louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04834583: Corona And Manual Professions
Official title: COVID-19 Pandemic and Small Businesses in the Health Care Sector - Work Environment, Health and Economy of Swedish Chiropractors and Naprapaths
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Sophiahemmet University
First posted: 2021-04-08
Enrollment: 703
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Manual therapists, clinically active in Sweden

Brief summary: This observational study will follow the chiropractors and naprapaths in Sweden to study how work environment, health, and economy is changing during the COVID-19 pandemic.

Detailed description: All manual therapists that are members of a professional organization in Sweden will be invited to participate. The study started in November 2020 with follow-ups planned after 3,6 and 12 months.

All data-collection is taking place with digital questionnaires.

There are three main areas of interest:

1. Work environment (knowledge about viral contageon, protection, availability of protective measures, disturbances in care for patients)
2. Health (physical and psychological, how many caught the virus?)
3. Economy (income, costs, turnover)

Eligibility criteria: Inclusion Criteria:

* Chiropractor or naprapath working in Sweden
* clinically active
* belonging to a professional organization

Exclusion Criteria:

Primary outcomes:
measure: Work environment
timeFrame: 12 months
measure: Physical Health -Pain
timeFrame: 12 months
measure: Psychological Health -depression
timeFrame: 12 months
measure: Psychological Health -sleep
timeFrame: 12 months
measure: Economy
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Iben Axén
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01160783: Genetic Contributions to Autism Spectrum Disorders
Official title: Genetic Contributions to Autism Spectrum Disorders
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Autism Spectrum Disorder
Autism
Asperger's Syndrome
Pervasive Developmental Disorder
Keywords: Autism
Asperger's Syndrome
Asperger Syndrome
Autistic Disorder
Autism Spectrum Disorder
Pervasive Developmental Disorders
Pervasive Developmental Disorder-Not Otherwise Specified
Child Development Disorders, Pervasive
PDD-NOS
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2010-07-12
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with a diagnosis of an Autism Spectrum Disorder (autism, pervasive developmental disorder (PDD), or Asperger's syndrome) and their parents and/or siblings

Brief summary: This study is working towards gaining a better understanding of the genetic and environmental factors involved in autism spectrum disorders (ASD), which includes autism, pervasive developmental disorder (PDD), and Asperger's syndrome. The investigators hope that information gained from this study will lead to new ways of diagnosing and treating ASDs.

Detailed description: Participation generally takes less than 2 hours to complete and travel to Children's Hospital Boston is not required. Participants are asked some questions about their medical and family history. The investigators also request permission to review medical records related to the ASD diagnosis. Finally, the investigators obtain a small blood or saliva sample in order to search for genes that may be important in understanding ASD. The investigators can arrange for the blood draw through a participant's physician or a clinical laboratory and saliva samples can be obtained through the mail. The study questions are answered via telephone or mailed questionnaires. There is no cost to participate.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of an Autism Spectrum Disorder (autism, pervasive developmental disorder (PDD), or Asperger's syndrome)
* Age \> 18 months

Exclusion Criteria:

* Do not have the diagnosis of an ASD
* Participation in the "Phenotypic and Genetic Risk Factors in ASD" study at Boston Children's Hospital.

Primary outcomes:
measure: Gene expression levels
timeFrame: At sample collection
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Christopher Walsh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03015883: Alpha Radiation Emitters Device for the Treatment of Squamous Cell Carcinoma
Official title: A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters on Squamous Cell Carcinoma (First in Man)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Squamous Cell Carcinoma
Keywords: Squamous Cell Carcinoma
Alpha emitting radiation
Skin Cancer
Carcinoma, Squamous
HNSCC
Lead sponsor: Alpha Tau Medical LTD.
Sponsor class: INDUSTRY
First posted: 2017-01-10
Enrollment: 28
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: A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device.

Detailed description: This will be a prospective, first in man, controlled study, assessing the safety and efficacy of diffusing alpha emitters radiation therapy (DaRT) delivered through radioactive seeds inserted into the tumor.

This approach combines the advantages of local intratumoral irradiation of the tumor, as used in conventional brachytherapy, with the power of the alpha radiation emitting atoms, that will be introduced in quantities considerably lower than radiation therapy already used in patients.

Lesions with histopathological diagnosis of squamous cell carcinoma will be studied.

Reduction in tumor size 30 days after DaRT insertion will be assessed.

Safety will be assessed by the incidence, severity and frequency of all Adverse Events (AE).

Eligibility criteria: Inclusion Criteria:

1. Histopathological confirmation of squamous cell carcinoma.
2. Tumor size ≤ 5 centimeters in the longest diameter.
3. Age over 18.
4. Women of childbearing potential will have evidence of negative pregnancy test.
5. Life expectancy of more than 6 months.
6. Performance status 2 (ECOG scale) or less.
7. Signed informed consent form.

Exclusion Criteria:

1. Tumor maximal diameter \> 5 centimeters.
2. Tumor of Keratoacanthoma histology.
3. Performance status ≥ 3 (ECOG scale).
4. Patients with moribund diseases, autoimmune diseases or vasculitis.
5. Patients under immunosuppressive and/or corticosteroid treatment.
6. Volunteers that participated in other studies in the past 30 days.

Primary outcomes:
measure: Adverse Events
timeFrame: 30-45 days post seed insertion
measure: Reduction in Tumor size
timeFrame: 30-45 days post seed insertion
Secondary outcomes:
measure: Percent of NecroticTissue
timeFrame: 30-45 days post seed insertion
Other outcomes:
Locations:
city: Petah Tiqva
country: Israel
facility: Davidof Cancer Institution at the Rabin Medical Center Israel
Study officials:
affiliation: Davidof Cancer Institution at the Rabin Medical Center Israel
name: Noga Kurman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05617183: Compare the Auto-injector and Pre-filled Syringe of CT-P47 in Healthy Subjects
Official title: A Phase 1, Randomized, Open-label, Two-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of the Auto-injector and Pre-filled Syringe of CT-P47 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Celltrion
Sponsor class: INDUSTRY
First posted: 2022-11-15
Enrollment: 268
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a phase 1 study to compare the Pharmacokinetics and Safety of the Auto-injector and Pre-filled syringe of CT-P47 in Healthy Subjects.

Detailed description: CT-P47, containing the active ingredient tocilizumab, is a recombinant humanized monoclonal antibody that is being developed as a similar biological medicinal product to RoActemra/Actemra. The purpose of this study is to demonstrate the pharmacokinetics and safety of the Auto-injector and Pre-filled syringe of CT-P47 in healthy subjects.

Eligibility criteria: Inclusion Criteria:

1. Healthy male or female subjects between the ages of 19 to 55 years, both inclusive.
2. Subject with a body weight of ≥60 and ≤100 kg for male and ≥50 and ≤100 kg for female and a BMI between 18.5 and 28.0 kg/m2 (both inclusive) when rounded to the nearest tenth.

Exclusion Criteria:

1. A medical history and/or condition that is considered significant
2. Clinically significant allergic reactions, hypersensitivity
3. History or current infection of hepatitis B virus, hepatitis C virus, human immunodeficiency virus, or syphilis
4. Active or latent Tuberculosis
5. History of malignancy
6. Previous exposure to tocilizumab or any drug that targets IL-6

Primary outcomes:
measure: PK similarity demonstration by AUC
timeFrame: Day 43
measure: PK similarity demonstration by Cmax
timeFrame: Day 43
Secondary outcomes:
measure: Additional PK evaluation
timeFrame: Day 43
measure: Safety evaluation by TEAEs
timeFrame: Day 43
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University College of Medicine and Hospital
name: KyungSang Yu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00712283: Investigate the Effect of Neramexane Mesylate IR Tablet on Driving Fitness and Capability to Operate Machines in Healthy Volunteers
Official title: A Single Center, Randomized, Double-blind, Placebo-controlled, Parallel Group Design Study to Investigate the Effect of 12,5 mg, 25 mg, 50 mg and 75 mg Neramexane Mesylate IR Tablet on Driving Fitness and Capability to Operate Machines in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: fitness to drive
operate machines
To determine the fitness to drive and operate machines.
Lead sponsor: Merz Pharmaceuticals GmbH
Sponsor class: INDUSTRY
First posted: 2008-07-09
Enrollment: 64
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Determination of the ability to drive and operate machines after single and multiple oral dose of Neramexane as compared to placebo


Eligibility criteria: Inclusion Criteria:

* healthy volunteers, female and male
* age 21 - 50
* BMI 18 - 30 kg/m2
* experienced drivers with a valid driver's license and at least 3 years of driving practice

Exclusion Criteria:

* any clinically relevant finding on physical examination affecting the study objectives
* clinically relevant abnormalities in the ECG laboratory values
* history or present evidence of clinically relevant metabolic, renal, hepatic, pulmonary or cardiovascular disease, CNS disorders, or disturbance of bleeding diagnosis of malignancy
* females who are pregnant or breastfeeding

Primary outcomes:
measure: Fitness to drive
timeFrame: 15 days
Secondary outcomes:
measure: Psychometric test and motor control tests
timeFrame: 15 days
Other outcomes:
Locations:
city: Frankfurt/Main
country: Germany
facility: Merz Pharmaceuticals
Study officials:
References:
Clinical trial NCT05605483: Salad Bars in the National School Lunch Program: Impact on Dietary Consumption Patterns in Elementary School Students
Official title: Salad Bars in the National School Lunch Program: Impact on Dietary Consumption Patterns in Elementary School Students
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diet, Food, and Nutrition
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: George Mason University
name: University of North Carolina, Chapel Hill
name: The University of Tennessee, Knoxville
First posted: 2022-11-04
Enrollment: 6269
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All K-6th students who participate in the school lunch program and all cafeteria personnel at target schools

Brief summary: This project is a research study looking at what foods students choose and eat during school lunch and examines how salad bars impact what children eat.

Detailed description: This project applies a wait list control cluster randomized controlled trial to evaluate school salad bars. This project uses digital images (pictures) of labeled trays in the cafeteria before and after children eat lunch. This project also asks cafeteria workers about their thoughts about salad bars and their experiences with the salad bar program.

Eligibility criteria: Inclusion Criteria:

* Students: All K-6th grade students at target schools who participate in the school lunch program on rating day
* Cafeteria staff: All cafeteria personnel at the randomly selected target schools will be eligible to complete surveys

Exclusion Criteria:

* Students: Unsure sex of child
* Cafeteria staff: None

Primary outcomes:
measure: fruits and vegetables (FV) selection
timeFrame: Baseline to up to 6 weeks after salad bars installed
measure: FV consumption
timeFrame: Baseline to up to 6 weeks after salad bars installed
Secondary outcomes:
measure: energy intake (kcal)
timeFrame: Baseline to up to 6 weeks after salad bars installed
measure: dietary quality (Healthy Eating Index)
timeFrame: Baseline to up to 6 weeks after salad bars installed
measure: fruits and vegetables (FV) selection post-COVID-19
timeFrame: 4-6 weeks after salad bars re-installed
measure: FV consumption post-COVID-19
timeFrame: 4-6 weeks after salad bars re-installed
measure: energy intake (kcal) post-COVID-19
timeFrame: 4-6 weeks after salad bars re-installed
measure: dietary quality (Healthy Eating Index) post-COVID-19
timeFrame: 4-6 weeks after salad bars re-installed
Other outcomes:
Locations:
city: Henrico
country: United States
facility: Healthy Lifestyles Center at the Children's Hospital of Richmond at VCU
state: Virginia
Study officials:
affiliation: VCU
name: Melanie K Bean, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05241483: Remote Patient Monitoring and Detection of Possible Diseases With Artificial Intelligence Telemedicine System
Official title: SETİNT AI-Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Predictive Value of Tests
Vital Signs
Laboratory Critical Values
Relative Value Scales
Reference Values
Keywords: test
laboratory
relative value
homecar
artificial intelligence
Lead sponsor: Setint AI Robotic Sistem Egitim ve Danısmanlık San. Tic. A.S.
Sponsor class: OTHER_GOV
First posted: 2022-02-15
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients registered in the SETINT AI artificial intelligence Telemedicine system

Brief summary: Remote patient monitoring and detection of possible diseases with Artificial Intelligence Telemedicine System

Detailed description: Possible disease detection with artificial intelligence from the patient's vital values possible disease detection from the patient's examination records

Eligibility criteria: Inclusion Criteria:

* No Eligibility Criteria

Exclusion Criteria:

-

Primary outcomes:
measure: Patient symptoms and disease confirmation
timeFrame: May - October 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Düzce
country: Turkey
facility: Setint Ai
Study officials:
affiliation: SETINT AI Robotic Sistem Eğitim ve Danışmanlık San.Tic.A.Ş.
name: Aykut COŞKUN, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: SETINT AI Robotic Sistem Eğitim ve Danışmanlık San.Tic.A.Ş.
name: İsmail ÇELİK, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05440383: A Clinical Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia
Official title: A Phase III Confirmatory Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Uterine Fibroids (MeSH Heading: Leiomyoma)
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-06-30
Enrollment: 287
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Multi-center, randomized, double-blind, parallel-group study to confirm non-inferiority of KLH-2109 to Leuprorelin acetate in uterine fibroids patient with menorrhagia


Eligibility criteria: Inclusion Criteria:

* Premenopausal Japanese woman diagnosed with uterine fibroids
* Patients confirmed by transvaginal ultrasonography to have at least 1 myoma that meet all of the following conditions:
* Larger than a certain standard
* No calcification
* Not receiving surgical treatment
* Patients with a normal menstrual cycle
* Patients diagnosed with menorrhagia

Exclusion Criteria:

* Patients with complication or history of blood system diseases (salasemia, sickle erythrocyte anemia, folic acid deficiency, coagulation disorder, etc.) (excluding iron deficiency anemia and latent iron deficiency anemia)
* Patients with lower abdominal pain due to irritable bowel syndrome or lower abdominal pain due to severe interstitial cystitis
* Patients with undiagnosed abnormal genital bleeding

Primary outcomes:
measure: Proportion of subjects with a total PBAC score of less than 10 from Week 6 to 12 after beginning of study drug administration
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Proportion of subjects with a total PBAC score of less than 10 from Week 2 to 6 after beginning of study drug administration
timeFrame: Up to 24 weeks
measure: Proportion of subjects with a total PBAC score of less than 10 from Week 18 to 24 after beginning of study drug administration
timeFrame: Up to 24 weeks
measure: Proportion of subjects with a total PBAC score of less than 10 during 6 weeks before end of study drug administration
timeFrame: Up to 24 weeks
measure: Change from baseline in blood hemoglobin
timeFrame: Up to 24 weeks
measure: Change rate from baseline in myoma volume
timeFrame: Up to 24 weeks
measure: Change rate from baseline in uterine volume
timeFrame: Up to 24 weeks
measure: Change from baseline in UFS-QOL score
timeFrame: Up to 24 weeks
measure: Incidence of adverse events and adverse drug reactions
timeFrame: Up to 24 weeks
measure: Change rate from baseline in bone metabolic markers (BAP and serum NTx)
timeFrame: Up to 24 weeks
measure: Change rate from baseline in bone density (DXA)
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
facility: Clinical Resarch Site
Study officials:
affiliation: Kissei Pharmaceutical Co., Ltd.
name: Yoshitaka Shimizu
role: STUDY_DIRECTOR
References:
Clinical trial NCT02716883: Early Amniotic Membrane Transplantation in Bacterial Keratitis
Official title: Early Amniotic Membrane Transplantation in Bacterial Keratitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Keratitis of Both Eyes
Keywords: keratitis
AMT
bacterial keratitis
medication
Lead sponsor: Farabi Eye Hospital
Sponsor class: OTHER
First posted: 2016-03-23
Enrollment: 14
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study Investigators are going to do early amniotic membrane transplantation (AMT) for bacterial keratitis.

Detailed description: In this study investigators are going to do amniotic membrane transplantation (AMT), early in the first week for bacterial keratitis. Investigators are comparing this technique with no amniotic membrane transplantation (NAMT) in a clinical trial, Inform consent is going to be taken, then the enrolment population is added in the study. Investigators are going to compare the final scar size, the time to scar formation, perforation rate , early need to penetrating keratoplasty (PKP), risk of vision loss (being no light perception (NLP) between two groups.This trial has been approved by the review board in Tehran University of Medical Sciences.( 487/5671)

Eligibility criteria: Inclusion Criteria:

Bacterial keratitis being in the first week of diagnosis medically undergoing treatment

Exclusion Criteria:

thinning limbal extension intraocular extension underlying disease Nocardia keratitis

Primary outcomes:
measure: Time to scar formation
timeFrame: It needs at most 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00899483: Can Enhanced Glycemic Control in Type II Diabetics Improve Myocardial Protection During Coronary Artery Bypass Grafting?
Official title: Can Enhanced Glycaemic Control in Type II Diabetics Improve Myocardial Protection During Coronary Artery Bypass Grafting?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: University Hospital Birmingham
Sponsor class: OTHER
Collaborators: name: British Heart Foundation
First posted: 2009-05-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators have previously demonstrated that the administration of insulin in the form of an infusion with additional sugar and potassium may improve cardiovascular performance and reduce biochemical evidence of heart muscle injury in non-diabetic patients undergoing coronary artery surgery. The investigators now seek to demonstrate that similar benefits can be achieved in diabetic patients by administering insulin to maintain as near absolutely normal sugar levels as possible.


Eligibility criteria: Inclusion Criteria:

* Type II diabetes mellitus patients (as defined by WHO)
* Diet, oral hypoglycaemic or insulin therapy
* Undergoing elective and urgent coronary artery bypass surgery

Exclusion Criteria:

* Non-diabetics
* Emergency and redo CABG
* \< 18 years
* Pregnancy
* Dialysis-dependence
* History of CVA/TIA \< 6 months
* Heart valve disease requiring surgery
* STEMI \< 3 months

Primary outcomes:
measure: The difference in the mean left ventricular end-systolic volume index (LVESVI) after CABG and the amount of new permanent injury detected in the late CMRI study
timeFrame: 3 months post CABG
Secondary outcomes:
measure: Glycaemic control will be assessed 2 hours pre-operatively and 72 hours post-operatively. Measurement timings will be standardized allowing comparison of glycaemic control during different time-periods.
timeFrame: 72 hours post CABG
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: University Hospital Birmingham
state: West Midlands
Study officials:
References: