Kornimate/medical-research-clean huggingface dataset:
phase i clinical trials investigating the potential efficacy of axitinib in patients with a brca 1/2 mutations

Conditions: Breast Cancer; Ovarian Cancer; Breast Neoplasms; Ovarian Neoplasms; BRCA Mutation; HER2-positive Breast Cancer; HER2-negative Breast Cancer; HER-2 Protein Overexpression

Summary: this clinical trial is investigating the potential efficacy of axitinib after genetic testing in brca 1/2 mutation patients, regardless of her2 expression, who have progressed after at least one line of standard treatment or for whom there is no consensus treatment approach. the use of axitinib may help physicians plan for more effective patient care in combination with existing treatment protocols.

this clinical trial is investigating the potential efficacy of axitinib after genetic testing in brca 1/2 mutation patients, regardless of her2 expression, who have progressed after at least one line of standard treatment or for whom there is no consensus treatment approach. the use of axitinib may help physicians plan for more effective patient care in combination with existing treatment protocols. the addition of axitinib to existing treatment protocols and to fractionated irradiation without functional normalization of the tumor vasculature can significantly improve response to therapy, contributing to the breakdown of the metabolic symbiosis of adaptive drug resistance.

Eligibility criteria:
inclusion criteria: * histologically and immunohistochemically confirmed status of the tumor process * мale or female, age ≥ 18 years * karnofsky performance status ≥ 60 * signed informed consent and willingness/ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures exclusion criteria: * grade 3 bleeding nci ctcae prior to study enrollment * cardiac arrhythmias ≥2 according to nci ctcae with a corrected qt interval (qtcf) on the screening ecg \>480 ms. * pregnancy or breastfeeding. all female subjects of reproductive potential must have a negative pregnancy test (serum) prior to enrollment. male subjects must be surgically sterile or must consent to the use of effective contraception during therapy. * severe acute or chronic psychiatric condition or disorder with risk associated with participation in the study * congestive heart failure (chf) class iii or higher according to the new york heart association (nyha) * subjects with arterial thrombotic events / venous thrombosis in the previous 12 months (axitinib has never been studied in this population)

Keywords: axitinib inlyta ag-013736
a study to evaluate the safety and efficacy of inactivated varicella-zoster vaccine (vzv) as a preventative treatment for herpes zoster (hz) and hz-related complications in adult participants with solid tumor or hematologic malignancy (v212-011)

Conditions: Herpes Zoster

Summary: this is a randomized, double-blind, placebo-controlled study to assess the safety and tolerability of v212 when administered to adults with solid tumor malignancy (stm) receiving chemotherapy and to assess the impact of v212 on the development of herpes zoster (hz) in adults with stm receiving chemotherapy. the primary hypothesis is that vaccination with v212 will reduce the incidence of hz compared with placebo in adults with stm (lower bound of the 97.5% {one-sided α=0.0125} confidence interval \[ci\] for the estimated vaccine efficacy in adults with stm be \>25%). participants with hematologic malignancy (hm) were also enrolled and were to be originally included in the primary and secondary objectives and analyses. after an interim analysis demonstrated clear evidence of futility of v212 in the hm population, enrollment of this population was stopped and all hm-related objectives and analyses were made exploratory and are not reported in this record.


Eligibility criteria:
inclusion criteria: * has been diagnosed with an stm or hm and is not likely to undergo hematopoietic cell transplant (hct) and is either ≥18 years of age and receiving a cytotoxic or immunosuppressive chemotherapy regimen or is ≥ 50 years of age with a hematologic malignancy that is not in remission, whether on therapy or not * life expectancy ≥12 months * has prior history of varicella, antibodies to vzv (documented prior to receipt of blood products), or residence in a country with endemic vzv infection for ≥30 years or if participant is \<30 years old, attended primary or secondary school in a country with endemic vzv infection * is highly unlikely to conceive during the time period starting 2 weeks prior to enrollment through 6 months from last vaccination dose * female participants of childbearing potential must have a negative serum or urine pregnancy test exclusion criteria: * history of hypersensitivity reaction to any vaccine component * prior history of herpes zoster within 1 year of enrollment * has received or is expected to receive any varicella or non-study zoster vaccine * currently receiving or expected to receive long-term antiviral prophylaxis (\>4 weeks duration) with activity against herpes simplex virus (hsv), vzv or cytomegalovirus (cmv) * is pregnant or breastfeeding or expecting to conceive within the period of 2 weeks prior to enrollment throughout 6 months from last vaccination dose * has received a live virus vaccine or is scheduled to receive a live virus vaccine in the period from 4 weeks prior to dose 1 through 28 days postdose 4 * has received an inactivated vaccine or is scheduled to receive an inactivated vaccine in the period between 7 days prior to and 28 days following doses 1 through 4

Keywords: herpes zoster vaccine herpes-zoster-related complications immunocompromised herpes zoster-associated pain solid tumor malignancy hematologic malignancy
prehospital high-flow nasal oxygen therapy

Conditions: Acute Respiratory Failure With Hypoxia; Oxygen Inhalation Therapy; Prehospital Setting

Summary: the purpose of the present project is to compare high-flow nasal oxygen therapy with standard oxygen therapy, initiated in the prehospital setting in patients with acute hypoxemia respiratory failure, in terms of oxygenation at arrival to the hospital and need of mechanical ventilation during the subsequent 28 days

patients with respiratory distress and an spo2 below 90% in the prehospital setting will be randomized to receive either high-flow nasal oxygen therapy through a dedicated device or standard oxygen therapy through standard devices such as nasal cannula or face mask. need of mechanical ventilation either invasive or noninvasive from enrollment to day 28 and time course of oxygenation between first spo2 measured on scene and arrival to the hospital will be the main outcome measures.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * first spo2 on scene \<90% * at least one other sign of respiratory distress defined by (a) respiratory distress with a respiratory rate ≥ 25/min; (b) laboured breathing * no advance directives or known decisions of do not intubate or do not ventilate order. exclusion criteria: * known copd or other hypercapnic chronic respiratory failure * age \<18 years * pregnancy or breastfeeding * anatomical factors precluding the use of a nasal cannula * emergency intubation required * patients with tracheostomy * patient transported to a hospital not involved in the study

Keywords: respiratory insufficiency oxygen inhalation therapy
impact of pre-surgical nasal bacterial reduction on postoperative surgical site infections / standard care change

Conditions: Surgical Site Infection

Summary: patients presenting in the emergency department or admitted to the hospital with displaced hip fractures who require hemiarthroplasty or open reduction internal fixation or with spinal instability/fractures in need of urgent surgical intervention will receive treatment to reduce the number of microorganisms in their nose prior to surgery. after surgery, the subjects will be observed for any surgical site infections.

infection rate study.

Eligibility criteria:
inclusion criteria: * patients presenting in the emergency department or admitted to the hospital with displaced hip fractures who require hemiarthroplasty or open reduction internal fixation or with spinal instability/fractures in need of urgent surgical intervention will be enrolled in the study.
societal burden associated with type 1 diabetes in canada

Conditions: Type 1 Diabetes Mellitus; Quality of Life (QOL); Work Productivity; Caregiver Subjective Burden

Summary: the purpose of this observational study is to estimate the burden of t1d on caregivers of patient with t1d in terms of work productivity, healthcare resource utilization and quality of life.


Eligibility criteria:
inclusion criteria: 1. parental caregiver of a child recently diagnosed (\<= 2 years) with t1d before study inclusion; 2. age ≥18 ; 3. residence in the canada; 4. willingess to complete a 20-minute survey 5. ability to read and understand french or english; 6. signature of informed consent form (icf) exclusion criteria: 1. participation in a clinical trial.

Keywords: observational quality of life caregiver work productivity real-world
safety and exploratory efficacy of kanglaite injection in non small cell lung cancer

Conditions: Stage IV NSCLC

Summary: this study is for patients with advanced non small cell lung cancer that has progressed despite standard of care. the purpose of the study is to see if kanglaite injection has any effect on survival.


Eligibility criteria:
inclusion criteria: * confirmed (within last 3 months)progressive stage iv nsclc * estimated life span of 3 months * phase angle of at least 5 as measured by bioimpedance exclusion criteria: * currently taking a lipid lowering medications * has an imminently life threatening condition * has pre-existing liver disease * known allergy to soybeans * uncontrolled diabetes or uncontrolled disturbance of lipid metabolism * pregnant or lactating * has a pacemaker or other implantable electronic medical device
protect - the impact of a high protein diet on preservation of muscle mass

Conditions: Obesity

Summary: the present study is designed to investigate whether a high protein diet will preserve muscle mass during caloric restriction in older adults.


Eligibility criteria:
inclusion criteria: * overweight and obese subjects (bmi 27-40 kg/m2) * waist circumference male:≥ 102 cm, female: ≥ 88 cm * willingness and ability to comply with the protocol exclusion criteria: * renal insufficiency * co-morbidities * type 1 \& 2 diabetics (fasting glucose level ≥ 7 mmol/l) * cancer * copd * participation in weight loss program 3 months before the intervention * participation of any heavy resistance-type exercise training (\>1 wk) the last 2 y. * intentional or unintentional weight loss (\> 3 kg in the last 3 months) * severe loss appetite * diagnosed allergy to milk products * gastric bypass * supplements or medication use for weight loss * participation in any other intervention trial * women can only participate if they are postmenopausal (last period ≥ a year ago)

Keywords: muscle physical performance protein diet caloric restriction
diabetes prevention in women with a recent history of gestational diabetes (focus groups)

Conditions: Gestational Diabetes

Summary: the objective of this research is to conduct focus groups in order to adapt the diabetes prevention program (dpp) so that it may successfully target women diagnosed with gestational diabetes (gdm) who are at high risk for developing type 2 diabetes in the post-partum period. as this research seeks to gather formative data for a future intervention, the focus groups will: 1) provide information to maximize participation in the future intervention and 2) inform the location, content and format of the intervention. we will be conducting focus groups and informant interviews to determine the dpp modifications necessary for adapting to the post-partum lifestyles of women with a recent history of gdm. subjects will attend a 1 hour focus group or phone interview where they will be encouraged to respond to the facilitators' questions and to each other's comments on topics such as: gestational diabetes, healthy eating, exercise, and other type 2 diabetes prevention related activities. working with a variety of health care providers, including endocrinologists, obstetricians and nurse-practitioners, we will identify and enroll up to 60 women total who are either current gdm patients at bwh or have a recent history of gdm who have delivered at brigham and women's hospital in the last 5 years.


Eligibility criteria:
inclusion criteria: * healthy women ages 18-45 * diagnosis of gestational diabetes within the past 5 years (carpenter-coustan criteria) * english-speaking * currently not diagnosed with type 2 diabetes exclusion criteria: * diagnosis of type 2 diabetes * non-english-speaking
extracorporeal flow abolition in relation with primary insufficiency of great saphenous veins (gsv) using high intensity focused ultrasound (hifu) generated by sonovein: a multi center prospective pivotal study

Conditions: Chronic Venous Insufficiency

Summary: this is a multi-center series assessment with a planned accrual of 70 patients with diagnosed symptomatic primary gsv insufficiency. patients will be consented at a pre-study visit and evaluated for eligibility and for baseline characteristics of the disease. patients will receive treatment with sonovein for the targeted segments of gsv. at follow-up visits at 7 days (1 to 10 days), 3 months (+/- 20 days), 6 months (+/- 25 days), and 12 months (+/- 30 days) changes in veins and flow characteristics will be evaluated by ultrasound, and patient well-being, including pain which will be evaluated by patient-reported vas evaluations. continued follow-up for a total of 12 months will be completed prior to subject study exit. adverse events (ae) will be assessed at every study visit following hifu treatment.


Eligibility criteria:
inclusion criteria: * candidate for venous procedure with primary gsv insufficiency involving reflux in the segment to be treated * ceap-clinical classification ≥ 2 * physical condition allowing ambulation after the procedure. * agree to comply with the clinical investigation plan and follow-up schedule of the study * targeted tissue reachable for treatment with the device. * age over 22 years at the time of enrollment. * no acute venous thrombosis. * no complete or near complete deep vein post-thrombotic disease. * patient has signed and understood the written informed consent. exclusion criteria: * patient is pregnant * known allergic reaction to anesthetics to be used. * legally incapacitated or imprisoned patients * patient's vein target not clearly visible on the ultrasound images (in b mode) at the inclusion visit * patient participating in another clinical trial involving an investigational drug or device. * ankle-brachial index \<7 (abi) * undergoing active anticoagulant therapy within the last 6 months * diameter of the treated anatomical segment below ≤ 2mm \& above \> 20mm * patients where hifu cannot be delivered to tissues where macro calcifications induce a significant shadow in the ultrasonic image * patients where epack must be put in contact with an ulcer * patients with significant thick scars on the skin over the segment to be treated * security distance respected in regards of : * nerves \& bones * the surrounding vessels * patient who may not be considered as good candidates for treatment by the investigator outside the explicit exclusion criteria above listed

Keywords: varicose vein hifu theraclion
combined 18f-naf/18f-fdg pet/mri for detection of skeletal metastases

Conditions: Cancer

Summary: this clinical trial studies the use of sodium fluorine-18 (18f-naf) plus fluorine-18 (18f) fluorodeoxyglucose (fdg) positron emission tomography (pet)/ whole body magnetic resonance imaging (wbmri) to detect skeletal metastases in patients with stage iii-iv breast cancer or stage ii-iv prostate cancer.

eligible participants had previously received a bone scan using the radiolabel 99mtc-methyl diphosphonate (t99-mdp) as part of their regular medical care. 18f-naf and 18f-fdg are radioactive substances (radiolabels) that are absorbed by cancerous cells and allow for the cancer to be found using diagnostic procedures such as positron emission tomography (pet)/ whole body magnetic resonance imaging (wbmri). pet/wbmri is a combination procedure that combines the detailed pet images of areas inside the body from pet with the wbmri scans, and may help find and diagnose skeletal metastases in patients with breast or prostate cancer. it is not yet known whether 18f-naf/18f-fdg pet/wbmri is better than standard imaging methods in detecting skeletal metastases. eligible participants diagnosed with breast/prostate cancers and who have had 99mtc mdp bone scanning as part of their routine care are recruited and enrolled. participants then receive an 18f-naf/18f-fdg positron emission tomography (pet)/ wbmri combination scan. the pet/mri scans will be interpreted by 2 american board nuclear medicine (abnm)-certified physicians and 2 american board of radiology (abr)-certified radiologists, all with significant clinical experience, who are blinded to the subjects' medical history and the results of other imaging modalities. the scans will be analyzed and compared against each other, with a consensus read will be obtained for each scan. characterization of lesions as true-positive, true-negative, false-positive or false-negative will be done through a combination of clinical follow-up, imaging follow-up and/or histopathology findings. an overall diagnosis based on each scan will be determined on a 5-point scale (1=benign, 2=likely benign, 3=uncertain, 4=likely malignant, 5=malignant) to conduct a receiver operating characteristic (roc) analysis. if the diagnosis is positive for metastases on any of the scans, the investigator will identify the number of lesions and locations of positivity, and record this information. clinical is obtained at about 12 months after the initial scans.

Eligibility criteria:
all patients were enrolled after receiving a regular medical care bone scan using the radiolabel 99mtc-methyl diphosphonate (t99-mdp). inclusion criteria * ≥ 18 years old at the time of the drug administration * ≥ stage 3 breast cancer or ≥ stage 2 prostate cancer or prostate-specific antigen (psa) \> 10 micrograms/l or recurrent breast or prostate cancer * capable of complying with study procedures * able to remain still for duration of imaging procedure (about one hour) * written informed consent exclusion criteria * pregnant or nursing * metallic implants that contraindicate mri * renal function impairment that contraindicates mri
evaluation of efficacy of topical flutamide in the treatment of acne vulgaris

Conditions: Acne Vulgaris Superficial Mixed Comedonal and Inflammatory

Summary: from the obtained results, topical flutamide 1% gel can be a promising, effective, and safe alternative in treating patients with acne vulgaris with minimal side effects.

flutamide is a non-steroidal anti-androgen, which is used to treat patients with prostate cancer. due to its anti-androgenic properties can be used in cases of acne, hirsutism, and androgenic alopecia with successful outcomes. to minimize the unnecessary systemic side effects associated with the oral administration of flutamide. it has been shown that the topical delivery of flutamide can allow high drug levels at the site of action, decreasing the systemic side effects and improving patient compliance. the flutamide group received topical flutamide 1% gel twice daily on the face for 8 weeks and the control group received the same gel components, without flutamide, twice daily on the face for 8 weeks

Eligibility criteria:
inclusion criteria: * fifty adult patients with acne having inflammatory (papules and pustules) and non-inflammatory (comedones) of different sizes, distribution, and durations were included in this study. exclusion criteria: * patients with a history of acne treatment with systemic or topical antibiotics, retinoids, or hormonal therapy within the last 3 months. * patients with a history of chronic renal failure, hepatic insufficiency
antibiotics versus therapeutic ultrasound for sinusitis

Conditions: Sinusitis

Summary: question: is the effect of therapeutic ultrasound equally effective to antibiotic for treatment of sinusitis? design: a randomized clinical trial with concealed allocation, self-assessment by the subjects and intention-to-treat analysis.

subjects (n=48) with clinically diagnosed acute bacterial rhinosinusitis (abrs)will included. the antibiotic group will receive amoxicillin (500 mg) 3 times per day for 10 days. the ultrasound group will receive therapeutic ultrasound over sinuses at 1.0 w/cm2 in continuous mode for 10 minutes once a day for 4 consecutive days. improvement of symptoms (pain and congestion; numeric rating scale; 0-10) from day 1 to days 4 and 21 will be recorded. relapses, side-effects and satisfaction with treatment will be assessed at one-year follow-up.

Eligibility criteria:
inclusion criteria: * pain when bending forward, headache, pain in the teeth, purulent nasal secretion, "double worsening" and white blood cell count (wbc). * patients eligible for the study had to meet one of the first three criteria (pain when bending forward, headache, pain in the teeth) and all of the other indicators (purulent nasal secretion, double worsening, a left handed displacement of lymphocytes and a right handed displacement of granulocytes on the wbc as indication of bacterial infection). * subjects over 15 years of age were included. exclusion criteria: * subjects with any kind of antibiotic or allergic treatment within the last three weeks. * antibiotic intolerance. * pregnant women.

Keywords: antibiotic ultrasound efficacy treatment
activity monitoring in pulmonary hypertension

Conditions: Pulmonary Hypertension

Summary: this is a prospective, longitudinal, observational study of free-living activity trackers and patient reported outcomes to test the hypothesis that daily activity will have stronger prognostic value than 6mwd in patients with pulmonary hypertension after 12 weeks.

a prospective, longitudinal, observational study of free-living activity tracking and patient-reported outcomes in patients with pulmonary hypertension. participants will undergo activity monitoring for 12 weeks once a year for 4 years. patient-reported outcomes will be collected including quality of life (emphasis-10, minnesota living with heart failure (mlhf), and sf-36 surveys), medication changes, hospitalization, and death. this study aims to enroll 500 participants. the objectives of this study are to establish the clinical utility of daily activity tracking in patients with pulmonary hypertension and to identify clinical factors associated with reduced daily activity.

Eligibility criteria:
inclusion criteria: * enrolled in l-pvdomics or * any patient in the united states with pulmonary hypertension confirmed by hemodynamics and expert clinical diagnosis exclusion criteria: * pregnancy * hospitalization within the prior 3 months * orthopedic limitations that preclude 6mwd testing

Keywords: pulmonary hypertension