Kornimate/medical-research-clean huggingface dataset:
lenvatinib plus toripalimab for platinum-resistant recurrent ovarian cancer

Conditions: Recurrent Ovarian Carcinoma

Summary: the investigators propose to initiate a study assessing the efficacy and safety of a lower initial dosage of lenvatinib combined with toripalimab in patients suffering from platinum-resistant recurrent ovarian cancer. the objective of this research is to offer a novel therapeutic approach for patients battling relapsed ovarian cancer with platinum resistance.


Eligibility criteria:
inclusion criteria: 1. age: 18 to 75 years; 2. platinum-resistant recurrence of epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. 3. according to the recist 1.1 criteria, there should be at least one measurable lesion or a ca 125 level of ≥ 70 iu/l. 4. ecog 0-2； 5. liver and kidney function: serum creatinine levels should be ≤ 1.5 times the upper limit of the normal range.ast and alt levels should be ≤ 2.5 times the upper limit of normal, or ≤ 5 times the upper limit of normal if liver metastases are present;total bilirubin should be ≤ 1.5 times the upper limit of the normal range. 6. participants of reproductive age must consent to the use of effective contraceptive methods throughout the duration of the study.women of reproductive age must yield a negative result in serum or urine pregnancy tests.non-lactating patients. 7. those who are expected to survive longer than 3 months. patients were unconscious and volunteered to participate in the study. exclusion criteria: 1. uncontrollable malignant hypertension; 2. imaging showed that the tumor invaded important blood vessels; 3. contraindications to the use of antiangiogenic agents; 4. contraindications to checkpoint inhibitors; 5. patients presenting with abdominal fistula, gastrointestinal perforation, and pelvic-abdominal abscess; 6. simultaneous involvement or engagement in another clinical trial within a one-month period that could potentially influence the outcomes of this study. 7. known hypersensitivity to study-related drugs or their excipients; 8. individuals with severe heart, liver, kidney, and other serious concurrent diseases that may pose a threat to life; 9. patients judged by the investigator to be inappropriate for participation in the study.
optimizing active surveillance in low-risk prostate cancer: a pilot study

Conditions: Prostate Cancer

Summary: this is a pilot evaluation of a patient-centered intervention that enables providers to support men on active surveillance to maximize adherence. conducted in urology practices, this pilot will measure key patient-reported, provider-reported, and implementation outcomes. successful completion of this work will inform a subsequent multi-center effectiveness-implementation hybrid design trial and ultimately will improve low-risk cancer management by effectively engaging primary care physicians (pcps) in care delivery.


Eligibility criteria:
patient inclusion criteria: * 55 years old or older * men diagnosed with low-risk prostate cancer currently on active surveillance * men who identify having a primary care provider * access and ability to use the internet patient exclusion criteria: * men who are unable to read and/or speak english * men with impaired decision-making capacity (such as with a diagnosis of dementia or memory loss) pcp inclusion criteria: * identified by patient on baseline survey as their pcp urologist and clinic staff inclusion criteria: * clinicians or staff at a participating urology clinic, including but not limited to mds, apps, and nurses

Keywords: low-risk active surveillance
med3000 topical gel for on-demand treatment of post-radical prostatectomy erectile dysfunction

Conditions: Erectile Dysfunction Following Radical Prostatectomy

Summary: the investigators are doing this research to evaluate the efficacy and safety of topical med3000 therapy in men with persistent erectile dysfunction 1.5 to 4 years following radical prostatectomy surgery.

med3000 is a topical gel that has been developed to treat patients with erectile dysfunction. the investigators postulate that on demand treatment with med3000 can improve on-demand erectile function among men status-post radical prostatectomy, allowing for some endogenous cavernosal nerve function recovery for 1.5 to 4 years post-surgery among men with normal baseline pre-surgical erectile function.

Eligibility criteria:
inclusion criteria: * men who underwent robotic bilateral nerve-sparing radical prostatectomy between 18 and 36 months prior to study commencement * subjects are 18-48 months status-post radical prostatectomy * subjects have any degree of erectile dysfunction based on iief questionnaire * age 40 - 70 at study commencement * diagnosed with low/intermediate-risk prostate cancer: * psa \< 20 ng/ml * gleason score =\< 8 * prostate cancer stage =\< t3a * normal pre-radical prostatectomy erectile function (iief \>=26) or equivalent response on epic * baseline erectile dysfunction at time of screening (despite use of erectogenic aids of any kind) and enrolment following washout (iief-ed domain \<=25) * sexually active, in a stable heterosexual relationship for at least 6 months prior to screening * able to understand and complete patient questionnaires * serum prostate specific antigen (psa) undetectable (no evidence of disease recurrence) * able to consent to participate * documented written informed consent from both patient and his female partner exclusion criteria: * anatomical abnormalities in the genitalia or pelvic region such as severe phimosis * post-radical prostatectomy complications that could impact safety or effectiveness of medical therapy for erectile function (treatment for pelvic hematoma, urinary or intestinal fistula, unresolved anastomotic leak) * tumor upstaging beyond t3a * incomplete / sub-total nerve sparing on either side * previous or scheduled treatment with pelvic salvage radiotherapy and/or androgen deprivation therapy * prior receipt of androgen deprivation therapy * any other condition that would prevent the patient from completing the study, as judged by the principal investigator
effect of arterial oxygen partial pressure on mixed venous oxygen saturation

Conditions: Anemia

Summary: mixed venous oxygen saturation is known to reflect oxygen delivery and, thus, is frequently monitored in patients undergoing cardiac surgery. factors that affect mixed venous oxygen saturation include hemoglobin level, arterial oxygen saturation and arterial oxygen partial pressure. among them, arterial oxygen partial pressure is known to have minimal effect on oxygen delivery compared to hemoglobin and arterial oxygen saturation. however, some argues that in certain clinical setting, such as anemia which is very common in cardiac surgery patients, the contribution of plasma (arterial oxygen partial pressure in this case) to oxygen delivery becomes more significant. therefore, we planned to perform a pilot clinical trial to observe the change of oxygen delivery, which would be reflected in mixed venous oxygen saturation and cerebral regional oxygen saturation, according to hemoglobin level.


Eligibility criteria:
inclusion criteria: * patients that scheduled to undergo cardiac surgery using cardiopulmonary bypass. exclusion criteria: * emergent surgery * symptomatic carotid artery stenosis or carotid artery stenosis of ≥50% * preoperative oxygen therapy that is equivalent to the inspired oxygen fraction of 0.5.
modulating context generalization through transcranial direct current stimulation

Conditions: Anxiety and Fear

Summary: behavioral adaptation is particularly relevant to anxiety and related disorders, where exposure-based therapies rely on such adaptation as part of behavior therapy.. however, while initial fear reactions generalize easily across contexts, subsequent adaption of behavior through learning is context-specific. the primary goal of this study is to investigate whether transcranial direct current stimulation (tdcs) can be used to acutely impact generalization of subsequent learning across contexts in an experimental paradigm. as part of this study, participants will complete a clinical interview and questionnaires, as well as a computer task asking them to make choices between stimuli on the screen and during which they may or may not receive tdcs.


Eligibility criteria:
inclusion criteria: 1. primary diagnosis of an anxiety or related disorder, (defined as panic disorder, social anxiety disorder, generalized anxiety disorder, obsessive-compulsive disorder, and/or post-traumatic stress disorder); 2. aged 18-55; 3. ability to speak, read, write, and understand english sufficiently well to complete study procedures and provide informed consent; 4. stable psychiatric medication use for at least 6 weeks. exclusion criteria: 1. lifetime history of psychotic symptoms or bipolar disorder, 2. current substance use disorder; 3. acute suicidality or homicidality, 4. significant neurological disorder, 5. any problems that would interfere with study participation, significant or unstable medical disorders and tdcs-related contraindications (e.g., implanted metallic substances, pregnancy, holes in the skull, skin abnormalities under stimulation sites).
comparison of flexhd and alloderm outcomes in breast reconstructive surgery

Conditions: Breast Neoplasm

Summary: flexhd and alloderm are two common products used in breast reconstruction to hold tissue expanders and implants in place. there have been few chart review studies comparing outcomes between the two materials in breast reconstruction. these studies have determined there is no difference in complication rates between the two materials. however, there have never been any active studies to date. this study will serve as a randomized controlled trial comparing flexhd and alloderm. several outcomes will be measured based off of inclusion and exclusion criteria to determine if either product is more suitable for use in breast reconstruction. this will be performed by randomly assigning patients to receive either flexhd or alloderm. designated outcomes will be followed closely postoperatively. outcomes will be statistically analyzed to determine complication rates between flexhd and alloderm and thus which product is better to use in breast reconstruction.

flexhd and alloderm are two common products used in breast reconstruction to hold tissue expanders and implants in place. there have been few chart review studies comparing outcomes between the two materials in breast reconstruction. these studies have determined there is no difference in complication rates between the two materials. however, there have never been any active studies to date. this study will serve as a randomized controlled trial comparing flexhd and alloderm. several outcomes will be measured based off of inclusion and exclusion criteria to determine if either product is more suitable for use in breast reconstruction. this will be performed by randomly assigning patients to receive either flexhd or alloderm. designated outcomes will be followed closely postoperatively. outcomes will be statistically analyzed to determine complication rates between flexhd and alloderm and thus which product is better to use in breast reconstruction

Eligibility criteria:
inclusion criteria: * bmi\<30 * no prior breast radiation * no prior breast reduction * no diabetes mellitus (iddm and non-iddm) * non-smoker or quit \>6 weeks prior * no breast implants or prior breast implants * no inflammatory or autoimmune disorders * no current anticoagulation therapy * no current pregnant exclusion criteria: * bmi \> 30 * prior breast radiation * diabetes mellitus - iddm and non iddm * prior breast reduction * active smoker or recently quit \<6 weeks * prior breast implants * inflammatory/autoimmune condition (ex. lupus) * current anticoagulation therapy * pregnancy
looking beyond the immediate effects of lumbar spinal manipulation using pain pressure threshold in asymptomatic individuals

Conditions: Lumbar Spine Injury; Pain

Summary: the goal of this clinical trial is to test in the effects of pain pressure threshold (ppt) looking out to 30 minutes in the lumbar spine. the main question\[s\] it aims to answer are: • is there a difference between ppt from baseline, immediately after, or 30 minutes after compared to sham ultrasound control group? participants will be exposed to sham ultrasound or sidelying lumbar manipulation with between groups and within group comparisons of ppt at the posterior superior iliac spine up to 30 minutes following the intervention.


Eligibility criteria:
inclusion criteria: * asymptomatic individuals between the ages of 18-50 exclusion criteria: * current low back pain (lbp) * a history of low back pain lbp within the last three months * previous spinal surgery * rheumatological condition or neurological symptoms or conditions * recent ingestion of pain-relieving medications within the last 24 hours * a lumbar manipulation within three days prior to the exam * exhibited any contraindications to manipulation * positive findings during screening precautions
impact of an echographic algorithm on hemodynamic optimization in the first 4 days of septic shock management

Conditions: Shock, Septic; Hemodynamic Instability

Summary: fluid management is one of the key issues in the initial management of septic shock (ss). fluid overload and hypovolemia have been associated with increased mortality in several trials. transthoracic echocardiography (tte) and lung ultrasound are recommended for haemodynamic assessment in critically ill patients. however, the benefit of hemodynamic optimisation using echography has not been yet evaluated. the purpose of this multicenter, controlled, randomized trial is to assess the impact of an echocardiographic algorithm of hemodynamic optimization on fluid management in septic patients during the first 4 days of therapy.


Eligibility criteria:
all eligible patients will have a cardiac echocardiogram prior to inclusion for the sole purpose of eliminating special situations that are part of the non-inclusion criteria listed below. inclusion criteria * patient in an intensive care unit who develops septic shock on admission or during hospitalization, as defined by sepsis-3 criteria. * patient or trusted person / legal representative / family member / curator / guardian who has given free and informed consent and has signed the consent form or patient included in an emergency situation. * patient affiliated or beneficiary of a health insurance plan. * patient at least (≥) 18 years of age. exclusion criteria: * refusal of consent. * patient under court protection or guardianship. * moribund patient with a life expectancy of less than 48 hours. * non-echogenic patient. * cardiac tamponade. * infective endocarditis. * intracavitary thrombus. * dilated cardiomyopathy with lvef (left ventricular ejection fraction\<40%. * parturient or nursing patient.

Keywords: monitoring transthoracic echocardiography blood volume fluid management
study to assess long term safety of pazopanib

Conditions: Carcinoma, Renal Cell

Summary: this study was a rollover study to evaluate the long term safety of pazopanib and to continue to provide pazopanib to patients who participated in a gsk sponsored pazopanib study until pazopanib is available commercially.


Eligibility criteria:
key inclusion criteria: * participated or completed a gsk sponsored pazopanib study and remains eligible for continued treatment with pazopanib and lapatinib (if on combination therapy). * able to understand and provide written informed consent * women and men agree to use protocol specific birth control measures key exclusion criteria: * the subject has a treatment related serious adverse event that remains unresolved or unstable or had pazopanib permanently stopped in a previous study because of intolerate or because it was unsuccessful in treating your cancer * if you are pregnant or breast feeding * your doctor does not think you would be a good candidate for the study * poorly controlled high blood pressure * subject is unwilling or unable to follow the procedures outlined in the protocol.

Keywords: chronic administration monotherapy and combination therapies solid lapatinib (tykerb, tyverb) malignant tumor pazopanib gw786034 cancer safety
randomised trial of structured treatment interruption of haart in hiv-infected adults in abidjan (anrs 1269 trivacan)

Conditions: HIV Infections

Summary: interrupting haart during limited periods of time ("structured treatment interruption : sti") could entail benefits (better long term tolerance, lower drug-induced viral resistance, lower cost) but also concomitant risks (lower efficacy, higher drug-induced viral resistance). at present, the benefit/risk ratio of sti is unclear. several sti trials are in progress in industrialised countries. this trial aim at assessing the benefits and risks of two different sti strategies in west africa.

the objective of this study is to assess the non-inferiority of two strategies of structured treatment interruption (sti) of highly active antiretroviral treatment (haart) compared with a continuous haart. it's a multicentric open labeled randomised non-inferiority trial, which takes place in 5 health care centres in abidjan, the economic capital city of cote d'ivoire the trial was designed in two phases : 1. pre-randomisation phase : 840 haart-naive hiv-infected adults start the following continuous haart regimen: zidovudine-lamivudine in combination with * preferably efavirenz, for hiv-1 infected men, and hiv-1 infected women with an effective contraception and no history of nevirapine-containing p-mtct (prevention of mother to child transmission); * ritonavir-indinavir, for hiv-2 infected patients, women not desiring contraception, and women with a past history of p-mtct with nevirapine. 2. trial phase : after at least six months on continuous haart in the pre-randomisation phase, patients who meet success criteria (cd4 count over 350/mm3, undetectable viral load, absence of current opportunistic infection) are randomised into three arms : * arm 1: continuous haart (1 of 6 patients) * arm 2: fixed sti strategy (3 of 6 patients): immutable periods of 2 months on haart / 4 months off haart * arm 3: cd4-guided sti strategy (2 of 6 patients): unlimited interruption of haart, and then re-introduction/re-interruption guided by the evolution of the cd4 count. following the dsmb recommendation, the arm 3 has been discontinued in october 2005. the trial is continuing for patients in the arms 1 and 2.

Eligibility criteria:
inclusion criteria: * informed consent * 18 years old or more * cd4 count between 150 and 350 per mm3 (or cd4 percentage between 12.5 and 20 percent) * no past history of curative antiretroviral therapy * residence in abidjan exclusion criteria: * pregnancy * severe renal failure * severe hepatic failure * severe neuropsychiatric disease

Keywords: hiv structured treatment interruption haart sub-saharian africa treatment interruption treatment naive
screening strategy for gastric cancer prevention

Conditions: H. Pylori Infection

Summary: there are still some unsolved questions regarding population-based screening program for h. pylori infection to prevent gastric cancer, such as how to perform the optimal screening strategies. a prospective, randomized trial will be conducted to compare the acceptability, compliance (/adherence), and accuracy of diagnostic tests in a population-based h. pylori screening and gastric cancer prevention program. the investigators will recruit 10,000 adults with age of ≥20 years who have not received h. pylori screening or treatment. eligible patients will be randomly 1:1:1:1 allocated to four groups with different combination tests.

background: there are still some unsolved questions regarding population-based screening program for h. pylori infection to prevent gastric cancer, such as how to perform the optimal screening strategies. objective: a prospective, randomized trial will be conducted to compare the acceptability, compliance (/adherence), and accuracy of c13 ubt and hpsa in a population-based h. pylori screening and gastric cancer prevention program. methods：open labeled, randomized controlled trial the investigators will recruit 10,000 adults with age of ≥20 years who have not received h. pylori screening or treatment. eligible patients will be randomly 1:1:1:1 allocated to (a) the carbon-13 urea breath test (c13 ubt), (b) h. pylori stool antigen test (vstrip® hpsa), (c) both c13 ubt and hpsa, (d) two-stage screening method (serology screening only, and then c13 ubt for confirmation if serology test is positive). outcome analysis: 1. detection rate of h. pylori infection 2. to compare the compliance(/adherence) of screening tests for h. pylori infection in the two randomized groups. 3. to assess the diagnostic accuracy of these tests. 4. to verify the compliance(/adherence) and feasibility of this two-stage screening method 5. long-term outcomes: to assess the risk reduction of gastric cancer

Eligibility criteria:
inclusion criteria: * 10,000 adults of ≥20 years * never screened and treated for h. pylori infection exclusion criteria: * ever undergone gastrectomy * patients with gastric cancer * have been screened or tested for h. pylori infection * ever received h. pylori eradication therapy * have taken proton pump inhibitor within two weeks * have taken antibiotics within two weeks

Keywords: h. pylori screening
predictors of perioperative cardiac morbidity

Conditions: Cardiovascular Diseases; Heart Diseases; Myocardial Ischemia; Myocardial Infarction; Ventricular Arrhythmia; Coronary Disease

Summary: to determine the predictors of perioperative cardiac morbidity and mortality in patients at high risk who underwent major noncardiac surgery with general anesthesia.

background: of the 25 million patients who undergo noncardiac surgery in the united states each year, approximately three million have or are at risk of having coronary artery disease. despite advances in the diagnosis and therapy of coronary artery disease, approximately 50,000 of these patients have a perioperative myocardial infarction, and more than half of the 40,000 deaths after surgery are caused by cardiac events. for perioperative myocardial infarction alone, health care costs exceeded $500 million per year in the 1980s. determining the risk factors for adverse postoperative cardiac outcomes allowed the development of preventive strategies and the efficient allocation of health care resources. design narrative: historical, clinical, laboratory, and physiologic data on the subjects were collected during hospitalization for major elective noncardiac surgery with general anesthesia and for six to 24 months after surgery. myocardial ischemia was assessed by continuous electrocardiographic monitoring, beginning two days before surgery and continuing for two days after. the study published many findings under the title study of perioperative ischemia. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria