Kornimate/medical-research-clean huggingface dataset:
role of positron emission mammography (pem) flex solo ii positron emission tomography (pet) scanner in evaluating neoadjuvant chemotherapy response in patients with breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is: 1. to evaluate the hypothesis: can pem flex solo ii pet scanner ascertain response to neoadjuvant chemotherapy in patients with breast cancer? 2. to compare the results from the pem flex solo ii pet scanner to the standard of care bilateral breast mri.

subjects will receive bilateral (both sides) breast and axillary pem scans. all recruited subjects chosen for the study will have biopsy proven breast cancer and are eligible for chemotherapy. they will undergo bilateral breast mri for staging which is considered standard of care. breast mri and pem scans will be performed at at baseline (phase 0 or pre-operative phase), 2nd mri and pem after 1 to 2 weeks of nac (phase 1) and 3rd mri and pem after 1 to 2 weeks of phase 1 (phase 2). dce-mri and pem will be performed not more than 14 days apart within each phase. cranio-caudal (cc) and medial lateral oblique (mlo) pem views will be performed of both the ipsilateral and contralateral breast and axillae by a mammography technologist trained in mammographic positioning.

Eligibility criteria:
inclusion criteria: * women 18-75 years old with newly diagnosed breast cancer who are considered candidates for breast conserving surgery (i.e., lumpectomy) exclusion criteria: * children (\< 18 years old) * pregnant or lactating women * diabetic patients (type i or ii) * patients who are scheduled for a sentinel node procedure using radioactive tc-99m within 24 hours of pem * patients who have not undergone a standard of care bilateral breast mri
volatile organic compounds in cystic fibrosis

Conditions: Cystic Fibrosis; Pseudomonas Aeruginosa

Summary: this experiment is designed to test the effectiveness of a new electronic nose device, which allows a non-invasive breath test for markers of lower respiratory tract infection, which may predict the probability of bacterial organisms in the lower respiratory tract. it consists of: * a breath collection apparatus for collection of volatile organic compounds in breath onto a sorbent trap and tedlar bag, as well as for the collection of a separate sample of room air. * analysis of the volatile organic compounds in breath and room air by short acoustic wave/gas chromatography. * interpretation of the volatile organic compounds with a proprietary algorithm in order to predict the probability of lower respiratory tract colonization and infection. this study will test the hypothesis that the investigators can identify the presence of pseudomonas aeruginosa by sampling the "head space" above culture media of sputum provided by patients with cystic fibrosis. this study will test the additional hypothesis that the investigators can identify the presence of pseudomonas aeruginosa by sampling exhaled breath from the patient providing the sputum.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of cystic fibrosis * must be able to give breath and sputum samples exclusion criteria: * heavy smoker * inability to regularly give breath and sputum samples * history of additional pulmonary disease

Keywords: cystic fibrosis pseudomonas aeruginosa volatile organic compounds electronic nose gas chromatography
study of dna samples from patients with multiple myeloma

Conditions: Multiple Myeloma and Plasma Cell Neoplasm

Summary: rationale: studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that may occur in dna and identify biomarkers related to cancer. purpose: this laboratory study is looking at dna samples from patients with multiple myeloma.

objectives: * determine whether there is an increased frequency of 1 or more polymorphic alleles that are associated with clinical endpoints using custom myeloma single nucleotide polymorphism (snp) chip analysis of banked dna samples from patients with multiple myeloma. * determine snps associated with toxicities caused, not by variations in tumor cell genetics, but by individual genetic variations affecting drug activation, distribution, metabolism, and export (adme). * determine snps associated with response, influenced by the same adme. * determine snps associated with bone disease (as a variable) among patients with multiple myeloma. * determine snps associated with epidemiology (i.e., risk factors for the development of multiple myeloma). outline: this is a retrospective, multicenter study. banked dna samples are analyzed using a custom single nucleotide polymorphism (snp) chip to assess approximately 3,590 snps from 1,061 genes that are associated with myeloma growth and response. projected accrual: a total of 600 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of multiple myeloma * dna samples banked from other ecog studies (and other clinical trial groups \[e.g., swog and mrc\]) patient characteristics: * not specified prior concurrent therapy: * not specified

Keywords: stage i multiple myeloma stage ii multiple myeloma stage iii multiple myeloma refractory multiple myeloma
switch on: analysing the immunogenicity of additional booster vaccinations in hcw

Conditions: Covid-19 Vaccination

Summary: eighty percent of the dutch population has completed a primary covid-19 vaccination regimen, and 60% of the population received a booster vaccination. waning immunity, combined with the emergence of antigenically distinct sars-cov-2 variants, has led to the consideration of additional booster vaccinations in the dutch population by autumn 2022. however, despite efforts of the dutch policymakers, the public's willingness to repeatedly receive covid-19 booster vaccinations is declining. this is mainly due to a reduced burden of disease by covid-19, fewer hospitalizations, and fewer deaths. however, population immunity might be one of the major factors responsible for this reduced burden of disease, possibly emphasizing the need for booster vaccinations. in this proposal we will address an important question asked by policymakers: "are booster vaccinations in autumn recommended for the healthy population?"


Eligibility criteria:
inclusion criteria: 1. participant is willing and able to give written informed consent for participation in the trial. 2. adult (male/female) between 18 and 65 years old 3. sufficient level of the dutch language to undertake all study requirements exclusion criteria: 1. adults younger than 18 or older than 65 years. 2. adults primed with another vaccine than janssen, moderna or pfizer. 3. history of allergic reactions likely to be exacerbated by any component of study vaccines (e.g. hypersensitivity to the active substance or any of the smpc-listed ingredients of the janssen/pfizer/moderna vaccine). 4. adults that are pregnant. 5. currently being treated for cancer. 6. severe kidney failure or dialyses dependent. 7. status after organ-, stem cell- or bone marrow transplantation. 8. use of immunosuppressant's. 9. epilepsy. 10. hiv. 11. bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding of bruising following im injections of vene puncture. 12. continuous use of anticoagulants, such as coumarins (e.g. acenocoumarol) or novel oral anticoagulants (i.e. apixaban, dabigatran etc). 13. participants who are currently participating in another research trial. 14. all regular contra-indications of the vaccines will be applied.

Keywords: covid-19 boost
subcuticular absorbable staples versus conventional skin closure in women undergoing cesarean delivery

Conditions: Operative Time; Wound Heal

Summary: despite the high numbers of cesareans being performed, scientific evidence behind which surgical techniques are best remains uncertain. our objective is to determine if subcuticular absorbable staples improve operative time and wound cosmetics.

this will be an open-label randomized controlled clinical trial. women undergoing cesarean delivery will be randomized to have either standard wound closure with monocryl suture or absorbable subcuticular staples placed by insorb skin stapling device. the insorb under the skin stapling device is fda approved but not currently used as standard of care at utmb. we will exclude women with intraamniotic infection, immunosuppression, active skin infection, those unlikely to be followed-up after delivery, or unable to provide consent.

Eligibility criteria:
inclusion criteria: * 18-50 years of age * women ≥ 24 weeks viable gestation * will be undergoing cesarean delivery exclusion criteria: * patient unwilling or unable to provide consent. * no or very limited prenatal care or a non-resident patient who is unlikely to follow-up after delivery. * immunosuppressed subjects: i.e., taking systemic immunosuppressant or steroids (e.g. transplant subjects; not including steroids for lung maturity), hiv with cd4 \<200, or other * decision not to have skin closure (e.g. secondary wound closure, mesh closure) * current skin infection * coagulopathy * high likelihood of additional surgical procedure beyond cesarean (e.g. scheduled hysterectomy, tubal ligation, bowel or adnexal surgery) * incarcerated individuals * intraamniotic infection * subjects participating on other treatment trials or studies that would interfere with the current study's primary outcome.
male factor infertility across india using aphrodite criteria

Conditions: Male Infertility Due to Azoospermia

Summary: study purpose: the purpose of this study is to conduct an observational cross-sectional analysis of male factor infertility across diverse regions of india utilizing the aphrodite criteria. this novel patient classification system offers a systematic approach to describing and managing male infertility, particularly for hypogonadal males with idiopathic infertility. the study aims to evaluate the current state of male fertility across india and identify any regional variations in male reproductive health and hypogonadism, which may be influenced by environmental, lifestyle, and genetic factors. study objective: the primary objective of this study is to conduct an observational cross-sectional analysis of male factor infertility across various regions of india using the aphrodite criteria. to reveal the prevalence and determinants of male factor infertility across different regions of india. hypothesis: we hypothesize that there are significant regional differences in male factor infertility characteristics across india, with variations in sperm quality and testicular function due to diverse environmental, lifestyle, and genetic factors. additionally, we hypothesize that the application of the aphrodite criteria will provide a more detailed classification of male infertility compared to conventional semen analysis and that certain lifestyle factors such as smoking, obesity, and occupational exposures will be associated with poorer sperm quality and testicular function. study population: the study population will consist of male patients visiting clinics across different ivf centers in india. the total sample size includes subjects from five groups with the following distribution: 35 subjects in group i ; 416 subjects in group ii; 270 subjects in group iii; 152 subjects in group iv; 216 subjects in group v the total sample size for all groups will be 1,090 subjects.


Eligibility criteria:
inclusion criteria: * all male visiting ivf clinic willingly giving consent for andrological evaluation. exclusion criteria: * none

Keywords: male infertility azoospermia aphrodite criteria prevelance
assessing the effect of the silver dressing on surgical site infections in adult patients post cardiac surgery: a single center randomized control trial

Conditions: Surgical Site Infection After Major Surgery; Surgical Site Infections

Summary: rct on post-cardiac surgery patients using silver dressings vs. standard care. conducted in icu, ccu, telemetry units. outcomes assessed via checklist \& modified parsonnet score. descriptive \& inferential statistics for analysis.

background the prevalence of surgical site infections in cardiac surgery is about 10%. about 3% of patients who develop an ssi will die as a result. multiple studies confirm that ssis are complications with significant sequelae, such as longer hospitalization, increased health costs, increased morbidity, and mortality. hence, the prevention and management of wound infections in median sternotomy incisions after adult cardiac surgery are crucial for optimizing patient outcomes, 5 aim to assess the effect of the silver dressing on ssi rates in adult patients post-cardiac surgery. methodology a single-center randomized control trial approach will be employed. adult patients admitted post-cardiac surgery with a sternotomy incision will be randomized into the intervention (n=78) or control group (n=77). units will include the cardiac surgical intensive care unit, the coronary care unit, and the cardiovascular telemetry unit. the intervention will include the use of a silver dressing on the sternotomy incisions and the donor sites where applicable. the control group will follow standard care processes. data collection will include a checklist and the modified parsonnet score. data analysis will include descriptive and inferential statistics. conclusion the current rate of surgical site infection amongst cardiac surgical patients is 2.1 below the benchmark of 2.9 with an operational goal of 2.1.

Eligibility criteria:
inclusion criteria: patients 18 years of age and older are scheduled for cardiac surgery requiring a sternotomy incision. exclusion criteria presence of a concurrent infection and any systemic antibiotic other than those used for perioperative prophylaxis. patients who died without an infection within thirty days following surgery. patients who had undergone another procedure through the same incision(s) within a year after enrollment in this study. patients who are a redo- such as needing debridement or an infection. patients who have an open chest patients on echmo patients excessively bleeding patients who require the surgery as an emergency patients with a known allergy to silver dressings -
augmenting gait in a population exhibiting foot drop with adaptive functional electrical stimulation

Conditions: Foot Drop

Summary: the objective of this study is to investigate the effects of personalized, adaptive, current-steering functional electrical stimulation (fes) of the lower leg to improve gait in people with foot drop.

adaptive, current-steering fes enables precise control over dorsiflexor and evertor muscles, allowing for personalized treatment to correct key foot drop characteristics including dorsiflexion at heel strike and ankle inversion during swing phase. all participants will receive adaptive fes of the dorsiflexors and evertors during back-to-back walking sets. participants completed up to three walking sets of unstimulated walking (pre-test) followed by lower-leg stimulated walking (post-test). the primary outcome measures include ankle dorsiflexion at heel strike and mean ankle inversion during swing phase. secondary outcome measures include foot angle at heel strike and single-side heel strike to toe strike time (heel-toe time).

Eligibility criteria:
inclusion criteria: adults aged 18-70 * lower extremity impairment that makes walking difficult or uncomfortable * capable of sitting, standing, and walking independently or with assistance * able to walk at least 50 feet independently or with assistance * able to understand and follow basic instructions in english exclusion criteria: * have non-reversible damage to the peripheral nervous system * have underlying pre-existing conditions like thrombosis/hemorrhage, severe epilepsy or other seizure disorder, severe atrophy or history of implanted electrical devices * have cognitive impairment that would prevent you from fully understanding the study and ability to provide informed consent * have lower motor neuron disease or injury that may impair response to stimulation * are pregnant * are under the age of 18 years old * have skin conditions of the affected lower limb, including cuts, burns or lesions
evaluation of the effect of roflumilast in hyperinflated copd patients using functional respiratory imaging

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: in this study the efficacy of roflumilast in addition to lama/laba therapy will be assessed using functional respiratory imaging. in total 40 chronic obstructive pulmonary disease (copd) patients, global initiative for chronic obstructive lung disease (gold) stages c and d, who are stable on laba/lama therapy and who are prone to dynamics hyperinflation will be included in this study. to indicate the susceptibility to dynamics hyperinflation patients should have a baseline borg fatigue score after the 6-minute walk test (6mwt) above 4. the patients will be randomized in such a way that 1 out of 2 patients will receive placebo and 1 the active component. image parameters will be assessed and the correlation with lung function and health related quality of life will be checked before and after treatment.


Eligibility criteria:
inclusion criteria: * male or female patient ≥ 30 years old * written informed consent obtained * patient with body mass index (bmi) ≥ 20 * female patient of childbearing potential who confirm that a contraception method was used at least 14 days before visit 1 and will continue to use a contraception method during the study * copd patient with gold stages c and d * patient with a borg fatigue score after the 6mwt on screening above 4 to indicate the susceptibility to dynamics hyperinflation * patient with smoking history of at least 10 pack-years * patient takes a combination therapy of laba/ lama at least 6 weeks before visit 1 * patient must be able to understand and complete the protocol requirements, instructions, questionnaires and protocol-stated restrictions exclusion criteria: * pregnant or lactating females * patient with severe immunological diseases and/ or severe acute infectious diseases * patient with heart failure as documented in the medical history or as defined by the investigator during the physical examination performed at visit 1 * patient with diagnosis of cancer (except basal cell carcinoma) * patient with a history of depression associated with suicidal ideation or behaviour * patient with moderate or severe hepatic impairment. * patient with lactose intolerance * patient is unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study. * patient who received inhalation corticosteroids (ics) within the last 6 weeks prior to the screening visit * patient who received any investigational new drug within the last 4 weeks prior to the screening visit or twice the duration of the biological effect of any drug (whichever is longer)

Keywords: pulmonary disease, chronic obstructive dynamics hyperinflation computed tomography scan ct scan functional respiratory imaging fri roflumilast pro
indocyanine green molecular fluorescence imaging technique using in diagnosis and treatment of primary liver cancer

Conditions: Liver Cancer

Summary: the of this study is to explore the clinical outcomes of indocyanine green molecular fluorescence imaging in local resection of primary hepatocellular carcinoma (cnlc ⅰa stage).

indocyanine green molecular imaging technique is often used in the surgical treatment of primary liver cancer. its application in hepatectomy of primary liver cancer is currently in the stage of case accumulation and clinical research. no prospective study has been conducted to determine the clinical efficacy of indocyanine green molecular imaging for local hepatectomy of primary liver cancer. on the basis of more than 1000 liver resection procedures, the investigators want to apply indocyanine green molecular imaging technology, a cheap, simple and radiation-free method, to guide surgical resection. the purpose is to assist surgical procedures and improve participants' tumor-free survival.

Eligibility criteria:
inclusion criteria: * first clinical diagnosis of primary liver cancer (china liver cancer staging, cnlc ia stage); * child-pugh grading standard of liver function was grade a or b; * 18-66 years old; * complete clinical case data; * limited surgical methods (local resection); * voluntarily participate in the study and sign the informed consent. exclusion criteria: * there are basic diseases that cannot tolerate surgery (such as severe cardiopulmonary cerebral renal insufficiency); * tumor thrombus or distant metastasis was found in main portal vein and primary branch, main hepatic vein and branch, main hepatic vein and inferior vena cava by preoperative imaging examination; * planned pregnancy, unplanned pregnancy and pregnancy; * preoperative child-pugh grading standard of liver function was grade c. * disease researchers that the investigator considers inappropriate to participate in this clinical trial.

Keywords: indocyanine green local resection
continuous versus intermittent nebulization therapy in acute asthma exacerbation at emergency department

Conditions: Asthma Exacerbation; Emergency Department; Nebulization

Summary: the goal of this clinical is to compare treatment outcomes between continuous nebulization and intermittent therapy in the management of acute exacerbation of asthma in the emergency department(ed). participants will random assign to either continuous or intermittent nebulization. in the continuous group, patients receive budesonide, fenoterol, ipratropium bromide, and normal saline continuously for an hour. in the intermittent group, the same medications are administer every 20 minutes for an hour. measurements include symptom severity, respiratory rate, oxygen saturation, and pulmonary function tests. primary endpoints are ed stay length, hospital admission, and ed revisit within 48 hours post-discharge. adverse events are documented.


Eligibility criteria:
inclusion criteria: * asthma exacerbation exclusion criteria: * life-threatening conditions requiring intubation * allergy to steroid or its components * patient under investigation of corona virus disease, 2019 (covid-19) * pulmonary tuberculosis * unable to cooperate for pulmonary function testing

Keywords: asthma exacerbation continuous nebulization intermittent nebulization