cyrilzakka/clinical-trials huggingface dataset:
Does Dietary Nitrate Supplementation Improve Aerobic Performance

The purpose of this study is to determine whether dietary nitrate supplementation improves performance in cardiopulmonary exercise testing (CPET).

Dietary nitrate supplementation has been shown to enhance exercise tolerance and performance in professional athletes and physically active males.

Cardiopulmonary exercise testing (CPET) is an established, non invasive and safe method of assessing patients' cardiopulmonary reserve prior to surgery. It has been shown to predict complications and length of stay in patients undergoing major elective surgery.

The anaerobic threshold (AT), the oxygen uptake at which anaerobic ATP synthesis supplements aerobic ATP synthesis and the maximal oxygen uptake (VO2max) the point where the oxygen uptake plateaus despite an increase in work rate; both calculated during CPET; have both been shown to predict short and long term outcomes after surgery and postoperative complications.

We aim to study the effect of dietary nitrate supplementation on CPET results in patients awaiting surgery for colorectal cancer.

Our primary outcome will be the change in the AT and VO2Max after beetroot juice supplementation.

Methods: Patients will undergo an initial CPET and will then be randomized to receive either beetroot juice (BRJ, containing NO3-, 6.2 mmol/day, administered as 500ml Beet it Sport Shots, James White drinks, Ipswich uk) or 'placebo' (PL, NO3-depleted beetroot juice) for 7 days. A second CPET will then be performed.

This pilot study will be used to calculate the mean AT and VO2Max and associated standard deviations for our population and the approximate effect of BRJ on them.

Eligibility Criteria:
Inclusion Criteria:

* Elective Colonic or rectal resection.

Exclusion Criteria:

* Contraindication to cardiopulmonary exercise testing: unstable cardiac disease, lower limb dysfunction, inability to perform CPET
* Inability to give informed consent
* Emergency surgery
* During CPET: Ischemic ECG or inability to reach AT
* Allergy to Beetroot
Questionnaire Survey of the Advanced Training Program for Laparoscopic Radical Gastrectomy

This study aims to evaluate the outcomes of the advanced training program for laparoscopic radical gastrectomy (ATP-LRG). The research subjects are the trainees who participated in this training program.

Written informed consent is not required because of the observational and anonymous nature of this study. ATP-LRG is a national training program carried out by Fujian Medical University Union Hospital. Each training lasts about 1.5 days, which includes 1) detailed technique description; 2) prevention and solving of intraoperative complications; 3) live surgery performance; 4) theory and practice of clinical research; 5) comments on trainees' videos; and 6) questions, answers and discussions. In this study, 875 trainees who participated in ATP-LRG from January 2015 to October 2020 were interviewed using electronic questionnaires. Using a repeated-measures design to examine differences in outcomes before and after participating in the training. Questionnaire Star (Changsha Ranxing Information Technology Co., Ltd), a most widely used professional online questionnaire software platform in China, was used to design and create a link to the questionnaire. The questionnaire's link was sent to each trainee via WeChat (Tencent Holdings Limited), the most commonly used social networking software in China.

Eligibility Criteria:
Inclusion Criteria:

* Participated in ATP-LRG between January 2015 and October 2020
* Have contact information

Exclusion Criteria:

* Repeated participation in ATP-LRG
* Refuse to fill out the questionnaire
Heart Rate Changes During Normal Activity, Exercise, and Sleep in Normal Healthy Subjects With and Without Epilepsy

The purpose of this study is to gather ECG data during normal activity, exercise, and sleep from normal subjects with or without well-controlled epilepsy. This normal subject data will serve as "true negative" (i.e., no seizure occurring) challenge data for testing cardiac based seizure detection algorithms.

The purpose of this study is to gather ECG data during normal activity, exercise, and sleep from normal subjects with or without well-controlled epilepsy. This normal subject data will serve as "true negative" (i.e., no seizure occurring) challenge data for testing cardiac based seizure detection algorithms.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects must be 18 years or older and may be of either sex and of any race.
2. Subject must be in good general health, fully ambulatory, and able to complete the physical aspects of testing requirements.
3. Subject must be willing and able to complete informed consent and HIPAA authorization.
4. Subject may be diagnosed with epilepsy but must be well controlled on their regular treatment regimen.
5. Women of childbearing potential must have a negative urine pregnancy test.

Exclusion Criteria:

1. Subjects with skin abnormalities or conditions that would interfere with ECG electrode patch placement or cause subject discomfort with patch placement.
2. Subjects report history of allergies or sensitivity to adhesive tapes or patches.
3. Subjects with severe psychiatric disease that in the investigator's judgment would prevent the subject's successful completion of the study.
4. Subjects with epilepsy experiencing status epilepticus within the last 6 months.
5. Subjects with cardiovascular, respiratory, neuromuscular or gait disorders that in the investigator's judgment would cause unnecessary risk or inability to participate in the protocol.
6. Subjects with known cardiovascular arrhythmias or cardiac disease resulting in history of cardiac disease or abnormal ECG recordings. These include, but are not limited to, conditions such as chronic atrial fibrillation and permanent cardiac pacemaker implantation.
7. Use of beta adrenergic antagonists (i.e., "beta blockers") or calcium channel blocker agents that may affect heart rate.
8. Subjects currently dependent on alcohol or narcotic drugs as defined by DSM IV-TR.
Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohn's Disease

The primary objectives of this study are to evaluate the safety and efficacy of filgotinib during induction and maintenance treatment of moderately to severely active Crohn's disease (CD) in participants who are biologic-naive and biologic-experienced.

Participants who complete the study, or do not meet protocol response or remission criteria at Week 10 will have the option to enter a separate long-term extension (LTE) study (Study GS-US-419-3896).


Eligibility Criteria:
Key Inclusion Criteria:

* Documented diagnosis of CD with a minimum disease duration of 3 months with involvement of the ileum and/or colon at a minimum, as determined by histopathology and endoscopic assessment
* Moderately to severely active CD
* Cohort A (Biologic Naïve): Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents (depending on current country treatment recommendations/guidelines): corticosteroids and immunomodulators
* Cohort A (Biologic Experienced): Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents (depending on current country treatment recommendations/guidelines) or discontinuation of use of at least one of the following agents for reasons other than inadequate clinical response, loss of response or intolerance: tumor necrosis factor alpha (TNFa) antagonists, vedolizumab, and ustekinumab
* Cohort B (Biologic Experienced): Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents (depending on current country treatment recommendations/guidelines): TNFa antagonists, vedolizumab, and ustekinumab

Key Exclusion Criteria:

* Current complications of CD such as symptomatic strictures, severe rectal/anal stenosis, fistulae other than perianal fistulae, short bowel syndrome, etc.
* Presence of ulcerative colitis, indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon
* Active tuberculosis (TB) or history of latent TB that has not been treated
* Use of any prohibited concomitant medications as described in the study protocol

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Study on the Possible Effects of Diet Supplementation With Essential Fatty Acids in Chocolate Craving Volunteers

The purpose of this study is to determine whether essential polyunsaturated acids (omega 3) are capable of reducing chocolate craving symptoms in healthy patients.

Our hypothesis is that the omega 3 fatty acids have properties which stabilize and normalize neuronal functioning in many conditions, including chocolate craving.

Polyunsaturated fatty acids (of the omega 3 subtype) are fundamental in human diet, as they are components of cellular membranes, guaranteeing their fluidity and their functions of separating intracellular and extracellular means and transporting several substances to and from cellular microenvironment.

Modern theories profess that lack of omega 3 fatty acids in western diets may be the cause of several deletery changes in neuronal physiology, which may cause or make worse several pathological conditions, such as depression, mood instability, and drug craving. The role of serotonin as the main lacking component in the conditions is well documented, and it is thought that omega 3 is important in the synthesis, transportation, and ultimately the activity of this neurotransmitter.

Out theory states that supplementation with these acids can restore normal neuron balance, improving the condition of chocolate craving patients.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of chocolate compulsion or craving, ECAP score \> 12.

Exclusion Criteria:

* Psychiatric disease of any sort (by the DSM IV criteria, Use of psychoactive drugs of any sort, BMI \> 25 (kg/m2).
Hyperosmolar Saline Irrigation Fluid in Arthroscopic Knee Surgery

An isotonic solution, such as saline (0.9%, 300mOsm/L) or lactated ringer's (273 mOsm/L), is commonly used and safely proven for joint irrigation during arthroscopy. Arthroscopic fluid is usually pressurized to enable visualization through dilation of the joint or bursa and prevent bleeding from the microvasculature. It has been recommended that this pressure be maintained at 49mmHg or less below the systolic blood pressure to preserve the clarity of view. The combination of large amounts of pressurized irrigation solution and lengthy arthroscopic procedures may cause substantial tissue fluid retention. Thus, extravasation of irrigation fluid into the periarticular tissues is inevitable and may create technical difficulties as well as patient morbidity and complications. Previous investigators have reported complications including tracheal obstruction, post-operative airway edema and compromise leading to prolonged intubation, excess weight gain, neurologic injuries, skin necrosis, and fluid overload associated with excessive fluid extravasation and tissue retention. Furthermore, it has been shown that fluid accumulated during the operation is slowly released back into the systemic circulation. Although there is not a rapid change in circulating volume, there may be implications for elderly patients and those with multiple comorbidities during prolonged arthroscopic surgery. Therefore the investigators seek to determine if a hyperosmolar solution, similar to what is used in head trauma patients, can reduce the degree of fluid extravasation in knee arthroscopy. The investigators also seek to determine if a hyperosmolar solution has any effect on post-operative knee pain compared to the standard isotonic solution. The third objective is to determine if a hyperosmolar solution has any effect on post-operative pain medicine consumption compared to the standard isotonic solution.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18 years of age or greater) undergoing arthroscopic knee surgery who are willing and able to consent.

Exclusion Criteria:

* Current pregnancy or breastfeeding
* Unable to give consent
* Prisoner
* Mentally Disabled
The SEA CHANGE Study: A Self Management Intervention for Head and Neck Cancer Survivors

This study aims to test the feasibility of implementing the Self-Management after Cancer of the Head and Neck Group Intervention (SEA-CHANGE), designed to promote quality of life and participation in life activities and reduce distress in people who have completed primary treatment for head and neck cancer as compared to usual care.

Head and neck cancer (HNC) and its treatment are associated with specific challenges such as facial disfigurement and impairments in speech, breathing and swallowing, and can have a negative impact on well-being. Self-management interventions can provide people with skills to deal with health-related problems, maintain life roles, and manage negative emotions, and have been found to increase confidence, improve quality of life, and reduce health service use across a range of chronic conditions.

The aim of this study is to pilot a self-management intervention (SEA-CHANGE) designed to promote quality of life and participation in life activities, and reduce distress in people who have completed primary treatment for HNC as compared to usual care. The study includes: (1) a pilot randomised study to assess the feasibility and acceptability of the intervention and its related procedures; (2) a qualitative process evaluation of the intervention; and (3) a systematic decision-making process regarding progression to a definitive trial. The expected outcome is a self-management intervention that is feasible and acceptable to HNC survivors and has the potential to realise both health benefits and economic gains.

Eligibility Criteria:
Inclusion Criteria:

* had a pathologically confirmed diagnosis of an invasive primary tumour in the head and neck (oral cavity, salivary glands, nasal cavity, sinuses, middle ear, pharynx and larynx);
* have undergone and completed treatment by surgery, chemotherapy, radiotherapy or a combination thereof;
* are aged 18 or older at the time of their HNC diagnosis;
* are within 12 months of having completed their primary treatment; and
* have provided written informed, consent.

Exclusion Criteria:

* are unable to read or speak English;
* had a second invasive primary cancer other than non-melanoma skin cancer diagnosed after the HNC (as these patients are likely to be more focused on the treatment of their second cancer rather than self-management of their HNC);
* are unable to provide informed consent (e.g., if they have dementia/Alzheimer's disease); or
* have other known medical condition or other reason why they would be unable to take part.
Amisulpride in Schizophrenic Acute Phase Patients

To collect the safety and response of using Amisulpride in acute schizophrenic patients


Eligibility Criteria:
Inclusion Criteria:

* Patient diagnosed as Diagnostic and Statistical Manual of Mental Disorder, 4th edition, as paranoid, disorganized or undifferentiated type of schizophrenia in acute episode

Exclusion Criteria:

* Patients previously treated with amisulpride
* Patients have comorbidity which may interfere with the treatment or follow-up
* Patients currently taking depot antipsychotics (at least 30 days washout period is needed)
* Patients currently/ or recently (\< 3 months) withdrawn from drug or alcohol abuse
* Pregnant or lactation

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Age and Insulin Resistance

Insulin resistance is a crucial factor for the development of type 2 diabetes and a major health problem for older adults. It is the principal mechanism by which obesity is considered to increase the risk for type 2 diabetes and is a key feature of the metabolic syndrome. The elevated prevalence of obesity and type 2 diabetes in the older population has important consequences on the morbidity and mortality as well as on the economic burden on society. Controversy currently exists as to whether or not aging contributes to insulin resistance. Many potential factors confound the association between aging and insulin resistance, including obesity and physical inactivity.

Ectopic lipid depositions, defined as an excess accumulation of triglycerides in non adipose tissues such as in the liver (intrahepatic lipids) and within the muscle fibers (intramyocellular lipids), are positively associated with obesity and insulin resistance. Furthermore, the accumulation of intracellular lipids is often cited as being a key determinant in the underlying mechanisms of insulin resistance. In addition of playing an important role in obesity and type 2 diabetes, these ectopic fat depositions are also observed in common conditions such as aging and physical inactivity.

The intervention trial will test in skeletal muscle, liver and heart of sedentary obese volunteers, normal weight volunteers and masters athletes, the overall hypotheses that exercise improvement of fat oxidation capacity and/or decrease of damaging fat metabolites is a primary factor that predicts the improvement in insulin resistance.


Eligibility Criteria:
Inclusion Criteria:

* Age 60-80
* Sedentary or highly trained
* BMI 18-40
* Non-Smoker
* Normal glucose tolerance or impaired glucose tolerance
* Willingness to comply with the protocol

Exclusion Criteria:

* Contraindication to moderate exercise or clinical conditions precluding from joining an exercise program, such as clinically significant cardiovascular disease, peripheral vascular disease, uncontrolled hypertension, neurological or orthopedic disease
* Recent weight loss or weight gain
* Known diabetes
* Known drugs to affect glucose homeostasis such as nicotinic acid, glucocorticoids
* Severe anemia or lipid disturbances, hepatic or renal disease
* Recent history of cancer
* Hypothyroidism
* Recent hormone replacement therapy
* Known allergy to lidocaine or other local anesthetic
* Positive stress test
* Active alcohol or substance abuse
Bioavailability Study of (Buspar) Buspirone HCl Tablets Under Fasting and Fed Conditions

To compare the single-dose bioavailability of Par and Bristol-Myers Squibb Buspirone HCl Tablets

To compare the single-dose bioavailability of Par and Bristol-Myers Squibb (Buspar) 15 mg buspirone HCl tablets, following administration of a 30 mg dose, under fed conditions. In addition, the bioavailability of the Par product was compared under fed and fasting conditions.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers, 18-45 years of age
* Weighing at least 60 kg, who are within 10% of their ideal weights (Table of "Desirable Weights of Adults", metropolitan Life Insurance Company, 1983)
* Physical examination and laboratory tests of hematologic, hepatic and renal functions.
* Medically healthy subjects with clinically normal laboratory profiles will be enrolled in the study

Exclusion Criteria:

* History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease.
* In addition, the presence of alcoholism or drug abuse within the past year: hypersensitivity or idiosyncratic reaction to buspirone HCl.
* Subjects who have been receiving monoamine oxidase inhibitors.
* Subjects who have been on an abnormal diet (for whatever reason) during the 28 days preceding the study.
* Subjects who, through completion of the study, would have donated in excess of 500 mL blood in 14 days, or 500-750 mL blood in 14 days (unless approved by the Principal Investigator, 1000 mL blood in 90 days, 1250 mL blood in 120 days, 1500 mL blood in 180 days, 2000 mL blood in 270 days, 2500 mL blood in 1 year.
* Subjects who have participated in another clinical trial with 28 days of study start.
Clinical Efficacy of Insulin Pumps in Type 1 Diabetes Mellitus Patients in Spain

Observational cross-sectional multicenter study about clinical efficacy of insulin pumps in type 1 diabetes mellitus patients.

Observational cross-sectional multicenter study about clinical efficacy of continuous subcutaneous insulin infusion in type 1 diabetes mellitus patients.

All clinical variables are gathered from the Spanish Insulin Pump National Registry.

Data analysis is conducted using SPSS (Chicago, IL) statistic software. Results are presented as mean +/- SD values. A paired Student's t-test or a Wilcoxon signed-rank test were used for the analysis of differences. Comparisons between proportions were analyzed using a chi-squared test. A P value \< 0.05 was considered statistically significant.

The protocol was approved by the reference Castilla-La Mancha Public Health Institute Ethic Committee. All participants provided written informed consent.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes patients treated with insulin pump.
* Medical treatment received in Spain.

Exclusion Criteria:

- Any other kinds of diabetes.
Pilot Clinical Performance of a Silicone Hydrogel Lens for Up to Six Nights of Extended Wear

The purpose of this clinical study is to evaluate the on-eye performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn continuously for up to 1 week.

Subjects will be randomized to wear the investigational contact lens in 1 eye and the commercially available contact lens in the other eye. Subjects will be expected to attend 3 scheduled study visits: Day 1 Screening/Baseline/Dispense; Day 2 Follow-up within 4 hours of awakening (after the first night of sleeping); and Week 1 Follow-up/Exit. The expected duration of exposure to each of the study lenses for all randomized, completed subjects was approximately 7 days / 6 nights of wear.

Eligibility Criteria:
Key Inclusion Criteria:

* Able to understand and sign an IRB/IEC approved Informed Consent form.
* Successful wear of spherical soft contact lenses in both eyes during the past 3 months for a minimum of 5 days/week and in an extended wear modality at least 1 night/week.
* Best corrected visual acuity of 20/25 or better in each eye.
* Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

* Any condition, use of medications, or surgery that could contraindicate contact lens wear, as determined by the Investigator.
* Any habitual wear of Biofinity contact lenses.
* Pregnant or breast-feeding.
* Other protocol specified exclusion criteria may apply.