Kornimate/medical-research-clean huggingface dataset:
efficacy and safety study of cb-5945 for the treatment of opioid-induced constipation

Conditions: Opioid-Induced Constipation

Summary: the purpose of this study is to evaluate the safety and efficacy of cb-5945 for the treatment of opioid-induced constipation (oic) in adults taking opioid therapy for chronic non-cancer pain.

this is a multicenter, double-blind, placebo-controlled, parallel-group study in participants with oic taking opioid therapy for chronic non-cancer pain. approximately 600 participants (300 participants per treatment group) with oic will be randomized at approximately 75 study centers to receive either oral 0.25 mg cb-5945 bid or oral matching placebo bid for the 12-week double-blind treatment period, followed by a 4-week follow-up period. all randomized participants will be evaluated for clinical response for duration of their study participation. all participants will be followed for safety for 4 weeks after last dose of the study medication, regardless of when they discontinue study medication. the clinical study report for this study includes pooled results for studies 5945-oic-12-02 (nct01901302) 5945-oic-12-03 (nct01901328), and 5945-oic-12-04 (nct01901341).

Eligibility criteria:
key inclusion criteria: * is taking a stable daily dose of opioids of ≥30 mg morphine equivalent total daily dose (metdd) for chronic non-cancer pain * has constipation that is caused by the chronic use of opioids * is willing to use only the study provided laxative(s) and to discontinue use of all other laxatives, enemas, stool softeners, and other medications to treat constipation (e.g., lubiprostone) from screening until the last study assessment key exclusion criteria: * has gastrointestinal (gi) or pelvic disorders known to affect bowel transit (for example \[e.g.\], obstruction) or contribute to bowel dysfunction * has evidence of intestinal obstruction * has a history of rectal bleeding not due to hemorrhoids or fissures within 6 months of screening * has an active malignancy of any type (participants with a history of successfully treated malignancy \>5 years before the scheduled administration of study medication and participants with treated basal or squamous cell cancer may be enrolled) * is taking antispasmodics (e.g., dicyclomine), antidiarrheals (e.g., loperamide), prokinetics (e.g., metoclopramide), or locally acting chloride channel activators (e.g., lubiprostone) * is taking non-opioid medications known to cause constipation (e.g., iron sulfate therapy, tricyclic antidepressants)

Keywords: opioid constipation chronic pain
the efficacy of hlx208 (braf v600e inhibitor) for refractory primary brain tumors with braf mutation after first-line treatment

Conditions: Brain Tumor, Primary

Summary: an open-label, multicenter phase ii clinical study to evaluate safety, efficacy and pk of hlx208 for refractory primary brain tumors with braf mutation


Eligibility criteria:
inclusion criteria: * age\>=18y * good organ function * expected survival time ≥ 3 months * refractory primary brain tumors with braf mutation that have been diagnosed * unable to receive surgery/radiotherapy, or have treatment failed after surgery/radiotherapy * ecog score 0-1; exclusion criteria: * previous treatment with braf inhibitors or mek inhibitors * a history of other malignancies within two years, except for cured cervical carcinoma in situ, basal cell carcinoma of the skin, adenocarcinoma in situ of the lung, or tumors that do not require interventional treatment after radical surgery * severe active infections requiring systemic anti-infective therapy * other anti-tumor treatments, such as chemotherapy, targeted therapy, or radiation therapy (except palliative radiation therapy), may be given during the study period.
assessment of the ionizing radiation received during percutaneous or conventional surgery of hallux valgus

Conditions: Hallux Valgus; Surgery

Summary: to assess the average whole body radiation dose received by the surgeon, the operating team and the patient during hallux valgus surgery, depending on whether the surgery is percutaneous or conventional.

prospective, open, comparative, non-randomized, non-interventional, single-center study, focusing on two surgical strategies. patients will be managed in accordance with current practice, the choice of surgical strategy being left to the discretion of the investigators. patients will be informed of the study during a preoperative visit. the data concerning them will be collected on the day of the surgery. no follow-up over time is necessary. passive "ring" and "cornea" dosimeters will be worn by healthcare professionals during procedures for patients included in the study. their data will be collected each month and at the end of the study, and reported secondarily to the number of operations. several surgeons, dressers and operating assistants will participate in the operations, their data will be aggregated taking into account their function and not individuals.

Eligibility criteria:
inclusion criteria: * patient undergoing percutaneous or conventional hallux valgus surgery; * patient capable of understanding the information related to the study, of reading the information leaflet and having expressed his non-opposition to participating in the study. exclusion criteria: * pregnant or breastfeeding woman; * patient under guardianship or curatorship, or under a regime of deprivation of liberty.
early mobilization in older adults with acute cardiovascular disease

Conditions: Early Mobilization; Older Adults; Acute Cardiovascular Disease; Nursing

Summary: the em-heart study is a prospective, multi-centre stepped wedge cluster randomized trial to evaluate the effectiveness of a pragmatic early mobilization (em) program to improve patient-centred and clinical outcomes in older adults with acute cv disease. there will be 256 participants ≥60 years old with acute cv disease enrolled at 6 participating canadian hospitals. the study will investigate whether em improves functional status during admission, as compared to usual care, and whether this leads to improved health-related quality of life post-hospitalization. functional status will be measured with the validated level of function mobility scale. the primary outcome will be the short-form sf-36 physical component scale score at 1-month post-hospitalization. secondary outcomes include functional status and hospital readmission at 1-month post-hospitalization.

the em-heart study is a prospective, multi-centre stepped wedge cluster randomized trial to evaluate the effectiveness of a pragmatic em program to improve patient-centred and clinical outcomes in older adults with acute cv disease. there will be 256 participants ≥60 years old with acute cv disease enrolled at 6 participating canadian hospitals. the study will investigate whether em improves functional status during admission, as compared to usual care, and whether this leads to improved health-related quality of life post-hospitalization. functional status will be measured with the validated level of function mobility scale. the primary outcome will be the short-form sf-36 physical component scale score at 1-month post-hospitalization. secondary outcomes include functional status and hospital readmission at 1-month post-hospitalization. nested cohort studies will explore (1) the relationship between em, sedentary time, and posthospitalization outcomes and (2) the impact of em on muscle mass loss and inflammation in older adults with acute cv disease.

Eligibility criteria:
inclusion criteria: * age ≥ 60 years * no planned cardiac surgery during admission exclusion criteria: * projected cardiac icu stays less than 24 hours * patients unable to complete follow-up
retrospective epidemiological study on botulism in intensive care units in france

Conditions: Botulism; Poisoning

Summary: botulism poisoning is a rare but serious illness. because of it's low incidence, it is not well known by physicians. most studies describing botulism date back to the last century and do not take into account recent advances in intensive care. the objective of this study is to describe the clinical course, interventions and outcomes of patients with severe botulism poisoning requiring a hospitalisation in an intensive care or high dependancy unit.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of botulism * admission in an intensive care or high dependancy unit exclusion criteria: * none

Keywords: botulism intensive care
evaluation of intra-operative photographs for the assessment of a proper lymphadenectomy in minimally-invasive gastrectomies for gastric cancer (photonodes)

Conditions: Gastric Cancer; Gastric Adenocarcinoma; Lymphadenectomy; Minimally Invasive Surgery; Gastrectomy for Gastric Cancer; Laparoscopic Surgery; Robotic Surgery; Survival Outcomes; Survival Analysis; Quality Of Care

Summary: even after the wide introduction of chemo/radiotherapy in the treatment algorithm, adequate surgery remains the cornerstone of gastric cancer treatment with curative intent. a proper d2 lymphadenectomy is associated with improved cancer specific survival as confirmed in western countries by fifteen-year follow-up results of dutch and italian randomized trials. in clinical practice, the total number of harvested lymph nodes is often considered as a surrogate marker for adequate d2 lymphadenectomy; nonetheless, the number of retrieved nodes does not necessarily correlate with residual nodes, which intuitively could represent a more reliable marker of surgical adequacy. the availability of an efficient tool for evaluating the absence of residual nodes in the operative field at the end of node dissection could better correlate with survival outcomes. the goal of this multicentric observational prospective study is to test the reliability of a new score (photonodes score) created to rate the quality of the lymphadenectomy performed during minimally invasive gastrectomy for gastric cancer. the score is assigned by assessing the absence of residual nodes at the end of node dissection on a set of laparoscopic/robotic high quality intraoperative images collected from each patient undergoing a minimally invasive gastrectomy with d2 node dissection. ideally, this tool could be a new indicator of the quality of d2 dissection and could assume a prognostic role in the treatment of gastric cancer.


Eligibility criteria:
inclusion criteria: * all patients undergoing minimally invasive curative-intent surgery for gastric adenocarcinoma with d2 lymphadenectomy * patients undergoing upfront surgery or treated with a neoadjuvant/perioperative chemotherapy * total or subtotal gastrectomy * laparoscopic or robotic approach exclusion criteria: * age less than 18 year old * esophago-gastric junction cancer siewert type i, ii or iii * metastatic disease * lymphadenectomy less than d2 * open surgery * conversion to open surgery * palliative gastrectomy * r1 or r2 resection * multivisceral resection except for cholecystectomy * surgical procedures other than subtotal or total gastrectomy * a single node station rated as unevaluable by more than one reviewer

Keywords: d2 lymphadenectomy quality assessment minimally invasive gastric cancer oncologic surgery
smoking cessation in patients after coronary angiography

Conditions: Coronary Artery Disease

Summary: objectives the goal of this study is to evaluate the self-achieved smoking cessation supported with cytisine smoking cessation and its' on platelet aggregation and prothrombotic state in patients after coronary angiography and pci. background cigarette smoking is a major risk factor of coronary artery disease (cad). smoking cessation is one of the most cost-effective intervention in lifestyle. self-reported rates of smoking cessation are reasonably low. cytisine is promising drug in support of smoking cessation. smoking affects various components leading to arterial thrombosis, and the effect of smoking cessation on prothrombotic state and platelet aggregation is still under investigation goal to assess rates of smoking cessation in patients after coronary angiography and pci and factors influencing success in smoking cessation to assess feasibility, safety and efficacy of cytisine in smoking patients to assess effect of smoking cessation on platelet aggregation in patients treated with clopidogrel and on prothrombotic state. methods a prospective nonrandomized observational study of patients after coronary angiography.


Eligibility criteria:
inclusion criteria: * patients after coronary angiography or pci, * aged 18 years or older, * smoking at least 10 cigarettes a day exclusion criteria: • pregnancy criteria may vary in substudies
efficacy of high flow nasal oxygen during sleep endoscopy in patients of obstructive sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: the purpose of this study is to investigate the utility of high-flow nasal oxygen during sleep endoscopy in obstructive sleep apnea patients.


Eligibility criteria:
inclusion criteria: * adult patients aged over 19 years who are scheduled for sleep endoscopy exclusion criteria: * 1) basal skull fracture, 2) facial anomaly, 3) consciousness disorder, 4) risk of aspiration, 5) necessity of awake fiberoptic intubation due to the large vocal cord mass, endotracheal tumor or bleeding.
red blood cells (rbc) transfusion related to central venous o2 saturation (scvo2) measurement

Conditions: Postoperative Complications; Erythrocyte Transfusion; Oxygen Disorders

Summary: the objective of this study is to estimate red blood cells (rbc) transfusion related to central venous o2 saturation (scvo2) measurement. this prospective, randomized trial is performed in visceral, vascular and thoracic surgery units in the university hospital of lille. one hundred patients need to be included. inclusion criteria are: age 18 to 99 year old, patient with central venous catheter in place and fulfilling the haemoglobin (hb) threshold criteria for rbc transfusion according to the xxiiith french consensus conference in critical care medicine recommendations. after randomisation, patients will be eligible to receive rbc according to their level of hb in the standard group and according to the hb and scvo2 in the optimization group. patients without any disease are transfused if their hb level is below 7g/dl; patients older than 60 years or having sepsis are transfused if their hb level is 8g/dl or lower and cardiac patients are transfused if their hb level is 9g/dl or lower. in the second group, transfusion is performed if and only if the scvo2 level is les than 70% when hb is under the same threshold levels. the primary aim of the study is to compare the number of rbc units transfused by group (standard group or optimization group) over a period of 5 days counted from the first decision of transfusion taken post-operative. considering the randomisation and considering the 50 % reduction of the decisions of transfusion in the group optimization, the absolute blood savings is estimated 25 % for the whole population. secondary end points include the number of side effects associated with transfusion or when avoiding transfusion, length of hospital stay, and hospital mortality as well as major adverse events.

red blood cells central venous o2 saturation surgery transfusion xxiiith french consensus conference adult

Eligibility criteria:
inclusion criteria: * central venous catheter * anemia with reference to french consensus about transfusion exclusion criteria: * intensive care * emergency transfusion * shock, hypovolemia * need to go under surgery into 4 hours * acute kidney injury or chronic renal disease * brain injury * pregnancy * heart disease : ischemia \<1 mois

Keywords: postoperative care red blood cell transfusion venous oxygen saturation
surveying patient's interest in robotic rehabilitation device

Conditions: Stroke, Acute

Summary: this is a survey study to understand the stroke survivor's interest in robotic training. investigators will use a questionnaire and show a video of robotic therapy to ask questions on their interest.

the purpose of this research is to investigate the interest of individuals with recent stroke in robotic therapy. investigators will introduce a novel robotic platform to train adls of stroke patients. investigators will examine the usability of this device as a home trainer for training rotational hand manipulation tasks such as opening a pickle jar, turning a key, missing a pot with a ladle, etc. the device will especially target stroke patients with ischemic stroke to enhance the performance of adl. also, investigators will examine the frequency and dosage of the current occupational therapy, followed by the satisfaction of the current therapy. participant's participation will contribute to the development of a new therapy method using a robotic device for home-based training.

Eligibility criteria:
inclusion criteria: * adults with stroke * adults with no cognitive difficulties exclusion criteria: * adults with pregnancy, * adults with other neurological disorders than stroke * adults with hemorrhagic stroke
the role of local anesthetics in the management of adverse effects associated with intrauterine device application

Conditions: IUD; Contraception; Pain

Summary: patients who visited our family planning clinic and opted for iud application for contraception purposes were also offered nt/tla treatments simultaneously. 40 patients who matched the inclusion criteria and received iuds and nt/tla treatments were included in the study group and 41 patients who only received iuds were included in the control group. all patients received copper iuds and none of them were on additional hormonal treatment. before the insertion of iud, women in the therapy group received nt treatment with 6ml of 1% procaine injected transvaginal into the cervix at 5 and 7 o'clock localizations. following iud insertion, another 6ml of 1% procaine was injected into the frankenhauser ganglia bilaterally. a final dose of 8ml of 1% procaine was injected into the abdominal trigger points and intracutaneously into the l4-s4 dermatomes as quaddles.


Eligibility criteria:
inclusion criteria: * not pregnant women * healty women age between 18- 45 years old exclusion criteria: * chronic diseases which could cause chronic pelvic pain such as endometriosis * which makes them prone to infections such as diabetes mellitus * complication had arised during the iud insertion, such as uterine perforation
non-invasive neuromodulation in children with neurodevelopmental disorders

Conditions: Neurodevelopmental Disorders

Summary: children with neurodevelopmental disorders have a delay in acquiring the skills that are assumed considering the phases of typical psychomotor development. added to this difficulty and main element of concern on the part of their families, there are another series of signs that appear with some frequency and that, despite being unnoticed against other major problems represent basic and fundamental factors in the correct development and performance such as constipation problems and sleep disorders. the aim of the study consists of to evaluate the effectiveness and safety of the non-invasive neuromodulation device applied in people with neurodevelopmental disorders, in relation to constipation problems and in the quality of sleep.

while the application is being sent to the ethics committee, we will hold a series of informative talks for the centre's staff who, in one way or another, will be involved in the development of the project. at the same time, information letters will be sent to the parents or legal representatives of the children who will a priori be part of the project, as well as the corresponding informed consent. in addition, they will be sent the screening documents that will allow us to confirm if the selected subject has constipation problems and/or sleep disorders. the intervention period per subject will be 12 sessions, distributed in three sessions per week (monday, wednesday, and friday), estimating that the intervention can be completed after one month. during school hours, the participants will receive their own treatment, agreed by their multidisciplinary team with common and personal objectives for the subjects, so that there will be no interruption of their usual routine. two weeks after the intervention, a new assessment will be carried out to assess whether the possible changes recorded during the intervention phase have been maintained.

Eligibility criteria:
inclusion criteria: * sensory-motor alteration. * be schooled in the center of the city san juan de dios of las palmas de gran canaria. * meet the criteria established by the rome iv constipation scale. * informed consent signed by the family, guardian or legal representative. exclusion criteria: * no contraindications to treatment with nxsignal: pacemaker, internal bleeding, do not apply electrodes on skin in poor condition, with ulcerations or wounds, acute febrile processes, acute thrombophlebitis and/or phobia to electricity. * epilepsia. * subjects who modify eating habits and/or water intake.

Keywords: physical therapy modality electric stimulation therapy child development disorders