Kornimate/medical-research-clean huggingface dataset:
clinical trial to compare rebamipide/nizatidine combination therapy with nizatidine monotherapy in patients with gastritis

Conditions: Gastritis

Summary: the purpose of this study is to compare the efficacy and safety of rebamipide/nizatidine combination therapy with nizatidine monotherapy in patients with gastritis

the purpose of this study is to compare the efficacy and safety of rebamipide/nizatidine combination therapy with nizatidine monotherapy in patients with gastritis. anticipated result is to prove superiority of rebamipide/nizatidine combination therapy at 2 weeks compared to nizatidine monotherapy.

Eligibility criteria:
inclusion criteria: 1. male or female aged 19 years or older and under 75 years 2. subject who was diagnosed with acute or chronic gastritis in upper gastrointestinal endoscopy conducted within 7 days prior to the start of administration of medications for clinical trials and identified at least one labyrinth (defect of mucosal surface layer) 3. subject who voluntarily decides to participate in the trial after hearing the explanation of this clinical trial and signs the informed consent form. exclusion criteria 1. subject who is unable to examine the upper gastrointestinal endoscope 2. a person with the following past history * surgery to suppress gastric acid secretion or gastrointestinal and esophagus surgery * malignant tumor of the digestive system * overreacted to the components of medicine for clinical trials and h2 receptor blockers * drug or alcohol abuse 3. a person accompanied by the following diseases * digestive ulcers (excluding half a scar) * reflux esophagitis * inflammatory bowel disease (cron disease, ulcerative colitis) * thrombotic diseases (such as cerebral thrombosis, myocardial infarction, thrombotic venous inflammation, etc.) * zollinger-ellison syndrome * subject with mental illness, cardiovascular system, respiratory system, endocrine system, central nervous system who the investigator determined that it is difficult to participate in this clinical trial 4. a person who needs to administer a taboo drug during the clinical trial period. 5. pregnant women and nursing women 6. fertilized women and men who have a pregnancy plan or do not have the will to use the appropriate contraceptive method during the clinical trial period. 7. subject with genetic problems such as galactose intolerance, lapp lactase deficiency, glucose-galactose malabsorption, etc. 8. severe liver disorder (ast or alt \> 3 times the normal upper limit of the organ) 9. serious nephropathy (creatinine clearance \< 50 ml/min) 10. subject who has been administered (applied) other clinical medications or medical devices within 4 weeks of screening 11. subject who the investigator determined it is inappropriate to participate in this clinical trial.
web-based methodology trial to evaluate the efficacy and safety of tolterodine er in subjects with overactive bladder

Conditions: Overactive Bladder

Summary: to compare the effect of tolterodine er 4 mg to placebo on patient reported outcomes in subjects with overactive bladder after 1, 4, and 12 weeks of treatment using an innovative web-based trial design


Eligibility criteria:
inclusion criteria: * female and 21 years or older * overactive bladder symptoms (subject-reported) for at least 3 months * be resident in the united states of america and have access and be able to use a computer with internet access throughout the duration of the study exclusion criteria: * clinically significant hepatic, renal or neurological condition such as stroke (with residual deficit), multiple sclerosis, spinal cord injury, or parkinson's disease. * history of cystitis, continence, urogenitalcancer or radiation * subjects who are pregnant, nursing, or with a positive urine pregnancy test or who are intending to become pregnant within 28 days after the completion of the trial.

Keywords: double-blind placebo-controlled frequency urgency web-based incontinence methodology ediary safety efficacy tolerability er overactive bladder
multi-car-t cells targeting b cell lymphomas

Conditions: B Cell Lymphoma (BCL)

Summary: this study aims to evaluate safety and efficacy of a combination of 4th generation chimeric antigen receptor gene-modified t cells targeting b cell surface molecules including cd19 and alternative carts as booster and consolidation treatment for patients with highly resistant b cell lymphomas, including primary mediastinal b cell lymphoma (pmbcl) and bcl involving central nervous system (cns-bcl). clinical response and development of a simplified and standardized lentiviral vector and cell production protocol will be investigated. this is a phase i/ii trial enrolling patients from multiple clinical centers.

chimeric antigen receptor (car) t cell therapy has proven effective in treating b cell malignancies. however, post cd19-cart relapses occur at high rate due to the cd19 antigen loss or the exhaustion of cart cells. furthermore, the success of treating relapsed/refractory b cell lymphoma (bcl) such as primary mediastinal b-cell lymphoma (pmbcl) and cns-involved bcl has been limited. to overcome tumor escape and prolong in vivo cart efficacy, we have developed a novel multiple car-t therapy regimen including booster and consolidation cart applications to to target highly-refractory cancer. selected patients will be enrolled after target antigen confirmation including cd19, cd20, cd22, cd70, cd13, cd79b, gd2 and psma through immunostaining of their tumor specimens. the aim is to evaluate safety and long term efficacy of the multiple cart therapy strategy in the bcl patients.

Eligibility criteria:
inclusion criteria: 1. age older than 6 months. 2. primary b cell lymphoma surface expression of cd19 and/or cd22/cd70/psma/ cd13/cd79b/gd2 molecules. 3. the kps score over 80 points, and survival time is more than 1 month. 4. greater than hgb 80 g/l. 5. no contraindications to blood cell collection. exclusion criteria: 1. accompanied with other active diseases, and difficult to assess response after treatment. 2. bacterial, fungal, or viral infection, unable to control. 3. living with hiv. 4. active hbv and hcv infection. 5. pregnant and nursing mothers.6. under systemic steroid treatment within a week of the treatment. 7. prior failed car-t treatment.

Keywords: car-t cd19 cd20 cd22 cd70 psma cd13 cd79b gd2 pmbcl cns-bcl
interest of the nefopam and pca morphine combination for postoperative analgesia in patients undergoing colon surgery

Conditions: Colonic Neoplasms; Diverticulosis, Colonic

Summary: this study analyses interest of iv nefopam in combination with paracetamol after major abdominal surgery because the effect of morphine-sparing is discussed when combined these agents.


Eligibility criteria:
inclusion criteria: * adult patient with a score asa between i and iii * patient scheduled for elective major abdominal surgery (by laparotomy) for cancer or diverticulosis * patient that signed the consent form exclusion criteria: * - patient treated in emergency situation * patient with chronic inflammatory bowel disease (crohn's disease, ulcerative colitis) * patient that needs a surgery for restoration of continuity * patient pregnant, breastfeeding, or during periods of genital activity using no contraception. * patient with contraindications to nefopam, morphine, or paracetamol * patient with chronic obstructive pulmonary disease, renal or severe hepatic impairment * patient under analgesics treatment * patient who participated in a clinical study in the previous 6 months.
"computer-guided vs freehand zygomatic implant placement

Conditions: Dental Implants; Maxillary Diseases

Summary: this randomized trial compares computer-guided versus free-hand zygomatic implant placement in patients with atrophic maxillae or maxillary defects. participants receive either 3d-navigated implants (using stereolithographic guides) or conventional free-hand placement. primary outcomes measure accuracy through apical angular deviation (°), apical/coronal linear deviations (mm) relative to msp/fhp/cp planes (ct-based), while secondary outcomes assess implant stability (isq) and complications (sinusitis/infection) over 6 months. the study evaluates whether guided surgery improves precision in complex maxillary rehabilitation.

"this study was retrospectively registered due to initial lack of awareness of prospective registration requirements. all procedures followed ethical guidelines (approval #880/62), and results are reported transparently." study design a single-center, randomized controlled trial conducted at al-azhar university, comparing computer-guided versus free-hand zygomatic implant placement. participants are allocated 1:1 to: group a (free-hand): implants placed using zaga classification with conventional surgical techniques. group b (guided): implants placed via 3d-printed bone-supported surgical templates (dicom-based planning). interventions both groups: pre-op: ct scans for zygomatic bone assessment. anesthesia: general anesthesia with local infiltration for hemostasis. surgical protocol: full-thickness flap, implant placement , two-stage healing. group b-specific steps: digital implant path planning (entrance/exit points). stereolithographic guide fabrication with metal sleeves. guide fixation with monocortical screws during surgery. rationale zygomatic implants require high precision due to anatomical complexity. while free-hand placement depends on surgeon skill, computer guidance may reduce errors. this trial evaluates whether guided surgery improves accuracy (angular deviation) and reduces complications (sinusitis, infection). methodological rigor randomization: block randomization via spss. blinding: radiographic assessors blinded to group allocation. sample size: 16 implants (8/group), powered to detect 3.73° mean angular deviation difference (α=0.05, β=0.10; based on grecchi et al. 2022). ethical compliance approved by al-azhar university (ref: 880/62). consent forms documented risks/benefits (e.g., sinus perforation, infection).

Eligibility criteria:
inclusion criteria: * patients aged ≥40 years * atrophic maxillary ridge (cawood \& howell class iv-vi) * maxillary defects due to trauma, tumor resection, or congenital conditions exclusion criteria: * acute maxillary sinusitis * uncontrolled systemic diseases affecting osseointegration * pathological lesions in maxilla/zygoma * heavy smoking (\>20 cigarettes/day)

Keywords: "zygomatic implants" "atrophic maxilla rehabilitation" "guided implant surgery" "free-hand dental implantation" "3d-printed surgical guides"
recurrence rate, risk factors for the recurrence, and quality of life in patients with gerd in korea-an observational

Conditions: The Aim of This Study is to Investigate the Frequency and Related Risk Factors of Recurrence, and Quality of Life in Patients With GERD After Treatment With PPI

Summary: recurrence rate, risk factors for the recurrence, and quality of life in patients with gerd in korea-an observational study.


Eligibility criteria:
inclusion criteria: * both erd or nerd patient who confirmed by egd findings within 12 months prior to v1 and have a symptom with moderate or more, at least once per week within 1 week prior to v1 and patients between age 20 and 80with typical reflux symptoms * among the patient who have not taken ppi or h2 blocker within 4 weeks prior to v1, needs to be prescribed ppis 4\~8 weeks as a part of the routine clinical practice due to typical symptom * patients who give the signed informed consent exclusion criteria: * patients with past history of gastrointestinal surgery * patients with known malignancy or history of such diseases * patients with moderate to severe general medical conditions like ischemic heart disease, chronic renal failure, congestive heart failure, copd, liver cirrhosis, acute or chronic pancreatitis, or other medical conditions which the investigator considers

Keywords: gerd comparison between erd and nerd rate of complete resolution rate of recurrence qol to investigate the frequency and related risk factors of recurrence, and quality of life in patients with gerd after treatment with ppi the aim of this study is to investigate the frequency and related risk factors of recurrence, and quality of life in patients with gerd after treatment with ppi
non interventional clinical investigation of ectoin ear spray in skin treatment of outer ear canal irritations

Conditions: Pruritus; Dermatitis; Otitis Externa

Summary: in this observational study, insights regarding the tolerability and influence on the quality of life of the topical treatment with ectoin ear spray compared to normison ear spray shall be gained under real life conditions in patients with chronic eczematous irritations and pruritus of the outer ear canal.


Eligibility criteria:
inclusion criteria: * according to instructions for use exclusion criteria: * otitis media, acute otitis media * acute otitis externa * earache * perforation of the ear-drum (membrana tympani) * infections at the ear * systemic corticosteroid treatment or local at the ear

Keywords: dermatitis and irritations at the outer ear canal prevention of subacute otitis externa
hepatitis b in cystic fibrosis and latent tuberculosis respectively

Conditions: Cystic Fibrosis; Hepatitis A; Hepatitis B; Tuberculosis

Summary: cf patients are at risk for hepatic disease. vaccination is recommended to all cf patients according to european consensus. the aim of the study is to vaccinate as many patients as possible and to follow up whether immunization has been complete.

initially, healthy volunteers will be vaccinated to be compared with patients' antibody response to hepatitis a and b vaccine. the connected part of this study is to vaccinate children suffering from latent tuberculosis against hepatitis b and to measure whether the immunization is related to specific interferon gamma response against mycobacterium tuberculosis.

Eligibility criteria:
inclusion criteria: * cf patients not previously immunized against hepatitis a or b * healthy volunteers not previously immunized against hepatitis a or b * age over 1 year exclusion criteria: * previously transplanted patients * previous vaccination with hepatitis vaccine * known allergy against components in twinrix (tm)
enhancing the efficacy and tolerability of metformin by add-on polyherbal formulation: a gut microbiome study

Conditions: Diabetes Mellitus Type 2

Summary: study population: type 2 diabetes patients design of the study: randomized, two-arm, placebo-controlled, and prospective crossover cohort study. objective: to evaluate the effects of interactions between metformin and traditionally used polyherbal formulations on gut microbiota in a prospective crossover study involving type 2 diabetes mellitus patients. sample size: 66 patients. duration of study: 06/2024 - 12/2026


Eligibility criteria:
inclusion criteria: participants must meet all of the following criteria to be eligible for enrollment: clinical diagnosis of type 2 diabetes mellitus (t2d) hba1c level between 6.5% and 8.5% on a stable dose of oral antidiabetic therapy for at least 6 months age: ≥ 25 years and ≤ 80 years history of metformin intolerance, defined as previously reported gastrointestinal side effects or inability to tolerate full-dose metformin willing and able to provide written informed consent willing to comply with study procedures, including stool sample collection and continuous glucose monitoring (cgm) exclusion criteria: participants will be excluded if they meet any of the following criteria: type 1 diabetes mellitus current or recent (last 6 months) use of polyherbal formulations (phf) pregnancy or breastfeeding severe diabetic complications, such as: diabetic ketoacidosis proliferative retinopathy chronic kidney disease stage iiib or higher (egfr \<45 ml/min/1.73m²) recent cardiovascular events (within the last 6 months), including: stroke myocardial infarction unstable angina heart failure severe systemic disease that could interfere with participation, such as: active cancer severe autoimmune disease current antibiotic therapy (within 2 months of study enrollment) use of probiotics or prebiotics (within 1 month of study enrollment) severe gastrointestinal conditions, including: inflammatory bowel disease chronic diarrhea of unknown origin severe infection requiring antibacterial therapy participation in another interventional study within the last 3 months

Keywords: microbiome metformin diabetes polyherbal formulation
psychological, psychophysical and epigenetic determinants of chronic pain after cytoreductive - hyperthermic intraoperative chemotherapy

Conditions: Appendix Carcinoma; Carcinomatosis; Colorectal Carcinoma; Gastric Carcinoma; Malignant Peritoneal Neoplasm; Malignant Solid Neoplasm

Summary: this study learns if depression, anxiety, and catastrophizing (thought patterns that prompt people to expect the worst) are associated with chronic pain after surgery among patients who are scheduled to have cytoreductive surgery with intraoperative hyperthermic chemotherapy. information from this study may improve the understanding of persistent and chronic postsurgical pain integrating multiple layers of biological and behavioral sciences.

primary objective: i. to evaluate the association of preoperative psychological risk factors (depression, anxiety or catastrophizing) with the development of chronic postsurgical pain after cytoreductive surgery with intraoperative hyperthermic chemotherapy (crs-hipec). secondary objectives: i. to evaluate the association of preoperative psychological risk factors (depression, anxiety or catastrophizing) with the development of persistent postsurgical pain after crs-hipec. ii. to evaluate the association between preoperative abnormal sensory disturbances and chronic postsurgical pain after crs-hipec. iii. to assess the association of blood micro ribonucleic acids (rnas) signatures with the development of chronic postsurgical pain after crs-hipec. iv. to determine the rate of and factors associated with persistent and chronic opioid use after crs-hipec. v. to determine the rate of persistent and chronic postsurgical anxiety and depression. vi. to investigate changes in psychological risk factors (depression, anxiety or catastrophizing) and sensory disturbances after crs-hipec overtime. exploratory objective: i. to explore the impact of perioperative (in-patient) opioid use, non-opioid analgesic use and anesthetics on the development of persistent and chronic opioid use after crs-hipec. outline: patients complete questionnaires over 15 minutes and undergo pain assessments prior to surgery and at 3, 6 and 12 months after surgery. patients also undergo blood sample collection before surgery and optionally at 3, 6 and 12 months after surgery.

Eligibility criteria:
inclusion criteria: * 18 years of age or older; with or without history of preoperative abdominal pain * american society of anesthesiologists physical status (asa) 1-4 * scheduled surgery: open crs-hipec surgery for primary peritoneal malignancy or secondary carcinomatosis (i.e., appendiceal, colorectal and gastric cancers) * written informed consent exclusion criteria: * asa \>= 4 or emergency surgeries * patients with extra-abdominal metastatic disease * patients cognitive or neurologically unable to complete questionnaires preoperatively * non-english-speaking patients * pregnant women
biatain silicone sacral for pressure injury prevention in hospital-admitted patients at risk

Conditions: Pressure Injury Prevention

Summary: a post market clinical follow-up study investigating the safety of biatain silicone sacral while used as prevention in hospital admitted patients at risk of developing a pressure injury.

the investigation was a multi-centre, open label, non-comparative, single-arm, prospective study, conducted at three investigational sites in danish hospitals. 67 hospital-admitted patients were enrolled in the study over a 3-month recruitment period. the target population were patients ≥18 years of age with an expected hospital-stay of more than 24 hours from baseline and a braden score of 6-18. at daily visits skin inspections for signs of non-blanchable erythema or sacral pressure injury were performed by partial lift and reapplication of the dressing. after 7 days, or earlier if the patient was discharged, a termination visit was performed. skin assessment was performed upon removal of the dressing and a termination form completed. information regarding adverse events and device deficiencies were collected at all visits. there were no follow-up visits after termination of the study.

Eligibility criteria:
inclusion criteria: * hospital-admitted patients at risk of developing a pressure injury with an expected hospital-stay of more than 24 hours from visit 1 * ≥18 years of age and has full legal capacity * has given written consent to participate by signing the informed consent signature form * has a braden score of 6-18 at screening (performed within the last 24 hours) * intact sacral skin (non-breached skin, without signs of non-blanchable erythema over bony prominence/pre-existing sacral pressure injury over bony prominence) exclusion criteria: * suspected or actual spinal injury precluding the patient from being turned * sacral erythema, sacral pressure marks, pre-existing sacral pressure injury * trauma to sacrum * topical treatment with steroid creme in the sacral area (treatment must have been terminated at least 14 days prior to enrollment) * pregnancy or breastfeeding
a study is to assess efficacy and safety of tacrolimus in active rheumatoid arthritis patients who showed unsuccessful response to existing disease modifying antirheumatic drugs (dmards)

Conditions: Rheumatoid Arthritis

Summary: this study is to assess efficacy and safety of tacrolimus in active rheumatoid arthritis patients who showed unsuccessful response to existing dmards.


Eligibility criteria:
inclusion criteria: * subjects who have rheumatoid arthritis for 6 months or longer based on american college of rheumatology (acr) diagnostic criteria * subjects who used more than 1 disease modifying antirheumatic drug (dmard) including mtx (methotrexate) for 6 months or longer * subjects with esr (erythrocyte sedimentation rate) ≥ 28mm/h or crp (c-reactive protein)≥ 1.0 mg/dl * subjects with ≥ 3 swollen joints out of 66 joints assessed * subjects with ≥ 6 tender joints out of 68 joints assessed exclusion criteria: * pregnant or nursing women, or subjects who plan to become pregnant within 6 months or whose screening test results show pregnancy cannot be ruled out * subjects with previous experience of tacrolimus (excluding external preparations) * subjects with renal dysfunction or with serum creatinin \> 1.4 mg/dl at screening * following subjects with hepatic dysfunction: viral infection, non-viral infection, hepatic cirrhosis, and serum glutamic oxaloacetic transaminase / serum glutamic pyruvic transaminase (sgot/sgpt) exceeding twice the upper limit of normal at screening * subjects with pancreatitis, uncontrolled diabetes or complication(s) or with hba1c \> 6.4% at screening * subjects complicated with hyperkalemia or with serum potassium level \>5.5 meq/l at screening * subjects with history of heart disease (ischemic heart disease, arrhythmia requiring treatment, and heart failure), etc or complications * subjects complicated with severe respiratory disease and infection * subjects with history of malignant tumor or complication(s) (however, the subjects who are considered to have no risk of recurrence with malignant tumor untreated for 5 years or longer can enter the study. the subjects who succeeded in treatment for basal cell or squamous cell carcinoma of skin can also enter the study.) * subjects who were treated with other investigational product(s) within 3 months before screening * other subjects who are considered ineligible for the study by the investigator

Keywords: calcineurin inhibitor prograf rheumatoid arthritis (ra) tacrolimus