Kornimate/medical-research-clean huggingface dataset:
cross-over study to investigate retinal function following administration of a single dose of azd9056

Conditions: Rheumatoid Arthritis

Summary: the purpose of the study is to determine whether treatment with a single 800mg dose of azd9056, a medication which has been developed as a possible treatment for rheumatoid arthritis, has an effect on the function of the retina


Eligibility criteria:
inclusion criteria: * volunteers must be able to undergo the electroretinography assessments * volunteers must have an intra ocular pressure of less than 25mmhg and 6/6 vision exclusion criteria: * volunteers must pass a test that assesses whether they are at risk of narrow angle glaucoma * volunteers must not a family history of colour blindness, they must also pass a colour blindness test * volunteers must not have a history or current neurological or opthalmological (eye) disease

Keywords: electroretinography rheumatoid arthritis anti-tnf disease modifying anti-rheumatic drugs (dmard)
high-risk influenza vaccine alert

Conditions: Influenza

Summary: the purpose of this study is to assess, prospectively, the effect on flu vaccination rates of salient alerts in the electronic health record that indicate a patient's high risk for flu and its complications. the investigators hypothesize that the salient alerts will lead to increased flu vaccination compared with a standard flu alert.

the cdc (centers for disease control) recommends a flu vaccination to everyone aged 6+ months, with rare exception; almost anyone can benefit from the vaccine, which can reduce illnesses, missed work, hospitalizations, and death. one barrier to vaccination is a lack of "cues to action," and, in particular, the lack of direct recommendation from medical personnel; this barrier is arguably the most effectively overcome by a simple nudge of clinicians, compared with barriers such as negative attitudes toward vaccination, low perceived utility of vaccination, and less experience with having received the vaccine. geisinger partnered with medial earlysign (medial) to develop a machine learning (ml) algorithm to help identify people at risk for serious flu-associated complications based on existing electronic health record data. eligible at-risk patients will be randomized to an active control group (clinician will be shown a standard flu alert) or one of two experimental groups (clinician will be shown an alert indicating patient's high risk, with or without describing the patient's factors contributing to that risk).

Eligibility criteria:
patient inclusion criteria: * age 18+ * have been determined to be in the top 20% of risk through medial's ml algorithm * attend an appointment where the flu alert fires (geisinger sets when flu alerts start and end--between \~9/1/2022 and \~4/30/2023, as well as the trigger conditions for the alert, which includes valid departments and visits and excludes contraindications like guillain-barre syndrome) clinician inclusion criteria: * any geisinger clinician who sees patient-participants in our study for an appointment where their flu shot alert fires

Keywords: vaccination health promotion health behavior reminder systems economics, behavioral risk assessment
mil familias-santa barbara's operational pilot to understand diabetes in the latino community

Conditions: Type2 Diabetes Mellitus; Cardiovascular Diseases

Summary: the mil familias program is a 10-year initiative to reduce the burden of cardio-metabolic disease among latino families in the central coast of california. the mil familias program involves enrolling 1000 latino families with at least one member in the family having type 2 diabetes, measuring the 5 determinants of human health: genetics, biology, behavior, psychology and environment, training latino community health workers ("especialistas") , creating a living information (bio)bank and planning culturally-relevant interventions.

the mil familias pilot study aims to develop, operationalize and refine methods to both recruit and collect data from 100 adult participants pertaining to the 5 determinants of human health: genetics, biology, behavior, psychology and environment. specially-trained latino and bilingual community health workers known as "especialistas" will be used to help gather data and to serve as the participants trustworthy health companion. over 100 variables of information pertaining to the 5 determinants of human health (as listed above) will be gathered and stored to create a living information (bio)bank particular to latinos. the ultimate goal of this research is to provide the target population with effective, culturally-relevant interventions that are geared toward population specific needs.

Eligibility criteria:
inclusion criteria: 1. males or females ≥ 18 years of age at visit 1 (screening and enrollment). 2. self-reported hispanic and/or latino heritage. 3. currently residing in santa barbara county, california. 4. established diagnosis of type 2 diabetes for at least one year prior to enrollment date. 5. signed and dated written informed consent by the date of visit 1. 6. based on the research staff's judgment, subject must have a good understanding, ability, and willingness to adhere to the protocol, including performance of self-monitored data collection during the wearable device portion. exclusion criteria: 1. diagnosed severe cardiovascular disease, within the 6 months prior to enrollment visit 1, defined as: previous stroke; decompensated heart failure new york heart association class iii or iv; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty. 2. life expectancy \< 2 years. 3. any active clinically significant disease or disorder, which in the investigator's opinion could interfere with the participation of the trial. 4. mental incapacity, psychiatric disorder, unwillingness or language barriers precluding comprehension of study activities and informed consent. 5. participation in other trials involving medication or device within 1 month prior to visit 1. 6. known or suspected abuse of alcohol, narcotics, or illicit drugs.

Keywords: type 2 diabetes cardio-metabolic disease latino hispanic especialista
identification of genetic factors implicated in orofacial cleft using whole exome sequencing

Conditions: Cleft Lip and Palate

Summary: despite significant progress made in identification on numerous genes and gene pathways critical for craniofacial development, several approaches, ie mutation screening of specific candidates, association studies and even genome-wide scans have largely failed to reveal the molecular basis of ns human clefting

despite significant progress made in identification on numerous genes and gene pathways critical for craniofacial development, several approaches, ie mutation screening of specific candidates, association studies and even genome-wide scans have largely failed to reveal the molecular basis of ns human clefting. moreover, the efficiency of whole exome sequencing -wes- was proven. the efficiency of wes was proven by the identification of the genes causing freeman sheldon and miller's syndrome, followed by several others. in the picardy region, management and follow-up of orofacial cleft patients are well-organised by a multidisciplinary team in the university hospital of amiens. the investigators therefore decided to perform whole exome sequencing (wes) on precisely phenotyped non-syndromic cl/p patients followed in our center.

Eligibility criteria:
inclusion criteria: * subject with a nscl/p or cl/p of unknown etiology, * national health care insurance holders exclusion criteria: * subject with a cl/p of known etiology, * subject with a nscl/p and an irf6 mutation

Keywords: cleft lip and palate cl/p wes
a study to evaluate the performance of the depuy low contact stress (lcs®) complete anterior-posterior glide (apg) mobile bearing knee

Conditions: Osteoarthritis

Summary: the primary objective of this investigation is to determine the survivorship of the lcs complete ap glide mobile bearing knee prosthesis at 5 years. the secondary objectives of this investigation are to evaluate the clinical performance of the lcs® complete ap glide mobile bearing knee prosthesis and to determine its long-term survivorship.


Eligibility criteria:
inclusion criteria: * male or female subjects, aged between 45 and 85 years inclusive. * subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained. * subjects who present with any pathology that in the opinion of the clinical investigator requires a primary total knee arthroplasty. * subjects who have an intact posterior cruciate ligament and well functioning medial and lateral collateral ligaments. * subjects who in the opinion of the clinical investigator are considered to be suitable for treatment with the lcs complete ap glide mobile bearing knee system, according to the indications specified in the package insert leaflet. exclusion criteria: * subjects who, in the opinion of the investigator, have an existing condition that would compromise their participation and follow-up in this study. * revision of an existing knee implant (including unicompartmental implants). * female subjects who are pregnant. * subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes. * subjects who have participated in a clinical study with an investigational product in the last month (30 days). * subjects who are currently involved in any personal injury litigation claims. * subjects involved in personal medical-legal claims. * subjects with a known history of poor compliance to medical treatment.

Keywords: arthroplasty, replacement, knee, lcs complete apg (mesh);
prevention and treatment of cinv caused by tc regimen in gynecological malignant tumor patients

Conditions: Gynecological Tumor

Summary: to determine the best method to prevent cinv caused by tc regimen in patients with gynecological malignant tumor.

the risk of vomiting caused by high-dose carboplatin is controversial, and there is currently no prevention of tc in patients with gynecological malignant tumors high-level evidence-based medical evidence for programme-induced cinv. therefore, different guidelines recommend the best antiemetic regimen as well it's different. this study is intended to conduct a prospective, multicenter, randomized, double-blind, placebo-controlled, crossover study the designed phase iii clinical study provides important data and basis for clinical practice and guideline formulation.

Eligibility criteria:
inclusion criteria: 1. age 20-75 years old; 2. ecog ps：0～2; 3. she was diagnosed as gynecological malignant tumor and was to receive tc chemotherapy; 4. carboplatin auc 5～6mg/ml/min； 5. basically normal organ function (normal bilirubin level circumference, normal range of creatinine, alt\&lt; 2 times the upper limit of normal, ast\&lt; 2 times the upper normal value) exclusion criteria: 1. patients with previous history of chemotherapy, radiotherapy or targeted therapy; 2. malignant tumors with brain metastases; 3. history of gastrointestinal malignancy; 4. history of brain tumor; 5. previous gastrointestinal surgery history, such as segmental resection, (partial) gastrectomy, except intestinal polyp resection and appendectomy; 6. (incomplete) intestinal obstruction; 7. vestibular dysfunction; 8. massive abdominal accumulation liquid (except for those who have undergone puncture drainage); 9. opioid concomitant drug users; 10. diabetic.
genotype-directed neoadjuvant chemoradiation for rectal carcinoma

Conditions: Rectal Carcinoma

Summary: determine if genotype-directed neoadjuvant chemoradiation, using information from the thymidylate synthase promoter polymorphism, result in a greater degree of tumor downstaging in high risk patients compared to historical controls.


Eligibility criteria:
inclusion criteria: * biopsy proven adenocarcinoma of the rectum * lesion evaluated by surgeon and found to be resectable * stage t3 or t4 disease on radiography or ultrasound * karnofsky performance status at \>60 * laboratory criteria: * absolute neutrophil count \>= 1.5 k * platelets \>= 100 k * total bilirubin \<= 2.0; * sgot and alkaline phosphatase \<= 2 x upper limit of normal * creatinine \< 2.0 * informed consent signed * patients with distant metastatic disease will be eligible if they satisfy all other conditions. exclusion criteria: * pregnant women, children \< 18 years, or patients unable to give informed consent * patients with a past history of pelvic radiotherapy. * patients with prior malignancy in the past 5 years except: skin cancer or in-situ cervical cancer. however, patients with synchronous adenocarcinomas are eligible provided either (a) the synchronous adenocarcinoma was in a removed pedunculated polyp and did not invade the stalk or (b) the synchronous adenocarcinoma was in a removed polyp that lay within the surgical field (extent of resection would not be changed) or (c) the synchronous adenocarcinoma is smaller than the index rectal cancer and lies completely within the radiation field (clinically favorable second lesion and the extend of radiation and surgery would not be changed). * patients with known allergy to 5-fluorouracil or irinotecan

Keywords: rectal rectum cancer carcinoma
amniotic biomarkers for the prediction of postpartum renal function.

Conditions: Nephropathy

Summary: the discovery of antenatal bilateral renal anomaly poses an essential question: can we predict postnatal renal function? ultrasound is insufficiently precise to predict postnatal renal function evolution. the objective of this study is to estimate the specificity and sensitivity of amniotic fluid biomarkers to predict postnatal renal function in fetuses with bilateral developmental nephropathies. both fetuses with bilateral renal anomalies and control (healthy) fetuses will be included. for this study amniotic fluid will only be collected according to routine clinical practice and only excess amniotic fluid sample will be used for the study. the potentially identified biomarkers will not change routine management of the pregnancies in the study.


Eligibility criteria:
inclusion criteria: all fetuses with a bilateral abnormal renal development (structure modification of the parenchyma with or without urinary tract abnormalities associated) the following sonographic criteria are used: * fetal kidney size \ 97.5ep or\> 2 sd defining nephromegaly * and / or hyperechogenicity (more echogenic than the liver kidney) * and / or cysts * and / or abnormal cortico-medullary differentiation (decrease or lack thereof) * and / or bilateral cortical thinning * and / or the possibility of an initial unilateral renal disease in the case of a pathology on which kidney damage is usually to become bilateral during evolution exclusion criteria: * foetuses with severe malformations that can change the amniotic or urine proteome: complex heart disease, digestive stenosis, fetal immobility. * fetus whose mother has chronic infectious diseases (hiv, hepatitis b and c) or acute infectious diseases such chorioamnionitis. * parental refusal.
focus groups in ethnically and racially diverse families

Conditions: Attention Deficit/Hyperactivity Disorder; Emotional Dysfunction; Irritable Mood

Summary: focus groups to identify treatment needs and barriers to participation in the planned multinutrient study among racially and ethnically diverse (black and hispanic) communities.

focus group purpose is to understand parents' priorities regarding their child's mental health, and facilitators or barriers to research participation generally, with inquiry about cih intervention use, and the multinutrient feasibility study specifically. researchers will engage black and hispanic families in focus groups to discuss mental health priorities related to their children, and real or perceived barriers to engagement in research studies. the feedback will inform the final design and recruitment for the multinutrient feasibility study in black and hispanic populations. one group will comprise individuals who self-identify as hispanic, another, as black, in order to create space to hear perspectives that may differ between broadly defined groups.

Eligibility criteria:
inclusion criteria: * adult parents/caregivers self-identified as black or hispanic/latino * with a family member 6-18 years old with suspected adhd and/or emotional dysregulation, or provide care for, or teach someone who meets these criteria * who have sought or are interested in treatment * willing to discuss child's mental health care needs and provide feedback regarding feasibility study * able to attend focus groups in person * able to communicate in english or spanish * agree to focus group session audio recording exclusion criteria: * unwilling to be recorded
the role of genetic factors in the development of arterial hypertension in the kazakh population

Conditions: Arterial Hypertension

Summary: this is a gwas study that aims to identify possible candidate genes associate to arterial hypertension by exploring single nucleotide polymorphism (snp) in a group of arterial hypertension, in the kazakh population. the investigators hypothesize that the careful phenotyping of the subject sand matching with increase the power to find snp significantly associate with arterial hypertension

a genome-wide association study (gwas) is an approach used in genetics research to associate specific genetic variations with particular diseases. the method involves scanning the genomes from many different people and looking for genetic markers that can be used to predict the presence of a disease. once such genetic markers are identified, they can be used to understand how genes contribute to the disease and develop better prevention and treatment strategies.

Eligibility criteria:
inclusion criteria: * persons with confirmed arterial hypertension; * the age of patients is from 18 to 55 years old inclusive; * persons of kazakh nationality, whose paternal and maternal grandparents identify themselves as kazakhs; * persons who are able and willing to provide written informed consent; * persons capable and willing to comply with the research protocol; exclusion criteria: * persons under 18 and over 55; * persons who, in the opinion of the researcher, are mentally or legally incapacitated, which prevents obtaining informed consent; * pregnant or lactating women; * tuberculosis of any localization in the active phase and in history; * severe and decompensated diseases of the liver and kidneys, cardiovascular system; * severe and decompensated course of endocrine diseases; * autoimmune diseases; * systemic diseases; * cancer.

Keywords: gwas
evaluation of subepithelial connective tissue graft versus acellular dermal matrix with tunnel technique in treatment of multiple gingival recessions

Conditions: Gingival Recession

Summary: the goal of the present study is to compare the amount of root coverage resulting from subepithelial connective tissue graft and acellular dermal matrix associated with tunnel technique among patients suffering from multiple gingival recession.

acellular dermal matrix with tunnel technique will offers great advantages for patients with multiple gingival recession as regards decrease surgical time, post-operative pain and root coverage, clinical attachment level, width of keratinized gingiva, gingival biotype compared to subepithelial connective tissue graft with tunnel technique.

Eligibility criteria:
inclusion criteria: * subjects with facial multiple gingival recession defects classified as either class i or ii defects according to miller's classification (miller 1985). * subjects aged between 18 - 60 years old. * patients should be free from any systemic disease that may affect normal healing of tissue, and predictable outcome. * patients with good oral hygiene. exclusion criteria: * current and former smokers. * pregnant females. * subjects received any periodontal therapy for minimum of 6 months prior to the study. * subjects taking drugs known to interfere with wound healing. * subjects with unacceptable oral hygiene with plaque index \>2. * teeth with non-carious cervical lesions (nccl), cervical caries and malalignment.
iron isomaltoside/ferric derisomaltose vs iron sucrose for the treatment of iron deficiency anemia (ida)

Conditions: Iron Deficiency Anaemia; Iron Deficiency Anemia

Summary: evaluate safety and efficacy of iron isomaltoside/ferric derisomaltose (monofer®/monoferric®) compared with iron sucrose (venofer®), in subjects diagnosed with ida.

ida is highly prevalent condition in subjects with cancer and gastrointestinal diseases such as inflammatory bowel diseases, menstruating or pregnant women, and subjects who have undergone bariatric procedure or surgery. ida can have a substantial medical and quality of life (qol) burden. treatment of subjects diagnosed with ida includes controlling the bleeding and replenishing lost iron. this study was designed to evaluate the safety and efficacy of iron isomaltoside/ferric derisomaltose compared with iron sucrose in subjects diagnosed with ida. in a subfraction of 35 subjects treated with iron isomaltoside/ferric derisomaltose, ecg and iron will be frequently measured. the study subjects received either a single intravenous (iv) dose of iron isomaltoside/ferric derisomaltose (1000 mg at baseline) or iron sucrose (200 mg iv injections at baseline and repeated according to standard practice or physician choice up to a maximum of five times within the first two weeks starting at baseline; a cumulative dose of 1000 mg was recommended). the study subjects were monitored for up to 8 weeks from baseline.

Eligibility criteria:
inclusion criteria includes: 1. men or women ≥ 18 years 2. subjects having ida caused by different etiologies 3. subjects with intolerance to oral iron therapy or a need for rapid repletion of iron stores: 4. haemoglobin (hb) ≤ 11 g/dl 5. transferrin saturation (tsat) \< 20 % 6. s-ferritin \< 100 ng/ml 7. willingness to participate and signing the informed consent form exclusion criteria includes : 1. anemia predominantly caused by factors other than ida 2. hemochromatosis or other iron storage disorders 3. previous serious hypersensitivity reactions to any iv iron compound 4. erythropoiesis stimulating agent (esa) treatment 5. prior to screening or during the trial period; has or will be treated with a red blood cell transfusion, radiotherapy, and/or chemotherapy 6. will require a surgical procedure that necessitated general anesthesia prior to screening or during the trial period 7. alanine aminotransferase and/or aspartate aminotransferase \> 3 times upper limit of normal 8. required dialysis for treatment of chronic kidney disease (ckd) 9. alcohol or drug abuse within the past 6 months 10. pregnant or nursing women

Keywords: iron deficiency anaemia iron deficiency anemia ida intravenous iron replacement therapy iron isomaltoside ferric derisomaltose monofer monoferric monover monofar monoferro
oto-201 for middle ear effusion in pediatric subjects requiring tympanostomy tube placement

Conditions: Bilateral Middle Ear Effusion Requiring Tympanostomy Tube Placement

Summary: the purpose of this study is to describe the safety and tolerability of two dose levels of oto-201, placebo and sham when administered intra-operatively in pediatric subjects with bilateral middle ear effusion who require tympanostomy tube placement.


Eligibility criteria:
inclusion criteria includes, but is not limited to: * subject is a male or female aged 6 months to 12 years, inclusive * subject has a clinical diagnosis of bilateral middle ear effusion requiring tympanostomy tube placement * subject's caregiver is willing to comply with the protocol and attend all study visits exclusion criteria includes, but is not limited to: * subject has a history of prior ear or mastoid surgery, not including myringotomy or myringotomy with tympanostomy tube placement * subject has a history of sensorineural hearing loss * subject has a history of chronic or recurrent bacterial infections other than otitis media that likely will require treatment with antibiotics during the course of the study