Kornimate/medical-research-clean huggingface dataset:
study of transdermal testosterone patches in naturally menopausal women with low libido

Conditions: Hypoactive Sexual Desire Disorder

Summary: this study is designed to evaluate efficacy and safety of a testosterone patch as treatment for low libido in naturally menopausal women who are taking estrogen or estrogen/progestin therapy.

naturally menopausal women with hypoactive sexual desire disorder (hsdd) were randomized into a 52-week, multicenter, double-blind (db), parallel-group, placebo-controlled study. patients were stratified based on presence/absence of uterus and randomized to receive placebo or testosterone transdermal system. patients had to maintain a stable dose of estrogen/progestin throughout the study. patients who completed the first 52 weeks of the study were given the opportunity to participate in year 2-4 open-label (active treatment) study extension which was added to the protocol by amendment. safety was assessed by adverse events, lipids, serum chemistry with hepatic, renal and carbohydrate metabois in evaluation, coagulation testing, and hermatology. physical exam including clinical assessments of facial hair and acne were monitored.

Eligibility criteria:
inclusion criteria: eligible women must: 1. be 40-70 years old and in generally good health 2. be post-menopausal with no spontaneous periods for 1 year 3. be receiving a stable dose of hormone replacement therapy for at least 3 months prior to screening with the intention of maintaining that regimen. 4. be, in her own judgment, in a stable, monogamous sexual relationship that is perceived to be secure and communicative, for at least one year prior to study entry 5. meet the criteria for having hypoactive sexual desire disorder exclusion criteria: eligible women must not: 1. have received androgen therapy at any time during the past 3 months (during the past 7 months if therapy was an investigational implantable product) 2. be experiencing any chronic or acute life stress relating to any major life change 3. be experiencing depression and/or receiving medication for such illness or disorder 4. have current severe skin problems (such as severe or cystic acne) or allergy to adhesives (like the ones in bandages) 5. have had a major illness, active gall bladder disease, or gynecological or breast surgery within the last 6 months 6. have a history of breast, endometrial, or other gynecological cancer at any time before study participation or other cancer within the last 5 years 7. have diabetes, a history of cerebrovascular disease, thromboembolic disorders, heart attack, or angina at any time before study participation or thrombophlebitis within the last 5 years 8. have abnormal laboratory test results upon initial screening for this study 9. have previously participated in a clinical trial within 30 days or received an investigational medication within 30 days

Keywords: natural menopause hsdd
efficacy at 24 weeks and safety, tolerability and long term efficacy up to 2 years of secukinumab (ain457) in patients with active rheumatoid arthritis and an inadequate response to anti-tnfα agents

Conditions: Rheumatoid Arthritis

Summary: the core and extension studies assessed the safety and efficacy of secukinumab when added to a background therapy in patients with active rheumatoid arthritis who are intolerant to or have had an inadequate response to anti-tnf-α agents. patients received either secukinumab, placebo. the core study was completed. however, the extension study was terminated early (unrelated to safety) due to the results of study ain457f2309, which indicated the efficacy of ain457 was not comparable to the currently available ra treatment, abatacept, thus leading to closing of the ain457 ra program.

cain457f2302 (core study): completed sep 9 2015 cain457f2302e1 (extension study): terminated early may 26 2015, ((unrelated to safety) due to the results of study ain457f2309, which indicated the efficacy of ain457 was not comparable to the currently available ra treatment, abatacept, thus leading to closing of the ain457 ra program.

Eligibility criteria:
inclusion criteria: * male or non-pregnant, non-lactating female patients * presence of ra classified by american college of rheumatology (acr) 2010 revised criteria for at least 3 months before screening * at baseline: disease activity criteria defined by ≥ 6 tender joints out of 68 and ≥6 swollen joints out of 66 with at least 1 of the following at screening: * anti-cyclic citrullinated peptide (ccp) antibodies positive or rheumatoid factor positive and with at least 1 of the following at screening: * high sensitivity c-reactive protein (hscrp) ≥ 10 mg/l or erythrocyte sedimentation rate (esr) ≥ 28 mm/1st hr * patients must have been taking at least one anti-tnf-α agent given at an approved dose for at least 3 months before randomization and have experienced an inadequate response to treatment or have been intolerant to at least one administration of an anti-tnf-α agent * patients must be taking mtx for at least 3 months before randomization and have to be on a stable dose at least 4 weeks before randomization (7.5 to 25 mg/week for japan only: 6 to 25 mg/week) exclusion criteria: * chest x-ray with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician ra patients functional status class iv according to the acr 1991 revised criteria * patients who have ever received biologic immunomodulating agents except for those targeting tnfα * previous treatment with any cell-depleting therapies including but not limited to anti-cd20, investigational agents (e.g., campath, anti-cd4, anti-cd5, anti-cd3, anti-cd19) * other protocol-defined inclusion/exclusion criteria may apply.

Keywords: rheumatoid arthritis ra acr inflammatory joints
effect of preoperative steroid in total knee arthroplasty

Conditions: Arthropathy of Knee

Summary: detect the effect of preoperative steroid injection in total knee arthroplasty on post operative: 1. pain 2. oedema 3. nausea and vomiting 4. quadriceps power 5. knee flexion 6. wound complications

total knee arthroplasty has been identified as one of the most effective surgeries for knee arthritis. many patients experience moderate to severe pain during the early postoperative period, as the surgery involves extensive bone resection and postsurgical serum levels of cytokine interleukin-6 and c-reactive protein may be elevated.furthermore, many patients suffer postoperative nausea and vomiting after total knee arthroplasty . the inflammatory response after tka is pronounced and a result of cumulative effects of anaesthesia and mechanical stress . inadequate management of postoperative pain is relevant with a series of undesirable effects, including progression to a persistent pain, delayed functional recovery, increased the economic burden and patient dissatisfaction. steroids may be associated with decreased levels of interleukin-6 and c reactive protein and may, thus, relieve the pain associated with surgery. dexamethasone is a long-acting glucocorticoid that has been reported to inhibit peripheral phospholipase a, which decreases the pain-aggravating agents from the cyclooxygenase and lipoxygenase pathways . in addition, it reduces postoperative nausea and vomiting by exerting a central antiemetic effect by inhibiting prostaglandin synthesis and the release of endogenous opioids\[5\] . some studies also reported potential adverse events, such as infection .

Eligibility criteria:
inclusion criteria: 1. any patient scheduled for primary total knee replacement arthroplasty exclusion criteria: 1. diabetic patients 2. rheumatoid arthritis patients 3. patients on regular steroid therapy 4. patients refused to be enrolled in the study
rehabilitation with patterned electrical neuromuscular stimulation for patients with patellofemoral pain

Conditions: Patellofemoral Pain Syndrome

Summary: this is a randomized controlled trial (rct) regarding the conservative treatment of patellofemoral pain (pfp) with an impairment based rehabilitation program. those with pfp can have a variety of impairments, such as knee and hip muscle weakness, poor movement patterns, weak core activation and muscle tightness. several recent rct trials have looked at treating single impairments, but to date no rct have address individualized patient impairments during a rehabilitation program. abnormal muscle firing patterns have also been identified during functional tasks; such as jogging, stair climbing, and performing a single leg squat. conflicting studies have produced changes to the quadriceps and hip muscle firing patterns with those with pfp. the abnormal activation patterns has been suggested to be why strengthening programs alone do not improve movement patterns during functional tasks for those with pfp. patterned electrical neuromuscular stimulation (pens) is a novel form of electrical stimulation that replicates proper firing patterns based off healthy electromyography patterns. the purpose of the study is to investigate the benefits of pens with a impairment based rehabilitation program for the treatment of pfp. the rationale for this investigation is to assess the benefits of pens with therapeutic exercise at improving altered firing patterns of the lower extremity muscles during functional tasks.


Eligibility criteria:
inclusion criteria: * insidious onset of symptoms * presence of peri- or retro patellar knee pain during at least two of the following functional activities: stair ascent or descent, running, kneeling, squatting, prolonged sitting, jumping * pain for more than 3 months * pain \>3/10 on vas * 85 or less on the anterior knee pain scale exclusion criteria: * previous knee surgery * internal derangement * ligamentous instability * other sources of anterior knee pain(patella tendonitis, osgood schlatter, knee plica, etc) * neurological involvement * any biomedical device * muscular abnormalities * currently pregnant * hypersensitivity to electrical stimulation * active infection over the site of the electrode placement
rural dementia caregiver project

Conditions: Depression; Stress, Psychological; Self Efficacy; Loneliness; Social Isolation; Health Care Utilization; Dementia; Dementia Alzheimers; Dementia of Alzheimer Type; Dementia, Vascular; Dementia Frontal; Dementia, Lewy Body; Dementia, Mixed; Dementia in Parkinsons Disease; Dementia, HIV; Dementia Frontotemporal; Dementia, Multi-Infarct

Summary: these caregivers are a vulnerable group due to their physical isolation and well-documented rural disparities in health care access and quality. many rural dementia caregivers experience serious health consequences due to caregiving responsibilities that can limit their ability to maintain their caregiving role. thus, there is a pressing need for effective, scalable, and accessible programs to support rural dementia caregivers. online programs offer a convenient and readily translatable option for program delivery because they can be accessed by caregivers in the home and at the convenience of the user. building better caregivers is an online 6-week, interactive, small-group self-management, social support, and skills-building workshop developed for caregivers of individuals with alzheimer's disease or related dementia. the investigators will conduct a hybrid effectiveness-implementation randomized controlled trial that will enroll and randomize 640 rural dementia caregivers into two groups: the intervention (workshop) group and the attention control group. caregivers will be recruited throughout the united states. primary outcomes will be caregiver stress and depression symptoms. the investigators hypothesize that stress scores and depression symptoms will be significantly improved at 12 months in the intervention group versus control group. the investigators will also identify key strengths (facilitators) and weaknesses (barriers) of workshop implementation. the investigators will use the re-aim implementation framework and a mixed methods approach to identify implementation characteristics pertinent to both caregivers and rural community organizations. if the building better caregivers workshop is proven to be effective, this research has the potential to open new research horizons, particularly on how to reach and effectively support isolated dementia caregivers in rural areas with an intervention that is scalable, even in low-resourced settings. if the workshop can achieve its goals with rural dementia caregivers, some of those most isolated, it would also be expected to be scalable in other low-resourced settings (e.g., in urban or suburban environments).


Eligibility criteria:
inclusion criteria: * aged 18 years or older * caring for person with dementia * able to read and write in english * able to access the internet * providing care for ≥ 10 hours per week * reporting a minimum stress level of 4 or more on a 10-point scale * living in rural area of united states (self-identify or zip code is a rural urban commuting area codes (ruca) defined rural area) exclusion criteria: * have an anticipated inability to complete the 12-month follow-up (e.g., planned travel)

Keywords: caregiver caregiving
a randomized trial to assess the role of imaging during follow up after radical surgery of high risk melanoma

Conditions: Malignant Melanoma

Summary: it is not known whether radiological assessments during follow up after surgery for high risk melanoma improve survival. since radiological examinations are resource demanding, could inflict worry and cause irradiation exposure it is an important question to address. with the introduction of effective medical treatments for malignant melanoma patients, there is a tendency to introduce radiological assessments despite the lack of evidence.

the patients are randomized 1:1 to routine follow up for 3 years with regular doctors´ appointments according to national guidelines and the same follow up but with the addition of whole body ct or positron emission tomography (pet) scans and blood tests. an interim analysis will be conducted when 1000 patients have been included.

Eligibility criteria:
inclusion criteria: * at least 18 years of age. * radical surgery for cutaneous malignant melanoma (cmm) stage iib-c and iii. * sufficient renal function for i.v. contrast scannings. exclusion criteria: * the patient is assessed as unfit to receive treatment in the case of recurrence. * life-expectancy less than 2 years due to concurrent disease (e.g., cardiac disease, terminal multiple sclerosis, liver cirrhosis). * inability to provide informed consent or refusal to do so. * inability to comply with the control or intense follow-up program. * participation in other clinical trials interfering with the control-program. * existing or previous malignancies within the past 5 years (except for in situ breast and cervical cancer, melanoma in situ and non-melanoma skin cancer). * pregnancy or currently planned pregnancy.

Keywords: malignant melanoma follow up radiology survival
dexmedetomidine affect diabetic patient's glucose metabolism

Conditions: Diabetes

Summary: dexmedetomidine's sedative effect on diabetic patient

dexmedetomidine is a high selective α2 agonist,its sedative and analgesia feature is acclaimed. the pathogenesis of type 2 diabetes mellitus is associated with α2 excessive adrenaline receptors expression. this study is to evaluate whether the use of dexmedetomidine is helpful to diabetic patient through its antisympathetic effect

Eligibility criteria:
inclusion criteria: * age between 40 and 60 * selective epigastrium surgery * in exclusion criteria: * american society of anesthesiology (asa) physical status\>3 * duration of operation \>3 hours * hypovolemia,sinus bradycardia,atrioventricular block,severe hepatic and renal dysfunction,severe cardiac insufficiency

Keywords: dexmedetomidine diabetic glycometabolism sedation
evaluation of clinical outcomes and costs of a lifestyle intervention in obese infertile women

Conditions: Female Infertility; Polycystic Ovary Syndrome; Obesity

Summary: background: obesity increases the risk of polycystic ovary syndrome (pcos), characterized by anovulatory cycles, but it is also associated with reduced fertility even in ovulatory women. moreover, obesity increases the costs of assisted human reproduction (ahr) treatments and reduces their efficacy. in addition to fertility disorders, obesity increases significantly the risks of many complications of pregnancy, delivery and neonatal health. however, a modest loss of 5-10% of total body weight can restore ovulation and improve pregnancy rates. objectives: 1) to design and implement a multidisciplinary program for lifestyle management of obese women, or overweight women with pcos, who seek fertility treatment in a secondary ahr center. 2) to evaluate lifestyle benefits of this program and assess its impact on fertility, pregnancy and neonatal outcomes, as compared to a randomly assigned control group and to similar women seen in tertiary ahr centers. 3) to assess cost per live birth, and other measures of cost-effectiveness, of this program compared to the control group and tertiary ahr centers. 4) to effectively transfer knowledge obtained through these activities to relevant stakeholders in the health care and public health sectors. methods and approach: in order to design the program for lifestyle management of obesity in infertile women, we will gather a committee composed of members of our interdisciplinary research team and relevant collaborators. objectives 2 and 3 - in order to achieve these objectives, 128 obese women (bmi ≥ 30 kg/m²), or overweight women with pcos (bmi ≥ 27 kg/m²), consulting at the chus fertility clinic will be randomized to our lifestyle program, and will suspend fertility treatments for six months, or to standard fertility treatments, which are directly initiated. the results obtained will also be compared to those of women with the same criteria who will consult in 3 tertiary ahr clinics not offering a similar lifestyle management program. impact: this project is very important as it will generate new knowledge about the implementation, impacts and costs of a new lifestyle management program in obese infertile women. our project will obtain valuable data on implementability of such a program; on benefits with regard to lifestyle, fertility and maternal and foetal complications during pregnancy; as well as on reduction in cost per live birth and other cost-effectiveness ratio.


Eligibility criteria:
inclusion criteria: * obese (bmi ≥ 30kg/m2) infertile women * overweight (bmi ≥ 27kg/m2) infertile women with polycystic ovary syndrome exclusion criteria: * women older than 40 years old * women who went through bariatric surgery * women under ivf * women for whome ivf is the only recommended treatment * women who do not speak french

Keywords: body weight female infertility, female/therapy infertility, female/physiopathology obesity/physiopathology polycystic ovary syndrome pregnancy pregnancy outcome weight loss
open label safety study of xerese cream in the treatment of recurrent herpes labialis in children 6-11 years old

Conditions: Herpes Labialis

Summary: to test the safety of xerese (acyclovir and hydrocortisone)cream 5%/1% for the treatment of recurrent cold sores in children ages 6-11yrs after 5 days of treatment.


Eligibility criteria:
inclusion criteria: * male or female, age 6-11 years at time of enrollment * general good health, as judged by the investigator * history of recurrent herpes labialis with at least two (2) recurrences during the last twelve (12) months, as based on interview with the subject or subject's caregiver * agreement to refrain from using other topical medical, over-the counter (otc), or cosmetic products in or around the oral area during the herpes recurrence * agreement to refrain from mechanical disruption of the area affected by herpes labialis during the study recurrence * subjects and their legally acceptable representative(s) must voluntarily sign and date the informed assent (subject) and consent (legally authorized representative). * willingness to comply with all requirements of the study. exclusion criteria: * any evidence of an immunosuppressed state of the subject due to underlying disease (e.g. hiv infection) or concomitant treatment (e.g. cancer chemotherapy) * significant skin conditions that occur in the area typically affected by herpes recurrences, and that would interfere with assessment of lesions such as atopic dermatitis, acne, eczema, psoriasis or chronic vesiculobullous disorders * administration of an investigational drug or within 30 days prior to inclusion, or concurrent participation in another research study * administration of an immunomodulatory agent within the past 30 days * history of immediate hypersensitivity or serum sickness reaction to any nucleoside analog antiviral agent, or to any topical steroid, or to the vehicle * clinically relevant abnormal physical findings at screening which, in the opinion of the investigator, would interfere with the objectives of the study or that may preclude compliance with the study procedures nursing or pregnant (pubescent females require pregnancy testing)

Keywords: xerese acyclovir hydrocortisone cream herpes labialis pediatric
study of pbi-0451 in healthy subjects.

Conditions: Covid19

Summary: this is a phase 1, placebo-controlled, blinded, randomized, dose escalation study of pbi-0451 in healthy subjects. pbi-0451 is a new chemical entity and inhibitor of the main protease of coronaviruses, including the sars-cov-2 that causes covid-19 disease. the study is designed to evaluate the safety, tolerability and pharmacokinetics of pbi-0451 after single and multiple ascending doses and also to explore drug-drug interaction potential of pbi-0451.

combined three part, double blind, (sponsor open) study. part 1: single ascending dose study. part 2: multiple ascending dose study. part 3: drug-drug interaction study.

Eligibility criteria:
inclusion criteria: 1. non-smoking, healthy male or female subjects aged 18-59 years. 2. body mass index (bmi) of ≥ 19.0 and ≤ 30.0 kg/m2. 3. 12-lead electrocardiogram (ecg) evaluation without clinically significant abnormalities. 4. normal renal function, including having a creatinine clearance (clcr) ≥90ml/min 5. male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception. 6. screening laboratory assessments must be without clinically significant abnormalities as assessed by the investigator. exclusion criteria: 1. pregnant and lactating females 2. have received any investigational drug (or vaccine) within the last 30 days prior to study dosing. 3. have a positive test result for hiv or hbsag. 4. have poor venous access that limits phlebotomy 5. have taken any prescription medications or over-the-counter medications, including herbal products and dietary supplements within 28 days prior to start of study. 6. have been treated with systemic steroids, immunosuppressant therapies, or chemotherapeutic agents within 3 months prior to screening or is expected to receive these agents during the study. 7. have a history of lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years. 8. have a history of significant drug sensitivity, cardiac disease, syncope, palpitations, or unexplained dizziness, implanted defibrillator or pacemaker, liver disease, severe peptic ulcer disease, gastroesophageal reflux disease and a medical or surgical treatment that permanently altered gastric absorption. 9. have received inactivated vaccinations within 4 weeks prior to randomization or receive live vaccinations within 4 weeks of screening. 10. received the covid-19 vaccine either within 7 days or have not completed the series of required 2 doses. 11. have a history of excessive alcohol use or other illicit drug use within 6 months of screening.