Kornimate/medical-research-clean huggingface dataset:
nasal high flow in bariatric surgery

Conditions: Morbid Obesity

Summary: high frequency nasal cannula (hfnc) provides an inspiration o2 fraction of 21-1% and it has a minimal dead space and can be well tolerated due to humidified air. group i patients will be applied hfnc before and after bariatric surgery, group ii patients will be applied a constant o2 concentration via face mask. oxygen pressure, oxygen saturation, carbon dioxide, respiration frequency, forced vital capacity will be measured before and after surgery.

morbid obese patients are prone to atelectasis and hypoxemia after bariatric surgery. high frequency nasal cannula (hfnc) provides an inspiration o2 fraction of 21-1% and it has a minimal dead space and can be well tolerated due to humidified air. it provides 5-7 cm h2o positive end expiratory pressure to the airways and may prevent atelectasis. in the preoperative room, forced vital capacity, peripheral oxygen saturation (spo2), respiratory frequency, heart rate (hr), blood pressure (bp), carbon dioxide, oxygen pressure and carbon dioxide partial pressure values in blood gas analysis will be recorded. we will apply hfnc in the preoperative and postoperative period to group i patients, while applying a constant o2 concentration to group ii patients. after appliying hfnc for two hours in group i patients and o2 via face mask in group ii patients measurements will be repeated. during surgery, similar mechanical ventilation parameters will be applied to the patients. after the operation group i patients will be applied hfnc, while group ii patients will be applied o2 via face mask in the recovery room for two hours. measurements will be repeated. primary end point of the study is the association between oxygen pressure, carbon dioxide partial pressure values among preoperative before and after hfnc and o2 and postoperative times.

Eligibility criteria:
inclusion criteria: * patients with a body mass index of 40-55 kg/m2 * american society of anesthesiologists score ii-iii * patients undergoing laparoscopic sleeve gastrectomy or one anastomosis gastric bypass exclusion criteria: * obstructive sleep apnea syndrome * using a non invasive mechanical ventilation device preoperatively * patients whoo will predicted to postanesthesia care unit admission postoperatively

Keywords: morbid obesity bariatric surgery high frequency nasal cannula oxygenation
next-day residual effects of gabapentin, diphenhydramine and triazolam on simulated driving performance in normal volunteers

Conditions: Healthy

Summary: this study will examine the next-day residual effects of a nighttime dose of gabapentin 250 mg, diphenhydramine citrate 76 mg and triazolam 0.5 mg compared to placebo and each other on simulated driving performance in normal volunteer subjects. it will also examine other measures of next-day performance and next-day sleepiness.


Eligibility criteria:
inclusion criteria: * healthy males and females of non-childbearing potential, 25-55 years of age * valid driver's license exclusion criteria: * psychiatric disorder * recent history of clinically significant neurological disorder, such as seizures, stroke, multiple sclerosis, or head trauma * recent histroy or current treatment for sleep disorder

Keywords: sleeplessness
a study of isoprinosine in patients with lymph node disease

Conditions: Lymphatic Disease; HIV Infections

Summary: the objectives of this study are to determine the effects of isoprinosine in patients diagnosed as having unexplained generalized lymphadenopathy. variables to be examined will include: signs and symptoms: * lymphadenopathy. * fever. * weight loss. * occurrence of opportunistic infections. cell-mediated immune system parameters: * t-helper cell (okt4) numbers and proportions. * t-suppressor cell (okt8) numbers and proportions. * natural killer (nk) cell activity. * lymphocyte blastogenic response to phytohemagglutinin (pha). * lymphocyte blastogenic response to pokeweed mitogen (pwm). * immunoglobulin (igg, iga, igm, ige, igd) profile. * circulating immune complexes. infections characteristically associated with aids, such as candida albicans, pneumocystis carinii pneumonia, cytomegalovirus, herpes simplex, cryptococcus, histoplasma, toxoplasma, cryptosporidium, mycobacterium avium- intracellulare, legionella, and isospora. safety parameters: * blood chemistry including serum uric acid (purposea-12). * complete blood count (cbc). * platelet count.


Eligibility criteria:
exclusion criteria co-existing condition: patients with a history of gout, uric acid urolithiasis, uric acid nephrolithiasis, renal dysfunction, or gastric ulceration are excluded. concurrent medication: excluded: * systemic corticosteroids. * cytotoxic immunosuppressive agents. * radiotherapy. critically ill patients or those with cdc-defined aids are excluded. prior medication: excluded within 1 month of study entry: * immunotherapy. patients with persistent generalized lymphadenopathy (pgl).

Keywords: inosine pranobex aids-related complex
effect of 4-week dihydrocapsiate ingestion on resting metabolic rate

Conditions: Obesity; Weight

Summary: a 4 week intake of drug to find a natural substance that may modify energy balance and may enhance health in combination with lifestyle changes with possible decrease in body weight.

this study is a double-blind, placebo-controlled, single center, randomized, parallel arm clinical trial to test the impact of dihydrocapsiate (placebo, 3 and 9 mg/d) ingested for 4 weeks on resting metabolic rate and fat oxidation measured by indirect calorimetry.

Eligibility criteria:
inclusion criteria: * men between 20-60 years old * healthy as assessed by medical history and standard medical exam * weight-stable * body mass index of 25 to 34.9 kg/m2 * non-smoker * sedentary lifestyle: not being physically active grater than 3 days/week for 20 min each time for the previous 6 months, and not participating in regular resistance exercise. exclusion criteria: * subjects enrolled in a diet to increase or decrease body weight * special diet or food aversiions to common foods * has allergy to chilli pepper * eating chilli peppers on a daily basis * usually consuming more than 2 cups of tea or coffee/day * usually consuming more than 4 cans of caffeinated soft drinks a day * usually consuming more than 3 standard alcohol drinks/day * regular use of medications (weight loss drugs, drugs affecting energy metabolism, drugs for depression) * usual intake of illicit substances * claustrophobia * participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study

Keywords: thermogenesis respiratory quotient fat oxidation
a multicomponent intervention to address gender-based violence in hiv

Conditions: Acceptability of Health Care; HIV Primary Infection

Summary: this project seeks to adapt and pilot a trauma-informed combination intervention named 'kickin' it with the gurlz' that was designed with, for, and by transgender women of color to improve hiv prevention continuum outcomes. the intervention components include a violence and gender affirmation screening tool, a peer-led adaptation of seeking safety, and individual-level peer navigation sessions. we will examine the feasibility, acceptability, and preliminary promise of the multicomponent by conducting a one-arm pilot with 30 transgender women of color who have a history of trauma. participants will complete baseline, immediate post-intervention, and 3-month follow up assessments.

this project seeks to evaluate the feasibility and acceptability of the trauma-informed combination prevention intervention to improve hiv prevention continuum outcomes including the development of community-informed strategies for subsequent rcts. we will conduct a one-arm pilot of the adapted multicomponent trauma-informed intervention named "kickin it with the gurlz." we will collect feasibility and acceptability data related to identifying, recruiting, enrolling, intervening with, and retaining participants (i.e. recruitment length, screening procedures, feasibility of conducting sessions, intervention acceptability, retention rates, feasibility of verifying self-reported and medical chart review data on prep use, and exit interviews with participants and staff at program conclusion). we will recruit 30 participants into the pilot study. participants will complete baseline, end of program, and 3-month post-intervention follow-up surveys. exit interviews and interviews with key stakeholders will identify strategies for implementing trauma-informed hiv prevention efficacy trials with transgender women of color within close-knit communities, such as acceptable and feasible control conditions, acceptable and feasible violence and gender affirmation screening, biomedical confirmation methods, contamination concerns, and potential changes needed within existing health care systems.

Eligibility criteria:
inclusion criteria: * at least 18 years old * assigned male at birth; identifies as female, transgender woman, or another feminine gender identity * self-identifies as a person of color (any racial/ethnic identity except non-hispanic white) * self-reports as hiv-negative or unknown hiv status * history of trauma (i.e., endorses at least 2 items on the adapted trauma history screener which includes ipv and experiencing or witnessing other forms of violence for transgender women * living or willing to travel to detroit * english-speaking * willing and able to provide informed consent. exclusion criteria: • evidence of severe cognitive impairment or active psychosis that may impede ability to provide fully informed consent
effect of liraglutide on weight loss in patients who have undergone revisional bariatric surgeries.

Conditions: Morbid Obesity

Summary: our primary objective is to assess the effect of liraglutide on weight loss in patients who have undergone secondary bariatric surgeries. we set out to assess if liraglutide is a viable option to augment weight loss in said category.


Eligibility criteria:
inclusion criteria: * undergone primary bariatric surgery * need secondary bariatric surgery due to either weight regain (regained weight to have bmi \> 35) or medical associated diseases exclusion criteria: * prior use of glp-1 agonist * past history of pancreatitis * personal or family history of medullary thyroid cancer * pregnancy or lactation * acute coronary syndrome * hepatic or renal dysfunction * active malignancy

Keywords: liraglutide morbid obesity secondary bariatric surgery revisional bariatric surgery
the effects of topical corticosteroid use on insulin sensitivity and bone turnover

Conditions: Atopic Dermatitis; Atopic Eczema

Summary: the investigators believe that the emerging epidemiological evidence connecting topical use of corticosteroids to the development of type 2 diabetes and osteoporosis point to potentially massive, yet clinically unacknowledged problems associated with topical corticosteroid treatment. using state-of-the-art methodology, the present study will delineate the impact of topical corticosteroid use on insulin sensitivity and bone turnover markers in patients with atopic dermatitis and, thus, provide important data that may have implications for millions of people using topical corticosteroids.


Eligibility criteria:
inclusion criteria * age 18-75 years * ad according to the hanifin and rajka criteria24 * ad for at least 3 years * bmi ≤ 30 kg/m2 * haemoglobin a1c (hba1c) ≤ 42 mmol/mol (6.0%) * normal haemoglobin (men: 8.3-10.5 mmol/l and women 7.3-9.5 mmol/l. a 5% deviation will be allowed if the patient besides this is healthy) * informed consent * in general patients should not be diagnosed with diseases that may affect or be affected by the study/treatment (evaluated by a doctor) (such as untreated skin infections, acne vulgaris (beside face region), a skin barrier defect, such as netherton's syndrome, lamellar ichthyosis, generalized erythroderma or cutaneous graft versus host disease, congenital or acquired immunodeficiencies or in patients on therapy that cause immunosuppression, and protopic ointment should not be applied to lesions that are considered to be potentially malignant or pre-malignant. further patients should not suffer from kidney or liver disease/insufficiency. see the spc for protopic and betnovate.) exclusion criteria * diagnosed diabetes mellitus * other chronic inflammatory diseases (including but not limited to rheumatoid arthritis, inflammatory bowel disease etc) beside ad and non-treatment demanding rhinitis or asthma (treated within the last 4 weeks) * pregnancy (a urine test will be done at every visit and birth control is required, see below\*) * breast feeding * treatment with drugs that might affect the glucose metabolism beside tcs within a month prior to the project * daily smoker, alcoholic, or drug abuser * hypersensitivity to protopic or betnovate

Keywords: topical corticosteroids topical calcineurin inhibitors
safety and efficacy of idp-122 in the treatment of participants with plaque psoriasis

Conditions: Plaque Psoriasis

Summary: this study is to evaluate the safety and efficacy of a topical lotion when applied once daily to adult participants with moderate to severe plaque psoriasis (defined as an investigator's global assessment \[iga\] score of 3 or 4).

the objective of the study is to evaluate the safety and efficacy of topical idp-122 lotion when applied once daily to adult participants with moderate to severe plaque psoriasis. the intent of the study is specifically to evaluate the safety and efficacy of a once daily application of idp-122 lotion in comparison with vehicle.

Eligibility criteria:
inclusion criteria: * male or female, of any race, at least 18 years of age (inclusive). * freely provides both verbal and written informed consent. * has an area of plaque psoriasis appropriate for topical treatment that covers a body surface area (bsa) of at least 3%, but no more than 12%. the face, scalp, palms, soles, axillae, and intertriginous areas are to be excluded in this calculation. * is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study. * has a clinical diagnosis of psoriasis at the baseline visit with an iga score of 3 or 4. (the face, scalp, palms, soles, axillae and intertriginous areas are to be excluded in this assessment). exclusion criteria: * has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular psoriasis, as determined by the investigator. * presents with psoriasis that was treated with prescription medication and failed to respond to treatment, even partially or temporarily, as determined by the investigator. * presents with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the investigator. * is pregnant, nursing an infant, or planning a pregnancy during the study period. * has received treatment with any investigational drug or device within 60 days or 5 drug half-lives (whichever is longer) prior to the baseline visit or is concurrently participating in another clinical study with an investigational drug or device.
long-term, open-label, flexible-dose, extension study of vortioxetine in child and adolescent participants with major depressive disorder (mdd) from 7 to 18 years of age

Conditions: Depressive Disorder, Major

Summary: evaluation of the long-term safety and tolerability of vortioxetine in child and adolescent participants with a diagnostic and statistical manual of mental disorders, 5th edition (dsm-5™) diagnosis of mdd.


Eligibility criteria:
inclusion criteria: * the participant is a male or female child aged ≥7 and \<12 years or adolescent aged ≥12 and ≤18 years in the lead-in study (12709a and 12710a). * the participant must have completed study 12709a or 12710a (visit 12, completion visit) immediately prior to enrolment into this extension study. * the participant had a primary diagnosis of mdd at entry in study 12709a or 12710a, diagnosed according to dsm-5™. * the participant is indicated for long-term treatment with vortioxetine according to the clinical opinion of the investigator. * for participants aged ≥7 and ≤17 years at the baseline visit; the participant is able to understand the informed assent form, and parent(s)/legal representative(s) are able to read and understand the informed consent form. * for participants who turned 18 years during the lead-in study 12710a; the participant has signed the informed consent form. exclusion criteria: * the participant has been diagnosed with another psychiatric disorder (for example mania, bipolar disorder, schizophrenia or any psychotic disorder) during study 12709a or 12710a. * the participant has an attention-deficit/hyperactivity disorder (adhd) that requires a pharmacological treatment other than a stimulant medication. other protocol-defined inclusion and exclusion criteria may apply

Keywords: adolescent children
laparoscopic low pressure colorectal surgery

Conditions: Malignant or Benign Pathology

Summary: laparoscopy by its mini-invasive character has revolutionized abdominal and colorectal surgery but certain limitations remains (post-operative pain due to pneumoperitoneum, pneumoperitoneum stability, visibility during bleeding, smoke evacuation). the medical device for continuous pressure insufflation during laparoscopic procedures airseal® would allow the maintenance of pneumoperitoneum at a lower pressure. the stable low pressure (7mmhg) is described in the literature for 15 years as the best way to reduce scapular pain, but until the marketing of airseal, working at 7mmhg was not possible because the space of work was not stable. moreover, this device makes it possible to obtain a better vision because of the evacuation of the fumes potentially leading to a reduction in the operating time.

this research focuses on a medical device that allows the surgeon to perform the surgical procedure at a lower pressure than usual. the main objective of this study is to compare the duration of hospitalization of patients with laparoscopic colectomy at low pressure (5-7 mmhg) versus standard pressure (12-15 mmhg) it is a prospective randomized monocentric double blind study

Eligibility criteria:
inclusion criteria: * age ≥ 18 * colonic resection (right or left) performed for benign or malignant pathology * laparoscopic procedure * informed consent signed * social insurance exclusion criteria: * laparotomy procedure * associated resection (except appendectomy or liver biopsy * emergency procedure * pelvic sepsis * pregnant or breast-feeding woman. * persons deprived of liberty or under guardianship * impossibility for compliance to follow-up

Keywords: low pressure laparoscopy colectomy pneumoperitoneum airseal
pain management with pecfent in the prevention of pain induced by position in radiotherapy

Conditions: Bone Metastasis

Summary: the clinical trial is a stage 3 study to determine the role of fentanyl transmucosal in the prevention of pain induced by mobilization in patients receiving a bone metastasis radiation for bone metastasis irradiations

participation to the trial will be proposed to the patient by the investigator in charge of the analgesic irradiation during the preliminary scanner session that will be held before radiotherapy session(s). patients with a vas≤ 3 will be excluded. pecfent and placebo will be delivered by archimedes pharma when starting the radiotherapy session(s) (2 days after the preliminary scanner session), the medic will collect the patient signed informed consent, will deliver the treatment 1 dose of fentanyl transmucosal (pecfent® ) 100µg in naive patients or 1 dose of pecfent® 200µg in patient with a stable opioid background pain treatment or placebo) and will collect pain intensity value with a patient vas collected before and at the end of the radiotherapy session. finally patient \& radiotherapists global satisfaction will be collected an assessment a week the end of the radiotherapy session will be assessed by investigator consisting in a patient global satisfaction study follow up: patients will receive a phone call a week after the radiotherapy session to collect patient global satisfaction score related with the global management of the radiotherapy session

Eligibility criteria:
inclusion criteria: * male or female * more than 18 years old * proven histological cancer with bone metastasis * signedinform consent form * patient with pain assed as vas superior to 3 when positioning the patient in the preliminary scanner session exclusion criteria: * vas\>3 before radiotherapy treatment (establishment of an appropriate analgesic treatment) (session * any sao treatment on going * pregnant or lactating woman * hypersensitivity or safety issues to any opioïd treatment * poor nasal mucosa (defined on clinical doctor assessment) * severe obstructive lung conditions or respiratory depression * renal insufficiency with creatinine clearance inferior to 45 ml/min * hepatic insufficiency * patient misunderstanding of the content and objective of the trial * patient under supervision or guardianship * sao intake 4 hours before the radiotherapy session * patient participating to any other pain management trial * morphine pump usage

Keywords: bone metastasis, radiotherapy, pain, prevention
a study of the efficacy and safety of a 3-month treatment course of ulipristal acetate for the treatment of abnormal uterine bleeding associated with leiomyomas

Conditions: Leiomyoma; Uterine Hemorrhage

Summary: this study will evaluate the superiority of ulipristal acetate versus placebo for the treatment of abnormal uterine bleeding associated with uterine fibroids


Eligibility criteria:
inclusion criteria: * pre-menopausal women, 18-50 years, inclusive. * cyclic abnormal uterine bleeding (heavy or prolonged). * menstrual blood loss (mbl) of ≥ 80 ml as measured by the alkaline hematin method in the first 8 days of menses. * minimum of one discrete leiomyoma observable by transvaginal ultrasound. * endometrial biopsy without evidence of malignancy or atypical or non-atypical hyperplasia exclusion criteria: * history of uterine surgery that would interfere with the study endpoints. * known coagulation disorder including bleeding disorder or clotting disorder. * history of, or current uterine, cervix, ovarian, or breast cancer. * alanine transaminase (alt), aspartate transaminase (ast), alkaline phosphatase (alp), or total bilirubin two times or greater than the upper limit of normal rang
phytoestrogens as an alternative to estradiol in ovulation induction in pcos

Conditions: Polycystic Ovaries

Summary: prospective study conducted on 150 women with polycystic ovarian syndrome (pcos) were randomly divided into 3 groups: group i (50 women) received clomiphene citrate (cc) only 50 mg orally every 8 hours started from cycle day 3 for 5 days, group ii (50 women) received 2mg estradiol valerate daily from cycle day 7 - 11 in addition to cc and group iii (50 women) received phytoestrogen (20mg of cimifuga racemosa from day 1- 12) in addition to cc.

prospective study conducted on 150 women with pcos were randomly divided into 3 groups: group i (50 women) received cc only50 mg orally every 8 hours started from cycle day 3 for 5 days, group ii (50 women) received 2mg estradiol valerate daily from cycle day 7 - 11 in addition to cc and group iii (50 women) received phytoestrogen (20mg of cimifuga racemosa from day 1- 12) in addition to cc.

Eligibility criteria:
inclusion criteria: women with both 1ry and 2ry infertility were included. all women were between 20 and 37 years old. exclusion criteria: women with endocrinological abnormalities as thyroid dysfunction or abnormal prolactin levels, those with hypothalamic or pituitary dysfunctions evaluated by low gonadotropin level, other causes of infertility as tubal factor evaluated by hsg or laparoscopy, abnormal uterine cavity evaluated by sonohystrography or hysteroscopy and male factor evaluated by semen analysis. women with ovarian cysts were also excluded from the study

Keywords: pcos phytoestrogens ovulation induction