Kornimate/medical-research-clean huggingface dataset:
biosynthetic absorbable mesh vs standard of repair for the surgical treatment of infected incisional hernia

Conditions: Ventral Hernia Repair

Summary: incisional hernia is one of the most common complications of abdominal surgery and carries a significant burden for both patients and the economic health service. however, no consensus for the surgical treatment of incisional hernia in contaminated field is currently available. the purpose of the compact-bio study is to investigate the clinical and economic benefit of the use of biosynthetic mesh in contaminated incisional hernia repair.

the current standard of incisional hernia repair is reinforcement with permanent synthetic mesh. however, permanent synthetic mesh is contraindicated in contaminated surgical field due to higher risk of postoperative infection. in order to resist to infection, absorbable meshes, such as biological and biosynthetic meshes, have been developped. however, some controversies exist about the clinical benefit of biological meshes in the long term. reasons for theses controversies are their overall risk of complication and recurrence and the lack of consensus in which surgical technique to apply. moreover, the financial cost of biological meshes is very high. recently developed, biosynthetic meshes appear to be a promising option ; compared to biological meshes, they seem to have several advantages. however, such data demonstrating the beneficial use of biosynthetic mesh in contaminated incisional hernia repair is not available. in this regard, the compact-bio study aims to investigate the clinical and economic benefit of the use of biosynthetic mesh in contaminated incisional hernia repair in comparison to the standard of repair. this is a multicenter, prospective, longitudinal and randomized study, which also offers a standardized technique of repair.

Eligibility criteria:
all the following inclusion criteria must be fulfilled: * age ≥18 years old * physical status asa \< 4 * patient with a mid-line ih * patient presenting with an ih without loss of domain * surgical indication in elective surgery * "potentially contaminated" grade iii surgical environment according to the classification of the modified vhwg * cure of mid line ih feasible according to the defined standard technical modality (placement of a retromuscular prosthesis) * no emergency surgical procedure * status of social insured or entitled to a social insurance * informed and signed consent of the patient after clear and appropriate information the exclusion criteria are as follows: * one or multiple incisional hernia out of the midline incision * pregnancy, breastfeeding, parturient or childbearing patients without contraception * known allergy to tetracyclines; * persons protected by law

Keywords: ventral hernia repair contaminated surgical field infected incisional hernia biosynthetic mesh
impact of physical therapy of dysphagia on preventing pneumonia in acute stroke patients

Conditions: Stroke, Acute; Dysphagia; Pneumonia

Summary: to investigate the impact of physical therapy intervention of dysphagia on preventing pneumonia in acute stroke patients

seventy acute ischemic cerebrovascular stroke patients suffering from dysphagia were selected from the stroke unit in el-kasr el ainy hospital. their ages ranged from 49 -65 years. stroke dysphagia was diagnosed by a neurologist. gugging swallowing screen and a2ds2 score was used to assess risk of developing pneumonia. stroke associated pneumonia was diagnosed by: recommended diagnostic criteria for definite and probable sap in patients not receiving mechanical ventilation based on the cdc criteria. the selected patients were randomly assigned into two equal groups control group (a) and study group (b). control group (a) was treated by nasogastric tube and oral care. study group (b) was treated as the control group in addition to a designed physical therapy program consisting of neuromuscular electrical stimulation in addition to exercises for oropharyngeal muscles. assessment was done before treatment, at the middle and at the end of treatment for each patient. treatment was conducted for five sessions per week for one month.

Eligibility criteria:
inclusion criteria: * all patients were diagnosed of stroke dysphagia by a neurologist. * severity of stroke ranged from mild to moderate according to nihss score (nihss less than or equal 16). * patients' age ranged from 49 to 65 years old. * patients had the ability to understand and follow instructions. * patients were able to sit in upright position. exclusion criteria: * history of previous stroke. * history of any swallowing problem. * history of any disease, head and neck surgery or tumor that causes swallowing dysfunction. * any lung disease or pneumonia on admission. * patients with cognitive deficits or disturbed conscious level. * patients on mechanical ventilator. * patients with sensory or global aphasia.
narrow band imaging (nbi): a novel imaging modality in minimally invasive

Conditions: Endometrial Cancer; Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cancer; Gastrointestinal Carcinoma; Pancreatic Carcinoma; Lung Cancer; Esophageal Carcinoma

Summary: the purpose of this study is to determine whether narrowband imaging (nbi) makes it easier for a surgeon to see cancer. nbi is a kind of light. normally, white light is used during surgery. white light uses many wavelengths of light. nbi only uses two wavelengths which highlight the blood vessels. this makes it easier for the surgeon to see blood vessels. tumors often have more blood vessels than normal tissue. as a result, nbi may make it easier for the surgeon to see small tumors. in this study the surgeon will look with both normal white light and nbi. this way a comparison can be made to determine which is superior. improved identification of tumors allows doctors and patients to make informed decisions about whether treatment is needed after surgery. it also provides additional information to determine which treatments may be best.


Eligibility criteria:
inclusion criteria: * patients must meet one (or more) of the following criteria: * preoperative diagnosis of ovarian, fallopian tube, or primary peritoneal carcinoma (all stage, grade and histology) * preoperative diagnosis of grade iii endometrial carcinoma (all stage, all histology) * preoperative diagnosis of uterine serous carcinoma (all stage, all grade) * preoperative diagnosis of clear cell endometrial carcinoma (all stage, all grade) * preoperative diagnosis of endometrial carcinosarcoma (all stage, all grade) * gastrointestinal carcinoma (all histology, stage and grade) * pancreatic carcinoma (all histology, stage and grade) * lung cancer (all histology, stage and grade) * esophageal carcinoma (all histology, stage and grade) * suspected or pathologically confirmed metastatic disease to the lung (all disease primaries) * suspected or pathologically confirmed malignant pleural effusion (all disease primaries) patients must meet all of the following criteria: * planned thorascopic robotic or laparoscopic surgical approach * \>18 years old * not pregnant * able to give consent participation in other research protocols does not exclude a patient from participation in this study. exclusion criteria: * none

Keywords: nbi endometrium fallopian tube ovary peritoneum surgery lung pancreatic esophageal thorascopic laparoscopic robotic 10-180
extension study in a cohort of adult patients with covid-19 infection

Conditions: COVID-19 Infection

Summary: the main objective of this study is to evaluate the incidence of post-covid morbidity and characterize the complications profile in patients who participated in the aplicov-pc study. aplicov-pc study was a multicenter, randomized, proof-of-concept clinical trial to assess the safety profile of 3 different dose levels of plitidepsin (1,5 mg, 2,0 mg and 2,5 mg) administered three consecutive days, in adult patients with confirmed diagnosis of covid-19 who require hospital admission.

the aplicov-pc proof of concept study demonstrated the antiviral activity of plitidepsin in terms of reducing viral load, inducing recovery, and impact on lymphocyte reconstitution and other inflammatory parameters. a percentage of patients, which varies between 10 and 25%, continue to show symptoms at 3 months after contracting the severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection: for some of them this significantly restricts their life, requiring them to take long-term sickness leave from work, and leaving them with sequelae that may continue for more than one year. with this study, pharmamar intends to evaluate whether the treatment with plitidepsin, by attaining a reduction in the viral load and a faster recovery of the patient, could have a relevant impact on the emergence of sequelae resulting from the sars-cov-2 infection.

Eligibility criteria:
inclusion criteria: * patient who participated in the aplicov-pc study receiving treatment with plitidepsin and who gives consent. exclusion criteria: * there are no exclusion criteria for this study.

Keywords: plitidepsin covid-19 post-covid morbidity
effects of hqk-1001 in patients with sickle cell disease

Conditions: Sickle Cell Disease; Sickle Cell Anemia; Sickle Cell Disorders; Hemoglobin S Disease; Sickling Disorder Due to Hemoglobin S

Summary: the purpose of this study is to evaluate the effects of hqk-1001 on hb f in subjects with sickle cell disease.


Eligibility criteria:
inclusion criteria: * males and females between 12 and 60 years of age * diagnosis of scd, type hb ss or hb s-b0 thalassemia * at least 1 episode of scd pain crisis, acute chest syndrome, other acute scd complications, or leg ulcers in the 12 months prior to screening * not being treated with hydroxyurea (hu); if hu treatment has been previously administered and then discontinued, at least 3 months must have elapsed since last dose of hu * if subject has been transfused in the 3 months prior to screening, then hb a level \< 20% at screening * baseline hb f level obtained within 14 days prior to randomization * able to swallow tablets * able and willing to give informed consent and/or assent * if subject is a woman of child-bearing potential (wcbp), she must have a negative serum pregnancy test within 14 days of first dose of hqk-1001 and a negative urine pregnancy test prior to dosing on day 1 * if a subject is a wcbp, she must agree to use an effective form of contraception starting at screening and for one month after hqk-1001 discontinuation * sexually active male subjects who have not had a vasectomy must agree to use latex condoms with wcbp partners or ensure that their partner(s) use an effective form of contraception starting at screening and for one month after hqk-1001 discontinuation. exclusion criteria: * assigned to a regular transfusion program * use of erythropoiesis stimulating agents within 90 days prior to screening * an scd pain crisis or scd-related acute complication within 3 weeks prior to randomization * more than 5 scd pain crisis or scd-related acute complications within 12 months prior to screening * pulmonary hypertension requiring therapy * alt or ast \> 3x uln * serum creatinine \> 1.5x uln * serum amylase levels \> 1.5x uln * serum lipase level \> 1.5x uln * a serious, concurrent illness that would limit ability to complete or comply with the study requirements * an acute illness (e.g., febrile, gi, respiratory) within 72 hours prior to screening * history of syncope, clinically significant dysrhythmias or resuscitation from sudden death due to scd-related complication * symptomatic peptic ulcer, hiatus hernia, or gastroesophageal reflux disease (gerd) * history of pancreatitis * chronic opiate use, which, in the view of the investigator, could confound evaluation of an investigational drug * current abuse of alcohol or drugs * use of another investigational agent within 4 weeks or 5 half-lives, whichever is longer, prior to screening * currently pregnant or breast feeding a child * known infection with hiv-1 * infection with hepatitis b or hepatitis c, such that subjects are currently on anti-viral therapy or will be placed on therapy
relationships between plasma pcsk9 levels, ldl-cholesterol concentrations and lipoprotein (a) levels in familial hypercholesterolemia

Conditions: Familial Hypercholesterolemia

Summary: familial hypercholesterolemia (fh) is an autosomal codominant single gene disorder caused by mutations in the ldl receptor gene (ldlr) that disrupt the normal clearance of ldl particles from the plasma. heterozygous patients (hefh) present a two- to three-fold raise in plasma ldl-cholesterol (ldl-c) concentrations and coronary artery disease occurs earlier among hefh carrying negative-receptor (nr) mutations as compared with hefh subjects carrying defective-receptor (dr) variants. proprotein convertase subtilisin/kexin type 9 (pcsk9) regulates ldl-c levels by binding to ldlr and by enhancing its intracellular degradation. the objective of this study is to examine to what extent variations in ldl-c and lipoprotein (lp) (a) concentrations are related to pcsk9 levels in a large french-canadian cohort of hefh subjects. the primary hypothesis is that that pcsk9 levels have a significant impact on ldl-c concentration variability and are associated with lp(a) levels.


Eligibility criteria:
inclusion criteria: subjects with familial hypercholesterolemia: * aged between 18-65 years * carrier of a mutation in the ldl receptor gene controls: * aged between 18-60 years * hdl-cholesterol \> 1.1 mmol/l * triglycerides \< 1.7 mmol/l * fasting blood glucose \<6.1 mmol/l * normal blood pressure (\<130/85) exclusion criteria: * subjects with a previous history of cardiovascular disease * subjects with type 2 diabetes * were pregnant or nursing; * subjects with a history of cancer * subjects with acute liver disease, hepatic dysfunction, or persistent elevations of serum transaminases * subjects with a secondary hyperlipidemia due to any cause * history of alcohol or drug abuse within the past 2 years * hormonal treatment * subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study
evaluation of the effectiveness of the self-developed pulmonary lobar ventilation detector

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the goal of observational study is to evaluation of the effectiveness of the self-developed pulmonary lobar ventilation detector in chronic obstructive pulmonary disease. the main question it aims to answer are:evaluation of the effectiveness of the self-developed pulmonary lobar ventilation detector. participants will use the self-developed pulmonary lobar ventilation detector and the imported chartis detection system to evaluate the target pulmonary lobar collateral ventilation.


Eligibility criteria:
inclusion criteria: * patients with chronic obstructive pulmonary disease who meet the gold diagnostic criteria * fev1 ≤ 45% pred and fev1/fvc\<70% * tlc\>100% pred and rv\>175% pred * cat≥18 * \>50% of emphysema destruction * smoking prohibition\>6 months * sign the informed consent form exclusion criteria: * paco2\>8.0 kpa, or pao2\<6.0 kpa * 6-minute walking test\<160m * obvious chronic bronchitis, bronchiectasis or other infectious lung diseases * three hospitalizations due to pulmonary infection in the past 12 months before the baseline assessment * previous lobectomy, lvrs or lung transplantation * lvef\ 50mmhg * anticoagulant therapy that cannot be stopped before surgery * the patient has obvious immune deficiency * participated in other lung drug studies within 30 days before this study * pulmonary nodules requiring intervention * any disease or condition that interferes with the completion of the initial or subsequent assessment
a study of ibandronate (bonviva) in patients with post-menopausal osteoporosis

Conditions: Postmenopausal Osteoporosis

Summary: this study will evaluate participant-reported preference for either ibandronate or a comparator drug in women with postmenopausal osteoporosis. the anticipated time of study treatment is 6 months, and the target sample size is 338 individuals.


Eligibility criteria:
inclusion criteria: * ambulatory women * diagnosis of post-menopausal osteoporosis * women who have never received bisphosphonate therapy, or who have discontinued daily bisphosphonates at least 3 months prior to study entry exclusion criteria: * inability to stand or sit in the upright position for greater than or equal to 60 minutes * allergy to bisphosphonates; * previous or current treatment with weekly or monthly bisphosphonates, or daily bisphosphonates for the last 3 months prior to study entry
allogeneic stem cells implantation combined with coronary bypass grafting in patients with ischemic cardiomyopathy

Conditions: Coronary Artery Disease; Ischemic Cardiomyopathy

Summary: the aim of the present study is to investigate safety and efficacy of intramyocardial implantation of a novel mesenchymal precursor cell type (imp) in patients with ischemic cardiomyopathy at the time of coronary artery bypass grafting.

this study aims to investigates in situ cardiac regeneration utilizing precision delivery of a novel mesenchymal precursor cell type (imp) during coronary artery bypass surgery (cabg) in patients with ischemic cardiomyopathy (lvef \< 40 %). preoperative scintigraphy imaging (spect) will be used to identify hibernating myocardium not suitable for conventional myocardial revascularization for imp implantation. imp cells will be implanted intramyocardially in predefined viable peri-infarct areas that show poor perfusion, which could not be grafted due to poor target vessel quality. postoperatively, spect will be used to identify changes in scar area.

Eligibility criteria:
inclusion criteria: * age from 18 to 75 years * severe coronary artery disease amenable to surgical revascularization according to current guidelines * history of acute myocardial infarction at least 14 days previously * left ventricular ejection fraction (lvef) ≤ 40% as assessed with echocardiography * distinct area of dyskinetic or akinetic left ventricular myocardium corresponding with the infarct localization * patient's informed consent obtained exclusion criteria: * emergency operation * debilitating chronic disease (eg. malignancy or terminal renal failure) * concomitant valve surgery * previous cardiac surgery * malignant ventricular arrhythmias * haematologic disease * woman in reproductive age * severe psychiatric illness

Keywords: coronary artery disease heart failure stem cells implantation
study to assess satisfaction with modafinil treatment in children and adolescents with adhd

Conditions: ADHD

Summary: an 8-week, open-label study to characterize the response to modafinil (85mg film-coated tablet) treatment at dosages up to 425mg/day in children and adolescents with attention-deficit/hyperactivity disorder (adhd) (with an open-ended extension period)


Eligibility criteria:
inclusion criteria: patients are included in the study if all of the following criteria are met: * written informed consent/assent is obtained. * the patient is a boy or girl 6 through 17 years of age (inclusive) at the screening visit, and both the patient and parent/legal guardian are english-speaking. * the patient has a previous diagnosis of adhd and is currently receiving medication for the treatment of adhd. * the patient, or the patient's parent/legal guardian, is dissatified (vas score \<50) with current adhd medication (medication and reason for dissatisfaction documented). * the patient is in good health as determined by a medical or psychiatric history, screening physical examination, and clinical laboratory evaluations. * girls who are postmenarche or sexually active, must have a negative urine pregnancy test prior to the baseline visit, must be using a medically acceptable method of birth control, and must agree to continue use of this method for the duration of the study (and for 30 days after participation in the study). acceptable methods of birth control include the following: barrier method with spermicide; steroidal contraceptive (eg, oral, transdermal, implant, or injected) in conjunction with a barrier method; intrauterine device (iud); and abstinence. * the patient's parent/legal guardian must be willing and able to comply with study procedures and restrictions. exclusion criteria: patients are excluded from participating in this study if 1 or more of the following criteria are met: * the patient has any current psychiatric comorbidity, including but not limited to depression or other mood disorder, or pervasive mental disorder, that requires pharmacotherapy. * the patient is satisfied with current adhd medication and has no side effects. * the patient is using other prescription medications for adhd with psychoactive properties (eg, amphetamine, dextroamphetamine, methylphenidate, pemoline, atomoxetine) after the baseline visit. * the patient has used monoamine oxidase (mao) inhibitors within 1 week before the baseline visit. * the patient has used an investigational drug within 1 month before the screening visit. * the patient has a known clinically significant drug sensitivity to modafinil or any of its inactive ingredients. * the patient is pregnant or lactating. (any patients becoming pregnant during the study will be withdrawn from study).
evaluation of the efficacy of the sequencing method by gene-panel

Conditions: Primary Immuno-Deficiencies

Summary: in order to accelerate the identification of genes responsibles of pid, and to improve the diagnosis of pid, the research team would like to validate a rapid and targeted method of high-throughput sequencing, on 301 genes, known to be involved in pid.

the primary immuno-deficiencies (pid) are a set of rare diseases (estimated incidence of 1/5000). today, more than 320 pid are described, and for 301 of them, the genetic cause has been identified, which underlines the huge diversity of all pid. the genetic diagnosis of pid is very important for the comprehension of pid physiopathology, their treatment and the genetic patient information. the characterisation of the clinical and immunological phenotype of patients allowed to identify a known morbid gene in 30% of cases, but for other patients, the genetic cause remains unknown, due to, inter alia, the lack of efficient tools for genetic exploration. in this context, each year, around 600 french and foreign patients are explored at the necker hospital cedi (center for immuno-deficiencies explorations), for whom are identified, in 30% of cases, a known genetic cause. their treatment and the diagnosis of these patients is slow, partially because these studies are dependants of research fundings. in addition, in the current practice, the investigators sometimes discover incidental findings via the non-targeted high throughput genetic analyzes. the aim of the gene-panel is to improve the diagnosis procedures of these known diseases, by generalizing a rapid and targeted method of sequencing, on 301 genes, known to be involved in pid.

Eligibility criteria:
inclusion criteria: * patient who need a genetic diagnosis of pid done at necker's cedi (center for immuno-deficiencies explorations), in the frame of an initial causal mutation identification * patient having signed an informed consent form (or parents for minor patients) * patient affiliated to national health care insurance exclusion criteria: * patient refusing to participate * patient under legal guardianship * patient that can't fulfill the study requirements, for any geographic, social or psychic reason