Kornimate/medical-research-clean huggingface dataset:
clinical evaluation of two daily disposable lenses in a population of daily disposable (dd) lens wearers

Conditions: Myopia

Summary: the purpose of this study is to evaluate the performance of two daily disposable contact lenses in a population of daily disposable contact lens wearers.


Eligibility criteria:
inclusion criteria: * currently wearing any spherical daily disposable contact lens except the two study products for at least 3 months prior to enrollment. * currently wearing contact lenses at least 8 hours/day and 5 days/week. * other protocol inclusion/exclusion criteria may apply. exclusion criteria: * eye injury or surgery within twelve weeks immediately prior to enrollment. * currently enrolled in any clinical trial. * prior history of corneal or refractive surgery. * monovision correction. * other protocol inclusion/exclusion criteria may apply.
trial in aml secondary to mpns patients, unfit for intensive chemotherapy, investigating a treatment combination including decitabine and venetoclax

Conditions: Acute Myeloid Leukemia

Summary: prospective, multi-center, intervention, open clinical trial for the treatment of aml secondary to mpn in patients unfit for intensive chemotherapy investigating a combination regimen including ven and dec.

prospective, multi-center, intervention, open clinical trial for the treatment of aml secondary to mpn in patients unfit for intensive chemotherapy, investigating a combination regimen including ven and dec to improve the survival outcome.

Eligibility criteria:
inclusion criteria: 1. patients with aml secondary to myeloproliferative neoplasms (saml), untreated, newly diagnosed, according to who 2016 criteria based on conventional cytological, cytogenetic, and immunophenotypic disease characterization 2. patients unfit for intensive treatment modalities at the discretion of the investigator. 3. ecog performance status 0-2 or disease-related reversible ecog 3 score following adequate supportive care. 4. signed written informed consent according to ich/eu/gcp and national local laws. 5. males enrolled in the study with partners who are women of childbearing potential, must be willing to use an acceptable barrier contraceptive method during the trial exclusion criteria: 1. diagnosis of de novo aml 2. pre-existing, uncontrolled pathology such as heart failure (congestive/ischaemic, acute myocardial infarction within the post 3 months, untreatable arrhythmias, nyha classes iii and iv), sever liver disease with total bilirubin ≥2,5 x uln and/or alt\>3 uln (unless attributable to aml), acute or chronic pancreatitis, kidney function impairment with creatinine clearance (crcl) level \<30ml/min (calculated by cockcroft gault formula) (unless attributable to aml) and severe neuropsychiatric disorder that impairs the patient's ability to understand and sign the informed consent or to cope with the intended treatment plan. for altered liver, pancreas and kidney function tests, eligibility criteria can be reassessed at 24-96 hours, following adequate supportive measures. 3. pre-existing hiv positive serology (i.e. already known before enrolment). the participation to the study will require serology testing for hiv positivity at baseline: in case of hiv positivity or refusal to perform hiv testing, the patient will be considered not eligible. 4. uncontrolled bacterial or fungal infections 5. qtc \>470 msec on screening ecg (fridericia's formula) 6. a history of cancer that is not in remission phase following surgery and/or chemotherapy and/or radiotherapy with life expectancy \< 6 months.
randomized study of laser and balloon angioplasty versus balloon angioplasty to treat peripheral in-stent restenosis

Conditions: Peripheral Arterial Disease

Summary: the purpose of the study is to evaluate the safety and efficacy of laser atherectomy with balloon angioplasty compared to balloon angioplasty alone in the treatment of above the knee peripheral artery in-stent restenosis.


Eligibility criteria:
inclusion criteria: * pad with rutherford class 1-4 * resting abi \<0.9 or abnormal exercise abi \<0.9 * history of previous femoropopliteal nitinol stenting * angiographic significant restenosis (\>=50%) * target lesion length \>=4 cm; no more than 3 cm outside stent at either end * vessel diameter \>=5 mm and \<=7 mm * at least one widely patent tibial or peroneal artery to the foot exclusion criteria: * patient is pregnant or breast feeding * evidence of acute limb ischemia * life expectancy \<12 months * cva within 60 days of screening * myocardial infarction within 60 days of procedure * known allergy to contract media * known contraindication to aspirin, antiplatelet and anti-coagulation therapies * uncontrolled hypercoagulability * present or suspected systemic infection in target limb * serum creatinine \>= 2.5 mg/dl unless dialysis dependent * previous treatment to target vessel within 3 months of study procedure * drug eluting stents or covered stents in target lesion * ipsilateral and/or contralateral iliac stenosis \>= 50% ds that is not successfully treated prior to index procedure or with final residual stenosis \<= 30% documented by angiography * planned or predicted cardiovascular surgical or interventional procedures prior to completion of the 30-day follow-up * identification of any lesion below the target stent in the treated leg \>50% that will require preplanned or predicted treatment within 30 days(prior to the 6 month follow up) * tibial artery containing a \>50% diameter stenosis (ds) by visual estimate after popliteal * grade 4 or 5 stent fracture affecting target stent or proximal to the target stent, or where evidence of stent protrusion into the lumen is noted on angiography in 2 orthogonal views.

Keywords: peripheral arterial disease in stent restenosis peripheral vascular disease
study to assess the effect of ons nutridrink® 200 ml on the recovery of patients with covid-19 and respiratory support

Conditions: COVID-19

Summary: the goal of this low-interventional study was to learn about the effect a nutritional supplement in patients with covid-19 and respiratory support. the main questions it aimed to answer were: * if additional nutrition support has an effect on recovery of physical health in patients with covid-19; * to examine the effect of additional nutrition support on quality of life of patients with covid-19; * to examine the effect of the additional nutrition support on hospitalization period of patients with covid-19. participants were split into two groups. one group had the common hospital diet, another group in addition to the common diet was given with nutridrink® 200 ml x 2 daily. during the observation period participants were asked to measure hand strength measured by hand grip tester and fill out the quality of life standard questionnaire sf-36. in addition, several routine blood tests were performed.


Eligibility criteria:
inclusion criteria: * confirmed new coronavirus infection covid-19 (based on laboratory and/or computer tomography data); * need in respiratory support (oxygen insufflation, non-invasive lung ventilation, artificial lung ventilation, as well in a prone position); * ability to take food spontaneously in the amount of 60% and more of energy and protein needs (possibility of spontaneous food intake will be determined with the three-swallow test; consumed food will be controlled with the "quarter of a plate" method); * the informed consent is signed by a patient for the study enrollment and processing of personal data. exclusion criteria: * diabetes mellitus; * renal failure; * hepatic failure; * systemic disease; * active cancer; * poor survival prognosis. * aggravation of a patient's condition requiring his transfer to enteral feeding and/or parenteral nutrition; * occurrence of complications requiring surgical interventions; * patient's transfer for treatment to another inpatient unit; * complications induced by the product for additional nutrition support (diarrhea, nausea, vomiting); * withdrawal of the informed consent for the study enrollment and processing of personal data.

Keywords: covid-19 icu respiratory support quality of life physical recovery
study of neisvac-c vaccine to evaluate immunological interference with hepatitis b, inactivated polio and acellular pertussis vaccines in healthy infants

Conditions: Meningitis, Meningococcal

Summary: the primary aim of the study is to show that neisvac-c does not influence the seroconversion rates induced by hepatitis b (hep b), inactivated polio (ipv) and acellular pertussis (ap) vaccines in infants.


Eligibility criteria:
inclusion criteria: * male and female volunteers infants, aged 2 to 6 months * clinically healthy, (i.e. the physician would have no reservations vaccinating with a meningococcal c vaccine outside the scope of a clinical trial) * parent(s)/legal guardian understands the study and has provided written informed consent for his/her infant's study participation * parent(s)/legal guardian and infant will be available for the duration of the study exclusion criteria: * history of any vaccine-related contraindicating event (e.g. anaphylaxis) * rash or other dermatological condition at the injection site which could interfere with injection site reaction monitoring or lead to a dermatological reaction * subjects who have received or will receive other vaccine(s) ± 30 days before or after the study period * concurrent participation in or previous participation in a clinical trial with an investigational medicinal product * subjects who suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids, chemotherapeutics) that can be expected to influence immunological functions * subjects who have previously received a vaccination against hep b or meningococcal c * subjects who have received banked human blood or immunoglobulins within one month of study entry

Keywords: meningococcal vaccine meningococcal meningitis, serogroup c neisseria meningitidis
to evaluate the efficacy and safety of tislelizumab in combination with lenvatinib in patients with selected solid tumors

Conditions: Advanced Solid Tumor

Summary: this study includes 2 parts. part 1 is a safety run-in stage and part 2 is to assess the efficacy and safety of tislelizumab in combination with lenvatinib


Eligibility criteria:
key inclusion criteria: 1. signed informed consent form (icf) and able to comply with study requirements 2. histologically and/or cytologically confirmed advanced solid tumor types such as one of following: non-small cell lung cancer (nsclc), squamous cell carcinoma of the head and neck (scchn), colorectal cancer (uc), or renal cell carcinoma (rcc). 3. at least 1 measurable lesion per recist version 1.1 4. tumor tissue (approximately 10 unstained slides) for central laboratory assessment of pd-l1 status for the nsclc cohort during the screening period, and for retrospective analysis of other exploratory biomarkers related to response and resistance for nsclc, scchn, uc, or gc cohorts in a beigene designated central or test laboratory. 5. ecog performance status ≤ 1 key exclusion criteria: 1. for the nsclc cohort, active leptomeningeal disease or uncontrolled, untreated brain metastasis will be excluded. for other cohorts than nsclc, patients with known leptomeningeal disease or brain metastasis will be excluded. 2. prior therapy with lenvatinib or an anti-pd-1, anti-pd-l1, anti-pd-l2 or any other antibody or drug specifically targeting t-cell costimulation or checkpoint pathways 3. history of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including but not limited to pulmonary fibrosis, acute lung diseases, etc. 4. inability to swallow capsules or disease/procedure significantly affecting gastrointestinal function, such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction 5. have clinically significant bleeding (such as ctcae ≥ grade 2) within 21 days before first dose note: other protocol defined inclusion/exclusion criteria may apply

Keywords: solid tumors
clinical trial to evaluate the efficacy and safety of megacarti^® in knee cartilage defects

Conditions: Osteoarthritis, Knee

Summary: subjects aged 50 to 65 years with knee cartilage defects will undergo microfracture treatment for cartilage regeneration and megacarti\^® will be applied.

the megacarti\^® is the decellularized allogeneic cartilage and acts as a cover after bone marrow stimulation to prevent the loss of blood clots and induces cartilage regeneration by assisting in the location of stem cells derived from bone marrow. to evaluate cartilage regeneration, the study group is compared with the microfracture group alone through mocart evaluation at 48 weeks after treatment for cartilage regeneration. in addition, a biopsy is performed to evaluate the formation of hyaline cartilage and the area ratio of regenerated cartilage is measured.

Eligibility criteria:
inclusion criteria: 1. 50 years to 65 yaers 2. after receiving a detailed explanation of this clinical trial and fully understanding it, the subject or legal representative voluntarily decides to participate in the clinical trial and sign the consent form 3. subjects with localized full-thickness cartilage defects in the knee joint, international cartilage repair society(icrs) grade iii or iv 4. subjects whose primary lesion site can be designated as one section of the knee joint, and the area can be determined as the main cause of clinical symptoms 5. knee cartilage defect size :1.5cm\^2 to 10cm\^2 exclusion criteria: 1. patients who have autoimmune diseases (ex. rheumatoid arthritis) 2. when screening, patients who underwent surgery related to cartilage defect treatment, such as microfracture, autologous chondrocyte therapy within the past 1 year (however, arthroscopy for diagnostic purposes is possible. additionally, it is possible if hightibial osteotomy (hto) has been performed in advance or is scheduled) 3. when screening, patients who received intra-articular hyaluronic acid or steroid injections in the knee within 1 month 4. when screening, patients who took oral steroid within 2 weeks 5. patients who can't take mri scan 6. bmi index : 30kg/m\^2 or over 7. patients who have gout or gout history in the knee 8. women who are pregnant or breast-feeding, or women who have a possibility of pregnancy but do not use medically accepted methods of contraception. 9. patients with risk factor for bleeding 10. other than above, patients who are judged by medical investigator to be considered unsuitable for this clinical trial

Keywords: knee cartilage defects microfracture hto high tibia osteotomy megacarti cartilage regeneration
a prospective feasibility study for tamis

Conditions: Rectal Cancer

Summary: most recently, the transanal minimally invasive surgery (tamis) approach combined with single-port technology has allowed that pelvic surgery can be laparoendocopically performed from both its abdominal and perineal aspects.previously, a strong negative association between medium- and long-term survival and male gender with narrow pelvis have been reported. tamis has a significant potantial for improving the quality of the surgical resection of rectal tumors in men with visceral obesity and narrow pelvis. this group of patients have also a high rate of conversion to open surgery. focusing on improvement in intraoperative conditions and surgical techniques rather than routine conventional procedures may be the way to go concerning favorable short- and long-term outcomes. the selection of adequate surgical approach to the high-risk patients with visceral obesity and a bulky mesentery may prevent or limit the risk for anastomotic leakage and improve oncologic margin clearence. this is a prospective observational feasability study of the tamis-procedure.


Eligibility criteria:
inclusion criteria: * rectal cancer with histological diagnosis * tumors located between 10 - 4 cm from the anal verge measured with a rigid rectoscope. * suitable for elective resection exclusion criteria: * preoperative magnetic resonance imaging (mri) showing diameter of tumor size \>6 cm * american society of anesthesiologists (asa) class iv and v * anticipated need of intensive care unit (icu) * history of previous major abdominal surgery * computer assisted tomography (ct) or mri evidence of tumor infiltration of adjacent organs * obese patient with body mass index \>35kg/m2 * those, who do not understand the requirements of the protocol * pregnancy * more than one colorectal tumor
pregnenolone for cognitive and negative symptoms in schizophrenia

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: this study will investigate adjunctive pregnenolone for patients with schizophrenia and schizoaffective disorder.


Eligibility criteria:
inclusion criteria: * diagnosis: dsm-iv/dsm-iv tr schizophrenia or schizoaffective disorder; * gender: males and females; * age: 21-65; * caucasian or non caucasian; * capable of providing informed consent; * duration of illness equal to or greater than one year; * no change in antipsychotic medication in the previous eight weeks, no change in antipsychotic dose in the previous four weeks; * no benzodiazepine use in the past twelve hours prior to cognitive testing; * the patient cohort will be enriched for cognitive symptoms (composite bacs scores = 0-3 standard deviations below the mean, assessed at the screening visit). exclusion criteria: * subjects with a dsm-iv/dsm-iv tr diagnosis of alcohol or substance dependence (other than nicotine) within the last month; * subjects with a history of significant head injury/trauma, as defined by one or more of the following: * loss of consciousness (loc) for more than 1 hour, * recurring seizures resulting from the head injury, * clear cognitive sequelae of the injury, * cognitive rehabilitation following the injury; * subjects with unstable medical illness or neurological illness (seizures, cva); * patients with hormone-sensitive tumors (such as breast, uterine, or prostate cancer); * clinically significant abnormalities in physical examination , ecg, or laboratory assessments; * pregnant women or women of child-bearing potential, who are either not surgically-sterile or not using appropriate methods of birth control (serum beta-human chorionic gonadotropin \[hcg\] will be performed at baseline, 4 weeks, and 8 weeks to exclude pregnancy); * women who are breast-feeding; * electroconvulsive therapy (ect) treatment within the last 3 months; * use of oral contraceptives or other hormonal supplementation such as estrogen. although early studies suggested no effects on menstrual cycle, alterations in downstream metabolites of pregnenolone (such as estradiol) could theoretically impact the efficacy of oral contraceptives and/or estrogen replacement. similarly, it is theoretically possible that pregnenolone could be metabolized to other steroids, resulting in hair, skin, or other steroid-related changes. since we have determined in our prior study that pregnenolone administration does not result in downstream elevations in dhea, dheas, estradiol, or testosterone, these possibilities may be unlikely; * current active suicidal and/or homicidal ideation, intent, or plan; * known allergy to study medication.

Keywords: pregnenolone schizophrenia cognitive positive symptom negative symptom placebo control
wb-dw-mri vs choline-pet/ct for selecting treatments in recurrent prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to determine the effectiveness of whole-body diffusion-weighted magnetic resonance imaging (wb-dw- mri) in detecting metastases by comparing the results with those from choline-positron emission tomography-computed tomography (choline-pet/ct) in patients with metastatic/oligometastatic prostate cancer. patients with this disease profile who could benefit from treatment with stereotactic body radiation therapy (sbrt) were selected and their responses to these techniques were rated.

this was a prospective, controlled, unicentric study, involving 46 consecutive patients from our centre who presented biochemical relapse after adjuvant, salvage or radical treatment with external beam radiotherapy, or brachytherapy. after initial tests ( bone scintigraphy, ct, pelvic mri) 35 patients with oligometastases or without them were selected. 11 patients with multiple metastases were excluded from the study. wb-dw- mri and choline-pet/ct was then performed on each patient within one week. the results were interpreted by specialists in nuclear medicine and mri. if they were candidates for treatment with ablative sbrt (sabr) they were then evaluated every three months with both tests.

Eligibility criteria:
inclusion criteria: * prostate cancer histologic diagnostic after one treatment * 5 o less lessions * asimptomatic lessions * informed consent form signed exclusion criteria: * not capability to perform nmr os ct/pet scans
eeg as predictor of hd-tdcs effectiveness in long covid-19

Conditions: Coronavirus COVID-19; Respiratory Infection

Summary: covid-19 is an infectious disease which presents a heterogenous clinical presentation. recent investigations suggest that people who were infected by covid-19 often develop physical disabilities (i.e. pain, fatigue) and neurological complications after hospital discharge. many therapeutic approaches such as transcranial direct current stimulation (tdcs) have been proposed to minimize functional and structural impairments. electroencephalogram (eeg) has been used in this population to assess electrophysiological changes in the brain. however, evidences about eeg utilization as efficacy predictor of tdcs in covid-19 people rest inconclusive.our objective is to evaluate eeg as neurobiological predictor marker of tdcs efficacy on fatigue, pain, quality of life, self-efficacy and functional capacity in the chronic phase of covid-19.

a double-blinded randomized clinical trial will be carried to analyse the eeg as neurobiological predictor marker of hd-tdcs 4x1 in patients in long covid-19. this study is in accordance with the consort guidelines, which will investigate the effectiveness of treatment with hd-tdcs. patients who had a medical diagnosis of covid-19, clinically stable, able to respond to simple commands, able to walk for six minutes and who sign study consent form will be enrolled. those who present associated neurological diseases, pregnant, users of psychoactive drugs, patients who have metallic implants, electronic devices, pacemakers, or epileptic patients will be excluded. patients will be allocated randomly to the experimental group or sham control. sessions for experimental group consist of anodal hd-tdcs on left diaphragmatic primary motor cortex associated to respiratory training (10 sessions, 3ma, 20 minutes/session). in the sham condition, the device provided a 30-second ramp-up period to the full 3 ma, followed immediately by a 30-second ramp down. patients will be assessed in three moments: pre-treatment, post-treatment and after 30 days treatment ending (follow-up).

Eligibility criteria:
patients who had a medical diagnosis of covid-19, clinically stable, able to respond to simple commands, able to walk for six minutes and who sign study consent form will be enrolled. those who present associated neurological diseases, pregnant, users of psychoactive drugs, patients who have metallic implants, electronic devices, pacemakers, or epileptic patients will be excluded.

Keywords: transcranial direct current stimulation non-invasive brain stimulation electroencephalography machine learning covid-19 respiratory infection long covid