Kornimate/medical-research-clean huggingface dataset:
tissium's nerve coaptation device first-in-human clinical trial

Conditions: Digital Nerve Injury

Summary: the purpose of this study is to collect initial safety and device performance data of the tissium's nerve coaptation device for the sutureless repair of digital nerve injuries of the hand in which there has been no substantial loss of nerve tissue. additional clinical measures that assess device performance, use, and patient reported outcomes will be collected to guide future study design and potential device modifications.


Eligibility criteria:
inclusion criteria: * patient undergoing a repair of a proper digital nerve of the hand; * 100% transection injury to the nerve under repair; * gap closure between the nerve ends can be achieved by flexion of the extremity without excessive tension; * clean surgical wound with sufficient healthy soft tissue that enables primary closure without adjunctive soft tissue procedures; * patient willing and able to provide a signed patient informed consent form; * patient willing and able to follow the study instructions and likely to complete all required study procedures and visits. exclusion criteria: * patient has a known allergy to the constituent polymer of the investigational device; * patient has a documented diagnosis of peripheral neuropathy; * patient has a history of neuropathic pain; * patient has a history of injury to the nerve being studied; * patient has is missing the contralateral digit or with a history of injury to the contralateral digit (comparison control area); * patient is pregnant or nursing * any patient with a diagnosis of type 1 diabetes mellitus;

Keywords: nerve repair digital nerve repair digital nerve lesion peripheral nerve injury peripheral nerve lesion peripheral nerve repair
smart textile solutions as biofeedback method for injury prevention for latvian football youth league players

Conditions: Sport Injury

Summary: lower limb injuries are the most common in youth football leagues, accounting for 72% to 93% of all injuries. the leading prevention program in football today is the fifa 11+ warm-up program, which reduces the risk of injury by 30%. evidence from several studies confirms the addition of feedback during training reduces the incidence of injury by 40% . recent studies have shown that the smart textile sock system is an objective, easy-to-use tool for real-time foot monitoring and is an interactive feedback tool for athletes. however, there is a lack of information on the impact of the objective feedback provided by the smart textile sensor socks system on the outcome measures of football players prevention programs. in the first phase of the project, a cross-sectional study involving youth league footballers will be conducted to identify the most effective feedback elements of the smart sock system. in the second phase, a pilot study will be conducted to evaluate the effectiveness of prevention exercises using the feedback provided by smart textile sensor socks. the results of the functional tests and the study outcomes will be selected as performance indicators to evaluate the smart textile sensor sock system. conclusions on the use of the smart textile sensor sock system as a feedback method for injury prevention in latvian youth football league players will be drawn based on the results obtained from the project.


Eligibility criteria:
inclusion criteria: 1. youth football league players; 2. agree to participate in the study; 3. age from 14 to 18 years; 4. understands and speaks latvian. exclusion criteria: 1. operative treatment in the lower limb within the last 9 months; 2. injuries or pain in the lower limb during the last 6 months; 3. disorders of the vestibular apparatus 4. presence of metallic implants in the sensor application areas.

Keywords: smart textile sock system youth athletes football soccer biofeedback injurie prevention
archer 1009 : a study of dacomitinib (pf-00299804) vs. erlotinib in the treatment of advanced non-small cell lung cancer

Conditions: Non-Small Cell Lung Cancer

Summary: this is a multinational, multicenter, randomized,double-blinded, phase 3 study comparing the efficacy and safety of treatment with pf-00299804 to treatment with erlotinib in patients with advanced non-small cell lung cancer, previously treated with at least one prior regimen. analyses of primary objective (progression free survival) will be done in two co-primary populations as defined in the protocol.


Eligibility criteria:
inclusion criteria: * evidence of pathologically confirmed, advanced nsclc (with known histology). * prior treatment with at least one and no more than two systemic therapy regimens (at least one must be standard chemotherapy for advanced nsclc). * adequate tissue sample must be submitted prior to randomization for tumor biomarker analyses. * adequate renal, hematologic, liver function. * ecog ps of 0-2. * radiologically measurable disease. exclusion criteria: * small cell histology. * symptomatic brain mets or known leptomeningeal mets. * prior therapy with agent known or proposed to be active by action on egfr tyrosine kinase or other her family proteins. * uncontrolled medical disorders.

Keywords: comparative study of pf-00299804 and erlotinib double-blind phase 3 trial of tki
telederm and bullous pemphigoid

Conditions: Bullous Pemphigoid

Summary: the purpose of the study is to improve the quality of future clinical trials in bullous pemphigoid (bp), the investigators will monitor repeated measurement data from patients with bp on standard-of-care treatments at four week intervals for four months.

the study team plans to recruit 45 subjects from the autoimmune blistering disease clinic at emory dermatology clinic. the plan is to improve the quality of future clinical trials in bullous pemphigoid (bp), the team will monitor repeated measurement data from patients with bp on standard-of-care treatments at four week intervals for four months. this time frame will allow completion of both aims in the three year time period. aim 1 will evaluate the bpdai scoring over time with specific reductions in the activity score as future outcomes for therapeutic response and assess changes in patient reported outcomes particularly related to pruritus for future clinical trial endpoints. aim 2 will focus on the development of teledermatology platform for improving patient recruitment and retention. the data from this proposal will be critical for future bp clinical trials and clarify gaps in the current knowledge related to the natural disease history of bp patients on standard-of-care therapies, changes in bpdai scores over time, and pruritus specific outcome measures to define the quality of life impact.

Eligibility criteria:
inclusion criteria: * males or females \> age 18 * clinical and histological confirmation of bullous pemphigoid including at least subepidermal separation on h\&e or a positive direct immunofluorescence along with indirect immunofluorescence which demonstrates staining to the roof on salt split skin or elisa positivity for bp180 and/or bp230 autoantibodies * baseline bpdai-tas \>5 exclusion criteria: * subjects who are unable to consent, language barriers, or other unspecified reason that in the opinion of the investigator makes the subject unsuitable for enrollment. subjects that do not meet all of the enrollment criteria may not be enrolled. any violations of these criteria must be reported in accordance with irb policies and procedures.

Keywords: bullous pemphigoid
impact of obesity on the pharmacokinetics of imipenem-relebactam in icu patients

Conditions: Obesity; Critical Illness

Summary: this study is an open-label, multiple-dose pharmacokinetic study of imipenem-relebactam conducted in 12 non-infected, obese icu patients.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years of age 2. admitted to the icu 3. bmi ≥40 kg/m2 and/or total body weight ≥120 kg 4. provide a signed and dated written informed consent prior to study participation exclusion criteria: 1. history of significant hypersensitivity reaction or intolerance to imipenem/cilastatin or carbapenem-based agents (doripenem, ertapenem, or meropenem +/- vaborbactam) 2. history of seizures and/or receiving 1 or more anti-epileptic agent 3. serum creatinine ≥1.5 mg/dl 4. estimated creatinine clearance (clcr) \<60 ml/minute as determined by cockcroft-gault equation: 5. actively receiving antimicrobial therapy for treatment of a confirmed or suspected infection 6. the subject has participated in a clinical trial and has received a drug or a new chemical entity within 30 days prior to the first dose of study medication 7. positive serum pregnancy test (for women of childbearing potential) 8. currently breast feeding 9. has previously participated in this study 10. concomitant use of valproic acid or divalproex sodium 11. any other condition that may make the patient unsuitable for the study in the judgement of the investigator
molecular analysis of bladder cancer

Conditions: Bladder Cancer; Bladder Neoplasms

Summary: this is a laboratory study where the investigators hope to look at chromosomal events implicated in bladder cancer.


Eligibility criteria:
inclusion criteria: * bladder cancer

Keywords: bladder cancer cancer, bladder urinary bladder cancer
study of tlbzt based herbal therapy plus chemotherapy for metastatic colorectal cancer

Conditions: Metastatic Colorectal Cancer

Summary: teng-long-bu-zhong-tang (tlbzt) is a modern anti-cancer herbal formula. experimental studies have confirmed the anti-cancer potential of tlbzt against colorectal cancer. this trial will evaluate the safety and efficacy of tlbzt based herbal therapy in combination with chemotherapy in patients with metastatic colorectal cancer.

a phase i/ii, multicentric,randomized, controlled clinical trial.

Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma of the colon or rectum with non-resectable metastatic disease; * ages between 18 and 70 years; * measurable lesion; * karnofsky performance status ≥ 60%; * estimated life expectancy of at least 6 months; * participants have no major organ dysfunction and chemotherapy contraindications: hemoglobin ≥90g/l, n \> 1.5×10\^9/l, platelet≥ 100×10\^9/l, normal liver and kidney function; * informed consent from the patient. exclusion criteria: * symptomatic brain metastasis; * adjuvant or neo-adjuvant treatment for non-metastatic disease in past 6 months; * serious disease of heart, liver, kidney with severe dysfunction; * serious complications, such as gastrointestinal tract obstruction and hemorrhage; * pregnancy or breast-feeding women; * mental or cognitive disorders; * be participating other drug trials; * who are allergic to the study drug.

Keywords: metastatic colorectal cancer chemotherapy traditional chinese medicine (tcm) teng-long-bu-zhong-tang
low-dose ct-based method for detection of subclinical anthracycline-induced cardiotoxicity

Conditions: Neoplasms

Summary: prospective single arm study to evaluate a low-dose ct-based protocol for early detection of myocardial dysfunction in 50 cancer patients undergoing anthracycline-based chemotherapy.


Eligibility criteria:
inclusion criteria: 1. ability to understand and the willingness to sign a written informed consent. 2. 18-75 year old patients with newly-diagnosed cancer scheduled to undergo anthracycline-based chemotherapy (minimum of 200 mg/m2 of doxorubicin or equivalent) at ucsd medical center. 3. women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. • a woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * has not undergone a hysterectomy or bilateral oophorectomy; or * has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months) 4. women of child-bearing potential must have a negative pregnancy test during the screening period. exclusion criteria: 1. prior chemotherapy with anthracycline; 2. persistent tachycardia (heart rate\>90); 3. lvef\<53% or history of cardiomyopathy or decompensated heart failure; 4. baseline gls below lower limit of normal (normal range varies depending on age and gender (23)) or inability to obtain meaningful strain data due to poor quality of echocardiographic images; 5. known unrevascularized coronary artery disease, myocardial infarction within 30 days of enrollment; 6. moderate or severe valvular heart disease; 7. prior allergy or intolerance to iodinated contrast; 8. renal failure (gfr\ 1.5); 9. cancer involvement of the heart.
evaluating tocilizumab for sever covid-19 infection in breast cancer vs. non cancer pateints

Conditions: Breast Cancer

Summary: to compare evaluating clinical outcomes for patients treated with with or without breast cancer patients comorbidity for sever covid-19 infection in breast cancer patients versus non cancer patients and evaluating tocilizumab efficacy versus traditional therapy

cancer patients considered to be one of the least population that can be considered lucky during covid 19 pandemic attributed that to long term treatment with chemotherapy, immunosuppression and multi comorbidities . women with breast cancer are more likely to get covid-19 infection rather than other type cancers . the co-existing of two diseases breast cancer and covid19 are very challengeable due to confusion and similarities found in clinical biomarkers to evaluate both diseases as ferritin, d dimers and c-reactive protein and all other immune response and cytokine storm syndrome especially including interleukin-6 (il-6) . using chemotherapy or any other cytotoxic drugs may exacerbate the severity of covid -19 infection as well as poor clinical outcomes and even death are expected . the anti-human il-6r monoclonal antibody (tocilizumab) was used first in china in patients with severe covid-19 and patients improved in different clinical outcome . in cancer patients particularly the issue is debatable about the benefits of receiving tocilizumab. clinical studies are going on such medication role in treatment of patients with severe covid 19 infection however, studies have not clearly addressed the role of tocilizumab breast cancer patient compared to non-cancer patients. this study aims to measure different clinical outcomes after using tocilizumab in sever covid 19 infection in breast cancer patients vs. non cancer patients

Eligibility criteria:
inclusion criteria: 1. patients admitted to icu with or without breast cancer (non-metastatic) comorbidity 2. age 18-85 years' old 3. moderate to sever confirmed covid 19 infection through pcr and ct 4. male or female 5. confirmed covid-19 by pcr 6. requiring icu admission 7. with evidence of severe covid-19 (at least 2 of the following): 1. fever \> 38c within 72 hours 2. pulmonary infiltrate on chest x ray /ground glass opacity 3. need for supplemental o2 to maintain saturation \> 92% 8. and at least 1 of the following: 1. ferritin \> 500 ng/ml 2. crp \> 50 mg/l 3. ldh \>250 u/l 4. d-dimer \> 1000 ng/ml 9. all patient assigned informed consent exclusion criteria: 1. above 85 years' old 2. metatastic breast cancer 3. autoimmune disease patients 4. unable to provide verbal informed consent 5. preganncy 6. subjects between the ages of 70 and 75 will be excluded if they have nyha class iii/iv heart failure 7. active tb 8. receipt of iv tocilizumab for the treatment of a non-covid condition within 3 weeks of the first covid symptom 9. history of hypersensitivity to tocilizumab 7. anc \ 5x uln
the cold fluids study

Conditions: Hemodynamic Instability

Summary: in this single center crossover study the aim is to investigate the effect of ringer's lactate solution at high and low temperatures on physiological response in healthy adults.18 healthy volunteers will be included. inclusion criteria is; age between 18-64. exclusion criteria is; pre-existing medical problems, pregnancy (validated through a certified pregnancy test), body mass index \>35 kg/m2, medication use apart from allergy medication, contraceptives, or non-steroidal anti-inflammatory drugs. participants will be randomized to receive 30 ml/kg of ringer's lactate either cold (15°c, 59°f), or at body temperature (37°c, 98.6°f) during a 30-minute interval. fluids will be administered through a peripheral vein. after a minimum "washout period" of 24 hours, subjects are switched to receive infusion at the other aforementioned temperatures. primary outcome is * the increase in map at 15 minutes after infusion of the fluid bolus. secondary outcome is * time until return of map to baseline value after infusion.


Eligibility criteria:
inclusion criteria: * age between 18-64 exclusion criteria: * pre-existing medical problems * pregnancy (validated through a certified pregnancy test) * body mass index \>35 kg/m2 * medication use apart from allergy medication, contraceptives, or non-steroidal anti-inflammatory drugs.
post-transplantation cyclophosphamide in haploidentical stem cell allografts dose reduction: 50 mg/kg vs 25 mg/kg

Conditions: Graft Vs Host Disease

Summary: allogeneic hematopoietic cell transplantation (hsct) is a worldwide recognized therapy for several hematologic malignancies; a modality extensively used around the world due to its effectivity; however, an hla-matched sibling or unrelated donor is not always available, because of diverse factors such as: ethnic minorities and multiethnic families, socio-economic status, among others. this problem has led to an expansion of the donor pool to include alternative donor sources such as hla-haploidentical (haplo) relatives, hla-mismatched unrelated donors, and hla-matched or mismatched cord blood. in the hematology and internal medicine center of clinica ruiz, we have seen that 50% reduced doses of post-transplantation cyclophosphamide (25 mg/kg) on days +3 and +4 have a favorable effect on patient's survival rates compared to the full 50 mg/kg doses. haplo-hsct can be conducted safely on an outpatient basis, using peripheral blood stem cells, this leading into substantial decreases in the costs. outpatient-based haplo-hsct has turned into the solution of the hsct most frequent problems in low- and middle-income countries (lmic): cost and donor availability. the high dose administration of pt-cy after transplant can lead into hematological and cardiac, toxicities. there is preliminary information about diminished doses of ptcy, might being equally effective in the prevention of gvhd and substantially less toxic.


Eligibility criteria:
inclusion criteria: * candidates to receive a haplo-hsct (myeloid acute leukemia, lymphoid acute leukemia, myelodysplastic syndrome, multiple myeloma, hodgkin lymphoma, non-hodgkin lymphoma, myeloid chronic leukemia, medullary hypoplasia, non-malignant hematologic diseases). * patients able to travel to and remain in puebla, méxico during a 4-week period, accompanied by a caregiver. exclusion criteria: * patients who refuse to sign the consent form. * latent infection. * hepatic, cardiac or bronchopulmonary symptomatic diseases * abnormalities on previous clinical hematological appointments, considered as contraindication. * positive serology for hiv, vhb, vhc
crt versus surgery for retroperitoneal or paraaortic lymph node recurrence of crc

Conditions: Colorectal Cancer; Retroperitoneal Lymph Node Metastasis; Para-aortic Lymph Node Metastasis

Summary: the study aims to compare the effects of chemoradiation versus radical surgery in treating retro-peritoneal or para-aortic lymph node metastasis in colorectal cancer. by prolonging patients' progression-free survival, local control rate and overall survival, investigators can conclude the best regimen for colorectal cancer patients.


Eligibility criteria:
inclusion criteria: * a medical history of colorectal cancer * pathological or clinical diagnosis of retroperitoneal/para-vascular lymph node metastases, and located below the level of renal veins. * the treatment target is no evidence of disease (ned), including 3 cohorts: a. initial treatment (primary lesion + retroperitoneal ln oligometastasis); b. postoperative retroperitoneal/paravascular ln oligometastase; c. postoperative retroperitoneal/paravascular ln metastasis with other organ metastases (up to ned) * ecog ps 0-2 * ability to follow the program during the study period * signing written informed consent exclusion criteria: * retroperitoneal ln metastasis is above the level of the renal vein. * unable to reach ned. * previous pelvic radiotherapy, the field of irradiation overlaps with this time. * pregnancy or breastfeeding women. * those with other history of malignant disease in the last 5 years, except for cured skin cancer and cervical carcinoma in situ. * if there is an uncontrolled history of epilepsy, central nervous system disease or mental disorder, the investigator may determine that the clinical severity may hinder the signing of informed consent or affect the patient's oral medication compliance. * clinically severe (ie, active) heart disease, such as symptomatic coronary heart disease, new york heart association (nyha) class ii or more severe congestive heart failure or severe arrhythmia requiring medication intervention, or a history of myocardial infarction in the last 12 months * organ transplantation requires immunosuppressive therapy * severe uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases * subjects blood routine and biochemical indicators do not meet the following criteria: hemoglobin ≥ 90g / l; absolute neutrophil count (anc) ≥ 1.5 × 109 / l; platelets ≥ 100 × 109 / l; alt, ast≤2.5 times normal upper limit; alp≤2.5 times normal upper limit; serum total bilirubin \<1.5 times normal upper limit; serum creatinine \<1 times normal upper limit; serum albumin ≥30g/l

Keywords: chemoradiotherapy retroperitoneal lymphadenectomy imrt sbrt
zoledronic acid with intermittent hormonal therapy in patients with prostate cancer

Conditions: Urologic Neoplasms

Summary: primary: to determine the duration of use of zoledronic acid in improving bone mineral density in patients with prostate cancer who are on hormones intermittently. secondary objectives: to describe the safety and tolerability at this dose and schedule


Eligibility criteria:
inclusion criteria:patients: who are 18 years of age and older who have histologically documented adenocarcinoma of prostate who are currently receiving lhrh agonists kps greater than 80%life expectancy greater than 6 months provide written consent pursuant to regulatory requirements prior to initiation of study procedure exclusion criteria:exclusion criteria: patients: any patient requiring continuous lhrh any patient who has had an orchiectomy any patient with painful bone metastases who have received chemotherapy for prostate cancer who have a abnormal serum creatine \>2.5 receiving any investigational drug within the last 28 days severe uncontrolled infection, diabetes, cardiac disease patients with fragility fractures, hyperparathyroidism, pagets renal osteodystrophy will be excluded history of non compliance to medical regimens or unwillingness to return for medical visits