Kornimate/medical-research-clean huggingface dataset:
study of renal blood flow during human endotoxemia

Conditions: Healthy; Type 2 Diabetes; Endotoxemia

Summary: the purpose of the present protocol is to study whether endotoxemia will affect the renal blood flow in type 2 diabetics and healthy volunteers.

many septic patients develop acute renal failure and the risk is higher in patients with diabetes. the pathogenetic mechanisms behind the development of acute renal failure in connection with sepsis is not completely understood. one among many possible explanations is a change in renal hemodynamics. however, it is still largely unknown what happens to the renal plasma flow during human sepsis. in this study we give endotoxin injection (0,3 ng/kg) to type 2 diabetics and healthy controls as an experimental model of sepsis. renal plasma flow and glomerular filtration rate are measured by dtpa-renography 1 day before before and 1,25 and 6,5 hours after injection of endotoxin. furthermore wbc, plasma-cytokines,vcam-1/icam-1, endothelin-1, thromboxane b2, angiotensin 2, renin and pai-1 are measured on an hourly basis up to 8 hours after endotoxin injection.

Eligibility criteria:
inclusion criteria: * healthy * type 2 diabetes exclusion criteria: * renal failure * heart failure * lung disease

Keywords: renal plasma flow endotoxemia type 2 diabetes
safety and efficacy trial of recombinant human granulocyte colony stimulating factor (gcsf)

Conditions: Chemotherapy-Induced Neutropenia

Summary: a phase iii randomized controlled open label comparative multicentric trial to compare the safety and efficacy of indigenous recombinant human granulocyte colony stimulating factor (rhg-csf) with neupogen in patients on myelosuppressive therapy for non myeloid malignancies. adult patients (18 years of age or older) diagnosed as having any malignancy (except myeloid malignancy, ecog status of 0-2 and having a history of experiencing neutropenia (absolute neutrophil count \< 1000/mm3) in a previous chemotherapy cycle and have one more cycle of chemotherapy on the same drugs would be recruited into the study. treatment will be initiated not earlier than 24 hours after the administration of cytotoxic chemotherapy in both groups. group 1: recombinant human granulocyte colony stimulating factor (rhg-csf)(shantha) * dose: 300 mcg/day administered subcutaneous/intravenous/continuous subcutaneous infusion for a minimum of 7 days and for a maximum of 14 days or till neutrophil count of 10,000/mm3 is reached whichever is earlier group 2: neupogen (rhg-csf) * dose: 300mcg/day administered subcutaneous/intravenous/continuous subcutaneous infusion for a minimum of 7 days and for a maximum of 14 days or till neutrophil count of 10,000/mm3 is reached whichever is earlier primary end point would be to evaluate the percentage of patients developing febrile neutropenia (defined as body temperature ≥ 38.2°c or developing a temperature of \> 38°c twice in a 12-hour period and absolute neutrophil count \< 0.5 x 109/l on the same day of the fever or the day after)in the two treatment groups.


Eligibility criteria:
inclusion criteria: * patients of either sex aged 18 yrs or more * patients diagnosed having any malignancy (except myeloid malignancies and myelodysplastic syndromes) receiving standard combination chemotherapy. * patients experiencing neutropenia (absolute neutrophil count \< 1000/mm3) in a previous chemotherapy cycle and have one more cycle of chemotherapy on the same drugs. * patients should have performance status of 0-2 ecog (european cooperative oncology group). exclusion criteria: * patients unwilling to give informed consent or unable to follow study procedures * patients requiring autologous or allogenic stem cell transplantation. * patients having active infection * patients who have taken antibiotics or colony stimulation factor within the previous 10 days * patients who have clinically significant uncontrolled medical illness except malignancy * patients having renal impairment (serum creatinine \> 1.5 times the upper normal limit) and abnormal liver function (bilirubin \> 5 times the upper limit of normal) * pregnant or lactating women * patients who have involvement of bone marrow * patients receiving simultaneous radiotherapy
a study to evaluate efficacy and long-term safety of oral ozanimod in chinese participants with moderately to severely active ulcerative colitis (uc)

Conditions: Ulcerative Colitis

Summary: the purpose of this study is to evaluate the efficacy and safety of ozanimod compared with placebo in participants with ulcerative colitis (uc) in mainland china and taiwan. the main study is composed of an induction period, maintenance period, safety follow-up, and participants meeting certain criteria will be given the opportunity to participate in an optional open label extension.


Eligibility criteria:
inclusion criteria: main study: * eligible participants must be chinese. * participant has had moderately to severely active uc diagnosed at least 3 months prior to first investigational product administration. open-label extension period: * participants who have completed the week 10 visit and are non-responders at week 10. * participants who have completed the induction period and entered the maintenance period experienced disease relapse during the maintenance period, or who have completed the maintenance period at week 52. exclusion criteria: main study and open-label extension period: * participant has severe extensive colitis, diagnosis of cd, indeterminate colitis, presence or history of a fistula consistent with cd, microscopic colitis, radiation colitis, or ischemic colitis. open-label extension period: * participant has clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, psychiatric, or other major systemic disease making implementation of the protocol or interpretation of the study difficult or that would put the participant at risk by continuing the study or that would have required a participant to discontinue treatment were observed during the induction period or maintenance period. * participant has clinically relevant cardiovascular conditions, including history or presence of recent myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, class iii/iv heart failure, sick sinus syndrome, or severe untreated sleep apnea were observed during the induction period or maintenance period.
expanded access to everolimus, for an individual patient with uterine sarcoma (ctms#18-0020)

Conditions: Uterine Sarcoma

Summary: single patient treatment with everolimus.


Eligibility criteria:
prostate volume changes following prostate brachytherapy with iodine-125 seeds

Conditions: Prostate Cancer

Summary: the size of the prostate changes due to insertion of the radioactive seeds. we will measure the prostate size, before and after the procedure.

the prostate size will be measured using the trus and ct scan on days -1, 0, 1, 9, 30, and 60 days after the brachytherapy procedure.

Eligibility criteria:
inclusion criteria: * pathologically confirmed diagnosis of prostate cancer * t1-3 disease * psa \<20 ng/ml * patient must sign a study-specific informed consent prior to enrollment. exclusion criteria: * patients ineligible to brachytherapy

Keywords: brachytherapy prostate volume
shock wave and core exercises for postpartum sacroiliac pain

Conditions: Postpartum Sacroiliac Joint Pain

Summary: despite the high popularity and novelty of shock wave therapy (swt), it is surprising that just one study has examined the effect of swt on patients with sijd and their functional ability following treatment by using subjective assessment tools like numeric rating scale (nrs) and limited by its small sample size and lack of long-term follow-up. therefore, the present study is expected to contribute to the body of knowledge by exploring the effect of adding swt to core stability exercises in the management of postpartum sacroiliac joint pain.


Eligibility criteria:
inclusion criteria: * post-partum women diagnosed with sijp with limitation of its movement referred from the orthopedist. * age is between 25-35 years old. * their body mass index will be ranged from 25-35 kg/m2. exclusion criteria: patients who have one of the following criteria will be excluded from the study: * previous spinal surgery. * medical diagnosis other than sij dysfunction. * patients who had any other spine disorders. * patients who had leg length discrepancies. * patients with congenital postural deformities. * patients with spinal cord injury or acute or unstable neurological signs. * patients with cauda equina symptoms related to the spine including changes in bowel or bladder control and perineal sensation. * patients with lumber intervertebral disc, spondylosis, lumbar canal stenosis and spondylolysthesis.
phase iii randomized study of synsorb pk in children with e. coli-associated hemolytic uremic syndrome

Conditions: Hemolytic Uremic Syndrome

Summary: objectives: i. determine the effect of synsorb pk therapy on mortality and frequency of severe extrarenal complications observed in children with acute stage e. coli-associated hemolytic uremic syndrome. ii. determine the effect of synsorb pk therapy on the need for the duration of dialysis in these patients. iii. determine the effect of synsorb pk therapy on the recovery of renal function and resolution of urinary abnormalities in these patients.

protocol outline: this is a randomized, double blind, placebo controlled, multicenter study. patients are randomized to receive either synsorb pk or placebo. patients receive oral synsorb pk or placebo three times daily for 7 days. patients are followed on days 7, 14, 28, and 60 after discharge from the hospital.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- * clinically diagnosed e. coli-associated diarrhea-associated hemolytic uremic syndrome (hus) * diarrheal prodrome within 7 days before onset of disease * no hus associated with the following: hereditary post-bone marrow transplantation streptococcus pneumoniae infection * no prior catastrophic complications --patient characteristics-- * hematopoietic: thrombocytopenia less than 140,000/mm3 fragmented red blood cells * renal: renal involvement (hematuria, proteinuria, or azotemia) no underlying glomerular disease * other: hiv negative no pre-existing structural abnormality or dysmotility syndrome of the gastrointestinal tract no inflammatory bowel disease (e.g., crohn's disease, ulcerative colitis)

Keywords: e. coli infection bacterial infection hemolytic uremic syndrome immunologic disorders and infectious disorders rare disease renal and genitourinary disorders
mother buddy program

Conditions: Physical Activity; Obesity

Summary: the purpose of the 12-week study is to determine if competing a physical activity program with a buddy helps increase daily physical activity when compared to completing the same physical activity program without a buddy.


Eligibility criteria:
inclusion criteria: 1. physically inactive, 2. having at least one child aged less than 5 years, 3. having at least one family member or friend who can support physical activity engagement and reside in the same community, 4. having access to computer and phone, and 5. overweight/obese (body mass index: 23 kg/m2 or more) exclusion criteria: 1. having known medical conditions that prevent regular physical activity and 2. current participation in other lifestyle modification programs
robot-assisted vs laparoscopic radical prostatectomy for prostate cancer treatment

Conditions: Prostate Cancer

Summary: this study is to compare the outcomes of robotic-assisted laparoscopic radical prostatectomy (rarp) and laparoscopic radical prostatectomy (lrp) for prostate cancer treatment in terms of perioperative surgical, functional and oncological outcomes.

participants will either have robotic-assisted laparoscopic radical prostatectomy (rarp) or laparoscopic radical prostatectomy (lrp) as determined by the treating surgeon. all participants will undergo tests and questionnaires to determine urinary and erectile function, biopsies to determine perioperative surgical, functional and oncological outcomes. these assessments will be conducted pre-operatively, post-operatively and at certain follow-up time points up to 12 months.

Eligibility criteria:
inclusion criteria: 1. adult men aged 18 years and over; 2. undergoing rarp or lrp. prostatectomy for prostate cancer at binh dan hospital; 3. clinically suitable for radical prostatectomy (ct1-3, no, mo); 4. cognitively able to give written informed consent for participation; 5. elective procedure. exclusion criteria: 1. the patient lacks the ability to consent for themselves; 2. patients unwilling to undergo pre- and post-operative evaluation according to the protocol;

Keywords: laparoscopic radical prostatectomy robotic-assisted laparoscopic radical prostatectomy prostate cancer
a nurse-led coaching programme with telemonitoring in heart failure

Conditions: Heart Failure; Telemonitoring; Hospitalizations; Feasibility; Mentoring

Summary: the goal of this pilot interventional study is to assess the feasibility and acceptability of a supportive intervention for patients affected by heart failure. the main questions it aims to answer are: * are implementation strategies effective in facilitating participant fidelity? * what factors contribute to patients' satisfaction with the designed intervention, and how can these be optimized for improved patient experience and adherence? * are the methods and tools established the most appropriate to ensure the completeness of the data collection? participants will follow a combined intervention consisting of: 1. pre-discharge educational meeting; 2. telephone nurse-led coaching sessions; 3. home telemonitoring of vital signs. in the main trial, researchers will compare data from the intervention group with a control group to assess whether it reduces hospitalization rates and improves self-care capabilities


Eligibility criteria:
inclusion criteria: * aged 65 and over * hospitalized for cardiac decompensation, regardless of ejection fraction (fe) value (preserved or decreased) * expected to be discharged home will be considered eligible. exclusion criteria: * individuals who lack the cognitive and/or physical capabilities (mini-cog +) for self-monitoring of vital signs, and without a caregiver available to assist them * people who receive other medical services
photon therapy face mask on dermatitis post head and neck radiotherapy

Conditions: Head and Neck Cancers - Nasopharyngeal

Summary: a randomized controlled trial (rct), 60 hnc patients who underwent radiotherapy (rt) with or without chemotherapy represented the sample of the study. they were assigned randomly into two equal groups, control group (cg) and study group (sg). routine methods of nursing were given during radiotherapy including health education, skin self-care, and skin protective agent for both groups cg and sg. the patients in study group treated with photon therapy (3x/week) for 6 weeks with a total of 18 sessions. the severity of skin reactions was assessed by the criteria of the radiation therapy oncology group (rtog) and dermoscopy for both groups were recorded.

this current study will be designed to prove the effect of photon therapy face mask on dermatitis post radiotherapy in patient with head and neck cancer. the measurements procedures will be conducted two times, before treatment application (pre-treatment) and after six weeks of treatment application (post-treatment). rtog scale will be used to asset the patient before and after end of therapeutic procedures. therapeutic intervention for the study was started at the same time for all groups of the study as following; photon therapy will be applied from the first until the last day of rt (3×/week, 14 sessions). during the photon therapy sessions, the whole irradiated area will be treated with 630 nm led phototherapy. treatment time will be 3 sessions per week for 30 min. set at 4 j/cm2 . patients who will receive photon therapy during radiotherapy treatment within 2 weeks in addition to medical treatment and routine methods of nursing will be given during radiotherapy, including health education, skin self-care, and skin protective agent. 0.9% normal saline cotton balls will be used to gently clean the wound and remove necrotic tissue, and the wound will be dried with sterile gauze.

Eligibility criteria:
inclusion criteria: * all patients were free from any skin diseases, all patients enrolled to this study signed their informed consent,all the patients who had nasopharyngeal tumor receiving radiotherapy who participated in this study, diagnosed by an oncologist and confirmed by mri, c.t and laboratory investigations). exclusion criteria: * patients with communication disorders, patients who were unwilling to take part in this treatment, patients with tumor recurrence, patients with tumor stage 3 or more and patients with skin diseases
profibrosing role of b lymphocytes in patients with systemic sclerosis.

Conditions: Scleroderma, Systemic

Summary: b lymphocytes are thought to play an important role in the pathophysiology of systemic sclerosis. in this study, the profibrosing role of b lymphocytes of patients with systemic sclerosis will be evaluated.

b lymphocytes of patients with systemic sclerosis will be assessed in term of interaction with fibroblasts from patients with systemic sclerosis and compared to healthy controls.

Eligibility criteria:
inclusion criteria: patients * systemic sclerosis according to acr-eular 2013 * written consent * available insurance healthy "blood" and healthy "biopsy" controls * written consent * available insurance exclusion criteria: patients * overlap with other connective tissue diseases * immunosuppressants in the past 12 months * corticosteroids ≥10mg/d * pregnancy or breast feeding healthy "blood" and healthy "biopsy" controls * systemic sclerosis according to acr-eular 2013 * another connective tissue diseases * immunosuppressants in the past 12 months * corticosteroids ≥10mg/d * pregnancy or breast feeding * with dysimmune inflammatory diseases (except thyroiditis) * presenting an infection in progress or within the previous 15 days

Keywords: systemic sclerosis b lymphocyte
efficacy of automated text messaging services

Conditions: Sleep; Physical Therapy

Summary: the goal of this clinical trial is to test automated text messaging as an effective behavior change intervention in physical therapy patients. the main purpose of this study was to trial sleep hygiene education for improving physical therapy patients' sleep through the use of daily automated text messaging. researchers will compare two groups to see if the intervention group which consisted of participants getting daily automated text messages for sleep hygiene tips would be effective in improving sleep, health, pain, and function compared to a group that is receiving traditional physical therapy alone.

participants will be recruited from the outpatient physical therapy clinic verbally by their therapist and by an informational handout they receive from the therapist. the student researcher (who also works at this clinic) will then contact the participant to set up a time to complete the initial survey questions at the clinic in a private treatment room. during the initial visit, participants will read through and sign informed consent explaining the procedures and expectations of them during the study. the participants will then complete the following questionnaires: pittsburgh sleep quality index, sleep hygiene index, medical outcome survey-sleep 9, perceived stress scale, numeric pain rating scale, and patient specific functional scale. the participants will randomly be assigned to one of two groups. the intervention group will receive daily automated text messages scheduled for 8:00 pm every evening. the text messages will include a variety of sleep hygiene behavioral tips for the participant to try. this will last for a total of four weeks. the control group will not receive any intervention during this time frame. following the four weeks, student researchers will return to each participant's clinic to collect the same data that was collected at the initial visit. each participant will have a total of 2 sessions to complete with each session taking approximately 15-30 minutes to complete.

Eligibility criteria:
inclusion criteria: adults 18 years and older seeking outpatient physical therapy exclusion criteria: inability to access a smart-phone or computer
is the artificial pancreas, without carbohydrate counting, efficient and safe in an outpatient setting

Conditions: Type 1 Diabetes; Autoimmune Diabetes

Summary: this is a pilot, interventional clinical trial to assess the effectiveness and safety of artificial pancreas (ap) using the arg algorithm closed-loop system in a monitored 3-day period outpatient study. once the safety of the device has been validated in the open-loop first 3-day period (continuous subcutaneous insulin infusion (csii) plus continuous glucose monitoring (cgm)) the investigators will move the study to the second 3-day closed-loop period, without carbohydrate (cho) counting.


Eligibility criteria:
inclusion criteria: * patient has been diagnosed with t1dm at least two years ago and has been using an insulin pump and a cgm for at least 6 months prior to the trial first visit * patient is \>18 and \<65 years * patient has hba1c \< 10% * woman in premenopausal age agrees to use contraceptive methods * woman in premenopausal age has negative b-hcg in the tests performed in the trial * patient is trained in cho counting * patient has signed informed consent and has the ability to understand the nature and intent of the study including the ability to comply with study procedures and is willing to keep scheduled visits exclusion criteria: * patient has been hospitalized for diabetic ketoacidosis in the last 12 months * patient has experienced severe hypoglycemia with loss of consciousness in the last 12 months * patient has a history of coronary disease or cardiac failure * patient with uncontrolled arterial hypertension * patient with a condition that makes the researcher believe that it might increase the chance of hypoglycemia * patient has symptoms compatible with active infectious disease * patient has cystic fibrosis * pregnant women, or women with the intention of getting pregnant; women breastfeeding * patient has been hospitalized for psychiatric treatment in the last 6 months. * patient with a diagnosis of adrenal disease * patient has abnormal laboratory values for liver function: transaminase \> 2x upper limit normal * patient has abnormal laboratory values for renal function: gfr \< 60 ml/min/1.73m2 * patient has active gastroparesis * patient is under oncological treatment * patient has taken acetaminophen 72 hours previous to the study

Keywords: diabetes technology t1dm artificial pancreas closed-loop