Kornimate/medical-research-clean huggingface dataset:
extension of solumatrix tm abiraterone acetate in patients who completed study number chl-aa-201

Conditions: Prostate Cancer

Summary: an open-label extension (ole), expanded access study, to assess long-term safety of solumatrix™ abiraterone acetate 500mg (4 x 125 mg qd) with methylprednisolone (4mg bid) in patients who completed study number chl-aa-201.

an open-label extension (ole), expanded access study, to assess long-term safety of solumatrix™ abiraterone acetate 500mg (4 x 125 mg qd) with methylprednisolone (4mg bid) in patients who completed study number chl-aa-201. an exploratory endpoint of improved safety from switching from zytiga (aberaterone acetate 1000mg(4 x 250 mg qd) to solumatrix™ abiraterone acetate 500mg (4 x 125 mg qd) will also be ascertained..

Eligibility criteria:
inclusion criteria: 1. written informed consent obtained prior to any study-related procedure being performed 2. previous, uninterrupted enrollment and treatment in trial number chl-aa-201. exclusion criteria: 1. progressive disease as ascertained by the investigator using standard-of-care evaluations. 2. chl-aa-201 d84 blood counts of the following: 1. absolute neutrophil count \> 1500/µl 2. platelets \> 100,000/µl 3. hemoglobin \> 9 g/dl 3. chl-aa-201 d84 chemistry values of the following: 1. alanine aminotransferase (alt) and aspartate aminotransferase (ast) \< 2.5 x upper limit of normal (uln) 2. total bilirubin \< 1.5 x uln 3. creatinine\< 1.5 x uln 4. albumin \> 3.0 g/dl 5. potassium \> 3.5 mmol/l

Keywords: prostate cancer castrate resistant prostate cancer (crpc) metastatic castrate resistant
rib fracture cryoanalgesia

Conditions: Pain Management Improvement

Summary: rib fractures lead to poor patient outcomes and even death 3. data suggests effective pain management is crucial to obtain favorable outcomes 4, 5current outpatient treatment modalities are limited to oral or topical medications with low efficacy and high risk for opioid dependence. in-patient management with a thoracic epidural tea is largely considered the gold standard, but the risks of tea may outweigh the benefits 6 to 8.

methodist dallas medical center mdmc is an urban level i trauma center that manages over 200 rib fracture cases annually. mdmc has a history of developing and using innovative analgesia techniques aimed at improving outcomes. in 2010 we first described the need for advancements in the treatment of rib fracture patients 1. later, we validated the technique that is now used at hundreds of trauma centers around the world 2. our surgical and research teams have a history of advocating for optimal management of rib fracture pain in order to prevent serious complications. this study will seek to describe the effective use of cryoanalgesia as a feasible method of pain management in the rib fracture patient. with a small cohort and case series, we will describe and refine the procedure and preliminary efficacy of the fda-approved iovera system in adult rib fracture patients. in order to ethically assess the clinical relevance of the iovera system, our objective will be accomplished by completing a case series

Eligibility criteria:
inclusion criteria: * 18 years of age acute pain attributed to rib fracture(s) able to obtain consent exclusion criteria: * \<18 years of age pregnant incarcerated confounding injuries or significant pain attributed to secondary injury patients with any of the following: cryoglobulinemia; paroxysmal cold hemoglobinuria; cold urticarial; raynaud's disease; open and/or infected wounds at or near the treatment site
safety and efficacy of vildagliptin vs. thiazolidinedione as add-on therapy to metformin in patients with type 2 diabetes not controlled with metformin alone

Conditions: Diabetes Mellitus, Type 2

Summary: this study is designed to evaluate, in a primary care setting, the safety and efficacy of vildaglipgtin as add on therapy to metformin relative to tzd added to metformin in patients with type 2 diabetes inadequately controlled by metformin alone.


Eligibility criteria:
inclusion criteria: * patients who have received a stable dose of metformin consisting of at least 1,000 mg/day for four weeks prior to visit 1 (week-2) * agreement to maintain the same dose of metformin from screening to the end of the study * age in the range of 18-80 years * body mass index (bmi) in the range of 22-40 kg/m2 * hba1c in the range of 7.0 to 10% * fpg \<270 mg/dl (15 mmol/l) exclusion criteria: * a history of type 1 diabetes * liver disease * treatment with insulin or any oral anti-diabetic other than metformin, within 8 weeks prior to visit 1 other protocol-defined inclusion/exclusion criteria may apply

Keywords: type 2 diabetes vildagliptin hemoglobin a1c metformin
safety and tolerability of lx101 for inherited retinal dystrophy associated with rpe65 mutations

Conditions: Inherited Retinal Dystrophy Associated With RPE65 Mutations

Summary: the purpose of the study is to evaluate the safety, tolerability and efficacy of lx101 in subjects with biallelic rpe65 mutation-associated inherited retinal dystrophy.


Eligibility criteria:
inclusion criteria: subject and/or their guardian signing a written informed consent. diagnosed with biallelic rpe65 mutation-associated inherited retinal dystrophy. subjects are 6 years of age or older. visual acuity of ≤ 20/63 or visual field less than 20 degrees in the eye to be injected. exclusion criteria: prior gene therapy for ird and other hereditary eye diseases. pre-existing eye conditions that would interfere with interpretation of study endpoints. active intraocular or periocular infections in the study eye. lacking of sufficient surviving retinal cells. prior ocular surgery within six months. complicating systemic diseases or clinically significant abnormal baseline laboratory values. pre-existing systemic diseases that should not discontinue the use of any retinal toxic compounds.
home-administered tdcs for treatment of depression

Conditions: Unipolar Depression; Treatment Resistant Depression

Summary: this study will determine the safety and efficacy of home administered tdcs in adults with unipolar depression. the device used to administer tdcs will be the soterix medical 1x1 mini-ct. 32 tdcs sessions of 30 minutes each will be delivered over 10 weeks.

the soterix medical 1x1 mini-ct will be used to determine the safety and efficacy of home-based transcranial direct current stimulation (tdcs) in treating unipolar depression. specifically efficacy will be determined by change in madrs score from baseline to the 10 week follow-up. feasibility and compliance will be determined by low drop out rate and percentage of scheduled sessions completed. self-reported mood scores will be evaluated using the quick inventory of depressive symptomatology (qids-sr) and quality of life enjoyment and satisfaction questionnaire form (q-les-q-sf). all visits will be performed via telephone or video conference. subjects will be taught to operate the tdcs system and complete a tolerability check. the treatment course will consist of an acute phase of 28 tdcs sessions conducted monday - friday over 6 weeks. this is followed by a taper of 4 tdcs sessions spaced 1 week apart. patients who meet criteria for clinical response (\>=50% improvement in madrs) may continue with maintenance treatments of once a week for 2 months and once every 2 weeks for the remaining 3 months. mood assessments will be conducted at baseline, 2 weeks, 4 weeks and 6 weeks in the acute treatment phase. in the taper phase, assessments wil be conducted at 1 month (end of taper), 3 and 6 months following completion of the acute phase. all assessments in the acute treatment phase and the taper phase will have a +/- 1 week collection window.

Eligibility criteria:
inclusion criteria: * clinically stable patients that meet criteria for diagnosis of mdd according to dsm-v-tr and confirmed with the mini international neuropsychiatric interview. * currently experiencing a major depressive episode of at least 4 week's duration as part of a unipolar depression * scored at least 20 on the madrs at trial entry * patient's antidepressant medication is stable for at least 30 days prior to madrs screening * female patients are allowed if not pregnant and are using a medically acceptable method of contraception, if of childbearing potential exclusion criteria: * dsm-v-tr psychotic disorder * drug or alcohol abuse or dependence in the preceding 3 months * concurrent benzodiazepine medication * high suicide risk * history of clinically defined neurological disorder or insult * metal in the cranium or skull defects * subjects with an implanted pump, neurostimulator, cardiac pacemaker or defibrillator * skin lesions on scalp at the proposed electrode sites * pregnancy

Keywords: tdcs
real world asparaginase therapy toxicity

Conditions: Drug Toxicity

Summary: this research study is being done to learn more about the short term and long term side effects of treatment with asparaginase drugs, which are commonly used in acute lymphoblastic leukemia (all) or acute lymphoblastic lymphoma (lly) therapy.

primary objective * to estimate the rate of high-grade toxicities which occur during therapy for acute lymphoblastic leukemia/ lymphoma in patients receiving asparaginase-containing standard of care therapy. this study will involve the collection of data about the participants all/lly, treatment, side effects of treatment and leukemia/ lymphoma's response to treatment. data collected on other research studies participants are enrolled on will also be used for this research study. blood samples will be collected and liver fibroscans (liver ultrasounds) will be done at different time points while the participant is receiving treatment for all/lly. the time points will depend on what treatment they receive and will correspond to days on their treatment roadmap.

Eligibility criteria:
inclusion criteria: * diagnosis of acute lymphoblastic leukemia, lymphoblastic lymphoma, or mixed phenotype acute leukemia * enrolled on initiall and no more than 10 days after initiation of post-initiall therapy * post-initiall therapy is: * standard of care (soc)/non protocol treatment plan (nptp) as per total therapy or * sjall23t and not scheduled to receive venetoclax exclusion criteria: * inability or unwillingness of research participant or legal guardian/representative to give written informed consent.

Keywords: asparaginase drugs toxicity acute lymphoblastic leukemia acute lymphoblastic lymphoma mixed phenotype acute leukemia
phase 1 clinical trial to investigate the effect on the pharmacokinetics of yh14755 compared to co-administration of rosuvastatin and metformin sr in healthy volunteers

Conditions: Healthy

Summary: the objective of this study is to compare the safety and the pharmacokinetic characteristics of the co-administration of rosuvastatin and metformin sr and yh14755 and to investigate the effect of food on the pharmacokinetics of yh14755 in healthy volunteers.


Eligibility criteria:
inclusion criteria: 1. healthy male and female with a body mass index(bmi) between 18.5 and 25 kg/m2 2. who has not suffered from clinically significant disease 3. provision of signed written informed consent exclusion criteria: 1. history of and clinically significant disease 2. a history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs. 3. administration of other investigational products within 3 months prior to the first dosing. 4. administration of herbal medicine within 4 weeks or administration of ethical drugs within 2 weeks or administration of over-the-counter (otc) drugs within 1 week prior to the first dosing of the investigational product (if the investigator (study doctor) determines that the person meets other criteria appropriately, the relevant person may participate in the study). 5. volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ecgs, or vital signs.
a phase ii, parallel group, randomized, placebo-controlled study of the safety and efficacy of thalidomide in reducing weight loss in adults with hiv wasting syndrome

Conditions: HIV Infections; HIV Wasting Syndrome

Summary: to evaluate the safety, antiviral and anti-tnf-alpha activity, and preliminary efficacy of thalidomide in reducing weight loss in patients with hiv wasting syndrome.

patients are randomized to receive either thalidomide at 1 of 2 doses or placebo for 8 weeks. patients who respond may continue in double-blinded treatment for an additional 4 weeks; nonresponding patients may receive thalidomide for up to 4 weeks. per amendment, patients may receive thalidomide for more than 12 weeks on a compassionate basis.

Eligibility criteria:
inclusion criteria concurrent medication: allowed: * primary prophylaxis for opportunistic infections (if afb blood culture negative). * chronic suppressive therapy (maintenance) for opportunistic infections other than mycobacterium avium complex (mac). patients must have: * documented hiv infection. * wasting syndrome. * negative blood pcr for acid-fast bacteria (afb) or a negative afb blood culture within 48 days prior to study entry. * no active opportunistic infection requiring systemic therapy within 6 weeks prior to study entry. * life expectancy of at least 6 weeks. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * chronic diarrhea (five or more unformed stools per day). * peripheral neuropathy of grade 2 or worse. * requirement for tube feeding or intravenous feeding. * any disorder associated with moderate to severe edema (e.g., cirrhosis, nephrosis, congestive heart failure). * inability to ingest at least a maintenance diet based on present weight. * any condition that precludes study participation. * not under the care of a primary physician. concurrent medication: excluded: * chronic suppressive therapy (maintenance) or secondary prophylaxis for mycobacterium avium complex (mac) (suppressive therapy for other opportunistic infections is allowed). concurrent treatment: excluded: * radiotherapy. patients with the following prior conditions are excluded: * any neoplasms other than non-medicated (i.e., not receiving systemic or intralesional chemotherapy) kaposi's sarcoma within 1 month prior to study entry. * prior intolerance to thalidomide. prior medication: excluded: * ddc within 1 month prior to study entry. * acute systemic therapy for opportunistic infections within 6 weeks prior to study entry. * agents that are anabolic, catabolic, or immunomodulatory (including interferons, megestrol, dronabinol, oxandrolone, growth hormone, systemic corticosteroids, and pentoxifylline) within 30 days prior to study entry. prior treatment: excluded: * radiotherapy within 6 weeks prior to study entry. required only if patient is on antiretroviral therapy: * stable regimen of azt or ddi for at least 1 month prior to study entry. active drug abuse within 3 months prior to study entry.

Keywords: acquired immunodeficiency syndrome cachexia thalidomide
accuracy of hystro-salpingo-foam-sonography (hyfosy) as tubal patency test in comparison to laparoscopy in infertile patients

Conditions: Infertility, Female

Summary: tubal patency testing is an essential part of female subfertility evaluation . tubal abnormalities are seen in 30-40% of female subfertility patients . laparoscopy with chromopertubation is considered to be the gold standard diagnostic procedure . laparoscopy is an invasive test, with a risk of intra-abdominal bleeding, visceral damage, and risks related to general anaesthesia. traditionally, hysterosalpingography(hsg) is a less invasive less expensive first-step alternative, which has been used for decades with disadvantages such as radiation exposure, discomfort, or even abdominal pain. hysterosalpingo-contrast sonography (hycosy) was introduced as an alternative using either contrast media or saline. the accuracy of hycosy is comparable to that of hsg and lsc being reference standards for tubal patency testing.however, hyperechogenic contrast media such as echovist_ (schering ag, berlin) and sonovue_ (bracco, milan)are either no longer available or not licensed for tubal patency testing. hysterosalpingo-foam sonography (hyfosy) was developed as an alternative for contrast hycosy and was introduced in 2010 as a first-line office tubal patency test.foam is used in the hyfosy technique to visualize the fallopian tubes and is created by rigorously mixing 5mlexem_-gel (containing hydroxyethyl cellulose and glycerol,iqmedical ventures bv, rotterdam, thenetherlands) with 5ml purified exem_-water. the exem_-foam is sufficiently fluid to pass the fallopian tubes and in the mean time sufficiently stable to show echogenicity for at least five minutes, which is an advantage over saline. in a review on safety aspects and side effects of exem-gel it was considered to be appropriate and safe for tubal patency testing. in 2017, hylifosy combined with power doppler (pd)(hylifosy-pd) technique was described as a possibly less painful and easier to detect on ultrasound alternativeto hyfosy and hycosy, which can be used whenever the contrast media used with both are either unavailable or is relatively expensive ultrasound-based tubal patency tests include hysterosalpingo-contrast sonography (hycosy), hysterosalpingo-foam sonography (hyfosy), and hysterosalpingo-lidocaine-foam sonography (hylifosy)and have shown a high detection rate of tubal obstruction and good reproducibility with concordances from 83.8 to 100% with hsg, and from 78.1 to96.91% with lap-and-dye test. in addition, they allow for a single comprehensive assessment of the uterus and the fallopian tubes and it can be performed by the same specialist who indicates it, in the clinician's own office with it consequently being time efficient. finally, some studies have shown an increase in the rate of post-procedure gestation.


Eligibility criteria:
inclusion criteria: 1. women aged 18-40 2. sexually active 3. infertility or subfertility primary and secondary exclusion criteria: 1. current pregnancy 2. heavy menstrual bleeding 3. peivic inflammatory disease 4. allergy to lidocaine
mirror neuron network based motor imagery training to improve brain computer interface performance in spinal cord injury patients

Conditions: Spinal Cord Injuries

Summary: the overall vision of this proposal is to demonstrate that a virtual reality based motor imagery training program will improve brain computer interface (bci) performance and motor function in quadriplegic subjects. the ultimate goal is to increase the independence of subjects with spinal cord injury by training to safely control bci assistive devices and to enhance motor recovery.

intend to train subjects in motor imagery techniques using an advanced virtual reality based platform. hypothesize that this will enhance the cortical signals necessary for operating a non-invasive eeg-based bci. specifically, designed training paradigms will activate "mirror neurons" associated with performance of movement, observation of movement, and motor imagery. mirror neuron network (mnn) activation induces cortical plasticity, and may therefore enhance cortical signals generated during bci use. plan to assess the effect of training paradigm on cortical signals generated during motor imagery, using eeg. also, investigate neuropsychological factors that play a role in a subject's ability to generate vivid motor imagery. eight subjects with spinal cord injury (sci) will be recruited during the sub-acute phase (3-6 months following injury). four participants will immediately undergo motor imagery training in an immersive virtual reality environment at nasa. eeg assessments and motor function testing will be performed at intervals during the 3-4 week motor imagery training period to assess improvement in cortical signature generation and motor recovery. the other four participants will undergo the same protocol after a 6 week delay, in order to assess the effect of training timing after injury in both cortical signature generation and motor function recovery.

Eligibility criteria:
inclusion criteria: * sustained incomplete spinal cord injury (american spinal injury impairment scale) at a level of c5-7 within three to six months prior to enrollment exclusion criteria: * unstable or acute medical or psychiatric illness; pregnancy; epilepsy; diabetes; autism spectrum disorder, history of severe traumatic brain injury or stroke, and those taking medications that may interfere with eeg readings, including beta blockers and sedatives.

Keywords: motor imagery spinal cord injury motor function improvement
triage strategies in cervical cancer prevention

Conditions: Cervical Cancer; Intraepithelial Neoplasia

Summary: while there is broad consensus that hr-hpv detection is the best available primary screening test, there is no agreement about the most efficient and reliable triage procedure for hr-hpv positive women. transient hr-hpv infections are very common, and the vast majority of these infections spontaneously regress after a year or two. only a small fraction of cases will lead to persistent infection responsible for cervical neoplasia. the frida study is a large, population-based study that was designed to evaluate the performance and cost-effectiveness of different triage strategies for hrhpv-positive women in mexico.

the target population is over \<100,000 women aged 30 to 64 years who attend the cervical cancer screening program in 100 health centers in the state of tlaxcala, mexico. all women will be evaluated to determine hrhpv infection using the cobas® 4800 hpv test. triage strategies will be performed as reflex tests in all hrhpv-positive participants: hpv-16/18/45 genotyping, detection of the e6 oncoprotein of hpv-16/18, cytology, and immunocytochemistry using p16ink4a/ki67. women with at least one positive triage test will be referred for colposcopy evaluation, where a minimum of four biopsies and an endocervical sample are systematically collected. histological confirmation will be performed by a standardized panel of pathologists.

Eligibility criteria:
inclusion criteria: * women aged 30 to 64 * residents of the municipalities included in sanitary jurisdiction no. 1 of tlaxcala. exclusion criteria: * pregnant or hysterectomized women * legally disabled women unable to give verbal informed consent required by the study protocol * women who do not wish to participate in the present study

Keywords: hpv testing triage mexico cervical cancer screening