Kornimate/medical-research-clean huggingface dataset:
histomorphometric and tomographic assessment on the influence of the placement of a collagen membrane subjacent the sinus mucosa after maxillary sinus floor augmentation

Conditions: Alveolar Bone Loss

Summary: the purpose of the study is to look for differences in dimensional variations of augmented maxillary sinuses with or without the placement of a collagen membrane subjacent the sinus mucosa.

material and methods: after the elevation of the maxillary sinus mucosa, a collagen membrane with standard dimensions will be placed at the test sites subjacent the sinus mucosa and the elevated space will be filled with a xenograft, both test and control groups. a collagen membrane will be placed to cover the antrostomy at both groups and sutures will be provided to close the wound. after six months of healing, mini-implants will be installed. after 9 months, biopsies containing the mini-implants will be harvested for histomorphometric analyses. cbcts will be taken for all patients before surgery (t0), after 1 week from sinus floor augmentation (t1) and after 9 months of healing (t2). osseointegration of the mini-implants and dimensional changes over time of soft and hard tissues will be evaluated on the cbcts.

Eligibility criteria:
inclusion criteria: * presence of an edentulous atrophic zone in the posterior segment of the maxilla * height of the sinus floor ≤4 mm * desiring a prosthetic restoration of the zone using a fix prosthesis supported by implants; * ≥ 21 years of age * good general health * no contraindication for oral surgical procedures * not being pregnant exclusion criteria: * present a systemic disordered * had a chemotherapic or radiotherapeutic treatment * are smokers \>10 cigarettes per day * have an acute or a chronic sinusitis * had a previous bone augmentation procedures in the zone of interest.

Keywords: maxillary sinus collagen membrane cbct histology
buccal estrogen in toothpaste study: systemic absorption of estradiol when administered mixed with toothpaste in postmenopausal or surgically menopausal women

Conditions: Menopause; Postmenopause

Summary: background: the use of estrogen in postmenopausal (or surgically menopausal) women is a common practice. compliance is problematic in that estimates show only 1/3 of women use hormone replacement therapy (hrt) and only 30% are compliant. estrogen has many documented benefits including symptomatic relief of hot flashes, improvement of the dry vagina and dyspareunia. estrogen has been found to improve bone mineral density and increase the high- density lipoprotein portion of a cholesterol panel. to improve compliance and to provide an alternate method of delivery, we propose the use of estrogen which is admixed in toothpaste and propose to study the absorption, rate of build-up and rate of decline. hypothesis: estrogen can potentially be absorbed systemically when toothpaste is admixed with estradiol and is applied in a timed, consistent fashion to postmenopausal or surgically postmenopausal women, not on hrt. absorption takes place across the buccal mucosa. specific aims:1) to estimate the systemic absorption of estrogen from daily use of estrogen containing toothpaste. 2) to estimate the rate of build-up of serum estrogen levels based upon daily use of toothpaste containing estrogen for eight days. 3) to estimate the rate of decline in serum estrogen levels when the use of estrogen containing toothpaste is discontinued for a week.

methods: fifteen women ages 35-75 who are menopausal or surgically menopausal will be identified, with exclusion based on estrogen contraindications. subjects will have blood samples taken before, during and after an eight-day course of once-daily toothpaste that is admixed with 0.5 mg estradiol. toothpaste shall meet strict quality control standards and instructions for uniform tooth brushing shall be provided. serum estradiol will be determined from the samples obtained. statistical analysis shall address absorption by comparing baseline estradiol measurements with those a few hours after use. the rate of build-up will be assessed by comparing the post-use levels of estradiol at the start of a week and at the end of the week. after a week off the estrogen, the rate of decline in serum estradiol will be calculated.

Eligibility criteria:
postmenopausal women or surgically menopausal women, not on hormone replacement therapy for at least 3 weeks

Keywords: surgical menopause
acute effect of forearm neuromuscular taping on pain, biological and functional variables post-exercise.

Conditions: KINESIOTAPING; NEUROMUSCULAR TAPING

Summary: this study aims to evaluate the acute effect of neuromuscular taping applied to the forearm on maximal grip strength, pressure pain threshold, and muscle oxygenation in healthy university athletes after exercise. using a randomized controlled trial design, the study aims to provide rigorous evidence that will help clarify the potential benefits of neuromuscular taping (nmt) in a sports context. the relevance of this research lies in providing useful information for health and sports professionals, facilitating informed decision-making regarding the use of this technique in daily practice. a randomized controlled trial will be conducted, with participants divided into four groups: two experimental groups, one placebo group, and one control group. one experimental group will receive nmt with proximal-to-distal tension, while the other will receive distal-to-proximal tension. the placebo group will receive nmt without tension, and the control group no nmt application.


Eligibility criteria:
inclusion criteria: * age between 18 and 30 years. * both genders. * body mass index between 18.50 and 23.99 kg/m². * no musculoskeletal disorders in the last 3 months and intact skin on the forearm. * no neurological or circulatory disease. * no additional exercise or treatment during the study. * no induced fatigue before the experiment. * physically active individual (defined as performing at least 150-300 minutes of moderate activity or 75-150 minutes of vigorous activity per week for at least 6 months). exclusion criteria: * acute soft tissue injury to the upper extremity in the past month. * allergy to nmt or similar drugs. * history of surgical procedures on the upper extremities. * functional impairment of vision or vestibular sensation. * frequent use of neuromuscular taping on the upper extremities. * analgesic intervention for musculoskeletal pain in the past 3 weeks. * participation in a physical therapy rehabilitation program in the past 3 months. * serious physical injuries that limit the ability to perform these procedures.
burden comorbidities and transcatheter aortic valve implantation

Conditions: Symptomatic Severe Aortic Valve Stenosis in Older Patients

Summary: the aim of the study is to determine whether the burden of comorbidities measured by cirs-g (cumulative illness rate scale) is associated with a non-amelioration of the health related quality of life measured by questionnaire called "sf-36", six months after a transcatheter aortic valve replacement in older patients. during the comprehensive geriatric assessment realized before the valve implantation, the following data are recorded and their impact of the health related quality of life will also be analysed: comorbidity, age, depression, functional status, the cognitive impairment and malnutrition.


Eligibility criteria:
inclusion criteria: * patients aged 75 years and older * patients referred for a transcatheter aortic valve implantation * patients who have a comprehensive geriatric assessment realized during the three months before the valve implantation * patients who provide informed written consent exclusion criteria: * patients who refuse the study * patients with a legal guardian

Keywords: aortic valve stenosis quality of life burden co morbidities transcatheter aortic valve implantation geriatric assessment
pilot clinical trial of idracare® in moderate to severe symptoms of vulvovaginal atrophy

Conditions: Vulvovaginal Atrophy

Summary: pilot clinical trial on the efficacy and safety of idracare® in moderate to severe symptoms of vulvovaginal atrophy. to assess the efficacy and safety of idracare® in the treatment of symptoms of avv (dryness and / or dyspareunia) associated with menopause.

pilot clinical trial on the efficacy and safety of idracare® in moderate to severe symptoms of vulvovaginal atrophy. to assess the efficacy and safety of idracare® in the treatment of symptoms of avv (dryness and / or dyspareunia) associated with menopause. open study with only one arm. the study has a total duration per patient of 3 months: initial visit (v1), a follow-up visit (v2) after 4 weeks of treatment and a final visit (v3) after 12 weeks of treatment.

Eligibility criteria:
inclusion criteria: * women who attend medical centers, either for a visit related to vulvovaginal atrophy (vva) or for any other reason for consultation, with symptoms of vva (dryness and / or dyspareunia) of moderate or severe intensity (score 2-3 on the likert scale). * women between the ages of 40 and 65, inclusive, in the peri- or postmenopausal period. * women are able to understand and sign the informed consent after the nature of the study has been fully explained to them. exclusion criteria: * pregnant or immediate postpartum patients (up to 40 days). * formal contraindication for the use of the product, such as hypersensitivity to any of the components of the study treatment. * use of any other experimental drug or device during the 30 days prior to screening. * use of topical antibiotics or antifungals applied vaginally in the two weeks prior to the initial visit. * use of contraceptives for vaginal application. * decompensated chronic diseases (diabetes, epilepsy, high blood pressure, etc.) * undiagnosed abnormal genital bleeding or presence of vaginal lesion. * active genitourinary infections at the time of inclusion or in the 15 days prior to inclusion in the study. * impossibility, at the discretion of the researcher, to comply with the requirements of the study, either due to follow-up problems, or due to their psychophysical characteristics.
an efficacy study comparing symbicort® pressurised metered dose inhaler (pmdi) with budesonide hydrofluoroalkanes (hfa) pmdi, in hispanic subjects with ics dependent asthma

Conditions: Asthma

Summary: the purpose of this study is to determine the effectiveness and safety of symbicort® pmdi (a medication approved by the food and drug administration(fda)) in the hispanic population.


Eligibility criteria:
inclusion criteria: * male or female, hispanic (self-reported), \> 12 years of age * moderate to severe asthma requiring treatment with an inhaled corticosteroid * diagnosis of asthma for at least 6 months exclusion criteria: * subjects requiring treatment with systemic corticosteroids (e.g., oral, parenteral, ocular) * any significant disease or disorder that may jeopardize a subject's safety

Keywords: moderate asthma severe asthma
autonomic activity during nap under hypoxia

Conditions: Hypoxia; Sleep; Healthy

Summary: sleeping under hypoxic conditions can impair cognition and autonomic nervous activity. a short daytime nap can modify these changes. here we propose a randomized, cross-over study to evaluate the heart rate variability during a 90 min nap in a normobaric hypoxic chamber. in addition, we will investigate sleep architecture, vigilance, attention and memory.


Eligibility criteria:
inclusion criteria: * men and women * age 25-45 years * bmi 20 - 28 kg/m\^2 exclusion criteria: * severe, manifest illnesses in need of treatment * postoperative phases * acute and chronic infections * sleep disorders such as sleep apnea, insomnia or somnolence * altitude exposure (\> 2500 m asl) within 6 months before enrollment * regular migraines * smoking * athletes * significant weight change within 1 month before enrollment * inability to understand significance and scope of the study * drug or alcohol abuse

Keywords: hypoxia sleep heart rate variability sleep architecture
effectiveness, safety, adherence, and health-related quality of life in hiv-1 infected adults receiving bictegravir/ emtricitabine/tenofovir alafenamide (b/f/taf)

Conditions: HIV-1-infection

Summary: the primary objective of this study is to evaluate hiv-1 rna suppression, defined as hiv-1 rna \< 50 copies/ml, at 12 months after initiating or switching to bictegravir/ emtricitabine/tenofovir alafenamide (b/f/taf).


Eligibility criteria:
inclusion criteria: * hiv-1 infection * signed informed consent * initiating treatment with b/f/taf exclusion criteria: * participation in any interventional clinical trial
everolimus in combination with cyclosporine microemulsion in de novo renal transplant recipients

Conditions: Transplantation Infection

Summary: the purpose of this study was to allow the continuation of everolimus treatment in patients who have completed the core study (nct00170885) and to collect long-term safety, tolerability, and efficacy data in a group of patients treated with the upper everolimus target levels plus very low dose cyclosporin in comparison with the standard everolimus target levels plus low dose cyclosporin in patients with renal transplantation.


Eligibility criteria:
inclusion criteria: * patients with functioning graft who had completed the 6-month treatment period of core study * patients who were receiving treatment with either everolimus and cyclosporin at the end of the core study * patients who signed the informed consent of the present study extension exclusion criteria: - women who were pregnant, lactating or who wished to became pregnant. other protocol-defined inclusion/exclusion criteria applied to the study.

Keywords: immunosuppression kidney transplantation everolimus safety
the hemodynamic effects of pacap38 after glibenclamide administration in healthy volunteers

Conditions: Migraine; Headache; Pain

Summary: to investigate the hemodynamic effects of pacap38 after glibenclamide administration.

22 healthy participants will randomly be allocated to receive pacap38 infusion followed by glibenclamide or placebo on two different days. the aim of the study is to investigate the vascular effect of pacap38 after glibenclamide administration. repeated measurements covering the arteria radialis (ra), superficial temporal artery (sta) and middle cerebral artery (mca) before and after pacap38 infusion and glibenclamide/placebo administration

Eligibility criteria:
inclusion criteria: * healthy volunteers of both sexes. * 18-60 years. * 50-100 kg. * women of childbearing age must use adequate contraception exclusion criteria: * a history of serious somatic or psychiatric disease * migraine or any other type of headache (except episodic tension-type headache less than 5 days per month) * daily intake of any medication except contraceptives

Keywords: glyburide physiological effects of drugs hypoglycemic agents
racial variation in ace--genetic and physiologic bases

Conditions: Cardiovascular Diseases; Heart Diseases; Hypertension

Summary: to determine whether differences in the activity of the renin-angiotensin and bradykinin systems are involved in the pathogenesis of blood pressure variation in african americans.

background: each year, more than 40,000 new patients require treatment for end stage renal disease, a condition which is 4-fold higher among african americans than caucasians. trials of angiotensin converting enzyme inhibitors (aceis) in caucasians support a role of the renin-angiotensin system in the pathogenesis of glomerulosclerosis. yet, despite the high prevalence of nephropathy among african americans, blacks have been under-represented in studies in aceis. data from our laboratory suggest that the renal effects of acei may differ in african americans. african americans are resistant to the anti-hypertensive effects of acei and, thus, may be resistant to the renoprotective effects as well. the ace deletion allele, a variant associated with increased ace activity and progression of renal diseases, is increased in frequency in african americans, while the frequency of the ang at1 receptor c allele, a variant associated with antihypertensive responsiveness to acei is decreased. moreover, african americans exhibit decreased sensitivity to ang i and increased sensitivity to bradykinin. taken together, these data suggest the hypothesis that ace activity is increased in african americans, leading to decreased bradykinin levels ( and receptor sensitization) and increased tissue ang ii (and receptor desensitization). design narrative: the study tests the hypothesis that ace activity is increased in african americans, leading to decreased bradykinin levels (and receptor sensitization) and increased tissue ang ii (and receptor desensitization). the effects of race, hypertension and ace insertion/deletion genotype on ace activity will be determined, as measured by the pressor and renal vasoconstrictor responses to ang i and ang ii and the vasodilator response to bradykinin. specific bradykinin and angiotensin receptor antagonists will be used to determine the relative contribution of increased bradykinin and decreased angiotensin ii to the renal hemodynamic effects of aceis in african americans and caucasians.

Eligibility criteria:
no eligibility criteria
efficacy of alendronate versus placebo in the treatment of hiv-associated osteoporosis (anrs120)

Conditions: Osteoporosis; HIV Infections

Summary: osteopenia and osteoporosis are being described more frequently in people with hiv infection. this study will test the efficacy of alendronate in comparison with a placebo after 2 years, in people with primary osteoporosis. people will receive the recommended adequate intake of calcium and vitamin d.

the purposes of this trial are: * to study the efficacy of alendronate in hiv-associated osteoporosis * to measure the prevalence of osteoporosis in hiv patients and to detect risk factors in a large cohort of hiv patients from the screening phase

Eligibility criteria:
inclusion criteria: * non-pregnant * non menopausal women * total femur bmd below -2.5 sd (t score) or lumbar spine bmd below -2.5 sd (t score) or bmd below -1 associated with a vertebral osteoporotic fracture (diminution of vertebral height over 20%) * hiv infection known for at least 5 years * cd4 cell count over 50/mm3 * karnofsky score over or equal to 70 * written informed consent. exclusion criteria: * osteoporosis resulting from a cause other than hiv: vitamin d deficiency (in that case, after receiving high-dose calcium and vitamin d for 1 month, patients will be randomized without a new screening), renal failure, heart failure (nhya class iii or iv), treatment with glucocorticoid at a dose over or equal to 0.5mg/kg/d for 15 days or more at time of inclusion or during the previous 6 months; thyroid or other endocrine disease if untreated for more than 6 months; hypercalciuria * testosterone below normal if treatment is hormonal * bmi below or equal to 18 * severe lung failure * chronic alcohol intoxication * ongoing opportunistic infection * gastric ulcer of disease interfering with oesophageal motility in the previous 3 months * history of treatment for osteoporosis * history of malignancy in the previous 5 years (except skin cancer and kaposi) * cytotoxic chemotherapy or cytokine therapy * liver cirrhosis * breast feeding

Keywords: osteoporosis
changing lifestyles for better health

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this research collaboration between dr. william tamborlane, deputy directory of the yale center for clinical investigation (ycci) and fair haven community health center's (fhchc) diabetes prevention team is to determine the efficacy of an intensive life-style intervention (ili) program that has been developed and implemented at the fhchc to prevent the development of diabetes.

this project is a clinical outcome study that merges the expertise of a senior yale clinical investigator, the clinical and translational research resources of ycci, the clinical and community expertise of the fhchc diabetes team, and the high-need patient population of fhchc. in addition to determining the efficacy and cost-effectiveness of an ili for diabetes prevention in an inner-city community health center setting, this project will evaluate the effectiveness of pooling academic expertise with direct clinical services to disadvantaged, at-risk populations.

Eligibility criteria:
inclusion criteria: in order to be eligible for this study, the following criteria must be met: * subjects must be willing to travel to the clinic for all regularly scheduled study visits, and to the lifestyle intervention program site for the ili (the john martinez school). * subjects must have had a 2 hour 75 gram oral glucose tolerance test (ogtt) with fasting glucose between 100 and 126, or 2 hour glucose between 140 and 200 mg/dl in order to participate in this study within the 4 months prior to enrollment. * willingness to undergo fasting blood testing: homa-ir, fasting lipid profile (including total cholesterol, hdl, ldl cholesterol and triglycerides) at the beginning of the study (if not previously obtained with the ogtt) and repeated at 12 months. * subjects must have no medical contraindications to exercise or dieting. exclusion criteria: * subjects will be excluded from the study if they have diabetes or other serious medical or psychiatric condition that would preclude participation in the ili program. * subjects will be excluded if they are taking medications that potentially cause significant weight gain or weight loss (including prescription medication, over the counter medication, or herbal supplements).. * women who are pregnant or planning to become pregnant will not be enrolled in this study. * any behavioral or psychosocial issue that will interfere with the subject's completion of the program, including an eating disorder will prohibit subjects from participating in this study. * subjects cannot participate if they have concurrent membership in a comprehensive weight management program.

Keywords: diabetes lifestyle intervention
auricular acupuncture for pain relief after ambulatory knee arthroscopy

Conditions: Postoperative Pain

Summary: the aim was to investigate whether auricular acupuncture is superior to sham acupuncture in relief of acute postoperative pain and in reduction of analgesics consumption on demand and their side effects in patients after ambulatory knee arthroscopy


Eligibility criteria:
inclusion criteria: 1. patients with an american society of anesthesiologists physical status of i to ii scheduled for ambulatory knee arthroscopy under general anesthesia. 2. surgery time does not exceed 60 minutes. 3. patients without previous opioid and/or psychiatric medication. 4. patients ranged 16-65 years old. 5. patients able to use visual analogue scale-100 for pain intensity measurement. 6. patients who have given informed consent. exclusion criteria: 1. pregnant or nursing females. 2. recidivist alcoholics and/or patients with history of psychiatric disease. 3. local or systemic infection. 4. age \ 65 years. 5. surgery time more than 60 minutes. 6. inability to use visual analogue scale-100. 7. patients consumed opioid medication before surgery. 8. patients with prosthetic or damaged cardiac valves (s. potential risks) 9. patients who are unable to understand the consent form.

Keywords: acute pain postoperative pain auricular acupuncture