cyrilzakka/clinical-trials huggingface dataset:
Evaluating the Effects of a Study Medication on Exercise Function in Type 2 Diabetes

People who are overweight or who have type 2 diabetes mellitus (T2DM) have higher levels of certain fats in their blood. The blood vessels and heart of most of these individuals do not work normally and people with T2DM also have an impaired ability to perform exercise. The purpose of this study is to use the free fatty acid lowering drug, acipimox, to temporarily decrease the level of fat in the bloodstream of people with T2DM and observe the physiological changes to blood vessel function and exercise capacity and insulin sensitivity. This will help the investigators to understand ways of improving blood vessel function and the ability to exercise effectively in people who are overweight or have T2DM.


Eligibility Criteria:
Inclusion Criteria:

* Sedentary adults not participating in a regular exercise program (≤ one bout of scheduled exercise per week)
* Subjects must have Type 2 Diabetes
* Subjects must be otherwise healthy
* Ages of 30-60 years
* BMI of 25-39 and stable weight for 3 months prior to the start of the study
* Diabetes controlled by diet +/- insulin secretagogues (sulfonylureas or glinides), metformin, or glucose absorption blockers (acarbose).
* Total glycosylated hemoglobin levels (HbA1C) ≤9% (fair control) on current therapy.

Exclusion Criteria:

* Any comorbid condition which could limit exercise performance including Chronic Obstructive Pulmonary Disease (COPD) or asthma
* Concurrent enrollment in an interventional study.
* Any tobacco use either current or within the last year
* Clinically evident distal symmetrical neuropathy, determined by evaluation of symptoms (numbness, paresthesia) and signs (elicited by vibration, pinprick, light touch, ankle jerks), will be excluded.
* Autonomic dysfunction (\>20 mm fall in upright BP without a change in heart rate) will be excluded.
* Evidence of ischemic heart disease by history or abnormal resting or exercise electrocardiogram (EKG) (\> 1 mm ST segment depression) on screening exercise test.
* Angina or any other cardiovascular, pulmonary or musculoskeletal symptoms
* Presence of systolic blood pressure \>190 at rest or \>250 with exercise or diastolic pressure \>95 at rest or \>105 with exercise
* Proteinuria (urine protein \>200 mg/dl) or a creatinine \> 2 mg/dl, suggestive of severe renal disease
* Proliferative retinopathy
* Insulin, incretin, or glitazone treatment
* Niacin treatment
* History of peptic ulcers
* A history of hereditary angioedema
* C1 esterase deficiency
* Women who are pregnant or breastfeeding
* Use of fibrate drugs
Persistent Atrial Fibrillation Cryoballoon Ablation

Patients with persistent irregular heartbeats also called persistent atrial fibrillation usually have a lower probability of curing their arrhythmia with ablation with heat called radiofrequency then those with paroxysmal atrial fibrillation, as previous studies have shown.

The emerging ablation with freeze(cryoablation) has not been studied for persistent atrial fibrillation but has been proven to be efficient in the paroxysmal type.

We hypothesized that persistent atrial fibrillation will have a freedom of recurrence rate of 70% after use of cryoablation at one year of follow up.

This was a retrospective single center cohort study designed to assess the freedom from recurrence of atrial fibrillation in the sample of patients with long persistent atrial fibrillation.

All patients who underwent cryoballoon ablation for atrial fibrillation at Staten Island University Hospital in the period ranging from January 2010 to 2013 were included in the study.

Data was collected from the electronic medical record as well as from the physician's office records after Institutional Review Board approval of the protocol

.Data collected included demographics, comorbidities pertaining to diabetes, heart failure, coronary artery disease, stroke occurrence, medications including antiarrhythmics and anticoagulants, procedural details including time of procedure and of fluoroscopy, vein ostial size, number of veins isolated, time to first recurrence after blanking period, complications of procedure and mortality. All patient identifiers were kept in a password protected computer.

Eligibility Criteria:
Inclusion Criteria:

* All patients included in the registry and who have symptomatic persistent atrial fibrillation presenting to the institution who favor ablation as first line therapy instead of antiarrhythmics
* All patients with symptomatic persistent atrial fibrillation who have failed antiarrhythmic therapy.

Exclusion Criteria:

* Patients refusing follow up by event monitor.
* Pregnant women.
The Safety and Efficacy of the Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Back Pain.

The objective of this study is to assess the safety of the buprenorphine transdermal system (5, 10, and 20) in comparison to placebo transdermal system and immediate release oxycodone/ acetaminophen in subjects with chronic back pain. The double-blind treatment intervention duration is 84 days during which time supplemental analgesic medication (non-steroidal anti-inflammatory drugs) will be allowed for all subjects in addition to study drug.

Buprenorphine is a synthetic opioid analgesic with over twenty-five years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.

Eligibility Criteria:
Inclusion Criteria:

* clinical evidence of stable, chronic (\>2 months) back pain related to intervertebral disc disease, nerve root entrapment, spondylolithesis, and osteoarthritis or other, similar nonmalignant conditions.
* unacceptable pain control despite currently taking a nonsteroidal anti-inflammatory drug considered at a therapeutic and/or tolerated dose or, subjects currently taking \</=2 short-acting opioid doses per day, or subjects taking 3-12 short-acting opioid doses per day.

Exclusion Criteria:

* receiving opioids at an average daily dose of \>90 mg of oral morphine equivalents or receiving more than 12 tablets per day of short-acting opioid-containing products.
* scheduled to have surgery (including dental) involving the use of preoperative or postoperative analgesics or anesthetics during the study period.

Other protocol-specific exclusion/inclusion criteria may apply.
Evaluation of Analgesia With EMLA and Glucose Oral Solution

In this randomized controlled study the investigators intended to compare analgesic effects of EMLA and/or oral glucose in 60 preterm neonate during arterial function and PICC installation.

It is a randomised controlled clinical trial, double blinded, with the purpose to compare the use of eutectic mixture of local anesthetics (lidocaine and prilocaine) and/or the oral solution of glucose 25% in the prevention and treatment of pain in preterm neonates with gestational between 28-37 weeks old.

The pain evaluation will be done using NIPS scale, and also physiologic variables (HR, MAP, oxygen saturation level and crie) during two painful procedures performed in the neonatal intensive care units:arterial puncture (n=30) and peripherally inserted central catheters (n=30). All procedures will have clinical indication and will not be implemented by the researcher.The newborns will be randomized into three groups: A (EMLA and glucose; n=20),B (EMLA AND placebo; n=20) and C (anesthetic cream placebo and oral glucose; n=20).

All newborns will be subjected to some kind of therapeutic intervention, the objective of this study is validate the application of control measures and treatment of pain for these two procedures that cause mild and moderate pain.

Eligibility Criteria:
Inclusion Criteria:

1. Gestational age greater than or equal to 28 weeks and less than 37 weeks
2. Admission in the neonatal intensive care unit of the hospital Julia Kubtischek
3. Clinical indication of collection of blood through arterial puncture or peripherally inserted central catheter
4. Neonate in the first week of life (first to seventh day of life);
5. Informed consent have to be obtained by parents or guardians.

Exclusion Criteria:

1. Newborn with broken skin at cream application site;
2. Use of sedation or analgesia in the last 72 hours;
3. Diagnosis of necrotizing enterocolitis;
4. Anemia
5. Metabolic acidosis
6. Methaemoglobinaemia
7. Treatment with agents to induce methemoglobinemia
8. Mechanical ventilation in patients using opioids
9. Clinical diagnosis of neuromuscular dysfunction
10. Any contraindication to suction
11. Urgent procedures
Perioperative Hypogonadism in Men Undergoing Radical Cystoprostatectomy for Bladder Cancer

The purpose of this study is to examine the relationship between testosterone level changes around the time of radical cystectomy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of bladder cancer
* Scheduled to undergo radical cystectomy

Exclusion Criteria:

* Evidence of advanced metastatic disease,
* Undergoing cystectomy for non-bladder primary malignancy or bladder cancer type other than urothelial cell
* History of breast or prostate cancer
* Polycythemia, cardiovascular thromboembolism, untreated obstructive sleep apnea, uncontrolled heart failure, or acute coronary event in the past six months
Noninvasive Cortical Neurostimulation For Diabetic Neuropathic Pain

To investigate whether transcranial direct current stimulation can alleviate pain and sensory related disturbances in individuals with type 1 diabetes and peripheral neuropathy through neuromodulation of the CNS as compared to sham treatment.

This study is a randomized, cross-over, controlled investigation. The overall objective of this study is to assess the pain-relieving effect of four weeks' transcranial direct current stimulation (tDCS) in individuals with type 1 diabetes and painful polyneuropathy not responding adequately to traditional pharmacological pain treatment, in comparison to the effect of four weeks' sham treatment. Both treatments will be performed using a commercially available and validated device called Sooma tDCS. Sooma tDCS device is a non-invasive neurostimulator that has been CE-marked for the treatment of depression, chronic pain including neuropathic pain and fibromyalgia. The study will begin with a 2-week baseline registration period, in which the patients will receive no treatment. Next, the baseline period will be followed by a 4-week treatment period where the subjects will be randomized to either active treatment or sham treatment. Afterwards, a wash-out period of 6 weeks will occur. Finally, in the second treatment period the patients will switch in treatment assignment, meaning that patient who received active treatment will now receive sham treatment and vice versa. During both treatments, the patients will be asked to self-administer one stimulation dose daily, five times a week. During the whole study, subjects will be asked to complete a pain diary and several questionnaires. Moreover, at the beginning and end of each treatment period (four times), all subjects will undergo testing which will include brain magnetic resonance imaging (MRI) and quantitative sensory testing (QST). The primary efficacy parameters to be evaluated are short and longer lasting alleviation of clinical chronic pain and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Minimum age of 18 years.
* Type-1 diabetes
* Clinically established peripheral neuropathy
* DN4 of ≥4 points indicating that the patient is suffering from neuropathic pain.
* NRS pain scores \>3
* Acceptable screening blood samples according to medical judgement
* Signed informed consent

Exclusion Criteria:

* Contraindications to MRI
* Not being able to understand Danish (written and/or verbally)
* Not being able to comply with the study procedures including home-treatment e.g., due to senile dementia, etc.
* Previous brain surgery
* Present alcohol or drug abuse
* Major mental and psychiatric disorders
* Pregnancy
* Active cancer-disease
* Known neural damage or disease in the neural system (e.g., MS or Guillain-Barre) other than diabetic neuropathy
* Previous chemotherapy or intake of experimental medicine
* Active herpes simplex virus or varicella zoster virus infection or known HIV
* Other reasons for limb pain (e.g., critical limb ischemia and lower back pain with radiating pain etc.)
A Study to Understand the Long-term Safety and Effects of an Experimental Gene Therapy for Duchenne Muscular Dystrophy.

The purpose of this study is to understand the safety and effects of an experimental gene therapy called fordadistrogene movaparvovec. We are seeking participants from previous Pfizer interventional studies. We will follow participants' experience in this study for 10 years after the end of their previous study. Participants will have 1 annual onsite visit and a few annual remote visits. The exact number of remote visits will be decided by their study doctor.


Eligibility Criteria:
Inclusion Criteria:

* Participants who received fordadistrogene movaparvovec in a previous Pfizer interventional study.

Exclusion Criteria:

* Investigator site staff directly involved in the study and their family members
Pain and Fatigue Study

Patients with advanced cancer who are undergoing chemotherapy and who report pain and fatigue at intake in the past 24 hours or at a level 2 or higher of pain or fatigue at a 3 or higher on a 10-point scale will be assigned randomly to an 8-week, 6-contact self management attention control (SMAC) intervention, or to a 8-week, 6-contact experimental patient intervention for management of symptoms and support (PIMSS) targeted toward symptom management, reducing impact on physical role and social functioning and emotional distress. Both groups will continue to receive conventional cancer care.

When compared with the self-management attention control intervention, patients exposed to the experimental intervention will report statistically significant positive effects on the following:

1. The primary outcome--total number of symptoms reported;
2. The secondary patient outcomes--reduced deterioration in physical role impact and social functioning, emotional distress, levels of communication with caregiver about care, and communication and satisfaction with provider care; and
3. Caregiver outcomes--greater involvement in symptom management, increased mastery of the caregiving process, reduced levels of depression and burden.

GOAL: The primary goal of this research is to test a symptom management intervention, delivered by nurses with special training, using a stepped-care approach targeted toward pain and fatigue, followed by fifteen other prevalent cancer symptoms. Second goals are to improve physical and social functioning, lower emotional distress, and improve communication with family caregiver in symptom management, and assist them to reduce their levels of depression and burden. This research is funded through a grant from the National Cancer Institutes, and builds upon the Family Care Research Team's program of supportive cancer-care research.

OUTCOMES: This study tests a stepped-approach intervention to determine if it improves symptom outcomes, especially pain and fatigue. Secondary outcomes addressed by the intervention are physical role impact, social functioning, and emotional distress. These outcomes can have significant impact on patients and family caregivers' well-being as patients undergo chemotherapy. The shorter, more intense intervention corresponds to changes int he clinical management of cancer patient with more intense, shorter chemotherapy treatments; therefore, this intervention will be more easily translatable to the clinical setting.

Eligibility Criteria:
Inclusion Criteria:

* 21 years of age or older
* solid tumor cancer diagnosis
* receiving chemotherapy treatment
* advanced cancer
* family caregiver

Exclusion Criteria

* Emotional or psychology disorder for which patient is receiving treatment
* does not speak English
* does not have access to a telephone
* difficulty hearing on the telephone
Exercise-regulated Organ Crosstalk, Influence of IL-6

Overall the study investigates organ crosstalk during exercise. More specifically, the study investigates the role of IL-6 in regulating glucose, fatty acid, and amino acid kinetics at whole body level and in skeletal muscle, liver, and brain. Furthermore, the study investigates the uptake and release of extracellular vesicles in skeletal muscle, liver, and brain in reponse to exercise.


Eligibility Criteria:
Inclusion Criteria:

* Minimum age: 18 years
* Maximum age: 45 years
* Minimum BMI: 18
* Maximum BMI: 25
* Sex: Male
* Healthy (based on screening)
* Stable body weight for 6 months
* VO2max (mL/kg/min) ≥ 50

Exclusion Criteria:

* Smoking
* Thyroid disease
* Heart disease
* Inflammatory diseases
* Current infection
* Liver disease (transaminases more than 2x upper normal range)
* Kidney disease (creatinine more than1.5 mg/dl)
* Known immunosuppressive disease
* Corticosteroid use
* Regular NSAID or paracetamol usage
* Aspirin use more than 100 mg/d
* History of carcinoma
* History of tuberculosis
* Anemia (hematocrit less than 33%)
* WBC less than 1 x 10\^3
* Platelets less than 100 x 10\^3
* Bleeding disorders
* Obstructive pulmonary disease
* Femoral hernia
* Vascular prosthesis
* Vascular thrombosis
* Previous nerve damage
* Many previous femoral catheter installations
Evaluation of the Contribution of Low-pressure Intra-abdominal Insufflation for Laparoscopic Colic Resection

The laparoscopic surgery requires gas insufflation in the peritoneal cavity and the operator chooses the intraabdominal insufflation pressure. In general, during a conventional laparoscopy, this pressure is 12 to 15 mmHg. The reduction of the intra-abdominal pressure minimizes the parietal trauma due to the insufflation and could lead to a reduction of the postoperative pains and could allow an earlier recovery. In this study, the investigator propose to evaluate the benefits of a low pressure insufflation (6-8 mmHg) with pressure-controlled insufflator in patients with a mild or malignant colon pathology requiring surgical colic resection. The main objective of the study is to demonstrate that the laparoscopic colic resection at low pressure reduces the theoretical hospital stay of one day compared to the conventional laparoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Colic lesion justifying surgical resection by segmental colectomy,
* Surgery proposed by laparoscopy,
* Body mass index (BMI) ≤30 kg/m2,
* Written informed consent signed by the patient,
* Patient affiliated to the national French statutory healthcare insurance, system or beneficiary of this regimen.

Exclusion Criteria:

* Probable realization of a stoma during the procedure,
* Robot-assisted approach,
* Contraindication to laparoscopic surgery,
* Pregnant or likely to be pregnant,
* Patient deprived of liberty or placed under the authority of a tutor,
* Patient considered geographically socially or psychologically unable to comply with the study procedure and the medical follow-up.
Efficacy of a Mix of Probiotics in Athletes Performance

Monocentric Crossover Study to Assess the Tolerability and the Efficacy of a Mix of Probiotic Strains Doses vs Placebo in Athletes Performance

This study will intend:

- To assess the tolerability and the efficacy of a food supplements into improving performance in a panel of athletes after repeated use for 4 consecutive weeks, under the normal conditions of use, compared to a placebo.

The present study aimed at assessing the tolerability and the efficacy of a food supplements probiotics-based (L. acidophilus FB0012, L. plantarum FB0015, and L. rhamnosus FB0047 encapsulated in acid-resistant capsules) into improving performance in a panel of athletes after repeated use for 4 consecutive weeks, under the normal conditions of use, compared to a placebo.

Eligibility Criteria:
Inclusion Criteria:

1. Male and Female athletes18-45 years old (included).
2. Subjects accepting to follow the instruction received by the investigator and disposable and able to return to the study centre at the established times.
3. Subjects accepting to not receive any drugs/cosmetics treatment able to interfere with the study results.
4. No participation in a similar study actually or during the previous 6 months.
5. Subjects accepting to sign the Informed consent form.

Exclusion Criteria:

* 1. Known sensitivity to any compound of the Investigational product. 2. Pregnant or breast feeding females or planning a pregnancy. 3. Serious intercurrent infection or other active disease up to three months prior to study entry.

  4. History of concurrent malignancy. 5. History of significant alcohol or drug abuse. 6. Significant psycho-social or psychiatric disorders that may impair the subject's ability to meet the study requirements.

  7. Significant concurrent medical disorders that may impair the subject's ability to participate over the whole one year of the study.

  8. Any other medical condition which in the Investigator's opinion would prevent the subject from participating in the study.
Tolerability and Safety of 30, 45, and 60 mg of Sublingual Lobeline. - 1

The purpose of this study is to assess safety and pharmacokinetics of sublingual lobeline in healthy normal volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Must be able to provide written informed consent
* Must have a body mass index between 18 and 30
* Have no medical contraindications as determined by medical history, physical exam, ECG, hematology and blood chemistry profile, and urinalysis
* Must have a negative drug test at screening and admission
* If female of child bearing potential, must agree to use birth control

Exclusion Criteria:

* Please contact the site for more information
Quality of Postoperative Pain Management in Cardiac Surgical Patients

The purpose of this study is to determine the incidence and risk factors of moderate to severe pain after cardiac surgery, and compare the preoperative pain expectation and postoperative pain experience in the same patient.

Objectives

1. To study the incidence of moderate to severe pain in cardiac surgical patients 48 hour postoperatively.
2. To study the risk factors of moderate to severe postoperative pain in cardiac surgical patients.
3. To compare the preoperative pain expectation and postoperative pain experience in the same patient.

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for cardiac surgery in Siriraj Hospital
* age \> 18

Exclusion Criteria:

* unable to communicate with the patient