cyrilzakka/clinical-trials huggingface dataset:
Exercise Dose-response and Protein Requirements

Study will investigate the impact of training volume on protein metabolism to estimate the impact on daily protein requirements of endurance athletes.


Eligibility Criteria:
Inclusion Criteria:

Healthy, male, endurance-trained participants who regularly run more than 40 km/week or perform endurance exercise for more than 4.5 hours/week

* Participants who have a self-reported 5-km run time of ≤23 min
* Participants who are categorized as at least "very good" based on a study by Shvartz \& Reibold (Aviat Space Environ Med. 1990 Jan;61(1):3-11), in which VO2peak is used as an index. (i.e. the participants whose VO2peak is ≥57 ml/kg/min (18-24 y), ≥54 ml/kg/min (25-29 y), ≥52 ml/kg/min (30-34 y), ≥49 ml/kg/min (35-39 y)
* Ability to complete the 16-km familiarization run on Session 2
* Aged 18-40 years old

Exclusion Criteria:

* - Inability to meet health and physical activity guidelines according to the PAR-Q+.
* Female: hormonal fluctuations associated with the menstrual cycle have been reported to alter protein metabolism during exercise and may influence specific amino acid requirements at rest; as such, the present study will test the effect of endurance exercise on protein requirements in males only to ensure a stable hormonal environment and to increase the homogeneity of the physiological response. (NOTE: we plan to test females in a future trial based off of the results obtained herein)
* Inability to adhere to any of the protocol guidelines (i.e. alcohol, caffeine consumption)
* Regular tobacco use
* Illicit drug use (e.g. growth hormone, testosterone, etc.)
Safety and Efficacy of Dexamethasone (OZURDEX®) Intravitreal Implant in Korea

This study is a Post-Market Surveillance study in Korea to evaluate the safety and efficacy of dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant used to treat Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, or non-infectious uveitis affecting the posterior segment of the eye in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, or non-infectious uveitis affecting the posterior segment of the eye treated with (OZURDEX®) in clinical practice.

Exclusion Criteria:

* Patients with eye infections
* Patients with glaucoma.
TIMING of Oral Anticoagulant Therapy in Acute Ischemic Stroke With Atrial Fibrillation

This study will compare early with late start of treatment with Non-vitamin K oral anticoagulation (NOAC) in adult patients with acute ischemic stroke and atrial fibrillation; it is a registry-based randomized clinical trial (R-RCT) using The Swedish Stroke Register (Riksstroke). Half of the patients will start NOAC early (within 4 days after stroke onset) while the other half will start late (5-10 days after stroke onset).

Oral anticoagulation therapy is well established and highly recommended for the prevention of recurrent ischemic stroke in patients with atrial fibrillation, but the optimal time point to start after an acute ischemic stroke is not known.

The intervention in this study will be timing of treatment onset. The choice of NOAC (i.e. apixaban, dabigatran, edoxaban or rivaroxaban) after the acute ischemic stroke is at the discretion of the treating physician.

This study will use the Swedish Stroke Register for enrolment, randomization and follow-up, with additional data linkage from other mandatory national registers. Primary outcome will be assessed at 90 days and secondary outcomes (including all-cause mortality and health economic analyses) and will be assessed at 90 days and up to one year after the index ischemic stroke.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥ 18 years) with acute ischemic stroke and atrial fibrillation
* Eligible and willing to start (or re-start) NOAC
* Registered in The Swedish Stroke Register
* Signed informed consent

Exclusion Criteria:

* Contraindication to NOAC (e.g. ongoing bleeding, mechanical heart valve prosthesis)
* Ongoing therapy with NOAC (without ≥2 days interruption at index stroke)
* International normalized ratio (INR)\>1.7
* No second brain imaging (CT/MRI) after thrombolysis/thrombectomy
* Previous randomization in the TIMING study
Evaluation of the Effect of Different Doses Dexmedetomidine Infusion on Lung Mechanics and Oxygenation in Obese Patients

• The objective of this study is to evaluate the effect of different doses of dexmedetomidine infusion intraoperative on lung mechanics and oxygenation regarding PaO2/Fraction of inspired oxygen), Intraoperative oxygenation, lung compliance (static and dynamic), dead space, and PaCO2,heart rate, mean arterial blood pressure in obese patients undergoing laparoscopic cancer surgeries

Dexmedetomidine is a selective agonist of α2receptorswhose tendency to α2 receptors is eight times more than that of clonidine. It also has powerful sedative, analgesic, anti-inﬂammatory, and organ protective properties. dexmedetomidine has favorable respiratory effects in humans. The effects of dexmedetomidine on oxygenation and lung mechanics had been investigated in obstructive lung disease. Dexmedetomidine decreased dead space and improved both lung compliance and oxygenation in chronic obstructive pulmonary disease (COPD) patients undergoing lung cancer surgery. Morbidly obese patients are characterized by the high prevalence of restrictive lung disease.The study include 2 equal groups, each group is 35 patients: Group A(N=35) dexmedetomidine is infused intraoperative after intubation at dose of (1μg/Kg LBW) bolus, followed by 0.5μg/Kg/hour continuous infusion till the end of surgery and Group B(N=35) dexmedetomidine is infused intraoperative after intubation at dose of (0.5μg/Kg LBW) bolus, followed by 0.3μg/Kg/hour continuous infusion till the end of surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-60years
* Obese patients BMI\>25 Kg/meter square
* Patients undergoing laparoscopic cancer surgery.

Exclusion Criteria:

* Heart failure
* Arrhythmias
* Severe liver or kidney impairment
* Patients with forced expiratory volume in 1 sec (FEV1)/FVC \< 70%
* Heart block
Factors Affecting Dialysis Associated Fatigue

The aim of this study is to investigate the factors affecting hemodialysis-associated fatigue and their impact on the physical and emotional well-being of patients. By identifying these factors, Investigators can develop effective strategies to reduce fatigue and enhance the overall quality of life for hemodialysis patients.

Chronic kidney disease (CKD) is a significant public health issue affecting millions of individuals worldwide. Hemodialysis, the most common modality for renal replacement therapy, is a life-sustaining procedure for end-stage renal disease (ESRD) patients. Despite its benefits, hemodialysis can be associated with various complications, and one of the most commonly reported symptoms is fatigue. Hemodialysis-associated fatigue (HAF) is characterized by persistent tiredness, lack of energy, and reduced motivation, which significantly impacts the quality of life and functional capacity of patients.

Several potential factors contribute to HAF, including patient-related variables, dialysis-related factors, and comorbidities. Understanding the underlying mechanisms and factors contributing to HAF is essential for improving the overall care and quality of life of hemodialysis patients. Targeted interventions to address fatigue could lead to better adherence to dialysis treatment, reduced hospitalizations, and enhanced overall well-being for this vulnerable patient population. To date, limited research has been conducted on the subject of HAF, and the available studies often have small sample sizes and diverse methodologies. Therefore, this research aims to delve into the complexities of HAF, exploring its prevalence, potential risk factors, and implications for patient outcomes.

Eligibility Criteria:
Inclusion Criteria:

* adult hemodialysis patients aged ≥ 18 years
* patients on hemodialysis for at least 3 months

Exclusion Criteria:

* patients aged \< 18 years
* patients with acute kidney injury
* patients with cognitive impairment or inability to provide informed consent
Smartphone Intervention for Overdose and COVID-19

This study will examine if the use of a smartphone application called Thrive4Life Connect can help people who use drugs lower their risk of overdose and learn more about COVID-19 vaccines. 60 participants will be enrolled and can expect to be on study for up to 6 months.

The mobile health system used in this study, called Thrive4Life Connect, has been developed for use in harm reduction settings with prior funding from the National Institute on Drug Abuse. Thrive4Life Connect is based on the Addiction Comprehensive Health Enhancement Support System (A-CHESS) and facilitates brief, behavioral interventions targeting knowledge gaps, motivation, and social connectedness. This app is being used in another study at University of Wisconsin-Madison (registered to NCT04268173).

The proposed study will develop new intervention content for assessing and increasing vaccine confidence and lowering overdose risk. The feasibility and preliminary efficacy will be tested using a pilot, pre-post study design with 60 people who have injected drugs in the past week and used opioids in the past 30 days. The investigators will examine feasibility outcomes based on study recruitment, retention, and intervention completion. Changes in knowledge about COVID-19 and overdose, motivation to reduce risk, and behavioral outcomes including overdose risk behaviors and vaccine uptake will be examined to establish preliminary efficacy.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* Willing to attend in person study encounters at any of the following Vivent Health locations: Milwaukee, Appleton, and Eau Claire
* Used opioids to get high in the past 30 days
* Injected drugs at least 2 times in the past 7 days
* Express interest in reducing their overdose risk

Exclusion Criteria:

* None in addition to the inclusion criteria
Congitive Behavioral Therapy Workshop for Content Moderators

Professional content moderators play a critical role in preventing Internet users from being exposed to more sensitive content. However, recent literature has shown that this work places content moderators at increased risk for several psychological outcomes, including intrusive thoughts and vicarious stress trauma. This pilot study will assess the acceptability and feasibility of a brief (4-session) cognitive-behavioral workshop to reduce these risks.

The growing amount of user-generated content is forcing companies to hire more and more content moderators (CMs). There is ample empirical evidence that exposure to the trauma of others at work affects well-being and mental health , and research focused on CMs suggests that they experience similar effects as other professionals. This includes an increased risk of developing syndromes such as secondary posttraumatic stress, vicarious trauma, and burnout. Recent literature, although limited, indicates that CMs are already using coping strategies such as creating boundaries between work and personal life, although they expressed a preference for individual therapy with specialized professionals. However, this initial work points to the need for technology companies to develop prevention programs based on preventing exposure to traumatic content (.

Therefore, a CBT workshop consisting of four 90-minute group sessions was designed specifically to prevent work-related consequences in a small sample of content moderators. The workshop will have a cognitive-behavioral orientation, which has been shown to be more effective for posttraumatic symptoms. Psychological distress, PTSD symptoms, job satisfaction, and coping strategies will be measured before and after the intervention to assess the feasibility of the workshop.

Eligibility Criteria:
Inclusion Criteria:

* Actively work as a professional content moderator, for at least 6 months.

Exclusion Criteria:

* Presence of a psychotic or personality disorder as defined by DSM-5 criteria.
* Receive another psychological treatment during the time of the study.
a Non-interventional Study of Sildenafil in the Treatment of Pulmonary Arterial Hypertension (PAH) in Adults From China

This observational study will involve analysis of data collected by the National Rare Disease Registry or medical records .The study will describe outcomes only in PAH(Pulmonary arterial hypertension) patients treated with sildenafil; there will be no comparison with another treatment group.

Approximately 100 adults with PAH will be recruited in China hospitals This NIS(non-interventional study) data will be recorded by a physician in the medical records, during the patients' clinical visits, and in the electronic Case Report Forms (CRF).


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age at study index date; (The index date (i.e., Day 1 of the study) is the date when the first sildenafil dose was actually taken, after Revatio® is approved by China authority)
* A diagnosis of PAH with a mean pulmonary artery pressure of ≥25 mmHg and a mean pulmonary capillary wedge pressure of ≤15 mmHg by right heart catheterization;
* Initiated sildenafil for the treatment of their PAH based on treatment suggestion from physician ;(Patients who have received sildenafil or are receiving sildenafil are eligible to participate in this study if they met the above inclusion criteria and were ready to start sildenafil (Revatio®) for treatment at screening;)
* Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* No
Thrombus Aspiration in ThrOmbus Containing culpRiT Lesions in Non-ST-Elevation Myocardial Infarction (TATORT-NSTEMI)

Whereas thrombus aspiration in patients with ST-elevation myocardial infarction (STEMI) is recommended by current guidelines, there are insufficient data to unequivocally support thrombectomy in patients with non-STEMI (NSTEMI). The Thrombus Aspiration in ThrOmbus containing culpRiT lesions in Non-ST-Elevation Myocardial Infarction (TATORT-NSTEMI) trial is a 400 patient, prospective, controlled, multicenter, randomized, open-label trial. The hypothesis is that under the background of early revascularization, adjunctive thrombectomy in comparison to conventional percutaneous coronary intervention (PCI) alone leads to less microvascular obstruction (MO) assessed by cardiac magnetic resonance imaging (CMR) in patients with NSTEMI. Patients will be randomized in a 1:1 fashion to one of the two treatment arms. The primary endpoint is the extent of MO assessed by CMR. Secondary endpoints include infarct size and myocardial salvage assessed by CMR, enzymatic infarct size as well as angiographic parameters, such as Thrombolysis in Myocardial Infarction-flow post-PCI and myocardial blush grade. Furthermore, clinical endpoints including death, myocardial reinfarction, target vessel revascularization and new congestive heart failure will be recorded at 6 and 12 months. Safety will be assessed by bleeding and stroke. In summary, the TATORT-NSTEMI trial has been designed to test the hypothesis that thrombectomy will improve myocardial perfusion in patients with NSTEMI and relevant thrombus burden in the culprit vessel reperfused by early PCI.


Eligibility Criteria:
Inclusion Criteria:

* ischemic symptoms such as angina pectoris \>20 minutes
* occurrence of last symptoms \<72 h before randomization
* cardiac troponin T or I levels above the 99th percentile
* culprit lesion containing thrombus (TIMI-thrombus grade 2-5 within the lesion) and intended early PCI

Exclusion Criteria:

* cardiogenic shock
* STEMI
* no identifiable culprit lesion or a TIMI-thrombus grade \<2
* coronary morphology ineligible for thrombectomy (e.g. very tortuous vessels, severe calcification)
* indication for acute bypass surgery
* age \<18 and \>90 years
* contraindications for treatment with heparin, aspirin or thienopyridines
* pregnancy
* current participation in another clinical study
* co-morbidity with limited life expectancy \<6 months
* contraindications to CMR at study entry
Contribution of PRF in CDH in Children With Prothetic Patch Closure

Improved management of giant congenital diaphragmatic hernias (CDH) in neonates : decreased risk of morbidity and mortality due to prosthesis release. CDH is a rare disease with a still very dark prognosis, with a high rate of morbidity and mortality in giants forms linked to the release of insufficiently biologically integrated prosthesis. The biological functionalization of the prosthetic materials by host PRF would improve the biological colonization of materials and thus reduce the risk of prosthetic release.


Eligibility Criteria:
Inclusion Criteria:

Adult Healthy Volunteers :

- Over 18 years of age

Neonates:

* Aged between 1h of life and 28 days of life
* Born beyond 33 Week of Amenorrhea + 1day and 2kg of birth weight
* Hospitalized in the medical-surgical centre of Pediatrics of the hospital of Strasbourg
* For whom a blood sample was prescribed as part of their routine care

Exclusion Criteria:

Adult Healthy Volunteers :

* Systemic inflammatory disease
* Transient inflammatory state
* Any drug that modifies the coagulation cascade during the 48h preceding the sampling

Neonates:

* Risk of anemia \< 7g/DL
* Current anticoagulant treatment
MiraLAX Versus Placebo to Prevent Constipation Following Urogynecologic Surgery

A. Purpose To compare MiraLAX versus placebo for preventing constipation in the immediate postoperative period following pelvic reconstructive surgery in women taking routine docusate sodium.

B. Objectives

1. Specific Aims Specific Aim 1: To compare time to first bowel movement (BM) between MiraLAX versus placebo in women receiving routine docusate sodium after pelvic reconstructive surgery.

   Specific Aim 2: To compare patient reported outcomes of BM quality and associated gastrointestinal (GI) symptoms between MiraLAX versus placebo using the Bristol stool scale and the validated Patient Assessment of Constipation Symptom Questionnaire (PAC-SYM) in women receiving routine docusate sodium after pelvic reconstructive surgery.

   Specific Aim 3: To evaluate GI-related quality of life between MiraLAX versus placebo utilizing the validated Patient Assessment of Constipation Quality-of-Life Questionnaire (PAC-QOL) in women receiving routine docusate sodium after pelvic reconstructive surgery.
2. Hypotheses The investigators hypothesize that MiraLAX will optimally prevent constipation following pelvic reconstructive surgery by decreasing time to first BM, decreasing GI symptoms associated with constipation, and increasing measures of GI-related quality of life, while minimizing the bothersome side effects associated with stimulant laxatives.

This is a randomized double-blind placebo-controlled clinical trial of MiraLAX versus placebo in women undergoing pelvic reconstructive surgery receiving routine docusate sodium. Subjects will be screened for eligibility during their preoperative visits and once enrolled, they will be randomized to receive MiraLAX or placebo starting on postoperative day (POD) 1 and continuing through POD 5. Subjects will be instructed to stop taking this medication if they experience any diarrhea. Subjects in both arms will be instructed to take milk of magnesia as a rescue laxative if they do not experience a BM by the morning of POD 6. All subjects will be provided a 30 day supply of docusate sodium and be instructed to begin this medication on POD 1.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking female patients
* \> 18 years of age
* Not pregnant (patients of childbearing potential will have a serum pregnancy test done pre-operatively as part of their surgical planning)
* Undergoing surgery for pelvic organ prolapse or stress urinary incontinence
* Recruited from the Duke University Division of Urogynecology

Exclusion Criteria:

* Allergy/hypersensitivity to study medications
* Cardiac or renal disease
* Takes chronic daily laxatives
* Excluded if unable to complete at least 5 days of a 7 day baseline bowel diary
* Excluded if mesh resection or Interstim procedure
* Excluded if concurrent surgery includes anal sphincteroplasty or rectovaginal fistula repair
Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO)

To determine the efficacy of vascular endothelial growth factor (VEGF) Trap-Eye injected into the eye on vision function in subjects with macular edema as a consequence of central retinal vein occlusion


Eligibility Criteria:
Inclusion Criteria:

* Center-involved macular edema secondary to central retinal vein occlusion (CRVO) for no longer than 9 months with mean central subfield thickness ≥ 250 μm on optical coherence tomography (OCT)
* Adults ≥ 18 years
* Early treatment diabetic retinopathy study (ETDRS) best corrected visual acuity (BCVA) of 20/40 to 20/320 (73 to 24 letters) in the study eye

Exclusion Criteria:

* Any prior treatment with anti-VEGF agents in the study eye (Pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc.) or previous administration of systemic anti-angiogenic medications
* Prior panretinal laser photocoagulation or macular laser photocoagulation in the study eye
* CRVO disease duration \> 9 months from date of diagnosis
* Previous use of intraocular corticosteroids in the study eye or use of periocular corticosteroids in the study eye within the 3 months prior to Day 1
* Iris neovascularization, vitreous hemorrhage, traction retinal detachment, or preretinal fibrosis involving the macula in either the study eye or fellow eye