Kornimate/medical-research-clean huggingface dataset:
effect of androgen receptor signaling inhibitors on 68ga-psma-11 pet/ct imaging in patients with castration-resistant prostate cancer

Conditions: Castration-Resistant Prostate Carcinoma; Metastatic Prostate Carcinoma; Stage IV Prostate Cancer American Joint Committee on Cancer (AJCC) v8; Stage IVA Prostate Cancer AJCC v8; Stage IVB Prostate Cancer AJCC v8

Summary: this trial studies the effect of androgen receptor signaling inhibitors on 68ga-psma-11 pet/ct imaging in patients with castration-resistant prostate cancer that has spread to other places in the body (metastatic). diagnostic procedures, such as 68ga-psma-11 pet/ct, may help in learning how well androgen receptor signaling inhibitors work in killing castration-resistant prostate cancer cells and allow doctors to plan better treatment.

primary objective: i. to evaluate short- and long-term prostate specific membrane antigen (psma) imaging changes in response to androgen receptor signaling inhibitors (arsi). secondary objectives: i. to correlate psma imaging changes with prostate specific antigen (psa) kinetics. ii. to correlate psma imaging changes with progression free survival. iii. to evaluate the changes in psma pet staging (mitnm prostate cancer molecular imaging standardized evaluation \[promise\] criteria) under arsi. outline: patients receive gallium ga 68-labeled psma-11 (68ga-psma-11) intravenously (iv). after 50-100 minutes, patients undergo positron emission tomography (pet)/computed tomography (ct) over 20-50 minutes. patients undergo 68ga-psma-11 pet/ct at baseline, at 1 week and 3 months after initiation of arsi, and at time of biochemical progression (within 1 year if applicable).

Eligibility criteria:
inclusion criteria: * histologically proven prostate cancer * know metastatic disease on previous imaging, or psa value ⩾ 1 ng/ml; * castration resistant disease with confirmed testosterone level =\< 50 ng/ml under prior first-line androgen deprivation therapy (adt) * new planned treatment with enzalutamide or abiraterone, darolutamide or apalutamide * willingness to undergo arsi throughout the duration of the study as prescribed by the treating uro-oncologist * stated willingness to comply with continuation of arsi treatment for the duration of the study * provision of signed and dated informed consent form exclusion criteria: * inability to provide written informed consent * known inability to remain still and lie flat for duration of each imaging procedure (about 30 minutes) * other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy * a baseline superscan pattern on bone scan * diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. however, patients with a prior history of malignancy that has been adequately treated and who have been disease free for more than 3 years are eligible
goal-directed lcvp based on hp in laparoscopic hepatectomy

Conditions: Hepatocellular Carcinoma

Summary: the goal of this clinical trial is to learn about goal-directed lcvp based on hypovolemic phlebotomy (hp) in laparoscopic hepatectomy. the main questions it aims to answer are: 1. the safety and feasibility of hp 2. to evaluate whether hp can reduce perioperative blood transfusion ratio participants undergoing liver resection with hp was performed by the anesthesiologist. blood was withdrawn approximately 30 min prior to the initiation of liver parenchymal transection from central venous. the aim was to maintain the cvp between 0 to 5 cmh2o. hp volume was 5-10 ml/kg of patient body weight, generally. participants in control group undergoing liver resection without hp.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of hepatocellular carcinoma * preference for laparoscopic hepatectomy and patient agreement exclusion criteria: * age \<18 years * pregnancy * refusal of blood product transfusion * active cardiac conditions (unstable coronary syndromes, decompensated heart failure, significant arrhythmias, severe valvular disease, history of congestive heart failure) * history of significant cerebrovascular disease * restrictive or obstructive pulmonary disease * uncontrolled hypertension * renal dysfunction (glomerular filtration rate \<60 ml/min), * hemoglobin \<100 g/l * abnormal coagulation values (international normalized ratio \>1.5 not on warfarin and/or platelet count \<100 ×109/l) * evidence of hepatic metabolic disorder (bilirubin \>35 mmol/l) * presence of active infection * preoperative autologous blood donation * patients were not allowed to receive erythropoietin at any time during the index hospitalization.

Keywords: hypovolemic phlebotomy low central venous pressure goal-directed laparoscopic hepatectomy
a study to develop a strategy to increase lung cancer screening in women who may be at risk for lung cancer

Conditions: Smoking

Summary: the purpose of this study is to develop a digital strategy to increase awareness about lung cancer screening among women who are eligible to receive it. the digital strategy involves email communications and lungtalk, a web-based (accessed through the internet) health communication tool that uses text, audio, video, and animation to increase awareness and knowledge about lung cancer screening. this study will focus on women who have recently received a screening mammogram.


Eligibility criteria:
inclusion criteria: * ldct screening-eligible women who received a birads 1 (negative) or 2 (benign/non-cancerous finding) result from a screening mammogram in the last 7 days * age 50-80 years * ≥ 20-pack-year smoking history of combustible cigarettes as per self report * women who currently smoke or quit within past 15 years as per self report * lung screening naïve as per self-report exclusion criteria: * lung cancer diagnosis * chest ct within the last 12 months

Keywords: mammogram ldct screening birads 1 birads 2 21-103 memorial sloan kettering cancer center
efficacy study of outpatient therapy for lymphoma

Conditions: Non-Hodgkin's Lymphoma; Hodgkin's Disease

Summary: this is a phase ii trial evaluating the efficacy (overall response rate) of a risk-adjusted outpatient based approach to lymphoma salvage therapy with vinorelbine, gemcitabine and pegfilgrastim and/or gemcitabine, ifosfamide, vinorelbine and pegfilgrastim.

lymphoma has been increasing in incidence annually for the past several decades and the majority of patients relapse after first line therapy. a variety of 'salvage chemotherapy' treatments are available that are usually inpatient-based treatments associated with significant haematological toxicity. furthermore, all patients are treated in the same manner despite the fact that some patients will do well irrespective of the type of salvage therapy whereas others will do badly no matter what is done. during 2001-2002 we undertook a pilot study in 40 such patients using an outpatient-based salvage therapy with 2 newer chemotherapy drugs, vinorelbine and gemcitabine. over 75% of all treatments were successfully delivered on an outpatient basis with response rates similar to historical controls. we now propose to expand on these initial findings by modifying the outpatient approach for those patients with less favourable prognostic features, that is, patients will be stratified to differing therapies but with the majority still receiving the proven vinorelbine-gemcitabine combination.

Eligibility criteria:
inclusion criteria: * age \> 18 years * relapsed or primary refractory non-hodgkin's lymphoma (nhl) or hodgkin's disease (hd) * ecog 0 - 2 * written informed consent exclusion criteria: * intention to proceed with any form of transplant therapy following fewer than 2 cycles of protocol salvage therapy * bilirubin \> 50μmol/litre unless secondary to lymphoma * creatinine \> 2 x upper limit of normal unless secondary to lymphoma, absolute neutrophil count \<0.5 x 109/litre and / or platelets \< 50 x 109/litre unless secondary to lymphoma * relapse within 6 months of a prior transplant procedure (autologous or allogeneic) * known sensitivity to e coli derived preparations

Keywords: lymphoma
an observational study of roactemra/actemra (tocilizumab) in combination with methotrexate in patients with rheumatoid arthritis (activate)

Conditions: Rheumatoid Arthritis

Summary: this observational study will evaluate the safety, tolerability and efficacy of roactemra/actemra (tocilizumab) in combination with methotrexate in patients with moderate to severe rheumatoid arthritis. data will be collected for 12 months from patients initiated on treatment with roactemra/actemra (8 mg/kg intravenously every 4 weeks) and methotrexate (weekly dose at the discretion of the physician).


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * moderate to severe rheumatoid arthritis * roactemra/actemra treatment initiated by rheumatologist in an arthritis center for (up to 2 months prior to study entry) exclusion criteria: * history of severe allergic or anaphylactic reactions or known hypersensitivity to any component of the drug * active, severe infection or history of recurrent clinically significant infection * pregnancy * treatment with an investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before baseline visit * methotrexate intolerance
a study of glycemic control in left ventricular assist

Conditions: Type 2 Diabetes Mellitus; Hyperglycemia; Hypoglycemia

Summary: the study is being conducted to understand if the hemoglobin a1c, a measurement of control of blood sugars over a 3-month time, is valid in patients with left ventricular assist devices (lvads) in place. to understand whether it is an adequate measurement, the investigators will compare the a1c to results from a continuous glucose monitor (cgm) measurement of blood sugars. by monitoring blood sugars continuously, the investigators will also assess whether they can get better control of blood sugars with a cgm, including avoiding low blood sugars.


Eligibility criteria:
inclusion criteria: * prior implantation of contemporary, centrifugal flow lvad (heartware or heartmate 3) at any time after 2010 * diagnosis of type ii diabetes mellitus * any antihyperglycemic regimen * greater than 3 months out from lvad implantation * capable of utilizing smartphone device for librelink app for uploading glycemic data * patients may be enrolled who have preexisting cgm in place. exclusion criteria: * type i diabetics * unable to return at 3 month evaluation * unwillingness to participate

Keywords: left ventricular assist device (lvad)
product surveillance registry; ear, nose and throat - extend cohort

Conditions: Chronic Rhinosinusitis (CRS)

Summary: the purpose of this study is to confirm long-term clinical safety and performance, acceptability of identified risks, and detect emerging risks based on factual evidence for the propel family of products when used according to labeling in a real-world setting.

ongoing clinical investigation for the purpose(s) of: * providing continuing evaluation and periodic reporting of safety and effectiveness of medtronic market-released products for their intended use * obtaining real-world performance and safety information from a global network of hospitals, clinics, and clinicians intended to represent the range of clinical environments in which medtronic products are used * supporting post-market surveillance activities and post-approval studies that are initiated by medtronic, regulated by local governments, or are conducted to fulfill government and/or regulatory authority requests * obtaining clinical evidence to guide the development and improvement of medical devices, therapies, device guidelines, and patient services/solutions * providing clinical data to support health economics and clinical outcomes research enrollment is estimated to take place at up to 10 sites in europe over 12 months. a single site may enroll no more than 30 patients. patients may be enrolled up to 60 days prior to the baseline procedure. subjects will be followed for a total duration of12 months postoperatively.

Eligibility criteria:
inclusion criteria: * patient or legally authorized representative (lar) provides authorization and/or consent per institution and geographical requirements. * patient has or is intended to receive or be treated with an eligible medtronic product * patient is consented within the enrollment window of the therapy received, as applicable exclusion criteria: * patient who is, or is expected to be, inaccessible for follow-up * participation is excluded by local law * patient is currently enrolled or plans to enroll in concurrent drug/device study that may confound the psr results

Keywords: propel corticosteroid-eluting sinus implants product surveillance registry ent propel mini propel contour
a study to evaluate the efficacy and safety of (d/c/f/taf) once daily fixed dose combination (fdc) regimen in newly diagnosed, antiretroviral treatment-naive human immunodeficiency virus type 1 (hiv-1) infected participants receiving care in a test and treat model of care

Conditions: HIV-1

Summary: the purpose of this study is to assess the efficacy of darunavir/ cobicistat/ emtricitabine/ tenofovir alafenamide (d/c/f/taf) fixed-dose combination (fdc) in a test and treat model of care in newly diagnosed human immunodeficiency virus (hiv-1)-infected, treatment-naive participants as determined by the proportion of virologic responders defined as having (hiv)-1 ribonucleic acid (rna) lesser than 50 copies per milliliter (copies/ml) at week 48.


Eligibility criteria:
inclusion criteria: * newly diagnosed with human immunodeficiency virus type 1 (hiv-1) evidenced by any of the following within 2 weeks of the screening/baseline visit: a) hiv rapid antibody positive; or b) hiv immunoassay positive; or c) positive p24 antigen and a hiv-1 ribonucleic acid (rna) viral load greater than or equal to (\>=) 5,000 copies per milliliter (copies/ ml); or d) non-reactive hiv-1 antibody/antigen assays and hiv-1 rna viral load (\>=) 5,000 copies/ml. hiv-1 rna viral load must be confirmed once within 1 week of initial hiv-1 rna viral load test * antiretroviral treatment-naïve, except for the use of truvada® for pre-exposure prophylaxis (prep) * must be able to swallow whole tablets * a woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 90 days after receiving the last dose of study drug * a woman of childbearing potential must have a negative urine pregnancy test at screening exclusion criteria: * known active cryptococcal infection, active toxoplasmic encephalitis, mycobacterium tuberculosis infection, or another acquired immunodeficiency syndrome (aids) -defining condition that in the judgement of the investigator would increase the risk of morbidity or mortality * known history of clinically relevant hepatic disease or hepatitis that in the investigator's judgement is not compatible with darunavir/ cobicistat/ emtricitabine/ tenofovir alafenamide (d/c/f/taf fdc) * known history of cirrhosis as diagnosed based on local practices * known history of chronic (\[\>=\] 3 months) renal insufficiency, defined as having an estimated glomerular filtration rate (egfr) less than (\<) 50 milliliter per minute (ml/min) according to the modification of diet in renal disease (mdrd) formula * pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 90 days after the last dose of study treatment
sublingual vs vaginal misoprostol for termination of first trimesteric missed abortion

Conditions: Missed Abortion

Summary: efficacy of sublingual versus vaginal misoprostol in termination of first trimester missed abortion

study will be made on female patients with first trimester missed abortion confirmed by ultrasound . participants will be divided into 2 groups one group (a) will receive sublingual misoprostol and the other group(b) will receive vaginal misoprostol as a 800 micro grams every 4 hours in both groups up to five doses the aim of the study is to compare efficay of sublingual and vaginal misoprostol in complete termination of first trimester missed abortion and which route is the best will less side effects.

Eligibility criteria:
inclusion criteria: * women with an ultrasound diagnosis of missed abortion \< 13 weeks gestation without any clinical criteria of inevitable abortion. exclusion criteria: * patients refused the medical treatment. * patients have contraindications of the drug (misoprostol). * missed abortion associated with any signs of sepsis
a hybrid type 2 trial of trauma-focused cognitive behavioral therapy and a pragmatic individual-level implementation strategy

Conditions: Evidence-Based Practices; CBT; School Health Services; Trauma, Psychological

Summary: this research project is a hybrid type 2 effectiveness-implementation trial that simultaneously examines (1) the effectiveness of a trauma-focused intervention for youth in the education sector and (2) the impact of a theory-driven pragmatic implementation strategy designed to increase the adoption, fidelity, and sustainment of evidence-based treatments (ebts). this trial will include 120 clinicians and 480 students, and it is designed to test the cost effectiveness and impact of trauma-focused cognitive behavioral therapy (tf-cbt) in a new setting that increases access to mental health care - schools (aim 1); test the cost effectiveness, immediate impact, and sustained impact of the beliefs and attitudes for successful implementation in schools (basis) implementation strategy on proximal mechanisms and implementation outcomes (aims 2a, 2b, 2d); and conduct sequential mixed-methods data collection to explain residuals (i.e., clinicians whose implementation behavior is unaccounted for by the mediation model) (aim 2c).


Eligibility criteria:
clinicians will be included if they (a) provide school-based services in a participating district; (b) have not previously received formal training in tf-cbt; and (c) are not actively receiving support to implement another trauma-focused intervention. students subjects will meet tf-cbt eligibility criteria, including (a) be within the tf-cbt developmental range (grades 3 -12), (b) have traumatic event exposure (e.g., exposure to violence), and (c) significant post-traumatic stress symptoms.
clinical trial on the effectiveness of traditional chinese medicinal mixture in parkinson disease

Conditions: Parkinson Disease

Summary: this study was designed to evaluate the symptomatic effects or potential disease progression slowing down effect of a kind of traditional chinese medicinal mixture in parkinson's disease (pd) patients. the treatment phase includes 12 months period of traditional chinese medicinal mixture per day or placebo and 1 month wash-out period without herbal medicine and placebo.

the design of the study was a prospective, randomized, multicenter, double-blind placebo-controlled protocol. the intervention includes traditional chinese medicinal mixture tid or matched placebo. participating study centers include neurological university outpatient clinics and neurological departments of community-based hospitals experienced with pd patients. the primary outcome measure was the combined unified parkinson's disease rating scale (updrs). the hypothesis of this study was that traditional chinese medicinal mixture improves the overall wellbeing of pd patients and thus may leads to an improvement of parkinsonian symptoms in pd patients.

Eligibility criteria:
inclusion criteria: * parkinson's disease according to the uk brain bank criteria * hoehn \& yahr stadium ⅰ～ⅲ * age over 50 years * taking only levodopa and/or dopamine agonists when recruiting * consistent with the liver kidney deficiency type by traditional chinese medicine (tcm) standard * patients voluntarily take part in this study and signed the informed consent exclusion criteria: * modified hoehn-yahr scale are higher than 4 * had other serious illness such as liver/kidney failure, serious infection etc * allergic to the study drug * had been participated in other clinical trials during the last 3 months prior to study inclusion. * taking coenzyme q10, mao-b inhibitors, or vitamin e, all of which might improve the symptom or slowdown the progression of pd. * taking herbal medicine that can nourish the liver and kidney by tcm standard. * had serious mental disorder and could not describe his/her symptom.
potential environmental causes of uveal coloboma

Conditions: Coloboma

Summary: background: uveal coloboma is a congenital eye malformation. it is thought to be a genetic condition. but it might have environmental causes as well. researchers want to study the mothers of children with coloboma. they will use parts of the national birth defects prevention study (nbdps) mother questionnaire. nbdps was a large study of birth defects. it collected data from 1997 to 2011. researchers will use nbdps and nih data as well as the new survey to produce data that can serve as a basis for further study. objective: to explore maternal factors and exposures during the first trimester of pregnancy as potential causes of uveal coloboma and to correlate exposure data to clinical data from affected children. eligibility: mothers of probands with coloboma who have taken part in nih study 06-ei-0230, 04-ei-0039, or 13-ei-0049. design: this is a hybrid study. it will use existing data from nbdps and nih studies. it will also use nbdps for a new survey of mothers of children with coloboma. participants will take the survey by phone. their pregnancy records may be reviewed. they will be asked about: important dates health and medicines tobacco, alcohol, and substance use parents occupations family demographics. the survey will take 1 hour or less to complete. some data were obtained in past nih studies. these data are largely from children. some family data may be used as well. for example, eye exam data, gene test results, and family history of coloboma may be used. if a participant did not consent to the future use of their data, then their data will not be used. data will be stored in a secure nih database. ...

study description: this evaluation of potential environmental causes of coloboma explores the experiences of a large cohort of mothers of children with uveal coloboma using portions of the national birth defects prevention study (nbdps) mother questionnaire. it is postulated that maternal hypothyroidism and in utero alcohol exposure are found at higher rates in this cohort than in rates found in the general population. the goal is to produce descriptive statistic that could serve as a basis for further epidemiologic studies. objectives: the primary objective is to explore maternal factors and exposures during the first trimester of pregnancy as potential causes of uveal coloboma and to correlate these exposures with the clinical presentation of the affected child/children.

Eligibility criteria:
* inclusion criteria: * mothers of probands with coloboma that have previously been consented to an nih protocol studying coloboma.

Keywords: questionnaire microphthalmia birth defects natural history