Kornimate/medical-research-clean huggingface dataset:
miniject glaucoma implant in european patients

Conditions: Glaucoma, Open-Angle; Glaucoma Eye; Intraocular Pressure

Summary: the study will evaluate the efficacy and safety of the miniject glaucoma implant and intraocular pressure (iop) lowering effects with or without glaucoma medications. the procedure will be a stand-alone surgery. overall, the patient will be asked to perform several examinations up to 24 months after surgery.

the primary endpoint is the 'qualified success' rate at 6 months after surgery greater than 60%. 'qualified success' is defined as a diurnal iop ≤ 21mmhg (millimeter mercury) and \> 5mmhg with a minimum 20% diurnal iop reduction from baseline with or without the concomitant use of allowed glaucoma hypotensive medication at 6 months after surgery

Eligibility criteria:
inclusion criteria: * males or females, 50 years of age or older. * diagnosis of primary open angle glaucoma during screening visit or earlier. * grade 3 (open, 20-35 degrees) or grade 4 (wide open, 35-45 degrees) according to shafer angle grading system. exclusion criteria: * diagnosis of glaucoma other than primary open angle glaucoma (e.g. angle closure glaucoma or secondary open angle glaucoma) in the study eye. * grade 2 (narrow, 20 degrees), grade 1 (extremely narrow, less or equal to 10 degrees) and grade 0 (closed or slit) according to shafer angle grading system. * neovascular glaucoma in the study eye. * corneal opacity or iridocorneal angle not visible through gonioscopy prisma in the study eye, preventing correct placement of the implant.

Keywords: minimally invasive glaucoma surgery glaucoma implant lower iop iop intraocular pressure
pounce™ thrombectomy system retrospective registry

Conditions: Peripheral Arterial Disease; Acute Limb Ischemia

Summary: the prowl registry is an open-label retrospective, multi-center, us study of the surmodics™ pounce™ thrombectomy system for the non-surgical removal of emboli and thrombi in the peripheral arterial vasculature.


Eligibility criteria:
inclusion criteria: * subject underwent an endovascular intervention where the pounce thrombectomy system was attempted * subject is willing and able to provide informed consent prior to the collection of study data or a consent waiver is in place exclusion criteria: * subject is under the age of 18 years
the effect of exercise on pharmacodynamics and pharmacokinetics of a single dose of unfractionated heparin

Conditions: Blood Coagulation Disorder

Summary: the aim of this project is to assess the influence of exercise on pharmacokinetics (pk) and pharmacodynamics (pd) of a single dose of subcutaneously (sc) administered unfractionated heparin (ufh). it is hypothesized that exercise will increase the systemic exposure (pk) and therefore the clinical effects (pd) of the sc administered ufh. to assess this, healthy male volunteers will be included in a controlled, randomized, crossover study, where they, on four separate days, will have ufh injected sc in the thigh, followed by different exercise interventions (one per experimental day). blood sampling, with the aim of assessing pk and pd will be performed during the following hours.


Eligibility criteria:
inclusion criteria: * body weight 50 kg or more * body mass index 18.5-25 kg/m2 * acceptance of not drinking alcohol for 24 hours before to 24 hours after dosing of study drug * acceptance of not performing physical activity for 24 hours before to 24 hours after dosing of study drug * signed informed consent form exclusion criteria: * history or sign of bleeding disorders * history or sign of kidney disease * history or sign of liver disease * average systolic blood pressure \ 140 mmhg and/or average diastolic blood pressure \ 90 mmhg (average of three measurements performed at screening). * daily pharmaceutical treatment * contraindication to increased levels of physical activity (10) * smoking or other regular use of any form of nicotine products during the study period and the previous 3 months. * current or prior participation (within 3 months before screening) in other clinical trials that might affect the results of this study (judged by the investigator). * previous treatment with heparins * low levels of anti-thrombin (p-antitrombin(enz.) \<0,80 kiu/l)
early diagnosis and stem cell transplantation for severe immunodeficiency diseases

Conditions: Severe Immunodeficiency Diseases

Summary: the hypothesis of this study is that children with severe primary immunodeficiencies will benefit from early stem cell transplantation utilizing a reduced intensity conditioning regimen. this regimen is associated with a low risk of complications and will lead to correction of the underlying immunological defects.


Eligibility criteria:
inclusion criteria: * must show one of the following diseases: * scids * hyper-igm * wiskott-aldrich syndrome * chediak-higashi and griscelli syndromes * x-linked lymphoproliferative diseases * ipex syndrome * nemo syndrome * other severe immunodeficiency diseases not stated above at the discretion of the principal investigator * informed consent * adequate renal function * adequate liver function * adequate cardiac function * adequate pulmonary function * adequate performance statue * adequate venous access exclusion criteria: * patient/family has not signed informed consent * patient does not have a clear diagnosis of a severe immunodeficiency disease * a suitable donor for the patient cannot be found * patient is hiv positive * patient has active hepatitis b * patient is pregnant * patient is considered unsuitable for transplant at the discretion of the principal investigators or the medical director

Keywords: patients with the severe immunodeficiency diseases severe immunodeficiency diseases
mobile study - a study of bonviva (ibandronate) regimens in women with post-menopausal osteoporosis

Conditions: Post Menopausal Osteoporosis

Summary: this study will compare the efficacy and safety of different treatment regimens of oral bonviva tablets in women with post-menopausal osteoporosis. patients will also receive daily supplementation with vitamin d and calcium. the anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.


Eligibility criteria:
inclusion criteria: * women 55-80 years of age; * post-menopausal for \>= 5 years; * ambulatory. exclusion criteria: * malignant disease diagnosed within the previous 10 years (except basal cell cancer that has been successfully removed); * breast cancer within the previous 20 years; * allergy to bisphosphonates; * previous treatment with an intravenous bisphosphonate at any time; * previous treatment with an oral bisphosphonate within the last 6 months, \>1 month of treatment within the last year, or \>3 months of treatment within the last 2 years.
study comparing hai plus chemotherapy and chemotherapy alone in patients with unresectable crlm

Conditions: Colorectal Adenocarcinoma Metastatic to the Liver

Summary: to date no prospective trials have been completed that demonstrated whether hai is an effective adjunct to systemic chemotherapy (target therapy) with respect to advantages in conversional resection rates and survival compared with chemotherapy (target therapy) alone. the primary objective of this trial is to determine conversional resection rates and survival for patients with colorectal cancer liver metastasis are treated with hai plus chemotherapy ± target therapy, compared to chemotherapy ± target therapy only.


Eligibility criteria:
inclusion criteria: * all patients must meet the following criteria: * patients must have histologically confirmed incurable crlm and no clinical or radiographic evidence of extrahepatic disease * patients is medically eligible to receive hai, as determined by the mdt (multidisciplinary team) * eastern cooperative oncology group (ecog) performance status 0 or 1 * age \> 18 years * subject life expectancy \> 3 months * platelets \> 100×103/mm3 * total bilirubin \<1.5mg/dl * creatinine level \< 2.0 mg/dl * all patients must sign an informed consent form exclusion criteria: * the crlm is amenable to curative surgical therapy * prior radiation, tace or hai to the liver * uncorrectable coagulopathy * subject is pregnant, nursing, or wishes to become pregnant during the study other serious medical condition (uncontrolled infection, uncontrolled cardiac disease) would preclude study treatment or impact survival * current or planned treatment with any experimental chemotherapy or target drugs

Keywords: colorectal cancer liver metastasis hepatic arterial infusion chemotherapy target therapy conversional resection rates
middle meatal bacteriology during acute respiratory infection in children

Conditions: Acute Respiratory Infection; Sinusitis

Summary: the purpose of this study is to find out whether the children with respiratory infection and the presence of pathogenic bacteria (s. pneumoniae, h. influenzae or m. catarrhalis) in the nasal middle meatus benefit from antimicrobial treatment.

acute sinusitis is one of the most common disease in children requiring antimicrobial treatment. the diagnosis and treatment outcomes of acute sinusitis are contradictory, and better diagnostic criteria are needed. in adults with acute maxillary sinusitis, bacterial culture results obtained from the nasal middle meatus are comparable to those obtained from sinus puncture and aspiration. in children, the presence of pathogenic bacteria (s. pneumoniae, h. influenzae or m. catarrhalis) in the nasal middle meatus during respiratory infection predicts longer duration of signs and symptoms of common cold. in this randomized placebo-controlled study, the effect of the antimicrobial treatment (amoxicillin-clavulanate) is examined in children with pathogenic bacteria (s. pneumoniae, h. influenzae or m. catarrhalis) in the nasal middle meatus during respiratory infection. the duration of the symptoms and speed of recovery is recognized by daily symptom-diary, the results are compared between the treatment groups.

Eligibility criteria:
inclusion criteria: * acute respiratory infection with nasal symptoms (nasal obstruction or discharge) * seeking medical help from health centre for the respiratory symptoms * pathogenic bacteria (s pneumoniae, h influenzae or m catarrhalis) identified from right or left nasal middle meatus in the endoscopically taken swab culture sampling taken by a study investigator (all microbiological analyses are done by the national public health institute´s microbiological laboratory in oulu) exclusion criteria: * otitis, tonsillitis or other disease requiring antimicrobial treatment * respiratory infection within 4 weeks of screening * antimicrobial treatment within 4 weeks of screening * allergy to penicillin or amoxicillin

Keywords: respiratory infection sinusitis rhinosinusitis children middle meatal specimens respiratory track bacteria amoxicillin-clavulanate pneumococci haemophilus moraxella
physician-assisted dying in mentally ill patients - which criteria are decisive?

Conditions: Physician-Assisted Suicide

Summary: physician-assisted dying (pad) is currently a highly controversial topic in medical ethics and public debates worldwide. it poses a moral conflict between the ethical principle of respect for patient autonomy and the ethical principle of beneficence in the sense of preserving life. switzerland gives higher weight to the former principle: article 115 of the swiss penal code (stgb) permits pad, provided it is not performed for "selfish reasons", and thus, occupies a special role in international comparison. however, the swiss federal law does not regulate who exactly is entitled to access pad, and there is no universal agreement in the concerned professional societies. additional uncertainty arises when not the wish for pad of a somatically ill person but that of a mentally ill person is to be assessed. it is therefore important for switzerland - but also internationally - to regulate pad for the mentally ill. on the one hand, mentally ill persons must not be discriminated in their desire for pad compared to somatically ill persons while at the same time, their vulnerability must be taken into account. on the other hand, treating physicians must be protected in their ethical integrity and need security when they have to decide on pad-requests. with the present study, we aim at contributing to the discussion of pad in mentally ill patients and, with the help of an online/telephone survey, provide insights of the current situation in switzerland within the general population and in the medical profession. this study addresses the following research questions: what is the attitude of the general population towards the current swiss academy of medical sciences (sams) ethical guidelines? what is the attitude of medical professionals? to what extent does the public discussion reflect the current situation in clinical practice? does the stigmatization of the mentally ill have an influence on the assessment of their wish to die, and if so, where do prejudices need to be reduced? the study thus aims to expand the scientific literature on this highly relevant, currently controversial topic.


Eligibility criteria:
inclusion criteria: * the inclusion criteria for participants from the general population are: (1) between 18 and 65 years old, and (2) sufficient knowledge of german, italian, or french. medical professionals are included if they are registered in one of the cantons basel-stadt, basel-landschaft, aargau, lucerne, graubünden, ticino or vaud. physicians from all specialties are to be surveyed to be able to draw a comparison between the different medical professionals. exclusion criteria: -
autologous bone marrow-derived stem cells transplantation for retinitis pigmentosa

Conditions: Retinitis Pigmentosa

Summary: the purpose of this study is to evaluate the short-term safety of a single intravitreal injection of autologous bone marrow stem cells in patients with retinitis pigmentosa.

a prospective phase i, nonrandomized open-label study of retinitis pigmentosa patients with best-corrected etdrs visual acuity (bcva) worse than 20/200. standardized ophthalmic evaluation will be perform at baseline and at weeks 1, 4,12 and 24 (±1) following intravitreal injection of 10 x 106 bone marrow stem cells/ 0,1ml . three measures will be used to evaluate the short-term safety of intravitreal of abmdsc: 1) severe visual loss, defined as a drop in 15 letters on etdrs visual acuity scale; 2) decrease in erg response; 3) decrease in 5 square degrees on visual field; secondary safety outcomes : 1) increase in intra-ocular inflammation defined herein as anterior chamber cells and flare higher than 3+ for more than 1 month after injection according to a classification described elsewhere ; 2) decrease in cmt more than 50um; 3)genesis of abnormal tissues (teratomas) or tumors; 4) qualitative changes in retinal or choroidal perfusion, like macular nonperfusion. secondary outcome measures will be used to evaluate the short-term efficiency of intravitreal of abmdsc: 1) improvement in erg response; 2) increase in visual field: 3) increase in csmt \> 50um and not related to macular edema; 4) increase \> 5 letters on bcva

Eligibility criteria:
inclusion criteria: * diagnosis of retinitis pigmentosa * logarithm of minimum angle of resolution (logmar) bcva of 1.0 (snellen equivalent, 20/200) or worse exclusion criteria: * previous ocular surgery other than cataract * presence of cataract or other media opacity that would influence ocular fundus documentation and adequate erg and visual field evaluation * other ophthalmic disease like glaucoma and uveitis * previous history of blood disorders like leukemia * known allergy to fluorescein or indocyanine green * known coagulation abnormalities or current use of anticoagulative medication other than aspirin.

Keywords: retinitis pigmentosa stem cell bone marrow
cabergoline as a preventive treatment for chronic migraine

Conditions: Migraine

Summary: headache disorders constitute a major global disease burden, and migraine - with a one-year prevalence of 15 % - is the sixth most disabling condition. though a common disease, the pathogenesis is still unclear. thus, the treatments have different mechanisms of action and preventive treatments are only effective in approximately 50% of chronic migraine patients. recent evidence from mice models and a study of prolactine-associated headaches have indicated that dopamine agonists such as cabergoline might be used as a treatment of migraine. the aim of this study is to test the hypothesis that the dopamine agonist cabergoline can be used as a treatment of chronic migraine. a randomized controlled trial of 24 patients with chronic migraine will be conducted, comparing cabergoline to placebo as an add-on medication to the patients' migraine treatment over a 12 weeks period. the primary outcome is change in migraine frequency, but also headache-related hospital contacts, and quality of life as well as prolactin levels and biomarkers of the pituitary-gonadal-axis. the results of the study will help understand the pathogenesis of migraine and might also introduce a more effective and affordable preventive migraine treatment.


Eligibility criteria:
inclusion criteria: * migraine and more than 6 days with headache every months exclusion criteria: * cardiac valve disease * hypertension * psychiatric disease * treated with dopamine receptor agonists, dopamin receptor antagonists, macrolides and itraconazole * pregnant or breastfeeding
effects of hypothermia upon outcomes after acute traumatic brain injury

Conditions: Traumatic Brain Injury

Summary: induction of hypothermia to \< 35˚c by \< 2.5 hours after severe traumatic brain injury, reaching 33˚c by 4 hours after injury and maintained for 48 hours in patients aged 16-45 will result in an increased number of patients with good outcomes at six months after injury compared to patients randomized to normothermia.

nabis:hiir was a randomized clinical trial conducted in patients with severe brain injury, age 16-45. patients were randomized to standard treatment at normothermia or to standard treatment with moderate hypothermia (32.5-34c for 48 hours). an intent to treat analysis was used with the primary outcome measure as the glasgow outcome scale at six months after injury. gos is dichotomized into good outcome (good recovery/moderate disability) and poor outcome (severe disability, vegetative, dead).

Eligibility criteria:
inclusion criteria: 1. non-penetrating brain injury with post-resuscitation glasgow coma score (gcs) \< 8 (motor 1-5) 2. estimated or known age \> 16 and \< 45 years old 3. time of injury within 2.5hrs of arrival at hospital exclusion criteria: 1. gcs = 7 or 8 with a normal head cat scan (ct) scan or showing only mild subarachnoid hemorrhage (sah)or skull fracture or gcs \> 9 post- randomization 2. gcs = 3 and bilaterally non-reactive pupils 3. abbreviated injury score (ais) \> 4 for any body area except head 4. positive abdominal ultrasound or ct scan 5. persistent hypotension (systolic blood pressure \< 110mmhgg) 6. persistent hypoxia (o2 saturation \< 94%) 7. positive pregnancy test 8. injured greater than 2.5 hours from hospital arrival 9. pre-existing medical conditions, if known

Keywords: traumatic brain injury hypothermia
clinical validation of an artificial intelligence algorithm to help interpret mammograms

Conditions: Breast Cancer

Summary: this aims to clinically validate, on a large population, a tumor detection aid software which has already been trained on a representative french population (from several hospital centers and liberals from several departments in the west and east of france). this population consists of 1000 patients who have been treated for breast cancer (histologically proven by breast biopsy) and whose investigators have mammograms performed at the time of diagnosis. the control population consists of the unaffected breast of each patient (with the exception of the rare cases of bilateral cancers). this innovative software has the main feature of recognizing healthy breast tissue, allowing the radiologist to focus on breast tissue at risk, improving the management of medical time and the management of "difficult" files.


Eligibility criteria:
inclusion criteria: * adult woman (40 to 75 years old) * treatment at the university hospitals of strasbourg between 2010 and 2020 for breast cancer * including mammography and histological evidence available * patient who has already given her consent for the reuse of her anonymous data for research purposes exclusion criteria: * woman who expressed her opposition to participating in the study

Keywords: breast cancer mammography artificial intelligence tumor detection on mammograms
russian registry of patients with namd

Conditions: Neovascular Age-Related Macular Degeneration

Summary: a three-year, non-randomized, observational, multicenter prospective namd study - patient registry.

the registry is a structured system which uses observational study methods for systematic collection of data on health condition in the specific patient population. real world clinical practice data will be collected. patients will not undergo any additional examinations or procedures that are outside of the standard clinical practice

Eligibility criteria:
inclusion criteria: * age \> to 18 years * male or female patients diagnosed with namd (with or without previous treatment for namd including but not limited to pdt, laser coagulation, vitamins, retinolamine, emoxipine, anti-vegf therapy or any surgery for namd). * willing and able to provide informed written consent personally or by legal proxy exclusion criteria: * the patient does not meet the inclusion criteria; * the patient is simultaneously participating in a different namd therapy study.

Keywords: neovascular age-related macular degeneration namd
study of olverembatinib (hqp1351) in patients with cp-cml

Conditions: Chronic Myeloid Leukemia; CML; CML, Chronic Phase

Summary: a global multicenter, open label, randomized, phase 3 registrational study of olverembatinib (hqp1351) in patients with chronic phase chronic myeloid leukemia (polaris-2)

the hypothesis suggests that in part a, olverembatinib leads to a higher mmr rate compared to bosutinib in cp-cml patients without the t315i mutation; and in part b, olverembatinib can provide therapeutic benefits to cp-cml patients with the t315i mutation.

Eligibility criteria:
inclusion criteria: patients eligible for inclusion in this study must meet all of the following criteria. 1. age ≥ 18 years old. 2. diagnosis of cml-cp 3. part a: previously treated with at least two approved tkis part b: t315i mutation at screening. 4. eastern cooperative oncology group (ecog) performance status (ps) ≤ 2. 5. written informed consent obtained prior to any screening procedures. 6. patients with adequate organ functions exclusion criteria: patients eligible for this study must not meet any of the following criteria. 1. for part a only: t315i mutation at any time prior to starting study treatment. 2. active infection that requires systemic drug therapy 3. impairment of gastrointestinal (gi) function or gi disease that may significantly alter absorption of study drugs 4. previous treatment with or known / suspected hypersensitivity to olverembatinib or any of its excipients. 5. previous treatment with or known / suspected hypersensitivity to bosutinib or any of its excipients. 6. pregnant or nursing (lactating) women.