Kornimate/medical-research-clean huggingface dataset:
effect of transcutaneous electrical acupoint stimulation on dyspareunia

Conditions: Dyspareunia (Female)

Summary: transcutaneous electrical acupoint stimulation (teas)was proven to stimulate the secretion of endogenous opioid peptides which are partial substitutes for the exogenous opioids stimulated by drugs in the central nervous system and can thus relieve pain. till now there is no previous study that investigates the effect of teas on dyspareunia. this study will determine the effect of transcutaneous acupoint stimulation on dyspareunia. patients will be divided randomly into two groups equal in number: the control group will receive only topical medication. the study group will receive acu-tens and topical medication.

patients will be divided randomly into two groups equal in number: control group (group a): it will include 19 women with dyspareunia. they will receive only topical medication (lidocaine ointment applied as required for symptoms and 30 minutes before sexual activity). study group (groupb): it will include 19 women with dyspareunia. they will receive acu-tens (30 minutes per session, once per week for 10 weeks), and topical medication (lidocaine ointment applied as required for symptoms and 30 minutes before sexual activity). all females will be given a full explanation of the study protocol and a consent form will be signed by each female before participating in the study

Eligibility criteria:
* inclusion criteria: * women complain of secondary dyspareunia, diagnosed and referred by the gynecologist. * multiparous women. * their ages will range from 25-35 years. * their body bmi will be less than 35 kg/m². * their pain level on the vas will be ≥ 4. * all the women were negative for vaginal infections caused by viruses, bacteria or fungi. * exclusion criteria: * pregnancy * malignancy. * the presence of an intrauterine device, vaginal infection, or skin/mucous lesions. * diabetes mellitus. * dermatological abnormalities on the skin at acupuncture point. * severe uncontrolled cardiac patients or implanted cardiac rhythm devices. * dyspareunia with endometriosis. * fearing from electricity.

Keywords: dyspareunia,
patophysiological, nodal-based approach for crohn's disease excision

Conditions: Crohn Disease; Crohn's Ileocolitis

Summary: single centre prospective pilot study on surgery for crohn's disease (cd). cd universally recurs after surgery and no technique so far has been proven to reduce recurrence. the investigators speculate that a different surgical technique, based on pathophysiology of the disease may prove successful in reducing rates of recurrence. consecutive cd patients with a surgical indication for ileocolic disease will receive an extended procedure including a lymphadenectomy (pathophysiologic excision for crohn's disease). primary outcome will be endoscopic recurrence rates at 6 and 12 months from surgery.


Eligibility criteria:
inclusion criteria: * all consecutive patients undergoing surgery for ileocaecal/ileocolic cd in the minimally invasive unit at policlinico tor vergata are eligible to be enrolled. * informed consent exclusion criteria: * crohn's disease with a different localisation * recurrent disease * extensive jejunitis * \<18 years of age * cancer as primary indication for surgery * followed by gastroenterologists outside our centre, due to loss of follow up * ileostomy. if a patient undergoes ileostomy fashioning he will be excluded from the study and this will be reported
cost-effectiveness of implant treatment for the edentulous mandible

Conditions: Edentulous Mouth

Summary: the aim of this study is to assess the cost-effectiveness of the mandibular overdenture retained by one and two implants and the mandibular fixed prosthesis retained by four implants, based on a randomized clinical trial.

this randomized clinical trial alongside a cost-effectiveness analysis will include 48 edentulous individuals who meet eligibility criteria. participants will receive conventional complete denture treatment and will be randomized into three groups: single-implant mandibular overdenture group, mandibular overdenture retained by two implants, and fixed mandibular prosthodontics retained by four implants. cbct and panoramic radiographs will be obtained to assess if bone sites in three-dimensional terms have a minimum volume for receiving implants of at least 3.75 x 9 mm. all patients will receive titamax it cortical implants (neodent, curitiba, brasil) and correspondent prosthodontic components - o'ring/ball abutments for overdentures. satisfaction with the dentures and oral health-related quality of life impacts will be considered the measures of effectiveness for the three interventions. cost assessment and cost-effectiveness analysis will be performed from the healthcare provider perspective. further analysis will be performed using the patient's perspective, in which the costs will be estimated according to the reference price of dental procedures and treatments of the brazilian dental association (hierarchical brazilian classification of dental procedures - cbhpo) and the gross costs will be obtained from a panel of experts. quantification and costing of the resources will be carried out in three steps: identification of the relevant costs to the assessment; measurement of the resources used; and valuation of the resources. the costs will be calculated in brazilian currency for each patient until one year after treatment. incremental cost-effectiveness ratios will be calculated to assess the incremental cost for each unit of effectiveness.

Eligibility criteria:
inclusion criteria: * no contraindications for implant surgery (mainly related to uncontrolled systemic diseases) * present enough bone volume in the mandible for implant placement without the need of bone augmentation procedures. * be able to understand and answer the questionnaires used in the study * agree to participate by providing a written informed consent. exclusion criteria: * noncompliant participants * individuals who do not agree to be randomly allocated to the treatment study group * presence of signs of untreated temporomandibular disorders, uncontrolled systemic or oral conditions that require additional treatments

Keywords: overdenture dental implant complete denture cost analysis
covid feel good-an easy self-help virtual reality protocol to overcome the psychological burden of coronavirus

Conditions: COVID-19 Pandemic Psychological Impact; Stress; Anxiety Disorders; Depression; Social Isolation

Summary: this pragmatic trial aims to evaluate whether a weekly self-help virtual reality protocol can help overcome the psychological burden of the covid-19 pandemic. the protocol is based on 'the secret garden' 360° vr video available online (www.covidfeelgood.com) which simulates a natural environment to promote relaxation and self-reflection. the vr experience is combined with daily cognitive and social exercises designed to facilitate critical examination of personal identity, relationships, and coping strategies. the study assesses whether this intervention can reduce anxiety, depression, perceived stress, and hopelessness while improving well-being and social connectedness during pandemic-related restrictions.


Eligibility criteria:
inclusion criteria: * adult participants (≥18 years) * native speakers of the country where they will be enrolled * have experienced at least two months of quarantine or isolation related to the coronavirus pandemic * provide full, written, informed consent * have the availability of a smartphone and a cardboard vr headset * availability and agreement of a partner for conducting the self-help component of the treatment exclusion criteria: * visual or hearing impairments that can limit the participation in the protocol * participants reporting vestibular and/or balance disorders

Keywords: virtual reality self-help mental health relaxation social connectedness pandemic coping nature simulation
isometric exercise and endogenous pain inhibition

Conditions: Fibromyalgia

Summary: the purpose of this study is to identify the acute effects of isometric exercise on the inhibition of pain in individuals with fibromyalgia.

fibromyalgia syndrome (fms) is a chronic pain condition that is characterized by widespread pain which affects 5-8% of the general population. past research has shown that people with fms demonstrate enhanced pain facilitation and reduced pain inhibition in the central nervous system. incorporating a biopsychosocial model of pain may help develop strategies to prevent the functional decline and alleviate the suffering that occurs in this population. exercise is a mainstay of pain rehabilitation with multiple health benefits, one of which is decreasing pain; a phenomenon known as exercise induced hypoalgesia (eih). emerging evidence has shown that exercise decreases pain facilitation in healthy adults and in some individuals with fms. however, it's unclear whether exercise improves pain inhibition in individuals with fms. the purpose of this study is to investigate endogenous pain inhibition, measured by conditioned pain modulation (cpm), following isometric exercise of the quadriceps muscle in individuals with fms. in addition, factors that might affect this response such as physical activity, body composition, and psychosocial issues will be examined. understanding how exercise impacts pain and the contributing factors will help guide the prescription of exercise to optimize pain rehabilitation.

Eligibility criteria:
inclusion criteria: * men and women aged 18-75 diagnosed with fibromyalgia or healthy controls will be included in the study. exclusion criteria: * cardiovascular disease, cancer, pregnancy, arthritis, diabetes, claustrophobia, reynaud's disease, osteoporosis, neuropathy.

Keywords: exercise pain sensitivity fibromyalgia
ostomy in continuity or conventional ileostomy: a retrospective multicentric analysis

Conditions: Intestinal Obstruction; Gastroschisis; Enterocolitis, Necrotizing; Hirschsprung Disease

Summary: surgical procedures for complex intestinal neonatal and paediatric diseases may require the use of an ostomy, in order to discharge the upper intestine. the traditional loop ileostomy has recently be challenged by ileostomies in continuity, either the santulli or the bishop-koop one, that both decompresses the proximal dilated bowel and allow intestine fluid to pass through the underlying ileal anastomosis. nevertheless, to date, no evaluation of their indications, complications and potential benefits has been made. the aim of this study is to retrospectively compare the outcomes of loop ileostomies and ileostomies in continuity in a paediatric population. it is thus expected to better define the specific indications for these different types of ileostomies in the paediatric and neonatal population.

the methodology used will be a retrospective non interventional study of the cohorts of paediatric patients having had one or more ileostomies performed in one of the surgical centers participating in this study, between 2007, january the 1st and 2019, august the 31th. the main outcome will be the duration (days) between full refunctionalization of the bowel in the groups of conventional ileostomy or ostomy in continuity, as assessed by the end of parenteral nutrition or the closure of the stoma. secondary outcomes will include (1) the number and type of complications directly related to the stoma and/or to intestinal complications; (2) the comparison of the results obtained by santulli and bishop-koop ileostomies; (3) a sub-group analysis of the outcomes in the different underlying pathologies.

Eligibility criteria:
inclusion criteria: * all patient aged 16 or less having had one or more ileostomy created as part of its care for an intestinal obstruction, between 2007/01/01 and 2019/08/31. if a patient requires more than one ileostomy, each new stoma will be analysed as a new entry in the study. * patients having been operated in one of the paediatric surgical department participating in this study. exclusion criteria: * refusal or absence on consent of the patient and/or their legal representative to participate to the study. * patient who had an ileostomy created in another center than the ones participating in the present study.

Keywords: ileostomy enteral nutrition complications of stoma
antithrombotic activities of sotagliflozin vs. empagliflozin

Conditions: Thrombosis

Summary: the availability of sodium-glucose cotransporter-2 inhibitors (sglt2-i) has dramatically altered the management of heart failure (hf) patients, independently of their ejection fraction and glycemic status. a meta-analysis of 57 studies comparing sglt2-i monotherapy vs. placebo or active comparator showed reductions in major cardiovascular events, but no impact on atherothrombotic events. in fact, a non-significant increase in the risk for non-fatal stroke was observed. similar trend observed in multiple trials indicate a sglt2-i class effect. sotagliflozin is the first dual sglt1/2 receptor inhibitor, that was shown to significantly reduce atherothrombotic events compared with placebo in diabetic hf patients, suggesting that dual sglt1/2 inhibitor may have additional properties vs. sglt2-i. the hypothesis of this study is that dual sglt1/2 inhibition by sotagliflozin improves thrombogenic profile (i.e. reduces thrombus formation), which could make it a safer and more effective treatment option for cardiovascular (cv) patients than sglt2-i. to test the hypothesis, the researchers will compare the antithrombotic activity of sotagliflozin vs. empagliflozin in healthy volunteers using a randomized, cross-over study design, where each participant will receive both study treatments (sotagliflozin and empagliflozin) separated by a washout period. treatment effects will be assessed by measuring ex vivo thrombus formation using the badimon perfusion chamber, platelet aggregation using multiplate analyzer, and thromboelastometry using rotem gamma. study assessments will be performed before initiating (baseline/pre-treatment) and after completion of each treatment.


Eligibility criteria:
inclusion criteria: subjects are eligible if they meet all of the following criteria: * male or female volunteers older than 18 years old. * disease-free as assessed by medical history and physical examination. * ability to provide signed informed consent. exclusion criteria: subjects will be excluded if they meet any of the following criteria: * pregnant or lactating women * history of clinically relevant cardiovascular, pulmonary, hepatic, gastrointestinal, renal, metabolic, hematologic, neurologic, respiratory or psychiatric disease, bleeding, acute infectious disease or signs of acute illness. * use of medication within one month prior to study drug administration or within six times the elimination half-life (whichever is longer), except for oral contraceptives or occasional use of acetaminophen or an antihistamine. * history of drug abuse or alcohol consumption \>20 g/day \[125 ml (30ml=1oz) glass of 10% wine = 12.5 g, 40 ml aperitif of 40% = 17 g, 250 ml glass of 6% beer = 15g\] * loss of \>400 ml blood or blood donation within 3 months. * conditions associated with hemorrhagic risk, e.g., frequent epistaxis, gastrointestinal ulcer, hemorrhagic vascular lesions, recent surgery.

Keywords: thrombosis platelets heart failure sglt2 sglt1/2
nutritional state and intake nutrients assessment in ulcerative colitis

Conditions: Ulcerative Colitis in Remission

Summary: the purpose of this study is to determine the reason patients are deficient in nutrients intake such as antioxidants vitamins.


Eligibility criteria:
inclusion criteria: * patients with ulcerative colitis in remission * age \> 18 yo exclusion criteria: * patients with ulcerative colitis in activity * those patients with food intake trouble * those patients with bowel resected

Keywords: nutritional state nutrients intake ulcerative colitis
progesterone and atomoxetine for cocaine cessation

Conditions: Cocaine Dependence; Nicotine Dependence

Summary: the purpose of this study is to examine the role of progesterone (a hormone found in both men and women) on stopping cocaine use. the study will examine whether the medication, in combination with behavior therapy will decrease cocaine use, cigarette smoking, withdrawal symptoms, impulsivity and stress.


Eligibility criteria:
inclusion criteria: * females between 18 and 45 and males between 18 and 60 years-of-age; * understand the study procedures and provide written informed consent; * meet dsm-iv criteria for cocaine or methamphetamine and nicotine dependence; * minimum of cocaine use 4 days/months over last 3 months; * minimum of 5 cigarettes/day for last twelve months; * stable psychiatric status; * stable medical status; willing to use double-barrier contraception method if sexually active and not surgically sterilized; * regular menstrual cycles (for females); * no contraindications to progesterone treatment; * ability to participate fully in research elements for the duration of the trial. exclusion criteria: * dsm-iv diagnoses for current or lifetime psychotic disorders (unless substance induced), bipolar disorder, current adhd and other current substance dependence (except nicotine dependence, or alcohol or cannabis dependence not exhibiting withdrawal or other features requiring medical attention); * currently using nicotine pharmacotherapy preparations; * history of thromboembolic events, diabetes, stroke, heart disease; * psychotropic medications other than stable doses of anti-depressants; * currently pregnant or nursing; * liver enzyme levels three times normal limits; * previous treatment with or adverse response to progesterone. * serious suicide attempt within preceding 2 years; * current use of exogenous hormones. * conditions contraindicated to progesterone treatment (including, but not limited to, thrombophlebitis, deep vein thrombosis, pulmonary embolus, clotting or bleeding disorders, heart disease, diabetes, history of stroke, allergy to peanuts, hypersensitive to progesterone and liver dysfunction). * history of pheochromotytoma or narrow angle glaucoma, * current hypertension, tachycardia or clinically relevant ecg abnormalites; * allergy to peanuts, * current suicidality or need for emergency psychiatric treatment.
the effects of quetiapine (seroquel xr) on sleep during alcohol abstinence

Conditions: Alcoholism; Sleep Initiation and Maintenance Disorders

Summary: the primary purpose of this study is to determine how efficacy of quetiapine (seroquel xr) in improving the sleep in recovering alcohol dependent subjects.

sober alcohol dependent subjects frequently complain of difficulty falling asleep as well as staying asleep which may eventually lead to relapse. novel antipsychotic medications such as quetiapine have shown some efficacy in treating alcoholism and have also shown some benefit in improving insomnia. the primary aim of this study is to determine the degree to which quetiapine improves sleep in veterans during the early phase of recovery from alcohol dependence. the sleep efficiency from an in-lab polysomnogram will be the primary outcome measure. secondary measures of sleep will include the pittsburgh sleep quality index, insomnia severity index, and actigraphy. other additional aims will explore for alcohol use and cravings, change in psychiatric symptoms using the the time line follow back measure, penn alcohol craving scale (pacs), the patient health questionnaire-9 item scale (phq-9), and the beck's anxiety inventory (bai) respectively. twenty four subjects within the first year of sobriety will be enrolled. participants will be undergo an extensive baseline screening procedure. after 2 consecutive in-laboratory polysomnograms they will be treated with either quetiapine xr or matching placebo pills targetting a dose of 400 mg a night. the treatment duration will be 8 weeks and during the eight week of treatment they will undergo 2 more nights of in-laboratory polysomnogram. all subjects will also receive medical management therapy, a standardized psychosocial intervention which is medically-based and focusses on alcohol abstinence and medication compliance.

Eligibility criteria:
inclusion criteria: subjects between the ages of 18-65 years, with a dsm-iv diagnosis of current alcohol dependence (past year), can speak, understand, and print in english, and is capable of giving written informed consent exclusion criteria: positive urine drug screen for opioids, cocaine, or amphetamine (excluding thc), dependence on other drugs excluding alcohol/nicotine/cannabis over the past year, unstable psychiatric, medical disorders, cataracts \[posterior capsular/ nuclear (grade ns3 or more), currently on any maintenance psychotropic medications affecting sleep, currently pregnant, nursing, or not using a reliable method of contraception; history of hypersensitivity to antipsychotic drugs, including quetiapine, severe cognitive impairment, severe untreated obstructive sleep apnea, and inadequately controlled diabetes mellitus.

Keywords: alcoholism insomnia quetiapine seroquel
a study of simbrinza™ therapy in patients with open-angle glaucoma or ocular hypertension

Conditions: Open-Angle Glaucoma; Ocular Hypertension

Summary: this study is a retrospective chart review to assess the tolerability and efficacy of treatment with simbrinza™ used for patients with open-angle glaucoma or ocular hypertension.


Eligibility criteria:
inclusion criteria: * participants treated with simbrinza™ for intra-ocular pressure (iop) lowering in at least one eye * participants who had at least one-follow-up visit with tolerablity and efficacy data after simbrinza™ treatment initiation. exclusion criteria: * active ocular disease other than glaucoma or ocular hypertension * history of any intraocular surgery or glaucoma laser surgery within 3 months.
the evaluation of the efficacy and safety of donepezil hydrochloride in subjects with mild cognitive impairment (mci)

Conditions: Memory Loss

Summary: to investigate the efficacy and safety of donepezil in individuals with mild cognitive impairment on measures of cognition, global function and behavior.


Eligibility criteria:
inclusion criteria: * memory complaint * mini mental status exam (mmse) score 24-28 inclusive * general cognition and function performance sufficiently preserved such that a diagnosis of alzheimer's disease (ad) cannot be made * generally healthy and ambulatory * sufficiently fluent in english exclusion criteria: * diagnosis of probable or possible ad * neurological disorders * history of malignant cancers * previously have taken donepezil or other acetylcholinesterase (che) inhibitors for more than 1 month or in the past 3 months prior to study entry

Keywords: cognitive impairment memory loss
a study to evaluate the safe and effective use of the prefilled safety syringe or the auto-injector for the subcutaneous self-injection of bimekizumab solution by subjects with active psoriatic arthritis

Conditions: Psoriatic Arthritis

Summary: the purpose of the study is to evaluate for each self-injecting device presentation the ability of subjects with psoriatic arthritis (psa) to safely and effectively self-inject bimekizumab at study start and 4 weeks after training in self-injection technique using the bimekizumab safety syringe (ss) or the bimekizumab auto-injector (ai).


Eligibility criteria:
inclusion criteria: * subject fulfills all inclusion criteria for the pa0012 \[nct04009499\] study * subject is considered reliable and capable of adhering to the dv0004 protocol (eg, able to understand and complete questionnaires, able to use investigational self-injecting device presentations according to the instructions for use (ifu), and able to adhere to the visit schedule) according to the judgment of the investigator * subject is willing to self-inject exclusion criteria: -subjects are not permitted to enroll in dv0004 if any of the pa0012 \[nct04009499\] study exclusion criteria are met

Keywords: psoriatic arthritis psa auto-injector bimekizumab