cyrilzakka/clinical-trials huggingface dataset:
Diagnosis of Bladder Outlet Obstruction Using Dynamic Urine Vibration "Holter" in Comparison to Pressure Flow Study

Current gold standard of bladder outlet diagnosis is pressure flow study. This study is invasive time consuming and requires expensive and complex set-up. In this study the investigators plan to evaluate an alternative technology that presumably is able to diagnose bladder outlet obstruction using a Dynamic Urine Vibration "Holter" based on a Urine Flow Vibration Analysis technology. The acoustic vibration sensor is a small device that records the vibration due to urine flow. The patient attaches the sensor to the penis using a disposable sensor patch for the duration of approximately one minute during one urination. The analysis is performed off-line and the results are compared to the results of a standard pressure flow study. The innovative technology for the diagnosis of bladder outlet obstruction is noninvasive, rapid and does not involve complex setup.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of benign prostatic hyperplasia (BPH)
* has indication for urodynamic evaluation
Ambu® Auragain™ as a Conduit for Intubation in Paediatrics

This study will be conducted as a prospective observational study

This study will be done in any of the operating theatres of University Malaya Medical Centre

This study will involve paediatric cases ( ages 3-12 years )posted for elective operations which require general anaesthesia with endotracheal intubation

Ambu Aura Gain will be used as a conduit for intubation

All eligible participants will be approached and recruited Informed consent will be obtained Induction of general anesthesia will be as per usual standardized method Ambu® Auragain™ will be inserted A paediatric flexible endoscope will be used to view the glottis and railroad an endotracheal tube into the trachea Placement is confirmed and number of attempts and time required for successful intubation is recorded Ambu® Auragain™ will be removed Number of attempts and time taken for removal of Ambu® Auragain™ will be recorded Any complications will be noted and recorded

Eligibility Criteria:
Inclusion Criteria:

* Paediatric patients aged 3 - 12 years old
* American Society of Anaesthesiologist (ASA) 1-2 patients
* Patients must require standard endotracheal intubation for the procedure posted

Exclusion Criteria:

* Documented history of difficult airway in previous general anaesthesia
* Clinical features of difficult airway on physical examination
* Syndromic patients, facial deformities, dental deformities, patients with facial trauma
* Patients with recent (less than 2 weeks) or ongoing upper respiratory tract infection
* Patients with existing pulmonary diseases or any risk of bronchospasm
* Patients with known gastric outlet obstruction, reflux disease, or any risk of aspiration
* Any other contraindication for device placement
* Operations requiring specialised endotracheal tubes
* Emergency operations or unanticipated difficult airway cases
* Refusal of parental informed consent
A Randomized, Open-label Study on Helicobacter Pylori Eradication With Standard Triple Regimen Plus Acetazolamide

Helicobacter pylori infection is associated with several gastric diseases, including gastritis, peptic and duodenal ulcers, gastric carcinoma and MALToma. In 1994, the WHO classified the organism as a type 1 carcinogen. In order to eradicate H. pylori, at least two antibiotics and a proton pump inhibitor are used as a standard therapy regimen. Emerging antibiotic resistance to metronidazole or clarithromycin, however, has made successful treatment of infection progressively more difficult, with the success rate of standard triple therapy now at 70%, well below the 80% required for treatment of infectious diseases. Therefore, new treatment regimen is required for successful H. pylori eradication.

On the other hands, many in vitro studies revealed that bacterial carbonic anhydrase in H. pylori has an important role for surviving of H. pylori in the stomach. It was demonstrated that mutation of carbonic anhydrase affected survival of H. pylori. The investigators therefore expected that administration of carbonic anhydrase inhibitor (acetazolamide) with standard H. pylori eradication regimen would increase the eradication rate. Here, the investigators aim to evaluate the efficacy of standard triple regimen plus acetazolamide for H. pylori eradication.


Eligibility Criteria:
Inclusion Criteria:

1. Age, between 19 and 70
2. H. pylori infected patients

Exclusion Criteria:

1. Previous history of H. pylori eradication
2. Previous history of gastrectomy
3. Administration of PPI, H2 blocker, antibiotics, or bismuth within 1 month prior to enrollment
4. Allergy to sulfonamide
5. Electrolyte imbalance
6. Adrenal insufficiency
7. Pregnancy or breast milk feeding
8. Active infection
9. Severe hepatic dysfunction
10. Severe renal dysfunction
11. Severe bone marrow dysfunction
12. Significant neurologic or psychologic disease
Optimised Lung Cancer Screening to Prevent Cardiovascular and Pulmonary Diseases Coupled With Primary Prevention

This project aims to implement a health prevention program for smokers or former smokers including early detection of lung cancer, cardiovascular disease (CVD) and chronic obstructive pulmonary disease (COPD). The clinical activity is completed by a pre-clinical evaluation of molecular bio-markers of early diagnosis of these diseases, with the aim of strengthening the sensitivity and specificity of the screening program.

The project also includes a cost-effectiveness assessment to validate the feasibility of the program.

Since lung cancer, CVD and COPD are among the deadliest smoking-related pathologies, the program includes actions aimed at raising awareness among primary care physicians, increasing the smoking cessation rate of participating subjects to improve quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 55 years old and exposure to smoking more than 30 packs-year; which corresponds to 6-year risk of lung cancer, calculated according to the plco score (≥ 2%).
* Smoker or former smoker Former smokers must have ceased smoking within the 15 years prior to enrollment in the study.
* Absence of symptoms of lung cancer such as worsening of cough, hoarseness, hemoptysis and weight loss.

Exclusion Criteria:

* Previous diagnosis of lung cancer.
* Positive extrapulmonary cancer history in the last 5 years (excluding in situ tumors or skin epidermoid tumor).
* Performing a chest CT scan in the last 18 months.
* Severe lung or extrapulmonary diseases that may preclude or invalidate appropriate therapy in case of diagnosis of malignant pulmonary neoplasia.
A Study to Evaluate Non-significant Risk Operation Magnetic Resonance Imaging for MRI Guided Ablation

The result of these studies will be used to improve patient care through assessment of new technology to determine whether it is beneficial (i.e. improving data acquisition speed or image quality) during iMRI procedures.

This proposal includes evaluation of advanced MR imaging methods in the iMRI environment and will operate within the NSR guidelines for data acquisition established by the FDA/CDRH. The significant testing by vendor and Mayo staff prior to in vivo use, assure the safety of these studies and overall system stability.

The result of these studies will be used to improve patient care through assessment of new technology to determine whether it is beneficial (i.e. improving data acquisition speed or image quality) during iMRI procedures.

Eligibility Criteria:
Inclusion Criteria:

* Male or female.
* Age ≥ 18 years.
* Healthy volunteers or patients already scheduled for a MR-guided procedure.

Exclusion Criteria:

* Individuals 18 years of age.
* Pregnant women.
Fatty Acid Taste Thresholds: Caproic, Lauric, Oleic, Linoleic, Linolenic

Differences in human oral sensitivity for caproic, lauric, oleic, linoleic, and linolenic acids will be explored. Prior work indicates that there may be a learning effect in measuring detection thresholds for free fatty acids. This study is designed to determine the number of visits necessary to attenuate this learning effect and also to test whether this effect continues across different types of fatty acids or is specific to each fatty acid. This will aid in understanding how many visits are required to obtain reliable data and if less expensive fatty acids can be used to attenuate learning before testing thresholds for more expensive fatty acids.


Eligibility Criteria:
Inclusion Criteria:

* 18-60 years of age
* in good health
* available for 3 months

Exclusion Criteria:

* Participation in a different fat taste study in previous 6 months
MiCLASP Post Market Clinical Follow-Up (PMCF) Study

This is a postmarket clinical follow up study on the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System in transcatheter mitral valve repair.

The objectives of this clinical study are to collect data on the safety of the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System in transcatheter mitral valve repair and on the effectiveness of the Edwards PASCAL System and Edwards PASCAL Precision System in improving MR, functional status and quality of life in a post market setting.

Eligibility Criteria:
Inclusion Criteria:

1. Mitral TEER patients eligible per the current approved indication after Heart Team discussion and agreement
2. Patient is willing and able to attend all follow-up visits and to perform all tests
3. Provision of written informed consent

Exclusion Criteria:

1. Patients are not eligible per the current Instructions for Use
2. Non-elective or emergency TEER procedure for mitral regurgitation
3. Patients in ICU prior to the index procedure
Peritoneal Surface Malignancies - Characterization, Models and Treatment Strategies

The aim of this study is to identify biomarkers of disease recurrence and prognosis to optimize patient selection for treatment with cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC), and through animal models to explore different treatment strategies for peritoneal surface malignancies (PSM).

The handling of patients with PSM involves multimodal and multidisciplinary treatment strategies such as CRS, the removal of all macroscopically detectable tumor, and HIPEC, instillation of heated chemotherapy in the abdominal cavity to remove residual cancer disease. The treatment is challenging and complex and associated with significant morbidity. Only patients with limited disease will benefit from the treatment, and better methods for patient selection are needed. The project group has a unique opportunity to address key questions because of acquired experience, an exceptional biobank and institutional database and novel animal models established at the Norwegian Radium Hospital.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* confirmed diagnosis of peritoneal surface malignancy
* candidate for CRS-HIPEC
* written informed consent

Exclusion Criteria:

* none

Approximately 80 patients per year will be eligible for inclusion, as this is the number of patients that annually receive surgical treatment for PSM.
Pilot Study to Investigate the Effects of Increased Dialysate Magnesium and Dialysate Bicarbonate on the Calcification Propensity of Serum

The study aims to determine the effect size of magnesium and bicarbonate supplementation as a basis for future randomized controlled trials aiming at the T50-guided improvement of hard clinical endpoints in dialysis patients.


Eligibility Criteria:
Inclusion Criteria:

* Male or female hemodialysis patients ≥ 18 years of age
* Negative pregnancy test of female patients in child-bearing age
* The patients have to be able to understand the character and the individual impact of the clinical study and they have to give written informed consent to participate in the study
* Start of chronic hemodialysis treatment ≥ 3 months ago
* HCO3- in venous plasma ≤23 mmol/L before the start of the last dialysis of the week
* Magnesium in venous plasma ≤ 1.45 mmol/L before the start of the first dialysis of the week
* T50 ≥ 200 minutes.

Exclusion Criteria:

* Pregnant or lactating subjects. A blood pregnancy test will be performed at the screening visit in female patients of childbearing age.
* History of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or any history of drug abuse or addiction within 12 months of study enrolment
Long-Term Safety of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Pediatric Participants With Treatment-Resistant Childhood Absence Seizures

The primary purpose of this study is to assess the long-term safety and tolerability of Cannabidiol Oral Solution (CBD) in pediatric participants with treatment-resistant childhood absence seizures.


Eligibility Criteria:
Inclusion Criteria:

1. Completed all activities through Visit 6 (End of Study) of INS011-17-103.
2. Participant and/or parent(s)/caregiver(s) fully comprehend the informed consent form (ICF) and assent form, understand all study procedures, and can communicate satisfactorily with the investigator and study coordinator, in accordance with applicable laws, regulations, and local requirements.
3. A female participant is eligible to participate in the study if she is premenarchal, or of childbearing potential with a negative urine pregnancy test at the Screening Visit. If sexually active, she must agree to either complete abstinence from intercourse or use acceptable methods of contraception throughout the study and for 4 weeks after completion of study participation or discontinuation from investigational product.
4. A sexually active male participant or partner of enrolled participant must be willing to use acceptable methods of contraception throughout the study and for 4 weeks after completion of study participation or discontinuation from investigational product.
5. In the opinion of the investigator, the parent(s)/caregiver(s) is (are) willing and able to comply with the study procedures and visit schedules, including venipuncture, and the visit schedules.

Exclusion Criteria:

1. Participant or parent(s)/caregiver(s) have daily commitments during the study duration that would interfere with attending all study visits.
2. Experienced an anoxic episode related to study drug requiring resuscitation during their previous study.
3. Developed an adverse event thought to be related to CBD in the previous study and for whom the Investigator determines that continuing treatment with CBD would not be in the best interest of the participant.
4. Evidence of other clinically significant disease such as unstable hepatic, hematological, renal, cardiovascular, gastrointestinal, immunological, or pulmonary diseases or ongoing malignancies.
5. Compromised respiratory function or severe respiratory insufficiency.
6. Clinically significant abnormal laboratory values within the past 14 days.
7. In the opinion of the investigator, the participant is unsuitable in any other way to participate in this study.
Trial of H3B-6545, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer

The primary purpose of phase 1 portion of this study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of H3B-6545 in women with locally advanced or metastatic estrogen receptor (ER)-positive, human epidermal growth factor 2 (HER2)-negative breast cancer.

The primary purpose of phase 2 portion of this study is to estimate the efficacy of H3B-6545 in terms of best overall response rate, duration of response (DoR), clinical benefit rate (CBR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) in all participants with ER-positive, HER2-negative breast cancer and in those with and without ER alpha mutation (including a clonal estrogen receptor 1 gene \[ESR1\] Y537S mutation).


Eligibility Criteria:
Inclusion Criteria:

1. Pre- or post-menopausal women.
2. ER-positive, HER2-negative breast cancer that is advanced or metastatic.
3. Progressed on prior therapy. Multiple prior lines of therapy allowed in Phase 1 and 2. Participants under amendment 6 (or subsequent amendments) must have received prior cyclin-dependent kinase (CDK4/6) inhibitor therapy. Up to one prior chemotherapy in the metastatic setting is allowed.
4. A recent archival tumor tissue obtained within 6 months prior to enrollment or a fresh tumor biopsy must be provided. A second biopsy after initiating trial therapy is not required.
5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
6. Adequate bone marrow and organ function.
7. Participants under amendment 6 (or subsequent amendments) must have measurable disease at baseline as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
8. Participants under amendment 6 (or subsequent amendments) must have ESR1 Y537S mutation in absence of ESR1 D538G mutation as per the results of a central laboratory from a Nucleic Acids Whole Blood sample.

Exclusion Criteria:

1. Participants must have at least one measurable lesion.
2. Participant with inflammatory breast cancer.
3. Participant has received more than one prior chemotherapy regimen for metastatic disease (Phase 2 only).
4. Females of childbearing potential who are unable or unwilling to follow adequate contraceptive measures.
Emergency Department Triage of Patients With Acute Chest Pain Based on the ESC 0/1-hour Algorithm (PRESC1SE-MI)

The PRESC1SE-MI study compares two algorithms for triage of patients presenting with chest pain and symptoms of heart attack (myocardial infarction) to the emergency department. Both algorithms are recommended by the European Society of Cardiology: the 0/3-hour algorithm and the 0/1-hour algorithm.

Currently, most emergency departments worldwide use the 0/3-hour troponin algorithm. Cardiac troponin (cTn) is a heart-specific biomarker which indicates damage of the heart muscle and which increases after a heart attack. In the 0/3-hour algorithm, the amount of troponin in the bloodstream is measured with a high-sensitivity assay at admission and 3 hours thereafter. Likewise, the 0/1-hour algorithm means that the blood sample in which the troponin is measured is collected at admission and 1 hour later. Since recent clinical studies suggest that the 0/1-hour algorithm is superior to the 0/3-hour algorithm, many hospitals consider switching to the 0/1-hour algorithm.

The aim of this study is to assess how feasible the time-saving 0/1-hour algorithm would be in reality and whether it provides the same accuracy and safety in the diagnosis of myocardial infarction as the current practice the 0/3-hour algorithm.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 and above
* Presentation with acute non-traumatic acute chest pain to the emergency department
* Suspicion of acute myocardial infarction

Exclusion Criteria:

* Terminal kidney failure requiring dialysis
* Cardiac arrest
* Cardiogenic shock
Ketamine for Low Mood States in the ER

The investigators hope to see if a commonly used drug such as ketamine could help depressed ER patients feel better and improve their mood quickly.

Rapid-onset antidepressants could have important clinical impact if their benefits extended to Emergency Department (ED) patients. We hope to explore the preliminary feasibility, tolerability and efficacy of single-dose, intravenous (IV) ketamine in depressed ED patients who presented with suicide ideation (SI).

The manuscript (article) for this study has been retracted because Yale University conducted an investigation that determined that the description of the research was not accurate. The article misrepresents both the protocol-specified doses and the actual delivered doses of ketamine.

Eligibility Criteria:
Inclusion Criteria:

* adults (\>18yrs) presenting to the Emergency department with symptoms of depression and/or suicide ideation (MADRS\>30) with ability to give informed consent.
* medically stable

Exclusion Criteria:

* psychosis, bipolar, or other significant physical or mental illness
* pregnancy
* non-voluntary status
* urine drug screen positive for drugs of abuse
Management Strategies For Electrical Status Epilepticus During Sleep

Electrical status epilepticus during slow wave sleep is a condition in which the epileptic patient starts to develop neurocognitive deterioration, any type of seizures and continuous electrical activity in the EEG during non rapid eye movement sleep. It is an age related condition and will resolve spontaneously at around the age of puberty. However if left untreated or treatment is delayed, it may lead to permanent neurocognitive deterioration. Thus early diagnosis and treatment is essential in these children to preserve neurocognitive function.

Electrical status epilepticus in sleep (ESES), also known as continuous spikes and waves during slow sleep (CSWS), is an age related, self - limiting disorder characterized by:

1. epilepsy with different seizure types,
2. neuropsychological regression, and
3. typical EEG pattern of continuous epileptiform activity during non-rapid eye movement sleep (NREM).

During wakefulness, the EEG shows focal/multifocal spikes that increase in frequency during the acute stage. During sleep, ESES appears and is characterized by (1) marked potentiation of epileptiform discharges during non-REM sleep, leading to (2) a (near)-continuous, bilateral, or occasionally lateralized slow spikes and waves, (3) and these spikes and waves occur "during a significant proportion" of the non-REM sleep with a threshold ranging from 25% to 85%

The exact incidence of CSWS is not known. In pediatric neurology clinics, a reported frequency of 0.2% of childhood epilepsies most probably underestimates the incidence of CSWS.

CSWS is a devastating syndrome, which requires prompt treatment, the efficacy of which is checked with regular intervals, e.g. three or six months. Although epilepsy resolves with time in most cases, many children are left with significant cognitive or language impairment. Longer duration of ESES appears to be the major predictor of poor outcome.

So, early recognition and effective therapy are necessary to improve long-term prognosis in this condition.

The goal of treatment is not only to control clinical seizures but also to improve neuropsychological functions and prevent potential cognitive deterioration. There was no agreement on best treatment, but potential candidates included high-dose benzodiazepines, valproate, levetiracetam, and corticosteroids.

Eligibility Criteria:
Inclusion Criteria:

* All epileptic patients above 2 years of age presenting with neuropsychological deterioration, seizures and ESES in NREM sleep. The degree of epileptic activity during sleep will be measured and expressed as a spike wave index (SWI), which is defined as the total duration of continuous epileptic activity relative to total slow sleep duration. SWI must be at least 25% or more.

Exclusion Criteria:

* Any epileptic patient not presenting with typical EEG findings and neurocognitive regression.