Kornimate/medical-research-clean huggingface dataset:
single-cell map of immune and lymphoma cells in b-cell non-hodgkin's lymphoma

Conditions: Diffuse Large B-cell Lymphoma

Summary: this trial is a translational, prospective, open-label, monocentric research. the study will be conducted in a population of 60 patients with diffuse large b-cell lymphoma (dlbcl) for whom first-line treatment with r-chop is planned as part of their standard of care. simily program aims at identifying biomarkers and/or molecular signatures related to immuno-phenotypic and -genotypic characteristics of the tumor and immune microenvironment, at the time of diagnosis, during r-chop, and at 24 months or time of progression. each patient will be followed during 2 years.


Eligibility criteria:
inclusion criteria: 1. patient with histologically confirmed diffuse large b-cell lymphoma with a planned first line treatment by r-chop (treatment by r-chop should not have been initiated prior to inclusion in the study) 2. age 18 to 80 years at the time of study entry 3. archived initial diagnostic tumor specimen available 4. life expectancy ≥ 3months 5. ecog performance status 0-2 6. fdg-avid disease (for pet monitoring) 7. signed written informed consent 8. patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol 9. patient affiliated to a social health insurance in france exclusion criteria: 1. patient pregnant, or breast-feeding 2. any condition contraindicated with tumor / blood sampling procedures required by the protocol 3. central nervous system (cns) involvement 4. known history of positive test for hepatitis b virus or hepatitis c virus or immunodeficiency virus (hiv) or known acquired immunodeficiency syndrome (aids) 5. any current severe or uncontrolled disease, including, but not limited to ongoing or active infection and auto immune disorders 6. any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure 7. patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice) 8. current participation in any other therapeutic clinical study

Keywords: diffuse large b-cell lymphoma r-chop treatment biomarker single-cell sequencing
camellia cohort: a longitudinal study to understand sexual health and prevention among women in alabama

Conditions: Hiv; Sexually Transmitted Diseases

Summary: pre-exposure prophylaxis (prep) is an important biomedical human immunodeficiency virus (hiv) prevention tool and may particularly benefit black, cis and trans-gender women, who are at an increased risk for hiv and sexually transmitted infections (stis). the purpose of this study is to use a population-based approach to create a cohort of cis and trans-gender women at risk for future hiv acquisition to better understand the factors associated with the risk of stis and hiv diagnosis and predictors of prep use.

to better understand contextual factors among people who identify as women in alabama that predict sti/hiv infection and prep use, we will refine an existing evidence-based mobile health app (healthmpowerment or hmp) to optimally engage and retain a digital cohort of women at-risk for hiv infection (i.e. prior infection in the past 3 months with gonorrhea or syphilis). using a sampling strategy based on geospatial analysis of hiv-risk, we will enroll and follow our cohort longitudinally to assess factors associated with incident sti/hiv infection as well as utilization of prep through iterative self-collected sti/hiv testing and survey assessments.

Eligibility criteria:
inclusion criteria: * self identify as a cis-gender or trans-gender woman * age 18 - 89 * reported sti in past 3 months by the alabama department of public health (adph) * gonorrhea and syphilis negative * hiv negative at screening encounter * live in alabama * have access to a private smart phone exclusion criteria: * live outside of alabama * positive diagnosis for hiv, gonorrhea, or syphilis

Keywords: hiv prevention education sti prevention education pre-exposure prophylaxis (prep)
tailored messaging for crc screening

Conditions: Colorectal Cancer

Summary: this is a randomized controlled trial to to determine whether direct, tailored messaging to patients prior to scheduling colonoscopy will increase patient adherence to provider recommendation for screening colonoscopy.

the proposed study is a prospective, randomized trial. all eligible subjects (patients identified to be contacted to schedule screening colonoscopy) will be randomized to one of three study arms: usual scheduling process (control), a generic message arm, or a tailored message arm. patients in the "tailored message" arm will receive a telephone call and be asked a series of questions that will be used to assign patients to one of four messaging cohorts. after these questions have been answered, the patient will then receive a tailored message corresponding to his or her respective messaging cohort, encouraging them to schedule a colonoscopy with a directed script. in the "generic message" arm, patients will receive a telephone call and be asked to answer the same series of questions as the "tailored message" group, then receive a single, standard script encouraging them to schedule a colonoscopy.

Eligibility criteria:
inclusion criteria: 1. university of pennsylvania health system (uphs) patients with an active order for screening or surveillance colonoscopy without an existing colonoscopy appointment 2. 50-75 years of age 3. due for crc screening or surveillance (defined as no evidence of: colonoscopy in the past 5 years, fecal immunochemical testing in the past 12 months, flexible sigmoidoscopy or ct colonography in the past 5 years, stool dna test or cologuard in the last 3 years) exclusion criteria: 1. age \ 75 2. pregnant woman 3. evidence of prior colonoscopy in the past 5 years, fecal immunochemical testing in the past 12 months, flexible sigmoidoscopy or ct colonography in the past 5 years, fecal dna test or cologuard in the last 3 years 4. history of colorectal cancer 5. history of inflammatory bowel disease (crohn's disease or ulcerative colitis) 6. history of colon surgery or resection 7. history of symptoms concerning for colorectal cancer, such as lower gi bleeding, within the past 6 months 8. family history of a hereditary colorectal cancer syndrome, such as familial adenomatous polyposis (fap) or hereditary non-polyposis colon cancer (hnpcc) 9. current serious medical condition with estimated life expectancy of less than 6 months, such as incurable cancer, end-stage congestive heart failure, decompensated cirrhosis, end stage renal disease, etc. 10. dementia 11. does not speak english 12. no telephone number listed in electronic medical record 13. has any other condition that, in the opinion of the investigator, excludes the patient from participating in this study

Keywords: colorectal cancer screening
dose-escalation study of quarfloxin in patients with advanced solid tumors or lymphomas

Conditions: Advanced Solid Tumors; Lymphoma

Summary: this phase 1 study of quarfloxin (cx-3543) is designed to test the safety, tolerability, and highest safe dose of this drug when administered intravenously weekly for three weeks of a four week cycle in patients with advanced solid tumors.

quarfloxin is a first-in-class small-molecule targeted cancer therapeutic derived from the validated fluoroquinolone class of drugs. quarfloxin was rationally designed to target a g-quadruplex (qplx) dna structure and disrupt protein-dna interactions essential to cancer cells. the qplx targeted by quarfloxin forms within ribosomal dna (rdna) and the qplx is bound by the nucleolin protein.

Eligibility criteria:
inclusion criteria: * patients with histologically confirmed solid tumors or lymphomas. * tumor progression after receiving standard/approved chemotherapy or where there is no approved therapy. * one or more tumors measurable on radiograph or ct scan, or evaluable disease (e.g., malignant ascites). * karnofsky performance status of greater than or equal to 70. * life expectancy of at least 3 months. * age at least 18 years. * patients must have central iv access, or agree to the insertion of a central iv line. * normal oxygen saturation by pulse oximetry on room air * a negative pregnancy test (if female). * acceptable liver function as evaluated by laboratory results * acceptable renal function as evaluated by laboratory results * acceptable hematologic status as evaluated by laboratory results * no clinically significant urinalysis abnormalities * acceptable coagulation status as evaluated by laboratory results * fertile men and women must use effective contraceptive methods during the study. exclusion criteria: * seizure disorders requiring anticonvulsant therapy. * known brain metastases (unless previously treated and well controlled for a period of greater than or equal to 3 months). * severe chronic obstructive pulmonary disease with hypoxemia, or an uncorrectable pulmonary compromise. * major surgery, other than diagnostic surgery, within 4 weeks prior to the first dose of test drug. * active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy. * pregnant or nursing women. * treatment with radiation therapy, surgery, chemotherapy, or investigational therapy within one month prior to study entry (6 weeks for nitrosoureas or mitomycin c). * unwillingness or inability to comply with procedures required in this protocol. * known infection with hiv, hepatitis b, or hepatitis c. * clinically significant bleeding event within the last 3 months, unrelated to trauma, or underlying condition that would be expected to result in a bleeding diathesis. * patients who are currently receiving any other investigational agent. * patients who have exhibited allergic reactions to a similar structural compound (e.g., fluoroquinolones, biological agent or formulation.

Keywords: solid tumors lymphoma g-quadruplex
strategy of surgical resection with adjuvant therapy for iiia nsclc and n2 disease only in subaortic or paraaortic level

Conditions: Lung Cancer; Cancer of Lymph Node; Effects of Chemotherapy; Surgery

Summary: the purpose of this study is to identify the treatment outcomes of surgical resection with sequential adjuvant chemotherapy and radiotherapy in patients with stage iiia non-small cell lung cancer and n2 disease at only the sub- or para-aortic level.

stage iiia non-small cell lung cancer (nsclc) is a very heterogeneous disease and current treatment guidelines recommend concurrent chemoradiation therapy or combined neoadjuvant chemotherapy, surgical resection, and sequential adjuvant therapy. when incidental n2 disease is found despite thorough preoperative staging, adjuvant platinum-based chemotherapy with or without adjuvant radiotherapy is recommended. although guidelines suggest preoperative mediastinal staging with endobronchial ultrasound-guided transbronchial needle aspiration (ebus-tbna), this method does not allow approach of the sub- or para-aortic lymph nodes. therefore, patients with suspected stage iiia nsclc and n2 disease only at the sub- or para-aortic level should undergo several processes if combined neoadjuvant chemotherapy and surgical resection is planned. first, video-assisted thoracoscopic surgery (vats) should be performed to verify whether the sub- or para-aortic lymph nodes are involved. if a frozen-section biopsy reveals no malignant tumor involvement in the sub- and para-aortic lymph nodes, the affected lung can be resected. if there is sub- or para-aortic lymph node involvement, further neoadjuvant chemotherapy is required before surgical resection and adjuvant therapy. studies have shown that stage iiia nsclc with only sub- or para-aortic lymph node involvement has better outcomes than other stage iiia nsclc. moreover, the five-year survival of patients with stage iiia nsclc with only sub- or para-aortic lymph node involvement is similar to that with stage ii nsclc. however, those studies were retrospective with relatively small sample sizes. therefore, we evaluated the outcomes of combined surgical resection with adjuvant chemotherapy and radiotherapy in patients with stage iiia nsclc and n2 disease at only the sub- or para-aortic level.

Eligibility criteria:
inclusion criteria: * patients with stage iiia non-small cell lung cancer and suspicious of n2 disease only in the subaortic or paraaortic level, or both on chest ct or pet scan exclusion criteria: * patients whose subaortic or paraaortic lymph nodes were revealed as negative by mediastinal lymph node dissection * patients whose mediastinal lymph nodes other than subaortic or paraaortic level were confirmed as malignant node by mediastinal lymph node dissection
skin preparation for elective foot and ankle surgery

Conditions: Microbial Colonization; Foot and Ankle Disorders

Summary: surgical site infections (ssis) make about 31% of all nosocomial infections and they are the most common hospital-acquired infection. for foot and ankle elective interventions, ssi rate is reported between 0.4% and 3.6%. this study will investigate the effectiveness of skin cleaning with isopropyl alcohol and scrubbing with chlorhexidine soap before standard skin preparation in reducing microbial load and surgical site infections for elective foot and ankle surgeries. current standard of care includes skin preparation with iodine or chlorhexidine solution prior to sterile draping and the start of surgery. standard of care will be applied to all patients. the use of an additional "pre-scrub" with isopropyl alcohol and scrubbing with chlorhexidine soap will be applied to the experimental group. the control group will receive only the standard of care skin preparation with iodine or chlorhexidine solution prior to draping.


Eligibility criteria:
inclusion criteria: * patients undergoing elective foot and ankle surgeries * age over 18 exclusion criteria: * trauma as the indication for surgery * open injuries * non-elective procedures * amputations * prior surgical site infection through the planned incision * pregnancy. all potential participants of child-bearing potential follow the standard pre-operative protocol to ensure they are not in pregnant status prior to soc surgical procedure.
international prospective registry on local treatment approaches in mls

Conditions: Myxoid Liposarcoma

Summary: to prospectively study commonly used local treatment approaches in myxoid liposarcoma (mls)

in order to confirm the promising results of the 36 gy dose level in the doremy trial (nct02106312) and to compare outcome with other local treatment approaches.

Eligibility criteria:
inclusion criteria: * age \> 18 years * biopsy proven mls, including the reciprocal chromosomal translocation t(12;16)(q13;p11) * ecog ps 0-2 * written informed consent to share coded information in this international registry exclusion criteria: * prior radiotherapy to the target area * pregnancy
trial of fk614 in type 2 diabetics inadequately controlled on a sulfonylurea

Conditions: Diabetes Mellitus

Summary: the purpose of the study is to assess the safety and efficacy of fk614 in type 2 diabetic subjects receiving sulfonylurea (su) monotherapy.

this is a prospective randomized, double-blind, placebo controlled, parallel group, phase 2 study. subjects meeting selection criteria will be randomly assigned to receive 12 weeks twice daily (bid) dosing with fk614 or placebo. enrollment for this study will be approximately 200 patients.

Eligibility criteria:
inclusion criteria * has history of type 2 diabetes mellitus for at least 1 year * has been taking current sulfonylurea (su) for at least 3 months. subjects currently taking metformin may be eligible to be switched. * has not received any oral antidiabetic medication other than an su or taken regularly prescribed insulin for at least 3 months exclusion criteria * has type 1 diabetes mellitus * has uncontrolled hypertension, i.e., systolic bp \>170 or diastolic bp \> 95 mm hg. * history of congestive heart failure
efficacy and safety of subcutaneous administration of tev-48125 for the preventive treatment of episodic migraine

Conditions: Migraine

Summary: to evaluate the efficacy and safety of subcutaneous (sc) administration of tev-48125 (monthly tev-48125 225 mg and tev-48125 675 mg once over a period of 3 months) compared with placebo for preventive treatment in episodic migraine patients


Eligibility criteria:
inclusion criteria: * patient has a history of migraine (according to the international classification of headache disorders, third edition \[beta version\] criteria) or clinical judgment suggests a migraine diagnosis * patient fulfills the criteria for episodic migraine in baseline information collected during the 28 day screening period * not using preventive migraine medications for migraine or other medical conditions or using no more than 1 preventive migraine medication for migraine or other medical conditions if the dose and regimen have been stable for at least 2 months prior to giving informed consent. * patient demonstrates compliance with the electronic headache diary during the screening period by entry of headache data on a minimum of 24 of 28 days and the entered data is judged appropriate by the investigator. exclusion criteria: patients who have previously failed (lack of efficacy) 2 or more of the clusters of the medications for treatment of migraine after use for at least 3 months at accepted migraine therapeutic doses - hematological, cardiac, renal, endocrine, pulmonary, gastrointestinal, genitourinary, neurologic, hepatic, or ocular disease considered clinically significant in the judgment of the investigator
a study of txn10128 in subjects with solid tumors

Conditions: Locally Advanced (Unresectable) or Metastatic Solid Tumors

Summary: this is a phase i clinical trial to primarily evaluate the safety, tolerability, and addtionally assess pharmacokinetics, pharmacodynamics, and antitumor activity of investigational product, txn10128. the target subjects will be consisted of patients with locally advanced (unresectable) or metastatic soild tumors. this study includes a dose-escalation part and a dose-expansion part, and a txn10128 monotherapy part and a txn10128 + irinotecan or paclitaxel combination therapy part.

this study includes a dose-escalation part and a dose-expansion part, and a txn10128 monotherapy part and a txn10128 + irinotecan or paclitaxel combination therapy part. the study includes dose-escalation and dose-expansion parts across three cohorts: txn10128 monotherapy (cohorts a) txn10128 + irinotecan (cohorts b) and txn10128+ paclitaxel (cohorts c).

Eligibility criteria:
inclusion criteria: * male or female subjects ≥19 years of age at the time of informed consent. * histologically and/or cytologically confirmed any progressive, locally advanced (unresectable), or metastatic solid tumors that have relapsed or are refractory following the last line of treatment and for which prior standard therapy has been ineffective, or standard therapy does not exist or is not considered appropriate. * ecog performance status of 0 or 1. * life expectancy of at least 12 weeks. exclusion criteria: * has leptomeningeal disease. * experienced a grade ≥3 immune-related adverse events (irae) with prior immunotherapy with the exception of non-clinically significant laboratory abnormalities. * prior organ transplantation. * known positive human immunodeficiency virus (hiv) infection.

Keywords: enpp1 enpp1 inhibitor txn10128 txinnobio txinno bioscience innate immune sting pathway
effects of docosahexaenoic acid (dha) on cardiovascular disease on diabetic patients

Conditions: Type 2 Diabetes

Summary: aim: to determine the effects of dha supplementation: * on the platelet function through their aggregation and the pathway of arachidonic acid metabolism * on redox status on cells and plasma * on inflammation in 16 type 2 diabetic patients in a cross-over study comparing dha (400 mg/day for 2 weeks) vs sunflower oil (placebo). each period is separated by a wash-out period of 6 to 9 weeks.


Eligibility criteria:
inclusion criteria: * woman * type 2 diabetes * menopausal or aged between 55 and 75 years old * recent hba1c between 6.5-10% * oral anti-diabetic drugs or insulin therapy * hypertension or antihypertensive drug exclusion criteria: * tobacco * excessive drinking * post-menopausal hormonal treatment * treatment by acetylsalicylic acid, clopidogrel, gliclazide, ticlopidine, nsaid * secondary cardiovascular prevention * antioxidant using * fish intake \>2 times a week * anemia \<10g/l * thrombopenia \<110g/l * creatinine clearance \ 1g/l

Keywords: dha supplementation type 2 diabetic patient platelet function
monotherapy with rapamycin in long-standing type 1 diabetes

Conditions: Diabetes Mellitus, Type 1

Summary: this study is a phase 2, single-center, prospective, randomized, double-blind, placebo-controlled, 3-arm parallel group (1:1:1) intervention trial to determine the efficacy of 4 weeks rapamycin treatment and 4 weeks rapamycin treatment plus 3 months vildagliptin treatment versus placebo in increasing endogenous insulin production and correcting glycemic lability. it will involve 60 patients with long standing type 1 diabetes (t1d). patients will receive for one month placebo (group 1), rapamycin plus placebo (group 2), or rapamycin plus vildagliptin (group 3). rapamycin will be administered at an initial dose 0.2 mg/kg orally on day 0 followed by 0.1 mg/kg/die (target trough levels: 8-10 ng/ml). vildagliptin will be administered at a dose of 50 mg x2/die starting from day 0. after 4 weeks of treatment (period a), patients will discontinue rapamycin or relevant placebo treatment, but continue vildagliptin or placebo for a further 8 weeks and be monitored over this period (period b).


Eligibility criteria:
inclusion criteria: * male or female aged \>18 years, inclusive * clinical history compatible with t1d with onset of disease at \< 40 years of age, insulin dependence for ≥ 5 years at the time of enrolment * c-peptide concentrations under the threshold of preserved beta cell function: fasting c peptide \<0.23 ng/ml * detectable fasting proinsulin concentrations (\>0.5 pmol/l) * ability to provide written informed consent * mentally stable and able to comply with the protocol procedures for the duration of the study, including scheduled follow-up visits and examinations exclusion criteria: * body mass index (bmi) \>30 kg/m2 or patient with body weight ≤40kg; * insulin requirement \>1.0 iu/kg/day or \<10 u/day; * hba1c \>11% (normal value: 3.5-6.0%) at the time of enrolment * estimated glomerular filtration rate \<60 ml/min/1.73m2 calculated using the subject's measured serum creatinine and the modification of diet in renal disease \[mdrd\] study estimation formula) * presence or history of macroalbuminuria (\>300mg/g creatinine) * for female subjects: positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study and 4 months after discontinuation of treatment * active infection including hepatitis b, hepatitis c, hiv, or tuberculosis (tb) as determined by a positive skin test or clinical presentation, or under treatment for suspected tb * any history of malignancy except for completely resected squamous or basal cell carcinoma of the skin * lymphopenia (\<1,000/μl), neutropenia (\<1,500/μl), or thrombocytopenia (platelets \<100,000/μl). * severe unremitting diarrhea, vomiting or other gastrointestinal disorders potentially interfering with the ability to absorb oral medications * any medical condition that will interfere with safe participation in the trial; * any immunosuppressive treatment at the time of enrollment. * allergy to active ingredients or to any of excipients