Kornimate/medical-research-clean huggingface dataset:
ng004 in spinal cord injury patients

Conditions: Acute Spinal Cord Injury (SCI); Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Injuries (SCI); Wounds and Injuries

Summary: this is the fih, multicenter, open-label, sequential, multiple ascending dose trial of ng004 in patients with acute incomplete cervical sci. the trial will evaluate the safety, tolerability, and pk of 4 dose regimens of ng004, and will evaluate the maximum tolerated dose of ng004.


Eligibility criteria:
inclusion criteria: * acute incomplete cervical sci (neurological level of injury c1 ≤ lesion ≤ c8) with confirmed classification of american spinal injury association (asia) impairment scale (ais) c-d at screening * 4-28 days post-injury * no required mechanical ventilation or patients that not completely depend on mechanical ventilation * hemodynamically and clinical stable patient according to the acute sci condition at baseline exclusion criteria: * trauma caused by ballistic or other injury that directly penetrates the spinal cord including gunshot and knife wounds * multiple levels of clinically relevant spinal cord lesions * major brachial or lumbar plexus damage/trauma * significant head trauma or other injury that was, in the opinion of the investigator, sufficient to interfere with the assessment of the spinal cord function * other significant pre-existing or current severe systemic disease such as lung, liver (exception: history of uncomplicated hepatitis a), gastrointestinal, cardiac, immunodeficiency (including anamnestic known hiv) or kidney disease; or active malignancy * history of or an acute episode of multiple sclerosis or guillain-barre syndrome history of recent (6 months) meningitis or meningoencephalitis * history of refractory epilepsy * history of or current autoimmune disease * patients with uncontrolled bleeding diathesis and/or who require concomitant therapeutic anticoagulation and not related to sci * presence of any unstable medical or psychiatric condition * drug dependence any time during the 6 month's preceding trial entry * pregnant or nursing women * history of a life-threatening allergic or immune mediated reaction * patients with the presence of infection around the location where the spinal needle insertions are planned for applying the intrathecal injections * participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations * patients who are unconscious

Keywords: acute spinal cord injury nogo-a sprout regeneration
electrical impedance myography of neck and low back pain

Conditions: Low Back Pain; Neck Pain

Summary: the purpose of this study is to assess neck and low back pain using electrical impedance myography (eim) in order to develop an algorithm to aid primary care providers (pcps) in the diagnosis of neck/back pain. secondary goals include the refinement of eim technology and associated software of ease-of-use and interpretation by pcps and staff.


Eligibility criteria:
1. radiculopathy subjects: inclusion criteria: * age 21-80 years old * history consistent with radiculopathy based on clinical, radiologic, and standard electrophysiological criteria, as determined by spine expert (dr. john keel) exclusion criteria: * age under 21 or over 80 * history of a generalized neuromuscular condition, except for mild polyneuropathy or common mononeuropathies (e.g., carpal tunnel syndrome, ulnar neuropathy at the elbow) * history of moderate-to-severe ongoing medical conditions producing generalized disability, such as advanced cardiac or renal disease * metal spine implants of any type 2. musculoskeletal back pain subjects: inclusion criteria: * age 21 to 80 years old * low back or neck pain without evidence to suggest neuropathic component; i.e., without radiation of pain, sensory loss or weakness exclusion criteria: * age under 21 or over 80 * history of sciatica or cervical radiculopathy * history of a generalized neuromuscular condition, except for mild polyneuropathy or common mononeuropathies (e.g., carpal tunnel syndrome, ulnar neuropathy at the elbow) * history of moderate-to-severe ongoing medical conditions producing generalized disability, such as advanced cardiac or renal disease * metal spine implants of any type 3. undiagnosed lower back or neck pain subjects: inclusion criteria: * age 21 to 80 years old * major complaint of lower back or neck pain exclusion criteria: * age under 21 or over 80 * recent (\<6 month) history of similar symptoms that has been evaluated * history of a generalized neuromuscular condition, except for mild polyneuropathy or common mononeuropathies (e.g., carpal tunnel syndrome, ulnar neuropathy at the elbow) * history of moderate-to-severe ongoing medical conditions producing generalized disability, such as advanced cardiac or renal disease * metal spine implants of any type

Keywords: eim
study to evaluate the safety and efficacy of pradaxar for the prevention of venous thromboembolism in the mexican population undergoing elective total hip or knee replacement surgery

Conditions: Thromboembolism; Arthroplasty, Replacement, Hip

Summary: open, prospective, uncontrolled, observational cohort study.


Eligibility criteria:
inclusion criteria: * patients age 18 years or above undergoing elective total hip or knee replacement surgery * written informed consent obtained for data collection and source data verification. exclusion criteria: according to the approved label the following patients should not be treated with pradaxar® 220mg q.d.: * age of \> 75 years * renal impairment (creatinine clearance \<50ml/min) * patients on concomitant therapy with amiodarone or verapamil. * elevated liver enzymes \>2 upper limit of normal (uln) and / or hepatic impairment or liver disease expected to have any impact on survival * anaesthesia with post-operative indwelling epidural catheters * hypersensitivity to dabigatran etexilate or to any of the excipients * active clinically significant bleeding * organic lesion at risk of bleeding * spontaneous or pharmacological impairment of haemostasis except for the above-included patients groups * concomitant treatment with quinidine
therapy dog visits for patients hospitalized with traumatic injuries

Conditions: Trauma Injury; Depression; Anxiety; Anger; Pain

Summary: animal assisted therapy (aat) with dogs has been shown to be beneficial for a wide range of patients with both acute and chronic illnesses, including spinal cord injuries, heart failure, myocardial infarctions, strokes, cancer, post-traumatic stress disorder, and depression. studies have also demonstrated that even in healthy adults, the presence of dogs is associated with physiologic changes such as increased pain threshold, decreased blood pressure, and decreased heart rate. however, few studies have investigated the role of aat in the post-operative course in adults. this study will investigate the impact of therapy dog visits on pain and anxiety scores for trauma patients at boston medical center (bmc).

this study will be a randomized control design. within 48 hours of admission, the study team will approach eligible patients admitted to the inpatient trauma service to discuss the study and obtain informed consent from patients expected to be admitted for 3-7 days. consenting patients will be randomized to either a) participate in 2-3 ten-minute dog visits or b) receive 2-3 ten-minute visits with a handler alone. within 24 hours after the last anticipated study visit, a member of the study team will administer a survey to assess participants' pain, depression, anxiety, mood, and emotional quality of life.

Eligibility criteria:
inclusion criteria: * patients admitted to the trauma and acute care surgery (tacs) service following a trauma * english or spanish speaking * able to provide informed consent exclusion criteria: * fear of dogs, allergy to dogs * immunocompromised * contact precautions * delirious, intubated, or otherwise unable to consent

Keywords: therapy dogs healing pups animal assisted therapy (aat) traumatic injuries recovery
pulmonary vein isolation in typical atrial flutter and heart failure

Conditions: Atrial Flutter Typical; Heart Failure

Summary: this study, called the pvi-afl-hf trial, investigates two treatments for patients with typical atrial flutter (afl) and heart failure (hf). it aims to determine whether adding prophylactic pulmonary vein isolation (cpvi) to the standard cavo-tricuspid isthmus (cti) ablation improves long-term outcomes compared to cti ablation alone.


Eligibility criteria:
inclusion criteria: * aged 18 to 80 years * typical afl referring for ablation * no prior history of af * fulfilling the criteria for hf: new york heart association (nyha) function class ii or greater; and n-terminal pro-brain natriuretic peptide (nt-pro-bnp) \>125 pg/ml in sinus rhythm or \>365 pg/ml in afl * optimized guideline-directed medical therapy for hf for at least one month * a minimum of anticoagulation for three weeks * sign informed consent exclusion criteria: * any af episodes documented during 48-hour holter monitoring * presence of left atrial thrombus * hf due to infiltrative cardiomyopathy, constrictive pericarditis, active myocarditis, cardiac tamponade, or uncorrected primary valvular disease * acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within three months prior to enrollment * previous cardiac transplantation, complex congenital heart disease, rheumatic heart disease * untreated hypothyroidism or hyperthyroidism * dialysis-dependent terminal renal failure * life expectancy \<12 months due to non-cardiovascular causes. * any conditions that, in the opinion of the investigator, may render the patient unable to complete the study * female under pregnancy or breast-feeding * involved in other studies

Keywords: atrial flutter heart failure pulmonary vein isolation
banded versus non-banded roux-en-y gastric bypass

Conditions: Morbid Obesity

Summary: a roux-en-y gastric bypass (rygb) is on the long term not always successful in every patient because weight regain can occur. an intervention to prevent weight regain in the future is to place a silicone band (non-adjustable) around the pouch of the rygb (banded-rygb: brygb) which increases weight loss and decreases weight regain on the longer term. the question is whether primary application of a banded bypass gives a greater weight loss and / or prevent weight regain in the future versus a standard rygb.

a roux-en-y gastric bypass (rygb) is on the long term not always successful in every patient because weight regain can occur. an intervention to prevent weight regain in the future is to place a silicone band (non-adjustable) around the pouch of the rygb (banded-rygb: brygb) which increases weight loss and decreases weight regain on the longer term. the question is whether primary application of a banded bypass gives a greater weight loss and / or prevent weight regain in the future versus a standard rygb. the study design is a prospective, randomized, single center study. study population: patients who qualify for a rygb are eligible to participate. the primary rygb patients may participate if there is a bmi of 35 kg / m2 with a morbidly obesity-related comorbidity or a bmi of 40kg / m2 or higher. intervention: the standard rygb with a vertical pouch over a 40 french feeding tube with a volume of 30-50 ml, is compared with a banded-rygb (brygb)

Eligibility criteria:
inclusion criteria: * all patients who are eligible for a primary rygb exclusion criteria: * bariatric surgery in history * patients with a language barrier which may affect the compliance with medical advice * any kind of genetic disorders which can be of influence on the monitoring of medical advice * patients with a disease not related to morbid obesity, such as cushing or drug related. * chronic bowel disease for example crohn's disease or colitis colitis. * renal impairment (mdrd \<30) or hepatic dysfunction (liver function twice the normal values) * pregnancy * patients with treatment-resistant reflux symptoms. defined as reflux persistent symptoms despite the use of a minimum dose of proton-pump inhibitors
study of a prototype software to help surgical patients manage their pain medication

Conditions: Post-operative Situation

Summary: the experimental medical device is a prototype software. the device comes in the form of a smartphone with a touch interface. the smartphone used to support the software is a commercial smartphone marked ce. the study aims at assessing the feasibility of the use of this expert, patient- decision support systems. the study hypothesis is that the clinical use of the experimental device is feasible.


Eligibility criteria:
inclusion criteria: * male or female 18 years or older (no upper age limit) * operated within a surgical department of of the hautepierre university hospitals of strasbourg * patient understanding and reading french * subject neurosensorially able of interacting with a tactile electronical interface * subject able to understand research objectives, risks and provide dated and signed informed consent * subject covered by a health insurance scheme exclusion criteria: * patient with neuropsychiatric or sensory disorders that may interfere with their use of the visual interface * unable to provide informed information (subject in emergency, difficulty understanding the subject, etc.) * pregnant or lactating woman (on declaration) * patient under safeguard of justice, under guardianship, under curatorship

Keywords: prototype software patient interface experimental medical device
rivaroxaban for the treatment of symptomatic isolated distal deep vein thrombosis

Conditions: Deep Vein Thrombosis

Summary: the treatment of isolated distal deep vein thrombosis remains one of the most debated issues in the field of venous thromboembolism and only very few studies have directly addressed the issue of treatment in objectively confirmed isolated distal deep vein thrombosis. aim of this study is to assess the long-term risk of recurrent venous thrombotic events in patients with a first acute symptomatic isolated distal deep vein thrombosis of the leg treated with a standard (12 weeks) or with a shorter (6 weeks) duration of therapy with rivaroxaban.


Eligibility criteria:
inclusion criteria: * objective diagnosis of isolate distal deep vein thrombosis within 72 hours from the evaluation for inclusion in the study and if any type of parenteral treatment was administered at therapeutic doses for 3 days or less (maximum accepted doses of low molecular weight heparin: 6 doses; of fondaparinux: 3 doses). exclusion criteria: * age \< 18 years * any absolute contraindication to anticoagulant treatment * pregnancy or breast-feeding * presence of active cancer * concomitant presence of proximal deep vein thrombosis or pulmonary embolism * any concomitant indication for long-term anticoagulant treatment * creatinine clearance ≤30 ml/min, according to cockcroft-gault equation * cirrhosis child-pugh score b or c * liver disease associated with coagulopathy and high risk of bleeding * any other contraindication to rivaroxaban as per local smpc * failure to provide written informed consent
psychoeducation group intervention for fnd

Conditions: Functional Neurological Disorder

Summary: this study aims to assess the feasibility of running a brief psychoeducation group intervention in an outpatient setting to assess the practicalities and benefits of offering this type of intervention for both clinicians and patients

a functional neurological disorder (fnd) is when the brain has difficulties sending and receiving signals . as a result people can experience problems in how their body and senses work, but there is no physical problem to treat. currently there is little treatment to offer after diagnosis, this study will investigate the feasibility and potential benefit to offering a group intervention to people with fnd. this group intervention will offer chance to access information and the opportunity to meet others with the similar difficulties. eligible participants will be those currently attending neurology clinics within nhs grampian. participants will complete prior to, during and at 3 months after the group is completed. these measures include health care use of participants, reported physical symptoms, subjective quality of ife and mood we will also take a brief measure of attention and concentration. reported physical symptoms, subjective quality of life and mood will also be collected before the first group and at the last group.

Eligibility criteria:
inclusion criteria: * individuals aged between 18-64 years with a diagnosis of fnd exclusion criteria: * anyone the clinical neuropsychologist/neurologist feels, as a result of their clinical judgement, lacks capacity to consent. * people who are unable to understand the information sheet due to english not being their first language. * severe sensory impairment. * anyone experiencing active severe psychiatric symptoms * a dependency on alcohol or recreational drugs * learning disability as classified by icd 10. * those unable to travel independently to attend group sessions due to the severity of their symptoms

Keywords: fnd functional neurological disorder psychoeducation
prevention of nosocomial e. coli infections after placement of an indwelling catheter during pelvic surgery: an evaluation of cranberry gel capsules

Conditions: Cross Infection; Bacteriuria

Summary: indwelling urinary catheters are a primary site for nosocomial infections. the purpose of this study is to evaluate the anti-adhesive properties of cranberry type a pro anthocyanidine gel capsules in the prevention escherichia coli infections on indwelling urinary catheters placed in patients following pelvic surgery. the investigators primary working hypothesis is that cranberry treatment decreases e. coli colonization on indwelling urinary catheters, thus preventing nosocomial urinary infections following pelvic surgery.


Eligibility criteria:
inclusion criteria: * patient is cared for by the department of the gynecology at the nîmes unversity hospital * the patient is programmed for surgery with placement an indwelling catheter for 48 hours with a sterile urinary cytobacteriologic exam at inclusion exclusion criteria: * the urinary cytobacteriologic exam at inclusion is positive * the patient is taking antivitamin k * the patient is taking antibiotics * history of urolithiasis * the patient refuses to participate * the patient is pregnant or nursing * the patient is not associated with a social security system (no insurance) * the patient is under guardianship
phase iii randomized, double-blind, placebo-controlled study of mexiletine for painful diabetic neuropathy

Conditions: Pain; Diabetic Neuropathies; Paresthesia

Summary: objectives: i. assess the efficacy and toxicity of mexiletine in the management of paresthesias and pain in patients with diabetic neuropathy.

protocol outline: this is a randomized, double-blind study. patients are stratified by participating institution. the first group receives oral mexiletine 3 times a day for 6 weeks. the dose is increased after the first week if there are no side effects. the second group receives a placebo. patients cross to the alternate treatment after a 1-week washout.

Eligibility criteria:
patients with painful diabetic neuropathy

Keywords: diabetic neuropathy disease-related problem/condition neurologic and psychiatric disorders pain rare disease
subthreshold scs or bmt

Conditions: Failed Back Surgery Syndrome

Summary: given the substantial socioeconomic impact of spinal cord stimulation (scs) implantations and given that currently no direct high-quality evidence with a relevant outcome measurement is available to guide the treatment choice between subthreshold scs versus best medical treatment in patients with persistent spinal pain syndrome type 2 (psps-t2), we here propose a scientifically well-constructed randomized controlled trial to answer this question. the primary scientific objective is to examine whether subthreshold scs, compared to best medical treatment, provided to patients with psps-t2 results in a higher percentage of clinical holistic responders at 6 months. the secondary objective of the study is to examine if subthreshold scs compared with bmt is having more efficacy in improving patients' individual competencies for self-management, increasing the likelihood to return to work, work status and healthcare expenditure, improving pain relief, obtaining pain medication reduction, decreasing anxiety and depression, increasing quality of life and decreasing disability.

after filling in the questionnaires at the 6 months follow-up visit, patients could change treatment groups (in both directions). this decision will be a shared decisions between patient and treating physician in case the randomized intervention did not provided enough pain relief.

Eligibility criteria:
inclusion criteria: * persistent spinal pain syndrome type ii (psps-t2) * chronic pain as a result of psps-t2 that exists for at least 6 months with a pain intensity of at least 4/10 on the numeric rating scale, refractory to conservative treatment. * psps-t2 patients eligible for subthreshold scs * age \> 18 years * patient has been informed of the study procedures and has given written informed consent * patient willing to comply with study protocol including attending the study visits exclusion criteria: * expected inability of patients to receive or properly operate the spinal cord stimulation system * evidence of an active psychiatric disorder * suffering from another chronic illness characterised by chronic generalized widespread pain (e.g. rheumatoid arthritis, fibromyalgia, chronic fatigue syndrome, scleroderma). * pregnancy