Kornimate/medical-research-clean huggingface dataset:
pass oct® post-market clinical follow-up

Conditions: Intervertebral Disc Disease; Spondylolisthesis; Spinal Stenosis; Spinal Neoplasms; Spinal Fractures

Summary: prospective, multicenter non comparative and observational study (post-market clinical follow-up). patients operated with pass oct® manufactured by medicrea® international between july 2016 and july 2017. the inclusion period will be 12 months and the follow-up 24 months

the primary endpoint is to evaluate the safety of the pass oct® system. the secondary endpoints are to analyze the efficacy of the system with several point of view: * the quality of fusion and the time of fusion through x rays * the pain with vas * the quality of life thanks to questionnaires: ndi (neck disability index) and joa for myelopathy * the daily of the patient: return to work, sport * the surgeon satisfaction.

Eligibility criteria:
inclusion criteria: * patient with * degenerative disc disease or, * spondylolisthesis, or * spinal stenosis, or * trauma, or * atlanto-axial fractures with instability or * cervical tumors. * patient operated with pass oct® * patient \> 18 years * patient affiliated to health care insurance (social security in france) * patient able to complete a self-administered questionnaire * patient able to understand the protocol and the planning visit * patient able to sign an informed consent form exclusion criteria: * patient unable or unwilling to sign an informed consent form * patient unable to complete a self-administered questionnaire * pregnant patient or intending to get pregnant within the next 3 years * patient judged as non-compliant by the investigator or not able to come back for follow-up visits
adenomyosis and pregnancy: levonorgestrel vs. gnrh for blastocyst transfer

Conditions: Adenomyosis

Summary: adenomyosis is a condition where endometrial tissue grows into the uterine muscle, causing symptoms like pelvic pain, heavy bleeding, and infertility. this abnormal growth can lead to a variety of reproductive issues, including a higher risk of miscarriage and early pregnancy loss. while there are treatments available for adenomyosis, they are often limited due to the lack of precise diagnostic criteria. one common approach is the use of gonadotropin-releasing hormone agonist (gnrha), which can improve pregnancy rates in infertile women with adenomyosis. however, it's important to note that gnrha may not restore pregnancy rates to baseline levels. another potential treatment option is the levonorgestrel-releasing intrauterine system (lng-ius). this device releases a hormone called levonorgestrel into the uterus, which can help control the symptoms of endometriosis and adenomyosis. studies have shown that the endometrial concentration of levonorgestrel from the lng-ius is significantly higher than in other tissues like the myometrium, fallopian tubes, and fat tissue.


Eligibility criteria:
inclusion criteria: * women who have adenomyosis diagnostic characteristics and underwent icsi that resulted in good-quality fe. exclusion criteria: * women women who have adenomyosis diagnostic characteristics and underwent icsi that resulted in poor-quality fe.
this is a multicenter, prospective and retrospective and descriptive epidemiology study in patients with chronic obstructive pulmonary disease (copd) in korea

Conditions: COPD

Summary: this study is designed as a multicenter, prospective and retrospective and descriptive epidemiology study. this study is planned to evaluate 2 years of exacerbation in copd patients and to investigate correlation of copd disease progress and its exacerbation. this study is designed with 6 months of subject enrollments, 12 months of retrospective study, and 12 months of prospective study. hence, each patient will be participating in the study for 12 months, while the actual data collections from the patients will take a total of 24 months. the statistical analysis of this study will be done twice, at the completion of 1 year retrospective data collection and at the completion of next 1 year follow-up. the 1st statistical analysis of retrospective study includes exacerbation rate, duration of hospitalization for exacerbation and lung function test for the past 1 year from the enrollment and comorbidities, copd assessment (cat) and copd medication at the enrollment will be analyzed. the 2nd statistical analysis of prospective 1-year follow-up includes changes in exacerbation rates, comparison of lung function test results, comorbidities, copd assessments (cat) and copd medications of retrospective and prospective studies for the 2 years as well as mortality rate.


Eligibility criteria:
inclusion criteria: 1. over 40 years old 2. patient with at least 1 year of medical history of copd as defined by gold criteria 3. patient with having past 1 year medical record at the investigational site 4. patient who signed informed consent form exclusion criteria: 1. patients who are currently involved in any other interventional studies or possible to be involved for the next 1 year 2. patients currently diagnosed with cancer

Keywords: copd exacerbation rate
the picm risk prediction study - application of ai to pacing

Conditions: Heart Failure; Pacemaker-Induced Cardiomyopathy; Pacemaker Complication

Summary: development of pacing induced cardiomyopathy (picm) is correlated to a high morbidity as signified by an increase in heart failure admissions and mortality. at present a lack of data leads to a failure to identify patients who are at risk of picm and would benefit from pre-selection to physiological pacing. in the light of the foregoing, there is an urgent need for novel non-invasive detection techniques which would aid risk stratification, offer a better understanding of the prevalence and incidence of picm in individuals with pacing devices and the contribution of additional risk factors.

retrospective review of patient characteristics including 12 lead resting electrocardiograms and imaging data (cmr, ct, echo, cxr and fluoroscopy of pacing leads) of patients with right sided ventricular pacing lead due to symptomatic bradycardia, who developed pacing induced cardiomyopathy (or need for crt upgrade) versus patients who did not using supervised machine learning methods. development of personalised predictive pacing algorithm to improve right ventricular lead placement, such as conduction system pacing or pre-emptive implantation of an additional left ventricular lead to prevent left ventricular dilatation and pacemaker-induced cardiomyopathy (picm) with heart failure (left ventricular ejection fraction \<50% by simpson method), hospitalisation or death with the use of the retrospective patient data through machine learning.

Eligibility criteria:
inclusion criteria: * all patients who received a pacing device (vvi, ddd, icd, leadless pacemaker) from the gstt/rbh/kch/ich database in the last 10 years (from 01/01/2014) * all patients who are \>18 years old. * male and female exclusion criteria: * patients who did not receive a pacing device (vvi, ddd, icd, leadless pacemaker) * all patients \<18 years old * patients with congenital heart disease * patients who have received artificial heart valves or underwent cardiac bypass surgery * patients who did not have an echocardiogram after receiving a pacing device
early lung rehabilitation care for patients after double lung transplantation

Conditions: Pulmonary Disease

Summary: develop appropriate individual programs for patients to implement lung rehabilitation safely and effectively.

early respiratory function training, reasonable oxygen therapy to prevent hypoxemia, positive pressure vibration training to promote coughing ability recovery, early exercise, health education and psychological support.

Eligibility criteria:
inclusion criteria: * patients after double lung transplantation; informed consent exclusion criteria: * unstable condition
prescription of valproate and derivatives in women of childbearing age: qualitative study

Conditions: Psychiatric Disorder

Summary: the prescription of valproate in women of childbearing age has decreased by 82% in france, for mood disorders. exposure to valproate during pregnancy 60%. however, the ansm sent an alert document in august 2022 because there are still patients on valproate. in addition, there were 32 births taking valproate to mothers with bipolar disorder in 2018. the risks of exposure during pregnancy which occur in 10% of exposure cases are: congenital malformations; neurodevelopmental disorders including autism spectrum disorders, attention deficit disorders more or less hyperactivity, language disorders, motor disorders, mental delays; reduction in social, attentional, motor and language abilities; a lower level of education.


Eligibility criteria:
inclusion criteria: * subject (≥16 years old) * female gender * prescription of valproate and/or derivatives (sodium divalproate, valpromide, valproic acid, sodium valproate) in an indication of psychiatric disorder for the period from january 1, 2021 to december 31, 2022, * subject not opposing, after information, the reuse of their data for the purposes of this research * holders of parental authority who do not object, after information, to the reuse of their child's data for the purposes of this research exclusion criteria: * subject and/or holder of parental authority having expressed opposition to participating in the study * impossibility of providing the subject with informed information (difficulties in understanding the subject, etc.)

Keywords: psychiatric disorder valproate
study to investigate the safety, tolerability and pharmacokinetics of azd1386

Conditions: Chronic Pain

Summary: the study is being performed in order to learn more about the safety and tolerability of azd1386. azd1386 is primary intended for treatment of chronic pain.


Eligibility criteria:
inclusion criteria: * healthy caucasians, males or females aged ≥20 and ≤ 45 years or between 65 80 years. female subjects must be surgically sterile or post-menopausal for at least 12 months prior to the enrolment visit. * body mass index (bmi) of ≥18 to ≤ 30 kg/m2 and weight of ≥50 to ≤100 kg * clinically normal physical findings including heart rate \> 45 bpm and laboratory values and normal resting ecg exclusion criteria: * history of somatic or psychiatric disease/condition, which may interfere with the objectives of the study. * history of severe allergy/hypersensitivity or symptoms/signs of ongoing allergy/hypersensitivity. * subjects with a high decrease in blood pressure within 5 minutes when going from a supine to standing position.

Keywords: mad multiple ascending dose chronic pain pain
a study using subject-specific mrd to adopt treatment after hsct for subjects with mds

Conditions: Myelodysplastic Syndromes; Acute Myeloid Leukemia With Myelodysplasia Related Disease and < 30% Blasts; Mixed Myelodysplastic/Myeloproliferative Disease

Summary: the goal of this interventional study is to evaluate if pre-emptive intervention using azacitidine and / or donor lymphocytes or tapering of immune suppression in measurable residual disease (mrd) positive subjects can prevent clinical relapse. participants will undergo mrd surveillance and be subjected to intervention in case of mrd positivity. results will be compared with nmdsg14b, part one, in which mrd was analyzed in included patients without recieving intervention.


Eligibility criteria:
inclusion criteria: signed informed consent * age ≥ 18 years * subjects eligible for sct * subjects having the disease mds, mixed myelodysplastic/myeloproliferative syndrome or aml with myelodysplasia related dysplasia and 20-29% marrow blasts * all female subjects of childbearing potential have to have negative pregnancy test within 2 weeks prior to inclusion to the study exclusion criteria: * no traceable genetic aberration identified either in screening next generation sequencing panel or next generation sequencing panel performed at diagnosis * uncontrolled hypertension, heart, liver, kidney related or other uncontrolled medical or psychiatric disorders * mental inability, reluctance or language difficulties that results in difficulty understanding the meaning of study participation
a study to evaluate the immune response to the asp7373 and its safety in healthy adult volunteers

Conditions: Healthy

Summary: this trial is to investigate the clinically recommended dosage for asp7373 based on the comparison of the immunogenicity and safety among the three doses of asp7373 in healthy adults.


Eligibility criteria:
inclusion criteria: * body weight: female: ≥40.0 kg, \<70.0 kg, male: ≥50.0 kg, \<80.0 kg * bmi: ≥17.6, \<26.4 * healthy, as judged by the investigator or sub-investigator based on the results of physical examinations (subjective symptoms and objective findings) and all tests obtained exclusion criteria: * scheduled to receive another vaccine during study period * history of h5 influenza infection or received h5 influenza vaccine * past history of anaphylactic shock or an allergic reaction such as generalized eruption due to food or drug (including vaccines) allergies, fever ≥ 39.0°c within 2 days after the previous vaccination (influenza vaccine and others) * diagnosis of immune deficit in the past, has a family member (within the third degree of kinship) with a diagnosis of congenital immunodeficiency syndrome * received or scheduled to receive a live vaccine within 28 days prior to vaccination of the study vaccine, and received or scheduled to receive an inactivated vaccine or a toxoid within 7 days prior to vaccination of the study vaccine * history of seizures * female subjects who are breastfeeding, pregnant, possibly pregnant, and planning to become pregnant during the study period

Keywords: recombinant influenza ha vaccine immunogenicity of asp7373
dynamic thoracic impedance as a marker for heart failure decompensation

Conditions: Heart Failure; With Decompensation

Summary: this pilot study proposes to perform measurements of approved thoracic impedance technology that will help answer questions in patients with decompensated heart failure.

improved metrics derived from the transthoracic impedance (z) available from implanted medtronic devices may provide more sensitive indicators of the state of compensation for heart failure patients. quantification of specific data may provide new information that can improve quality of life for patients and offer vital information to clinicians regarding the adequacy of inpatient and outpatient assessment and management of acute decompensated heart failure.

Eligibility criteria:
inclusion criteria: * patients with systolic dysfunction * able to provide informed consent * have a medtronic manufactured device with thoracic impendence monitoring capabilities exclusion criteria: * patients with severe congestive heart failure who are intubated * patients who are oxygen dependent on continuous positive or bilevel positive ventilation * inability to tolerate postural variations due to congestive heart failure or other medical or surgical condition.unable to complete proposed testing * subjects who cannot givewill not give written, informed consent on their own behalf

Keywords: thoracic impedance diagnostic marker bed rest test transthoracic impedance heart failure hf
a study of whole brain radiation therapy and capecitabine in breast cancer participants with newly diagnosed brain metastasis

Conditions: Breast Cancer

Summary: this open-label, randomized, parallel arm study will evaluate the effect of capecitabine administered concurrently with wbrt and as maintenance therapy in participants with breast cancer and newly diagnosed brain metastases. participants will be randomized to receive either capecitabine with 10 days standard wbrt, or wbrt alone. maintenance therapy will follow with capecitabine or another systemic therapy in the wbrt only group.


Eligibility criteria:
inclusion criteria: * women with histologically confirmed breast cancer with known human epidermal receptor-2 (her2) and hormone status * newly diagnosed cns metastasis with at least one brain lesion measuring greater than or equal to (\>/=) 1 centimeter (cm) or two lesions measuring \>/= 0.5 to less than (\<) 1 cm in longest dimension * participant not eligible for or refusing surgery or stereotactic radiosurgery * eastern cooperative oncology group (eocg) performance status 0 to 2 exclusion criteria: * prior treatment of brain metastases * leptomeningeal disease * known contra-indication to radiotherapy or magnetic resonance imaging (mri) or capecitabine
efficacy of parecoxib on patients with crps

Conditions: Causalgia

Summary: the complex regional pain syndrom is a weighty disease that often results in a lifelong disability. mostly this disease appears unilateral after comparatively mundane fractures or operations. in early stages crps shows inflammatory processes. these inflammatory components can be seen as edema and vasodilatation. these inflammatory processes lead us to the hypothesis that selective cox-2-inhibitors might help patients with crps.


Eligibility criteria:
inclusion criteria: * patients with saved diagnosis of crps of the upper extremity based on the current used criteria for diagnosis plus a positiv 3-phase-sceletal-scintilgraphy, if they show pathological ppt-values in qst on the ipsilateral site (z-values \> 2 in age- and gender-based z-transformation of the raw values)• age ≥ 18 years• existence of an age-based normal creatinin-clearance (calculated with a defined formula) exclusion criteria: * important cardiovascular illness for the purpose of heart failure (nyha ii - iv), coronary heart disease (chd), peripheral artery occlusive disease (paod) or unstable hypertension (values constantly over 140/90 mm hg) * florid kidney disease * cerebral disease * neurological systemic disorder (exception: beginning polyneuropathy with normal values of the ppt on the opposite side) * lesion of the median nerve (ipsi- oder contralateral) * acute bleeding disease * known ulcer of the stomach or duodenum * inflammatory bowel disease * positive anamnesis of a gastrointestinal bleeding in the last 5 years * important hepatic dysfunction (child- pugh \> 9) * hypersensitivity to the agent or to sulfonamides * known allergy to acetylsalicylic acid, nonsteroidal antiinflammatory drugs or other selectiv cyclooxygenase-inhibitors * pregnancy and lactation period * intake of one of the following drugs (current or in the last 3 days) * selective-serotonin-reuptake-inhibitor * cetoconazole * rifampicin * phenytoin * carbamazepine * dexamethasone or other systemic corticoids * traditional nonsteroidal antiphlogistics * cyclooxygenase-inhibitors * immunsupressives * tnf-α-inhibitors

Keywords: causalgia crps complex regional pain syndrome dynastat parecoxib
acupressure in hyperemesis gravidarum

Conditions: Hyperemesis Gravidarum

Summary: to examine the degree of nausea, vomiting between the acupressure and control group in women with hyperemesis gravidarum

a prospective rct conducted at department of obst and gynae, ukmmc. all pregnant women with a normal intrauterine pregnancy of ≤ 16 week gestation with hyperemesis gravidarum will be assessed by the medical officer/ specialist/ consultant in charge. explanation regarding the research study will be given for patients who fulfill the inclusion and exclusion criteria. patients who have understood the research study and consented will be recruited as subjects for the study.

Eligibility criteria:
inclusion criteria: 1. onset of vomiting before 16 weeks 2. vomiting at least 2 times per day 3. ketonuria on admission 4. mid stream urine specimen that did not indicate infection exclusion criteria: 1. non viable pregnancy 2. molar pregnancy 3. overt clinical features of thyrotoxicosis 4. known case of medical illness that associated with nausea and vomiting 5. patient refusal or patients who are not able to give consent
systemic oxidative stress score as a predictor of gastric cancer survival and recurrence risk

Conditions: Gastric Cancer

Summary: the systemic oxidative stress score (soss) , a comprehensive score reflecting the oxidative stress conditions in the microenvironment, can independently and effectively predict tumor burden and long-term prognosis in gc patients. nomograms based on soss provide a potential and promising model for risk stratification and guiding the implementation of treatment decisions.

we retrospectively analyzed the clinical data of gastric cancer patients who underwent radical gastrectomy in three hospitals from january 2009 to june 2020. the data from one hospital were randomly divided into a training cohort and an internal validation cohort in a 7:3 ratio, while the data from the other two centers were used as an external validation cohort. in the training cohort, cox proportional risk models were employed to identify key indicators of soss and independent prognostic factors influencing patients' os and dfs. subsequently, based on the results of the multifactor cox analysis, two predictive models for os and dfs were developed. the predictive efficacy, calibration, and clinical utility of the models were evaluated using roc curves, calibration curves, and decision curves in the internal and external validation cohorts, respectively. both models demonstrated good discriminative ability between postoperative survival and recurrence risk, outperforming tnm staging in terms of predictive accuracy.

Eligibility criteria:
inclusion criteria: 1) gastroscopic histopathological diagnosis of gastric adenocarcinoma; 2) radical gastrectomy for gc; 3) preoperative examination of oxidative indicators including fbg, chol, alb, tbil, dbil, and cr within seven days before surgery; and 4) the tumor did not invade neighboring organs or had no distant metastasis. exclusion criteria: 1) gastroscopic histopathological diagnosis of non-adenocarcinoma, 2) gastric stump cancer, 3) neoadjuvant chemotherapy, 4) other malignant diseases besides gc, 5) incomplete medical records, and 6) patients with gc lost to follow-up.

Keywords: oxidative stress gastric cancer recurrence disease-free survival systemic oxidative stress score