Kornimate/medical-research-clean huggingface dataset:
safety study of pegph20 given to patients with advanced solid tumors

Conditions: Solid Tumor

Summary: open-label, multicenter, dose-escalation, safety, pharmacodynamic, and pharmacokinetic study.

this is a study of pegph20 in human subjects and is designed to evaluate the safety of pegph20 and to determine the maximum tolerated dose of pegph20. all patients will receive pegph20. each group of patients will receive a higher dose than the previous group. this will continue until the group with the highest planned dose completes the study or until a group has major side effects from their assigned dose.

Eligibility criteria:
inclusion criteria: * pathologic (histologic or cytologic) confirmation of metastatic or locally advanced solid tumor. * patients who have experienced disease progression after receiving appropriate standard / approved chemotherapy and for whom no further standard or palliative treatment measures exist, or who have chosen to decline standard or palliative treatment. * one or more tumors measurable by recist criteria. * karnofsky performance status ≥ 70%. * recovery from any toxic or other effects of all previous therapy, including radiation, chemotherapy and surgery. * negative serum or urine pregnancy test result in women of childbearing potential. * for men and women of child-producing potential, agreement to use effective contraception (hormonal or barrier birth control or abstinence) from the time of screening before study entry and throughout study participation. exclusion criteria: * brain metastasis. * new york heart association class iii or iv cardiac disease, myocardial infarction, or cardiac arrhythmia requiring medical therapy. * known allergy to hyaluronidase. * serious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions including psychiatric illness) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor. * women currently breast feeding. * concurrent participation in any other interventional therapeutic study.

Keywords: pegph20 pegylated recombinant human hyaluronidase metastatic or locally advanced solid tumor
biomarkers for prediction of hand function after stroke - the prohand study

Conditions: Stroke; Hemiparesis

Summary: the overall aim is to identify key determinants for recovery of hand function after stroke by applying newly developed hand function measures together with mri measurements of the lesioned cerebral structures.

almost half of surviving stroke patients are left with impaired function of the hand but individual profiles of weakness, spasticity, sensory and bimanual function vary widely. improved prediction of recovery after stroke has broad implications for clinical decisions on the type, duration and goals of rehabilitation. 100 consecutive patients with 1st ever stroke and upper limb hemi-paresis will be subject to imaging, at 4 weeks and 6 months, and behavioral assessments at 4 weeks, 3 months and 6 months after stroke. the imaging protocol includes anatomical sequences for lesion mapping, diffusion tensor imaging and resting-state functional mri for structural and functional connectivity analyses, respectively. clinical hand function measures will be combined with novel validated methods to quantify spasticity,grip force control, sensory and bimanual function. prohand will provide insights into neural mechanisms related to recovery of hand function after stroke and enable enhanced prediction and development of targeted treatment trials.

Eligibility criteria:
inclusion criteria: * first ever stroke and clinically diagnosed arm paresis exclusion criteria: * incapability to give informed concent and/or understand and comply with instructions, other disorders that may affect hand function (e.g. other neurological conditions, arthritis), cerebellar lesions.

Keywords: prognosis hand function rehabilitation spasticity mri
the predictive value of ct-pet in esophageal cancer

Conditions: Esophageal Neoplasms

Summary: a major focus of research in oncology is to identify patients who, following induction therapy, have a complete pathologic response, presenting opportunities for novel trials, including extended therapy or non-operative approaches, in addition to identifying cohorts who are resistant to the neoadjuvant therapy. the current gold standard for determining response to crt is pathological evaluation following surgical resection, in particular the mandard tumour regression grade (trg) or some modification thereof. at this time, however, there is no preclinical early response or post-treatment biomarker, nor endoscopic or radiologic assessment that predicts pathologic response prior to surgical resection.the aim of this study is to determine the accuracy of ct-pet for prediction of histopathologic response and/or oncologic outcome for patients with esophageal cancer.


Eligibility criteria:
inclusion criteria: * locally advanced esophageal or junctional neoplasm * histologically confirmed adenocarcinoma or squamous cell carcinoma * scheduled to undergo ncrt followed by surgery as per multidisciplinary tumor board * ct-pet at diagnosis of malignancy (within 2 weeks from diagnosis), performed at study center * ct-pet 4-6 weeks after completion of ncrt, prior to surgical resection exclusion criteria: * incomplete data, patient lost to follow-up * scans performed at alternate center

Keywords: positron-emission tomography neoadjuvant therapy chemoradiotherapy esophagectomy response evaluation criteria in solid tumors treatment outcome survival recurrence disease-free survival progression-free survival prognosis neoplasm grading adenocarcinoma squamous cell carcinoma neoplasm metastasis
a diagnostic study of the advanced endoscopy to detect early esophageal cancer

Conditions: Esophageal Neoplasms

Summary: this descriptive cross sectional study aims to directly compare the diagnostic capability of the probed-based confocal laser endomicroscopy (pcle) and the magnifying narrow band imaging (m-nbi) in the lugol's voiding lesions.


Eligibility criteria:
inclusion criteria: * age over 20 years * having histological-confirmed diagnosis of head and neck cancer * having no esophageal symptoms exclusion criteria: * having index cancer of nasopharynx * history of esophageal surgery * having esophageal stricture or obstruction * having esophageal varices * known case of esophageal cancer * uncorrectable coagulopathy and thrombocytopenia * pregnancy * thyrotoxicosis * creatinine clearance less than 30 ml/min * allergy to iodine or fluorescein.

Keywords: confocal laser endomicroscopy narrow band imaging lugol chromoendoscopy esophageal neoplasm head and neck cancer
covid-19 vaccine response in elderly subjects

Conditions: Covid19 Vaccine

Summary: the objective of this research is to assess the amplitude and quality of the vaccine response against sars-cov-2, defined here by its characteristics established at 3 months, and its persistence over time, defined here at 9 months, in subjects residing in medical establishment for dependent elderly persons, compared to immunocompetent subjects aged 40 to 65 years (control subjects for vaccination over the same period).


Eligibility criteria:
inclusion criteria: target population. * elderly persons \> 65 years old residing in an institution for the elderly or in a long-term care unit for whom an anti-sars-cov-2 vaccination is indicated as recommended by french health authority (has) * male or female resident in an institution for the elderly or in a long-term care unit * for whom consent has been obtained prior to any sars-cov-2 vaccination (or from the legal guardian/curator) by comirnaty®. * having consented to participate in the study, and willing to comply with all study procedures and its duration * socially insured patient control population * health and medico-social sector professionals aged between 40 and 65 years old for whom a comirnaty® anti-sars-cov-2 vaccination is indicated as recommended by the has. * male or female between 40 and 65 years of age included * for whom consent has been obtained prior to any comirnaty® sars-cov-2 vaccination. * having consented to participate in the study, and willing to comply with all study procedures and its duration * socially insured subject exclusion criteria, for both groups : * progressive infectious pathology * progressive neoplastic pathology (or remission of \< 5 years) * treatment with long-term corticosteroids or immunosuppressants * refuse of consent to vaccination or study

Keywords: sars-cov-2 vaccination immunosenescence
heading off peripheral neuropathy with exercise

Conditions: Peripheral Nervous System Disorders; Breast Neoplasms; Chemotherapy

Summary: chemotherapy for the treatment of breast cancer can affect nerves and muscles leading to loss of sensation in the hands and feet for feeling hot and cold, difficulty walking, and muscle weakness. this study will explore if exercises such as walking and strength training may prove helpful in preventing or lessening chemotherapy-induced peripheral neuropathy from chemotherapy, making the therapy easier to tolerate and increasing overall quality of life.

this pilot study will test the effects of a tailored home-based walking (aerobic) and strength training (resistance) exercise program for individuals receiving taxane-based chemotherapy for breast cancer on neuropathy, breast cancer-related symptoms, cold thermal sensation, vibratory sensation, gait \& balance, upper and lower extremity muscle strength, and quality of life. the objective of this pilot study is to determine the effect size, feasibility and acceptability of a 12-week combination exercise program consisting of aerobic exercise (walking) and strength training for preventing or ameliorating the clinical manifestations and symptoms of cipn in individuals with stage i-iiia non-metastatic breast cancer.

Eligibility criteria:
inclusion criteria: * age 19 or older with newly diagnosed stage i-iiia invasive breast cancer who are to be treated with a taxane-based chemotherapy regimen (with paclitaxel or docetaxel) and thus are at risk for the development of cipn. exclusion criteria: * any disease (e.g. diabetes, hiv) that results in peripheral neuropathy; * any disease or disorder that results in muscle weakness (such as chronic fatigue syndrome, multiple sclerosis, spinal cord tumors or injuries, stroke, preexisting cardiopulmonary disease); * any disease or disorder that would preclude strength training exercises (such as bone metastasis, osteoporosis); * individuals with diagnosed lymphedema or advanced disease (\> stage iiia, or metastatic disease) at high risk for bone metastases and pathologic fracture will be excluded.

Keywords: breast cancer chemotherapy-induced peripheral neuropathy exercise
ai mobile app vs self exercises in workers with neck pain

Conditions: Neck Pain; Work-Related Condition

Summary: this study aims to compare the impact of two different methods to administer self-exercises in administrative workers with neck pain: an artificial intelligence embedded mobile application and written sheet.


Eligibility criteria:
inclusion criteria: * the presence of a chronic np lasting for more than three months, and a pain level at baseline assessment ≥ 30 (vas) exclusion criteria: * acute neck pain, neck pain from specific causes (eg; chronic inflammatory diseases), spine trauma or surgery, cervical radiculopathy or myelopathy, and physical therapy treatments in the last six months before baseline assessment.

Keywords: office workers clinical trial protocol exercise therapy mobile application neck pain patient compliance self-management workplace
next generation cataract surgery study

Conditions: Cataract

Summary: the purpose of this study is to obtain device-specific safety and performance clinical data to support marketability in europe and to collect user preference data.

subjects will attend a screening visit (day -60 to day 0), a surgery visit (day 0), and 3 post-surgical visits (day 1, week 1, month 1) for an overall individual duration of up to 3 months. one eye (study eye) will be treated. this study will be conducted in the united states.

Eligibility criteria:
key inclusion criteria: * able to understand and sign an irb/iec approved informed consent form. * willing and able to attend all scheduled visits as required by the protocol. * clinically documented diagnosis of age-related noncomplicated cataract. * eligible to undergo primary hydrophobic acrylic intraocular lens implantation into the capsular bag. * other protocol-defined inclusion criteria may apply. key exclusion criteria: * women of childbearing potential as defined in the protocol. * planned postoperative procedures during the course of the study in the operative eye. * previous intraocular or corneal surgery in the operative eye. * diagnosis of glaucoma or ocular hypertension (iop \> 21 mmhg) in the operative eye. * other protocol-defined exclusion criteria may apply.

Keywords: anterior segment ophthalmic surgery
the efficacy and safety of a novel adjunctive pacing strategy during rotational atherectomy

Conditions: Coronary Artery Disease; Coronary Artery Calcification; Bradycardia

Summary: coronary artery narrowings interfere with blood flow to the heart which can cause chest pain and heart attacks. cardiologists can treat these narrowings with balloons and stents. however, some narrowings can become very calcified and hard making treatment with balloons and stents difficult. rotational atherectomy is a tool to treat calcific coronary disease. it uses an ablative drill to break down the hardened plaques inside the coronary arteries facilitating subsequent treatment with balloons and stents. however, during this procedure patients can experience a slow heart rate which may compromise procedural safety. cardiologists may use a temporary pacemaker that is inserted by separately accessing the heart through a large vein usually from the leg. this maintains a safe heart rate throughout the procedure. however, inserting the temporary pacemaker is associated with additional complications. we have developed and propose an alternative strategy to provide a temporary safety pacemaker during rotational atherectomy without the need for inserting an additional pacemaker.


Eligibility criteria:
inclusion criteria: * age 18-90 years * undergoing percutaneous coronary intervention for angina or acute coronary syndrome. * calcific coronary disease requiring rotational atherectomy exclusion criteria: * pre-existing pacemaker or implantable cardioverter defibrillator. * mobitz ii heart block or complete heart block.

Keywords: coronary artery calcification rotational atherectomy temporary pacemaker
intrapleural cryotherapy for malignant pleural mesothelioma

Conditions: Mesothelioma

Summary: can neoadjuvant intrapleural cryotherapy be safely performed in patients with malignant pleural mesothelioma and will it trigger substantial systemic and local pro-inflammatory changes, resulting in the induction of anti-tumor immunity?

patients that have been diagnosed, or are suspected of having malignant pleural mesothelioma, a cancer of the pleura, surgery may be considered as an attempt to treat the cancer. as part of the testing needed before surgery, a pleuroscopy or video camera examination of the pleura is necessary to establish the diagnosis and/or to evaluate the extent of the cancer. this study evaluates the effects of cryotherapy (freezing spray) on the ability of a patient's immune system to attack the cancer, as has been reported in other types of cancers. the purpose of this research is to gather information on the safety and effectiveness of cryotherapy in patients with malignant pleural mesothelioma. if successful, this study could provide support for future studies evaluating this new treatment for mesothelioma.

Eligibility criteria:
inclusion criteria * subject provides informed consent * subject is \>18 years of age * subject is deemed competent for making medical decisions * subject is scheduled to undergo pleuroscopy as part of their standard care for pre-operative clinical staging of malignant pleural mesothelioma * a negative pregnancy test is required in women of child-bearing potential, as standard of care. * subject is mentally capable of understanding study procedures. exclusion criteria study subject has any disease or condition that interferes with safe completion of the study including: * platelet count \ 1.5 * anticoagulants such as clopidogrel, heparin, low-molecular weight heparin, warfarin or other novel anticoagulants have not been held for the standard time period published * hemodynamic instability with systolic blood pressure \ 120 beats/min, unless deemed to be stable with these values by the surgical or interventional pulmonary attending physicians. * hypoxemia with pulse oximetry values \<88% or partial pressure of oxygen in arterial blood (pao2) \< 60 on baseline oxygen requirements. * concurrent participation in another study involving investigational drugs or investigational medical devices * absence of or limited access to the pleural space during medical pleuroscopy. * inability to read and understand the necessary study documents.
imagery rescripting and imaginal exposure for social anxiety: mechanisms and outcomes in an analog sample

Conditions: Social Anxiety

Summary: this study will recruit 100 participants who self-report high symptoms of social anxiety (social phobia inventory \>30). participants will be randomly assigned to receive either one analog intervention of imagery rescripting (ir) or imaginal exposure. we will test the efficacy and mechanisms behind each interventions.

after being informed about the study potential risks, all patients giving written informed consent will undergo screening to determine eligibility for study entry. they will be randomly assigned to two conditions (imagery rescripting vs. imaginal exposure) at a 1:1 ratio. participants will attend three \~1 hour online zoom sessions (pre-assessment and measurement, intervention, and post assessment and measurement). assessors will be blind to the treatment condition.

Eligibility criteria:
inclusion criteria: spin scores \>= 30 - exclusion criteria: can't report a negative imagery related to a future social scenario. attending active psychotherapy sessions. -

Keywords: social anxiety symptoms
safety and efficacy of talactoferrin in previously treated patients with non-small cell lung cancer

Conditions: Non Small Cell Lung Cancer

Summary: the purpose of this study is to determine whether talactoferrin can improve overall survival in patients with non-small cell lung cancer (nsclc) who have been previously treated with two or more regimens.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed stage iiib or iv nsclc * failed at least 2 prior systemic anti-cancer regimens for advanced or metastatic nsclc * at least one target lesion that is unirradiated and measurable by recist * adequate hematologic, renal and hepatic function * ecog 0, 1, or 2 * able to understand and sign an informed consent exclusion criteria: * presence of brain metastases, unless the patient received brain irradiation, including adequate stereotactic radiosurgery, at least 4 weeks prior to randomization, and is stable, asymptomatic, and off steroids for at least 3 weeks prior to randomization * any gastrointestinal tract disease or other medical condition resulting in the inability to take oral medications * history of other malignancies except: (i) adequately treated basal or squamous cell carcinoma of the skin; (ii) curatively treated, a) in situ carcinoma of the uterine cervix, b) prostate cancer, or c) superficial bladder cancer; or (iii) other curatively treated solid tumor with no evidence of disease for ≥ 5 years * uncontrolled ischemic heart disease, or uncontrolled symptomatic congestive heart failure * serious active infection * psychiatric illness/ social situations that would limit study compliance * other uncontrolled serious chronic disease or conditions that in the investigator's opinion could affect compliance or follow-up in the protocol * concurrent radiotherapy to any site or radiotherapy within 4 weeks prior to randomization or previous radiotherapy to the target lesion sites (the sites that are to be followed for determination of a response) * known hiv positive or on active anti-retroviral therapy * known hepatitis b surface antigen positive or hepatitis c positive * receipt of any investigational medication within 4 weeks prior to randomization * pregnant or lactating patients, or fertile female patients with a positive pregnancy test, or fertile female patients unwilling to use adequate contraception during treatment and 30 days after completion of treatment * sexually active male patients unwilling to practice contraception while participating on the study and up to 30 days after completion of treatment * legal incapacity or limited legal capacity, unless authorization is granted by a legal guardian

Keywords: non small cell lung cancer talactoferrin dendritic cell recruiter and activator immunomodulatory agent
3-year follow-up of clinical outcome after antipsychotic treatment discontinuation in psychosis individuals

Conditions: Schizophrenia; Schizophrenia Relapse; Schizophrenia Spectrum and Other Psychotic Disorders

Summary: this open-label, non-randomized, prospective study will evaluate the risk of symptoms recurrence during the three years after antipsychotic discontinuation in a sample of functionally recovered first-episode patients with schizophrenia spectrum disorder.


Eligibility criteria:
inclusion criteria: * individuals included in the first episode psychosis clinical program (pafip) at the university hospital marqués de valdecilla (santander, spain). * a minimum of 18 months on antipsychotic treatment. * meeting clinical remission criteria for at least the 12 months prior to inclusion. * meeting the functional recovery criteria for at least the 6 months prior to inclusion. * stabilized at the lowest effective doses for at least the 3 months prior to inclusion. exclusion criteria: * meeting diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv) criteria for drug dependence. * meeting dsm-iv criteria for mental retardation. * having a history of neurological disease or head injury.

Keywords: treatment maintenance
phase 3, randomized, placebo-controlled study of tinlarebant to explore safety and efficacy in adolescent stargardt disease

Conditions: Stargardt Disease 1

Summary: the primary objective of this trial is to assesses the efficacy of tinlarebant in slowing the rate of growth of atrophic lesion(s) in adolescent subjects with stgd1

approximately 90 subjects will be enrolled in this study. subjects will be assigned to study drug (tinlarebant 5 mg/placebo) with treatment period of upto 24 months with 28 days of follow-up.

Eligibility criteria:
inclusion criteria: * male or female subjects 12 to 20 years old, inclusive. * subject must have clinically diagnosed stgd1 (stargardt disease 1) with at least 1 mutation identified in the abca4 gene. * subject must have a defined aggregate atrophic lesion size within 3 disc areas (7.62 mm2), as imaged by faf in the study eye subjects must have a bcva of 20/200 or better for the study eye based on etdrs letter score * subject and their parent(s) or legal guardian are willing to provide their consent on an institutional review board (irb)/independent ethics committee (iec)/human research ethics committee (hrec)-approved informed consent form (icf) prior to participating in any study-related procedures. * subject agrees to comply with all protocol requirements. exclusion criteria: * any ocular disease other than stargardt (stgd1) at baseline that, in the opinion of the investigator, would complicate assessment of a treatment effect. * history of ocular surgery in the study eye in the last 3 months. * investigational drug use of any kind in the last 3 months or within 5 half-lives of the investigational drug, whichever is shorter. * any prior gene therapy. * vitamin a (retinol) deficiency as defined as a retinol serum level less than 20 mcg/dl (=0.7 μmol/l).