Kornimate/medical-research-clean huggingface dataset:
using liquid biopsy in newly diagnosed patients with high grade adenocarcinoma of ovarian origin, fallopian tubes or primary peritoneal

Conditions: Ovarian Cancer

Summary: bovary-ce is a monocentric, pilot, longitudinal, real-life study with a total duration of 36 months. the purpose of this study is to assess the feasibility of using liquid biopsy as a substitute for tissue multisampling, in order to describe clonal heterogeneity and tumor evolution in patients with ovarian cancer. the method involves the inclusion of 20 patients with high-grade ovarian adenocarcinoma, fallopian tubes or primary peritoneal origin, not pretreated, newly diagnosed, and eligible for treatment who will participate in the research. these patients will have several samples throughout their treatment for a period of 2 years: blood samples which will be taken at each therapeutic moment of interest. tissue samples which will be taken at the time of the diagnostic laparoscopy and at the time of surgery. the concentration of cfdna and tumor heterogeneity will be used to predict disease-related events defined as relapse, progression or death.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * patient with non-treated high grade serous and endometrioid carcinoma of ovarian, fallopian tube, or primary peritoneal origin proven cytologically or histologically at inclusion and eligible for treatment * patient eligible for an upfront surgery or pretherapeutic coelioscopy * adequate haemoglobin rate ≥ 9 g/dl * patient affiliated to a social security scheme * ability to provide written informed consent exclusion criteria: * age \< 18 years * any concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study * contraindication to blood samples of 20 ml * pregnant or breast-feeding women * ongoing treatment for the newly diagnosed cancer or the recurrence * other cancers treated within the last 5 years * patient under guardianship or curatorship or deprived of liberty
healing response to everolimus-eluting stent implantation; serial assessment with optical coherence tomography

Conditions: Coronary Heart Disease

Summary: the purpose of this study is to evaluate serial changes of neointimal coverage after everolimus-eluting stent implantation at 3-, 6- and 12-months by oct examination.

late and very late stent thrombosis is current main issue after introduction of drug-eluting stents .possible causes of these stent thromboses include thrombus formation resulting from delayed neointimal coverage, spasms occurring at the distal end of the stent implantation site, positive remodeling of coronary arteries caused by local immune reaction to paclitaxel or rapamycin, and vascular endothelial damage induced by the polymer. for bms, neointimal coverage begins within the first one month after stent implantation and almost completes in three months. for des, sirolimus eluting stents (ses) for example, neointimal coverage is markedly delayed after stent implantation and the exposed stent struts may be largely attributable to the occurrence of late stent thrombosis. on the other hand, everolimus eluting stents (ees), which have a thinner stent strut layer and improved polymer biocompatibility, it has been reported that earlier and more normal neointimal coverage can be achieved compared with other first-generation dess, ses and paclitaxel eluting stents (pes). these findings suggest that coverage with vascular endothelium differs among different des platforms. optical coherence tomography (oct) has a resolution of 15 to 20 μm, which is approximately 10 times higher than that of intravascular ultrasound (ivus). it is therefore necessary to use oct to accurately evaluate cross-sectional images of the stent struts covered with vascular endothelium. however, no studies have reported the results of continuous observation and evaluation of ees covered with endothelium. therefore, the investigators investigate time course of neointimal coverage of ees through detailed evaluation by oct of neointimal coverage at 3, 6, and 12 months after stent implantation.

Eligibility criteria:
inclusion criteria: 1. older than 20 years old. 2. indication of pci. 3. to agree to review and record all the clinical course in this research protocol. 4. the patient who are eligible to receive dual antiplatelet therapy at least more than 6 month. 5. informed concent with the document signed by the patients. the patient have to correspond to all the above items at the time of registration. exclusion criteria: 1. the patient who died during the research 2. the patient with stent thrombosis during the research. 3. previous history of pancytopenia, liver function, renal dysfunction, hypersensitive history of the drug. 4. low ejection fraction (lvef\<=30%), an impaired liver function, and renal dysfunction (egfr\<=30) 5. the patient excluded from a safety of a thiazolidine derivative. lesion exclusion criteria 1. left main artery 2. severe calcification 3. stent restenosis
effectiveness of dry needling vs manual therapy in patients with temporomandibular joint disorders.

Conditions: Temporomandibular Joint Disorders; Dry Needling; Musculoskeletal Manipulations

Summary: temporomandibular joint disorders (tjd) represent a set of conditions that involve pain and dysfunction of the temporomandibular joint. tjd are a frequent disability affection in the worldwide population and the 35% of affected present at least a symptom such as orofacial pain, mouth movement limitations and snapping or crying temporo-mandibular. due to the increase of the incidence of the tjd the investigators propose to complete this study. a randomized controlled trial with parallel groups have been designed and blind evaluation of the response variable. the hypothesis is that dry needling produces a positive effect in the involved variables of this study in comparison with manual therapy. the aim of this rct is to compare the effectiviness of the application of manual therapy in comparison with dry needling in the perceived pain, mouth opening, the degree of cervical disability and the pressure-pain threshold (ppt) of myofascial trigger points (mtrp) in patiens with tjd.


Eligibility criteria:
inclusion criteria: female and male subjects with an age of 18-65 years old with a tjd who meet at least two of the following inclusion criteria: * pain on palpation of the myofascial trigger points of the masseter, anterior temporal, posterior temporal, external pterygoid and sternocleidomastoid muscles (minimum 3 active trigger points). * pain in the temporomandibular joint. * limitation of mouth opening. * clicking of the temporomandibular joint. exclusion criteria: subjects who present any of the following characteristics: * fibromyalgia, orthodontia, systemic disease, syndrome or pathology with possible joint repercussions, patients undergoing treatment with nsaids, jaw fracture, mandibular surgery, non-collaborative patients or patients with phobia needles.

Keywords: temporomandibular joint disorders dry needling manual therapy orofacial disability neck pain
exablate blood-brain barrier disruption for the treatment of rgbm in subjects undergoing carboplatin monotherapy

Conditions: Recurrent Glioblastoma

Summary: the purpose of this study is to evaluate the safety and feasibility of the exablate model 4000 type 2 system when used as a tool to open the blood-brain-barrier (bbb) in subjects with recurrent glioblastoma (rgbm) undergoing carboplatin monotherapy.

this is a phase 1/2, open-label, prospective, multi-center, single-arm study to establish the safety and feasibility of blood-brain-barrier disruption (bbbd) combined with intravenous carboplatin for the treatment of rgbm using the exablate neuro model 4000 type 2 system with microbubble resonators. adult glioblastoma subjects that are planned for carboplatin chemotherapy will be considered for study enrollment. eligible subjects will undergo up to 6 cycles of exablate bbbd procedures in conjunction with carboplatin chemotherapy.

Eligibility criteria:
inclusion criteria: * must be between 18-80 years old * histologically confirmed glioblastoma * planned for carboplatin monotherapy * be willing and able to provided written informed consent/asent * tumor progression after first line chemo radiation * recovered to grade 0 or 1 or pre-treatment baseline from clinically significant toxic effects of prior therapy * women of childbearing potential is confirmed not pregnant. male and female subjects utilize highly effective contraception * able to communicate verbally exclusion criteria: * acute intracranial hemorrhage * ferrous metallic implanted objects in the skull or brain * prior toxicity with carboplatin chemotherapy * women who are pregnant or breastfeeding * cerebellar spinal cord or brain stem tumor * known active hepatitis b or hepatitis c or hiv * significant depression not adequately controlled * has previously received anti-vegf or anti-vegf agents like avastin * cardiac disease or unstable hemodynamics * severe hypertension * history of a bleeding disorder, coagulopathy or with a history of spontaneous tumor hemorrhage * active drug or alcohol use disorder * known sensitivity to gadolinium-based contrast agents * known sensitivity or contraindications to ultrasound contrast agent or perflutren * unable to undergo mri or contraindications to mri such as non-mri compatible implanted devices * difficulty lying supine and still or severe claustrophobia which cannot be managed with medication * severely impaired renal function * right to left or bi-directional cardiac shunt * cranial or systemic infection requiring antibiotics * known additional malignancy that is progression or require active treatment

Keywords: exablate focused ultrasound rgbm
single dose pharmacokinetics of egalet® oxycodone

Conditions: Pain

Summary: the purpose of the study is to evaluate the pharmacokinetic profile of different egalet® oxycodone formulations and compare to a marketed oxycodone product.


Eligibility criteria:
main inclusion criteria: * ≥18 years and ≤55 years * non-smoker * bmi ≥18.0 and ≤30.0 main exclusion criteria: * any clinically significant abnormality or abnormal laboratory test results found during medical screening * history of allergic reactions to opioids or other related drugs * history of significant alcohol abuse or drug abuse * use of any drugs known to inhibit hepatic drug metabolism * pregnant or breast-feeding
group treatment for ptsd: a randomized clinical trial with veterans

Conditions: PTSD

Summary: the purpose of this study is to examine whether group cognitive behavioral treatment (gcbt) is efficacious in the treatment of ptsd in a sample of male veterans. veterans with a primary diagnosis of chronic ptsd will be randomly assigned to either gcbt or a supportive group treatment condition. both treatments will consist of 14, weekly sessions. assessment of ptsd and related symptoms will be conducted at pre-treatment, mid treatment, post-treatment, and 3-, 6-, - and 12-month follow-up.

the mental health needs of veterans within the va healthcare system are notable. with the substantial increase over the past 10 years in veterans seeking posttraumatic stress disorder (ptsd) treatment services, the va system is straining to accommodate these needs, relying heavily on group-based treatments. the proposed research will take the next step in the literature on group psychotherapy for ptsd by examining a group cognitive behavioral treatment (gcbt) program with promising pilot data. this application supports a randomized controlled trial, which will compare gcbt with supportive group psychotherapy (sgp). the trial will involve 196 male veterans with combat-related ptsd who will be randomly assigned to gcbt (n= 98) or sgp (n =98) to determine efficacy within a naturalistic care environment. outcome data will be collected pre-treatment, mid-treatment, post-treatment, and 3-, 6- and 12-month follow-up. two aims are included, one focusing on outcome with respect to ptsd symptom severity, the second focusing on treatment generalization to comorbid emotional disorders (major depressive disorder, generalized anxiety disorder, and alcohol abuse), and distress and impairment. data will be examined using latent growth curve modeling, with emphasis on determining efficacy and effectiveness. the information provided by the proposed project could assist in developing more effective care models for individuals with chronic ptsd from numerous traumatic experiences. additionally, this project represents an effort to move the literature on group-based treatments for ptsd ahead, through inclusion of advanced methodological and analytic approaches.

Eligibility criteria:
inclusion criteria: * primary diagnosis of dsm-iv (american psychiatric association, 2000) criteria for chronic, ptsd (symptoms lasting 3 months or more) * male, veteran * be free of psychosis and impaired cognitive function caused by traumatic brain injury or dementia exclusion criteria: * a current diagnosis of substance dependence or unstable bipolar disorder * currently involved in psychosocial treatment for ptsd

Keywords: randomized controlled trial ptsd cognitive behavioral treatment group treatment
a study to determine whether perioperative energy dynamics correlates with postoperative outcomes

Conditions: Abdominal Cancer; Pelvic Cancer

Summary: to validate a new method for assessing perioperative risk in the cancer patient undergoing major cancer surgery. in this proposed study researchers will: 1. measure preoperative energy reserve capacity (fitness) 2. determine if postoperative morbidity is a function of perioperative cardiopulmonary gas exchange metabolism

primary objective: • to characterize the effects of neoadjuvant therapy (chemotherapy, radiation therapy, and/or immunotherapy) on functional capacity in esophageal and lung cancer participants as measured by gas exchange parameters (%predicted at, %predicted p-vo2, vo2 at at \& peak exercise, oxygen pulse, δvo2/δwr, δve/δvco2) obtained from cpet before and after neoadjuvant therapy. secondary objectives: • to characterize changes in cpet measures in participants treated with chemotherapy, radiation therapy, and/or immunotherapy followed by surgery and correlate these changes with postoperative outcome.

Eligibility criteria:
inclusion criteria: * participants 18 years of age or older. * participants with newly diagnosed esophageal and lung cancer undergoing neoadjuvant chemotherapy, radiation therapy, and/or immunotherapy. * participants who have signed the consent form to participate in the study. * participants must have been evaluated in the perioperative evaluation and management (poem) center or by a staff anesthesiologist. * all laboratory and diagnostic evaluations required or used to evaluate the patient must be completed. all participants must be approved to undergo anesthesia by the standards of the poem center. * no samples belonging to vulnerable populations (children, pregnant women, cognitively impaired adults or prisoners) will be allowed from participation. exclusion criteria: * participant is under age 18. * participant is unwilling to sign consent. * participant is unable to exercise (bedridden or wheel chair bound). * participant is enrolled in another study deemed by the investigator to affect oxygen metabolic efficiency and not presently the standard of care at mdacc. * participant's condition is deemed unsatisfactory for surgery after the preanesthetic evaluation. * participant has had a myocardial infarction within three months of the preanesthetic evaluation or presents with new or unstable angina. * participant has a history of a cerebrovascular accident or transit ischemic attacks within three months of the preanesthetic evaluation. * participant has a history of a pulmonary embolic event within three months of the preanesthetic evaluation. * participant is known to have acute or chronic deep vein thrombosis. * participant is pregnant.

Keywords: abdominal cancer pelvic cancer perioperative energy dynamics cardiopulmonary exercise testing cpet
sasanlimab (pf-06801591, pd-1 inhibitor) in participants with advanced malignancies

Conditions: Advanced Malignancies; Non-small-cell Lung Cancer

Summary: this is a phase 1b/2 protocol to evaluate pharmacokinetics, safety, efficacy, and pharmacodynamics of pf-06801591, a programmed death-1(pd-1) antagonist monoclonal antibody (mab) in participants with advanced malignancies. this study consists of 2 parts: phase 1b part (dose escalation and dose expansion) in patients with advanced malignancies in asia and a global phase 2 part in non small cell lung cancer (nsclc) patients.


Eligibility criteria:
inclusion criteria: * age ≥18 years (≥ 20 years in japan; ≥ 19 years in south korea) * easter cooperative oncology group (ecog) performance status 0 or 1 * adequate bone marrow function, renal and liver functions phase 1b * histological or cytological diagnosis of advanced solid tumor with clinical evidence of response to anti-pd-1 or pd-l1 agent * participant must have received at least 1 prior line of therapy for recurrent or metastatic disease, and must have progressed/relapsed, be refractory, or intolerant to standard therapy approved for the specific tumor type phase 2 * participants must have a documented diagnosis of stage iii where participants are not candidates for surgical resection or definitive chemoradiation, or stage iv nsclc * egfr mutation, braf mutation, and alk or ros1 translocation/rearrangement are not permitted * participants whose tumor is known to be pd-l1 positive (tumor proportion score \[tps\] ≥1%) or unknown are eligible * up to 1 line of prior therapy in advanced or metastatic disease settings allowed * participant should not have received prior treatment with anti pd-1/pd-l1 drugs * at least one measurable lesion as defined by recist version 1.1 exclusion criteria: * participants with known symptomatic brain metastases requiring steroids * participants with interstitial lung disease history or complication * q-t interval corrected for heart rate qtc \> 450 msec for male participants or qtc \> 470 msec for female participants or qtc \> 480 msec in participants with right bundle branch block. * hypertension that cannot be controlled by medications (eg, systolic \> 150 mmhg and diastolic \> 90 mmhg) despite optimal medical therapy. * known or suspected hypersensitivity to active ingredient or excipients of the study drug. * history of grade ≥3 immune mediated ae (including ast/ alt elevations that where considered drug related and cytokine release syndrome \[crs\]) that was considered related to prior immune modulatory therapy (eg, immune checkpoint inhibitors, co-stimulatory agents, etc.) and required immunosuppressive therapy (for phase 1b only). * vaccination with live attenuated vaccines within 4 weeks prior to randomization is prohibited; however inactivated vaccines are permitted.

Keywords: advanced solid tumors nsclc
phase ii study of sbrt as treatment for oligometastases in prostate cancer

Conditions: Oligometastatic Prostate Cancer

Summary: this study aims to probe the effect of sbrt as a treatment oligometastases of prostate cancer, regardless of basal treatment received, and i know the response, biochemical control, the progression-free survival as well as their impact on quality of life. primary objective: local and symptomatic oligometastases control of prostate cancer treated by sbrt. secondary objectives: analyzing biochemical progression rates, progression-free survival, chemotherapy-free survival and overall survival. analyze toxicities and quality of life of patients before and after treatment


Eligibility criteria:
inclusion criteria: * patients with histologically confirmed prostate cancer, who are currently being oligometastases / oligorrecurrencia after primary treatment for their disease. * aged ≥ 18 years * time to biochemical recurrence more than 1 year * psa doubling time\> 3 months * less than 5 bone metastases location (including spinal) or lymph node. * without other metastases or recurrences by choline pet or / and nmr diffusion length. * signed and dated written informed consent form. exclusion criteria: * patients currently treatment with abiraterone, enzalutamide, chemotherapy, immunotherapy or radioisotopes. * patients unwilling or unable to comply with protocol requirements and scheduled visits.

Keywords: sbrt oligometastases prostate cancer
effects of ultra processed food on intestinal energy harvest

Conditions: Obesity and Overweight

Summary: ultra processed food is everywhere in modern society and may contain multiple ingredients that affect the way participants' bodies store energy. some studies have shown that eating a diet high in ultra processed foods leads to weight gain, but these foods have not been studied enough to understand why. recently, the gut microbiome has become a potential way to measure energy balance in the human body; this is done by measuring how many calories are in the stool. the investigators propose to test a very high ultra-processed food diet where 80% of calories are coming from ultra processed food and a low ultra processed food diet where 20% of the calories are coming from ultra processed food. this study will compare stool sample energy content of the two diets.

this study will recruit people with obesity who are otherwise healthy to participate in this study. each person will go through baseline testing before starting any of the diets. this consists of one blood draw, one metabolic test which requires each person to remain awake in a small, enclosed room that measures oxygen and carbon dioxide consumption, and one body composition test. participants will also meet with a study dietitian to review their diet, how to track their diet, and how to collect and ship the stool samples. each person will be assigned to either 80% or 20% level of ultra processed food in the diet to start and will continue this diet for two weeks. after the first diet phase, each participant will enter a washout period where they will return to eating however they wish and will not need to participate in any research activities. after the two weeks, each participant will return to begin another series of tests and begin the second two-week diet phase. the whole study will take approximately 9 weeks to complete.

Eligibility criteria:
inclusion criteria: * bmi 30-40kg/m2 * weight stable * able to download app and willing to use it for duration of study * does own grocery shopping * otherwise healthy exclusion criteria: * pregnancy * history of or planned bariatric surgery * history of anti obesity medications

Keywords: obesity ultra processed food energy balance