Kornimate/medical-research-clean huggingface dataset:
provide expanded access to mdv3100 and monitor its safety in patients with progressive castration-resistant prostate cancer previously treated with docetaxel-based chemotherapy

Conditions: Metastatic Castration-Resistant Prostate Cancer

Summary: the purpose of this treatment protocol is to provide expanded access to mdv3100 and monitor its safety in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel-based chemotherapy.

the united states food and drug administration (fda) and health canada have approved mdv3100 (enzalutamide) for sale to the public, enrollment is closed in both the united states and canada. the expanded access treatment protocol is being conducted while marketing approval of enzalutamide is being sought. there is no age requirement. subjects will complete visits on day 1, week 4, week 12 and then every subsequent 12 weeks until discontinued from the study. the study will end if enzalutamide is approved for sale to the public by the country's health authority (commercially available) or if the sponsor otherwise decides or is required to end the study. if a subject would like to receive enzalutamide after the study ends, he and the doctor will decide if he should receive a prescription for enzalutamide, with a goal of avoiding any interruption in treatment.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed adenocarcinoma of the prostate * ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (gnrh) analogue (agonist or antagonist) or orchiectomy * at least one prior chemotherapy regimen for metastatic castration-resistant prostate cancer with at least one regimen containing docetaxel * progressive disease as evidenced by prostate specific antigen (psa) rise or radiographic or clinical worsening of disease * no known or suspected brain metastasis * there is no comparable or satisfactory alternative therapy to treat the subject's disease * eastern cooperative oncology group (ecog) performance status of 0-2 exclusion criteria: * history of seizure or any condition that may predispose to seizure including, but not limited to underlying brain injury, stroke, primary brain tumors, brain metastases, or alcoholism * history of loss of consciousness or transient ischemic attack within the last 12 months * clinically significant cardiovascular disease * following lab values: * absolute neutrophil count is \<1,000/µl * platelet count is \<50,000/µl * hemoglobin is \< 5.6 mmol/l (9 g/dl) * total bilirubin ≥1.5 x upper limit of normal (uln) * alanine aminotransferase (alt) or aspartate aminotransferase (ast) ≥2.5 x uln * creatinine clearance is less than 30 ml/min by the cockcroft and gault formula * subject's conditions suggests that a bone fracture or complication of a bone fracture (such as compression of the spinal cord or other nerves) is likely to occur very soon * subject has participated in a previous clinical study of mdv3100 for which the primary endpoint has not yet been reported (e.g., the prevail trial)

Keywords: prostate mdv3100 cancer
bone health in patients with overgrowth

Conditions: Bone Mineral Density; Vascular Malformations

Summary: the goal of this study is to determine whether or not patients with overgrowth syndromes have decreased bone density.

it is known that patients with complex vascular malformation are at risk of decreased bone density and even vanishing bone disease. however, what is not known is if patients with ogs are at decreased bone density at locations that are distant from the vascular malformation. this study will look at bone health in patient's with ogs in a cross sectional fashion. if they are found to be at a particular risk for decreased bone density then this can be addressed in early childhood, through nutrition and activity recommendations. the study will consist of 15 participants, all who have a known clinical diagnosis of an overgrowth syndrome, and will be \>5 years old so that they can co operate with a dexa or xtreme ct scan. study specifics: * they will be asked specific questions regarding medical and family history and an intake form will be filled out. * the height, weight, body mass index and tanner stage measurements will be recorded during this visit. * photos of the affected area(s) will be taken, however, this is optional. * a urine pregnancy test will be done in all females of childbearing potential . * laboratory studies will be performed in all patients. * a 24-hour urine sample will be collected from adults who are able and willing; in children and in those not able or unwilling to provide a 24-hour urine, a spot urine will be collected. * bone age will be assessed via plain film of the wrist * bone density will be assessed for each patient via dexa scan * cortical and trabecular parameters and bone strength will be assessed by hrpqct

Eligibility criteria:
inclusion criteria: * age \> 5 years such that the patient is able to cooperate with the dxa scan or xtreme ct * known clinical diagnosis of an overgrowth syndrome such as klippel-trenaunay syndrome, clove syndrome, proteus syndrome, diffuse capillary malformation with overgrowth, or other unspecified ogs. exclusion criteria: * age \< 5 years * inability to comply with the scan * no or uncertain diagnosis of an ogs. * prior bisphosphonate use * systemic steroids in the past 6 months * pregnant women
oxygen treatment and pulmonary arterial hypertension

Conditions: Pulmonary Arterial Hypertension

Summary: pulmonary arterial hypertension (pah) is a disease characterised with significant morbidity and poor prognosis. dyspnoea and impaired exercise capacity are very common manifestations of the disease, and result in significant impairment of patients' quality of life. although hypoxemia is common among subjects with pah, published data on the effects of supplementary oxygen therapy on specific clinical outcomes among these patients are currently few, while the existing data on the potential benefits of oxygen supplementation to treat exercise-induced hypoxemia, in this patient population, are even more controversial. based on the aforementioned, the purpose of this prospective, crossover clinical trial is to investigate the acute effects of supplemental oxygen administration on the: a) exercise capacity, b) severity of dyspnea, c) cerebral oxygenation, b) muscle oxygenation, and e) hemodynamic profile, as compared to delivery of medical air (sham oxygen), in a group of patients with pah, during steady state cardiopulmonary exercise testing (cpet)


Eligibility criteria:
inclusion criteria: 1. group i pah patients 2. stable disease (no hospitalisation, disease deterioration or change in regular pah medication during the last month) 3. presence of exercise-induced hypoxemia exclusion criteria: 1. major contraindications for cpet conduction 2. not providing informed consent -
effect of computer-based cognitive function training on cognitive dysphagia after stroke

Conditions: Dysphagia

Summary: this is a multicenter randomized controlled study. the study recruited stroke patients with mild cognitive impairment and dysphagia who were undergoing inpatient rehabilitation treatment in three hospitals in mainland china as the participants (study subjects). the study duration for each participant was 15 days. the subjects were randomly divided into an experimental group and a control group. during the treatment, all patients received routine rehabilitation treatment. in addition, patients in the control group received conventional cognitive training, while patients in the experimental group received computer-assisted cognitive training.

computer-assisted cognitive training is a rehabilitation method that uses computer technology and psychological principles to promote the recovery of cognitive function.this is a multicenter randomized controlled study. the study recruited stroke patients with mild cognitive impairment and dysphagia who were undergoing inpatient rehabilitation treatment in three hospitals in mainland china as the participants (study subjects). the study duration for each participant was 15 days. the subjects were randomly divided into an experimental group and a control group. during the treatment, all patients received routine rehabilitation treatment. in addition, patients in the control group received conventional cognitive training, while patients in the experimental group received computer-assisted cognitive training.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * meeting the diagnostic criteria for traumatic brain injury, confirmed by magnetic resonance imaging. * montreal cognitive assessment score \ 18 (adjusted by 1 point if the educational level is high school graduation or above). * confirmed swallowing disorder through fiberoptic endoscopic examination of swallowing. * duration of illness greater than three months. * patients or their family members are aware of and consent to participate in the study. exclusion criteria: * presence of other intracranial lesions, such as stroke. * cognitive impairment caused by other diseases. * mental abnormalities. * inability to complete treatment and assessments due to other impairments. * concurrent severe injuries.
perioperative effects of operating room virtual tour

Conditions: Preoperative Care; Anxiety; Emergence Delirium; Postoperative Complications

Summary: preoperative anxiety is associated with adverse consequences such as emergence delirium, and postoperative behavioral changes. according to previous studies, providing information of anesthetic procedures helps to lessen preoperative anxiety. however, verbal explanation alone provides the limited effect, and the tour program of the operating room prior to surgery may not be possible for a number of hospitals due to organizational and financial reasons. therefore, the virtual reality (vr) tour of the operating room may be an innovative and novel method to give children information about the preoperative process and to alleviate the preoperative anxiety. in this study, we intend to evaluate the effects of the operating room virtual tour on preoperative anxiety as well as emergence delirium and postoperative behavioral changes, in pediatric patients.


Eligibility criteria:
inclusion criteria: * elective surgery * american society of anesthesiologist (asa) physical class i, ii * informed consent; children aged between 4 and 6 years old are allowed to have verbal consent and their parents provide informed written consent. children over the age of 7 are required to obtain a written consent with parental permission. exclusion criteria: * asa class ≥ iii * major surgery needing postoperative intensive care unit (icu) admission. * chronic disease or history of preterm birth * developmental delay * hearing or vision impairment * affective disorder * history of epilepsy or seizure * previous experience of general anesthesia
a long-term safety extension trial of ferric citrate in patients with end-stage renal disease (esrd) on dialysis

Conditions: End Stage Renal Disease; Kidney Failure; Renal Failure; Hyperphosphatemia; ESRD

Summary: a long-term safety study of ferric citrate (krx-0502) in renal failure patients who have completed study krx-0502-304. only patients who participated in the krx-0502-304 trial may participate in this trial.

this study was an open-label, 48-week safety extension of study krx-0502-304 (study 304), to evaluate the safety of long-term use of krx-0502 in subjects with esrd for up to 2 years of cumulative exposure. subjects who completed the safety assessment period (sap) and, if eligible, the efficacy assessment period (eap) of study 304, independent of their assigned treatment arm in the sap or eap of study 304, were eligible for participation in this long-term safety extension study. no new subjects were permitted to enter this study.

Eligibility criteria:
inclusion criteria: 1. males or non-pregnant, non-breast-feeding females who participated in the safety assessment period (sap), and if eligible, the efficacy assessment period (eap) of study krx-0502-304 2. willing and able to give informed consent exclusion criteria: 1. subjects on krx-0502 (ferric citrate) in krx-0502-304 who were treatment failures in first period 2. any subject in study krx-0502-304 sap who early terminated from the trial 3. any subject who participated in study krx-0502-304 but declined eap 4. actively symptomatic gastrointestinal bleeding or inflammatory bowel disease 5. history of malignancy in the last five years 6. previous intolerance to krx-0502 (ferric citrate) 7. intolerance to oral iron-containing products 8. absolute requirement for oral iron therapy 9. absolute requirement for vitamin c (multivitamins \[nephrocaps, renaphro, etc.\] allowed) 10. absolute requirement for calcium-, magnesium-, or aluminum-containing drugs with meals 11. inability to tolerate oral drug intake 12. any other medical condition that rendered the subject unable to or unlikely to complete the trial or that would interfere with optimal participation in the trial or produce significant risk to the subject 13. inability to cooperate with study personnel or history of noncompliance 14. unsuitable for this trial per principal investigator's (pi) clinical judgment.

Keywords: participation limited long term safety extension
pulmonary vein (pv) imaging by intracardiac echography (ice) after ablation

Conditions: Atrial Fibrillation Recurrent

Summary: to test the hypothesis that structural changes documented by ice after pulmonary vein deconnection by rf can predict af recurrences

patient undergoing first rf ablation for sympomatic paroxysmal atrial fibrillation will be enrolled. ice visualization of pv antra before and after pv deconnection (electrophysiological endpoint). changes in echogenicity as documented by ice will be evaluated by a dedicated software and correlated to long term recurrences

Eligibility criteria:
inclusion criteria: * atrial fibrillation ablation candidates exclusion criteria: * previous catheter ablation * persistent atrial fibrillation
vertistop® d and vertistop® l in preventing recurrence of high-recurrence bppv

Conditions: Benign Paroxysmal Positional Vertigo (BPPV)

Summary: randomized, 3-arm controlled clinical study, to evaluate the effectiveness of supplementation with vertistop® d (food supplement containing alpha-lipoic acid at modified release, carnosine and zinc, vitamin d and vitamins b) and vertistop® l (food supplement containing fast releasing alpha-lipoic acid, carnosine, zinc and curcumin) in preventing recurrence of high-recurrence bppv (benign paroxysmal positional vertigo)

benign paroxysmal positional vertigo (bppv) is the most common type of vertigo detectable in otoneurological clinical practice. it is characterized by violent, short and relapsing vertiginous crises that arise when the patient assumes certain positions of the head in the space and is accompanied by a usually "typical" paroxysmal positional nystagmus. in most cases we cannot trace the exact causal agent, so we mainly identify two forms: primitive forms and secondary forms. bppv therapy is essentially physical, and it is based on specific maneuvers which make the otoconial mass come out of the semicircular canal. recent studies showed the existence of a seasonal trend of bppv related to fluctuations in vitamin d levels. based on these considerations this clinical trial was designed in order to evaluate the possible efficacy of the administration of vitamin d (vertistop® d) in preventing recurrence of bppv.

Eligibility criteria:
inclusion criteria: * diagnosis of primary bppv; * patients having bppv of csp or csl (geo or apo, single or multi channel); * patients with recurrent bppv, defined as two or more episodes over the last six months, or three or more episodes in the last 12 months; * informed consent. exclusion criteria: * patients under 18 years of age; * secondary bppv; * vitamin d levels greater than 100 ng/ml (\>250 nmol/l); * pregnant or breastfeeding.

Keywords: bppv vertistop vitamin d alpha-lipoic acid zinc
evaluation of touch massage on anxiety in critically ill patients

Conditions: Anxiety

Summary: anxiety is a common problem encountered in a about 43 % of critically ill patients. its occurrence can be related to several causes, mainly dominated by invasive procedures. anxiety management is typically based on a combination of prevention, evaluation, and therapeutic agents. however, it appears important to develop adjuvant approaches. touch massage is one of them and that has been evaluated in various medical conditions. the aim of our study is to evaluate the anxiolytic effect of touch massage in critically ill patients during potentially painful nursing procedures.


Eligibility criteria:
inclusion criteria: * all adult patients (age≥18 years) hospitalized in intensive care unit \> 24 h * requiring mechanical ventilation or not * securité sociale affiliated * patient with accessible zone for touch massage (head-face, arms-hands, feet, legs and back) * no significant event (invasive procedure, diagnostic ad, cat,mri) before enrollment exclusion criteria: * pregnant * legal guardianship * neurological failure : stroke ischemic or hemorrhagic, meningitis, status epilepticus,polytrauma( including head trauma),meningo encephalitis, meningism, * patient with upper limbs neuromuscular disorders * cutaneous lesion (zone of touch massage) * temperature ≥ 38,5°c * a positive score of cam icu scale * patient refuse to participate

Keywords: anxiety intensive care mechanical ventilation touch massage
post-rai therapy dosimetry and quality assessment of target tissue dosing

Conditions: Thyroid Disease

Summary: the goal of this clinical trial study is to(1) determine the tissue specific dose of i-131 taken up by residing thyroid issue in the thyroid bed post-rai along with any other sites in the neck and mediastinum as well as (2) correlate the dose delivered to residual tissues in the neck with patient follow-up based clinical outcomes, biochemical and imaging data following rai therapy in patients with well-differentiated thyroid cancer (dtc). the main question\[s\] it aims to answer are: * \[question 1\] how can obtained whole body and planar images more adequately depict residual iodine-avid disease in the thyroid bed, neck or mediastinum? * \[question 2\] how can we obtain information on the dose taken up by the tumor remnant to know how much radionuclide actually went to the residual disease/tissue? participants will \[describe the main tasks participants will be asked to do, treatments they'll be given and use bullets if it is more than 2 items\].

in our current clinical practice, patients with well-differentiated thyroid cancer (dtc) who receive oral administration of radioiodine 1-131 (rai) have whole body and planar images obtained 4-5 days post-treatment. these images often do not adequately depict residual iodine-avid disease in the thyroid bed, neck or mediastinum. further, no information about what dose taken up by the tumor remnant is obtained and thus we are unable to know how much radionuclide actually went to the residual disease/tissue. using single photon emission computed tomography (spect)/ct we will be able to better localize and evaluate disease/tissue remnant or distant iodine-avid metastatic disease. in addition, using varian velocity theranostics dosimetry suite of software applications, we will be able to do dosimetry on post-rai therapy patients and be able to better correlate clinical outcomes with tumor absorbed dose in addition to provide quality improvement for the radioiodine ablation.

Eligibility criteria:
inclusion criteria: * all minorities * 18 years of age and older * ability to give consent * male or female * differentiated thyroid cancer (dtc) * previous total thyroidectomy * has either: * local lymph node metastases * distant mediastinal/cervical metastases * lung or osseous metastases as seen on prior imaging studies exclusion criteria: * non-iodine avid disease * under 18 years of age * unable to give consent * pregnant women, non-viable neonates or neonates of uncertain viability. * non-english-speaking patients

Keywords: i-131
a study to evaluate oral vt-1161 in the treatment of patients with recurrent vaginal candidiasis (yeast infection)

Conditions: Recurrent Vulvovaginal Candidiasis

Summary: vt-1161 is a novel, oral inhibitor of fungal lanosterol demethylase (cyp51). in vitro and in vivo pharmacology studies have demonstrated that vt-1161 is highly active against candida albicans and also non-albicans candida species that cause vulvovaginal candidiasis. vt-1161 is highly selective for fungal cyp51, and data suggests that it may avoid the side-effect profile that limits the use of commonly prescribed antifungal agents for the treatment of recurrent yeast infections.


Eligibility criteria:
key inclusion criteria: clinical diagnosis of symptomatic acute vvc 3 or more episodes of acute vvc in the past 12 months positive koh minimum composite vulvovaginal signs and symptoms score of ≥3 at screening composite vulvovaginal signs and symptoms score of \<3 at baseline must be able to swallow tablets key exclusion criteria: evidence of major organ system disease presence or a history of another vaginal or vulvar condition(s) history of cervical cancer poorly controlled diabetes mellitus pregnant recent use of topical or systemic antifungal drugs recent use of immunosuppressive or system corticosteroid therapies
vasomotoric symptoms study of a 0.5 mg estradiol and 2.5 mg dydrogesterone combination

Conditions: Postmenopause

Summary: to demonstrate efficacy of continuous combined 0.5 mg estradiol and 2.5 mg dydrogesterone versus placebo in the treatment of vasomotor symptoms after a treatment period of 3 months and to investigate the bleeding pattern over a treatment period of one year


Eligibility criteria:
inclusion criteria: * non-hysterectomised postmenopausal women * amenorrhoea for \>= 12 months * serum estradiol and follicle stimulating hormone (fsh) in the postmenopausal range exclusion criteria: * known hypersensitivity to estradiol, dydrogesterone or any of the excipients of the study medication * baseline endometrial biopsy result other than described in the inclusion criteria (no endometrial tissue for diagnosis, hyperplasia, carcinoma). * insufficient endometrial tissue for diagnosis obtained at baseline biopsy and endometrial thickness \>= 5 mm (double layer) by transvaginal ultrasound. * the presence of an endometrial polyp at baseline. * abnormal (un-investigated and/or unexplained) vaginal bleeding in the last 12 months prior to screening visit (visit 1). * estradiol pellet/implant therapy during the past 6 months. * previous systemic unopposed estrogen replacement therapy over 6 months or more. * history or presence of malignant neoplasms other than basal or spinal cell carcinoma of the skin

Keywords: hormone replacement vasomotoric symptoms bleeding pattern