Kornimate/medical-research-clean huggingface dataset:
duo partnership adherence commitment therapy

Conditions: HIV/AIDS

Summary: this is a randomized controlled trial of a new behavioral intervention designed to improve engagement in hiv care for couples. investigators will compare the hiv viral load outcomes of couples randomized to a couples-based adherence intervention (duopact) or to an individual adherence intervention (lifesteps).

the investigators will test the intervention to improve hiv care engagement by enrolling 150 sexual or gender minority couples and randomizing 75 couples each to one of two conditions: 1) duopact, a newly-developed couples intervention; or 2) lifesteps, a standardized antiretroviral adherence intervention for hiv+ individuals. after randomization, intervention sessions will be delivered weekly (6 duopact sessions, or 3 life steps sessions). all couples will be assessed pre/post intervention to evaluate intervention effects via behavioral indicators of engagement in hiv care, the couple's relationship dynamics, and the primary outcome of hiv viral load.

Eligibility criteria:
inclusion criteria: 1. 18+ years old; 2. identifies as a sexual or gender minority; 3. in a primary romantic relationship for at least 3 months; 4. at least one partner is hiv+; 5. english-speaking; 6. able to provide informed consent; and 7. for hiv+ participants: evidence of suboptimal engagement in hiv care. exclusion criteria: 1. must be able to consent to and follow study protocol; 2. evidence of severe cognitive impairment or active psychosis; 3. lives outside california or plans to relocate from the state of california in the next 6 months; or 4. participation in the duopact pilot.

Keywords: treatment adherence intervention sexual and gender minority couples
stop persistent af pas

Conditions: Persistent Atrial Fibrillation

Summary: the stop persistent af post approval study (pas) is a prospective, global, multicenter, observational trial.

the stop persistent af post approval study (pas) is a sub-study to the cryo global registry. the pas is a prospective, global, multicenter, observational trial. the purpose of the pas is to describe long-term clinical performance and safety data in the persistent af population treated with arctic front™ and freezor™ max families of cardiac cryoablation catheters (hereafter referred to as arctic front™ cardiac cryoablation catheter system). this pas is a condition of the pre-market approval order (p100010/s098) by the u.s. food and drug administration. up to 400 subjects will be enrolled to ensure 355 are treated. a minimum of 50% of patients will be enrolled and treated in the us. the follow-up duration for this post-approval study will be 36-months.

Eligibility criteria:
inclusion criteria: * subject has been diagnosed with persistent af. * subject is ≥ 18 years of age or minimum age as required by local regulations. * planned pulmonary vein isolation (pvi) procedure using commercially available arctic front™ cardiac cryoablation catheter system. * willing to comply with study requirements and give informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements. exclusion criteria: * subject has had a prior atrial ablation (except for cavo-tricuspid isthmus (cti) ablation for afl). * subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager. * subject with exclusion criteria required by local law.
cognitive training cerebral palsy

Conditions: Cerebral Palsy

Summary: this study aims to conduct a single-blind randomized controlled trial with sixty children with cerebral palsy (cp) to explore if a home-based computerized multi-modal executive training is effective improving infants' executive functions (ef), as the primary outcome. as secondary outcomes, it will be tested if the intervention exerts a positive effect on other cognitive functions, social relationships, and quality of life (qol) in children with cp. it is expected to observe changes in brain structure and functioning associated to clinical improvements. the primary hypothesis to be tested is that a computerized multi-modal cognitive training will be more effective at improving ef than usual care alone. secondary hypotheses are that the computerized therapy will be more effective than usual care alone at improving specific cognitive functions such as visuoperception, memory, social relationships and qol. in addition, we also hypothesize there will be changes on brain structure and function. we further hypothesise that these changes will be maintained over time (9 months). finally, sociodemographic and clinical factors are expected to be related with the level of efficacy of the computerized multi-modal cognitive training.


Eligibility criteria:
inclusion criteria: * aged 8-12 years. * manual abilities classification scale (macs) ranging from i to iii. * an intelligible yes/no response system. * being able to understand simple instructions. * having the possibility of participating in the investigation for one year. * being able to access to internet at home. exclusion criteria: * identified hearing or visual impairment that precludes neuropsychological assessment and training.

Keywords: cerebral palsy executive functions cognitive training computerized therapy quality of life neuroimaging participation
the morphology of the peri-implantitis defects: a cone-beam computed analysis

Conditions: Peri-Implantitis

Summary: to study the morphology of the peri-implant defects using cone-beam computed tomography based on a priori case definition of peri-implantitis (≥3mm of radiographic bone loss + inflammatory clinical parameters) diagnosis of peri-implantitis requires: * presence of bleeding and/or suppuration on gentle probing. * increased probing depth compared to previous examinations. * presence of bone loss beyond crestal bone level changes resulting from initial bone remodeling. in the absence of previous examination data diagnosis of peri-implantitis can be based on the combination of: * presence of bleeding and/or suppuration on gentle probing. * probing depths of ≥6 mm. * bone levels ≥3 mm apical of the most coronal portion of the intraosseous part of the implant.

nowadays, several radiographic techniques are available to investigate the peri-implant bone morphology by two-dimensional radiographs such as panoramic radiography and intraoral radiography, or three-dimensional techniques such as computer tomography and cone beam computer tomography (cbct) (harris et al. 2012). cbct provides high-contrast 3d visualization of bone beds; however, artifacts caused by the metallic character of implants could disguise information around implants. the diagnostic outcomes of cbct imaging of peri-implant bone loss have been related to the type of study and defect morphology (pelekos et al., 2018). the ex vivo studies (cadaver models), considering sensitivity and specificity reported good values for both circumferential and infrabony defects but lower for dehiscences (de-azevedo-vaz et al., 2013, kamburoglu et al., 2013). contrastingly, cbct imaging for defect analysis in animal studies showed positive correlation with histology but tend to overestimate (fienitz et al., 2012, golubovic et al., 2012) or underestimate (corpas ldos et al., 2011, ritter et al., 2014) the size of the defect. this variability in the measurement is mainly dependent on the different configuration, location or size of the defect. and also by the scattering, beam hardening artifacts, energy settings, exposure time, field of view. hence, it is aimed at assessing the morphology of the peri-implant defects using cbct

Eligibility criteria:
inclusion criteria: * male or female patients between 18 and 80 years of age * partial/complete edentulism missing one or more teeth and having it restored with implant-supported prosthesis * no antibiotic in the last 2 months previous to examination * \>3 year after prosthesis delivery exclusion criteria: * uncontrolled systemic disease * cemented-retained restorations * patients with uncontrolled/active periodontal disease in need of periodontal treatment * pregnant patients * zygomatic implants * implants placed in regenerated/augmented bone * patients taking medications known to modify bone metabolism or known to have degenerative diseases of bone (hyperparathyroidism, osteoporosis), vitamin d, patients who had taken antibiotics, nsaids or corticosteroids for more than two weeks in the past 3 months before examination
the criteria for lymph node sorting for pathological examination in gastric cancer

Conditions: Lymph Node Metastases; Gastric Cancer; Exanimation

Summary: the aim of this study is intending to provide the optimal procedures of lymph node sorting for pathological examination after curative surgery for gastric cancer, which can discriminate the differences of the status of lymph node metastasis, ptnm classification and prognostic outcome of gastric cancer patients.


Eligibility criteria:
inclusion criteria: * 1) physical conditions compliance with the requirements for curative gastrectomy * 2) consent to undergo the d2 lymphadenectomy * 3) comply with the protocol during the whole study period * 4) no neoadjuvant therapy administration * 5) sign informed consent and permission of withdraw in the whole study period * 6) consent to provide the tissue specimens after surgery for this study * 7) pathological examination confirmation the adenocarcinoma of stomach before surgery * 8) estimation the overall survival after surgery no less than 6 months * 9) no anesthesia or operation contraindication disease * 10) ctanynanym0 stage demonstration by ct and endoscopic ultrasonography examinations * 11) negative cytological detection in operation * 12) no seriously concomitance's diseases * 13) karnofsky performance scores (kps) more than 60 exclusion criteria: * 1) women during pregnant stage and breast-feed stage * 2) women of childbearing age without any contraceptive measures * 3) severe congestive heart failure, frequent arrhythmia, or myocardial infarction within 12 months * 4) immunosuppressive therapists for organ transplantation * 5) seriously uncontrolled recurrent infection * 6) other malignant tumors * 7) no abilities of self-knowledge or mental disorders * 8) participating in other clinical trials * 9) siewert i and ii esophagogastric junction tumors * 10) serious internal diseases obstruction surgery
prediction of progression of age-related macular degeneration

Conditions: Macular Degeneration; Macular Degeneration, Wet; Macular Degeneration, Dry

Summary: the goal for this study is to initiate a randomized, controlled clinical trial to test the viability of personalized amd progression prediction models. early and intermediate amd patients will be recruited and randomly assigned them to a control or test group. the test group will include patients who will receive personalized follow-up care based on their predicted risk, and collect baseline and follow-up data. this work will advance the amd field by improving the identification of high-risk patients as candidates for more frequent screening and earlier treatment, leading to better clinical outcomes.

more than 90% of patients with advanced amd have severe vision loss. predicting amd progression from an early or intermediate stage is crucial, since prompt intervention after a choroidal neovascularization (cnv) event and geographic atrophy (ga) monitoring can greatly improve visual outcomes. patients at higher risk of progression should have more frequent follow-up visits, since progression often occurs before any visual changes are noticed by the patient. previous work has determined the risk factors for amd progression based on drusen features in fundus photos, optical coherence tomography (oct) and from genetic factors. however, current models are limited by their ability to make predictions over short intervals, which limits their utility in guiding screening intervals. in this study we will recruit patients with early and intermediate amd in at least one eye who are at risk of converting to wet amd or ga expansion. we will perform a randomized trial where we will randomly assign them to a control or test group (personalized follow-up care starting at 3 months based on their predicted risk from algorithm results), and collect baseline genetic, demographic, imaging, and clinical data and first follow-up data at the 3 month and 6 month follow-up time points. outcomes will be measured to determine if an algorithm predicting early follow-up for high-risk patients (3 month) is advantageous over the standard 6 month follow-up time point.

Eligibility criteria:
inclusion criteria: * non-neovascular amd at baseline in at least one eye with no signs of ga, * \> 45 years of age, * willingness to participate through a signed consent form. exclusion criteria: * pregnant women and vulnerable populations * participation in an investigational trial that involves treatment with any drug (with the exception of vitamins or minerals) within 3 months prior to day 1. * any history of macular pathology unrelated to amd affecting vision or contributing to the presence of intraretinal or subretinal fluid
determine long-term safety and tolerability of pregabalin in patients with anxiety disorders.

Conditions: Anxiety Neuroses

Summary: determine long-term safety and tolerability of pregabalin in patients with anxiety disorders.


Eligibility criteria:
inclusion criteria: * must have completed the double-blind portion of the preceding trial * completed any protocol specified withdrawal phase and follow-up visits. exclusion criteria: * patient cannot participate if they experienced a serious adverse event or a nonserious, but medically significant adverse event during the preceding efficacy study that was judged to be related to the study medication.
mandibular single implant overdenture: a prospective clinical trial

Conditions: Edentulous

Summary: study hypothesis: that there would be no difference in patient satisfaction among institutionalised older people before and after treatment with a mandibular single implant-retained overdenture. in a preliminary phase, a new denture is made or the old denture is adapted to provide a well-fitting denture. eight weeks after insertion of the new denture a single implant is placed in the centre of the mandibula. if the level of primary stability is sufficient to enable the implant to resist micromovement, the implant is immediately loaded . if not, the implant is loaded after 6 to 12 weeks. primary stability is assessed by the final seating torque and by the clinician's interpretation and tactile sense of primary stability. before, during and after the treatment patient satisfaction and clinical outcomes are evaluated by a 20 item questionnaire and a clinical examination.


Eligibility criteria:
inclusion criteria: * edentulous residents of nursing homes treated in the mobile dental unit 'gerodent'. * they have to be willing to commit to 1.5 year of participation in the study. * they have to be edentulous for at least one year before starting the implant procedure. exclusion criteria: * medical conditions contraindicating implant surgery (unregulated diabetes type ii, bisphosphonates) * history of radiotherapy in the head and neck region * insufficient bone for an implant of at least 10 mm length and 4 mm diameter * previously treated with dental implants

Keywords: single implant denture elderly with an unstable mandibular denture
optimal sensing in atrial tachyarrhythmia's study

Conditions: Sick Sinus Syndrome; Paroxysmal Atrial Fibrillation

Summary: the aim of the study is the comparison of two different leads in their capabilities to detect episodes and duration of paroxysmal atrial fibrillation (af) and atrial tachyarrhythmia (at), and the rejection of far field sensing of the far field r-wave (ffrw).

the aim of the study is the comparison of two different leads in their capabilities to detect episodes and duration of paroxysmal af and at and the rejection of far field sensing of the far field r-wave (ffrw). the study aims to evaluate the accuracy of the detection of atrial tachyarrhythmias (atas). an improved detection can potentially increase the accuracy of clinical treatment decisions, based on device derived data.

Eligibility criteria:
inclusion criteria: * patients with class i or ii pacing indications for sick sinus syndrome with suspected paroxysmal atrial tachyarrhythmias over the last 6 months * signed informed consent * age \>18 yrs exclusion criteria: * severe valvular heart disease (echocardiogram less than 6 months old) * angina pectoris class ≥ iii * congestive heart failure - nyha class ≥ iii * left ventricular ejection fraction \< 35% (less than 6 months old) * hypertrophic cardiomyopathy

Keywords: af automatic mode switch ffrw paroxysmal af
combination chemotherapy plus panitumumab or bevacizumab for inoperable cholangiocarcinoma without kras mutations

Conditions: Cholangiocarcinoma

Summary: the purpose of this study is to determine the rate of progression free survival of patients with inoperable cholangiocarcinoma 6 months after enrollment in the study. the patients are treated with combination chemotherapy supplemented by biological agents panitumumab or bevacizumab.


Eligibility criteria:
inclusion criteria: * histologically verified adenocarcinoma arisen from gall bladder, extra- or intrahepatic bile ducts or malignant cells consistent with the above and simultaneous radiologic findings consistent with cholangiocarcinoma * minimum 18 years of age * curative treatment currently not an option (operation, stereotactic radiation treatment or similar) * kras analyzed and found wild-type (wt) * performance status 0-2 * evaluable disease according to recist, i.e. the disease need not be measurable * hematology: anc ≥1.5x10\^9/l. thrombocytes ≥ 100x10\^9/l * biochemistry: bilirubinemia ≤ 3 x upper normal level. alat ≤ 5 x upper normal level. * creatinine ≤ upper normal level. at raised creatinine level the measured or calculated gfr must be at least 50% of the lower normal level * fertile women must present a negative pregnancy test and use secure birth control during and 6 months after treatment. men with fertile partners must also take care of secure birth control. * written and orally informed consent exclusion criteria: * previous cytostatic treatment of inoperable cholangiocarcinoma * adjuvant or neoadjuvant chemotherapy, radiation therapy or immunotherapy within 4 weeks prior to treatment start * other concomitant experimental treatment * severe medical disease such as considerable heart disease, serious active infection or other disease making the patient unfit for study participation as assessed by investigator * other malignant disease within 5 years prior to enrolment except from non-melanotic skin cancer and carcinoma in situ cervicis uteri * interstitial pneumonitis or subsequent pulmonary fibrosis * pregnant or breastfeeding women * large-scale surgical intervention, excision biopsy or significant traumatic lesions within 28 days prior to treatment start or presumption that large-scale surgery will become necessary during study treatment. * significant non-healing wound or ulcers * active hemorrhage or increased risk of hemorrhage (e.g. tumor invasion in large vessels or known esophagus varices) * known hypersensitivity to panitumumab, bevacizumab or any of the auxiliary agents * grade iv fistulas * uncontrolled hypertension, i.e. symptomatic hypertension or non-medically stabilized hypertension \>160/100 * haemoptysis \> 2.5 ml within 2 weeks prior to enrolment * previous serious and unexpected reactions or know hypersensitivity to two or more of the applied cytostatics

Keywords: cholangiocarcinoma inoperable kras mutation biological treatment combination chemotherapy monoclonal antibody
effects of breathing training on psychosocial functioning and heart rate variability in postmenopausal women with depressive symptoms-2

Conditions: Postmenopause

Summary: the specific aims of this study are: 1. to develop a breathing training protocol specifically designed to improve hrv and psychosocial functioning for postmenopausal women with depressive symptoms, 2. to examine the immediate effects of an 8-week breathing training program on hrv and psychosocial end points in postmenopausal women with depressive symptoms, 3. to examine the intermediate-term effects of an 8-week breathing training program on hrv and psychosocial end points in postmenopausal women with depressive symptoms, and 4. to determine whether the change in depressive symptoms with breathing training in postmenopausal women is associated with the change in hrv.

postmenopausal women without hormone replacement therapy are associated with higher risk of cardiac morbidity and mortality. they are likely to experience depressive symptoms after menopause, and the comorbidity of depression are related to altered autonomic function. we expect that postmenopausal women with depressive symptoms who receive breathing training will demonstrate decreased depressive symptoms and increased heart rate variability immediately upon and later after completion of training, and optimally contributing to improve autonomic nervous regulation in their later life to prevent undesired cardiac outcomes.

Eligibility criteria:
inclusion criteria: * permanent termination of menstruation of natural cause. * cessation of menstrual cycles for more than 12 consecutive months. * a score of the chinese version of beck depression inventory-ii of greater than 10. * able to speak mandarin or taiwanese. * age from 45 to 64 years. exclusion criteria: * subjects who are clinically diagnosed with history of cardiac arrhythmia, coronary heart disease, heart failure, kidney disease, hypertension, chronic low blood pressure, diabetic neuropathy, psychosis, mental deficiency. * subjects who received hormone replacement therapy prescribed by gynecological physicians. * subjects who took cardiac and/or psychotropic medications which may affect the autonomic functions

Keywords: depression depressive symptoms postmenopause rsa biofeedback