Kornimate/medical-research-clean huggingface dataset:
the epidemiology of recurrent spontaneous abortion associated with thrombophilla

Conditions: Recurrent Pregnancy Loss

Summary: rsa is a multifactorial disorder resulting from genetic factors, anatomic factors, autoimmune disorders, endocrine dysfunction, thrombophilia, life style factors, and maternal infections. however, the underlying causes remain undetermined in up to 50% of cases. in this clinical cohort study, we intended to get an epidemiological evidence for patients with recurrent spontaneous abortion associated with thrombophilla.


Eligibility criteria:
inclusion criteria: * woman who had 2 miscarriages before 12(th) week of gestation.signed consent form. exclusion criteria: 1. having experienced severe allergies, trauma history and/or operation history within 3 months; 2. with a history of mental illness and/or family history of mental illness 3. limb disabled 4. taking medicine within one month 5. suffering major events or having mood swings 6. with a history of recurrent pregnancy loss 7. having internal and surgical disease(after having variety of physical examination such as electrocardiogram/hepatic and renal function/blood routine and urine routine) 8. chromosome aberrations in anyone of the couple.
study of combination therapy with mogamulizumab (kw-0761) and nivolumab (ono-4538/bms-936558) in subjects with advanced solid tumors

Conditions: Solid Tumor

Summary: the purpose of this study is to characterize the safety and tolerability and determine the maximum tolerated dose (mtd) or the recommended fixed dose of the combinations of mogamulizumab and nivolumab in subjects with locally advanced or metastatic solid tumors.


Eligibility criteria:
inclusion criteria: * subjects who voluntarily signed and dated institutional review board approved informed consent form in accordance with regulatory and institutional guidelines. * subjects who have progressed or have been intolerant to any standard treatment regimen or refused standard treatment, or for which adequate standard therapy does not exist. * subjects who have evaluable lesion per guideline of response evaluation criteria in solid tumors (recist) version 1.1. * subjects with life expectancy \> 12 weeks. * subjects with eastern cooperative oncology group (ecog) performance status 0 - 1. * potential child-bearing female who has agreed with contraception and not breast-feeding. for male who also has agreed with contraception. * subjects who have adequate hematological, renal, hepatic and respiratory functions defined. * must agree to present archival tumor tissues to sponsor or be willing to undergo a pre-treatment biopsy. * histologically or cytologically confirmed locally advanced or metastatic solid tumors. exclusion criteria: * female subjects who are pregnant or breast-feeding. * subjects with uncontrolled and significant inter-current illness. * subjects with known central nervous system (cns) metastases and/or carcinomatous meningitis. * subjects who have been previously treated with an anti-programmed death 1 (pd-1), anti-pd-l1, anti-pd-l2, anti-cd137, or anti-cytotoxic t-lymphocyte-associated antigen-4 (ctla-4) antibody or any other antibody or drug specifically targeting t-cell co-stimulation or checkpoint pathways. * subjects who have been previously treated with mogamulizumab. * subjects with any prior grade ≥ 3 immune-related adverse event (irae) while receiving any previous immunotherapy agent, or any unresolved irae. * subjects with a history of severe hypersensitivity reactions to drugs. * subjects who have been received chemotherapies, immunotherapy, biologic or hormonal therapies, another investigational drug, radiation or major surgery for cancer treatment within 28 days or 42 days (for nitrosourea or mitomycin c) prior to cycle 1 day 1. * subjects who have known active autoimmune disease or syndrome. * subjects who have active inflammatory bowel disease, irritable bowel disease, celiac disease, or other serious gi chronic conditions associated with diarrhea.
effect of exenatide on 24-hour blood glucose profile compared with placebo in patients with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to test the hypothesis that in patients with type 2 diabetes, the addition of exenatide will result in lower time-averaged serum glucose during a 24-hour period, compared with placebo.


Eligibility criteria:
inclusion criteria: * subject has an hba1c between 7.0% and 10.0%, inclusive. * subject has a body mass index (bmi) \>25 kg/m\^2 and \<50 kg/m\^2. * subject is on a stable dose of metformin or metformin plus a thiazolidinedione. exclusion criteria: * subject has been treated with any of the following medications: \*exogenous insulin for more than 1 week within 3 months of screening, \*sulfonylureas or meglitinides within 2 months of screening, \*alpha-glucosidase inhibitors within 2 months of screening, \*pramlintide acetate injection within 2 months of screening. * subject has received exenatide, glp-1 analogs, dpp-iv inhibitors, or has participated in this study previously.

Keywords: exenatide diabetes amylin lilly
incidence and risk factors of venous thrombosis of the lower limbs after hospitalization in medical patients at risk

Conditions: Patients Hospitalized for More Than 48 Hours; Acute Medical Illness

Summary: in tunisia, the available data are limited regarding the incidence of venous thrombosis of the lower limbs (tvmi) post-hospitalization, whether symptomatic or subclinical. the thromboprophylactic strategy will certainly depend on the incidence of this complication and its severity. in this study, we performed a systematic screening for tvmi in a well-characterized cohort of patients discharged after hospitalization \>48h for an acute medical condition.

this is a prospective follow-up of patients after hospitalization for more than 48 hours 6 weeks after discharge. the study must be approved by the ethics committee and all patients will have given their written informed consent.

Eligibility criteria:
inclusion criteria: * patients included adults aged at least 40 years old * hospitalized for more than 48 hours for an acute medical illness (i.e. heart failure, active cancer, acute ischemic stroke, infectious diseases, inflammatory disease and respiratory failure acute) * patients at risk of mivt due to moderate or severe immobility, history of thrombophilia (factor c or s deficiency, etc.), body mass index of 30 kg/m2. exclusion criteria: * hospitalised for less than 48 * patients who required intensive care, patients with cognitive impairment, patients admitted for sars-cov-2 infection or patients with a hospital stay \<2 days, patients with a pre-existing reason for anticoagulation (therapeutic), such as atrial fibrillation or etd and patients in whom mivt is discovered on first ultrasound examination upon discharge from hospital.

Keywords: mte
mobile app for improving adherence of rivoxaban (rivox-af)

Conditions: Atrial Fibrillation

Summary: rivox-af study is a prospective, multicenter, randomized controlled study in which patients with af are allocated to medication-app group or conventional treatment group. the app based feed-back algorithm will provide the patients with check taking drug or reminding of taking drug.


Eligibility criteria:
inclusion criteria: * patients with af aged 19 years or older with one or more comorbidities including heart failure, myocardial infarction, stable angina, hypertension or diabetes mellitus (patients can be enrolled 3 months after myocardial infarction or percutaneous coronary intervention). * patients who already took or plan to take rivoxban * patients who able to use smart phone exclusion criteria: * creatinine clearance \<15ml/min * moderate or severe mitral stenosis * mitral valve operation history * current alcohol abuse or alcohol abus history * not eligible for study due to legal or psychiatric problem * enrolled other clinical study within 4 weeks * declined to enroll the study

Keywords: atrial fibrillation mobile app
abcb1 snps as predictors of pipn

Conditions: Paclitaxel Adverse Reaction; Neuropathy;Peripheral; Breast Cancer

Summary: the study aim is to determine the allele frequencies of 1236 g\>a and 3435 g\>a in abcb1 and study their association with the incidence and severity of paclitaxel-induced peripheral neuropathy while adjusting for other baseline covariates in egyptian patients. additionally, the study aimed at fitting and validating logistic regression models with the aforementioned snps evaluated in additive, dominant, overdominant, and recessive genetic models and performing diagnostics for the best model in terms of internal validity.


Eligibility criteria:
inclusion criteria: 1. egyptian females ≥18 years of age. 2. histologically confirmed breast cancer. 3. receiving conventional neoadjuvant or adjuvant weekly paclitaxel. 4. eastern cooperative oncology group (ecog) performance status of 0-2. 5. adequate organ reserves ((serum creatinine ≤1.5x upper normal limit (unl), total bilirubin ≤1.5x unl, absolute neutrophil count ≥1.5 x 10\^9/l, platelet count ≥100 x 10\^9/l, ast and alt ≤3.0x unl, and alkaline phosphatase ≤3.0x unl). 6. no major neurological disease or symptoms prior to the start of paclitaxel therapy. 7. neither subjective nor objective evidence of metastatic disease. exclusion criteria: 1. pregnancy. 2. patients with recurrent or metastatic (local or distant) breast cancer. 3. neuropathic at the time of recruitment. 4. history of neuropathy prior to recruitment. 5. previously exposed to taxanes or any other microtubule inhibitors, or regimens including platinates. 6. patients currently receiving dose-dense biweekly taxane-containing regimens.
prostaglandin metabolite in urine samples from patients with ovarian cancer

Conditions: Ovarian Cancer

Summary: rationale: measuring the amount of prostaglandin metabolite in urine samples and studying tissue samples in the laboratory from patients with ovarian cancer may help doctors identify and learn more about biomarkers related to ovarian cancer and may help the study of cancer in the future. purpose: this laboratory study is measuring the amount of prostaglandin metabolite in urine samples from patients with ovarian cancer.

objectives: * determine the level of prostaglandin e_2 metabolite (pge-m) in 24-hour urine samples collected prior to surgery or chemotherapy from patients with ovarian cancer. * determine cyclooxygenase-1 (cox-1) and cyclooxygenase-2 (cox-2) expression by western blot and immunohistochemistry (ihc) in ovarian tumor tissue samples and matched normal ovarian tissue samples, if available, from these patients. * correlate urine pge-m levels with corresponding tissue cox-1 and cox-2 levels in urine and tissue samples from these patients. outline: this is a pilot study. patients submit 24-hour urine specimens prior to surgery for evaluation of urinary levels of prostaglandin e_2 metabolite (pge-m). patients also undergo assessment of tissue obtained at the time of surgery, including ovarian tumor tissue, normal surface ovarian epithelium tissue (if available), and fixed tissue embedded in a paraffin block. tissue samples are analyzed by western blot and ihc for cyclooxygenase-1 and cyclooxygenase-2 expression.

Eligibility criteria:
inclusion criteria: * diagnosis of known or suspected ovarian cancer * age greater than 17 years exclusion criteria: * pregnant or nursing * taking steroids or non-steroidal anti-inflammatory drugs (nsaids) on a regular basis. prior concurrent therapy: * no concurrent chronic use of steroids or nsaids

Keywords: recurrent ovarian epithelial cancer stage i ovarian epithelial cancer stage ii ovarian epithelial cancer stage iii ovarian epithelial cancer stage iv ovarian epithelial cancer
the will erwin headache research center - cluster headache study

Conditions: Cluster Headache; Cluster Headaches and Other Trigeminal Autonomic Cephalgias; Paroxysmal Hemicrania; SUNCT; Hemicrania Continua; Trigeminal Neuralgia

Summary: the will erwin headache research center study of cluster headache and trigeminal neuralgia is a prospective, multicenter, observational research network for subjects with cluster headache and/or trigeminal neuralgia.

the will erwin headache research center will assemble a national registry of cluster headache patients and will sub-categorize and organize this cohort based on individuating characteristics including but not limited to type and severity of condition, associated symptoms, and medical/psychological issues (e.g., depression, disability, sleep). detailed evaluations and classification will be completed for each enrolled subject. this will encompass genomic and epigenomic studies, past medical history, imaging reports, and specific physical exam results for each patient. it will also enable the study investigators to match patients with suitable interventional clinical trials. similar diseases, such as other paroxysmal hemicrania, sunct, suna, hemicrania continua, and trigeminal neuralgia may also be investigated.

Eligibility criteria:
inclusion criteria: * diagnosis of a trigeminal autonomic cephalalgia according to the international headache classification including episodic cluster headache, chronic cluster headache, episodic paroxysmal hemicrania, chronic paroxysmal hemicrania, episodic short-lasting unilateral neuralgiform headache attacks with conjunctival injection and tearing (sunct), chronic sunct, episodic short-lasting unilateral neuralgiform headache attacks with cranial autonomic symptoms (suna), chronic suna, and hemicrania continua. or diagnosis of a trigeminal neuralgia according to the international headache classification, including classical trigeminal neuralgia and symptomatic trigeminal neuralgia. * able to provide hipaa authorization to share prior medical records/imaging. exclusion criteria: * life expectancy less than 1 year, co-existing disease or other characteristic that precludes appropriate diagnosis of a trigeminal autonomic cephalalgia or trigeminal neuralgia. * active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements * inability or unwillingness of subject or legal guardian/representative to give informed consent. inclusion criteria for healthy volunteers: * inclusion criteria is willingness to consent and be of age 18 and older
a study to evaluate the safety of thr-687 in subjects with diabetic macular edema (dme)

Conditions: Diabetes Mellitus; Diabetic Retinopathy; Diabetic Macular Edema

Summary: this study is conducted to evaluate the safety of a single intravitreal injection of thr-687.


Eligibility criteria:
inclusion criteria: * male or female aged 18 years or older * type 1 or type 2 diabetes mellitus * central-involved dme with central subfield thickness of ≥ 320µm on spectralis® spectral domain optical coherence tomography (sd-oct) or ≥ 305µm on non-spectralis sd-oct, in the study eye * best-corrected visual acuity (bcva) ≤ 62 and ≥ 23 etdrs letter score in the study eye * written informed consent obtained from the subject prior to screening procedures exclusion criteria: * macular edema due to causes other than dme * concurrent disease in the study eye, other than central-involved dme, that could compromise bcva, require medical or surgical intervention during the study period or could confound interpretation of the results * any condition that could confound the ability to detect a change in central subfield thickness in the study eye * previous confounding treatments / procedures, or expected to require confounding treatments / procedures at any time during the study period * presence of neovascularization at the disc (nvd) in the study eye * uncontrolled glaucoma in the study eye * any active ocular / intra-ocular infection or inflammation in either eye * poorly controlled diabetes mellitus * uncontrolled hypertension
dynamics of markers of infection and inflammation in hospitalized coronavirus disease 2019 (covid-19) patients

Conditions: COVID-19 Respiratory Infection

Summary: patients requiring admission to the hospital due to a moderate and severe covid-19 infection may differ in their ability to respond to viral infection and to eliminate viral load. several comorbidities and interventions like antivirotic or antiinflammatory treatment may also modify expected patients response and decrease of viral load. in this observational study, evolution of selected inflammatory markers, indicators of severity of infection and patient characteristics will be followed and recorded in hospitalized patients with covid-19.

in this pilot study, 30 consecutive covid-19 patients requiring admission to the hospital due to a moderate and severe covid-19 infection will be included into an observational study. following parameters will be recorded: age, sex, weight, height, comorbidities, smoking habit,spiritus and drug intake history, length of covid-19 symptoms, clinical and laboratory parameters, the use of different covid-19 intervention (remdesivir, convalescent plasma, monoclonal antibodies, corticosteroids, tocilizumab and other medication), used initial and maximal organ support during the stay and outcome of the stay in the hospital and 28th and 90th day, laboratory markers of severity of infection - serum and tracheal aspirate (in ventilated patients) levels of nucleocapsid antigen,severe acute respiratory syndrome coronavirus 2 (sars-cov2) viremia and quantity in tracheal aspirates (in ventilated patients), makers of inflammatory response (c- reactive proteins, interleukin 6, procalcitonin, ferritin) and selected other biochemical values (blood count, d-dimers, flow cytometry).

Eligibility criteria:
inclusion criteria: * sars cov2 positive test within last 14 day * bilateral infiltrates on chest x.ray or ct * need for oxygen to keep pulse oximetry saturation above 92% or other respiratory support measures (hfno, non-invasive ventilation or invasive ventilation) exclusion criteria: * known history of intersticial lung disease * known history of congestive heart failure

Keywords: covid19 interleukin 6 viremia nucleocapsid antigen
safety and efficacy study of dapsone gel in patients with acne vulgaris

Conditions: Acne Vulgaris

Summary: this study will assess the safety and efficacy of dapsone gel versus vehicle control in patients with acne vulgaris.

this is a multicenter, double-blind, randomized, parallel-group, vehicle-controlled study to assess the safety and efficacy of dapsone 7.5% gel versus vehicle administered topically once daily for 12 weeks in patients with acne vulgaris.

Eligibility criteria:
inclusion criteria: * diagnosis of acne vulgaris * willing to avoid excessive or prolonged exposure to ultraviolet light (eg, sunlight, tanning beds) throughout the study exclusion criteria: * severe cystic acne, acne conglobata, acne fulminans, or secondary acne * use of phototherapy devices (eg, clearlight™), energy-based devices, adhesive cleansing strips (eg, pond's®, biore®), or cosmetic procedures (eg, facials, peeling, comedo extraction) in the past week * use of anti-inflammatory medications, salicylic acid; corticosteroids, antibiotics, antibacterials (including benzoyl peroxide-containing products \[eg, benzamycin\]), retinoids; other topical acne treatments (eg, photodynamic therapy, medicated soaps such as those containing benzoyl peroxide, salicylic acid, sulfur, or sodium sulfacetamide) in the past 2 weeks * use of birth control pills strictly for acne control
a study of gzr18 injection in chinese adult patients with type 2 diabetes mellitus (t2dm)

Conditions: Type 2 Diabetes

Summary: this is a randomized, double-blind, placebo-controlled phase ib/iia clinical study in chinese patients with type 2 diabetes mellitus (t2dm) inadequately controlled with diet and exercise and/or treated with irregular use of antidiabetic drugs to evaluate the safety, tolerability, pharmacokinetics and efficacy of gzr18 injection in adult subjects with t2dm. this study is divided into part a and part b, which are to be conducted simultaneously.


Eligibility criteria:
inclusion criteria: 1. chinese adults, male and female, aged 18-65 years (both inclusive; subject to the date of signing of icf). 2. diagnosis of type 2 diabetes mellitus according to the diagnostic and classification criteria for diabetes mellitus issued by the world health organization (who) in 1999. 3. patients with type 2 diabetes mellitus (t2dm) inadequately controlled with diet and exercise and/or treated with irregular use of antidiabetic drugs. 4. hemoglobin a1c (hba1c) ≥ 7.0% and ≤ 10 % at screening; 5. body mass index (bmi) ≥ 18.5 kg/m2 and ≤ 35 kg/m2 at screening. 6. those who have no birth and sperm donation plans, and voluntarily take effective contraceptive measures from the signing of icf to 3 months after the last dose. a negative pregnancy test for women of childbearing potential at screening. 7. fully understanding the study objectives, the nature of the study, methods used and adverse reactions that may occur in the study, willing to enter the study and sign the icf, and capable of communicating well with the investigator, and understanding and abiding by the requirements of the study. exclusion criteria: 1. diabetes mellitus other than t2dm, such as type 1 diabetes mellitus. 2. fasting c-peptide \< 0.3 nmol/l. 3. use of any dpp-4 inhibitors, insulin secretagogues such as sulfonylureas, tzds and/or glp-1 analogs within 3 months prior to screening. 4. continuous insulin use for more than 14 days within 1 year prior to screening (time of insulin use for gestational diabetes mellitus is excluded from this limit). 5. treatment with growth hormone, diuretics, etc., that may affect insulin levels as judged by the investigator within 6 months prior to screening. 6. immunoserologic panel test results \[infection screening tests for hepatitis b surface antigen (hbsag), hepatitis c virus antibody (hcv-ab), human immunodeficiency virus antibody (hiv-ab), and treponema pallidum antibody\] assessed by the investigator as abnormal and clinically significant.