Kornimate/medical-research-clean huggingface dataset:
the personal concerns inventory study (pci)

Conditions: Personality Disorders

Summary: services for people with personality disorders are challenged by how to engage clients in therapy. high non-completion rates have major cost-efficiency implications, but more worrying is that drop-out may be associated with negative outcomes for clients. the investigators have developed a motivational intervention that helps people focus on their valued and attainable life goals and consider how therapy could help with goal attainment.one way to improve retention in treatment is to deliver pre-therapy motivational preparation interviews. the primary aim of our proposed research is to gather information to determine whether a randomised controlled trial of a goal-based motivational intervention is feasible in a community personality disorder treatment service.

the investigators aim to work with community adults with personality disorder. referrals to nottinghamshire nhs trust's community personality disorder service will be eligible for inclusion. after initial assessment for suitability for the service, patients will be randomised to receive the motivational interview plus treatment as usual or treatment as usual only. the investigators aim to recruit 100 participants over 1½ years. the comparison is between a motivational intervention called the personal concerns inventory plus treatment as usual and and treatment as usual only in the client preparation phase. the feasibility measures are (1) the recruitment rate to a goal-based motivational interview plus treatment as usual or treatment as usual only, and (2) the acceptability of the intervention to clients and therapists. the investigators will also develop measures to assess the processes by which the intervention may have an effect, and assess the cost of the intervention compared with treatment as usual.

Eligibility criteria:
inclusion criteria: * referred to the nottinghamshire personality disorder and development network * opted to attend group sessions within the nottinghamshire personality disorder and development network * aged 18 or over. * proficiency in spoken english * capacity to provide valid informed consent exclusion criteria: * currently enrolled in another trial

Keywords: personality disorders personal concerns inventory non completion
advanced methods for cancer detection by vaginal screening

Conditions: Ovarian Cancer; Endometrial Cancer

Summary: this pilot study is the first step in the development of an new assay that may be further tested as a screening method for ovarian and endometrial cancers.

most high grade ovarian cancers originate in the fallopian tubes. since the lining of the fallopian tube opens into the uterine cavity cancer cells from ovarian/fallopian tube cancers can travel through the uterus to the cervix and vagina. likewise, endometrial cancer cells shed through the cervix into the vagina. it may be possible to develop a screening test for ovarian and endometrial cancers by collecting vaginal cells.

Eligibility criteria:
inclusion criteria: ovarian cancer and endometrial cancer cases: 1. women age 19 or older. 2. histologically confirmed high grade serous cancer (had a pre-operative core biopsy) of ovarian/fallopian tube/peritoneal origin or histo-cytologically confirmed endometrial cancer, not yet treated by surgery or chemotherapy. 3. give consent to access primary tumour tissue following surgery or biopsy. healthy participants: 1) healthy women between the ages of 19 and 60. exclusion criteria: ovarian cancer and endometrial cancer cases: 1. women with self-reported, known pregnancy. healthy participants: 2. women with a prior diagnosis of gynecologic malignancy (ovarian, endometrial, cervical, or vulvar cancer) will be excluded. 3. women who report irregular bleeding (spotting between menstrual cycles, or post-menopausal bleeding), or who have self-reported gynecologic concerns (e.g. pelvic pain, pelvic masses, dyspareunia) or have had a recent evaluation for gynecologic concerns (consultation with a gynecologist, pelvic ultrasound, endometrial biopsy) are ineligible. 4. women with known lynch syndrome and/or brca1 or brca2 germline mutations will not be eligible to participate as healthy volunteers for this study. 5. women with self-reported, known pregnancy.
outcomes of makoplasty patellofemoral arthroplasty in younger active patients

Conditions: Osteoarthritis, Knee

Summary: the primary purpose of this investigation is to report the short-term clinical outcomes (2-3 years) of patellofemoral arthroplasty implanted using the makoplasty knee resurfacing system.

the primary purpose of this investigation is to report the short-term clinical outcomes of patellofemoral arthroplasty implanted using the makoplasty knee resurfacing system. the secondary purpose is to compare the short-term outcomes, complication rates, and survival rates of this operation to those of our historical controls of patients who underwent either osteochondral autograft transfer or autologous chondrocyte implantation for full-thickness patellofemoral articular cartilage lesions. the investigators believe these data will provide strong evidence to improve the selection criteria for patellofemoral arthroplasty. all patients will complete validated questionnaires from the cincinnati knee rating system, including the sports activity and function form, the occupational rating form, and the symptom rating form. patients will also complete the sf-12 general health questionnaire. in addition to the above mentioned rating systems, patients will also complete questionnaires on post-surgical expectations and general fitness level.

Eligibility criteria:
inclusion criteria: * arthroscopically demonstrated localized and isolated full-thickness articular cartilage lesions (grade 2b or 3a-b as defined by noyes \& stabler9) on the patellofemoral joint. * lesion is symptomatic as defined by pain, swelling, locking, or catching that affects daily activities. * patient provides informed consent. * patient agrees to comply with postoperative rehabilitation program. exclusion criteria: * obesity (body mass index greater than 35). * arthroscopically demonstrated full-thickness articular cartilage lesions (grade 2b or 3a-b) in the other compartments of the knee. * uncorrected varus or valgus malalignment * uncorrected knee joint instability * knee arthrofibrosis * patient unwilling to comply with postoperative rehabilitation * significant muscular atrophy and weakness that does not respond to rehabilitation * history of alcohol or drug abuse within 3 years of the operation. * disabling or widespread osteoarthritis or other joint disease in any other joint. * presence of a significant connective tissue disease, autoimmune disease, hiv-positive, or immune deficiency syndrome. * any contraindications to surgery or other medical disorder that in the opinion of the principal investigator would interfere with the conduct of the study.
audiovisuell distraction via 2d videoglasses during catheter ablation procedures in cardiac rhythm disorders.

Conditions: Rhythm; Disorder

Summary: in this randomized controlled trial, amount of sedation exposure and patient satisfaction is evaluated in patients undergoing catheter ablation for rhythm disorders via an audiovisual distraction. patients are randomized into intervention group (adiovisual distraction) or controll (no intervention).

study conduct: after the patient has been informed and given written consent to participate in the study, the patients are randomized. they are either assigned to the control group (in which catheter ablation will take place without video glasses as before) or to the intervention group in which they receive the video glasses during ablation. the randomization into the two groups is done by random allocation. the patients in the intervention group receive instruction on how to use the video glasses and can familiarize themselves with them. before the patient (as well in the intervention as in the control group) is taken to the epu laboratory, he receives the first questionnaire in which the personal data and his mood / feeling of fear are collected. in addition, two questions on instrumental-qualification media studies should give an indication of possible relationships between the evaluation of video glasses. the patient is then led into the laboratory and connected to the monitoring by the team. before it is covered under sterile conditions, the patients in the intervention group receive the glasses and remote control with which they can select the footage from the media library. the anesthetist will inject a basic dose of sedative and analgesic (determined on the basis of body weight) into each patient and increase it if pain or agitation is noticeable. all patients receive their individual dosage to ensure painless ablation. during the examination, the vital parameters (blood pressure and heart rate) are documented at specified times. after completing catheter ablation, the video glasses (for patients from the intervention group) are removed. the patients receive a second questionnaire in which they evaluate the use of the video glasses. both the subjects in the intervention and control groups are asked to estimate the duration of the examination. the subjective sense of time is intended to provide information as to whether the patients in the intervention group experienced adequate distraction compared to the patients in the control group. follow-up: on the day after catheter ablation all patients receive the csq 8 questionnaire, which assesses patient satisfaction using categorical questions. a longer-term follow-up is not necessary.

Eligibility criteria:
inclusion criteria: * patient undergoing catheter ablation for rhythm disorders exclusion criteria: * epilepsy * age \<18 years * visus \ +2 dpt
does intense regimented surveillance improve the rates of therapeutic re-intervention after lung cancer surgery

Conditions: Lung Neoplasms

Summary: after curative lung cancer surgery, there is a risk of recurrence of the primary cancer, or development of a new cancer. historically, patients who have undergone curative lung cancer surgery have been monitored with chest radiographs (cxr). unfortunately, 70% of such patients still die of lung cancer. as a result, there has been interest in other methods of surveillance in order to detect recurring or new cancers earlier and have more success in treating them. one such technique is low dose computed tomography (ldct), which is currently the standard of care and surveillance at this institution. this pilot study aims to determine whether regimented, intensive, short interval ldct surveillance leads to higher rates of detection and treatment of recurring lung cancers. the study group will be followed up according to a regimented surveillance program using ldct. the study group will be compared to a group of historical controls whose follow up after surgery was not standardized, but rather left up to the discretion of the individual surgeon. if the results of this study show improvements in detection and treatment of recurrent cancers, it will allow for a larger trial to study the effects of the ldct surveillance program on lung cancer survival. the study question aims to determine whether for survivors after curative surgery for stage i and stage ii lung cancer, a structured surveillance program with low dose ct can increase the rate of detection and treatment of recurring or new cancers when compared to historical non-structured surveillance with cxr. this study will also determine if it is warranted to pursue a larger scale randomized controlled trial to further investigate optimal ldct surveillance follow-up intervals and long-term lung cancer survival.


Eligibility criteria:
inclusion criteria: * patients must be at minimum 18 years of age * patients must have undergone complete resection for pathological stage i or stage ii lung cancer * patients must demonstrate the ability to understand english * patients must be able to demonstrate aptitude and willingness to comply with describes study procedures exclusion criteria: * patients with residual gross or microscopic disease after surgery * patients with pathological stage iii or stage iv lung cancer

Keywords: retrospective review pilot study early stage nsclc post-surgical surveillance re-intervention rates
effects of tactile touch on chronic pain in parkinson´s disease

Conditions: Pain; Sleep

Summary: the parkitouch study compared the effects on pain, sleep quality and healthrelated quality of life (hrqol) among 44 participants with parkinson´s disease for at least two years and chronic pain.the two groups were randomized to either tactile touch and rest to music or only rest to music alone. it was prospective and had a duration of 34 weeks. the first 10 weeks was the intervention period , followed by a follow-up period. outcome measures were salivary cortisol concentration measured at seven occasions of which two were immediately before, after and 30 minutes after intervention. diurnal salivary cortisol was calculated based on four timepoints of sampling per 24 hour period.

this study was initiated by the massage therapists who had experienced pain reduction in parkinsonian patients when usin tactile touch. as the method consisted of a combination of music therapy and aroma therapy we chose just to study the effects of the tactile touch. hrqol was measured using sf-36 (swe.ver.1) sleep was measured with the pdss scale, pain wit vas 10 cm scale and the pain-o.meter. all measures were repeated during the study period. patients were not allowed to change their basic antiparkinson medication.all drugs were carefully registered and supervised by specialists in neurology at the three different study sites in southern sweden. the massage technique was described in a 11 a4 pages long description and the same method was used at all three sites. the same aroma oils, same temperature in the rooms and the same music was used.

Eligibility criteria:
inclusion criteria: * parkinson´s disease * chronic pain exclusion criteria: * epilepsy * active malignancy * diabetes mellitus * parkinson´s disease in complication phase

Keywords: parkinson´s disease pain sleep hpa axis function health related quality of life
the assessment of pocd after turbt under spinal anesthesia

Conditions: Bladder Tumor; Postoperative Cognitive Dysfunction

Summary: this study evaluates the influence of premedication on cognitive functions in patients undergoing transurethral resection of bladder tumor under spinal anesthesia. the aims of premedication are anxiolysis, analgesia and the reduction of perioperative risk among the patients with comorbidities. the patients will be randomly allocated to receive premedication either with opioid solely or with benzodiazepine combined with opioid. the anesthetic technique is standardized.

trans-urethral resection of bladder tumor (turbt) is the basic endoscopic procedure for management of bladder cancer and if there are no contraindications, it is performed under spinal anesthesia. the condition usually occurs among elderly patients, every 9 of 10 is older than 55 years. at this age the postoperative cognitive dysfunction (pocd) is a common complication as the risk increases with age. there are some studies indicating that using benzodiazepines during the perioperative period can also increase the number of registered pocd in patients undergoing anesthesia. postoperative cognitive dysfunction (pocd) occurs after operations under regional and general anesthesia as well. the study was planed to evaluate the risk of pocd among urological patients and to asses whether combining benzodiazepines with opioids for premedication increases this risk. the participants after giving the informed consent can participate in the study. the beck depression inventory is performed to rule out the patients with depression. the cognitive functions are tested with montreal cognitive assessment before the surgery and subsequently in the first 24 hours after surgery, three weeks later (while patients come back to receive histopathological examination), and finally six months after surgery (during control cystoscopy). during anesthesia, the patients will be randomly allocated to receive premedication either with opioid solely or with benzodiazepine combined with opioid. the anesthetic technique is standardized. if the premedication is needed before the surgery the hydroxyzine will be administrated.

Eligibility criteria:
inclusion criteria: * informed consent * transurethral resection of the bladder tumor * spinal anesthesia exclusion criteria: exclusion criteria: * patients' refusal * contraindications for spinal anesthesia * skin lesions at injection site * depression

Keywords: spinal anesthesia, turbt, pocd, premedication
a study on the efficacy of virtual reality exposure therapy (vret) for survivors of childhood sexual abuse and war related trauma

Conditions: Posttraumatic Stress Disorder (PTSD); Depression

Summary: background: childhood sexual abuse (csa) and combat related war-trauma are associated with posttraumatic stress disorder (ptsd) and depression. ptsd is one of the most prevalent diagnostic and statistical manual of mental disorders (dsm) axis 1 disorders for which psychotherapy is widely practiced. depression is one of the most common co morbid disorders when ptsd is diagnosed. exposure to the traumatic memories or cues of the traumatic event often plays an important role in reducing symptoms of ptsd. also symptoms of ptsd and depression have been related to a reduced specificity in autobiographical memory. objective: this study will examine the efficacy of a virtual reality exposure therapy (vret) in a csa and war related trauma sample by comparing it with treatment as usual (tau). it will also attempt to develop protocols to implement this new technology into clinical practice and collect data to develop a treatment progress prediction model. study design: a randomized controlled intervention study. study population: 144 individuals with memories of csa or war related trauma and symptoms of ptsd and/or depression. intervention: vret or tau.


Eligibility criteria:
inclusion criteria: * principal diagnosis meeting dsm-iv criteria for ptsd and/or major depression following csa or war related trauma * between the ages of 18 and 70-years-old * having sufficient fluency in dutch to complete treatment and research protocol exclusion criteria: * current bipolar disorder * current psychotic disorders * current suicidality * high dissociation level (dissociative experiences scale (des) cut-off score ≥ 40)

Keywords: posttraumatic stress disorder depression treatment vret
cognitive flexibility in major depression in the course of pharmacological and psychotherapeutic treatment

Conditions: Cognitive Performance in Major Depression

Summary: cognitive deficits in major depression seem explicable by the well-recognized concept of impaired neuroplasticity in mood disorders. this concept initially emerged from preclinical evidence that antidepressants phosphorylate and therefore activate the cyclic amp response element binding protein (creb) that is essential for synaptic plasticity. nevertheless, the question remains whether the activation of creb by antidepressants is relevant for the remission of cognitive deficits in patients. we addressed this issue by investigating the cognitive improvement during treatment with either citalopram or reboxetine because these antidepressants are different in their capacity to increase phosphorylated creb (pcreb). besides the pharmacological treatment groups, another group of patients was treated exclusively with psychotherapy.

we randomly assigned forty-five depressive patients to one of three treatment groups (citalopram, reboxetin or interpersonal psychotherapy (ipt)). at baseline, day 7 and day 28 we assessed the severity of depression and the cognitive performance with respect to cognitive flexibility, memory and attention. we measured pcreb with an enzyme linked immuno sorbent assay (elisa).

Eligibility criteria:
inclusion criteria: * diagnosed according dsm-iv criteria as suffering from major depressive disorder * a baseline score of at least 18 in the hamilton depression scale (hamd) * no psychopharmacological treatment at least one week prior inclusion or 3 days wash-out exclusion criteria: * severe depressive episode and/or psychotic depressive episode axis i disorder: * substance-related disorders * psychotic disorders * dementia or other cognitive disorders * obsessive-compulsive disorders axis ii disorder: • borderline personality disorder axis iii disorder: * infectious diseases * cancer * endocrinological diseases * hematological diseases * autoimmune diseases

Keywords: depression creb cognitive performance psychotherapy ssri snri
open-label extension for phase 3 clinical trials of simufilam

Conditions: Alzheimer Disease

Summary: the goal of this open-label extension study is to assess long-term safety and tolerability of simufilam 100 mg in subjects who have completed the rethink-alz or refocus-alz phase 3 clinical trials.

this is a multi-national, multi-center, fixed-dose, 52-week, open-label extension study. after completing participation in either rethink-alz (pti-125-06) or refocus-alz (pti-125-07), subjects will have the option to participate in this study. after the subject provides consent and the investigator confirms the subject satisfies both inclusion and exclusion criteria, the study drug will be administered at the research site on study day 1 and subsequent visits will be scheduled. we anticipate up to 1600 subjects may enroll in this study. approximately up to 150 clinical sites in the usa, canada, south korea, and australia will have the option to participate in this collaborative research effort. for subjects electing to participate, the clinical and laboratory assessments from the week 76 (refocus-alz) or week 52 (rethink-alz) end-of-treatment visit will serve as baseline visit assessments for the open-label study on study day 1. all subjects will return in 4 weeks and every 12 weeks thereafter for safety assessments. at all post-baseline visits, subjects will report any adverse events since their last visit. in addition to adverse event monitoring, safety will be evaluated at every visit by vital signs, brief examinations, clinical laboratory tests (biochemistry, hematology, and urinalysis) and the columbia suicide severity rating scale (c-ssrs). study drug use since the last visit will be assessed and a new bottle of study drug will be dispensed. the emerging subject safety assessments will be monitored throughout the study by an independent data safety monitoring board (dsmb).

Eligibility criteria:
inclusion criterion: * completed rethink-alz (pti-125-07) or refocus-alz (pti-125-06). * clinical presentation continues to be consistent with alzheimer's disease. * availability of a study partner. exclusion criteria: * residence in a skilled nursing facility requiring 24-hour care. * evidence of a neurologic condition other than ad that significantly contributes to the subject's dementia. * current clinically significant psychiatric diagnosis other than ad. * unstable, clinically significant medical condition other than ad. * any medical condition that in the opinion of the investigator may affect safety or ability to complete the study.