Kornimate/medical-research-clean huggingface dataset:
treatment of severe hypertension with icg directed therapy

Conditions: Hypertension in Pregnancy

Summary: the purpose of the study is to compare the usefulness of impedence cardiography (icg) directed therapy in treating severe range hypertension in pregnant women at term.

research protocol study design: randomized control trial this is a randomized control trial comparing the usefulness of impedance cardiography (icg) directed therapy in treating severe range hypertension (systolic bp \>160 or diastolic bp \>110) in patients greater than 20 weeks gestation. all patients in the study will receive standard of care medication within the suggested timeframe by the american college of obstetrics and gynecology (acog). all patients will receive a hemodynamic assessment prior to receiving and after receiving medications. the treatment patients will receive either labetalol or nifedipine therapy for hypertension based on their hemodynamic parameters. the control group will receive medication based on provider preference (which is the usual plan of care). study population: patients presenting to labor and delivery at cabell huntington hospital being treated for severe range blood pressures. consent will be obtained prior to randomization to standard care or icg directed care. patient age range will be from age 15 to approximately 45. schedule of assessment: an interval assessment will be performed after 20 patients have been assessed. the goal is for a total enrollment of 100 patients, 50 to the icg directed treatment group and 50 to the control group. study procedures: if a patient presents to labor and delivery at cabell huntington hospital and consents to the study, she will be randomized to either the icg directed therapy group or provider preference group. patients from each group will receive a non-invasive hemodynamic assessment via the nicas system. the nicas system uses impedance cardiography which provides a reliable assessment of cardiovascular, respiratory, and fluid parameters. the vasodilator nifedipine will be initiated for increased systemic vascular resistance. elevated cardiac output will be treated with beta blockade via iv labetalol. acog recommends either of these medications as first line therapy for elevated blood pressure, and offers no guidance on which medication should be used first. all patients who are being treated will receive the standard of care treatment, however the icg group will receive therapy based on their hemodynamic parameters. study analysis the control group will be compared to the icg directed treatment group.

Eligibility criteria:
inclusion criteria: * patients presenting to labor and delivery at cabell huntington hospital being treated for severe range blood pressure after 20 weeks gestation. patients will be english speaking and range in ages from 15-45 years old. patient's will be consented prior to randomization. exclusion criteria: * patients presenting to labor and delivery at cabell huntington hospital with normal range blood pressures, or those with elevated blood pressures who do not consent to the study, patients \<20 weeks gestation, or patients with eclampsia.
response shift and quality of life in patients suffering from schizophrenia and their caregivers

Conditions: Schizophrenia

Summary: quality of life (qol) measurements have become an important way to evaluate the treatments and care provided to patients with schizophrenia. understanding determinants of qol in schizophrenia is of importance for developing effective interventions that would improve patient functional and subjective well-being. a challenge in the interpretation of qol measures, especially in longitudinal studies, is that qol is self-reported by the patient and might be influenced by psychological phenomena such as adaptation to illness. an important mediator of this adaptation process is a "response shift" (rs), which involves changing internal standards, values and the conceptualization of qol. rs can be divided into three phases 1) reconceptualization (i.e., a redefinition of qol), 2) reprioritization (i.e., a change in the importance attributed to component domains constituting qol) and 3) recalibration (i.e., a change in a patient's internal standards of measurements). patients may change their frame of reference, rendering scores from different measurement occasions incomparable. an rs is a potential explanation when the qol of an individual who has experienced a serious health event or chronic condition is similar to the qol of a healthy individual. with an rs, the concept of qol changes over time and cannot be compared longitudinally because of changes in internal standards, values, and/or concepts. true change may be over- or underestimated when a rs is present, leading to biased estimates of the magnitude of change.the objective is to examine whether a response shift, a change in the internal standards of a patient, occurs in patients suffering from schizophrenia and in their caregivers. this is a monocentric and propective design study, with inclusion of patients and caregivers on a 12-month period, and a follow up on a 12-month period. 100 patients with schizophrenia and 100 caregivers test approach (response shift (rs) (pre-test - then-test), unadjusted effect (post-test - pre-test), and adjusted effect (post-test - then-test scores)) will be completed with other statistical approaches such as confirmatory factorial analysis, multilevel models and cart method.


Eligibility criteria:
inclusion criteria caregiver:: * person identified by the patient as the family member or friend who provided the most support or assistance, * informed consent obtained * being a native french speaker inclusion criteria patients: * suffering of schizophrenia according dsm iv, * informed consent obtained * being a native french speaker exclusion criteria: * patient suffuring of demencia
study : levobupivacaine versus placebo

Conditions: Pain

Summary: the locoregional anaesthesia is increasingly important in surgical practice, often allowing to simplify per- and post-operative analgesia. caesarian occurs in 20 % of delivery leading to a longer hospitalization because of the pain resulting from the surgery. the levobupivacaïne (chirocaïne) administered through catheters placed in the caesarean scars, showed its efficiency in post-operative analgesia. method : realization of a double blind prospective randomized study, control versus placebo purpose : to show that the local administration of a unique dose of analgesia reduce the post-operative pain with a little or non-invasive technique

the study will be done at the department of obstétric and gynecology, in the chu of saint-etienne. it will include all patients requiring a caesarean without any contraindication. all the patients requiring a urgent or a very urgent caesarean will be excluded because a rapid consent can't be obtained and the product preparation can't be done. inclusion after information and minimum one hour of time for consideration. randomization : the teatment group will be randomized according to the patient number : control versus placebo : 70 patients in the group infiltration of levobupivacaïne and 70 patients in the group infiltration of a placebo. every product will be prepared in a 30 ml syringe filled with levobupivacaïne or 0,9 % sodium chloride depending on the group of randomization. all patients will get their caesarean according to the same technique, then, before the cutaneous close, the product will be injected in the caesarean wall. fllow-up : supervision of the pain (morphine consumption, vas) and of undesirable effects.

Eligibility criteria:
inclusion criteria: * age \> 18 years * all patients requiring a non-urgent caesarian done according to the misgav-ladach technique exclusion criteria: * patients requiring very urgent caesarian * allergic to levobupivacaïne * with previous history of alcoholism or drug addiction * with severe hypotension or an ischemic cardiopathy badly compensated or thyrotoxicoses * treated with first generation of imao (monoamine oxidase inhibitor) or with anti-arrhytmia drugs with anesthesic activity

Keywords: randomized analgesic caesarean scars locoregional anaesthesia infiltration levobupivacaïne chirocaïne caesarian unique administration post-caesarian analgesic
polish transcatheter transfemoral mitral valve-in-valve implantation (mitral viv) registry

Conditions: Mitral Insufficiency; Mitral Stenosis; Mitral Stenosis With Insufficiency; Heart Failure; Bioprosthesis Failure

Summary: in recent years increasing number of mitral bioprosthesis implantation, especially in elderly population, is observed. bioprosthetic valves are associated with a lower risk of thrombotic and bleeding adverse events compared with mechanical prostheses, but their use is limited due to their durability. after years numerous patients may develop bioprosthesis failure, requiring valve reintervention. significantly burdened ones are oftentimes disqualified or not referred to surgery redo. an emerging treatment method for these patients is transcatheter mitral valve-in-valve implantation as an alternative to re-operation. this technique is applied with the use of devices previously dedicated to transcatheter aortic valve implantation (tavi). recent papers prove that transcatheter mitral valve replacement (tmvr) is a safe and effective procedure when performed in a selected group of high-surgical-risk patients. however, data regarding the polish population are limited. therefore, the aim of the study is to create a nationwide registry, collecting data from all polish centers performing tmvr in order to describe the population of patients developing mitral bioprosthesis failure, evaluate their follow-up after tmvr as well as results of the transcatheter valvular intervention and identify potential limitations of the procedure.


Eligibility criteria:
inclusion criteria: * failing surgically implanted mitral bioprosthetic valve demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency * qualification for tmvr by decision of the local heart team * patient provided written informed consent exclusion criteria: - disqualification from tmvr

Keywords: transcatheter mitral valve replacement transcatheter mitral valve implantation mitral valve-in-valve mitral valve insufficiency mitral stenosis mitral regurgitation bioprosthesis failure left ventricle outflow tract obstruction
task-oriented arm/hand skill rehabilitation and therapy dose dimensions in subacute spinal cord injury rehabilitation

Conditions: Spinal Cord Injuries

Summary: the study is a multicenter longitudinal observational study. the therapy content and the therapy dosage of arm/skill training for patients with cervical spinal cord injury (sci) will be observed for the primary objective. the aim is to get insight into the current therapy content and the current therapy dosage in arm/hand skill training, with the overall aim to optimize the arm/hand skill training. for the secondary objective, in addition to the patients with cervical sci also, patients with paraplegia as a result of sci are included. the aim is to assess the difference between the patient's perceived dose and the therapist's estimation of the therapy dose. this will give insight into the patient's and therapist's views on therapy dose; this information will contribute to optimizing therapy dose in exercise therapy in sci. the third aim is a pilot study to explore the usability of evening reports in sci rehabilitation.


Eligibility criteria:
inclusion criteria: * primary objective 1. have sustained a traumatic or non-traumatic sci between c1 and t1. 2. have an ais a, b, c or d 3. are older than 16 years 4. being able to follow standard arm/hand skill training. 5. patients in the subacute phase (4-30 weeks post-injury) 6. receiving usual care 7. able to understand the purpose of the study (understanding dutch, english, french and german). * secondary objective add patients with: 1. persons with sci (c1-s4) 2. having an ais a, b, c, d; 3. are older than 16 years; 4. patients in the subacute phase (4-30 weeks post-injury) 5. receiving standard care or more intensive care as defined by the sci-mt trial - therapists physiotherapists, occupational therapists and sports therapists with at least two years of experience in sci rehabilitation exclusion criteria: 1. have any significant medical or physical condition (including pregnancy) or psychiatric illness that could prevent the person from participating in the study 2. are unable/unwilling to provide informed consent.

Keywords: spinal cord rehabilitation therapy content in arm/hand skill training therapy dose in spinal cord rehabilitation
lci-sar-bsts-ctdna-001: circulating tumor dna liquid biopsy in sarcoma patients

Conditions: Sarcoma

Summary: the purpose of this research study is to see how well low pass whole genome sequencing (lp-wgs) can detect circulating tumor deoxyribonucleic acid (ctdna) in the blood of participants who have bone or soft tissue sarcoma (type of cancer).

in this ever-expanding age of precision oncology, the stagnant treatment algorithms and subsequent oncologic outcomes for sarcoma patients highlight the need for novel technologies to help clinicians treat these patients. while countless prognostic and therapeutic molecular biomarkers have been identified for many other cancers, sarcoma practitioners have strikingly few tumor markers to guide treatment. the development of a sarcoma-specific liquid biopsy could greatly help clinicians with diagnosis, prognostication, treatment response, minimal recurrent disease, and recurrence. the purpose of this study is to clinically evaluate ctdna liquid biopsy approaches in adult and pediatric patients with bone and soft tissue sarcomas.

Eligibility criteria:
inclusion criteria: 1. written informed consent or assent when applicable from the participant, lar, parent or legal guardian and hipaa authorization for release of personal health information. 2. all ages allowed 3. suspected or confirmed disease (must meet one of the criteria below): 1. suspected bone or soft tissue tumor concerning for sarcoma (pending confirmation of sarcoma diagnosis) or 2. suspected lipomatous mass concerning for alt or wdls with planned surgery or 3. confirmed bone or soft tissue sarcoma meeting one of the criteria below: * non-metastatic/resectable sarcoma with either planned or currently receiving therapy * metastatic or unresectable sarcoma, with planned or currently receiving therapy * non-metastatic sarcoma under surveillance with no more than 1 year from completion of therapy exclusion criteria: * none

Keywords: circulating tumor dna liquid biopsy bone or soft tissue sarcoma
study on the relationship between chinese women's perinatal mental health and socioeconomic status

Conditions: Mental Disorders During Pregnancy; Mental Disorder in the Puerperium - Baby Delivered

Summary: the objective of this study is to explore the relationship between perinatal women's mental health and socioeconomic status, observe the perinal outcomes of different income level, and make mental health reference value for them. questionaires will be used to investigate women's income and mental health status in 4 periods, including the first, second, third trimester and postpartum 42 days. after delivery, birth outcomes will be collected from participating hospitals' clinical case system. all data will be analysed with statistical software.

the objective of this study is to explore the relationship between perinatal women's mental health and socioeconomic status, observe the perinal outcomes of different income level, and make mental health reference value for them. several hospitals from 5 provinces located in the est, west, south, north and middle of china will participate in the study which plans to include 5000 pregnant women. questionaire will be used to investigate women's income and mental health status in 4 periods, including the first, second, third trimester and postpartum 42 days. after delivery, birth outcomes will be collected from participating hospitals' clinical case system. all data will be analysed with statistical software.

Eligibility criteria:
inclusion criteria: * must be able to read and understand informed consent; age 18-59; singleton in 12-14 gestational weeks; plan to give bith in participating hospital; must be able to comply with study regulations; exclusion criteria: * unmarried women; multiple-pregnancy; clinical diagnosis of mental disorders before;

Keywords: mental health socioeconomic status
correlation of the objective and subjective measures of the nasal obstruction before and after surgery of the nasal septum

Conditions: Nasal Obstruction

Summary: nasal obstruction is a very subjective sensation but it's also a frequent reason of consultation. two specific questionnaire nose and rhinoqol were validated; but rhinomanometry value is still a question to debate. as well as the difference between acoustic rhinometry and rhinomanometry. usually nasal obstruction due to a septal deviation is treated by septoplasty. if the anatomic result can be proved true, the patient's felt would be unsuccessful. the aim of this study is to assess the impact of septoplasty on the nasal obstruction, objectively by rhinometry and subjectively by questionnaire.


Eligibility criteria:
inclusion criteria: * age \>18 * with medical insurance * programmed for septoplasty * nasal obstruction with septal deviation * accept participation exclusion criteria: * nasal sine polyposis * endonasal mass * chronic sinusite * previous nasal surgery
parecoxib in post surgery (hemicolectomy) pain

Conditions: Colectomy

Summary: this is a phase iii, multicenter, open label, pilot to evaluate the analgesic efficacy and safety of parecoxib 40 mg iv in the treatment of the pain following hemicolectomy in an optimal management of the surgical patient

the study was terminated prematurely due to recruitment issues on 31 january 2006. safety concerns did not lead to the decision to terminate this study.

Eligibility criteria:
inclusion criteria: * patients hospitalised for resection of left/right colon; * preoperative health graded as asa \<3. exclusion criteria: * patients with any type of metastatic cancer, particularly metastatic colon cancer; * patients with familial adenomatous polyps (sporadic adenomatous polyps are accepted);
continuous versus interval walking training in patients with copd - a pilot study

Conditions: Chronic Obstructive Airway Disease

Summary: this study will investigate the effects of interval walking training versus continuous walking training in patients with chronic obstructive pulmonary disease. patients will be recruited during a 3-week inpatient pulmonary rehabilitation program and will be randomized to one of the two intervention groups. all walking training sessions will be performed on the same treadmill. walking intensity in the continuous walking group will be 60 percent of the average speed of the 6-minute walking test. patients in the interval training group will perform high intensity intervals at 120% of the 6-minute walking test speed for 60 seconds alternating with 60 seconds of rest. the total exercise duration will be progressively increased from 10 to 32 minutes.


Eligibility criteria:
inclusion criteria: * copd stage iii or iv according to the global initiative for chronic obstructive lung disease \[gold\] * stationary patient in the schön klinik berchtesgadener land exclusion criteria: * acute, severe exacerbation of copd * failure to comply with study process

Keywords: chronic obstructive pulmonary disease endurance training interval training continuous training walking training
third dose of moderna covid-19 vaccine in transplant recipients

Conditions: Vaccine Response Impaired; Immune Suppression; Covid19

Summary: this study will be a randomized, double-blind, placebo-controlled trial of a third dose of moderna vaccine versus placebo. participants will be those that have received two doses of mrna-1273 covid vaccine (moderna) at 0 and 1 months. participants will be randomized 1:1 to receive either a third dose of the mrna-1273 vaccine or saline placebo at 3 months post initial vaccination.

solid organ transplant (sot) recipients are at high risk of covid-19 complications. the moderna vaccine (mrna-1273) has proven highly efficacious and safe in a phase iii large, randomized controlled trial of 30,420 persons in the general population, and has been in use in canada since december 2020. sot patients show diminished response to mrna vaccines in several studies with approximately 40-50% positive antibody after the second dose. in positive patients, antibody titers are lower than the general population and adverse events mirror the general population. the current study will recruit 120 sot recipients who have received both scheduled doses of the moderna vaccine at 0 and 1 months. the hypothesis is that a third dose of vaccine will significantly increase antibody titers. sot participants will be recruited and randomized 1:1 to receive an additional dose of moderna covid-19 vaccine two months after the last dose vs saline placebo. the outcomes will measure anti-rbd antibody titer, t-cell immunity, local/systemic side effects, and rejection events.

Eligibility criteria:
inclusion criteria: * solid organ transplant recipient who has previously received moderna vaccine at 0 and 1 months * able to provide informed consent exclusion criteria: * anaphylaxis or allergic reaction to moderna vaccine

Keywords: solid organ transplant vaccine
investigating the possible link between habitual diet, physical activity, sleeping patterns, obesity status and age with gut bacterial composition, gut barrier function, metabolic endotoxemia, systemic inflammation and glycaemic control.

Conditions: Obesity; Metabolic Syndrome; Insulin Resistance

Summary: in the uk, 25% of the adults are affected by metabolic syndrome (nhs, 2016). metabolic syndrome is a cluster of different conditions including: hyperglycaemia, insulin resistance hypertriglyceridemia, dyslipidaemia and hypertension. such individuals also have increased risk of developing type 2 diabetes and cardiovascular disease. the factors contributing to the development of metabolic syndrome are potentially numerous and understudied in humans, with much of what we think we know coming from animal research. recent animal studies have pointed towards gut health playing a role in metabolic health. more specifically it has been suggested that changes in the composition of the gut microbiota may drive insulin resistance and type 2 diabetes through a mechanism that is linked to increased gut permeability and the development of metabolic endotoxemia and inflammation. yet, this link has not been confirmed in humans. this research will look at the relationship between diet, physical activity, sleeping patterns, obesity status and age etc. and measures of gut bacterial composition, gut barrier function and metabolic health. findings will provide us with new insights on the effect of different physiological and behavioural/ lifestyle variables on gut health and metabolic function.


Eligibility criteria:
inclusion criteria: * men and women aged 18-70 years * bmi 18.5-50 kg/m2 * not taking antibiotics and antimicrobial drugs for at least three months * both physically active and sedentary individuals will be eligible to take part in the study * weight stable (±5kg) for at least 6 months excusion criteria: * no cardiometabolic (e.g. heart disease, high blood pressure) or inflammatory illness * smokers (including the use of vaporisers and e-cigarettes) * taking anti-inflammatory drugs (excluding aspirin)

Keywords: glycaemic control gut permeability gut microbiota metabolic endotoxemia metabolic health