Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of adalimumab in pediatric subjects with moderate to severe ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the purpose of the study is to demonstrate the efficacy and safety, and to assess the pharmacokinetics of adalimumab administered subcutaneously (sc) in pediatric subjects with moderate to severe ulcerative colitis (uc).


Eligibility criteria:
inclusion criteria: * diagnosis of uc for at least 12 weeks prior to screening, confirmed by endoscopy with biopsy. * active ulcerative colitis with a mayo score of 6 - 12 points and endoscopy subscore of 2 - 3 despite concurrent treatment with oral corticosteroids or immunosuppressants or both. exclusion criteria: * subject with crohn's disease (cd) or indeterminate colitis (ic). * current diagnosis of fulminant colitis and/or toxic megacolon. * subjects with disease limited to the rectum (ulcerative proctitis) during the screening endoscopy. * chronic recurring infections or active tuberculosis (tb).

Keywords: ulcerative colitis adalimumab
nurse-led continuum of care for people with diabetes and pre-diabetes in nepal

Conditions: Diabetes Mellitus, Type 2

Summary: the study aims to improve diabetes prevention, access to care and advocacy through a novel cost-effective nurse-led continuum of care approach that incorporates diabetes prevention, awareness, screening and management for low-income settings, and furthermore utilizes the endeavor to advocate for establishing standard diabetes program in nepal.

the purpose of this study will be to improve diabetes prevention, access to care and advocacy through a novel cost-effective nurse-led continuum of care approach that incorporates diabetes prevention, awareness, screening and management for low-income settings, and furthermore utilizes the endeavor to advocate for establishing standard diabetes program in nepal. we will conduct a two-arm, open-masked stratified cluster randomized controlled trial of a nurse-led continuum of care for people with diabetes and pre-diabetes (nucod), with primary care centers (outreach centers and government health posts) as a unit of randomization. nucod will be delivered through the trained diabetes nurses in the community to the intervention group and the outcomes will be compared to the enhanced usual-treatment group at 6 and 12 months of the intervention. the primary outcome will be change in glycated hemoglobin (hba1c) level among diabetes and progression to type 2 diabetes among pre-diabetes, and implementation outcomes measured using the re-aim (reach, effectiveness, adoption, implementation, and maintenance) framework. outcomes will be analyzed on an intention to treat basis. the results of this trial will provide information about the effectiveness of the nucod program in improving clinical outcomes for diabetes and pre-diabetes individuals, and implementation outcomes for the organization.

Eligibility criteria:
inclusion criteria: * with confirmed pre-existing type ii diabetes and prediabetes at the time of our screening (i.e., pre-existing diabetes or prediabetes) * with confirmed diagnosis of type ii diabetes or prediabetes after our community screening process (i.e., newly diagnosed diabetes and prediabetes) * is not planning to relocate outside of the current place of living in next 2 years * is older than 18 years of age exclusion criteria: * are not psychologically capable of communication * are diagnosed as type 1 diabetes

Keywords: continuum of care diabetes pre-diabetes
the role of viral infection in acute exacerbations of non-cystic fibrosis bronchiectasis in adults

Conditions: Bronchiectasis

Summary: bronchiectasis is clinically characterized by irreversible dilation of the bronchi and bronchioles leading to persistent cough, purulent sputum, and airway ﬂow limitation, which may be accompanied by recurrent exacerbations.it has been increasingly recognized that respiratory viruses are mainly responsible for acute exacerbation of chronic pulmonary diseases, i.e. asthma, chronic obstructive pulmonary disease and cystic fibrosis. however,little is known about the roles of viral infection in driving exacerbations of bronchiectasis.this study aims to identify the frequency of common viral infections and determine the roles that viruses play in acute exacerbations of bronchiectasis.

bronchiectasis is a chronic airway disease characterised by a vicious cycle of persistent bacterial colonization,inflammation and progressive tissue destruction.patients with bronchiectasis frequently developed acute exacerbations characterised by acute worsening requiring changes in concomitant use of medication,with attendant adverse effects on their morbidity and health-related quality of life. the detailed pathogenesis of exacerbations of bronchiectasis, however, remains poorly understood. recent data suggested that airway infection and inflammation are important drivers of exacerbations,therefore the imbalance between chronic bacterial infection and host immune response may result in bronchiectasis exacerbations. viral infection may be an important factor that leads to this events.it has been established that respiratory viruses are mainly responsible for the exacerbations of other chronic respiratory diseases, i.e. asthma, copd and cystic fibosis. however, the data regarding prospective studies that sought to investigate the roles of viruses in acute exacerbation of bronchiectasis are lacking. furthermore,the associations between viruses and bacteria during exacerbation need to be assessed. this study targets at indentifying the frenquency of common viral infections in adults with non-cystic fibrosis bronchiectasis and may shed light on the effects they have on clinical parameters,i.e. the length of exacerbated symptom to recovery,lung function, pulmonary inflammation, bacterial load and quality of life.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * hrct-diagnosed bronchiectasis * capable of providing written informed consent exclusion criteria: * patient judged to have poor compliance * cystic fibrosis bronchiectasis

Keywords: bronchiectasis exacerbation virus
surgical resection for hepatocellular carcinoma

Conditions: Resectable Hepatocellular Carcinoma

Summary: hepatocellular carcinoma is a type of liver cancer and is one of the leading causes of global cancer death. surgical resection of the afflicted areas of the liver is one of the treatment methods for this condition. in this retrospective research, the investigators explore the outcomes of liver resection for hepatocellular carcinoma patients undergoing liver resection from 2010 to 2021 in cipto mangunkusumo general hospital, jakarta. the main outcome is mortality and the secondary outcomes are factors predicting mortality after resection.

study design this is a retrospective cohort study. treatment of hepatocellular carcinoma patients in rscm hcc patients are managed by a multidisciplinary team (mdt) consisting of hepatologists, radiologists, pathologists, radiation oncologists, surgeons, and other specialists related to the patient's condition. confirmed hcc patients are discussed in a weekly mdt team meeting. the meeting assigned patients to treatment options according to the barcelona clinic liver center (bclc) staging system, patient preference, and other clinical considerations. resection is considered for patients at very early (bclc 0) or early (bclc a) hcc stages. this includes cp class a patients with a single tumor or less than three small (\<3 cm) tumors. patients assigned to surgical resection underwent either laparoscopic or open surgery. one to four segments of the liver were removed. tissue samples were taken for further pathologic examination. ethical clearance the ethics committee of the faculty of medicine, university of indonesia, approved this study by giving an ethical clearance with protocol number 19-11-1313. informed consent was taken from all patients.

Eligibility criteria:
inclusion criteria: * patients undergoing liver resection in cipto mangunkusumo hospital due to a confirmed diagnosis of hepatocellular carcinoma from 2010 to 2021 exclusion criteria: * patients undergoing liver resection in other hospitals were excluded, even though diagnosis or further care is done in cipto mangunkusumo hospital * patients with other malignancies * patients undergoing other treatment methods for hepatocellular carcinoma.

Keywords: carcinoma,hepatocellular liver neoplasms hepatectomy mortality prognostic
oral health and severe copd

Conditions: COPD; Periodontitis; Caries; Quality of Life; Tooth Loss

Summary: this case-control study aims to investigate the association of severe copd with oral health.


Eligibility criteria:
inclusion criteria: * patients aged ≥ 40 years and ≤ 85 years; * test group: patients with copd gold 3 and 4 with available pulmonary function test values (fev1, fvc) within the last two weeks; * control group: patients without diagnosed or self-suspected pulmonary disease matched for age, sex, smoking and number of systemic diseases to the test group; * understanding of measures performed in the study; * written informed consent. exclusion criteria: - pregnancy.
a safety and efficacy study of ads-5102 in patients with multiple sclerosis and walking impairment

Conditions: Multiple Sclerosis; Walking Impairment

Summary: this study assessed the long-term safety and tolerability of ads-5102 in subjects with ms and walking impairment who had completed the double-blind, placebo-controlled study of ads-5102 in subjects with ms (ads-amt-301).

this was a multicenter, open-label study of ads-5102 (amantadine) extended-release capsules in subjects with ms and walking impairment who completed study drug treatment for 16 weeks and completed a week 16 visit in study ads-amt-ms301. all enrolled subjects were to receive ads-5102 at 137 mg for the first week, 205.5 mg for the second week, and 274 mg for the remainder of the 52-week open-label treatment period. subjects returned to the clinic for safety and efficacy assessments at weeks 4, 24, and 52. in addition, a telephone visit for safety assessments was conducted at week 2 and week 38. subjects who withdrew from the study prior to completion of the week 52 visit had an early termination (et) visit that included safety and efficacy assessments. subjects who completed 52 weeks of open-label treatment had a final visit for post-treatment safety follow-up and efficacy assessment at week 54. all study visits and efficacy assessments were to be scheduled to occur at approximately the same time of day for each individual subject. each subject's efficacy assessment was to be performed by the same clinical rater, if possible.

Eligibility criteria:
inclusion criteria: * signed a current irb-approved informed consent form * successful completion of a prior double blind study of ads-5102 in patients with ms walking impairment. exclusion criteria: * based on the judgment of the investigator or medical monitor, participation in the study would jeopardize the safety of the subject. * if female, is pregnant or lactating * if a sexually active female, is not surgically sterile or at least 2 years post-menopausal, or does not agree to utilize a highly effective hormonal method of contraception (an iud, or vasectomized male partner is also acceptable), in combination with a barrier method, from baseline through at least 4 weeks after the completion of study treatment. if a sexually active male, does not agree to utilize condoms from screening through at least 4 weeks after the completion of study treatment. * anticipated treatment with any amantadine formulation other than ads-5102 * planned participation in another interventional clinical trial
multicenter assessment of the safety and efficacy of the minnow medical grst™ peripheral catheter system

Conditions: Peripheral Vascular Disease

Summary: the objective of this clinical investigation is to evaluate the safety and efficacy of the minnow medical grst™ peripheral catheter system in the treatment of de novo lesions in the superficial femoral artery (sfa) or the popliteal artery.


Eligibility criteria:
inclusion criteria: 1. patient is ≥18 of age. 2. patient is rutherford category 2-4. 3. de novo single lesion with a diameter stenosis (%ds) of ≥50% 4. target lesion is a de novo occlusion that can be successfully pre-dilated resulting in a lesion of \<99%. 5. target lesion stenosis has a length of ≤100 mm based on visual assessment. 6. target vessel reference diameter is ≥3.0 mm and ≤7.0 mm based on visual assessment. 7. angiographic evidence of distal runoff defined as minimum one patent tibial artery with a straight flow to the foot. 8. patient is willing and able to provide written informed consent prior to any study specific procedure. 9. patient is willing and able to comply with specified follow-up evaluations at the specified times. exclusion criteria: 1. prior pta in the intended target lesion including 10 mm proximal or distal from the intended treatment area. 2. evidence of thrombus in the target vessel. 3. prior ipsilateral or contralateral lower limb arterial bypass. 4. treatment of ipsilateral lesions during the index procedure or planned treatment after the index procedure. 5. target lesion is severely calcified. 6. any known allergies and / or intolerances to the following: asa, clopidogrel, heparin, contrast agents (that cannot be adequately pre-medicated). 7. any planned surgery within 30 days of the study procedure. 8. renal failure (serum creatinine \> 2.0 mg/dl). 9. female with childbearing potential without a negative pregnancy test. 10. patient has had an organ transplant. 11. patient is currently participating in an investigational drug or device study which has not reached the primary endpoint yet or which clinically interferes with the endpoints of this study. 12. in the investigator's opinion, the patient has a severe co-morbid condition(s) that could limit the ability to participate in the study.

Keywords: peripheral vascular disease peripheral artery disease radiofrequency
anxiety and depression among gendarmes posted to french guiana

Conditions: Anxiety Depression Disorder

Summary: this is a mixed-method, single-center study involving two concurrent phases: a quantitative phase with an anonymous self-administered questionnaires, and a qualitative phase with individual contextual interviews and a focus group. the hypothesis underlying this study is that isolated postings are a risk factor for anxiety-depressive disorders. the aim of this study is to provide new information to help propose targeted prevention and health promotion measures.


Eligibility criteria:
inclusion criteria: * gendarme in active position * age over 18 * assignment in french guiana for more than 6 months at the time of the study * not opting for study participation exclusion criteria: * previously diagnosed psychiatric condition * people with a reading/writing disability in the french language * major incapacity
frozen red blood cell transfusions in trauma patients

Conditions: Blood Loss; Anemia; Trauma

Summary: the purpose of this study is to look at red blood cell (rbc) transfusions in trauma patients and evaluate for any differences between the age of the rbcs and how they were stored. the investigators will specifically look for the following differences between study groups: 1. the transfused red blood cells' ability to delivery oxygen to the tissues 2. differences in biochemical markers in subjects and units transfused, and 3. how the subject's internal organs are working and if they develop any infections


Eligibility criteria:
inclusion criteria: * trauma service with an injury severity score \> 4 * require a blood (prbc) transfusion * transfusion is not emergent * able to obtain consent from patient or appropriate 3rd party prior to 1st transfusion exclusion criteria: * inability to adhere to blood age randomization due to limitations of the blood bank inventory * bilateral hand injuries that prevent sto2 measurements * age \< 15 * pregnancy * massive transfusion (=/\> 10 units in 24 hours) in last 3 months * hemodynamically unstable or need for transfusion in \< 3 hours

Keywords: frozen red blood cells transfusion trauma
research on the clinical characteristics and key diagnosis and treatment technology of genetic and metabolic liver disease

Conditions: Diagnosis ， Treatment， Genetic and Metabolic Liver Disease

Summary: 1. establish a follow-up cohort of genetic and metabolic liver disease in the chinese population, and carry out research on disease spectrum, clinical characteristics and personalized diagnosis and treatment to improve the level of diagnosis and treatment. 2. establish a multidisciplinary collaborative diagnosis and treatment model of genetic metabolic liver disease, develop and promote diagnosis and treatment paths, and improve the diagnosis and treatment ability of genetic metabolic liver disease in beijing and even the whole country. 3. establish a new crispr gene diagnosis technology to realize fast and low-cost genetic testing. 4. elucidating the genetic mutation spectrum of common genetic and metabolic liver disease in china is helpful to accurate gene diagnosis and functional research. 5. study the genotype-phenotype, mutation and clinical outcome relationship and influencing factors of the common genetic and metabolic liver disease population in china, to guide the early diagnosis, early treatment and improve the prognosis.


Eligibility criteria:
inclusion criteria: meet the diagnostic criteria of each disease. exclusion criteria: 1. co-infected with hepatitis b virus, hepatitis c virus and hiv; 2. patients with liver fibrosis and cirrhosis caused by other causes; 3. patients with alcoholic liver disease and autoimmune liver disease; 4. liver malignancy has been suggested or confirmed by evidence; 5. combined with other serious systemic diseases.
transvaginal pelvic ultrasound in the ed

Conditions: Abdominal Pain; Pelvic Pain

Summary: pelvic ultrasound is frequently performed in the ed in non-pregnant women to assess for ovarian pathology, though its use has not been described in the medical literature. this observational study aims to describe its use in clinical ed practice.

pelvic ultrasound is frequently performed in the ed in non-pregnant women to assess for ovarian pathology. during the pelvic examination a transvaginal ultrasound probe is used to visualize ovarian size, determine echotexture, assess whether ovarian tenderness is present, and sometimes measure ovarian blood flow. though pelvic ultrasound is used in the hennepin county medical center ed routinely, there is a paucity of literature assessing it's utility. this observational study will help determine the usefulness of this imaging modality, and how often it changes management in clinical practice. specifically, this study will attempt to determine how often transvaginal ultrasound identifies the structures of interest, and then will correlate these findings with the final ed diagnosis. if a formal ultrasound is obtained, the findings of the ed ultrasound will also be compared to the findings of the formal ultrasound. the treating physicians will be queried the diagnosis and management plans before and after the pelvic us to ascertain changes in management.

Eligibility criteria:
inclusion criteria: * age \>= 18 years old female * ed bedside transvaginal ultrasound to be performed in a non-pregnant woman with at least one ovary * willing to discuss how they are doing at 7-10 days via phone * valid phone number exclusion criteria: * if a diagnosis of ovarian torsion, mass, toa or other ovarian pathology is known before ed ultrasound * previously enrolled in this study

Keywords: pelvic ultrasound transvaginal ultrasound
patient preferences for breast reconstruction after mastectomy

Conditions: Breast Cancer

Summary: deciding whether or not to have breast reconstruction after mastectomy is highly challenging for many patients. this study will examine patients' decisions about reconstruction and the effects of reconstruction on quality of life and body image.

breast reconstruction after mastectomy is an important treatment option for the many thousands of women who undergo mastectomy each year. its insurance coverage is mandated by federal law. many women who want reconstruction, particularly women from racial and ethnic minorities, never receive it, and some women who undergo reconstruction regret having it, raising concern about the quality of decisions about the procedure. little is known about the quality of breast reconstruction decisions, defined as the extent to which decisions are informed and concordant with patients' preferences. a lack of reliable methods for evaluating preference concordance has resulted in a paucity of research in this area. deciding about breast reconstruction requires a patient to predict how she would feel after the procedure, a process called affective forecasting. extensive psychological research has shown that people have difficulty making accurate predictions about how they will feel, tending to overestimate the effects of disease and treatments on their well-being and to underestimate their ability to adapt to change and the effects of other aspects of their lives. despite the importance of affective forecasting to decisions about breast reconstruction, no research has examined this aspect of those decisions. the investigator proposes to conduct a pilot cohort study of breast cancer patients undergoing mastectomy, with or without reconstruction with the following specific aims: aim 1: to evaluate whether patients make informed decisions about breast reconstruction that are concordant with their preferences; aim 2: to assess the accuracy of patients' preoperative predictions about their post-operative body image and well-being; and aim 3: to assess the effects of breast reconstruction on quality of life and body image and the potential modification of those effects by preference concordance.

Eligibility criteria:
inclusion criteria: * women 21 years of age or older * having a mastectomy at unc for treatment of stage i, ii, or iii breast cancer, ductal carcinoma in situ (dcis) or for prophylaxis exclusion criteria: * stage iv breast cancer * women who do not speak english * severe psychiatric illness

Keywords: breast cancer unc lineberger breast reconstruction mastectomy