Kornimate/medical-research-clean huggingface dataset:
investigation of the timely-coordinated therapy of patients with metastatic cancer by radiotherapy together with immune checkpoint inhibition

Conditions: Metastatic Cancer

Summary: immunotherapy for the treatment of several cancer entities steadily increased during the last years. the data from the finalized and ongoing studies show the tremendous impact of immune checkpoint inhibition (ici) also for advanced metastatic patients. especially the ici with pembrolizumab and nivolumab have an increasing number of first line treatment approvals. however, in particular metastatic patients which receive ici therapy are often irradiated for immediate palliation of several metastases. preclinical work revealed that radiotherapy (rt) is capable to modulate the tumor phenotype, its microenvironment in a way that systemic anti-tumor immune responses are induced. however, radiation has also immune suppressive properties as e.g. the expression of immune checkpoint molecules is increased following radiotherapy. so the ici therapy in combination with the rt has the potential to overcome the immunotolerance of the tumor and the metastases. more and more reports therefore describe a so-called systemic immune-modulating effect of radiotherapy (former and still often named as abscopal effect). however the timely application of ici and rt is often randomly and depends on the clinical need for the palliative rt. the aim of this trial is therefore to standardize the chronology of rt in combination with ici, to evaluate the effects of radio-immunotherapy with a stratified and comparable patient cohort. the st-ici study is a prospective and observational study not influencing the standard therapeutic scheme and will provide hints how the radio-immune therapy drives systemic anti tumor responses.


Eligibility criteria:
inclusion criteria: * patients suffering and diagnosed for: metastatic cancer of several entities * clinical indicated therapy with pd-1/pd-l1 inhibitors or ctla-4 antagonists * optionally radiotherapy if clinically indicated * age at least 18 years exclusion criteria: * fertile patients who refuse effective contraception during study treatment * persistent drug and/or alcohol abuse * patients not able or willing to behave according to study protocol * patients in care * patients that are not able to speak german * patients which are imprisoned according to legal or governmental order

Keywords: metastatic cancer radiotherapy immunotherapy radioimmuno therapy
the construction and application of therapeutic system of intelligent decision-oriented hemodynamic organized therapy for shock patients

Conditions: Septic Shock

Summary: patients with septic shock with norepinephrine \>0.25ug/kg/min were enrolled. informed consent was obtained for inclusion in the study and random assignment into the combination or norepinephrine group. contact the research assistant to obtain patient number information and print out the appropriate labels.notify the ward dispensing nurse to open the experimental drug cassette (placed in the refrigerator 4℃ drug cabinet). extract the corresponding experimental medication according to the patient label number, dispense it and send it to the ward, label it and hand it over to the bedside nurse to start using it. the time point at which the medication was connected to the patient and activated was recorded as the zero point for the start of the study. the data were monitored according to the time points specified in the study: baseline,0h , 6h, d1, d2, and post-drug withdrawal.


Eligibility criteria:
inclusion criteria: septic shock patients with norepinephrine\>0.25ug/kg/min exclusion criteria: 1. under 18 years of age 2. acute coronary syndrome requiring treatment 3. have been treated with va-ecmo 4. vv-ecmo treatment has been administered for less than 12 hours 5. patient is on posterior pituitary hormone 6. patients with liver failure with a model for end-stage liver disease (meld) score ≥ 30 7. patients requiring more than 500 mg of hydrocortisone or equivalent glucocorticoid daily as a fixed dose 8. absolute neutrophil counts below 1,000/mm3 9. patients with active bleeding who are expected to require (within 48 hours of study entry) transfusion of more than 4 units of red blood cell concentrate patients with active bleeding that is expected to require (within 48 hours of study entry) transfusion of more than 4 units of red blood cell concentrate 10. malignancy or other irreversible disease or condition with an estimated 6-month mortality rate of ≥50% 11. confirmed or suspected acute mesenteric ischemia. if the investigator believes that the patient's condition is highly suspicious but not confirmed by conventional criteria the investigator may exclude a patient if, in the opinion of the investigator, the patient's condition is highly suspicious but not confirmed by conventional criteria, or if the treating physician has initiated empiric therapy. 12. likely death expected within 12 hours 13. family or physician plans to implement a palliative care plan for the patient

Keywords: norepinephrine, vasopressin, organ perfusion.
comparative evaluation of ambu auragain laryngeal mask and proseal laryngeal mask airway

Conditions: Laryngeal Masks

Summary: comparison of two different supraglottic airway devices i.e., the proseal laryngeal mask airway (plma) and ambu auragain, a third generation laryngeal mask airway.

the study aims to compare the two devices with respect to: time taken for insertion. insertion attempts or failed attempt. oropharyngeal leak pressure air leak time taken to pass an orogastric tube attempts to pass an orogastric tube or failed attempt. haemodynamic variation incidence of adverse events like failed insertion, aspiration-regurgitation, hypoxia (spo2\< 90%), bronchospasm, airway obstruction, gastric insufflation, coughing, gagging, retching, hiccup, coughing during removal, blood staining of the airway device and trauma to tongue, lip, teeth, or gums.

Eligibility criteria:
inclusion criteria: 1. american society of anesthesiologists (asa) physical status i \& ii 2. patients undergoing limb or breast surgery 3. patients undergoing elective surgery under general anesthesia and spontaneous ventilation. 4. patients with expected duration of surgery of less than 2 hours. exclusion criteria: 1. patients with known or predicted difficult airway or mallampati grade (mpg) iii or iv 2. patients with mouth opening of less than 2.5 cm or cervical spine disease 3. patients with h/o upper respiratory tract infection in the previous 10 days. 4. patients with increased risk of regurgitation and aspiration (non-fasting patients, gastroesophageal reflux disease etc.) 5. patients with a body mass index (bmi) \> 30 kg/m2 6. patients with past history of radiotherapy involving the hypopharynx/neck area 7patients with expected duration of surgery of more than 2 hours. 8.surgery to be performed to the head, neck or thorax, abdomen or in the lateral or prone positions
comparison of two cognitive-motor rehabilitation approaches via exergames: a study of cognitive, motor and behavioral functions in huntington's disease patients

Conditions: Huntington&#39;s Disease (HD); Exergame

Summary: huntington's disease (hd) is a rare, hereditary neurodegenerative disorder. it generally manifests itself between the ages of 40 and 50, and results in motor impairment (choreic movements, balance disorders, gait disorders, etc.), cognitive impairment (executive functions, attention, etc.) and behavioral impairment (apathy, depression, irritability, etc.). to date, there is no curative treatment for hd, and drug therapies have little effect on symptomatology, particularly motor symptoms. physical activity and cognitive stimulation appear to be promising tools in the fight against the progression of various symptoms in certain progressive neurological conditions, including hd. in addition, the use of exergame as an interface is becoming increasingly widespread and offers encouraging prospects in the management of certain neurodegenerative diseases (parkinson's disease, multiple sclerosis, spinocerebellar ataxia type 3). the aim of our project is to carry out a preliminary evaluation of the clinical benefit of a management program combining physical activity and cognitive stimulation, compared with a sequential management program.


Eligibility criteria:
inclusion criteria: * adults at inclusion * huntington's disease diagnosed and confirmed by genetic analysis * patient with stage 1-2 hd with a motor uhdrs score ≥ 5 and a cft between 6 \< cft ≤ 13 * patient with written informed consent or third-party consent * affiliated or beneficiary of a social security scheme exclusion criteria: * poor understanding of the french language * participation in interventional research modifying management * history likely to interfere with cognition (established stroke, sequelae of traumatic brain injury, active epilepsy, learning disorders, alcohol dependence syndrome, drug use, psychiatric disorders), severe cognitive deficit (mmse \<16), clinically significant pathological condition which, in the investigator's opinion, could interfere with the subject's safety or the evaluation of study results * pregnant or breast-feeding women * persons deprived of their liberty by administrative or judicial decision * persons under compulsory psychiatric care
puzzle game strategy on older adults

Conditions: Old Age; Debility

Summary: one innovative approach uses puzzle game strategies, including crosswords, sudoku, and other brain-teasing activities. these strategies have been shown to help maintain attention, improve memory, and keep older adults' thoughts clear and sharp. additionally, engaging in these activities can provide psychological benefits by offering a sense of achievement, reducing stress, and fostering social interactions.

cognitive abilities naturally decline as people age, one factor leading to deteriorating psychological health among older adults. therefore, it is crucial to develop interventions to enhance this population's cognitive abilities and psychological well-being through non-pharmacological complementary treatments. such interventions should focus on improving these symptoms while replacing traditional therapies. one innovative approach uses puzzle game strategies, including crosswords, sudoku, and other brain-teasing activities. these strategies have been shown to help maintain attention, improve memory, and keep older adults' thoughts clear and sharp. additionally, engaging in these activities can provide psychological benefits by offering a sense of achievement, reducing stress, and fostering social interactions. given puzzle games' potential to enhance cognitive and psychological health, exploring their effectiveness as a non-pharmacological intervention for community-dwelling older adults is essential. this research aims to fill the gap by empirically investigating the impact of puzzle game strategies on cognitive functioning and psychological well-being in this demographic.

Eligibility criteria:
inclusion criteria: * aged 60 years and above. * able to communicate effectively. * have mild or moderate cognitive impairment, exclusion criteria: * have rheumatoid arthritis. * hand tremors that could limit their ability to use puzzles.
the efficacy of cryotherapy in pregnancy related pelvic girdle pain

Conditions: Pelvic Girdle Pain

Summary: the findings from this project may result in pain reduction and improved mobility in pregnant women with pelvic girdle pain in their second and third trimester.

the primary objective of this unblinded randomized controlled trial is to determine whether superficial cryotherapy results in improved numeric pain rating scale (nprs) scores among pregnant women with posterior pelvic girdle pain. the investigators hypothesize that superficial cryotherapy, in addition to receipt of an educational pamphlet, will result in improved nprs scores compared to receipt of an educational pamphlet alone. this study will include english-speaking pregnant women presenting to loyola university medical center obstetrics or rehabilitation clinics in their second or third trimester with posterior pelvic girdle pain, defined as an nprs score \> 2 onset within the past 3 months and pain experienced between the posterior iliac crest and the gluteal fold, particularly in the vicinity of the sacroiliac joints (sij). the pain may radiate in the posterior thigh and can also occur in conjunction with/or separately in the \[pubic\] symphysis. nprs scores will be measured as a continuous, numerical integer ranging from a value of 0 (no pain) to a value of 10 (worst possible pain).

Eligibility criteria:
inclusion criteria: * english speaking pregnant women presenting in their second or third trimester with acute posterior pgp (occurring within the last 3 months). trimester will be determined from the date of last menses or ultrasound date. * current vas pain score between 2-4 * written informed consent exclusion criteria: * non-english speaking pregnant women \ 50 years old * women presenting with low back pain, or posterior pelvic pain in the first trimester (\<13 weeks gestation). * women with acute low back pain in 2nd and 3rd trimester * women with anterior pelvic girdle pain (pubic symphysis) alone * chronic low back pain (current or past history, defined as \> 6 weeks of low back pain) * history of lumbar or pelvic fracture; degenerative disc disease; neoplasm; inflammatory disease; active urogenital infection or active gastrointestinal illness; previous surgery of the lumbar spine, pelvic girdle, hip joint or femur * history or signs of radiculopathy or other systemic neurologic disease * narcotic medication use
comparative effectiveness research to assess the use of primary prophylactic implantable cardioverter defibrillators in europe

Conditions: Coronary Artery Disease; Myocardial Infarction; Dilated Cardiomyopathy; Implantable Defibrillator User

Summary: the "european comparative effectiveness research to assess the use of primary prophylactic implantable cardioverter defibrillators (eu-cert-icd)" is a modular research project to study the effectiveness of prophylactic icds in a prospective study, a retrospective registry, and meta-analyses of existing evidence on the subject.

the prospective study part is an observational, prospective multi-centre study which aims to enrol 2500 patients with ischemic or dilated cardiomyopathy and primary prophylactic icd indication for reduced left ventricular ejection fraction (lvef) according to current guidelines. according to the treating physician's decision and preference which is independent from study participation, patients are recruited into one of two groups: patients directly prior to first icd implantation (icd group), or patients who are not considered for prophylactic icd treatment by the physician or are considered but refuse icd treatment (control group). patients will undergo simple 12-lead electrocardiogram (ecg) and holter ecg diagnostics at baseline as well as genetic biobanking at entry to the study. all patients will be subsequently followed for at least 1 year and up to 4 years. co-primary endpoints are all-cause mortality and appropriate icd shocks.

Eligibility criteria:
inclusion criteria: * ischemic or dilated cardiomyopathy and recommendation for primary prophylactic icd treatment following current international treatment guidelines * written informed consent * if icd implantation is planned, enrollment and study baseline testing needs to be completed before de-novo icd implantation exclusion criteria: * permanent atrial fibrillation or atrial fibrillation at baseline in case more than 15% of such patients at a given time have been enrolled * indication for secondary prophylactic icd treatment * indication or candidate for cardiac resynchronization therapy * av block ii°-iii° at resting heart rates * implanted pacemaker * unstable cardiac disease such as decompensated heart failure (nyha functional class iv) or acute coronary syndrome * participation in other clinical trials which exclude enrolment in other trials

Keywords: defibrillator, implantable cardioverter sudden cardiac death primary prophylaxis risk stratification
aeson tah system - post-market clinical follow-up study

Conditions: Heart Failure

Summary: the safety and performance of the aeson tah system have been demonstrated for the ce mark approval in december 2020. the purpose of this post-market clinical investigation is to confirm the safety, performance and effectiveness of the aeson tah system when used in routine care by surgeons.

the primary objective/endpoint is survival rate on the originally implanted aeson device at 90 days post-implant (h1 \> 64%). the second objectives/endpoints are: 1. confirm the performance and safety profile of the device for patients implanted with the aeson tah system until being transplanted: * survival at 6, 12, 18, and 24-months post-implant, and total support duration before transplantation; * health status change as measured by nyha classification, 6mwt and quality of life questionnaire (eq-5d-5l); * renal and hepatic function as measured by biological parameters; * hemocompatibility profile measured by biological parameters and incidence of hemocompatible-related adverse events; * frequency and incidence of serious adverse events. 2. assess the effectiveness of device upgrades 3. confirm the safety profile of the device for patients after being transplanted. * survival at 30 days, 6 months, and 12 months post-transplant * frequency and incidence of serious adverse event of special interest as graft reject, neurological events, major bleeding.

Eligibility criteria:
inclusion criteria: * patient is intended to receive an aeson tah system according to the ifu indications within standard medical practice * patient has provided written informed consent using the ethics committee approved consent form non-inclusion criteria: * vulnerable populations who could not voluntarily consent to participate in the study

Keywords: advanced heart failure total artificial heart bridge to transplant
pulmonx endobronchial valves used in treatment of emphysema (liberate study)

Conditions: Emphysema

Summary: the purpose of this research is to study an investigational medical device that is designed to produce lung volume reduction in diseased areas of the lungs in patients with severe emphysema.

the pulmonx zephyr endobronchial valve (ebv) is an implantable bronchial valve intended to decrease volume in targeted regions of the lung. it is indicated for the treatment of patients with severe emphysema. the ebv are placed in the diseased region of the lung using bronchoscopy. bronchoscopy is a way to access the lungs using a small tube with a camera on the end. as the diseased region of the lung shrinks in size, healthier regions may expand and function more efficiently, resulting in improved breathing. the liberate study is a clinical trial with two groups. participants are assigned at random to the 'treatment' group or to the 'control' group. the 'treatment' group will receive the zephyr endobronchial valve (ebv) in combination with optimal medical therapy. the 'control' group will receive optimal medical therapy alone. for every three participants in the study, two will go into the 'treatment' group and one will go into the 'control' group. it is hypothesized that after placement of the ebv, lung function will be improved as compared to standard medical therapy alone. based on the 12-month follow up data from the liberate study, the zephyr endobronchial valve system was approved by the fda for the treatment of severe emphysema in june 2018. following this pma approval, and in agreement with the fda, the ongoing long term follow-up (out to 5 years) of patients in the liberate study will now be conducted as a post-approval study under the auspices of the "liberate extension study". this is an administrative change with absolutely no change to the design or conduct of the study and, therefore has no material impact to the study participants or the study sites. all annual follow-up visits and evaluations are per the original liberate study protocol. reporting to the fda will be as the liberate extension study.

Eligibility criteria:
inclusion criteria: * clinical and radiological evidence of emphysema * nonsmoking for 4 months prior to screening interview * bmi less than 35 kg/m2 * stable on current medication regimen * forced expiratory volume in one second (fev1) between 15% and 45% of predicted value * residual volume less than 175% predicted (determined by body plethysmography) * little or no collateral ventilation (cv-) as determined using the chartis system exclusion criteria: * had two or more hospitalizations over the last year for a copd exacerbation * had two or more hospitalizations over the last year for pneumonia * had a prior lung transplant, lung volume reduction surgery, bullectomy or lobectomy * had a heart attack or congestive heart failure within the last 6 months * have heart arrhythmia * is alpha-1 antitrypsin deficient

Keywords: emphysema endobronchial valve treatments pulmonary rehabilitation lung volume reduction
use of wearable tech to increase physical activity in inpatient rehabilitation for patients with chronic pain

Conditions: Chronic Pain; Musculoskeletal Pain

Summary: the aim of this project is to evaluate whether use of wearable tech increases levels of physical activity in patients participating in inpatient rehabilitation for chronic pain.

chronic pain is a vast problem with profound consequences for individuals and societies. exercise and physical activity is an important part of the treatment for chronic pain. use of wearable tech might be a way to help facilitate physical activity in patients with chronic pain. here it will be evaluated whether use of wearable tech giving feedback about the user's activity level increases physical activity in patients participating in inpatient rehabilitation for chronic pain. the control group will be wearing the same wearable tech as the intervention group, but they will not receive any feedback about their activity level. the feedback application will give participants in the intervention group information about the number of pai they earn each week. pai is short for personal activity intelligence. you earn pai points every time your heart rate increases: the higher heart rate, the faster you earn pai. previous research have shown that those who achieve 100 pai or more every week over time live for an average of more than eight years longer than others. during the study all participants will take part in a traditional inpatient rehabilitation program. the program consist of two periods at the rehabilitation center with two weeks at home in-between. the study will take place during the two periods at the senter and the period at home. time spent on physical activity and number of earned pai's will be counted during the period at home.

Eligibility criteria:
inclusion criteria: * taking part in inpatient rehabilitation at unicare helefort rehabilitation center for chronic pain. exclusion criteria: * not having a smartphone (will not be able to access the mobile application). * using a wheelchair (the technology will be not able to measure activity correctly)

Keywords: exercise biomedical technology