Kornimate/medical-research-clean huggingface dataset:
retrospective study of surgical induced abortions between 14 and 16 weeks of amenorrhea at croix rousse university hospital in lyon

Conditions: Induced Abortion; Instrumental Induced Abortion Between 14 and 16 Weeks of Amenorrhea

Summary: in france, induced abortions can be carried out by two different methods: the medicinal one, which involves taking medications to expel the pregnancy (mifepristone and then misoprostol), and the instrumental one, which involves aspiration in the operating room. according to the high authority of health, before 9 weeks of amenorrhea, both methods are possible if there is no contraindication to one of them. after 9 weeks of amenorrhea, only the instrumental method is authorized. until march 2022, the maximal deadline to abort was 14 weeks of amenorrhea. on march 2nd 2022, a change in the law extended this time limit from 14 to 16 weeks of amenorrhea. only one study was carried out following this change in france to assess the complication rate of late abortions (between 14 and 16 weeks of amenorrhea (aw)). this study was carried out at trousseau hospital in paris, with a total of 46 patients. the results of this study were reassuring, with bleeding \> 500 ml for only one patient (2.2%, 95% ci \[0.0-6.4\]) and no complications such as perforation, postoperative infection or revision surgery, or need for transfusion. however, this paper is the only french study which evaluated the operative risks of late abortion since the change in the law, and its power is small. there is a need to assess the operative risks of late abortion on a larger cohort. that's why the investigators had the idea to conduct a study looking at all instrumental abortions performed in croix rousse hospital in lyon between march 2022 and march 2023, representing around 700 procedures. the aim of the study is to compare the complication rates of instrumental abortions between 14 and 16 weeks of amenorrhea versus those carried out before 14 weeks.


Eligibility criteria:
eligibility criteria \* * inclusion criteria \* : * surgical induced abortion * at croix rousse hospital, lyon * between march 2022 and march 2023 * exclusion criteria \* : * minor patients

Keywords: interruption of pregnancy induced abortion instrumental technique women complications
screening an orthopedic population for mildly-affected individuals with morquio syndrome a and maroteaux-lamy syndrome

Conditions: Morquio Syndrome A; Maroteaux Lamy Syndrome; MPS IVA; MPS VI

Summary: the purpose of this study is to identify patients with morquio syndrome type a (mps iva) and maroteaux-lamy syndrome (mps vi) who may have been missed or misdiagnosed due to atypical clinical features, a milder course, and/or negative urine screening. we will recruit participants who have certain hip and/or joint problems that could potentially be caused by one of these two genetic conditions through a chart review process conducted at shriners hospital for children in greenville, sc. diagnostic testing will be performed for each participant to determine if he or she is affected by one of these two conditions. results will be disclosed to all participants and their legal guardians, and appropriate follow up will be recommended for those who are found to have abnormal results.


Eligibility criteria:
inclusion criteria: * eligible participants must currently receive care in the shriners hospitals for children system, and therefore, will be under 19 years of age. * eligible participants must have one of the following diagnoses: bilateral legg-calve-perthes disease, bilateral hip dysplasia, multiple joint pain, unidentified skeletal dysplasia * eligible participants (or legal guardian) must be able and willing to sign informed consent/assent in english or spanish. exclusion criteria: * participants with one or more or the above inclusion diagnoses who have a specific etiologic diagnosis will not be eligible to participate in this study. * if we are unable to obtain the necessary specimens, the participant will be removed from the study.
risk stratification in patients with preserved ejection fraction

Conditions: Myocardial Infarction

Summary: the purpose of the study is to assess the prevalence and the prognostic value of non-invasive indexes and programmed ventricular stimulation for sudden cardiac death in post-myocardial infarction (mi) patients with left ventricular ejection fraction (lvef)\>40%.

1000 asymptomatic post-mi patients\>40%, at least 40 days post-mi, revascularized or without needing further revascularization (in any case without any evidence of ischemia) will be enrolled. the patients will be divided into two categories: 1. asymptomatic patients with revascularized st-elevation mi (stemi) (remaining stenoses in non culprit vessels \ 40% will be re-assessed) 2. asymptomatic patients late (at any time after 40 days) after mi (initially stemi-nstemi at discharge q-non q) with lvef\>40% right after a negative stress test or right after a negative for stenoses control coronary catheterization all patients will undergo non-invasive evaluation (ecg, holter monitoring and 45-min high resolution recording). in case they fulfill at least one out of seven pre-specified criteria they will undergo programmed ventricular stimulation and implantable cardioverter-defibrillator (icd) implantation (if inducible) all patients will be followed-up for 3 years for sudden cardiac death and its surrogate (appropriate icd activation)

Eligibility criteria:
inclusion criteria: * asymptomatic patients with revascularized stemi (remaining stenoses in non culprit vessels \ 40% will be re-assessed) * asymptomatic patients late after mi (initially stemi-nstemi at discharge q-non q) with lvef\>40% right after a negative stress test or right after a negative for stenoses control coronary catheterization exclusion criteria: * episodes of sustained vt or aborted sudden cardiac death (scd) 48 hours after the acute mi phase. * episodes of syncope within the last 6 months * cancer, liver failure (cirrhosis), end-stage renal disease * use of anti-arrhythmic drugs other than b-blockers

Keywords: myocardial infarction risk stratification sudden cardiac death preserved ejection fraction programmed ventricular stimulation
mr-guided focused ultrasound treatment of prostate cancer: focal therapy for locally non-advanced disease

Conditions: Prostate Cancer

Summary: since prostate specific antigen (psa) was introduced as a clinical screening tool for prostate cancer, more men are diagnosed with small foci of cancers instead of the advanced disease. the present choice of treatment for men with localized prostate cancer lies between active surveillance and radical therapy. thus, the option of treating only the cancer within the prostate gland and sparing the non-cancerous tissue is quite appealing, yet very controversial. at present there are no consistent scientific data on focal therapy and its major effectiveness. focal therapy for prostate cancer is defined as therapy that selectively ablates known disease while preserving existing functions, with the overall aim of minimizing lifetime morbidity without compromising life expectancy. the aim of the investigators study is to test if magnetic resonance guided focused ultrasound ablation can determine non-invasive necrosis of focal, locally non-advanced prostate cancer. the study i designed as phase 1, treatment \& resection protocol. with this project the investigators further aim to evaluate the safety and identify side effects of magnetic resonance guided focused ultrasound in treating focal prostate cancer. this design will also expand knowledge of the effect of magnetic resonance guided focused ultrasound onto peri-prostatic environment and to determine if surgery can safely be adopted after this non-invasive treatment.


Eligibility criteria:
inclusion criteria: * patient of age between 40 to 85 * patient with organ-confined pca (ct1c and ct2a, n0, m0), diagnosed with trus biopsy (min:12 cores) * patient with psa ≤ 10 ng/ml * gleason score 6 (3+3) or max 7 (3+4) * up to two (2) mr identifiable lesions * no definite evidence of extracapsular extension exclusion criteria: * patient under medications that can affect psa for the last 3 months prior to mrgfus treatment (androgen deprivation treatment; alpha reductase inhibitors) * any rectal pathology, anomaly or previous treatment * identified calcification of 2 mm or more in largest diameter neighboring the rectal wall * bladder cancer * seminal vesicle/lymph node * prostate with multiple cystic lesions

Keywords: prostate cancer high intensity focused ultrasound magnetic resonance guided focused ultrasound non-invasive therapy focal disease
austrian hypertrophic cardiomyopathy registry

Conditions: Hypertrophic Cardiomyopathy

Summary: the austrian hypertrophic cardiomyopathy (hcm) registry is a prospective, multicenter registry enrolling patients at multiple outpatient clinics across austria including academic and non-academic centers. patients will undergo a structured examination process including assessment for symptoms of hcm, past medical history, concomitant medication, family history and the presence of hcm-specific red flags. furthermore, clinical data derived from electrocardiogram, echocardiography, laboratory analysis, and genetic testing will be collected focusing on a lean variable dictionary and, in addition, specific hypothesis-driven research parameters. all data are entered into an electronic case report form (ecrf) (phoenix clinical trial management system). in order to perform multicenter analyses, data can be extracted from the ecrf after approval by the steering committee.

the austrian hypertrophic cardiomyopathy (hcm) registry is a prospective, multicenter registry enrolling patients at multiple outpatient clinics across austria including academic and non-academic centers. patients will undergo a structured examination process including assessment for symptoms of hcm, past medical history, concomitant medication, family history and the presence of hcm-specific red flags. furthermore, clinical data derived from electrocardiogram, echocardiography, laboratory analysis, and genetic testing will be collected focusing on a lean variable dictionary and, in addition, specific hypothesis-driven research parameters. all data are entered into an electronic case report form (ecrf) (phoenix clinical trial management system). every site will nominate one representative for the steering committee which will serve as the regulatory authority with the compentence to approve research and funding proposals. the austrian multicenter hcm registry aims to facilitate a wide range of innovative cross-sectional and longitudinal epidemiological analyses unravelling gaps in evidence in hcm. the standardized clinical assessment might harmonize standards of clinical care in hcm patients in austria.

Eligibility criteria:
inclusion criteria: * patients admitted to the hcm outpatient clinic of participating centers of the hcm registry * interventricular septal thickness ≥ 13 mm and cardiomyopathy-specific red flags or interventricular septal thickness ≥ 15 mm not explainable by loading conditions or interventricular septal thickness ≥ 17 mm * willingness and ability to provide signed informed consent form (icf) prior to participation in any study-related procedures exclusion criteria: * age \< 18 years * known cardiac amyloidosis

Keywords: hypertrophic cardiomyopathy left ventricular hypertrophy hypertrophic phenotype
feasibility of kanasina gulabi, a pilot peer support intervention for young adults with type 2 diabetes in mysore district, south india

Conditions: Type 2 Diabetes; Quality of Life; Depression; Stigma, Social; Behavior, Health

Summary: the purpose of this study is to evaluate a pilot peer support intervention, entitled "kanasina gulabi" (translation "my dream rose" in kannada), designed to improve quality of life and diabetes management among young adults living with type 2 diabetes. the intervention, delivered by non-specialist providers - trained young adult peer navigators who are also managing type 2 diabetes - is expected to improve physical and mental health outcomes among participants. the sample includes young adults aged 18-40 with a diagnosis of type 2 diabetes in mysore district, south india. participants were quasi-randomly allocated to the intervention or control group. with the support of their peer navigators, intervention participants will develop action plans to improve their physical and mental health outcomes. this study plans to assess the feasibility, acceptability, and preliminary effectiveness of the intervention.


Eligibility criteria:
inclusion criteria: * aged 18 - 40 years old * self-reported to have type 2 diabetes * living in mysore district * able to speak english or kannada * and able to access a cellular phone during the study period exclusion criteria: * pregnant * living with a serious medical or psychological disorder that would impede study procedure

Keywords: young adult india
multiple micronutrient supplementation for maternal anemia prevention in tanzania

Conditions: Pregnancy Related

Summary: this is an individually randomized controlled trial to assess the effect of multiple micronutrient supplements (mms) containing 60 and 45 mg iron as compared to mms containing 30 mg of iron (standard unimmap formulation) on maternal moderate or severe anemia. this study will help inform countries like tanzania that currently use ifa containing 60 mg of iron regarding the dose of iron to use in mms.


Eligibility criteria:
inclusion criteria: * attending first anc visit at study clinics * pregnant women \< 20 weeks gestation by last menstrual period (lmp) * aged ≥ 18 years old * intending to stay in dar es salaam until 6 weeks post delivery * provides informed consent exclusion criteria: * severe anemia (defined as hemoglobin \< 8.5 g/dl per tanzania standard of care) * sickle cell disease (ss and sc) and hemoglobin c disease (cc) as tested by hemotypesc * concurrently enrolled in another nutritional clinical trial * pregnant women with disability or condition which would impair their ability to provide informed consent and complete study procedures.

Keywords: pregnancy multiple micronutrient supplementation iron anemia tanzania
quantifying activity using wireless wearable technology

Conditions: Activity, Motor; Sleep; Delirium

Summary: wireless wearable devices (wwd) have been shown to be an effective means to measure patient activity and sleep-wake cycles in the icu. however, no current studies involving wwd have demonstrated the ability of these devices to measure adverse outcomes, including delirium in critically ill patients. this study is unique because the investigators will implement monitoring with the wwd prior to extubation in the icu to correctly measure first mobilization, as well as capture quality of sleep and episodes of delirium for the first five postoperative days.

in this single-center non-randomized prospective cohort study, cardiac surgical patients undergoing cardiac surgery with cardiopulmonary bypass will be enrolled consecutively with written informed consent from the time this protocol is approved by the irb until 100 subjects are enrolled (expected duration of subject enrollment is 12 months). upon arrival into the icu, cardiac surgery subjects will have a fitbit charge 2 device placed on their wrist and will wear the device until the fifth post-operative day. this device will wirelessly transmit data regarding activity and sleep quality to a smartphone application for the duration of wear. no identifiable patient information will be entered into the smartphone application or transmitted to any external entity.

Eligibility criteria:
inclusion criteria: * inclusion criteria: adult (age \> 18) patients undergoing scheduled, elective cardiac surgery with cardiopulmonary bypass exclusion criteria: * those who do not meet the inclusion criteria, pregnant women, prisoners, those with skin or systemic infections, those who are paraplegic or quadriplegic and those with allergies to the polyurethane material comprising the fitbit strap.
the effects of curcuminoids on aberrant crypt foci in the human colon

Conditions: Aberrant Crypt Foci

Summary: the purpose of this study is to determine the effectiveness of curcumin in reducing the number of aberrant crypt foci (acf) in the colon.

laboratory studies have indicated that this agent, which is derived from plants and found in foods we eat, has anti-inflammatory properties and prevents colon cancer in animal studies. acfs are small abnormalities in the lining of the colon that with time may grow into colorectal adenomas (also called polyps, growths or small masses of tissue on the lining of the colon or rectum which have the potential to become cancerous) which can then grow into adenocarcinomas (cancer) in the colon or rectum.

Eligibility criteria:
inclusion criteria: * subjects must be eligible for colorectal cancer (crc) screening/surveillance by current criteria. * subjects must have at least 5 acf on eligibility chromosigmoidoscopy examination. exclusion criteria: subjects must not have: * alcohol consumption of greater than 2 glasses of wine or beer per day or illicit recreational drug use * platelet or coagulation abnormalities, or personal history of a bleeding disorder, including individuals taking warfarin. * high risk for developing endocarditis (history of endocarditis or rheumatic fever, cardiac valve prostheses, or mitral valve prolapse that requires antibiotic prophylaxis). * uncontrolled hypertension, diabetes, or chronic congestive heart failure. * renal insufficiency defined as a serum creatinine \> 2.5 mg/dl * history of colorectal surgery with removal of the distal 60 cm of colon or rectum. * history of other gastrointestinal mucosal epithelial diseases (such as barrett's esophagus, chronic or recurrent peptic ulcer disease, celiac sprue or other disorders of nutrient absorption).

Keywords: aberrant crypt foci
a study of xeloda (capecitabine) plus radiotherapy in participants with locally advanced rectal cancer

Conditions: Colorectal Cancer

Summary: this single arm study will assess the efficacy and safety of treatment with xeloda plus standard pelvic radiotherapy in participants with locally advanced rectal cancer. eligible participants will receive xeloda 825mg/m\^2 orally twice daily plus standard radiotherapy for 5 weeks, followed by surgery within 6 weeks after completion of treatment. the anticipated time on study treatment is \< 3 months, and the target sample size is \< 100 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, 18-80 years of age; * rectal cancer; * planned surgery, and likely to benefit from pre-operative combined chemo-radiotherapy; * eastern cooperative oncology group (ecog) performance status 0-2 exclusion criteria: * previous radiotherapy or chemotherapy for colorectal cancer; * clinically significant cardiovascular disease; * significant gastric or small intestine disease; * serious uncontrolled active infection
comparative analysis of two therapeutic strategies in patients with spondyloarthritis treated with anti-tnf biologics

Conditions: Spondyloarthritis

Summary: the objective of the study is to evaluate two therapeutic strategies: "early switch" or "therapeutic intensification" in patients with spondyloarthritis in case of secondary treatment failure suspicion to a first monoclonal antibodies anti-tnf definite by increase of asdas and positivity to adab. patients and methods: multicentric randomized prospective study. duration of inclusion 30 months. duration of follow-up 24 months. 104 patients with spondyloarthritis treated with infliximab or adalimumab will be included if their adab dosage is positive, and they will be randomized (1:1) in two groups : "early switch" where treatment will be change to another anti-tnf, or "therapeutic intensification" where interval between two injections will be shortened. patients will be evaluated clinically (asdas) and biologically (adab) at 12 weeks then at 24 weeks. principal outcome will be the variation of asdas between baseline and end of the study. number of patients to be included has been determined statistically from a preliminary study (power \>98% for asdas variation of 20% on week 24). expected results: on week 24, we expect a better response and a greater proportion of patients in remission in the "early switch" arm compare to the "therapeutic intensification" arm.


Eligibility criteria:
inclusion criteria: * spondyloarthritis positive for the asas criteria, treated with a first biologic : infliximab ( 5mg/kg intravenously every 8 weeks) or adalimumab (40mg subcutaneously every 2 weeks) * active spondyloarthritis definite by asdas-crp \> 2.1 at two successive evaluations while patient was previously responder (asdas\<2.1 at least once in the 6th months after beginning of treatment) * positivity to anti-drug antibodies (adab) * consent of the patient * no contra-indication to another anti-tnf biologic * affiliation to health insurance * woman of childbearing age must use an appropriate mean of contraception exclusion criteria: * pregnant or breastfeeding woman * contra-indication to anti-tnf biologic * patient with known hypersensitivity to any of the excipients * severe and uncontrolled opportunistic infection , includins septicemia, tuberculosis, abcess and opportunistic infection * evolutive infection, including chronic or localised infection * patient with moderate to severe heart failure (nyha class iii/iv)

Keywords: spondyloarthritis monoclonal antibodies anti-tnf secondary treatment failure
a study of wvt078 in patients with multiple myeloma (mm)

Conditions: Multiple Myeloma (MM)

Summary: the design of a phase i, open-label, dose finding study was chosen in order to establish a safe and tolerated dose of single agent wvt078 alone and in combination with whg626 in patients relapses and/or refractory multiple myeloma (mm)

this first-in-human trial with wvt078 is a dose escalation study whose primary purpose is to characterize the safety, tolerability, and determine recommended dose regimen(s) of wvt078 alone and in combination with whg626 in subjects with mm who have received two or more standard of care lines of therapy including an imid, a proteasome inhibitor, and an anti-cd38 agent (if available) and are relapsed and/or refractory to or intolerant of each regimen. in addition, this study will assess preliminary anti-mm response of and characterize the pharmacokinetics and immunogenicity of wvt078 alone and in combination with whg626. the results of this study will inform the future development of wvt078 alone and in combination with whg626 as a treatment for relapsed and/or refractory mm.

Eligibility criteria:
inclusion criteria: * subjects who are relapsed and/or refractory to two or more regimens including an imid, proteasome inhibitor, and an anti-cd38 agent (if available) exclusion criteria: * use of systemic chronic steroid therapy (\>or= 10mg/day prednisone or equivalent) or any immunosuppressive therapy within 7 days of first dose of study treatment * malignant disease other than being treated on this study * active known or suspected autoimmune disease * impaired cardiac function or clinically significant cardiac disease * treatment with cytotoxic or small molecule antineoplastics or any experimental therapy within 14 days or 5 half-lives whichever is shorter * active central nervous system involvement by malignancy or presence of symptomatic cns metasteses

Keywords: multiple myeloma, phase 1