cyrilzakka/clinical-trials huggingface dataset:
Risk of Hepatitis B Reactivation in Patients With Prior HBV Exposure Undergoing Rituximab-containing Chemotherapy: A Prospective Study

The purpose of this study is to determine whether preemptive nucleoside analogue therapy or regular virologic monitoring is the preferred method in management patients with prior exposure to hepatitis B vius (HBV) and undergoing rituximab-containing chemotherapy.

Occult hepatitis B virus (HBV) reactivation has been documented in patients undergoing rituximab-containing chemotherapy who are hepatitis B surface antigen (HBsAg)-negative but with serologic evidence of prior exposure to HBV. However detailed prospective studies documenting the incidence of reactivation and the virologic and serologic kinetics of reactivation are lacking. The investigators prospective study proposes to follow-up 70 such patients with all serologic and virologic parameters monitored every 4 weeks. Patients with detectable HBV DNA will be started on nucleoside analogue therapy. The optimal method and duration of monitoring will also be determined from our study.

Eligibility Criteria:
Inclusion Criteria:

* Documented HBsAg-negative with or without antibody to hepatitis B surface antigen (anti-HBs)
* Documented anti-HBc (total)-positive

Exclusion Criteria:

* Concomitant liver diseases including chronic hepatitis C and D infection, Wilson's disease, autoimmune hepatitis, primary biliary cirrhosis and primary sclerosing cholangitis.
* Significant alcohol intake (\>30 grams per day)
Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid

The primary objective is, first, the comparison of tamoxifen and anastrozole and, second, the comparison of zoledronate added to standard adjuvant therapy with controls according to disease-free survival (DFS) in premenopausal patients with non-metastatic breast cancer treated with tamoxifen or anastrozole. To assess whether zoledronate added to standard adjuvant therapy can decrease or even prevent bone loss in patients treated with hormonal blockade combined with an antiestrogen or aromatase inhibitor.

The trial is conducted as an open multi-center phase III study, in a two-factorial study design and according to Good Clinical Practice (GCP) guidelines. Patients will be randomly assigned to a total of 4 study groups in a 1:1:1:1 assignment ratio. Several stratification criteria will be used in order to ensure balanced distribution of known risk factors.

A total of 1.803 patients will be enrolled in 4 arms. Patients will either be treated with anastrozole (1mg daily for 3 years) or tamoxifen (20mg daily for 3 years), and will additionally receive either zoledronate (8mg q4 weeks for 3 years) or no zoledronate (arm A: Nolvadex alone; arm B: Nolvadex plus zoledronate; arm C: Arimidex alone; arm D: Arimidex plus zoledronate).

Zoledronate will be administered by i.v. injection at a dose of 4 mg/month for the treatment period of 3 years. Five Bone Mineral Density (BMD) measurements will be performed in a subgroup of patients (404 patients, enrolled in 3 centres).

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal, hormone receptor-positive patient
* Histologically verified (minimally) invasive breast cancer, local radical treatment
* 0-9 involved axillary lymph nodes (≥ 10 histologically examined nodes)
* Tumor stage: pT1b-3, yT0 or yT1a

Exclusion Criteria:

* T1a, T4d, yT4; M1
* Previous breast tumor irradiation
* Previous or concurrent chemotherapy (except for preoperative chemotherapy)
* Serum creatinine \> 1.5 x UNL or creatinine clearance \< 60 ml/min
Delivering a Diuretic Into the Liver Artery Followed by Plugging up the Artery to Starve Out Liver Cancer Cells

The purpose of this study is to test the safety of Bumetanide , at different doses to find out what effects, if any, it has on people who undergo tumor TAE as part of their regular care. Bumetanide is a commonly used medication to reduce the amount of water in the body.


Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnoses of HCC according to European Association for the Study of Liver disease (EASL) criteria for diagnosis (See Appendix 1). Regional lymphadenopathy will be allowed.

  * Any virus status accepted (e.g. Hepatitis C etc.)
  * Any prior liver treatment
* Patients within unresectable HCC
* At least 18 years old
* ECOG performance status 0 or 1
* Radiographically measurable disease per mRECIST 1.1
* Meets standard of care to undergo embolization

Exclusion Criteria:

* Women who are pregnant or lactating
* Documented hypersensitivity to bumetanide or sulfonamides
* Patients with resectable HCC
* High risk for post-embolization hepatic failure:

  °Child's C cirrhosis

  °\> 80% liver involvement by tumor
* Contraindication to angiography/embolization including:

  * Patients cannot receive contrast:
  * Severe allergic reaction to contrast despite premedication
  * Poor renal function not on dialysis
  * Other, based on judgment of the investigator
* ECOG score 2
* Main portal vein tumor thrombus
* BCLC D = patients with distant metastasis
Management of Metastatic Colorectal Cancer: A Clinical and Patient Perspective

A Real World Evidence Prospective Cohort Study in the Management of Metastatic Colorectal Cancer: A Clinical and Patient Perspective


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Diagnosis of mCRC
* Having had two disease progressions since diagnosis of first metastasis that led to first systemic treatment.

Exclusion Criteria:

* Currently participating in an investigational clinical trial (thus it does not apply to observational cohort studies)
* Currently being treated for other cancer(s)
* Not having mental capacity and/or ability to participate in the study
Clinical Governance of Patients With Acute Coronary Syndrome in Italy

This is a prospective, observational, multicenter study that enroll consecutive and all-comers patients hospitalized with a diagnosis of Acute Coronary Syndrome (ACS) at admission.

This is a Quality Improvement Program which enroll all the consecutive patients hospitalized with ACS. The data elements that are central to the study include the primary and secondary quality indicators (QIs) that are used to define the performance and to promote improved quality of care.

At least 3000 patients will be enrolled. The primary endpoint are assessed in-hospital, at admission and discharge. Patients will be followed for 1 year after the ACS.

Eligibility Criteria:
Inclusion Criteria:

* STEACS patients: symptoms of myocardial ischemia and persistent (i.e. \> 20 min) ST elevation in at least two contiguous ECG leads. N.B. Positive biomarkers of cardiac necrosis (i.e. troponin) are not required to confirm the diagnosis. New or presumably new left-bundle branch block at presentation occurs infrequently, may interfere with ST-elevation analysis, and should not be considered diagnostic of acute myocardial infarction (MI) in isolation.
* NSTE-ACS patients: symptoms of myocardial ischemia of at least 10 minutes without persistent ST elevation in at least two contiguous ECG leads. To be included in this category patients should have at least one of the following two conditions: a) ECG evidence of NSTEACS defined as T wave inversion in leads with dominant R waves of at least of at least 1 mm (100 μV) or ST segment depression of at least 0.5 mm (50 μV) and/or b) Biomarker evidence of NSTEACS defined as at least one positive (i.e. above the 99th percentile upper reference limit) troponin value (i.e. NSTEMI)
* A written informed consent (to agree for a contact, usually by telephone) is required only to patients who are discharged alive.

Exclusion Criteria:

* Subjects who, in the opinion of the investigator, are unable to comply with study follow up procedures, including, but not limited to, patients who are in prison, who are expected to move to a remote country, or who refuse to be followed should be excluded.
Ketamine IV Classic Protocol : Five Years Follow up

Patients who suffer from MDD recieved ketamnie (2014-15) in open study will be addressed and there depression mood will be evaluated using the rating scale that were used in the original research. In addition time of relapse and questions about their medications and drug use will be performed.

Patients who suffer from Major Depressive disorder and are outpatients in our clinic and, received in the years (2014-15) ketamine in open study will be addressed and there depression mood will be evaluated using the rating scale that were used in the original research. In addition time of relapse and questions about their medications and drug use will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Patient who participated in ketamine study 1126

Exclusion Criteria:

* None
Pulmonary Rehabilitation in COPD: Effects of Two Aerobic Exercise Intensity in Patient-centered Outcomes

Trial design: An equivalence/non-inferiority randomized controlled trial with parallel group design studied the effect of two aerobic exercise-training intensities in COPD patient-centered outcomes. Methods: Thirty-four COPD clinically stable patients stratified from mild to very severe GOLD stages, were blinded to 60 or 80%Wmax aerobic exercise training intensity in an outpatient pulmonary rehabilitation program, between 2009-2010. Outcomes were assessed with St.George's respiratory questionnaire (primary outcome), Mahler dyspnea index, London Chest activity of daily living scale, 6-minute walk, constant load and incremental exercise tests. Patient's allocation sequence was computer-generated, with consignment in a safe deposit box.


Eligibility Criteria:
Inclusion Criteria:

* Clinically stable COPD
* FEV1/FVC \< 70%
* Exercise training medical referral

Exclusion Criteria:

* Unable to attend 3-times/week program
* Infectious disease
* Metastatic cancer
* Unstable heart disease
* Neuromusculoskeletal disorder
* Cognitive or psychiatric disorder
A Clinical Trial to Evaluate Bioavailability and Effect of Food for Sotorasib in Healthy Participants

The primary objectives of the study are to compare the pharmacokinetics (PK) and demonstrate relative bioavailability of sotorasib administered as 4 oral tablets (test) to sotorasib administered as 8 oral tablets (reference) and to assess the effect of food on the PK of sotorasib administered as 4 oral tablets.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female participants, between 18 and 60 years of age (inclusive), at the time of Screening.
* Body mass index, between 18 and 32 kg/m2 (inclusive), at the time of Screening
* Females of nonchildbearing potential
* In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia \[e.g., suspicion of Gilbert's syndrome based on total and direct bilirubin\] is not acceptable) as assessed by the Investigator (or designee).

Exclusion Criteria:

* Inability to swallow oral medication or history of malabsorption syndrome.
* History of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee) and in consultation with the Sponsor.
* Poor peripheral venous access.
* History or evidence, at Screening or Check in, of clinically significant disorder, condition, or disease, including not otherwise excluded that, in the opinion of the Investigator (or designee), would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
* History or evidence of clinically significant arrhythmia at Screening, including any clinically significant findings on the ECG taken at Check-in.
* History suggestive of esophageal (including esophageal spasm, esophagitis), gastric, or duodenal ulceration or bowel disease (including but not limited to peptic ulceration, gastrointestinal bleeding, ulcerative colitis, Crohn's disease, or irritable bowel syndrome), or a history of gastrointestinal surgery other than uncomplicated appendectomy and hernia repair. History of cholecystectomy is not permitted.
* Estimated glomerular filtration rate (eGFR) less than 70 mL/min/1.73 m² as calculated by the Modification of Diet in Renal Disease (MDRD) equation, at Screening or Check-in.
* ALT or AST \> ULN, at Screening or Check-in.
* Thyroid-stimulating hormone outside normal range.
* Positive hepatitis B or hepatitis C panel and/or positive human immunodeficiency virus test, at Screening. Participants whose results are compatible with prior immunity (vaccination or prior infection) may be included.
* Use of any over-the-counter or prescription medications within 30 days or 5 half-lives (whichever is longer) before enrollment. Acetaminophen (paracetamol) (up to 2 g per day) for analgesia will be allowed. Hormone-replacement therapy (e.g., estrogen) will be allowed.
The Predictors for Continuous Renal Replacement Therapy in Liver Transplant Patient

Background. Acute renal failure after liver transplantation (LT) requiring continuous renal replacement therapy (CRRT) adversely affects patient survival. However, there are few reports to assess the predictors for postoperative CRRT in liver transplant patients. The investigators undertook this study to identify perioperative factors that would predict patients at risk of CRRT.

Patients and Methods. The investigators retrospectively reviewed the data of 148 liver transplant patients from January 2007 to November 2010 at Severance Hospital, Yonsei University HealthSystem, in Seoul, Korea. The number of patients treated with CRRT was 44 (18 patients from living and 26 from deceased donors) and those without CRRT was 104. Univariate and stepwise logistic multivariate analyses were performed.


Eligibility Criteria:
Inclusion Criteria:

* Age 19-65 year
* Liver transplant patients from January 2008 to December 2011

Exclusion Criteria:

* Patients treated with CRRT before transplantation
PROspective Longitudinal All-comer Inclusion Study in Eating Disorders

The PROLED study is a prospective and longitudinal study of patients with Eating Disorders. Annual interviews and collection of biological samples are done, as well as during changes in disease course e.g. during hospitalization. Included are qualitative interviews, psychometric tests, questionnaires which are used to collect data on psychopathology. There is also collection of blood, urine and faeces.

The objective is to increase the understanding of the psychopathology and pathophysiology of Eating Disorders.

More specifically, the aim is to identify biomarkers that relate to prognosis, disease course and response to treatment as usual of Eating Disorders, and, to improve the understanding of the pathophysiology of Eating disorders in order to identify novel molecular targets for treatment.

Rationale The etiology of Eating Disorders (ED's) is unknown. Previous studies have identified genes that link Anorexia Nervosa to other psychiatric (e.g. schizophrenia) and somatic disorders (e.e. diabetes). Association studies have also suggested genetic causes underlying Bulimia Nervosa and Binge Eating Disorders. The PROLED study aims to improve the understanding of both the psychopathology and pathophysiology of Eating Disorders. No experimental drug will be used in this study.

There is a great need for an increased biological understanding of ED's in view of the prevalence, the costs, the severity and high mortality rates, and the lack of efficient treatments. The PROLED study aims to answer questions related to these unmet medical needs.

The study design is prospective and longitudinal. Qualitative interviews, psychometric tests, questionnaires are used to collect data on psychopathology. There is also collection of blood, urine and faeces.

Eligibility Criteria:
Inclusion Criteria:

* Eating Disorder (ICD-10)

Exclusion Criteria:

* Forced care/non-voluntary
Sedative Effects in Obstructive Sleep Apnea

The objective of this study is to determine the effect of dexmedetomidine infusion on the Apnea / Hypopnea Index (AHI) of individuals with previously documented obstructive sleep apnea. We hypothesize that dexmedetomidine infusion may reduce the AHI in patients with obstructive sleep apnea (OSA).


Eligibility Criteria:
Inclusion Criteria:

* All individuals who have previously undergone diagnostic polysomnography in the Sleep Lab which documented significant OSA, and who have not undergone any changes that are likely to alter the severity of their condition since the time of their diagnostic sleep study (loss of weight; surgical therapy for OSA; removal of tonsils; discontinuation of medications likely to affect arousal or respiratory function, etc.) are eligible to participate. Subjects will be identified as they complete outpatient sleep studies or from records of previous sleep studies performed in the Duke Sleep Laboratory. After obtaining informed consent, subjects will be screened by history and physical examination, 12-lead electrocardiogram, and comprehensive metabolic profile.

Exclusion Criteria:

* Exclusion criteria will include a history of illicit drug or alcohol dependence, impaired hepatic (aspartate aminotransferase or alanine aminotransferase \> 2x upper limit of normal range) or renal function (receiving dialysis or serum creatinine \> 1.5 mg/dL), high-grade (\> 1st degree) heart block, or known allergy to dexmedetomidine.
Community Partnership for Telehealth Solutions to Counter Misinformation and Achieve Equity

Non-randomized, two-arm stepped-wedge trial of a multi-level colorectal cancer screening intervention.

The PRIME study aims to improve colorectal cancer (CRC) screening and follow-up among predominantly Latinx populations by using video text messages, mailed FIT kits, and patient navigation. The study will address multi-level barriers to screening, including misinformation, lack of access, and social determinants of health. The hypothesis is that a multi-component intervention will increase CRC screening rates and follow-up care, reducing disparities in CRC outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Ages 45-64
* Eligible for colorectal cancer (CRC) screening
* Current patients (seen in the clinic in the last 6 months)
* Primary speaker of English or Spanish
* Cell phone listed in Electronic Health Record (EHR)
* No recent history of CRC screening
* Resides in one of the neighborhoods included in the main trial

Exclusion Criteria:

* Colorectal disease (e.g., ulcerative colitis or colectomy)
* Personal history of colorectal cancer
* End-stage or life-threatening diseases
* Known to be under hospice care
* Living in a skilled nursing facility
* Patients who decline research participation will be removed from the patient contact list
Estimation of the Effective Dose (ED) 95 of Intrathecal Hyperbaric Prilocaine 2% for Scheduled Cesarean Delivery.

Prilocaine is a local anesthetic drug which as an intermediate duration of action shorter than bupivacaine 0,5% that is usually used for spinal anesthesia in scheduled cesarean section. No study has yet investigated the use of hyperbaric (HB) prilocaine 2% for intrathecal anesthesia in cesarean section. The aim of this study is to determine the Effective Dose (ED) 95 of hyperbaric (HB) prilocaine 2% by using the Continual Reassessment Method (CRM)


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status (ASA) \< III
* Age 18-40 year
* Body Weight \<100 kg
* Height between 160 and 175 cm
* Gestational age\>37 SA
* Elective cesarean delivery
* Singleton pregnancy
* Non complicated pregnancy
* Signed informed consent obtained prior to any study specific assessments and procedures

Exclusion Criteria:

* Twin pregnancy
* History of 2 cesarean section or more
* Diabetes and gestational diabetes
* Placenta praevia
* Congenital foetal abnormality
* Patient in labour
* Membrane rupture
* Known allergy to local anaesthetics
* Disagreement of the patient
* Pregnancy-induced hypertension
* Pre eclampsia and eclampsia
Disability and Self-rated Health Following Primary Knee Replacement

Knee replacement is an effective treatment in late-stage osteoarthritis. It reduces pain and improves quality of life. There is, however, limited data concerning its results in older people and on its effect on how patients survive in regular activities of daily living (ADL), such as bathing and shopping. In this study, the results of knee replacement are evaluated from the point of view of disability in everyday activities and self-rated health. Moreover, association with ADL performance and clinical knee scores and severity of osteoarthritis are assessed.

This is a cross-sectional study with a 12 month follow-up for recruited patients. Most data are gathered by a postal questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* age 75 years or more at the time of operation
* diagnosis of knee osteoarthritis
* scheduled for or operated on with primary knee replacement

Exclusion Criteria:

* died during the follow-up
* inflammatory arthritides
A Trial of RAD001/Capecitabine in Refractory Gastric Cancer

Capecitabine is an oral fluoropyrimidine that has been shown to be effective in the treatment of metastatic gastric and colorectal cancer patients. On the basis of capecitabine-based chemotherapy which is accepted as a standard regimen in gastric cancer, we will perform the phase I/II study with all-oral regimen of RAD001 with capecitabine for these refractory gastric cancer patients.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically proven gastric cancer patients
2. Adequate organ function as defined by the following criteria:

   A. Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase (SGOT)) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase (SGPT)) ≤ 2.5 x local laboratory upper limit of normal (ULN), or AST and ALT less than or equal to 5 x ULN if liver function abnormalities are due to underlying malignancy B. Total serum bilirubin ≤ 3.0 mg/dL C. Absolute neutrophil count (ANC) ≥1500/µL D. Platelets ≥100,000/µL E. Hemoglobin ≥9.0 g/dL (may be transfused or erythropoietin treated) F. Serum calcium ≤12.0 mg/dL G. Serum creatinine ≤1.5 x ULN
3. Patients with CNS metastasis must have stable neurologic function without evidence of CNS progression within 8 weeks
4. Patients who have failed to at least two previous cytotoxic chemotherapy for advanced gastric cancer (adjuvant treatment will be counted as one regimen if received \< 12 months from the start of experimental treatment)
5. At least one measurable lesion by RECIST criteria
6. ECOG PS 0-2
7. Patients with informed consent

Exclusion Criteria:

1. Major surgery or radiation therapy within 4 weeks of starting the study treatment.
2. History of or known carcinomatous meningitis, or evidence of symptomatic leptomeningeal disease on screening CT or MRI scan.
3. Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥ 2.
4. Pregnancy or breastfeeding.
5. Prior exposure to the study drug.
6. Patients unable to swallow oral medications.