Kornimate/medical-research-clean huggingface dataset:
bpa vs. pea in cteph

Conditions: Chronic Thromboembolic Pulmonary Hypertension

Summary: chronic thromboembolic pulmonary hypertension (cteph) is a rare and potentially life-threatening progressive disease that evolves from unresolved pulmonary embolism. gold standard treatment for cteph is pulmonary endarterectomy (pea) performed by skilled cardio-thoracic surgeons. some patients may not be surgical candidates due to co-morbidities or because the vascular lesions are too distal making them technically inoperable. in these patients, balloon pulmonary angioplasty (bpa) has emerged as an effective treatment. in a subgroup of patients, the distribution of vascular lesions makes it possible to perform either bpa or pea. there has never been a head-to head comparison of bpa with pea. the aim of this study is therefore, to evaluate if bpa is non-inferior to pea in patients with (cteph) who are eligible for both treatments.

an investigator-initiated multicenter, prospective, randomized, controlled, open label, non-inferiority trial. the study will randomize (1:1) 152 patients with cteph who are eligible for both pea and bpa. patients will be screened for study inclusion at the local cteph multidisciplinary team conference and eligibility for both pea and bpa will be confirmed by a central adjudication committee. pea or bpa will be completed within 6 months from randomization. follow-up visit with right heart catheterization will be completed at 4 months and 12 months after pea or last bpa session. primary end-point is change in pulmonary vascular resistance from baseline to 4 months and 12 months after pea or the last bpa session.

Eligibility criteria:
inclusion criteria: * diagnosed with chronic thromboembolic pulmonary hypertension according to current european society of cardiology/european respiratory society guidelines and eligible for both pulmonary endarterectomy and ballon pulmonary angioplasty by decision at the local multidisciplinary team conference and central adjudication committee * written informed consent from the patient * patient age \>17 and \<80 years * able to understand and follow instructions and to participate in the entire study period exclusion criteria: * life expectancy \<12 months * co morbidities evaluated at the multidisciplinary team conference, that contributes significantly to the patients pulmonary hypertension * not possible to perform balloon pulmonary angioplasty or pulmonary endarterectomy within 4 months after randomization. * evaluated at multidisciplinary team conference that changes in pulmonary artery hypertension targeted therapy between baseline and 4 months follow-up is inevitable\* * known pregnancy or positive urine human chorionic gonadotropin screening test in fertile women * previous balloon pulmonary angioplasty or pulmonary endarterectomy
one month degarelix/comparator treatment for prostate cancer in chinese population

Conditions: Prostate Cancer

Summary: one month degarelix/comparator treatment for prostate cancer in chinese population


Eligibility criteria:
inclusion criteria: * chinese male over 18 years * adenocarcinoma of the prostate * relevant disease status based on lab values and as judged by the physician * life expectancy of at least a year exclusion criteria: * previous hormonal treatment for prostate cancer * considered to be candidate for curative therapy * risk or history of any serious or significant health condition * has received an investigational drug within the last 28 days and no previous treatment with degarelix
outcomes, patient health status, and efficiency in chronic total occlusion

Conditions: Coronary Artery Disease

Summary: this is an observational registry, sponsored by saint luke's hospital. this study is to be conducted according to dhhs guidelines, applicable state regulations, and local irb policies and procedures. the overall objective is to address current gaps in knowledge regarding cto-pci, as a prospective, multi-center, single-arm study of 1,000 participants.

* 1,000 participants will be enrolled into the open cto study. * study coordinators will screen both men and women over the age of 18 who are admitted for an elective cto-pci procedure. * study coordinators will be trained by the coordinating center at saint luke's hospital of kansas city. * participants will be screened for eligibility, and informed consent will be obtained. * participants will also be asked to sign a medical records release form, and a billing records release form. * detailed procedural data will be obtained by the study coordinator and local principal investigator. * participants will undergo a baseline interview. * these data will be entered into the electronic data capture system, velos, which has stringent protections and quality controls. * participants will have telephone follow-up interviews conducted by the centralized follow-up center at saint luke's hospital.

Eligibility criteria:
inclusion criteria: * subject is scheduled for a pci procedure for at least one chronic total occlusion with timi antegrade flow of zero. * subject is ≥ 18 years of age at the time of consent. exclusion criteria: * the cto segment is in a graft * female subjects with a positive quantitative or qualitative pregnancy test, in accordance with hospital policy. * non-english speaking * too hard of hearing to do follow-up by telephone. * previously enrolled in open cto registry * currently a prisoner * dementia * subjects with no way contact by telephone for follow-up.

Keywords: coronary artery disease chronic total occlusion
safety and tolerability of a novel implantable device for the treatment of erectile dysfunction

Conditions: Erectile Dysfunction Following Radical Prostatectomy

Summary: the goal of this clinical trial is to assess if a new device is safe to use as a potential treatment for erectile dysfunction following radical prostatectomy. the main questions it aims to answer are: * is the device safe? * does the device works well? are the participants satisfied with the device? participants will be implanted with the device during the ongoing prostatectomy surgery and will be asked to complete the following tasks during 6 months follow-up: * come to the hospital for follow-up visits, * complete questionnaires, * activate the device every day, * measure erection hardness. researchers will compare an implanted group (participants having the device) with a control group (participants not having the device) to see if the device works well.


Eligibility criteria:
inclusion criteria: * men of ages between 30-70 years; * men with indication for nerve-sparing prostatectomy surgery; * localised prostate cancer considered suitable for bilateral nerve sparing prostatectomy according to clinical criteria * international index of erectile function (iief-15) erectile function domain score equal to or greater than 26 prior prostatectomy; * men interested in minimizing the effect of radical prostatectomy on erectile function; * ability to read and understand patient information materials and willingness to sign a written informed consent. exclusion criteria: * men with neurological disease, including a history of spinal cord injury or trauma; * iief-15 erectile function domain score less than 26 prior prostatectomy; * failure to demonstrate adequate nocturnal erectile function prior prostatectomy; * history of erectile dysfunction, priapism and peyronie disease; * history of previous pelvic surgery, trauma or irradiation therapy; * currently have an active implantable device; * patient diagnosed with neurologic degenerative diseases that may negatively impact erectile functions; * identification of technical or clinical limitation to properly apply the use of nerve-sparing techniques during operation; * inability to understand and demonstrate device use instructions; * patients with insulin-dependent diabetes who suffer peripheral neuropathy or other diabetes associated complications; * patient unwillingness to engage in sexual activity; * patient is currently participating in another clinical investigation that would serve as a contraindication to implant a neurostimulator device to augment erectile function; * have participated in any drug or device trial in the last 4 weeks or plan to participate in any other drug or device study during the next 24 months; * possess any other characteristics that, per the investigator's judgment, may increase the risk or impair data collection for the procedure/study; * patient is a member of a vulnerable population (vulnerable participants include those who lack consent capacity, including the mentally ill, prisoners, cognitively impaired participants, and employee volunteers).
behavioral support techniques on anxiety and physical reaction from dental treatment

Conditions: Dental Anxiety; Dental Diseases; Dental Trauma

Summary: application of deep touch pressure (dtp) has been suggested to provide positive effects on anxiety modulation. however, empirical and theoretical evidence linked to the clinical effects of dtp is relatively rare in the behavioral and physiological aspects. the aim of this intervention trial study designs to investigate the effect of dtp in dental treatment by quantitative analysis of behavioral assessments and physiological measurements, including the electrodermal activity and heart rate variability, were conducted to understand the modulation of the autonomic nervous system (ans), the orchestration of sympathetic (sns) and parasympathetic (psns) nervous systems.

the subjects were recruited through word-of-mouth and by posted sign-up from the department of dentistry, national taiwan university hospital (ntuh), taiwan. informed consent was obtained prior to participation. the study protocol was approved by the human research ethics committee of ntuh. before the testing, the experimental protocol was explained to the subjects. the subjects with normal overnight sleep quality were recruited to prevent the influences in both physiological and physical fatigue. all potential subjects receive independent examinations by an occupational therapist and a dentist to determine the eligibility for inclusion as well as were blind to the study hypotheses. both electrodermal activity (eda) and heart rate variability (hrv) were recorded continually through the entire testing procedures. since the eda and hrv are sensitive indicators for autonomic nervous system modulation, a standardization procedure that ensures the integrity of data is accessed. the power of the testing is preset at 0.80, and the significant level is 0.05. the quasi-experimental design of clinical trial for repeated measures will be used.

Eligibility criteria:
inclusion criteria: * patients who requiring tooth extraction were potentially selected to recruit. exclusion criteria: * with a history of systemic diseases that would contraindicate surgical treatment * pregnant and lactating * smoking of more than 10 cigarettes per day * poor overnight sleep quality * refusal to sign the inform consent agreement
to evaluate the effectiveness(immunogeneicity) and safety of 'gc1107' administered intramuscularly in healthy adults

Conditions: Bacterial Infections

Summary: the purpose of this study is to evaluate the effectiveness(immunogeneicity) and safety of 'gc1107' administered intramuscularly in healthy adults.

randomized, double blind, multicenter, phaseⅲ study

Eligibility criteria:
inclusion criteria: * healthy korean adults (age: over 18 years) * who got the basic vaccination of dtp(diphtheria, tetanus, pertussis) in the past * subjects willing to provide written informed consent and able to comply with the requirements for the study exclusion criteria: * subjects who have already got the additional vaccination of td within 5 years * subjects with antitoxin of diphtheria and tetanus ≥1.0 iu/ml (elisa) * only applicable in step i * subjects who have not recovered from the acute disease within 2 weeks * subjects who have the medical history of allergic disease related to the components of investigational drug * who got the treatment of blood product and immunoglobulin product within 3 months * females who are pregnant * females who are breastfeeding * subjects who are infected from the diphtheria and tetanus * subjects who have experienced the severe adverse events for the diphtheria and tetanus vaccination * subjects who are scheduled to participate in other clinical trial studies during the study * subjects who have participated in any other clinical trials within 4 weeks of the administration of the study * those who take the other medicine that affects this study or are vaccinated other vaccines * subject who have received adrenocortical hormones or immunosuppressive drug within 4weeks of enrollment * subjects with a history of chronic disease obstacles to the study. * subjects who have episode of acute febrile (at least 37.4) after injection of vaccine during the study * subject who have plan of operation during the study. * individuals with other clinically significant medical or psychological condition who are considered by the investigator to be ineligible for the study.
cognitive training for nicotine dependence

Conditions: Tobacco Use Disorder; Nicotine Addiction

Summary: this randomized clinical trial tested the effects of a computerized (web-based) cognitive training intervention on smoking cessation. all participants received 8 weeks of standard nicotine patch therapy, smoking cessation counseling, and were randomized to 1 of 2 different training programs: cognitive training vs. control training.


Eligibility criteria:
inclusion: 1. healthy male and female treatment-seeking smokers who are between 18 and 65 years of age and self-report smoking at least 5 cigarettes (menthol and/or non-menthol) per day for at least the last 6 months 2. plan to live in the area for at least the next 8 months 3. capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and hipaa form 4. able to communicate fluently in english (speaking, writing, and reading) 5. have uninterrupted access to a home computer with sound capabilities, keyboard, mouse, and active internet connection 6. provide a carbon monoxide (co) breath test reading greater than or equal to 8 parts per million (ppm) at intake visit

Keywords: tobacco smoking cognition behavioral training relapse
motivational interviewing to enhance behavioral change in older adults with hoarding disorder

Conditions: Hoarding Disorder

Summary: this study will compare two behavioral interventions for hoarding disorder in older adults.

hoarding disorder is a psychological condition with a unique constellation of consequences for older adults, including increased risk of fire and dying in a fire, insect infestation, and medical problems. dangers related to cluttered living spaces are exacerbated by reduced executive functioning, attention, and concentration. hoarding psychopathology results from maladaptive cognitions (e.g., desire to keep items others would discard) and maladaptive behavioral patterns (e.g., avoidance of sorting/discarding items). extant treatments for hoarding have targeted fear reduction as the mechanism of change, either through cognitive-behavioral therapy focusing on cognitive restructuring or behavior therapy focusing on exposure therapy. older adults have a lackluster response to cognitive restructuring for hoarding, and, although exposure therapy increases treatment response, both approaches require a lengthy six-month dose. our preliminary work suggests that fear reduction may not be a universally relevant target mechanism for older adults, and that to be responsive to the specific needs of older adults, other mechanisms need to be identified. motivational interviewing is a technique that is already typically incorporated into hoarding treatment and has been demonstrated to increase motivation for behavioral change across a range of health conditions for older adults, including physical activity, diet, and disease management. because sorting/discarding is at its core a health behavior that hoarding patients lack the motivation to engage in, motivational interviewing is likely to decrease hoarding severity by eliciting increased levels of sorting/discarding. the proposed project will use a mechanistic clinical trials approach to determine if a four-month intervention combining motivational interviewing with sorting practice can engage the proposed target, motivation for behavioral change, when compared to a four-month dose of sorting practice alone in a sample of rural-dwelling older adults with hoarding disorder.

Eligibility criteria:
inclusion criteria: * aged 60+ * live within a 60-minute driving radius of starkville, ms * have a primary psychiatric diagnosis of hoarding disorder exclusion criteria: * major cognitive impairment * active psychosis, drug use, or acute suicidal ideation * concurrent psychotherapy focused on hoarding * changed psychotropic medications within the past three months
autonomic cardiovascular control after heart transplantation

Conditions: Heart Transplant Recipients

Summary: the purpose of this prospective study is to investigate denervation (ie. surgical cutting of autonomic nerves) and re-innervation (ie. growth of autonomic nerves) in heart transplant recipients. more specifically, we focus on: 1. the physiological consequences of denervation, in particular its consequences for clinical symptoms, orthostatic tolerance (ie. the ability to stand upright) and exercise capacity. we hypothesize that denervation has negative consequences for all these factors. 2. the pathological consequences of denervation and reinnervation, in particular its association to acute rejection and coronary artery disease (cardiac allograft vasculopathy, cav). we hypothesize that reinnervation protects against acute rejection and development of cav 3. donor and recipient factors associated with the reinnervation process. we hypothesize that characteristics of the surgical procedure (such as aorta cross-clamp time) as well as the rehabilitation process of the recipient (such as physical activity) impacts on the reinnervation process.

heart transplantation is annually offered to more than 3500 patients worldwide. in norway, the number is approximately 30/year, and all transplants are carried out at one single hospital (oslo university hospital, rikshospitalet). normally, the heart function is intimately controlled by the autonomic nervous system (ans), but all nervous connections are lost during the surgical transplantation procedure, and the transplanted heart thus becomes denervated. in time, regrowth of nerves may cause partial reinnervation of the new heart. some evidence suggests that reinnervation improves exercise capacity and reduces episodes of acute rejections and the development of cardiac allograft vasculopathy. the purpose of this study is further to investigate the changes over time with respect to all parts of the autonomic nervous system (the sympathetic, parasympathetic and sensoric part), and the associated physiological and pathological consequences. the study may provide knowledge which ultimately could help us improve health and quality of live for heart transplant recipients.

Eligibility criteria:
inclusion criteria htrs: * completed heart transplantation during the last 7-12 weeks * age \> 16 years and \< 70 years exclusion criteria htrs: * peri- or postoperative complications causing permanent dysfunction of the allograft (such as hyperacute rejection episodes, severe myocardial ischemia, etc.) * diabetes with hba1c \> 6,5 % and/or manifest diabetic complications * renal failure with plasma creatinine \> 200 µmol/l * ecg abnormalities (scattered ectopic beats ad minor conduction problems are allowed) * permanently bed-ridden inclusion criteria healthy controls: - age and gender matching the htrs exclusion criteria healthy controls: * another chronic disease (such as diabetes mellitus) * permanent use of pharmaceuticals (including hormone drugs) * pregnancy

Keywords: heart transplantation autonomic cardiovascular control acute rejection cardiac allograft vasculopathy
narrative exposure therapy (net) for victims of the recent flood disaster in burundi

Conditions: Posttraumatic Stress Disorder

Summary: in the aftermath of natural disasters, e.g., flood disasters, there is a great need for humanitarian assistance in the domain of psychological support. this is particularly true in post-conflict settings because people have suffered severely from multiple traumatic events and situations during their lives. the narrative exposure therapy (net) is a short-term, culturally sensitive treatment approach that aims to reduce posttraumatic stress disorder (ptsd) symptoms. the investigators want to provide evidence, that net is an effective and efficient module to assist people in the aftermath of natural disasters using the example of the recent flood disaster in burundi. in addition the investigators aim to explore, how traumatic incidences and maltreatment during childhood may influence treatment outcomes.


Eligibility criteria:
inclusion criteria: * individuals severely affected (e.g., who had lost their children) by the flood disaster in bujumbura * all participants were part of the emergency program of the red cross burundi who assisted those most affected by the flood disaster in bujumbura * inclusion criteria for therapy: high degree of symptoms of posttraumatic stress disorder according to the posttraumatic symptom scale - interview (pssi) exclusion criteria: * pregnancy * current substance dependence * psychotic symptoms

Keywords: posttraumatic stress disorder childhood maltreatment
buccal fat pad derived stem cells with cortical tenting in posterior mandible reconstruction

Conditions: Alveolar Bone Loss; Atrophy

Summary: in this study the buccal fat pad derived stem cells (bfpscs) is harvested from buccal fat pad tissue of the patients receiving posterior mandible augmentation. in the test group the patients receive a combination of platelet rich fibrin (prf) and freeze dried bone allograft (fdba) (sureoss, hansbiomed, korea) loaded with bfpscs. the control group receivesfdba (without any cells)+prf. in all the groups the combination are placed between the recipient site and the block graft obtained from lateral ramus. the results will be evaluated by cone beam computed tomography (cbct)and hematoxylin and eosin staining in 6 months.

autogenous bone blocks are harvested from lateral ramus.the buccal fat pad derived stem cells (bfpscs) is harvested from buccal fat pad tissues. the bfpscs will be loaded on freeze dried bone allograft (fdba) (sureoss, hansbiomed, korea). furthermore, twenty milliliters of the venous blood is obtained, placed and collected in a sterile tube, and centrifuged (gac medical) for 14 minutes at 2800 rpm (approximately 400 g). following centrifugation, three layers are separated in the tube: cellular plasma at the top, platelet rich fibrin (prf) clot in the middle and red blood cells at the bottom of the tube. the prf clot is separated by a sterile pincette. the patients in the test group receives bfpscs loaded on fdba with prf for posterior mandible augmentation and the control group receives combination of prf and fdba (lacking any cells). the bfpscs+fdba+prf in the test group and fdba+prf in the control group are placed in the gap between the block graft and recipient site. the results will be evaluated by cone beam computed tomography (cbct) in 6 months and microscopic evaluation of the biopsies by hematoxylin and eosine staining during implant placement.

Eligibility criteria:
inclusion criteria: * patients with posterior mandible edentulism and atrophic bone with less than 4mm bone width at bone crest or less than 8 mm bone height (considering 2-3 mm distance to anatomic structures) exclusion criteria: * smoking, history of malignancy, radiation, chemotherapy, pregnancy, systemic diseases contradicting dental and surgical treatments, conditions or drugs affecting bone remodeling or bone metabolism and connective tissue