Kornimate/medical-research-clean huggingface dataset:
an observational study of follitropin alpha biosimilar: the real-world data

Conditions: Reproductive Issues; Reproductive Disorder; Fertility Disorders; Fertility Issues; Gynecologic Disease; IVF

Summary: aim to investigate the efficacy of follitropin alpha biosimilar therapy (primapur®) in nonselected real-world population.

a retrospective observational anonymized cohort study of follitropin alpha biosimilar (primapur®) as a pre-filled pen injector with a dose adjustment of 5 iu, aimed to investigate its efficacy and safety in a nonselected population with indications to assisted reproductive technologies (art) was carried out. the ovarian stimulation (os) protocols included: monotherapy protocols with using only primapur®; mixed protocols (recombinant and urinary-derived gonadotropins); short protocols with using antagonists of gonadotropin-releasing hormone (gnrh) and long protocols with gnrh agonists. the stimulation protocols were analyzed with primapur® application for at least 5 days.

Eligibility criteria:
inclusion criteria: * women with established causes of infertility and indications for the use of art methods, according to the order of the ministry of health of the russian federation "on the use of assisted reproductive technologies, contraindications and limitations to their use" no. 107 n dated august 30, 2012. * infertility due to female and/or male factor. * presence of ovaries accessible for aspiration of follicles. * anatomical and functional capability of uterus to bear pregnancy. exclusion criteria: * women with established contraindications to the use of art methods, according to the order of the ministry of health of the russian federation "on the use of assisted reproductive technologies, contraindications and limitations to their use" no. 107 n dated august 30, 2012. * presence of pregnancy * hypersensitivity to follitropin alfa or excipients. * ovarian cysts (not associated with polycystic ovarian syndrome), uterine hemorrhage of unclear etiology * premature ovarian failure * presence of clinically significant systemic disease * presence of chronic cardiovascular, hepatic, renal or pulmonary disease * neoplasia * narcomania, alcoholism

Keywords: follitropin alpha follicle-stimulating hormone in vitro fertilization assisted reproductive technologies biosimilar follitropin alfa real-world data
reliability of different fot devices to measure the human respiratory impedance

Conditions: Pulmonary Disease; Healthy

Summary: the objective of the study is to evaluate the reliability of the impedance data in adult subjects measured with five different fot devices.

the purpose of the study is to evaluate the reliability of the respiratory impedance measured with different fot (=forced oscillation technique) devices. to this end, the respiratory impedance of fifty adult subjects will be measured in random order with five different forced oscillation devices. as there is no "gold standard" fot-device, each setup will be compared to all other setups. secondary study questions are: 1) is there a specific comfort (or discomfort) associated with the different measuring devices 2) guidelines state that full chin and cheek support should be applied when measuring the human respiratory impedance. what is the influence of a partial cheek support?

Eligibility criteria:
inclusion criteria: * healthy adult subjects * adult patients with obstructive lung disease exclusion criteria: * inability to perform lung function tests * patients with respiratory failure * patients on bipap-therapy * patients on supplemental oxygen.

Keywords: respiratory resistance respiratory reactance adult lung function forced oscillation technique subjects
phase 2 study - erdosteine in patients with cb/copd

Conditions: Chronic Bronchitis; Chronic Obstructive Pulmonary Disease

Summary: this clinical study is designed to explore dose ranging and identify methods to demonstrate the efficacy of erdosteine in patients with stable chronic bronchitis associated with chronic obstructive pulmonary disease.


Eligibility criteria:
inclusion criteria: * adult patients with a clinical diagnosis of stable cb associated with copd will be entered into this study. cb is diagnosed clinically in patients who have a documented smoking history and who have a daily productive cough for at least 3 months per year over at least 2 consecutive years in the absence of other causes of chronic cough. copd is defined by the presence of airflow obstruction from spirometry exclusion criteria: asthma, bronchiectasis, or cystic fibrosis; active history of lung cancer, respiratory failure, or a need for long-term oxygen therapy;

Keywords: chronic bronchitis chronic obstructive pulmonary disease
physical therapy using virtual reality/augmented reality

Conditions: Mobility Limitation; Spinal Fusion; Acute Pain

Summary: the purpose of this study is to determine if non-invasive distracting devices (virtual reality (vr) headset, augmented reality (ar) headset) are more effective than the standard of care (i.e., no technology-based distraction) for improving clinical outcomes in patients requiring acute rehabilitation due to deconditioning and surgery. measures will include include range of motion, gait progression, strength progression, time to first out of bed, time to first step.


Eligibility criteria:
inclusion criteria: * age 6-99 * diagnosis need for physical rehabilitation exclusion criteria: * significant cognitive impairment * history of severe motion sickness * current nausea * seizures * visual problems * patients whose children are clinically unstable or require urgent/emergent intervention * patients who clinically unstable or requires urgent/emergent intervention

Keywords: virtual reality augmented reality physical therapy deconditioning
study to investigate the safety and efficacy of k-321 in patients with fuchs endothelial corneal dystrophy (fecd) following descemetorhexis

Conditions: Fuchs' Endothelial Corneal Dystrophy

Summary: the objective of this study is to investigate the effect of k-321 in patients with fuchs endothelial corneal dystrophy (fecd) after descemetorhexis.


Eligibility criteria:
inclusion criteria: * is at least 18 years old at the screening visit (visit 1). * has a diagnosis of fecd at visit 1. * meet all other inclusion criteria outlined in clinical study protocol. exclusion criteria: * has a study eye with a history of cataract surgery within 90 days of visit 1. * has a study eye with a history of any previous ocular surgery other than for cataract. * meet any other exclusion criteria outlined in clinical study protocol.
study of immune response and liver damage induced by chemotherapy for liver metastases of colorectal cancer

Conditions: Resectable Hepatic Metastases of Colorectal Cancer

Summary: the immune response at primary tumor has a major role in the prognosis of colorectal cancer (crc). some studies suggest a prognosis value of cytotoxic t cell and memory t cells at primary tumor greater than tumoral stage. there is no work in the literature that has examined the prognosis value of the immune response in liver metastases. to study immune cells (histology) and inflammatory response (cytokines) in liver metastases is a challenge to understand the effectiveness of chemotherapy used in this situation. the chemotherapy used in liver metastases of colorectal cancer also have effects on non-tumoral liver tumor and therefore can interfere with postoperative complications of hepatic resection. sinusoidal dilatation is present in 20% to 80% of patients who received oxaliplatin before hepatectomy. steatosis is frequently observed after administration of 5-fu alone or in combination with irinotecan. this steatosis may also be accompanied by inflammatory lesions (steatohepatitis), especially after administration of oxaliplatin or irinotecan and is associated with increased postoperative mortality. the hepatic toxicity of new biological agents is not well known (cetuximab and bevacizumab). the mechanisms of chemotherapy-induced toxicities are currently unknown. the main objective is to analyze the profile of the immune response in liver metastases of crc and find the link with the radiological response. measurements will be made by quantitative rt-pcr on frozen liver biopsies. secondary objective is to seek a correlation between the histological lesions induced by chemotherapy and non-invasive tests for liver fibrosis. the secondary endpoints are rate of immune cells, histologic response (percentage of tumor necrosis), disease-free survival, the non-invasive test of fibrosis, the chemotherapy-induced liver injury, cytokines and circulating angiogenic factors.


Eligibility criteria:
inclusion criteria: patient older than 18 years. * patients with histologically proven colorectal cancer with resectable or potentially resectable liver metastases. * first line chemotherapy alone or combination with intravenous 5fu, oral 5fu (capecitabine), oxaliplatin, irinotecan, cetuximab, panitumumab or bevacizumab (lv5fu2, xeloda, folfiri, folfox, xelox, xeliri alone or in combination with either cetuximab or panitumumab or bevacizumab). * signature of informed consent. * patient affiliated to french social security. exclusion criteria: patients taking immunosuppressive therapy. * lack of measurable tumoral target. * patients with a contre-indication of all chemotherapy used: oxaliplatin, irinotecan, fluorouracil, capecitabine, cetuximab, panitumumab, bevacizumab. * patients hospitalized without consent. * patients in emergency situations. * patients under guardianship. * patients deprived of their liberty by judicial or administrative procedure. * pregnant or nursing women, women without effective contraception.
is phonophoresis treatment effective?

Conditions: Osteoarthritis, Knee

Summary: the specimens from patients as knee osteoarthritis diagnosed who was applied ibuprofen phonophoresis will be analyzed.


Eligibility criteria:
inclusion criteria: * having diagnosed as osteoarthritis exclusion criteria: * surgery at knee * trauma at knee

Keywords: ibuprofen phonophoresis high performance liquid chromatography
comparative study of antibacterial effect on silver dressing of negative pressure wound

Conditions: Diabetes Mellitus

Summary: the purpose of this study is to test therapeutic benefits of silver dressing compared with non-silver dressing in npwt(negative pressure wound therapy). silver dressing may antibacterial effect on infected diabetes mellitus foot.

investigator will recruit sixty patients. participant will be randomly assigned to one of two groups. one is using silver dressing group in npwt, another is using non-silver dressing group in npwt. participant will visit in screening day, npwt apply day and f/u day for 4 months. investigators will conduct to check the wound base, lab, wound culture.

Eligibility criteria:
inclusion criteria: * the patient above 20 years and has type i, ii of diabetes mellitus foot ulcer * infected ulcer has one of below. 1. clinically infection symptom in ulcer area : warmth, erythema, tenderness/swelling * induration, purulent discharge etc. 2. confirmed case of bacteria in wound culture. 3. conformed case of abnormal range of erythrocyte sedimentation rate (esr)/c-reactive protein(crp) level in lab. * has to be applied npwt because suture is impossible in ulcer area. * the patient voluntary agreed to this protocol. * in the opinion of investigator, it is suitable to participate in this study. exclusion criteria: * infection in bone so patient need amputation * female with childbearing, lactating or not agree to prevent pregnancy. * has sepsis, osteomyelitis * has connective tissue disease of disturbance of healing of wound ex) rheumarthritis,systemic lupus erythematosus(sel), myalgia. * the patient to diagnosis of sickle sell disease or charcot's joint. * the patient stability treated chronic wasting disease. * malignant tumor or history of malignant disease. (not diagnosis of complete recovery.) * the patient treated chemotherapy, radiation therapy, immune-suppressants therapy,adrenocortical hormones therapy. * although necrosis tissue is removed, the target ulcer did not heal because of gangrenous, necrosis tissue or purulent pyorrhea. * has ulcer with cardiac arrhythmia thrombus, venous insufficiency, diabetic necrobiosis lipoidic. * in case of using prohibited concomitant medications during study. a. oral system steroid b. immune-suppressive drug c. unfractionated heparin infusion d. improper drugs in the opinion of investigator. * hypersensitivity with applicators. (npwt, silver) * the patient participated in other clinical trials within 30 days * in the opinion of investigator, the patient is not suitable to participate in this study.

Keywords: silver dressing npwt dmf foot
antibodies response to mrna vaccine against covid-19

Conditions: Covid-19

Summary: vaccine rollout has started in many countries. in italy, the covid-19 vaccine used at the moment is the mrna-based bnt162b2 and is given to hospital employers. the investigators undertake this study to monitor igg evolution after vaccination in the participant hospital settings, which includes 500 subjects.

vaccine rollout has started in many countries. in italy, the covid-19 vaccine used at the moment is the mrna-based bnt162b2 and is given to hospital employers. the investigators undertake this observational study to monitor antibody evolution after vaccination in a hospital setting. the primary endpoint is serum igg at the first month of 2nd jab, and at 3, 6, and 12 months afterward. as secondary measures, nasopharyngeal swabs are included, at fortnight intervals to detects the spike protein antigen, in the event that putative vaccine inefficacy would expose the health personnel to covid-19 disease with potential spreading to inpatients. further, clinical signs and symptoms are monitored at the weekly interval in the context of adverse reactions/events.

Eligibility criteria:
inclusion criteria: * hospital employers vaccinated against sars-cov2 exclusion criteria: * none

Keywords: vaccine covid-19 safety sars-cov2
bicentric clinical investigation to assess safety and performance of luxboost iol

Conditions: Aphakia

Summary: the study purpose is to demonstrate safety and performance of bilateral implantation of luxboost intraocular lenses compared with the luxgood monofocal lens.

the study purpose is to demonstrate safety and performance after bilateral implantation of luxboost intraocular lenses. the device under investigation is a hydrophobic acrylic monofocal intraocular lens (iol) manufactured by the sponsor of this study.

Eligibility criteria:
inclusion criteria: * subject aged 50 or over on the day of inclusion, presenting a * bilateral cataract for which posterior chamber iol implantation * has been planned. * fit within the available iol diopter range. * have had no previous refractive surgery. * regular corneal astigmatism \< 1 dioptre by an automatic * keratometer (regularity measured by topographer). * availability, willingness, and sufficient cognitive awareness to * comply with examination procedures. * ability to attend all study follow-ups. * signed informed consent. exclusion criteria: * ocular surface disease potentially affecting study results * subjects suffering from diagnosed degenerative visual disorders * pre-existing ocular pathology * acute or chronic disease or illness that would increase risk or confound study results * axial lengths and keratometry such as the iol spherical power is * not in the range of 14 to 28 d * instability of keratometry or biometry measurements * amblyopia * history of ocular trauma or any prior ocular surgery including refractive procedures * capsular or zonular abnormalities that may affect postoperative centration or tilt of the lens

Keywords: enhanced monofocal iol
a study of tcd601 in the induction of tolerance in de novo liver transplantation

Conditions: Liver Transplantation

Summary: the purpose of this study is to evaluate if treatment with a siplizumab-based regimen can induce allogeneic tolerance in liver transplant recipients.


Eligibility criteria:
inclusion criteria: * able to understand the study requirements and provide written informed consent before and study assessment is performed * adult subjects aged 18-70 receiving an abo compatible deceased donor liver transplant * male study subjects willing to maintain barrier contraception (condom) and agree not to father a child until 12 weeks after the last dose of mmf exclusion criteria: * pregnant or nursing (lactating) women * subjects with a history of tb or latent tb infection * subjects with a history of cancer
tap block with magnesium sulfate added to local anesthetic in abdominal hysterectomy

Conditions: Postoperative Pain

Summary: major abdominal surgeries are associated with severe abdominal pain, which can affect respiratory and cardiac functions, if insufficiently managed. this increases the incidence of post-operative morbidity. the objective of this study was to detect the efficacy and safety of magnesium sulphate as an adjuvant to the analgesia offered by local anesthetic in ultrasound guided tap block in patients undergoing total abdominal hysterectomy.


Eligibility criteria:
inclusion criteria: * weight: 50- 85 kg. * asa score: i-iii * scheduled for total abdominal hysterectomy exclusion criteria: * history of relevant drug allergy. * coagulation disorders. * opioid dependence. * sepsis. * psychiatric illnesses that would interfere with perception and assessment of pain.

Keywords: magnesium sulfate postoperative pain tap block total abdominal hysterectomy
alvopem® (pemetrexed) safety assessment

Conditions: Non Small Cell Lung Cancer; Malignant Pleural Mesothelioma

Summary: the present study was a phase iv, post-marketing, observational study for safety evaluation of alvopem® use in iranian patients with non-small cell lung cancer and malignant pleural mesothelioma. no control groups were included in the study design. the primary objective of this study was safety assessment, including the incidence of adverse events (aes).

the present study was a phase iv, post-marketing, observational study for safety evaluation of alvopem® use in iranian patients with non-small cell lung cancer and malignant pleural mesothelioma. data was gathered in one booklet, which had 6 different periods. the patients' information assessed after each injection, every 3 weeks. these booklets were completed by designated physicians. the primary objective of this study was safety assessment, including the incidence and intensity of aes and serious adverse events (saes). this study was single arm and the sample size of this study was 199 patients.

Eligibility criteria:
inclusion criteria: patients diagnosed with non-small cell lung cancer and malignant pleural mesothelioma under chemotherapy regimens with alvopem® were enrolled in the study. exclusion criteria: there were no exclusion criteria for this study.

Keywords: nsclc; observational study; pemetrexed; pms; safety
the effects of nutritional intervention in participants with eating disorders.

Conditions: Eating Disorders; Binge-Eating Disorder; Binge Eating Disorder Associated With Obesity; Eating Behavior; Eating Disorder

Summary: the goal of this clinical trial is to evaluate the effects of nutritional intervention in eating disorders. participants underwent an intervention without a control group over 8 weeks. this study aims to provide the maximization of nutritional rehabilitation and support changes in the construction of food autonomy, through a food and nutritional intervention.

analyze the impact of nutritional intervention on changes in dietary habits, episodes of binge eating, body image dissatisfaction, quality of life and anthropometric data (weight, bmi and waist circumference) of participants with bed. this quantitative, prospective, longitudinal and experimental study recruited 82 participants diagnosed with obesity and bed. the intervention was divided into 8 individual weekly meetings, guided by mindful eating session, nutritional educational dynamics, cooking workshop, food sensory analysis and applications of questionnaires (body image scale - bsq; binge eating scale - bes; quality of life scale - whoqol bref). the meetings occurred from october to november 2023.

Eligibility criteria:
inclusion criteria: * individuals diagnosed with bed who are available to participate exclusion criteria: * individuals without a diagnosis of bed who are available to participate; who cannot attend meetings; with clinical changes; who have difficulty answering the questionnaires

Keywords: eating disorders binge eating disorder eating behavior eating disorder
assessment of the psychological impact of the covid19 (sars-cov-2) pandemic on patients with chronic inflammatory rheumatism

Conditions: Rheumatism

Summary: patients with chronic inflammatory rheumatism (ric) or autoimmune diseases, rheumatoid arthritis and spondyloarthritis, are regularly monitored in consultation as part of a "treat to target" strategy with rapid adaptation of treatments to the activity of their disease. according to french recommendations. they are treated with immunosuppressive drugs: disease-modifying treatments with very often methotrexate, associated with biotherapies or targeted therapies (jak inhibitors) they can also be treated transiently or over the long term with corticosteroids. these treatments expose them to greater infectious risks, especially with regard to covid19. the objective is on the one hand to assess the impact of the covid 19 pandemic on general state of health of these patients and the evolution of their disease and on the other hand to prioritize the optimal care of these patients by including in the context of maintaining the pandemic reduction rules, modern telemedicine technologies.


Eligibility criteria:
inclusion criteria: all patients with chronic inflammatory rheumatism followed in the rheumatology department of the chu de limoges. exclusion criteria: patients who object to the use of their data.