Kornimate/medical-research-clean huggingface dataset:
atrasentan spermatogenesis and testicular function

Conditions: Nephropathy; Diabetes

Summary: this study is being conducted to evaluate the effects of atrasentan on sperm production and testicular function in male subjects with type 1 or 2 diabetes and nephropathy. this study included 2 periods: a treatment period (up to 26 weeks) followed by an observational period (up to an additional 52 weeks).


Eligibility criteria:
inclusion criteria: * males 30 to 75 years of age * type 1 or 2 diabetes and receiving treatment with at least one anti-hyperglycemic medication and angiotensin-converting enzyme inhibitors (acei)/angiotensin receptor blockers (arb) (renin-angiotensin system \[ras\] inhibitor) * estimated glomerular filtration rate (egfr) equal to or greater than 35 ml/min/1.73 m\^2 with the chronic kidney disease epidemiology collaboration (ckd-epi) formula and urine albumin-to-creatinine ratio (uacr) equal to or greater than 30 and less than 5,000 mg/g creatinine. * able to provide a semen specimen at the required intervals. * baseline sperm concentration equal to or greater than 30 million per ml. exclusion criteria: * treatment with hormone suppressive agents or cancer chemotherapy within the 6 months prior to the initial screening visit or planned during the study. * history of severe peripheral edema or facial edema unrelated to trauma or history of myxedema in the prior 4 weeks prior to screening. * history of pulmonary hypertension, pulmonary fibrosis or any lung disease requiring oxygen therapy. * documented diagnosis of heart failure, previous hospitalization for heart failure or current or constellation of symptoms (dyspnea on exertion, pedal edema, orthopnea, paroxysmal nocturnal dyspnea) felt to be compatible with heart failure, that was not explained by other causes, and for which there was a change in medication or other management directed at heart failure. * currently receiving or has received hormone replacement therapy within 6 months prior to screening.

Keywords: diabetic nephropathies kidney diseases urologic diseases diabetes complications diabetes mellitus endocrine system diseases
the safety and efficacy of multiple-dose of js002 in subject with hyperlipidemia

Conditions: Hyperlipemia

Summary: js002 is a recombinant humanized anti-pcsk9 monoclonal antibody. this is a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy, as well as immunogenicity of js002 treated repeatedly in patients with hyperlipidemia when combined with statin therapy. in this study, two dose group (150 mg, 300 mg) were set up in this study. 750 subjects are plan to be enrolled (the study drug will be assigned to a 2:1 ratio of js002 or placebo). each subject required a maximum of 6 weeks of screening, 52 weeks of treatment, and 8 weeks of follow-up.


Eligibility criteria:
a limited list of criteria for selection of participants in the clinical study, provided in terms of inclusion and exclusion criteria and suitable for assisting potential participants in identifying clinical studies of interest. use a bulleted list for each criterion below the headers "inclusion criteria" and "exclusion criteria". (limit: 15,000 characters.) inclusion criteria 1. males and females ≥ 18 and ≤ 80 years of age; 2. ldl_c during screening period met the following conditions: super high risk: ldl - c ≥1.4mmol/l (55 mg/dl); extremely high risk: ldl - c ≥1.8 mmol/l (70 mg/dl); risk: ldl - c ≥2.6 mmol/l (100 mg/dl); low risk: ldl - c ≥ 3.4 /mmol/l (130 mg/dl) 3. fasting triglycerides ≤4.5 mmol/l; exclusion criteria 1. known hofh; 2. history of nyha class iii-iv heart failure; 3. history of uncontrolled arrhythmia, unstable angina,mi, pci,cabg, dvt or pulmonary embolism within 3 months. 4. uncontrolled hypertension. 5. uncontrolled diabetes mellitius (hba1c\>8.0%）. 6. other conditions that investigators considered inappropriate to participate in the study.
trial to evaluate the safety and effectiveness of vagus nerve stimulation for children with refractory epilepsy

Conditions: Refractory Epilepsy

Summary: children with refractory epilepsy who are candidates for a treatment with vagus nerve stimulation will be prospectively randomized into 2 arms. vagus nerve stimulation parameters are programmed and adjusted during outpatient clinic visits, within the normal clinical practice.


Eligibility criteria:
inclusion criteria: 1. age 3-6 2. at least 6 seizure per month 3. refractory epilepsy 4. in good health except epilepsy 5. patients or his(her) familyscould understand this method and sign the informed consent 6. patients with good compliance and could complete postoperative follow-up exclusion criteria: 1. results of mri remind epilepsy caused by intracranial space-occupying lesions 2. the vagus nerve lesion and damage 3. tumor, cardiopulmonary anomaly, progressive neurological diseases, asthma，mental disease，pepticulcer，diabetes，bad health etc, and other surgical contraindication 4. cann't write the epilepsy diary 5. participating other clinical trial 6. cann't complate the operation 7. complete the postoperative follow-up 8. cann't complete the promgramming
bibw 2992 and letrozole in hormonoresistant metastatic breast cancer

Conditions: Breast Neoplasms

Summary: progression-free rate after 16 weeks of bibw 2992 administration in association with letrozole


Eligibility criteria:
inclusion criteria: * female patients with histologically proven breast adenocarcinoma * presence of metastatic disease no more than 2 prior chemotherapy regimens for metastatic disease, which could include trastuzumab patients must currently be on letrozole and developed acquired resistance as defined by disease progression on letrozole following previous response (partial response or better, stable disease superior or equal to 24 weeks) diagnosis of disease progression inferior or equal to 6 weeks prior to trial entrydefined as: 1. increase in the number of bone lesions on bone scan or on mri and/or 2. increased pain in an area of known bony metastasis and superior or equal to 2 serial elevations in ca 15.3 and/or 3. progression according to recist criteria on ct scan, mri, or x-ray patients must have documented menopause confirmed by estradiol level inferior to 11 pg/ml exclusion criteria: * premenopausal patients * rapidly progressive disease in major organs (i.e. lymphangitic spread in the lung and/or bulky liver metastasis) patient with brain metastasis significant cardiovascular diseases previous treatment with an egfr and/or her-2 inhibiting drug(patients who received trastuzumab with chemotherapy but not with letrozole can be enrolled)
dexamethasone, azacytidine,pegaspargase and tislelizumab for nk/t cell lymphoma

Conditions: NK/T Cell Lymphoma

Summary: the optimal first-line treatment for extra-nodal nk/t-cell lymphoma (enktl) has not been well-defined. this phase ii study aimed to evaluate the efficacy and safety of dexamethasone, azacytidine, pegaspargase, tislelizumab (dapt) regimen for patients with newly diagnosed advanced stage enktl , non-upper aerodigestive tract nk/t- cell lymphoma（nuat- nktcl）and relapsed refractory nk/t cell lymphoma.


Eligibility criteria:
inclusion criteria: * age 18-70 years ,eastern cooperative oncology group (ecog) performance status of 0-2 * patients with confirmed pathological diagnosis of enktl as defined by who criteria * at least one measurable lesion * hemoglobin ≥90 g/l, absolute neutrophil count ≥ 1.5 × 10\^9/l, platelets ≥ 75 ×10\^9/l), alt≤ 2 times upper limit of normal, serum creatinine ≤1.5 times upper limit of normal （if the above indicators are abnormal but are caused by the primary disease as assessed by the clinician, the treatment can be enrolled according to the clinical actual situation） * there was no other serious disease in conflict with this program * adequate respiratory function * adequate bone marrow function * adequate renal and hepatic function * not pregnant or nursing ,negative pregnancy test * no other active malignancy requiring therapy * no other serious or life-threatening condition deemed unacceptable by the principal investigator * life expectancy ≥ 3 months * able to understand and sign an informed consent form (icf). exclusion criteria: * nk/t cell lymphoma without confirmed pathological diagnosis; * patients with early stage upper aerodigestive tract nk/t- cell lymphoma ; * patients with drug allergies or metabolic disorders in the program; * any uncontrolled medical diseases (including uncontrolled diabetes, severe heart, lung, liver and kidney dysfunction); * severe infection (excluding the following: hbsag or anti-hbc positive patients taking entecavir, tenofovir and other drugs;hcv rna positive but taking direct anti-hcv drugs); * invasion of primary or secondary central nervous system tumor invasion; * contradictions to chemotherapy or radiotherapy; * previously other malignancy requiring therapy; * peripheral nervous system disorder or mental disorder; * incapacity for legal conduct, medical or ethical reasons that affect the continuation of the research; * other clinical investigators; * combination of anti-tumor drugs outside the research program; * participants evaluated inappropriate to participate in this study by principal investigator.

Keywords: dapt tislelizumab non- upper aerodigestive tract nk/t- cell lymphoma r/r nk/t- cell lymphoma
bone metastases registry for patients undergoing cryoablation with curative purpose

Conditions: Bone Metastases

Summary: borealis is a multicentre, prospective, observational cohort study designed to investigate the effectiveness, feasibility, safety and impact on pain and quality of life of curative-intent cryoablation for the treatment of bone metastases in patients with oligometastatic or bone oligo-progressive disease.


Eligibility criteria:
inclusion criteria: * bone metastases in patients with oligometastatic disease (\<5 bone/visceral metastases) or bone oligo-progressive disease (visceral or osseous multi-metastatic disease stable under systemic treatment except 1-3 progressing bone metastases) from solid tumours; * number of target lesions ≤ 3 * size of target lesion(s) \< 5 cm (largest diameter); * referral to local ablative treatment by multidisciplinary tumour board (mdtb); * treatment by percutaneous cryoablation with curative intent (i.e., complete tumour destruction) assessed as technically feasible by the ir in charge; * procedure performed with a cryoablation system from boston scientific. exclusion criteria: * \< 18 years old; * incapacity or refusal to give informed consent; * ongoing pregnancy; * health status not compatible with the minimum meaningful follow-up period (i.e., 12 months): * karnofsky performance scale \< 60%, or * bone metastases originating from rapidly evolving tumour histologies not allowing reasonable life expectancy of at least 12 months, or * life expectancy \< 12 months * infection of treatment site or systemic infection; * uncorrectable coagulopathy; * haematological disease (including multiple myeloma and plasmacytoma); * concomitant radiation therapy or radiation therapy within 12 weeks before the planned cryoablation procedure.

Keywords: cryoablation oligo-progressive disease bone metastases oligometastatic disease oligo-progressive disease
telomerase activator and retinal amyloid

Conditions: Alzheimer Disease

Summary: a method of detecting amyloid in the retina has been developed. a specially designed retinal camera will directly visualze and record retinal amyloid and via image processing will generate a number: the retinal amyloid index (rai). the amount of retinal amyloid correlates with cerebral amyloid and has a predictive value in alzheimer's disease. telomere attrition accounts for cellular aging and is felt to have a pivotal role in alzheimer's disease. the investigators plan to screen individuals to select those having retinal amyloid then evaluate an oral telomerase activator to determine if its use can alter the rai over time compared to placebo.

telomerase activation - retinal amyloid study telomere attrition has been linked to the neurodegenerative disease alzheimer's disease (ad). ad is definitively diagnosed at autopsy a fact that has prompted exhaustive investigations looking for reliable biomarkers of ad. it is known that the clinical signs of ad are the end result of years of accumulation of an aggregated protein substance, amyloid. the retina is part of the brain and recently, a diagnostic technology has been developed that allows detection of retinal amyloid. tissue studies show a correlation between retinal and cerebral amyloid, and it has been proposed that early detection of retinal amyloid, long before clinical dementia, may offer an opportunity for intervention to slow or halt progressive amyloid deposition. special imaging technology has been developed that is capable of detecting retinal amyloid via an adapted retinal camera. neurovision imaging (nvi) is the company that has developed these testing technologies: both for retinal amyloid detection and measurement. a study is proposed that will investigate if there is a measurable treatment effect of the telomerase activator ta-65 on retinal amyloid of the participants. it is anticipated that recruiting will primarily be directed at adult children of individuals with clinical ad. the study will include 50 participants and will have a term of 12 months; it is anticipated that up to 300 individuals will be screened to acquire the participants. the study will be conducted at a single site: chippewa valley eye clinic, eau claire, wisconsin and/or its satellites. ta-sciences will sponsor the study, provide telomere length testing on saliva samples collected at the start and conclusion of study. ta-sciences will also provide active and placebo product for term of study.

Eligibility criteria:
inclusion criteria: * qualifying retinal amyloid index (rai) number as determined at screening * must be able to swallow capsule exclusion criteria: * cancer treatment within 5 years (except non-melanoma skin cancer) * must be able to swallow capsule

Keywords: retinal amyloid retinal amyloid index alzheimer disease telomere attrition telomere activation
in field performance of a hearing aid transducer

Conditions: Hearing Loss

Summary: study participants will be fit with previously released receiver-in-canal (ric) hearing instruments. participants will be asked to wear the instruments in their daily life for a minimum of 3 months, but have the option to continue to wear devices for six months.


Eligibility criteria:
inclusion criteria: * mild to moderate sensorineural hearing loss * adult exclusion criteria: * inability or unwillingness to wear study devices for extended period of time.
a study of mapatumumab in combination with sorafenib in subjects with advanced hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: the purpose of this study is to evaluate the safety and tolerability of escalating doses of mapatumumab in combination with sorafenib in subjects with advanced hepatocellular carcinoma who are positive for hepatitis b surface antigen or hepatitis c antibody.


Eligibility criteria:
inclusion criteria: * moderate liver disease * test positive for hepatitis b surface antigen or hepatitis c antibody * locally advanced unresectable/untransplantable or metastatic hepatocellular carcinoma * age 18 years or older exclusion criteria: * received investigational (not yet approved by a regulatory authority) or non-investigational agent to treat hepatocellular carcinoma. * received radiation therapy within 4 weeks before randomization * major surgery within 4 weeks before randomization * minor surgery within 2 weeks before randomization * systemic steroids within 1 week before randomization * hepatic encephalopathy, per the investigator's evaluation * history of clinically significant gastrointestinal bleeding requiring procedural intervention within 4 weeks before enrollment * history of any infection requiring hospitalization or antibiotics within 2 weeks before randomization * known brain or spinal cord metastases * history of other cancers within 5 years before enrollment * pregnant or breast-feeding women * known hiv infection

Keywords: liver cancer
pet in breast cancer receiving neoadjuvant chemotherapy

Conditions: Breast Cancer

Summary: prognostic factors in locally advanced breast cancer treated with neoadjuvant chemotherapy differ from those of early breast cancer. the purpose of this study was to identify the clinical significance of potential predictive and prognostic factors including serial fdg pet/ct in breast cancer patients treated by neoadjuvant chemotherapy.


Eligibility criteria:
inclusion criteria: 1. pathologically-confirmed breast cancer by core needle biopsy, 2. initial clinical stage ii or iii, 3. objective measurable lesion, 4. ecog performance 0\~2, 5. previously untreated, 6. adequate bone marrow, hepatic, cardiac, and renal functions 7. age 20\~70 8. agreement with this trial, and written informed consent exclusion criteria: 1. history of other cancer 2. active infection 3. pregnancy 4. psychologic disease 5. uncontrolled heart diseases 6. male

Keywords: breast cancer neoadjuvant chemotherapy molecular marker fdg pet locally advanced breast cancer
kangaroo care and premature infant sleep

Conditions: Premature Birth of Newborn

Summary: 90 preterm infants were randomly assigned to kangaroo care (skin-to-=skin, chest-to-chest) group (n=50) or control (remained in incubator, prone (n=40) for a pretest period of 2- 3 hours, then fed, then kc group was placed in kc and control group remained in incubator for a 2-3 hr test period. eeg measures of sleep, hr, and rr were taken. .

the neonatal intensive care unit (nicu) environment is not conducive to sleep, and infant sleep in incubators is fragmented. sleep contributes to brain maturation so interventions to foster sleep are needed. during kangaroo care (kc) behavioral indicators of quiet sleep have been observed but, not confirmed by objective electroencephalographic (eeg) analysis.the purpose was to determine the effects of kangaroo care (kc) on eeg-based sleep using nihon koden polysomnography and cardiorespiratory patterns by comparing kc sleep to incubator sleep.. a randomized controlled study with 90 preterms (kc = 50; control = 40) in which kc infants received 2-3 hours of kc between feeds after a comparable pretest period in an incubator and control infants remained in an incubator during the 2-3 hour pretest and test periods. in the incubator infants were inclined, prone, and nested; in kc infants were inclined, prone, and chest-to-chest underneath a blanket. the medically stable preterm infants were a mean 32 weeks postmenstrual age.

Eligibility criteria:
inclusion criteria: * subjects whose five-minute apgars were greater than 6, gestational age was 28 or more weeks at birth, and whose testing weight was greater than 1000 grams were included. exclusion criteria: * infants with encephalopathy, intraventricular hemorrhage greater than grade ii, white matter lucencies on cranial ultrasound, seizures, meningitis, or congenital brain malformations were excluded

Keywords: kangaroo care sleep heart rate respiratory rate preterm infant
effectiveness of relaxation technique for behavioral management of adhd children during dental treatment.

Conditions: Attention Deficit Disorder With Hyperactivity

Summary: evaluation of effect of relaxation technique (muscle relaxation) on behavioral management and anxiety control of adhd children during dental treatment.

evaluation of effect of relaxation technique (muscle relaxation) on behavioral management and anxiety control of adhd children during dental treatment compared to tell show do technique (control group) using modified frankl scale.

Eligibility criteria:
inclusion criteria: * children: 6 to 9 years old adhd children * teeth: teeth requiring dental treatment or preventive measure. exclusion criteria: * non adhd children. * adhd children having allergy to local anaesthesia or systemic problem that contraindicate dental treatment. * refusal of participation

Keywords: adhd behavioral management dental management
study of ux003 recombinant human beta-glucuronidase (rhgus) enzyme replacement treatment in mucopolysaccharidosis type 7, sly syndrome (mps 7) patients less than 5 years of age

Conditions: Sly Syndrome; MPS VII; Mucopolysaccharidosis; Mucopolysaccharidosis VII

Summary: the primary objective was to evaluate the effect of ux003 treatment in pediatric mps vii participants less than 5 years of age on safety, tolerability, and efficacy as determined by the reduction of urinary glycosaminoglycans (ugag) excretion.


Eligibility criteria:
inclusion criteria: 1. confirmed diagnosis of mps 7 based on leukocyte or fibroblast glucuronidase enzyme assay, or genetic testing. 2. under 5 years of age at the time of informed consent. 3. written informed consent of legally authorized representative after the nature of the study has been explained, and prior to any research-related procedures. exclusion criteria: 1. undergone a successful bone marrow or stem cell transplant or has evidence of any degree of detectable chimaerism with donor cells. 2. any known hypersensitivity to rhgus or its excipients that, in the judgment of the investigator, places the subject at increased risk for adverse effects. 3. use of any investigational product (drug or device or combination) other than ux003 within 30 days prior to screening, or requirement for any investigational agent prior to completion of all scheduled study assessments at any time during the study. 4. has a condition of such severity and acuity, in the opinion of the investigator, which may not allow safe study participation. for patients with hydrops fetalis, the ongoing interventions to manage fluid balance can be continued; if the addition of enzyme replacement therapy (ert) is considered a fluid-overload risk, the individual should be excluded. 5. has a concurrent disease or condition that, in the view of the investigator, places the subject at high risk of poor treatment compliance or of not completing the study, or would interfere with study participation or affect safety. since hydropic patients have a high rate of mortality, the risk of death prior to 1 year of age should not be considered sufficient to exclude the patient from the study for compliance.

Keywords: mps 7 sly syndrome mps vii enzyme replacement therapy rare disease mucopolysaccharidosis type 7 lysosomal storage disease metabolic disorder
pelvic osteotomy of the total hip replacement

Conditions: Congenital Hip Dysplasia; Hip Osteoarthritis

Summary: this observational study aims to learn about the outcomes in the previously operated patient and whether pelvic bone rearrangement surgery was a success. the main question it aims to answer is: • should the investigators perform pelvic rearrangement surgery on a patient if there's not enough bone stock to accomplish the exchange of the components? as the research started the participant was asked to attend outpatient clinics regularly and keep in touch. the investigators were able to observe the outcomes and closely explore probable risks for failure.

a 56-year-old female patient had a hip operation one year previously and experienced her first dislocation two months postoperatively. the patient underwent closed reduction three times. the patient presented to us due to a fourth hip dislocation that had occurred one month previously. hip x-ray images revealed acetabular component malposition, with an 80-degree inclination and 20 degrees of cup anteversion with a posterior hip dislocation. the investigators treated the patient via pelvic osteotomy, using a modified stoppa approach to reduce acetabular inclination. the patient had no dislocation at the 2-year follow-up. at the last follow-up, the harris hip score was 85.

Eligibility criteria:
inclusion criteria: * previously replaced total hip * minimum 1-year follow-up * 18-45 years, both sexes * otherwise healthy exclusion criteria: * any debilitating disorder * neurological or genetic disorders * pediatric or geriatric age

Keywords: revision hip arthroplasty