louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05292937: Incidence of Perioperative Hypothermia in Pediatric Patients
Official title: Incidence of Perioperative Hypothermia in Pediatric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypothermia; Anesthesia
Hypothermia Following Anesthesia
Keywords: hypothermia
intraoperative
perioperative
postoperative
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2022-03-23
Enrollment: 234
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients scheduled for any elective operation (except for open heart surgery) will be recruited.

Brief summary: Perioperative hypothermia is associated with many complications, including surgical site infections, delayed wound healing, coagulopathy, prolonged hospital and intensive care unit length of stay. Perioperative close monitoring of the body temperature is important, and this is recommended by many clinical practice guidelines. In this study the investigators aimed to detect the incidence of perioperative hypothermia in pediatric patients in the operating room, and to detect the possible associated risk factors.


Eligibility criteria: Inclusion Criteria:

* Any elective operation
* American Society of Anaesthesiologists (ASA) I-III physical status
* Age 0-18 years

Exclusion Criteria:

* Emergency operations
* ASA IV-V physical status
* Open heart surgeries
* Age \>=18 years

Primary outcomes:
measure: Body temperature
timeFrame: Perioperative
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University School of Medicine
state: Pendik
Study officials:
affiliation: Marmara University Department of Anesthesiology and Reanimation
name: Ruslan Abdullayev
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00219037: Long Term Safety of Aliskiren Alone or With the Optional Addition of Hydrochlorothiazide in Patients With Essential Hypertension
Official title: A 12 Month, Randomized, Open-label, Multicenter, Study to Assess the Long Term Safety of Aliskiren 150 mg Alone and 300 mg Alone or With the Optional Addition of Hydrochlorothiazide (12.5 mg or 25 mg) in Patients With Essential Hypertension.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Hypertension, blood pressure, aliskiren
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 1955
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Assess the long-term safety and tolerability of aliskiren, with the optional addition of HCTZ, in patients with essential hypertension, to ensure long term blood pressure control and protect against end organ damage.


Eligibility criteria: Inclusion Criteria

1. Patients with essential hypertension.
2. Patients who are eligible and able to participate in the study.

Exclusion Criteria

1. Severe hypertension.
2. History or evidence of a secondary form of hypertension.
3. History of hypertensive encephalopathy or cerebrovascular accident. Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Adverse events, laboratory abnormalities, serious adverse events
Secondary outcomes:
measure: Change from baseline in mean sitting diastolic blood pressure after 12 months
measure: Change from baseline in mean sitting systolic blood pressure after 12 months
measure: Change from baseline in standing systolic blood and diastolic pressure after 12 months
measure: Diastolic blood pressure less than 90 mmHg or reduction of 10 mmHg or greater from baseline
measure: Blood pressure less than 140/90 mmHg
Other outcomes:
Locations:
city: Investigative Sites
country: Germany
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Sica D, Gradman AH, Lederballe O, Kolloch RE, Zhang J, Keefe DL. Long-term safety and tolerability of the oral direct renin inhibitor aliskiren with optional add-on hydrochlorothiazide in patients with hypertension: a randomized, open-label, parallel-group, multicentre, dose-escalation study with an extension phase. Clin Drug Investig. 2011 Dec 1;31(12):825-37. doi: 10.1007/BF03256921.
Clinical trial NCT02113137: Oral Hygiene Procedures on Reduction of Oral Malodor
Official title: Effects of Various Oral Hygiene Procedures on the Reduction of Oral Malodor in Periodontally Healthy Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Halitosis
Keywords: halitosis
chlorine dioxide
tongue cleaning
Lead sponsor: Tokyo Medical and Dental University
Sponsor class: OTHER
First posted: 2014-04-14
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to evaluate the effect of various oral hygiene procedures on reduction of oral malodor.

Detailed description: Thirty volunteers who matched with including criteria were divided randomly into two groups. Both groups were instructed to brush their teeth with a scrubbing method for the first one week. Then, each group received the different additional oral malodor reduction regimen- in addition to tooth brushing tongue cleaning in one group and chlorine dioxide (ClO2) mouthwash in another group for three consecutive weeks. After that, all the participants were instructed to practice all the three oral hygiene procedures (tooth brushing, mouth washing, tongue cleaning) the last one week. Total volatile sulfur compounds (VSCs) measured by breathtron, tongue coating, plaque score and bleeding on probing (BOP) were outcomes of this study.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of oral malodor
* At least 20 functional teeth
* No systemic diseases
* No severe dental diseases

Exclusion Criteria:

* Habit of smoking and betel quid chewing
* Oral malodor by food and other craniofacial abnormalities
* Current use of any kind of mouthwash

Primary outcomes:
measure: Volatile sulfur compounds (VSCs)
timeFrame: 5 weeks
Secondary outcomes:
measure: Bleeding on probing
timeFrame: 5 weeks
measure: Tongue coating
timeFrame: 5weeks
measure: Debris index
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Department of oral health promotion
Study officials:
affiliation: Department of oral health promotion
name: EiEi Aung, student
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aung EE, Ueno M, Zaitsu T, Furukawa S, Kawaguchi Y. Effectiveness of three oral hygiene regimens on oral malodor reduction: a randomized clinical trial. Trials. 2015 Jan 27;16:31. doi: 10.1186/s13063-015-0549-9.
Clinical trial NCT02193737: Effects of Drinking at PACU Discharge After General Anaesthesia With Airway Control on Aspiration, Vomiting and Patients Comfort
Official title: Effects of Drinking at PACU Discharge After General Anaesthesia With Airway Control on Aspiration, Vomiting and Patients Comfort.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scheduled General Anaesthesia With Airway Control
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2014-07-18
Enrollment: 1555
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: National guidelines about post-operative fasting after general anesthesia are missing.

Current clinical practices are highly variable and no study has ever evaluated on a large scale the real risk of an early drinks recovery in postoperative period.

The aim of this study is to state the impact of early drinks recovery after general anesthesia with laryngeal mask or endotracheal intubation on the risk of aspiration.


Eligibility criteria: Inclusion Criteria:

* Scheduled surgery
* General anaesthesia with laryngeal mask or endotracheal intubation.
* Length of surgery \< 4 hours

Exclusion Criteria:

* Emergency surgery
* Intra-cranial, cervical or Ear, Nose and Throat surgery
* Guts surgery with guts anastomosis.
* Glottic topical anesthesia
* Patient with nasogastric tube
* Aspiration during surgery or during PACU stay

Primary outcomes:
measure: To determine if early oral fluid recovery after an elective surgery under general anaesthesia with endotracheal intubation or laryngeal mask increasethe incidence of cough during swallowing, ie aspiration.
timeFrame: 1min
Secondary outcomes:
measure: To determine if early oral fluid recovery (i.e patient discharged of PACU) after general anaesthesia increases post-operative vomiting during first hour and patient comfort rated on a 10 points scale.
timeFrame: 1 hour
Other outcomes:
Locations:
city: Poitiers
country: France
facility: University Hospital of Poitiers
state: Vienne
Study officials:
References:
Clinical trial NCT04265937: ScreenIng of Genetic Susceptibility Genes for Breast Cancer Patients in CHinese communiTies
Official title: Screening of Genetic Susceptibility Genes for Breast Cancer Patients and Establishment of High-risk Populations in Chinese Communities
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Genetic Susceptibility
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2020-02-12
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Breast cancer patients from community.

Brief summary: This is a community-based prospective study and the research object is breast cancer patients. It is planned to take the community as the unit to inform and collect the breast cancer patients who voluntarily participate to carry out the detection of BRCA1, BRCA2, PTEN, CHEK2 and PALB2 genes through the community health service center.

Detailed description: This is a population-based, prospective, cohort study which has been ongoing in 3 provinces of eastern China since 2019. Up to 5000 breast cancer survivors will conduct BRCA1, BRCA2, PTEN, CHEK2, and PALB2 genetic susceptibility genes testing, fill in clinical and genetic information forms, and collect family history. Mutation rate of BRCA1/2 and other genetic susceptibility genes in Chinese community breast cancer population will be measured. Logistic regression will be performed to establish a prediction model for the probability of BRCA1/2 and other gene mutations. Kin-Cohort method will be used to calculate the penetrance of breast cancer and other common malignancies in BRCA1/2 and other genetic mutation carriers.

Eligibility criteria: Inclusion Criteria:

* breast cancer patients of any age;
* both male and female;
* the subjects signed the informed consent to participate in the study and abide by the study procedure before being selected.

Exclusion Criteria:

* healthy people or other malignant tumor patients without breast cancer;
* unable to interview the investigator and sign the informed consent due to any reason;
* it is impossible to collect peripheral blood or oral mucosa samples for any reason.

Primary outcomes:
measure: The frequency of pathogenic or likely pathogenic variants of BRCA1/2 and other genetic susceptibility genes in Chinese community breast cancer population
timeFrame: 1 year
Secondary outcomes:
measure: Prediction model of Genetic Susceptibility Gene (BRCA1/2 etc) mutation probability
timeFrame: 1 year
measure: Breast cancer penetrance of Genetic Susceptibility Gene (BRCA1/2 etc) carriers
timeFrame: 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhen Hu
state: Shanghai
Study officials:
References:
Clinical trial NCT02676037: Diagnosis of Hallux Valgus by Using a Foot Pressure Platform as an Alternative to Radiological Images
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hallux Valgus
Lead sponsor: University of Dundee
Sponsor class: OTHER
First posted: 2016-02-05
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will come from an existing list of patients referred to the Foot Pressure Analysis Clinic and will include any patients who are diagnosed with HV. They will be recruited with the knowledge of the consultant orthopedic surgeons who are the direct care providers for these patients. The surgeons will write to eligible participants and include a Patient Information sheet about the project (which does not require to record data beyond what is normally performed as part of the Foot Pressure Analysis Clinic) If the participant is interested in taking part he/she will contact the department.

Brief summary: Hallux Vagus is a common deformity which affects the first metatarsalphalangeal joint. The current diagnostic tool is using X-ray which is expensive and includes radiation exposure. The current study is aimed at using the foot pressure platform as an alternative method for diagnosis and evaluation of the deformity. The main subjects will be recruited from orthopaedic outpatient clinics.

The recruited subjects will undergo the non-invasive and radiation free study by walking on a pressure platform. Then their pressure data will be correlated with their radiological study which has already been done in the clinic. The aimed outcome of the study is use the foot pressure platform as first line of diagnosis and evaluation of the Hallux Valgus deformity.


Eligibility criteria: Inclusion Criteria:

* Patients who are diagnosed with hallux valgus.
* Patients who are diagnosed with hallux valgus and scheduled for surgery ( to be seen pre and post-surgery)
* Patient who are diagnosed with hallux valgus and had surgery

Exclusion Criteria:

* Any other foot deformity
* Previous foot surgery (which is not related to HV

Primary outcomes:
measure: - To provide a safe diagnostic tool (radiation free) for evaluating the severity of the HV by using a foot pressure platform
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03732937: Estimation of Gestational Age by TCD
Official title: Estimation of Gestational Age by Transcerebellar Diameter in Normal and Abnormal Pregnancy States
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gestational Age and Weight Conditions
Lead sponsor: Aljazeera Hospital
Sponsor class: OTHER
Collaborators: name: National Research Centre, Egypt
First posted: 2018-11-07
Enrollment: 700
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pregnant ladies with GA between 16 - 40 weeks

Brief summary: - Different parameters are used to estimate gestational age AC, HC , BPD and FL

Detailed description: -TCD is one of the parameters ,here we are testing its accuracy in calculating GA

Eligibility criteria: Inclusion Criteria:

* pregnant ladies with GA between 16 - 40 weeks

Exclusion Criteria:

* pregnant ladies with GA less than 16 weeks

Primary outcomes:
measure: The number of participants who will be exactly dated by TCD in comparison to LMP
timeFrame: within 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Algazeerah and Kasralainy hospital
Study officials:
affiliation: Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
name: Mahmoud Alalfy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00586937: Quality of Life in Lung Cancer Survivors
Official title: Quality of Life in Lung Cancer Survivors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer Survivors
Keywords: Lung Cancer Survivors
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Fox Chase Cancer Center
First posted: 2008-01-07
Enrollment: 193
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Thoracic Surgery Database

Brief summary: The purpose of this study is to find out about the quality of life of individuals who have been diagnosed and treated for lung cancer (lung cancer survivors). By quality of life, we mean how you are feeling about different aspects of your life, including your physical health, your emotional health, and your ability to carry out daily activities. We are interested in people's opinions about their quality of life, as well as the factors that affect their quality of life. Learning about quality of life will help us to develop new services for lung cancer survivors.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of primary Stage IA or IB NSCLC;
* Underwent surgical resection for NSCLC at MSKCC;
* From 1 to 5 years and 11 months post-treatment for NSCLC prior to study recruitment;
* No evidence of disease (NED) at the time of recruitment;
* Can be reached by telephone;
* Able to provide informed consent.

Exclusion Criteria:

* Undergoing active antineoplastic treatment;
* Major psychopathology or cognitive impairment likely in the judgment of the investigator to interfere with participation and compliance with the protocol.

Primary outcomes:
measure: To describe the health-related quality of life (HQOL) of lung cancer survivors and compare their HQOL with age- and gender-appropriate, population-based normative data.
timeFrame: 2 years
Secondary outcomes:
measure: To describe and identify covariates of HQOL in lung cancer survivors.
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jamie Ostroff, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06210737: A Study to Evaluate Persistence of Immunity of PCV13 in Healthy Population Aged 2 Months，7 Months-5 Years
Official title: A Study to Evaluate Persistence of Immunity of PCV13 in Healthy Population Aged 2 Months，7 Months-5 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pneumonia
Lead sponsor: Beijing Minhai Biotechnology Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-01-18
Enrollment: 621
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to learn about persistence of immunity of PCV13 in healthy population aged 2 months, 7 months-5 years. The main questions it aims to answer are the percentage of subjects reached the IgG level of ≥0.35 µg/mL, GMCs level for IgG antibody, and SAEs from one month to 12 months after the last injection.


Eligibility criteria: Inclusion Criteria:

* Those who have participated in the Phase III clinical study of Beijing Minhai PCV13 and have been fully vaccinated with Minhai PCV13;
* An informed consent was required to sign by their legal guardians;
* Volunteers and their legal guardians/caregivers were able to attend the study visit as required by the protocol.

Exclusion Criteria:

* Those who had any administration history of pneumococcal polysaccharide or conjugate vaccine after participating in the Phase III clinical study;
* Prior to enrollment, patients who had a history of pneumococcal infection with one or more of the well-defined PCV13 serotypes;
* The researchers shall judge the other conditions which might be not in compliance with the requirements of this clinical trial.

Primary outcomes:
measure: percentage of subjects reached the IgG level of ≥0.35 µg/mL
timeFrame: 2-5 years after the first dose
measure: GMCs level for IgG antibody
timeFrame: 2-5 years after the first dose
measure: Serious Adverse Events (SAE)
timeFrame: one months to 12 months after the last injection
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Provincial Center for Diseases Control and Prevention
state: Jiangsu
Study officials:
References:
Clinical trial NCT02943837: EUS-guided Fine Needle Aspiration (EUS-FNA) Versus EUS-guided Fine Needle Biopsy (EUS-FNB) for Diagnosis of Subepithelial Tumors
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Gastrointestinal Subepithelial Tumors
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2016-10-25
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Background: Preoperative pathologic diagnosis of subepithelial tumor (SET) can improve clinical decision making. Although EUS-guided fine needle aspiration (FNA) is currently considered the standard method for sampling SET, its diagnostic yield is generally suboptimal. EUS-guided fine needle biopsy (FNB) of SET is safe and feasible with adequate histology obtained.

Objective: To compare the diagnostic accuracy of EUS-FNA and EUS-FNB.


Eligibility criteria: Inclusion Criteria:

* Esophageal, gastric, or duodenal SET over 2 cm
* Hypoechoic lesion including 4th layer on EUS

Exclusion Criteria:

* SET with characteristic findings such as lipoma, vessels, or ectopic pancreas
* bleeding or rupture of SET
* platelet count \<50,000 or prothrombin time INR \> 1.3

Primary outcomes:
measure: Diagnostic accuracy (proportion of correctly classified subjects (ture positive + true negative) among all subjects ) , compared to the gold standard diagnosis
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: