Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the safety and efficacy of cntx-4975 in subjects with painful intermetatarsal neuroma (morton's neuroma)

Conditions: Morton's Neuroma

Summary: subjects who have completed study 4975-mn-202 will be eligible to receive open-label treatment with cntx-4975 200 µg in study 4975-mn-203 if they meet the inclusion/exclusion criteria.


Eligibility criteria:
inclusion criteria: 1. male or female aged \>18 years at the time of the screening visit. 2. completion of study 4975-mn-202. 3. female not of childbearing potential, defined as post-menopausal for at least 1 year, or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or practicing one of the following medically acceptable methods of birth control throughout the study period: 1. hormonal methods such as oral, implantable, injectable, or transdermal contraceptives for a minimum of 1 full cycle (based on the subject's usual menstrual cycle period) before investigational product (ip) administration. 2. total abstinence from sexual intercourse since the last menses before ip administration. 3. intrauterine device. 4. double barrier method (condoms, sponge, diaphragm, with spermicidal jellies or cream). 4. willing and able to understand the study requirements, abide by the study restrictions, complete the study procedures, pain scales, and weekly iwrs/ivrs entries, and to communicate meaningfully with the study personnel. 5. signed an informed consent form approved by the institutional review board. 6. subject agrees to take only the rescue medications for neuroma foot pain from the time of screening through study completion, and agrees to discontinue all topical medications for neuroma pain after screening. exclusion criteria: 1. other chronic pain anywhere in the body that is severe in intensity or would interfere with the subject's ability to evaluate foot pain from intermetatarsal neuroma. 2. signs of arterial insufficiency in the feet, including clinically meaningful edema. 3. raynaud's disease or phenomenon, previous frostbite, or other cause of vascular instability in the feet resulting from application of cold to the foot. 4. daily use of opioids for any condition. 5. corticosteroid injection in the affected foot within 30 days of screening. 6. presence of any medical condition (or taking any medication) or unstable health status that, in the judgment of the investigator, might adversely impact the conduct of the study or resulting data, including chronic conditions that are likely to alter the rate of healing or are likely to result in safety complications unrelated to the study medication, such as uncontrolled diabetes mellitus or vascular disease. 7. clinically significant abnormal laboratory result at the screening visit (in the opinion of the investigator). 8. has a positive pregnancy test at the screening visit.
complex decongestive physiotherapy applied after lymphovenous anastomosis surgery

Conditions: Lymphedema; Cancer

Summary: type of this study: prospective randomized controlled study. the aim of our study is to compare patients with lymphedema who have undergone lymphovenous anastomosis surgery receiving complex decongestive physiotherapy (cdp), patients with lymphedema who have not undergone surgery who receive complex decongestive physiotherapy, in terms of extremity volume, quality of life and patient satisfaction. 26 volunteers will be included in the study as patients with lymphedema who have undergone lymphovenous anastomosis surgery and kbf (n=13), only kbf (n=13), application groups. how effective is lymphovenous anastomosis surgery and kbf or only cdp acutely in the treatment of lymhedema?

lymphedema (le) is a chronic and progressive condition that occurs as a result of abnormal accumulation of protein-rich fluid in the interstitial space due to inadequate lymphatic drainage. the gold standard treatment program among physiotherapy applications is the complex decongestive physiotherapy application. it consists of four basic components; manual lymph drainage, skin care, compression therapy, therapeutic exercise. all patients will receive the treatment phase of kbf for 20 sessions, 5 days a week: treatment; the 45-minute mld consists of skin care, compression therapy with a short-draft bandage that they will then use for 23 hours a day, decongestive exercises and suggestions to facilitate venous and lymphatic flow. the effect of cdp will be compared in patients who have had lymphovenous anastomosis surgery and those who have not. quality of life of patients related to lymphedema; lymphedema function, disability and health questionnaire-lower extremity (lymph icf-ll), satisfaction levels will be evaluated with the visual analog scale, and the amount of edema will be evaluated with circumference measurement.

Eligibility criteria:
inclusion criteria: * between the ages of 18-65, * having unilateral lower extremity or upper extremity lymphedema, * being diagnosed with stage 2 and 3 lymphedema, * receiving lymphedema therapy for the first time, * adjuvant chemotherapy for gynecological cancer, * having completed radiation and surgical treatment at least 3 months and at most 5 years ago, * patients with lymph vessels seen on lymphangiography, * patients who have undergone lva surgery and 1 month has passed since the surgery date * no evidence of disease recurrence at last follow-up visit and * individuals willing to participate in the study exclusion criteria: * those who do not volunteer to participate in the study, * those with bilateral lower extremity lymphedema, * having upper or lower extremity edema due to systemic disease, * those with active infection, * patients more than 1.5 months after lva surgery * known to have mental and cognitive disorders * those who were unable to communicate and cooperate were not included.
a phase iii trial comparing tisagenlecleucel to standard of care (soc) in adult participants with r/r follicular lymphoma

Conditions: Follicular Lymphoma (FL)

Summary: this trial will compare tisagenlecleucel to standard of care in adult participants with relapsed or refractory (r/r) follicular lymphoma.

the purpose of this phase iii study is to verify the clinical benefit of tisagenlecleucel for the treatment of r/r fl by comparing the tisagenlecleucel treatment strategy to standard of care therapy in patients with r/r fl after two or more lines of systemic therapy, with progression-free survival (pfs) as the primary endpoint. the primary objective is to demonstrate superiority of the tisagenlecleucel treatment strategy over standard of care (soc) therapy with respect to progression-free survival (pfs) determined by blinded independent review committee (birc) based on the lugano response criteria. participants randomized to arm a (tisagenlecleucel treatment) will receive a single infusion of 0.6 to 6 x 10\^8 car-positive viable t-cells. participants randomized to arm b (standard of care) will receive r2 or r-chop based on investigator choice and this has to be determined prior to randomization.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years at the date of signing the informed consent form. 2. follicular lymphoma grade 1, 2, or 3a confirmed histologically after latest relapse (local assessment). 3. relapsed or refractory disease after a second or later line of systemic therapy including an anti-cd20 antibody and an alkylating agent. 4. disease that is both active on positron emission tomography (pet) scan (defined as a score of 4 or 5 on the deauville 5-point scale) and measurable on computed tomography (ct) scan. 5. ecog performance status of 0, 1 or 2 at screening. 6. adequate hematologic, renal, hepatic and pulmonary organ function at screening. 7. must meet the institutional criteria to undergo leukapheresis (unless historical leukapheresis is available). 8. must be eligible for treatment with the selected standard of care regimen. exclusion criteria: 1. follicular lymphoma grade 3b or evidence of histologic transformation. 2. prior treatment with anti-cd19 therapy, gene therapy, or adoptive t-cell therapy. 3. active cns involvement by malignancy. 4. clinically significant active infection, presence of human immunodeficiency virus (hiv) antibody or active hepatitis b or c. 5. active neurological autoimmune or inflammatory disorders (e.g., guillain-barré syndrome). 6. investigational medicinal product within the last 30 days or five half-lives (whichever is longer) prior to randomization. 7. clinically significant cardiovascular conditions such as acute coronary syndrome, significant cardiac arrhythmias, heart failure or decreased lvef. other protocol defined inclusion/exclusion criteria may apply

Keywords: relapsed or refractory follicular lymphoma r/r fl car-t tisagenlecleucel ctl019 phase iii standard of care soc
a study of dayingpian treating bipolar disorder

Conditions: Bipolar Disorder

Summary: the main purpose of this cohort study is to evaluate the efficiency and safety of dayingpian to provide evidence-based medical evidence for the subsequent drug development.

dayingpian is a kind of formula in traditional chinese medicine with the effect of promoting blood circulation and reducing blood stasis. it has been prescribed as an add-on in the treatment of mental disorders such as bipolar disorder. however, there is not yet much high-quality evidence of the clinical effectiveness of dayingpian treatment. in this study, we conduct a prospective, real-world longitudinal cohort study at shanghai mental health center in china to investigate the efficacy and safety of dayingpian for bipolar disorder patients. the observation period is 12 weeks and all participants are evaluated every 4 weeks.

Eligibility criteria:
inclusion criteria: 1. meets the international classification of diseases-10(icd-10) criteria for bipolar disorder. 2. outpatients or inpatients in shanghai mental health center. 3. male or female subjects aged 14-65 years. 4. education of junior high school or above. 5. the patient fully understands and signs the informed consent form. exclusion criteria: 1. apparent violent aggression/suicide within the last two weeks. 2. other patients that the investigator believes should not be included in the study.

Keywords: cohort study bipolar disorder traditional chinese medicine efficacy dayingpian
intermittent hypoxia to enhance motor function after spinal cord injury

Conditions: Spinal Cord Injuries

Summary: this study will examine if acute intermittent hypoxia (brief episodes of breathing lower oxygen), which has been shown to enhance plasticity and motor output, can enhance functional outcomes and muscle activation in individuals with spinal cord injury. our aim is to assess breathing, sitting, standing and walking functional ability before and after acute intermittent hypoxia, compared to a sham treatment. this information may be useful in advancing rehabilitation for people with spinal cord injuries.

recent evidence has shown that acute intermittent hypoxia can strengthen motor pathways after spinal cord injury, and enhance walking outcomes after walking rehabilitation compared to walking rehabilitation alone. a single session of acute intermittent hypoxia has also been shown to temporarily enhance breathing and limb strength in people with spinal cord injury. further evidence supports the hypothesis that acute intermittent hypoxia acts on all motor pathways, and thus can enhance the strength of most muscles in the body. spinal cord injury affects the muscles that control respiration. decreased respiratory muscle function can lead to diseases of the respiratory system, which are the primary cause of death and significant cause of re-hospitalization after spinal cord injury. deficits in postural muscle function affect one's ability to balance, safely maintain a seated position, or ambulate after spinal cord injury, severely impacting daily activities such as self-care and feeding skills. this study will test the hypothesis that a single session of acute intermittent hypoxia will increase strength and activation of the muscles that control respiration and posture, leading to improved scores on functional assessments in individuals with chronic spinal cord injury. our long term goal is to better understand the therapeutic potential of acute intermittent hypoxia combined with physical rehabilitation for individuals with chronic spinal cord injury.

Eligibility criteria:
inclusion criteria: 1. male or female, ages 18-65 2. greater than 6 months post-spinal cord injury 3. spinal cord injury affecting segments between c4-t12 4. no other known neurological disorders 5. able to provide informed consent 6. no severe musculoskeletal impairments, open wounds, or skin lesions that would limit participation in functional assessments. exclusion criteria: 1. presence of a self-reported uncontrolled medical condition including, but not limited to: cardiovascular disease; sleep apnea; obstructive lung disease; severe neuropathic or chronic pain; severe recurrent autonomic dysreflexia 2. severe, untreated bladder or urinary tract infection 3. presence of severe musculoskeletal impairments, open wounds, or skin lesions that would limit participation in functional assessments 4. women who report being pregnant or test positive on a pregnancy test

Keywords: acute intermittent hypoxia breathing spinal cord injury motor function
myopia-control efficacy by peripheral defocus lens (pdl)

Conditions: Myopia, Progressive

Summary: the proposed study below aims to assess the effect of customized bestivue pdl lenses on retinal image quality and myopia control. a total of 160 subjected would be enrolled in and randomized to allcoate into four groups. visual acuity and image blur at various gaze directions and eccentricities on children fitted with +2 to 4 d power and single vision lenses would be measured to assess the short term effect of pdl lens. axial length and cycloplegic objective refractive error would be measured to assess the myopia-control efficacy.

the proposed study below aims to assess the short-term and long-term effect of customized bestivue pdl lenses on retinal image quality and myopia control. to these ends, two stages of testing are planned. first, objective testing will be utilized to assess the effect of bestivue pdl lenses on visual acuity and image blur at various gaze directions and eccentricities on 4- to 13-year-old children fitted with +2 to 4 d power and single vision lenses.in the second stage, the same children participants will wear either single or bestvue pdl lenses with one of the four plus power designs for 2 years. their corrected visual acuity, objective refractive error with dilation and axial length will be assessed for each eye every six months for two years. outcomes of these studies should inform whether bestivue pdl lenses are effective in myopia control while affording adequate visual comfort and performance.

Eligibility criteria:
inclusion criteria: * the subjects had spherical re of -1.00 to -6.00 d * astigmatism ≤ 4.00 d * anisometropia ≤ 1.50 d\\ * best corrected visual acuity (bcva) equal to or better than logmar 0.0 (20/20) in both eyes. exclusion criteria: * strabismus * ocular limitations * systemic abnormalities affecting vision and ocular motility.
modified frailty index for minimally invasive distal pancreatectomy

Conditions: Postoperative Complication

Summary: this study aims to investigate the difference in postoperative complications according to the modified frailty index (mfi) in patients who underwent minimally invasive distal pancreatectomy for pancreatic tumors at the asan medical center's department of hepato-biliary-pancreatic surgery from 2005 to 2019. it also seeks to confirm the utility of mfi as a predictive factor for postoperative complications in frail patients in the future.

distal pancreatectomy is a surgery performed to treat tumors in the distal pancreas. the minimally invasive approach to this surgery has become the standard due to its shorter hospital stay, quicker recovery, less pain, and similar complication rates compared to open surgery, especially for benign tumors. in selected patients with malignant tumors, minimally invasive distal pancreatectomy has gradually expanded to a state where it is not inferior to open surgery in terms of postoperative complications and long-term prognosis. as the average lifespan increases, elderly patients with comorbidities are steadily increasing in numbers among those who undergo distal pancreatectomy. however, predicting postoperative complications and mortality rates for these patients is still difficult. simple yet effective predictive factors for postoperative complications are needed. the canadian study of health and aging has created a standardized frailty index (csha-fi) as a tool for predicting frailty in elderly patients, and a modified frailty index (mfi) has been developed for easy use. the mfi has been reported as a predictor of postoperative morbidity and mortality rates after colorectal and vascular surgery. this study aims to investigate whether mfi can be used as a predictive factor for postoperative morbidity and mortality rates in patients who undergo minimally invasive distal pancreatectomy and to utilize it for clinical treatment in the future.

Eligibility criteria:
inclusion criteria: * the study population consists of patients who underwent minimally invasive distal pancreatectomy for pancreatic body or tail tumors between january 2005 and december 2019. exclusion criteria: * none
clinical study to compare efficacy and safety of avt06 and eu-eylea (alvoeye)

Conditions: Neovascular (Wet) AMD

Summary: this is a randomized, double-masked, parallel-group, multicenter, therapeutic equivalence study evaluating the efficacy, safety, and immunogenicity of avt06 compared with eylea in subjects with neovascular (wet) amd.


Eligibility criteria:
inclusion criteria: * subject must be ≥50 years of age, at the time of signing the informed consent. * subjects must be diagnosed with neovascular (wet) amd in the study eye. * subjects must have active, treatment naïve, subfoveal cnv lesions secondary to neovascular (wet) amd. * willingness and ability to undertake all scheduled visits and assessments. exclusion criteria: * any prior systemic treatment with anti-vegf therapy * any condition that, in the investigator ́s opinion, can interfere with full participation in the study, including administration of the study treatment and attending required visits; can pose a significant risk to the participant, or interfere with interpretation of study data * prior treatment with any investigational drugs within 30 days or 5 half-lives (whichever is longer) of the previous investigational treatment before initiation of the study treatment or concomitant enrollment in any other clinical study involving an investigational study treatment * subjects not suitable for participation, whatever the reason, as judged by the investigator, including medical or psychiatric conditions, or participants potentially at risk of noncompliance to study procedures.

Keywords: macular degeneration retinal degeneration aflibercept
non-weight bearing in hip joint with accompanying joint pain might not progress radiographic oa

Conditions: Hip OA

Summary: as we have previously reported, the primary cause of hip oa with accompanying joint pain might be bone alterations which can be microfracture. in order to prove it, it is planned that conservative treatment will be performed on the hip oa patients with accompanying joint pain for the first year. for the second year, if the patients still have joint pain, they will do non-weght bearing walk.


Eligibility criteria:
inclusion criteria: * hip oa, joint pain exclusion criteria: * obvious radipgraphic fracture in hip joint,
evaluation of a portable oxygen concentrator during ambulation for patients who require supplemental oxygen (poc-lean)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: prospective randomized study with a cross-over design. mobi™ is a relatively new poc in the market and thus it is valuable to collect data from copd patients using supplemental oxygen, and their use on mobi™. the purpose of the present study is to compare mobi™ with a continuous flow oxygen cylinder, with spo2 as the primary endpoint.


Eligibility criteria:
inclusion criteria: 1. informed consent obtained before any study-related activities. study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. 2. male or female, age ≥ 18 years at the time of signing informed consent. 3. diagnosed with copd and currently in a stable state (at least 4 weeks since last exacerbation episode22). 4. current prescription for long-term oxygen therapy. 5. participants meet the criteria for pulse-dose portable oxygen delivery, defined as being mobile within the home and the qualifying blood gas study was performed at rest/ awake or during exercise. 6. participants who can read and comprehend english. exclusion criteria: 1. clinically unstable, in the investigator's opinion, which might jeopardize the participant's safety or compliance with the protocol. 2. current oxygen therapy prescription for \>5 l/min continuous flow. 3. known or suspected contraindication for pulse-dose oxygen. 4. unable to complete 6mwts, e.g., unstable angina and myocardial infarction during the previous month 5. female who is pregnant, breast-feeding, or intends to become pregnant, or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice).
a trial to evaluate negative pressure incision management system for groin wounds in vascular surgery patients

Conditions: Surgical Procedure, Unspecified

Summary: the purpose of this research study is to investigate if a new negative pressure incision (surgical cut) management system, could reduce the occurrence of groin wound infections after vascular surgery. this is a single use, sterile dressing that is applied to the patient's skin. it has an attached battery-powered unit that provides negative pressure (a vacuum environment) to the dressing and a disposable canister for the collection of wound fluids. the patient is being asked to participate in this study because the patient is planning to have a vascular surgery procedure that involves groin incision.

surgical site infection (ssi) in groin wounds after vascular surgery is a significant contributing factor for increased morbidity. despite the use of prophylactic systemic antibiotics, postoperative groin wound infection still occurs in some circumstances and it continues to be a serious problem after vascular surgical procedures. the incidence of ssi varies from 5 - 40%, and depending upon the depth of infection and type of vascular procedure, the morbidity could range from prolonged hospital stay to limb loss. increased incidence of ssis in patients is related to systemic factors like diabetes, hypertension (htn), history of smoking, chronic obstructive pulmonary disease (copd), and local factors like disruption of lymphatics, groin proximity to the perineum, previous surgery at the same site and the use of prosthetic graft material. prophylactic systemic antibiotics have been routinely used in all vascular surgery procedures, and despite of gentle tissue handling, proper hemostasis and other technical points to minimize tissue trauma, ssis do happen. the investigators hypothesize that using a closed dressing system with negative pressure will keep the surgical site protected from nearby contaminated field and decrease the risk of infection

Eligibility criteria:
inclusion criteria: 1. older than 18 years 2. subjects are capable of giving informed written consent 3. undergoing a vascular surgery procedure that involves a groin incision at north shore university hospital and long island jewish hospital. exclusion criteria: 1. the patient has a history of blood clotting disorders 2. patient has evidence of infection in the groin area, where surgical procedure is planned 3. patient body habitus precludes placement of prevena dressing. 4. allergy to silver or acrylic adhesive

Keywords: prevena incision management system (pims) surgical site infection (ssi)