Kornimate/medical-research-clean huggingface dataset:
using grassroots wellness coaching to enhance reach and sustainability of behavioral weight management

Conditions: Obesity

Summary: african american adults that live in economically disadvantaged areas are at an increased risk for obesity and cardiometabolic disease. the treatment program being tested in this research study aims to address these factors and increase outcomes for the study population. the purpose of this research study is to find out about the feasibility and acceptability of using house chats (hc) as a model for a weight loss program in a real-world, community-based setting.


Eligibility criteria:
inclusion criteria: * age 18 and older * resident of petersburg, va * interested in engaging community members in healthy lifestyle changes (e.g., walking, small changes to eating) and willing to engage in these behaviors her/himself exclusion criteria: * a diagnosis of type 1 diabetes mellitus. * currently being treated for cancer. * medical conditions that may increase risk for participating in unsupervised exercise, if medical clearance is not provided * hospitalization for depression or other psychiatric disorder within the past 12 months. * lifetime history of bipolar disorder or psychotic disorder. * currently pregnant or lactating, or planning to become pregnant within the study period. * current involvement in a weight loss program or current use of weight loss medication. * inability to speak, read and write english. * planning to move from the petersburg area within the study period. * does not have sufficient numbers of individuals in their social network from which to recruit for the proposed study.

Keywords: cardiometabolic disease
quantitative determination of brain water content in patients during and after hepatic encepalopathy

Conditions: Hepatic Encephalopathy

Summary: there is increasing evidence that the pathophysiology of hepatic encephalopathy (he) is tightly associated with low-grade cerebral edema. uptake of ammonia in astrocytes leads to osmotic swelling caused by glutamine formation. previous studies were performed in covert he patients or used indirect methods. methods: the investigators wish to describes quantitative measurement of localized water content using mri water mapping in a cohort of patients with cirrhosis during an episode of overt he type c and again after recovery. furthermore patients with cirrhosis and no history of he and healthy subjects will be investigated as controls.


Eligibility criteria:
inclusion criteria: * patients with type c he during and after he, * patients with stable cirrhosis and * healthy subjects exclusion criteria: * patients with pace-maker * metal implants
lactobacillus reuteri dsm 17938 in preventing nosocomial diarrhea in children

Conditions: Diarrhea

Summary: aim: to determine the efficacy of lactobacillus reuteri dsm 17938 at a dose of 10(9) cfu for the prevention of nosocomial diarrhea. trial design: double-blind, placebo controlled rct. intervention: l reuteri dsm 17938 in a daily dose of 10(9) cfu. primary outcome: nosocomial diarrhoea (3 or more loose or watery stools in a 24 h that will occur more than 72 h after admission).

nosocomial diarrhea is a common problem in hospitalized children. previously, it has been documented that the administration of l reuteri dsm 17938 at a dose of 10(8) colony forming units (cfu) compared with placebo had no effect on the overall incidence of nosocomial diarrhea (wanke \& szajewska, j pediatr 2012). whether higher doses of l reuteri dsm 17938 have such effects needs to be substantiated in further randomized trials.

Eligibility criteria:
inclusion criteria: * children aged 1-48 mo admitted to the hospital for reasons other than diarrhea * signed informed consent. exclusion criteria: * acute gastroenteritis within 3 days before admission * symptoms other than diarrhea suggesting gastroenteritis * use of probiotics within 7 days before admission * immunodeficiency disorders * breastfeeding \>50% * underlying gastrointestinal tract disorder * malnutrition (weight/high \<3pc)

Keywords: nosocomial diarrhea lactobacillus reuteri dsm 17938 rotavirus diarrhea probiotics
post approval study investigating lutonix drug coated balloon for treatment of dysfunctional arteriovenous fistulae

Conditions: Arteriovenous Fistula

Summary: this prospective, global, multicenter, single arm post-approval study is designed to investigate the clinical use and safety of the lutonix® 035 av drug coated balloon (dcb) pta catheter in subjects presenting with clinical and hemodynamic abnormalities in native arteriovenous (av) fistulae located in the upper extremity.

this post-market approval study (pas) is required by the fda as a condition of approval for the lutonix drug coated balloon catheter. it is intended to demonstrate safety and assess the clinical use and outcomes of the lutonix catheter in dysfunctional arteriovenous fistulae (avf) in a heterogeneous patient population in real world clinical practice.

Eligibility criteria:
inclusion criteria: 1. male or non-pregnant, non-breastfeeding female ≥18 years of age 2. subject is willing to provide informed consent, and is willing to comply with the protocol-required follow up visits 3. target lesion must be a mature arteriovenous fistula located in the arm presenting with any clinical, physiological or hemodynamic abnormalities warranting angiographic imaging as defined in the k/doqi guidelines 4. subject has a target lesion that can be treated with available lutonix dcb according to the instructions for use (ifu) 5. venous stenosis of an av fistula in which the target lesion is located from the anastomosis to the axillosubclavian junction, as defined by insertion of the cephalic vein 6. successful pre-dilation of the target lesion with an uncoated percutaneous transluminal angioplasty (pta) balloon defined as: 1. no clinically significant dissection; 2. no extravasation requiring treatment; 3. residual stenosis ≤30% by angiographic measurement; 4. ability to completely efface the waist using the pre-dilation balloon. exclusion criteria: 1. subject is currently participating in an investigational drug, biologic, or device study, or previous enrollment in this study 2. subject has a non-controllable allergy to contrast 3. subject has another medical condition that, in the opinion of the investigator, may confound the data interpretation or is associated with a life expectancy insufficient to allow for completion of subject study procedure and follow up 4. target lesion is located central to the axillosubclavian junction 5. a thrombosed access or an access with a thrombosis treated ≤7 days before to the index procedure 6. prior surgical interventions of the access site ≤30 days before the index procedure 7. target lesion is located within a bare metal or covered stent
saxon sars-cov-2 infection and vaccination study in dialysis patients, solid organ recipients and staff

Conditions: SARS-CoV-2 Infection; Active Immunization; Immune Response; Immunosuppression

Summary: to investigate short- (3 and 8 weeks) and long-term (6, 9, 12, and 18 months) immune protection or response at the humoral and cellular levels before and after sars-cov-2 infection or vaccination in patients with moderately reduced immune status (dialysis patients) and severely reduced immune status (organ transplant recipients, mostly kidney transplant recipients) and immunocompetent subjects (medical staff) in saxony, germany.

* formation of two separate cohorts of approximately 1000 study subjects each from the three categories (dialysis patients, solid organ transplant recipients and medical staff) of participants vaccinated using either biontech or moderna vaccine (biontech cohort and moderna cohort, approximately 2000 subjects total). * study time points: before administration of the 1st sars-cov-2 vaccine dose, before the 2nd vaccine dose, and 8 weeks and 6, 9, 12, and 18 months after administration of the 1st vaccine dose and after suspected or proven sars-cov-2 infection. * at all time points, a questionnaire or ecrf will be completed with questions about the dialysis center and the clinical course of the patients. * humoral immune response will be determined in all study participants. * formation of a study subgroup of up to 300 subjects in each cohort (biontech or moderna cohort) for detailed evaluation of the cellular immune response (max. 600 subjects in total). * in case of non-sustained immunity \> 6 months as well as the occurrence of a 3rd sars-cov-2 infection wave in autumn 2021, this will be investigated analogously to the current wave.

Eligibility criteria:
inclusion criteria: * dialysis patients, organ transplant recipients and medical staff * written consent to participate in the study exclusion criteria: * age \< 18 years old

Keywords: sars-cov-2 covid-19 dialysis immunosuppression solid organ transplantation kidney transplant recipients humoral immimmune response cellular immune response
fluorescence imaging of risankizumab-800cw in inflammatory bowel disease

Conditions: Ulcerative Colitis (UC); Crohn Disease (CD)

Summary: crohn\&#39;s disease (cd) and ulcerative colitis (uc) are chronic inflammatory bowel diseases (ibd). risankizumab is a human monoclonal antibody against il23 p19, part of a pro-inflammatory cytokine that mediates the inflammatory response in ibd upon binding to its receptor. primary non-response to risankizumab is high in both cd and uc. currently, there are no predictors of response to risankizumab and the actual mechanism of action has not yet been elucidated. to gain better understanding of the drug targeting of risankizumab in ibd, the university medical center groningen (umcg) developed fluorescently labeled risankizumab (risankizumab-800cw). this study aims to assess the safety and the optimal dose of risankizumab-800cw to visualize and potentially quantify the local drug concentration and predict treatment response in ibd patients using in vivo and ex vivo fluorescence molecular imaging (fmi).


Eligibility criteria:
inclusion criteria for part a: * established ibd diagnosis * active disease: clinically active disease of the bowel is defined clinically as at least mild activity using dedicated scoring indices or biochemically active disease as defined by a fecal calprotectin \&gt; 60 μg/g * patients must be eligible for risankizumab therapy * minimum age of 18 years * written informed consent * clinical indication for an endoscopic procedure inclusion criteria for part b: * established ibd diagnosis * patients must be on risankizumab therapy for at least 14 weeks * minimum age of 18 years * written informed consent * clinical indication for an endoscopic procedure exclusion criteria for part a: * a female study patient who is pregnant or provides breastfeeding * a female study patient of premenopausal age who does not use any reliable form of contraception at the time of risankizumab-800cw administration and the following 10 weeks * medical or psychiatric conditions that compromise the patient's ability to give informed consent * prior anti-il23-specific therapy (il23/il12 combination therapy is not an exclusion criteria) * active extra gastrointestinal manifestations of crohn's disease (e.g. uveitis or pyoderma gangrenosum at vital locations) exclusion criteria for part b: * a female study patient who is pregnant or provides breastfeeding * a female study patient of premenopausal age who does not use any reliable form of contraception at the time of risankizumab-800cw administration and the following 10 weeks * medical or psychiatric conditions that compromise the patient's ability to give informed consent * active extra gastrointestinal manifestations of crohn's disease (e.g. uveitis or pyoderma gangrenosum at vital locations)

Keywords: fluorescence molecular endoscopy inflammatory bowel disease risankizumab-800cw
management of malignant pleural effusion with indwelling pleural catheter versus silver nitrate pleurodesis

Conditions: Pleural Effusion, Malignant

Summary: the primary goal of this study is to compare well-defined pleural effusion management success outcomes in patients with malignant or paramalignant pleural effusions who were treated with indwelling pleural catheter insertion compared with those treated with siver nitrate pleurodesis. it is also to demonstrate the effectiveness of silver nitrate pleurodesis. it is also important to evaluate frequent adverse events of silver nitrate pleurodesis in patients with malignant pleural effusion

dyspnea is present in 50% of patients with malignant pleural effusion and quality of life is significantly impaired. chemical pleurodesis using various sclerosing agents is accepted as a palliative therapy for patients with recurrent, symptomatic, and malignant pleural effusions. silver nitrate solution (sns) is a valid sclerosing agent that induce a caustic injury to the mesothelium that results in an effective pleurodesis. however, various clinical parameters and biochemical factors affect the success of pleurodesis in symptomatic patients with mpe: symptoms and performance status of the patient, daily fluid drainage, primary tumour, and mainly lung reexpansion following pleural fluid evacuation. the pleural injectate consists of 50 ml 0.5% sns with 10ml of lidocaine (25mg/5ml). an alternative treatment is intermittent or continuous drainage of the pleural fluid with a chronic indwelling pleural catheter.

Eligibility criteria:
inclusion criteria: 1. unilateral symptomatic recurrent malignant pleural effusion patients who fulfill the criteria for pleurodesis (i.e. positive pleural biopsy or cytology for malignancy, a karnofsky index score of more than 60 and life expectancy of more than one year). 2. rapidly accumulated undiagnosed pleural effusion . 3. age : 30-75 years old. exclusion criteria: 1. transudative pleural effusion. 2. exudative pleural effusion due to causes other than malignancy ( i.e. parapnuemonic , post-tuberculous pleural effusion ) 3. presence of hemorrhagic diathesis ( prothrombin time \<50% and platelet count \<80,000/mm 3 ) 4. active pleural or systemic infection. 5. neoplastic infiltration of the skin at the site of pleural catheter insertion. 6. malignant pleural effusion with trapped lung or loculated pleural effusion. 7. previous lobectomy or pneumonectomy on the affected side. 8. karnofsky index score\> 50.
es catheter vs cryoablation after pectus surgery

Conditions: Pectus Excavatum

Summary: participants will be randomized to receive es catheter or cryoablation for pain management after the nuss procedure. the goal of this study is to compare the following between the two groups: * time to achieve short-term physical therapy goals and long-term functional outcomes * compare immediate and long-term postoperative opioid use * compare numbness on chest of postoperative day 1 and the return of sensation to baseline * compare the incidence of neuropathic pain and other complications participants will receive surveys for up to 12 months postoperatively.


Eligibility criteria:
inclusion criteria: * age 12 - 21 years * history of pectus excavatum * scheduled for nuss procedure exclusion criteria: * prior pectus repair * other concomitant surgeries * chronic pain conditions including ehlers danlos syndrome * non-english speaking - rationale: the questionnaires used in the study are in english language and the social and cultural factors of pain perception of non-english speaking patients could affect the study power * severe developmental delays including cognitive (difficulties understanding), motor (cerebral palsy or muscular dystrophy), and speech delays (difficulties communicating) * history of or active renal or liver disease * major surgery requiring opioids in the last 2 years * severe respiratory problems (such as obstructive sleep apnea, cystic fibrosis, pulmonary fibrosis, or pneumonia within the last month) * cardiac conditions including, but not limited to, cyanotic heart disease, hypoplastic left ventricle, arrhythmia, uncontrolled hypertension with ongoing treatment, kawasaki disease, or cardiomyopathies. participants with asymptomatic valvular lesions or defects may be included * bmi \>35 * pregnant or breastfeeding females
pro-power: hypertension with risk factors for a duration of 24 weeks with micardis 80mg/micardis plus 80mg/12.5mg

Conditions: Hypertension

Summary: pro-power is an observational cohort study for a period of 24 weeks. all recruited patients will have essential hypertension. in addition, the patients will have at least one other contributing risk factor for cardiovascular events. the study aims to evaluate the safety, efficacy and protection of micardis 80mg/micardis plus 80/12.5mg from cardiovascular risks in patients with essential hypertension


Eligibility criteria:
inclusion criteria: * male or female * aged 20 to 80 years old. * adult with essential hypertension - either newly diagnosed and untreated, or previously treated and uncontrolled * sitting blood pressure: systolic bp \> 140 mmhg but \ 90 mmhg but \< 110 mmhg) * at least one cardiovascular known risk factor other than hypertension: diabetes/hyperglycaemia, cholesterol /dyslipidemia, a previous cardiovascular event, target organ damage, family history of hypertension or cardiovascular diseases, old age defined as \> 55 years (males), \> 65 years (females), smoking, overweight or obese patients or a combination of above risk factors * patients who are assessed to benefit from the intake of angiotensin ii receptor blocker (arb) monotherapy or as add-on medication exclusion criteria: * patients with contraindications to telmisartan use (as per the micardis® tablets package insert). * known hypersensitivity to the active ingredient or to any of the excipients of micardis® . * any other clinical condition which, in the opinion of the attending physician, would not allow safe administration of the study medications. * patients participating in any other clinical trial. * patients already on micardis® alone or combination * pregnant females, or females breast feeding.
a six-month randomized controlled trial (rct) of probuphine safety and efficacy in opioid addiction

Conditions: Opioid Dependency

Summary: probuphine (buprenorphine implant) is an implant placed just below the skin containing buprenorphine (bpn). bpn is an approved treatment for opioid dependence. this study will confirm the efficacy of probuphine vs. placebo and compare probuphine treatment verses treatment with sublingual buprenorphine in the treatment of patients with opioid dependence.


Eligibility criteria:
inclusion criteria: * voluntarily provide written informed consent prior to the conduct of any study-related procedures * male or female, 18-65 years of age * meet dsm-iv-tr criteria for current opioid dependence * females of childbearing potential or a fertile male, must use a reliable means of contraception exclusion criteria: * current diagnosis of acquired immune deficiency syndrome (aids) * received any medication-assisted treatment for opioid dependence (e.g., methadone, bpn) within the previous 90 days * current diagnosis of chronic pain requiring opioids for treatment * candidates for short-term opioid treatment (\<6 months) only, or opioid detoxification therapy * pregnant or lactating female? * previous hypersensitivity or allergy to bpn, eva-containing substances, or naloxone * current use of agents metabolized through cytochrome p450 3a4 (cyp 3a4) such as azole antifungals (e.g., ketoconazole), macrolide antibiotics (e.g., erythromycin), or protease inhibitors (e.g., ritonavir, indinavir, and saquinavir) * history of coagulopathy within the past 90 days, and/or current anti-coagulant therapy such as warfarin * meet the dsm-iv-tr criteria for dependence on any other psychoactive substances other than opioids or nicotine (e.g., alcohol, sedatives) * significant medical or psychiatric symptoms, cognitive impairment, or other factors which in the opinion of the investigator would preclude compliance with the protocol, subject safety, adequate cooperation in the study, or obtaining informed consent * current medical conditions such as severe respiratory insufficiency that may prevent the subject from safely participating in study, or any pending legal action that could prohibit participation or compliance in the study * exposure to any investigational drug within the previous 8 weeks * previous exposure to probuphine, or prior implantation with a placebo implant in the context of a probuphine clinical trial * presence of aspartate aminotransferase (ast) levels greater than or equal to 3 x the upper limit of normal, alanine aminotransferase (alt) levels greater than or equal to 3 x the upper limit of normal, total bilirubin greater than or equal to 1.5 x the upper limit of normal, or creatinine greater than 1.5 x upper limit of normal on the screening laboratory assessments * clinically significant low platelet count on the screening laboratory assessments

Keywords: opioid dependence opioid addiction buprenorphine implant methadone heroin suboxone opioid pain medication opioid withdrawal
assessment of visual and refractive results and rotational stability of the tecnis® eyhance toric ii 1-piece posterior chamber lens in patients with astigmatism undergoing cataract surgery

Conditions: Cataract; Astigmatism

Summary: cataract surgery is one of the most common procedures performed worldwide. astigmatism is the most common refractive disorder in adults, hence there is a high prevalence of preexisting astigmatism in cataract patients. access to astigmatism correction during cataract surgery allows for improved visual outcomes for patients. toric intraocular lenses (iols) are the procedure of choice to correct corneal astigmatism of one diopter or more in cases undergoing cataract surgery. rotational stability is a key factor for successful outcomes with toric iols. postoperative toric iol misalignment is the major factor responsible for suboptimal visual outcomes after toric iol implantation. the tecnis® eyhance toric ii 1-piece posterior chamber lens is a new toric iol which is fda approved and ce marked. marketed by johnson \& johnson vision, it is indicated for the visual correction of aphakia and pre-existing corneal astigmatism of one diopter or greater in adult patients with or without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire reduction in residual refractive cylinder. no study assessing the early rotational stability of the tecnis® eyhance toric ii iol has been published yet.


Eligibility criteria:
inclusion criteria * aged ≥ 18 years * patients scheduled for bilateral cataract surgery * for at least one eye : * cataract surgery clinically indicated * corneal astigmatism ≥ 1 d * planned cataract surgery with placement of a tecnis® eyhance toric ii 1-piece posterior chamber lens non inclusion criteria * pregnant or breast-feeding women * in the eye with planned cataract surgery with placement of a tecnis® eyhance toric ii 1-piece posterior chamber lens: * irregular astigmatism (keratoconus suspicion) * corneal scaring in visual axis * retinal impairment that may limit visual recovery (macular degeneration, history of retinal detachment, etc.) * visually impaired eye since childhood that cannot be improved despite correction of the refractive disorder * any other ophthalmic disease inducing visual impairment

Keywords: tecnis® eyhance toric ii 1-piece posterior chamber lens