Kornimate/medical-research-clean huggingface dataset:
cln-0045: safety, and efficacy of otx-tic in participants with open angle glaucoma or ocular hypertension

Conditions: Ocular Hypertension; Open Angle Glaucoma

Summary: to assess the safety, tolerability and efficacy of a single sustained release dose of otx-tic, a sustained release travoprost drug product, in subjects with primary open-angle glaucoma or ocular hypertension.

this is a prospective, multicenter, open label study, to evaluate the safety, tolerability and efficacy of otx-tic intracameral implant in subjects with primary open-angle glaucoma or ocular hypertension. the subjects will be followed for approximately 7 months (one-month washout and 6 months follow-up after injected of the otx-tic implant).

Eligibility criteria:
inclusion criteria: * have a documented diagnosis of ocular hypertension or primary open-angle glaucoma * have iop that is currently controlled as assessed by the investigator * have open, normal appearing anterior chamber angles as determined by gonioscopy exclusion criteria: * have closed angle glaucoma, narrow angle glaucoma, pseudoexfoliation syndrome, pseudoexfoliation glaucoma, pigment dispersion or pigmentary glaucoma, glaucoma diagnosis prior to 15 years of age, inflammatory, neovascular or other secondary * have a known or suspected allergy and/or hypersensitivity to a prostaglandin (i.e. travoprost), fluorescein or to any component of the study products
association of genetic polymorphism and acute kidney injury after liver transplantation

Conditions: Liver Transplantation

Summary: some of the liver transplantation recipients experience postoperative acute kidney injury due to various causes including genetic factors. prevention of postoperative acute kidney injury is essential for postoperative care in liver transplantation recipients. the aim of this study is to investigate the relationship between gene polymorphisms which have been known to be associated with postoperative acute kidney injury, and the occurrence of acute kidney injury after liver transplantation.


Eligibility criteria:
inclusion criteria: 1) adult patients scheduled for liver transplantation exclusion criteria: 1. patients on dialysis 2. patients not able to read, or understand the consent form 3. ethnicity, other than asian 4. patients refusal
safety and tolerability of anti-il-20 in subjects with rheumatoid arthritis

Conditions: Inflammation; Rheumatoid Arthritis

Summary: this trial is conducted in europe. the aim of this clinical trial is to investigate the safety and tolerability of the drug anti-il-20 in subjects with rheumatoid arthritis.


Eligibility criteria:
inclusion criteria: * informed consent obtained before any trial-related activities * a diagnosis of rheumatoid arthritis made at least 3 months prior to screening * active rheumatoid arthritis, characterised by a das28 equal or above 3.2 * methotrexate treatment (stable dose, equal or below 25 mg/week) for at least 4 weeks prior to study start (subjects receiving stable doses of oral corticosteroids, and/or non-steroidal anti-inflammatory drugs and/or acetaminophen and/or opioids according to prescribed recommended doses can be included) * male subjects and female subjects of non-child bearing potential exclusion criteria: * body mass index (bmi) less than 18.5 or above 35.0 kg/m2 * subjects with chronic inflammatory autoimmune disease other than rheumatoid arthritis * history of or current inflammatory joint disease other than rheumatoid arthritis * chronic or ongoing infectious disease requiring systemic anti-infectious treatment within 2 weeks prior to study start * past or current malignancy (as judged by the investigator) * clinically significant cardiac or cardiovascular disease * positive for human immunodeficiency virus (hiv), hepatitis or tuberculosis * blood donation or blood loss of more than 0.45l within 2 months prior to study start, or longer if required by local regulations * breast-feeding women
99mtc-mip-1404 for imaging prostate cancer: phase i clinical study to assess the image quality of a simplified kit formulation compared to a multi-step preparation of 99mtc-mip-1404

Conditions: Prostate Cancer

Summary: this trial is a single-blind, cross-over design. up to three patients with confirmed metastatic prostate adenocarcinoma and up to three healthy volunteers will receive two doses of 20.0 (± 3) mci of intravenously administered 99mtc mip 1404 (preparation a or preparation b). whole-body planar scintigraphic images will be acquired at various time points on the day of study drug administration. a pelvic spect/ct image will be acquired on the day of study drug administration. blood will be collected for pharmacokinetic measurements following study drug administration. each participant will receive an initial study drug administration (preparation a) and a second study drug administration (preparation b) approximately 7 to 21 days later. a final follow-up visit will occur approximately 2 - 3 weeks after the second study drug administration.


Eligibility criteria:
inclusion criteria: * male aged 21 years or older. * ability to provide signed informed consent and willingness to comply with protocol requirements. * participants must agree to use an acceptable form of birth control throughout the study period. participants must agree to use condoms for a period of seven days after each study drug administration, if engaged in sexual activity. additional inclusion criteria for metastatic prostate adenocarcinoma patients: * histologic diagnosis of prostate cancer by validated medical history (pathology report, if available). * evidence of metastatic disease demonstrated by a documented abnormal bone scan, ct scan, or mri * karnofsky performance is ≥ 60 additional inclusion criteria for healthy volunteers: * psa laboratory assessment within normal range (psa \< 4 ng/ml) * normal findings on a digital rectal examination * hemoglobin and hematocrit within normal range exclusion criteria: * received a radioisotope within 5 physical half lives of that radioisotope prior to study enrollment * have any medical condition or other circumstances which, in the opinion of the investigator, would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post dose follow-up examinations * participant is determined by the investigator to be clinically unsuitable for the study * serum creatinine ≥ 2.0 mg/dl * total bilirubin ≥ 2.0 mg/dl * liver transaminases ≥ 1.5 x uln * platelet count \< 100,000/mm3 * absolute neutrophil count (anc) \< 2,000/mm3 * hematocrit \< 30% or hemoglobin \< 10 g/dl additional exclusion criteria for metastatic prostate adenocarcinoma patients: * have received a permanent prostate brachytherapy implant within the last 3 months for 103pd implants; or 12 months for 125i implants * have had any other malignancies within the past year, other than basal or squamous cell carcinoma of the skin, in which the diagnosis and location have not been defined as clinically controlled or treated to complete response
the effect of mild traumatic brain injury on recovery from injury

Conditions: Traumatic Brain Injury; Trauma; Head Injury; Brain Concussion

Summary: mild traumatic brain injury (tbi) is a common injury that can produce significant functional sequelae and ongoing disabling symptoms. predicting who will have an uncomplicated recovery and who will suffer ongoing symptoms is difficult. this protocol evaluates the use of neuropsychologic testing after mild tbi in injured patients to attempt to objectively establish predictors of long term disability and functional recovery.

patients who are hospitalized and who have suffered mild tbi (loss of consciousness or post-traumatic amnesia; glasgow coma score 13-15; admitted within 24 hours of injury; able to read, speak, and understand english) who do not have pre-injury dementia or significant cognitive impairment will undergo computerized neuropsychologic testing using a previously validated tool that has been effective in sports-related mild tbi. sequential testing will be performed during recovery and patients who report disabling symptoms and/or functional impairment will be compared to patients who recover uneventfully. goal is to identify those parameters that predict early who may suffer long term sequelae or functional impairment and therefore benefit from early cognitive rehabilitation. secondary goals are to establish objective parameters for functional recovery after mild tbi.

Eligibility criteria:
inclusion criteria: * mild tbi * admitted within 24 hours of injury * able to read, speak,and understand english exclusion criteria: * expected to die of their injuries * pre-existing dementia or significant cognitive impairment * neurologically impaired and incapable of completing testing * physically incapable of using arms/hands to complete computerized testing

Keywords: traumatic brain injury head injury concussion neuropsychologic test
a phase 2 study of sitravatinib in combination with pd-(l)1 checkpoint inhibitor regimens in patients with advanced or metastatic urothelial carcinoma

Conditions: Urothelial Carcinoma; Urothelial Carcinoma Bladder; Urothelial Carcinoma Ureter; Urothelial Carcinoma of the Renal Pelvis and Ureter; Urothelial Carcinoma Urethra

Summary: the study will evaluate the clinical activity of pd-(l)1 checkpoint inhibitor regimens in combination with the investigational agent sitravatinib in patients with advanced or metastatic urothelial carcinoma.

sitravatinib is an orally-available, small molecule inhibitor of a closely related spectrum of receptor tyrosine kinases (rtks) including met, axl, mertk, vegfr family, pdgfr family, kit, flt3, trk family, ret, ddr2 and selected eph family members. nivolumab is a human igg monoclonal antibody that binds to the programmed cell death-1(pd-1) receptor and blocks its interaction with programmed cell death ligand-1 (pd-l1) and pd-l2, releasing pd-1 pathway-mediated inhibition of the immune response including anti-tumor immune response. combining an immunotherapeutic pd-l1 checkpoint inhibitor with an agent that has both immune modulatory and antitumor properties could enhance the antitumor efficacy observed with either agent alone. sitravatinib selectively inhibits key molecular and cellular pathways strongly implicated in checkpoint inhibitor resistance and therefore represents a rational strategy to enhance or restore anti-tumor immunity when combined with nivolumab, a checkpoint inhibitor therapy. pembrolizumab is a humanized igg4 monoclonal antibody that binds to the pd-1 receptor and selectively blocks its interaction with pd-l1 and pd-l2, releasing pd-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response. enfortumab vedotin (enfortumab) is an investigational adc that is comprised of a fully human anti-nectin-4 igg1 monoclonal antibody conjugated to mmae via a protease-cleavable linker. enfortumab binds to cells that express nectin-4 with high affinity, triggering the internalization and release of mmae in target cells, inducing cell cycle arrest and apoptotic cell death. early efficacy results from enfortumab in combination with pembrolizumab in frontline cisplatin-ineligible urothelial carcinoma in the ongoing ev-103 study have demonstrated encouraging activity with a safety profile that appears manageable and tolerable. addition of sitravatinib to this combination might further augment clinical activity by selectively inhibiting key molecular and cellular pathways strongly implicated in checkpoint inhibitor resistance.

Eligibility criteria:
inclusion criteria: * diagnosis of urothelial carcinoma * adequate bone marrow and organ function exclusion criteria: * uncontrolled tumor in the brain * unacceptable toxicity with prior checkpoint inhibitor * impaired heart function

Keywords: mgcd516 antineoplastic agents immunologic factors nivolumab tyrosine kinase inhibitor vegfr tam rtks pd-1 pd-l1 pembrolizumab enfortumab vedotin checkpoint inhibitors antibody drug conjugates adc
memantine and comprehensive, individualized management of alzheimer's disease and caregiver training

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to determine whether a comprehensive, individualized management approach with caregiver training and medication with memantine will alleviate symptoms in community dwelling patients with moderate to severe alzheimer's disease.

presently some 4.5 million people are afflicted with alzheimer's disease in the united states. at present pharmacologic treatment, although beneficial, is not curative. certain nonpharmacologic treatments have assisted caregivers of ad patients by reducing their stress and burden, and others have aided patients, by improving their mood and physical functioning. comprehensive, individualized approaches to improving alzheimer's patients' symptomatology and caregiver stress and burden have not been systematically investigated in alzheimer's patient care. this study seeks to train and counsel caregivers as well as develop an individualized, comprehensive management program that will seek to enhance the functioning of each patient participant. patients are randomly placed into one of two groups. both groups receive memantine and comprehensive evaluations at baseline, 4, 12,28 and 52 weeks. additionally, group 1 receives an individualized management program, which consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.

Eligibility criteria:
inclusion criteria: * patients, 50 years of age or greater, residing in the community * presence of a family and/or professional caregiver willing and able to participate in all aspects of this study * a diagnosis of probable alzheimer's disease by diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv) and nincds-adrda (mckhann,et al., neurology,1984;34: 939-944) criteria * a ct or mri brain scan and medical work up compatible with the dsm-iv and nincds-adrda diagnostic criteria for alzheimer's disease * mini-mental state examination scores of 3-14 * global deterioration scale stages of 5 or 6 * a stage of 6a or greater on the functional assessment staging instrument signifying the presence of dementia deficits in the ability to perform one or more basic activities of daily living exclusion criteria: * non-english speaking patients and/or caregivers * subjects with a diagnosis of dementia due to conditions other than alzheimer's disease. * subjects with a diagnosis of vascular dementia or a score greater than 4 on the modified hachinski ischemic rating scale * patients with a major depressive disorder * patients with clinically significant laboratory abnormalities * patients receiving investigational pharmacologic agents

Keywords: alzheimer's disease caregiver training caregiver counseling individualized management memantine dementia
epigenetic changes in head and neck cancer

Conditions: Head and Neck Cancer; Squamous Cell Carcinoma; Head and Neck Squamous Cell Carcinoma; Head and Neck Neoplasms

Summary: with this study, the investigators will investigate the epigenetic changes, which may contribute to the development of head and neck squamous cell carcinomas.


Eligibility criteria:
cancer group: inclusion criteria : * written informed consent * histologically confirmed oral squamous cell carcinoma exclusion criteria: * history of cancer * uncontrolled comorbidity control group: inclusion criteria : * written informed consent * normal buccal mucosal surface. * normal ent-examination exclusion criteria: * history of cancer * uncontrolled comorbidity
amg 162 in the treatment of bone loss in subjects undergoing androgen-deprivation therapy for non-metastatic prostate cancer

Conditions: Prostate Cancer

Summary: this study will evaluate amg 162 in the treatment of bone loss in subjects undergoing androgen-deprivation therapy for non-metastatic prostate cancer.


Eligibility criteria:
other criteria also apply

Keywords: prostate cancer bone loss with prostate cancer treatment of bone loss in patients undergoing androgen deprivation therapy (adt) for non-metastatic prostate cancer (pc).
a study to evaluate the safety, tolerability and preliminary efficacy of ssgj-705 monotherapy in patients with advanced malignant tumors

Conditions: Locally Advanced, Recurrent or Metastatic Malignancies

Summary: this study was an open-label phase i study to evaluate the safety, tolerability, pk profile and potential efficacy of ssgj-705 as a single agent in patients with advanced malignancies.

this study includes 4 parts: part 1 (dose escalation and dose extension for qw administration), part 2 (dose escalation and dose extension for q2w administration), part 3 (dose escalation and dose extension for q3w administration), and part 4 (indication extension, such as her2 expression, pd-l1 high expression, driver gene negative newly treated advanced nsclc, or other tumors).

Eligibility criteria:
inclusion criteria: 1. males and/or females over age 18 2. histologically and/or cytologically documented local advanced or recurrent or metastatic malignancies 3. eastern cooperative oncology group (ecog) performance status of 0-1. 4. expected survival \>3 months. 5. signed informed consent form. 6. must have adequate organ function. exclusion criteria: 1. any remaining aes \> grade 1 from prior anti-tumor treatment as per ctcae v5. 0, with exception of hair loss, fatigue, and grade 2 peripheral neurotoxicity. 2. pregnant or nursing women or women/men who are ready to give birth 3. symptomatic central nervous system metastasis. 4. allergy to other antibody drugs or any excipients in the study drugs. 5. severe dyspnea at rest due to complications of advanced malignant tumors, or needing supplemental oxygen therapy. 6. participated in any clinical study of medical devices or drugs within 1 month prior to screening (excluding non-intervention clinical studies or follow-up period of intervention clinical studies) . the above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Keywords: advanced malignancies
ani-guided intraoperative analgesia vs conventional intraoperative analgesia

Conditions: Postoperative Pain; Analgesia; Surgery

Summary: this study evaluates the effects of analgesia nociception index (ani)-guided intraoperative analgesia on postoperative pain in patients undergoing open gynecologic surgery.

postoperative pain is one of the most common postoperative complications and is significantly associated with patient's quality of recovery. analgesia nociception index (ani) is known to analyze the high frequency component of heart rate variability in relation to respiratory frequency, providing the objective information on the degree of pain. however, most previous studies conducted by using ani were observational studies or small-sized randomized controlled studies. in the present study, the investigators aimed to evaluate the effects of ani-guided intraoperative analgesia on moderate-to-severe postoperative pain by performing randomized controlled study.

Eligibility criteria:
inclusion criteria: * age ≥ 18 * elective open gynecological surgery * american society of anaesthesiologists physical status classification 1-3 exclusion criteria: * laparoscopic surgery or robot-assisted surgery * patients who had analgesic agents, anti-psychotic agents, anticonvulsants which were related to chronic pain * patients who had hypersensitivity to analgesic agents or medications related anesthesia. * patients who were required to have mechanical ventilation after surgery * patients who had arrhythmia * patients who transferred to the surgical intensive care unit immediately after surgery * pregnancy
vascular access choice and outcomes in the elderly and very elderly with end stage renal disease in china

Conditions: End Stage Renal Disease

Summary: the purpose of the study is to evaluate the clinical outcomes and cost-effectiveness of different vascular access(arteriovenous fistula, tunneled cuffed catheter and arteriovenous graft) in the elderly and very elderly with end-stage renal disease in china.


Eligibility criteria:
inclusion criteria: 1. the elderly and very elderly with end stage renal disease. 2. estimated glomerular filtration rate (egfr) \<20ml/min\*1.73m2 3. all study subjects agree to participate in the study and provide written informed consent. exclusion criteria: 1. patients' life expectancy is less than 2 years. 2. mental illness that makes the patients unable to complete the trial.

Keywords: hemodialysis arteriovenous fistula tunneled cuffed catheter arteriovenous graft elderly very elderly
a comparative study of incision closure methods for total knee replacement

Conditions: Total Knee Replacement Closure; Wound Closure

Summary: the aim of the study is to compare incision closure techniques for total knee replacement using a combination of state-of-the-art sutures with tissue adhesives or staples in an effort to identify the best approach with respect to time efficiency, cost, durability, dehiscence, microbial resistance and cosmesis. the hypothesis is that the combined suture/adhesive approach (sutures for capsule and subcutaneous layers, and tissue adhesive for the final cutaneous layer) or suture/staple approach will be significantly faster and of comparable durability as the conventional exclusive suture approach (sutures used for the capsule, subcutaneous, and cutaneous layers). this is a prospective, randomized, controlled, single site, unblinded (open label) study.


Eligibility criteria:
inclusion criteria: * inclusion criteria included 18 years or older * tka scheduled without a bilateral planned within one week of the initial surgery * willingness to attend prescribed physical therapy 3 times per week. exclusion criteria: * exclusion criteria included medical conditions or personal circumstances that would prevent participation and completion of physical therapy and follow-up visits * current participation in another clinical trial * preoperative systemic infections * uncontrolled diabetes, or diseases or conditions known to effect the wound healing process * known hypersensitivity to cyanoacrylate * formaldehyde, or the dye d\&c violet #2 * prior knee hardware fixation devices * prior knee incisions greater than 9cm, and arthrofibrosis as evidence by limited rom less than 80°.

Keywords: total knee replacement closure methods
sarcopenia and simplified geriatric assessment in lymphoma patients undergoing car-t cell therapy: the fil_sar-car project

Conditions: Non-hodgkin Lymphoma,B Cell

Summary: this is a multicenter prospective observational study lead by the fil on sarcopenia and sga as possible predictors of efficacy and toxicity outcomes in patients undergoing car-t cells treatment.


Eligibility criteria:
inclusion criteria: * adult patients (≥ 18 years old). * patients with b-cell non-hodgkin lymphoma scheduled to received car-t cell product according to agenzia italiana del farmaco (aifa) indications and technical data sheet of the drug * availability of a 18f-fdg pet/ct scan or a full dose ct scan (without contrast media) pre-treatment with cart * written informed consent voluntarily provided exclusion criteria: * patients not fulfilling the eligibility criteria

Keywords: non-hodgkin lymphoma,b cell car-t sarcopenia