louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00850603: Safety and Immunogenicity of Intradermal Versus Subcutaneous Doses of Menomune®
Official title: Safety and Immunogenicity of Intradermal, and Low-dose Subcutaneous vs Subcutaneous Administration of Menomune® - A/C/Y/W-135
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Meningococcal Infections
Meningitis
Keywords: Menomune® - A/C/Y/W-135
Meningococcal Infections
Meningitis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-02-25
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of this trial is to study the administration of the Menomune vaccine given intradermally and low-dose subcutaneously versus standard subcutaneously. This study will describe the immunogenicity of Menomune® - A/C/Y/W-135 administered subcutaneously (standard dose) versus intradermally over a dose range (1/10th, 2/10th, and 3/10th of standard dose) and a low dose (2/10th of standard dose) subcutaneously.

The secondary objective is to describe the safety of the subcutaneous (SC) and intradermal (ID) routes at different dosages

Detailed description: This trial will provide a proof of concept that a dose range of Menomune given ID can induce an immune response that is comparable to standard dosing by the SC route, and is equivalent or superior to a low dose given SC.

Subjects will be randomized according to a computer-generated randomization schedule to receive the vaccine by SC injection or by ID injection at different dosages.

Eligibility criteria: Inclusion Criteria :

* 18 to 55 years of age.
* Willing to return for 3 follow-up visits and comply with a 30 day follow-up period.
* Signed an informed consent form.

Exclusion Criteria :

* Allergy to any component of the vaccine and latex.
* Known or suspected immunodeficiency or receipt of immunosuppressive therapy or blood products within the previous two months.
* History of serious chronic diseases (such as cardiac or renal disease).
* Acute febrile illness at the time of visit.
* Pregnancy.
* Receipt of any vaccine within the 28 days prior to enrollment.
* Receipt of meningococcal vaccine (example in Military) within the past 5 years or history of meningococcal disease.

Primary outcomes:
measure: Percentage of Participants With ≥ 4-Fold Rise in Antibody Titers
timeFrame: Baseline to 28 days post vaccination
measure: Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination.
timeFrame: Baseline (Day 0) and Day 28 post-vaccination
Secondary outcomes:
measure: Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination.
timeFrame: Day 0 to 7 days post-vaccination
Other outcomes:
Locations:
city: East Stroudsburg
country: United States
state: Pennsylvania
Study officials:
affiliation: Sanofi Pasteur Inc
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00192803: Non-Insulin Dependent Diabetes Mellitus (NIDDM) and Angiotensin Converting Enzyme 2 (ACE2): Diabetic Patients Treated With Antihypertensive Drugs
Official title: ACE/ACE2 Ratio in Diabetic Patients Treated With Antihypertensive Drugs
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: NIDDM
Keywords: niddm
ace2
NIDDM patients
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2005-09-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: ECT

Brief summary: This feasibility study is designed to examine modulation of the relative activities of ACE and ACE2 in diabetic patients following treatment with the angiotensin type 1 receptor (AT1R) antagonist, Candesartan.

This study will provide a closer insight to the possible involvement of the renin-angiotensin system (RAS)-related enzymatic components in development or attenuation of vascular pathogenesis.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Non-smokers
* Type II DM diagnosed patients
* Blood pressure \< 135/90
* Serum HbA1C \> 7%
* Serum creatinine \< 1mg%
* Urine microalbumin \< 300 mg/day
* Body mass index (BMI) \< 35 kg/m2

Exclusion Criteria:

* Insulin-dependent diabetic patients
* Patient with persistent microalbuminuria
* Patient with history of severe hypertension
* Congestive heart failure
* Patient receiving renin-angiotensin-aldosterone system (RAAS)-related anti-hypertensive medications.
* Patient with major hepatic disease

Primary outcomes:
measure: ACE and ACE2 activities in monocytes
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Internal Ward "A", Rambam Medical Center
Study officials:
affiliation: Rambam Health Care Campus
name: Shlomo Keidar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02534103: Relationship Between a Combined Index of Diastolic and Systolic Performance and Intraoperative Hemodynamic Changes During Off-pump Coronary Bypass Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Obstructive Disease
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-08-27
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with coronary artery obstructive disease planned to have multivessel OPCAB

Brief summary: As considering the close relationship between systolic dysfunction and diastolic dysfunction, the EAS index e'/(a' x s') including systolic and diastolic function could be expected to predict hemodynamic changes during off-pump coronary artery bypass surgery(OPCAB). Exposure of the grafting site during OPCAB needs displacement of the heart, resulting in hemodynamic instability.

Therefore the investigators are going to evaluate EAS index with preoperative Transthoracic echocardiography(TTE) and want to know the relationship between preoperative EAS index and intraoperative hemodynamic changes in patients undergoing OPCAB, in a prospective observational study.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 20
2. Patients undergoing multivessel off-pump coronary artery bypass surgery

Exclusion Criteria:

1. Age \< 20
2. Patients with valvular heart disease
3. Congestive heart failure, NYHA class ≥III
4. Emergency surgery
5. Patients with arrhythmia
6. ST segment elevation myocardial infarction

Primary outcomes:
measure: sequential changes of SvO2
timeFrame: during OPCAB surgery
measure: sequential changes of CI
timeFrame: during OPCAB surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anaesthesiology and Pain Medicine, Yonsei University College of Medicine
Study officials:
affiliation: Severance Hospital
name: Jae-Kwang Shim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01170403: Comprehensive Analyses of Multidetector-row Cardiac Computed Tomography Data in Koreans
Official title: Comprehensive Analyses of Multidetector-row Cardiac Computed Tomography Data of Over 15,000 Individuals in Korea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Disease
Keywords: coronary heart disease
Multidetector row cardiac computed tomography
type 2 diabetes
metabolic syndrome
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
Collaborators: name: The Korean Society of Lipidology and Atherosclerosis
First posted: 2010-07-27
Enrollment: 15000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Those who had undertook a computed tomographic angiography (CTA) with 64-slice MDCT from January 2nd 2006 until August 21st 2008. Reasons for exam include screening in asymptomatic subjects, diagnosis in patients with angina pectoris, follow up after percutaneous coronary intervention or coronary artery bypass grafting, differential diagnosis in chest pain and so on.

Brief summary: 64 channel multidetector-row Computed Tomography (CT) has been introduced for use in the diagnosis of coronary heart disease. The investigators aimed to characterize coronary artery disease in type 2 diabetes mellitus and metabolic syndrome, and in particular plaque natures depending on different status of metabolic diseases. The investigators also aimed to analyze the risk factors associated with number and severity of stenosis as well as plaque characteristics using logistic regression models.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years or older

Exclusion Criteria:

* pregnant women
* patients with chronic kidney disease (Cr\>2.0)

Primary outcomes:
measure: Cardiovascular event
timeFrame: five years
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Bundang-gu
Study officials:
References:
Clinical trial NCT03744403: A Study of CS1001 in Subjects with Advanced Solid Tumors
Official title: A Phase I, Open-Label, Multiple-Dose, Dose-Escalation Study of an Anti-PD-L1 Monoclonal Antibody CS1001 in Subjects with Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: CStone Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2018-11-16
Enrollment: 24
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: This is a phase I, open-label, multiple-dose, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of CS1001 in subjects with advanced solid tumors.


Eligibility criteria: Inclusion Criteria:

1. Subjects with metastatic or locally advanced unresectable solid tumor, who progressed following treatment with all available standard therapy, or for whom treatment is not available, not tolerated or refused.
2. ECOG performance status of 0 or 1.
3. Subjects must have at least one measurable lesion.
4. Patients with life expectancy ≥ 3 months.
5. Subject must have adequate organ function.
6. Fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for 180 days after last study drug administration.

Exclusion Criteria:

1. Known brain metastasis or other CNS metastasis that is either symptomatic or untreated.
2. Subjects with active autoimmune diseases or history of autoimmune diseases should be excluded.
3. Patients who have received prior therapies targeting PD-1, PD-L1, or CTLA-4.
4. Known history of HIV infection.
5. Subjects with active Hepatitis B or C infection.
6. Any unresolved CTCAE Grade ≥ 2 toxicities from prior anti-cancer therapy with the exception of vitiligo, alopecia.
7. Patients who have serious hypersensitive reaction to monoclonal antibodies, and have history of uncontrolled allergic asthma.
8. Known history of alcoholism or drugs abuse.
9. Subjects who received organ transplantation.
10. Known psychiatric disorders that would interfere with cooperation with the requirements of the trial.
11. Female subjects who are pregnant or breast-feeding; Male or female subjects of childbearing potential who refuse to use an effective method of birth control.

For more information regarding trial participation, please contact at cstonera@cstonepharma.com

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: From first dose to 90 days after last dose of CS1001, up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: NEXT Oncology
state: Texas
Study officials:
References:
Clinical trial NCT04017403: Probiotics Attenuate Postoperative Cognition Decline
Official title: Probiotics Oral Administration Attenuate Postoperative Cognition Decline in Elderly Orthopedic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Necrosis of Femoral Head
Knee Osteoarthritis
Fracture of Neck of Femur
Lumbar Disc Herniation
Keywords: postoperative cognitive dysfunction
postopeartive delirium
Probiotics
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2019-07-12
Enrollment: 220
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study was to evaluate whether perioperative probiotics can reduce the incidence of postoperative cognitive dysfunction and postoperative delirium.


Eligibility criteria: Inclusion Criteria:

1. . Age is greater than or equal to 65 years old
2. . Can communicate normally
3. . Selective knee ankle, hip replacement or lumbar open reduction and internal fixation under general anesthesia
4. . ASA graded at I-II level
5. . Patient or family informed consent

Exclusion Criteria:

1. . Have a brain disease, or have a history of brain disease
2. .MMSE check of less than 24 points.
3. . History of neurological and psychological disorders including AD, stroke, psychosis
4. . Serious hearing or visual impairment
5. . Preoperative systolic blood pressure \>190mmhg, or diastolic blood pressure \>100mmhg
6. . The patient or family refuses

Primary outcomes:
measure: Incidence of POCD 7days after surgery
timeFrame: The seventh day after surgery
Secondary outcomes:
measure: Incidence of POCD 1 month after operation
timeFrame: One month after surgery
measure: Incidence of POD 7 days after surgery
timeFrame: One day after surgery to the seventh day after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
state: Shanghai
city: Jincheng
country: China
facility: Jin Cheng people's hospital
state: Shanxi
Study officials:
affiliation: RenJi Hospital
name: su diansan
role: STUDY_CHAIR
References:
Clinical trial NCT02691403: Quadratus Lumborum Block for Postoperative Analgesia After Colostomy Closure
Official title: Ultrasound-guided Quadratus Lumborum Block for Postoperative Analgesia After Colostomy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postoperative Pain
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-02-25
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients undergoing abdominal procedures often require multimodal postoperative pain controls. Truncal blocks such as quadratus lumborum (QL) block may be used adjunctively as a part of it. The investigators hypothesized that the ultrasound-guided QL block with transmuscular approach can provide adequate pain relief for colostomy closure as part of a multimodal pain control.


Eligibility criteria: Inclusion Criteria:

* A physical status between ASA I and III
* 20 - 75 years of age
* Patient has signed an informed consent
* Without contraindication of QL block

Exclusion Criteria

* American Society of Anesthesiologists (ASA) Physical Status ≥ 4
* Any contraindication to nerve blocks (including coagulopathy, abnormal anatomy, infection at the planned QL injection site, and amide-type local anesthetic allergy) pregnancy or breast-feeding
* Severe obesity (body mass index≥ 35 kg/m2)
* Patients with a history of significant neurological, psychiatric, neuromuscular, cardiovascular, pulmonary, renal or hepatic disease
* Allergy to NSAIDs
* Infection at the QL injection site
* Patients with major psychosis or drug and alcohol abuse
* Patient unable to comprehend or use the verbal rating pain scoring system or patient-controlled analgesia pump

Primary outcomes:
measure: cumulative morphine consumption
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06009003: Individual Patient Esmethadone (REL-1017) Expanded Access Program
Official title: Individual Patient Esmethadone (REL-1017) Expanded Access Program
Study type: EXPANDED_ACCESS
Overall status: TEMPORARILY_NOT_AVAILABLE
Conditions: Major Depressive Disorder
Depression
Keywords: REL-1017
esmethadone
Relmada
antidepressant
NMDA receptor antagonist
Depression
Lead sponsor: Relmada Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Sponsor-Investigator
First posted: 2023-08-24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: To provide expanded access of esmethadone (REL-1017) to patients with a serious or immediately life-threatening disease or condition that may potentially benefit from esmethadone (REL-1017) who do not have access to other effective therapy and are not eligible for other clinical trials with esmethadone (REL-1017).

Detailed description: The Expanded Access Program (EAP) is intended to provide pre-approval access to esmethadone (REL-1017) for eligible patients who suffer from a serious or immediately life-threatening disease or condition that may potentially benefit from esmethadone (REL-1017) as determined by the treating physician and have no satisfactory treatment options. This program is open in the United States and operates under the Individual Patient (also referred to as Single Patient) IND expanded access route in which the patient's treating physician serves as the sponsor. Expanded access requests must be from the patient's treating physicians and submitted according to the Relmada EAP policy at https://www.relmada.com/our-portfolio/eap.

Eligibility criteria: Inclusion Criteria:

* Patients who may potentially benefit from treatment with esmethadone (REL-1017) as determined by the treating physician.
* Have undergone appropriate standard treatments without success and in the opinion of the treating physician no comparable or satisfactory alternative treatment is available to treat the disease or condition.
* Are ineligible or unable to participate in any ongoing clinical study of the investigational product.
* Condition for which, in the opinion of the treating physician, there is sufficient evidence of a potential benefit from the use of the investigational product, and that potential benefit outweighs the known or anticipated risks.

Exclusion Criteria:

* History or presence of clinically significant health conditions which in the opinion of the Investigator would negatively impact the safety of the participant.
* History of QTc prolongation.
* History of allergy or hypersensitivity to methadone or related drugs.
* Pregnant or planning to become pregnant.
* Breast-feeding or planning to breast-feed.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Relmada Therapeutics
name: Marco Pappagallo, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05206903: Emotional and Physical Health Status of Adults
Official title: Emotional and Physical Health Status of Adults in Pandemia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pandemic, COVID-19
Adult ALL
Keywords: Pandemia awareness
General fatique
Quality of life
Sleep quality
Bodily pain
Status of physical activity
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2022-01-25
Enrollment: 250
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults between the ages of 20-60 years.

Brief summary: To investigate the comparison of differences between emotional and physical health status of adults in COVID-19 isolation period and controlled normalization period.


Eligibility criteria: Inclusion Criteria:

* To speak Turkish
* Living in Turkey in pandemic process.
* Between the ages of 20-60 years.
* No communication problems.
* Being volunteer to participate in study.

Exclusion Criteria:

* Having communication problems.
* Not completion the assessments.

Primary outcomes:
measure: Pandemic Awareness Scale
timeFrame: 1 minute
measure: Chalder Fatigue Scale
timeFrame: 2 minutes
measure: Pittsburgh Sleep Quality Index
timeFrame: 3 minutes
measure: EQ-5D Health-Related Quality of Life Questionnaire
timeFrame: 1 minute
measure: Physical Activity Score
timeFrame: 1 minute
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01321203: Outcome of Carbon Dioxide Versus Air Insufflations During Endoscopic Retrograde Cholangiopancreatography (ERCP)
Official title: A Double-blind, Randomized, Controlled Trial of Air Insufflation Versus Carbon Dioxide Insufflation During Endoscopic Retrograde Cholangiopancreatography (ERCP).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Jaundice
Keywords: carbon dioxide insufflation
Lead sponsor: Asian Institute of Gastroenterology, India
Sponsor class: OTHER
First posted: 2011-03-23
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population age group 18yrs and above

Brief summary: To assess the safety and efficacy of CO2 insufflations during ERCP

1. Primary objective:

   To assess the patient's symptoms, abdominal pain and abdominal distension post procedure (ERCP) in the study group.
2. Secondary objective:

Endoscopist:

* To assess the adequacy of bowel distension for adequate luminal visualization
* To assess the peristaltic movement during the ERCP

Anesthetist:

* To measure the PCO2 level in patient post procedure.
* To assess the amount of sedation required during the procedure.
* To assess saturation and vital signs through out the procedure.
* To assess requirement of buscopan.

Detailed description: mentioned in complete

Eligibility criteria: Inclusion Criteria:

* All consecutive adult patients referred for ERCP to AIG Hyderabad

Exclusion Criteria:

* Age \< 18 years old excluded from the study.
* Patients with COPD.
* Patients with poor ejection fractions and decompensated heart failure.
* Patients with acute illness that require emergency ERCP and not fit for pre procedure and post procedure assessments.
* Patients with recent endoscopic procedure within 24 hours.
* Patient with history of recent surgery within 7 days of duration.
* Pregnant patients.
* Patients not keen to give consent for the study.

Primary outcomes:
measure: Patient comfort post ERCP
timeFrame: 1 hour
Secondary outcomes:
measure: Abdominal distention prior and post ERCP
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Asian Institute Of Gastroenterology India
state: Andra Pradesh
Study officials:
affiliation: Asian Institute of Gastroenterology, India
name: Saravanan Arjuanan, MD
role: PRINCIPAL_INVESTIGATOR
References: