cyrilzakka/clinical-trials huggingface dataset:
Re-evaluation of the Muscle-full Effect During Continuously Elevated Amino Acid Availability in Healthy Young Males

Muscle tissue consists of proteins. These proteins are built up of a collection of smaller building blocks: amino acids. When protein is consumed, it gets digested and absorbed into the blood. The body can use these amino acids, by taking them up from thecirculation. By consuming sufficient protein through our diet, we ensure that the body is provided with enough amino acids to enable muscle protein building. Sufficient muscle protein synthesis is important for maintaining muscle function and strength.

Previous research has shown that when 20 to 25g of protein is eaten, muscle protein synthesis is maximized. It is therefore recommended to eat 20g of protein per meal. However, it is currently unclear what happens to muscle protein synthesis rates if multiple meals are eaten. When multiple meals are consumed, amino acids appear in the circulation for prolonged period of time.

Theoretically, when there are a high amino acid concentrations in the blood, muscle protein synthesis rates will increase. Contrary to this theory, a study more than 20 years ago showed otherwise. It was observed that muscle protein synthesis rates are only elevated for2 hours afterwhich they decrease again. This phenomenon was referred to as the "muscle-full" effect. Because this phenomenon is in contrast with more previous studies, the objective is to replicate that study. This is important so that nutritional advice for healthy, but also clinical populations in the future can be improved.


Eligibility Criteria:
Inclusion Criteria:

* Male sex
* Aged between 18 - 35 years
* Healthy (assessed based on routine medical questionnaire)
* BMI between 18.5 - 30 kg/m2

Exclusion Criteria:

A potential subject who meets any of the following criteria will be excluded from participation in this study:

* Smoking
* Involved in progressive exercise training
* A history of neuromuscular problems
* Use of anticoagulants
* Recent (\<12 months) participation in amino acid tracer (L-\[ring-13C6\] phenylalanineand L-\[3,5-2H2\]-tyrosine) studies
* Use of medication known to affect (muscle) protein metabolism (e.g. corticosteroids, non-steroidal anti-inflammatory drugs, acne medication)
* Phenylketonuria
* Diagnosed with or history of liver damage
* Diagnosed with or history of severe kidney damage and/or malfunction
* Diagnosed with inability to break down amino acids
Brown Fat Activity and Bariatric Surgery

The mechanisms of bariatric surgery-induced weight loss go beyond reductions in calorie intake and may involve several other pathways. Recently, brown adipose tissue (BAT) has been added as another potential player. Activation of BAT results in enhanced energy expenditure and promotes weight loss. Here, the investigators will study the effects of bariatric surgery on BAT function by PET/CT studies and molecular analyses of adipose biopsies. The investigators will explore different pathways that may affect BAT activation in this patient population.


Eligibility Criteria:
Inclusion Criteria:

* Age 20 - 50 years
* Body mass index (BMI) 35 - 55kg/m2

Exclusion Criteria:

* Endocrine disease (except hyperlipidemia and substituted hypothyroidism or type 2 diabetes with fasting glucose concentrations \<120mg/dl), kidney disease, inflammatory bowel disease, autoimmune or rheumatologic diseases that require immunosuppressive treatment, active oncologic disease, heart failure.
* Medication for any of the above mentioned conditions.
* Antibiotic treatment in the past three months
* Pregnancy
Contralateral R1 in Amyotrophic Lateral Sclerosis

Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease affecting both upper and lower motor neurons. Electroneuromyography is an important tool for the diagnosis. Previous studies have shown that different components of the blink reflex, such as the latencies of homo- and contralateral R2 responses can be affected. Studies have found that a contralateral R1 component can appear in neurological diseases with affection of the central nervous system especially upper motor neuron, such as HTLV1 infection. Thus, you aim to determine if a contralateral R1 component could be present in ALS.


Eligibility Criteria:
Inclusion Criteria:

For patients

* Aged 18 to 99 years old
* Referred for suspected motor neuromuscular disease
* Collection of non-opposition

For healthy subjects:

* Aged 18 to 99 years old
* Absence of any neurological pathology
* Collection of non-opposition

Exclusion Criteria:

* Previous damage linked to another cause of the cranial nerves
* Prior brainstem lesions
* Persons deprived of liberty by a judicial or administrative decision
* Patient under judicial protection, unable to express consent
Creating African-American Wellness Through Exercise

The purpose of this study is to pilot-test a culturally-tailored, community-based educational program for African-Americans, focusing on how to use exercise and other self-management strategies to reduce depressive symptoms and improve health. This study will explore what type of additional support would encourage depressed African-Americans to exercise regularly. The investigators hypothesize that participants will report greater frequency of exercise and lower depression scores at the end of the program than they did at baseline. However, this study is not adequately powered to test this hypothesis - the main goal is to assess feasibility, acceptability and satisfaction of the pilot intervention.

Several studies have documented the effectiveness of exercise as a treatment for depression. However, these studies have used supervised exercise in medical school or university environments and have included mostly middle-class White populations. Little is known regarding how to translate these findings to real world settings or to minority populations. Exercise may be a particularly beneficial option for African-Americans suffering from depression. African-Americans face significant disparities in depression care. At least a part of these disparities are due to lack of trust in the healthcare system and negative attitudes toward antidepressants. Our goal is to pilot-test a culturally-tailored, community-based exercise support program for depressed African-Americans. We will recruit participants who screened positive for moderate depressive symptoms when they enrolled in the African-American Health Coalition's Free Exercise Card Program, but who are exercising less than 3 times per week. They will participate in a 6-week educational self-care group focusing on how to use exercise and other self-help tools to reduce depressive symptoms. Participants will be encouraged to create action plans regarding exercise and other healthy lifestyle changes. Groups will also provide culturally-tailored information about depression therapies, such as antidepressants and psychotherapy, and discuss strategies for obtaining quality health care.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age
* African-American or of African-American descent
* Currently participating in the African-American Health Coalition Free Exercise-Card Program
* Experiencing moderate depressive symptoms, as indicated by a score of 10-20 on the Depression Scale of the Patient Health Questionnaire (PHQ-9.
* Exercising less than three times per week (for a minimum of 30 minutes per session) over the past month

Exclusion Criteria:

* Actively suicidal
* If a health care provider, AAHC staff member, or an investigator feel that participation in the program may endanger the participant's health or safety.
* Known mental or cognitive impairments
* Known condition that precludes their ability to feasibly participate in a support group session.
Third Molar Clinical Trials: Pericoronitis Studies

The purpose of this research study is to find out if the infection around 3rd molars and the resulting inflammation around the gum also produces a general systemic inflammation.

Relate signs and symptoms of mild pericoronitis, an oral clinical condition characterized by intense inflammation and pain around a lower 3rd molar, to indicators of oral and systemic inflammation in patients seeking treatment for the condition.

Eligibility Criteria:
Inclusion Criteria:

* Mild signs/symptoms of pericoronitis affecting at least one lower 3rd molar with adjacent 2nd molar (spontaneous pain with localized swelling, purulence/drainage) with recommended treatment being removal of 3rd molars,
* Age 18 - 35 years,
* ASA I, II health status,
* AAP 1-3 periodontal status,
* Willingness to participate in the study,
* Geographic proximity to UNC.

Exclusion Criteria:

* Major signs/symptoms of pericoronitis (Temperature \>101 , dysphagia, limited mouth opening \<20mm incisor, facial swelling/cellulitis, severe uncontrolled discomfort),
* ASA III, IV health status,
* Medical contraindication to full mouth periodontal probing,
* AAP 4 periodontal status,
* Antibiotic treatment within the past 2 months,
* Current tobacco use,
* BMI \> 29,
* Pregnancy,
* Non English speaking.
The in Vivo Effect of Medical and Surgical Glaucoma Treatments on the Schlemm's Canal Micro-structure

The purpose of our current series of studies is to evaluate different glaucoma treatments in vivo effect on the conventional outflow pathway, and specifically on the Schlemm's canal (SC) anatomy using Enhanced Depth Imaging (EDI)-optical coherence tomography (OCT) . The images will be taken as part of the patients routine medical follow up (before starting the treatment, and 1,4 and 12 weeks afterwards) diameter, cross-sectional area and volume will be measured using commercially available 3-dimensional reconstruction.

The series of studies will be divided into 3 branches, each branch contains different treatments.For each treatment different patients will be recruited.

The branches are as following-

1. The surgical branch-

   1. Before and after trabeculotomy
   2. Before and after cataract surgery
   3. Before and after vitrectomy surgery
   4. Before and after XEN™ Gel Stent implant
2. The pharmacological branch-

   1. Before and during the treatment with prostaglandins analogs
   2. Before and during the treatment with alpha blockers
   3. Before and during the treatment with beta blockers
   4. Before and during the treatment with carbonic anhydrase inhibitor
3. The laser branch-

   1. Before and after trabeculoplasty
   2. Before and after laser iridotomy
   3. Before and after yag capsulotomy laser


Eligibility Criteria:
Inclusion Criteria:

1. Male or female of any race, at least 18 years of age.
2. Has provided verbal and written informed consent.
3. Able and willing to follow instructions, including participation in all study assessments and visits.
4. Has been referred to one of the treatments mentioned

Exclusion Criteria:

1. Has history of ocular conditions that may affect the SC structure (e.g., ocular neovascularization, anterior segment congenital anomalies)
2. Subject uncooperativeness that restricts adequate examination of IOP, ocular fundus or
3. any ocular or systemic conditions that may reduce OCT image quality (e.g., severe dry eye syndrome, visually significant cataract, limbal opacities, nystagmus, Parkinsonism, etc),
4. Pregnant women or male or female younger than 18 years of age
Evaluation of the Cost and Effectiveness Sunitinib Compared to Interferon-Alfa in Finland

Patient receiving sunitinib according the clinician's independent decision as first-line treatment of advanced renal cell carcinoma (RCC) will be asked for informed consent. Treatment with sunitinib will start and end solely on the treating clinicians and the patients independent discretion. Consenting patients will prospectively answer standardized quality of life questionnaires (15D, EQ-5D) during the treatment. Data on health care resource utilisation will be collected prospectively (outpatient visits, hospital stays, concomitant drugs, investigations, sick-leaves, travels). In addition, after treatment failure anti-cancer drugs, hospital stays and date of death will be recorded.

The health economic data during sunitinib treatment and the length of the sunitinib treatment will be compared with the corresponding previously published data collected retrospectively from patients with the same condition treated with IFN-alfa. Stepwise regression analysis will be used to explore whether patient and tumor characteristics explain potential variation in treatment duration and costs that is not explained by the treatment.

Health-related quality of life (HRQoL) data will be presented as descriptive data and compared to age-standardized general population.

At least four major Finnish oncology centers have consented to participate in this study. The inclusion time will be approximately 24 months, and the study time approximately 48 months. Eighty patients will be included.


Eligibility Criteria:
Inclusion Criteria:

* Clinically indicated first-line sunitinib treatment for advanced RCC.
* Informed consent obtained.

Exclusion Criteria:

* Unable to complete HRQoL forms.
* Not consenting to collecting register data.
Defining PET / CT Protocols With Optimized F18-FDG (Fluorodeoxyglucose) Dose, Focusing on Reduced Radiation Dose and Improved Image Quality

Identify the best combination of predictive variables that influence ionizing radiation dose and improved image quality through analysis and quantification of PET-CT images in simulators and patients.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers;
* Both genders;
* Age over 18 years;
* Clinical indication for PET-CT scan.

Exclusion Criteria:

* Pregnant women;
* Patients who have lesions in the liver metabolically active whether primary or metastatic;
* Patients with movement difficulties.
ADHD/Me Bibliotherapy Study

Attention-deficit/hyperactivity disorder (ADHD) is one of the most common neurodevelopmental disorders of childhood. It affects approximately 8% of school aged children and is characterized by persistent symptoms of inattention and/or hyperactivity/impulsivity. Typical ADHD assessments primarily involve interviewing the parents and gathering rating scales from parents and teachers. Feedback regarding diagnosis, clinical conceptualization, and treatment recommendations is usually provided by the clinical staff to the child's parents in the absence of the child. Hence, the ADHD diagnosis and repercussions of that diagnosis are often left unexplained to the child. Research has shown that bibliotherapy is an effective educational tool that can be used to help parents discuss ADHD diagnosis and treatment with their child. The aim of this study is to conduct a randomized trial in which tools for parents who are getting their elementary-aged (7 to 10-year-old) children evaluated for ADHD are explored. The evaluations (N=60) will be conducted at the Center for ADHD at Cincinnati Children's Hospital Medical Center (CCHMC) in Cincinnati, OH. Half of the families (n=30) will be randomly assigned to the intervention group, where they will be provided with the child-focused "ADH-Me!" book during the feedback session, and the remaining half will not receive it. All participants will receive a booklet with general information about ADHD and a list of recommendations from the clinicians. Approximately 3 months after their feedback sessions, follow-up surveys will be conducted via telephone to question the parents and children about their ADHD knowledge, as well as about whether they had followed up on the clinicians' recommendations. It is hypothesized that providing families with the ADH-Me! book will increase families' knowledge about ADHD and facilitate the family following up on treatment recommendations.


Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Meet ADHD criteria based on ADHD evaluation

Exclusion Criteria:

-
Remote Dielectric Sensing (ReDS) Assisted Diuresis in Acute Decompensated Heart Failure

This study evaluates the use of a wearable vest capable of non-invasively measuring lung fluid content in hospitalized patients with heart failure

Inpatient management of acute decompensated heart failure centers around the efficient relief of congestion with IV diuretics and vasoactive agents. For the majority of patients, non-invasive, clinical bedside tools such as jugular venous pressure, pulmonary auscultation and daily weights are used to estimate cardiac filling pressures and guide diuresis. However, these methods are subject to significant inter-observer variability and can be unreliable for various reasons. Furthermore, recent studies have shown that overt signs of clinical congestion correlate poorly with hemodynamic congestion assessed by invasive means. Remote Dielectric Sensing is a novel technology that enables the non-invasive assessment of lung fluid content using a wearable vest. ReDS measurements have been shown to correlate with fluid status in hospitalized HF patients and have been used to remotely monitor ambulatory HF patients for signs of pre-clinical hemodynamic congestion. In this prospective, randomized study, we will assess the utility of ReDS guided diuresis in hospitalized patients with acute decompensated heart failure. All patients will receive daily ReDS measurements, but only treating physicians in the intervention group will be able to use these values to guide treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalized for acute decompensated heart failure requiring treatment with intravenous diuretics and/or IV vasoactive drugs
* Patient has signed informed consent and has authorized use and disclosed health information
* Patient is at least 18 years of age
* Patient physically suitable for ReDS measurement
* GFR\>25
* Initial ReDS Measurement \>35%

Exclusion Criteria:

* Patient characteristics excluded from approved use of ReDS system: height less than 155cm or greater than 190cm, BMI \<22 or \>39, chest circumference \<80cm or \>115cm , or flail chest
* Evidence of focal lung lesions on history, physical exam or chest x-ray, including history of pulmonary embolism, active pneumonia, or known lung nodule
* Chronic renal failure (GFR\<25)
* Prior cardiac surgery within 2 months of index admission
* Patient has a ventricular assist device or has had a cardiac transplantation
* Patients in cardiogenic shock at admission requiring inotropic support
* Congenital heart malformations or intra-thoracic mass that would affect right-lung anatomy (e.g dextrocardia, lung carcinoma, or pacemaker box in the right chest)
Immunogenicity of Hepatitis B Vaccination in HIV-infected Adults

Uptake, adherence, and completion of vaccination among HIV-infected adults were low, and their immune function and immune response to hepatitis B vaccination were also suboptimal, indicating that the current practice of hepatitis B vaccination can't protect HIV-infected adults from HBV infection. And the persistence of immunity induced by hepatitis B vaccination remains a challenge.

This is a randomized, open-label trial, conducted among HIV-infected adults with drug rehabilitation. This study will compare the immunogenicity, immune persistence, and safety of three intramuscular 20µg and 60µg recombinant hepatitis B vaccines at months 0, 1, and 6 among HIV-infected adults.

Participants are randomized in a ratio of 1:1 into 20 µg recombinant hepatitis B vaccine group or 60µg recombinant hepatitis B vaccine group. The 20 µg group will receive three intramuscular injections of the 20 µg recombinant hepatitis B vaccine, while the 60 µg group will receive three intramuscular injections of the 60 µg dose at months 0, 1 and 6, respectively. HBsAg and anti-HBs will be tested during the study period. Adverse reactions will be recorded after vaccination.

Eligibility Criteria:
Inclusion Criteria:

* HIV-infected
* Aged between 18 and 70 years
* Serologically negative for hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody (anti-HBs) at enrollment
* Willing to adhere to the study protocol

Exclusion Criteria:

* Being pregnant
* Acute cytolysis in the last three months before enrollment
* Any vaccination before or during the month preceding enrollment
* Any Intolerance or allergy to any component of the vaccine
* Ongoing opportunistic infection
* Hematological disorder
* Cancer
* Unexplained fever the week before enrollment
* Immunosuppressive or immunomodulating treatment in the last six months
* Liver disease
Role of Curarization During Anesthesia for Laparoscopic Hysterectomy

The primary outcome of this study is to investigate whether deep NMB reversed with Sugammadex is superior to moderate NMB reversed with Neostigmine, in terms of overall pain in the first 48 hrs after laparoscopic hysterectomy, reversal time from NMB (TOF≥0.9) and direct and indirect costs. Additionally we will also assess: drugs consumption for pain and antiemetics (rescue dose), surgical conditions, hemodynamic and respiratory stability, operation time, anesthesia time, total amount and flow rate of CO2, insufflation time, resolution of post-operative ileus, dry mouth and PONV in the first 48 hours, patient satisfaction.


Eligibility Criteria:
Inclusion Criteria:

Age 18-75 years BMI between 16 and 40 Kg/m2 ECOG Performance Status tra 0 e 1 American Society Anesthesiologist (ASA) class 1 or 3 Able to provide informed consent to trial procedures

Exclusion Criteria:

* Age \< 18 or \> 75 years
* BMI \<16 o \> 40 Kg/m2
* ECOG Performance Status \>1
* Pregnancy
* Active or recent pelvic inflammation
* Anticipated airway difficulty
* Patients with history of allergy to rocuronium, neostigmine or sugammadex
* Allergy to NSAIDs
* Previous opioids consumption for chronic pain
* Patients receiving drugs for different medical conditions, that may prolong or shorten the duration of rocuronium effect (e.g aminoglycosides, magnesium)
* Hepatic or renal failure
* Persistent coagulopathy
* Neurological or cognitive disorders
* Conversion from laparoscopic to open surgery Onset of intraoperative complications
Novofine Autocover Safety Needle Versus BD Safety Glide

This trial is conducted in the United States of America (USA). The aim of this trial is to examine whether nurses prefer to use the NovoFine® Autocover Needle or the BD Safety Glide (TM) Syringe (only) in a hospital setting. The number of needle stick injuries will also be evaluated and whether these hospital nurses prefer the safety features of the NovoFine® Autocover Needle versus those of the BD Safety Glide (TM) Syringe. The identified hospital nurses will evaluate the two types of needles during standard administration of insulin to patients being treated for diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Hospital nurses with prior injection training without an infectious blood borne disease