Kornimate/medical-research-clean huggingface dataset:
preventing depression in methadone maintenance patients receiving hepatitis c treatment - 1

Conditions: Depressive Disorder, Major; Hepatitis C

Summary: the purpose of this study is develop and test a cognitive-behavioral intervention to prevent depression in methadone maintenance patients receiving medical treatment for hepatitis c.

the purpose of this study is to develop a cbt-d intervention tailored to meet the needs of mmt patients undergoing antiviral treatment for hepatitis c. in the first phase of this project (year 1), we will develop and pilot the intervention with 20 patients. in the second phase of the project (years 2 and 3), we will conduct a preliminary, randomized trial with 60 mmt patients to examine the efficacy of the cbt-d intervention relative to standard care condition (sc). we expect that, relative to the sc condition, participants randomized to the cbt-d condition will have decreased likelihood of depression-related antiviral treatment failure, will report lower levels of depressive symptoms, will complete more ifn injections, will have lower hcv rna levels, and will have fewer illicit drug use days. if the efficacy of this intervention can be established in this trial and in subsequent clinical trials, mmt patients who elect to undergo antiviral therapy will have a valuable adjunct or alternative to the use of antidepressants to prevent depression. if found to be efficacious, this intervention will maximize the receipt of ifn treatment by mmt patients, thereby aiding in the prevention of liver failure, hepatocellular carcinoma, and liver-related death among those with hcv.

Eligibility criteria:
inclusion criteria: * currently undergoing hcv treatment at rih * enrolled in mmt for at least 6 months exclusion criteria: * current major depressive episode * current suicidality * currently taking antidepressant medication * received hcv treatment in past

Keywords: hepatitis c, depressive symptoms
decision support interventions (desi) for prostate cancer screening - study 1

Conditions: Healthy Men Age 50 Who Are Considering PSA Screening

Summary: in this study we will compare 3 strategies for systematic delivery of prostate cancer screening decision support interventions (desi) to usual care and examine their impact on screening decisions and subsequent healthcare utilization using a randomized control design. we hypothesize men who are given the opportunity to review a desi by one of the 3 strategies will be less likely to opt for prostate cancer screening, and will have lower subsequent healthcare utilization than men in the control group.

we will use a randomized experimental design to compare the effects of 3 different strategies to implement a prostate cancer screening decision support intervention (desi) with a control condition in primary care in 2 clinical systems - pamf (palo alto medical foundation) and unc. the primary outcomes of interest are men's screening decisions and their subsequent healthcare utilization. secondary outcomes include the likelihood that they review the desi and their decision-specific knowledge. the 3 strategies selected by the pamf and unc health systems are: (1) mailing men a desi in dvd; (2) inviting men to participate in a shared (group) medical appointment (sma) to watch and discuss the desi with a healthcare provider and other men; and (3) providing men options by inviting them to a sma while also providing them a desi in dvd which they can use individually if they are unable or choose not to attend a sma. the 3 groups will be compared to a control condition that does not receive a desi but will be encouraged to discuss prostate cancer screening with their physician. because of its significantly larger patient population, the pamf site will also evaluate these outcomes by targeting screening-naïve patients on their 50th birthday, when they first become guideline eligible to consider prostate cancer screening.

Eligibility criteria:
inclusion criteria: * age 50 or older * do not have a prostate diagnosis * have not had a psa test in the past 10 months * have not seen their primary care physicians in the last 3 months exclusion criteria: * women

Keywords: prostate cancer decision support intervention (desi) shared medical appointments (sma) comparative effectiveness research (cer)
small dense low-density lipoprotein in patients with prediabetes and type 2 diabetes

Conditions: Prediabetes / Type 2 Diabetes

Summary: it is known that small dense ldl particles are associated with an increased cardiovascular risk. ldl particles can be separated by gradient gel electrophoresis (gge) according to their size. the risk to suffer from coronary heart disease is 3-7 fold elevated in subjects with small dense ldl particles compared to subjects with large ldl particles. this study aims at evaluating the predictive value of small dense ldl particles in patients with prediabetes and type 2 diabetes mellitus concerning future changes in intima media thickness, flow-mediated dilation and other risk factors of atherosclerosis (e.g. insulin resistance). 60 patients with prediabetes or type 2 diabetes will be recruited for the study. assessment will include medical history (risk factors), physical examination (blood pressure, bmi, waist-to-hip ratio), collection of serum, oral glucose tolerance test, measurement of intima media thickness and endothelial dysfunction by ultrasound. all measurements will be repeated after 2 years. data will be analysed to assess whether the amount of small dense ldl particles can predict further structural and functional changes of the cardiovascular system or changes in the severity of the disease (insulin resistance).


Eligibility criteria:
inclusion criteria: - male gender * impaired fasting glucose or type 2 diabetes (ada criteria) * bmi \> 25 kg/m2 * given informed consent exclusion criteria: - hba1c \> 9.0% * insulin therapy * fasting glucose \> 11mmol/l * total cholesterol \> 6.5 mmol/l or triglycerides \> 2.5 mmol/l * malignant or severe renal, hepatic, pulmonary, neurological or psychiatric disease * alcohol or drug abuse * hiv infection.
[18f]florbetazine ([18f]92) for beta amyloid pet imaging in alzheimer's disease

Conditions: Alzheimer's Disease

Summary: \[18f\]florbetazine (\[18f\]92) is a molecularly targeted imaging agent for aβ protein with a novel diaryl-azine scaffold. it has shown specific binding affinity to aβ aggregates in postmortem human ad brains and excellent brain pharmacokinetic properties with little non-specific retention in white matter in animal studies and a limited number of patients with alzheimer's disease (ad). the purpose of the current study is to examine the binding properties of \[18f\]florbetazine in human subjects and to compare the cortical and white matter binding with \[11c\]pib or \[18f\]florbetapir in the same subjects. imaging of the brain will be completed in healthy adult normal control participants and participants with cognitive impairment (including probable ad and dementia due to other conditions) to characterize \[18f\]florbetazine uptake in the brain and its binding properties. \[11c\]pib or \[18f\]florbetapir pet imaging along with mri will be completed in the same participants and the data will be compared with 18f-\[18f\]florbetazine.


Eligibility criteria:
inclusion criteria: * male or female * age ≥ 40 years * healthy participants or patients with probable alzheimer's disease or with dementia due to other causes exclusion criteria: * has allergy to \[18f\]florbetazine or any of its excipients ; * has hypersensitivity to \[11c\]pib or any of its excipients ; * incapable of providing written informed consent or lacking a legally authorized representative (lar) to provide informed consent ; * unwilling or unable to undergo pet scans tracer injections ; * unwilling or unable to undergo mri; * any condition that, in the investigator's opinion, could increase the risk to the participant, limit the participant's ability to tolerate the research procedures, or interfere with the collection/analysis of the data (e.g., renal or liver failure, advanced cancer); * women who are currently pregnant or breastfeeding;
effects of sensomotoric insoles on postural control in elderly people

Conditions: Sensorimotor Gait Disorder

Summary: people with weak balance ability or subjective feeling of dizziness and unsure gait are separated into 3 training-groups. one group is getting no insoles, the second group is getting modern sensomotoric insoles, and the third group is getting normal standard insoles. all are passing a 6 week proprioceptive training. main outcome measurements are posturography at baseline, 3 weeks and 6 weeks. secondary measurements are abc-scale, tinetti gait and balance test and functional reach test at baseline and after 6 weeks.

people with weak balance ability or subjective feeling of dizziness and unsure gait are separated into 3 training-groups. exclusion criteria are structural neuropathic cause for dizziness, severe ocular deficience, cochlear causes for dizziness. the 3 groups differ in following criteria: group 1: gets basic insoles after 3-d-scan of the foot group 2: gets sensomotoric insoles (jahrling) after 3-d-scan of the foot. group 3: control-group = no insoles alle groups are doing a 6 weeks proprioceptive training 2 times a week for 45min. balance-ability is measured by a posturographic plate prior to the training, after 3 weeks training and after 6 weeks of training. abc-score, tinetti gait and balance test and functional reach test are secondary outcome measurements and are evaluated prior the training and after 6 weeks of training.

Eligibility criteria:
inclusion criteria: abc-scale \< 70% functional reach test \< 30cm subjective feeling of unsure gait or several falls in the last 5 years exclusion criteria: structural pathologies in the balance system neuropathologies like polyneuropathy

Keywords: sensomotoric insoles postural control proprioceptive insoles insoles
metabolic syndrome and degenerate meniscus tears

Conditions: Metabolic Syndrome; Meniscus; Degeneration

Summary: the aim is to determine the outcomes of calorie-restricted diet and exercise intervention; libitum diet and waiting list control; early arthroscopic partial meniscectomy(apm) or delayed apm effect on mets patients with degenerate menisucus lesions.

the investigators recruited 180 patients with metabolic syndrome and knee symptoms with degenerate meniscus lesions by mri from orthopaedics department from june 2017 to march 2020 at first affiliated hospital of jinzhou medical university. participants were diagnosed with mets and degenerate meniscus tear with a mild or no osteoarthritis kl\<2 verified by x ray. participants were randomly dividied into calorie-restricted diet and exercise intervention group; libitum diet and waiting list control group; early apm (syndrome within 3-6 months) group or a delayed apm(syndrome more than 6 months) group as a computer sequenced number. the primary outcome was the change in metabolic syndrome components and knee function score of womac, koos,womet,ikdc were determined by two fixed orthopadic surgeons who were blinded to the intervention.

Eligibility criteria:
inclusion criteria: * must be age between 35 and 70 years old; * clinical diagnosis of metabolic syndrome; * clinical diagnosis of 3 grade degneration meniscus leisons; exclusion criteria: * must be able to have no acute knee injury such as car crash or acute sports injury; * must be able to have no knee surgeries history; * must be able to have no rheumatoid arthritis or serious knee osteoarthritis with deformity; * must be able to have no contraindications to mri; * must be able to have no severe cardiopulmonary disease; * must be able to have no musculoskeletal or neuromuscular impairments ; * must be able to have good visual, hearing, or cognitive;

Keywords: metabolic syndrome degenerate meniscus lesions calorie restricted diet exercise arthroscopic partial meniscectomy
glycosaminoglycan scores as early detection biomarkers in bladder urothelial carcinoma

Conditions: Bladder Cancer

Summary: early detection of bladder cancer (bca) is considered an effective strategy to curb mortality from the disease. however, current urinary biomarkers have insufficient specificity to warrant bca screening. urine free glycosaminoglycan profiles (or gagomes) are promising noninvasive biomarkers of cancer metabolism. in this study, samples are obtained from patients with bca and controls to compare the glycosaminoglycan profiles between groups.


Eligibility criteria:
cases (bladder cancer \[bca\]) inclusion criteria: * primary bca diagnosis at cystoscopy, planned for turb exclusion criteria: * no histopathological diagnosis of bcata-t4 n0-2 mx-0 after turb controls (no evidence of disease \[ned\]) inclusion criteria: * in follow-up with cystoscopy after treatment ta-t3 n0-2 m0 bca or upper tract urothelial cancer no evidence of disease at cystoscopy for at least 6 months prior to inclusion * no history of cancer except urothelial exclusion criteria: * positive cytology at inclusion visit * intravesical instillation therapy during 6 months prior to inclusion visit
multiple-portal vats versus uniportal vats lobectomy for non-small cell lung cancer

Conditions: Non Small Cell Lung Cancer

Summary: this study evaluate multiple-portal vats and uniportal vats lobectomy for nsclc, half of participants will receive multiple vats, while the other half will receive uniportal vats lobectomy.

conventional vats and uniportal vats lobectomy can be performed each for nsclc. conventional vats lobectomy employ 3 or 4 ports for completing the operation. usually the camera port is performed at the seventh or eighth intercostals space within the trocar, so it's easy to cause the intercostals nerve and vessel injure, and still create obvious pain. however, the lobectomy for lung cancer can be accomplished with a single incision. according to the initial results, uniportal vats (uvats) lobectomy procedure has been wide adopted by less acess trauma, relieve postoperative pain. but these were retrospective and descriptive, not randomized study. further randomized control studies will be required to demonstrate that there are more benefits in uvats techniques compared with conventional vats for lobectomy.

Eligibility criteria:
inclusion criteria: * patients with clinical diagnosis of primary lung cancer with the age between 35 and 75 years old; * patients with tumor size ≤5cm，clinically staged t1-2n0-1m0，prepared for lobectomy and mediastinal lymph node dissection; * patients with an american society of anesthesiology score of 0-1. exclusion criteria: * patients with n2 or n3 positive or distant metastasis. * patients who had undergone neoadjuvant chemotherapy. * patients with tumor invasion to the peripheral structures. * patients with previous history of thoracic operations. * patients with serious thoracic adhesion. * patients who will undergo pneumonectomy, sleeve lobectomy, segmentectomy, wedge resection. * patients with preexisting chronic obstructive pulmonarydisease, asthma, or interstitial lung disease; * patients with cardiac, hepatic, or renal dysfunction;

Keywords: cvats uvats perioperative effect ergonomic influence
study of the effectiveness of vestibular stimulation treatment in the depressive phase of bipolar disorder

Conditions: Bipolar Disorder; Depression, Bipolar

Summary: vestibular stimulation has been shown to be a very effective noninvasive treatment for major depression. bipolar disorder is a mental illness that presents cyclic sequences of depressive and euphoric states. depressive phases of bipolar disorder are difficult to treat and usually are resistant to actual available treatments. this study investigates the effectiveness of a particular technique of vestibular stimulation in a group of 120 bipolar type i and ii patients. after randomization 60 of them will receive specific vestibular stimulation (experimental group) and 60 will receive a sham vestibular stimulation.the study will conducted in vest brain, centro de estudios neurovestibulares, in chile.


Eligibility criteria:
inclusion criteria: * males * females * 3 previous weeks with depression symptoms. * bipolar disorder type i actual depressive phase * bipolar disorder type ii actual depressive phase * montgomery asberg depression scale(madrs) score equal or more than 20 * stable psychiatric medication during 2 weeks previous the recruitment exclusion criteria: * pregnancy * neurologic disorder * drugs or alcohol abuse during the 2 weeks previous the recruitment * presence of maniac state(young mania scale score more than 7)

Keywords: depression, bipolar disorder
add-on effects of tiotropium over formoterol in exercise tolerance on chronic obstructive pulmonary disease patients

Conditions: Pulmonary Disease, Chronic Obstructive; Chronic Bronchitis; Pulmonary Emphysema

Summary: the primary objective is to comparatively evaluate the isolated effects of a long-acting beta2-adrenergic (formoterol fumarate 12µg b.i.d. via aeroliser) and combined with a long-acting anti-cholinergic (tiotropium bromide 18µg o.d via handihaler) on breathlessness, dynamic hyperinflation and exercise tolerance in patients with advanced, but stable, chronic obstructive pulmonary disease. the study hypothesis is that combining long acting bronchodilators with different action mechanisms would promote synergistic effects on clinical outcomes.

this will be a single center, randomized, double-blind study consisting of two 2-week treatment periods separated by a 5-7 days washout phase without long-acting bronchodilators. eligible patients who complete the one week screening phase will be randomized to one of two treatment sequences: 1) formoterol --\> formoterol + tiotropium or 2) formoterol + tiotropium --\> formoterol. during the treatment periods, patients will be allowed to use a short-acting beta2-adrenergic+short-acting anticholinergic as rescue medication (salbutamol+ipratropium via mdi)

Eligibility criteria:
inclusion criteria: * copd patients aged ≥ 40 years with stable moderate-to-severe airflow obstruction (fev1 \< 70% and fev1/fvc ≤ 70% of predicted normal value) post-bronchodilator * presenting with a long history of smoking (\> 20 pack-years) and chronic breathlessness (baseline dyspnoea index total score \< 9) exclusion criteria: * significant cardiovascular disease, hospitalization for copd exacerbation or presence of a respiratory tract infection within 1 month of screening * current or childhood asthma * a history of allergic rhinitis or other atopic disease * inability to interrupt usual bronchodilator medication * use of oral steroids within a month before screening * need for long-term oxygen therapy, arterial oxygen saturation \< 85% at rest anemia, hypo- and hyperthyroidism, hyperadrenergic state * uncontrolled insulin dependent diabetes mellitus, malignancy, or any disease or condition which limits exercise performance other than copd * change in inhaled corticosteroid or theophylline use within 1 month prior to screening

Keywords: pulmonary disease, chronic obstructive tiotropium formoterol bronchodilator agents exercise tolerance randomized controlled trial [publication type] copd
discovering factors in the clinical study journey of patients with ocd

Conditions: OCD; Obsessive-Compulsive Disorder

Summary: this research aims to collect comprehensive data on the clinical trial experience of ocd patients. its goal is to identify the factors that limit patients' ability to join or complete a trial successfully. clinical trial participation often favors specific demographic groups, and limited research exists on the impact of trial attributes on participation. therefore, this study aims to analyze data from various demographic groups and identify any recurring trends that could provide valuable insights for future ocd patients.


Eligibility criteria:
inclusion criteria: * ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed. * participant has a diagnosis of ocd. * willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study. exclusion criteria: * pregnant or lactating woman * enrolled in another research study * any mental or medical condition that prevents the patient from giving informed consent or participating in the trial

Keywords: ocd obsessive-compulsive disorder
rtms for suicidality in opioid use disorder

Conditions: Major Depressive Disorder; Opioid-use Disorder

Summary: this trial is a randomized, double blind, controlled pilot study that will compare bilateral theta burst stimulation (tbs) and sham treatment for patients with opioid use disorder (oud) and major depressive disorder (mdd) experiencing suicidality.

repetitive transcranial magnetic stimulation (rtms) to the dorsolateral prefrontal cortex (dlpfc) is used therapeutically in major depressive disorder resistant to standard treatments, and recently also shown to be effective in reducing suicidality with a bilateral approach. recently, a new form of rtms has been developed called theta burst stimulation (tbs) which requires a much shorter daily treatment duration and has been found to be non-inferior to standard rtms. the investigators propose to conduct a randomized controlled clinical trial of a daily, 20 session course of bilateral tbs versus sham stimulation in the treatment of suicidality in patients with oud and mdd. the investigators will explore whether tbs can have other clinical effects on decreasing symptoms of mdd, craving for opioids, and rates of relapse to opioid use. the investigators will also examine whether rtms can engage gaba mediated inhibition using combined transcranial magnetic stimulation and electroencephalography (tms-eeg) will be assessed before and after intervention. clinical outcomes measured before, during, at end of treatment, and 4-weeks post treatment.

Eligibility criteria:
inclusion criteria: 1. capable of providing informed consent and research procedures according to the brain stimulation attending psychiatrist 2. between the ages of 18-60 years 3. mini-international neuropsychiatric interview (mini) confirmed diagnosis of opioid dependence and mdd. 4. on a stable treatment regimen without any change in opioid agonist or antidepressant medications or dosages in the last 30 days. participants will be asked not to change their medication regimen for the duration of the study. 5. baseline score of \>/=4 on the scale for suicidal ideation (ssi). exclusion criteria: 1. currently pregnant or intending to be pregnant during the duration of the study 2. bipolar disorder, any psychotic disorder or current psychotic symptoms 3. previous rtms treatment 4. known active seizure disorder, significant head injury with an imaging verified lesion 5. unstable medical illness 6. presence of cardiac pacemaker, intracranial implant, or metal in the cranium 7. participants taking \> 2 mg lorazepam (or a benzodiazepine at an equivalent dose) or taking any anticonvulsant medication during treatment.

Keywords: suicidality rtms
open label natalizumab safety extension study for subjects with crohn's disease

Conditions: Crohn's Disease

Summary: the primary objective of this study is to evaluate the long-term tolerability and safety of natalizumab when administered a dose of 300 mg intravenously (iv) to subjects with crohn's disease who have previously participated in studies cd251, cd301, cd303, cd306, or cd307.


Eligibility criteria:
* male and female subjects 18 years and older with crohn's disease who have participated in studies cd251, cd301, cd303, cd306, or cd307 per protocol