Kornimate/medical-research-clean huggingface dataset:
a study of two versus three daily injections in children and adolescents with newly diagnosed type 1 diabetes

Conditions: Diabetes Mellitus, Type 1

Summary: the optimal insulin regimen for children and adolescents with newly diagnosed type 1 diabetes remains unknown. the purpose of this study is to determine whether a split evening injection regimen (insulin injections before breakfast, supper and bedtime) leads to better glucose control and quality of life than twice daily insulin in children and adolescents with new onset diabetes.

the optimal insulin regimen for children and adolescents with newly diagnosed type 1 diabetes remains unknown. no published studies have examined the effectiveness of a split evening (three times daily) injection regimen in this group of patients. indeed, because the first few years of diabetes management are the easiest (due to a "honeymoon" period characterised by residual insulin secretion), the potential for any benefit from more intensive management (i.e., three daily injections) may be small during this period. in addition, the intensity of the initial insulin regimen may be an important determinant of quality of life, family functioning, and subsequent compliance with diabetes regimens. a randomized controlled trial has been designed to test the hypothesis that a split evening injection regimen leads to better glycemic control and quality of life than twice daily insulin in children and adolescents with new onset diabetes.

Eligibility criteria:
inclusion criteria: * new onset type 1 diabetes * less than 48 hours since first insulin injection * child and/or parent able to read and write english * family intends to continue treatment at our institution for the next two years * informed consent from adolescents greater than 16 years of age, or if less than 16 years, informed consent from the parent/guardian with assent from the child. exclusion criteria: * chronic medical conditions other than treated hypothyroidism or mild asthma * concerns of the diabetes team regarding future treatment adherence making twice daily insulin preferable to the split evening injection regimen (e.g., cognitive impairment, severe family dysfunction).

Keywords: diabetes mellitus, type 1 child adolescent disease management newly diagnosed hemoglobin a, glycosylated
efficay of extended peginterferon alpha 2a treatment in hbeag negative chronic hepatitis b patients

Conditions: Chronic Hepatitis B

Summary: the most important method to slow down and stop the liver disease progression in patients with chronic hepatitis b is antiviral therapy, by which to achieve maintaining viral response during treatment or obtain sustained viral response after treatment. the aim of the therapy with interferon is make patients obtain immune control to hbv defined as sustained viral response after treatment, however, most patients can't get this target after 48 weeks of interferon treatment, and some patients need extended treatment in clinical practice to enhance the rate of sustained viral response or hbsag loss occurred during treatment. in this cohort study, the efficacy of extended therapy of interferon in hbeag negative chronic hepatitis b patients will be evaluated.

in this cohort study, the hbeag negative chronic hepatitis b patients would be treated with peginterferon alpha 2a(peg-ifn a-2a) for 96 week and followed 24 weeks after treatment. serum hbv dna load, hbsag/anti-hbs level, hbeag/anti-hbe will be tested at enrollment and every 3 months during treatment and follow period. parameters of liver and kidney function, and liver ultrasound examination will be tested with intervals 1-3 months. the efficacies were evaluated by the rate of hbsag loss during treatment and the rate of sustained viral response after treatment and follow up.

Eligibility criteria:
inclusion criteria: * hbeag negative chronic hepatitis b patients exclusion criteria: * active consumption of alcohol and/or drugs * co-infection with human immunodeficiency virus, hepatitis c virus, or hepatitis d virus * history of autoimmune hepatitis * psychiatric disease * evidence of neoplastic diseases of the liver

Keywords: chronic hepatitis b interferon peginterferon hbsag loss
hematopoietic stem cells transplantation in children with combined immunodeficiency (cid)

Conditions: Combined Immunodeficiencies

Summary: the purpose of this study is to evaluate selective depletion of naïve cd45ra+ t cells from allogenic peripheral blood stem cell graft in children transplanted for combined immune deficiency. the aims of this procedure are to prevent graft versus host disease (gvhd) while preserving anti-infectious response from donor memory t lymphocytes.

combined immunodeficiencies (cids) are an heterogeneous group of primitive immunodeficiency (pid), which affect t cells development, function or both. these inherited conditions can only be cured by allogeneic hematopoietic stem cell transplantation (hsct). these procedures have a high risk of morbidity and mortality such a graft versus host disease (gvhd), rejection of the graft and serious infections, especially in this population of children with pid. gvhd is more frequent and severe if the donor is not an identical sibling and/or presents an hla-mismatch. gvhd requires high immunosuppression as prevention and treatment, and therefore impedes immunity against infections. in vitro and animal models suggest that gvhd is mediated by naïve t cells. the aim of this study is to decrease the rate and severity of gvhd after selective depletion of naïve cd45ra+ t cells from allogeneic hematopoietic stem cell grafts in patients with cids with high risk of severe gvhd, and to preserve immunity against pathogens in a population with high vulnerability to infections. the project aims is, first, to show improvement of rejection-free and gvh-free survival 12 months post-transplant, and secondly, to show the decrease of viral infection, and assess immune reconstitution kinetic and quality and specific antiviral responses, after a engraftment with naïve cell depleted allograft.

Eligibility criteria:
inclusion criteria: * patient from 12 months to 18 years * combined immunodeficiencies with known molecular diagnosis or if unknown, corresponding of p-cid study's definition * hematopoietic stem cell transplantation planned with one of the following donors : * sibling with 1 or 2 hla antigens mismatch * parent 10/10 or 9/10 identical * unrelated donor: 10/10 or 9/10 identical * consent form signed by the child's legal guardian * patient using effectiveness contraception during this trial * affiliated or beneficiary of a health insurance regimen exclusion criteria: * wiskott-aldrich syndrome * ongoing pregnancy * positive hiv pcr * contraindication for hematopoetic stem cell transplantation * geno-identical donor in the siblings * hematopoetic stem cell transplantation antecedent

Keywords: combined immunodeficiencies hematopoietic stem cell transplantation cd45ra primitive immunodeficiencies pediatric transplantation cd45ra depletion
audit of surgery for colorectal cancer

Conditions: Rectal Adenocarcinoma; Colon Adenocarcinoma

Summary: the aim of this project is to audit the surgical care in patients treated for colorectal adenocarcinoma. this study focused on collecting data from all consecutive cases of colon and rectal adenocarcinoma operated at the national institute of oncology in rabat during a two-years period. using standardized forms, the investigators collected data relating to each stage of treatment: pre-therapeutic, surgical and post-operative in order to measure the quality of the surgical care delivered. these results were compared to established benchmarks and to similar audit studies carried out in other countries around the world.

quality improvement initiatives and in particular the accreditation procedure raises the inevitable question of measuring quality in health. several surgical audits have been carried out internationally, showing the importance of collecting reliable and valid information on the quality of care. this approach allows an evaluation and improvement of the quality of care provided, significantly correlated to a direct impact on morbidity and mortality. in addition, it provides valuable information for evidence-based medicine research as it provides data on patients often excluded from therapeutic trials. colorectal cancer is the first digestive cancer and the third cancer worldwide. surgical resection is the main curative treatment. surgical quality is associated with better short and long term results. quality improvement measures, with the goal to improve surgical care of colorectal cancer, are becoming a standard worldwide. the aim of this project is to audit the surgical care in patients treated for colorectal adenocarcinoma. this study focused on collecting data from all consecutive cases of colon and rectal adenocarcinoma operated at the national institute of oncology in rabat. using standardized forms, the investigators collected data relating to each stage of treatment: pre-therapeutic, surgical and post-operative in order to measure the quality of the surgical care delivered. these results were compared to established benchmarks and to similar audit studies carried out in other countries around the world.

Eligibility criteria:
inclusion criteria: * patients with histologically proven colorectal adenocarcinoma who underwent surgical resection with curative intent between 1 january 2018 and 31 december 2019. exclusion criteria: * colon or rectal resections for other histologic types than adenocarcinoma. * palliative intent surgery.

Keywords: rectal neoplasms colon neoplasms
alk27-001: a study of trospium inhalation powder (trip)administered to subjects with copd

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: the purpose of this study was to evaluate the efficacy, safety, and tolerability of single doses of trospium inhalation powder (trip) administered to subjects with chronic obstructive pulmonary disease (copd).

this was a single-center, randomized, double-blind, cross-over, placebo-controlled study. following screening, each eligible subject was randomized to a dosing sequence. study subjects received a total of 5 single doses, each separated by a 3- to 14-day washout period. doses a, b, c, and d were administered in a double-blind fashion, in sequences generated by a 4-period latin square design. the 4 dosing sequences were: abcd, bdac, cadb, and dcba. dose e was administered in an open-label fashion as the final dose in each dosing sequence for all subjects. subjects reported to the clinic the evening prior to each dose. protocol assessments were carried out until 24 hours postdose. pulmonary function testing (via spirometry) was captured at specified timepoints at baseline as well as before and after dosing. other efficacy and safety outcomes were assessed according to protocol. blood sampling was performed for assessment of trospium concentrations at specified timepoints.

Eligibility criteria:
inclusion criteria: * male or female copd subjects between the ages of 40 and 80 years * body mass index between 18 and 35 * medically healthy (other than copd) * fev1/fvc less than or equal to 0.70 * current non-smoker or able to abstain from smoking for at least 8 hours postdose * within the previous 6 months, demonstrated improvement in fev1 (greater than or equal to 10%) 1 hour following administration of ipratropium bromide inhalation (4 puffs) * females of childbearing potential must agree to use an acceptable method of contraception for the duration of the study exclusion criteria: * asthma in the last 10 years * allergic rhinitis, atopy, cystic fibrosis, bronchiectasis, or tuberculosis * bladder neck obstruction, including urinary retention or known symptomatic prostatic hypertrophy not controlled with medication * narrow angle glaucoma * tachyarrhythmia * alcohol dependence or illicit drug abuse within the past year * using long-term oxygen therapy * female subjects who are pregnant or breastfeeding * participating in another clinical trial

Keywords: copd pulmonary inhalation
coventry outcomes study of seniors (coss): a comparative effectiveness study to evaluate the effect of a multidisciplinary team's intervention on the incidence of nonelective hospitalizations in a medicare population

Conditions: Heart Failure; Chronic Obstructive Pulmonary Disease; Cardiovascular Disease; Diabetes; Osteoporosis

Summary: the investigators are studying the impact of the interventions of a multidisciplinary team (mdt) - consisting of a coventry case manager, social worker, and medical director, alongside a medco specialist pharmacist - on the hospitalization rates of high risk seniors with chronic conditions, compared with a usual care approach. the study will also examine the impact on quality of life, medication adherence, medical costs, hospital readmission rates, and a variety of other important measures. the outcome of coss may support a means to further enhance and develop a comprehensive care model program by leveraging the partnership between a health plan and a pharmacy benefit manager.

the multidisciplinary team will provide face-to-face visits in a home setting with interventions that focus on five key areas: care transitions, self-management, care coordination, pharmacy and prevention, all designed to support high-risk medicare members and their relationship with their primary care providers. if the study proves to reduce hospitalizations in the senior population, it could provide important guidance for future efforts to reduce the cost and improve the quality of care for seniors with chronic conditions.

Eligibility criteria:
inclusion criteria: * inouye risk score \>3 calculated on coventry claims * medicare advantage beneficiaries age \> 65 years * continuous eligibility \> 12 months prior to study * ability to be contacted via telephone * subject is willing and able to provide informed consent * willing to comply with all study procedures and be available for the duration of the study exclusion criteria: * active cancer treatment (i.e. chemotherapy or radiation) in the past 6 months * living anywhere other than a community setting \[i.e. skilled nursing facility (snf)\] * just-in-time (jit) members * members with a geographic location \> 60 from either st. louis or kansas city, mo. * solid organ transplant recipients * active enrollment in another clinical research study
an observational study examining the effect of added mabthera therapy in patients with untreated chronic lymphocytic leukemia

Conditions: Chronic Lymphocytic Leukemia

Summary: this study will examine the effectiveness of mabthera therapy added to a standard chemotherapy regimen for the treatment of previously untreated chronic lymphocytic leukemia (cll). patients who have received a single prior mabthera plus chemotherapy treatment are eligible. the overall response rate of patients treated for approximately 5 months (as per current label guidelines) will be analysed according to various factors (i.e., age, concurrent treatment, and chromosomal abnormalities).


Eligibility criteria:
inclusion criteria: * diagnosed with first-line cll having received only 1 cycle of mabthera chemotherapy * aged \>/= 18 years exclusion criteria: * pregnant or breast-feeding * receipt of an investigational drug within 30 days prior to entering the study
delta q value to discriminate detrusor underactivity from bladder outlet obstruction

Conditions: Urinary Obstruction; Detrusor Underactivity

Summary: to determine the significance of delta q value (qmax - qave) in discrimination between boo and du, to avoid invasive studies (pressure flow studies (pfss)) and replace them with noninvasive study (uroflowmetry).

lower urinary tract symptoms (luts) in old male patients are usually secondary to prostatic hyperplasia. however, it is becoming clear nowadays that prostatic enlargement is not always the cause of male luts, and other factors could cause male luts in the presence of benign prostate enlargement (bpe). two clinical situations are common in elderly patients like bladder outlet obstruction (boo) and detrusor underactivity (du) they affect the voiding phase in elderly men markedly. to distinguish one from another may be challenging and could be only done by urodynamic study (uds), which is the gold standard for diagnosis. a urodynamic study is an invasive procedure, with side effects of pain and urinary tract infection, and the need for special equipment and expertise has limited its widespread use and made it very stressful for the patients. on the other hand, uroflowmetry is a non-invasive procedure that could be used in patients' assessments. a term of delta q is being used that focuses on the difference between (qmax) and (q-average). the hypothesis is that delta q would be lower in detrusor underactivity because of the undermined detrusor function decreasing both average and maximum urine flow rate, but it is higher in boo, which has normal detrusor contraction during the voiding phase. based on the concept uroflow can be used to replace urodynamic studies to differentiate between these 2 entities and hence to determine the proper management plan and to be a prognostic factor before surgical intervention.

Eligibility criteria:
inclusion criteria: * male patients aged over 50 years complaining of voiding symptoms * international prostatic symptom score (ipss) 8 points or more, * serum prostate-specific antigen (psa) below 4 ng/ml * no hematuria or pyuria. exclusion criteria: * patients who were unable to complete the voiding study were deemed not eligible to participate in this review. * patients with neurological causes of voiding dysfunction * history of urinary tract abnormalities/lithiasis, lower urinary tract surgeries, urinary tract malignancy. * acute uti were excluded.
a study to evaluate the safety and immunogenicity of ad5-vector based vaccine against coronavirus variants in adults (≥18 years) immunized with 2 doses of mrna vaccines plus one dose of booster azd1222 vaccine

Conditions: COVID-19

Summary: subjects who have completed the primary mrna vaccine immunizations and the 1st booster azd1222 immunization for more than 6 months will be randomized to receive a 2nd booster dose of ad5-ncov/o, ad5-ncov/o-ih or mrna-based covid-19 vaccine in a ratio of 2:2:1.

this is a multicenter, randomized, observer-blind, and parallel-controlled clinical study to evaluate the immune responses and safety profiles in adults (≥ 18 years) receiving investigational products (intramuscular injection or nebulized inhalation) ≥ 180 days after the immunization of 2 doses of bnt162b2 vaccines plus one dose of booster azd1222 vaccine. this study will enroll about 30% participants aged 60 years and above. subjects who have completed the primary mrna vaccine immunizations and the 1st booster azd1222 immunization for more than 6 months will be randomized to receive a 2nd booster dose of ad5-ncov/o, ad5-ncov/o-ih or mrna-based covid-19 vaccine in a ratio of 2:2:1.

Eligibility criteria:
inclusion criteria: 1. participants aged 18 years and above at the time of screening. 2. received the 1st booster vaccination at least 180 days earlier. 3. agree to attend all visits and sign the written informed consent form. exclusion criteria: 1. have a history of seizures, epilepsy, encephalopathy, psychosis. 2. history of severe anaphylaxis or allergy to any vaccine component. 3. positive urine pregnancy test result, pregnant, lactating women. 4. medical history of guillain-barré syndrome. 5. have had asthma attacks within 2 years. 6. have severe nasal or oral diseases, such as rhinitis (sinusitis), allergic rhinitis, oral ulcer, throat swelling, etc. 7. bleeding disorder (e.g. protein s or factor deficiency, coagulopathy or platelet disorder). 8. have chronic systematic infection or chronic obstructive pulmonary disease (copd), etc. 9. administration of immunoglobulins and/or any blood products within three months prior to the planned administration of the vaccine candidate. 10. current diagnosis or receiving treatment for tuberculosis or cancer. 11. history of sars-cov-2 infection for less than 3 months. 12. received or plan to receive any vaccines (licensed or investigational), within 14 days before and after study vaccination. 13. have an axillary temperature of \> 37.0℃. 14. any other significant diseases, disorders or findings which may significantly increase the risk to the volunteer because of participation in the study, and affect the ability of the volunteer to participate in the study or impair interpretation of the study data.
palliative, rehabilitation, and integrated medicine handbook for self care at work

Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Summary: this study investigates the usefulness of the self care at work handbook in order to generate an improved version. information from this study may help researchers identify potential factors associated with perception and usefulness of the self care at work handbook.

primary objectives: i. to explore the global perception of the perceived usefulness of the handbook, and the frequency that the handbook is consulted. ii. to explore the perceived usefulness of and adherence to each individual item of the handbook. iii. to solicit personnel for their ideas about the handbook, and particularly any additional handbook items they might suggest. iv. to explore any relationships between the actual use or the perceived importance of each handbook item with respondents' self-reported professional satisfaction. v. to explore any associations between responses to handbook items and professional, demographic, and work satisfaction characteristics before and during the coronavirus disease 2019 (covid-19) crisis. vi. to explore respondents' global perceptions of the usefulness and adherence to the handbook before and during the covid-19 crisis. outline: participants complete a survey over 20 minutes.

Eligibility criteria:
inclusion criteria: * clinicians in the department of palliative, rehabilitation, and integrative medicine. this includes physicians, advanced practice providers (apps), and other clinical staff in the supportive care center and acute palliative care unit exclusion criteria: no
heart and blood pressure study: the effect of aortic impedance on myocardial relaxation

Conditions: High Blood Pressure

Summary: does dilation of blood vessels (vasodilation), which decreases aortic stiffness, have a greater effect on heart myocardium relaxation (diastole) than vasodilation which affects mean pressure equally without improving aortic stiffness?

60 subjects, 30 with hypertension and 30 without will attend two visits to the gcrc. at each visit, pulsatile hemodynamics (by using tonometry-a non-invasive means to obtain arterial pressure tracings) and doppler tissue imaging relaxation velocity (a measurement of myocardial relaxation obtained by echocardiography) data will be collected before and after administration of vasodilator medication. at the first visit, each patient will receive an oral dose of the vasodilator hydralazine (does not effect aortic stiffness), and at the second visit each patient will receive intravenous nesiritide (does effect aortic stiffness). the relationship between timing of the reflected pulse wave and myocardial relaxation velocity will be studied at baseline and following administration of each vasodilator to determine if changing aortic stiffness has an impact on myocardial relaxation.

Eligibility criteria:
inclusion criteria: * subjects over the age of 65 exclusion criteria: * have known or suspected coronary artery disease * have known or suspected left ventricular dysfunction * have significant valvular, infiltrative, pericardial, or congenital heart disease * have a resting systolic blood pressure \< 100 mmhg * have had an adverse reaction to nesiritide or hydralazine * have a serum creatinine \> 2 mg/dl at visit 1

Keywords: arterial stiffness echocardiography nesiritide