Kornimate/medical-research-clean huggingface dataset:
posterior tibial nerve stimulation vs. sham

Conditions: Overactive Bladder

Summary: the overall goal of this research is to determine the efficacy of a sham for posterior tibial nerve stimulation (ptns). this novel design is needed in order to have a sham treatment that is similar to the actual treatment. the ptns is used to treat urgency and frequency in people with overactive bladder (oab). until research is done using a sham component, we are unable to ascertain if the current use of ptns is due to a placebo effect.

subjects will be healthy volunteers who are recruited by word of mouth. at their office visit with the nurse practitioner (np), the subject's history and medication list will be reviewed. the np will randomize subjects into groups: one group with the ptns on the right and sham on the left; the other group with the ptns on the left and sham on the right. there will be a maximum of 30 subjects tested, and up to 50 people screened. the subjects will have 1 session for the testing of the ptns vs sham that will include 15 minutes of stimulation as noted below. all participants will be blinded to the therapy they receive as described below.

Eligibility criteria:
inclusion criteria: * male and female subjects \>18 years of age * female subjects will be menopausal, or have had a tubal ligation or hysterectomy. * capable of giving informed consent * capable and willing to follow study related procedures exclusion criteria: * pregnancy * interstim * bion * tens * the subject is deemed unsuitable for enrollment in this study by the investigators based on their history or physical examination (including bleeding disorders)

Keywords: overactive bladder posterior tibial nerve stimulation
direct assessment of microcirculation in shock (damis)

Conditions: Microcirculation; Intensive Care; Shock

Summary: maintaining organ perfusion is the key to successful intensive care medicine. shock is the most dangerous microcirculatory disorder and one of the most hazardous and lethal conditions of critically ill patients still showing high mortality rates. however, there are still ongoing controversies, how to assess microcirculation, how to predict outcome in time and how to guide specific therapy. macrocirculation does not reflect microcirculation. microcirculation reflects organ perfusion and correlates with the outcome. there is growing evidence that microcirculatory parameters are powerful tools to predict the outcome after cardiac arrest. several guidelines use it as a target to guide therapy, but these recommendations base only on supporting evidence of low quality. lactate is a late reflector of reduced organ perfusion and is of limited value for time-critical decision-making and their value as a therapeutic target. sublingual sidestream dark-field (sdf) - measurement is a non-invasive method that reliably reflects organ perfusion. the last generation of microcirculation assessment tools are easy to use hand-held devices that use an automatic algorithm. in consequence, microcirculation has become a directly detectable physiological compartment. however, systematic investigations about this technology in shock are still lacking. damis determines the value of directly assessed microcirculation on outcome in different types of shock. therefore, this multicenter study will recruit up to 200 patients in shock. after the first measurement, patients will be randomized either to intervention or to control. the intervention consists in knowing microcirculatory parameters. a checklist will assist the treating physicians of the interventional group in explaining microcirculatory values and offering possible treatment options. patients in the control group will be measured as well, but results will not be communicated to the treating physician.


Eligibility criteria:
inclusion criteria: 1. older than 18 years 2. admitted to the icu in state of shock at the time point of admission to icu or in the first 3 hours defined as * the need to use vasopressors, -dilatators, fluids to maintain mean arterial pressure \> 65 mmhg * and lactate \> 2 mmol/l exclusion criteria: 1. younger than 18 years 2. anatomic reasons that inhibit sublingual measurement 3. lack of informed consent 4. more than 4 hours after icu admission

Keywords: microcirculation intensive care critical care shock risk stratification sdf-measurement fluid resuscitation
two-arm study of a dna vaccine encoding prostatic acid phosphatase (pap) in patients with non-metastatic castrate-resistant prostate cancer

Conditions: Prostate Cancer

Summary: the investigators are trying to find new methods to treat prostate cancer. the approach is to try to enhance patients' own immune response against the cancer. in this study, the investigators will be testing the safety of a vaccine that may be able to help the body fight prostate cancer. the vaccine, called ptvg-hp, is a piece of dna genetic material that contains genetic code for a protein that is made by the prostate gland, called prostatic acid phosphatase (pap). the vaccine will be given together with a substance called an adjuvant. adjuvants are typically given with vaccines and can improve the effect of the vaccine. the adjuvant that will be used in this study is called granulocyte-macrophage colony-stimulating factor (gm-csf). the main purpose of this study is to find out whether the vaccine generates long-lived immune responses, and whether a better schedule of vaccination can be found by doing frequent laboratory testing for immune responses. the investigators also want to see if the vaccine stimulates any immune reaction against cancer cells.


Eligibility criteria:
inclusion criteria: * diagnosis of prostate cancer * castrate resistant disease with rising psa despite continuous treatment with orchiectomy or a lhrh agonist * rising psa after treatment and withdrawal of anti-androgen * serum testosterone \<50ng/ml * normal organ function per laboratory tests exclusion criteria: * no evidence of immunosuppression or on treatment with immunosuppressive agents * cannot have discontinued lhrh agonist treatment (if not previously treated by orchiectomy) within 6 months prior to study entry * must not be concurrently taking other medications or supplements with known hormonal effects (other than the lhrh agonist noted above). * cannot have any evidence for metastatic disease on bone or ct scan * unable or unwilling to undergo two leukapheresis procedure

Keywords: vaccine ptvg-hp prostate cancer castrate resistant
a study to monitor the health of participants in hivnet 014 who become infected with hiv-1

Conditions: HIV Infections

Summary: the purpose of this study is to evaluate the long-term consequences of hiv-1 infections that occurred in association with known, but discouraged, high-risk behaviors in persons who have received hiv candidate vaccines or placebo in hivnet 014. doctors need to look at how these patients respond to hiv infection in order to develop new hiv vaccines and other treatments for hiv and aids. patients who receive hiv vaccines are sometimes protected from hiv infection. more often, these patients become hiv-positive but experience a boost in their immune system that helps their bodies fight hiv. doctors need to look at how these patients respond to hiv infection in order to develop new hiv vaccines and other treatments for hiv and aids.

there are many possible outcomes of hiv-1 infection among persons who receive experimental hiv-1 vaccines. in the best-case scenario, these vaccines may prevent infection (sterilizing immunity). however, current viral vaccines are thought to limit, but not prevent, virus replication after infection. in the latter case, it is important to document the effect of the immune response on the disease course as reflected by viral load, the evolution of the viral quasi species, and clinical symptoms over time. understanding the evolution of the immune response in vaccinees after subsequent exposure and hiv infection will potentially result in valuable information for the subsequent design of preventive and therapeutic vaccines. this will be studied here using hivnet 014 participants at higher risk for hiv-1 infection. participants discontinue hivnet 014 vaccinations upon confirmation of hiv-1 infection and are enrolled in this study. participants undergo clinical and laboratory examinations every 3 months for the first year of follow-up and every 6 months for at least 4 years thereafter. additionally, hiv-infected partners of hivnet 014a participants undergo clinical and laboratory examination at enrollment, and may be asked to donate additional specimens at a later time. study endpoints include various virologic, immunologic, and clinical parameters, such as viral load, cellular immune response, and virus phenotype and genotype.

Eligibility criteria:
inclusion criteria patients may be eligible for this study if they: * become infected with hiv while participating in hivnet 014, or if they are an hiv-positive partner (sexual or needle-sharing) of a hivnet 014a participant. * are able and willing to provide written informed consent. exclusion criteria patients will not be eligible for this study if they: * have a serious psychiatric or psychological disorder that would prevent them from completing the study.

Keywords: placebos aids vaccines follow-up studies hiv therapeutic vaccine
the effect of preemptive analgesia on the comfort of patient and doctor, in cystoscopy

Conditions: Bladder Cancer; Benign Prostate Hyperplasia; Hematuria; Pain; Lower Urinary Tract Symptoms

Summary: the study was designed as a prospective, randomized double-blind placebo controlled trial. according to power analysis in regards of previous studies in the literature with diclofenac sodium, using a total of 144 patients are needed for power: 80% and efficacy: 0.05. diclofenac (20 mg) and placebo drugs to be used in the study will be numbered 1 and 2 individually. patient randomization was performed using random.org in 144 patients. on the day of cystoscopy, the patient randomized according to inclusion criteria will be given a medication package corresponding to the number given in randomization. it will not be known by the staff and cystoscopy will be performed by the physician who does not know which package is an effective drug. parameters: 1. visual pain score during cystoscopy 2. cystoscopy comfort - a questionnaire to be filled by the doctor 1. excellent 2. very good 3. good 4. bad 5. too bad 3. cystoscopy: is it efficient? not efficient? - will be answered by the doctor. post-op: 1. 1st hour visual analog pain scale inquiry, dysuria, frequency 2. 24th hour dysuria, frequency, a total of 144 patients, we plan to arrive at the end of 1 month.


Eligibility criteria:
inclusion criteria: * accepted to participate * 18-70 years old * men exclusion criteria: 1. previous peptic ulcer 2. gastro intestinal bleeding in advance 3. renal failure 4. liver failure 5. patients who underwent cystoscopy for taking or inserting double j stents 6 - drug allergies 7- patients under 18 8- patients receiving antiaggregant and antiplatelet therapy 9- patients who do not agree to participate in the study
feasibility study of the vessel restoration system (vrs) for the treatment of atherosclerotic lesions in the superficial femoral artery (sfa) and/or popliteal artery (pa) after sub-optimal percutaneous transluminal angioplasty (pta) or atherectomy: reactivate i

Conditions: PAD - Peripheral Arterial Disease

Summary: feasibility study of the vessel restoration system (vrs) for the treatment of atherosclerotic lesions in the superficial femoral artery (sfa) and/or popliteal artery (pa) after sub-optimal percutaneous transluminal angioplasty (pta) or atherectomy: reactivate i


Eligibility criteria:
inclusion criteria: subjects for this study must meet all of the following general eligibility criteria and the answer must be "yes" to all general inclusion criteria: 1. subject (or legal guardian) is willing and able to provide consent before any study-specific tests or procedures are performed and agree to attend all required follow-up visits. 2. male or female subject of at least 18 years of age. 3. chronic symptomatic lower limb ischemia defined as rutherford classification 2, 3, or 4. 4. has screen failed from the activate ii study due to the presence of grade c or d dissection(s). exclusion criteria: 1. life expectancy, documented in the investigator's opinion, of less than 1 year. 2. cerebrovascular accident (cva) or transient ischemic attack (tia) or cardiac event (e.g., pci for stemi/nstemi, unstable angina) within 6 months prior to the index procedure. 3. chronic renal insufficiency with serum creatinine ≥ 2.5 mg/dl or egfr \<45 ml/min within 30 days prior to the index procedure or treatment with peritoneal or hemodialysis. 4. subject has a platelet count \ 700,000 cells/mm3 within 30 days prior to the index procedure or has a history of bleeding diathesis. 5. receiving oral or intravenous immunosuppressive therapy. 6. subject has white blood cell (wbc) count \< 3.0 (3,000 cells/mm3) within 30 days prior to the index procedure. 7. history of major amputation in the target limb. 8. any major intervention planned at the index procedure or within 30 days post-index procedure including treatment of contralateral limb. 9. subject is pregnant, breastfeeding, or planning to become pregnant in the next 30 days. subjects (male and female) of childbearing potential must agree to use effective birth control measures for 30 days after the index procedure.
effectiveness and safety of viagra in men with ed and luts due to benign prostatic hyperplasia (bph)

Conditions: Impotence

Summary: the purpose of this study is to determine whether viagra is effective in treating erectile dysfunction and lower urinary tract symptoms in men affected by both conditions.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of erectile dysfunction (ed) * lower urinary tract symptoms (luts) exclusion criteria: * previous prostate surgery or invasive intervention for bph * active urinary tract disease
therapy of alzheimer's disease with neurofeedback

Conditions: Alzheimer Dementia (AD); Elderly

Summary: the project aims to investigate in patients of alzheimer's disease in a prodromal state (early state of the disease) compared to healthy subjects whether neurofeedback training with functional mri (fmri) can improve cognitive ability. it is of interest if voluntary modulation of brain activation with real-time (rt) fmri as a novel method affects cognitive ability, as well as functional and structural measures of the brain. over the course of the study subjects will learn a real-world footpath. during neurofeedback training subjects are then asked to recall this footpath while simultaneously trying to modulate their own brain activation based on feedback. feedback is given about the parahippocampal gyrus - a region of the brain associated with episodic and visuo-spatial memory, which is known to be affected early by alzheimer's disease pathology. before and after the training cognitive ability is assessed using neuropsychological tests mainly measuring numerous domains of memory. the investigators hypothesise that the training leads to an improvement of the trained cognitive domain, but also induces changes in brain structure and function.


Eligibility criteria:
inclusion criteria: * native speakers of german * naive to neurofeedback experiments * ability to provide written informed consent exclusion criteria: * metallic implants (mr-safety) * neurological/psychiatric disease (except alzheimer's disease in the patient group) * use of psychoactive medication (expect medication for alzheimer's disease) * familiarity with the study site

Keywords: neurofeedback real-time functional mri parahippocampus
thulep vs. holep vs. monopolar enucleation in management of bph

Conditions: Prostatic Hyperplasia, Benign; Prostate Adenoma; Lower Urinary Tract Symptoms

Summary: today, endoscopic enucleation of the prostate (eep) has been recognized a method of choice for treatment of benign prostatic hyperplasia (bph) of any size, including large-sized glands (\>80 cc). the goal of our study was to compare perioperative efficacy, functional outcomes and safety of different techniques of endoscopic enucleation of the prostate (monopolar enucleation, holmium laser enucleation, thulium laser enucleation) in a single center.

holep and thulep or eep have been approved by the current guidelines of the european association of urology for use in men with substantially enlarged prostates (\>80 ml) as first-line therapy \[1\]. this type of operation can be performed by means of several sources of energy. to our knowledge, there were no studies comparing efficacy and complications of these three treatment modalities. in this study the investigators have evaluated efficacy of thulium-fiber laser enucleation (120 w thulium fiber laser urolase, ipg ire-polus, russia with wavelength of 1940 nm) and monopolar enuclation in comparision with holep (versapulse powersuite 100, lumenis, usa/israel) in reduction of luts secondary to bph in a prospective randomized trial. all peri-operative parameters, urinary flow parameters, prostate size changes, erectile function and complications associated with the procedures were compared.

Eligibility criteria:
inclusion criteria: * ipss\>20; * maximum urinary flow rate\< 10ml\\s (qmax); * ineffective alfa-blockers therapy. exclusion criteria: * histologically verified prostate cancer; * history of prostatic surgery; * urethral strictures; * bladder stones; * chronic urinary retention and cystostomy.

Keywords: laser holep thulep thulium thulium-fiber bph eep monopolar enucleation
a follow-up study to examine the presence of anti-human growth hormone antibodies following a study (fe 999905 cs07) of zomacton in children with growth hormone deficiency

Conditions: Idiopathic Growth Hormone Deficiency

Summary: this is a follow-up study of patients, treated with one daily dose of zomacton or one daily dose of genotropin in the previously completed fe 999905 cs07 trial, who had presence of anti-hgh antibodies at any post-dosing visit during the 12-month treatment period. no investigational medicinal product will be administered in connection with this follow-up study. eligible patients will attend one visit in this follow-up study.


Eligibility criteria:
inclusion criteria: * previous participation in trial fe 999905 cs07 and presence of anti-hgh antibodies at any post-dosing visit throughout the 12-month treatment period * signed informed consent and obtained assent according to local rules and practice * information on medical history, concomitant medications, and growth hormone therapy since completion of trial fe 999905 cs07 exclusion criteria: * there are no pre-defined exclusion criteria in this study
a study of ustekinumab (stelara) in chinese participants with moderately to severely active crohn's disease

Conditions: Crohn Disease

Summary: the purpose of this study is to evaluate the clinical and endoscopic efficacy and safety of ustekinumab in chinese participants with moderately to severely active crohn's disease.


Eligibility criteria:
inclusion criteria: * have crohn's disease (cd) or fistulizing crohn's disease of at least 3 months duration, with colitis, ileitis, or ileocolitis, confirmed in the past by radiography, histology, and/or endoscopy * have moderately to severely active cd, defined as a baseline crohn's disease activity index (cdai) score of greater than or equal to (\>=) 220 and less than or equal to (\ 3, based on the unweighted cdai component of the number of liquid or very soft stools or b. mean daily abdominal pain (ap) score \>1, based on the unweighted cdai component of ap * have endoscopic evidence of active ileocolonic cd as assessed by central endoscopy reading at the screening endoscopy, defined as a screening simple endoscopic score for crohn's disease (ses-cd) score \>=6 (or \>=4 for participants with isolated ileal disease), based on the presence of ulceration in at least 1 of the 5 ileocolonic segments, resulting in the following specified ulceration component scores: a. a minimum score of 1 for the component of "size of ulcers"; and b. a minimum score of 1 for the component of "ulcerated surface" * a woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hcg\]) at screening and a negative urine pregnancy test at baseline * must sign an informed consent form (icf) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study exclusion criteria: * has complications of crohn's disease such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation that might be anticipated to require surgery, could preclude the use of the cdai to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with ustekinumab * has previously demonstrated lack of initial response (that is, primary nonresponders), responded initially but then lost response with continued therapy (that is, secondary nonresponders) to vedolizumab * has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, chronic renal infection, chronic chest infection (example, bronchiectasis), recurrent urinary tract infection (example, recurrent pyelonephritis or chronic non-remitting cystitis), or open, draining, or infected skin wounds or ulcers * history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly or monoclonal gammopathy of undetermined significance * has a history of severe, progressive, or uncontrolled renal, genitourinary, hepatic, hematologic, endocrine, cardiac, vascular, pulmonary, rheumatologic, neurologic, psychiatric, or metabolic disturbances, or signs and symptoms thereof