cyrilzakka/clinical-trials huggingface dataset:
Biomarkers in Different Types of Amyotrophic Lateral Sclerosis (ALS) Patients Being Treated With Edaravone

This study is being conducted to help the investigators better understand how the new FDA approved medication Edaravone (also known as Radicava) works in subsets of patients with ALS. The investigators are also trying to understand if there are specific ALS patients, with different presentations of ALS, who might benefit most from this medication. Also, the investigators are following specific biomarkers to determine the optimal treatment duration in patients with different forms of ALS

There is no study medication being offered in this trial. Edaravone is prescribed as part of regular care. In this trial we are collecting blood, urine, and spinal fluid samples in ALS patients who are taking Edaravone and ALS patients who are not taking Edaravone to measure certain markers that could indicate why the drug may be working in a specific type of ALS.


Eligibility Criteria:
Inclusion Criteria:

1. Either possible, probable, or definite ALS, predominantly lower motor neuron disease, predominantly upper motor neuron disease, or bulbar
2. With or without cognitive involvement
3. Willing to participate
4. On no experimental treatment
5. Ages 18 - 85
6. No prior exposure to Edaravone (Radicava)
7. On a stable dose of Riluzole for 30 days or off Riluzole
8. Male or female
9. Females of childbearing age must use contraception

Exclusion Criteria:

1. Unstable medical illness
2. Abnormal liver function (\>2x ULN)
3. Unlikely to survive for 26 weeks
CTCs and Novel Target Bio-marker Analysis for Prediction and Monitoring of Metastasis/Recurrence in Post-surgery Colorectal Cancer Patients Using MiSelect R Rare Cell System

Despite the growing public awareness and recent progress in multimodality therapy to the colorectal cancer (CRC), CRC still ranks high on the list of the most common and deadly cancers in Taiwan. The cause of CRC mortality is due mainly to the occurrence of distant metastasis. Several reports suggested that circulating tumor cells (CTCs) highly associated with metastasis suggesting that targeting CTCs may offer an unprecedented opportunity to prevent the development of metastasis. Early detection and characterization of CTCs is therefore important as a potential strategy to monitor the progression of CRC. The current proposal is focused on detecting CTCs from peripheral blood of CRC patients using Miselect R system. We will monitor the amount of CTCs and correlate with CRC progression and prognosis.


Eligibility Criteria:
Inclusion Criteria:

1. Over 20 and less than 90 years of age.
2. Colorectal cancer stage II/III patients who will undergo surgical resection.
3. Subject having agreed to participate in the study and follow the study procedures by providing written informed consent prior entering the study.

Exclusion Criteria:

1. Have other cancer history.
2. Subject being identified with any blood borne infectious disease
A Comparison of Sequential Compression Devices and Foot Pumps in the Obstetric Population

The researchers at Johns Hopkins University believe that the foot pump will be superior to sequential compression devices in comfort and patient compliance which may increase provider efforts to prevent deep vein thrombosis (DVT) in pregnancy.

The investigators will be comparing sequential compression devices (SCDs) to foot pumps to determine if foot pumps will be better tolerated by obstetric patients, both antepartum and intrapartum. Patients in whom thromboembolic prophylaxis is deemed necessary and ordered by the treating physician, who agree to participate in the study will be randomly assigned to receive SCDs or the foot pump as part of their thromboembolic prophylaxis regimen. The investigators will administer a questionnaire to assess patients' satisfaction and comfort with each device and they will be asked to complete a log of hours they wore their assigned device for a 7 day period (or as long as they are prescribed). Random spot checks to verify compliance will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant
* Bedrest
* Thrombophilia
* Prescribed DVT prophylaxis

Exclusion Criteria:

* Active DVT
Paravertebral Block (PVB) Combined Pectoral Musculature Blocks for Modified Radical Mastectomy (MRM)

Previous studies have shown that PVB reduces pain and postoperative nausea and vomiting after breast cancer surgery when used in addition to general anesthesia or sedation. However, major breast cancer surgery involves areas beyond the breast tissue, such as pectoral musculature.


Eligibility Criteria:
Inclusion Criteria:

* The American Society of Anesthesiologists (ASA) Physical Status classification I to III
* 20 - 75 years of age
* female gender

Exclusion Criteria:

* body mass index (BMI) ≥ 35 kg/m2
* modified radical mastectomy not performed by the single surgeon (Ben Long Yu)
* anesthesia not performed by the single anesthesiologist (Nai Liang Li)
Asymmetrical Directionality With Bimodal Systems.

Research supports that bimodal stimulation includes improvements in auditory performance and daily living over using a cochlear implant (CI) or hearing aid (HA) alone. Although bimodal users continue to achieve high levels of satisfaction, speech perception in noise continues to be highly problematic. The aim of this field study is to identify which directionality schemes in a bimodal solution are preferred by users using an ecological momentary assessment tool.

The primary purpose of this research trial is to evaluate asymmetrical directionality in bimodal users for hearing speech in noise in the sound field and in daily life using an EMA tool. The aim is to collect information regarding hearing for speech in background noise as well as end-user insights, testimonials, and communication content.

Eligibility Criteria:
Inclusion Criteria:

Subjects must meet the inclusion criteria described below to be eligible for this clinical investigation.

1. Adults who are English speaking and aged 18 years and older.
2. Individuals with a mild sloping to severe/profound hearing loss in the hearing aided ear.
3. New and experienced bimodal users (cochlear implant + hearing aid).
4. Experienced Nucleus 7 or Kanso 2 cochlear implant users with minimum experience using electrical hearing for 6 months.
5. Individuals able to complete test measures as outlined in the informed consent and protocol.
6. Individuals with access to a Smart Phone/device that is either iOS 7.0 or Android 4.0 and later who are willing to utilize their personal Smart Phone/device for participation in the trial.
7. Individuals willing to use their personal email account for participation in the trial.

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Exclusion Criteria:

Subjects who meet any of the exclusion criteria described below will not be eligible for this clinical investigation.

1. Individuals using sound processors in the Hybrid mode.
2. Bilateral cochlear implant users.
3. Unable or unwilling to comply with the requirements of the study as determined by the Investigator.
4. Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
5. Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational device.

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Pharmacokinetic Study on Echinocandins for Patients With Septic Shock Following Secondary Peritonitis

The main objective of this study is to describe the pharmacokinetics of the prescribed echinocandins for septic shock with secondary peritonitis for which intra-abdominal fungal infection is suspected or proven.

The secondary objectives of this study are:

* Determine whether the current recommended doses of caspofungin achieve the Pharmacokinetic/Pharmacodynamic (PK/PD) target for this molecule.
* Determine whether the current recommended doses of micafungin achieve the PK / PD target for this molecule
* Describe the peritoneal concentrations of echinocandins in secondary peritonitis complicated with septic shock
* Identify via modeling PK / PD parameters and based on monte Carlo simulations the optimal dosing regimen for caspofungin and micafungin in this population

Eligibility Criteria:
Inclusion Criteria:

* The emergency inclusion procedure was correctly applied according to French law (signature of consent form by a patient-designated trusted person or a family member, or a medical decision to proceed with patient inclusion if the latter two persons are unavailable) ---- OR ---- signature of the consent form by the patient
* The patient must be insured or beneficiary of a health insurance plan
* The patient is 18 years of age or older
* The patient has beed admitted to the ICU for septic shock accompanying secondary peritonitis
* Patient requiring antifungal treatment via echinocandins (caspofungin or micafungin)
* A venous or arterial access for blood sampling is already in place for routine care

Exclusion Criteria:

* The patient is participating in an interventional study that may affect the results of the present study, or has participated in such a study within the past 3 months
* The patient is under judicial protection, or is an adult under guardianship
* The patient is pregnant, parturient or breastfeeding
* Moribund patient
* Known positive serology for human immunodeficiency virus (HIV)
* Known positive serology for hepatitis C
* Known diagnosis for tuberculosis
A Single Ascending Dose Study Examining the Safety and Pharmacokinetic Profile of Reconstituted High Density Lipoprotein (CSL112) Administered to Patients

Reconstituted high density lipoprotein used in patients with acute coronary syndrome (ACS) may reduce atherosclerotic plaque burden, thereby reducing the risk of recurrent cardiovascular events. This study is a multi-center, randomized, placebo-controlled, single ascending dose study in patients with stable atherothrombotic disease in whom the safety and pharmacokinetic profile of CSL112 will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 years to 80 years.
* Subjects must have documented evidence of a history of atherosclerotic coronary artery disease/surgical revascularization.
* Subjects on a stable medication regimen.
* Body weight 50 kg or greater at screening.

Exclusion Criteria:

* Moderate/severe heart failure or renal impairment.
* Uncontrolled hyperglycemia in subjects with type 1 or type 2 diabetes.
* Receipt of the combination of omeprazole and clopidogrel within 1 month of randomization.
* Subjects whose medical history, condition or medication regimen may interfere with the evaluation of the safety and tolerability of CSL112 (for example significantly altered electrocardiogram (ECG) waveform, hepatobiliary disease, malignancy, thrombocytopenia, etc.)
* Known hypersensitivity to the product components
Sleep Disorders and Gastroesophageal Reflux Disease (GERD)

This study will investigate Gastroesophageal Reflux Disease (GERD)as a cause of sleep disturbance. Patients with GERD may experience all or some of the following symptoms: stomach acid or partially digested food re-entering the esophagus (which is sometimes referred to as heartburn or regurgitation) and belching. Even very small, unnoticeable amounts of rising stomach acid may cause patients to wake up during the night.

This study will also investigate the effect of Rabeprazole, (brand name Aciphex) on patients with known insomnia. Rabeprazole is an FDA approved medication already marketed for the treatment of GERD.

Participants with known insomnia will undergo an overnight pH and sleep study. Those found to be eligible after the first sleep study (those with significantly poor sleep quality and no significant sleep apnea) will be started on 2 weeks 20 mgs, twice-a-day, rabeprazole. Upon completion of the 2 week course of rabeprazole, subjects will repeat the overnight pH and sleep studies. Upon completion of these studies, participation is complete.

Eligibility Criteria:
Inclusion Criteria:

1. English-speaking male or female subjects, 18-75 years of age. (Women must be two (2) years post-menopausal or surgically sterile. Women of childbearing potential or \<1 year post-menopausal must be practicing an approved method of contraception and have a negative urine pregnancy test at screening.),
2. a six-month duration of insomnia,
3. sleep difficulty at least 3 nights per week, and a sleep study demonstrating \> 10 arousals/hour for those aged \< 45, and \>15 for those who are 45 or older.

Exclusion Criteria:

1. BMI \> 30 or history of snoring (in order to decrease the prevalence of sleep apnea in the sample),
2. use of any proton pump inhibitor or H2 receptor antagonist within one week of undergoing initial sleep study,
3. previous acid-suppressing medication for sleep disturbances,
4. previous surgical antireflux procedure,
5. current medical therapy that includes digoxin or ketoconazole,
6. previous aerodigestive malignancy,
7. a previously diagnosed psychological or medical cause of insomnia (other than suspected GERD), and
8. inability or unwillingness to provide consent for the procedures.
Autoantibodies Against Human Recombinant Erythropoietin in Myelodysplatic Syndrome Patients

The purpose of this study is to verify the presents of autoantibodies in serums of MDS serum patients who had an inadequate response or did not respond to Recombinant human erythropoietin (rHuEPO) treatment.

MDS are a heterogeneous group of hematologic disorders broadly characterized by cytopenias associated with a dimorphic and usually cellular bone marrow, and by consequent ineffective blood cell production. 85% of patients have a severe anemia which is Associated with lowering quality of life and Often requires blood transfusions. Historically, only stem cell transplantation offers cure. however, multiple new drugs have been approved for treatment, such as to Recombinant human erythropoietin (rHuEPO) treatment for dealing with the anemia. rHuEPO treatment can improve hematocrit level in 25% of patient which leaves the rest with the need of other treatment solution. Studies have shown presents of anti- rHuEPO in blood serums which followed Treatment of other diseases. These findings can indicate the possibility of the presence of antibodies in MDS patients as well.

Eligibility Criteria:
Inclusion Criteria:

* Followed up hematological patients
* Pateint recieving rHuEPO treatment (except control group)
* Pateint signed informed consent

Exclusion Criteria:

* None
The Role of FAPI PET-CT in Diagnosing Endometriosis

Patients with suspected endometriosis scheduled for surgery will be identified. They will be asked to participate in a study evaluating the feasibility of FAPI PET-CT in diagnosing endometriosis. The results will be compared with surgical findings, pathology, and other imaging techniques if available (i.e., MRI, US).

This study investigates FAPI PET-CT imaging in endometriosis diagnosis using a standardized protocol. Participants will undergo two imaging sessions after a single FAPI injection:

First Session:

Initial scan at 10 minutes post-injection Follow-up scan at 30 minutes

Second Session:

Additional scans at 60 and 80 minutes post-injection

The protocol is designed to minimize radiation exposure through:

Single FAPI injection Two ultra-low dose CT scans Limited field of view to suspected areas. Nuclear medicine physicians will review PET-CT images independently, blinded to other imaging findings (MRI, US). Results will be shared with surgeons to guide the removal of suspicious lesions during surgery. All removed tissue will undergo pathological examination for confirmation.

The study incorporates safety monitoring:

Observation during and after FAPI administration Follow-up contact at 24-48 hours post-scan Documentation of any adverse events Immediate reporting of unexpected findings. This research could potentially provide evidence for a novel, non-invasive method to comprehensively map endometriotic lesions, improving pre-operative planning.

Eligibility Criteria:
Inclusion Criteria:

* Female participants aged 18-45 years
* Clinical suspicion of endometriosis based on symptoms
* Scheduled for diagnostic/therapeutic laparoscopic surgery
* Ability to understand and provide written informed consent
* Completed and signed Radiation Exposure Documentation Form

Exclusion Criteria:

* Pregnant women or women who are breastfeeding
* History of pelvic radiation therapy
* Known active malignancy
* Exposure to ionizing radiation for medical purposes within 12 months prior to enrollment
Brain Imaging, Heart Rate Variability and Serum Fatty Acid in Subjects With Irritable Bowel Syndrome

This study is to analyze the relationship between brain structure, the heart rate variability and the serum fatty acid component of the irritable bowel syndrome patients.

Several studies showed that the gray matter and white matter of the brain related to the symptoms of irritable bowel syndrome patients.

The investigators study is to analyse the relationship between thickness of cortex of irritable patients, the sympathetic tone and the serum fatty acid component of the irritable bowel syndrome patients. It is to clarify the mechanism of irritable bowel syndrome, whether the symptoms of irritable bowel syndrome are related to the thickness of cortex or inflammation status of the body.

Eligibility Criteria:
Inclusion Criteria:

* female
* between 20 and 50 years old
* meet Rome III criteria

Exclusion Criteria:

* colon and small intestinal disease
* psychiatric disease patients
* patients received major surgery in the past 5 years
* diabetic patients
* patients with metal implant
Sodium Awareness in Lactation Trial

SALT is a multi-centre, non-blinded, non-randomized prospective interventional pilot study teaching lactating parents of hospitalized preterm infants how to test their breastmilk sodium (Na) using point-of-care (POC) meters. A drop in Na is a sign of secretory activation in the breast that is associated with adequate short and long-term breast milk volumes in this vulnerable population.

Primary Objective: Establish feasibility, acceptance, and time cost of parent-led parent milk Na testing in the first 14 days postpartum

Secondary Objective: Further investigate relationships between pumping behaviours, lactation risk factors, daily milk Na and lactation outcomes

Exploratory Objective: Explore how POC Na data may be used to modify pumping behaviour and milk volumes


Eligibility Criteria:
Inclusion Criteria:

1. Consent provided
2. Have delivered a preterm singleton or twin infant at \<35 weeks gestation admitted to a study NICU at birth or transferred into a study NICU from another NICU within the first 72 hours postpartum
3. Day 5 or less postpartum (Day 1 = day of delivery) upon enrollment (ideally day 3 or less)
4. Plans to lactate at least 2 weeks and initiate lactation with a breast pump
5. Expected infant NICU stay of 7+ (ideally 14+) days in enrollment NICU(s)

Exclusion Criteria:

1. Potential study participant's infant is critically ill and not expected to survive or has lethal diagnosis with plans by medical team/family to redirect care
2. Has delivered triplets or higher order multiples (potential confounder for lactation challenges; of note, triplets or higher are rare, on the order of a few parents annually)
3. Lactation contraindication(s) (i.e., active chemotherapy) or declines lactation initiation
4. History of breast surgery that may affect ability to lactate (i.e., breast reduction; breast augmentation that utilized nipple incisions)
5. Using or planning to use hormonal birth control in the first 14 days post-partum as may affect secretory activation/lactation
6. Unable/unwilling to be present in study NICU during any of first 5 days postpartum
7. Presumption by the medical team that infant will be in study NICU for \<5 days
Venue Ultrasound Evaluation - Israel

The study purpose is to collect images and user feedback from the Next Generation Venue Ultrasound system, components, and accessories under clinical conditions, as required for device development and optimization.

Adult patients (aged \>18 years) will be enrolled that present for emergency or immediate medical care, in facilities such as the intensive care unit (ICU), US unit, and/or other departments. Subjects may or may not have a clinical indication for ultrasound scanning as part of their regular medical care and will be required to meet the inclusion criteria and none of the exclusion criteria. If a subject has a clinical indication for ultrasound exam, the routine exam will be performed with the standard equipment, and an additional exam will be performed using the investigational ultrasound device.

Eligibility Criteria:
Inclusion Criteria:

1. Adults (aged 18 years of age or older) at the time of consent;
2. Eligible to undergo ultrasound scanning per the site standard of care (with or without a clinical indication for scanning);
3. Able and willing to provide written informed consent for participation

Exclusion Criteria:

1. Are pregnant subjects
2. Require procedures that cannot be readily completed using available investigational devices;
3. Require or are anticipated to require medical care where study participation could reasonably be expected to adversely impact patient care.
SIIT Based on UST CDST in Patients With CD

ustekinumab (UST) can effectively induce and maintain clinical remission and mucosal healing of Crohn's disease (CD), but some patients still have poor response. Dose optimization is an effective way to improve the response rate of UST, and re-intravenous induction is a common way of optimization. For patients with secondary loss of response, about half of the patients can re-respond after dose optimization. We plan to use CDST-UST to stratify the response level of patients before treatment, select patients with poor response, and initially give multiple intravenous therapy as an intensive induction therapy strategy, so as to improve the response rate of these patients and achieve individualized treatment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with CD;
* Active period; Age 18-75 years old;
* UST-CDST scores were used to treat patients with moderate and low responsive activity

Exclusion Criteria:

* Subjects had undergone extensive colectomy, subtotal colectomy, or total colectomy; The subject currently has ileostomy and colostomy; Patients with significant liver, kidney, endocrine, respiratory, neurological or cardiovascular diseases; Patients with fibrous stenosis and prestenosis dilatation; Contraindications of UST as documented in other specifications.
Central Serous Chorioretinopathy: Etiology, Course and Prognosis

Pathogenesis of central serous chorioretinopathy is not entirely understood yet, therefore further investigations are needed. During this study patients with an acute episode of central serous chorioretinopathy are observed with established ophthalmologic methods (multimodal imagine) every 6 weeks until subretinal fluid is reabsorbed to gain further insides in etiology, course and prognosis of this disease.

Patients with central serous chorioretinopathy are recruited from the Department of Ophthalmology at the Medical University of Vienna. All patients undergo ETDRS visual acuity measurement, Pelli-Robson contrast examination, Amsler-Grid testing, questionnaire testing, ophthalmologic examination, SD-OCT and polarization-sensitive OCT, fundus autofluorescence, fluorescein angiography, indocyanine-green angiography, fundus photo and microperimetry. Patients are re-examined after an interval of 6 weeks until subretinal fluid is entirely reabsorbed to gain further insides in etiology, course and prognosis of this disease.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form
* Age over 18 years
* acute episode of Central Serous Chorioretinopathy
* Symptoms for less than two weeks
* no treatment on study eye

Exclusion Criteria:

* bad compliance
* protected patient group (pregnant women)