Kornimate/medical-research-clean huggingface dataset:
efficacy and safety study of tanezumab subcutaneous administration in osteoarthritis - a subcutaneous/intravenous bridging study

Conditions: Osteoarthritis; Arthritis; Pain

Summary: this is an efficacy and safety study of 3 doses (2.5 mg, 5 mg and 10mg) of tanezumab administered subcutaneously versus placebo. this study will also compare a subcutaneous (sc) administration of 10 mg of tanezumab) with an intravenous (iv) administration of 10 mg of tanezumab. each person will receive an iv infusion and a sc infusion. the study will last 16 weeks for those who wish to enter a 64-week extension study or 24 weeks for those who do not.

this study was terminated on 08 nov 2010 following a us fda clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 june 2010 for potential safety issues.

Eligibility criteria:
inclusion criteria: * diagnosis of osteoarthritis (oa) of the knee according to american college of rheumatology (acr) criteria with a kellgren- lawrence score of greater than or equal to 2 * 18 years of age or greater * two methods of birth control one of which must be barrier if of childbearing potential * willing to discontinue pain medication except as permitted per protocol exclusion criteria: * pregnancy or wishing to be pregnant during the course of the study, lactating women * body mass index (bmi) greater than 39 * clinically significant cardiac, neurological, psychiatric conditions and other conditions that are excluded by the protocol. * previous exposure to a nerve growth factor (ngf) antibody

Keywords: safety efficacy parallel group double-blind multicenter injection infusion osteoarthritis bridging subcutaneous intravenous tanezumab
the effect of nurse navigation program on lung cancer patients

Conditions: Non Small Cell Lung Cancer

Summary: the study aims to determine the effect of the nurse navigation program (lungcann), which is performed in line with the supportive care needs of newly diagnosed non-small cell lung cancer patients, on the level of anxiety-depression, adherence to the disease, and quality of life. the study was designed as a randomized study with a control group. this study will be carried out with a total of 84 nsclc patients, 42 of whom were in the intervention group and 42 in the control group, whose treatment was started in akdeniz university medical oncology outpatient clinic and met the inclusion criteria of the sampling. nurse navigation program will be applied for 12 weeks from the diagnosis of nsclc patients in the intervention group. the intervention protocol of the study is abbreviated as "lung cancer nurse navigator" \[lungcann\]. within the scope of the lungcann program, face-to-face patient education, patient education booklet, face-to-face, and telephone navigation initiatives were planned. patient identification form, depression anxiety stress scale (dass 21), chronic disease adjustment scale, eortc qlq 30 quality of life scale-/ lc-13, and navigation and interview steps form will be used to collect data.


Eligibility criteria:
inclusion criteria: * know how to read and write no hearing or speech problems be able to use the phone the primary medical diagnosis is non-small cell lung cancer karnofsky performance scale score of 70% or higher patients with a stress thermometer of 4 and above at most six weeks past the date of diagnosis exclusion criteria: * patients with cognitive problems expected life expectancy is less than three months

Keywords: cancer nurse navigator nurse navigation program individualized care anxiety-depression adaptation to the disease quality of life
reach vet implementation program evaluation

Conditions: Suicide

Summary: the va's office of mental health and suicide prevention implemented an new program to increase suicide prevention outreach for veterans at highest risk for suicide. using a statistical model, reach vet, short for recovery engagement and coordination for health - veterans enhanced treatment, uses information from veterans' health records to identify those who are at a higher risk for suicide, hospitalization, illness, or other negative outcomes. once a veteran is identified, his or her va mental health or primary care provider reaches out to check on the veteran's well-being and review their treatment plan to determine if enhanced care is needed. the goal of the current study was to evaluate the implementation of this program. the objectives of this evaluation were to evaluate how well this program is put into place using an implementation strategy called virtual external facilitation, and to collect data about the cost of the program and the strategy.

the va's office of mental health and suicide prevention is implemented an innovative new program to increase suicide prevention outreach and target veterans at highest risk for suicide. using a new predictive model, reach vet, short for recovery engagement and coordination for health - veterans enhanced treatment, analyzes existing data from veterans' health records to identify those who are at a statistically elevated risk for suicide, hospitalization, illness, or other adverse outcomes. once a veteran is identified, their va mental health or primary care provider reaches out to check on the veteran's well-being and review their condition(s) and treatment plans to determine if enhanced care is needed. the goal of the proposed study is to evaluate the implementation of reach vet. the objectives of this evaluation are to: 1. evaluate the implementation of reach vet using virtual external facilitation, and 2. collect preliminary data about the cost and cost offsets. the current evaluation will examine the impact of a virtual external facilitation strategy on the implementation of reach vet in 28 medical facilities across 7 veteran integrated service networks (visns) in a stepped wedge design. primary implementation outcomes include metrics of reach vet implementation: coordinator assignment, provider assignment, care evaluation, and attempted outreach. qualitative interviews will be conducted with implementation facilitators, suicide prevention coordinator(s), clinical leadership, and providers to identify barriers and facilitators to implementation of reach vet and the experience of facilitation. secondary data will be collected on the cost of the intervention and the cost of implementation strategy.

Eligibility criteria:
inclusion criteria: * va employee at a facility receiving virtual external facilitation * involved in reach vet implementation exclusion criteria: * not a va employee * not employed at a facility receiving virtual external facilitation * not involved in reach vet implementation

Keywords: suicide prevention implementation facilitation
"atriogenic tricuspid selected, omics profile, multimodality imaging and clinical outcomes"

Conditions: Tricuspid Valve Insufficiency

Summary: the aim of our study is to investigate the molecular mechanisms underlying remodeling of the tricuspid valve apparatus in patients with itf and isolated af, in comparison with patients with itf from right ventricular remodeling, patients with atriogenic mi and left ventricular remodeling. to achieve these aims, markers obtained from cardiovascular imaging methods, such as 3d echocardiogram, and biomarkers isolated from the peripheral blood of the study participants will be considered.

advances in echocardiography and, in particular, the development of three-dimensional echocardiography have allowed a more accurate analysis of the morphology of the tricuspid valve and a detailed understanding of the mechanisms underlying its insufficiency. from a clinical point of view, itf is divided into a primary form, less frequent (8-10%), caused by primary alterations of the tricuspid valve apparatus, acquired or congenital, and in a "functional" form, the most frequent, conventionally associated in most cases with coexisting pathologies of the left heart or primitive pathologies of the right heart. more recently, long-lasting persistent atrial fibrillation (af) has been associated with the development of itf in the presence of structurally normal valve leaflets, preserved right ventricular size and function, and right atrial dilatation. this form of itf, defined as "atrial functional", could benefit from a different therapeutic management compared to the classic form, more commonly caused by right ventricular dilatation and dysfunction ("ventricular functional" it). however, not all patients with af and tricuspid annulus dilatation develop valvular insufficiency and, on the other hand, with the same valvular annulus dilatation and right atrial size, the prevalence of severe it forms is extremely variable. this could depend on different adaptive mechanisms implemented by the valve leaflet tissue that lead to their growth or not in response to atrial remodeling and valve annulus dilatation, representing a key factor in the development and progression of the disease. atriogenic itf. if confirmed, these observations could lead to a better prognostic classification and different therapeutic perspectives for patients with af at risk of developing forms of severe itf and congestive heart failure.

Eligibility criteria:
inclusion criteria: - admitted to the department of cardiological, neurological and metabolic sciences of the san luca hospital with a diagnosis of persistent atrial fibrillation exclusion criteria: * patient aged \<18 years; * pregnancy; * chronic inflammatory diseases; * autoimmune diseases; * tumor diseases; * chronic renal failure with egfr \< 30 ml/min;

Keywords: functional tricuspid valve regurgitation atrial fibrillation
mapracorat ophthalmic suspension for the treatment of ocular inflammation following cataract surgery

Conditions: Cataract

Summary: the objective of this clinical study is to compare the safety and efficacy of mapracorat ophthalmic suspension, 3% to vehicle for the treatment of postoperative inflammation and pain following cataract surgery.


Eligibility criteria:
inclusion criteria: * participants who are candidates for routine, uncomplicated cataract surgery * participants who, in the investigator's opinion, have potential postoperative pinhole snellen visual acuity (va) of at least 20/200 in the study eye. * participants must be willing to wait to undergo cataract surgery on the fellow eye until after the study has been completed. exclusion criteria: * participants who are expected to require concurrent ocular therapy (either eye) with nonsteroidal anti-inflammatory drugs (nsaids), mast cell stabilizers, antihistamines, or decongestants. * participants who are expected to require treatment with any systemic or ocular (either eye) corticosteroids or glucocorticoids. * participants who are expected to require concurrent ocular therapy with immunosuppressants (eg, restasis). * participants who have known hypersensitivity or contraindication to the study drug(s) or their components. * participants participating in any drug or device clinical investigation within 30 days prior to entry into this study and/or during the period of study participation.

Keywords: inflammation pain ocular surgery
promoting healing of injured nerves with electrical stimulation therapy

Conditions: Nerve Injury; Peripheral Nerve Injuries; Peripheral Nerve Injury Upper Limb; Nerve Palsy

Summary: this study is evaluating a new therapeutic use of electrical stimulation to promote nerve healing and improve functional recovery following surgical intervention for peripheral nerve injury in arm. participants will be randomized into one of two groups, treatment or control, with all participants receiving standard of care treatment for the nerve injury. the treatment group will also receive a single dose of the therapeutic stimulation during the surgical intervention for their nerve injury.

preliminary research has shown that delivering a brief period of electrical stimulation following nerve repair promotes nerve healing and functional recovery. this pilot study is investigating the use of a single dose of therapeutic electrical stimulation to promote nerve healing. the therapy is delivered as part of the surgical intervention to address peripheral nerve injury in the arm.

Eligibility criteria:
inclusion criteria: * upper extremity mixed or motor nerve injury from the brachial plexus to the wrist crease. * candidate for surgical intervention. * indicated for surgical repair by nerve transfer, primary repair, or nerve grafting. * are age 18-80 years. * signed and dated informed consent form. exclusion criteria: * severe comorbid condition, such as arrhythmia or congestive heart failure, preventing surgery. * primary repair requiring graft \>6cm. * nerve reconstruction occurring \>12 months post injury. * age less than 18 or greater than 80 years. * all contraindications to included/required surgical procedure, including but not limited to language barriers, mental status barriers, inability to consent, and pregnancy/lactation.

Keywords: therapeutic electrical stimulation brief electrical stimulation nerve regeneration nerve injury nerve healing nerve repair
a speech sound and phonemic awareness intervention in flemish early childhood education

Conditions: Other Developmental Disorders of Speech and Language

Summary: the language intervention 'kaatje klank' is designed for stimulating the speech production and speech perception skills of 4-year-olds in an early childhood educational setting, in order to stimulate early literacy skills. these skills are crucial skills for technical reading in later ages. good reading skills are an important condition for academic success. to measure the effect of the language intervention 'kaatje klank', the intervention will be applied in six dutch preschool classes (n = 100 children, 50% native speakers of dutch, 50% non-native speakers) during 12 weeks (daily). teachers will be trained and observed using a coaching trajectory.to measure the effect on speech production and perception skills, a pre- and posttest and a comparison with a matched control group (n = 100 children, 50% native speakers of dutch, 50% non-native speakers) will be used. the control group will receive a different language intervention which focuses on vocabulary development (world-project).


Eligibility criteria:
inclusion criteria: * in eary childhood education in flanders (2de kleuterklas) exclusion criteria: * language or speech disorder * less than 1 year acquiring dutch
contribution of attachment and educational practices in the expression of adhd in school-aged children

Conditions: Attention Deficit Hyperactivity Disorder

Summary: adhd is a neurodevelopmental disorder characterized by the presence of persistent signs of associated hyperactivity-impulsivity and/or inattention that impair the child's functioning or development. the involvement of genetic factors has been shown in numerous studies. other studies have also highlighted the contributions of parent-child interaction in the development, expression and persistence of symptoms.however, the mechanisms by which parenting practices and attachment may influence adhd symptoms remain unclear. the aim of this study is to evaluate the influence of attachment style of the child, the educational practices and the presence of attentional/executive disorders of parents on the expression of adhd in children aged 7 to 10. this prospective empirical research will compare children with adhd and their parents to a matched control group.


Eligibility criteria:
inclusion criteria: male or female patients ages 7 to ≤10 years with adhd (study group) or td children matched by gender and socio-economic factors (control group) and their parents. french-speaking population willing and able to comply with scheduled visits and study procedures. written informed consent/assent, according to local guidelines, signed by the patient and / or by the parents or legal guardian prior to any study related screening procedures are performed. exclusion criteria: children with intellectual disabilities (iq \<80). epilepsy. prematurity. objectified neurological sequelae. specific language impairment or severe learning disabilities. contraindication to stopping treatment for adhd

Keywords: child attachment parenting adhd executive functions
duration of protection from pneumonia after pneumococcal vaccination in hemodialysis patients

Conditions: CKD (Chronic Kidney Disease) Stage 5D; Pneumonia

Summary: the investigators compare two strata of vaccinated patients: those recently vaccinated and those vaccinated more than two years ago. the primary objective is to compare pneumonia rates between the groups. as exploratory objectives, the investigators will describe the anti-pneumococcal antibody titers in hemodialysis patients as a function of time since vaccination, and determine factors influencing antibody kinetics. further exploratory objectives investigate the relationship between antibody titers and the incidence of pneumonia in hemodialysis patients and extrapolate a possible cut-off for protection from pneumonia.

participating sites will screen all hemodialysis patients at their outpatient dialysis clinic for eligibility. eligible patients will be approached and informed by their treating physician. if a patient agrees to participate in the study and to sign an informed consent form, basic data regarding vaccination history, underlying disease, etc. will be entered or electronically imported into the study ecrf. pneumococcal antibody titers will be drawn at baseline and every 3 months. for newly vaccinated patients baseline titers will be drawn 4 weeks after the vaccination. dzif ctus will coordinate titer assessment schedules and inform the participating physicians of upcoming blood samplings. the samples will be taken on dialysis days and thus constitute only a minimal additional burden for both patients and physicians. dzif ctus will actively follow up on study patients for 2 years after enrolment. this follow-up will include validation of all hospitalizations and deaths documented in an electronic registry database to assess whether the primary endpoint (pneumonia) occurred. additionally, dialysis units will be contacted every 6 months to assess if pneumonia occurred, which did not require hospitalization. dzif ctus will document titer assessment results in the ecrf. titers will not be disclosed to the attending physicians because revaccination due to knowledge of titers would produce bias. all therapies and diagnostics including vaccinations will be administered solely as part of clinical routine and as recommended by appropriate guidelines (e.g. rki stiko recommendations).

Eligibility criteria:
inclusion criteria: * signed informed consent form including enrolment in registry database (qin-registry) * patients with stage 5 chronic kidney disease treated with chronic hemodialysis * patients who are either already vaccinated or eligible and willing to be vaccinated against pneumococcal infection in accordance with current stiko recommendations * age of 18 years or older exclusion criteria: * patients unwilling/ineligible for vaccination under current stiko recommendations

Keywords: hemodialysis pneumococcal vaccination
use of hyaluronic acid as a therapeutic strategy for bone repair in human

Conditions: Alveolar Bone Loss

Summary: the aim of this study is to evaluate the effects of hyaluronic acid (ha) on bone healing in human dental sockets.


Eligibility criteria:
inclusion criteria: * orthodontic need for bilateral extraction of lower first premolars exclusion criteria: * alcoholism, smoking, drug use and abuse of drugs; systemic diseases: uncontrolled diabetes, blood dyscrasias, kidney or heart failure and osteoporosis; clinical or radiographic signs of pathological processes in the bone;

Keywords: hyaluronic acid bone repair dental socket cone beam computed tomography
colchicine for prevention of perioperative atrial fibrillation in patients undergoing thoracic surgery pilot study

Conditions: Atrial Fibrillation; Thoracic Surgery

Summary: the purpose of this pilot study is to determine the feasibility of comparing colchicine to placebo for the prevention of new onset atrial fibrillation in patients undergoing general thoracic surgery and establish the foundation for a large, multi-centre, clinical trial.


Eligibility criteria:
inclusion criteria: * all patients ≥55 years of age undergoing intra-thoracic surgery for a resection of tumor in lung. exclusion criteria: * in af prior to surgery\*, * undergoing minor thoracic interventions/ procedures (i.e., chest tube insertion, needle pleural/lung biopsies, or minor chest-wall surgeries), or * with contraindications to colchicine (i.e., allergy, or myelodysplastic disorders or estimated glomerular filtration rate \[e-gfr\] \<30 ml/min/1.73m) * clarification: patients with history of af who are in sinus rhythm during enrollment will be eligible for recruitment. patients who have no history of af and are found to be in af at the time of enrollment will not be eligible.
non-invasive brain signal training to induce motor control recovery after stroke

Conditions: Stroke

Summary: the purpose of this trial was to evaluate the benefits of combination motor learning training and brain computer interface training for restoring arm function in people with stroke. our aim was to determine whether the surface-acquired brain signal (electroencephalography (eeg)) can feasibly be used as a neural feedback system to drive more normal motor function in stroke survivors.

the financial burden and human suffering are devastating after stroke due to the lack of rehabilitation protocols that can restore normal brain and motor function. conventional treatment does not restore normal motor function to many stroke survivors. the majority of available treatments are directed at the peripheral nervous system (arms/legs). since stroke occurs in the brain and results in brain damage and dysfunction, a more direct approach may be to re-train the brain by directly treating the activation of brain signals that control movement. the purposes of this study are to determine if motor learning, functional electrical stimulation (fes), and brain computer interface (bci) training are beneficial for restoring arm function in people who have had a stroke, and to determine if the surface-acquired brain signal \[electroencephalography (eeg)\] can be re-trained to provide more normal motor function in stroke survivors. the primary purpose of this study is to determine the efficacy of the motor learning tasks in stroke recovery. in the study, scientists will use two different and complimentary brain signal training components to restore more normal motor control of a motor task (elbow, wrist, or finger movement task). specifically targeting, invoking, and training the surface-acquired eeg brain signal, and integrating brain signal training into motor learning training of upper limb motor tasks, may result in greater motor restoration when compared to a comprehensive motor learning intervention without eeg brain signal training. eight people who had a stroke were enrolled in the experimental group. they received brain signal training and comprehensive motor learning based therapy. an additional 5 healthy adults were enrolled in order to study their ability to acquire brain signal control and the characteristics of their brain signal during the tasks that the stroke participants attempted.

Eligibility criteria:
inclusion criteria: * medically stable and \>/= 6 months post stroke * difficulty using upper limb for functional tasks * \>21 years old exclusion criteria: * chronic, progressive medical condition (i.e. parkinson's disease)

Keywords: stroke motor learning rehabilitation of upper extremity functional electrical stimulation fes brain computer interface bci coordination motor control