louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05945082: Fusobacterium Nucleatum at Colorectal Cancer Sites
Official title: Presence of Fusobacterium Nucleatum at Colorectal Cancer Sites - Influencing Factors and Screening Possibilities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Periodontitis
Lead sponsor: Malmö University
Sponsor class: OTHER
Collaborators: name: Skane University Hospital
First posted: 2023-07-14
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Recent studies suggest an association of periodontitis with an overall increased cancer risk but also with cancer development in specific anatomic regions, such as in the colon. The gut microbiome in general and specifically Fusobacterium nucleatum have been described to likely affect colorectal cancer (CRC) development. The present project intends to evaluate the possible contribution of the oral cavity as a reservoir for dissemination of F.nucleatum to the colon. Additionally, the gut microbiome and dietary intake will be assessed as possible factors influencing colonization of CRC sites with F. nucleatum and an association of F.nucleatum colonization in the colon with parameters in the saliva and serum will be tested. One-hundred-fifty patients diagnosed with CRC will be included; after cancer diagnosis and before starting cancer treatment a periodontal examination will be done and saliva and serum samples and at the time-point of tumor resection a biopsy of the CRC sites will be collected.


Eligibility criteria: Inclusion Criteria:

* diagnosis of colorectal cancer

Primary outcomes:
measure: Presence of F.nucleatum in a colon cancer biopsy
timeFrame: At timepoint of biopsy
Secondary outcomes:
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Skane University Hospital
Study officials:
References:
Clinical trial NCT01772082: Use of Internet Mediated Walking Program and Pedometer in COPD
Official title: Randomized Study of Use of Internet Mediated Walking Program and Pedometer in COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Lead sponsor: VA Boston Healthcare System
Sponsor class: FED
Collaborators: name: University of Michigan
First posted: 2013-01-21
Enrollment: 114
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Persons with COPD are randomized to pedometer versus pedometer plus Internet mediated website to promote walking and physical activity. Primary outcome is daily step counts. Intervention lasts 3 months.


Eligibility criteria: Inclusion Criteria:

COPD, ability to walk, has Internet access

Exclusion Criteria:

COPD exacerbation in previous 4 weeks

Primary outcomes:
measure: Daily Step Counts
timeFrame: pre and 3 months post
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: VABoston Healthcare System
state: Massachusetts
Study officials:
References:
citation: Robinson SA, Wan ES, Shimada SL, Richardson CR, Moy ML. Age and Attitudes Towards an Internet-Mediated, Pedometer-Based Physical Activity Intervention for Chronic Obstructive Pulmonary Disease: Secondary Analysis. JMIR Aging. 2020 Sep 9;3(2):e19527. doi: 10.2196/19527.
citation: Wan ES, Kantorowski A, Polak M, Kadri R, Richardson CR, Gagnon DR, Garshick E, Moy ML. Long-term effects of web-based pedometer-mediated intervention on COPD exacerbations. Respir Med. 2020 Feb;162:105878. doi: 10.1016/j.rmed.2020.105878. Epub 2020 Jan 11.
citation: Robinson SA, Shimada SL, Quigley KS, Moy ML. A web-based physical activity intervention benefits persons with low self-efficacy in COPD: results from a randomized controlled trial. J Behav Med. 2019 Dec;42(6):1082-1090. doi: 10.1007/s10865-019-00042-3. Epub 2019 Apr 12.
citation: Wan ES, Kantorowski A, Homsy D, Kadri R, Richardson CR, Mori D, Moy ML. Self-reported task-oriented physical activity: A comparison with objective daily step count in COPD. Respir Med. 2018 Jul;140:63-70. doi: 10.1016/j.rmed.2018.05.012. Epub 2018 May 19.
Clinical trial NCT05665582: Family Members Affected by Substance Use Disorder - a Follow-up Study
Official title: Family Members Affected by Substance Use Disorder: How do They Cope and What Are Their Expressed Needs for Support?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Caregiver Burden
Lead sponsor: Sorlandet Hospital HF
Sponsor class: OTHER_GOV
First posted: 2022-12-27
Enrollment: 271
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Family members of patients in treatment for SUD at a Norwegian addiction treatment unit. The family members participated in a 4-day psychoeducational program

Brief summary: The present study registration relates to a quantitative sub-study of a larger mixed method study, including also a qualitative sub-study. Together, these investigations will provide complementary insights. The quantitative study is a follow-up study of close relatives (\> 16 years) of patients in treatment for substance use disorder (SUD) who participated in a group-based 4-day psychoeducational program.

Detailed description: The study is a follow-up study of close relatives (\> 16 years) of patients in treatment for SUDs who participated in a group-based 4-day psychoeducational program. The investigators will examine whether the family intervention in the specialized treatment services has benefits in terms of typical patient reported outcomes; physical complaints, psychological functioning, family functioning and QoL. The data collection has been finalized in 2017.

Eligibility criteria: Inclusion Criteria:

* All participants in a family program

Exclusion Criteria:

* None

Primary outcomes:
measure: Caregiver burden
timeFrame: Changes from baseline to the 3 months follow-up
measure: Family functioning
timeFrame: Changes from baseline to the 3 months follow-up
Secondary outcomes:
measure: Mental distress
timeFrame: Changes from baseline to the 3 months follow-up
measure: Physical complaints
timeFrame: Changes from baseline to the 3 months follow-up
measure: Well-being / quality of life
timeFrame: Changes from baseline to the 3 months follow-up
Other outcomes:
Locations:
city: Kristiansand
country: Norway
facility: Addiction Unit - Sørlandet Hospital
state: Agder
Study officials:
affiliation: Sørlandet Hospital
name: John-Kåre Vederhus, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vederhus JK, Kristensen O, Timko C. How do psychological characteristics of family members affected by substance use influence quality of life? Qual Life Res. 2019 Aug;28(8):2161-2170. doi: 10.1007/s11136-019-02169-x. Epub 2019 Mar 20.
Clinical trial NCT06858982: PMMHRI-Pitavastatin Registry
Official title: The Polish Mother's Memorial Hospital Research Institute Pitavastatin Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypercholesterolemia
Keywords: hypercholesterolemia
pitavastatin
Lead sponsor: Polish Mother Memorial Hospital Research Institute
Sponsor class: OTHER
First posted: 2025-03-05
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of the Department of Cardiology and Adult Congenital Heart Diseases, Department of Endocrinology, and outpatient cardiology and endocrinology clinics who is taking pitavastatin.

Brief summary: The PMMHRI-Pitavastatin Registry is a non-interventional, single-center registry conducted at the Polish Mother's Memorial Hospital Research Institute (PMMHRI). Established in January 2024, the registry enrolls all patients from the Department of Cardiology and Adult Congenital Heart Diseases, the Department of Endocrinology, as well as outpatient cardiology and endocrinology clinics who are prescribed pitavastatin.

Detailed description: The PMMHRI-Pitavastatin Registry is a non-interventional, single-center registry conducted at the Polish Mother's Memorial Hospital Research Institute (PMMHRI), the second-largest supra-regional hospital in Poland. The registry was initiated in January 2024 to systematically collect real-world data on patients prescribed pitavastatin, aiming to assess its effectiveness, safety, and impact on lipid and cardiovascular risk management.

The registry has included all patients from the Departments of Cardiology and Endocrinology, as well as outpatient cardiology and endocrinology clinics, who have been prescribed pitavastatin. The inclusion of a broad patient population allows for a comprehensive evaluation of treatment patterns and outcomes in routine clinical practice.

Patient data are extracted from electronic medical records and include:

Demographic parameters (age, sex, BMI, etc.) Relevant comorbidities (e.g., hypertension, diabetes, chronic kidney disease) Concomitant medications, including: Lipid-lowering therapy status (monotherapy vs. combination therapy), Anticoagulation status Lifestyle factors, such as smoking status Post hoc calculated cardiovascular risk scores, to stratify patients based on their predicted risk of major adverse cardiovascular events (MACE) Laboratory parameters, including lipid profiles, inflammatory markers, and metabolic indicators.

Eligibility criteria: Inclusion Criteria:

* patient takling pitavastatin based on the 2021 Polish Lipid Guidelines

Exclusion Criteria:

-

Primary outcomes:
measure: Patient's characteristic.
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Lodz
country: Poland
facility: Polish Mother's Memorial Hospital Research Institute
Study officials:
References:
Clinical trial NCT02827682: The Effect of IoC on Analgesia for Elderly Patients With Postoperative Effectiveness
Official title: The Effect of IoC on the Level of Intraoperative Analgesia for Elderly Patients With Postoperative Effectiveness
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Keywords: IoC
monitor
elderly
postoperative effectiveness
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The morbidity of colorectal cancer and the surgery number among elderly is growing. The investigators need to provide more advanced and specific monitoring technology for these patients. Index of consciousness (IoC) monitor is now widely used among endoscopy, cholecystectomy and other common clinical applications. The investigators goal is to verify whether using IoC monitor could help to improve the postoperative recovery after colorectal surgery.

Detailed description: Participants will be randomly assigned, in a 1:1 ratio, to receive IoC monitoring or BIS monitoring during the operation as the criteria for adjustment of analgesics use. The randomization sequence will be computer-generated, and randomization will be performed in blocks and will be stratified according to participating center. The number of dialysis and patient's recovery after the transplantation will be recorded. The participation of each patient is scheduled till they discharge from hospital.

Eligibility criteria: Inclusion Criteria:

* Patients aged over 60 years old that underwent Colorectal surgery in the First Affiliated Hospital of Xi'an Jiaotong University.

Exclusion Criteria:

* Having severe comorbidity history,for example,severe cardiac dysfunction
* Having central nervous system disease, severe endocrine, and history of mental disorders
* Alcoholic and long-term use of sedatives and opioids history
* Drug allergy history.

Primary outcomes:
measure: Duration time in PACU
timeFrame: 24 hours
Secondary outcomes:
measure: Use of remifentanil
timeFrame: during surgery
measure: Use of propofol
timeFrame: during surgery
measure: length of hospital stay (LOS)
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Other outcomes:
Locations:
city: Xian
country: China
facility: FirstXianJiaotongU
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Qiang Wang, PHD
role: STUDY_CHAIR
References:
Clinical trial NCT03198182: A Study to Test the Effects of BMS-986036 on the Body in Healthy Japanese and Non-Japanese Subjects
Official title: A Randomized, Parallel, Placebo-Controlled, Multiple Dose Study to Evaluate the Safety to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986036 in Healthy Japanese and Non-Japanese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metabolics
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-06-26
Enrollment: 63
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate safety, and tolerability of BMS-986036 and the effects the drug has on the body


Eligibility criteria: Inclusion Criteria:

* Healthy subjects, as determined by no clinically significant deviations from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
* Body mass index (BMI) of 25 to 40 kilogram / square meter (kg/m2), inclusive
* Additional criterion for Japanese subjects: Subjects must be first generation Japanese (born in Japan and not living outside of Japan for \> 10 years, and both parents are ethnically Japanese)

Exclusion Criteria

* Presence of any factors that would predispose the subject to infection (extensive periodontal disease that warrants surgical or medical treatment, unhealed open wounds)
* Any bone trauma (fracture) or bone surgery (hardware placement, joint replacement, bone grafting, or amputation) within 3 months of study drug administration
* Known or suspected autoimmune disorder, excluding vitiligo

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: Up to 42 days
measure: Incidence of serious adverse events (SAEs)
timeFrame: Up to 42 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cypress
country: United States
facility: WCCT Global
state: California
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT00171782: Hypertension and Cardiovascular Risk Factors
Official title: Valsartan Plus Hydrochlorothiazide in Patients With Hypertension and Cardiovascular Risk Factors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HYPERTENSION
Keywords: HYPERTENSION
VALSARTAN
VALSARTAN AND HYDROCHLOROTHIAZIDE
RISK FACTORS
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A study to evaluate the efficacy of valsartan+chydochlorothiazide in patients with stage 2 hypertension and cardiovascular risk factors.


Eligibility criteria: Inclusion Criteria:

* - Patients who give consent
* Men and women 18 to 80 years of age
* Patients with hypertension (systolic \>159 mm, diastolic \>100 mm)
* Patients meeting laboratory criteria

Exclusion Criteria:

* - Pregnant women
* Women not using approved contraception methods
* Secondary hypertension

Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Change from baseline systolic blood pressure at 8 weeks
Secondary outcomes:
measure: Blood pressure less than 140/90 mmHg at 8 weeks
measure: Reduction from baseline in diastolic blood pressure greater than or equal to 10 mmHg
measure: Reduction from baseline in systolic blood pressure greater than or equal to 20 mmHg
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT01287182: Trial of Ateronon in Patients With Coronary Disease to Evaluate Its Effectiveness in Assessing the Risk Factors of Atherosclerosis
Official title: Trial of Ateronon in Patients With Coronary Disease to Evaluate Its Effectiveness in Assessing the Risk Factors of Atherosclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atherosclerosis
Keywords: Asymptomatic Myocardial Ischemic patients
Lead sponsor: Omicron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-02-01
Enrollment: 100
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a trial of Ateronon in Patients with Coronary Disease to Evaluate its Effectiveness in Assessing the Risk Factors of Atherosclerosis.


Eligibility criteria: Inclusion Criteria:

* Men and Women with demonstrated Coronary Disease
* AtheroAbzyme positive during screening process
* Elevated Total Cholesterol
* Willingness to take study nutritional supplement once a day for 3 months

Exclusion Criteria:

* Women who are pregnant, nursing or intend pregnancy during the period of treatment
* Known milk, soy or whey allergy

Primary outcomes:
measure: to evaluate the effectiveness of Ateronon in inhibiting atherogenic lipid oxidation in patients with demonstrated coronary disease
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: to evaluate the potential effectiveness of Ateronon in lowering pulse rate as well systolic and diastolic blood pressure in patients with demonstrated coronary disease
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Rafic Hariri University Hospital
state: Bir Hasan
Study officials:
References:
Clinical trial NCT04834882: Burnout, Stress and Coping Strategies: Impact of the Covid-19 Epidemic
Official title: Burnout, Stress and Coping Strategies: Impact of the Covid-19 Epidemic on the Medical and Paramedical Staff in Reims University Hospital and EPSM Marne
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Burnout, Professional
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 649
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All healthcare workers participating will be included in the study

Brief summary: Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) is a novel coronavirus detected in Wuhan, China on December 2019. This virus is responsible for the infectious respiratory disease called Covid-19.

The psychological effects of this epidemic are found among the general population, but also healthcare workers. Some studies have shown that psychological disorders such as stress, anxiety, depressive symptoms, insomnia, denial, anger and fear, post-traumatic stress disorder are emerging among healthcare workers. However, there is currently insufficient data to evaluate the burnout during the COVID-19 pandemic.

The purpose of this study is to understand the impact of the covid-19 epidemic on stress and burnout on healthcare workers and their coping strategies.

Detailed description: Burnout syndrome, a state of professional exhaustion, is prevalent among the medical and paramedical staff. The covid-19 pandemic may generate more stress and increase the risk for burnout.

The aim of this study is to evaluate burnout (prevalence and intensity) and stress of among healthcare workers in COVID-19 units and non COVID-19 units. We also explore the supportive coping strategies need to reduce their stress and burnout.

Eligibility criteria: Inclusion Criteria:

* Medical (physicians, interns) and paramedical (nursing managers, nurses, care assistants) staff in Reims University Hospital and EPSM Marne
* Person who have attained majority
* Person consenting to participate to the study

Exclusion Criteria:

* Healthcare workers outside of Reims University Hospital and EPSM Marne
* Person who is not a healthcare professional

Primary outcomes:
measure: Assessment of burnout (prevalence and intensity)
timeFrame: Day 0
measure: Assessment of stress
timeFrame: Day 0
Secondary outcomes:
measure: Assessment of supportive coping strategies
timeFrame: Day 0
Other outcomes:
Locations:
city: Reims
country: France
facility: Chu Reims
Study officials:
References:
Clinical trial NCT03085082: Study of the Relationship Between Blood Groups,RH and Skeletal Malocclusion : a Cross Sectional Study
Official title: Study of the Relationship Between Blood Groups,RH and Skeletal Malocclusion in a Group of Egyptian Population: a Cross Sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Class II Malocclusion
Class III Malocclusion
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-03-21
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients with skeletal malovclusion seeking medical care in the orthodontic department of cairo university for six months

Brief summary: the study is searching if there is a relationship between the blood groups and RH and the skeletal malocclusion using the skeletal class I as a control group

Detailed description: The study will be conducted on the patients seeking medical care in the orthodontic department Cairo University, for six months all patients with class II and class III malocclusion will be recruited based on Wits appraisal measured from the cephalometric X-ray taken routinely during orthodontic examination. Then a group of class I arch length discrepancy patients will be used as control. A blood sample will be withdrawn and taken to the Cairo university laboratory to analyze the blood group and RH .a statistical analysis will be performed to detect a relationship between skeletal malocclusion and the blood groups as compared to the control

Eligibility criteria: Inclusion Criteria:

skeletal class I,II and III patients non syndromic patients above the age of 18 no previous surgical intervention for correction of skeletal malocclusion

Exclusion Criteria:

* syndromic patients
* cleft patients
* patients with previous surgery to correct skeletal malocclusion

Primary outcomes:
measure: relationship between blood group and skeletal malocclusion
timeFrame: the recruitment will be for six months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: head of department of orthodontics cairo university
name: Amgad qaddah, professor
role: STUDY_DIRECTOR
References:
citation: Flannery, P. M. (1969). Loyola eCommons The Abo Human Blood Groups and Skeletal Class IIi Malocclusions.
citation: Schnibben, C. L. (1968). Loyola eCommons A Study of the Relationships of the ABO Human Blood Groups , the Rh Factor and Hereditary Malocclusions of the Skeletal Type , Class II , Division 1.
citation: Gheisari R, Ghoreishian M, Movahedian B, Roozbehi A. The association between blood groups and maxillofacial deformities. Indian J Plast Surg. 2008 Jul;41(2):138-40. doi: 10.4103/0970-0358.44921.
citation: Science, D. (2015). International Journal of Pharma and Bio Sciences ISSN CRANIOFACIAL MORPHOLOGY WITH GENETIC INFLUENCE OF ABO BLOOD, 6(4), 412±418.