Kornimate/medical-research-clean huggingface dataset:
post market study of single incision sling versus transobturator sling for stress urinary incontinence

Conditions: Stress Urinary Incontinence

Summary: the purpose of this research study is to compare the treatment device (solyx) to a different mesh sling or control device (obtryx ii) for the treatment of symptoms for stress urinary incontinence (sui). safety information and patient outcomes will be collected for three (3) years and evaluated.


Eligibility criteria:
inclusion criteria: 1. female ≥ 18 years of age 2. willing and able to comply with the study procedures and provide written informed consent to participate in the study (subject or legal representative) 3. diagnosed with predominant sui confirmed by positive cough stress test during the protocol required bladder fill procedure (see manual of operations) 4. confirmed sui is greater than urge incontinence with the medical epidemiologic social aspect (mesa) questionnaire 5. cystometric capacity ≥ 300 cc 6. post-void residual (pvr) of ≤ 150 cc 7. medically approved for general, regional or monitored anesthesia exclusion criteria: 1. subjects who are pregnant, lactating, or planning future pregnancies 2. subjects with a chief complaint of overactive bladder 3. subjects with a pattern of recurrent urinary tract infections, defined as ≥ 2 culture-proven urinary tract infections during a 6-month period prior to surgery or ≥ 3 in a 12-month period 4. subjects with previous surgical procedures for sui including bulking, urethral sling, bone anchor, burch procedure, pubo-vaginal sling, and marshall-marchetti-krantz (mmk) procedure. excluding kelly plication, botox, anterior repair, or inter-stim 5. subjects with prior pelvic organ prolapse surgery who experienced mesh complications 6. subjects with previous radiation therapy to the pelvis 7. subjects with known or suspected hypersensitivity to polypropylene mesh 8. subjects with any of the following confounding conditions: 1. neurogenic bladder 2. urethral stricture and bladder neck contracture 3. bladder stones or tumors 4. urinary tract fistula or diverticula 5. pathology which would compromise implant placement including subjects currently taking anticoagulation therapy 6. pathology that would limit blood supply or infections that would compromise healing including chemotherapy, systemic steroids and systemic immunosuppressants 9. subjects with diabetes and an a1c ≥ 7% 10. non-english speaking subjects 11. subjects who have participated in an investigational study (medical device or drug) within 30 days of study entry that may impact analysis of this device or have previously participated in the current study
project icare: intervening for community awareness, respect, & empowerment

Conditions: HIV Infections

Summary: this project will test the efficacy of a behavioral intervention to reduce sexual risk for hiv infection among african american men who have sex with men (msm).


Eligibility criteria:
inclusion criteria: * be 18 years of age or older; * self-identify as african american * understand and read english; * live within the chicago area; * report at least two (male or female) sex partners in the past three months, and unprotected anal sex with at least one male sex partner in the past three months. exclusion criteria: * have been diagnosed with hiv within the past three months (to allow for psychological and behavioral adjustment following an initial hiv diagnosis); * have a specific plan to move from the chicago area within the next nine months; * report active injection drug use other than hormones or steroids. * participated in the intervention video or the pilot phase of this study.

Keywords: hiv unsafe sex high risk sex hiv prevention african-american gay bisexual intervention trial
breath training exercise for the reduction of chronic dyspnea

Conditions: Chronic Pulmonary Disorder

Summary: the purpose of this study is to test whether a breath training exercise program may be used to make patients with chronic lung conditions feel less short of breath, whether such a program is well received by patients and whether a future larger study is worthwhile. the breath training exercise program uses some breathing techniques derived from yoga practices. they were shown to help patients experiencing shortness of breath feel less short of breath in other settings. whether the training is beneficial to patients with chronic lung conditions, especially those with a history of cancer affecting their lungs, is not clear. this study would help us answer that question.


Eligibility criteria:
inclusion criteria: * \>18 years of age * diagnosis of a chronic pulmonary disorder (a diagnosis of lung cancer is not required as the symptom of dyspnea, not cancer itself, is targeted) * if diagnosed with lung cancer, must have completed definitive treatment more than 6 months prior * at least moderate dyspnea defined by a bdi score of 6 or less in the self- administered computerized versions of the baseline and transition dyspnea indexes(sac-bdi/tdi)13,14 (this cutoff score is close to the score of 5.7 used to define "moderate dyspnea" in the publication that validated the instrument and is selected by attending physicians in the pulmonary service as a good indication of "moderate dyspnea" in clinical practice. a typical person with bdi of 6, for example, would be a 52 year old woman who has to pause when walking because of dyspnea and/or has eliminated doing an activity because of dyspnea). * able to safely complete the six minute walk test (6mwt)15 as per attending physician's clinical judgment. * respiratory functions clinically stable for the preceding 3 months and expected to be stable for the next 3 months as determined by project pis and other pulmonary medicine faculty. exclusion criteria: * life expectancy less than 6 months * any cause of dyspnea that is determined by the investigators as readily reversible by other means (e.g. pleural effusion, pulmonary embolism, acute infection, anemia hb\<9.0, etc.) * non-english speaking

Keywords: dyspnea breath training exercise 12-261
attention deficit hyperactivity disorder (adhd) prediction of treatment response

Conditions: Attention Deficit Hyperactivity Disorder

Summary: this is a 6-month trial in adults to find out if certain neuromarkers can predict individual treatment response to stimulant medications for attention deficit hyperactivity disorder (adhd). males and females, ages 18-45, will complete an mri scan at mit prior to beginning medication for adhd as determined by a treating clinician outside the context of this study.


Eligibility criteria:
inclusion criteria: * male and female adults ages 18-55 * a diagnosis of dsm-v adhd based on clinical assessment supported by the adhd module of a structured diagnostic interview * proficiency in english * right-handed exclusion criteria: * any contraindication for the use of a stimulant medication * investigator and his/her immediate family (spouse, parent, child, grandparent, or grandchild) * any contraindications for mri examination (metallic implants, such as pacemakers, surgical aneurysm clips, or known metal fragments in the body) * women who are currently pregnant or breastfeeding, as confirmed by a urine pregnancy test * clinically significant abnormal baseline laboratory values, including systolic and diastolic blood pressure parameters above 140 and 90, respectively and resting heart rate outside 60-100 bpm

Keywords: adhd methylphenidate amphetamine attention deficit hyperactivity disorder treatment
performance of coronary ct angiography to rule out coronary artery disease after out-of-hospital cardiac arrest

Conditions: Out of Hospital Cardiac Arrest Without ST-segment Elevation

Summary: out-of-hospital cardiac arrest (ohca) has multiple etiologies. in the absence of st-elevation myocardial infarction, percutaneous coronary intervention (pci) is delayed. this study aims to determine the diagnostic accuracy of coronary calcium score (ccs) and coronary ct angiogram (ccta) to rule out a coronary artery disease (cad) in the first days after an ohca.

each year, 50.000 out-of-hospital cardiac arrest (ohca) occur in france. acute myocardial infarction (ami) is one of the most frequent etiology of ohca. when a cardiac arrest is due to a st-elevation myocardial infarction (stemi), a percutaneous coronary intervention (pci) is realized in emergency. however, without st-elevation, pci timing is unclear. 2020 european society recommandations suggest that pci should not be realized in emergency, based on lemkes and al. clinical trial. but there is scarce evidence about the exact timing to realize pci. electrocardiogram, troponin level, and echocardiography are unprecise to rule-out an ischemic etiology of cardiac arrest. a brain ct-scan and a ct-pulmonary angiogram are recommended in first place, to identify the etiology of the cardiac arrest if there is no st-elevation nor obvious causes. nevertheless, in the absence of scanographic abnormality, a differed coronary angiogram should be realized. we suggest that coronary ct angiogram (ccta) and coronary calcium score (ccs) are feasible in the first days of hospitalization, and could rule-out a coronary artery disease (cad). the aim of the study is to avoid an invasive coronary exploration, and to have a quick answer about anti-thrombotic treatments management.

Eligibility criteria:
inclusion criteria : * patients hospitalized in intensive care unit after a resuscitated out-of-hospital cardiac arrest * no obvious cause for sudden death on anamnestic information, ct brain and ct pulmonary angiogram. * absence of st elevation myocardial infarction non-inclusion criteria : * in-hospital cardiac arrest * refractory cardiac arrest * indication of immediate coronary angiography * st-elevation myocardial infarction or unknown left bundle branch block * dynamic or presumably new contiguous st/t-segment changes * cardiogenic shock * life-threatening arrhythmias * coronary artery bypass graft * pregnancy * multiple organ failure syndrome * know severe chronic kidney disease (gfr \<30ml/min/1,73m²) exclusion criteria : * during the coronary computerized tomographic angiogram : * haemodynamic instability requiring high dose of vasopressors (\>1µg/kg/min of norepinephrine) * non sinusal cardiac rhythm * kdigo 1 acute kidney injury

Keywords: cardiac arrest diagnostic accuracy coronary computarized tomography angiogram coronary calcium score non-st elevated myocardial infarction
safety study of alfalastin (human alpha-1 antitrypsin) administered at home

Conditions: Alpha 1-Antitrypsin Deficiency

Summary: the purpose of this study is to collect safety data on alfalastin® infusions performed at home or in out-of hospital locations.

non interventional, observational, longitudinal, prospective, multicenter, non comparative study.

Eligibility criteria:
participation criteria: * patients above 18 y.o, * suffering from severe forms of primary alpha-1 antitrypsin deficiency, phenotype pizz or pisz with pulmonary emphysema, * currently treated as per routine practice, once a week, by alfalastin® at home or in out-of-hospital location * and having signed informed consent.

Keywords: alpha-1 antitrypsin deficiency alfalastin safety
mendd tolerance assessment study

Conditions: Short Bowel Syndrome

Summary: this study will utilize approved devices in an off-label manner to create forces required to induce intestinal lengthening. radial and longitudinal forces are both required, and two devices will be used to create forces in order to test tolerability of said forces. this is to provide evidence that humans could tolerate the forces produced by a proposed commercially built device. this study will test the hypothesis that radial and longitudinal forces necessary to produce enterogenesis will cause low levels of discomfort in healthy adults. approved devices will be utilized in an off-label manner to reproduce forces similar to our novel medical device which is designed to treat short bowel syndrome (sbs). this trial will not be testing a treatment for sbs, and individuals with sbs are ineligible for recruitment.


Eligibility criteria:
inclusion criteria: * existing ileostomy older than 6 weeks undergoing any existing procedure in endoscopy suite or operating room. exclusion criteria: * inflammatory bowel disease of small bowel pregnant short bowel syndrome bleeding disorder chronic pain disorder individuals taking chronic pain medications including prescriptions, cannabinoids or over the counter. individuals taking pain medications at the time of the procedure cognitive impairment to the extent that the questionnaire cannot be completed
the anti-oxidant effects of n-acetylcysteine in chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: chronic obstructive pulmonary disease (copd) is a condition defined as a disease state characterized by airflow limitation that is not fully reversible. the airflow limitation is usually progressive and is associated with an abnormal inflammatory response of lungs to noxious particles or gases, primarily caused by cigarette smoking. the accelerated decline in lung function is closely associated with an increased number of neutrophils in the sputum and hence with higher level of airway inflammation. it becomes clear that the inflammatory process potentiates as copd progresses and exerts damage which is irreversible. oxidative stress is inextricably linked to the inflammatory response. there is increasing evidence that an oxidant/antioxidant imbalance, in favor of oxidants, occurs in copd. nac has been reported to reduce the viscosity of sputum in both cystic fibrosis and copd, facilitating the removal of pulmonary secretions. moreover, by maintaining the airway clearance, it prevents bacterial stimulation of mucin production and hence mucus hypersecretion. the superiority of nac over the other mucolytics may be in its anti-inflammatory and antioxidant properties and its mucolytic actions. the aim of this study is to evaluate the effects of treatment with nac long on oxidative stress marker change and also explore the effect of nac to airway inflammatory, lung function test and cat scores. selected oxidative stress marker was defined as 8 - isoprostane, protein carbonyl, dna damage.


Eligibility criteria:
inclusion criteria: * eligible stable copd patients who are currently treated with only short-acting bronchodilator (salbutamol or fenoterol/ipratropium bromide) or long-acting bronchodilator (laba or lama) or inhaled corticosteroids/laba * pre-bronchodilator fev1 ≥ 80% and \< 80% predicted * current or ex-smokers (≥ 10 pack year) exclusion criteria: * concomitant with active and old pulmonary tb, lung cancer, bronchiectasis, lung fibrosis, destroyed lung and other malignancies * recent acute coronary syndrome (within 12 weeks) * cerebrovascular disease without neurological recovery * cognitive impairment * recent acute exacerbation of copd (within 4 weeks) * recent respiratory viral infection (within 4 weeks) * could not provide adequate sputum specimens * develop worsening of copd symptoms during sputum induction * could not provide informed consent
botulinum toxin injection prevent paroxysmal atrial fibrillation

Conditions: Paroxysmal Atrial Fibrillation

Summary: the aim of this prospective non-randomized study was to assess the efficacy and safety of endomyocardial botulinum toxin injection in projections of main ganglionated plexuses of left atrium for preventing drug-resistant paroxysmal atrial fibrillation.


Eligibility criteria:
inclusion criteria: * drug-resistant paf exclusion criteria: * previous heart surgery and af ablation procedure * emergency cabg * unstable angina or heart failure * persistent af, af at the time of screening (planned maze procedure or pulmonary vein isolation) * use of i or iii antiarrhythmic drugs within 5 elimination half-lives of the drug (or within 2 months for amiodarone) * requiring concomitant valve surgery * left ventricle ejection fraction \<35% * left atrial diameter \>55 mm * unwillingness to participate
interest of maintenance chemotherapy after induction treatment for inflammatory breast cancer

Conditions: Inflammatory Breast Cancer

Summary: to evaluate the benefit of adding docetaxel-5 fluorouracile (d-5fu) regimen after pre-operative epirubicin-cyclophosphamide (ec) and loco-regional treatment in inflammatory breast cancer (ibc).


Eligibility criteria:
inclusion criteria: * histologically proven breast cancer * inflammatory breast cancer * no metastatic site * age \> or = 18 and \< or = 60 * oms score: 0, 1, 2 * life expectancy \> or = 3 months * normal (isotopic or ultrasonography) left ventricular ejection fraction * normal haematological, liver, and kidney functions * patients who gave their written informed consent. exclusion criteria: * non inflammatory breast tumour with a cutaneous permeation nodule * presence of a metastatic site * medical history of a cancerous tumour except for carcinoma in situ of the uterine cervix, a basal cell skin cancer, or a breast carcinoma on the contralateral side * patients having already had a chemotherapy, a radiotherapy, or an hormone therapy for this breast tumour * medical history of congestive heart failure even medically controlled * medical history of myocardial infarction during the 6 months before the inclusion in the study * active infection or other severe underlying pathology which could possibly prevent the patient from receiving treatments * administration of another chemotherapy during the study * pregnant or breast feeding patients (the patients of childbearing age must be placed under efficient contraception) * patients whose social or psychological state does not allow to consider a correct adherence to the treatment and to the required medical follow-up * who score 3,4 * unbalanced diabetes * polysorbate 80 allergy
a study of pertuzumab in combination with herceptin in patients with her2 positive breast cancer.

Conditions: Breast Cancer

Summary: this 4 arm study will evaluate the efficacy and safety of 4 neoadjuvant treatment regimens in female patients with locally advanced, inflammatory or early stage her2 positive breast cancer. before surgery, patients will be randomized to one of 4 treatment arms, to receive 4 cycles of a)herceptin + docetaxel b)herceptin + docetaxel + pertuzumab c)herceptin + pertuzumab or 4)pertuzumab + docetaxel. pertuzumab will be administered at a loading dose of 840mg iv, then 420mg iv 3-weekly, herceptin at a loading dose of 8mg/kg iv then 6mg/kg 3-weekly, and docetaxel at a dose of 75mg/m2 escalating to 100mg/m2 3-weekly. during the entire pre- and post-surgery period all patients will receive adequate chemotherapy as per standard of care, as well as any surgery and/or radiotherapy as required. the anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * female patients, \>=18 years of age; * locally advanced, inflammatory or early stage invasive breast cancer; * her2 positive (her2+++ by ihc or fish/cish+). exclusion criteria: * metastatic disease (stage iv) or bilateral breast cancer; * previous anticancer therapy or radiotherapy for any malignancy; * other malignancy, other than cancer in situ of the cervix, or basal cell cancer; * insulin-dependent diabetes; * clinically relevant cardiovascular disease.
continuous delivery of levodopa in patients with advanced idiopathic parkinsons disease - cost-benefit

Conditions: Parkinson Disease

Summary: an open, observational health economic study to estimate marginal cost and health consequences of replacing conventional parkinsons disease therapy with intraduodenal levodopa administered continuously


Eligibility criteria:
inclusion criteria: * clinical diagnosis of of idiopathic parkinsons disease * motor fluctuations despite optimised per oral treatment exclusion criteria: * severe dementia, confusion, psychosis or depression * patients with contraindications against levodopa treatment
comparing the antibacterial effect of 810 nm diode laser and photodynamic therapy

Conditions: Periradicular Disease

Summary: the aim of this study was to compare the antibacterial efficacy of diode laser 810nm and photodynamic therapy in reducing bacterial microflora in endodontic retreatment of teeth with periradicular lesion.

conventional techniques of root canal treatments such as mechanical instrumentation and chemical debridement with antimicrobial irrigants, such as sodium hypochlorite (naocl) and chlorhexidine and use of calcium hydroxide do not always suffice to predictably render root canals free of bacteria using the high-power diode laser is a new approach of disinfection allowing access to the previously unavailable areas, such as the tubular network. this study, therefore, compares two types of diode lasers (low-power and high power) in terms of anti-bacterial effect as well as the conventional endodontic retreatment to determine the ideal method of root canal disinfection.

Eligibility criteria:
inclusion criteria: - endodontic retreatment of teeth with periradicular lesion. exclusion criteria: -
osuwmc eei sequential cataract patient experience project

Conditions: Cataract Surgery Experience

Summary: the purpose is to gauge the patients' level of comfort and anxiety for sequential cataract surgeries to assess if the second experience of cataract surgery differs from the initial experience.

each patient is scheduled to undergo two sequential cataract extractions under topical anesthesia with local anesthetic eye drops and minimal sedation- one on each eye. the surgeon, basic surgical procedure, anesthetic technique, and approximate length of procedure are reasonably similar and the patients act as their own control. subjects in the study will answer very brief questions regarding anxiety and comfort about their surgery before and after each procedure, and on the day after their second surgery.

Eligibility criteria:
inclusion criteria: 1. patients undergoing sequential cataract surgeries within a 6 week time period performed by the ophthalmologist, amit tandon, md. 2. aged 18 years and older. exclusion criteria: 1. cognitive impairment causing inability to participate in survey 2. language barrier causing an inability to participate in survey 3. healthcare poa or guardian leading to an inability to consent to survey 4. physician autonomy; patients that are inappropriate for the study as deemed by investigator