cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Possible Effect of Inspiratory Muscle Training on Inflammation Markers and Oxidative Stress in Childhood Asthma

As inflammation and oxidative stress increase in asthma patients, the severity of symptoms and clinical findings increase. Therefore, this study was planned to evaluate the possible effect of inspiratory muscle training (IMT) on inflammation markers and oxidative stress in childhood asthma.

The study included asthma patient; 35 routine medication, 35 drug therapy and inspiratory muscle training (IMT), and 35 healthy total 105 children aged 8-17 years. Demographic information and hemogram values were recorded. Functional capacity was evaluated with the 6-minute walking test, quality of life PedsQL, respiratory muscle strength oral pressure measuring device, respiratory function test, dyspnea severity with Modified Borg Scale. C-Reactive Protein (CRP), Periostin, Transforming Growth Factor-βeta (TGF-β), Total Antioxidant Status (TAS), Total Oxidant Status (TOS), Oxidative Stress Index (OSI) were analyzed. IMT was given with a Threshold IMT device for 7 days/6 weeks at 30% of maximal inspiratory pressure, and then a second evaluation was made.


Eligibility Criteria:
Inclusion Criteria:

* Have been diagnosed with asthma,
* Between the ages of 8-17,
* No asthma attack,
* Cooperating with the study,
* Without cerebral palsy, mental retardation or any other major neurological diagnosis,
* Agreeing to participate in the study,
* Cases whose medication has not been changed for at least three weeks.

Exclusion Criteria:

* Presence of kyphoscoliosis that may affect respiration,
* Having advanced postural alignment problem,
* Having mental problems,
* Having neuromuscular disease,
* Making changes in the medications used in the last three weeks,
* Presence of inflammatory diseases such as juvenile idiopathic arthritis.
A Study of a Topical Form of Nitroglycerin and Placebo in the Treatment and Prevention of Raynaud's Phenomenon

The purpose of this research study is to test the safety, tolerability, and effectiveness of Topical AmphiMatrix with Nitroglycerin (MQX0503) to relieve Raynaud's symptoms and increase blood flow to the fingers.

The purpose of this clinical study is to determine, in a controlled fashion, the ability of a topical formulation of Nitroglycerin, MQX-503, to improve the patient's health assessment as indicated by patient and physician assessments, decrease the frequency of Raynaud's events, decrease the duration of Raynaud's events, and decrease the symptoms (pain, tingling, numbness) in the fingers of Raynaud's patients. The study will include patients with moderate to severe primary Raynaud's Phenomenon (RP) and with moderate to severe Raynaud's Phenomenon secondary to autoimmune diseases, such as scleroderma.

Eligibility Criteria:
Inclusion Criteria:

* Outpatients ages 15 - 70.
* Patients with a diagnosis of Raynaud's phenomenon.
* Patients who agree to apply study medication to their fingers.
* Patients who are willing to stop current topical vasodilator therapies.
* Patients who agree not to start or change dosage of current oral vasodilator therapies.
* Patients who agree not to use any nitrate therapy while participating in this study.
* Negative pregnancy test in fertile women and agreement to use effective contraception throughout the study.

Exclusion Criteria:

* Patients who currently use nitrate medication or medications known to interact with nitroglycerin.
* Patients who have an allergy to nitroglycerin or common topical gel ingredients.
* Patients with a history of severe headaches.
* Patients with an unstable medical problem.
* Patients with cognitive or language difficulties that would impair their ability to complete assessment of pain instruments.
* Patients who have had a recent heart attack or other uncontrolled heart condition.
* Patients who have participated in an investigational drug study within four weeks of visit one.
* Patients who have clinically significant abnormal lab values.
* Patients who have had recent major abdominal, thoracic or vascular surgery.
* Patients with interfering skin conditions.
* Pregnant or nursing women or women unwilling to comply with contraceptive requirements.
Evaluation of the Tolerance of Three Masks Under Dermatological Control.

This is a monocentric, open and randomized study. The purpose is to evaluate the cutaneous tolerance of three medical masks (class I medical device) after 3 consecutive days of use on a population with normal or sensitive skin.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy Subject;
2. Sex: male or female ;
3. Age: more than 18 years ;
4. Phototype: I to IV on the Fitzpatrick scale;
5. For half of the population in each group : subject presenting a sensitive skin on the face confirmed by an interrogatory with the investigator (see Appendix 19.1).
6. Subjects who did not use any new cosmetic product on the face in the past 30 days and who agree not to change them during the study period.
7. Subject having given freely and expressly his/her informed consent;
8. For subjects randomized to group 3: Fit test FFP on M52014-WH

Exclusion Criteria:

In terms of population

1. Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship;
2. Subject in a social or sanitary establishment;
3. Subject suspected to be non-compliant according to the investigator's judgment;
4. Subject enrolled in another clinical trial or which exclusion period is not over.
5. Subject majors under curatorship, safeguard of justice, activated future protection mandate or family authorization In terms of associated pathology
6. Subject with a condition or receiving a medication which, in the investigator's judgment, put the subject at undue risk;
7. Subject suffering from a severe or progressive disease.
8. Subject's with too many hairs, bears,(to put above) skin lesions, skin disease or severe acne on the face that could interfere with the tolerance evaluation.
9. Subject' who is allergic to one or several component of the studied devices. Relating to previous or ongoing treatment
10. Subject undergoing a topical treatment on the test area or a systemic treatment:

    * anti-inflammatory medication and/or antihistamines during the 2 weeks prior to screening and during the study;
    * corticosteroids during the 2 weeks and prior to screening and during the study;
    * retinoids and/or immunosuppressors during the 3 months prior to screening and during the study;
11. Subject having started or changed any hormonal treatment during the three previous months.

    In terms of lifestyle
12. Intensive exposure to sunlight or UV-rays within the previous month and/or foreseen during the study;
13. Subject planning to change her/his life habits during the study;
Rapid First Contact Using Virtual Visits to Improve Time-To-Treatment for Uterine Cancer

This project aims to evaluate whether rapid first contact with the oncologist the same day or the next day after pathologic diagnosis contributes to a decreased time to treatment, decreased patient anxiety and increased patient satisfaction.

Time to treatment (time from disease diagnosis to initiation of treatment) impacts outcomes in uterine cancer. When controlled for stage, patients with longer time to treatment tend to have less favorable outcomes. Similarly, longer time to treatment has a negative impact on patients' quality of life and markers for anxiety. Our experience at this institution suggests that the time to referral (time from uterine cancer diagnosis and the patients' first encounter with the oncologist) is variable and presents the greatest opportunity for decreasing time to treatment. Among the factors that contribute to the time to referral are the time taken by the referring provider to relay the diagnosis to the patient, time taken to schedule an appointment with the specialist, and the patient's availability to keep an appointment.

Virtual visits provide an opportunity to expedite consultation with the treating oncologist by removing some of the barriers that delay face-to-face visits. Among these barriers are patients' availability for a short notice face-to-face visit based on their work or family obligations, access to transportation, and mental preparedness.

Eligibility Criteria:
Inclusion Criteria:

* Uterine cancer diagnosis on biopsy read by Cleveland Clinic Pathology Department
* Patients must be willing to participate in a virtual visit as the initial meeting with an oncologist at the Cleveland Clinic.
* Receive care at Fairview Hospital, Hillcrest Hospital or Cleveland Clinic Main Campus
* Internet connected smartphone or internet connected computer with webcam
* Participants must have email access
* English speaking
* Competent to make clinic decisions

Exclusion Criteria:

* No diagnosis of uterine cancer
A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia

The purpose of this study is to evaluate the safety, tolerability and determine the recommended dose for further clinical evaluation of ELVN-001 in patients with chronic myeloid leukemia with and without T315I mutations in patients who are relapsed, refractory or intolerant to TKIs.

This first-in-human trial with ELVN-001 is a dose escalation study with the primary purpose to identify the recommended dose(s) for expansion (RDEs) of single agent ELVN-001 in chronic phase CML with or without T315I mutations. The safety, tolerability and pharmacokinetic profile of ELVN-001 will be assessed together with an evaluation of changes in BCR-ABL1 transcript. An understanding of the safety profile, PK and preliminary evidence of anti-CML activity will be used to inform future development of ELVN-001 in adults with CML. By virtue of its predicted pharmacological profile ELVN-001 has the potential to be tolerable and achieve a deep molecular response in patients with CML with or without T315I mutations who do not tolerate or benefit from available TKIs.

Eligibility Criteria:
Inclusion Criteria:

* BCR-ABL1 positive CML in chronic phase, with or without T315I mutation.
* The patient has failed, is intolerant to, or not a candidate for, available therapies known to be active for treatment of their CML.
* ECOG performance status of 0 to 2.
* Adequate hematologic, hepatic and renal function.
* Prior bone marrow transplant allowed if ≥ 6 months prior to the first dose of ELVN-001.

Exclusion Criteria:

* Treatment with anti-cancer or anti-CML therapy within 7 days or 5 half-lives, whichever is longer.
* History of acute tyrosine kinase inhibitor (TKI)-related pancreatitis within 6 months of study entry. Active chronic pancreatitis, or pancreatic disease due to any cause.
* QTc \>470 ms.
Clinical Evaluation of the Phototoxic Potential of Xenaderm Ointment

The product is being tested to see if exposure to light causes toxic reactions on the skin.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects

Exclusion Criteria:

* Under 18 years of age
Outcomes in Ovarian Cancer and Fallopian Tube Cancer Patients Using Complementary Alternative Medicine

RATIONALE: Chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Hypnosis, massage therapy, and healing touch may improve the quality of life of patients who are undergoing chemotherapy.

PURPOSE: This randomized clinical trial is studying how well giving hypnosis, massage therapy and healing touch changes outcomes in women receiving chemotherapy for newly diagnosed epithelial ovarian, fallopian tube or peritoneal cavity cancer.

OBJECTIVES:

Primary

* Determine whether quality of life is improved in patients with epithelial ovarian, fallopian tube or primary peritoneal cavity cancer receiving hypnosis, massage therapy, and healing touch and standard chemotherapy as compared to patients receiving standard chemotherapy alone.

Secondary

* Determine changes in immunologic response markers, chemotherapy side effects, and complication rates in these patients.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.

* Arm I (standard therapy): Patients undergo standard chemotherapy for epithelial ovarian, fallopian tube or primary peritoneal cancer.
* Arm II (standard therapy with complementary alternative medicine): Patients undergo chemotherapy as in arm I. Patients also undergo massage over approximately 30 minutes and healing touch therapy over approximately 30 minutes with each course of chemotherapy 1-6 and hypnosis over 30-60 minutes during courses 1, 2, and 4.

Quality of life is assessed at baseline, during courses 3 and 6 of chemotherapy, and then 6 months after completion of study treatment.

After completion of study treatment, patients are followed at 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed epithelial ovarian, primary peritoneal or fallopian tube cancer, any pathologic type or stage, who will receive 6 cycles of chemotherapy.
* Patients must have signed an informed consent

Exclusion Criteria:

* Previous cancer other than skin cancer
* Previous chemotherapy experience
* Active substance abuse
* Schizophrenia
* Pregnant or lactating
A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer

The purpose of this study is to compare how long the participants are disease-free (progression-free survival) when treated with amivantamab and chemotherapy with 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, oxaliplatin (mFOLFOX6) or 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride (FOLFIRI) versus cetuximab and mFOLFOX6 or FOLFIRI in adult participants with Kirsten rat sarcoma viral oncogene homolog (KRAS)/ Neuroblastoma RAS viral oncogene homolog (NRAS) and v-Raf murine sarcoma viral oncogene homolog B1 (BRAF) wild type (WT) unresectable or metastatic left-sided colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Have histologically or cytologically confirmed adenocarcinoma of the left-sided colorectal cancer. Participants must have unresectable or metastatic disease
* Be diagnosed to have Kirsten rat sarcoma viral oncogene (KRAS), neuroblastoma RAS viral oncogene homolog (NRAS), and v-raf murine sarcoma viral oncogene homolog B (BRAF) wild-type (WT) tumor as determined by local testing
* Must agree to the submission of fresh tumor tissue
* Have measurable disease according to RECIST v1.1
* Have an eastern cooperative oncology group (ECOG) performance status (PS) of 0 or 1

Exclusion Criteria:

* Has medical history of (noninfectious) interstitial lung disease (ILD) /pneumonitis/pulmonary fibrosis or has current ILD/pneumonitis/pulmonary fibrosis, or where suspected ILD/pneumonitis/pulmonary fibrosis cannot be ruled out by imaging at screening
* Has known allergies, hypersensitivity, or intolerance to excipients of any of the following: (a) amivantamab or cetuximab, (b) any component of mFOLFOX6 and, (c) any component of FOLFIRI
* Has a prior or concurrent second malignancy other than the disease under study or one whose natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)
* Participant with known mismatch repair deficiency (dMMR)/ high microsatellite instability (MSI-H) status and human epidermal growth factor receptor 2 (HER2)-positive/amplified tumor
* Has prior exposure to any agents that target epidermal growth factor receptor (EGFR) or mesenchymal epithelial transition (MET)
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke

The ARCHIMEDES study (Anti-inflammatory and anti-thRombotic therapy with colCHicine and low dose rIvaroxaban for Major adverse cardiovascular Events reDuction in ischEmic Stroke) will be a randomized, double-blind, 2x2 factorial clinical trial, which will include at least 3000 and up to a maximum of 4500 patients with ischemic stroke without indication of oral anticoagulation.

In patients with ischemic stroke, within 14 days of symptom onset, to establish the efficacy and safety of two strategies in parallel: low-dose rivaroxaban and low-dose colchicine, compared with placebo.

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute ischemic stroke aged ≥18 years old who, regardless of etiology and mechanism, do not have a definitive indication for anticoagulation, and whose symptoms onset has been within the last 14 days;
* Receiving standard therapy for acute management of ischemic stroke;
* For patients treated with fibrinolytics, a minimum period of 24 hours after the infusion of the lytic drug is required for randomization into the study.

Exclusion Criteria:

* Modified Rankin score of 4 or more at randomization;
* Refusal to provide consent;
* Severe renal failure, with glomerular filtration rate (by CKD-EPI) estimated at \<15 mL/min/1.73 m2;
* Severe liver failure (child C);
* Indication for full-dose anticoagulation (for example, venous thromboembolism or atrial fibrillation);
* Previous hemorrhagic stroke or history of intracranial hemorrhage;
* Systemic treatment with a potent CYP 3A4 inhibitor (such as azole antifungals and protease inhibitors), or with a potent 3A4 inducer (such as rifampicin, phenytoin, phenobarbital, or carbamazepine);
* History of inflammatory bowel disease or chronic diarrhea;
* Prolonged treatment (\> 1 month) with immunosuppressants or systemic corticosteroids;
* History of recurrent pneumonia (3 or more hospitalizations in the last 12 months);
* Pregnancy or breastfeeding;
* Any other comorbidity other than stroke and CV disease (e.g., metastatic cancer) that, in the investigator's opinion, has a significant impact on the 12-month survival.
Contrast-Enhanced Ultrasound in Human Crohn's Disease

To determine if contrast enhanced ultrasound (CEUS) and shear wave elastography can accurately diagnose bowel wall inflammation and fibrosis in patients with known Crohn's disease.

Crohn's disease (CD) is an inflammatory condition that affects the intestinal tract (large and small bowels). Some patients with CD may get swelling of the intestinal tract (inflammation) or scarring of the intestinal tract (fibrosis). Fibrosis develops because of chronic injury. Both inflammation (swelling) and fibrosis (scarring) can cause the bowel to narrow, which can lead to the bowel becoming blocked. The long-term goal of this project is to develop new noninvasive radiology imaging tests that can show the difference between bowel wall inflammation and fibrosis. Currently there are no imaging tests that can do this reliably.

Current imaging methods (CT and MRI) that are ordered to help diagnose and follow-up CD are excellent at showing inflammation, but are not accurate for finding fibrosis. CT also exposes patients to small amounts of radiation, and both CT and MRI are costly. We are therefore studying ultrasound imaging, as it is more cost-effective and does not expose patients to radiation. CEUS uses microbubbles in a solution that are injected into a vein in one of the arms. This allows doctors to see the blood flow to parts of the body. This microbubble contrast agent (dye) is called Optison. Another imaging method, called shear wave elastography, uses sound waves to noninvasively measure the stiffness of structures in the body.

It is important to be able to tell the difference between inflammation and fibrosis in Crohn's disease, because narrowing of the bowel due to inflammation generally responds well to medications, whereas narrowing caused by fibrosis does not respond well to medications and may require surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients 10 years of age and older
* Have been diagnosed with small bowel Crohn's disease
* Are receiving medical therapy for Crohn's disease
* Are scheduled for surgery (bowel resection) OR
* Are scheduled for a clinically-indicated MR enterography (MRE)/MRI exam.

Exclusion Criteria:

* Patients under the age of 10
* Are pregnant or breast feeding
* Are significantly overweight - BMI \>35-40
* Have an inability to understand the consent
* Have prior allergic-like reaction or other adverse reaction to microbubble contrast agent
* Hypersensitivity to perflutren, blood, blood products or albumen
* Have a cardiac shunt
* Known unstable cardiac condition such as history of a heart attach, irregular heartbeat, congestive heart failure, etc.
* Known acute or chronic kidney disease, moderate/severe lung disease or acute or chronic liver disease
Coronary Artery Calcification Assessed on PET Scanner (PET : Positron Emission Tomography)

Calcification artery calcium (CAC) scoring is a valuable tool for determining the risk of major adverse cardiac events.

It was found that CAC can be quantitatively assessed, by manual scoring or using deep-learning, on low-dose non electrocardiogram-gated, contrast-enhanced or non-enhanced computed tomography (CT-scan) performed in association of PET acquisition, with a good agreement with standard scans.

The purpose of this study is to determine the impact of a systematic coronary artery calcification evaluation in patients undergoing flourine-18 fluorodeoxyglucose positron emission tomography/computed tomography (18F-FDG PET/CT) imaging to improve primary prevention of cardiovascular diseases.

A visual calcification artery calcium assessment will be made for each patient, dividing them into four groups: none, mild, moderate or heavy calcification artery calcium. When possible, a calcification artery calcium score will be computed.

Each patient will complete a questionnaire to collect risk factors, history of cardiovascular diseases and medications.


Eligibility Criteria:
Inclusion Criteria:

* Patients referred for a 18F-FDG PT/CT imaging
* Patients aged 18 and older

Exclusion Criteria:

* Patients who already participated in this study (in case of follow-up PET/CT scans)
* Unusable CT scan due to CT artifacts or poor-quality images
* Patients referred for a brain 18F-FDG PET/CT imaging
* Minors,
* Protected adults
* Pregnant or breastfeeding women