Kornimate/medical-research-clean huggingface dataset:
an observational study of pegasys (peginterferon alfa-2a) in patients with hbeag-negative chronic hepatitis b (perseas)

Conditions: Hepatitis B, Chronic

Summary: this observational, multi-center, open-label study will evaluate the prognostic factors of long-term-response and the safety of pegasys (peginterferon alfa-2a) in patients with hbeag-negative chronic hepatitis b. data will be collected for 96 weeks.


Eligibility criteria:
inclusion criteria: * adult patients, \>/=18 years of age * diagnosis of hbeag-negative chronic hepatitis b with compensated hepatic disease, virus multiplication, raised alanine amino transferase results and/or fibrosis exclusion criteria: * co-infection with hepatitis a, c or d * co-infection with human immunodeficiency virus (hiv) * severe hepatic dysfunction or decompensated liver disease
clinical trial of diagnostic tests and clinical algorithms for dengue in febrile subjects in endemic areas in colombia

Conditions: Dengue

Summary: the present study aimed to develop a sensitive dengue diagnostic clinical algorithm using the resources that are available at the health care institutions, clinical expertise, and identification of signs and symptoms and variables of the hemogram associated with dengue. the performance of the potential algorithms were assessed under routine care. a single group cuasiexperimental study with a bayesian adaptive design was conducted. prior and cumulative information was used during intermediate analysis of clinical algorithms performance and according to these results algorithms were modified and then implemented in the subsequent study subjects. men and women of all ages, seeking care due to fever of less than 15 days were recruited in 3 endemic areas in colombia. the algorithms were applied by study physicians and blood samples taken for hemogram and dengue reference tests. it was planned that algorithms with high sensitivity (95%) and specificity (80%) were implemented in real life to assess their impact on patients outcomes alone and in combination with dengue rapid diagnostic tests but this was not feasible as not algorithms achieved the targetted performance. the experience of physicians using the algorithm in a mobile device was going to be explored with qualitative methods but this was explored with study physicians.


Eligibility criteria:
inclusion criteria: * fever of less than 15 days exclusion criteria: * origin of fever identified

Keywords: diagnostics sensitivity specificity clinical algorithm
the "self evaluation of food intake" (sefi) as a screening test for hospital malnutrition in children over 10 years

Conditions: Malnutrition, Child

Summary: the goal is to find a simple tool that can be used by medical and paramedical staff and that is reliable to identify children at risk for malnutrition.

the ingesta easy assessment score (sefi®) (formerly "food intake assessment tool or epa®") is validated in hospitals in adults to detect the risk of malnutrition and guide nutritional management. sefi® combines a visual analogue scale (vas) with a visual assessment of the portions consumed (www.sefi-nutrition.com). it comes in the form of a ruler equipped with a cursor and allows a visual assessment, by the patient himself, of his food intake, using an analog scale, or a choice of portions. consumed (see appendix). a score \<7/10 is associated with malnutrition or the risk of malnutrition. the investigators hypothesize that, in pediatric services for children 10 years of age or older, sefi® would be a feasible and reliable tool for screening for the risk of malnutrition.

Eligibility criteria:
inclusion criteria: * children aged 10 to 17 and hospitalized in pediatric or pediatric surgery, regardless of the reason for hospitalization. * whose holders of parental authority have received information on the protocol and have not expressed their opposition to the child's participation in the study, * having received information on the protocol and not having expressed opposition to participating in the study. exclusion criteria: * patients whose level of understanding does not allow the use of sefi®

Keywords: malnutrition children sefi
analysis of postural control of copd patients (attraction)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: chronic obstructive pulmonary disease (copd) is a common chronic respiratory disease, causing disabling respiratory symptoms and impairing patients' quality of life. currently one of the leading causes of death worldwide, copd is a major socio-economic concern. it is also accompanied by extremely frequent extra-respiratory manifestations (or co-morbidities). among these secondary manifestations, the equilibrium of these patients is subject to modifications: thus, numerous studies have shown that the equilibrium of copd patients was altered compared to healthy age-matched subjects. this alteration is associated with a greater functional limitation and a higher risk of falling. although this impairment has been demonstrated clinically, the balance of these patients has never been analysed using quantified movement analysis tools during tasks similar to those performed in daily life. moreover, the underlying mechanisms remain unknown and the possible associations with several clinical factors of interest (pain, dyspnea, muscle function...) have not yet been assessed. the hypotheses of this project are that (1) the postural control of copd patients is altered compared to healthy subjects during tasks of daily living and these changes can be characterised. (2) several clinical factors are associated with these changes.


Eligibility criteria:
inclusion criteria: * copd patients gold stage 2 and 3 (a-d) * in accordance with article l1121-8-1 of the public health code, participants must be affiliated to a social security scheme or benefit from such a scheme. exclusion criteria: 1. the presence of long-term or exercise-based oxygen therapy, 2. the presence of a medically diagnosed pathology causing manifest disorders of balance, 3. the inability to walk 150 m without stopping and to climb or descend stairs, 4. a history of pneumonectomy or lobectomy within the last six months, 5. the existence of an acute respiratory exacerbation within the last two months, 6. the presence of obvious cognitive impairment that impairs comprehension of instructions, 7. body mass index less than 21 or more than 35 kg/m². 8. person referred to in articles l. 1121-5 to l. 1121-8 and l. 1121-12 of the public health code: * pregnant woman, woman in labour or nursing mother * person deprived of liberty by judicial or administrative decision * person hospitalised without consent and not subject to a legal protection measure, and person admitted to a health or social establishment for purposes other than research * minor * person subject to a period of exclusion for other research * person of full age subject to a legal protection measure (guardianship, curatorship or safeguard of justice), person of full age unable to express their consent and not subject to a protection measure 9. person under psychiatric care

Keywords: chronic obstructive pulmonary disease postural balance activities of daily living
vascular health and risk factors in children with down syndrome

Conditions: Down Syndrome; Cardiovascular Risk Factor; Atherosclerosis

Summary: this is a prospective, multicenter, cross-sectional study to evaluate prevalence of vascular risk factors in children with down syndrome and to determine the association between vascular disease risk factors and objective markers of early atherosclerosis.


Eligibility criteria:
inclusion criteria: * all children with down syndrome (10.0-18.0 years of age) * children with translocations and mosaicism * children with and without chd exclusion criteria: * patients with a history of hypoplastic arch, coarctation or catheter or surgical based aorta interventions * patients who are currently treated or have been treated with chemotherapy for cancer or a myeloproliferative disorder within 1 year of the study * participants whose parent/legally authorized representative (lar) perceives the child is not able to cooperate with vascular imaging studies

Keywords: down syndrome cardiovascular risk factor atherosclerosis
dimini - diabetes mellitus? - not me!

Conditions: Health Behavior; Health Knowledge, Attitudes, Practice; Literacy; Diabetes Mellitus, Type 2; Diabetes

Summary: the increasing prevalence of type 2 diabetes mellitus is a worldwide problem. in preventing risk factors and unhealthy lifestyle through improved health literacy, chances are seen to delay or even avoid type 2 diabetes mellitus. the aim of the dimini-project is to prevent type 2 diabetes mellitus and to strengthen the health literacy of people at increased risk of developing it. for this purpose, people at increased risk are first identified by using the standardized screening tool finnish diabetes risk score (findrisc) adapted for germany. identified risk persons then receive a needs-based, modular lifestyle intervention including nutrition tips and physical exercises either paper- or app-based.

dimini, a randomised controlled trial, will assess whether the implementation of a lifestyle intervention for people at increased risk of developing type 2 diabetes mellitus will result in an improvement in body weight (primary outcome) and participants health literacy (secondary outcome) or not. a three-month intervention in the intervention group is followed by a one-year follow-up. the control group receives standard care as provided by the german statutory health insurance for three months and a one-year follow-up as well.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * resident in hesse or schleswig-holstein * statutory health insurance in one out of five participating health insurances * overweight/obesity * low physical activity * known family disposition for type 2 diabetes mellitus * history of increased glucose levels * findrisc results with scores ≥ 12 exclusion criteria: * age \< 18 years * resident outside hesse or schleswig-holstein * statutory or private health insurance with other than the participating health insurances * clinically manifested diabetes mellitus * malnutrition * psychiatric disorders * pregnancy * findrisc results with scores \<12 * participation in other clinical trials

Keywords: health literacy innovation fund lifestyle intervention risk screening type 2 diabetes mellitus diabetes mellitus, type 2
patient-centered research into outcomes stroke patients prefer and effectiveness research

Conditions: Stroke; Ischemic Stroke

Summary: prosper (patient-centered research into outcomes stroke patients prefer and effectiveness research) is a three year research project to create a national, sustainable model to improve decision-making and patient-centered stroke outcomes through comparative effectiveness research.

we propose to address existing evidence gaps and develop the requested data on the range of clinical outcomes that may be experienced by stroke survivors. to achieve these goals, we will link the nation's largest stroke registry, the american heart association (aha) get with the guidelines-stroke program and nationwide medicare claims data, coupled with telephone interviews for longitudinal treatment and downstream patient-reported outcomes. design \& procedures: retrospective: using gwtg-stroke database and its associated 1900 hospitals, we will conduct several comparative research protocols prioritized by stroke survivor focus groups and surveys. gwtg-stroke registry clinical data linked with medicare claims will be used for analysis of effectiveness and safety of post-stroke therapies on long-term clinical outcomes (n= 450,000). outcomes of interest include: "home-time" (days alive and at home) death stroke/tia readmission all-cause readmission cardiovascular readmission bleeding readmission prospective: we will use the existing avail registry combined with an additional 2000 stroke survivors for a combined cohort of over 5000 patients to obtain detailed information on patient-reported outcomes. the avail registry (irb # pro00012243) collected data from 3000 stroke survivors between 2006 and 2008. we plan to use these data to supplement our prospective prosper study. the prosper study will enroll a minimum of 2,000 subjects to augment the data collected from the avail study. consented patients from at least 75 sites will complete interviews at 3 and 6 months after discharge. we anticipate that the prosper questionnaire will include the following tools: fatigue severity scale (fss), patient health questionnaire (phq8), modified rankin scale (mrs), barthel index, euroqol (eq-5d), stroke-specific quality of life (ssqol-12) and lawton instrumental activities of daily living (iadl). sites will consent interested patients and have them complete a patient contact information form which includes, name, address, phone numbers, email address, etc. outcomes of interest include: : post-stroke fatigue, depression, chronic pain, medication intolerance, modified rankin scale (mrs), euroqol and stroke-specific quality of life.

Eligibility criteria:
inclusion criteria: * consistent with gwtg inclusion criteria, patients must be older than 18 and have a primary diagnosis of acute ischemic stroke. * ability to give informed consent or the availability of a surrogate who can consent on the patient's behalf. exclusion criteria: * patients with subarachnoid or intracerebral hemorrhage * patients with transient ischemic attack (tia) * patients with expected survival less than 6 months/discharged to hospice

Keywords: prosper stroke ischemic stroke
network analysis of adult mdd and adhd

Conditions: ADHD

Summary: the study is an investigation to determine co-morbid symptoms between adult major depressive disorder (mdd) and adult attention-deficit hyperactivity disorder (adhd) using a novel statistical technique called network analysis.


Eligibility criteria:
inclusion criteria: * participants have a diagnosis of mdd or adhd or both * participants are competent to consent to the study
interactive virtual telerehabilitation after total knee arthroplasty

Conditions: Knee Osteoarthritis

Summary: the purpose of this clinical trial is to compare the effectiveness of a new interactive virtual telerehabilitation (ivt) system with the conventional program in the rehabilitation of patients after total knee arthroplasty.

patients are distributed into two treatment groups: 1) group i (control): standard clinical protocol of tka rehabilitation consisting of 1-hour sessions for 10 days; and 2) group ii (ivt): 1-hour ivt sessions for 10 days (5 sessions under a therapist's supervision to verify the absence of medical complications + 5 sessions performed at home). the ivt is an interactive virtual software-hardware platform that facilitates the development of remote rehabilitation therapy for multiple diseases. patients receive information required to perform exercise and the therapist remotely monitors the patient's performance. for the purpose of this trial, the ivt system was designed for lower limb motor recovery in patients undergoing tka.

Eligibility criteria:
inclusion criteria: * post-tka active range of motion: flexion 80º and extension -10º * absence of stiffness * ability to walk with the use of a walking aid * ability to read and understand spanish * ability to understand and accept the trial procedures and to sign an informed consent form in accordance with national legislation exclusion criteria: * sensory, cognitive and/or praxic impairment * concomitant medical conditions that may influence the rehabilitation process * discharge destination other than home * patients with any local or systemic complication (e.g., surgical wound infection, suspicion of deep vein thrombosis...) in the three-month follow-up period

Keywords: knee osteoarthritis arthroplasty rehabilitation
unicentric comparing study of suction curettage with standard botox injection in the treatment of patients with essential axillar hyperhidrosis: comparing of efficacy, duration of effectiveness, and adverse events.

Conditions: Essential Axillary Hyperhidrosis

Summary: part 1: patients with essential hyperhidrosis are treated one time with suction curettage in both axillae. part 2: patients with axillary hyperhidrosis receive one treatment with suction curettage in one axilla, and at the same time one treatment with botox injections in the other axilla.


Eligibility criteria:
inclusion criteria: * 18 to 75 years * persistent bilateral primary axillary hyperhidrosis * hidrosis interferes with daily activities of patient * gravimetrically minimal 50 mg spontaneous sweat production in each axilla, measured during 5 minutes in room temperature in calm condition * signed informed consent * patient can and shall continue the trial until the end, and will follow the instructions correcly * women in reproductive period had a pregnancy test exclusion criteria: * medical condition that can be dangerous by treatment with botox, including myastenia gravis, lambert-eaton syndrome, als, and each other disease that can interfere with the neuromuscular function * secundary hyperhidrosis (for example secundary on hyperthyroid problems, lymfoma, malaria) * known allergy against study medication, his components, local anesthesia or iodium * use of aminoglycosids, curare-like products, or other products which can interfere with the neuromuscular function during the study * use of therapy for hyperhidrosis with aluminium chlorid during the study * infection or skin disease in the area to treat * participation in an other therapeutic study on the same time * botuline toxine treatment in the last 4 months * women who can or who want to become pregnant * women in reproductive period who don't use the appropriate contraception * patients in a situation of which the researchers decide it can be dangerous, or can interfere with the study
depression symptoms among ever married females attending primary health care units in dairut city

Conditions: Depressive Symptoms

Summary: depression is defined as a cluster of specific symptoms with associated impairment. the clinical and diagnostic features of the disorder are broadly similar in adolescents and adults. nevertheless, depression in adolescents is more often missed than it is in adults, possibly because of the prominence of irritability, mood reactivity, and fluctuating symptoms in adolescents. while depression is the leading cause of disability for both males and females, the burden of depression is 50% higher for females than males. in fact, depression is the leading cause of disease burden for women in both high-income and low- and middle-income countries.

the prevalence of depression in children is low (\<1% in most studies) with no sex differences, and then rises substantially throughout adolescence. okasha found that the lifetime prevalence of depression in urban and rural egyptian populations to be 11.4 and 19.7% several studies show that depression during adolescence is a risk factor of academic failures, marriage struggles, suicide attempts, interpersonal conflicts, unemployment, drug abuse; it is also a strong predictor of adulthood depression. girls married too early are also more likely to experience domestic violence, abuse and forced sexual relations. similarly early married females when interact with new individuals after marriage are unable to deal them psychologically which is mostly due to the bad behaviours shown from in-laws towards them thus leading to lower self-esteem, increasing their risk of clinical depression which on extreme aspect can cause suicidal attempts.

Eligibility criteria:
inclusion criteria: * married * divorced * separated * widow exclusion criteria: * cases diagnosed with mental disorders * history of mental disorders * family history of mental disorders
study of cgc-11047 when used in individual combinations with 1) gemcitabine or 2) docetaxel or 3) bevacizumab or 4) erlotinib or 5) cisplatin or 6) 5-flurouracil or 7) sunitinib in patients with advanced solid tumors or lymphoma

Conditions: Cancer

Summary: this study will aims to determine the maximum tolerated dose of cgc-11047 when used in individual combinations with gemcitabine, or docetaxel, or bevacizumab, or erlotinib or cisplatin or 5-flurouracil or sunitinib in one of 7 treatment arms. the dose of cgc-11047 will be escalated until the maximum tolerated dose is established.

this study will use a dose escalation design to determine the mtd of cgc-11047 when used in individual combinations with gemcitabine, or docetaxel, or bevacizumab, or erlotinib or cisplatin or 5-flurouracil or sunitinib in one of 7 treatment arms. the dose of cgc-11047 will be escalated in cohorts of 3 patients and dose escalation can proceed in each treatment group independent of dose escalation in the other treatment groups. cgc-11047 will be administered iv over 60 minutes and the doses of gemcitabine, docetaxel, bevacizumab, cisplatin, 5-flurouracil or sunitinib will remain fixed according to their respective product labeling.

Eligibility criteria:
inclusion criteria: * non-hematological advanced solid tumor malignancy or lymphoma where no curative therapy exists in which monotherapy with gemcitabine or docetaxel or bevacizumab or erlotinib or cisplatin, or 5-flurouracil or sunitinib would otherwise be warranted. * measurable disease based on radiographic evaluation or elevated tumor markers. * ecog - 0 or 1 (kps \>70). * life expectancy \> 3 months. exclusion criteria: * chemotherapy within 21 days or radiotherapy within 4 weeks prior to entering the study * known active brain metastases or leptomeningeal carcinomatosis. * history of a myocardial infarction within the prior 6 months or, hospitalizations for congestive heart failure within the prior 6 months, or active treatment for uncontrolled cardiac arrhythmias * clinically significant gastrointestinal tract hemorrhage, requiring transfusion therapy, within the prior 3 months.

Keywords: cancer advanced cancer solid tumors lymphoma cgc-11047