Kornimate/medical-research-clean huggingface dataset:
adaptive mr-guided sbrt for localized prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to evaluate a technical feasibility of mr-guided sbrt fraction dose adaptation for low-risk, intermediate-risk and low-volume metastatic prostate cancer. .

hypofractionated sbrt to 36.25 gy in 5 fractions (fraction dose 7.25 gy) for low- and intermediate risk prostate cancer is standard of care. using higher fraction doses that might be beneficial for disease control is not safe in all patients, unless adaptive treatment is performed. in this clinical trial the feasibility of online mr-guided sbrt fraction dose adaptation (between 7 and 8 gy) for prostate cancer will be investigated. a fraction dose to the planning target volume (ptv) will be adapted to organs-at-risk (oar) geometry (position, shape and volume) on online planning mri scans of the treatment day ("geometry-of-the-day"). thus the investigators hope to maximize treatment individualization.

Eligibility criteria:
inclusion criteria: * written informed consent according to swiss law and ich/gcp regulations before any trial specific procedures; * males; * histologically confirmed adenocarcinoma of the prostate; * low (grade group 1 \[gleason score ≤6\], clinical stage t1-2a n0 m0, and psa \< 10 ng/ml) and intermediate (grade group 2-3 \[gleason score 7\], clinical stage t2b-2c n0 m0, psa 10-20 ng/ml) risk prostate cancer with indications for sbrt with curative intent; * newly diagnosed low-volume metastatic prostate cancer with indications for sbrt, in whom metastatic disease was confirmed on a bone scintigraphic scan and soft-tissue imaging done within 3 months of starting androgen deprivation therapy (adt); * ipss \<15; * age: ≥ 18 years old; * karnofsky performance status ≥70; * patients able to tolerate long (approximately 60 minutes) treatment time; * patients who are willing and able to comply with scheduled visits, treatment, and other trial procedures. exclusion criteria: * previous radical treatment for prostate cancer - either radiation therapy (external or brachytherapy), surgery, tur-p, cryosurgery, or hifu; * contraindications for mri, e.g., patients with metal fragments or implanted devices that are not mr compatible such as certain types of pacemakers and aneurysm clips or severe claustrophobia; * lack of safe contraception; * known or suspected non-compliance, drug or alcohol abuse; * inability to follow the procedures of the trial, e.g. due to language problems of the participant; * enrolment of the investigator, his/her family members, employees and other dependent persons.

Keywords: sbrt mr-linac adaptive radiotherapy prostate cancer
mri-guided focal laser ablation

Conditions: Prostate Cancer

Summary: magnetic resonance imaging-guided focal laser ablation of prostate cancer.


Eligibility criteria:
inclusion criteria: * mri visible index lesion (on t2-weighted mr imaging or diffusion weighted imaging); * maximum mri visible lesion size is ≤ 15 mm large axis; * life expectancy at inclusion of more 10 years; * diagnosis of prostate cancer confirmed by targeted biopsy using trus-mri fusion or in-bore mri guided biopsies; * criteria of low and intermediate risk of progression and eligibility for focal therapy (clinical stage of maximum t2c, maximum biopsy gleason score of 4 + 3 on targeted biopsies, serum prostate specific antigen \< 15 ng/ml); * patient accepting to be included in an active surveillance protocol at the end of the study, in accordance with the recommendations of good practice. exclusion criteria: * history of prostate surgery; * history of radiation therapy or pelvic trauma; history of proved acute or chronic prostatitis; * history of tumor in the preceding 5 years (excluded: non-metastatic basal cell skin cancer); * severe urinary symptoms associated with benign hyperplasia of the prostate, and defined by an ipss score \> 18; * tumor with mri signs of extra-capsular extension or invasion of the seminal vesicles; * maximum cancer core length \>3 mm and/or maximum gleason score of 3+4 on systematic biopsies outside the visible tumor area on mpmri; * impossibility to obtain a valid informed consent; * patients unable to undergo mr imaging, including those with contra-indications; * contra-indications to mr guided focal laser therapy (colitis ulcerosa, rectal pathology or abdomino perineal resection); * metallic hip implant or any other metallic implant or device that distorts local magnetic field and compromises the quality of mr imaging; * patients with evidence for nodal or metastatic disease; * patients with an estimated glomerular filtration ratio (egfr) \< 40 ml/min/1.73 m2.

Keywords: focal laser ablation
open, randomized, two way crossover study comparing the effect of esomeprazole adminstered orally and iv

Conditions: Gastroesophageal Reflux Disease

Summary: the purpose of this study is to examine the effects of nexium at a dose of 20mg administered orally compared to intravenously on the maximum acid output in subjects with symptoms of gastroesophageal reflux disease (gerd).


Eligibility criteria:
inclusion criteria: * heartburn on 2 out of the last 7 days prior to screening or a diagnosis of gerd (with or without a diagnosis of erosive eosphagitis) or a documented diagnosis of gerd within 6 months prior to screening, with or without a history of ee. * body mass index within the limits specified in the protocol. exclusion criteria: * history of esophageal, duodenal or gastric surgery * history of severe liver disease. * any other significant disease or pathology judged to be clinically significant by the investigator.

Keywords: gastroesophageal reflux disease nexium esomeprazole administration methods.
obstructive sleep apnea, retinal vein occlusion, retinal artery occlusion

Conditions: Retinal Vascular Occlusion

Summary: obstructive sleep apnea is a common disorder linked to serious long-term adverse health consequences; such as hypertension, metabolic dysfunction, cardiovascular disease. retinal vascular occlusion is related to many systemic illnesses especially hypertension. obstructive sleep apnea is also related to vascular endothelial dysfunction and vascular endothelial growth factor elevation which causes vision threatening complications of retinal vascular occlusion. therefore the relationship between obstructive sleep apnea and retinal vascular occlusion should be studied.


Eligibility criteria:
inclusion criteria: * any patient who visits outpatient clinic and diagnosed as retinal vascular occlusion which occurred within recent 3 months exclusion criteria: * any ocular disease other than retinal vascular occlusion (for example: floppy eyelid syndrome, uveitis, glaucoma, other retinal diseases) * patient who has difficulty answering the questionnaires or portable sleep monitoring * patient who refuses the study enroll
enhanced support for initiation and participation in a food is medicine program

Conditions: Cardiac Rehabilitation; Nutrition, Healthy; Nutrition Poor

Summary: the purpose of this research is to see if offering more navigation and text-message support will help increase participation and engagement in a food is medicine program. the study will recruit people currently participating in cardiac rehabilitation. people will be randomly assigned to 1 of 4 study groups: navigation, text-messaging, both, or neither. people will complete surveys at the start of the study and after 3 months. after 3 months, we will compare how many food is medicine meals or groceries people in each group received.


Eligibility criteria:
inclusion criteria 1. age 18 or older 2. participating in ucsf cardiac rehabilitation 3. able to communicate in english or spanish 4. resident of san francisco county exclusion criteria 1. enrolled in hospice 2. unable to consent for self

Keywords: food insecurity nutrition insecurity food is medicine
online brief cbt intervention for women with pcos

Conditions: PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries; Depression, Anxiety; Self Esteem

Summary: primary objective: -to study if an online individual brief cbt (group a) intervention is effective for psychological distress (anxiety and depression) compared to a cau group in patients with pcos at 3 and 6 months relative to baseline. secondary objective(s): 1. to study if an online group based brief cbt (group b) is more effective for anxiety and depression compared to cau in patients with pcos at 3 and 6 months relative to baseline. 2. to determine if an online individual brief cbt (group a) is effective for improvements in qol, coping strategies, body image and sleep quality compared to cau in patients with pcos at 3 and 6 months relative to baseline. 3. to determine if an group based brief cbt (group b) is more effective for improvements in qol, coping strategies, body image and sleep quality compared to cau in patients with pcos at 3 and 6 months relative to baseline. 4. if a and b are effective compared to cau, we will compare online individual brief cbt (group a) to online group based brief cbt (group b) for anxiety and depression, qol, coping strategies, body image and sleep quality compared to in patients with pcos at 3 and 6 months relative to baseline.

the online brief cbt intervention is designed to address three problems that have often been reported in women with pcos. therefore, the program contains three themes: psychoeducation about pcos; traditional cbt and problem-solving therapy. participants are randomized into one of three groups: 1. individual treatment (a) 2. group treatment (b) 3. care as usual (cau) treatment a and b include 5 sessions divided over a period of 3 months: week 1: session 1 +homework assignments week 3: session 2 +homework assignments week 5: session 3 +homework assignments week 8: session 4 +homework assignments week 12: session 5 +homework assignments the cau group receives standard treatment for depressive symptoms from their general practitioner (gp).

Eligibility criteria:
inclusion criteria: * women with a confirmed diagnosis of pcos based on the rotterdam criteria * body mass index (bmi) ≥18.5 kg/m2 * aged 18-55 years. * mild depressive symptoms or anxiety scores based on the hospital anxiety and depression scale (hads) and/or a negative body image based on the body cathexis scale (bcs). exclusion criteria: * pregnancy * current treatment for clinical depression, anxiety disorders or eating disorders * suicidality (indicated by a score \>2 on the beck depression inventory ii suicide item) * having an endocrine disease (diabetes mellitus, thyroid function disorders, cushing's disease, adrenal tumors, and congenital adrenal hyperplasia) * inability to speak, read or write dutch.
voicelove: an app-based communication tool designed to address delirium and improve family engagement and patient/family satisfaction in critically ill patients (communicate)

Conditions: Critical Illness; Intensive Care Medicine

Summary: voicelove is a phone application allowing family and patients to share information in a secure platform. this project will compare the voicelove app to usual care to learn about whether voicelove improves patient-family communication, family engagement, and icu delirium.

voicelove is a novel, hipaa compliant mobile phone application that enables families and patients to securely exchange and archive voice messages in real-time. for patients who are intubated or otherwise unable to communicate, voicelove allows family members to deliver real-time voice messages when they are away from the bedside without relying on the clinical team to coordinate calls. the investigator group has recently completed formative usability testing of the voicelove application with a variety of icu stakeholders including family members, bedside icu nurses, and icu physicians to refine and optimize the app for clinical use in the icu. during usability testing, stakeholders overall viewed the app favorably and expressed interest in tools to enhance communication in the icu. as compared to traditional methods of communication, stakeholders identified the ability to customize messaging by unique family groups and to archive and replay messages as strengths. while promising as a tool to improve family engagement in the icu, it has yet to undergo evaluation in the icu to assess feasibility and acceptability of use. the goal in this prospective, mixed method randomized control trial (rct) is to compare voicelove implementation to usual care to investigate the effect of voicelove on optimizing patient-family communication, family engagement, and icu delirium prevalence.

Eligibility criteria:
inclusion criteria only patients who meet inclusion criteria, have no exclusion criteria, and consent for participation will advance to the interventional trial phase (i.e., the randomization phase) of the study. patients will be eligible for inclusion in the pre-randomization phase of the study (i.e., presented for study consent) if they are: 1. adult patient ≥18 years old 2. admitted to medical or coronary icu 3. intubated on mechanical ventilation with expected intubation of \> 24 hours exclusion criteria patients will be excluded (i.e., not consented) for any of the following reasons: 1. inability to obtain informed consent * attending physician refusal * patient and/or surrogate refusal * patient unable to consent and no surrogate available 2. acute or chronic neurologic deficit precluding cam-icu assessments 3. inability to understand english 4. current enrollment in a study that does not allow co-enrollment 5. prisoners 6. expected death or comfort measures within 24 hours of enrollment or lack of commitment to intervention by family or the medical team (e.g., likely to withdraw life support measures within 24 hours of enrollment). 7. bilateral deafness
customized 3d printed oral stents during head and neck radiotherapy

Conditions: Head and Neck Carcinoma; Malignant Parotid Gland Neoplasm; Maxillary Sinus Carcinoma; Nasal Cavity Carcinoma; Oral Cavity Carcinoma; Tongue Carcinoma; Tonsillar Carcinoma

Summary: this clinical trial studies the effect of customized 3 dimensional (3d) printed oral tents on patients with head and neck cancer who are receiving radiotherapy. oral stents are made from the impression of patients' mouth and cover patients' teeth and gums during radiation therapy. a customized, 3d-printed oral stent may help to reduce mouth blisters and/or sores that may develop in patients while receiving head and neck radiation therapy.

primary objective: i. to evaluate the acute mucositis rates in non-target mucosa of patients who receive head and neck radiation with or without a customized 3d printed oral stent. secondary objectives: i. to record patient reported outcomes during radiotherapy. ii. to evaluate patient narcotic use during radiotherapy. iii. to evaluate the imaging and dosimetric differences in head and neck radiotherapy with and without a customized 3d printed oral stent. outline: patients are randomized to 1 of 2 arms. arm i: patients wear 3d printed oral stent during standard of care radiotherapy. arm ii: patients receive standard of care during treatment.

Eligibility criteria:
inclusion criteria: * participant is dispositioned to receive 5-7 weeks of definitive or adjuvant radiotherapy for treatment of a diagnosed head and neck malignancy * age 18 or older * ecog ps 0-2 * the participant will receive either (a) radiation alone or (b) radiation with concurrent chemotherapy of any kind(s) * signed study-specific consent form exclusion criteria: * prior head and neck radiotherapy * participants is unable to fit a tongue-lateralizing or tongue-depressing stent * severe trismus with an incisal opening of \<10 mm * inability to comply with the study procedures * participants younger than 18 years of age * participants must not be pregnant * cognitively impaired subjects
the effect of single dose d-cycloserine on cognitive outcome in moderate traumatic brain injury (tbi) patients

Conditions: Traumatic Brain Injury

Summary: in this study of patients with moderate traumatic brain injury with frontal brain contusions patients will be randomized to treatment with a single dose of either d-cycloserine or placebo given 48-72 hours after injury. patients will undergo intensive neurocognitive testing at 3 and 6 months after injury to assess whether treatment with a single dose of d-cycloserine improves cognitive outcome after moderate brain injury.


Eligibility criteria:
inclusion criteria: 1. tbi diagnosed by history and/or clinical examination with presenting gcs between 9 -13 2. age between 18 and 55 years 3. frontal cerebral contusion(s) located in the frontal cortex and/or traumatic subarachnoid hemorrhage on initial ct scan 4. prior to randomization, patient is able to swallow an orally administered tablet or has a nasogastric tube in place per medical indication 5. informed consent will be obtained in those patients who have regained full cognition and judgment following their injury and are fully capable of understanding the study protocol, its risks and potential benefits, and of giving informed consent for participation in the study. in any patient that has not regained full cognition and judgment, only a temporary legal guardian (apotropos) appointed by an authorized judge that has been given a full explanation of the study protocol, its risks and potential benefits will be authorized to give informed consent for participation in the study. exclusion criteria: 1. penetrating brain injury 2. any traumatic intracranial lesion requiring neurosurgical intervention prior to time of randomization 3. other severe systemic injuries leading to severe hypotension, hemodynamic instability following initial resuscitation (sbp \< 90 mmhg), severe hypoxia. 4. intubation lasting \> 12 hours prior to randomization 5. suspected or confirmed pregnancy or lactating women 6. any spinal cord injury 7. known or ct scan evidence of previous major cerebral damage 8. any severe concomitant condition (malignancy, renal, hepatic, or major psychiatric disorder) 9. known treatment with another investigational drug within 30 days of injury 10. known contraindication to enteral administration of drug prior to randomization (gi bleed, ileus, severe abdominal injury, etc.) 11. known contraindication to placement of a nasogastric tube in patients unable to swallow an orally administered tablet

Keywords: moderate traumatic brain injury brain contusion
expanded access treatment protocol with dca for patients with pdcd

Conditions: Pyruvate Dehydrogenase Complex Deficiency

Summary: expanded access (ea) will provide a transition to continue therapy for those patients who are currently in the open label extension of the phase iii study, sl 1009-01, while also allowing new patients diagnosed with pdcd who meet the eligibility criteria to also have access to therapy that would be otherwise unavailable.

expanded access (ea) will provide a transition to continue therapy for those patients who are currently in the open label extension of the phase iii study, sl 1009-01, while also allowing new patients diagnosed with pdcd who meet the eligibility criteria to also have access to therapy that would be otherwise unavailable. the expanded access program (eap) will also allow the sponsor to extend the collection of long term safety data for the current open label patients, while also expanding to an additional population of patients beyond those currently in the sl 1009-01 study.

Eligibility criteria:
inclusion criteria: 1. ages 0 through adulthood 2. presence of characteristic clinical or metabolic features of pdcd and 3. presence of a known pathogenic mutation of a gene that is specifically associated with pdc (pdha1, pdhb, dlat, pdhx, dld). 4. females of reproductive age must be willing to use an effective method of barrier contraception for the duration of the study.- exclusion criteria: 1. a genetic mitochondrial disease other than those stipulated under inclusion criteria 2. primary, defined organic acidurias other than lactic acidosis (e.g., propionic aciduria) 3. primary disorders of amino acid metabolism 4. primary disorders of fatty acid oxidation 5. secondary lactic acidosis due to impaired oxygenation or circulation (e.g., due to severe cardiomyopathy or congenital heart defects) 6. malabsorption syndromes associated with d-lactic acidosis 7. renal insufficiency, defined as 1) a requirement for chronic dialysis or 2) serum creatinine ≥ 1.2 mg/dl or creatinine clearance \<60 ml/min 8. primary hepatic disease unrelated to pdcd 9. pregnancy or breast feeding -

Keywords: pdcd
a contemporary review of surgical approaches in pelvic exenterative surgery

Conditions: Pelvic Exenteration; Advanced Pelvic Malignancy; Locally Advanced Rectal Cancer

Summary: minimally-invasive surgery (mis) techniques have revolutionised the approach to rectal cancer surgery. with increasing experience, surgeons have began to utilise these platforms increasingly in the context of pelvic exenteration (pe). this observational retrospective review plans to assess the volume of pe being performed on a global basis and to assess the comparative outcomes associated with each technique in order to assess the optimal approach to radical pelvic surgery.

pelvic exenteration (extended pelvic multi-visceral resection) is a radical procedure that offers potential long-term cure in appropriately selected cases of locally advanced and recurrent pelvic cancers. it was first described by alexander brunschwig in 1948 as a viable palliative option for advanced gynaecological cancer. however, over the last 70 years, changes in surgical oncology practices have seen its role extended to include other advanced non-gynaecological cancers (locally advanced colorectal, urological, and sarcomatous neoplasms). although these procedures pose a significant challenge for the operating surgeon, improved surgical techniques, technology, and reconstructive options have facilitated more radical resections. despite improved surgical options, patients still have considerable post-operative morbidity and negative impact to quality of life. however, non-surgical management options result in poor prognosis with only 3% survival at five-years. pelvic exenteration in appropriately-selected patients offers the only hope of long-term survival. over the last few decades with improved perioperative management and better surgical techniques, more aggressive visceral, soft tissue and bony resections are performed. the development of minimally invasive surgery (mis) platforms has also evolved substantially, especially regarding pelvic surgery. there are some recent sporadic (low-volume) reports highlighting the potential role for mis exenterative surgery, however many reports have been heterogeneous and single-centre. the aim of this retrospective review is to compare the volume, disease characteristics and surgical outcomes between open, laparoscopic and robotic pelvic exenterations, and to assess the initial experience of mis platforms in multiple specialist centres worldwide.

Eligibility criteria:
inclusion criteria: * histologically proven locally advanced or recurrent rectal cancer * aged over 18 years * undergoing a multi-visceral extended pelvic resection * procedure took place within the specified timeframe (july 2016 - july 2021) exclusion criteria: * extra-pelvic/ non-resectable metastatic or peritoneal disease * palliative pelvic exenteration * insufficient patient follow-up data