louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05153850: Assessment of the Response to the Complete Vaccination Guidelines Against Sars-cov2
Official title: Assessment of the Response to the Complete Vaccination Guidelines Against Sars-cov2 in Patients With Inflammatory Bowel Disease Under Inmunosuppressor Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
First posted: 2021-12-10
Enrollment: 243
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients included in the study are elderly patients suffering from inflammatory bowel disease and have completed their vaccination schedule against the SARS-COV-2 virus.

Brief summary: Prospective observational single-center study in which the impact of anti-TNF biological treatment on the humoral response after complete vaccination against SARS-COV2 in patients with inflammatory bowel disease is analyzed.

Detailed description: Prospective observational single-center study in which the impact of anti-TNF biological treatment on the humoral response after complete vaccination against SARS-COV2 in patients with inflammatory bowel disease is analyzed.

The first objective is to compare the seroconversion rate after full vaccination against SARS-COV2 in patients with IBD treated with anti-TNF drugs versus patients treated with Ustekinumab / Vedolizumab and patients without immunosuppressive treatment.

The Patients included in the study belong to the health area of the Virgen Macarena University Hospital who meet the following inclusion criteria and none for exclusion.

Eligibility criteria: Inclusion Criteria:

* Be of legal age (\> 18 years).
* Diagnosis of inflammatory bowel disease (Crohn's Disease or Ulcerative Colitis).
* Complete vaccination schedule (one or two doses depending on previous SARS-Cov2 infection) between one and four months prior to the determination of anti-SARS-Cov2 antibodies.
* Treatment with biological therapy for at least 6 weeks prior to the time of vaccination for the group of patients treated with biological drugs.

Exclusion Criteria:

* Last vaccination dose more than four months ago from the determination of antibodies against SARS-Cov2.

Primary outcomes:
measure: Number of patients with peripheral blood antibodies against SARS-COV2.
timeFrame: Up to 16 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
state: Andalucía
Study officials:
affiliation: Hospital Universitario Virgen Macarena
name: Federico Argüelles Arias
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05177250: Association of Bisphenol A,Paraben Exposure and Type 2 Diabetes
Official title: The Possible Association Between Bisphenol A, Paraben Exposure and Type 2 Diabetic Adult Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type2 Diabetes
Bisphenol A
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-01-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The aim of this study is to evaluate the association between BPA , paraben levels and type 2 DM patients

Detailed description: The first phase of the study will include a questionnaire :

* The cases and control will be asked about demographic information such as residence, age, education, and occupation.
* History of discovery of diabetes.
* Exposure to products and materials such as polycarbonate plastics, cosmetics and beverages containing bisphenol A and paraben and it will be evaluated through exposure sheet through asking about dietary exposure, Environmental exposure and medical exposure.

Then clinical evaluation including:

* Full clinical examination will be performed for cases and control.
* Anthropological data:

their weights, heights and waist circumference will be measured. The body mass index (BMI) will be calculated by weight (kg)/height (m)2 formula.

* Investigations: routine and specific investigation as blood glucose level, HbA1c and lipid profile.
* Urine specimens will be collected in clean, glass containers will labeled with the subject identification number. Turbid sample or those containing blood will be excluded.
* All specimens will be stored frozen below 20 degree centigrade.
* Urine samples will be analyzed by High Performance liquid chromatograph (HPLC) to detect bispenol A and parabens levels.

Eligibility criteria: Inclusion Criteria:

1. Adult patients ( 18 y or elder).
2. Type 2 DM

Exclusion Criteria:

* Type 1 DM
* Less than 18 y
* History of chronic diseases such as liver failure, cardiac patients......etc

Primary outcomes:
measure: Bisphenol A and paraben detection in urine samples of diabetic (n=50) and non diabetic persons (n=50)
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ahmed Fathy
Study officials:
References:
Clinical trial NCT06685250: Postoperative Pain After a Laparoscopic Cholecystectomy
Official title: Randomized Controlled Trial Comparing Low (8 MmHg) Vs. Standard (14 MmHg) CO2 Insufflation Pressure on Postoperative Pain in Patients Undergoing Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Hopital Charles Nicolle
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Randomized Controlled Trial to compare the effect of low (8 mmHg) versus Standard (14 mmHg) insufflation pressure of CO2 pneumoperitoneum on postoperative pain in patients undergoing laparoscopic cholecystectomy


Eligibility criteria: Inclusion Criteria:

* ASA 1 or ASA 2
* uncomplicated symptomatic gallblader lithiasis scheduled for elective surgery
* no choledocholithiasis
* no associated surgical procedures
* no cerebrovasculare accident with neurological sequelae or other neurological disorders that affects sensation of pain
* no ascites
* no carcinomatosis

Exclusion Criteria:

* conversion to laparotomy
* need to keep an escat drain

Primary outcomes:
measure: Postoperative pain
timeFrame: Hour 6
Secondary outcomes:
measure: postoperative pain
timeFrame: Hour 12
measure: Postoperative pain
timeFrame: Hour 24
measure: vommiting (PONV score)
timeFrame: from 0 to 24 hours after surgery
measure: morbidity
timeFrame: 30 days
measure: postoperative length of stay
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00590850: Non-Operative Versus Operative Treatment for High-Energy Midshaft Clavicle Fractures
Official title: A Multicenter, Prospective, Randomized Trial of Non-Operative Versus Operative Treatment for High-Energy Midshaft Clavicle Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Energy Midshaft Clavicle Fractures
Lead sponsor: Prisma Health-Upstate
Sponsor class: OTHER
Collaborators: name: Orthopaedic Trauma Association
name: Indiana University
First posted: 2008-01-11
Enrollment: 412
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clavicle (collar bone) fractures account for about 33% of all fractures around the shoulder. Some surgeons suggest that surgical treatment is the best option, while others suggest that nonoperative care is the best treatment. There is no evidence to date that either option in superior. For this reason, we propose to conduct a prospective, randomized clinical trial of surgical versus non-surgical treatment of displaced high-energy clavicle fractures. This study will use both objective clinical and patient-based outcome measures. The purpose of this study is to see if there is a difference between clinical outcomes (healing rate, time to healing, time to return to work, Constant Score, complications), functional outcomes (DASH Score), and health related quality of life (SF-36) in nonoperative care and two types of surgical care for displaced fractures of the clavicular shaft in adults.

Included patients will be randomized into one of three groups: nonoperative care (Group N); surgical care using plates and screws (Group P); and surgical care using intramedullary pin put inside of the clavicle to stabilize it (Group I).


Eligibility criteria: Inclusion Criteria:

* ages of 18 and 85
* a midshaft clavicle fracture
* fracture displaced the width of the clavicle or shortened at least 1.5 cm
* less than 21 days since the injury

Exclusion Criteria:

* injury involving the lateral ligaments
* fracture involve the sternoclavicular joint
* Pathologic Fracture
* Open Fracture
* Fracture with neurovascular compromise
* Displaced fracture with impending skin compromise
* Medical comorbidities that preclude surgery
* Associated injuries to ipsilateral shoulder girdle
* severe cognitive disability or injury that may inhibit study form completion

Primary outcomes:
measure: Disability of Arm, Shoulder and Hand (DASH) scores
timeFrame: 1 year
Secondary outcomes:
measure: Reoperation rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Prisma Health
state: South Carolina
Study officials:
affiliation: Greenville Hospital System
name: Kyle J Jeray, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03137550: Combined Use of Multiple Biomarkers With Stress Testing to Detect Coronary Artery Disease
Official title: Combined Use of Multiple Biomarkers With Stress Testing to Detect Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2017-05-02
Enrollment: 850
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Eligible are all patients who receive stress testing ordered by a physician of the University Heart Center and who are willing and able to participate in an observational study. Participants of interest are outpatients and inpatients of the University Heart Centre.

Brief summary: Main aim of the COMBAT-CAD-Study is to clarify, if the combination of stress testing with biomarkers improves the diagnostic accuracy.

Hypothesis of our study is that diagnosis of CAD can be improved by adding biomarkers to solely stress testing for the workup of patients with suspected CAD or progress of already known CAD.

Detailed description: The COMBAT-CAD Study is an observational study with the aim to improve the diagnostic accuracy by a combination of stress testing with sensitive and specific biomarkers in detecting coronary artery disease or its progress. The main subjects are all patients with CAD or suspicion of CAD sent to the University Heart Center Hamburg. In these patients, ECG, laboratory examination, symptoms or transthoracic echocardiography in rest could not rule out CAD or progress of known CAD. The hypothesis of the study is that detection of CAD can be improved by adding biomarkers to stress testing for the diagnostic workup of patients with suspected CAD or progress of already known CAD.

Eligibility criteria: Inclusion Criteria:

1. Every patient referred to coronary angiography, or diagnostic work-up with suspicion of CAD or progress of CAD (in case of CABG patients or already treated with PCI)

Exclusion Criteria:

1. Insufficient knowledge of the German language (able to understand and write the German language)
2. Physical or psychological incapability to take part in the investigation
3. Persons with no sufficient language ability in German to understand the provided study information material.

Primary outcomes:
measure: Diagnosis of coronary artery disease
timeFrame: Within the initial diagnostic evaluation process (maximum within 30 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Department of General and Interventional Cardiology, University Heart Center Hamburg
Study officials:
affiliation: Head of the Department
name: Stefan Blankenberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02626650: Recent Experiences With Concussions
Official title: Recent Experiences and Presentation Format: Study of Concussion Symptom Elicitation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Concussion
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Carnegie Mellon University
name: University of Oklahoma
First posted: 2015-12-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: College athletes will be recruited to complete a voluntary online survey that will take approximately 10 minutes. In this survey, they will answer a series of questions related to the concussion symptoms they have experienced in their recent sports season, their opinions related to concussions and concussion treatment, and demographics.

Detailed description: College athletes will be recruited to complete a voluntary online survey that will take approximately 10 minutes. In this survey, they will answer a series of questions related to the concussion symptoms they have experienced in their recent sports season, their opinions related to concussions and concussion treatment, and demographics.

Of interest, participants will indicate what concussion symptoms they have recently experienced in one of four formats, to which they will be randomly assigned. Participants will either \*check the symptoms they have experienced, \*check the symptoms they have not experienced, \*uncheck the symptoms they have experienced, or \*uncheck the symptoms they have not experienced. It is believed that an alternative method of reporting symptoms that requires participants to indicate the symptoms they have not experienced will lead them to report having experienced a greater number of symptoms, based on past research regarding inclusion vs. exclusion modes of thought.

Eligibility criteria: Inclusion Criteria:

* Collegiate athlete (identified by staff at each cooperating institution)

Exclusion Criteria:

* Under age of 18

Primary outcomes:
measure: Number of symptoms
timeFrame: Through survey completion, an average of 12 minutes
Secondary outcomes:
measure: Perceived risk of concussions
timeFrame: Through survey completion, an average of 12 minutes
measure: Concern about concussions
timeFrame: Through survey completion, an average of 12 minutes
measure: Concern about concussions for health
timeFrame: Through survey completion, an average of 12 minutes
measure: Beliefs about responses to concussions
timeFrame: Through survey completion, an average of 12 minutes
measure: Estimated number of concussions
timeFrame: Through survey completion, an average of 12 minutes
measure: Knowledge about concussions
timeFrame: Through survey completion, an average of 12 minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06293950: Allogeneic Wharton Jelly Mesenchymal Stromal Cell (WJMSC) for Treatment of Autism
Official title: Allogeneic Wharton Jelly Mesenchymal Stromal Cell (WJMSC) for Treatment of Autism
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Autism
Keywords: autism
WJMSC
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 14
Sex: ALL
Minimum age (years): 4
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Autism spectrum disorders (ASDs) are characterized by core domains: persistent deficits in social communication and interaction; restricted, repetitive patterns of behavior, interests, or activities.

Detailed description: Autism spectrum disorders (ASDs) are characterized by core domains: persistent deficits in social communication and interaction; restricted, repetitive patterns of behavior, interests, or activities. ASDs comprise heterogeneous and complex neuro-developmental pathologies with well-defined inflammatory conditions and immune system dysfunction. Due to neurobiological changes underlying ASD development, cell-based therapies have been proposed and applied to ASDs. Indeed, stem cells show specific immunologic properties, which make them promising candidates for ASD treatment.

Eligibility criteria: Inclusion Criteria:

* 14 subjects, 4-14 years of age, will be enrolled into this study, who meet the criteria for (ASD

Exclusion Criteria:

* Age \> 14 years.
* Patient weighing \< 10 kg.
* History of severe Allergy
* History of severe head trauma, defined by loss of consciousness or hospitalization, skull fracture, or stroke.
* Seizure within the last year before enrollment, or the need for seizure medications either at present or in the past.
* Evidence or history of severe, moderate, or uncontrolled systemic disease.
* Inability to follow the prescribed dosing and follow-up schedule.
* Use of any stimulant or non-stimulant medication or medications given for attention deficit hyperactivity disorder (ADHD) must be discontinued 7 days before the initial randomized study period.
* Subjects taking a selective serotonin reuptake inhibitor (SSRI) must be on a stable dose for a minimum of 30 days before entering the study.
* History of premature birth \<35 weeks' gestation.
* Prior history of stroke in utero or other in utero insult.

Primary outcomes:
measure: safety profile lab tests
timeFrame: follow-up duration is 12 months
Secondary outcomes:
measure: efficacy change in Adult ADHD Self-Report Scale (ASRS)
timeFrame: follow-up duration is 12 months
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Cell Therapy Center
Study officials:
affiliation: Cell Therapy Center
name: Abdallah Awidi, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06897150: Carotegrast Methyl in Ulcerative Colitis
Official title: Efficacy and Safety of Carotegrast Methyl in Active Ulcerative Colitis: A Real-World Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ulcerative Colitis
Lead sponsor: Yokkaichi Hazu Medical Center
Sponsor class: OTHER
First posted: 2025-03-26
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Carotegrast methyl, an oral α4-integrin inhibitor, was recently approved in Japan for the treatment of active ulcerative colitis (UC). However, real-world data regarding its efficacy and safety remain scarce. This study aimed to assess the clinical effectiveness and safety profile of carotegrast methyl in patients with active UC.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with UC based on endoscopic and histological findings
* Patients with clinically and endoscopically moderate UC who were eligible for outpatient treatment (however, patients in clinical remission or with mild clinical activity but endoscopically moderate UC were also considered eligible as an exception)
* Patients who exhibited an inadequate response to or intolerance of 5-ASA formulations (including topical agents) or budesonide formulations (including topical agents)
* Patients who provided informed consent for endoscopic examinations at the start of treatment and during the treatment period
* Patients who agreed to blood sampling and fecal biomarker tests

Exclusion Criteria:

* Patients with severe disease on endoscopy (presumed ineffective due to the drug's characteristics)
* Patients currently using biologics, JAK inhibitors, thiopurines, or calcineurin inhibitors (tacrolimus or cyclosporine)
* Patients with a history of malignancy
* Patients with severe hepatic dysfunction
* Pregnant women or those planning pregnancy
* Patients with acute severe conditions, such as toxic megacolon, sepsis, peritonitis, or infectious colitis

Primary outcomes:
measure: Clinical remission
timeFrame: Week 8
Secondary outcomes:
measure: Endoscopic remission
timeFrame: Week 8
Other outcomes:
measure: Clinical improvement
timeFrame: Week 24
Locations:
city: Yokkaichi
country: Japan
facility: Yokkaichi Hazu Medical Center
state: Mie
Study officials:
affiliation: Yokkaichi Hazu Medical Center
name: Takayuki Yamamoto, MD, PhD
role: STUDY_CHAIR
affiliation: Yokkaichi Hazu Medical Center
name: Takayuki Yamamoto, MD, PhD
role: STUDY_DIRECTOR
affiliation: Yokkaichi Hazu Medical Center
name: Takayuki Yamamoto, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: