Kornimate/medical-research-clean huggingface dataset:
study of pancreatic enzymes in the drains as early biomarkers of post-operative pancreatic fistula and its clinical repercussions

Conditions: Pancreatic Fistula

Summary: surgery is the principal treatment for benign and malignant pancreatic tumours. this surgery can be accompanied by complications among which the main one is pancreatic fistula, which leads to the flow of pancreatic juices into the abdominal cavity. depending on its severity, a fistula can be managed medically, with the implantation of a la pose d'un percutaneous drain, endoscopic treatment, or revisit surgery. it has been shown that early management of the fistula prevents it from evolving towards major complications such as haemorrhage or serious intra-abdominal infections. to date, the early diagnosis of pancreatic fistula is based on high levels of one pancreatic enzyme, amylase, in the drains. however in certain clinical situations, patients present post-operative fistulas with no elevation of amylase. and, on the contrary, increased amylase with no clinical consequences. it is therefore necessary to identify another early early marker of pancreatic fistula that corresponds better to clinical signs. in a preliminary study conducted in 65 patients, the investigators recently found that another pancreatic enzyme (lipase) could be a more pertinent marker of pancreatic fistula, but this requires confirmation in a greater number of patients. the objective is to evaluate the diagnostic performance of lipase in the drains for the early detection of pancreatic fistula with clinical repercussions in the 30 days following the surgery. the study consists in collecting at 4 different time points (d1, d3, d4 and d6) a tube of blood and a tube of drain liquid.


Eligibility criteria:
inclusion criteria: * patients over 18 * patients undergoing scheduled pancreatic resection with or without anastomosis (cephalic duodenopancreatectomy, median pancreatectomy, left pancreatectomy, enucleation) * patients able to understand instructions/information * patients who have provided written informed consent * patients with health insurance cover exclusion criteria: * patients with scheduled total pancreatectomy * adults under wardship * pregnant or breast-feeding women * total pancreatectomy * pancreatectomy not feasible
pain managment in chronic shoulder pain

Conditions: Chronic Pain Management

Summary: the purpose of this study is to evaluate the effect of adding pulsed radiofrequency (prf) modality to suprascapular nerve injection with ultrasound glenohumeral steroid in chronic shoulder pain patients focusing on both changes in pain and function scores

shoulder pain is the second most prevalent musculoskeletal condition in adults which is frequently treated poorly and results in chronic pain . the use of steroid injection has been demonstrated to be superior to conventional therapies, particularly non-steroidal anti-inflammatory drugs. its impact is transient (4-6 weeks) and occasionally may not be clinically sufficient . an alternate analgesic injection for the pain management of numerous shoulder diseases is the suprascapular nerve block (ssn) . although pulse radiofrequency analgesia typically lasts for a much longer period than nerve blocking, it has become increasingly popular to apply pulse radiofrequency to peripheral nerves.

Eligibility criteria:
inclusion criteria: * adults aged from 21-60 years. * patients with american society of anesthesiologists (asa) physical status i and ii. * chronic shoulder pain (\>3 months) and will undergo interventional treatment due to inadequate response to conservative treatments. exclusion criteria: * refusal of procedure or participation in the study by patients. * history of shoulder surgery, another intervention history between 3 months before and 1 year after the intervention applied. * patients with chronic pain syndrome due to other shoulder pathology (fibromyalgia, cervical discopathy, brachial plexus injury). * uncontrolled diabetes mellitus patients with glycated hemoglobin (hba1c) levels of more than 7%. * patients with known history of allergy to the study drugs. * infection at site of injection. * cognitive or psychiatric illness that will lead to inability to cooperate, speak, or provide informed consent.

Keywords: shoulder pain suprascapular nerve block pulsed radiofrequency
low dose radiotherapy for covid-19 pneumonitis

Conditions: Covid19

Summary: sars-cov-2 is causing an unprecedented stress on healthcare systems around the world, due to its high rate of infection and the high morbidity and mortality. the covid-19 infection triggers an inflammatory cascade with cytokine synthesis, prompting the immune response. low dose radiotherapy (ld-rt) (≤ 100 cgy) induces an anti-inflammatory response, lowering levels of pro-inflammatory cytokines such as il-1β or inhibit leukocyte recruitment. ld-rt has been used historically for the pneumonia treatment reporting a rapid clinical improvement (within the first week), as well as a reduced mortality (from around 30% to 10%). considering these results, ld-rt can potentially afford a therapeutic benefit against sars-cov-2. the study purpose is to evaluate prospectively the safety and efficacy of ld-rt for sars-cov-2.


Eligibility criteria:
inclusion criteria: 1. age ≥ 60 years. 2. covid19 + confirmed by pcr. 3. thoracic imaging study (chest x-ray, chest ct or pet-ct), compatible with lung involvement. 4. phase ii or lung phase without any improvement with pharmacological treatment. 5. phase iii or hyper-inflammatory phase without any improvement with pharmacological treatment 6. poor clinical and functional respiratory evolution: \> 30 breaths / minute, spo2 \<93%, pao2 / fio2 \<300. 7. d-dimer\> 1000 ng / ml or rising, ferritin\> 1000 ng / ml, pcr\> 10 mg / dl or double than before. exclusion criteria: 1. severe comorbidities that could hamper the radiation treatment.

Keywords: radiotherapy antiinflammatory pneumonitis
comparison of the efficacy and safety of cresnon® and crestor® in patients with hyperlipidemia

Conditions: Hyperlipidemia

Summary: comparison of the efficacy and safety of cresnon® and crestor® in patients with hyperlipidemia - 8-week, active-controlled, open-label, randomized, parallelgroup, fixed-dose, noninferiority, multicenter, phase 4 design


Eligibility criteria:
inclusion criteria: * age ≥ 20 * persons who have not reached ldl-c targeted level in accordance with the treatment guidelines for dyslipidemia released by korean society of lipidology and atherosclerosis
safety study of black cohosh use by postmenopausal women on the liver

Conditions: Menopause

Summary: black cohosh extract is a form of phytoestrogen (estrogen of plant origin) that is effective in controlling bothersome hot flushes, while avoiding the dangers of using hormones. recent case reports pointed to potential toxicity of black cohosh on the liver. the investigators are trying to verify or refute such allegations.

the aim of this prospective longitudinal clinical trial is to evaluate changes in total hepatic blood flow and liver functions among postmenopausal women using black cohosh (cimicifuga racemosa) extract for twelve consecutive months for relief of vasomotor symptoms. prior to using a daily dose of 40 mg of a dry extract preparation of cimicifuga racemosa (klimadynon®) and twelve months after, total hepatic blood flow will be assessed by color doppler ultrasound. moreover, prothrombin time \& concentration, serum albumin, bilirubin, gamma-glutamyl transferase (ggt), alkaline phosphatase (alp), alanine aminotransferase (alt) and aspartate aminotransferase (ast) will also be measured.

Eligibility criteria:
inclusion criteria: * an age over 40 years * with a lapse of one year after the last menstruation * symptomatic women without gynecological illness * after naturally occurring menopause * had never used hormonal therapy or had stopped using them for \>6 months * accepting to participate after receiving adequate description of the study * accessible for regular follow-up. exclusion criteria: * vaginal bleeding * active or chronic liver disease and /or abnormal liver functions * present or past thromboembolic disease * present or past neoplasia of the breast or uterus * an endometrial thickness \>5 mm by tvs * use of alternative or complementary medicines or herbs for menopausal symptoms within the previous three months

Keywords: cimicifuga racemosa liver blood flow and functions
montelukast with status asthmaticus, ages 2-5

Conditions: Status Asthmaticus; Asthma

Summary: the purpose of this study is to determine if montelukast, in addition to standard treatment is helpful in treating patients ages 2-5 who are in the hospital because of status asthmaticus.

this is a prospective study of montelukast efficacy in addition to standard treatment of status asthmaticus in children from 2-5 years old who are in the picu. children who meet eligibility requirements will be randomized to receive a rapid-dissolving oral dose of montelukast or placebo. once enrolled, a baseline modified wood's-downes clinical asthma severity score will be recorded pre and post completion of a standard nebulized albuterol treatment of 0.15 mg/kg/dose (min2.5mg/dose). patients who are able will have fev1 measurements obtained at predetermined intervals for determination of clinical asthma severity score. blood samples for pk analysis will be collected prior to study drug administration and at predetermined time intervals to determine the plasma level of montelukast. in addition, a blood sample will be obtained for genetic study of polymorphisms of cyp3a4, cyp3a5, and cyp2c9.

Eligibility criteria:
inclusion criteria: * participant's parent/legal guardian must give written informed consent prior to study participation. when appropriate, written assent from the child will also be obtained. * participant, male or female, must be 2 to 5 years of age. * participant must have a history of reactive airway disease (rad) or asthma, and must currently be admitted for an acute exacerbation of rad or asthma. * primary physician must believe that patient would benefit from improved bronchodilation and improvement in clinical asthma severity score. * participant must have received standard therapy for status asthmaticus: oxygen as needed; 3 nebulized albuterol treatments of at least 2.5mg/dose; methylprednisolone or prednisone loading dose of 2mg/kg; ongoing methylprednisolone therapy @ 0.5mg/kg every 6 exclusion criteria: * known hypersensitivity to montelukast * chronic lung disease * cardiac or pulmonary congenital anomalies * known renal disease * known hepatic disease * known immunologic disorders other than allergy and atopy * other explanations for respiratory distress * use of leukotriene modifiers within 2 weeks of the acute presentation * intubated patients

Keywords: montelukast albuterol status asthmaticus asthma
gene expression in predicting response to paclitaxel in patients with breast cancer

Conditions: Breast Cancer

Summary: rationale: dna analysis of tumor tissue may help doctors predict how patients who receive paclitaxel will respond to treatment. purpose: this laboratory study is evaluating gene expression in predicting response to paclitaxel in patients with breast cancer.

objectives: * determine whether loss of function of the fez1/lzts1 gene is a predictor of response in patients with breast cancer treated with paclitaxel. outline: this is a single-blind study. tumor tissue is analyzed for fez1/lzts1 gene expression by immunohistochemistry using an antibody for the gene. tumor expression of the gene is characterized by immunohistochemistry and scored by intensity of staining, percent of cell staining, and staining index. tumor tissue is also analyzed for fez1/lzts1 gene disruption by reverse transcriptase-polymerase chain reaction and direct sequencing. projected accrual: approximately 120 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of breast cancer * measurable disease * metastatic disease identified by imaging studies or a primary disease site that will be treated in a neoadjuvant protocol * lesions ≥ 10 mm by spiral ct scan * tumor tissue from the primary or metastatic site available for analysis by immunohistochemistry * previously treated or planning to undergo treatment with paclitaxel\* note: \*concurrent enrollment on ecog-2100 allowed * hormone receptor status: * not specified patient characteristics: * not specified prior concurrent therapy: * see disease characteristics

Keywords: stage i breast cancer stage ii breast cancer stage iiia breast cancer stage iiib breast cancer stage iiic breast cancer stage iv breast cancer recurrent breast cancer
non-invasive screening for fetal aneuploidy

Conditions: Down Syndrome; Edwards Syndrome

Summary: the purpose of this study is to determine if a laboratory test developed by the sequenom center for molecular medicine (scmm) that uses a new marker found in the mother's blood can better identify pregnancies that have a child with a chromosome abnormality such as down syndrome (trisomy 21), edwards syndrome (trisomy 18), or other chromosome abnormality.


Eligibility criteria:
inclusion criteria: * subject is willing to provide written informed consent * pregnant female with singleton gestation 18 years of age or older * subject agrees to provide a 20 to 30 ml venous blood sample * subject is one of the following: a) currently scheduled to undergo an amniocentesis and/or cvs procedure, or b) currently in the first trimester of pregnancy and planning to undergo an amniocentesis in the second trimester * subject will receive results of a genetic analysis that includes evaluation of the fetus for aneuploidy exclusion criteria: * subject lacks the capacity to provide informed consent * twins, triplets or other multiple gestation

Keywords: down syndrome aneuploidy chromosome abnormality amniocentesis chorionic villus sampling laboratory developed test (ldt)
preventive regimens with herbal and fluoride toothpaste on remineralization in high caries patients with initial lesions

Conditions: Dental Caries

Summary: this study will be conducted to assess the effect of different preventive regimens using herbal toothpaste versus fluoride toothpaste on the management of remineralization and caries risk in high caries risk patients.

dental caries is a major universal health problem with multiple etiological factors, so looking for economical and accurate plans for recognizing high-risk persons, and multiple risk factors to reduce the risk, in addition to caries management, using a caries risk assessment to detect the person who will develop caries, and provide them with suitable preventive and treatment regimens to disruption the disease procedure. the treatment should evade invasive treatments and a large emphasis on prevention (using fluoride toothpaste, solutions, patient education, and so on), to achieve the aim of new dentistry (minimal intervention). the application of such a regimen to manage initial caries lesions allows the dentist to reverse initial lesions with the minimal victim of healthy dental tissues.

Eligibility criteria:
* inclusion criteria of the participants: 1. healthy patients with free medical history. 2. age range 15-50 years. 3. patients with high caries risk assessment according to cariogram. 4. patients with initial carious lesions at the facial surface of any teeth 5. high plaque index 6. not under antibiotic therapy either at the time of the study or up to the last month before the start of the study * exclusion criteria of the participants: 1. patients with a compromised medical history. 2. patients with dentin caries 3. extreme plaque accumulation and periodontal problems 4. completely edentulous patients 5. participants with a history of allergy to any of the drugs or chemicals used in the study. 6. patients on any antibiotics during the past month * inclusion criteria of the teeth: 1. the wsls with lf measurements inside the range 14-20 were involved in this study. 2. the lesions with scoring either 2 or 3 according to (icdas) scoring were included in the study * exclusion criteria of the teeth: 1. the white spot lesion scoring is (\ 20) according to diagnodent 2. the white spot lesion scoring is other than 2, 3 according to icdas 3. white spot lesions due to hypomineralization or fluorosis
study to determine the effectiveness and safety of a three drug antiviral combination therapy to treat hepatitis c virus (hcv) infected patients not previously treated with currently available medications

Conditions: Chronic Hepatitis C

Summary: the purpose of this study is to estimate the rate of sustained virologic response (svr) svr12, where svr12 is defined as hcv rna \< loq (detectable or undetectable) 12 weeks post-treatment in genotype 1 \& genotype 4 treatment naive patients, and genotype (gt1) infected patients who are prior null responders to pegifn/ribavirin

ind numbers: 79,599; 101,943

Eligibility criteria:
inclusion criteria: * men and women, ages ≥18 years of age * subjects who are naive to hcv treatment, defined as no previous exposure to an interferon (ifn), ribavirin (rbv); or any hcv-specific direct acting antiviral or experimental therapy or subjects who are null responders to previous pegylated interferon alfa (pegifnα) plus ribavirin (rbv) treatment * subjects should have chronic hepatitis c (chc) as documented by: 1. positive for anti-hcv antibody, hcv rna, or a positive hcv genotype test at least 6 months prior to screening, and positive for hcv rna and anti-hcv antibody at the time of screening, or 2. positive for anti-hcv antibody and hcv rna at the time of screening with a liver biopsy consistent with chronic hcv infection (or a liver biopsy performed prior to enrollment with evidence of chc disease, such as the presence of fibrosis) * hcv genotype 1a, 1b or 4 only * hcv rna viral load of ≥10,000 iu/ml at screening * have one of the following: 1. documented fibrotest score of ≤0.72 and aspartate transferase (transminase) to platelet ratio index (apri) ≤2; or 2. documented liver biopsy within 36 months preceding day 1 showing absence of cirrhosis or 3. documented fibroscan® ultrasound (where approved) within 12 months of screening showing absence of cirrhosis * body mass index (bmi) of 18.0 to 35.0 kg/m2, inclusive * subjects with compensated child-pugh a cirrhosis as documented by history of cirrhosis with any prior liver biopsy or fibroscan® ultrasound (where approved) within 12 months prior to screening exclusion criteria: * evidence of a medical condition associated with chronic liver disease other than hcv (such as but not limited to: hemochromatosis, autoimmune hepatitis,metabolic liver disease, alcoholic liver disease, toxin exposures) * history of variceal bleeding, hepatic encephalopathy, or ascites requiring management with diuretics or paracentesis * current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment * documented or suspected hepatocellular carcinoma (hcc) * positive for hepatitis b surface antigen (hbsag) * positive for human immunodeficiency virus-1 (hiv-1) and/or human immunodeficiency virus-2 (hiv-2) antibodies * alanine transferase (transminase) (alt) \>5x upper limit of normal (uln) * total bilirubin ≥2 mg/dl
effect of spasticity on tibial nerve entrapment

Conditions: Neuropathy; Stroke

Summary: stroke is the most common cause of mortality and is one of the most common causes of morbidity in the world. polyneuropathies and entrapment neuropathies are known as the complications of stroke


Eligibility criteria:
inclusion criteria: * 1- a hundred patients with hemiplegia /paresis subsequent to a stroke as diagnosed by ct or mri. 2- a hundred patients from both sexes, their ages ranged from (55-65) years. 3- body weight of patients was ranged from(55 -95 kg) ,while their height was from (151-185 cm) and bmi was ranged from (20-30 kg/m2). 4- duration of illness (6 - 9 months post stroke). 5- patients have spasticity ranging from grade 1 to grade 3 according to modified ashworth scale 6- patients were medically stable exclusion criteria: * 1- patients with lumbosacral sciatica that could mimic tts or interfere with its evaluation 2- patients with tibial neuropathy, significant polyneuropathy, or marked orthopedic abnormalities; 3- patients with contractures 4- patients with psychological disturbance or seizures 5- systemic diseases known to cause tts, such as diabetes mellitus, hypothyroidism, rheumatoid arthritis, or chronic renal failure;
optimizing cerebral autoregulation during surgery

Conditions: Hip Fractures; Hip Arthropathy; Surgery; Delirium

Summary: the purpose of this study is to conduct a pilot trial to determine the feasibility, safety, and potential efficacy of targeting mean arterial blood pressure (map) within the limits of cerebral autoregulation during surgery compared with usual care.


Eligibility criteria:
inclusion criteria: * planned hip or knee surgery (either for fracture or elective) or lung surgery * age ≥60 * ambulatory at baseline * expected duration of surgery \> 90 minutes exclusion criteria: * planned concurrent surgery * allergy to adhesive tape * short blessed test score \>20 * clinical diagnosis of dementia * opinion of either the anesthesiologist or surgeon that the patient is not appropriate.
digital cognitive-behavioral therapy for insomnia: a randomized controlled trial

Conditions: Insomnia

Summary: the study investigates whether online cognitive-behavioral therapy for insomnia is as effective as the standard in-person group treatment, using clinical and sleep-related outcomes in adult patients.

this study aims to evaluate the effectiveness of digital cognitive behavioral therapy for insomnia (dcbt-i) in italian, comparing it to the traditional face-to-face group-based cbt-i. sixty adults with chronic insomnia will be randomized to one of the two interventions, with assessments conducted pre- and post-treatment through validated questionnaires and objective sleep monitoring.

Eligibility criteria:
inclusion criteria: * diagnosis of chronic insomnia individuals aged 18 to 75 years signed informed consent form (icf) prior to study participation exclusion criteria: * diagnosis of comorbid sleep disorder (e.g. obstructive sleep apnea) diagnosis of mental disorder in comorbidity physical problems that may alter and dysregulate sleep pregnancy and breastfeeding

Keywords: sleep insomnia cognitive-behavioral therapy for insomnia