Kornimate/medical-research-clean huggingface dataset:
the optimizing treatment of pegifn alfa in hbeag-negative chb patients with low level hbsag

Conditions: Chronic Hepatitis B

Summary: as hbsag clearance is uncommon in chronic hepatitis b (chb) patients on nucleoside analogues (nas) therapy. the purpose of this study is to optimize hbsag clearance in chb patients with sequential treatment of pegylated interferon alpha and nas.

in order to optimize hbsag clearance in chb patients with low level hbsag, the investigators enrolled patients who had received, and responded to, nas for more than 12 months(see the inclusion criteria), and patients are switched to receive peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week. the longest course of treatment is 96 weeks. after treatment, patients will be followed up for 24 weeks. during the 96 weeks course of treatment, hbsag level will be monitored. when hbsag level is less than 0.05 iu/ml, peginterferon treatment will be stopped and patients will receive 24 weeks follow up.

Eligibility criteria:
inclusion criteria: 1. chb patients who had received single nas for more than 12 months. 2. hepatitis b e antigen (hbeag)-negative. 3. hepatitis b surface antigen (hbsag) positive and \<1000 iu/ml. 4. hepatitis b virus dna \<100 iu/ml. exclusion criteria: 1. patients with liver cirrhosis, hepatocellular carcinoma or afp \>2 uln or other malignancies. 2. patients with other factors causing liver diseases. 3. pregnant and lactating women. 4. patients with concomitant hiv infection or congenital immune deficiency diseases. 5. patients with diabetes, autoimmune diseases. 6. patients with important organ dysfunctions. 7. patients with serious complications (e.g., infection, hepatic encephalopathy, hepatorenal syndrome, gastrointestinal bleeding.) 8. patients who receive antineoplastic or immunomodulatory therapy in the past 12 months. 9. patients with a previous use of ifn anti hepatitis b virus treatment or have nas drug resistance. 10. patients who can't come back to clinic for follow-up on schedule.

Keywords: peginterferon alfa chronic hepatitis b
impact of transition programs on readiness and quality of life in ibd

Conditions: Inflammatory Bowel Disease (IBD)

Summary: this study is a randomized controlled trial comparing two transition models for adolescents with inflammatory bowel disease (ibd) moving from pediatric to adult care. patients aged 16-19 years with ibd will be randomized to either a letter-based transition approach (involving a referral supported by a pediatrician's clinical report) or a combined visits-based approach (including joint consultations with both pediatric and adult gastroenterologists). the primary outcome will be transition readiness assessed using the transition readiness assessment questionnaire (traq). secondary outcomes include quality of life (measured by the pediatric quality of life inventory™), disease activity, and healthcare utilization. participants will be evaluated at baseline, six months, and one year. the study aims to establish an evidence-based transition model by determining which approach better facilitates a successful transition from pediatric to adult gastroenterology care for young patients with ibd.


Eligibility criteria:
inclusion criteria: * written informed consent * ibd diagnosis according to current guidelines * age between 16 and 19 years * disease in clinical remission or with mild activity exclusion criteria: - subjects unable to provide a free and valid consent to study participation

Keywords: transition pediatric inflammatory bowel disease
sacral savers: study of prevention and enhanced healing of sacral and trochenteric ulcers

Conditions: Healing Ulcer

Summary: the purpose of the study is to investigate the ability of the product "sacral saver," to prevent and /or help healing bed sores.

the purpose of this research study is to investigate the ability of the product "sacral savers." to prevent and/or help healing of bed sores, in patients in health care facilities. the sacral saver device consists of a sheet of strong bubble-wrap-like material, folded at one end and covered by a nylon sham with a pocket in which the bubble wrap is placed. the assembled device is placed under the bed sheet in such a way that the small of the back rests on the fold. this will lift the back and reduce the pressure of the buttocks on the bed. when lying on the side, it will reduce the pressure on the hip. participants are being asked to participate in this study because you are at risk for, or already have a bedsore on the buttocks or the hip.

Eligibility criteria:
inclusion criteria: * any patient who is immobilized for prolonged periods, either in acute care, or chronic care situations. * all patients with: paralysis, quadriplegia, paraplegia, trauma patients, requiring prolonged immobilization, patients on ventilators. * all patients with pre-existing pressure ulcers in the lower back and or hip regions. exclusion criteria: * there are no age, gender or co-morbidity exclusions

Keywords: sacral and trochenteric pressure ulcers
real-time diagnosis of diminutive colorectal polyps using ai

Conditions: Colorectal Neoplasms; Colorectal Polyp

Summary: correct endoscopic prediction of the histopathology and differentiation between benign, pre-malignant, and malignant colorectal polyps (optical diagnosis) remains difficult. artificial intelligence has great potential in image analysis in gastrointestinal endoscopy. aim of this study is to investigate the real-time diagnostic performance of ai4crp for the classification of diminutive colorectal polyps, and to compare it with the real-time diagnostic performance of commercially available cadx systems.

correct endoscopic prediction of the histopathology and differentiation between benign, pre-malignant, and malignant colorectal polyps (optical diagnosis) remains difficult. despite additional training, even experienced endoscopists continue to fail meeting international thresholds set for safe implementation of treatment strategies based on optical diagnosis. multiple machine learning techniques - computer-aided diagnosis (cadx) systems - have been developed for applications in medical imaging within colonoscopy and can improve endoscopic classification of colorectal polyps. aim of this study is to explore the feasibility of the workflow using ai4crp (a cnn based cadx system) real-time in the endoscopy suite, and to investigate the real-time diagnostic performance of ai4crp for the diagnosis of diminutive (\<5mm) colorectal polyps. secondary, the real-time performance of commercially available cadx systems will be investigated and compared with ai4crp performance.

Eligibility criteria:
inclusion criteria: * age \>18 years; * patients with at least one colorectal polyps encountered during colonoscopy; * patients referred for a colonoscopy by the dutch bowel cancer screening program, patients undergoing a colonoscopy for endoscopic surveillance, or patients undergoing a colonoscopy because of complaints; * written informed consent. exclusion criteria: * patients with prior history of inflammatory bowel diseases (ibd) or polyposis syndromes; * patients with inadequate bowel preparations after adequate washing, suctioning, and cleaning manoeuvres have been performed by the endoscopist; * patients undergoing an emergency colonoscopy; * written objection in the patient file for participation in scientific research.

Keywords: artificial intelligence computer-aided diagnosis (cadx)
pilot program to personalize care & improve quality of life for women with ovarian cancer

Conditions: Ovarian Cancer

Summary: the purpose of this study is to find out if complementary and alternative medicines (cam) should be included with traditional therapy for women with ovarian cancer. some of the alternative medicines include non-traditional drug and herbal therapies along with dietary and nutritional strategies. only a few of these alternative medicines have been tested with women with ovarian cancer.

the study will be offered to women with ovarian cancer who are receiving care at the gynecologic oncology clinic at h. lee moffitt cancer center. prospective candidates, identified via chart review, will receive a mailing that describes and invites them to be screened for eligibility. potential participants seen in the clinic will also be approached and invited to participate. the informed consent process and pretesting will take place in the clinic, with exceptions made as needed for women who prefer to complete documents at home. the intervention, which will consist of four educational cam sessions, will be held on site in a private room at moffitt cancer center. immediately before and after each session, we will administer a brief on-site pre- and post-test. upon completion of the intervention, participants will be asked to complete a post-test on site or at home, depending on their preference. follow-up telephone calls will be made to the participants at 8 weeks after the last session. pre- and post-test measures will focus on quality of life, prior use of cam therapies, topic preferences, knowledge gained from the presentations, changed intentions and behaviors associated with cam, and satisfaction with the program.

Eligibility criteria:
inclusion criteria: * a diagnosis of ovarian cancer * an eastern cooperative oncology group (ecog) score of 2 or less with a life expectancy of at least 12 months * a patient being treated by a gynecologic oncologist in the center for women's oncology * ability to read, understand, and sign the informed consent form * ability to read, write and understand english, which will be the language used in the materials and oral presentations * willingness to complete pre-test and post-test questionnaires * willingness to complete brief questionnaires at each session * willingness to participate in one follow-up telephone interview at 8 weeks after the final session * willingness to participate in four sessions that take place at moffitt cancer center * access to transportation, with the ability to travel to and from moffitt to participate in the sessions

Keywords: complementary medicine traditional medicine
preoperative or postoperative therapy of patients with stages ib, ii, iiia non-small cell lung cancer

Conditions: Lung Cancer

Summary: in this phase ii study, we plan to evaluate several novel components of therapy. in patients with potentially resectable stages iib (t3n0) and iiia we will compare weekly paclitaxel and carboplatin with concomitant radiation therapy versus weekly paclitaxel and every 4 week carboplatin in the preoperative (neoadjuvant) setting. for patients with potentially resectable stage ib, iia and iib (t2n1) tumors, weekly paclitaxel and every 4 week carboplatin will be given pre-operatively (neoadjuvant). the feasibility of resection will be evaluated in the neoadjuvant group of patients. the continued study of concurrent radiation therapy with weekly paclitaxel and carboplatin will be evaluated in those patients with stage iib (t3n0) and iiia disease who initially had resection (adjuvant setting). lastly, weekly paclitaxel and carboplatin every 4 weeks will be evaluated as an adjuvant program in patients who had completely resected stage ib, iia and iib (t2n1).

upon determination of eligibility, neo-adjuvant patients will be randomly assigned to one of two treatment arms: * arm a paclitaxel + carboplatin + radiation therapy + surgery * arm b paclitaxel + carboplatin + surgery after surgery neo-adjuvant patients with a complete resection will either receive paclitaxel + carboplatin or no therapy, depending on their stage of disease at time of enrollment. patients with incomplete resection paclitaxel + carboplatin + radiation therapy. adjuvant patients who enter the study after complete resection will receive paclitaxel + carboplatin with or without radiation therapy based on initial stage of disease.

Eligibility criteria:
inclusion criteria: to be included in this study, you must meet the following criteria: * non-small cell lung cancer * neoadjuvant candidates must have potentially resectable disease * adjuvant candidates must have had complete resection * clinical stage ib, ii, or iiia non-small cell lung cancer * ecog performance status 0 or 1 * adequate bone marrow, liver and kidney function * no previous chemotherapy or radiation therapy for non-small cell lung cancer. * give written informed consent. exclusion criteria: you cannot participate in this study if any of the following apply to you: * stage iiia with n2 nodes \> 6 cm * stage iiib or iv disease * age \<18 years * ecog performance status 2 or higher * considered inoperable based on general medical condition * history of prior malignancy within five years * women who are pregnant or lactating please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
trial of high dose vitamin d in patient's with crohn's disease

Conditions: Crohn's Disease; Vitamin D Deficiency

Summary: crohn's disease is more common in areas of the world with less sunlight exposure. sunlight is a major source of vitamin d. there is some research to suggest that patient's with higher vitamin d levels are less likely to undergo surgeries and have better control of their disease. we intend to study the effects of high dose vitamin d supplementation in patients with vitamin d deficiency and crohn's disease. we hypothesize that patients given high doses will have less hospitalizations, surgeries, steroid use.

subjects are randomized to low or high dose vitamin d, and outcomes including steroid prescriptions, cd-related hospitalizations, cd-related surgeries, and the modified harvey-bradshaw index are measured.

Eligibility criteria:
inclusion criteria: * diagnosis of cd * age \>= 18 and \<75 * vitamin d deficiency or insufficiency (serum 25-hydroxyvitamin d \< 30ng/ml) exclusion criteria: * corticosteroid use in the last 4 weeks * cd-related surgery in the last 6 months * cd-related hospitalization in the last 4 weeks * pregnancy, intended pregnancy during the study period or nursing * serum calcium \>10.2 mg/dl * history of primary sclerosing cholangitis * history of undergoing an ileal pouch-anal anastomosis * current active perianal disease * history of nephrolithiasis in the past 2 years * anticipated change in therapy in the next 30 days (steroids, biologic initiation) * modified harvey-bradshaw index of 10 or more * history of decreased renal function (glomerular filtration rate \<30ml/min based on mdrd) or polycystic kidney disease * history of sarcoidosis * history of hyperparathyroidism * any other chronic condition that may preclude high doses of vitamin d such as lymphoma * concurrent use of hydrochlorothiazide, phenytoin, phenobarbital, carbamazepine or primidone * osteoporosis

Keywords: crohn's disease vitamin d deficiency
norepinephrine and vasopressin for rescue versus early vasopressin for vasopressor dependent sepsis

Conditions: Septic Shock

Summary: the norepinephrine and vasopressin for rescue versus early vasopressin for vasopressor dependent sepsis (nova) is a phase 3, multicenter, open-label, randomized controlled trial comparing an early vasopressin initiation strategy versus norepinephrine plus vasopressin initiation only as a rescue strategy for hemodynamic management of critically ill patients with vasopressor dependent sepsis.

sepsis is defined as a life-threatening organ dysfunction caused by a dysregulated body response to infection. its most severe form, septic shock, occurs when underlying circulatory and cellular metabolic abnormalities are pronounced, indicating greater severity and higher mortality. vasopressor use is a cornerstone aspect in the treatment of critically ill patients with sepsis-associated hemodynamic dysfunction, with norepinephrine, a catecholamine, being the vasopressor of choice. vasopressin is an endogenous peptide hormone with potential advantages over norepinephrine in a catecholamine-sparing strategy for treating sepsis-associated hemodynamic dysfunction. this is a phase 3, multicenter, open-label, randomized controlled trial. adult patients with sepsis-associated hemodynamic dysfunction in the icu may be eligible to participate. we aim to enroll 2,800 patients.

Eligibility criteria:
inclusion criteria: * patients with vasopressor dependent sepsis, defined by infection suspicion and antibiotic administration plus hypotension with the need of vasopressors for at least one hour; * admitted or expected to be admitted to the icu in the next 12 hours * adequate volume resuscitation in the opinion of the attending physician * use of norepinephrine \> 0.05μg/kg/min and ≤ 0.25μg/kg/min for at least 1 hour and at most 24 hours at the time of inclusion exclusion criteria: * use of norepinephrine \> 0.25μg/kg/min in the last 24 hours, except when administered transiently in the context of sedation for a procedure or the initial phase of volume resuscitation for a period of less than one hour * dialysis-dependent chronic kidney disease or acute kidney injury that received renal replacement therapy during current hospitalization or are expected to receive renal replacement therapy in the next 24 hours * use of other vasopressors (except norepinephrine) at the moment of inclusion * use of vasopressors for sepsis in the last 7 days * suspected or confirmed acute mesenteric ischemia * anaphylaxis or known hypersensitivity to the study drug * expect to die in the next 24 hours * medical team not committed to full support at the time of inclusion * previous inclusion in the study

Keywords: vasopressin norepinephrine vasopressor dependent sepsis septic shock critically ill
optimization of onpulse technology for patients with post surgical or vascular oedema

Conditions: Oedema; Neuropathy

Summary: this study aims to facilitate further optimization of a neuromuscular electrical stimulation device for use in patients whom are suffering from oedema and neuropathy


Eligibility criteria:
inclusion criteria: 1. aged 18 years and over 2. be a non-responder to the geko mk1\&2 device 3. able to understand the subject information sheet and willing to sign the written informed consent form. 4. able and willing to follow the protocol requirements. exclusion criteria: 1. has a pacemaker 2. pregnancy. 3. is contraindicated for the mk1\&2 device and/or the digitimer ds7a 4. recently diagnosed or suspected dvt
clinical impact of routine abdominal drainage after laparoscopic cholecystectomy

Conditions: Abdominal Drainage; Laparoscopic Cholecystectomy; Gall Stones

Summary: patients and methods: 100 patients were included in this study. they divided into two groups, group (a) with drain and group (b) without drain. the investigators recorded the effect of drainage on, postoperative pain (po-p) using visual analogue scale vas at 6, 24, 48 hours and 1 week postoperative nausea/vomiting at 6, 24, 48 hours postoperative, abdominal collection, hospital stay, chest complication, and postoperative body temperature.

the patients were randomized into two groups using enclosed envelope. group (a) with drain included 50 patients, and group (b) without drain included 50 patients. under general anesthesia, and same antibiotics (3rd generation cephalosporin) surgery was performed using conventional four ports umbilical port, port below xiphoid and two ports below right costal margin. pneumoperitonum at pressure 12 mmhg. in group a nelton catheter (no 20) was inserted at the end of operation. the intraoperative parameter observed included duration of the operation, amount of co2 used in the operation, bile escape, saline irrigation during operation and volume of blood loss were recorded. the patients started oral feeding 8 hours (h) postoperatively; abdominal ultrasound was done for all patients in both groups on day of discharge to show any collection or free fluid in the abdomen. the patients were usually discharged after removal of drain, and when the patient surgically free. postoperative pain was evaluated at 6 h, 24 h, 48, 1 week after operation using a visual analog scale (vas) with which each patients noted the severity of pain at each evaluated time using a linear between zero (no pain) and 10 (severe pain). postoperative analgesia in the form of non steroidal anti-inflammatory drug (nsaid) was administered intramuscularly when required. if the patients still complained of pain and required strong analgesic, (1 mg/kg pethidine intramuscularly) was administered. the total dose of these medications were recorded. postoperative maximum body temperatures were recorded at (6 h, 24 h, and 48 h) for all patients. ponv were assessed postoperative after 6 h, 24 h and after 48 h. metocloprpamide was given if the patients required reduction of nausea and the total dose of this medication was recorded. the frequency of vomiting was recorded.

Eligibility criteria:
inclusion criteria: * patients with gallbladder stones and laparoscopic cholecystectomy exclusion criteria: * patients above 80 years old * patients with acute cholecystitis * patients with history of upper laparotomy * patients with a hemorrhagic tendency due to cirrhosis * patients refused to give informed consent and patients who were converted to open cholecystectomy

Keywords: drain laparoscopic cholecystectomy pneumoperitonum
monotherapy versus bitherapy in non-severe hospitalized community-acquired pneumonia

Conditions: Community-acquired Pneumonia

Summary: the purpose of this study is to determine whether a monotherapy with a beta-lactam is not inferior to an association of a beta-lactam and a macrolide in treating adult patients with community-acquired pneumonia.


Eligibility criteria:
inclusion criteria: * age \>=18 years * new infiltrate on chest x-ray, unexplained by another disease process * presence of at least two of the following findings suggestive of pneumonia: fever or hypothermia, new or increasing cough, sputum production, pleuritic chest pain, tachypnea, dyspnea or focal signs on chest examination * need for hospitalization as defined by the emergency physician in charge of the patient exclusion criteria: * allergy to one of the study drugs * pregnancy * severe immunosuppression * recent (\ 48 hours * residency in a nursing home * previous use of more than 24 hours of any antibiotic * severe community-acquired pneumonia

Keywords: community-acquired infections pneumonia clinical stability antibiotics combination therapy atypical bacteria
iron status and lung function in pediatric asthma

Conditions: Pulmonary Function Tests

Summary: iron has a variable role regarding asthma and respiratory function. in addition, iron deficiency may affect spirometry results in asthmatic children. so, we aimed to assess the effect of ion status on lung function in childhood asthma

this cross-sectional study included fifty asthmatic children in the age group of 6-16 years. asthmatic patients were classified according to their complete blood count and iron profile into 2 groups: group 1; asthmatic children without iron deficiency anemia (ida), group 2; asthmatic children with ida. all patients underwent full history taking, clinical examination, laboratory investigations, asthma control test, and pulmonary function tests. pulmonary function testing was performed using standardized spirometry. lung function was measured by forced expiratory volume in one second (fev1), forced vital capacity (fvc), fev1/fvc, and maximal mid-expiratory flow (mmef 25-75%) of fvc. both patients' groups are compared.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of bronchial asthma: the diagnosis of bronchial asthma in the studied children was based on clinical examination the diagnosis of iron deficiency anemia was supported by criteria provided and updated by the world health organization exclusion criteria: * chronic lung diseases other than asthma severe systemic illnesses such as liver, renal diseases, and nutritional disorders

Keywords: asthma, pediatric, iron deficiency anemia