Kornimate/medical-research-clean huggingface dataset:
fes-pet to determine er-expression in epithelial ovarian cancer

Conditions: Epithelial Ovarian Cancer

Summary: estrogens are implicated in the development of ovarian cancer and estrogen receptors (er) alpha and beta are present in 20-100% of ovarian cancer patients. for this reason, antihormonal therapy with anti-estrogens or er-antagonists is potentially an attractive treatment option. however, only a small proportion of patients (5-19%) will respond to antihormonal therapy. er-expression in er-positive breast cancer can be assessed by positron emission tomography (pet) with \[18f\]fluoroestradiol (fes). in this study the investigators will evaluate whether fes-pet can be used to visualize and quantify er-expression in ovarian cancer. if these results are positive, this would warrant further exploration of fes-pet imaging in ovarian cancer.

investigators will evaluate whether fes-pet can be used to visualize and quantify er-expression in ovarian cancer. if these results are positive, this would warrant further exploration of fes-pet imaging in ovarian cancer.

Eligibility criteria:
inclusion criteria: 1. histological evidence or high clinical suspicion of epithelial ovarian cancer 2. the presence of at least one measurable lesion (recist version 1.1). 3. histology or cytology can be obtained (may be ascites) 4. eastern cooperative oncology group performance status 0-2. 5. postmenopausal status (defined as either \>45 years with amenorrhea \>12 months, or prior bilateral ovariectomy) 6. no history of other er-positive malignancies 7. signed written informed consent 8. able to comply with the protocol exclusion criteria: 1. use of estrogen receptor ligands, including tamoxifen, fulvestrant or estrogens, during the 5 weeks before entry into the study 2. life-expectancy ≤ 3 months
tumor immunity and cancer recurrence prediction model

Conditions: Cancer

Summary: the purpose of this observational study is to understand the predictive effect of the laboratory-developed times scoring system on the recurrence status of cancer patients who have undergone surgical tumor resection. the main questions it aims to answer are: can the times scoring system accurately predict the recurrence status of cancer patients who have undergone surgical tumor resection? what is the accuracy of the times scoring system? the medical records or biological specimens used in this study were obtained from previous clinical treatments, and the tissues used were collected from post-surgical discarded tissues from the participants, which will not affect their health. researchers will continuously monitor the disease progression of the participants for up to 10 years or until cancer recurrence occurs.

no grouping, the long-term tracking of participants' disease progression and recurrence status will be compared with the analysis results of the collected discarded tumor tissues from the participants' surgeries

Eligibility criteria:
inclusion criteria： 1.adult males and females (non-pregnant, non-lactating)； 2.18 years or older (inclusive); 3.diagnosis: diagnosed with cancer (e.g., liver cancer, lung cancer, gastric cancer, colorectal cancer, etc.) and eligible for surgical resection; 4.informed consent: participants must be fully informed about the study prior to participation and voluntarily sign a written informed consent form; exclusion criteria： 1. specimens from pregnant or lactating patients will not be included in this study, and participant should have no plans for pregnancy or lactation within the next 2 years. 2. participants must be at least 18 years old.

Keywords: cancer immunity tumor
a study evaluating an advanced pneumatic compression device versus usual care for treatment of head and neck lymphedema

Conditions: Lymphedema; Lymphedema of Face; Lymphedema, Secondary; Lymphedema Due to Radiation; Lymphedema; Surgical

Summary: to compare the effectiveness of an apcd to usual care in the management of lymphedema and fibrosis (lef) in head and neck cancer (hnc) survivors.

aim 1: to compare the short-term and long-term effectiveness of self-administered apcd therapy versus usual care in hnc survivors with treatment naive lef on anatomical measures of internal and external lef. baseline measures will be obtained at the start of therapy. short-term effectiveness will be evaluated at 2 months and long-term effectiveness will be evaluated at 4 and 6 months. hypothesis: the apcd therapy will be associated with greater short-term and long-term reduction in anatomical measures of lef. aim 2: to compare the short-term and long-term effectiveness of self-administered apcd therapy versus usual care in hnc survivors with treatment naive lef on patient reported biopsychosocial outcome measures impacted by lef. outcome measures will include: 1) symptom burden, 2) symptom burden and functional impairment, 3) quality of life (qol), 4) work and activity, 5) perceived self-management capacity, 6) body image, and 7) diet modifications. baseline measures will be obtained at the start of therapy. short-term effectiveness will be evaluated at 2 months and long-term effectiveness will be evaluated at 4 and 6 months. hypothesis: the apcd therapy will be associated with greater short-term and long-term improvement in patient reported biopsychosocial outcomes.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. pathologically confirmed cancer of the hnc (larynx, pharynx, oral cavity, paranasal sinuses, major salivary glands, and hnc of unknown primary) 3. completed curative intent cancer therapy with no evidence of active cancer at time of study enrollment 4. a diagnosis of either internal or external head and neck lymphedema 5. at least one core lymphedema associated symptom of ≥ 4 out of 10 at the time of study screening 6. must be able and willing to participate in all aspects of the study and provide informed consent prior to study participation 7. must be able to speak and understand english exclusion criteria: 1. previous apcd or usual care treatment for hnc lef 2. acute facial infection (e.g., facial or parotid gland abscess) 3. known carotid sinus hypersensitivity syndrome 4. symptomatic carotid artery disease, as manifested by a recent transient ischemic attack (within 30 days), ischemic stroke, or amaurosis fugax (monocular visual ischemic symptoms or blindness) 5. internal jugular venous thrombosis (within 3 months) 6. patient is pregnant or trying to become pregnant

Keywords: head and neck lymphedema
improving outcomes for patients requiring oral bowel preparation for colonoscopy

Conditions: Colorectal Cancer

Summary: study hypothesis the overall aim of this study is to compare two bowel preparations that are used prior to a colonoscopy procedure. the principal research questions are: 1. does the use of a low residue diet increase patient concordance to the bowel preparation instructions? 2. does the use of a low residue diet decrease the adequacy of assessment of the mucosa? 3. does the use of a low residue diet increase the willingness of patients to undertake repeated examination as is required for disease follow-up? 4. does body weight affect perceived tolerability of either group?


Eligibility criteria:
inclusion criteria: * patients attending for colonoscopy. * patients referred for colonoscopy via general practitioner. exclusion criteria: * individuals who would not fully understand trial purpose (assessed by a cognisance scale if required) * previous episodes of total or partial small bowel obstruction * previous colonic surgery * known swallowing disorder * pregnancy * extremes of age (less than 16 or greater than 80) * small intestine disorders * renal insufficiency (serum creatinine\> 110) * congestive heart failure * presence of ascites * severe colitis

Keywords: colonoscopy colorectal screening colon preparation
treatment of post traumatic stress disorder in patients with other mental illnesses

Conditions: Stress Disorders, Post-Traumatic

Summary: the purpose of this study is to develop an effective treatment for people with post traumatic stress disorder (ptsd) along with other mental illnesses.

despite the progress in treating ptsd in the general population and the elevated prevalence of ptsd in people with severe mental illness (smi), there are no empirically validated treatments designed for patients with comorbid ptsd. the cognitive behavioral treatment provided in this study may improve knowledge of ptsd, decrease distorted beliefs, reduce ptsd symptoms, and improve quality of life. participants are randomly assigned to receive either a cognitive behavioral treatment plus standard care for smi or standard care alone. the cognitive behavioral treatment incorporates several common features, including psychoeducation, relaxation training, and cognitive restructuring. standard care for smi includes medication, case management, and psychosocial treatment. ptsd, psychiatric symptoms, health, quality of life, and substance abuse outcomes are measured. participants' knowledge of ptsd and beliefs about the world are also measured. participants are assessed at baseline, post-treatment (16 weeks), and at 3- and 6-month follow-ups. for information on a related study, please follow this link: http://clinicaltrials.gov/show/nct00494650

Eligibility criteria:
inclusion criteria: * post traumatic stress disorder * new hampshire definition of smi plus dsm-iv axis i diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depression * case management services and contact with a case manager at least twice a week exclusion criteria: * alcohol or drug dependence * hospitalization or suicide attempt in the past 2 months

Keywords: comorbidity schizophrenia bipolar disorder depression
clinical course of alcohol use disorder recovery

Conditions: Alcohol Use Disorder

Summary: the goal of this single-arm clinical trial is to better understand the ways in which individuals seeking treatment recover from alcohol use disorder (aud). the main aims are to: * to establish operational definitions of types of change in relation to national institute on alcohol abuse and alcoholism's (niaaa) new definition of recovery, and to distinguish between treatment response, remission versus recovery, and relapse versus recurrence. * to describe patterns of recovery, including the frequency of within-person transitions between types of change in clinical course to better understand the dynamic nature of recovery. * to examine the predictive relationships between theoretically important cognitive, behavioral, and affective process variables and changes during recovery, with a focus on how people initiate versus maintain change. participants will: * receive 12 weeks of psychotherapy for alcohol use disorder * complete brief assessments after each treatment session. * complete brief assessments bi-weekly via phone for 1-year following treatment. * complete in-person interviews at 3 or 6-month intervals post-treatment.

the aim of the current application is to examine the utility and validity of national institute on alcohol abuse and alcoholism's (niaaa)new definition of recovery within the context of a novel theoretical model. the proposed study will recruit participants seeking treatment for alcohol use disorder (aud) from the community. participants will complete a structured clinical interview and provide information on their current alcohol use and related behaviors. all participants will receive 12 weeks of aud psychotherapy and complete brief assessments at the end of each treatment session and biweekly during the first 12-months post treatment. in addition, participants will complete in-person interviews at 3-month and 6-month intervals post-treatment for the duration of the study (for up to 24-54 months post treatment depending on time of enrollment). findings from the proposed research have the potential to increase understanding of the dynamic nature of recovery and thereby improve clinical decision-making and generate future research. specifically, our goal is to address the question of "are the constructs of relapse, recurrence remission, or recovery useful heuristics for clinical practice and research, and if so, how?"

Eligibility criteria:
inclusion criteria: 1. current diagnosis of aud (initial screening audit ≥ 8, confirmed with diagnostic interview), 2. live within commuting distance of the program site, 3. provide informed consent. exclusion criteria: 1. acute psychosis or severe cognitive impairment (assessed via psychotic module of the m.i.n.i and mini-mental state ≤ 23), 2. current drug use diagnosis other than nicotine or marijuana use disorders, 3. lack of sufficient familiarity with the english language to comprehend the recruitment and consent procedures, 4. legally mandated to attend treatment
rgi-2001 for the prevention of acute graft-vs-host disease in subjects following allogeneic hematopoietic stem cell transplantation

Conditions: Graft Vs Host Disease; Graft-versus-host-disease; Acute-graft-versus-host Disease; Prevention of aGVHD

Summary: this phase ii open label study will evaluate the safety and efficacy of repeat doses of rgi-2001 in combination with standard of care treatment for the prevention of acute graft-vs-host-disease (agvhd) in subjects following allogeneic hematopoietic stem cell transplantation (allohsct). these subjects will be compared to contemporary controls.

this is an open-label, multi-center, single-arm study to evaluate six weekly doses of rgi-2001 in combination with standard of care treatment for the prevention of agvhd in subjects following allohsct. the study will include a safety run-in phase to assess the safety and tolerability of 6 weekly doses of rgi-2001 followed by an expansion phase in which the potential efficacy of 6 weekly doses of rgi-2001 in addition to standard of care for gvhd prophylaxis will be assessed. comparison will be made to a contemporaneous control group.

Eligibility criteria:
inclusion criteria: 1. ages ≥ 18 and ≤ 65 years of age 2. has a hematologic malignancy which includes acute myelogenous leukemia (aml), t or b cell acute lymphoblastic leukemia (all) myelodysplastic syndrome (mds), chronic myelomonocytic leukemia (cmml), myeloproliferative disorder (mpd) including myeloid metaplasia and cml 3. must have adequate organ function 4. transplant donor: matched related donor or unrelated donor 5. is a candidate for anti-graft-vs-host-disease (gvhd) prophylaxis that includes a calcineurin inhibitor 6. ability to understand and willingness to sign a written informed consent form 7. if female of childbearing potential, must have had a negative serum pregnancy test prior to enrollment and must have agreed to use a double barrier method of contraception for 30 days after rgi-2001 administration 8. if male, must be sterile or willing to use an approved method of contraception from the time of informed consent to 90 days after last dose of rgi-2001 administration exclusion criteria: 1. has had any other prior organ transplantation 2. planned procedure to deplete regulatory t cells from donor transplant materials 3. planned reduced intensity conditioning 4. has had prior treatment with anti-cd3, other t cell depleting antibodies, or anti-thymocyte globulin within 12 months prior to allohsct procedure 5. has progressive underlying malignant disease including post-transplant lymphoproliferative disease 6. has evidence of active central nervous system (cns) disease including known brain or leptomeningeal disease (ct or mri scan of the brain required only in case of clinical suspicion of cns involvement) 7. is female and pregnant or lactating 8. has a documented history of uncontrolled autoimmune disease or on active treatment 9. history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to receiving study drug
using cbt to probe psychobiobehavioral resilience to post-trauma psychopathology

Conditions: Anxiety; Depression

Summary: this randomized controlled trial uses a modularized cognitive behavioral resilience training (mcbrt) intervention to probe risk and resilience mechanisms linked to post-trauma psychopathology. ninety participants with a history of interpersonal trauma during childhood or adolescence and mild to moderate distress will be randomized to mcbrt or a health education control condition. the primary aims of this proposal are to examine whether individuals who receive mcbrt demonstrate increases in psychological resilience, biological resilience, and extinction learning compared to those in the control group. this study will also explore associations between these psychobiobehavioral risk and resilience factors.


Eligibility criteria:
inclusion criteria: 1. 18 years of age or older 2. fluent in english 3. history of childhood interpersonal trauma (e.g., sexual assault, physical assault, witnessing assault before age 18) 4. mild to moderate distress indicated by a score of 10-20 on the depression scale, 8-14 on the anxiety scale, or 15-25 on the stress scale of the dass-21. exclusion criteria: 1. severe distress indicated by a score \>20 on the depression scale, \>14 on the anxiety scale, or \>25 on the stress scale of the dass-21 2. dsm-5 criterion a trauma in the past month 3. color blindness based on self-report (because of inability to complete the fear conditioning task) 4. auditory impairment based on audiometer screening (because of inability to complete the fear conditioning task) 5. lifetime psychotic or bipolar disorder 6. substance abuse or dependence within past 6 months 7. concurrent psychotherapy initiated within 3 months of randomization 8. ongoing psychotherapy of any duration directed toward treatment of trauma-related psychopathology (e.g., cbt) 9. must be on a stable dose of psychotropic or adrenergically-active medications (e.g., beta blockers) for at least 6 weeks prior to eligibility screening 10. mental retardation or significant cognitive impairment 11. serious medical illness or instability for which hospitalization may be likely within the next year 12. significant suicidal ideation indicated by "yes" on columbia suicide severity rating scale item 4 (active suicidal ideation with some intent to act) or enacted suicidal behaviors within 6 months prior to eligibility 13. current legal actions related to trauma.

Keywords: childhood trauma
the combination of palbociclib with ddec-p as neoadjuvant therapy in triple negative breast cancer

Conditions: Breast Cancer; Breast Diseases; Breast Neoplasms

Summary: this study will look at effects the combination of palbociclib and dose-dense neoadjuvant chemotherapy may have on triple negative breast cancer tumours which have not yet been treated.

patients will be randomized to one of two treatment arms (1:1 ratio). dose-dense neoadjuvant chemotherapy in the first 8 weeks of will be: epirubicin (90mg/m2) and cyclophosphamide (600mg/m2), followed by paclitaxel (80mg / m2) after 8 weeks, cycled every 14 days for total 8 cycles. palbociclib will be administered orally as 125mg capsules, daily on a schedule of 3 weeks (21 days) on, 1 week (7 days) off of a 4 week \[28 days\] cycle. arm i: palbociclib combined with dose-dense neoadjuvant chemotherapy for total 16 weeks. arm ii: placebo combined with dose-dense neoadjuvant chemotherapy for total 16 weeks. note: following completion of study therapy, surgery will be scheduled for 18-20 weeks post-randomization. post-surgical treatment will be at the discretion of treating clinician, following postoperative pathology. after week 16 (end of study therapy) all patients should continue palbociclib for one year. toxicity will be graded according to the national cancer institute (nci) common terminology criteria for adverse events version 4.0 (ctcae v4.0).

Eligibility criteria:
inclusion criteria: 1. female patients, 18 years ≤ age ≤ 80 years； 2. performance status- eastern cooperative oncology group (ecog) 0-1 3. histologically confirmed invasive breast cancer（early stage or locally advanced） 4. her2 negative (her2+/- by ihc or fish-) 5. hormone receptor (er and pr) negative 6. cardiovascular: baseline left ventricular ejection fraction (lvef)≥55% measured by echo 7. signed informed consent form (icf) exclusion criteria: 1. metastatic disease (stage iv) or inflammatory breast cancer 2. previous or current history of malignant neoplasms, except for curatively treated: basal and squamous cell carcinoma of the skin, carcinoma in situ of the cervix. 3. clinically relevant cardiovascular disease: known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110); 4. unable or unwilling to swallow capsules.
evaluation of the implementation of drug prescription recommendations using clinical decision support in patients with severe obesity: retrospective study

Conditions: Obesity, Morbid; Drug Use

Summary: no drug prescription guidelines for severe obesity (bmi\>35 kg/m2) are available, leading to non-standardized and / or potentially inappropriate drug management. after validation of guidelines by the delphi method, the main objective is to assess the agreement between the drug prescriptions and the guidelines after implementation in two health data warehouses. the investigators will perform a retrospective, multicentric study in 2 hospitals. the investigators will check the relevance of rules (alerts) derived from the recommendations identified using the delphi method.

no drug prescription guidelines for severe obesity (bmi\>35 kg/m2) are available, leading to non-standardized and / or potentially inappropriate drug management. after validation of guidelines by the delphi method, the main objective is to assess the agreement between the drug prescriptions and the guidelines after implementation in two health data warehouses. the investigators will perform a retrospective, multicentric study in 2 hospitals. the investigators will check the relevance of rules (alerts) derived from the recommendations identified using the delphi method. the sponsor anticipate around 800 patients in the hegp data warehouse and around 250 patients in the rennes university hospital data warehouse. the main outcome will be the number of prescriptions concerned by rules, by type of recommendation, in patients with severe obesity. secondary outcomes will be : 1. number of validated recommendations and their level of evidence, 2. rate of prescriptions concerned by a computerized rule with pharmaceutical advice on the drug concerned by the rule. sub-group analysis of this rate by type of recommendation. the study will be conducted in 2 steps: * stage 1 (secondary endpoint): it consists of the final drafting of recommendations and submission to experts/analysis of feedback. this stage is scheduled to last 12 months. * stage 2 (primary and secondary judgment criteria): it consists of implementing the recommendations and studying the relevance of the rules. this stage is scheduled to last 8 months. around a hundred patients corresponding to this criteria will be extracted from the hegp data warehouse

Eligibility criteria:
inclusion criteria: all patients aged 18 to 65 at the time of prescription with a bmi\>35 kg/m² present in the clinical data warehouse of the hegp and chu rennes during the study period with at least one hospitalization of more than 24h. exclusion criteria: * patients who refused to have their records processed electronically. * patients with a history of bariatric surgery (sleeve gastrectomy, gastric band, gastric bypass) prior to hospitalization.

Keywords: prescription drug guidelines clinical decision support system rule-based alert system