Kornimate/medical-research-clean huggingface dataset:
a study of avastin (bevacizumab) and fotemustine in patients with recurrent glioblastoma

Conditions: Glioblastoma Multiforme

Summary: this randomized, non-comparative study will evaluate the efficacy and safety of avastin (bevacizumab) in patients with recurrent glioblastoma. patients will be randomized to receive avastin 10 mg/kg intravenously every 2 weeks or fotemustine 75 mg/m2 on days 1, 8 and 15, followed by, after a 5 weeks interval, 100 mg/m2 intravenously every 3 weeks. treatment with fotemustine serves as a calibration arm and no formal efficacy comparison will be made between the two treatment arms. the anticipated time of study treatment is until disease progression or unacceptable toxicity.


Eligibility criteria:
inclusion criteria: * adult patients, \>/=18 years of age * diagnosis of recurrent glioblastoma multiforme (grade iv) * previous treatment with temozolomide and radiotherapy * first recurrence after standard adjuvant treatment (surgery, followed by radiotherapy and chemotherapy) * adequate hematological, biochemical and organ functions exclusion criteria: * previous treatment with avastin or other anti-angiogenic drugs * residual relevant toxicity resulting from previous therapy * radiotherapy within the 3 months prior to the diagnosis of disease progression * chemotherapy in the previous 4 weeks * other active or inactive malignancies (except for carcinoma in situ of the cervix, of the prostate or basal cell carcinoma) * clinically significant cardiovascular diseases
autologous neo-bladder construct in non-neurogenic overactive bladder and urge predominant incontinence

Conditions: Overactive Bladder

Summary: subjects with non-neurogenic over-active bladder will be enrolled. the hypothesis is that augmentation cystoplasty using an autologous neo-bladder construct will increase functional capacity and thereby reduce the number of micturition episodes per day in subjects with non-neurogenic over active bladder and urge predominant incontinence.

subjects with non-neurogenic over-active bladder and urge predominant incontinence who are intolerant to medical therapy or have persistence of symptoms despite medical therapy and require augmentation cystoplasty will be enrolled. the hypothesis is that augmentation cystoplasty using an autologous neo-bladder construct will increase functional capacity and thereby reduce the number of micturition episodes per day in subjects with non-neurogenic over active bladder and urge predominant incontinence.

Eligibility criteria:
inclusion criteria: * history of non-neurogenic overactive bladder for at least 12 months prior to study entry * intolerance to medical therapy or persistence of symptoms despite medical therapy exclusion criteria: * subjects with stress incontinence or mixed incontinence where the predominant component is stress incontinence * use of botulinum toxin a injections into the bladder within the previous 6 months * presence of a neuromodulator * using catheterization as a way to control incontinence * history of bladder cancer

Keywords: non-neurogenic over active bladder urge predominant incontinence
fats and carbohydrates quality on postprandial glycemic response in type 1 diabetes

Conditions: Type 1 Diabetes

Summary: the purpose of this study is to determine whether dietary fats may affect postprandial glycemic response differently according to their quality, and these effects may differ whether they are assumed in the context of meals with high or low glycemic index in patients with type 1 diabetes. this interaction between quality of fat and glycemic index of carbohydrates may have clinical implication for the calculation of prandial insulin dose in these patients.


Eligibility criteria:
inclusion criteria: -type 1 diabetes treated by insulin pump exclusion criteria: * pregnancy * celiac disease

Keywords: postprandial glycemia momounsaturated fatty acids saturated fatty acids glycemic index glycemic load sensor augmented pump system
preoperative chemoradiation with vmat-sib in rectal cancer

Conditions: Rectal Neoplasms

Summary: this was a prospective phase ii study on patients with locally advanced rectal cancer or local recurrence, to evaluate the pathological response and resectability of a neoadjuvant treatment based on the use of a combined treatment with vmat-sib and two drugs chemotherapy ( xelox).

this was a prospective phase ii study on patients with larc or local recurrence, to evaluate the pathological response and resectability of a neoadjuvant treatment based on the use of a combined treatment with vmat-sib and two drugs chemotherapy ( xelox). the primary aim was to asses the pathological response rate. key secondary aim was the acute toxicity. secondary aims were local control, disease-free survival (dfs) and overall survival (os). the follow-up period of each subjects started at the end of combined treatment and concluded after a period of maximum 60 months or until death.

Eligibility criteria:
inclusion criteria: i) histologically proven rectal adenocarcinoma (ct3-4n0-2 or ct2n1-2 or locally recurrent) beginning within 12 cm from the anal verge; ii) age ≥ 18 years; iii) eastern eastern cooperative oncology group (ecog) performance status of 0-2. exclusion criteria: i) history of chemotherapy and/or pelvic radiotherapy; ii) previous treatment with immunotherapy; iii) metastatic patient; iv) presence of active intestinal inflammation or uncontrolled pelvic inflammation; v) pregnant and/or breastfeeding patient.

Keywords: rectal cancer radiotherapy chemotherapy vmat toxicity
two-channel intravenous patient-controlled analgesia (iv-pca) after total laparoscopic hysterectomy (tlh)

Conditions: Total Laparoscopic Hysterectomy; Patient-controlled Analgesia

Summary: the purpose of this study is to compare the dual channel intravenous patient-controlled analgesia (iv-pca) with single channel elastomeric pump (only one channel of dual channel pump is used for blinding and the other channel is filled with same volume of saline) in patients undergoing total laparoscopic hysterectomy, in terms of quality of recovery, efficacy of postoperative pain, drug consumption, adverse event, and patient subjective satisfaction.

the bellomic® m silicone balloon infuser, dual continuous petite type (cebika, uiwang-si, gyeonggi-do, republic of korea) is a newly designed iv-pca device that is a 2-channel infusion elastomeric pump with two balloon chambers. conventional elastomeric iv-pca devices were administered with a mixture of drugs in one chamber; when severe opioid related side effects occur, the iv-pca administration is suspended by clipping, in this situation, not only the analgesic effect of opioid but also the effect of adjuvants could not be applied. on the other hand, this newly designed device can be controlled as needed by administering adjuvant analgesics or antiemetic agents through another adjustable chamber. it will be expected that facilitate the pain management and increased the patient satisfaction and recovery.

Eligibility criteria:
inclusion criteria: * patient who was scheduled to undergo elective tlh under general anesthesia, was a female aged 19-75 years, and had an american society of anesthesiologists physical status i-ii exclusion criteria: * body mass index \> 30.0 kg/m2, known hypersensitivity to the drugs used in this study, significant liver or renal dysfunction, or a history of drug abuse or dependence, recent major procedure or surgery, or preoperative analgesic use
epithelium-on corneal cross-linking in subjects 8 to 45 years of age with keratoconus

Conditions: Keratoconus

Summary: a multicenter, randomized, double-masked, sham-controlled, parallel-group phase 3 study to evaluate the efficacy and safety of epithelium-on corneal cross-linking in subjects 8 to 45 years of age with keratoconus


Eligibility criteria:
inclusion criteria: * diagnosis of keratoconus exclusion criteria: * minimal corneal thickness \< 350 microns * non-keratoconic ectatic disease * contraindications or hypersensitivities to any required study medications * pregnancy or breastfeeding * certain concomitant ocular conditions
metacognitive therapy for patients with obsessive-compulsive disorder

Conditions: Obsessive-Compulsive Disorder

Summary: cognitive behavior therapy is the most effective treatment of obsessive-compulsive disorder. however, the majority of treated patients remain symptomatic. the metacognitive therapy by wells (1997) could achieve substantial gains in first pilot studies. the purpose of this study is to investigate this approach with a randomized controlled trial by comparing metacognitive therapy with exposure and response prevention for obsessive-compulsive disorder.


Eligibility criteria:
inclusion criteria: * primary diagnosis: obsessive-compulsive disorder * german-speaking * agreeing to participate, verified by completion of informed consent exclusion criteria: * current or past diagnosis of substance dependence, psychosis, neurological conditions * mental retardation
diagnostic performance of urinary gluten immunogenic peptides in monitoring the adherence to gluten-free diet.

Conditions: Celiac Disease

Summary: the purpose of the grres study is to assess the clinical usefulness of urinary gluten immunogenic peptides test as a marker of gluten-free diet adherence using the rapid immunochromatographic assay based on anti-gliadin 33-mer monoclonal antibodies.

a strict and permanent gluten free diet (gfd) is the only effective treatment resulting in full clinical, serological and histological remission, avoiding long-term complications in celiac disease (cd) patients. gluten immunogenic peptides (gip) are fragments of gluten proteins resistant to gastrointestinal digestion and detectable in urine after intestinal digestion, providing direct evidence of recent gluten ingestion. a significant variability in the amount of excreted urinary gip has been reported in individuals administered with similar doses of gluten and, so far, inadequate information is available about the amount of excreted gip in subjects ingesting traces or low amount of gluten. this is an important issue, as even a strict gfd could be contaminated by traces of gluten, e.g. in wheat starch and processed food. the aim of this study is to assess the clinical usefulness of urinary gip as a marker of gfd adherence using a rapid immunochromatographic assay based on anti-gliadin 33-mer monoclonal antibodies. this is a prospective, randomized, triple-blind, placebo-controlled, clinical trial. in this study, healthy volunteers following a normal diet will be requested to be on strict gfd for 5 days. on day 4th, participants will be requested to collect a baseline urine sample and in case of a negative gip test result they will be assigned to ingest a specific dose of purified gluten incorporated in a capsule (0 mg, 10 mg, 50 mg, 100 mg, 500 mg and 1000 mg, according to randomization). participants will be requested to collect urine samples in a container and take a 5 ml aliquote for the gip test at the 9th and 24th hour from the time of the administration of the dose. during the collection, volunteers will also be requested to record the volume of the excreted urine and to store the collected urine at 4°c. urine tubes will be stored at -20°c until the quantitative evaluation of gip. gip test will be performed using the rapid immunochromatographic assay based on anti-gliadin 33-mer monoclonal antibodies ivycheck gip urine™ test (biomedal, spain) according to the manufacturer's instructions.

Eligibility criteria:
inclusion criteria: * healthy volunteers * 20-40 years old * written informed consent exclusion criteria: * type 1 diabetes * chronic or acute inflammatory diseases of the gastrointestinal tract (cd, non-celiac gluten sensitivity, crohn's disease, ulcerative colitis, food allergy, acute gastroenteritis ≤ 4 weeks prior to the study start) * pregnancy or lactation * chronic intake of medications and supplements * refusal/withdrawal of written informed consent.

Keywords: gluten-free diet gluten immunogenic peptides gluten contamination gluten urine
pectoral nerves block to relieve post-sternotomy pain after cardiac surgery

Conditions: Pain, Postoperative; Cardiac Surgery

Summary: the primary objective of this study is to determine if the addition of pecs2 block provides superior post-operative analgesia for cardiac surgery patients after midline sternotomy compared to only standard-of-care post-operative pain medication.

the current study is a prospective, double-blind study investigating the use of pectoral nerves (pecs) block 2 to alleviate post-operative pain in cardiac surgery patients. the investigators anticipate enrolling a total of 220 participants in one of two groups, an interventional pecs block group and a control group not receiving the block. the intervention will occur in the operating room after the completion of the cardiac procedure and prior to the transfer of the participants to the cardiothoracic intensive care unit (cticu). both groups will receive the standard-of-care (soc) pain regimen; the intervention with receive the pecs block in addition to soc pain regimen. the procedure takes approximately five to ten minutes and will be conducted by the attending cardiac anesthesiologist. pain will then be monitored hourly in the post-operative period in the cticu. additional measures will be investigated that are regularly logged in the electronic medical record.

Eligibility criteria:
inclusion criteria: 1. obtaining one or more of the following elective surgical procedures at nyu winthrop hospital with midline sternotomy: * coronary artery bypass graft (any number of vessels) * aortic valve replacement (avr) * aortic valve repair * mitral valve replacement (mvr) * mitral valve repair * tricuspid valve replacement * tricuspid valve repair * pulmonic valve replacement * pulmonic valve repair * congenital heart defect repair * ascending thoracic aortic aneurism repair * patient age \> 18 years. 2. willingness and ability to participate in the study procedures 3. sufficiently hemodynamically stable to give consent exclusion criteria: an individual who meets any of the following criteria will be excluded from participation in this study: * hemodynamic instability * preexisting infection at site of block * allergy to block agents * severe psychiatric illness * intubated emergently prior to reception by the perioperative team * patient is preoperatively on extracorporeal membrane oxygenation (ecmo) treatment. * pregnant patient * recent surgery
phase 1 study to evaluate rdc-0313 coadministered with buprenorphine to opioid-experienced healthy adults

Conditions: Substance-Related Disorders

Summary: this is a single site, double-blind, randomized, placebo-controlled, crossover study to assess the pharmacodynamics (pd) of rdc-0313 coadministered with buprenorphine in 12 healthy, opioid-experienced, non-treatment-seeking subjects.


Eligibility criteria:
inclusion criteria: * subject must be capable of understanding and complying with the protocol and has signed the informed consent * must be 18-55 years of age * must have a body mass index of 18.0-30.0 kg/m2 at screening * female subjects must agree to use an acceptable method of contraception from date of consent and until two weeks after the last dose * subjects must be willing not to use alcohol-, tobacco, caffeine-, or xanthine-containing products while resident at inpatient facility * subjects must be an experienced opioid user who meets the following criteria: 1) has used opioids for non-therapeutic purposes (ie, for psychoactive effects) on at least 10 occasions in the past five years; 2) has used opioids at least 2 times in the two years prior to screening; and 3) is not physically dependent on opioids, as assessed by medical history and naloxone challenge performed at screening exclusion criteria: * must not have any current or piror significant hepatic, renal, endocrine, cardiac, nervous, psychiatric, gastrointestinal, pulmonary, hematologic, or metabolic disorders. * must not have current or past opioid, alcohol, or other durg dependence (excluding nicotine and caffeine) or showing signs of withdrawal following the naloxone (narcan) challenge. * please contact site for additional information about other exclusion criteria.
the prospect of using serum taurine level as a potential biomarker for early detection of colorectal carcinoma and its correlation with other prognostic markers

Conditions: Taurine in Cancer Colon

Summary: serum taurine results in this study showed that, besides crc biomarkers; it is most attractive, more precious and more accurate early biomarker for early detecting of any malignant change which may led to crc by other mean it is the most sensitive and more specific tumor marker for crc. as a result, we can recommend measuring its level regularly with other prognostic tumor biomarkers and screening examination for all people with abdominal and gastrointestinal problems and for precancerous patients as a pre-early biomarker for colorectal carcinoma. so, it needs further studies to confirm that observations on large scale of population as it obvious the small sample size in early stage and lack data due to limited financial resources and it needs more efforts to collect first and precancerous stages patients.

two-hundred and fifty egyptian patients (males and females) who attended national cancer institute, cairo university; most of them were referred from private clinics and non-specialized hospitals, complain with abdominal troubles and gastrointestinal problems and bleeding per rectum, after full investigation, clinical examination, biochemical analysis, screening examination according to their cases (ultra sound, ct or endoscopy either rectal or colonoscopy) and histopathological examination, we choose 'after their approval' one-hundred patients and six which diagnosed as crc patients aged (19-69 years old) and excluded the others from participated in these studies because they diagnosed as non-colonic diseases like; irritable colon, gastroenteritis, pancreatitis, liver flexure or chronic cholecystitis. according to histopathological architecture, we divided patients to: 1. inflammatory group number=7. 2. benign tumor group number=8 which was assessed preoperatively and postoperatively. 3. malignant tumor group number=91 lastly, ten health volunteers were enrolled as a frank control. for all included subjects, the measured biochemical analysis were cbc, alt, ast, albumin, total bilirubin, creatinine, blood urea, sodium, potassium, cea, ca19.9 and taurine.

Eligibility criteria:
inclusion criteria: patients complain of abdominal troubles and gastrointestinal problems and bleeding per rectum exclusion criteria: patients refusal,non-colonic diseases like; irritable colon, gastroenteritis, pancreatitis, chronic cholecystitis
intravitreal ranibizumab versus its combination with dexamethasone in the treatment of diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: intravitreal ranibizumab alone was compared to adding dexamethasone to ranibizumab regarding central macular thickness, the visual acuity and the number of intravitreal injections needed to achieve the same effect on cmt and bcva at the end of the 6 months duration of the study. any significant change in final iop, compared to baseline, in either group is reported.

this prospective randomized study measures the changes in central macular thickness, best corrected visual acuity and iop in diabetic macular edema before and after the intravitreal injection of ranibizumab and dexamethasone, compared to ranibizumab alone, the current gold standard of care for diabetic macular edema. study participants were randomized into 2 groups: the first group received 3 intravitreal injections of ranibizumab alone 1 month apart. while the second group received 1 intravitreal injection of a combination of ranibizumab and 0.4 mg in 0.1 ml dexamethasone followed by 2 intravitreal ranibizumab, 1 month apart (with dexamethasone if follow up oct shows less than 10% improvement from baseline). treatment was stopped when the treated eye achieved a central macular thickness of 250 microns or less with no focal parafoveal edema. final recorded central macular thickness in both groups compared to the baseline. by the end of the follow up period. final visual acuity was assessed in both groups compared to the baseline change in final iop, compared to baseline, in ranibizumab group and ranibizumab with dexamethasone group. . the number of injections needed to achieve the same effect on cmt and bcva.

Eligibility criteria:
inclusion criteria: * diabetic macular edema with central macular thickness of 300 μm or greater (as measured by spectral domain optical coherence tomography \[oct\]). * best corrected visual acuity of 6/12 or less. exclusion criteria: * ● history of any treatment for dme (including grid or focal laser photocoagulation) within the last 6 months * history of panretinal photocoagulation within the last 6 months. * pdr as indicated with fluorescein angiography as it will require prp which may affect dme. * macular ischemia, as indicated with fluorescein angiography. * cataract surgery within three months or cataract that requires surgical intervention during the follow-up period. * pseudophakia with irvine gass syndrome, as indicated with fluorescein angiography. * vitreomacular traction syndrome. * other causes of macular edema (eg. crvo, cnv, uveitis, etc). * glaucoma, whether suspected or confirmed. * significant media opacity. * patients with ocular or periocular infections, or infection in the other eye * signs of active or resolved uveitis and intraocular inflammation. * bad diabetic control as indicated by hba1c \>8. * renal impairment, hepatic impairment, or congestive heart failure. * history of cardiovascular insult or stroke.
the role of smoking and gingival crevicular fluid markers on coronally advanced flap outcomes

Conditions: Gingival Recession; Smoking

Summary: cigarette smoking is a patient-related factor that can affect healing of periodontal tissues and the success rate of root-coverage procedures. neither the nature nor the mechanisms of action of cigarette smoking on root coverage are fully understood. therefore, the hypothesis that cigarette smoking has negative impacts on the outcomes of root coverage after caf surgery in systemically healthy individuals with an initial gingival thickness of at least 0.8 mm and who practice optimal oral hygiene was tested. it was also hypothesized that baseline analysis of disease-related biomarkers would shed light on the underlying mechanisms of a possible effect.


Eligibility criteria:
inclusion criteria: * maxillary central and lateral incisors, canines, and premolars and mandibular premolars with isolated buccal recessions classified as miller class i or ii * study tooth should present tooth vitality, identifiable cemento-enamel junction (cej) and absence of caries, restorations or extensive non-carious cervical lesion. exclusion criteria: * medical disorders such as diabetes mellitus, immunologic disorders, hepatitis * history of previous mucogingival surgery at the gingival recession site * medications known to affect gingival tissues * antibiotic treatment in the past 6 months * pregnancy or lactation

Keywords: gingival crevicular fluid gingival recession saliva smoking wound healing
sickle cell anemia in an arab bedouin village in the northern israel

Conditions: Sickle Cell Disease

Summary: sickle cell anemia and sickle cell thalassemia are frequent diseases among the israeli arab population. the purpose of this study is to assess the clinical characteristics of the patients in one arab village and the laboratory characteristics in the carriers of this gene based in the screening for pregnant women that is carried out in the population of northern israel. the results can be useful in order to institute universal screening for sickle cell anemia in northern israel.


Eligibility criteria:
inclusion criteria: * all the patients that were diagnosed as having sickle cell disease in the specific village and all the population screened for hemoglobinopathies in the same location

Keywords: sickle cell disease sickle cell thalassemia population screening