cyrilzakka/clinical-trials huggingface dataset:
Clinical Validation of HostDx Sepsis™ on NanoString; a Prospective Observational Validation Trial

This study will analyze HostDx Sepsis results from whole blood samples collected from patients with suspected sepsis or at risk for sepsis in the surgical ICU


Eligibility Criteria:
Inclusion Criteria:

Arm A

1. Age \> 18 years
2. Suspected sepsis at the time of admission to the ICU
3. Direct admission from the ED to the ICU with suspected/proven sepsis.
4. Post-operative ICU admission after sepsis source control procedure
5. Inpatients admitted to the ICU from the ward with suspected sepsis onset.
6. Able to provide subject/proxy informed consent within 96h

Arm B

1. Age \> 18 years
2. No suspicion of sepsis at the time of admission to the ICU but at high risk for subsequent sepsis onset
3. Non-trauma admission from the ED to the ICU
4. Post-operative ICU admission
5. Severe trauma admission from the ED (injury severity score \>15, hemorrhagic shock, severe traumatic brain injury, and or severe chest trauma)
6. Inpatients admitted to the ICU from the ward for decompensation not initially suspected to be secondary to sepsis.
7. Able to provide subject/proxy informed consent within 96h

Exclusion Criteria:

1. Pre- or post-transplant patients
2. Patients admitted solely for airway monitoring, or vascular/flap check monitoring
3. Previous diagnosis of sepsis on index hospitalization.
4. Unable to provide informed consent within 96h
5. Previously enrolled in the present study.
Brain-derived Neurotrophic Factor Participates in Visceral Hyperalgesia in Irritable Bowel Syndrome (IBS) Patients

Brain-derived neurotrophic factor (BDNF), originally known to be a member of the nerve growth factor family, has aroused attention as a modulator in visceral hyperalgesia recently. Visceral hypersensitivity is recognized as a clinical hallmark in IBS patients. So in this study, the investigators will focus on the role of BDNF in colonic hyperalgesia in IBS patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with irritable bowel syndrome.

Exclusion Criteria:

* Patients have similar clinical symptoms as IBS, yet there is morphologic changes in the intestine.
Transfusion of Red Blood Cells, Tranexamic Acid and Fibrinogen Concentrate for Severe Trauma Hemorrhage

Study Design: Single-center, not-randomized, open-label, two-arms controlled pilot clinical trial.

Health Condition: Patients with severe trauma with a need for transfusion and categorized as priority 0 or 1 according to the Catalan Health Service (CatSalut) Polytrauma Code (PPT)

Major hemorrhage in the setting of severe trauma patient is associated with significant morbidity and mortality. Hemorrhage is compounded by trauma induced coagulopathy of which hypo/dysfibrinogenemia and hypoperfusion play a significant role. There is a good evidence to suggest that hypofibrinogenemia in trauma is associated with worse outcomes and it is postulated that early replacement of fibrinogen and red blood cells packages may reduce hemorrhage and improve outcomes even in the pre-hospital phase of care. In this pilot study, the investigators will try to prove the feasibility and efficacy of managing the severe traumatic patient with red blood cells transfusion, tranexamic acid (TXA) and fibrinogen concentrate compared to standard treatment based on crystalloid fluid and TXA in the pre-hospital phase of care.

Early administration at pre-hospital phase of care of RBC, FC and TXA is feasible , secure and can help controlling trauma induced coagulopathy. Better outcomes in terms of mortality, less transfusion requirements and less crystalloid administration is expected

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years AND
* Patients with severe trauma categorized as priority 0 or 1 according to the Catalan Health Service (CatSalut). Polytrauma Code (PPT) AND
* Evidence of bleeding or a high bleeding suspicion according to physician judgment OR o Predicted to need transfusion according to TICS (Yale Global Tics Severity Scale) score ≥10.

Exclusion Criteria:

* Moribund patient with devastating injuries and expected to die within 1-hour OR
* Known objection to blood components transfusion OR
* Known acquired or congenital coagulopathies not related to the actual trauma OR
* Known anticoagulant treatment (vitamin K antagonist, dabigatran, rivaroxaban, apixaban) OR
* Known Pregnancy OR
* Severe isolated traumatic brain injury OR
* Hemorrhage not related to the actual trauma.
The Effect of Breastfeeding Education Given by Pecha Kucha Method

To evaluate the effect of breastfeeding education given with Pecha Kucha method in the prenatal period on breastfeeding self-efficacy, infant feeding attitude and breastfeeding satisfaction in the postpartum period.

Breastfeeding is the most important factor in infant nutrition. Breast milk is a nutritional source that contains the necessary nutrients for the healthy growth of infants after birth and has many benefits in terms of growth and development. However, although the rate of breastfeeding has increased today compared to the past, it is still not at the desired level. In order to increase breastfeeding rates, breastfeeding trainings should be given starting from the prenatal period. In this study, breastfeeding training will be given to pregnant women with pecha kucha method in the prenatal period and the effect of breastfeeding training on postpartum breastfeeding self-efficacy, infant feeding attitude and breastfeeding satisfaction will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Volunteered to participate in the research,
* To be able to speak and understand Turkish,
* Over 18 years of age,
* At least primary school graduate,
* Gestational week 38 weeks and above
* No chronic illness,
* Pregnant women without communication barriers will be included in the study.

Exclusion Criteria:

* Have a medical indication that prevents breastfeeding,
* Multiple pregnancies,
* A person with a mental illness,
* Not wanting to continue the research process,
* The one who still hasn't given birth 2 weeks after the training,
* Not having their baby with them after childbirth,
* Pregnant women who cannot be reached during the follow-up period will be excluded from the study
National Wilm's Tumor Study Late Effects

The Late Effects Study is being conducted in order to answer scientific questions and to serve as a resource for Wilms tumor patients and their families. Patients must have been enrolled on the NWTS-5 protocol in order to be eligible for this study.

The Late Effects Study is being conducted in order to answer scientific questions and to serve as a resource for Wilms tumor patients and their families. Although most people in this study enjoy good health, some may be at risk for certain health conditions. We are collecting information from as many participants as possible in order to determine if they or their offspring are at risk for adverse medical conditions. If there is more than one case of Wilms tumor in a given family, we plan to work with geneticists to try to estimate heritability and recurrence risks.

Eligibility Criteria:
Inclusion Criteria:

Previously enrolled in NWTS 5.
Hierarchical Diagnosis for Adult Diffuse Glioma Based on Deep Learning

This is a restrospective study to establish a deep learning model based on multi-parametric magnetic resonance imaging scans to predict Grade, histopathologic type and genotype of adult diffuse Glioma.

Glioma is a common kind of tumor in central nervous system. The pre-operative prediction of grade, histopathologic type and genotype is important for treatment and management of Adult diffuse Glioma patients. Right now, most of the diagnostic prediction models on glioma are based on 2016 WHO central nervous system tumor guideline. The goal of this study is to establish a new deep learning model to predict Grade, histopathologic type and genotype of adult diffuse Glioma. We will recruit 500 patients with pathologically confirmed diagnosis of Glioblastoma, Astrocytoma and Oligodendroglioma who received neurologic surgery in our center. Each subject underwent pre-operative multi-parametric magnetic resonance imaging scans including T1WI, T2WI, T1CE, FLAIR and DWI. Pathologic diagnosis of each patient are available in pathology department. A deep learning based hierarchical diagnosis

Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing surgery in Nanjing DrumTower Hospital between 2010.01 and 2022.05 with post-surgery pathological diagnosis of WHO Grade II to IV Adult Diffuse Glioma.
2. Available pre-surgery T1WI, T2WI, T1CE, FLARI and DWI MR sequences
3. No pre-surgery anti-tumor therapy

Exclusion Criteria:

1. Poor image quality
2. Failed image preprocessing
3. Unavailable pathology data
A Study to Compare a New Eye Drop Formulation With Refresh Contacts®

This study will compare the safety and efficacy of a new carboxymethylcellulose based eye drop formula to Refresh Contacts® for lubricating and rewetting contact lenses.


Eligibility Criteria:
Inclusion Criteria:

-Adapted contact wearer with daily usage of at least 6 hours a day, 5 days a week.

Exclusion Criteria:

* Wearing monovision lenses
* Have had refractive surgery within the previous 12 months
* Have infection of the eye, eyelids or eye structures.
Small Catheter Drainage With Chest Tube Versus Chest Tube Alone After Uniport Video-assisted Thoracoscopic Procedures

Small catheter drainage with chest tube after uniport Video-assisted Thoracoscopic Procedures

Traditionally an Intercostal Tube is applied intraoperative following VATS procedures to drain the remaining pneumothorax and residual effusion , some of the residual effusion can't drain by intercostal tube which lead to prolonged hospital stay hypothesis that putting an additional small catheter drainage at the most depended part of hemithoracic early removal of chest tube without add more pain or hospital stay to the patient.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing uniport video-assisted thoracoscopic surgery at Assiut University Hospital who need intercostal drainage postoperative

Exclusion Criteria:

* Patients who do not need intercostal tube post operative
Fistulotomy Versus Fistulotomy With Marsupialization

It was a study comparing two standard procedures for fistula in ano

It was a study which compared two standard surgical procedures for fistula in ano

Eligibility Criteria:
Inclusion Criteria:

* having low lying anal fistula Willing to enroll in study

Exclusion Criteria:

* unfit pts Having uncontrolled diabetes
CKD-330 Drug-Drug Interaction Study (Candesartan)

The purpose of this study is to evaluate a pharmacokinetic drug interaction and safety of Candesartan between free combination of Candesartan and Amlodipine and Candesartan monotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male volunteer is between 20 and 45 years of age(inclusive) at the pre-study(screening).
2. Volunteer who has 19kg/m² ≤ BMI(Body Mass Index) ≤ 26kg/m²
3. When volunteer in screening, Must include under the items.

   1. 100 mmHg ≤ sitting SBP \<140 mmHg
   2. 60 mmHg ≤ sitting DBP \< 90 mmHg
   3. 45 bpm ≤ Pulse \< 95 bpm
4. Those who decided to join the clinical trials by themselves and to comply with the precautions written consent.

Exclusion Criteria:

1. A previous history or present of clinically significant liver, renal, gastro-intestinal, pulmonary, musculoskeletal, endocrine, neuropsychiatric, hemato-oncological, cardiovascular disease.
2. Have a gastrointestinal disease history that can affect drug absorption(Crohn's disease, Ulcers, GERD, Gastritis, etc.) or surgery (except simple appendectomy or hernia surgery).
3. The history of clinically significant hypersensitivity reaction about Investigational drugs and foods.
4. The history of drug abuse or drug abuse showed a positive for urine drug test.
5. Taking drugs have received any other investigational drug within 90 days prior to the first dosing and metabolizing enzyme inducers or inhibitors such as barbitals within 30 days prior to the first dosing.
6. Whole blood donation within 60 days prior to the first dosing or plasma donation within 30 days prior to the first dosing.
7. Taking drugs that clinical trials expected to affect within 14days or taking food containing caffeine, grapefruit within 7days before the first dosing.
8. A heavy alcohol consumer(alcohol\>3cup/day or 3times/week within last 1month)
9. A heavy smoker(cigarette\>10cigarettes/day)
10. The subject has positive results of serum tests(Hepatitis B, C, HIV Test, Syphilis).
11. Have the Liver enzyme levels(AST, ALT) or Bilirubin, total results greater than 1.5 times the UNL.
12. Have the result of Creatinine clearance is less than 80mL/min(Cockcroft-Gault equation applicable).
13. The result of 12-lead ECG in screening test is QTc\>450msec.
14. An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason.
Colchicine to Reduce Your SympToms and Lower Levels of Inflammation, Zeroing in on Effective CPPD Disease Treatment

The goal of this clinical trial is to learn if colchicine reduces levels of proteins indicating inflammation in the blood in individuals with calcium pyrophosphate deposition (CPPD) disease. The trial will also test the effect of colchicine on joint symptoms in CPPD disease. The main questions it aims to answer are:

* Does colchicine reduce the level of interleukin 18 (IL-18) in the blood of individuals with CPPD disease?
* Does colchicine reduce pain scores in individuals with CPPD disease?

Researchers will compare colchicine once daily to a placebo (a look-alike pill that contains no drug) to see if colchicine works to treat CPPD disease.

Participants will:

* Take colchicine or a placebo every day for 6 months
* Visit the clinic 3 times in 6 months for joint examinations, surveys, and blood tests. Each visit will last 2-3 hours.
* Speak on the telephone with researchers for about 4 times over 6 months. Each phone call will last about 5 minutes.


Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent
* Fulfill ACR/EULAR 2023 CPPD classification criteria
* Acute or chronic joint inflammation in the past 3 months, not attributable to another condition
* Pain visual analog scale (pain VAS) \>=30 at screening

Exclusion Criteria:

* age \<40 years
* chronic diarrhea
* gout, rheumatoid arthritis, or psoriatic arthritis
* cirrhosis
* ongoing use of colchicine and unwilling to undergo a 30-day wash-out period (note: patients using colchicine at screening can enroll if they agree to a 30-day wash-out before randomization)
* pregnant or breast-feeding
* use of methotrexate, hydroxychloroquine, or anakinra in the past month
* use of oral glucocorticoid in the past week
* use of strong CYP3A4 inhibitors per FDA package insert for colchicine
* use of P-glycoprotein inhibitors per FDA package insert for colchicine
* known allergy to colchicine

Screening labs with any of the following:

* hemoglobin \< 11.5 g/dL
* WBC \<3 x 10\^9/L
* platelets \<110 x10\^9/L
* creatinine clearance (CrCl) \<30 mL/min
* ALT or AST \>3x upper limit of normal (ULN)
Vital Signs Validation Study of the μ-Cor System (ViVUS Validation)

This study has the following objective:

• To validate the capability of the μ-Cor System to monitor ECG, Heart Rate (HR), Respiration Rate (RR), Posture and Activity in healthy human subjects.

The μ-Cor validation will be demonstrated at two body locations:

1. Side location (below left armpit) for study arm 1, and
2. Front location (upper left chest) for study arm 2 An FDA-cleared comparator device will be used to support the validation of the study device.

This study has the following objective:

• To validate the capability of the μ-Cor System to monitor ECG, Heart Rate (HR), Respiration Rate (RR), Posture and Activity in healthy human subjects.

The μ-Cor validation will be demonstrated at two body locations:

1. Side location (below left armpit) for study arm 1, and
2. Front location (upper left chest) for study arm 2 An FDA-cleared comparator device will be used to support the validation of the study device.

Eligibility Criteria:
Inclusion Criteria:

* Subject is at least 21 years of age or older.
* Subject is willing and able to sign the Informed Consent Form.
* Subject is healthy, able and willing to complete all the preparation steps and study procedures.

Exclusion Criteria

* Female subject with a known pregnancy or unsure about pregnancy status.
* Subjects with allergies and/or skin sensitivities to electrode hydrogel and/or acrylic based adhesive.
* Subjects with skin breakdown in areas where device placement is required.
* Subjects with chronic lung disease or asthma.
* Subjects with a history of cardiovascular diseases.
* Subjects who are diabetic.
* Subjects living with kidney failure or dialysis.
* Subjects with a history of liver failure.
* Subjects with any known malignancy (i.e. cancer patients).
* Subjects with implanted devices in the thoracic region
COVID-19 Vaccine Biomarker Study in Multiple Sclerosis

SARS CoV-2 is the virus responsible for the pandemic COVID-19, which has resulted in nearly five million deaths worldwide since its spread in the beginning of 2020. In the United States, there are now two emergency use authorized vaccines that make use of messenger ribonucleic acid (mRNA) based technology that are highly effective for preventing COVID. However, because multiple sclerosis is an autoimmune condition, many individuals with multiple sclerosis take medicines that affect the immune system. The investigators are not sure whether individuals on certain MS medications, including medications that lower a type of immune cell called B lymphocytes, will form as robust of a response to the vaccines. In this study, the investigators will be gathering more information about effectiveness of these vaccines and bloodwork that looks at antibodies and other markers of vaccine response and by asking patients about COVID-19 infections.

SARS CoV-2 is the virus responsible for the pandemic COVID-19, which has resulted in nearly five million deaths worldwide since its spread in the beginning of 2020. In the United States, there are currently two emergency use authorized mRNA based vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Multiple sclerosis (MS) is a neurological autoimmune disease involving the central nervous system and requiring long-term immunomodulating therapy to control relapse and progression. While there are many approved medications for the treatment of MS, agents that work through B-lymphocyte depletion or sequestration are among the commonly used treatments. There is concern that individuals with low levels of circulating B-cells might not mount an effective humoral or cellular immune response after vaccination. Moreover, it remains to be understood whether, at certain timepoints within the treatment cycle, there is a greater immune response mounted while on B-cell depleting medication. Availability of such knowledge could guide counseling and management of patients on immunomodulatory therapy. Aim: To ascertain efficacy of mRNA based SARS CoV-2 vaccines in individuals with MS across the immunotherapy spectrum, via biomarker data of humoral and cellular immunity and via clinical data. Blood will be drawn for markers of immunity and sequence-based analysis before and after vaccination at predetermined time points. The investigators will document the type of immunotherapy being used at the time of vaccination. Clinical data on diagnosis of SARS-CoV2 infection will be collected at each of the prespecified timepoints.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of any form of multiple sclerosis based on 2017 McDonald Criteria
* Ages 18 to 70
* No history of prior vaccination against SARS-CoV-2 at the start of the study

Exclusion Criteria:

* Unable to obtain blood draws at predetermined time points
* Pregnant at time of enrollment or planning pregnancy during upcoming 6 month period after vaccination
African Youth in Mind (Y-MIND) - Pilot Feasibility Trial of a Brief Psychological Intervention for Young People with Depression in Zimbabwe

The overarching aim of this single-arm pilot study is to assess the feasibility of implementing a psychological intervention (Y-MIND), delivered by lay counsellors, for the treatment of depression among young people aged 15-24 in in Harare Province, Zimbabwe. The study aims to assess the feasibility, acceptability and fidelity of delivering the six-session Y-MIND intervention, and collect preliminary clinical outcomes for depression at 5-month follow up.

The overarching aim of this single-arm pilot study is to assess the feasibility of implementing a psychological intervention (Y-MIND) for the treatment of depression among young people aged 15-24 in in Harare Province, Zimbabwe. The six session problem solving therapy intervention will be delivered by trained and supervised lay counsellors. 50 young people will be recruited aged 15-24 through primary care clinics to receive the Y Mind intervention. The study aims to assess the feasibility, acceptability and fidelity of delivering the six-session Y-MIND intervention, and collect preliminary clinical outcomes for depression at 5-month follow up.

Eligibility Criteria:
Inclusion Criteria:

* Young people aged 15-24 years
* Scoring 11 or more on the locally validated Patient Health Questionnaire-9 (PHQ-9) for those aged 18+ and 10 or more on the Patient Health Questionnaire Adolescent (PHQ-A) for those \< 18 years.
* Willing and able to be followed up for 5 months.
* Willing and able to provide informed consent if aged 18+, or, if aged below 18, willing and able to give informed assent and to approach a caregiver for informed consent procedures

Exclusion Criteria:

* Currently receiving any psychological treatment for any common mental disorder through formal health care services
* Active major mental disorder, advanced physical illness which would interfere with their ability to take part in the study or are actively suicidal (assessed through screening using the P4 screener).
* Those with visual and/or hearing impairment; defined as being unable to see and read the intervention manual or hear the interventionist sitting approximately 1 metre away. This will be assessed at informed consent procedures.