Kornimate/medical-research-clean huggingface dataset:
erector spinae plane block and subcostal transverse abdominis plane block in laparoscopic cholecystectomy

Conditions: Postoperative Pain

Summary: erector spinae plane block is a newly defined regional anesthesia technique. its use for many indications has been identified by case reports in the literature. as the investigators have considered that erector spinae plane block could be efficacious for providing postoperative analgesia in laparoscopic cholecystectomy, the investigators have implemented the application of this blockade into practice at the clinic subcostal transverse abdominis plane block (stap) is another regional anesthesia technic used for postoperative analgesia in laparoscopic cholecystectomy. main purpose of this study is to compare the analgesic effect of ultrasound-guided erector spinae block and stap in laparoscopic cholecystectomy.


Eligibility criteria:
inclusion criteria: * asa i-ii-iii * undergoing elective laparoscopic cholecystectomy exclusion criteria: * obesity * asa iv * infection of the skin at the site of needle puncture area * patients with known allergies to any of the study drugs * coagulopathy * recent use of analgesic drugs * inability to provide informed consent * severe kidney or liver disease * inability to operate pca system * patient with psychiatric disorders
a study to assess clbr001+swi019 in subjects with autoimmune diseases

Conditions: Systemic Lupus Erythematosus (SLE); Systemic Sclerosis (SSc); Idiopathic Inflammatory Myopathy (IIM)

Summary: the goal of this clinical trial is to evaluate clbr001 and swi019 as a treatment for patients with autoimmune disorders, including systemic lupus erythematosus, systemic sclerosis, and idiopathic inflammatory myositis. patients will be randomized 1:1 lymphodepletion vs no lymphodepletion arm. patients will be administered a single infusion of clbr001 cells followed by cycles of swi019 with regular assessments of safety and disease response to treatment. the goals are to establish the safety and efficacy of the combination therapy and determine if lymphodepletion is required for efficacy.

clbr001 + swi019 is novel switchable car-t cell combination therapy comprised of an autologous car (chimeric antigen receptor)-t product (clbr001, the switchable car-t cell \[scar-t\]) and swi019 (the "switch" biologic molecule). swi019 acts as an adapter molecule that controls the activity of the clbr001 car-t cell product.

Eligibility criteria:
inclusion criteria: * women or men age ≥18 of age at time of consent. * evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of this study. * adequate hematological, liver, pulmonary, and cardiac function * willing to participate to participate in long term follow up study. * confirmed diagnosis of moderate to severe systemic lupus erythematosus with lupus nephritis, systemic lupus erythematosus with extrarenal lupus, systemic sclerosis, and idiopathic inflammatory myositis. * failed at least two immunosuppressive treatments exclusion criteria: * inability to tolerate washout of prior therapy. * not willing/understanding the requirements of the clinical study * dependent on hemodialysis for a period of greater or equal to 3 months. * known hypersensitivity to prednisone or to both tocilizumab siltuximab. * have received plasmapheresis within 14 days prior to informed consent. * active bacterial, viral and/or fungal infection. * prior autologous/allogeneic stem cell transplant or solid organ transplant. * prior lentiviral or retroviral based therapy including car-t cell therapy. * history or concurrent malignancy with active treatment in the past 5 years * hiv-1 and hiv-2 antibody positive subjects. * history of central nervous system diseases (such as seizure, psychosis, organic brain syndrome or cerebrovascular accident).

Keywords: car-t systemic lupus erythematosus systemic sclerosis idiopathic inflammatory myopathy sle iim ssc cell therapy
prospective pain study comparing different treatments after hand surgery

Conditions: Post-operative Pain

Summary: the purpose of the study is to evaluate the efficacy of three different types of pain medication (oxycodone - an opioid, ibuprofen - a non-steroidal anti-inflammatory, and acetaminophen - a non-opioid analgesic) in the management of postoperative pain following single soft tissue procedures of the hand and wrist performed exclusively under local anesthesia without sedation. the results of this study will help define optimal prescribing guidelines following the two most common hand surgeries while also potentially validating the use of opioid alternatives post-operatively in order to help mitigate excessive or unnecessary dispensal of opioid analgesics.


Eligibility criteria:
inclusion criteria 1. patients indicated to undergo primary, unilateral carpal tunnel release or trigger finger release surgery under local anesthesia alone. 2. age eligibility is \> 18 years of age. 3. local anesthesia with 1% lidocaine with 1:100,000 epinephrine and bicarbonate. exclusion criteria 1. bilateral procedures. 2. additional soft tissue or boney procedures performed simultaneously. 3. the use of sedation and/or general anesthesia. 4. pediatric patients (age \< 18 years). 5. pregnant female patients. 6. non-english speaking patients. 7. known allergies or medical contraindications to oxycodone, ibuprofen, acetaminophen. 8. history of chronic pain and/or narcotic use preoperatively.
effects of gum arabic supplementation in hemodialysis patients

Conditions: Kidney Failure, Chronic

Summary: gum arabic is a naturally produced gummy exudate from acacia senegal tree. it's a complex polysaccharide with proven prebiotic properties. through its effect on intestinal bacteria, it's expected to reduce systemic levels of toxic bacterial metabolites and reduce inflammatory markers.by increasing fecal bacteria mass it's also expected to reduce blood urea level. these changes are potentially beneficial to hemodialysis patients who suffer from disturbed intestinal flora and a chronic inflammatory status. the investigators hypothesize that supplementing the diet of hemodialysis patients with gum arabic for four weeks would reduce inflammatory markers, increase total anti-oxidant capacity and reduce blood urea concentration.


Eligibility criteria:
inclusion criteria: * adult end-stage renal disease patients maintained on regular hemodialysis exclusion criteria: * chronic liver disease * malignant condition * inflammatory bowel disease * history of bowel resection * long term antibiotic therapy * pregnancy or lactation * current use of immunosuppressive medication
determination of intratumoral concentrations of kinase inhibitors in patients with advanced solid malignancies.

Conditions: Cancer; Advanced Solid Tumors

Summary: the purpose of this study is to determine intratumoral concentration of kinase inhibitors upon 2 weeks of treatment in tumor tissue of patients.

patients will be cohort-wise treated with clinically available kinase inhibitors for 2 weeks prior to standard palliative treatment. five patients will be included in each of eight drug cohorts. biopsies will be performed to determine intratumoral drug concentrations and to compare tissue (phospho)proteomic and kinase activity profiles before and during therapy.

Eligibility criteria:
inclusion criteria: * advanced solid malignancy * minimum age 18 years * indication for palliative treatment * measurable disease with at least one lesion accessable for biopsy exclusion criteria: * cardiovascular conditions including congestive heartfailure nyha class \>2 * recent myocardial infarction or uncontrolled coronary artery disease * cardiac arrhythmias requiring anti-arrhythmic therapy * uncontrolled hypertension * uncontrolled infections * serious non-healing wound, ulcer or bone fracture * pregnant or breast feeding
endoscopy for post-operative fistula

Conditions: Post-operative Fistula

Summary: endoscopic treatment of early post-operative fistula in patients with underlying esophageal or gastric cancer has now become the standard of care. however, data regarding the yield of this type of treatment is lacking. this study aims to evaluate endoscopic management of this post-operative complication. the main outcome of this prospective observational study conducted in tertiary centers in france is fistula healing defined as the absence of collection on ct scan (with opacification) in a patient on po diet, 3 months after the end of the endoscopic treatment.


Eligibility criteria:
inclusion criteria: * patient over 18 years * early fistula (\< 30 days) * post surgery: lewis santy, akiyama, partial or total gastrectomy * indication of endoscopic management: metal stents and/or plastic stents exclusion criteria: * pregnancy * incapable of decision making and informed consent * life expectancy \< 1 month * general anesthesia contra-indication * late fistula (\> 30 days) * prior endoscopic treatment * wall ischemia * duodenum or small bowel fistula * post bariatric surgery

Keywords: fistula upper digestive tract cancer
clinical trial to investigate the pharmacokinetics of second-line anti-tuberculosis agents

Conditions: Healthy

Summary: this study aims to investigate the pharmacokinetic characteristics of second-line anti-tuberculosis agents after oral/intramuscular administration in healthy male volunteers.


Eligibility criteria:
inclusion criteria: * healthy male subject aged 20 to 50 at screening * a body weight in the range of 55 kg (inclusive) to 90 kg (inclusive) with ideal body weight range of 19.0 to 26.0 subjects who decide to participate voluntarily and write a informed consent form exclusion criteria: * subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor * subject judged not eligible for study participation by investigator.

Keywords: antituberculosis agents pharmacokinetics
population based evaluation of the use of tnfα antagonists in pregnant women with inflammatory bowel diseases

Conditions: Inflammatory Bowel Diseases

Summary: : inflammatory bowel diseases (ibd), such as crohn's disease (cd) and ulcerative colitis (uc) need long term treatments which can conflict with a desire of pregnancy in women. uncontrolled ibd increases the risk of poor pregnancy outcomes \[1\]. antitumor necrosis factor α (antitnfα) are commonly used, off-label, in pregnancy but with the risk of treatment-related complications. existing recommendations on the use of antitnfα during pregnancy are conflicting and only rely on expert opinions. this study was aimed to assess appropriateness and risk to benefit ratio of antitnfα treatment during pregnancy in women with ibd, for both the mother and the baby until the end of the first year.


Eligibility criteria:
inclusion criteria: * pregnancy between 01/01/2011 and 31/12/2014 * diagnosis of ibd (crohn's disease or ulcerative colitis) exclusion criteria: * non ibd indication of antitnfα treatment
clinical performance of bioceramic vs high viscosity gic for cervical restorations of geriatric patients

Conditions: Cervical Caries

Summary: the aim of this study is to clinically evaluate the performance of the bioceramic glass ionomer compared to conventional high viscosity glass ionomer for restoration of carious cervical lesions in geriatric patients over 12 months follow up.


Eligibility criteria:
inclusion criteria: * geriatric patients aged above 55 years * patients with untreated carious lesions * patients who have at least 20 teeth under occlusion * patients with normal occlusion * vital teeth with carious cervical lesion with asymptomatic vital pulp. * teeth with no or minimum mobility. * teeth with normal occlusion. * teeth with surrounding healthy gingiva and supporting-structures. exclusion criteria: * patients who are unable to return for recall appointments * presence of abnormal oral, medical or mental conditions. * patients with severe medical diseases. * patients with xerostomia * patients with parafunctional habits. * non vital teeth. * teeth with signs or symptoms of pulpitis. * teeth with non carious lesions.
post marketing surveillance: newly diagnosed glioblastoma multiforme treated with radiotherapy/temozolomide and adjuvant temozolomide (study p04739)

Conditions: Glioblastoma

Summary: the purpose of this surveillance is to collect more safety and efficacy data in "non-study" patients during concomitant and adjuvant temozolomide therapy.


Eligibility criteria:
inclusion criteria: * patients must have newly diagnosed and operated glioblastoma multiforme with postoperative residual tumor \<=1.5 cm by magnetic resonance imaging (mri). * age \>=18 years. * hemoglobin \>=10 g/dl. * white blood cell count \>=1.5x10\^9/l. * platelet count \>=100x10\^9/l. * blood urea \<=1.5 x upper limit of normal values (uln). * creatinine \<=1.5 x uln. * bilirubin \<=1.5 x uln. * aspartate aminotransferase \<=3 x uln. * alanine aminotransferase \<=3 x uln. * alkaline phosphatase \<=2 x uln. exclusion criteria: * tumor-specific pretreatment. * contraindication against radiotherapy and/or chemotherapy. * malignomas other than basaliomas. * existing or planned pregnancy or lactation or inadequate contraception. * psychiatric disease. * simultaneous participation in another clinical trail or participation in another clinical trail in the last 30 days before recruitment.
feasibility of delphi screener for cervical cytology

Conditions: Cervical Neoplasia

Summary: the aim of this study is to see whether a new self-sampling device, the delphi screener (delphi devices, scherpenzeel, netherlands), can be used for cervical cancer screening. the results using the new device will be compared to results using the current gold standard. the gold standard is clinician-collected endo-cervical and ecto-cervical specimens (often referred to as a 'pap smear'). additionally, women will be asked about the acceptability of using the device and how easy it is to understand the user instructions. the delphi screener is a sterile, plastic, syringe-like device containing buffered saline which allows a woman to collect her own vaginal lavage (to 'self-squirt'). the hypothesis is that the device may work well for cervical cytology and will be acceptable to the women in the study.


Eligibility criteria:
inclusion criteria: * valid pap smear in last 1-3 months obtained at participating clinic * 18 years or older * self-report being able to read in english and/or spanish * willing to sign informed consent exclusion criteria: * used vaginal product (douche, spermicide, antifungal) in last 48 hours * last menses started ≤ 4 days prior to enrollment visit * no uterus / history of hysterectomy * self-report currently pregnant * self-report currently breastfeeding

Keywords: cervical cytology pap smear self-sampling abnormal normal
technological development and clinical parallel testing of pgt-g

Conditions: Genetic Disease

Summary: preimplantation genetic testing (pgt) has three different testings according to the type of genetic disease, which was classified as pgt-m, pgt-sr and pgt-a. if the couple is tested for two different genetic diseases at the same time, it is necessary to customize the probe and adopt different detection methods, which increases the cost and cycle of testing. advanced expert pre-experimental analysis is required for pgt-m in couples with monogenic disease. if the family members are unavailable, only the polar bodies, sperms or affected embryos can be used to analysis, which not only increases the risk of failure, but also increases the difficulty of detection. at present, bgi has developed a new single-tube complete long fragment whole genome sequencing (stlfr-wgs) technology, which uses the same molecular tag on the short read sequencing fragments from the same long dna molecule to achieve accurate short read sequencing to obtain long dna information. multiple genetic abnormalities such as gene variation, chromosome aneuploidy and chromosome structure rearrangement can be directly detected in embryos without pre-experiment of family members, so as to achieve universal normalization of the three pgt methods and solve the pgt detection needs of patients with multiple genetic diseases.


Eligibility criteria:
inclusion criteria: 1. patients undergoing pgt cycle; 2. patients with balanced chromosomal structural rearrangement (reciprocal translocation, robertsonian translocation, inversion, etc.) by conventional karyotype analysis; 3. clearly diagnosed monogenic genetic disease, and the related genes and their mutations are judged to be pathogenic or likely pathogenic; 4. chromosomal abnormalities in recurrent abortion tissues or in pgt-a embryos; the number of blastocysts was \>= 1, and the morphological classification was more than 4bc/4cb. exclusion criteria: 1. belonged to any contraindications of pgt; 2. failed to embryo biopsy; 3. failed to embryo wga failure or abnormal quality control; 4. failed to embryo sequencing, and the result was unknown.

Keywords: pgt stlfr-wgs
a study to evaluate efficacy and safety of an investigational drug named volixibat in patients with itching caused by primary sclerosing cholangitis (psc)

Conditions: Primary Sclerosing Cholangitis

Summary: the purpose of this clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment of pruritus (itching) associated with primary sclerosing cholangitis (psc), and to assess the possible impact on the disease progression of psc.


Eligibility criteria:
inclusion criteria: 1. provide freely signed informed consent and assent (as applicable) and be willing to comply with all study visits and requirements through end of study, including the follow-up period. 2. subjects aged ≥12 years for eligible regions; otherwise ≥18 years 3. confirmed diagnosis of large duct or small duct psc based on american association for the study of liver disease (aasld) guidelines. 4. pruritus associated with psc as assessed by adult itchro. 5. ursodeoxycholic acid (udca) and anti-pruritic medication use will be allowed if meeting additional criteria. 6. concomitant inflammatory bowel disease (ibd) is allowed if meeting additional criteria. exclusion criteria: 1. pruritus associated with an etiology other than psc 2. evidence or clinical suspicion of decompensated cirrhosis, or a history of decompensation events 3. history of ileostomy or small bowel surgery/resection or other surgeries that may have disrupted the enterohepatic circulation 4. evidence, history, or suspicion of other liver disease; psc patients with aih are not excluded. 5. bile duct stent or percutaneous bile duct drain placement, or balloon dilatation procedure of a stricture within 12 weeks of screening 6. exceeding pre-defined biochemical values for alanine aminotransferase/aspartate aminotransferase (alt/ast), estimated glomerular filtration rate (egfr),serum creatinine (scr), platelet count, international normalized ratio (inr) and total bilirubin 7. history of liver transplantation

Keywords: pruritus psc itch itching cholestasis
study of interleukin-21 for metastatic malignant melanoma and metastatic kidney cancer

Conditions: Melanoma; Kidney Neoplasms; Metastases

Summary: this study is being done to see if an experimental drug called recombinant interleukin-21 (ril-21) when given to patients with stage 4 malignant melanoma or stage 4 kidney cancer is safe and has any effect on these types of cancers.

this is a phase 1 safety study. everyone enrolled and eligible will be given ril-21. the study has 2 parts, part a will determine how high a dose of ril-21 can be safely given to patients with these types of cancers. part b will determine if the drug is of any benefit to patients with these types of cancers. part a may have up to 7 different dose groups. beginning with the lowest dose, 3 patients will be treated and will be watched for side effects. if the side effects are not severe, the next group of 3 patients will recieve a higher dose. this cycle is repeated until the highest tolerated dose group is found.

Eligibility criteria:
inclusion criteria: * 18 years and older with stage 4 metastatic malignant melanoma or stage 4 metastatic kidney cancer * ecog status of 0 or 1 * patients must have adequate liver, kidney and bone marrow function exclusion criteria: * known ocular melanoma * suspected or confirmed brain metastases * patient cannot have had a bone marrow transplant

Keywords: metastatic melanoma metastatic renal cell carcinoma
a study of xeloda (capecitabine) in patients with metastatic colorectal cancer

Conditions: Colorectal Cancer

Summary: this 2 arm study will assess the efficacy and safety of intermittent oral xeloda, or iv fluorouracil/leucovorin, in combination with intravenous eloxatin (oxaliplatin) in patients previously treated for metastatic colorectal cancer. patients will be randomized to receive either 1)xelox (xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin) in 3 week cycles or 2) folfox-4 (oxaliplatin + leucovorin + 5-fu in 2 week cycles. the anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.


Eligibility criteria:
inclusion criteria: * adult patients \>=18 years of age; * metastatic colorectal cancer; * \>=1 target lesion; * failed first-line chemotherapy with 5-fluorouracil and irinotecan. exclusion criteria: * previous treatment with oxaliplatin; * progressive or recurrent disease during or within 6 months of completion of first-line chemotherapy; * \>=1 previous chemotherapeutic agent or systemic anticancer regimen for metastatic disease.
the effect of color therapy on depression, stress, anxiety and quality of life in hemodialysis patients: a randomized controlled study

Conditions: Hemodialysis; Color Therapy

Summary: this study was conducted to examine the effect of color therapy on depression, stress, anxiety and quality of life in hemodialysis patients.

many patients on hemodialysis treatment require hemodialysis, which requires hospitalization three times a week for four hours each dialysis session. therefore, practices such as color therapy may be useful in the management of psychological symptoms in these patients.

Eligibility criteria:
inclusion criteria: * be on hemodialysis treatment for at least 6 months, * no sleeping pills or sedative medication, * no physical or cognitive impairment that prevents them from understanding the education and no diagnosis of a psychiatric illness, * the patient or someone living in the same household with the patient is literate, * patients have no vision problems, * patients must be 18 years of age or older. exclusion criteria: * being on hemodialysis treatment for less than 6 months, * taking sleeping pills or sedative medication, * being diagnosed with a physical illness or cognitive impairment or psychiatric illness that prevents understanding the education provided, * illiteracy of the patient and relatives, * patients have vision problems, * refusing to participate in the research, * under 18 years of age

Keywords: anxiety color therapy depression hemodialysis nursing quality of life stress