cyrilzakka/clinical-trials huggingface dataset:
Piedmont Aging, Cognition & Exercise Study-2

The purpose of this research study is to examine the effects of high and low intensity exercise for those with mild memory loss and pre-diabetes. The investigators will also examine the effects of this exercise on certain proteins and hormones in body fluids, and on brain structure and function using magnetic resonance imaging (MRI). Recent studies indicate that exercise improves memory and thinking abilities for adults with mild memory loss OR pre-diabetes. This study examines the effects of exercise on people with mild memory loss AND pre-diabetes.


Eligibility Criteria:
Inclusion Criteria:

* 50 years or older
* Mild memory concerns
* In good health
* Not taking diabetes medications
* Not currently exercising

Exclusion Criteria:

* Significant neurologic disease that might affect cognition, such as AD, stroke, Parkinson's disease, multiple sclerosis, or severe head injury with loss of consciousness \> 30 min or with permanent neurologic sequelae;
* Significant medical illness or organ failure, such as:
* Liver disease: history of hepatitis or hepatic failure
* Significant elevations in liver function tests: lab values more than 2.5 times the upper limit of normal
* Kidney disease known history of kidney failure.
* Uncontrolled hypertension
* Cardiovascular disease, defined as: any acute cardiovascular abnormality, such as new or unstable angina, uncontrolled irregular heart beat (treated a-fib and occasional PVC's are OK) or symptomatic heart failure, acute shortness of breath for any reason, or clinically significant edema, is an exclusion. History in the last year of myocardial infarction, angina, coronary artery angioplasty, bypass grafting, pacemaker insertion, STENT placement, postural hypotension, transient ischemic attack, or carotid artery surgery.
* Chronic lung disease, such as: COPD/emphysema
* Hemoglobin A1c levels that fall outside the range of 5.7-6.4%; If 2-h OGTT glucose values 220 mg/dL and hemoglobin A1c levels meet inclusion criteria (5.7-6.4%), then PCP written indication that no pharmacologic intervention for type 2 diabetes is needed at present will be required for continued study participation.
* Current use of anti-psychotic, anti-convulsant, anxiolytic, or sedative medication;
* Current use of any cognition-enhancing medication, including experimental medications within the past 60 days;
* Current or previous use of hypoglycemic agents or insulin (except during pregnacy); diabetics previously on oral agents but have been off of them for \> 1 year are ok pending PI and study physician approval.
* Musculoskeletal impairment sufficient to interfere with study participation
Pentoxifylline as an Adjunct to Citalopram in Adult Patients With Major Depressive Disorder

The aim of this study is to test if combining the antidepressant Citalopram with Pentoxifylline (PTX), a medicine with anti-inflammatory and phosphodiesterase inhibitory properties, enhanced antidepressant efficacy in adult patients with major depressive disorder (MDD) when compared to Citalopram alone.

According to mounting evidence, inflammation and phosphodiesterase (PDE) pathways may play a role in the pathogenesis of psychiatric diseases such as MDD. PTX is a phosphodiesterase inhibitor and has anti-inflammatory and antioxidant effects. Therefore, it has been hypothesized that MDD patients taking combined administration of the Citalopram, a Selective Serotonin Reuptake Inhibitor (SSRI), and PTX would show a higher improvement in depression symptoms. The relationship between the Hamilton Depression Rating Scale-17 items (Ham-D-17) score and various biological markers and their potential role in the therapeutic outcome of MDD will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Provide written, voluntary informed consent prior to study enrollment.
* Male or female between the ages of 21 to 65.
* Patient must be diagnosed with a moderate to a severe depressive episode, as determined by the MADRS score \>21.
* Prior to taking part in the trial, all patients were requested to abstain from all psychotropic and anti-inflammatory medications for at least four weeks.

Exclusion Criteria:

* Current psychotic symptoms or perceptual problems of any kind, at the discretion of the investigator
* The presence of a contraindication to PTX, such as a drug allergy or xanthine derivative allergy
* The presence of cardiovascular diseases, including high blood pressure, a recent myocardial infarction, cardiac arrhythmia, coronary artery disease, or a coagulation disorder
* Renal impairment, defined as creatinine clearance less than 80ml/min
* Patients who have previously received electroconvulsive therapy (ECT)
* Patients who have inflammatory disorders
* Patients with a concurrent active medical condition
* Patients with a history of seizures
* Patients who are pregnant or nursing females.
* Patients with bipolar I or bipolar II disorder
* Patients with personality disorders
* Patients with eating disorders
* Patients with substance dependence or abuse
Dietary Nitrate on Blood Pressure and Cardiovascular Disease Risk Factors

The project aims to determine the effect of a high-nitrate dietary intervention on blood pressure and markers of vascular function compared to a low-nitrate intervention in people with elevated blood pressure. Half of the participants will receive the high-nitrate dehydrated vegetable intervention, while the other half will receive the low-nitrate dehydrated vegetable intervention.This project will advance the current hypothesis on the therapeutic link between dietary nitrate and high blood pressure, and potentially derive impactful recommendations for individuals at risk of hypertension.

Diets rich in fruits and in particular, vegetables, reduce blood pressure (BP) and the risk of cardiovascular events. Increasingly, attention is being given to high-nitrate containing vegetables, with emerging evidence that it might represent a source of vasoactive nitric oxide. Clinical data to date uniformly suggest an acute vasoprotective role of dietary nitrate administration and a BP-lowering effect. Whether the vascular effects extend to long-term intake and in individuals with elevated blood pressure is not well known. The investigators hypothesize that consumption of a dietary intervention high in nitrate from vegetable sources will have a greater effect on BP and related vascular parameters than a similar intervention that is low in dietary nitrates.

Eligibility Criteria:
Inclusion Criteria:

* BMI 18.5-35 kg/m2
* Seated systolic blood pressure ≥130 and \<160 mmHg

Exclusion Criteria:

* current use of antihypertensive agents
* history of major cardiovascular events in the last 1 year (stroke or myocardial infarction)
* stage II hypertension as per JNC7 criteria (systolic BP/ diastolic BP ≥160/100 mmHg) - angina pectoris
* gastrointestinal (i.e. inflammatory bowel disease, celiac), liver or kidney disease
* cardiac condition that compromises normal function (e.g. mitral valve disease, heart failure)
* serum triglyceride \>4.5mmol/L
* major disability or disorder requiring continuous medical attention
* planned initiation in antihypertensive therapy
* herb or supplement use that may affect primary outcome
* consuming \>3 servings of vegetables/day (based on semi-quantitative food frequency questionnaire)
* alcohol use \>2 drinks/day
* chronic or prescribed use of medications including prescription NSAIDs, antacids, warfarin, medications affecting NO synthesis (ie. sildenafil, organic nitrates, etc)
* use of antibiotics within 3-months of the study start
* participants should also be willing to refrain from using mouthwash (ie chlorhexidine) for the duration of their participation in the study
Efficacy of Levodopa/Carbidopa/Entacapone vs Levodopa/Carbidopa in Parkinson's Disease Patients With Early Wearing-off

The study evaluated the efficacy of levodopa/carbidopa/entacapone vs levodopa/carbidopa in patients with Parkinson's disease and early wearing-off with levodopa


Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients ages ≥ 30 and ≤ 80 years old.
2. A clinical diagnosis of idiopathic Parkinson's disease.
3. Taking a stable dose of levodopa/carbidopa (≥ 300 and ≤ 600mg) for a period of at least 1 month prior to study entry.
4. Must be using any of the following levodopa/carbidopa standard formulation levodopa/carbidopa 100/25mg dose in any intake of the day.

   * 1 full tablet, and/or
   * 1½ tablets The patient can also be using, for a period of at least 1 month prior to study entry, 1 tablet of the controlled release formulation of levodopa/carbidopa 100/25 mg (marketed in Spain as Sinemet Plus retard) or 1 tablet the controlled release formulation of levodopa/carbidopa 200/50 mg (marketed in Spain as Sinemet retard) in each intake, at different doses.
5. Must have early end-of-dose wearing-off defined by \>= 2 or \<=7 positive responses to the QUICK questionnaire.
6. Must have a minimum UPDRS part II (ADL) score of 9.
7. Patients without dyskinesia or with mild dyskinesia.
8. Female patients must be either post-menopausal or using one or more acceptable methods of contraception.
9. Must be capable of satisfying the requirements of the protocol and must be willing and able to give informed consent according to legal requirements.

Exclusion Criteria:

1. Previous or current use of entacapone.
2. History, signs, or symptoms suggesting the diagnosis of secondary or atypical parkinsonism.
3. Unstable Parkinson's disease patients.
4. Patients who experience severe dyskinesia.
5. The following levodopa/carbidopa doses and strengths are not permitted:

   * Patients taking ½ tablet of standard formulation levodopa/carbidopa 100/25
   * Patients taking standard formulation levodopa/carbidopa 100/10 or 250/25
   * Patients taking fewer than 3 or more than 6 daily intakes of standard formulation levodopa/carbidopa 100/25 (fewer than 300mg or more than 600mg of levodopa)
6. Patients with hallucinations or psychiatric diseases related to levodopa or dopamine agonists intake. Patients with major depression.
7. Female patients who are pregnant, trying to become pregnant or nursing (lactating) an infant.
8. Concomitant treatment with MAO-inhibitors (except selegiline up to 10mg/day), rotigotine or neuroleptics, within 60 days prior to the screening visit.
9. Patients with a previous history of Neuroleptic Malignant Syndrome (NMS) and/or non-traumatic rhabdomyolysis.
10. Participated in another trial of an investigational drug/device within the last 30 days prior to study entry.
11. Patients who have a history of poor compliance or are in the Investigator's judgment unlikely to comply with medical regimens or study requirements.
The Dissemination of Consensus Recommendations on Upper Gastrointestinal Bleeding

The purpose of this study is to assess whether adherence to NVUGIB guidelines is improved with implementation of a national, tailored multifaceted intervention. Outcomes include adherence rates to two key endoscopic and pharmacological therapy guidelines together (primary), or adherence to these individually as well as to other recommendations (secondary). Patient outcomes and economic data are also assessed (tertiary).

Clusters are randomized to receive a published algorithm and guidelines (control group), or a multifaceted, tailored educational intervention (see details in protocol - intervention group). The charts of treated patients with non variceal upper GI bleeding are reviewed and adherence to selected guidelines recorded.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or over.
* Treated during the study duration
* Primary or secondary discharge diagnoses of NVUGIB (per charted ICD-10 code). Additional confirmation of NVUGIB using endoscopic findings or patient symptoms done as previous.

Exclusion Criteria:

* Patients initially assessed at another institution for the present episode of NVUGIB and subsequently transferred to the participating site with unavailable initial data.
* Endoscopy noted no gastro-duodenal ulcer bleeding, to ensure patient homogeneity.
Trial Comparing One-stage With Two-stage Basilic Vein Transposition

Arteriovenous fistulas (AVFs) are made by joining a vein to an artery in order to get the vein dilated with sufficient blood flow in order to puncture the vein and clear the blood from wastes, in patients whose kidneys are destroyed and cannot provide this function. The success rate of this procedure varies between 50-80% and depends mainly on the size of the vein, with success being higher with larger veins. One of the veins used for an AVF is the basilic vein, located at the upper arm. This vein is however deeply located and necessitates movement (transposition) during surgery to a less deep and lateral path before it is joined to the artery, in order to be used. A single study has shown that surgery performed in two parts (one to enlarge the vein and the second one to relocate the enlarged vein under the wound, not in a new path) is more successful than doing the procedure altogether.

The aim of this study is to confirm the findings of the single study mentioned above (one versus two stages of basilic vein AVF), with the difference that the vein will be relocated outside the main wound, a method that is widely accepted as being better.

Arteriovenous fistulas (AVFs) are made by anastomosing a vein to an artery in order to get the vein dilated with sufficient blood flow in order to puncture the vein and perform hemodialysis in patients with renal failure. The success rate of this procedure varies between 50-80% and depends mainly on the size of the vein, with success being higher with larger veins. One of the veins used for an AVF is the basilic vein, located at the upper arm. This vein is however deeply located and necessitates transposition during surgery to a less deep and lateral subcutaneous plane before the anastomosis with the artery, in order to be used. A single study has shown that surgery performed in two stages (one to enlarge the vein and the second one to relocate the enlarged vein under the wound, not in a new path) is more successful than doing the procedure in one stage.

The aim of this study is to confirm the findings of the single study mentioned above (one versus two stages of basilic vein AVF), with the difference that the basilic vein will be relocated outside the main wound, a method that is widely accepted as being better.

Eligibility Criteria:
Inclusion Criteria:

* chronic renal failure on hemodialysis
* chronic renal failure with anticipated hemodialysis

Exclusion Criteria:

* Patient unwillingness, not consenting
* Cephalic vein options
* Basilic vein less than 2.5 mm
* Basilic vein with intrinsic lesions, unsuitable for use
A Prospective Radiostereometric Analysis and Clinical Evaluation of the Zimmer® Continuum® Acetabular Cup With Vitamin E Stabilized Polyethylene

The purpose of this study is to use Radiostereometric Analysis (RSA) and clinical outcome measures to evaluate early, post-operative implant stability, post-operative implant fixation, clinical performance, and in-vivo wear of the Zimmer® Continuum® Cup with vitamin E stabilized polyethylene.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic osteoarthritis of the hip indicating surgical intervention
* Scheduled to undergo an uncemented total hip arthroplasty (THA)
* Patients between the ages of 18 and 65, inclusive
* Ability to give informed consent
* Patients will be available for follow-up for a minimum of 2 years after surgery

Exclusion Criteria:

* Patients less than 18 years of age, or older than 65 years of age.
* Post-traumatic arthritis in the affected hip
* Rheumatoid arthritis in the affected hip
* Hip dysplasia in the affected hip
* Prior arthroplasty of the affected hip
* Active or prior infection of the affected hip
* Morbid obesity (BMI \> 35)
* Medical condition precluding major surgery
* Severe osteoporosis or osteopenia
* Neuromuscular impairment
* Patients with known allergy to metals
* Pregnancy
* Patients with compromised kidney function
* Patient is immuno-suppressed
* Patients that require a femoral head less than 32 mm or greater than 40mm.
Nutritional Status and Medication Treatment in Home-dwelling Older Adults

The project "Nutrition and Medication management in home-dwelling older adults" consist of two separate studies witch are described in the same study protocol. This is the first study in this Project. The second study is described separately; Identification: 2017/12883-2

Malnutrition is common in older adults. The causes are many and include adverse drug effects. Loss of appetite, nausea, or dry mouth are adverse drug effects, which may contribute to malnutrition. Knowledge about possible relations between drug treatment and nutritional status is scarce.

The objectives of the project is to describe nutritional status, drug treatment and the prevalence of potentially inappropriate medication in home-dwelling elderly receiving home care service in two Norwegian municipalities.

Recruitment by a the home nurse service. An informed content from the participant (or a close relative for those not able to give an informed consent) is required. A nurse will visit the participants and ask for information about six items concerning: food intake, weight loss, mobility, psychological stress, neuropsychological problems. The height and weight will be measured. A photo of the medicine prescription card will be taken. The investigators have created an online solution for collection of these sensitive data, including photos of the medication prescription card.

The data will automatically be stored in a secure database at the University of Oslo (TSD), for further analyses.

Eligibility Criteria:
Inclusion Criteria:

* Home-dwelling
* Be admitted to home-nursing service, every second week or more often.
* Age 70 or older
* Medication administrated by home nursing service.
* Informed consent by patient or close relative (next of kin)

Exclusion Criteria:

• Patient or next of kin denies inclusion
Bleeding Events After Triple Antithrombotic Therapy Initiation.

The optimal antithrombotic therapy for patients requiring anticoagulation after coronary stenting is unknown. Double platelets suppressive agents combined with oral anticoagulation (triple antithrombotic therapy) remains the Gold standard.

Our study aims at studying bleeding events occurring until 6 months after the initiation of triple antithrombotic therapy.


Eligibility Criteria:
Inclusion Criteria:

* patients requiring triple antithrombotic therapy, including double antiplatelets agents and oral anticoagulation

Exclusion Criteria:

* history of bleeding
* patients already under triple antithrombotic therapy
* patients under vitamin K antagonists
Bone Forming at Prosthetic Surfaces. Fingerprint2

What is the intensity of F-PET uptake in healthy and osteo arthritic femur and acetabulum, compared to the uptake adjacent to four analyzed endoprosthetic components 1½ and 6 months after surgery?

A clinical study of 26 patients, age 50-69 years, healthy unless osteoarthritis in one hip, randomized in four groups plus a reference group of same 26 patient´s contralateral healthy hip.

Intervention will be surgery with a total hip arthroplasty. The studied endoprosthetic components are: Cemented Lubinus SP II stem with a ceramic 32 mm head, a cemented Lubinus cross linked cup (Waldemar Link, Hamburg, Germany). Palacose cement with gentamycin, applied with 3:rd generation cementation technique will be used for those cemented implants.

Uncemented HA-coated Corail stem with a ceramic 32 mm head (DePuy, Johnson \& Johnson, USA), a fibrous metal Regenerex RingLoc cup (Biomet, Warsaw, Il, USA) All cups will have cross linked Ultra-high-molecular-weight polyethylene (UHWMP).

Clinical score, radiography and PET uptake of Fluoride tracer (SUV) adjacent to the prosthetic surfaces will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed to have unilateral hip osteo arthritis (Charnley group A) aimed for THA at the orthopedic clinic Gävle hospital.

Exclusion Criteria:

* Systemic disease or medication affecting the skeleton
Internet Treatment for Social Phobia in Romania

The main aim of this study is to investigate the effectiveness of an Internet-delivered intervention for social phobia by comparing it to a waitlist control group. The second aim of the study is to track the potential changes in participants' thinking patterns. Because this is among the first guided Internet-delivered interventions conducted in Romania, the treatment credibility will also be investigated. Finally, the predictive power of anxiety sensitivity for both SAD symptoms and the treatment effectiveness will be investigated.

The primary aim of this study is to investigate the effectiveness of an internet intervention for social phobia (i.e., the iSOFIE) by comparing it to a waitlist control group. iSOFIE was derived from a previously tested program (Furmark, Holmström, Sparthan, Carlbring, \& Andersson, 2006) and has been significantly shortened while retaining the most important elements. The second aim of the study is to track the potential changes in participants' thinking patterns. While this intervention is primarily based on the cognitive-behavioral model of SAD (Clark and Wells, 1995), and no specific Rational Emotive Behavior Therapy (REBT, Ellis \& Dryden, 1997) will be implemented, it is hypothesized that the cognitive restructuring and exposure exercises will make participants less prone to irrational thinking (as measured by the Attitude and Belief Scale-II (ABS-II, DiGiuseppe, Leaf, Exner, \& Robin, 1988). To our knowledge, no study has investigated whether an iCBT program for SAD has the potential to alter participants' irrational thinking patterns. Moreover, because this is among the first guided Internet-delivered interventions conducted in Romania, the treatment credibility of the program will be investigated. Finally, the predictive power of anxiety sensitivity for both SAD symptoms and the treatment effectiveness will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* over 18 years
* social anxiety disorder is the primary diagnostic (according to the DSM-IV)
* access to an Internet connected computer
* be fluent in Romanian language

Exclusion Criteria:

* suicidal ideation
* ongoing psychological treatment for social anxiety disorder
* recent change in psychiatric medication (i.e., during the last 6 weeks)
* psychoses or borderline personality disorder