Kornimate/medical-research-clean huggingface dataset:
preoperative chemo-radiation with ig-imrt dose escalation for locally advanced rectal cancers

Conditions: Advanced Rectal Cancers

Summary: hypothesis : therapeutic intensification by increasing the dose delivered to the tumor by rcmi (conformational radiotherapy by intensity modulation) in order to reduce local relapse, often associated with poor prognosis primary objective: evaluate the rate of tumor sterilization and the toxicities of rtct with concomitant boost in intensity modulation in patients with rectal cancer ct3-t4 and / or cn1-2.


Eligibility criteria:
inclusion criteria: 1. adenocarcinoma of the rectum ct3 or ct4 or cn+, m0 and for which cpr recommends preoperative radiochemotherapy 2. tumor \<15 cm of the anal margin in rigid or subperitoneal rectoscopy at the mri 3. tumor potentially resectable from the outset, or considered to be resectable after radiochemotherapy 4. operable patient 5. age between 18 and 75 6. oms performance status 0-2 7. no co-morbidity likely to prevent the delivery of treatment 8. adequate contraception for men, and for non-menopausal women 9. neurotrophic neutrophils 1500 / mm3, platelets 100 000 / mm3, and hemoglobin 10 g / dl 10. bilirubin ≤ 1.5 times the upper limit of normal (lns), asat and alat ≤ 1.5lns, alkaline phosphatase ≤ 1.5 lns 11. creatinine clearance\> 50 ml / min 12. patient must have been informed and must have signed the specific informed consent form. 13. patient must be affiliated to a social health insurance. exclusion criteria: 1. remote metastasis 2. cancer not resectable 3. contraindication to capecitabine and its excipients 4. previous history of pelvic radiotherapy or previous chemotherapy 5. history of inflammatory bowel or rectum disease 6. history of angina pectoris monitored or myocardial infarction or heart failure 7. active active infection or other serious underlying condition that may prevent the patient from receiving treatment 8. other concomitant cancer, or history of cancer other than in situ cancer of the treated cervix or basal cell carcinoma or squamous cell carcinoma 9. patient already included in another therapeutic trial with an experimental molecule 10. pregnant woman, likely to be pregnant or nursing 11. persons deprived of their liberty or under guardianship 12. patient unable to comply with the required medical follow-up for geographic, social or psychological reasons

Keywords: dose escalation, chemo-radiation, rectum cancer, phase 2
proton and heavy ion beam radiation vs. photon beam radiation for newly diagnosed glioblastoma.

Conditions: Glioblastoma

Summary: this is a multi-center prospective phase 3 clinical trial to explore the efficacy and side effects of standard-dose photon radiation versus standard-dose proton radiation versus carbon ion boost plus standard proton radiation for newly diagnosed glioblastoma. the patients enrolled will be randomly allocated with 1:1:1 to three group: control group, standard-dose photon radiotherapy; study group a, standard-dose proton radiotherapy; study group b, standard-dose proton radiotherapy plus induction carbon-ion radiotherapy boost. the primary endpoint is overall survival (os).

this multi-center prospective phase 3 clinical trial will enroll 369 patients with newly diagnosed glioblastoma. patients will be randomly allocated with 1:1:1 to three groups: control group, standard-dose photon radiotherapy (60 gy); study group a, standard-dose proton radiotherapy (60 gye); study group b, standard-dose proton radiotherapy (60 gye) plus induction carbon-ion radiotherapy boost (15gye/3f). all patients will receive concurrent and adjuvant temozolomide according to the stupp protocol. the primary endpoint is overall survival (os). the secondary endpoint is progression-free survival, side effect and quality life.

Eligibility criteria:
inclusion criteria: * age\> 18 years old and \<80 years old * pathologically confirmed newly-diagnosed gbm * redisual lesion after subtotal resection, partial resection, or biopsy * no dissemination or metastasis in the spinal canal, single lesion, supratentorial lesion * ecog score 0-1 * sign the informed consent form before starting the research exclusion criteria: * no pathological confirmed evidence of gbm * multiple lesions or distant spread indicated by imaging studies * receive conventional photon/proton/carbon ion radiation therapy on the head * received intracranial radioactive particle implantation * a history of malignant tumors or multiple primary tumors (except skin basal cell carcinoma) * positive pregnancy test for women of childbearing age * with the accompanying diseases or conditions affect the safety of patients during normal enrollment or research * active mental disorders or other mental disorders that affect the patients ability to sign informed consent and understand * uncontrolled active infection

Keywords: glioblastoma carbon-ion radiotherapy proton radiotherapy photon radiotherapy overall survival
a phase 1 study to characterize the effect of gs-5737 enhancement of mucociliary clearance (mcc) in healthy subjects

Conditions: Cystic Fibrosis; Chronic Obstructive Pulmonary Disease

Summary: this is a randomized, double-blind, cross-over, vehicle-controlled study to determine whether gs-5737 in 2.8% saline accelerates mucociliary clearance (mcc) in healthy subjects, compared to vehicle of 2.8% saline alone.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) from ≥ 19 to ≤ 30 kg/m2 * normal ecg, with no history or evidence of myocardial infarction, qt prolongation, or ventricular arrhythmias * normal (or abnormal but not clinically significant) blood pressure (bp) and heart rate(hr) * history of lifetime smoking \< 5 pack-years (ie, 1 pack per day x 1 year = 1 pack-year)and non-smokers of at least 60 days duration prior to screening * negative screening tests for drugs of abuse (including alcohol) * hepatitis b (hbv) surface antigen negative * hepatitis c (hcv) antibody negative * hiv-1, 2 antibody negative * male subjects who are sexually active must be willing to use highly effective contraception from the baseline visit through completion of the study and continuing for at least 90 days from the date of the last dose of study drug * male subjects must refrain from sperm donation from the baseline visit through completion of the study and continuing for at least 90 days from the date of the last dose of study drug * females of childbearing potential must have a negative serum pregnancy test * females of childbearing potential must agree to utilize protocol recommended highly effective contraception methods from screening throughout the duration of study treatment and for 30 days following the last dose of study drug exclusion criteria: * female subjects who are pregnant or lactating * history of anaphylactic reaction to any drug * have previously participated in an investigational trial involving administration of any investigational compound within 30 days prior to the study drug dosing * presence or history of extrinsic allergy requiring treatment; hay fever is allowed unless it is active or has required treatment within the previous 2 months * have donated blood within 56 days of study dosing * presence or history of any pulmonary diseases (ie, asthma, emphysema, chronic bronchitis, chronic obstructive pulmonary disease (copd), cystic fibrosis (cf), bronchiectasis, interstitial lung disease) * major surgery within 6 months of screening * experienced symptoms of recent acute upper or lower respiratory tract infection requiring treatment within the 2 weeks prior to screening * have had any radiation in the past year that would cause the subject exceed recommended limits by participating in this study protocol

Keywords: respiratory health cystic fibrosis chronic obstructive pulmonary disease
clinical trial of minimally invasive robotic spine surgery

Conditions: Degenerative Lumbar Spinal Stenosis

Summary: the purpose of this study was to quantify potential short- and long-term benefits of robotically-guided minimally invasive spine surgery in instrumentation of degenerative lumbar or lumbosacral spine disease in adult patients, in comparison to instrumentation in a matching cohort of control patients performed using conventional freehand technique.


Eligibility criteria:
inclusion criteria: * adult patients (age from 40 years to 85 years), undergoing short (below 3 consecutive vertebrae) lumbar or lumbosacral fixation surgery. * primary surgery and revision surgery * patient capable of complying with study requirements * signed informed consent of patient or legal guardian exclusion criteria: * infection or malignancy * primary abnormalities of bones (e.g. osteogenesis imperfecta) * primary muscle diseases, such as muscular dystrophy * neurologic diseases (e.g. charcot-marie tooth, guillain-barre syndrome, cerebral palsy, neurofibroma) * spinal cord abnormalities with any neurologic symptoms or signs * spinal cord lesions requiring neurosurgical interventions, such as hydromyelia * paraplegia * patients requiring anterior release or instrumentation * any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study. * patient cannot follow study protocol, for any reason * patient (or legal guardian, when applicable) cannot or will not sign informed consent
an open-label, multicenter, phase 2 study to evaluate the efficacy and safety of eribulin mesylate in previously treated subjects with advanced or metastatic soft tissue sarcoma (study e7389-j081-217)

Conditions: Soft Tissue Sarcoma

Summary: the purpose of the study is to evaluate the efficacy and safety of eribulin mesylate in subjects with soft tissue sarcoma who received at least one standard chemotherapy (an anthracycline or an ifosfamide monotherapy or a combination therapy).


Eligibility criteria:
inclusion criteria * histologically or cytologically confirmed soft tissue sarcoma of high or intermediate grade * documented evidence of advanced or metastatic soft tissue sarcoma, not amenable to surgery or radiotherapy * within 6 months from the radiographic evidence of disease progression by recist criteria in the last chemotherapy regimen for advanced or metastatic soft tissue sarcoma * presence of measurable disease by response evaluation criteria in solid tumors (recist) 1.1 * subjects who received at least one standard chemotherapy for advanced soft tissue sarcoma (an anthracycline or an ifosfamide monotherapy, or a combination therapy) * subjects aged ≥ 20 years at the time of informed consent * eastern cooperative oncology group (ecog) performance status (ps) of 0 or 1 * adequate organ function * voluntary agreement to provide written informed consent exclusion criteria * a history of malignancies or recurrence within 5 years after the remission * significant cardiovascular impairment * any serious concomitant illness or infection requiring treatment. * hypersensitivity to either halichondrin b or halichondrin b chemical derivatives or both. * subjects who have previously participated in a study with eribulin (whether treated with eribulin or not). * any medical or other condition which, in the opinion of the principal investigator, will preclude participation in a clinical trial. * subjects who have received any anti-cancer therapy, including surgery, radiotherapy, immunotherapy, cytotoxic, hormonal, biological (including humanized antibodies) and targeted agents within 21 days, or any investigational agent within 30 days, prior to the first dose of study drug. * subjects who have not recovered from toxicities as a result of prior anti-cancer therapy to ≤ grade 1, according to common terminology criteria for adverse events (ctcae), except for peripheral neuropathy of grade 2 and alopecia. * subjects with known cerebral metastases with clinical symptoms or requiring treatment. * pre-existing peripheral neuropathy \> ctcae grade 2. * female subjects must not be pregnant with a negative by the pregnancy test at screening, or breastfeeding. * subjects participating in other clinical trials

Keywords: soft tissue sarcoma
prehabilitation and rehabilitation for patients with oesophageal cancer

Conditions: Esophageal Cancer

Summary: patients with oesophageal cancer selected for oncological and surgical treatment with curative intent are offered supervised physiotherapy and home-based training before and after surgery.

patients with loco-regional oesophageal cancer who will receive neoadjuvant chemotherapy or chemoradiotherapy followed by surgery and sometimes adjuvant chemotherapy are eligible to be enrolled in the trial. study treatment is supervised group training twice weekly and home-based training three times weekly during neoadjuvant treatment and after surgery.

Eligibility criteria:
inclusion criteria: * histopathologically confirmed squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma in the oesophagus or cardia (siewert i or ii), ct1 n+ or ct2-4a any n, m0, according to the 8th version of the ajcc tnm classification. * assessed at a multidisciplinary conference to be suitable for curatively intended oncological and surgical treatment. * age \> 18 years. * performance status ecog 0-2. * patient has provided written informed consent. exclusion criteria: * previous radiotherapy in the thorax (except for tangential field radiotherapy for breast cancer). * inability to understand written and spoken instructions and to comply with protocol requirements.
evaluating pvi using cmr

Conditions: Atrial Fibrillation

Summary: using state of the art cardiac magnetic resonance imaging techniques, characterization of ablation lesions in the early phase after pulmonary vein isolation ablation in atrial fibrillation patients, and relate findings to the ablation scar at 3 months follow up and atrial fibrillation-free survival at 1 year.


Eligibility criteria:
inclusion criteria: * adult patients (age ≥18 years old) * paroxysmal or persistent af meeting guideline criteria. * anticipated pvi using index-guided radiofrequency ablation techniques. * availability of lge-cmr images within 3 months before anticipated pvi. exclusion criteria: * history of catheter ablation * history of cardiac surgery. * history of chest radiation therapy * estimated glomerular filtration rate (egfr) \<45 ml/min/kg * known (or suspected) allergic reaction to gadolinium * contraindications for cmr (such as claustrophobia, certain implants, devices, high body mass index). * inability to schedule cmr \<48h after pvi * long-term use of anti-inflammatory medication, except for the use of nonsteroidal anti-inflammatory drugs * autoimmune disease or chronic inflammatory illness. * pregnancy of breast feeding
cav regimen bridging to hsct for r/r al

Conditions: Acute Leukemia, Relapsed; Acute Leukemia Refractory

Summary: although allogeneic hematopoietic stem cell transplantation (hsct) is a curative treatment option for acute leukemia (al), relapsed or refractory (r/r) al is still a big challenge. it is believed that decreased tumor burden before hsct is a favorable factor contributing to the long-term survival of r/r al patients and many kinds of bridging chemotherapy regimens were devised to kill leukemic cells before hsct, there is still no consensus that which regimen is optimal. this study is to investigate the curative efficacy and safety of bridging cav (cladribine combined with low dose ara-c and venetoclax) regimens followed by hsct treatment protocol for r/r aml.


Eligibility criteria:
inclusion criteria: 1. patients with al must meet one of the following criteria ：a or b. a: relapsed al disease was defined as follows: (1) reappearance of leukemic blasts in the peripheral blood after cr; or (2) detection of \>5% blasts in the bone marrow (bm) not attributable to another cause(e.g. regeneration after consolidation therapy); or (3) extramedullary relapse. b: refractory al disease was defined as follows: (1) failure to achieve cr, crh or cri after two courses of intensive induction treatment. or (2) failure to achieve complete remission after one cycle of induction chemotherapy or a reduction in the number of blasts of less than 50% after one cycle of induction treatment, with residual blasts \>15%. 2. patients without ≥grade 3 of cardiac, hepatic, pulmonary, or renal dysfunctions. 3. sign informed consent voluntarily. 4. patients aged between 16 and 70 years old, male or female is permitted. 5. ecog performance status score less than 1. 6. the expected survival is longer than 3 months. exclusion criteria: 1. with other malignant tumors. 2. patients received the treatment of cladribine or venetoclax. 3. patients received cardiac angioplasty or stent implantation. 4. active infections that are not under clinical control (bacteria or fungus or virus is included). 5. liver functions abnormalities (total bilirubin\>1.5 times the upper limit of the normal range, alt/ast\>2.5 times the upper limit of the normal range or patients with liver involvement whose alt/ast\>1.5 times the upper limit of the normal range), or renal anomalies (serum creatinine\>1.5 times the upper limit of normal value). 6. pregnant or nursing women. 7. patients with mental disorders or other conditions whereby informed consent cannot be obtained and where the requirements of the study treatment and procedures cannot be met. 8. patients participated in any other clinical trials 3 months prior to signing the informed consent. 9. patients not suitable for the study according to the investigator's assessment.

Keywords: cav regimen hsct
retrospective analyses of the greenbrook database evaluating mental health treatments

Conditions: Depression; OCD; Anxiety Depression

Summary: the study involves multiple retrospective analyses to understand the utilization of mental health treatments provided at greenbrook and their effectiveness

this is a retrospective data analysis study that will utilize the already collected data as clinical care and will help understand the utilization and efficacy of various treatment options available for various mental heath conditions.

Eligibility criteria:
inclusion criteria: * male or female reported in database and not an invalid entry * age reported and not an invalid entry * treatment date in 2011 or later. exclusion criteria: • incomplete information on treatment parameters
beatboxing and residual speech errors

Conditions: Speech Sound Disorder

Summary: this project will study the effect of practicing speech sounds via beatboxing on speech accuracy, engagement in therapy, and functional outcomes for older children and adolescents with speech sound disorders (ssds). though ssds exhibited by young children are often considered, ssds are among the most frequent communication disorders in school-aged and adolescent children. ssds can persist until adulthood. individuals exhibit residual speech errors (rse) when speech sounds are produced incorrectly after the age of eight, the age at which speech production is expected to be error-free. common rse include /r/, /s/, and /z/, all of which have high frequency in american english. beatboxing is a unique manipulation of the speech mechanism in which the individual creates repetitive, percussive and other instrumental sounds by actually being the instrument. beatboxing is engaging and increasingly found in a variety of musical contexts and mainstream culture. the broad objective of this investigation is to explore the impact of beatboxing as an intervention tool on the speech produced and the functional outcomes attained by children with rse compared to a traditional articulation therapy approach.the effect of a beatboxing intervention approach (beat-speech) will be compared to traditional articulation therapy and employs a two-group pretest-posttest design. specifically, the research aims to 1) assess the impact of beatboxing on speech sound production accuracy and amount of targets produced during therapy; 2) examine the relative level of client engagement of individuals exposed to beatboxing intervention; and 3) explore influences of beatboxing experiences on communication, activities, and participation in social and daily interactions.


Eligibility criteria:
inclusion criteria: • diagnosed with a speech sound disorder due to residual speech sound errors exclusion criteria: * out of age range * history of hearing, neurogenic, behavioral diagnoses that can contribute to speech disorder * english is not first or preferred language * concurrent treatment for speech goals
investigating the clinical consequences of flutemetamol-pet-scanning

Conditions: Mild Cognitive Impairment; Alzheimer's Disease; Dementia

Summary: the study examines subjects where there might be an indication for amyloid-pet according to the criteria defined by the amyloid imaging task force. in these subjects the impact of a flutemetamol (vizamyl)-positron-emission-tomography -scan (pet) on clinical management and disease course will be studied over 6 months.


Eligibility criteria:
inclusion criteria: * dementia expert considers an amyloid-scan appropriate according to amyloid-imaging task force criteria (ait) after conference with an amyloid-pet expert * preambles of the ait-criteria are fulfilled 1. a cognitive complaint with objectively confirmed impairment 2. ad as a possible diagnosis, but when the diagnosis is uncertain after a comprehensive evaluation by a dementia expert 3. when knowledge of the presence or absence of abeta pathology is expected to increase diagnostic certainty and alter management 1. patients with persistent or progressive unexplained mci 2. patients satisfying core clinical criteria for possible ad because of unclear clinical presentation, either an atypical clinical course or an etiologically mixed presentation 3. patients with progressive dementia and atypically early age of onset (65 years or less in age) 4. other situations where preambles of ait-criteria are fulfilled * diagnosis was established in a memory clinic or by an experienced physician in dementia diagnostics * the diagnostic procedures comprise in minimum mri, neuropsychology, routine blood test for exclusion of symptomatic causes * mmse \>15 * competency to consent * trial partner willing to support study physician * written informed consent by both patient and trial partner * understanding of german language * treating physician willing to collaborate with the study team exclusion criteria: * cognitive impairment which can be attributed to another underlying medical condition that renders a possibility of alzheimer's disease very unlikely (thus violating preamble b) * clinically significant depression (decided upon clinical assessment) * mri exclusion criteria * pet exclusion criteria 1. allergy to flutemetamol or any of the excipients of the solution for injections 2. history of severe allergic reactions to drugs or allergens 3. pregnancy or lactation

Keywords: mild cognitive impairment alzheimer pet amyloid frontotemporal