Kornimate/medical-research-clean huggingface dataset:
a study of zen003694 in patients with metastatic castration-resistant prostate cancer

Conditions: Metastatic Castration-Resistant Prostate Cancer

Summary: this is an open label, phase 1, dose escalation and dose confirmation study of zen003694 in patients with mcrpc.


Eligibility criteria:
inclusion criteria: 1. males age ≥ 18 years 2. metastatic, castrate resistant, histologically confirmed prostate cancer; surgically castrated or continuous medical castration for ≥ 8 weeks prior to screening 3. serum testosterone \< 50 ng/dl determined within 4 weeks of first administration of study drug 4. prior progression on one or more androgen-receptor/androgen-synthesis inhibitor therapies (e.g. abiraterone, enzalutamide, apalutamide, tak-700 and/or galeterone) by prostate cancer working group 2 (pcwg2) criteria. prior progression on bicalutamide/nilutamide/flutamide/ketoconazole alone is not allowed. 5. eastern cooperative oncology group (ecog) performance status of 0 or 1 6. adequate laboratory parameters \[absolute neutrophil (anc), platelets, aspartate aminotransferase (ast), alanine aminotransferase (alt), total bilirubin, creatinine and coagulation parameters\] at screening exclusion criteria: 1. any history of brain metastases or prior seizure or conditions predisposing to seizure activity 2. have previously received an investigational bet inhibitor (including previous participation in this study or study zen003694-002) 3. have received prior systemic anti-cancer therapy or investigational therapy within 2 weeks or five half-lives, whichever is shorter, prior to the first administration of study drug 4. failure to recover to grade 1 or lower toxicity related to prior systemic therapy (excluding alopecia and neuropathy) prior to study entry 5. radiation therapy within 2 weeks of first administration of study drug 6. have received prior chemotherapy in the metastatic castration-resistant setting (prior chemotherapy in the hormone-sensitive setting is allowed provided last dose was at least 6 months prior to study entry) 7. currently receiving medications known to be strong inducers or inhibitors of cyp3a4 with a narrow therapeutic window. strong inducers and inhibitors of cyp3a4 with narrow therapeutic ranges must be discontinued at least 7 days prior to the first administration of study drug.

Keywords: metastatic castration-resistant prostate cancer (mcrpc) phase 1 prostate cancer pharmacokinetics (pk) zen003694 zen-3694 metastatic castrate-resistant prostate cancer bet inhibitor (beti) bromodomain pharmacodynamics (pd) epigenetics
hypofractionated radiotherapy for limited stage small cell lung cancer

Conditions: Lung Neoplasm; Small Cell Carcinoma

Summary: it is accepted that giving higher doses of chest radiation in as short a time span as possible improves chances of cure. in this study, the investigators propose to give an increased dose of chest radiotherapy for limited stage small cell lung cancer patients using a strategy of giving a slightly higher daily dose of radiotherapy than normal. the investigators hypothesize that our proposed chest radiotherapy dose will improve 2-year overall survival rates in patients with limited stage small cell lung cancer.

the ideal chest radiotherapy dose/fractionation scheme for limited stage small cell lung cancer is undefined. strategies of radiotherapy dose intensification with minimization of overall treatment time are felt to improve cure rates for ls-sclc. hypofractionation (giving higher than standard daily doses) facilitates both of these goals. in this study, we propose to use a dose escalated hypofractionated regimen of chest radiotherapy for patients with ls-sclc.

Eligibility criteria:
inclusion criteria: * limited stage small cell lung cancer * adequate pulmonary function test (fev1 \>1.0 l, dlco \>50%) * signed study consent * age at least 18 years * karnofsky performance status as least 70% * eligible to receive standard concurrent small cell cancer chemotherapy exclusion criteria: * extensive stage disease * mixed non small cell and small cell histology * inadequate pulmonary function tests * not eligible for concurrent chemotherapy * subtotal or total tumor resection * previous chest/neck radiotherapy * prior or concurrent malignancy except non-melanomatous skin unless disease free for last 5 years * pregnant * prior chemotherapy for another malignancy * patients with myocardial infarction within the preceding 6 months of symptomatic heart disease, including, angina, congestive heart failure, uncontrolled arrhythmias

Keywords: small cell lung cancer radiotherapy dose escalation
effects of natural sounds on attention restoration in virtual reality

Conditions: Cognitive Fatigue; Mental Fatigue; Behavioral Performance; Heart Rate Variability; Working Memory

Summary: this study aims to examine whether listening to natural sounds in a noisy virtual reality environment compared to no natural sounds influences physiological markers.

the investigators hypothesize that listening to natural sounds has restorative effects on attention by supporting greater use of involuntary attention. this generates the prediction that exposure to natural sounds in the context of a noisy environment will have greater restorative effects on attention (i.e., physiological) as compared to the control group (exposed to noise only). individual differences (i.e., age, gender, caffeine and food intake, body mass index, skin temperature, noise sensitivity, sleep quality, baseline physiology and behavioural performance) will be examined and accounted for.

Eligibility criteria:
inclusion criteria: * singapore-based * non-clinical * 18-35years exclusion criteria: * individuals with hearing difficulties or failing to meet the minimal threshold for normal hearing * individuals with a history of ear, developmental, neurological, or psychiatric disorder
mandibular stability and dentofacial deformity

Conditions: Maxillofacial Abnormalities

Summary: the present study intends to clarify whether there is positional mandibular stability in patients to be submitted to orthognathic surgery. in case of any instability exists, it is needed to understand if this could be related to a particular type of dentofacial deformity or could have any short-term or long-term influence on outcomes of the orthognathic surgery.

treatment of skeletal discrepancy nowadays is mainly performed by combination of clinical and surgical procedures in which orthodontics intends to align the teeth according to their respective alveolar bone and the surgical procedure - orthognathic surgery - realign the jaws in an adequate position among themselves and related to the rest of the craniofacial skeleton. orthognathic surgery has developed throughout the years technically as well as regarding fixation devices for the operated segments, providing prediction of results with a low complication incidence. a debate point is related to the possible instability of the mandibular position as a reference for surgical planning due to its articulation with the temporal fossa, the temporomandibular joint. however, studies have shown that not always the mandible position obtained for the articulator reflects the position observed in subjects after induction of general anesthesia. since there is no evidence that indicates that any alteration of the position of the mandible could influence the outcomes of a orthognathic surgery nor any relationship of a certain type of dentofacial deformity that would be beneficiated by an specific order of surgery or skeletal reference (maxilla or mandible), the present study intends to clarify some of these questions.

Eligibility criteria:
inclusion criteria: * dentofacial deformity candidate to orthognathic surgery; * systemically capable to be submitted to the orthognathic surgery. exclusion criteria: * patient's health condition is not stable enough to guarantee uneventful outcome; * required data unable to be achieved; * patient not agreeing to participate to the study.

Keywords: dentofacial deformity orthognathic surgery mandible orthognathic surgical procedures
internet-based intervention to promote a healthy lifestyle on the reproductive parameters of overweight and obese women

Conditions: Obesity; Infertility, Female

Summary: obesity and overweight are among the problems that produce infertility. the combination of diet and exercise to achieve weight loss are currently considered an effective intervention for the improvement of reproductive parameters in overweight or obese infertile women. aim: to evaluate the effectiveness of an online program to promote a healthy lifestyle among women who are overweight or obese who also have a diagnosis of infertility and are on the waiting list for in vitro fertilisation treatment

weight management problems (being obese or overweight) are among the problems that produce infertility. the combination of diet and exercise to achieve weight loss are currently considered an effective intervention for the improvement of reproductive parameters in overweight or obese infertile women. aim: to evaluate the effectiveness of a 3-month internet-based program focusing on the promotion of healthy lifestyles (especially weight loss and healthy eating and physical exercise habits) in women who also have a diagnosis of infertility and are on the waiting list for ivf treatment. design: randomised controlled trial setting: hospital la plana (villarreal)

Eligibility criteria:
inclusion criteria: * women of childbearing age * overweight (bmi \> 25 kg/m2) or obese (bmi \> 30 kg/m2) * diagnosed with primary infertility -access to the internet- exclusion criteria: * over 40 years * morbid or extreme obesity (bmi \> 40 kg/m2) * bilateral obstruction of the fallopian tubes * endometriosis * women whose partner has a severe male factor (oligoasthenoteratozoospermia).

Keywords: infertility obesity physical activity nutrition internet
water induced thermogenesis in obese children

Conditions: Obesity

Summary: drinking water is largely advocated for obesity prevention and management. recent studies have suggested that water has a thermogenic effect, this has not been examined in children. in this study, we will measure the resting metabolic rate of 21 obese children before, and during drinking cold (4 degrees centigrade)water for up to 60 minutes.


Eligibility criteria:
inclusion criteria: * obesity * agreement and informed consent exclusion criteria: * non-agreement

Keywords: resting metabolic rate
double-dose ranibizumab for polypoidal choroidal vasculopathy

Conditions: Polypoidal Choroidal Vasculopathy

Summary: the purpose of this study is to determine whether double-dose ranibizumab are effective to regress the polyps and benefit to the visual outcome in the polypoidal choroidal vasculopathy (pcv).

recently, it's reported that intravitreal high dose lucentis®（ranibizumab） could benefit to both regression of the polyps and the relief of macular edema in pcv patients. since it was a single arm prospective study with a relatively small sample size, randomized clinical trials were needed to confirm the efficacy of high dose ranibizumab in pcv treatment. in this study, the investigator will compare the efficacy of double-dose (1mg, 3+prn) raibizumab with regular dose (0.5mg, 3+prn) for pcv treatment.

Eligibility criteria:
inclusion criteria: * age ≥ 50 years and ≤80; * active pcv confirmed by icga+ffa (indocyanine green angiography + fundus fluorescein angiography); * at least one distinguishable polyp was shown in icga; * bcva between 24 to 73 letters with etdrs chart (early treatment of diabetic retinopathty study); * the greatest linear dimension of the lesion \<5400μm. exclusion criteria: * previously received treatment of laser retina photocoagulation, transpupillary thermotherapy, pneumatic displacement of subretinal blood or any investigational treatment; * previous photodynamic therapy or anti-vegf treatment within 6 months in study eye * previously received treatment of photodynamic treatment within 1 month, or any anti-vascular endothelial growth factor (vegf) intraocular injection in 3 months in the fellow eye; * combine of current vitreous hemorrhage or extensive subretinal hemorrhage (lesion area \>30mm2); * a history of angioid streaks, presumed ocular histoplasmosis syndrome or pathologic myopia; * experienced retinal pigmental epithelium (rpe) tear, retinal detachment, macular hole or uncontrolled glaucoma; * undergone intraocular surgery (except uncomplicated cataract extraction with intraocular lens implantation); * cataract extraction with intraocular lens implantation within 60 days; * combine of cataract that could require medical or surgical intervention during 12 months; * combine of diabetes mellitus and have poor glucose control (haemoglobin a1c (hba1c) \>8%); * combine of hypertension and have poor blood pressure control (blood pressure ≥140/95 mmhg after regular antihypertensive drugs treatment); * history of myocardial infarction or cerebral infarction in last 6 months; * during gestation period or lactation period; * combine of confirmed systemic autoimmune disease or any uncontrollable clinical conditions (e.g. hiv, malignant tumor, active hepatitis, severe systemic disease, diseases need immediately surgical treatment).

Keywords: ranibizumab, regression of the polyps
ada linagliptin in long term care

Conditions: Diabetes

Summary: this is a study to determine whether glycemic control, as measured by change in hba1c and frequency of hypoglycemia, is different between treatment with linagliptin (tradjenta®) and basal insulin in long term care residents(ltc) with type 2 diabetes(t2d). patients with poorly controlled diabetes (hba1c \>7.5%) will be randomized to a 6-month intervention with linagliptin or glargine insulin (± metformin for both treatments). our hypothesis is that treatment with linagliptin, a once daily dpp4-inhibitor, will result in similar improvement in glucose control but in a lower rate of hypoglycemia than insulin treatment in ltc residents with t2d. we will also determine differences in clinical outcome, resource utilization, and hospitalization costs between ltc residents with t2d treated with linagliptin and basal and correction insulin. we will compare differences in complications (infectious and non-infectious, neurological and cardiovascular events), emergency room visits and hospitalizations between groups during the 6 months of intervention.


Eligibility criteria:
inclusion criteria: 1. males or females with known history of type 2 diabetes, treated with diet, oads as monotherapy or in combination therapy (excluding dpp4 inhibitors), or sliding scale insulin. 2. subjects with hba1c \> 7.5% and/or any blood glucose greater than or equal to 180 mg/dl exclusion criteria: 1. subjects with a history of type 1 diabetes or with a history of diabetic ketoacidosis 2. treatment with insulin or glp1 analogs during the past 3 months prior to admission. 3. recurrent severe hypoglycemia or hypoglycemic unawareness. 4. subjects with history of gastrointestinal obstruction or gastroparesis. 5. patients with acute or chronic pancreatitis or pancreatic cancer. 6. patients with clinically significant hepatic disease (cirrhosis, jaundice, end-stage liver disease, portal hypertension) and elevated alt and ast \> 3 times upper limit of normal, or significantly impaired renal function (gfr \< 45 ml/min). 7. treatment with corticosteroids, parenteral nutrition and immunosuppressive treatment. 8. mental condition rendering the subject unable to understand the nature and scope of the study.

Keywords: nursing home facility long-term care facility older patients elderly patients hyperglycemia type 2 diabetes
oxidative stress and mitochondrial tert in papillary thyroid cancer.

Conditions: Papillary Thyroid Cancer

Summary: oxidative stress (os) could be involved in the progression of papillary thyroid cancer (ptc). indeed, thyroid differentiation genes are silenced by a mechanism controlled by nox4-derived os. on the other hand, tert contributes to mitochondrial os protection, which could increase the resistance of cancer cells to therapeutic agents. the investigators aim to address the role of os and mitochondrial tert in the progression and therapeutic resistance of ptc. os and tert subcellular localization will be investigated in 150 ptcs and correlated to the genetic and expression profile of the tumors and to the clinical and prognostic features of the patients. mechanisms implicated in tert mitochondrial migration and the contribution of mitochondrial tert to tumor progression will be investigated in cancer cell lines and primary cell cultures. this study will allow to identify os as a marker of therapeutic resistance in ptc and will open new opportunities for the development of novel treatments targeting ros generation/tert nuclear export.


Eligibility criteria:
inclusion criteria: * patients with papillary thyroid cancer * patients whose tumor and contralateral healthy tissues can be collected for the analyses exclusion criteria: * patients who did not provide consent * patients lost at follow-up * tissues not adequate for the analyses
responses induced by smoking in individuals being susceptible and non-susceptible for development of copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: copd is ranked number 3 by the who list of important diseases worldwide and is the only disease with increasing mortality. the pathogenesis of cigarette smoke-induced copd is obscure, therefore more insight is needed to design effective anti-inflammatory agents. we hypothesize that healthy individuals who are susceptible to smoking demonstrate a higher and aberrant inflammatory response to cigarette smoke. this susceptibility is caused by heterogeneous factors and is associated with various polymorphic genes that interact with each other and with the environment. objective: * to define mediators involved in the early induction of copd in susceptible smokers (and so to define new drug targets) * to develop new biological and clinical markers for the early diagnosis and monitoring of copd * to compare between susceptible and non-susceptible individuals the corticosteroid responsiveness of bronchial epithelial cells in vitro, and to study the mechanisms of smoking-induced corticosteroid unresponsiveness. * to study the role of candidate genes that may play a role in the development of fixed airway obstruction, and to identify clues for patient's responsiveness to specific drugs.

primary study parameters/outcome of the study: * local inflammation before and after cigarette smoking assessed by exhaled breath condensate, microprobe sampling and bronchial biopsies. * systemic inflammation before and after cigarette smoking assessed by the expression of established and newly developed markers on innate immune cells associated with pre-activation. * extensive clinical characterisation including life style factors, lung function, ct scanning of the lung. * corticosteroid responsiveness of epithelial cells in vitro. * distribution of candidate genes (snps) for copd between the 5 different groups ( see description below) and associations with the inflammatory responses on acute smoking.

Eligibility criteria:
inclusion criteria: * age 18-75 years * age, pack years, fev1/fvc and fev1% predicted must fit in one of the 5 groups described above. * able to stop smoking for 10 days and start smoking 3-4 cigarettes within 1 hour * physically and mentally able to undergo the total study protocol * written informed consent exclusion criteria: * participation in another study * alpha-1-antitrypsin deficiency * selected grade 1-3 co-morbidity listed in the ace-27 * active pulmonary infection like tuberculosis, pneumonia, flue, tracheobronchitis * active extra-pulmonary infection like hepatitis a-c, cystitis, gastro-enteritis etc * pulmonary diseases like sarcoidosis, ipf, silicosis, hypersensitivity pneumonitis * life threatening diseases like carcinoma, aids (including hiv+), acute leukaemia etc * medication that may affect the results of the study: nsaid's, immunosuppressive agents like prednisolon, metotrexate, azathioprine,acenocoumarol

Keywords: copd smoking susceptibility inflammation genetic
24 hour iop lowering efficacy of al-3789

Conditions: Open-angle Glaucoma

Summary: the objective of this study was to describe the intraocular pressure-lowering efficacy of al-3789 over a 24-hour period in patients with open-angle glaucoma compared to an untreated control. patients received one treatment of al-3789. twenty-eight days after treatment, iop was measured every 4 hours, beginning at 8 am for 24 hours.


Eligibility criteria:
inclusion criteria: * diagnosis of open-angle glaucoma and treated for at least 30 days prior to screening visit with a topical prostaglandin analog as monotherapy. * other protocol-defined inclusion criteria may apply. exclusion criteria: * pregnant, intend to become pregnant, breastfeeding. * difference in iop greater than 3 mm hg between eyes at screening visit. * any form of glaucoma other than open-angle glaucoma. * other protocol-defined exclusion criteria may apply.
serial comparisons of abdominal and neurological mri scans

Conditions: Psychotic Disorders

Summary: the purpose of this study is to compare abdominal weight gain and fat distribution to changes in brain morphology in people taking antipsychotic medications.

abdominal weight gain is a significant side effect of antipsychotic medications. it has even been suggested to be part of the pathology of severe mental illnesses. studies have shown that in persons with bipolar disorder, increased body mass index (bmi) is associated with irregular changes in the brain. this association has not been tested in persons with psychosis. in this study, we will be measuring abdominal fat distribution as measured by mri to see if this is associated with abnormal brain morphology.

Eligibility criteria:
inclusion criteria: * must be admitted to the bc (british columbia) psychosis program at ubc (university of british columbia) hospital * must have clinically diagnosed psychosis (e.g. schizophrenia) * must be fluent in english * must not be contraindicated for mri (i.e., must not be claustrophobic, have metal in the body, be pregnant, have bmi greater than or equal to 40, etc.) exclusion criteria: • none, other than those listed above

Keywords: psychosis adverse effects symptom severity magnetic resonance imaging
acetabular cerclage and total hip arthroplasty in the treatment of acetabular fractures in elderly patients.

Conditions: Elderly; Acetabular Fractures; Cerclage Acetabular Fractures; Total Hip Arthroplasty

Summary: we want to present the outcome of complex multifragmented acetabular fractures in the elderly treated with acetabular cerclage and total hip arthroplasty.


Eligibility criteria:
inclusion criteria: * elderly (\>60years) * acetabular fracture exclusion criteria: * revision surgery