cyrilzakka/clinical-trials huggingface dataset:
Efficacy of IV Acetaminophen Versus Oral Acetaminophen

The aim of this study is to determine whether intravenous acetaminophen compared to enteric acetaminophen offers increased efficacy in patients who are scheduled for laparoscopic donor nephrectomy and for patients scheduled for robot-assisted, laparoscopic nephrectomy for cancer at the University of Rochester Medical Center. The standard surgical and post-operative care, including post-operative pain management will not be altered.


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years old
* Be scheduled for donor nephrectomy or robot-assisted, laparoscopic nephrectomy for cancer at University of Rochester Medical Center
* Have cognitive ability to verbally rate their pain on the Numeric Rating Scale (NRS).

Exclusion Criteria:

* Age younger than 18 years old or older than 90 years old
* Pregnancy (Pre-operative pregnancy test is standard of care for all elective operating room cases)
* Weight less than 50 kg
* Epidural use
* History of known liver disease.
* Patient unable to take enteral medications.
* Be taking opioid medications chronically.
Single Versus Repeated Piezocision-assisted Orthodontic Tooth Movement

The primary aim of the study is to evaluate the effect of single and repeated piezocisions on the rate of orthodontic tooth movement. Secondary aims are to evaluate the effect of both protocols on molar anchorage loss, as well as on canine root resorption.


Eligibility Criteria:
Inclusion Criteria:

* Malocclusion that requires at least the extraction of maxillary first premolars, such as Class I bimaxillary protrusion, and Class II division 1 cases.
* Normal shape and structure of the maxillary canines, with no history of root canal treatment

Exclusion Criteria:

* Patients who underwent previous orthodontic treatment.
* Patients currently receiving drug therapy that may affect orthodontic tooth movement, e.g. hormonal therapy and corticosteroids.
Can Veinlite Reduce Complications of Peripheral Intravenous Catheter Placement in Children

This study was conducted to investigate the use of Veinlite LED+ (TransLite, Sugar Land, Tex) to assist with PIC placement. The Veinlite uses LED (light-emitting diode) lights to enhance the visualization of veins by using orange and red color that are absorbed in venous blood.

The investigators' hypothesis for this study was that the vein imaging would reduce the complications related to catheter and the pain that the participants would feel.

Peripheral Intravenous Catheterization (PIC) introduces multiple risks and potential morbidities. Patients with PIC-associated complications have longer length of stay, higher clinical and economic burden, and greater risk of death than patients without. The most serious complications due to intravenous (IV) catheters are infiltration and extravasation.

The primary endpoint was to evaluate whether Veinlite LED+ would prevent catheter-related complications.

The secondary endpoint were;

1. to evaluate the efficacy of the vein imaging device on pediatric pain during intravenous catheterization
2. to evaluate the efficacy of the vein imaging device on catheter dwell time.

Eligibility Criteria:
Inclusion Criteria:

* Children aged between 5 and 18
* Children with DIVA (Difficult intravenous access score) score 4 or more
* That the child and the parent speak Turkish

Exclusion Criteria:

* needing urgent treatment
* a critical health condition
* That the child or the parent has a communication problem
Peripheral Blood DNA Methylation Markers for the Early Detection of Colorectal Carcinoma in the Egyptian Population

The incidence of colorectal cancer (CRC) is on the rise on a global scale. The number of cancer-related deaths related to CRC is also rising to an alarming level. This picture is similarly seen in Egypt where the incidence of colorectal carcinoma is increasing annually, moreover, CRC in Egypt exhibits an alarming characteristic which is the affection of much younger patients than their counterparts worldwide. Fortunately, the early detection of CRC and its precursor (adenoma) has been shown to markedly decrease morbidity and mortality related to this tumor, this has prompted the development of robust screening programs for CRC in several western countries. The implementation of a CRC screening program in Egypt has been hampered by the low compliance of the patients and the relatively high cost of colonoscopy. There is a need for an affordable, non-invasive, simple, accurate and socially accepted screening test to allow such a program to succeed in Egypt. Recent studies have shown that DNA is the future target of screening tests for several malignancies. Particularly for CRC a few preliminary studies have shown encouraging results with separate DNA methylation markers both in blood and stool. In our efforts to develop a screening test with the criteria stated above, the investigators have decided to join the forces of 2 of the largest medical centers in Egypt and the middle-east: Kasr-Alaini hospital and the National cancer institute (NCI). The investigators plan to test a panel of 7 DNA methylation markers in peripheral blood for their performance as an early marker for CRC and colorectal adenomas. Data from this study will pave the way for the development of a screening test for CRC "tailored" to the Egyptian population, moreover, it will supply essential data about the genetic alterations occurring in CRC in Egyptian patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing colonoscopy as part of their clinical care or part of screening program.
* Complete endoscopic examination (up to the caecum)
* Adequate colonic preparation

Exclusion Criteria:

* - Incomplete colonoscopic examination due to technical causes e.g. difficult colonoscopy, patient intolerance (N.B. a neoplastic mass causing lumen stenosis will not be excluded.)
* Poor colonic preparation obscuring adequate mucosal examination.
* Patients who have received any treatment for CRC and/or adenomas.
* Patients with known malignancy elsewhere (i.e. non-colorectal malignancy)
Neuronal Ceroid Lipofuscinosis and Associated Sleep Abnormalities

Neuronal Ceroid Lipofuscinosis (NCL) also known at Batten's disease is the most common neurodegenerative disorder in children. Families often report the patient has a sleep disturbance. This is a questionnaire to be completed by the family to better understand the sleep pattern and sleep difficulties experienced by individuals who have been diagnosed with NCL.

Neuronal Ceroid Lipofuscinosis (NCL) is the most common neurodegenerative disorder in children characterized by seizures, blindness, ataxia, myoclonia and loss of cognition. There are 12 clinical types identified with a concurrent genetic abnormality. The diagnosis is determined by gene testing and skin biopsy findings although genetic testing has supplanted skin biopsy in most cases. Numberous studies have confirmed the presence of sleep disorder in patients with NCL but these cases were documented over a decade ago. The investigators would like to study the prevalence of sleep disorders in this group of patients. The investigators will distribute a Children's Sleep Habits Questionnaire (CSHQ) to the family of the patient to complete and provide a information regarding the patient's sleep. In addition to the validated sleep questionnaire a separate demographic questionnaire will be given to the family to identify the type of NCL, presence or absence of blindness, presence or absence of seizures, interventions tried to treat sleep disturbance. The last questions of the study are asking for the presence or absence of Restless Leg Syndrome symptoms.

Eligibility Criteria:
Inclusion Criteria:

* patient with a known diagnosis of Neuronal Ceroid Lipofuscinosis (NCL) by DNA or electron microscopy studies Family member completing study must be able to read and understand the Children's Sleep Habits Questionnaire (CSHQ) and Demographic questions

Exclusion Criteria:

* patient without a confirmed diagnosis of NCL Family member completing the study is unable to read and understand the questionnaires
A Study to Characterize the Clinical Course of Pregnant Women and Children at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn

The primary purpose of the study is to characterize the current standard of care, clinical course, and outcomes of pregnant women and their offspring at high risk for early onset severe hemolytic disease of the fetus and newborn (EOS-HDFN).

The outcomes of interest will be assessed from the information collected on the standard of care treatment for EOS-HDFN in pregnant women and their offspring from current pregnancy.

Eligibility Criteria:
Pregnant female participants must be ≥18 years of age with an estimated Gestational Age of ≥ 8 weeks; not currently pregnant with multiples (twins or more); and no other clinically relevant abnormalities currently or in their history that the Investigator would deem them ineligible to participate.
Normothermia in Patients With Acute Cerebral Damage

The purpose of our study is to verify wherever normothermia (achieved with diclofenac administration) may improve intracranial pressure control and may limit secondary cerebral damage thus positively influencing outcome in patients with acute cerebral damage admitted to ICU.

Pyrexia can exacerbate ischemic neuronal damage and physiological dysfunction after traumatic brain injury and subarachnoid hemorrhage.Fever also represent an important issue occurring in 78% of patients with acute cerebral damage admitted to intensive care unit (ICU). For those patients, normothermia is actually recommended in order to reduce secondary cerebral damage and to control intracranial pressure, that are known to worsen long term prognosis. Our primary endpoint is to maintain normothermia in patients with acute cerebral damage (axillary temperature \< 38°C or internal temperature \< 38,8°C) administering diclofenac. We will also investigate the corresponding behaviour of intracranial pressure and cerebral perfusion pressure.

Comparison(s): We will compare two different doses of subcutaneous diclofenac (0,35 mg/kg - 1/3 a vial - vs 0,5 mg/Kg - 1/2 vial) to continuous intravenous of 0,48 mg/kg diclofenac for 12 hours.

Eligibility Criteria:
Inclusion Criteria:

* Patients with severe traumatic injury or subarachnoid hemorrhage in coma (GCS\<8), intubated, mechanically ventilated with intracranial pressure (ICP) and invasive arterial pressure monitoring

Exclusion Criteria:

* Know adverse reactions with NSAI
* Platelets count \< 20,000/dl
* Gastric or duodenal ulceration in active phase
* Hepatic insufficiency, cirrhosis or previous liver transplant
* Acute or chronic renal insufficiency
* Coronary insufficiency, acute myocardial infarct in the previous 6 month
* Barbiturate coma
* Patients in therapy with acetylsalicylic acid, lithium, digoxin, methotrexate and cyclosporin.
* Known or suspected pregnancy
Biomarkers in the Nose, Throat, and Lung Tissue of Smokers and Non-Smokers

RATIONALE: Studying samples of tissue from smokers and non-smokers in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

PURPOSE: This phase II study is looking at biomarkers in the nose, throat, and lung tissue of smokers and non-smokers.

OBJECTIVES:

Primary

* Define the molecular and biochemical profiles of airway epithelium of smokers with no disease, smokers with airflow obstruction and abnormal sputum cytology, and non-smokers.

Secondary

* Assess the occurrence of abnormalities in non-smokers, smokers with no disease, smokers with various grades of dysplasia, and smokers with lung cancer.

OUTLINE: Patients are stratified according to smoking status (smoker vs non-smoker) and disease (no disease vs airflow obstruction and abnormal sputum cytology vs various grades of dysplasia vs lung cancer).

Biological samples are collected and analyzed for future research studies.

PROJECTED ACCRUAL: A total of 78 patients will be accrued for this study.

Eligibility Criteria:
Inclusion Criteria:

1. - Adults \> 45 years of age, to be age matched with a previously enrolled cohort of current and ex-smokers with airflow obstruction and moderate atypia on sputum cytology, to be included in the following groups.
2. - Non-smoking (less than 100 cigarettes per lifetime) controls \>50 years of age, to be age matched with a previously enrolled cohort with airflow obstruction (FEV1 \< 75% predicted and FEV1/FVC \< 75%) and moderate atypia on sputum cytology.
3. - Current smokers with \> 30 pack years, no airflow obstruction (FEV1 \> 90% predicted) or lung cancer, \>50 years of age, to be age matched with a previously enrolled cohort with airflow obstruction and moderate atypia on sputum cytology .
4. - No prior history of a head and neck or bronchogenic carcinoma.
5. - Patients must be fully informed of the investigational nature of this study and must sign an informed consent in accordance with institutional and FDA guidelines.

Exclusion Criteria:

1. - Clinically apparent bleeding diathesis.
2. - Cardiac dysrhythmia that is potentially life-threatening, such as ventricular tachycardia, multifocal premature ventricular contractions or supraventricular tachycardias with a rapid ventricular response. Well-controlled atrial fibrillation or rare (\< 2/minute) premature ventricular contractions are not exclusionary.
3. - Hypoxemia (less than 90% saturation with supplemental oxygen) during bronchoscopy.
4. - Evidence of clinically active coronary artery disease, including myocardial infarction within 6 weeks, chest pain, or poorly controlled congestive heart failure, or any other serious medical condition which would preclude a patient from undergoing a bronchoscopy.
5. - Acute bronchitis or pneumonia within 8 weeks.
6. - Inability to give informed consent.
7. - Current smokers with no airflow obstruction may not have a history of coughing more than two times /week.
Psychological Skill Training for Athletes

The investigator will determine the effectiveness of psychological skill training on quantitative EEG in athletes before the competition.

Psychological skills training is the mental training that can apply for increased athletes' performance to make athletes more confident. The objective of psychological skill training is to develop the potential of athletes to be able to show their abilities (Peak Performance), and to create satisfaction, self-esteem, for athletes. Additionally, the ability to concentrate and reduce anxiety could affect athletes' emotions and be ready to participate in the competition. Therefore, this study will apply psychological skills training for athletes. The effectiveness of psychological skill training will be measured by using quantitative EEG before and after training. The quantitative EEG assessments could demonstrate an anxiety level at different stages of the competition and it could reveal the changes caused by training. The intervention will begin 3 months before the competition. The quantitative EEG measurements are arranged 4-5 times following the previous study. The sequence of the measurement will be including a baseline: one month before the competition, two weeks before the competition, a week before the match, three days before the match (depend on the situation), three days after the match (post-training).

Eligibility Criteria:
Inclusion Criteria:

* Athletes male or female
* Age between 18-35

Exclusion Criteria:

* Having an acute injury to the musculoskeletal structures of other joints of the lower extremity in the previous 3 months
A Study of the Safety and Efficacy of Microplasmin to Induce a Posterior Vitreous Detachment (MIVI III)

A multicenter study to compare multiple doses of intravitreal microplasmin in patients undergoing surgical vitrectomy.


Eligibility Criteria:
Inclusion Criteria:

* Patients in whom vitrectomy is indicated

Exclusion Criteria:

* Posterior Vitreous Detachment (PVD) present at baseline
* Vitreous hemorrhage
* Certain vitreoretinal conditions including proliferative disease, rhegmatogenous retinal detachment, and proliferative vitreoretinopathy (PVR)
* Have had a vitrectomy in the study eye at any time
Unipolar or Bipolar Hemiarthroplasty in the Treatment of Displaced Femoral Neck Fractures.

Hemiarthroplasty of the hip is standard treatment of femoral neck fractures (hip fractures). Hemiarthroplasty means replacing the hip joint with a metal prosthesis. Unipolar prostheses has a one-piece design where the hip movement occurs between the prosthesis and the acetabulum (hip socket). A bipolar prosthesis has an additional artificial joint between the two components of the prosthesis. Both treatments are clinically proven and common around the world. No clinical trial has proven benefits of one or the other prosthesis design. The investigators want to measure the differences in acetabular wear using these two prostheses, using radiostereometric measurements.

Patients 70 years or older presenting to our hospital with an acute femoral neck fracture are eligible for inclusion. 15 patients in each group will be recruited. One group receives a unipolar hemiarthroplasty and 15 receives a bipolar arthroplasty. Tantalum markers are placed around the acetabulum during surgery. Follow-up intervals are at 3, 12 and 24 months with radiostereometric evaluation (radiographs) and clinical evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Displaced femoral neck fracture
* 70 years or older
* Ambulatory status: No walking aids
* No mental illness or impaired cognitive function

Exclusion Criteria:

* Pathological fracture (malignant disease)
* Ongoing systemic or local infection
* Radiologically presence of acetabular wear (osteoarthrosis)
Augmented Reality and Treadmill Training After Traumatic Brain Injury

Up to 40 participants will be enrolled in this study in order to obtain complete data on 30 participants. The investigators will be assessing if Augmented reality in combination with treadmill training is safe and feasible to use in the clinical environment with participants who have chronic TBI and if there is a signal of effect that this intervention may be more beneficial than treadmill training alone or standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Sustained a TBI requiring inpatient rehabilitation
* \> 1 year post TBI
* 18-65 years of age
* Not currently participating in any other research study to address balance and gait impairment
* Not currently participating in physical therapy
* Ambulates with minimal assistance and/or assistive device
* Self-report of ongoing balance deficits and mobility deficits
* Score of 75 or below on CB\&M
* No history of other neurological disorders affecting balance
* No seizures within the last year
* No history of psychiatric disorder requiring hospitalization
* Ability to follow directions and complete standardized instructions

Exclusion Criteria:

- No pregnant or lactating females (Potential female participants will be informed that risks to pregnant or lactating females are unknown; then they will be asked if they are pregnant or lactating, or if they could be pregnant. If there is any uncertainty, they will not be included in the study).
Parecoxib for Treatment of Catheter Related Bladder Discomfort

Catheter-related bladder discomfort (CRBD) is defined as an urge to void or discomfort in the supra-pubic region; reported postoperatively in patients who have had urinary catheterization intra-operatively. In the present study, the investigators evaluated Parecoxib (P) for preventing CRBD in patients undergoing catheterization after transurethral resection of bladder tumor (TURBT).

Participants will be randomized into one of two study groups: Group P: 40 mg of intravenous parecoxib 30 min before surgery and Control Group C: an equal volume of saline.

Lumber subarachnoid block was administered with 2 ml 0.5% hyperbaric bupivacaine and 2.5 µg Sufentanyl. Intra-operatively, urinary catherization was performed with a 16 Fr Foley's catheter, and the balloon was inflated with 10 ml distilled water. The CRBD was assessed at 0, 1, 2, and 6 h after patient's arrival in the post-anaesthesia care unit. Severity of CRBD was graded as none, mild, moderate and severe.

Eligibility Criteria:
Inclusion Criteria:

1. Adult (\>/=18)
2. Male or female
3. Undergoing catheterization after transurethral resection of bladder tumor (TURBT)
4. Under spinal anesthesia
5. Subject is American Society of Anesthesiologists (ASA) physical status 1 or 2.

Exclusion Criteria:

1. Patient who disagrees to participate this investigation
2. Patient with severe cardiovascular disease
3. Patient with small-sized foley catheter (less than 18 Fr.)
4. Patinets with bladder outflow obstruction
5. Patient with overactive bladder (frequency \>3 times,in the night or \>8 times in 24 h)
6. Patients with chronic renal failure
7. Patient with morbid obesity
8. Patient with medications for chronic pain
9. Patient with disturbance of the central nervous system
Determination of Prevalence and Features of HRRm mCRPC (ADAM)

Study design:

This study is local, multi-center, prospective, cohort study to collect real world data related mCRPC patients, prevalence of HRRm and to assess possible influence of HRRm on treatment outcomes. No additional procedures besides those already used in the routine clinical practice will be applied to the patients. Treatment assignment will be done according to the current practice.

Data Source(s):

For testing archival samples (formalin fixed and paraffin embedded \[FFPE\]) from primary tumor will be used . 15 HRR genes (BRCA1, BRCA2, ATM, BRIP1, BARD1, CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D and RAD54L) will be analyzed using NGS in dedicated central laboratory facilities. Choice of laboratory for each center will be made based on logistical proximity. Each NGS laboratory will have to determine and report clinical significance of alterations found using database search or other predictors to classify variants as deleterious or suspected deleterious. VUS have to be reported separately. Benign variants will be not reported in this study.

All clinical and demographic data for patients with finished therapy will be collected in prospective or retrospective (where applicable) manner during the study visits. The second visit will take place when the disease progression or death is occurs or in a year after the first visit whichever happens first. Data will be entered in the eCRF. The site investigator will be responsible for ensuring that all required data is collected and entered into the eCRF with the involvement of clinical research organization.

It is estimated that approximately 300 patients will be enrolled in the first stage. After interim analysis total number of the patients can be increased, depending on the number of NGS failures. It is estimated that approximately 30 sites in total will be participating in the study.


Eligibility Criteria:
Inclusion Criteria:

* Male 18 years age or older
* Provision of written informed consent
* Histologically confirmed diagnosis of prostate cancer
* Documented evidence of metastatic castration resistant prostate cancer (mCRPC)
* Patients who are on the first line therapy or already received one line of therapy due to mCRPC previously
* Availability of archival FFPE tissue from primary prostate tumor
* Availability of medical history (e.g. out-patient medical records or disease histories for hospitalized patients)

Exclusion Criteria:

• Patients participating in clinical studies