Kornimate/medical-research-clean huggingface dataset:
proact post-approval study

Conditions: Stress Urinary Incontinence

Summary: the proact post approval study is a 5-year prospective, open-label, multi-center study designed to evaluate the long-term incidence of urethral stricture and device erosion after proact implantation. in addition, the study will evaluate whether treatment with proact affects clinical outcomes after subsequent sui therapies.


Eligibility criteria:
inclusion criteria: 1. subject is a male of at least 50 years of age. 2. subject demonstrates stress urinary incontinence. 3. subject has undergone a radical prostatectomy, transurethral resection of the prostate, or other prostate surgery. 4. subject is willing and able to undergo surgical implantation of proact devices. 5. subject is willing and able to comply with study-required follow-up activities, including annual telephonic follow -up interviews, for a period of 5 years from their date of initial implantation. this includes compliance even after possible explant of proact devices and/or possible implantation of subsequent therapies. 6. subject is willing and able to sign the approved informed consent. 7. subject has two positive 24-hour pad weight tests (greater than or equal to 8 gram pad weight increase demonstrated in two 24-hour pad weight tests). 8. subject has a negative urine culture. 9. subject has no known urogenital malignancy, other than previously treated prostate cancer. 10. subject meets one of the following criteria: 1. baseline prostate-specific antigen (psa) of less than or equal to 2.5ng/ml; 2. baseline psa \> 2.5ng/ml and less than or equal to 10 ng/ml and free psa greater than or equal to 25% of total psa; 11. physician determines subject to be a suitable surgical candidate. exclusion criteria: 1. subject has an existing urethral stricture, a history of any urethral strictures, or has ever had a urethrotomy. 2. subject has undergone prostate surgery or any anti-incontinence surgery within the last 12 months. 3. subject has an artificial urinary sphincter or any components of a previously implanted artificial urinary sphincter in vivo. 4. subject has undergone radiation therapy in the prostatic area within the last 12 months. 5. subject has untreated or unsuccessfully treated detrusor instability or over-activity. 6. subject has an atonic bladder. 7. subject had, presently has, or is suspected of having bladder cancer. 8. subject has untreated or unsuccessfully treated bladder stones. 9. subject has detrusor sphincter dyssynergia. 10. subject has known hemophilia or a bleeding disorder. 11. subject has a known severe contrast solution allergy (e.g., anaphylaxis, cardiac, or respiratory arrest). 12. subject has insulin-dependent diabetes that is uncontrolled or not controllable, as indicated by an a1c test result of = 6.5%.
levator muscle reaction for unilateral congenital ptosis repair as compared to levator plication

Conditions: Congenital Ptosis

Summary: the aim of this study was to compare the outcome of levator muscle resection with plication in mild to moderate congenital unilateral blepharoptosis.

blepharotosis is one of the most encountered oculoplastic problems. blepharoptosis is an abnormal low lying upper eyelid margin more than 2mm below the superior corneal limbus in the primary gaze position. it can be subdivided according to the amount of levator function into poor (0-5),fair (6-11) or good (12 or more) millimeter. it can be classified also according to the degree of ptosis into mild (2mm) moderate (3mm) and severe ( 4mm or more). surgical options for each of these groups are based on levator function as well as the degree and the cause of ptosis.

Eligibility criteria:
inclusion criteria: * mild to moderate simple unilateral congenital ptosis with good to fair levator function exclusion criteria: 1. severe ptosis 2. poor levator function 3. poor bell's phenomenon 4. lagophthalmos 5. diminished corneal sensation 6. completed congenital or acquired ptosis 7. history of previous lid surgery
sfgt for persistent anxiety and depression

Conditions: Depressive Symptoms; Anxiety Disorders; Persistent; Anxiety Depression

Summary: rationale: although there are effective treatments available for anxiety and depression, there is a large group of clients that does not benefit sufficiently from first-choice treatment. for this group of clients, no suitable alternative exists yet. one of the main hypothesis about maintaining factors is that there are underlying personality features that impede recovery. schema focused therapy (sft) is a transdiagnostic therapy focusing on underlying personality features. it has been proven to be an effective therapy for people with personality disorders and there are initial indications that sft is also an effective treatment for anxiety and depressive symptoms. a short-term schema focused group therapy (sfgt) has been developed within ggz-nhn, which is expected to benefit clients with persistent anxiety and depressive symptoms, but has not yet been studied. objective of the study: in the present study the effectiveness of short-term sfgt (protocol of de jager, burger \& groot) on (1) persistent anxiety and depressive symptoms, and (2) early maladaptive schemas (ems), experiential avoidance and the mode of the healthy adult will be investigated.

study design: a single case experimental design (sced), using repeated measures over four different phases.

Eligibility criteria:
inclusion criteria: * persistent anxiety or depression symptoms (at least moderate score at the subscale depression (≥7 or anxiety ≥6 on the dass-21). * history of at least one previous evidence-based therapy focused on anxiety, depression or ptsd according to the dutch national guidelines. * able to comprehend dutch at a level sufficient to complete self-report. exclusion criteria: * clients with severe problems that need to be addressed first, including substance abuse, psychosis, anxiety disorder, ptsd or depression that not have been treated. * start of (or change in) medication which is not yet stabilized at the start of this study. * psychosocial problems such as homelessness, no income or high debts which would make the clients unable to participate in a group.

Keywords: schema therapy group therapy
lipid formulation to increase the bioavailability of fatty acids in cystic fibrosis (cf) patients

Conditions: Cystic Fibrosis

Summary: the purpose of this trial is to evaluate if the use of a newly developed lipid formulation versus fish oil would better enable the absorption of essential fatty acids after 12 weeks of supplementation.


Eligibility criteria:
inclusion criteria: 1. previously diagnosed cf according to established criteria (diagnosis of cf will be based on either two positive sweat chloride tests of \>60 meq/l or the identification of two detectable mutations associated with cf) 2. exocrine pancreatic insufficiency defined by pathological fecal elastase (\<15µg/g) found in the medical history of the patient 3. informed consent letter signed and dated by their parents or legal guardians before inclusion in the study, and assent signed and dated by the child if he or she is ≥ 14 years old exclusion criteria: 1. any change (initiation, change in type of drug, dose modification, schedule modification, interruption, discontinuation, or re-initiation) in a chronic treatment/prophylaxis regimen for cf or for cf-related conditions within 4 weeks prior to baseline 2. exposure to another investigational drug or dietary supplements and enteral nutrition containing epa and docosahexaenoic acid (dha), fish or the use of any other supplement containing fish oil within 4 weeks prior to baseline. 3. treatment with intravenous antibiotics within 4 weeks prior to baseline 4. newly started oral antibiotic treatment within 4 weeks prior to baseline 5. history of solid organ or hematological transplantation 6. ongoing immunosuppressive therapy (other than corticosteroids) within 3 weeks prior to baseline 7. major complications of lung disease (including massive hemoptysis, pneumothorax, or pleural effusion) within 8 weeks prior to baseline 8. evidence of pulmonary exacerbation or acute upper or lower respiratory tract infection (including viral illnesses) within 3 weeks prior to baseline 9. having donated blood or had a transfusion of blood/blood products during the trial and 3 months prior to screening or expected to do so during the study 10. any bleeding disorders at screening 11. patient who cannot be expected to comply with the study procedures. 12. currently participating or having participated in another clinical trial within 8 weeks prior to baseline. 13. any known food allergy 14. incapacity to swallow capsules
amlodipine vs nitrates study in patients with chronic stable angina

Conditions: Myocardial Ischemia

Summary: the objective of study is to compare the anti-ischemic efficacy and safety profiles of once daily amlodipine or isosorbide-5-mononitrate in the treatment of stable asymptomatic and symptomatic myocardial ischemia


Eligibility criteria:
inclusion criteria: * outpatients \> =18 years of age with diagnosed clinically stable angina pectoris exclusion criteria: * patients with congestive heart failure, clinically significant cardiovascular disease, standing systolic blood pressure of less than 100mmhg, concomitant anti-anginal therapies similar to sublingual ntg
study evaluating genotypes using lucentis

Conditions: Age-Related Maculopathy

Summary: the purpose of the study is to investigate whether the efficacy of lucentis treatment for exudative age-related macular degeneration is associated with vegf and htra1 dna polymorphisms

treatment naive exudative amd patients will receive lucentis treatment as standard of care, and followed monthly for 12 months. standard ophthalmologic exams will be performed, along with etdrs visual acuity and optical coherence tomography (oct). a blood sample will be obtained for dna analysis. the primary outcome measure is change in visual acuity at 4 months after initial lucentis treatment. secondary outcomes are change in visual acuity and retinal thickness at 12 months.

Eligibility criteria:
inclusion criteria: * treatment naive amd patients; * at least 50 years of age; * visual acuity between 20/40 and 20/320 exclusion criteria: * pregnancy; * prior enrollment in a ranibizumab clinical trial; * previous therapy in either eye for amd; * concurrent eye disease that could compromise visual acuity

Keywords: exudative age-related macular degeneration
pharmacotherapy follow-up in older hiv-infected patients

Conditions: HIV

Summary: cardiovascular diseases (cvd) are the main cause of death in spain. in hiv patients, the uncontrolled viral replication, antiretroviral therapy (art) and coinfections contribute to develop metabolic diseases and increase the prevalence of risk factors for cvd. these patients are aging which results in a higher probability of comorbidities, increased number of medications, possibility of having a negative outcome associated with medication (nom) and increased cardiovascular risk (cvr). various studies have established that pharmaceutical care (pc) results in better control of cardiovascular risk factors. the purpose of this study is to evaluate the impact of pharmaceutical care achieved through pharmacotherapy follow-up on cardiovascular risk and health related quality of life (hrqol) of hiv patients older than 50.

quasi-experimental clinical study, pre-post intervention, performed with one patient cohort. study will be carry out at a tertiary hospital. the population will be constituted of patients who receive care from the outpatient department of the pharmacy service in use of antiretroviral therapy. variables will be obtained from patients' clinical histories, from dispensing records and through interviews with patients. main variables: * cardiovascular risk estimated according to systematic coronary risk evaluation (score) and registre gironí del cor (regicor) equations * hrqol measured by the short-form 36-item health survey (sf-36) and medical outcomes study hiv health survey (mos-hiv) questionnaires. other variables: sociodemographic, clinical, pharmacological, related to cvr, related to nom and to the interventions. interventions will be performed every two months until complete 12 months of follow-up. pharmacotherapy follow-up will be conducted according to the dader method. the interventions will be health education for lifestyle modification, improve adherence and aimed to the resolution of nom and drug-related problems.

Eligibility criteria:
inclusion criteria: * patients older than 50 years * in use of antiretroviral therapy * cardiovascular risk ≥2%, estimated by the score equation * accept to participate in the research through the signature of a written informed consent exclusion criteria: * patients with neurodegenerative deficit or hiv dementia * participants in clinical trials * non signature of a written informed consent

Keywords: hiv pharmaceutical care older patients cardiovascular risk pharmacotherapy follow up
postoperative pain after pulpectomy of primary molars using different obturation materials

Conditions: Post Operative Pain

Summary: testing postopertive pain after pulpectomy of primary molars with metapex and endoflas using modified wong-baker scale of pain.

the current equivalent parallel randomized controlled trial will be conducted to evaluate intensity and duration of post-operative pain after pulpectomy of asymptomatic necrotic primary molars, using metapex and endoflas obturation materials

Eligibility criteria:
inclusion criteria: * 3.1. inclusion criteria: the study will include children who meet the following clinical and radiographic criteria: clinical: 1. 5-7-year old children categorized as class i or ii according to american society of anaesthesiologists (asa) scale. 2. children rated as no.3 or 4 in frankel behavior rating scale (fbrs). 3. presence of at least one primary molar with deep carious lesion. 4. asymptomatic necrotic molars confirmed by the absence of bleeding on opening of the pulp chamber. radiographic: 1. extensive caries approaching to the pulp. 2. presence of at least two-thirds of root length. exclusion criteria: * a child's tooth with any of the following criteria: clinical findings: 1. history of spontaneous unprovoked toothache. 2. extensive crown destruction that preclude coronal restoration. 3. presence of adjacent or opposing tooth with deep carious lesion "in the same side". 4. history of administering analgesics 12 hours before tooth obturation. radiographic findings: 1. presence of a large furcation or periapical radiolucency approximating the succedaneous tooth. 2. presence of pathological internal/external root resorption. 3. absence of underlying permanent successor.
chemotherapy with or without surgery in treating patients with stage ii or stage iii ovarian cancer

Conditions: Ovarian Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining chemotherapy with surgery may kill more tumor cells. it is not yet known whether chemotherapy plus surgery is more effective than chemotherapy alone in treating patients with stage ii or stage iii ovarian cancer. purpose: randomized phase iii trial to compare the effectiveness of chemotherapy with or without surgery in treating patients with stage ii or stage iii ovarian cancer.

objectives: i. determine the impact of interval debulking surgery, in terms of survival, disease-free survival, and quality of life, in patients with newly diagnosed stage ii or iii ovarian cancer and residual macroscopic disease greater than 1 cm after primary surgery. outline: this is a randomized study of debulking surgery with concurrent chemotherapy. patients are randomized to receive chemotherapy alone (arm i) or chemotherapy and interval debulking surgery (arm ii). arm i: patients receive six courses of platinum-based chemotherapy at intervals of 3 weeks. arm ii: patients receive three courses of platinum-based chemotherapy at intervals of 3 weeks. in the absence of disease progression, patients undergo interval debulking surgery approximately 21 days after initiation of the third course of chemotherapy. surgery is then immediately followed by three additional courses of platinum-based chemotherapy. patients are followed at 6 months after randomization, then every 3 months for the remainder of the first 2 years, then every 6 months for the following 3 years, and then annually thereafter. quality of life is assessed prior to randomization and before the fourth course of chemotherapy, and then at follow-up visits at 6 months and 1, 2, and 3 years. projected accrual: there will be 1,000 patients accrued into this study.

Eligibility criteria:
disease characteristics: histologically confirmed newly diagnosed stage ii or iii ovarian epithelial cancer must be planning to receive platinum-based chemotherapy must be fit for interval debulking surgery residual macroscopic disease with longest dimension of largest tumor mass greater than 1 cm in diameter documented at primary surgery or postoperatively by imaging patient characteristics: age: not specified performance status: not specified life expectancy: not specified hematopoietic: not specified hepatic: not specified renal: not specified other: no concurrent or prior malignancy likely to interfere with protocol treatments or comparison prior concurrent therapy: biologic therapy: not specified chemotherapy: see disease characteristics endocrine therapy: not specified radiotherapy: not specified surgery: see disease characteristics

Keywords: stage ii ovarian epithelial cancer stage iii ovarian epithelial cancer
study to evaluate the effect of filgotinib on semen parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis

Conditions: Rheumatoid Arthritis; Psoriatic Arthritis; Ankylosing Spondylitis; Non-Radiographical Axial Spondyloarthritis

Summary: the primary objective of this study is to evaluate the effect of filgotinib on semen parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis. results of this study may be pooled with the results of a separate study being conducted in participants with inflammatory bowel disease (protocol gs-us-418-4279; nct03201445) with the same objective.


Eligibility criteria:
key inclusion criteria: * diagnosis of active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or, non-radiographic axial spondyloarthritis for at least 12 weeks prior to screening, meeting the corresponding specific disease classification criteria as specified in the protocol key exclusion criteria: * previously documented problems with male reproductive health * prior diagnosis of male infertility * use of any prohibited concomitant medication as outlined by protocol note: other protocol-defined inclusion/exclusion criteria may apply.
pharmacokinetics and safety of ertapenem in the postpartum period

Conditions: Endometritis

Summary: the investigators are doing this study to learn more about the dosing and safety of ertapenem in women with suspected serious infections less than 42 days from the delivery of their infant.

ertapenem has received fda approval for the indication of acute pelvic infection, though there is no pharmacokinetic data to guide dosing of ertapenem in postpartum women. the physiologic changes of the postpartum period make it likely that this special population requires dosing modification to achieve desired therapeutic targets. the objective of this study is to obtain a detailed knowledge of the pharmacokinetics of ertapenem during the postpartum period that will result in improved guidelines on maternal dosing and neonatal exposure. this is a prospective, open-label, single center, pharmacokinetic study of ertapenem in women diagnosed with postpartum endometritis. subjects will include up to 24 women receiving treatment for a diagnosis of postpartum endometritis with ertapenem in the duke university hospital labor \& delivery unit. each patient will participate in the study for approximately 7 days, though the total study duration is expected to be approximately 12 months. descriptive statistics for the subjects will be calculated. the appropriate non-compartmental pharmacokinetic parameters will be computed, including auc24, aucss, cmax, cl, vss, t1/2. all subjects who receive one dose of study drug will be followed for safety, with planned internal review of safety data following the completion of 12 patients. nursing infants of study subjects will also be followed for safety due to the potential for exposure to study drug through breastmilk.

Eligibility criteria:
inclusion criteria: * 18 years of age or older at the time of enrollment. * postpartum period \< 42 days at the time of enrollment. * sufficient venous access to permit administration of study medication. * 2 clinical signs of postpartum endometritis: * oral body temperature of \> 101of at any time, or a temperature of 100.4 on two occasions 6 hours apart. * maternal tachycardia that parallels the temperature. * uterine tenderness * purulent vaginal discharge * findings of advanced endometritis: dynamic ileus, pelvic peritonitis, pelvic abscess, bowel obstruction, necrosis of the lower uterine segment. exclusion criteria: * history of previous hypersensitivity reactions to beta lactams. * receiving valproic acid or divalproex sodium. * creatinine clearance \< 30 ml/min as calculated by the cockroft-gault equation. * subject with a medical condition that, in the opinion of the investigator, would interfere with the pharmacokinetic evaluation of the medication, place the subject at an unacceptable risk of injury, or render the subject unable to meet the requirements of the protocol. * previous participation in the study. * exposure to ertapenem in the week prior to the study