cyrilzakka/clinical-trials huggingface dataset:
Comparison of Fatigue and Recovery After Stroke Depending on the Usual Management With or Without Physical Training

After a minor stroke, patients frequently report complaints such as fatigue and difficulty with certain everyday motor tasks, leading to a marked deterioration in their quality of life. The aim of this study is to show that the implementation of a personalised physical activity programme, starting 1 month after the hospitalisation for minor stroke, significantly decreases the frequency of fatigue in these patients, in comparison with usual management "in real life"..


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* National health insurance cover
* 1st minor ischaemic stroke (initial NIH score ≤ 4)
* Satisfactory neurological recovery at discharge from hospital (modified Rankin score ≤2)
* Patient living close to the participating centre (\<50 km)
* With early post-stroke fatigue (FFS score ≥ 4 at the definitive inclusion visit (W3))

Exclusion Criteria:

* haemorrhagic stroke
* History of ischaemic or haemorrhagic stroke with clinical manifestations
* History of TIA
* MMS ≤ 24
* Pre-existing dementia (defined according to DSM IV criteria)
* Neurosensory or orthopaedic disorders requiring permanent technical support before the stroke and making reconditioning impossible
* Aggravation of the neurological status after the initial hospitalisation (NIH score ≥ 6)
* Recurrence of the cerebrovascular event or onset of an acute cardio-vascular event between the screening and definitive inclusion
* Pre-stroke Rankin score ≥ 3
* Pregnant patient
* Patient under guardianship
Study to Investigate Comparative Efficacy, Safety and Immunogenicity Between AVT16 and Entyvio

The study has been designed as a randomised, parallel-group, double-blind, 2 arm study of the comparative efficacy, safety and immunogenicity of AVT16 and Entyvio in male and female subjects with moderate to severe active ulcerative colitis.

The study will consist of a screening period, a treatment and assessment period and an End of Study visit. Eligibility for the study will be determined during a screening period. Subjects who meet the eligibility criteria will be randomised to either AVT16 or Entyvio.

Eligibility Criteria:
Inclusion Criteria:

* Capable of giving signed informed consent
* Male and female subjects from 18 to 80 years of age
* Diagnosis of Ulcerative Colitis

Exclusion Criteria:

* Diagnosis of Crohn's colitis
* Extensive colonic resection
* Active or latent tuberculosis
The Significance of Arrhythmias in Athletes

Athletes with complex ventricular arrhythmias are potentially at risk of sudden death. The aim of the study is to investigate the relevance of ventricular tachyarrhythmias induced by an exercise test in a retrospectively evaluated athletic population.

Athletes with complex ventricular arrhythmias are potentially at risk of sudden death. The risk is increased when the athletes are engaged in competitive activities.

Ventricular premature beats (VPB's) are a common finding in the athletic heart. In the majority of cases these arrhythmias are part of the "athlete's heart syndrome" and do not increase the risk of sudden death in the athletes with an apparently normal heart. The data available in the literature deal with ventricular arrhythmias assessed only by 24-h ambulatory electrocardiograms.

To date, there are no guidelines concerning athletes who develop ventricular arrhythmias during a stress test. It is unclear whether they should be allowed to continue with their competitive activity or they should be denied to do so. A study looking at the long term follow-up of these athletes will help us determine whether the development of ventricular arrhythmia during a stress test imposes any risk on the athletes.

Eligibility Criteria:
Inclusion Criteria:

* Competitive athletes less than 35 YO
* Competitive athletes with ventricular arrhythmias on baseline or recovery in a stress test
* Competitive athletes with ventricular arrhythmia during exercise

Exclusion Criteria:

* Athletes who don't meet the exclusion criteria.
Impact of Light on Mood

The investigators are examining whether the content of a visual scene impacts the antidepressant effects of light or if this impact is solely mediated by the intensity of the light.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-60
* Mild depressive symptomatology

Exclusion Criteria:

* No depressive symptomatology
* Severe depressive symptomatology
* Active or unstable medical condition
* Diabetes
Water-only Fasting in the Treatment of Hypertension Patients

This purpose of this study is to examine the safety and feasibility of water-only fasting to treat hypertensive patients.

This is a prospective, open label, single arm, intervention study to examine the safety and feasibility of water-only fasting to treat hypertensive patients. Additional aims include describing mean changes in resting blood pressure as well as markers of cardiovascular health and inflammation between baseline and end of fast, end of refeed, 6-weeks post departure, and 12-months after 6-weeks follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Any gender
2. 30-75 years old
3. Diagnosis of Stage 1 or 2 hypertension
4. Fasting plasma glucose \<126mg/dL and/or hemoglobin A1c \<7 percent
5. Elect and qualify for a water-only fast of at least 7 consecutive days
6. Provide informed consent
7. Internet and computer access
8. Able to go to LabCorp for 6-week follow-up visit
9. Willing/able to collect 24-hour urine sample prior to water-only fasting

Exclusion Criteria:

1. Systolic Blood Pressure/Diastolic Blood Pressure \>180/120 mmHg
2. Active malignancy
3. Active kidney disease (creatinine over 2.0)
4. Active inflammatory disorder including classic autoimmune connective tissue (Lupus, Sjogrens, ANCA), multiple sclerosis, and inflammatory bowel disorders (Ulcerative colitis, Crohn's)
5. Stroke, heart attack, deep vein thrombosis, atrial fibrillation, anticoagulant therapy, or pulmonary embolism within the last 12 months
6. Inability to discontinue medications or supplements
7. Abdominal metal implants
8. Inability to consume only plant food for at least 48 hours before fast begins.
9. Unable to lay still on the back for at least 10 min.
A Study to Investigate the Long-term Safety and Efficacy of Tolvaptan in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Trial 156-04-251 in Japan]

ADPKD patients who enrolled in Trial 156-04-251 will receive repeated oral administration of tolvaptan twice daily (morning and evening: 45mg/15mg, 60mg/30mg, or 90mg/30mg).


Eligibility Criteria:
Inclusion Criteria:

* Patients who participated in Trial 156-04-251 in Japan and for whom CRF collection has been completed.
* Patients who completed 3-year repeated administration and who completed the second follow-up visit or patients whose treatment with the trial drug was interupted due to pregnancy and who completed out the second follow-up visit in Trial 156-04-251.
* Patients in whom any adverse events occurring in Trial 156-04-251 were resolved orstabilized and require no further follow-up.

Exclusion Criteria:

* Patients with eGFR of less than 15 mL/min/1.73 m2
* Pregnant, breast-feeding, or possibly pregnant women or women who are planning to become pregnant
* Patients who received any investigational drug other than Tolvaptan within 30 days prior to commencement of administration of tolvaptan
* Any patients who, in the opinion of the principle investigator or subinvestigators, should not participate in the study
Comparison of Attention of Physician After Outpatient Clinic

The attention and clinical performance of physician might be decreased after outpatient clinic session compared to those measured before outpatient clinic.

A large body of data shows that fatigue impairs human performance. Additionally, many studies have provided evidence that fatigue can worsen mood, as indicated by increased scores on measures of depression, anxiety, confusion, and anger. In this context, we examined attentional and emotional changes in physicians after they completed an overwhelming outpatient clinic in a university-affiliated tertiary referral hospital in South Korea.

Eligibility Criteria:
Inclusion Criteria:

* physicians with outpatient clinic sessions in Seoul National University Hospital
* age 30\~59
* internal part or external part

Exclusion Criteria:

* physicians who do not agree to participate in the study
* physicians who are taking drugs known to affect the sleep/wake cycle or daytime alertness
* physicians who have current psychiatric illness or sleep disorder
Comparative Effectiveness of Acute Low Back Pain Management

Current practice guidelines for patients with acute low back pain (LBP) recommend a stepped care approach with initial treatment of education and advice to remain active. Referral to physical therapy is considered only when patients fail to recover after a few weeks. Recent research has led to the identification a subgroup of patients likely to experience rapid, pronounced, and sustained decreases in disability and pain with a brief manipulation and exercise intervention, suggesting it may be more cost-effective to manage this sub-group with early referral to physical therapy instead of the usual care approach. The integration of this evidence into routine practice has not been evaluated. We will assess the outcomes of integrating this evidence into the management of patients with low back pain. The study is a randomized trial, comparing management with early manipulation with the current care process model. Patients fitting the inclusion criteria will be randomized into one of two groups. One group will be managed with the current care process model. The other group will be managed consistent with the decision rule recommending early referral for a brief manipulation and exercise intervention during the first 4 weeks. Patients will be followed over 1 year. Outcomes will include measures of disability, pain, satisfaction, and direct medical costs. The study will examine the costs and effectiveness of integrating the alternative care model into practice.


Eligibility Criteria:
Inclusion Criteria:

* Symptoms of pain and/or numbness between the 12th rib and buttocks with or without symptoms into one or both legs, which, in the opinion of the primary care provider, are originating from tissues of the lumbar region.
* Age 18 - 60 years
* Oswestry disability score \> 20%
* Both of the following clinical decision rule criteria: a)Duration of current symptoms \< 16 days; and b)Patient report of no symptoms (pain, numbness, etc.) distal to the knee in past 72 hours.

Exclusion Criteria:

* Prior surgery to the lumbosacral spine
* Any treatment for low back pain in past 6 months
* Current pregnancy
* Currently receiving treatment for LBP from another healthcare provider (e.g., chiropractic, massage therapy, injections, etc.)
* Presence of neurogenic LBP defined as the presence of either of the following:

  a) Positive ipsilateral or contralateral straight leg raise (reproduction of symptoms at \<45 degrees); or b)Reflex, sensory, or strength deficits in a pattern consistent with lumbar nerve root compression
* Judgment of the primary care provider of "red flags" of a potentially serious condition including cauda equina syndrome, major or rapidly progressing neurological deficit, fracture, cancer, infection or systemic disease
Pilot of Acupuncture to Improve Quality of Life in Veterans With TBI and PTSD

The purpose of this study is to examine if acupuncture improves Post-Traumatic Stress Disorder symptoms among veterans who participated in Operations Enduring Freedom and Iraqi Freedom. This study will also examine the degree of veteran acceptance for acupuncture.

Project Background: Acupuncture can be effective for many of the specific co-morbidities that make up war-related Trauma Spectrum Disorder in both TBI and PTSD patients, including pain, stress and anxiety, insomnia, somatic and post-operative pain. Recent studies find very large effect sizes (Cohen's D .85 to 1.4). Thus, there is good reason to believe that acupuncture will induce recovery across a number of trauma spectrum dysfunctions in patients with TBI and PTSD, at low cost and with little risk.

Project Objectives: The overall objective of this application is to determine the efficacy of adjunctive acupuncture for improving quality of life and function and alleviating co-morbidities associated with TBI and PTSD in service members injured in the current wars. The primary hypothesis of this study is: OIF/OEF veterans who screen positive for TBI or PTSD and are treated with a 12 week standard individualized acupuncture method will experience improved HRQL (as measured by the Veteran's SF-36) at 6, 12 and 24 week follow-up, compared to veterans randomly assigned to standard care alone.

Project Methods: This is a pilot study on veterans who screen positive for TBI or PTSD in the VA healthcare record, which is being submitted to obtain additional pilot data, confirmation of recruitment strategies, and information on non-participants . Frequency distribution and summary statistics for demographics and baseline variables will be presented by intervention group and for all subjects combined. Key demographic variables to be summarized are: age, gender, time to deployment, number of deployments, and diagnosis. Key baseline variables are: PTSD CAPS score, VSF-36, and ANAM score.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis or positive screen test for PTSD.
* Combat veterans of Operation Iraqi Freedom or Operation Enduring Freedom conflicts.

Exclusion Criteria:

* Unable to travel to East Orange VA for 12 consecutive weeks, biweekly for treatment.
* Does not speak English.
* Acupuncture or CBT treatment within the previous six months.
Repeated Injection of GnRH Agonist to Reduce Ovarian Hyperstimulation Syndrome

Gonadotropin releasing hormone (GnRH) agonist is sufficient for triggering final oocyte maturation in GnRH antagonist protocol and can significantly reduce incidence of ovarian hyperstimulation syndrome (OHSS) in high-risk patients.

However, lower oocyte yield was reported in patients with lower luteinizing hormone (LH) level post trigger with single injection of GnRH agonist, which might be related to the shorter duration and lower amount of LH induced by GnRH agonist.

Our aim is to study repeated injection of GnRH agonist for preventing OHSS and maintaining clinical outcome in high risk patients who receive controlled ovarian stimulation in GnRH antagonist protocol.

This was a prospective cohort study of all women attending the Center for Reproductive Medicine, Department of Gynecology and Obstetrics, Nanfang Hospital, affiliated with Southern Medical University for in vitro fertilization and/or intracytoplasmic sperm injection . Women at high risk of OHSS who received IVF and/or intracytoplasmic sperm injection (ICSI) treatment with a flexible GnRH antagonist protocol were recruited to participate in this study.

All patients underwent standard ovarian stimulation protocol with gonadotropins, standard individualized adjustment of medication dose, and standard egg retrieval procedure. Patients were triggered with a single bolus of 0.2 mg triptorelin at night and had second injection of 0.2 mg triptorelin 12 hours later when the criteria for administration of the ovulation trigger were met.

Eligibility Criteria:
Inclusion Criteria:

* patients with polycystic ovarian syndrome
* patients with polycystic ovarian morphology on ultrasound
* patients who previously experienced an ovarian stimulation cycle, with a high response to gonadotrophins

Exclusion Criteria:

* patients undergoing coasting
* patients with past ovarian surgery
Investigation of AVACEN Thermal Exchange System for Fibromyalgia Pain

Hypothesis: Daily use of the AVACEN Thermal Exchange System for 4 weeks will show improved Fibromyalgia pain and functioning markers, as assessed by biomarkers and clinical and psychological assessment. This non-invasive device is able to rapidly raise the core body temperature of the user by placing a hand in a vacuum chamber and resting it upon a heating element. The change in body temperature may change the sympathetic nervous system's activity and thereby reduce Fibromyalgia pain.


Eligibility Criteria:
Inclusion Criteria:

* Fibromyalgia diagnosis
* Over the age of 18
* Understands English
* Not pregnant/planning to become pregnant
* Average pain of 4 or greater over the last week (10 point scale)
* Fibromyalgia pain lasting longer than 6 months

Exclusion Criteria:

* Pregnant/Planning to become pregnant
* Major unstable psychiatric illness
* Major, uncontrolled systemic illness for which you may be hospitalized in the next 6 months
Pegs for Osteofixation of Proximal Humeral Fractures

Patients treated operative for Proximal humeral fractures with angular stable device (Philos plate or ALPS-PHP)

From a cohort of patients treated for displaced Proximal humeral fractures (PHF) in the period July 2017 - August 2019 patients with the 11-B2 and 11-C2 PHF according to AO/OTA 2007 fracture classification were selected according to age and gender to be compared with patients operated with a Philos plate within the same fracture group, age and gender to be matched for adverse events:

1. Radiographic evidence of penetration of pegs (ALPS-PHP) or screws (Philos) into the glenohumeral joint (primary outcome) and
2. Avascular head necrosis / sinking / need of re-surgery
3. Clinical PROMS

Eligibility Criteria:
Inclusion Criterion:

* Acute proximal humeral fracture
* AO/OTA type 11-B2 or 11C2

Exclusion Criteria:

* Not eligible to surgical treatment
* Non-compliant
* Former shoulder fracture or symptomatic shoulder illness
* Drug abuser
A Trial of Preoperative MM-121 With Paclitaxel in HER2-negative Breast Cancer

To demonstrate whether addition of MM-121 to paclitaxel is more effective than treatment with paclitaxel alone, when administered as part of the neoadjuvant treatment in Her2 negative locally advanced operable breast cancer patients.

This is a multicenter, open-label, randomized, Phase II study of preoperative MM-121 with paclitaxel in HER2-negative breast cancer. Patients will be randomized to receive paclitaxel with or without MM-121 for 12 weeks followed by 4 cycles of doxorubicin plus cyclophosphamide and subsequent surgery.

Eligibility Criteria:
Inclusion Criteria:

* Histological confirmation of ER positive, HER2 negative invasive breast cancer (Group 1) or invasive triple-negative breast cancer (Group 2)
* Free of metastatic disease
* ≥ 18 years old
* Female
* Had no prior treatment for any cancer
* Eligible for treatment with paclitaxel, doxorubicin and cyclophosphamide

Exclusion Criteria:

* Have a history of severe allergic reactions to paclitaxel or other drugs formulated in Cremaphor® EL
* Are pregnant or breastfeeding
Optimized Cardioprotection Therapy in Obese Subjects With CAD

The purpose of this study is to investigate the efficacy and mechanism of Adipokines Cardiac Protection in Obese Patients With coronary artery disease (CAD).

Adipokines (or adipocytokines) can be defined as a group of more than 600 bioactive molecules made from adipose tissue that acts as paracrine and endocrine hormones. Adipokines are involved in maintaining varieties of processes such as, appetite and satiety, energy expenditure activity, endothelial function, blood pressure, hemostasis, adipogenesis, insulin sensitivity, energy metabolism in insulin-sensitive tissues, fat distribution and insulin secretion in pancreatic β-cells. Adipokines may contribute to reduce scar formation and improve cardiac function in coronary artery disease (CAD). Reperfusion therapy such as percutaneous coronary intervention (PCI) should be administered to all eligible patients with CAD symptom. However, our previous work showed that obese patients may benefit more from PCI. Thus, the aim of the present study was to investigate the efficacy and mechanism of adipokines cardiac protection for obese and non-obese patients with coronary artery disease (CAD).

Eligibility Criteria:
Inclusion Criteria:

coronary artery disease according to the WHO definition With or without percutaneous coronary intervention

Exclusion Criteria:

previous Coronary artery bypass grafting (CABG) cardiomyopathy atrial fibrillation or flutter previous heart surgery severe valvular heart disease disease of the hematopoietic system NYHA functional class IV heart failure at baseline severe renal, lung and liver disease cancer
Prevention of Post-Cardiac Surgery Acute Kidney Injury by Proton Pump Inhibitor

The purpose of this study is to determine whether perioperative intravenous administration of pantoprazole will improve kidney function parameters following cardiac surgery with cardiopulmonary bypass compared to famotidine and to determine whether perioperative intravenous administration of pantoprazole will decrease the incidence of postoperative Acte Kidney Injury (AKI) and major adverse kidney events (MAKE).

Each year more than 500,000 cardiac surgeries are performed in the United States of America (USA) alone. Acute kidney injury ( AK) I is a common complication following cardiac surgery and is associated with poor patient outcomes and increased healthcare costs. Therefore, there is an urgent need to identify medical interventions and treatments that prevent AKI or mitigate its severity when it occurs after cardiac surgery.

One of the main causes of AKI following cardiac surgery involves renal hypoperfusion/ischemia and reperfusion injury. Hypoxia-inducible factors (HIFs) are key transcription factors responsible for tissue adaptation to low oxygen, which orchestrate the expression of a wide variety of genes including a set of micro-ribonucleic acid (microRNAs). MicroRNAs are endogenous single-stranded noncoding miRNAs of nucleotides that participate in physiological and pathological functions via regulating post-transcription of target genes. During ischemic injury, hypoxia upregulates endothelial MicroRNAs that has the potential in renal protection through vascular integrity and regeneration. Additionally, microRNAs exert protective effects via decreasing apoptosis and promoting tubular cell proliferation during ischemic AKI.

Moreover, decreased serum levels of MicroRNAs are highly correlated with AKI severity in the intensive care unit (ICU) patients. Our preliminary study identified ATP4A as the downstream target gene of MicroRNAs in the kidney. Adenosine triphosphate (ATP)4A (catalytic α subunit of H+/K+ ATPase) is located in intercalated cells in the distal tubules and cortical collecting ducts, which regulates urine acidification through secretion of hydrogen and reabsorption of potassium from urine. Proton pump inhibitors (PPIs) block the ATP hydrolysis of the H+/K+ ATPase via binding its active site of ATP4A and further enhance this endogenous kidney protection pathway. Despite robust animal model data, randomized controlled trial aiming to test the effectiveness of PPI in post-cardiac surgery AKI prevention is lacking. If proven to be effective, our studies could be easily implemented in clinical practice and serve as an effective treatment for perioperative AKI.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for elective cardiac surgery with cardio pulmonary bypass (CPB) with a moderate to high risk of developing AKI (Cleveland risk score equal or higher than 3)

Exclusion Criteria:

* Preoperative eGFR\<30 ml/min per 1.73 m2
* Dialysis dependence
* Emergency surgery
* Interstitial nephritis
* Pregnancy
* Nursing Patients
* Proton pump inhibitors (PPIs) hypersensitivity
* Liver disease
* Vitamin B12 deficiency