louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01684527: Immature Myeloid Cells in Respiratory Syncytial Virus Bronchioliltis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bronchiolitis
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-09-13
Enrollment: 55
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children presenting in our pediatric department suffering from bronchiolitis

Brief summary: The investigators hypothesize that Respiratory Syncytial Virus (RSV) infection may influence the population of lung immature myeloid cells and dendritic cells in a way that will impair their ability to invoke an effective immune response and lead to prolonged inflammation, angiogenesis and scarring. This may lead in turn to disturbed lung function.

Our aim is to determine the presence and phenotype of immature myeloid cells present in respiratory secretions of children with RSV bronchiolitis as compared to non-RSV bronchiolitis and healthy controls.


Eligibility criteria: Inclusion Criteria:

* Bronchiolitis

Exclusion Criteria:

* Chronic disease

Primary outcomes:
measure: Number of Immature Myeloid Cells in Respiratory Secretions
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of one week
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
Clinical trial NCT05037227: Safety Profile Following Inactivated COVID-19 Vaccine in Healthy Adults Aged >18 Years in Indonesia
Official title: Safety Profile Following Inactivated COVID-19 Vaccine in Healthy Adults Aged >18 Years in Indonesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Safety Issues
Lead sponsor: PT Bio Farma
Sponsor class: INDUSTRY
First posted: 2021-09-08
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study is involving healthy adults aged \> 18 years.

Brief summary: The aim of this study is evaluating safety profile of COVID-19 Vaccine in healthy adults aged \>18 years in Indonesia.

Detailed description: To assess any serious systemic reaction within 30 minutes after COVID-19 vaccine immunization.

To assess systemic reaction after COVID-19 Vaccine immunization. To assess local reaction after COVID-19 Vaccine immunization. To assess any serious adverse event after COVID-19 Vaccine immunization.

Eligibility criteria: Inclusion Criteria:

* Clinically healthy adults aged \> 18 years.
* Subjects have been informed properly regarding the study and signed the informed consent form.
* Subjects will commit to comply with the instructions of the investigator and the schedule of the trial.

Exclusion Criteria:

* Subjects concomitantly enrolled or scheduled to be enrolled in another trial.
* Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with thermometer).
* Women who are lactating, pregnant or planning to become pregnant during the study period.
* History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
* Subjects who have any history of confirmed or suspected immunosuppressive or immunodeficient state, or received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long-term corticosteroid therapy (\> 2 weeks)).
* Subjects receive any vaccination within 1 month before and after IP immunization.
* Subjects plan to move from the study area before the end of study period.

Primary outcomes:
measure: Any serious adverse event occurring from inclusion until 30 minutes after the injection
timeFrame: Within 30 minutes after vaccination
Secondary outcomes:
measure: Local reaction and systemic events occurring within 30 minutes after each immunization.
timeFrame: Within 30 minutes after vaccination
measure: Local reaction and systemic events occurring within 28 days after immunization
timeFrame: 28 days
measure: Any serious adverse event during observation period.
timeFrame: 28 days
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Jakarta Provincial Ministry of Health
state: DKI Jakarta
Study officials:
affiliation: Indonesian Vaccine Safety Advisory Commitee
name: Julitasari Sundoro, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05771727: Impact of Covid-19 Pandemic on Children With Neuromuscular Disease and Their Parents in Turkey: Parent Perspective
Official title: Impact of Covid-19 Pandemic on Children With Neuromuscular Disease and Their Parents in Turkey: Parent Perspective
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuromuscular Diseases
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 134
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Parents of children with pediatric neuromuscular diseases

Brief summary: Parents of children with neuromuscular disease have been already at risk of depression, anxiety and burden. Additionally, the daily lives of children with neuromuscular disease and their parents have been significantly affected by the COVID-19 pandemic. Therefore, this study investigated parents' perspective on the effect of the COVID-19 pandemic on children with neuromuscular diseases and themselves.

Detailed description: The 55-item survey created by the researchers was applied online to determine the psychological and physical effects of COVID-19 on neuromuscular patients and their families. This survey also included the Content of the 9-Item Caregiver COVID-19 Limitations Scale (CCLS-9).

Eligibility criteria: Inclusion Criteria:

* taking care for a child with NMD whose age was between 0-18 years,
* having the ability to read and write Turkish language,
* having access to phone or e-mail,
* being volunteer.

Exclusion Criteria:

* having a child who have an additional diagnosis besides NMD and taking care of any other person in the family.

Primary outcomes:
measure: The questionnaire which created by the researchers
timeFrame: 30 minutes
Secondary outcomes:
measure: Content of the 9-Item Caregiver COVID-19 Limitations Scale (CCLS-9)
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References:
Clinical trial NCT02172027: Immunomagnetic Detection of Cancer Cells in Pleural Effusion in Lung Cancer Patients as Additional Staging and Prognostic Tool
Official title: Novel Immunomagnetic Detection of Cancer Cells in Pleural Effusion in Lung Cancer Patients as Additional Staging and Prognostic Tool
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Lung Cancer
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2014-06-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Lung cancer patients with pleural effusion at the Meir Medical Center Oncology Department or Lung Department.

Brief summary: Pleural effusion in lung cancer patients is one of the symptoms of metastatic disease that is inoperable and cannot be treated. Identification of cancer cells in the pleural effusion of lung cancer patients is a cytological test and serves as an initial diagnosis. These cells can then be used to prepare a cell block for staining and further tests.

In some research despite clinical suspicions, the cytological diagnosis is negative, due to the specimen containing too few cells or damage to the cells whilst the specimen is processed. A new method of identifying rare cells in a fluid is by immunomagnetic separation. Using this method, an antigen binds to proteins in the cell wall that are unique to tumor cells. When the fluid is passed through a magnetic field, separation occurs of the cells with the magnetic tags from the remainder of the cells. The separated cells can then be stained or cultured.

The currently approved method of immunomagnetic detection has been approved for clinical use in patients with breast cancer, cancer of the intestines and prostate cancer. An Israeli Biotech company has developed an advanced technology that allows identification of a larger number of cells without causing morphological damage to the cells.

The purpose of the current study is to examine the technique of immunomagnetic separation in pleural effusion of lung cancer patients in comparison to the cytological tests. In the future it is hoped that a larger number of patient samples will be included and further characterization of the cells will be possible to be compared to the clinical and cytological characteristics.


Eligibility criteria: Inclusion Criteria:

* Age 18 and over
* Lung Cancer Patients in the Lung Department or Oncology Department with spread to the pleural cavity.

Exclusion Criteria:

* Under age 18

Primary outcomes:
measure: To compare the method of Immunomagnetic detection to the current cytological test.
timeFrame: The samples will analyzed within a year
Secondary outcomes:
measure: The sensitivity of the technique of immunomagnetic separation compared to existing cytological techniques.
timeFrame: Within two years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04687527: Vitamin D Levels and Postoperative Pain in Laparoscopic Cholecystectomy
Official title: Effect of Vitamin D Levels on Postoperative Pain and Narcotic Analgesia in Patients With Laparoscopic Cholecystectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitamin D Deficiency
Postoperative Pain
Keywords: laparoscopic cholecystectomy
Vitamin D Deficiency
Postoperative Pain
Lead sponsor: Bozok University
Sponsor class: OTHER
First posted: 2020-12-29
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Volunteer patients undergoing elective laparoscopic cholecystectomy surgery by the Department of General Surgery

Brief summary: The deficiency of vitamin D is common in patients with gastrointestinal system disorders.

Vitamin D has been associated with chronic non-specific musculoskeletal pain and migraines due to anti-inflammatory effects.

This prospective observational study will undergo elective laparoscopic cholecystectomy surgery between 18 and 65 years, is planned to participate in ASA (American Society of Anesthesiologists) 1-3, 90 volunteer patients.

In preoperative evaluation, the remaining 3 ml of blood was centrifuged from the routine received blood to determine the level of vitamin D will be kept.

Postoperative will be applied to patient controlled analgesia to all patients for 24 hours.

To determine the level of postoperative pain, the visual analog scale (VAS) will be used in the clock unit and at the service 6, 12 and 24 hours.

In this study, the investigators aimed to test the hypothesis of relation to pain and opioid consumption in acute postoperative (24 hours) of perioperative low-vitamin D.


Eligibility criteria: Inclusion Criteria:

* Volunteer,
* Between the Ages Of 18-65,
* Least Primary School Graduate,
* Not Using Drugs That May Affect Cognitive Functions,
* Non-Alcohol Substance Use,
* Patients Without Psychiatric and Neurological Disease.

Exclusion Criteria:

* Those with known psychiatric disease and drugs,
* Those with an important cardiovascular or central nervous system disease,
* Patients with pain syndromes or routinely using opioid.

Very urgent patients

Primary outcomes:
measure: preoperative Vitamin D Level and postoperative pain in patients to undergo laparoscopic cholecystectomy operation
timeFrame: 6 months
Secondary outcomes:
measure: preoperative Vitamin D Level and opioid analgesic consumption
timeFrame: 6 months
Other outcomes:
Locations:
city: Yozgat
country: Turkey
facility: Bozok University Medical Center
Study officials:
affiliation: YOZGAT BOZOK UNIVERSITY
name: Ökkeş Hakan Miniksar, Asist.Prof
role: STUDY_CHAIR
References:
Clinical trial NCT02101827: Safety and Efficacy of Distending Media Infusion by Manual Syringe Method for Hysteroscopic Procedures
Official title: Safety and Efficacy of Distending Media Infusion by Manual Syringe Method for Hysteroscopic Procedures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hysteroscopic Surgery
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2014-04-02
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients had hysteroscopic procedures for either diagnostic or therapeutic purpose

Brief summary: To evaluate the safety and efficacy of manual syringe-infusion method in hysteroscopic procedures.

Detailed description: In order to minimize the amount of distending media infused during hysteroscopic procedures, investigators used manual syringe method for delivering of distending media during hysteroscopic procedures from June 2010 to November 2013 in our institute. The aim of this study was to evaluate the safety and efficacy of manual syringe-infusion method in hysteroscopic procedures.

The medical records of all women who received hysteroscopic procedures by manual fluid-infusion method or convention pump fluid infusion method between June 2010 and November 2013 will be reviewed. In order to reveal the superiority/inferiority of clinical outcome of women receiving manual fluid infusion method, perioperative outcomes will be compared.

Eligibility criteria: Inclusion Criteria:

* Of greater than twenty-year-old female patients suffering from abnormal uterine bleeding, suspected endometrial lesions, endometrial polyp, or submucous myoma.
* Patients had hysteroscopic procedures for either diagnostic or therapeutic purpose from June 2010 to November 2013 in Department of Obstetrics \& Gynecology in Far Eastern Memorial Hospital.

Exclusion Criteria:

* Female patients of less than twenty years-old.

Primary outcomes:
measure: Safety of manual fluid-distension methods for hysteroscopic procedures
timeFrame: 1 week
Secondary outcomes:
measure: Feasibility of manual fluid-infusion methods for hysteroscopic procedures
timeFrame: 1 week
Other outcomes:
Locations:
city: Banqiao
country: Taiwan
facility: Far Eastern Memorial Hospital
state: New Taipei
Study officials:
References:
Clinical trial NCT03080727: Intraobserver and Interobserver Reproducibility on Hip Clinical Assessment
Official title: Intraobserver and Interobserver Reproducibility on Hip Clinical Assessment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Joint
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
First posted: 2017-03-15
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male healthy subjects

Brief summary: The functional assessment of the hip joint is complex and challenging. Reproducible measures are necessary to identify changes in the structures and functionality of the hip joint over time and to evaluate the outcomes of treatments. A systematic evaluation process is critical to evidence-based practice. However, there are few studies investigating the reproducibility of these measures such as muscle strength, range of motion (ROM) and hip functionality in healthy subjects.

Detailed description: Twenty subjects were randomized in two different days: (1) First evaluation of muscle strength, range of motion and single-leg squat performed by the evaluator 1; (2) Repeat the first evaluation with 3 different evaluators

Eligibility criteria: Inclusion Criteria:

* No complaints of pain or knowledge of hip pathology
* Subjects willing to enroll

Exclusion Criteria:

* Subjects reporting that they can not perform the tests due to pain
* With previous surgery of the hip or pelvis;
* Diabetes Mellitus;
* Neuromuscular or neurological diseases;
* Cardiovascular diseases that prevent the realization of maximum voluntary effort;
* Subjects presenting positive hip clinical tests

Primary outcomes:
measure: Hip muscle strength
timeFrame: Day 1 (evaluator 1) and after 4 days of rest repeat measures on day 2 with 3 different evaluators
Secondary outcomes:
measure: Hip range of motion
timeFrame: Day 1 (evaluator 1) and after 4 days of rest repeat measures on day 2 with 3 different evaluators
Other outcomes:
measure: Single-leg squat
timeFrame: Day 1 (evaluator 1) and after 4 days of rest repeat measures on day 2 with 3 different evaluators
Locations:
city: Porto Alegre
country: Brazil
facility: Exercise Research Laboratory, School of Physical Education, Federal University of Rio Grande do Sul
state: Rio Grande do Sul
Study officials:
References:
Clinical trial NCT02376127: Metastatic Spinal Bone Marrow Response to Radiation Therapy Using T1 Weighted Dynamic Contrast-Enhanced Perfusion
Official title: Evaluation of Metastatic Spinal Bone Marrow Response to Radiation Therapy Using T1 Weighted Dynamic Contrast-Enhanced Perfusion
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Solid Cancer
Metastatic Spinal Lesions
Keywords: Dynamic Contrast-Enhanced Perfusion
14-203
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2015-03-03
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team at Memorial Sloan-Kettering Cancer Center (MSKCC).

Brief summary: The purpose of this study is to assess imaging methods including Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI) and perfusion for the cancer that has spread to the spine. The study aims to see if using these methods will help better see response to treatment with radiation in patients with spine metastases from any solid cancer.


Eligibility criteria: Inclusion Criteria:

* Adult patients 18 years of age or older
* Known pathological diagnosis of any solid cancer.
* Metastatic spinal lesions 1 cm or greater in diameter.
* Patients who are already eligible for and are to be treated with hypofractionated or single dose radiation for their spinal lesions.

Note: The patients must have their treatments at MSKCC.

Exclusion Criteria:

* Patients with renal failure or history of allergic reaction to Gadavist will be excluded.
* Patients who would be normally excluded from undergoing an MRI examination as per Memorial Hospital for Cancer and Allied Disease Screening Questionnaire for MRI.
* Patients with a pacemaker, aneurysm clip or any other condition that would warrant avoidance of a strong magnetic field.
* Patients with inability to cooperate for an MRI exam due to claustrophobia or high levels of anxiety.
* Female patients who are pregnant or nursing.
* Patients with eGFR \< 30 are not eligible to higher risk of NSF.

Primary outcomes:
measure: response to treatment
timeFrame: 2 years
Secondary outcomes:
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: Sasan Karimi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04255927: Triclosan-antibacterial Sutures Impact on the Incidence of Surgical Site Infection in Laparoscopic Surgeries.
Official title: Triclosan-antibacterial Sutures Impact on the Incidence of Surgical Site Infection in Laparoscopic Sleeve Gastrectomy, Laparoscopic Appendectomy or Laparoscopic Cholecystectomy; Multi-center, Double-blind, Randomized Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Laparoscopic Surgery
Surgical Wound
Surgical Site Infection
Lead sponsor: ClinAmygate
Sponsor class: OTHER
Collaborators: name: Misr University for Science and Technology
name: Al Safwa Hospital
name: Fayoum University Hospital
First posted: 2020-02-05
Enrollment: 912
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized-controlled
Primary purpose: PREVENTION

Brief summary: Comparing the incidence of PSI in cases using coated Polyglactin 910 suture with Triclosan and cases using Polyglactin 910 suture without Triclosan in laparoscopic sleeve gastrectomy, laparoscopic appendectomy or laparoscopic cholecystectomy.

Detailed description: In this prospective study, we will determine the incidence of PSI in Egypt as well as the impact of using coated polyglactin 910 sutures with Triclosan in lowering the incidence of PSI in laparoscopic sleeve gastrectomy, laparoscopic appendectomy or laparoscopic cholecystectomy.

Eligibility criteria: Inclusion Criteria:

* age 18-75
* candidate for laparoscopic surgical intervention during the period of the study were included.

Exclusion Criteria:

* Patient has immunodeficiency disorder.
* Patient receiving anti-cancer / immunosuppressive therapy.
* Patients with established pre-operative infection whether community acquired or hospital acquired either at / remote from the operative site.

Primary outcomes:
measure: port site infection (PSI)
timeFrame: 30 days
Secondary outcomes:
measure: hospital stay
timeFrame: 30 days
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Misr Univeristy for Science and Technology Hospital
Study officials:
affiliation: ClinAmygate
name: Emad R Issak, Diploma
role: STUDY_DIRECTOR
References:
citation: Ahmed I, Boulton AJ, Rizvi S, Carlos W, Dickenson E, Smith NA, Reed M. The use of triclosan-coated sutures to prevent surgical site infections: a systematic review and meta-analysis of the literature. BMJ Open. 2019 Sep 3;9(9):e029727. doi: 10.1136/bmjopen-2019-029727.