Kornimate/medical-research-clean huggingface dataset:
home non-invasive ventilation targeting expiratory flow limitation in severe hypercapnic copd.

Conditions: COPD

Summary: in this 2-phase pilot study, the bipap a40 efl will be evaluated in patients with severe copd requiring home non-invasive ventilatory support with respect to patient-related and physiologic outcomes.

objective phase 1: in patients with copd already established on home niv, to assess the effect of 2 months of the a40efl on ventilator parameters, physiologic and patient-related outcomes (pro), in comparison to the patients' usual settings as prescribed by their treating physician. the two primary outcomes will be the nightly duration of niv use and niv-related symptoms (s3-niv questionnaire). patient preference will be a secondary outcome. objective phase 2 : in hypercapnic patients with copd with a prior hypercapnic exacerbation requiring niv in hospital, to obtain preliminary data regarding the impact of home niv using the a40efl on copd exacerbations and physiologic and patient-related outcomes. the primary outcome will be the number of hospitalizations over 12 months on a40efl. secondary outcomes will include descriptive data on number of exacerbations not requiring hospitalization but treated with antibiotics or prednisone. additional secondary outcomes, physiologic and pro, for both phases 1 \& 2, will be evaluated.

Eligibility criteria:
inclusion criteria: * phase 1: severe copd with fev1\<50%, using home niv successfully for at least 2 months through the quebec national program for home ventilatory assistance (nphva). * phase 2: severe copd with fev1\ = 52 on arterial or capillary blood gas measured 2-4 weeks after acute niv use and discontinuation exclusion criteria: * phase 1 copd exacerbation requiring treatment (including hospitalization) within the last 6 weeks; surgical procedure or major illness within the last 3 months; kyphoscoliosis, neuromuscular disease, other lung disease (e.g. fibrosis); active cancer; expected survival \< 2 months; listed on the transplant list. * phase 2: any additional condition potentially predisposing to hypercapnia such as: obesity (bmi\> 30kg/m2), kyphoscoliosis, neuromuscular disease, other lung disease (e.g. fibrosis), severe obstructive sleep apnea (ahi\>30/h on prior testing if available, but will not test as part of the study); active cancer; expected survival \< 2 months; listed on the transplant list at start of study.
efficacy of cpap treatment on blood pressure of resistant hypertension patients with obstructive sleep apnea syndrome

Conditions: Obstructive Sleep Apnea Syndrome; Resistant Hypertension

Summary: the aim is to evaluate the effect of treatment with continuous positive airway pressure (cpap) device on clinic and ambulatory blood pressures (bp) of 200 resistant hypertensive patients with moderate-severe obstructive sleep apnea syndrome (osas).

obstructive sleep apnea syndromes (osas) have been demonstrated to be highly prevalent in patients with resistant hypertension (defined as uncontrolled clinic bp despite being on anti-hypertensive treatment with at least 3 drugs in optimal doses and including a diuretic). nevertheless, the effect of treating osas with continuous positive airway pressure (cpap) device on clinic and ambulatory bps in patients with resistant hypertension is largely unknown. hence, the primary aim of this randomized clinical trial is to evaluate the effect of cpap on bp levels in resistant hypertensive patients with moderate-severe osas (defined as an apnea-hypopnea index \[ahi\] greater than 15 on a full polysomnographic examination). two-hundred patients will be randomly allocated either to treatment with cpap device plus their usual anti-hypertensive treatment or to continue their usual treatment alone for 6 months. clinic and 24-hour ambulatory bp monitoring, laboratory evaluation (including microalbuminuria and aldosterone-to-renin ratio), 24-hour holter monitoring, ergospirometric treadmill test, and carotid-femoral pulse wave velocity measurement will be performed before and after the 6-month treatment, with the observers blinded to the allocation group.

Eligibility criteria:
inclusion criteria: * patients with resistant hypertension and moderate-severe obstructive sleep apnea syndrome exclusion criteria: * older than 80 years * pregnant women * non-adherent to anti-hypertensive treatment * severe cognitive deficits

Keywords: continuous positive airway pressure ambulatory blood pressures
crp-guided transanal drainage removal after rectal surgery

Conditions: Rectal Cancer; Anastomotic Leak

Summary: transanal drainage tube (tdt) has the benefit of reducing intraluminal pressure after rectal surgery and may provide ideal regional environment for anastomotic healing. postoperative c-reactive protein (crp) trajectory has a high negative predictive value of 0.99 for ruling out anastomotic leak (al). previously, tdt was removed at the surgeon's own discretion. in the present study, we design a single arm study to investigate the safety and efficacy of crp-guided tdt removal for al prevention following laparoscopic anterior resection for rectal carcinoma


Eligibility criteria:
inclusion criteria: * age from 18 to 75 years old * male and female * primary rectal adenocarcinoma * asa i, ii, or iii * laparoscopic lar + dst * with or without preoperative radio- or chemotherapy * no distal metastasis * no preoperative bowel obstruction * no preventive ileostomy or colostomy * patients and their families can understand and are willing to participate in this study and provide written informed consent exclusion criteria: * emergency operation * preoperative abnormal liver function * tatme or isr procedure (healing process might differ from anterior resection) * severe postoperative (clavien-dindo grade iii iv v) complications other than anastomotic leak * severe perioperative infection unrelated to anastomotic leak * patients with serious mental illness * pregnant or breastfeeding women * patients with other clinical and laboratory conditions considered by the investigator should not participate in the trial
spinal cord injury neurorecovery collaboration

Conditions: Spinal Cord Injuries

Summary: scinc is an adaptive design master protocol that seeks to determine if there is "sufficient promise" of beneficial effect of treatment combinations to enhance motor recovery in pre-specified strata of people with a spinal cord injury.

scinc utilises an adaptive design with interim analyses to assess whether a given intervention is futile or shows a "signal of benefit" within an appendix-specific study. the scinc master protocol describes trial procedures, data collection, data monitoring, follow-up visits, and safety procedures that will be employed in all study-specific appendices. the study-specific appendix is a bayesian optimised phase iia trial, operating under the overarching scinc master protocol. the first study-specific appendix is: restoration of respiratory and upper limb function after cervical spinal cord injury (rruli): therapeutic intermittent hypoxia (tih) + exercise training (et). the rulli: appendix 1 (tih + et) aims to determine if et plus tih in people with chronic tetraplegia is a therapy with sufficient promise to test in a phase iib/iii trial; considering feasibility, safety and efficacy. as new interventions are put forth, they will be added to the master protocol as a new appendix. this master protocol describes trial procedures, data collection, data monitoring, follow-up visits, and safety procedures that will be employed in all study-specific appendices. each study-specific appendix will have a process evaluation protocol.

Eligibility criteria:
scinc inclusion criteria: - person with sci scinc exclusion criteria: - proven contraindication to intervention rruli: appendix 1 (tih + et) study-specific inclusion criteria: * adults \> 18 years of age * able to independently ventilate * chronic sci (\>1 years post-injury or impairment onset) * tetraplegia (c2-t1 level of injury) * evidence of motor incomplete paralysis in the upper limb below the neurological level of injury * have a documented management plan for their ad if it occurs. rruli: appendix 1 (tih + et) study-specific exclusion criteria: * pregnancy * medical instability, including current or recent (within the previous 6 weeks) infection or inflammation * current or recent (within the previous 6 weeks) pressure ulcers or cutaneous lesions * poorly controlled diabetes * an episode of ad in the previous 6 months that required medical intervention to resolve * significant other neurological, psychiatric, pulmonary, cardiovascular, orthopaedic, or oncological conditions. * currently taking part in another clinical trial * upper limb contracture
new-onset chronic pelvic pain in transgender people using testosterone therapy: an exploratory qualitative study.

Conditions: Transgender Persons; Pelvic Pain; Testosterone; Gender-Affirming Care

Summary: this descriptive qualitative study aim to describe the characteristics of pelvic pain in transgender (trans) individuals using testosterone therapy and the impact on their quality of life. this study also aim to understand the levers and obstacles to consulting a health care professional.

this study ai to accurately describe the chronic pelvic plan (cpp) from which transmasculine people can suffer, as well as their impact on quality of life, and to understand what are the obstacles and levers to the implementation of adapted care. method: it is an observational, single-center, qualitative study. 10 to 15 trans individuals using testosterone therapy and having pelvic pain for at least 6 months, and that had appeared or changed since taking testosterone, will undergo a semi-structured interview. they will be recruited through community care associations, mailing lists and flyers. results: this is a qualitative study aimed at accurately describing the symptoms of pelvic pain experienced by trans people thus we will do a qualitative analysis. qcamaps will be used for the coding step.

Eligibility criteria:
inclusion criteria: * being a trans masculine individual * taking a gender affirming hormonal therapy (gaht) * living close to grenoble * having pelvic pain that appeared or were modified after taking gaht exclusion criteria: * subject under guardianship or subject deprived of liberty refusal of voice recording
continuous glucose monitoring for various degrees of glucose intolerance

Conditions: Diabetes, Gestational

Summary: diabetes mellitus affects roughly 8% of pregnancies but is associated with significant perinatal and maternal morbidity, with 6% of pregnancies affected by gestational diabetes mellitus (gdm). best practice guidelines recommend universal screening for gestational diabetes mellitus between 24-28 weeks of pregnancy in all women who do not have a diagnosis of pre-gestational diabetes mellitus. among high-risk populations, performing an early diabetes screen is suggested at the initiation of prenatal care to evaluate for pre-gestational diabetes mellitus. prior studies have demonstrated a difference in perinatal outcomes by comparing women with negative screening tests to those who fail a screen but pass a diagnostic test and those who are ultimately diagnosed with gdm. the investigators aim to use continuous glucose monitoring systems to study glycemic control in the early third trimester to further elucidate the differences between pregnant women with euglycemia, glucose intolerance, and gdm.


Eligibility criteria:
inclusion criteria: * age 18-45 years * women with a viable singleton or twin intrauterine pregnancy between 24 0/7 and 31 6/7 weeks gestation based on the best obstetric estimate by acog criteria * planning to deliver at osu wexner medical center * able to understand the study, and having understood, provide written informed consent in english exclusion criteria: * abnormal early 50g gct screen, thereby necessitating 100g ogtt at 24-28 weeks * known pregestational diabetes (type 1, type 2, mody) * 50g gct \>200 mg/dl leading to gdm diagnosis without the performance of 3hr 100g gtt * abnormal obstetrical ultrasound suspicious for major congenital abnormality * known or suspected fetal aneuploidy (by either cvs, amniocentesis, or cell-free dna) * participation in another trial that may influence the primary outcome, without prior approval * participation in this trial in a prior pregnancy * higher order pregnancy
evaluation of pain with radiesse® with lidocaine for nasolabial folds

Conditions: Nasolabial Folds

Summary: to assess pain during nasolabial fold treatment using radiesse® injectable dermal filler with lidocaine

to assess pain immediately after nasolabial fold treatment with radiesse® injectable dermal filler with lidocaine in one nasolabial fold compared to radiesse® injectable dermal filler without lidocaine in the contralateral nasolabial fold

Eligibility criteria:
inclusion criteria: * is at least 18 years of age * is a candidate for nasolabial fold treatment using radiesse * has approximately symmetrical nasolabial folds * understands and accepts the obligation not to receive any other facial procedures in the lower half of the face for 1 month exclusion criteria: * has received any type of treatment or procedures including surgery in the nasolabial folds * has received neurotoxin, hyaluronic acid, calcium hydroxylapatite (caha) or collagen injections in the lower half of the face within past 6 months * has received polylactic acid, polymethyl methacrylate (pmma), silicone or any other permanent filler in the lower half of the face * has nasolabial folds that are too severe to be corrected in one treatment session * has any history of hypersensitivity to lidocaine or anesthetics of the amide type

Keywords: moderate to severe wrinkles and folds such as nasolabial folds
influence of enteral microbiome on mortality of patients with cardiogenic shock

Conditions: Cardiogenic Shock; Microbial Colonization; Out-Of-Hospital Cardiac Arrest; Acute Heart Failure; Acute Myocardial Infarction

Summary: cardiogenic shock is associated with a high mortality. the microbiome is a double-edged sword which can convey protective and detrimental cardiovascular effects. the significance of the enteral micobiome on cardiovascular mortality of patients with cardiogenic shock is still not known. this study aims to provide a deeper understanding of the role of the enteral microbiome and microbiome dependent metabolites in mortality and disease progression of patients with cardiogenic shock.


Eligibility criteria:
inclusion criteria: * \>18y * signs of cardiogenic shock regardless of etiology * lactate \>3mmol/l * and signs of organ dysfunction (urine output \<30 ml/h, cold extremities, altered mental status) * and systolic blood pressure \ 30 minutes or need for vasopressor therapy exclusion criteria: * pregnancy/lactation period * antibiotic treatment within \>24h * chronic inflammatory bowel disease * short bowel syndrome * artificial bowel outlet * persistent diarrhea or vomiting in the past 3 months * simultaneous participation in another interfering nutrition study * active chemo or radiation therapy
the ready-to-eat meals for cardiovascular health study

Conditions: Diet; Hypertension; Cardiovascular Diseases; Blood Pressure

Summary: the proposed project explores the acceptability and health benefits of ready-to-eat (rte) meals based on the dietary approaches to stop hypertension (dash) eating plan. the researchers have developed 14 recipes following the dash eating plan, which is recommended for the prevention of cardiovascular disease (cvd). the prepackaged meals will be processed using washington state university (wsu) microwave technologies to ensure food safety. in this pilot study, a sample of 30 participants will be recruited by to study the impact of the dash meals on blood pressure. all meals will be provided to participants, who will consume the meals daily over a period of 4 weeks. daily and weekly monitoring of participants (blood pressure and weight) will allow us to gain a scientific understanding on the preventive power of healthy diets in lowering blood pressure and reducing cvd risk.


Eligibility criteria:
inclusion criteria: * male or female * 18 years old or older * bmi 18.5-40.0 kg/m2 * daily access to working internet, microwave, refrigerator, and freezer * english fluency exclusion criteria: * regular use of drugs that affect bp, including weight loss medications * diagnosed hypertension or systolic bp \>130 and/or diastolic bp \>80 * diagnosis of any hypotensive disorders or systolic bp \<100 and/or diastolic bp\<65 * dietary restrictions, including allergy/intolerances * presence or history of diabetes * previous cardiac event, congestive heart failure, or angina * weight loss or gain\>15lb in previous 3 months * following a diet to increase or decrease body weight * cancer diagnosis or treatment in past 2 years * ≥14 alcoholic drinks/week for men; ≥ 7 alcoholic drinks/week for women * use of nicotine, marijuana, or illicit drugs * pregnancy, planned pregnancy, or breastfeeding * inability to comprehend the nature of the study or instructions * no access to the internet * planning to leave the spokane area during the study * not fluent in the english language

Keywords: dash dietary approaches to stop hypertension meals high blood pressure hypertension
what is the future of vulnerable new-borns

Conditions: Preterm Birth

Summary: the aim of this data base is to know exactly the future of a "vulnerable newborns" cared in pontoise hospital (in the neonatology service) and compare the information with the national data of preterm birth.

the aim of this data base is to know exactly the future of a "vulnerable newborns" cared in pontoise hospital (in the neonatology service), it means, newborns who are in these following risk categories: * birth before 33 weeks of amenorrhea * birth between 33 and 36 weeks of amenorrhea and fetal growth retardation lower to the 3rd for the gestation age * perinatal anoxic-ischemia * other children whose birth, perinatal history or the existence of a pathology classified them in a category at risk of developmental psychomotor disorders, the co-twin of a child of the preceding groups. * a regular follow-up is made in pontoise hospital till the age of 7 to 8 year sold. it tries to screen growth anomalies (neuromotor, sensorial, behavioral, and cognitive or growth development) or health status. the data collect allow us to monitor these parameters and do a statistical study with them. these information may be used to inform the parents about the future of the premature children cared at pontoise. they also may be used to compare these children's future with the national data (epipage 2)

Eligibility criteria:
inclusion criteria: * birth before 33 weeks of amenorrhea * birth between 33 and 36 weeks of amenorrhea and fetal growth retardation lower to the 3rd percentile for the gestational age. * perinatal anoxic-ischemia other children whose birth, perinatal history or the existence of a pathology classifies them in a category at risk of developmental psychomotor disorders, the co-twin of a child of the preceding groups. exclusion criteria: * children born in normal conditions.

Keywords: preterm birth; growth; neonatology; pregnancy; delivery
frequent dialysis & markers of cardiac strain and injury, physical fitness, habitual physical activity & quality of life

Conditions: Kidney Failure

Summary: individuals with kidney failure are kept alive using dialysis machines designed to remove toxic substances and excess fluid from the blood. standard dialysis is undertaken three times a week at a dialysis unit, supported by a team of specialist dialysis nurses (so called in-centre haemodiafiltration or ichdf). each session lasts approximately 4 hours, during which time the fluid and toxins which have built up since the last session of treatment are removed from the blood. the rapid removal of fluid that takes place using this technique often causes unpleasant symptoms such as cramps and dizziness, as well as a "hangover", which may last several hours. it can also cause problems with the heart in the long-term. in recent years, individuals requiring dialysis have been able to choose between standard ichdf or having haemodialysis at home (hhd) using a convenient table top machine called nxstage system one. this device is used more frequently than in ichdf and for shorter sessions. as a result, the amount of fluid removed during each session is less than with ichdf. this may be beneficial to the heart, but may also make these individuals feel generally better, which may make them want to be more physically active. it may also reduce the time taken to recover from any symptoms experienced after dialysis. over a 12 month period, markers of heart damage (using blood tests and scans of the heart) in patients receiving frequent hhd will be studied and the results will be compared with a group of patients receiving ichdf. the study will also compare any symptoms they may have, how fit they are, how physically active they are and how well they sleep. in addition, the investigators will assess how well fluid balance is maintained in each group and measure the changes in their remaining kidney function during this time.


Eligibility criteria:
inclusion criteria: * receiving hhd or ichdf for more than 3 months and less than 36 months. * haemoglobin equal to or greater than100 g/l at enrolment. * willing and physically able to undertake the study assessments/tests * willing to provide blood for storage and future analysis * able to give informed consent exclusion criteria: * living donor transplant or change to peritoneal dialysis planned * physical assessments contraindicated for the following clinical reasons * acute coronary syndrome (acs) within the last 3 months (chest pain, ecg changes or typical biomarker elevation). * any current uncontrolled cardiac dysrhythmias causing symptoms (chest pain, palpitations, syncope or dizziness) * symptomatic aortic stenosis * new york heart association grade iv heart failure * severe chronic obstructive pulmonary disease * acute pulmonary embolus or pulmonary infarction in the last 3 months * current acute myocarditis or pericarditis * suspected or known dissecting aneurysm * acute systemic infection, accompanied by fever, body aches or swollen lymph glands * pregnancy * life expectancy of less than twelve months
weighted blankets for postsurgical pain

Conditions: Pain, Postsurgical

Summary: the strongest psychological predictor of persistent pain after surgery is anxiety before surgery. the weight of blanket a person uses overnight may alter both anxiety and pain levels. the proposed study will determine whether a heavier or lighter blanket alters presurgical anxiety or postsurgical pain in individuals undergoing a breast surgery. we will also study whether any blanket-induced changes in postsurgical pain are related to reductions in anxiety before surgery induced by the blanket. finally, we will examine clinical and psychological factors that might explain differences in how surgical patients respond to blanket weight. this research will improve our understanding of whether blanket weight can alter anxiety before a surgery or pain after a surgery.


Eligibility criteria:
inclusion criteria: * fluent in english * undergoing breast surgery * willing to sleep with a weighted blanket for up to 3 months * bmi of at least 18.5 and able to safely lift up to 15lb * willing and able to use their personal smartphone for the ecological momentary assessment app to submit ratings using personal data plan exclusion criteria: * pregnancy * chronic high-dose opioid use * current or previous use of a weighted blanket * claustrophobia * incarceration

Keywords: mastectomy anxiety blankets