Kornimate/medical-research-clean huggingface dataset:
phasix mesh use in complex open ventral hernias study

Conditions: Ventral Hernia

Summary: the purpose of this study is to compare clinical and patient centered outcomes of biosynthetic poly-4-hydroybutyrate meshes versus current care (synthetic polypropylene mesh or suture) for complex ventral hernia repair. the primary outcome for this study will be patients who are major complication free at 2 years postoperative. this will be a composite of hernia recurrence, reoperation, chronic wound complication, or death. secondary outcomes include: surgical site occurences such as surgical site infection, seroma, hematoma and skin dehiscence within 90 days postoperative, emergency room visits withing 90 days postoperative, days in hospital up to 90 days postoperative, abdominal pain, and change in patient centered outcomes measured through the modified activities assessment scale (maas).


Eligibility criteria:
inclusion criteria: * adult patients (18 years or older) with a complex ventral hernia scheduled for repair exclusion criteria: * patients likely to die within 3 years (cirrhosis, terminal cancer, surgeon judgement) * unlikely to follow-up (live out of state, unable to be reached by phone or email) * non-english and non-spanish speakers * pregnant or breast-feeding patients * allergies/hypersensitivities to tetracycline hydrochloride and kanamycin sulfate
workplace wellness: improving your experience at work

Conditions: Sedentary Behavior; Obesity

Summary: the primary objective of study was to compare affective (i.e., highlighted emotional benefits), instrumental (i.e., highlighted other health benefits), and self-regulation (i.e., demonstrated ways to plan, set goals, etc.) interventions in terms of their ability to motivate less sitting in the workplace. research of this type is important because people sit for long periods of time at work which adversely affects their health and productivity. it was hypothesized that the affective and self-regulation groups would sit less than the instrumental and control groups based on evidence indicating that affective attitude (i.e., emotional evaluation of the behavior) and self-regulation techniques tend to predict behavior.


Eligibility criteria:
inclusion criteria: * from a local workplace in victoria * full-time employee (i.e., greater than 35 hours per week) * reported over 5.5 hours of sitting per day at work * agreed to attend the 3 intervention sessions exclusion criteria: * not from a local workplace in victoria * not a full-time employee (i.e., 35 hours or less per week) * reported less than 5.5 hours of sitting per day at work * did not agree to attend the 3 intervention sessions
tackling intrusive traumatic memories after a difficult birth

Conditions: Posttraumatic Stress Disorder; Intrusive Traumatic Memories

Summary: this proof-of-principle study aims to investigate the effects of a brief behavioural procedure including a computerized visuospatial task (the computer game "tetris") preceded by a reactivation of the traumatic memory of childbirth, on birth-related intrusive traumatic memories and other postpartum posttraumatic stress symptoms. women who report birth-related intrusive memories after 6 weeks postpartum will monitor their intrusive traumatic memories in a daily diary. after two weeks of diary, they will meet a psychologist to briefly evoke the memory of their birth, and receive a brief behavioural procedure including playing tetris. participants will then continue to complete an intrusive traumatic memory diary during two weeks. it is predicted that they will report fewer intrusive memories in the two weeks following the intervention, compared to the two weeks before. this will inform the potential future development of a simple computerized intervention procedure to reduce distressing psychological symptoms after traumatic childbirth.


Eligibility criteria:
inclusion criteria: * gave birth at the lausanne university hospital * gave written consent * have at least 4 related-to-childbirth intrusions over the two weeks prior to recruitment, and at least 2 related-to-childbirth intrusions during the pre-intervention diary * gave birth more than 6 weeks ago * is able to distinguish intrusions linked to the traumatic childbirth from intrusions linked to other traumatic events exclusion criteria: * gave birth to a stillborn child * not fluent in french * severe illness of mother or infant (e.g. cancer, cardiovascular disease, severe neurodevelopmental difficulties, malformations) * have an established intellectual disability, or psychiatric history such as psychotic illness * alcohol abuse and/or illegal drug use * currently receiving psychological care in relation with the traumatic birth experience
resilience through interventions for successful early outcomes

Conditions: Parenting Intervention; Stress; Caregiver Child Relationship; Child Behavior Problem; Mental Health

Summary: purpose: the purpose of this research is to determine the effects of attachment and biobehavioral catch-up (abc), an evidence-based parenting program, on stress biomarkers in children. participants: the study will involve approximately 150 caregiver-child dyads, with children aged between 24 and 42 months. participants will include primary caregivers fluent in english or spanish, along with their children who have experienced social risk factors for adversity. procedures (methods): participants will be randomly assigned to either receive the abc parenting program (10 sessions) immediately or be placed on a wait-list, receiving the program after about 4 months. the study procedures include caregivers completing online surveys, engaging in play-based observational tasks with their children, and collecting non-invasive biological samples (saliva, cheek swab, hair) from the children and saliva samples from the caregivers at 2-3 time-points.


Eligibility criteria:
parent/caregiver inclusion criteria : * aged 18 or older * speaks english or spanish * is the parent or legal guardian with legal custody of a child aged between 24 months and 42 months * is a primary caregiver/parent * has a home-like environment in which to participate in the intervention child inclusion criteria: * aged between 24 months and 42 months at enrollment * lives with the parent/caregiver at least 50% of the time * has experienced social risk factors, including low income, community or family violence, previous trauma/adversity exposure, prolonged separation from caregiver, significant difficulties in relationship with caregiver child exclusion criteria * has a diagnosed genetic or congenital disorders, including but not limited to down syndrome, cerebral palsy, seizure disorders, endocrine disorders (or is using steroid medications, including human growth hormone), or was born with birth defects

Keywords: attachment and biobehavioral catchup parenting intervention rise study child behavior biomarkers
repetitive applications of pruritogens and effects of a cutaneous-induced pain stimulation on nonhistaminergic itch perception

Conditions: Histamine; Cowhage

Summary: in this experiment, the investigators would like to test following hypotheses: repetitive cutaneous administration of pruritogens will lead to a more robust and longer lasting itch sensation compared with a single application. the aim of this project is to investigate a new itch model based on repetitive administration of three different pruritogens: histamine (histaminergic itch), cowhage, and bam 8-22 (non-histaminergic itch).

chronic itch affects approximately a fifth of the global population and is associated with substantial negative consequences for the affected individuals. furthermore, there is a lack of efficient treatment options for chronic itch. in order to mimic a clinical itch condition as presented in patients, the aim of the project is to investigate a new itch model based on repetitive administration of three different pruritogens: histamine (histaminergic itch), cowhage, and bam 8-22 (non-histaminergic itch). the hypothesis is that repetitive cutaneous administration of pruritogens will lead to a more robust and longer-lasting itch sensation compared with a single application. this proposal for a new itch model could better mimic clinical itch conditions and be used to investigate fundamental mechanisms, new anti-pruritic drugs, and their possible mechanisms of action.

Eligibility criteria:
inclusion criteria: * healthy men and women * 18-60 years * speak and understand english exclusion criteria: * pregnancy or lactation * drug addiction defined as any use of cannabis, opioids, or other addictive drugs * previous or current history of neurological (e.g. neuropathy), immunological (e.g. asthma, immune deficiencies, arthritis) musculoskeletal (e.g. muscular pain in the upper extremities,), cardiac disorder, or mental illnesses that may affect the results * lack of ability to cooperate * current use of medications that may affect the trial such as antihistamines, antipsychotics, and pain killers, as well as systemic or topical steroids * skin diseases (e.g. atopic dermatitis, pruritus nodularis, eczema, psoriasis) * moles, scars, or tattoos in the area to be treated or tested. * consumption of alcohol or painkillers 24 hours before the study days and between these * acute or chronic pain * participation in other trials within one week of study entry (four weeks in the case of pharmaceutical trials)
interstim basic evaluation lead post-market clinical follow-up study

Conditions: Overactive Bladder; Urinary Urge Incontinence; Urgency-frequency Syndrome

Summary: post-market clinical follow-up for continued assessment of safety and performance of the interstim basic evaluation lead and foramen needle(s) used during a therapy evaluation.


Eligibility criteria:
inclusion criteria: 1. subjects 18 years of age or older 2. candidate for sacral neuromodulation in accordance with the interstim system labeling 3. have a diagnosis of overactive bladder (oab) as demonstrated by either urinary urge incontinence and/or urinary frequency on a 3-day voiding diary 4. willing and able to accurately complete study diaries, questionnaire, attend visits, and comply with the study protocol 5. willing and able to provide signed and dated informed consent exclusion criteria: 1. have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia) 2. have implantable pacemakers, or defibrillators 3. have primary stress incontinence or mixed incontinence where the stress component overrides the urge component 4. have knowledge of planned mris, diathermy, microwave exposure, high output ultrasonic exposure, or radio frequency (rf) energy exposure not included within the scanning conditions provided with the interstim system labeling 5. women who are pregnant or planning to become pregnant during participation in the study 6. characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements 7. concurrent participation in another clinical study that may add additional safety risks and/or confound study results.

Keywords: overactive bladder urinary urge incontinence urgency-frequency syndrome
trial to evaluate the safety of ttac-0001(tanibirumab) in recurrent glioblastoma

Conditions: Recurrent Glioblastoma

Summary: study design - multicenter, open-label, 3 arms, stepwise, phase ⅱa clinical trial study objective: 1. primary - to evaluate the safety of ttac-0001 in patients with recurrent glioblastoma. 2. secondary - to determine the efficacy of ttac-0001 in patients with recurrent glioblastoma. 3. exploratory * to evaluate pharmacokinetic (pk) parameters of ttac-0001 in patients with recurrent glioblastoma * to evaluate pharmacodynamic (pd) parameters by clinical biomarker test study methodology patients will be sequentially enrolled from the 1st arm. an enrollment criterion to the next arm is defined as no patients in the previous treatment arm showing grade ≥3 of hemangioma or other dose limiting toxicities (dlt). a safety review committee (src) will convene to determine the patient's safety with a decision on enrollment into the next arm or change in dosing frequency of study drug in the above case. a patient who is withdrawn from the study before the completion of the 1st cycle can be replaced with another patient. patients will be treated for up to 1 year, unless a cause for termination occurs, such as progression of disease (pd) or the withdrawal of consent.


Eligibility criteria:
inclusion criteria: * both male and female patients ≥19 years old * diagnosed with primary glioblastoma by histopathological examination and confirmed recurrent glioblastoma by magnetic resonance imaging (mri) scans after concomitant temozolomide chemotherapy with radiotherapy (ccrt). one previous recurrence/progression of glioblastoma with reintroduction/altered schedule of temozolomide is allowable. * at least one confirmed measurable lesion or non measurable lesion by response assessment in neuro-oncology (rano) criteria * karnofsky performance status (kps) ≥ 80 * a person who satisfies the following criteria in hematologic, renal, and hepatic function tests * at least 12 weeks of expected survival time * signed informed consent exclusion criteria: * diagnosed with other malignant tumor within 2years * uncontrolled ht or seizure, class iii or iv heart failure, oxygen dependent disease, active psychiatric disorder * not recovered grade 2 ae due to previous ccrt * major surgery or other investigational drug treatment within 4 weeks * pregnant/lactating female and female/male potential childbearing without contraception * severe drug hypersensitivity or hypersensitivity to a therapy similar to the study drug * expectation of poor compliance * previous therapy with vegf targeted agent
effectiveness of synchronized tele-exercise

Conditions: Healthy

Summary: the aim of this study is to determine the effect of telehealth-synchronized group exercise on sleep and quality of life, and secondarily, on the health and body perception of healthy young adults. this study is planned as a randomized double-blind controlled clinical study.

the aim of this study is to determine the effect of telehealth-synchronized group exercise on sleep and quality of life, and secondarily, on the health and body perception of healthy young adults. this study is planned as a randomized double-blind controlled clinical study. the sample size was calculated using g\*power 3.1.9.2, which required 42 patients and a size effect of 0.8, 80% power, 1:1 allocation ratio, and an error probability of 0.05. forty-eight participants were planned to be included in the study, based on the probability that 15% of the patients could be excluded.

Eligibility criteria:
inclusion criteria: * being a volunteer, * being in the age range of 18-25, * having no barriers to online sessions through a computer, * having no visual impairment. exclusion criteria: * having experienced a physical injury in the last 3 months * having any major disorder, * learning difficulty, * having a mental disorder that could affect the results
comparison of mood disorders screening scales in geriatric oncology

Conditions: Mood Disorders

Summary: the objective of this study is to evaluate the scales commonly used in geriatrics and oncology distress thermometer ( analogue scale rated from 0 to 1 for the emotional distress ) , the gds15 (15 issues closed binary response seeking signs of depression ) the hads (14 questions assessing the intensity of anxiety signs and signs of depression listed 0-3 ). the prospective observational study will be conducted in parallel on two sites ( university hospital centre and françois baclesse ) after informed patient information. it will be offered to patients 70 years and over with a new diagnosis or relapse of cancer or haematological malignancies in the hospital to meet the mood disorder screening questionnaires .

there are various tools validated and recommended by the sio and sfpo for screening mood disorders in geriatric oncology . the choice among them depends on the usual practices of the various teams , only some scales assessing depressive signs and other signs of anxiety too. none were assessed in a population aged diagnosis of cancer or hematologic malignancy in pre- therapeutic situation. the objective of this study is to evaluate the scales commonly used in geriatrics and oncology distress thermometer ( analogue scale rated from 0 to 1 for the emotional distress ) , the gds15 (15 issues closed binary response seeking signs of depression ) the hads (14 questions assessing the intensity of anxiety signs and signs of depression listed 0-3 ) the prospective observational study will be conducted in parallel on two sites ( university hospital centre and françois baclesse ) after informed patient information. it will be offered to patients 70 years and over with a new diagnosis or relapse of cancer or haematological malignancies in the hospital to meet the mood disorder screening questionnaires . if one test is abnormal , a clinical psychological care will be offered . when returning home : telephone contact will be made the same day with the doctor , asking him to please make thymic revaluation within 2 weeks ( informed patient). it will be sent to the doctor by post a rubric of major depressive episode criteria of the dsm v to return . if the patient remains hospitalized , the doctor taking care of patient will be contacted to obtain the same information . in addition, the investigators will study the impact on the management (change or introduction of an antidepressant and / or anxiolytic use of psychotherapy or psychological counseling ... ) to 5 weeks

Eligibility criteria:
inclusion criteria: * patient 70 years and older with diagnosis of cancer or haematological malignancies , * new diagnosis or relapse announced * supported in the 2 c among : in consultation , or hospital geriatric or oncology / hematology specialty * affiliated health insurance exclusion criteria: * cognitive problems preventing self
feasibility study corpps

Conditions: Esophageal Neoplasm; Laryngeal Neoplasms

Summary: the incidence of cancer in france has increased by +135% to reach nearly 400,000 new cases in 2018. the ten-year cancer control strategy 2021-2030 and the health innovation plan have defined strategic axes. almost all of these axes are addressed in our project. firstly, the main objective of our study is to improve the quality of life of patients. secondly, pharyngolaryngeal and oesophageal cancers are among the cancers with a poor prognosis in adults. thirdly, the project provides access to personalised supportive care for all patients at all times. finally, the secondary objectives of this study are the prevention of post-operative complications (infectious, thrombo-embolic, pain...).


Eligibility criteria:
inclusion criteria: * hospitalized for initial surgical management of esophageal or laryngeal cancer * admitted to a conventional ward after partial oesophagectomy or total laryngectomy in a neoplastic setting * patient giving consent to participate in the study * affiliated to the compulsory health insurance scheme, regardless of the scheme exclusion criteria: * patient who did not follow the previously described course of care prior to admission to the ward * esophagectomy with total circular pharyngo-laryngectomy * total esogastrectomy * illiterate, visually impaired patient * minor, or adult under guardianship or curatorship, under judicial protection, person deprived of liberty

Keywords: cancer physical and psychosocial rehabilitation digital platform esophagectomy laryngectomy
latent pulmonary hypertension (ph) in chronic thromboembolic pulmonary hypertension (cteph )after endarterectomy and influence of exercise and respiratory therapy

Conditions: Pulmonary Hypertension; Chronic Thromboembolic Pulmonary Hypertension

Summary: severe cteph leads to an impaired physical capacity and a restricted quality of life and poor prognosis. pulmonary endarterectomy represents the best choice as therapy, when the thrombi are located in the central pulmonary vessels and therefore can be operated. by this operation the pulmonary artery pressure can be normalised and the patients' survival improved. up to now, after successful endarterectomy patients only receive anticoagulation. despite operation many patients remain symptomatic and are restricted in their physical capacity. therefore a hypothesis of this project is that most of the patients, even after successful operation, show peripheral vascular remodelling with a ventilation-perfusion mismatch and elevated pulmonary pressure during exercise. in this study we aim to analyse how many patients with cteph after endarterectomy show elevated pulmonary artery pressures at rest or during exercise and are limited in their physical capacity, hemodynamics, oxygen uptake and quality of life and need further therapy. another aim is to examine whether exercise and respiratory therapy may improve the patients postoperatively. therefore 30 patients with cteph \> six months after endarterectomy, with ongoing restricted exercise capacity shall be included. after baseline examination in the university hospital heidelberg the patients receive exercise and respiratory therapy for three weeks. the patients will receive further examinations at the end of rehabilitation after 3 weeks and after 15 weeks. all examinations include medical history, family history, physical examination, ecg and echocardiography at rest and during exercise, cardiopulmonary exercise testing, assessment of the respiratory muscle strength, the sf-36 questionnaire for quality of life, laboratory testing and mri. rehabilitation will be conducted in the clinic for rehabilitation koenigstuhl, heidelberg. participants will be randomised into two groups, a control group receiving a conventional therapy for three weeks, in which physical exertion is to be avoided and a training group with additional exercise and respiratory therapy.


Eligibility criteria:
inclusion criteria: * a screening 1. informed consent 2. men and women 18 - 75 years 3. patients ≥ 6 months after endarterectomy because of chronic thromboembolic pulmonary hypertension (cteph) * b training see a + all patients who showed a restricted physical capacity in the screening: * latent pulmonary hypertension * restricted physical capacity exclusion criteria: 1. pregnancy or lactation 2. change in medication during the last 2 months 3. patients with signs of right heart decompensation 4. disease which affects the gait 5. unclear diagnosis 6. acute illness, infection, fever 7. severe lung diseases with fev1 \<50% and tlc\< 70% of reference

Keywords: latent