cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Modafinil vs Placebo for Treatment of Anesthesia Delayed Emergence in Obstructive Sleep Apnea

The purpose of this study is to determine whether modafinil use in patients with obstructive sleep apnea will improve postoperative delayed emergence after general anesthesia.

This is a randomized, double blind placebo controlled evaluation of modafinil versus placebo for the treatment of general anesthesia related delayed emergence in patients with the diagnosis of obstructive sleep apnea. 124 patients will be recruited and randomized on the day of surgery to receive 200mg modafinil or placebo. After randomization, patients will proceed to the operative suite for surgical procedure under general anesthesia. The primary outcome measured will be post-anesthesia care unit length of stay. Secondary outcomes will include performance on a post-anesthesia recovery scale.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years or older
2. Meets diagnostic criteria for obstructive sleep apnea
3. Willing and able to comply with study procedures
4. Willing and able to provide informed consent
5. If female, not pregnant or lactating and willing to use an acceptable method of barrier birth control (e.g. condoms) for one month after surgery and discontinuation of study medication (modafinil may reduce the effectiveness of steroidal contraception for one month after discontinuation)

Exclusion Criteria:

1. Have a medical condition that, in the study physician's judgment, may interfere with safe participation (active cardiac conditions such as angina, recent myocardial infarction w/in 6 months, severe renal or liver disease, unstable diabetes, or elevated liver enzymes greater than twice normal).
2. Have a current neurological disorder (e.g. organic brain disease, dementia) or major psychiatric condition that would impair the collection of data (schizophrenia, bipolar illness).
3. Currently on prescription medication that is known to interact with the study drug. (ethinylestradiol and triazolam).
4. Have current dependence on cocaine, methamphetamine, alcohol or benzodiazepines (DSM-IV criteria).
5. Have a history of severe valvular heart disease, severe left ventricular hypertrophy, cardiac arrhythmias, angina, cardiac syncope, or pre-syncope or myocardial infarction \<6 months.
6. Have a history of uncontrolled or poorly controlled essential hypertension, or a heart rate greater than 70% of the maximum heart rate expected for their age (Formula: 0.70(220 - age).
7. Any condition, in the opinion of the principal investigators that would compromise patient safety.
8. A documented history of sensitivity to modafinil.
9. Current Modafinil use for daytime somnolence associated with obstructive sleep apnea.
A Study to Assess the Effect of Danicamtiv on the Drug Levels of Midazolam in Participants With Stable Heart Failure

The purpose of this study is assess the effect of danicamtiv, as an inducer on the drug levels of midazolam in participants with heart failure with reduced ejection fraction (HFrEF).


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory participants with stable HFrEF due to any etiology.
* Body mass index (BMI) of 18.0 kilogram per square meter (kg/m2) to 35.0 kg/m2 inclusive.
* Documented left ventricular ejection fraction (LVEF) 15% to 45% (on 2 occasions), including at least once during Screening and confirmed by the Echo Core Laboratory (the absolute difference between the 2 LVEF values qualifying the participant should be \< 12%).
* Participant receiving chronic medication for the treatment of heart failure reflecting current guidelines, including at least one of the following, unless not tolerated or contraindicated:β-blocker, angiotensin converting enzyme inhibitor, angiotensin receptor blocker, or angiotensin receptor neprilysin inhibitor. Such treatments should have been given at stable doses for at least ≥ 2 weeks prior to screening with no plan to modify treatments during the study.
* Sinus rhythm or stable atrial or ventricular pacing or persistent atrial fibrillation that is adequately rate-controlled to allow pharmacodynamic (PD) assessments by Transthoracic echocardiogram (TTE). NOTE: Participants with implanted cardioverter defibrillator (ICD), pacing, or cardiac resynchronization therapy are eligible provided device programming is unchanged starting 2 months prior to and throughout the dosing period.
* Adequate acoustic windows, determined by the Echo Core Laboratory, to enable accurate TTE assessments.

Exclusion Criteria:

* Presence of disqualifying cardiac rhythms that would preclude echocardiographic assessments, as determined by the Investigator, including: (a) rapid, inadequately rate controlled atrial fibrillation or (b) frequent premature ventricular contractions that might interfere with reliable echocardiographic measurements of left ventricular function.
* History of bronchospasm, or history of respiratory depression or arrest, airway obstruction, oxygen desaturation, or apnea.
* History of allergy to midazolam, other benzodiazepines, danicamtiv, related compounds, or excipients in the formulations.
* Severe renal insufficiency (defined as current estimated glomerular filtration rate \[eGFR\] \< 30 mL/min/1.73 m2 by simplified Modification of Diet in Renal Disease equation \[sMDRD\].
A Study of Effects of Canagliflozin as Add-on Therapy to Insulin in the Treatment of Participants With Type 1 Diabetes Mellitus (T1DM)

The purpose of this study is to assess the effects of administration of canagliflozin 100 mg and 300 mg, compared with placebo as an addition to insulin therapy for the treatment of Type 1 Diabetes Mellitus (T1DM).

This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), placebo-controlled (an inactive substance that is compared with a medication to test whether the medication has a real effect) parallel-group, multicenter study of canagliflozin as an addition to insulin therapy for participants with type 1 diabetes mellitus and inadequate glycemic control.

Approximately 330 participants will be randomly assigned in a 1:1:1 ratio to either canagliflozin 100 mg, canagliflozin 300 mg, or placebo groups. About 90 participants (30 per treatment group) will be selected for a substudy with a purpose of a continuous glucose monitoring (CGM) assessment for 7 days at baseline and 7 days at the end of treatment.

The total duration of the participation will be about 22 weeks, during which participants will need to return to investigational sites for approximately 9 visits. During the study participants will receive advice on treatment of hypoglycemia and diabetic ketoacidosis (DKA), as well as on compliance with diet and exercise.

Eligibility Criteria:
Inclusion Criteria:

* Must have type 1 diabetes mellitus (T1DM) for at least 1 year
* Must have have inadequate glycemic control (as defined by glycosylated hemoglobin level of \>= 7.0% to \<= 9.0%) on basal plus bolus insulin at screening
* Must have body mass index 21 to 35 kg/m2 inclusive
* Must be on a total daily dose of insulin \>= 0.6 IU/kg at screening
* Must be on a stable insulin regimen for at least 8 weeks prior to screening

Exclusion Criteria:

* History of T2DM, pancreas or β-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
* Severe hypoglycemia (defined as an event required assistance from another person, or which resulted in seizure or loss of consciousness) within 6 months prior to study start
* Diabetic ketoacidosis within 6 months prior to study start
* History of hereditary glucose-galactose malabsorption or primary renal glycosuria
* An ongoing, inadequately controlled thyroid disorder
Studying Gene Expression in Tissue Samples From Young Patients With Acute Myeloid Leukemia

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at gene expression in tissue samples from young patients with acute myeloid leukemia.

OBJECTIVES:

* Examine mRNA from pediatric patients with acute myeloid leukemia with 11q23 translocations by reverse transcriptase-PCR to quantify expression of EVI1 splice variants.

OUTLINE: Cryopreserved mRNA from diagnostic samples is analyzed for gene expression by reverse transcriptase-PCR.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of pediatric acute myeloid leukemia with 11q23 abnormalities

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Serum YKL-40 Level and Platelets Indices Among Patients With Diabetic Erectile Dysfunction

The aim of this current study is to estimate serum level of YKL-40, serum total testosterone and platelets indices in diabetic patients with erectile dysfunction treated by daily tadalafil 5mg for 3 months.


Eligibility Criteria:
Inclusion Criteria:

* Diabetic patients with ED.

Exclusion Criteria:

* Patients with history of pelvic trauma.
* Patients with major pelvic surgical intervention.
* Patients with hypogonadism and hyperprolactinemia.
* Patients with chronic liver disease.
* Patients with cardio vascular system diseases.
* History of chronic intake of central nervous system, anti androgen drugs or other drugs as Tramadol.
* Smokers patients.
* Patients with non-vasculogenic Erectile dysfunction.
Understanding COVID-19 Infection in Pregnant Women and Their Babies

This national study will recruit expectant mothers with and without positive nasopharyngeal swabs for SARS-CoV-2, and aims to determine the seroepidemiology of SARS-CoV-2 amongst expectant mothers and their infants in the U.K.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form
* Any woman pregnant in selected hospitals in England who has no signs or symptoms of COVID-19 disease during pregnancy and is rtPCR negative at delivery
* Any woman pregnant in any hospital in England who tests positive by rtPCR at any point during pregnancy from 24 weeks gestation onwards, regardless of signs and symptoms

Exclusion Criteria:

* If the pregnant woman is under 18 years in prison or unable to make an informed consent for other reasons (e.g. learning difficulties, language barriers)
Hoarding Disorder Treatment With Virtual Reality

This study explores whether a facilitated peer support group called Buried in Treasures (BIT) and a virtual reality decluttering practice can help individuals with clutter challenges.

Individuals with clutter challenges participate in Buried in Treasures Workshop (BIT) that has been shown to improve symptoms of hoarding disorder. The investigators hypothesize that adding virtual reality decluttering practice to the BIT workshop will decrease hoarding symptoms and level of clutter over time.

Eligibility Criteria:
Inclusion Criteria:

1. Age greater than 55
2. Either gender and all ethno-racial groups
3. Physically healthy male or non-pregnant female.
4. Hoarding Disorder primary condition
5. Willing and able to understand and complete consent and study procedures
6. English speaking
7. Participant should have the technology to host Zoom calls

Exclusion Criteria:

1. Current or past history of bipolar, psychotic or eating disorders, substance dependence, or substance abuse in the last year.
2. Clinically at risk of suicide with Columbia Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation Subscale of 4 or higher (i.e. suicidal intent without specific plan)
3. Major medical or neurological conditions that increase the risk of participation or that would prevent completing assigned behavioral practice tasks.
4. Unable or unwilling to allow study staff into home for home assessment
5. Currently at high risk for eviction
6. Animal hoarding or squalor
Circle Method Observational Project - Non-interventional, Retrospective, Multicenter Data Collection

The goal of this non-interventional, retrospective data analysis is to validate the circle method for patients with bicuspid aortic heart valves undergoing transcatheter aortic heart valve implantation (TAVI).

The main aims are:

* to assess whether patients with bicuspid aortic valves that received a TAVI suffered from fewer complications

  * if valve size was identical to the one determined using the circle method compared to
  * a case where circle method derived valve size is different from the actually implanted valve
* to develop recommendations on how to size the valve using the circle method.

The bicuspid aortic valve (BAV) is the most common heart valve abnormality and is associated with a number of cardiac complications, including infective endocarditis, aortic dissection, aortic dilatation, and the development of severe aortic stenosis (AS). Due to its anatomical characteristics BAV has been considered a contraindication to transcatheter aortic valve implantation (TAVI), a standard treatment of AS. However, several recent trials have presented promising results indicating TAVI to be a safe alternative to surgery for low risk patients and more patients with BAV have been considered for TAVI.

There are several sizing techniques for TAVI in BAV, including an annular sizing, a supra-annular sizing, and a balloon sizing, yet there is still no consensus on the most appropriate technique. Although annular sizing remains the major approach in most patients with BAV, some BAV anatomies may profit from the supra-annular sizing. Recently published consensus for sizing and positioning the balloon-expandable Edwards SAPIEN 3 transcatheter heart valve (THV) in BAV describes the anatomical features that influence sizing optimization. The novel circle technique has also been proposed in the presence of the unique anatomical factors and sizing at the supra-annular level. This method is particularly helpful for visually identifying anatomic features, indicating the sealing zone at the commissures, visually reassuring of the size and position, and treating patients with large annuli. Currently, there are limited data validating the circle method for identifying sizing and positioning for TAVI in BAV patients.

In this non-interventional, retrospective, multicenter data collection and analysis we aim to validate the circle method for sizing and positioning in bicuspid aortic valves.

Due to the non-interventional character of the project, no additional burden will be put on the patients eligible for inclusion.

Eligibility Criteria:
Inclusion Criteria:

* Patients with bicuspid aortic valves who underwent aortic valve replacement with a balloon expandable valve (SAPIEN 3 / Ultra)
* Computed Tomography data available

Exclusion Criteria:

- none
Effects of Transcranial Direct Current Stimulation on Glucose Level

Previous studies have investigated the impact of tDCS on systemic glucose, neglecting to explore its effects on diabetic factors and its safety. Some studies used small sample size, limiting the ability to identify significant impacts or generalized findings to large population.

The proposed study suggests addressing these gaps by employing a large sample size, comprehensive outcome measurements, assessing tDCS impact on diabetes mellitus (DM) risk variables, and integrating ethical considerations into the research design and implementation. The study aims to fill existing gaps in knowledge about tDCS effects on blood glucose regulation and diabetic risk factors by conducting more robust research methodologies The effects of tDCS on addictive behavior and cerebral glucose metabolism in problematic online gamers were examined in a single-blinded RCT. Over a 4-weekperiod, participants received 12 sessions of either active or sham tDCS to the dorsolateral prefrontal cortex. In the active group, glucose metabolism was enhanced in certain brain regions, showing decreased addiction severity in both groups. As a result of these findings, it appears that prefrontal tDCS is capable of controlling gaming behaviors and enhancing cerebral glucose metabolism

Eligibility Criteria:
Inclusion Criteria:

* Both Male \& Female
* Age 18-30 years

Exclusion Criteria:

* Pregnancy
* Lactating mothers
* Skin Irritation and Allergies
* Brain Tumor or Shunt
* Brain Metallic implants
* Epileptic disease
* GI Disorder and Endocrine Disorder
* Drug abuse
* History of medications any hormonal therapy
Study Comparing EBUS & EUS to Mediastinoscopy in Staging and Detection of Lung Cancer

This is a prospective randomized clinical trial with the study cohort comprised of all male and female patients over the age of 21 presenting to the study site for evaluation of lung cancer. The study will enroll 300 subjects, with 150 in each arm. Three sites will be in the study, Mayo Rochester, Mayo Jacksonville and Medical University of South Carolina. Mayo Rochester will enroll approximately 125 subjects. This study does not require subjects to undergo any additional procedures than what they would receive per standard medical care. The consenting subjects will receive EUS and /or EBUS- guided FNA or Mediastinoscopy/Thoracoscopy.

This is a prospective randomized clinical trial of males and females age 21 or older being evaluated for lung cancer. The study will enroll approximately 300 subjects (150 in each arm) at 3 participating centers (MUSC, Mayo Clinic Rochester and Jacksonville). This sample size will provide sufficient statistical power (i.e. \>80%) using a non-inferiority study design with 1-sided hypothesis testing (Farrington and Manning 1990) to determine whether or not the sensitivity of the EUS/EBUS diagnostic technique is inferior (i.e. 10% or more lower) when compared to the sensitivity of malignant mediastinal adenopathy of about 40%. This study requires subjects to agree to the selection of their standard of care procedure. Subjects will be randomized (stratified computer generated randomization stratified y center and y CT positivity for pathologically enlarged \[\>1cm short axis\] node - 10 strata). Randomization will use variable block sizes (4-8), so that randomization allocation remains concealed as investigators will not be blinded. This study requires subjects to consent to the release of outcome data and follow-up data to be used for study analysis. No additional visit will be required for this study; this study will not require any additional time requirements beyond their scheduled evaluations.

Eligibility Criteria:
Inclusion Criteria:

* Age 21 years or greater
* Pt is a surgical candidate for mediastinoscopy, thoracoscopy, or lung resection
* Known or suspected non-small cell carcinoma of the lung eligible for resection
* CT scan performed within 45 days prior to evaluation for study participation
* PET scan performed within 45 days prior to evaluation for study participation

Exclusion Criteria:

* Pathologically proven metastatic disease
* History of malignancy within 5 years other than (skin) basal cell carcinoma
* Enlarged ipsilateral mediastinal lymph nodes \> 2.5 cm in diameter
* Peripheral T1 tumors with normal mediastinal lymph nodes on CT and PET
Use of Human Dehydrated Amnion/Chorion (DHACM) Allograft in Partial Nephrectomy

After partial nephrectomy, kidney function decreases by about 10% overall and by about 20% in the operated kidney. This is primarily due to the loss of healthy parenchymal volume during resection of the tumor. In an effort to preserve and regenerate healthy parenchyma during the procedure and ultimately renal function after partial nephrectomy, the single center double arm single-blinded randomized screening clinical trial will evaluate the ability of human amnion/chorion allograft to facilitate the recovery of renal function following robotic partial nephrectomy.

To determine whether Amniofix facilitates improved recovery of renal function at 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Any individual with a diagnosis of a renal mass.
* All Patients undergoing partial nephrectomy as their definitive treatment for their renal mass.
* Ability to understand and the willingness to sign a written informed consent.
* Patients with a solitary clinical T1a renal mass.

Exclusion Criteria:

* Patients undergoing radical nephrectomy as their definitive treatment for their renal mass.
* Patients with Transitional Cell Carcinoma.
* Patients with known hereditary syndromes such Von Hippel-Lindau (VHL) syndrome, Lynch Syndrome, Birt-Hogg-Dube Syndrome.
* Patients with metastatic disease undergoing cytoreductive nephrectomy as their definitive treatment for metastatic disease.
* Patients with prior kidney surgery.
* Patients with a solitary or horseshoe kidney.
* Patients with a positive margin found during intra-operative frozen section done only when clinically indicated (i.e., macroscopic abnormality identified).
* Patients with multiple renal masses.
* Patients with greater than a clinical T1a renal mass.
An Immunonutritional Approach to the Prevention of Skin Cancer

Skin cancer incidence continues to rise and ultraviolet radiation (UVR) in sunlight is the principal cause. Solar UVR can promote cancer development through its ability to suppress the immune system. The purpose of this study is to determine whether dietary supplementation with omega-3 polyunsaturated fatty acids can protect human skin from UVR-induced immunosuppression.

Skin cancer is one of the most common human cancers with a rising incidence and considerable negative impact on human health. Exposure to ultraviolet radiation (UVR) in sunlight is the major aetiological factor in skin cancer initiation and progression. Human case-control studies have reported an inverse relationship between dietary fish or omega-3 polyunsaturated fatty acid (PUFA) intake and occurrence of non-melanoma skin cancer. Omega-3 PUFA have the potential to reduce the risk of photocarcinogenesis primarily by their ability to reduce production of prostaglandin E2 and consequently photoimmunosuppression. To date, no studies have assessed the impact of omega-3 PUFA on skin photoimmunosuppression in humans.

OBJECTIVE: To examine the potential of dietary omega-3 PUFA to protect against UVR-induced cutaneous immunosuppression in humans.

STUDY DESIGN: A double-blind randomised controlled nutritional study in 64 healthy human volunteers with nickel sensitivity. Volunteers will receive 3 months dietary supplementation with either omega-3 PUFA (n=32) or gelatine (n=32) both provided in identical gelatine capsules.

The aim is to quantify the influence of omega-3 PUFA on:

1. UVR-induced suppression of clinical contact hypersensitivity (CHS) responses
2. UVR-induced modulation of epidermal Langerhans cell trafficking
3. UVR-induced modulation of levels of immunoregulatory mediators

Eligibility Criteria:
Inclusion Criteria:

* Pre-menopausal females
* Sun-reactive skin type I / II
* Reporting allergy to jewellery with nickel content

Exclusion Criteria:

* History of atopy
* History of skin cancer
* History of a photosensitivity disorder
* Sunbathing (including sunbeds) in the last 3 months
* Pregnancy
* History of cardiac disease
* Taking photoactive medicine
* Not able to eat fish or gelatine
* Taking fish oil supplements prior to the study