Kornimate/medical-research-clean huggingface dataset:
[18f] psma-1007 pet/ct in metastatic clear cell renal cell carcinoma

Conditions: Metastatic Clear Cell Renal Cell Carcinoma

Summary: staging of kidney cancer is primarily achieved by computerized tomography (ct) scans or magnetic resonance imaging (mri). if a patient is found to have limited metastatic disease, surgical removal or radiation therapy could be considered in order to control the majority of the disease. however, if metastases are more widespread, systemic (drug) therapy may be the preferred management option. the identification of additional metastatic sites using more sensitive imaging modalities therefore has the potential to alter management, and this remains an unmet need in the field. this study will investigate the utility of positron emission tomography (pet) imaging with psma (prostate specific membrane antigen). kidney cancer of the clear cell subtype has demonstrated high expression of psma, making it a disease in which psma-targeted pet imaging could help to identify occult metastatic disease.

this will be a single-institution prospective, open-label feasibility study involving patients ≥18 years of age with metastatic clear cell rcc who have not yet received systemic therapy. patients with evidence of metastatic disease on conventional imaging will require histologic confirmation by biopsy. at our institution, approximately 26 new metastatic clear cell rcc (mrcc) patients are seen each year, and a previous analysis reported that 92% of 10,105 patients with mrcc in the international mrcc database consortium (imdc) database were found to have clear cell histology; therefore, difficulty with recruitment into this study over a period of 2 years is not anticipated.

Eligibility criteria:
inclusion criteria: 1. men and women with histologically-proven, metastatic renal cell carcinoma (rcc)(tnm stage tany, nany, m1) 2. must have baseline conventional imaging of the chest, abdomen, and pelvis with contrast-enhanced ct or mri within 5 weeks of enrolment. contrast is required unless the participant cannot for medical reasons (ie renal failure). exception: unenhanced ct of the chest is acceptable exception: unenhanced mri of abdomen and pelvis is acceptable in cases of renal failure exclusion criteria: 1. pregnant or breastfeeding 2. age less than 18 3. histology does not have any clear cell component 4. unable to lie flat for 30 minutes for the scan 5. history of prior malignancy (except non-melanoma skin cancer) 6. unable to provide informed consent 7. inadequate liver function 8. systemic or radiation-based cancer treatment is needed urgently and anticipated to begin before psma scan can take place 9. previously exposed to systemic or radiation cancer therapy (except radiation for skin cancer)

Keywords: psma pet metastatic clear cell renal cell carcinoma [18f]psma-1007 psma
3 years of anastrozole vs. no treatment as extended adjuvant therapy for postmenopausal women with breast cancer

Conditions: Breast Neoplasms

Summary: the study assesses the effect of a further 3 years adjuvant treatment with anastrozole vs. an untreated control group after initial 5 years of adjuvant hormone-therapy.


Eligibility criteria:
inclusion criteria: * no disease recurrence at time of randomization, * patients with breast cancer after surgery, * 5 years (+/- 12 months) of prior endocrine therapy exclusion criteria: * premenopausal patients, * unknown or negative receptor status, * secondary malignant tumor

Keywords: hormone receptor positive breast cancer
navigate grx study

Conditions: Coronary Artery Disease

Summary: the objective of the present study is to detail the results of robotic-assisted pci using techniq automated movements in real-world clinical practice.

this multi-center, international, randomized, open-label, post-market study will enroll subjects to detail the results of robotic-assisted pci using techniq automated movements in real-world clinical practice by randomized comparison with a cohort of subjects undergoing robotic-assisted pci with techniq automated movements disabled. a secondary objective is to describe the learning curve associated with using techniq.

Eligibility criteria:
inclusion criteria: * male or nonpregnant female aged ≥ 20 years. * patients with coronary artery disease with clinical indication for percutaneous coronary intervention (pci). * the subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent. exclusion criteria: * failure/inability/unwillingness to provide informed consent. * in the opinion of the investigator, the subject is deemed unsuitable for robotic pci due to clinical status or anatomic characteristics. * acute stemi within 72 hours pre-procedure.
hamburg edoxaban for anticoagulation in covid-19 study

Conditions: Covid19

Summary: hero-19 aims to evaluate if an intensive anticoagulation strategy using edoxaban on top of standard of care (soc) of covid-19 therapy is superior to soc (in-hospital moderate anticoagulation strategy = low-dose low-molecular weight heparin \[lmwh\], ambulatory no anticoagulation, i.e. placebo within this trial) in reduction of morbidity and mortality endpoints in patients with covid-19.

coagulopathy in the context of covid-19 is a major threat to affected patients due to deep vein thromboses and pulmonary embolisms. actual data show an unexpectedly high incidence of partially fatal complications without any prior clinical evidence in some cases. therefore, this prospective, randomized, assessor-blinded, multicenter, placebo-controlled, interventional trial will investigate whether therapeutic anticoagulation on top of soc compared to prophylactic anticoagulation as part of soc- can improve objective patient-relative endpoints, relevant for prognosis in patients with covid-19. 172 eligible patients will be randomized 1:1 to experimental or control group. patients enrolled to experimental group will receive therapeutic anticoagulation using lmwh body weight-adapted during course of hospital stay and oral anticoagulation using edoxaban according to smpc (60mg once a day) after being discharged from hospital / outpatient course. patients enrolled to control group will receive prophylactic anticoagulation using lmwh as part of soc whilst inpatient course, and placebo after discharge / outpatient course. patients will be informed of their allocation to the placebo group, as it has been shown that the effect of placebo is still detectable.

Eligibility criteria:
inclusion criteria: * diagnosis of covid-19 and hospitalization on icu, or * diagnosis of covid-19 and hospitalization on normal ward, or * diagnosis of covid-19 (within 10 days) and troponin ≥ uln and/or d-dimer ≥0.5 mg/l exclusion criteria: * age below 18 * life expectancy less than 3 months before covid-19 * resuscitation \> 30 minutes * hypersensitivity to the active substance, to edoxaban or any of its excipients * significantly increased bleeding risk * other indication for anticoagulation beyond covid-19 * gfr \< 15 ml/min * planned transfer of the patient to another clinic within the next 42 days

Keywords: coagulopathy
reliability and validity of the turkish version of general sleep disturbance scale (gsds-t) in multiple sclerosis

Conditions: Multiple Sclerosis; Sleep Disturbance

Summary: the gsds-t was developed by lee ka to assess difficulty falling asleep, waking up during sleep, sleep quality, and daytime alertnes. the turkish validity and reliability of the scale have been conducted on stroke patients but not on multiple sclerosis patients. the aim of this study is to investigate the validity and reliability of the turkish version of general sleep disturbance scale (gsds-t) in patients with multiple sclerosis

the gsds-t was developed by lee ka to assess difficulty falling asleep, waking up during sleep, sleep quality, and daytime alertnes. the turkish validity and reliability of the scale has been conducted on stroke patients but not on multiple sclerosis patients. the aim of this study is to investigate the validity and reliability of the turkish version of general sleep disturbance scale (gsds-t) in patients with multiple sclerosis. gsd has 21 questions. this study will be conducted on patients with multiple sclerosis (ms). 126 participants will be included in the study. in order to evaluate the validity of the gsds-t, the pittsburgh sleep quality index (psqi) which can evaluate sleep quality and has been validated in turkish, will be used. scales will be repeated after 15 days to assess test-retest reliability.

Eligibility criteria:
inclusion criteria: * individuals over the age of 18 who have been diagnosed with multiple sclerosis for at least two years, * those with an edss score \>2. * those without symptoms of insomnia according to the diagnostic and statistical manual of mental disorders-5 (dsm-5) diagnostic criteria * individuals whose native language is turkish and who have the ability to speak and understand. exclusion criteria: * those with severe spasticity, * those with vision and hearing problems, * those with a known mental illness (major depression, schizophrenia, psychosis, etc.), * those in an acute relapse phase, * those using dietary supplements, * those using tranquilizers or immunosuppressants.

Keywords: multiple sclerosis sleep disturbances
auricular vagus nerve stimulation (avns) in chronic spinal cord injuries (sci)

Conditions: Spinal Cord Injuries

Summary: the purpose of this research is to test if auricular vagal nerve stimulation (avns) is safe in persons with spinal cord injury (sci).


Eligibility criteria:
inclusion criteria: 1. males and females 2. chronic (equal or greater to 1 year) motor-complete and incomplete sci abbreviated injury scale (ais) of a or b at the c5-t10 levels exclusion criteria: 1. pregnant or breastfeeding 2. prisoner 3. failure to satisfy inclusion criteria 4. previous bariatric surgery 5. active implantable devices (such as pacemakers) 6. skin irritation or damage at the site (ear)
physical activity coaching in chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease; Physical Activity; Health Behavior

Summary: this study is designed to explore a new approach to help people with chronic obstructive pulmonary disease (copd) become more physically active. through weekly telephone sessions with a health coach utilizing motivational interviewing, participants will be empowered to set goals for increased physical activity (emphasis on walking). the objective of the study is to determine if telephone-based health coaching is a reasonable and effective way to increase physical activity, as measured by a gold-standard activity monitor, in people with copd.


Eligibility criteria:
inclusion criteria: * men and women age 40 years and older * current or former cigarette smoker of at least 10 pack-years * diagnosis of copd stage ii to iv copd as documented by pulmonary function testing (fev1 \<80% predicted, fev1/fvc ration \<0.71) within the past 24 months * able to ambulate independently or with a walking aid (wheeled or standard walker or cane) exclusion criteria: * unable to walk without assistance of another person * patients with a high likelihood of being lost to follow-up or contact (patients with active chemical dependency), are planning to move out of the state, are not able to be contacted by telephone * patients with an inability to provide good data or follow commands (patients who are disoriented or have a severe neurologic/psychiatric condition)

Keywords: chronic obstructive pulmonary disease motivational interviewing health coaching physical activity
phase iii comparative study(open-label) of mra for rheumatoid arthritis(ra)

Conditions: Rheumatoid Arthritis

Summary: to evaluate clinical efficacy and tolerability of mra, patients with ra are randomized to receive either mra or conventional dmards.


Eligibility criteria:
inclusion criteria * diagnosed as having ra, on the basis of the criteria stipulated by the american conference on rheumatism (acr) in 1987. * with ra that has continued for at least 6 months but less than 5 years, with the date of first appearance being taken as the date of ra diagnosis. * active ra despite at least one dmard or immunosuppressant. active disease is defined as having at least 6 tender and 6 swollen joints among 49 and 46 joints stipulated by the japanese rheumatism foundation's drug evaluation committee and esr at least 30 mm/hr and crp not less than 2.0mg/dl. exclusion criteria * shown to have class-iv steinbrocker's functional activity in an evaluation carried out within 4 weeks before administration of the study drug. * treated with drugs that delay joint destruction (infliximab, etanercept, leflunomide, etc.) within 3 months before administration of the study drug. * the oral corticosteroid dose (prednisolone equivalent of up to 10 mg/day)has not been fixed 2 weeks before administration of the study drug. * subjected to any of the following within 4 weeks before administration of the study drug: (i) change in dosage of currently administered dmards and/or immunosuppressive agents. (ii) plasma exchange method. (iii) surgical treatment (operations, etc.).
"sms - heals my health"

Conditions: to Help Improve the Quality of Life of Patients

Summary: therapeutic patient education is an approach that has shown its usefulness in rheumatology, but the duration of its impact is limited, and therapeutic revisions are regularly necessary. the practice of physical activity is one of the goals of tpe in rheumatology and new technologies, such as sms messages represent a possible complementary tool to amplify behavioral changes the study primary objective is to evaluate the impact of individualized sms compared to standard sms messages on the physical activity of patients with chronic inflammatory rheumatism or osteoporosis, included in a therapeutic education program. our hypothesis is that individualized sms has a higher efficiency compared to standard sms messages to increase the practice of physical activity in these patients.


Eligibility criteria:
inclusion criteria: * patient age from 18 to 75 years * participated in therapeutic patient education program osteoporosis disease and inflammatory rheumatism disease * having given their written consent * french speaking * possessing a telephone tool that accepts sms exclusion criteria: * patients unable to read sms for practical, linguistic or cognitive reasons * patients who can not, for medical reasons or disability, set up 30 minutes of moderate physical activity (walking or other moderate activity) per day * having already participated in a similar study in inflammatory rheumatism or osteoporosis * already having the required level of physical activity: performing more than 30 minutes of moderate physical activity (walking or other moderate activity)
gut microbiome in colorectal cancer

Conditions: Gastrointestinal Microbiome; Neoplasm, Colorectal

Summary: this is a pilot feasibility study designed to investigate the alterations in the gut microbiome that occur during the course of treatment for colorectal cancer

this is a pilot feasibility study designed to investigate the alterations in the gut microbiome that occur during the course of treatment for colorectal cancer (crc). three patient cohorts will be followed. cohort a: patients treated with oral fluoropyrimidine cap as part of standard of care (soc) chemotherapy. cohort b: patients treated with tas-102 including those receiving it in combination with y-90 radioembolization as part of a clinical trial. cohort c: patients receiving cap plus immunotherapy (pembrolizumab) and bevacizumab as part of a clinical trial. investigators will replace participants as needed to ensure a minimum of 10 evaluable participants per cohort (or minimum total of 30 evaluable patients). evaluable participants are defined as patients with two analyzable stool samples including a baseline sample and at least one on-treatment sample to be used in endpoint analysis

Eligibility criteria:
inclusion criteria: 1. the patient has histologically proven colorectal adenocarcinoma 2. the patient is starting treatment with oral fluoropyrimidine therapy: cap or tas-102 as soc or on a clinical trial. this also includes those patients receiving treatment in the adjuvant setting or post-metastasectomy with no evidence of disease on imaging. 3. combination of oral fluoropyrimidine with other cancer-directed therapies, including oxaliplatin, bevacizumab, y-90 radioembolization, or immunotherapy checkpoint inhibitors, is permitted. 4. combination of cap with concurrent radiation is permitted, including patients undergoing radiotherapy to a rectal primary or a metastatic site. 5. male or female patient aged 18 years of age or older at the time of obtaining the signed and dated informed consent (no upper age limit). 6. be able to read and speak english. 7. be willing and able to provide written informed consent for the study exclusion criteria: 1. patient has had prior chemotherapy, biologic or immunotherapy in the previous 2 weeks. 2. patient has completed a course of antibiotics longer than 2 weeks in preceding six months or a course of antibiotics of any duration in the 4 weeks prior to starting oral chemotherapy. any patient who requires treatment with antibiotics during the study may be removed at the investigator's discretion. 3. known hiv positive.

Keywords: gut microbiome colorectal cancer oral fluoropyrimidine
tranexamic acid to improve arthroscopic visualization in shoulder surgery

Conditions: Rotator Cuff Injuries; Rotator Cuff Tears; Subacromial Impingement; Subacromial Impingement Syndrome

Summary: the purpose of this study is to determine if intravenous txa is a safe alternative to epinephrine in improving arthroscopic shoulder visualization. primary objectives 1. determine that patients given intravenous tranexamic acid improves surgeon-rated visualization compared to placebo. 2. determine that intravenous tranexamic acid is a safe alternative to epinephrine mixed irrigation fluid to improve arthroscopic shoulder visualization

in the last twenty years, the use of arthroscopy to surgically manage shoulder pathologies has expanded in its indications. the interplay between increased indications, surgeon experience, and improvements in equipment have all propelled arthroscopic shoulder surgery to preferred treatment in managing instability, rotator cuff, and impingement pathology. obtaining adequate visual clarity is paramount to performing the procedures safely, efficiently, and effectively. a variety of methods have been employed to improve visualization. this includes tighter control of blood pressure, regional anesthetic, pressure controlled irrigation system, sealed cannulas, electrocautery devices, and injecting epinephrine into irrigation fluid. the use of epinephrine in irrigation fluid has been studied in literature. the results of a few randomized controlled trials demonstrate that the vasoconstrictive properties of epinephrine decrease blood flow and consequently, improves surgeon visualization. however, there has been reports of ventricular tachycardia, lethal arrhythmias, and epinephrine induced pulmonary edema in literature that suggests that the addition of epinephrine in irrigation fluid may have caused these adverse events. therefore, it is important to examine other alternatives, such as txa, that can decrease bleeding and improve visualization without potential detrimental effects. this trial will be conducted in compliance with the protocol, gcp, and the applicable regulatory requirements.

Eligibility criteria:
inclusion criteria: * able to read and understand patient consent form and give informed consent * rotator cuff pathology or impingement that have clinical indications for shoulder arthroscopy surgery (either rotator cuff repair or subacromial decompression exclusion criteria: * have an active thromboembolic event * allergies or hypersensitivies to txa or any of the ingredients * have a seizure disorder * on hormonal contraceptives * pregnant * history of venous thromboembolism in the previous 12 months, or requiring lifelong anticoagulation related to previous vte. vte is defined as a cerebrovascular event (stroke, transient ischemic attack, deep vein thrombosis, and pulmonary embolism or with a history of hypercoagulable disorders (i.e. factor v lieden, antiphospholipid antibody) * acquired disturbances of colour vision * hematuria with renal cause
compare train and 3d-4d left ventricular systolic function in subjects suffering from dystrophy and healthy subjects

Conditions: Steinert's Disease

Summary: steinert's disease is an orphan disease. the prognosis of patients with this disease is conditioned by cardiac involvement. search an early stage alterations in contractile function in subjects suffering from dystrophy would detect patients at risk of sudden death. the first stage of work is to validate the tools to detect early stage of infringement systolic function in a population of patients with myotonic dystrophy.


Eligibility criteria:
inclusion criteria: * patients suffering from muscular dystrophy type 1 followed chu poitiers. * age ≥ 18 years exclusion criteria: * duration qrs\> 120 ms ecg permanent ventricular stimulation * trouble segmental kinetic obvious to echocardiography in visual analysis
observe real-life allocation of atypical antipsychotics in the acute inpatient management of schizophrenia

Conditions: Schizophrenia

Summary: the primary objective of this non- interventional study (nis) is to describe the use of atypical antipsychotics in subjects with schizophrenia during the hospitalisation due to acute psychotic episode by evaluation of drug, dose and mode of administration of the medication.

reconnect-s beta

Eligibility criteria:
inclusion criteria: * meet the diagnostic criteria for schizophrenia stated in the diagnostic and statistical manual of mental disorders, 4th edition (dsm-iv) criteria. * subject is hospitalised due to an acute psychotic episode. * ability of the subject to understand and comply with the requirements of the study, as judged by the investigator. exclusion criteria: * current participation in any clinical trial. * previous enrolment in the present nis (in case of recurrence occurred during the enrolment period).

Keywords: acute psychotic episode of schizophrenia
effects of the use of adjuvant drugs after extracorporeal shockwave lithotripsy (eswl) in renal calculus

Conditions: Renal Calculi

Summary: the investigators objective is to study if some drugs can improve the success rate of extracorporeal shockwave lithotripsy for renal stones.

extracorporeal shockwave lithotripsy is one of the modalities of treatment of renal stones. it´s a machine that breaks the renal stones extracorporeally. some drugs, like alpha blockers and calcium channel blockers, can improve the success rates of this procedure. our objective is to study the real effects of two drugs, tamsulosin and nifedipine, compared to placebo, in the elimination of fragments after the extracorporeal shockwave lithotripsy treatment.

Eligibility criteria:
inclusion criteria: * radiopaque renal stone, 5 to 20 mm, located at renal pelvis or superior or middle calix exclusion criteria: * inferior calix, any contraindication for extracorporeal shockwave lithotripsy, pregnancy, coagulopathy, previous renal surgery, age under 18, abdominal aorta aneurism and urinary infection.

Keywords: kidney calculi lithotripsy calcium channel blockers adrenergic alpha-antagonists.