Kornimate/medical-research-clean huggingface dataset:
cmts0929 for clostridioides difficile infection

Conditions: Clostridioides Difficile Infection

Summary: this is a prospective, open-label, single-arm study to explore the safety and the efficacy of cmts0929 for patients with clostridioides difficile infection (cdi).

at least 12 subjects who meet all the inclusion criteria but do not meet any exclusion criteria will be enrolled in this study. data of demographic characteristics and clinical data will be collected. after treatment, they will enter the follow-up period for safety and efficacy evaluation.

Eligibility criteria:
inclusion criteria: subjects must meet all of the following inclusion criteria to enter the study: 1. at the time of informed consent, the age is between 18 and 75 years old (inclusive), including both males and non - pregnant, non - lactating females. 2. at the time of screening, meet the diagnostic criteria for clostridioides difficile infection: a)there is a medical record proving a confirmed cdi before screening (laboratory tests show positive results for clostridioides difficile or its toxins): positive results in clostridioides difficile toxin detection (determined by eias) or colonoscopy indicating pseudomembranous colitis; or positive gdh with negative toxin results, along with obvious predisposing factors and diarrhea. b)have an episode of cdi - related diarrhea, that is, having at least 3 bowel movements per day for at least two consecutive days and the stools are unformed (bristol stool form scale score of 6 - 7). 3. the subject or their legal representative provides informed consent, fully understands the purpose of the study, can communicate well with the researcher, and can understand and comply with all the requirements of this study. exclusion criteria: subjects meeting any of the following exclusion criteria must be excluded from the study: 1. subjects with immunodeficiency (such as hiv infection, or absolute neutrophil count \< 0.5×10⁹/l, or total lymphocyte count \< 0.5×10⁹/l, etc.), or those using immunosuppressants, or those using medium - to high - dose steroid hormones (≥20 g/d prednisone or equivalent steroid hormones). 2. subjects with rectal outlet obstruction (such as rectal mucosal prolapse) or significant intestinal stenosis that, as evaluated by the researcher, cannot undergo ctet. 3. before screening, subjects are diagnosed or clinically suspected of having an infection with other pathogenic microorganisms in addition to clostridioides difficile. 4. within 6 months before screening, subjects have undergone major abdominal surgery (excluding laparoscopic cholecystectomy or appendectomy), or have previously undergone partial or total colectomy, or partial small intestine resection, or gastroduodenal surgery. 5. at the time of screening, the subject or legal representative refuses to use effective contraceptive measures within 3 months after the last treatment. 6. as judged by the researcher, the subject is not suitable to participate in this clinical study, or participation in this clinical study cannot guarantee the rights and interests of the subject.

Keywords: cmts0929 clostridioides difficile infection efficacy safety
sentinel low risk registry

Conditions: Aortic Valve Stenosis

Summary: this registry is designed to quantify embolic debris capture rate in patients at low surgical risk treated with the sentinel system during tavi.

the sentinel-lir study is a multicenter, prospective registry to observe rate and type of debris capture in subjects at low surgical risk undergoing tavi to demonstrate the positive effects of the use of the sentinel system. histopathology of captured debris from the sentinel system will be analyzed. the primary objective is to determine the presence or absence of particles of 7 discreet tissue types: acute thrombus (with or without associated tissue/foreign material), organizing thrombus, valve tissue, arterial wall/necrotic core, calcification, foreign material, and myocardium. morphometric assessment of the debris (sizes \>150 m, \>500 m, and \>1,000 m). patients will be screened for inclusion and exclusion criteria and documents which will have been reviewed and approved by the local ethics committee or regulatory authority prior to undergoing any study related exams or procedures. fifty (50) subjects will be enrolled in the study from an estimated 6 different sites.

Eligibility criteria:
inclusion criteria: 1. severe symptomatic aortic valve stenosis 2. planned use of sentinel system 3. subject planned for transfemoral tavi with valve system approved by u.s. fda for low risk patients 4. sts-prom score of less than 4% and agreement by heart team that patients meet criteria for low surgical risk exclusion criteria: 1. current or recent cerebrovascular accident (stroke, tia) \<6 months 2. transapical, direct aortic or subclavian tavi access 3. carotid stenting or endarterectomy in last 6 weeks 4. prior aortic valve replacement 5. concomitant procedure with tavi such as cabg, pci, etc.
prevalence of copd in our lung cancer population, compared to controls

Conditions: COPD; Lung Cancer; Smoking

Summary: this study will investigate the prevalence of chronic obstructive pulmonary disease (copd) in patients who are newly diagnosed with lung cancer and compare it to the prevalence of copd in controls recruited from a smoking cessation clinic.

chronic obstructive pulmonary disease (copd) is a breathing problem that some people develop. usually it is caused by smoking. damage to the lungs means that patients are at risk of more chest infections and are unable to exercise like healthy individuals. they may also have a long-standing cough. copd is diagnosed by testing lung function, usually using a small device called a spirometer. copd is becoming a better understood condition. it is known that the lungs of patients with copd are sometimes inflamed. this is important because inflammation is associated with some types of cancer, including lung cancer. the investigators are interested in whether copd puts people at higher risk of lung cancer. they would like to find out how common copd is in patients who have lung cancer. the investigators would also like to find out how common copd is in patients who are not known to have lung cancer (comparison group). this will help them interpret their results better as investigators will be able to compare the two groups.

Eligibility criteria:
inclusion criteria: * informed consent * aged over 18 * lung cancer group: new diagnosis of lung cancer, with spirometry results available control group: spirometry result available or obtained exclusion criteria: * patient refusal * age under 18 * control group: pre-existing lung cancer
soft tissue augmentation around dental implant

Conditions: Gingival Atrophy

Summary: patients were randomly distributed into two groups (g1 and g2), all patients were treated by a submerged dental implant protocol and free gingival graft (fgg) harvested from the palate as follows: * group 1 (g1), received the fgg two months before implant placement. * group 2 (g2), received the fgg at the time of second-stage surgery (i.e. at the time of healing abutment placement). all periodontal and radiographic assessments were done by the same operator who was neither involved in the evaluation nor the distribution process. the operator did all the evaluation steps and was completely blinded to the treatment protocol.

in this investigation, a randomized clinical trial was employed. the patient's randomization was completed by one of the department's senior residents, who was not involved in the trial and was unaware of any relevant treatment plan. a computer-generated randomization list used a randomization table to perform the randomization (spss v23.0). patients were randomly distributed into two groups (g1 and g2), all patients were treated by a submerged dental implant protocol and fgg harvested from the palate. all patients received a thorough description of all procedures involved in the study. signing a written consent was mandatory for being enrolled in the study. complete medical and dental histories were recorded for all patients and complete clinical intraoral and extraoral examinations were done for all patients. selected patients were questioned about the cause and time of extractions, whether extractions were because of periodontal disease, dental decay or other causes. previous experiences with dental procedures were also discussed. intraoral photographs were taken to record the existing condition of teeth and mucosa before implant placement.

Eligibility criteria:
inclusion criteria: * age: 21 years or older * systemic condition: healthy * keratinized mucosa width: less than 2mm at the intended implant site * bucco-lingual bone width: at least 5.5 mm in a single edentulous space * mesio-distal distance: at least 7 mm between adjacent teeth in a single edentulous space * minimal bone height: not less than 10 mm * residual alveolar ridge: healthy and well-formed, covered with firm mucosa * periodontal health: absence of signs of periodontal bone loss or significant soft tissue .loss in teeth adjacent to the implant site * inter-arch space: adequate, exceeding 7 mm exclusion criteria: * cooperation: uncooperative patients * pregnancy: individuals with known pregnancies * parafunctional habits: abnormal parafunctional habits such as bruxism and clenching * systemic illnesses: patients with systemic illnesses that could disrupt healing * medication: individuals receiving systemic corticosteroids or other drugs impacting .osseointegration or post-operative healing * smoking: smokers consuming more than 10 cigarettes per day
the arcan database is used for retrospective non-interventional research projects. the database collects clinical and laboratory data from patients with lymphoid malignancies. the database doesn't require biological sample of patients, it records only information based on the patients' medical file.

Conditions: Hematologic Diseases

Summary: to identify the diagnostic and therapeutic approach (efficacy and toxicity) of patients with lymphoid malignant hemopathy who are managed in the hematology department.


Eligibility criteria:
inclusion criteria: - patients followed for hematological diseases in lyon sud hospital exclusion criteria: - patients who doesn't have hematological diseases
impact of periodontal treatment on local mirna expression

Conditions: Cardiovascular Diseases; Periodontal Diseases

Summary: to assess the impact of fill mouth scaling and root planing or quadrant scaling and root planing gingival crevicular fluid (gcf) levels of mirna 7a-5p, mirna 21-3p, mirna 21-5p, mirna 100-5p, mirna 125-5p, mirna 200b-3p and mirna 200b-5p and their correlation with periodontitis extent.

the patients selected for the study were divided into 2 groups: group 1 (fm-srp), group 2 (q-srp). any selected subject underwent anamnestic and periodontal examination, blood and gcf sampling. mirna in the gcf was extracted through a commercially available kit and then measured carrying out real-time quantitative polymerase chain reaction (rt-pcr).

Eligibility criteria:
inclusion criteria: * presence of at least 15 teeth * cp with a minimum of 40% of sites with a clinical attachment level (cal) ≥2mm and probing depth (pd) ≥4mm; * presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs * presence of ≥40% sites with bleeding on probing (bop) exclusion criteria: * intake of contraceptives * intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study * status of pregnancy or lactation * previous history of excessive drinking * allergy to local anaesthetic * intake of drugs that may potentially determine gingival hyperplasia such as hydantoin, nifedipine, cyclosporin a or similar drugs.

Keywords: periodontitis, gcf
a study to evaluate ibi112 in the treatment of psoriasis with moderate to severe plaque psoriasis

Conditions: Psoriasis

Summary: the purpose of this study is to evaluate the efficacy and safety of ibi112 in the treatment of participants with moderate to severe plaque-type psoriasis.


Eligibility criteria:
inclusion criteria: 1. diagnosis of plaque-type psoriasis with or without psoriatic arthritis for at least 6 months prior to first administration of any study agent 2. must be a candidate for phototherapy or systemic treatment for psoriasis (either new to treatment or having had previous treatment) exclusion criteria: 1. history of or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease 2. participant has history of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis 3. has received any therapeutic agent directly targeted to il-17within 6 months of the first administration of study agent 4. has received any therapeutic agent directly targeted totnf-a within 3 months of the first administration of study agent 5. has received any conventional therapeutic agent within 1 months of the first administration of study agent 6. has received any topic therapeutic agent within 2 weeks of the first administration of study agent
identifying targets of maladaptive metabolic responses in heart failure

Conditions: Heart Failure

Summary: the purpose of the research is to help researchers understand changes in metabolism in patients that develop heart failure.


Eligibility criteria:
inclusion criteria: 1. subjects are capable of giving informed consent. 2. age 19-89 3. diagnosis of chronic heart failure 4. any patients scheduled for at least one of the following procedures: 1. lvad implantation or as recipient for cardiac transplantation. 2. lvad placement both as bridge to transplant and as destination therapy. 3. lvad explantation 4. valve replacement or repair 5. catheterization and myocardial biopsy for idiopathic cardiomyopathy 6. coronary artery bypass graft (cabg) exclusion criteria: 1. life expectancy less than 2 weeks 2. diagnosed with following co-morbidities: cancer, chronic kidney disease (gfr≤30 or serum creatinine \>2.1), active infection or treatment with antibiotics or persistent infectious disease (hepatitis, hiv, etc), cirrhosis, active substance abuse and/or alcohol dependence (≥ 14 alcoholic beverages per week). control myocardial tissue from donor hearts inclusion criteria 1. samples collected from non-failing hearts deemed unsuitable for transplantation by translife because of either acute recipient issues or post-harvest evidence of pathology or positive but benign serology. 2. normal cardiac function from medical records exclusion criteria: 1. pathological remodeling and extensive infarction with limited non-pathological regions of myocardium. 2. abnormal or impaired cardiac function from medical records, which are self determinants for rejection as a donor organ.
comparison study of blood glucose monitoring systems in people with diabetes

Conditions: Diabetes Mellitus

Summary: a multicentre study comparing 5 different self-monitoring of blood glucose (smbg) system commercially available in germany \& holland.


Eligibility criteria:
inclusion criteria: * subjects diagnosed with type 1 or type 2 diabetes mellitus * age between 18 and 75 years. * patients with stable blood glucose in judgment of the investigator. * subjects receive intensive insulin therapy (multiple daily injection defined as at least two insulin injections per day) * patients perform blood glucose self measurements on a routine basis * patients must have experience in self measurement blood glucose for at least 6 months. exclusion criteria: * patients with unstable blood glucose in judgment of the investigator. * patient has been diagnosed with progressive / serious diseases that in judgment of the investigator preclude successful completion of the observational period. * lack of compliance or other justifications that, in the discretion of the investigator, precludes satisfactory participation in the study. * subject without legal capacity. * blood donation within the last 30 days. * known pregnancy. * subject has already participated in the study.

Keywords: diabetes, smbg, glucose testing systems, accuracy
sct in ph positive acute lymphoblastic leukemia

Conditions: Philadelphia Positive Acute Lymphoblastic Leukemia; SCT

Summary: this study includes a registry-based, nationwide analysis to describe the clinical outcome of adult patients with philadelphia chromosome-positive acute lymphoblastic leukemia (ph+ all) who underwent an allogeneic hematopoietic stem cell transplantation (hsct) after a tyrosine kinase inhibitors (tki)-based treatment.

this was a retrospective nationwide analysis based on registry data collected by gitmo. inclusion criteria were: 1) diagnosis of ph+ all; age ≥18 years at transplant; 2) patients receiving first allogeneic hsct from any donor (hla-identical sibling donor (msd), unrelated donor (ud) or alternative donor (haploidentical or cord blood) between 2005 and 2016 in a gitmo center; 3) tki-based treatment prior to hsct; 4) patients with available pre-transplant mrd status, as well as complete clinical data and outcome. data were extracted from the gitmo registry (promise registry). the endpoints of the study were: os, progression-free survival (pfs), cumulative incidence of relapse (cir), non-relapse mortality (nrm), cumulative incidence of extensive chronic graft versus host disease (cgvhd), rate of minimal residual disease (mrd) negativity and the rate of complete cytologic remission (cr) before and after transplant.

Eligibility criteria:
inclusion criteria: * diagnosis of ph+ all; age ≥18 years at transplant. * patients receiving first allogeneic hsct from any donor (hla-identical sibling donor (msd), unrelated donor (ud) or alternative donor (haploidentical or cord blood) between 2005 and 2016 in a gitmo center. * tki-based treatment prior to hsct. * patients with available pre-transplant mrd status, as well as complete clinical data and outcome. exclusion criteria: * all cases without one or more of inclusion criteria.
effects of walnut-enriched diet on blood lipids and glucose profiles in hyperlipidemic subjects

Conditions: Hyperlipidemias

Summary: walnuts have been shown to reduce serum lipids in hyperlipidemic individuals with a well-controlled feeding trials. current study have been determined the effects of daily walnut consumption on serum lipids, fasting glucose and insulin levels in hyperlipidemic individuals.

in this, randomized controlled trial, mild to moderate hyperlipidemic subjects were randomly divided into 2 groups as walnut-enriched (n=20) and control (n=17) groups for 6 weeks. all subjects adhered to a medical nutrition therapy as low-fat and low-cholesterol diet. the walnut-enriched group was supplemented with 40 g/day of walnuts added to their diets. in order to follow nutritional status of subjects, they were visited every 15 days (in total 4 times). anthropometric measurements of the subjects were taken and were monitored at each visit during the study. blood samples were measured at the beginning and again at the end of the study.

Eligibility criteria:
inclusion criteria: * hyperlipidemic patients who are not using any lipid lowering medications * non-smoker * no alcohol consumption * individuals who are having ≤30kg/m2 * individuals who do not have any allergy for nut consumption * female participants who are not pregnant or breastfeeding * individuals should not be in a weight loss programme * having not consumed regular nuts for the last 1 month, * except hypertension, they should not have other chronic diseases (such as diabetes, chronic renal failure) * no intense exercise exclusion criteria: * failure to meet the criteria for inclusion criteria.

Keywords: serum lipids hyperlipidemia walnut
monitoring and mapping of erectile nerve during ralp (mmen study)

Conditions: Prostate Cancer

Summary: to evaluate the safety and efficacy of pelvic autonomic nerve monitoring and mapping during robot assisted laparoscopic radical prostatectomy for preservation of erectile function.

using nim-eclipse monitoring instrument (medtronic), we will check action potential of cavernous nerve, bulbocavernosus reflex and pudendal nerve somatosensory evoked potential in real time during robot assisted laparoscopic radical prostatectomy for preservation of erectile function. in this feasibility and protocol setting phase i/ii study, we will evaluate the safety and efficacy of pelvic autonomic nerve monitoring and mapping using nim-eclipse monitoring instrument.

Eligibility criteria:
inclusion criteria: * pathologically proven localized prostate cancer (≤ct3a) * patients to undergo robot-assisted laparoscopic prostatectomy at our center exclusion criteria: * prior hormone therapy * prior radiation treatment on prostate or pelvis * refused to participate

Keywords: prostate cancer, robot, nerve mapping and monitoring
safety and efficacy study of nggt001 in bietti crystalline corneoretinal dystrophy subjects

Conditions: Bietti Crystalline Corneoretinal Dystrophy

Summary: the objective of this study is to evaluate the safety, tolerability, and efficacy of subretinal injection of nggt001 in patients with bietti crystalline corneoretinal dystrophy (bcd) and to recommend the optimal dosage for future clinical administration.


Eligibility criteria:
1. age ≥ 18 years old. 2. male or female. 3. confirmed diagnosis of bcd. 4. molecular diagnosis confirmed cytochrome p450 family 4 subfamily v member 2 (cyp4v2) mutation. 5. aav2 neutralizing antibody titer ≤1:5120. 6. 0.05 ≤ best corrected visual acuity (bcva) ≤ 0.3. 7. -6.00d ≤ refractive error ≤ +3.00d. 8. agree to take contraceptive measures from the start of the study until one year after medication administration. 9. volunteer to participate in the study and sign informed consent. exclusion criteria: 1. there are choroidal neovascularization or other ocular diseases caused by bcd, which are considered to affect the operation or interfere with the interpretation of clinical endpoint. 2. patients with evidence of neovascularization or suspected neovascularization, and the presence of tubular reflectivity in the neuroepithelial layer as shown by oct. 3. those who had used any of the treatment drugs within 6 months before enrollment, such as lucentis, avastin, conbercept, triamcinolone acetonide, etc. these may affect the experimental observation. 4. the treated eyes have undergone intraocular surgery, such as photodynamic therapy (pdt), vitrectomy, periocular vascular bypass surgery, etc., or need intraocular surgery in the process of clinical research, such as cataract surgery, retinal laser therapy, etc. 5. have used or may use systemic drugs that may cause eye damage, such as psoralen, tamoxifen, etc. 6. highly sensitive or allergic to ingredients in the test drug (with allergic history of two or more drugs or food). 7. physical examination, vital signs, and laboratory examination (such as blood routine, urine routine, blood biochemistry, coagulation function, immunology examination, etc.) are abnormal and clinically significant, or the investigators believe that the abnormal indicators have clinical significance. 8. there are diseases or medical histories that may affect drug safety or in vivo processes, especially cardiovascular, liver, kidney, endocrine, digestive tract, lung, nerve, blood, tumor, immune or metabolic disorders considered by investigators to be of clinical significance. 9. participated in clinical trials of other drugs or medical devices within three months before enrollment. 10. female patients who are pregnant or lactating. 11. any other conditions which lead the investigator to determine the participant is unsuitable for this study.

Keywords: bcd bietti crystalline corneoretinal dystrophy