louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05214300: Screening for Bleeding Disorders in Children
Official title: Screening for Bleeding Disorders in Children: Evaluation of the Elements of the Interrogation, the Screening Workup and the Clinical Scores
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bleeding Disorder
Keywords: von Willebrand disease
hemophilia A and B
other coagulant factor deficiencies
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2022-01-28
Enrollment: 96
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children 0-18 years old

Brief summary: The investigators try to improve the screening of bleeding disorders in children by identifying symptoms, laboratory abnormalities and clinical scores discriminating patients congenital bleeding disorders in order to create a simple screening algorithm applicable in pediatrics, aiming for use in pre-anesthetic consultation and in consultation by pediatricians and general practitioners.

Detailed description: Objective : To determine simple clinical and biological factors that can improve the screening of hemostatic diseases at risk of hemorrhage in children.

Method:

* Retrospective inclusion of all patients \<18 years referred to the CRTH in pediatric consultation for the reason of exploration of a hemorrhagic syndrome or exploration of an anomaly in the hemostasis assessment.
* Data collected (by collection in the medical file):

Patient data: Age, sex, personal and family history of hemorrhagic disease

Clinical data: hemorrhagic symptomatology (epistaxis, gingivorrhagia, etc.) Biological data: PT, TCK, factor assay, platelet function Medical data: complete diagnosis if diagnosis of hemorrhagic disease

* Scores: HEMOSTOP, PBQ, ISTH, TOSETTO score
* Analyzes: calculation of the Odd Ratio, AUC, Se, Sp, VPP, VPN for different clinical / biological factors and each score.

Eligibility criteria: Inclusion criteria:

* referred by their general practitioner or another caring physician for evaluation of bleeding symptoms
* abnormal laboratory test results or family study
* the patient being the first-degree relative of a patient with a known bleeding disorder.

Exclusion criteria:

- older than 18 years old.

Primary outcomes:
measure: Observe the correlation between the data of the interrogation
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
measure: Test scores
timeFrame: day 1
measure: Compare several scores
timeFrame: day 1
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Alexandre THERON
role: STUDY_DIRECTOR
References:
Clinical trial NCT01626300: The Effect of Milk Components on the Response to the Pneumonia Vaccine in Senior Citizens
Official title: The Effect of Milk Components on the Response to the Pneumonia Vaccine in Senior Citizens: A Randomized Placebo-controlled Clinical Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: The Effect of Milk Components on the Response to Pneumococcal Vaccines in the Elderly
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2012-06-22
Enrollment: 45
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy subjects \> 60 years of age.

Brief summary: The purpose of this study is to determine if the daily use of a certain amount and type of milk component for 2 months provides a significant stimulation to the immune system and specifically increases the chances of being protected against pneumonia after the vaccination.


Eligibility criteria: Inclusion Criteria:

* Age and a willingness to participate

Exclusion Criteria:

* • Smoking history within 10 years

  * Underlying neoplasia or immunological disease
  * Use of oral cortisone or other immunosuppressive agents
  * Current consumption of milk and milk products greater than 1 unit of milk, 1 yogurt, or 1 serving of fresh cheese a day.
  * Food faddists or those taking a non-traditional diet
  * Current consumption of dietary supplements
  * People with a known history of milk allergy
  * People with chronic renal failure
  * People with chronic inflammatory diseases taking daily doses of NSAIDs for longer than 4 weeks at the time of enrollment.
  * Previous administration of the pneumomax vaccine
  * Reduced physical activity (i.e. NYHA classes III-IV)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04945200: Neoadjuvant Immune Checkpoint Inhibitor Combined With Chemotherapy in Non-small Cell Lung Cancer
Official title: Neoadjuvant Immune Checkpoint Inhibitor Combined With Chemotherapy in Non-small Cell Lung Cancer: Clinical Response and Biomarkers Analysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-small Cell Lung Cancer
Keywords: non-small cell lung cancer, neoadjuvant, biomarker
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-06-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: stage IB-IIIA NSCLC

Brief summary: The primary object of this study is to determine tumor major pathological response (MPR) rate and pathologic complete response (pCR) rate in stage IB-IIIA non-small cell lung cancer who subjected to neoadjuvant immune checkpoint inhibitor combined with chemotherapy and molecular biomarkers related to the clinical response.


Eligibility criteria: Inclusion Criteria:

1.Able to understand the nature of this trial and provide written informed consent.

2.18 years ≤ age ≤ 80 years

3.Histologically documented non-small cell lung cancer

4.NSCLC with resection option for potential cure.This may include clinical stage IB, II and IIIA.

5.Subjected to neoadjuvant immune checkpoint inhibitor combined with chemotherapy according to disease evaluation.

6.Measurable disease by RECIST v1.1

7.Tumor tissue sample and/or alveolar lavage fluid must be available for biomarker evaluation before operation.

Exclusion Criteria:

1. Subjects are excluded if they are enrolled in any other interventional studies.
2. Administration of chemotherapy, device therapy or any other cancer therapy in 4 weeks before the study drug administration.
3. Subjects are excluded if they have an active, known or suspected autoimmune disease requiring systemic treatment (e.g.corticosteroids or other immunosuppressive medications) in 2 years before the study drug administration. substitution therapy ( e.g. thyroxine, insulin) are permitted.
4. Subjects with active concurrent malignancies are excluded i.e. cancers other than NSCLC.
5. History of allergy to study drug components
6. Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results.
7. Any other conditions that, in the Investigator's opinion, unfit to attend this study.

Primary outcomes:
measure: molecular biomarkers related to clinical response
timeFrame: change from baseline to postoperation, an average of 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT06715800: Honey Against Sore Throat
Official title: Symptomatic Relief of Sore Throat With Functional Honey: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sore Throat
Honey
Keywords: Sore throat
Apitherapy
Functional Honey
Lead sponsor: Medipol University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2024-12-04
Enrollment: 282
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind, Randomized, Controlled Trial
Primary purpose: TREATMENT

Brief summary: Objective: The aim of this study is to investigate the symptomatic efficacy of oral use of different functional honeys in patients complaining of sore throat.

Materials and Methods: In the preclinical phase of the study, a total of 1000 samples of honey were examined, and the honeys were subjected to physicochemical and microbiological analyses. Based on their functional properties, five different groups of honey were determined. These are thyme honey with high antioxidant capacity, Yüksekova with high antimicrobial activity, chestnut honey with high organic acid amount, linden honey with high enzymatic and pine honey with high anti-microbial, antioxidant and phenolic compounds and enzymes. In the clinical phase of the study, patients receiving conventional treatment were randomly assigned to receive either one of five different types of honey or a honey-like food product in addition to their treatment. They were instructed to use 15 grams twice daily for 10 days. Patients were assessed on the 1st, 3rd, 7th, and 10th days for symptoms and complaints such as sore throat, difficulty swallowing, sensation of throat swelling, weakness, and fatigue.


Eligibility criteria: Inclusion Criteria: Adults presenting with sore throat symptoms due to an upper respiratory infection (URI) within the last four days were included in the study. A total of 300 patients over 18 years of age, who were prescribed necessary medication and exhibited signs and symptoms of sore throat, were enrolled.

Exclusion Criteria: Exclusion criteria included a history of diabetes, pollen or bee allergies, and aversion to honey. Participants were required not to use any additional products outside of those provided by the researchers during the study period. Written informed consent was obtained from all participants, who were then randomly assigned to either the study or control group.

Primary outcomes:
measure: Clinical Symptome
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University
Study officials:
References:
Clinical trial NCT01919437: Comparison of Methamphetamine-Dependent and Healthy Volunteers Using a Web-Enabled Cognitive Neuropsychological Evaluation System
Official title: Comparison of Methamphetamine-Dependent and Healthy Volunteers Using a Web-Enabled Cognitive Neuropsychological Evaluation System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Methamphetamine Dependence
Lead sponsor: California Pacific Medical Center Research Institute
Sponsor class: OTHER
Collaborators: name: Creare, Inc.
First posted: 2013-08-09
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to develop the technology infrastructure for a mobile Web-based cognitive and neuropsychological assessment of substance abusers, and to perform a pilot trial using neurocognitive tasks designed to demonstrate that our system is statistically comparable to current clinical practice.

The primary hypotheses are that results collected using a web-based data collection platform will be comparable (but not necessarily equivalent) to data collected under controlled laboratory conditions, that methamphetamine (MA) dependent participants will have worsened neurocognitive performance compared to healthy volunteers, and the platform will be acceptable to participants.


Eligibility criteria: Inclusion Criteria:

* Male or female, aged 18 to 55.
* Ability to give informed consent.

Exclusion Criteria:

* Unwilling or unable to access the web over a cell phone or living in an area with no cell phone service.
* Any medical, psychiatric, or other condition that, in the opinion of the investigator, would preclude safe, consistent, or useful participation in the study.

Primary outcomes:
measure: Comparison of neurocognitive task results
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: CPMC Addiction & Pharmacology Research Laboratory
state: California
Study officials:
References:
Clinical trial NCT02180737: Dexmedetomidine for Sedation During Radiological Interventional Procedures
Official title: Evaluation of Role of Dexmedetomidine as a Sole Agent in Sedation of Cancer Patients Undergoing Radiological Interventional Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Procedural Sedation
Keywords: dexmedetomedine
sedation
interventional radiology
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2014-07-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluation of the role of dexmedetomidine as a sole agent in sedating patients undergoing interventional radiological procedures and measuring its different outcome variables.


Eligibility criteria: Inclusion Criteria:

* Age from 18-65 years old
* ASA physical status of I-II
* Expected procedure lasting at least 30 minutes

Exclusion Criteria:

* Unstable cardiac status (life-threatening arrhythmias, abnormal cardiac anatomy, significant cardiac dysfunction and third-degree heart block.
* An alpha2-agonist or antagonist within 14 days before the scheduled procedure.
* patients received an IV opioid within 1 h, or an oral or IM opioid within 4 h of the start of study drug administration.
* Patients who are allergic to Dexmedetomidine or alpha 2-agonists.

Primary outcomes:
measure: Degree of sedation
timeFrame: 1 hour
measure: verbal analogue scale
timeFrame: 1 hour
Secondary outcomes:
measure: patient satisfaction
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Cancer Institute-Egypt
Study officials:
affiliation: National Cancer Institute (NCI)
name: Wafaa T Salem, MD
role: STUDY_CHAIR
affiliation: National Cancer Institute (NCI)
name: Maie K Helaly, MD
role: STUDY_DIRECTOR
affiliation: National Cancer Institute (NCI)
name: Ghada M Bashandy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Institute (NCI)
name: Ayat A Hassan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hsu YW, Cortinez LI, Robertson KM, Keifer JC, Sum-Ping ST, Moretti EW, Young CC, Wright DR, Macleod DB, Somma J. Dexmedetomidine pharmacodynamics: part I: crossover comparison of the respiratory effects of dexmedetomidine and remifentanil in healthy volunteers. Anesthesiology. 2004 Nov;101(5):1066-76. doi: 10.1097/00000542-200411000-00005.
citation: Scher CS, Gitlin MC. Dexmedetomidine and low-dose ketamine provide adequate sedation for awake fibreoptic intubation. Can J Anaesth. 2003 Jun-Jul;50(6):607-10. doi: 10.1007/BF03018650.
Clinical trial NCT00822237: Study to Test the Safety and Immunogenicity of VARIVAX (2007 Process) (Study V210-057) (Completed)
Official title: Safety, Tolerability, and Immunogenicity of VARIVAX (2007 Commercial VZV Bulk Process) Administered Concomitantly With M-M-R II in Healthy Children 12-to-23 Months of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Varicella
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-01-14
Enrollment: 598
Sex: ALL
Minimum age (years): 12
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will test the safety, tolerability, and immunogenicity of VARIVAX manufactured with the 2007 commercial Varicella-Zoster Virus (VZV) bulk process when concomitantly administered with M-M-R II in healthy children.

Detailed description: This treatment has been approved for sale to the public.

Eligibility criteria: Inclusion Criteria:

* Subject is in good health based on medical history
* Subject has no history of measles, mumps, rubella, chickenpox, or shingles

Exclusion Criteria:

* Subject has previously received measles, mumps, rubella, and/or varicella vaccine either alone or in combination
* Subject has history of immune disorders
* Subject has been exposed to chickenpox/shingles, measles, mumps, rubella or varicella within 4 weeks of study start
* Subject has received an inactivated vaccine within 14 days of first dose of study vaccine
* Subject has received a live vaccine within 30 days of first dose of study vaccine
* Subject has received a blood transfusion or blood-derived products within 3 months of receiving study vaccine
* Subject has had a fever within 72 hours of study start

Primary outcomes:
measure: Percent of Participants Who Achieved Varicella Immunogenicity After a Single Dose of VARIVAX (2007 Process).
timeFrame: 6 weeks following first vaccination
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04304937: Validation of Swedish Short PROM för Venous Insufficiency
Official title: Validation of a Swedish Version of a Short Patient-Reported-Outcome-Measure for Superficial Venous Insufficiency
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Superficial Venous Insufficiency
Quality of Life
Change After Treatment
Keywords: Patient reported outcome measure
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Skandinaviska Forskningsstiftelsen för Åderbråck och andra Vensjukdomar
First posted: 2020-03-12
Enrollment: 257
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: consecutive patients at chosen clinics diagnosed with superficial venous insufficiency C2-C6

Brief summary: Validation of a new short Swedish patient reported outcome measure for superficial venous insufficiency. Analysis of its capacity to measure quality of life and its responsiveness to change caused by treatment.


Eligibility criteria: Inclusion Criteria:

* agrees to participate, diagnosed with superficial venous insufficiency C2-C6

Exclusion Criteria:

* does not want to participate, less than C2, does not submit the answered questionnaires

Primary outcomes:
measure: the short PROM is valid for measurement of quality of life and detects change caused by treatment
timeFrame: baseline and 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Karlskoga
country: Sweden
facility: Karlskoga venöst centrum
city: Malmö
country: Sweden
facility: Åderbråckscentrum
city: Stockholm
country: Sweden
facility: Narvakliniken Åderbråck
Study officials:
References:
Clinical trial NCT02939937: Effect of Phenytoin on the Ganglion Cell Layer in Patients With Optic Neuritis
Official title: a Phase II Double Blind, Randomized, Placebo Controlled Trial of Effect of Phenytoin on the Ganglion Cell Inner Plexiform Layer (GCIPL) Thickness and Visual Field in Patients With a First Episode of Acute Optic Neuritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Optic Neuritis
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2016-10-20
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Optic neuritis typically occurs in young (mean age, 32 years), female (77%) patients, and it presents as subacute monocular visual loss that develops over several days.

As yet, treatment with intravenous corticosteroid for optic neuritis had no long-term beneficial effect on vision.

There are a number of factors that contribute to nerve fibre damage including increased level of sodium, so blocking sodium entry could help to protect them against damage.

The main objective of the study is determine whether phenytoin (which blocks sodium entry) can protect nerve fibre and improve final visual function after optic neuritis.


Eligibility criteria: Inclusion Criteria:

* isolated, unilateral, first acute optic neuritis (confirmed by neuroophthalmologist)
* willing to receive a steroidal regimen
* no pathologic finding in first oct
* no pathology and history of optic neuritis in contralateral eye
* \<14 days since onset visual loss

Exclusion Criteria:

* Contraindication or known allergy to Phenytoin
* Use of a calcium channel or sodium channel blocker in the past 2 months
* Corticosteroid use in the past 2 months
* Pregnancy
* Significant cardiac, renal or liver abnormalities
* Prior clinical episode of optic neuritis in either eye
* Bilateral acute optic neuritis
* Known ocular or neurological conditions or abnormalities other than refractive error that impair visual function
* Refractive error of greater than +5 or -5 diopters
* Any condition that may interfere with performance of Optical Coherence Tomography (OCT): corneal, lens or fundoscopic abnormality, a co-morbid ocular condition not related to optic neuritis as detected on the OCT reading

Primary outcomes:
measure: Retinal Ganglion Cell Inner Plexiform Layer Thickness
timeFrame: Measured at baseline and month 1, 6
measure: Macular Layer Thickness
timeFrame: Measured at baseline and month 1, 6
measure: Best Corrected Visual Acuity
timeFrame: at baseline and month 6
measure: Visual Field Mean Deviation in Decibel
timeFrame: Measured at baseline and month 6
Secondary outcomes:
measure: Retinal Nerve Fibre Layer Thickness in Micrometer
timeFrame: Measured at baseline and month1 ,6
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Eye Research Center Farabi Hosoital
Study officials:
References: