Kornimate/medical-research-clean huggingface dataset:
a study of poziotinib in combination with t-dm1 in her2-positive breast cancer

Conditions: Breast Cancer

Summary: this is a phase 1b, open-label, multicenter study to determine the maximum tolerated dose (mtd) or maximum administered dose (mad) of poziotinib when administered with standard dosing of t-dm1 (3.6 mg/kg iv on day 1 of each 21-day cycle) in women with advanced or metastatic her2+ breast cancer. the poziotinib dose identified in part 1 of the study will be used in combination with standard dose of t-dm1 in part 2 of the study to confirm the poziotinib dose and evaluate the preliminary efficacy of the combination therapy.

in part 1, the dose of poziotinib, in combination with the standard dose of t-dm1 (3.6 mg/kg iv) on day 1 of each cycle will be determined using a "3+3" design with up to 3 dose levels tested beginning with 8 mg/day. poziotinib dose escalation/de-escalation for the next dose cohort will proceed based on the occurrence of dose-limiting toxicities (dlts) during cycle 1 of the dose cohort. patients in the dose cohort, if not discontinued, will continue treatment until discontinuation. in part 2 of the study, approximately 10 patients will be treated at the mtd/mad to confirm dose for safety of the combination and to evaluate preliminary efficacy. treatment for all patients will continue until disease progression, unacceptable toxicity, or continuation of study treatment is not in the best interest of the patient. the screening period (day -30 to day -1) will last up to 30 days prior to cycle 1, day 1. during each 21-day cycle, eligible patients will receive poziotinib at the assigned dose, orally, once daily. t-dm1 3.6 mg/kg iv will be administered on day 1 of each treatment cycle. all treated patients will be followed for response until disease progression or the start of new treatment and then for survival (3 year study duration).

Eligibility criteria:
inclusion criteria: * patient must be female, at least 18 years of age, but not older than 90 years, with advanced or metastatic her2+ breast cancer and a life expectancy of more than 6 months * patient must have confirmed her2 overexpression or gene-amplified tumor via immunohistochemistry \[ihc\] with ihc 3+ or ihc 2+ with confirmatory fluorescence in situ hybridization \[fish\]+ or \[ish\]+ * patients must have had at least 1 line of anti-her2 directed therapy either in the metastatic or early-stage disease setting * eastern cooperative oncology group (ecog) performance status 0 or 1 exclusion criteria: * patient has had previous treatment with poziotinib. * patient has received anticancer chemotherapy, tkis, biologics, immunotherapy, radiotherapy, or investigational treatment within 15 days. (there is no washout for hormonal therapy for breast cancer). * patient has a life expectancy less than 3 years due to other malignancies. * patient is pregnant or breast-feeding.

Keywords: poziotinib her2 positive t-dm1
impact of local anesthetic volume during ultrasound-guided stellate ganglion block

Conditions: Neuropathic Pain

Summary: the purpose of this study was to compare the temperature changes of the upper extremities when using local anesthetic of various volume (4ml, 6ml, 8ml) in the ultrasound guided stellate ganglion block.

one pain physician performs all us-guided stellate ganglion block(sgb)s, who is not involved in evaluating study variables. electrocardiography, noninvasive blood pressure, heart rate, and peripheral oxygen saturation were monitored for all patients before, while, and after conducting procedure. for us-guided sgb, patients are supine positioned, and skin preparation on injection site is done with chlorohexidine. procedure is conducted under ultrasound guidance at c6 level. 4ml, 6ml, and 8ml of 1% lidocaine is injected for the each group, respectively. syringes are prepared by one nurse who do not involved in other steps of this study. temperature measurement is conducted 4 times (before us-guided sgb and after 10, 20, and 30m from sgb) at both hands, face, axillar by one person who's not involved in other measuring in the study.

Eligibility criteria:
inclusion criteria: * patients aged 18 to 85 years * patients with a new or known diagnosis of chronic neuropathic pain at the upper extremity or face. exclusion criteria: * refusal of a patient * any vascular disease in the upper extremities (or face) * previous history of thoracic sympathetic or stellate ganglion neurolysis (e.g. thermocoagulation, radiofrequency neuromodulation, and/or chemical neurolysis) * coagulopathy * systemic infection or local infection at the needle injection site * major deformation at the level of the neck (radiotherapy, surgery, etc.) * concomitant chronic pain syndrome at other sites. * post-pneumonectomy on the controlateral side * known allergy to local anesthetics of amide type * inability to understand a numeric rating pain scale (cognitive dysfunction)
longitudinal assessment of adults with severe asthma

Conditions: Asthma

Summary: cross-sectional study to characterize cohorts of subjects with asthma and healthy controls in terms of clinical features, physiological measurements and non-invasive measurement of biomarkers and develop phenotype handprints for adults with severe asthma


Eligibility criteria:
general inclusion criteria: 1. able to give written informed consent prior to participation in the study, which includes ability to comply with the requirements and restrictions listed in the consent form. informed consent must be obtained prior to undertaking any study procedures. 2. male or female subject aged 18 years or older at screening. 3. able to complete the study and all measurements. 4. able to read, comprehend, and write at a sufficient level to complete study related materials. 5. subjects will be allowed to enrol in other studies while taking part on this study. however, permission from the scientific board must be obtained to enrol or allow the continued participation of a subject enrolled in another study. general exclusion criteria: 1. as a result of medical interview, physical examination or screening investigation the physician responsible considers the subject unfit for the study either because of the risk to the subject due to the study or the influence this may have on the study results. 2. the subject has a history of recreational drug use or other allergy, which, in the opinion of the responsible physician, contra-indicates their participation. 3. subject is female who is pregnant or lactating or up to 6 weeks post partum or 6 weeks cessation of breast feeding. if a woman is subsequently found to have been pregnant at the time of an assessment data from that assessment will not be included in the analyses. 4. the subject has participated within 3 months of the first dose in a study using a new molecular entity, or the first dose in any other study investigating drugs or having participated within three months in a study with invasive procedures. any u-biopred assessments should be deferred until 3 months after the first dose or invasive procedure. permission from the scientific board must be obtained to enroll or allow the continued participation of a subject enrolled in another study. 5. those who, in the opinion of the investigator, have a risk of non-compliance with study procedures. 6. the subject has a recent history of incapacitating psychiatric disorders 7. history or current evidence of an upper or lower respiratory infection or symptoms (including common cold) within 2 weeks of baseline assessments (assessments should be deferred).

Keywords: sputum clinical cohorts smokers asthma biopsies severe asthma collaborative research phenotyping lipidomics transcriptomics proteomics paediatric cohort systems biology
sling suspension versus gym balls in the treatment of juvenile spinal osteochondrosis

Conditions: Juvenile Osteochondrosis of Spine

Summary: this study compares effect of swiss ball exercises with sling suspension exercises in the treatment of juvenile osteochondrosis in adolescent-girls

one of the main tasks in the treatment of osteochondrosis related back pain is training trunk stabilizing muscles. this might be achieved by using a sling suspension exercise systems. redcord is a trademark for sling exercise therapy. suspension exercise training has been shown to improves functional movement patterns more effectively than traditional exercise by creating a challenging and pain free environment for movement re-training. another commonly used option in the treatment of juvenile osteochondrosis is gymball, also known as swissball core training programmes that are popular trends in physiotherapy and strength and conditioning programs. benefits of gymball core training exercises that facilitate spinal stability and balance have often been emphasized by researchers in development of strength and endurance, flexibility, and neuromuscular control as a cost effective and enjoyable way to treat and prevent back pain. both exercises modes are used in treatment of back pain and muscle training in young people with juvenile osteochondrosis, what is why this study aims to compare sling suspension therapy with gymball exercise in this population.

Eligibility criteria:
inclusion criteria: * diagnosis - juvenile osteochondrosis (according to the international classification of diseases - icd m 42 gender: female exclusion criteria: * any other medical diagnosis

Keywords: back pain suspension therapy gymball standing posture muscle endurance
68ga-p16-093 and 68ga-psma-617 pet/ct imaging in the same group of prostate cancer patients

Conditions: Prostate Cancer

Summary: prostate-specific membrane antigen (psma)-targeted pet imaging with 68ga-labeled compounds is able to provide superior sensitivity and specificity to detect primary prostate tumor and its metastases, like the widely studied 68ga-psma-617. this pilot study was prospectively designed to evaluate the early dynamic distribution of 68ga-p16-093, a novel radiopharmaceutical targeting psma, which was compared with 68ga-psma-617 in the same group of prostate cancer patients.

prostate cancer (pc) is one of the most common malignancies worldwide in men, with persistently high numbers dying from this disease. due to low levels of glycolysis in prostate cancer cell, the uses of 18f-fdg pet/ct to detect prostate cancer and its metastases are limited. prostate specific membrane antigen (psma), as known as folate hydrolase i or glutamate carboxypeptidase ii, is overexpressed on the cells of prostatic adenocarcinoma. various low molecular weight radiopharmaceuticals targeting psma such as psma-617, psma-11 for 68ga-labeling have been developed. 68ga-psma pet/ct has demonstrated desirable sensitivity and specificity in the detection of prostate cancer lesions, which can find many micro lesions that cannot be identified by ct, mri and bone scan. 68ga-p16-093, a novel radiopharmaceutical targeting psma, with the urea fragment of a conjugate that employs the hbed-cc chelator for labeling with 68ga(iii). the hbed-based chelating ligand binds the 68ga3+ ion with high affinity in a pseudo-octahedral n2o4 coordination sphere by its two phenolate o, two amino-acetate carboxylate o, and two amino n donor atoms. mark a. green et.al had demonstrated that 68ga-p16-093 provided diagnostic information that appeared equivalent to 68ga-psma-11 in prostate cancer patients presenting with biochemical recurrence, and 68ga-p16-093 exhibits less urinary excretion than observed for 68ga-psma-11. this pilot study was prospectively designed to evaluate the early dynamic distribution of 68ga-p16-093 compared with 68ga-psma-617 in the same group of prostate cancer patients.

Eligibility criteria:
inclusion criteria: * confirmed treated or untreated prostate cancer patients; * 68ga-psma617 and 68ga-p16-093 pet/ct within two consecutive days; * signed written consent. exclusion criteria: * known allergy against psma; * any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
effect of fecal capsule on chronic kidney disease (ckd)

Conditions: Renal Insufficiency, Chronic

Summary: by collecting blood, urine and stool samples before and after oral enterobacteriaceae capsule (fmt) from ckd subjects, we investigated the role and related mechanisms of gut microecology in the development of ckd using a combination of metagenomic sequencing, metabolomic analysis and flow cytometry.

patients involved in the trial received 16 capsules of enterobacteriaceae (one course) on days 1, 8, and 15, which were provided by dongyuan yikang company. patients were prohibited from taking antibiotics such as amoxicillin and cefalexin during the trial.

Eligibility criteria:
inclusion criteria: 1. subjects: patients with chronic kidney disease (ckd) 2. gfr ≥ 30 ml / min, or serum creatinine ≤ 442 μ mol/l 3. negative urine pregnancy test and no plans for pregnancy for the next 18 months, enabling effective contraception 4. age: 18-70 years 5. signed informed consent for clinical studies informed consent for treatment of patients with flora transplantation (fmt) exclusion criteria: 1. had taken antibiotics for nearly 14 days 2. active systemic infections or severe infections within 1 month prior to enrollment, including hiv, hbv, hcv 3. white blood cell count \< 3.0x109/l; platelet count \< 80x109 / l, or had other hematologic diseases 4. presence of malignancy and other diseases with expected survival time \< 3 months 5. presence of ibd, cdi, or gastrointestinal tumors 6. presence of active gastrointestinal bleeding or acute and chronic gastrointestinal inflammation 7. were or had undergone fmt 8. psychosis and cognitive impairment 9. history of alcohol or drug abuse 10. pregnant or lactating women 11. difficult to follow-up 12. difficult or unwilling to cooperate
risk evaluation and education for alzheimer's disease (reveal) iv

Conditions: Mild Cognitive Impairment

Summary: this study is intended to examine the impact of receiving a genetic risk assessment for alzheimer's disease (ad) among individuals with mild cognitive impairment (mci).

alzheimer's disease is a common condition affecting memory and thinking. genes can sometimes be used to provide risk estimates for the eventual development of certain common diseases. apolipoprotein e (apoe) is one gene which can provide information about a person's chances of developing alzheimer's disease. some people with a diagnosis of mild cognitive impairment (mci) are curious to learn more about the chance of developing alzheimer's disease. in the reveal iv study, we are examining the psychological and behavioral impact of learning genetic risk information pertaining to the chance for an individual with mci to progress to dementia of the alzheimer's type within three years. participation in this study requires an initial phone call which will elicit some demographic information about the participant and his or her study partner. a first in-person visit to the research clinic will consist of an education session, the administration of knowledge and attitudinal surveys and some tests to assess memory and thinking skills. this visit will take approximately 2-3 hours. participants with mci will have their blood drawn for genetic testing. participants will then be randomized to one of two groups. those in the intervention arm will receive a three-year risk estimate for the chance of progressing to dementia of the alzheimer's type based on age, the diagnosis of mci and their own apoe gene test result. those in the comparison arm will receive a three-year risk estimate for the chance of progressing to dementia of the alzheimer's type based on age and the diagnosis of mci, without the apoe gene test result. participants randomized to the comparison arm will have the opportunity to learn their own apoe gene test result at the end of the study. participants and their study partners will be followed for 6 months following disclosure of results with 1 additional clinic visit and 1 additional phone interviews.

Eligibility criteria:
inclusion criteria: * individuals (55-90 years old) with mild cognitive impairment (amnestic-mci as defined by the petersen criteria) * individuals who have a close friend, relative or spouse (18+) willing to be a study partner. study partners attend each study visit with the participant and also complete surveys and interviews. exclusion criteria: * individuals with current, untreated anxiety or depression * individuals who do not meet the criteria for amnestic-mci * individuals who have the diagnosis of dementia or alzheimer's disease * individuals not fluent in english * individuals who do not have a study partner

Keywords: mild cognitive impairment (mci) alzheimer's disease (ad) apoe genetics risk assessment education genetic counseling mild cognitive impairment, so stated
deep brain stimulation for patients with parkinson's disease.

Conditions: Parkinson Disease

Summary: deep brain stimulation of the sub thalamic nucleus (stn-dbs) is an efficient treatment to improve motor and non motor signs of parkinson's disease (pd). in people aged more 70 years, an increased rate of side effects such as post-operative cognitive decline and/or postural instability with falls has been suspected with less improvement in the quality of life. here, investigators aim further explore the effects of stn-dbs in 50 patients with pd people aged more 69 years in a randomized parallel controlled study.

the effects of combined bilateral deep brain stimulation of the subthalamic nucleus and medical treatment on the quality of life will be evaluated in 25 pd patients aged more 69 years in comparison to 25 pd patients aged more 69 years that only received medical drug treatment.

Eligibility criteria:
inclusion criteria: * parkinson's disease * disease duration \> 5 years * levodopa related motor complications * dopasensitivity \> 50% * signed informed written consent * medical social insurance exclusion criteria: * dementia * contra-indication to neurosurgery
tear concentrations and pharmacokinetics of azithromycin eye drops in healthy volunteers

Conditions: Pharmacokinetics

Summary: to evaluate azithromycin tear concentrations after one drop of azithromycin eyedrops (2.5ml/25mg) in healthy volunteers.

in this randomized, open, single-center study, 42 healthy volunteers will receive one drop of azithromycin into each eye. azithromycin tear concentrations will be measured by lc-ms/ms at seven time points for 24 hours. tolerability is evaluated.

Eligibility criteria:
inclusion criteria: * 18 to 45 years old, male or female; * bmi in the range of 19 to 24; * eyes corrected visual acuity should be ≥ 1.0, intraocular pressure, slit lamp and fundus examination were normal, tear secretion function is normal; * good compliance and voluntarily signed consent. exclusion criteria: * have eye disease or systemic disease; * physical examination, laboratory tests, ecg and chest x-ray examination abnormalities and has clinical significance; * hbsag, anti-hcv, anti-hiv and tppa positive; * those who used eye drops two weeks before the test and who used any dosage form of azithromycin; * known to azithromycin or macrolide-related varieties of allergies or serious adverse reactions; * need to wear contact lenses during the test; * history of internal surgery or laser surgery history; * participated in other drug clinical trials in the past three months; * pregnant women and lactating women, or in the growth period without taking effective contraceptive measures, menstrual period women; * mental illness or alcohol, history of drug abuse or inability to collaborate; * any other circumstances that the investigators consider are unfit to participate in this study.

Keywords: azithromycin eyedrops, pharmacokinetics, tears
the effect of centella asiatica cream on scar tenderness who underwent open carpal tunnel release surgery

Conditions: To Prevent Scar Formation for Patients Underwent Surgery

Summary: the centella asiatica cream applied to the wrist after the ctr surgery was found to be beneficial in preventing the scar tenderness in the thenar and hypothenar regions of the hand.

aim: this study was performed to evaluate the efficacy of centella asiatica extract in a cream preparation for the prevention of scar tenderness formation in patients who underwent conventional open carpal tunnel release surgery.

Eligibility criteria:
inclusion criteria: patient underwent open carpal tunnel release surgery - exclusion criteria:before hand surgery and recurrent carpal tunnel release surgery. -

Keywords: carpal tunnel syndrome centella asiatica surgery cosmetic outcome wound healing
a safety and efficacy study of vi-0521 to evaluate the long term treatment of obesity in adults with obesity-related co-morbid conditions. an extension study of protocol ob-303 (nct00553787)

Conditions: Obesity

Summary: the purpose of this study is to evaluate the long-term safety and efficacy of vi-0521 compared to placebo for the treatment of overweight and obesity in adults who have completed study ob-303 (nct00553787) at selected study sites. this is an extension study of protocol ob-303 (nct00553787).


Eligibility criteria:
inclusion criteria: to be eligible for enrollment into this study, subjects must meet all of the following criteria: * completion of study ob-303 (nct00553787) on treatment and compliance with all protocol requirements * written informed consent * female subjects of childbearing potential must be using adequate contraception, defined as double-barrier methods, stable hormonal contraception plus single barrier method, or tubal ligation. female subjects are considered to be of childbearing potential unless they have undergone a hysterectomy or bilateral oophorectomy, are ≥55 years of age and experienced spontaneous cessation of menses for at least 1 year, or have a documented follicle-stimulating hormone level ≥40 iu/l * willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. exclusion criteria: subjects will not be included in the study if they meet any of the following: * body mass index ≤22 kg/m2 at the completion of study ob-303 * off study medication at completion of study ob-303 (nct00553787) for longer than 4 weeks continuously due to an event-driven holiday, or off study medication with no plans to restart * development of any condition during study ob-303 (nct00553787) that, in the opinion of the investigator, would contraindicate the administration of study medication, affect compliance, interfere with study evaluations, or confound the interpretation of study results * participation in a formal weight loss program (including: weight watchers and related dietary/lifestyle intervention programs; prepared food programs; prescribed or over the counter weight loss medications; dietary supplement or herbal preparations, teas, or tinctures intended for weight loss; or any supervised fast or very low calorie diet).

Keywords: obesity