Kornimate/medical-research-clean huggingface dataset:
study on impact of edoxaban treatment in cancer patients with venous thromboembolism during antineoplastic therapy

Conditions: Thromboembolism; Cancer

Summary: this is a multicentric, phase iv study. in this study patients that are receiving an antineoplastic treatment and that have been diagnosed with venous thromboembolism will receive edoxaban as per clinical practice. edoxaban will be administered according to summary of product characteristics. patients will receive 6 to 12 months of treatment with edoxaban administered orally. the thromboembolic event will be monitored as per local clinical practice. in this study patients will be evaluated at baseline, at the beginning of therapy with edoxaban, after 1 month (+/- 7 days), after 3, 6 and 12 months (+/- 3 weeks). during these visits, patients will be provided of a diary in which they should report drug intake and interruptions and quality of life questionnaires.


Eligibility criteria:
inclusion criteria: * adult subjects presenting with vte (venous thromboembolism) associated with cancer (other than basal-cell or squamous-cell carcinoma of the skin). cancer diagnosis should be done within two years prior to vte. * patient must be receiving systemic antineoplastic therapy (such as chemotherapy, target therapy, immunotherapy, hormonotherapy) and remain candidate to receive at least other 3 months of anti neoplastic therapy. exclusion criteria: * hypersensitivity to the active substance or to any of the excipients; * clinically significant active bleeding; * hepatic disease associated with coagulopathy and clinically relevant bleeding risk; * lesion or condition, if considered to be a significant risk for major bleeding. this may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities; * uncontrolled severe hypertension; * concomitant treatment with any other anticoagulants * pregnancy and breast-feeding.
hot axios™ for bile duct drainage in malignant stenosis

Conditions: Malignant Biliary Stenosis

Summary: the study is designed to highlight the effectiveness of the hot axios™ stent when used in accordance with standard medical practice on the evolution of the quality of life of patients with malignant biliary stenosis requiring drainage of the bile ducts after failure of ercp, in the two months after stent placement.

the study will evaluate the quality of life in patients with malignant biliary obstruction after the placement of a lumen-apposing metal stent via endoscopic ultrasound, with an emphasis on the improvement of quality of life measured as a reduction in jaundice. improvement in jaundice is a direct indicator of effective bile drainage and is expected to correlate with an enhancement in overall quality of life. quality of life will be measured by means of subject response to the eortc qlq-bil21, a component of the european organization for research and treatment of cancer (eortc) designed specifically to assess the quality of life in patients with biliary tract cancer. the qlq-bil21 consists of 21 questions which aim to evaluate specific symptoms and issues relevant to patients with biliary tract cancer, such as jaundice, pain, digestive problems and the psychosocial impact of the disease.

Eligibility criteria:
inclusion criteria: 1. patients 18 years or older 2. willing and able to comply with study procedures and provide written informed consent 3. patients with failed ercp for treatment of malignant biliary obstruction 4. patients for whom an indication for hot axios™ stent placement has been determined exclusion criteria: 1. women who are pregnant, nursing or planning to become pregnant during the study 2. patients with immediately resectable tumor 3. patients for whom the placement of a double pigtail prosthesis is planned by the investigator during the index procedure 4. current participation in another investigation drug or device study that could interfere with the endpoints of this study 5. persons under guardianship or curatorship
virtual scale function scale eye: variability and systematic differences

Conditions: Polyp of Colon

Summary: size of colorectal polyps is important to decide on appropriate surveillance intervals and treatment modality, as well as carrying out optical diagnosis strategies. however, polyp size measurement is often prone to inter-observer variability. an easy and accurate tool to assist in polyp size measurement is required. recently, a virtual scale function for size measurement during endoscopy (scale eye), operating in real-time without the use of any additional devices, has been developed. the aim of this study is to assess whether use of the scale eye for polyp size measurement can reduce inter-observer variability.

this study is designed as a single center prospective study. polyp size measurements using scale eye will be compared with several other polyp size measurement techniques: size measurements by endoscopists without a reference ('carpenters eye') , size measurements by endoscopists with an opened snare (of known size) as reference and size measurements by the pathologist during histopathological analysis. during screening colonoscopies, detected polyps (maximum of four per colonoscopy) will be measured using all three different colonoscopy measurement techniques. this will be done by experienced endoscopists (endoscopist accredited for colonoscopies within the national colorectal cancer screening program). since endoscopists measure polyps in multiple ways, consecutive measurements of the same polyp will be biased. for this reason, all polyp size measurements will be recorded on video. the video recordings of the different measurements of all polyps will be presented to eight expert endoscopists and four to eight trainees (depending on availability) in a randomized order. the size estimations based on these video recordings will be used for further analysis. histopathological analysis and size measurements of the resected polyps will be performed by pathologists with expertise in gastrointestinal pathology. variability and systematic differences in polyp size measurement between different measurements methods will be assessed.

Eligibility criteria:
inclusion criteria: * age \>18 years * screening colonoscopy after positive fecal immunochemical test (fit) within the dutch colorectal cancer screening program * signed informed consent exclusion criteria: * diagnosis of inflammatory bowel disease, lynch syndrome or (serrated) polyposis syndrome

Keywords: colorectal polyp size scale eye virtual scale
cognitive therapy in patients failing art

Conditions: HIV; Cognitive Therapy

Summary: highly active antiretroviral therapy (haart) has been the greatest achievement to control the hiv/aids epidemic in the world. haart has been shown to reduce virus replication to undetectable levels and to favor the recovery of immune function, avoiding the occurrence of opportunistic diseases. although existing treatments have been shown to lower aids-related morbimortality and to increase patients' quality of life, the success of haart requires high levels of adherence to the prescribed treatment regimen. adherence to haart has become the major challenge for global public policy managers and healthcare teams involved in the care of hiv/aids patients. mental healthcare professionals should use structured and effective intervention as strategies to facilitate a better approach, increase patients' autonomy and achieve optimal adherence. trial-based cognitive therapy (tbct) is a new, structured, and short-term version of cognitive behavior therapy developed by de oliveira (2011). tbct is an active approach that aims to change negative cognitions, especially dysfunctional core beliefs, that negatively influence patient's life in different domains. tbct helps patients recognize situationally based thoughts, unhelpful beliefs and maladaptive behaviors that exacerbate emotional distress. this study aims to assess the efficacy of tbct in helping the patients to identify thoughts, emotions, assumptions and behaviors associated with non-adherence to antiretroviral therapy, and to improve adherence to treatment.


Eligibility criteria:
inclusion criteria: * the last two detectable cv \> 500 copies * at least one year of antiretroviral treatment * age between 18 and 65 years * literate person. exclusion criteria: * difficulty to read and to write * being currently in psychotherapy * clinical diagnoses of neurocognitive or psychotic disorders

Keywords: hiv cognitive therapy treatment haart treatment adherence and compliance
osteoporosis awareness survey of women in champagne ardenne

Conditions: Osteoporosis

Summary: osteoporosis is characterized by low bone mineral density and alterations in bone microarchitecture, leading to bone fragility and high risk of fractures. in the peri-menopausal period and during menopause, estrogen deficiency is responsible for an acceleration of bone remodeling. it is therefore important to sensitize women to this pathology at the beginning of menopause. osteoporosis is a public health issue with more than 3 million women in france suffering from almost ¼ of the population over 50 years old. paradoxically, the number of bone densitometry and prescribed osteoporosis drugs are decreasing. there is an under-screening and a disinterest of the pathology on the part of the medical world and the patients. the investigators hypothesize that women lack knowledge about osteoporosis. this study will identify these gaps, and put in place appropriate strategies to improve this knowledge. for this purpose, a descriptive cross-sectional observational study will carry out, through the fulfillment of self-administered questionnaire for women over 30 years old. the main objective is to assess the knowledge of women, about osteoporosis and its consequences. the judgment criterion is based on a percentage of correct answers per question. the interests of the study are to identify gaps in knowledge, to optimize the investigator's therapeutic education, to fight patient wait-and-see and false beliefs, and finally to improve adherence and longer-term adherence.

this is a descriptive cross-sectional observational study, recruiting women over 30 years old, by the diffusion of the questionnaire in the general practices of champagne-ardenne, and the rheumatology department of chu de reims. the main objective of the study is to assess the knowledge of women over 30 on osteoporosis and its consequences. the judgment criterion is a calculation of the percentage of correct answers per question. the investigation plan is based on a self-administered questionnaire survey .the statistical analysis plan is based on a descriptive analysis with sorting flat and sorted; the questionnaires will be disseminated from march 2018 to may 2018, with the valuation of results on june 1, 2018. this questionnaire includes: * 6 questions relating to the patient : risk of osteoporosis and specific management. * 17 questions about osteoporosis knowledge * 8 questions about information resources received on osteoporosis ( media, general practitioner ...) the questionnaire will be accompanied by a cover letter and a consent form. the filling of the questionnaire should last between 5 and 7 minutes. the patient will then give back the questionnaire directly to the person who has offered him to fill it out (general practitioner, rheumatologist, nurse). the questionnaires will be placed in waiting rooms of doctors, dentists, and paramedics of the marne, the ardennes, and the aube.

Eligibility criteria:
inclusion criteria : * gender : women * age over thirty years old exclusion criteria : * cognitive state incompatible with the collection of information * women doctors
nine-weeks treatment with 683699 in subjects with moderately-to-severely active crohn's disease

Conditions: Crohn's Disease

Summary: this study will evaluate the effectiveness and safety of the investigational drug 683699 in treating subjects with moderately to severely active cd (crohn's disease).


Eligibility criteria:
inclusion criteria: * diagnosed with cd and reconfirmed in previous 2 years by a radiologic or endoscopic assessment including histology. * cdai (crohn's disease activity index) score of 220-450 after 1 week of screening. * crp (c-reactive protein) level of \>4mg at screening. exclusion criteria: * significantly abnormal laboratory tests or ecg (electrocardiogram) results. * current use of an elemental diet or parenteral nutrition. * clinically significant positive stool culture. * ongoing neoplastic disease of the bowel. * bowel perforation other than fistulae. * has an ileostomy or colostomy. * fixed symptomatic gastrointestinal (gi) stricture within 6 months or obstructive symptoms within 3 months of screening. * any bowel resection within 12 months of screening or bowel resection without subsequent demonstration of recurrence of active cd. * more than 100cm of bowel resected. * non-curative bowel surgery with 2 months of screening. * symptoms attributed to short bowel syndrome. * uncontrolled bacterial, viral, or fungal infection or congenital or acquired immunodeficiency. * women who are pregnant, breast feeding, or planning to become pregnant during the study. permitted medications: * less than or equal to 20mg/day oral corticosteroids for at least 4 weeks prior to screening and on stable doses for 2 weeks prior to screening. * azathioprine and 6-mp (6-mercaptopurine) stable dose for 3 months prior to screening. * 5-asa (5-aminosalicylic acid) stable dose for 1 month prior to screening. prohibited medications: * greater than 20mg/day oral corticosteroids, or systemic intravenous corticosteroids, or antibiotics as a treatment for cd within 4 weeks prior to screening. * cyclosporine or methotrexate during the 2 months prior to screening. * infliximab or other biological treatments within 3 months prior to screening.

Keywords: cd crohn's disease
evaluation of a peer counseling breastfeeding support program for mother-preterm infant dyads

Conditions: Infant Premature

Summary: breastfeeding has a fundamental impact on the short-, medium- and long-term health of children and has an important impact on women's health. breastfeeding protects against gastrointestinal and respiratory illnesses and is associated with better cognitive development in childhood, particularly in preterm infants. despite these potential benefits, preterm infants experience lower rates of breastfeeding initiation and continuation compared to term infants. the use of breastfeeding peer support initiatives, in which advice is given by experienced and trained peer counselors, is an effective way to promote and support breastfeeding, regardless of a woman's socioeconomic status. several small studies have shown that breastfeeding peer support initiatives were effective for preterm infants and that this efficacy was increased by the co-intervention of lactation consultants. the purpose of this study is to develop and to evaluate the effectiveness of a breastfeeding support program among mother-preterm infant dyads in europe, by evaluating the impact of the intervention on 1) breastfeeding rates, 2) morbidity and mortality during the hospitalization, 3) children's cognitive development and behavior 4) mothers' mental health, 4) costs benefits. the breastfeeding support program will include peer counselors under the supervision of lactation consultants. breastfeeding counselors will be voluntary mothers who have had a positive breastfeeding experience with at least one preterm infant. after a training course, they will meet the future or new mothers by face-to-face and share their experiences at least once a week during hospitalization and provide phone support up to 1 month after discharge from hospital. the study design will be a stepped wedge cluster trial conducted in 8 nicu in europe (france, switzerland and belgium). infants and mothers will be followed up from the time of hospitalization in the maternity and nicu up to 6 months after the discharge. the cost analysis will be performed in a subgroup of mother-preterm infant dyads that will be followed up at 24-months after their discharge


Eligibility criteria:
inclusion criteria: * any infant born \<35 weeks' gestation, * hospitalised in nicu before 24 hours old * and younger than 168 hours (7 days) old. exclusion criteria: * infant with foetal malformation that is life-threatening * infant with medical contraindication for breastfeeding * parent(s)' non-consent to be involved in the study * mother with prolonged medical contraindication for breastfeeding * mother with psychiatric disorders making breastfeeding support impossible * if no communication is possible with the mother * if the level of communication with the mother does not allow breastfeeding support, with or without a third party

Keywords: breastfeeding mother-to-mother support lactation consultant stepped wedge cluster randomized trial peer counseling
observational study with novocart® inject in the reconstruction of the hip joint with full thickness cartilage defects

Conditions: Cartilage Disease

Summary: non-interventional study to evaluate safety and efficacy of novocart® inject in patients with full thickness cartilage defects in the hip.

prospective and multicenter non-interventional study to evaluate safety and efficacy of novocart® inject in patients with impingement syndrom in the hip. safety: 24-month post treatment follow up period by measuring the number of adverse drug reactions/serious adverse drug reactions. efficacy: 24-month post treatment follow up period using ihot 33 and euroquol-5d-5l.

Eligibility criteria:
inclusion criteria: * male and female patients between 18 and 60 years * insulated full thickness cartilage damage of the hip joint after icrs grade 3 * received subchondral bone lamella * received or reconstructed labrum in labrum cartilage defects * defect size ≥ 1.5 and ≤ 10 cm2 * intact surrounding cartilage structure around the defect, and the corresponding articular surface * existence of the written informed consent of the patients after enlightenment exclusion criteria: * more than 2 defects or 2 corresponding defects * defects in both lower extremities simultaneously * radiographic signs of osteoarthritis of kellgren \& lawrence \> 1 * profound bony lesion \> 0.5 cm in the defect area * presence of rheumatoid, infectious or para-infectious arthritis, as well as state after these diseases * skin injury to the limb to be operated on * cartilage defect of the corresponding articular surface * existing medications, drugs or alcohol * acute infectious diseases, chronic cardiovascular disease, endocrine or metabolic disorders, autoimmune or neoplastic diseases * impairment of the upper extremity, which prevents discharge by crutches * known bleeding disorder, such as hemophilia a / b or thrombophilia * pregnancy and lactation, which represent the time of treatment is a contraindication * known allergy to the ingredients * inmates in prisons

Keywords: cartilage defect hip impingement
efficacy of evidence-based ptsd treatment via prebiotic supplementation

Conditions: Post Traumatic Stress Disorder

Summary: posttraumatic stress disorder (ptsd) is a debilitating psychiatric disorder, which results from exposure to traumatic events. veterans are more than twice as likely to suffer from ptsd compared to civilians. current interventions for the treatment of ptsd are evidence-based psychotherapies, such as cognitive processing therapy (cpt). therefore, we plan to compare cognitive processing therapy (cpt) with and without a novel prebiotic bar designed to beneficially modulate the microbiota to determine the utility of this combined approach to positively impact ptsd symptoms. we will conduct a 12-week randomized, double-blind, placebo-controlled, cross-sectional trial in veterans with ptsd. participants will be randomized to receive cpt + prebiotic or cpt + placebo. they will be provided a supply of prebiotic or non prebiotic bars for 12 weeks. at three different time points, participants will complete questionnaires and complete questionnaires and produce a stool sample ( weeks 1,2, and 12). all participants will be recruited from the two-week in-person intensive outpatient program (iop) at the rush road home program, where they will be receiving cpt.


Eligibility criteria:
inclusion criteria: * veterans who are participating in the rush road home program 2-week intensive outpatient program (iop) and have the ability to consent. * ability and willingness to consume up to two prebiotic bars daily and collect stool samples. exclusion criteria: * active suicidality or homicidality, current engagement in significant non-suicidal self harm, history of mania or psychosis, current eating disorders, and/or current substance use that would require medical observation if discontinued. * gastrointestinal disease: (1) prior intestinal resection, (2) history of gi disease (except for hiatal hernia, nonproton pump inhibitor requiring gastroesophageal reflux disease, or hemorrhoids), (3) known renal disease or abnormal liver function, (4) antibiotic use within the previous 12 weeks, (5) a plan to have a major change in dietary habits during the study. * allergy to almonds, flax seed or coconuts
effect of biphasic insulin aspart 30 on blood glucose control in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial was conducted in russian federation. this trial aimed for a comparison of the effect on glycemic control in subjects with type 2 diabetes of three different treatment regimens: biphasic insulin aspart 30 thrice daily, biphasic insulin aspart 30 twice daily in combination with metformin and treatment with oral anti-diabetic drugs.


Eligibility criteria:
inclusion criteria: * type 2 diabetes, currently treated with one or more oral hypoglycemic agent * hba1c: at least 8.0% exclusion criteria: * impaired hepatic, renal or cardiac function
functional recovery effect of bloodletting puncture at jing-well points on acute brain injury patients

Conditions: Traumatic Brain Injury (TBI)

Summary: traumatic brain injury (traumatic brain injury, tbi) can be derived from various forms of injury, including blunt trauma, penetrating or acceleration/deceleration force caused by head injury.there are some study data show that acupuncture treatment has a superficial effect on the prognosis of traumatic brain injury and can limit the progression of secondary brain injury, but the effect of early bloodletting at the jing-points on tbi patients still unknown. in our study, the investigators have proposed a randomized, controlled study design and plan to evaluate the efficacy and safety of jing-point puncture to improve consciousness and neurological function in patients with tbi. in addition, an objective meridian instrument analysis was added to analyze the energy distribution in the meridian of tbi patients.


Eligibility criteria:
inclusion criteria: 1. patient with moderate to severe head injury are admitted to the icu (intensive care unit). patient with stable vital sign and the gcs (glasgow coma volume) between 5-13 will be included. 2. patient with normal consciousness and no cognitive or motor function disease before brain injury. 3. patient aged between 20 to 80 years old and is willing to sign the consent (the agent can sign on behalf of patient). exclusion criteria: 1. patients who are vital sign unstable and with severe complication. 2. patients combined with other terminal illness such as cancer in terminal stage, liver failure, end stage renal failure and so on. 3. pregnant patients. 4. any other conditions deemed unsuitable by the physician in charge. 5. patients (agent of the patient) who did not sign the consent.

Keywords: traumatic brain injury, tbi bloodletting acupuncture