Kornimate/medical-research-clean huggingface dataset:
same day discharge

Conditions: Cardiac Arrhythmia

Summary: this study is to assess if subjects receiving a clinically indicated implanted cardiac pacemaker or defibrillator can be safely discharge home the same day of the procedure.

subjects who are implanted with a clinically indicated implanted cardiac pacemaker or defibrillator will be randomized to standard of care (next day discharge) versus same day discharge post implant. both groups will under go standard of care assessments prior to discharge. the same day discharge group will receive a phone call the next day to assess for events and will transmit device data electronically. both groups will be seen 10 - 14 days after implant for further evaluation. the subjects will also complete questionnaires regarding their knowledge of self care and satisfaction with care.

Eligibility criteria:
inclusion criteria: 1. scheduled for clinically indicated implant of cardiac pacemaker or defibrillator 2. willing and able to provide informed consent 3. appropriate clinical indication for the purpose of this study 1. primary prevention implantable cardioverter-defibrillator implant indicated for sudden cardiac death with ejection fraction more than 20% 2. sick sinus syndrome, non-high degree heart block as indication for pacemaker implant. 3. no history of syncope 4. no documented sudden cardiac death or ventricular arrhythmias requiring shock 4. adequate social support to be able to comply with protocol. 5. ability to complete remote monitor transmission exclusion criteria: 1. determined to be at risk for bleeding or on oral anticoagulation 2. planned to be implanted with non-biotronik device 3. complete heart block as indication for permanent pacemaker 4. secondary icd indication 5. immediate procedural complication requiring prolonged admission such as: pneumothorax, large hematoma, tamponade) determined during the procedure or immediately before discharge. -
clinical assessment of a new catheter surface coating with antimicrobial properties

Conditions: Renal Insufficiency

Summary: the study investigates the efficacy of a catheter with antibacterial surface coating in preventing central venous catheter related infection and the effect of an intensive hygiene and catheter care education of the nursing staff on preventing central venous catheter-related infection.

the risk of catheter-related bloodstream infection depends on catheter type, method and site of insertion, aseptic technique and number of manipulations. to address this problem, efforts have focused on engineering biomaterials and surfaces with antibacterial properties to prevent bacteria adhesion and biofilm formation. in view of the necessity to reduce catheter-related bloodstream infections and of the inadequacy of currently available antimicrobially coated devices, a new antimicrobial catheter surface was developed. among other factors, the mode and quality of catheter handling and care of exit site is an important aspect with respect to catheter-related infections. the clinical study aims at providing data on antimicrobial efficiency of the 2 types of ce certified double lumen catheters and a supposed additional preventive effect of intense hygiene training on catheter-related infections.

Eligibility criteria:
inclusion criteria: * central venous catheter placement * need for extracorporeal renal replacement therapy (acute and chronic renal failure) * age over 18 years * written informed consent * needed catheter length 15 cm or 20 cm exclusion criteria: * known infectivity with hepatitis b virus (hbv)/hepatitis c virus (hcv)/human immunodeficiency virus (hiv) * any infection associated with one or more positive blood cultures within 10 days prior to catheter implantation * bacteremia with a former catheter within 10 days prior to catheter implantation * known pregnancy * lactation * participation in another clinical study during the preceding 30 days

Keywords: renal dialysis dialysis, extracorporeal dialysis, renal extracorporeal dialysis
study of lumateperone in the treatment of patients with bipolar mania

Conditions: Bipolar Disorder, Manic

Summary: this is a multicenter, randomized, double-blind, placebo-controlled, study in the acute treatment of patients with a diagnosis of bipolar i disorder with manic episodes or manic episodes with mixed features (bipolar mania), with or without psychotic symptoms, according to criteria of the diagnostic and statistical manual of mental disorders, fifth edition (dsm 5).

the study will be conducted in 3 phases: * screening period (up to 1 week) during which patient eligibility will be assessed. * double-blind treatment period (3 weeks) during which all eligible patients will be randomized to receive lumateperone 42 mg or placebo in 1:1 ratio. * safety follow-up period (1 week) during which all patients will return to the clinic for a safety follow-up visit

Eligibility criteria:
inclusion criteria: 1. able to provide written informed consent before the initiation of any study specific procedures; 2. male or female inpatient, between the ages of 18 and 75 years, inclusive; 3. meets the diagnostic and statistical manual of mental disorders, 5th edition (dsm 5) criteria for bipolar i disorder with a current episode of mania or mania with mixed features with or without psychotic symptoms, as confirmed by a trained and sponsor-approved rater using the modified structured clinical interview for dsm-5, clinical trials version (scid-5-ct); 4. ymrs total score ≥ 20 and a score of at least 4 on two of the following ymrs items: irritability, speech, content, and disruptive/aggressive behavior at screening and baseline; 5. hospitalized voluntarily before screening or admitted to inpatient unit at visit 1 with a primary diagnosis of mania but not \> 14 days before screening. hospital admission must be a result of the current manic episode. exclusion criteria: 1. has a current primary dsm 5 psychiatric diagnosis other than bipolar disorder. these include: 1. schizophrenia, schizoaffective disorder, or other psychotic disorders; 2. dementia or other cognitive disorders; 3. intellectual disability; 4. moderate or severe substance use disorder (excluding for nicotine); 2. experiencing first manic episode; 3. in the opinion of the investigator, the patient has a significant risk for suicidal behavior during the course of his/her participation in the study or 1. at screening, the patient scores "yes" on items 4 or 5 in the suicidal ideation section of the columbia-suicide severity rating scale (c-ssrs) within 6 months prior to screening; or 2. at screening, the patient has had 1 or more suicidal attempts within 2 years prior to screening; or 3. at baseline, the patient scores "yes" on items 4 or 5 in the suicidal ideation section of the c-ssrs since the screening visit; or 4. at screening or baseline, scores ≥ 4 on item 10 (suicidal thoughts) on the rater administered montgomery-åsberg depression rating scale (madrs); or 5. considered to be an imminent danger to himself/herself or others.
androgen effects in hiv-infected women

Conditions: HIV Infection

Summary: androgen deficiency in hiv-infected women is associated with sarcopenia and may cause critical reductions in physical functioning and reduced bone density. the effects of long-term androgen therapy on lean body mass, bone density and other clinical endpoints including quality of life, functional status and neurocognitive function in hiv-infected women are not known.

we will perform an 18-month randomized, double-blinded, placebo-controlled study among relatively androgen deficient women with hiv, to determine the effects of testosterone administration on lean body mass. the administered dose will be 300 micrograms twice a week vs. identical placebo in the form of a transdermal preparation. secondary endpoints include effects on bone density, quality of life, neurocognitive function and menstrual function. open label administration at 300 micrograms twice a week will be initiated for 12 months in all subjects following the randomized portion of the study. assuming a 15% dropout rate and 25 randomized patients, the probability is 80 percent that the study will detect a treatment difference at a two sided 5.000 percent significance level, if the true difference between the treatments is 2.7 kg. this is based on the assumption that the standard deviation of the response variable, lean body mass by dexa, is 2.3 kg, as was shown by choi et al1 over 12 weeks in hiv-infected women at the same dose of 300 ug 2x/week.

Eligibility criteria:
inclusion criteria: * female 18 - 55 * bmi less than or equal to 26 * hiv-infected * androgen deficient, with free testosterone \< 3 pg/ml * stable antiretroviral regimen for 3 months prior to study * tubal ligation, hysterectomy, or verbalized understanding of appropriate barrier contraception methods. subjects will be counseled in appropriate barrier contraception methods and the counseling will be documented. exclusion criteria: * use of anabolic agent, including testosterone, gh or other preparations within 3 months of the study. * use of megestrol acetate within 3 months of the study * use of estrogen or any preparation known to affect bone density or bone turnover.this includes oral contraceptives, depo provera or combined progesterone-estrogen injections, and transdermal contraceptive patches. * pregnant or breast-feeding * hgb \< 9.0 mg/dl * current participation in another research study conducted by this investigator or past participation in the dhea study funded by the same grant as this protocol. * creatinine \> 1.5 mg/dl

Keywords: hiv women androgen treatment experienced
effectiveness of mhealth post-discharge intervention for patients with severe mental illness

Conditions: Bipolar Disorder; Major Depression; Schizophrenia

Summary: the overall aim of this program of research is to improve the continuity of care for patients with serious mental illness (smi) by supporting a safer and more efficient bridge from hospital to outpatient care using a mobile device-delivered app called transition-focus (tfocus), which has previously been tested in community samples. the purpose of the proposed project is to establish the effectiveness of our empirically-supported, multi-component mhealth intervention.


Eligibility criteria:
inclusion criteria: * psychiatric inpatient/partial hospitalization * diagnosis of schizophrenia-spectrum disorder or major mood disorder * planned ongoing mental health treatment post-discharge in the community * 18 years or older * ability to speak and read english exclusion criteria: * lack of smartphone * homelessness or housing instability that would prevent reliable follow-up * discharge to a long-term restricted living setting

Keywords: mhealth psychiatric hospitalization transitions of care
rapid assessment of esophageal adenocarcinoma risk test

Conditions: Barrett Esophagus; Esophageal Adenocarcinoma

Summary: this study aims to evaluate the acceptability of a new non-invasive screening device to test for barrett's esophagus. the investigators will prospectively enroll 100 patients to undergo cytosponge testing. the time of involvement for an individual will range from 2 weeks to 2 months, depending on the results of the cytosponge test and time to follow up endoscopy, if indicated.

the incidence of esophageal adenocarcinoma (eac) has risen over the past half century and continues to have a dismal prognosis. even though it has been established that barrett's esophagus (be) is the precursor lesion to eac, more than 90% of eac patients are never diagnosed with be beforehand. thus, the opportunity is missed to identify most patients at high risk for eac who could benefit from surveillance and early endoscopic therapy, which in turn may lower eac mortality. upper endoscopy is the only means to diagnose be, yet widespread endoscopic screening is impractical and expensive. there is an urgent need to develop minimally-invasive methods of be screening that can be easily performed in the primary care setting to allow for efficient and cost-effective interventions to decrease eac mortality.

Eligibility criteria:
inclusion criteria: males: ages 50-75 and at least one of the following: * gastro-esophageal reflux disease (gerd)\* or * family history (first degree relative) with barrett's esophagus or esophageal adenocarcinoma or * both body mass index (bmi) ≥30 or * a history of cigarette smoking (at least 10 pack years) females: ages 50-75 and gerd\* and at least one of the following: * family history (first degree relative) with barrett's esophagus or esophageal adenocarcinoma or * bmi ≥30 or * a history of cigarette smoking (at least 10 pack years) exclusion criteria: * history of gastric or esophageal cancer * history of esophageal surgery * known untreated esophageal stricture or uninvestigated dysphagia * previous upper endoscopy within 10 years * cancer within 3 years except for non-melanoma skin cancer * portal hypertension, with or without known varices * uncontrolled coagulopathy * uncontrolled major comorbid illness * inability to tolerate or contraindication to upper endoscopy * inability to give informed consent gerd defined as either a history of frequent heartburn or fluid regurgitation symptoms (at least weekly for 6 months) or regular use of proton pump inhibitors or histamine-2 receptor antagonists.

Keywords: cytosponge gerd
a long-term extension trial from late phase ii of spm 962 in advanced parkinson's disease patients

Conditions: Parkinson's Disease

Summary: the primary objective of this study is to investigate safety of spm 962 in advanced pd patients in a multi-center, open-label, non-controlled study following once-daily multiple transdermal doses of spm962 within a range of 4.5 to 36.0 mg (maximum treatment period: 54 weeks). efficacy is also to be exploratory investigated.


Eligibility criteria:
inclusion criteria: * subject completed the preceding trial 243-05-001. exclusion criteria: * subject discontinued from the preceding trial 243-05-001. * subject had a serious adverse event which association with the investigational drug was not ruled out during trial 243-05-001. * subject has a persistent serious adverse event at the baseline, which was observed and association with the investigational drug was ruled out during trial 243-05-001. * subject had persistent hallucination or delusion during trial 243-05-001. * subject has psychiatric conditions such as confusion, excitation, delirium, abnormal behaviour at the baseline. * subject has orthostatic hypotension at baseline. * subject has a history of epilepsy, convulsion etc. during trial 243-05-001. * subject has a complication of serious cardiac disorder. * subject has arrhythmia and need to be treated with class 1a antiarrhythmic drugs (e.g. quinidine, procainamide etc.) or class 3 antiarrhythmic drugs (e.g. amiodarone, sotalol etc.). * subject develops serious ecg abnormality at the baseline. * subject has qtc-interval \>= 500 msec at the baseline or subject has an increase of qtc-interval \>= 60 msec from the baseline in the trial 243-05-001 and has a qtc-interval \> 470 msec in female or \> 450 msec in male at the baseline. * subject had hypokalaemia in 243-05-001 study and not yet recovered. * subject has a total bilirubin \>= 3.0 mg/dl or ast(got) or alt(gpt) greater than 2.5 times of the upper limit of the reference range (or \>= 100 iu/l) at the end of the period in trial 243-05-001. * subject has bun \>= 25 mg/dl or serum creatinine \>= 2.0 mg/dl at the end of the taper period in trial 243-05-001. * subject has a history of allergic reaction to topical agents such as transdermal patch. subject showed serious or extensive application site reactions beyond the application site in the 243-05-001 study. * subject who plans pregnancy during the trial. * subject has dementia. * subject is unable to give consent. * subject is judged to be inappropriate for this trial by the investigator for the reasons other than above.

Keywords: spm 962 rotigotine parkinson's disease concomitant use of l-dopa
aqueous flare of a hydrophobic acrylic single-piece open-loop iol with modified material surface properties

Conditions: Cataract; Diabetes; Pseudoexfoliation Syndrome

Summary: modern phacoemulsification techniques have made cataract surgery safe and efficient over the past several decades. although the phacoemulsification procedure has improved greatly, cataract surgery still involves trauma. one of the surgical traumas during cataract surgery is the direct trauma of the anterior uvea, resulting in a later chronic immune reaction of the uvea to the implanted intraocular lens (iol). 1 the breakdown of the blood-aqueous barrier (a measure of the uveal reaction) clinically presents as flare in the anterior chamber. 2 petternel et al. 3 explained that the protein content of the aqueous humor may mainly arise from the iris root and iris vessels in the anterior chamber. the peak of this flare and cell intensity in the anterior chamber was shown to be reached during the first two days after cataract surgery 4 and flare levels were back to the preoperative values about one year after cataract surgery. 5, 6 influencing factors are surgical technique 7, perioperative treatment 8, iol biomaterial and design 9 and host reaction to the iol. in this study the otherwise same iol concerning material and design, but one with a new surface modification will be compared to assess the influence on aqueous flare and cell intensity in the anterior chamber. the polylens (polytech, rossdorf, germany) is a hydrophobic acrylic single-piece open-loop iol and is available with the standard surface and a novel modified surface. to assess the efficacy of the newly modified surface of the polylens iol compared to the same iol without a modified surface concerning flare and cell intensity in the anterior chamber as well as cellular components on the iol surface and lens epithelial out-growth from the rhexis after cataract surgery in eyes of patients with diabetes mellitus and pseudoexfoliation syndrome, which typically have a higher incidence of post-operative intra-ocular inflammation.


Eligibility criteria:
inclusion criteria: * bilateral age-related cataract * age 40 and older * diabetes mellitus or pseudoexfoliation syndrome exclusion criteria: * preceding ocular surgery or trauma
neonatal cord blood screening for hdn

Conditions: HDN - Hemolytic Disease of the Newborn

Summary: to evaluate the diagnostic efficiency of antibodies screening in cord blood for detection of hdn. to help finding the antigen negative blood in a timely manner and reduce the morbidities and mortalities of hdn

hemolytic disease of the newborn (hdn) refers to fetal or neonatal alloimmune hemolysis caused by red blood cell antibodies due to incompatible maternal and fetal or neonatal blood types. a french midwife first described the disorder in 1609; however, it was not until the 1950s when the underlying cause was clarified. the pathogenesis of hdn begins with the attack of fetal red blood cells (rbcs) by maternal antibodies due to incompatibility of maternal and fetal blood. immunologically, antibody secretion initially starts with immunoglobulin m (igm), which cannot cross the placental barrier, but is then followed by isotype switching, which produces immunoglobulin g (igg) antibodies. igg antibodies can cross the placental barrier, and they do so during the second and or subsequent pregnancies, attacking the fetal rbcs and causing hemolysis and associated complications such as hydrops fetalis and jaundice. hdn can occur due to rh antigens, most commonly the d antigen, and a,b and o rbcs antigens (abo) antigens. rh(d)-hdn has decreased since the introduction of antenatal and postpartum rh immunoglobulin. therefore, the prevalence of hdn, nowadays, varies according to blood type incompatibility. abo incompatibility is the most common cause of hdn and rh (d) antigen is the second most common cause.\[8\] rh (c, c, e, e) antigen incompatibility occurs occasionally. several other alloantibodies have also been reported to be associated with hemolytic diseases, including kidd, diego, duffy, kell and anti-mur. minor blood group incompatibility due to blood groups other than rh(d), although an uncommon cause of neonatal hyperbilirubinemia, has the potential to cause severe hyperbilirubinemia and its sequelae in infants, if left undiagnosed and untreated. therefore, identification of at-risk cases will help clinicians to reduce neonatal morbidity and will result in better patient management

Eligibility criteria:
inclusion criteria: * full term neonates \>/= 37 weeks. * abo blood compatible mother and neonate exclusion criteria: * preterm neonates \< 37 weeks. * abo incompatibility between mother and neonate
hypocaloric mediterranean diet or physical activity to lower cardiometabolic risk

Conditions: Overweight or Obesity; Obesity, Abdominal; Hypertension

Summary: the purpose of this randomized controlled trial is to test the effects of a hypocaloric mediterranean diet or of physical activity in participants who take at least 2 antihypertensive drugs but do not reach blood pressure treatment goal. this study is a randomized, controlled, single-center, parallel group trial with three arms: hypocaloric mediterranean diet (medi), physical activity (pa), or control. the control group will receive usual care (no intervention). this study will not be blinded. the interventions will last 6 months, while the study follow-up will last 12 months. four study visits will take place: baseline, at 3 months, at 6 months, at 12 months. the primary outcome is change in mean 24-hour ambulatory systolic blood pressure and diastolic blood pressure among groups after 6 months of intervention. secondary and exploratory outcomes include change in other measures of blood pressure, body composition, other markers of cardiometabolic disease, inflammation markers, safety outcomes, and quality of life, among others.


Eligibility criteria:
inclusion criteria: * men and women * 18 - 70 years * taking ≥ 2 antihypertensive drugs (includes combination therapy) * office sbp ≥ 140mmhg and/or dbp ≥ 90mmhg on two occasions * bmi 25 - 40 kg/m2 * waist circumference ≥ 88 cm (women) or ≥ 102 cm (men) * sedentary lifestyle (\< 150 minutes/week of moderate intensity physical activity) * weight stable (± 5 kg in the last 6 months) * not on a weight loss diet * willing to comply to an intervention of either a hypocaloric mediterranean diet or physical activity (or control) for 6 months exclusion criteria: * unable to provide informed consent * pregnant or lactating * office bp ≥ 160/100 mmhg * diabetes mellitus type 1 * history of cardiovascular disease (including uncompensated heart failure, recent infarction or stroke in the last 6 months, severe arrhythmia, heart failure or unstable angina pectoris) * chronic kidney disease stages 4 or 5 * cancer in the last 5 years * changes in concurrent medication (anti-hypertensives, anti-diabetics, lipid-lowering drugs) in the last 3 months * regular use of oral corticosteroids in excess of 5 mg prednisolone (or equivalent) during the last month * use of glp-1 analogues for \< 1 year * drug or alcohol abuse * eating disorders or severe dietary restrictions * impediments to physical activity at recommended levels due to musculoskeletal and other conditions.

Keywords: hypertension lifestyle mediterranean diet physical activity weight loss