Kornimate/medical-research-clean huggingface dataset:
myheartbaby: an initial evaluation of the myheartbaby psychosocial telemedicine program

Conditions: Congenital Heart Disease

Summary: this study will conduct an initial clinical evaluation of this support program to examine its impact on reducing caregiver stress, increasing confidence in daily feeding, and improving weight-for-age growth percentiles in infants with congenital heart disease (chd).

caregivers of infants with chd are at high-risk of anxiety and distress due to the complex daily caregiving demands. previous research has demonstrated decreased parental stress and more optimal infant developmental outcomes with a psychosocial intervention delivered to caregivers of infants with chd prior to hospital discharge as well as reduced healthcare use in caregivers who received medical video-consultations during the interstage surgical palliation period. this study will implement a telemedicine intervention program (myheartbaby) to support caregivers remotely in the daily care and adjustment to having an infant with chronic medical needs. the program is delivered via video chat over the internet and caregivers will complete questionnaires about general family information, stress, and feeding their infant.

Eligibility criteria:
inclusion criteria: * caregiver's infant is less than 45 days of age at time of study enrollment. * caregiver of infant with high-risk, shunt dependent physiology (one or two-ventricle circulation) having just received neonatal surgery for chd. * english is a primary language for caregiver of infant. exclusion criteria: * caregiver's infant is greater than 45 days of age at time of study enrollment. * not a caregiver of infant with high-risk, shunt dependent physiology having just received neonatal surgery for chd. * english is not a primary language for caregiver of infant.

Keywords: chd congenital heart disease
changes in serum, follicular fluid srebp1c and lrg1 levels in pcos patients and correlation with insulin resistance

Conditions: PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

Summary: polycystic ovary syndrome (pcos) is a common reproductive endocrine and metabolic disease that affects 6-20% of women of childbearing age worldwide. due to changes in modern lifestyles such as low fiber, high fat diets, sedentary lifestyles, smoking, and alcohol consumption, the risk of developing this disease has increased. its clinical manifestations are heterogeneous, with typical clinical manifestations being oligomenorrhea or amenorrhea, infertility, hirsutism, and polycystic ovarian changes under ultrasound. women affected by pcos face significant reproductive challenges, seriously affecting their quality of life and increasing their psychological burden.lrg1 has various regulatory functions, including glucose and lipid metabolism, ir, angiogenesis, organ fibrosis, and inflammation. lrg1 can activate the transcription factor srebp1 and participate in liver lipid synthesis in obese mice. srebp1c is the active form of srebp1. research has shown that srebp1c can directly or indirectly participate in the development of ir. therefore, the investigators speculate that lrg1 may play a certain role in the progression of pcos through srebp1c.understanding the local changes or metabolic characteristics of follicular fluid in patients with pcos can help elucidate the pathogenesis of pcos. therefore, in this study,the investigators aim to detect changes in serum and follicular fluid lrg1, srebp1c, and related hormone levels, and explore their role in the pathogenesis of pcos from a systemic and ovarian perspective, providing new ideas for the prevention and treatment of pcos and ir.

1. the diagnostic criteria for all participants with polycystic ovary syndrome included in the study were based on the 2003 european society for human reproductive and embryonic medicine and american society for reproductive medicine (eshre/asrm) diagnostic criteria in rotterdam. 2. collect basic data of all participants. 3. after informed consent, all participants were evaluated for insulin sensitivity(the degree of insulin resistance), using the insulin resistance index of the steady-state model. all participants were conducted after signing an informed consent form. 4. after informed consent, all participants were given fasting venous blood samples in the morning for measuring blood sugar, blood lipids, insulin, c-peptide, glycosylated hemoglobin (hba1c), and a complete set of sex hormones. 5. after collecting follicular fluid from all participants, centrifuge at 1000xg for 20 minutes, filter and precipitate, and freeze in a refrigerator at -80 ° c for the determination of lrg1, srebp1c, and related hormone levels in follicular fluid. 6. use spss 22.0 statistical software for data analysis.

Eligibility criteria:
inclusion criteria: clinical diagnosis of polycystic ovary syndrome exclusion criteria: congenital adrenal cortical hyperplasia adrenocortical carcinoma cushing syndrome.

Keywords: pcos insulin resistance
a longitudinal multi-omic biomarker profiling study of patients with head & neck squamous cell carcinoma (hnscc)

Conditions: Head and Neck Squamous Cell Carcinoma

Summary: the study is a prospective, longitudinal, non-interventional, multicenter study of participants with hnscc who will have tissue and blood based molecular biomarker profiling during their standard of care treatment.


Eligibility criteria:
inclusion criteria: * ≥18 years of age * willing and able to provide informed consent * histologically- or cytologically-confirmed metastatic or unresectable, recurrent hnscc unsuitable for local therapies * intended for first line anti-pd1 or pdl1 monotherapy or combination therapy * must submit tumor tissue sample representative of current disease per laboratory manual exclusion criteria: * non-squamous histologies (eg, nasopharynx or salivary gland) * relapse or recurrence within 6 months of first line chemotherapy and / or chemoradiotherapy * tumors that are pd-l1 negative (cps \<1) * clinical evidence of an active second invasive malignancy within \<2 years of enrollment with the exception of stable prostate cancer on watchful waiting, in situ cervical cancer, in situ breast carcinoma or localized non-melanoma skin cancers * unable to comply with study procedures (i.e., not willing or able to have additional blood samples collected)

Keywords: oncology biomarkers genomic profiling hnscc cancer observational registry precision medicine ngs
retinal thickness analysis using optical coherence tomography

Conditions: Diabetic Retinopathy

Summary: the main objective of this study is to characterize and correlate diabetic macular edema (dme), i.e. increased retinal thickness, measured by optical coherence tomograph (oct), and retinal visual function. the secondary objectives of this study are the analysis and characterization of dme progression over time (between two visits), and the comparison of oct data obtained with different devices. the results of this study will be used exclusively for scientific purposes.


Eligibility criteria:
inclusion criteria: * diagnosis of dr * females or males * age over 18 years * signed informed consent form exclusion criteria: * cataract or other eye disease that may interfere with fundus examinations * vitreous syneresis or posterior vitreous detachment * dilatation of the pupil \< 5 mm
clinical characteristics and outcomes of patients with pulmonary hypertension associated right heart failure

Conditions: Right Heart Failure; Pulmonary Hypertension

Summary: the study aims to describe the clinical characteristics and clarify the predictors of the short- and long-term outcomes of rhf patients, further assist the diagnosis, risk stratification and treatment of rhf.

right heart failure(rhf) is a clinical syndrome with symptoms, signs, and evidence of right ventricular systolic and/or diastolic dysfunction. for many years, it was largely neglected in the consideration of left-sided heart failure, while it is now evident that rhf is not only common but its presence also strongly contributes to increased morbidity and mortality. the in-hospital mortality of rhf is 7%, and the 30-day readmission rate is 20%. therefore, diagnosis, potential treatment strategies, and prognosis improvement have become an unmet need in the field of cardiovascular disease. in clinical practice, accurate diagnosis of rhf is the key to timely initiation of treatment and improvement of prognosis. although current guidelines recommend clinical symptoms and signs combined with echocardiography, cardiac magnetic resonance, and other imaging means to evaluate right heart dysfunction for comprehensive diagnosis of right heart failure, the key diagnostic indicators included are inconsistent, the weight ratio of each indicator is different, the diagnostic threshold is not uniform, and the lack of comprehensive diagnostic model system brings great challenges to clinical practice. this study aims to integrate multiple clinical biomarkers, imaging, and hemodynamic data to describe the clinical characteristics, establish noninvasive easy-to-use diagnosis models for right heart failure, and explore the risk factors for short- and long-term poor prognosis in patients with rhf.

Eligibility criteria:
inclusion criteria: 1. aged ≥18 years at the time of consent 2. acceptation of right heart catheterization examination 3. able to perform the entire protocol exclusion criteria: 1. life expectancy of less than 1 year based on the investigator's clinical judgment 2. pregnant or nursing 3. malignancy 4. planned to undergo heart transplantation or device implantation 5. acute coronary syndrome, uncontrolled severe arrhythmia and shock.

Keywords: right heart failure prognosis right ventricular function pulmonary hypertension biomarkers diagnosis
human mesenchymal stem cells for bronchopulmonary dysplasia

Conditions: Bronchopulmonary Dysplasia

Summary: this study is an open-label, single-center, dose escalation study to evaluate of safety and efficacy of human umbilical cord -derived mesenchymal stem cells (huc-mscs) in premature infants for moderate and severe bronchopulmonary dysplasia（bpd）.

bpd is a chronic lung disease that occur in premature infants receiving prolonged oxygen pulmonary and ventilator therapy. it remains a main complication of extreme prematurity and currently lacks efficient treatment.the mortality rate of one year after birth is still high and the quality of life is not optimistic. huc-mscs are widely used in clinic due to their low immunogenicity and convenient to get.many animal study had shown that huc-mscs had therapeutic effects on a variety of animal models of lung disease.furthermore,there are a large number of clinical trials of mscs applied to various system diseases and the safety was verified.so,the main purpose of this study is to evaluate the safety and efficacy of huc-mscs in participants with moderate and severe bpd.

Eligibility criteria:
inclusion criteria: 1. the participants meet the diagnostic criteria for moderate and severe bpd established by the national institutes of child health and human development (nichd) workshop. 2. the participants have abnormal respiratory manifestations. 3. written consent form signed by a legal representative or a parent. exclusion criteria: 1. although mechanical ventilation or oxygen is required in participants, there are no signs of dyspnea or bpd-related changes in lung imaging, such as central apnea or diaphragm paralysis. 2. the participants who have complex congenital heart disease. 3. the participants who have severe pulmonary hypertension(cardiac ultrasound confirmed) at the time of assessment. 4. the participants who have severe respiratory tract malformation: pierre-robin syndrome, tracheobronchomalacia, vascular ring syndrome, congenital tracheal stenosis, tracheo-esophageal fistula, pulmonary emphysema, pulmonary sequestration, congenital pulmonary dysplasia, congenital pulmonary cyst, congenital spasm, etc. 5. the participants who have severe chromosome anomalies :edward syndrome, patau syndrome, down syndrome, etc) or severe congenital malformation (hydrocephalus, encephalocele, etc). 6. the participants who have severe congenital infection(herpes, toxoplasmosis, rubella, syphilis, aids, etc). 7. the participants who have severe sepsis or shock. 8. the participants who is going to have surgery 72 hours before/after this study drug administration. 9. the participants who have surfactant administration within 24 hours before this study drug administration. 10. the participants who have severe intracranial hemorrhage ≥ grade 3 or 4. 11. the participants who have active pulmonary hemorrhage or active air leak syndrome at the time of assessment. 12. the participants who have the history of other clinical studies as a participant. 13. the participants who is considered inappropriate by the investigators.

Keywords: bronchopulmonary dysplasia human umbilical cord -derived mesenchymal stem cells
phase 1, first-in-human, dose-finding and expansion study to evaluate xmab®808 in combination with pembrolizumab in advanced solid tumors

Conditions: Head and Neck Squamous Cell Carcinoma; Melanoma Excluding Uveal Melanoma; Non-small Cell Lung Cancer, Squamous or Non-squamous; Urothelial Carcinoma; Renal Cell Carcinoma, Clear Cell; Castration-resistant Prostate Cancer; Ovarian Cancer, Epithelial; TNBC - Triple-Negative Breast Cancer; Colorectal Cancer

Summary: the purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of intravenous (iv) administration of xmab808 in combination with pembrolizumab in subjects with selected advanced solid tumors and to identify the minimum safe and biologically effective/recommended dose (rd) and schedule for xmab808.

this is a phase 1, open-label, first-in-human (fih), multiple-dose, dose escalation study with cohort expansion at the rd, designed to evaluate the safety and tolerability of xmab808 in combination with pembrolizumab. this study will be conducted in 2 parts: part a (dose escalation) and part b (cohort expansion).

Eligibility criteria:
key inclusion criteria: * part a: histologically confirmed advanced/metastatic castration-resistant prostate adenocarcinoma, epithelial ovarian cancer, head and neck squamous cell carcinoma, non-small cell lung cancer, urothelial carcinoma, melanoma, renal cell carcinoma, triple-negative breast cancer, or colorectal cancer that has progressed on standard therapies * part b: histologically confirmed advanced/metastatic castration-resistant prostate cancer that is pd1-naïve; head and neck squamous cell carcinoma that is pd1-naïve or has progressed on prior pd1 therapy; or melanoma that is pd1-naïve or has progressed on prior pd1 therapy * measurable disease by recist 1.1; subjects with prostate cancer who have evaluable disease according to pcwg3 criteria may enroll * life expectancy \> 3 months * eastern cooperative oncology group (ecog) performance status of 0 or 1 key exclusion criteria: * subjects currently receiving other anticancer therapies * any prior treatment with an investigational agent targeting cd28 * history of a life-threatening adverse event related to prior immunotherapy * known active central nervous system involvement by malignant disease. subjects with previously treated brain metastases may participate provided they are radiologically and clinically stable
a study of loxo-260 in cancer patients with a change in a particular gene (ret) that has not responded to treatment

Conditions: Carcinoma, Non-Small-Cell Lung; Thyroid Neoplasms

Summary: the main purpose of this study is to learn more about the safety, side effects, and effectiveness of loxo-260. loxo-260 may be used to treat cancer that has a change in a particular gene (known as the ret gene). participation could last up to 24 months (2 years) and possibly longer if the disease does not get worse.


Eligibility criteria:
inclusion criteria: * must be ≥ 18 years of age at the time of signing the informed consent (phase 1a and phase 1b). patients 12 years and older may be enrolled in phase 1b for countries and sites where approved. * must have evidence of a previously documented ret fusion (solid tumors) or ret mutation (mtc or men2-associated cancers) that is a histological or a cytological proven diagnosis of locally advanced, unresectable and/or metastatic cancer and meet cohort-specific criteria. * have received a prior selective ret inhibitor. * eastern cooperative oncology group (ecog) score of 0 to 1 (age \> 16 years), karnofsky performance status (kps) ≥ 80 (age \> 16 years), or lansky performance status (lps) ≥ 40% (age \< 16 years). * have discontinued all previous treatments for cancer with resolution of any significant aes, and of all clinically significant toxic effects of prior locoregional therapy, surgery, radiotherapy, or systemic anticancer therapy. * have adequate organ function. * phase 1b expansion: patients must have measurable disease per recist v 1.1. * phase 1b expansion: molecular pathology results (including ret and other genes) from a sample, blood or tissue, taken on or after ret selective treatment. exclusion criteria: * disease suitable for local therapy administered with curative intent. * have an active fungal, bacterial, and/or active untreated viral infection. * the patient has a serious pre-existing medical condition(s). * have symptomatic cns malignancy or metastasis. * patients treated with drugs known to be strong inhibitors or inducers of cytochrome p450 3a (cyp3a). * progression of disease within 4 months of starting a prior selective ret inhibitor. * phase 1b expansion: patients harboring known activating bypass alterations outside ret that may confer resistance to loxo-260.

Keywords: solid tumors with ret alteration
a master protocol to evaluate dcc-3009 in gastrointestinal stromal tumor (gist)

Conditions: Gastrointestinal Stromal Tumor (GIST)

Summary: the purpose of this phase 1/2 master protocol study is to evaluate if dcc-3009 is safe, tolerable and works effectively in the treatment of gist. the study will use a modular approach with each module being defined according to therapy: dcc-3009 alone or dcc-3009 in combination with other anticancer therapies. each module will be conducted in 2 parts: part 1 (dose escalation) and part 2 (dose expansion). participants will be treated in 28-day treatment cycles with an estimated duration of up to 2 years.


Eligibility criteria:
inclusion criteria: module a part 1 (escalation): * any participant with histologically or cytologically confirmed advanced/unresectable or metastatic gist with documented kit or platelet-derived growth factor receptor alpha (pdgfra) mutation, who has progressed on or was intolerant to at least 1 approved tyrosine kinase inhibitor (tki) regimen in the advanced/metastatic setting * have at least 1 measurable lesion as defined by mrecist, v1.1 * have eastern cooperative oncology group (ecog) performance status (ps) of 0 or 1 * adequate organ function, bone marrow function, and electrolytes * all participants agree to comply with the contraception requirements * have a life expectancy of more than 3 months exclusion criteria: * received systemic anticancer therapy or radiotherapy within 14 days prior to first dose of study drug * prior or concurrent malignancy that requires treatment or is expected to require treatment for active cancer * has known active central nervous system (cns) metastases or an active primary cns cancer * history or presence of clinically relevant cardiovascular abnormalities * major surgery within 28 days of the first dose of study drug * had systemic arterial thrombotic or embolic events within 6 months prior to the first dose of study drug * had venous thrombotic events (e.g., deep vein thrombosis) or venous thrombotic embolic events (e.g., pulmonary embolism) within 1 month prior to the first dose of study drug * known allergy or hypersensitivity to any component of the study drug * malabsorption syndrome or other illness that could affect oral absorption * any other clinically significant comorbidities

Keywords: pdgfra mutations kit mutations
corticosteroid and ozone injection in patıents with carpal tunnel syndrome

Conditions: Carpal Tunnel Syndrome

Summary: there are a limited number of studies on the use of ozone in cts.the aim of this clinical study is to compare the effectiveness of corticosteroid injections and ozone injections added to splint and exercise therapy in mild-moderate cts patients.. 106 patients included in the study were randomized and divided into three groups. during the follow-up, a total of 90 patients, 30 patients in each group, completed the study.

106 patients included in the study were randomized and divided into three groups. during the follow-up, a total of 90 patients, 30 patients in each group, completed the study. neutral hand-wrist rest splint and tendon-nerve gliding exercises were given to 30 patients included in the control group. in addition to the treatment given to the first group, 40 mg (1 ml) triamcinolone acetonide was injected under usg guidance to 30 patients included in the corticosteroid group. in addition to splint and exercise therapy, 3 cc ozone (o2-o3), 10 micrograms were injected under usg guidance to 30 patients in the ozone group. patients in all three groups were evaluated at the beginning of treatment, 6 weeks and 3 months after treatment. evaluation methods include provocative tests (tinnel, phallen, flick tests), visual analogue scale (vas) numbness day/night and vas pain scores, sensory tests (two-point discrimination and semmes weinstein monofilament test (swmt)), hand and finger grip strengths. measurement, boston carpal tunnel syndrome questionnaire (bcta), median nerve cross-sectional area (msca) measurement with usg and electrophysiological parameters were used.

Eligibility criteria:
inclusion criteria: * between the ages of 18-70, male or female. * clinically and electrophysiologically diagnosed with mild or moderate cts * having symptoms for 1 month or longer * no contraindications for corticosteroid and ozone application * patients whose consent was obtained to participate in the study exclusion criteria: * under 18 years old and over 70 years old * having a severe cts * having thenar atrophy * those with diabetes, thyroid and kidney disease and cts developing secondary to this * those with previous traumatic nerve injury, peripheral nerve injury or surgery * those with a diagnosis of polyneuropathy * having rheumatic disease * with known radiculopathy * are pregnant * known g6pd deficiency, hyperthyroidism, thrombocytopenia, severe cardiovascular instability * those who have infection, burns, cuts or skin integrity in the skin area to be treated * cognitive disorder, severe psychiatric illness * those with diabetes, thyroid and kidney disease and cts developing secondary to this * patients who have not received corticosteroid or ozone injection in the last 3 months

Keywords: ozone injection corticosteroid injection carpal tunnel sendromu ultrasound guided injection