Kornimate/medical-research-clean huggingface dataset:
couples intervention to improve mental health

Conditions: Suicide

Summary: over the last decade, suicide rates have risen within the military and have remained high. converging evidence suggests that suicide prevention efforts may be enhanced by explicitly including family members in treatment. the study's objectives are to test the effect of the ccrp, a targeted single session couples intervention on suicide ideation among military service members and veterans, and to understand how the use of the ccrp impacts suicide risk during the 6 months immediately postdischarge from a psychiatric inpatient unit.

over the last decade, suicide rates have risen within the military and have remained high. converging evidence suggests that suicide prevention efforts may be enhanced by explicitly including family members in treatment, however no couple-bases suicide-specific interventions exist. the study's objectives are to test the effect of the couples crisis response plan (ccrp), a targeted single-session couples intervention, on suicide ideation among military service members and veterans, and to understand how the use of the ccrp impacts suicide risk during the period of time immediately post-discharge from a psychiatric inpatient unit. the ccrp will be compared to an active control condition (mental health education). the primary aim is to compare the effect of the ccrp to an active control condition on suicide ideation in the 6 months following treatment among military service members and veterans who have been psychiatrically hospitalized for acute suicide risk and their partners. the ccrp is specifically adapted for use with partnered service members at elevated risk for suicide. a secondary aim is to determine how use of the ccrp skills impacts suicidal ideation over time and identify the role partners play in encouraging use of the plan and managing suicide risk.

Eligibility criteria:
inclusion criteria: 1. military service member (active duty or veteran) of any branch or component that has served since 9/11/2001 or the partner of such a service member; 2. that the service member reports active suicide ideation and/or a suicide attempt within the previous 30 days; 3. that the service member is in a committed, exclusive, cohabiting relationship of at least 6 months; 4. the willingness of the service member's partner to participate in research. exclusion criteria: 1. a psychiatric condition, medical condition, or cognitive disability/deficit that precludes the ability of either partner to provide informed consent 2. physical aggression within the past year reported by either partner on a behaviorally-anchored screener for moderate to severe partner violence or extreme relationship distress (a score of of less than 9 on the couples satisfaction index-4) 3. inability of either partner to read or speak english
palliative radiotherapy for symptomatic locally advanced gastric cancer: a phase ii trial

Conditions: Gastric Cancer

Summary: the hypothesis of this study is that a radiotherapy dose of 36gy in 12 fractions, which equates to a bed of 48.6gy, increases the response rates of symptom relief compared to historical controls.

the hypothesis of this study is that a radiotherapy dose of 36gy in 12 fractions, which equates to a bed of 48.6gy, increases the response rates of symptom relief compared to historical controls. (tey et al.) with this dose fractionation is used for bleeding, there is an increase in response rates from 55%(historical) to 75%for pain, there is an increase in response rates from 25% (historical) to 45% for obstruction, there is an increase in response rates from 25% (historical) to 45%

Eligibility criteria:
inclusion criteria: * biopsy proven adenocarcinoma of the stomach * treated with palliative intent * at least one index symptom such as bleeding, obstruction or pain * no prior abdominal radiotherapy * not on chemotherapy exclusion criteria: * patients treated with radical intent * previous abdominal radiotherapy * patients on chemotherapy

Keywords: gastric cancer radiotherapy palliation bleeding pain obstruction
effect of high altitude exposure, acclimatization and re-exposure on psychomotor performance in lowlanders

Conditions: Effect of High Altitude

Summary: prospective interventional trial in lowlanders evaluating the effect of acute exposure, acclimatization and re-exposure to high altitude on psychomotor vigilance to measure sustained attention.

baseline measurements will be performed in santiago de chile, 520 m, over the course of 3 days. participants will then travel by commercial airline (2 h flight) and by bus (2 h ride) to the alma base camp located at 2900 m near san pedro de atacama, northern chile. participants will stay there for the next 7 nights and they will spend the days (6 total; 6-8 h daily) at the telescope station at 5050 m while undergoing testing as described above at the first and the last day at 5050m. daily transports from 2900 to 5050 m will be by car (1 h ride, one way). after the first 7 day altitude sojourn participants will return to the santiago area (520 m) for a 7 day recovery period. a second altitude sojourn with an identical schedule as the one described above and a final low altitude stay of 3 days will follow.

Eligibility criteria:
inclusion criteria: * born, raised and currently living \<1300m * no overnight stays at altitudes \>1500m 4 weeks before the study exclusion criteria: * previous altitude intolerance \<3000m * pregnancy * health impairment, which requires regular treatment

Keywords: high altitude cognition sleep
effect of exercise mode in breast cancer-related lymphedema

Conditions: Breast Cancer Lymphedema; Quality of Life

Summary: gaining a greater understanding of how each exercise mode affects lymphedema, as well as other health-related outcomes will improve exercise prescription guidelines relevant to this specific lymphedema. therefore, the purpose of this work was to compare the effects of xbox kinect rehabilitation and resistance exercises on limb volume, symptoms severity, physical function, and quality of life in women with breast cancer-related lymphedema.

breast cancer-related lymphedema is a common and debilitating side effect of cancer treatment. this study compared the effect of xbox kinect rehabilitation and resistance exercises on breast cancer-related lymphedema volume and severity, as well as participant's physical function and quality of life. women diagnosed with unilateral breast cancer related lymphedema were randomly divided into two groups: the kinect based rehabilitation group kbrg and resistance exercise group reg. woman in the kbrg received virtual reality therapy using xbox kinect-based games, the reg received resistance training in addition both groups received complex decongestive physiotherapy. the intervention was five sessions per week for 8 weeks. the outcome measures included limb volume, symptoms severity, physical function (muscle strength and range of motion) and quality of life. all these outcomes were assessed at pretreatment (baseline) and after the end of treatment at week eight (w8).

Eligibility criteria:
inclusion criteria: * age more than 30. * histological diagnosis of breast cancer at least 1 year prior to the study. * clinical diagnosis of unilateral breast cancer-related lymphedema and obtained medical clearance from their medical oncologists or surgeons. * clinical diagnosis of lymphedema was defined as having at least a 5 % inter-limb discrepancy in volume or circumference. exclusion criteria: * unstable lymphedema, receiving intensive therapy within the previous 3 months. * a musculoskeletal, cardiovascular and/or neurological disorder that could inhibit them from exercising.
the value of 99mtc-leukoscan® scintigraphy in the diagnosis of infectious endocarditis on surgical materials

Conditions: Endocarditis

Summary: infectious endocarditis is a serious pathology with difficult diagnosis especially on prosthetic valves or cardiac device because of the plurality of clinical presentations and the low sensitivity value of echocardiography in these patients. despite a well validated indication for the detection of septic emboli, the value of fdg-pet for the detection of prosthetic valves or cardiac implantable device is still unclear especially because of frequent non-septic inflammatory processes. to improve the specificity value, the use of radio-labeled leukocytes scintigraphy is conventionally proposed. an alternative method is to label leukocytes in vivo with an anti-murin anti body fragment ( sulesomab , leukoscan®). this scintigraphy is regularly used in the investigation of osteomyelitis and has been proposed in infectious endocarditis. to knowledge of investigators, the value of leukoscan® scintigraphy on prosthetic valve or cardiac device infection had not been studied.


Eligibility criteria:
inclusion criteria: * male or female subjects aged \> 21 years * patients presenting a suspicions of infectious endocarditis on surgical materials * written informed consent exclusion criteria: * patient with a history of exposure to murine antigens, particularly a patient who has already received a 99mtc-leukoscan® scintigraphy * patients whose clinical condition requires prompt care, not allowing them to wait for the examination * pregnant or nursing (including pumping for storage and feeding) * patients under adapted antibiotic therapy for more than 15 days * deprivation of civil rights (curatorship, guardianship, safeguard of justice)

Keywords: infectious endocarditis prosthetic valve infection implantable cardiac device infection 99mtc-leukoscan® scintigraphy
dose finding study of rad001 (everolimus, afinitor®) in combination with bez235 in patients with advanced solid tumors

Conditions: Advanced Solid Tumors; Metastatic Breast Cancer; Metastatic Renal Cell Carcinoma

Summary: study has two parts: 1. dose-finding: to determine the maximum tolerated dose (mtd) and to evaluate the safety and tolerability of rad001 (everolimus , afinitor®) in combination with bez235 in patients with advanced solid tumors. 2. dose-expansion: to assess safety and tolerability of rad001 and bez235 at the mtd in patients with er+/her2- metastatic breast cancer and metastatic renal cell cancer


Eligibility criteria:
inclusion criteria: * male and female patients age 18 years or older * in the dose finding phase, patients with histologically or cytologically confirmed advanced solid malignancies that are metastatic or unresectable * in the dose expansion phase, the enrollment will be limited to patients with: patients with metastatic renal cell carcinoma (mrcc) whose disease had progressed despite prior treatment with vegfr-tki (vascular endothelial growth factor receptor tyrosine kinase inhibitor) therapy (at least one but no more than two lines of vegfr-tki therapy) patients with metastatic breast cancer (mbc) which is er+/her2-, whose disease had progressed despite prior treatment with at least one but no more than two lines of chemotherapy and at least one prior line of endocrine therapy in the metastatic setting * who performance status of 0-2 * lab parameters within specifically defined criteria * patients with measurable disease per recist 1.0 exclusion criteria: * patients who have previously received mtor inhibitors or pi3k inhibitors * patients with cns metastases unless previously treated with surgery, whole-brain radiation or stereotactic radiosurgery plus the disease having been stable for at least 2 months without steroid use for at least 1 month prior to the first dose of rad001 and bez235. subjects are not permitted to receive enzyme-inducing anti-epileptic drugs. * major surgery within 2 weeks prior to study enrollment * patient taking anti-cancer drug concomitantly * received radiation within 4 weeks prior to study enrollment (2 weeks if limited field radiation) * receive chemotherapy 4 weeks prior to study enrollment * received live attenuated vaccines within 1 week prior to study enrollment * history of hiv * any other severe and/or uncontrolled medical condition other protocol-defined inclusion/exclusion criteria may apply

Keywords: advanced solid tumors metastatic renal cell carcinoma (mrcc) er+/her2-metastatic breast cancer (mbc) dose finding study mtor pl3k bez235 rad001 everolimus afinitor® er+/her2- metastatic breast cancer
efficacy and safety study of spl7013 gel to prevent the recurrence of bacterial vaginosis (bv)

Conditions: Bacterial Vaginosis

Summary: a double-blind, phase 3 study to determine the efficacy of spl7013 gel when administered on alternate days for 16 weeks, compared to placebo gel in preventing the recurrence of bv in women with a history of recurrent bv.

eligible participants, with both a history of recurrent bv and a current episode of bv, will receive a seven-day course of oral metronidazole. participants who are successfully treated for their bv, and continue to be eligible, will be randomly assigned to receive either 1% spl7013 gel or placebo gel on alternate days at bed-time for 16 consecutive weeks. the primary endpoint will be determined at the conclusion of this 16 week treatment phase. participants who experience a bv recurrence will be considered to have completed the study. such participants will receive bv treatment in line with local practice and will not attend any further study visits. participants who successfully reach week 16 without a bv recurrence will enter a 12-week follow-up phase to week 28. participants will attend a study visit at 4-weekly intervals throughout the duration of the study to week 28 (or up to the point of bv recurrence) to assess recurrence of bv and adverse events.

Eligibility criteria:
inclusion criteria: * current active episode of bv (diagnosis defined as: at least 3 amsel criteria; nugent score of at least 4; presence of bv-related symptoms) * history of recurrent bv (at least 3 episodes in previous year including current episode) * using an effective method of contraception exclusion criteria: * test positive for a sexually transmitted infection * presence of genital herpes simplex virus (hsv) lesions or human papilloma virus (hpv) lesions requiring treatment * abnormal pelvic exam, including presence of other vaginal or urinary tract infections * pregnancy
salvage surgery for patients with metastatic gist with rego

Conditions: Gastrointestinal Stromal Tumors; Metastasis; Disease Progression

Summary: some researches have shown surgery may acquire progression-free (pfs) benefit for selected patients with metastatic gastrointestinal stromal tumor (gist) who received first-line imatinib and second-line sunitinib. however, impact of salvage surgery on pre-treated gist patients receiving third-line regorafenib facing progression is not yet reported. investigators retrospectively reviewed patients with regorafenib treatment with salvage surgery.

between 2014 and 2019, 41 metastatic gist patients received regorafenib therapy. 35 out of 41 metastatic gist patients who were on regorafenib therapy facing progression and 15 experienced local progression underwent salvage surgery. thirty-five of 41 (85.4 %) pre-treated gist patients receiving regorafenib who experienced disease progression after a median follow-up of 12.4 months of regorafenib use. 15 out of 35 (42.9%) metastatic gist patients receiving regorafenib facing progression underwent salvage surgery.

Eligibility criteria:
inclusion criteria: 1. patients who is taking regorafenib after treatment failure by 1st line and 2nd line tyrosine kinase, namely imatinib and sunitinib. 2. patients with aforementioned condition and is facing local progression of disease or stationary disease. exclusion criteria 1. systemic progression of disease 2. asa classification \> 3

Keywords: regorafenib gastrointestinal stromal tumors metastasis local progression surgery
study to evaluate the safety and efficacy of hlbls-200 in patients requiring hemostatic technique

Conditions: Hemorrhage

Summary: this is a prospective, open-label, exploratory clinical trial designed to investigate the safety and efficacy of hlbls-200 (an investigational hemostatic agent). the study will recruit approximately 8 subjects.

patients scheduled for hepatic resection who voluntarily agree to participate the study will be recruited for the screening procedures. patients who meet the eligibility criteria will be assigned to the study. subjects will receive hlbls-200 as a supplementary hemostatic technique for oozing hemorrhage which can be occurred during hepatic resection. a dose of hlbls-200 based on the area of liver resection will be applied and time to hemostasis of blood oozing will be evaluated. patients will be followed for 12 weeks after application of hlbls-200 to monitor any adverse event. study objective: 1. to investigate the safety of hlbls-200 application. 2. to explore hemostatic function of hlbls-200 in patients receiving hepatectomy.

Eligibility criteria:
inclusion criteria: (during screening period) * subject aged between 18 and 80 years old and scheduled for non-emergent hepatic resection. * subject is willing to provide written consent and able to comply with study procedures. * female subject of childbearing potential who is willing to use an adequate method of contraception or to be abstinent during the course of the study. inclusion criteria: (during hepatectomy) * subjects who need to receive additional hemostatic treatment for blood oozing at the resection site after application of primary hemostatic methods. exclusion criteria: (during screening period) * subject with a history of bleeding disorder, platelet disorder or bone marrow disorder. * platelet count \ 2. * subject who received any drug affecting hemorrhage and/or hemostasis such as anticoagulants, antiplatelet agents or thrombolytic agent within 2 weeks prior to hepatectomy. * subject with a history of hypersensitivity to the substance of the investigational device. * creatinine clearance \< 30ml/min * aspartate transaminase or alanine aminotransferase ≥ 3.0 x upper limit of normal. * subject with a suspected disorder of decrease in fibrinolytic activity such as disseminated intravascular coagulation. * subject with a history of alcohol or drug abuse. * pregnant or lactating women * subject who have participated in other clinical trial and have received investigation drugs or devices within 4 weeks prior to participation in the study. * subject who were judged by the investigator as inadequate for participation in the study. exclusion criteria: (during hepatectomy) * subject with following major bleeding (e.g. spurting hemorrhage, hemorrhage from hepatic veins) despite application of primary hemostatic methods * subject who is deemed to need anticoagulant treatment within 48 hours of hepatectomy. * for other reason, subject who were judged by the investigator as inadequate for participation in the study.

Keywords: hemostatic blood oozing absorbent hemostatic liver resection intraperitoneal surgery
effect of high rebound mattress toppers on sleep and sleep-related symptoms

Conditions: Sleep Disorders

Summary: the purpose of the study is to evaluate effects of high rebound mattress toppers (i.e., airweave®) on sleep and sleep-related symptoms. the study will compare effects of use of high rebound mattress toppers versus use of low rebound mattress toppers on sleep and sleep related symptoms and core body temperature during diagnostic sleep studies.


Eligibility criteria:
inclusion criteria: * adults age 18-65 who are scheduled for a diagnostic sleep study at the stanford sleep clinic for sleep disorders (including but not limited to, insomnia, sleep apnea or other sleep disorder symptoms). exclusion criteria: * individuals with a history of having difficulty swallowing food or large capsules. we will not be able to enroll individuals with any known or suspected obstructive disease of the gastrointestinal tract including, but not limited to esophageal stricture, diverticulosis and inflammatory bowel disease (ibd), peptic ulcer disease, crohn's disease, ulcerative colitis, previous gastrointestinal surgery. * individuals who are pregnant. * individuals who are unable to provide informed consent (i.e. decisionally impaired).

Keywords: sleep apnea insomnia sleep disorders sleep environment core body temperature
efficacy study of avastin® with pemetrexed +/- carboplatin to treat elderly patients with non-small cell lung cancer

Conditions: Non-squamous Non-small Cell Lung Cancer

Summary: multi-center, open, randomized (parallel) and comparative phase iii. eligible patients will receive bevacizumab + chemotherapy for a minimum of 4 cycles followed by bevacizumab (+ pemetrexed, if appropriate) maintenance therapy until disease progression. arm a: bevacizumab + pemetrexed arm b: bevacizumab + pemetrexed + carboplatin

primary: * proof of non-inferior efficacy of a monochemotherapy regimen of pemetrexed plus bevacizumab versus a combination chemotherapy regimen of pemetrexed-carboplatin plus bevacizumab in elderly patients(\> 65 years) as first-line treatment of advanced metastatic or recurrent non-squamous nsclc by progression free survival secondary: * to assess the efficacy of bevacizumab as measured by overall response rate and overall survival. * to assess the safety of bevacizumab in combination with pemetrexed and pemetrexed and carboplatin. * to assess quality of life by eortc questionnaire qlq-c30 and its lung cancer module lc-13 * to assess activity of daily life (iadl) in relation to ecog performance status prior to study treatment * to assess patient's outcome and treatment delivery in relation to the charlson comorbidity score and the simplified comorbidity score

Eligibility criteria:
inclusion criteria: * stage iiib and iv nsclc, excluded squamous cell nsclc * age ≥ 65 years * ecog 0-2 exclusion criteria: * mixed, non-small cell and small cell tumours or mixed adenosquamous carcinomas with a predominant squamous component * history of haemoptysis * evidence of tumour invading major blood vessels on imaging * radiotherapy within 28 days prior to enrolment * patients who are unable to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose ≤ 1.3 grams per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam) * current or recent (within 10 days of first dose of bevacizumab) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic purposes. prophylactic use of anticoagulants is allowed * clinically significant (i.e. active) cardiovascular disease for example cva (≤6 months before enrolment), myocardial infarction (≤6 months before enrolment), unstable angina, chf nyha class ≥ii, serious cardiac arrhythmia requiring medication during the study and might interfere with regularity of the study treatment, or not controlled by medication * non-healing wound, active peptic ulcer or bone fracture * history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrolment

Keywords: lung cancer nsclc elderly non-squamous elderly patients at least 65 years old first line therapy non-squamous non-small cell lung cancer stage iiib or iv