cyrilzakka/clinical-trials huggingface dataset:
Crossover Study From Macitentan or Bosentan Over to Ambrisentan

The purpose of this study is to learn more about the safety and effects of switching treatments from bosentan (Tracleer) or macientan (Opsumit) to ambrisentan (Letairis) over 24 weeks in subjects with Connective Tissue Disease associated Pulmonary Arterial Hypertension (CTD-PAH).

The study will consist of a group of subjects who have been on bosentan for at least three months and a group that has been on macitentan for at least three months. Both groups will be switched to Letairis 5mg daily after the bosentan or macitentan therapy for three months and then increased to a dose of Letairis 10mg daily at week 4 if well tolerated.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of a Connective Tissue Disease (CTD)
* Age range: 18-80 years old
* Previous Right Heart Catheterization (RHC) demonstrating PAH
* Forced vital capacity (FVC) greater than 50%
* Carbon Monoxide Diffusing Capacity (DLCO) greater than 50%
* World Health Organization (WHO) functional class II or III
* Able to perform a 6 minute walk test (6MWT)
* Stable dose of antihypertensive medications
* Non-pregnant females
* Have to be currently on stable dose of bosentan for at least 3 months
* Adequate acoustic images to allow for transthoracic echocardiography to be performed

Exclusion Criteria:

* Exercise limitation related to a non-cardiopulmonary reason (e.g. arthritis)
* Severe systemic hypertension greater than 170/95
* Patients with a prior history of cardiovascular disease
* WHO functional class IV status
* Patients with severe other organ disease felt by investigators to impact on survival during the course of the study.
* FVC less than 50% of predicted
* DLCO less than 50% of predicted
A Comparison Between Bandage Contact Lens, Punctal Plugs and Standard Measures in Preventing Corneal Injuries

Study Rationale:

The insertion of a bandage contact lens or punctal plug in a defined group of patients admitted to the ICU may be more effective than standard care in decreasing the incidence of corneal injuries.

Study Objectives:

1. To document the effect of a contact bandage lens and punctal plug in preventing corneal injuries in critically ill patients admitted to the ICU.
2. To assess the safety of a contact bandage lens and punctal plug in critically ill patients.

This is a prospective, randomized study

Study Population:

Consecutive patients admitted to the General Intensive Care Unit of the Rabin Medical Center and Sharon Hospital Medical Center over a 6-month period who meet criteria for inclusion.

Procedures:

Consecutive patients meeting inclusion criteria will be enrolled in the study. Patients will be randomized to 3 groups: the bandage contact lens group, who will be assigned to insertion of a bandage contact lens; the punctal plug group, who will be assigned to the insertion of punctal plugs; and the control group, who will be assigned to standard eye care as currently practiced in the ICU.

In addition, patients in the study will be examined every 4 days by a physician from the ophthalmology department and at either discharge from the ICU or at time of death.

Eligibility Criteria:
Inclusion Criteria:

- Patients must be \> 18 years of age. Patients who meet the following criteria will be considered eligible for the study: i) require mechanical ventilation; ii) require continuous infusion of sedative medication with or without neuromuscular paralysis; iii) anticipated ICU stay \> 5 days.

Exclusion Criteria:

- Patients will be excluded if there is any preexisting corneal disease or an ophthalmic injury related to the present admission (e.g. ophthalmic trauma) to the ICU.
Conduction System Pacing vs Biventricular Resynchronization Therapy in Systolic Dysfunction and Wide QRS: CONSYST-CRT.

Conduction system pacing vs biventricular resynchronization therapy in systolic dysfunction and wide QRS (CONSYST-CRT randomized clinical trial) is a non-inferiority trial that aims to study the composite endpoint consisting of all-cause mortality, cardiac transplant, heart failure hospitalizations, and left ventricular ejection fraction (LVEF) improvement \<5 points.

To date, studies have shown that conduction system pacing could get similar clinical and echocardiographic responses to those obtained with biventricular therapy.

This study will randomize 130 patients to a strategy of biventricular pacing versus conduction system pacing.

CONSYST-CRT study will analyze the following parameters in the 2 groups: left ventricular ejection fraction, ventricular volumes, echocardiographic response (\>=15% decrease in left ventricular end-systolic volume), NYHA functional class, heart failure hospitalization, all-cause mortality, cardiac transplant, QRS shortening, echocardiographic asynchrony (septal flash).

Clinical, electrocardiographic, echocardiographic follow-up will be performed for 1 year.

The first 70 patients have been recruited in the context of the LEVELAT study (ClinicalTrials.gov Identifier: NCT04054895)

Eligibility Criteria:
Inclusion Criteria:

* The patient must indicate their acceptance to participate in the study by signing an informed consent document.
* The patient must be ≥ 18 years of age.
* Left bundle branch block, QRS ≥130 and LVEF \<=35%. No indication of stimulation for AV block.
* Non-left bundle branch block, QRS ≥150 and LVEF \<=35%.
* Patients with indication of resynchronization therapy for ventricular dysfunction (LVEF \<40%) and indication of cardiac pacing for AV block.
* LVEF \<=35% in NYHA class III or IV if they are in atrial fibrillation and have intrinsic QRS \>=130 ms, provided a strategy to ensure biventricular capture is in place.

Exclusion Criteria:

* Myocardial infarction, unstable angina or cardiac revascularization during the previous 3 months.
* Pregnancy.
* Participating currently in a clinical investigation that includes an active treatment.
Fluoride Application on Preventing and Arresting Root Caries in Fluoridated and Non-fluoridated Areas

This study was a randomized clinical trial lasting for 24 months in two study sites, Hong Kong (water fluoridated) and Guangzhou (non-fluoridated area). A total of 534 subjects will be recruited from elderly social centers located in different districts in the two study sites (260 \& 274). Baseline clinical examination was conducted by a single calibrated examiner in the social centers using an intra-oral LED light, mouth mirrors and probes. Subjects were randomly allocated into two study groups and receive interventions accordingly. Follow-up examinations at 6-month intervals were carried out to assess the clinical outcomes, i.e. whether new root caries developed and whether the active root caries found at baseline become arrested. Results of this study could provide the much needed evidence to guide the dental professionals in Hong Kong and China, and possibly worldwide in deciding on the most appropriate intervention for the prevention and management of this common dental disease of the older adults.

The primary and secondary outcome of this study was new root caries and arrested root caries. A root surface with new caries experience was recorded when a root surface which was sound at baseline was found to have a carious lesion or a filling at a follow-up examination. Arrested root caries was recorded when the active root caries found at baseline changed into inactive root caries at follow-up. The status of each root surface was recorded using the codes recommended by the International Caries Detection and Assessment System (ICDAS Ⅱ) Coordinating Committee in 2009.

A mean root caries increment of around 0.8 root surface per year of control group was reported in a previous clinical trial conducted in Hong Kong. Thus, in this study, a 24-month increment of 1.6 new decayed root surfaces and a standard deviation of 2 was anticipated. In order to show that a 50% difference in mean caries increment between the test and control groups was statistically significant using a 2-sample t-test at a 5% significance level and at an 80% power, a sample size of 100 subjects in each group was required. Allowing for a drop-out rate of 20% over 24 months, a total of 480 subjects (120 in each group each site) were needed.

Eligibility Criteria:
Inclusion Criteria:

1. have at least 5 teeth with exposed root surfaces and not indicated for extraction, and
2. living in the community and have self-care ability for normal daily activities.

Exclusion Criteria:

1. have life-threatening or serious health problems,
2. have cognitive problems in communication or in receiving oral hygiene instructions
3. have salivary gland diseases or received radiotherapy in the head and neck region.
Safety and Efficacy of Sofosbuvir-Based Regimens in the Treatment of Egyptian Patients With Hepatitis C Infection

Egypt has the highest prevalence of hepatitis C virus (HCV) in the world, estimated nationally at 14.7%. Genotype 4 (and subtype 4a in particular) dominates the HCV epidemic in Egypt. For decades the antiviral therapy of chronic HCV infection was based on the administration of Interferon(IFN), initially alone and then in combination with Ribavirin (RBV), but this regimen was effective in only 50% of patients with genotype 1, with significant side effects.

Egypt has the highest prevalence of hepatitis C virus (HCV) in the world, estimated nationally at 14.7%. Genotype 4 (and subtype 4a in particular) dominates the HCV epidemic in Egypt. For decades the antiviral therapy of chronic HCV infection was based on the administration ofInterferon(IFN), initially alone and then in combination with Ribavirin (RBV), but this regimen was effective in only 50% of patients with genotype 1, with significant side effects. The introduction of direct acting antiviral agents, in particular sofosbuvir (SOF), has revolutionized the treatment for chronic hepatitis C virus.

Eligibility Criteria:
Inclusion Criteria:

* • HCV infection

  * Adult patients, 18years and older.

Exclusion Criteria:

* • Child score \> 12

  * Severe Renal impairment
  * Pregnant and lactating women
  * HCC or other malignant neoplasms
  * Co-infection with human immunodeficiency virus (HIV)
  * Co-infection with hepatitis B virus (HBV)
Preoperative Intratumor Dendritic Cells Injection Immunotherapy for Patients With Pancreatic Cancer

The purpose of this study is to confirm safety and immunological responses of Preoperative intratumor dendritic cells injection immunotherapy using immature dendritic cells with S pyogenes Preparation (OK-432) for patients with resectable pancreatic cancer for pancreatic cancer patients.

The prognosis of pancreatic cancer is extremely poor even with extensive surgery, and development of new treatment modalities is much-expected for cure of this disease. Dendritic cells (DCs) immunotherapy is expected favorable outcome when it is approached directly to the cancer tissue. To evaluate safety and immunological responses, we conducted a phase I/II study of intra-tumor DCs immunotherapy for pancreatic cancer patients.

Eligibility Criteria:
Inclusion Criteria:

Resectable pancreatic cancer without distant metastasis:

1. ECOG performance status 0-2
2. Laboratory values as follows 3,500/mm3 \<WBC\<12000/mm3 Platelet count\>100,000/mm3 T-Bil\<2.0mg/dl BUN\<25mg/dl, Creatinin\<1.5mg/dl, 24h Ccr\>50ml/min Normal ECG
3. Able and willing to give valid written informed consent

Exclusion Criteria:

1. Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
2. Breast-feeder
3. Active or uncontrolled infection
4. Active or uncontrolled other malignancy
5. Steroids or immunosuppressing agent dependant status
6. Interstitial pneumonia
7. Decision of unsuitableness by principal investigator or physician-in-charge
A Study to Evaluate the Drug Levels of BMS-986165 When Taken as Various Solid Tablet Prototypes by Healthy Participants

The purpose of this study is to evaluate the drug levels of BMS-986165 in when taken by mouth as various solid tablet prototypes, by healthy participants.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* No clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations.
* Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive, and total body weight ≥50 kg (110 lb). BMI = weight (kg)/(height \[m\])2 at screening.
* Willing and able to consume 4 units of alcohol (Part B only)
* A negative polymerase chain reaction (PCR) test for coronavirus disease 2019 (COVID-19) at screening and admission
* Males and females must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

* Current or recent (within 3 months or 90 days of study drug administration) clinically significant gastrointestinal disease that, in the opinion of the investigator or medical monitor, could impact upon the absorption of study drug
* Any medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of or active liver disease.
* Clinically significant history or presence of acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicemia) within the 3 months or 90 days prior to screening.

Other protocol-defined inclusion/exclusion criteria apply
Dräger COVID-19 Antigen Test Clinical Performance Study

The study is designed to demonstrate suitability of the Dräger Antigen Test for SARS-CoV-2 detection in clinical nasal specimens. Real-time polymerase chain reaction (RT-PCR) on specimens collected by pharyngeal swabs serves as a reference method.

The Dräger Antigen Test SARS-CoV-2 is a rapid lateral flow immunoassay for the qualitative detection of SARS-CoV-2 nucleoprotein directly from less invasive nasal swabs, to be performed at the point of care. The test kit contains all components required to carry out a test detecting SARS-CoV-2 nucleoprotein.

The study is designed to demonstrate suitability of the Dräger Antigen Test for SARS-CoV-2 detection in clinical nasal specimens. Real-time polymerase chain reaction (RT-PCR) on specimens collected by pharyngeal swabs serves as a reference method.

The goal of the study is to compare Dräger test results to the corresponding PCR data for overall sensitivity and specificity. Specimens are collected from patients showing COVID-19 symptoms as well as asymptomatic participants. Participants are recruited across all genders and eligible age groups. Study staff records participants' information such as symptoms and time since symptom onset. For each study participant, the specimen for RT-PCR is collected first, then the Dräger test specimen. The Dräger test result is read after 15 min to 20 min.

Eligibility Criteria:
Inclusion Criteria:

* Participants must require SARS-CoV-2 testing for the following reasons:

  * COVID-19 symptoms (Fever, cough and/or sore throat, fatigue/ general feeling of weakness, loss of sense of smell and/or taste, shortness of breath, muscle stiffness/ body aches, head cold/ running nose, etc.) on the day of testing, or
  * Known or suspected exposure to SARS-CoV-2 (contact persons etc.), or
  * Member of a group of high risk of exposure such as healthcare workers etc., or
  * Require screening for any other reason, e.g. doctor's orders, hygiene directive etc.
* Participant must be of legal age and must be able to understand the procedure and letter of consent.

Exclusion Criteria:

* Patients younger than 18 years old are excluded from the study.
* Pregnant or breastfeeding patients are excluded from the study.
* Patients unable to provide written informed consent are excluded.
* Patients with bleeding disorder are excluded from the study as a precaution.
* Hospitalized patients/inpatients are excluded.
* Application of nasal spray within 15 min prior to testing.
* Participants with symptoms on the day of testing are excluded, if any of their symptoms started more than 14 days prior to testing.
* Asymptomatic participants are excluded, if they experienced any symptoms in the 14 days prior to testing.
The Mechanism and Prognosis of Pulmonary Circulation Dysfunction

Venous thromboembolism (VTE) is a condition which influenced by both environmental and genetic factors. This study is going to explore new significant Single nucleotide polymorphisms (SNPs) associated with VTE by Genome-Wide Association Studies (GWAS) and bioinformatics analysis. Transcriptomics and cytokine antibody array are also used to find new biomarkers of VTE's early diagnosis, severity and prognosis.


Eligibility Criteria:
Inclusion Criteria:

* Chinese Han population older than 14 years old
* Acute VTE patients diagnosed in 1 month
* With informed consent

Exclusion Criteria:

* Patients with psychosis
* Patients with contraindications for computed tomographic pulmonary angiography (CTPA)
* Chronic VTE
* Recurrence of chronic VTE
The Efficacy of Oregano Essential Oil in Reducing Oral Halitosis

the efficacy of commercially available oregano essential oil mouthwash in the reduction of oral halitosis was compared to chlorhexidine and distilled water and the results showed significant reduction of organoleptic tongue and floss scores and BANA test scores compared to placebo

the results showed that oregawash showed a comparable effect to chx in reducing oral halitosis

Eligibility Criteria:
Inclusion Criteria:

1. Organoleptic score was \>2 at baseline.
2. Participants between 18-23 years of age.
3. The subjects had no systemic disease and were not taking antibiotics or receiving other antimicrobial therapy.
4. The subjects did not receive the same time treatment for their halitosis.

Exclusion Criteria:

1. Smokers, alcoholics and drug addicts.
2. Patients with periodontitis or pocket depth \>6 mm.
3. Patients taking drugs which induced xerostomia.
4. Subjects consuming spicy food: garlic or onions two days before examination.
5. Patients with orthodontic appliances or removable dentures.
6. pregnancy
Feasibility Study: Evaluate the Effectiveness of Using a Topical Anesthetic Prior to Ultherapy™ Treatment

This study will evaluate the efficacy of a lidocaine topical anesthetic (numbing cream) for reducing discomfort associated with Ultherapy™ treatment.

All subjects will receive a full face and neck Ultherapy™ treatment. Thirty (30) minutes prior to treatment, a topical anesthetic (numbing cream) will be applied to one side of the face and neck and a placebo cream with similar consistency and color will be applied to the other side of the face and neck, in a randomized fashion. The subject and investigator or sub-investigator performing Ultherapy™ treatment will be blinded to the side to which the topical anesthetic is applied. Pain scores will be collected following treatment of each section of the face and neck on both sides. Subjects will return for a 90-day post-treatment visit to assess improvement in skin laxity, and overall lifting and tightening of skin.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 30 to 65 years.
* Chosen an Ultherapy™ treatment as part of their treatment regimen.
* Subject in good health.
* Skin laxity on the face and neck.
* Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the followup period.
* Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study

Exclusion Criteria:

* Known sensitivity to lidocaine or any other anesthetic of the amide type.
* History of anaphylactic shock.
* Presence of an active systemic or local skin disease that may affect wound healing.
* Current therapy with class I antiarrhythmic drugs (e.g., tocainide, mexiletine).
* Known or suspected hypersensitivity to LMX-4 active substance, or any of the amide-type local anaesthetics, or any of the excipients (protocol section 10.3).
* Severe solar elastosis.
* Excessive subcutaneous fat in the face and neck.
* Body mass index of 30 or greater.
* Excessive skin laxity on the face and neck.
* Significant scarring in areas to be treated.
* Significant open facial wounds or lesions.
* Severe or cystic acne on the face.
* Presence of a metal stent or implant in the facial area to be treated.
Post-treatment Surveillance in HPV+ Oropharyngeal SCC

In this research study the investigators are examining a blood test to detect HPV DNA in the blood that can possibly detect cancer recurrence earlier than with standard surveillance measures.

This research study involves blood tests to detect HPV DNA at regular time points after treatment for HPV-positive oropharyngeal squamous cell carcinoma (HPV-OPC). Participants may undergo scans based on the results of the blood tests. Study participants will also be asked to complete quality of life questionnaires periodically.

Participation in this study may last for up to 3 years. It is expected that about 150 people will take part in this research study.

Eligibility Criteria:
Inclusion Criteria:

* Participants must have histologically or cytologically confirmed incident or recurrent squamous cell carcinoma of the tonsil or base of tongue (oropharynx) - includes biopsy of any lymph node with clinical evidence of an oropharynx tumor (unknown primary carcinoma in an involved cervical neck lymph node is permitted if high-risk HPV testing is positive on the involved node)
* HPV-associated tumor as defined by one or more : positive p16 immunohistochemistry (\>70%) OR in situ hybridization OR PCR-based methods
* Age 18 years or older
* Will undergo oropharyngeal cancer treatment with curative intent
* Ability to understand and the willingness to sign a written informed consent document.
* Baseline positive or detectable ctHPV DNA result in plasma OR detectable corresponding HPV DNA in tumor tissue prior to treatment

Exclusion Criteria:

* Distant metastatic disease (M1, AJCC 8th edition)
Implementation of the S'TIM Serious-Game for Rehabilitation of Dysexecutive Disorders (S'TIM)

This study proposes to improve the management of dysexecutive syndrome by a serious game (SG) in addition to the usual management including work in occupational therapy and neuropsychology.


Eligibility Criteria:
Inclusion Criteria:

* French-speaking male or female patient at least 18 years old
* Patient suffering from recent disorders (less than 6 months) of executive functions
* Patient with sufficient mobility of the upper limb (mobility of the dominant upper limb greater than 70 °) to interact with the device.
* Patient affiliated or beneficiary of a social security scheme
* Patient having signed the free and informed consent.

Exclusion Criteria:

* Patient participating in another clinical study
* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision,
* Pregnant or breastfeeding woman,
* Patient hospitalized without consent.
* Patient with unstable psychiatric disorders
* Patient with comprehension disorders (alexia, visual agnosia, illiteracy, not understanding the language, etc.)
* Patient with executive function disorders greater than 6 months
* Negligent hemi patient
* Patient not familiar with the French language
* Patient with major neuro-visual disorders.