Kornimate/medical-research-clean huggingface dataset:
homologus prp in the infiltrative treatment of knee osteoarthritis in young athletic patients

Conditions: Knee Osteoarthritis

Summary: the study consists of 3 phases (enrollment, infiltrative procedure, and controls): * identification by specialized orthopedic medical staff belonging to the sc orthopedic and trauma clinic ii of the rizzoli orthopedic institute of subjects who meet the study inclusion criteria. signing of informed consent form and completion of evaluation questionnaires. * infiltrative procedure * patients will be clinically evaluated before the infiltration procedure and at 1, 3, 6, and 12 months after treatment by trained medical personnel (outcome assessors). questionnaires will be administered for clinical evaluations before treatment and at these clinical checkups during follow-up. any adverse events to treatment will also be assessed during follow-up visits. the duration and extent of joint swelling and pain following infiltration will be reported, and any drug therapies taken by the patient will be recorded.


Eligibility criteria:
inclusion criteria: * patients, both sexes, with symptomatic knee osteoarthritis with: * age: 18-40 years; * unilateral involvement; * signs and symptoms of knee osteoarthritis; * radiographic or mri signs of degenerative pathology of knee cartilage (kellgren-lawrence grade 1-3); * ability and consent of patients to actively participate in clinical follow-up; * signature of informed consent; * pain ≥ 4 on vas s exclusion criteria: * patients unable to express consent; * patients undergoing intra-articular infiltration of other substance in the previous 6 months; * patients undergoing knee surgery in the previous 12 months; * patients with malignant neoplasms; * patients with rheumatic diseases; * patients with uncontrolled metabolic diseases; * patients with hematological diseases (coagulopathies); * patients abusing alcoholic beverages, drugs or medications; * knee trauma treated in the previous 6 months. * other conditions that may interfere with the evaluation of oa treatment.
a study on efficacy and safety of menopur® multidose in korean female patients with infertility

Conditions: Infertility

Summary: the purpose of this study is to investigate the ongoing pregnancy rates at 10-11 weeks after embryo transfer in patients treated with menopur® multidose


Eligibility criteria:
inclusion criteria: * decision made to prescribe menopur® multidose according to summary of product characteristics * the study cycle will be either * 1st controlled ovarian stimulation cycle ever, or * 2nd controlled ovarian stimulation cycle ever, or * 1st or 2nd controlled ovarian stimulation cycle after having achieved ongoing pregnancy in a previous controlled ovarian stimulation cycle (note: the subject cannot be included if she has had made more than one failed cycle before the cycle resulting in ongoing pregnancy) exclusion criteria: * known ovarian disease (e.g. ovarian cysts, polycystic ovarian disease etc.) * diagnosed as "poor responder", defined as either * \>20 days of gonadotrophin stimulation in a previous controlled ovarian stimulation cycle, or * any previous cancellation of a controlled ovarian stimulation cycle due to limited follicular response, or * development of less than 4 follicles ≥15 mm in a previous controlled ovarian stimulation cycle * ovarian hyperstimulation syndrome (ohss)
angiography versus (vs) ivus optimisation

Conditions: Myocardial Infarction

Summary: the purpose of the study id to demonstrate an advantage for intra-vascular ultrasound (ivus) optimized drug-eluting stent (des) implantation compared to angiography in complex lesions


Eligibility criteria:
inclusion criteria: * a complex lesion is regarded as a lesion where the operator would expect a lower immediate and long term success rate compared to non-complex lesions (according to the results of randomized controlled trials and from large registries). the operator must consider the implantation of a drug-eluting stent, feasible and appropriate for this particular complex lesion exclusion criteria: * contra-indication to dual anti-platelet therapy. * ejection fraction \<30%. * renal failure (creatinine \>2 mg/dl). * significant co-morbidity precluding clinical follow-up. * acute myocardial infarction in the 48 hours prior to the procedure. * in-stent restenosis * prior brachytherapy * thrombocytopenia \<100,000 * unprotected left main stem stenosis * venous or arterial grafts * recipient of heart transplant * a positive pregnancy test in women with child bearing potential * acute infections * major surgery planned which will lead to discontinuation of antiplatelet therapy * patients with prior bms or des implanted in the target vessel less than one year prior to the enrollment, including one year from any intercurrent restenotic or thrombotic event * age under 18 years old. * there is no maximum number of lesions which can be treated

Keywords: patients with at least one complex lesion suitable for implantation of a drug-eluting stent
incorporating flow limitation into the diagnosis and quantification of sleep disordered breathing

Conditions: Sleep-Disordered Breathing

Summary: the diagnosis and treatment of sleep disordered breathing have come to the forefront of clinical medicine following recognition of the high prevalence and associated morbidity of sleep apnea. the effects on quality of life as well as societal costs have been well documented. the nyu sleep research laboratory has spent the last several years working on the problem of improving the diagnosis of mild sleep disordered breathing which manifests as the upper airway resistance syndrome. our approach has been to develop a non-invasive technique to detect increased upper airway resistance directly from analysis of the airflow signal. a characteristic intermittent change of the inspiratory flow contour, which is indicative of the occurrence of flow limitation, correlates well with increased airway resistance. currently all respiratory events are identified manually and totaled. this is time consuming and subject to variability. the objective of the present project is to improve upon the manual approach by implementing an artificially intelligent system for the identification and quantification of sleep disordered breathing based solely on non-invasive cardiopulmonary signals collected during a routine sleep study. the utility of other reported indices of sleep disordered breathing obtained during a sleep study will be evaluated. successful development of an automated system that can identify and classify upper airway resistance events will simplify, standardize and improve the diagnosis of sleep disordered breathing, and greatly facilitate research and clinical work in this area. using a physiological based determination of disease should allow better assessment of treatment responses in mild disease.


Eligibility criteria:
inclusion criteria: * patients with sleep disordered breathing
med-el remote care multi-center feasibility study

Conditions: Hearing Loss, Sensorineural; Cochlear Implant; Cochlear Implant Recipients; Hearing Disorders; Cochlear Implants

Summary: med-el remote care is a way for med-el cochlear implant users to check their hearing and cochlear implant device from any location, without the need for a scheduled, in-person appointment with their audiologist. this study will assess the effectiveness, efficiencies, and useability of med-el remote care.

this prospective multicenter study will include med-el cochlear implant users from the us and canada. this study will assess the effectiveness, efficiencies, and useability of med-el remote care.

Eligibility criteria:
inclusion criteria: * implanted with at least one med-el cochlear implant * ≥ 2 weeks since activation of the cochlear implant * availability of existing aided pediatric/az bio (quiet and/or noise) and cnc word scores, or the ability to complete these at baseline * utilizing a compatible audio processor in the sonnet or rondo product lines * ability to complete app-based hearing assessments * commitment to comply with all study procedures for the duration of the study * access to the internet via a smartphone that meets the following requirements: * android or ios operating systems * a smartphone supporting bluetooth® 4.2 or higher * a minimum of 200 mb free storage space exclusion criteria: * inability or unwillingness to perform the requirements of the clinical investigation * unrealistic expectations regarding the possible benefits, risks, and limitations of remote cochlear implant care * inability of the subject or caregiver to demonstrate basic skills for operating a smartphone, computer, or app-based tasks after training by the investigator

Keywords: cochlear implants telehealth remote care
evaluation of the incidence of ntrk gene fusion in adult brain tumours

Conditions: Glioma

Summary: this is a retrospective, mono centric, exploratory study to assess the incidence of a genomic alteration: ntrk gene fusion, in adult gliomas and brain metastases.

retrospective mono centric study of medical data (clinical, histological, molecular and imaging) from medical records and analysis of available excisional tissue samples.

Eligibility criteria:
inclusion criteria: * adult male or female subject; * glioma or brain metastasis operated on in our institution, histologically confirmed (who classification 2016); * subject with a frozen tumour sample \< 5 years old; * subject for whom all clinico-radiological data are available; * subject affiliated to a health insurance scheme; * subject who has been informed of the research and who has not indicated his opposition to the use of his medical data and who has signed a consent for the use of his tumour sample. exclusion criteria: * patient under legal protection, guardianship or deprived of liberty by judicial or administrative decision * biological samples not available and/or in insufficient quantity for analysis
influence mechanism of tumor microenvironment changes on neoadjuvant therapy for esophageal squamous cell carcinoma

Conditions: Esophageal Cancer

Summary: to evaluate the predictive value and mechanism of inflammatory factors in peripheral blood on the prognosis of patients, and to explore the influencing factors of inflammation and tumor microenvironment on the efficacy of neoadjuvant chemotherapy combined with immunotherapy for esophageal cancer. to explore the predictors of neoadjuvant therapy in patients with esophageal squamous cell carcinoma.

patients with esophageal cancer admitted to hubei provincial people's hospital from may 2023 to december 2024 were collected (the estimated number of patients included is 60). collect research objects: 1. baseline information: gender, age, tumor location, t stage, n stage, and bmi, etc. the tumor staging and grading are determined according to the eighth edition of american joint committee on cancer esophageal cancer staging; 2. laboratory data; blood routine, liver and kidney function, electrolyte, coagulation function, tumor markers and cytokines were collected before neoadjuvant chemotherapy combined with immunotherapy, after 2 cycles of treatment and after 4 cycles of treatment (if applicable). after every two cycles of treatment, the remission status of the disease was evaluated by ct or gastroscopy in the routine treatment. to evaluate the predictive value and mechanism of peripheral blood inflammatory factors on the prognosis of patients, and to explore the influencing factors of inflammation and tumor microenvironment on the efficacy of neoadjuvant chemotherapy combined with immunotherapy for esophageal cancer.

Eligibility criteria:
inclusion criteria： the patient's age between 18 to 80 years old; esophageal squamous cell carcinoma with definite pathological diagnosis and ii-iva clinical stage preoperative neoadjuvant chemotherapy combined with immunotherapy the score of eastern cooperative oncology group is 0 \~ 1 exclusion criteria the estimated survival time is less than 6 months; the first diagnosis had distant metastasis suffering from malignant tumor or accompanying malignant disease in the past 5 years pregnant or pregnant women. vulnerable groups (those without informed ability, minors, vagrants, students and subordinates of researchers, employees of bidders)

Keywords: neoadjuvant therapy immunotherapy overall survival efficacy safety
a study of nivolumab plus brentuximab vedotin in patients between 5 and 30 years old, with hodgkin's lymphoma (chl), relapsed or refractory from first line treatment

Conditions: Hodgkin Disease

Summary: the purpose of this study is to determine whether nivolumab plus brentuximab vedotin (followed by brentuximab vedotin plus bendamustine in patient with suboptimal response) is safe and effective in treating patients with hodgkin's lymphoma (chl). eligible patients are children, adolescents, and young adults relapsed or refractory to first line.


Eligibility criteria:
inclusion criteria: * classic hodgkin lymphoma (chl), relapsed or refractory * minimal limitation on activities of daily living as measured by karnofsky ≥ 50 for participants \> 16 years of age or lansky ≥ 50 for participants ≤ 16 years of age. * one prior anti-cancer therapy that did not work exclusion criteria: * active, known, or suspected autoimmune disease or infection * active cerebral/meningeal disease related to the underlying malignancy * more than one line of anti-cancer therapy or no treatment at all * received a stem cell transplant for hodgkin lymphoma and/or a solid organ transplant * prior treatment with any drug that targets t cell co-stimulation pathways (such as checkpoint inhibitors) other protocol defined inclusion/exclusion criteria apply
evaluation of accuracy of one-step nucleic acid amplification (osna) in diagnosis of lymph node metastases of papillary thyroid carcinoma

Conditions: Papillary Thyroid Cancer; Lymph Node Metastases

Summary: the incidence of node metastases in papillary thyroid carcinoma (ptc) is high, ranging from 20% to 90%. prophylactic central lymph node compartment dissection (clnd), suggested from the latest guidelines for high-risk tumors, meets resistance due to the high incidence of postoperative complications. recently, new molecular biologic techniques, such as one step nucleic acid amplification (osna), have spread widely, allowing to quickly isolate, amplify and quantify mrna encoding for proteins selectively present in neoplastic cells, as cytokeratine-19. the aim of this study is to evaluate the application of osna to intraoperative diagnosis of node metastases of ptc.

papillary thyroid carcinoma (ptc) is the most common malignant thyroid neoplasm; it originates from follicular cells of thyroid gland, and represents over 80% of thyroid tumors. the incidence of ptc has progressively been increasing in the last decades, doubling since the 1970s, due to the diffusion of screening ultrasound. although ptcs are considered slow-growing tumors, the incidence of node metastases is high, ranging from 20% to 90%. the real impact of node metastases on prognosis is still a matter of debate: reports in literature demonstrate a reduction of disease-free survival but are divergent on overall survival. diagnostic tools have poor accuracy for central lymph node compartment, which is the most frequent site of metastases. the last guidelines suggest a prophylactic central lymph node compartment dissection (clnd) in patients with high-risk ptc; nevertheless, this indication meets resistance due to the higher incidence of postoperative complications, especially hypoparathyroidism and recurrent laryngeal nerve (rln) palsy. recently, new molecular biologic techniques have spread widely, mainly in diagnosis of node metastases in breast carcinoma; these assays allow to quickly isolate, amplify and quantify mrna encoding for proteins selectively present in neoplastic cells, as cytokeratine-19 (ck-19). one step nucleic acid amplification (osna) is routinely used in diagnosis of node metastasis in sentinel lymph node (snl) of patients affected from breast cancer. the aim of this study is to evaluate if application of osna to intraoperative diagnosis of node metastases of ptc is possible.

Eligibility criteria:
inclusion criteria: preoperative diagnosis of thyroid carcinoma exclusion criteria: -
study to evaluate safety and efficacy of dutogliptin in type 2 diabetes mellitus subjects with moderate and severe renal impairment

Conditions: Type 2 Diabetes Mellitus; Renal Impairment

Summary: the purpose of this study is to assess the safety and tolerability of dutogliptin in type 2 diabetic subjects with moderate or severe renal impairment.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * renal impairment (moderate and severe) * currently on stable doses of background medication of su, tzd, acarbose, meglitinide, insulin or any combination thereof, or on no antidiabetic drugs at all * hba1c 7.0% - 10.5%, inclusive * male or female subjects between the ages of 18 and 85 years, inclusive. exclusion criteria: * type 1 diabetes mellitus or history of diabetic ketoacidosis, mature onset diabetes of the young (mody) * kidney transplant

Keywords: diabetes dpp4 inhibitor dutogliptin phx1149
effects of vitamin d and calcium on hyperglycemia and dyslipidemia in patients gestational diabetes

Conditions: Diabetes Mellitus, Gestational

Summary: gestational diabetes mellitus (gdm) is becoming more common globally as a metabolic disease that occurs during pregnancy and influences the mother and the fetus. it has been linked to preeclampsia, c-section, and a higher lifetime risk of developing type 2 diabetes both for mother and the child. another complication of gdm is dyslipidemia that also accentuates cardiovascular risks, so the care of lipid profiles is essential for the best pregnancy outcomes. the previous literature review indicates that micronutrients including vitamin d and calcium have a bearing on glucose and lipid profiles. various studies have established that vitamin d improves the insulin response and lipid profile whereas calcium is vital in insulin and glucose homeostasis. furthermore, it is revealed that calcium induces vitamin d so that it could undergo its full metabolic effect. hence, the addition of vitamin d and calcium together may enhance glycemic management and lipid profiles of gdm patients. the aim of the present work is to compare the impact of vitamin d and calcium supplementation on lipid profiles and hyperglycemia in gdm patients. it will measure the major metabolic indices fasting plasma glucose, glycated hemoglobin (hba1c) and lipid profile (ldl, hdl triglycerides) and review the effect of this on pregnancy outcomes. these outcomes will be assessed by a randomized-controlled trial.

a randomized controlled trial study design will be used to assess the efficacy of vitamin d and calcium supplementation in lipid profiles and glycemic index among women with gdm. the sample for the study will consist of 60 pregnant women diagnosed with gdm, aged 18-40 years, and between 24-28 weeks of gestation. recruitment of participants will be done in antenatal clinics linked to \[lady willingdon hospital lahore\]. the diagnosis of gdm will be performed according to the results of ogtt following the international criteria. participants will be randomly divided to one of two groups: * intervention group: this group will receive 600 iu of vitamin d3 and 1.5-2 g of calcium daily for 6 weeks. * control group: this group will receive a placebo containing no active ingredients. for randomization, a computer-generated sequence will be used to randomly assign participant into the intervention arm or the placebo arm. the study will be conducted as double blind; the participants and the researchers shall not know the group allocations.

Eligibility criteria:
inclusion criteria: * pregnant women aged 18-40 years. * gestational age between 24-28 weeks. * diagnosis of gdm based on ogtt results. * willingness of participants to provide written informed consent. exclusion criteria: * pre-existing diabetes mellitus (type 1 or type 2). * chronic kidney or liver disease. * use of vitamin d or calcium supplements in the last 3 months. * multiple pregnancies (twins, triplets). * any major pregnancy complications (e.g., preeclampsia).

Keywords: hyperglycemia lipid profiles pregnancy outcomes
cns infections effect on the inner ear

Conditions: CNS Infection; Inner Ear Hearing Loss; Vestibular Abnormality; Inner Ear Inflammation; Hearing Loss, Sensorineural

Summary: study on patients with cns infections.

aims and objectives: the present proposal aims to improve the outcome from central nervous system infections (cns) by improving the understanding of when and why patients develop hearing loss and other neurological sequelae. the investigators will elucidate the temporal development and restitution of a sensorineural hearing loss and will clarify if any therapeutic window exists, where sequelae can be limited. also the investigators will investigate if communication between cochlea and cerebrospinal fluid is a window to the intracranial pressure. background: cns infections remain diseases with high mortality and morbidity. among survivors from bacterial meningitis, 30 % suffer hearing loss or deafness arising from injury to the inner ear - the cochlea. from previous work it is known that brain inflammation, brain edema and subsequent pressure changes can be transduced to the inner ear due to communication between the cochlea and cerebrospinal fluid (csf). the viability of cochlear hair cells can evaluated by non-invasive measurement of otoacoustic (oae) emissions which are low-intensity sounds from the cochlea (oae). methods and materials: the investigators will perform repeated measurements of oae and wide band tympanometry (wbt) in all patients admitted with suspicion of a cns infection. oae and wbt will be compared to intracranial pressure (icp) measured during lumbar puncture as well as clinical-, biochemical- and imaging data. an age-matched control group will be included. at discharge and at follow-up patients will receive a neurological, vestibulare examination, cognitive test and a regular hearing test. expected outcome and perspectives: from repeated measures during a course of disease, the investigators will elucidate the development of a hearing loss and clarify if any therapeutic window exists, where sequelae can be limited. this is also an opportunity to assess oae as a non-invasive measure of intracranial pressure which is believed to be among the clinical complications responsible for a poor outcome.

Eligibility criteria:
inclusion criteria: * patients with a cns infection admitted to the hospital. exclusion criteria: * patients with known hearing loss