Kornimate/medical-research-clean huggingface dataset:
long-term use of takepron on the prevention of recurrence of gastric/duodenal ulcer in patients receiving non-steroidal anti-inflammatory drugs

Conditions: Gastric or Duodenal Ulcers

Summary: the purpose of this study is to investigate the safety and efficacy of long-term administration of lansoprazole (takepron) therapy for up to 12 months in the routine clinical setting in patients receiving oral non-steroidal anti-inflammatory drugs (nsaids)

this is a special survey on long-term use (for up to 12 months) of lansoprazole (takepron) to determine the incidence of adverse drug reactions in the routine clinical setting in patients receiving non-steroidal anti-inflammatory drugs (nsaids). the usual adult dosage is 15 mg of lansoprazole administered orally once daily.

Eligibility criteria:
inclusion criteria: * (1) patients with a history of gastric or duodenal ulcers (2) patients requiring long-term use of nsaids for reasons such as pain management for rheumatoid arthritis or osteoarthritis (3) patients taking oral nsaids at the start of administration of lansoprazole (including patients who start nsaids on the same day as the start of administration of lansoprazole) exclusion criteria: * (1) patients with gastric or duodenal ulcer (in the active \[a1, a2\] or healing \[h1, h2\] stage if assessed endoscopically) at the start of administration of lansoprazole (2) patients with active upper gastrointestinal hemorrhage at the start of administration of lansoprazole (3) patients with contraindications for lansoprazole

Keywords: pharmacological therapy
development of algorithms to predict hemodynamic instability

Conditions: Sudden Cardiac Death

Summary: hemodynamic monitoring in hospitalized patients is crucial since in clinical practice unexpected deterioration of cardiovascular function remains a serious problem and an important cause of death. novel perspectives in reflex testing of the autonomic nervous system might be useful to protect some patients from cardiovascular events by detecting cardiovascular deteriorations. in addition, standard pulse oximetry in low acuity settings is nowadays predominately used to monitor peripheral oxygen saturation. of note, there is evidence that additional analyses of pulse wave characteristics might be a valuable source of information to generate additional insights into the cardiorespiratory status of the patient. herein, we aim to develop novel algorithms in order to protect in-hospital patients from cardiovascular events in consequence of hemodynamic instability in the future.

70 datasets from hospitalized patients will be acquired in order to characterize the functional status of the autonomic nervous system as well as hemodynamics during baseline and during standard procedures including physical exercise testing and head-up tilt table testing. autonomic reflex testing: * heart rate characteristics * heart rate variability * heart rate turbulence * blood pressure variability * baroreflex sensitivity * hyperoxic chemoreflex sensitivity hemodynamic monitoring: * heart rate trends * blood pressure trends * pulse wave characteristics * cardiac output * peripheral vascular resistance * context information

Eligibility criteria:
inclusion criteria: * hospitalization * age \> 17 years exclusion criteria: * documented diseases of the central nervous system * impairment of mental health * age \> 85 years

Keywords: autonomic nervous system
motivation and adherence to psychotherapy assignments

Conditions: Behavioral Problems

Summary: the aims of this study are to experimentally investigate and compare whether motivation variables can predict adherence to a prescribed assignment in face-to-face and online interventions using a psychotherapy analogue model. a total of 100 participants are included in this study and randomized to either a face-to-face or online intervention. participants in both groups receive a psychoeducation session and are given an assignment for the subsequent week.

the aims of this study are to investigate (1) participants' different forms of motivations to complete a typical psychotherapy assignment, (2) participants' subsequent adherence to the prescribed assignment and the associations between motivations and adherence and (3) any differences regarding motivations, adherence and their associations between the face-to-face and online conditions. the hypotheses are that participants in the face-to-face condition will report higher motivation as well as higher adherence to the assignments compared to participants in the online condition, that adherence to the assignment will be positively associated with both autonomous motivation and externally regulated motivation and that adherence to the assignment will be more weakly associated with autonomous motivation in the face-to-face compared to the online condition. to investigate the association between motivation and adherence to assignments in face-to-face and online settings, this study have a longitudinal randomized design with two conditions. the two conditions are face-to-face psychoeducation with a therapist and online psychoeducation with therapist support. a psychotherapy analogue model with a one-session intervention for a non-clinical population is used. data is collected at baseline and at seven to nine days follow-up.

Eligibility criteria:
inclusion criteria: * having at least one problematic behavior one wished to understand or change exclusion criteria: * being below 18 years of age, having no access to a mobile phone and the internet, reporting elevated levels of depressive symptoms or currently attending psychotherapy.

Keywords: compliance
efficacy and safety of generic imatinib (carcemia®) compared to glivec® in real-life management of chronic phase of chronic myeloid leukemia

Conditions: Chronic Myeloid Leukemia

Summary: the purpose of this study is to evaluate efficacy and safety of generic imatinib (carcemia®) compared to glivec® in real-life management of chronic phase of chronic myeloid leukemia

this is an observational, prospective, cohort study design, where no visits or intervention(s) additional to the daily practice will be performed. in the study site, two cohorts will be identified among eligible patients, followed up, and assessed for a total of 12 months.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years 2. newly diagnosed patients with ph+ cml in cp, with or without the presence of other cytogenetic abnormalities at the time of diagnosis 3. treatment naïve patients with confirmed diagnosis within 3 months of study enrolment 4. levels of liver aminotransferases and serum bilirubin ≤ 2 times the upper limit of the normal range, and serum creatinine ≤1.5 times the upper limit of the normal range 5. written informed consent exclusion criteria: 1. cml in accelerated phase (ap) at enrolment except patients in ap with the presence of other cytogenetic abnormalities at the time of diagnosis 2. cml in bp at enrolment 3. patients who meet any of the contraindications to the administration of the study drug according to the approved summary of product characteristics. -

Keywords: imatinib carcemia leukemia cohort study effectiveness safety observational study cancer blood cancer health related qulaity of life glivec
investigation of administration of mct/ω-3 fatty acids is towards anti-inflammatory related fatty acid profile in preterm neonates.

Conditions: Premature Birth

Summary: intravenous administration of pure soybean oil emulsions high in linoleic acid may lead to inflammation and lipid peroxidation in preterm neonates. the aim of the present study was to investigate the effects of a medium-chain triglyceride (mct)/n-3 polyunsaturated fatty acid (pufa)-enriched intravenous fat emulsion (ivfe) on plasma fatty acid (fa) profile in preterm neonates. methods: in this double-blind randomized study, 92 preterm neonates (gestational age \<32 weeks, birth weight \<1500g) were assigned to receive either mct/n-3 pufa-enriched ivfe (intervention group) or soybean oil-based ivfe (control group). neonates' parents gave their informed written consent for inclusion in the study. levels of fas were measured at baseline (day 0) and day 15 of parenteral nutrition with gas-chromatography mass-spectrometry.


Eligibility criteria:
inclusion criteria: preterm neonates with gestational age \<32 weeks * birth weight \<1500 g * admitted to a tertiary neonatal intensive care unit within 12 hours after birth exclusion criteria: * anticipated needs for parenteral nutrition (pn) at ˃70% of total daily energy for \<10 days evidence of intrauterine infection, * perinatal asphyxia * major congenital anomalies * refusal of parental consent
a trial comparing efficacy, tolerability, and safety of gzr101 injection once daily (od) and gzr33-70 injection od

Conditions: Type 2 Diabetes

Summary: this trial is conducted in china. the aim of the trial is to compare the efficacy, tolerability, and safety of gzr101 injection and gzr33-70 injection in type 2 diabetes inadequately controlled on basal/ premixed insulin once daily at least with or without pre-dinner meal-time insulin.


Eligibility criteria:
inclusion criteria: * 1. signed the informed consent form (icf) before the trial, fully understanding the trial content, process and possible adverse reactions, and being able to comply with the contraindications and restrictions specified in this protocol. * 2.at the age of 18-75 (inclusive) at the time of informed consent, male or female. * 3.negative pregnancy test results for serum human chorionic gonadotropin (hcg) in women of childbearing potential at screening. * 4.diagnosed with type 2 diabetes mellitus above or equal to 6 months. exclusion criteria: * 1.presence or history of malignant neoplasm prior to screening. * 2.known or suspected hypersensitivity to investigational medical product(s) or related products. * 3.severe hypoglycemia (level 3 hypoglycemia) within 6 months prior to screening. * 4.history of acute heart failure within 6 months prior to screening or hospitalization for coronary heart disease, myocardial infarction, unstable angina, stroke within 6 months prior to screening. * 5. participated in another interventional clinical study within 4 weeks prior to randomization.
late-course accelerated hyperfractionated imrt for locoregionally advanced nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma

Summary: based on the radiobiological findings that accelerated tumor repopulation in nasopharyngeal carcinoma occurs in the late-course of radiation therapy, the investigators hypothesize that intensity-modulated radiation therapy(imrt) with concomitant boost schedule by increasing daily dose starting at the fifth week after initiation of imrt might improve tumor control and decrease treatment toxicities for locoregionally advanced nasopharyngeal carcinoma. the study is designed to test if late-course accelerated hyperfractionated imrt can improve the outcomes as compared with conventionally fractionated imrt in newly diagnosed patients with locoregionally advanced nasopharyngeal carcinoma.


Eligibility criteria:
inclusion criteria: * histologically proven non-keratinizing or undifferentiated type nasopharyngeal carcinoma for primary treatment with curative intent * according to ajcc 2002 staging system, clinical stage must be ⅱb-ⅳb * age between 18-70 * karnofsky performance status ≥70 * wbc ≥4,000/mm3, plt ≥ 100,000/mm3,serum creatinine ≤ 1.6 mg/dl * without radiotherapy or chemotherapy * signed study-specific consent form prior to study entry exclusion criteria: * patients with distant metastasis * pregnant or lactating women * the presence of uncontrolled life-threatening illness * patients who received radiotherapy or chemotherapy previously

Keywords: nasopharyngeal carcinoma locally advanced disease intensity-modulated radiation therapy accelerated hyperfractionation concomitant boost radiation therapy concurrent chemotherapy
relevance of t lymphocytes tumor infiltrates cd8 and foxp3 as immune prognostic biomarker in breast cancer treated by neo adjuvant chemotherapy

Conditions: Breast Cancer

Summary: neoadjuvant chemotherapy is standard therapy for the management of localised breast cancer, and makes it possible to evaluate tumour response. achieving pathological complete response (pcr) after chemotherapy is the most important prognostic factor for these patients. however, patients with pcr can suffer relapse. in parallel, long-term prognosis of patients who do not achieve pcr is poorly documented, and no specific prognostic factors have been clearly identified.preclinical and clinical studies argue for an immunogenic role of some chemotherapy regimens, such as anthracyclines, taxanes or trastuzumab. by facilitating recruitment of cd8 t-lymphocytes in the tumour bed, these agents could favourably influence antitumour immune response, partially contributing to efficacy. conversely, tumours can promote accumulation of regulatory t-lymphocytes expressing foxp3, thus evading anti-tumour immune response, and increased numbers of regulatory t-cells are associated with less favourable prognosis in breast cancer patients. we have previously shown that a high number of cd8 t-cells associated with low foxp3 infiltration, as quantified by immunohistochemistry on surgical specimens, is associated with better response and better survival in breast cancer patients, independently of whether pcr was achieved, the type of chemotherapy used, and the type of breast cancer. therefore, we propose to validate in a prospective study this immunological prognostic marker in a large cohort of patients treated with neoadjuvant chemotherapy.


Eligibility criteria:
inclusion criteria 1. signed informed consent 2. social security coverage 3. age between 18 and 80 years 4. histologically proven breast cancer, regardless of histological type or molecular subtype (triple negative, hormone-receptor positive, her2+++), including inflammatory forms 5. localised breast cancer with or without axillary or subclavicular lymph node involvement 6. absence of bone or visceral metastasis on further evaluation (bone scintigraphy, chest x-ray, abdominal echocardiography or ct scan of the thorax, abdomen and pelvic area) 7. treatment by neoadjuvant chemotherapy (treatment protocol at physician's discretion) 8. patient amenable to receiving adjuvant therapy (chemotherapy, radiotherapy, hormone therapy, targeted therapy) 9. breast surgery (breast-sparing or not) planned after neoadjuvant chemotherapy exclusion criteria 1. metastatic breast cancer 2. neoadjuvant radiotherapy 3. patient not amenable to surgery 4. ongoing therapy for any other type of cancer 5. legal incapacity (incarceration or persons under legal guardianship) 6. patient unable to sign the informed consent or unable to attend medical follow-up for geographical, social or mental reasons.

Keywords: breast cancer cd8+ foxp3 neoadjuvant chemotherapy
the value of full-targeted pathogen capture metagenomics next generation sequencing in etiological diagnosis of sepsis

Conditions: Sepsis, Severe

Summary: the etiological diagnosis of sepsis is the key to guide clinical treatment. metagenomic sequencing (mngs) is very suitable for the diagnosis of sepsis due to its rapid, accurate and not easy to be disturbed by the environment. however, the conventional pathogen mngs has potential risks such as low detection rate, loss of intracellular bacteria and fungi. at present, the latest fully targeted pathogen capture mngs technology makes up for the shortcomings of conventional methods by bidirectional enrichment of pathogen nucleic acids. the aim of this study was to explore the value of fully targeted pathogen capture mngs in improving etiological diagnosis in patients with sepsis compared with conventional methods.

this study planned to continuously collect samples from patients with sepsis who were admitted to the intensive care unit of our hospital from 2022.08 to 2024.07, and conduct whole-target pathogen capture mngs detection and follow-up etiological diagnosis based on blind method. the clinical diagnosis with clear etiology was taken as the gold standard.

Eligibility criteria:
inclusion criteria: * critical care patients aged ≥ 18 years old * patients with sepsis exclusion criteria: * lack of traditional pathogen detection results * discharge diagnosis without clear etiology
effect of spinal manipulation on experimental pain in asymptomatic subjects.

Conditions: Spinal Manipulation

Summary: spinal manipulation is often used for its effect on pain, but more information is needed concerning its mechanisms of action.

the effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects should be challenged by a validated sham procedure, regionally and remotely over time. further information is needed concerning its duration and its size. research questions: 1. what is the regional effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects, when compared to a valid sham procedure? 2. what is the remote effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects, when compared to a valid sham procedure? 3. what is the duration of the effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects? 4. what is the size of the effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects over time?

Eligibility criteria:
inclusion criteria: * the subjects must be young (18-30 years old) * asymptomatic (no pain in the tested area, but the study accepts pain elsewhere, as long as it is less than 1/10 on the box-scale). * chiropractic students. exclusion criteria: * the subjects must not be reporting any spinal pain lasting more than a month * and/or having taken painkillers 24h prior to the study. * contra-indications to the spinal manipulation (instability, fracture, malformation, bone or ligament fragility, and inflammations).

Keywords: pressure pain threshold asymptomatic subjects duration
study of circulating tumoral dna in ovarian cancer

Conditions: Ovarian Cancer

Summary: circulating tumor dna detection and quantification in patients with ovarian cancer.

technique development: in a first step, the different available techniques will be evaluated for specificity and sensibility using serial dilutions of cell lines with or without tp53 mutation. validation: the tumor dna detection rate will be estimated from patient's blood with ovarian cancer. the investigators will study 25 patients to obtain at least 15 patients bearing a tp53 mutation that could be characterized in the primitive tumor or metastasis. with those 15 patients, the investigators will determine the most sensitive technique and the best cost/efficiency ratio.

Eligibility criteria:
inclusion criteria: * age \> or = 18 years. * patient with invasive ovarian cancer stage ii to iv from figo classification. * patient treated by surgery. * patient with tumor or metastasis available for tp53 status characterization * patient able to stand a blood collection. * signed written informed consent approved by afssaps and cpp. exclusion criteria: * patient without social protection / insurance. * borderline ovarian tumor. * non carcinoma ovarian tumor * patient with invasive ovarian cancer 5 years before diagnosis * current pregnancy and lactation. * all social, medical, psychological, situations making the study impossible. * person deprived of liberty.
nicotine patch - bioequivalence study

Conditions: Healthy Smokers

Summary: the purpose of this study is to evaluate the bioequivalence of a new transdermal nicotine patch to that of a reference formulation following repeated applications


Eligibility criteria:
inclusion criteria: * healthy male subject aged 18 to 45 years (inclusive) * current smoker of \>or = 5 and \< or = to 15 cigarettes/day * fagerström score \< or =5 at selection * absence of any clinically significant abnormal findings at physical examination, vital sign, electrocardiogram ecg, biological examinations in the investigator's opinion. exclusion criteria: * presence of any significant medical findings or significant history (in particular any cardio-vascular disease, severe renal or hepatic insufficiency, current gastric or duodenal ulcer) that may impact the safety, the interpretation of the results and/or the participation of the subject in the study according to the opinion of the investigator * any visible skin disorder, abnormal skin pigmentation or dermatologic disease liable to interfere with use or safety assessment of a transdermal patch

Keywords: smoking cessation nicotine tobacco use disorder central nervous system agents
second-line intravenous treatment for recurrent platinum-sensitive ovarian, fallopian, or peritoneal cancer

Conditions: Peritoneal Cancer; Ovarian Cancer; Neoplasms, Ovarian; Fallopian Tube Cancer

Summary: this research study was designed to determine the effectiveness of the drug, topotecan, given intravenously (into a vein) together with the drug gemcitabine in patients with recurrent platinum-sensitive ovarian, fallopian or primary peritoneal cancer, as well as tumors of mixed mullerian origin. additional purposes are to determine the long term outcome and side effects of this combination treatment. since topotecan and gemcitabine have different mechanisms of action, the combination of these 2 drugs may provide better results than either drug alone. prior studies suggest that the combination of topotecan and gemcitabine improves the effects on the tumor and also appeared to be well tolerated.


Eligibility criteria:
inclusion criteria: * have had one prior platinum-based chemotherapy regimen for the treatment of primary disease. * at least 4 weeks since last surgery or radiation therapy. * must have had a treatment-free interval of greater than 6 months following response to platinum. * ecog performance status of 0,1, or 2. exclusion criteria: * women of child-bearing potential that do not practice adequate contraception. * pregnant or lactating. * received more than one primary chemotherapy regimen. * concomitant or previous malignancies with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, incidental carcinoid, or other cancer from which the patient has been disease free for 5 years. * active uncontrolled infection requiring antibiotics. * concurrent severe medical problems unrelated to the malignancy which would limit full compliance with the study. * received radiation to more than 10% of bone. * prior treatment with topotecan or gemcitabine. * hypersensitivity to camptothecin or nucleoside analogues. * use of an investigational agent within 30 days.

Keywords: ovarian cancer peritoneal cancer cancer fallopian cancer