Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of monocordil manufactured by laboratórios baldacci

Conditions: Stable Angina

Summary: phase iii clinical study for the evaluation of clinic and cardiologic effects of isosorbide mononitrate from the incidence of events (angina episodes). this is an open, comparative, monocentric trial. the hypothesis, regarding the number of angina episodes, to be tested are: * h0: μd = 0 ot h0: μafter = μbefore * ha: μd ≠ 0 ot ha: μbefore ≠ μafter

phase iii study, monocentric, open, with a single treatment arm in patients with stable angina to evaluates efficacy and safety. the study will be sponsored by pelo laboratórios baldacci. all patients who participate in the study shall sign two copies of the informed consent form. the inclusion of patients is expected to last until 12 months from the approval of the ethics committee and anvisa. follow up will last at least 2 weeks for each included patient. a total of 86 patients will be recruited for this study and all of them will initiate treatment with 20 mg monocordil tablets. after 2 consecutive weeks using the investigational product (+2 days), the patients will be evaluated again, particularly for the parameters under study, this is, quantity and severity of angina episodes and adverse events. the selected patients shall also be 18-80 years old of both genders, with proved diagnosis of stable angina through clinical exams such as ecg, physical effort tests or similar. patients will receive 20mg monocordil tablets (baldacci laboratories). the evaluations will take place in two opportunities: one at the visit of medical evaluation and recruitment in the study (along with the deliver of the study medication and a diary) and the second one after 2 weeks (+2 days) of use of 20mg monocordil tablets for medical evaluation and discharge of the study (return of the diary and medication accountability).

Eligibility criteria:
inclusion criteria: * capacity for understanding and agreement in signing the informed consent form * age 18 between 18 and 80 years old * have a diagnosis of stable angina, proved by ecg, test of physical effort or similar * not being under treatment with other nitrate for stable angina * medical indication for the use of isosorbide mononitrate (monocordil) exclusion criteria: * presence or serious comorbidities (under judgement of the investigator) * allergy to any of the component of the investigational product * pregnant female patients, brest feeding and/or in fertile condition who wish to get pregnant during the study and deny the use of contraceptives

Keywords: stable angina
evaluating the occurence of new and progression of existing peripheral venous disease in leg veins

Conditions: Peripheral Vascular Diseases

Summary: peripheral venous disease occurs when a vein becomes damaged or blocked. it can occur almost anywhere in the body, but is most common in the arms and legs. this study will examine people who participated in a previous venous disease study to evaluate changes in leg veins and venous disease status over a period of 11 years.

peripheral venous disease is a general term for damage, defects, or blockage that occurs in the peripheral veins, which carry blood from the hands and feet back to the heart to receive oxygen. the most common cause of peripheral venous disease is a blood clot that blocks a vein. varicose veins, which are swollen blood vessels near the surface of the skin, and chronic venous insufficiency, a condition in which blood in the leg veins does not drain properly, are two other common types of peripheral venous disease. from 1996 to 2000, the san diego population study (sdps) evaluated a group of individuals to gather information on the prevalence of venous disease. this current study will re-evaluate the sdps participants to document changes that have occurred in their leg veins over the past 11 years, including any new venous disease and any progression of existing venous disease. study researchers will also evaluate how venous disease relates to risk factors, symptoms, and quality of life issues. this study will enroll people who participated in the sdps study. each participant will attend one study visit. study staff will conduct a 1-hour interview with each participant to collect information on their medical history, disease-related symptoms, risk factors for venous disease, family health history, health habits, and quality of life. blood collection will occur, participant's leg veins will be examined and photographed, and blood flow in the legs will be measured with an ultrasound.

Eligibility criteria:
inclusion criteria: * participated in the sdps study

Keywords: venous disease varicose veins chronic venous insufficiency pad
pexelizumab in patients undergoing coronary artery bypass grafting with cardiopulmonary bypass (primo-cabg ii)

Conditions: Coronary Artery Disease

Summary: during a heart bypass procedure, a substance called "complement" is activated by the body. this "complement activation" causes an inflammatory response that can lead to side affects such as chest pain, heart attacks, stroke, heart failure, or death. the purpose of this study is to find out if the study drug (pexelizumab), that blocks "complement activation," can reduce such side effects and be given safely to patients requiring the bypass procedure with the use of the heart-lung machine.


Eligibility criteria:
inclusion criteria: * be at least 18 years of age; * have 2 or more of the following risk factors: • diabetes mellitus; • repeat cabg; • the need for urgent intervention, defined according to the acc/aha guidelines as being patients who are required to stay in the hospital due to medical factors, but may be scheduled and operated on within a normal scheduling routine, excluding patients who have had an mi within 48 hours of cabg; • female; • history of a neurologic event (cerebrovascular accident, transient ischemic attack or carotid endarterectomy); • history of congestive heart failure (nyha chf class iii or iv); • history of 2 mis, or an mi that occurred greater than 48 hours but less than 4 weeks prior to cabg; * provide informed consent. exclusion criteria: * requires salvage intervention as defined by the acc/aha guidelines 10 as being ongoing cardiopulmonary resuscitation on the way to the operating room; * has current cardiogenic shock, acute left ventricular rupture, acute septal rupture or acute papillary muscle rupture; * has any active bacterial or other infection which is clinically significant, in the opinion of the investigator (e.g. evaluate the evidence based on wbc, temperature, cultures etc. as appropriate for the patient); * has a known or suspected hereditary complement deficiency; * has participated in any other investigational drug study or was exposed to an investigational agent or device within 30 days of randomization; * is receiving, or is planning to receive, any other investigational drug or device, or will participate in any other research study within 30 days of randomization; * is pregnant or breast-feeding.

Keywords: cabg cpb
the effect of intravenous lidocaine on pain after tonsillectomy

Conditions: Postoperative Pain

Summary: this prospective randomized study aims to evaluate the effectiveness of intravenous lidocaine injection on the relief of pain in patients undergoing tonsillectomy. a total of 62 patients will be randomized into one of two groups (group c or group i) based on excel number generation. patients in group c will receive received normal saline intravenous injection, and patients in group i will receive an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a continuous lidocaine infusion of 2 mg/kg/hr. visual analogue scale pain scores, fentanyl consumption and the frequency at which patients pushed the button (fpb) of a patient-controlled analgesia system will be recorded at 4, 12, 24, 48 hours postoperatively.


Eligibility criteria:
inclusion criteria: * tonsillectomy exclusion criteria: * mental change * allergy to local anesthetics

Keywords: pain preemptive lidocaine intravenous tonsillectomy
study of bariatric surgery

Conditions: Bariatric Surgery

Summary: the aim of this cohort study is to collect prospectively clinical data on all the patients admitted in the investigators department for bariatric surgery or for any complication of a bariatric procedure. the investigators goal is not only to improve the follow-up but also to assess and publish the investigators results regarding weight loss and the complication rate.


Eligibility criteria:
inclusion criteria: * history of bariatric surgery procedure exclusion criteria: * patients \< 16 years * patients \> 80 years

Keywords: bariatric surgery follow-up weight loss complications comorbidities evolution
is the human microbiome altered in patients with axial spondyloarthritis?

Conditions: Axial Spondyloarthritis; Ankylosing Spondylitis

Summary: this study aims to compare biological communities in stool samples obtained from age, diet and bmi-matched subjects in five study groups: subjects with ankylosing spondylitis (as) never treated with tumor necrosing factor (tnf) inhibitors, subjects with ankylosing spondylitis previously or currently treated with tnf inhibitors, subjects with non-radiographic axial spondyloarthritis (nrspa) never treated with tumor necrosing factor (tnf) inhibitors, subjects with non-radiographic axial spondyloarthritis previously or currently treated with tnf inhibitors and healthy participants. the differences in fecal microbiota composition will be explored using shotgun metagenomic sequencing through the university of washington. the investigators predict that this study will confirm a significant difference between the fecal microbiota composition (fmc) of both as and nrspa patients and controls.


Eligibility criteria:
inclusion criteria: * able to provide informed consent * male or female patients ≥18 years of age * additional inclusion criteria based on cohort exclusion criteria: * current use of any pain-relieving medications other than nsaids, apap and/or opioids * corticosteroid therapy or probiotic exposure within the last two weeks * antibiotic exposure within the past two months * history of psoriasis or inflammatory bowel disease or reactive arthritis or any other chronic rheumatologic disease * active infection * history of hepatitis b or c or hiv * active cancer or history of colon cancer or any form of chemotherapy or radiation within the past year * celiac disease * use of proton pump inhibitors within the prior two months * history of clostridium difficile * pregnancy * active diarrhea (defined as a decrease in fecal consistency lasting four or more weeks) * additional exclusion criteria based on cohort
testing a promising treatment for youth substance abuse in a community setting

Conditions: Substance Abuse; Delinquency; Mental Health

Summary: this study aims to address a serious public health problem (i.e., substance abusing adolescents) by testing the effectiveness of a promising substance abuse treatment implemented in a community-based treatment setting (cm-fam, a family-based contingency management intervention) in comparison to usual treatment services.

the overriding purpose of the randomized trial is to examine the effectiveness of a promising and efficient outpatient treatment of adolescent substance abuse delivered in a community-based treatment setting. although several evidence-based treatments of adolescent substance abuse are emerging, none have experienced widespread adoption in community settings. thus, as noted by the institute of medicine (1998) more than a decade ago and reiterated more recently, a considerable science-service gap exists in regards to treatment of substance abuse in adolescents and adults. for the proposed study, 204 adolescents meeting diagnostic criteria for substance abuse or dependence will be randomized to either the contingency management-family engagement (cm-fam) or treatment as usual (tau) conditions. a multimethod, multirespondent approach will be used to track clinical outcomes at 3, 6, 9, 12, and 18 months post recruitment. clinical level outcomes pertain to youth substance use, criminal behavior, mental health functioning, and key mediators of serious antisocial behavior in adolescents (e.g., self-control, parental supervision, association with deviant peers). in addition, the incremental cost of cm-fam will be determined for use in cost effectiveness analyses. aim 1: over an 18-month post-recruitment follow-up, determine the relative effectiveness of cm-fam vs. tau in reducing adolescent participants' substance use, criminal activity (including incarceration), and mental health symptoms; and evaluate the cost effectiveness of cm-fam in achieving these outcomes. aim 2: examine possible moderators and mediators of intervention effectiveness. moderator variables will include youth demographic and clinical (e.g., co-occurring disorders) characteristics. mediator variables will include measures of self-control, parenting, and association with deviant peers - constructs targeted by cm-fam.

Eligibility criteria:
inclusion criteria: * age of 12-17 years * meeting criteria for substance use or abuse.
quality of life of very preterm children with dysexecutive disorders at elementary school age during the confinement-deconfinement period of covid-19 pandemic

Conditions: Very Preterm Children With Dysexecutive Disorders

Summary: since march 2020, a new hcov, sars-cov2, originating in china, has been spreading around the world. as of 13 may 2020, almost 4.2 million cases of infections and 292 000 died were reported worldwide (140 000 infection cases and 27 000 died in france). human coronaviruses (hcov) usually cause common upper respiratory tract infections in children and sometimes exacerbate lung and asthma diseases. to minimize the risk of contamination of sars-cov2 (covid-19), the french government has put in place directives that modified the daily lives of students, teachers and families. the societal change imposed by the state of health emergency with a confinement and deconfinement period could strongly impact the quality of life of very preterm children with dysexecutive disorders. these children are a population vulnerable to changes, especially during the pivotal period of elementary school. the executive dysfunctions disrupt children's learning and schooling, as well as their social adaptation, compromising their personal development and therefore, their quality of life.


Eligibility criteria:
very preterm children group : * children at elementary school age 7 to 9 * children included in the cohort of epiremed study, born between 24 and 34 weeks' ga (gestational amenorrhea) and having visuospatial working memory impairment defined by a working memory index \<85 from the wppsi iv * children able to read, write and comprehend; * children whose parents are not opposed to the participation in the study * children affiliated to the french social security system control group : * children at elementary school age 7 to 9 * children born at full-term and without dysexecutive disorders * children from the staff of the assistance publique - hôpitaux de marseille (ap-hm) / from the staff of the french mediterranean network (perinat-med) / from the close entourage of epiremed children * children able to read, write and comprehend * children whose parents are not opposed to the participation in the study * children affiliated to the french social security system
muscle parameters and pathological response in breast cancer patients

Conditions: Neoadjuvant Chemotherapy

Summary: the investigators aimed to accurately measure muscle mass and predict pcr to nac and its effect on clinical outcomes.

in patients with operable breast cancer (bc) receiving neoadjuvant chemotherapy (nac), the pathological response rate was found to be related to body composition. the success of complete pathologic response (pcr) is a known prognostic factor in bc patients treated with nac. the investigators aimed to accurately measure muscle mass and predict pcr to nac and its effect on clinical outcomes.

Eligibility criteria:
inclusion criteria: * early and locally advanced operated breast cancer patients receiving neoadjuvant chemotherapy. exclusion criteria: * patients who did not receive neoadjuvant chemotherapy, had metastatic breast cancer and whose radiological images were not available.

Keywords: operable breast cancer skeletal mass index neoadjuvant chemotherapy pathologic response l3 vertebra
comparison of biphasic insulin aspart 70/30 with anti-diabetic drugs in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in the united states of america (usa). the purpose of this study is to test whether biphasic insulin aspart 70/30 is a safe and at least as effective alternative in combination with two oral anti-diabetics compared to the two oral anti-diabetics alone for the control of blood glucose.


Eligibility criteria:
inclusion criteria: * subjects with type 2 diabetes mellitus
circulating tumor dna study in patients with endometrial cancer

Conditions: Endometrial Cancer

Summary: the objective of this study is to identify a population at risk of early recurrence after oncologic resection surgery of a primary uterine tumor based on the detection of ctdna

despite early management, the risk of recurrence in non-metastatic endometrial cancer (figo i-iii) is approximately 10-20%. the challenge is to identify the most high-risk cases for relapse in order to adapt surgical and medical management. the development of digital pcr methods in nano-droplets, detecting circulating tumor dna (ctdna) with high sensitivity, could help to better specify the prognosis of patients with localized endometrial cancer and to identify a population with residual disease, the source of this ctdna. the investigators established a universal methylation signature in the laboratory based on analysis of endometrial cancer-specific dna methylation using in silico analysis of public data from the cancer genome atlas, validated in an independent cohort, with 99% sensitivity and 98% specificity. a prospective biological cohort was established between the gynecology and medical oncology departments and the cochin hospital biological resources center (carpem-oncocentre collection). this is a prospective monocentric biological collection study. the aim of this study is to evaluate the prognostic impact of pre- and post-operative ctdna detection in stage i-iii endometrial cancer.

Eligibility criteria:
inclusion criteria: * female patients over 18 years of age who are potentially eligible for inclusion in the oncocentre collection (registered as a patient at aphp, without legal protection measures, affiliated with a social security system) * patients diagnosed with histologically documented endometrial cancer on an endometrial biopsy * surgical intervention performed at hopital cochin exclusion criteria: * failure to sign the oncocentre consent form * refusal of oncocentre consent * patient not eligible for upfront curative surgical treatment

Keywords: endometrial cancer digital-pcr circulating tumor dna minimal residual disease liquid biopsy
a prospective study on esophagogastrostomy by an innovative surgical technique

Conditions: Gastric Cancer; Adenocarcinoma of Esophagogastric Junction

Summary: this is a single-center, open-label, phase ib/ii study aiming to assess the perioperative safety and postoperative outcomes of a novel surgical technique in treating primary adenocarcinoma located in the upper 1/3 of the stomach or gastroesophageal junction (siewert ii or iii). the study will enroll 30 patients who will undergo totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique. clinical data will be collected to evaluate perioperative safety. patients will be followed for at least 3 months, during which endoscopy will be performed to analyze occurrences and reasons for anastomotic-related complications. additionally, the quality of life after surgery will be evaluated by qlq-c30 and qlq-sto22.


Eligibility criteria:
inclusion criteria: 1. age between 18 and 75 years old; 2. pathologically confirmed as adenocarcinoma; 3. primary tumor located in the upper 1/3 of the stomach or the gastroesophageal junction (siewert ii or iii); 4. if it is adenocarcinoma of the upper 1/3 of the stomach, ct1n0m0 should be met. 5. for gastroesophageal junction adenocarcinoma, ct1-2n0m0 should be met, and clinical judgment should indicate no distant lymph node metastasis around the stomach. 6. bilateral resection margins should be greater than 2 cm, and more than half of the residual stomach should be preserved. 7. no history of upper abdominal surgery (excluding laparoscopic cholecystectomy). 8. no preoperative comprehensive treatments such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc. 9. preoperative ecog (eastern cooperative oncology group) score of 0/1. 10. preoperative asa (american society of anesthesiologists) score i-iii. 11. good function of important organs. 12. signed informed consent. exclusion criteria: 1. preoperative assessment indicating ct4b or bulky lymph nodes enlargement or distant lymph nodes metastasis; 2. pregnant or lactating women; 3. patients with severe mental illness; 4. preoperative temperature ≥38°c or infectious diseases requiring systemic treatment; 5. severe respiratory diseases, with fev1 \< 50% of predicted value; 6. history of other malignant tumors in the past 5 years; 7. severe liver or kidney dysfunction; 8. unstable angina or myocardial infarction within the last 6 months; 9. history of stroke or cerebral hemorrhage within the last 6 months (excluding old infarcts); 10. systemic use of glucocorticoids within the last 1 month; 11. emergency surgery required due to complications of gastric cancer (bleeding, perforation, obstruction); 12. patient has participated in or is currently participating in other clinical trials (within the last 6 months).

Keywords: proximal gastrectomy totally laparoscopic gastrectomy fissure technique
fosamax plus and fosamax plus d re-examination study (0217a-267)

Conditions: Osteoporosis

Summary: this survey is conducted for preparing application materials for re-examination under the pharmaceutical affairs laws and its enforcement regulation, its aim is to reconfirm the clinical usefulness of fosamax plus / fosamax plus d through collecting the safety information according to the re-examination regulation for new drugs. note: fosamax plus d is known as fosamax plus in several markets. fosamax plus (70 mg/2800 iu) and fosamax plus d (70 mg/5600 iu).


Eligibility criteria:
inclusion criteria: * participants who are treated with fosamax plus / fosamax plus d within label for the first time exclusion criteria: * participants who have a contraindication to fosamax plus / fosamax plus d according to the current local label
what is the optimal stiffness and height of a running-specific prosthesis?

Conditions: Amputation, Traumatic; Traumatic Amputation of Lower Extremity; Wounds and Injuries

Summary: the proposed study aims to characterize the effects of running-specific leg prosthetic stiffness and height during on performance during running and sprinting to optimize running-specific prosthesis prescription. the investigators will collect biomechanical and metabolic data from participants with unilateral and bilateral below the knee amputations while they run at different speeds on a treadmill. this data will be used to understand the effects of running prostheses. then, these parameters will be used to develop prosthetic prescription techniques for people with below the knee amputations.


Eligibility criteria:
inclusion criteria: * bilateral or unilateral transtibial amputation * at least one year of running experience using running-specific prostheses * 18-55 years old * no current problems with their prosthesis or residual limb * at a k4 medicare functional classification level exclusion criteria: * cardiovascular, pulmonary, or neurological disease or disorder