cyrilzakka/clinical-trials huggingface dataset:
Study of the Efficacy of Maintenance Therapy Using Uracil-tegafur (UFT) or Bacille Calmette-Guerin (BCG) for the Prevention of Recurrences of Superficial Bladder Cancer (EMBARK Study)

The purpose of this prospective randomized controlled study is to prove the non-inferiority of UFT maintenance therapy to BCG maintenance therapy for preventing recurrences of superficial bladder cancer.

Patients who have undergone transurethral resection of a superficial bladder tumor (TUR-Bt) and BCG induction therapy are eligible for enrollment in this study. In principle, BCG induction therapy consists of the successive weekly intravesical administration of 81 mg of BCG-Connaught strain or 80 mg of BCG-Japan strain for 6 weeks after the completion of TUR-Bt.

The patients will be randomly assigned to a BCG maintenance therapy arm or a UFT maintenance therapy arm. The patients in the BCG maintenance therapy arm will be treated with 3 successive weekly intravesical administrations of BCG at 3, 6, 12 and 18 months after the start of BCG induction therapy. The dosage of BCG used for BCG maintenance therapy will be the same as that used for BCG induction therapy. Patients in the UFT maintenance therapy arm will be treated with the oral administration of 400 mg of UFT everyday for three years after the end of BCG induction therapy.

The primary endpoint of this study is the three-year relapse-free survival rate.

Eligibility Criteria:
Inclusion Criteria:

* Superficial bladder cancer
* Completion of transurethral resection of bladder tumor (TUR-Bt)
* Completion of BCG induction therapy after TUR-Bt. In principle, BCG induction therapy consists of the successive weekly intravesical administration of 81 mg of BCG-Connaught strain or 80 mg of BCG-Japan strain for 6 weeks after the completion of TUR-Bt.
* Age 20 to 80 years
* ECOG performance status of 0 or 1
* Bladder capacity ≥ 150 mL
* Capable of oral UFT administration
* Expected life prognosis ≥ 3 years
* Hematopoietic WBC ≥ 3,000/mm\^3
* Neutrophil ≥ 1,500/mm\^3
* Platelet ≥ 100,000/mm\^3
* Hepatic AST and ALT ≤ 2 times upper limit of normal (ULN)
* Total bilirubin ≤ 1.5 mg/dL
* Hemoglobin ≤ 9.0 g/dL
* Creatinine ≤ 1.5 mg/dL

Exclusion Criteria:

* Bladder cancer located in prostatic part of the urethra
* Anamnesis of bladder cancer classified as cT2, cT3 or cT4
* Anamnesis of metastatic bladder cancer
* Anamnesis of upper urinary tract carcinoma in situ
* Anamnestic treatment of intravesical BCG administration within previous 6 months
* Prior anticancer chemotherapy or radiotherapy
* Severe complication
* Presence of contraindications for the administration of BCG or UFT
* Pregnancy, lactation
Short-term Outcomes of Transanal Total Mesorectal Excision With Structured Training Curriculums in China

Transanal total mesorectal excision (TaTME) is an alternative for mid-low rectal cancer. In China, this procedure has been performed in high-volume centers with structured training curriculums. This study aimed to evaluate the short-term outcomes during the initial implementation of the TaTME procedure in high-volume centers who followed structured training curriculums in China.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 75 years
* American Society of Anesthesiologists (ASA) score I to III
* A biopsy proven histological diagnosis of rectal carcinoma
* Undergoing transanal total mesorectal excision

Exclusion Criteria:

* Pregnant or lactating women
* Synchronous rectal carcinoma
* History of colorectal cancer or other malignant tumors
* Clinical evidence of metastasis
* Emergency procedure
Remote Ischemic Preconditioning in ad Hoc Percutaneous Coronary Interventions

Elective percutaneous coronary intervention (PCI) is associated with troponin release in approximately one third of cases. Myocardial necrosis may result from downstream embolization of atheromatous material, coronary side-branch occlusion and may involve ischemia/reperfusion injury. The investigators hypothesized that a single remote ischemic preconditioning cycle would reduce peri-procedural troponin release.

Elective percutaneous coronary intervention (PCI) is associated with troponin release in approximately one third of cases, which is a sensitive and specific marker of myocyte necrosis. Myocardial necrosis may result from downstream embolization of atheromatous material, coronary side-branch occlusion and may involve ischemia/reperfusion injury. A number of studies have demonstrated that procedure-related troponin release is associated with subsequent cardiovascular events and a worst prognosis, especially in those patients with the most marked elevation in troponin concentration.

Recently, 3 cycles of 5-minute ischemia followed by 5-minute reperfusion of the upper extremities were shown to reduce troponin release in elective PCI. However, this ischemic preconditioning (IPC) protocol requires 30 minutes and is of limited use in the context of PCI at the time of initial cardiac catheterization (ad hoc coronary intervention).

Since experimental evidence suggests that IPC is a graded than an "all-or-nothing" phenomenon, and even a short, single IPC cycle may have protective effects in the myocardium, the investigators hypothesized that patients undergoing ad hoc coronary intervention would have reduced peri-procedural troponin release if subjected to a single, remote IPC cycle, between diagnostic catheterization and coronary intervention.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a significant stenosis as documented in coronary angiography eligible for PCI
* Patients ≥ 18 of age and able to give informed consent

Exclusion Criteria:

* Severe comorbidity (estimated life expectancy \<6 months)
* Use of nicorandil or glibenclamide
* Elevated baseline cTnI before PCI
* Renal disease as documented by serum creatinine before PCI
* LVEF\<35%
Va Meh Du Intervention

This study is a conceptually integrated community-based participatory research study that includes the design and evaluation of an intervention to promote mental wellness and physical activity for Karenni children and young adults.

This study is a non-randomized equivalent design of an implementation and evaluation of an intervention to promote mental health and wellness among Karenni young adults and children by engaging in evidence-based mental health practices, relationship-building and physical activity through the team sport of soccer.

Eligibility Criteria:
Inclusion Criteria:

* Self-identifies as Karenni
* Speaks English or Karenni
* Currently lives in Forsyth County
* Male gender
* Consents to participate

Exclusion Criteria:

* None
Feasibility Test of Virtual Reality Obstacle Detection for Low Vision Walking

The investigators are developing a new test of pedestrian hazard detection in virtual reality (VR) head-mounted display (HMD) headset, which shows virtual oncoming pedestrians in 3D while subjects are walking in real-world environment, for evaluation of visual field expansion to improve mobility in people with visual field loss.

The investigators will develop a new pedestrian hazard detection test and conduct a single arm interventional clinical trial to evaluate simulated low vision assistive devices in a sample of field loss subjects. Pedestrian detection performance with and without field expansion information will be tested and compared. The study will include 1 to 4 visits (each 2 to 4 hours) depending on the number of trials and experimental conditions (e.g., with and without simulated assistive devices) the subject is comfortable completing. The time between visits may vary depending on scheduling constraints and availability. During each visit, the subject will complete a series of simulated collision avoidance trials in VR requiring the detection and natural avoidance of a colliding pedestrian (alongside non-colliding pedestrians) while physically walking through an empty corridor. The study will be considered minimal-risk since there will be no physical obstacles that present actual collision risks.

Eligibility Criteria:
Inclusion criteria:

* At least 14 years of age (no upper age limit)
* In sufficiently good health to be able to complete sessions lasting 2-3 hours
* Able to understand English
* Able to give voluntary, informed consent
* Able to independently move short distances
* Binocular vision parameters within normal limits (Stereopsis ≤ 100 arc sec on any stereo test)
* Visual field loss, either peripheral field loss (\<30 degrees diameter) or hemianopic field loss (blind in half of visual field)
* Better than 20/100 visual acuity in the worse eye

Exclusion criteria:

* Patients with any self-reported physical or mental disabilities, including cognitive dysfunction, balance problems, or other deficits that could impair their ability to respond to the stimuli presented in this study
* Any person with a self-reported medical history (such as pacemaker use or photosensitive epilepsy) or physical condition listed on the device manual of the Oculus / HMD system used for the experiment as a contraindication
* Any self-reported history of seizures (any type) in the last 6 months
A Trial Investigating Lu AF28996 in Adult Japanese Participants With Parkinson's Disease (PD)

This trial will evaluate the effects of Lu AF28996 in adult Japanese men and women with Parkinson's disease (PD). The main goals of the trial are to learn more about a) the safety and tolerability of Lu AF28996 (any new or worsening medical issues the participants have with treatment), and b) the pharmacokinetic parameters of Lu AF28996 (how the drug is absorbed, distributed, and processed by the body). Participants will take Lu AF28996 capsules orally once a day (OD). The participants will start with a low dose of Lu AF28996, which will be increased gradually over a period of 2 weeks, and then decreased gradually over a period of about 2 weeks.


Eligibility Criteria:
Inclusion Criteria:

* The participant is diagnosed with idiopathic PD (consistent with the United Kingdom Parkinson's Disease Society Brain Bank Criteria for the Diagnosis of Parkinson's Disease) and should not have more than 1 first-degree relative with PD.
* The participant's Modified Hoehn and Yahr score is ≤3 in the ON state and ≤4 in the OFF state.
* The participant experiences well-recognizable and predictable motor fluctuations (≥1.5 hours of OFF-periods in the awake time, predictable morning OFF episodes included) causing clinically significant disability during the 7-week Screening Period.
* The participant currently has a good response to levodopa and has been receiving a stable dose of levodopa (≥3 doses per day of levodopa/dopa decarboxylase inhibitor therapy) ≥4 weeks prior to screening.
* The participant is Japanese, defined as having four Japanese grandparents and being born in Japan.

Exclusion Criteria:

* The participant has or had one or more of the following conditions that are considered clinically relevant in the context of the study; other neurological disorder, psychiatric disorder, seizure disorder or encephalopathy, respiratory disease, hepatic impairment or renal insufficiency, metabolic disorder, endocrinological disorder, hematological disorder, infectious disorder, any clinically significant immunological condition, or a history of narrow-angle glaucoma.
* The participant has a positive test result for SARS-CoV-2 at the Baseline Visit.
* The participant has undergone a neurosurgical intervention for PD (such as pallidotomy, thalamotomy, fetal or stem cell transplantation or deep brain stimulation).

Note: Other inclusion and exclusion criteria may apply.
HEdia eXercise Algorithm - HEXA Study.

A randomised controlled crossover pilot study to evaluate safety and efficacy of a digital insulin bolus calculator with a physical activity module

Hedia Diabetes Assistant is a software device intended to monitor blood glucose and to support in the decision making of the optimal bolus insulin dose for management of insulin-dependent diabetes by providing the user with an indicative Bolus insulin dose.

This study has been designed to investigate the safety and efficacy of a digital insulin bolus calculator with a physical activity module that provides guidance on insulin reduction to patients with type 1 diabetes mellitus prior to and after exercise, based on exercise duration and intensity compared with the patients' habitual diabetes management.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent.
* Ability to understand, speak and read Danish fluently.
* Diagnosis of type 1 diabetes mellitus for ≥12 months.
* Age between ≥18 and \<60 years.
* Minimum one measurement of HbA1c between 6.0 to 8.6 % (42 to 70 mmol/mol) within the last four months. If several measurements, then it is the latest one that counts.
* Body mass index (BMI) between ≥18.5 and \<30 kg/m2.
* Ability to use an Apple® (iOS version 13 and up) or Android® (Android version 8.0 and up) smartphone.
* Treated with the same pen-based insulin regimen with basal insulin (insulin glargine, degludec, or detemir) and meal time insulin (insulin aspart, lispro, glulisine) for at least the three preceding months.
* Patients who can perform 45 min. of exercise at moderate intensity on an ergometer bike (investigator assessment).
* If female participants of childbearing potential; willing to have a pregnancy test performed and to use a highly effective method of contraception.

Exclusion Criteria:

* Already using Hedia Diabetes Assistant.
* Use of human insulin or premixed insulin.
* Blood pressure \> 180/105 mmHg.
* Treatment with sodium-glucose transporter 2-inhibitors, glucagon-like peptide 1 receptor agonists, or glucocorticoids.
* Job situation entailing night shifts.
* Fever.
* A mental state impeding compliance with the protocol.
* Expected non-compliance with the protocol at the discretion of the principal investigator.
* Pregnancy.
* Breast-feeding.
* Dialysis therapy or eGFR \< 60 ml/min.
* Patients diagnosed with claudicatio intermittens, heart failure, ischaemic heart disease or stroke.
* Patients prescribed with beta blockers.
* Abuse of alcohol or drugs in the past two years.
* On-going participation, or participation within the last 3 months, in an organised clinical study in which participants received study medication (investigator assessment).
* Surgery scheduled for the study duration period.
* An episode of diabetic ketoacidosis or severe hypoglycaemia requiring third-party assistance within the preceding 6 months.
* Known gastroparesis.
The Impact of Pomegranate Extract on Chronic Cardiomyopathy Complicated by Renal Insufficiency (ImPrOVE): a Pilot Study

This blinded, controlled study will examine the impact of pomegranate polyphenol extract (POMx, from Pom Wonderful, LLC), 1000mg on cardiomyopathy in subjects with chronic renal insufficiency.

Heart failure (HF) is a disease of great prevalence in the U.S. with an associated high morbidity and mortality. In individuals with concomitant chronic renal insufficiency (CRI), outcomes are even worse due to pharmaceutical under treatment and higher baseline levels of oxidative stress. Reactive oxygen species (ROS) are generated during mechanoenergetic uncoupling and can cause myocardial protein, lipid, and DNA damage, leading to the development of HF. One means of preventing the progression of HF may be through ROS reduction or an improvement in systemic or local oxidative stress handling. In this randomized, single blind placebo-controlled pilot study, we hypothesize that 12 weeks of treatment with oral pomegranate extract (POMx) will lead to a reduction in oxidative stress (as assessed by measuring thiobarbituric acid-reactive substances, F8-isoprostanes, and glutathione) in subjects (n=30) with cardiomyopathy (LVEF ≤40%) and CRI (GFR \<60 ml/hr). Secondary aims include assessing the impact of POMx on myocardial remodeling and endothelial dysfunction by measuring serum collagen levels and asymmetric dimethylarginine, respectively. Findings from this study will serve as pilot data for a larger randomized trial of longer term POMx therapy in subjects with cardiomyopathy.

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects (≥21 years of age) with cardiomyopathy (ejection fraction ≤40%) of at least 1 year duration and CRI (GFR \<60 cc/hr for at least 3 months) will be eligible for enrollment.
* Subjects must have New York Heart Association (NYHA) functional class I-III symptoms and be on stable doses of HF evidence-based therapies (β-blocker, ACE inhibitor or ARBs, aldosterone inhibitor \[if appropriate\]) for at least 3 months or have a documented contraindication or intolerance to such therapy

Exclusion Criteria:

* Subjects admitted to a hospital for acute myocardial infarction (defined as positive troponins) or HF exacerbation within the last 6 months will not be eligible for enrollment.
* Subjects on warfarin or rosuvastatin will also be excluded.
* Other exclusion criteria are as follows:

  * HF that is deemed to be congenital or infiltrative in etiology
  * the presence of a life-threatening illness with a projected survival ≤6 months; ongoing infection
  * pregnancy
  * inability to follow-up
  * end-stage renal disease requiring dialysis
  * renal transplant listing
  * recent (within last 6 months) POMx use or intake \>8 ounces daily of pomegranate juice
  * known hypersensitivity to any fruit in the Punicaceae family
  * connective tissue or collagen vascular disease
Physical Activity and Obesity

The purpose of the study is to see if a twelve-week exercise intervention in overweight or obese subjects with pre-diabetes or early disease course type 2 diabetes can lead to improved skeletal muscle capillary blood flow by improving substances that dilate blood vessels and result in improved insulin sensitivity.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females ages 30-60 years of age
2. Overweight and Obese (28\< BMI \<45)
3. Confirmed pre-diabetic (5.7≤ HbA1c \< 6.5)
4. Type 2 DM, Diagnosis 2 years or less, on no medications or metformin only, HbA1c ≤ 6.7

Exclusion Criteria:

1. Stage 3 chronic kidney disease (glomerular filtration rate \[GFR\] \< 60)
2. Obstructive Coronary artery disease
3. Congestive heart failure (ejection fraction \< 55%)
4. Peripheral vascular disease,
5. Degenerative joint disease, musculoskeletal disease, or peripheral vascular disease that limits ability to exercise
6. Know hypersensitivity to Definity® ultrasound contrast agent
7. Intra-cardiac or pulmonary shunt
8. The use of antithrombotic agents or a severe bleeding diathesis due to risk of bleeding with intravenous and arterial line placement
9. Physical activity greater than three hours per week
10. Pregnancy
Neurobiological Correlates of Post Traumatic Stress Disorder (PTSD) During Rapid Eye Movement (REM) Sleep

The overarching aim of this Exploratory/Developmental Research Grant Award (R21) is to explore the neurobiological correlates of PTSD during REM sleep by using state-of-the science positron emission tomography (PET) sleep imaging. This study will allow us to gain insight into the differences in sleep and waking brain mechanisms between veterans with PTSD and those without PTSD.


Eligibility Criteria:
General Inclusion Criteria:

* Male OIF/OEF returnees between the ages of 18 and 45 years old
* Combat Exposure Scale score \> 17
* Not taking medications known to affect sleep or wake function for at least 2 weeks (6 weeks for fluoxetine).
* No history of trauma before age 18

Specific Inclusion Criteria for Subjects with PTSD:

* Meet diagnostic criteria for current PTSD according to the CAPS-1
* CAPS-1 score is less than 80

Specific Inclusion Criteria for Subjects without PTSD:

* Total CAPS-1 scores \< 17
* Does not meet criteria for PTSD

Exclusion Criteria:

* Trauma occurred less than 3 months prior to study entry
* CES score \< 17
* Taking medications known to affect sleep and / or brain glucose metabolism
* Current diagnosis of depression as determined by the SCID or BDI score \> 13
* History of psychotic or bipolar disorder
* Current history (within 3 months) of substance or alcohol abuse as determined by the SCID
* Positive alcohol blood test at screening or during the PET protocol
* Significant or unstable acute or chronic medical conditions
* Other current sleep disorders, such as insufficient sleep syndrome, delayed sleep phase syndrome, narcolepsy, restless legs syndrome, periodic leg movement disorder, obstructive sleep apnea, and current night shift work, suspected during the structured interview. Individuals who are found to have a apnea-hypopnea index (AHI) \> 10 or an index of periodic leg movements with arousal \> 15 will be excluded.
* Presence of implanted devices such as cardiac pacemaker, aneurysm clip, ear implant, shrapnel, neurostimulators or other metal devices
* Fear of closed spaces
* Previous radiation. Due to the risk of radiation exposure, we will exclude subjects who have had PET scans or other radiotracer exposure in the previous year.
* History of open head injury.
Blood Samples From Patients on a Clinical Trial to CINV During HSCT

RATIONALE: Studying samples of blood in the laboratory from patients with cancer may help doctors learn more about nausea and vomiting caused by cancer treatment.

PURPOSE: This laboratory study is looking at blood samples from patients with cancer who were treated on a clinical trial to control nausea and vomiting during donor stem cell transplant.

OBJECTIVES:

Primary

* To compare the amount of substance P in serum samples from patients with cancer treated with busulfan/cyclophosphamide or cyclophosphamide/total body irradiation conditioning regimens prior to undergoing allogeneic hematopoietic stem cell transplantation.

Secondary

* To assess the changes in substance P over time to see if there is an optimal time shown by this physiologic correlate to discontinue substance P blockade after the chemotherapy regimen is completed in these patients.

OUTLINE: Previously collected serum samples are analyzed by enzyme immunoassay for changes in substance P levels.

Patients' medical records are reviewed for demographic information, past history, and course of treatment.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Previously collected serum samples from patients with cancer enrolled on the placebo arm of the pilot aprepitant study

  * Patients treated with busulfan/cyclophosphamide or cyclophosphamide/total body irradiation conditioning regimens prior to undergoing allogeneic hematopoietic stem cell transplantation

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics