Kornimate/medical-research-clean huggingface dataset:
spectral domain oct imaging in patients with optic nerve head drusen (tuebingen sd-oct in optic nerve head drusen study)

Conditions: Optic Disc Drusen

Summary: optic nerve head drusen are a mostly bilateral change of the optic nerve, eventually causing a slow, but progression loss of the visual fields. characteristic are the crystalline deposits at the entrance of the optic nerve, the so called optic disc. the material consists of calcium, calcium phosphate, iron, but also amino acids and polysaccharides. the diagnose is made or confirmed by different imaging modalities like ultrasound and auto-fluorescence imaging. by using the high-resolution imaging with spectral-domain optical coherence imaging (sd-oct) the volume and deposits at the optic disc can be measured and quantified. the purpose of this study whether and how defects in the visual fields are related to the deposits. multimodal imaging of the optic nerve head is planned within the cross-sectional study, at two different time intervals (2 years). changes in retinal fibre layer (rnfl) thickness and disc parameters are analyzed. presence and extent of auto-fluorescent changes are evaluated. the prospective trial wants to clarify whether certain parameters at baseline indicate the further outcome and development.


Eligibility criteria:
inclusion criteria: * patients with drusen of the optic disc (as proven by ultrasound and clinical appearance) exclusion criteria: * mental disability * loss of fixation * other eye diseases potentially leading to a loss of visual fields

Keywords: drusen sd-oct
the changes in carotid plaque neovascularization after elovocumab therapy

Conditions: Carotid Artery Diseases

Summary: 150 selected patients will be recruited, who have at least one atherosclerotic plaque in the carotid artery that is thicker than 2.0 mm and which is determined to be uniformly or predominantly echolucent by standard ultrasonography. for each of the plaques, standard ultrasonography will be used to evaluate lesion echogenicity, while contrast-enhanced ultrasonography (ceus) will be used to perform the visual and quantitative analysis of neovascularization. each technique will be applied at baseline (at the time of study enrollment) and following 0.5、1 year of elococumab injection treatment. during the study, these patients will be treated with elococumab injection (1ml:140mg),ih, every two weeks.


Eligibility criteria:
inclusion criteria: * 1. have at least one atherosclerotic plaque in the carotid artery that is thicker than 2.0 mm and which is determined to be uniformly or predominantly echolucent by standard ultrasonography; * 2.patients were referred for optimal medical treatment; * 3.patients agreed to undergo follow-up ceus at half-year and 1-year interval. exclusion criteria: * 1.patients had previous history of cerebral thrombosis or cerebral embolism; * 2.patients were contraindicated to the usage of contrast media; * 3.image quality of baseline or follow-up ceus was severely impaired (in presence of severe artifact, non-diagnostic); * 4.patients withdrew the informed consents during follow-up; * 5.patients experienced major adverse cerebrovascular events during follow-up; * 6.patients refused to undergo follow-up ceus; * 7.lost follow-up
indications and evaluation of microfat grafting in cleft lip nasal deformities

Conditions: Cleft Lip and Nose

Summary: aim of the work: the study will be conducted to investigate the efficacy of microfat graftinig in cleft lip nasal deformities especially in young patients and those adults who don't need major correction after rhinoplasty.

microfat grafting was used for the first time in 1880, in reconstructive surgery to correct facial deformities, to reconstruct defects post oncological surgery, to treat complex wounds, and to manage scars. therefore its usage is increasing widely and particularly in maxillofacial and plastic surgeries. as lipofilling is a potential filler of reference for rhinoplasty and it can be performed on the dorsum, radix, glabella, pre-maxilla, and nasal pyramid. the investigators are suggesting it's use in cleft lip nasal deformities in some special situations. imperfections post rhinoplasty are common and there is an increased risk of patient dissatisfaction in revision surgeries. this may be due to a change in the nasal anatomy, the development of scar tissue, the loss of cartilaginous support, the altered blood supply, and the compromised soft tissue envelope. here comes the role of fat grafting which is a relatively simple and safe procedure to camouflage nose imperfections in filling the subcutaneous tissue, and in improving the skin quality post rhinoplasty. microfat grafting appears to be effective for correcting minor irregularities of nasal skin and may be appropriate for patients who cannot undergo revision rhinoplasty. it is also an effective salvage procedure for severely damaged skin of the nose. injection of cryopreserved fat over several sessions is well accepted by patients because cryopreservation of excess harvested fat grafts for subsequent use makes repeated fat graft harvesting unnecessary. microfat grafting is not a replacement for, but may be a complement to, modern rhinoplasty techniques.

Eligibility criteria:
inclusion criteria: 1. gender : both sex will be included in the study. 2. postcleft lip nose deformities. exclusion criteria: 1. refusing enrollment into the study. 2. refusing the surgery. 3. contraindication to anaesthesia.

Keywords: microfat grafting
interventions for patients with a shortened dental arch

Conditions: Anomaly of Dental Arch

Summary: dental services for large sectors of the population of the western cape (wc) province of south africa (sa) has been, and continues to be, limited to low-cost treatment options and emergency services, such as extractions at public health clinics. replacement of missing teeth for the disadvantaged majority of the population is provided almost exclusively at the dental teaching institutions. loss of teeth in the wc province is, as elsewhere, the result of disease and the lack of restorative care and then having these replaced by a removable partial denture, if the patient can afford it null hypothesis: the daily functional needs and quality of life of partially dentate adult patients with a reduced posterior dental arch and /or a shortened dental arch (sda) will not be satisfied nor improved by replacing the posterior teeth with a removable prosthesis.

the aim of this research is to determine whether the daily functional needs and the quality of life of partially dentate adult patients with a reduced posterior dental arch will be satisfied and improved without having the posterior teeth replaced with a removable prosthesis, as compared to having the use of such prosthesis. objectives: to conduct a randomized controlled trial amongst partially dentate adult patients with a reduced posterior dental arch (3-5 pairs of posterior occluding pairs of teeth) and where these patients will be randomly assigned to one of two groups: one group would be provided with a metal- based removable partial denture (rpdp) to replace the posterior teeth, the other will receive no treatment. daily functioning ability and patient satisfaction between the groups (with/without rpdp) would then be compared.

Eligibility criteria:
inclusion criteria: * patients with classic sda * patients with a reduced posterior dental arch (from 3-5 posterior occluding teeth) * specific age limits * remaining teeth periodontally sound * lost molars in one jaw * both canines and one premolar should be present exclusion criteria: * exclude patients with angle class 2 or 3 * signs of temporo-mandibular disorders * compliance is a problem (alcoholism/ drug addiction) * risk of over-eruption of teeth * patients wanting removable partial dentures

Keywords: randomized controlled trial intervention posterior reduced dental arch patient satisfaction sequential sampling
unraveling the klinefelter's disease physiopathology

Conditions: Klinefelter Syndrome; Infertility, Male

Summary: organoid model to unravel klinefelter syndrome infertility klinefelter syndrome (ks) is characterized by the presence of an extra chromosome x in male (47,xxy), it is the most frequent genetic cause of azoospermia in adult men. the investigators will isolate and expand spermatogonial cells from ks patients, then using an organoid model investigators will compare the behavior of these spermatogonia from ks patients when interacting with four combinations of somatic cell types incorporated in the extra cellular matrix hydrogel.

men with klinefelter syndrome candidate for tese or microtese (testicular sperm extraction) for azoospermia. one extra testicular biopsy (1-2 mm) will be cryopreserved and used later for the cells isolation and culture.

Eligibility criteria:
inclusion criteria: * klinefelter exclusion criteria: * mosaicism

Keywords: klinefelter syndrome fertility preservation, male
efficacy and safety study of two dose levels of azd2115 in subjects with moderate to severe copd

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: this is a phase iia dose-ranging, randomized, double-blind, chronic-dosing (14 days), three-period, placebo-controlled, multi-center, cross-over study to assess the efficacy and safety of two dose levels of a dual pharmacology molecule with the combined properties of a long-acting muscarinic antagonist (lama) and a long-acting beta-agonist (laba); (azd2115) delivered by a metered-dose inhaler (mdi) in subjects with moderate to severe chronic obstructive pulmonary disease (copd).


Eligibility criteria:
inclusion criteria: * chronic obstructive pulmonary disease diagnosis: subjects with an established clinical history of copd for more than 1 year at screening, according to the copd gold guidelines. * current or former smokers with a history of ≥10 pack years of cigarette smoking. * post-bronchodilator fev1/fvc ratio of \<70%. * pre-bronchodilator fev1 must be \<80% predicted * women of non-child bearing potential (ie., physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal); or women of child bearing potential, has a negative serum pregnancy test at screening and agrees to acceptable contraceptive methods for the duration of the study. exclusion criteria: * pregnancy: women who are pregnant or lactating. * significant diseases other than copd, ie., disease or condition which, in the opinion of the investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study. * primary diagnosis of asthma. * alpha-1 antitrypsin deficiency as the cause of copd * other active pulmonary disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, idiopathic interstitial pulmonary fibrosis, primary pulmonary hypertension, or uncontrolled sleep apnea. * poorly controlled copd (hospitalization due to poorly controlled copd within 3 months of screening or requiring treatment with corticosteroids or antibiotics in the 6 week interval prior to screening or during screening. * unstable ischemic heart disease, left ventricular failure, or documented myocardial infarction within 12 months of randomization. * clinically significant abnormal ecg.
red yeast rice for primary prevention of hypercholesterolemia

Conditions: Hypercholesterolemia

Summary: this two-year observational study will be conducted at the outpatient clinic of the department of traditional chinese medicine of taoyuan chang gung hospital from february 26, 2024 to december 31, 2025. this study will enroll 35\~55 year-old male patients who are expected to take lipocol forte capsules for primary prevention of hypercholesterolemia. the investigators will collect the tcm constitution questionnaires from patients before taking lipocol forte capsules and every three months after taking the medicine. at the same time, blood will be drawn to detect glycated hemoglobin, fasting blood sugar, insulin, lipids profile, liver and kidney function, creatine kinase, predictive parameters of atherosclerotic cardiovascular disease, and plasma bile acids, etc. fecal samples will also be collected to analyze the intestinal microbiota and fecal bile acid composition. this study will evaluate the efficacy, durability and safety of lipocol forte capsules in the primary prevention of hypercholesterolemia in patients with different constitutions, as well as whether it can reduce the risk of cardiovascular disease, and its influence on bile acid metabolism and intestinal microbiota.


Eligibility criteria:
inclusion criteria: * aged 35\~55 years old, ldl-c≥130mg/dl or patients with diabetes or chronic kidney disease with ldl-c ≥ 100mg/dl, expected to receive lipocol forte capsule 600mg bid exclusion criteria: 1. have received anti-hyperlipidemic drugs or red yeast rice treatment within the past month; 2. female; 3. have experienced rhabdomyolysis or abnormal liver function alt \>72 u/l due to taking red yeast rice; 4. bleeding diseases, such as abnormal platelets, abnormal coagulation factors, or gastrointestinal tract infection within one month 5. liver insufficiency alt \>72 u/l or renal insufficiency egfr \< 30 ml/min/1.73 m2; 6. have ever had coronary heart disease, myocardial infarction or cerebrovascular disease; 7. stressful situations, including hospitalization or surgery within the past or next month, and cancer still being treated; 8. uncontrolled hypertension (blood pressure ≥160/100 mmhg); 9. use antibiotics, probiotics or weight-loss drugs for more than 3 consecutive days within 3 months before inclusion in the study; 10. drug abuse or poor compliance; 11. use of traditional chinese medicine in the past month
a study to determine the variability of a 6-minute walk test in cystic fibrosis subjects with advanced lung disease

Conditions: Cystic Fibrosis

Summary: this is an observational study to be conducted at approximately 25 sites in the united states. approximately 25 subjects with severe obstructive cf lung disease (fvc \<40% predicted) will be enrolled.


Eligibility criteria:
inclusion criteria: * able to provide written informed consent * males or females who will be \>=14 years old at visit 3 * a proven diagnosis of cf as evidenced by a positive sweat test (sweat sodium or chloride \>60 meq/l by quantitative pilocarpine iontophoresis), or genotype and clinical symptoms consistent with the diagnosis of cf * able to perform reproducible spirometry maneuvers at visit 1 in accordance with the american thoracic society (coefficient of variation for three fev1 maneuvers \<=0.2) * fvc \<40% predicted for height, age and sex at visit 1 * on a stable regimen of chest physiotherapy (cpt) begun at least 7 days prior to visit 1 * able to complete the 6-minute walk test at visit 1 exclusion criteria: * use of an investigational drug or device within 28 days prior to visit 1 * experiencing an episode of severe acute respiratory failure, as determined by the investigator

Keywords: pulmozyme
real-world patient-reported outcome of sacituzumab govitecan in chinese metastatic triple-negative breast cancer

Conditions: TNBC - Triple-Negative Breast Cancer

Summary: the aim of this trial is to explore the real-world patient-reported health-related quality of life (hrqol), functioning, symptoms and symptom tolerability of sacituzumab govitecan or chemotherapy of the physician's choice for chinese mtnbc patients. evaluation of hrqol and functioning using the eortc qlq-c30 and qlq-br45 questionnaires, including change from baseline and time to deterioration in each scale or item. treatment-related symptoms and tolerability were assessed using the patient-reported outcomes of the pro-ctcae and pgi-tt questionnaires.


Eligibility criteria:
inclusion criteria: 1. patients aged over 18 years old. 2. patients have been diagnosed with metastatic triple-negative breast cancer (mtnbc). er, pgr, and her2 status were determined locally by immunohistochemistry (ihc) of patients' primary or metastatic tumor sections. er-negative and pgr-negative status was defined as≤1% staining in the nuclei by ihc. her2-negative status was defined by ihc staining 0 to 1+ or fluorescence in situ hybridization ratio \<2.0 if ihc 2+ or ihc not performed. 3. the metastatic disease was confirmed by clinical, imaging, histological, or cytological measures, including unresectable locally advanced breast cancer, de novo stage iv breast cancer, and recurrent metastatic breast cancer. 4. patients who have received at least 1 prior regimen in the metastatic setting. 5. plan to receive or has received sacituzumab govitecan monotherapy or chemotherapy of the physician's choice. 6. available medical history. 7. all patients can provide an informed consent before enrolment and data collection. exclusion criteria: 1. if participating in any controlled clinical trial, the subject cannot take part in this study. 2. her2 overexpression or gene amplification, ie, immunohistochemistry (ihc) 3+ or fluorescence in situ hybridisation (fish)+, where appropriate. 3. pregnancy and lactation. 4. severe hepatic impairment.

Keywords: sacituzumab govitecan chemotherapy metastatic breast cancer tnbc
in vitro maturation (ivm) for polycystic ovary syndrome (pcos)

Conditions: Polycystic Ovarian Syndrome

Summary: this pilot study will be a prospective investigation to study the efficacy and safety of in-vitro maturation (ivm) for women with polycystic ovarian syndrome (pcos). there will be 10 subjects total in this study. there will be no blinding to treatment. in-vitro maturation will provide a viable, safe option for women with pcos attempting pregnancy through the use of assisted reproductive technology (art).


Eligibility criteria:
inclusion criteria 1. 10 women between the ages of 18-34 inclusive at time of signing informed consent form. 2. a diagnosis of pcos by their primary md 3. an antral follicular count (afc) of \> 12 on one ovary on at least one occasion 4. a day 3 fsh level of \<8 iu/ml 5. in good general health off of current medications which may confound response to study medications. 6. desire to seek pregnancy actively during the study period by ivf-icsi. 7. a normal uterine cavity must have been confirmed by either hydrosonogram or hysteroscopy within two years of entering the study. 8. male partner able to provide adequate semen sample by ejaculation (no tese) exclusion criteria 1. current pregnancy 2. patients with uncorrected thyroid disease (defined as tsh \ 5.5 miu/ml). a normal level within the last year is adequate for entry. 3. patients with poorly controlled diabetes (hgb a1c over 8.0 ng/dl). 4. patients enrolled simultaneously into other investigative studies that require medications, proscribe the study medications, limit intercourse, or otherwise prevent compliance with the protocol. 5. patients with significant anemia (hemoglobin \< 10 mg/dl). 6. patients enrolled simultaneously into other investigative studies that would interfere with this research study. 7. have any contraindications to using birth control pills (oral contraceptives) as determined by the attending physician (e.g. history of thromboembolism or estrogen-dependent malignancy, such as breast cancer, etc.) -

Keywords: pcos ivm polycystic ovarian syndrome in vitro maturation ivf
beta amyloid pet/ct in various aβ-related disease

Conditions: Amyloid; Beta-Amyloid; Neurodegenerative Diseases

Summary: to evaluate the potential usefulness of 18f-92/av45, 11c-pib positron emission tomography/computed tomography (pet/ct) for the diagnosis of primary and metastatic lesions in various tau-related disease patients.

subjects with various tau-related disease patients underwent 18f-92/av45, 11c-pib pet/ct either for an initial assessment or for recurrence detection. lesions uptake was quantified by the maximum standard uptake value (suvmax). the sensitivity, specificity, positive predictive value (ppv), negative predictive value (npv) and accuracy of 18f-92/av45, 11c-pib pet/ct were calculated.

Eligibility criteria:
inclusion criteria: - (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include mri, ct, tumor markers and pathology report); (iii) patients who had scheduled aβ pet/ct scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the clinical research ethics committee. exclusion criteria: - (i) patients with non-malignant lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Keywords: pet/ct mri beta-amyloid
efficacy and safety of idp-121 and idp-121 vehicle lotion in the treatment of acne vulgaris

Conditions: Acne

Summary: the objective of this study was to evaluate the efficacy, safety, and tolerability of a once daily topical application of idp-121 lotion compared with its vehicle (idp-121 vehicle lotion) in participants with moderate to severe acne vulgaris (acne) (that is, acne having an evaluator's global severity score \[egss\] of 3 \[moderate\] or 4 \[severe\]).


Eligibility criteria:
key inclusion criteria: * male or female at least 9 years of age and older. * written and verbal informed consent must be obtained. participants less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if participant reaches age of consent during the study they should be re-consented at the next study visit). * participant must have a score of 3 (moderate) or 4 (severe) on the egss assessment at the screening and baseline visit key exclusion criteria: * use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study. * any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gram-negative folliculitis. * any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive. * participants with a facial beard or mustache that could interfere with the study assessments.
effect of empagliflozin on body composition and ketones

Conditions: Diabetes Mellitus; Fat; Intolerance, Pancreas

Summary: the purpose of this study is to evaluate changes of body composition induced by sodium-glucose cotransporter-2 (sglt2) inhibitor and its metabolic consequence in korean type 2 diabetes (t2d).

sodium-glucose cotransporter-2 (sglt2) inhibitor increases urinary excretion of glucose, promoting glycemic control and weight loss. however, it is unclear whether weight loss is attributed to decrease in fat components and associated with favorable changes in metabolic profile. the purpose of this study is to evaluate changes of body composition induced by sglt2 inhibitor and its metabolic consequence in korean type 2 diabetes (t2d).

Eligibility criteria:
inclusion criteria: patients with type 2 diabetes age: 20-79 years bmi ≥ 20 kg/m2 egfr ≥ 45 exclusion criteria: patients with type 1 diabetes secondary diabetes due to cushing diseases, acromegaly insulin user bmi \< 20 kg/m2 egfr \< 45 malignancy

Keywords: sodium-glucose transporter 2 inhibitor