Kornimate/medical-research-clean huggingface dataset:
study to investigate effect of a new drug (pf-00446687) in males suffering from erectile dysfunction

Conditions: Erectile Dysfunction

Summary: the purpose of this study is to investigate the effect of up to 200 mg of pf-00446687 on erectile activity in males suffering from erectile dysfunction as well as examining the safety and toleration of the drug.


Eligibility criteria:
inclusion criteria: * males aged 18-65 years who has given written informed consent to participate in the study and who suffers moderate to severe erectile dysfunction who has a current or recent successful response to treatment with phosphodiesterase type 5 inhibitors exclusion criteria: * males with a history of significant cardiac disease; unstable angina or recent myocardial infarction. * males suffering from treated or untreated hypo- or hypertension * males currently receiving vasoactive medication * males taking medications contraindicated, or cautioned with sildenafil or mc4 agonists
relma-cel followed by tislelizumab for the treatment of relapsed/refractory cns large b-cell lymphoma

Conditions: CNS Lymphoma

Summary: this study aims to evaluate the efficacy and safety of relma-cel in the treatment of central nervous system lymphoma (cnsl), as well as its pharmacokinetic characteristics. enrolled patients with relapsed/refractory (r/r) cnsl will receive relma-cel infusion, followed by tislelizumab treatment (200mg, iv, q4w, for 12 months) starting on day 35 after infusion. bruton's tyrosine kinase (btk) inhibitors will be used in combination as needed. the follow-up period will last for 4 years, monitoring drug safety, disease status, survival, and the pharmacokinetic characteristics of relma-cel.


Eligibility criteria:
inclusion criteria: 1. age greater than or equal to 18 years old, male or female; 2. relapsed or refractory cns-involved large b-cell lymphoma after at least first-line therapy, with an efficacy assessment of cr or pr after salvage therapy, and current stable efficacy status; 3. eastern cooperative oncology group (ecog) score of 0-2; 4. have a life expectancy of ≥ 12 weeks 5. use contraception 6. have adequate bone marrow and organ function: 1. neutrophil count (anc) ≥1.0 x 109/l; 2. hemoglobin ≥ 8.0 g/dl; 3. platelet count ≥ 50 x 109/l; 4. total bilirubin ≤ 1.5 × upper limit of normal (uln) 5. alanine aminotransferase/aspartate aminotransferase (alt/ast) ≤ 2.5 x uln or ≤ 5 x uln (in the presence of hepatic invasion); 6. creatinine clearance ≥40ml/min 7. lipase ≤ 1.5 x uln exclusion criteria: 1. severe active central nervous system symptoms 2. prior chimeric antigen receptor cellular immunotherapy targeting cd19 3. known human immunodeficiency virus (hiv) infection or positive immunoassay; 4. live vaccination within 30 days prior to study drug administration; 5. active autoimmune disease requiring systemic therapy in the last 12 months 6. allergy to the study drug or history of severe allergic reactions 7. potential risk of malignant cardiac arrhythmia 8. history of stroke or intracranial hemorrhage within 3 months prior to the date of administration of study medication 9. other malignant tumors presently or within 3 years prior to enrollment 10. conditions that, in the judgment of the investigator, would interfere with full participation in the study; pose a significant risk to the subject; or interfere with the interpretation of the study data 11. pregnant or lactating patients;
upar pet/ct in radium-223-dichloride treatment of patients with metastatic castration-resistant prostate cancer

Conditions: Prostate Cancer Metastatic; Bone Metastases

Summary: the purpose of this study is to investigate the applicability of urokinase plasminogen activator receptor (upar) positron emission tomography (pet) / ct molecular imaging in patients with metastatic castration-resistant prostate cancer (mcrpc)

68ga-nota-ae105 is a radioligand targeting urokinase plasminogen activator receptor (upar), which is a promising imaging biomarker of tumor aggressiveness. 68ga-nota-ae105 pet/ct will be applied in patients with mcrpc during treatment with radium-223. pet/ct will be performed before initiation of radium therapy and after two treatment cycles. the initial semiquantitative uptake (standard uptake values, suvs) of 68ga-nota-ae105 in metastases as well as the change in these parameters after therapy will be correlated with overall survival and progression free survival.

Eligibility criteria:
inclusion criteria: * metastatic castration resistant prostate cancer * approved to receive radium-223 therapy * written and oral consent exclusion criteria: * lack of communication skills * other known malignant disease * known allergy towards imp * severe claustrophobia * if a participant exhibits allergic reaction i the imp, the participant will be excluded from further participation in the study
robotic pyelolithiotomy versus percutaneous nephrolithotomy (pcnl).

Conditions: Renal Stone

Summary: prospectively randomized study in patients with renal pelvic stones who are candidate to standard pcnl procedure. one to one, controlled clinical trial. patients will be randomly allocated into two groups, 20 patients in each group. group a will be scheduled to receive routine standard pcnl. group b will be scheduled to receive robot assisted pyelolethotomy.


Eligibility criteria:
inclusion criteria: 1. age above 18 years. 2. renal stones ≥2 cm. 3. patients are candidate to pcnl. 4. patient with ecog performance score of 2 and less. 5. able to give informed consent 6. able to discharges home at the same day. exclusion criteria: 1. renal stones \< 2cm and can managed by another technique. 2. known with psychological disease.
vats major lung resection for chinese early-stage non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: surgery may be the best treatment choice for early stage non-small cell lung cancer. and vats major lung resection have been preferred as a standard radical procedure for early stage non-small cell lung cancer (nsclc).this study aim to investigate the outcome of vats major lung resection for lung cancer as a real-world study in china.

surgery may be the best treatment choice for early stage non-small cell lung cancer. and vats major lung resection have been preferred as a standard radical procedure for early stage non-small cell lung cancer (nsclc).this study aim to investigate the outcome of vats major lung resection for lung cancer as a real-world study in china.this is a multicenter, prospective study, aimed to evaluate the short-term and long- term outcome of vats major lung resection for early stage lung cancer. patients will be followed up every 3 months for 3 years.

Eligibility criteria:
inclusion criteria: preoperative criteria: i) non-small cell lung cancer is suspected, ii) clinical stage i/ii (3) intraoperative criteria: i) histologically confirmed nsclc, ii) resected by vats or converted open lobectomy,sleeve lobectomy or pneumonectomy and nodal dissection/sampling. (4) no prior ipsilateral thoracotomy (prior diagnostic thoracoscopy is allowed). (5) no prior chemotherapy or radiation therapy for any malignant diseases. (6) expected postoperative fev1.0\>=800 ml and pao2\>=65 torr. (7) performance status of 0 or 1. (8) sufficient organ functions. (9) written informed consent. exclusion criteria: 1. active bacterial or fungous infection. 2. simultaneous or metachronous (within the past 5 years) double cancers. 3. women during pregnancy or breast-feeding. 4. interstitial pneumonitis, pulmonary fibrosis, or severe pulmonary emphysema. 5. psychosis. 6. systemic steroids medication. 7. uncontrollable diabetes mellitus. 8. uncontrollable hypertension. 9. history of severe heart disease, heart failure, myocardial infarction within the past 6 months or attack of angina pectoris within the past 6 months.
a phase 1b study of medi4920 in participants with adult-onset rheumatoid arthritis

Conditions: Adult Onset Rheumatoid Arthritis

Summary: the purpose of this study is to determine whether vib4920 (formerly medi4920) is safe and well tolerated in participants with adult-onset rheumatoid arthritis (ra).

study with completed results acquired from horizon in 2024. originally viela bio was the sponsor.

Eligibility criteria:
inclusion criteria: * adult-onset rheumatoid arthritis * swollen and tender joints exclusion criteria: * venous thromboembolism or arterial thrombosis * pregnant or breastfeeding * positive hepatitis b, hepatitis c, and human immunodeficiency virus infection * active or untreated latent tuberculosis

Keywords: medi4920, vib4920, cd40l, ra, rheumatoid arthritis
microbial markers for agi

Conditions: Acute Gastrointestinal Injury

Summary: agi is very common in icu and sometimes will trigger the development of gut derived sepsis. thus, to find out the biomarker in early stage is very important to improve the overall prognosis of critically ill patients. in this project we try to find out the microbial biomarker of agi through multi-omic technology.


Eligibility criteria:
inclusion criteria: all those critically ill patients with anticipated icu stay for more than 2 days exclusion criteria:patients will be excluded if they have any of the following situations: patients who have not signed the informed consent; unable to tolerate intra-abdominal pressure monitoring; pregnant woman; patients after bladder surgery; systemic diseases and recent use of related drugs; he had a history of infectious diseases, such as tuberculosis or ppd positive. history of hypertension and poor blood pressure control (sbp / dbp \> = 140mmhg); patients with severe mental illness; long term use of traditional chinese medicine, probiotics, gastric mucosal protective agents, proton pump inhibitors, chemotherapy or immunosuppressive drugs, etc. were not included if the drug was not stopped within one month before admission. -

Keywords: microbiome metabolome biomarker
covid-19 infection and epithelial cell markers

Conditions: Asthma; Covid19

Summary: to assess if tslp expression by airway epithelial cells following covid-19 infection regulates viral load and disease severity.

the study aim is to determine the relationship between covid-19 infection and epithelial cell expression of tslp. two cohorts will be used. cohort one will include 100 hospitalized patients with covid-19, and 100 hospitalized patients without covid-19. cohort 2 will include mild/moderate asthmatics and healthy controls with bio-banked biopsy material used from donors who have previously consented for samples to be used for future research.

Eligibility criteria:
inclusion criteria: * age 18 years and above; * able to give informed consent; * clinically tested for sars-cov-2 (as completed by standard laboratory testing e.g. rt-pcr) and with a positive result and clinical features in keeping with covid-19 illness. the control group will be patients with a negative rt-pcr covid-19 test and without any clinical features to suggest covid-19 illness. in addition, the control group should have no known or current features of respiratory infection, copd, asthma, interstitial lung disease, other respiratory inflammatory conditions or lung cancer. * able to provide a breath sample (as based on clinical judgement). exclusion criteria: - none
evaluating interventions for alcohol use disorder

Conditions: Alcoholism

Summary: the purpose of this study is to investigate how behavioral treatments for alcohol use disorders affect behavior change.


Eligibility criteria:
inclusion criteria: study inclusion criteria are such that study participants must: 1. meet a diagnostic and statistical manual-iv (dsm-iv) alcohol abuse or dependence diagnosis based on the diagnostic interview schedule - iv (dis-iv); 2. consume a weekly average of at least 24 standard drinks during the baseline period to include at least 5 episodes of heavy drinking; 3. agree not to seek additional alcohol or other substance abuse treatment during the study period; 4. be at least 18 years of age; and 5. be sufficiently proficient in their english speaking ability to interact effectively with the research interviewer. exclusion criteria: * individuals assessed as having a drug diagnosis that is more severe than their alcohol diagnosis (e.g., cocaine dependence and alcohol abuse, iv drug use), * a serious psychiatric diagnosis (e.g., uncontrolled schizophrenia or major depression) as well as those meeting criteria for organic brain impairment, as measured by the mini-mental status examination section of the dis-iv will be precluded from study participation. in addition, * individuals reporting current enrollment in a substance abuse treatment program, * mandated to substance abuse treatment by a court order, or * severely socially unstable (e.g., homeless) also will be precluded from study participation.
genetic findings in a chinese family with axenfeld-rieger syndrom

Conditions: Genetic Findings in a Chinese Family With ARS

Summary: axenfeld-rieger syndrome (ars) is a rare autosomal dominant disorder, characterized by anterior segment abnormalities and systemic abnormalities. to date,two major genes, forkhead box c1 (foxc1) on chromosome 6p25 and pituitary homeobox 2 (pitx2) on chromosome 4q25, have been demonstrated to cause ars. in this study, we performed complete ophthalmologic examinations and analysis of foxc1 and pitx2 of a chinese family with ars.

two genetions of a chinese family with ars were recruited to aier eye hospital of changsha. clinical evaluations: we performed full ophthalmologic examinations of all subjects, including: visual acuity, intraocular pressure measurements (goldman), slit lamp, anterior segment photography, visual field test (humphrey 750, carl zeiss, germany), anterior segment oct (carl zeiss, germany). if the refractive medium is clear, we also performed funduscopy, gonioscopic and retinal nerve fiber layer (rnfl) thickness measurements (carl zeiss, germany). mutation analysis: about 2 ml of venous blood sampled from each subject and collected in vacutainer tubes (sanjiu medical technology co., ltd., liuyang, china) containing edta. genomic dna was extracted from each blood using a genomic dna mini kit for blood (life technologies), all coding exons, with flanking intronic regions, of foxc1 and pitx2 were amplified using pcr with primers. the amplifed dna was purifed by agarose gel electrophoresis and sequenced on a 3730/3700xl automated dna sequencer (applied biosystems).

Eligibility criteria:
inclusion criteria: * a chinese family with ars exclusion criteria: -

Keywords: axenfeld-rieger syndrom, genetic findings
a clinical study to evaluate safety of the exablate 2100 uf v2 system in the treatment of symptomatic uterine fibroids

Conditions: Uterine Fibroids; Bleeding; Pain

Summary: the first magnetic resonance-guided focused ultrasound (mrgfus) treatment of uterine fibroid using the exablate 2000 system was performed in 2001. since then, more than 5000 treatments were done in more than 60 different hospitals around the world. the experience accumulated in this novel treatment was collected by insightec and implemented into software and hardware updates, clinical tips and guidelines, all aimed to improve the clinical results and their durability, while maintaining a high level of safety. based on extensive clinical experience and our internal research and development effort goals toward continuous improvement in exablate treatment safety and performance, limited changes have been made to the current exablate system. this modified exablate system version is designated as the exablate 2100 uf v2 system. the modifications are believed to improve system's friendliness to the user, without introducing new risks or other issues of safety of the device, and should not have any negative impact on the safety or technical efficacy of the treatments for patients.


Eligibility criteria:
inclusion criteria: 1. women age 18 or older 2. symptomatic uterine fibroids, defined as those resulting in scores of 21 or higher, based on patient responses to questions 1-8 of the uterine fibroid symptom and health-related quality of life questionnaire (ufs-qol). 3. women who have given written informed consent 4. women who are able and willing to attend all study visits 5. patient is pre or peri-menopausal (within 12 months of last menstrual period) 6. able to communicate sensations during the exablate procedure. 7. uterine fibroids, which are device accessible 8. fibroid(s) clearly visible on non-contrast mri. 9. fibroid(s) enhances on mr contrast imaging exclusion criteria: 1. women who are pregnant, as confirmed by serum/urine test at time of screening, or urine pregnancy test on the day of treatment 2. uterine size \> 24 weeks 3. patients who are breast-feeding 4. patients with active pelvic inflammatory disease (pid). 5. patients with active local or systemic infection 6. contraindication for mri scan: 1. severe claustrophobia that would prevent completion of procedure in the mr unit 2. weight greater than 250 ibs (113kg) 3. implanted ferromagnetic materials and/or devices contraindicated for mr scan 4. known intolerance to mri contrast agent (e.g. gadolinium or magnevist) 5. any other contraindication for mri scan 7. extensive abdominal scarring in the beam path 8. dermoid cyst obstructing the treatment path. 9. known pelvic malignant or pre-malignant conditions 10. intrauterine device (iud) anywhere in the treatment path

Keywords: uterine fibroids bleeding pain quality of life mr guided focused ultrasound
the safety and effectiveness of retrovir in hiv-infected patients who have problems related to the nervous system

Conditions: HIV Infections

Summary: to assess the efficacy of retrovir (azt) therapy in the treatment of hiv ab positive persons with impairments in neuropsychological functioning. to assess the safety, virologic, and immunologic effects of azt therapy in hiv ab positive persons with neuropsychological impairment but minimal other symptomatology.


Eligibility criteria:
exclusion criteria co-existing condition: patients with the following are excluded: * neuropsychological (np) impairments more severe than described in the inclusion criteria. * evidence of nervous system dysfunction being caused by factors other than hiv infection, including history of head trauma, multiple sclerosis, epilepsy, or presence of concurrent central nervous system (cns) infections or neoplasms, e.g., toxoplasmosis, primary or metastatic cns lymphoma, progressive multifocal leukoencephalopathy, cryptococcal or other fungal meningitis, and cns tuberculous infections. * lymphoma or other tumor requiring cytotoxic chemotherapy. concurrent medication: excluded: * other antiretroviral agents. patients with the following are excluded: * aids or advanced arc. * neuropsychological (np) impairments more severe than described above; i.e., defective performance on np test battery in 3 or more np areas on the np screening battery at 2 standard deviations below the mean. * evidence of nervous system dysfunction being caused by factors other than hiv infection, including history of head trauma, multiple sclerosis, epilepsy, or presence of concurrent central nervous system (cns) metastatic cns lymphoma, progressive multifocal leukoencephalopathy, cryptococcal or other fungal meningitis, and cns tuberculous infections. prior medication: excluded: * antiretroviral agents including zidovudine (azt). prior treatment: excluded within 3 months of study entry: * blood transfusion. impaired performance on a defined neuropsychological test battery. * asymptomatic hiv infection. * persistent generalized lymphadenopathy (pgl). * early aids related complex (arc). * seropositive for human immunodeficiency virus (hiv) demonstrated by positive elisa test and confirmed by western blot with no or minimal symptomatology or hiv infection. * ability to give informed consent or a person with durable power of attorney who can give informed consent. * willingness to be followed by the originating medical center for 1 year. history of drug or alcohol abuse.

Keywords: neuropsychological tests aids-related complex zidovudine
ffp usage in pediatric cv surgery

Conditions: Coagulopathy; Congenital Heart Disease

Summary: when small children undergo heart surgery with the heart-lung machine, in the past, blood products to help the blood clot such as fresh frozen plasma (ffp) was routinely used in children under 10kg. with blood clot monitoring technology, we feel that it might not be necessary to expose all children to ffp. we want to determine if those children who did not receive ffp bleed more or require more blood products as compared to those who did receive ffp while on the heart lung machine.

this will be a single center, retrospective study. our cohort will include pediatric patients between 4 and 8 kilograms undergoing congenital cardiac surgery with cardiopulmonary bypass between january 2019 and january 2023. patients will be divided into two groups: ffp given at onset of cpb and no ffp given intraoperatively. patients requiring ffp for heparin resistance and anti-thrombin iii deficiency will be excluded. patient clinical, surgical, and bypass characteristics, transfusion, and bleeding outcomes will be collected using redcap and via chart review using connect care.

Eligibility criteria:
inclusion criteria: * pediatric patients between 4 and 8 kilograms undergoing congenital cardiac surgery with cardiopulmonary bypass exclusion criteria: * patients requiring ffp for heparin resistance and anti-thrombin iii deficiency will be excluded
relative bioavailability study in healthy subjects to evaluate the pharmacokinetics of htl0009936 after one dose of prototype formulation

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to find a modified release oral tablet formulation for this drug, which will be safe and well tolerated.

the aim of the study is to develop a modified release oral tablet formulation that maintains plasma concentrations within the target therapeutic range, and is safe and tolerable.

Eligibility criteria:
inclusion criteria: * healthy males \& females * aged 18 to 65 years * body mass index of 18.0 to 35.0 kg/m2 * cyp2d6 (intermediate or extensive metabolizer) exclusion criteria: * subjects with a resting heart rate (hr) \>90 bpm, and/or systolic blood pressure (bp) \>150 mmhg, and/or diastolic bp \>90 mmhg * subjects with qt interval corrected for heart rate using fridericia's formula (qtcf) \>450 ms (males) or \>470 ms (females) * personal or family history of long qt syndrome or sudden death * subjects who are cyp2d6 (poor or ultra-rapid metabolizer)
cetuximab and cisplatin in the treatment of "triple negative" (estrogen receptor [er] negative, progesterone receptor [pgr] negative, and human epidermal growth factor receptor 2 [her2] negative) metastatic breast cancer

Conditions: Breast Neoplasm

Summary: the primary objective of this study is to determine whether overall response to cetuximab combined with cisplatin is better than overall response to cisplatin alone together with showing that the overall response for cetuximab and cisplatin was above a pre-specified threshold of 0.2 in the treatment of "triple negative" metastatic breast cancer. the secondary objective of this study is to compare the differences between the two treatment groups using the following criteria : progression-free survival (pfs) time, overall survival (os), time to response (ttr) and safety.


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of metastatic breast cancer (stage iv) * estrogen receptor \[er\] negative, pgr negative and her2 less than 3+ expression by immunohistochemistry (ihc) * no more than 1 prior chemotherapy received for treating this metastatic breast cancer * no more than 1 prior anthracycline and/or taxane regimen (either adjuvant or metastatic setting) * other protocol-defined inclusion criteria may apply exclusion criteria: * prior platinum agent * prior mitomycin * known history of brain metastases * other protocol-defined exclusion criteria may apply

Keywords: cancer breast metastatic triple negative