cyrilzakka/clinical-trials huggingface dataset:
Is High Sensibility Troponins a Dialysable Marker in Hemodialysis Patients and Does it Have Prognostic Value?

Evaluation of High sensibility troponin levels modification by hemodialysis in terminal renal failure patient at Sherbrooke University Hospital Center as determined by serial measurements. Verification of potential effects of these levels and their variation as predictors of cardiovascular outcomes and events at 6 and 12 months.

Recruiting of hemodialysis patients of the nephrology renal supplementation clinics at Sherbrooke University Hospital Center to measure three blood level of high-sensibility troponins before and after standard dialysis. Verification on the variation of these levels after dialysis. Follow-up at 6 and 12 months of the patient for Cardiovascular events and death and verification of a possible predictive value of troponin blood levels for these events.

Eligibility Criteria:
Inclusion Criteria:

* over 50 years, no symptoms, over 1 months of hemodialysis

Exclusion Criteria:

* 1 or more in the last month; Acute coronary syndrome, Heart failure decompensated, Myo or Pericarditis, Pulmonary embolism, Sepsis/shock, Stroke or transient ischemic attack, Malignant high blood pressure, Arrythmia, electrical cardio-version, major trauma, significant burnings (\>25%), Chemotherapy, Cardiovascular surgery, percutaneous angio-intervention,
* Chronic systemic disease (sarcoidosis, amyloidosis, LED, Etc.)
Yoga Breath Program and Client-Centered Exposure for Relief of PTSD in Tsunami Victims

Study hypothesis: that a standardized course of Eastern practices (Breath Water Sound Course -BWS) will significantly relieve PTSD and depression in tsunami victims. Further, that a client-centered exposure treatment (Traumatic Incident Reduction- TIR) would provide additional, significant relief of PTSD and depression in tsunami victims.

180 tsunami victims in Southern India will be divided into three groups: those that only receive BWS course, those that receive the BWS course and TIR and a wait-list control. They will be pretested with the PCL-17 (PTSD scale), the Beck Depression Inventory and the General Health Questionaire. These scales will also be administered post-service as well as five weeks post pre-testing and at three and six month intervals.


Eligibility Criteria:
Inclusion Criteria:

1. Tsunami witness, tsunami victim, and/or lost loved one or property.
2. Ages 18-70
3. Willing to participate for the entire length of this research study.

Exclusion Criteria:

1. Drug addiction, notwithstanding alcohol or tobacco.
2. Schizophrenia or other severe pre-existing mental illness
3. Severe physical disability or illness that would prevent study completion.
Metoclopramide for Gastric Visualization in Active Upper GI Bleeding

This study aim to evaluate the efficacy of metoclopramide for gastric visualization in patients with active UGIB. This is a double-blinded, multicenter RCT. Patients with 'active' UGIB (hematemesis or presence of fresh blood in the nasogastric tube) were enrolled. The eligible patients were randomly assigned in a concealed 1:1 allocation to received either intravenous metoclopramide or placebo before endoscopy. The primary outcome was 'adequate visualization' by objective endoscopic visualized scores(EVS). Secondary outcomes included mean difference in total EVS and EVS at each location , duration of EGD, immediate hemostasis, need for a second look EGD, units of blood transfusion, length of hospital stay and 30-day rebleeding rate.

* This is double-blinded, multicenter RCT including six hospitals in Thailand.
* The participated endoscopists had work experience for endoscopy more than three years.
* All endoscopists at six participating sites attended the pre-study meeting for standardization of the protocol and scoring system.
* The primary outcome was 'adequate visualization' by objective endoscopic visualized scores(EVS). ; To assess overall endoscopic visualization, we estimated the coverage of a blood clot on mucosa in four locations including 1) gastric fundus, 2) corpus, 3) antrum and 4) duodenal bulb, according to the reference endoscopic views in protocal.
* All photos, including the reference endoscopic views, were taken and internally validated by another endoscopist who was blinded to the randomization allocation.
* This study includes pre-specified subgroup analysis by location of bleeding including gastric subgroup analysis.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients (aged ≥ 18years)
* Active UGIB who arrived at emergency room (ER) and had a schedule for EGD within 12 hours after onset of bleeding ; Active UGIB was defined as having hematemesis or fresh blood by diagnostic gastric lavage at the ER.

Exclusion Criteria:

* known allergy to metoclopramide
* prior gastric or duodenal surgery
* known case of esophageal, gastric or duodenal cancer;
* advanced HIV infection (defined as WHO criteria13-15: CD4 \<200 cell/mm3 or WHO clinical stage 3 or 4)
* pregnancy
* gastric lavage was performed with solution \> 50 ml.
Evaluation of Tuberculosis Treatment Outcomes

Tuberculosis (TB) is an infectious disease caused by Mycobacterium species grouped in the Mycobacterium tuberculosis complex. TB remains a major global health problem, despite the fact that there are drugs that can eradicate the infection. The study aims to describe the clinical, microbiological, therapeutic and prognostic characteristics of TB patients afferent to the SC Infectious Diseases of A.O. SS Antonio e Biagio e Cesare Arrigo of Alexandria during 2019-2022 and, secondarily, to evaluate the treatment outcomes (as defined by the World Health Organization) of TB patients afferent to the SC Infectious Diseases of A. O. SS Antonio e Biagio e Cesare Arrigo of Alexandria considering the influence of the SARS-CoV-2 pandemic (pre-pandemic, inter-pandemic and post-pandemic period) and to evaluate the post-treatment relapse rate.

Tuberculosis (TB) is an infectious disease caused by Mycobacterium species grouped in the Mycobacterium tuberculosis complex. TB remains a major global health problem, despite the fact that there are drugs that can eradicate the infection. Of concern, however, are both underdiagnosis and the circulation of strains resistant to first-line therapies. Indeed, if not properly administered, TB treatment regimens are associated with unfavorable outcomes, promoting the circulation of the bacterium and the emergence of drug resistance. Monitoring the effectiveness of tuberculosis treatment is therefore of paramount importance in both clinical practice and surveillance to maximize the quality of individual patient care and the effectiveness of public health actions. The COVID-19 pandemic has created unprecedented challenges for populations, public health departments, and health facilities worldwide, and is likely to have devastating effects on global TB prevention and control programs, including a reversal of the progress achieved over the past decade.The present study aims to describe the case history of TB patients afferent to A.O. SS Antonio e Biagio and Cesare Arrigo in Alexandria and to evaluate treatment outcomes. This facility underwent a disruption of services during the pandemic period, and also initiated in the post-pandemic period a TB clinical management service with an active retention-in-care approach, generating appointments for follow-up visits and contacting patients who did not keep these appointments.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥18 years
* Patients with tuberculosis with microbiological confirmation
* Patients notified to the SS Surveillance and Control Hospital Infections Antimicrobial Stewardship of the Alexandria Hospital Company from 2019 to 2023
* Patients taken in charge by the SC Infectious Diseases of the Alexandria Hospital Company for whom MOD B has been completed
* Obtaining informed consent
A Study of MT-0551 in Patients With Systemic Sclerosis

The study will verify the superiority of MT-0551 to placebo at 26 weeks after treatment initiation in systemic sclerosis (SSc) patients using the modified Rodnan Total Skin thickness Score (mRTSS) as a measure of skin thickening. The safety and pharmacokinetics will also be investigated.


Eligibility Criteria:
Inclusion Criteria:

Additional screening criteria check may apply for qualification:

1. ACR/European League Against Rheumatism (EULAR) criteria (2013) systemic sclerosis (SSc) diagnostic criteria satisfied.
2. Skin thickening score based on the mRTSS between 10 and 22 inclusive.

Exclusion Criteria:

Additional screening criteria check may apply for qualification:

1. Pulmonary hypertension associated with SSc.
2. Presence of a serious, SSc-related concurrent illness other than interstitial pneumonia.
3. Finding of inadequate respiratory reserve capacity.
4. Past history of rituximab, blinatumomab, obinutuzumab, or ofatumumab.
5. Presence of a clinically significant active infection requiring antimicrobial therapy.
6. A past history of cancer.
7. Past history of a recurrent, clinically significant infection.
8. Past history of severe allergy or anaphylactic reaction to a biologic drug product.
9. Treatment with live vaccine within a certain period (inactivated vaccine is acceptable).
A 24 Month Observational Study of Infants 3-24 Months, Who Suffer an Acute Episode of Respiratory Infection and Wheezing Illness

This study will identify infants between the age of 3 and 24 months of age who are experiencing one of their first acute respiratory infections with confirmed wheezing. Infants who are also confirmed to be wheezing and whose caregiver signs consent will be enrolled from a primary care clinic, emergency room or hospital.

BACKGROUND: Respiratory virus infections are extremely common in young children. These infections typically lead to inflammation and constriction of the airways, which is termed bronchiolitis. Bronchiolitis is the leading cause of hospitalization for infants with respiratory infections, with an average of 120,000 children under the age of one hospitalized every year. Viral infection by Respiratory Syncytial Virus (RSV), rhinoviruses, or influenza viruses is thought to be by far the major driver of bronchiolitis. The children who need to be hospitalized with bronchiolitis have a drastically increased chance (about 45%) of developing chronic respiratory diseases such as wheezing or asthma. The disease of asthma affects children more than adults, and the Centers For Disease Control states that asthma is the most chronic condition among children under the age of 18, affecting more than 6 million (or 8.4%) children in the US. Due to this prevalence, asthma is the third leading cause of hospitalization among children under the age of 15 years, with the annual direct healthcare costs at \~$50 billion every year. The economic costs associated with parental lost productivity is another \~$6 billion every year. The American Lung Association states that asthma is also one of the leading causes of school absenteeism, with an estimated 13.8 million lost school days every year. While asthma can be managed with bronchodilator inhalers, there is not a single treatment designed to prevent or reverse asthma disease. Understanding how viral infection causes initial bronchiolitis and maintains the chronic inflammation that leads to asthma will lead to new treatments that prevent or reverse chronic lung diseases. This research has the potential to change everyday life for millions of children and their families in the US.

Eligibility Criteria:
Inclusion Criteria:

* Documented informed consent from legal guardian prior to study procedures
* Age: 3-24 months at the time of visit 1
* Severe lower respiratory wheezing illness confirmed by auscultation requiring hospitalization or acute care (Emergency Department care or unscheduled ambulatory care)

Exclusion Criteria:

* No prior hospital admissions for wheezing illnesses
* No prior diagnosis of asthma or Reactive Airways Disease
* More than 1 prior episode of wheezing confirmed by auscultation
* No congenital or chronic disease which would negatively affect the conduct of the study (e.g. childhood cancer, cystic fibrosis, interstitial lung disease, prior aero-digestive surgery)
* No diagnosis of bronchopulmonary dysplasia
* No premature birth (gestational age \< 32 weeks)
* Daily treatment with a daily asthma controller (e.g. Montelukast, inhaled corticosteroid)
Clinical Performance of Incremental and Bulk Fill Composites in Class II Restorations

This study will examine the clinical performance of Class II restorations over a three year period with 3 composite resins - a conventional composite resin, a flowable composite resin and a bulk placed and cured composite resin.

Specific Aim: To place three commercially available resin composites in Class II cavity preparations of adult patients, evaluate the resin composite restorations at baseline, 6 months, 1 year, 2 and 3 years using specific criteria defined by International Dental Federation (FDI).

Eligibility Criteria:
Inclusion Criteria:

* must have given written informed consent to participate in the trial
* must need at least three posterior dental fillings
* replacement restorations due to caries or an esthetic replacement with or without caries are acceptable.
* must be available for the required post-operative follow-up visits
* restorations must be in contact with opposing natural or crowned teeth with at least at least one occlusal contact in habitual closure
* Class II restorations must have at least one proximal contact
* restorations must have a buccal to lingual/palatal width no greater than 1/3 the distance from buccal to lingual/palatal cusp tips
* all restorations must Class II with a proximal contact with a natural or artificial tooth

Exclusion Criteria:

* have severe medical complications (organ transplants, long term antibiotic or steroid treatment, cancer or immunocompromised) and disabilities who may not be able to tolerate the time required to complete the restorations or to provide adequate oral hygiene
* have xerostomia either by taking medications known to produce xerostomia or those with radiation induced or Sjogren's syndrome patients
* have chronic periodontitis, rampant caries or poor oral hygiene which may require extraction of the teeth to be restored
* are unavailable for long term recall
* cannot tolerate the rubber dam required for isolation of the tooth during preparation and restoration.
* do not meet all inclusion criteria
* present with any systemic or local disorders that contra-indicate the dental procedures included in this study
* have an unstable occlusion
* have severe bruxing or clenching or in need of TMJ related therapy
* have teeth with periapical pathology or expected pulp exposures
* have teeth that are non-vital or that exhibit signs of pulpal pathology
* are pregnant.
A Study of MabThera (Rituximab) Addition to Regularly Prescribed Chemotherapy in Patients With Untreated Mantle Cell Lymphoma.

This multicenter, open-label study will assess the efficacy and safety of MabThera (rituximab) added to standard chemotherapy in participants with untreated Mantle Cell Lymphoma not eligible for autologous stem cell transplantation. Participants will receive MabThera (372 mg/m\^2 intravenously) on Day 1 of each 28-day treatment cycle in addition to standard chemotherapy for 6 cycles. In participants experiencing complete or partial response, MabThera will be continued as consolidation therapy for 2 more cycles.


Eligibility Criteria:
Inclusion Criteria:

* adult participants, \>/=18 years of age
* untreated Mantle Cell Lymphoma, not eligible for Autologous Stem Cell Transplantation
* known mantle cell lymphoma international prognostic index (MIPI) at diagnosis
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* adequate hematological, renal and hepatic function

Exclusion Criteria:

* known hypersensitivity to murine proteins or chemotherapy regimen
* previous first-line therapy
* history of other malignancy within the last 5 years, except for squamous cell carcinoma, basal cell carcinoma of the skin or in situ cervical carcinoma
* active infection
* clinically significant cardiac disease
* regular corticosteroid treatment in the 4 weeks prior to first dose of study drug
Effects of Internet-based Diet Plus Online Dietary Coach Compared With in Person Clinic Visit Approach on Weight Loss

The purpose of this study is to examine the efficacy of an internet based diet plus a regular dedicated dietary coach (ID group) versus clinic visit based weight loss program (CD group) on weight loss in obese and overweight female adults.


Eligibility Criteria:
Inclusion Criteria:

* Must be female
* Must be 18-45 years of age.
* Must have Body mass index (BMI) between 27-35 kg/ m².
* Must be able to have moderate exercise.
* Must be interested to have weight loss.
* Have access to a personal computer and the Internet

Exclusion Criteria:

* Pregnancy or lactation during the previous 6 months, or planned pregnancy in the next six months.
* Taking medications that could affect metabolism or change body weight.
* Report heart problems, chest pain, and cancer within the last five years.
* Smoking
* Menopause
* Diagnosis of any chronic disease such as fatty liver, cancer, chemo/radio therapy, heart disease, immune compromised conditions, abnormal thyroid hormone level.
Study to Evaluate the Efficacy, Safety and Pharmacokinetics of PT001, PT003, and PT005 Following Chronic Dosing (7 Days) in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study is to evaluate, after 1 week of dosing, the efficacy and safety of PT003 compared with its individual components (PT001 and PT005), placebo and two active comparators to demonstrate superiority of the combination to its components, and to assess the relative contribution of the components compared with placebo, in patients with moderate to very severe COPD.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* 40 - 80 years of age
* Clinical history of COPD with airflow limitation that is not fully reversible
* Females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods
* Current/former smokers with at least a 10 pack-year history of cigarette smoking
* A measured post- bronchodilator FEV1/FVC ratio of \< or = 0.70
* A measured post- bronchodilator FEV1 \> or = 750ml or 30% predicted and \< or = 80% of predicted normal values
* Able to change COPD treatment as required by protocol

Exclusion Criteria:

* Women who are pregnant or lactating
* Primary diagnosis of asthma
* Alpha-1 antitrypsin deficiency as the cause of COPD
* Active pulmonary diseases
* Prior lung volume reduction surgery
* Abnormal chest X-ray (or CT scan) not due to the presence of COPD
* Hospitalized due to poorly controlled COPD within 3 months of Screening
* Clinically significant medical conditions that preclude participation in the study (e.g. clinically significant abnormal ECG, uncontrolled hypertension, glaucoma, symptomatic prostatic hypertrophy)
* Cancer that has not been in complete remission for at least 5 years
* Treatment with investigational study drug or participation in another clinical trial or study within the last 30 days or 5 half lives

Other protocol defined inclusion/exclusion criteria may apply
Post-marketing Surveillance of EVRENZO® Tablets (Roxadustat) in Patients With Renal Anemia

The purpose of this study is to assess the safety and efficacy, including the incidence of thromboembolism, in renal anemia patients treated with roxadustat (EVRENZO® Tablets) in actual clinical settings.

This is a post-marketing long-term specified drug use-result survey study required for products in Japan. In the survey, patient registration and data collection will be conducted using post-marketing survey data collection system, PostMaNet via the Internet.

Patients who are eligible for the survey will be registered within 14 days after the start of treatment with roxadustat (including the start day of treatment). For all registered patients (including discontinuations/dropouts), the investigator will enter the necessary information in the case report form (CRF) and send it immediately after the end of the specified observation period for each patient.

Eligibility Criteria:
Inclusion Criteria:

* Renal anemia patients who are naïve to roxadustat.

Exclusion Criteria:

* Not applicable
A Study to Evaluate the Effect of Rifampin on the Pharmacokinetics of Divarasib in Healthy Participants

This is a phase 1, open-label, two-period, fixed sequence drug-drug interaction study to evaluate the impact of multiple doses of rifampin on the pharmacokinetics (PK) and safety of divarasib in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Males or females of non-childbearing potential
* Within body mass index (BMI) range of 18.0 to 32.0 kg/m2, inclusive

Exclusion Criteria:

* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal (GI), neurological, or psychiatric disorder
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator
* Poor peripheral venous access
Role of the Type of Carotid Stent and Cerebral Protection on Cerebral Microembolization During Carotid Artery Stenting. A Randomized Study Comparing Carotid Wallstent vs Roadsaver® Stent and Distal vs Proximal Protection.

Stenting is an alternative to traditional surgery in the treatment of carotid stenosis.The intra and/or postprocedural cerebral embolization remains the most frequent complication.

The type of carotid stent and of cerebral protection are the two most important variables potentially affecting the rate of cerebral microembolization. So far there no consensus on the the best stent and cerebral protection.


Eligibility Criteria:
Inclusion Criteria:

significant, unilateral carotid artery stenosis with soft plaque defined as:

* symptomatic patients: \> 1.3 m/sec peak systolic velocity and \> 50% diameter stenosis by Doppler ultrasound and \< 60 hounsfield unit by CT angiography
* asymptomatic patients \> 2.5 m/sec peak systolic velocity and \> 70% diameter stenosis by Doppler ultrasound and \< 60 hounsfield unit by CT angiography

Exclusion Criteria:

* severe cerebral vasculopathy with cognitive impairment
* contraindication to double antiplatelet treatment
* controlateral carotid occlusion