Kornimate/medical-research-clean huggingface dataset:
voiding function after mid-urethral slings with and without local anesthetic: randomized controlled trial

Conditions: Stress Urinary Incontinence

Summary: the purpose of this study is to determine if there is a difference in post-operative voiding function between subjects receiving local anesthetic and those receiving placebo at the time of mid-urethral sling placement. the secondary objective is to evaluate pain after the procedure in the two groups.


Eligibility criteria:
inclusion criteria: * scheduled to undergo mid-urethral sling for incontinence without concomitant procedures exclusion criteria: * undergoing procedure in addition to the sling * not competent to give consent * using intermittent self catheterization pre-operatively * known allergy to local anesthetic * undergoing spinal anesthesia for the procedure * prisoners * non-english speaker * under 18 years of age * has a condition that would contra-indicate the use of local anesthetic or epinephrine
cardiovascular-renal consequences of reducing renal mass after living kidney donation

Conditions: Kidney Failure; Hypertension; Albuminuria; Renal Failure; Inflammation; Endothelial Dysfunction

Summary: * a reduce in renal mass may result in remnant single nephron hyperfiltration, with associated proteinuria and an accelerated loss of kidney function. * live-donor kidney transplantation is generally considered the best choice for patients who have renal failure and are awaiting transplantation, because these kidneys function better than kidneys from deceased donors, and waiting times for deceased-donor transplants are long * although several studies have shown that kidney donation has low short-term morbidity and mortality, the data on long-term outcomes are much less complete. * this study is designed to prospectively evaluate the effects of unilateral nephrectomy on cardiovascular-renal functions of donors after living kidney donation: the development of hypertension, albuminuria, renal failure, inflammatory and endothelial changes.

renal dysfunction is associated with accelerated cardiovascular disease even when kidney function is only mildly impaired. besides, even levels of urinary albumin excretion below the accepted threshold for microalbuminuria are associated with increased cardiovascular risk, and the risk increases as the degree of proteinuria rises. * live-donor kidney transplantation is generally considered the best choice for patients who have renal failure and are awaiting transplantation, because these kidneys function better than kidneys from deceased donors, and waiting times for deceased-donor transplants are long. although several studies have shown that kidney donation has low short-term morbidity and mortality, the data on long-term outcomes are much less complete. the short and long term renal functions of donors after kidney donation were much studied and still remain uncertain, the cardiovascular effects of reduction in renal mass in kidney donors is also not clearly known. * endothelial dysfunction (ed) is the first step for subsequent development of atherosclerosis, which can help us to assess the cardiovascular changes after kidney donation. prospectively examining the endothelial consequences of uninephrectomy in donors may provide useful insight into the existence and pathophysiology of cardiovascular disease in donors and, therefore, into how the cardiovascular disease risk associated with renal impairment might eventually be reduced.

Eligibility criteria:
inclusion criteria: * living kidney donors * ages of 18 and 70 * creatinine clearance at donation \> 80 ml/min/1.73 m2 exclusion criteria: * low (\< 80 ml/min/1.73 m2) creatinine clearance at donation * diabetes mellitus * hypertension * valvular heart disease, any prior coronary intervention * congestive heart failure (new york heart association class ii or greater) * cardiac arrhythmia * a history of cerebral infarction or transient ischemic attack * active infection or non-infectious overt inflammation

Keywords: transplantation inflammation endothelial dysfunction
long-term effectiveness and immuno-persistence study of a recombinant hpv 16/18 bivalent vaccine in preadolescent girls

Conditions: Cervical Intraepithelial Neoplasia; Cervical Cancer; Persistent Infection

Summary: the primary objective of this study is to evaluate the protective efficacy against future infections of hpv types 16/18 or related diseases and immuno-persistence (type specific igg antibody) of the bivalent hpv vaccine in young female populations aged 9-17 years.

this is a follow-up study that is based on the bridging study of a recombinant human papillomavirus 16/18 bivalent vaccine in preadolescent girls(unique protocol id:hpv-pro-006,identifiers: nct02562508) . this study proposes to conduct a prospective cohort study based on the cohort population from the immunobridging clinical trial of the bivalent hpv vaccine (unique protocol id:hpv-pro-006,identifiers: nct02562508) . by matching control groups according to factors such as age and education level, and through long-term follow-up, this research aims to elucidate the protective efficacy of the bivalent hpv vaccine against future infections of hpv types 16/18/31/33/45 or related diseases in young female populations aged 9-17 years. additionally, the study will evaluate the persistence of vaccine-induced antibodies, investigate the potential for type replacement/competition phenomena post-vaccination and assess oral hpv infections in the cohort population.

Eligibility criteria:
inclusion criteria: * participants must be at least 18 years old; * participants who have participated in the immunobridging clinical trial of the bivalent hpv vaccine (unique protocol id:hpv-pro-006,identifiers: nct02562508) and have received at least one dose of the vaccine (only applicable to the vaccine group); * able to understand the study procedure and have the ability to comply with the protocol requirements (e.g., collection of biological samples and regular follow-up) and sign a written informed consent form; exclusion criteria: * participants who did not experience sexual debut;\* * participants with acute cervical inflammation and acute lower genital tract infection;\* * participants during menstruation, or have vaginal medication, sexual behavior within two days (48 hours) before the visit, which may affect gynecological examinations and specimens collection;\* * participants in the vaccine group have used other hpv vaccine products (including both marketed and unmarketed vaccines) after participating in the immunobridging clinical trial of the bivalent hpv vaccine (unique protocol id: hpv-pro-006, identifiers: nct02562508); participants in the control group have used hpv vaccine products (including both marketed and unmarketed vaccines); * according to the judgement of investigator, various medical, psychological, social, vocational or other factors that are not suitable for participating in the study. * note: for criteria marked with an asterisk (\*), if the participant meets that exclusion criterion, it does not affect the blood sample collection.

Keywords: human papilloma virus 16 human papilloma virus 18 adolescent girl long-term effectiveness immuno-persistence
stem cells therapy in advanced heart failure

Conditions: Congestive Heart Failure

Summary: stem cells therapy may be a choice therapy for advanced heart failure patients refractory to medical therapy, internal cardiovertor with a defibrillator (icd) recipients, and a previous history of myocardial infarction and coronary artery revascularization. these patients, without indication to receive a cardiac resynchronization therapy (crt), may have a worsening of heart failure, and symptoms of coronary artery disease. in this study we have evaluated in consecutive 30 selected patients the amelioration in failing heart nyha class, hospitalization rate, echocardiographic left ventricle functionality, and associated to reduction of angina after a treatment with stem cells intra thoracic infusion.


Eligibility criteria:
inclusion criteria: * heart failure post coronary artery disease, refractory to maximal medical therapy, previous coronary artery surgical revascularization. exclusion criteria: * inflammatory chronic diseases, neoplastic diseases.
chronic constipation with cerebral palsy

Conditions: Cerebral Palsy

Summary: this study was performed to evaluate posture, sleep, physical activity and quality of life in individuals with chronic constipation cerebral palsy.

the study included 81 individuals diagnosed with cp, 3-18 years of age and 2 groups with and without constipation according to rome iv criteria. general motor impairment levels with "gross motor function classification system, motor functions with "gross motor function measurement, functional independence levels functional independence measurement, spasticity modified ashworth scale , posture characteristics spinal aligment and range of motion measurement, with stool characteristics bristol stool form scale the presence and severity of constipation with the modified constipation assessment scale and constipation severity scale sleep quality with pediatric sleep questionnaire physical activity level physical activity scale and life quality was evaluated with pediatric quality of life inventory .

Eligibility criteria:
inclusion criteria: * volunteering to participate in research * being between the ages of 2-18 * being diagnosed with cerebral palsy exclusion criteria: * • having undergone surgery involving intestinal health * having a chronic infectious bowel disease * having a congenital bowel anomaly * having received botox treatment in the last six months

Keywords: cerebral palsy constipation physical activity posture quality of life sleep
adjunctive everolimus treatment of refractory epilepsy

Conditions: Epilepsy

Summary: this project is a prospective, randomized, placebo-controlled, double-blind study that will evaluate the clinical efficacy of everolimus as an adjunctive treatment in adult patients diagnosed with refractory epilepsy.

the project consists of a screening and baseline monitoring period of 1-2 weeks, and a treatment period of 1 week, followed by a 3-month follow-up period. approximately 108 participants will be randomized in a blinded manner to one of three arms in a 1:1:1 fashion (everolimus 1h : everolimus 8-9h : placebo). after screening, participants will have the first video-eeg monitoring for up to 24 hours to assess baseline levels, followed by 1 week of treatment, the second video-eeg monitoring, and a 3-month post treatment follow-up period. during the treatment period, participants will be given everolimus or placebo directed to seizure events. in the "everolimus 1h" group, everolimus will be administrated immediately after seizure events (within 1 hour); while in the "everolimus 8-9h" group, everolimus administration will be delayed (at 8-9 hours after seizure events). we conduct this study to assess the efficacy of everolimus in adult refractory epilepsy patients under an administration strategy in a limited time window immediately after seizure events.

Eligibility criteria:
inclusion criteria: * diagnosis of drug resistant epilepsy, with treatment of at least two approved anti-epileptic drugs (aeds), and having at least one reported seizure per month during the 3-month baseline phase and no continuous 3-month seizure-free period. * diagnosis of focal epilepsy without secondary generalization. * treatment with a stable dose of aeds that must have no drug interactions with everolimus (eg, valproic acid, topiramate, oxazepine, phenobarbital, phenytoin, and primidone) for at least 12 weeks before enrollment. exclusion criteria: * history of non-drug treatment for epilepsy, eg, vagus nerve stimulation (vns), ketogenic diet, and epilepsy surgery. * severe dysfunction in kidney. * with significant infectious, immunologic, or oncologic comorbidity at the time of enrollment. * currently taking or previously treated systemically with an mammilian target of rapamycin (mtor) inhibitor. * history of seizures secondary to drug abuse, psychogenic nonepileptic seizures, or an episode of status epilepticus within 1 year before enrollment.

Keywords: everolimus
ipack and adductor canal catheter patient outcomes for tkas?

Conditions: Surgery; Acute Pain

Summary: this study evaluates the addition of the ipack block to the adductor canal block and catheter in the pain management of total knee arthroplasty. half of participants will receive the adductor canal block and catheter with the ipack block, while the other half will receive the adductor canal block and catheter only.

total knee arthroplasty (tka) is a surgical procedure that can be associated with significant post-operative pain. poor pain control in the post-operative period has contributed to delays in early mobility and rehabilitation, an important part of recovery that is best started as soon as possible after surgery. regional techniques in general have helped manage post-operative pain as well as minimize narcotic use. the application of femoral and sciatic nerve blocks has been shown to decrease opioid use; however, they were associated with adverse events such as quadriceps weakness and falls post-operatively. this led to the development of the adductor canal block (acb) which has gained favor for providing superior analgesia over opioids alone, and for the added benefit of sparing the quadriceps muscle. recently, adding local anesthetic to the interspace between the popliteal artery and posterior capsule of the knee (ipack) blocks have been used to help address pain in the posterior part of the knee that is not well covered by the adductor canal block alone. while the sciatic nerve block is also an option to cover this area, it is associated with foot drop which can hinder early mobility. for patients undergoing tkas at ucla, our standard of practice is the acb. the investigators hope to show with this study that adopting this novel block will help with post-operative pain control, decrease length of hospital stay, and increase distance walked during physical therapy.

Eligibility criteria:
inclusion criteria: * patients undergoing total knee replacement without contraindications to regional blocks exclusion criteria: * patients who have contraindications to regional blocks: infection at injection site for the nerve block, allergy to local anesthetics, history of a bleeding disorder

Keywords: total knee arthroplasty regional block
mri study of the mechanisms underlying irreversible disability in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: multiple sclerosis (ms) is the first non-traumatic cause of disability in young people, responsible for physical but also cognitive deficits. ms is an inflammatory demyelinating and degenerative disease of the central nervous system. recently, mri technics have demonstrated their sensibility to the different processes involved in ms. particularly, mri has evidenced that the pathological process of ms is not restricted to the macroscopic lesions of the white matter but also involves the normal appearing white and grey matter. in the normal appearing brain tissue, demyelination, neuronal suffering and neuronal loss have been evidenced. moreover, mri has demonstrated the existence of brain functional reorganization processes that may limit the clinical expression of pathological injuries. despite these important findings, the pathological underpinnings of irreversible disability are largely unknown. the present project aims to depict the main determinants of physical but also cognitive disability in patients with ms. to do this, a longitudinal study including 70 patients with ms using different mri markers known to be sensitive to the different pathological aspects of ms will be performed. the relationships between these markers and the progression of disability will be assessed. identification of the main pathological underpinnings of irreversible disability of ms will provide the most relevant therapeutic targets.


Eligibility criteria:
inclusion criteria: * major patient, * patient affiliated to a health insurance plan * patient having signed free and informed consent after receiving detailed, understandable and honest information, * patient with multiple sclerosis according to the criteria of polman 2010 exclusion criteria: * patients with the usual contraindications to mri (pace-maker, agitation, metal splinters, claustrophobia etc.) * patients at risk of non-compliance on examination: impaired understanding, confusion, involuntary movements, poor tolerance of prolonged supine * patients with known allergy to gadolinium * patients with renal insufficiency * patients unable to give their consent: disorders of the comprehension, disturbances of vigilance, confusion ... * pregnant and breastfeeding woman * patients with a history of neurological or psychiatric pathology * patients under guardianship or curatorship
a post marketing surveillance study of cetuximab in patients with squamous cell carcinoma of head and neck (scchn)

Conditions: Carcinoma, Squamous Cell of Head and Neck

Summary: this is a prospective, observational, non-interventional, multicenter, post-marketing surveillance study to mainly collect safety information from subjects with locally advanced and recurrent/metastatic squamous cell carcinoma of head and neck (scchn) treated with cetuximab based on the locally approved label.

cetuximab is an immunoglobulin g1 (igg1) monoclonal antibody that enhances the effects of some common chemotherapy agents and radiotherapy and demonstrates minimal overlapping toxicities with these approaches. this prospective, observational, non-interventional and multi-centric post marketing surveillance study is being conducted to collect safety information from subjects with locally advanced or recurrent/metastatic scchn treated with cetuximab based on the locally approved label. study plans to enroll 200 to 300 subjects, who are eligible for cetuximab treatment according to the indication in the approved label of cetuximab by taiwan health authority. data related to subjects' demographics, relevant tumor history, and laboratory information (hematology, biochemistry) will be captured and analyzed descriptively. objectives primary objective: • to obtain safety information on the use of cetuximab in subjects with scchn according to the regulatory approved label and in a regular clinical setting secondary objectives: • to gather clinical efficacy information of the treatment

Eligibility criteria:
inclusion criteria: * histologically proven stage 3-4 locally advanced scchn (oropharynx, hypopharynx, larynx) or recurrent and/or metastatic scchn * age greater than or equal to 18 years * signed informed consent exclusion criteria: * subjects with known severe (grade 3 or 4; national cancer institute common toxicity criteria version 4.03) hypersensitivity reactions to cetuximab * subjects with contraindications for concomitantly used chemotherapeutic agents or radiation therapy, identified before initiation of cetuximab combination treatment

Keywords: carcinoma squamous cell erbitux cetuximab head neck
effect of myofascial release therapy in patients with cervical myofascial pain syndrome

Conditions: Myofacial Pain Syndromes

Summary: objectives: to investigate the effects of myofascial release therapy (mrt) on pain, number of trigger points (tp), pressure pain threshold (ppt), cervical range of motion (rom), neck disability, and quality of life in the neck pain due to cervical myofascial pain syndrome (mps). in this prospective study, patients in group i (n=30) underwent a standard physical therapy program. patients in group ii (n=30) additionally underwent mrt 3 days a week. before and on the 15th day after treatment, patients' pain was measured by visual analog scale (vas), tp numbers by palpation, ppts by pressure algometer, cervical rom by goniometer, disability by neck disability index (ndi) and quality of life by nottingham health profile (nhp) was evaluated.


Eligibility criteria:
inclusion criteria: * volunteer patients between the ages of 18-65 who complained of neck pain lasting more than 1 month and met the travell and simons criteria for the diagnosis of myofascial pain syndrome exclusion criteria: * presence of known infectious, inflammatory, tumoral, and advanced degenerative diseases that may cause neck pain, presence of pain reflected from internal organs, history of spine or shoulder fracture or surgery, presence of nerve root involvement findings due to cervical discopathy, having a history of neck manipulation or invasive procedures in the last 3 months.
qingdao: insulin pump follow-up program

Conditions: Type 1 Diabetes

Summary: the purpose of the study is to observe/ collect clinical data, subject users' feedback, and device data to better understand the real-life usage and acceptance of the 722 pump in type 1 diabetes subjects,\<18 years of age, and the role of insulin pump therapy in qingdao,china.

this is a prospective, multi-center, non-randomized and noninterventional post-market release study. subjects will participate in 2 phases with each phase requiring the subject to use the continuous subcutaneous insulin infusion (csii) pump over the course of the study. during the study, subjects and parent or legal guardian will be trained to wear the glucose sensor in the abdominal area for 3 days to transmit real-time (rt) data to the pump. the duration of each study phase is approximately 6 months.

Eligibility criteria:
inclusion criteria: * subject is age \< 18 years at time of screening * subject has a clinical diagnosis of type 1 diabetes * subject is willing to perform required sensor calibrations * subject is willing to wear the medtronic minimed paradigm® real time system continuously throughout the study * subject is a participant in the qingdao project. exclusion criteria: * subject is actively participating in an investigational study (drug or device) wherein he/she has received diabetes treatment from an investigational study drug or investigational study devices in the last 2 weeks * subject has known hypersensitivity to insulin or insulin infusion set(including tape) * subject has used the insulin pump and/or real time cgm/sensor within 90 days before the screening visit for more than 10 days in the outpatient setting: * for example, subjects who have used insulin pump and/or real time cgm/sensor in the inpatient setting will still be eligible for enrollment. * for example, subjects who have used insulin pump and/or real time cgm/sensor for 8 days in the outpatient setting within 90 days before screening visit will still be eligible for enrollment. * for example, subjects who have worn the insulin pump and/or real time cgm/sensor for 3 months in the outpatient setting a year before the screening visit will still be eligible for enrollment * subject has been treated with drugs with a known effect on bg within 8 weeks before enrollment other than diabetes medications such as insulin or oral anti-diabetic agents. * subject has any systemic disease or medical condition found on screening that may interfere with the safety of the patient and efficacy of the study treatment, in the opinion of the investigator, may preclude him/her from participating in the study. * subject is being treated for hyperthyroidism at time of screening * subject has taken any oral, injectable, or iv steroids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or iv steroids during the course of the study * subject is currently abusing alcohol9. any condition that either the investigator believes would interfere with study participation or evaluation of results.