cyrilzakka/clinical-trials huggingface dataset:
The Associations Between the Gastric Mucosal Pathology and the Eradication Rate of H.Pylori :A Multicenter Study

Use the two-categorical variable , eradicate success or failure ,as a dependent variable, and analyze the influential factors by logistic regression.And then the statistically significant influencing factors like gastric mucosal pathology are obtained.We build a predictive model of the outcome of Hp eradication therapy based on significant influencing factors. The difference with p 0.05 is statistically significant.

The subjects who are naiive Hp infection patients recieved the Hp eradication therapy based on antimicrobial susceptibility test.Using success or failure of eradication as a dependent variable, analyze the influential factors by logistic regression.And then the statistically significant influencing factors like gastric mucosal pathology are obtained.We build a predictive model of the outcome of Hp eradication therapy based on significant influencing factors. The difference with p\<0.05 is statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* Patients, aged between 18 and 70 years old, with positive H. pylori infection that was not eradicated by previous therapies are included. The H. pylori infection is confirmed by the positive rapid urease test or 13C-breath test.

Exclusion Criteria:

* Patients with significant underlying disease including liver, cardiac, pulmonary, and renal diseases, neoplasia, coagulopathy and genetic diseases, history of gastric surgery, pregnancy, breast-feeding, active gastrointestinal bleeding, patient with peptic ulcer, the use of PPI, NSAID or antibiotics during the 4 weeks prior to enrolment, and previous history of allergic reactions to any of the medications used in this protocol. Patients previously treated with H. pylori eradication regimens or those unwilling to participate in the study were also excluded.
Fruquintinib Combined With Sintilimab and Chemotherapy in the Treatment of Non-Small Cell Lung Cancer

A phase II study to assess the efficacy and safety of Fruquintinib Combined With Sintilimab and Chemotherapy as a first-line treatment in patients with unresectable or metastatic advanced Wild-type Genotype non-squamous Non-small Cell Lung Cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntary provision of informed consent.
2. Males or females aged 18-75.
3. Histological or cytologically confirmed NSCLC, metastatic or non-resectable (stage IIIB-Ⅳ).
4. Not suitable for targeted therapy (patients with non-squamous NSCLC have no EGFR, ALK, gene mutation)
5. At least one lesion can be measured by imaging.
6. Have not received systemic treatment in the past.
7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
8. Life expectancy ≥ 12 weeks.
9. Female of childbearing age must have a negative pregnancy test (serum or urine) within 7 days before enrolment.

Exclusion Criteria:

1. Histological or cytologically confirmed small cell lung cancer (SCLC), including lung cancer mixed with SCLC and NSCLC.
2. Diagnosed with other malignant diseases other than NSCLC within 5 years.
3. Have participated in other interventional clinical research treatments now or within 4 weeks.
4. Have previously received multi-targeted kinase inhibitors therapy.
5. Have active autoimmune diseases requiring systemic treatment within 2 years.
6. Received systemic glucocorticoid therapy or immunosuppressive therapy within 2 weeks.
7. Clinically uncontrollable pleural effusion/abdominal effusion.
8. Vaccinated vaccines or attenuated vaccines within 4 weeks before the group;
9. Pregnant or breastfeeding females.
10. Other serious hazards to the safety of patients.
Comparing Risk and Severity of IRRs in Patients Premedicated With Cetirizine vs. Diphenhydramine Prior to Ocrelizumab

This 6-month randomized controlled pilot study will determine whether there is some evidence that cetirizine is better tolerated than diphenhydramine without an increase in Infusion-Related Reactions (IRRs) in subjects receiving ocrelizumab(OCR) for multiple sclerosis (MS).

Ocrelizumab was approved by the US Food and Drug administration in March 2017 for the indication of Relapsing Remitting Multiple Sclerosis (RRMS) and Primary Progressive Multiple Sclerosis (PPMS). The landmark studies used to gain approval found ocrelizumab (OCR) to be well tolerated, but that at least one Infusion-Related Reaction (IRR) occurred in about one-third of patients. Because of this, neurologists typically prescribe prophylactic premedication with 100mg of methylprednisolone, 1 gram of acetaminophen, and 50 mg of IV diphenhydramine. However, many patients experience extreme sedation that interferes with their lifestyle considerably.

This 6-month randomized controlled pilot study will determine whether there is some evidence that cetirizine is better tolerated than diphenhydramine without an increase in IRRs. Fifty-two patients, 26 patients per arm, will be randomized in a 1:1 ratio to receive cetirizine or diphenhydramine as premedication prior to OCR infusions on day 0 (1st half dose of 300mg), day 14 (2nd half dose of 300mg) and week 24 (1st full dose of 600mg).

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patient with relapsing or progressive forms of Multiple Sclerosis (MS), age 18 to 70 inclusive at the time of consent.
2. Able to understand the purpose, responsibilities and risks of the study and provide signed informed consent.
3. Naïve to ocrelizumab (OCR) and will receive OCR as part of standard of care for MS treatment.
4. No evidence, in the opinion of the investigators of significant cognitive limitation or psychiatric disorder that would interfere with the conduct of the study.
5. Estimated Expanded Disability Status Scale (EDSS) of ≤ 6.5 at screening.
6. Female patients of childbearing potential must practice effective contraception and continue contraception during the study.

Exclusion Criteria:

1. Any mental condition of such that patient is unable to understand the nature, scope, and possible consequences of the study.
2. Evidence of active hepatitis B infection at screening.
3. Patients with untreated hepatitis C, or tuberculosis. Patients who have history of Progressive multifocal leukoencephalopathy (PML) or known to be Human Immunodeficiency Virus (HIV) positive, per standard care.
4. Any persistent or severe infection.
5. Pregnancy or lactation.
6. Significant, uncontrolled somatic disease or severe depression in the last year.
7. Current use of immunosuppressive medication, lymphocyte-depleting agents, or lymphocyte-trafficking blockers.
8. Patients with any significant comorbidity that in the opinion of the investigator, would interfere with participation in the study.
9. Any known allergy or inability to tolerate diphenhydramine or cetirizine.
Lung Bioavailability and Total Systemic Exposure to Beclomethasone17MonoPropionate and Formoterol Across Two Strengths of NEXThaler Inhalation Powder

The study is aimed to assess the dose proportional total systemic exposure (when the administration is without the activated charcoal) to B17MP (active metabolite of BDP) and its lung bioavailability (when the administration is with the activated charcoal) after single inhalation of CHF 1535 NEXThaler DPI at two dose strengths.

At the same time, the study will assess if the lung deposition and the total systemic exposure to Formoterol is affected by increasing doses of BDP.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of asthma as defined by Global Initiative for Asthma (GINA) 2011
* Asthmatic patients already treated with low daily doses of Inhaled Corticosteroids (ICS) (eg budesonide or equivalent lower than 400 mcg/day) or low dose of ICS/Long Acting Beta2 Agonists (LABA) fixed combinations.
* Patients with Forced Expiratory Volume in 1 sec (FEV1) \>= 70 % of predicted values
* Non or ex-smokers
* Body Mass Index (BMI) \>= 18.5 and \<= 32 kg/m2

Exclusion Criteria:

* Pregnant or lactating women unless using acceptable methods of contraception
* Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
* History of near fatal asthma
* Patients with abnormal QTcF at screening Visit
* Hospitalization due to asthma exacerbation within 4 weeks prior to the screening visit or during the run-in period.
* Lower respiratory tract infection within 4 weeks prior to the screening visit or during the run-in period.
* History of drug addiction or excessive use of alcohol ;
* Diagnosis of restrictive lung disease.
* Patients treated with oral or parenteral corticosteroids in the previous 2 months before the screening visit (3 months for parenteral depot corticosteroids)
* Significant medical history or any laboratory abnormality indicative of a significant underlying condition
Efficacy of an Antibacterial Toothpaste and Patients' Satisfaction

The primary objective of this randomized controlled clinical trial (RCCT) will be to compare the efficacy in reducing the quantity of Streptococcus mutans (S. Mutans) in saliva of a recently introduced toothpaste compared to a commercially available toothpaste. The secondary outcomes will be to assess patients' impression of the toothpastes (in terms of taste, satisfaction etc.), and to investigate potential changes in dentin hypersensitivity, plaque formation and gingival inflammation.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with minimum 20 teeth;
2. Good oral hygiene level (gingival bleeding index not exceeding 20%)
3. Patients willing to participate in the study and able to sign an informed consent

Exclusion Criteria:

1. Tooth anomalies (amelogenesis imperfecta, dentinogenesis imperfecta etc.);
2. Intrinsic stain (fluorosis);
3. Caries lesions;
4. Advanced periodontal disease (probing \>2, spontaneous gum bleeding, tooth mobility \>1);
5. Smokers;
6. Use of orthodontic devices;
7. Use of antibiotics in the last 3 months;
8. Use of antibacterial mouth rinses in the last 3 months;
9. Potential allergies;
10. Drug and alcohol abuse;
A PROpensity Score Matching Analysis on ENDovascular vs Open Thoraco-Abdominal Aortic Aneurysm Repair (PRO-ENDO TAAA Study)

The purpose of the registry is to compare the surgical and endovascular approaches to the treatment of thoracoabdominal aortic aneurysms.

The purpose of the study is to compare the surgical and endovascular approaches to the treatment of thoracoabdominal aortic aneurysms. In particular, the study aims at comparing the short- and mid-term mortality, morbidity and reintervention rate after open surgery or endovascular repair of thoracoabdominal aortic aneurysms in comparable cohorts of patients according to preoperative characteristics and evaluating the cost-effectiveness of both techniques, according to the EUnetHTA core model.

The study results will contribute to the creation of a HTA Report regarding endovascular technology to treat thoracoabdominal aortic aneurysms which will be evaluated by the appropriate Health Authorities.

Eligibility Criteria:
Inclusion Criteria:

* Patients affected by a thoracoabdominal aortic aneurysm who received an open surgical repair (aneurysmectomy and aortic reconstruction with a surgical graft) or endovascular repair (with off-the-shelf or custom-made Fenestrated/Branched-Endovascular Aortic Repair - F/BEVAR) between January 2013 and June 2021 at San Raffaele Hospital (Vascular Surgery Unit)
* Adult patients ≥18 years
* The patient is able to understand and sign the informed consent approved by the Ethics Committee of the San Raffaele Hospital

Exclusion Criteria:

* Patients treated with a hybrid approach (open surgical retrograde revascularization of renovisceral arteries followed by aneurysm exclusion with endograft)
* Patients treated with other endovascular techniques besides fenestrated or branched technology (e.g., physician-modified endografts, parallel grafts).
* Patients with a juxtarenal or pararenal aortic aneurysm
* Patients treated with F/BEVAR for a visceral artery patch aneurysm after open thoracoabdominal repair
Study Evaluating Intervention in the Development of Clinical Research in Non-Academic Health Institution (ERNU)

This study evaluates the interventions of the Cancéropôle Nord-Ouest in the development of clinical research in non-academic health institution. The randomization, in open label,determines the duration of the interventions. Half of participants will receive the interventions during 2 years, while the other half during 1 year.

French National recommendations ask to increase the accessibility of patients to clinical trials. But this accessibility is far from the optimal care in non-university healthcare institutions (public and private hospital). These non-academic healthcare facilities support at national level about 60% of chemotherapy and 70% of radiotherapy, but only 17% of the inclusions in trials.

A dissociation exist between a care package guaranteed on quality criteria (criteria to obtain the capacity to treat the cancers in healthcare institution) distributed all over the country, and the research, mainly concentrated in few referral centers (University hospital and French Comprehensive Cancer Centers).

Clinical trials allow patients to have early access to new treatments, optimal and formalized information, and supported by physicians in connection with a strict protocol for patients included.

Several studies have shown the existence of geographical and socio-economic determinants for access to reference centers and for the duration of survival of cancer patients. In France, it was found that for patients with gastrointestinal cancer, the remoteness of the place of residence compared to the nearest referral center and a higher level of deprivation decreased the probability of being supported in a reference center.

The hypothesis of the ERNU study is that aid from the Cancéropole Nord-Ouest facilitates clinical research activity resulting in a significant development of inclusions in non-university centers of the french north-west inter-region with an influence on the social and geographical inequalities recruitment.

Eligibility Criteria:
Inclusion Criteria:

* French Health institutions of the Basse-Normandie, Haute-Normandie, Nord-Pas-de-Calais and Picardie.
* Health institutions non-academic public and private.
* Health institutions authorized to treat cancer.

Exclusion Criteria:

* N/A
Seocalcitol Versus Placebo in the Adjuvant Treatment of Hepatocellular Carcinoma

To evaluate the efficacy of Seocalcitol in prolonging time to relapse following intended curative resection or percutaneous ablative treatment, i.e. percutaneous ethanol injection(s), percutaneous acetic acid injection(s), percutaneous microwave coagulation therapy, or percutaneous radiofrequency ablation for hepatocellular carcinoma (HCC).


Eligibility Criteria:
Inclusion Criteria:

* Hospital in- or out patients
* Either sex
* 18 to 75 years of age
* With hepatocellular carcinoma treated successfully with surgical resection or percutaneous ablative treatment within 4 and 8 weeks, respectively, prior to inclusion.
* All patients must give their signed informed consent to join the study.

Exclusion Criteria:

* Patients previously treated with any anti-cancer therapy for HCC except for surgical resection and percutaneous ablative therapy
* Patients treated with chemotherapy or other anti-cancer therapy (except surgical resection or percutaneous ablative treatment) in the previous 4 weeks
* Patients with another primary tumor except basocellular carcinoma of the skin or in situ carcinoma of the cervix within the last 2 years
* With a history of renal stone(s)
* With a life expectancy \< 3 months
* WHO performance status 3 or 4.
* Patients with hypercalcemia (ionised serum calcium \> 1.35 mmol/l or albumin corrected serum calcium \> 2.68 mmol/l), previous/current calcium metabolic disease, taking calcium-lowering therapy or medication known to affect systemic calcium metabolism, or with marked laboratory abnormalities.
* Patients with recurrent hepatocellular carcinoma, with known extrahepatic metastases, Okuda stage III disease and patients with a Child-Pugh score of C are also excluded.
Baricitinib in Idiopathic Granulomatous Mastitis

This study will explore the mechanism of targeted drug in treatment of idiopathic granulomatous mastitis, and clarify the clinical classification and corresponding markers.

This study is aim to explore the mechanism of baricitinib in regulating the occurrence and development of idiopathic granulomatous mastitis, as well as the clinical classification and potential markers of idiopathic granulomatous mastitis. The target population of interest in this study is patients with non-lactating mastitis, which requires core needle biopsy pathology to indicate mastitis or biopsy pathology of palpable mass indicates chronic interstitial cell infiltration. Measurable lesions are required. The primary end point was the clinical complete remission rate, and the secondary end point was the degree of focus reduction, the recurrence rate within 12 months after drug withdrawal, the degree of inflammation markers decline, and the toxicity and side effects of the drug.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be between 18 years of age and 70 years of age
* Female patients who have pathologically documented idiopathic granulomatous mastitis that:

  1. Non-lactating mastitis
  2. Core needle biopsy pathology to indicate mastitis or biopsy pathology of palpable mass indicates chronic interstitial cell infiltration.
  3. Special immunohistochemical is negative \[Acid fast dyeing, Mayer's dyeing, PAS, fungi (FISH), Tuberculosis (FISH), hexamine silver\], excluding the possibility of infection such as fungi, tuberculosis or other corynebacterium.
* Measurable lesions are required(mainly breast ultrasound can detect lesion with low echo).
* ECOG Performance Status of 0 or 1,Karnofsky score is greater than 80

Exclusion Criteria:

* Pregnant women, lactating women or those who have a fertility plan within 3 years; Informed consent does not meet the requirements (if it is not in person, and the authorization consent is missing).
* Core needle biopsy pathology indicates that inflammation caused by tuberculosis and other pathogenic bacteria infection or any of the above immunohistochemical staining items are positive; Lung (HR) CT showed that tuberculosis or tumor could not be excluded; Misdiagnosis; No test record; There is no record of return visit.
* Due to the use of other potential therapeutic drugs, such as glucocorticoids or anti-tuberculosis drugs, the effectiveness evaluation of baricitinib cannot be carried out; Those who have been diagnosed as malignant tumors, have been treated or are being treated; Those who have serious complications, such as cardiac or pulmonary insufficiency, severe cerebral infarction, and cannot tolerate the treatment.
Effect of Transpulmonary MP on Prognosis of Patients with Severe ARDS Treated with VV-ECMO

Venovenous extracorporeal membrane oxygenation (VV-ECMO) is a salvage treatment for severe acute respiratory distress syndrome (ARDS). With the large-scale implementation of VV-ECMO in critical care medicine departments in China, significant progress has been made in treating severe ARDS. However, the patient mortality rate remains high. The pathophysiological essence of ARDS is an imbalance between the body's oxygen supply and demand, causing tissue and cell hypoxia, organ dysfunction, and even death. The VV-ECMO treatment process still requires mechanical ventilation assistance. However, inappropriate mechanical ventilation settings can lead to ventilator-related lung injury (VILI). In recent years, mechanical power has gradually attracted everyone's attention and is considered the cause of VILI. The transpulmonary mechanical power is more accurate to the energy directly performed to the lung tissue. Transpulmonary mechanical energy has a specific value in judging the prognosis of mechanically ventilated patients, but its clinical significance in treating patients with VV-ECMO is unclear. This study aimed to explore the value of transpulmonary mechanical power in predicting the prognosis of patients with severe ARDS patients treated with VV-ECMO.


Eligibility Criteria:
Inclusion Criteria:

1. Meet the diagnostic criteria of Berlin's definition for ARDS;
2. Receiving VV-ECMO support.

Exclusion Criteria:

1. Patients had been on high pressure (Ppeak \>35 cm H2O) and a high fraction of inspired oxygen (FiO2\>0.8) ventilation for \>7 days;
2. Patients had a contraindication to heparinization;
3. Patients had an irreversible neurological injury;
4. Patients had severe chronic lung disease with life expectancy \<6 months.
Clinical Validation for SpO2 Function of Masimo INVSENSOR00069

Assess the accuracy of INVSENSOR00069's peripheral oxygen saturation (SpO2) against contemporaneous measurement from arterial blood gas (ABG) analysis.


Eligibility Criteria:
Inclusion Criteria:

Influenced by study design:

* Subject is 18 to 50 years of age.
* Subject weighs a minimum of 110 lbs.
* Hemoglobin value ≥ 11 g/dL.
* Baseline heart rate ≥ 45 bpm and ≤ 90 bpm.
* Systolic blood pressure ≤ 140 mmHg and ≥ 90 mmHg and diastolic blood pressure ≤ 90 mmHg and ≥ 50 mmHg. If systolic blood pressure is lower than 100 mmHg and/or diastolic blood pressure is lower than 60 mmHg, subject passes an orthostatic blood pressure test.
* CO value ≤ 3.0% FCOHb.
* Subject is comfortable to read and communicate in English\*. \*This is to ensure the subject can provide informed consent (as study materials are currently available in English only) and can comply with study procedures.

Exclusion Criteria:

Influenced by device warning labels:

* Subjects with a skin condition affecting the digits, where the sensor is applied, which would interfere with the path of light (e.g., psoriasis, vitiligo, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, etc.).
* Subjects with nail polish or acrylic nails on the digits where sensor needs to be applied, who opt not to remove them.
* Subject has hemoglobinopathies or synthesis disorders (e.g., thalassemia, sickle cell disease).
* Subject has a peripheral vascular or vasospastic disease (e.g., Raynaud's disease).

Influenced by study design/environment:

* Subjects who do not pass the health assessment for safe participation in the study procedures.
* Difficulty inserting an intravenous line in the subject's hand or arm and/or an arterial line in the radial artery of the subject's wrist.