Kornimate/medical-research-clean huggingface dataset:
study of olmesartan medoxomil (cs-866) in patients with chronic glomerulonephritis or diabetic nephropathy

Conditions: Chronic Glomerulonephritis; Diabetic Nephropathy

Summary: the treatment period was 16 weeks, the initial dose, 5 mg, was unforcedly titrated to 10 mg, 20 mg and 40 mg after confirming tolerance at weeks 4, 8 and 12. the primary endpoint for efficacy was the change in the urinary protein/creatinine ratio from baseline to the end of treatment. the secondary endpoint was creatinine clearance (ccr).


Eligibility criteria:
inclusion criteria: * urinary protein/creatinine ratio in the 0.50 g/g to 3.50 g/g creatinine range * normal sitting blood pressure values: systolic blood pressure of 100 mmhg or above but below 140 mmhg; diastolic blood pressure of 50 mmhg or above but less than 90 mmhg exclusion criteria: * treatment with corticosteroids or immunosuppressants * treatment with antihypertensives (other than arbs and ace inhibitors) * serum potassium level of 5.5 meq/l or above * serum creatinine level of 2.0 mg/dl or above

Keywords: chronic glomerulonephritis diabetic nephropathy angiotensin ii receptor blocker urinary protein
fenofibrate in patients with primary biliary cholangitis (pbc)

Conditions: Primary Biliary Cholangitis

Summary: an open label long-term study to evaluate the safety and effectiveness of fenofibrate in subjects with primary biliary cholangitis (pbc)


Eligibility criteria:
inclusion criteria: * must have given written informed consent (signed and dated) * participated in the pbc study with fenofibrate (nct02823353) * females of reproductive potential must use at least one barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. male subjects who are sexually active with female partners of reproductive potential must use barrier contraception and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose exclusion criteria: * treatment-related adverse event (ae) leading to fenofibrate discontinuation * a medical condition, other than pbc, that in the investigator's opinion would preclude full participation in the study or confound its results (e.g., cancer) * known history of other liver diseases * for females, pregnancy or breast-feeding * long-term use of immunosuppressive agents * any other condition(s) that would compromise the safety of the subject or compromise the quality of the clinical study, as judged by the investigator
the insulin resistance in recurrent miscarriage in recurrent abortion

Conditions: Recurrent Abortion

Summary: the insulin resistance in recurrent abortion

the role of insulin resistance in recurrent abortion

Eligibility criteria:
inclusion criteria: 1. women in the child bearing period between 23-40 years. 2. all patients are pregnant. 3. the gestational age of both groups 6-13 weeks exclusion criteria: 1. patients with gestational diabetes and gestational impaired glucose tolerance. 2. the patients who took medication that could affect glucose metabolism at the time of the study 3. patients with other causes of recurrent abortion as(thyroid dysfunction, uterine anomalies chromosomal abnormalities, antiphspholipid antibody syndrome, uterine anomalies and torch syndrome). 4. patients with pcos. 5. obese patients(bmi\>30)
evaluation of customized v plate versus conventional miniplates of mandibular angle fracture

Conditions: Mandibular Fractures

Summary: the aim of the study to evaluate the effect of customized v pattern plate fixation versus a conventional superior-inferior mini plates fixation of mandibular angle fracture on mouth opening and radio graphical parameters.

the mandibular angle is one of the most common sites for fractures, accounting for 23-42% of all cases of mandibular fractures. moreover, mandibular angle fractures have the highest postoperative complications among all mandibular fractures, and the loosening of screws and fracturing of plates are main reasons for the complications.the most widely used treatment modality for mandibular angle fracture is the use of one miniplate fixation ,the other one uses two mini-plates, with a upper mini-plate fixed at the same place of previous treatment which corresponds to the tension band of the mandible, and the lower mini-plate fixed at the inferior border of the mandible which corresponds to the compression band of the mandible, however, based on recent experimental and clinical studies, the stability provided by the miniplate fixation of mandibular angle fractures has become a point of contention among surgeons .in order to decrease the need for plate removal, reduce the operative time and improve the stability of the fixation system, a customized v pattern plate design is an appropriate plate structure for fractured mandible using the minimum output values for stress of plate and displacement of bony segments to seek maximum reduction volume on an original plate .patient satisfaction include: clinical parameters such are occlusion, pain, facial swelling, maximal mouth opening, sensory function, and surgical wound ,these should be evaluated postoperatively ,radio graphical evaluation is also an important parameter to assess adequate reduction of the fractured segments .

Eligibility criteria:
inclusion criteria: * patients with at least a unilateral unfavorable angle fracture indicated for open reduction internal fixation alone or in combination with fracture elsewhere in the mandible or midrace. * patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome exclusion criteria: * patients with systemic disease (may affect normal healing). * patients with old and/or malunited fractures (affect accuracy of reduction of the fractured segments). * patients whom cannot tolerate follow up intervals (affect accuracy of study results).

Keywords: angle fracture superior-inferior plate fixation custom made plate fixation postoperative complications
oral microbiota and oral status of adult patients with autism spectrum disorders (micaa: microbiota autism adults)

Conditions: Autism Spectrum Disorder

Summary: the goals of this pilot study are to assess the presence of harmful germs for gums and to assess oral health in adults with autism spectrum disorder.

participants or their tutors will fulfill a form with general health information and daily habits. investigators will : * collect saliva, gum fluid and/ or dental plaque to characterise germs * assess gum health and oral hygiene * register decays, filled and missing teeth.

Eligibility criteria:
inclusion criteria: * a person (or legal representative) who has received full information about the organisation of the research and accept to participate and the use of his or her data. * adult with autism spectrum disorder, men or women aged between 18 and 60. * member of a social security scheme or beneficiary of a medical insurance exclusion criteria: * children under 18 with autism spectrum disorder * use of medication or situations that may affect the microbiota (use of antibiotics, probiotics, steroidal or non-steroidal anti-inflammatory drugs in the last 3 months, strict mouth breathing) * smoking * very lingual position of the teeth hindering clinical assessment of the periodontium * patients who have had periodontal treatment for less than 6 months * persons covered by articles l. 1121-5 to l. 1121-7 and l1122-2 of the french public health code: * pregnant women, women in labour or breast-feeding mothers * persons deprived of their liberty by a judicial or administrative decision * persons unable to give their consent * person under psychiatric care by virtue of articles l. 3212-1 and l. 3213-1 of the public health code * minor (not emancipated)

Keywords: autism spectrum disorder oral microbiota oral health
pap adherence after diet/lifestyle intervention in osa patients

Conditions: Obstructive Sleep Apnea

Summary: the aim of this study is to explore the role of diet/lifestyle intervention on positive airway pressure (pap) treatment adherence in patients with obstructive sleep apnea (osa).specifically, we evaluated the effects of a combination of pap and weight-loss mediterranean diet intervention on improving pap adherence, body mass index (βμι), daytime symptoms, mainly sleepiness and arterial blood pressure measurements over the effect of standard care alone.

we designed a parallel, randomized, controlled, clinical trial. eligible participants are adult, overweight and obese men and women, diagnosed with moderate-to-severe osa \[apnea-hypopnea index (ahi)≥15 events/h\] through an attended overnight polysomnography. participants, after written informed consent, were blindly randomized to a standard care group (scg, n=37) and a mediterranean diet group (mdg, n=37). study groups were prescribed pap. the scg received oral healthy lifestyle advice and counseling on physical activity and sleep habits, while the mdg was additionally subjected to a 6-month behavioral intervention aiming at weight loss and increasing adherence to the mediterranean diet. pap adherence (hours of device use), bmi, daytime sleepiness, evaluated by epworth sleepiness scale (ess) and arterial blood pressure measurements were evaluated pre- and post-intervention.

Eligibility criteria:
inclusion criteria: * patients aged \>18 years with newly diagnosed moderate to severe osa \[apnea-hypopnea index (ahi)≥15 events/h\] through an attended overnight polysomnographyaccording to standard criteria * overweight and obese \[bmi\>25 kg/m2\] * eligible for pap treatment with adherence data available in the 6-months after initiation of treatment and * with an above-elementary school education. exclusion criteria: * refusal to participate * patients on pap treatment * current participation in a weight loss program * central sleep apnea syndromes * obesity hypoventilation syndrome * restrictive ventilator syndromes * severe congestive heart failure * a history of life-threatening arrhythmias * severe cardiomyopathy * long-term oxygen therapy * chronic kidney disease * family or personal history of mental illness * drug or alcohol abuse * severe cognitive impairment * concurrent oncological diseases * pregnancy or lactatio * recent hospitalization for acute or chronic respiratory disease * history of narcolepsy or restless leg syndrome

Keywords: obstructive sleep apnea treatment adherence positive airway pressure (pap) treatment diet/lifestyle intervention mediterranean diet
adrenal function in patients with newly diagnosed lung cancer

Conditions: Lung Cancer; Adrenal Insufficiency

Summary: patients with newly diagnosed lung cancer may have hypofunction of the adrenal cortex either from tumour metastasis or other mechanisms. since lung cancer patient may have to undergo stressful investigation and treatments, undetected hypofunction of the adrenal cortex may be hazardous. knowledge of the size of the problem may help determine whether routine check is warranted.


Eligibility criteria:
inclusion criteria: * histologically proven primary lung cancer * newly diagnosed * no specific treatment given * no active infection in the previous week * no general anesthesia in the previous week exclusion criteria: * known adrenal disease * receiving exogenous systemic corticosteroids * concomitant illness known to affect adrenal function. e.g. active tb

Keywords: lung cancer adrenal insufficiency
an observational study of patients with autoimmune disease

Conditions: Autoimmune Diseases

Summary: target-autoimmune is an observational research study to conduct a comprehensive review of outcomes for patients with autoimmune and related diseases. .


Eligibility criteria:
disease cohort inclusion criteria: - adult patients at the time of enrollment with a diagnosis autoimmune disease by select icd-10 codes in the ehr interface exclusion criteria: * death * manual removal (sponsor or site request) * no ehr interface encounter \> 3 years engaged cohort inclusion criteria: * adult patients diagnosed and managed for these conditions invited to participate * ability to provide written informed consent exclusion criteria: * patient expressed desire to withdraw consent to complete pros * failure to complete pros within 24 weeks of initial invitation * greater than 24 months lapse of survey completion after baseline surveys completed * additionally, the criteria detailed for disease cohort apply to the engaged cohort
opening the conversation study

Conditions: Breast Cancer; Gynecologic Cancer

Summary: young adult survivors of breast and gynecologic cancer face a number of challenges, including interrupted life plans. as many as two-thirds of these young survivors experience negative effects of cancer and cancer treatment on their reproductive health, including sexual function and ability to have children. these are among the most distressing aspects of life after cancer for young survivors and their partners, and when left unaddressed, lead to poorer mental health and quality of life. yet, surprisingly, evidence-based programs are not available to help young couples manage this aspect of life after cancer. in this study, we will adapt and evaluate an intervention designed to help young couples cope with and communicate about cancer-related reproductive and sexual health concerns.

the specific aims of the study are: aim 1 (phase i). systematically adapt an empirically supported couple-based skills training intervention to help young breast and gynecologic cancer (bgc) survivors and their partners jointly manage the reproductive and sexual health consequences of cancer. aim 2 (phase ii - quantitative). evaluate the efficacy of the intervention and hypothesized mediators by conducting a randomized trial. we will evaluate the efficacy of the newly adapted intervention, opening the conversation (oc), on survivors' and their partners' reproductive and sexual distress as well as the relationship, sexual, and psychosocial health outcomes. we will determine whether dyadic coping and communication mediate intervention effects on survivors' and partners' reproductive and sexual distress. aim 3 (phase ii - qualitative). evaluate couples' experiences within and across conditions to gain in-depth knowledge of intervention components that influence hypothesized mediators and outcomes.

Eligibility criteria:
inclusion criteria: cancer survivor participants: * cancer diagnosis between ages 18-39 years * current age 18-44 * cancer diagnosis 6 months-5 years prior to enrollment * diagnosed with breast and/or gynecologic cancer * cancer stage 1-4 * ability to participate in a videoconference intervention * has committed partner willing to participate * english speaking * high speed internet access via smart phone, tablet and/or computer partner participants: * age 18 or older * english speaking * ability to participate in a videoconference intervention * high speed internet access via smart phone, tablet and/or computer exclusion criteria: -cancer survivors and partners are excluded if either partner does not meet eligibility criteria. both partners must enroll or the dyad will be excluded.
coronary aspiration catheter clinical trial

Conditions: ST-segment Elevation Myocardial Infarction (STEMI)

Summary: to evaluation of the efficacy and safety of an aspiration catheter in patients undergoing pci for acute st-segment elevation myocardial infarction (stemi).


Eligibility criteria:
inclusion criteria: - general inclusion criteria 1. age 18-80 years old (inclusive); 2. clinical diagnosis of acute st-segment elevation myocardial infarction (stemi) within 24 hours of the onset of the disease (where st-segment elevation is defined as st-segment elevation of ≥1mm or 0.1mv in 2 or more consecutive leads of the 12-lead ecg); 3. voluntary participation and signed written informed consent. imaging inclusion criteria 4. dsa image showed that the target lesion was in situ coronary artery lesion; 5. target vessel timi thrombus load classification ≥ grade 3 and timi flow classification ≤ grade 1; exclusion criteria: - general exclusion criteria 1. previous pci intervention or coronary artery bypass grafting (cabg) in the target vessel; 2. comorbid cardiogenic shock; 3. severe renal failure or ongoing dialysis; 4. severe coagulation abnormalities (e.g., hypercoagulability due to blood disorders); 5. failure of preoperative thrombolysis requiring remedial pci; 6. serious bleeding events requiring transfusion therapy within 30 days prior to surgery; 7. ischemic stroke within 3 months prior to surgery; 8. known allergy to anticoagulant and antiplatelet agents or contrast media; 9. female subjects who are known to be pregnant or lactating; 10. participation or planned participation in other clinical studies of drugs or devices; 11. other conditions that the investigator evaluates to be unsuitable for participation in this trial. imaging exclusion criteria 12. prognostic aspiration catheter needs to pass through the original stent mesh to reach the thrombus aspiration site; 13. severe calcification or tortuosity of the target vessel or extreme angulation that would interfere with the passage of the suction catheter; 14. the presence of an unprotected left main lesion (more than 50% narrowing of the lumen diameter); 15. the presence of severe triple coronary artery lesions requiring revascularization.
using artificial intelligence to optimize delivery of weight loss treatment

Conditions: Obesity; Weight Loss

Summary: project relearn is testing the efficacy and cost-effectiveness of an artificial intelligence system for optimizing weight loss coaching. participants are randomized to a 1-year weekly gold standard behavioral weight loss remote (video) group treatment or the ai-optimized treatment, which is made up of a combination of remote group treatment, short video call and automated message. in the ai-optimized condition, the system monitors outcomes (via wireless scale, mobile phone app, and wristworn tracker) and, each week, assigns each participant the treatments they have responding to the best, within certain time constraints.


Eligibility criteria:
inclusion criteria: * individuals must be of overweight or obese bmi (27-50 kg/m) * individuals must be adults (aged 18-70) * able and willing to engage in the remote program * able to engage in physical activity (defined as walking two city blocks without stopping) * individuals must also provide consent for the research team to contact their personal physician if necessary, to provide clearance or to consult about rapid weight loss * access and willingness to use an apple or android smartphone * satisfactory completion of all enrollment procedures exclusion criteria: * medical condition (e.g., cancer, type i diabetes, psychosis, full-threshold eating disorder) that may pose a risk to the participant during intervention or cause a change in weight * currently pregnant, breastfeeding, or planning to become pregnant in the next 12 months * recently began or changed the dosage of medication that can cause significant change in weight * history of bariatric surgery * weight loss of \> 5% in the previous 3 months

Keywords: obesity weight loss behavioral treatment artificial intelligence
faecal analyses in rheumatoid arthritis therapy

Conditions: Rheumatoid Arthritis

Summary: this study evaluates the intestinal microbiome and disease activity in patients with rheumatoid arthritis receiving immunosuppressive therapy. patients will be analysed at two time points in reference to two predefined primary endpoints: * changes in intestinal microbiome * response to therapy the investigators want to evaluate if successful treatment of rheumatoid arthritis coincide with specific changes in the gut flora.

methotrexate (mtx) and tumor necrosis factor (tnf) -inhibitors are two efficient medications for the treatment of rheumatoid arthritis. in a substantial number of cases however, these medications remain ineffective. at present, the scientific community has limited understanding of why some patients are resistant to these medications. the purpose of this study is to understand if the gut flora may associate with treatment response. recent studies have associated rheumatoid arthritis with intestinal dysbiosis. specifically, the bacteria prevotella copri, has been associated with this disease, an observation that has been supported also by mechanistic studies. in patients receiving methotrexate, normalization of dysbiosis has been associated with successful treatment. this study is of observational character and integrated in the routine clinical care of patients with rheumatoid arthritis at the rheumatology clinic, skane university hospital, lund, sweden. study participants are asked to deliver blood and fecal sampling at two time-points together with clinical evaluation of disease activity. with an estimated inclusion of 50 patients, at least 20 responders and 20 non-responders are expected to be included and to be compared to each other. if successful treatment response in rheumatoid arthritis is associated with specific alterations of the gut flora, these results may guide future studies on the impact of dysbiosis and probiotics on this disease.

Eligibility criteria:
inclusion criteria: * rheumatoid arthritis according to the 2010 classification criteria * about to start methotrexate or tnf-inhibitor because of active disease exclusion criteria: * failure to understand protocol * a history of alcohol abuse * concomitant inflammatory bowel disease * any history of diverticulitis * a history of failure to comply with prescribed medication * ongoing biological therapy

Keywords: microbiome methotrexate tnf-inhibitor dysbiosis