Kornimate/medical-research-clean huggingface dataset:
cardiac index changes with ephedrine, phenylephrine, ondansetron and norepinephrine during spinal anesthesia

Conditions: Cardiac Output, Low

Summary: the purpose of the study is to evaluate the cardiac output changes after an intravenous bolus of ephedrine, phenylephrine, ondansetron or norepinephrine during a spinal anesthetic for a cesarean delivery. for elective cesarean delivery, all participants will receive spinal anesthesia with a local anesthetic and sufentanil. this study includes 120 pregnant women. patients will be randomly assigned according to a computer generated system to be in one of four groups.

this study will be a prospective, randomized, double-blind controlled trial. after written and informed consent are obtained, the study participants are randomly assigned using a computer generated table to 1 of 4 treatment groups prior to cesarean delivery. group a: 9 mg of ephedrine group b: 100 mcg of phenylephrine group c: 8 mg of ondansetron group d: 0,25 mcg/kg of norepinephrine baseline arterial blood pressure and heart rate will be measured in the left lateral tilt position, before anesthesia and then every minute.the cardiac output is calculated on the apical cut 5 cavities, before anesthesia and then every 5 miutes. no fluid preloading will be administered till delivery. the primary endpoint is cardiac output changes in each groups. the secondary endpoint is the number of provider interventions needed to maintain the sbp within 80-120% of baseline for each groups. bradycardia (hr less than 50 bpm) will be treated with 1 mg of atropine. hypotension ( decrease of more than 20% of the baseline value or a pas \<90 mm hg) will be treated with 6 mg of ephedrine, without any fluid loading. the spinal anesthesia will be carried out in a seated position, level l3-l4 or l4-l5 with a slow injection over 30 seconds of a mixture of 10 mg of 0.5% bupivacaine with 5 mcg of sufentanil. the hot / cold test to determine the block level is required. a spinal anesthesia is validated if the cold test reaches the t4 level. the 10 ml syringe will be administered immediately after spinal anesthesia. the patient will be placed in the left lateral tilt position of 15¤, then put back into strict dd immediately after the delivery. cardiovascular parameters (pas, pam, pad, hr) will be recorded every minute until delivery. echocardiographic measurement of cardiac output will be recorded every five minutes until delivery. measured variables will include systolic, diastolic and mean non-invasive blood pressure, the number and type of interventions for control of blood pressure, heart rate, cardiac output, incidence of nausea and vomiting (nv), incidence of arrhythmia and fetal cord blood analysis (ph) at delivery.

Eligibility criteria:
inclusion criteria: * asa i / ii * caesarean section, non-twinned exclusion criteria: * heart disease * hta * non-gestational diabetes * pre-eclampsia * sepsis * bmi greater than 40 * contraindication to spinal anesthesia: patient refusal, medicinal allergy, long qt syndrome.

Keywords: spinal anesthesia cardiac output vasopressor
assessing the herv-w env antagonist gnbac1 for evaluation in an open label long-term safety study in patients with multiple sclerosis

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: the humanised igg4 monoclonal antibody gnbac1 targets the envelope protein (env) of the human endogenous multiple sclerosis-associated retrovirus (herv-w msrv), which may play a critical role in multiple sclerosis. the study assesses the long-term safety of gnbac1 in patients with rrms and the long-term efficacy of gnbac1 in terms of mri outcomes, relapse rate, disability and disease progression.


Eligibility criteria:
main inclusion criteria: * patients must have completed period 2 of study gnc-003 and must meet all eligibility criteria for the gnc-004 study * patients (male or female with reproductive potential) must agree to use highly effective methods of birth control * provision of written informed consent to participate prior to any trial procedure as shown by signature on the subject consent form. main exclusion criteria: * patients not having completed the study gnc-003 * pregnancy * the emergence of any disease diagnosis during the course of study gnc-003 that is not ms and could better explain the patient's neurological signs and symptoms

Keywords: multiple sclerosis multiple sclerosis relapsing-remitting gnbac1 mri monoclonal antibody multiple sclerosis associated retrovirus msrv ms rrms herv-w temelimab
hot or cold beverages in warm weather

Conditions: Quality of Life

Summary: some studies have suggested that hot beverages are better for cooling down when body temperature rises. no study has investigated the effect of hot beverages in hot weather on personal well-being compared to cold beverages.

the research project will be conducted as a double-blinded randomized crossover trial, where the participants will drink either 10 cl of 10°c cold tea (±2°c) or 50°c hot tea (±2°c), which in a pilot study and in the literature \[1,9\] has been shown to be without discomfort or side effects. the order of the two interventions will be randomized. all participants must be adults (18 years or older) and not have a fever on the day of the experiment. prior to participation, participants must provide written informed consent and must show up in clothing they find comfortable in the sun and be wearing sunscreen and a sun hat/cap. participants must also complete a questionnaire on basic background information: gender, age, height, weight, clothing during the trial, and the participant's preference regarding the climate and temperature of beverages. walk-through of study: 1. participants lie or sit in the sun for 10 minutes without drinking anything. 2. then, participants drink their allocated beverage in ≤ 5 sec. while still in the sun. 3. approximately 3 minutes (±1 min.) after ingestion of the beverage intervention, participants must answer all questionnaires and have their temperature measured. 4. afterward, participants stay in the shade for 5 minutes (wash-out period). 5. participants lie down (or sit) in the sun for the second time for 10 minutes without drinking anything. 6. then, participants drink their second allocated beverage in ≤ 5 sec. while still in the sun. 7. approximately 3 minutes (±1 min.) after ingestion of the second beverage intervention, participants must again answer all questionnaires and have their temperature measured. 8. data collection and the research project end thereafter

Eligibility criteria:
inclusion criteria: * 18 years or older * must be able to ingest intervention * must be able to be in the sun for 2x 13 minutes (using sunscreen and/or other relevant uv protection). exclusion criteria: * fever on the day of the experiment.
viral load changes in lymphoma patients with hcv infection after chemotherapy

Conditions: Lymphoma; Hepatitis C Antibodies; Drug Therapy

Summary: in last few years, most researches about hepatic complication after chemotherapy focused on hepatitis b virus (hbv). with adequate prophylaxis and monitor, hbv-related hepatitis flares can be prevented. in contrast, cancer patients with hepatitis c virus (hcv) infection are traditionally considered as relative safe to receive chemotherapy. however, two large retrospective studies recently showed that severe hepatitis could develop in 14-27% lymphoma patients with chronic hcv infection, including 3-4% hepatic failure. the risk factors to predict severe hepatitis are pre-treatment elevated alt level and liver cirrhosis. due to the lack of prospective studies, the dynamic changes of serum hcv rna levels and the association of hepatitis are still unclear. some epidemiologic studies demonstrated an association between hcv infection and b-cell lymphoma. diffuse large b-cell lymphoma (dlbcl) is the most common lymphoma and several reports showed higher prevalence of hcv infection among dlbcl patients than the controls. hcv infected dlbcl patients are reported to have distinct clinical characteristics, such as older, more with elevated ldh levels, and more with extra-nodal involvement. regarding the impact of hcv infection on prognosis, the results are conflicting. taiwan is an endemic area of hcv but there are limited reports addressing the clinical characteristics and prognosis in this unique population. therefore, the investigators initiate a prospective, multi-center observational study to clarify the dynamic association between serum hcv rna levels and hepatitis in hcv-infected lymphoma patients treated with chemotherapy.


Eligibility criteria:
inclusion criteria: 1. newly diagnosed histologically proven malignant lymphoma 2. eligible subjects must be positive for anti-hcv ab 3. age ≥ 20 years 4. planned to receive chemotherapy 5. no recent chemotherapy and radiotherapy in the past one year. pre-enrollment steroids for symptomatic relief are allowed but less than equivalent dose to prednisolone total 140 mg 6. left expectancy ≥ 3 months 7. signed informed consent 8. ecog 0-2 exclusion criteria: 1. patients not willing to receive chemotherapy 2. chronic hepatitis b infection (positive for hbsag), but those with resolved hbv infection (positive for anti-hbc and negative for hbsag) are allowed 3. other major systemic diseases, such as active infection, significant cardiac disease, neurologic deficit or psychiatric disorders, that the investigators consider to be at significant risk 4. known human immunodeficiency virus (hiv) infection 5. pregnant or breast-feeding woman

Keywords: lymphoma, hepatitis c virus, chemotherapy
comparison of biofilm characteristics between an in situ biofilm model of supragingival plaque and natural teeth

Conditions: Biofilm; Dental Plaque

Summary: the purpose of this study is to determine in situ the bacterial viability, thickness and bacterial diversity of a biofilm formed on different substrates in comparison to a naturally tooth-formed oral biofilm. in addition, it will be evaluated whether the restraint of oral hygiene measures may influence the development of the pl-biofilm.

* to calculate an a priori sample size, the following statistical criteria were established: an effect size of 0.35, an alpha error of 0.05 and a statistical power of 87%. assuming these criteria and using the repeated measures anova test, a sample size of 15 subjects was required. * bacterial viability and thickness will be analyse by confocal laser scanning microscope and live/dead backlight staining solution. * bacterial diversity will be analyse by pyrosequencing the 16s dnar gene.

Eligibility criteria:
inclusion criteria: * systemically healthy * good oral health status exclusion criteria: * smoker or former smoker, * presence of dental prostheses or orthodontic devices, * antibiotic treatment or routine use of oral antiseptics in the previous 3 months, * presence of any systemic disease that could alter the production or composition of saliva

Keywords: pyrosequencing 16s dna gene confocal laser scanning microscope bacterial viability bacterial diversity
effect of preoperative diclofenac potassium on postoperative endodontic pain

Conditions: Pulpitis - Irreversible

Summary: the purpose of this study is to assess the effect of preoperative a single-dose of 50 mg diclofenac potassium on postoperative endodontic pain in mandibular molars with symptomatic irreversible pulpitis.

patients with moderate-to-severe preoperative pain are selected. patients receive either a single-dose of 50 mg diclofenac potassium (group a) or a placebo tablet as a control (group b). all patients receive the assigned premedication one hour before single-visit root canal treatment. postoperative endodontic pain is measured at the following time points: 6 , 12,24,48 h after treatment. the incidence of analgesic intake is also recorded.

Eligibility criteria:
inclusion criteria: * patients with active pain (moderate-to-severe) in mandibular molars. * patients with prolonged response to cold testing and electric pulp tester. * patient with the ability to understand and use pain scales. * patient with vital coronal pulp tissue on access. * patient who accept to enroll to the study. exclusion criteria: * patients' allergies or any other contraindication to diclofenac potassium or articaine. * pregnant and lactating females. * patients having pain medication in the last 6 hours. * patient has more than one symptomatic mandibular tooth in the same quadrant. * patients with periradicular pathosis and/or radiolucency other than widened periodontal ligaments. * patients with active peptic ulcer and gastrointestinal disorders. * patients with history of bleeding problems or anticoagulant use within the last month.

Keywords: pulpitis, irreversible pulpitis, diclofenac potassium premedication, preoperative analgesic postoperative pain
communicating objective risk for personalized decision making about mammography

Conditions: Breast Cancer

Summary: the purpose of this study is to test the effects of objective risk information about breast cancer and mammography outcomes using a randomized control trial. women between the ages of 35 and 49 will receive information about their personal risk for breast cancer and be randomly assigned to receive data about a woman who should be screened, data about the potential outcomes of screening, or data about breast cancer deaths. two presentation formats will be tested and compared.

this study will compare alternative strategies for the presentation of individualized information about the risks and benefits of mammography screening. the purpose of this study is to understand how objective risk information influences outcomes including behavioral intentions, attitudes about mammography, and emotional responses. after participants view objective risk information, a post-test survey will measure outcome variables including behavioral intentions, knowledge, and emotional responses. after reading information based on their condition, study participants will be asked to complete a series of questions to measure their reactions based on their condition. specifically, the investigators will be measuring the following dependent variables (primary outcomes): behavioral intentions to receive mammograms, attitudes about mammography, subjective norms about mammography and breast cancer screening, knowledge about mammography outcomes and screening recommendations, and emotional responses to the material including psychological reactance. these outcomes will be measured using self-reported questionnaire items. in this project, the investigators will compare alternative communication strategies to determine which strategy or strategies result in the greatest level of understanding. the investigators also will examine if the various strategies differentially affect the primary outcomes listed above.

Eligibility criteria:
inclusion criteria: * adult women between the ages of 35 and 49 will be invited to participate in this study. exclusion criteria: * women who have been previously diagnosed with breast cancer or have tested positive for the breast cancer gene will not be included.
neuropsycholgy and neuroimaging in transient global amnesia

Conditions: Transient Global Amnesia (TGA)

Summary: the purpose of this study is to establish a diagnosis in transient global amnesia (tga) in assessing three episodic memory's abilities (mental simulation throught the future, and the past, the learning of personnal actions i-e the enactment effect). secondary goal is to describe the neuronal substrates associated to the alteration of theses abilites in tga.


Eligibility criteria:
inclusion criteria: * all the participants * minimum of 7 years of education * french native speaker * healthy subjects : non pathological dementia rating scale score * patients : clinical diagnosis of tga according to hodges and warlow's criterion exclusion criteria: * chronic neurological disease * encephalitis * endocrinal disease * hepatic disease * case history of head injury with loss of consciousness of more than one hour * case history of stroke * case history of cancer during the five last years except squamous cell carcinomas * alcoholism or drug addiction * major psychiatric disorders according the diagnostic and statistical manual of -mental disorders
open-label extension (ole) study of wve-004 in patients with c9orf72-associated amyotrophic lateral sclerosis (als) and/or frontotemporal dementia (ftd)

Conditions: ALS; FTD

Summary: this is an ole study conducted to evaluate the safety, tolerability, pharmacokinetics (pk), pharmacodynamics (pd), and clinical effects of wve-004 in adult patients with als, ftd, or mixed als/ftd phenotype with a documented mutation in the c9orf72 gene. to participate in the study, patients must have successfully completed phase 1b/2a wve-004-001 study.


Eligibility criteria:
inclusion criteria: * patient successfully completed the phase 1b/2a study with wve-004, wve-004-001. exclusion criteria: * patient has a clinically significant medical finding on the physical examination other than c9orf72-associated als or ftd that, in the judgment of the investigator or sponsor, will make the patient unsuitable for participation in and/or completion of the trial procedures. * patient received any other investigational drug, biological agent, or device within 1 month or 5 half-lives of study agent, whichever is longer. patient received an investigational oligonucleotide within the past 6 months or 5 half-lives of the drug, whichever is longer.
adaptive-design dose finding study to assess the antiviral efficacy and safety of nim811 administered in combination with standard of care (soc) in relapsed hepatitis c virus 1 (hcv-1) infected patients

Conditions: Chronic Hepatitis C Genotype-1 Relapse

Summary: this is a study designed to identify a dose of nim811 that has a good safety profile, is well tolerated when co-administered with soc, and provides a clinically meaningful effect in viral load reduction compared to soc alone. this information will be used to support doses selected for future studies.


Eligibility criteria:
inclusion criteria: patients eligible for inclusion in this study have to fulfill all of the following criteria: * chronic hepatitis c genotype-1 * hcv-rna should be ≥ 4 x 105 iu/ml at screening * recipient of prior long acting interferon and ribavirin treatment for at least 12 weeks, with documented negative serum hcv rna on treatment, who subsequently becomes serum hcv rna positive after stopping treatment ("relapser"). patients must have been off all treatment for at least 3 months prior to start of study (visit exclusion criteria: * use of any hcv treatment ≤ 3months prior to study start * prior receipt of any investigational anti-hcv therapy which is not ifn or rbv * women of child-bearing potential unless they are post-menopausal or use predefined acceptable methods of contraception * pregnant or breastfeeding women * evidence of cirrhosis, hepatic decompensation, other than hcv liver disease, hbv or hiv infection * specified abnormalities in lab values of amongst others hemoglobin, wbc, anc, platelets * history of treatment for depression * steroid/immunosuppression drug use 3 months prior to study start other protocol-defined inclusion/exclusion criteria may apply

Keywords: nim811 chronic hepatitis chronic hepatitis c chronic hepatitis c genotype-1 hcv hcv-1 relapser
"the effect of the use of an autotransfusion device on hemodynamic parameters during resuscitation".

Conditions: Out of Hospital Cardiac Arrest; Cardiac Arrest

Summary: the purpose of the research (pilot study) is to determine the impact of the use of the autotransfusion device on hemodynamic parameters during resuscitation. 24 people will be included in the pilot study (12 people will be included in the intervention group - with the usage of "autotransfusion socks" during resuscitation and 12 people in the control group - without "autotransfusion socks"). investigators will compare the hemodynamic parameters and also neurological outcome between both groups.

the purpose of the research (pilot study) is to determine the impact of the use of the autotransfusion device on hemodynamic parameters during resuscitation. out-of-hospital cardiac arrest (ohca) is one of the leading causes of death in europe. in order to improve the hemodynamic parameters during resuscitation, device for autotransfusion was developed. devices are basically a very strong elastic stockings that also block arterial circulation. while "putting on" stockings, blood is being squeezed from the lower extremities (approximately 500 ml of blood for each lower limb). with blood being squeezed from the lower limb into the central circulation the filling of the heart is being improved; thus the device will improve the preload and also cardiac output. a study done on an animal model showed that during resuscitation using "autotransfusion socks" increases both systolic and diastolic blood pressure during resuscitation, the perfusion of the coronary arteries improves and also the values of the partial pressure of carbon dioxide increases.

Eligibility criteria:
inclusion criteria: * ohca (out of hospital cardiac arrest) * age \> 18 years * intubated * meets criteria for resuscitation exclusion criteria: * age \< 18 years * not intubated * clinical signs for dvt (deep vein thrombosis), pe (pulmonary embolism) * clinical signs of acute inflammation of limbs, broken limbs etc. * known oncological patient * asphyxia * trauma patients

Keywords: cardiac arrest out of hospital cardiac arrest resuscitation
efficacy, safety and tolerability of different bowel preparation before colonoscopy in children over 2 years old

Conditions: Child Obesity; Bowel Preparation

Summary: electronic colonoscopy plays an important role in the diagnosis and follow-up of intestinal diseases in children.

the adequacy of bowel preparation before colonoscopy is particularly important for the visualization of intestinal mucosa under colonoscopy. some studies have shown that bowel preparation must be customized according to the age, weight and clinical status of the child. however, there is no internationally recognized standard scheme for pediatric intestinal reserve. in pediatric clinical trials, polyethylene glycol with electrolyte solution (peg-els) is more effective than bisacodyl, folium sennae and magnesium citrate. peg-els is an electrolyte balanced isotonic solution, which can be used to clean the intestinal tract by large volume irrigation. polyethylene glycol 4000 is a long-chain linear polymer, which can hardly absorb and decompose after oral administration. it can effectively increase the composition of intestinal fluid, stimulate intestinal peristalsis, cause watery diarrhea, and achieve the purpose of cleaning the intestine. the inorganic salt composition and proper amount of water in the formula ensure the balance of water and electrolyte exchange between intestinal tract and body fluid. in this study, peg-els short protocol and long protocol were selected for intestinal preparation, and the effectiveness and safety of different intestinal preparation protocols under electronic colonoscopy for children over 2 years old were compared.

Eligibility criteria:
inclusion criteria: * newly diagnosed children in department of gastroenterology at children's hospital of fudan university * according to the indications of electronic colonoscopy, colonoscopy was performed for the first time * age: 2-22 years old exclusion criteria: * having contraindications of electronic colonoscopy * having contraindications of general anesthesia * previous abdominal surgery * chronic constipation * there is evidence of intestinal stenosis and gastrointestinal malformation * laxatives or drugs in the intestinal preparation protocol of this study have been used before bowel preparation * disagree the use of the bowel preparation protocol developed in the study

Keywords: child electronic colonoscopy bowel preparation polyethylene glycol with electrolyte solution