cyrilzakka/clinical-trials huggingface dataset:
IM Ketorolac vs Cambia for the Acute Treatment of Severe Migraine

This research will be conducted to see if the oral drug Cambia is as effective in relieving severe migraine headaches as the injectable drug ketorolac.

The treatment of severe migraine often requires a patient office visit or treatment in the ER or urgent care setting. This is due to the minimal efficacy of PO treatments once migraine is severe, and therefore the need for parenteral treatments. IM Ketorolac is one mainstay of parenteral treatment. There is an unmet need for effective at-home treatment regimens for severe migraine. Despite FDA approval of Cambia for acute migraine treatment, insurance is reticent to cover the treatment due to higher cost in comparison to generic diclofenac tablets, despite superior efficacy of Cambia in comparison to generic diclofenac tablets (Diener, Cephalalgia 2006). One objective of this study would be to provide rationale to justify the insurance coverage of this treatment in comparison to generic tablets, because at home treatment is less costly than office visit or emergency department visit to receive IM ketorolac.

A previous study of Cambia demonstrated that this formulation of diclofenac potassium for oral solution is effective in reducing pain intensity within 30 minutes, which may be related to the 15-minute Tmax associated with this formulation. The rapid-onset benefits were sustained through 24 hours post-treatment (Lipton, Cephalalgia 2010)

Eligibility Criteria:
Inclusion Criteria:

* Patients who meet IHS criteria for migraine
* Age 18 to 65
* At least 2 migraine attacks per month
* Able to give written consent
* Willing to complete the entire course of the study
* Current headache duration greater than or equal to 36 hours

Exclusion Criteria:

* Pregnant or nursing
* Significant medical or psychiatric disease
* History of gastritis, gastric ulcer, GI bleed
* Renal insufficiency
* Hepatic insufficiency
* History of opioid dependence within the last 10 years or currently
* Any current or prior use of DICLOFENAC POTASSIUM POWDER FOR ORAL SOLUTION (CAMBIA)
* Past allergic reaction to DICLOFENAC or other NSAIDs
Study Evaluating Techniques for Measuring Tear Production

This will be a vehicle-controlled, masked, randomized study conducted at a single site in the United States. All participants enrolled will have Dry Eye Disease (DED). The study will consist of 2 Visits. At Visit 1, eligibility will be assessed at Screening. All eligible subjects will then be enrolled and randomized to one of two treatment groups (1:1): active (0.003% AR-15512) or control (AR-15512 vehicle). Subjects in each treatment group will then be randomized 1:1 to which Visit (Visit 1 or 2) anesthetic will be used with the Schirmer test.


Eligibility Criteria:
Inclusion Criteria:

* Have used, and/or desired to use artificial tears for DED symptoms within 6 months prior to Visit 1
* Within the last year from Visit 1, have a documented Schirmer test with or without topical anesthesia score ≥ 2 and ≤ 10 mm/5 min
* Within the last year from Visit 1, have documented symptoms of DED
* Corrected Visual Acuity (Snellen) 20/200 or better in both

Exclusion Criteria:

* Use of artificial tears within 2 hours prior to Visit 1
* Use of ocular cyclosporine or other prescription ophthalmic solution for DED (e.g., Restasis®, Cequa®, Xiidra®) within 30 days of Visit 1 or anticipated use during the study period.
* Regular use of any topical ocular non-DED medication or use of a topical ocular non-DED medication within 2 hours of Visit 1
* Use of contact lenses in either eye within 7 days prior to the Screening visit or planned use during the study
* Punctal or intracanalicular plug present in either eyelid or anticipated plug insertion or occlusion at any time during the study.
Correlation Between Complications After Pancreaticoduodenectomy and Microbiota

Pancreaticoduodenectomy is the most performed pancreatic surgery for malignant or premalignant tumors of the region of the head of the pancreas. Its post-operative morbidity is very high, over 40%. There is very little data on the impact of microbiota on complications after pancreatic surgery. The purpose of this research is to study the correlation between the microbiota (fecal, blood, oral, biliary, pancreatic and intestinal microbiota) and the postoperative complications in patients who undergo pancreaticoduodenectomy.

After pancreaticoduodenectomy, the post-operative complications can be surgical (pancreatic fistula, gastroparesis) but also infectious, digestive (diarrhea) and lead to malnutrition. They are responsible for prolonged post-operative hospitalizations, impaired quality of life of patients and induce a delay in the implementation of adjuvant chemotherapy, or even an impossibility to achieve it. The absence of adjuvant chemotherapy adversely affects the prognosis of patients, by increasing the rate of recurrence and decreased survival. There is therefore a real oncological benefit in finding solutions to reduce the number and severity of these complications. A change in post-operative microbiota composition has been shown to play a role in the development of post-surgical anastomotic fistulas in colorectal cancer. Despite their importance, there is very little data on the impact of microbiota on complications after pancreatic surgery. We postulate that microbiota variations could have an impact on early and late post-operative complications after pancreaticoduodenectomy. Any patient hospitalized at the Toulouse University Hospital with an indication of a pancreaticoduodenectomy will be offered to participate in this study. Microbiota analysis will be carried out on different samples: blood, stool and saliva samples will be collected during the surgery, between J5 and J10 (post-operative during hospitalization) and at 3 and 6 months after the surgery. Bile, pancreatic and intestinal mucosa samples will only be collected during the surgery. Complications will be collected throughout this study. This study will not create any additional constraints on patient management. The follow-up period will be 6 months. This follow-up period will be fixed for all patients included. The microbiota analyses will be centrally determined during the study.

Eligibility Criteria:
Inclusion Criteria:

* Patient hospitalized at the Toulouse University Hospital with an indication of a pancreaticoduodenectomy
* Patient aged over 18 years old
* Patient having given his written consent
* Patient with social insurance coverage

Exclusion Criteria:

* Patient for whom the pancreaticoduodenectomy was not realized (exploratory laparotomy or other surgery)
Risk Stratification of Patients Presenting With Upper Gastrointestinal Bleeding to the Emergency Department Using AIMS65 Score and Red Cell Distribution Width

The rationale of this study in UGIB patients is to assess whether the prediction of mortality and morbidity using AIMS65 score improves when used in combination with RDW in the emergency department setting.

UGIB is a ticking time-bomb and emergency physicians are challenged to accurately assess risk, and aggressively manage patients with gastrointestinal bleeding within the stipulated time in the confines of emergency department. If not managed properly, it is associated with high mortality.

Various clinical prediction scores help in risk stratifying such patients. Among the scores, AIMS65 score is the easy to use score and has good mortality predictive accuracy. RDW, once thought as marker of chronic blood loss has recently been identified as a good prognostic indicator as well as good predictor of mortality in conditions where there is acute blood loss.

Both AIMS65 score and RDW value have been used separately as a predictor of morbidity and mortality in patients with UGIB. But there are not much studies so far evaluating their combined role as marker of predicting mortality as well as high risk among UGIB patients. Hence there is a need for a study to know the predictive value of combination of AIMS6S score and RDW in patients presenting to ED with symptoms of UGIB not been much studies comparing the relationship between RDW and upper GI bleed.

The rationale of this study in UGIB patients is to assess whether the prediction of mortality and morbidity using AIMS65 score improves when used in combination with RDW in the emergency department setting.

Eligibility Criteria:
Inclusion Criteria:

1. All patients presenting to ED with UGIB
2. Age more than 18 years of age

Exclusion Criteria:

1. Patients not consenting to study
2. Patients with known hematological disorders
3. Patients in which endoscopy or blood transfusion is done outside
4. Patients in which RDW value and laboratory parameters required for AIMS65 score are not available.
Ranibizumab Intravitreal Injections Versus Sham Control in Patients With Branch Retinal Vein Occlusion (BRVO)

Provided efficacy and safety data on intravitreal injections of ranibizumab 0.5 mg in patients with visual impairment due to macular edema secondary to BRVO


Eligibility Criteria:
Inclusion Criteria:

• Patients with visual impairment secondary to branch retinal vein occlusion (BRVO) with a BCVA between 19 and 73 letters in one eye and at least 35 letters in the other eye.

Exclusion Criteria:

* Pregnant or nursing women or women of child bearing potential without unless using an effective contraception
* Stroke or myocard infarction within 3 months prior to study
* History of malignancy within the past 5 years
* Uncontrolled hypertension
* Active infection or inflammation in any eye
* use of corticosteroids for at least 30 days in the last 6 months
* treatment with anti-angiogenic drugs in any eye within last 3 months
* Panretinal or focal/drid laser photocoagulation within the last few months
Salvage Therapy With High Dose Oral Clarithromycin in Relapsed or Refractory Extranodal Marginal Zone Lymphoma

This is a prospective, phase II study on the activity and tolerability of high dose (2 g/day) oral clarithromycin for the treatment of relapsed or refractory extranodal marginal zone lymphoma.

A 6-month regimen of oral clarithromycin has been associated with a 35% ORR in patients with relapsed/refractory marginal zone B-cell lymphoma. Responses were more common among patients with conjunctival lymphoma. This could be explained at least in part by the elimination of clarithromycin by tears, suggesting that a higher tumor bioavailability of this antibiotic could result in a higher activity. Thus, a higher dose of clarithromycin could be associated with a higher tumor bioavailability in tissues other than the conjunctiva.

Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed diagnosis of extranodal extra-gastric marginal zone cell B lymphoma or gastric Helicobacter pylori positive lymphoma refractory to conventional antibiotic therapy, or H. pylori negative
* at least one measurable lesion
* relapsed or refractory lymphoma after systemic (chemotherapy, immunotherapy, antibiotic) or local (surgery or radiation) therapy
* ECOG PS \</= 3
* no prior antibiotic therapy within 3 months before enrollment

Exclusion Criteria:

* HIV 1-2 infection
* concomitant conventional or experimental antitumor therapy (chemotherapy, radiotherapy, immunotherapy, corticosteroids)
* severe inadequate liver (AST \</=3 ULN, ALT \</= 3 ULN, bilirubin \</=3 ULN) or renal (creatinine \</= 1.5 ULN) function
* allergy to macrolides
* concomitant malignant neoplasms within prior 5 years (with the exclusion of basal cell carcinoma, in situ spinocellular carcinoma of skin and cervix)
Drug Sensitivity Correlation Between Patient-Derived Organoid Model and Clinical Response in NSCLC Patients

This clinical study aims to evaluate the feasibility to predict clinical response of target therapy or chemotherapy drugs based on the ex vivo drug sensitivity data using patient-derived organoids.

Methods - Open label single arm observatory comparison experiment

1. Enrolled patients (before or after surgery) were treated with chemotherapy or target therapy. The medication regime and treatment cycle were decided based on the clinical guideline and evidence-based medicine. This clinical study will not affect the treatment plan of the patients.
2. The resection tissue or biopsy tissue of NSCLC will be collected, and subject to ex vivo 3-D culture to establish patient-derived tumor organoid models, which will be used for drug sensitivity test.
3. The patient-derived organoid-based drug sensitivity test will be compared with clinical treatment data of chemotherapy or target therapy, followed by correlation analysis.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years old or more;
* Late stage NSCLC patients, with tumor invasion confirmed by histopathology analysis. Metastasis of axillary lymph nodes and other region lymph nodes are confirmed with histopathologic or cytopathologic analysis;
* Accessible to biopsy and/or surgery sample of metastasis and/or primitive tumor;
* No clinical evidence of other malignancy, unstable complication or uncontrolled infection;
* Life expectancy \> 12 months.
* Informed and signed consent by the patient.

Exclusion Criteria:

* Not accessible to biopsy and/or surgery sample;
* Patient already enrolled in another clinical trial with another first line of chemotherapy;
* Unmeasurable locally advanced (incurable) or metastatic lesion(s), according to RECIST 1.1 criteria;
* Women who are pregnant, plan to become pregnant or are lactating during the study;
* Elevation of carcinoembryonic antigen (CEA) observed without distal metastases found;
* Have some kind of contraindications for chemotherapy and targeted therapy: cardiovascular and cerebrovascular diseases; liver and kidney function deficiency; hematological system diseases; clinician consider the patients are not suitable for chemotherapies or target therapies;
* Have other malignant tumor previously;
* Have surgical contraindications: anesthesia taboo; surgery unresectable extensive lesions;
* State of health can't finish the study;
* Patient already enrolled in another clinical trial with another anti-cancer therapy or plan to participate in other clinical study.
* No self-determination or refuse to participant.
* With unlisted exclusion criteria but are considered not suitable for the clinical study by researchers.
Continuous or Intermittent Extension of Adjuvant Pyrotinib for Invasive HER2-positive Breast Cancer

This is a prospective, randomised, controlled, multicentre study to compare the efficacy and safety between continuous or intermittent extension of adjuvant pyrotinib in invasive human epidermal growth factor receptor 2 (HER2)-positive breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 and ≤70 years;
* Histologically confirmed invasive HER2 positive breast cancer;
* Duration from random time to the last use of trastuzumab or T-DM1 ≤3 years;
* Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1;
* Adequate organ functions.

Exclusion Criteria:

* Metastatic disease (Stage IV);
* Gross residual disease remaining after mastectomy or positive margins after breast-conserving surgery;
* Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption;
* Treated or treating with anti-HER2 tyrosine kinase inhibitor;
* Less than 4 weeks from the last clinical trial;
* History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation;
* Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test; Female patients of childbearing age that are reluctant to take effective contraceptive measures throughout the trial period;
* Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study.
Patient-Reported Effectiveness and Safety of Etoricoxib in Osteoarthritis (OA)(0663-113)

The purpose of this study is to collect disease burden of OA and the effectiveness and patient satisfaction of treatment by Etoricoxib in the normal practice setting.


Eligibility Criteria:
Inclusion Criteria:

* Must Be Over 20 Years Of Age, Regardless Of Sex
* Must Have A Diagnosis Of OA That Requiring Treatment
* Patients Must Have Taken an NSAID, Cox-2 Or Opioids On The Majority Of Days During The Last 4 Weeks Before Enrollment Who Are Intolerant (Due To Gastrointestinal Adverse Events) Or Inadequately Respond To Current Therapy (Vas \>= 40 mm On A Pain Scale From 0-100 mm)
* Excluding Osteoarthritis, The Patient Is Judged To Be In Otherwise General Good Health Based On Medical History, Physical Examination, And Routine Laboratory Tests
* Must Agree To Participate Voluntarily In The Study
* Must Have The Capacity To Understand And Answer The Questionnaires Used In The Study
* Must Agree To Return For A Follow-Up Visit With The Treating Physician Four Weeks After The Initiation Of Treatment With Etoricoxib
* Patient Is Willing To Sign Informed Consent Form

Exclusion Criteria:

* Under 20 Years Of Age
* Severe Hepatic Insufficiency (Child-Pugh Score \> 9)
* Advanced Renal Insufficiency (Creatinine Clearance \< 30 Ml/Min)
* Any Contraindication Or Warning Or Precaution As Mentioned In The Approved Study Drug Package Insert
* Gi Ulcer With Active Bleeding Present At Study Enrollment
* Patient Has A Recent History Of Stroke, Myocardial Infarction Or Transient Ischemic Attack (Within The Previous 2 Years)
The Effect of Podcast Training on Birth Fear in Couples: A Randomized Controlled Trial

Birth fear refers to intense feelings of anxiety, fear, and worry regarding the childbirth process, often arising from concerns about physical pain, complications, or uncertainty about the baby's health. Many women experience this fear during pregnancy, which, in some cases, may develop into a clinical condition known as tokophobia (Sharma \& Sharma, 2023). Birth fear can increase stress levels, disrupting the mother's hormonal balance, which may prolong labor, increase the risk of complications, and negatively impact fetal development. Additionally, it can lead to issues such as loss of self-confidence, anxiety, and depression in the mother, while causing communication problems and lack of support between partners. Birth fear affects not only the labor process but also the postpartum period, potentially leading to postpartum depression, trauma, and difficulties in mother-infant bonding. All these factors can adversely impact the psychosocial well-being of both women and couples. Therefore, it is crucial to develop interventions aimed at recognizing and reducing birth fear (Sarella et al., 2024).

Podcasts, with their accessibility, low cost, and user-friendly structure, allow individuals to access health-related information more easily and personalize the educational process, making it more effective. These factors make podcasts a valuable tool, especially in areas that require emotional and cognitive intervention, such as birth fear. While birth fear is a significant psychological factor influencing the anxiety of women and their partners regarding the childbirth process, there are limited intervention-focused studies targeting couples in this area. Although various methods have been proposed in the literature to reduce birth fear, data on the effectiveness of digital educational tools like podcasts in this domain is insufficient. This research aims to fill an important gap by evaluating the effect of a podcast series on birth fear in couples. The purpose of this study is to examine how a podcast series focused on birth fear impacts birth fear, anxiety, and postpartum depression in couples.

Eligibility Criteria:
Inclusion Criteria:

19-35 years old married primiparous 2nd trimester pregnant women

Exclusion Criteria:

Pregnant women with risky pregnancies illiteracy problems with internet access visual and hearing impairment
Topical Timolol 0.5% Solution for Proliferating Infantile Hemangiomas

The purpose of this study is to learn about a new potential use for topical timolol 0.5% aqueous solution that may help treat small uncomplicated infantile hemangiomas. This study would examine whether topical timolol could be a potential therapy.

At the first visit, subjects will fill out a questionnaire that asks about the child's history and the hemangioma. Photographs and measurements will be taken at this and each subsequent visit. At the first visit, subjects will have a physical exam, including vital signs, height and weight. An EKG will also be done. Study drug will be dispensed and instructions given. Half of the subjects will receive a placebo. This is a blinded randomized study. Follow-up visits will be weekly for the first two weeks (three visits total including the first visit), then monthly until the study is over. Photographs and measurements will again be taken at each visit. Subjects will be asked to evaluate the size and the color of the hemangioma against the first photographs and fill out forms regarding any changes in behavior and asked about any side effects.

Eligibility Criteria:
Inclusion Criteria:

Infants 1 month to 8 months of age with infantile hemangioma (IH) that are 3 cm or less on the scalp, trunk, or extremities.

Exclusion Criteria:

1. Subjects with facial, genital, perianal, hand, finger, feet, or toe IH
2. Subjects with PHACES (plaque-like hemangioma on the face awaiting imaging) syndrome (proven) or suspected PHACES .
3. Subjects with IH measuring more than 3cm in size or ulcerated.
4. Children with a history of hypersensitivity to beta blockers.
5. Children with a personal history of asthma.
6. Children with known renal impairment.
7. Children with known cardiac conditions that may predispose to heart block
8. Personal history of hypoglycemia
9. Children on medications that may interact with beta blockers