Kornimate/medical-research-clean huggingface dataset:
2. study to evaluate the efficacy/safety of bremelanotide in premenopausal women with hypoactive sexual desire disorder

Conditions: Hypoactive Sexual Desire Disorder

Summary: a phase 3, randomized, double-blind, placebo-controlled, parallel-group trial with an optional open-label extension to evaluate the efficacy of bremelanotide (bmt), administered subcutaneously (sc) on an as needed basis for the treatment of hsdd (with or without decreased arousal) in premenopausal females.

this will be a multicenter, randomized, placebo-controlled, parallel group study in up to 80 sites in the united states of america (usa) and canada to evaluate the efficacy and safety of a fixed dose of sc bmt versus placebo on an as-needed basis under conditions of home use in premenopausal women with hsdd (with or without decreased arousal). the study will consist of 2 phases: (1) core study: 4-week no-treatment qualification period, a 4-week single-blind placebo treatment period (baseline), and a 24-week double-blind treatment period where participants will self-administer placebo or bmt 1.75 mg sc via an autoinjector; and (2) extension phase: a 52-week open-label treatment period during which all subjects will receive bmt 1.75 mg. primary objective • to evaluate the efficacy of bremelanotide (bmt), administered subcutaneously (sc) on an as needed basis for the treatment of hsdd (with or without decreased arousal) in premenopausal females. secondary objectives * to evaluate the efficacy of bmt in premenopausal women in the double-blind core study, as assessed by subject responses to questionnaires measuring sexual function, treatment satisfaction, and distress associated with sexual dysfunction. * to evaluate the safety of bmt in premenopausal women in the double-blind core study. * to evaluate the safety of long-term therapy with bmt in the open label extension phase. * to evaluate the efficacy of long-term therapy with bmt in the open-label extension phase.

Eligibility criteria:
main inclusion criteria: * has met diagnostic criteria for hsdd for at least 6 months * is willing and able to understand and comply with all study requirements * has a normal pelvic examination at screening main exclusion criteria: * subjects should be generally healthy premenopausal females with no psychological, gynecological or urological conditions which might contribute to the sexual dysfunction, compromise study participation, or confound interpretation of the study results * not currently under treatment for the sexual dysfunction and willing to forego other treatments through the course of the clinical trial

Keywords: hsdd female sexual desire disorder decreased desire female sexual dysfunction
women's perspective on first-trimester preeclampsia screening

Conditions: Woman's Role; Preeclampsia; Screening

Summary: the aim of this study is to evaluate women's perception on first-trimester preeclampsia screening as it is performed currently in daily practice. thus, the investigators will assess the degree of satisfaction regarding the information received previously to the date of screening, and on the same day the screening is performed (at the time of first-trimester scan). women's unsderstanding regarding preeclampsia screening will be evaluated by means of an anonymous online questionnaire. anxiety and stress related to the results will also be assessed.

preeclampsia screening was established in catalonia in 2018. however, little training for professionals (doctors and midwifes) was performed. women's opinion regarding screening was not asked prior to its implementation, and most women no dot receive any information prior to be screened. women's opinion on their pregnancy follow-ups is important, but this aspect is often not included in clinical practice policies. thus, the objective of the study is to evaluate women's perception regarding current clinical practice in screening of preeclampsia, and their degree of satisfaction. screening and risk-assessments during pregnancy are also a potential cause of stress for women. anxiety and stress regarding preeclampsia screening results will also be evaluated.

Eligibility criteria:
inclusion criteria: * older that 18 years old * singleton pregnancy * low risc of cromosomal abnormalities (\<1/1100) * normal first trimester ultrasound (no evidence of fetal malformations) exclusion criteria: - pacients will diagnosed mental disorders (including depression and anxiaety disorder)

Keywords: preeclampsia screening first-trimester women's perception anxiety stress clinical practice
stability of revision total hip arthroplasty implants using radiostereometric analysis

Conditions: Osteoarthritis of Hip; Failure of Primary THA

Summary: the specific aim is to quantify the stability of the acetabular and femoral components of a revision total hip arthroplasty (tha) in vivo as currently performed at our institution. in this way, the investigators will gain insight into the outcome of the current state of the art of revision arthroplasty surgery. in the past, acetabular and femoral component stability has been measured using radiostereometric analysis (rsa) and when patients having revision total hip operations were compared to patients undergoing primary total hip operations it was possible to determine differences in stability and this was predictive of the intermediate to long-term performance of the acetabular and femoral reconstruction. the investigators propose to use this established, high resolution technique to assess and compare the stability of the revision implants.


Eligibility criteria:
inclusion criteria: 1. male or female. 2. 25 to 75 years of age. 3. subjects requiring revision total hip replacement. 4. subjects who demonstrate the ability to return to mgh for follow-up for the next five years. exclusion criteria: 1. subjects with limited life span. 2. subjects with difficulty in comprehending study protocol for any reason. 3. subjects with complex disease entities which significantly increase the risks of the surgery such as any major platelet abnormality, hematological disorder, or any other major medical complication which could substantially reduce longevity, put them at further risk due to immunocompromisation or increase the risk of infection. 4. female subjects that are pregnant or who may suspect they are pregnant or who plan to become pregnant while participating in this study. * a urine hcg will be done in all women of child bearing potential prior to rsa imaging at each follow-up visit. the result will be recorded in the research record.

Keywords: clinical outcomes radiographic outcomes total hip arthroplasty survivorship
trial to evaluate efficacy and safety of lenabasum in dermatomyositis

Conditions: Dermatomyositis

Summary: this is a phase 3 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of dermatomyositis. approximately 150 subjects will be enrolled in this study at about 60 sites in north america, europe, and asia. the planned duration of double-blind treatment with study drug is up to 52 weeks.

subjects will be randomized to receive lenabasum 20 mg twice per day, lenabasum 5 mg twice per day, or placebo twice per day in a 2:1:2 ratio. the primary efficacy outcome at week 28 will compare lenabasum 20 mg bid to placebo the total improvement score (tis), which is a weighted composite measure of improvement from baseline in six endpoints: physician global assessment of disease activity, physician assessment of extramuscular disease activity, patient global assessment of disease activity, health assessment questionnaire (patient-reported disability), manual muscle testing (mmt), and muscle enzymes.

Eligibility criteria:
inclusion criteria: * fulfill at least one of the following criteria for dermatomyositis: 1. bohan and peter criteria (bohan and peter, 1975a; bohan and peter 1975b) 2. acr/eular criteria (lundberg et al, 2017) * disease activity/severity fulfills at least one of the following three criteria: 1. mdga ≥ 3 cm (0 - 10 cm visual analog scale \[vas\]) and mmt-8 score ≤ 142 (out of 150 total possible) 2. sum of mdga, ptga and emga vas scores is ≥ 10 cm (0-10 cm vas for each) 3. mdga ≥ 3 cm (0-10 cm vas) and cdasi activity score of \> 14 * stable doses of immunosuppressive medications for dm as defined by: 1. unchanged dose of oral corticosteroids ≤ 20 mg per day prednisone or equivalent for ≥ 4 weeks before visit 1 2. unchanged dose of immunosuppressive medications other than oral corticosteroids for ≥ 8 weeks before screening exclusion criteria: * unstable dm or dm with end-stage organ involvement at screening or visit 1 * significant diseases or conditions other than dm that may influence response to the study drug or safety * any of the following values for laboratory tests at screening: 1. a positive pregnancy test (or at visit 1) 2. hemoglobin \< 9 g/dl in males and \< 8 g/dl in females 3. neutrophils \< 1.0 × 10\^9/l 4. platelets \< 75 × 10\^9/l 5. creatinine clearance \< 50 ml/min on screening blood test, per the modification of diet in renal disease study or in 24 hour urine creatine clearance measurement

Keywords: dermatomyositis cannabinoid receptor type 2 agonist jbt-101 lenabasum
evaluation of diabetes and wellbeing programme

Conditions: Type 2 Diabetes; Type 2 Diabetes Treated With Insulin

Summary: this study evaluates the impact of 'dwell' - a 12-week psycho-social education programme designed to help people with type 2 diabetes to better self-manage their condition. up to 600 patients will participate in the programme, while a non-intervention group will receive routine care for their diabetes

the dwell (diabetes and wellbeing) 12-week programme has been designed to incorporate specific elements of diabetes education and is underpinned by motivational interviewing to ensure it is tailored to individuals. each of the four elements of the programme - education, nutrition, physical activity and wellbeing - have been carefully selected based on previous research into diabetes education. the canterbury christ church university (cccu) dwell team are responsible for the evaluation of dwell, which will explore whether the combination of the programme elements is effective in improving self-management. additionally, a process evaluation and cost effectiveness analysis will be conducted alongside participant outcomes the programme will be delivered at five sites (two in the uk, one in belgium, one in france, one in the netherlands). the cccu dwell research team will be responsible for quality assurance, management and analysis of data, sample size assessment and reporting of adverse events. each delivery site is responsible for adhering to their own standard operating procedures.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of type 2 diabetes * over the age of 18 exclusion criteria: * under the age of 18 * pregnant women * individuals who do not have the mental capacity to participate
restart ticrh ap pilot trial

Conditions: Traumatic Intracranial Hemorrhage

Summary: a prospective randomized open-label blinded endpoint (probe) pilot trial of restarting antiplatelet therapy at 1 week versus 3 weeks after traumatic intracranial hemorrhage with a primary composite endpoint of major bleeding and vascular occlusive events.


Eligibility criteria:
inclusion criteria: 1. acute traumatic intracranial hemorrhage on either mono or dual antiplatelet therapy 2. history of stroke, vascular stent or coronary or peripheral arterial disease as indication for antiplatelet \*restarting dual platelet therapy requires one of the following indications: 1) acute myocardial infarction in the last year; 2) coronary stent in the last year; 3) non-cardioembolic stroke in the last 21 days (with switch to monotherapy at 21 days post stroke) 4) peripheral arterial stent in the past month (with switch to monotherapy at one month post stent placement). exclusion criteria: 1. sdh \>8 mm maximum width or any midline shift at any time point or more than one sdh 2. physician plan to start/restart anticoagulant therapy during trial period 3. abbreviated injury scale other than head \>3 4. pregnancy 5. inability to understand need for adherence to study protocol 6. any active pathological bleeding (no acute blood on most recent ct) 7. hypersensitivity to drug or other label contraindication 8. any bleeding that the investigator deems unsafe to restart at 1 week post injury 9. inability to swallow

Keywords: restart antiplatelet traumatic intracranial hemorrhage
the effect of one session osteopathic manuel treatment on femoral artery diameter and flow

Conditions: Peripheral Arterial Disease

Summary: the aim of this study was to investigate the effect of one session omt on arterial circulation in patients with pad.

15 patients with pad were included in the study. the omt circulation model was applied to the participants for one session. before and after the application, femoral artery diameter and flow rate in the patients were evaluated by doppler ultrasound

Eligibility criteria:
inclusion criteria: * patients with at least 3 months of clinical onset of peripheral vascular disease * patients with abi between 0.4-1.4 * patients up to stage 2b according to the fontaine classification system exclusion criteria: * patients undergoing vascular or endovascular surgery in the last 3 months * patients with unstable angina * patients with myocardial infarction (mi) * patients with stroke * patients with heart failure * patients with significant liver or renal failure (ie, dialysis) * acute infectious diseases * patients with neoplasia

Keywords: peripheral arterial disease osteopathic manual treatment
knee pain after intramedullary nailing in the tibia

Conditions: Tibia Fracture; Knee Pain Chronic

Summary: the primary objective of this study is to evaluate the long-term outcome after inserting an intramedullary nail in patients with a tibial shaft fracture using an injury-specific questionnaire.

introduction the treatment of choice for unstable diaphyseal fractures in the tibia is reamed insertion of an intramedullary nail (imn) with the additional placement of interlocking screws. the most common complication after insertion of an imn as treatment of tibial shaft fractures is chronic knee pain with reported rates between 10 % and 87 % with a mean of 47,4 % in metaanalyses. methods the primary objective of this study is to evaluate the long-term outcome after inserting an imn in patients with a tibial shaft fracture using an injury-specific questionnaire. this study includes patients operated on five danish hospitals. a database search was made using operational codes for insertion of an imn in a five-year period. patients aged 18 years or older, alive and residing in denmark at the time of follow-up could be included in the study. these patients then received a knee injury and osteoarthritis score (koos) questionnaire by mail with questions regarding knee-specific symptoms, stiffness, pain, function and quality of life. questionnaires were filled out and returned to the corresponding physician for further analyze. patients who were unable to fill out the questionnaire due to concomitant physical condition or who had undergone amputation or further surgery on the affected limb were excluded.

Eligibility criteria:
inclusion criteria: * patients aged 18 years or older, alive and residing in denmark at the time of follow-up could be included in the study. exclusion criteria: * patients who were unable to fill out the questionnaire due to concomitant physical condition or who had undergone amputation or further surgery on the affected limb were excluded.

Keywords: knee pain intramedullary tibial nail koos
wearability of and myopia progression with zeiss myocare spectacle lenses

Conditions: Myopia

Summary: this is a clinical trial evaluating the wearability and effectiveness of three types of zeiss spectacle lenses in controlling myopia progression. this study compares zeiss myocare spectacle lenses with two types of single-vision spectacle lenses over a 6-month period. this trial aims to evaluate how well these lenses are worn and their impact on myopia progression, including changes in axial length and refractive error. participants will be randomly assigned to wear one of three types of zeiss spectacle lenses. the study will require five visits to the eye clinic over a 6-month period and two virtual follow-up visits.


Eligibility criteria:
inclusion criteria: * be accompanied by a parent or guardian who is able to read and comprehend vietnamese/english and sign a record of informed consent/assent; * at baseline, be within the age range of 7 to 13 years old inclusive; * be diagnosed as myopic having cycloplegic spherical equivalent between -0.75 dioptre (d) and -5.00 dioptre (d); * astigmatism ≤1.50d; * anisometropia of not more than 1.50d; * be willing to comply with the wearing of clinical trial spectacles and clinical trial visit schedule as directed by the investigator; * have ocular findings deemed to be normal; * vision correctable to at least 0.8 or better in each eye with spectacles. exclusion criteria: * any pre-existing systemic or ocular condition, including infection or disease that is likely to affect visual acuity and refractive error; * any systemic disease that adversely affects ocular health e.g. diabetes, graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis, sjögrens syndrome and systemic lupus erythematosus. * use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participant's ocular health / physiology in an adverse or beneficial manner at enrolment and/or during the clinical trial. nb: systemic antihistamines are allowed on an "as needed basis", provided they are not used prophylactically during the trial and at least 24 hours before the clinical trial product is used. * history of eye trauma or eye surgery * amblyopia * anisometropia of not more than 1.50d * strabismus * history of use of myopia control interventions such as orthokeratology or atropine 3 months prior to commencement of this trial. * known allergy or intolerance to ingredients to cycloplegic eye-drops. * currently enrolled in another clinical trial.

Keywords: myopia
droperidol versus metoclopramide + diphenhydramine for the treatment of primary headaches

Conditions: Primary Headaches (Includes Migraines, Tension, Cluster Headaches)

Summary: the purpose of this study is to determine if droperidol is equally as effective as metoclopramide for treatment of primary headaches in the emergency department.


Eligibility criteria:
inclusion criteria: * 18 years old to 65 years old, diagnosis of primary headache exclusion criteria: * allergy to study medications, pregnant, breast-feeding, prisoners, non-english speaking, not eligible to receive droperidol based on ed protocol (see below), patients in whom head trauma, infection, vascular disorders, and disorders of facial or cranial structures are suspected ed droperidol protocol droperidol must not be used in patients with any of the following: * known or suspected qt prolongation, including congenital long qt syndrome * cardiac disease \[cardiomyopathy, congestive heart failure, hypertension, ischemic heart disease, myocardial infarction, bradycardia (\< 50 bpm)\] * history of the following: * renal failure * cerebrovascular disease * diabetes or hypoglycemia * alcoholism/alcohol abuse * pituitary insufficiency * hypothyroidism * hypothermia * anorexia * advanced age (\>65 yrs) * use of the following medications: digoxin, benzodiazepine, diuretics, iv opiates, or other medications known to prolong the qtc interval.

Keywords: headaches migraines tension headaches cluster headaches
developing and evaluating culturally relevant interventions to improve breast cancer screening

Conditions: Breast Cancer

Summary: the goal of this study is to evaluate the relative benefits of an intervention to promote breast cancer screening among women in the white mountain apache (wma) community. women will be randomized to receive care, a culturally tailored mammography education module, or care+coach, which is the care education module plus access to an apache paraprofessional women's health coach (i.e., patient navigator). the care intervention was developed through a community-based participatory research process. the primary outcome is mammography uptake within 2 months of a referral.


Eligibility criteria:
inclusion criteria: * referral for screening mammography from a whiteriver indian health service provider * self-identify as american indian or alaska native (aian) * female * live on within 60 miles of the fort apache indian reservation exclusion criteria: * women who have received a mammogram within the prior 12 months * women with a personal history of breast cancer * unable to participate in full intervention or evaluation due to an anticipated event (e.g., planned move) * unwilling to be randomized

Keywords: mammography cancer screening
changes in muscle tissue in patients with pancreatic cancer

Conditions: Pancreatic Cancer

Summary: rationale: measuring changes in muscle tissue in patients with cancer may help doctors predict how well patients will respond to treatment, and may help the study of cancer in the future. purpose: this pilot study is evaluating changes in muscle tissue in patients with pancreatic cancer.

objectives: * demonstrate a decrease/increase of fat-free mass (ffm) by 10% from baseline, based on tumor progression/regression, within each patient with inoperable locally advanced or metastatic pancreatic carcinoma. * determine the correlation between changes in ffm and 6-month survival. * confirm the frequency of lymphocytopenia in patients with inoperable locally advanced or metastatic pancreatic carcinoma. * demonstrate an interaction between pretreatment total lymphocyte count, treatment response, and 6-month survival in patients with inoperable locally advanced or metastatic pancreatic carcinoma. * collect adjuvant information, such as weight, body mass index, age, ecog performance status, gait speed, concomitant medications, ca19-9, and total lymphocyte count, in these patients. outline: this is a pilot study. patients will have weight, body mass index, age, ecog performance status, gait speed, concomitant medications, ca19-9, and total lymphocyte count measured before start of cancer treatment of the patient's choosing. patients will be re-assessed at approximately 2 months, 4 months, 6 months, and with any change in tumor burden. projected accrual: a total of 17 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * biopsy-proven inoperable locally advanced or metastatic pancreatic adenocarcinoma patient characteristics: * ecog performance status 0-3 * must be able to stand unassisted on a scale * must not have pacemaker or implanted defibrillator prior concurrent therapy: * prior chemotherapy or radiotherapy allowed * no concurrent use of any of the following: * corticosteroids * steroids as anti-emetics associated with chemotherapy allowed * anabolic steroids * thalidomide * megesterol * eicosapentaenoic acid (epa) * nutritional supplements without epa allowed * juven * concurrent enrollment in other clinical trials allowed

Keywords: recurrent pancreatic cancer stage iii pancreatic cancer adenocarcinoma of the pancreas stage iv pancreatic cancer