Kornimate/medical-research-clean huggingface dataset:
u011 - wireless ultra long-term eeg recordings in epilepsy

Conditions: Epilepsy

Summary: the present study is a 13 months pre-market open-label, prospective study for confirmation of continuous performance and safety of uneeg episight solution in subjects with uncontrolled epilepsy (indicated for eeg monitoring with the implant) in which seizures are detectable in an area of the implant. the surgical procedure, device satisfaction, and effectiveness of the uneeg episight solution will also be evaluated during the clinical investigation.

the study is a multi-center study with 2-5 european sites in 2-4 countries. each site will enrol up to 10 subjects, but total enrolment will not exceed 22 to reach 19 completers of 40 days of recording. the total recruitment period is expected to be 6 months and the total study duration is expected to be approximate 22 months (first subject first visit to last subject out).

Eligibility criteria:
inclusion criteria: * patients with uncontrolled epilepsy in which seizures are detectable in an area covered by the implant * adults (above 18 years) * is willing and able to use the uneeg episight solution day and night for the duration of the study * subject is willing and able to provide written informed consent * subject is able to complete all study-required procedures, assessments and follow-up exclusion criteria: * vulnerable subjects, including severe cognitive impairment precluding informed consent * cannot or do not have the necessary assistance, to properly operate the system * high risk of surgical complications, such as active systemic infection and haemorrhagic disease * involved in therapies with medical devices that deliver electrical energy into the area around the implant, such as cochlear implant(s), implantable brain stimulation and external/transcranial brain stimulation * contraindications to the local anaesthetic used during implantation and explantation
treatment of episodic migraine with auricular neuromodulation: a prospective randomized, placebo-controlled study

Conditions: Migraine Disorders

Summary: migraine is a ubiquitous pathology affecting approximately 1 billion individuals and being the leading cause of morbidity worldwide before the age of 50. migraine treatment consists of two main approaches: acute treatment to relieve headache symptoms and preventive treatment to reduce the frequency of migraine attacks by at least 50%. preventive treatment involves medications such as beta-blockers, antiepileptics, calcium channel blockers, and a new therapeutic class called calcitonin gene-related peptide (cgrp) inhibitors. while traditional treatments have modest efficacy and limited tolerability, cgrp inhibitors have shown better tolerability and superior efficacy. however, their prescription in france is restricted to neurologists and specialized pain evaluation and treatment units. additionally, the long-term effects of cgrp inhibition on blood pressure control and vascular homeostasis are not fully understood. in addition to pharmacological preventive treatment, non-pharmacological approaches have emerged, such as auricular neurostimulation. this can be achieved through electrical stimulation of the cymba conchae, considered a non-invasive alternative to invasive vagal stimulation, and has shown benefits in reducing the number of migraine days compared to a placebo. another approach involves stimulation of specific areas of the entire auricle using techniques borrowed from auriculotherapy (auricular acupuncture). the objective of the study is to demonstrate that auricular neuromodulation, performed with a laser device, targeted and personalized on selected areas of the auricle, has a beneficial effect on the number of moderate to severe migraine days per month.


Eligibility criteria:
inclusion criteria: * 18 years ≥ aged ≤ 60 years * moderate to severe migraine for at least one year * migraines appeared before the age of 50 and diagnosed according to ihs (international headache society) criteria. * therapeutic failure of at least 2 migraine preventive medications * frequency of migraine days ≥ 4 per month and \< 15 per month exclusion criteria: * pathology of the auricle (e.g. epithelioma) * patient treated with botulinum toxin for migraine ≤ 2 months * patient treated with anti-cgrp for migraine, with last injection less than 3 months ago * patient treated with non-invasive auricular stimulation ( tens)
a study of 1592u89 in hiv-infected patients

Conditions: HIV Infections

Summary: the purpose of this study is to see if it is safe to give 1592u89 to hiv-infected patients. this study also examines the effect 1592u89 has on plasma viral load (the level of hiv in the blood).

cohorts of 8 patients are entered sequentially into 1 of 6 1592u89 dosing regimens. all patients receive 12 weeks of monotherapy during the initial 12-week treatment phase. on completion of the treatment phase, patients are offered continuation therapy with 1592u89 for a minimum of 12 weeks.

Eligibility criteria:
inclusion criteria concurrent medication: allowed: prophylaxis for opportunistic infections. patients must have: * hiv-1 infection. * cd4 cell count 100 - 500 cells/mm3 within 3 to 5 weeks prior to study drug administration. * no active diagnosis of aids (other than non-visceral kaposi's sarcoma) according to the 1993 cdc aids surveillance definition. exclusion criteria co-existing condition: patients with the following conditions and symptoms are excluded: * malabsorption syndrome or other gastrointestinal dysfunction that may interfere with drug absorption. * chronic disease such as diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction that in the opinion of the investigator, would compromise the safety of the patient. concurrent medication: excluded: * immunomodulating agents. * chemotherapeutic agents. * antiretroviral therapy. note: * patients who elect to continue study treatment into the extended phase may, after consultation with their primary physician, combine 1592u89 at a recommended dose of 300 mg bid with other licensed antiretroviral drugs. concurrent treatment: excluded: radiation therapy. patients with the following prior conditions are excluded: * history of clinically relevant hepatitis or pancreatitis within 6 months prior to study drug administration. * history of hypersensitivity, anaphylactic, or idiosyncratic reaction to nucleoside analogs. prior medication: excluded: * treatment with immunomodulating or cytotoxic chemotherapeutic agents within six weeks prior to study drug administration. * antiretroviral therapy within 2 weeks prior to administration of study drugs. prior treatment: excluded: radiation therapy within six weeks prior to study drug administration. current alcohol or illicit controlled substance use that in the opinion of the investigator, may interfere with the patient's ability to complete the study.

Keywords: hiv-1 reverse transcriptase inhibitors anti-hiv agents
effectiveness of assertive continuing care for youth

Conditions: Substance Use Disorders

Summary: following discharge from residential treatment 324 adolescents are randomly assigned to assertive continuing care with and without motivational incentives in a 2 x 2 factorial design. clinical outcomes are assessed at 3, 6, 9, and 12 months post discharge.


Eligibility criteria:
inclusion criteria: * met dsm-iv diagnostic criteria for abuse or dependence on alcohol or another drug in the past year * been between the ages of 12 and 18 at the time of residential admission; and (c) resided in one of ten illinois counties targeted for the intervention exclusion criteria: * left residential treatment prior to the seventh day * did not return to a target county at discharge * showed evidence of cognitive impairment that interfered with understanding of study instruments, procedures, or the informed consent process * were deemed dangerous to themselves or others during treatment * were a ward of child protective services and inaccessible for the intervention * met dsm-iv criteria for pathological gambling * were discharged to the state department of corrections * were already participating in a treatment study
pilot study of [68ga]ga-aby-025 imaging in patients undergoing treatment with her2-targeted therapy

Conditions: Locally Advanced Cancer; Metastatic Cancer

Summary: the purpose of this study is to determine if the radiotracer, \[68ga\]ga-aby-025, used for pet imaging can help us better identify and visualize lesions or tumors, in patients who are receiving standard of care therapy her2+ cancers.

this study will assess a dose of aby-025 followed by a tracer dose of \[68ga\]ga-aby-025 in subjects with her2+ solid cancers, or her2+ or low breast cancer undergoing or planning to undergo treatment with standard-of-care her2-targeted therapy for an fda-approved indication. the study drug will be administered on day 0, and \[68ga\]ga-aby-025 pet/ct scan will be obtained the same day after injection of study drug. patients will receive a phone call from a study coordinator post-injection to assess for adverse events. subjects will undergo standard of care evaluation of their advanced disease per the discretion of their treating physician.

Eligibility criteria:
inclusion criteria: 1. age \>/= 18 years. 2. patients with unresectable locally advanced or metastatic cancer who are eligible for standard of care treatment with her2-targeted therapy per the discretion of their treating physician for an fda-approved indication. patients may be actively undergoing or planning to start her2-targeted therapy at the time of study enrollment. 3. must have a previous biopsy demonstrating her2 expression in at least one lesion (her2+ patients or breast cancer patients who are her2+ or her2-low) as defined by ihc and fish studies or with her2 amplification as defined by a liquid biopsy that was done as standard of care testing for the patient's cancer type. 4. measurable disease on ct, fdg-pet, or mri imaging for recist evaluation; patient must have measurable disease outside the liver. 5. life expectancy of at least 6 months. patients with brain metastases are permitted to enroll on this study. exclusion criteria: 1. measurable sites of disease only in the liver. 2. inability to comply with study procedures. 3. hypersensitivity or allergy to any component of \[68ga\]ga-aby-025. 4. pregnant or breastfeeding. 5. her2-negative cancers that have no fda approved indication for treatment with her2-directed therapy. 6. inability to lie flat for 30 minutes during an imaging session. 7. medical or psychiatric co-morbidities that, in the opinion of the treating physician, would prevent the patient from successfully participating in the study.

Keywords: her2 cancer advanced cancer metastatic ihc fish trastuzumab t-dm1 pertuzumab margetuximab neratinib lapatinib tucatinib everolimus
capillary and venous blood count parameters

Conditions: Hematological Diseases; Healthy Volunteers

Summary: the purpose of this study is to compare capillary blood count parameters with the corresponding venous samples to verify the hypothesis that capillary and venous blood count parameters are equivalent.

in patients with haematological diseases regular blood count analyses are necessary. in haematology, capillary blood count analyses became established in routine diagnostics. the method and procedure of capillary blood sampling is well accepted by both the patients and the medical personal for a long time. however, only venous values are generally accepted in clinical routine. it is important to know whether or how capillary blood gives discrepant results for the various parameters. values for therapeutic decisions, e.g. transfusion, are only known for venous values. so far, there are only deficient data available. therefore, the aim of this study is (i) to compare capillary blood count parameters with the corresponding venous samples to verify the hypothesis that capillary and venous blood count parameters are equivalent, (ii) to include an adequate large number of adult haematological patients (with low and high values) and healthy adults, (iii) to obtain difference values for conversation of measured capillary values into the corresponding venous values.

Eligibility criteria:
inclusion criteria: * patients with haematological diseases ≥18 years * healthy volunteers ≥18 years * informed consent * no participation in another study 3 month before and during the study exclusion criteria: * subjects \<18 years * healthy subjects with acute or chronic infections and autoimmune or malignant diseases

Keywords: blood count capillary venous adult reference values
efficacy study of glyc-101 to evaluate outcomes after laser ablation

Conditions: Wounds

Summary: the primary objectives of this study are to evaluate safety and efficacy of topically applied glucoprime gel (glyc-101, 0.1% and glyc-101, 1.0%) in promoting wound healing in cosmetic surgery patients undergoing carbon dioxide laser skin resurfacing (co2 lsr) of the lower eyelids. the study will observe the effects of the topical agent over the course of 1 month following the initial treatment.


Eligibility criteria:
inclusion criteria: * male and female healthy volunteer subjects, between 25 and 70 years of age, giving informed consent for facial laser ablation of the lower eyelid areas for the purpose of wrinkle removal. * lower eyelid skin is free of any irritation, scarring or dermatologic conditions which might interfere with the study. * willing and able to participate in the study and follow all study directions. * able to read, understand and sign the consent form prior to any study related procedures. exclusion criteria: * female subjects who are pregnant, nursing, or planning a pregnancy during the course of the study, as determined by the interview and a urine pregnancy test. * presence of irritation or dermatologic skin conditions in the lower eyelid area. * known allergies to materials within the test formulations (i.e., yeast and/or yeast products). * use of topical or systemic drugs (corticosteroids, retinoids, immune modulators, immune suppressants, drugs with potential for contact dermatitis, drugs with potential for skin discoloration) that may have an effect on wound healing or may impact skin pigmentation. * a history, upon wounding, of developing thickened scars, keloids, or excessive pigment change. * an unstable or severe inter-current medical condition that, in the opinion of the investigator, might interfere with interpretation of study results or render the subject at high risk for treatment complications. * use of any investigational medication or device for any indication within 30 days of screening.

Keywords: burn wounds wound healing
study to evaluate the safety and tolerability of cc-94676 in participants with metastatic castration-resistant prostate cancer

Conditions: Prostatic Neoplasms

Summary: the purpose of this study is to assess the safety, tolerability and preliminary efficacy of cc-94676 in men with progressive metastatic castration resistant prostate cancer.


Eligibility criteria:
inclusion criteria: * must have histologically or cytologically confirmed adenocarcinoma of the prostate * progressed on androgen deprivation therapy (adt) and at least one prior secondary hormonal therapy approved for castration-resistant prostate cancer (crpc) * eastern cooperative oncology group (ecog) performance status (ps) 0 or 1 exclusion criteria: * prior treatment with an androgen receptor (ar) degrader * concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 1 year prior to the first dose of ip * clinically significant venous thromboembolism within 3 months prior to the first dose of ip * any significant medical condition, such as uncontrolled infection, laboratory abnormality, or psychiatric illness other protocol-defined inclusion/exclusion criteria apply

Keywords: prostate cancer cc-94676 castration-resistant prostate cancer adenocarcinoma of the prostate prostatic neoplasms castration-resistant neoplasms
pembrolizumab + epacadostat vs pembrolizumab + placebo in recurrent or progressive metastatic urothelial carcinoma

Conditions: UC (Urothelial Cancer)

Summary: the purpose of this study was to evaluate the efficacy and safety of pembrolizumab + epacadostat vs pembrolizumab + placebo as a treatment for recurrent or progressive metastatic urothelial carcinoma in patients who have failed a first-line platinum-containing chemotherapy regimen for advanced/metastatic disease.


Eligibility criteria:
inclusion criteria: * histologically-confirmed diagnosis of urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra, that is transitional cell, or mixed transitional/non-transitional (predominantly transitional) cell type. * progression or recurrence of urothelial carcinoma following one prior platinum containing chemotherapy regimen for metastatic or unresectable locally advanced disease. a participant who receives a neoadjuvant or adjuvant platinum-containing regimen following cystectomy for localized muscle-invasive urothelial carcinoma is acceptable (without further systemic treatment), if recurrence/progression occurs ≤ 12 months following completion of therapy. * measurable disease based on recist v1.1. * have provided an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for pd-l1 analysis. * eastern cooperative oncology group (ecog) performance status of 0 or 1. * adequate organ function per protocol-defined criteria. exclusion criteria: * urothelial carcinoma that is suitable for local therapy with curative intent. * history or presence of an abnormal electrocardiogram (ecg) that, in the investigator's opinion, is clinically meaningful. * known additional malignancy that is progressing or has required active treatment within the past 3 years. * known active central nervous system (cns) metastases and/or carcinomatous meningitis. participants with previously treated brain metastases may participate provided they are radiologically stable, ie, without evidence of progression for at least 4 weeks by repeat imaging. * active autoimmune disease that has required systemic treatment in past 2 years. * known history of human immunodeficiency virus (hiv) infection. hiv testing is not required unless mandated by local health authority. * known history of or is positive for active hepatitis b (hbsag reactive) or has active hepatitis c (hcv rna). note: testing must be performed to determine eligibility. * use of protocol-defined prior/concomitant therapy.

Keywords: urothelial carcinoma programmed cell death protein 1 (pd-1) inhibitor indoleamine 2,3-dioxygenase (ido) inhibitor
cerclage for twins with short cervical length ≤ 15mm

Conditions: Twin Pregnancy With Antenatal Problem; Preterm Birth; Short Cervix

Summary: this is a multicenter randomized study designed to determine if ultrasound indicated cerclage reduces the incidence of spontaneous preterm birth \<34 weeks in asymptomatic women with twin gestations and cervical length ≤15mm, diagnosed by transvaginal ultrasound between 16 to 23 6/7 weeks of gestation.

twin pregnancies have 59% incidence of preterm delivery (before 37 weeks of gestation), with increased perinatal mortality and neonatal morbidity. no therapy has proven effective in preventing preterm birth in twins. the transvaginal cervical length (tvcl) performed before 24 weeks have been determined to be the best tool to identified women with twin pregnancy at risk of preterm birth (ptb). when short tvcl is identified before 24 weeks, the risk of preterm birth is 60%-70% for tvcl ≤25mm and 80%-90% for tvcl ≤15mm. there are a small number of case reports of cervical cerclage in twin pregnancies with cervical length ≤15mm that suggest decreased preterm birth by 80%. the investigators' objective is to determine if ultrasound indicated cerclage in reduces the incidence of spontaneous preterm birth \<34 weeks and improve perinatal outcome in asymptomatic women with twin gestations and cervical length ≤15mm between 16 to 23 6/7 weeks of gestation.

Eligibility criteria:
inclusion criteria: 1. pregnant women more than 18 years of age (limits the participants to female gender) 2. diamniotic twin pregnancy 3. asymptomatic 4. transvaginal cervical length ≤ 15 mm between 16-23 6/7 weeks gestation exclusion criteria: 1. singleton or higher order than twins multiple gestation 2. transvaginal cervical length \>15mm 3. cervical dilation with visible amniotic membranes 4. amniotic membranes prolapsed into the vagina 5. fetal reduction after 14 weeks form higher order 6. monoamniotic twins 7. twin-twin transfusion syndrome 8. ruptured membranes 9. major fetal structural anomaly 10. fetal chromosomal abnormality 11. cerclage already in place for other indication 12. active vaginal bleeding 13. clinical chorioamnionitis 14. placenta previa 15. painful regular uterine contractions 16. labor
haemodynamic changes during anaesthesia in the prone position, evaluated using transoesophageal ultrasound

Conditions: Obesity; Spinal Surgery; Anaesthesia; Changes in Left and Right Ventricle Dimension; Changes in Bloodflow Across Cardiac Valves; Changes in Dimensions of Inferior Caval Dimension and Hepatic Venous Bloodflow; Changes i Myocardial Velocities; Changes in Diastolic Function

Summary: transoesophageal ultrasound examination before and after prone position.

patients undergoing spinal surgery in the prone position are anaesthetized and then an ultrasound probe is placed in the oesophagus and the heart physiology is examined. following prone position the examination is repeated.

Eligibility criteria:
inclusion criteria: * adult patients scheduled for spinal surgery in the prone position. body mass index above 30. exclusion criteria: * significant cardiomyopathy or valvular disease * heart rhythm other than normal sinus rhythm * coagulopathy * increased risk of oesophageal injury during probe insertion
the hydration to optimize metabolism (h2o metabolism) pilot study

Conditions: Low Water Intake; High Vasopressin

Summary: this study evaluates increased hydration (1.5 l of water daily during 6 weeks) on top of habitual water intake in the lowering of the vasopressin marker copeptin and in the lowering of plasma glucose concentration in adults with signs of low water intake at recruitment (elevated levels of copeptin, high urine osmolality, low urine volume).

high plasma concentration of vasopressin (i.e. antidiuretic hormone) is a novel and independent risk factor for type 2 diabetes, the metabolic syndrome, cardiovascular disease and premature death. the main physiological role of vasopressin is to maintain constant plasma osmolality. previous studies in rats and a mendelian randomization study in humans suggest causality between elevated vasopressin concentration and elevated plasma glucose concentration. as vasopressin can be suppressed by increasing water intake, the investigators hypothesize that water supplementation in individuals with high vasopressin can lower plasma glucose and prevent diabetes. the aim of this pilot study is to test if six weeks of water supplementation of 1.5 liters of extra water per day in low-drinkers with high copeptin can significantly alter hydration markers in general and reduce plasma copeptin in particular. furthermore, the investigators also aim at investigating whether this 6-week water intervention can significantly reduce fasting plasma glucose concentration.

Eligibility criteria:
inclusion criteria: * provision of informed consent * age 20-75 years * high plasma concentration of copeptin of \>6.1 pmol/l in women and \> 10.7 pmol/l in men * 24-hour urine osmolality \> 600 milliosmol (mosm) /kg water. exclusion criteria: * 24-hour urine volume \>1.5 l * pregnancy or breastfeeding * plasma sodium \<135 mmol/l * use of diuretics, lithium or ssri drugs * chronic kidney disease (estimated glomerular filtration rate \< 30ml/min) * heart failure * inflammatory bowel disease * type 1 diabetes or type 2 diabetes treated with insulin * vulnerable subjects (subjects with legal guardian, with loss of personal liberty)

Keywords: hydration water vasopressin copeptin glucose