Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of lenalidomide combined with azacitidine vs azacitidine in the treatment of mds-rs

Conditions: Myelodysplastic Syndromes

Summary: at present, the main therapies for myelodysplastic syndromes with ring sideroblasts (mds-rs) are red blood cell and platelet transfusion, erythropoietin (epo), androgen, and iron chelation therapy. lenalidomide is an immunomodulator with multiple mechanisms, including direct targeting of mds clones, immunomodulation, erythropoiesis restoration, and angiogenesis inhibition. a phase iii, randomized, placebo-controlled trial of oral azacitidine (aza) in lower-risk mds reported higher rates of hemoglobin and platelet hematological improvement in patients with aza monotherapy. therefore, this study intended to investigate the efficacy and safety of lenalidomide and sequential aza in the treatment of refractory mds-rs versus azacitidine monotherapy.

myelodysplastic neoplasms (mds) are heterogeneous clonal disorders of stem cells that result in peripheral blood cytopenia and ineffective hematopoiesis, with the potential risk of the development of acute myeloid leukemia (aml). most patients with myelodysplastic syndromes with ring sideroblasts (mds-rs) are stratified into lower-risk groups by the revised international prognostic scoring system (ipss). at present, the main therapies for mds-rs are red blood cell and platelet transfusion, erythropoietin (epo), androgen, and iron chelation therapy. lenalidomide is an immunomodulator with multiple mechanisms, including direct targeting of mds clones, immunomodulation, erythropoiesis restoration, and angiogenesis inhibition. hypomethylating agents (hma) like azacytidine (aza) and decitabine (dec), have been shown to improve survival or delay disease progression in high-risk mds. a phase iii, randomized, placebo-controlled trial of oral aza in lower-risk mds reported higher rates of hemoglobin and platelet hematological improvement in patients with aza monotherapy (24.3% vs 6.5%). therefore, this study intended to investigate the efficacy and safety of lenalidomide and sequential azacitidine in the treatment of refractory mds-rs versus azacitidine monotherapy.

Eligibility criteria:
inclusion criteria: 1. age \>18 years old. 2. patients with a definite diagnosis of mds-rs and stratified as lower-risk according to ipss-r. 3. after at least 3 months of rhepo treatment, with hemoglobin\<90g/l, absolute neutrophil count≥1.0× 109 /l, and platelet≥30× 109 /l 4. unconditional hematopoietic stem cell transplantation 5. adequate hepatic functions with alanine transaminase (alt)/aspartate. transaminase (ast) levels within 2 times of the normal upper limit and total bilirubin levels within 2 times of the normal upper limit. 5. no active infection; not pregnant or breastfeeding 6. ecog≦2 with an expected life span of more than 6 months 7. documented patient consent. exclusion criteria: 1. proliferative (white blood cell count ≥12× 109 /l) chronic myelomonocytic leukemia. 2. complicated with active or uncontrolled infections. 3. complicated with other malignancies. 4. creatinine/transaminase ≥ 2 normal upper limit. 5. complicated with myelofibrosis.
empower mechanisms

Conditions: Primary Biliary Cholangitis (PBC)

Summary: primary biliary cholangitis (pbc) is a chronic liver disease that can cause fatigue, itching, brain fog, and emotional distress, all of which can lower quality of life. while the standard treatment, ursodeoxycholic acid (udca), helps slow the disease, it does not relieve these symptoms. research shows that mind-body practices-such as breathing exercises, meditation, and gentle movement-can help improve mental and physical well-being in people with chronic conditions, but their benefits for pbc are not yet well understood. this study will test a 10-week online wellness program designed for women with pbc. the program will include guided breathing, meditation, and movement exercises, plus optional weekly group sessions and educational videos. some participants will also receive nutrition guidance on the mediterranean diet to see if it adds extra benefits. the study will evaluate feasibility via recruitment, adherence, and retention. to assess acceptability, participants will provide feedback through surveys and interviews. the study will also explore early signs of effectiveness by measuring changes in symptoms like anxiety, depression, fatigue, and stress, as well as biological markers, brain activity, physical function, and data from wearable devices. the results will help determine whether an online mind-body program, with or without nutrition support, could be a simple and effective way to help people with pbc manage their symptoms and improve their quality of life.


Eligibility criteria:
inclusion criteria: * primary biliary cholangitis (pbc) as confirmed by a study hepatologist using accepted clinical criteria * have been on stable medical therapy for pbc for ≥3 months * score ≥3 on a 1-10 numeric rating scale for two of: depression, anxiety, fatigue, sleep disturbance, cognitive impairment * are able to communicate in english * have access to an internet-connected device in their home * can commit to up to 60 minutes of study activities 5 days per week exclusion criteria: * unable to provide informed consent * have decompensated cirrhosis including hepatic encephalopathy * are post-liver transplant * current severe substance use or psychiatric disorder judged to interfere with study testing or program participation * are receiving compassionate care * have a clinical condition that makes the intervention unsafe or infeasible (e.g. unable to follow instruction) or unsafe environment for virtual participation * practices mind-body practices more than the study dose * have contraindications for mri * have colour blindness * are unable to attend baseline testing

Keywords: mind body wellness quality of life fatigue cognitive function physical function mental health
vns-induced corticospinal plasticity

Conditions: Stroke

Summary: the goal of this study is to learn more about the connections between the brain, spinal cord, and muscles and how these connections can be strengthened after neurological injury.

non-invasive stimulation techniques can be used to appropriately time converging inputs to induce changes in cortical output circuits of human primary motor cortex, a neuromodulatory protocol known as paired-associative stimulation (pas). experiments seek to examine interactions between cortical pas and non-invasive vagus nerve stimulation (vns) to understand the extent to which vns amplifies cortical plasticity in humans.

Eligibility criteria:
inclusion criteria: individuals who have had a stroke: 1. diagnosis of first ever stroke 2. at least 6 months after stroke onset 3. motor-evoked potentials in hand/arm muscles 4. subjects must show an understanding of the study goals and have the ability to follow simple directions as judged by the investigators. all individuals: 5. between the ages of 18 and 75 years old exclusion criteria: individuals who have had a stroke: 1. hemispatial neglect, aphasia, or cognitive impairment that would impact testing and would interfere with the ability to follow simple instructions, as judged by the investigators all individuals: 2. neurological disorder(s) influencing movement (besides stroke) 3. history of seizure or epilepsy 4. metallic brain implants 5. bodily implants such as cardioverter defibrillators, insulin pumps, ventriculoperitoneal shunts, cochlear implants, or pacemakers 6. pregnant or expecting to become pregnant 7. difficulty maintaining alertness and/or remaining still 8. silicone or plastic allergy 9. history of vestibular disorders (eg, vertigo, meniere's disease, etc.)

Keywords: neuromodulation paresis neurorehabilitation
family factors involved in eating disorders

Conditions: Eating Disorders

Summary: this observational study compares parental age and birth order in patients diagnosed with anorexia nervosa and bulimia nervosa.

study participants are recruited (300 patients for each entity). healthy subjects without evidence of an eating disorder serve as a control group. psychometric assessment will include data on pathological eating behavior and general psychological and interpersonal problems. outcome measures the scl-90-r questionnaire is a self-report inventory for adolescents and adults that assesses a wide range of psychological problems and symptoms of psychopathology. the questionnaire consists of 90 items, each of which contributes to one of nine primary symptom dimensions. the short form of the inventory of interpersonal problems (iip-c) is used to measure interpersonal problems. this self-report questionnaire contains 64 items assigned to eight subscales. eligible candidates are stratified as cases or matched controls as follows: 1. cases are eligible patients diagnosed with anorexia nervosa or bulimia nervosa (n=300 for each entity) at the time of study inclusion. 2. controls (100) are healthy subjects of a similar age distribution and from the same study site without the diagnosis of an eating disorder. inclusion criteria: - age \> 12 and \< 59 years (adolescents and adults). exclusion criteria: * diagnosed with a malignant disease * not fluent in the german language * severe mental disorder

Eligibility criteria:
inclusion criteria: - age \> 12 and \< 59 years (adolescents and adults) with either anorexia nervosa or bulimia nervosa. exclusion criteria: * diagnosed with a malignant disease * not fluent in the german language * severe mental disorder

Keywords: eating disorder, anorexia nervosa, bulimia nervosa
pregabalin versus celecoxib on sevoflurane and analgesic consumption in spine fixation surgery

Conditions: Post-Operative Pain

Summary: the anti-epileptic drugs such as gabapentin and other non-steroidal anti-inflammatory drugs (nsaid) such as celecoxib were used as a part of multimodal analgesia to control such pain. gabapentin is an anticonvulsant drug that has analgesic effect in post-herpetic neuralgia, diabetic neuropathy, and neuropathic pain. celecoxib is one of the nsaids, that its analgesic effect is reported in various studies by cyclooxygenase-2 (cox-2) inhibitor. the aim of this randomized double-blinded study was to asses and compare the efficacy of using gabapentin versus celecoxib as a part of multimodal analgesia in perioperative hemodynamic control and pain relief in patients underwent posterior approach lumbar spine disc fixation surgery.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) i and ii, aged between 21-60 years old scheduled to undergo elective posterior approach lumbar spine disc surgery exclusion criteria: * patients with a known sensitivity to celecoxib or pregabalin, psychotic disorder or cognitive impairment, history of drug dependency or substance addiction, history of chronic medical disease, the presence of coagulation disorders or pregnancy, were excluded from the study.
innovative tool to limit spread of covid 19 in residential aged care facilities

Conditions: COVID; Influenza; Gastroenteritis

Summary: this project is a randomised trial in order to determine if "gamification" can result in behaviour change for healthcare workers in the residential aged care setting. the app is for age care and care workers at the front line who are working to protect those most vulnerable to covid-19. there are 2 groups in this trial on group will receive current and accurate information from an app. the other group will receives the app with the addition of a gamification competent, this will include rewarding experiences for staff doing safety behaviours and wellbeing behaviours. the purpose of the gamification is to create a calming and reassuring experience that injects positivity and joy where possible during this stressful time.

the study design will be a multi- centre cluster randomised control trial, where age care facilities are randomised into two groups: 1. newsfeed- gets the app with newsfeed only 2. gamification group- gets the full gamified app, including the newsfeed workers in our network of residential aged care facilities will be invited to participate in a study of communication of information regarding covid-19 and how they will play a role in preventing its spread.

Eligibility criteria:
inclusion criteria: * age health care worker exclusion criteria: -

Keywords: infection control
perioperative treatment with tranexamic acid in melanoma

Conditions: Melanoma

Summary: surgery is a key element in the treatment of melanoma, and naturally linked with an inflammatory response and recruitment of innate immune cells. although surgery has a favorable intent, surgery-induced inflammation, neutrophils in particular, may accelerate growth of local and systemic micrometastases. thus, improving cancer surgery and modulating the wound microenvironment in ways that benefit the patients is crucial. repurposing already approved drugs in a cancer setting has gained increasing interest in recent years. interestingly, tranexamic acid was recently suggested as an anti-cancer drug, capable of reducing tumor growth in experimental animal models and reducing the viability of different melanoma cell lines. as a novel approach, sponsor and investigators will conduct a randomised clinical trial, using perioperative treatment with tranexamic acid, aiming to prevent the early relapses for patients with melanoma.

the objective of the proposed clinical trial is to test if perioperative treatment with tranexamic acid (txa) reduces the early relapses and postoperative complications for patients with melanoma and evaluate perioperative inflammation and the prognostic- and treatment-related impact of the plasminogen-plasmin pathway from human blood- and tissue samples. primary aim: to test if perioperative treatment with txa is superior to placebo and reduces the early relapse rates, from 37% to 26%, for patients diagnosed with melanoma undergoing sentinel lymph node biopsy surgery. secondary aims: 1. evaluate safety and tolerability: defined as mild (abdominal pain, diarrhea, or nausea) or severe (thromboembolic events) adverse effects. 2. evaluate postoperative complications: defined as bleeding, seroma formation, and infections within the first three postoperative months. 3. estimate melanoma-specific survival probabilities and compare the two treatment groups. explorative: from blood- and tissue samples, baseline and perioperative changes of factors associated with inflammation, fibrinolysis, metabolism, immune cell composition, and activation status will be monitored and factors will be associated with prognostic and treatment-related outcomes.

Eligibility criteria:
inclusion criteria: patients * diagnosed with invasive cutaneous melanoma (pathological stage/tumor grade ≥t2b), defined as either: breslow thickness \>1.0-2.0 mm with presence of ulceration or breslow thickness \>2.0 mm regardless of ulceration status. * eligible for surgery (wide local excision and sentinel lymph node biopsy). * \>/=18 years of age and \</=80 years of age * signed informed consent form exclusion criteria: patients * with a prior history of invasive melanoma * thromboembolic events within the last 3 months * pregnancy * active breastfeeding * known allergy or hypersensitivity to txa * known and treated epilepsia or previous seizures * egfr 0-50 * current use of tranexamic acid

Keywords: melanoma tranexamic acid relapse cancer drug repositioning surgery
generating evidence in ecmo ventilation strategies

Conditions: ARDS; Acute Respiratory Failure

Summary: the goal of this pilot clinical trial is to test if icu level ventilator protocols are appropriate interventions to study differences in ventilator strategies for patients with acute respiratory failure supported by vv-ecmo. the main questions it aims to answer are: * will clinicians closely follow different icu ventilator protocols * will different icu ventilator protocols change the way that patients are treated. participants will be assigned to one of two ventilator protocols based on the month that they are first started on ecmo. researchers will compare standard lung-protective ventilation to ultra-lung protective ventilation protocols to see how this changes how the ventilator is set for patients.

this is a pilot, open label, pragmatic cluster-crossover clinical trial testing the feasibility and exploring the clinical impact of icu-level ventilator management protocols as interventions in patients with acute respiratory failure requiring support with extracorporeal membrane oxygenation (ecmo). the overall objective is to inform the design of a future pragmatic, cluster-randomized clinical trial. the investigators will do this by completion of the following aims: aim 1: measure clinician fidelity to icu-level ventilator management protocols for patients with ards treated with ecmo. hypothesis: clinicians will have high fidelity to icu-level ventilator management protocols for patients with severe ards on ecmo. to test this hypothesis, the investigators will conduct a pilot cluster-crossover study. the duke medical icu will be treated as a single cluster of patients. this cluster will be assigned to a standard lung-protective ventilation protocol for patients treated with ecmo, and then crossover to an ultra-lung protective ventilation protocol. the investigators will record if patient ventilator settings adhere to the assigned protocol at the time of treatment. the proportion of patients whose ventilator settings adhere to the assigned protocol will be compared to an a priori defined threshold to indicate feasibility. aim 2: explore the clinical impact of using different ventilator management protocols for patients with ards treated with ecmo. hypothesis: patients managed with standard lung protective ventilation will have shorter durations of ecmo and mechanical ventilation when compared with patients managed with ultra-lung protective ventilation. to test this hypothesis, the investigators will measure the duration of ecmo and mechanical ventilation for all patients enrolled in the study. the investigators will perform an exploratory analysis examining differences in these outcomes between the two treatment groups.

Eligibility criteria:
inclusion criteria: * all patients being treated with ecmo in the duke university hospital medical icu will be eligible exclusion criteria: * there are no exclusion criteria

Keywords: extracorporeal membrane oxygenation mechanical ventilation lung protective ventilation ultra-lung protective ventilation
aramis: actions of tesaglitazar on fat metabolism and insulin sensitivity

Conditions: Type 2 Diabetes

Summary: this is a 16-week randomized, double-blind, parallel-group, multi-center, placebo- and active- (metformin 1.5 g) controlled study of tesaglitazar (1 mg) in patients with type 2 diabetes. after a 1-week enrollment period, a 3 week placebo single blind run in period and 1-week placebo single-blind baseline measurement period, the patients will be given the investigational product for 16 weeks in a double blind fashion. metformin will be titrated up during the first 3 weeks of the double-blind period. the total study duration, including enrollment, run-in, randomized treatment and follow-up, is 29 weeks.


Eligibility criteria:
inclusion criteria: * provision of a written informed consent * men or women who are 30-70 years of age * female patients: postmenopausal, hysterectomized * diagnosed with type 2 diabetes * treated with diet alone or treatment with a single oral antidiabetic agent or low doses of two oral antidiabetic agents exclusion criteria: * type 1 diabetes * new york heart association heart failure class iii or iv * treatment with chronic insulin * history of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like actos or avandia), fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme a reductase inhibitor (statin) * history of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells) * creatinine levels above twice the normal range * creatine kinase above 3 times the upper limit of normal * received any investigational product in other clinical studies within 12 weeks * any clinically significant abnormality identified on physical examination, laboratory tests or electrocardiogram, which in the judgment of the investigator would compromise the patient's safety or successful participation in the clinical study
spinejack® versus conservative treatment study (spico study)

Conditions: Spinal Fractures; Vertebral Compression Fractures; Back Injuries; Trauma

Summary: this study will compare two standard treatments in acute stable traumatic vertebral fractures (types a1 and a3.1 by magerl classification). the two treatments are as follows: 1. spinejack® system 2. conservative orthopedic management consisting of brace and pain medication.

100 subjects (18 to 60 years old) will be enrolled (1:1) with one to two painful traumatic fractures, non-pathological (types a1 and a3.1 by magerl classification). subjects will be followed at admission, procedure, discharge, 1 month, 3 months, 12 months and 24 months post vertebral compression fracture (vcf) reduction procedure or the set-up of the brace. the estimated enrollment period is 12 months and each patient should perform a 24 months follow-up period. therefore, the total study duration is estimated to be 36 months for the complete study.

Eligibility criteria:
inclusion criteria: 1. patient must have signed the consent form 2. male or female between 18 and 60 years old 3. one to two painful traumatic fractures, non-pathological, traumatic vertebral fracture is less than 10 days, between t11 and l5, type a1 and a3.1 according to magerl classification. all the fractures should meet the inclusion criteria (deformity, etiology, technical possibility of performing the procedure). 4. vertebral kyphosis angle \>10° 5. patient is eligible to treatment with brace 6. technical feasibility of a spinejack® procedure and brace 1 to 5 days after screening/baseline exclusion criteria: 1. vertebral fracture more than 10 days old 2. spontaneous osteoporotic vertebral fracture 3. neurological signs or symptoms related to the vertebral fracture 4. vertebral kyphosis angle \>30° 5. active systemic or local infection at baseline 6. patient with substance abuse 7. history of intolerance or allergic reaction to titanium or acrylic compounds 8. fracture geometry making the insertion of the implant impossible 9. malignant lesions 10. any other medical illness or condition that, in the investigator's opinion, is likely to impair long-term follow-up (e.g., cancer) or greatly increase the risk of surgery\* 11. patient on long-term steroid therapy (steroid dose ≥ 30 mg /day for \> 3 months) 12. patient presenting with a non-correctable spontaneous or therapeutic coagulation disorder. 13. non-compliant patient: impossibility to participate in the study and to be followed-up for 2 years. 14. participating in any other investigational study 15. female patients who are pregnant, breastfeeding, or planning to get pregnant during the course of the study 16. patient not affiliated to social security \*: including but not limited to patients with contraindications for general anesthesia (surgeon expertise)
current management of gastrointestinal stromal tumors (gist) in the region of coquimbo

Conditions: Gastrointestinal Stromal Tumors

Summary: this is a retrospective analysis and description of the preferred diagnostic and treatment methods employed on gist on the region of coquimbo from 2003 to 2008.


Eligibility criteria:
inclusion criteria: * all operated patients with gist * positive immunohistochemistry exclusion criteria: * patients with gist not operated * patients with gist operated on but without immunohistochemistry

Keywords: gist