Kornimate/medical-research-clean huggingface dataset:
the effect of neuropathic pain in patients with combat-related extremity injury

Conditions: Neuropathic Pain

Summary: it has been suggested that veterans with chronic pain might be at increased risk for the development of depression, anxiety and post-traumatic stress disorder. to date, most of the published studies have focused on chronic pain as a whole, and there are limited studies examining association of neuropathic pain with psychological comorbidity and quality of life.combat related extremity injury significantly influences the patients' quality of life and psychological state. in this context, the purpose of this study is to illustrate to what extent neuropathic pain influences the quality of life, depression level and sleep quality of patients with combat-related extremity injury.

a total of 120 patients with combat-related extremity injury and 60 age and bmi-matched healthy controls will be participated in this cross-sectional study. the presence of neuropathic pain will be evaluated using leeds assessment of neuropathic symptoms and signs (lanss) questionnaire. the impact of pain on health-related quality of life will be assessed using the 36-item short form survey (sf-36). beck depression scale (bds) will be used to evaluate depression status of the patients. quality of sleep will be assessed using the pittsburgh sleep quality index (psqi).

Eligibility criteria:
inclusion criteria: * patients between the ages of 18-65 years who had previous history of combat-related extremity injury exclusion criteria: * previous history of the cervical or lumbosacral radiculopathy, any known rheumatic disease or neurologic or endocrine disorders, excessive alcohol consumption and vitamin b12 deficiency
study of sgm-1019 in patients with nonalcoholic steatohepatitis (nash)

Conditions: Nonalcoholic Steatohepatitis

Summary: this is a multicenter, randomized, double-blind, placebo-controlled study evaluating the safety, pharmacokinetics, and pharmacodynamics of 12 weeks' administration of sgm-1019 in subjects with fibrosis stage 1-3 (f1-f3) nash.


Eligibility criteria:
inclusion criteria: * male or female * age 18 to 75 years, inclusive * elevated alt * f1-f3 nash * bmi ≥ 25 exclusion criteria: * use of prohibited medication/supplements * poorly controlled type 2 diabetes * hepatic decompensation * chronic liver disease * planned surgeries/procedures
an observational study of aducanumab-avwa in participants with alzheimer's disease in the us

Conditions: Alzheimers Disease

Summary: this is a prospective, single-arm, multicenter, non-interventional study of aducanumab-avwa as prescribed in the post-marketing setting in the us. investigators will be prescribing aducanumab-avwa and participants will be treated according to the standard of care (soc). participants will be followed up to 5 years after enrollment and data will be collected at routine visits every 6 to 12 months.


Eligibility criteria:
key inclusion criteria: * participant has a diagnosis of alzheimer's disease (ad) and is prescribed aducanumab-avwa by their treating physician. * participant's treating physician has made the decision to initiate aducanumab-avwa prior to participant inclusion and independently of the purpose of the study. key exclusion criteria: * participant concurrently participates in any interventional clinical study. * participant has ever been treated with aducanumab-avwa at a dose of 3 milligrams per kilogram (mg/kg) or greater prior to signing icf. * participant has ever been treated with aducanumab-avwa and discontinued treatment prior to signing icf. note: other protocol defined inclusion/exclusion criteria may apply
at-home tavns - stroke rehab

Conditions: Stroke; Stroke, Ischemic; Stroke Hemorrhagic

Summary: early evidence suggests the benefits of post-stroke motor rehabilitation may be enhanced by applying electrical stimulation to the ear. this study aims to test the new approach of pairing ear stimulation with motor rehabilitation in the home setting in stroke survivors with upper limb motor function deficits.

this study seeks to advance prior research conducted here at musc exploring the use of transcutaneous auricular vagus nerve stimulation (tavns) paired with motor rehabilitation to improve motor function post-stroke. early evidence from a recently completed nih-funded, clinical trial suggests that our new approach of delivering electrical stimulation to the ear at the same time as motor rehabilitation double the clinical benefits of motor rehabilitation. these benefits are due in part to a facilitation of neuroplasticity caused by activating the auricular branch of the vagus nerve. this project takes this approach one step further, moving it into the home in combination with telerehabilitation in order to make this technology more accessible to individuals in rural and remote areas. in order to accomplish this, investigators will a) conduct lab-based testing and validation of the stimulation triggering sensors for at-home use, and b) determine the safety, feasibility, and acceptability of at-home tavns in five stroke survivors with unilateral upper limb motor deficits. investigators hypothesize that our lab-based validation will facilitate an optimized home intervention. furthermore, investigators hypothesize tavns will be safe and feasible to self-administer in the at-home setting. lastly, investigation will help elucidate any challenges that may occur as investigators begin to expand this technology into future larger trials

Eligibility criteria:
inclusion criteria: * 18-80 years old with an ischemic or hemorrhagic stroke that occurred ≥6 months prior; * ability to give consent; * unilateral limb (left or right) weakness with fugl meyer-upper extremity scale score of 19-53/60 points which indicates adequate arm/hand use for rehabilitation tasks; * active wrist flexion/extension ≥10° with active abduction/extension of thumb and at least 1 digit ≥10° to further assure ability to participate in rehabilitation tasks; * passive range of motion in affected shoulder, elbow and wrist within 20 degrees of normal values. exclusion criteria: * other concomitant neurological disorders affecting upper extremity motor function; * presence of dysphagia or aspiration difficulties; * prior injury to vagus nerve; * pregnancy; * documented history of dementia before or after stroke; * documented history of uncontrolled depression or psychiatric disorder either before or after stroke which could affect their ability to participate in the experiment; * uncontrolled hypertension; * botox injections within 4 weeks of the first day of rehabilitation therapy.
basal insulin and compensation glycemic in diabetic patients in basal bolus outpatient.

Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: multicentric, observational, cross-sectional study in italy. the aims are to evaluate the basal/total ratio of daily insulin dose (b/t) in diabetic outpatients type 1 (t1) and type 2 (t2) on basal-bolus regimen, by investigating whether there is a relationship with hba1c and episodes of hypoglycemia.

the study was commissioned by the italian association of clinical endocrinologists (associazione medici endocrinologi - ame) and approved by the ethical committee of cuneo hospital (basal study- oss 001/2016 - rif endo 30). the research was open to all specialists taking care of patients with diabetes in italy. the primary endpoint was glycemic control, evaluated by hba1c levels, according to b/t. secondary endpoints were occurrence of major hypoglycemic episodes according to b/t; differences between patients with t1 and t2. an ad hoc form was developed and used to record all medical findings. the form was emailed to all participating centers who then emailed or faxed it back to our data manager. data were checked for accuracy. the following data were required: age, gender, body weight and height, country of origin, type of diabetes and its duration, units of basal and total (basal plus prandial) daily insulin, type of basal insulin (glargine, detemir or degludec), use and dosage of metformin, and number of major hypoglycemic episodes (\<40 mg/dl or requiring caregivers intervention) in the last three months. serum creatinine and hba1c levels obtained within the previous two months were also required. each participating center recruited between 20 and 40 diabetic outpatients. inclusion criteria were as follows: adult outpatients (≥20 and ≤80 years) with t1 or t2 diabetes mellitus, on basal-bolus insulin regimen (basal insulin, i.e. glargine, detemir or degludec, plus at least two prandial insulin shots) for at least six months, usually assuming three daily meals, and capable of informed consent.

Eligibility criteria:
inclusion criteria: * adult outpatients (≥20 and ≤80 years); * t1 or t2 diabetes mellitus; * basal-bolus insulin regimen (basal insulin, i.e. glargine, detemir or degludec, plus at least two prandial insulin shots) for at least six months; * assuming three daily meals; * capable of informed consent. exclusion criteria: * pregnancy; * breast-feeding; * severe liver or renal failure (egfr \<30 ml/min/1.73 m2); * use of oads (except for metformin); * hospitalization for any cause in the last six month; * glucocorticoid treatment in the last six month; * oncologic treatment in the last six month; * ramadan in the last six months.
the effect of a stepped-care metacognition-based intervention on managing fear of cancer recurrence

Conditions: Cancer; Fear of Cancer Recurrence

Summary: a sequential multiple-assignment randomized controlled trial (smart) will be used to assess the effect of an adaptive stepped-care intervention on fcr in cancer survivors with subclinical levels of fear of cancer recurrence.

the current smart trial aims to address the following hypotheses: hypothesis 1: it is better to begin adaptive interventions with econquerfear than with ehealthmaintenance. hypothesis 2: among initial non-respondents, it is better to switch to supervised, face-to-face conquerfear than to augment econquerfear with ehealthmaintenance. hypothesis 3: econquerfear + conquerfear will lead to the greatest reduction in fear of cancer recurrence. hypothesis 4: there would be an indirect effect of stepped-care conquerfear intervention on fear of cancer recurrence through its effect on maladaptive metacognition and cognitive attentional syndrome.

Eligibility criteria:
inclusion criteria: * cantonese- or mandarin-speaking chinese patients diagnosed with curable breast, colorectal, or gynecological cancer, who had completed treatment (except endocrine therapy) within five years, and with a fear of cancer recurrence inventory-short form (fcri-sf) score of 13 to 21 indicating subclinical fcr will be included. exclusion criteria: * patients with metastatic cancer, with a current diagnosis of depression or psychosis, or who are already receiving psychological treatment will be excluded.

Keywords: sequential multiple assessment randomized controlled trial stepped-up care psychooncology
the benefits of cryoablation in patients undergoing total knee arthroplasty

Conditions: Post-Operative Pain; Total Knee Arthroplasty

Summary: the purpose of this study is to evaluate the efficacy of cryoablation use on patient-reported outcomes (proms) and opioid consumption following total knee arthroplasty. this is a randomized study that will involve a 1:1 randomization to total knee arthroplasty +/- cryoablation.


Eligibility criteria:
inclusion criteria: * patients are candidates for elective primary total knee arthroplasty for a diagnosis of osteoarthritis or inflammatory arthritis. * patients have been medically cleared and scheduled for surgery exclusion criteria: * patients with cold-related conditions (cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, and raynaud's disease) * surgery for fracture, infection, or malignancy
a clinical study of shr-a1811 in the treatment of her2-positive locally advanced or metastatic biliary tract cancer

Conditions: HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer

Summary: this study is an open, multicenter phase ii clinical trial to evaluate the efficacy and safety of the shr-a1811 combination in her2 positive patients with locally advanced or metastatic biliary tract cancer.


Eligibility criteria:
inclusion criteria: 1. age 18-75 years old (including both ends), male or female; 2. ecog-ps score: 0 or 1; 3. expected survival ≥ 12 weeks; 4. locally advanced or metastatic biliary tract cancer confirmed by histopathology or cytology; 5. subjects who had not previously received any systemic antitumor therapy were allowed to have previously received radical therapy, and had received the last dose of radical therapy for at least 6 months until disease recurrence; 6. according to the recist v1.1 standard, the subjects had at least one measurable lesion; 7. the main organ function is normal, in line with the program requirements; 8. consent to contraception. exclusion criteria: 1. other active malignancies within 5 years or at the same time; 2. local antitumor therapy was received within 4 weeks prior to initiation of treatment; 3. subjects with biliary obstruction should be excluded; 4. there is active autoimmune disease or a history of autoimmune disease that may recur; 5. known or suspected history of interstitial pneumonia or interstitial lung disease, or prior history of interstitial pneumonia or interstitial lung disease requiring hormone therapy; 6. severe infection within 4 weeks prior to initiation of study treatment; 7. active hepatitis b virus (hbv) infection; 8. have serious cardiovascular and cerebrovascular diseases.
continuous glucose monitoring and metabolic control in children with type 1 diabetes

Conditions: Type 1 Diabetes Mellitus

Summary: the primary purpose of this pilot randomized controlled trial is to provide preliminary indicators of the effects of continuous subcutaneous insulin infusion with continuous glucose monitoring compared to self-monitoring of blood glucose alone on: (1) metabolic control and (2) fear of hypoglycemia. additional objectives will be: (1) to provide an estimate of recruitment rates, (2) to assess compliance with allocated treatment, and (3) to determine participants' satisfaction with allocated treatment. with increased and immediate information related to current and future (trend) glucose information provided by the continuous glucose monitor, children can then act upon this knowledge to prevent hypo- or hyperglycemia, thus, experiencing a reduction in glucose variability, leading to an improvement in metabolic control as shown by a reduction in hba1c levels. research on the effectiveness of continuous glucose monitoring on metabolic control in children with t1d using continuous subcutaneous insulin infusion has been limited. therefore, a pilot clinical trial will be designed to provide preliminary indicators of the feasibility and acceptability of continuous glucose monitoring on metabolic control and address the following objectives.


Eligibility criteria:
inclusion criteria: * children aged 6-18 years * t1d for greater than one year; * willing to perform at least three self-monitoring blood glucose tests per day; * has been using continuous subcutaneous insulin infusion for more than one month * english speaking exclusion criteria: * presence of celiac disease (can cause malabsorption of nutrients affecting metabolic control) * use of corticosteroids that have systemic effects and affect glucose levels * currently using continuous glucose monitoring * cognitively unable to self-manage, based on parent's and/or care provider's opinion
vaginal vault prolapse surgical treatment

Conditions: Vaginal Vault Prolapse; Pelvic Floor Prolapse

Summary: since apical support is the mainstay of vaginal cuff restoration, sacrocolpopexy is still accepted as the gold standard technique in vaginal vault prolapse (vvp). the increased risk of surgical morbidity in the abdominal approach has prompted the interest in minimally invasive surgery. laparoscopic lateral suspension (lls) using mesh is an efficient alternative technique for apical support. in addition, vaginal approaches have been used in cuff prolapsus surgery for many years. uterosacral ligaments are strong native tissues used in cuff surgery and apical support. in recent years, vaginal natural orifice transluminal endoscopic surgery (vnotes) has offered advantages particularly complications related to the ureter over the traditional transvaginal uterosacral ligament suspension in cuff restoration.

hysterectomy is one of the common surgical procedures in current gynecology practice and is a risk factor for vault prolapse. since apical support is the mainstay of vaginal cuff restoration, sacrocolpopexy is still accepted as the gold standard technique in vaginal vault prolapse (vvp). the increased risk of surgical morbidity in the abdominal approach has prompted the interest in minimally invasive surgery. laparoscopic lateral suspension (lls) using mesh is an efficient alternative technique for apical support. in addition, vaginal approaches have been used in cuff prolapsus surgery for many years. uterosacral ligaments are strong native tissues used in cuff surgery and apical support. in recent years, vaginal natural orifice transluminal endoscopic surgery (vnotes) has offered advantages particularly complications related to the ureter over the traditional transvaginal uterosacral ligament suspension in cuff restoration. lack of incision pain, better cosmetic results, and direct visualization of important structures such as the rectum and ureter that cannot be obtained with the traditional transvaginal approach are important advantages of vnotes approach.

Eligibility criteria:
inclusion criteria: * women with vaginal vault prolapse exclusion criteria: * women who have previously undergone surgical treatment for pelvic organ prolapse * women who needed additional surgery due to anterior or posterior prolapse or stress incontinence * pelvic inflammatory disease * suspected gynecological malignancy * rectovaginal endometriosis * obliterated rectovaginal space detected on pelvic examination.

Keywords: vaginal vault prolapse vnotes high uterosacral ligament suspension lateral suspension laparoscopy
virtual reality cognitive-affective training for opioid use disorder- a phase 2 rct

Conditions: Opioid Use Disorder

Summary: the goal of this clinical trial is to examine the usefulness of a virtual reality-delivered intervention for individuals with opioid use disorder who are taking medication. the main question it aims to answer is will people with opioid use disorder who receive the study intervention, mindfulness-oriented recovery enhancement in virtual reality (more-vr), have fewer days in which they use opioids than will people who just receive their usual treatment. participants will be randomly assigned to either receive 8 weekly sessions of more-vr in addition to their usual treatment, or treatment as usual only. researchers will compare these groups at the end of treatment and three months after treatment is over on number of days of opioid use and time until first opioid use lapse, as well as drug craving and mood.

this project is a phase ii, two-arm, parallel randomized controlled trial (rct) of a virtual reality form of mindfulness-oriented recovery enhancement (more-vr) versus treatment as usual (tau) for patients receiving medications for opioid use disorder (moud) to assess the efficacy of the more-vr system. participants will be randomized (1:1) to either 8 weekly sessions of more-vr or tau. participants will be assessed at intake, post-treatment, and a 3 month post-treatment follow-up. the primary outcome assessed will be days of opioid use.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * current dsm-5 oud diagnosis * prescribed medications for opioid use disorder (e.g., buprenorphine, methadone) exclusion criteria: * completion of a standardized mindfulness intervention (e.g., more, mbrp, mbsr) * active psychosis or suicidality * reports, or is noted by clinical or study staff as showing cognitive impairment * condition which might be contraindicated for vr use including seizure disorder, vertigo, severe motion sickness, recent concussion

Keywords: mindfulness virtual reality opioid use disorder
home-based leg heat therapy

Conditions: Peripheral Arterial Disease

Summary: the objective of this study is to evaluate the benefits of participating for 8 weeks in a home-based daily treatment with heat therapy (ht) or a thermoneutral control intervention, as assessed by vascular function, walking tolerance and quality of life.

heat therapy (ht) is an emerging non-invasive approach that has been shown to enhance vascular function of the leg in old individuals. the objective of this randomized, controlled study is to evaluate the benefits of participating for 8 weeks in a home-based daily treatment with heat therapy (ht) or a thermoneutral control intervention, as assessed by vascular function, walking tolerance and quality of life. the central hypothesis of this study, based on preliminary data, is that exposure to ht will enhance the oxygenation of calf muscles during exercise and as a result, the onset of pain will be delayed and walking performance will be enhanced. the duration (8 weeks) was chosen based on the recent report of brunt and co-workers that the improvement in endothelial function promoted by repeat ht in sedentary individuals peaks at 8 weeks following the onset of treatment. heat therapy will be applied daily for 90 minutes using water-circulating 'pants' connected to a water pump. outcomes will be assessed at the halfway point (end of week 4), at the completion of the intervention (end of week 8) and 4 weeks after the end of the intervention (week 12).

Eligibility criteria:
inclusion criteria: * men and women with a stable symptomatic pad for ≥6 months * ankle brachial index \<0.9 in at least one leg * age between 40 and 80 years exclusion criteria: * uncontrolled diabetes (hba1c \> 8.5 measured within 3 months prior to date of consent) * wheelchair bound * use of a walking aid (i.e. cane, crutches, walker, motorized chair) * critical limb ischemia (ischemic rest pain or ischemia-related non healing wounds or tissue loss * impaired thermal sensation in the legs * exercise-limiting comorbidity * chronic heart failure stages c and stage d (stage c: structural heart disease is present and symptoms have occurred; stage d: presence of advanced heart disease with continued heart failure symptoms requiring aggressive medical therapy) * morbid obesity bmi \> 35 or unable to fit into water-circulating pants * open wounds or ulcers on the extremity * prior amputation * lower extremity revascularization, major orthopedic surgery, cardiovascular event, or coronary revascularization in the previous three months * planned revascularization or major surgery during the next six months * plans to change medical therapy during the duration of the study * active treatment for cancer * chronic kidney disease (egfr \<30 by mdrd or mayo or cockcroft-gault formula). * hiv positive, active hbv or hcv disease. * presence of any clinical condition that makes the patient not suitable to participate in the trial. * unable to walk on the treadmill