cyrilzakka/clinical-trials huggingface dataset:
Pain Discomfort Enjoyment Levels During Moderate Exercise

In order to better understand how pre-existing pain and also discomfort/enjoyment during exercise may influence physical activity and be related to body weight the investigators are seeking to examine these as they relate to overweight/obesity compared to normal weight individuals. Ultimately, the investigators think that people with obesity may have more and be more sensitive to pain and have lower discomfort tolerance that may lead them to experience exercise more negatively. In the real world, this could result in them stopping exercise sooner or avoiding exercise all together. Therefore it is important for the investigators to begin to understand this issue better. In addition, some preliminary studies in animals suggest that the quality of the diet may influence pain sensitivity. This has yet to be examined in humans. As such the investigators will examine whether self-reported diet quality and also some markers in participants' blood that can tell the investigators about the recent quality of a person's diet, are related to the measures of pain, enjoyment and discomfort during exercise.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-60 years.
* BMI ≥ 18.5 kg/m2.
* Typically exercise (moderate-intensity aerobic exercise - e.g. brisk walking) less than 150 minutes per week (last 3 months)
* No known contraindications for participating in up to 42 minutes of moderate intensity physical activity.
* Have not been told by a qualified healthcare provider to avoid moderate physical activity.

Exclusion Criteria:

* Unable/unwilling to provide informed consent.
* Having motor impairment.
* Currently diagnosed with diabetes mellitus, experiencing uncontrolled hypertension (i.e. systolic blood pressure (SBP) \> 140 mmHg or diastolic blood pressure (DBP) \> 90 mmHg), having a history of ischemic heart disease, cerebrovascular accidents, neurological disease or current/past severe psychiatric illness (e.g. severe depression, psychosis, schizophrenia) that required hospitalization, severe current untreated depression (i.e. score in the severe depression range on the Hospital Anxiety and Depression Scale; HADS), current suicidal ideation, and current or past suicide attempts.
* Women who are pregnant or nursing.
* Diagnosed history of eating disorders such as bulimia nervosa, anorexia nervosa.
* Diagnosed history of substance abuse or alcohol abuse.
* Currently undergoing pain management treatment (pharmacologic and or behavioral).
* Currently taking anti-depressant medicines
* Have been instructed by a qualified healthcare provider to refrain from moderate physical activity at any time during the last 12 months (reasons other than minor orthopedic injury etc.).
* Any implanted medical devices (e.g. pacemaker).
* Currently smoking (within last 12 months).
Prevalence of Atrial Delay That Would Preclude Optimization of Atrioventricular (AV) Delay in Patients With Biventricular (BiV) Device

The purpose of this study is to determine the proportion of patients who are undergoing Biventricular (BiV) Implantable Cardioverter Defibrillator (ICD) implantation in whom optimization of atrioventricular (AV) delay is not possible due to prolonged inter-atrial/intra-atrial delay. These patients would benefit from left atrial pacing, and if a significant number of patients fall into this group, it may be beneficial to develop a left atrial lead.

This is a prospective observational study. Patients referred for BiV-ICD implantation or upgrade will be implanted as is routinely done, with the following modifications:

* Electrical readings will be taken at various points in the procedure.
* The RA lead will temporarily be placed on the atrial septum for these readings (normally it is actively fixed to the RA appendage wall). The final RA lead position will be actively fixed to the RA appendage wall as is standard practice.
* The CS lead will be placed in the proximal coronary sinus for these readings prior to passing it distally to pace the LV.
* Patients will undergo transthoracic echocardiography (TTE) 30 days post-procedure. This will be coordinated to coincide with their standard 30-day follow-up appointment.

Conduction times between the left atrium and right atrium (inter-atrial conduction time) will be measured at the time of implant, and left atrial contraction time will be measured by TTE at the follow-up appointment. For patients in whom the inter-atrial conduction time plus the left atrial contraction time is greater than the right-atrial to right-ventricular conduction time, it is not possible to optimize the AV delay. The proportion of patients who fall into this group will be the main endpoint of the study. Patients will be followed for this study until their follow-up appointment and TTE at 30 days post-implant. The total sample size of this study will be 50 patients. We expect to consent approximately 75 patients, expecting that 1/3 will not meet all entrance criteria or will withdraw early.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Have the ability to provide informed consent and willingness to comply with follow-up tests
* QRS duration \> 120 ms
* Ejection fraction \< 35%
* Persistent symptoms of class III or IV heart failure despite a stable and optimized medical regimen
* Normal sinus rhythm or sinus bradycardia

Exclusion Criteria:

* White-Parkinson-White syndrome
* Chronic persistent atrial fibrillation
* Complete heart block
Substance Dependence Satisfaction With Care and Quality Of Life

The SUBUSQOL cohort aimed to improve knowledge of the quality of ambulatory care, in particular the prognostic role of the early satisfaction with care on the change from baseline quality of self-reported health status in outpatients with alcohol or opioid dependence. It is a multicenter prospective cohort. Satisfaction was assessed using a multidimensional self-administered and validated questionnaire during the early care process. In addition to measuring satisfaction and obtaining sociodemographic and clinical data, this study collected data on the self-reported health status at inclusion and 3, 6 and 12 months after inclusion.

Early satisfaction with care was measured using the quality of care satisfaction questionnaire in outpatient consultation (EQS-C). Data collected during the study included patient sociodemographic, clinical and health status characteristics, as well as physician characteristics. Self-perceived quality of life was assessed using the generic SF-12 and a specific questionnaire in illness disease, the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF).

Eligibility Criteria:
Inclusion Criteria:

* Outpatients who met the Diagnostic and Statistical Manual, fourth edition (DSM-IV) criteria for alcohol dependence, opioid dependence, or both.
* Patients recruited from the French specialized addiction treatment centers where they began care.
* Patient agreement obtained

Exclusion Criteria:

* Age lower than 18 years
* Inability to complete self-questionnaires
Exercise and Insulin Signaling in Human Skeletal Muscle

Obesity is associated with a decrease in skeletal muscle insulin sensitivity. Aerobic exercise can increase insulin sensitivity in the few hours following exercise, however the cellular mechanisms are not completely understood. The current project is to investigate mechanisms of exercise improvements to skeletal muscle insulin sensitivity.

Study Overview: We are investigating the mechanisms by which exercise improves the response of skeletal muscle to insulin in lean and obese adults. Participants will complete 4 study visits consisting of: 1) screening visit, 2) maximal exercise test visit, and then a randomized order of 3) a resting metabolic study visit, and 4) an exercise metabolic study visit. Metabolic study visits for resting and exercise conditions will be identical, other than remaining sedentary or performing exercise. Skeletal muscle biopsy samples will be collected during resting, immediately post-exercise and during insulin stimulated conditions.

Eligibility Criteria:
Inclusion Criteria:

* Males or Females
* Aged 18-45 years
* Normal weight (body mass index \[BMI\] 18-26 kg/m2) or obese (BMI 30-46 kg/m2)
* Sedentary (\< 1 hour of planned physical activity per week for ≥ 6 months)
* Weight stable (\< 2 kg change in body mass for ≥ 6 months)
* Non-smokers (no tobacco or nicotine use for ≥ 1 year)

Exclusion Criteria:

* Hypertension (systolic blood pressure \>140 mmHg, diastolic blood pressure \> 90mmHg)
* Chronic health condition including diabetes, cardiovascular disease, treated hypertension, cancer, anemia, uncontrolled hyper- or hypothyroidism.
* Pregnant, nursing, irregular menses or post-menopausal (if female)
* Hyperglycemia (fasting glucose \>126 mg/dl)
* Hypercholesterolemia (fasting LDL\>140mg/dl)
* Hemoglobin \< 13.0 g/dl (males), \< 11.5 g/dl (females)
* Compromised renal function (outside 135-145 mmol/L sodium, 3.5-5.1 mmol/L potassium)
* Lidocaine allergy
* Medications including β-blockers, angiotensin converting enzyme inhibitors, insulin, thiazolidinediones, metformin, sulfonylureas, chronic non-steroidal anti-inflammatory use, anti-coagulant (e.g. warfarin), current antibiotics, opiates, monoamine oxidase inhibitors, benzodiazepines, or others that may impact the study outcomes
* Any physical limitation that prevents a participant from safely completing the exercise test
* Due to the risks associated with the current protocol, individuals with a diminished capacity to consent will be excluded. Similarly, due to the need for constant, accurate participant monitoring during metabolic study activities, participants will need to clearly understand verbal and written English. Participants who cannot clearly understand verbal and written English will be excluded.
Pilot Study of the Safety and Efficacy of Anakinra in Pulmonary Arterial Hypertension

Pulmonary arterial hypertension (PAH) can result in right ventricular failure and death. Anakinra has been used in patients with left sided heart failure, and the present study looks to determine if anakinra is safe and effective in patients with PAH. To accomplish this goal, we plan to evaluate for exercise improvement (as assessed by cardiopulmonary exercise testing) in 10 patients with PAH on anakinra.

Patients with pulmonary arterial hypertension will undergo cardiopulmonary exercise testing (CPET) at baseline and at 2 weeks. After the initial CPET, all patients will receive anakinra as a daily injection for 2 weeks. Patients will be instructed in the use of anakinra during their initial visit. Our primary outcome will be the difference in the exercise capacity of patients with PAH, as measured by maximal uptake of oxygen on CPET.

Eligibility Criteria:
Inclusion Criteria:

* age over 18
* functional class II or III symptoms of right ventricular failure despite optimal PAH therapy
* mean pulmonary artery pressure \>25mmHg on previous right heart catheterization
* pulmonary arterial wedge pressure \<15mmHg on previous right heart catheterization
* pulmonary vascular resistance \>3 wood units on previous right heart catheterization

Exclusion Criteria:

* PAH due to connective tissue disease
* angina or electrocardiograph changes that limit maximum exertion during cardiopulmonary exercise testing or baseline EKG changes that limit the ability to detect ischemia
* recent (\<14 days) use of anti-inflammatory drugs (not including NSAIDs), chronic inflammatory disorder, malignancy, active infection, or any comorbidity limiting survival or ability to complete the study
* sever kidney dysfunction (eGFR \<30mL/min)
* thrombocytopenia (\<50,000/mm3), or neutropenia (absolute neutrophil count \<1500/mm3)
* refusal by a woman of childbearing potential to use a medically acceptable form of birth control
* history of hypersensitivity to anakinra or E. coli products
* latex or rubber allergy
* inability to give informed consent
* non-English speaking
A Study of Efavirenz in Combination With Stavudine and Didanosine

The purpose of this study is to see if it is safe and effective to give efavirenz plus stavudine plus didanosine to HIV-infected patients who have never received anti-HIV treatment.

Patients will be given combination treatment with efavirenz, stavudine, and didanosine.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Documented HIV infection with plasma HIV-RNA greater than or equal to 10,000 copies/ml.
* A life expectancy of at least 12 months.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Current bilateral peripheral neuropathy greater than or equal to Grade 2.
* Any clinically significant laboratory findings obtained during the screening evaluation (see laboratory values).
* Any clinically significant disease (other than HIV infection) or clinically significant findings during screening of medical history or physical examination.
* Any malignancy that requires systemic therapy.
* Proven or suspected acute hepatitis due to any cause.
* Recurrent episodes of moderate to severe diarrhea, or vomiting lasting more than 4 days within 3 months prior to dosing.
* Active AIDS-defining opportunistic infection or disease.

Concurrent Medication:

Excluded:

Astemizole, cisapride, clarithromycin, ketoconazole, itraconazole, midazolam, rifabutin, rifampin, terfenadine, thalidomide, triazolam, vincristine, zalcitabine.

Patients with the following prior conditions are excluded:

* History of acute or chronic pancreatitis.
* Life expectancy less than 12 months.
* Difficulty in swallowing capsules/tablets.
* Hypersensitivity to any component of the formulation of efavirenz, stavudine, or didanosine.

Prior Medication:

Excluded:

* Any other experimental drug within 30 days of introducing study treatment.
* Vaccination within 3 weeks of screening visit.
* Interferon started within 30 days of initiating study treatment.
* Prior antiretroviral therapy.

Risk Behavior:

Excluded:

- Current alcohol or illicit drug use which would interfere with compliance with dosing schedule and protocol evaluations.
Efficacy of Opioid-free Anesthesia in Reducing Postoperative Respiratory Depression in Children Undergoing Tonsillectomy

The objective of this trial is to determine whether an opioid-free general anesthetic (OFA) technique utilizing ketamine, dexmedetomidine, lidocaine, and gabapentin can help reduce postoperative respiratory depression in the post-anesthesia care unit and ward in children with sleep-disordered breathing undergoing tonsillectomy when compared with traditional opioid-containing techniques. It is expected that this OFA regimen will have a measurable reduction on postoperative respiratory depression in children with sleep-disordered breathing.

The objective of this trial is to determine whether an opioid-free general anesthetic can help reduce postoperative respiratory depression in the post-anesthesia care unit and ward in children with sleep-disordered breathing undergoing tonsillectomy when compared with traditional opioid-containing techniques.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 0-12 years with Sleep Disordered Breathing (SDB) who are scheduled for elective Tonsillectomy/AdenoTonsillectomy (T/AT) will be recruited at Royal University Hospital, Saskatoon, Saskatchewan.

Exclusion Criteria:

* age \> 12; American Society of Anesthesiologists (ASA) Classification \> IV; significant cardiorespiratory, neurological, craniofacial, hepatic, renal, or genetic disorders, excluding SDB; concomitant surgical procedures other than myringotomy and tubes; and allergy to any of the study drugs
Sudden Hearing Loss Multi-center Clinical Trial

The incidence of sudden hearing loss is rising obviously resent year, Glucocorticoids have obtained obvious effect in the treatment of sudden deafness. Postauricular hypodermic injection is the latest findings in clinical work and a new noninvasive way of administration which is gradually expanding research. The aim of this experiment is to verify and explore the efficacy and safety of the postauricular injection treatment with different doses of Glucocorticoids.


Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years, less than 60 years old;
* patient with unilateral or bilateral（occured successively) acute sensorineural hearing loss(ASNHL) with onset 72hours or less ago. Mean hearing loss compared with the unaffected contralateral ear of at leat 60 dB;
* Primary presentation within 2weeks; standard treatment for 2 weeks;
* After 2weeks of standard treatment, sensorineural hearing loss (SHL) curative effect evaluation damaged frequencies \>/=30 dB better than before;
* Written informed consent before participation in the study.

Exclusion Criteria:

SYSTEMIC DISEASE

* History of tuberculosis or positive purified protein derivative (PPD);
* Insulin-dependent diabetes mellitus;
* Hypertension, poor control of BP(SBP/DBP)\>=140mmHg);
* History of rheumatic disease, e.g. rheumatoid arthritis, scleroderma, lupus, etc;
* Serious psychiatric disease or psychiatric reaction to corticosteroids;
* History of heart disease or transient ischemic attacks(TIAs);
* Prior treatment with chemotherapeutic or immunosuppressive drugs;
* Pancreatitis;
* Active peptic ulcer disease or history of gastrointestinal bleeding;
* History of HIV, Hepatitis B or C;
* Chronic kidney failure;
* Alcohol abuse;
* Active shingles;
* Severe osteoporosis or non-surgical aseptic necrosis of the hip;
* Without contraindication with glucocorticoid, ginaton, Batroxobin.

OTOLOGIC DISEASE

* History of Meniere's disease;
* History of chronic ear infection;
* Prior history of sudden sensorineural hearing loss (SSNHL);
* History of fluctuating hearing loss.
Interaction of Potassium and Genetic Risk Variants on Diabetes Risk

The investigators propose to study the association of the KCNJ11 (Potassium Voltage-Gated Channel Subfamily J Member 11) polymorphisms on diabetes risk in the Atherosclerosis Risk in Communities (ARIC) and Jackson Heart Study (JHS) cohorts. The investigators also propose to test for an interaction between serum K and these genetic variants. By testing for such an interaction, it will be determined if, among participants with these genetic variants, a low-normal serum K was a stronger predictor of diabetes risk compared to those participants without these genetic variants.


Eligibility Criteria:
Inclusion Criteria:

* Member of the Atherosclerosis Risk in Communities (ARIC) Study or Jackson Heart Study (JHS) cohorts

Exclusion Criteria:

* Had not fasted 8 or more hours for the baseline visit
* Prevalent diabetes at baseline exam
* Missing information on serum potassium
* Missing single nucleotide polymorphism (SNP) data
* Evidence of kidney dysfunction
* Race other than black/African American or white/Caucasian
* Missing other covariates
Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in Canada

The interferon-free combination regimen of ombitasvir/paritaprevir/ritonavir/ with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC) has been shown to be safe and effective in randomized controlled clinical trials with strict inclusion and exclusion criteria under well-controlled conditions. This observational study was the first effectiveness research examining the ABBVIE REGIMEN ± RBV, used according to local label, under real world conditions in Canada in a clinical practice patient population.

This was a prospective, multi-center observational study in participants receiving the interferon-free ABBVIE REGIMEN ± RBV in Canada. The prescription of a treatment regimen was at the discretion of the physician in accordance with local clinical practice and label, was made independently from this observational study and preceded the decision to offer the participant the opportunity to participate in this study. Adults chronically infected with HCV, receiving the interferon-free ABBVIE REGIMEN, were offered the opportunity to participate in this study during a routine clinical visit at the participating sites. Follow-up visits, treatment, procedures, and diagnostic methods followed physicians' routine clinical practice. Data were collected at the following time windows: baseline, early on-treatment visit, mid-treatment visit (for participants with a treatment duration of 24 weeks), end of treatment (EoT), early post-treatment and 12 and 24 weeks after the end of treatment (representing sustained virologic response 12 weeks after the end of treatment \[SVR12\] and sustained virologic response 24 weeks after the end of treatment \[SVR24\]).

Eligibility Criteria:
Inclusion Criteria:

* Treatment-naïve or -experienced adult male or female participants with confirmed chronic hepatitis C (CHC), genotype 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± ribavirin (RBV) according to standard of care and in line with the current local label
* If RBV was co-administered with the ABBVIE REGIMEN, it had to be prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy)
* Participants had to voluntarily sign and date an informed consent form prior to inclusion into the study
* Participants must not have participated or intended to participate in a concurrent interventional therapeutic trial

Exclusion Criteria:

* None
Emotion Regulation Intervention to Sustain Physical Activity in Rural-dwelling Women and Men After Myocardial Infarction

The purpose of this study is to evaluate early preliminary efficacy of the eMotion intervention in US adults who have experienced a first cardiac event and participating in phase II cardiac rehabilitation.

This study will evaluate early efficacy and evaluate the cognitive processes as intervention response variables. Investigators will also examine the relationships between emotion regulation and other cognitive processes and symptoms (threat and stress, cognition and motivation), symptoms \[depression, anxiety, pain, sleep, and fatigue\]), and health related quality of life among adults enrolled in cardiac rehabilitation after a first cardiac event.

Aim 1: Evaluate early preliminary efficacy of the eMotion intervention

Research hypothesis 1. Compared with adults randomized to active healthy living attention control and usual care control groups, adults randomized to eMotion will have greater improvement in these outcomes over time:

1.1. Improved minutes of moderate to vigorous physical activity 1.2. Symptom improvement (depression, anxiety, pain, sleep, and fatigue) 1.3. Health related quality of life.

Aim 2: Evaluate the cognitive processes as intervention response variables.

Research hypothesis 2. Compared with adults randomized to active healthy living attention control and usual care control groups, adults randomized to eMotion will have:

2.1. Improved emotion regulation (efficiency and strategy use) 2.2. Decreased perceived cardiac threat and general stress 2.3. Improved cognition and motivation

Aim 3. Exploratory. Examine the relationships between emotion regulation and other cognitive processes and symptoms (threat and stress, cognition and motivation), and symptoms \[depression, anxiety, pain, sleep, and fatigue\]) among adults enrolled in cardiac rehabilitation after a first major cardiac event.

Eligibility Criteria:
Inclusion Criteria:

1. First time major cardiac event as documented in medical record;
2. enrolled in cardiac rehabilitation phase II program;
3. living independently; and
4. at least mild symptoms of depression and/or anxiety (determined by standardized measure cutpoints).

Exclusion criteria:

1. does not speak English;
2. major Axis 1 psychiatric diagnosis (e.g. schizophrenia);
3. terminal cancer; and
4. legally blind