Kornimate/medical-research-clean huggingface dataset:
topical rapamycin therapy to alleviate cutaneous manifestations of tuberous sclerosis complex (tsc) and neurofibromatosis i (nf1)

Conditions: Tuberous Sclerosis; Neurofibromatoses; Angiofibroma; Neurofibroma

Summary: this study is a prospective, randomized, double-blind, placebo-controlled evaluation of the safety of a topically applied formulation of rapamycin to cutaneous fibromatous lesions in subjects with tuberous sclerosis complex (tsc) and neurofibromatosis i (nf1). subjects will apply either a polyvinylidene fluoride (pvdf) coating (skincerity) containing rapamycin or the pvdf coating alone nightly to fibromatous lesions for a duration of six months. the primary goal of this study is to evaluate the safety of the topical product in patients with tsc and nf1. the secondary goal of this study is to evaluate the effectiveness of the topical product for treatment of cutaneous fibromatous lesions.


Eligibility criteria:
inclusion criteria: * subject is willing and able to comply with all trial requirements * subject is male or female and over 13 years of age * subject has a diagnosis of either tsc or nf1 and has visible fibromatous lesions (angiofibromas or neurofibromas) * female subjects of child-bearing potential must not be pregnant and must agree to use appropriate contraceptive methods for the duration of the trial exclusion criteria: * subject is currently receiving therapy with rapamycin or sirolimus * subject is receiving any form of immunosuppression or has previously experienced immune dysfunction * subject is currently participating in or has participated within the last 30 days in any clinical trial involving an investigational drug * subject has a known hypersensitivity to either the pvdf coating (skincerity®) or rapamycin * subject is a pregnant or nursing female

Keywords: tuberous sclerosis neurofibromatoses angiofibroma neurofibroma sirolimus
efficacy and safety of two doses of formoterol fumarate mdi (pt005) in patients with stable chronic obstructive pulmonary disease (copd), compared to foradil® aerolizer® as an active control

Conditions: COPD

Summary: the purpose of this study is to evaluate the safety and efficacy of inhaled formoterol fumarate (7.2 and 9.6 µg ex-actuator) compared to placebo and foradil aerolizer in patients with moderate to very severe chronic obstructive pulmonary disease (copd).


Eligibility criteria:
key inclusion criteria: * signed written informed consent * 40 - 80 years of age * fluency in written and spoken english * females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods * current/former smokers with at least a 10 pack-year history of cigarette smoking * a measured post- bronchodilator fev1/fvc ratio of \< or = 0.70 * a measured post- bronchodilator fev1 \> or = 750ml or 30% predicted and \< or = 80% of predicted normal values * competent at using the inhalation device key exclusion criteria: * women who are pregnant or lactating * primary diagnosis of asthma * alpha-1 antitrypsin deficiency as the cause of copd * active pulmonary diseases * prior lung volume reduction surgery * abnormal chest x-ray (or ct scan) not due to the presence of copd * hospitalized due to poorly controlled copd within 12 weeks of screening * poorly controlled copd, defined as the occurrence of acute worsening of copd requiring corticosteroids or antibiotics or acute worsening of copd requiring treatment prescribed by a physician within 6 weeks of screening or between screening and visit 2 * lower respiratory tract infection requiring antibiotics within 6 weeks of screening * clinically significant medical conditions that preclude participation in the study (e.g. clinically significant abnormal ecg or uncontrolled hypertension) * positive hepatitis b surface antigen or hepatitis c antibody * cancer that has not been in complete remission for at least 5 years * history of hypersensitivity to any beta2-agonists or any study drug component * history of severe milk protein allergy * known or suspected history of alcohol or drug abuse * medically unable to withhold short acting bronchodilators for 8-hours * use of prohibited medications prior to screening and during the study as specified in the protocol * receiving long-term-oxygen or nocturnal oxygen therapy for \>12 hours a day * participation in acute phase of pulmonary rehabilitation within 4 weeks of screening or will enter acute phase of pulmonary rehabilitation program during study * unable to comply with study procedures * prior participation in a pearl pt005 study * requires use of a spacer due to poor hand-to-breath coordination
training concepts in emergency ultrasonography

Conditions: Medical Education in Emergency Ultrasound

Summary: emergency ultrasound examinations are increasingly important diagnostic tools in emergency and critical care medicine. this study wants to analyze different types of education for undergraduate students. any method of medical training will be proved theoretical and in clinical practice.

this prospective educational study wants to analyze different methods of education for undergraduate medical students. method a: theoretical training will be scheduled for 2 hours with lectures in basics of emergency ultrasound. after the theoretical education the students will obtain a bedside-teaching on intensive care unit for 4 hours. method b: theoretical training will be scheduled for 3 hours and included lectures in echocardiography, lung ultrasound and abdominal ultrasound. after the theoretical education the students will obtain a bedside-teaching on intensive care unit for 3 hours. method c: theoretical training will be scheduled for 3 hours and included lectures in echocardiography, lung ultrasound and abdominal ultrasound. after the theoretical education the students will obtain a hands-on-training in healthy volunteers for 3 hours. the acquired knowledge and practical skills will be analyzed by a multiple-choice exam (5 mc-questions, 5 video sequences) and a practical exam (five tasks). any method of training will be proved at the end theoretical and in clinical practice.

Eligibility criteria:
inclusion criteria: * medical students exclusion criteria: * no
acceptance and commitment therapy (act) and carers

Conditions: Brain Injuries

Summary: background: research has extensively documented the adverse impact that caring for an individual with an acquired brain injury can have including financial difficulties, social isolation, family tension and conflict, relationship difficulties, role adjustment and psychological distress (foster et al., 2012). research has indicated that acceptance and commitment therapy (act) shows promise for increasing wellbeing and psychological flexibility in caregivers and could be a useful intervention for use with this population. aims: the primary aim of this study is to investigate the feasibility of using an act intervention to enhance the wellbeing and the psychological flexibility of carers using the population, intervention, control, and outcomes (pico) framework. methods: the current study is a randomised control design, exploring the feasibility of comparing the efficacy of an act intervention to enhanced treatment as usual (etau), to improve the wellbeing of the carers of adults with an acquired brain injury (abi). participants will be recruited from the brain injury rehabilitation trust (birt) in glasgow, scotland and randomly assigned to either an act intervention group or tau control group. both will be assessed in parallel to one another completing a range of baseline and post-baseline measures. applications: this feasibility study will provide information for further research on the utilisation of an act intervention to improve the wellbeing of carers and whether this is an acceptable intervention for this population.


Eligibility criteria:
inclusion criteria: * full time or part time carer for an adult with an acquired brain injury exclusion criteria: * learning disability * not proficient in english

Keywords: acceptance and commitment therapy
a study of motexafin gadolinium for the treatment of chronic lymphocytic leukemia (cll)

Conditions: Leukemia; Leukemia, Lymphocytic, Chronic

Summary: the purpose of this study is to determine if the drug motexafin gadolinium will be an effective treatment for patients who have chronic lymphocytic leukemia (cll) that has come back after treatment or that has stopped responding to treatment.


Eligibility criteria:
inclusion criteria: * at least 18 years old * refractory or relapsed cll * ecog performance status score of 0, 1, or 2 * each patient must sign a study-specific informed consent form exclusion criteria: laboratory values of: * platelet count \<30,000/ul * ast or alt \>2 x the upper limit of normal (uln) * total bilirubin \>2 x uln * creatinine \>2.0 mg/dl * chemotherapy, radiation therapy, immunotherapy, systemic corticosteroids, or systemic biologic anticancer therapy within 21 days before beginning study treatment * women who are pregnant or lactating

Keywords: cll chronic lymphocytic leukemia relapsed chronic lymphocytic leukemia refractory chronic lymphocytic leukemia leukemia motexafin gadolinium chronic leukemia lymphocytic leukemia, chronic
goal setting and mobile-based self-management tool to improve diet quality of people with high blood pressure

Conditions: Blood Pressure, High

Summary: smart goal setting is a patient-led method that can help improve execution and facilitate behavioral changes. functions such as diet tracking, interaction, and feedback in smartphone application may help enhance patient compliance. this study aims to explore the nutrition intervention measures of smart goal setting combined with smartphone applications for daily self-management on the effect of improving diet quality of people with high blood pressure.


Eligibility criteria:
inclusion criteria: * age 20-70; * hypertension diagnosis, or high blood pressure (sbp between 120-139 mmhg and/or dbp between 80-89 mmhg); * eating an unhealthy diet (estimated dash score \< 6) ; * owning a smartphone and able to operate it proficiently; * sign the informed consent. exclusion criteria: * severe cardiovascular and respiratory diseases, such as acute myocardial infarction, tachyarrhythmia, pulmonary edema, and severe aortic stenosis; * acute phase of cardiovascular and cerebrovascular diseases; * uncontrolled blood pressure; * diagnosed mental diseases or epilepsy; * cardiac pacemaker implantation; * allergic constitutions; * pregnant women or planning to become pregnant; * individuals who have participated in other clinical studies within the past 3 months; * refuse to sign the informed consent.

Keywords: goal setting
a study to evaluate the use of bosentan in patients with exercise induced pulmonary arterial hypertension associated with connective tissue disease

Conditions: Hypertension, Pulmonary; Connective Tissue Disease

Summary: the primary objectives of this exploratory study are to evaluate the effects of bosentan on hemodynamics (via cardiac catheterization) during exercise in patients with pulmonary arterial hypertension (pah) who have abnormal hemodynamics during exercise but normal hemodynamics at rest. the authors hypothesize that early treatment may change the course of disease progression by improving hemodynamics during exercise, thus delaying disease progression.


Eligibility criteria:
inclusion criteria: * men or women ≥ 18 years of age * for female patients, only non-pregnant women who are surgically sterile, postmenopausal or have documented infertility (over 50 years of age and amenorrheic for at least 1 year), or those of childbearing potential using one of the following methods of contraception: * barrier-type devices (e.g., condom, diaphragm) used only in combination with a spermicide. a double-barrier method is recommended. * intrauterine devices (iuds) * oral contraceptives, if used in combination with a barrier method * body weight of 40 kg or higher * patients diagnosed with connective tissue disease * hemodynamics at rest, based on cardiac catheterization, should be as follows: * mean pulmonary arterial pressure (mpap) : 18 - 25 mmhg * pcwp ≤ 15 mmhg * hemodynamics during exercise, based on cardiac catheterization, should be as follows: mpap \> 30 mmhg * provide written informed consent exclusion criteria: * pah associated with any other condition * severe obstructive lung disease : fev1∕ fvc \<0.5 * total lung capacity \<60% of normal predicted value * unable or unwilling have a cardiac catheterization procedure * acute or chronic impairment (other than dyspnea), limiting the ability to comply with study requirements (6-mwt) * psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with study requirements * moderate to severe hepatic impairment, i.e., child-pugh class b or c * ast and ∕or alt \> 3 times uln * hemoglobin concentration \> 25% below the lower limit of normal * systolic blood pressure \< 85 mm hg * pregnancy or breast-feeding * treatment or planned treatment with another investigational drug * treatment with an endothelin receptor antagonist, phosphodiesterase type 5 inhibitor, or with prostanoids (excluding acute administration during a catheterization procedure to test vascular reactivity) within 2 months of inclusion * treatment with calcineurin-inhibitors (i.e., cyclosporine a and tacrolimus), fluconazole, glibenclamide (glyburide) within 1 week of study start; * known hypersensitivity to bosentan or any of the excipients
a brief cognitive intervention after intrusive memories of trauma with young refugees: an extension

Conditions: Intrusive Memories of Trauma, Symptom of Post Traumatic Stress Disorder (Criterion B1)

Summary: this research study is designed to investigate the use of a simple cognitive task (a memory cue and 10 minute time gap, followed by playing the computer game "tetris") for decreasing the number of intrusive memories of trauma among young refugees and asylum seekers. the design is a single case experimental ab design with optional replication (abab). participants will aim to complete a no-intervention phase ('a': baseline phase) of one week followed by a one-week intervention phase ('b'), including a one-session intervention with a researcher comprising the simple cognitive task, followed by instructions to continue to use the technique self-guided in the subsequent week. follow ups are conducted after each week to monitor the occurrence of intrusive memories of trauma in a pen-and-paper diary. it is predicted that participants will report fewer intrusive memories during the intervention phase than during the preceding baseline phase.

this research study follows from clinicaltrials.gov id: nct03525158, with a focus on the abab design and adding additional questions e.g. on concentration, emotion and functioning, and with the possibility of focusing on 1 intrusive memory at a time with associated distress ratings as part of the procedure.

Eligibility criteria:
inclusion criteria: * refugee or asylum seeker * experiencing intrusive memories of trauma * have access to a smartphone * able to speak or read the study material in swedish, english, arabic or farsi * able to attend five to six meetings with a researcher exclusion criteria: * exhibit psychotic symptoms or other symptoms of severe mental illness
facial distortion model and instrument assisted soft tissue mobilization techniques

Conditions: Meniscus Injury

Summary: to compare the effects of facial distortion model and equipment assisted soft tissue mobilization techniques on the treatment process, which are among the applications in the rehabilitation process after meniscus repair.

it is possible that pain, rom, lower extremity flexibility and knee functions will be negatively affected after arthroscopic meniscus repair. this study searches and compares the effectiveness of fascial distortion model (fdm) and iastm methods for these parameters that can be affected.

Eligibility criteria:
inclusion criteria: * the meniscus rupture and suspected magnetic resonance (mr) were diagnosed and operated by the surgeon during arthroscopy. * those treated with the same surgical technique * can walk independently before the operation * can continue treatment for 4 weeks * without chondral damage * can continue treatment for 4 weeks * those who have not had lower extremity surgery before * no fracture to prevent load transfer in the last 6 months * there is no full rupture of any ligament in the knee * without knee instability * those without abnormal changes in q angle * according to cooper classification, meniscus affected area is not in a and f regions. * without protruded or extruded herniated disc * there is no contract in the directory exclusion criteria: * can not continue treatment for 4 weeks

Keywords: iastm fdm meniscus repair
"efficacy and safety of levofloxacin vs isoniazid in latent tuberculosis infection in liver transplant patients".

Conditions: Latent Tuberculosis Infection; Infection in Solid Organ Transplant Recipients

Summary: a multicenter, prospective, non-inferiority, randomized and open clinical trial comparing levofloxacin with isoniazid in the treatment of latent tuberculosis infection in patients eligible for liver transplantation. patients over 18 years of age on the waiting list for liver transplantation. sample size: n=870 patients. hypothesis levofloxacin treatment of latent tuberculosis infection, begun while on the waiting list for liver transplantation, is safer and not less effective than isoniazid treatment begun after transplantation when liver function is stable.

primary objective 1. to demonstrate that the incidence of tuberculosis in patients with latent tuberculosis infection and treated with levofloxacin is not higher than that observed in patients treated with isoniazid. secondary objective 2. to demonstrate that the efficacy of levofloxacin is not limited by adverse effects, paying particular attention to hepatotoxicity.

Eligibility criteria:
inclusion criteria: liver transplantation candidates with age ≥ 18 years, no clinical or radiological evidence of active tuberculosis and negative pregnancy test (if applicable)who must meet one or more of the following criteria: * ppd skin test (initial or after a "booster effect") \>5 mm. alternatively, the determination may be made by the interferon gamma (ifn-g) production in ppd-stimulated lymphocytes using the quantiferon-tb or elispot assays. * past history of tuberculosis not properly treated. * past history of contact with a patient with active tb. * chest x-ray consistent with past untreated tb (apical fibronodular lesions, calcified solitary nodule, calcified lymph nodes or pleural thickening). the patient must give their written informed consent. exclusion criteria: * lack of consent to participate in the study. * intolerance or allergy to levofloxacin or to isoniazid. * documented contact with tuberculosis resistant to levofloxacin or to isoniazid. * treatment in the previous month with drugs with potential activity against mycobacterium tuberculosis, (especially quinolones).

Keywords: prophylaxis tuberculosis transplant recipients transplant waiting list
baricitinib healing effect in early polymyalgia rheumatica

Conditions: Polymyalgia Rheumatic (PMR)

Summary: patients with recent pmr(6 months or less) with a pmr-as \>17 and no oral or parenteral gcs during the past 2 weeks (at least) will be included. treatment with oral baricitinib 4mg or placebo during 12 weeks and then, if pmr-as≤10, they will receive baricitinib 2 mg for 12 weeks and then will stop treatment. no rescue is allowed before week 4 (visit 3) but patients may receive up to 2 intra-articular or soft tissue injections of gcs until week 4 according to investigator's opinion. from week 4 to week 12, steroids will be proposed as a rescue for both arms at investigators' discretion and according to pmr-as.


Eligibility criteria:
inclusion criteria: * at least 50 years of age * fulfilling acr/eular criteria for pmr * disease duration ≤6 months * no oral or parenteral steroid since ≥ 2 weeks prior to randomization * pmr-as \>17 * absence of connective tissue diseases or vasculitis * able to give informed consent exclusion criteria: * clinical symptoms of giant cell arteritis * uncontrolled high blood pressure or cardiovascular disease * clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to pmr * planned major surgical procedure during the study. * history of malignant neoplasm within the last 5 years (or 3 years in case of cervical carcinoma, basal cell or squamous epithelial skin cancer resected with no evidence of recurrence or metastatic disease). * current active uncontrolled infection * detailed exclusion criteria related to prior or concomitant therapy, general safety and laboratory data are reported in the protocol
lowsalt4life: a mobile application to reduce sodium intake and blood pressure

Conditions: Hypertension; Blood Pressure

Summary: this research is being done to learn if a smartphone app with and without a just in time adaptive intervention (jitai) can help patients with hypertension manage their sodium intake and improve their blood pressure.

the primary and secondary outcomes will be determined in months 1 \& 2. participants will continue for another 4 months and during that time data for exploratory measures will be collected. during the first 2 months of the study, a micro-randomized trial (mrt) will be performed within the app+jitai group (n=200). this mrt is designed to learn which push notification messages effectively prompt the user to interact with the appropriate content within the mobile application.

Eligibility criteria:
inclusion criteria: 1. diagnosed with essential hypertension (htn) by a medical provider and are on stable doses of antihypertensive therapy for at least three months prior to enrollment as documented in the electronic health record (ehr) and confirmed by participant self-report. 2. a smartphone with a compatible apple or android operating system installed and able to download and use lowsalt4life app including accepting all permissions and willing to allow the mobile applications to send push notifications 3. a valid email address 4. fluent in spoken and written english exclusion criteria: 1. unstable symptoms or markedly elevated blood pressure (bp) at enrollment (defined as systolic bp\>180 mmhg, diastolic bp\>120 mmhg) 2. contraindication to a sodium restriction diet 3. an estimated sodium intake less than 1,500mg per day 4. known secondary causes of htn (e.g., adrenal insufficiency, pheochromocytoma) 5. estimated glomerular filtration rate (egfr) \<30 or end-stage renal disease on dialysis 6. heart failure 7. inability to use withings devices (blood pressure cuff and scale) due to equipment limitations or contraindications 8. currently pregnant or intent to become pregnant during the study period

Keywords: dietary sodium