Kornimate/medical-research-clean huggingface dataset:
study of the efficacy and safety of lonidamine for the treatment of symptomatic benign prostatic hyperplasia

Conditions: Benign Prostatic Hyperplasia

Summary: the purpose of this trial is to evaluate the dose response relationship of lonidamine and the primary efficacy endpoint, international prostate symptom score (ipss), in subjects with symptomatic benign prostatic hyperplasia (bph).


Eligibility criteria:
inclusion criteria: 1. capable of understanding the purpose and risks of the study and sign a statement of informed consent 2. male 65-80 years of age (or 40-80 with vasectomy). vasectomized men must have documentation of azoospermia. 3. presence of luts (lower urinary tract symptoms) for at least 3 months 4. prostate volume measured by trus (transrectal ultrasound) \> 30 cc 5. qmax \< 15 ml/sec when measured by uroflowmetry (minimum of 125 ml must be voided) 6. ipss (international prostate symptom score) \> 12 7. psa \> 1.0 ng/ml 8. must ensure and consent to use medically acceptable methods of contraception throughout the entire study with sexual partners of childbearing potential 9. able to comply with the prescribed treatment protocol and evaluations exclusion criteria: 1. prior treatment for bph with alpha blockers and/or herbal supplements for the treatment of bph in the past 2 weeks (alpha-blockers and/or herbal supplements for the treatment of bph are not allowed during the study). prior treatment with 5-alpha reductase inhibitors is allowed if discontinued at least 3 months prior to enrollment. 2. prior surgery of the prostate (except biopsies; subject is eligible to enroll one month after full recovery from prostate biopsy.) 3. current or past evidence of malignant disease of the prostate or prostatic intraepithelial neoplasia (for subjects with psa between 4 - 10 ng/ml, prostate cancer must be ruled out to the satisfaction of the principal investigator. subjects with psa \>10 ng/ml are excluded). 4. active urinary tract infections (uti) 5. active cardiac, renal or hepatic disease as evidenced by: 1. serum creatinine \> 1.8 mg/dl 2. alt or ast \> 2.5x the upper limit of normal 3. history of active myocardial infarction, unstable cardiac arrhythmias, or stroke within 6 months prior to screening 4. uncontrolled congestive heart failure 6. uncontrolled diabetes mellitus (fasting blood glucose \> 200 mg/dl) 7. use of systemic steroids for any reason (systemic steroid usage is not allowed during the study). inhaled and/or topical steroids are allowed. 8. concurrent participation or participation in an investigational drug study within the past 30 days prior to screening 9. concomitant disease or condition that could interfere with the conduct of the study, or would in the opinion of the investigator, pose an unacceptable risk to the subject

Keywords: benign prostatic hyperplasia bph enlarged prostate
pilates method and/or photobiomodulation in women with stress urinary incontinence

Conditions: Laser Therapy; Urinary Incontinence,Stress; Pilates Method

Summary: the present study is a clinical intervention applied to patients with urinary incontinence, with the intention of verifying the effects of the pilates method associated or not with photobiomodulation with static magnetic field. the sample will consist of women with stress urinary incontinence from bento gonçalves attended at the school clinic of faculdade cenecista de bento gonçalves.


Eligibility criteria:
inclusion criteria: * women between 30 and 60 years old; * present a clinical diagnosis of sui; * the patient must be available at pre-scheduled times for a period of 12 weeks, with full participation; * the participant must agree with the methodology proposed by the project and, if so, must sign the tcle as legal proof of their participation. exclusion criteria: * patients with urge urinary incontinence; * constant flow urinary incontinence and stress urinary incontinence during the gestational period (because these are possible transitory cases due to pregnancy); * women who have difficulty in understanding; * patients who have more than one absence per month during the interventions.
efficacy and safety of asenapine compared with olanzapine in patients with persistent negative symptoms of schizophrenia (25543)(completed)(p05817)

Conditions: Schizophrenia

Summary: treatment with conventional antipsychotics such as haloperidol has little effect or may sometimes even worsen negative symptoms (such as blunted affect, emotional withdrawal, and poor rapport) of schizophrenia. the newer "atypical" antipsychotics agents, such as olanzapine, have shown improvement in the treatment of negative symptoms in acute trials. the purpose of this study is to compare an investigational compound (asenapine) with a marketed agent (olanzapine) in the treatment of stable subjects with persistent negative symptoms of schizophrenia for 6 months. patients completing this study may be eligible to participate in an extension 6 months of treatment. patients are required to have stable symptoms prior to entry into study.


Eligibility criteria:
inclusion criteria: * have a documented current diagnosis of schizophrenia of paranoid, disorganized, catatonic, residual, or undifferentiated subtype with persistent negative symptoms. * no increase in level of psychiatric care during the past few months due to worsening of symptoms of schizophrenia. * caregiver required. exclusion criteria: * have an uncontrolled, unstable clinically significant medical condition. * have any other psychiatric disorder other than schizophrenia as a primary diagnosis including depression.
propofolsleep - a study on cardiopulmonary and pharyngeal reactions while drug induced sleep endoscopy (dise)

Conditions: Sleep Apnea, Obstructive; Electroencephalography; Echocardiography; Blood Gas Monitoring, Transcutaneous; Consciousness Monitors

Summary: while drug induced sleep endoscopy (dise) in patients with obstructive sleep apnea syndrome (osas) apnea and hypopnea occur. because of the induced phases of apnea in a controlled setting it is possible to evaluate the related pathophysiology of apnea. we plan to correlate the patient state index (psi) and other physiologic parameters with phases of apnea and hypopnea.

dise is a standard method in diagnosis of osas and its specific localisation and severity. 20 patients with polysomnographic diagnosed osas will be enrolled in this prospective observational study. all patients would get a dise because of the before mentioned reasons (localisation and severity) although they wouldn't participate in this study. they will get a 24-h-rr (blood pressure)-measurement, a transthoracic echocardiography, a peak-flow-test and routine lab examination including troponin and probnp before the examination. furthermore they have to fill out the epworth sleepiness scale questionaire. before starting the dise a standard-monitoring (electrocardiography, pulse oximetry, non-invasive blood pressure, patient state index, near infrared spectroscopy, transcutaneous co2 (carbon dioxide), invasive blood pressure) will be established. after applying the monitoring the dise is started by target controlled infusion (marsh model) with a sighted goal-concentration of 3.0 µg/ml propofol in 5 minutes. while the examination a stabile snoring-phase with apnoea/hypopnoea is needed. in this moment a video-endoscopy is started to quantify the level of obstruction. after dise the sedation will end and the patients will be transported to the recovery room or postanesthesia care unit (pacu). for specific order of events a video recording of the dise will be realized.

Eligibility criteria:
inclusion criteria: * informed written consent * age of 18 years or older * no participation in other prospective interventional studies * osas with a polysomnographic shown ahi (apnea-hypopnea-index) of 15/h or more exclusion criteria: * no written informed consent * allergies against study medication * asa (american society of anesthesiologists) class 4 or higher * neurodegenerative cns (central nerve system) or muscle diseases * pregnant or breastfeeding patients * 25 % or more central or mixed apneas in polysomnography

Keywords: dise osas psi
environmental & genetic influences on vitamin d status

Conditions: Vitamin D Deficiency

Summary: the purpose of this study is to determine the effect of environmental and genetic influences on vitamin d status.

vitamin d deficiency is a common problem. the principal source of vitamin d for humans is solar exposure, with cutaneous synthesis of vitamin d by photoconversion of 7-dehydrocholesterol in the skin to pre-vitamin d3. latitude, altitude, season, skin pigmentation, and age are recognized factors that influence how much vitamin d can be made by solar exposure. surprisingly, vitamin d deficiency has been described in people dwelling in southern florida and in surfers in hawaii. we hypothesize that genetic variations in vitamin metabolism accounts for these differences.

Eligibility criteria:
inclusion criteria: * able to consent and come for a study visit. * male or female between ages 18-60. * sun exposure \>3 hours daily for at least 5 days weekly for the last 3 months. exclusion criteria: * unable to consent or come to a visit * taking vitamin d supplements, anticonvulsants, barbiturates, steroids, having granulomatous disease, or liver or kidney disease as these medications and conditions interfere with vitamin d metabolism. * related to another participant by blood.

Keywords: vitamin d deficiency sun genetics
peri-implant tissues in blx® implants

Conditions: Dental Implant Failed; Dental Prosthesis Failure

Summary: this is a randomized triple-blind clinical trial to evaluate the behavior of peri-implant tissues (bone and soft tissues) in blx implants loaded early or delayed and with different surgical milling protocols. to this end, 40 blx implants with a diameter of 3.75x10 will be placed in areas of mature bone scarred after extraction. they will be divided into 2 study groups, and these in turn into two subgroups. group a: complete milling, group b: partial milling. each group will be assigned with code 1: early load and code 2: deferred load. clinical and radiological parameters will be evaluated.


Eligibility criteria:
inclusion criteria: * patients without systemic pathology * adult of age who agree to be part of the study and sign the informed consent. * patients smoking less than 5 cigarettes / day, * patients not being completely edentulous * unitary / multiple absences in the area posterior with or without free ends to distal, maxillary or mandibular that do not require regenerative techniques * area of mature bone healed at least 6 months post-extraction. * the minimum torque for early loading will be 25 n. the placement of the implant will be mechanical up to 40 n maximum and manually finished with a surgical dynamometer. * the placement of the abutment will be at a minimum of 25 n, in case the primary stability of the implant allows it, it will be placed at 35 n. * the placement of the implant must always be 4 mm below the future gingival margi exclusion criteria: * immunosuppressed patients * aesthetic edentulous areas of 13-23 and 33-43 * smokers of more than 5 cigarettes * implants with a lower torque whose will be submerged with a screw and a protocol will be followed in 2 phases, being discarded from the study. * index of bleeding greater than 30% * patients with less than 2 mm of keratinized gingiva * implants with isq index \<55 * when a margin of 1 mm safety cannot be assumed to the inferior dental nerve

Keywords: dental implant immediate loading periimplant tissues
efficacy and safety of endoscopic ultrasound guided fine-needle injection of dendritic cells vaccination into unresectable pancreatic cancer

Conditions: Pancreatic Cancer

Summary: pancreatic cancer is the second most frequent gastrointestinal malignancy. the overall survival is dismal. especially for advanced pancreatic cancer, the conventional approaches are typically not curative and provide only minor increases in survivals in most cases. dendritic cells (dcs) are powerful antigen-presenting cells (apcs) that play a pivotal role in the initiation, programming, and regulation of tumor-specific immune responses. isolated dcs loaded with tumor antigen ex vivo and administered as a cellular vaccine have been found to induce protective and therapeutic anti-tumor immunity in experimental animals. some clinical trials of dc vaccination for cancer patients have shown the induction of anti-tumor immune responses and tumor regression. endoscopic ultrasound (eus) is an established technique for the diagnosis and staging of pancreatic cancer. endoscopic ultrasound guided fine-needle direct injection of dendritic cells vaccination into pancreatic tumors may be a promising treatment modality.therefore, the purpose of the study is to evaluate the efficacy and safety of endoscopic ultrasound guided fine-needle injection of dcs vaccination into advanced pancreatic cancer


Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed adenocarcinoma of the pancreas. 2. patients must be deemed unresectable due to involvement of important vasculature, adjacent organ invasion, presence of metastasis, or other medical condition making surgical resection unfavorable. 3. life expectancy of \>3 months. 4. karnofsky performance status \>50%. 5. patients must have adequate clotting and coagulation function (platelet \> 100k; inr\<1.4). 6. able and willing to sign a written informed consent. exclusion criteria: 1. patients receiving anticoagulation therapy. 2. steroids or immunosuppressing agent dependant status 3. patients who have received prior gemcitabine or radiation therapy in the past 4 weeks 4. ongoing infection 5. pregnancy or breast-feeder 6. other concurrent diseases including other malignancy,psychiatric illness,heart, lung and renal disfunctions 7. massive ascites 8. decision of unsuitableness by principal investigator or physician-in-charge

Keywords: endoscopic ultrasound-guided fine-needle injection dendritic cell vaccination
assessing pyridium for post-sling urinary retention

Conditions: Urinary Retention

Summary: there has been preliminary data showing that pyridium can decrease the risk of difficulty urinating after midurethral sling. this study is designed to have two groups of patients. one group will receive pyridium pre-operatively, while the other group will have routine preoperative care. both groups will have their bladder tested prior to going home. it will be evaluated if there is a difference in the difficulty to urinate post-operatively in both groups.

this is a prospective randomized controlled trial. it will have two arms with 48 patients in each arm, a total of 98 patients. patients will be randomized with a block randomization schedule generated by computerized random numbers using a 1:1 allocation to pyridium and routine perioperative care. the study is powered to see a difference in incidence of urinary retention after midurethral sling using 25% as the historic control for our institution. statistical sample size was based on a decrease in incidence to 5% in the pyridium arm. this is with 80% power and alpha 0.05. after the patient's surgery, including a midurethral sling, the patient will have an active voiding trial performed as described by pulvino et al. the patient's bladder will be backfilled with 300cc of sterile saline. if the patient cannot tolerate 300cc, the patient will be filled to maximum capacity. the patient will be allowed 20 minutes to void. the patient must void greater than two thirds the volume that was instilled in the bladder to consider it a passed voiding trial. the timing of the voiding trial will be at the discretion of the surgeon, accounting for factors such as complexity of concomitant surgery, the patient being alert, ambulating, with tolerable pain.

Eligibility criteria:
inclusion criteria: * any female patient undergoing a midurethral sling surgery, regardless of concomitant pelvic reconstructive or gynecological surgery exclusion criteria: * patients with complications from surgery requiring indwelling catheter, bladder/urethral perforation requiring indwelling catheter * acute bleeding requiring indwelling catheter for accurate urine output calculation * patients undergoing concomitant surgery other than gynecological, preoperative voiding dysfunction defined as postvoid residual \>150cc, or spinal anesthesia * women who are pregnant, including women of childbearing age who test positive on preoperative urine pregnancy test

Keywords: midurethral sling pyridium
a study to investigate intravenous tocilizumab in participants with moderate to severe covid-19 pneumonia

Conditions: COVID-19 Pneumonia

Summary: this study will assess the pharmacodynamics, pharmacokinetics, safety and efficacy of two different doses of tocilizumab (tcz) in combination with standard-of-care (soc) in hospitalized adult participants with moderate to severe covid-19 pneumonia.


Eligibility criteria:
inclusion criteria * hospitalization with covid-19 pneumonia confirmed by a positive polymerase chain reaction (pcr) of any specimen \[e.g., respiratory, blood, urine, stool, and other bodily fluids\]) and evidence of pneumonia on chest x-ray or computed tomography scan * for severe patients, spo2 \ 93%, but desaturation \</= to 93% on lower supplemental oxygen or ambient air is documented during screening, the inclusion criterion is met * for moderate patients (those who do not qualify as severe based oxygen requirements), crp \> 2 x upper limit of normal (uln) is required * for women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, as defined by the protocol * for men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm, as defined by the protocol exclusion criteria * known severe allergic reactions to tcz or other monoclonal antibodies * active tuberculosis (tb) infection * suspected active bacterial, fungal, viral, or other infection (besides sars-cov-2) * participants who are on a mechanical ventilator \> 24 hours or extracorporeal membrane oxygenation (ecmo), in shock, or combination thereof with other organ failure requiring treatment in an icu * in the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments * receipt of oral anti-rejection or immunomodulatory drugs (including tcz) within the past 3 months * alanine aminotransferase (alt) or aspartate aminotransferase (ast) \> 10 x uln detected within 24 hours at screening or at baseline (according to local laboratory reference ranges) * absolute neutrophil count (anc) \< 1000/ul at screening and baseline (according to local laboratory reference ranges) * platelet count \< 50,000/ul at screening and baseline (according to local laboratory reference ranges) * pregnancy or breastfeeding, or positive pregnancy test at a predose examination * treatment with an investigational drug within 5 drug-elimination half-lives or 30 days (whichever is longer) of randomization
physiological control for mechanical circulatory devices

Conditions: Heart Failure

Summary: aim of this clinical study is to compare our newly developed control algorithms for mechanical circulatory support devices based on physiological demand with the standard manual lvad speed operation. specifically it shall be demonstrated that: * suction is properly detected by the pre-trained pump flow estimation algorithm * suction events (due to changes in physiological demand) can be reduced by control algorithms compared to continuous speed * if suction is encountered, it can be detected and cleared * the pump reacts adequately to changes in patient demand due to physical activity * physicians pump setpoints (of requested speed for a certain heartrate) can be achieved safely.

patients complete a set of tests in constant speed setting and repeat the same tests with physiological control algorithms turned on. order is randomized.

Eligibility criteria:
inclusion criteria: all patients with a medtronic hvad system implanted at the medical university of vienna, division of cardiac surgery, which are able and willing to understand and sign the informed consent form, and which do not meet any exclusion criteria will be included. exclusion criteria: * inability to provide informed consent * patients with known intraventricular or aortic root thrombus formation confirmed by transthoracic ultrasound diagnostic * known pathology of the coagulatory system * supra or sub-therapeutic anticoagulation (aptt or inr) * suspected or confirmed pump thrombus (based on lab parameters, abnormal high pump power consumption or acoustic spectral analysis) * history of ischemic or hemorrhagic stroke (\<2 months) * hypertension at rest (mean arterial pressure \> 120mmhg) * cerebrovascular or musculoskeletal disease preventing the performance of daily life activities or exercise training * severe arrhythmia (e.g. long qt syndrome), ventricular fibrillation or required defibrillation - excluding the lvad implantation - in the previous 2 months * all contraindications applicable to the hvas are applicable to this study. the system is contraindicated: * in patients with a body surface area (bsa) less than 1.2 m² * in patients who cannot tolerate anticoagulation therapy * during pregnancy

Keywords: lvad physiological control
phase ii/iii study of anti-vegf in neovascular amd

Conditions: Macular Degeneration; Choroidal Neovascularization

Summary: the purpose of the study is to determine whether the anti-vegf drug is effective at stabilizing and/or improving vision in patients with the wet form of amd

this will be a randomized, double-masked, controlled, dose-ranging, multi-center comparative trial, in parallel groups. patients will be stratified by clinical center, by percentage of classic cnv vessels: \[predominantly classic (\>50%) vs. minimally classic (1-49%) vs. purely occult (0%)\], and according to whether, or not, they have received prior pdt with visudyne (no more than once). all patients will be re-randomized after 54 weeks of treatment to either, continue or discontinue therapy for further 48 weeks.

Eligibility criteria:
patients of either gender, aged 50 years or above, diagnosed with subfoveal cnv secondary to amd and with best corrected visual acuity of 20/40 to 20/320 in the absence of subfoveal atrophy or scarring in the study eye, and better or equal to 20/800 in the fellow eye, may be enrolled. clinically significant concomitant diseases will be excluded.

Keywords: choroidal neovascularization (cnv) subretinal neovascularization
helicobacter pylori eradication treatment in patients with duodenal ulcers

Conditions: Duodenal Ulcer

Summary: the study purpose is to evaluate helicobacter pylori susceptibility to clarithromycin and to estimate eradication and healing rates of duodenal ulcer routine eradication therapy at the end of treatment and 52 weeks from the therapy start


Eligibility criteria:
inclusion criteria: * active duodenal ulcer with duodenal ulcer exacerbation confirmed by endoscopic signs of duodenal ulcer disease (acute ulcer or scar deformity of the duodenal bulb) and anamnesis data. * helicobacter pylori positive diagnosis at entry by 13c-urea breath test (ubt) * prescription of the standard 7-day eradication therapy including esomeprazole 20 mg bd, amoxicillin 1000 mg bd, clarithromycin 500 mg bd * written informed consent provided prior the start of participation in the study. exclusion criteria: * subjects who are unwilling or unable to provide informed consent * current complication of duodenal ulcer disease, e.g. perforation, bleeding or pyloric stenosis * history of esophageal/gastric/duodenal surgery except of the patients underwent perforated ulcer closure or endoscopic hemostasis more than 6 months ago * contraindications to esomeprazole, amoxicillin or clarythromycin including known or suspected hypersensitivity or allergy * treatment with amoxicillin, clarythromycin or bismuth containing drugs one month prior to inclusion * two or more previous attempts to eradicate h. pylori

Keywords: helicobacter-positive duodenal ulcer