Kornimate/medical-research-clean huggingface dataset:
ascertaining longterm outcomes of fibroid treatments

Conditions: Uterine Fibroid

Summary: the goal of the aloft study is to understand the health of women in the 12 years following a uterine fibroid (uf) treatment. aloft is a multi-center, prospective, observational cohort study of approximately 700 women who have undergone uterine-sparing treatment procedures for uf and previously participated in the longitudinal studies compare-uf (nct02260752) or ultra (nct02100904). the primary uterine sparing treatment procedures undergone by study participants are myomectomy, endometrial ablation (ea), uterine artery embolization (uae) and laparoscopic radiofrequency ablation (rfa). a smaller number of women may be studied who underwent focused ultrasound, intrauterine device (iud), and medical management. two follow-up study contacts with compare-uf and ultra participants will occur to assess changes in uf symptoms and treatment failure which is defined as the need for another uf treatment procedure. questionnaires will be used to collect data on patient-reported characteristics and outcomes and quality of life. the study's analyses will focus on comparisons of primary and secondary outcomes among women.


Eligibility criteria:
inclusion criteria: * participant has to have been enrolled in either the compare-uf or ultra study * participant had a uterine-sparing fibroid treatment at enrollment in compare-uf or ultra study exclusion criteria: * individuals who were not consented into the original compare-uf or ultra study * individuals who did not have a uterine-sparing fibroid treatment at enrollment in compare-uf or ultra study

Keywords: uterine fibroid treatment multi-center, prospective, observational cohort study uterine-sparing treatment procedures patient-reported outcomes quality of life
the effects of two brands of hydrocortisone injected intramuscularly into deltoid and thigh muscles

Conditions: Addison's Disease

Summary: the study will be looking at the cortisol profiles of hypocortisolaemic patients following 100mg injections of two hydrocortisone preparations (solu-cortef® \& hydrocortisone 100mg/ml). the investigators plan to use two methods of intramuscular injection to administer the preparations, one using a 1inch orange needle into the deltoid muscle and the other using a 1.25inch blue needle into the thigh muscle.


Eligibility criteria:
inclusion criteria: 1. age 18-70 inclusive 2. written informed consent provided, prior to any study related assessments/procedure being conducted. 3. men \& women with a bmi between 18-30kg/m2 4. addison's disease or bilateral adrenalectomised patients with pre-hydrocortisone cortisol level below 100nmol/l and acth greater than 50ng/l on screening visit 5. all patients must be stabilised on hydrocortisone with no change in dosage for 6 months, other than transient increases for concurrent illness. 6. able to self-inject into deltoid and thigh muscles following teaching at recruitment. 7. female patients of child-bearing potential must be willing to use an acceptable method of birth control/abstinence from the time consent is signed until 6 weeks after treatment is discontinued. acceptable methods include: physical barrier (male or female condom, contraceptive sponges, diaphragms and cervical caps),-contraceptive pill or patch, spermicidal method alongside a physical barrier or an intrauterine device (iud). abstinence is also acceptable if it falls in line with the patient's usual lifestyle however it must be complete abstinence and not either; periodic, ovulation timed, symptothermal or withdrawal based. those patients that utilise hormonal contraceptives must have used the same method for at least three months before additional barrier contraception (as described above). patients of non-child-bearing potential are defined as having 12 month amenorrhoea or are surgically sterile. exclusion criteria: 1. patient on oestrogen based or mixed oral contraceptives unless willing to use alternate effective method of contraception 2. patient on any forms of oral steroids other than hydrocortisone. 3. any patient with secondary adrenal failure 4. patients with a diagnosis of any disease or condition listed in hydrocortisone 100mg/ml and solu-cortef®'s smpc as being contraindicated or precautionary for use 5. patient with concurrent illness in the week preceding screening/study visit. 6. patient must not have had an adrenal crisis in the week before screening 7. patient with nelson's syndrome. 8. participating in another imp investigation 9. patient who is unable or unwilling to comply with the protocol. 10. patient taking any medications/substances that are known to interact with hydrocortisone e.g. cyp3a4 inhibitors 11. pregnant or breastfeeding patients 12. patient has any other disease or condition that, in the opinion of the investigator, might compromise patient safety or interfere with the results of the trial
evaluation of programs of reeducation for urinary incontinence in woman

Conditions: Urinary Incontinence

Summary: the objective of this study is to compare two methods of pelvic floor muscle training: reference method versus cmp ® method ( (connaissance et maîtrise de périnée : knowledge and control of perineum)


Eligibility criteria:
inclusion criteria: * patients more than 18 years old and less than 75 years * patients presenting an urinary incontinence of effort or mixed symptomatic associated with a pelvic statics disorder * patients with a perineale reeducation prescription * patients affiliated to a national insurance scheme or benefiting from such a program * patients having given her written consent form exclusion criteria: * nulliparous woman * patients already operated for their incontinence * patients with a prolapse of higher level at the stage ii of the classification pop-q (pelvic organ prolapse quantification) * pregnant women * patients presenting an associated anal incontinence, * patients presenting a cancellation (section of marrow, syringomyelia for example) or an inversion of perineum control * patients having given birth less than 6 months before the care * patients having benefited from a pelvi-périnéale reeducation in the previous 12 months, * patients presenting psychiatric disease * patients presenting a vaginismus, * patients presenting a contraindication to the practice of the electrostimulation.
neoadjuvant chemotherapy for locally advanced gall bladder cancer : a randomized control trial (neogb)

Conditions: Gall Bladder Carcinoma

Summary: to study role of chemotherapy treatment for gall bladder cancer before surgery as compared to surgery directly

gallbladder cancer is a highly aggressive disease with a late presentation and poor prognosis. complete surgical excision remains the only potentially curative treatment for early-stage gallbladder cancer. the use and benefit of chemotherapy in gallbladder cancer before surgery , that is , in the neoadjuvant setting, is not well studied and, to our knowledge, neoadjuvant chemotherapy has not been evaluated in any randomized clinical trial. neoadjuvant chemotherapy aims to achieve tumor downstaging, increase the radical surgical resection rate, reduce metastases. this study will compare the effectiveness of chemotherapy before surgery in locally advanced gall bladder cancer versus upfront surgery with respect to survival and completeness of resection of disease.

Eligibility criteria:
inclusion criteria: * ecog 0-2 * locally advanced resectable gbc defined as clinical t3/4 disease or regional ln involvement on imaging studies. * post cholecystectomy gbc with residual disease on imaging, history of bile spillage during primary surgery , history of piece-meal removal of gall bladder during simple cholecystectomy, regional ln involvement on imaging studies. exclusion criteria: 1. early gbc ( ct1/t2) without significant lymphadenopathy or liver infiltration on radiological imaging . 2. locally advanced disease requiring major hepatectomy or whipple's pancreatoduodenectomy. 3. post cholecystectomy gbc without any evidence of spillage of residual disease on radiological imaging. 4. obstructive jaundice due to involvement of biliary tree by tumour. 5. vascular involvement such as common hepatic artery, mpv right hepatic artery or right portal vein. 6. any distant metastasis or isolated port site metastasis 7. involvement of non-regional ln (e.g . celiac ln, sma lymph node, inter-aortocaval or left para-ortic ln). 8. poor performance status ecog 3 or more. 9. pregnancy. 10. inability or unwillingness to follow study protocol

Keywords: gallbladder, locally advanced, neoadjuvant
correlation between cycle threshold (ct) values in covid-19, health status and laboratory biomarkers in the population of medellin- colombia evaluated in a specialized laboratory.

Conditions: Covid19

Summary: this study will evaluate the correlation between the symptomaticity, ct value, laboratory biomarkers associated to covid-19 and the disease progression in hospitalized patients and outpatients with sars-cov2 infection diagnosed by rt-pcr assay for nasopharyngeal swab specimens in a specialized laboratory at medellin,colombia.

after being informed about the study, all patients giving written informed consent will undergo a serial of test related to covid-19. rh and blood type will be obtained using the colombian id card or official document. all symptomatic and asymptomatic covid19-positive patients will be evaluated for a period of 4 weeks at three different times of the study. in a single time, the mitochondrial dna will be measured, and the variability in the ct value, hemogram, cytokine levels, ratio of cd4 + / cd8 + lymphocytes, levels of dehydrogenase lactate, ferritin and d-dimer, antibodies igg and igm, will be measured on day 5, day 14 and day 28. in addition, spike s protein sequencing and growing the virus in cell culture that meet specific criteria will be performed. a physician will do clinical follow up through the period of the study for each patient.

Eligibility criteria:
inclusion criteria: * people under 18 years old. * covid-19 diagnosis in the last seven days. * specimen analyzed at lime laboratory * description of symptoms related to covid-19 exclusion criteria: * immunocompromised patients * immunosuppressive treatments, chemotherapy or antiretroviral therapy * outpatient anticoagulation therapy * prior immunization for any vaccine in the last 3 months

Keywords: laboratory biomarkers health condition ct value covid-19 mitochondrial dna
pct of pharmacopuncture therapy for chronic low back pain : a pilot study

Conditions: Chronic Low-back Pain

Summary: this is pilot study for a 2-arm parallel pragmatic randomized controlled trial that will compare pharmacopuncture therapy and physical therapy for chronic low back pain.

this is a pragmatic rct, so the physicians will choose the type and volume of pharmacopuncture and the type and time of physical therapy according to participants' conditions, respectively.

Eligibility criteria:
inclusion criteria: 1. low back pain for more than 6 months 2. visual analogue scale (vas) of low back pain is more than 5 3. 19-70 years old 4. participants who agreed and wrote informed consents exclusion criteria: 1. migration of cancer reaching to spine, fracture of spine 2. progressive neurologic deficits or severe neurologic deficits 3. cancer, fibromyalgia, ra, or goat 4. stroke, mi, kidney disease, dimentia, diabetic neuropathy, or epilepsy 5. participants taking steroid, immunosuppressant, or psychotropic medication 6. hemorrhagic disease, severe diabetes or taking anticoagulant drug 7. participants who took nsaids or pharmacopuncture within 1 week 8. pregnant or lactating women 9. participants who had undergone cervical surgery within 3 months 10. participants who had participated in other clinical trial within 1 month, or have plan for participation in other trial during follow up period of this trial 11. participants who can not write informed consent 12. participants who is difficult to participate in the trial according to investigator's decision
human blood specimen collection to evaluate immune cell function

Conditions: Colorectal Cancer; Surgery; Perioperative Care

Summary: natural killer (nk) cells are leukocytes of the innate immune system and play a central role in the control of cancer metastases. nk cells and other innate immune cells often do not function well in patients with cancer and are also profoundly suppressed after cancer surgery. dr. auer's lab and others have shown that nk cells are critically important in the clearance of tumor metastases and that their impairment can be recovered with immune therapy augmenting the innate immune system. several studies suggest that cancer patients have depressed nk cell cytotoxicity as compared to healthy controls but that following resection of the cancer, nk cell cytotoxicity returns to normal levels. in this observational study, the investigators will measure nk cell cytotoxicity by the gold standard method (51cr, a chromium51 release assay) and by a new interferon-ɣ (ifn-ɣ) based assay (nk-vue™) in healthy humans and colorectal cancer (crc) surgery patients seen a the ottawa hospital. the results of this study will determine if the nk-vue™ is able to discriminate between healthy human volunteers and newly diagnosed cancer patients and is sufficiently sensitive to detect transient nk cell suppression immediately following surgery.

rationale: the purpose of this program is to obtain consent for and to outline the process for collection of fresh blood sample from healthy humans and colorectal cancer patients before and after surgical resection. procurement of fresh human blood is required for the following: * to compare nk cell function, measured by two different assays, in healthy humans and newly diagnosed colorectal cancer patients at the ottawa hospital. * to compare nk cell function, measure by two different assays in colorectal surgery patients preoperatively and at various time points postoperatively.

Eligibility criteria:
inclusion criteria: * subjects who have had a recent diagnosis of cancer (any stage) and will be undergoing surgery (cancer group) * subjects who are being seen by their physician for other reasons, or healthy volunteers (control group) * subjects who provide informed consent to participate in the trial * subjects \>40 years of age exclusion criteria:

Keywords: immune suppression natural killer cell mediated immunity natural killer cell cytokine production perioperative/postoperative complications
feasibility study of a coping intervention for recurrent miscarriage

Conditions: Miscarriage

Summary: some women experience the pain of miscarriage on numerous occasions. studies show that these women experience feelings of anxiety and distress during the early stages of a new pregnancy as they worry another miscarriage will occur. this study will investigate whether a coping strategy, developed for a similar group of women, would be acceptable and useful to women suffering recurrent miscarriage, and reduce the anxiety and worry they experience. a secondary aim of the study is to develop a deeper understanding of the experiences and feelings of women in the early stages of a new pregnancy, following multiple miscarriages.


Eligibility criteria:
inclusion criteria: * women with three or more miscarriages * women aged \>18 years * willing and able to give written consent exclusion criteria: * women will be excluded from this study if they do not speak english well enough to understand and complete study materials. this criterion is in place because the study materials (including prci) are not currently available in translation.

Keywords: miscarriage
efficacy of a novel fluoride varnish in preventing wsl during/after treatment with fixed orthodontic appliances

Conditions: Orthodontic Appliance Complication

Summary: the aim of the present study is to evaluate the efficacy of a novel fluoride varnish (nfv) in preventing white spot lesion development in adolescents during and after treatment with fixed orthodontic appliances.

the study will employ a double-blind, randomized placebo-controlled design with two parallel groups. the intervention will start at onset of the fixed appliances and will be finalized one year after debonding. the primary outcome will be incidence of white spot lesions on the labial surfaces of the maxillary incisors, canines and premolars, as assessed from high-resolution digital photos. the secondary outcome is the prevalence of wsls at debonding. during the course of the orthodontic treatment, the patients are regularly checked every 6th week. at the end of each such occasion, the clinical staff will apply either the test or the placebo varnish with a small brush in a thin layer around the base of the braces on the maxillary teeth. the pre- and post-treatment photos are projected on a screen (hewlett packard probook 6650b, palo alto ca, usa) in a dark room and the incidence and severity of enamel demineralization will be registered independently by two experienced and calibrated orthodontists according to the index of gorelick et al. (1982).

Eligibility criteria:
inclusion criteria: * the inclusion criterion is a scheduled treatment with fixed maxillary appliances according a standard straight-wire concept (mclaughlin et al., 2001) during a period of at least 12 months exclusion criteria: * in the event of long-term prescriptions of general antibiotics during the course of the study, this should be recorded separately

Keywords: orthodontics fixed appliance white spot lesions fluoride varnish
efficacy and safety of finerenone in patients with primary aldosteronism

Conditions: Primary Aldosteronism

Summary: to study the efficacy and safety of finerenone in patients with primary aldosteronism

this is a prospective and randomized study involving patients with primary aldosteronism(pa). all paticipants will be randomized into finerenone group(intervention group) and spironolactone group(control group) and to compare the antihypertensive effect in patients with pa. if the self-measured blood pressure of patients at home continues to be greater than 140/90 mmhg at 2-4 weeks, spironolactone or finerenone should be increased to 40mg qd, and electrolytes should be reviewed at 2 weeks after dosed.

Eligibility criteria:
inclusion criteria: patients who meet the following criterion can be included in this study. 1. patients know the whole process of the trial and voluntarily accepted randomization, intervention and follow-up. 2. patients voluntarily participated in the study and signed an informed consent, willing to complete all follow-up visits as required. 3. aged between 18-70, male or female, with legal capacity. 4. egfr≥60(ml/min/1.73 m2) 5. patients with pa and substandard blood pressure (≥140/90mmhg) who didn't take any antihypertensive drugs or who had been using antihypertensive drugs other than mra steadily for 2 weeks or more exclusion criteria: patients with one of the following conditions will be excluded in this study: 1. to assess patients with poor compliance who had difficulty fully participating in the study, or who refused to sign written informed consent for the study 2. patients with heart failure (new york heart association (nyha) class iii or iv), liver transaminase levels were more than 2 times higher than the upper limit of normal, estimated glomerulus filtration rate\<30ml/min/m2 3. patients with serum potassium \> 5.0mmol/l without potassium supplementation 4. patients with stroke or acute coronary syndrome within 3 months 5. pregnant or lactating women 6. patients currently receiving sex hormone or glucocorticoid therapy 7. patients with a history of uncontrolled malignant tumor 8. patients who took mra within 2 weeks

Keywords: finerenone spironolactone
a brain centered neuroengineering approach for motor recovery after stroke: combined rtms and bci training

Conditions: Hemiparesis; Stroke

Summary: the purpose of this study is to determine whether the combination of low frequency repetitive transcranial magnetic stimulation (rtms) and motor-imagery-based brain computer interface (bci) training is effective for enhancing motor recovery after stroke. the pi's hypothesis is that, in comparison with traditional physical therapy alone, subjects receiving supplementary rtms and bci training will show greater functional improvements in hand motor ability over time as well as recovery of normal motor connectivity patterns.

the goal of the present study is to develop and evaluate a brain based approach to improve motor recovery after stroke, by combining rtms and bci training. treatments will consist of low frequency rtms applied to the contralesional hemisphere, followed by bci training to encourage activity within the lesioned hemisphere. the primary objective of this study is to test the main hypothesis above in a stroke patient population. subjects will also undergo a period of bci only treatments after completion of the combined rtms and bci portion.

Eligibility criteria:
inclusion criteria: * 18-70 years of age * cortical or subcortical stroke with isolated unilateral motor paresis * at least 3 months but no greater than 12 months post stroke and in stable conditions as judged by patient's physician * impaired hand function compared to nonparetic side but at least 10 degrees of active finger extension * able to ambulate at least 50 feet with minimal stand-by assistance * upper extremity fugl meyer (fugl-meyer et al., 1975) score of greater than or equal to 20 out of 66 * beck depression inventory (beck et al., 1961) less than or equal to 19 out of 63 * mini-mental state examination score (folstein et al., 1975) greater than or equal to 24 out of 30 * must have an ipsilesional motor-evoked potential (mep) in response to tms * must be stable outpatients currently undergoing rehabilitation consistent with the current standards of care * must be able to communicate clearly in english * must be able to provide consent in writing. exclusion criteria: * personal history of epilepsy or seizures within the past 2 years * previous surgical procedure to the spinal cord * any mri incompatible devices * pregnancy * claustrophobia * breathing disorder * hearing problems or ringing in the ears * bilateral motor paresis or paralysis or those patients that would require significant medical monitoring or management beyond that of a stable outpatient * cognitive deficits, other non-motor neurological impairment, bilateral motor paresis or paralysis or those patients that would require significant medical monitoring or management beyond that of a stable outpatient

Keywords: hemiparesis stroke rehabilitation transcranial magnetic stimulation, repetitive electroencephalography functional neuroimaging brain-computer interface
evaluation of richmond agitation sedation scale according to alveolar concentration of sevoflurane during a sedation with sevoflurane in icu patients

Conditions: Requiring Sedation by Sevoflurane in ICU; Adult Patients; Patients Covered by French Health Care System; Patients Who Have Given Their Consent

Summary: describe the richmond agitation sedation scale (rass) values corresponding to the values of minimum alveolar concentration of sevoflurane during sedation of patients in icu

prospective clinical study in icu with sedated ventilated patients with sevoflurane using the mirus® system. pharmacological study of the concentration-effect relationship by administration at increasing and decreasing concentrations.

Eligibility criteria:
inclusion criteria: * requiring sedation by sevoflurane in icu * adult patients * patients covered by french health care system * patients who have given their consent or his family exclusion criteria: * pregnant or lactating women * sevoflurane anaphylaxia * known or suspected risk of malignant hyperthermia * refusal protocol * brain-damaged patients * hemodynamic conditions not compatible with the use of sevoflurane * ards patients * minor patients

Keywords: sevoflurane rass score sedation minimal alveolar concentration (mac)