Kornimate/medical-research-clean huggingface dataset:
transversus abdominis plane (tap) block for cesarean section

Conditions: Hyperalgesia, Secondary

Summary: the purpose of this study is to determine whether a transversus abdominis plane (tap) block with clonidine added to the injectate (clo-tap) performed approximately 2hrs after the cesarean section (cs) will decrease the amount of postoperative hyperalgesia and ultimately reduce post-cs chronic pain.

acute severe pain after cesarean section (cs) occurs more often than is thought and 10-15% of the women having a cesarean section develop chronic pain (kehlet et al. 2006). with over 1.3 million cesarean deliveries per year in the us, this is bound to create a significant health problem. one way to address this health burden is to refine techniques that may help control the pain women experience after cs and ultimately reduce the potential to develop chronic pain. the purpose of this randomized, double-blinded study is to evaluate the ability of an established anesthetic technique called the transversus abdominis plane (tap) block to reduce the amount of hyperalgesia women develop around their incision after cs. measuring the amount of punctuate mechanical hyperalgesia is used as a tool to assess postoperative central sensitization (lavand'homme et al. 2005), which contributes to postoperative acute pain. since postoperative acute pain has been shown to be predictive of developing postoperative chronic pain (eisenach et al. 2008; yarnitsky et al. 2008), an effective tap block could help diminish the incidence of chronic pain after cs. in addition, blood samples will be collected for future genetic analysis and we will test preoperatively for mechanical temporal summation (mts) to evaluate cns (central nervous system) sensitization and nociceptive system hyperexcitability and see if this correlates with the amount of hyperalgesia women develop around their incision after surgery. the primary aim of this study is to evaluate the benefits of two different solutions injected by tap block technique on postoperative peri-incisional hyperalgesia.

Eligibility criteria:
inclusion criteria: * non-laboring women who will benefit from and have clinically consented to a scheduled or non-scheduled cesarean delivery under spinal anesthesia * english speaking (uw site) or portuguese speaking (brazil site) * aged between 18 and 45 years * bmi \< 40 * asa physical status class i or ii exclusion criteria: * laboring women undergoing a non-scheduled cesarean delivery * non-english speaking (uw site) or non-portuguese speaking (brazil site) * previous spinal surgery * contraindications for neuraxial anesthesia * allergy to local anesthetic, ultrasound conduction gel, or clonidine * history of chronic pain * inability to receive intraoperative toradol

Keywords: postoperative hyperalgesia pain transversus abdominis plane block tap block cesarean section
transpulmonary thermodilution measurements in patients with heart diseases

Conditions: Heart Diseases

Summary: the purpose of this study is to examine the validation of the picco (pulse contour cardiac output)-derived transpulmonary thermodilution technology in patients with heart diseases.

* how do picco and pac (pulmonary artery catheter) derived hemodynamic variables change in different cardiac pathologies? * how do picco hemodynamic variables compare to transthoracic echocardiographic parameters in different cardiac pathologies? * how does gedv (global enddiastolic volume) correlate with left ventricles end-diastolic volume (lvedv) assessed by lv (left ventricle) ventriculography and echocardiography? * how do picco cardiac function variables (gef \[global ejection fraction\]; cfi \[cardiac function index\]) correlate with lv dp/dt max, lvef (left ventricular ejection fraction) assessed by lv ventriculography and echocardiography, lvfac (left ventricular fractional area of change), lv stroke work index (lvswi) and cardiac power (cp)? * how does gedv compare to lvedv and left ventricular end-diastolic pressure (lvedp) as assessed by the pulmonary artery occlusion pressure (paop)? * how does right ventricular function influence gedv, gef and cfi?

Eligibility criteria:
inclusion criteria: * coronary heart disease without impaired left ventricular function \[lv-ef \> 50%\] (n=10, control group) * coronary heart disease with impaired left ventricular function \[lv-ef \< 50%\] (n=10) * dilated cardiomyopathy (n=10), * aortic valve stenosis (n=10), * mitral valve regurgitation (n=10), * diastolic left ventricular dysfunction (n=10) and * right heart failure (n=10) exclusion criteria: * patients with catecholamine dependent cardiogenic shock, severe respiratory distress because of pulmonary oedema, intubated patients, patients with atrial fibrillation, atrioventricular conduction abnormalities, and slow ventricular tachycardia will not be included. * moreover patients not being able to give informed consent are excluded. even more, pregnant women are excluded from the study due to the radiation exposure in line with heart catheterization. a pregnancy test will be performed prior to participating with this study. * the age does not represent an exclusion criterion.
a study to evaluate the safety, tolerability and pharmacokinetics of amg 403 in subjects with osteoarthritis knee pain

Conditions: Osteoarthritis

Summary: this is a sequential, randomized, double-blind, placebo controlled, multiple dose, dose escalation study in subjects with oa knee pain (n=32; 8/cohort). in each cohort, subjects will be randomized 3:1 to receive sc amg 403 or placebo once every 4 weeks for a total of 4 doses (q28d x 4).


Eligibility criteria:
inclusion criteria: * diagnosed with knee oa as determined by acr criteria: knee pain and radiographic osteophytes and at least 1 of the following 2 items: morning stiffness 30 minutes, crepitus on motion, a vas pain score of ≥ 30 mm for index knee at screening, exclusion criteria: * weight of \> 125 kg, inflammatory arthropathy including secondary oa (eg, degenerative arthritis in patients with rheumatoid arthritis) as confirmed by a rheumatologist or investigator, diagnosis of a condition other than knee oa that, in the investigator's opinion, may cause or affect pain or pain assessment in the index knee; these conditions may include but are not limited to radiculopathy or neuropathy, vasculopathy, fibromyalgia or active depression, subjects taking neuromodulatory agents (antiepileptics or antidepressants) used as analgesic therapy for neuropathic pain
survey of xgeva® presrcibers in europe to evaluate their knowledge of the summary of product characteristics pertaining to osteonecrosis of the jaw

Conditions: Solid Tumours; Bone Metastasis

Summary: osteonecrosis of the jaw (onj) is an adverse effect of antiresorptive therapy that is well-recognized in patients with advanced cancer. detailed information regarding this risk is specified in the summary of product characteristics (spc). the statements in the spc are the most important mechanism for minimizing the risk for onj. the study objective is to measure the knowledge of oncology practitioners prescribing xgeva® regarding the content pertaining to onj in the spc after commercial availability.

this is a multiple cross-sectional survey study of practicing oncology practitioners prescribing xgeva in europe from across but not limited to the 5 largest european countries by population (including france, germany, italy, spain and the u.k.) and 4 nordic countries (denmark, finland, norway and sweden). the survey will be conducted in two rounds. the two survey rounds will be conducted 12 to 18 months and 24 to 30 months after xgeva becomes commercially available in the participating countries. the initial contact and screening of potential participating oncology practitioners will continue until a total of 210 eligible and consenting oncology practitioners complete the survey per round. for the 5 largest european countries by population, it is intended that 30 oncology practitioners will be surveyed per country per survey round. if this sample size cannot be achieved, oncology practitioners from another country in that region will be surveyed to achieve a regional sample size of 150 per survey round. oncology practitioners from the nordic countries will be surveyed to achieve a regional sample size of 60 per survey round. for all countires, the number of surveys collected in each country in the second survey round will, where possible, equate to the number of surveys collected in each country in the first survey round.

Eligibility criteria:
practicing oncology specialists who have treated at least 5 adult patients with bone metastases from solid tumours in the last quarter. must have prescribed xgeva® within the last 12 months. must not have participated in a previous survey round

Keywords: solid tumours bone metastasis
tremor monitoring device

Conditions: Parkinson's Disease; Essential Tremor

Summary: patients with tremor may have varying degrees of tremor at different times. the amplitude and frequency of tremor may change. the investigators observational study is intended to document this tremor.


Eligibility criteria:
inclusion criteria: * patients with tremor due to parkinson's disease or essential tremor exclusion criteria: * severe dementia
dovee - diagnosing ovarian & endometrial cancer early

Conditions: Ovarian Neoplasms

Summary: this study hopes to improve early detection of ovarian and endometrial cancers. it will determine if women with bloating, abdominal distension, abdominal/pelvic pain, increased urinary frequency and/or early satiety, benefit from earlier surgery after screening by ca-125 ovarian cancer biomarker and transvaginal ultrasound.


Eligibility criteria:
inclusion criteria: 1. sign an approved informed consent form (icf). 2. be ≥ 45 years of age. 3. have at least one symptom outlined in below for a period of ≥2 weeks but ≤ 1 year: * feeling full after eating only a few bites, loss of appetite * diarrhea, constipation, bowel or rectum feels full, change in bowel habits, constant urge to have a bowel movement, painful or burning bowel movements, rectal pain, painful defecation * bloating, distension of abdomen, clothes around the waist feel too tight, feel an abdominal mass * weight loss not because of dieting * nausea, vomiting, heartburn, gas, burping, indigestion * increased urinary frequency, need to urinate urgently, pressure on the bladder, leaking urine, burning sensation when urinating, need to urinate but unable to do so, unable to empty bladder completely, feeling full after urinating * vaginal discharge, bleeding, spotting, deep pain on intercourse * discomfort or pain in abdomen, or pelvic region, or lower back 4. subjects must be willing to comply with study protocol exclusion criteria: 1. previous bilateral salpingo-oophorectomy (bso) 2. previous diagnosis of cancer in the ovaries, fallopian tubes, or peritoneum 3. current bleeding per rectum, not due to haemorrhoids 4. current frank haematuria 5. symptoms that suggest the need for urgent clinical evaluation outside of a research protocol

Keywords: aged algorithms ca-125 antigen/blood* chi-square distribution early detection of cancer* feasibility studies female humans logistic models mass screening/methods* middle aged neoplasm grading neoplasm invasiveness neoplasm staging ovarian neoplasms/diagnosis* ovarian neoplasms/epidemiology ovarian neoplasms/immunology ovarian neoplasms/ultrasonography pilot projects predictive value of tests prevalence prognosis prospective studies quebec/epidemiology tumor burden
pd-1 inhibitor combined with 125i seed implantation for hepatocellular carcinoma's extrahepatic metastasis: efficacy and safety

Conditions: HCC - Hepatocellular Carcinoma; 125I Seeds Implantation

Summary: this study aims to explore the effectiveness and safety of 125i seed implantation in the treatment of hepatocellular carcinoma (hcc) with extrahepatic metastases, and to compare the efficacy differences between pd-1 inhibitor monotherapy and the combination of pd-1 inhibitor and 125i seed implantation. a retrospective analysis was conducted on 80 eligible patients admitted to jiangxi provincial cancer hospital from january 2018 to march 2025, with 40 patients in each group. data including patients' basic characteristics, tumor staging, alpha-fetoprotein (afp) levels, history of hepatitis b virus (hbv) infection, etc., were collected. parameters of seed implantation and details of metastatic lesions were recorded. through regular follow-ups after treatment, the degree of pain relief (evaluated by visual analogue scale, vas), tumor control efficacy (response rate, rr; local control rate, lcr), survival outcomes (local progression-free survival, lpfs; progression-free survival, pfs; overall survival, os) were assessed. additionally, indicators such as blood cell analysis, liver and kidney function, and treatment-related adverse reactions were monitored, providing a clinical basis for optimizing comprehensive treatment regimens for hcc with extrahepatic metastases.


Eligibility criteria:
inclusion criteria: * (1) diagnosis of advanced primary hepatocellular carcinoma (hcc) according to established criteria \[13\]; (2) presence of ≥1 measurable extrahepatic metastatic lesions; (3) eastern cooperative oncology group (ecog) performance status score of 0; (4) barcelona clinic liver cancer (bclc) stage c; (5) child-pugh class a or b; (6) platelet count \> 75×10⁹/l; (7) estimated life expectancy \> 3 months; (8) complete clinical data available. exclusion criteria: * (1) poor treatment compliance or inability to cooperate with ¹²⁵i seed implantation surgery; (2) unavoidable large bronchi or major blood vessels along the puncture pathway for seed implantation; (3) history of other primary malignant tumors (except cured non-melanoma skin cancer or in-situ carcinomas); (4) severe cardiorenal insufficiency (e.g., new york heart association class iii/iv heart failure or estimated glomerular filtration rate \< 30 ml/min/1.73m²); (5) incomplete clinical data or loss to follow-up before the study endpoint.

Keywords: hepatocellular carcinoma 125i seed implantation pd-1 inhibitors efficacy
cisplatin,docetaxel and s-1 for advanced gastric and gastroesophageal junction cancer

Conditions: Gastric Cancer; Gastroesophageal Junction Cancer

Summary: the combination of cisplatin and s-1 (cs) achieved a response rate of approximately 45% with the pfs being around 6 months and overall survival time being 13 months in japanese and chinese gastric patients. it remains unclear whether the addition of docetaxel to cs would further enhance the efficacy as it dose in dcf(docetaxel, cisplatin and 5-fluorouracil). this is a single center, phase ii clinical trial to evaluate the efficacy of docetaxel, cisplatin and s-1 (dcs) as first line chemotherapy for patients with advanced gastric and gastroesophageal junction cancer.

this is a single arm trial. all patients will receive up to 6 cycles of triple chemotherapy with docetaxel, cisplatin and s-1. given the severe toxicity of dcf regimen, here the total dose of docetaxel and cisplatin is both reduced to 60mg/m2. for patients with cr/pr/sd disease after 6 cycles of chemotherapy, maintenance therapy with s-1 are recommended. antitumor activity will be evaluated every two cycles according to recist1.1.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed unresectable advanced gastric or gastroesophageal junction cancer; * no previous chemotherapy and radiation for advanced disease except palliative radiation for a local pain control; * at least one evaluable lesion per recist (response evaluation criteria in solid tumors) 1.1; * ecog (eastern cooperative oncology group) performance status 0-1; * recovery from the toxicities of previous therapy; * adequate bone marrow and organ function. hb≥8 g/l; absolute neutrophil ≥ 2.0 g/l; plt ≥100 g/l ;alt/ast ≤1.5 uln or ≤5uln with liver metastases; tbil ≤1.5 uln; cr≤1.0 uln; * life expectancy ≥3 months; * for men and women of childbearing potential, agree on taking effective contraceptive method of birth control from the signed informed consent until 3 months after the last study drug administration; * signed informed consent. exclusion criteria: * pathology type other than adenocarcinoma,such as squamous cell carcinoma; * previous treatment with taxanes, cisplatin or s-1; * relapse within 6 months after the end of adjuvant chemotherapy; * known brain metastases; * complete or incomplete intestinal obstruction or uncontrolled gastrointestinal bleeding; * known deficiency of dpd enzyme; * kown hiv infecton or drug addiction; * any acute or chronic medical or psychiatric condition that would make the patient inappropriate for entry into this trial in the judgement of investigators; * myocardial infarction within 6 months prior to the entry of this trial; * known history of allergic reaction to taxanes and platinum; * pregnant or breast feeding women.

Keywords: gastric cancer gastroesophageal junction cancer chemotherapy docetaxel cisplatin s-1
macular function after scleral buckle

Conditions: Rhegmatogenous Retinal Detachment

Summary: assess recovery of macula function after successful scleral buckling surgery for rhegmatogenous retinal detachment by using the multifocal erg in the postoperative period i.e. recovery of functional integrity 2. assess the relationship between the neurosensory retina and the retinal pigment epithelium/choriocapillaris after scleral buckling i.e. recovery of structural integrity 3. assess if there is a difference between macula function postoperatively, in eyes with retinal detachments involving the macula and those that do not.

patients with acute rhegmatogenous retinal detachments managed by scleral buckling surgery will be recruited into 3 groups. (please see attached appendix a) we define the area of the macula as the area within the temporal vascular arcades with the horizontal radius defined between the optic disc and the foveal centre. group a: macula not detached group b: macula partially detached i.e. detachment stops within the macula group c: macula is totally detached after scleral buckling surgery for the retinal detachment, the patients will be examined at day 1, week 1, month1, 3 and 6. during these visits, they will be examined clinically, as well as undergo tests - refraction, colour vision (d-15) \& contrast sensitivity testing, oct and multifocal erg. (please see attaced visit schedule).

Eligibility criteria:
inclusion criteria: * acute rhegmatogenous retinal detachment undergoing scleral buckling surgery exclusion criteria: * only eye patients * patients who undergo surgery which require use of intravitreal gases * patients who will not be able to cooperate for the mferg and oct testing * patients with macula hole detachments * fellow eye with poor vision resulting in inability to fixate for the mferg

Keywords: retinal detachment macular function multifocal electrophysiology
the 4th month oral consultation at pregnant women

Conditions: Periodontal Diseases; Pregnancy

Summary: epidemiological studies have suggested that maternal periodontitis affects the fetal-placental unit, with an increased risk of adverse pregnancy outcome. indeed, it has been suggested that the direct or indirect action of parodontopathogenic bacteria induces an inflammatory cascade that leads to spontaneous premature labor. also, non-treatment of caries and periodontal disease can lead to acute pain and stress. this may promote self-medication and the inappropriate use of analgesic medications, potentially harmful to the health of the fetus. as part of the prevention of complications of pregnancy associated with oral diseases, the national agency for accreditation and evaluation in health (anaes) has set up a system that allows any pregnant woman to consult between the 4th and 7th month of pregnancy, an oral health professional to carry out a complete assessment and free care. this study aims at evaluating this device among pregnant women and healthcare professionals 4 years after its implementation. on the other hand, it will make it possible to look for a possible link between the realization of an oral prenatal follow-up and the outcome of the pregnancy.

this study will concern two populations: * pregnant women attending hospital during pregnancy monitoring and / or being hospitalized in one of the maternity wards associated with the project, * health professionals in charge of the follow-up of these pregnant women and their childbirth. the study will include: * 500 pregnant women: 300 in nantes and 200 in brest * 150 health professionals.

Eligibility criteria:
inclusion criteria for pregnant women: any woman who is consulting or hospitalized in a maternity unit participating in the project is eligible for the following criteria: * a voluntary adult woman who gave oral consent * pregnant women (2nd and 3rd trimesters) or postpartum women hospitalized at the maternity ward * women agreeing to participate in the study for health professionals: * midwife, maieutician, gynecologist and obstetrician, * have graduated from a specialty, * agreeing to participate in the study exclusion criteria for pregnant women: * child * person under curatorship, under guardianship, deprived of liberty, * refuse to fill in the questionnaire, * no understanding of oral or written french, for health professionals: - not graduated

Keywords: oral health pregnancy prevention adverse pregnancy outcomes
a study testing safety and tolerance of the rewalk exoskeleton suit

Conditions: Paraplegia; SCI

Summary: the rewalk enables people with lower limb disabilities to carry out routine ambulatory functions (stand, walk, climb stairs etc.). it can be used by people with disabilities such as spinal cord injury, brain injury, stroke, multiple sclerosis, cerebral palsy and other severe walking impairments. the device promises to restore the dignity of disabled persons, enabling them to work and improve their general health and quality of life, as well as significantly reduce medical and other related expenses.

the rewalk comprises light wearable brace support suit, which integrates dc motors at the joints, rechargeable batteries, an array of sensors and a computer-based control system. it is snugly fitted on the body and worn underneath the clothing, if desired. rewalk is a new realization of the powered exoskeleton concept, first tried about fifty years ago with no success. employing an innovative, non-robotic design approach, it uniquely matches the user's capabilities with the control mechanisms. upper-body movements of the user are detected and used to initiate and maintain walking processes. user stability and safety during ambulation is secured by concurrent use of safety aids such as crutches for walking and railing for stairs.

Eligibility criteria:
inclusion criteria: * chronic (at least 6 months after injury) complete cervical(c7-8) or thoracic (t1-t12) spinal cord injury * age between 18-55 * male and non-pregnant non-lactating female * regular use of rgo or bing able to stand up using a device (e.g. easystand) * under 100 kg and between 155-200 cm of height exclusion criteria: * history of severe neurological injuries other than sci (ms, cp, als, tbi etc) * severe concurrent medical diseases: infections, heart or lung, pressure sores * unstable spine or unhealed limbs or pelvic fractures * psychiatric or cognitive situations that may interfere with the study

Keywords: rewalk, paraplegia, sci