Kornimate/medical-research-clean huggingface dataset:
prochlorperazine versus acetaminophen, aspirin, and caffeine for the treatment of acute migraine

Conditions: Migraine Headaches

Summary: the objective of this randomized, double blind study is to demonstrate that one dose oral "excedrin migraine" (acetaminophen, aspirin and caffeine) is not inferior when compared to one dose of intravenous prochlorperazine for the treatment of acute migraine headaches in the emergency department.

patients with severe headaches often come to the emergency department seeking relief from their symptoms. there is some dating suggesting that over the counter treatment options are not inferior to treatment options offered in emergency departments. patients presenting to the einstein emergency department with ihs criteria for migraine headache will be approached by research associate and offered to participate in a randomized double blind study comparing excedrin migraine to compazine. patients will be randomized by the hospital pharmacy. the pharmacy will distribute one of two packets, one containing prochlorperazine 10mg and 2 placebo tablets, the other containing 2 generic aac tablets without scoring (acetaminophen 250mg, aspirin 250mg and caffeine 65mg in each tablet) and a placebo syringe. patients will be monitored for improvement of pain, change in vital signs, and adverse events for two hours after receiving drugs. at 24 hours, the patients will be called back to access if they experienced any side effects from the time of discharge, and if they would take this medicine again if they experienced another migraine.

Eligibility criteria:
inclusion criteria: * 18 years or older * headache must meet the ihs criteria for migraine or probable migraine * 2 out of 4 of following: * unilateral location * throbbing (pulsating) quality * moderate to severe intensity (inhibits/prohibits daily activities) * exacerbation with moderate activity or mild activity * during ha, at least 1 out of 3 of following: * nausea and/or vomiting * photophobia * phonophobia exclusion criteria: * known allergy to study medications * pregnancy * \< 18 years old * inability to provide written, informed consent * patients with positive lumbar puncture or positive ct scan for suspected secondary headache * history of peptic ulcer disease * history of liver failure * history of coagulopathy * gastrointestinal bleeding within the last 3 months * previous gastrointestinal bleeding with non-steroidal anti-inflammatory medications * ingestion of other pain medications within the previous six hours deemed to put the patient at risk of exceeding a toxic dose of asa or acetaminophen (\> 100mg/kg for asa or acetaminophen) * vomiting within one hour of receiving oral study medications.

Keywords: headache prochlorperazine excedrin migraine treatment efficacy pain scores
long-term effects of bariatric surgery

Conditions: Obesity

Summary: the primary objective of labs-2 is to use standardized techniques and measures to assess the longer-term safety and efficacy of bariatric surgery by: 1. comparing post-surgical outcomes to pre-operative status 2. examining risks and benefits of surgery. labs-2 will determine the associations between clinical/demographic patient characteristics, components of the surgical procedure, and peri-operative and post-operative care with post-operative risks and changes in patient status. funds are not available to pay for the surgery for patients, only to address research questions.

the primary goal of labs-2 is to evaluate the efficacy and safety of bariatric surgery over a longer term than labs-1, i.e., more than 30 days. using a sample of the labs-1 cohort, approximately 2,400 patients, will be recruited over 3 years. labs-2 will include clinical assessments and detailed interviews and questionnaires pre-operatively and at several post-operative time points (30 days, 6 months, 12 months following surgery, and annually thereafter) to assess risks of surgery, and changes in clinical, metabolic, and psychosocial characteristics in patients, and health care utilization following bariatric surgery. detailed data about the surgical procedure and peri- and post-operative care will also be collected to determine if components of the surgical procedure, and peri-operative and post-operative care as well as clinical/demographic patient characteristics are associated with post-operative risks and changes in patient status. patients enrolled in labs-2 will provide blood specimens pre-operatively and post-operatively to address labs-2 hypotheses and additional samples will be stored at the niddk tissue repository for serologic, pathologic and genomic testing of other hypotheses.

Eligibility criteria:
inclusion criteria: * patients who are at least 18 years of age and undergo bariatric surgery by a labs certified surgeon * previous enrollment in labs-1 * selected by algorithm to be included in labs-2 exclusion criteria: * informed consent not obtained * prior bariatric surgery * unlikely to comply with follow-up protocol * unable to communicate with local study staff

Keywords: obesity
chest pain unit ii register

Conditions: Chest Pain

Summary: multicentric, prospective, non-interventional observational study with two parts: 1. a register of quality assurance within the recertification of clinics 2. an extended register with scientific protocol.

1. quality assurance as a quality-assuring basic register, the cpu ii register checks the extent to which certified chest pain units fulfill the criteria published by the dgk. in particular, the following quality dimensions are evaluated: * indication quality * diagnostic quality * therapeutic quality * structural quality / networking 2. platform for projects with a scientific focus the cpu ii register and the infrastructure provided are a platform for further projects with scientific questions (scientific protocol = wp): wp: clinical history after cpu (pci data / discharge / 12-month fup) in patients with leading cardiac diagnosis

Eligibility criteria:
inclusion criteria: * cpu patient * \> 18 years * written consent of the patient exclusion criteria: * denied consent
comparison study of the glycemic effects, safety, and tolerability of exenatide once weekly suspension to sitagliptin and placebo in subjects with type 2 diabetes mellitus

Conditions: Diabetes Type 2

Summary: to compare the effect on glycemic control (hba1c) of exenatide suspension administered once weekly to that achieved by sitagliptin or placebo administered once daily for 28 weeks in subjects with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * at least 18 years old * diagnosed with type 2 diabetes mellitus * hba1c of 7.1% to 11.0%, inclusive, at screening * has stable body weight, i.e., not varying by \>3% for at least 3 months prior to screening * fasting plasma glucose concentration \<280 mg/dl (15.5 mmol/l) at screening * body mass index of \<45 kg/m2 at screening * has been treated with a stable regimen of ≥1500 mg/day metformin for a minimum of 2 months prior to visit 1 (screening) exclusion criteria: * history of pancreatitis or triglycerides \>=500 mg/dl * medullary carcinoma or multiple endocrine neoplasia (men2) or a family history of either * history of renal transplantation, or is currently receiving renal dialysis, or has an estimated creatinine clearance \<50 ml/min * active cardiovascular disease * presence or history of severe congestive heart failure * central nervous system disease, including epilepsy * liver disease * history of severe gastrointestinal diseases * clinically significant malignant disease * repeated severe hypoglycemia within the last 6 months * any exposure to exenatide (byetta® or bydureon™) or any glp-1 analog * any dpp-4 inhibitor within 3 months prior screening

Keywords: diabetes, type 2, exenatide, sitagliptin
use of epidermal expansion system for epidermal grafting on hypopigmented skin and surgical wounds

Conditions: Surgical Wound; Hypo-pigmented Skin

Summary: this case series will assess the use of suction blister epidermal grafts harvested by a novel device on select patients with hypo pigmented skin or surgical skin wounds.

this study evaluates a novel micrografting technique to determine how it will influence the repigmentation of selected areas of hypopigmentation, and how it will influence the healing and pigmentation of surgical skin wounds. the epidermal expansion system (designed by momelan technologies) will generate an array of small microblisters and transfer the micrografts to a sterile fda cleared wound dressing for application to the subject's acute wound or prepared recipient site. the sponsor hypothesizes that applying expanded micrografts to target sites will result in rapid healing of acute wounds and in repigmentation of hypopigmented skin as well as and provide improved cosmetic outcomes.

Eligibility criteria:
inclusion criteria: * male or female adult subject between 18 and 99 years of age * subject having an area of hypopigmentation or surgical wound considered appropriate by physician to receive epidermal micro grafting * willingness to participate in study by evidence of informed consent exclusion criteria: * female subjects self-reported to be breastfeeding, pregnant or planning to become pregnant during the course of the study. * subject showing clinical signs of infection * subjects currently on immunosuppressive medications, chemotherapy or cytotoxic agents * subject participation in another interventional study with potential exposure to an investigational drug or device within the past 30 days or planned entry into another investigational study within 90 days after entrance into this study

Keywords: skin surgery micrografting hypo-pigmentation
prospective evaluation of treatment for clubfoot

Conditions: Clubfoot Deformity

Summary: specific aim: to evaluate the outcome of infants who undergo one of two nonsurgical treatment interventions

purpose: the purpose of this project is to help orthopaedic surgeons better understand and treat patients with a diagnosis of clubfoot. this proposed research will establish a protocol for the collection of relevant clinical and functional outcome measures on our patients with a diagnosis of clubfoot.

Eligibility criteria:
inclusion criteria: * patients with a diagnosis of clubfoot deformity * spanish speaking patients will be eligible to participate in the study. exclusion criteria: * all patients without a diagnosis of clubfoot

Keywords: clubfoot, deformity, correction, management, gait
etos: minimal hepatic encephalopathy in childhood and young adult: epidemiological study and pilot interventional study

Conditions: Hepatic Encephalopathy

Summary: the aim of the study is: * epidemiological/observational: investigating the presence of neuropsychological and electrophysiological alterations, suggesting a condition of minimal hepatic encephalopathy(and its behavioral correlates), in childhood and young adulthood affected by pre-hepatic portal hypertension due to portal vein thrombosis, even for implementing specific diagnostic protocols. * interventional: collecting preliminary data on the effects of a probiotic, in order to implement a controlled clinical study.

epidemiological/observational study investigating the presence of neuropsychological and electrophysiological alterations, suggesting a condition of minimal hepatic encephalopathy(and its behavioral correlates), in childhood and young adulthood affected by pre-hepatic portal hypertension due to portal vein thrombosis, even for implementing specific diagnostic protocols

Eligibility criteria:
inclusion criteria: * extra-hepatic portal vein thrombosis * 4-20 years * knowledge of italian language * absence of perceptive or communicative deficit * absence of psychiatric disease or mental retardation exclusion criteria: * medical contraindications for required evaluations * infective pathologies * parenchymal hepatic pathologies

Keywords: minimal hepatic encephalopathy pre-hepatic portal hypertension portal vein thrombosis
effects of sodium-glucose co-transporter 2 inhibitors on inflammation

Conditions: Inflammation

Summary: the research aims to understand how a specific type of medication called sodium-glucose co-transporter 2 (sglt2) inhibitors affect cardiorenal inflammation.


Eligibility criteria:
inclusion criteria: * age: ≥18 * patient has no prior history or use of sodium-glucose co-transporter 2 inhibitors. * women who are surgically sterilized, amenorrheic for a year, on long-term contraceptives like intrauterine devices and implantable and injectable contraceptives. * willing and able to complete the outcome assessments. exclusion criteria: * history of cardiac diseases (heart failure, nstemi/stemi, cardiomyopathies, myocarditis). * diagnosis of type i diabetes mellitus. * symptomatic hypotension (symptoms of hypotension + systolic blood pressure \< 90). * estimated glomerular filtration rate \<25 ml/minute/1.73 m2, with renal function test done within a year from the study enrollment date. * alcohol use disorder as defined by the niaaa or use of controlled substances or smoking cigarettes. * history of dapagliflozin or other sodium-glucose co-transporter 2 inhibitor sensitivity. * other concomitant disease or condition that the investigator deems unsuitable for the study, including psychiatric, behavioral, or cognitive disorders, sufficient to interfere with the patient's ability to understand and comply with the study instructions or follow-up procedures. * women who are pregnant or intend to become pregnant

Keywords: sglt2 inhibitors dapagliflozin inflammation
cognitive consequences of an activation of the cortical drive to breath (ventipsy)

Conditions: Ondine Syndrome; Healthy; Amyotrophic Lateral Sclerosis

Summary: the purpose of the study is to measure the negative cognitive consequences of the ventilation under pathological or experimental cortical drive to breath.

cognitive capacities are measured on healthy subject submitted to inspiratory threshold loading, patients treated by chronic mechanical ventilation due to suffering ondine syndrome or amyotrophic lateral sclerosis. the spontaneous breathing is compared to niv breathing or inspiratory threshold loading.

Eligibility criteria:
inclusion criteria: * adults and non-vulnerable adults * fluent in french exclusion criteria: for patients: * total ventilatory dependency * coexistence of an other respiratory disease * alcohol and /or psychotropic consumption during the last 24 hours * one or more episodes of acute respiratory failure during the past 6 months * serious cognitive deficiency or presence of fronto temporal dementia * end-stage disease * no affiliation to social security for healthy volunteers: * existing respiratory disease * alcohol and /or psychotropes consumption during the last 24 hours * tobacco smoking more than 2 pack-years * sleep deprivation * serious cognitive deficiency * no affiliation to social security
hybrid transvaginal-transabdominal endoscopic surgery

Conditions: Gallstones; Appendicitis; Pelvic Pain

Summary: the is a pilot study to evaluate the safety and efficacy of hybrid transvaginal-transabdominal procedures. diagnostic peritoneoscopy (visualizing the inside of the abdomen), appendectomy (removal of the appendix), and cholecystectomy (removal of the gallbladder) will be performed through a vaginal incision with an additional small incision in the umbilicus.


Eligibility criteria:
inclusion criteria: * chronic or early appendicitis * symptomatic gallstones * suspicious abdominal mass/nodule * female * age 18-60 years * asa class i or ii exclusion criteria: * pregnant women * history of previous abdominal, pelvic, or vaginal surgery * history of previous abdominal or pelvic radiation therapy * history of fibroid uterus * history of endometriosis * history of large ovarian cyst * history of unexplained vaginal bleeding or dyspareunia

Keywords: gallstones appendicitis pelvic pain peritoneal mass
neoadjuvant epirubicin, cisplatin and capecitabine (ecx) followed by definitive chemoradiation with/without surgery for squamous cell carcinoma of the oesophagus

Conditions: Oesophageal Carcinoma

Summary: this is a study to investigate the efficacy and safety of epirubicin, cisplatin and capecitabine (ecx) as neoadjuvant therapy prior to radical chemoradiotherapy using capecitabine and cisplatin as radio-sensitisers in patients with newly diagnosed localized squamous cell carcinoma of the oesophagus.


Eligibility criteria:
inclusion criteria: * age \> 18 years. * histologically verified squamous cell carcinoma of the cervical or thoracic oesophagus * american joint committee on cancer (ajcc) stage i-iii (t1-3 n0-1 m0) (33), as assessed by spiral or multi-slice computed tomography (ct) and endoscopic ultrasound, where radical chemoradiation would be considered with curative intent. * no previous chemotherapy, radiotherapy or other investigational drug treatment for this indication. * world health organization (who) performance status 0,1 or 2. * adequate bone marrow function with platelets \> 100 x 10\^9/l; white blood cells (wbc) \> 3 x 10\^9/l; neutrophils \> 1.5 x 10\^9/l at the time of study entry. * serum bilirubin \< 35 micromol/l. * serum creatinine \< 180 micromol/l and measured creatinine clearance over 60 ml/min. * no concurrent uncontrolled medical condition. * no previous malignant disease other than non-melanotic skin cancer or carcinoma in situ of the uterine cervix in the last 10 years. * life expectancy \> 3 months. * adequate contraceptive precautions if relevant. * informed written consent. exclusion criteria: * the presence of locally advanced or metastatic disease precluding curative chemoradiation (t4 or stage iv or m1a-b) or disease not encompassable in a radical radiotherapy field. * total dysphagia (o'rourke's swallowing function scoring system 5) precluding swallowing of capecitabine even when crushed. * medical or psychiatric conditions that compromise the patient's ability to give informed consent. * intracerebral metastases or meningeal carcinomatosis. * new york heart association classification grade iii or iv. * uncontrolled angina pectoris. * pregnancy or breast feeding. * impaired renal function with measured creatinine clearance less than 60 ml/min. * previous investigational study drug * known malabsorption syndromes * patients with a known hypersensitivity to fluorouracil (5-fu) or with a dihydropyrimidine dehydrogenase (dpd) deficiency * hearing loss
romtech portableconnect rehabilitation device usage post unilateral total knee arthroplasty (tka)

Conditions: Knee Osteoarthritis; Knee Arthritis; Knee Pain Chronic; Knee Disease; Joint Pain; Osteo Arthritis Knee; Osteoarthritis, Knee

Summary: romtech is focused on transforming the healthcare market by delivering lower extremity rehabilitation systems that are effective, efficient for patient use, cost-effective, and provide better patient outcomes while simultaneously decreasing rehabilitation and overall recovery times.

the patented technology of the romtech portableconnect can improve the rehabilitation protocol for lower extremities in shorter time periods. the focus of this study is to compare the effectiveness of the romtech portableconncect device only rehabilitation program following total knee arthroplasty to an active comparator group of continuous passive motion with a standard of care combination hhpt and oppt rehabilitation program. the technology used to develop the romtech portableconnect device has been reported in a pilot study to tend to be highly effective in decreasing the recovery time of patients post tka, as discussed in the findings from the pilot study with the romtech pro cycle. the expedited recovery resulting from use of the romtech rehabilitation technology is noted to be contributed to the ability of the romtech technology to achieve a more rapid range of motion in this patient population.

Eligibility criteria:
inclusion criteria: * male or female ≥18 years of age at screening visit. * documentation of a definitive diagnosis of osteoarthritis of the knee requiring total knee arthroplasty. * scheduled or willing to schedule tka procedure within the timelines consistent with the study enrollment period. this includes up to a 28-day screening window prior to the scheduled surgery. * willing to consent to outpatient, home-based physical therapy, cpm, or the romtech protocol * able to provide written informed consent. * willing and able to participate in and complete all study assessments, questionnaires, and procedure exclusion criteria: * inability to provide informed consent. * inability to understand and complete study related assessments and procedures. * other scheduled surgical knee procedures in addition to the tka. * presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the subject or the quality of the data. * history of musculoskeletal or neurological disorders that limit physical function including but not limited to severe spine oa, contralateral leg issues limiting mobility, and other disorders as identified by the investigator * planned additional knee joint surgery within 3 months of the primary scheduled tka

Keywords: romtech portableconnect osteoarthritis remote monitoring home health physical therapy outpatient physical therapy rehabilitation physical therapy
vagus nerve stimulation and stress reduction training for migraine

Conditions: Migraine

Summary: this study design has two components: 1) a cross-sectional assessment of brain activity and inflammation in migraine patients compared to healthy controls and 2) an assessment of 8 weeks of a combination therapy approach to treating migraine.

chronic pain is the most prevalent and disabling medical condition, and no single therapy has proven to be completely successful for alleviating pain, such as migraine headache. it is well documented, and recommended in the recent institute of medicine (iom) report, that a multimodal approach is optimal for pain management. this study will evaluate a combination transcutaneous vagus nerve stimulation and stress reduction training for migraine. investigators will recruit participants who have migraines and randomize to one of four potential treatment arms (real or sham stimulation + real or sham stress reduction training). brain imaging (mri and pet) and clinical data will be collected before and after 8 weeks of the combination therapy. healthy controls will also be recruited for collection of the same baseline brain imaging and clinical data, but with no treatment or second data collection phase. findings from this research will help elucidate brain activity and inflammation associated with migraines and evaluate the efficacy of the combination therapy in reducing migraine.

Eligibility criteria:
inclusion criteria: 1. subjects must be between 18 and 65 years of age. 2. migraine diagnosis and general health otherwise. 3. willingness to attend twice- weekly treatment session at cambridge health alliance for 8 weeks. 4. able to give written consent and participate in group interventions in english. healthy volunteers between the ages of 18 and 65 can participate in this study. exclusion criteria: 1. major illness, psychiatric condition, or neurological disease. 2. previous experience with stress reduction training (such as mindfulness training, mbsr, mbct, relaxation response) or more than 15 home mediation practice sessions in the past month, or more than 10 classes in yoga, tai chi, or qi gong in the past 3 months 3. any condition that would prohibit mri scanning healthy volunteers have the same eligibility constraints with the addition of current or past history of migraine.