Kornimate/medical-research-clean huggingface dataset:
open label, dose escalation trial of oral eg5 kinesin-spindle inhibitor 4sc-205 in patients with advanced malignancies

Conditions: Advanced and Incurable Solid Tumors; Malignant Lymphomas

Summary: the purpose of the study is to investigate safety and tolerability of repeated ascending oral doses of 4sc-205 in patients with advanced and incurable solid tumors or malignant lymphomas.


Eligibility criteria:
main inclusion criteria: * one or more evaluable target lesion according to recist (by ct-scan, mri or calipers), of which at least one evaluable target lesion (proven by ct or mri) has to be located in the lung. * progressive disease as defined by new or progressive lesions on ct-scan, mri, bone scan or by increase of psa. * histologically or cytologically documented diagnosis of primary or metastatic solid tumors or malignant lymphomas refractory to prior standard therapy or for which no standard therapy exists. entry will include, but is not limited to patients with prostate and breast cancer refractory to hormone treatment, ovarian cancer, head and neck cancer, non-small cell lung cancer, bladder cancer, colorectal cancer, kidney cancer, malignant melanoma or malignant lymphoma. patients who have refused standard therapies are also eligible. * ecog performance status 0-2. * acceptable liver, renal and bone marrow function. main exclusion criteria: * prior treatment with other eg5 inhibitors. * antineoplastic therapy including chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the last 2 weeks or a longer period depending on the defined characteristics of the agents used (e.g. 6 weeks for mitomycin c or nitrosourea). patients must have recovered from any treatment-related toxicity (except for alopecia, fatigue and grade 1 neurotoxicity) prior to registration. * patients with a history of other malignancies unless having undergone definitive treatment more than 5 years prior to entry into the study and without evidence of recurrent malignant disease, excluding patients with basal cell carcinoma of the skin; superficial carcinoma of the bladder; carcinoma of the prostate with a current psa \< 0.1 ng/ml; or cervical intraepithelial neoplasia. * patients with a history of significant cardiovascular, neurological, endocrine, gastrointestinal, respiratory or inflammatory illness. * patients with a history of, who were treated for, or who are suspected of having, hepatitis b, hepatitis c or hiv.

Keywords: 4sc-205 solid tumors lymphomas phase i
comparison of different methods of capture of circulating tumour cells (ctc) in patients with metastatic breast or prostate cancer

Conditions: Metastatic Breast Cancer; Metastatic Prostate Cancer

Summary: this trial is a pilot, prospective, single-center study conducted in a population of patients with metastatic breast cancer (whatever the immunohistochemical subtype) or metastatic prostate cancer. the aim of this exploratory study is to compare the sensitivity of three different techniques (cellsearch®, parsortix® and smartcatch®) in detecting circulating tumor cells (ctcs). after the patient's agreement, and before starting anti-tumor treatment, a blood sample will be taken using the 3 different ctc detection techniques. each patient will participate in the study for one day. a total of 36 evaluable patients (18 patients with metastatic breast cancer and 18 patients with metastatic prostate cancer) will be included in this interventional study.


Eligibility criteria:
inclusion criteria: 1. patient with breast cancer (whatever the immunohistochemical subtype: triple-negative, rh+/her2-negative or her2-positive) or prostate cancer, multi-metastatic, eligible for a new line of treatment. 2. patient not yet initiated on a new specific treatment for breast or prostate cancer at inclusion. 3. age ≥ 18 years and who ≤ 2 4. patient affiliated to social security scheme in france. 5. patient having signed informed consent prior to inclusion in the study and prior to any study-specific procedures. exclusion criteria: 1. associated pathology(ies) likely to prevent the study procedure from running smoothly 2. any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and/or procedures stipulated in the study protocol. 3. patient deprived of liberty or under legal protection (guardianship, legal protection) 4. patient who has had another solid tumor (excluding carcinoma in situ of the breast or cervix) within 5 years.

Keywords: circulating tumor cell metastatic prostate cancer metastatic breast cancer cellsearch® parsortix® smartcatch®
monroe county inflammatory bowel disease (ibd) registry

Conditions: Inflammatory Bowel Disease; Crohn's Disease; Ulcerative Colitis

Summary: this phase is to register all subjects in monroe county, new york with inflammatory bowel disease (ibd) not already included to update the database for years 1990-2003. this will give us a truly population based study which will add to our knowledge of ibd epidemiology, allowing us to compare our rates with the rest of the world. we will be able to provide accurate incidence data from 1980 to 2000, and point prevalence from 12/31/2000. it will have special significance because of the relatively stable monroe county population prior to 2000 (population in 1970=711,917; population in 2000 = 735,343).


Eligibility criteria:
inclusion criteria: * patients with ibd who sign consent from 1995-2001 exclusion criteria: * patients without ibd

Keywords: crohn's disease ulcerative colitis ibd inflammatory bowel disease in monroe county, ny
laparoscopic surgery of rectal cancer and ileostomy

Conditions: Ileostomy - Stoma; Ileostomy; Complications; Leakage, Anastomotic

Summary: elective diverting ileostomy may reduce consequences of anastomotic failure in laparoscopic tme. aiming to evaluate the effectiveness of elective diverting ileostomy, its impact on the incidence and clinical behavior of anastomotic leakage and the complications related to its presence and take down were analyzed.

from a prospective collected database, data regarding patients who underwent to laparoscopic tme, with (group 1) or without (group 2) elective diverting ileostomy for rectal cancer from 2012 to 2017 at university campus bio-medico di roma, have been retrospectively analyzed.

Eligibility criteria:
inclusion criteria: * adult patients (aged 18 years and over) * patients submitted to elective anterior rectal resection exclusion criteria: * chronic use of immunosuppressant agents * urgent surgery
the effect of a brief online behavioral activation intervention

Conditions: Depression

Summary: depression is a worldwide phenomena that has a severe personal, social and societal impact. one such impact is an over $200 billion worldwide economic cost. while many treatments exist for depression, many individuals may not receive the support that they need for reasons such as stigma, financial restraints, or limited access to therapists. as such, it is important to assess the efficacy of brief online treatments as an alternative to full length, in-person treatments. a series of studies looking at a brief behavioral activation for depression treatment has shown that participants have reported temporarily improved mood, confidence, motivation and reduced depressive symptoms. it is important to test this treatment in multiple groups of people to acquire additional information regarding brief online interventions. this study seeks to collect participants from online social media sources and compare results to historical data that were collected from a prior research study which used amazon mechanical turk as a recruitment source.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * united states resident exclusion criteria: * non-us resident * younger than 18 years old
the cardioprotective effect of intralipid in decreasing the ischemic insults during off-pump coronary artery revascularization

Conditions: Anesthesia

Summary: the aim of the study is to assess the effect of intralipid as regard efficiency in decreasing myocardial ischemia , given during preconditioning in off pump coronary artery revascularization


Eligibility criteria:
inclusion criteria: * patients between 40 to 75 undergoing off bump cabg surgery exclusion criteria: * emergency surgery * ejection fraction less than 50% * redo procedures * history of allergy to peanuts
homologous recombination repair pathway gene mutation spectrum in chinese breast cancer patients

Conditions: Breast Cancer

Summary: the goal of this clinical trial is to learn about the mutation spectrum of homologous recombination repair pathway genes and its instructive significance in the treatment of chinese breast cancer patients.

the main questions it aims to answer are: 1. what is the mutation spectrum of homologous recombination repair pathway genes in chinese breast cancer patients? 2. does homologous recombination repair pathway gene mutation have an impact on patient outcome (breast cancer recurrence, neoadjuvant chemotherapy efficacy, treatment decisions, etc.) ? there is no intervention on participants, but all participants will be given regular follow-up post surgery according to asco guidelines.

Eligibility criteria:
inclusion criteria: 1. pathology-confirmed breast cancer patients who meet at least one of the criteria below: * triple-negative breast cancer * age ≤ 50 years * male breast cancer * with personal or family history of malignancy: breast cancer, ovarian cancer, prostate cancer, pancreatic cancer, other malignancies * her-2 negative recurrent or metastatic breast cancer * her-2 negative high-risk breast cancer: a: neoadjuvant phase: non-pathological complete response for triple-negative breast cancer; non-pathological complete response and cps+eg score ≥ 3 for hormone receptor positive breast cancer b: adjuvant phase: ≥ pt2 or ≥ pn1 for triple-negative breast cancer; ≥ 4 lymph node metastasis for hormone receptor positive breast cancer 2. having been or intended to be tested for germline and (or) somatic homologous recombination repair gene mutations 3. consent to providing medical charts and homologous recombination repair gene testing results, and being cooperative for long-term follow-up exclusion criteria: 1. homologous recombination repair gene testing results unavailable 2. other factors deemed by the investigators that may sabotage the study

Keywords: homologous recombination repair pathway outcome mutation
masitinib plus docetaxel in metastatic castration-resistant prostate cancer

Conditions: Metastatic Castrate Resistant Prostate Cancer

Summary: study of masitinib plus docetaxel as first-line chemotherapy in men with metastatic castration-resistant prostate cancer.

the objective of this study is to evaluate the efficacy and safety of masitinib in combination with docetaxel and prednisone with respect to placebo in combination with docetaxel and prednisone in the treatment of first line metastatic castrate resistant prostate cancer (mcrpc). approximately 580 patients will be randomized in 2 groups with a ratio 1:1. the primary outcome measure is progression free survival. masitinib is a selective tyrosine kinase inhibitor that is thought to promote survival via modulation of immunostimulation-mediated anticancer effects and modulation of the tumor microenvironment.

Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed metastatic castrate resistant prostate cancer (medical or surgical castration: androgens deprivation by gnhr agonist or antagonist or patient with surgical castration; hormonal castration confirmed biologically (testosterone \< 0.5ng/ml) with one of the following criteria: * pre-treated with abiraterone with documented progressive disease, or * indicated for initiating docetaxel treatment (e.g., widespread visceral disease or rapidly progressive disease). 2. patient with evidence of progressive metastatic disease as assessed according to the prostate cancer clinical trials working group 2 (pcwg2) recommendations. 3. patient with adequate organ function as per protocol exclusion criteria: 1. patient who has been previously treated with chemotherapy.

Keywords: metastatic castration-resistant prostate cancer metastatic hormone-resistant prostate cancer tyrosine kinase inhibitor mcrpc mhrpc
resveratrol as a preventive treatment of ohss

Conditions: Infertility

Summary: evaluation of resveratrol treatment oh ovarian hyperstimulation syndrome in egg donors

randomized clinical trial to evaluate the role of resveratrol in preventing ovarian hyperstimulation syndrome by reducing vgef expression and estradiol production, imporving hemoconcentration and symptomathology of this condition

Eligibility criteria:
inclusion criteria: * number of follicles greater than 12 mm after ovarian stimulation * number of retrieved oocytes greater than 21 exclusion criteria: * \>35 years-old * pcos * endometriosis * systemic pathology * positive serologies for hbv, hbc and hiv * abnormal karyotype

Keywords: resveratrol ohss pcos
a study of symptom improvement of ulcerative colitis after an induction dose of ustekinumab in japanese clinical practice

Conditions: Ulcerative Colitis

Summary: the purpose of this study is to describe the initial response to ustekinumab induction treatment for ulcerative colitis (uc) in japan.


Eligibility criteria:
inclusion criteria: * must have a confirmed diagnosis of ulcerative colitis (uc) in accordance with local practice * has a current uc severity that is judged by the treating physician to be moderate to severe (being a partial mayo score of 5 to 9, inclusive) * a decision has been made by the treating physician and the participant within routine clinical practice to commence treatment with ustekinumab, having been deemed to have an inadequate response to, or intolerant to, previous uc therapy * must sign an informed consent form (icf) allowing data collection and source data verification in accordance with local requirements. if the participant is 16 to 19, informed consent might be obtained from each study participant according to the regulation of institution/hospital and their legally acceptable representative must sign an icf * must be able to read, understand, and complete participant-reported outcome instruments, and intend to cooperate with completion of participant-reported outcome instruments using smartphone/tablet exclusion criteria: * has ever previously received ustekinumab (including clinical trial use) * are currently receiving, or have received within the past 3 months, systemic treatment with a biologic therapy for any other indication (example crohn's disease, psoriasis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis) * received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 3 months before the start of the study or the first data collection time point * currently enrolled in an interventional study or another janssen-sponsored observational study (including post-marketing surveillance) * based on physician judgement has i) severe extensive colitis and is at imminent risk of colectomy or ii) a stoma or history of a fistula or iii) previously had extensive colonic resection (example, less than 30 centimeter (cm) of colon remaining) or iv) current fulminant colitis or v) currently hospitalized for worsening of uc-related symptoms (not excluded if the reason for hospitalization is first dose of ustekinumab)
umbrella trial of adjuvant therapy in completely resected high-risk stage ia-ib nsclc: focus on driver mutations

Conditions: Non-Small Cell Lung Cancer

Summary: this study explores how adjuvant therapy affects survival in completely resected high-risk stage ia-ib nsclc patients with different driver gene mutations.

this study aims to evaluate whether tailored, targeted therapy or immunotherapy can effectively prevent cancer recurrence in patients with early-stage (stage ia-ib) non-small cell lung cancer (nsclc) who have undergone complete surgical resection but are at high risk of recurrence. based on each patient's specific driver gene mutation status (e.g., egfr or alk/ros1) or wild-type status, participants will receive either targeted therapy or immunotherapy compared to routine follow-up (observation). the goal is to see if these approaches can improve disease-free survival and potentially reduce the risk of lung cancer recurrence.

Eligibility criteria:
inclusion criteria: * age 18-75 years and able to provide written informed consent. * primary non-squamous nsclc confirmed by pathology, with no brain metastases. * complete r0 surgical resection (lobectomy, segmentectomy, or pneumonectomy) of stage ia or ib nsclc (ajcc 8th edition). * high-risk disease (one or more): low differentiation, solid/micropapillary/complex glandular patterns, vascular invasion, visceral pleural invasion, alveolar space spread, or intermediate/high risk on 14-gene test. * documented driver gene status (egfr mutation, alk/ros1 fusion, or wild-type) via postoperative tumor sample. * ecog performance status 0 or 1, with stable condition over the last two weeks. * surgery within 4-10 weeks before starting treatment, with full recovery. * adequate organ function as per protocol-defined labs. * negative pregnancy test (if applicable) and use of effective contraception during and 3 months after treatment. exclusion criteria: * evidence of unresectable/metastatic nsclc, incomplete resection (r1/r2), or wedge resection only. * prior systemic therapy (e.g., chemotherapy, targeted therapy, immunotherapy) for the current nsclc. * major surgery (excluding lung cancer surgery) within 3 weeks before first study dose. * planned concurrent anti-cancer therapy (chemo, radiotherapy, or targeted therapy) during the study. * clinically significant cardiac disorders (e.g., poorly controlled hypertension, recent mi or stroke, prolonged qtc). * history or suspicion of interstitial lung disease requiring treatment. * active or uncontrolled infection (e.g., hepatitis b with detectable hbv dna, hepatitis c, hiv, active tb). * severe gi conditions impairing drug absorption (e.g., crohn's, ulcerative colitis). * use of strong cyp3a inducers/inhibitors within 1 week or ongoing need for warfarin. * participation in another interventional trial within 4 weeks or receipt of a live vaccine within 180 days. * any condition that may compromise adherence or safety, per investigator judgment.
efficacy of hipec in patients with colorectal cancer at high risk of peritoneal carcinomatosis

Conditions: Colorectal Cancer

Summary: the purpose of this study is to determine the efficacy of adjuvant hipec with mitomycin c after colectomy in the treatment of colorectal cancer patients at high risk of peritoneal carcinomatosis.

the effectiveness of cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (hipec) have been addressed for the treatment of peritoneal carcinomatosis in selected patients. however, prophylactic hipec in colorectal cancer patients at high risk of metachronous peritoneal metastases remained controversial. in this study, patients with colorectal cancer ct4n0-2m0(ajcc/uicc staging system 8th edition) and planed to undergo intentionally colectomy (laparotomy, laparoscopy，or robotic ) are randomized into hipec group and control group. in hipec group, closed hipec is performed with mitomycin c(30mg/m2) at 43 °c for 90 minutes, simultaneously or within 2 days after colectomy and followed by systemic chemotherapy. for the patients in the control group, systemic chemotherapy were administered after colectomy. the primary endpoint is peritoneal recurrence-free survival (prfs) rate. secondary end points include overall survival (os) rate, disease free survival (dfs) rate, liver metastatic rate, toxic effects, quality of life scores. all efficacy analyses are conducted in the intention-to-treat population, per-protocol population and pt4 subgroups due to pathologic tumor invasion can not be acquired before hipec. safety analysis include only patients who receive their randomly assigned treatment.

Eligibility criteria:
inclusion criteria: * age between 18 and 70 years * nonpregnant or breast-feeding women * ecog status 0-1 * colorectal adenocarcinoma or mucinous adenocarcinoma; * intraoperative confirmed ct4n0-2m0 colorectal cancer (visual determination - according to ajcc 8th edition) without previous anti-cancer treatment and r0 resection could be achieved * laboratory tests within 2 weeks before randomization：neutrophil ≥ 2.0 /mm3, , platelets ≥ 100,000/mm3, hemoglobin≥90g/l, alanine transaminase (alt) and aspartate aminotransferase (ast) ≤ 2.5 ×uln), total bilirubin(tbil)≤ 1.5 × uln, serum creatinine ≤ 1.5 ×uln * written informed consent exclusion criteria: * rectal cancer below peritoneal reflection * concurrent with or have other cancer within the past 5 years ( except for skin basal cell carcinoma, or cervical carcinoma in situ, who have received radical treatment) * severe abdominal infection or extensive fibrosis of peritoneal cavity that lead to impossible separation * surgical procedures conversion(from robotic or laparoscopic surgery to laparotomy) or emergency surgery due to perforation or obstruction * existence of distance metastasis during surgery (m1) or can not achieve r0 resection * contraindiction of mitomycin c(chickenpox or shingles) * poorly controlled respiratory or cardiac disease, severe hepatic or renal dysfunction,drug abuse or uncontrolled mental disease

Keywords: colorectal cancer colectomy hyperthermic intraperitoneal chemotherapy peritoneal carcinomatosis
evaluation of therapeutic adherence to inciting spirometry in sickle cell patients

Conditions: Sickle Cell Disease

Summary: sickle cell disease is one of the most common genetic diseases in the world. (1) it is characterized by the production of abnormal hemoglobin mainly responsible for vaso-occlusive clinical manifestations and chronic hemolysis with anemia. (2) it is therefore a chronic disease with major acute complications, such as acute chest syndrome. the treatment for this syndrome will be based on oxygenation, hydration and analgesia. at the physiotherapy level, we will have an action on the prevention and treatment of the syndrome by incentive spirometry. (3,4) in fact, it is currently the only physiotherapy treatment that has proven its effectiveness and is recommended for sickle cell patients. (3) as part of prevention, it is recommended to prescribe incentive spirometry during vaso-occlusive crisis. it has been shown to reduce the risk of atelectasis and significantly limit the risk of developing acs. (5) in treatment, it makes it possible to regain normal chest amplification and therefore to allow ventilation of unventilated areas. (3.4) however, in order to increase therapeutic efficacy, patient compliance is essential. adherence to treatment is a major problem in chronic diseases. currently, it is estimated that 80% of patients with chronic conditions do not sufficiently follow their therapy, which limits the optimization of benefits. (6) this is the case in sickle cell patients, especially with hydroxyurea which is their disease-modifying treatment. lack of adherence is the most common cause of primary failure of this treatment. during various treatments, we noticed the patients' lack of compliance with spirometry. indeed, we explained to the patient how to do the incentive spirometry, so that he could practice it several times a day as recommended. when we returned the next day, or after a weekend, most of the time the patients had little or no observance. so i wanted to know if this concerns a majority of patients with sickle cell disease. indeed, it appears important to assess compliance in these patients in order to improve the effectiveness of treatment and reduce the risk of acs.


Eligibility criteria:
inclusion criteria: * patients with sickle cell disease, * major * no opposition for participation in the protocol exclusion criteria: * patients unable to answer the questionnaire due to linguistic or other problems * patients under guardianship or curatorship

Keywords: acute chest syndrome, incentive spirometry, compliance