Kornimate/medical-research-clean huggingface dataset:
effect of combined ultrasound-guided subdeltoid corticosteroid injections and physiotherapy in treatment of patients with chronic subacromial bursitis

Conditions: Subacromial Bursitis; Subacromial Impingement Syndrome; Physical Therapy; Therapeutic Exercise; Rehabilitation

Summary: this study is to investigate whether combination of ultrasound-guided subdeltoidcorticosteroid injection and physiotherapy is more effective than either treatment alone in treatment of patients with chronic subacromial (or subdeltoid) bursitis (sab).

chronic subacromial bursitis (sab) is a common shoulder disorder characterized by chronic shoulder pain with a painful arc of motion, and/or pain on active or passive motions. the diagnosis of sab requires confirmation by an infiltration with local anesthetic. previous study showed that corticosteroid injection is more effective than hyaluronic acid in treatment of chronic sab, however, some (about 20%) patients were not responsive to corticosteroid injection, and some responsive patients may have recurrence of symptoms. the purpose of this study is to investigate whether combination of corticosteroids sasd injections and physiotherapy is more effective than either treatment alone in chronic sab.

Eligibility criteria:
inclusion criteria: 1. shoulder pain for more than 1 month 2. age ≥20 years old 3. painful abduction or internal rotation with a visual analog scale (vas) pain score ≥4 4. the presence of a painful arc of motion or pain at the middle to terminal range of shoulder abduction or internal rotation with an empty or soft end feel 5. positive shoulder impingement test (neer test and/or hawkin test) 6. a reduction in pain of ≥40% on active shoulder abduction or internal rotation at the terminal range after injection of 3ml of 1%lidocain into the sasd bursa under us guidance. exclusion criteria: 1. a history of uncontrolled chronic diseases, e.g., malignant neoplasms, blood dyscrasia, and serious infection 2. previous surgery of the affected shoulder 3. any evidence of a rotator cuff tear or tendinopathy, demonstrated by positive resistive tests andsonographic findings 4. calcification of the rotator cuff, demonstrated by x-ray or sonographic findings 5. the presence of arthritis, such asinflammatory arthritis(e.g., rheumatoid arthritis, seronegativespondyloarthropathy, or crystal-related arthropathy), osteoarthritis, frozen shoulder, subacromial spurs, or deformity of the acromion 6. the presence of instability of the affected shoulder 7. a previous fracture near the shoulder region 8. the presence of cervical radiculopathy or myelopathy 9. having received a corticosteroid or hyaluronic acid subacromial or shoulder joint injection in the past 3 months.

Keywords: subacromial bursitis subacromial impingement syndrome corticosteroid physical therapy therapeutic exercise rehabilitation
pd-1 alone or with dendritic cell/renal cell carcinoma fusion cell vaccine

Conditions: Renal Cell Carcinoma

Summary: ct-011 is an investigational monoclonal antibody. monoclonal antibodies are a type of drug that are known to target specific cells (in this case, cells in the immune system) the dc rcc vaccine is agent that tries to help the immune system to recognize and fight against cancer cells. the purpose of this research study is to determine the safety of ct-011 alone, and in combination with the dendritic cell renal cell carcinoma (dc rcc) vaccine. the investigators are also trying to find out what effect the combination has on the disease, and on your immune system.

this study is divided into 2 groups. the first 22 subjects will be in group 1 and will receive ct-011 only. the next 22 subjects will be in group 2 and will receive ct-011 and the dc rcc vaccine. group 1: subjects in this cohort are not required to have tumor resection (nephrectomy) to participate in this study. for subjects who are undergoing nephrectomy and for subjects undergoing resection for another metastasis, infusions of ct-011 will begin 21 to 35 days post-surgery. subjects will receive 4 cycles of ct-011 therapy. each cycle consists of a dose of ct-011 given on days 1, 14, and 28 intravenously. for subjects who are not undergoing nephrectomy for standard of care therapy, infusions of ct-011 will begin 21 to 28 days following registration on the study. subjects will receive a total of four cycles of ct-011 therapy. each cycle consists of a dose of ct-011 given on days 1, 14, and 28 intravenously. group 2: subjects in this cohort will have chosen to undergo a "debulking nephrectomy" (surgery to remove a tumor of the kidney, but not all of the cancer cells in your body) as a standard treatment for kidney cancer or have tumor lesions that are accessible (may be removed without major surgery) and are being removed to treat or diagnose their cancer. all subjects in this group will receive infusions of ct-011 21 to 35 days following tumor resection. subjects will receive a total of 4 cycles of ct-011 therapy. each cycle consists of a dose of ct-011 given on days 1, 14, and 28. in addition they will receive a vaccination of the dc rcc vaccine on day 8 of each cycle.

Eligibility criteria:
inclusion criteria: * stage iv renal cancer * measurable disease * life expectancy \> 3 months * adequate organ and marrow function exclusion criteria: * clinical evidence of central nervous system (cns) disease. subjects with a history of treated brain metastasis must be stable with no evidence of disease for 3 months * clinically significant autoimmune disease * hiv+ * serious intercurrent illness such as infection requiring intravenous (iv) antibiotics, or significant cardiac disease characterized by significant arrhythmia, uncontrolled hypertension, unstable ischemic coronary disease or congestive heart failure * pregnant or lactating * history of clinically significant venous thromboembolism (for cohort 2)

Keywords: kidney metastatic stage iv
assessment of treatment success and quality of life in patients with actinic keratoses under therapy with ingenol mebutate in a period of 8 weeks

Conditions: Actinic Keratosis

Summary: assessment of treatment success and quality of life in patients with actinic keratoses under therapy with ingenol mebutate (picato) in a period of 8 weeks.

non-interventional (observational) study (nis), non-controlled, prospective cohort study.

Eligibility criteria:
inclusion criteria: • non-hyperkeratotic, non-hypertrophic actinic keratoses where treatment with picato® is indicated and the treatment is intended by physicians. exclusion criteria: * preceding use of picato® on the area planned for treatment * any other specific local treatment of actinic keratoses on the area planned for treatment during the last 8 weeks * melanoma, squamous cell carcinoma or spinalioma on the area planned for treatment * open wounds on the area planned for treatment * contraindications according to prescribing information

Keywords: actinic keratosis
post-marketing study of cilostazol (cilostazol stroke prevention study 2)

Conditions: Cerebral Infarction

Summary: the purpose of this study is to investigate the efficacy of cilostazol in preventing recurrence of cerebral infarction and the safety of long-term administration of the drug (100 mg, twice daily) in patients with cerebral infarction (excluding cardiogenic cerebral embolism) in a multi-center, double-blind, parallel-group comparison with aspirin (81 mg, once daily).


Eligibility criteria:
inclusion criteria: 1. patients with stable medical conditions for 182 days (26 weeks) after occurrence of cerebral infarction 2. patients in whom the infarct-related foci was detected by x-ray ct scan or mri 3. patients aged 20 to 80 years (inclusive) at time of consent 4. patients with none of the following cardiac diseases that may be associated with cardiogenic cerebral embolism: mitral stenosis, prosthetic heart valve, endocarditis, myocardial infarction within 6 weeks after occurrence, ventricular aneurysm, endocardial thrombosis, mitral valve prolapse (patients less than 45 years of age in whom no other cause was identified), atrial fibrillation, sick sinus syndrome, idiopathic cardiomyopathy, and patent foramen ovale 5. patients without asymptomatic cerebral infarction 6. patients who have neither undergone nor are scheduled to undergo percutaneous transluminal angioplasty or revascularization for the treatment of cerebral infarction 7. patients without severe disturbances/impairments following occurrence of cerebral exclusion criteria: 1. patients with hemorrhage or bleeding tendency (hemophilia, capillary fragility, intracranial hemorrhage, hemorrhage in the digestive tract, hemorrhage in the urinary tract, hemoptysis, and hemorrhage in the vitreous body) 2. pregnant, possibly pregnant, or nursing women 3. patients with ischemic heart failure 4. patients with peptic ulcer 5. patients with severer blood disorders 6. patients with severe hepatic or renal 7. patients with malignant neoplasm or patients who have received any therapy for malignant neoplasm within 5 years prior to entering the study 8. patients with a history of hypersensitivity to salicylic acid formulations or ingredients of cilostazol tablets 9. patients with aspirin asthma (asthma attacks induced by nonsteroidal antiinflammatory analgesic agents) or a history of aspirin asthma 10. patients who are being treated with ticlopidine hydrochloride 11. patients who are participating in another study for an investigational drug 12. patients who are otherwise judged inappropriate for inclusion in the study by the investigators
a study of mirikizumab (ly3074828) in participants with moderate to severe ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the main purpose of this study is to test the hypothesis that treatment with mirikizumab is superior to placebo in providing clinical benefit to participants with moderate to severe ulcerative colitis (uc). this study will also investigate how the body processes the drug.


Eligibility criteria:
inclusion criteria: * have moderate to severe active uc as defined by a mayo score of 6 to 12 with an endoscopic subscore ≥2 within 14 days before the first dose of study treatment (note: a partial mayo score of at least 4 and other eligibility criteria must have been met before endoscopy is performed as a study procedure) * have evidence of uc extending proximal to the rectum (≥15 centimeters \[cm\] of involved colon) * up-to-date colorectal cancer surveillance (performed according to local standard), for subjects with family history of colorectal cancer, personal history of increased colorectal cancer risk, age \>50 years, or other known risk factor * participants must either: be naive to biologic therapy (eg, tumor necrosis factor \[tnf\] antagonists or vedolizumab) and have at least 1 of the following: inadequate response or failure to tolerate current treatment with oral or intravenous corticosteroids or immunomodulators (6-mercaptopurine or azathioprine) or history of corticosteroid dependence (an inability to successfully taper corticosteroids without return of uc) or have received treatment with 1 or more biologic agents (eg, tnf antagonists or vedolizumab) at doses approved for the treatment of uc with documented history of failure to respond to or tolerate such treatment exclusion criteria: * have been diagnosed with indeterminate colitis, proctitis (distal disease involving the rectum only; less than 15 cm from the anal verge) or crohn's disease * have had surgery for treatment of uc or are likely to require surgery for uc during the study * have received any of the following for treatment of uc: cyclosporine or thalidomide within 30 days of screening, corticosteroid enemas, corticosteroid suppositories, or topical treatment with 5-aminosalicyclic acid within 30 days of screening

Keywords: il-23 antibody
tranexamic acid versus vaginal misoprostol in abdominal myomectomy

Conditions: Myomectomy

Summary: the aim of the present study is to evaluate safety and efficacy of tranexamic acid versus vaginal misoprostol in reducing intraoperative blood loss during abdominal myomectomy


Eligibility criteria:
inclusion criteria: * symptomatic fibroids candidate for abdominal myomectomy exclusion criteria: * myomas candidate for laparoscopic or hysteroscopic myomectomy and allergy or contraindications to misoprostol or tranexamic acid
a study to determine the flow changes and/or ahi reduction when stimulating two targets (neural and/or muscular) for the treatment of obstructive sleep apnea in adult subjects

Conditions: Sleep Apnea; Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Sleep Disorder

Summary: this proof-of-concept study will collect acute and sub-acute flow and/or ahi data following the placement of lead arrays under direct vision. the acute placement and data collection will be collected following the completion of the pre-scheduled neck dissection surgery. the sub-acute data will be collected in a sleep lab during a polysomnography (psg). both data collections will be done when stimulating (using an external pulse generator) the hypoglossal nerve or genioglossus muscle (gg) and a second neural target (ansa cervicalis - ac) or the strap muscles (sternohyoid and sternothyroid) with a set of off-the-shelf (ots) electrode arrays.


Eligibility criteria:
inclusion criteria: a patient must meet all of the following inclusion criteria to be eligible for inclusion in this study: * age above 18 years not under guardianship, under curatorship or under judicial protection. * body mass index (bmi) \< 38 kg/m2. * subject must be eligible for neck dissection surgery. * written informed consent obtained from the patient prior to performing any study specific procedure. * willing and capable to comply with all study requirements, including specific lifestyle considerations, evaluation procedures and questionnaires for the whole duration of the trial. exclusion criteria: patients meeting any of the following criteria will be excluded from participation in this study: * major anatomical or functional abnormalities that would impair the ability of the electrode arrays to be positioned. * significant comorbidities that contraindicate surgery or general anesthesia. * significant tongue weakness. * aerodigestive tract tumor or reconstructive surgery performed at the same time as neck dissection. * any other chronic medical illness or condition that contraindicates a surgical procedure or general anesthesia in the judgment of the investigator. * prior surgery or treatments that could compromise the placement and effectiveness of the electrode array systems: * airway cancer surgery or radiation, or * mandible or maxilla surgery in the previous 3 years (not counting dental treatments). * other upper airway surgery to remove obstructions related to osa in the previous 3 months (e.g., uvulopalatopharyngoplasty (uppp), tonsillectomy, nasal airway surgery). * prior hypoglossal nerve stimulation device implantation. * currently pregnant or breastfeeding during the study period. * concomitant oral or pharyngeal surgery.

Keywords: sleep apnea device
innovation in the treatment of persistent pain in adults with nf1: implementation of the icancope mobile application- clinical trial

Conditions: Neurofibromatosis 1; Chronic Pain

Summary: to demonstrate the initial feasibility and determine preliminary impact on clinical outcomes of the icancope-nf program in a pilot rct. if successful this pilot study will support conducting a larger randomized control trial (rct). the primary research question is what is the feasibility of the icancope-nf program? the investigators define feasibility as (1) rates of accrual and dropout, daily log-ins, engagement, and outcome measures completed and (2) perceptions regarding intervention acceptability and satisfaction; and what are the levels of engagement. log-ins, with the intervention? the secondary questions are: (1) how does the icancope-nf program compare with the control condition in differences of pain and pain-related activity limitations, sleep functioning, emotional functioning (depression, anxiety), opioid usage, pain catastrophizing, self-efficacy, respondent burden (i.e. physical functioning, r, vitality, social functioning, role-emotional, and mental health), and psychological flexibility immediately post-treatment (t2), (2) does the icancope-nf + cm increase the engagement of the icancope-nf program as compared to icancope-nf without cm, and do their corresponding levels of pain and pain-related activity decrease with cm?, and (3) do individuals with nf1 utilize the mindfulness based alternative approaches (mbaa) to help reduce pain symptoms? the investigators hypothesize that by customizing and including mbaa to the program for adults with nf1, that individuals who engage regularly as seen through analytics platform for evaluating effective engagement (apeee) application, will acquire new sets of skills to facilitate pain management, while pain as reported with the brief pain inventory will decrease.


Eligibility criteria:
inclusion criteria: * adults 18+ * able to read and understand english at 5th grade level * permanently reside in the united states * have pain interference aggregate scores of three or more in the last two weeks using the brief pain inventory-short form (bpi-sf) scale exclusion criteria: * have an undiagnosed case of nf1 * have documented major co-occurring psychiatric disease * have moderate to severe cognitive deficits * have depression assessed using the patient health questionnaire (phq-9) or anxiety assessed using the generalized anxiety disorder scale (gad-7) greater than or equal to the appropriate thresholds (10=mild major depression; 5=mild severe anxiety)
critical time intervention in the transition from hospital to community in people with severe mental illness

Conditions: Psychotic Disorders

Summary: this study will evaluate the effectiveness of a psychosocial treatment, critical time intervention, in easing the transition from hospital to community in people with severe mental disorders.

severe mental illness (smi) encompasses a wide range of mental disorders and disabilities, but commonly includes disorders that involve symptoms of psychosis. psychotic symptoms may involve hallucinations, a lost sense of reality, or other distressing symptoms. about 6% of people experiencing psychotic symptoms seek inpatient treatment at a psychiatric hospital. hospital treatment for a person with smi often focuses on rapid improvement of negative symptoms and promotion of the necessary skills to successfully return to the community after leaving the hospital. despite preparation for community integration, the transition from hospital to community remains a difficult time for many people with smis, with those affected having an increased chance for suicide, homelessness, and relapse. critical time intervention (cti), a psychosocial treatment program that aims to restore skills for community living and to assist in seeking service and support in the community, may be more effective than usual care in preventing these adverse outcomes after hospital discharge. this study will compare the effectiveness of cti versus usual services in preventing homelessness and other adverse outcomes after leaving a psychiatric hospital among people with smi and psychosis. participation in this study will last 18 months. potential participants will undergo an initial 15- to 30-minute interview that will include questions about current mental, physical, and living conditions; history of psychiatric services; and alcohol and drug use. eligible participants will then undergo the first full interview, which will include a full review of medical records and will last between 2 and 3 hours. after this interview, participants will be assigned randomly to receive cti or usual services. for participants assigned to cti, a cti specialist will visit participants in the hospital and in their homes and will stay in contact with participants for 9 months after hospital discharge. during visits with the cti specialist, participants will receive training in community living skills and help finding service and support in the community. participants assigned to usual services will receive the usual care and community services offered to people recently leaving a psychiatric hospital. after leaving the hospital, participants in both groups will be asked to participate in 15 follow-up interviews, which will include repeat questions from the 2 initial interviews. interviews will be conducted once every 6 weeks until 18 months after hospital discharge and will last between 60 and 90 minutes.

Eligibility criteria:
inclusion criteria: * diagnosis of psychosis * homelessness during the 18 months before study entry * english speaking

Keywords: psychosis homelessness case management severe mental illness
characteristics and management of postmenopausal women with osteoporosis treated with prolia® in france

Conditions: Post Menopausal Osteoporosis

Summary: the purpose of the study is to describe the characteristics and management of post menopausal women with osteoporosis treated with prolia in france, and examine the use of prolia in routine clinical practice in france

this is a multicenter, observational and non-interventional study in pmo patients who receive prolia® (60 mg subcutaneous \[sc\]) in france. patients in the study will be enrolled in 2 waves, each targeting specific aspects of the overall study objectives. the first wave will enroll approximately 500 patients who will be followed for approximately 30 months from the first injection. patients enrolled in this wave will provide descriptive data on persistence to prolia® as well as a description of the characteristics of patients being prescribed prolia®, information regarding prolia® prescription and administration, procedures pertaining to prolia® and safety. the second wave will enroll approximately 250 patients and will only provide a cross-sectional description of the characteristics of patients being prescribed prolia. around 2000 specialists in rheumatology and 9000 general practitioners will be randomly selected from a list of rheumatologists whether in hospital or private practice nationwide and a list of general practitioners managing patients with osteoporosis. in all, 300 physicians initially interested to participate are expected, from which about 180 physicians will be qualified to participate. one-hundred and ten physicians will be initiated. there are no procedures or changes to the routine clinical management of patients participating in the study. baseline characteristics will be described for patients enrolling in both waves 1 and 2. patients enrolling in wave 1 will be followed for approximately 30 months from the date of first injection in the study. it is anticipated that patients will return to the site. clinical information obtained for routine clinical practice will be recorded where available, including prolia administration, previous and current therapies, medical history (including fracture), adrs, sadrs and co-morbidities.the study is descriptive in nature, and no formal hypothesis will be tested. in general, data summaries will be presented by wave and by subgroups of interest.

Eligibility criteria:
inclusion criteria: * post menopausal osteoporosis women in whom a decision has been made to treat with prolia in the last 4 weeks * received their first prescription of prolia in the last 4 weeks * patient has provided informed consent before enrolling in the study exclusion criteria: * patients participating in ongoing or previous denosumab clinical trials

Keywords: osteoporosis post menopausal women