Kornimate/medical-research-clean huggingface dataset:
irreversible electroporation(ire) for unresectable esophageal neoplasms

Conditions: Esophageal Neoplasms

Summary: the purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (ire) for unresectable esophageal neoplasms.

by enrolling patients with unresectable esophageal neoplasms adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous ire for unresectable esophageal neoplasms.

Eligibility criteria:
inclusion criteria: * esophageal neoplasms diagnosed by positive biopsy or non-invasive criteria, * not suitable for surgical resection, * eastern cooperative oncology group (ecog) score of 0-1, * a prothrombin time ratio \> 50%, * platelet count \> 80x10\^9/l, * ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post nanoknife procedure, * able to comprehend and willing to sign the written informed consent form (icf), * have a life expectancy of at least 3 months. exclusion criteria: * cardiac insufficiency, ongoing coronary artery disease or arrhythmia, * any active implanted device (eg pacemaker), * women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception, * have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the nanoknife™ ledc system, * are in the opinion of the investigator unable to comply with the visit schedule and protocol evaluations.

Keywords: irreversible electroporation unresectable esophageal neoplasms
investigation of different scanning protocols for 3 dimensional high-resolution imaging of the human cornea with optical coherence tomography (oct) - a pilot study

Conditions: Corneal Neovascularisation; Keratoconus

Summary: the aim of the present study is to develop a protocol for optimal corneal 3-dimensional imaging based on measurements in healthy volunteers. for this purpose, a customized ultra-high resolution spectral domain oct will be used. to validate whether the protocol can also be applied in patients with corneal pathologies, for whom it is intended to be used, measurements in these patients will be performed. we propose to obtain images from patients with keratoconus, since this is one of the most frequent causes for corneal transplantations in europe and from patients with corneal neovascularization which is a major cause of vision loss in several ophthalmic diseases. based on the obtained measurement protocol, further studies investigating the pathophysiology or treatment success of several corneal pathologies can be planned.


Eligibility criteria:
inclusion criteria: healthy volunteers: * men and women aged over 18 years * normal findings in the slit lamp examination, no corneal pathologies patients with keratoconus: * men and women aged over 18 years * presence of keratoconus * no ophthalmic surgery in the 3 months preceding the study patients with corneal neovascularization: * men and women aged over 18 years * presence of corneal neovascularization * no ophthalmic surgery in the 3 months preceding the study exclusion criteria: * participation in a clinical trial in the previous 3 weeks * presence of any abnormalities preventing reliable measurements as judged by the investigator * pregnancy, planned pregnancy or lactating

Keywords: optical coherence tomography cornea imaging
cognitive behavioural group therapy versus individual supportive therapy for the prevention of repeat suicide attempts

Conditions: Suicidal Ideation; Suicide, Attempt

Summary: the primary objective of this study is to evaluate the efficacy of a program of 6 sessions of cognitive behavioural group therapy (cbgt) (as compared to 6 sessions of individual supportive therapy (ist)) designed for preventing repeat suicide attempts at 12 months post-psychotherapy in adults admitted to inpatient care for suicide attempts.

the secondary objectives of this study are to assess the efficacy of cbgt on: a. parameters describing the incidence of suicide and repeat suicide attempts, as well as suicide re-attempt free follow-up time, b. long-term changes in suicidal ideation, c. long-term changes in psychiatric symptoms (depression, hope for the future, hospitalization).

Eligibility criteria:
inclusion criteria: * the patient has been correctly informed * the patient must have given his/her informed and signed consent * the patient must be insured or beneficiary of a health insurance plan * french speaking adults (18 years or older) freely hospitalized (in centres or via emergency services) for prevention of suicide and who have a medium or high suicide risk score according to a mini international neuropsychiatric interview structured interview * presence of suicidal ideation according to the beck suicide ideation scale (score \> 3) * prior (or recent) suicide attempt within the last three month * the patient is able to understand the study and capable of giving his/her informed consent * the patient is available during the weekly time slots proposed by the investigator exclusion criteria: * the patient is participating in another study that may interfere with the results or conclusions of this study * within the past three months, the patient has participated in another study that may interfere with the results or conclusions of this study * the patient is in an exclusion period determined by a previous study * the patient is under judicial protection, or is an adult under guardianship * the patient refuses to sign the consent, or it is impossible to correctly inform the patient * emergency situations preventing proper study conduct * history of schizophrenia or other psychotic troubles * presence of psychotic symptoms at initial interview * serious cognitive impairment * medical incapacity to participate
the involvement of atp sensitive potassium channel in migraine aura and migraine pain.

Conditions: Headache; Migraine With Aura; Migraine Without Aura

Summary: the aim of the present study to investigate whether * opening of katp channels causes migraine pain by activation of meningeal nociceptors and ascending trigeminal nociceptive pathways. * opening of katp channels causes migraine aura by induction of csd.

migraine pain the trigeminovascular system is the anatomical and physiological substrate of migraine pain. nociceptive transmission originates from activation and sensitization of first-order trigeminovascular neurons. their cell bodies are in the trigeminal ganglion, and their afferent fibers innervate the meninges and its vessels. ascending nociceptive transmission from the trigeminal ganglion is projected to the brain stem, activating and sensitizing second-order trigeminovascular neurons, including those in the spinal trigeminal nucleus. this, in turn, activates and sensitizes third-order trigeminovascular neurons in the thalamus, which subsequently relay the nociceptive transmission to the somatosensory cortex and other cortical areas, ultimately resulting in migraine pain. although the biological underpinnings of migraine pain are incompletely understood, signaling pathways have been identified that are putatively responsible for the genesis of migraine pain. recent human experimental data have implicated opening of katp channels in migraine pathogenesis. in two randomized controlled trials, it was demonstrated that intravenous infusion of levcromakalim - an opener of katp channels - induced migraine pain in people with migraine with and without aura. - it remains unknown whether katp channel opening causes migraine pain by activation of meningeal nociceptors and ascending trigeminal nociceptive pathways, as proposed during spontaneous migraine attacks. migraine aura about one-third of people with migraine experience aura symptoms, which are characterized by reversible focal neurologic symptoms, typically comprising visual or hemisensory disturbances. the physiological substrate of the aura phase of migraine is thought to be cortical spreading depression (csd), a self-propagating wave of depolarization across the cerebral cortex that disrupts ionic gradients and is followed by cerebral hypoperfusion. recently, it was reported that intravenous infusion of levcromakalim - an opener of katp channels - induced migraine aura in migraine with aura patients. - it remains unknown whether katp channel opening causes csd which leads to migraine aura, as observed during spontaneous migraine attacks.

Eligibility criteria:
inclusion criteria: * migraine patients * 18-60 years. * 50-100 kg. * women of childbearing potential must use adequate contraception. exclusion criteria: * a history of serious somatic disease * any other type of headache (except episodic tension-type headache less than once a month) daily intake of any medication except contraceptives contraindications for mri scan.
effect and predictors for hot flush in women undergoing static stretching exercise

Conditions: Hot Flashes

Summary: this study investigates the effect and predictors of static stretching exercise on hot flush in women after performing 4-week stretching exercises.

hot flush (hf) is the most common symptom among menopausal syndrome and can significantly affect women's quality of life. considering the risk of hormone therapy, the behavioral therapies have been proposed for the alternative treatment of hf. however, the exercise prescription for women with hf is controversial. previous studies show the inconsistent effect of aerobic exercise on hf, and a moderate-to-high intensity exercise seems to aggravate hf frequency and severity. recent studies have shown that static stretching exercise could improve hf in middle-aged women, but the related research is quite few, and the physiological mechanism as well as predictors for responders who can benefit from stretching exercise are still not clear. the knowledge of predictors for responders will provide clinicians and clients with hf symptoms to choose static stretching exercise as their treatment.

Eligibility criteria:
inclusion criteria: 1. age between 20-65 years old. 2. with hot flashes. 3. no current therapies such as hormone therapy, psychotropic medications, or sleeping pills for the past 6 months. 4. with ability to follow instructions of stretching exercise. exclusion criteria: 1. sbp \>160 mmhg or dbp \>100 mmhg 2. medical condition under investigation or unstable condition that could affect hot flashes, like thyroid disease. 3. any medical condition limiting the ability to participate the exercise.
evaluation of a high calorie, high protein tube feeding product in an adult population with or at risk of malnutrition

Conditions: Malnutrition

Summary: this prospective, observational study is designed to observe the use of a high calorie, high protein tube feed product in adults that are malnourished or at risk of malnutrition, as assessed by a clinician, and have been placed on a nutritional care plan which includes a tube feeding formula, per standard of care.


Eligibility criteria:
inclusion criteria: * malnourished or at risk for malnutrition based on the malnutrition universal tool (must) score ≥ 2. * under the care of a health care professional for malnutrition or at risk of malnutrition and has been prescribed the study formula. * requires and agrees to be tube fed the enteral feeding product for at least 16 consecutive days as their sole-source of nutritional intake. * free living in the community or is residing in a nursing home. * conforms to the requirements set forth on the study product label. exclusion criteria: * currently taking or has taken antibiotics within 2 weeks prior to enrollment. * consuming food po. * current active cancer and the study physician determines that the subject is not suitable for the study. * history of diabetes mellitus as evidenced by taking anti-hyperglycemic medications or by self-reported dietary modification for control of diabetes mellitus. * renal or liver failure. * pregnant as demonstrated by self-report. * severe auto immune disease (per physician's discretion) and is on immuno-modulating therapy. * history of allergy to any of the ingredients in the study product. * active human immunodeficiency virus (hiv). * known dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder, or any other psychological condition that may interfere with study product consumption and does not have a caregiver who can assist them with adherence to the study protocol. * condition that is contraindicated to tube feeding the study product. * taking part in a non-approved clinical trial.
prediction of chronic kidney disease following pre-eclampsia: diagnosis and early care

Conditions: Preeclampsia

Summary: pre-eclampsia (pe) is a pregnancy-associated syndrome of variable severity, classically defined by the combination of hypertension and proteinuria in a previously non-hypertensive or proteinuric patient. these symptoms normally resolve within 2-3 months after delivery regardless of the severity of the pre-eclampsia. regardless of its definition, preeclampsia is associated with an increased risk of obstetric events and, for the mother, an increased risk of developing chronic kidney disease (ckd), hypertension, diabetes and cardiovascular disease in the broad sense. the relationship between preeclampsia and chronic kidney disease is, however, complex and not fully understood. investigator proposes an interventional study to identify the diagnosis of chronic kidney disease in patients who have developed an episode of preeclampsia.


Eligibility criteria:
inclusion criteria: * meeting the preeclampsia criteria or one of its complications (eclampsia, hellp syndrome) according to the isshp 2018 definitions within the last 5 years * having signed the informed consent * person affiliated to social security exclusion criteria: * patient with mental disability or language barrier preventing understanding of the study or consent * person deprived of liberty by judicial or administrative decision * person under forced psychiatric care * person subject to a legal protection measure

Keywords: chronic kidney disease (ckd) preeclampsia
melafind evaluations for patients with multiple nevi

Conditions: Clinically Atypical Pigmented Skin Lesion

Summary: we have added objectives 4-6 to our updated study: study objective 1: to determine whether the distribution of melafind scores is different for different patients with multiple nevi, and whether such distributions can be utilized to identify "signature" lesions for a given patient. study objective 2: to investigate whether distributions of quantitative abcd parameters differ among patients and whether these qabcd parameters identify "signature" lesions. study objective 3: to determine the feasibility of defining and using relative thresholds to improve the specificity of melafind without sacrificing its high sensitivity. study objective 4: to determine the repeatability of melafind scores for a given lesion for different patient and lesion characteristics. study objective 5: to identify patient and lesion characteristics that result in the highest variability of melafind scores for a given lesion. study objective 6: to use standard errors of melafind scores to propose a robust individual threshold for lesions to be considered for biopsy to rule out melanoma on patients with multiple nevi.


Eligibility criteria:
cutaneous lesions examined with melafind must satisfy all of the following inclusion criteria: inclusion criteria: * the lesion is pigmented (i.e., melanin, keratin, blood) * the diameter of the pigmented area is not \ 22 mm * the lesion is accessible to the melafind * the patient, or a legally authorized representative, has consented to participate in the study and has signed the informed consent form; cutaneous lesions that meet any of the following exclusion criteria will not be accepted: exclusion criteria: * the patient has a known allergy to isopropyl alcohol * the lesion has been previously biopsied, excised, or traumatized * the skin is not intact (e.g., open sores, ulcers, bleeding) * the lesion is within 1 cm of the eye * the lesion is on mucosal surfaces (e.g., lips, genitals) * the lesion is on palmar hands * the lesion is on plantar feet * the lesion is on or under nails * the lesion is located on or in an area of visible scarring * the lesion contains foreign matter (e.g., tattoo, splinter, marker)
study of ao-176 as monotherapy and in combination with bortezomib/dexamethasone in relapsed/refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: open-label, dose escalation study to evaluate the safety, tolerability, pharmacokinetics (pk)/pharmacodynamics and initial efficacy of ao-176 as monotherapy and in combination with dexamethasone and bortezomib in adults with relapsed/refractory multiple myeloma (mm).

an open-label, multicenter, dose escalation study to evaluate the safety, tolerability and pk/pharmacodynamics of ao-176 in adults with relapsed/refractory multiple myeloma whose disease has progressed following at least 3 prior systemic lines of treatment and must have progressed on the final line of therapy received before being considered for this study. the study will be conducted in 2 phases; phase 1 is an ascending-dose study of ao-176 monotherapy utilizing the classic 3+3 design, with enrollment of 3 patients per cohort and expansion of the cohort in the event of a dose-limiting toxicity (dlt). following the dose escalation portion and determination of the monotherapy recommended phase 2 dose (rp2d), an ascending dose escalation study of ao-176 and dexamethasone combined with bortezomib will be evaluated utilizing the same 3+3 dose escalation design. phase 2 will evaluate the clinical activity of ao-176 plus dexamethasone and bortezomib at the rp2d as determined in phase 1 part 2.

Eligibility criteria:
key inclusion criteria: 1. confirmed diagnosis of symptomatic mm per imwg criteria 2. measurable disease 3. relapsed or refractory to at least 3 prior systemic lines of therapy for mm 4. eastern cooperative oncology group (ecog) status 0-2 5. resolution of prior therapy-related adverse events 6. minimum of 2 weeks since last dose of cancer therapy or radiotherapy key exclusion criteria: 1. previous grade 3-4 infusion or hypersensitivity reaction 2. severe asthma or chronic obstructive pulmonary disease exacerbations requiring hospital admission or steroids 3. prior treatment with a checkpoint inhibitor (anti-pd-1, pd-l1 or ctla-4) within 4 weeks. 4. prior treatment with a therapeutic agent that targets the cd47 axis.

Keywords: ao-176 cd47 immunotherapy monoclonal antibody
a study of avastin (bevacizumab) in combination with xeloda (capecitabine) and docetaxel in patients with inflammatory or locally advanced breast cancer.

Conditions: Breast Cancer

Summary: this single arm study will assess the efficacy and safety of combination first-line treatment with docetaxel + xeloda + avastin in patients with inflammatory or locally advanced breast cancer. patients will receive 3-weekly cycles of avastin (15mg/kg i.v. on day 1 of each cycle), docetaxel (75mg/m2 i.v. on day 1 of each cycle, after avastin) and xeloda (2000mg/m2 p.o. on days 1-15 of each cycle). four cycles of chemotherapy are planned, plus an optional additional two cycles; after chemotherapy patients will be assessed for surgery. the anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.


Eligibility criteria:
inclusion criteria: * female patients, \>=18 years of age; * her2-negative, locally advanced (stage ii or iii) or inflammatory cancer of the breast; * ecog performance status 0-1. exclusion criteria: * metastatic disease (stage iv); * previous treatment for breast cancer; * evidence of cns metastasis; * current or recent (within 10 days of first dose of avastin) use of aspirin (\>325mg/day) nsaids or full dose anticoagulants for therapeutic purposes; * clinically significant cardiovascular disease.
shared care rehabilitation after acute coronary syndrome

Conditions: Acute Coronary Syndrome; Myocardial Ischemia; Acute Myocardial Infarction: Rehabilitation Phase

Summary: cardiac rehabilitation is an individual adapted multidisciplinary intervention for people suffering from heart disease. it involves; * dietary counseling, * exercise training, * psychosocial support, * physician * smoking cessation * patient education the purpose is quick and complete recovery and to reduce the chance of recurrence. in denmark people admitted with acute cardiac disease is referred to a course of hospital based cardiac rehabilitation at discharge. the danish municipal reform of 2007 changed the responsibility of rehabilitation from the regions, who runs the hospitals, to the municipalities. shared care is in this setting that elements of treatment are completed different places in health care. the aim of this study is: * to establish a shared care model for cardiac rehabilitation following admission with acute coronary syndrome and * to compare this model to the existing hospital based cardiac rehabilitation after admission with acute coronary syndrome. primary outcome is participation in cardiac rehabilitation.


Eligibility criteria:
inclusion criteria: * admission with acute coronary syndrome * resident in district of department of cardiology, aarhus university hospital, silkeborg or viborg hospital, part of the "hospitalsenheden midt" viborg, silkeborg, skive, hammel. * accept both models of cardiac rehabilitation * written informed consent exclusion criteria: * resident outside the district of department of cardiology, aarhus university hospital, viborg hospital or silkeborg hospital, part of "hospitalsenheden midt" (viborg, silkeborg, skive, hammel). * age 80 years or older * heart failure (ejection fraction less than 40%) * severe comorbidity * resuscitated and need of support from ergotherapist after discharge.

Keywords: acute coronary syndrome myocardial ischemia shared care rehabilitation community cardiac rehabilitation hospital