Kornimate/medical-research-clean huggingface dataset:
study to evaluate nosocomial transmission of influenza

Conditions: Influenza

Summary: the purpose of this study is to investigate whether influenza can be reliably transmitted from children to susceptible contacts in a health care setting. the goal is to develop a transmission that can then be used to assess interventions to prevent transmission research objectives: to develop a model to investigate the frequency of influenza transmission from an infected child to a susceptible health care worker research hypotheses: influenza viruses can be transmitted from infected children to exposed health care workers

children with influenza infection presenting to ed will be identified by rat. healthy healthcare worker subjects will expose themselves and perform specific activities with the child. subjects will be followed by diary card, clinical symptom scores and virology swabs to assess frequency of transmission

Eligibility criteria:
inclusion criteria: * infected children * age \< 16 years * parents or legal guardians willing to give informed written consent * presenting with a febrile illness confirmed as influenza by near patient rapid antigen testing * healthy volunteers * willing to give informed written consent exclusion criteria * children * no parents or legal guardians able to give informed consent * healthy volunteers * known allergy to oseltamivir or zanamivir * presence of underlying condition or concomitant therapy requiring dose alteration of oseltamivir (severe renal or hepatic failure; methotrexate and probenecid) * underlying immunosuppressive disorder * known galactose intolerance * underlying chronic medical condition known to increase risk of influenza-related complications (including asthma, chronic pulmonary airways disease, chronic cardiovascular disease, diabetes mellitus, chronic neurological disorder) * inability or contraindication to collection of nasal swabs * previous influenza vaccination within 2 years * current smoker * pregnancy

Keywords: influenza, transmission
effects of high-intensity training compared to resistance training in cancer patients undergoing radiotherapy

Conditions: Prostate Cancer; Head and Neck Cancer; Rectum Cancer

Summary: the aim of this study is to assess the impact of a high-intensity aerobic training and resistance training on fatigue in prostate, head and neck and rectum cancer patients undergoing radiotherapy. a three-arm randomized controlled trial will be conducted. patients will be randomised into either a high-intensity aerobic training group or a resistance training group or a control group. participants in the training groups will exercised for five to eight weeks. exercise sessions will be take place 3 days per week under the supervision of an experienced therapist. subjects will be assessed at baseline and post-intervention. the primary outcome will be fatigue measured using the facit-fatigue questionnaire. the secondary outcomes will be: functional capacity, quality of life, executive functions, sleep disturbances, somnolence syndrome, insomnia, depression symptoms.


Eligibility criteria:
inclusion criteria : * a primary diagnosis of prostate cancer, head and neck cancer (oral cavity, pharynx, larynx, nasal cavity/sinuses, or salivary gland) or rectum cancer; * age over 18 years; * no distant metastases and/or disease progression; * at least 25 scheduled radiation treatments (5 weeks); * ability to read, write, and speak french. exclusion criteria : * uncontrolled cardiac, hypertensive or pulmonary diseases, * uncontrolled insulin-dependent diabetes mellitus, * neuropsychiatric disorders or orthopaedic conditions that would impair exercise participation * abnormal electrocardiogram.
acthar gel for active systemic lupus erythematosus (sle)

Conditions: Lupus Erythematosus, Systemic

Summary: this trial is to study acthar gel in participants with active systemic lupus erythematosus (sle). the doctor will assign eligible patients to one of two groups (like flipping a coin). participants will receive the treatment assigned to their group for 24 weeks: * acthar gel * placebo gel, which looks like acthar gel, but has no medicine in it. the doctor or his staff will take measurements and ask questions to: * see how well the gel is working * see how safe it is for patients with sle

this trial was initiated (started recruiting) in october 2016, but first patient was not enrolled (randomized) until december, 2016.

Eligibility criteria:
inclusion criteria: to be eligible to participate in this trial, a patient must: * have a diagnosis of sle according to 4 of the american college of rheumatology revised criteria * have active sle * have moderate to severe rash and/or arthritis as demonstrated by bilag-2004 score a or b in the mucocutaneous and/or musculoskeletal body systems at both screening and randomization visits * have a documented history or screening result of 1. positive antinuclear antibody (ana), or 2. elevated anti-dsdna or extractable nuclear antigen (ena) antibodies * have been on prednisone (or prednisone equivalent) before the screening visit: 1. at least 8 weeks, and 2. at a stable dose of 7.5 mg to 30 mg for at least 4 weeks exclusion criteria: a patient is not eligible to participate if he/she: * has a history of sensitivity to adrenocorticotropic hormone (acth) preparations or porcine products * has active lupus nephritis * has active central nervous system (cns) manifestations of sle
phase 2 study of ba058 (abaloparatide) transdermal delivery in postmenopausal women with osteoporosis

Conditions: Post Menopausal Osteoporosis

Summary: to determine the clinical safety and efficacy of abaloparatide transdermal in otherwise healthy postmenopausal women with osteoporosis as assessed by changes in bone mineral density (bmd) and serum markers of bone metabolism when compared to transdermal placebo and abaloparatide injection for 6 months of treatment.


Eligibility criteria:
inclusion criteria: * postmenopausal woman, less than 85 years old. * bmd t-score ≤-2.5 of spine or hip (femoral neck) or ≤-2.0 with previous fracture (within 5 years). * normal physical exam, vital signs, electrocardiogram (ecg), and medical history. * laboratory tests within the normal range, including serum calcium, vitamin d, parathyroid hormone (pth) (1-84), serum phosphorus, and alkaline phosphatase. exclusion criteria: * bmd t-score ≤-5.0 at the lumbar spine or hip. * history of bone disorders (for example, paget's disease) other than postmenopausal osteoporosis. * significantly impaired renal function. * history of any cancer.

Keywords: ba058 abaloparatide-sc abaloparatide abaloparatide-td osteo osteoporosis transdermal patch
turbohawk™ japan trial in patients with pad

Conditions: Peripheral Arterial Disease

Summary: the objective of this study is to evaluate the safety and effectiveness of the turbohawk for the treatment of peripheral arterial disease (pad) in the superficial femoral and/or the popliteal arteries with the japanese population.


Eligibility criteria:
inclusion criteria: * provides written informed consent * willing to comply with follow-up evaluations at specified times * has a rutherford clinical category score of 2-4 * disease located within the femoropopliteal artery * has evidence of ≥ 50% stenosis or occlusion in the superficial femoral and/or popliteal, confirmed by angiography * each discrete target lesion's length is ≥4cm and ≤ 15 cm * reference vessel diameter is ≥ 3.5 mm and ≤ 7.0 mm exclusion criteria: * previously implanted stent(s) or stent graft(s) in target leg * life expectancy less than 12 months * has any planned surgical or endovascular intervention of target vessel 30 days before or after index procedure * has in-stent restenosis of the target lesion * has an aneurysmal target vessel * has perforation, dissection or other injury of the access or target vessel requiring additional stenting or surgical intervention prior to enrollment
optimal inspiratory pressure for facemask pressure-controlled ventilation in children

Conditions: Child; Anesthesia

Summary: the purpose of this study is to find an optimal inspiratory pressure to provide adequate tidal volume and prevent gastric insufflation in pediatric patients. the children under 5 years old are randomly assigned to muscle relaxation group and non-relaxation group. for muscle relaxation group, routine anesthesia induction is performed with muscle relaxant and mask ventilation is started by pressure-controlled mechanical ventilation. gastric auscultation and abdominal ultrasonography are performed simultaneously during mask ventilation to detect inflow of air. initial inspiratory airway pressure is 10 cmh2o and increased gradually by 2 cmh2o until gastric insufflation is detected by either of two methods. tracheal intubation is done after detection of gas. for non-relaxation group, mask ventilation is performed in a same manner, without muscle relaxant. after detection of gas by any of the two methods, rocuronium 0.6 mg/kg is administered and tracheal intubation is performed.

the purpose of this study is to find an optimal inspiratory pressure to provide adequate tidal volume and prevent gastric insufflation in pediatric patients. the children under 5 years old are randomly assigned to muscle relaxation group and non-relaxation group. stratum was constructed based on age and randomization scheme was performed separately within each stratum. block randomization was done to ensure balance of the age groups. for muscle relaxation group, routine anesthesia induction is performed with muscle relaxant and mask ventilation is started by pressure-controlled mechanical ventilation. gastric auscultation and abdominal ultrasonography are performed simultaneously during mask ventilation to detect inflow of air. initial inspiratory airway pressure is 10 cmh2o and increased gradually by 2 cmh2o until gastric insufflation is detected by either of two methods. tracheal intubation is done after detection of gas. for non-relaxation group, mask ventilation is performed in a same manner, without muscle relaxant. after detection of gas by any of the two methods, rocuronium 0.6 mg/kg is administered and tracheal intubation is performed. tidal volume and oxygen saturation are recorded during study period.

Eligibility criteria:
inclusion criteria: * pediatric patients scheduled for elective surgery under general anesthesia * bmi \< 30 * asa class 1 or 2 exclusion criteria: * with difficult airway * preexisting pulmonary disease * upper respiratory tract infection * intestinal obstruction * with risk of pulmonary aspiration * history of stoke or moyamoya disease
a study of paravertebral block in thoracic outlet syndrome

Conditions: Thoracic Outlet Syndrome

Summary: this research is being done to evaluate the effects of receiving only a paravertebral block prior to first rib resection procedure versus receiving the block both pre and post procedure.


Eligibility criteria:
inclusion criteria: - all thoracic outlet syndrome patients scheduled for first rib resection surgery. exclusion criteria: * patients who are pregnant. * patients with prior first rib resection on side of presentation. * patients with complex regional pain syndrome (crps). * patients with brachial plexus disorder. * patients with cervical rib.

Keywords: first rib resection procedure
measurement of circulating mutation burden

Conditions: Breast Carcinoma; Genetic Predisposition to Cancer; BRCA Mutation; CfMB; Mutation Burden

Summary: cancer-free women with a hereditary predisposition to breast and/or ovarian cancer

this proof-of-concept trial will be conducted with family members being monitored for a predisposition to breast and/or ovarian cancer linked to a brca1/2 gene mutation. the study will be proposed to two sisters from the same sibling: * one is a carrier of the genetic mutation * and the other not, blood tests will evaluate the mutation burden cfmb

Eligibility criteria:
inclusion criteria: * female participant * participant undergoing oncogenetic follow-up at the centre françois baclesse * participant belonging to a pair of related biological siblings * within the sibling pair, one participant is a carrier of a hereditary predisposition linked to a brca1/2 mutation (case), and the other participant is not a carrier (control). * participant between 30 and 50 years of age * participant affiliated to a social security scheme * participant having given her consent to participate by signing an informed consent form prior to any specific study-related procedure. exclusion criteria: -

Keywords: cfmb predisposition to cancer brca1 brca2 breast cancer
gastric variceal ligation versus gastric variceal obturation for secondary prophylaxis of gastric varices

Conditions: Gastroesophageal Varices; Liver Cirrhosis

Summary: the investigators establish a randomized controlled clinical trial, comparing the efficacy and prognosis of gvl and gvo in secondary prevention of gvs, especially in patients with portosystemic shunting, and exploring the endoscopic treatment selection of different types of gvs. outcome expectations: compared with glue injection, endoscopic ligation for secondary prevention of gastric varices is safe and effective, especially in patients with portosystemic shunting.

gastric varices (gvs) is a common complication of portal hypertension, with an incidence of 20%. though the bleeding rate of gvs (25%) is lower than that of esophageal varices (evs), the mortality rate is higher due to greater gvs rupture and less space for endoscopic intervention. in addition, in 30% of patients with gvs, the possibility of treatment failure exists. guidelines differ on endoscopic treatment for secondary prevention of gvs.current studies suggest that evl, due to its low incidence of complications, is suitable for gov1, while it is still controversial for the treatment of gastric varices. compared with glue, the advantage of ligation is that it can avoid serious complications caused by glue injection, such as ectopic embolization, large ulcer and sepsis. as there are few studies comparing gvl and gvo in secondary prevention of gastric varices, the treatment methods are different, and the treatment effect is controversial. in addition, the choice of treatment for different types of gvs needs further study. the investigators establish a randomized controlled clinical trial, comparing the efficacy and prognosis of gvl and gvo in secondary prevention of gvs, especially in patients with portosystemic shunting, and exploring the endoscopic treatment selection of different types of gvs. outcome expectations: compared with glue injection, endoscopic ligation for secondary prevention of gastric varices is safe and effective, especially in patients with portosystemic shunting.

Eligibility criteria:
inclusion criteria: * patients over 18 years of age；past history of gastroesophageal variceal hemorrhage confirmed by an endoscopic examination exclusion criteria: * patients who are not suitable for endoscopic treatment judged by the clinician; patients who are not suitable for the ligation treatment because of scar change by repeated glue injection; patients with acute hemorrhage
search tolerance signature in vascularised composite allograft

Conditions: Hand and Face Allotransplantation

Summary: composite tissue allotransplants (cta) involve transplantation of various tissues including vessels, nerves, skin, bones, and immune cells and entail a significant antigenic load. the large majority of recipients have been maintained on immunosuppression therapy similar to that used in solid organ transplantation that is associated with the complications usually reported in solid organ transplantation. the question whether risks associated with indefinite immunosuppressive are justified for a non-lifesaving procedure still remains unanswered. at present no cta recipient proved to be spontaneously tolerant with any immunosuppressive protocol; indeed, until now all recipients who discontinued the immunosuppressive therapy rejected their graft. on the other hand cta recipients showed a low incidence of chronic rejection despite the high incidence of acute rejection episodes. for all these reasons it should be of great interest to minimize the immunosuppression in cta patients knowing their immunologic "risk". the main outcome of this study is to search for the signature of tolerance in recipients of hand or face allotransplantation testing biomarkers previously identified in operational tolerant kidney transplant recipients. these markers have been developed studying tolerant kidney recipients and they were already tested in five bilateral hand transplantations and one face transplantation. the present study will include hand and face allograft recipients transplanted at least one year in several european institutions (innsbruck, lyon, monza, valencia): 11 bilateral hand transplantations, 4 single hand transplantations and 3 face transplantations. all the patients will undergo b cell phenotyping, tcr repertoire, molecular signature from operational tolerance and a skin biopsy with immunohistochemical staining of the specimens in order to show signs of acute or chronic rejection. the results could provide a valid tool to detect operationally tolerant recipients as well as recipients prone to develop chronic rejection.


Eligibility criteria:
inclusion criteria: * patient with hand (unilateral/bilateral) or face allotransplantation for at least one year * patient without clinical sign of acute rejection at inclusion * patient who signed the informed protocol consent * patient older than 18 years old * patient covered by an health insurance * patient without legal protection exclusion criteria: * patient with hand or face allotransplantation for less than one year * patient with clinical sign of acute rejection at inclusion * unsigned protocol consent * patient under the age of 18 years old

Keywords: composite tissue allograft operational tolerance skin rejection hand and face allotransplantation
nociception level monitor (nol) during guided analgesic delivery in breast surgeries

Conditions: Anesthesia; Adverse Effect; Breast Cancer

Summary: to assess if perioperative consumption of opioids can be optimized with the assistance of a nociception level (nol) monitor in breast surgery patients receiving pectoral and parasternal nerve blocks as supplementation to general anaesthesia. hypothesis: 1. nol monitor guidance optimizes perioperative analgesic consumption and postoperative length of stay and offers a better quality of recovery in breast surgery. 2. intraoperative nol monitoring can detect the efficacy of pectoralis and parasternal nerve blocks. 3. incidence of persistent neuropathic pain after breast cancer surgery is lower in patients receiving lower doses of perioperative opioids.

optimal perioperative pain management is important not only for patient satisfaction but also for hemodynamic stability and effective restitution. despite being the principal element of anaesthesia, analgesia delivery has long been based on non-objective surrogate parameters such as blood pressure and heart rate. this may lead to hemodynamic inconsistency, poor restitution and patient dissatisfaction, which are some of the observed challenges. in that context, there has long been a search for a monitor which can guide the meticulous administration of analgesics. recently, a nociception level monitor (nol) based on an advanced software algorithm was developed using multiple physiological parameters. it offers an objective number (nol index) which relates to the level of intra-operative pain. nol technology has been validated and found superior to existing pain indicators in peer-reviewed publications. with the availability of nol monitors, a meticulous adjustment in the administration of opioids became a possibility. therefore, the investigators are planning a randomised study to investigate if opioid consumption can be reduced and if immediate and long-term postoperative complications can be minimised.

Eligibility criteria:
inclusion criteria: * american society of anaesthesiologists (asa) class i-iv patients scheduled for an elective mastectomy with or without axillary resection exclusion criteria: * inability to give consent, * atrial fibrillation, * local anesthetic allergy, * lumpectomy converted to mastectomy.

Keywords: nociception level monitor
the cellularity yield of three different 22-gauge fna needles

Conditions: Pancreatic or Peripancreatic Lesions; Lesions in the Esophagus, Stomach, Duodenum or Rectum; Mediastinal ( Chest) Masses; Enlarged Lymph Nodes

Summary: obtaining a sample from a lesion in the gastrointestinal tract by endoscopic ultrasound (a flexible tube with a camera and small ultrasound machine at its end )requires the use of a needle for taking the sample from the lesion or what we call "fine needle aspiration (fna)". currently, fna is done by three commercially available needles. these needles are used routinely in our institution for fna. the data regarding the safety and the successfulness of any of these needles are lacking. we sought to compare all three commercially available needles in a prospective manner.

the following are being done only for research purposes; prior to performing the fna, the patient will be randomized to one of the three commercially available fna needles. at this time, all needles are considered equivalent and there is no medical necessity to pick one over another. the sample obtained by the needle will be assigned a quality score based on certain parameters of the sample such as the abundance of diagnostic cells and the presence of blood. we are going to collect certain information about your procedure such as the complications of the procedure, number of needle passes and final diagnosis.

Eligibility criteria:
inclusion criteria: 1. adult patients (18-88) who are undergoing eus fna of pancreatic or peripancreatic lesions 2. adult patients (18-88) who are undergoing eus fna of submucosal masses in the esophagus, stomach, duodenum or rectum 3. adult patients (18-88) who are undergoing eus fna of mediastinal masses. 4. adult patients (18-88) who are undergoing eus fna of enlarged lymph nodes exclusion criteria: 1. patients younger than 18 yrs old or older than 88 yrs. 2. pregnant patients

Keywords: pancreatic adenocarcinoma lymphadenopathy endoscopic ultrasound