Kornimate/medical-research-clean huggingface dataset:
post market clinical follow-up (pmcf)study of the contour neurovascular systemtm

Conditions: Intracranial Aneurysm

Summary: cerus endovascular is sponsoring a prospective, multi-center pmcf to document the safety and performance of the contour neurovascular system™ (hereinafter "contour") in normal medical use.

the primary objective of this study is to document the safety and performance of the "contour neurovascular system™. the data from the study will be reported as a post market study to the notified body as part of the post market surveillance (pms) and post market clinical follow-up (pmcf) plan.

Eligibility criteria:
inclusion criteria: * 1. patient indicated for treatment of a single, unruptured aneurysm is according to the national/international guidelines. 2. age 18 years or older at screening. 3. patient suitable for non-emergency endovascular embolization of saccular ias. 4. ia located at a bifurcation in the anterior or posterior circulation with dimensions consistent with implant size selection guidelines included in the ifu for contour. 5. patient has the necessary mental capacity to participate and is willing and able to participate in the study for the duration of the study follow-up and is able to comply with study requirements. 6. patient is able to give their informed consent. this must be demonstrated by means of a personally signed and dated informed consent document indicating that the subject has been informed of and understood all pertinent aspects of the study. * exclusion criteria 1. ruptured aneurysm. 2. patient anatomy or physiology considered unsuitable for endovascular treatment. 3. contraindication for arterial access. 4. largest measured ia equatorial diameter \>8.5 mm or \<2 mm. 5. largest measured ia neck diameter \>8 mm or \<2 mm. 6. target ia contains other devices/implants that could interfere with proper placement of the contour device (e.g., coils). 7. known allergy to platinum, nickel or titanium. 8. known allergy or intolerance to contrast agents. 9. contraindication to anticoagulants or platelet inhibitor medication. 10. in the opinion of the investigator, any other medical issue within the brain that precludes the device implantation such as brain surgery, radiation in the target area of intervention, acute traumatic craniocerebral injury, etc. 11. other medical conditions that cause an inability to comply with study requirements and/or that could increase the risk of neurovascular procedures or death within 2 years (e.g., liver failure, cancer, heart failure, chronic obstructive pulmonary disease, immunosuppression, neural disease, substance abuse and hematologic disorders etc.). 12. participating in another study with investigational devices or drugs that would confound the effects of the study outcomes. 13. the presence of a condition that may create unacceptable risk during the aneurysm embolization procedure. 14. female patient who is pregnant or breastfeeding.
rct: added value of coordinator for the management of hip fracture patients

Conditions: Osteoporosis

Summary: introduction: hip fracture due to osteoporosis is associated with an extremely high mortality morbidity and loss of quality of life. the risk of future fracture after a first hip fracture is increased. several studies reported that patients who suffered from a fracture are not optimally treated and do not receive osteoporosis treatment after the first fracture episode. aim: to evaluate whether a coordinator increases the optimal management of osteoporotic fracture patients and hip fracture patients.

material and methods: population: identification in the "iris public hospital network of all patients above 50 years" who suffer from hip fracture. exclusion of those due to high energy fractures and due to known cancer. first observational phase of treatment followed by randomized controlled trials of 2 years. intervention (rct): added value of a coordinator. measured outcomes : a. new fractures. b. a score of optimal management of osteoporosis. definition of the score and management: 1. realization of a bone density measurement. 2. identification of secondary osteoporosis. 3. identification of risk factors and calculation of the probability of a future fracture using frax score. 4. attempt to correct risk factors of osteoporosis when possible. 5. prevention of falls. 6. prescription of calcium and vitamin d. 7. prescription of a medical osteoporosis treatment. 8. report to the general practitioner.

Eligibility criteria:
inclusion criteria: * identification in the "iris public hospital network of all patients above 50 years" who suffer from hip fracture. exclusion criteria: * exclusion of those due to high energy fractures and due to known cancer.

Keywords: osteoporosis, hip fracture, fractures, bone density
interleukin-2, vinblastine, and gm-csf in treating patients with metastatic kidney cancer

Conditions: Kidney Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. interleukin-2 may stimulate a person's white blood cells to kill cancer cells. combining chemotherapy with interleukin-2 and gm-csf may be a more effective treatment for kidney cancer. purpose: phase ii trial to study the effectiveness of low-dose interleukin-2, vinblastine, and gm-csf in treating patients with metastatic kidney cancer.

objectives: i. determine the effect of sargramostim (granulocyte-macrophage colony-stimulating factor; gm-csf) in combination with interleukin-2 and vinblastine on the response rate of patients with metastatic renal cell carcinoma. ii. assess the potential toxicities of this treatment combination in these patients. outline: this is a single arm, nonrandomized study. patients receive vinblastine as an iv bolus once every 2 weeks. interleukin-2 is administered by subcutaneous injection on days 1-5 each week for 9 weeks. sargramostim (granulocyte-macrophage colony-stimulating factor; gm-csf) is administered by subcutaneous injection on days 1-5 each week for 9 weeks. each 9 week cycle is followed by 3 weeks of rest. patient may continue treatment for a maximum of 5 cycles in the absence of disease progression. patients are assessed every 12 weeks for the duration of treatment. projected accrual: 20-35 patients will be accrued into this study.

Eligibility criteria:
disease characteristics: histologically proven inoperable, metastatic, or recurrent renal cell carcinoma measurable or evaluable disease no brain metastases patient characteristics: age: over 18 performance status: swog 0-2 life expectancy: at least 3 months hematopoietic: neutrophil count greater than 1,500/mm3 platelet count greater than 100,000/mm3 hepatic: liver enzymes less than 3 (5 if known liver metastases) times institutional normal renal: creatinine less than 1.5 mg/dl cardiovascular: adequate cardiac function no unstable angina no significant coronary artery disease no heart failure with new york heart association classification iii or iv pulmonary: no evidence of pulmonary disease (documented normal dlco and pft) other: no prior malignancy except: nonmelanoma skin cancer carcinoma in situ of any kind no pregnant or lactating fertile patients must use adequate contraception normal thyroid functions as evidenced by normal t4 and tsh prior concurrent therapy: biologic therapy: no more than 1 prior biologic therapy at least 4 weeks since prior biologic therapy chemotherapy: no more than 1 prior chemotherapy at least 4 weeks since prior chemotherapy endocrine therapy: no more than 1 prior hormonal therapy at least 4 weeks since prior hormonal therapy radiotherapy: at least 4 weeks since prior radiation therapy no prior radiation therapy if entire tumor was within radiation field surgery: not specified

Keywords: stage iv renal cell cancer recurrent renal cell cancer
an escalating dose indomethacin for the treatment of persistent patent ductus arteriosus (pda) in preterm infants

Conditions: Patent Ductus Arteriosus

Summary: a large patent ductus arteriosus (pda) is associated with congestive heart failure, pulmonary hemorrhage, chronic lung disease (cld), necrotizing enterocolitis (nec) and intraventricular bleeding. indomethacin is the first line of treatment for pda. failure of ductal closure with the first course of indomethacin is reported in 30-40% of infants, with a higher failure rate in infants weighing \< 1000 gm. pda ligation is associated with early postoperative hypotension, oxygenation failure and adverse neurodevelopmental outcome in preterm infants. the use of escalating doses of indomethacin in the treatment of persistent pda was found to be safe and decreased the need for pda ligation without adverse effects in one observational study.we hypothesize that the use of an escalated dose of intravenous indomethacin will result in an increase in the probability of survival without need for surgical ligation of pda as compared to a standard dose indomethacin in newborn infants \< 29 weeks of gestational age with persistent pda.

this study is a randomized control trial.those eligible infants will be randomized to either a standard dose group or to escalating dose indomethacin group after obtaining parental consent. the infants randomized to the standard dose group will receive indomethacin (0.1 mg/kg) at 24 hr intervals for 5 days. escalating dose group infants will receive indomethacin (0.2 mg/kg/dose) at 12 hr intervals for 2 doses, followed by indomethacin (0.3 mg/kg/dose) at 12 hr interval for 2 doses, then indomethacin (0.4 mg/kg/dose) at 12 hr interval for 2 doses, increased to indomethacin (0.5 mg/kg/dose) at 12 hour interval for 2 doses and finally indomethacin 0.6 mg/kg/dose at 12 hourly interval for 2 doses. to keep the study blinded, the standard group will receive 5 extra doses of normal saline infusion of similar volume at 12 hrly intervals between the indomethacin schedules to match the escalating dose indomethacin schedule. daily echo will be performed and if the echo showed closure of pda after 3 days of assigned treatment, no further indomethacin will be given in both the groups.

Eligibility criteria:
inclusion criteria: * preterm infants with gestational age \< 29 weeks and/or birth weight \< 1251gm * presence of pda after completion of first course of indomethacin exclusion criteria: * infants with pda dependent congenital heart disease * chromosomal or major congenital anomalies * infants in whom use of indomethacin is contraindicated.(i.e.infants with acute renal failure,necrotizing enterocolitis,severe thrombocytopenia (platelet count \< 60,000/ mm3) and evidence of clinical bleeding (pulmonary bleeding, severe intraventricular bleeding grade 3\&4)

Keywords: patent ductus arteriosus
comparison of 0.4% hyaluronic acid solution versus hydroxyethylamide solution in submucosal endoscopic resections

Conditions: Esophageal Neoplasms; Endoscopic Mucosal Resection; Hyaluronic Acid

Summary: this is a randomized, single-center clinical trial that will compare the efficacy of two substances used in the submucosal cushion formation stage of endoscopic submucosal resections of early esophageal malignant neoplasms. such substances are hyaluronic acid in the form of ts-905 blue eyeₒ and hydroxyethylamide (voluven®).

1. design of the study: this is a randomized clinical trial in a single center. the lesions will be randomized into three blocks based on the diameter of the largest axis (less than 3 cm, between 3 - 5 cm and greater than 5 cm). 2. selection of patients: the population studied will be patients with early esophageal neoplasia diagnosed and/or referred for submucosal endoscopic dissection at the são paulo cancer institute (icesp), university of são paulo. 3. evaluation of effectiveness and definitions: effectiveness will be measured from the degree of usefulness. the degree of utility will be determined from two variables: obtaining or not a complete block resection and additional number of submucosal injections performed during endoscopic dissection. the solution that results in a complete block resection with a number of additional injections of 0 (excellent utility degree) or 1 (good utility degree) will be considered effective.

Eligibility criteria:
inclusion criteria: * patients over 18 years of age * superficial esophageal adenocarcinoma or squamous cell carcinoma with indication of esd after discussion in a multidisciplinary oncological board * signed informed consent form exclusion criteria: * residual or recurrent esophageal lesions * ulcerated esophageal lesions * patients with severe cardiovascular, kidney or liver disease * history of hypersensitivity to hyaluronic acid * pregnant or lactating women

Keywords: esophageal neoplasms endoscopic mucosal resection hyaluronic acid
a study to evaluate sage-217 in participants with essential tremor

Conditions: Essential Tremor

Summary: this study is a three-part, multicenter, phase 2a study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of sage-217 in adult participants with essential tremor.

part a of the study was an open-label design with morning dosing of sage-217 for 7 days and included 16 participants, 8 of whom qualified for, and entered, part b. part b had a double-blind, placebo-controlled, randomized withdrawal design with morning dosing for 7 days. part c was an open-label design with morning and evening dosing for 14 days and included a different set of 18 participants. parts a and b were stopped early (in advance of the planned sample size). this study was previously posted by sage therapeutics. in november 2023, sponsorship of the trial was transferred to biogen.

Eligibility criteria:
key inclusion criteria: * participant must have a diagnosis of essential tremor (et), defined as bilateral postural tremor and kinetic tremor, involving hands and forearms, that is visible and persistent and the duration is \>5 years prior to screening. key exclusion criteria: * participant has presence of abnormal neurological signs other than tremor or froment's sign. * participant has presence of known causes of enhanced physiological tremor. * participant has concurrent or recent exposure (14 days prior to admission visit) to tremorogenic drugs. * participant has had direct or indirect trauma to the nervous system within 3 months before the onset of tremor. * participant has historical or clinical evidence of tremor with psychogenic origin. * participant has convincing evidence of sudden tremor onset or evidence of stepwise deterioration of tremor.

Keywords: tremor
dex on microcirculation in ss-a double-blinded study

Conditions: Septic Shock

Summary: the investigators preliminary study showed that dexmedetomidine might improve microcirculation in septic shock patients. to test this effect, the investigators will conduct double-blinded study.

dexmedetomidine is a highly selective α2-adrenoreceptor agonist for sedation of adult critically ill patients which exhibits sedative and analgesic effects. recent studies suggest that dexmedetomidine to restore adrenergic vasoconstrictor responsiveness in septic shock, and prevents alterations of pain rat model intestinal microcirculation induced by surgical stress，even it can reduce the mortality of endotoxemic rats and patients with severe sepsis. the investigators preliminary study showed that dexmedetomidine might improve microcirculation in septic shock patients. to test this effect, the investigators will conduct double-blinded study.

Eligibility criteria:
inclusion criteria: * septic shock patients despite early goal directed therapy * agree to participate this study exclusion criteria: * age\< 18 * pregnancy * bradycardia (hr\<55bpm) * systolic blood pressure \< 80 mmhg / mean arterial pressure \< 50 mmhg on maximal support * death imminent * unlikely to survive 90 days * acute liver failure * dementia * high-grade block in the absence of a functioning pacemaker.

Keywords: dexmedetomidine microcirculation septic shock
midi (mr imaging abnormality deep learning identification)

Conditions: Neurological Disorder

Summary: the study involves the development and testing of an artificial intelligence (ai) tool that can identify abnormalities using patient head scans conducted for routine clinical care and research volunteer scans. a deep learning algorithm will be developed using a dataset of retrospective and prospective mri head scans to train, validate, and test convolutional networks using software developed at the department of biomedical engineering, king's college london. the reference standard will be consultant radiologist reports of the mri head scans.

an automated strategy for identifying abnormalities in head scans could address the unmet clinical need for faster abnormality identification times, potentially allowing for early intervention to improve short- and long-term clinical outcomes. radiologist shortages and increased demand for mri scans lead to delays in reporting, particularly in the outpatient setting. furthermore, there is a wide variation in the management of incidental findings (ifs) discovered in 'healthy volunteers.' the routine reporting of 'healthy volunteer' scans by a radiologist poses logistical and financial challenges. it would be valuable to devise automated strategies to reliably and accurately identify ifs, potentially reducing the number of scans requiring routine radiological review by up to 90%, thus increasing the feasibility of implementing a routine reporting strategy. deep learning is a novel technique in computer science that automatically learns hierarchies of relevant features directly from the raw inputs (such as mri or ct) using multi-layered neural networks. a deep learning algorithm will be trained on a large database of head mri scans to recognize scans with abnormalities. this algorithm will be trained to classify a subset of these scans as normal or abnormal and then tested on an independent subset to determine its validity. if the tested neural network demonstrates high diagnostic accuracy, future research participants and patients may benefit, as not all institutions currently review their research scans for incidental findings and clinical scans may not be reported for weeks in some cases. in both research and clinical scenarios, an algorithm could rapidly identify abnormal pathology and prioritize scans for reporting. in summary, the aim is to develop a deep learning abnormality detection algorithm for use in both research and clinical settings.

Eligibility criteria:
inclusion criteria: * all head mri scans with compatible sequences * \> 18 years old exclusion criteria: * no corresponding radiologist report * no consent for future use of the research images held within the historic database stored at the centre for neuroimaging sciences (kings college london). * poor image quality
us-guided percutaneous electrolysis (epe®) in shoulder pain

Conditions: Shoulder Pain

Summary: scientific evidence of conservative management of subacromial pain syndrome is conflicting. there is evidence that eccentric exercise programs are effective at medium term for this pain condition. the inclusion of other therapeutic modalities is still controversial. a recent study suggests that the inclusion of us-guided percutaneous electrolysis combined with eccentric exercises can be effective at short-term for this condition. the objective of this randomized clinical trial is to determine the effectiveness at short- and long-term of the inclusion of us-guided percutaneous electrolysis (epe®) into a eccentric exercise protocol for the management of patients with subacromial pain syndrome for pain, function, disability and pressure pain sensitivity.


Eligibility criteria:
inclusion criteria: * unilateral shoulder complaints with duration of at least 3 months; * an intensity of at least 4 on an 11-point numerical pain rating scale (nprs) during arm elevation; * a positive painful arc test during abduction * at least one positive of the following tests: hawkins-kennedy test, neer's sig, empty can test, drop arm or lift-off test exclusion criteria: * bilateral shoulder symptoms * younger than 18 or older than 65 years * history of shoulder fractures or dislocation * cervical radiculopathy * previous interventions with steroid injections * fibromyalgia syndrome * previous history of shoulder or neck surgery * any type of intervention for the neck-shoulder area during the previous year

Keywords: subacromial pain syndrome eccentric exercise pressure pain us-guided percutaneous electrolysis
good intentions study

Conditions: Obesity; Overweight

Summary: the purpose of this study is to explore the effects of an intervention designed to help increase physical activity and decrease screen time.

the purpose of this study is to investigate attendance, exercise, and screen time habits in fitness center members. because they are the population under investigation, recruitment will take place via the fitness center facilities. this population is under investigation because much of this population is sedentary and does not exercise at recommended levels, despite access to physical fitness facilities. this research will investigate methods to encourage physical activity in this population.

Eligibility criteria:
inclusion criteria: * body mass index from 18-45 kg/m2 exclusion criteria: * have any medical conditions that prevent participant from safely taking part in physical activity * currently a smoker * are pregnant, breastfeeding, or plan to become pregnant * have visited fitness centers more than eight times in the past two months * exercise outside of fitness centers more than once a week for one hour at a time in the past month * do not engage in more than 14 hours a week of screen-based activities * do not have a primarily sedentary job

Keywords: exercise
study of the safety and tolerability of iv infused pg545 in patients with advanced solid tumours

Conditions: Advanced Solid Tumours

Summary: this phase ia study aims to establish the maximum tolerated dose of once-weekly iv infused pg545 and to evaluate its safety in subjects with advanced solid tumours. in addition, the study will explore whether pg545 exposure results in changes to chemicals produced by the body that are associated with cancer growth and spread.


Eligibility criteria:
inclusion criteria: * age \>=18 years. * histological or cytological documentation of non hematologic, malignant solid tumour. * have failed at least one previous therapeutic regimen. * life expectancy \>= 12 weeks. * ecog performance status 0 or 1. * written, signed and dated informed consent. * able and willing to meet all protocol-required treatments, investigations and visits. * have adequate organ function. exclusion criteria: * clinically significant non-malignant disease. * active cns metastases. * subjects with uncontrolled diabetes. * history of clinically significant adverse drug reaction to heparin or other anti-coagulant agents * concomitant use of aspirin (\> 150 mg/day), nsaids (except cox-2 selective inhibitors), vitamin k antagonists (other than low-dose), heparin within two weeks prior to randomisation, or other anti-platelet drugs. * history of severe allergic, anaphylactic or other significant adverse reaction to radiographic contrast media. * known seropositivity to the human immunodeficiency vies (hiv) * women who are pregnant or breast feeding * women of child-bearing potential and male subjects who are partners of women of child bearing potential who are unable or unwilling to use effective means of contraception. * subjects who have received an investigational agent within 28 days prior to cycle 1 day 1.

Keywords: pg545 phase i progen antimetastatic antiangiogenic advanced cancer patients solid tumors solid tumours tumor microenvironment