Kornimate/medical-research-clean huggingface dataset:
efficacy , safety of treatment r nimp for relapsed aggressive lymphomas

Conditions: Diffuse Large B-Cell Lymphoma

Summary: the primary objective of the protocol is to estimate the complete response rate of three courses of the association of rituximab, navelbine, ifosfamide, mitoxantrone, and prednisone in relapsed aggressive non hodgkin's b-cell lymphoma

phase ii study of the efficacy and toxicity of rituximab, navelbine, ifosfamide, mitoxantrone, and prednisone in relapsed aggressive non hodgkin's b-cell lymphoma. the study intervention is an administration of 3 courses of the abovementioned drugs, witch doses are detailed below. remission is assessed and the investigator is free to proceed with any kind of consolidation , he decides best for the patient( high dose or standard chemotherapy). the addition of rituximab the the nimp protocol is warranted on the basis of previous publications wtich have shown a significant advantage in addition to chemotherapy in complete remission rate and in overall survival. navelbine has shown an interesting activity in lymphoma relapse. mitoxantrone has a good toxicity profile for patients who have prevously received anthracyclines, and there is not so much cross resistance between the two drugs. ifosfamide is commonly used in the treatment of relapsed and refractory lymphoma, because of its low hematologic toxicity profile and good antitumor activity.

Eligibility criteria:
inclusion criteria: * both genders, between 18 and 75 years old * cd 20+ large cell lymphoma * in first relapse * no previous autologous stem cell transplantation or relapsing more than 12 months after an autologous stem cell transplantation * ann arbor stage i, ii, iii ou iv * ecog 0,1 or 2 * signed informed consent exclusion criteria: * age: before 18 and more than 75 years old * other type of lymphoma * informed consent not signed

Keywords: relapsed aggressive b-cell lymphoma chemotherapy
stent versus balloon dilatation in patients with tracheal benign stenosis

Conditions: Tracheal Stenosis

Summary: this is a retrospective, observational cohort study carried out in two operative units of the university hospital of modena (italy): the diagnostic and interventional bronchoscopy unit (unit a) and the otolaryngology unit (unit b). the two units have different protocols routinely applied to treat tracheal benign stenosis. in unit a, endoscopic treatment is performed through mechanical dilatation via rigid bronchoscopy and further stent placing while in unit b the endoscopic treatment is performed through balloon dilatation via direct laryngoscopy. the primary purpose was to compare the efficacy of the two technique on tracheal stenosis treatment over time. patients were defined as "cured" if during the 2 years after 12 months since the last intervention they did not present any of the following: respiratory symptoms, need for a re-intervention or stenosis instability.


Eligibility criteria:
inclusion criteria: * age \>18 years, * exclusion from resection-anastomosis surgery after multidisciplinary evaluation, * cotton meyer \> grade ii, * follow-up of at least 3 years after endoscopic surgery, * no previous tracheal surgery. exclusion criteria: * age \> 80, * stent intolerance which requires removal in the first year after endoscopic treatment, * performance status \> 2, * end-stage chronic pulmonary disease, * life-threatening stenosis that needs urgent endoscopic treatments, * any neoplastic stenosis of the airways, * dynamic etiology of tracheal benign stenosis (excessive dynamic airway collapse, tracheobronchomalacia).
clinical study for patients with hypertension associated with dyslipidemia

Conditions: Hypertension; Dyslipidemia

Summary: the purpose of this study is to evaluate the efficacy and safety of dwj1276


Eligibility criteria:
inclusion criteria: * adult male and female in between ages of 20 and 80 at the time of screening * subject who can understand information provided and who can sign written consent voluntarily exclusion criteria: * patients with hypersensitivity to olmesartan and rosuvastatin * pregnant or lactating women and fertile women who is not using proper contraceptive method * patient with history of drug or alcohol abuse
a study of of glecaprevir/pibrentasvir in adults with chronic hepatitis c virus (hcv) genotype 5 or 6 infection

Conditions: Hepatitis C Virus (HCV)

Summary: a phase 3b, open-label, multicenter study to evaluate the efficacy and safety of glecaprevir/pibrentasvir for an 8- or 12-week treatment duration in participants with chronic hepatitis c virus (hcv) genotype (gt) 5 or 6 infection, with or without compensated cirrhosis respectively.


Eligibility criteria:
inclusion criteria: * screening laboratory result indicating hepatitis c virus (hcv) gt5 or 6 infection. * participant has a positive anti-hcv antibody (ab) and plasma hcv ribonucleic acid (rna) greater than or equal to 1000 iu/ml at screening visit. * participant must be hcv treatment-naïve (i.e., has never received a single dose of any approved or investigational anti-hcv medication) or treatment-experienced (i.e., has failed prior interferon \[ifn\] or pegylated interferon \[pegifn\] with or without ribavirin \[rbv\], or sofosbuvir \[sof\] plus rbv with or without pegifn therapy). prior hcv treatment with any other approved or investigational medications is not allowed. previous hcv treatment must have been completed greater than or equal to 2 months prior to screening. * participant must be documented as having no cirrhosis or compensated cirrhosis. exclusion criteria: * female participant who is pregnant, breastfeeding, or is considering becoming pregnant during the study or for approximately 30 days after the last dose of study drug. * recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator. * positive test result at screening for hepatitis b surface antigen (hbsag) or anti-human immunodeficiency virus antibody (hiv ab). * hcv genotype performed during screening indicating co-infection with more than one hcv genotype. * history of severe, life-threatening or other significant sensitivity to any excipients of the study drug.

Keywords: glecaprevir pibrentasvir compensated cirrhosis non-cirrhotic interferon (ifn) pegylated interferon (pegifn) ribavirin (rbv) sofosbuvir (sof) sustained virologic response 12 weeks post dosing (svr12) chronic genotype 5 or 6 infection
intraoperative assessment of surgical margins using confocal microscopy in comparison with reference extemporaneous examination

Conditions: Squamous Cell Carcinoma of Head and Neck; Basal Cell Carcinoma of Skin

Summary: study to evaluate the use of confocal microscopy for detecting resection margins in patients undergoing surgery for basal cell carcinoma of skin and squamous cell carcinoma of head and neck


Eligibility criteria:
inclusion criteria: * adult patient ≥18 years old * squamous cell or basal cell tumor (1 to 4 cm) of mucous or cutaneous origin. * patient whose surgical indication has been validated in a consultation meeting * patients with scheduled surgery * who\< or =2 * asa \< 3 * patient affiliated to the social security system * patient has understood, signed and dated the consent form. exclusion criteria: * history of irradiation in the surgical area * women who are pregnant or who are breast-feeding. * persons deprived of their liberty or under guardianship (including curators)

Keywords: margin surgical confocal microscopy conventional histopathology (h&e)
breastfeeding support and promotion program to improve the health of premature babies (pap-lm)

Conditions: Prematurity; Extreme; Prematurity

Summary: this study evaluates the effectiveness of a breastfeeding support and promotion program to increase exclusive breastfeeding rates in the preterm group. the intervention is performed by an advanced practice nurse and international board certified breastfeeding consultant (ibclc), with high expertise in breastfeeding problems. it is a combination of face-to-face, home care and telephone attention to improve the adherence to breastfeeding. the intervention lasts 6 months.

will be included moderately premature infants to the neonatal unit of the hospital clínic who achieve with the inclusion criteria of the study. the sample calculation includes 162 subjects to increase breastfeeding rates to 70% at discharge, 50% at 3 months and 40% at 6 months of the babies. mothers who wish to exclusively breastfeed up to 6 months and sign the informed consent, will be randomized into the experimental group or control group. the control group will receive usual care and the experimental group will receive 1 pre-discharge face-to-face session, 8 home care sessions up to 4 months and 3 telephone follow-up sessions up to 6 months of baby.

Eligibility criteria:
inclusion criteria: * moderate premature * late premature babies * admitted to the nicu of hospital clínic * single pregnancy * families residing in the barcelona metropolitan area (amb) * families with a good mental health * families with a desire for exclusive breastfeeding up to 6 months exclusion criteria: * maternal diseases that contraindicate breastfeeding * mothers with a history of breast surgery * mothers with a history of severe hypogalactia * premature babies with severe complications * premature babies diagnosed with severe cir

Keywords: ibclc advance practice nurse best practice breastfeeding rates breastfeeding outcomes interventions
image-derived prediction of response to chemo-radiation in glioblastoma

Conditions: Glioblastoma

Summary: this study seeks to investigate if advanced image-analysis of diagnostic scans, can be used to predict how aggressive brain tumors (glioblastoma) respond to standard chemo- and radiation treatment.

generally, response prediction models seeks to predict time to an event, e.g. time-to-progression and/or overall survival. the aim of this study is to explore the feasibility of establishing an individualized response model, that, based on several morphologic, physiologic and metabolic parameters extracted from computed tomography (ct), positron emission tomography (pet) and magnetic resonance imaging (mri), is able to predict the tumor response at the level of an imaging voxel, using machine learning techniques. imaging modalities include mri, pet/ct with 18f-fluroethyltyrosine (18f-fet), and pet/mri with 64cu-diacetyl-bis(n4-methylthiosemicarbazone) (64cu-atsm).

Eligibility criteria:
inclusion criteria: * histologically confirmed, primary supratentorial glioblastoma (who grade iv). exclusion criteria: * no informed consent can be obtained * inability to undergo mri examination, due to metal implants, pacemaker etc. * not eligible for stupp-regimen
serum sample collection to determine analytical performance characteristics of the advia centaur pappa and bhcg assays

Conditions: Trisomy 21 in Fetus; Trisomy 18 in Fetus; Trisomy 13 in Fetus

Summary: blood samples collected will be shipped to the sponsor's laboratory to establish analytical performance characteristics of the advia centaur® pregnancy associated plasma protein a (papp-a) and advia centaur® free beta human chorionic gonadotropin (free βhcg) assays.

blood samples are to be collected from pregnant women attending their scheduled 1st trimester scan; the samples are to be collected immediately after the subject's routine blood sample at the clinic visit. no extra venepuncture will be required. blood samples collected will be shipped to the sponsor's laboratory to establish analytical performance characteristics of the advia centaur® pregnancy associated plasma protein a (papp-a) and advia centaur® free beta human chorionic gonadotropin (free βhcg) assays.

Eligibility criteria:
inclusion criteria: * a subject is considered eligible for participation in the trial if all of the following inclusion criteria are satisfied prior to enrolment: 1. subject is ≥ 18 years of age 2. subject is informed and has been given ample time and opportunity to think about her participation and has given her written informed consent. 3. women with a structurally normal viable pregnancy with a fetal crown rump length of 45-84 mm exclusion criteria: * a subject is not eligible for participation in the trial if any of the following exclusion criteria are met prior to enrolment: 1. subject is unable to give consent 2. subject has already participated in the study
gastric per-oral endoscopic myotomy (g-poem) for the treatment of gastroparesis

Conditions: Gastroparesis

Summary: gastric per-oral endoscopic myotomy (g-poem) is a procedure for the treatment of gastroparesis.

gastroparesis is a disease of the stomach where there is significant delay in gastric emptying of contents to the intestines. this disease results in a multitude of symptoms including nausea, vomiting, weight loss, and malnutrition. current treatments for gastroparesis include dietary changes, oral medications (prokinetic agents to enhance gastric motility, acid reducers, anti-emetics to reduce nausea and vomiting), gastric stimulators and rarely surgery. g-poem (gastric per-oral endoscopic myotomy-creating a cut in the muscle that controls gastric emptying), an incision-less (no cutting of the surface of the body) endoscopic procedure, is increasingly being performed to assist in the management of certain groups of patients with gastroparesis. this data will be used for research purposes only to determine the clinical impact of endoscopic treatments on gastroparesis. the physicians will also be able to better understand the patient's condition and disease process that may lead to improved standard of care and improved patient management.

Eligibility criteria:
inclusion criteria: * 18 years of age * referral for endoscopic treatment of gastroparesis for symptom management exclusion criteria: * \< 18 years of age * absence of gastroparesis based on scintigraphy studies

Keywords: gpoem gastric per-oral endoscopic myotomy myotomy gastroparesis g-poem
gfr measurement with contrast-enhanced dynamic mri

Conditions: Transplantation, Kidney; Graft Occlusion, Vascular

Summary: the aim of the study is to optimize and validate this mr-based gfr measurement in patients with a renal transplant, compared with the reference method, the cr51- edta method: to select the most accurate combination of post-treatment of renal mr images and then evaluate its intra- and inter-rater reliability.

cr51- edta method is considered the reference method for measurement of glomerular filtration rate (gfr). however, this method requires several hours and several blood and urinary samplings. therefore, the ability to get access to this parameter with a simple, valid and reliable method would be a significant progress in clinical follow-up of patients with renal disease. contrast-enhanced dynamic mri is now able to give this access to functional parameters as gfr, rapidly and non invasively, becoming an alternative to cr51-edta method. if the acquisition method has been optimized, some problems remain unsolved: is the movement correction worthwhile for the accuracy of the measurement ? which model provides the most accurate results ? what is the best way to calculate the total gfr (addition of all the voxels or the product of a mean value by the cortical volume)? these questions can be answered only by a comparison with a reference method. the reference method will be performed after standard hydration, with intravenous injection of 100 µci of cr51- edta and urinary and blood samplings every 30 minutes during 3h. dynamic mri will be performed with fast 3d t1-weighted gradient-echo sequences during 5 minutes after injection of a third of a clinical dose of gadolinium. post-treatment of images will be done on an off-line program allowing movement correction, conversion of signal intensity into concentration and application of different models. 8 combinations of post-treatment will be tested and compared to the reference method.

Eligibility criteria:
inclusion criteria: * patient with a renal transplant presenting with a graft dysfunction or a suspicion of vascular complication (renal artery stenosis...) or of urinary complication (dilatation of excretory system, collection) justifying to perform a non urgent mr examination * calculated glomerular clearance (mdrd method) \> 20 ml/min * age ≥ 18 yo at the time of inclusion * negative pregnancy test * affiliation to the social security * written informed consent signed exclusion criteria: * contra-indication to mri: neurovascular clips, pacemaker, cochlear implant, orbital metallic object, claustrophobic patients... * contra-indication to gadolinium: previous hypersensitivity to gd-chelates * pregnancy or breastfeeding women * adult under legal supervision

Keywords: glomerular filtration rate measurement contrast-enhanced dynamic mr imaging renal transplant recipients
assessing short and long term compliance with caloric intake in hiv positive women taking complera

Conditions: HIV-1 Infection

Summary: the purpose of this research study is to evaluate how easy it is for female hiv- positive subjects taking complera to comply with the dietary requirement using a food diary in the short term (4 weeks) and long term (24 weeks and 48 weeks) and to determine association between calorie intake and virologic suppression. a secondary goal of the study is to evaluate subjects' attitudes towards contraception.


Eligibility criteria:
inclusion criteria: 1. hiv-1 infection documented by hiv serology or detectable viral load at any point prior to study entry or other documentation confirming hiv infection. if no documentation is available to confirm hiv infection, a rapid test may be performed to document hiv infection. 2. hiv+ female ≥18 years old and obtaining care at unc health care infectious diseases clinic, wake county human services clinic, or durham county early intervention clinic. patients receiving care at other clinics may be entered with approval of the study team. 3. hiv viral load (vl) \ than 6 months (but not \> 8 months) prior to the study entry visit are acceptable. a single "blip" of \> 50 and \< 200 copies/ml is permissible provided the most recent vl is \<50 copies/ml. 4. no documented resistance to ftc, tdf or rilpivirine. note: genotyping will not be performed on study. subjects with no historical genotype will be considered to have no documented resistance. 5. able and willing to provide informed consent. 6. in the opinion of the investigator, able to comply with study medication and procedures, including ability to complete food diary. 7. willing to receive monthly phone calls. 8. agreement between id clinic provider and study team that clinical monitoring and care of patient will reside with the id clinic provider. the study responsibility is limited to providing 48 weeks of complera. exclusion criteria: 1. any condition which, in the opinion of the investigator, would be likely to interfere with ability to take the study medications appropriately and comply with the study protocol. 2. current active illness requiring systemic treatment and/or hospitalization until the individual completes therapy or, in the opinion of the investigator, is clinically stable on therapy for at least 7 days prior to study entry. 3. acute viral hepatitis. 4. known allergy/hypersensitivity to components of the study drugs or their formulations. 5. current or expected use of medication on the prohibited medication list.

Keywords: complera short-term long-term compliance caloric intake hiv positive women
study of hr20013 for injection in patients with malignant solid tumors

Conditions: Prevention of Nausea and Vomiting Caused by Highly Emetogenic Chemotherapy

Summary: to evaluate the safety and pharmacokinetics of single-dose hr20013 for injection combined with dexamethasone in patients with malignant solid tumors receiving cisplatin-based chemotherapy.


Eligibility criteria:
inclusion criteria: 1. 18 years of age or older, of either gender 2. has a diagnosed malignant tumor 3. has never been treated with cisplatin and is to receive the first course of cisplatin-based chemotherapy (≥60 mg/m2) 4. predicted life expectancy of ≥ 3 months 5. has a performance status (ecog scale) of 0 to 1 6. adequate bone marrow, kidney, and liver function 7. women of childbearing potential must have negative pregnancy test (serum test) results within 72 hours prior to enrollment 8. able and willing to provide a written informed consent exclusion criteria: 1. scheduled to receive any radiation therapy to the abdomen or pelvis from day -7 through day 8 2. scheduled to receive any other chemotherapeutic agent with an high emetogenicity level from day 2 through day 8 3. has taken the following agents within the last 48 hours 5-ht3 antagonists, phenothiazines, benzamides, domperidone, cannabinoids, benzodiazepines 4. subjects receiving palonosetron hydrochloride within 14 days before enrollment 5. subjects who previously received nk-1 receptor antagonists within 14 days prior to enrollment 6. subjects with a history of myocardial infarction or unstable angina pectoris 7. subjects with atrioventricular block or cardiac insufficiency 8. subjects with poor blood pressure control after medication 9. subjects with symptomatic brain metastases or any symptoms suggestive of brain metastasis or intracranial hypertension 10. subjects who have experienced emetic events (vomiting or dry vomiting) or nausea within 24 hours prior to the start of cisplatin 11. participated in clinical trials of other drugs (received experimental drugs) 12. the investigators determined that other conditions were inappropriate for participation in this clinical trial