Kornimate/medical-research-clean huggingface dataset:
alcohol misuse, gut microbial dysbiosis and prep care continuum: application and efficacy of sbirt intervention

Conditions: Alcohol Use Disorder; Risk Behavior, Health; Dysbiosis; HIV Infections

Summary: this randomized control trial study among pre-exposure prophylactic users (prep) aims to learn and determine the efficacy of screening, brief intervention, and referral to treatment (sbrit) in reducing the risk of alcohol use. the main questions it aims to answer are: 1. how alcohol use impacts the prep continuum and to understand how early intervention and treatment approach affects alcohol use and prep adherence. 2. investigate the effectiveness of the sbirt intervention in preventing hazardous alcohol use and its impact on gut dysbiosis in prep users. 3. to determine alterations in the gut microbiome (dysbiosis), intestinal homeostasis, systemic inflammation, and markers of liver disease associated with hazardous alcohol use among prep users.

the study pursues a randomized control trial (rct) with persons who use pre-exposure prophylaxis (prep) to determine the efficacy of sbirt (screening, brief intervention, \& referral to treatment) in reducing the risk of alcohol drinking and associated pathogenic changes in the gut liver axis. participants in this study will attend visits at 3 months, 6 months,s and 12 months for about 60 to 90 minutes. these visits may include filling out a survey, participating in an interview, meeting with an sbirt interventionist, and providing the aforementioned samples: blood, urine, stool, saliva, oral and vaginal, if applicable. this study will use a syndemic approach to expand the hiv/aids prevention toolkit among populations impacted by alcohol with a range of patterns of episodic and long-term use and associated behavioral and biological risks for hiv acquisition. specifically, the team will execute a randomized control trial among pre-exposure prophylaxis (prep) users demonstrating heightened alcohol use to test the effectiveness of the screening, brief intervention, \& referral to treatment (sbirt) intervention to reduce alcohol use and examine the subsequent impact on the gut microbiome compared to individuals receiving treatment as usual and prep users not demonstrating elevated alcohol use. finally, we will employ qualitative methods (in-depth interviews) and analysis to understand decision-making factors influencing prep adherence and alcohol use over time.

Eligibility criteria:
inclusion criteria: * age: 18-85 years * confirmation of seronegative hiv, hep b, and hep c status * prep users * english-speaking or spanish speaking * cognitively competent to provide consent * attend a participating healthcare facility exclusion criteria: * inability to consent * existing diagnosis of major psychiatric illness * unstable medical conditions (e.g., cancer) * taking immunosuppressants or chemotherapy * taking daily antibiotics or probiotics * severe gastrointestinal/liver disease * autoimmune disease

Keywords: prep alcohol sbirt
a phase ii clinical trial to evaluate hlx208 in advanced non-small cell lung cancer patients with braf v600 mutation

Conditions: NSCLC

Summary: evaluate the efficacy，safety and pharmacokinetics of hlx208 in advanced non-small cell lung cancer patients with braf v600 mutation


Eligibility criteria:
inclusion criteria: * age\>=18y * good organ function * expected survival time ≥ 3 months * advanced braf v600 nsclc that have been diagnosed histologically or cytology and have failed standard treatment or unable to receive, or refusing standard care. * previous failure to standard treatment, or insuitability for standard treatment or refuse standard treatment. * ecog score 0-2; * exclusion criteria: * previous treatment with braf inhibitors or mek inhibitors * presence of egfr mutations or alk rearrangements (unless disease progression following prior treatment with tyrosine kinase inhibitors). * symptomatic brain or meningeal metastases (unless the patient has been on \> treatment for 1 months, has no evidence of progress on imaging within 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable). * current or former patients with interstitial lung disease; * severe active infections requiring systemic anti-infective therapy * a history of other malignancies within two years, except for cured cervical carcinoma in situ, basal cell carcinoma of the skin, adenocarcinoma in situ of the lung, or tumors that do not require interventional treatment after radical surgery. * other anti-tumor treatments, such as chemotherapy, targeted therapy, or radiation therapy (except palliative radiation therapy), may be given during the study period.
a study to examine the effects of pf-04958242 on ketamine-induced cognitive impairment in healthy volunteers

Conditions: Schizophrenia

Summary: to assess if pf-04958242 can attenuate the ketamine-induced cognitive impairment in verbal learning and memory, episodic memory and spatial working memory in healthy volunteers.

this study was previously posted by pfizer, inc. sponsorship of the trial was transferred to biogen.

Eligibility criteria:
inclusion criteria: * healthy male subjects 21 - 45 years old. * able to read and write english as primary language. * subjects who are willing to comply with study procedures. exclusion criteria: * history of any substance abuse or dependence disorder meeting dsm-iv criteria and/or by scid-np within the past 12 months, with the exception of nicotine. * known sensitivity to ketamine * any history of dsm-iv axis i psychiatric disorders, determined by scid-np interview or diagnoses in the view of the investigator.

Keywords: pf-04958242 ketamine cognition healthy volunteers
effect of thyrotropin level on iodine uptake in metastatic differentiated thyroid cancer

Conditions: Differentiated Thyroid Cancer

Summary: distant metastases is the leading cause of differentiated thyroid cancer-related death. radioactive iodine (rai) treatment is the most effective therapy for rai-avid metastatic differentiated thyroid cancer (dtc). it is well known that the efficacy of rai therapy is depend on the sodium-iodide symporter protein, which can be synthesized by elevated thyrotropin stimulation. therefore, thyrotropin stimulation before rai treatment to ensure sufficient uptake of rai has been a long-established procedure. according to some observational studies, thyrotropin of 25-30 μiu/ml has been adopted as the standard care protocol. however, whether thyrotropin of 25-30 μiu/ml is enough to stimulate iodine uptake in metastatic lesions remains unknown. in this study, the investigators aim to address the effect of thyrotropin on iodine uptake in metastatic dtc during levothyroxine withdrawal by two times 124i pet/ct scans on different endogenous thyrotropin levels.

it is estimated that 10 patients who met the study criteria will be enrolled. all patients underwent twice 124i pet/ct scans in beijing cancer hospital. the first 124i pet/ct was prepared with endogenous thyrotropin 30±10 μiu/ml, the second 124i pet/ct was prepared with endogenous thyrotropin \>100 μiu/ml. the rai-avidity of the metastases was assessed twice along with the levothyroxine withdrawal by 124i pet/ct scans.

Eligibility criteria:
inclusion criteria: 1. patients underwent total thyroidectomy. 2. patients were diagnosed with differentiated thyroid cancer by postoperative pathological examination. 3. distant metastases confirmed by ct etc. exclusion criteria: 1. pregnancy or lactation. 2. significant hepatic or renal dysfunction; 3. unable to lie flat, still or tolerate a pet scan.

Keywords: differentiated thyroid cancer pulmonary metastases bone metastases thyrotropin thyroid stimulating hormone 124i pet/ct
safety, tolerability, pharmacokinetics and pharmacodynamics of apl180

Conditions: Coronary Heart Disease

Summary: the design of this study will enable an extensive evaluation of safety, tolerability, and pk-pd relationship following 4 weeks of dosing in patients with coronary heart disease


Eligibility criteria:
inclusion criteria: * male and female chd or chd equivalent patients * body mass index (bmi) must be within the range of 20 to 35 kg/m2, * patient must have been on a stable statin therapy for \>8 weeks prior to first dose except for the statin intolerant patients. exclusion criteria: * pregnancy * significant illness within two weeks prior to dosing. * triglycerides ≥ 500 mg/dl (5.65 mmol/l) * uncontrolled hypertension * any condition that in the opinion of the investigator or the novartis medical monitor would jeopardize the evaluation of efficacy or safety. * presence of nyha class iii or iv chronic heart failure * mi or angioplasty (including stenting), acute coronary syndrome (acs), unstable angina or arterial embolic disease within 6 months prior to do other protocol-defined inclusion/exclusion criteria may apply

Keywords: coronary heart disease apl180
toviaz post marketing surveillance study

Conditions: Overactive Bladder

Summary: the objective of this study is to determine the problems and questions of safety and efficacy of toviaz® under the standard conditions of usage.

continuous registration method

Eligibility criteria:
inclusion criteria: * subjects who are diagnosed as overactive bladder (oab) defined as urgency, with or without urgency incontinence, usually with frequency and nocturia, in the absence of local or metabolic factors explaining these factors. exclusion criteria: * hypersensitivity to the active substance or to peanut or soya or any of the excipients * urinary retention * gastric retention * uncontrolled narrow angle glaucoma * myasthenia gravis * severe hepatic impairment (child pugh c) * concomitant use of potent cyp3a4 inhibitors in subjects with moderate to severe hepatic or renal impairment * severe ulcerative colitis * toxic megacolon * patients with rare hereditary problems of galactose intolerance, the lapp lactase deficiency or glucose-galactose malabsorption (toviaz® prolonged-release tablets contain lactose)
turkish adaptation and psychometric properties of fugl-meyer assessment in acute stroke patients

Conditions: Stroke, Acute; Cerebrovascular; Disorder, Acute

Summary: the aim of this methodological study is to adapt the fugl-meyer assessment to turkish culture and to test its validity and reliability in acute phase stroke patients.

according to the definition of the world health organization, stroke is a clinical syndrome that causes rapid focal (or global) cerebral function loss for no apparent reason other than vascular causes, and symptoms persist for more than 24 hours or lead to death. to effectively manage the post-stroke processes and establish an effective treatment plan, a comprehensive assessment is necessary. one of the most common motor problems following a stroke is hemiplegia, which makes it challenging for the patient to perform activities of daily living and ambulation. understanding the mechanisms of motor control and motor learning, which are vital components of stroke rehabilitation, necessitates the assessment of motor function. for evaluating motor function in stroke patients, there are numerous outcome measures available. the fugl-meyer assessment (fma) stands out when comparison of these assessments in terms of clinical and psychometric values. there is no official fma version that has been translated into turkish, even though fugl-meyer assessment is used in numerous research in turkey. the aim of this study is to adapt the fugl-meyer assessment to turkish culture and to test its validity and reliability in acute stroke patients.

Eligibility criteria:
inclusion criteria: * patients who diagnosed with stroke * less than 1 month passed after onset of stroke * upper and lower extremity motor involvement between brunnstrom stages 2 and 5 * voluntarily accepting to participate in this research exclusion criteria: * visual and hearing impairment * upper or lower extremity amputation * significant cognitive impairment (mini mental state test score \< 18) * mental disorders affecting daily life functioning * global aphasia * other unstable conditions that may affect participation

Keywords: acute stroke fugl-meyer assessment upper extremity lower extremity outcome assessment stroke rehabilitation translation and cross-cultural adaptation validity reliability
ultrasonic measurement of the area of the anterior superior labrum of the hip joint for diagnosis of labrum tear

Conditions: Acetabular Labrum Tear

Summary: in this study, ultrasound diagnosis was performed for patients with hip joint anterior superior labrum tear, and the final surgical observation was used as the gold standard to evaluate the diagnostic efficacy of ultrasonic measurement of the hip joint anterior superior labrum area in the diagnosis of labrum tear.

in this study, ultrasound diagnosis was performed for patients with a torn anterior superior labrum of the hip joint, and the final surgical observation was the gold standard. the control group selected patients with non-hip joint reasons to come to the ultrasound department of our hospital for diagnosis at the same time. both the case group and the control group were included in the study at a rate of 1.1 times. this study plans to include 149 cases in the case group and 297 cases in the control group. this study was used to evaluate the diagnostic efficacy of ultrasonic measurement of the area of the anterior superior labrum of the hip in the diagnosis of labrum tears.

Eligibility criteria:
inclusion criteria: case group inclusion criteria (1) age is greater than or equal to 18 years old (2) patients with preoperative ultrasound examination for clinically planned hip joint anterior superior labrum tear (3) the patient can understand and sign the informed consent form control group inclusion criteria 1. age is greater than or equal to 18 years old 2. patients who come to the ultrasound department of our hospital for treatment of non-hip joints at the same time 3. the patient can understand and sign the informed consent form exclusion criteria: case group exclusion criteria 1. mental conditions are not allowed 2. adhesives that are allergic to any known control group exclusion criteria (1) mental conditions are not allowed (2) adhesives that are allergic to any known (3) past and current diseases of other hip joint diseases
a study of multiple immunotherapy-based treatment combinations in participants with metastatic non-small cell lung cancer (morpheus- non-small cell lung cancer)

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: this study will evaluate the efficacy, safety, and pharmacokinetics of immunotherapy-based treatment combinations in participants with metastatic non-small cell lung cancer (nsclc). two cohorts will be enrolled in parallel in this study: cohort 1 will consist of participants with tumor pd-l1 expression who have received no prior systemic therapy for metastatic nsclc, and cohort 2 will consist of participants who experienced disease progression during or following treatment with a platinum-containing regimen and a pd-l1/pd-1 checkpoint inhibitor, given in combination as one line of therapy or as two separate lines of therapy, regardless of pd-l1 expression. in each cohort, eligible participants will initially be assigned to one of several treatment arms (stage 1). participants who experience disease progression, loss of clinical benefit, or unacceptable toxicity during stage 1 may be eligible to continue treatment with a different treatment regimen (stage 2).


Eligibility criteria:
general inclusion criteria * eastern cooperative oncology group (ecog) performance status of 0 or 1 * life expectancy greater than or equal to 3 months * histologically or cytologically confirmed metastatic, non-squamous or squamous non-small cell lung cancer (nsclc) * measurable disease (at least one target lesion) * adequate hematologic and end-organ function * tumor accessible for biopsy * for women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating eggs as outlined for each specific treatment arm * for men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as outlined for each specific treatment arm inclusion criteria for cohort 1 * no prior systemic therapy for metastatic nsclc * high tumor pd-l1 expression, defined as tumor proportion score (tps) or tcs \>= 50% or tc3 inclusion criteria for cohort 2 - disease progression during or following treatment for metastatic or locally advanced, inoperable nsclc exclusion criteria * prior allogeneic stem cell or solid organ transplantation * uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) * symptomatic, untreated, or actively progressing central nervous system (cns) metastases * history of leptomeningeal disease * active or history of autoimmune disease or immune deficiency * history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan * history of malignancy other than nsclc within 2 years prior to screening * active tuberculosis * severe infection within 4 weeks prior to initiation of study treatment
robotic-assisted vs. open partial nephrectomy

Conditions: Renal Cell Carcinoma

Summary: robocop is an open-label, randomized controlled feasibility trial comparing robotic-assisted and open partial nephrectomy in preparation for a confirmative phase iii randomized controlled trial.

surgical excision is the gold standard for the treatment for localized kidney cancer. an organ-preserving procedure should be carried out whenever possible in order to maintain kidney function. partial nephrectomy can be performed through the conventional open technique as well as through a robotic-assisted approach. although both methods belong to the standard care, there is still no published data from randomized controlled trials in the scientific literature comparing them. the robocop-trial is designed as a single-center comparison of the two surgical approaches in preparation for a phase iii study. 50 patients are to be included in the trial within a period of 15 months. the primary endpoint is feasibility of patient recruitment. in addition, potential primary outcomes for a confirmative trial such as perioperative complications, quality of life, inflammatory response, survival and ergonomic aspects for the operating surgeons will be investigated.

Eligibility criteria:
inclusion criteria: * scheduled for elective partial nephrectomy for renal neoplasms * patient must be at least 18 years old and capable to consent * abdominal mri or ct scan * curative-intent surgery * robotic-assisted and open approach for surgery are both feasible * ability of patient to understand the goal, consequences and alternatives of participation in the trial * written informed consent exclusion criteria: * patients with solitary kidney * multiple kidney tumors * emergency intervention, for example because of bleeding or perforation * 2nd malignancy that will make pn needless, this does not include secondary malignancies which are under curative treatment or cases in which death from rcc is more likely * patient belongs to a vulnerable patient group * simultaneous 2nd surgery
onsite tobacco cessation treatment for patients with pad

Conditions: Tobacco Cessation; Peripheral Artery Disease

Summary: tobacco cessation treatment is needed for individuals with peripheral artery disease (pad) to improve symptoms, lower cardiovascular risk, and prevent amputation. while such treatment is effective, many pad patients do not receive cessation therapy. participants will receive nicotine replacement therapy, counseling, and and complete questionnaires. we hypothesize that integrating tobacco cessation services into a dedicated pad clinic (ou cvi limb preservation clinic) can improve tobacco cessation rates and improve pad-related health outcomes in this at risk population.


Eligibility criteria:
inclusion criteria: * have diagnosed peripheral artery disease * tobacco user * 18 years of age or older * willing/able to attend all study visits * be able to read, speak, and understand english exclusion criteria: * do not meet the specified inclusion criteria above
amg 757 and amg 404 in subjects with small cell lung cancer (sclc)

Conditions: Small Cell Lung Cancer

Summary: the main purpose of this study is to evaluate the safety, tolerability, and recommended phase 2 target dose of tarlatamab in combination with amg 404.


Eligibility criteria:
inclusion criteria: * participant has provided informed consent/assent prior to initiation of any study specific activities/procedures * age greater than or equal to 18 years old at the same time of signing the informed consent * participants with histologically or cytologically confirmed small cell lung cancer (sclc) who progressed or recurred following at least 1 platinum-based regimen * eastern cooperative oncology group (ecog) 0 to 1 * participants with treated brain metastases are eligible provided they meet defined criteria * adequate organ function as defined in protocol exclusion criteria: * history of other malignancy within the past 2 years with exceptions * major surgery within 28 days of first dose of tarlatamab * untreated or symptomatic brain metastases and leptomeningeal disease * prior anti-cancer therapy, including anti-pd1 or anti-pdl1 antibody therapy: at least 28 days must have elapsed between any prior anti-cancer therapy and the first planned dose of tarlatamab exceptions: * participants who received prior chemotherapy must have completed at least 14 days before the first dose of tarlatamab and all treatment-related toxicity resolved to grade ≤ 1. * participants who received prior palliative radiotherapy must have completed at least 7 days before the first dose of tarlatamab * participants who received prior tarlatamab therapy or prior delta-like ligand 3 (dll3) x cluster of differentiation 3 (cd3) bispecific therapy are not eligible * participants who experienced recurrent grade 2 pneumonitis or severe or life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents * history of any immune-related colitis. infectious colitis is allowed if evidence of adequate treatment and clinical recovery exists and at least 3 months interval observed since diagnosis of colitis * participants with evidence of interstitial lung disease or active, non-infectious pneumonitis * has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of tarlatamab * history of solid organ transplantation * history of hypophysitis or pituitary dysfunction * active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study. participants with type i diabetes, vitiligo, psoriasis, hypo- or hyper-thyroid disease not requiring immunosuppressive treatment are permitted

Keywords: small cell lung cancer sclc lung cancer amg 757 amg 404 tarlatamab