cyrilzakka/clinical-trials huggingface dataset:
Use of Local Anesthetic (0.25% Bupivacaine) for Pain Control in Pediatric Cardiac Catheterization

In the Cardiac Diagnostic and Interventional Unit (CDIU) at the Hospital for Sick Children (SickKids), minimally invasive procedures are performed to diagnose and treat a variety of congenital heart defects. Procedures are performed under general anesthetic and involve inserting a catheter through the skin and into the femoral vein or artery in the groin. In addition, the use of local anesthetic as a pain control regimen just prior to the removal of femoral artery or vein sheaths is used by some but not all cardiac interventionalists. Local anesthetic is infiltrated near the sheath insertion site, at the end of the procedure while the child is under general anesthetic, with the goal of decreasing pain at the insertion site and promoting comfort in the post-operative period. The use of local anesthetic depends on the choice of the individual practitioner and is not currently a routine practice for all patients.

The investigators proposed research seeks to investigate whether the use of subcutaneous bupivacaine reduces pain levels in the post-operative period in children having cardiac catheterization procedures.

A number of differences in pediatric cardiac catheterization procedures exist that limit the transferability of research findings from the adult literature. For example, the majority of pediatric cardiac catheterizations are performed under general anesthetic, and femoral sheaths are removed while under general anesthetic and at the end of the procedure. In contrast in adult clinical practice, procedures are not performed under general anesthetic, and femoral sheaths are removed when patients are awake and often 4 to 6 hours after the end of the procedure. These differences limit the ability to apply research findings in adults to pediatrics, warranting further study of the effects of local anesthetic on femoral site pain in children. As well, studies in adults have examined pain only up to 20 minutes after sheath removal. We seek to investigate the impact of bupivacaine up to 6 hours after cardiac catheterization in children.

Eligibility Criteria:
Inclusion Criteria:

1. Ages 7-18 years
2. Scheduled for cardiac catheterization through the femoral artery and/or vein under general anesthetic
3. Ability to speak and understand English
4. No apparent cognitive impairments

Exclusion Criteria:

1. Known allergies to bupivacaine
2. Impaired renal function
3. Impaired hepatic function
Single Dose of Lu AF28996 to Healthy Young Men

This study evaluates how increasing doses of Lu AF28996 enters, moves through and exits the body when given by mouth to healthy young men.

Part A of the study consists of 6 groups (Cohorts 1 to 6) with 3 subjects in each, with the possibility of 4 additional cohorts. In cohort 1, the subjects will receive a single dose of Lu AF28996 by mouth. Following evaluation of data from the first dose, the subjects in the following cohorts are planned to receive two single increasing doses by mouth of Lu AF28996 on 2 separate days with a wash out (day or days without dosing) in between.

Part B is an open-label three-period crossover study in healthy young men to compare the PK of an oral capsule formulation with that of an oral solution formulation and to evaluate food effect following oral capsule administration of Lu AF28996.The subjects will be randomised to one of the four treatment sequences

Eligibility Criteria:
Inclusion Criterium:

Healthy, young, non-smoking men aged ≥18 and ≤45 years and with a body mass index (BMI) ≥18.5kg/m2 and ≤30kg/m2 at the Screening Visit

Other in- and exclusion criteria may apply
Gut Microbiota, Mitochondrial Function and Metabolic Health in Obesity

It has been suggested that individuals with the condition known as metabolically healthy obesity (MHO) may not have the same increased risk of developing metabolic abnormalities as their non-metabolically healthy counterparts. In addition, to date, the identification of metabolic biomarkers and microbiota underlying the MHO state is limited. In this study, our goal is to provide insight into the underlying metabolic pathways affected by obesity. To achieve this, we will compare the metabolic profile, inflammatory parameters and mitochondrial function, as well as metabolomic analysis and differential expression of microbiota in obese patients categorized as metabolically healthy vs. non healthy. In parallel, the effect of a hypocaloric diet on obese subjects' metabolism and microbiota will be assessed to approve their use in the treatment of said disorder. Specifically, we propose an observational, clinical-basic, comparative and interventional study in a population of 80 obese (BMI\>35 kg/m2) patients clustered in two groups according to the presence or absence of altered metabolism (altered fasting glycemia, hypertension, atherogenic dyslipidemia). Anthropometric and clinical variables and biological samples (serum, plasma, peripheral blood cells and feces) will be collected for the determination of biochemical parameters (glucose, lipid and hormonal profile by enzymatic techniques) and protein-based peripheral biomarkers of mitochondrial function \[total and mitochondrial reactive oxygen species (ROS) production, mitochondrial membrane potential, glutathione levels by static cytometry\], markers of mitochondrial dynamics \[Mitofusin 1 (MFN1), Mitofusin 2 (MFN2), Mitochondrial fision protein 1 (FIS1) and Dynamin-related protein 1 (DRP1) by RT-PCR and Western Blot\], markers of inflammation \[Interleukin 6 (IL6), Tumoral necrosis factor alpha (TNFα), IL1b, adiponectin, resistin, plasminogen activator inhibitor 1 (PAI-1), Monocyte chemoattractant protein-1 (MCP-1), caspase 1 and NLRP3 by Western Blot and technology XMAP), metabolomic assay (NMR spectroscopy and PLS-DA), as well as gut microbiota content and diversity (16S rRNA, MiSeq sequencing). Finally, we will evaluate the effect of a dietary weight loss intervention on these biomarkers.


Eligibility Criteria:
Inclusion Criteria:

* Patients with BMI≥30kg/m2, with at least 5 years of diagnosed obesity evolution.
* Patients have had stable body weight (±2 kg) during the 3 months prior to the study.

Exclusion Criteria:

* All patients with acute or chronic inflammatory diseases, neoplasic disease, secondary causes of obesity (uncontrolled hypothyroidism, Cushing's syndrome), and established liver and kidney failure (according to transaminase levels ±2 SD of the mean and estimated glomerular filtration rate using the CKD-EPI formula \>60) will be excluded.
COVID-19 Survey Study on Dietary Intake, Physical Activity and Overall Well-being

The aim of this research is to collect dietary intake, physical activity, mood and stress data during and after the Illinois shelter-in-place and social distancing orders for the COVID-19 pandemic. The study's intent is to capture data during this unprecedented time to understand the non-infection consequences of social distancing and shelter-in-place, including duration of affect after orders are lifted.

The proposed study is an observational study. The study will include our previous subjects, those who are following the shelter- in- place order due to the COVID-19 pandemic. Demographic data of individuals participating in the study will be recorded. During this 12-month protocol, participants will be contacted through email to complete online questionnaires on weekly basis for 8 weeks, and then once every 4 weeks until the end of the study. Subjects will record their one-day food intake, physical activity, sleep, and stress and anxiety level, which takes \~1 hour to complete.

Subjects will be recruited through our CNRC databases of individuals who come to our clinic in the past 1 year, online advertisement, and word of mouth. A phone and/or email will be administered to ensure their eligibility using our standard tools and protocols. People who are willing and able to participate and meet the basic screening eligibility will be contacted through email for informed consent and the continuing of the study.

Eligibility Criteria:
Inclusion Criteria:

* Able to provide informed consent
* Able to comply and perform the procedures requested by the protocol

Exclusion Criteria:

* N/A
Efficacy of Midodrine for the Prevention of Orthostatic Hypotension During Early Mobilization After Fast-track Hip Arthroplasty

The aim of this study is to examine the efficacy of 5 mg Midodrine (Gutron) vs. placebo on reducing the incidence of orthostatic hypotension during mobilization 6 h after a total hip arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for primary unilateral hip arthroplasty
* Age \>= 18 years
* Able to give informed consent

Exclusion Criteria:

* General anaesthesia for the current procedure
* Digoxin treatment.
* history of renal or hepatic failure
* history of glaucoma
* history chronic urinary retention requiring treatment
* history of orthostatic intolerance / hypotension
* other autonomous nervous system disease
* alcohol or drug abuse
* current malignant disease
* females in the fertile age (possible pregnancy or breast feeding)
* Treatment with anticoagulants
* BMI \> 40 kg/m2
* Dementia or cognitive dysfunction (investigators evaluation)
Physical Activity and Ventricular Arrhythmias

The purpose of the study is to determine the effect of aerobic interval training in patients with an implantable cardioverter defibrillator (ICD) on physical fitness, quality of life and the amount of serious ventricular arrhythmic events on short and long term.

In this study, participants will be randomly assigned to either take part in the exercise program or serve as control and live as usual. At baseline study visit, study researchers will review medical records to collect various information, including the reason for needing an ICD, the type and settings of the ICD, medication use and medical history etc. All participants will undergo blood collection, complete a questionnaire to assess quality of life and undergo examination with echocardiography and ECG. The ICD will be programmed accordingly to international guidelines regarding ICD-therapy and optimal monitoring, before each participant complete an exercise treadmill test to determine VO2 peak. They will wear a Holter monitor to record heart activity 48 hours before the test and 24 hours after the test. All participants will then be observed for 2 months before being randomly assigned to either intervention or control. During this observation period, they will wear a fitness activity tracker wristband to evaluate degree of physical activity and a Holter monitor to register number of premature ventricular contractions. Participants taking part in the interval training group will perform aerobic interval training 4 x 4 minutes intervals, 3 times a week for 12 weeks (week 1-12), whereas participants taking part in the control group will carry on with usual daily life with no lifestyle recommendations. All participants will then undergo a new period of observation (week 13-20) and repeat the tests and examinations performed at baseline and during the observation period prior to intervention/control.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ICD and dilated cardiomyopathy or coronary heart disease as cause for implantation
* ICD implanted at St Olavs hospital, Trondheim

In case of difficulties with patient inclusion for the study, the criteria might be broadened to include patients with idiopathic ventricular arrhythmia as cause for implantation.

Exclusion Criteria:

* inability to accomplish the exercise program due to serious comorbidity or to participate in regular training within the next 3 months due to other reasons
* signs of severe cardiac ischemia or persistent ventricular tachycardia during individualized treadmill O2 peak test, which after individual assessment is to be found at risk
* comorbidity where endurance training at more than moderate intensity is discouraged
* severe cardiac valve disease
* planned surgery within the next 3 months
* inability to give informed consent
The Effect of Insulin Degludec in Combination With Liraglutide and Metformin in Subjects With Type 2 Diabetes Qualifying for Treatment Intensification

This trial is conducted in Africa, Asia, Europe and North America. The purpose of the trial is to investigate the effect of insulin degludec (IDeg) in combination with liraglutide (Lira) and metformin (at least 1500 mg daily or maximum tolerated dose) in subjects with type 2 diabetes qualifying for treatment intensification.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Insulin naïve
* Ongoing treatment with metformin or metformin in combination with either sulphonylurea (SU), glinides, dipeptidyl peptidase-IV (DPP-IV) inhibitors or exenatide (only twice daily (BID))
* Glycosylated haemoglobin (HbA1c) (by central laboratory analysis): a. 7.5-10.0 % (both inclusive) for subjects on metformin monotherapy, b. 7.0-9.0 % (both inclusive) for subjects on metformin in combination with either SU, glinides, DPP-IV inhibitors or exenatide (only BID)

Exclusion Criteria:

* Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria within 12 weeks
* Calcitonin equal to or above 50 pg/mL
* Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty; all within 24 weeks
* Current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell carcinoma)
Analysis of Long Term Risk of Coronavirus Disease-19 Emergency

The aim of this study is to investigate dietary, lifestyle and psychosocial changes possibly occurred during Italy's lockdown, that is in the period of time between March 9 2020 and May 3 2020 (hereafter referred to as the Phase 1 lockdown) in two different populations: the Moli-sani Study cohort and the Italian general population.

The containment measures released by the Italian Government for the period between March 9- May 3 2020 have been aimed to reduce the movement of people from their homes, which was only allowed in cases of special need, and the use of smart work (working from home) wherever possible .As a consequence, the lockdown period is likely to have lasting effects on people and their lifestyles, especially nutrition, and psychosocial well-being.

A web-based questionnaire was developed to retrospectively investigate dietary, lifestyle and psychosocial changes possibly occurred during Italy's lockdown, that is in the period of time between March 9 2020 and May 3 2020 (hereafter referred to as the Phase 1 lockdown).

The potential impact of Phase 1 lockdown on lifestyles will be tested in two distinct population cohorts, that is the Moli-sani Study cohort (established among residents in the Molise region in the period 2005-2010) and a sample of the general Italian population, aged ≥ 18 years.

Eligibility Criteria:
Inclusion Criteria for the Moli-sani Study sub-cohort:

* Re-examination in 2017-2020;
* Able to give verbal consent

Exclusion criteria for the Moli-sani Study sub-cohort:

- Not able to give verbal consent

Inclusion Criteria for the General Italian population cohort:

* Age \>= 18 years.
* All subjects from the general population with access to electronic devices and the Internet (e.g. personal computer, smartphone) and is fluent in Italian will be eligible.

Exclusion Criteria for the General Italian population cohort:

* Subjects younger than 18 years
* Only people with access to personal computers, smartphones and the Internet, and fluency in Italian will be able to participate. These exclusions are not based on age, gender, pregnancy, racial, or ethnic origin.
Testicular Injection of Autologous Stem Cells for Treatment of Patients With Azoospermia

Azoospermia is defined as the complete lack of sperm in the ejaculate. In humans, Azoospermia affects about 1% of the male population and may be seen in up to 20% of male infertility situations. In testicular Azoospermia the testes are abnormal, atrophic, or absent, and sperm production severely disturbed to absent. FSH levels tend to be elevated (hypergonadotropic) as the feedback loop is interrupted. The condition is seen in 49-93% of men with Azoospermia. The purpose of this study is to assess the ability of bone marrow derived stem cells to differentiate into germ cells and their role in treatment of testicular Azoospermia

This study is an open-label investigation of the efficacy of injection autologous adult bone marrow derived stem cells into the somniferous tubules or interstitial spaces of male testis with Azospermia. Sixty men with Azoospermia will be recruited in this study after a written informed consent.

The diagnosis of Azoospermia will be established on the basis of two semen analysis evaluations done at separate occasions; this will be followed by detailed history taking, physical examination and investigations. History taking will include general health, sexual health, past fertility, libido, sexual activity and previous exposure to surgery, drugs, mumps infection and irradiation. Physical examination includes genital and local examination for detection of signs of Klinefelter syndrome, testicular atrophy, absence of vas. Investigations include serum FSH, LH, karyotyping and testosterone levels, and may include testicular biopsy or transrectal ultrasound if indicated (Low levels of LH and FSH with low or normal testosterone levels are indicative of pretesticular problems, while high levels of gonadotropins indicate testicular problems. However, often this distinction is not clear and the differentiation between obstructive versus non-obstructive Azoospermia may require a testicular biopsy).

Subjects will be enrolled based on specific inclusion/exclusion criteria and evaluated at regular post transplant intervals. Human adult bone marrow derived stem cells will be transplanted by an andrological surgeon through a standard surgical approach. Subjects will be monitored frequently for a total of one year after adult bone marrow stem cells cell injection. For safety of participants, Bone Marrow Stem cells will be injected in one testis only and the other testis will be spared.

Eligibility Criteria:
Inclusion Criteria:

* Patients with non-obstructive Azoospermia
* Patients between 25 - 60 years old.

Exclusion Criteria:

* Patients with obstructive Azoospermia
* Men with previous surgery in testis
* Men with infectious genital diseases and anatomical abnormalities of the genital tract
* Those with major medical problems such as malignancy, hepatitis, etc.
* Chromosomal aberration (e.g. Y microdeleion, trisomy....)
Treatment of Depression in Patients With PTSD

Post-traumatic stress disorder is a mental health problem of enormous proportion within the VA system for both male and female veterans. The 40 percent of veterans with PTSD and concurrent clinically significant depression are particularly difficult to treat. Effective and efficient treatment of veterans with this combination of disorders would be of benefit to a significant number of veterans.

Background:

Post-traumatic stress disorder is a mental health problem of enormous proportion within the VA system for both male and female veterans. The 40 percent of veterans with PTSD and concurrent clinically significant depression are particularly difficult to treat. Effective and efficient treatment of veterans with this combination of disorders would be of benefit to a significant number of veterans.

Objectives:

Well-validated treatments of PTSD and its complications are rare. There are no studies of treatment addressing the sequelae of chronic PTSD, including depressive symptomatology. Our study is the first randomized, controlled study of group psychosocial interventions for the combination of PTSD and depression in male and female veterans. The purpose of the study is to evaluate the impact of two psychosocial interventions on clinical outcomes and on the use of hospital resources by veterans with these co-existing disorders.

Methods:

Male and female veterans with both PTSD and depressive diagnoses will be recruited for the study. Male veterans must have combat-related PTSD, and female veterans will have trauma related to sexual assault. Veterans will be randomly assigned to either Self-Management Therapy (Rehm, 1984), a cognitive-behavioral treatment program for depression, or to a Psychoeducational Group Therapy (Dunn, et al., 1998). Both programs involve short-term group therapies that teach veterans about their disorders, and provide them with new strategies and skills for overcoming them. These therapy groups will be in addition to other standard care that veterans receive within the Trauma Recovery Program at the Houston VA Medical Center. Approximately 120 male veterans and 60 female veterans will be enrolled in the program. Participants will be assessed at pretest, posttest, and at 3-, 6-, and 12-month follow-up periods, utilizing various clinician-administered and self-report instruments of psychiatric symptomatology, psychosocial functioning, constructs targeted by the therapy groups, treatment compliances, and satisfaction.

Status:

Final report preparation.

Eligibility Criteria:
Inclusion Criteria:

To be accepted in the study, patients must (a) meet criteria for combat-related (men's cohort) PTSD and either major depressive disorder of dysthymic disorder, (b) not meet criteria for current or past psychosis, score 24 or greater on a Mini-Mental State Examination cognitive screen, (d) not exhibit active suicidality or severity that would preclude participation in the groups, and (e) agree to random assignment and sign informed consent forms. For the women's groups, patients have PTSD related to sexual trauma.

Exclusion Criteria:
Bilateral Gluteal Fascio-myo-cutaneous Flap in Treatment of Recurrent Pilonidal Disease

Bilateral Gluteal Fascio-myo-cutaneous Advancement Flap is a modified technique used in Treatment of Recurrent Sacrococcygeal Pilonidal sinus

Patients with recurrent pilonidal sinus disease are recruited to undergo Bilateral Gluteal Fascio-myo-cutaneous Advancement Flap technique under spinal anesthesia in order to prevent recurrence.

Eligibility Criteria:
Inclusion Criteria:

* Patients with recurrent sacrococcygeal pilonidal disease aging more than 16 years with single or multiple pits were included in the study.
* Patients included presented with recurrence of pilonidal disease at least six months after the first operation.

Exclusion Criteria:

* Patients aging less than 16 years.
* Patients unfit for anesthesia.
* Patients with primary pilonidal disease.
* Patients with acute pilonidal abscess or active infection.