Kornimate/medical-research-clean huggingface dataset:
complliance and quality of life in asthma

Conditions: Asthma; Compliance, Patient; Quality of Life

Summary: a multicenter, open, non-interventional, prospective, clinical observational study on conformity to therapy and quality of life in asthma in patients living in greece

dry powder devices, available since 1970, have been developed to make inhalation simpler than pmdis and relieve the need for co-ordination of spraying and inhalation, which is particularly important for patient groups such as the elderly and children. in addition, dry powder devices do not contain propellant gases potentially hostile to the environment as they are activated by inhalation of the patient and do not cause cold sensation upon inhalation. today, the combination of inhaled corticosteroid (ics) and long-acting β2-inducer with an inhaler is the basic treatment for asthma6. the addition of long-acting β2-inducer (laba) to a daily inhaled corticosteroid regimen1: * improves the symptoms, * reduces nightly asthma symptoms, * improves pulmonary function, * reduces the use of β2-agonists for rapid action, * reduces the number of seizures, * does not increase the risk of hospitalizations due to asthma, * achieves clinical asthma control in more patients, faster and with less ics than would be required if ics were administered alone. the greater effectiveness of combination therapy has led to the development of stable combination inhalers that both glucocorticosteroids and laba (eg, fluticasone-salmeterol, budesonide-formoterol stable compounds) are concomitantly conveyed. stable combinations are more user-friendly for patients, potentially increasing compliance, and ensure that laba is always accompanied by glucocorticosteroid1. of the combinations available, the budesonide-formoterol combination can be used both as maintenance therapy and symptom relief due to the rapid onset of formoterol compared to salmeterol. both components of the budesonide-formoterol combination when administered are helpful in enhancing protection from severe seizures in patients receiving combination therapy for maintenance and improve the control of asthma at relatively low ics doses.

Eligibility criteria:
inclusion criteria: * male or female asthma patients over 18 years of age * compliance with treatment * compliance with study procedures * signed informed consent form * patients not satisfactorily controlled with inhaled corticosteroids and the use of inhaled short-acting β2-primers or patients already adequately controlled with both inhaled corticosteroids and long-acting β2-stimulants: 1. patients receiving ics inhaled and saba invoked 2. patients receiving inhaled ics and laba with separate devices each 3. patients receiving periodic and not continuously stable combination of ics and laba but not being treated for at least 1 month 4. patients who did not receive any treatment and the doctor decides to immediately start the fixed combination of ics and laba exclusion criteria: * male or female asthma patients under 18 years of age * unsigned patient consent * non-compliance with treatment * non-compliance in study procedures * copd patients (at any stage)
study of rapastinel as monotherapy in patients with major depressive disorder (mdd)

Conditions: Depressive Disorder, Major

Summary: the study will evaluate the efficacy, safety, and tolerability of 225 milligrams (mg) and 450 milligrams (mg) of rapastinel, compared to placebo in participants with major depressive disorder (mdd).


Eligibility criteria:
inclusion criteria: * meet diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) criteria for mdd * current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at visit 1 * treatment naive in the current episode or have inadequate response to 1-3 antidepressant therapies given at adequate dose and duration in the current episode * if female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hcg) pregnancy test exclusion criteria: * dsm-5-based diagnosis of any disorder other than mdd that was the primary focus of treatment within 6 months before visit 1 * lifetime history of meeting dsm-5 criteria for: 1. schizophrenia spectrum or other psychotic disorder 2. bipolar or related disorder 3. major neurocognitive disorder 4. neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent, follow study directions, or otherwise safely participate in the study 5. dissociative disorder 6. posttraumatic stress disorder 7. mdd with psychotic features * significant suicide risk, as judged by the investigator

Keywords: depression
comparing intra-vaginal culture of embryos to in-vitro culture of embryos with minimal stimulation

Conditions: Infertility

Summary: the purpose of this study is to evaluate implantation rate with intra-vaginal culture (ivc) with the invocell device versus traditional in-vitro fertilization (ivf) while using minimal stimulation protocols

this is a phase iv, single center randomized controlled trial evaluating intra-vaginal culture (ivc) using invocell versus traditional in-vitro fertilization (ivf) using oral stimulation or minimal gonadotropin stimulation protocols. the pilot aims to includes 40 women who will be randomized to either the intra-vaginal culture group (n=20) using invocell or to the traditional ivf group (n=20). primary aim is implantation rate, which is defined by number gestational sacs seen on early pregnancy ultrasound divided by number of embryos transferred. secondary aims are: * embryo quality, which is measured by system similar to the gardner grading system at cleavage stage. reported quality will be converted to the simplified sart embryo scoring system which provides an overall categorical embryo grade of "good", "fair" or "poor". * fertilization rate, which is defined by the total number of fertilized oocytes divided by total number of mature oocytes retrieved. this comparison will take place on day-3, as that is when the ivc embryos will be assessed. * clinical pregnancy rate, which is defined by the number of fetal poles with heartbeat seen on ultrasound divided by the number of embryos transferred. * live birth rate, which is defined by the number of living babies delivered divided by the number of transfers

Eligibility criteria:
inclusion criteria: * normal uterine cavity * one or more years of infertility * normal male partner semen analysis exclusion criteria: * age \ 37 years old * antral follicle count (afc) \<8 * abnormal male partner semen analysis or use of donor sperm * vaginal inflammation or genital (vaginal, uterine, tubal) infection * uncontrolled chronic disease (such as uncontrolled diabetes or hypertension) * uterine anatomic abnormalities * allergy to plastics or inability to use diaphragm retention device * untreated hydrosalpinx * current alcohol abuse (defined by \>14 drinks/week) * prior history of ivf cycle where fertilization did not occur * history of recurrent pregnancy loss
cognitive remediation plus aerobic exercise in schizophrenia treatment

Conditions: Schizophrenia

Summary: cognitive remediation (cr) and aerobic exercise have separately shown promising results in schizophrenia cognitive improvement, despite this, the impact in improving functionality is still limited. aerobic exercise increases brain derived neurotrophic factor (bdnf) levels, promoting neuronal and cognitive plasticity, which can maximize the impacts of cr. the aim of this randomized controlled trial is to study the efficacy of a 3-month intensive program that combines cr plus physical exercise comparing it to cognitive remediation plus a control activity.

cognitive remediation (cr) and physical exercise have separately shown promising results in schizophrenia cognitive improvement, despite this, the impact in improving functionality is still limited. physical exercise increases brain derived neurotrophic factor (bdnf) levels, promoting neuronal and cognitive plasticity, which can maximize the impact of cr. the aim of this project is to study the efficacy of an intensive program (3 months) that combines cr and physical exercise by a randomized controlled trial where 74 patients with chronic schizophrenia will be randomized to two groups: 1) cr plus physical exercise; 2) cr plus control activity (health promotion). primary outcome measures will be cognitive performance, functional outcome, negative symptoms and bdnf levels. measures will be blindly assessed at baseline, at 3 months follow up and at 15 months follow up. the investigators expect that: i) the cr plus physical exercise will be superior to cr plus control activity in improving cognition, functional outcome, negative symptoms and in increasing bdnf levels in the short and medium term (3 and 15 months); ii) changes in bdnf levels after the cr plus physical exercise will be an adequate biomarker of the cognitive improvement obtained with this treatment.

Eligibility criteria:
inclusion criteria: 1. a diagnosis by diagnostic and statistical manual of mental disorders of schizophrenia or schizoaffective disorder with a minimum of 10 years illness evolution/duration; 2. between 28 and 60 years of age; 3. clinically stable (no changes in psychotropic medication in the previous months, except for benzodiazepines) 4. sufficient acculturation and fluency in the spanish language to avoid invalidating research measures of thought, language, and speech disorder or of verbal cognitive abilities; 5. low physical activity, as measured by international physical activity questionnaire, ipaq; 6. signed informed consent exclusion criteria: 1. evidence of a known neurological disorder (e.g., epilepsy) or significant head injury; 2. evidence of substance use disorder within the previous 3 months; 3. mental retardation, i.e. premorbid intelligence quotient less than 70; 4. electroconvulsive therapy in previous 6 months. 5. somatic illnesses that contraindicate physical exercise.
a prospective validation study of albumin kinetics with tracer 123 i-hsa

Conditions: Healthy; SIRS

Summary: this is a prospective, validation study of a extempore made tracer compared with a commercial. studies with tracer have no medical effects but are used for studying human physiology, in this case pharmacokinetic variables of endogenous albumin distribution and turnover at different levels of inflammation. 1. primary objective: - do the extempore made tracer 123-iodine labeled albumin an commercially manufactured seralb-125 give identical values of calculated blood plasma volume and capillary leakage measured as transcapillary escape rate of albumin? 2. secondary objective: * how do three different measures of albumin turnover correlate in volunteers? * how do the pharmacokinetic parameters of endogenous albumin vary between the three study groups?


Eligibility criteria:
inclusion criteria: * healthy volunteers (treatment arm i) * on contraceptive agent and/or contraceptive device * visual peripheral veins * signed informed consent * planned for elective larger interabdominal surgery (treatment arm ii) * patients with a acute pancreatitis or cholecystitis (treatment arm iii) exclusion criteria: * pregnant women and/or lactating * allergy towards excipients in 123 i hsa or 125 i hsa * participates in another study involving radiation or stabile isotopes within a period of 60 days to study start * it is the opinion of the principle investigator that the patient/subject should not participate for his/hers own good

Keywords: plasma albumine plasma volume transcapillary escape rate inflammation circulation
phase iii study to evaluate the efficacy and safety of ad-209

Conditions: Hypertension,Essential

Summary: the purpose of this study is to evaluate the efficacy and safety of ad-209

condition or disease : hypertension

Eligibility criteria:
inclusion criteria: * signed informed consent * other inclusions applied exclusion criteria: * orthostatic hypotension with symptom * other exclusions applied
exparel vs. standard bupivicaine for abdominoplasty

Conditions: Pain, Postoperative

Summary: background \& study question: strategies for post-operative pain control that make use of various different types of medicines are advantageous both for patient comfort and for minimizing the use of opioid pain medicines and their associated side effects, which include drowsiness, nausea, and vomiting. a key element of these strategies is wound injection with local anesthetic (numbing medicine) at the time of surgery. local numbing procedures are used routinely in patients undergoing abdominoplasty (tummy tuck), most often with lidocaine or bupivacaine, which can last several hours. multiple studies have shown that locally injected pain medicines achieve better pain control, less opioid use, and faster return to normal activities, such that the use of one of these local anesthetic medicines is the current standard of care. exparel is an extended-release formulation of bupivacaine that can produce local pain relief for up to 72 hours. studies have shown it to provide better post-operative pain control and decreased use of opioid medications when compared to patients who did not receive any local numbing agents. exparel has been used successfully in a variety of surgical settings, including open colon surgery, laparoscopic gall bladder removal, abdominoplasty, and breast augmentation. its effectiveness has by and large been established in comparison to no local anesthetic. in this study, we seek to investigate the benefit of exparel compared to standard bupivacaine infiltration in patients undergoing abdominoplasty. study design: patients scheduled for abdominoplasty with the lead investigator will be offered inclusion in this study. consenting patients will be randomly assigned to standard bupivacaine or exparel by coin toss after their clinic visit. on the day of surgery, the only difference between patients assigned to one arm or the other is the local anesthetic used. the surgery itself and plan for general anesthesia will be similar. both groups will have the same pain medicines available after surgery. patients will be given a form on which to record twice-daily pain ratings and opioid narcotic needs for 3 days after surgery. for patients admitted after surgery, oral and iv narcotic use will be collected from their inpatient medical record. the primary outcome of interest is daily and cumulative pain scores through 3 days. a secondary endpoint is daily and total opioid use over 3 days. additional measures include the time to first post-operative use of opioid medication and incidence of any adverse side effects.


Eligibility criteria:
inclusion criteria: * adult men and women * scheduled for abdominoplasty exclusion criteria: * pregnant women * patients with allergy to amide-type local anesthetics

Keywords: pain, postoperative analgesia anesthesia, local abdominoplasty
clinical study of focal implant used for lower extremity post-angioplasty dissection

Conditions: Peripheral Artery Disease

Summary: this is a prospective, multicenter, randomized controlled trail using spot stenting to treat lower extremity post-angioplasty dissection.


Eligibility criteria:
inclusion criteria: 1. age 18 to 80 years,male or female 2. lower extremity atherosclerotic occlusive disease 3. after pta, angiography showed less than 30% residual stenosis of the target lesion (based on visual estimation), and there is one or more dissection(type a-f) 4. subjects are able to understand the purpose of the study, demonstrate full compliance with the procedure and follow-up and sign informed consent exclusion criteria: 1. the target lesion has been stented or previously treated with bypass surgery 2. acute thrombosis of the target vessel requires thrombolysis or thrombectomy, or has undergone local or systemic thrombolysis within 48 hours 3. cutting balloon, thrombectomy, plaque resection, brachytherapy, and laser therapy were planned 4. more than 30% residual stenosis of the inflow artery (based on visual estimation) after treatment, or there is no outflow artery in the target limb 5. the target lesion was too calcified to undergo pta or the guide wire could not pass anterograde through the target lesion 6. planned amputation on the target limb 7. severe allergy to anticoagulant drugs, antiplatelet drugs, contrast media and nitinol 8. uncontrollable infections 9. women who are pregnant or breastfeeding, or who plan to become pregnant during the duration of the trial 10. participating in clinical trials of any other drug or medical device and not yet out of the study 11. other circumstances not suitable for inclusion as judged by the investigator
improving representative payeeship for people with psychiatric disabilities and their families

Conditions: Schizophrenia; Bipolar Disorder; Major Depressive Disorder

Summary: representative payees, mostly family members, manage social security administration funds of more than one million people with psychiatric disabilities. although studies show payeeship can be used coercively, foster dependency, reduce work incentives, lead to family conflict and even violence, there has been little systematic research on how to lower these significant barriers to community integration. the investigators' long term goal is to promote recovery among adults with psychiatric disabilities who have payees by reducing downsides associated with what has been called "the nation's largest guardianship system." the investigators' objective in the current application is to evaluate a pilot-tested, stakeholder-informed intervention that is grounded in principles of psychiatric rehabilitation and encourages consumers with psychiatric disabilities and their family members to collaborate within the representative payee arrangement.

to do this, we will test the steps for achieving financial empowerment (safe) intervention by randomly assigning n=200 consumer-family payee dyads into one of two groups: (a) the safe intervention (n=100); or (b) a "usual care" control (n=100). the safe is a brief, 5 component educational intervention that aims to facilitate a cooperative consumer-payee relationship, increase accurate knowledge about representative payeeship, promote collaborative money management and effective budgeting, and prepare mutually developed plans for carrying out the payeeship in the future. we will interview people with psychiatric disabilities and their family payees at baseline and six-months. this study aims to examine the effects of the safe intervention on community participation, employment, and family support of adults with psychiatric disabilities who have family representative payees. our central hypothesis, based on strong preliminary data, is that the safe will benefit consumers by enhancing autonomy, boosting motivation to work, and reducing family conflict.

Eligibility criteria:
inclusion criteria: * for disability recipients: 1. meets dsm-iv criteria for schizophrenia, schizoaffective disorder, bipolar disorder, or depressive disorder with psychotic features; 2. age 18-65; 3. has a family member (parent or sibling) as a representative payee. * for payees: 1. has family member (child or sibling) with schizophrenia, schizoaffective disorder, bipolar disorder, or depressive disorder with psychotic features; and 2. is the family member's representative payee. exclusion criteria: * none.
prevalence of hepatitis c virus infection in hiv-infected children

Conditions: HIV Infections; Hepatitis C

Summary: the purpose of this study is to find out how many children who are infected with hiv are also infected with hepatitis c virus (hcv). hcv infection is a major health concern. hiv-infected adults who are co-infected with hcv appear to have more rapid hiv disease progression. there is little data on how widespread hcv is among children who are hiv-infected. information from this study will help determine the need for future hcv studies. this study also will obtain blood samples for future testing for other hepatitis viruses such as hepatitis g virus (hgv or gb virus c).

hcv infection is a major public health concern with worldwide seroprevalence estimated at 1 percent. hiv-infected adults co-infected with hcv appear to have accelerated hiv disease progression. there is little data on hcv prevalence in the pediatric hiv-infected population. this substudy will provide estimates of hcv prevalence among hiv-infected children and determine the need for future hcv natural history and treatment protocols. in addition, this substudy will archive samples from patients for future testing for other hepatitis viruses such as hepatitis g virus (hgv or gb virus c). patients participating in pactg 219c are selected randomly to enroll into pactg p1028s. patients who agree to participate have a single blood draw for hcv antibody (enzyme immunoassay-eia) testing and hcv rna (polymerase chain reaction-pcr) testing. an additional blood draw is necessary in the case of discordant results between the hcv eia and hcv pcr. hcv-negative patients have 1 study visit. patients with positive hcv test results have 2 visits. patients with discordant hcv test results have 2 or 3 visits.

Eligibility criteria:
inclusion criteria patients may be eligible for this substudy if they: * are between 1 year and 20 years of age. * were infected with hiv from the mother at or around the time of birth. * are enrolled in pactg 219c. * children known to be hcv-infected will be permitted to enter the substudy. exclusion criteria patients may not be eligible for this substudy if they: * have hemophilia. * contracted hiv through a route other than from the mother around the time of birth.

Keywords: hiv seropositivity hepatitis c polymerase chain reaction rna, viral prevalence disease transmission, vertical hepacivirus enzyme immunoassay gb virus c