Kornimate/medical-research-clean huggingface dataset:
development of a methamphetamine early intervention

Conditions: HIV; Sexual Behavior; Methamphetamine; Behavioral Research

Summary: methamphetamine abuse has a strong and consistent epidemiologic association with high-risk sexual behavior and both prevalent and incident hiv in men who have sex with men (msm), and some authorities have advocated methamphetamine treatment as an hiv prevention strategy. however, methamphetamine interventions have not been evaluated in controlled trials, nor have they been implemented and assessed outside of substance abuse treatment programs. this application proposes preliminary investigations to adapt a methamphetamine treatment intervention previously associated with decreased sexual-risk taking among msm for use as an early intervention among msm in seattle, washington. sixty methamphetamine-using msm will be enrolled in a randomized controlled trial of contingency management (cm) versus no intervention. cm participants will have their urine tested for methamphetamine 3 times weekly for 12 weeks, and will receive vouchers of escalating value when their urines test negative; vouchers will be withheld when participants' urines test positive for methamphetamine or participants miss urine testing visits. all participants will undergo urine methamphetamine testing and audio-computer assisted self-interviews on sexual behavior and substance use at baseline and at 6 week intervals for 6 months. participants will be tested for hiv, syphilis, rectal gonorrhea and chlamydial infection, and pharyngeal gonorrhea at baseline and at 3 and 6 month follow-up. the study will determine how often msm will initiate and complete the early intervention, and will longitudinally measure unsafe sexual behaviors among intervention and control participants. study results will determine the feasibility of instituting and studying cm as an early intervention; define whether the intervention is sufficiently promising to justify a larger, definitive randomized controlled trial; and will provide estimates for defining the number of participants such a trial would require.


Eligibility criteria:
inclusion criteria: * anal sex with another man in the month prior to enrollment * use of methamphetamine on at least 2 days in the month prior to enrollment exclusion criteria: * plans to move from the study catchment area within 6 months of enrollment * a mutually monogamous relationships with a man of the same hiv status lasting 2 or more years
the effect of core stabilization exercise program in obese subjects awaiting bariatric surgery

Conditions: Obese; Exercise; Bariatric Surgery Candidate

Summary: in this study, our primary aim is to investigate the effects of structured core stabilization exercise program on functional capacity, body composition, muscle strength, endurance, balance, quality of life in adult obese individuals expecting bariatric surgery. our secondary aim is to provide the individual with exercise habits and increase the level of physical activity in daily life with the exercise program planned according to the needs of the individual.


Eligibility criteria:
inclusion criteria: * individuals aged between 18-65 * bmi ≥30 kg/m2, individuals waiting bariatric surgery * no surgical operation in the last 6 months exclusion criteria: * musculoskeletal disorders or systemic diseases that may prevent exercise * the presence of psychiatric or neurological disease affecting cooperation and cognitive functions * presence of acute pain * heart pain * presence of previous myocardial infarction, subjective heart failure, uncontrolled diabetes and hypertension * regular exercise for 6 months

Keywords: obese core stabilization bariatric surgery exercise
postoperative pain control by use of many drugs in small doses intrathecally

Conditions: Post Operative Pain

Summary: cesarean section is one of the painful operations that require adequate postoperative analgesia. patients are divided into two groups: multimodal (dmm) group ( 30 patients): patients will receive spinal anesthesia with 10-12.5 mg bupivacaine and 1 ml containing 2 mg dexamethasone, 50 µg morphine, and 500 µg midazolam. morphine (m) group (30 patients): patients will receive spinal anesthesia with 10-12.5 mg bupivacaine and 1 ml containing 200 µg morphine


Eligibility criteria:
inclusion criteria: * asa i-ii * age 20-40 years. * pregnant women with living fetus. * body mass index 20- 35 kg/m2. exclusion criteria: * patient refusal. * age \ 40 years * body mass index \ 35. * contraindication to spinal anesthesia (severe mitral or aortic stenosis, coagulopathy, systemic or local infection, increased intracranial pressure and hypovolemia). * placental abnormalities: placental abruption, placenta previa or accrete. * allergy to drugs used in the study.

Keywords: intrathecal morphine, midazolam, dexamethasone, cesarean section
perfusion ct imaging in lung cancer with sbrt

Conditions: Lung Cancer

Summary: the goal of this study is to determine specific perfusion patterns for radiation induced lung changes and residual/recurrent lung malignancies in patients treated with stereotactic body radiotherapy sbrt and thus improve to distinguish radiation changes from residual/recurrent lung cancers. currently ct is often unable to make a clear differentiation between benign and malignant changes in the lung after sbrt treatment necessitating additional wait time to perform follow up cts or biopsies. optimal treatment may be delayed. the investigators want to apply a ct perfusion sequence in addition to the routine follow up cts with the goal to obtain perfusion values of post treatment lung changes and lung tumours. the investigators' hypothesis is that ct perfusion values will help differentiate benign post radiation changes from residual/recurrent tumour in the lung with higher confidence and may help avoid unnecessary delays in cancer treatment.


Eligibility criteria:
inclusion criteria: * gender: male or female * ct ordered for baseline and follow up in patients with lung cancer and lung metastases treated with * patient will sign a consent form prior to study entry * lung cancer and lung metastases are biopsy proven exclusion criteria: * patients who are unable to give valid informed consent * patients who are unwilling or unable to undergo a ct exam, including subjects with contra-indications to ct exams or intravenous contrast material administration.
trial to investigate the effect of dapagliflozin on ischemia reperfusion induced endothelial dysfunction

Conditions: Reperfusion Injury; Vascular Complications

Summary: the aim of the study is to investigate the effect of dapagliflozin or placebo on acetylcholine (ach)- or nitroglycerin (gtn)-induced vasodilation of the forearm resistance vasculature, as determined by fbf measurement before and 10 minutes after 20 minutes of forearm ischemia.

the aim is to test the effect of dapagliflozin or placebo on ach-induced vasodilatation of the forearm resistance vasculature as assessed by fbf measurement before and 10 min after a 20 min forearm ischemia as well as after a 14 day treatment period. the area under the dose-effect curve (auc) of different ach doses will be calculated and compared between treatment groups (dapagliflozin vs. placebo) and different time points (pre-ischemia vs. post-ischemia). fbf measurements will be made in response to increasing intra-arterial doses of ach (25, 50, 100 nmol/min) to assess endothelial function or gtn (4, 8, 16 nmol/min) to test vascular smooth muscle vasodilator function.

Eligibility criteria:
inclusion criteria: * healthy male subjects; 18 - 40 years of age * body mass index between 18 and 27 kg/m2 * written informed consent * normal findings in medical history * non-smoking exclusion criteria: * regular intake of any medication including otc drugs and herbals within 2 weeks before imp administration * history of occlusive vascular diseases * history of vascular anomalies * history of coagulation disorders * history of diabetes mellitus (type 1\&2) or pre-diabetes (i.e. hba1c ≥ 5,7 %) * history of kidney disease * history of ketoacidosis * impaired liver function (ast, alt, ggt, bilirubin \>3 x uln) * impaired renal function (serum creatinine \> 1.3 mg/dl) * any other relevant deviation from the normal range in clinical chemistry, haematology or urine analysis * hiv-1/2-ab, hbsag or hcv-ab positive serology * systolic blood pressure above 145 mmhg, diastolic blood pressure above 95 mmhg * known allergy against any test agent under study and/or lactose intolerance * regular daily consumption of more than on litre of xanthine-containing beverages or more than 40g alcohol * participation in another clinical trial during the preceding 3 weeks

Keywords: dapagliflozin forearm blood flow measurement reperfusion injury vascular function
comparison study of using ultrasound guidance for hematoma blocks vs. traditional approach

Conditions: Forearm Fracture

Summary: will use visual analog scales to compare effectiveness of traditional hematoma block vs ultrasound guided hematoma block with regards to pain. this will be done for closed forearm fractures.


Eligibility criteria:
inclusion criteria: * age \> 18 * closed forearm fracture exclusion criteria: * mentally impaired, visually impaired or deaf * age \< 18 * alcohol on board
inspiratory muscle training efficiency before bronchoscopic procedure

Conditions: Copd; IMT

Summary: the aim of this study is to examine the effectiveness of inspiratory muscle training (imt) before bronchoscopic procedure in chronic obstructive pulmonary patients (copd). patients with a diagnosis of copd, who are listed for a bronchoscopic procedure and referred to the pulmonary rehabilitation (pr) clinic, will be randomly divided into two groups. standard pr exercise program will be applied to both groups. in addition to the standard program, imt will be applied to one of the groups. the effect of imt on exercise program gains will be examined.

* cases diagnosed with copd by a chest diseases specialist at yedikule chest diseases and thoracic surgery training and research hospital will be included in the study. * the cases meeting the inclusion criteria will be randomized and divided into two groups, called the standard rehabilitation group (prgr) and the inspiratory muscle training group (imtgr). * initial exercise sessions and all evaluations of all cases will be performed in the hospital. the 2nd and 3rd training repetitions will be held at their homes via online synchronized videoconferencing. the exercise video will be sent to the smart phones of the cases who have completed 3 training sessions. participants will be called once a week by phone and exercise follow-up will be carried out. * all subjects will continue to exercise 5 days a week for 2 months. the standard pr consists of breathing exercises, peripheral muscle strength and self walking training. in addition, imt was applied to imtgr.

Eligibility criteria:
inclusion criteria: * being between the ages of 18-75 * having a diagnosis of copd diagnosed according to clinical diagnostic criteria according to -american thoracic and european respiratory societies (ats-ers) and being a candidate patient for bronchoscopic lung volume reduction procedure * presence of dyspnea on exertion * stable clinical state at the time of inclusion without infection or exacerbation in the previous 4 weeks * ability to use a smart phone exclusion criteria: * patients with severe comorbid diseases, unstable coronary artery disease, collagen vascular diseases and needing high flow oxygen therapy (˃ 3-4 l \\min). * a history of effort-related syncope or any comorbidity (such as severe orthopedic or neurological deficits or unstable heart disease) that precludes exercise training. * participation in a pulmonary rehabilitation program within the past 12 months.

Keywords: imt copd pulmonary rehabilitation bronchoscopic procedure bronchoscopic lung volume reduction valve coil balloon
the effect of endovascular thrombectomy on autonomic nervous system in patients with large-vessel ischemic stroke

Conditions: Autonomic Nervous System

Summary: the autonomic nervous system (ans), regulating involuntary physiologic processes including heart rate and blood pressure, is affected by changes in the cerebral vessels like carotid artery stenosis, occlusion, carotid artery stent and endarterectomy. until now, no data concerning autonomic nervous system in patients with acute intracranial large artery occlusion and thrombectomy is available. due to the known effect on ans in case of pathologies of extracranial brain supplying arteries it is highly suspected that intracranial large artery occlusion and thrombectomy can affect the ans as well. the aim of this project is to determine autonomic parameters during and after thrombectomy in patients with large cerebral artery occlusion. the project is a prospective descriptive pilot study at the university hospital tulln. 20 patients will be assessed during and after thrombectomy up to three months post intervention. a combination of autonomic parameters, hemodynamic parameters and clinical outcome will be evaluated.


Eligibility criteria:
inclusion criteria: * age: \> 18 years of age * acute ischemic stroke with large extra- and intracranial artery occlusion and intraarterial mechanical thrombectomy treatment. * successful recanalization after thrombectomy with tici 2b or 3. * informed consent by the patient exclusion criteria: * informed consent not possible within 7 days after thrombectomy due to impaired awareness or speech disturbances. * permanent stent during thrombectomy. * severe complications, such as severe intracranial hemorrhage, during or after thrombectomy including prolonged icu stay. * modified rankin scale (mrs) over 3 before admission. * diagnosis of dementia with mini mental state examination (mmse) \< 26 points in the medical history * intracranial hypertension in the medical history or brain imaging. * patent foramen ovale in the medical history. * glaucoma in medical history. * inability to complete study visits

Keywords: stroke thrombectomy autonomic nervous system
mt2018-18: sleeping beauty transposon-engineered plasmablasts for hurler syndrome post allo hsct

Conditions: Mucopolysaccharidosis Type IH (MPS IH, Hurler Syndrome); Mucopolysaccharidosis Type IH; MPS IH, Hurler Syndrome

Summary: this is a single center, phase 1/2 study in which patients with hurler syndrome who have previously undergone allogeneic hematopoietic stem cell transplantation are treated with autologous plasmablasts engineered to express α-l-iduronidase (idua) using the sleeping beauty transposon system.


Eligibility criteria:
inclusion criteria: * diagnosis of mucopolysaccharidosis type ih (mps ih, hurler syndrome) * underwent a previous hematopoietic stem cell transplant \>1 year prior to study enrollment * age ≥3 years and ≤8 years at time of study registration * ≥ 10 kilograms body weight * creatinine \<1.5 normal for gender and age. * ejection fraction ≥ 40% by echocardiogram * must commit to traveling to the university of minnesota for the necessary followup evaluations * must agree to stay in the twin cities area (\<45-minute drive from the masonic children's hospital) for a minimum of 5 days after each cell infusion * voluntary written parental consent prior to the performance of any study related procedures exclusion criteria: * prior enzyme replacement therapy within 4 months prior to enrolling on study * history of b cell related cancer, ebv lymphoproliferative disease or autoimmune disorders * evidence of active graft vs. host disease * requirement for systemic immune suppression * requirement for continuous supplemental oxygen * any medical condition likely to interfere with assessment of safety or efficacy of the study treatment. * in the investigator's judgement, the subject is unlikely to complete all protocol required study visits or procedures, including follow up visits, or comply with the study requirements for participation.

Keywords: mps ih hurler syndrome
the impact of melanoma and drug treatment in the real world

Conditions: Melanoma

Summary: an observational, non-interventional registry study to collect real-world data from people living with melanoma and its treatment, which will be available to researchers to further the knowledge of melanoma and improve patient care.

the registry uses vitaccess' digital real-world evidence platform, and has been developed in collaboration with the patient advocacy group melanoma uk. eligible participants install a study app on their smartphone or tablet. researchers access aggregated, anonymised data via a cloud-based research portal. the platform provides benefits to participants, which it is hoped will encourage persistence with data submission; these include options to upload electronic documents such as scans, and access an online melanoma community. the aggregated data are available in close to real time via "dashboards" and can be analysed according to a number of pre-set criteria (e.g. disease stage, age, geographic location). state-of-the-art technologies and security policies are used in the platform to ensure industry-standard data storage and privacy for all users. participants' personally identifiable information will remain confidential at all times, and researchers will not be able to identify individuals.

Eligibility criteria:
inclusion criteria: * adults with melanoma of any stage, resident in the uk with national health service (nhs) or community health index (chi) number, aged 18 and over, current or previous diagnosis of melanoma, willing to use their own smartphone or tablet. exclusion criteria: * no specific exclusion criteria
complex and simple appendicitis: restrictive or liberal post-operative antibiotic exposure - ucsf

Conditions: Appendicitis

Summary: the purpose of this study is to demonstrate the safety, efficacy, and feasibility of short-course post-operative antibiotic treatment for simple and complicated appendicitis

this is a single center, randomized controlled trial to determine if decreasing the amount of antibiotics after appendicitis surgery can decrease the risk of adverse effects associated with antibiotics while at the same time ensuring participant safety.

Eligibility criteria:
inclusion criteria: age ≥ 18 years * age ≥ 18 years * planned appendectomy (laparoscopic or open) * working telephone number or reliable method to contact patient after hospital discharge exclusion criteria: * unable to consent * pregnant women * prisoners * immunocompromised as determined by clinical team, or patients actively receiving steroids, chemotherapy, or immunosuppressing medications (for example tacrolimus), or patients with active hematologic malignancy affecting the immune system, leukopenia, or end-stage aids * heart failure * allergy to bupivacaine * unlikely to comply with treatment or follow-up * inpatient consultation for appendicitis * clinically suspected of sepsis based on sepsis-3 definition * current use of antibiotics for other indications * type 1 diabetes or uncontrolled hyperglycemia * surgeon preference * patient preference * research team unavailable
study to assess the long-term safety of dupilumab administered in participants ≥6 months to <18 years of age with atopic dermatitis (ad)

Conditions: Atopic Dermatitis

Summary: the primary objective of the study is to assess the long-term safety of dupilumab in pediatric participants with ad. the secondary objectives of the study are: * to assess the long-term efficacy of dupilumab in pediatric participants with ad * to assess the trough concentrations of functional dupilumab in serum and the immunogenicity in pediatric participants with ad after re-treatment with dupilumab optional pre-filled pen (pfp) sub-study in pediatric patients ≥2 to \<12 years of age with ad co-primary objectives are: * to evaluate the pharmacokinetic (pk) of dupilumab pfps * to evaluate the safety of dupilumab pfps secondary objective is: - to evaluate the immunogenicity of dupilumab pfps


Eligibility criteria:
key inclusion criteria: * participated in a prior dupilumab study in pediatric participants with ad and adequately completed the visits and assessments required for both the treatment and follow-up periods, as defined in the prior study protocol * pfp sub-study only: * age ≥2 to \<12 years at time of screening * body weight ≥5 kg and \<60 kg at time of screening * must have received the same dupilumab dose regimen to be used in the pfp sub-study during the previous 12 weeks in the main ole study using the prefilled syringe, as defined in the protocol key exclusion criteria: * participants who, during their participation in a prior dupilumab study developed an adverse event (ae) or serious adverse event (sae) deemed related to study drug which could indicate that continued treatment with study drug may present an unreasonable risk for the patient * participants, who during the participation in a prior dupilumab study, developed an ae that was deemed related to study drug and led to study treatment discontinuation, which in the opinion of the investigator or medical monitor could indicate that continued treatment with study drug may present an unreasonable risk for the patient * treatment with an investigational drug, other than dupilumab, within 8 weeks or within 5 half-lives (if known), whichever is longer, before the baseline visit * having used immunosuppressive/immunomodulating drugs within 4 weeks before the baseline visit * treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit * diagnosed active endoparasitic infections or at high risk of these infections * severe concomitant illness(es) that, in the investigator's judgment, would adversely affect the participant's participation in the study * pfp sub-study only: * poor compliance as defined by having missed 1 or more of the planned last 3 injections in the main ole study prior to entering the sub-study * switched dupilumab doses within the past 12 weeks * meet criteria for temporary/permanent discontinuation of study drug at time of screening into pfp sub-study, as defined in the protocol. note: other protocol defined inclusion / exclusion criteria may apply

Keywords: eczema
special drug use investigation for zefix (lamivudine) tablet (hbv cirrhosis)

Conditions: Hepatitis B, Chronic

Summary: the purpose of this study is to confirm efficacy and safety when administering lamivudine tablet alone in subjects with hepatitis b virus-induced liver cirrhosis.


Eligibility criteria:
inclusion criteria: * subjects with hepatitis b virus-induced liver cirrhosis, in whom lamivudine tablet was administered alone for 6 months or longer, or those in whom lamivudine tablet was expected to be administered alone for 6 months or longer exclusion criteria: * subjects previously enrolled in drug use investigation or special drug use investigation of lamivudine tablet * subjects with a history of hypersensitivity of the ingredients of lamivudine tablet