Kornimate/medical-research-clean huggingface dataset:
gl701 (prestara™) in women with systemic lupus erythematosus receiving treatment with glucocorticoids

Conditions: Systemic Lupus Erythematosus

Summary: open label safety and efficacy follow-up.

this was a randomized, multi-center, open-label, parallel-group, trial of prasterone 200 or 100 mg/day for 12 months in women with lupus receiving glucocorticoid therapy who had completed an earlier 6-month randomized, placebo-controlled study (nct00053560. bone mineral density assessments were performed at baseline and at months 6 and 12.

Eligibility criteria:
inclusion criteria: * patient has completed the full 6 month treatment period with study drug in the previous genelabs' clinical study gl02-01. * concomitant treatment with prednisone (or equivalent) at a dose of ≥ 5mg/day. * patient has read and signed an informed consent form. if the patient is not fluent in english, the informed consent must be signed in her native language. exclusion criteria: * patient has had a serious study drug related adverse reaction at any time during the previous gl02-01 study. * any condition which in the investigator's or sponsor's opinion is sufficient to prevent adequate compliance with the study or likely to confuse follow-up evaluation (e.g., alcoholism, drug addiction, acute withdrawal from chemical dependency, psychiatric disease). medications prohibited at any time during the study * calcitonin * bisphosphonates * fluoride at pharmacologic dose * strontium at pharmacologic dose * estrogenic steroids (except oral contraceptives) * selective estrogen receptor modulator (raloxifene) * parathyroid hormone * any androgens, including prescription or nutritional supplement dhea, other than study drug * additional calcium supplements other than those prescribed as part of this study

Keywords: lupus systemic lupus erythematosus sle bone loss dhea
examining the role of family support in bariatric surgery patients

Conditions: Focus of Study is Patient Responses to an Obesity Management Questionnaire Administered by SGH Life Centre

Summary: this study aims to examine the role of family support on the adhesion to post-op procedures in patients who have undergone bariatric surgery in singapore.


Eligibility criteria:
inclusion criteria: undergone bariatric surgery within sgh life centre and must have completed the intake questionnaire exclusion criteria: -
assessment of severity and outcome of addicted cases.

Conditions: Addiction, Substance

Summary: * addiction to drugs and alcohol is increasingly becoming a worldwide trend that is prevalent in both rich and poor countries . substance abuse shows a significant warming to the health, social and economic build of families, communities and nations. extent of worldwide psychoactive substance use is estimated at 2 billion alcohol users and 185 million drug users . * substance abuse (including alcohol and drugs) is an important risk factor for poor health globally due to their intoxicating effects or their toxic effects on organs and tissues that lead to the development of diseases, injuries and other health conditions * drug abuse is associated with the increased risk of cardiovascular diseases. a study on the need for hospitalization in approximately 4800 drug users found that 223 of these were admitted to hospital due to cardiovascular diseases . * the majority of abused substances or their metabolites are excreted through the kidneys and renal complications of drug abuse are very common .the involvement of the kidney due to drug abuse is either attributed to their elimination through the kidney, or a direct nephrotoxic effect. the damage may be acute and reversible, or chronic and can leads to end stage renal failure . * addiction is responsible for different types of liver diseases including fatty liver, hepatitis and liver failure. . intravenous drug addiction by sharing of contaminated needle is very important risk factor for the development of liver diseases, particularly hepatitis b and hepatitis c. globally, 90% of new hepatitis c infections are attributed to drug injection . in the long run, substance abuse has negative effects on sexual functions and leads to the onset of sexual disorders. . * long term use of alcohol was reported to inhibit of hypothalamic-pituitary-adrenal axis and reduces the release of gonadotropins from the pituitary . morphine administration suppresses lh release and reduces the levels of testosterone, which affects testicular function.


Eligibility criteria:
inclusion criteria: * patients who are addicted for at least one year. exclusion criteria: * patients who are addicted for less than one year. * patients with history of previous renal impairment * patients with history of hepatitis b, c or hiv infection * patients with history of autoimmune disease. * patients with history of heart disease.
phase 3 study to evaluate safety and efficacy of iclaprim versus vancomycin for absssi: revive-1

Conditions: Skin Structures and Soft Tissue Infections

Summary: this is a multicenter, randomized, double-blind study of the efficacy and safety of iclaprim compared to vancomycin for the treatment of skin and skin structure infections.

this is a multicenter, randomized, double-blind study of the efficacy and safety of iclaprim compared to vancomycin. patients will receive either iclaprim or vancomycin for 5 to 14 days. patients will be evaluated daily up to early time point (etp), then every 48 to 72 hours through the end of treatment. patients will also be evaluated at the test of cure (toc) visit (7 to 14 days post-eot), and will have a late follow-up (lfu) visit (28 to 32 days post-first dose).

Eligibility criteria:
inclusion criteria: 1. written informed consent; 2. ≥18 years of age; 3. a bacterial infection of the skin with a lesion size area of at least 75 cm2; 4. a major cutaneous abscess, cellulitis/erysipelas, and/or wound infections; 5. the presence of purulent or seropurulent drainage or at least three signs and symptoms of infection (discharge, erythema, swelling, warmth, or pain). exclusion criteria: 1. severely impaired arterial blood supply such that amputation of the infected anatomical site is likely; 2. infected diabetic foot ulcers; 3. infected decubitus ulcers; 4. necrotizing fasciitis or gangrene; 5. uncomplicated skin or skin structure infection; 6. infections associated with a prosthetic device; 7. suspected or confirmed osteomyelitis; 8. conditions requiring systemic anti-microbial treatment, prophylaxis, or suppression therapy.
effects of proprioceptive stimulation under visual feedback in patient with crps

Conditions: Complex Regional Pain Syndromes

Summary: the aim of this study is to evaluate feasibility of a proprioceptive stimulation under visual feedback treatment protocol (using gloreha® device) compared to usual physiotherapy treatment in sub-acute stroke patient with complex regional pain syndrome.

the aim of this study is to evaluate feasibility of a a proprioceptive stimulation under visual feedback treatment protocol (using gloreha® device) compared to usual physiotherapy treatment in sub-acute stroke patient with complex regional pain syndrome. treatments effect will be evaluated on pain perception, upper extremity functionality and change in pain pressure treshold. usual physiotherapy consist of active or passive mobilization, extensor digiti and carpi functional electric stimulation, occupational therapy and taping.

Eligibility criteria:
inclusion criteria: * age \> 18 years and \< 85 years * diagnosis of stroke \< 6 months prior to study enrollment * diagnosis of complex regional pain syndrome according to budapest criteria exclusion criteria: * neurological or psychiatric pathology * severe cardio-pulmonary, renal, hepatic diseases * pregnancy
mhealth mindfulness with patients with serious illness and their caregivers

Conditions: Caregiver Stress Syndrome; Anxiety

Summary: older adults with serious illness and their caregivers have high rates of anxiety and limited access to effective, non-pharmacological treatments. a recent national academy of medicine report recommended increased emphasis on disseminating and implementing evidence-based psychotherapies in order to have maximal public health impact. through this work, i will identify a sustainable and potentially scalable dyadic intervention and delivery model to manage symptoms of anxiety in older adults with serious illness and their caregivers in primary care.

research: up to 70% of adults with serious illness have symptoms of anxiety. undiagnosed and undertreated anxiety contributes to higher risk of pain, depression, fatigue, dyspnea, and polypharmacy. patients with high symptom burden and anxiety heavily impact family caregivers, which nearly 8 million older adults in the u.s. rely on for assistance. decades of research reveal the negative effects of caregiving on caregivers, (e.g., high levels of stress, depression, and anxiety). furthermore, there is a mutuality of distress in the caregiver/patient dyad - when patients suffer psychologically, the caregiver suffers too. unfortunately, older adults and their caregivers have limited access to mental health resources because of shortages of mental health providers as well as logistical issues including time constraints, transportation, and scheduling. the objective of this study is to evaluate the feasibility, acceptability, and preliminary efficacy of mindfulness coach, an mhealth mindfulness therapy intervention developed by the veterans affairs, to reduce anxiety in older adults with serious illness and their family caregivers. an efficacious and scalable behavioral intervention that mitigates symptoms of patient and caregiver anxiety has the potential to reduce distress and enhance coping in the patient-caregiver dyad without contributing to polypharmacy or burdensome appointments. research is urgently needed to evaluate the feasibility, acceptability, and preliminary efficacy of dyadic mhealth mindfulness therapy in older adults with serious illness and their caregivers.

Eligibility criteria:
inclusion criteria: * adults 60+ * diagnosis of or caregiver for individual with serious illnesses (e.g., esrd, cancer, chf, copd, liver disease) * hads-a \> 8 for patient or caregiver * blessed\<6 * fluent in english * vision and hearing does not interfere with mobile device use * caregivers who must be 21+ * caregiver must identify as primary source of informal care for patient * caregiver blessed \<6 * caregiver is fluent in english * caregiver's vision and hearing does not interfere with mobile device use. exclusion criteria: * experience with mindfulness therapy in last 2 years * not fluent in english * vision or hearing that impairs use of mobile device * cognitive impairment more than 6 on blessed.
virtual therapy as a method supporting treatment of late-life depression

Conditions: Depressive Symptoms; Depression; Anxiety

Summary: this study evaluates the addition of virtual therapy intervention in the treatment of depression in the elderly. half of the participants will receive virtual reality treatment as an addition to physical exercises and psychoeducation, while the other half will receive physical exercises and psychoeducation alone.

depressive disorders are frequent and can either first be manifested at a younger age and recurrent during later life or have an onset beyond 60 years (late-life depression). the multifactorial genesis of depression in old age includes psychosocial, vascular and metabolic factors and requires multimodal and multi-professional therapy including physical activity and psychosocial interventions. however, there is still a percentage of older people who do not show improvement in depressive symptoms. in recent years, various types of virtual reality are gaining in popularity, primarily because of the availability and ease of use. a systematic review from 2018 concluded that vr treatment had moderate to large effects in anxiety and depression, compared to controls and it could be another effective choice available to clinicians and patients. therefore, the aim of this project was to evaluate the effectiveness of virtual therapy in the elderly, in whom the previous multimodal therapeutic program has not brought the expected results.

Eligibility criteria:
inclusion criteria: * gds≥10 or hads-a≥8 or hads-d≥8 exclusion criteria: * cognitive impairment (mmse\<24) or aphasia and a serious loss of sight or hearing that makes it impossible to assess cognitive functions based on mmse; * contraindications for virtual therapy (epilepsy, vertigo, eyesight impairment); * substance abuse; * participation in another therapeutic project or individual psychotherapy; * antidepressant treatment;

Keywords: virtual reality depression anxiety mental health elderly psychotherapy rehabilitation
smartphone intervention for smoking cessation and improving adherence to treatment among hiv patients

Conditions: Smoking; Smoking Cessation; HIV

Summary: the purpose of this study is to learn if a mindfulness-based smoking cessation smartphone app can help people quit smoking and stay on antiretroviral therapies.

the current study aims to test the feasibility of a three-arm randomized clinical trial testing the combined mindfulness training + emocha apps intervention versus the mindfulness training app only with brief advice to improve art adherence and usual care (uc; brief advice to quit and improve art adherence). our primary hypothesis is that the combination of mindfulness training + emocha apps would be superior to the mindfulness training app with brief advice to improve art adherence, and these two interventions would be superior to the uc in terms of the feasibility, acceptability, and potential efficacy (3-month smoking cessation; improvement in adherence to art).

Eligibility criteria:
inclusion criteria: * ≥ 18 years old * diagnosed with hiv * have been prescribed art medication in the prior 6 months * have smoked ≥ 5 cigarettes/day in the past year * be interested in making a quit attempt in the next 30 days * own a smartphone (apple/android)and plan to keep it active for the following 3 months * read/speak english * be able to provide consent * have no plans to move in the next 3 months * not pregnant or planning to be pregnant in the following 3 months exclusion criteria: * adults unable to consent * individuals who are not yet adults (infants, children, teenagers) * pregnant women * prisoners * have contraindication to nrt (past month myocardial infarction, history of serious arrhythmias/or unstable angina pectoris, dermatological disorder) * currently being treated for a psychiatric condition * currently being treated for smoking cessation, alcoholism, or illicit drug use

Keywords: nicotine replacement therapy antiretroviral smartphone
comparative efficacy of duloxetine vs escitalopram in patients with fibromyalgia

Conditions: Fibromyalgia

Summary: duloxetine is fda approved as pharmacological treatment for fibromyalgia. the use of ssris has been endorsed by the 2013 canadian guidelines. the data available for escitalopram as a treatment modality for fibromyalgia is limited, however small trials have demonstrated its efficacy. no head to head comparisons between escitalopram and duloxetine have been undertaken. we aim to conduct a single blind, randomized control trial to assess the comparative efficacy of duloxetine vs escitalopram in drug naive patients with newly diagnosed fibromyalgia.

180 drug naive patients with newly diagnosed fibromyalga according to the modified acr 2016 criteria shall be enrolled by consecutive sampling after taking written informed consent. baseline severity of fibromyalgia shall be assessed via the revised fibromyalgia impact questionnaire (fiq-r). they shall be randomized via cluster randomization into two groups. the first group shall receive duloxetine 30mg, will be increased to 60mg after one week. the second group shall receive escitalopram 10mg to be increased to 20mg after one week. patients shall be followed at 0,2,4,8 and 12 weeks. at each visit, any subjective change in symptoms shall be noted and the fiq-r shall be re administered. at the end of the trial, the overall change in the fiq-r from baseline shall be assessed and the difference between both groups will be analyzed.

Eligibility criteria:
inclusion criteria: * drug naive patients * newly diagnosed with fibromyalgia according to modified acr 2016 criteria exclusion criteria: * concomitant depression/bipolar disorder or any other documented psychiatric illness * autoimmune disorders (sle, ra) * peripheral neuropathic pain due to any cause * uncontrolled hypertension * impaired renal or hepatic functions (on lab assay) * chronic infections (e.g.tuberculosis)

Keywords: fibromyalgia treatment duloxetine escitalopram
comparing the effect of metformin vs. pep2dia as an adjunct to letrozole on ovulation induction and pregnancy outcomes in overweight women with pcos

Conditions: PCOS

Summary: the goal of this clinical trial is to compare the effects of metformin versus pep2dia as adjunct treatments to letrozole on ovulation induction and pregnancy outcomes in overweight women with polycystic ovary syndrome (pcos). the main questions it aims to answer are: does metformin improve ovulation rates more effectively than pep2dia when used alongside letrozole? does pep2dia enhance pregnancy outcomes compared to metformin in this patient population? participants will: receive either metformin or pep2dia in addition to letrozole. undergo regular monitoring for ovulation and pregnancy outcomes. researchers will compare the metformin group to the pep2dia group to see if there is a significant difference in ovulation and pregnancy rates between the two treatments.


Eligibility criteria:
inclusion criteria: 1. anovulatory infertile women with pcos for more than one year associated with overweight and seeking pregnancy. 2. married women of reproductive age who lived with a husband and were sexually active. 3. women with resistant to letrozole. 4. normal value of prolactin hormone. 5. age group; 18-35 years 6. bmi ranging from 25 to 29 kg /m². 7. standard parameters of the husband's semen 8. diagnostic criteria for rotterdam diagnosis of polycystic ovary syndrome: two of the following three criteria are required: * oligoovulation or anovulation * hyperandrogenism: clinical (hirsutism or less commonly male pattern alopecia) or biochemical (raised free androgen index (fai) or free testosterone). * polycystic ovaries on ultrasound (christ et al., 2023). exclusion criteria: 1. hypersensitivity to letrozole, metformin or pep2dia. 2. obese women with bmi ≥29 kg/m² or women with bmi \<25 kg/m². 3. fsh above 11 mg. 4. any other cause of infertility other than anovulation due to overweight as uterine factor, tubal factor, male factor, ovarian pathology or endometriosis. 5. any medical disorder that may affect pregnancy or systemic disease (cardiovascular, renal, hepatic, cns diseases and hypo or hyperthyroidism) 6. missed patient 7. discontinuation of drug due to its side effects

Keywords: pcos metformin pep2dia overweight
relaxation guided imagery for treatment of parkinson's disease

Conditions: Parkinson's Disease

Summary: parkinson's disease patients may have pronounced on-off motor fluctuations. these motor fluctuations are currently treated with medication and surgery, which are limited by their efficacy and side effects. our study aims to determine whether relaxation guided imagery can alleviate the off state of pd patients and therefore can be used as an adjunct to conventional medication.

parkinson's disease patients with pronounced on-off motor fluctuations without dementia will participate in this study aimed to examine a possible beneficial effect of relaxation guided imagery on motor fluctuations. the study will include a baseline period two sessions of relaxation and a follow-up period. the relaxation sessions will be conducted individually. in one session patients will hear relaxing music and in the second they will undergo relaxation guided imagery. after each relaxation session patients will receive a cd with either relaxing music or rgi to listen to at home. they will be asked to fill out a diary at baseline and after each session. before and after each relaxation session patients will be examined according to the unified parkinson's disease rating scale and the examination will be videotaped. all patients will continue to receive the usual care from their medical providers. the main measure is change in updrs and secondary measure is change in daily off time.

Eligibility criteria:
inclusion criteria: * patients with idiopathic parkinson's disease suffering from motor fluctuations * h\&y \>2 exclusion criteria: * dementia * hearing impairment

Keywords: parkinson's disease relaxation visual imagery motor fluctuations treatment
clinical outcomes after letrozole treatment according to the estrogen receptor expression in postmenopausal women

Conditions: Breast Cancer

Summary: the purpose of this study is to assess clinical outcomes after letrozole treatment according to the estrogen receptor expression in postmenopausal women with hormone receptor positive breast cancer.

this study aimed at evaluating following: 1. validity assessment: 1. primary end point: to evaluate 5-year diseae free survival rate after letrozole treatment according to the estrogen receptor expression in postmenopausal women 2. secondary end point: to evaluate overall survival rate(os) and time to distance recurrence(ttdr) after hormonal therapy in postmenopausal women with hormone receptor positive breast cancer 2. safety assessment: to evaluate all adverse events including serious adverse events after letrozole treatment.

Eligibility criteria:
inclusion criteria: 1. patients with estrogen receptor(+) and/or progesterone receptor(+) 2. postmenopausal state was defined the following conditions, at least one of a, b 1. serum fsh ≥ 30 miu/ml and amenorrhea ≥ 1 year for below 55 years, over than 55 years 2. bilateral oophorectomy 3. patients have undergone surgery of the breast cancer within 12 weeks and terminated chemotherapy after surgery within 4 weeks. 4. who(ecog) performance status 0-2 5. adequate haematological function, renal function, hepatic function. 6. no evidence of metastasis. exclusion criteria: 1. metachronous bilateral breast cancer. 2. metastatic breast cancer (stage iv) 3. other hormone therapy and hormonal replacement therapy given within the previous 4 weeks, except for estring, vagifem, estrogen cream. 4. patients with child-pugh grade c, serum creatinine\>2xunl 5. patients with gastrectomy, small bowel resection, malabsorption syndrome and dysphagia.

Keywords: breast cancer, letrozole postmenopause hormone receptor positive breast cancer
pilot study of coil arrays in patients with advanced solid tumor malignancies

Conditions: Neoplams

Summary: this is a single center pilot study testing the use of novel coil arrays with mr liver imaging. in part a of the study, up to 30 healthy volunteers will be scanned, with iterative adjustment of coil array geometry and design to optimize imaging characterstics. in part b of the study, 40 patients with advanced solid tumors and at least one liver metastasis measuring \> 1.5 cm in diameter on standard anatomic scans will undergo mr liver imaging with the newly designed coil array, with the use of gadolinium contrast. patients with liver tumors will have the option of undergoing a second mr liver scan during the course of subsequent systemic therapy.


Eligibility criteria:
inclusion criteria (part b only - patients with advanced solid tumor): * advanced solid tumor malignancy and the presence of at least one liver metastasis measuring \> 1.5 cm in longest diameter in axial dimension on standard anatomic imaging exclusion criteria (part b only): * contra-indication to gadolinium contrast (e.g. chronic renal disease, prior allergic reaction) for patient studies exclusion criteria (part a \[healthy volunteers\] and part b): * contra-indication to mri (e.g. pacemaker, severe claustrophobia, suspected presence of mr-unsafe surgical implants or shrapnel)

Keywords: advanced solid tumor