cyrilzakka/clinical-trials huggingface dataset:
Predicting Physical Activity Change: an Epidemiologic Study

To conduct a two-year follow up of participants in a cross-sectional study of physical activity determinants. Predictors of change in vigorous exercise habits and recreational walking habits were identified as were determinants of change in the proportion of the sample who initiated, maintained, or discontinued exercise.

BACKGROUND:

In 1988 when the study began, epidemiological studies had shown the health benefits of physical activity and that prevalence of physical activity was well below recommended levels. Exercise-promotion interventions were typically ineffective, and lack of knowledge of exercise determinants inhibited the design of effective interventions.

DESIGN NARRATIVE:

Data from the San Diego Health and Exercise Baseline survey conducted in 1986 were used to contact participants for the follow-up. The difference in reported activity level from time 1 to time 2 served as an estimate of change in activity. The follow-up survey elicited a two-year history of vigorous exercise and moderate-intensity exercise, both of which have substantial health benefits, as well as different determinants. Potential predictors were assessed at baseline and included demographic variables and indices based on social learning theory. Multiple regression analyses determine the combined and independent relationships of such variables as self-efficacy, social support, perceived barriers and benefits and environmental factors on both types of physical activity change. A second analysis separated subjects into the baseline physical activity groups of low, intermediate, and high activity and examined prediction of change versus no-change in each category.

Eligibility Criteria:
Inclusion

1. Healthy Adults 18-60

   Exclusion
2. Cardiovascular Disease
3. Heart Disease
Dietary Intake of Alpha-linolenic Acid in Elderly

The purpose of this study is to evaluate the antiatherogenic and anti-inflammatory potential of an adequate intake of alpha-linolenic acid in elderly.

There is growing evidence that diets high in long chain n-3 polyunsaturated fatty acids (PUFA) decrease the risk of fatal ischemic heart disease.Both epidemiologic studies and clinical trials demonstrate substantial cardioprotective effects of alpha linolenic acid (ALA) from vegetable oils.However, little is known about the relation of the dietary intake of ALA with ischemic heart disease among older adults.In this study, elderly volunteers will be asked to ingest a supplement of a vegetable oil providing 1g of ALA, or an equivalent amount of linoleic acid as sunflower oil, for a diet period of 6 weeks.Serum samples will be collected before the dietary intervention and 6 weeks later.Plasma biomarkers of inflammatory, lipid cardiovascular risk factors and serum and red cell membrane fatty acid composition will be determined on all samples.

Eligibility Criteria:
Inclusion Criteria:

* Elderly patients over 65 years old exhibiting clinical indices of cardiovascular disease
* Male or female
* Subjects who were hospitalized in the Geriatric Unit of the Emile Roux Hospital (AP-HP)
* MMSE (Mini Mental State Examination)score \> or = 15
* Supervision available for study medication
* Able to ingest oral diet

Exclusion Criteria:

* Patients unable to understand the objectives of the dietary intervention
* Patients in paliative care
* Patients receiving supplement diets
Refining a Biobehavioral Intervention to Enhance Recovery Following Hematopoietic Stem Cell Transplantation

The goal of this project is to refine and evaluate the feasibility of a brief, behavioral intervention to improve the recovery following hematopoietic stem cell transplantation (HSCT). Cancer patients who were treated with HSCT will learn behavioral techniques to improve sleep and increase daytime activity with the goal of alleviating insomnia, fatigue, and depression after HSCT. If the intervention is feasible and acceptable to patients, a future study will test the effects in a larger trial, with the long-term goal of improving the care and quality of life of cancer survivors recovering from HSCT.

Details of the assessment strategy:

Patient-reported outcomes:

Participants will complete self-report measures prior to HSCT and 9 (mid-intervention) and 18 weeks (post-intervention) post-HSCT. The sleep disturbance, fatigue, and depression modules of the NIH Patient Reported Outcomes Measurement Information System (PROMIS) will be the primary outcomes. The investigators will compare performance with more established instruments the investigation team has previously used: Insomnia Severity Index (ISI), Fatigue Symptom Inventory (FSI), and the Inventory of Depression and Anxiety Symptoms (IDAS) depression subscale.

Actigraphy:

The Actiwatch-2 (Philips Respironics), a wrist-worn actigraphy device, will be used to objectively quantify circadian rest-activity patterns over a continuous 7-day period using 1-minute sampling epochs at three time points: prior to HSCT and 9 (mid-intervention) and 18 weeks (post-intervention) post-HSCT. The following indices will be calculated: mesor (mean activity level), amplitude (rhythm height), acrophase (time of day the rhythm peaks), and R-squared (robustness of the rhythm). Participants will complete a concurrent nightly sleep log, and traditional sleep parameters will be calculated from both the logs and actigraphy, including total sleep time (TST), sleep onset latency (SOL), wake time after sleep onset (WASO), and sleep efficiency (SE). For daytime activity, calibration thresholds will be used to aggregate activity data into steps and minutes spent in sedentary, light, moderate, and vigorous activity

Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years of age or older undergoing hematopoietic stem cell transplantation (HSCT) at the University of Wisconsin Carbone Cancer Center (UWCCC)
* Autologous transplant recipients with multiple myeloma or lymphoma (both Hodgkin's and Non-Hodgkin's types) receiving standard conditioning regimens
* Allogeneic transplant recipients undergoing fully ablative transplants
* Participants who develop treatment complications or disease recurrence after being enrolled in the study may continue to participate if they are able to do so

Exclusion Criteria:

* Autologous transplant recipients receiving non-standard regimens
* Autologous transplant recipients with diagnoses other than multiple myeloma or lymphoma
* Allogeneic transplant recipients receiving reduced intensity regimens
Habit Formation for Diabetes Self-Management

The purpose of the study is to determine the feasibility of interventions which focus on building habits as a method of improving diabetes self-management behaviors for individuals with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* 19 years old
* read and write in the English language
* have technology capability for virtual or telephone sessions
* are reachable by phone or text messaging
* have a diagnosis of T2DM
* were willing and able to participate in all study-related activities, and
* were not currently involved in other diabetes-related education and behavioral interventions.

Exclusion Criteria:

* younger than 19 years old
* unable to read and write in the English language
* did not have technology capability for virtual or telephone sessions
* were not reachable by phone or text messaging
* were unwilling or unable to participate in all study-related activities, and/or
* were currently receiving or involved in other diabetes-related education and behavioral interventions.
Urinary Biomarkers for AKI Diagnosis in Patients With SARS-CoV-2 (COVID-19)

Among patients with SARS-CoV-2 pneumonia, approximately 20% have an acute kidney injury (AKI) and 5% require renal replacement therapy. Occurrence of AKI in patients with COVID-19 is associated with increased morbidity and mortality. Early detection of patients at risk of AKI would allow to prevent onset or worsening of AKI. The aim of this study is to determine if urine biomarkers of renal tubular damage such as TIMP-2 and IGFBP7 could early identify patients with SARS-CoV-2 pneumonia at risk of developing AKI.


Eligibility Criteria:
Inclusion criteria:

* Age ≥ 18 years
* COVID-19 confirmed by positive SARS-CoV-2 PCR
* at least one urine sample

Exclusion criteria:

* Persons under protection
* Paritcipation rejections
Effect of Postprandial Hyperinsulinaemic Hypoglycaemia on Driving Performance.

The primary objective of this study is to assess the effect of the natural course of postprandial hypoglycemia vs. a postprandial euglycaemic condition on driving performance in individuals with confirmed postprandial hyperinsulinaemic hypoglycaemia after gastric-bypass surgery.

Despite the increasing prevalence of postprandial hyperinsulinaemic hypoglycaemia (PHH), clinical implications are still unclear. Anecdotal evidence from patients with PHH suggest a high burden for these patients due to the recurrent hypoglycaemias with possibly debilitating consequences. It is well established, that even mild hypoglycaemia (plasma glucose of 3.4mmol/l) in diabetic and non-diabetic significantly impairs cognitive-motor functioning. Of note, some of the cognitive aspects remain impaired for up to 75min, even when the hypoglycaemia is corrected. In addition to the hypoglycaemic blood glucose levels per se, the dynamics of the hypoglycaemia occurrence appears to play a role. It was shown in individuals with type 1 diabetes, that cognitive functions are affected more during a fast-fall than slow fall hypoglycaemia in the postprandial state.

Driving is a frequent daily activity which integrates various mental function including visual and auditory processing, motor skills, reasoning and problem solving. Due to the potentially dangerous consequences, avoidance of hypoglycaemia-induced driving mishaps is of uttermost importance. Several studies have evaluated the impact of induced, controlled hypoglycaemia in individuals with type 1 diabetes on driving performance using driving simulators but data in PHH patients are currently lacking. Assessing the potential impact of the natural course of postprandial hypoglycaemia on driving performance in PHH patients will contribute to a better understanding of the consequences and relevance of this problem. The investigator will test the hypothesis whether driving performance during the postprandial glucose dynamics is impaired in patients with confirmed PHH.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years
* Roux-en-Y gastric bypass ≥1 year ago
* PHH defined as postprandial plasma or sensor glucose\<3.0mmol/l according to the International Hypoglycaemia Study Group (1) and exclusion of other causes of hypoglycaemia
* Possession of a valid Swiss driver's license. Passed driver's examination at least 3 years before study inclusion. Active driving in the last 6 months before the study.

Exclusion Criteria:

* Clinically relevant weight changes (≥5%) within the past 3 months
* Incapacity to give informant consent
* Historical or current diabetes based on HbA1c ≥6.5% without glucose-lowering treatment
* Haemoglobin level below 11 g/dl
* Ongoing treatment with glucose-lowering drugs, anorectic drugs, steroids or any medications known to affect gastric motility
* Active heart, lung, liver, gastrointestinal, renal or neurological disease
* Inability to follow study procedures
* Pregnancy or breast-feeding
The Neuroprotection of Sevoflurane Preconditioning on Intracranial Aneurysm Surgery

The current study is designed to clarify the neuroprotective effect of sevoflurane preconditioning on the patients underwent intracranial aneurysm surgery.

The current study is designed to clarify the neuroprotective effect of sevoflurane preconditioning on the patients underwent intracranial aneurysm surgery. The patients with cerebral aneurysm will be recruited in current study. The sevoflurane preconditioning will be performed before the surgical procedure. The neurological injury biomarkers, such as S-100b and NSE will be detected. The neurological function and recovery will be assessed after the surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patient under intracranial aneurysm surgery.

Exclusion Criteria:

* Patients who refused to participate or who had a history of chemotherapy/convulsions two weeks prior to admission, stroke/cardiopulmonary resuscitation/head trauma three months prior to admission, Alzheimer's disease, amyotrophic lateral sclerosis, and prior melanoma were excluded.
The Pathogenesis of Inflammatory Synovitis: A Study of Early Arthritis

This study will evaluate patients with inflammatory forms of arthritis within the first year of onset. The study will attempt to clarify factors that may predict disease course such as evolution into rheumatoid arthritis (RA) or other chronic inflammatory arthropathies. Synovial biopsies and synovial fluid will be obtained to search for microbial agents and other initiating and modulating factors that may be most readily distinguished early in the disease and to determine the stage of disease at which certain immunologic and hormonal changes become evident. The study will also search for genetic and other features that may be associated with specific forms of inflammatory arthropathies that might predict the subsequent clinical disease course or response to different agents used in treatment of RA, Reiter's syndrome and other types of chronic inflammatory arthropathies.

This study will evaluate patients with inflammatory forms of arthritis within the first year of onset. The study will attempt to clarify factors that may predict disease course such as evolution into rheumatoid arthritis (RA) or other chronic inflammatory arthropathies. Synovial biopsies and synovial fluid will be obtained to search for microbial agents and other initiating and modulating factors that may be most readily distinguished early in the disease and to determine the stage of disease at which certain immunologic and hormonal changes become evident. The study will also search for genetic and other features that may be associated with specific forms of inflammatory arthropathies that might predict the subsequent clinical disease course or response to different agents used in treatment of RA, Reiter's syndrome and other types of chronic inflammatory arthropathies.

Eligibility Criteria:
Patients to be studied will be required to have an inflammatory arthritis of less than one year's duration.

Patients must be greater than 18 years of age.

Pregnant patients may be entered into the study, but they will not undergo percutaneous needle biopsy or joint radiographs.

No patients with known bacterial septic arthritis, crystal-induced, or degenerative arthritis.

Synovial biopsies will not be performed if patients have platelet counts less than 70,000/mm(3), other bleeding diathesis in the skin over the joint or sepsis.

Joint MRI: Patient must currently be evaluated at the NIH through protocol 94-AR-0194 or 98-AR-0150.

Joint MRI: Patient must have at least one clinically active arthritic joint that is under consideration for percutaneous needle synovial biopsy.

Joint MRI: Patients must not have the following: cardiac pacemakers, auto defibrillators, neural stimulators, aneurysm clips, metallic prostheses, cochlear (ear) implants, any implanted devices (pumps, infusion devices, etc.), metal fragments in the eye, or shrapnel injuries.

Joint MRI: Patients must not exceed the size limitations of the MRI scanner.

Joint MRI: Must not suffer from claustrophobia.

Joint MRI: Must not have had a previous anaphylactoid reaction to gadolinium-based contrast material.

Joint MRI: Must not be pregnant.
Inpatient Link to Addiction Recovery

The objective of this proposal is to link inpatients to a certified peer support specialist through FAVOR-Greenville and determine the effectiveness of recovery coaching on patient outcomes.This study will evaluate the impact of initiating peer recovery coaching during SUD patients' hospitalization on engagement in recovery services, addiction severity, and quality of life compared to the current standard of care.

The United States is in the midst of a drug overdose crisis: the rate of substance use, overdose, and substance abuse-related economic costs is rapidly increasing. Despite the prevalence of Substance Abuse Disorder (SUD), only 10% of SUD patients receive treatment. The initial link into care is often one of the hardest barriers to overcome due to wait times, complex systems to navigate, and fluctuating motivation. Hospitalization is often a time when patients are more receptive to SUD treatment. One potential effective treatment approach is peer recovery support services. Currently at Greenville Memorial Hospital, there is no direct link between hospitalization and outpatient care for patients with SUD, making it difficult to start or continue the recovery process. Thus, the goal of this study is to evaluate the impact of the initiation of peer recovery services during hospitalization on addiction severity and quality of life. By establishing a successful inpatient link to recovery treatment, this study may lead to the development of an effective method of care that can readily be implemented into the healthcare system.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* English speaking;
* Identified by healthcare provider as having Substance Use Disorder
* Recent substance use
* Currently admitted to the Medical Teaching Services, general medicine hospitalist services, or Infectious Disease Consult service at Greenville Memorial Hospital

Exclusion Criteria:

* Are unable to provide informed consent (intubation, confusion, etc.) during hospitalization
* Are admitted for marijuana use only
* Are pregnant
Substrate Metabolism and Insulin Sensitivity in Acromegalic Patients Before and After Treatment

The purpose of this study is to investigate the effects of chronic elevated growth hormone on metabolism and insulin sensitivity by studying acromegalic patients before and after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Written consent
* Age between 18 and 70
* Recently diagnosed with acromegaly

Exclusion Criteria:

* NYHA 3
* Uncontrolled hypertension
* Known cerebrovascular disease
* Proliferative retinopatia
Evaluating Preventive Therapy With Oint Threolone, Synthomycine or Aqua Cream, for EGFR'I Induced Acneiform Rash

The investigators hypothesized that topical anti-inflammatory treatment could counteract the inflammatory reaction induced by EGFR'Is.

The investigators hypothesized that topical anti-inflammatory treatment could counteract the inflammatory reaction induced by EGFR'Is.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are planed to initiate treatment with either cetuximab , erlotinib, gefitinib or panitumumab.

Exclusion Criteria:

* Patients who received any facial topical treatment / systemic antibiotics or any anti-inflammatory drug during the 2 weeks prior to study initiation.
* Known hypersensitivity to ointment Synthomycine or to Threolone.
* Patients presented with cutaneous rash during the 2 weeks prior to study initiation
Goal-directed vs Preemptive Tranexamic Acid Administration in Non-cardiac Surgery

The present study is a multi-center randomized prospective non-inferiority trial. The study's primary objective is to compare the coagulation profile upon using two different TXA administration strategies: empirical TXA administration vs. viscoelastic test-based goal-directed TXA administration in high-risk non-cardiac surgery. The secondary objectives include comparing the amount of bleeding, incidents of hyper-fibrinolysis, thromboembolic complications, and postoperative seizures. Researchers assumed that goal-directed tranexamic acid (TXA) administration using viscoelastic field tests would not be inferior to the empirical TXA administration strategy in reducing postoperative bleeding and hyper-fibrinolysis. It also would be beneficial in lowering TXA-induced thromboembolic complications and seizures.

The present study is a multi-center randomized prospective placebo-controlled non-inferiority trial. This study's primary objective is to compare the coagulation profile upon using two different TXA administration strategies: empirical TXA administration vs. viscoelastic test-based goal-directed TXA administration in non-cardiac surgery. The secondary objectives include determining the inter-group differences in hyper-fibrinolysis, during postoperative 2bleeding, thromboembolic complications, and postoperative seizures. Researchers hypothesized that goal-directed TXA administration using viscoelastic field tests would not be inferior to the empirical TXA administration strategy in reducing postoperative bleeding and hyper-fibrinolysis. Researchers also expect that goal-directed TXA administration would be beneficial in lowering TXA-induced thromboembolic complications and seizure risks.

Eligibility Criteria:
Inclusion Criteria patients undergoing following surgery

* spinal fusion surgery with more than 2 levels
* total hip arthroplasty
* total knee arthroplasty
* open prostatectomy
* hepatectomy

Exclusion Criteria:

* pregnancy
* refusal of allogenic blood transfusion
* taking thrombin
* history of thromboembolic and familial hypercoagulability disease
* recent history of myocardial infarction or ischemic cerebral infarction (within 90 days)
* hypersensitive to TXA
* histroy of convulsion or epilepsy
* taking hemodialysis
* history of Heparin-induced thrombocytopenia
Safety and Efficacy Evaluation of <Dovprela Tablets 200 mg> by Post-marketing Surveillance

Dovprela Tablets (Pretomanid) is the only treatment approved for the treatment of drug-resistant tuberculosis on a wider scale.

This non-interventional post-marketing surveillance (PMS) study is one of the obligations that must be followed under the Ministry of Food and Drug Safety (MFDS). In accordance with the Pharmaceutical Affairs Act and the re-examination criteria for new drugs, etc. notified by the MFDS, this study will be conducted with the purpose to collect and review required information on the safety and efficacy of drugs requiring re-examination for appropriate use. Safety and efficacy information will be provided for a minimum of 100 subjects who receive treatment in general clinical settings for a period of 4 years following approval.

This survey is an open, non-comparative, non-interventional, prospective, multicenter study conducted by certified physicians (i.e., the investigator) at a Korean medical institution.


Eligibility Criteria:
Inclusion Criteria:

* To be eligible for participation in this study, subjects must meet the following inclusion criteria:

  1. Patients who have been administered Dovprela Tablets according to the current local labelling after the study is initiated at the study institution
  2. Subjects who have consented to participate in this study by signing the data privacy statement

Exclusion Criteria:

* Patients falling under any of the following criteria are not included in the study:

  1. Cases with duplicated studies (In the event of duplicated cases, the case that has been collected first will be recognized.)
  2. Patients with hypersensitivity to active substance (Pretomanid) or components. The list of components is as follows:

     \*Components: Lactose monohydrate, microcrystalline cellulose, povidone, sodium starch glycolate, magnesium stearate, colloidal silicon dioxide, sodium lauryl sulfate
  3. Patients with contraindications to use Bedaquiline and/or Linezolid as Dovprela Tablets are used as a combination treatment with Bedaquiline and Linezolid
  4. Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
  5. Other patients whom the investigator decides not to prescribe under general practice, considering the overall balance of risks and benefits, such as those who are pregnant or breastfeeding

If data of the subjects that have not been used within the scope of permitted items is collected, it shall be analysed as a separate item.