cyrilzakka/clinical-trials huggingface dataset:
A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC)

The main purpose of this study is to compare the clinical benefit, as measured by Progression-Free Survival (PFS), Objective Response Rate (ORR), and Overall Survival (OS), achieved by nivolumab in combination with ipilimumab or by nivolumab monotherapy in participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) metastatic colorectal cancer (mCRC). This study will also compare nivolumab plus ipilimumab combination vs chemotherapy for treatment of MSI-H/dMMR mCRC participants.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed recurrent or metastatic colorectal cancer (CRC) irrespective of prior treatment history with chemotherapy and/or targeted agents not amenable to surgery (Applicable only during Part 1 enrollment of the study)
* Histologically confirmed recurrent or metastatic CRC with no prior treatment history with chemotherapy and/or targeted agents for metastatic disease and not amenable to surgery (Applicable during Part 2 enrollment of the study)
* Known tumor microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) status per local standard of practice
* Eastern cooperative oncology group (ECOG) performance status lower than or equal to 1

Exclusion Criteria:

* An active, known or suspected autoimmune disease
* History of interstitial lung disease or pneumonitis
* Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)

Other protocol-defined inclusion/exclusion criteria apply
Clinical Study to Assess Efficacy and Safety of a New Compression System in the Management of Venous Leg Ulcers

The primary objective of this study is to demonstrate the non-inferiority of the 2-layer compression system Kit Biflex® with regard of the 4-layer compression system PROFORE® in the treatment of venous leg ulcers in terms of complete healing at 16 weeks.

This trial is a multicentre, randomized, comparative, open label clinical study conducted in vascular medicine centres in France, with 2 parallel groups of 100 patients each. The study will be conducted in patients suffering from venous leg ulcer (stage C6 of the CEAP classification for chronic venous disorders).

The patients will be randomised at the inclusion: they will receive with either Kit Biflex® or the reference device (Profore®) for maximum 16 weeks (or until full healing).

Investigator assessments are planned every 4 weeks +/- 3 days, for 16 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Inpatients or outpatients.
* Agreeing to wear a multilayer compression system throughout the study period.
* Presenting with an active venous leg ulcer: Duration between 1-24 months (whether a new ulcer or a recurrent ulcer); Surface area between 2-50 cm2; Venous, superficial or post-thrombotic ulcer confirmed by Doppler ultrasonography (dated within six months).
* With ankle circumference between 18-25 cm to allow the laying of the compression system.
* Able to follow the study instructions.
* Having read the information sheet and dated and signed the informed consent form.
* Covered by a health insurance system.

Exclusion Criteria:

* Scheduled surgery for the ulcer during the 16 weeks following inclusion.
* Clinical superinfected ulcer not controlled oral antibiotics.
* Malignant ulcer.
* Ulcer surface totally covered with dry fibrinous tissue or covered with black necrotic plaque on over 10% of its surface.
* Deep Vein Thrombosis within the last 3 months.
* Corticosteroids treatment (equivalent to more than 10 mg per day of prednisolone) ongoing or planned during the study.
* Radiotherapy, chemotherapy or immunosuppressive therapy ongoing or planned during the study.
* Erysipelas and lymphangitis.
* Lower extremity arterial disease or microangiopathy (Ankle Brachial Pressure Index \<0.8 or\> 1.3).
* Uncontrolled non-insulin dependent diabetes (HbA1c\> 8%).
* Insulin-dependent diabetes.
* Confined to bed.
* With any uncontrolled severe and progressive disease.
* With a known or suspected hypersensitivity to any of the components of the study devices.
* Who had participated in a previous clinical study within the past 3 months.
* Pregnant women.
Chest Ultrasound Versus Chest X-ray with Ct As Gold Standard At Trauma Patients

The goal of this observational study is to learn about the predictive value of the chest ultrasound in detection of pneumothorax at chest trauma patients.

The main question it aims to answer is:

How does the performance of the chest ultrasound compare to chest X-ray in predicting pneumothorax in chest trauma patients in Egypt? Participants are patients with different ages Isolated blunt chest trauma patients admitted to the emergency department during the study period.

Chest trauma is a leading cause of morbidity and mortality, with timely and accurate diagnosis essential for effective treatment. While chest X-ray (CXR) has traditionally been the first-line imaging modality in emergency settings due to its availability and ease of use, it has limitations, particularly in detecting subtle or occult injuries like pneumothorax, haemothorax, rib fractures, and pulmonary contusions, especially in trauma patients positioned supine. Overuse of CXR can also lead to increased costs, radiation exposure, and emergency department overcrowding.

Ultrasound has emerged as an alternative, with multiple studies showing that chest ultrasonography (CUS) is highly sensitive and specific for detecting traumatic intrathoracic injuries, including pneumothorax. This systematic review and meta-analysis aimed to assess the diagnostic accuracy of CUS compared to CXR. While CT scans remain the gold standard for diagnosing thoracic trauma due to their superior accuracy, they expose patients to significant radiation and should be used judiciously. Although CXR is a fast and accessible option in emergencies, it may miss critical injuries, highlighting the importance of balancing diagnostic accuracy with patient safety and resource management in trauma care.

The primary aim of this study is to evaluate and compare the diagnostic accuracy of chest ultrasonography (sonar) versus chest X-ray (CXR) in the detection of thoracic injuries in patients presenting with chest trauma, using computed tomography (CT) as the reference standard.

Eligibility Criteria:
Inclusion Criteria:

* patients with different ages.
* both genders.
* Patients presenting with isolated blunt chest trauma.
* Patients who are hemodynamically stable and can undergo imaging studies (Ultrasonography, CXR, and CT).
* Patients who provide informed consent (or proxy consent if the patient incapacitated).

Exclusion Criteria:

* Hemodynamically unstable patients requiring immediate surgical intervention.
* Patients with contraindications to CT imaging (e.g., severe renal impairment without access to alternative contrast agents).
* Pregnant patients (due to radiation exposure from CT).
* Patients with previous thoracic surgery or pre-existing significant thoracic abnormalities that could interfere with imaging interpretation.
An Attempt to Reduce Community-Acquired Methicillin-Resistant Staphylococcus Aureus (MRSA) Infection in Soldiers

The main purpose of this study is to determine if applying mupirocin into soldiers noses who are colonized with methicillin-resistant Staphylococcus aureus (MRSA) will reduce infections in them and their cohort of fellow soldiers.

Community-acquired MRSA infections are increasingly common in the community and in particular among certain groups of which soldiers are one. Many researchers and clinicians have postulated that one method to prevent infections is to selectively eradicate CA-MRSA in those who are colonized with the pathogen. The two main purposes of the study are: to determine if selective CA-MRSA eradication in subjects reduces infections in the CA-MRSA colonized individual; and to determine if selective CA-MRSA eradication in subjects reduces infections in the study cohort. Other information concerning CA-MRSA includes: prevalence, risk factors, and virulence data. The population will be soldiers enrolled in the combat medic training class at Ft. Sam Houston. We will enroll approximately 3000 soldiers over a two year period. After informed written consent, we will culture their anterior nares nares and administer questionnaires at the beginning and at the end of the study, following them prospectively for infections. The follow-up period will be 16 weeks. For those with CA-MRSA in their nares, they will be randomized (by cohort) to receive either 5 days of mupirocin or placebo.

Eligibility Criteria:
Inclusion Criteria:Soldiers enrolled into the combat medic course at Ft. Sam Houston, TX.

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Exclusion Criteria: Allergy to mupirocin.

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RDEA3170 and Febuxostat Combination Study in Gout Subjects

This is a Phase 2a, randomized, open-label, multicenter study to assess the pharmacodynamic (PD) effects and safety of RDEA3170 administered in combination with febuxostat compared to febuxostat administered alone in adult subjects with gout.


Eligibility Criteria:
Inclusion Criteria:

* Able to understand the study procedures and the risks involved and is willing to provide written informed consent before the first study-related activity.
* Meets one or more criteria for the diagnosis of gout as per the American Rheumatism Association Criteria for the Classification of Acute Arthritis of Primary Gout.
* Body weight ≥ 50 kg (110 lbs) and a body mass index ≥ 18 and ≤ 45 kg/m2.
* Screening serum urate level ≥ 8 mg/dL.
* Free of any clinically significant disease or medical condition, per the Investigator's judgment.

Exclusion Criteria:

* Unable to take colchicine for gout flare prophylaxis.
* History or suspicion of kidney stones.
* Any gastrointestinal disorder that affects motility and/or absorption.
* Unstable angina, New York Heart Association class III or IV heart failure, ischemic heart disease, stroke, or deep venous thrombosis within 12 months prior to Day 1; or subject is currently receiving anticoagulants.
* Screening laboratory parameters that are outside the normal limits and are considered clinically significant by the Investigator.
* Estimated creatinine clearance \< 60 mL/min calculated by the Cockcroft-Gault formula using ideal body weight during the Screening period.
* Taking losartan, fenofibrate, guaifenesin, or sodium-glucose linked transporter-2 inhibitors; chronic and stable doses are permitted if doses are stable for at least 14 days prior to study medication dosing.
* Unable or unwilling to comply with the study requirements or has a situation or condition that, in the opinion of the Investigator, may interfere with participation in the study.
Atrasentan and Zometa for Men With Prostate Cancer Metastatic to Bone

The main purpose of this study is to look at the effects (good or bad) that Atrasentan given alone and Atrasentan given with Zometa has on levels of bone formation and bone destruction in men with prostate cancer that has spread to the bones.

* Patients will be randomized to either receive Atrasentan alone or Atrasentan plus Zometa.
* Patients receiving Atrasentan alone will receive this drug in pill form once daily for 12 weeks. Patients will have a physical exam, blood work, and a urine sample performed once every other week during the first four weeks of medication administration. After those two initial visits, they will return to the clinic once every 4 weeks to have the same tests repeated. A bone scan and abdominal-pelvic CT Scan will be done every 12 weeks.
* After the patient has been taking Atrasentan for 12 weeks, if the disease has not progressed, they will begin combination treatment of Atrasentan and Zometa.
* Patients receiving Atrasentan plus Zometa, receive Zometa intravenously and then immediately start Atrasentan orally once daily as long as they remain on the study. Patients will return to the clinic twice over the first 4 weeks (once every other week) to have a physical exam, blood work and urine test performed. After these two initial visits, they will return to the clinic once every 4 weeks to have the tests repeated and to receive another treatment of zometa. A bone scan and an abdominal-pelvic CT Scan will be done once every 12 weeks.
* Patients participation in this study will last as long as the disease does not progress and they are not experiencing any serious side effects.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the prostate
* History of bilateral orchiectomy or current treatment with a GnRH agonist or antagonist
* Radiographically documented bone metastases
* Disease progression according to criteria from the PSA Working Group

Exclusion Criteria:

* Prior treatment with Atrasentan or Zometa within one year
* Serum creatinine \> 2.0mg/dL
* Documented cardiovascular disability status of New York Heart Association Class 2
* Treatment with chemotherapy, radiation, steroids, estrogens, or PC-SPES within 6 weeks
* Treatment with bisphosphonates or radiopharmaceuticals within 12 weeks
* History of Paget's disease, hyperthyroidism, hyperparathyroidism, Cushing's syndrome, hyperprolactinemia or other disorder associated with metabolic bone disease.
Clinical Trial to Assess the Influence of Gestational Stage and Maternal Age on Arterial Stiffness of the Mother

This is a single-centre, open, parallel-group study with three age groups; no study medication or intervention will be provided. This is a longitudinal follow-up of physiological parameters.

The subjects will be investigated as outpatients. For each subject, 4 individual dates with a duration of approximately 30 minutes each are scheduled - at the end of the first trimenon, at the end of the second trimenon, 4 weeks prior to the calculated date of birth, and 6 weeks after the effective date of birth.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women without major concomitant disease
* Willing and able to provide informed consent
* Age (three age groups):

  * 20 to 22 years
  * 30 to 32 years
  * 40 to 42 years

Exclusion Criteria:

* Non pregnant women
* Men
* No informed consent
* Age not included in inclusion criteria
* Major concomitant disease
Thalidomide and Dacarbazine for Metastatic Melanoma

The purpose of this clinical trial is to assess the activity of thalidomide in combination with dacarbazine (DTIC) in patients with metastatic melanoma. Safety and toxicity of the two drugs will also be assessed. Dacarbazine is the standard medical treatment for metastatic melanoma. It has been shown to produce tumor shrinkage in approximately 20% of patients with advanced melanoma. This shrinkage is usually incomplete and lasts a short time. Thalidomide is a drug that inhibits tumor blood vessel growth. It can be given orally. It is hoped that this combination can be given to patients with metastatic melanoma without causing too much toxicity while increasing the response rate.


Eligibility Criteria:
Inclusion Criteria:

* Patients with metastatic melanoma.
* Lesions must be measurable.
* Patient must have the following minimum labs: ANC\> 1500/mm3, Hemoglobin \> 8 mg/dl; platelets \> 100,000 mm3; and liver function tests \< 5x normal; and creatinine \< 1.5 mg/dl.
* ECOG performance status \> 2.
* No prior therapy with DTIC or thalidomide
* No other history of malignancy other than curatively resected basal cell carcinoma of the skin or carcinoma in situ of the cervix.
* Patients must not be pregnant or lactating.
* Sexually active men and women of childbearing age must use adequate contraception. All patients must understand the potential for severe birth defects with thalidomide and must be able to follow instructions to avoid conception while taking thalidomide
Can Wearable Technology Products Change Our Patient Management in Laparoscopic Colorectal Cancer Surgery

The clinical progress of the patients whose mobilization the investigators follow up with wearable technology products will be observed in the early postoperative period until discharge. In this way, the investigators primarily aim to examine whether the bowel movements of our more mobilized patients return earlier.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent laparoscopic abdominal surgery
* Colorectal cancer patients
* Curative surgeries
* Stage 0,1,2,3 patients

Exclusion Criteria:

* Patients who cannot walk
* Patients converted to open procedure
* Patients with ostomy
* Patients for whom laparoscopy is contraindicated
* Palliative surgeries
* Patients with distant organ metastases
DrIFT 2 Study: Displacement in Feeding Tubes

The proposed study will use an electromagnetic placement device (EMPD), Cortrak\* 2 Enteral Access System (EAS™), Avanos Medical, to verify feeding tube (FT) position on a daily basis to assess for migration. The EMPD provides real-time FT placement data. A sensor located on the distal end of the FT guidewire communicates with a receiver unit which sits on the patient's abdomen. Three visual insertion tracings with varying views (anterior, lateral, and depth/cross-section) can be saved and printed for comparison.

Two previous studies have been completed with similar methodology. A pilot study of 50 subjects was performed using the original Cortrak\* (2 insertion views) and found only minimal forward migration. No reverse migration was reported in one study.

A pilot study of 20 patients with 62 feeding tube assessment identified 8 migration events (5 retrograde and 3 forward), these events only occurred within the small bowel. Based on this data, a recommendation could be made that there is no need to check feeding tube placement routinely every four hours. However, due to the small sample size, additional research is needed to confirm this finding. It is also unknown if there may be more migration with positioning changes, for example, up in the chair or prone position.

The proposed study will use an electromagnetic placement device (EMPD), Cortrak\* 2 Enteral Access System (EAS™), Avanos Medical, to verify FT position on a daily basis to assess for migration. The proposed study will take place in critical care units at Parkview Health. The primary aim will be to determine if replication of the pilot study results in similar findings. Investigators will also explore other factors that may be associated with FT migration, such as patient mobility (ambulation or sitting at bedside or prone position) and transporting out of the critical care unit for diagnostic procedures. Researchers anticipate that results from this study will provide a better understanding of FT position and migration over time and ultimately influence recommendations for practice for frequency of routine FT verification. Standard of care for assessing feeding tube placement location every 4 hours will remain in place. The study will add an additional assessment for feeding tube location daily. This study will expand on the findings from the initial pilot study with a larger sample size.

Eligibility Criteria:
Inclusion Criteria:

* Adult critical care patients with small bore feeding tube inserted within last 24-48 hours
* Initial Cortrak insertion tracings: all 3 views available
* Cortrak guidewire available

Exclusion Criteria:

* Unable to speak or understand English language
* Pregnancy
* Prisoners
* FT anticipated to be removed within 24 hours
* Contraindications to placing a mark on the abdomen for top foot of receiver unit (large dressings, open abdomen, halo vest, etc.)
* Original guidewire unavailable
Impact of Immunosuppressive Regimens on Polyomavirus-related Transplant Nephropathy

The aim of this study is to characterize and evaluate risk factors of polyomavirus nephropathy (PVN) including the impact of three immunosuppressive regimens.

Polyomavirus nephropathy (PVN) is an emerging cause of renal transplant loss. Until now the risk factors of PVN are poorly understood. Tacrolimus (Tacr) and mycophenolate mofetil (MMF) are thought to be associated with a higher risk of developing PVN. However, the way in which Tacr or MMF might enhance the susceptibility for PVN remains largely unknown. In this prospective study we will analyze whether differences in immune-reactivity patterns (Th1, Th2, B cell and monocyte responses, sCD30, immunoregulatory antibodies) of renal transplant patients induced by different immunosuppressive regimens (cyclosporine A \[CsA\]/MMF, Tacr/MMF, Tacr/MMF with conversion to Tacr/Everolimus \[ERL\]) or by cytokine promoter gene polymorphisms may account for the different risks of developing PVN.

Comparison(s): renal transplant recipients stratified according to their relative immunological risk (group 1: low risk (primary recipients without pre-immunization \[PRA \< 5%\]); group 2: moderate risk (group 2a: primary recipients with low pre-immunization \[PRA 6-20%\]; group 2b: re-transplanted patients); group 3: very high risk (re-transplanted patients with a history of vascular rejection or recipients of a first graft with high pre-immunization \[PRA \> 20%\]) randomized to be treated with one of three immunosuppressive regimens (CsA/MMF, Tacr/MMF, Tacr/MMF with subsequent conversion to Tacr/ERL).

Eligibility Criteria:
Inclusion Criteria:

* Cadaver kidney and living donor kidney transplant recipients
* Primary, secondary, and tertiary transplant recipients
* Pre-immunized and not pre-immunized transplant recipients
* Age \> 18 years

Exclusion Criteria:

* Contraindications against administration of one of the four study drugs
* History of severe gastrointestinal morbidity
* Age \< 18 years
* Pregnant or breast feeding women
* Rejection of effective contraceptive methods with young women
* Combined kidney and islet cell transplantation
Vortioxetine in Patients With Depression Coexisting With General Anxiety Disorder (GAD)

This study evaluates the effectiveness of vortioxetine on depressive symptoms in patients with depression coexisting with generalized anxiety disorder.

100 patients, recruited from psychiatrist outpatient clinics are planned for enrolment. Approximately 50 of these patients will receive vortioxetine as a first treatment for the current Major Depressive Episode (MDE) (first treatment patients) and 50 patients will be switched to vortioxetine due to inadequate response to the current antidepressant medication treatment (switch patients).

Eligibility Criteria:
Inclusion Criteria:

* The patient has a primary diagnosis of MDE, diagnosed according to DSM-5® confirmed using the Mini International Neuropsychiatric Interview (MINI).
* The patient has had the current MDE for \<12 months
* The patient has current comorbid Generalized Anxiety Disorder (GAD) according to DSM-5®. The diagnosis was made prior to the current MDE
* The patient has a Montgomery and Åsberg Depression Rating Scale (MADRS) total score ≥ 22 at the Baseline Visit
* The patient has a Hamilton Anxiety Rating Scale (HAM-A) score ≥ 20 at the Baseline Visit

Exclusion Criteria:

* The patient has any current psychiatric disorder or Axis I disorder (DSM-5® criteria), established as the primary diagnosis, other than MDD, as assessed using the Mini International Neuropsychiatric Interview (MINI) or another diagnostic interview.
* The patient has a history of previous major depressive episodes considered as treatment resistant, defined as inadequate response (incomplete or no therapeutic response) to two prior courses of at least 6 weeks of conventional antidepressant drugs in adequate dosages or, the patient has treatment-resistant depression in the investigator's opinion.

Other in- or exclusion criteria may apply