cyrilzakka/clinical-trials huggingface dataset:
Prediction of Systemic Thromboembolism and Bleeding in Atrial Fibrillation Patients With Factor Xa Inhibitor (Apixaban, Rivaroxaban) by Echocardiographic Parameters: Prospective Observational Study (AF-ECHO Study)

Patients taking Factor Xa inhibitors (Apixaban, Rivaroxaban) in atrial fibrillation will be conducted a follow-up investigation on systemic embolism and bleeding events.

This study aims to evaluate 1) the efficacy and safety of Factor Xa inhibitors (Apixaban, Rivaroxaban) in atrial fibrillation patients who meet the inclusion criteria, and 2) the relationship between systemic embolism and bleeding by tracking and analyzing echocardiographic data, with the goal of developing an AF-ECHO NOAC Score to predict these events. Additionally, we aim to create a predictive model for thromboembolic and bleeding events by observing the occurrence and progression of mitral and tricuspid regurgitation due to atrial remodeling and annular dilation in atrial fibrillation.

Eligibility Criteria:
Inclusion Criteria

1. Male and female patients aged 19 years or older with chronic atrial fibrillation, accompanied by at least one of the following conditions:

   ① Heart failure

   ② 2. Myocardial infarction (more than 3 months post-event)

   ③ 3. Angina (if PCI was performed, more than 3 months post-procedure)

   ④ 4. Hypertension

   ⑤ 5. Diabetes mellitus
2. Patients who started taking Factor Xa inhibitors (Apixaban, Rivaroxaban) within the last 12 months and have echocardiographic images taken within 3 months of that time, which are available for analysis.
3. Patients who are starting treatment with Factor Xa inhibitors. (Apixaban, Rivaroxaban)
4. Individuals who have voluntarily provided written consent to participate in this clinical trial.

Exclusion Criteria

1. Patients with creatinine clearance (CCr) less than 15 ml/min.
2. Patients with moderate to severe mitral stenosis.
3. Patients who have undergone mechanical valve replacement
4. Patients with a history of clinically significant alcohol or drug abuse.
5. Patients whom the investigator deems legally or mentally unsuitable for participation in the clinical trial, or those who do not consent to participate in the study.
Uppsala-Dalarna Dementia and Gait Project

UDDGait™ is a multidisciplinary research project with the overreaching goal of providing an aid for early identification of cognitive impairment and risk of dementia development, thereby providing a basis for adequate symptom relieving and health promoting interventions.

A new concept is investigated for this purpose: a "dual-task-test", which implies the combination of a well-established mobility test (Timed Up-and-Go, TUG) with a simultaneous verbal task (i.e. TUG dual-task, TUGdt). This type of test has been judged as a potential aid for early identification of dementia disease. More research is needed to further examine the test's validity, reliability and predictive capacity.

The overall aim is to investigate if TUGdt is useful as an aid for prediction of dementia disease. To ensure the results, the aim is also to evaluate the test's measurement properties and to generate normative reference values of healthy control persons.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing memory assessment at at Uppsala University Hospital, Sweden
* Patients undergoing memory assessment at at Falu Hospital, Sweden
* Cognitively unimpaired individuals with a Mini Mental State Examination (MMSE) score of \> 26

Exclusion Criteria:

* Inability to walk three meters back and forth
* Inability to rise from a sitting position
* Indoor use of a walking aid
* Current or recent hospitalization (within the last 2 weeks)
* Need of an interpreter to communicate in Swedish
Testosterone-induced Muscle Memory and Underlying Mechanisms

The purpose of this project is to investigate underlying mechanisms of testosterone- and resistance training-induced muscle hypertrophy and muscle memory in humans.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* BMI of \<26 and normal ECG and blood pressure

Exclusion Criteria:

* Smoking
* Chronic disease,
* Use of prescription medication
* Pain due to current or previous musculoskeletal injury
* Resistance training more than once per week in the 12 months leading up to the intervention
* Current or previous use of prohibited anabolic substances
A Water Consumption Study of ALKS 5461 in Healthy Volunteers

This study will evaluate the impact of water consumption on the pharmacokinetics of ALKS 5461.


Eligibility Criteria:
Inclusion Criteria:

* Has a body mass index (BMI) of 18.0 - 30.0 kg/m\^2
* Is in good physical health
* Agrees to use an approved method of contraception for the duration of the study
* Additional criteria may apply

Exclusion Criteria:

* Is currently pregnant or breastfeeding
* Has a history of substance abuse disorder
* Has used nicotine within 90 days prior to the study or anticipates a need to use nicotine during the study period
* Has used any prescription or over-the-counter medication, including natural health products or dietary supplements (with the exception of prescription contraceptives or hormonal replacements, acetaminophen, ibuprofen, or multivitamins) within 14 days prior to study start
* Has used opioids within 30 days prior to screening, or has an anticipated need for opioid medication at any point during the study
* Has used alcohol within 72 hours prior to any inpatient period
* Is a heavy caffeine drinker (regularly consuming 5 or more caffeinated beverages per day)
* Has a history of intolerance or hypersensitivity to opioids (buprenorphine) or opioid antagonists (naltrexone, naloxone)
* Additional criteria may apply
Application of Direct Current Transcranial stImulation, Remotely superVised in Chronic fATiguE

It is a one-arm open-label interventional study with transcranial direct current stimulation in an remote home-based setting with the aims to evaluate the feasibility (usability of the device, compliance of patients, usability of the teletherapy), the effectiveness (clinical ratings) and the compatability of this intervention in 20 patients with myalgic encephalomyelitis/chronic fatigue syndrome.


Eligibility Criteria:
Inclusion Criteria:

* ME/CFS diagnosis according to the Canadian Consensus Criteria
* residence near Regensburg and mother language German
* written informed consent
* stable medication if possible

Exclusion Criteria:

* contraindications for transcranial direct current stimulation
* certain neurological conditions as assessed by study physician
* participation in another study
* pregnancy and lactation period
A Comparability Study of the Phase 3 Lot and a Single Commercial Lot of NicVAX in Healthy Adult Smokers

The purpose of this study is to assess the comparability of the phase 3 lot and a single commercial lot of NicVAX in healthy smokers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female smokers, age 18-55, who are currently smoking at least 10 cigarettes per day.

Exclusion Criteria:

* Prior exposure to NicVAX or any other nicotine vaccine.
* History of clinically significant allergic reactions.
* Use of systemic steroids.
* Cancer or cancer treatment within 5 years.
* HIV infection.
* History of drug or alcohol abuse or dependence.
* Required treatment for depression within the past 12 months.
* Body mass index ≥ 30 \[calculated as weight (kg)/height2 (m)\].
* Significant cardiovascular, hepatic, renal, psychiatric and/or respiratory disease.
* Inability to fulfill all visits for approximately 30 weeks.
Dual Antiplatelet Therapy (DAPT) in Patients With Baseline Thrombocytopenia

The use of clopidogrel as part of DAPT will be associated with lower bleeding rates compared to ticagrelor in patients with chronic thrombocytopenia requiring Percutaneous intervention (PCI )with Drug Eluting Stent (DES) or Bare Metal Stint(BMS).

Patients with thrombocytopenia are at an increased risk of both bleeding and ischemic events following PCI; however, there is a paucity of data on how to optimally manage these risks. Data indicates that ticagrelor is associated with reduced ischemic outcomes with an accompanying increased risk of bleed in the broader population. This study will assess P2Y12 agent selection in patients with chronic thrombocytopenia to determine if one better balances risks of ischemic and bleeding events following coronary intervention

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years
* PCI with either DES or BMS during study time period (April 1, 2018 through July 1 2021)
* Thrombocytopenia defined as platelet count \<100 x103 /µL on at least one occasion prior to PCI
* At least one dose of DAPT post-PCI with aspirin and either clopidogrel or ticagrelor

Exclusion Criteria:

* Death within 48 hours post-PCI
* DAPT prior to cardiac catheterization
A Study of LY2835219 in Participants With Cancer

The purpose of this study is to assess how the body handles Abemaciclib when it is given with another drug called clarithromycin. The study doctor will measure the amount of Abemaciclib that is absorbed into the blood stream and the time that it takes to remove Abemaciclib from the body. The safety and tolerability of these drugs will be studied.

Each participant will complete 2 study periods in fixed order. After screening, Period 1 will last approximately 8 days and Period 2 will last approximately 15 days. Participants who complete Period 2 may continue to receive Abemaciclib in 28-day cycles until discontinuation criteria are met.


Eligibility Criteria:
Inclusion Criteria:

* Have histological or cytological evidence of cancer (solid tumors) that is advanced and/or metastatic
* Have a performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) scale

Exclusion Criteria:

* No symptomatic central nervous system (CNS) malignancy or metastasis
Subjects With Open-angle Glaucoma, Pseudoexfoliative Glaucoma, or Ocular Hypertension Naïve to Medical and Surgical Therapy, Treated With Two Trabecular Micro-bypass Stents (iStent)or Travoprost

Evaluation of the intraocular pressure (IOP) lowering effect of two iStent devices versus medical therapy in eyes of subjects with primary open-angle glaucoma, pseudoexfoliative glaucoma, or ocular hypertension naïve to medical and surgical therapy.

Evaluation of the intraocular pressure (IOP) lowering effect of two iStent devices versus medical therapy in eyes of subjects with primary open-angle glaucoma, pseudoexfoliative glaucoma, or ocular hypertension naïve to medical and surgical therapy.

Eligibility Criteria:
Inclusion Criteria:

* Phakic study eye
* IOP ≥ 21 mmHg and ≤ 40 mmHg at screening exam (OHT requires second screening)

Exclusion Criteria:

* Aphakic or pseudophakic eyes (AC-IOLs or PC-IOLs)
* Previous usage of topical prostaglandin analogues or prior medical therapy for glaucoma
An Audit of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy

Peritoneal carcinomatosis is a common event in the natural history of colorectal and other digestive tract cancers. Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) provides a promising therapeutic option for highly selected patients with peritoneal carcinomatosis arising from different malignancies such as colorectal cancer, gastric cancer, ovarian cancer, or peritoneal mesothelioma with improvement of both patient survival and quality of life. CRS, i.e., removal of all visible metastatic abdominal and pelvic disease with peritonectomy along with HIPEC (for 90 min at a temperature of 42º C) and/or early postoperative intraperitoneal chemotherapy (EPIC) in order to eradicate all microscopic metastasis.

CRS with HIPEC is a long and complex procedure with significant blood and fluid loss during debulking, hemodynamic, hematological, and metabolic alterations before and during the HIPEC phase, and even in the early postoperative period, with resultant significant morbidity and mortality. Despite that most of the reported patients are in American Society of Anesthesiologist class I and II, without significant comorbidities or systemic disorder; the morbidity and mortality ranges from 12 to 65% in these procedures, so a well coordinated team of anesthesiologist, surgeons and intensivist and other ancillary services can result in good outcome. This study will see the challenges faced by the team regarding the pathophysiological alterations during the CRS with HIPEC in the perioperative period.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 to 70 years
2. ASA Class I to III
3. Colorectal and gynecological oncology cases posted for CRS with HIPC.

Exclusion Criteria:

1. Age less than 18 and more than 70 years
2. ASA Class IV and above
Treatment of Hepatorenal Syndrome With Terlipressin Infusion Adjusted to Hemodynamic Response

Observe the effect of terlipressin on renal function in patients with SHR type I adjusting the dose based on hemodynamic response.


Eligibility Criteria:
Inclusion Criteria:

* Patients with hepatorenal syndrome type 1.
* Signed informed consent.
* No exclusion criteria.
* At least 18 years old
* Negative pregnancy test in serum or urine in women of childbearing age, and agree to use adequate contraception since at least 14 days prior to the first dose of study drug until 14 days after the last.

Exclusion Criteria:

* Hepatocellular carcinoma: exclusion of patients with hepatocellular carcinoma who present more than 3 nodules, single nodule larger than 5 cm, tumor portal thrombosis or extrahepatic tumor spread.
* Active bacterial infection with symptoms of systemic inflammatory response (fever, tachycardia, tachypnea, hypotension, septic or blood count).
* Cardiac or respiratory failure clinically significant.
* Clinically significant peripheral artery disease.
* A history of ischemic heart disease.
* Hypersensitivity to terlipressin and / or albumin or any of the excipients.
* Pregnancy.
* Septic shock.
* Chronic renal failure.
* Women in lactation
Aggressive Combination Drug Therapy in Very Early Polyarticular Juvenile Idiopathic Arthritis

The objective of this study is to compare in very early polyarticular juvenile idiopathic arthritis (JIA) the efficacy, safety, and cost-benefit-ratio of three treatment strategies: biologic combination, combination of conventional disease-modifying drugs (DMARDs), and methotrexate alone.

DMARD-naive polyarticular JIA patients with an early disease (onset less than 6 months) are randomized into one of three treatment strategies: (1) biological combination, i.e., anti-TNF therapy with infliximab plus methotrexate; (2) Combination of DMARDs with methotrexate, sulfasalazine, plus hydroxychloroquine; and (3) Methotrexate alone.

The efficacy is evaluated by American College of Rheumatology Pediatric (ACR Pedi) criteria based on 6 core set variables (CSVs): 1. no of active joints; 2. no. of joints with pain or tenderness and limitation of motion; 3. ESR (mm/hr); 4. the Childhood Health Assessment Questionnaire (CHAQ); 5. Physician's Visual Analogue Scale (VAS); 6. Patient/Parent VAS. To fulfill ACR Pedi 75 criteria, 3/6 CSVs have to improve 75% and not more than 1/6 CSV worsen more than 30%. All direct and indirect costs are documented.

The first phase of the study is open-label clinical trial lasting for 54 weeks. In the second phase of the study the patients are followed up to 5 years, and the long-term outcome of early aggressive therapy is analyzed. Serum, urine, and saliva samples are collected at 3 and 5 years for translational research.

Eligibility Criteria:
Inclusion Criteria:

* juvenile idiopathic arthritis
* arthritis lasting for at least 6 weeks but not more than 6 months
* polyarticular disease with at least 5 active joints with at least 3 joints with pain or tenderness and limitation of motion
* no previous treatment with DMARDs

Exclusion Criteria:

* systemic JIA
* any abnormality in the hematopoietic or lymphatic system
* any major concurrent medical condition
* inadequate psychosocial situation
* pregnancy
* a non-abstinent female with reproductive capacity without regular contraceptive use
ASSET 2 Study: Long-Term Follow-up of a Randomised Control Trial

This study aims to measure the long-term efficacy of arthroscopic Bankart repair for first-time anterior shoulder dislocation in terms of recurrent instability and functional outcome.

Approximately half of patients who experience a dislocation of their shoulder will go on to experience further problems with their shoulder. Some people will suffer persisting instability, and notice an uncomfortable feeling of their shoulder wanting to give way. This can occur commonly during active movements such as playing sports or lifting heavy objects. Some patients experience recurrent dislocations, and find that their shoulder is so weak that it slips out of joint with little provocation.

Previous research suggested that this high rate of subsequent shoulder problems can be greatly reduced (although not abolished completely) by surgery performed soon after the first dislocation. Ten years ago, there were two different methods which had been popularised:

1. Arthroscopic Wash-Out: The first is to wash out the shoulder joint with a sterile solution through an arthroscope (keyhole surgery) under a general anaesthetic.
2. Arthroscopic Repair: The second is to repair the torn tissues in the shoulder, again using key-hole surgery techniques under general anaesthetic.

A previous clinical trial was undertaken in our unit (2001-2005) which randomised young patients aged under 35 years to one of the two possible treatments (described above). These procedures were not new or experimental. The same Arthroscopic Repair technique continues to be routinely used in NHS Lothian to treat patients who have late problems following a dislocated shoulder. We do not routinely perform wash-outs of the shoulder joint because this is only effective in treating problems that occur at an early stage.This new study intends to build on these findings by asking each of the patient groups to complete a short questionnaire which uses validated outcomes to measure their shoulder function. The aim of the study is to identify if there is a long-term clinical and functional benefit of early arthroscopic shoulder stabilisation in high-risk patients.

Eligibility Criteria:
Inclusion Criteria:

* All patients who had previously enrolled in the previous study shall be considered eligible for inclusion.
* Aged between 25 and 55 years.

Exclusion Criteria:

* Patients will be excluded from this long-term follow-up if no contact details are available or if they no longer retained the capacity to provide consent to participate in the study
Pre-meal Load of Raw Almonds and Postprandial Hyperglycemia

A few studies show the effect of almonds on postprandial hyperglycemia (PPHG); high blood glucose after meals. In our previous study on intervention with almonds, we observed a significant decrease in HbA1C and a small decrease in fasting blood glucose indicating a possible effect of almonds on PPHG. Studies have shown that a preload of a food article that is high in protein, mono-unsaturated fatty acids, fiber, and low in carbohydrates, such as almonds could be helpful in stimulating insulin secretion and help improve postprandial hyperglycemia. The proposed study shall be undertaken to assess the effect of almond supplementation on postprandial hyperglycemia in Asian Indians with prediabetes.

* Acute Phase Study: Randomized controlled cross over study design Number of arms: 2, almond and control, n=60 needed (30 in each arm) Subjects randomized to almonds arm are given a preload of 20 g of almonds 30 minutes prior to ingestion of 75 g of glucose, while those in the control arm do not have any food/almonds before OGTT. Blood samples are collected at (minutes): -30, 30, 0, 30, 60, 90 and 120. Cross over of these subjects is done and OGTT repeated in a similar manner. Assessment of blood glucose, serum insulin, glucagon, C-peptide, serum triglycerides, free fatty acids, DPP-IV, and GLP1 levels are done at these time points.
* Sub-Acute Study:

Three-day almond preload study monitored with CGMS, n=60 needed. All study participants undergoing OGTT are further studied with CGMS for three days each and then crossed over. Those in almonds arm continue to receive preload of almonds (20g almonds, 30 minutes before breakfast, lunch and dinner)for three days and then studied without almond preload after cross over. A washout period of 7 days separates cross-over period.

o Chronic Phase Study: Ninety days almond preload study monitored with self-monitoring of blood glucose; n=60 needed.

This is a randomized controlled parallel-arm study to evaluate the long-term effect of preload of almonds on hyperglycemia. Subjects fulfilling the inclusion/exclusion criteria are randomized to either the control arm or the almond arm.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 60 years
* Prediabetes as diagnosed on oral glucose tolerance test (OGTT): Fasting blood glucose ≥100mg/dl and \<126 mg/dl and 2-h plasma glucose ≥140mg/dl and \<200mg/dl (after ingestion of 75 gram anhydrous oral glucose) or 2-h plasma glucose

  * 140mg/dl and \<200mg/dl alone.

Exclusion Criteria:

* Acute infections and advanced end-organ damage
* History of hepatitis or pancreatitis, abnormal liver and renal functions
* Recent (\<3 months) changes in weight (≥5%) and/or weight changing medications
* Any known allergy to nuts
* uncontrolled hypertension or hypothyroidism
* suffering from acute infection or any debilitating disease or with renal failure