Kornimate/medical-research-clean huggingface dataset:
intra-operative assessment of cavernosal nerve stimulus threshold

Conditions: Prostatectomy

Summary: erectile dysfunction persists in approximately 80% of men 1 year after prostatectomy. various erectile rehabilitation strategies have not provided benefit. electrical stimulation has been demonstrated to benefit neuroregeneration and the functional recovery of neuromuscular systems. therefore, electrical stimulation of the cavernosal nerves during radical prostatectomy is being investigated for its potential development into a treatment aimed at improving recovery of erectile function after prostatectomy. this pilot study is intended to determine the threshold of electrical stimulation that results in penile erection, as defined by persistent intracavernosal pressure increase, such that future studies of sub-threshold stimulation may be pursued.

objective: to determine the cavernosal nerve electrical stimulation amplitude thresholds at which an erection, as indicated by persistent increases in intracavernosal pressure, occurs for various stimuli of fixed frequency and fixed pulse-width. study design: this is a prospective pilot study used to determine a threshold range of cavernosal nerve electrical stimulation parameters that result in penile erection. assignment to the order of stimulation paradigms will be randomized. no placebos are used. no blinding is used.

Eligibility criteria:
inclusion criteria: * subjects must have prostate cancer being treated via radical prostatectomy by a single surgeon (primary investigator) with planned intraoperative nerve sparing. * subjects must have intact preoperative erectile function, sufficient for penetrative intercourse without medication nor assistive device, as defined by a sexual health inventory for men (shim) / international index of erectile function (iief-2) score 22 or higher, which is collected as part of routine care. * subjects must have the ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * baseline erectile dysfunction, as defined by the use of medications or devices to assist erection, lack of baseline erections, or a shim / iief-2 21 or lower, which is collected as part of routine care. * lack of successful intraoperative nerve sparing. * neurologic, metabolic, or vascular diseases that may negatively impact erectile function, such as: diabetes mellitus, peripheral vascular disease, coronary artery disease, stroke, multiple sclerosis, parkinson's disease, multiple systems atrophy, epilepsy, or spinal cord injury. * inability to provide a fully informed consent.

Keywords: erectile disfunction urinary function
assessment of covid-19 in tearfilm

Conditions: Covid19; Ophthalmopathy; Eye Diseases

Summary: to assess the co-relation of covid-19 in nasopharyngeal swabs and tears or saliva, and to determine duration of covid-19 activity in ocular fluid and saliva by serial tests over 3 months.

patients who underwent covid-19 testing at vumc (vanderbilt university medical center) and had provided a written informed consent to be contacted in the future for covid related studies will be offered participation in this study. the covid- 19 has low prevalence in ocular fluids (5% of affected patients) but may survive for a long time or replicate in the conjunctiva, even in asymptomatic patients. patients with viral conjunctivitis are more likely to have covid-19 rna (ribonucleic acid) in tears. the use of schirmer's strips to collect tears for rna analysis of viruses has been previously validated. vumc is performing rna analysis on nasopharyngeal (np) swabs for covid-19 at several locations. several patients (test positive and test negative) have given consent to be contacted for future research purposes and are available in victr (vanderbilt institute for clinical and translational research) datamark and recovery databases. the positive tested patients will receive a schirmer's strip in the mail at their home to place in both eyes to test eye fluid and receive a tube for saliva while engaging in a zoom session for monitoring of the process. methodology: patients who underwent covid-19 testing at vumc and had provided a written informed consent to be contacted in the future for covid related studies will be offered participation in this study. the first test for eye fluid and saliva will occur at home with remote monitoring. participants will be mailed a specimen collection kit, engage in a remote session with a study coordinator through a hippa (health insurance portability and accountability act of 1996)-compliant video meeting and collect specimens under supervision of the study coordinator. patients will receive a schirmer's strip to place in both eyes without topical proparacaine, and a tube to collect saliva. the strips are then sent to the lab in universal viral transport media. patients who have positive covid-19 rna in tears will get repeat schirmer's test every 4 weeks for 3 months- independent of the nasopharyngeal test results. after a 3-month period, they will be offered a clinic visit at vei (vanderbilt eye institute) for full dilated eye exam, fluorescein angiography and aqueous biopsies. lab testing for covid-19 rna and other ocular inflammatory mediators will be performed by dr. johnathan schmitz's lab at vumc under standard viral precautions. all lab analysis will be performed under a research protocol and not for clinical assessment or reporting.

Eligibility criteria:
inclusion criteria: * patients who underwent covid-19 testing at vumc, tested positive, and had provided a written informed consent to participate in future covid related studies will be offered participation in this study. exclusion criteria: * patients under 18. * patients who do not speak spanish or english

Keywords: positive covid 19 ophthalmology eye diseases
safety and efficacy of unrelated umbilical cord blood microtransplantation in patients with aml

Conditions: Acute Myelocytic Leukemia

Summary: this study aimed to evaluate the safety and efficacy of unrelated umbilical cord blood microtransplantation in the treatment of aml patients by observing the factors related to the efficacy and adverse reactions.


Eligibility criteria:
inclusion criteria: 1. patients diagnosed with aml through bone marrow morphology, histochemistry, immunophenotyping, pathological testing, etc. besides, patients should meet the following conditions: patients aged 60-80 who newly diagnosed aml with who criteria and have not received prior treatment for acute leukemia (hydroxyurea or pre-chemotherapy is allowed for patients with high leukocyte). patients aged 14-60 who do not meet the indications for hematopoietic stem cell transplantation; 2. gender and race are not limited; 3. karnofsky score ≥ 60%, eastern cooperative oncology group (ecog) performance status ≤ 2; 4. expected survival time ≥ 3 months; 5. the examination results meet the following requirements: alt and ast ≤ 3 × upper limit of normal value (uln); total bilirubin ≤ 3 × uln; creatinine ≤ 2 × uln or creatinine clearance rate ≥ 40ml/min; the left ventricular ejection fraction (lvef) measured by echocardiography or multigated acquisition (muga) scanning is within the normal range (\>50%); 6. the recipient and selected donor should be 0-3/10 hla-matched with same blood type; 7. patients who voluntarily participate in this clinical study and have signed an informed consent. exclusion criteria: 1. patients who have suffered from malignant tumors; 2. patients have suffered from hematopoietic failure after chemotherapy, and have undergone ineffective blood transfusion with unknown cause; 3. patients who have undergone class ii or above surgery within 4 weeks prior to enrollment; 4. suffering from life-threatening diseases other than aml; 5. allergic to the drugs in the research; 6. patient with severe cardiac insufficiency, including uncontrolled or symptomatic arrhythmia, congestive heart failure, myocardial infarction within 6 months, or any grade 3 (moderate) or grade 4 (severe) heart disease; 7. patients with test positive for hiv, hcv or hbv; 8. stroke or intracranial hemorrhage occurred within 6 months prior to enrollment; 9. warfarin or vitamin k antagonists (such as phenprocoumarin) is necessary for anticoagulation; 10. patients with mental illnesses or cognitive impairments; 11. patients have participated within the month prior to enrollment or patients are currently participating in other clinical trials; 12. there are other conditions that the investigators consider inappropriate for inclusion.
effect of treatment with stress-doses glucocorticoid in patients with acute respiratory distress syndrome (ards)

Conditions: Acute Respiratory Distress Syndrome; Adrenal Insufficiency

Summary: the purpose of this study is to see if stress doses of hydrocortisone improve early outcome in patients who are in early stage of ards and with relative adrenal insufficiency.


Eligibility criteria:
inclusion criteria: * within the first 3 days of onset of clinically definite ards confirmed by aecc criteria in 1994 * 18 to 85 year old exclusion criteria: * pregnancy or lactation * tumor or other immunologic disease * immunosuppressive drug used * bone marrow or lung transplantation * primary or secondary disease of adrenal gland * hormone used within 3 months * refusing conventional therapy * be in other clinical tests within 30 days

Keywords: acute respiratory distress syndrome glucocorticoid adrenal insufficiency
effect of vitamin a supplementation on immune responses in human neonates

Conditions: Vitamin A Deficiency

Summary: vitamin a supplementation (vas) significantly reduces all-cause mortality when given after 6 months of age, but has a null or detrimental effect when given between 1-5 months. studies of neonatal vas (nnvas) have produced conflicting findings. these age-pattern variations might result from immunological interactions between vas and vaccines. the potential efficacy of nnvas is being retested in 3 large new intervention trials with mortality as endpoint. complementary mechanistic studies in animals and in human infants in the gambia (this proposal) and bangladesh have been commissioned to run in parallel. the investigators will use a 2-arm double blind rct to test whether nnvas modulates the early ontogeny of human immune development. neonates, recruited through a peri-urban clinic in the gambia, will receive either 50,000 international units (iu) vas orally within 48 hours of birth (intervention group, n=100) or a placebo (control group, n=100). male and female neonates will be randomized separately at enrolment for later analyses by sex. all infants will be followed up from birth to age 1 year. a broad panel of immunological outcomes will examine whether nnvas: a). normalises thymic development (thymic index by ultrasound); b). skews mycobacterial and recall antigen responses towards a th2 profile; c). diminishes th1 and th17 reactivity to mycobacterial and recall antigens; d). diminishes the tuberculin skin test (tst) response; e). causes increased innate immune reactivity; f). increases the frequency of circulating regulatory t cells (tregs) expressing gut homing receptors; g). enhances b cell immune responses after routine vaccination (increase of b cell numbers and activation status); h). increases circulating iga in mucosal immune compartment, especially oral polio vaccine (opv) specific iga post-vaccination; i). decreases bacterial translocation, by improving mucosal barrier function; and j). decreases markers of infection or inflammation. growth and morbidity will also be assessed.


Eligibility criteria:
inclusion criteria: * singleton birth, * birth weight ≥1,500g, * mother over 18 years willing to participate and residency within the study area. * birth vaccinations and vitamin a supplement must be administered within 48 hours of birth. exclusion criteria: * infants having a congenital disease, * a serious infection at birth * an inability to feed (initially assessed by the lack of the suck reflex), * mothers who are seriously ill at time of enrolment (defined as bed bound for more than 24 hours), * mother participating in other studies, * mothers who are hiv positive.
occipital nerve rf between occipital nerve block and occipital nerve radiofrequency ablation

Conditions: Occipital Neuralgia; Headache

Summary: this is a randomized, double blind, single-center, clinical trial. the study will be conducted over a period of 6 months. the study will be conducted at the allevio pain clinic, toronto, canada.

during the first visit the investigator will assess potential subject's eligibility. screening and recruitment, and randomization, and administer questionnaires will be performed by research coordinator. study informed consent form (icf) can be signed on the rf procedure day. if additional visits will be required to finalize the procedures related to the first visit they will be scheduled accordingly. after randomization the qualified participants will be scheduled for their bilateral occipital rf or bilateral occipital block. participants will be asked to complete the follow-up questionnaires at baseline, 3 and 6 months. on their last study visit, participants will have an exit interview, in addition to completing study measures.

Eligibility criteria:
inclusion criteria: * age 18-90 * confirmed diagnosis of occipital headaches, patients with concurrent other types of headaches will not be excluded (except undiagnosed headaches) * duration of occipital headaches \> 3 months exclusion criteria: * non-english speakers; * refusal to sign informed consent; * allergy to medications which will be used in the study; * concurrent undiagnosed headaches * current brain tumors * current known tumors with known metastasis in other organs * occipital blocks within the last 3 months * currently receiving treatment with botox for migraine. * patient has rf of occipital nerve/s within the last year
long-term comparison of stenting versus off-pump coronary bypass surgery

Conditions: Coronary Artery Disease

Summary: the randomized comparison of two strategies in coronary revascularization: bypass surgery without the use of a heart lung machine and coronary stenting procedure. the comparison comprised the occurrence of cardiac adverse events after the procedure. in addition, costs, cognitive outcomes and angiography were assessed.

coronary artery bypass surgery with use of the heart lung machine (on-pump surgery), is associated with the risk of peri-operative complications such as death, stroke, myocardial infarction, neurocognitive decline, and extended hospitalization. bypass surgery on the beating heart without the use of the heart lung machine (off-pump surgery) has been reintroduced in clinical practice in order to reduce these complications. the octopus cardiac wall stabilizer, developed at the umc utrecht, facilitates the safe construction of the grafts during the off-pump procedure. the expected advantages of off-pump surgery e.g. less-invasiveness, complete arterial revascularization, faster recovery and lower costs were the basis for the octostent trial. we hypothesized that the off-pump surgical technique might offer an alternative for angioplasty with bare-metal stent-implantation. the current study was designed as a randomized controlled multicenter trial comparing two strategies.

Eligibility criteria:
inclusion criteria: * patients with coronary artery disease referred for pci in which both off pump coronary bypass surgery and pci were deemed technically feasible exclusion criteria: * a history of cabg or stenting * emergency or concomitant major surgery * q-wave myocardial infarction in the last six weeks * inability to give informed consent

Keywords: symptomatic coronary artery disease patients
open non-comparative clinical trial study to evaluate the performance and safety of ainara®

Conditions: Vaginal Disease

Summary: this study evaluates treatment with the medical device ainara on the improvement of vaginal dryness evaluated by vaginal health index (vhi) and visual analog scale (vas) in comparison with the baseline condition.

detailed description: this is an open, non-comparative, multicenter study that evaluates the performance and safety of the medical device ainara. in this study the investigators use polycarbophilic vaginal moisturizing gel (ainara) for symptomatic treatment of vaginal dryness and monitor its impact on vaginal dryness symptoms.

Eligibility criteria:
inclusion criteria: * post-menopausal women (total cessation of menses for ≥ 1 year) according to the straw criteria, aged ≥ 50 to ≤ 70 years; * diagnosis of vaginal dryness by: * subjective dryness, any objective sign of vva, ph\>5 as reported in the agata study * vhi \< 15. * body mass index (bmi) ≥ 18.5 to ≤ 36 kg/m2; * able to communicate adequately with the investigator and to comply with the requirements for the entire study. capable of and freely willing to provide written informed consent prior to participating in the study. exclusion criteria: * malignancy (also leukemic infiltrates) within 5 years prior to day 0 (except for treated basal cell/squamous cell carcinoma of the skin). * genital bleeding. * estrogen vaginal treatment during the study period (it was permitted only if terminated at least 6 months before study). * systemic estrogen therapy (it was permitted only if terminated at least 6 months before study). * subjects with illness, or other medical condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the study or be likely to lead to hospitalization during the course of the study. * clinical evidence of acute infection currently requiring treatment (syphilis, herpes simplex, human papilloma virus, gonorrhea, chlamydia, lymphogranuloma venereum, etc.); clinical evidence or history of chronic infectious disease (i.e. tuberculosis). * psychosis, schizophrenia, mania, depressive disorders, history of suicide attempt or suicidal ideation, or any other psychiatric illness (except for intermittent anxiety). * known allergy to tested imds or its excipients. * drug or alcohol abuse in the 12 months prior to day 0. * participation in an interventional clinical study or administration of any investigational agents in the previous 30 days. * presence of any clinically significant medical condition judged by the investigator to preclude the patient's inclusion in the study
effects of coherent breathing breathwork on health

Conditions: Stress; Anxiety; Depressive Symptoms; Wellbeing; Sleep Disturbance

Summary: the investigators are conducting a randomised-controlled trial comparing coherent breathing at \~5.5 breath cycles per minute-bcpm (with equal inhalation/exhalation durations of \~5.5secs each) to a well-designed placebo (paced breathing at 12bcpm with equal inhalation/exhalation durations of 2.5secs each). the metric of 12bcpm is in line with guidance from the british journal of nursing, royal college of physicians, and johns hopkins university which state that the average, healthy bcpm should range from: 12-20bcpm, 12-18bcpm, and 12-16bcpm, respectively, hence the investigators chose the minimum/lower bound for the active placebo control group. the main questions that our study attempts to address are: does coherent breathing (and placebo coherent breathing) lead to improved mental health and wellbeing in a general population adult sample? the study will be conducted entirely online through the research platform prolific, so participant data will be anonymous. the investigators will collect self-reports of mental health and wellbeing before and after the four-week breathwork period, along with a follow-up one-month later. pre-post intervention and follow-up questionnaires will be completed online via the survey platform qualtrics which will be linked to prolific. participants will also be asked how many times they practiced out of the assigned 28 days, to gauge self-reported adherence to the protocol. the investigators can then observe whether self-reported adherence correlates with changes in mental health and wellbeing, if any. data on the self-reported credibility/expectancy of the breathwork randomly allocated to participants will also be collected, along with open-ended responses on participants' overall experience of the protocol/study.


Eligibility criteria:
inclusion criteria (self-assessed): * 18+ years of age (18 is the automatic minimum age on prolific) * able to breathe through nose * have access to headphones * the following pre-screeners on prolific will also be set so only those eligible on prolific will see the study: located/living in uk, fluent in english, approval rate of 98% and at least 20 previous submissions (as recommended by prolific to increase retention and reduce dropout rates in longitudinal and multi-part studies) exclusion criteria (self-assessed): * any problems which affect ones ability to pace their breathing (i.e., active/chronic respiratory infection including blocked nose/cough/cold/fever, etc.), breathlessness, cardiovascular problems, respiratory conditions or diseases (i.e., uncontrolled symptomatic asthma, copd, lung cancer, etc.), abnormally slow breathing (bradypnea), or abnormally fast breathing (tachypnoea) * any other physical/mental health conditions or current life events which impair or affect ones ability to engage in activities involving breath control
honest placebos with explanations: evaluating open-label placebos for chronic pain

Conditions: Chronic Low-back Pain; Chronic Pain

Summary: the goal of this clinical trial is to examine the effect of rationale condition when taking open-label placebos on pain by 1) comparing each rationale to the no rationale control condition and the no treatment control condition; and 2) comparing the rationale conditions to each other. we also aim to examine the effect of rationale condition on prescription opioid use by 1) comparing each rationale to the no rationale control condition and the no treatment control condition; and 2) comparing the rationale conditions to each other. this study will include patients with chronic low back pain. the main question it aims to answer is: how do rationales influence the effects of open-label placebos? researchers will compare different rationales given when taking an open-label placebo and a no-treatment group and a no rationale group taking olps.


Eligibility criteria:
inclusion criteria are: * chronic pain (pain lasting at least 3 months, pain intensity 4/10 or over and interference 3/10 or over) * at least 18 years old * english speaking * have a smartphone or computer with video access * the chronic pain is concentrated into the patient's lower back (tentative criteria based on recruitment rate) exclusion criteria * have chronic pain because of a cancer diagnosis * over 89 years of age * suspect an allergy to any placebo ingredient * currently receiving worker's compensation.

Keywords: open-label placebo rationales placebo effect