Kornimate/medical-research-clean huggingface dataset:
directly observed therapy in hiv infected adolescent focus groups

Conditions: HIV Infections

Summary: the purpose of this study is to help researchers use information from hiv infected adolescents to design a directly observed therapy (dot) program that will help adolescents take their anti-hiv medications correctly.

the rate of hiv infection among adolescents is increasing at an alarming rate. adherence to antiretroviral therapy has been a major challenge in achieving and maintaining adequate control of the disease in this population. dot has been shown effective in individuals with tuberculosis (tb), but dot in hiv infected populations has not been thoroughly examined. this study will collect information from hiv infected adolescents in order to establish a dot program that will increase successful adherence to hiv treatment and will benefit the public by preventing development of viral resistance and reducing the risk of transmission. adolescent participants in this study will be assigned to one of three 2-hour focus group sessions, each at a different site. the participants will complete a questionnaire and will give input about designing a dot intervention model that will be accepted by adolescents. the model will then be used in a pilot study to determine the feasibility of implementing dot programs in the community to help hiv infected adolescents.

Eligibility criteria:
inclusion criteria: * hiv infected due to high-risk behavior * regular attendee of local adolescent hiv support group * current use of antiretrovirals or history of antiretroviral therapy * permission of parent or legal guardian if participant is less than the legal age of consent. assent of the minor participant should be obtained where required. exclusion criteria: * perinatal hiv infection * visibly distraught or emotionally unstable * pregnancy or breast-feeding

Keywords: treatment experienced
open label trial of rapastinel (formerly glyx-13) in individuals with obsessive-compulsive disorder

Conditions: Obsessive-Compulsive Disorder (OCD)

Summary: this research study tests whether glyx-13 - an experimental drug that acts on a brain receptor called nmda - can decrease symptoms of ocd within hours. this is not a treatment study. results from this study will allow doctors and researchers to better understand if you and others with ocd may respond to a class of medications that target the nmda brain receptor.


Eligibility criteria:
inclusion criteria for patients with no medication washout: * age 18-55 * physically healthy and not currently pregnant * primary diagnosis of ocd * currently off all psychotropic medications and other drugs * able to provide informed consent exclusion criteria for patients with no medication washout: * psychiatric conditions that make participation unsafe (schizophrenia \[either self or first degree relative e.g. siblings, parents\], history of violence, severe depression, eating disorder, substance abuse in prior year\[including nicotine\], lifetime substance dependence disorder \[except nicotine\]) * female patients who are either pregnant or nursing * enrolled in or planning to enroll in cognitive behavioral therapy. * medical conditions that make participation unsafe (e.g., high blood pressure, head injury) * currently on medications that make participation unsafe * history of allergy, sensitivity, or intolerance to n-methyl-d-aspartate receptor (nmdar) ligands including ketamine, dextromethorphan, memantine, methadone, dextropropoxyphene, or ketobemidone. inclusion criteria for patients with medication washout: * age 18-55 * physically healthy and not currently pregnant * primary diagnosis of ocd * currently on adequate dose of medication for treatment of ocd, but have not achieved at least partial remission and able to handle a medication washout. * able to provide informed consent exclusion criteria for patients with medication washout: * psychiatric conditions that make participation unsafe (schizophrenia \[either self or first degree relative e.g. siblings, parents\], history of violence, severe depression, eating disorder, substance abuse in prior year\[including nicotine\], lifetime substance dependence disorder \[except nicotine\]) * female patients who are either pregnant or nursing * enrolled in or planning to enroll in cognitive-behavioral therapy. * patient judged unlikely to be able to tolerated a medication washout. * medical conditions that make participation unsafe (e.g., high blood pressure, head injury) * currently on medications that make participation unsafe * history of allergy, sensitivity, or intolerance to n-methyl-d-aspartate receptor (nmdar) ligands including ketamine, dextromethorphan, memantine, methadone, dextropropoxyphene, or ketobemidone.

Keywords: ocd
metformin's effect on glucagon-induced glucose production and protein metabolism.

Conditions: Insulin Resistance; Prediabetic State

Summary: this study is being done to understand metformin's mechanisms of action regarding glucose production, protein metabolism, and mitochondrial function.

it is believed that metformin antagonizes the action of glucagon through different pathways. in mice, metformin leads to inhibition of adenylate cyclase, reduction of levels of cyclic amp and protein kinase a (pka) activity, therefore blocking glucagon-dependent glucose output form hepatocytes. glucagon plays an important role in the increased catabolic state seen in insulin deficiency. hyperglucagonaemia states have been shown to accelerate proteolysis and leucine oxidation in insulin-deficient humans. patients with insulin resistance and increased levels of glucagon have an increased in energy expenditure which may contribute to the catabolic state associated with this condition. we hypothesized that treatment with metformin for 2 weeks will significantly inhibit glucagon-induced endogenous glucose production in insulin resistant individuals. we also hypothesized that glucagon-induced alterations in whole body protein metabolism and the increases in o2 consumption associated with hyperglucagonaemia states will be significantly inhibited by metformin in these individuals. this would open the door for the development of other antidiabetic drugs with antagonism of glucagon as their principal mechanism of action.

Eligibility criteria:
inclusion criteria: * 35-65 years of age * fasting blood glucose \>100 mg/dl * bmi 27-36 kg/m2 * waist circumference: men ≥ 104 cm; women ≥ 88 cm * if previously on anti-diabetic medication, should be off for at least 1 month exclusion criteria: * active use of hypoglycemic agents (\< 1 month) * renal failure, creatinine ≥ 1.5 mg/dl in men or ≥ 1.4 mg/dl in women * alanine aminotransferase levels exceed 135 iu/l or aspartate aminotransferase levels exceed 129 iu/l (3 x the upper limit of normal) * congestive heart failure (ef \< 40 %) * active coronary artery disease * recent (less than 6 weeks) or planned imaging study requiring iv contrast * participation in structured exercise (\> 2 hr per week) * recent change in dietary habits or weight * tobacco use * use of systemic glucocorticoids * anti-coagulant therapy (warfarin/heparin) * pregnancy or breastfeeding * alcohol consumption greater than 2 drinks/day * uncontrolled hypothyroidism, abnormal thyroid stimulating hormone levels * metformin allergy

Keywords: insulin resistance prediabetic state metformin
oral t-8 oral testosterone for male hormonal contraception

Conditions: Healthy

Summary: the purpose of this study is to test how the body absorbs a new form of oral testosterone (t). on day 1 and day 9 there are overnight stays in the general clinical research center at the university of washington to monitor blood testosterone levels over a 24-hour period.

we will administer two experimental drugs, acyline and oral testosterone. acyline shots will be given on day 0 to turn off the body's testosterone production for about 10-14 days. the next day, day 1, subjects begin taking 300 mg modified slow-release testosterone pill by mouth, three times a day, around 9 am, 1 pm, and 7 pm for a total of 27 pills. there are overnight stays on day 1 and day 9 to allow monitoring of blood testosterone levels over a 24 hour period, from @9 am to 9 am the next morning. at those visits, blood is drawn at baseline (before taking the pill) and at 1, 2, 4, 5, 6, 8, 10, 11, 12, 14, 16, and 24 hours after the morning dose. acyline is an experimental drug. the fda allows its use only in research with a small number of volunteers. we have used acyline in over 125 men without serious side effects. the use of testosterone in this study is experimental and there may be unknown or unanticipated risks.

Eligibility criteria:
inclusion criteria: * able and willing to * not participate in another drug study or donate blood, not take medications * use contraception, comply with the protocol exclusion criteria: * abnormal evaluation, based on physical exam, medical history, blood tests (including serum chemistry, hematology, hiv, hcv, hormone levels) * history or current use of alcohol, drug, steroid abuse, \>3 alcohol drinks/day * history of testicular disease, severe testicular trauma, major psychiatric disorder, bleeding disorders, current use of anti-coagulants or testosterone * participation in hormonal drug study within past month

Keywords: experimental acyline plus 27 oral testosterone pills taken 3x/day
the stockholm creatinine measurements project

Conditions: Chronic Kidney Diseases; Acute Kidney Injury; Diabetes Mellitus; Cardiovascular Diseases; Hypertension

Summary: the stockholm creatinine measurements (scream) project is a healthcare utilization cohort including, at present, all adult residents in stockholm between 2006 and 2021. the region of stockholm had a population of 2.3 million citizens in 2021and provides universal healthcare with a single unified health-system. administrative databases with complete information on socidemographic data, healthcare use, diagnoses and therapeutic/surgical procedures, and vital status were enriched with performed laboratory tests, dispensed prescriptions at swedish pharmacies and validated kidney replacement therapy endpoints. registries were linked and de-identified by the swedish national board of welfare and are considered to have no or minimal loss to follow-up. because the study utilized de-identified data, it was deemed not to require informed consent and was approved by the regional ethical review boards and the swedish national board of welfare. for detailed description of available data and linked registers please consult: https://pubmed.ncbi.nlm.nih.gov/35028991/

please consult cohort description in: https://pubmed.ncbi.nlm.nih.gov/35028991/ https://pubmed.ncbi.nlm.nih.gov/26798472/

Eligibility criteria:
inclusion criteria: for both cohorts: be a resident of stockholm during 2006-2021, of all ages for the primary cohort: to have undertaken at least one test of serum creatinine or albuminuria during 2006-2021. if this condition is met, we will then extract a broad range of laboratory tests for the secondary cohort: anyone not undertaking a test of serum creatinine or albuminuria will conform the secondary cohort. in this cohort we will not extract any other laboratory test, but will obtain the rest of healthcare information exclusion criteria: none
conexion: a localized information resource on diabetes and depression for a low-income hispanic community

Conditions: Diabetes Mellitus; Depression

Summary: the proposed conexion resource combines best publicly available evidence-based information and local community resources in one place. the information is curated and contextualized to meet local needs of consumers and providers. content is tailored culturally and geographically to fit the community. this approach is consistent with evidence showing that individuals' interactions with health information and technology are "community embedded".

nationwide, hispanics have many barriers to accessing health information, and are subject to significant health disparities, including disproportionate burden of diabetes and untreated mental illness. the research team's preliminary research has identified diabetes and depression as the highest priority needs in the study community of washington heights-inwood (wahi), which is an urban, low-income neighborhood in new york city with 71% hispanic residents, predominantly immigrants from the dominican republic. many high-quality health information resources already exist on the internet but they are not reaching many segments of the population, including parts of the wahi community. the novel concept the investigators propose here is an information resource localized to a community.

Eligibility criteria:
inclusion criteria: * age 18 or older * washington heights/inwood resident (zip codes 10032, 10033, 10034, 10040) * interest in information on diabetes or depression * speak english or spanish exclusion criteria: -

Keywords: conexion diabetes depression low-income hispanic
comparative effectiveness in the management of irreversible pulpitis

Conditions: Irreversible Pulpitis

Summary: this project addresses a central question within the practice of dentistry: is a pulpotomy procedure effective in the treatment of a tooth with symptomatic irreversible pulpitis and normal periapex? in addition, the project seeks to identify clinical and molecular biomarkers that are predictive of the success of pulpotomy.

in this study, patients will be randomized to two groups. all patients will have a diagnosis of irreversible pulpitis with normal apical tissues. the groups will be root canal treatment and pulpotomy. the patients will be followed clinically and radiographically for 2 years following the treatment. predictors of the outcome of pulpotomy will be clinical and laboratory-based parameters.

Eligibility criteria:
inclusion criteria: * maxillary or mandibular first or second mature permanent molars with carious lesions or restorations (excluding crowns), with signs and symptoms of symptomatic irreversible pulpitis (defined as spontaneous pulpal pain and cold hyperalgesia \>30 seconds), and normal apical tissues. * tooth is responsive to cold and electrical pulp testing. * patients aged ≥12 years for first molars and ≥16 years for second molars. exclusion criteria: * evidence of pulp necrosis or apical periodontitis, preoperatively or upon inspection of an exposure site * teeth that are badly broken down and/or are not restorable. * teeth with mechanical allodynia assessed by registering bite force that is at least 50n lower than the contralateral side. * teeth with radiographic evidence of internal, or external cervical, inflammatory or replacement root resorption, or with complete pulp canal obliteration. * radiographic evidence of pdl space wider than three times normal width * clinical evidence of swelling or sinus tract * periodontal pocket probing depth ≥5 mm in any site around the tooth. * clinical evidence of cracks connecting mesial and distal surfaces and/or extending in pulp chamber or associated with periodontal pockets ≥ 5 mm. * history of taking centrally acting drugs (e.g., tricyclic antidepressants), which interfere with the release of pain mediators and/or modify pain experience, within the previous 6 months. * use of medications that affect the host response such as methotrexate, corticosteroids or cyclosporin. * patients on immunosuppressive agents, chronic corticosteroid use, autoimmune disease, or other immunocompromising diseases or medications. * patients who require iv sedation or general anesthesia for their dental treatment. * teeth with full coverage crowns. * teeth undergoing active orthodontic movement. * teeth that require elective rctx to place a post for restorative purposes. * teeth with no contralateral molars with normal pulp and periapical tissues for bite and pulp testing controls. * teeth in the pulpotomy group in which, following complete pulpotomy, bleeding does not stop after 10 minutes with 3-4% hypochlorite cotton pellet. these will be considered treatment failure and treated with rctx.

Keywords: pulpotomy vital pulp therapy
repetitive transcranial magnetic stimulation in drugs addiction

Conditions: Substance Use Disorders

Summary: this study also aims to develop and apply a standard repetitive transcranial magnetic stimulation (rtms) protocol on drug users. the investigators want to focus on the effects of rtms on amphetamine and cocaine as they are the most commonly used types of illicit drugs in hong kong. the primary research question is: • to examine if rtms can reduce craving and consumption of the most commonly used illicit drugs (amphetamine, cocaine) among people with drug use disorders in hong kong? the secondary research questions are: * what is the association between rtms protocol (frequency, intensity) and drug craving and consumption? * would there be gains in executing functioning among participants who have received rtms treatment? * would there be a reduction in depressive and anxiety symptoms among participants who have received rtms treatment? the investigators would use a cross-over design (figure 1) to investigate the effects of rtms. the investigators would recruit participants through community drug rehabilitation and youth outreach services. participants who meet the selection and exclusion criteria will be invited to join. upon obtaining their written consent, the investigators would randomize participants to a treatment (rtms) group and a sham stimulation (placebo) group. upon completing the first phase (2 weeks), there would be a washout period of 2 weeks. the two groups will swap (treatment becomes sham, and vice-versa) and the second phase will proceed. a double-blinded procedure will be implemented. outcome measures will be conducted at baseline, after phase i, at the start of phase ii, and at the end of phase ii.


Eligibility criteria:
inclusion criteria: 1. aged 18 to 60. 2. illicit drug users in the community (not in institutions). 3. uses either amphetamine (ice) and/or cocaine frequently (at least 4 times per week). 4. craving visual analogue scale (vas, 11-point from 0 - 10) score of at least 5 or above on either amphetamine or cocaine. 5. interest in participating in drug treatment or rehabilitation or have already engaged in such services offered by health or social services. 6. not engaged in pharmacological or physical treatment related to substance use disorders in past six months. exclusion criteria: 1. have a history of seizures or a family history of epilepsy. 2. have severe mental disorders like bipolar disorder or psychosis. 3. have brain damage from illness or injury, such as a brain tumor, a stroke or a traumatic brain injury. 4. have any metal or implanted medical devices in the body. 5. have frequent or severe headaches. 6. pregnant or thinking of becoming pregnant. 7. had prior treatment with rtms in the past year.

Keywords: transcranial magnetic stimulation substance use disorders craving
combined use of oxytocin and misoprostol in the prevention of post partum haemorrhage

Conditions: Hemorrhage; Complicating Delivery

Summary: to demonstrate that the combined used of oxytocin and misoprostol prevent from post partum haemorrhage better than oxytocin alone, following vaginal birth at 36 to 42 weeks.

objective : to demonstrate that the combined used of oxytocin and misoprostol prevent from post partum haemorrhage better than oxytocin alone, following vaginal birth at 36 to 42 weeks'. method : double blinded randomized controlled trial in two centers over 30 months. treatment : patients will be randomly allocated into one of the two following group : group a : 10 ui of oxytocin iv during delivery of the anterior shoulder of the newborn and two misoprostol tablets taken orally (400µg) following cord clamp. group b: 10 ui of oxytocin iv during delivery of the anterior shoulder of the newborn and two placebo tablets taken orally following cord clamp. number of patients: 1550 patients per group (one third reduction of occurrence with alpha and beta set at 0.05 and 0.20 respectively). patients were included in the study during 48 hours.

Eligibility criteria:
inclusion criteria: * women\>18 years, * during first stage of normal labor, * at 36 to 42 weeks, * with epidural analgesia and informed signed consent exclusion criteria: * cesarean section delivery, * clotting disorders, * prostaglandin allergy, * absent consent.

Keywords: post partum haemorrhage, oxytocin, misoprostol, prevention, delivery.
a study of zoledronic acid in the prevention of cancer therapy-induced bone loss

Conditions: Primary Hormone Receptor Negative Breast Cancer in Premenopausal Women

Summary: breast cancer and osteoporosis are two of the most frequent diseases in women. estrogen may be associated with bone loss and the risk of breast cancer because of its potent effects on the mitotic activity of breast epithelium and on bone turnover. this study is will assess the safety and efficacy of zoledronic acid 4 mg, given every 3 months over 24 months, in improving bone mineral density in premenopausal women with hormone receptor negative breast cancer and adjuvant chemotherapeutic treatment compared to placebo. this study is not recruiting patients in the united states.


Eligibility criteria:
inclusion criteria: * female patients with histologically confirmed incident invasive breast cancer (t1-4) with no evidence of regional lymph node metastasis (n0) or distant metastasis (m0) and after complete primary tumor resection and axillary lymph node dissection less than 90 days before start of study drug treatment. * hormone receptor status is negative * patient is premenopausal (spontaneous and regular menses with premenopausal estradiol levels (\>10ng/dl) * patient receives adjuvant standard chemotherapy with approved cytotoxic chemotherapeutic drugs (e.g. ac 4-6 cycles) (prior neoadjuvant ct is allowed) * bone density at study entry \> -2.5 t-score exclusion criteria: * prior treatment with bisphosphonates and estrogens or treatments for osteoporosis in addition to calcium and vitamin d * severe physical or psychological concomitant diseases and other known concurrent, severe medical disorder jeopardizing the life of the patient in the immediate future (e.g., myocardial infarction in previous six months, angina pectoris despite treatment, uncontrolled severe arterial hypertension, progressive cardiac or respiratory failure) * known hypersensitivity to bisphosphonates * abnormal renal function * current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (onj), of exposed bone in the mouth, or of slow healing after dental procedures and recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants)

Keywords: breast cancer premenopausal bone mineral density cancer therapy induced bone loss zoledronic acid