Kornimate/medical-research-clean huggingface dataset:
peroneal and achilles tendon repair indications with clarix® cord 1k

Conditions: Peroneal and Achilles Tendon Tears

Summary: peroneal and achilles tendon tears are common diseases that present challenges to surgeons due to tendon adhesion complications. functional recovery is compromised by limiting post-operative range of motion, mobility, and can lead to considerable amount of post-operative pain for the patient. amniotic membrane tissue has demonstrated clinical success as an anti-inflammatory and anti-scarring agent and promoting wound healing towards regeneration. cryopreserved human amniotic membrane and umbilical cord (am/uc) tissue in the form of clarix® cord 1k has been used to treat over 5000 orthopedic patients. the investigators hypothesize that its use in peroneal and achilles tendon surgical repair will enhance the overall functional recovery of the patient.


Eligibility criteria:
inclusion criteria: 1. male and female patients 18 years to 80 years of age 2. confirmed tendon pathology via mri, if clinically necessary, with planned surgical repair that have failed conservative management (pt) for a minimum of 2 months for chronic and partial thickness tears; acute full thickness tears or tendon rupture immediately eligible. 3. willing to follow the instructions and complete the visits required. exclusion criteria: 1. psychologically unstable 2. acute infections that, in the opinion of the investigator, may complicate healing 3. currently receiving chemotherapy 4. systemic inflammatory arthritis or rheumatoid arthritis 5. uncontrolled diabetes as measured by a1c\>12 6. bleeding disorders 7. unable to provide informed consent 8. has received oral or parenteral corticosteroids or cytotoxic agents for seven consecutive days in the period of 30 days before surgery or has received a local steroid injection within 7 days of surgery 9. immunocompromised patients 10. active malignancy other than non-melanoma skin cancer 11. untreated alcohol or substance abuse issues at the time of screening 12. pregnant women at the time of randomization 13. currently enrolled or participated in another investigational device, drug, or biological trial within 60 days of screening 14. allergy to amphotericin-b or dulbecco's modified eagle medium (dmem). 15. will undergo significant concurrent procedures with the tendon procedures on the affected foot that, in the opinion of the investigator, may complicate healing or alter the post-operative visit schedule
local moxifloxacin and povidone iodine versus povidone iodine alone as a prophylaxis before eye operations

Conditions: Eye Infections

Summary: the hypothesis is that povidone iodine alone is sufficient for sterilization of the lacrimal sac and eye lids before intraocular surgeries. patients admitted for various intraocular surgeries will be randomly allocated to prophylactic local therapy with either moxifloxacin and povidone iodine or povidone iodine alone before surgery. lacrimal sac and eye lid cultures will be obtained before the local therapy and just before surgery.

over all 500 patients admitted for various intraocular surgeries will be included in the study. the study will be prospective, double blind, placebo controlled, and randomized. patients will be randomly allocated to prophylactic local therapy with either moxifloxacin and povidone iodine or povidone iodine alone before surgery. for patients treated with povidone iodine alone a placebo will also be given. lacrimal sac and eye lid cultures will be obtained before the local therapy and just before surgery. all patients will be followed for 6 weeks for symptoms and signs of infection. bacterial and fungal culture results will be compared between the 2 groups.

Eligibility criteria:
inclusion criteria: * age \> 20 years. * various intraocular surgeries exclusion criteria: * need for emergency therapy, immunosuppression, any malignancy, psychomotor retardation, drug and alcohol abuse.

Keywords: prophylaxis, intraocular surgery lacrimal sac eye lid no conditions
c terminal variants of fsh receptor

Conditions: Infertility

Summary: follicle-stimulating hormone (fsh) is used in medically assisted procreation, to induce an ovarian stimulation in women. however, the fsh dose that has to be injected is quite hard to adjust, because an excess of exogenous hormone could lead to very severe complications for patient. this hormone acts on its cognate receptor, the fshr, present on the granulosa cells surface, and which regulation involve the intra-cytoplasmic carboxy-terminus domain. the investigators first aimed to research in the c-terminus part of the receptor the presence of allelic variants that could explain the variations of response to fsh stimulation. the investigators also would want to complete the data already known on a functionally determinant single nucleotide polymorphism on 680 position in the c-terminus part of the hfshr. then, the investigators would analyze the entire sequence of the hfshr of patients presenting an unusual phenotype in response to fsh treatment, in order to detect a potential mutation involved in the receptor functionality. the results of this study could allow us to increase our knowledge on the hfshr physiology and functionality, in order to adjust treatment to the genetic profile of patients.


Eligibility criteria:
inclusion criteria: * patients above 18 years, * entering an ivf cycle * informed consent * nhs operative exclusion criteria: * no

Keywords: genotype phenotype genotypic variation between patients genotypic phenotypic relationships
blood management in orthopedic surgery

Conditions: Osteoarthritis

Summary: aim: to investigate whether the use of several transfusion alternatives (erythropoietin, the cell-saver or postoperative drainage and reinfusion systems) in patients undergoing elective total knee or hip replacement surgery can lead to allogeneic red blood cell (rbc) saving if a restrictive transfusion policy is used. study design: a prospective, double randomized, open, multicenter study in which patients are stratified according to their preoperative hemoglobin(hb) level: stratum i= hb between 6,1 and 8,2 mmol/l. these patients are first randomized for erythropoetin (epo) or no epo. stratum ii= hb of 6,1 and lower or 8,2 mmol/l and higher, are not eligible for epo and thus not randomized. patients in both strata will be randomized for three modalities: a cell saver (cs)(to wash, filter and reinfuse autologous shed blood) which is used intra- and postoperatively or a postoperative autologous reinfusion drainage system (d) only (to filter and reinfuse autologous shed blood) or a restrictive transfusion trigger only (controls). inclusion criteria: all orthopedic patients of 18 years and older being considered for a primary or revision total knee- (tkr) or total hip replacement (thr). outcome measures: primary outcome: number of allogeneic red blood cell (rbc) transfusions. secondary outcome: transfusion reactions, rehabilitation time, length of hospital stay (days), peri- and post-operative complications during hospitalization, quality of life, cost analysis

power/data analysis: in order to be able to detect a 75% reduction of allogeneic transfusions by epo and a reduction of 30% by autologous (shed blood) transfusions (cs or d) with a power= 0.9 and an alpha= 0.05, inclusion of 2250 surgery patients (in a worst case scenario of high standard deviations) are required for intention-to-treat analysis. knee surgery patients are not randomized for cell saver (no intra-operative blood loss).

Eligibility criteria:
inclusion criteria: * orthopaedic patients of 18 years and older being scheduled for a primary or revision total knee (tkr) or total hip replacement (thr). exclusion criteria: * patients who refuse homologous blood (e.g.jehovah's witnesses), * patients with untreated hypertension (diastolic blood pressure \> 95 mm hg), * patients with a serious disorder of the coronary artery, peripheral arteries and/or carotid arteries, * a recent myocardial infarction or cva, * sickle cell anaemia patients, * malignancy in the operated area, * pregnancy, * unsuitability for peri-operative anticoagulation prophylaxis, * known allergy to erythropoietin, * an infected wound bed, * revision of an infected prosthesis which is being treated with antibiotics, or * patients with difficulty understanding the dutch language (unable to give informed consent or patients who insufficiently control the dutch language).

Keywords: blood management orthopedic surgery elective randomized study adults hip replacement knee replacement
comprehensive geriatric assessment in elderly non-small cell lung cancer patients

Conditions: Lung Cancer; Non-small Cell Lung Cancer

Summary: lung cancer is responsible for one of the highest incidences of cancer-related mortality globally, and non-small cell lung cancer (nsclc) accounts for the biggest subtype of lung cancer. in recent years, the use of immunotherapy has revolutionised the management of nsclc, with better response rates and survival outcomes reported in the literature, compared to traditional cytotoxic chemotherapy. despite this, doubts remain regarding the true efficacy of immunotherapy in patients \> 75 years old, given that this age subgroup is mis-represented in prospective phase iii trials, in terms of numbers and baseline functional status, compared to real-world experience. furthermore, the use of immune checkpoint inhibitors (icis) is associated with a spectrum of immune-related adverse events (iraes), affecting a range of organ systems. once again, there are doubts about the safety of the use of these agents in patients \> 75 years old, and whether baseline performance status and comorbidities are good predictors of efficacy and safety outcomes in this elderly patient subgroup. comprehensive geriatric assessment (cga) and the vulnerable elders survey (ves-13) are assessment tools that provide a good indication of functional status in elderly patients, in a similar capacity to performance status and comorbidities. this study therefore aims to prospectively examine patients \> 70 years old with a diagnosis of nsclc, commencing immunotherapy. it will assess cga and ves-13 scores at baseline, and correlate this with certain outcomes such as the incidence of severe adverse effects from immunotherapy at 3 and 6 months, any admissions to hospital arising from immunotherapy toxicities (and the subsequent length of inpatient stay), and mortality within 30 days. in doing so, it will help to determine if cga and ves-13 scores can be used as a reliable indication of possible future efficacy and toxicity outcomes in this elderly patient subgroup.


Eligibility criteria:
inclusion criteria: 1. patients ≥70 years old with advanced nsclc due to start first or second line ici therapy. 2. patients able to give informed consent. exclusion criteria: 1. patients already on treatment with icis. 2. patients with cns or leptomeningeal spread / disease progression. 3. ecog performance status iii/iv. 4. patients with severe autoimmune diseases. 5. patients who are recruited and then stop treatment after receiving ≤3 cycles of ici therapy, secondary to disease progression.
role of metabolites in nicotine dependence (2) - 5

Conditions: Tobacco Use Disorder

Summary: the purpose of this study is to determine the effects of varying doses of cotinine on cigarette self-administration.

previous studies have shown that cotinine, a metabolite of nicotine, antagonizes some of the effects of nicotine. one study showed that nicotine eliminates some of the beneficial effects of the nicotine patch in reducing withdrawal symptoms. the purpose of this study was to examine the effects of cotinine. the results generally showed no effects on self-administration of cigarettes, although higher serum nicotine levels were observed on the highest doses of cotinine compared to placebo or lower doses of cotinine.

Eligibility criteria:
inclusion criteria: male/female subjects ages 21-45 yrs. inclusive, with a smoking history of at least 1 pack of cigarettes daily for at least 1 year. subject must be in good health as verified by medical history, screening examination, and screening laboratory tests. subject must provide written informed consent to participate in the study and be motivated to stop smoking for a short term. exclusion criteria: history of myocardial infarction, angina pectoris, sustained or episodic cardiac arrhythmias, symptomatic peripheral vascular disease, peptic ulcer disease or any other medical condition which the physician or investigator deems inappropriate for participation. insulin-dependent diabetes. pregnant or lactating, or not using adequate birth control methods. requirement of any form of regular psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and recent psychiatric history). chronic use of systemic steroids or antihistamines. skin sensitivity which would preclude use of a transdermal system. abuse of alcohol or any other recreational or prescription drug. use of any other tobacco products including smokeless tobacco and nicotine products. previous use of transdermal nicotine system. inability to fulfill all scheduled visits and examination procedures throughout the study period.

Keywords: nicotine dependence
effect of cpap in the worsening of renal function in early stages of chronic kidney disease (ckd)

Conditions: Chronic Kidney Insufficiency; Sleep Apnea

Summary: objectives: evaluate the effect of cpap to reduce the progression of chronic kidney disease or ckd (the decline of glomerular filtration rate is ≥ 30%) in patients with early-stage renal disease and sleep apnea syndrome (osas). other objectives are; determine the prevalence of osas in patients with early-stage renal disease and evaluate the changes in inflamatories markers and endothelial damage, the state of kdigo, cardiovascular events, mortality and cost-effectiveness analysis in cpap group versus non-cpap group patients. methods: a prospective, multicentric, randomized and controlled study will be carried out for 3 years. early-stage renal disease (g1-3 kdigo) and osas patients will be included. the investigators will make a respiratory polygraphy to determinate osas (ahi ≥15/h) and after that, the investigators randomized patients in 2 groups; cpap group and control group (non-cpap treatment). patients with ahi \<15/h (non-osas) will be the reference group and the half of these patients, randomly chosen, will be followed up at the end of the follow up. statistic analysis: the investigators will analyze the differences in glomerular filtration rate before and after the treatment, comparing the percentage of patients with ckd progression for both groups. the investigators will use the chi square test with raw data and adjusted for confounding variables using intention to treat analysis with imputation of missing values.

there is a bidirectional involvement between the chronic kidney disease (ckd) and sleep apnea syndrome (osas). the declining of renal function, the fluid overloading and the disturbance of ventilation control could cause sleep apneas. on the other hand, the nocturnal hypoxia in patients with osas has been associated with changes in the renin-angiotensin system and sympathetic nervous system and production of reactive oxygen species. these findings are relationed with the deterioration of kidney function.

Eligibility criteria:
inclusion criteria: * patients referred to the outpatient nephrology department with a diagnosis of chronic kidney disease stages g1-3 kdigo * older than18 years * habitual snoring or observed apneas * scale sleep sleepiness (epworth test) with 11 points or lower. exclusion criteria: * very debilitating chronic or neoplastic disease * respiratory failure (pao 2 \<55 mm hg). * other symptoms of suspected sleep disorder different from osas. * patients unable to perform self-administered questionnaires. * patients with\> 50% of central apnea or cheyne-stokes. * patients who do not sign the informed consent.

Keywords: cpap, chronic kidney disease, sleep apnea
dose-finding study of spk-8016 gene therapy in patients with hemophilia a to support evaluation in individuals with fviii inhibitors

Conditions: Adeno-Associated Virus (AAV); Blood Coagulation Disorder; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Factor VIII (FVIII); Factor VIII (FVIII) Deficiency; Factor VIII (FVIII) Gene; Factor VIII (FVIII) Protein; Genetic Diseases, Inborn; Genetic Diseases, X-Linked; Gene Therapy; Gene Transfer; Hematologic Diseases; Hemorrhagic Disorders; Recombinant; Vector; Inhibitors

Summary: spk-8016 is in development for the treatment of patients with inhibitors to fviii. this phase 1/2, open-label, non-randomized, dose-finding study to evaluate the safety, efficacy, and tolerability of spk-8016 in adult males with severe hemophilia a and no measurable inhibitor against fviii.


Eligibility criteria:
inclusion criteria: 1. be male and ≥18 years of age; 2. have clinically severe hemophilia a, defined as: 1. \<1% (\<1 iu/dl) endogenous fviii activity levels as historically documented by a certified laboratory or screening data results; or 2. 1-2% (1-2 iu/dl) endogenous fviii activity levels and \> 10 bleeding events per year (in the last 52 weeks prior to screening); or 3. 1-2% (1-2 iu/dl) endogenous fviii activity levels and on prophylaxis; 3. have had \>150 exposure days (eds) to any recombinant and/or plasma-derived fviii concentrates or cryoprecipitates 4. have no prior history of hypersensitivity or anaphylaxis associated with any fviii or iv immunoglobulin administration 5. have no measurable inhibitor against fviii as assessed by central laboratory, have no confirmed history of clinically significant fviii inhibitor, and no clinical signs or symptoms of decreased response to fviii administration (note: family history of inhibitors will not exclude study participation) 6. agree to use reliable barrier contraception after the administration of spk-8016 until notified by the investigator. exclusion criteria: 1. have active hepatitis b or c 2. have significant underlying liver disease. 3. have serological evidence of hiv-1 or hiv-2 with cd4 counts ≤200/mm3. participants who are hiv-positive and stable, with an adequate cd4 count (\>200/mm3) and undetectable viral load, and are on an antiretroviral drug regimen are eligible to enroll 4. have detectable antibodies reactive with aav-spark capsid 5. have history of chronic infection or other chronic disease 6. have been dosed in a previous gene therapy research trial within the last 52 weeks or with an investigational drug within the last 12 weeks 7. any concurrent clinically significant major disease (such as liver abnormalities or type i diabetes) or other condition that, in the opinion of the investigator and/or sponsor, makes the subject unsuitable for participation in the study; 8. unable or unwilling to comply with the schedule of visits and study assessments described in the clinical protocol.
cardiac biomarkers and mortality in critically ill patients with sars-cov-2 (covid-19)

Conditions: COVID-19

Summary: objective: to assess the prognostic value of high-sensitive cardiac troponin t (hs-ctnt) and n-terminal pro brain natriuretic peptide (nt-probnp) at icu admission in patients with coronavirus disease 2019 (covid-19). design: multicenter retrospective observational cohort study setting: three icus at three hospitals in occitanie, france. patients: adults (≥ 18 years old) with laboratory-confirmed covid-19 and at least one hs-ctnt measurement at icu admission, from march 9, 2020, to may 9, 2020.


Eligibility criteria:
inclusion criteria: - adults (≥ 18 years old) with laboratory-confirmed covid-19 and at least one hs-ctnt measurement at icu admission exclusion criteria: - age \< 18, pregnancy

Keywords: sars-cov-2 troponin hs-ctnt nt-probnp
the clinical outcomes of the arthroscopic and open modified broström operation in clai and gjl

Conditions: Ankle Sprains; Instability, Joint; Joint Hypermobility

Summary: investigators designed this randomized controlled trial to compare the clinical outcomes of open and arthroscopic modified broström operation for the treatment of clai and gjl.

the open modified broström operation is the first line to treat chronic lateral ligament instability (clai). arthroscopic techniques gain popularity for less invasivity, quick recovery to normal and sports activities, and the possibility to treat other intraarticular disorders. studies have shown significantly poor clinical and radiological outcomes and a higher rate of failure in patients with generalized joint laxity (gjl) than patients without after open modified broström operation. however, there is no study to compare the open and arthroscopic modified brostrom operation for patients with gjl and clai. so, investigators designed this randomized controlled trial. the primary outcomes are karlsson, american orthopaedic foot \& ankle society, and visual analogue scales. the secondary outcomes are anterior displacement and talar tilt angle in stress radiography, the rate of re-injury.

Eligibility criteria:
inclusion criteria: - clinical diagnosis of lateral ankle pain and instability beighton score ≥4 age with 18 to 60 years exclusion criteria: - patients with an acute or subacute ankle injury (within 3 months) injury of the deltoid ligament alignment of lower extremity greater than 5 degrees fractures of the lower extremity stage iii or iv osteoarthritis patients who refused to participate in the study

Keywords: chronic lateral ankle instability generalized joint laxity modified brostrom operation arthroscopic open
a cross-sectional investigation on characteristics of gastrointestinal symptoms in china

Conditions: Functional Gastrointestinal Disorders

Summary: the investigators will conduct a multicenter cross-sectional study to discover symptom characteristics, quality of life, severity of anxiety and depression, status of lactose intolerance and treatment satisfaction of current chinese medicine (cm) regimens of outpatients with fgids. in the meanwhile, the investigators will also analyze the characters of cm patterns and corresponding elements, then explore the potential relationship between cm patterns and fgids' subtypes.

this is a multicenter cross-sectional study to discover symptom characteristics, quality of life, severity of anxiety and depression, status of lactose intolerance and treatment satisfaction of current chinese medicine (cm) regimens of outpatients with fgids. afterwards, the investigators will explore the potential relationship between cm patterns and fgids' subtypes based on collected information. it is estimated that 4,632 outpatients from 18 centers across china will be recruited. various demographic and disease-related information will be documented, including name, gender, age, education level, marital status, job category, disease course, medical consultation experience, current cm regimens and rationale, and treatment satisfaction. patients will also complete a series of scales, containing, rome iv diagnostic questionnaire, patient-reported outcome (pro) scale, the 36-item short form survey (sf-36), hamilton anxiety scale (hama), hamilton depression scale (hamd), lactose food frequency questionnaire (lactose ffq) and cm pattern scale. the primary outcome will be the symptom characteristics of outpatients with fgids. secondary outcomes include population characteristics of fgid patients (quality of life, emotional status, lactose intolerance status, and satisfaction level of cm interventions), and potential association between cm patterns and fgids' subtypes.

Eligibility criteria:
inclusion criteria: * symptoms onset at least 3 months * meet the diagnostic criteria of fgids * informed consent and ability to read and understand questionnaires exclusion criteria: * combined with organic gastrointestinal diseases * appearance of gastrointestinal alarm symptoms * combined with mental disorders