cyrilzakka/clinical-trials huggingface dataset:
Surveillance Study of Respiratory Syncytial Virus Infection (RSV) in Subjects < 24 Months of Age

The purpose of this study is to collect clinical outcome and nasal viral load information.

There is no vaccine available to prevent Respiratory Syncytial Virus disease; however, a humanized monoclonal antibody is approved for the prevention of Respiratory Syncytial Virus infection in pediatric patients at high risk of disease (eg, pre-term infants, congenital heart disease, and chronic lung disease). Beyond this high-risk group, infection is common in otherwise healthy infants and can be severe, leading to hospitalization and while uncommon, death. Each year in the United States, approximately 100,000 Respiratory Syncytial Virus-related hospitalizations occur in low risk infants. Currently, treatment of infants suffering from Respiratory Syncytial Virus disease is limited to supportive care with the goal of maintaining adequate oxygenation and nutrition.

The availability of a novel anti-Respiratory Syncytial Virus therapeutic that reduces the number of hospitalizations related to Respiratory Syncytial Virus infection would fulfill an unmet medical need in the pediatric population. For maximum effect, such a treatment should be administered as early as possible in the course of infection. Accordingly, the opportunities for early intervention with an anti-Respiratory Syncytial Virus therapeutic are in the outpatient setting, prior to hospitalization. However, the incidence of Respiratory Syncytial Virus-related hospitalization, as well as the natural history and viral dynamics of Respiratory Syncytial Virus infection, remain undefined in the outpatient setting. A better understanding of the prevalence of Respiratory Syncytial Virus infection and subsequent hospitalization rates among symptomatic infants as well as the early disease course of Respiratory Syncytial Virus infection will help in the design of clinical trials needed to assess the efficacy of an anti-Respiratory Syncytial Virus therapeutic developed by Gilead Sciences.

Eligibility Criteria:
Inclusion Criteria:

* \< 24 months of age
* ≥ 35 weeks gestational age at birth
* Signs of acute Respiratory Tract Infection \< 5 days
* Ability to contact parent or legal guardian for follow up

Exclusion Criteria:

* Ongoing Respiratory Tract Infection
* Lung disease
* Heart disease
* Respiratory Syncytial Virus medication in the last 6 months
* Participation in a study with investigational medicinal product in the last 28 days
Safety Study of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Healthy Volunteers Aged Above 3 Months

The purpose of this study is to evaluate safety of meningococcal ACYW135 polysaccharide conjugate vaccine in healthy volunteers aged above 3 Months


Eligibility Criteria:
Inclusion Criteria:

* 3-11 months health infants who haven't immuned with Meningococcal A and C Conjugate Vaccine and population above 1 year old who have't given boost immunity.
* Subject or legal representative who consent and has signed written informed consent.
* Subject who did't immune with any live vaccine within 14 days and inactivated vaccine within 7 days before vaccination.
* Subject and parent/guardian who is able to comply with all study procedures.
* Axillary temperature ≤37.0 ℃.

Exclusion Criteria:

* History of allergy，eclampsia, epilepsy, encephalopathy and mental disease or family disease.
* Allergic history after vaccination.
* History of meningitis infection disease.
* Acute Febrile illness and Infectious Diseases.
* Febrile illness (temperature ≥ 38°C) in the 3 days.
* Immunodeficiency diseases patients who administered with immunosuppressive agents.
* Children within 1 year old with abnormal labor, asphyxia rescue history,congenital malformations,genetic defects, eccyliosis or severe chronic disease.
* Liver and kidney or cardiopulmonary disease，acute hypertension and diabetes.
* In pregnancy or lactation or pregnant women.
* Subject who plan to participate in or is in any other drug clinical trial.
* Meningococcal vaccine contraindication.
* Any condition that, in the judgment of investigator, may affect trial assessment.
Improving Cancer Pain Management Through Self-Care

This study will test two different doses of a psychoeducational intervention to improve cancer pain management. In addition, the study will determine if the changes in pain management behaviors that the patients and family caregivers learn continue to be used when the intervention stops. It is hypothesized that patients and family caregivers who receive the high dose intervention will have a greater decrease in pain intensity scores.

Recent work from our research group demonstrated that the use of a 6-week psychoeducational intervention, called the PRO-SELF Pain Control Program, compared to standard care, resulted in clinically and statistically significant improvements in pain management in a sample of oncology outpatients with bone metastasis. While the overall effects of the intervention were significant, for approximately 70% of patients in the intervention group pain intensity scores did not decrease by \> 30% and that worst pain intensity scores remained at or above 4 at the end of the intervention. Therefore, as a logical extension of this study, we propose a randomized clinical trial (RCT) that will test the effectiveness of two different doses of the revised PRO-SELF Pain Control Program \[i.e., PRO-SELF PLUS-HIGH and PRO-SELF PLUS-LOW\] on pain intensity and analgesic prescriptions. In addition, the sustainability of the two doses of the intervention will be evaluated. Adult oncology outpatients with pain from bone metastasis will be recruited, stratified by site and by whether or not they participate alone or with a family caregiver, and randomized to one of the doses of the intervention. The psychoeducational intervention will be conducted by specially trained oncology nurses and will include the components of knowledge, skills training, and coaching to improve cancer pain management. Patients in both groups will be seen in their homes over the course of 10 weeks with phone calls conducted in between the home visits. Patients in the HIGH-DOSE group will receive 6 visits and 10 phone calls \[total time 12.3 hours\]. Patients in the LOW-DOSE group will receive 4 visits and 6 phone calls \[8.0 hours\]. Follow-up visits to assess the sustainability of the intervention will be done at 2 weeks, 1 month and 3 months after the intervention. Both quantitative and qualitative analyses will be conducted to evaluate patient outcomes.

Eligibility Criteria:
Inclusion Criteria:

* adult oncology outpatients (\> 18 years of age)
* able to read, write, and understand English
* agree to participate and give informed consent
* have a KPS Score of \> 50
* have an average pain intensity score of \> 3.0 on a 0 to 10 NRS
* have radiographic evidence of bone metastasis
* visceral or somatic pain
* have a life expectancy of at least 6 months
* are receiving outpatient treatment for cancer (not AIDS-related) with any single or combination therapy, and have a telephone line

Exclusion Criteria:

* A documented previous or current psychiatric disorder or if at the time of recruitment they are receiving hospice care in order not to interfere with the pain management program provided by hospice.
Study Of Irinotecan Hydrochloride (Campto(R)) And Cisplatin Versus Etoposide And Cisplatin In Small Cell Lung Cancer

To compare the effects of irinotecan hydrochloride with cisplatin to the "standard" regimen etoposide plus cisplatin on overall survival, in chemotherapy-naive patients with newly diagnosed Extensive Disease-Small Cell Lung Cancer (ED-SCLC).


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically proven Small Cell Lung Cancer (SCLC)
* WHO performance status : 0, 1

Exclusion Criteria:

* No previous radiotherapy is allowed except on bone metastases when newly diagnosed. Radiotherapy is not allowed for vena cava syndrome, a stent is recommended ;
* No prior surgery on the primary tumor except for palliative purpose (stent for vena cava syndrome).
PERCEVAL S Valve Clinical Study for Chinese Registration

This is a prospective, open, single arm, multi-center clinical study in China. The primary objective of this study is to demonstrate the safety and effectiveness of the PERCEVAL S heart valve when used to replace a diseased native or malfunctioning prosthetic aortic valve in the indicated Chinese population for tissue heart valve replacement and suitable to the PERCEVAL S valve.

The secondary objectives are to collect all relevant device and subject demographics, procedural and hospital discharge, short and long-term data, as described in the secondary endpoints section.


Eligibility Criteria:
Inclusion Criteria:

1. Subject of age \> 60 years.
2. Subject with aortic valve stenosis or steno-insufficiency.
3. Subject has signed the informed consent.
4. Subject in which preoperative evaluation is indicated for the need of native or prosthetic aortic valve replacement via open heart surgery
5. Subject is located in a geographic location that will enable the subject to return to the study site for follow-up examinations (i.e. geographically stable).

Exclusion Criteria:

1. Subject has preexisting valve prosthesis or annuloplasty rings in the mitral, pulmonic or tricuspid position.
2. Subject requires a double or multiple valve replacement or repair of the mitral, tricuspid, or pulmonic valve.
3. Subject requiring simultaneous cardiac procedures, apart from septal myectomy and/or coronary by-pass graft (CABG).
4. Subject has active endocarditis.
5. Subject has active myocarditis
6. Subject has aneurysmal dilation or dissection of the ascending aortic wall.
7. Subject is drug abuser, alcohol abuser, prison inmate, institutionalized, or is unable to give informed consent.
8. Subject has a major or progressive non-cardiac disease that, in the investigator's experience, results in a life expectancy of less than 1 year, or the implant of the device produces an unacceptable increased risk to the subject.
9. Subject with known hypersensitivity to nickel alloys.
10. Subject is undergoing renal dialysis for chronic renal failure or has hyperparathyroidism.
11. Subject has had an acute preoperative neurological deficit, myocardial infarction, or cardiac event that has not returned to baseline or stabilized for ≥30 days prior to the planned valve implant surgery.
12. Subject is known to be noncompliant or is unlikely to complete the study.
13. Subject with an aortic root enlargement, where the ratio between the diameter of the STJ and the annulus diameter, assessed by TEE, is \> 1.3. Or for other anatomical reasons that not suitable for PERCEVAL S per IB.
Pressure Levels on Lung Expansion

Question: What level of noninvasive positive airway pressure is able to expand the lungs of people with pleural drainage? Design: Cross-sectional, experimental and randomized study. Participants: Four consecutive people with pleural effusion drained within 24 hours, with controlled pain and without contraindications to use of noninvasive positive pressure. Intervention: Each person will be randomly subjected to three levels of noninvasive positive airway pressure: 0 (zero), 4 and 15 cmH2O for evaluation via chest computed tomography. Outcome measures: Lung area.


Eligibility Criteria:
Inclusion Criteria:

* age over 18 years
* presence of pleural drainage after traumatic hemothorax
* thoracic drainage within 24 hours
* controlled pain (below 3 points in the visual numeric scale, varying from zero to ten)

Exclusion Criteria:

* contraindication for use of noninvasive positive pressure in the airways, such as reduced level of consciousness (drowsiness, agitation or confusion), use of vasoactive drugs, complex arrhythmias, upper airway obstruction or trauma in the face, esophagus or upper airway, ineffective cough, inability to swallow, distended abdomen, nausea, vomiting, upper gastrointestinal bleeding
* previous application of any sort of lung expansion technique after thoracic drainage.
IL35 Level in Vitiligo

The aim of this observational study is to evaluate the level of the IL-35 protein in tissue biopsy from patients with active \& stable vitiligo.


Eligibility Criteria:
Inclusion Criteria:

* Patients with active and stable vitiligo

Exclusion Criteria:

* Pregnant and lactating women.
* Patients with associated autoimmune or other dermatological diseases e.g., Alopecia areata and lupus erythematous.
* Patients already on both topical and systemic treatment at the time of recruitment.
* Patients on Immunosuppressive drugs.
* Other hypopigmented diseases such as pityriasis alba, tinea versicolor, lichen sclerosis, post inflammatory hypopigmentation and leprosy as excluded by lack of accentuation by wood's light examination.
Asymptomatic Flu Project

Although clinical presentation of influenza is often symptomatic, asymptomatic cases also occur. The knowledge of the incidence of asymptomatic influenza among healthcare workers is very important because of the risk of cross-transmission to hospitalized patients. The principal objective of the study is to estimate the incidence of symptomatic and asymptomatic influenza among healthcare workers in short-stay wards. The results of this study will lead to a better understanding of the burden of asymptomatic influenza among healthcare workers and might be used as an argument to increase influenza vaccine coverage among healthcare workers.


Eligibility Criteria:
Inclusion Criteria:

* Volunteer health-care workers
* Working in the following wards: short-stay, inpatient (including ICU) and emergency

Exclusion Criteria:

* Presence of influenza symptoms at enrolment
* Programmed absence (maternity leave, vacation, etc.)
* Administrative agents
Modified Atraumatic Restorative Treatment Using CPP ACP

To evaluate the clinical and radiographic success of using Casein Phosphopeptide Amorphous Calcium Phosphate (CPP-ACP) under glass ionomer restorations in atraumatic restorative treatment as a biomimetic approach in pediatric dentistry.

With the growing popularity of ART in the field of pediatric dentistry, a great deal of research has been done in recent years. Researchers are keen to explore the rich possibilities and variations of ART technique that can help doctors practice better and do more for their patients. Alternatives include detours to regenerative dentistry, which is becoming more and more popular these days.

CPP ACP is still of great interest in the region due to its remineralizing action. However, to our knowledge, clinical and radiological success involving tissue regeneration by CPP-ACP is understudied. Furthermore, the studies conducted justify the need for further research on the use of CPP-ACP as an indirect material under glass ionomers in ART. Therefore, this study aims to conclude whether CPP ACP has added value in regenerating, reducing pain, and improving repair retention in caries-affected dentin lesions.

Eligibility Criteria:
* Inclusion Criteria:

Clinical Criteria:

Children aged 4-7 years. Apparently healthy children. Children with mild to moderate occlusal carious lesions in the mandibular second primary molar indicated for indirect pulp capping.

No history of spontaneous pain, pathologic mobility, draining sinus tract, redness or swelling of vestibule.

Normal gingival and periodontal condition, with no sensitivity to vestibular palpation, and no pain on percussion test.

Radiographic criteria:

* No sign of radiolucency in periapical or furcation area.
* No widening of PDL space or loss of lamina dura continuity.
* No evidence of internal/external pathologic root resorption.

Exclusion Criteria:

* Uncooperative children to avoid time waste and attrition bias.
* Children with systemic disease as some systemic diseases may have effect on the outcome Children with known allergy to any of the components being utilized. Molars near exfoliation.

Primary molars with more than half of the root resorbed or with periapical pathology as evident radiographically Mobile or ankylosed molars with no permanent successors

* Unable to attend follow-up visits to avoid attrition bias by decreasing number of drop off cases.
* Refusal of participation as the parent of child has the authority of participation.
A Multi-Center, Randomized, Double-Blind, Phase III Trial to Evaluate the Safety and Efficacy of Saxagliptin Co-administered With Dapagliflozin Compared to Saxagliptin or Dapagliflozin All Given as add-on Therapy to Metformin in Subject With Type 2 Diabetes

The aim of this study is to evaluate safety and efficacy of therapy with saxagliptin 5mg co-administered with dapagliflozin 5mg, compared to therapy with saxagliptin 5mg or dapagliflozin 5mg in patients who are inadequately controlled on ≥1500mg/day of metformin monotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged ≥18 years old at time of informed consent;
2. Patients with Type 2 diabetes mellitus (T2DM) defined as HbA1C≥7.5% to ≤10.0% at screening visit;
3. Stable metformin therapy for at least 8 weeks prior to enrolment at a dose of ≥1500mg per day;
4. BMI ≤45.0kg/m2 at Enrolment visit;
5. Fasting Plasma Glucose (FPG) ≤ 270mg/dl(15.0mmol/L) at the enrolment visit;
6. For Females Only: Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study and for at least 4 weeks after the last dose of study medication in such a manner that the risk of pregnancy is minimized.

Exclusion Criteria:

1. History of diabetes insipidus, Type 1 diabetes or Latent Autoimmune Diabetes of Adults, diabetic ketoacidosis or hyperosmolar nonketotic coma and Symptoms of poorly controlled diabetes that would preclude participation in this trial including but not limited to marked polyuria and polydipsia with greater than 10% weight loss during the 3 months prior to Enrolment (Visit 1), or other signs and symptoms.
2. History of pancreatitis.
3. Administration of any antihyperglycaemic therapy, other than metformin, for more than 14 days (consecutive or not) during the 8 weeks prior to enrolment
4. Any use of DPP-4 inhibitor or SGLT-2 inhibitor within 8 weeks prior to enrolment.
5. Significant hepatic disease, including, but not limited to, chronic active hepatitis and/or severe hepatic insufficiency and/or significant abnormal liver function, including patients with Alanine transaminase (ALT) and/or Aspartate transaminase (AST) ≥3x ULN (Upper Limit of Normal)and/or Total Bilirubin ≥2.0x ULN. History of severe hepatobiliary disease or hepatotoxicity with any medication. Positive serologic evidence of current infectious liver disease, including patients who are known to be positive for Hepatitis viral antibody ImmunoglobulinM (IgM), Hepatitis B surface antigen, and Hepatitis C virus antibody.
6. Moderate or severe impairment of renal function \[defined as Estimated Glomerular Filtration Rate (eGFR) \<60milliLitre/min/1.73 m2 (estimated by Modification in Diet and Renal Disease (MDRD)) or serum creatinine ≥1.5mg/dL in males or ≥1.4mg/dL in females\]. Conditions of congenital renal glucosuria, history of unstable or rapidly progressing renal disease.
7. History of any clinically significant disease or disorder which, in the opinion of the investigator, may put the patient at risk because of participation in the study, may influence the results, or may limit the patient's ability to participate in or complete the study.
Sofosbuvir Plus Ribavirin, or Ledipasvir/Sofosbuvir in Adults With HCV Infection and Renal Insufficiency

The primary objectives of this study are to evaluate the safety and efficacy of sofosbuvir (SOF) plus ribavirin (RBV) for 24 weeks and ledipasvir/sofosbuvir (LDV/SOF) for 12 weeks, and to evaluate the steady state pharmacokinetics (PK) of SOF and its metabolites and LDV in participants with genotype (GT) 1, 3, or 4 hepatitis C virus (HCV) infection who have chronic renal insufficiency (impaired kidney function).


Eligibility Criteria:
Key Inclusion Criteria:

* Cohorts 1 and 2: chronic genotype 1 or 3 HCV infection
* Cohort 3: chronic genotype 1 or 4 HCV infection
* HCV RNA ≥ 10\^4 IU/mL at screening
* Screening labs within defined thresholds
* Cirrhosis determination at screening

Key Exclusion Criteria:

* Females who are pregnant or nursing or males who have a pregnant partner
* Prior null response to pegylated interferon (Peg-IFN)+RBV therapy (Cohorts 1 and 2) or for individuals with cirrhosis, prior treatment failure with IFN-based therapy not resulting from treatment intolerance (Cohort 3)
* Current of prior history of hepatic decompensation
* Infection with hepatitis B virus (HBV) or HIV
* History of clinically significant illness (including psychiatric or cardiac) or any other medical disorder that may interfere with individual's treatment and/or adherence to the protocol

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
A Study of Nivolumab Plus Chemotherapy in First Line Treatment of Adult Participants With Advanced or Metastatic Gastric Cancer

The purpose of this observational study is to assess the effectiveness and safety of nivolumab in participants with previously untreated advanced or metastatic Gastric Cancer (GC), Gastro-oesophageal Junction (GEJ) Adenocarcinoma, or Oesophageal Adenocarcinoma (EAC).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of HER2 negative advanced or metastatic HER2-negative GC, GEJ adenocarcinoma or EAC whose tumours express PD-L1 with a CPS ≥ 5
* Whose physician has decided to start a treatment with nivolumab (according to the German marketing authorization) for the treatment of GC, GEJ adenocarcinoma or EAC and prior to study participation

Exclusion Criteria:

* Previous malignancy within 3 years or concomitant malignancy, except: those with a 5-year overall survival rate of more than 90%, e.g. non-melanomatous skin cancer or adequately treated in situ cervical cancer.
* Participants currently included in an interventional clinical trial for their advanced or metastatic GC, GEJ adenocarcinoma or EAC. Participants who have completed their participation in an interventional trial or who are not receiving any study drug anymore and who are only in the follow-up Phase for OS can be enrolled. For blinded studies, the study drug administered needs to be known at the time of enrolment.
Compensatory Brain Mechanisms for Amygdala-associated Cognitive Dysfunction: Potential Role of the Cortical Mirror Neuron System

Identify if the mirror neuron system, or other networks, can compensate for amygdala dysfunction, using behavior and structural/functional MRI.

In the present study, investigators aim to investigate amygdala dysfunction \& potential compensation in individuals with high and low traits (e.g. Autism, Anxiety, Depression traits, Alexithymia), high and low stress or protective factors in the environment (social network, early life stress) and different molecular genetic make-up. On the neural level, functional and structural connectivity as well as task-related BOLD activation will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects

Exclusion Criteria:

* history of head injury
* claustrophobia;
* medical or psychiatric illness
* female subjects were pregnant or taking oral contraceptives.
* taking any form of medication and drunk any caffeine-containing beverages on the day of the experiment.