Kornimate/medical-research-clean huggingface dataset:
ambispective cohort study to evaluate the efficacy, safety, and tolerance of an antiretroviral regimen with doravirine

Conditions: Hiv

Summary: observational, ambispective single-center cohort study, including 150 patients who received or are receiving a doravirine-based regimen plus two nrti or a dual therapy of doravirine plus dolutegravir (dtg) or bdrv in routinely clinical practice.

observational, ambispective single-center cohort study, including 150 patients who received or are receiving a doravirine-based regimen plus two nrti or a dual therapy of doravirine plus dolutegravir (dtg) or bdrv in routinely clinical practice. all patients who were switched to a doravirine-based regimen from date of its availability in the center (september 2020) due to clinical considerations and have available records will be retrospectively included until date of study approval (expected on july 2021). minor resistances in a basal genotype to nnrti or previous failure to nnrti as nevirapine or efavirenz will be accepted if doravirine it is combined with a high genetic barrier drug with complete activity.

Eligibility criteria:
inclusion criteria: * older than 18 years hiv-1 infected subjects. * switched to a doravirine-based art regimen under clinician criteria. exclusion criteria: * doravirine major resistance mutations (accessory mutations are allowed). * major mutations to any of the other drugs combined with doravirine. * pregnancy, active tuberculosis or any condition that contraindicate the use of doravirine.
aki prevention and early intervention in vad patients admitted for acute medical events.

Conditions: Acute Kidney Injury

Summary: the investigators are doing this research to investigate whether multifaceted preventive measures for newly hospitalized ventricular assist device (vad) patients will reduce the acute kidney injury (aki) occurrence rate, progression and associated complications

the purpose of the study is to investigate whether preventive measures for newly hospitalized ventricular assist device (vad) patients will reduce the acute kidney injury (aki) occurrence rate, progression and associated complications participants will be in the study for the first 7 days of hospitalization. the study investigators will access the electronic medical record daily from admission day 1 through admission day 7 in order to provide clinical recommendations in an effort to minimize aki risk as per routine practice. if the patient is discharged prior to day 7 the study, intervention will be terminated on day of discharge. the investigators will review the participant's medical record up to one year after surgery. this study will not include any experimental laboratory tests or experimental medication. the clinical recommendations will regard the following: 1. avoidance of potentially nephrotoxic medications (e.g. nsaids, intravascular contrast, nephrotoxic antimicrobials) 2. optimizing volume status (avoidance of volume overload or depletion) 3. optimizing electrolytes and acid-base status 4. optimizing hemodynamics (mean arterial bp\>65mmhg) 5. assessment of kidney function with serum creatinine and/or cystatin c none of the suggestions will be experimental. all suggestions will be based on standard nephrology practice. the investigators plan to compare the results of the current study with those in in the years of 2012-2017 (1/7/2012- 1/7/2017) via retrospective chart review

Eligibility criteria:
inclusion criteria: adult patients with vad in place who are admitted to the hospital for acute medical illness during the study period. for those with multiple admissions during the study period only the first admission will be studied. patients who are able to give consent. in case of patients that are mentally impaired we will obtain consent from power of attorney and when patients regain intact mental capacity we will reobtain consent from the patient. exclusion criteria: patients on dialysis (hemodialysis or peritoneal dialysis).

Keywords: ventricular assist device
response inhibition in tourette syndrome

Conditions: Tourette Syndrome

Summary: tics are the hallmark symptoms in tourette syndrome. patients with tourette syndrome have difficulties controlling unwanted movements. the ability to control the motor system involves the pre-supplementary motor area (pre-sma) in the brain. in this study, we will use transcranial magnetic stimulation to modulate the pre-sma and determine effect on the ability to stop an unwanted action in a behavior task (stop signal task).


Eligibility criteria:
inclusion criteria: * tourette syndrome exclusion criteria: * autism spectrum disorder * mood disorder * epilepsy * implanted medical device (e.g. pacemaker, shunt, pumps)
heart disease and the black health disadvantage

Conditions: Cardiovascular Diseases; Heart Diseases; Coronary Disease

Summary: to utilize national population data sets prepared by the national center for health statistics, to (1) examine the current black disadvantage in cardiovascular (cv) health, (2) explore potential clinical and epidemiologic causes, (3) incorporate emerging knowledge of new risk factors and (4) compare trends in medical treatment and risk factors for the four sex-race groups.

background: the black health disadvantage remains a pressing public health issue in the united states. according to the department of health and human services 'black and minority health report', 65,000 excess deaths occur each year among blacks when compared to the mortality experience of whites. cardiovascular diseases make by far the largest contribution to this loss of life, accounting for over 30 percent of the excess. despite improvements in cv mortality for all four major sex-race groups during the 1970's, the trends in heart disease in the united states began to diverge. a 50 percent slowing of the decline in coronary mortality occurred among blacks from 1978-1986, compared to whites, and the gap in life expectancy between the races has widened. as noted in the 'report', despite the widespread recognition of the importance of the problem, our knowledge regarding the causes of these differentials in cv disease was inadequate. to address this problem, the report recommended support for 'innovative uses of current data' and 'cross-comparisons from different data sets', emphasizing the unique contribution population-based studies can make to 'understanding the health status and needs of minority populations'. given the deterioration of the black health status relative to the majority population, these recommendations took on new urgency. design narrative: several separate analyses were conducted of prevalence surveys, epidemiologic followup studies, hospitalization surveys and vital statistics. these separate analyses were subsequently combined into a comprehensive description of the clinical and epidemiologic determinants of the black cv disadvantage, and its future trends. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
a trial to assess the efficacy and safety of 400mg/day lacosamide in subjects with painful diabetic neuropathy

Conditions: Painful Diabetic Neuropathy

Summary: the purpose of this trial is to assess whether 400mg/day of lacosamide is effective in reducing pain caused by distal diabetic neuropathy. two dose-escalation schemes for lacosamide will be used to further determine the efficacy of the "standard" scheme and to evaluate the efficacy and safety of a more rapid titration scheme. subjects will be randomly assigned to one of three treatment groups. subjects in two of the groups will receive lacosamide at a dose of 400mg/day, but different dose-escalation schemes will be used to reach this final dose. the third group of subjects will receive a placebo. subjects will have a 2 in 3 (66 %) chance of getting lacosamide. the maximum lacosamide dose in this trial will be 400mg/day. the maximum treatment duration will be 18 weeks, including a two-week pre-treatment phase and a 12 weeks period on a stable dose of lacosamide or placebo.


Eligibility criteria:
inclusion criteria: * subject has had symptoms of painful diabetic neuropathy for at least 6 months and has a diagnosis of diabetes mellitus (type i or type ii). exclusion criteria: * subject has previously participated in this trial or subject has previously been assigned to treatment in a trial of the drug under investigation in this trial

Keywords: painful diabetic neuropathy lacosamide
frequency of sexual intercourse,women with fibromyalgia

Conditions: Fibromyalgia; Pain; Depression

Summary: does frequency of sexual intercourse affect symptom severity in female patients with fibromyalgia?


Eligibility criteria:
inclusion criteria: \* female patient with fibromyalgia exclusion criteria: * uncontrollable systemic disease (cardiovascular, pulmonary, hepatic, renal, hematological), * major psychiatric disease, * endocrine disease, * pregnancy * menopausal status, * antihypertensive, antidepressant, anxiolytic, antiepileptic drugs use
the bread study - bio-availability of d2 vitamin present in bread

Conditions: Serum 25-hydroxyvitamin D Concentrations (25OHD)

Summary: vitamin d3 is synthesized in skin exposed to ultraviolet-b-irradiation of sunlight. however, in northern europe, including finland, exposure to sunlight is limited or non-existent in winter. between november and march, dietary or supplementary vitamin d intake is essential to maintain adequate serum 25-hydroxyvitamin d (s-25(oh)d) concentrations. there are only a few natural dietary sources of vitamin d. fish and egg yolks contain significant amounts of vitamin d3 (cholecalciferol), and some wild mushrooms are a source of vitamin d2 (ergocalciferol). thus, vitamin d fortification of certain foods has been accepted as one strategy to improve vitamin d status of these populations. vitamin d3 is currently mostly used in fortified products in europe, although the production of plant-derived vitamin d2 would be more cost-effective. data on the impact of food-derived vitamin d2 on s-25(oh)d3 are limited. an important consideration is whether food-based sources of vitamin d2 are effective in raising s-25(oh)d or whether they have a negative impact on s-25(oh)d3. the investigators investigated the bioavailability of vitamin d2 from uvb-radiated baking yeast in bread in terms of efficacy of raising total s-25(oh)d) as well its possible effects on s-25(oh)d2, s-25(oh)d3, serum parathyroid hormone (s-pth) and serum calcium concentrations compared with d2 and d3 supplementation in a randomized placebo-controlled trial in young healthy females during winter in finland.


Eligibility criteria:
inclusion criteria: * good general health (no continuous medication), * caucasian origin, * body mass index (bmi) \<30 kg/m2 * age 20-40 years exclusion criteria: * diagnosed celiac disease or cereal allergy * a vacation in a sunny place during the study or within the preceding 2 months * regular use of vitamin d supplements \>15 µg/d * pregnancy or breastfeeding during the study

Keywords: vitamin d serum 25-hydroxyvitamin d vitamin d2 uv-irradiated yeast serum 25-hydroxyvitamin d3 serum 25-hydroxyvitamin d2 randomized controlled trial vitamin d3 bioavailability
assessment of pruritus improvement with pimecrolimus treatment on the areas affected by mild-to-moderate ad, in patients 2- to 11- year-old

Conditions: Atopic Dermatitis

Summary: the purpose of this study is to assess the efficacy and safety of pimecrolimus cream 1% in relation to the improvement of pruritus in pediatric patients (2- to 11- year-old) with mild to moderate atopic dermatitis.


Eligibility criteria:
inclusion criteria: * male or female. * age: between 2 - 12 years. * outpatients with diagnosis of atopic dermatitis * atopic dermatitis affecting ≥ 5% of total body surface area at baseline investigator's global assessment score of 2 (mild) or 3 (moderate). * baseline visit pruritus (itching) severity assessment score of 2 (moderate) or 3 (severe). * patients or patient's legal guardian who has been informed of the study procedures and has signed the informed consent form approved for the study prior to starting any study related procedures, including washout (in case that it would be necessary). exclusion criteria: * patients being breast-fed by women receiving systemic or prohibited medication. * children with known hypersensitivity to study medication. * children who received phototherapy or systemic therapy (immunosuppressants, cytostatics) known to affect atopic dermatitis within the previous month or topical therapy (tar, topical corticosteroids), systemic corticosteroids, systemic antibiotics or leukotriene antagonists within the previous week. * children who received investigational drugs within 8 weeks prior to first application of study medication. * children who had concurrent skin disease or active bacterial, viral or fungal infection. * immunocompromised children (e.g., lymphoma, aids, wiskott-aldrich syndrome) or children with a history of malignant disease. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: atopic dermatitis, children, pimecrolimus, eczema
ultrasound-guided transversus abdominis plane block after hysterectomy

Conditions: Post Operative Pain

Summary: in this randomized, controlled, observer-blinded study we plan to evaluate ultrasound-guided transversus abdominis plane (tap) block for postoperative pain management in patients undergoing abdominal hysterectomy.

patients undergoing abdominal hysterectomy (n=75) at parkland hospital will be randomized into one of three groups to receive either ultrasound-guided bilateral tap block with or without nsaids and acetaminophen (groups 1 and 2) or the conventional analgesic regimen (group 3) for postoperative pain management. the remaining aspect of perioperative care, including the general anesthetic technique, will be standardized and similar for all patients. the duration of the involvement in the study will be until 48 hours postoperatively. the pre-anesthesia care unit personnel will identify patients during their preoperative clinic visit. there will be no incentive or payment to the patients. patients in group 1 and 2 will receive ultrasound-guided bilateral tap block after surgery. in the first 24-h postoperative period, patients in groups 1 and 3 will receive acetaminophen 650 mg every 6 h orally, ketorolac 30 mg every 6 h, and morphine via an intravenous patient controlled analgesia (iv-pca) system to maintain adequate pain control. patients in group 2 will receive iv-pca morphine for the first 24 hours in addition to the ultrasound-guided bilateral block. in the 24-48 h study period, all patients will receive oral ibuprofen 800 mg three times a day and a combination of hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets every 6h, prn. the postoperative analgesia will be documented using the visual analog score (0=no pain,10=worst pain). in addition, total opioid dose over the 48-h study period will be documented. postoperative nausea will be measured using a categorical scoring system (none=0, mild=1, moderate=2, severe=3) and episodes of vomiting will be documented. rescue antiemetics will be given to any patient who complains of nausea or vomiting. all variables will be assessed at 2, 6, 12, 24, and 48 hours, postoperatively by an investigator blinded to group allocation. primary endpoint will be in about 24 hours after surgery morphine consumption. the secondary endpoints will include the vas pain score at 6, 12, 24 and 48 hours after surgery and side effects associated with morphine use.

Eligibility criteria:
inclusion criteria: * 18-80 years old * female asa physical status 1-3 scheduled for abdominal hysterectomy * able to participate personally or by legal representative in informed consent in english or spanish exclusion criteria: * history of relevant drug allergy * age less than 18 or greater than 80 * chronic opioid users who may have a tolerance to opioids * psychiatric disturbance * inability to understand the study protocol procedures * patient refusal

Keywords: postoperative pain, tap block, hysterectomy
giotrif in first line therapy of advanced nsclc with egfr-mutations

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: this observational study will investigate the efficacy, safety, tolerability and symptom control of giotrif (afatinib) in daily routine first-line therapy in patients with locally advanced or metastatic nsclc harboring egfr-mutations. eligible nsclc patients, for whom the treating physician has decided to initiate treatment with giotrif in first line according to the local label, will be followed up for approximately 24 months.

study design:

Eligibility criteria:
inclusion criteria: * egfr- tyrosine kinase inhibitor (tki) naive patients with histologically confirmed locally advanced or metastatic nsclc with activating egfr-mutations * age \>= 18 years * no diagnostic or therapeutic measures beyond routine clinical practice are required * patients for whom the treating physician has decided to initiate treatment with giotrif * written informed consent prior inclusion exclusion criteria: * contraindication for afatinib according to the summary of product characteristics * participation in another clinical study until 30 days after end of treatment * prior systemic chemotherapy (neo-/adjuvant therapy is permitted) * previous treatment with an egfr-tyrosine kinase inhibitor * patients not willing or not able to fill in quality of life questionnaires * patients with missing or impaired legal capacity * pregnancy
decision support following genetic testing for breast-ovarian cancer susceptibility

Conditions: Breast Cancer; Ovarian Cancer

Summary: this non-therapeutic trial is for women who have received results of genetic testing for brca1/2 mutations. the trial compares decision support tools designed to facilitate informed decision making regarding risk management following testing to usual care. the researchers will test separate decision support tools for women who receive positive test results and women who receive negative/inconclusive test results. among women who receive a positive test result, an interactive decision support intervention will be compared to a print intervention. among women who receive an inconclusive result, an interactive intervention will be compared to usual care.


Eligibility criteria:
inclusion criteria: * undergo brca1/2 genetic counseling and testing at one of four study sites * receive positive or uninformative test results * english speaking exclusion criteria: * newly diagnosed breast cancer patients who have not yet initiated definitive breast cancer treatment * previous bilateral mastectomy

Keywords: genetic counseling genetic testing brca1 brca2 hereditary breast cancer hereditary ovarian cancer
tissue repair gel in venous leg ulcers in au/us

Conditions: Venous Leg Ulcer; Venous Ulcer; Venous Stasis Ulcer; Venous Stasis; Wound Heal; Wound; Venous Insufficiency of Leg; Non-healing Wound

Summary: the goal of this clinical trial is to learn if tr987 0.1% gel + standard of care works better than standard of care alone to treat venous leg ulcers (vlus). it will also provide additional information about the safety of drug tr987 0.1% gel.

this is an outpatient, randomized, parallel- group, double-blind, multicenter, 16-week study with 2 treatment arms: tr987 0.1% gel + standard of care and standard of care alone in participants who have a non-healing venous leg ulcer (vlu). the primary objective is to assess the proportion of participants with complete closure of the target ulcer at or before the week-16 end of treatment (eot) visit. secondary endpoints include: * proportion of participants with complete closure of the target ulcer at or before the week 16 visit and for whom the ulcer remains closed at the 3-month follow-up visit after such closure (a composite endpoint). * change from baseline in participant's perception of pain level at 12 weeks. * percent change from baseline in the target ulcer area at 12 and 16 weeks. in the event of complete closure before these time points, the target ulcer area will be deemed to be zero at those time points for purposes of calculation of this endpoint. * proportion of participants with complete closure of the target ulcer at or before the week 12 treatment visit. * proportion of participants with any significant reduction in pain at or before 12 weeks. there are also some supplementary and safety endpoints.

Eligibility criteria:
inclusion criteria: * adults 18 years and older * venous insufficiency has been clinically diagnosed clinically and medically confirmed. * females who are neither pregnant nor breastfeeding and if of child-bearing potential are on an acceptable method of birth control. * the venous ulcer should be between 2 cm2 and 12 cm2 at randomization. * target ulcer age must be ≥ 4 weeks at screening. * participants must have adequate arterial flow as confirmed by abi/tbi, tb, spp, tcpo2, or duplex doppler. * body mass index (bmi) ≤ 50 kg/m2. * hba1c ≤12%. exclusion criteria: * target ulcer has been treated with prohibited medications or therapies. * history of radiation at the target ulcer site. * target ulcer decreases in area by 30% or more during screening period. * history of osteomyelitis at the target ulcer within 6 months of screening. * history of cancer in the preceding 5 years (except as noted in the protocol). * participants considered nutritionally deficient.

Keywords: tissue repair glucoprime tr therapeutics debridement vlu
simplified versus conventional technique for complete denture fabrication.

Conditions: Edentulous

Summary: the purpose of this study is to evaluate the effectiveness of a simplified technique of conventional dentures fabrication, comparing it to a traditional technique, by evaluating the impact of oral health on quality of life, satisfaction of individuals and chewing efficiency as well assessing the quality of prosthetics and tmd. furthermore, the cost involved in the manufacture of dentures through technique simplified will be compared to the cost involved in the traditional technique.

the traditional technique will be conducted through a protocol used by most dental schools in brazil and described in some clinical trials as a conventional technique for dentures fabrication. on simplified technical functional molding step is deleted, and thus the orientation planes are made directly on the resulting models of the initial molding alginate, and the mounting of the models is performed in semiadjustable articulators random with the aid of an auxiliary table 15 degrees with semiadjustable articulators fixed to the slope. to evaluate the impact on oral health quality of life of individuals will be used the brazilian version of oral health impact profile for edentulous patients (ohip-edent) for evaluation of patient satisfaction will use a specific questionnaire assessing the quality of the prostheses will be carried out through a specific exam, to assess the presence of tmd, all subjects will be evaluated through the rdc / tmd, for assessing the efficiency masticatory chewing capsules are used, the costs involved in the manufacture of prostheses will be calculated according to the material consumption used during the making of the prosthesis. all subjects will be assessed before making the prostheses and 90 days after installation of new dentures during this period will be held regular control visits. the data will be evaluated in order descriptive by numbers and proportions, moreover, it will be statistically evaluated by means of suitable tests.

Eligibility criteria:
inclusion criteria: edentulous individuals for more than one year and total bimaxillary prosthesis users that need a couple of new prostheses. exclusion criteria: pathological changes of alveolar ridges, motor problems and systemic diseases that may influence on the individual's adaptation to the prosthesis.

Keywords: denture, complete mouth, edentulous