cyrilzakka/clinical-trials huggingface dataset:
Immunologic Response to FluMist vs. Flucelvax

The purpose of this study is to evaluate immunologic response to different types of influenza vaccine among children/adolescents/young adults 4-21 years of age. This is a randomized controlled trial (RCT), that will assess immune response in about 440 participants (about 220 per vaccine arm) pre- and post-vaccination to FluMist (live attenuated influenza vaccine given by nasal administration) and Flucelvax (egg-free cell-culture inactivated influenza vaccine).

This is a non-blinded, randomized controlled trial analyzing influenza vaccine immunogenicity response in children/adolescents/young adults aged 4-21 years given one of two FDA approved and licensed influenza vaccines: FluMist (live attenuated influenza vaccine by nasal administration) and Flucelvax (egg-free cell-culture inactivated influenza vaccine). This study will enroll about 440 healthy participants, about 220 per vaccine arm. Participants will be randomized in blocks of 4 using a 1:1 allocation to receive either FluMist or Flucelvax. Blood work will be conducted on all participants at baseline prior to vaccine receipt and post-vaccination at Day 7 (range 6-9 days) and Day 28 (range 21-35 days). The primary objective of the study is to determine pre- and post-serologic responses to each vaccine type.

Eligibility Criteria:
Inclusion Criteria:

* aged 4-21 years;
* has prior vaccination history available (which can be determined based either on medical record review or through state registry review);
* plans to receive the current seasonal influenza vaccination at one of the recruiting sites

Exclusion Criteria:

* unable or unwilling to completed required study activities, including informed consent, randomization to vaccine, and bloodwork;
* has already received influenza vaccine for the current season;
* has a known immunocompromising condition or is on an immunosuppressing medication (e.g., high dose steroids \>10 days);
* is known to be pregnant;
* has a history of severe allergy to eggs or to influenza vaccine or any of its components
Partial Implant-supported Rehabilitation Using PEEK

The goal of this observational study is to evaluate the outcome of a Poly-ether-ether-ketone - used in partial implant-supported rehabilitations after one year of follow-up. The main question it aims to answer is:

- What is the survival outcome of partial implant-supported prosthesis using Poly-ether-ether-ketone? The participants already rehabilitated with dental implants will receive a definitive 3 unit prosthesis incorporating Poly-ether-ehter-ketone.

Following the previous study on the full-arch rehabilitation of edentulous jaws using hybrid prostheses with polyetheretherketone (PEEK) infrastructure and acrylic resin teeth supported by implants in immediate function inserted through the All-on-4 concept it is necessary to further extend the evaluation to the partial rehabilitation using 3 Unit fixed prostheses supported by dental implants. To test this, the study design to be used will be a single-centre, prospective, observational cohort study to evaluate the short term outcome of fixed prosthetic implant-supported rehabilitations. The sample of this study consists in 10 patients consecutively treated. The cohort will be evaluated at 4 to 8 weeks, 6 months and 12 months after dental loading and annually thereafter as long as the patient is willing, regarding: prosthetic survival including repair and relining, implant survival, marginal bone resorption, incidence of mechanical complications \[loosening or fracture of prosthetic components), biological complications (peri-implant infection, suppuration, abscess, fistulae), patient tissue reaction, aesthetic examination including denture staining, colour stability and anatomic form; patients' in-mouth comfort and quality of life using the Oral Health Impact Profile OHIP-14 questionnaire; and assessment of prosthetic preparation (technician satisfaction), laboratory preparation time, clinical operative time and costs.

Eligibility Criteria:
Inclusion Criteria:

* Patients rehabilitated with dental implants and a 3 unit Bridge where the molars are missing in one jaw, with at least both canines present;
* Subjects who, in the opinion of the Investigator, are able to understand this clinical study, co-operate with the procedures and are willing to return to the clinic for all the required post-operative follow-ups;
* Subjects who are able to give voluntary, written informed consent to participate in this clinical study and from whom consent has been obtained.

Exclusion Criteria:

* Female Subjects who are pregnant;
* Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-ups or treatment outcomes;
* Subjects who are currently enrolled in a clinical study;
* Subjects requiring or currently having ongoing orthodontic treatment.
A Study of Aleglitazar in Combination With Oral Contraceptive Healthy Volunteers

This randomized, double-blind, placebo-controlled, cross-over study will assess the effect of aleglitazar on the pharmacokinetics and pharmacodynamics on Microgynon® in healthy volunteers. Volunteers will receive multiple oral doses of aleglitazar in one period; in the other period volunteers will receive placebo.


Eligibility Criteria:
Inclusion Criteria:

* Healthy female volunteer, 18 to 45 years of age
* Body mass index (BMI) between 18.0 and 29.9 kg/m2
* Body weight at least 55.0 kg
* Non-pregnant, not lactating and not planning pregnancy from screening to 3 months after the last dose of study treatment
* Non-smoker for at least 3 months

Exclusion Criteria:

* Currently active gynecological disorder
* History of amenorrhea within the previous 3 years
* Known or suspected history of estrogen-dependent neoplasia or sex hormone-dependent malignant tumors
* Use of steroid hormone-containing intrauterine device (IUD) or progesterone-release IUD contraceptive within 3 months to screening.
* History of clinically significant disease that could jeopardize the volunteer safety in the study
Oral Care to Prevent Ventilator-associated Pneumonia

This study was conducted to investigate the effect of oral care given by two different methods on the development of ventilator-associated pneumonia in patients connected to mechanical ventilators.

The universe of this research, which was designed as a semi-experimental study, is composed of patients connected to the mechanical ventilator lying in Atatürk University Training and Research Hospital Anesthesia and Reanimation Intensive Care Unit between September 2019 and February 2020. A total of 57 patients, 29 method-1, 28 method-2 groups, met the inclusion criteria of the study. In the data collection phase, 'Patient Identifier Information Form', 'Patient Monitoring Form', 'Oral Assessment Scale' and 'Tracheal Aspirate Culture Result Form' were used. In the evaluation of the data, number and percentage distributions, Kruskal Wallis, Mann Withney-U, Wilcoxon Analysis, Chi-Square test were used.

Eligibility Criteria:
Inclusion Criteria:• Patients on mechanical ventilator who have been in intensive care for at least 48 hours

* Male and female patients over the age of 18
* Patients without thrombocytopenia, leukopenia and oral stomatitis, aphthae, candiasis, gingivitis
* Patients whose respiratory support is provided by a mechanical ventilator
* Patients who are considered to be able to provide mechanical ventilator support for 7 days
* Patients without any respiratory-related infectious pathogens
* Obtaining informed consent from the patient if he/she can give consent or from his/her guardian if he/she is unable to give consent.
* It was determined as patients who did not undergo any intraoral surgical intervention.

Exclusion Criteria: patients with pneumonia Patients younger than 18 years

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The Detection of Circulating Tumor Cells (CTCs) in Breast Cancer With a Novel in Vivo Device

The GILUPI CellCollector® is the first in vivo CTC isolation product worldwide which is CE approved. Application data of CellCollector in China is not available now. The purpose of this clinical trial is to confirm the validation and safety of CellCollector in Chinese patients.


Eligibility Criteria:
Inclusion Criteria:

* Metastasis breast cancer confirmed with imaging examination
* Have agreed to undergo CTC analysis in vivo;
* ECOG：0-2

Exclusion Criteria:

* Non-metastasis breast cancer
Controlling ECC and Terminating Bottle-feeding Habits Among Toddlers Using a Modified Oral Care Package

This study will evaluate the effectiveness of oral health promotion in the prevention of ECC (early childhood caries) in bottle-fed children. Half of the patient will receive oral health promotion which emphasizing more on the benefit of stopping the bottle feeding habit, a free-flow cup and oral hygiene kit which include a toothbrush, toothpaste (1000ppm fluoride). The other half of the patient will receive standard of care oral hygiene promotion and oral hygiene kit which include a toothbrush, toothpaste (1000ppm fluoride)

In Malaysia, even though there are decreasing trend in caries prevalence from a survey conduct in 1995 to 2015 (87.1% 1995, 76.2% 2005 and 71.3% 2015) \[NOHPS 2015\], yet the difference is just 15.8% in a period of 20 years. One of the factors which contribute to the development of ECC in children in prolonged bottle-feeding. Many literatures had mentioned association of bottle feeding and ECC however there are no controlled studies done on the effect of bottle feeding and ECC. Despite antenatal oral health promotion program done by Ministry of Health Malaysia and incorporation of oral hygiene education and oral hygiene instruction during dental visit, the prevalence of ECC remains high. This study will provide evidence regarding the effectiveness of oral health promotion in preventing early childhood caries by early termination of bottle feeding in toddlers.

Eligibility Criteria:
Inclusion Criteria:

* Malaysian citizen
* Child age 12 to 24 months old
* Child with bottle feeding habit (patients from Klinik Kesihatan Ibu \& Anak (KKIA))
* Having at least 2 upper and 2 lower incisors at the time of recruitment
* A child is taken care of predominantly by their mother (housewife) or a single carer (maid/ grandmother)
* The parent who can read and write in Bahasa Melayu
* Full Term baby

Exclusion Criteria:

* Patient with medical problems
* Cleft lip or cleft palate or both
* Patient with a craniofacial anomaly
Fetal Hemoglobin Induction Treatment Metformin

The purpose of this study is to determine whether metformin is effective in the treatment for sickle cell anemia (SCA).

This is a dose escalation, pilot study for subjects with sickle cell anemia (SCA) disease to determine if metformin has a beneficial effect on the treatment and quality of life of SCA patients.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed diagnosis of sickle cell anemia
2. Age greater than or equal to 10 and less than or equal to 60 years of age.
3. If on hydroxyurea, fetal hemoglobin less than 20% at a stable dose (mg/kg) determined by the primary hematology provider over at least four months.
4. Creatinine less than or equal to 1.4 mg/dL and estimated glomerular filtration rate greater than 45 ml/min/1.73 m2
5. Liver function tests (specifically ALT and conjugated bilirubin) less than or equal to 4 times upper limits of normal.

Exclusion Criteria:

1. Failure to meet inclusion criteria
2. Simple or chronic red blood cell transfusion therapy in the last 3 months OR a HbA level greater than 5% in SCA patients
3. Refusal to use medically effective birth control if female and sexually active.
4. If on hydroxyurea, not at stable dose of hydroxyurea for a minimum of 4 months (temporary exclusion).
5. Creatinine greater than 1.4mg/dL
6. Liver function tests (ALT and conjugated bilirubin) greater than 4 times upper limits of normal.
Novel Mobile Application to Assess Dietary Information

The study will assess the accuracy of food capture methods using a novel mobile application. This will be done by comparing the energy and nutrient content of reported foods against those of foods actually consumed (i.e., reported vs actual). Two methods of using the application will be tested:

1. During each eating occasion to report foods and amounts consumed
2. By taking photographs of every food consumed, using the camera functionality of the mobile application and using the application the following day (according to the availability of the study subjects) to report foods and amounts consumed. This is to be consistent with the concept of a 24-hour dietary recall.

One group will use a standard 24-hour dietary recall method.


Eligibility Criteria:
Inclusion Criteria:

* Generally healthy men and women 18-65 years of age
* Eats a wide variety of foods from all food groups
* 18 ≤ body mass index (BMI) \< 30 kg/m2
* Ability to read and write in English
* iPhone (iOS 11 or higher) or Android phone (6 or higher) user willing to download the mobile application

Exclusion Criteria:

* Presence of active disease at screening that would prevent normal dietary intake and/or would result in weight loss (irritable bowel syndrome, Crohn's disease, celiac disease, etc.)
* Medical complications or chronic illness that would prevent full participation (e.g., active cancer)
* Pregnant or lactating women
* Diagnosed eating disorder
* Vegetarian
* Special dietary requirements or severe allergies that prevent the consumption of major food groups (e.g., gluten free, lactose free, Halal)
* Diagnosis of a mental health condition that has not been stable within the past 6 months
* Current or previous experience with dietary data collection or analysis
* Concurrent participation in another research study at any point during the study
* Availability and access to a tablet device (iPad, Android) only
* Shift workers
* Plan to partake in vigorous physical training/ exercise during the study period (e.g., training for or running a marathon)
Rh-Endostatin Combined With CCRT(50 Gy) Followed by Durvalumab Maintenance for the Treatment of Specific Phase III NSCLC

A Study to Assess the Effects of Durvalumab following Rh-Endostatin combined with reduced-dose CCRT(50 Gy) in Patients with Stage III Unresectable Non-Small Cell Lung Cancer who can not tolerate 60 Gy irradiation.

A Phase II, Single-arm, Multi-centre Study of Durvalumab as Sequential Therapy in Patients with Locally Advanced, Unresectable Non-Small Cell Lung Cancer (Stage III) Who Have Not Progressed Following Rh-Endostatin combined with reduced-dose CCRT(50 Gy) Therapy (Relief)

Eligibility Criteria:
Inclusion Criteria:

* Age at 18-75 years.
* Documented evidence of NSCLC (locally advanced, unresectable, Stage III)
* Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST)
* Eastern Cooperative Oncology Group performance status score (ECOG PS) of 0 to 1.
* Estimated life expectancy of more than 12 weeks.

Exclusion Criteria:

* Prior exposure to any anti-PD-1 or anti-PD-L1 antibody.
* Active or prior autoimmune disease or history of immunodeficiency.
* Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV.
* Evidence of uncontrolled illness such as symptomatic congestive heart failure, uncontrolled hypertension or unstable angina pectoris.
* Any unresolved toxicity CTCAE \>Grade 2 from the prior chemoradiation therapy.
* Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
The Effect of Blood Tests Performed Within the Routine Protocol in the Surgical Intensive Care Unit on Hemoglobin Levels

Examination of blood samples is inevitable in intensive care units. Routine blood samples can be an important cause for anemia. In this study, we aimed to examine how our blood collection routine affects hemoglobin values.

Blood tests for follow-up and treatment are widely used in intensive care units (ICU). Although its etiology is very diverse, phlebotomy performed due to frequent laboratory tests is among the preventable causes of anemia. In this observational study, blood tests performed on patients treated in intensive care units followed up in our clinic between 01.April.2023 - 31.May.2023 (2 months) will be examined. Patients' age, presence of additional disease, indication for admission to the unit, Acute Physiology and Chronic Health Assessment II (APACHE II), Sequential Organ Failure Assessment (SOFA) and Glasgow coma scale (GCS), hemoglobin values will be recorded. The daily blood test will record the amount of blood drawn for analysis (in milliliters), where it was taken from (peripheral, central venous or arterial catheter), and the amount of excess blood. Statistical analysis will be performed in terms of patient characteristics, routine blood volumes and development of anemia.

Eligibility Criteria:
Inclusion Criteria:

* Patients followed in the intensive care unit for more than 48 hours, ≥18-year-old

Exclusion Criteria:

* Patients not followed up by our clinic,≤18-year-old
MRCP Diagnoses EHCC Better When Combined DWI

Researching the diagnostic significance of Biliary Tract Neoplasm under combining DWI sequence with MRCP versus MRCP only separately.

The purpose of the study is to evaluate the usefulness of diffusion weighted imaging(DWI) combined with MRCP of 3.0T magnetic resonance imaging (MRI) in the evaluation of suspected malignant bile duct diseases. People with suspected Biliary Tract Neoplasm based on clinical symptoms (such as jaundice and thinness with unknown reasons) and CA-199 value raises are included.Diagnosis divided into two steps: the first one，only provide conventional MR sequences and MRCP images to make a diagnosis; the second step,provide the DWI images additionally, combining the image data before to make a diagnosis. Hypothesis is that DWI sequence should be regularly added into MRCP examination for improving diagnosis rate of Biliary Tract Neoplasm.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Suspected Biliary Tract Neoplasm based on clinical symptoms(such as jaundice and thinness with unknown reasons)and CA-199 raises（\>37U/mL）
* No evidence of clinical symptoms or CA-199 increase by non-bile duct cancerous factors(hepatitis,cholangeitis,stones)
* Age ≥ 16

Exclusion Criteria:

* Previous Biliary Tract Neoplasm surgery
* Contraindication for MRI (such as pacemaker or inner ear implant)
* Claustrophobia
* Age \< 16
Personalized Hemodynamic Therapy in Patients Undergoing High-risk Surgery

The purpose of this study is to evaluate the effectiveness of using the personal preoperatively assessed cardiac output in high-risk patients to guide perioperative administration of fluids and vasoactive drugs on predefined postoperative complications.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years undergoing a major abdominal procedure (including general, urological, gynaecological, and vascular) with an expected duration of surgery ≥ 90 min or presumed blood loss exceeding 1,000 mL (e.g., intrabdominal vascular surgery) and ≥ 1 of the following high-risk criteria:
* acute or chronic renal impairment (serum creatinine ≥ 1.3 mg/dL)
* predefined risk factors for cardiac or respiratory complications
* Immunodeficiency due to a therapy (e.g., immunosuppressants, chemotherapy, radiation, long-term or high-dose steroids)
* Immunodeficiency due to specific diseases (e.g., leukaemia, lymphoma, AIDS)
* severe liver impairment (biopsy proven liver cirrhosis plus 1 of the following: portal hypertension or history of upper gastrointestinal bleeding due to portal hypertension or previous episodes of hepatic insufficiency/hepatic encephalopathy/hepatic coma
* Age ≥ 80 years

Exclusion Criteria:

* Age \<18 years
* Pregnancy
* surgery for palliative treatment
* emergency procedure
* refusal of consent
* participation in another randomized controlled trial
* failure to meet inclusion criteria
Efficacy Study of Colistimethate Sodium Inhalation in Patients With Ventilator-associated Pneumonia

There might be additional benefit on clinical outcomes from adjunctive colistimethate sodium inhalation as therapy for multidrug resistant Gram-negative ventilator-associated pneumonia.

Besides, early antibiotics intervention might be benefit for patients with ventilator-associated tracheobronchitis or lower airway colonization with multidrug resistant Gram-negative bacteria.

Eligibility Criteria:
Inclusion Criteria:

1. age ≥ 20 years old
2. medical ICU patients with invasive ventilator use ≥ 48 hours
3. multidrug resistant Gram-negative bacteria obtained from lower respiratory tract

Exclusion Criteria:

1. pregnancy
2. concurrent use of other antimicrobial agents active for isolated multidrug resistant Gram-negative bacteria (as defined as resistant to carbapenem, fluoroquinolone, and anti-pseudomonas beta-lactams), such as tigecycline, aminoglycosides, and sulbactam
3. patients who refuse to receive any inhaled therapy
A Study To Estimate The Effect Of Repeated Dosing of PF-05175157 On The Pharmacokinetics Of A Single Dose Of Simvastatin In Healthy Adult Subjects

The study is designed to investigate the effect of repeated dosing of PF-05175157 on the pharmacokinetics of a single dose of Simvastatin in healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects with normal results in all screening examinations.
* Body Mass Index of 17.5 to 35.5 kg/m2

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, ocular, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Known history of intolerance to simvastatin or other statins.
External Validation of Models for Predicting Inadequate Bowel Preparation

In order to obtain the risk level of patients with intestinal insufficiency through simple indicators, many foreign scholars have studied and developed their own prediction models. However, the current guideline indicates that there is insufficient evidence to recommend the use of a specialized predictive model for clinical practice.There are few studies on external validation of existing prediction models.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing colonoscopy.
* patients older than 18 years.

Exclusion Criteria:

* Emergency colonoscopy.
* Have a serious medical condition, such as heart failure, acute liver failure, severe kidney disease (dialysis or predialysis patients) or New York heart association class iii-iv.
* Pregnant or breastfeeding.
* No bowel preparation or poor compliance (no bowel preparation as instructed or laxatives \< 90% of prescribed dose).
* Refuse to sign informed consent.
* The patient was rescheduled after the previous colonoscopy due to insufficient bowel preparation.
* Temporarily change to colonoscopy for other reasons.
* Incomplete colonoscopy due to insufficient parenteral preparation.
* Lack of complete data.