cyrilzakka/clinical-trials huggingface dataset:
Determinants of Bladder Cancer Recurrence Study (The DETER Study)

The purpose of this study is to learn how different lifestyle factors, such as cigarette smoking and body weight, change after a diagnosis of bladder cancer, and how they influence who gets a bladder cancer recurrence and who does not.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years old AND
* Histologically-confirmed non-muscle invasive bladder cancer (NMIBC)

Exclusion Criteria:

* Patients are ineligible for the study if they have/had:
* Histologically-confirmed NMIBC diagnosed \>36 months prior to enrollment
* Cystectomy prior to enrollment
* Any condition, which in the opinion of the primary MSK clinician or investigators precludes their ability to provide informed consent or comply with study procedures
* Non English-speaking
Effect of Intra-procedure Music on Anxiety

The purpose of this study is to examine the effects of intra-procedure music intervention on procedural anxiety, physiological stress and sedation requirements in patients undergoing moderate sedation procedures. Study participants will be randomly assigned into two groups: 1. Control - standard care without music intervention. 2. Intervention - standard of care plus music intervention. The State-Trait Anxiety Inventory questionnaire will be provided pre, intra and post procedure to all subjects in addition to an exit survey.


Eligibility Criteria:
Inclusion Criteria:

* Adult (\>18 years old) patients
* Scheduled for moderate sedation procedures in the Interventional Radiology department at Tisch Hospital, NYU Langone Health in New York, New York
* Able to read and write in English at a sixth grade level (STAI is written at sixth grade comprehension level)

Exclusion Criteria:

* Not a moderate sedation candidate (hemodynamically unfit, not optimized for procedure, pregnant)
Predictive of Biomarkers of Healing in Chronic Venous Ulceration of the Lower Limb

Chronic venous ulceration of the lower limb poses a significant problem to patients and healthcare providers alike. 1% of the population of Western countries have either an open or healed chronic venous ulcer.

However, the pathophysiological abnormalities are not entirely clear in how raised venous pressure translates into the changes seen in the skin culminating in an open ulcer. The standard treatment of this condition in the United Kingdom is to undertaken compression bandaging of the lower limb.

In order to further their knowledge of venous ulceration, the investigators seek to determine the biological profile of venous ulcers over a maximum of twenty-eight weeks and by dividing the groups into healing and non-healing wounds, the investigators may be able to demonstrate a difference in the biological profile.

This work may provide insights into predicting who will respond to treatment and targets for treatment in the future.

Forty patients with chronic venous ulceration of the lower limb who meet the inclusion criteria will be entered into the study and assessed over a twenty week period with assessments at week 0, 1, 2, 4, 8, 12 and 20. Urine, serum and ulcer fluid will be sampled.

If the ulcer has not healed, further assessments using an approved biological dressing will be undertaken at weeks 20, 21, 22, 23, 25 and 28 with further sampling of ulcer fluid, urine and serum.

Samples will undergo metabolic profiling using established metabolic profiling techniques developed at Imperial College.

Eligibility Criteria:
Inclusion Criteria:

* Male or female over the age of 18 years
* Chronic venous ulceration - Defined as wound of greater than four weeks in duration between the foot and the ankle with an Ankle Brachial Pressure Index greater than 0.85.
* Ulceration present for at least four weeks.
* Colour venous duplex evidence of chronic venous insufficiency showing either reflux or obstruction.

Exclusion Criteria:

* Acute infection in the studied lower limb within the last four weeks
* History of malignancy in the lower limb to be studied
* History of connective tissue disease
* Patients on medications that can cause immunosuppression - Corticosteroids, chemotherapy or radiotherapy for cancer and recombinant immunological medications.
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) China Single-Arm Study

Abbott Vascular (AV) obtained marketing approval for the XIENCE PRIME Everolimus Eluting Coronary Stent System (XIENCE PRIME EECSS) in China from the China Food and Drug Administration (CFDA) on August 10th, 2011.

This prospective, observational, open-label, multi-center, single-arm, post-approval study is designed to evaluate the continued safety and effectiveness of the XIENCE PRIME EECSS in a cohort of real-world patients receiving the XIENCE PRIME EECSS during commercial use in real-world settings in China.

This study has no primary outcome measure. All observations are of equal weight.


Eligibility Criteria:
Inclusion Criteria:

* The patient must be at least 18 years of age at the time of signing the informed consent.
* The patient or his/her legally-authorized representative signs the European Commission (EC)-approved Informed Consent Form (ICF).
* Only XIENCE PRIME stent(s) is (are) implanted during the index procedure.

Exclusion Criteria:

* No other exclusion criteria are specified for this study.
Topical Application of Silver Nanoparticles and Oral Pathogens in Ill Patients

The purpose of this study is to determine whether oral topic silver nanoparticles are effective to reduce potential pathogen microbial loads in mechanical ventilation patients.

All patients were performed with oral hygiene as recommended by the clinical practice guidelines for the prevention, diagnosis and treatment of pneumonia associated with mechanical ventilation. After that, placed the treatment of an innocuous gel compound with 12ppm of silver nanoparticles or gel alone according to randomization. Then obtain and plant samples taken before the treatment 6 hours after. Comparing the results of the baseline sample with the final.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with at least 24 hrs application endotracheal tube and ventilator support were nasogastric tube ,in the ICU of Hospital Central "Dr. Ignacio Morones Prieto"
2. Patients with at least 24 hours of ICU admission.
3. Sedo - analgesia patients in a coma or induced coma.
4. Over 15 years old
5. Informed consent signed by a family member or legal guardian of the patient.

Exclusion Criteria:

1. The patient is not taking part in another study that cause conflict with the present test.
2. Patients who develop bronchiectasis , severe or massive hemoptysis , cystic fibrosis.
3. Patients with known sensitivity to silver.
4. Patients who had reported difficult intubation in the record.
5. Patients whose physical condition does not allow the completion of the oral examination, proper sampling or application of gel.
6. Pregnant women
7. Patients with oral mucositis
Right Ventricular Diastolic Dysfunction

Heart-lung interactions remain misunderstood whereas pulmonary and cardiac pathologies are very commonly associated.

Emphysema by increasing intrathoracic pressure appears to affect cardiac function.

Interestingly, previous studies have shown a link between the telediastolic volume of the right ventricle (measured by RMI) and the intensity of emphysema.

Our hypothesis is that the emphysema by increasing intrathoracic pressure leads to or accentuates right cardiac diastolic dysfunction by decreasing compliance and cardiac preload.

To verify this hypothesis the investigators will perform KT loop procedures in order to acquire intracardiac pressure/volume curves before and after lung volume reduction.

The pressure/volume curves allow the analysis of systolic and diastolic function, cardiac contractility and loading conditions.


Eligibility Criteria:
Inclusion criteria:

* At least 40 years
* A smoking history
* Smoking cessation ≥ 6 months
* FEV1/FVC ≤ 0,7
* Severe emphysema (destruction ≥ 50%)
* Peak tricuspid regurgitation velocity \< 2,8 m/s or presence of other echocardiographic "PH signs"
* 15% ≤ FEV1post ≤ 50%
* Residual volume ≥ 175% predicted
* TLC ≥ 100% predicted
* Optimal medical management
* 150m ≤ 6MWD ≤ 500m
* mMRC ≥ 2
* Physical activity ≥ 2/Week (≥ 30minutes)

Exclusion criteria:

* ≥2 hospitalizations/year for EACOPD
* Recent EACOPD (≤ 3months)
* ≥ 50ml mucus/day
* PAPm ≥35mmHg
* PaCO2 ≥ 55mmHg
* Bubble ≥ 1/3 hemithorax
* Lung fibrosis, bronchiectasis, lung cancer, homolateral surgery
* Left ventricular ejection fraction ≤ 45%, unstable heart disease
* Life expectancy ≤ 1 year
* Contraindication to anesthesia
* Allergy to nitinol or silicone
* Corticotherapy ≥ 10mg/day
* Patient under legal protection
Fast Muscle Activation and Stepping Training (FAST) Post-stroke

The purpose of this study is to determine whether FAST (Fast muscle Activation and Stepping Training) exercises will improve walking balance in individuals after stroke to a greater extent than usual care.

Hypothesis: The primary hypothesis is that improvements in walking balance will be larger following 12 sessions of FAST exercise retraining compared to usual care in persons in the sub-acute phase after stroke.

It is estimated that 75-80% of individuals who have had a stroke will survive the acute event and be left with residual disability. Regaining independence in standing and walking is of utmost importance for patients recovering from stroke. Walking balance requires muscles in the legs and trunk to contract quickly if people lose their balance. Physical therapy plays a key role in the rehabilitation of walking balance in individuals after stroke. Given that maintaining one's balance requires fast muscle activity, rehabilitation post-stroke should focus on speed of movement. Thus we are proposing to compare a program that emphasizes speed of movement, Fast muscle Activation and Stepping Training versus an active control (usual care).

Eligibility Criteria:
Study population: Subjects with a diagnosis of stroke

Inclusion Criteria:

* first stroke (\<6 months ago)
* presence of hemiparesis in the lower extremity
* minimum Berg Balance Score (BBS) of 30/56
* cognitive ability to give informed consent

Exclusion Criteria:

* bilateral stroke, or a previous stroke in the other hemisphere
* severe co-morbidity that is likely to dominate the pattern of care
* co-existing peripheral neuropathies or disorders of the vestibular apparatus
* musculoskeletal problems
* global aphasia or receptive aphasia
A Novel Imaging Protocol in Use to Identify Lymph Nodes and Organs of Interest

This research study is a pilot clinical trial, which hypothesizes that the combination of electromagnetic tracking in conjunction with laparoscope imaging and ultrasound probe imaging will aid in reducing the complexity of both laparoscopic lymphadenectomy and/or organ removal in patients with a confirmed diagnosis of cancer in urologic regions of interest (Bladder, Prostate, Testicular, Kidney, Urethral, and Penis), by resulting in better visualization and more accurate localization of certain areas in the diseased organ or the diseased lymph node, and allowing for improved surgical and patient outcomes, fewer complications and better clinician performance.

Participants in this research study, may or may not have a tumor within a urologic region of interest such as the bladder, prostate, testicle, kidney, urethra, and penis which may or may not have spread to a lymph node and have been scheduled to undergo a lymph node dissection procedure and/or organ removal surgery within one of the previously mentioned urologic regions of interest concerning for urologic cancer.

This research study involves the use of a standard of care laparoscope and ultrasound probe. The laparoscope and ultrasound probe will have an electromagnetic sensor attached which will assist in the tracking of lymph nodes of interest or organs of interest.

It is expected that the entire time to record the data will be less than 10 minutes.

A total of 10 people will take part in this research study

This study is supported by Siemens Medical USA.

Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent before any trial-related procedure is undertaken that is not part of the standard patient management
* Subjects aged ≥ 18 years. Selected patients must have a confirmed or suspected diagnosis of disease in urologic regions of interest, with scheduled confirmatory surgical biopsy.
* Subjects must have had either of the following scans: CT, PET or MR of acceptable quality at Brigham and Women's Hospital within the past year.
* Subjects must also be scheduled to undergo lymph node dissection for a urologic cancer or organ removal of any of the following urologic regions of interest: Bladder, Prostate, Testicle, Ureter, Kidney, Urethra, Penis, and Scrotum
* Subjects must also be scheduled to undergo a laparoscopic lymph node dissection and/or a urologic organ removal within any OR at BWH.

Exclusion Criteria:

* Severely impaired renal function with an EGFR \< 30 mL/min/body surface area
* Evidence of any significant, uncontrolled comorbid condition that could affect compliance with the protocol or interpretation of the results, which is to be judged at the discretion of the PI
* History of hypersensitivity or other contraindication to contrast media
* Contraindication to general anesthesia
* Pregnancy
Pharmacokinetic Properties and Effect of Food on Pharmacokinetic Properties of the Oral Lafutidine Tablets

This study was to evaluate the pharmacokinetics of single and multiple doses of oral lafutidine tablets and the effect of food on pharmacokinetics in healthy Chinese subjects. The tolerability and the effect of sex on the pharmacokinetic properties were also evaluated to acquire more pharmacokinetic information.

The study of single-dose was randomized, three-period, crossover. And in this study, 12 subjects were randomly assigned to 3 dose groups and received a single dose of 10mg, 20mg and 40mg lafutidine tablets. The washout period was 7 calendar days. In the multiple-dose, 12 subjects took lafutidine tablets of 10 mg twice a day for 6 consecutive days. In the food-effect study, 12 subjects were randomly assigned to 2 groups. One group received a single dose of 10mg lafutidine tablets under fasted condition, while the other were in fed condition. The drug administrations were separated by a wash-out period of seven calendar days. In each study group, the male and the female are both in half of the subjects. Using a liquid chromatography tandem mass spectrometry (LC/MS/MS) method to determine the plasma concentration of lafutidine. Pharmacokinetic parameters were calculated using the single compartment model.

Eligibility Criteria:
Inclusion Criteria:

* body mass index between19 and 24 kg/m2
* negative for HIV and hepatitis B
* had no clinical important findings on health tests
* thorax radiography and ECG with no abnormalities
* normal blood pressure values
* heart rate

Exclusion Criteria:

* any drug treatment within 2 weeks before starting the study
* participation in another clinical study within the previous 3 months
* alcoholism and smoking
* pregnancy
* breast-feeding
* hypocalcemia
* blood donation or participation in other clinical trials within 3 months before enrollment in the study
* sitting blood pressure \<80/50 mm Hg or \>140/100 mm Hg
* A ventricular rate \<60 beats/min or \>100 beats/min at rest
The Benefit of Adding Fish Oil to the Nutrition of Critically Ill Patients

We study whether an increased proportion of omega-3-fatty acids (contained in fish oil) in the nutrition of critically ill patients reduces systemic inflammation.


Eligibility Criteria:
Inclusion Criteria:

* indication for parenteral nutrition

Exclusion Criteria:

* hypertriglyceridemia
* coagulation disorder
* decompensated liver cirrhosis or acute liver failure
The Safety and the Efficiency of Hyperbaric Oxygen in Traumatic Brain Injury

The goal of this observational study is to learn about the safety and long-term effects of hyperbaric oxygen therapy in participants over the age of 18 with traumatic brain injury (TBI).

The main question it aims to answer are:

Does hyperbaric oxygen therapy raise independence in daily living and the ability to engage in social activities in participants with TBI when treated with hyperbaric oxygen therapy during the non-acute phrase after injury? What medical problems do participants have when treated with hyperbaric oxygen therapy? Whether or not participants have used hyperbaric oxygen therapy as part of their routine medical treatment for TBI, they will answer online or telephone survey questions about their functional independence for 2 years.

The goal of this observational study is to learn about the safety and long-term effects of hyperbaric oxygen therapy in participants over the age of 18 with traumatic brain injury (TBI). This is a multicenter prospective cohort study.

The main question it aims to answer are:

Does hyperbaric oxygen therapy raise independence in daily living and the ability to engage in social activities in participants with TBI when treated with hyperbaric oxygen therapy during the non-acute phrase after injury? What medical problems do participants have when treated with hyperbaric oxygen therapy? Whether or not participants have used hyperbaric oxygen therapy as part of their routine medical treatment for TBI during non-acute phrase after injury, they will answer online or telephone survey questions about their functional independence (including cognitive functioning, physical disability, mental status, employment and social activities) for 2 years.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18\~90 years old
2. Patients with traumatic brain injury admitted to the rehabilitation department meet one of the following indicators:

1) Clear history of exogenous trauma-causing disease (such as car accidents, heavy objects, falls, violent assaults, explosive injuries, etc.) 2) GCS score of 3 to 15 points (excluding all kinds of poisoning, sedation, shock factors) 3. Clear presence of at least one of the following imaging signs on cranial CT or MRI: Traumatic intracranial hemorrhage, subdural hematoma, epidural hematoma, cerebral contusion, ventricular hemorrhage, subarachnoid hemorrhage, or brainstem injury; 4. good compliance, signed informed consent, and those who were judged by the investigator to be eligible for enrollment.

Exclusion Criteria:

1. Sequelae of previous spinal cord injury or combination of spinal cord injury in this injury;
2. Severe coagulation disorders;
3. Pregnancy status;
4. Any other factors that the investigator considers to be a potential risk to the subject or that interfere with the subject.
Multimodal Brain Imaging of the Neural Effects of Methylphenidate in Patients With ADHD

The investigators' goal is to develop neuroimaging biomarkers to predict response to treatment with methylphenidate, which then can be used in the development of novel pharmacological treatments for attention-deficit/hyperactivity disorder (ADHD). The overall objective of this study is to measure the changes in task-related neural activity related to symptoms of ADHD (measured by functional MRI) and brain glutamate levels (measured by magnetic resonance spectroscopy, MRS) after treatment with methylphenidate (MPH). This will be a double-blind crossover of methylphenidate and placebo in adults with ADHD. Participants will complete neuropsychological testing along with fMRI and MRS scans after a single dose of each treatment.


Eligibility Criteria:
Inclusion Criteria:

* right handed

Exclusion Criteria:

* pregnant or breast feeding
* past or current neurological disorder
* non-ADHD cause of cognitive impairment
* uncontrolled medical disorder
* head trauma with loss of consciousness in the last year or any evidence of functional impairment due to and persisting after head trauma
* having an adverse reaction to methylphenidate, or other stimulant medication
* having a contraindication to MRI
* current smoking
Mycophenolate Mofetil in Membranous Nephropathy

Patients with idiopathic membranous nephropathy and renal insufficiency are at risk for end-stage renal disease (ESRD). Treatment with cyclophosphamide is currently used as a treatment modality. Mycophenolate mofetil is a new immunosuppressive agent with fewer side effects.

In this pilot study patients with membranous nephropathy and renal failure will be treated with mycophenolate mofetil and prednisone. The outcome will be compared with historical controls treated with a similar regimen containing cyclophosphamide.


Eligibility Criteria:
Inclusion Criteria:

* Membranous nephropathy
* Serum creatinine (Screat)\> 1,5 mg/dl or ECC \< 70 ml/min or increase Screat \> 50%
* Proteinuria \> 2 g/day

Exclusion Criteria:

* Systemic diseases
* Pregnancy wish
* Active infection
* Liver dysfunction
* Abnormal hematology lab
* Unstable angina
* Nonsteroidal anti-inflammatory agents (NSAIDs)
N-acetyl-cysteine and Carbohydrate Metabolism Disorder in Obese Women

The effect of N-acetylcysteine supplementation on carbohydrate metabolism disorder and homocysteine concentrations in obese women will be analysed.


Eligibility Criteria:
Inclusion criteria:

* women diagnosed with carbohydrate metabolism disorder,
* obesity (BMI \>29,9 kg/m2)
* patients not participating in other similar research programs at the same time,
* written agreement to take part in the research.

Exclusion criteria:

* the use of medicament that may affect on carbohydrate metabolism within 4 weeks,
* failure to comply with dietary recommendations established during the nutritional intervention,
* pregnancy and breast feeding.
Interference of Biotin Supplementation in Biotin-streptavidin Platforms for Hormone Testing

The B vitamin biotin is widely available as an over the counter supplement, often advertised and used to promote health of hair, skin and nails. Commercially available over the counter biotin supplements contain dose ranges up to 10 mg/day (ie 333 times higher than the recommended dietary allowance). The biotin molecule is also sometimes used as part of the lab technology to measure hormone and protein levels in the blood. It is possible that high doses of ingested biotin may interfere with accurate hormone or protein measurement using biotin related in vitro measurement systems. Such interference, if present, could lead to misdiagnosis. The study will analyze laboratory levels obtained with streptavidin-biotin assay systems while ingesting biotin in currently available high dose supplements. The data will be compared to measurements obtained prior to and one week after stopping the biotin supplement.

Specimens will be collected by venipuncture at 3 time points, including baseline (time 0), after one week of biotin supplementation (time 1, day 7), and then one week later (time 2, day 14). The time 1 specimen will be drawn approximately 2 hours after the last ingested dose of biotin on day 7. Specimen collection will include three 10 ml red top (no gel) tubes at each timepoint.

Specimens will be separated for isolation of serum using routine methods of the clinical chemistry laboratory. Serum will be stored at -80 degrees C until batch measurements as described Measurements Biotin levels will be measured on each sample. Hormone measurements will be performed using specific commercially available streptavidin-biotin assays and using different analyzers as indicated below. Immunoassay methods, not employing biotin-streptavidin methodology, will be used for negative assay controls.

Eligibility Criteria:
Inclusion Criteria:

Healthy adults

Exclusion Criteria:

1. Pregnancy or lactation
2. Known thyroid disease (goiter, abnormal thyroid state),
3. Thyroid hormone treatment,
4. Over the counter dietary/ nutritional supplement use currently or within the last 2 weeks (excluding standard multivitamin preparations containing no more than 100% of the daily value for biotin and calcium),
5. Anticonvulsants,
6. Night shift work, smokers, adults lacking capacity to consent for themselves