Kornimate/medical-research-clean huggingface dataset:
post-approval safety monitoring program to assess the safety profile of gardasil in china usual practice

Conditions: Cervical Cancer

Summary: this is a post-approval safety monitoring program to assess the safety profile of gardasil in china usual practice.


Eligibility criteria:
inclusion criteria: * any person who is intended to be inoculated with first dose gardasil based on his/her own wishes at screening exclusion criteria: 1. unable to provide written informed consent 2. any woman who is known being pregnant at screening 3. subject who is participating or going to participate in another study which involves gardasil administration

Keywords: vaccine safety
the valve-ai trial

Conditions: Valvular Heart Disease Patients

Summary: the goal of this clinical trial is to learn if an artificial intelligence-powered electrocardiogram (ai-ecg) can help detect moderate or severe valvular heart diseases (vhds) in adults. the main question it aims to answer is: ．can ai-ecg screening identify patients with significant heart valve diseases who may benefit from early echocardiography? researchers will compare the rate of moderate or severe vhd detection between the experimental group and the control group to see if ai-ecg improve the detection rate of significant vhds. participants will: * be classified as high- or low-risk for vhd using an ai-ecg system * in the experimental group, high-risk participants will receive echocardiography based on ai-ecg results * in the control group, usual clinical care will be provided without routine echocardiography for ai-ecg high-risk results.


Eligibility criteria:
inclusion criteria: * at least one 12-lead ecg within 1 year * age 60-85 years of age exclusion criteria: * documented echocardiography within 3 years before indexed ecg * any known valvular heart disease * history of any valvular surgery * post-heart transplant
lesion dosimetry with 124-iodine in metastatic thyroid carcinoma

Conditions: Thyroid Cancer

Summary: one of the most effective treatments for metastases from thyroid cancer is a form of radioactive iodine known as 131-i. for more than 50 years, 131-i has been used to find and destroy thyroid cancer cells that have spread to other parts of the body. in many cases this treatment destroys the metastatic cells. however, in some patients it does not appear to work completely. this study is designed to use a slightly different form of radioactive iodine (called 124-i) which can precisely predict the amount of radiation that each metastatic lesion will receive. 124-i was developed at memorial sloan-kettering in the 1950s and has been used here and at many other medical centers around the world for diagnostic studies. it has been found to be very safe and effective at finding metastatic lesions. the high resolution of newer pet scanners now allows us to carefully determine how much radiation each metastatic lesion will receive. if 124-i can accurately predict which patients will not respond to 131-i treatments we can then avoid exposing those patients to unnecessary radiation. for the rest of the patients we can custom tailor the 131-i dose to destroy the metastatic lesions.


Eligibility criteria:
inclusion criteria: * adult thyroid carcinoma patients who have had a total thyroidectomy, histology confirmed by an mskcc attending pathologist, and radioiodine remnant ablation. * adult thyroid carcinoma patients who have previously demonstrated radioiodine-avid metastases and are about to undergo thyrogen-assisted dosimetry at mskcc. * the patient and physician are planning to administer 131-i for therapy if persistent radioiodine-avid metastases are present. * men and women of all races, ethnicities, and religious backgrounds are eligible. * all subjects must have measurable disease, documented within the previous six months by ultrasonography (us), mri, or non-contrast ct scanning. exclusion criteria: * thyroid cancer patients who do not have metastases. * thyroid cancer patients who have not demonstrated that their metastases concentrate radioiodine. * patients who are under therapy for other active cancers. * anaplastic or medullary thyroid carcinoma. * age less than 18 years. * patient who have received a therapeutic dose of radioiodine within the preceding nine months will not be eligible. * patients who plan to withdraw from thyroid hormone prior to dosimetry. * patients who are pregnant.

Keywords: 124-iodine i-131 metaiodobenz sulf (mibg) thyroid parathyroid
impact of atelectasis on rvedp following orthotropic heart transplantation

Conditions: Heart Transplant Failure; Anesthesia

Summary: following orthoptopic heart transplantation (oht), children undergo surveillance cardiac catheterizations to assess for signs of rejection including muscle biopsy as well as pressure measurements to guide post transplant treatment regiments. these procedures are done under general anesthesia which promotes lung tissue collapse (atelectasis). what is not known is the effect of atelectasis on intracardiac pressures which are a critical area of monitoring post-transplant patients for rejection.

following orthoptopic heart transplantation (oht), children undergo surveillance cardiac catheterizations to assess for signs of rejection including muscle biopsy as well as pressure measurements. these procedures are done under general anesthesia which promotes lung tissue collapse (atelectasis). atalectaisis is known to alter intra-thoracic pressures and cardiac loading conditions. what is not known is the effect of atelectasis on intracardiac pressures which are a critical area of monitoring post-transplant patients for rejection. therefore, the aim of this study is to identify if atelectasis impacts the pressure measurements obtained during cardiac catheterization.

Eligibility criteria:
inclusion criteria: * patients having undergone orthotropic heart transplantation * patients requiring routine heart catheterization for post-transplant surveillance * general anesthesia exclusion criteria: * patient/parental refusal * patients with suspected or known acute rejection * known anti-rejection medication non-compliance * patients within 1 year following heart transplant * home oxygen requirement * previous lung surgery (e.g., lobectomy) other than biopsy * lung transplantation * known pulmonary fibrosis * known pulmonary hypertension (\>1/2 systemic) * sedation without the use of an airway device * active respiratory infection -inability to provide recruitment breaths \>25mmhg -cardiomegaly * recipient/donor size mismatch
a new therapeutic approach for root coverage

Conditions: Gingival Recession

Summary: different surgical techniques have been proposed for root coverage, showing varying results especially in areas of deep recessions. the aim of this study is to evaluate the effectiveness of the newly forming bone technique (nfb)as an alternative treatment for miller class i or ii deep recessions, requiring regeneration of lost periodontal tissues. sample should be comprised of patients aged 18-45 years, both genders, presenting at least one site with marginal tissue recession \>4mm. patients will be randomly assigned to either one of the groups, based on treatment technique: newly forming bone (nfb) or subepithelial connective tissue graft (sctg). clinical examinations will be performed by a single blinded examiner at baseline, 1, 3, 6 and 9 months after surgery. intra-group analysis will be performed by one way analysis of variance for repeated measures. inter-group analysis will be performed by unpaired t-test for each of evaluation periods.

both gender patients presenting miller class i or ii recession defects \>4mm were selected. patients were randomly assigned to treatment groups: newly forming bone graft (nfbg) or subepithelial connective tissue graft (sct). patients were treated in the period of february 2008 and march 2008 and monitored during 9 months.

Eligibility criteria:
inclusion criteria: * healthy adults with at least one tooth presenting marginal tissue recession equal to or greater than 4mm in depth and one edentulous area or tooth to be extracted. exclusion criteria: * smokers * pregnants * use of anti-convulsants, anti-hypertensives, cyclosporine or hormones * use of antibiotics for the last 6 months * patients under treatment for medical conditions or presenting systemic disorders that would impair treatment results (e.g.: uncontrolled diabetes mellitus)

Keywords: root coverage graft soft tissue periodontal regeneration
a study of s6g5t3 in the treatment of acne vulgaris

Conditions: Acne Vulgaris

Summary: to assess the efficacy of s6g5t-3 compared to its vehicle when applied once daily for 12 weeks in participants with acne vulgaris.

in this phase 3, multi-center, double-blind, randomized, vehicle-controlled, parallel-group pivotal study, participants will be admitted only after a written informed consent has been obtained and after all inclusion/exclusion criteria have been met. male and female participants at least 9 years of age with facial acne vulgaris will be eligible for enrollment for daily treatment with s6g5t-3 or its vehicle s6g5t-8, for 12 weeks.

Eligibility criteria:
inclusion criteria: 1. participant must sign an institutional review board (irb) approved written informed consent for this study. 2. male and female 9 years of age and older. 3. have 2 or fewer cysts or nodules. exclusion criteria: 1. more than 2 acne nodules or cysts (defined as an inflammatory lesion greater than or equal to 5 millimeter \[mm\] in diameter). 2. acne conglobata, acne fulminans and secondary acne (for example, chloracne, drug-induced acne). 3. history of blood dyscrasia (for example, leukemia, haemophilia, sickle cell anemia, multiple myeloma). 4. underlying disease that requires the use of interfering topical or systemic therapy. 5. other dermatological conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments such as, but not limited to, atopic dermatitis, perioral dermatitis, or rosacea.
a pilot study of efficacy and tolerability of levetiracetam monotherapy in subjects with childhood absence epilepsy

Conditions: Epilepsy; Childhood Absence Epilepsy; Seizures

Summary: childhood absence epilepsy (cae) is a form of generalized epilepsy syndrome. clinically these seizures are manifest with a sudden, brief (3-15 second) loss of awareness followed by a quick recovery to baseline. keppra (levetiracetam) is approved by the u.s. food and drug administration (fda) to treat partial seizures in adults. it is currently being studied in children with partial seizures. absence seizures can be difficult to detect clinically, therefore the response to therapy will be determined both by clinical observation and by 24 hour eeg recordings. the researchers hope that with this information they will learn how well it works for the treatment of childhood absence epilepsy and at what dose. this is an open-label, dose-ranging pilot study of levetiracetam in subjects with newly diagnosed childhood absence epilepsy. approximately 20 patients will be needed to study effectiveness and dose requirements. subjects must not be on any antiepileptic medication at the time of entry into the study. male and female subjects from the ages of 4 to 10 years of age may participate.

this is a 12 week ( 12 week treatment phase), dose ranging pilot study on the effectiveness of levetiracetam for the treatment of childhood absence epilepsy. it consists of 1 phase. the treatment phase where the optimal medication dose will be defined. absence seizures are often brief and subtle with no postictal manifestations. as a result, clinical observation alone is inadequate to assess the seizure therefore, both subjective clinical response (parental/caregiver assessment) and eeg recordings are an important part of evaluation of treatment response. a 6 hour outpatient video-eeg study (including 3 minutes of hyperventilation), followed by an 18 hour ambulatory eeg recording - for total 24 hour eeg recording will be done before treatment and every 2 weeks after each dose plateau is reached )

Eligibility criteria:
inclusion criteria: * cae by eeg criteria * naive to antiepileptics * onset 3 to 10 years old * a history of daily seizures * age between 4 and 10 * weight at least 5th percentile for age * be able to take oral medications * be willing to return for diagnostic testing and visits and adhere to medication regime exclusion criteria: * an eeg with any of the following abnormalities * focal epilepsy * slow spike and wave discharges * photoconvulsive response * slow background rhythms for age * currently being treated with an antiepileptic drug (aed) * history of mr * a history of myoclonic, atonic,tonic or astatic seizures * a clinically unstable disease

Keywords: keppra epilepsy childhood absence epilepsy seizures
remote ischemic preconditioning as a new method of nephroprotection

Conditions: Acute Kidney Injury

Summary: remote ischemic preconditioning (ripc), elicited by brief episodes of ischemia and reperfusion in distant tissue, offers a protection against acute kidney injury (aki) in patients after cardiac surgery. investigators conducted a prospective, randomized, controlled clinical trial to assess whether ripc reduces the incidence of aki measured by standard way using serum creatinine concentration (scr) and with use of serum level of neutrophil gelatinase-associated lipocalin (ngal) as a new potential biomarker of a kidney injury. moreover the aim of investigation was to analyse the safety and clinical outcomes of ripc after elective, isolated, primary off-pump coronary artery bypass graft surgery (opcab).

cardiac surgery patients have a high risk of aki. the development of aki is associated with higher mortality and a higher risk for complications in patients undergoing cardiac surgery. however, there are no effective clinical strategies for preventing prevalence of aki. ripc as a simple, inexpensive way of protecting tissues against ischemic damage, may also reduce kidney injury. that makes ripc under the area of interests of many researches which apply this method to prevent aki. investigators conducted a single-center, double-blind trial involving patients at high risk of postoperative aki, in which want to check wether ripc reduce the prevalence of aki, according kidney disease: improving global outcomes (kdigo) definition, by increase in scr. furthermore researchers want to investigate a benefit from ripc in reduction of level of scr and higher glomerular filtration rate (gfr) 72 hours after off-pump coronary artery bypass as well as reduction of postoperative expression of ngal an early biomarker of aki.

Eligibility criteria:
inclusion criteria: * human patients with coronary artery disease. exclusion criteria: * history of cardiac surgery, * acute myocardial infarction up to 7 days before surgery, * chronic kidney disease in 4th or 5th stadium (egfr\<30 ml/min/1,73m2), * peripheral vascular disease affecting upper limbs, * history of severe injuries and surgeries in 2 months before cardiac surgery, * history of cancer, acute inflammation during hospitalization, * chronic autoimmunology diseases, * dialysis patients.

Keywords: remote ischemic preconditioning cardiac surgery-associated acute kidney injury neutrophil gelatinase-associated lipocalin
effectiveness of relaxation and massage methods in proximal femur fractures

Conditions: Fracture of Femur

Summary: the study will be conducted with volunteer patients who are followed up by the orthopedics and traumatology service of muğla sıtkı koçman university training and research hospital and who have undergone proximal femur fracture surgery and meet the study criteria. it is aimed to investigate the mid-term efficacy of relaxation exercises and classical massage of the sole of the foot applied in addition to the conventional physiotherapy program in the postoperative in-hospital period in patients with proximal femur fracture.


Eligibility criteria:
inclusion criteria: * male and female patients aged 50 years and older who were diagnosed with proximal femur fracture and underwent surgery * no medical contraindications that would limit the ability to exercise * having a caregiver who can supervise the exercise program after discharge * to be able to understand simple commands and to have signed the consent form exclusion criteria: * patients with pathological fractures and/or multiple fractures * those with serious early complications * terminally ill patients * circumstances that would interfere with conducting assessments or communicating * lack of cooperation during the study * scoring ≤14 on the mini mental state examinatio
analysis of letrozole in patients with operable hormone receptor positive, her2 negative breast cancer

Conditions: Breast Adenocarcinoma; Invasive Breast Carcinoma; Resectable Breast Carcinoma

Summary: the purpose of this study is to study to collect tissue samples from patients with early stage hormone receptor-positive her2-negative breast cancer.


Eligibility criteria:
inclusion criteria: * postmenopausal and suitable to receive aromatase inhibitor as per physician's discretion * histologically confirmed un-resected operable invasive adenocarcinoma of the breast ≥ 0.5 cm with estrogen receptor (er) and/or progesterone receptor (pr) positive ≥ 10%, and no human epidermal growth factor receptor 2 (her2) amplification or overexpression * patients must not have received any prior chemotherapy, radiation therapy, or endocrine therapy for their current breast cancer. patients who received tamoxifen or raloxifene or another agent for prevention of breast cancer may be included * willing and able to provide research tissue samples * willing and able to provide research blood samples exclusion criteria: * immunocompromised patients including patients known to be human immunodeficiency virus (hiv) positive or those on chronic steroids * note: must be off systemic steroids at least 14 days prior to pre-registration. however, topical steroids, inhalants or steroid eye drops are permitted * known history of active autoimmune disease that has required systemic treatment within =\< 30 days (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) prior to pre-registration * note: replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. patients with vitiligo, graves disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. patients with celiac disease controlled with diet modification are not excluded
restorative exercise for strength training and operational resilience (restore) for chronic or recurrent low back pain

Conditions: Lower Back Pain

Summary: the purpose of the study is to learn about the effect of integrative therapies on chronic or recurrent low back pain. the intervention called restore (restorative exercises for strength training and operational resilience) is based on a series of gentle stretching and strengthening exercises incorporating breath-work and mindfulness. the study is designed to discover the impact of restore on pain levels, physical function, and behavioral health.


Eligibility criteria:
inclusion criteria: * patients diagnosed with lower back pain with a pain score of 4 or higher on dvprs for 3 months * male or female * age 18-68\* * able to read and understand english * understands language, and able to report current pain levels and recall events * deers-eligible, military healthcare beneficiary exclusion criteria: * provider has advised against mild to moderate exercise * patient unable to sit on the floor for two minutes or unable to stand independently * complex regional pain syndrome, fibromyalgia, chronic fatigue syndrome, auto immune disease-related pain, other chronic medical conditions (i.e. advanced diabetic neuropathies) that preclude consent * patients with severe tbi * practiced yoga within 6 months * pre-surgical candidates for back surgery within 3 months * back surgery within the past year * pregnancy\*\*; females will be asked to self-report * undergoing medical evaluation board to determine discharge
establishing the benefits of adherence to enlarged prostate treatment: a validation study linking adherence to outcomes using the market scan database

Conditions: Prostatic Hyperplasia

Summary: adherence and length of therapy with 5-alpha reductase inhibitor (5ari) treatment may be associated with improved clinical outcomes of enlarged prostate (ep) as well as lower health care costs. the objective of this retrospective database analysis is to quantify the relationship between adherence and length of therapy with a 5ari and the likelihood of acute urinary retention (aur) or prostate surgery (emergency and non-emergency) in patients with benign prostatic hyperplasia (bph). the study will also measure the economic impact associated with these medical encounters. the marketscan database contains data from people with commercial health insurance and medicare and includes both medical and pharmacy data that are sourced directly from health plans and employers. approximately 18 million covered lives will be utilized for this study in the time period from january 1, 2003 to september 30, 2009. this study is a retrospective cohort analysis of medical claims data.


Eligibility criteria:
inclusion criteria: * male * aged 50 years or older * a diagnostic claim of benign prostatic hyperplasia (international classification of diseases, ninth revision, clinical modification \[icd-9-cm\] codes 222.2x or 600.xx) * a prescription claim for a 5-alpha reductase inhibitor (5ari) for at least 60 days during the observation period * continuous health plan eligibilitiy for 6 months prior to and at least 150 days after the initial 5ari prescription exclusion criteria: * a diagnosis of prostate cancer (icd-9-cm codes 185.xx, 198.82, 233.4, 236.5, 239.5, v10.46) * a diagnosis of bladder cancer (icd-9-cm codes 188.xx, 198.1, 223.3, 233.7, 239.4, v10.51), * a procedure code for any prostate-related surgery prior to the index date or 150 days after the index date * a diagnosis code for acute urinary retention (aur) prior to the index date or 150 days after the index date

Keywords: benign prostatic hyperplasia adherence acute urinary retention enlarged prostate 5-alpha reductase inhibitor surgery cost and cost analysis