Kornimate/medical-research-clean huggingface dataset:
different surgical procedures of peroral endoscopic myotomy(poem) for esophageal achalasia

Conditions: Esophageal Achalasia; Esophageal Motility Disorders

Summary: this study compares the clinical efficacy of safety of circular myotomy and full-thickness myotomy guided by peroral endoscopic in treatment of incision length of ≤7cm and of ≥7cm in achalasia patients.

esophageal achalasia is an esophageal motor disorder, which is characterized by the absence of esophageal peristalsis combined with a defective relaxation of the lower esophageal sphincter (les). the major symptoms of esophageal achalasia are dysphagia, chest pain, and regurgitation of undigested food. currently, treatment options mainly focus on relief of the symptoms by reducing the les pressure. pneumatic dilation is the main endoscopic therapies for esophageal achalasia. however, the patients need repeat treatment to maintain therapeutic success and there is a risk of perforation (1%-3%). for surgery approaches, the laparoscopic heller's myotomy (lhm) combined with dor's antireflux procedure has gained considerable interest. the lhm can sustain therapeutic effects for long-term in approximately 80% of patients. recently, inoue et al. succeeded in treating achalasia endoscopically with a method called peroral endoscopic myotomy (poem) and achieved promising results in short-term. technically, poem derived from natural orifice transluminal endoscopic surgery (notes) and endoscopic submucosal dissection (esd), in which a submucosal tunnel is created after submucosal injection, and then an endoscopic myotomy was made at the gastroesophageal junction. however, the clinical efficacy of safety of circular myotomy and full-thickness myotomy guided by peroral endoscopic in treatment of incision length of ≤7cm and of ≥7cm in achalasia patients were not determined, and there was no prospective study that compared different surgical procedures of poem for esophageal achalasia. therefore, we aim to compare the clinical efficacy of safety of circular myotomy and full-thickness myotomy guided by peroral endoscopic in treatment of incision length of ≤7cm and of ≥7cm in achalasia patients.

Eligibility criteria:
inclusion criteria: 1. between 18 and 75 years of age; 2. patient with esophageal achalasia; 3. eckardt score \> 3; 4. signed informed consent. exclusion criteria: 1. severe cardio-pulmonary disease or other serious disease leading to unacceptable surgical risk; 2. pseudo-achalasia, mega-oesophagus (greater than 7 cm), or oesophageal diverticula in the distal oesophagus; 3. previous endoscopic botox injection; 4. previous oesophageal or gastric surgery; 5. pregnancy or lactation women, or ready to pregnant women; 6. not capable of filling out questionnaires.

Keywords: esophageal achalasia peroral endoscopic myotomy poem
evaluation of tibial nerve selective neurotomy compared to botulinum toxin injections for spastic foot treatment in post-stroke patients according to a goal-centered approach

Conditions: Post Stroke Seizure; Spastic Foot

Summary: in france, more than 110.000 patients are hospitalized for stroke per year. it is the leading cause of sudden disabilities in adults. incidence of spastic foot is evaluated at 1 year post stroke from 18% to 56% of hemiplegic patients. spasticity, defined as an increase in the velocity-dependent response to muscle stretch measured at rest, is part of the upper motor neuron syndrome and is characterized by an increase in tonic stretch reflex. it has been proposed that upper motor neuro syndrome may induce not only spasticity but also other types of muscles overactivity such as spastic dystonia, co-contraction and clonus. in hemiplegic patients, lower limb spasticity within the posterior part of the leg frequently results in equino-varus foot and toes claw. these abnormal postures in hemiplegics may affect activities of daily living such as shoes fitting, balance, ambulation-walking, comfort (pain) and may become irreducible (tendon shortening) if not treated. the purpose of this study is to compare the interest of each treatment (bont-a versus stn) in order to specify both techniques indications and up-date current guidelines of lower-limb spasticity for hemiplegic patients. this study aims to confirm a greater reduction of calf muscles spasticity after stn as compared to bont-a, as observed in the only published monocentric randomized controlled trial. our study originality is to perform a multi-center rct with a pre-established sample size. this study will also quantify progress towards personal goals using the goal attainment scaling (gas) and will assess other components related to the consequences of carve muscle spasticity on balance, ambulation, self-care and quality of life.


Eligibility criteria:
inclusion criteria: * adult patients (older than 18 years) * man and woman * hemiparesis secondary to stroke (delay from stroke \> 1 year) * foot with equinovarus with or without toe claw due to spasticity of at least the triceps surae and /or one of the following muscles: tibialis posterior, flexor digitorum and hallucis longus muscles. * spasticity confirmed with no isolated tendon shortening diagnosed using tibialis nerve block under local anesthesia with at least a 5 degrees gain in passive or active ankle dorsal flexion. * covered by national french insurance * able to understand french and the purpose of the study * informed consent signed by the patient or consent obtained from a relative or trusted person of the patient exclusion criteria: * known sensitivity to bont or botulinum toxin a excipients * contraindication to surgery under general anesthesia * history of myasthenia * pregnant woman (confirmed by urinary test) or breastfeeding * patient under legal protection * patients unable to follow the requirement of the study according to the investigator or supported by a family member

Keywords: tibial nerve selective neurotomy botulinum toxin spastic foot post-stroke patient
the effects of individualized oxygen dynamic on prognosis of patients with high-risk cardiac surgery

Conditions: Cardiac Disease; High Risk Sex

Summary: anesthesia-related factors have been linked to poor perioperative outcomes. our observational study suggested that the cumulative duration of a triple-low state \[intraoperative low mean arterial pressure (map), low bispectral index (bis), and low target effect-site concentration(ce) \]was associated with poorer 30-day mortality.this randomized, prospective study based on individualized oxygen dynamics is designed to confirm this association in high-risk patients cardiopulmonary bypass (cpb).


Eligibility criteria:
inclusion criteria: 1. written informed consent; 2. selective cardiac surgery and general anesthesia patients; 3. age 18-90 yrs; 4. anesthesia society of american (asa) scale ii-iv 5. european system for cardiac operative risk evaluation score equal to or greater than 6 or left ventricular ejection fraction lower than 50% exclusion criteria: 1. preoperative cardiac ejection fraction\<30 %; 2. history of anesthesia awareness; 3. history or anticipation of difficult intubation; 4. unanticipated intraoperative conditions, including haemorrhage, obstinate resuscitation failure,multiple cardiopulmonary bypass procedures, severe hypotension or hypoxemia; 5. long-term preoperative use of anticonvulsant agents, opiates, benzodiazepines or cocaine.

Keywords: oxygen dynamics prognosis
a pk and safety study in subjects with hepatic impairment

Conditions: Hepatic Impairment

Summary: assess the single dose pk and safety of tr701 fa in subjects with moderate or severe hepatic impairment versus matched control subjects with normal hepatic function.

this study will assess the single-dose pharmacokinetics (pk) and safety of tr-701 free acid (fa) in subjects with moderate or severe hepatic impairment compared with matched control subjects with normal hepatic function.

Eligibility criteria:
inclusion criteria: * moderate or severe hepatic impairment or matched control * bmi between 18.0 and 40.0 kg/m2 exclusion criteria: * evidence of acute deterioration of hepatic function within 8 weeks * alt or ast ≥ 5 times upper limit of normal for moderates; alt or ast ≥ 8 times upper limit of normal for severes * total bilirubin \> 5 mg/dl for moderates; no upper limit for severes * hemoglobin \< 10g/dl for moderates; hemoglobin \< 9g/dl for severes

Keywords: hepatic impairment matched control subjects
efficiency of early intervention for autism spectrum disorder

Conditions: Autism Spectrum Disorder

Summary: intervention for autism spectrum disorder (asd) in european french-speaking countries is often heterogeneous and poorly evaluated. six french-speaking early intervention units for children with asd following the early start denver model (esdm) have been created since 2011 with the common aim to evaluate effectiveness and cost-efficiency of the esdm applied to the european french-speaking public health system. in those units, children receive esdm at minimum 12h per week by trained therapist. therapist work in collaboration with parents (at home) and preschool or nursery. the first aim of the investigators study is to evaluate the effectiveness of esdm intervention 12 hours per week during 2 years on the global development of children with asd compared to the interventions commonly available in the community.

this is a multicenter (4 centers in france, 1 center in switzerland and 1 center in belgium), randomized, controlled, single blind trial using a modified zelen design .it concerns children with asd aged 18 to 36 months without severe neurological or physical disorder and living in the proximity of one the early intervention units. after diagnostic, children will be included in a longitudinal cohort with the consent of the parents. sixty children will be drawn lots among 180 children of the cohort and will be included in a esdm intervention with the consent of the parents. two groups will be compared: an experimental group of 60 children receiving 12 hours a week of esdm intervention delivered by trained therapists during 2 years and a control group of 120 children receiving typical heterogeneous 'as-usual' intervention proposed by professionals and public services over the same period. global developmental profiles of all the children will be measured at different time points over the two years through standardized tests such as the mullen scale of early learning (msel), the ados-2 and the vineland adaptive behavior scale. cost of each intervention will be calculated. the primary outcome is global development of the child, measured by the developmental quotient with the mullen after 24 months of intervention.

Eligibility criteria:
inclusion criteria: * children 15 months to 36 months * children with autism spectrum disorder (according to international criteria and standardized tests) * children at a dq of 30 at least at the msel * family domiciled within 40 minutes of a early intervention unit (investigator center for the study) exclusion criteria: * severe neurological or physical disorder identified not allowing intensive care * unavailability of the family for regular monitoring of the child by the investigator center * rett syndrom

Keywords: early intervention esdm behavioral and developmental intervention
a french protocol for the treatment of acute lymphoblastic leukemia (all) in children and adolescents

Conditions: Acute Lymphoblastic Leukemia

Summary: a still major question in the field of acute lymphoblastic leukemia (all) in children - an extremely heterogeneous disease though curable in 80-90% of children and 70-80% of the adolescents - is the optimal use of l-asparaginase (asnase). it is known that administering asnase results in the depletion of asparagine circulating in the blood, which starves the leukemic cells and results in their death. but indeed the use of asnase varies between protocols considering the different brands, the dose and the administration modalities. oncaspar (pegylated e. coli asparaginase, pegaspargase) was thus developed with the goal of reducing the immunogenicity of the native asnase. this is a french prospective multicentric cohort study of children and adolescents with all, stratified on (i) the type of all ( b vs t) and (ii) the anticipated risk (stratified in 3 groups for childhood b-cell precursor (bcp)-all and 2 groups for t-cell all). it aims to answer to two different issues: 1. randomized question: what is the best way to administer pegaspargase? a cohort of children and adolescents with standard or medium risk all will be randomized to receive during induction either one infusion of oncaspar® 2500 iu/m2 at d12 or two infusions of oncaspar® at 1250 iu/m2 each at d12 and d26. patients will then receive 2500 iu/m2 or 1250 iu/m2 per dose during consolidation and delayed intensification according to the initial arm of randomization. 2. non randomized question: in the high/very high risk groups, a non randomized intensification of the scheme of asparaginase administration is proposed during induction therapy: 2 infusions of 2500 iu/m2/day (d12 and d26) will be administered. all patients will receive 2500 iu/m2 per dose during consolidation and delayed intensifications.


Eligibility criteria:
inclusion criteria: * all l1 or l2 * b-lineage or t- lineage all exclusion criteria: * l3 (burkitt's leukemia) * mixed phenotype acute leukemia (who criteria). * infant all (age ≤ 365 days) * philadelphia (ph)+/breakpoint cluster region (bcr)-abelson (abl) all
the effect of two aspirin dosing strategies for obese women at high risk for preeclampsia

Conditions: Preeclampsia

Summary: low dose aspirin (lda) is used for preeclampsia (pe) prevention in high risk women, but the precise mechanism and optimal dose is not known. evidence in the non-obstetric literature suggests ar may be more common among patients with a high body mass index (bmi). recent unpublished data showed that lda substantially lowers txb2 levels regardless of bmi, but rates of complete platelet inhibition are lower in women with bmi ≥40. this data suggests that higher doses of asa may be necessary in obese women. therefore we plan determine if use of 162mg compared to the traditional 81mg asa decreased rates of preeclampsia in women considered high risk for developing preclampsia.

evidence suggests that an imbalance in prostacyclin and thromboxane a2 (txa2) plays a key role in pe. aspirin (asa) has a dose-dependent effect blocking production of txa2, a potent stimulator of platelet aggregation (pa) and promoter of vasoconstriction. incomplete inhibition of pa, designated aspirin resistance (ar), can be reduced by increasing the asa dose.

Eligibility criteria:
inclusion criteria: * bmi at enrollment \>/= 30 * plan for asa for preeclampsia prevention exclusion criteria: * bmi \< 30 * already on asa

Keywords: aspirin obesity
assessment of the antiviral effect of atorvastatin on hepatitis c virus

Conditions: Hepatitis C

Summary: we hypothesize that atorvastatin will decrease hcv viral load in patients taking the medication. cholesterol is needed for hcv virion production. cell culture studies have shown that atorvastatin (an hmg-coa reductase inhibitor) decreases hcv viral replication. as atorvastatin has been proven to decrease heart attack and stroke in patients with high cholesterol, this medication is indicated for the treatment of elevated cholesterol in at risk individuals. therefore we propose to study the effect atorvastatin has on the viral load of patients initiated on atorvastatin therapy for their elevated cholesterol.

men and women ages 30 to 80 infected with hcv viremia whose physician has determined need cholesterol lowering medication will be recruited by the study investigators from massachusetts general hospital. the study investigators will approach the potential subject after the referring doctor has ascertained that the potential subject is interested in meeting with the investigator. each subject who consents will undergo phlebotomy of 10 cc of blood three times. once prior to the initiation of atorvastatin to measure the patients viral load. in addition, patients will undergo phlebotomy 4 and 12 weeks after the initiation of atorvastatin. the week 12 phlebotomy is required in all patients started on atorvastatin to monitor for side effects. therefore patients who enroll in this study will undergo one additional phlebotomy. as part of our study an extra 10 cc of blood will be taken at these times to measure the patients hcv viral load.

Eligibility criteria:
inclusion criteria: * patients with chronic hcv. * patients who need treatment for their elevated cholesterol: * total cholesterol \>240 or * ldl \>160 without cardiac risk factors or * ldl \>130 with two cardiac risk factors (hypertension, smoker, family history of heart attach, or hdl \<40 for men or \<50 for women) or * ldl \>100 with diabetes or known coronary artery disease exclusion criteria: * impaired mental ability preventing a subject from understanding the protocol or from completing the entire study. * hcc * a history of an adverse reaction to any hmg coa reductase inhibitor. * patients who are on hcv treatment, who plan to initiate hcv treatment within 3 months, or who discontinued hcv treatment within the last 3 months. * patients whose aminotransferases are \> 5 times the upper limit of normal.

Keywords: hepatitis c viral load antiviral therapy cholesterol atorvastatin
phenotype assessment of blood and airway eosinophils in patients with copd and asthma

Conditions: COPD Asthma; Eosinophilic Asthma

Summary: around 1/3 of patients with copd have elevated eosinophil levels. however, the role of eosinophils in copd has not been yet understood and is probably different in copd and in asthma. the aim of this study was to assess the expression of selected surface markers on eosinophils and to assess the gene expression in eosinophils in copd and asthma patients. we are planning to enrol 12 copd, 12 asthma and 12 control subjects. patients will undergo routine clinical assessment, spirometry, blood sampling and sputum induction. eosinophils will be isolated from blood and sputum. surface markers on eosinophils will be assessed in flow cytometry, gene expression will be assessed by rnaseq.


Eligibility criteria:
inclusion criteria: * diagnosis of copd according to gold 2019 or asthma according to gina 2021 * peripheral blood eosinophil count ≥ 100 / μl * age ≥40 years (copd), ≥18 years (asthma) * history of cigarette smoking: ≥10 pack-years (for copd) * stable disease period (at least 3 months without exacerbation) * exclusion of parasitic diseases * informed consent to participate in the study exclusion criteria: * copd and asthma overlap * use of systemic corticosteroids in the 3 months prior to the study * respiratory infection or exacerbation in the 3 months prior to the study * acute and chronic respiratory failure * concomitant diagnoses: systemic connective tissue diseases, malignant neoplasms, severe and / or uncontrolled cardiovascular diseases * use of immunosuppressive or immunomodulating drugs in the 3 months preceding the study * contraindications to sputum induction * no consent to participate in the study

Keywords: eosinophil copd asthma
the use of resting state, fmri and dti in the identification of chronic pain conditions

Conditions: Chronic Pain

Summary: resting state fmri scans of chronic pain sufferers will be compared to those of healthy normals and may be sufficiently different to allow a high level of classification accuracy of whether subjects have chronic pain. in addition, investigators will utilize dti and a brief activation state using pain rumination to assess whether investigators can reliably find differences between chronic pain sufferers and healthy normals.

resting state fmri scans of chronic pain sufferers may be sufficiently different from scans of normal subjects to allow a high level of classification accuracy of whether subjects have chronic pain. in addition, investigators will utilize dti and a brief activation state using pain rumination to assess whether investigators can reliably find differences between chronic pain sufferers and healthy normals. the analysis will use pattern recognition methods in a leave n out cross validation design. the success of the classifications will be the mean of all the validation runs.

Eligibility criteria:
inclusion criteria: daily pain lasting for more than 6 months. ages eligible for study are between 20 and 70 years. exclusion criteria: adults unable to consent children, teenagers pregnant women prisoners subjects who do not know english mri exclusion criteria

Keywords: chronic pain fmri dti
frailty study of older adults getting chemotherapy and radiation therapy

Conditions: Cancer

Summary: the investigators hypothesize that frailty assessment prior to concurrent chemotherapy and radiation therapy in the elderly will predict treatment-related toxicity and morbidity and that such assessment at serial time points will help improve treatment and outcomes for these patients.


Eligibility criteria:
inclusion criteria: * patients must have one of the following histologically or cytologically confirmed cancers: lung cancer, head and neck cancer, gastric cancer, anal cancer, rectal cancer, cervix cancer, or bladder cancer, and must have appropriate indications for the use of standard concurrent chemotherapy plus radiation therapy as defined in the nccn (national comprehensive cancer network) guidelines for each of these specific organ-sites. * age \>70 years. * ecog (easter cooperative oncology group) performance status of 0, 1 or 2. * life expectancy tables showing upper, middle, and lower quartiles of life expectancy for women and men age 70 and older should be used and life expectancy should be estimated to be of sufficient to justify the use of concurrent chemotherapy plus radiation for each organ site and indication. * ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered to baseline from adverse events due to agents administered more than 4 weeks earlier. * patients who are receiving any investigational agents. * patients with known distant site metastases (m1 disease) or brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * patients who have a history of one or more other concurrent cancers besides the cancer for which concurrent chemotherapy plus radiation therapy is considered are ineligible only if the other cancer or cancers are being considered for treatment or are actively being treated. * patients carrying a pre-existing diagnosis of hiv/aids and are on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with chemotherapy. in addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated. * patients with any standard contraindication to chemotherapy or radiation therapy are ineligible. * transplant recipient patients on immune-suppressant agents are ineligible due to increased risk of infection.

Keywords: frailty geriatric oncology