Kornimate/medical-research-clean huggingface dataset:
a study in belgian children hospitalized with respiratory syncytial virus related acute respiratory infections

Conditions: Respiratory Syncytial Virus

Summary: the purpose of the study is to assess viral kinetics and clinical symptoms kinetics in pediatric patients hospitalized with respiratory syncytial virus (rsv) confirmed lower respiratory tract infection (lrti).

this is an exploratory prospective study (a study in which the patients are identified and then followed forward in time for the outcome of the study). the study will consist of two phases: a screening phase (day 1) and an assessment phase (day 2 to day 7). during screening phase, in pediatric patients hospitalized with lrti and from whom the informed consent form was obtained, diagnosis of rsv infection will be performed within 24h from the hospital admission, using a sofia poc test on nasal specimens. during the assessment phase the collection of nasal specimens will be done daily for a maximum of 6 days (day 2 to day 7 of hospitalization) or until patient discharge from hospital. approximately 50 patients will be enrolled in this study. the total duration of the study for each participant will be approximately 7 days. the study duration will extend during 1-3 rsv epidemic seasons, or until the targeted number of 50 rsv hospitalized children have completed the study.

Eligibility criteria:
inclusion criteria: * legal representative has provided ethics committee approved written informed consent prior to any study-related procedure(s) being performed and is willing to allow the participation of child to the study for 7 consecutive days or until hospital discharge (whatever comes first) * participant hospitalized with lower respiratory tract infection (lrti) during respiratory syncytial virus (rsv) epidemics, within 24h of hospitalization. the diagnosis of lrti will follow the standard medical procedure in the hospital unit * onset of acute respiratory symptoms was less than or equal to 5 days ago * for the participation in the assessment phase the hospitalized participant will have an rsv confirmed infection based on sofia rsv point of care (poc) test exclusion criteria: - participant does not fulfill the inclusion criteria

Keywords: respiratory syncytial virus rsv lower respiratory tract infection lrti acute respiratory infection belgian children
a study of lor-253 hcl in patients with advanced or metastatic solid tumours

Conditions: Advanced or Metastatic Solid Tumours

Summary: this is an open-label, phase 1 study to determine the maximum tolerated dose (mtd) or appropriate target dose if mtd not reached to identify the recommended phase 2 dose of lor-253 hcl in patients with advanced or metastatic solid tumours.


Eligibility criteria:
inclusion criteria: 1. male or female 18 years of age or older. 2. histologically confirmed diagnosis of solid tumour for which no effective therapy is available or that is unresponsive to conventional therapy. 3. meet laboratory parameter requirements at study entry. exclusion criteria: 1. chemotherapy, radiotherapy, biologic therapy, immunotherapy or any other investigational drugs within 21 days of beginning study treatment with lor-253 hcl. 2. a hematologic malignancy. 3. a history of brain or other central nervous system metastases. 4. have a presence of a significant infection. 5. clinically significant autoimmune disease. 6. uncontrolled intercurrent illness. 7. with iron or copper overload syndromes. 8. pregnancy or breast feeding.
oxygen reserve index for kids

Conditions: Hypoxia

Summary: in infants less than two years old the new oxygen reserve index (ori) will be measured during general anaesthesia. it will evaluated if and how ori-monitoring gives earlier warning of hypoxaemia than conventional oxygen saturation measurement.

the oxygen reserve index (ori) is a new development in multiple wavelength pulse oximetry, reflecting the arterial partial oxygen pressure (pao2) continuously and non-invasively by an index. in contrast to established standard oxygen saturation (spo2) measurements, ori detects a drop of pao2 until the threshold of 100 mmhg. during anaesthesia induction-associated apnoeic periods ori may detect a drop of pao2 early enough for the anaesthesiologist to interrupt the intubation procedure and re-start oxygenation. in contrast, due to the flat upper part of the oxyhaemoglobin dissociation curve, spo2 stays at values above 90% until pao2 falls below 60mmhg. at this point, spo2 drops rapidly and a pro- longed hypoxic dip is the consequence. to avoid this potentially harmful hypoxic dip, continuous monitoring of pao2 using ori would be advantageous during anaesthesia induction phase. this clinical study aims to evaluate the time benefit between alarm of hypoxaemia by the ori-monitoring and the start of the dropping of oxygen saturation. pre-set and pre-described ori-alarms will be checked for their utility and a new ori-alarm will be defined that is potentially more useful. as secondary endpoints the study examines the correlation of ori with po2, the influence of patient or measurement characteristics on the correlation of ori with po2 and the influence of the measurement site on ori-measurement.

Eligibility criteria:
inclusion criteria: * small infants \< 2 years scheduled for elective surgery with general anaesthesia. exclusion criteria: * emergency procedures, lack of informed consent of legal guardian
a pilot rct to improve cognitive processing speed in acute sci

Conditions: Spinal Cord Injuries; Cognitive Dysfunction; Cognitive Impairment; Acute Spinal Cord Injury

Summary: this study seeks conduct a pilot study to test whether a cognitive training program can improve processing speed abilities in individuals with acute traumatic spinal cord injury.

spinal cord injury (sci) newly affects approximately 18,000 persons in the us per year. decades of research have focused on the physical limitations associated with sci, as well as therapies for addressing these physical problems. however, it is becoming better acknowledged that many individuals experience significant problems with their cognitive abilities, such as attention, memory, and the time it takes them to process information. research has shown that people who have cognitive difficulties, compared to those with a purely physical disability, are less likely to be employed, engage in fewer social and work-related activities, have greater difficulties carrying out routine household tasks, and are at higher risk for mental illness. if cognitive issues arise after an sci, it is more likely that a person would have a more challenging time adapting the many lifestyle changes brought about by their injury, would benefit less from their rehabilitation program, and have more difficulty rejoining the workforce. as it stands, cognitive assessment or rehabilitation is not part of the standard of care for individuals after their sci because of the relative lack of research in this area. this study seeks conduct a multisite pilot study to test whether a cognitive training program can improve processing speed abilities in individuals shortly after they experience their sci, with the hopes that this early intervention will improve the trajectory of their overall health and well-being.

Eligibility criteria:
inclusion criteria: * 18-59 years old * recent traumatic sci (approximately 6 months post-injury) exclusion criteria: * no other significant neurological, psychiatric or substance use history * no significantly impairing visual disturbance

Keywords: processing speed
craniosacral therapy for concussion symptoms

Conditions: Post-Concussion Syndrome

Summary: this study investigated the utilization of craniosacral therapy (cst) in patients with post-concussion syndrome (pcs) and capture patient-reported perceptions of their lived experiences of treatment effect upon their symptoms. the first part part was a 10 year chart review of patients who sought out cst to capture data from the medical records. the second part was an anonymous post treatment survey.


Eligibility criteria:
inclusion criteria: * charts were extracted from a group of 212 of patients with a history of concussion to a final chart review size of 67. these patients had specifically sought of cst to address symptoms of post concussion syndrome. exclusion criteria: * was determined for the 2nd part of study: post treatment outcome survey. final group size of 47 excluded those under age 14 and those with confounding medical or personal issues or involved in litigation.
use of adult bone marrow mononuclear cells in patients with long bone nonunion

Conditions: Long Bone Nonunion

Summary: the aim of the study is to determine the safety and feasibility of autologous mononuclear stem cells in long bone nonunion; and moreover, to evaluate the efficacy of the treatment.

in this study the investigators examine the improvement of conventional surgical treatment of long bone nonunion with the administration of bone marrow stem cells in order to achieve a higher percentage of healing and tissue reparation.

Eligibility criteria:
inclusion criteria: * diagnosed long bone nonunion * age from 18 years old exclusion criteria: * active infection * cancer patients * concomitant serious illness * pregnant women * evidences of mental illness * previous alcohol or drug dependences * previous malignant disease during last 5 years, except for basal carcinoma

Keywords: bone nonunion bone marrow mononuclear fracture
a drug-drug interaction study of mk 8527 with a combined oral contraceptive (lng/ee)

Conditions: Human Immunodeficiency Virus (HIV); HIV Pre-Exposure Prophylaxis

Summary: this study is designed to assess the effect of a single dose of mk-8527 on the single-dose pharmacokinetics (pk) and the safety and tolerability of levonorgestrel/ethinyl estradiol (lng/ee) in healthy adult postmenopausal or ovariectomized female participants.


Eligibility criteria:
inclusion criteria: * is in good overall health * assigned female at birth exclusion criteria: * has a history of clinically significant endocrine, gi, cardiovascular, hematological, thromboembolic, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases * is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit or expected during the conduct of the study or has a history of clinically significant psychiatric disorder of the last 5 years * has a history of cancer (malignancy)
effect on weight loss of exenatide versus placebo

Conditions: Type 2 Diabetes Mellitus

Summary: this trial is designed to compare the effects of twice-daily exenatide and twice-daily placebo on weight loss. this trial will evaluate overweight and obese subjects with type 2 diabetes who have inadequate glycemic control with metformin, sulfonylurea, or metformin plus a sulfonylurea. subjects will be treated with exenatide or placebo in addition to their current oral antidiabetes agent regimen and participate in a lifestyle modification program.


Eligibility criteria:
inclusion criteria: * diagnosed with type 2 diabetes for at least 6 months * have been treated with a stable dose of the following for at least 6 weeks prior to screening: \*immediate or extended release metformin, or \*a sulfonylurea, or \*a fixed-dose sulfonylurea/metformin combination therapy * have an hba1c of 6.6% to 10.0%, inclusive * have a body mass index (bmi) of 25 kg/m\^2 to 39.9 kg/m\^2, inclusive exclusion criteria: * are treated with any of the following excluded medications: \*exogenous insulin, thiazolidinedione, or alpha-glucosidase inhibitor for more than 1 week within 6 weeks of screening; \*symlin injection at any time; \* byetta injection within 3 months of screening or discontinuation of therapy at any time due to adverse reaction; \*drugs that directly affect gastrointestinal motility; \*use of a weight loss drug (including those available over the counter) within 3 months of screening; \*chronic (lasting longer than 2 weeks) systemic corticosteroids (excluding topical, intranasal, and inhaled preparations) by oral, intravenous, or intramuscular route within 2 months of screening * have conditions contraindicating metformin and/or sulfonylurea use * have had a change in lipid-lowering agents within 6 weeks of screening * have received glucagon-like peptide-1 (glp-1) analogs, or dipeptidyl peptidase-iv inhibitors (dpp-iv inhibitors) or have previously participated in this study * have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry

Keywords: diabetes overweight obesity weight loss exenatide amylin lilly
limbus-derived stem cells for prevention of postoperative corneal haze

Conditions: Corneal Scars and Opacities

Summary: this is a investigator-initiated pilot clinical trial to ascertain the safety and efficacy of application of ex-vivo cultivated limbal stem cells in human eyes for treating corneal haze after photo-therapeutic/refractive keratectomy (ptk/ prk) and collagen cross linking (cxl). instead of using adjunctive medical therapy like application of mmc (mitomycin), a technique of cell delivery with fibrin sealant can be used. these cells are harvested from therapeutically accepted and serologically tested cadaveric corneas. the isolated limbal epithelial and mesenchymal or stromal cell suspension will then be cultured in cgmp laboratories and be tested for sterlity. these cells have also been shown to be effective in treating haze in laser refractive surgery in an animal model. our initial experience of using these cells in a previous clinical trial showed that they were effective in preventing corneal haze in patients with burns and ulcers.

in this pilot clinical trial, patients undergoing photo therapeutic/refractive keratectomy (ptk/ prk) and collagen cross linking (cxl), will be given human limbus-derived corneal stem cells to assess the safety of these cells. cells will be cultivated in a cgmp laboratory using standardized culture technique; from the limbal rims of cadaveric corneoscleral donor tissues that are therapeutically accepted and serologically tested. briefly the limbal tissue will be cut up into small pieces and digested overnight using an enzyme (collagenase l). the cells obtained from the digest will be cultured on a petri-dish using 2% serum and growth factors. a mixture of limbal epithelial cells and limbal stromal cells obtained from these cultures will be used in surgical procedures in a ratio of 2:1, after all the sterility checks. mixed suspension of the limbal epithelial and the stromal cells at a concentration of 50000 cells/ul diluted in the thrombin component of fibrin sealant (tiseel, baxter) will be applied. the primary outcome measure is safety of this treatment and the secondary outcome measure is their efficacy that will be assessed at 1 month time points by (1) clinical photography using a standard method where multiple blinded observers will grade the clinically apparent change in haze and (2) objective quantification of the amount of light scattering using densitometry analysis function in oculus pentacam (oculus optikgeräte gmbh).

Eligibility criteria:
inclusion criteria: * adult patients between20 to 40 years of age * meeting standard selection criteria for bilateral ptk/prk or cxl * no systemic diseases * eligible to give informed consent * no other ocular co-existing pathologies exclusion criteria: * undergoing surgery in only one eye * grossly asymmetric pathology * refusal to give informed consent * not agreeable or uncooperative for corneal imaging * unlikely to come for follow-up for 1 month * international and out-station patients

Keywords: phototherapeutic keratectomy (ptk) photorefractive keratectomy (prk) collagen cross-linking (cxl) stem cell therapy
effect of pre-emptive intravenous immunoglobulin (ivig) on the incidence of septic episodes in pediatric burn patients

Conditions: Burn Shock

Summary: effect of pre-emptive intravenous immunoglobulin administration on the incidence of septic episodes in pediatric burn patients: a randomized controlled study.

after randomization, treatment and control groups will receive parkland formula (4 ml/kg per percent total burn surface area; (tbsa), counting moderate (partial thickness) and severe (full thickness) burn area only) using ringer's lactate solution (half of the fluid will be given over the first eight hours and the remaining half will be given over the next 16 hours), plus normal 24-hour maintenance fluid requirements using glucose solution. when initiating parkland, treatment group (group a) will receive intravenous immunoglobulin ivig (liv-gamma "s/d treated human immunoglobulin" 2.5 grams/50 ml) with a dose of 200 mg/kg once on admission. * on each septic or septic shock episode in either groups, the patients will be treated with appropriate antibiotics empirically or culture-based. * assessments * on admission, all patients included in the study will be fully examined clinically to identify the extent and area of burn and clinical signs of infection or dehydration as fever, respiratory rate, urinary output and capillary refill. besides, non-invasive blood pressure (systolic blood pressure (sbp), diastolic blood pressure (dbp) and mean arterial blood pressure (map)), electrocardiogram and arterial oxygen saturation will be assessed. * parameters to be measured * serum immunoglobulin g( igg) level, * serum micro rna (mir-25) , * serum c reactive protein (crp) level, * serum lactate, * serum procalcitonin * serum malondialdehyde(mda). * serum glutathione peroxidase . * in addition, complete blood picture with differential, coagulation profile, liver function tests (alanine transaminase (alt), aspartate amino transferase(ast), albumin and bilirubin), and kidney functions (blood urea nitrogen (bun) and serum creatinine) will be evaluated. pan cultures (blood with/without wound culture, throat swab or sputum culture and urinary analysis and culture), will be withdrawn for baseline readings and redrawn if any signs of systemic inflammatory response,

Eligibility criteria:
inclusion criteria: all burn patients 1 to 5 years old with 10% or greater burn area of tbsa . exclusion criteria: * patients with septic shock (evidence of infection and inotropes) . * burns more than 48 hours duration.
ppi sequencing study

Conditions: Gastro-Oesophageal Reflux Disease

Summary: the purpose of this study is to assess how patients with gastro-oesophageal reflux disease (heartburn) who are currently receiving treatment with a proton pump inhibitor but are still experiencing symptoms will benefit from a change in treatment.


Eligibility criteria:
inclusion criteria: * persisting symptoms of gord despite previous treatment with a full dose proton pump inhibitor * informed consent * over 18 years of age exclusion criteria: * current course of proton pump inhibitor treatment for more than 8 weeks prior to enrolment in the study; * more than 1 other course of ppi treatment in the previous 12 month; * previous use of esomeprazole; * presence of alarm symptoms.

Keywords: heartburn reflux proton pump inhibitor gerd gord
risk stratification in end stage renal disease (esrd) - isar study

Conditions: End Stage Renal Disease; Chronic Kidney Disease; Cardiovascular Event; Sudden Cardiac Death

Summary: the purpose of this study is to evaluate the use of non-invasive markers of the autonomic function and micro- and macrocirculation to predict mortality and cardiovascular end points in end-stage renal disease patients. furthermore we aim at getting new insight into the insufficiently understood pathophysiology leading to excessively high cardiovascular and non-cardiovascular mortality in dialysis patients.


Eligibility criteria:
inclusion criteria: 1. age 18 or older 2. end-stage renal disease (esrd) and receiving maintenance hemodialysis exclusion criteria: 1. any clinically significant infection. 2. pregnancy 3. history of malignant disease with a prognostic life expectancy less than 24 months 4. missing of written and informed consent

Keywords: end stage renal disease chronic kidney disease cardiovascular event sudden cardiac death autonomic function
special investigation (follow-up survey of the study of adalimumab (d2e7) for prevention of joint destruction in patients with rheumatoid arthritis in japan (m06-859 (nct00870467))

Conditions: Rheumatoid Arthritis

Summary: the present survey was conducted to evaluate the effectiveness and safety of treatment with adalimumab during the 52-week period following completion of the treatment period in study nct00870467 (m06-859) in participants who continued treatment with adalimumab for 52 weeks.

this survey was conducted to assess the risk and benefit of continuing or discontinuing biological therapy with adalimumab (humira) during the 52-week period following completion of the treatment period in study nct00870467 (m06-859).

Eligibility criteria:
inclusion criteria: * the participants were patients who continued treatment with adalimumab until the end of the treatment period in the nct00870467(m06-859) study and provided informed consent to participate in the present follow-up survey. exclusion criteria: * participants who used biological agents other than adalimumab after the period of treatment in the nct00870467(m06-859) study were excluded from the present follow-up study.

Keywords: rheumatoid arthritis
randomized phase ii trial induction therapy for early stage breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to find out if the combination of docetaxel and capecitabine can shrink the size of breast tumors and preserve the breast.

the purpose of this study is to identify new chemotherapy treatment regimens with better response rates and to find out if the combination of docetaxel and capecitabine can shrink the size of breast tumors and preserve the breast. induction chemotherapy offers the possibility of less surgery and determines tumor sensitivity in vivo. previous trials have demonstrated that complete pathologic response in the breast at surgery corresponds with improved outcome. additionally, we will correlate specific molecular markers in the breast tumors before and after chemotherapy, with response to treatment. expression of these molecular markets may be used in the future to predict the likelihood of response to chemotherapy given post-operatively.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed breast carcinoma. * early stage breast cancer (stage 1, 2, 3). * no evidence of disease outside the breast or chest wall, except ipsilateral axillary lymph nodes. * 18 years of age or older. * final eligibility for a clinical trial is determined by the health professionals conducting the trial. exclusion criteria: * prior chemotherapy, hormonal therapy, biologic therapy or radiation therapy for breast cancer. * major surgery within 28 days of study entry. * evidence of central nervous system (cns) metastases. * final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Keywords: breast cancer