Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of novel treatment options for adults with covid-19 pneumonia

Conditions: COVID; Corona Virus Infection; Viral Pneumonia

Summary: ccap is an investigator-initiated multicentre, randomized, double blinded, placebo-controlled trial, which aims to assess the safety and efficacy of treatment with convalescent plasma for patients with moderate-severe covid-19. participants will be randomized 2:1 to two parallel treatment arms: convalescent plasma, and intravenous placebo. primary outcome is a composite endpoint of all-cause mortality or need of invasive mechanical ventilation up to 28 days.

the study is a randomized, double blinded, placebo-controlled, multicenter study with two parallel treatment arms consisting of either convalescent plasma or intravenous placebo. we plan to enroll a total of 1100 patients yielding a statistical power of 80 % to show a 30% relative reduction in risk of mechanical ventilation or death at day 28. patients with confirmed covid-19 infection and signs compatible with pneumonia will be enrolled in the study. the participants will be randomized 2:1 to the parallel treatment arms, and receive either single dose infusion treatment. the primary outcome is a composite endpoint of all-cause mortality or need of invasive mechanical ventilation up to 28 days. interim analysis will be performed frequently. as new knowledge of treatment options for covid-19 have emerged, the treatment arms including sarilumab, baricitininb, hydroxychloroquine and oral placebo have been terminated.

Eligibility criteria:
inclusion criteria: * ≥18 years of age * confirmed covid-19 infection by presence of sars-cov-2 nucleic acid by polymerase chain reaction (pcr) * evidence of pneumonia given by at least one of the following: spo2 ≤93% on ambient air or pao2/fio2 \<300 mmhg/40 kpa or radiographic findings compatible with covid-19 pneumonia * for women of childbearing potential: negative pregnancy test and willingness to use contraceptive (consistent with local regulations) during study period * signed informed consent form by any patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representatives exclusion criteria: * in the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatment * participating in other drug clinical trials (participation in covid-19 antiviral trials may be permitted if approved by sponsor)\* * pregnant or breastfeeding, positive pregnancy test in a pre-dose examination * any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
pulmonary rehabilitation in idiopathic pulmonary fibrosis

Conditions: Idiopathic Pulmonary Fibrosis

Summary: this is an interventional double-blind randomized controlled trial, to investigate the short and long-term effects of a supervised exercise training program in patients with ipf, depending on alternate patterns of oxygen supplementation during pr.

the investigators hypothesize that pr service with supplemented oxygen supply regardless of hypoxemia may have significantly better short-term effects in patients with ipf. the study will take place in corfu general hospital, by the departments of pulmonary medicine and physiotherapy and rehabilitation, respectively. study participants will be divided in two equal arms 1:1 in a double-blind manner. one of the investigators blinded to their clinical data will assign each participant to pr service either i) with constant supplementary oxygen supply fio2 50% regardless of saturation status group a) or ii) without oxygen supply unless upon resting or exercise induced hypoxemia (saturation \<88%) (group b).

Eligibility criteria:
inclusion criteria: * diagnosis of ipf based on current established criteria * no exacerbation previous 3 months * no participation in such program previous 3 months. * if on treatment with pirfenidone or nintedanib, this will be recorded and patient should be on treatment for at least 3-6 months to achieve stable state. exclusion criteria: - concomitant diagnosis of congestive heart failure and lung cancer.

Keywords: pulmonary rehabilitation
concurrent use of two continuous glucose monitoring systems in adults with type 1 diabetes mellitus (t1dm)

Conditions: Type 1 Diabetes Mellitus

Summary: the purpose of this pilot study is to evaluate performance of the seven system and the navigator system when both devices are worn concurrently by subjects with type 1 diabetes mellitus.


Eligibility criteria:
inclusion criteria: 1. age 18 years or older; 2. have been diagnosed with type 1 diabetes and are on multiple daily injections (mdi) or continuous subcutaneous insulin infusion (csii) insulin therapy; 3. willing not to inject insulin or wear an insulin pump infusion set within 3 inches from either sensor site; 4. willing to participate in an 8-hour in-clinic session on study days 5, 10, and 15 and be willing to take 4 fingersticks per hour and have 4 blood draws per hour for the 8-hour duration of each of these in-clinic sessions; 5. willing to take a minimum of 6 fingersticks per day during home use; 6. willing to refrain from the use of acetaminophen during this study and for at least 24-hours prior to enrollment; 7. willing not to schedule an magnetic resonance (mri) scan, computed tomography (ct) scan, x-ray, for the duration of the study; 8. able to speak, read, and write english. exclusion criteria: 1. have extensive skin changes/diseases that preclude wearing the sensor on normal skin (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) at the proposed wear sites; 2. subjects who have a known allergy to medical-grade adhesives; 3. are pregnant as demonstrated by a positive pregnancy test within 72 hours of insertion; 4. have a hematocrit that is less than 30%, or greater than 55%; 5. current participation in another investigational study protocol (if a subject has recently completed participation in another drug study, the subject must have completed that study at least 30 days prior to being enrolled in this study); 6. have any condition that, in the opinion of the investigator, would interfere with their participation in the trial or pose an excessive risk to study staff handling venous blood samples (e.g., known history of hepatitis b or c).

Keywords: continuous glucose monitoring
high sensitivity cardiac troponin t in patients with atrial fibrillation admitted to an emergency department (ed)

Conditions: Atrial Fibrillation

Summary: the purpose of this study was to collect data on the prevalence and clinical significance of elevated cardiac troponin in a large registry of unselected patients with atrial fibrillation presenting to an emergency department.


Eligibility criteria:
inclusion criteria: * documented atrial fibrillation in admission ekg or diagnosis of atrial fibrillation at admission. exclusion criteria: * no patients are excluded.
pharmacokinetic study of bms-914143 in participants with normal renal function and mild, moderate, severe and end-stage renal dysfunction

Conditions: Chronic Hepatitis B Virus Infection; Chronic Hepatitis C Virus Infection

Summary: the purpose of this study is to determine the effect of renal impairment on pharmacokinetics (pk) of bms-914143.

primary purpose: protocol designed to evaluate the effect of renal impairment on pharmacokinetics of bms-914143

Eligibility criteria:
inclusion criteria: * normal renal function or mild, moderate, severe or end-stage renal dysfunction exclusion criteria: * history of uncontrolled or unstable cardiovascular, respiratory, gastrointestinal, hepatic, endocrine, hematopoietic, psychiatric or neurological conditions within 6 months of lambda administration * history of chronic liver disease including cirrhosis, hepatitis b virus (hbv), hepatitis c virus (hcv), primary biliary cirrhosis, etc * history of central nervous system or neuro-psychiatric disease. subjects with severe depression and/or other uncontrolled psychiatric conditions should not be enrolled in this study * history of of suicide attempt within the 5 years preceding bms-914143 administration * inability to tolerate subcutaneous injections * donation of \>400 ml of blood within 8 weeks or plasma within 4 weeks of planned dosing
multi-national study investigating the effect and safety of rfxiii on transfusion needs in patients undergoing heart surgery

Conditions: Acquired Bleeding Disorder; Cardiac Surgery Requiring Cardiopulmonary Bypass

Summary: this trial is conducted in canada, asia, europe and usa. the aim of this clinical trial is to investigate the effect and safety of rfxiii on transfusion needs in patients undergoing heart surgery.


Eligibility criteria:
inclusion criteria: * - planned coronary artery bypass grafting (cabg) or cabg plus single heart valve replacement/repair or planned replacement/repair of a single heart valve exclusion criteria: * known intolerance to protamine * known or suspected allergy to the used antifibrinolytic agent * refusal to receive blood or blood product * planned surgery including the aortic arch and/or descending aorta * planned surgery including any implantable ventricular assist device * adult congenital heart diseases * two or more previous cardiac surgery procedures * any known autoimmune diseases: collagen vascular disease (systemic lupus erythematosus, rheumatoid arthritis, sjögrens syndrome) - endocrine: hyperthyroidism (graves disease), adrenal insufficiency, hashimoto's thyroiditis - neurologic: multiple sclerosis, myasthenia gravis - skin: pemphigous vulgaris hematologic: pernicious anaemia, autoimmune haemolytic anaemia - vasculitis - primary or secondary antiphospholipid syndrome * weight above 140 kg
postpartum sexual function in pregnant women with covid-19

Conditions: COVID-19; Dyspareunia; Postpartum Period

Summary: the aim of this study is to identify women with postpartum sexual dysfunction and dyspareunia risk in the early period and to use the treatment and care services they need effectively. our secondary aim is to reveal the difference in sexual life in the postpartum period between healthy pregnant women and pregnant women diagnosed with covid-19.


Eligibility criteria:
inclusion criteria: * pregnant patient with covid-19 exclusion criteria: * those with known sexual dysfunction disorder

Keywords: postpartum period dyspareunia covid-19
cognitive processing in patients surviving delirium. neuropsychological, eeg and structural brain correlates.

Conditions: Septic Encephalopathy; Delirium; Sepsis

Summary: the research program explores how delirium influenced brain function in patients surviving delirium and septic encephalopathy from a non neurological specialized icu cohort from 2013 to 2015 in rigshospitalet (glostrup).

the overall aim is to understand the pathophysiological mechanism in delirium and septic encephalopathy and its consequences. for this purpose we will: 1. provide extensive cognitive testing. these results provide the basis for categorization of patients surviving septic encephalopathy and delirious patients. 2. first, the investigators will examine if the differences in cognitive function is reflected in the ability of the brain to generate high-frequency electrical oscillations that accompany and underlie perception, attention, cognition, memory formation and retrieval. it will be performed by carrying out continuous eeg (ceeg) and by examination of steady-state evoked cognitive eeg responses. 3. second, the investigations will examine mri, structural and diffusion tensor imaging sequences. hippocampal, thalamic, amygdala, lentiform nucleus and cingulate cortex volumes will be determined bilaterally and will be compared between individuals with healthy brain aging and patients that survived delirium. 4. third, the investigators will assess plasma markers of free radical production.

Eligibility criteria:
inclusion criteria for the icu cohort: * age \>18 years; * length of stay \>24 hours in the icu. exclusion criteria for the icu cohort: * expected death \<24 hours; * psychiatric illness; pre-existing delirium; severe dementia; cerebrovascular event \<six months; major surgery \<two months; * non-danish or english speaking.

Keywords: sepsis encephalopathy delirium icu eeg mri cognitive tests
serious games rehabilitation programme to treat gait and balance disorders in pd patients

Conditions: Parkinson Disease

Summary: to test the effects of a serious game rehabilitation programme in 50 patients with parkinson's disease with gait and balance disorders in a randomised controlled study


Eligibility criteria:
inclusion criteria: * parkinson's disease * gait and balance disorders resistant to dopaminergic medication exclusion criteria: * dementia * contra-indication to magnetic resonance imaging

Keywords: parkinson's disease gait rehabilitation serious game
partial liver segment 2/3 transplantation study

Conditions: Colorectal Cancer

Summary: the patients will receive hepatectomy as a 2 stage procedure. in the first surgical procedure liver segments 2-3 are removed and liver donor segments 2-3 inserted. after growth of donor segments 2-3, the remaining liver segments of the recipient are removed. the patient will at this time have only donor liver tissue in place.


Eligibility criteria:
inclusion criteria: * histologically verified adenocarcinoma in colon/rectum. * liver metastases, not amenable to liver resection * no signs of extra hepatic metastatic disease or local recurrence according to pet/ct scan within 4 weeks prior to the faculty meeting at the transplant unit, except patients may have 1-3 resectable lung lesions all\<15mm. * no signs of extra hepatic metastatic disease on ct thorax/abdomen/pelvis within 4 weeks prior to the faculty meeting at the transplant unit, except patients may have 1-3 resectable lung lesions all\<15mm. * no local recurrence according to mr-pelvis scan in patients with rectal cancer within 4 weeks prior to the faculty meeting at the transplant unit * no signs of local recurrence judged by colonoscopy / ct colography within 12 months prior to the faculty meeting at the transplant unit * good performance status, ecog 0 or 1. * satisfactory blood tests: hb \>10g/dl, neutrophiles \>1.0 (after any g-csf), trc \>75, bilirubin\<2 x upper normal level, asat,alat\<5 x upper normal level, creatinine \<1.25 x upper normal level. albumin above lower normal level. * signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to gcp, and national/local regulations. * all patients should have received at least 8 weeks of chemotherapy. exclusion criteria: * weight loss \>10% the last 6 months * patient bmi \> 30 * previous diagnosed bone or cns metastatic disease. * previous diagnosed cancer mammae or malignant melanoma. * palliative resection of primary crc tumor.

Keywords: liver metastases transplantation
egfr mutation detection from advanced nsclc patient tissue and plasma in egfr-tki treatment

Conditions: Non-small Cell Lung Cancer

Summary: this study has been designed in order to detect egfr mutation abundance of tissue and concentration of plasma from advanced non-small cell lung cancer during treatment with tyrosine kinase inhibitor (tki) .through this experiment the investigators aim to evaluate the feasibility of plasma egfr detection and evaluate the correlation of egfr mutations and prognosis.


Eligibility criteria:
inclusion criteria: * age older than 18 years and under 75 years * histologically and cytologically proven non-small cell lung cancer * clinical stages ⅲ \~ ⅳ * not receive any anti-tumor treatment * eastern cooperative oncology group performance status (ecog ps) =1\~2 * estimated survival time more than 3 months * egfr-tki treatment for first-line or second-line * voluntary to participate in this clinical trial and sign the consent form exclusion criteria: * patients have received egfr-tki therapy before the study * with other malignancy history in the recent 5 years before the study * pregnancy or breast feeding phase * inadequate samples for testing * follow-up compliance is poor

Keywords: epidermal growth factor receptor(egfr) nsclc
study to assess the efficacy and safety of three dosage strengths of pulsatile gnrh delivered from a iontophoretic patch compared to oral treatment with clomiphene or placebo in infertile females

Conditions: Infertility

Summary: the primary objective of this study is to determine the safety and efficacy of pulsatile gnrh delivered from a iontophoretic patch (lutrepatch) for induction of ovulation in women with anovulatory/ oligoovulatory infertility, compared to placebo and to a reference treatment with clomiphene citrate.


Eligibility criteria:
inclusion criteria: 1. females between the ages of 18 and 38 years 2. desire to become pregnant 3. infertile due to ovulatory dysfunction as described below: * unable to conceive for at least 1 year and * anovulatory (defined as 4 or fewer menstrual cycles per year) or oligo-ovulatory (defined as menstrual cycle frequency \> 45 days) exclusion criteria: 1. requires donor oocytes or sperm 2. two or more failed (defined as no biochemical pregnancy achieved) gonadotropin fertility treatment cycles - if previous gonadotropin success, no more than two failed subsequent cycles 3. use of insulin-sensitizing drugs (e.g., metformin) within 1 month prior to progesterone challenge

Keywords: anovulatory/oligoovulatory infertility
visual outcomes and contrast sensitivity after myopic lasik

Conditions: Myopia

Summary: evaluate visual outcomes and contrast sensitivity for subjects undergoing bilateral myopic lasik procedure using the 200 khz wavelight® fs200 femtosecond laser and the wavelight® allegretto wave® eye-q laser. the use of advanced technology may decrease the loss of contrast sensitivity and improvement of postoperative visual acuity results.


Eligibility criteria:
inclusion criteria * male or female in good general health, 18 years of age or older at the time of the pre-operative examination * patient must be able to read, comprehend and willing to give hippa and informed consent * patient is planning to undergo a bilateral lasik procedure * both eyes must have a manifest refractive error from -1.00 d to -7.00 spherical equivalent with less than or equal to 3.00d of refractive astigmatism as expressed in spectacle minus cylinder form * both eyes must have a bscva of 20/20 or better * both eyes must demonstrate refractive stability confirmed by clinical records, previous glasses, or investigator's discretion. * patient must be willing to comply with study dosing and complete the entire course of the study. exclusion criteria * a patient with evidence of keratoconus, corneal irregularity, or abnormal videokeratography in either eye * a patient seeking monovision * a patient with a known hypersensitivity to any of the components of the procedural or post-lasik medications * a patient requiring the use of any ocular drop(s) and/or medication(s) in either eye during the study period with the exception of ocular drops and/or medications provided by the investigator * a patient having any surgical procedure within a week preceding the scheduled lasik surgery * a patient with any uncontrolled systemic disease (i.e., a potential patient in whom therapy for a systemic disease is not yet stabilized ) * a patient with a history of prior intraocular or corneal surgery (including cataract extraction), active clinically significant ophthalmic disease or abnormality (including, but not limited to, blepharitis, recurrent corneal erosion, dry eye syndrome, neovascularization \> 1mm from limbus), clinically significant lens opacity, clinical evidence of trauma (including scarring) inside the visual axis, or evidence of glaucoma or propensity for narrow angle glaucoma in either eye * a patient with a significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, may increase the risk associated with study participation or may interfere with the interpretation of study results * a patient with a history of any of the following medical conditions, or any other condition that could affect wound healing: uncontrolled diabetes, collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or simplex, endocrine disorders (including, but not limited to unstable thyroid disorders and diabetes), lupus, and rheumatoid arthritis * current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.

Keywords: lasik
observational study on the use of novoseven® for haemostatic treatment of bleeding episodes in patients with acquired haemophilia

Conditions: Acquired Bleeding Disorder; Acquired Haemophilia

Summary: this study is conducted in europe. the aim of this prospective, observational study are to describe the different clinical practice and detailed haemostatic management of activated recombinant human factor vii (novoseven®) in patients with acquired haemophilia in france. the secondary aim is to assess the primary haemostasis disorder associated with the coagulation disorders, if available.


Eligibility criteria:
inclusion criteria: * diagnosed with acquired haemophilia * treated with activated recombinant human factor vii as first line treatment * treated with activated recombinant human factor vii after january 2011 exclusion criteria: * patients with first diagnosis before january 2010 and having a relapse after january 2011 * known hypersensitivity to novoseven®, or to mouse, hamster or bovine protein
external lid loading for the temporary treatment of the paresis of the m. orbicularis oculi: a clinical note

Conditions: Incomplete Closure of Lid; Parotis Tumor; m. Orbicularis Oculi Paresis

Summary: the note re-introduces the external lid loading with the help of a lead weight for the temporary treatment of lagophthalmos. although simple and effective, the technique is rarely used.instead of wearing a monoculus, the patient uses an individually tailored lead weight (0.8 mm thickness, 1.0 -2.0 g) sticked on the lid, it enables its closure. a spontaneous ptosis indicates a too heavy weight. with the m. levator palpebrae intact, lid lifting is possible. the effect is gravity dependent, so that the patient has to wear the monoculus at night. to minimize the risk of lead intoxication, the surface of the weight is varnished. in case of a persistent paresis of the m. orbicularis oculi an internal lid loading can follow. a total of 152 lagophthalmos cases have been treated since 1997.all patients could close the lid immediately. almost half of the patients had to re-adjust the weight several times per day due to hooded eyelids. the compliance was high, and a partial or complete restoration of the function of the m. orbicularis oculi occurred in 60% of the cases. in some subjects, the restoration of the m. orbicularis oculi was faster than of the m. orbicularis orbis. the external lid loading for the temporary treatment of lagophthalmos is simple and effective. compared to a monoculus, the vision is unimpaired and the aesthetic is more appropriate for most patients. the faster restoration of the m. orbicularis oculi hints at a potentially facilitatory effect of the weight.


Eligibility criteria:
inclusion criteria: * lagophthalmos due to surgery, central or peripheral paresis able to understand the purpose of the study exclusion criteria: * skin irritations and/or open wounds in the area of the applied lead weight

Keywords: lagophthalmos parotis tumor m. orbicularis oculi paresis