Kornimate/medical-research-clean huggingface dataset:
urinary biomarkers of renal injury in inflammatory bowel disease

Conditions: Inflammatory Bowel Diseases

Summary: the study aims to early detection of renal injury in patients diagnosed to have inflammatory bowel disease with normal kidney function test focusing on glomerular filtration barrier injury and tubular injury and it's relation to disease activity so precautions could be taken properly to prevent further renal injury later on .

inflammatory bowel disease (ibd) is a chronic and relapsing inflammatory condition of the gastrointestinal tract. crohn's disease and ulcerative colitis are the two principal types of ibd. the prevalence of ibd has been increasing worldwide . extraintestinal manifestations of ibd are common, occurring in 6% to 47% of patients involving nearly every organ system . renal and urinary system involvement are common in ibd patients with incidence varying from 4% to 23% and is greater in patients with more severe and long-standing disease. apart from secondary complications, such as nephrolithiasis, hydronephrosis and amyloidosis, other disorders have also been reported. membranous glomerulonephritis, rapidly progressive glomerulonephritis, mesangiocapillary glomerulonephritis, iga nephropathy, thin basement membrane disease and kidney granuloma found to be connected with ibd. in addition, non-specific morphological changes in the glomeruli of patients with ibd, like podocyte effacement and mesangial deposition of immunoglobulin and complement have been well documented. cases of interstitial nephritis reported to be attributed to the nephrotoxic effect of aminosalicylates which used in ibd treatment. alpha one microglobulin is a relatively small protein that undergoes glomerular filtration followed by reabsorption and catabolism in the proximal tubules. increased urinary α1-microglobulin concentration therefore provides an index of proximal tubule dysfunction . glomerular filtration barrier related protein changes have not been closely investigated in ibd patients . nephrin is podocyte-associated protein that play key roles in maintaining the structural and functional integrity of the kidney's filtration barrier. the shedding of nephrin reflects compromisation of podocytes' functional and structural integrity.

Eligibility criteria:
inclusion criteria: - patients diagnosed to have inflammatory bowel disease (ulcerative colitis or chron's disease )with age more than 18 years and normal kidney function test exclusion criteria: patients known to have renal disease due to other causes . diabetic patients . hypertensive patients
toripalimab combined with concurrent chemoradiotherapy in cervical cancer

Conditions: Cervical Cancer

Summary: to explore the efficacy and tolerance of adding toripalimab simultaneously and subsequently to concurrent platinum-based chemoradiotherapy in patients with locally advanced cervical cancer.

up to now, there have been several prospective studies exploring the effectiveness of pd-1 inhibitors in patients with recurrent/ metastatic cervical cancer. the results showed that the overall objective response rate (orr) was between 12.2% and 55.6%, and pembrolizumab was approved by the us food and drug administration for patients with advanced pd-l1-positive cervical cancer who experienced progression during or after chemotherapy. however, the evidence of using pd-1 inhibitors together with concurrent chemotheradiotherapy in patients with locally advanced cervical cancer is rare, so we initiated this single arm prospective phase ii clinical study. the purpose is to explore the efficacy and tolerance of adding toripalimab simultaneously and subsequently to concurrent chemoradiotherapy in patients with locally advanced cervical cancer.

Eligibility criteria:
inclusion criteria: * age between 18 and 75; * untreated patients with pathologically proven locally advanced cervical cancer; * eastern cooperative oncology group (ecog) performance status of 0-1 * adequate hematological, renal and hepatic functions: 1. hemoglobin \> 8.0 g/dl 2. neutrophils \> 2000 cells/μl; leukocytes \> 4 × 109/l 3. platelets \> 100 × 109/l g. serum urea nitrogen (bun) ≤ 1.5 × upper normal limit (unl) h. serum creatinine (cr) ≤ 1.5 × upper normal limit (unl) d. serum alt/ast ≤ 2.5× unl e. serum total bilirubin ≤ 1.5× unl * life expectancy \> 6 months * eligible for concurrent chemoradiotherapy assessed by principle investigator; * no obvious active bleeding; * written informed consent must be available before study registration exclusion criteria: * recurrent or distant metastatic disease; * prior malignancies (other than curable non-melanoma skin cancer) within 5 years; * active autoimmune diseases requiring systemic treatment or other diseases requiring long-term use of substantial amount of hormones or other immunosuppressants; * patients who need to receive systemic corticosteroids (dose equivalent to or higher than prednisone 10mg qd) or other immunosuppressants within 14 days before enrollment or during the study; * vaccination of live attenuated vaccine 30 days before enrollment, or planned vaccination of live attenuated vaccine during the study; * previous organ transplantation or hiv patients; * allergic to macromolecular proteins /monoclonal antibodies, or to any test drug component; * active acute or chronic viral hepatitis b or c. hepatitis b virus (hbv) dna\> 2000iu/ml or 104 copies/ml; hepatitis c virus (hcv) rna\> 103 copies/ml.
human umbilical cord stroma msc in myocardial infarction

Conditions: Chronic Ischemic Cardiomyopathy; Coronary Artery Bypass Surgery

Summary: the purpose of this phase 1/2 clinical trial is to evaluate the efficacy and safety of allogeneic human umbilical cordstroma derived multipotent stem cells (hucs-mscs) in myocardial infarction (mi). all subjects will be taken into the bypass coronary surgery prior to the cell administration. this 2-year study comprise three independent groups, where the first group (n=20) will take no cells, second group will take autologous bm-mncs (n=20), and third group (n=39) will be receiving allogeneic hucs-mscs. in all transplantations cells will be administered to the approximately 10 peri-infarct areas at one time. the infarct zone will be determined by the mr, spect and pet imaging. only male subjects between 30-80 years of age. the efficiency of the therapy will be evaluated according to the parameters measured by mr, spect, and echocardiography. all subject were taken into those measurements prior and 6, 12, 18 and 24 months after the operation.


Eligibility criteria:
inclusion criteria: * ischemic hearth disease who will experience cabg * %25\<ef\<%45 * nyha class ii-iv patients * hemodynamically stable exclusion criteria: * patient's in approval * acute cardiac decompensation * acute myocardial infarction * congenital heart disease * additional surgical heart disease other than coronary artery disease * malign arrhythmia * all malignancies * hba1c level \>%10 (86 mmol/mol) type ii diabetes mellitus * severe liver dysfunction * severe copd * coagulopathy * immunosuppressive treatment * acute hepatitis, hepatitis b, c and hiv infection * chronic liver and renal failure * collagen tissue disease * stroke * tb * hematological diseases * socially and mentally disabilities

Keywords: cellular therapy chronic ischemic heart disease phase 1/2 clinical study human umbilical cord multipotent stem cell human umbilical cord mesenchymal stem cell ischemic heart disease bone marrow mononuclear cell allogeneic stem cell transplantation
novel tracer methods to evaluate muscle protein metabolism in cirrhosis

Conditions: Cirrhosis

Summary: to determine the rate and mechanisms of skeletal muscle protein synthesis and breakdown in cirrhotic patients by using multiple tracers and single muscle biopsies.

the goal of this study is to identify the molecular regulatory mechanisms that result in loss of skeletal muscle in cirrhotic patients. current strategies involve prolonged tracer infusion and multiple muscle biopsies. we will use an innovative approach to determine the rates of skeletal muscle protein synthesis and breakdown using multiple tracers administered at short intervals followed by a single muscle biopsy. these studies are likely to provide a conceptual advance in determining the cellular and molecular responses of the skeletal muscle in cirrhosis.

Eligibility criteria:
inclusion criteria: * the diagnosis of cirrhosis based on liver biopsy and/or clinical, biochemical, and imaging criteria. * patients with child pugh score from a5- to b7 * control group: subject in control group should have serum alt and ast within normal range. exclusion criteria for both groups (cirrhotic and control) are: * diabetes * cancer * kidney failure * pregnancy * recent surgery (bowel resection or gastric bypass operation) * advanced cardiac or pulmonary disease * patient with thyroid disease \& coagulopathy ( inr \>1.4 and platelet count \<80,000/ml)
effects of eccentric hamstring training in prevention of hamstring injuries in sprinters

Conditions: Sport Injury

Summary: the goal of this clinical trail is to determine the effects of eccentric hamstring training, in prevention of hamstring injuries in sports involving sprinting among club level athletes. the main question it aims to answer is : - will eccentric exercises have an effect in the recovery of hamstring injuries and injury prevention in sprint performance sports among club-level athletes. participants will be divided into two groups. control group will perform conventional training program and interventional group will perform eccentric exercises.

the most frequent time-loss injuries in sports are hamstring injuries, which are particularly common in modalities that involve rapid accelerations and decelerations like high-speed running. the hamstring muscle group is more susceptible to stresses because of the way it is anatomically arranged.these injuries are more common in sprinters than in other athletes.ballistic motions like sprinting are typical in most contact and non-contact sports. the most frequent type of activity during sprinting is the running stride. the muscles aggressively extend and contract throughout each stride, forcing the linked segments to accelerate and slow down.in most club-level sports like football, cricket, sprinters and rugby sprinting is a crucial component of the sports and defines the performance of the athletes. if the athlete is a good sprinter he will perform more efficiently in sports. as sprinting is a high-intensity activity and is beneficial for athlete's general health but there are many injuries involved among these athletes. the injury can be disastrous for the athlete, resulting in extended recovery time and the possibility of persistent damage. injuries in professional athletes are disproportionately often hamstring-related.the most common form of hamstring injury is hamstring strain which can be caused due these reasons. hamstring injuries can be divided into three types; grade 1 which is a hamstring pull or strain, grade 2 partial muscle tear and grade 3 complete muscle tear. the hamstring muscle is very important as it is involved in generating forward motion. the cause of hamstring injury can be due to multiple activities but the most common is when athletes are sprinting at maximal speeds.

Eligibility criteria:
inclusion criteria: * age 18 to 28 years. * rugby players * male * athletes who have suffered a hamstring injury in the past 6 months. exclusion criteria: * those athletes who have undergone any surgery in the lower extremity and athletes with any other lower limb pathology are excluded.

Keywords: athletic injuries hamstring eccentric training prevention sprinters
melatonin for treatment of delirium in critically ill adult patients

Conditions: Delirium

Summary: the purpose of this study is to determine the feasibility of conducting a randomized controlled trial (rct) with melatonin for treatment of delirium in critically ill adult patients. from a feasibility perspective, the investigators believe that the proposed design will achieve the minimum enrollment rate necessary to conduct a future rct on a larger scale.

the prevalence of delirium is high in the intensive care unit (icu), yet there is no pharmacological treatment that has been proven effective. the investigators hypothesize that melatonin, given on a daily basis at 21:00, will safely decrease the mean duration of a delirium episode in icu patients. the current literature evaluating melatonin as a treatment for delirium is lacking, therefore more studies are needed. it is estimated that an alteration of sleep pattern can be found in up to 75% of patients with delirium. this raises the hypothesis that prevention and treatment of sleep disorders could potentially improve delirium. sleep and circadian rhythm disturbances are associated with low endogenous melatonin secretion and studies have shown that it also occurs in patients with delirium. thus, the objective is to conduct a phase ii double blind, placebo-controlled randomized trial comparing melatonin 9 mg to placebo to evaluate the feasibility of a future large-scale rct. participants will be followed during their stay in the icu and after their transfer on another unit up to a maximum of 14 days. feasibility of the larger trial will mainly be based on enrollment rates.

Eligibility criteria:
inclusion criteria: * patients aged 18 years or older admitted to the intensive care unit; * anticipated icu stay \> 48 hours; * icdsc score greater than or equal to 4 for a maximum of 48 hours prior to randomization. exclusion criteria: * known allergy or hypersensitivity to melatonin or to ingredients in ora-blend sf®; * use of melatonin within 24 hours prior to randomization; * presence of severe structural brain injury (intracranial hemorrhage or traumatic brain injury), severe major neurocognitive disorder, advanced neurodegenerative disease or hepatic encephalopathy; * diagnosis of schizophrenia, bipolar affective disorder, psychotic depression, uremic encephalopathy or alcohol withdrawal; * presence of active seizures, coma, aphasia or severe intellectual disability; * limited short-term vital prognosis; * diagnosis of delirium prior to icu admission; * pregnancy or breastfeeding; * absolute contraindication to receive enteral medication; * inability to understand or speak english or french; * total blindness.

Keywords: melatonin intensive care feasibility treatment critically ill icu
continuous glucose sensor profiles in non-diabetic subjects

Conditions: Healthy Subjects Without Type 1 Diabetes

Summary: the juvenile diabetes research foundation (jdrf) glucose sensor study group is carrying out a large, randomized clinical trial to assess the efficacy, safety and cost-effectiveness of use of real-time continuous glucose monitors (rt-cgm) as an adjunct to standard meter plasma glucose testing. although the primary outcome in the \>= 7.0% cohort is differences in hba1c levels, important secondary outcomes are differences in the percent of glucose sensor values either above or below the target glucose range of 70-180 mg/dl and differences in glucose variability. prevention of biochemical hypoglycemia is a particularly important outcome in the low hba1c cohort. since cgm systems measure interstitial rather than plasma glucose and cgm values differ from simultaneous plasma glucose values by up to 18%, it would be extremely useful for comparative purposes to establish a reference range of sensor values in healthy, non-diabetic control subjects for this study and other future investigations. the objective of this protocol is to establish such reference sensor glucose ranges in each of the 3 devices being utilized in the jdrf study.

1. after initial eligibility is determined, informed consent and assent are obtained from the parent/guardian and subject. 2. subjects will have the following tests performed: * hemoglobin a1c (using the dca2000 or equivalent device) * oral glucose tolerance test to obtain fasting and 2 hour plasma glucose levels * anti-gad, anti-ia2 and anti-insulin antibodies * subjects with an hba1c \>6.0% and/or fasting glucose levels \>100 and/or 2 hour glucose levels \>140 will be discontinued from the study. 3. subjects with normal a1c and glucose levels will be provided with an rt-cgm and home glucose meter (hgm) 4. an rt-cgm sensor will be inserted and initiated by study personnel. 5. subjects who would like to wear 2 sensors will be given 2 of the same type of rt-cgm. 6. subjects will be instructed to wear the sensor for 3-7 days (depending on the type of device) and measure the blood glucose on the hgm as needed to calibrate the sensor. 7. subjects will return to the clinical center after the 3-7 days of sensor wear to return the rt-cgm and hgm. * if the subject has less than 48 hours of sensor data he or she will be asked to wear another sensor and return 3-7 days later.

Eligibility criteria:
inclusion criteria: * age \> 8 years * body mass index (bmi) between the 10th to 90th percentile for age and sex (based on cdc, 2000 nomogram) and \< 28 kg body weight/meter in adult subjects * no significant chronic illness or taking any acute or chronic medications that might affect glucose metabolism. exclusion criteria: * history of diabetes or positive islet cell antibody testing
efficacy of melanostop peeling for improvement of melasma

Conditions: Melasma

Summary: participants with face melasma will receive 4 melanostop peel treatments containing 20% azelaic acid, 10% resorcinol and 6% phytic acid. peels will be performed at 2-week interval. they will also receive a facial tonic and cream for at home use, containing brightening ingredients: vitamin c, niacinamide, alpha arbutin, kojic acid. they will also receive sunscreen protection cream with spf 50, protecting against uva, uvb, hev and ir. products for at home use will be used twice a day, every day. measurements will be made at baseline, on the day of the forth peel treatment and 4 weeks after the last peel. measured parameters will be: mmasi score, visioface photography analysis, melasma area measurements, and melanin index, δe, cielab colour measurements with cortex skinlab combo (cortex technology asp, denmark).


Eligibility criteria:
inclusion criteria: * adult women aged between 20-50 years old. * melasma on the face * fitzpatrick phototypes i-iv * presenting facial melasma * in good health condition exclusion criteria: * breastfeeding and pregnancy * women presenting oral herpes * other skin diseases, arthritis, diabetes, diseases of thyroid gland * any known allergies to ingredients of the products used in the study * systemic or topical use of corticosteroids in the previous 6 months * antiaging or lightening cosmetic/estetic procedures in the last 2 months (for example: laser or ipl treatments, chemical peels,..) * taking drugs for skin lightening in the previous 2 months * smoking * lesions of unknown origin * oral or topical use of isotretinoin in the previous 6 months * active bacterial, viral or fungal infections of the skin * presence of keloid scars * immunodeficiency * moderate to severe acne * planned change in hormonal contraception or taking drugs that have an affect on hormonal balance during the course of the study * unrealistic expectations * refusal to use sunscreen protection and complying with instructions
audiovisual distraction in intensive care

Conditions: Anxiety

Summary: resuscitation patients are subject to constant stress of multifactorial origin: their state of health, the noisy environment of critical care, the multiple examinations and care provided, lack of sleep, stress from their loved ones... it is estimated that 60% of resuscitation patients have experienced stress and 40% have been anxious during their hospitalization in intensive care. this permanent anxiety is punctuated by stress peaks, particularly at the time of invasive procedures frequently performed in the icu. this stress is said to have a negative impact on patients' ability to recover and on their length of stay in the icu. what's more, these anxious symptoms can persist after hospitalization, leading to post-traumatic stress disorder. it therefore seems appropriate to find solutions aimed at reducing this stress. medication is often used to reduce stress and anxiety. although effective, these molecules have undesirable side-effects and can also hinder the patient's recovery. alternative methods are already being studied as replacement or supplementary therapies to drugs. these include music therapy, aromatherapy, hypnosis and virtual reality. virtual reality has been used on resuscitation patients to improve tolerance to mechanical ventilation and to the resuscitation environment in general.


Eligibility criteria:
inclusion criteria: * patients hospitalized in intensive care, post-operative intensive care and continuous monitoring; * patient receiving invasive care placement of peripheral venous line, nasogastric tube insertion, bladder catheterization, dressing stage iv pressure sores, heavy dressing lasting \> 15 minutes arterial gasometry by puncture; * patient of legal age; * patient with written consent; * patient with glasgow score equal to 15; * socially insured patient; * patient willing to comply with all study procedures and duration. exclusion criteria: * medical history contraindicating relax eyewear; * known and current abuse of alcohol and/or illicit drugs that may interfere with patient safety and/or compliance; * any condition that would make the patient unsuitable for the study: current presence of cognitive disorders (mms \< 15), severe psychiatric disorders (bipolar disorders, psychotic disorders according to dsm-v classification); * major anxiety requiring anxiolytic medication prior to invasive care; * patient under court protection; * patient participating in another study; * patient who has already participated in the dare study. * patient's refusal to use glasses; * visually impaired or blind patient.

Keywords: audiovisual sedation anxiety resuscitation post-operative intensive care invasive care continuous monitoring
clinical trial between laparoscopic gastric bypass and laparoscopic vertical banded gastroplasty for morbid obesity

Conditions: Morbid Obesity

Summary: this is a randomized clinical trial assessing the outcome of two surgical strategies to treat severe obesity; laparoscopic gastric bypass and laparoscopic vbg. main outcome is weight loss and weight loss maintenance but other factors as body composition, eating pattern, metabolic normalisation, energy expenditure will also be assessed.


Eligibility criteria:
inclusion criteria: * bmi 35-50 kg/m2 * 20-60 y exclusion criteria: * severe co-morbidity * unmotivated to long term follow up

Keywords: obesity weight loss surgery gastric bypass vbg