No prior hormonal therapy Radiotherapy: No prior radiotherapy Surgery: No prior radical surgery for carcinoma of the prostate
Usability and Feasibility of the NutriQuest Application

The study is a pilot study (phase 2) that includes a usability study (phase 1).

The aim of the study is to investigate the feasibility and usability of the healthy nutrition application and the effects on adherence to Modified Mediterranean diet, self-efficacy and nutrition knowledge among patients with cardiovascular disease in a cardiac rehabilitation setting. Furthermore, it studies the overall user experience when using the healthy nutrition application.

The study can be divided in two phases, each one addressing a specific research question:

1. Usability: Is the developed healthy nutrition application user-friendly and does it seem motivating for cardiac patients in a cardiac rehabilitation setting to use the application to eat more healthily?
2. Pilot study: Is the developed healthy nutrition application feasible and acceptable for cardiac patients? Does the healthy nutrition application have an effect on adherence to Modified Mediterranean diet, self-efficacy and nutrition knowledge in cardiac patients in a cardiac rehabilitation setting and what is the user experience?

Eligibility Criteria:
Inclusion Criteria:

* History of cardiovascular disease with or without intervention (PCI/CABG/conservative/pacemaker implantation/ablation)
* History of current or past cardiac rehabilitation in Jessa Hospital Hasselt
* Current treatment must require them to follow the Mediterranean diet plan
* Age ≥18 years
* Willing and physically able to follow a application-based healthy nutrition program and other study procedures in a six-week follow-up period
* Evidence of a personally signed and dated informed consent, indicating that the subject (or a legally-recognized representative) has been informed of all pertinent aspects of the study
* Possession of and/or able to use an Android based smartphone (version 6 or higher)
* Possession of internet connectivity
* Dutch speaking and understanding

Exclusion Criteria:

* Pregnant females
* Combined with diabetes or severe kidney disease
* Participation in other cardiac rehabilitation program trials, focusing on diet outcome
* Current or recent participation in other technology-supported programs, even when not directly targeting nutrition
* Any condition which in the opinion of the investigator would make it unsafe or unsuitable for the patient to participate in this study or a life expectancy of less than six weeks based on investigators judgment
Genotype-related Effects of PUFA

To assess the bioefficacy of omega-3 fatty acids (provided by intake of fish oil supplements) depending on genotype of relevant factors in lipid metabolism

To assess the bioefficacy of omega-3 fatty acids (provided by intake of fish oil supplements) depending on genotype of relevant factors in lipid metabolism.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult between 18 and 40 years of age
* BMI between 18.5 and 30 kg/m2
* Sedentary to moderate physical activity habits

Exclusion Criteria:

* Concomitant treatment: Consumption of dietary supplements or any medication that can affect the study outcomes
* Actively smoking
* Suspected abuse of alcohol or illicit drugs
* Significant illness within the two weeks prior to study start or any active systemic infection or medical condition that may require treatment during the study
* Known or suspected medical condition related to coagulation
* Subject who cannot be expected to comply with the study procedures
* Currently participating or having participated in another clinical trial during the last 4 weeks prior to beginning of this study
Post-Neoadjuvant Treatment MRI Based AI System to Predict pCR for Rectal Cancer

In this study, investigators seek for a better way to identify the potential pathologic complete response (pCR) patients form non-pCR patients with locally advanced rectal cancer (LARC), based on their post-neoadjuvant treatment Magnetic Resonance Imaging (MRI) data.

Previously, a post neoadjuvant treatment MRI based radiomics AI model had been constructed and trained. Here, the predictive power of this artificial intelligence system and expert radiologist to identify pCR patients from non-pCR LARC patients will be compared in this prospective, multicenter, back-to-back clinical study

This is a multicenter, prospective, observational clinical study for seeking out a better way to predict the pathologic complete response (pCR) in patients with locally advanced rectal cancer (LARC) based on the post-neoadjuvant treatment Magnetic Resonance Imaging (MRI) data. Patients who have been pathologically diagnosed as rectal adenocarcinoma and defined as clinical II-III stage will be enrolled from the Sixth Affiliated Hospital of Sun Yat-sen University, Sir Run Run Shaw Hospital and the Third Affiliated Hospital of Kunming Medical College. All participants should follow a standard treatment protocol, including neoadjuvant treatment, total mesorectum excision (TME) surgery. Patients with LARC who received neoadjuvant treatment will be enrolled and their post-neoadjuvant treatment MRI images will be used to predict their pathologic response (pCR vs. non-pCR). The artificial intelligence prediction system and the expert radiologist will define the pathologic response as pCR or non-pCR, respectively. The pathologist will provide the final pathology report of TME surgery specimen (pCR or non-pCR) as a standard. The predictive efficacy of these two back-to-back approaches generated will be compared in this multicenter, prospective clinical study.

Eligibility Criteria:
Inclusion Criteria:

* pathologically diagnosed as rectal adenocarcinoma
* defined as clinical II-III staging (≥T3, and/or positive nodal status) without distant metastasis
* receive neoadjuvant chemoradiotherapy or chemotherapy
* pre- and post-neoadjuvant treatment MRI data obtained
* receive total mesorectum excision (TME) surgery after neoadjuvant therapy and get the pathologic assessment of tumor response

Exclusion Criteria:

* with history of other cancer
* insufficient imaging quality of MRI to delineate tumor volume or obtain measurements (e.g., lack of sequence, motion artifacts)
* not completing neoadjuvant chemotherapy or chemoradiotherapy
* tumor recurrence or distant metastasis during neoadjuvant treatment
* not undergoing surgery resulting in lack of pathologic assessment of tumor response
Predicting the Risk of Post-operative Delirium: Use of Neuropsychology, Serum and CSF Biomarkers and Genetics to Predict Risk of Post-operative Delirium

The purpose of the study is to determine if pre-operative neuropsychological characteristics, apolipoprotein E4 status and/or cerebrospinal fluid (CSF) and serum biomarkers can predict those most at risk of post-operative delirium. Patients over the age of 65 years undergoing elective primary hip or knee arthroplasty in Musgrave Park Hospital are invited to take part. Participants undergo a pre-operative neuropsychological assessment which is repeated 6-12 weeks post-operatively at the time of surgical review appointment. At the time of surgery advantage is taken of the necessary venous cannulation and spinal anaesthetic to gain venous blood and CSF samples respectively. Venous blood is also sampled post-operatively. Patients are assessed daily for delirium, using the Confusion Assessment Method, until discharge. The association between delirium and subsequent cognitive decline is now well established in the literature. It is not yet clear whether this is solely because delirium following elective surgery indicates a previously unrecognised neurodegenerative process or whether the delirium itself exerts an additional pathophysiological insult. In order to investigate this, a follow-up study of these participants, approximately 8 years later is currently being conducted. Neuropsychological assessment and venous blood sampling will be repeated with consenting participants. Furthermore, the significance of subtle symptoms, not sufficient to fulfil the criteria for delirium and known as subsyndromal delirium, in relation to cognitive function years later will be analysed.


Eligibility Criteria:
Inclusion Criteria:

* living at home
* undergoing primary, elective hip or knee arthroplasty
* spinal anaesthetic with intrathecal diamorphine anticipated

Exclusion Criteria:

* neurological, hearing or visual disability affecting ability to participate in study
* known neurodegenerative condition eg dementia, Parkinson's disease, multiple sclerosis
Liposomal Doxorubicin, Trastuzumab, and Docetaxel in HER2 Positive Metastatic Breast Cancer

This is an open phase II study evaluating the efficacy and safety of the non pegylated liposomal doxorubicin (Myocet®), trastuzumab (Herceptin®), and docetaxel (Taxotere®) combination as first-line treatment of patients with metastatic HER2/neu positive breast cancer.

Phase II non comparative study, assessing the safety (primarily cardiac safety) and efficacy in patients with locally advanced or metastatic HER2/neu positive breast cancer not yet treated with chemotherapy for metastatic disease.

Myocet and Taxotere will be given for a maximum of 6 cycles, Herceptin treatment for 1 year is recommended.

Endpoints: cardiotoxicity (left ventricular ejection fraction decrease and/or symptoms of heart failure), serious other toxicity, disease progression.

Eligibility Criteria:
Inclusion Criteria:

* Women with histologically documented metastatic or locally advanced metastatic HER2/neu positive breast cancer at 1st line of palliative chemotherapy.
* In the case of previous adjuvant or neoadjuvant chemotherapy with anthracyclines or taxanes, this must have been completed more than 12 months before inclusion.
* In the case of previous adjuvant or neoadjuvant chemotherapy, cumulative anthracycline dose ≤ 240 mg/m2 of doxorubicin or 450 mg/m2 of epirubicin or 75 mg/m2 of mitoxantrone on inclusion.
* Previous endocrine therapy is authorized (endocrine therapy other than goserelin must be stopped before starting treatment).
* Previous radiotherapy is authorized, if discontinued ≥ 4 weeks prior to inclusion in the study and if \< 10% of the bone marrow was within the irradiated area.
* Age ≥ 18 years.
* Performance status 0,1, or 2.
* Life expectancy ≥ 3 months.
* Evaluable disease.
* Normal LVEF (multigated acquisition \[MUGA\] scan or echocardiography).
* Normal haematological, hepatic and renal parameters: neutrophils ≥ 1.5 x 10\^9/l; platelets ≥ 100 x 10\^9/l; hemoglobin (Hb) ≥ 6 mmol/L; total bilirubin ≤ 1.5 times the upper limit of normal (ULN); transaminases ≤ 2.5 x ULN; alkaline phosphatase ≤ 2.5 x ULN; creatinine ≤ 1.5 x ULN.
* Dated and signed written informed consent.

Exclusion Criteria:

* Previous chemotherapy for metastatic disease.
* History of other cancer, except for cervical carcinoma in situ treated by cone resection or basal cell or squamous cell skin cancer.
* History of congestive heart failure or myocardial infarction ≤ 1 year; cardiac function: NYHA ≥ 2 or LVEF \< 50%.
* Uncontrolled significant heart disease, such as unstable angina.
* Poorly controlled hypertension.
* Performance status 3, 4.
* Symptomatic or progressive brain metastases.
* Active infection or other serious underlying disease.
* Concomitant participation in other clinical trials.
* Pregnant women or nursing mothers; patients of childbearing potential without effective contraception.
* Absolute medical contraindication to the use of corticosteroid premedication.
* Allergy to polysorbate 80, doxorubicin, or egg lecithin.
* NCI-CTC grade \> 1 peripheral neuropathy.
* Patients not able to comply with regular medical follow-up
Outcomes of Angiotensin Converting Enzyme Inhibitor Management Strategies Prior to Coronary Artery Bypass

Coronary artery disease is a leading cause of death, hospitalization, and health care costs in developed nations. Coronary revascularization with coronary artery bypass graft (CABG) surgery improves the long term survival in patients with diabetes and multi-vessel disease. Angiotensin converting enzyme inhibitors (ACE) and angiotensin receptor blockers (ARB) reduce mortality and subsequent cardiac events in patients with coronary artery disease undergoing CABG surgery when initiated at least 4 weeks pre-operatively. Observational data have suggested that pre-operative ACE administration is associated with an increased risk of post-operative vasoplegic shock, acute kidney injury, and mortality; however, other studies have failed to confirm these findings and further suggested ACE are associated with a reduced risk of peri-operative myocardial infarction. A single trial of 40 CABG patients randomized to pre-operative ACE withdrawal or continuation reported that the withdrawal group required significantly fewer vasopressors during cardiopulmonary bypass but more intravenous vasodilators post-operatively to control hypertension. Hence, it remains unclear whether ACEs should be held or continued immediately prior to CABG surgery and a survey of cardiac surgeons suggests that current clinical practice is divided. This pilot study aims to establish the feasibility of the study design and to determine the frequency of clinical endpoints among patients who continue and discontinue ACE prior to cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective or urgent isolated CABG and/or valvular repari or replacement surgery
* On an ACE or ARB for a minimum of 7 days

Exclusion Criteria:

* Emergency surgery
* Pre-operative shock (defined as systolic blood pressure \< 90 mmHg, the need for any vasopressor or inotropic support, or a mechanical cardiac support device)
* Severe uncontrolled pre-operative hypertension (defined as blood pressure ≥ 200 mmHg systolic or ≥120mmHg diastolic mmHG or the pre-operative need for intravenous anti-hypertensive agents)
* ACE or ARB therapy \< 7 days
* Any mineralocorticoid receptor antagonist therapy.