Kornimate/medical-research-clean huggingface dataset:
predictors of treatment response to aflibercept and aqueous cytokine levels in diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: diabetic macular edema refers to swelling (fluid accumulation) in the center of the retina. the retina is like the film of a camera and is located in the back of the eye. this condition can develop in diabetics where swelling results from leaking of fluid from the blood vessels of the eye, into the center of the retina, the macula. if left untreated, this can affect central vision. the current standard treatment for diabetic macular edema includes medications injected directly into the eye (intravitreal injections) and laser eye treatment. the drugs that are injected directly into the eye are known as anti-vascular endothelial growth factor (anti-vegf) agents which help to reduce the leaking. however, response in patients to these anti-vegf drugs can vary and examination of predictive factors is required. this particular study examines cellular factors called cytokines in patients receiving aflibercept, a type of anti-vegf drug, in the hopes of detecting changes in cytokines that can predict treatment response amongst groups of patients.


Eligibility criteria:
inclusion criteria: * male or female aged 18 years or above * presence of non proliferative diabetic retinopathy (npdr) * treatment naïve patients with dme with central macular thickness of 310μm or more on sd-oct (cirrus) * subjects with type i or ii diabetes mellitis * willing and able to provide informed consent for participation in the study exclusion criteria: * proliferative diabetic retinopathy in the study eye or prp within the last 12 months or anticipated prp in the next 6 months * uncontrolled glaucoma * history of intraocular surgery within 3 months in the study eye * history of vitrectomy surgery * laser treatment within 3 months of study eye * vitreomacular traction, epiretinal membrane or any other maculopathy in the study eye * prior intravitreal injection within the past 6 months * known allergy to the study drug or fluorescein * history of stroke or ami within 6 months of enrollment * patients receiving dialysis for renal failure * patients currently on systemic immunosuppression * patients on two or more class of medication for glaucoma in study eye * patients with tuberculosis * patients who are pregnant. * unwilling or unable to follow or comply with all study related procedures

Keywords: diabetic macular edema ocular cytokines triamcinolone acetonide
a study to evaluate the safety, tolerability, and pharmacokinetics of inhaled montelukast (mk-0476) in participants with mild or moderate asthma (mk-0476-380 am3)(completed)

Conditions: Asthma

Summary: a study to evaluate the safety, tolerability and pharmacokinetics of inhaled montelukast (mk-0476) in participants with mild or moderate asthma.


Eligibility criteria:
inclusion criteria: * male or female between the ages of 18 and 65 * must have mild or moderate asthma (part iii only) * nonsmoker for at least 6 months exclusion criteria: * history of stroke, chronic seizures or major neurological disorder * you are nursing * drink more than 3 glasses of alcohol a day * have allergy to or not able to tolerate lactose * have a history of drug abuse in the last 5 years * drink more than 6 beverages containing caffeine a day * have had surgery, donated blood or participated in another investigational study in the last 4 weeks
daikenchuto for intestinal dysmotility and prevention of postoperative paralytic ielus after pancreaticoduodenectomy

Conditions: Paralytic Ileus

Summary: a multicenter randomized-controlled trial of daikenchuto (tj-100), a traditional japanese herbal medicine (kampo), to investigate its effect on intestinal dysmotility and for the prevention of postoperative paralytic ileus.

daikenchuto (tj-100), a traditional japanese herbal medicine, is used for prevention and treatment of postoperative ileus. tj-100 extract powder (tsumura \& co., tokyo, japan) is manufactured as an aqueous extract containing 2.2 % japanese pepper, 5.6 % processed ginger, 3.3 % ginseng, and 88.9 % maltose syrup powder. a recent randomized, parallel-group, double-blind, placebo-controlled, dose-response trial demonstrated that tj-100 accelerates colonic transit time, particularly in the ascending colon. given its potential actions in the intestinal tract, it seems reasonable to postulate that tj-100 may play a role in improving and preventing bowel dysmotility. this study was designed to investigate the effect of tj-100 on intestinal dysmotility and for the prevention of postoperative paralytic ileus in patients undergoing pancreaticoduodenectomy. the primary endpoint is the incidence of postoperative paralytic ileus. secondary endpoints are qol assessment by the gastrointestinal symptom rating scale (gsrs) score (japanese version) and visual analogue scale, the change in ratio of abdominal circumference, the incidence of postoperative complications, the length of hospital day, and the incidence of surgical site infection. two hundred patients are required for the study (100 patients per group).

Eligibility criteria:
inclusion criteria: * patients with periampullary tumors (extrahepatic bile duct tumor, tumors of ampulla of vater and duodenal tumor) and pancreatic tumors (pancreatic cancer, intraductal papillary mucinous neoplasm of the pancreas, pancreatic endocrine tumor and pancreatic neuroendocrine tumor) of the head of the pancreas who are scheduled to undergo pd. * age of at least 20 years old at the time of registration. * all patients provided written informed consent before initiation of study-related procedures. exclusion criteria: * clinically problematic cardiac disease. * liver cirrhosis or active hepatitis. * severe pulmonary disease (interstitial pneumonia, pulmonary fibrosis, pulmonary emphysema etc.). * chronic renal failure requiring hemodialysis. * other malignant disease that can influence the adverse effect. * patients with tumors requiring resection of colon. * patients who are expected to have severe intra-abdominal adhesion due to past surgical history or past peritonitis history. * patients who had used gastrointestinal prokinetic medication, antipsychotic medication or antidepressants. * patients who had used japanese herbal (kampo) medicines within 4 weeks before registration. * pregnant or lactating women. * any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.

Keywords: daikenchuto postoperative ileus pancreaticoduodenectomy
tissue-resident immune cell subsets in agvhd

Conditions: Acute Graft-versus-Host Disease; Hematopoietic Stem Cell Transplantation

Summary: this is a prospective study investigating the role of tissue-resident immune cell subsets in the occurrence and progression of graft-versus-host disease following hematopoietic stem cell transplantation. approximately 40 subjects(including 20 grade 3-4 agvhd patients and 20 grade 1-2 agvhd patients ).

this study was a single-center, observational, prospective cohort study. the study lasted for 3 months, from 2024.11 to 2025.02.it is planned to enroll 40 subjects, divided into 20 grade 3-4 agvhd patients and 20 grade 1-2 agvhd patients. no randomization or any protocol-driven treatment will be performed or provided to subjects during the course of the study. treatment decisions and selection of treatment options are left to the discretion of the treating physician, if clinically appropriate. all recipients will be followed for agvhd evaluation,overall survival(os) ,disease-free survival (dfs). agvhd were graded according to published guidelines. all recipients will be monitored every month until the study is completed.

Eligibility criteria:
inclusion criteria: 1. voluntarily sign the informed consent form; 2. age 16-65 years old 3. clinically diagnosed with gvhd for the first time/receiving gvhd treatment. exclusion criteria: 1. have a history of other tumors 2. with poor compliance or mental disorders 3. infected with hiv and hcv 4. with uncontrolled hbv infection 5. with other autoimmune diseases 6. those who are judged by the researcher to be unsuitable to participate in this study
efficacy and safety evaluation of alirocumab (sar236553/regn727) in patients with primary hypercholesterolemia on stable atorvastatin therapy in japan

Conditions: Hypercholesterolemia

Summary: alirocumab (sar236553/regn727) is a fully human monoclonal antibody that binds proprotein convertase subtilisin/kexin type 9 (pcsk9). primary objective of the study: to evaluate the effect of alirocumab on low-density lipoprotein cholesterol (ldl-c) levels after 12 weeks of treatment in comparison with placebo in participants with ldl-c ≥100 mg/dl (≥2.59 mmol/l) on ongoing stable atorvastatin therapy. secondary objectives: * to evaluate the effects of alirocumab on other lipid levels after 12 weeks of treatment in comparison with placebo * to evaluate the safety and tolerability of alirocumab * to evaluate the development of anti-alirocumab antibodies * to evaluate the pharmacokinetics of alirocumab

the duration of study participation depended on the status of the participant at screening: 21 to 27 weeks including a screening/run-in period of 1 to 7 weeks, a double-blind treatment period of 12 weeks, followed by an 8-week follow-up period.

Eligibility criteria:
inclusion criteria : - participants with primary hypercholesterolemia treated with atorvastatin at stable dose of 5-20 mg for at least 6 weeks prior to screening and likely to have ldl-c ≥100 mg/dl (≥2.59 mmol/l) at the screening visit. or - participants with primary hypercholesterolemia who were receiving a lipid-lowering treatment other than atorvastatin, or who were not at stable dose of atorvastatin 5-20 mg for at least 6 weeks prior to screening if they were likely to have ldl-c ≥100 mg/dl (≥2.59 mmol/l) after a 6-week run-in treatment period on atorvastatin therapy. exclusion criteria: 1. ldl-c \<100 mg/dl (\<2.59 mmol/l) * at screening visit for participants who were being treated with stable dose of atorvastatin 5-20 mg for at least 6 weeks prior to screening or * at the end of the 6-week run-in period on atorvastatin for participants receiving a lipid lowering treatment other than atorvastatin, or not at stable dose of atorvastatin 5-20 mg for at least 6 weeks prior to screening 2. participants with type 1 diabetes 3. participants with type 2 diabetes treated with insulin, or without, and considered poorly controlled at screening. the above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
dosimeter location in pain physicians

Conditions: RAD

Summary: the primary objective is to determine if there is a significant difference in radiation readings between dosimeters worn on the chest versus the hand of interventional pain management physicians and elucidate which dosimeter had higher readings. the secondary objective is to track incidences of physician glove breaches in both groups to assess if wearing hand dosimeters is associated with an increased risk of this event.


Eligibility criteria:
inclusion criteria: * physicians actively performing fluoroscopy procedures at the comprehensive pain center. exclusion criteria: * those that do not want to participate in the quality improvement project.

Keywords: dosimeter radiation pain medicine physician
quantitative evaluation of motor function before and after surgery for degenerative lumbar spinal stenosis

Conditions: Lumbar Spinal Stenosis

Summary: low back pain is a leading cause of medical consultations in france and in other industrialized countries. although spinal surgery is a recognized treatment, to date, its impact has only been assessed using subjective or declarative criteria. yet, in many orthopaedic diseases, it has been shown that the evaluation of functional capacities, including walking speed, is particularly useful to study the impact of these diseases and their treatment. to date, no study has attempted to assess the impact of spinal surgery by evaluating 1) the functional capacities of patients and 2) spatio-temporal parameters of locomotion and joint dynamics. the investigators hypothesize that spinal surgery in patients with symptomatic lumbar spinal stenosis should lead to an improvement in quantifiable locomotion parameters, and in particular walking speed. walking speed is a quantitative measurement, which could reflect the degree of functional impairment of the patient before and after surgery.


Eligibility criteria:
inclusion criteria: patient: * more than 18 years old * who has provided verbal consent * with acquired arthritic lumbar spinal stenosis * eligible for surgery (pain \> 3 months, resistant to medical treatment) * for whom the neurosurgeon has scheduled nerve decompression without osteosynthesis or instrumentation * able to walk ≥ 10 metres without help exclusion criteria: patient: * adult under guardianship * absence of health insurance cover * pregnant or breast-feeding women * history of lumbar spinal surgery involving posterior or anterior arthrodesis * history of lumbar spinal surgery involving arthroplasty * history of lumbar spinal surgery within the previous 12 months * locomotor disorders due to causes other than spine disease (orthopaedic, neurological, vascular, cardiac...) that could significantly affect walking speed * patients in whom the surgery could not be done or deferred (intolerance to the ventral decubitus position, infection...) * patients who had revisit surgery before m6 (with the exception of early revisit surgery during the first month post-intervention) * patients in whom osteosynthesis or the implantation of instruments was decided and done during the surgery
communicating about choices in transplantation

Conditions: End Stage Renal Disease and Kidney Transplantation

Summary: the purpose of this study is to test the impact of a newly developed educational program on kidney transplant candidates' communication about living and deceased donor kidney transplantation.

the communicating about choices (coach) in transplantation program educates patients with end stage renal disease, who are waitlisted for kidney transplantation, about kidney disease and the risks, benefits and processes for both living and deceased donor transplantation. the program also teaches key communication skills needed to effectively initiate and manage conversations about transplantation.

Eligibility criteria:
inclusion criteria: * wait listed for kidney transplantation in active status * adult (at least 18 years of age) * english speaking * capable of making medical decisions (i.e., not cognitively impaired) * non-institutionalized exclusion criteria: * not listed for kidney transplantation

Keywords: end stage renal disease kidney transplantation transplant options (living and deceased donor) patient education communication skills training
a clinical study of omalizumab in the treatment of allergic asthma(essence)

Conditions: Moderate to Severe Allergic Asthma

Summary: allergic asthma being the most widespread and easily identifiable phenotype, accounting for 60-80% of cases.previous studies have reported that nearly 90% of patients with severe asthma were cases of allergic asthma, in which immunoglobulin e (ige) plays a critical role.omalizumab was approved as an anti-ige humanized monoclonal antibody for the treatment of patients with poorly controlled moderate-to-severe asthma, and was the first targeted drug used in the field of asthma treatment.the drug was launched in mainland china in august 2017.whereas,the clinical application experience, effects, and relevant data in the domestic population still lacking.the aim of this study was to observe the efficacy and safety of omalizumab, and to investigate whether baseline clinical characteristics and biomarkers can predicted response and adherence to treatment.


Eligibility criteria:
inclusion criteria: * moderate-to-severe asthma patients aged ≥ 14 years who met the criteria of the asthma group of the chinese thoracic society (guidelines for bronchial asthma prevention and management, 2020 edition)-moderate asthma was defined as those who could achieve complete control using grade 3 therapy, and severe asthma was defined as fully or incompletely controlled with grade 4 or 5 asthma medications. * history of asthma exacerbations induced by allergen exposure , elevated total serum ige and positive specific ige test or positive skin prick test. * treatment with omalizumab. exclusion criteria: * hypersensitivity to the active ingredient of omalizumab. * asthma exacerbation in the baseline. * combined with diseases that severely affect ventilation,such as bronchiectasis, lung cancer, allergic bronchopulmonary aspergillosis (abpa), acute respiratory infections, chronic obstructive pulmonary disease (copd),etc. * receiving other biologically targeted therapies (e.g., anti-interleukin (il)-5 monoclonal antibody, anti-il-4 monoclonal antibody, anti-il-13 monoclonal antibody, anti-il-5 receptor α (il-5rα) monoclonal antibody, etc.)

Keywords: asthma omalizumab allergy ige
evaluation of anxiety in surgery preoperative area (asdt)

Conditions: Preoperative Area

Summary: anxiety is associated with discomfort but also with an increased risk of pain and/or analgesic consumption. a prescription of anxiolytics is very common in pre-anesthetic consultation but without considering the real anxiety level of the patients. the objective of this premedication is mainly to improve patient comfort, to reduce patient anxiety and to improve patient cooperation. according to a study conducted in the 1990s, 40 to 80% of patients are anxious before surgery. consequences of anxiety are somatic (tachycardia, hypertension, difficulty to falling asleep), behavioural (aggressiveness, regression, fight against anaesthesia induction) and postoperative pain. preoperative area is a place of convergence for patients who need surgery or an interventional procedure. staying in the preoperative area may be a source of anxiety and may affect the patient management. the investigators will interview patients undergoing surgery or interventional procedure to assess their level of anxiety, pain and their experiences during their stay in preoperative area. the objective is to analyse the level of anxiety and / or pain and their clinical consequences, and then to assess the relationship with any potential premedication.


Eligibility criteria:
inclusion criteria: * patient in preoperative area before surgery or interventional procedure * patient to receive general anesthesia, local, locoregional, sedation, * agreeing to participate in the study after receiving information note, * ≥ 18 years of age. exclusion criteria: * \< 18 years

Keywords: anxiety pain preoperative area premedication
the impact of running therapy on mental health of youth in a psychiatric adolescent department

Conditions: Psychiatric Disorder; Mental Health Issue

Summary: a randomized controlled trial, whereby the intervention group will participate in a 12-week running program and will also continue their routine treatment program. the control group will continue the treatment program as usual.

patients in the inpatient and daycare centers of the psychiatric adolescent department at ziv medical center receive an intensive treatment program including medical management, psychotherapy (individual, groups, and family therapy), and suited educational and other extracurricular recreational activities. despite growing evidence of the effective influence of aerobic physical activity and running therapy, it is not included in the intensive treatment program, and, as far as we know, it is not included in most psychiatric wards in israel. the aim of this study is to assess the effectiveness of combining a group based running therapy as part of the treatment program provided in the inpatient and day care centers of the psychiatric ward. a randomized controlled trial, whereby the intervention group will participate in a 12-week running program and will also continue their routine treatment program. the control group will continue the treatment program as usual. participants will have group running sessions for 1 hour, three times a week, for 12 weeks. sessions will include a psycho-educational short explanation, warm-up, main running exercise, relaxation, and a short summing up discussion. the sessions will be at an open court near the hospital. it will be guided by a team that will address both physical and therapeutic aspects. the intervention program will include running outside the hospital complex (safed stadium) 3 times a week for about an hour each time, for 12 weeks. participants will be transported to the stadium in an organized manner where the therapeutic running training will be conducted by a team that will include the researcher, running coach, nursing staff and psychology students. sessions will include a psycho-educational short explanation, warm-up, main running exercise, relaxation, and a short summing up discussion. at the end of the session, the participants will be driven back to the inpatient ward and day care centers. participants from the intervention group will be given specific group running t-shirts. every week they will be given motivation band bracelets. the control group will be given similar items. also, both groups will be given running shoes.

Eligibility criteria:
inclusion criteria: * 12-18-year-olds. * expected to be under observation for at least 10 weeks at time of recruitment. * consent of the patients and their parents to participate in the randomized control trial exclusion criteria: * acute psychosis or manic states * acute suicidality * extreme physical difficulties * anorexia nervosa
safety and effectiveness of short-course ambisome in the treatment of pkdl in bangladesh

Conditions: Post-kala-azar Dermal Leishmaniasis

Summary: the safety and effectiveness of ambisome 15 mg/kg, given over 15 days in 5 biweekly infusions of 3 mg/kg on an outpatient basis, is evaluated in clinically diagnosed pkdl patients of 12 years and older in a highly endemic area in bangladesh. this is a prospective study, with the objective to assess final cure 12 months after treatment.

the safety and effectiveness of ambisome 15 mg/kg, given over 15 days in 5 biweekly infusions of 3 mg/kg on an outpatient basis, was evaluated in clinically diagnosed pkdl patients of 12 years and older in a highly endemic area in bangladesh. this was a prospective study, with the objective to assess final cure 12 months after treatment. clinical response was monitored at 1, 3, 6, and 12 months after treatment, and safety during and up until one month after treatment. a total of 280 patients recruited between 8 april and 25 november 2014 received ambisome. of these, 272 were assessed at 12 months.

Eligibility criteria:
inclusion criteria: -patients of 12 years and older with probable pkdl (skin lesions strongly suggestive of pkdl with exclusion of other skin diseases, a history of vl treatment and a positive serological rk39 test) exclusion criteria: * pkdl and concurrent vl * prior treatment for pkdl * on medication with a side effect profile overlapping with that of ambisome * a known hypersensitivity to ambisome * pregnant and lactating women, * known cardiac disease, hepatic impairment or another severe chronic underlying disease -renal impairment (baseline serum creatinine \> 1.3 mg/dl) * serum potassium \<3.5mmol/l at baseline

Keywords: post-kala-azar dermal leishmaniasis visceral leishmaniasis ambisome liposomal amphotericin b bangladesh kala azar