Kornimate/medical-research-clean huggingface dataset:
staying well: a clinical trial of mindfulness-based stress reduction and education groups for hiv

Conditions: HIV

Summary: to examine the effects of mindfulness-based stress reduction (mbsr) and education groups on hiv (human immunodeficiency syndrome) infection. key outcomes include cd4 and viral load, stress hormones, depression and quality of life.

stress and depression are associated with more rapid loss of cd4 cells in hiv infection. interventions that slow the advance of hiv infection and delay the introduction of antiretroviral therapy (art) could make an important contribution to hiv management in both the developed and developing world. we are conducting a 330 person randomized, controlled clinical trial of mbsr for persons with hiv-1 infection and cd4 t-lymphocyte counts \> 250 cells/µm who are not on antiretroviral therapy. participants are randomized in a 1:1 distribution to either the mbsr intervention or to an education group that will control for the attention and social interaction aspects of mbsr. participants are evaluated at 0, 3, 6 and 12 months. key outcome measures at 12 months include differences in cd4 t cell counts, hiv viral load, perceived stress, depression, and positive affect. we are also examining whether mbsr is associated with changes in neuroendocrine function (autonomic nervous system activity, cortisol secretion) and alterations in immune function that may serve as intermediate steps between the neuroendocrine effects of mbsr and cd4 t cell counts, such as changes in t cell activation. a subset of 90 participants will be studied in additional detail using a structured laboratory stress challenge.

Eligibility criteria:
inclusion criteria: * hiv+ * viral load\>100 * cd4 t-cells\>250 * not on antiretroviral therapy (art) * ability to speak english * stable address/living situation exclusion criteria: * inability to provide informed consent * use of art within the past 120 days * any substance abuse,mental health or medical condition that the opinion of the principal investigator (pi) would make it difficult for the potential participant to participate in the intervention * plans to start art in the next 12 months * previous mbsr training and/or current practice * current use or use in past 6 months (mos.) of chemotherapy or immunomodulator drugs, including oral steroids or plans to start in the next 12 mos. * initiation of new class of psychiatric medication in past 2 months.

Keywords: hiv meditation stress randomized controlled trial complementary therapies mbsr not on art medications
extension study of abp-671 in participants with gout

Conditions: Gout

Summary: the primary objectives of this study are to assess the safety, tolerability, and efficacy of abp-671 in lowering serum uric acid (sua) in participants with gout who roll over from study abp-671-301 after they complete the double-blind 28-week treatment period of part 1 (phase 2b) or part 2 (phase 3).


Eligibility criteria:
inclusion criteria: * must have completed the double-blind treatment period in study abp-671-301 (part 1 or part 2) and are actively receiving and tolerating the study drug up to the week 28 visit in study abp-671-301 exclusion criteria: * has a new medical or psychological condition that, in the opinion of the investigator and/or medical monitor, might create undue risk to the participant, interfere with the participant's ability to comply with the protocol requirements to complete the extension study, or potentially compromise the results or interpretation of the extension study. * is planning to become pregnant or breastfeed during the study or within ≤30 days after the last dose of the study drug. * is intolerant or unwilling to take colchicine or naproxen.
ultrasound guided single shot block of posterior tibial nerve for postoperative pain relief after hallux valgus surgery

Conditions: Hallux Valgus

Summary: hallux surgery is known to be extremely painful. standard pain therapy is treatment with nsaid and opioid painkillers. patients are frequently not-satisfied with this. some institutions use a nerve block (single shot or catheter technic) of the ischiadic nerve. but this procedure is invasive, has a potential risk of nerve lesion, and is not accepted by all surgeons. a single shot nerve block of the posterior tibial nerve is less invasive and could be superior compared to standard pain treatment. a great variability of nerve supply of the foot is well described. there are some hints that the posterior tibial nerve supplies the first metatarsal bone and the first metatarsal joint. a nerve block could reduce postoperative pain in hallux surgery. to assess the effectiveness of this investigated measure, the requested morphine dose of a pca pump will be used to verify the effectiveness of the tibial nerve block.

the overall purpose is to evaluate the effectiveness of tibial nerve block for postoperative pain relief after hallux surgery. the primary objective is to assess the morphine requirement in the first 24 hours after surgery. secondary objectives are maximum pain scores and sleeping quality in the postoperative period. patient's satisfaction with the pain therapy and approximately nerve block duration will be asked in the final interview. primary study endpoint is a 50% reduction of morphine requirement with a 60% standard deviation within 24 hours after surgery. power is 80%, the level of significance is set at 5% (p \< 0,05). secondary endpoints are sleeping quality and maximum pain scores (maximum vas) measured by means of postoperative questionnaire.

Eligibility criteria:
inclusion criteria: * age over 18 years * elective hallux valgus surgery ("magerl" operation technique) exclusion criteria: * patient refusal, pregnancy * regular medication with opioids * drug abuse * contraindication for regional anesthesia * known allergy against one of the study drugs * polyneuropathia, or any other neurodegenerative disorders
extracorporeal shock wave therapy for the treatment of erectile dysfunction

Conditions: Erectile Dysfunction

Summary: low intensity shockwaves have been proven in animal studies to induce local growth of new blood vessels from existing ones. the hypothesis of this study is that shockwave therapy could improve the symptoms of patients with erectile dysfunction resulted from a vascular origin and respond to pde-5 inhibitors.

low intensity shockwaves (1/10 the ones used in lithotripsy) are delivered to the penile tissue. shockwaves are created by a special generator and are focused using a specially designed shockwave applicator apparatus. the shockwaves are delivered trough the applicator covering the corpora cavernosa of the penis.

Eligibility criteria:
inclusion criteria: * ed of more than 6 months * at least 50% unsuccessful to attempt sexual intercourse for 4 times at 4 different days * positive response to pde-5 inhibitors * iief-5 domain score of 12-20 denoting mild to severe ed * non-neurological pathology * stable heterosexual relationship for more than 3 months exclusion criteria: * npt - normal/flat * prior prostatectomy surgery * any cause of ed other than vascular related * any unstable medical, psychiatric, spinal cord injury, penile anatomical abnormalities * clinically significant chronic hematological disease * cardiovascular conditions that prevent sexual activity * history of heart attack, stroke or life-threatening arrhythmia within the prior 6 months. * cancer within the past 5 years. * anti-androgens, oral or injectable androgens * use of any treatment for ed within 7 days of screening including oral medications, vacuum devices, constrictive devices, injections or urethral suppositories

Keywords: ed erectile dysfunction erectile dysfunction treated with pde-5 inhibitors
effects of daily home hemodialysis on circulation, mental functions, and quality of life

Conditions: End-Stage Renal Disease

Summary: this study was designed to discover mechanisms responsible for the decrease in (high) blood pressure after starting daily hemodialysis, as has been observed by various investigators. we hypothesized that better control of body water and sodium content and a decline in the autonomic (sympathetic) nervous system activity, increased in chronic renal failure patients, would contribute to improved blood pressure regulation. moreover, we studied the effects of daily hemodialysis on mental functions, like information processing and memory, in relation to the previously reported improvement in quality of life, and the effects on nutrition. we hypothesized that all would improve.

although conventional hemodialysis has faced many technical improvements in recent years, a great deal of end-stage renal disease patients, treated with this modality, have suboptimal or high blood pressure, and suffer poor quality of life. daily hemodialysis has been reported to improve both, but the pathophysiological background is poorly understood. patients were studied before and after 6 months of daily (i.e.6 times a week) home hemodialysis, and again after two months of conventional (i.e. thrice weekly) hemodialysis. we measured the effects of daily dialysis (compared with conventional dialysis) on blood pressure, cardiac output, extracellular fluid volume, plasma renin activity, sympathetic nervous system activity (through msna), the electroencephalogram (eeg), neurocognitive functioning (speed of information processing, memory, executive functioning, and attention), quality of life, and nutritional status

Eligibility criteria:
inclusion criteria: * end-stage renal disease patients * fit and motivated for home hemodialysis exclusion criteria: * patients, who were treated with frequent dialysis (5 or 6 times a week) before * diabetes mellitus * severe comorbidity (e.g. malignancies)
does micropattern on urinary catheter surface reduce urinary tract infections?

Conditions: Catheter Associated Urinary Tract Infections

Summary: the aim of this study is to determine if the sharklet catheter, with its unique surface micropattern, reduces infections in participants, when compared to a standard silicone catheter.

the aim of this study is to determine if the sharklet catheter, with its unique surface micropattern, reduces infections in participants, when compared to a standard silicone catheter.

Eligibility criteria:
inclusion criteria: * patient requires a chronic indwelling foley catheter for at least 3 days. * catheters will not remain indwelling greater than 30 days at a time * patient is more than 18 years of age * patient is able to give informed consent * patient is able to attend follow-up sessions exclusion criteria: * patient is less than 18 years of age * patient is pregnant * patient with a known allergy to silicone * patient has urinary tract anatomic abnormality that would prevent placement of a standard foley catheter * patient unable to accommodate the catheter * patient has an active urinary tract infection (uti) or other diagnosed infection that is untreated. * patient currently taking (or expected to take) more than a single dose of antibiotics for prevention of other infections during the catheter indwell period * patient has uncontrolled fecal incontinence (uncontrolled stool/poop passage) * patient is unable to feel and/or communicate their symptoms * informed consent is unable to be obtained * patient is unable or unwilling to comply with the study follow-up schedule * patient has a medical condition or disorder that would limit life expectancy to less than 30 days or that may cause non-compliance with the protocol or confound the data analysis * any other reason that if in the opinion of the investigator would make the patient unsuitable for enrollment in the study

Keywords: cauti biofilm urinary tract infections micropattern catheter
study of skin toxicity of cetuximab: find a link between skin inflammation and tumor response

Conditions: Metastatic Colon Cancer

Summary: colon cancer is one of the most common cancers in france with more than 36,000 new cases per year. despite significant advances in therapeutic care, the prognosis of colon cancers with metastases remains bad. the treatment of metastatic disease is based on chemotherapy coupled with therapeutic antibodies. the most commonly used are anti-egfr (epidermal growth factor receptor), which allowed a significant increase in patient survival. they are responsible for skin toxicity in the form of an acneiform rash which can be debilitating for patients and require discontinuation of treatment. however, this toxicity is strongly correlated with treatment efficacy. understanding the mechanisms of cutaneous side effects of anti-egfr is therefore a major challenge to treat and better understand the association with treatment efficacy. the objective of this study is to investigate a link between cutaneous inflammatory response in patients treated with anti-egfr, serum level of anti-egfr and treatment efficacy. it will be conducted systematic consultations dermatology, skin biopsies and blood samples in patients treated with anti-egfr. from biopsies, it will be searched by an infiltration of inflammatory cells and expression of genes involved in skin inflammation.


Eligibility criteria:
inclusion criteria: * patients older than 18 years * patient with histologically proven metastatic colorectal cancer with kras wild-type * treatment with cetuximab in first line chemotherapy combined with folfox or folfiri * patient has signed informed consent * patient affiliated to the social security * prescription of cetuximab in agreement with the summary of product characteristics exclusion criteria: * patients aged under 18 * patients taking immunosuppressive therapy * patient having a severe skin disease * no measurable metastasis * patients with a contra-indication of cetuximab: hypersensitivity to cetuximab or to any excipients * severe alteration of respiratory or cardiac function or severe coronary disease * patients with contra-indication to chemotherapy folfox and folfiri * participation in another research protocol * patients not affiliated to the social security * hospitalized patients without consent * pregnant or nursing women, women of childbearing age with no effective contraception
confirmatory study of opc-12759 ophthalmic solution

Conditions: Dry Eye

Summary: the purpose of this study is to verify whether opc-12759 ophthalmic solution is effective compared with placebo in dry eye patients. opc-12759 ophthalmic suspension will be used as a reference drug.


Eligibility criteria:
inclusion criteria: 1. out patient 2. subjective complaint of dry eye that has been present for minimum 20 months 3. ocular discomfort severity is moderate to severe 4. corneal - conjunctival damage is moderate to severe 5. unanesthetized schirmer's test score of 5mm/5minutes or less 6. best corrected visual acuity of 0.2 or better in both eyes exclusion criteria: 1. presence of anterior segment disease or disorder other than that associated with dry eye 2. ocular hypertension patient or glaucoma patient with ophthalmic solution 3. anticipated use of any topically-instilled ocular medications or patients who cannot discontinue the use during the study 4. anticipated use of contact lens during the study 5. patient with punctal plug 6. any history of ocular surgery within 12 months 7. female patients who are pregnant,possibly pregnant or breast feeding 8. known hypersensitivity to any component of the study drug or procedural medications 9. receipt of any investigational product within 4 months.
deep learning enabled endovascular stroke therapy screening in community hospitals

Conditions: Acute Ischemic Stroke (AIS)

Summary: after onset of acute ischemic stroke (ais), every minute of delay to treatment reduces the likelihood of a good clinical outcome. a key delay occurs in the time between completion of computed tomography (ct) angiography of the head and neck and interpretation in the setting of ais care. the purpose of this study is to assess the effect of incorporating viz.ai software, which via via a machine-learning algorithm performs artificial intelligence-based automated detection of large vessel occlusions (lvo) on ct angiography (cta) images and alerts the ais care team (diagnosis and treatment decisions will be based on the clinical evaluation and review of the images by the treating physician, per routine standard of care). the hypothesis is that integration of the software into the ais care pathway will reduce delays in treatment. a cluster-randomized stepped-wedge trial will be performed across 4 hospitals in the greater houston area.


Eligibility criteria:
inclusion criteria: * male or female * 18 years of age or older. * patients who present to the emergency department with signs and/or symptoms concerning for acute ischemic stroke. * patients who undergo ct angiography imaging * patients determined to have a large vessel occlusion acute ischemic stroke. this determination will be made based on official radiology report for the ct angiography imaging. exclusion criteria: * patients with incomplete data on the electronic medical record.
flt-pet imaging for mds

Conditions: AML; MDS

Summary: the main purpose of this study is to see if this tracer can be used to determine how well chemotherapy is working in patients with certain types of leukemia.

primary objectives 1. to evaluate if flt-pet uptake shows variation during the treatment course in subjects with mds being treated with 5-azacitidine therapy secondary objectives 2. to assess flt-pet uptake heterogeneity within given subjects being treated with 5-azacitidine therapy 3. to generate preliminary data regarding correlation between flt-pet imaging parameters and clinical responses based on bone marrow aspirate/biopsy

Eligibility criteria:
inclusion criteria: * all subjects with previously untreated, intermediate-2 or high risk myelodysplastic syndrome are eligible. these patients have an international prognostic scoring system (ipss) score of 1.5 to 3.5 based on bone marrow blast percentage, karyotype, and the number of cytopenias 26. * subjects will receive the standard fda-approved dose and schedule of 5-azacitidine. this dose is 75mg/m2 sq or iv daily for seven days with cycles repeated every 28 days * the subject's treating physician must have an initial intent of treating with at least four cycles of therapy * subjects must have an ecog performance status of 0, 1, or 2 * subjects must not have been treated with chemotherapy or radiation for another malignancy within the preceding 6 months * subjects must be \> 18 years of age * subjects must have a serum creatinine \< 2.0 mg/dl and/or calculated ghf 50 ml/min/1.73m (mrdr formula) or greater * subjects must have a serum direct bilirubin \< 2.0 mg/dl unless related to gilbert's syndrome of hemolysis. alkaline phosphatase, sgot (ast), and sgpt (alt) must be less than 4 x upper limit of normal * women must not be pregnant nor breastfeeding * women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception exclusion criteria: * subjects who are pregnant or breast feeding * subjects for whom a therapy other than 5-azacitidine is recommended as first line treatment. * allogeneic stem cell transplantation in patients with a suitable donor, lack of comorbidities, and good performance status

Keywords: mds aml 5 azacitidine flt pet
physical activity profile and sedentary behaviour in adults with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: cystic fibrosis is a multisystem genetic disease whose severity, linked to the nature of the mutation in the gene carried, is linked to respiratory impairment, which determines the vital prognosis. considerable progress has been made in the management of this disease, amplified in recent years by the arrival of cftr (cystic fibrosis transmembrane conductance regulator) modulator drugs, and in particular the triple treatment combination of elexacaftor-tezacaftor-ivacaftor (eti). this modulator therapy improves clinical condition, particularly respiratory, and transforms quality of life and prognosis for some patients. faced with this clinical improvement, practices and care paths are adapting. professionals will have to cope with the emergence of new clinical conditions linked to the ageing of this at-risk population and the functional decline due to a sedentary lifestyle and age. the working hypothesis is that a better understanding of the physical activity and sedentary lifestyle profiles of the adult population with cystic fibrosis, and in particular the characterization of the profile of inactive and high sedentary patients under eti, will enable us to identify and target patients whose lifestyle habits reflect a greater health risk, and for whom care by rehabilitators and adapted physical activity (apa) teachers and personalized advice could be put in place. the aim of this study is to characterize the physical activity and sedentary profile of adults with cystic fibrosis. activmuco is an observational, cross-sectional, single-center study. a subgroup of adults with high sedentary and inactive under eti will be studied more specifically by actimetry (prospective follow-up) and interview.


Eligibility criteria:
inclusion criteria: * patients (male or female) of legal age, * patients with cystic fibrosis (cf) regularly followed at hôpital lyon sud's cystic fibrosis center, who volunteered to take part in the study. exclusion criteria: * people who, due to the presence of co-morbidities, do not have motor and cognitive skills compatible with independent walking or orthostatic physical activity. * people whose clinical situation contraindicates the practice of adapted physical activity * pregnant women * people who do not have the intellectual or linguistic capacity to understand the questionnaires * persons deprived of their liberty by judicial or administrative decision * persons under psychiatric care * persons admitted to a health or social establishment for purposes other than research * adults under legal protection (guardianship, curatorship). * persons not affiliated to a social security scheme or beneficiaries of a similar scheme

Keywords: cystic fibrosis exercise sedentary lifestyle
a prospective study of a mosaic embryo transfer

Conditions: Infertility

Summary: this research is a prospective study in which the purpose is to investigate the clinical outcomes following the transfer of a mosaic embryo (presence of both chromosomally normal and abnormal cells) that has been screened for preimplantation genetic testing (pgt).

this research is a prospective study with the purpose is to investigate the clinical outcomes following the transfer of a mosaic embryo (presence of both chromosomally normal and abnormal cells) that has been screened for preimplantation genetic testing (pgt). pgt involves the biopsy and testing of a handful (3-6) of trophectoderm (pre-placental cells) from the embryo. embryos that are screened as mosaic via pgt, as a standard, are not offered for transfer for pregnancy attempt. publications have shown that mosaic embryos and mosaic fetuses can result in healthy live births (wallerstein et al, 2015; victor et al, 2019). ongoing clinical outcomes are important to further understand the association between an embryonic mosaic biopsy of pre-placental cells and subsequent fetal chromosomal constitution. implantation rates and live birth rates will be evaluated to help understand if mosaic embryos should routinely be offered for transfer to patients attempting pregnancy.

Eligibility criteria:
inclusion criteria: * women age 18-45 infertile women who have completed an ivf cycle with pgt at the colorado center for reproductive medicine (ccrm) that have a mosaic embryo * patients can be of any race, culture, sexual orientation or ethnicity * patients that are willing to transfer a single embryo exclusion criteria: * patients that do not meet the clinical requirements for an embryo transfer per clinic standards. * patients that desire more than a single embryo transfer. * patients that are using a gestational carrier. * embryonic mosaic pgt results that include chromosome errors 13, 18, 21 * patients that did not complete their ivf with pgt cycle at the colorado center for reproductive medicine.