Kornimate/medical-research-clean huggingface dataset:
contrast enhanced ultrasound and shear wave elastography in measuring response in patients with breast cancer receiving chemotherapy before surgery

Conditions: Breast Cancer

Summary: this pilot clinical trial studies contrast enhanced ultrasound and shear wave elastography in measuring response in patients with breast cancer receiving chemotherapy before surgery. new imaging procedures, such as contrast enhanced ultrasound and shear wave elastography, may predict treatment response earlier and more accurately than contrast enhanced magnetic resonance imaging.

primary objectives: i. to establish a quantitative prediction rule for accurate and early prediction of the pathologic tumor response assessed post-surgery, using the change of contrast enhanced ultrasound (ceus) assessed tumor size and perfusion characteristics before (baseline) and 2-3 weeks following initiation of neoadjuvant chemotherapy (nac). ii. to assess the agreement between ceus based classification rule and pathologically determined treatment response (baseline versus pre-surgical scan). iii. to establish a quantitative prediction rule for accurate and early prediction of the pathologic tumor response assessed post-surgery, using the change in propagation velocity of a shear mechanical wave in tissue before (baseline) and 2-3 weeks following initiation of nac. iv. to assess the agreement between shear wave elastography (swe) based classification rule and pathologically determined treatment response (baseline versus pre-surgical scan). secondary objectives: i. to explore the role of combined ceus + swe features obtained at early treatment phase (2-3 weeks following initiation of nac), in accurately predicting the pathologically determined tumor response. ii. to investigate the agreement in assessment of therapy response to nac between ceus versus contrast enhanced magnetic resonance imaging (ce mri) and swe versus ce mri for baseline versus pre-surgery scan and to identify discordant cases using scatter plot and contingency tables. outline: patients undergo dynamic contrast-enhanced ultrasound imaging and shear wave elastography at baseline, 2-3 weeks after initiation of chemotherapy, and before surgery.

Eligibility criteria:
inclusion criteria: * women with histologically confirmed breast cancer (by core needle biopsy) * women with \>= 2 cm clinically or radiologically measureable breast cancer * women scheduled to receive neoadjuvant chemotherapy as part of their treatment plan * women competent to sign study specific written informed consent * women willing to comply with protocol requirements exclusion criteria: * women who are pregnant * women who have undergone open surgical (excisional) biopsy for breast cancer diagnosis * women who have had a prior history of breast cancer in the same breast * women with known cardiac shunt, pulmonary hypertension or hypersensitivity to perflutren agent * women who cannot consent for themselves
concentrated saline infusions and increased dietary sodium with diuretics for heart failure with kidney dysfunction

Conditions: Congestive Heart Failure; Renal Insufficiency

Summary: at present the standard management of fluid overload in patients with congestive heart failure (chf) involves limiting the intake of salt and water while administering high dose diuretics, often at the cost of deteriorating kidney function. however, another group of researchers has previously shown that intravenously infusing small volumes of concentrated saline during diuretic dosing and liberalizing dietary salt intake while continuing to limit water consumption resulted in improved fluid removal in chf patients. furthermore, less deterioration in kidney function, shorter hospitalizations, reduced readmission rates, and even reduced mortality were observed. the present study will examine this novel therapy in a population of 60 patients with underlying severe chf and kidney dysfunction hospitalized for the management of fluid overload. half of these patients will receive investigational treatment with concentrated salt infusions and liberalized salt consumption during diuretic therapy. all patients will otherwise receive the standard therapies for heart failure, including restrictions on water consumption. this study will attempt to verify the improvements in clinical endpoints previously described and define the mechanisms of enhanced fluid removal.


Eligibility criteria:
inclusion criteria: * adult patients (age ≥18) admitted with chf exacerbation with nyha class iii-iv symptoms at screening. * left ventricular ejection fraction \</= 45%, as determined by previous echocardiogram, left ventricular angiogram, or thallium myocardial imaging. * estimated gfr \ /= 120 mg/d in furosemide equivalents or concomitant thiazide use). for gfr \<30: no additional criteria needed. exclusion criteria: * admit estimated gfr \< 15ml/min or predicted need for chronic hemodialysis within the next 60 days. * cause of acute kidney injury other than prerenal physiology. * no loop diuretic prior to admission or loop diuretic initiated within the 2 wks prior to admission. * medicine or dietary noncompliance expected to prevent successful study participation. * \> 36hrs since presentation to screening. * serum na \> 145 meq/l or \< 120 meq/l at screening. * systolic blood pressure \> 180 mmhg at screening. * presentation with acute coronary syndrome or left heart catheterization planned at screening. * current or impending respiratory failure at screening. * current calcineurin inhibitor or nesiritide use. * nephrotic-range proteinuria. * clinical evidence for the presence of cirrhosis with bilirubin \>/= 2mg/dl or international normalized ratio (not on coumadin) \>/= 1.7. * presence of another active medical issue which may prolong hospital admission or delay aggressive chf therapy. * participation in another interventional study. * pregnancy. * prisoners.

Keywords: congestive heart failure renal insufficiency hypertonic saline solution diuretic resistance cardiorenal syndrome
comparative study between pulsed and continuous itraconazole for the treatment of onychomycosis

Conditions: Onychomychosis

Summary: the term onychomycosis is used for a chronic fungal infection of the nail which when caused by dermatophytes, becomes tinea unguium. it not only includes the dermatophytes but also saprophytic molds infections and yeasts. thorough literature research has revealed that 90% toenail and 75% fingernail onychomycosis are a result of dermatophytes arguably by trichophyton mentagrophytes and trichophyton rubrum. comorbid conditions such as diabetes mellitus and peripheral arterial disease and immunosuppression due to hiv plays a catalytic role in its prognosis. in a study, upon comparison of placebo with continuous terbinafine 250 mg daily for 24 weeks and continuous terbinafine 250 mg daily for 16 weeks, no significant differences were observed by the researchers between the two methods i.e continuous and pulse regimens of terbinafine, itraconazole, and fluconazole respectively. moreover, in one another research study, the researchers also did not find significant superiority of continuous itraconazole 200 mg daily for 12 weeks over pulsed itraconazole 400 mg in the treatment of terms onychomycosis of mycological cure that is the reason why continuous daily itraconazole 200 mg for 24 weeks has so far performed best in rank probabilities over other therapies, but its clinical significance is still debated. the purpose of carrying out this study was to carry out comparison between pulsed and continuous itraconazole for the treatment of onychomycosis as previous literature shows ambiguous results, therefore, this study will cement the rare evidence pertaining to the efficacy of pulsed and continuous itraconazole in the treatment of onychomycosis in our local population


Eligibility criteria:
inclusion criteria: * patients age between 20-60 years * patients positive for fungus via direct microscopy due to the identification of hyphae or blastospores on the target toenail * patients positive fungal culture. patients who had not applied any topical agent to the target toenail for the last 1 month exclusion criteria: * pregnant patients * patients with poor adherence * lactating women. * patients previously allergic to oral itraconazole. * patients with elevated baseline liver function tests such as alt, ast, alkaline phosphatase, and total bilirubin twice the upper limit of normal * history of renal disease. * patients unresponsive to systemic antifungal therapy within the past year * history of using systemic immunosuppressants. * patients exhibiting evidence of ventricular dysfunction and history of congestive heart disease * immunocompromised patients
an observation study on neuropsychology and serum melatonin level in patients with medication overuse headache

Conditions: Medication Overuse Headache

Summary: medication overuse headache (moh) is a disabling and costly disorder which is characterized by chronic headache and overuse of different headache medications. patients with moh are more likely to coexist with affective disorders such as anxiety and depression, and are more likely to suffer from sleep disturbances than those with episodic headache. melatonin is a hormone secreted from the pineal gland. melatonin is an antioxidant, antinociceptive, hypnotic, anticonvulsant, neuroprotective, anxiolytic, sedative and analgesic. this observational study aims to investigate clinical characteristics of patients with moh and to explore the relationship between the serum melatonin level and medication overuse headache. researchers hope to provide a new idea for the clinical treatment of moh: melatonin can be used as an adjuvant therapy for moh in the future.

30 patients with moh，30 patients with episodic migraine and 30 age-matched healthy volunteers were recruited in the study. a series of neuropsychological test scale including hospital anxiety and depression scale (hads), pittsburgh sleep quality index (psqi) and leeds dependence questionnaire (ldq) were evaluated among all the recruited. blood samples were taken at 10 a.m. and centrifuged. the serum was separated and collected at -70 °c for the measurement of melatonin .

Eligibility criteria:
inclusion criteria: * subject has medication overuse headache. headache occurring on 15 or more days per month for more than 3 months. the number of medication days ≥10 days/month for triptans, ergotamine, opioids, combination analgesics, or multiple drug classes not individually overused; ≥15 days/ month for simple analgesic * subject has had 1-8 migraines per month over the previous 3 months * sign the informed consent exclusion criteria: * subjects combine with other pain syndromes and long-term oral analgesics are needed * history of bleeding disorders

Keywords: melatonin medication overuse headache migraine neuropsychology
investigation of laser assisted drug delivery of nanodox®

Conditions: Wounds and Injury

Summary: this is a self-controlled single-site study of healthy subjects receiving an ablative fractional co2 (carbon dioxide) laser procedure followed by topical application of nanodox® hydrogel (1% doxycycline). the study includes skin biopsies to evaluate the effects of nanodox® doxycycline monohydrate gel on wound healing after the ablative laser procedure. study subjects will be asked to do 2 visits of 4 hours in total over approximately 1 week. an optional third visit will take place approximately 6 weeks after visit 1. in this study, 20 subjects are expected to enroll with a goal of 12 healthy subjects to enroll and complete the study.

effective topical delivery of any pharmaceutical agent requires small molecule drugs to penetrate the epidermis, yet the absorption of topical products through the epidermis is limited. in this study, the investigators are looking for healthy volunteers who are eligible to help us to determine the safety and efficacy of ablative fractional laser therapy combined with nanodox. the investigators are doing the research to evaluate drug delivery of topical nanodox® hydrogel following ablative fractional co2 laser treatment and our secondary objective is to evaluate the efficacy of nanodox® for wound healing. subjects will have a screening visit to determine eligibility, 2 study visits when they will receive co2 ablative fractional laser treatment, nanodox® hydrogel application, and skin biopsies, and 1 optional study visit for wound healing assessment. laser procedure will happen only during visit 1, visit 2 will happen 2 days after visit 1, and visit 3 will happen approximately 6 weeks after visit 1. in total, 7 skin biopsies will be performed.

Eligibility criteria:
inclusion criteria: * subject must be able and willing to provide written informed consent and comply with the requirements of the study protocol; * subject must be able to read and understand english; * any gender and any fitzpatrick skin type; * age equal to or greater than 18 years old; * willing to sun protect treated area (sunscreen or cover the area with clothes) for the duration of enrollment in the study and 1 year after treatment. * subjects must be willing to undergo skin biopsies exclusion criteria: * participation in another investigational drug or device clinical trial in the past 30 days; * are pregnant or lactating; * history of allergic reaction to topical or local anesthesia; * history of allergic reaction to doxycycline or other tetracyclines; * regular intake of high doses of anti-inflammatory drugs (aspirin \>81 mg/day, ibuprofen, corticosteroids, etc.) , immunosuppressive drugs or biologics; * clinically significant abnormal findings or conditions which might, in the opinion of the investigator, interfere with study evaluations or pose a risk to subject safety during the study; * laser treatment in past six months; history of poor wound healing; * history of keloids; history of extreme photosensitivity; * history of severe hyperpigmentation; history of tattoos on thighs.

Keywords: wound drug-delivery
probiotics after discharge

Conditions: Microbiota; Bacteriophages; Infantile Colic; Growth

Summary: the influence of the preterm gut microbiota in health and disease has been well established. however, relatively little is known about how the microbiome changes after discharge and its relationship with growth, health and disease outcomes in the preterm population. this study aims to follow a cohort of preterm infants and explore the relationship of the later microbiome ('after discharge') with later growth and health outcomes in infancy. the study will also explore the effect of timing of stopping routinely administered probiotics on the post-discharge microbiome, infant feeding and outcomes such as colic. the investigators aim to longitudinally follow 40 infants born before 32 weeks gestation who have also taken part in the investigators microbiome study during their nicu stay (servis rec no: 10/h0908/39) and where microbiomic sampling has been adequately achieved. the investigators will collect stool at and beyond the time of anticipated discharge (beyond 34 weeks) targeted to include pre- and post-weaning, and again at a year. actual discharge timing of these infants varies, and is usually latest in the most immature infants, allowing an assessment of the influence of physical location (nicu vs home) as well as increasing age. using 16s ribosomal rna amplicon analysis, the investigators will assess bacterial colonisation of the gut and measure infant weight, length and head circumference at each time point. the investigators will use a parent questionnaire to assess daily crying time, parents' perceptions of colic severity using a visual analogue scale as well as vomiting and constipation for the two weeks before sampling.


Eligibility criteria:
inclusion criteria: * \<32 weeks corrected gestation * followed up in newcastle region exclusion criteria: -
zoledronic acid to prevent bone loss during androgen deprivation therapy for prostate cancer

Conditions: Bone Loss; Prostate Cancer

Summary: the primary objective of this study is to determine whether zoledronic acid (zometa) given once annually increases bone mineral density in men receiving hormone therapy for prostate cancer.

* patients will be randomized into 2 groups. at the screening visit, a bone mineral density test will be performed to determine if the patient has osteoporosis or not. patients with osteoporosis will be treated with zometa. patients without osteoporosis will be randomly assigned to receive either zometa or a placebo. * zometa is administered intravenously over a 15 minute prior once in this one year study. * all patients will asked to take an over-the-counter oral calcium (500mg daily) and a daily multi-vitamin (containing 400-500 i.u of vitamin d) during the study. * all patients will have clinic visits every 3 months for blood tests and to report any side effects they may be experiencing. at month 12, a bone mineral density test will be repeated.

Eligibility criteria:
inclusion criteria: * adenocarcinoma of the prostate * current androgen deprivation therapy with expected duration of treatment greater than or equal to 12 months * corrected serum calcium \> 8.4mg/dl and \< 10.6mg/dl * serum creatinine \< 2.0mg/dl exclusion criteria: * history of bone metastases by bone scan * treatment with bisphosphonate within one year * history of metabolic disease * chronic use of glucocorticoids, anticonvulsants, or suppressive doses of thyroxine within one year

Keywords: androgen deprivation therapy bone loss prostate cancer zoledronic acid zometa
physical activity level of patients with copd during pulmonary rehabilitation

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the aim of the project was to assess the acceptability of the device as well as adherence to the study. the objective of study was to assess physical activity in patients with copd during in-hospital pulmonary rehabilitation program. the number of steps, average energy expenditure expressed in met and kcal, and physical activity time during the consecutive 5 days of the rehabilitation stay were analyzed. physical activity level was continuously monitored to assess intensity during in-hospital procedures as well as during leisure time.

the aim of the project was to assess the acceptability of the device as well as adherence to the study. the objective of study was to assess physical activity in patients with copd during in-hospital pulmonary rehabilitation program. the number of steps, average energy expenditure expressed in met and kcal, and physical activity time during the consecutive 5 days of the rehabilitation stay were analyzed. physical activity level was continuously monitored to assess intensity during in-hospital procedures as well as during leisure time. patients participated in pulmonary rehabilitation program consisted of: * specific respiratory exercises for 30 minutes - relaxation exercises for breathing muscles, strengthening exercises the diaphragm with resistance, exercises to increase costal or chest breathing, prolonged exhalation exercise, chest percussion, once a day for 30 min, * training on a cycle ergometer, twice a day for 20-30 min.- until the heart rate reaches 70% of the hrmax (220-age), * fitness exercises - coordination and balance exercises, stretching exercises using elastic bands, balls rehabilitation, sensory pillows. performed in a standing position, kneeling, sitting, lying on side, abdomen and back, once a day for 30 min * schultz autogenic training, once a day 20 min.

Eligibility criteria:
inclusion criteria: * diagnosed copd; * agreement to participate in the study exclusion criteria: * pneumonia, tuberculosis and other respiratory inflammatory disease in all stages and forms * condition after a heart attack * diabetes * state after thoracic and cardiac surgery * heart failure (stage iii, iv ° nyha) * advanced hypertension * diseases and injuries that can impair the function of the musculoskeletal system of transportation * disturbances of consciousness, psychotic symptoms or other serious psychiatric disorders;

Keywords: copd physical activity sensewear armband
the clinical observation on taping after total knee replacement

Conditions: Total Knee Replacement

Summary: the investigators will conduct a single-blind, randomized controlled trial of 100 patients with total knee replacement. patients will be randomly assigned into a control group and an intervention group.both groups received same rehabilitation procedures after surgery,except intervention group also received taping applications throughout all rehabilitation period.then, the patients will be reevaluated to determine changes in lower extremity function, edema, pain,knee range of motion, and muscle strength of quadriceps femoris and hamstring.


Eligibility criteria:
inclusion criteria: 1. soft-tissue swelling and pain after total knee replacement 2. agree to participate the study and signing of informed consent exclusion criteria: 1. severe cognitive and language barriers that can not be used to evaluate patients with pain and swelling 2. failure of important organs, such as heart, lung, liver and kidney 3. deep venous thrombosis 4. thrombophlebitis 5. varicose veins (stage ii-ivaccording to marshall) and venous insufficiency (stadium 2-3 according to widmer) 6. participants with infection in the areas close to the knee joint, or allergy to tape 7. enrollment in another clinical trial involving physical therapy or an investigational drug

Keywords: total knee replacement taping rehabilitation edema pain
efficacy and safety of purified starch for adhesion prevention in colorectal surgery

Conditions: Adhesions Abdominal

Summary: intra-abdominal adhesion occurs in up to 90% of patients after abdominal surgery. many patient will undergo a second surgery for temporary stoma closure, therefore these ostomy closure operations can give an opportunity to evaluate adhesion caused by previous operations. this study was conducted to use second surgery to investigate the anti-adhesion effect of purified starch among patients who underwent colorectal surgery.

data was analyzed from the medical records of patients who underwent a second surgery after colectomy between january 2020 and april 2022. patient were allocated to either the purified starch group and control group. since january 2020, adhesion scores have been registered in operation note when patients undergo a second colorectal surgery. the primary outcomes in this study were adhesion severity and adhesion area. the secondary outcomes were operation time, blood loss, and postopera-tive complications.

Eligibility criteria:
inclusion criteria: * patients who underwent a second surgery after colorectal resection between january 2020 and april 2022 were enrolled into this study. exclusion criteria: * patients who underwent a second surgery less than 1 month after the first colorectal resection or who developed peritoneum carcinomatosis in the second surgery and patients younger than 20 years were excluded.