cyrilzakka/clinical-trials huggingface dataset:
Rollover Study of Ivacaftor in Subjects With Cystic Fibrosis and a Non G551D CFTR Mutation

The purpose of this study is to evaluate the safety of long-term ivacaftor treatment in participants with cystic fibrosis (CF) from Studies 110 (NCT01614457), 111 (NCT01614470), and 113 (NCT01685801).

Ivacaftor is the first Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) modulator to show an improvement in CFTR function and clinical benefit in participants with CF. Results from Phase 3 studies (NCT00909532 \[Study 102\] and NCT00909727 \[Study 103\]) showed that ivacaftor is effective in the treatment of participants with CF who have the G551D-CFTR mutation, as evidenced by sustained improvements in CFTR channel function (measured by reduction in sweat chloride concentration) and corresponding substantial, durable improvements in lung function, pulmonary exacerbations, respiratory symptoms, and weight gain. Ivacaftor was also well tolerated, as evidenced by the rates and reasons for premature discontinuation and results of safety assessments.

Ivacaftor (Trade Name Kalydeco; 150 mg tablets) was initially approved in the United States for the treatment of CF in participants 6 years of age and older who have a G551D mutation in the CFTR gene.

Eligibility Criteria:
Inclusion Criteria:

* Participants from Study 110 or Study 111 entering the ivacaftor arm must have completed the assigned study drug treatment duration in the previous study.
* Participants from Study 113 entering the ivacaftor arm must have completed all study related treatments through the Follow-up Visit and met the Study 113 responder criteria during the previous study.
* Participants entering the observational arm must have completed at least 4 weeks of study drug treatment in their previous study (Study 110 or Study 111), must have completed the previous study but do not wish to enroll in the ivacaftor arm, or must have completed the previous study but do not meet the inclusion criteria of the ivacaftor arm.
* Participants of childbearing potential entering the ivacaftor arm must not be pregnant.
* Participants entering the ivacaftor arm must be willing to comply with contraception requirements.

Exclusion Criteria (Ivacaftor Arm Only):

* History of any illness or condition that might confound the results of the study or pose an additional risk in administering ivacaftor to the Participant.
* Use of moderate or strong inhibitors or inducers of cytochrome P450 (CYP) 3A.
* Evidence of cataract or lens opacity at or before the Day 1 Visit.
Sonendo GentleWave™ System for Treatment in Molar Teeth Requiring Root Canal Therapy

A prospective, literature controlled, clinical study evaluating healing rates for the Sonendo GentleWave System in the treatment of 1st and 2nd molars indicated for root canal therapy.

A prospective, non-significant risk device, literature controlled, study evaluating healing rates for the Sonendo GentleWave System in the treatment of 1st and 2nd molars indicated for root canal therapy.

All patients will receive root canal therapy with the Sonendo GentleWave System. All patients will be followed for 24 months post procedure.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 75 years of age
* Indicated for root canal therapy
* First or second molar
* Signed informed consent form

Exclusion Criteria:

* Poor oral hygiene
* Class II or III mobility
* Open or incompletely formed root apices
* Vertical fracture, horizontal fracture, or perforation below the Cemento-Enamel Junction (CEJ)
* Previous pulpectomy or root canal therapy

Note: Additional exclusion criteria may apply.
18776 - Human Photoallergy Test

To evaluate the potential of a test material to produce a photoallergic response.


Eligibility Criteria:
Inclusion Criteria:

* be male or female between the ages of 18 and 60 inclusive;
* be lightly pigmented (Fitzpatrick Skin Type I, II, III);
* have read and signed the written Informed Consent Form and have completed a Health Insurance Portability and Accountability Act (HIPAA) Authorization Form in conformance with 45CFR Parts 160 and 164;
* be in general good health as determined by the subject's medical history and in the discretion of the investigator;

Exclusion Criteria:

* have a visible sunburn;
* have a history of sun hypersensitivity/photosensitivity or photosensitive dermatoses;
* have a known hypersensitivity or allergy against any of the active and non-active ingredients of the investigational products.
* subjects who are employees of the CRO and/or Bayer or is a household member of an employee
The Severity Assessment Model for AECOPD With Combination of Disease and Syndrome

The establishment of the AECOPD severity assessment model can quickly and accurately evaluate the condition, which is of great significance for standardizing diagnosis and treatment, improving efficacy, and improving prognosis. At the same time, it can provide ideas and methods for the research of disease assessment models in related fields.

Accurate assessment of the condition is the prerequisite and basis for standardized clinical treatment. Traditional Chinese medicine has shown good efficacy and advantages in treating AECOPD, but currently there is no ideal standard for judging the severity, nor is there an accurate, practical, and TCM specific disease assessment tool. Therefore, this project integrates multidimensional variables of traditional Chinese and Western medicine, and intends to conduct research on the construction of a disease syndrome combined AECOPD disease assessment model through literature review, expert consultation, clinical investigation, and machine learning algorithms, and establish preliminary grading standards for the severity of AECOPD disease. Ultimately, it provides ideas and methods for the rapid and accurate assessment of AECOPD, standardized diagnosis and treatment, improved efficacy, improved prognosis, and research on disease assessment models in related fields.

Eligibility Criteria:
Inclusion Criteria:

* Meets AECOPD diagnostic criteria.
* Voluntarily participate in the research and sign the consent form

Exclusion Criteria:

* Individuals with severe mental disorders and cognitive impairments who are unable to communicate normally
Remimazolam and Propofol on the Left Ventricular Strain During Anesthesia Induction for Non-cardiac Surgery

This study to compare the impacts of remimazolam or propofol on the left ventricular global longitudinal strain (LV-GLS) during anesthesia induction for non-cardiac surgery.

LV-GLS is analyzed by using speckle tracking technique of transthoracic echocardiography.

This study to compare the impacts of remimazolam or propofol on the left ventricular global longitudinal strain (LV-GLS) during anesthesia induction for non-cardiac surgery (n=40).

Remimazolam or propofol is randomly administered for anesthesia induction (Group-R and Group-P, respectively) The changes of LV-GLS are analyzed by using using speckle tracking technique. For this study, 2-dimensional of transthoracic echocardiography LV images (apical 2-chamber, 3-chamber, and 4-chamber views) are recorded and stored before administration of remimazolam/propofol (T0), 2 minutes after the administration (T2), 4 minutes after the administration (T4), and 6 minutes after the administration (T6).

After the completion of the study, LV-GLS values at T0, T2, T4 and T6 are determined by the off-line analyses of the recorded and stored 2D-images.

For the off-line determination of LV-GLS, an automated software of speckle-tracking technique (Qapp Autostrain-LV™, Philips) is employed.

The primary measure:

Inter-group comparison of the lowest LV-GLS value out of LV-GLS values at T2, T4, and T6.

The secondary measures:

Inter-group comparisons of the LV-GLS values at T0, T2, T4 and T8. Intra-group comparisons of the LV-GLS value at T0 vs. those at T2, T4 and T8

Eligibility Criteria:
Inclusion Criteria:

* left ventricular ejection fraction\> 50%
* no left ventricular regional wall motion abnormality

Exclusion Criteria:

* atrial fibrillation
* unfavorable airway
* hypotension requiring inotropic support
A Pragmatic Trial of the Effect of a Mailed Patient Flyer About Prostate Specific Antigen (PSA) Testing Prior to an Annual Exam

1. Does a one-page American College of Physicians educational flyer about the pros and cons of prostate cancer screening sent to men within two weeks of their scheduled annual health examinations in a general medicine clinic result in a different rate of prostate cancer screening than among men who were not sent the flyer?
2. Do patients find the flyer useful and understandable?

Context: The use of prostate specific antigen (PSA) screening for prostate cancer is controversial because of a lack of evidence that such screening saves lives when applied within a population and because such testing can lead to invasive downstream biopsies and aggressive treatment that is associated with a high risk of permanent side effects (e.g. impotence, incontinence). Almost all professional societies (American Cancer Society, American Urologic Association, American College of Physicians, United States Preventive Services Task Force) advocate that patients receive education and complete an informed decision-making discussion with their medical providers about the pros and cons of the PSA test, as well as their personal preferences, before proceeding with this test. Unfortunately, despite these recommendations, there is seldom sufficient time during clinic visits to achieve this goal.


Eligibility Criteria:
Inclusion Criteria:

* Men age 50-74 who were cared for in a general internal medicine clinic
* had scheduled an annual health exam
* had not had a PSA test within the previous year

Exclusion Criteria:

* active cancer diagnosis
* history of prostate cancer
* need for PSA surveillance
Standardized Fecal Microbiota Transplantation for Ulcerative Colitis

The gut microbiota is considered to constitute a "microbial organ" which has pivotal roles in the intestinal diseases and body's metabolism. Evidence from animal and human studies strongly supports the link between intestinal bacteria and inflammatory bowel diseases (IBD). Dozens of studies reported its efficacy in treatment of severe Clostridium difficile colitis. Preliminary studies using FMT for Ulcerative Colitis (UC), Crohn's diseases, irritable bowel syndrome (IBS) and constipation have also met with some success. This is an initial step into investigating the potential efficacy of standardized fecal bacteriotherapy through mid-gut (at least below duodenal papilla) for UC, the investigators propose to determine the efficiency and safety of FMT in a series of 500 patients with moderate to severe UC (Montreal classification).

The present clinical trial aims to re-establish a gut functionality state of intestinal microbiota through FMT as a therapy for UC. Investigators established a standard bacteria isolation from donated fresh stool in lab. Then the bacteria is transplanted to mid-gut through regular gastroscope. Patients in this study will assigned to receive FMT(s) or traditional treatments according to associated guidelines and follow-up for long term. All data were recorded in China Microbiota Transplantation System.

Eligibility Criteria:
Inclusion Criteria:

Patients who had been diagnosed with UC through a combination of typical clinical symptoms, endoscopy, and histological criteria for at least 3 months, and patients who failed to achieve satisfactory efficacy for UC from the previous therapies.

Exclusion Criteria:

Patients were excluded if accompanied by other severe diseases, including other intestinal diseases (e.g., Clostridioides difficile infection), malignant neoplasm, cardiopulmonary failure, and serious liver and kidney disease, refused to complete the follow-up, and underwent FMT or WMT before.
Evaluation of The Effect of Live Probiotic Cultures Present in Fermented Dairy Product (Yogurt) Versus The Effect of Freeze-Dried Probiotic Sachets on Gingival Bleeding of Adolescents

To evaluate the effect of probiotics supplied in two different forms (dairy products containing probiotics as yogurt and freeze-dried synthetic probiotics sachets) on improving gingival condition and caries potentiality of dental plaque in adolescents


Eligibility Criteria:
Inclusion Criteria:

1. Children aged 12-15 years old
2. Children complaining from gingival problems
3. Medically free children
4. Children not registered in other clinical researches

Exclusion Criteria:

1. Children with systemic diseases, mental disorders, chronic debilitating diseases.
2. Children using antibiotic treatment during the study
3. Children with orthodontic treatment
4. Children using antimicrobial mouthwash
5. Children taking any probiotic supplemental therapy
Financial Navigation Program Intervention in Supporting Patients With Solid Tumors and Their Caregivers

This trial studies how well a financial navigation program intervention works in supporting patients with solid tumors and their caregivers. The financial navigation program intervention is an educational course about cancer treatment cost. This educational course may provide cancer patients and their caregivers with helpful information about dealing with cancer treatment cost.

Participants receive financial navigation program intervention consisting of a financial navigation video, monthly one-one financial counselling session, monthly phone or email consultation with patient navigators for 6 months and complete surveys at baseline, 3, 6, and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* PATIENTS: Any solid tumor diagnosis (any stage)
* PATIENTS: Currently receiving (or completed within 6 months) chemotherapy, radiation, or hormonal therapy for cancer
* PATIENTS: In the treating physician's best estimation, has a life expectancy of 6 months or greater
* PATIENTS: Able to identify a primary caregiver who is involved in helping with the logistics, financial, or emotional aspects of his/her cancer care
* PATIENTS: English-speaking
* CAREGIVERS: Caregiver of a patient who is eligible for to participate in the study
* CAREGIVERS: English-speaking

Exclusion Criteria:

* PATIENTS: Cognitive or other impairment that would interfere with ability to understand and/or respond to questions about personal finances and paying for cancer treatment
* PATIENTS: Hematologic malignancy (e.g. multiple myeloma, lymphoma, leukemia)
* CAREGIVERS: cognitive or other impairment that would interfere with ability to understand and/or respond to questions about patient fiances and paying for cancer treatment
Comparative Evaluation of Pediatric Patient Comfort, Time, and Preference Between Digital Scans and Rubber Base Impressions. Crossover Study Randomized Controlled Trial

The comfort of impression methods and the time they require are important because it is known that children are more stressed in their encounter with the dentist than the elderly, and their chairside times are shorter. The comparison of impression methods in terms of comfort, preference, and time has been studied only in young adults or adult patients. thus this study will assess pediatric patient comfort, time, and preference between digital scans and rubber base impressions.


Eligibility Criteria:
Inclusion Criteria:

* cooperative healthy 6-11 years old child

Exclusion Criteria:

* uncooperative with experience with technique
A Study on a Multidimensional Prediction Model for Rupture Risk of Unruptured Intracranial Aneurysms

This is a registry study on a multidimensional prediction model for rupture risk of unruptured intracranial aneurysms in China.

This subsequent program China Intracranial Aneurysm Project - 2 (CIAP-2) will comprise screening of 500 patients from the UIA cohort (CIAP-1) and focus on hemodynamics factors, high resolution magnetic resonance imaging (HRMRI), genetic factors and biomarkers. Possible risk factors for rupture of UIA, including genetic factors, biomarkers, HRMRI, and hemodynamic will be analyzed. The first project of the China Intracranial Aneurysm Project (CIAP-1: Chaired by the Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University, Xi'an, Shaanxi, China) will establish a prospective cohort of 5000 patients with UIA from 20 centers in China, and collect baseline information for each patient. Multidimensional data will be acquired in follow-up assessments. Statistically significant clinical features in the UIA cohort will also be analyzed and integrated into this model for predicting risk of UIA rupture. After the model has been set up, the resultant evidence-based prediction will be used to provide a preliminary theoretical basis for the treatment of aneurysms at high risk of rupture.

Eligibility Criteria:
Inclusion Criteria:

* At least 1 UIA that is untreated and confirmed by imaging: Computed tomography angiography (CTA), magnetic resonance angiography (MRA) and digital subtraction angiography (DSA). Regardless of the presence of clinical symptoms
* Patient currently has the ability to live independently, and a modified Ranking Score less than or equal to 3 points
* Older than 14 years of age
* Patient or relatives agreed to sign the consent form

Exclusion Criteria:

* Subarachnoid hemorrhage of unknown origin
* Presence of other intracranial vascular malformations, such as cerebral arteriovenous malformation (AVM) or cerebral arteriovenous fistula (AVF)
* Intracranial and other malignant tumors
* Fusiform, traumatic, bacterial or dissecting aneurysm
* Patients with severe mental illness who are unable to communicate
* Patients with other diseases or poor general condition who are expected to survive less than 1 year
* Patients with intracranial aneurysms who have joined other similar research institutions
* Patients who refused follow-up

The definition of modified Ranking Score:

* 0 Completely silent
* 1 Despite symptoms, but not visibly disabled, can complete all regular duties and activities
* 2 Mild disabilities, not all activities previously possible, but can deal with personal affairs without need of assistance
* 3 Moderate disability requires some help, but walking does not need assistance;
* 4 Severe disabilities, unable to walk independently, no others can not meet their needs
* 5 Severely disabled, bedridden, Urine, requiring continuous care and care;
* 6 Mortality
veRy Thin Stents for Patients With Left mAIn or bifurcatioN in Real Life: the RAIN a Multicenter Study

For permanent coronary stents, reduction of thickness of struts have become one of the most important innovation, being related to easier manipulation, reduced risk of stent thrombosis and low rate of revascularization. Consequently the investigators performed a multicenter registry enrolling all consecutive patients treated with very thin stents for ULM or bifurcation.

For permanent coronary stents, reduction of thickness of struts have become one of the most important innovation, being related to easier manipulation, reduced risk of stent thrombosis and low rate of revascularization. Previous studies do not have enough power to detect potential significant difference for ULM or bifurcation lesions. Consequently the investigators performed a multicenter registry enrolling all consecutive patients treated with Biomatrix Flex, Xience Alpine, Ultimaster, Resolute Onyx and Synergy. MACE (a composite end point of death, myocardial infarction, target lesion revascularization and stent thrombosis) will be the primary end point, while its single components will be the secondary ones.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing PCI on unprotected left main or coronary bifurcation

Exclusion Criteria:

* PCI performed on other coronary vessels
The Research of Metabolomics on COPD

Targeted metabolomics research was conducted on patients with chronic obstructive pulmonary disease (COPD). The correlation analyst between inflammation-related metabolites and lung function was analyzed by explored the metabolic pathways of inflammation-related omega-6 and omega-3 and combining them with lung function.

Based on the global initiative for chronic obstructive pulmonary disease, the 80 confirmed stable COPD patients with mild-to-moderate were involved, 80 COPD patients with severe and very severe, and age, sex, all matching 40 cases without lung disease. The participants information was collected. Whole blood and pulmonary function were examined at three time points: admission, six months and one year, at the same time, targeted metabolomic analysis method are applied to detect serum metabolites, According to the access to assess the different severity of COPD in the stable period and the level of metabolites in different admission periods. After that, correlation analysis was conducted with pulmonary function indicators and other clinical indicators to observe the research value of inflammation-related metabolites in the development of COPD.

Eligibility Criteria:
Inclusion Criteria:

* COPD diagnosis
* The age ranges from 40 to 80
* No other pulmonary diseases
* No immune-related diseases

Exclusion Criteria:

* Not consistent with COPD diagnosis
* Age is out of range
* Interstitial lung disease, asthma and other lung diseases
* Immune system diseases
* Lost to follow-up