Kornimate/medical-research-clean huggingface dataset:
an observational study on the safety profile of mabthera/rituxan (rituximab) in combination with chemotherapy in patients with b cell-lineage chronic lymphocytic leukaemia (maberyc)

Conditions: Lymphocytic Leukemia, Chronic

Summary: this prospective observational study will evaluate the safety of mabthera/rituxan (rituximab) in combination with chemotherapy in patients with previously untreated or relapsed/refractory b cell-lineage chronic lymphocytic leukaemia. data will be collected from each patient for 6-12 months, depending on the prescribed chemotherapy regimen.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * b cell-lineage chronic lymphocytic leukaemia (b-cll) * prescribed with mabthera/rituxan in combination with chemotherapy according to the approved smpc * informed consent to data collection exclusion criteria: * treatment with any marketed or non-marketed drug substance or experimental therapy within 4 weeks prior to first dose of study drug or participation in a clinical trial within 30 days prior to entering this study * any other tumour disease
frequency of diagnostic symptomatic pulmonary embolism's in patients hospitalized for clinical exacerbation of chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease; Patients Hospitalized for a COPD Exacerbation

Summary: a standardized diagnostic strategy of pulmonary embolism will be applied to eligible patients, incorporating a clinical probability score (revised geneva score), plasma d-dimer assay and if necessary, a multidetector-row ct angiography thoracic and venous ultrasound of the lower limbs. all the patient with a pulmonary embolism diagnosed or not, will be followed for 3 months.


Eligibility criteria:
inclusion criteria: * patients hospitalized for a copd exacerbation * copd previously diagnosed exclusion criteria: * allergy to iodinated contrast * creatinine clearance \< 30 ml / min * patient hospitalized for exacerbation of copd for more than 48 hours * pneumothorax * exams impossible to be performed * pregnancy * life expectancy \< 3 months * patients already receiving anticoagulant therapy for another reason (mechanical valve, cardiac arrhythmia).

Keywords: copd exacerbation pulmonary embolism standardized and consensus diagnostic strategy
long-term safety of spd489 when added to stable doses of antipsychotic medications in clinically stable adults with negative symptoms of schizophrenia

Conditions: Schizophrenia

Summary: the primary purpose of this study is to determine if the long-term use of spd489 (40, 80, 100, 120, 140, and 160mg) administered as a daily morning is safe and tolerable.

not required

Eligibility criteria:
inclusion criteria: * 18 to 65 years of age * has a reliable informant (eg, family member, social worker, caseworker, or nurse that spends \>4 hours/week with the subject) * fixed home/place of residence and can be reached by telephone * on a stable dose of antipsychotic medications * able to swallow capsules exclusion criteria: * -taking lithium, carbamazepine, lamotrigine, gabapentin, cholinesterase inhibitors, modafinil, or other stimulants such as methylphenidate and other amphetamine products * treated with clozapine in past 30 days * lifetime history of stimulant, cocaine, or amphetamine abuse or dependence * history of seizures (other than infantile febrile seizures), any tic disorder, or current diagnosis and/or a known family history of tourette's disorder, serious neurological disease, history of significant head trauma, dementia, cerebrovascular disease, parkinson's disease, or intracranial lesions * uncontrolled hypertension * history of thyroid disorder that has not been stabilized on thyroid medication * glaucoma * pregnant or nursing * subject has received an investigational product or participated in a clinical study within 30 days

Keywords: not required
covid-19-study of immune responses following vaccination against sars-cov-2

Conditions: Cancer; Elderly; Healthy Aging

Summary: t-cell adaptive immunity is known to be required to sustain a long term immunoglobulin production and a long term memory against several infections. previous results suggest a lack in the generation of t-cell responses against cov-n, m and s proteins among cancer patients exposed to sars-cov-2 virus highlighting that cancer patients failed to mount a protective t-cell immunity. given this context, our hypothesis is that covid-19 vaccine candidates are not immunogenic in some cancer patients. thus, the monitoring of cd4 and cd8 t-cell responses before and after vaccination might provide information related to the correlation between induction of cd4 t-cells (including helper follicular t-cells) by the vaccine and long-term igg production (serological index). additionally, the failure of covid-19 vaccines in some patients should be monitor carefully in order to provide specific recommendations to avoid covid-19 infections. the main objective is to assess humoral immune responses following covid-19 vaccination in a population of cancer patients.


Eligibility criteria:
\*inclusion criteria: * male or female patients * age ≥ 18 years * not having developed a symptomatic form of covid-19 within the last 3 months before inclusion * eligible to the vaccination against sars-cov-2 * affiliation to french social security or receiving such a regime, * signed informed consent * ability to comply with the study protocol, in the investigator's judgment cancer patients * patients under active anticancer treatment: in adjuvant or neoadjuvant setting or in first line of treatment in metastatic setting. except for prostate cancer (until metastatic castration-resistant prostate cancer); and breast cancer hormonal receptor positive/her2 negative (until apparition of hormonal resistance). * patients in follow-up (active treatment \< 3 months). elderly: age ≥ 70 years old healthy person: age ≥ 18 years old and \< 70 years old \*exclusion criteria: * patient under guardianship, guardianship or under the protection of justice * receipt of a live, attenuated vaccine within 4 weeks prior to the initiation of treatment or anticipation that such a live, attenuated vaccine will be required during the study.

Keywords: vaccination t cell sars-cov-2 covid-19 cancer
celebrex and metformin for postoperative hepatocellular carcinoma

Conditions: Liver Cancer

Summary: this prospective trial aims to compare the role of celebrex alone, metformin alone, and celebrex plus metformin in preventing hcc recurrence after hepatic resection.

hepatic resection is a popular curative treatment for patients with early-stage hcc and well-preserved liver function. although overall survival after resection has been increasing, the median 5-year disease-free survival rate after resection remains at only about 37% for early-stage hcc. in fact, the 5-year recurrence rate is as high as 74% for intermediate and advanced hcc. postoperative recurrence may be due to intrahepatic metastasis arising from the primary tumor or it may be de novo metastasis (multicentric) that arises spontaneously in the residual liver. intrahepatic metastasis is the primary mechanism of early recurrence, which occurs \<2 years after resection; multicentric metastasis is the principal mechanism behind late recurrence, which occurs at least 2 years after resection. in the past few years, some observational studies with small sample size found metformin and celebrex (selective cyclic oxidase-2 inhibitors) may reduce the rate of hcc after surgery. however, no prospective study compare their efficacy in preventing hcc recurrence. this trial aims to compare the role of celebrex alone, metformin alone, and celebrex plus metformin in preventing hcc recurrence after hepatic resection.

Eligibility criteria:
inclusion criteria: * age 18-75 years * diagnosis of hcc was confirmed by histopathological examination of surgical samples in all patients * patients have child-pugh a or b liver function * no previous neoadjuvant treatment * no evidence of macrovascular invasion, metastasis to the lymph nodes and/or distant metastases on the basis of preoperative imaging results and perioperative findings * no malignancy other than hcc for 5 years prior to the initial hcc treatment exclusion criteria: * history of cardiac disease * known history of human immunodeficiency virus (hiv) infection * known central nervous system tumors including metastatic brain disease * history of organ allograft * substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results * any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study pregnant or breast-feeding patients
regional block of the nose for hypotensive anaesthesia in septo-rhinoplasty

Conditions: Hypotensive Anesthesia

Summary: septorhinoplasty is a cosmetic surgery that many people are choosing to undergo. it can be done under general anesthesia, twilight anesthesia or regional anesthesia. controlled hypotensive anesthesia is required to minimize bruising, swelling, and bleeding that reduces visibility in the operative field and hence satisfactory surgical outcome. the goal of our study to prove that regional block of the nose provides efficient hypotensive anesthesia


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) physical status i-ii * scheduled for elective septo-rhinoplasty surgery exclusion criteria: * patients with hypertension or coronary artery disease, * patients with renal, hepatic or cerebral insufficiency, * patients with coagulopathy or receiving drugs influencing blood coagulation, * patients with known sensitivity to any of the study drug
mental health, gender-based violence, and stunting in tanzania

Conditions: Mental Health Issue; Substance Use; Child Development

Summary: one in three children under the age of five in tanzania experience stunting, which is defined as impairments in growth and development that often occur after poor nutrition, poor health, and low psychosocial stimulation. research suggests that mental health problems of parents may be related to stunting outcomes and parental mental health is closely related to experiences of intimate partner violence, also called gender-based violence. however, very little research exists on the connection between these elements, and interventions may be necessary in order to reduce the impacts that mental health and gender-based violence may have on stunting. this study is a secondary data analysis of de-identified survey and stunting data that were conducted as a part of a needs assessment by a local nonprofit organization in tanzania. the needs assessment was conducted to inform a mental health initiative organized by the established nonprofit across 5 villages in rural tanzania. this project's primary aims are: * to determine the prevalence of mental health and family relationship problems in five villages * to determine associations between intimate partner violence (ipv) mental health and substance use and childhood stunting


Eligibility criteria:
inclusion criteria: * living within the 5 rural villages * participating in a local nonprofit * pregnant or having a child under 2 years old exclusion criteria: * living outside of the 5 villages * not participating in the local nonprofit * not pregnant or having a child under 2 years old
neoadjuvant chemotherapy for elderly with pancreatic head cancer

Conditions: Pancreatic Cancer Resectable; Pancreatic Cancer Stage II; Neoadjuvant Therapy; Elderly; Borderline Pancreatic Inoperable Cancer

Summary: the goal of this observational retrospective cohort study is to evaluate the efficacy and safety of neoadjuvant chemotherapy (nat) in elderly patients with resectable or borderline resectable (br) pancreatic ductal adenocarcinoma (pdac). the study includes patients aged ≥70 years who have undergone nat followed by surgery or upfront surgery. the main questions it aims to answer are: does nat improve overall survival (os) and progression-free survival (pfs) in elderly patients compared to upfront surgery? what is the impact of nat on r0 resection rates, conversion rates in br tumors, and the need for vascular resection? how does the toxicity profile of different nat regimens affect treatment outcomes and patient tolerability? researchers will compare nat followed by surgery vs. upfront surgery to determine differences in oncologic outcomes and postoperative complications. participants will: be retrospectively identified from hospital records. be classified based on treatment received (nat vs. upfront surgery). undergo data collection on tumor characteristics, treatment regimens, surgical details, and survival outcomes. this study aims to refine patient selection criteria for nat in elderly patients, guiding personalized treatment strategies to optimize survival and quality of life.


Eligibility criteria:
inclusion criteria * patients aged ≥ 70 years * patients with resectable or br pdac who underwent curative treatment (nat followed by surgery and upfront surgery) * patients with eastern cooperative oncology group (ecog) performance status (ps) \> 2 * patients able to provide informed consent, whenever possible exclusion criteria * patients not meeting the inclusion criteria. * pancreatic cancer of pancreatic body and tail. * patients with metastatic disease. * patients with locally advanced or metastatic pancreatic cancer
utilizing holmium laser for furs renal stone lithotripsy comparing stone breaking vs. stone dusting settings

Conditions: Stone Clearance

Summary: twenty (20) subjects presenting with a renal stone and candidates for furs (flexible ureteroscopic renal surgery) will undergo a single furs procedure for a kidney stone as part of the study, using the study device. these subjects will be randomized into stone breaking treatment or stone dusting.

twenty (20) subjects presenting with a renal stone and candidates for furs (flexible ureteroscopic renal surgery) will undergo a single furs procedure for a kidney stone as part of the study, using the study device. these subjects will be randomized into stone breaking treatment or stone dusting.

Eligibility criteria:
inclusion criteria: 1. subject will be older than 18 years of age 2. subject was diagnosed with renal calculi meeting the following criteria: * largest stone measures no more than 2cm on a single diameter and is no less than 0.8cm as defined by x-ray or ct. * accumulative stone burden (addition of all stone diameters) is no more than 2.5cm. 3. subject is a candidate for furs procedure 4. subject is willing and has signed the informed consent form exclusion criteria: 1. subject has undergone a previous treatment for stones in the same kidney 2. subject requires another, concomitant procedure, other than furs, to be performed during this treatment session. 3. female subject is pregnant 4. concomitant anticoagulant medication that cannot be suspended during surgery
study of epratuzumab versus placebo in subjects with moderate to severe general systemic lupus erythematosus (sle)

Conditions: Systemic Lupus Erythematosus

Summary: the primary objective of the study is to confirm the clinical efficacy of epratuzumab in the treatment of subjects with systemic lupus erythematosus (sle).


Eligibility criteria:
inclusion criteria: * positive antinuclear antibodies (ana) at screening (visit 1) * current clinical diagnosis of systemic lupus erythematosus (sle) by american college of rheumatology (acr) criteria such that at least 4 of the 11 criteria are met * active moderate to severe sle activity as demonstrated by the british isles lupus assessment group index (bilag) * active moderate to severe sle disease as demonstrated by sle disease activity index (sledai) total score * on stable sle treatment regimen, including mandatory corticosteroids and immunosuppressants or antimalarials exclusion criteria: * subjects who are breastfeeding, pregnant, or plan to become pregnant * subjects with active, severe sle disease activity which involves the renal system * subjects with active, severe, neuropsychiatric sle, defined as any neuropsychiatric element scoring bilag level a disease. * subjects with the evidence of an immunosuppressive state * subjects who, in the opinion of the investigator, are at a particularly high risk of significant infection * history of malignant cancer, except the following treated cancers: cervical carcinoma in situ, basal cell carcinoma, or dermatological squamous cell carcinoma. * subjects receiving any live vaccination within the 8 weeks prior to screening (visit 1). * subjects with history of infections, including but not limited to concurrent acute or chronic viral hepatitis b or c * subjects with substance abuse or dependence or other relevant concurrent medical condition * subjects with history of thromboembolic events within 1 year of screening visit. * subjects with significant hematologic abnormalities * subject has received treatment with other anti- b cell antibodies within 12 months prior to screening (visit 1) * subject use of oral anticoagulant (not including) nonsteroidal anti-inflammatory drugs (nsaids) within 12 weeks prior to screening (visit 1) * subject has previously participated in this study or has previously received epratuzumab treatment.

Keywords: lupus monoclonal antibody b-cell immunotherapy epratuzumab
compare the efficacy and safety of 1pc111 with pitavastatin and ezetimibe in patients with primary hypercholesterolemia or mixed dyslipidemia

Conditions: Primary Hypercholesterolemia; Mixed Dyslipidemias

Summary: the study is to evaluate whether the efficacy of 1pc111 is superior to pitavastatin and ezetimibe in patients with primary hypercholesterolemia or mixed dyslipidemia in the 12 week treatment period.


Eligibility criteria:
inclusion criteria: 1. primary hypercholesterolemia or mixed dyslipidemia 2. subject meeting all of the following diagnoses at baseline visit: * tg≦350 mg/dl * alt and ast≦ 2.5 times of upper limit of normal (uln) with no acute liver disease * creatine kinase (ck) concentration≦2 times of ul n * creatinine≦1.5 mg/dl 3. subject who is willing and able to provide inform ed consent exclusion criteria: 1. female who is or intends to be pregnant or breast feeding, or has childbearing potential but without effective contraception. 2. subject with documented hiv 3. subject with uncontrolled hypothyroidism according to the investigator's judgment 4. subject with unstable cardiovascular disease (cvd), including but not limited to congestive heart failure (chf) defined as new york heart association class iii or iv, unstable angina, unstable arrhythmia according to the investigator's judgment 5. subject with unstable hepatic or biliary disorders, including but not limited to acute hepatitis, acute exacerbation of chronic hepatitis, liver cirrhosis, liver cancer, jaundice , and chronic hepatitis b or c under antiviral therapy 6. subject with the following medical histories: * history of malignancy, exceptions made for the following malignancies: a)those determined to be cured or in remission for ≥ 5 years, b) curatively resected basal cell or squamous cell skin cancers, c) cervical cancer in situ, or resected colonic polyps * acute coronary syndrome with or without cardiac catheterization within the past 9 months * therapeutic cardiac catheterization (due to reasons other than acute coronary syndrome) within the past 6 months 7. any unstable comorbidities or clinical conditions , including laboratory abnormalities which could lead to unacceptable risk to subject or confound data interpretation , per investigatiors judgment 8. use any lipid lowering agent within 6 weeks prior to initiating the study treatment ( recheck this criterion at day 1) 9. use cyclosporine within 6 weeks prior to initiating the study treatment (recheck this criterion at day 1) 10. use any investigational product within 6 weeks prior to initiating the study treatment ( recheck this criterion at day 1)

Keywords: primary hypercholesterolemia mixed dyslipidemias
preliminary anti-tumour activity of mtor kinase inhibitor in advanced tumours

Conditions: Cancer; Advanced Solid Tumours; Lymphomas

Summary: to investigate the safety and tolerability of azd8055 intermittent dosing schedules when given orally to patients with advanced solid malignancies and lymphomas. two intermittent dosing schedules will be explored with increasing doses until a maximum tolerated dose is determined for each schedule.


Eligibility criteria:
inclusion criteria: * histological or cytological confirmation of an advanced solid malignant tumour or lymphoma which is refactory to standard therapies or for which no standard therapy exists, patients with measurable or non-measurable disease (according to recist criteria) * who performance status 0-2 * evidence of post-menopausal status or negative urine/serum pregnancy test for pre-menopausal female patients exclusion criteria: * patients with severe laboratory abnormalities for haematology, liver or renal function. also treatment with any haemopoietic growth factors are not allowed within two weeks from first dose of study drug. * any investigational agents or study drugs from a previous clinical study within 30 days, any other chemotherapy, immunotherapy or anticancer agents within 3 weeks of the first dose of study treatment * patients with severe cardiac condition of ischemia, impaired ventricular function and arrhythmias, evidence of severe or uncontrolled systemic or current unstable or uncompensated respiratory or cardiac conditions

Keywords: cancer advanced solid tumours lymphomas dose escalation preliminary anti-tumour activity tor kinase inhibitor oral administration intermittent dosing