Kornimate/medical-research-clean huggingface dataset:
calcitriol, mitoxantrone, and prednisone in treating patients with metastatic prostate cancer

Conditions: Prostate Cancer

Summary: rationale: calcitriol may cause prostate cancer cells to look more like normal cells, and to grow and spread more slowly. drugs used in chemotherapy, such as mitoxantrone and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. purpose: this phase ii trial is studying how well giving calcitriol together with mitoxantrone and prednisone works in treating patients with metastatic prostate cancer.

objectives: primary * determine the prostate-specific antigen (psa) response rate, defined as the fraction of patients with 50% reduction in psa level over 3 weeks' time, in patients with androgen-independent metastatic prostate cancer treated with high-dose pulse calcitriol, mitoxantrone, and prednisone. secondary * determine the safety and tolerability of this regimen in these patients. outline: this is a multicenter study. patients receive oral high dose pulse calcitriol on day 1, mitoxantrone iv on day 2, and oral prednisone on days 1-21. treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. after completion of study treatment, patients are followed periodically. projected accrual: a total of 48 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed prostate cancer * androgen-independent disease, defined as disease progression while on standard hormonal management, including antiandrogen withdrawal * patients must continue primary hormonal therapy during study treatment * regional or distant metastases * prostate-specific antigen \> 5 ng/ml * no brain metastases patient characteristics: age * 18 to 100 performance status * ecog 0-3 life expectancy * not specified hematopoietic * adequate hematologic function hepatic * adequate hepatic function renal * adequate renal function * no calcium-salt kidney stones within the past 5 years * no hypercalcemia cardiovascular * adequate cardiac function * no significant cardiac disease * no atrial fibrillation other * fertile patients must use effective barrier contraception during and for 2 months after completion of study treatment * no other serious medical illness * no other active malignancy except nonmelanoma skin cancer prior concurrent therapy: biologic therapy * more than 28 days since prior biologic therapy chemotherapy * no prior chemotherapy endocrine therapy * see disease characteristics radiotherapy * no prior strontium chloride sr 89 * more than 28 days since prior radiotherapy * more than 56 days since prior samarium sm 153 lexidronam pentasodium surgery * prior prostatectomy and/or orchiectomy allowed other * more than 28 days since prior investigational therapy

Keywords: recurrent prostate cancer stage iv prostate cancer
natural history observational study of mps iiia in smc

Conditions: Sanfilippo Syndrome A

Summary: to characterize the clinical course of mucopolysaccharidosis type iiia (mps iiia), and identify potential endpoints for future treatment trials.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of mps iiia * has the ability to comply with protocol requirements, in the opinion of the investigator exclusion criteria: * patient's assent is unattainable, or the patient's parent(s), or patient's legally authorized representative(s) is/are unable to understand the nature, scope, and possible consequences of the study, or do/does not agree to comply with the protocol defined schedule of assessments.
ondansetron and gabapentin in preventing postoperative nausea and vomiting after laparoscopic sleeve gastrectomy

Conditions: Post Operative Nausea and Vomiting; Sleeve Gastrectomy; Morbid Obesity

Summary: the aim of this study is to compare the possible efficacy of ondansetron and gabapentin on postoperative nausea and vomiting in patient with morbid obesity who will undergo laparoscopic sleeve gastrectomy.

this study will be a double blind randomized, controlled, parallel, study. a total of1 00 morbidly obese patients who will be scheduled for sleeve gastrectomy will be included in the study. the patients will be selected from those attending gastrointestinal and laparoscopic surgery unit, general surgery department, tanta university hospital, tanta, egypt. the participants will be randomized into two groups by closed envelop method,

Eligibility criteria:
inclusion criteria: * both male and female patients will be included. * morbidly obese patients scheduled for sleeve gastrectomy with bmi ≥35 kg/m2 with the presence of comorbidity such as hypertension, arthritis, and diabetes. * morbidly obese patients scheduled for sleeve gastrectomy with bmi ≥ 40 kg/m2 without comorbidity. * patients fit for anesthesia and surgery. exclusion criteria: * - patients with bmi \>55 kg/m2. * patients with previous procedures for the treatment of obesity. * pregnant females and lactating women. * patients with psychological or psychiatric disease * administration of antiemetic medication or systemic corticosteroids within 24 hours before surgery * patients who experienced vomiting within 24 hours before surgery. * patients with history of alcohol or drug abuse. * patients with hypersensitivity or contraindications to any of the drugs used in this study.

Keywords: postoperative nausea and vomiting laparoscopic sleeve gastrectomy ondansetron gabapentine
regenerative surgical treatment of peri-implant defects

Conditions: Implant Site Pocket Infection

Summary: does submerged healing of implants improve clinical and radiologic outcomes for the treatment of peri-implantitis? a number of recent systematic reviews have shown that the prevalence of periimplantitisin the population is high. nevertheless, there appears to be no consensus on treatment standards for the management of peri-implant diseases. also, the significant variation in the empirical use of the available therapeutic modalities seems to result in moderately effective treatment outcomes. animal and human case series-studies have shown improved outcomes when using a submerged healing approach. however, there seems to be no randomized controlled clinical studies comparing submerged/non-submerged healing efficacy for the treatment of peri-implantitis. since current modalities for the treatment of peri-implantitis seem to result inmoderately effective outcomes, there is an urgency to investigate treatment strategies that will result in improved patient's benefits in terms of health.

the present study will be double-blinded randomized controlled clinical trial. patients requiring surgical treatment of peri-implantitis after non-surgical therapy will beassigned to either: test group: submerged healing or control group: non-submerged healing treatment of peri-implantitis using guided bone regeneration with a bone substitute and a resorbable membrane. the primary aim of this study is to evaluate whether submerged healing of implants willsignificantly improve the changes in marginal bone levels measured on x-rays 12months post-treatment compared to a non-submerged healing approach for the treatment of peri-implantitis. secondary aims include changes in clinical attachment levels, changes in probing pocket depth, recession, keratinized tissue, occurrence of bleeding on probing, suppuration on probing (pus), marginal gingival recession (rec), full mouth plaque score (fmps), full mouth bleeding score (fmbs), type of peri-implant bone defect, frequency and type of complications and implant loss.

Eligibility criteria:
inclusion criteria: * age ≥18 years. * systemically healthy patients. * presence of at least 1 implant diagnosed with peri-implantitis (peri-implant probing pocket depth ≥6 mm in at least 1 aspect of the implant with bleeding and/or suppuration on probing and radiographically documented marginal bone loss ≥3mm) according to renvert et al. (2018), after non-surgical therapy of periimplantitis, and a 4mm deep intrabony component. * absence of mobility of the implants. * individual implant-supported crown or partial fixed implant supported restoration (removable prosthesis will be excluded). * patient's smoking ≤ 10 cigarettes/day. exclusion criteria: * non-removable prostheses
assessing the clinical performance of two frequent replacement silicone hydrogel multifocal contact lenses

Conditions: Presbyopia

Summary: the purpose of this clinical trial is to assess the clinical performance of lid223194 multifocal (mf) contact lenses and commercially available air optix plus hydraglyde (aohg) mf contact lenses. eligible subjects will wear each study lens type in a cross-over fashion as randomized for approximately 2 days.

subjects will be expected to attend 3 scheduled visits for an individual duration of participation of up to 10 days.

Eligibility criteria:
key inclusion criteria: * able to understand and sign an consent form (icf) that has been approved by an institutional review board (irb); * willing to stop wearing habitual contact lenses for the duration of study participation; * currently wearing multifocal soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months; * other protocol-defined inclusion criteria may apply. key exclusion criteria: * any eye infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the investigator; * any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator; * history of refractive surgery, or plan to have refractive surgery during the study; * current or history of dry eye in either eye that would preclude contact lens wear, in the opinion of the investigator; * monovision contact lens wear; * other protocol-defined exclusion criteria may apply.

Keywords: contact lenses
telehealth psychotherapy for depression in parkinson's disease

Conditions: Depression; Parkinson's Disease

Summary: depression is a prevalent non-motor symptom of parkinson's disease (pd). cognitive-behavioral therapy (cbt) has been shown to be an effective treatment for depression in pd. cbt is usually administered in-person in weekly sessions, but pd motor disability, stigma, and transportation issues may prevent attending such therapy sessions. cbt administered via live videoconference technology may allow the treatment of depression, while circumventing the barriers that deter those with pd from seeking psychological services. the investigators propose that videoconference cbt will improve mood in individuals with pd who have depression.

the investigators plan to conduct a randomized control trial with 12 participants. six (pd-early) will receive three assessments: baseline, immediately post-treatment (post1), and 6 weeks after treatment (post2). the other six (pd-waitlist) will have an additional assessment (baseline 2; 12 weeks after baseline 1) to examine practice effects before beginning treatment, and then will have the post1 and post2 assessments (four assessments).

Eligibility criteria:
inclusion criteria: * idiopathic parkinson's disease (pd), any subtype * depression * internet access and a webcam * for psychotropic and dopaminergic medications, participants may enroll only if they are stable for at least 6 weeks and 2 weeks, respectively, before beginning the study * the investigators will enroll only depressed individuals with pd who are not already receiving or are willing to stop other ongoing psychotherapy before beginning this treatment study exclusion criteria: * serious chronic medical or neurological illness, other than pd * history of traumatic brain injury * mental retardation * current or recent (past 90 days) history of substance abuse or drug dependence, with the exception of nicotine, marijuana, and caffeine * active suicidal or homicidal ideation or intent * dementia * current dsm-5 diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or substance/medication-induced disorder * previous experience with an adequate trial of cognitive-behavioral therapy (8 sessions within the past 5 years * concurrent psychosocial treatment (i.e., therapy) focused on depression, anxiety, or other related disorders, or are not willing to refrain from initiating additional therapy during the study * concurrent psychotropic medications if not stabilized or not willing to maintain a stable dosage of psychotropic medications, such as medications for depression or anxiety, during study participation
prevention of wound complications after cesarean delivery in obese women utilizing negative pressure wound therapy

Conditions: Surgical Wound Dehiscence; Wound Infection

Summary: wound complications after cesarean section (c-section) are common in obese women. approximately 25% of obese women having a c-section will have a wound complication. this research study is designed to assess whether applying a source of vacuum (suction) to the wound can reduce the risk of wound complications. the investigators plan to enroll 220 women into the study. women will be randomly selected to receive standard stitching and stapling of the incision (cut on the abdomen) or closure with stitches, staples and wound suction. subjects will be seen for follow-up visits in 7-14 days and again at 4-6 weeks after surgery. the number of wound complications in each group will be compared. if the wound suction technique is successful in preventing wound complications, this may substantially reduce pain and suffering in a large number of women undergoing c-section for delivery.


Eligibility criteria:
inclusion criteria: 1. undergoing cesarean delivery. 2. patient at least 18 years of age. 3. weight greater than 199 pounds. 4. depth of subcutaneous tissue (measured from fascia to epidermis) of greater than or equal to 4 centimeters. exclusion criteria: 1. weight less or equal to 199 pounds or less than 4 cm of subcutaneous tissue present. 2. inability to give proper informed consent. 3. inability to adhere to follow-up provisions of the study (return for 2 post-operative visits at 7-14 days post-op and between 4-6 weeks post-op). 4. patient less than 18 years of age.

Keywords: surgical wound dehiscence wound infection obesity cesarean delivery wound closure negative pressure wound closure
real-time computer aided detection of barrett's neoplasia

Conditions: Barrett Esophagus; Barrett Adenocarcinoma

Summary: in the real-time pilot study, the performance of a recently developed computer aided detection (cade) system will be investigated in 30 patients during real-time live endoscopic examination. three expert endoscopists in the field of barrett's esophagus and endoscopic resection techniques will perform the inclusions following a standardized data acquisition protocol. in total, 15 patients with a visible neoplastic lesion in their barrett's esophagus and 15 patients without any visible abnormalities in their barrett's esophagus will be included in this study. outcomes: to investigate feasibility of the use of the cade system in the endoscopy suite, to investigate the performance of the cade system when used by endoscopists.

patients in this study will undergo a scheduled surveillance endoscopy (according to current guidelines; n = 15) or are referred to a tertiary referral center for endoscopic resection of a possible neoplastic area in their known barrett's esophagus (n = 15). patients will be consciously sedated (standard care) before start of the procedure. during the endoscopic procedure, the endoscopist follows the standard protocol after extensive cleaning of the barrett's segment: first, a standardized pullback video will be recorded, followed by a careful inspection of the barrett segment every 2 centimeters. per 2cm, a video of 10 seconds and 3 overview images are being recorded. during the imaging protocol, the cade system presents its prediction on a second screen, next to the main endoscopy monitor. after the imaging protocol, standard clinical care is being resumed.

Eligibility criteria:
inclusion criteria: * age \> 18 years; * patients under surveillance for their diagnosed non-dysplastic barrett's esophagus or patients refered for endoscopic treatment because of proven high-grade dysplasia or adenocarcinoma; * a circumferential barrett length of at least 2cm exclusion criteria: * medical history of prior surgical or endoscopical treatment for neoplasia in their esophagus * reflux esophagitis \> grade 2 (la classification) * inability to undergo endoscopic treatment and/or biopsies

Keywords: barrett's esophagus computer aided detection
cytochrome p450 pharmacokinetic ddis among patients with chronic low back pain taking opioids

Conditions: Chronic Low Back Pain

Summary: using a retrospective analysis of a large commercial claims database and a medicare database, the investigators evaluated ddes that have the potential to cause ddis among chronic low back pain (clbp) patients on long-term opioid analgesia, which metabolizes through the cyp450 enzyme system, concomitant with other cyp450-metabolized drug(s)


Eligibility criteria:
inclusion criteria: * chronic low back pain exclusion criteria: * pregnancy

Keywords: retrospective chronic low back pain
phenotyping diabetic retinopathy

Conditions: Diabetic Retinopathy

Summary: the purpose of this study is to validate and characterize phenotypes of diabetic retinopathy (dr) progression based on available clinical data (demographic, systemic and ophthalmic data).

this study aims to validate and characterize phenotypes of diabetic retinopathy (dr) progression using ophthalmic and systemic data from type-2 diabetic subjects followed at the aibili clinical trial center in the last 10 years. macular edema (me) development during the study period, mainly clinically significant me (csme) needing treatment, will be the primary indicator for dr progression. csme will be considered as the primary end-point and will be used to identify phenotypes (and risk markers) of dr progression.

Eligibility criteria:
inclusion criteria: * diagnosis of dr. * females or males; * age over 18 years; * signed informed consent; * previous follow-up with regular systemic and ophthalmic assessments. exclusion criteria: * cataract or other eye disease that may interfere with fundus examinations; * vitreous syneresis or posterior vitreous detachment; * dilatation of the pupil \< 5 mm.
nitrofurantoin and urinary tract infections (utis)

Conditions: Urinary Tract Infections

Summary: urinary tract infection (uti) is the most common complication after surgery for prolapse or urinary incontinence. utis are painful and have the potential to turn into kidney infections. we are asking women who self-catheterize after surgery to try either an antibiotic or a placebo pill so we can see if we can prevent utis without causing side effects. this study will not require any additional visits or blood draws. you will be asked to answer some questions, keep a brief diary of your experience, and immediately report any symptoms of a uti to your doctor.

abstract: specific aim: to determine if extended release nitrofurantoin antibiotic prophylaxis administered to patients performing clean intermittent self-catheterization (cisc) after pelvic organ prolapse and/or urinary incontinence surgery decreases the incidence of symptomatic urinary tract infection (uti) compared with placebo. study design: randomized double-blind placebo-controlled trial. methods: consented patients who undergo urogenital surgery and fail their post-operative voiding trial will be randomized to either extended release nitrofurantoin 100mg or an identical appearing placebo capsule to be taken daily while performing cisc and for three subsequent days after stopping cisc. catheterized urine specimens will be sent for culture and sensitivity when women report symptoms consistent with cystitis. symptomatic uti will be defined using strict culture-based definitions. we anticipate that the study will end within 6 weeks of starting cisc. data analysis: primary and secondary outcomes will be evaluated with student t test and fisher exact test. sample size: assuming a decrease in symptomatic utis attributable to nitrofurantoin prophylaxis from 33% to 10%, with 80% power, and a two-sided alpha of 0.05, and a 10% dropout rate, we should recruit a total of 108 patients.

Eligibility criteria:
inclusion criteria: * women who fail a post-operative voiding trial and are willing to learn clean intermittent self-catheterization (cisc) prior to discharge from the hospital exclusion criteria: * known drug allergy to nitrofurantoin * a history of renal insufficiency * renal transplant * renal nephropathy * a recent history of more than 3 urinary tract infections (utis) per year * known immunocompromised condition (organ transplant, chemotherapy for cancer or arthritis, autoimmune diseases (lupus etc)).

Keywords: urinary catheterization urinary tract infection urinary incontinence pelvic floor prolapse antibiotics
clinical evaluation of the 3 allergens: methyldibromoglutharonitrile, parthenolide and goldnatriumthiosulphate

Conditions: Allergic Contact Dermatitis

Summary: it is the purpose of this study to determine the concentration of 3 allergens (goldnatriumthiosulphate, methyldibromoglutharonitrile \[mdbgn\], parthenolide) for diagnosing allergic contact dermatitis.

the true test standard panel consists of two tape strips, panel 1 with 11 allergen patches and a negative control and panel 2, with 12 allergen patches. true test panel 1 and 2 contain 23 of the most frequent contact allergens.with these 23 allergens, it is possible to detect about 60-70% of contact allergic reactions. thus, there is a need for expanding the number of allergens included in true test in order to detect more contact allergic reactions. therefore goldnatriumthiosulphate, methyldibromoglutharonitrile and parthenolide are developed for inclusion in a third true test panel. this study is a dose-response study using 3 dilution series to detect the optimum concentration of the 3 allergens. a phase-iii study will be performed afterwards to establish the efficacy and safety of the three allergens.

Eligibility criteria:
inclusion criteria: * positive mdbgn patch test within the latest 5 years or positive parthenolide patch test within the latest 5 years or positive goldnatriumthiosulphate patch test within the latest 5 years. * age more or equal to 18 years. * signed informed consent. exclusion criteria: * topical treatment with corticosteroids or immunosuppressives during the latest 7 days on the test area or near the test area. * systemic treatment with corticosteroids or immunosuppressives during the latest 7 days. * treatment with uv-light during the latest 3 weeks. * widespread active dermatitis or dermatitis on test area. * breast-feeding, pregnancy or insufficient contraception. if any doubt a negative urine-pregnancy test should be demonstrated or the patch test should be postponed one period. * subjects not able to cooperate. * participation in other clinical studies during the study period and 3 weeks prior to study start.

Keywords: allergic contact dermatitis,patch testing, dilution series