Kornimate/medical-research-clean huggingface dataset:
mitomics : a multi-omics approach for the diagnosis of mitochondrial diseases

Conditions: Mitochondrial Diseases

Summary: mitomics aims to determine which rna-seq results (from muscle or fibroblasts) are the most informative for the interpretation of vus identified by wes for patients suspected of mitochondrial myopathy. analysis of rna-seq and wes results will performed with a computational approach using an autoencoder-based method

mitochondrial diseases (md) are rare, clinically and genetically extremely heterogeneous, caused by a deficit of energy production via the mitochondria. mitochondria are dependent on 2 genomes mitochondrial dna and nuclear dna, and many pathogenic variants carried by these 2 genomes are responsible for mitochondrial diseases. the diagnostic strategies for md patients have evolved significantly with the emergence of next generation sequencing (ngs) also accelerating the identification of the responsible gene. however, the diagnostic yield remains limited and requires the development of new approaches. previous studies showed that wes and rna-seq combination improves the diagnosis of md, essentially by helping in the interpretation of identified vus. with mitomics project, we will included 66 patients suspected of a mitochondrial myopathy (clinical, histological or biochemical), with a negative mtdna and wes ngs in trio. for each patient we will sequenced rna from muscle and fibroblasts. using a new innovative methology of multi-omics integration we will determined which rna-seq data (from muscle or fibroblasts) are the most informative for the interpretation of vus identified by wes for patients suspected of mitochondrial myopathy. the results obtained will allow the interpretation of vus and the identification of specific molecular signatures.

Eligibility criteria:
inclusion criteria: * patients suspected of a mitochondrial disease with muscular signs (clinical, histological or biochemical) * patients with negative mtdna and wes ngs in trio * patients with routine muscle and skin biopsies available * blood samples from parents and / or relatives available for segregation studies * informed consent of the study signed by the patient or the legal representatives of the minor patient or under guardianship * patients affiliated to social security exclusion criteria: * patients with suspected mitochondrial disease without muscle involvement * patients for whom the mtdna ngs and wes have not been performed * patients with suspected mitochondrial disease with causal variant identified * refusal to sign the informed consent for the study * insufficient amount of frozen material or culture failure for fibroblasts
comparison of effectiveness between the combination of lidocaine sprayed at laryngeal inlet and on the cuff of endotracheal tube versus intravenous lidocaine for reducing cough during extubation

Conditions: Reducing Cough During Extubation

Summary: coughing during extubation of endotracheal tube (ett) is a common problem that leads to poor surgical results including hemodynamic change, rebleeding at the surgical wound and wound dehiscence. recently, lidocaine has been introduced for reducing coughing during extubation. however, data comparing routes of lidocaine application are lacking, thus, this study compared the combination of lidocaine sprayed on laryngeal inlet and cuff of ett versus intravenous lidocaine injection for efficacy in reducing coughing

a prospective randomized control trial was conduct with 164 patients. they were randomly allocated into gr. a and b. group a received four puffs of 10% lidocaine sprayed at the cuff of ett and four puffs at laryngeal inlet whereas gr. b received 15 mg/kg of 2% lidocaine intravenous injection prior to extubation. the same general anesthesia protocol was applied in all of the patients. incidence and severity of cough during extubation was evaluated. furthermore, incidence of 24-hour postoperative adverse events (including sore throat, dysphagia, and hoarseness) and hemodynamic response after extubation were analyzed.

Eligibility criteria:
inclusion criteria: * patients who underwent elective surgery with american society of anesthesiologists physical status classifications of i and iii exclusion criteria: * patients having body mass index more than 35 kg/m2, high risk of aspiration, chronic smokers more than ten pack-years, chronic cough or recent upper respiratory infection, suspected difficult airway, retained ett prior surgery, surgery at oral cavity, neck and thoracic region, operative time more than 120 minutes or less than 30 minutes, and history of lidocaine allergy
second line chemotherapy for advanced pancreatic cancer

Conditions: Pancreatic Adenocarcinoma

Summary: no validated second-line chemotherapy for the treatment of locally advanced/metastatic pancreatic cancer is actually available,after the failure of a gemcitabine(+/- cisplatin or oxaliplatin)-based regimen. irinotecan seems to be a moderately active drug in the treatment of this disease recently was reported some interesting results using a potentially non -cross resistant regimen (folfiri) which could be useful even as second-line chemotherapy. an exploratory study in this setting seem warranted.


Eligibility criteria:
inclusion criteria: * signed written informed consent prior to beginning protocol specific procedures * previous chemotherapy with gemcitabine plus or less platinoids * previous gemcitabine delivered as a radiosensitizer for locally advanced disease, followed or not by a gemcitabine plus or less platinoids as maintenance or disease progression is allowed. * male or female less than 75 years of age * diagnosis of histologically or cytologically confirmed adenocarcinoma of the pancreas * locally advanced (non-resectable) or metastatic pancreatic cancer * presence of at least one uni-dimensional indicator lesion measurable by ct scan or mri in not an irradiated area * ecog performance status 0 to 1 at study entry * life expectancy: more than 3 months * neutrophils more than 1.5 x 109l, platelets more than 100 x 109l, and hemoglobin more than 10 gdl * bilirubin level either normal or less than 1.5 x uln * asat and alat normal or less than 2.5 x uln (normal or less than 5 x uln if liver metastasis are present) * serum creatinine less than 1.5 x uln * amylase normal or less than 1.5 uln * effective contraception for both male and female patients if the risk of conception exists * absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial exclusion criteria: * brain metastases * previous treatment with irinotecan or fluoropyrimidines * significant cardiovascular disease: clinically relevant coronary artery disease or a history of a myocardial infarction within the last 6 months * significant gastrointestinal abnormalities * gilbert's syndrome * any uncontrolled infections * known hiv infection * radiotherapy within 4 weeks prior to study entry * any investigational agents 4 weeks prior to entry * known grade 3 or 4 allergic reaction to any of the components of the treatment * known drug abuse or alcohol abuse * medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent * women who are pregnant or breastfeeding * any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. * legal incapacity or limited legal capacity

Keywords: folfiri metastases pancreatic adenocarcinoma locally advanced or metastatic pancreatic adenocarcinoma
study evaluating safety and tolerability of vabicaserin in patients with sudden worsening of schizophrenia

Conditions: Schizophrenia

Summary: this study will evaluate the clinical safety and tolerability of vabicaserin in japanese subjects that have a sudden worsening of their symptoms of schizophrenia. the study will also assess the efficacy of vabicaserin and compare it to risperidone.


Eligibility criteria:
inclusion criteria: * male and female subjects between \>=20 and =\<65 years of age * current diagnosis and dsm-iv-tr diagnosis of schizophrenia type (295.10, 295.30 and 295.90) * total panss score \>=70 and =\< 120 exclusion criteria: * subjects who are hospitalized against their will * current axis i primary psychiatric diagnosis other than schizophrenia * a score of 3 on cdss question 8 which pertains to suicide

Keywords: acute, schizophrenia, phase2a, vabicaserin
online insomnia treatment program

Conditions: Insomnia; Sleep; Sleep Disturbance; Sleep Disorder; Sleep Hygiene; Sleep Initiation and Maintenance Disorders

Summary: the purpose of this study is to investigate improvements in sleep by comparing two 6-week digital programs, either online or app-based, that deliver cognitive behavioral therapy for insomnia (cbt-i), the "gold standard" treatment for insomnia, with or without a bedside device to help track sleep.

time needed from participant: 15 minutes per day to complete an app-based or online sleep diary and review information in an app-based or online cbt-i program. to qualify, you must: be 18+ years old have a diagnosis of insomnia or suspected insomnia have access to the internet and an iphone, android or other smart phone device coordinator contact: cris moreno (650) 721-7576 crismore@stanford.edu

Eligibility criteria:
inclusion criteria: * insomnia diagnosis or measure-confirmed moderate to severity insomnia (insomnia severity index = 15-28) * access to an iphone with ios 11+ or samsung, google, htc, lg, oneplus, or motorola phone with android 10+ * 18 years of age or older * available 15 mins per day to participate exclusion criteria: * restless legs syndrome * narcolepsy * sleep apnea * sleep walking * bipolar disorder * seizures disorder * substance abuse * frailty/risk of falling * severe memory problems * shift work * change in antidepressant medication within past 2 months * serious mental/physical health problem * other ongoing psychological treatment w * sleeping with pets. participants should be aware that should they receive a device, its sound and light alerts could be disruptive to partners or others (e.g., children) that sleep in the same room.
composite graft use in abdominal sacrocolpopexy reduces erosion rates

Conditions: Pelvic Organ Prolapse

Summary: this study is to determine whether the use of a composite biologic/synthetic graft during abdominal sacrocolpopexy leads to a lower rate of erosion while maintaining durability.

this study will examine the erosion rate of a composite graft that is being used during abdominal sacrocolpopexy. the composite graft is composed of a dual layer of biological and syntheric material. biological grafts have the advantage of significantly reducing erosion rates, but the longevity of biologic graft is uncertain. on the other hand, synthetic grafts have the advantage in that they are durable, but have higher erosion rates through the vagina and require re-operation in a small percentage of patients. this study will look at whether or not the use of a composite greaft carries the advantages of both types of materials and leads to decreased rates of erosion while maintaining longevity. the cost effectiveness of this new type of graft will also be reviewed since the disavantage of utilizing both the synthetic and biologic graft is that it will increase the cost.

Eligibility criteria:
inclusion criteria: * patients who underwent abdominal sacrocolpopexy with drs. noblett and lane from 2001 to present exclusion criteria: * none

Keywords: pelvic organ prolapse composite biologic/synthetic graft abdominal sacrocolpopexy
does the application of a bilateral-dual transverse abdominal plane (tap)block have an influence on lung function?

Conditions: Post Operative Pain

Summary: tap-block (transverse abdominal plane) block is a method of regional anesthesia used after abdominal surgery. the method is often applied ultra-sound guided. in our department, the so-called bilateral dual tap-block (bd-tap-block) has been developed. this includes injection of local anesthetics at four sites on the abdominal wall, aiming at the best possible spread of the nerve block. clinical experience shows satisfying results on pain relieve using the nerve block, i.e the sensory nerves of the abdominal wall are successfully blocked. however, to our knowledge, clinical investigations regarding the effect on the muscles of the abdominal wall has never been executed. patients with chronic lung diseases, who are prone to catch pneumonia post surgery, may have to be able to use accessory muscle groups to prevent pulmonary phlegm stagnation. therefore it would be inappropriate if the motor nerves supplying these muscles were too, affected by the nerve block. our clinical experience has so far not given us suspicion or indication that the motor nerves become blocked, although these nerves are situated in the same muscle layer as the sensory branches. hence the investigators would like to examine on healthy, male subjects, whether application of a bilateral-dual tap-block effects their ability to perform peak-flow and inspiratory and expiratory pressure. our study hypothesis is: there is no clinically relevant difference in the spread of results of pulmonary tests (peak flow et.c.) before and after application of bilateral dual tap-block.


Eligibility criteria:
inclusion criteria: * no history of asthma * young male * has to be able to conduct lung function examination and the application of abdominal nerve block exclusion criteria: * history of asthma

Keywords: pulmonary function bd-tap-block
15% topical resorcinol for hurley i-ii hidradenitis suppurativa.

Conditions: HYDRADENITIS

Summary: prospective, observational cross-sectional study to evaluate the response of patients with hs i-ii to monotherapy treatment of topical resorcin 15%, taking into account its safety, impact on quality of life and subclinical evolution.


Eligibility criteria:
inclusion criteria: * age \> 18 years. * diagnosed with hs hurley i-ii degree. * patients that have at least 1 or more swollen up nodules and/or abscess. * availability of affected region control ultrasound prior to resorcine treatment beginning. exclusion criteria: * age \< 18 years. * number of draining fistula above 20. * patients in active treatment with immunomodulators. * patients in active treatment with antibiotics.

Keywords: resorcinol hidradenitis suppurativa
a cost effective and time saving blood test to detect six human bloodborne infectious diseases

Conditions: HIV; Viral Hepatitis

Summary: the consortium will develop a new in vitro diagnostic (ivd) test to screen donated blood for bloodborne infectious pathogens, saving blood banks time and costs required for analysis of mandatory pathogens. the ivd test is a multiplex immunoassay that simultaneously screens for six bloodborne infectious diseases per blood sample. in this project, a mix of diagnostic protein markers will be developed and validated to lowdown an ivd test ready for commercial scale-up and ce-ivd certification.


Eligibility criteria:
inclusion criteria: - samples having been tested positive or negative for the serological markers explored in the study exclusion criteria: - to refuse to participate to the study

Keywords: serological assays
helius in hypertension-i: the uk hypertension registry

Conditions: Essential Hypertension

Summary: the purpose of this study is to demonstrate the use of a digital health offering in the management of persistent hypertension during chronic anti-hypertensive treatment.

in patients with persistent essential systolic hypertension,who are undergoing assessment of their current pharmaceutical burden for blood pressure control, a digital health offering is used (1) to provide automatic and passive electronic documentation of medication adherence and patterns of medication taking, (2) to assist providers in distinguishing inadequate medication adherence or pharmacologic unresponsiveness as the root cause for persistent hypertension, and (3) to inform management decisions (dose adjustment, medication addition or substitution, adherence counseling, referral to a hypertension specialist). participating patients wear an adhesive wearable sensor ("patch") continuously with replacement after one week, and ingest an inert tablet ("pill") containing an ingestible sensor daily whenever they take their prescribed anti-hypertensive drugs. the patch automatically detects and records the dates and times of each "pill" ingestion, daily step count, sleep duration and sleep interruptions, and the circadian pattern of rest and activity. after completion of each patch's use, the recorded data are downloaded and incorporated into a report that includes blood pressures that are obtained at the time of clinic visits at the beginning and after 2 weeks of service use. the final report is generated automatically and provided electronically to practitioners for review with their patient. the information that is obtained is incorporated by practitioners in advising next steps for blood pressure management.

Eligibility criteria:
inclusion criteria: * male or female of age ≥ 18 years * essential hypertension, consisting of: 1. blood pressure ≥150 or ≥90 during chronic treatment with 2 or more drugs for patients ≥80 years of age; or, 2. blood pressure ≥140 or≥90) during chronic treatment with 2 or more drugs for patients \<80 years of age * ability to read and understand the instructions for participating * capacity to read and to speak english proficiently * capacity to provide informed consent exclusion criteria: * history of skin sensitivity to adhesive medical tape or metals * history of acute or chronic dermatitis * any other condition that in the investigators opinion would compromise patient safety while participating * alcohol or other substance abuse * terminal illness
clinical and health economic impact of robot-assisted surgery vs conventional laparoscopy : the case of gastric bypass

Conditions: Morbid Obesity

Summary: the purpose of this study is to gather clinical and economic evidence on the use of robotics for bariatric surgery (gastric bypass). this monocentric, randomized, single blind, controlled study will evaluate post-operative pain, quality of life and appetite, post-operative complication incidence. it will also provide information on direct and indirect costs of surgery.

robot-assisted surgery versus conventional laparoscopy in bariatric surgery (gastric bypass): a prospective, single-blind, randomized, non-inferiority, and controlled study the main evaluation criterion is 24h post-operative pain assessed using visual analog scale (vas). secondary criteria included for clinical assessment: post 24h pain, excess weight loss, quality of life, appetite, complications, conversion rate; and for health-economics assessment : duration of surgical steps, length of stay, return to normal activity and their conversion to cost, consumables, estimation of indirect costs and benefits (e.g., robotics perception, publication). in this study, main inclusion criteria include major obesity (imc ≥ 35) with co-morbidities or morbid obesity (imc ≥ 40), scheduled gastric bypass surgery main contraindications are previous bariatric surgery and previous major abdominal surgeries to test robotic-assisted surgery non-inferiority on vas pain score 24h post-surgery, a total of 128 patients (64 per arm) is to be included (alpha 2,5%; power 90%; drop-out rate: 5%). the study will include 12 months of follow-up post-surgery for each patient. the total study duration is 2 years and 3 months.

Eligibility criteria:
inclusion criteria: * patient presenting with major obesity (bmi ≥ 35) with co-morbidities or morbid obesity (bmi ≥ 40)according to french has (haute autorité de santé) and cnamts (caisse nationale de l'assurance maladie des travailleurs salariés)criteria for whom gastric bypass is scheduled * male or female between 18 and 65 years old * patient registered with the french social security * patient having provided a written informed consent prior to enrolment * patient accepting to attend follow-up visits as required by study protocol exclusion criteria: * patient with a bmi ≥ 60 * patient with a contraindication for laparoscopic gastric bypass with or without robotic assistance * patient having had prior bariatric surgery * patient having had prior major abdominal surgery * patient in exclusion period of another clinical study * patient pregnant or breastfeeding * patient without sufficient knowledge of french language or unable to receive or understand study related information and answer to questionnaires * patient with no or limited legal capacity

Keywords: gastric bypass robot-assisted surgery conventional laparoscopy pain assessment health economics outcomes
incidence of neutropenic enterocolitis study in acute myeloid leukemia patients during intensive therapy

Conditions: Acute Myeloid Leukemia

Summary: neutropenia after induction or consolidation therapy for acute myeloid leukemia (aml) patients is associated with a high morbi-mortality rates, especially due to infectious complications. these are managed according to international recommandations (ecil and idsa) with antibiotherapy and antifungal strategy. although the patients suffer of digestive symptoms, intestinale complications are really less explored. neutropenic enterocolitis (ne), cytomegalovirus (cmv) colitis, clostridium difficile colitis, specific lesion, ischemic colitis are not well-known. no prospective study evaluate ne and these digestive complications which have high morbi-mortality rates.

this is the first prospective study on digestive affections in an homogeneous cohort of hematological patients. these affections are unknown in neutropenic patients with digestive symptoms after induction or consolidation courses pour aml although causing high morbi-mortality rates (infections, denutrition, loss of autonomy...). the aim of the study is to evaluate incidence of ne by clinical signs and with a systematic ct scan performed at day 5 of fever during aplastic period. an early diagnostic could decrease complications and evaluate gravity criteria which could imply surgery therapy. the physician will performe a ctscan with injection during the induction and/or every consolidation, at the same time as the thoracic ctscan (to research an invasive fungal bronchopulmonary infection), in front of a febrile neutropenia with persistent fever after 5 days of antibiotics and presence of digestive signs. the clinical, microbiological, radiological symptoms will be registered at every time of febrile neutropenia with digestive symptoms at induction and each consolidation courses. the patient will be get out of the study when the aml is refractory, hematopoietic stem cell transplantation is required or if whenever he want. the last visit will be at the end of consolidation courses.

Eligibility criteria:
inclusion criteria: * age \> 18 years * inclusion criteria: every patient of hematology: * able to receive an intensive treatment for aml (induction then intensive consolidations) causing a neutropenia with high infectious risk * in state to give its consent * affiliated to a social security system exclusion criteria: * the minor patients * the patients affected by aml not being able to receive an intensive therapy * the patients affected by acute promyelocytic leukaemia * the pregnant women * the patients with hiv, hepatitis b or c * the patients under guardianship or guardianship or deprived of freedom by a court or administrative order (according to articles l1121-6 and l1121-8 of the public health code)

Keywords: neutropenic enterocolitis acute myeloid leukemia abdominal tomodensitometry