Kornimate/medical-research-clean huggingface dataset:
music therapy for the treatment of cisplatin induced tinnitus in patients with rgcc: a pilot study

Conditions: Relapsed Germ Cell Cancer; Cisplatin Induced Tinnitus

Summary: pilot study evaluating the feasibility of recruitment, retention, and compliance to a modified heidelberg model of neuro-music therapy (mhnmt) in patients with cisplatin-induced tinnitus and relapsed germ cell cancer (rgcc).

this is a prospective, interventional pilot study that plans to enroll 15 patients who are receiving salvage high dose chemo and bone marrow transplant for relapsed germ cell cancer (rgcc). patients will be asked to go through a series of surveys and screening procedures to determine eligibility. once enrolled, patients will receive music therapy while they are being treated either inpatient or outpatient for their standard of care treatments. primary objective to evaluate the feasibility of recruitment, retention, and compliance to a mhnmt in patients with cit and rgcc admitted to bmt service to undergo salvage high-dose chemotherapy with tandem bone marrow rescue. secondary objectives to estimate the effects of mhnmt on severity of cit, associated distress, anxiety, depression, fatigue, benefit findings, sleep, and audiometry measures and assess number of times homework completed.

Eligibility criteria:
inclusion criteria: 1. ≥ 18 years old at the time of informed consent. 2. english speaking. 3. ability to provide written informed consent and hipaa authorization 4. confirmed diagnosis of cit via a score on the tfi of 26 or greater. 5. personal history of rgcc. 6. previous exposure to cisplatin. 7. admitted to bmt service to undergo hdc-tbmr for the first time. (because this is a feasibility study, a minimum number of mt sessions will not be required). 8. agrees not to receive music therapy outside of study. exclusion criteria: 1. severe hearing impairment greater than 60 db hl in the region of the center tinnitus frequency 2. patient's tinnitus can not be pitch matched. 3. clinical diagnosis of severe mental disorder or psychiatric or neurological disease such as psychosis, epilepsy, parkinson's disease, dementia, alcohol or drug abuse.

Keywords: relapsed germ cell cancer cisplatin induced tinnitus music therapy germ cell cancer
ningbo schizophrenia cohort

Conditions: Schizophrenia

Summary: in recent years, the prevalence of schizophrenia in china has continued to grow, and the burden of disease in society has continued to rise. in order to improve the prognosis of patients with schizophrenia and reduce the risk of disease relapse or readmission, researchers established a cohort based on the ningbo mental health information system in ningbo, a sub-provincial city in the southern wing of the yangtze river delta of china, with a resident population of more than 9 million, and linked it to the residents' health records, and through the data linkage obtained data on patients in the full cycle of pre-onset, diagnosis, follow-up, disease changes and death, realising full-cycle management of patients with schizophrenia. currently, nsc has accumulated data on more than 30,000 patients with schizophrenia and obtained multi-dimensional longitudinal information through long-term follow-up and data linkage. all diseases follow the world health organization international classification of diseases 10th edition (icd-10) for clinical coding, and available data include baseline demographics, past history, family history, social functioning deficit screening scale scores, risk assessment, and so on and longitudinal health information from electronic health records (ehr), providing a solid data base for future real-world studies.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of schizophrenia (f20) * aged 18-65 years at the time of diagnosis exclusion criteria: * none.

Keywords: population-based healthcare database longitudinal study ambispective cohort schizophrenia
innoventric trillium™ stent graft early feasibility study (efs)

Conditions: Tricuspid Regurgitation; Tricuspid Regurgitation Functional

Summary: early feasibility study to evaluate the safety and performance of the innoventric trillium™ stent graft in the treatment of severe or greater tricuspid regurgitation (tr).

prospective, single arm, multi-center, early feasibility study (efs) to assess the safety and performance of the innoventric trillium™ stent graft in the treatment of severe or greater tricuspid regurgitation (tr). up to fifteen (15) patients at up to 10 us investigational sites and 3 german investigational sites will be enrolled. all enrolled study patients will be assessed at baseline, during the procedure, at discharge, and after 1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years following the index procedure.

Eligibility criteria:
inclusion criteria: * patient has clinically significant tr graded as severe or greater * peak central venous pressure of ≥ 15mmhg * patient has nyha functional classification of iii or iv * patient is not eligible for standard-of-care surgical or interventional therapy or has refused standard-of-care surgical and interventional therapy or has received standard-of-care tr therapy and remains symptomatic exclusion criteria: patients will be excluded from participation if any of the following criteria apply: * severe rv dysfunction defined by tapse, rvef, or rvfac. * anatomical suitability according to ct scan. * systolic pulmonary artery pressure \> 65mmhg * moderate or more mitral valve stenosis * greater than moderate mitral valve regurgitation or aortic valve stenosis/regurgitation * moderate mitral valve regurgitation combined with moderate aortic valve stenosis/regurgitation * kidney dysfunction with estimated glomerular filtration rate (egfr) \< 35 ml/min/1.73 m2 within 60 days prior to the index procedure or patient is on chronic dialysis * liver cirrhosis or moderate or severe liver disease (child-turcotte-pugh class b or c, or a score of 7 or higher) * thrombocytopenia (platelet count\ 750,000/mm3) within 14 days of the index procedure * in the opinion of the investigator or the study eligibility committee, the patient's life expectancy \< 12 months

Keywords: tricuspid valve transcatheter tricuspid regurgitation tricuspid valve insufficiency
a biospecimen collection study in braf-v600e mutated recurrent gliomas

Conditions: Glioma; BRAF V600E; Pleomorphic Xantho-Astrocytoma; Glioblastoma

Summary: this is a surgical biospecimen collection study. the purpose of this study is to understand how much of two drugs (dabrafenib and trametinib) are able to penetrate brain tumors and turn off the raf signaling pathway. this is important because these drugs are currently fda approved for other tumors and may have efficacy in brain tumors with the braf v600e mutation.

the primary goal of this study is to establish concentrations of dabrafenib and trametinib in enhancing brain tissue and cerebrospinal fluid from people with braf-v600e mutant recurrent gliomas who undergo tumor resection. the exploratory goals are to measure the amount of erk signaling pathway activity, to identify mechanisms of resistance to these drugs, and evaluate feasibility of measuring tumor dna in cerebrospinal fluid. people (adults or children) with brain tumors who are already taking dabrafenib and / or trametinib and are in need of a surgical resection are potentially eligible. on the day of surgery, blood, cerebrospinal fluid, and tumor tissue will be collected for research purposes.

Eligibility criteria:
inclusion criteria: * subjects must have a history of primary brain tumor (including but not limited to glioblastoma (gbm), anaplastic astrocytoma (aa), anaplastic ganglioglioma (ag), and anaplastic pleomorphic xanthoastrocytoma (pxa)). * subjects must have a braf-v600 mutation identified in previous tissue analysis (may be ihc or pcr based). allowable mutations include v600e, v600k, v600r, and v600d. * subjects must be taking dabrafenib at a dose of at least 50mg twice daily (adults only) and / or trametinib at a dose of at least 1mg daily (adults only) for at least 7 days prior to surgery as prescribed by their treating physician. note: pediatric patients may be taking any dose of dabrafenib and / or trametinib as prescribed by their treating physician for at least 7 days prior to surgery. * subjects must be undergoing surgery for clinical purposes. * written informed consent - a signed informed consent and/or assent (as age appropriate) for study participation will be obtained according to institutional guidelines. exclusion criteria: * subjects who are receiving any other investigational agents or chemotherapeutic agents. * subjects for whom collection of blood, spinal fluid, or tissue samples is unsafe or clinically inadvisable.
a study to compare ipx066 and carbidopa/levodopa/entacapone (cle) followed by an open-label safety study of ipx066

Conditions: Parkinson's Disease

Summary: this is a study to compare the efficacy of ipx066 and cle in subjects with advanced parkinson's disease.

this is a randomized, double-blind, double-dummy, 2 treatment, 2-period crossover study followed by an open-label extension study period.

Eligibility criteria:
inclusion criteria: 1. diagnosed with idiopathic parkinson's disease (pd). 2. at least 30 years old at the time of pd diagnosis. 3. currently being treated with carbidopa/levodopa/entacapone (cle) and on a stable regimen of conventional ld for at least 4 weeks and: * requiring a total daily levodopa (ld) dose of at least 400 mg * having a minimum dosing frequency of four times per day. * individual cd-ld or cle doses that contain an ld dose which is a multiple of 50 mg. 4. able to differentiate "on" state from "off" state. 5. have predictable "off" periods. 6. amantadine, anticholinergics, selective monoamine oxidase (mao) type b inhibitors (e.g., selegiline, rasagiline) or dopamine agonists are allowed as long as the doses and regimens have been stable for at least 4 weeks prior to screening and the therapy is intended to be constant throughout the course of the study. 7. agrees to use a medically acceptable method of contraception throughout the study and for 1 month afterward. exclusion criteria: 1. diagnosed with atypical parkinsonism or any known secondary parkinsonian syndrome. 2. nonresponsive to ld therapy. 3. prior functional neurosurgical treatment for pd (e.g., ablation or deep brain stimulation) or if such procedures are anticipated during study participation. 4. received within 4 weeks of screening or planning to take during participation in the clinical study: any controlled-release ld product, tolcapone, apomorphine, nonselective mao inhibitors, or antipsychotics including neuroleptic agents for the purpose of treating psychosis or bipolar disorder. 5. allergy or hypersensitivity to cd, ld, entacapone, riboflavin, yellow dye #5 (tartrazine), citrus fruit or grape juice. 6. history of or currently active psychosis. 7. active or prior medical conditions such as peptic ulcers or prior surgical (e.g., bowel) procedures that would interfere with ld absorption. 8. active or history of narrow-angle glaucoma. 9. history of malignant melanoma or a suspicious undiagnosed skin lesion. 10. history of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias, upper gastrointestinal hemorrhage, or neuroleptic malignant syndrome or nontraumatic rhabdomyolysis. 11. received any investigational medications during the 4 weeks prior to screening. 12. unable to swallow large pills (e.g., large vitamin pills). 13. pregnant or breastfeeding. 14. subjects who are unable to complete a symptom diary.
topical antiperspirant for hand-foot syndrome

Conditions: Palmar-plantar Erythrodysesthesia

Summary: the objectives of this study are to evaluate the effectiveness of an antiperspirant in preventing or attenuating the severity of palmer-plantar erythrodysesthesia associated with the food and drug administration (fda)-approved doses of capecitabine. the hypothesis is that cytotoxic compounds in sweat will be prevented from being deposited in the skin and causing chronic toxicity.


Eligibility criteria:
inclusion criteria: * has not previously received a regimen that includes 5-fluorouracil * \> 18 years old * no known allergy or intolerance to ban unscented roll-on antiperspirant exclusion criteria: * \< 18 years of age
dräger covid-19 antigen test clinical performance study

Conditions: Covid19

Summary: the study is designed to demonstrate suitability of the dräger antigen test for sars-cov-2 detection in clinical nasal specimens. real-time polymerase chain reaction (rt-pcr) on specimens collected by pharyngeal swabs serves as a reference method.

the dräger antigen test sars-cov-2 is a rapid lateral flow immunoassay for the qualitative detection of sars-cov-2 nucleoprotein directly from less invasive nasal swabs, to be performed at the point of care. the test kit contains all components required to carry out a test detecting sars-cov-2 nucleoprotein. the study is designed to demonstrate suitability of the dräger antigen test for sars-cov-2 detection in clinical nasal specimens. real-time polymerase chain reaction (rt-pcr) on specimens collected by pharyngeal swabs serves as a reference method. the goal of the study is to compare dräger test results to the corresponding pcr data for overall sensitivity and specificity. specimens are collected from patients showing covid-19 symptoms as well as asymptomatic participants. participants are recruited across all genders and eligible age groups. study staff records participants' information such as symptoms and time since symptom onset. for each study participant, the specimen for rt-pcr is collected first, then the dräger test specimen. the dräger test result is read after 15 min to 20 min.

Eligibility criteria:
inclusion criteria: * participants must require sars-cov-2 testing for the following reasons: * covid-19 symptoms (fever, cough and/or sore throat, fatigue/ general feeling of weakness, loss of sense of smell and/or taste, shortness of breath, muscle stiffness/ body aches, head cold/ running nose, etc.) on the day of testing, or * known or suspected exposure to sars-cov-2 (contact persons etc.), or * member of a group of high risk of exposure such as healthcare workers etc., or * require screening for any other reason, e.g. doctor's orders, hygiene directive etc. * participant must be of legal age and must be able to understand the procedure and letter of consent. exclusion criteria: * patients younger than 18 years old are excluded from the study. * pregnant or breastfeeding patients are excluded from the study. * patients unable to provide written informed consent are excluded. * patients with bleeding disorder are excluded from the study as a precaution. * hospitalized patients/inpatients are excluded. * application of nasal spray within 15 min prior to testing. * participants with symptoms on the day of testing are excluded, if any of their symptoms started more than 14 days prior to testing. * asymptomatic participants are excluded, if they experienced any symptoms in the 14 days prior to testing.

Keywords: antigen test
the effects of diesel exhaust inhalation on vascular function - the role of endothelin

Conditions: Coronary Disease

Summary: the purpose of this study is to identify the role of endothelin 1 (a natural vasoconstrictor) in the adverse vascular effects demonstrated after exposure to air pollution

air pollution is a major problem, and can be linked to around 5% of all deaths worldwide each year. there are strong associations between air pollution exposure and heart disease but we do not yet understand how these harmful effects are mediated. understanding this mechanism is likely to have a major impact on the way we treat patients with heart disease and have the potential to shape future environmental health policy. the upregulation of endothelin-1 provides a plausible mechanism for these harmful effects, and we plan to investigate this in more depth in the human forearm following exposure to diesel exhaust.

Eligibility criteria:
inclusion criteria: * healthy male volunteers exclusion criteria: * use of regular medication * cigarette smoking * significant occupational exposure to air pollution * intercurrent illness

Keywords: endothelin air pollution diesel exhaust vascular function exposure
treatment of cfs & fibromyalgia with recovery factors

Conditions: Fibromyalgia; Chronic Fatigue Syndrome

Summary: the study will explore if recovery factors improve symptoms in fibromyalgia and chronic fatigue syndrome

subjects will receive four tablets twice a day (three times a day for five day loading dose), taking the treatment for 5 - 6 weeks. subjects will receive four tablets twice a day (three times a day for five day loading dose), taking the treatment for 5 - 6 weeks. the treatment is a unique nutritional peptide mix derived from porcine serum

Eligibility criteria:
inclusion criteria: * meet acr 2010 amended fibromyalgia criteria or cdc cfs criteria overall well being score of 5 of less (on 0-10 vas) exclusion criteria: pregnant clotting disorders -
mobile after-care intervention to support post-hospital transition (macs)

Conditions: Psychotic Disorders

Summary: this study examines the feasibility and acceptability of a mobile device-delivered app, called mobile after-care support (macs), to improve patients' coping and treatment adherence following a hospitalization related to their psychotic-spectrum disorder.

in the open trial, all participants will receive a study-developed app to be used on a mobile phone. this app will support the use of healthy coping skills post-hospitalization, as well as help participants adhere to their discharge treatment plan. this phase is intended to inform the feasibility and acceptability of the app in preparation for a future randomized controlled trial.

Eligibility criteria:
inclusion criteria: 1. currently hospitalized 2. dsm-5 criteria for psychotic disorder (schizophrenia or schizoaffective disorder) 3. 18 years or older 4. prescribed oral antipsychotic medication upon discharge 5. ability to speak and read english exclusion criteria: 1. alcohol/drug use disorders at moderate or severe level 2. planned discharge to supervised living setting or participation in formal outpatient adherence programs (e.g., medication packaging) 3. pregnancy or other medical condition (e.g., dementia) contraindicating use of antipsychotic medications.

Keywords: medication adherence treatment adherence ecological momentary assessment ecological momentary intervention coping skills psychiatric hospitalization
national data bank for rheumatic disease registry study of safety in patients with rheumatoid arthritis treated with cimzia® or disease-modifying antirheumatic drugs (dmards)

Conditions: Rheumatoid Arthritis

Summary: observational registry to assess the longer-term risk of serious infections and malignancies reported with tnfα-blocker therapy, as well as the longer-term risk of cardiovascular and thromboembolic events in adult rheumatoid arthritis (ra) patients treated with cimzia® as compared to non-biologic dmard-treated controls.


Eligibility criteria:
inclusion criteria: * ra and started treatment with certolizumab pegol (cimzia®; czp) or non-biologic dmard within the last 6 months

Keywords: certolizumab pegol czp cimzia® ndb registry
ultrasound for socket healing evaluation

Conditions: Healing Wound; Alveolar; Wound; Alveolar Bone Loss; Image; Dent Disease

Summary: the design is a single blinded, dual comparative study of ultrasound versus micro-ct/lasca in one study group. up to a total of 140 subjects registered will be recruited. subjects who are treatment planned for extraction of a hopeless tooth and socket augmentation with bone graft and are planned for a dental implant surgery. the socket will be evaluated before the extraction and multi-time points during healing until an implant is placed with various evaluation tools, including ultrasound.

the design is a single blinded, dual comparative study of ultrasound versus micro-ct/lasca in one study group. up to a total of 140 subjects registered will be recruited. subjects who are treatment planned for extraction of a hopeless tooth and socket augmentation with bone graft and are planned for a dental implant surgery. qualified subjects will be asked during their pre-assessment visit. subjects will be scanned with ultrasound and lasca among other assessments shown in the info-graph and schedule of events. at the day of tooth extraction and socket augmentation (graft placement), clinical exams/measurements are taken, along with other research activities described in the info-graph and schedule of events. recovery (checkups) from surgery will be monitored at 2 weeks, 1 month and 2 months, and 3 months. the timepoints additional to normal clinical timepoints are needed to gather potentially diagnostic valuable information about graft maturation, which in the future may lead to an early graft failure decision or trigger other clinical steps such as infection management.

Eligibility criteria:
inclusion criteria: * patients at least 18 years of age and have at least a tooth that is considered hopeless, planned for an extraction and a bone grafting procedure for subsequent dental implant surgery. exclusion criteria: * patients not willing or not able to have an extraction, bone graft and subsequent implant surgery due to health, finance, or any other reasons.
clinical efficacy analysis of resveratrol in the treatment of primary ovarian insufficiency

Conditions: Primary Ovarian Insufficiency

Summary: resveratrol is a natural plant antitoxin widely found in grapes, mulberries, and other plants. resveratrol mediates a variety of pharmacological effects, including antioxidant, immunomodulatory, anti-inflammatory, and anti-apoptotic, and plays a protective and therapeutic role in the development of several ros-related diseases, including poi/pof.

the preliminary experiments of the investigators' group examined the gene expression in ovarian granulosa cells of poi patients and normal controls using high-throughput sequencing technology. the investigators found that the expression of nox complex ncf1, ncf2, ncf4 and cybb subunit genes were upregulated in ovarian granulosa cells of poi patients compared with normal controls, suggesting that the development of poi may be related to the nox complex subunit gene and the development of poi may be related to the abnormal expression of genes and proteins of nox complex subunits. based on the results of previous experiments and available literature reports, investigators compared ovarian function, embryonic laboratory indices, pregnancy outcome and cellular level nox/ros/oxidative stress changes of poi patients in the res-treated and non-res-treated groups by collecting blood and ovarian granulosa cell samples to analyze the effects, mechanisms of action and specific res application in antioxidant therapy for poi nox subunit targets to provide a reliable scientific basis for the clinical treatment of poi by res.

Eligibility criteria:
inclusion criteria: 1. amenorrhea or oligomenorrhea at least 4 months and two (\>4 weeks interval) basal fsh≥10miu/ml； 2. the women aged \<40 years old； 3. informed consent, voluntary experiment. exclusion criteria: 1. pregnant and lactating patients; 2. patients with endometriosis, adenomyosis, endometrial lesions (submucosal fibroids, endometrial polyps, etc.), uterine fibroids\>4 cm or hysterectomy; 3. patients with adrenal cortical hyperplasia or tumour； 4. ovarian neoplasms patients； 5. hydrosalpinx patients； 6. hyperprolactinemia patients； 7. patients who are participating in other clinical trials or have participated in other clinical trials within the past three months; 8. patients with a suspected or real history of alcohol and drug abuse; 9. known allergy to the investigational drug or its components; 10. other patients were deemed unsuitable for participation in this trial by the investigator.