Kornimate/medical-research-clean huggingface dataset:
psychometric properties of the international trauma interview (iti) for icd-11 ptsd and cptsd

Conditions: Post Traumatic Stress Disorder (PTSD); Complex Post-Traumatic Stress Disorder (CPTSD)

Summary: the aim of the project is to evaluate the psychometric properties (e.g. validity, reliability) of the international trauma interview (iti) - german version. the iti is a structured clinical interview that corresponds to the icd-11 criteria for diagnosing both posttraumatic stress disorder (ptsd) and complex posttraumatic stress disorder (cptsd). eligible participants from psychiatric inpatient and outpatient facilities in switzerland who have provided informed will complete various self-report measures about trauma-related mental health complaints. in addition, the iti will be conducted by a trained clinician. lastly, information from the medical chart will be further used for scientific purpose. the overall assessment will take approximately 1-2 hours to complete.


Eligibility criteria:
study-specific inclusion criteria * structured diagnostic procedures upon hospital entry not yet started, except for orienting assessments * able to give informed consent as documented by signature * able to understand and communicate in german exclusion criteria * clinical signs for impaired cognitive abilities * other contraindications to undergo the clinical interview
high-resolution pet-ct imaging for surgical margin visualization

Conditions: Cancer; Solid Malignant Tumors

Summary: imaging will be exploratory and be used intraoperatively. there have been no discovered risks associated with the device to be used in this study, and none are anticipated given the diagnostic and non-invasive, 'ex vivo' nature of device use. of note, the surgical resection will proceed as per standard of care and will not be affected by the research protocol. potential benefit: imaging intra-operatively will ensure surgeons to identify at risk resection margins. time commitment: there are no additional visits that will be asked of you to partake in this study. drug is fda approved and exposure to radiation is minimal.

this pilot study explores the use of high-resolution pet imaging to identify surgical margins in solid tumors after removal. it evaluates the feasibility and potential of using pet-ct to assess tumor specimens and ensures radiation safety with a low-dose 18-fdg injection (20% of the standard dose). previous studies have shown good tumor visualization in breast, pancreatic, prostate, and head and neck tumors, supporting the method's proof-of-concept. this research aims to gather insights into its clinical usefulness across different cases

Eligibility criteria:
inclusion criteria: * biopsy confirmed diagnosis of any solid malignancy * diagnosis of any t stage, any subsite that are scheduled to undergo definitive en bloc surgical resection. patients with recurrent disease or a new primary will be allowed. * planned standard of care oncologic surgery with curative intent * male or female patients age ≥ 18 years * have life expectancy of more than 12 weeks * karnofsky performance status of at least 70% or ecog/zubrod level 1 * have acceptable glucose status (\<200 mg/dl) at day of surgery prior to 18f-fdg injection exclusion criteria: * general or local contraindications for resective surgery * women who are pregnant or breast-feeding * blood glucose level over 200 mg/dl prior to 18f-fdg infusion * any participation in other clinical trials or research study that involved a radiation exposure of more than 1 msv in the past year. if the participant had radiation exposure greater than 1 msv as soc, they would not be excluded unless the principal investigator determines that patient could be at risk.

Keywords: undergoing surgery xeos pet/ct imaging specimen scanner cancer margins
oxaliplatin in gastric cancer

Conditions: Stomach Neoplasms

Summary: to determine the objective response to oxaliplatin/5fu/leucovorin combination chemotherapy in patients with advanced unresectable or metastatic gastric cancer.


Eligibility criteria:
inclusion criteria: * ecog performance status of 0-2. * histologically proven gastric or gastro-esophageal junction adenocarcinoma. * at least unidimensional measurable disease. if a unique metastasis constitutes the only disease sign, it requires histological confirmation. * first line locally unresectable or metastatic gastric cancer. * relapsing gastric cancer after local and/or systemic treatment with a post-surgical period of at least 4 weeks, a post-adjuvant or neoadjuvant chemoradiotherapy period of at least 6 months. * serum bilirubin \< 2 mg/dl * serum creatinine \< or = 2 mg/dl * hemoglobin \> or = 10 g/dl * absolute neutrophil count \> or = 2000/dl * platelet count \>or = 100, 000/dl * ast/alt \< or = 2.5 time-fold the institutional normal upper limit * alkaline phosphatase \< or = 5 time-fold the institutional normal upper limit * imagenological evaluation of the patient at least 2 weeks prior to the drug infusion * laboratory tests at least 1 week prior to the first infusion * patient available for follow up and able to answer to the quality of life questionnaire exclusion criteria: * symptomatic sensorial peripheral neuropathy * uncontrolled concomitant disease * another malignant neoplastic disease diagnosed within the previous 5 years to the diagnosis of advanced or metastatic gastric cancer, with the exception of 'in situ' cervix carcinoma or non-melanoma skin cancer * concomitant antitumoral treatment * cerebral metastases * unstable heart disease, even though in treatment * myocardial infarction within the last 6 months * radiotherapy within the last 6 weeks, surgery within the last 4 weeks, or chemotherapy within the last 6 months. * pregnancy or nursing ( or women in reproductive life without adequate contraception) * significant neurological or psychiatric disorders.
impact of a group intervention on breast cancer patient's adjustment and emotion regulation at the end of treatment

Conditions: Breast Cancer

Summary: background: the end of treatment is for cancer patients the beginning of a critical rehabilitation period including numerous physical, emotional, professional and cognitive challenges. specific interventions adapted to this post-treatment period need thus to be designed. interventions such as group cognitive-behavioral therapy and hypnosis have been shown to be effective. however, moderate effect sizes, no comprehensive description of the treatment interventions and assessments relying only on self-report measures warrant further investigation. this study aims to assess, in breast cancer patients at the end of treatment, the impact of a group intervention combining cognitive-behavioral therapy and hypnosis versus a group intervention on patient's adjustment and emotion self-regulation. design: this is a two-armed, longitudinal, randomized controlled trial. breast cancer patients finishing their radiation therapy treatment will be randomized to either an immediate group intervention combining cognitive-behavioral therapy and hypnosis or a group intervention. patients will be assessed at three time points during the first year following the end of treatment: at 1 (t1), 6 (t2) and 12 (t3) months after the end of treatment. patients' adjustment will be assessed through questionnaires. patient emotion self-regulation ability will be assessed through their ability to respond both subjectively (self-reported emotional state) and objectively (heart rate) to two emotion self-regulation tasks. discussion: it is hypothesized that a group intervention combining cognitive-behavioral therapy and hypnosis will be more effective than a group intervention. results of this study will contribute to improving post-treatment care for breast cancer patients.


Eligibility criteria:
inclusion criteria: * non-metastatic breast cancer (in situ or invesive) * end of active treatments (surgery, chemotherapy and radiotherapy) * no recurrence nor palliative care * min. 18 years * able to speak french * willing to be randomized to study intervention group * accept to give their written informed consent exclusion criteria: * no cognitive dysfunction * no severe or uncontrolled psychiatric illness

Keywords: patients at the end of treatment
beacon tip sizing catheter and slip-cath beacon tip catheter study

Conditions: Stenosis; Bleed Intracranial; Stroke; TIA; Vascular Malformation; Pseudoaneurysm

Summary: this prospective observational post-market clinical study will collect data in the united states to primarily support the re-launch of the re-designed beacon tip sizing catheter and slip-catheter beacon tip catheter \& shuttle select slip-catheter (visceral and cerbral) for a conformité européenne (ce) mark application in the european union (eu). additionally, the data from this study may be used to support regulatory approval in other countries/regions. the purpose of this clinical study is to evaluate the safety and performance of these catheters in accordance with the intended use through the end of index procedure, and through 30 days post procedure, (as applicable as data is available) to ensure an acceptable benefit:risk ratio.


Eligibility criteria:
inclusion criteria: * a patient is deemed suitable for inclusion in this study if the patient undergoes a procedure using an applicable beacon tip catheter. exclusion criteria: * patient or his/her legally authorized representative objects to collection and processing of his/her data, or not willing to accept the use of an informed consent waiver or the data protection notice (if utilized).

Keywords: catheter beacon diagnostic imaging device sizing beacon tip slip cath
evaluation of ecpr survivors

Conditions: Cardiac Arrest; Cardiopulmonary Resuscitation; Extracorporeal Membrane Oxygenation Complication; Myocardial Infarction; Cardiogenic Shock

Summary: a cardiac arrest event has severe impact on the patient´s health-related quality of life. survival of cardiac arrest does not innately translate to favorable quality of life. in particular, highly invasive resuscitation strategies, including extracorporeal cardio-pulmonary resuscitation (ecpr) due to therapy-refractory cardiac arrest, may have impact on long-term outcomes. therefore, apart from acute medical treatment and physical rehabilitation, long-term effects on cardio-pulmonary, physical and neuro-psychiatric functions after cardiac arrest survival have to be evaluated and optimized. we plan to investigate a bundle of cardio-pulmonary, physical and neuro-psychiatric functions in patients who survived a therapy-refratory cardiac arrest with ecpr.


Eligibility criteria:
inclusion criteria: * adult patients * survival of cardiac arrest * use of extracorporeal cardiopulmonary resuscitation (ecpr) with veno-arterial extracorporeal membrane oxygenation (va-ecmo) or ecmella (va-ecmo and left-ventricular impella micro-axial pump) exclusion criteria: * non-adult patients * no cardiac arrest * no use of ecpr * inability to comply with follow-up
physical activity, knee joint loading and joint health

Conditions: Anterior Cruciate Ligament Injuries; Anterior Cruciate Ligament Rupture; Anterior Cruciate Ligament Tear; Post-traumatic Osteoarthritis; Anterior Cruciate Ligament Reconstruction

Summary: the purpose of this study is to investigate the association between time spent in moderate to vigorous physical activity and markers of cartilage metabolism in the years following anterior cruciate ligament reconstruction.

participants attend the laboratory on two or three occasions and wear accelerometers for the 10 days in between the first and second laboratory session. the first laboratory session involves urine sample collection, the completion of questionnaires, blood sample collection, acquisition of cross-sectional images of the thigh and calf, and a whole-body composition scan. the researchers will use the accelerometers at the wrist to measure time spent in moderate to vigorous physical activity, and the accelerometers at the ankle as an analogue for knee joint loading. the second laboratory session will consist of a 30-minute run on an instrumented treadmill (measures force of each step taken) whilst wearing non-invasive reflective markers, electromyography devices, and an accelerometer at the ankle. participants are also invited to undergo optional repeated blood sampling to measure levels of markers of cartilage production and breakdown during rest and in response to a 30-minute run. if participants volunteer for the optional repeated blood sampling, they will be asked to attend a third laboratory session where blood samples will be taken at 24 hours after the run in the second laboratory session.

Eligibility criteria:
inclusion criteria: 1. 18-39 years old (i.e., ≥18 and \<40 years old) 2. had an anterior cruciate ligament injury and reconstruction 1-7 years ago (i.e., ≥1 and ≤7 years ago) 3. can have sustained damage to meniscus or cartilage, or sustained bone bruising when injured anterior cruciate ligament 4. can participate regardless of the type of reconstruction surgery and if undergone meniscectomy 5. completed anterior cruciate ligament reconstruction rehabilitation and either a surgeon, doctor or physiotherapist has provided clearance to participate in physical activity 6. be able to attend the university of bath within 2 hours of waking exclusion criteria: 1. had another significant knee injury either before, at the same time, or after the anterior cruciate ligament injury (e.g., if they injured another ligament in their knee or had a fracture or dislocation) 2. injured the anterior cruciate ligament in both knees (bilateral acl injury) 3. have/are experiencing a musculoskeletal, cardiovascular, respiratory, immune, metabolic or neurological disease or disorder 4. under 18 or over 39 (i.e., ≥40) years of age 5. body mass index ≥40 kg/m² 6. pregnancy 7. positive responses to the physical activity readiness questionnaire (aside from any involved knee joint issues)

Keywords: physical activity knee joint loading cumulative load biomarkers musculoskeletal modelling patient reported outcomes
an efficacy, safety, and tolerability study of veligrotug (vrdn-001), in participants with chronic thyroid eye disease (ted) (thrive-2)

Conditions: Thyroid Eye Disease

Summary: this is a clinical trial assessing the efficacy, safety, and tolerability of an investigational drug, veligrotug (vrdn-001), in participants with chronic thyroid eye disease (ted).

this is a randomized (meaning participants will be assigned to study arms by chance), double-masked (meaning study doctor and participant will not know which study arm participant is assigned to), placebo-controlled study that will include participants with chronic ted. the key objectives of this study are to determine if veligrotug (vrdn-001) is efficacious, safe, and tolerable when administered as 5 iv infusions given every 3 weeks for a total of 12 weeks in participants with chronic ted

Eligibility criteria:
key inclusion criteria: * must have moderate to severe chronic ted with documented evidence of ocular symptoms or signs that began greater than 15 months prior to screening * must have had a clinical diagnosis of ted, with any cas (0-7) * must agree to use highly effective contraception as specified in the protocol * female ted participants must have a negative serum pregnancy test at screening key exclusion criteria: * must not have received prior treatment with another anti-igf-1r therapy * must not have received systemic corticosteroids for any condition, including ted, or selenium within 2 weeks prior to first dose * must not have received other immunosuppressive drugs or another investigational agent for any condition, including ted, or any other therapy for ted, within 8 weeks prior to first dose * must not have received radioactive iodine (rai) treatment within 8 weeks prior to first dose * must not have a pre-existing ophthalmic condition in the study eye that in the opinion of the study doctor would confound interpretation of the study results * must not have had previous orbital irradiation or decompression surgery for ted to the study eye's orbit * must not have a history of inflammatory bowel disease * must not have an abnormal hearing test before first dose or history of ear conditions considered clinically significant by the study doctor * female ted participants must not be pregnant or lactating

Keywords: graves thyroid eye disease thyroid-associated ophthalmopathy dysthyroid ophthalmopathy graves eye disease graves orbitopathy myopathic ophthalmopathy congestive ophthalmopathy edematous ophthalmopathy infiltrative ophthalmopathy ted
clareon intraocular lens stability in vitrectomy patients: clove study

Conditions: Senile Cataract; Epiretinal Membrane; Vitreous Hemorrhage

Summary: this prospective randomized controlled trial will be conducted to investigate clareon intraocular lens (iol) stability in vitrectomy patients. the investigator plans to target the patients undergoing cataract surgery. a randomized study will be conducted with 2 arms, one with clareon iol versus a second arm using the tecnis 1 in this non-inferiority study, the investigator will compare clareon iol from alcon with the existing tecnis 1 iol from precision lens which is the commonly used intraocular lens in combined vitrectomy cases in hong kong.

all patients will undergo standard phacoemulsification cataract extraction with clareon iol or tecnis 1 iol by an experienced cataract surgeon. followed by vitrectomy to treat either, epiretinal membrane or vitreous hemorrhage. all patients returned for follow-up visits at 1 week, 1 month, and 6 months after surgery for ophthalmic assessments including: * visual acuity measured by early treatment of diabetic retinopathy study (etdrs) chart * refraction * axial movement and tilt measured by pentacam (oculus optikgeräte gmbh, germany) using the sasaki method. the scheimpflug image of the horizontal cross-section and the vertical cross-section of the iol will be selected for measurement. central acd will be measured as the distance between the central corneal posterior endothelium to the anterior surface of iol. the subtraction in acd between two visits indicated forward or backward axial movement of the iol. * decentration will be measured from the center of the iol anterior surface to the pupillary axis, which will be perpendicular to the line between the two anterior chamber angles and through the midpoint of the line. * tilt will be measured as the angle between the iol axis and the perpendicular visual axis. * any surgical complications and post-op complications will be documented.

Eligibility criteria:
inclusion criteria: * patients with a diagnosis of senile cataracts and epiretinal membranes or vitreous hemorrhage * age between 50 and 80 years. exclusion criteria: * diagnosis of vision-impairing diseases including uveitis, glaucoma and corneal pathologies resulting in high astigmatism, severe refractive error (preoperative spherical equivalent of either eye \>-6.00d or +5.00d); * diagnosis of possible lenses instability including history of ocular trauma, pseudoexfoliation syndrome; past refractive surgery or other ophthalmic surgery; * known capsular or zonular disorders that might affect the post-operative centration of iols, e.g., pseudo-exfoliation syndrome or marfan syndrome; * surgical complications including severe hyphema, iris injury, repeated iol implantation during surgery, failure to achieve in-the-bag iol implantation, posterior capsular rupture, usage of tamponade (gas or oil) and corneal sutures. * difficulty in obtaining iol measurements (eg. small pupil, corneal opacities, patient cooperation)
behavioral intervention for low income depressed smokers in drug treatment

Conditions: Cigarette Smoking; Drug Use

Summary: the objective of the proposed project is to develop a novel, behavioral approach to smoking cessation that can be integrated with residential drug use treatment for low income substance using smokers with elevated depressive symptoms. the approach utilizes behavioral activation strategies which have been shown to reduce smoking among community samples and which can be easily targeted for the particular needs of low income substance users.

this project will take place in two phases. in the first phase, the investigators will utilize pilot testing with 10 participants (two groups of 5 individuals) to integrate two existing behavioral activation manuals to develop the behavioral activation for drug abusing smokers (ba-das). in phase ii, the investigators will randomize 80 patients to either: 1) standard smoking cessation treatment (st) and nicotine replacement therapy (nrt) or 2) ba-das (which includes st and nrt). based on the outcome of this preliminary trial, the ba-das protocol will be further refined and readied for larger-scale clinical trials to develop a comprehensive approach to treating smoking among low income, largely minority, depressed smokers in residential drug use treatment, which may be instrumental in reducing smoking among this especially at risk group.

Eligibility criteria:
inclusion criteria: * between 18 and 65 years of age * regular smoker for at least one year * currently smoking an average ≥ 10 cigarettes (also cigarellos, bidis, or black and milds included) per day * report motivation to quit smoking in the next month * report elevated depressive symptoms exclusion criteria: * physical concerns contraindicating the nicotine patch * limited mental competency and/or the inability to give informed, voluntary, written consent to participate * current use of pharmacotherapy for smoking cessation not provided by the researchers during the quit attempt * use of psychotropic medication for \< 3 months * primary use of other tobacco products (specifically: chewing tobacco, cigars, and pipes) * psychotic symptoms * current pregnancy or plans to become pregnant within the following three months

Keywords: cigarette smoking drug use depressed mood
unilateral versus bilateral tlif for degenerative lumbar spondylolisthesis

Conditions: Degenerative Spondylolisthesis; Transforaminal Lumbar Interbody Fusion

Summary: a prospective randomized controlled trial for comparison of radiologic outcomes of "single level transforaminal interbody fusion(tlif) technique via unilateral versus bilateral facetectomy for the treatment of lumbar degenerative spondylolisthesis

traditionally many spine surgeons prefer single level tlif surgery via bilateral facetectomy for increasing union rate. our hypothesis - "single level tlif via unilateral facetectomy is sufficient for achieve successful fusion rate"

Eligibility criteria:
inclusion criteria: * lumbar degenerative spondylolisthesis * indicated for surgery exclusion criteria: * not agreed for the study
comparison of 2 different hook-up protocols to perform home-based polysomnography

Conditions: Sleep Disordered-breathing

Summary: comparison of 2 hook-up protocols to perform home-based sleep studies in patients suspected of sleep-disordered breathing. first one: hook-up is performed in the hospital, around 4 pm, and the patient go home with the portable monitoring. second one: hook-up is performed home, around 7 pm, and the patient has not to move after hook-up.

all the patients will undergo 2 polysomnographies, according to two different hook-up protocols, within 2 weeks. order of the exams will be randomized. we hypothesised that quality of recording is better when hook-up is performed at home. final polysomnographic diagnosis, with the 2 different techniques, must be similar.

Eligibility criteria:
inclusion criteria: * adult, * suspects of sdb, * leaving home, * at maximum 30km around the hospital exclusion criteria: * suspicion of other sleep disorders * children

Keywords: polysomnography portable monitoring sleep sleep disordered breathing home based polysomnography