Kornimate/medical-research-clean huggingface dataset:
economic and clinical evaluation of enhanced recovery in colorectal surgery

Conditions: Colonic Diseases

Summary: the purpose of this study is to evaluate the health cost and clinical outcome by introducing enhanced recovery (eras) compared to conventional recovery in colorectal surgery.

aim of the sudy: 1. clinical evaluation: to investigate if patients treated with enhanced recovery have a shorter hospital stay and less morbidity than the patients treated conventionally. other clinical questions witch might be answered in this study are clinical surgical stress response (insulin resistent), amount of analgetics used and time to normal activity. 2. evaluation of quality of life: instruments used in this sudy to evaluate quality of life are 15 d and qualitative interview. 3. economic evaluation: cost-utility analysis of the clinical studies 4. compare patients who received a fast track program with dedicated fast track- and stoma nurse specialist and special focus on counselling and stoma education, compared with patients receiving existing current practice of stoma-education in a traditional care pathway, could reduce the length of hospital stay, readmission and stoma related complications 5. further we will tray to generate additional insights into the impact of counselling when groups of patients are otherwise equal in terms of fast-track criteria. we are therefore continuing the enrolling of our colorectal patients in which both study arms contain the same eras items; the arms will only differ in terms of perioperative information and guidance as well as follow-up by dedicated nurses.

Eligibility criteria:
inclusion criteria: * planed elective colorectal surgery, written consent and age above 18 years exclusion criteria: * patients below 18 years, pregnancy, surgical emergency and no informed consent

Keywords: colon rectum recovery surgery
metacognitive training program with depression

Conditions: Depression

Summary: the participants of this study have been diagnosed with mild to moderate depression with no evidence of suicidal actions prior to recruitment. all recruited subjects receive standard therapy and participate in a metacognitive training program (d-mkt) independently of study participation. diagnostic and therapeutical interventions are not part of this study. as part of this study, the change of cognitive and psychosocial achievement/behavior in patients with mild to moderate depression after taking part in the training program is being investigated. the training program seeks to enable group members to recognize and correct the often automatic and unconscious thought patterns that accompany depression, in part by viewing this depressive thought process at a distance (i.e., depersonalizing). in addition, dysfunctional assumptions about one's thought processes, as well as dysfunctional coping-strategies (i.e., thought suppression, rumination as problem-solving) are targeted (lena jelinek \& steffen moritz, http://clinical-neuropsychology.de/metacognitive_training_for_depression.html). within this study the cognitive and psychosocial behaviour changes are being investigated by neuropsychological assessment as well as questionnaires.


Eligibility criteria:
inclusion criteria: * participation in the metacognitive training program * subjects with an age over 55 years and a diagnosed mild to moderate depression without psychotic symptoms (f32, f33) * subjects have to be able to understand verbal and written information regarding treatment and procedures of the study. * subjects have to be able to understand and perform verbal and written tasks (cognitive tests/questionnaires). * no evidence of suicidal tendency exclusion criteria: * taking of medication or drugs that could influence cognition * diseases that prevent the subject from giving consent to this study or affect the collaboration during the examination * major and/or unstable physical diseases * strongly impaired vision/eye diseases * psychotic or manic symptoms * benzodiazepine addiction/dependency * suicidal tendency
evaluation of the role of connected scales in the therapeutic care of hematology patients

Conditions: Lymphoma, Non-Hodgkin; Myeloma Multiple

Summary: in this research, we will evaluate the feasibility of following by remote monitoring, using a connected scale, in hematology patients suffering from myeloma or lymphoma and requiring treatment with chemotherapy. 30 patients will be included in the research and will all use a connected scale for the duration of their participation (7 weeks +/- 1 week). during their participation, patients will be asked to weigh themselves once a day, ideally at a set time. patient data will be accessible by the medical team via a remote monitoring platform. alerts will be generated in the event of abnormal development of certain clinical parameters (weight, heart rate, etc.) allowing early treatment to be implemented by the medical team. at the end of their participation, we will evaluate patients' support and perception of this tool, as well as the healthcare consequences of the alerts generated by the remote monitoring platform.


Eligibility criteria:
inclusion criteria: * patient aged 18 and over (male or female) * patient suffering from aggressive non-hodgkin's lymphoma or multiple myeloma with a plan for systemic chemotherapy or having started two cycles or less or patient with the need for therapeutic intensification under the cover of autograft in the context of myeloma or lymphoma * patient who can be contacted by telephone during their participation in the research * patient able to return home at the end of their initial hospitalization * patient affiliated to social security * patient able to read and speak french * patient having signed free, informed and written consent exclusion criteria: * patient with an estimated life expectancy \< 3 months * patient with moderate to severe cognitive impairment (assessed by mmse \< 20) * patient with a psychiatric or physical disability that does not allow the use of the device * patient with a pacemaker * patient participating in another intervention research project * pregnant patient * patient deprived of liberty * patient under legal protection (guardianship or curatorship)

Keywords: hematology connected scale remote monitoring
effekt - efficacy and safety of long-term treatment with kogenate bayer/fs

Conditions: Hemophilia A

Summary: the aim of this international prospective, non-interventional post-marketing surveillance study is to obtain data on treatment procedures, long-term safety and efficacy and patient acceptance of kogenate bayer in treatment of patients with haemophilia a under daily-life treatment conditions.


Eligibility criteria:
inclusion criteria: * patients with diagnosis of haemophilia a, treated with kogenate bayer/fs as their only source of fviii, decision taken by the investigator to administer kogenate bayer/fs. for pretreated patients with more than 100 exposure days an inhibitor assessment within three months prior to enrollment should be available; for pretreated patients with less than 100 exposure days an inhibitor assessment at baseline should be available. exclusion criteria: * exclusion criteria must be read in conjunction with the local product information.

Keywords: octocog alfa haemophilia a
a study to evaluate sage-217 in participants with severe postpartum depression

Conditions: Postpartum Depression

Summary: the primary purpose of this study was to determine if treatment with sage-217 reduces depressive symptoms in participants with severe postpartum depression (ppd) compared to placebo as assessed by the change from baseline in the 17-item hamilton rating scale for depression (ham-d) total score at day 15 and to evaluate the safety and tolerability of sage-217 compared to placebo as assessed by the incidence of adverse events, vital sign measurements, clinical laboratory evaluations, electrocardiogram (ecg) parameters, and the columbia suicide severity rating scale (c-ssrs).

this study was previously posted by sage therapeutics. in november 2023, sponsorship of the trial was transferred to biogen.

Eligibility criteria:
key inclusion criteria: * participant either must have ceased lactating at screening or, if still lactating or actively breastfeeding at screening, must agree to temporarily cease giving breast milk to her infant(s) * participant has had a major depressive episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery, as diagnosed by the structured clinical interview for diagnostic and statistical manual of mental disorders (dsm)-5 axis i disorders (scid-i) * participant was \<=six months postpartum. key exclusion criteria: * active psychosis * attempted suicide associated with current episode of postpartum depression * medical history of seizures * medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder. note: suicidal ideation was not an exclusion. other protocol-defined inclusion/exclusion criteria might apply.

Keywords: postpartum care
a pivotal open-label trial of brentuximab vedotin for hodgkin lymphoma

Conditions: Disease, Hodgkin

Summary: this is a single-arm, open-label, multicenter, pivotal clinical trial to evaluate the efficacy and safety of brentuximab vedotin (sgn-35) as a single agent in patients with relapsed or refractory hodgkin lymphoma.


Eligibility criteria:
inclusion criteria: * patients with relapsed or refractory hodgkin lymphoma who have previously received autologous stem cell transplant. * histologically confirmed cd30-positive disease; tissue from the most recent post diagnostic biopsy of relapsed/refractory disease must be available for confirmation of cd30 expression via slides or tumor block. * fluorodeoxyglucose-avid disease by positron emission tomography and measurable disease of at least 1.5 cm as documented by spiral computed tomography. * at us sites patients greater than or equal to 12 years of age may be enrolled. at non-us sites patients must be greater than or equal to 18 years of age. exclusion criteria: * previous treatment with brentuximab vedotin. * previously received an allogeneic transplant. * congestive heart failure, class iii or iv, by the new york heart association criteria. * history of another primary malignancy that has not been in remission for at least 3 years. * known cerebral/meningeal disease.

Keywords: antigens, cd30 antibody-drug conjugate antibodies, monoclonal disease, hodgkin hematologic diseases lymphoma monomethylauristatin e drug therapy immunotherapy
augmented macular pigment-containing nutraceutical and central visual function

Conditions: Glaucoma; Glaucoma Eye; Glaucoma, Open-Angle

Summary: the purpose of this study is to prospectively analyze changes in macular pigment optical density and dermal carotenoid levels as they relate to visual field function in patients prescribed a macular pigment-containing medical food (lumega-z), in combination with a topical carbonic anhydrase inhibitor.

this is a prospective double-masked, randomized controlled trial which evaluates central visual field function as it relates to macular pigment optical density, contrast sensitivity, and dermal carotenoid levels in the presence of a commercial macular pigment-containing medical food (lumega-z). participants will be randomized to twelve weeks of supplement + dorzolamide or twelve weeks of placebo. all packaging of supplement and dorzolamide and the placebo will be identical and distributed by a third party. both subjects and the investigators examining patients will be masked to placebo and experimental group assignment.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * glaucoma diagnosis (h40. \*) with abnormal visual field as measured by 30-2 humphrey perimetry (mean deviation \< -2.00) * adequate iop control (iop \> 7 mmhg and \< 22 mmhg) by medical or surgical means measured by goldman applanation tonometry for at least 3 months * visual field progression - decrease (more negative) in md by 1.00 db or more when compared to prior hvf) * refractive error ≤ 10 diopters and astigmatism ≤ 3 diopters exclusion criteria: * bcva worse than 20/200 * pt is unable to tolerate mpod, cs, dermal carotenoid measurement-taking procedures * loss of iop control requires surgical intervention * patient already taking areds formula oral supplement * patient taking medication or dietary supplements that may interact with lm ingredients * history of photosensitive epilepsy * history of penetrating ocular trauma or vitrectomy * history of ocular or orbital radiation therapy or is currently receiving chemotherapy * women who are nursing, pregnant, or are planning pregnancy * has a known adverse reaction (including sulfa allergy) and/or sensitivity to the study supplement or its ingredients including: n-acetyl-cysteine, acetyl-l-carnitine, l-taurine, quercetin, co-enzyme q-10, lutein, meso zeaxanthin, zeaxanthin, astazanthin, lycopene, alpha-lipoic acid. * currently enrolled in an investigational drug study or has used an investigational drug within 30 days prior to recruitment. * is planning on having ocular surgery at any time throughout the study duration, or had ocular surgery \< 3 months before enrollment * native lens opacity ≥ grade 3 on arlns standard photograph * blue light filter intraocular lens

Keywords: lumega-z macular pigment macular pigment optical density contrast sensitivity humphrey visual field 10-2 dermal carotenoid mapcatsf veggie meter vector vision pericentral visual field
nafld in hiv-infected patients

Conditions: HIV-infection/Aids; NAFLD

Summary: the prevalence of nafld (nonalcoholic fatty liver disease) in hiv-infected patients is higher than that in general population, but the causes of morbidity and pathogenesis have not been fully explored. the investigators are planning to consecutively enroll 400 cases hiv-positive outpatients, and to detect nafld by ultrasound. the fecal and blood samples were also collected to explore the mechanism of nafld. the investigators aimed to determine the prevalence and risk factors of nafld in hiv infected patients.


Eligibility criteria:
inclusion criteria: * age 18\~70 y; * hiv-positive patients; * written the informed consent exclusion criteria: * coinfected with hbv, hcv; * secondary causes of fatty liver (eg, consumption of amiodarone and tamoxifen) and decompensated liver disease; * significant alcohol consumption (\>20 g per day for man, \>10 g per day for woman); * received antibiotics in preceding two months; * autoimmune disease; * severe heart, lung, kidney, brain, blood diseases or other important systemic diseases; * pregnant or lactating women

Keywords: hiv infection nafld
lipoprotein metabolism in normal volunteers and patients with abnormal levels of lipoproteins

Conditions: Healthy; Hyperlipoproteinemia

Summary: researchers plan to study the fat-rich particles, called lipoproteins, which circulate in the blood. this study is designed to improve understanding of normal, as well as abnormal, lipoprotein metabolism and the role it plays in the development of hardening of the arteries (atherosclerosis). patients participating in this study will receive an intravenous (directly into the vein) injection of a small amount of specially prepared amino acids. the amino acids being injected are the same amino acids present in a normal diet. the amount of amino acid given will be less than the amount eaten in a protein-rich meal. the amino acids will be labeled with nonradioactive heavy isotopes which are also present in the environment n low amounts. patients participating in the study will be required to have blood samples taken, and provide urine samples throughout the course of the study. in addition, patient will be required to follow a specially formulated diet. patients will be weighed throughout the course of the study.

apolipoproteins regulate the metabolism of lipids and lipoproteins in plasma of humans. in order to investigate the roles of apolipoproteins in these processes, we plan to quantitate the kinetics of the metabolism of apolipoproteins utilizing nonradioactive isotope labeled amino-acids.

Eligibility criteria:
the subjects for these investigations will be either healthy normal volunteer control subjects or patients who have a dyslipoproteinemia. subjects must be 18-80 years old.

Keywords: nonradioactive isotopes lipoprotein kinetics apolipoproteins dyslipoproteinemia healthy volunteers
sars-cov-2 (covid-19) and surgery

Conditions: Surgical Procedure, Unspecified

Summary: importance: during covid-19 pandemic, it is necessary to collect and analyze data concerning management of hospitals and wards in order to work out solutions for potential future crisis. objective: the objective of the study was to investigate how surgical wards in poland are managing during the covid-19 pandemic. design, setting and participants: an anonymous, online survey was designed and published on the official website of the association of polish surgeons. data was collected between march the 30th and april the 6th of 2020. after data analysis responders were divided into two groups: group 1 (responders currently working in a "covid-19-dedicated" hospital) and group 2 (responders currently working in "non-covid-19-dedicated" hospital). the study group included polish surgeons and surgery residents working in surgical departments during pandemic.

main outcomes and measures: descriptive data on perceptions of current status of surgical wards during the pandemic and impact of the pandemic on conducting surgery.

Eligibility criteria:
inclusion criteria: * the study group included polish surgeons and surgery residents working in surgical departments during pandemic, who granted an informed consent to participate in the study. . exclusion criteria: * retired surgeons, physicians and residents with non-surgical specializations, medical interns, medical students, other health-care professionals were excluded from this study
the bronx-valve registry

Conditions: Valvular Heart Disease

Summary: the bronx-valve registry is designed to collect and assess data on all patients with valvular diseases referred to montefiore medical center for echocardiographic exams. valvular heart disease (vhd) is a major focus of cardiovascular medicine, but limited data are available for racial and ethnic minorities. the aim was to assess the burden and clinical correlates of vhd in a highly diverse area of the united states.

cardiovascular disease is the leading cause of death in the general us population. although the burden of valvular heart disease is increasing due to a rapidly aging population, patients can benefit from improved and more accessible imaging modalities, and novel minimally invasive treatments. however, medical knowledge and technological developments might not be generalizable to all patient backgrounds due to lack of diversity in scientific literature. historically, clinical trials testing new treatment modalities have lacked equitable inclusion of people coming from racial/ethnic minority groups. similarly, epidemiological studies have focused on specific patient subsets with no direct comparisons with the other backgrounds. the bronx county (new york, usa) is considered by the us census as the most diverse area in the country, having the highest overwhelming concentration of non-white populations and being the only borough in all of new york city to be almost exclusively populated by non-white enclaves. these demographic characteristics make this county ideal to assess how the prevalence and the clinical correlates of valvular heart diseases might vary among diverse populations. on this background, the objective of this registry is to assess the burden of valvular heart diseases and explore their clinical correlates in the most diverse area of the united states.

Eligibility criteria:
inclusion criteria: * minimum age of 18 years old * undergoing transthoracic or transesophageal echocardiographic assessment at montefiore medical center or affiliated institutions in the bronx (ny, usa) exclusion criteria: * age below 18 years old * no available information regarding race or ethnicity

Keywords: valvular heart disease race ethnicity diversity mitral valve aortic valve tricuspid valve pulmonary valve stenosis regurgitation echocardiography
simple home-based exercise for knee osteoarthritis

Conditions: Osteoarthritis, Knee

Summary: 1. simple home-based standing balance training and isometric knee extension exercise for 4 weeks would improve functional ability and knee muscle strength of patients with knee osteoarthritis. 2. the outcome of standing balance training is different from isometric knee extension exercise.


Eligibility criteria:
inclusion criteria: * clinical criteria for knee osteoarthritis exclusion criteria: * cardiovascular disease * parkinsonism * osteoporosis * inability to walk for 15 meters * intra-articular injections

Keywords: osteoarthritis knee exercise balance
blood flow restriction therapy in achilles injury

Conditions: Achilles Injuries Tendon

Summary: blood flow restriction (bfr) therapy is a brief and partial restriction of venous outflow of an extremity during low load resistance exercises. it is a safe and effective method of improving strength in healthy and active individuals, recovering from orthopedic pathologies and procedures. this prospective, randomized study will look at the implications this form of treatment has on the rehabilitation of achilles injuries.


Eligibility criteria:
inclusion criteria: * diagnosed with achilles injury * must be at least 18 years of age and younger than 65 years of age * intention to receive physical therapy as standard of care exclusion criteria: * patients with intention to receive standard therapy and not the study therapy * patients with impaired circulation, peripheral vascular compromise, previous revascularization of the extremity, or severe hypertension * younger than 18 years of age or older than 65 * legally incompetent or mentally impaired (e.g. minors, alzheimer's subjects, dementia, etc.) * any patient considered a vulnerable subject