Kornimate/medical-research-clean huggingface dataset:
efficacy, safety, and tolerability of hb0043 in hidradenitis suppurativa patients.

Conditions: Hidradenitis Suppurativa

Summary: the purpose of this study is to assess efficacy safety and tolerability of hb0043 in adult patients with moderate to severe hs.

the total duration of the study is 28 weeks and consists of: screening (up to 4 weeks), treatment period (20 weeks) and safety follow-up (treatment-free follow-up for 4 weeks). participants who prematurely discontinue study treatment are encouraged to remain in the study. participants who do not wish to remain in the study will enter a 4-week safety follow-up period.

Eligibility criteria:
inclusion criteria: * 1. understand the research procedure of this study and provide written informed consent; 2. male or female, age 18 years or greater; 3. diagnosis of hs with a disease duration of at least 6 months before screening; 4. moderate to severe hs, concurrently meeting the following three criteria: 1. hs lesions in at least 2 distinct anatomic area; 2. one of the hs lesions must be hurley stage ii or hurley stage iii; 3. total abscess and inflammatory nodule (an) count of greater than or equal to 3; 5. acceptance by the patient, of childbearing age, to use safe contraceptive methods throughout the study, including six months of follow-up. exclusion criteria: * 1. participants with known hypersensitivity to hb0043 or any of its excipients; 2. participant has a draining fistula count of ≥20 at the screening visit; 3. presence of other active autoimmune diseases except hs, including but not limited to psoriasis, psoriatic arthritis, rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, and uveitis; 4. participant has any other active skin disease or condition that may interfere with the assessment of hidradenitis suppurativa; 5. history of lymphoproliferative disorders or any known malignancy within five years prior to the screening visit (excluding treated and cured cutaneous squamous cell carcinoma, basal cell carcinoma, carcinoma uterine in situ, or intraductal breast cancer in situ); 6. history of recurrent or recent serious infection; 7. participant has active tuberculosis (tb) or concurrent treatment for latent tb or evidence of hepatitis b virus (hbv) or hepatitis c virus (hcv) or human immunodeficiency virus (hiv) infection; 8. pregnant or lactating women; 9. any reason why, in the opinion of the investigator, the patient should not participate.
a study of the safety and efficacy of long-term nebivolol use in hypertensive patients

Conditions: Hypertension

Summary: the study was conducted to determine the long-term safety and efficacy of nebivolol in patients with mild to moderate hypertension. this was an extension of the phase iii dose ranging studies neb 202, 302 and 305. nebivolol was studied as monotherapy and in conjunction with add-on antihypertensive therapy.

this was an international, multicenter parallel group, 9-month extension study with a 4-week follow-up phase to evaluate the long-term safety and efficacy of nebivolol administered orally once daily in patients with mild to moderate hypertension (defined as an average sitting diastolic blood pressure greater then or equal to 95 mmhg and less then or equal to 109 mmhg when untreated, based on entry into neb 202, neb 302 or neb 305). patients were permitted protocol-defined concomitant use of diuretic or calcium antagonist. after successful completion of one of the 3-month efficacy "feeder" studies, patients were eligible to continue nebivolol treatment in this 9-month extension study. patients who completed the extension phase and received only nebivolol monotherapy during the extension phase were eligible to enter the 1-month follow-up phase.

Eligibility criteria:
inclusion criteria: * to enter the long-term treatment phase, patients must have successfully completed neb 202, neb 302, or neb 305. to enter the 4-week follow-up phase, patients must have completed neb-306 (extension phase) and received only nebivolol monotherapy treatment during neb 306. exclusion criteria: * secondary hypertension * myocardial infarction or stroke * contraindications to beta-blocker therapy

Keywords: nebivolol hypertension beta-blocker
stem cell transplant with or without tbo-filgrastim in treating patients with multiple myeloma or non-hodgkin lymphoma

Conditions: Non-Hodgkin's Lymphoma; Plasma Cell Myeloma

Summary: this phase ii trial studies how well stem cell transplant with or without tbo-filgrastim works in treating patients with multiple myeloma or non-hodgkin lymphoma. eliminating the use of tbo-filgrastim after transplant may still help maintain a similar time to discharge.

primary objective: i. to demonstrate non-inferiority in the number of days to discharge readiness after a granulocyte colony-stimulating factor (g-csf) + plerixafor-mobilized autologous stem cell transplant in patients receiving versus not receiving post-transplant growth factor support. secondary objective: i. to compare days to absolute neutrophil count (anc) \> 500, days to platelet engraftment, febrile days, days of febrile neutropenia, documented infections, and number of antibiotic days in patients receiving versus not receiving post-transplant growth factor support. exploratory objective: i. to evaluate immunological recovery (lymphocyte number including cd 3/4 and cd3/8 t cell subsets) at day + 60 in patients receiving versus not receiving post-transplant growth factor support.

Eligibility criteria:
inclusion criteria: * undergoing autologous stem cell transplant for one of the following diagnoses: * multiple myeloma * non-hodgkin lymphoma * karnofsky performance status of \>= 70% * patients must meet the thomas jefferson university hospital (tjuh) bone marrow transplant (bmt) standard of procedure (sop) guidelines for "patient criteria for autologous hsct" * left ventricular ejection fraction (lvef) of ≥ 40% * adjusted carbon monoxide diffusing capability (dlco) \> 45% of predicted corrected for hemoglobin * serum bilirubin \< 1.8 * aspartate aminotransferase (ast) or alanine aminotransferase (alt) \< 2.5 x upper limit of normal * serum creatinine =\ 40 ml/min (excludes multiple myeloma patients receiving high dose melphalan conditioning) * willingness to use contraception if childbearing potential * has the ability to give informed consent, or for cognitively or decisionally impaired individuals (vulnerable population), the availability of a family member or guardian to give consent and assist in the consent process * life expectancy of \> 12 months (exclusive of the disease for which the auto hsct is being performed) * patients must have undergone stem cell mobilization with the combination of g-csf and plerixafor as per tjuh bmt sop guidelines * collection of an adequate number of cd34+ stem cells, i.e. \>= 4-6 x 10\^6/kg from apheresis exclusion criteria: * uncontrolled human immunodeficiency virus (hiv) * uncontrolled bacterial infection * active central nervous system (cns) disease * pregnancy or lactation * evidence of another malignancy, exclusive of a skin cancer that requires only local treatment
a study to investigate the safety and efficacy of cp-690,550 in patients with moderate to severe crohn's disease

Conditions: Crohn's Disease

Summary: this study investigates safety and efficacy of cp-690,550 in adult patients with moderate to severe crohn's disease. the study hypothesis is that at least one of the dose levels to be tested will be more effective than placebo (inactive drug).


Eligibility criteria:
inclusion criteria: * subjects must be at least 18 years of age at screening * males and females with clinical evidence of crohn's disease for at least 3 months duration at screening * subjects with moderate to severe crohn's disease at baseline, as defined by a crohn's disease activity index (cdai) score of 220-450 inclusive exclusion criteria: * subjects currently receiving immunosuppressants, interferon, anti-tnfa * subjects with evidence of hematopoietic disorders * subjects with evidence of active or latent tb
4-step-training program for social media addiction (4-step-tps) among young adults

Conditions: Social Media Addiction

Summary: the goal of this clinical trial is to develop a comprehensive training program intervention for social media addiction called the 4-step-training program for social media addiction (4-step-tps) and to learn if the 4-step-tps will address and help manage the problems related to social media addiction. other key objectives include the management of dysfunctional patterns, the promotion of positive patterns and healthy lifestyle, and the promotion of daily life activities and productivity. young adult participants will take the 4-week 4-step-tps program with 1 weekly session in either individual or group settings or be placed on a waitlist control.

participants in this research, a sample of n=400 young adults will be initially enrolled for eligibility screening assessment from all over pakistan using purposive sampling techniques. the participants' age range will be 18-30 years having no physical/psychiatric/psychological conditions. n=90 participants after the eligibility assessment and screening will be allocated to experimental and waitlist treatment condition. expected outcomes this study will provide valuable information to the mental health practitioners to treat and develop the guidelines and protocol for young adults with social media addiction. this 4-step-training program will provide understanding and insight to the participants about the problems related to social media addiction. further, this training program will address the dysfunctional patterns associated with social media addiction, including fomo and phubbing, as well as fatigue, insomnia, and psychological distress. moreover, this training program will improve participants' productivity and flourishing while significantly reducing the level of social media addiction.

Eligibility criteria:
inclusion criteria: * age range: 18-30 years * no physical, psychiatric, or psychological conditions * minimum score of 84 on the social networking addiction scale (snas) * minimum score of 60 on the secure flourish index (sfi) exclusion criteria: * age below 18 or above 30 years * presence of any physical, psychiatric, or psychological conditions * score below 84 on the social networking addiction scale (snas) * score below 60 on the secure flourish index (sfi)

Keywords: training program 4-step-training program for social media addiction social media addiction social networking flourishing dysfunctional patterns fatigue assessment scale (fas) intervention
phase iv bioseal study in brain tumor surgery

Conditions: Hemostasis; Meningioma Surgery

Summary: the objective of this study is to observe the clinical utility and performance of bioseal when used as an adjunct to hemostasis versus standard of care (soc) in elective meningioma surgery.


Eligibility criteria:
inclusion criteria: * subjects between 18 and 75 years of age * undergoing elective meningioma surgery and having a tumor cavity * presence of an appropriate target bleeding site (tbs) as identified intra-operatively by the surgeon requiring an adjunct to achieve hemostasis * able and willing to comply with procedures required by protocol * signed and dated written informed consent prior to any study related procedures. exclusion criteria: * subjects undergoing emergency surgery * subjects with any intra-operative findings that may preclude conducting of the study procedures * intended use of fibrin sealants (including autologous fibrin sealants) other than bioseal on the target bleeding site (tbs) * subjects with known intolerance to blood products or to one of the components of the study product or unwilling to receive blood products * subjects who have a history of traumatic head injury * female subjects who are known breastfeeding or pregnant or intend to become pregnant during the clinical study period * the subject, in the opinion of the investigator, would not be suitable for participation in the study * subjects who participated in another trial within 30 days prior to the planned start of treatment.
impact of craniovertebral angle on dizziness and risk of falling in cervical radiculopathy patients

Conditions: Cervical Radiculopathy

Summary: -the goal of this observational study is to learn about the impact of the changes in cranio-vertebral angle on the cervicogenic dizziness and the risk of falling in the patients with cervical radiculopathy .the main question it aims to answer is: is there an impact of the changes in cranio-vertebral angle on the cervicogenic dizziness and the risk of falling in the patients with cervical radiculopathy ? the participants will be undergone measuring the cranio-vertebral angle ,assessment of cervical proprioception and other tasks and questions through 3scales . researchers will compare between study group and control group to see if there isimpact of the changes in cranio-vertebral angle on the cervicogenic dizziness and the risk of falling in the patients with cervical radiculopathy .


Eligibility criteria:
inclusion criteria: * the patients will include if they have the following: 1. fifty patients with chronic cervical radiculopathy(degenerative type) from both sex will participate in the study (twenty five with forward head posture (fhp) , and twenty five without forward head posture (fhp) ). 2. the duration of the disease (cervical radiculopathy)is more than 6 months. 3. the age ranged from 35 to 50 years old. 4. mild to moderate neck pain on visual analogue scale . 5. pain and dizziness lasting for 3-6 months. 6. subjective dizziness experienced in conjunction with cervical pain, movement, stiffness, or particular postures. exclusion criteria: * the patients will exclude if they exhibit any of the following: 1. cervical myelopathy. 2. cervical myelo-radiculopathy. 3. acute cervical radiculopathy. 4. diabetic neuropathy. 5. previous cervical surgery. 6. cervical trauma. 7. deformities in the cervical spine . 8. rheumatoid arthritis. 9. any tumours and infection involving the cervical spine . 10. patients with a history of neuromuscular disorders. 11. precise diagnosis of either central dizziness (due to cerebrovascular disorders related to the vertebrobasilar circulation, migraine, multiple sclerosis, tumours of the posterior fossa, neurodegenerative disorders, some drugs, and psychiatric disorders) or peripheral dizziness( due to a problem in the part of the inner ear that controls balance. these areas are called the vestibular labyrinth, or semicircular canals. the problem may also involve the vestibular nerve. this is the nerve between the inner ear and the brain stem).
the effect of foot reflexology applied on dialysis patients

Conditions: Nursing Caries

Summary: reflexology is massage therapy used to maintain and improve health, as well as relieve some symptoms. foot reflexology, which is thought to have an effect on dialysis symptoms, will be applied to hemodialysis patients in 9 sessions. in this study, it is aimed to determine the effect of foot reflexology applied to dialysis patients on sleep, anxiety and quality of life.

reflexology is defined as a holistic treatment based on stimulating the nerves and blood circulation in the body by manually stimulating the reflex points in the hands and feet corresponding to all parts of the body, organs and systems. in the literature, there are many studies conducted in different samples to evaluate the effectiveness of reflexology massage. hemodialysis patients are also included in these samples. hemodialysis patients are faced with many physical and emotional symptoms such as lifestyle changes, psychosocial effects, side effects due to treatment, during their treatment process. nurses play an important role in alleviating and eliminating these complaints. objective: it is aimed to determine the effect of foot reflexology applied to dialysis patients on sleep, anxiety and quality of life. design: randomized, controlled, prospective study. setting: university hospital hemodialysis center in izmir. patients: forty patients receiving hemodialysis treatment. interventions: nine sessions of reflexology massage will be given to reflex points including the solar plexus, brain, pituitary, thyroid, diaphragm, upper lymphs, lung, spinal cord and adrenal glands. main outcome measures: sleep, anxiety, and quality of life.

Eligibility criteria:
inclusion criteria: * conscious and oriented with no communication problem * agreeing to participate in the study * receiving hemodialysis treatment 3 times a week for 6 months or more * patients who have no problem to apply massage; those who do not have any skin lesions, burns, pathological diseases related to muscles and bones, phlebitis, embolism or bleeding disorder. exclusion criteria: * patients who have received hemodialysis treatment for less than 6 months. * patients with diabetic neuropathy * those who have any skin lesions, burns, open wounds, muscle and bone-related pathological disease, phlebitis, embolism or bleeding disorder in the foot. * patients with infection

Keywords: reflexology dialysis nursing care
in vitro exposure by vr to enhance return to work after sick leave due to stress-related complaints

Conditions: Return to Work; Occupational Stress; Self-Efficacy

Summary: the goal of this pilot randomised controlled trial is to investigate whether in vitro exposure by vr enhances return to work (rtw) in flight cabin crew on sick leave with stress-related complaints. the main research questions are: 1. does vr enhances time to full rtw? 2. does vr increase self-efficacy and positive cognitions regarding rtw, and decrease job anxiety? researchers will compare a control group receiving care as usual as provided by a psychotherapist to an intervention group receiving care as usual plus one session with vr-glasses in which participants are virtually exposed to their workplace.

this study evaluates the effectiveness of in vitro exposure to the workplace by means of vr to improve sustainable rtw among sick-listed flight cabin crew with stress-related complaints compared to usual care. the study design is a pilot randomized controlled trial, including an intervention and control group. sick-listed workers in the control group receive care as usual from a psychotherapist. sick-listed workers in the intervention group receive care as usual from a psychotherapist and participate in a vr-session. during the vr-session, guided by the psychotherapist, participants are virtually exposed to their workplace. data on the primary outcome of (full) rtw is collected based on the company's register data (12 months after baseline). data on secondary outcomes (self-efficacy, cognitions regarding rtw and job anxiety) is collected with baseline and follow-up questionnaires (4 months after baseline).

Eligibility criteria:
inclusion criteria: - sick listed cabin crew with stress-related complaints that are referred by the occupational physician to a specific psychotherapist practice exclusion criteria: * epilepsy * eye condition * no signed informed consent

Keywords: virtual reality return to work pilot randomized controlled trial cabin crew stress return to work self-efficacy job anxiety usability return to work attitude
prazosin treatment for disruptive agitation in alzheimer's disease

Conditions: Alzheimer's Disease

Summary: a study of outpatient participants with alzheimer's disease or a related dementia who have difficult behaviors that are upsetting for them or their caregivers. prazosin is a medication that is commonly used to treat people with high blood pressure. research with prazosin has shown that it may be effective in treating behavioral problems by reducing excess adrenalin effects in the brain.

this is a 24 week study with 14 visits to the research clinic. approximately 6 of these visits may be done by phone. additional phone checks are scheduled at the beginning of each 12 week part of the study. participants will have a 50:50 chance of being on prazosin or placebo in the first 12 weeks of the study. for the second 12 weeks, all participants will take prazosin. study visits include a physical and neurological exam; memory testing; interviews with the caregiver about behaviors; and vital signs.

Eligibility criteria:
inclusion criteria: * no age limit * probable or possible alzheimer's disease * disruptive agitated behaviors at least twice a week (overly anxious or excited, making offensive comments.....) * stable medications for 2 weeks * must have a caregiver who spends 10 hours per week caring for the participant and agrees to participate in all evaluation sessions exclusion criteria: * cardiovascular: unstable angina, recent myocardial infarction, preexisting hypotension (systolic bp less than 110) or orthostatic hypotension (≥20 mmhg drop in systolic bp following 2 minutes of standing posture) * any unstable medical condition * exclusionary medications: current treatment with prazosin, other alpha-1 blockers (trazodone, sildenafil, vardenafil or tadalafil) * psychoactive medications: subjects may be psychoactive medication-free or be partial responders (by subjective assessment of referring health care professional) to one psychoactive medication from any of the following classes: antipsychotics, anticonvulsants, mood stabilizers, antidepressants, benzodiazepines, or buspirone. partial response is defined as some improvement in agitated behavior but persistence of agitated behaviors severe enough to cause patient distress and/or difficulty with caregiving. although not formally rated, this improvement is equivalent to a clinical global impression of change rating of no more than minimal improvement (improvement is noticed by not enough to improve patient function or caregiver's practical management of the patient). * psychiatric/behavioral: lifetime schizophrenia; current delirium, mania, depression, or uncontrolled persistent distressing psychotic symptoms (hallucinations, delusions), substance abuse, panic disorder, or any behavior which poses an immediate danger to patient or others or which results in the patient being too uncooperative to meet the requirements of study participation.

Keywords: double-blind treatment prazosin disruptive behaviors in alzheimer's disease