cyrilzakka/clinical-trials huggingface dataset:
Pembrolizumab Plus Paclitaxel, Cisplatin Followed by Surgery for Locally Advanced ESCC (KEYSTONE-001)

The purpose of this study is to observe and evaluate the efficacy and safety of pembrolizumab plus paclitaxel, cisplatin followed by Da Vinci robot radical surgery for locally advanced esophageal squamous cell carcinoma.

The Preoperative chemoradiotherapy with surgery is the standard treatment in NCCN guideline. But many patients refused or abandon radiotherapy because of the intolerable adverse effects. We designed a single-arm, open-label, phase II trial of pembrolizumab plus paclitaxel, cisplatin followed by Da Vinci robot radical surgery for locally advanced (stage III) esophageal squamous cell cancer. The purpose of this study is to observe and evaluate the efficacy and safety.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed esophageal squamous cell carcinoma;
2. Potentially resectable cT3N1M0，cT1-3N2M0(stage III)(AJCC 8 TNM classification);
3. Have a performance status of 0 or 1 on the ECOG Performance Scale;
4. Age 18-70 years old, both men and women;
5. Be willing and able to provide written informed consent/assent for the trial;
6. Demonstrate adequate organ function , all screening labs should be performed within 10 days of treatment initiation;
7. Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required;
8. Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion through repeated biopsies. Newly-obtained is defined as a specimen obtained up to 4 weeks (28 days) prior to initiation of treatment on Day 1. Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the Sponsor.

Exclusion Criteria:

1. Prior therapy (operation, radiotherapy, immunotherapy, or chemotherapy) for esophageal cancer;
2. Ineligibility or contraindication for esophagectomy;
3. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug;
4. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs);
5. Has severe hypersensitivity and adverse events (≥Grade 3) to nivolumab and/or any PD-1/PD-L1 inhibitors.
Incidence of Bacteremia Following Argon Plasma Coagulation in Patients With Endobronchial Lesions

Incidence of Bacteremia Following Argon Plasma Coagulation in Patients with Endobronchial Lesions

Bacteremia is a well-recognized invasive medical condition. In most cases, it is a transient phenomenon without clinical consequences. In certain patients, such as those with structural cardiac abnormalities, it may lead to the development of infectious endocarditis. According to an American Heart Association statement, routine endocarditis prophylaxis is indicated prior to invasive procedures with relatively high bacteremia rates, such as dental care,certain types of catheterization and rigid bronchoscopy \[1\].Fibreoptic bronchoscopy, with or without biopsy is not included in this list due to a very low bacteremia rate \[1\].This even applies to particularly high risk patients with prosthetic valve or previous endocarditis. Yigla et al. assessed the incidence of bacteremia following bronchoscopy and found 6.5% of bacteremia rate. (2) Recently, Steinfort et al. assessed the bacteremia rate following endobronchial ultrasound and found 7% of bacteremia rate following the procedure. All bacterial isolates were typical oropharyngeal commensal organisms. The transbronchial needle aspiration washing culture was positive in 35% of the patients. However, none of the bacteremic patients had clinical features suggestive of infection and no complications were seen among the cohort. (3) No data are available, however about the bacteremic rate following interventional bronchoscopy for endobronchial obstruction and advance lung carcinoma. In these cases, palliative setting of alleviating central airway obstruction, laser resection, electrocautery, argon plasma coagulation and stenting are techniques that can provide immediate relief.

Argon plasma coagulation (APC) is uses ionize argon gas jet flow to conduct electrons allowing a noncontact mode of treatment (lightning effect). (4, 5) APC has been popular in gastrointestinal endoscopy for superficial coagulation of large mucosal surfaces. The argon gas quite flexibly flows around bends and corners. Coagulated tissue has a higher resistance that automatically drives the argon gas flow away to nearby untreated tissue. An immediate effect really can be seen during electrocautery treatment, which corresponds well with the histological effect of coagulative necrosis.

We therefore conduct a prospective study to assess the bacteremic rate following APC in patients with endobronchial involvement.

Eligibility Criteria:
Inclusion Criteria:

* All patients that undergo bronchoscopy with the use of APC

Exclusion Criteria:

* All patients under 18 years old All Patients with evidence of current respiratory infection or febrile illnesses and those that will receive antibiotic therapy within a week prior to the bronchoscopy
Probiotic and Influenza Vaccination to Reducing Influenza-like Illness Incident in Elderly

To asses the effect of the probiotic and influenza vaccination alone and combination on enhancing immune response to influenza-like illness (ILI) and reducing ILI incidence in the elderly

To see percetange of subjects seroconvertion and seroprotection before and after intervention in the elderly (\>60 years), and monitored for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* all health elderly aged ≥ 60 years
* who came to the vaccination and health education activities in the entire East Jakarta District Health Center
* with Body Mass Index (BMI) 17,5-29,9
* healthy mental status (MMSE score of 28-30)

Exclusion Criteria:

* subject who have contraindications to influenza vaccinations
* are undergoing treatment related to immune system modulation in the past 4 weeks
* therapy for immunossuppresants and/ or corticosteroids eqivalent to prednisone ≥ 20 mg/day that is being lived more than 2 weeks or has only been stopped less than 3 months before the study
* recieved influenza vaccination less than one year before
* Currently consuming probiotic agents, either in the form of a manufacturer or natural for more than 7 days.
The OPTICA Study - The Optimised Computed Tomography Pulmonary Angiography (CTPA) in Pregnancy, Quality and Safety Study

A prospective multicentre study aiming to validate the clinical utility and safety of an optimised low-dose computed-tomography pulmonary angiogram (CTPA) protocol for suspected pulmonary embolism in pregnancy

The OPTICA study is the first prospective study of a low-dose CTPA protocol for the pregnant population. It will define the achievable dose, image quality and safety of this protocol and provide an evidence base upon which modern CTPA protocols can be appropriately compared to scintigraphy for this population.

Pregnant women undergoing the specified low-dose CTPA protocol for suspected pulmonary embolism (PE), agreed across study sites with equivalent computed-tomography (CT) capabilities, will be included. Independent review of CTPAs by two radiology consultants, image data analysis and 3-month patient follow up will be performed.

The diagnostic algorithm employs chest-x-ray and lower limb Doppler if lower limb symptoms are present, followed by CTPA in cases where advanced imaging is required. D-dimer is permitted within the diagnostic algorithm for patients recruited after implementation of the updated 2019 "European Society of Cardiology guidelines for diagnosis and management of acute pulmonary embolism".

Eligibility Criteria:
Inclusion Criteria:

1. Pregnant patients with a suspected pulmonary embolism
2. Age≥18 years

Exclusion Criteria:

1. Age \< 18 years
2. Ultrasound proof of symptomatic proximal deep vein thrombosis
3. Contraindication to helical CT because of allergy to intravenous iodinated contrast or renal insufficiency (creatinine clearance \<30 ml/min)
4. Treatment with full-dose therapeutic low molecular weight heparin or unfractionated heparin initiated 24 h or more prior to eligibility assessment
5. Treatment with vitamin K antagonists (coumarin derivates i.e. warfarin)
6. Unable or unwilling to consent
7. Unable to part-take in follow-up
8. Life expectancy \<3 months
Effects of CPAP in Severe Therapy-resistant Asthma

The purpose of this study is to verify the effects of continuous positive airway pressure (CPAP) on exercise capacity of children and adolescents with severe therapy-resistant asthma (STRA). A randomized, controlled, crossover clinical trial will be conducted. We expect the use of CPAP to increase exercise capacity in children and adolescents with STRA.

This project aims to verify the effects of continuous positive airway pressure (CPAP) on exercise capacity of children and adolescents with severe asthma therapy-resistant (STRA). A randomized, controlled, crossover clinical trial will be conducted. Children and adolescents between 6 and 18 years old, with a diagnosis of STRA, will be included in the study. Patients wil be recruited in the São Lucas Hospital (HSL) Asthma Outpatient Clinic of the Pontifical Catholic University of Rio Grande do Sul. Patients who accept to participate in the study will perform a medical consultation according to routine outpatient asthma clinic, anthropometric evaluation and pulmonary function tests. Afterwards, they will be randomized into control and intervention groups. Participants in the intervention group will use noninvasive ventilation (NIV) in CPAP mode with 10cmH2O of positive end-expiratory pressure (PEEP), fraction of inspired oxygen (FiO2) of 0.21, for a period of 40 minutes. Participants in the control group will use NIV (CPAP), with a minimum PEEP of 1cmH20 and a FiO2 of 0.21 also for 40 minutes. Afterwards, patients from both groups will perform a maximum cardiopulmonary exercise test (CPET). A sample size of 18 individuals to be included in the study was estimated. The variables studied will be maximal oxygen consumption and the anaerobic threshold (that measures exercise capacity), distance and time (to measure exercise tolerance), peripheral oxygen saturation, peak expiratory flow and the sensation of dyspnea at the end of the CPET.

Eligibility Criteria:
Inclusion Criteria:

- Individuals with a clinical diagnosis of severe therapy-resistant asthma (STRA), of both sexes, aged between 6 and 18 years, who are under regular follow-up in the asthma outpatient clinic at São Lucas Hospital, PUCRS.

The criteria for the classification of STRA is based on the Global Initiative for Asthma (GINA) guidelines:

* Asthma requiring treatment in steps 4-5 of GINA (≥800 mg/day of budesonide or equivalent, associated with long-acting ß2-adrenergic agonist (LABA);
* Use of continuous oral corticoid or omalizumab, presenting uncontrolled disease;
* Uncontrolled disease characterized by: 1) persistent symptoms or asthma control test (ACT) \<20 (\> 3 months); 2) acute exacerbations (with intensive care unit admission, at least 2 hospitalizations, or 2 courses of oral corticoid over the last 12 months); Or 3) non-reversible obstruction of pulmonary function, even after corticoid use.

Exclusion Criteria:

- Subjects with cognitive/motor limitations or other chronic diseases (neurological diseases, cardiac anomalies, congenital or immunodeficiencies), which may compromise the evaluation of asthma, as well as the procedures proposed by the present study.
Low-intensity Shockwave Therapy for Post-radical Prostatectomy Erectile Dysfunction

This research study is trying to determine if Low-Intensity shock wave therapy (LiSWT) is safe and effective in patients with symptoms of erectile dysfunction (ED) after radical prostatectomy.

Participants will be randomized to the active treatment group or the control/placebo group.

All patients on active treatment will receive Low-Intensity shock wave treatment. Participants assigned to the control group will receive the treatment using a sham applicator. The placebo group will receive the same treatment as the active group, but the transducer used for shock wave treatment will be capped, meaning that no shock waves will be transmitted to the penis.

Participants on active shock wave treatment will receive once a week Low-Intensity shock wave treatments of 0.2 mJ/ mm² over the lateral penile shaft (distal, mid, and proximal penile shaft), 500 impulses in each area, for a total of 1500 shocks along the penis once a week for six weeks, with a total of 6 treatments once a week.

Eligibility Criteria:
Inclusion Criteria:

1. Men age 45-70 who had robotic prostatectomy within 6 to 18 months
2. Documented nerve sparing during radical prostatectomy procedure
3. Mild to moderate ED after prostatectomy
4. IIEF score \> 18 before surgery
5. Testosterone level \> 300 mg/dl post-surgery
6. Sexually active

Exclusion Criteria:

1. Prior penile surgery
2. Lesions or active infections on the penis or perineum
3. Anatomical abnormalities in the genitalia or pelvic region
4. Unwilling to remove piercing from genital region
5. Post radical prostatectomy complications that could impact safety or effectiveness of ESWT (hematoma, unresolved anastomotic leak)
6. Previous or scheduled treatment with pelvic radiotherapy and/or androgen deprivation therapy
7. Anticoagulant medication (except acetylsalicylic acid up to 80 mg daily).
8. Any other condition that would prevent the patient from completing the study, as judged by the PI
Study of Mycamine® in Children With Fungal Infections to Evaluate Safety and Blood Levels of the Drug

Children with fungal infections will be divided into two groups by weight. Children weighing \< 25 kg will receive a higher dose of study medication (per kg body weight) for 10 to 14 days than children weighing \> 25 kg.

This is a prospective, multicenter, open-label, repeat-dose study conducted in two groups. Subjects in Group 1 and Group 2 will receive treatment for 10 to 14 days (per investigator clinical judgment); dose level (3.0 mg/kg or 4.5 mg/kg) will be determined by the subject's weight at baseline. Study procedures in both groups will be similar except that serial blood samples for assessment of pharmacokinetics will be collected in Group 1. Subjects may only participate in one group of the study.

At least 24 subjects, with at least 8 in each of three age ranges, will be enrolled in Group 1 (PK + safety). At least 36 subjects will be enrolled in Group 2 (safety), with at least 12 in each of the three age ranges.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is 2 to 16 years inclusive
2. Subject has suspected, proven or probable candidiasis, candidemia or other invasive candidiasis
3. Subject has sufficient venous access to permit administration of study medication, collection of pharmacokinetic samples, and monitoring of laboratory safety variables

Exclusion Criteria:

1. Subject has evidence of significant liver disease, as defined by aspartate transaminase (AST), alanine transaminase (ALT), bilirubin or alkaline phosphatase \> 5 times the upper limit of normal (ULN)
2. Subject has a concomitant medical condition that in the opinion of the investigator and/or medical monitor precludes enrollment into the study
3. Subject has a history of anaphylaxis, hypersensitivity, or any serious reaction to the echinocandin class of antifungals
4. Subject has received treatment with an echinocandin within one week prior to first dosing
5. Subject status is unstable and subject is unlikely to complete all study required procedures
Data Collection Study of Wedge Pressure Data in Patients With CRT-D Devices

zWedge is a clinical feasibility IDE study. The objective is to characterize the relationship between intra-thoracic impedance measurements obtained from a CRT-D device and pulmonary capillary wedge pressure (PCWP) measured via a right heart catheterization (RHC) acutely and over time.

Intra-thoracic impedance will be obtained at programmed intervals by using an investigational monitoring feature in the CRT-D device. To obtain impedance values, the device delivers a sub-threshold impulse that measures the resistance between 2 electrodes.

Eligibility Criteria:
Inclusion Criteria:

* Have a SJM PROMOTE CRT-D (Model 3207 or other model with similar functioning) system that was implanted at least 4 months prior to enrollment for an approved indication per ACC/AHA/HRS guidelines.
* Have the ability to provide written informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluation.
* Have legally marketed bipolar right atrial and true bipolar right ventricular pacing defibrillation leads, and a legally marketed endocardial bipolar LV lead.

Exclusion Criteria:

* Be less than 18 years of age.
* Have any medical condition that would interfere with intra-thoracic measurements such as end-stage pulmonary disease, advanced interstitial pulmonary disease, or frequent episodes of pneumonia.
* Have a contraindication for right heart catheterization.
* Have a contraindication for the delivery of IV Nitroglycerin.
* Be pregnant or planning a pregnancy for the duration of their study participation.
* Be currently participating in a clinical investigation that includes an active treatment arm.
* Have a life expectancy of less than 12 months due to any condition.
* Be unable to perform the Valsalva maneuver with airway pressure \> 40 mm Hg for ≥10 seconds.
* Are pacemaker dependent, where cessation of pacemaker function consistently results in syncope or ventricular asystole.
Xylitol Adult Caries Trial (X-ACT)

The purpose of the trial is to determine the extent to which daily use of xylitol lozenges reduces the appearance of new caries lesions in adults who tend to experience such lesions (i.e., caries-active adults).

Dental caries incidence is higher in adults than children. Recent recommendations from both the Centers for Disease Control and an NIH Consensus Development Conference on dental caries call for clinical trials of caries prevention methods in caries-active adults. Little is known about the effectiveness of caries prevention methods in adults, and virtually no information exists with respect to prevention among adults who are at elevated risk for developing caries lesions. This application describes a clinical trial of an intervention to prevent dental caries in caries-active adults that is responsive to the CDC and Consensus Conference recommendations.

The Xylitol for Adult Caries Trial (X-ACT) is a three-year, multi-center, randomized, placebo-controlled, double-blind study to determine the effectiveness of xylitol lozenges in reducing the incidence of coronal and root caries in caries-active adults. The intervention is the daily use of xylitol lozenges. Participants will be 750 adults (ages 25-75) with current or recent caries lesions who are dental school patients at one of three Clinical Centers in Chapel Hill, NC, Birmingham, AL, and San Antonio TX. These Clinical Centers offer diverse populations with substantial proportions of minority populations that enhance the generalizability of the findings. The Study Chair is located at the University of North Carolina-Chapel Hill, and the Data Coordinating Center is at the Kaiser Permanente Center for Health Research in Portland, OR.

This intervention is being tested because it represents a potentially effective caries prevention method with a high likelihood of adoption by dental practitioners as an "add on" caries preventive method for their caries-active patients. The potential for adoption of the intervention is an important consideration because current data suggest that caries-active adults are underexposed to caries-preventive treatment in dental practices. If effective, the intervention also holds potential as a public health measure.

Eligibility Criteria:
Inclusion Criteria:

* age 25-80
* at least one caries lesion in year prior to enrollment
* at least 12 teeth without crowns
* no allergies to xylitol or aspartame
* anticipate remaining in area for 3 years

Exclusion Criteria:

* 10 or more caries lesions in year prior to enrollment
* currently receiving long-term antibiotic therapy
* history of head and neck radiation
Lansoprazole Tablets Special Drug Use Surveillance Gastroesophageal Reflux Disease With Dyspepsia Symptoms

To evaluate the efficacy of 4-week lansoprazole (Takepron) therapy for subjective symptomatic improvement in gastroesophageal reflux disease patients with dyspepsia symptoms

This is a special drug use surveillance of lansoprazole (Takepron) with a 4-week observational period, designed to evaluate the efficacy in gastroesophageal reflux disease patients with dyspepsia symptoms (planned sample size, 15000).

The dosage regimen is as follows:

* For reflux esophagitis, the usual adult dosage is 30 mg of lansoprazole administered orally once daily for up to 8 weeks. For maintenance treatment of repeatedly recurring/relapsing reflux esophagitis, the dosage is 15 mg of lansoprazole administered orally once daily. If insufficient efficacy is observed, the dosage may be increased to 30 mg administered orally once daily.
* For non-erosive gastroesophageal reflux disease, the usual adult dosage is 15 mg of lansoprazole administered orally once daily for up to 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with heartburn or acid regurgitation at the start of Takepron administration\* , or patients without heartburn and acid regurgitation, but with endoscopic findings classified as Los Angeles grade A-D at the start of Takepron therapy.
2. Patients with symptoms of dyspepsia (i.e., postprandial fullness, early satiation, epigastric pain, epigastric burning, upper abdominal bloating, nausea/vomiting, or belching) at the start of Takepron administration\* \*These patients must have answered "never, " "sometimes/mild," "often/moderate," or "frequent/severe" on a 4-point scale questionnaire about subjective symptoms.

Exclusion Criteria:

1. Patients who have taken any proton pump inhibitors (including Takepron) within 4 weeks before the start of Takepron administration
2. Patients taking antidepressants