Kornimate/medical-research-clean huggingface dataset:
a phase iii trial of e-tns for the acute treatment of migraine

Conditions: Migraine

Summary: the main objective of this study is to have phase iii evidences of the efficacy of the cefaly® abortive program device used at home for 2 hours to treat a migraine attack. this randomized, double-blind, sham-controlled trial will study the abortive treatment of migraine using the cefaly® abortive program device.

the main objective of this study is to have phase iii evidences of the efficacy of the cefaly® abortive program device used at home for 2 hours to treat a migraine attack, as triptans are generally used. that is to say having randomized, double-blind, sham-controlled data of the efficacy and safety of the cefaly® abortive program device in the abortive treatment of acute migraine as measured by 2-hour pain freedom, pain relief and migraine-associated symptoms freedom, plus evolution of these measurements for 24 hours after the beginning of the treatment session.

Eligibility criteria:
inclusion criteria: 1. age from 18 to 65 on the day of signing the informed consent form 2. ≥ 1-year history of migraine with or without aura according to the diagnostic criteria listed in international classification of headache disorders (ichd)-3 beta (2013) section 1, migraine, with the exception of aura without headache, hemiplegic migraine and brainstem aura migraine 3. migraine onset before the age of 50 4. having between 2 and 8 moderate or severe migraine attacks (grade 2 or 3) per month in each of the two months prior to screening 5. patient understands the study procedures, alternative treatments available, and voluntarily agrees to participate in the study by giving written informed consent 6. patient is able to read and understand the written information (instruction sheet, paper diary and adverse events reporting form) exclusion criteria: 1. patient has difficulty distinguishing his/her migraine attacks from tension-type headaches 2. patient has more than 15 headache days per month 3. patient having received supraorbital nerve blocks in the prior 4 months 4. patient having received botox treatment in the prior 4 months 5. modification of a migraine prophylaxis treatment in the previous 3 months 6. diagnosis of other primary headache disorders, except rare (\< 4) tension-type headaches per month 7. diagnosis of secondary headache disorders including medication overuse headache (moh) 8. patient abusing opioids or user of recreational or illicit drugs or having had a recent history (within the last year) of drug or alcohol abuse or dependence 9. implanted metallic or electronic device in the head 10. cardiac pacemaker or implanted or wearable defibrillator 11. patient having had a previous experience with the cefaly® device 12. migraine aura without headache 13. patient is currently participating or has participated in a study with an investigational compound or device in the last 30 days before the screening visit (visit 1) 14. patient not having the ability to use appropriately the device and/or to perform himself/herself or bear the first 20-minute stimulation session during the training test session at the study site
iact for eating disorders in type 1 diabetes

Conditions: Type 1 Diabetes; Eating Disorders

Summary: this project is a randomized controlled trial of iact, a novel mhealth intervention for eating disorders in type 1 diabetes (ed-t1dm). participants will be 128 t1dm patients between the ages of 16-45 with binge-purge eds, including threshold and subthreshold bulimia nervosa, binge eating disorder and purging disorder. participants will be randomized to either iact or usual care, and complete assessments at baseline and every 3 months for 9 months. the primary outcome of interest is glycemic control as assessed by continuous glucose monitoring. other outcomes include hba1c, eating disorder symptoms, diabetes self-management and diabetes distress. in addition to examining clinical outcomes, this study tests biobehavioral mechanisms of change and predictors of treatment response. process of change assessments focus on flexible responding to pathology-relevant stimuli and early improvement in glycemic control affecting executive function. the primary site is duke university medical center. the miriam hospital is a secondary site.


Eligibility criteria:
inclusion criteria: * 16-50 years of age * diagnosis of type 1 diabetes * eating disorder characterized by binge eating and/or problematic weight control behaviors, including withholding insulin (bulimia nervosa, binge eating and purging disorder spectrum diagnoses) * independently manages diabetes (not reliant on a caregiver) exclusion criteria: * current suicidal ideation or self-harming behavior * diagnosis of avoidant restrictive food intake disorder or anorexia nervosa spectrum diagnoses * hypoglycemic unawareness as assessed by the gold method * current substance abuse disorder or current or past psychotic disorder * nonenglish speaking
efficacy of education via phone-based text messaging (sms) on patients with uncontrolled hypertension

Conditions: Hypertension

Summary: uncontrolled hypertension (htn) is a major public health worldwide, which increases the risk of cardiovascular diseases. low adherence to medication, unhealthy lifestyle and poor knowledge of htn diagnosis and treatment are among the known factors associated with uncontrolled htn. digital innovations became popular as low-cost tools to provide personalized advice to people with long-term health conditions, leading to their adherence to health behavior modifications. therefore, this randomized single-blind controlled trial (rct) aimed to test whether providing health information via a short message service (sms) influences blood pressure control, health practice, and medication adherence. for the current rct, the investigators will use data from the persian kavar cohort study (pkcs). eligible participants with uncontrolled htn will be randomly assigned to experiment (sms) or control (routine care) groups at a 1:1 ratio. participants in the experimental group will receive three messages/per week for three months. systolic and diastolic blood pressure will be the primary outcomes of this study. medication adherence and practice related to cardiovascular diseases will the secondary outcomes. these variables will be assessed before and after the intervention. at the end of the study, the acceptability of the messages will also be assessed.


Eligibility criteria:
inclusion criteria: * patients who have a diagnosis of htn by a clinician at the baseline or until the third follow-up of pkcs, have uncontrolled htn (≥140/90) at the enrollment, have a prescription for blood pressure-lowering medication, understand persian, have regular access to a mobile phone, and are able to read sms by themselves or with their family's help. the investigators will enroll only one member per household. exclusion criteria: * those with renal failure or requiring specialist care for their hypertension at a hospital, pregnant women or who are within 3 months postpartum, patients with severe physical or mental illness, and subjects not willing to participate in the study.
can-prime: precise robotically implanted brain-computer interface for the control of external devices

Conditions: Tetraplegia/Tetraparesis; Quadriplegia; Quadriplegia/Tetraplegia; Cervical Spinal Cord Injury; Amyotrophic Lateral Sclerosis (ALS); Spinal Cord Injury (Quadraplegia); Spinal Cord Injury

Summary: the can-prime study is to test the safety and functionality of neuralink's n1 implant and r1 robot in people who have difficulty moving their arms and legs (tetraparesis or tetraplegia). the n1 implant is a small, wireless device placed in the skull. it connects to tiny threads inserted into the brain by the r1 robot, which is a machine designed to carefully place these threads. this study will help researchers learn how well the implant and robot work and if they are safe for use.


Eligibility criteria:
inclusion criteria: * severe quadriplegia (tetraplegia) due to spinal cord injury or amyotrophic lateral sclerosis (als) for at least 1 year without improvement, where quadriplegia is defined as having very limited or no hand, wrist, and arm movement and all levels below * life expectancy ≥ 12 months. * ability to communicate in english * presence of a stable caregiver exclusion criteria: * moderate to high risk for serious perioperative adverse events * active implanted devices * morbid obesity (body mass index \> 40) * history of poorly controlled seizures or epilepsy * history of poorly controlled diabetes * requires magnetic resonance imaging (mri) for any ongoing medical conditions * acquired or hereditary immunosuppression * use of smoking tobacco or other tobacco products * psychiatric or psychological disorder * brain mri demonstrating hemorrhage, tumor, distorted or adverse anatomy. * any condition which, in the opinion of the investigator, would compromise your ability to safely participate in the study or undergo the implantation procedure

Keywords: brain computer interface neuralink n1 implant neuralink robot tetraparesis tetraplegia quadriplegia als spinal cord injury amyotrophic lateral sclerosis chip brain chip external device control wireless implant neuroprosthetics sci paralysis
moderna covid-19 vaccine mrna-1273 observational pregnancy outcome study

Conditions: SARS-CoV-2

Summary: the main goal of this study is to evaluate the outcomes of pregnancy in females exposed to the moderna covid-19 vaccine (mrna-1273) during pregnancy.

the moderna covid-19 vaccine pregnancy registry will collect and analyze information on the potential impact of exposure to the moderna covid-19 vaccine on pregnancy and birth outcomes.

Eligibility criteria:
inclusion criteria: * currently pregnant * the outcome of pregnancy (that is, pregnancy loss or live birth) must not be known at entry. * agrees to electronically sign the release of medical information form permitting the study to contact her hcps (for example, primary care provider \[pcp\], obstetrician, nurse midwife) and the infant's hcp (for example, pediatrician) for medical information. * received the moderna covid-19 vaccine at any point from 28 days prior to last menstrual period (lmp) throughout pregnancy. exclusion criteria: * participant has received any other covid-19 vaccines at any point from 28 days prior to lmp throughout pregnancy. * women currently participating in another investigational device or drug study, currently taking an investigational medicinal product, or having taken an investigational product within 28 days prior to lmp or during pregnancy.

Keywords: mrna-1273 mrna-1273 vaccine sars-cov-2 sars-cov-2 vaccine coronavirus virus diseases messenger rna covid-19 covid-19 vaccine moderna
impact of mulberry leaf on type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to evaluate whether mulberry leaf extract will help control blood sugar in patients with type 2 diabetes. we also want to look at the safety of mulberry leaf extract in these patients.

the methods for testing this hypothesis include: a 2-week placebo run-in, followed by a double-blind randomization into 2 groups: (1) mulberry leaf extract and (2) matching placebo. evaluations of hemoglobin a1c (a1c) -- a measurement of blood glucose over the past 3 months -- will be done at baseline \[before placebo run-in period\] and 3 months. evaluations of safety laboratories and adverse effect questionnaire will be done at 4 weeks and at 3 months following the randomization visit. subjects will undergo a 2-week placebo run-in phase, and then will be divided into two groups: (1) mulberry leaf extract and (2) matching placebo. the subjects will ingest 1000 mg (#2 500 mg capsules) of standardized mulberry leaf extract (nature-gen, san diego, ca) or matching placebo three times daily with meals for 3 months. patients will be asked to monitor fasting morning blood glucose and 2-hour postprandial dinner blood glucose daily during the 2-week placebo run-in. to ensure compliance, only subjects compliant with both medication and monitoring instructions will be issued a 30-day supply of study medication at enrollment and the remainder at the 4-week safety visit. each visit will consist of clinical examination, completed questionnaires, evaluation of self-monitoring blood glucose (smbg), and donated blood for clinical laboratory tests. standard recommendations for therapeutic lifestyle intervention will be given to both groups. all the clinical laboratory tests will be performed at the university of mississippi medical center. all patients will receive identical 2-week placebo phase capsules, and then be randomized to each group using similar lookin

Eligibility criteria:
inclusion criteria: * type 2 diabetes * no diabetes medication adjustments for at least 2 months * stable hemoglobin a1c \[between 7.0% to 8.0% (inclusive) and not varying by more than 10% since prior visit; if no a1c exists prior to the current visit and no medication adjustments are made, the current a1c may used as the baseline\] exclusion criteria: * on insulin * history of overt cardiovascular disease * history of missed appointments or non-compliance with medications * history of hepatic or renal insufficiency * history of hemoglobinopathies * women of reproductive potential not on oral contraceptives * pregnant/nursing women.

Keywords: herbal supplement type 2 diabetes mulberry hemoglobin a1c
evaluate sage-547 in female participants with severe postpartum depression

Conditions: Postpartum Depression

Summary: this is an open-label proof-of-concept study designed to evaluate the safety, tolerability, pharmacokinetics (pk), and efficacy of sage-547 injection in adult female participants diagnosed with severe postpartum depression (ppd).


Eligibility criteria:
inclusion criteria: * adult females, 18-45 years old who experienced a major depressive episode in the postpartum period beginning within the first 4 weeks following delivery * participant has ceased lactating, or if still lactating has already fully and permanently weaned their infant; if still actively breastfeeding, participant must agree to cease giving breast milk to their infant prior to study entry exclusion criteria: * recent history or active clinically significant manifestations of metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, musculoskeletal, dermatological, urogenital, or eyes, ears, or nose and throat (eent) disorders * active psychosis * medical history of seizures

Keywords: postpartum depression
preoperative antibiotic dosing for total knee arthroplasty

Conditions: Acute Infection of Total Knee Replacement

Summary: to directly compare acute infection rates in patients undergoing total knee replacement with intraosseous regional administration or systemic intravenous administration of prophylactic antibiotics.

subjects will be prospectively enrolled into the intraosseous regional administration (iora) group, and the investigators will use historical controls for the systemic intravenous administration (sia) group, to include a matched group of patients from 6 months prior to enrollment. sia group will receive systemic dosing of cefazolin within one hour of the incision, which is the current standard of care. iora group will receive intraosseous dosing after the tourniquet is inflated to 300-350mm/hg. cefazolin 1 gram will be given through an intraosseous cannula, placed into the medial aspect of the proximal tibia, after draping and before skin incision. the cefazolin will be administered as a bolus in 200 ml of normal saline. incision will be made immediately after infusion. subjects in both groups will receive routine care following the procedure. primary outcome will be acute surgical site infection, which is defined as within 3 weeks after the surgical procedure. secondary outcomes will include correlation of clinical comorbidities to the primary outcome, report complications, and compare surgery specific information (tourniquet time, blood loss). subjects with a penicillin allergy will receive a 200mg cefazolin test dose via a systemic intravenous route, which is the current standard of care. if no adverse reaction is observed, then the investigators will proceed with administration of 1g cefazolin via the intraosseus route.

Eligibility criteria:
inclusion criteria: •primary diagnoses of osteoarthritis exclusion criteria: * history of compartment syndrome * allergy to an antibiotic in the study * venous stasis * peripheral vascular disease
feasibility and acceptability study of my sleep our sleep (msos) program

Conditions: Insomnia

Summary: the purpose of this study is to test feasibility and acceptability of a psycho-behavioral intervention on sleep in cancer patients and their partners.


Eligibility criteria:
inclusion criteria: patients: 1. newly diagnosed with a gastrointestinal cancer (stage i to iv) 12 months or less prior to participating 2. 18 years or older 3. able to speak/read english at the 5th grade level 4. having a consistent partner who is involved in daily activities including sleep 5. having 5 or greater score on the pittsburgh sleep quality index. sleep partners: 1. 18 years or older 2. able to speak/read english at the 5th grade level 3. a partner of the patient who is involved in the patient's daily activities including sleep 4. having similar circadian rhythm/sleep patterns with the patient 5. having 5 or greater score on the pittsburgh sleep quality index. exclusion criteria: patients and their sleep partners: 1. having had a diagnosis of dementia, psychotic disorder, major depressive disorder, bipolar disorder, which currently has not been treated 2. having active suicidality in the past year 3. currently having an untreated diagnosed sleep disorder (narcolepsy, restless leg syndrome) 4. currently having have a poor physical functioning status as measured by an eastern cooperative oncology group (ecog) score of 3 or higher and karnofsky grade of 50 or lower 5. having poor cognitive function status as measured by the mini mental state examination score of 24 or less 6. unable to see or hear 7. at the end of life (life expectancy of less than a month) 8. unwilling to change their current sleep-related habits in near future.

Keywords: sleep disturbance in gi cancer patients and their sleep partner
nxt post-market clinical follow-up

Conditions: Urinary Incontinence; Urinary Obstruction; Urinary Bladder, Overactive; Urinary Bladder, Neurogenic; Urinary Incontinence, Urge

Summary: nxt urodynamics system post-market clinical follow-up clinical investigation to confirm ongoing safety and performance in urodynamic patient sub-populations

the primary objective of this study is to confirm the safety and performance of nxt urodynamic system for the intended patient populations, medically indicated for urodynamic study.

Eligibility criteria:
inclusion criteria: * patients medically indicated for urodynamic study * patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements exclusion criteria: * patients or legally authorized representative with cognitive or psychiatric condition that interferes with or precludes direct and accurate communication regarding the study, giving informed consent or ability to complete the patient questionnaire * patients with confirmed active bladder infections (not including patients with asymptotic bacteria) * pregnant women * patients with recent (less than 2 weeks) pelvic floor surgery * requires use of suprapubic catheter
the effect of ultrasonography-guided fascial plane blocks in breast cancer surgery patients

Conditions: Breast Cancer

Summary: the aim of this study was to evaluate the efficacy of serratus anterior plane (sap) block, pectoserratus plane (pecs ii) block, and erector spinae plane (esp) block on postoperative acute pain, quality of recovery and chronic pain in breast cancer surgery patients.

breast cancer is the most common type of cancer in women. although surgical treatment is effective and curative, it is associated with many complications in the postoperative period. acute pain after surgery is one of them. approximately half of women undergoing breast surgery describe significant post-operative pain (\>5 on the visual analogue scale; vas) score that is not always effectively controlled by standard post-operative treatments. poorly controlled postoperative pain has been associated with impaired functional recovery, delayed discharge from the post-anesthetic care unit, and prolonged hospital stay. in addition, poorly managed acute pain becomes chronic and is described as 'post-mastectomy pain syndrome'. regional techniques can reduce acute and chronic postoperative pain. the development of ultrasonography (us)-guided regional anesthesia has led to the development of fascial plane blocks. serratus anterior plan (sap) block, pectoserratus plan (pecs ii) block, and erector spina plan (esp) block are frequently used for postoperative analgesia in patients undergoing breast surgery. he aim of this study was to evaluate the efficacy of serratus anterior plane (sap) block, pectoserratus plane (pecs ii) block, and erector spinae plane (esp) block on postoperative acute pain, quality of recovery and chronic pain in breast cancer surgery patients.

Eligibility criteria:
inclusion criteria: * elective breast surgery (modified radical mastectomy, breast conserving surgery, simple mastectomy, axillary lymph node dissection, etc.), * 18 to 65 years old, * american society of anaesthesiology (asa) score i-iii * body mass index (bmi) \<32 kg/m2 exclusion criteria: * contraindications to the block applications * history of mental or neurological disorders * history of chronic opioid use * chronic alcoholism * substance use * treatment of chronic pain * severe liver and kidney disease * uncooperative patients * patients scheduled for bilateral mastectomy

Keywords: regional anesthesia postoperative pain recovery quality chronic pain breast cancer
total knee arthroplasty: relation between patient satisfaction and implant geometry

Conditions: Osteoarthritis

Summary: a rct (randomized controlled trial) comparing 3 different tka (total knee arthroplasty) implant designs and investigating the relation between patient satisfaction and the implant geometry.


Eligibility criteria:
inclusion criteria: * male and female patients of all ages, scheduled for tka * primary osteoarthritis of the knee joint * post traumatic arthritis * rheumatoid arthritis exclusion criteria: * previous tka in same joint * evidence of neuromuscular or neurosensory deficiency * immunologic suppression

Keywords: total knee arthroplasty patient satisfaction proms implant design
management of indeterminate thyroid nodules across different world regions

Conditions: Indeterminate Thyroid Nodules

Summary: thyroid carcinoma (tc) is the most common endocrine malignancy, affecting 0.2-1.5% of individuals worldwide. the rising incidence rate of tc is mostly related to the expanding use of high-quality imaging techniques, with an increase in the detection of thyroid nodules. fine needle aspiration cytology (fnac) is the most accurate, rapid, safe, and cost-effective test for the evaluation of thyroid nodules, with high specificity and sensitivity. nevertheless, fnac is particularly unreliable in differentiating between benign and malignant nodules that fall under the category of indeterminate thyroid nodules (class iii and class iv according to bethesda classification\[2\]). in fact, in these cases, the expected malignancy rates are 5-15% and 15-30%, respectively. thus, most patients with indeterminate thyroid nodules undergo an operation that is indeed unnecessary, while representing a risk for surgical complications and a cost for health-care systems. we aim to evaluate different approaches to indeterminate nodules across different countries in the world.


Eligibility criteria:
inclusion criteria: * patients with bethesda iii / bethesda iv thyroid nodules exclusion criteria: * patients with preoperative diagnosis of lymph node metastases

Keywords: indeterminate thyroid nodule thyroid carcinoma