Kornimate/medical-research-clean huggingface dataset:
role of 3d tomography in breast cancer

Conditions: Breast Cancer

Summary: the primary aim of this pilot study is to define the role of dedicated cone beam breast computed tomography in breast cancer imaging. this research is a prelude of a more comprehensive clinical trial that may follow.


Eligibility criteria:
inclusion criteria: * all women, age 40 or older, who are scheduled for biopsy after classification as bi-rads 4/5 and have had a screening or diagnostic full-field digital mammography (ffdm) exam are eligible to participate, except for exclusions noted below. * able to provide informed consent. exclusion criteria: * males * women less than 40 years old * pregnant women * lactating women * woman who have had bilateral mastectomies * women with physical limitations that may prohibit resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pace maker * women who are unable to tolerate study constraints, frail or unable to cooperate * women with large breasts that cannot be accommodated within the field of view of the ct system * women who have received radiation treatments to the thorax for malignant and nonmalignant conditions, such as (but not limited to) * treatment for enlarged thymus gland as an infant * irradiation for benign breast conditions, including breast inflammation after giving birth * treatment for hodgkin's disease * women who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram. * women who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to) * tuberculosis * severe scoliosis

Keywords: breast cancer, ct scans, mammography
safety, tolerance, efficacy and pharmacokinetics of multiple doses of scd4-pe40 in the treatment of hiv-infected individuals

Conditions: HIV Infections

Summary: to investigate the safety and tolerance of an increasing number of infusions per week of alvircept sudotox ( scd4-pe40; soluble cd4-pseudomonas exotoxin ) at a fixed dose when administered to hiv-1-infected individuals. to investigate the effect of scd4-pe40 on the following parameters: t lymphocyte subsets, plasma hiv rna and cellular hiv proviral dna in pbmc and cd4 cells, p24 levels, serum beta-2 microglobulin, and neopterin levels.


Eligibility criteria:
inclusion criteria patients must have: * hiv positivity confirmed by western blot. * cd4 count of 100 - 500 cells/mm3 on a morning draw within 3 weeks prior to study entry. exclusion criteria co-existing condition: patients with the following symptoms and conditions are excluded: * concurrent neoplasms other than basal cell carcinoma of the skin, in situ carcinoma of the cervix, or nondisseminated kaposi's sarcoma. * hemophilia or other clotting disorders. * major organ allograft. * significant cardiac, hepatic, renal, or cns disease. prior medication: excluded: * antiretroviral agents within 2 months prior to study entry. * known anti-hiv medication within 60 days prior to study entry. * prior immunomodulators (e.g., systemic steroids, interferons, or interleukins) or other chemotherapy. prior treatment: excluded: * prior radiation therapy. active substance abuse.

Keywords: recombinant proteins acquired immunodeficiency syndrome antigens, cd4 aids-related complex
safety and tolerability and efficacy of lcz696 in japanese hypertensive patients with renal dysfunction

Conditions: Hypertension With Renal Dysfunction

Summary: this study assessed the safety, tolerability, and efficacy of lcz696 in hypertensive patients with renal dysfunction.


Eligibility criteria:
inclusion criteria: * renal findings: hypertensive patients with renal dysfunction and stable renal condition at least 4 weeks before screening visit. * satisfy office mssbp ≥140 mmhg and \<180 mmhg at baseline. exclusion criteria: * patients show msdbp ≥110 mmhg and/or mssbp ≥180 mmhg. * history of angioedema, drug-related or otherwise, as reported by the patient. * any other following renal disorder: * patients show egfr \< 15ml/min/1.73m\^2 * patients on dialysis * patients who previously entered a lcz696 study and had been randomized or enrolled into the active drug treatment epoch. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: hypertension renal dysfunction lcz696
spinal manipulation effectiveness in spinal disorders

Conditions: Low Back Pain; Cervical Pain; Pain

Summary: the aim of the present intervention study is to determine the effectiveness of manipulation techniques.

spinal manipulation of the spine will be assessed in patients with musculoskeletal disorders to determine the effects of different manual therapy approaches.

Eligibility criteria:
inclusion criteria: * currently suffering spinal related pain (neck, thoracic or lumbar). * not receiving additional treatment for the treated condition. exclusion criteria: * presence of red flags such as tumors or infection. * recent surgery. * fractures.
bioequivalency study of meloxicam tablets under fed conditions

Conditions: Inflammation

Summary: the objective of this study was the bioequivalence of a roxane laboratories' meloxicam tablets, 15 mg, to mobic® tablets, 15 mg (boehringer ingelheim) under fed conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. * treatment with known enzyme altering drugs. * history of allergic or adverse response to meloxicam or any comparable or similar product.

Keywords: anti-inflammatory
effect of treatment compliance training given to patients with bipolar disorder

Conditions: Quality of Life; Treatment Compliance

Summary: in bipolar disorder, treatment noncompliance is associated with high rates of recurrence and hospitalization. furthermore, it is reported that that treatment noncompliance disturbs the social functioning of patients and reduces the quality of life. improvement of the quality of life, social functioning and treatment compliance is as important as the long-term treatment of symptoms.this study aimed to determine the effect of treatment compliance training given to patients with bipolar disorder on treatment compliance, social functioning, and quality of life.

the aim is to determine the effect of treatment compliance training given to patients with bipolar disorder on treatment compliance, social functioning, and quality of life. the study was conducted with 38 bipolar disorder (n=17 intervention group; n=21 control group) using a quasi-experimental research design. patients were evaluated using a pre-test, post-test, monitoring test, "medication adherence rating scale (mars)", "social functioning scale (sfs)", and "world health organization quality of life instrument short form (whoqolbref-tr)." the measurements were taken 3 times: pre test, post-test and 3-months post-test.

Eligibility criteria:
inclusion criteria: * volunteering to participate, * being diagnosed with bipolar disorder, * being in the euthymic period, * being at the age of 18 or over, * being literate. exclusion criteria: * being in an acute period of exacerbation * actively using alcohol or psychoactive substances * having another psychiatric illness

Keywords: bipolar disorder treatment compliance training quality of life social functioning
cavitronic ultrasonic surgical aspiration (cusa) women's health study

Conditions: Vulvar Intraepithelial Neoplasia; Condylomata Acuminata

Summary: the study is a single arm, retrospective, single-center, post market registry. the purpose of this registry is to collect data to demonstrate the safety and performance of cusa® for the treatment of vulvar intraepithelial neoplasia (vin) and condyloma acuminata.

cusa® excel/clarity ultrasonic surgical aspirator system is indicated for use in the following surgical procedures where fragmentation, emulsification and aspiration of soft and hard tissue is desirable: * neurosurgery * gastrointestinal and affiliated organ surgery * urological surgery * general surgery * orthopedic surgery * gynecological surgery * laparoscopic surgery this registry adds data to support the safety and efficacy for a gynecological surgery indication expansion for the use of cusa in vulvar intraepithelial neoplasia (vin) and condyloma acuminata. information obtained from this retrospective registry will help inform a potential future prospective study for this indication in a real-world population.

Eligibility criteria:
inclusion criteria: * subject had been diagnosed with primary or recurrent vulvar intraepithelial neoplasia (vin) or condyloma acuminata, treated with cusa and confirmed by a cusa pathology report. * subject had post-operative visits completed at the gynecologic oncology practice. * subject had surgery with cusa between january 2010 and december 2022. exclusion criteria: not applicable

Keywords: gynecologic oncology vin vulvar intraepithelial neoplasia condylomata acuminata
tumor-targeted-nir-ii fluorescent molecular probes for the identification of breast cancer tissue and sln metastatic status

Conditions: Breast Cancer; Sentinel Lymph Node; Metastases; Margin Assessment

Summary: accurate evaluation of tumor boundaries in breast-conserving surgery is closely associated with reducing the second operation of patients. meanwhile, accurately assessing sentinel lymph node (sln) metastasis is crucial for determining the extent of axillary lymph node dissection (alnd) and minimizing complications. near-infrared-ii (nir-ii) fluorescence imaging using molecular agents has shown promise for in situ imaging during resection. however, very effective probes can be applied to clinical trials up to now, which limits the clinical application of fluorescence imaging. here we developed a new technology that can quickly differentiation between cancer and para-cancer tissue as well as metastatic and normal sentinel lymph nodes(sln). in brief, the fresh tissues were incubated with the probe immediately after intraoperative resection and imaged to identify the tumor area and distinguish the metastatic status of sln. the accuracy of fluorescence imaging was confirmed by pathological diagnosis.

after enrollment, the patients received surgical treatment according to clinical diagnosis and treatment.during the operation, the excised breast tissue and sln was incubated, and the specific procedure was as follows. 1. preparation of the incubation solution: the probe was dissolved in phosphate buffer saline(pbs) buffer as the incubation solution at room temperature in the dark,with varying concentrations (12.5, 25, 50,100 ug/ml). 2. in vitro incubation of fresh breast cancer or sln tissues: the fresh excision breast cancer and sln tissues were completely soaked in the incubation solution for about 1,3, 5, 7 or 10 minutes, followed by 5 minutes rinse with pbst buffer (pbs with tween 20) and drying with the use of absorbent paper. 3. analysis of the images in the "digital precision medicine(dpm)" nir-ii system. the dpm parameter was set up before scaling. then fluorescence imaging was performed with the dpm nir-ii system. and the result was analyzed to identify the tumor area and distinguish the metastatic status of sln. 4. confirmed the diagnosis by pathological examination.

Eligibility criteria:
inclusion criteria: * adult patients between 18-75 years of age * female * patients presenting with a breast nodule or mass presumed to be resectable on pre-operative assessment * good operative candidate * subject capable of giving informed consent and participating in the process of consent exclusion criteria: * patients unable to participate in the consent process * patients had contraindications to surgery, such as serious cardiopulmonary disease, coagulation dysfunction, etc * other conditions that the researcher considers inappropriate to participate in the study

Keywords: nir-ii breast cancer sentinel lymph node surgical navigation metastases
pet/mri to stage prostate cancer patients

Conditions: Prostate Cancer

Summary: the main goal of this phase ii clinical trial is to define a novel approach of staging prostate cancer (pca) patients by using a fully integrated positron emission tomography/ magnetic resonance imaging (pet/mri) system with 68ga-prostate specifica membrane antigen (psma) and 68ga-rm2 (bombesin antagonist). 50 patients with biopsy proven pca will be studied by pet/mri with 68ga-psma and with 68ga-rm2 and then will undergo prostatectomy and pelvic lymphadenectomy.

this is a prospective monocentric open study (phase ii study). the study will include 50 consecutive pca patients who will be recruited in the first 36 months of the study. all clinical and pathological variables available at the time of pet/mri will be recorded for each patient and all patients will take a blood sample before the first pet/mri study. all patients will undergo 68ga-psma and 68ga-rm2 pet/mri studies at san raffaele hospital in two different days (\> 48 hours between the two studies) and within one month from each other. then, patients will undergo surgical intervention (prostatectomy and pelvic/retroperitoneal lymphadenectomy) and the surgically removed prostate will be fixated and processed. ex-vivo 3t-mri study will be performed on the processed specimen (prostate gland) and afterwards, the prostate will be examined by a dedicated pathologist. spatial coregistration of in vivo, ex-vivo and histopathological images will be performed so that the annotation (dominant tumor lesion) made by the pathologist will be translated onto in vivo pet/mr images and semi-quantitative and radiomic features will be extracted from pet and mp-mri images

Eligibility criteria:
inclusion criteria: * age ≥ 18 years-old * biopsy proven high-grade pca referred to prostatectomy and pelvic/retroperitoneal lymphadenectomy. * willing to provide a signed informed consent exclusion criteria: * age \< 18 years-old * inability to complete the needed imaging examinations (i.e. severe claustrophobia) * any additional medical condition that may significantly interfere with study compliance * all the contraindications for mri study (i.e. pacemaker) * evidence of metastatic disease on conventional imaging contraindicating the surgical procedure
femoral vein hemostasis after ablation for atrial fibrillation with manual pressure versus a figure of 8 suture

Conditions: Atrial Fibrillation

Summary: patients who undergo ablation for af typically have 2 sheaths placed in each groin, including a large sheath when the cryo balloon is used for pulmonary vein isolation. during the procedure, heparin is administered to maintain a target act \> 300 seconds. at the conclusion of the procedure, the venous sheaths are removed and hemostasis is obtained. there are at least 2 ways of obtaining hemostasis after venous access. in the manual hemostasis approach, an act is checked and protamine is administered. the act is rechecked 20" later, and if \< 220 msec, the sheaths are pulled and hemostasis is achieved with manual pressure (manual hemostasis group). another approach is to place a figure of 8 suture around the sheaths in each groin to achieve hemostasis as the sheaths are removed, and therefore obviate the need for assessment of the act, protamine administration, and manual pressure (figure of 8 group).


Eligibility criteria:
inclusion criteria: * any patient who meets standard clinical criteria for an ablation of af with cryoballoon, and is to undergo the procedure exclusion criteria: 1. pregnant patients. 2. age \<18 years. 3. patients who cannot provide consent in english. 4. prisoners.
ketogenic diet for reduction of cns oxygen toxicity in working divers

Conditions: CNS Oxygen Toxicity, Ketogenic Diet

Summary: the purpose of this research study is to understand the effect of nutritional ketosis on cns oxygen toxicity in undersea divers. the investigators hope this will provide a starting point to develop methods for improving the safety of navy divers, warfighters and submariners.

participants in the study will undergo a physical exam and testing as well as training on cognitive testing software as part of the screening process. eligible subjects will be assigned a normal diet or a ketogenic diet (a diet high in fat/protein and low in carbohydrates) for three days before testing. subjects will be immersed in water to the shoulders, inside a hyperbaric (high pressure) chamber while breathing 100% oxygen at increased atmospheric pressure, and doing cycling exercise. testing on the cognitive software, as well as blood sampling and physical monitoring will be done while in the chamber. all tests and procedures will be completed again at least one week later with the diet not assigned for the first session.

Eligibility criteria:
inclusion criteria: * males \& females between 18 and 50 years old * able to pedal a bicycle ergometer continuously for 15 minutes * non-smoker * no history of cardiovascular disease, including coronary artery disease, valvular disease, cardiomyopathy or hypertension. * no history of lung disease exclusion criteria: * prolonged qtc on initial ecg * currently pregnant or attempting to become pregnant. * have a history of: 1. smoking 2. coronary artery disease 3. hypertension 4. seizures 5. exercise intolerance 6. psychiatric disorder 7. previous pneumothorax or pneumomediastinum 8. hypo or hyperglycemia 9. diabetes * regularly take any medications which may alter heart rate, blood pressure, neurotransmitter function, mood or affect.
understanding the determinants of physical activity levels in persons with chronic pain

Conditions: Chronic Pain

Summary: the proposed research topic will investigate the determinants of physical activity (pa) levels in patients with chronic pain. the aim of the research project is to quantify the self-reported and free-living physical activity levels in people with chronic pain. describe and explore the characteristics and relationships of these participants in terms of pain severity, fear of movement, patterns of activity, anxiety and depression, and number and differing types of long term conditions and how these all correlate with pa levels. explore pa levels of chronic pain patients and the correlation of psychosocial factors.


Eligibility criteria:
inclusion criteria: * individuals with pain lasting more than 12 weeks (chronic pain) * 16 years or older exclusion criteria: * none

Keywords: physical activity fear of movement patterns of activity psychological status
the symptomatic cerebral cavernous malformation trial of rec-994

Conditions: Cerebral Cavernous Malformation

Summary: this is a two-part, multi-center, randomized, double-blind, placebo-controlled study to investigate the safety, efficacy and pharmacokinetics of rec-994 (200 mg and 400 mg) compared to placebo in subjects with symptomatic cerebral cavernous malformation (ccm).


Eligibility criteria:
inclusion criteria: 1. 18 years of age or older with anatomic ccm lesions demonstrated by brain mri 2. have symptomatic ccm 3. have provided written informed consent to participate in the study 4. have not participated in a clinical trial utilizing an investigational agent within 28 days or within 5 half-lives of the investigational drug (whichever is longer) prior to screening exclusion criteria: 1. symptoms deemed by the study investigator to be caused exclusively by irreversible neuronal damage from prior stroke or neurosurgical instrumentation 2. history of cranial irradiation or surgical/radiosurgical treatment of the primary symptomatic ccm lesion 3. pregnant or breast feeding 4. be unable or unwilling to participate in mri assessments (e.g., claustrophobia, metal implant or implanted cardiac pacemaker) 5. liver dysfunction or active liver disease as defined by baseline serum transaminases \>2x upper limit of normal (uln) 6. have moderately or severely impaired renal function (estimated glomerular filtration rate \[egfr\] \<60ml/min) or active renal disease or have previously received a kidney transplant 7. have had a previous diagnosis of skeletal muscle disorders (myopathy) of any cause or have a baseline creatine kinase level \> 5x uln 8. history of alcohol or substance abuse within 1 year prior to screening 9. clinically significant laboratory abnormality 10. have had an intracerebral hemorrhage within 3 months of screening or any brain surgery within 6 months of screening (not including the primary symptomatic ccm lesion)
study to evaluate the use of renalguard to protect patients at high risk of aki

Conditions: Cardiovascular Disease; Acute Kidney Injury

Summary: the strength study aim to evaluate the use of the renalguard device to protect the patients at high risk to develop acute kidney injury following a complex cardiovascular intervention requiring a high volume of contrast.

the strength trial is a randomized, international (france and germany) and multicentre (7) trial. the patients population targeted is suffering from kidney insufficiency (estimated glomerular filtration rate (egfr) between 15 to 40 ml/min/m2) need to go through a complex cardiovascular intervention.. this is a population of patients at high risk to develop aki following contrast media administration and complex cardiovascular interventions require a high amount of contrast. standard treatment is hydration but with risk of hyper and hypohydration for this population of patients. renalguard insure the replacement of the urine output by infusion of a matched volume of sterile replacement solution to maintain patients' intravascular fluid volume. the patients are randomized to be protected from contrast-induced nephropathy with the use of renalguard or by standard hydration treatment and will be followed-up during 12 months.

Eligibility criteria:
inclusion criteria: * age \> 18 years old * 15 ml/min/m2 ≤ egfr ≤ 40 ml/min/m2 * high volume contrast-requiring cardiovascular procedures (estimated contrast volume \> 3 times egfr value) * patient has agreed to all fu testing exclusion criteria: * administration of iodine contrast media within 5 days before index procedure * emergency procedure or primary pci * patients with pulmonary edema or cardiogenic shock (killip 3 or 4) * hypoxemia defined as sao2 ≤ 90% and/or pao2 ≤ 80 mmhg on room air * acute kidney injury requiring dialysis before the procedure * multiple myeloma or cancer treated with chemotherapy * subjet is anuric * subject has been hospitalized for any change in renal function or has undergone renal replacement therapy (hemodialysis or hemofiltration) within the past month * known hypersensitivity to furosemide active ingredient or excipient * renal insufficiency with oligoanuria resistant to furosemide or caused by nephrotoxic or hepatotoxic substances * pre-coma or coma induced by an hepatic encephalopathy * severe hypokalemia, sever hyponatremia, hypovolemia with or without hypotension or dehydration * hypersensitivity to sulfamides * enrollment in another study unless the study is a registry or unless primary endpoint is reached * expected life expectancy \< 1 year * pregnant or breastfeeding patient * patient under trusteeship or guardianship * patient is unable / unwilling to provide an informed consent