louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05075239: Morbidity and Mortality in Solo Adult Traumatic Brain Injury Patients in Minia University Hospital
Official title: Incidence Of Morbidity And Mortality After Isolated Traumatic Brain Injury In Adult Neuro-intensive Care Unit In Minia University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Statistical Analysis of Traumatic Brain Injury Victims
Keywords: neurotrauma
traumatic brain injury
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2021-10-12
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: both sexes with individual neurotrauma

Brief summary: Tracking post-traumatic brain injury sequale


Eligibility criteria: Inclusion Criteria:

* Solo non penetrating neurotrauma victims

Exclusion Criteria:

* 1- Penetrating head trauma. 2- Polytrauma patients. 3- Coexist of Psychiatric disorders or history of neuronal disorders. 4- Refusal of patient relatives to participate in the assignment. 5- Pregnant females with TBI. 6- Patients who died during 24 hours from admission to ICU . 7- Patients more than 65 years of age .

  8- combined abdominal or orthopedic trauma.

Primary outcomes:
measure: mortality and morbidity
timeFrame: 4 weeks
Secondary outcomes:
measure: prediction
timeFrame: one week
Other outcomes:
Locations:
city: Minia
country: Egypt
facility: Maher Maher
Study officials:
References:
Clinical trial NCT04148339: A Pilot Study to Explore the Role of Gut Flora in Elevated Cholesterol
Official title: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Elevated Cholesterol
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cholesterol, Elevated
Elevated Cholesterol
Lead sponsor: ProgenaBiome
Sponsor class: OTHER
First posted: 2019-11-01
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have been diagnosed with elevated cholesterol

Brief summary: This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding Elevated Cholesterol.

Detailed description: The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding Elevated Cholesterol.

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study
2. Male or female patients of any age (interest is given to children to compare with mothers).
3. LDL\>100
4. Total Cholesterol\>200

Exclusion Criteria:

1. Refusal to sign informed consent form
2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
3. Postoperative stoma, ostomy, or ileoanal pouch
4. Participation in any experimental drug protocol within the past 12 weeks
5. Treatment with total parenteral nutrition
6. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
7. Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study

Primary outcomes:
measure: Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing
timeFrame: One year
Secondary outcomes:
measure: Validation of Sequencing Methods
timeFrame: One year
Other outcomes:
Locations:
city: Ventura
country: United States
facility: ProgenaBiome
state: California
Study officials:
affiliation: ProgenaBiome
name: Sabine Hazan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00642239: A Clinical Trial of a Radiation Sensitizer in Radiochemotherapy for Thoracic Esophageal Squamous Carcinoma
Official title: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial of Sodium Glycididazole in Concurrent Radiochemotherapy for the Treatment of Thoracic Esophageal Squamous Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Esophageal Carcinoma
Keywords: Sodium Glycididazole, Radiochemotherapy, Esophageal Carcinoma
Lead sponsor: Shandong Luye Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2008-03-25
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This multicentered clinical trial is going to find out the radio-sensitization action of sodium glycididazole in radiochemotherapy for esophageal cancer.

Detailed description: Esophageal cancer is one of the most frequent causes of cancer death in the world. The most common type of esophageal cancer is squamous cell carcinoma (SCC) in China. Although concurrent radiochemotherapy is recommended as the standard treatment for advanced esophageal carcinoma, the local failure still reaches up to 44%-54%.

Sodium Glycididazole(CMNa) is a radiosensitive drug for hypoxic tumor cells. Clinical trials showed that CMNa can improve local control rate and survival rate of esophageal cancer. This study is going to confirm the efficacy and safety of CMNa in concurrent radiochemotherapy of radiotherapy and 5-FU+DDP for esophageal squamous carcinoma.

Eligibility criteria: Inclusion Criteria:

* written informed consent
* photographically and histologically proven thoracic esophageal squamous carcinoma
* stages 2a-3, and stage 4 with only supraclavicular lymph nodes metastasis defined by AJCC(2002)
* radiochemotherapy indication
* measurable tumor
* adequate hematologic, hepatic and renal function
* Karnofsky performance status ≥70
* age more than 18years and less than 70 years

Exclusion Criteria:

* pregnancy and lactation
* significant neurologic disease
* severe liver and renal malfunction,and Significant medical illness
* previous chemotherapy, radiotherapy or immunotherapy
* esophagus hemorrhage and esophagus perforation features

Primary outcomes:
measure: tumour local control rate
timeFrame: 6 weeks
Secondary outcomes:
measure: survival rate
timeFrame: one year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Guangzhou
country: China
facility: Cancer Center of Sun Yat-sen University
state: Guangdong
city: Shanghai
country: China
facility: Zhongshan Hospital of Fudan University
state: Shanghai
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
Study officials:
affiliation: Cancer Hospital, Chinese Academy of Medical Science
name: Lvhua Wang, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04222439: Deep Learning Algorithm for the Diagnosis of Gastrointestinal Diseases
Official title: Development and Validation of a Deep Learning Algorithm for the Diagnosis of Gastrointestinal Diseases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastrointestinal Disease
Keywords: Deep Learning
Central Neural Networks
Endoscopy
Gastrointestinal Disease
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2020-01-10
Enrollment: 100000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to develop and validate a deep learning algorithm for the diagnosis of gastrointestinal diseases. Then, evaluate the accuracy this new artificial intelligence(AI) assisted recognition system in clinic practice.

Detailed description: Recently, deep learning algorithm based on central neural networks (CNN) has shown multiple potential in computer-aided detection and computer-aided diagnose of gastrointestinal lesions. However, there is still a blank in recognition of all gastrointestinal diseases. This study aim to develop and validate a deep learning algorithm for the diagnosis of gastrointestinal diseases. Then, evaluate the accuracy this new artificial intelligence(AI) assisted recognition system in clinic practice.

Eligibility criteria: Inclusion Criteria:

* Participants, aged 18 years or older, who had not had a previous endoscopy were retrieved from all participating hospitals.

Exclusion Criteria:

-

Primary outcomes:
measure: The diagnostic accuracy of gastrointestinal diseases with deep learning algorithm.
timeFrame: 1 month
Secondary outcomes:
measure: The diagnostic sensitivity of gastrointestinal diseases with deep learning algorithm.
timeFrame: 1 month
measure: The diagnostic specificity of gastrointestinal diseases with deep learning algorithm.
timeFrame: 1 month
measure: The diagnostic positive predictive value of gastrointestinal diseases with deep learning algorithm.
timeFrame: 1 month
measure: The diagnostic negative predictive value of gastrointestinal diseases with deep learning algorithm.
timeFrame: 1month
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Xiuli Zuo, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00364039: Study to Examine the Safety, Tolerability, and Pharmacokinetics of AV650
Official title: A Phase 1 Double-Blind, Placebo-Controlled Single Center Trial to Assess the Safety, Tolerability and Pharmacokinetics of Single Dose and Multiple Dose Escalations of AV650 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Avigen
Sponsor class: INDUSTRY
First posted: 2006-08-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine the safety and tolerability of AV650 in healthy subjects given single and multi-doses under fasted and fed conditions.


Eligibility criteria: Inclusion Criteria:

* Non-smoking
* Body mass index between 18.5 and 29.9 kg/m2 or body mass index greater than 29.9 kg/m2 with good to excellent body fat percentage

Exclusion Criteria:

* Known hypersensitivity to lidocaine or non-steroidal anti-inflammatory agents (NSAIDS)
* History of clinically significant cardiovascular, pulmonary, endocrine, neurological, metabolic, or psychiatric disease
* History of HIV or Hepatitis B
* History of symptomatic hypotension
* History of mental illness, drug addiction, drug abuse or alcoholism
* History of cancer
* History of inflammatory arthritis (rheumatoid, lupus, psoriatic arthritis)
* Current use of immunosuppressive therapy (systemic steroids, cyclosporine) or use of nasal or topical steroids
* History of gastric or duodenal ulcer disease
* History of severe physical injury, direct impact trauma or neurological trauma within 6 months of Study Day 1
* Female subjects who are pregnant or nursing
* Have donated blood within 90 days of Study Day -1
* Have received an investigational drug within 90 days of Screening
* Require regular use of antihistamines, H2 blockers (such as cimetidine, ranitidine), TCAs or SSRIs or who have taken these medications witin 14 days of Study Day 1

Primary outcomes:
measure: Safety
measure: Tolerability
Secondary outcomes:
measure: Pharmacokinetic profile
measure: Sedation and reaction time changes
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: SNBL Clinical Pharmacology Center
state: Maryland
Study officials:
affiliation: SNBL Clinical Pharmacology Center
name: Stephan A. Bart, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03251339: Safety and Immunogenicity of MSB11455 in Healthy Participants
Official title: A Randomized, Double-blind, Parallel Group,Controlled Study to Compare the Immunogenicity and Safety of MSB11455 and Neulasta® in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy Participants
MSB11455
Lead sponsor: Fresenius Kabi SwissBioSim GmbH
Sponsor class: INDUSTRY
First posted: 2017-08-16
Enrollment: 336
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The primary purpose of this study is to compare the immunogenicity and safety of MSB11455 and Neulasta in healthy adult participants.


Eligibility criteria: Inclusion Criteria:

* Participants who provide signed and dated written informed consent.
* Participants with laboratory test results within predefined ranges.
* Other protocol defined inclusion criteria could apply.

Exclusion Criteria:

* Participants with known hypersensitivity to any component of US-Neulasta or MSB11455.
* Other protocol defined exclusion criteria could apply.

Primary outcomes:
measure: To Assess the Immunogenicity of MSB11455 Compared to Neulasta
timeFrame: From first dose up to end of study (Up to 3 months)
Secondary outcomes:
measure: Safety Profile as Assessed by Clinical Adverse events (AEs), Laboratory Variables, Vital Signs, Incidence of Antidrug Antibodies (ADAs), Neutralizing Antibodies(NABs)
timeFrame: Day 1 up to a maximum of 1 year
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: Auckland Clinical Studies Ltd
city: Christchurch
country: New Zealand
facility: Christchurch Clinical Studies Trust
Study officials:
affiliation: Fresenius Kabi SwissBioSim
name: Radmila Kanceva, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06853639: Analysis of Oral Health of Students and Former Students of Undergraduate and Postgraduate Programs at the University of São Paulo.
Official title: Analysis of Oral Health of Students and Former Students of Undergraduate and Postgraduate Programs at the University of São Paulo: A Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Oral Health
Keywords: oral health
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2025-03-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Undergraduate and graduate students at the University of São Paulo

Brief summary: This study aims to evaluate oral and systemic health conditions among students and former students of undergraduate and postgraduate programs at the University of São Paulo over five years. The primary focus is to understand how oral health impacts academic performance and attendance, providing insights for health promotion strategies within the university community.

Detailed description: The study employs a prospective cohort design to explore multiple health-related outcomes, including periodontal health, oral health literacy, and the prevalence of caries. The data collected will also examine social and behavioral predictors of oral health, such as dietary habits, stress, and use of substances like tobacco and electronic cigarettes.

Eligibility criteria: Inclusion Criteria:

* 1. Current and former undergraduate and postgraduate students of the University of São Paulo.

Exclusion Criteria:

* 1. Individuals who do not consent to participate.

Primary outcomes:
measure: Plaque index
timeFrame: through study completion, an average of 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Faculdade de Odontologia da USP
Study officials:
affiliation: University of Sao Paulo
name: Giuseppe A Romito
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00292539: Prospective Registry of Pacemaker Patients Concerning Percentage of Right Ventricular Pacing, LVEF and NYHA Class
Official title: Preserve Registry: Prospective Registry of Pacemaker Patients Concerning Percentage of Right Ventricular Pacing, LVEF and NYHA Class
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Bradycardia
Heart Block
Sick Sinus Syndrome
Keywords: Pacemaker
NYHA class
Ejection fraction
Heart Failure
Lead sponsor: Guidant Corporation
Sponsor class: INDUSTRY
First posted: 2006-02-16
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE

Brief summary: This registry is a data collection on patients who are implanted for more than 6 months with a pacemaker. Frequency and distribution of right ventricular pacing, NYHA class and left ventricular ejection fraction shall be documented.


Eligibility criteria: Inclusion Criteria:

* Implanted pacemaker for more than 6 months, VVI/DDD, written consent

Exclusion Criteria:

* Pacemaker implanted for less than 6 months, no right ventricular pacing possibility (AAI), no consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Viechtach
country: Germany
facility: Kreiskrankenhaus
Study officials:
affiliation: Guidant Corporation
name: Sven Treusch, PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04013139: Relationship Between Cardiopulmonary Exercise Testing and Ca-P in Chronic Kidney Disease (CKD)
Official title: Evaluation of the Relationship Between Cardiopulmonary Exercise Testing (CPET ) Abnormalities and Ca-P Status in CKD Stage3-5
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ckd-Mbd
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2019-07-09
Enrollment: 200
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: All \>18 years CKD Patients with GFR \<60 non-dialysis

Brief summary: Reductions in exercise capacity associated with exercise intolerance augment cardiovascular disease risk and predict mortality in chronic kidney disease. This study utilized cardiopulmonary exercise testing to (a) investigate mechanisms of exercise intolerance; (b) unmask subclinical ca and p and vitamin D abnormalities that may precede cardiovascular disease in chronic kidney disease.

Detailed description: Cardiopulmonary exercise testing will carry out in Stage 3-5 chronic kidney disease patients ; estimated glomerular filtration rate \<60 ml/min/1.73 m2) and biochemistry will be added (Ca P Via D PTH FGF23).

Eligibility criteria: Inclusion Criteria:

* CKD Patients with GFR \<60 non-dialysis
* age\<18

Exclusion Criteria:

* HTN
* not signing consent
* active coronary disease

Primary outcomes:
measure: Calcium x phosphorus change in stage 3-5
timeFrame: 12 MONTHS
measure: CPET score change
timeFrame: 12 MONTHS
Secondary outcomes:
measure: Renal Function change
timeFrame: 12 MONTHS
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Nooshin Dalili
Study officials:
affiliation: SBMU
name: Dalili
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01025986: Uveitis in Relation to Perceived Stress: A Prospective Study
Official title: Uveitis in Relation to Perceived Stress: A Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Uveitis
Lead sponsor: The New York Eye & Ear Infirmary
Sponsor class: OTHER
First posted: 2009-12-04
Enrollment: 200
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: Patients presenting at the New York Eye and Ear Infirmary diagnosed with uveitis

Brief summary: The purpose of this study is to conduct a prospective analysis to determine the relationship between disease activity of noninfectious uveitis and stress.

Detailed description: Patients presenting at The New York Eye and Ear Infirmary (NYEEI) who meet the inclusion criteria will be recruited prospectively. Patients diagnosed with non-infectious uveitis will be asked to self-administer the Perceived Stress Scale (PSS) - 10, following informed consent. Patient demographics will also be collected. The presence of inflammation will be then be assessed by the investigator. Patients will be asked to complete the PSS-10 again at all subsequent standard-of-care visits within a 6-month timeframe. PSS-10 scores are obtained by reversing the scores on the four positive items (4, 5, 7 and 8), then summing across all 10 items. Patient and the investigator will be masked to the PSS scores.

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age with a diagnosis of non-infectious uveitis
* Able to self-administer the Perceived Stress Scale (PSS) - 10

Exclusion Criteria:

* Diagnosis of infectious uveitis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: The New York Eye and Ear Infirmary
state: New York
Study officials:
References:
Clinical trial NCT02390986: An Extension Study of LON002 in Patients With Cancer
Official title: An Extension Study of LON002 in Patients With Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Solid Tumours
Keywords: Cancer
Malignant Neoplasm
Anti-cancer drug
Lead sponsor: LondonPharma Ltd.
Sponsor class: INDUSTRY
First posted: 2015-03-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical trial is to evaluate the long term safety and efficacy of LON002.

Detailed description: This is an extension study of LON002 in patients with cancer, who have completed other London Pharma sponsored LON002 studies (parent study). It provides the opportunity for patients to continue receiving treatment for as long as the patient continues to derive a clinical benefit.

Long term safety and efficacy will be evaluated.

Eligibility criteria: Inclusion Criteria:

1. Written informed consent;
2. Has completed a LondonPharma sponsored parent trial of LON002 and continues to have clinical benefit in the judgement of the investigator;
3. Eligible for continuation of LON002 treatment at the end of the parent trial, according to the parent trial protocol;
4. Able to comply with the protocol LON002-003;
5. Women of child bearing potential must have a negative pregnancy test before the start of treatment;
6. Sexually active women of childbearing potential must be using an acceptable form of contraception for the duration of dosing and for 30 days thereafter;
7. Male subjects with female partners of childbearing potential should use condoms for the duration of dosing and for 30 days thereafter

Exclusion Criteria:

1. Has not completed a LondonPharma sponsored parent trial of LON002;
2. Unequivocal evidence of disease progression;
3. Unacceptable toxicity experienced in the parent trial;

Primary outcomes:
measure: Proportion of patients with Adverse Events grade ≥3 related to LON002 and Serious Adverse Events related to LON002 as a measure of safety and tolerability.
timeFrame: Participants will be followed for the duration of their study treatment, an expected average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guildford
country: United Kingdom
facility: The Royal Surrey County Hospital
state: Surrey
city: London
country: United Kingdom
facility: Guy's and St Thomas NHS Foundation Trust
Study officials:
affiliation: Guy's and St Thomas' NHS Foundation Trust
name: Debashis Sarker, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Surrey County Hospital NHS Trust
name: Mazhar Ajaz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Xidea Solutions Ltd
name: Daryl Bendel, MD
role: STUDY_DIRECTOR
References: