Kornimate/medical-research-clean huggingface dataset:
prevention of post-mastectomy breast pain using ambulatory continuous paravertebral blocks

Conditions: Paravertebral Catheter Insertion; Mastectomy; Breast Cancer

Summary: research study to determine if putting local anesthetic-or numbing medication-through a tiny tube placed next to the nerves that go to a breast prior to and following a mastectomy will decrease subsequent pain.

specific aim 1: to determine if, compared with current and customary analgesia, the addition of a multiple-day ambulatory continuous paravertebral block decreases the incidence and severity of post-mastectomy pain. hypothesis 1: following mastectomy, the incidence and severity of breast pain will be significantly decreased in the week following surgery with a multiple-day ambulatory continuous paravertebral block as compared with patients receiving standard-of-care treatment (as measured on the 11-point numeric rating scale). hypothesis 2: following mastectomy, the incidence and severity of chronic pain will be significantly decreased three months following multiple-day ambulatory continuous paravertebral blocks as compared with patients receiving standard-of-care treatment (as measured on the 11-point numeric rating scale).

Eligibility criteria:
inclusion criteria: * undergoing unilateral or bilateral mastectomy * desiring analgesia with a paravertebral nerve block(s) * age 18 years or older * female exclusion criteria: * morbid obesity as defined by a body mass index \> 40 * renal insufficiency * chronic opioid use * history of opioid abuse * any comorbidity which results in moderate or severe functional limitation * inability to communicate with the investigators or hospital staff * pregnancy * incarceration

Keywords: breast cancer mastectomy ucsd surgery pvb catheter paravertebral catheter breast pain mastectomy pain postoperative pain
neoadjuvant chemotherapy followed by preoperative chemoradiation in resectable squamous-cell esophageal cancer

Conditions: Esophageal Neoplasms; Squamous Cell Carcinoma; Concurrent Chemoradiotherapy

Summary: this study is conducted to evaluate efficacy and safety of neoadjuvant chemotherapy followed by preoperative chemoradiotherapy in patients with resectable esophageal squamous cell carcinoma

this study is conducted to evaluate efficacy and safety of neoadjuvant chemotherapy followed by preoperative chemoradiotherapy in patients with resectable esophageal squamous cell carcinoma. patients with resectable esophageal squamous cell carcinoma receive 2 cycles of neoadjuvant chemotherapy (paclitaxel 175 mg/м2 iv day 1, cisplatin 75 mg/м2 iv day 1, fluorouracil 750 mg/m2/day continuous infusion, day 1-4 every 3 weeks). patients who do not progress with distant metastases start preoperative chemoradiotherapy (paclitaxel 50 mg/m2 + cisplatin 20 mg/m2 weekly + radiotherapy 44 gy for 4 weeks). 4-6 weeks after completion of chemoradiation patients undergo ivor lewis esophagogastrectomy irrespectively of objective response.

Eligibility criteria:
inclusion criteria: 1. age 18-75 2. histologically or cytologically confirmed resectable squamous-cell tumor (t)1-2 node (n)+, t3n0-3 esophageal cancer. inclusion of patients with morphologically confirmed and potentially resectable supraclavicular lymphnodes (unilateral, less than 1,5 cm in short axis) is allowed 3. no prior antineoplastic treatment 4. eastern cooperative oncology group (ecog) status 0-2 5. adequate organ function, evidenced by laboratory results with no contraindications to chemotherapy * absolute neutrophil count ≥ 1,500 х109/l * thrombocytes ≥ 100 х 109/l * hemoglobin ≥ 90 mg/l * creatinine \< 115 µmol/л or creatinine clearance ≥ 55 ml/min * alanine aminotransferase (alt) and aspartate aminotransferase (ast) \> 2.5 x upper limit of normal (uln) * alkaline phosphatase (alp) \> 5 x uln * bilirubin \> 1,5 х uln 6. women of childbearing potential must have negative pregnancy test, performed 7 days prior to initial treatment 7. patients must follow appropriate contraception rules during whole treatment period 8. decrease of body weight must not be more than 20% in last 6 months exclusion criteria: 1. presence of distant metastases except for metastatic supraclavicular lymphnodes; 2. bulky (\>3 cm) regional lymphnodes metastases; 3. cervical esophageal cancer; 4. presence of tumor fistula; 5. prior malignant tumor, except for proper treated skin basal cell carcinoma and in situ cervical cancer; 6. active infectious diseases and concomitant diseases that can affect treatment tolerability, surgery and other study procedures;

Keywords: esophageal squamous cell carcinoma preoperative chemoradiotherapy preoperative chemotherapy
the effect of household-based screening on blood pressure changes in south africa

Conditions: Hypertension; Blood Pressure

Summary: this study will evaluate the effect of household-based screening and care encouragement for blood pressure on subsequent changes in blood pressure. the study uses a quasi-experimental regression discontinuity design with existing population-based secondary data from the 2008, 2010, 2012, 2014, and 2017 waves of the national income dynamics study in south africa.

household-based screening and referral to care for blood pressure may improve blood pressure control at the population level in many low- and middle-income countries. this observational study will use a quasi-experimental regression discontinuity design to evaluate the effect of household-based screening for blood pressure with care encouragement for potentially hypertensive individuals on subsequent changes in blood pressure over time. individuals had their blood pressure measured in the household as part of the national income dynamics study data collection. if individuals had a measured blood pressure in the hypertensive zone, they were told that they had elevated blood pressure, that high blood pressure can lead to life threatening consequences, and that they should seek further care. the study exploits the fact that individuals were given this information based on a hard blood pressure cutoff. therefore, the investigators will evaluate the causal effect of this household-based intervention in the absence of randomization by comparing individuals with a baseline blood pressure just above and below the cut off.

Eligibility criteria:
inclusion criteria: * age greater than or equal to 30 * valid blood pressure measurements exclusion criteria: * prior diagnosis of hypertension * currently taking medication for blood pressure * measured with a blood pressure above 140 mmhg systolic or 90 mmhg diastolic in a previous wave of data

Keywords: causal inference regression discontinuity
study to assess the pharmacokinetics, pharmacodynamics, and safety of canagliflozin (jnj-28431754) in otherwise healthy obese volunteers

Conditions: Healthy

Summary: the purpose of this study is to assess the pharmacokinetics (ie, how the body affects the drug) and pharmacodynamics (ie, how the drug affects the body) of increasing doses of canagliflozin (jnj-28431754) in healthy obese volunteers.

this study will be a single-center, randomized (the treatment is assigned by chance), double-blind (neither investigator nor volunteer knows the identity of the assigned treatment), placebo-controlled (one of the study medications is inactive), ascending multiple dose study (increasing doses of study medication) to assess the pharmacokinetics and pharmacodynamics of canagliflozin (a drug currently being investigated for the treatment of type 2 diabetes mellitus) in otherwise healthy obese volunteers. the study will consist of 3 phases: a screening phase, a double-blind treatment phase, and an end of study (or follow-up) phase. volunteers will be assigned to 5 cohorts (groups) made up of 16 otherwise healthy obese men and women. within each group, 12 volunteers will be given canagliflozin once or twice daily and 4 volunteers will be given placebo (inactive medication) once or twice daily for 14 days. the dose of canagliflozin will be different for each of the 5 groups and the second group will not begin treatment until at least 21 days after the first group start treatment. this 21-day gap will be applied to all subsequent groups. each volunteer will participate in the study for approximately 58 days.

Eligibility criteria:
inclusion criteria: * volunteers must have a body mass index (bmi = weight in kg/height in m2) of 30.0 to 39.9 kg/m2 * volunteers must be non-diabetic as confirmed by fasting plasma glucose \<126 mg/dl * volunteers must be non-smoker or non-tobacco users (not smoked cigarettes or used tobacco-containing products for 3 months prior to screening) exclusion criteria: * history of or currently active illness considered to be clinically significant by the investigator or any other illness that the investigator considers should exclude the patient from the study or that could interfere with the interpretation of the study results * history of having taken anti-obesity medications (prescription or non-prescription) within 3 months of the screening visit, or anticipates a need to take any of these drugs during the course of the study * history of gastric banding, gastric bypass or other gastric-reduction surgery * history of eating disorder or recent significant changes in body weight due to dieting or nutritional treatment

Keywords: healthy canagliflozin (jnj-28431754) pharmacokinetics pharmacodynamics obesity
a study to assess treatment outcomes of abobotulinumtoxina and onabotulinumtoxina treatments in real life practice in toxin-naïve adult patients with limb spasticity.

Conditions: Spasticity Related to Any Cause Except Cerebral Palsy

Summary: the aim of the study is to describe treatment outcomes of abobotulinumtoxina (abobont-a) and onabotulinumtoxina (onabont-a) treatments, after one injection of either treatment, in toxin-naïve adult patients with upper and/or lower limb spasticity at a single national health service (nhs) centre in the united kingdom (uk).


Eligibility criteria:
inclusion criteria : * patient diagnosed with spasticity related to any cause except cerebral palsy. * patient initiated on treatment with either onabont-a or abobont-a during the study enrolment periods. * patient is an adult aged ≥18 years old at the time of the first bont-a injection for spasticity * patient has not received treatment with any type of bont-a 6 months prior to initiation of onabont-a or abobont-a. for patients with multiple courses of bont-a, separated by a gap of 6 months, only the first course will be evaluated in this study. * patient is being treated at haywood hospital at index date and during follow-up for up to 24 weeks post-index date, with medical records available for review. exclusion criteria : * patient is participating in an interventional clinical trial of an investigational medicinal product for the treatment of spasticity at index date and/or during follow-up.
observational study to evaluate allogeneic hsct outcomes for cerebral adrenoleukodystrophy (cald)

Conditions: X-Linked Adrenoleukodystrophy (X-ALD); Cerebral Adrenoleukodystrophy (CALD); Adrenoleukodystrophy (ALD)

Summary: study ald-103 will be a multi-site, global, prospective and retrospective data collection study that is designed to evaluate outcomes of allo-hsct in male subjects with cald ≤17 years of age.


Eligibility criteria:
inclusion criteria: 1. provide informed consent from a competent custodial parent or guardian with legal capacity to execute a local institutional review board (irb)/independent ethics committee (iec) approved consent. in addition, informed assent will be sought from capable subjects, in accordance with the directive of the institution's irb/iec and all other local requirements. 2. be male and ≤17 years of age at the time of treatment, for retrospective and partial prospective/retrospective subjects, or at the time of parental/guardian consent and, where appropriate, subject assent, for prospective subjects. 3. have a confirmed diagnosis of cald as defined by abnormal vlcfa profile and cerebral lesion on brain mri. 4. depending on the cohort, the subject must: * be scheduled for allo-hsct evaluation at a study site (prospective cohort only), * have received an allo-hsc infusion and be consented in time to complete the month 24 visit on study (partial prospective/retrospective cohort only), or * have received their most recent allo-hsc infusion on or after january 1, 2013 (retrospective cohort only). exclusion criteria: 1. previous treatment with a gene therapy product. 2. receipt of an experimental transplantation procedure.

Keywords: x-linked adrenoleukodystrophy hematopoietic stem cells
median effective dose of esketamine pretreatment to prevent sufentanil-induced cough

Conditions: Sufentanil; Esketamine

Summary: sufentanil has the advantages of fast onset time, strong analgesic function and cardiovascular stability, and is widely used during general anesthesia induction. however, sufentanil can cause cough during induction of general anesthesia. different studies have reported that the incidence of sufentanil-induced cough ( sic ) during anesthesia is 16-42 %. this pathological condition may lead to damage to the central nervous system, increase the risk of reflux and aspiration, increase intracranial pressure and intraocular pressure, and endanger patients with cerebral aneurysms and ocular trauma. therefore, at the moment of advocating comfortable anesthesia medical services, sufentanil-induced cough response is a problem that clinical anesthesiologists need to focus on and urgently solve. it has been reported that ketamine can reduce the incidence of cough caused by opioids. esketamine is a pure dextro-enantiomer of ketamine and an nmda antagonist with potent analgesic and bronchodilator effects. in this study, dixon sequential method was used to study the median effective dose ( ed50 ) of intravenous esketamine pretreatment to prevent sufentanil-induced cough, and to explore the effect of age on ed50. to provide reference for clinical rational selection of esketamine dose.


Eligibility criteria:
inclusion criteria: asa i-ii patients aged 18-59 years undergoing elective surgery under general anesthesia exclusion criteria: 1. preoperative intracranial pressure; 2. intra-abdominal pressure or intraocular pressure increased ; 3. have a history of cardiovascular and cerebrovascular diseases ; 4. have a history of asthma ; 5. have a history of chronic cough ; 6. have a history of smoking ; 7. there was a history of upper respiratory tract infection 2 weeks before operation; 8. patients received opioid therapy 2 weeks before surgery.; 9. patients who received angiotensin converting enzyme inhibitors, bronchodilators or steroids 2 weeks before surgery ; 10. abnormal liver and kidney function ; weight exceeded 20 % of the ideal weight ( male height - 100, female height - 105 ).
ambulatory measurement of physical activity in pancreatic cancer patients

Conditions: Unresectable Pancreatic Adenocarcinoma

Summary: pancreatic cancer is the 5th leading cause of death from cancer in france. when chemotherapy can be proposed, the choice of treatment is currently based on the patient's profile and expected tolerance. the endpoints currently used in trials, such as time to therapeutic failure, do not take into account the patient's experience of the disease. the use of quality of life questionnaires is often proposed, but frequent missing data and filling time can be a problem. in oncology, some studies have demonstrated, through questionnaires, the link between physical activity and quality of life. in this situation, ambulatory measurement of physical activity by wrist actimetry could be an integrative reflection of the impact of the disease and treatment (efficacy, tolerance) on patients. this type of evaluation, if accepted by patients, could usefully complement the measurement of quality of life in this population. no study has specifically looked at the use of devices of this type in the context of digestive cancer. the investigators propose to evaluate the acceptance of this type of device by pancreatic cancer patients receiving chemotherapy before evaluating its potential interest.


Eligibility criteria:
inclusion criteria: * patient with unresectable pancreatic adenocarcinoma for whom an indication for chemotherapy has been decided upon after a multidisciplinary consultation meeting; * adult patient; * patients able to understand spoken and written french, * patient has given consent. exclusion criteria: * who ecog stage iii or iv ; * patient suffering from a major physical disability (hemiplegia, paraplegia, myopathy, amputation of a limb); * any alteration of comprehension capacities making self-evaluation impossible; * protected adult; * patient not affiliated to a national health insurance scheme; * pregnant or nursing women.
optimized perioperative analgesia reduces the prevalence and the intensity of phantom pain in lower limb amputation

Conditions: Phantom Limb Pain

Summary: severe pre-amputation pain is associated with phantom pain development, and phantom pain models assign major importance to central and peripheral nervous system changes related to pre-amputation pain. several interventions have been evaluated for phantom pain prevention, including continuous brachial plexus blockade5, intravenous6 or epidural ketamine administration, postoperative perineural ketamine/clonidine infusion8 and oral gabapentin9, but their true effect remains unclear.

in a prospective, randomized, double-blind trial, 65 patients undergoing elective lower limb amputation were assigned to one of five analgesic regimens. patients in groups 1-4 had lumbar epidural catheter placed 48 hours before amputation, and received epidural bupivacaine/fentanyl or saline infusion before and/or after amputation. patients receiving epidural saline also had iv fentanyl patient-control analgesia, whereas patients receiving epidural analgesia also had iv saline. group 5 (control) received im meperidine and oral codeine/acetaminophen. vas and mcgill pain questionnaire (mpq) scores (for ischemic, phantom and stump pain) were recorded starting 48 hours before, continuing until 48 hours after amputation, and at 4 days, 10 days, 1 and 6 months after amputation. phantom and stump pain intensity and frequency were the main study endpoints.

Eligibility criteria:
inclusion criteria: * age \>18, visual analog. scale (vas) pain score \>70mm which was frequent or continuous one week before scheduled major (above or below knee) amputation, and patient consent. exclusion criteria: * no written patient consent * age \< 18 years * age \> 82 years * antiplatelet medication * mental status not acceptable * exclusion criteria were age \>85 * emergency amputation * ipsilateral re-amputation * foot or toe amputation * inability to complete a detailed pain questionnaire * history of chronic pain or substance abuse * active psychiatric disease requiring treatment * any contraindication to epidural catheter placement (anticoagulation, anti-platelet medications, previous lumbar spine surgery).

Keywords: phantom amputation analgesia pain preemptive perioperative lower limb amputation intensity of phantom limb pain preemptive analgesia reduces phantom pain perioperative analgesia reduces phantom pain severe phantom limb pain (vas>70 mm) resistant to medical treatment one week before amputation
neointimal coverage after implantation of biolimus eluting stent with biodegradable polymer: optical coherence tomographic assessment according to the treatment of dyslipidemia and hypertension and the types of implanted drug-eluting stents

Conditions: Stable Angina or Acute Coronary Syndrome Considered for Percutaneous Coronary Intervention With Dyslipidemia or Hypertension

Summary: there has been little research on neointimal coverage and malapposition after bes implantation using oct in human coronary artery. furthermore, specific drug may possibly influence the vascular healing after stent implantation. therefore, this study will investigate 1) neointimal coverage and malapposition on oct after bes versus ses implantation and 2) relationship of specific drug treatment and neointimal coverage or late malapposition by the prospective, randomized study.


Eligibility criteria:
inclusion criteria: 1. age ≥ 20 year old 2. in the case that the blood pressure at rest is greater than systolic 140mmhg or more than diastolic 90mmhg 3. when someone is taking anti-hypertensive medication 4. if total cholesterol is more than 200mg/dl and ldl-cholesterol is greater than 130mg/dl or if you are taking a statin 5. significant coronary de novo lesion (\> 70% by quantitative angiographic analysis) 6. patients with stable angina or acute coronary syndrome considered for percutaneous coronary intervention. 7. reference vessel diameter of 2.5 to 3.5 mm by operator assessment 8. stent size of 2.5 to 3.5 mm and stent length ≤ 24 mm exclusion criteria: 1. contraindication to anti-platelet agents 2. proximal leison within 15 mm from ostium 3. creatinine level 2.0 mg/dl or end stage renal disease on dialysis 4. pregnant women or women with potential childbearing 5. life expectancy less than 1 year 6. complex lesion morphologies (aorto-ostial, bifurcation with \>2.0 mm side branch, unprotected left main, thrombus, severe calcification, chronic total occlusion) 7. vein graft lesion

Keywords: ses vs bes