louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03203135: Assesment of the Impact of a Nutritional Prevention Programme for Employees in Staggered Hours.
Official title: Assesment of the Impact of a Nutritional Prevention Programme for Employees in Staggered Hours.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shift-work
Eating Behavior
Lead sponsor: Institut Pasteur de Lille
Sponsor class: OTHER
First posted: 2017-06-29
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Staggered work affects about 20% of French employees and its health risks are now well known. They concern physical health (sleep disorders, weight gain, cancer, cardiovascular disorders, nutritional problems, etc.) and psychological health. Faced with these "alarming" findings, it is necessary to find ways of improvement and levers of action to prevent them.

This project aims to set up and evaluate a nutritional health prevention programme for the benefit of employees in staggered hours from CITEO. CITEO is a company of social mediation.

The objectives of the project are twofold: to evaluate the impact of working conditions in shifted schedules on food behavior and on to improve their eating behaviors.

How? Focusing on the pleasure of eating through a nutritional prevention program in which various and varied actions will be proposed but always adapted to the life of the company (example: culinary demonstration, physical activity, provision of baskets of Fruits, etc.).


Eligibility criteria: Inclusion Criteria:

* Participants working at CITEO in staggered hours

Exclusion Criteria:

* Pregnant woman, person with severe pathology

Primary outcomes:
measure: Waist circumference
timeFrame: 14 months
measure: Weight
timeFrame: 14 months
measure: Blood pressure
timeFrame: 14 months
measure: Metabolic parameters (Total cholesterol, HDL, LDL, Triglycerdies, glycemia)
timeFrame: 14 months
measure: Food consumption behavior and food representations
timeFrame: 14 months
measure: Physical activity level
timeFrame: 14 months
measure: Height
timeFrame: 14 months
Secondary outcomes:
measure: Motivation to change habits
timeFrame: 14 months
measure: Body Feeling
timeFrame: 14 months
measure: Well-being
timeFrame: 14 months
measure: Stress
timeFrame: 14 months
measure: Sleep quality
timeFrame: 14 months
measure: Fatigue
timeFrame: 14 months
Other outcomes:
Locations:
city: Lille
country: France
facility: NutrInvest - Institut Pasteur de Lille
state: Nord
Study officials:
affiliation: IPL
name: Jean-Michel LECERF, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03329235: Intraosseous With Intra-articular Injection of Platelet Rich Plasma in Treatment of Knee Osteoarthritis
Official title: Intraosseous With Intra-articular Injection of Platelet Rich Plasma Versus Hyaluronic Acid in Treatment of Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Osteoarthritis, Knee
Lead sponsor: Cangzhou Central Hospital
Sponsor class: OTHER
First posted: 2017-11-01
Enrollment: 86
Sex: ALL
Minimum age (years): 40
Maximum age (years): 73
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to compare the efficacy of treatment in three groups of patients with knee osteoarthritis (OA) given a combination of intraosseous with intra-articular injection of platelet rich plasma (PRP), intra-articular injection of PRP and a single application of hyaluronic acid (HA).

Detailed description: Methods Eighty-six patients from January 2015 to June 2015 with grade II to grade III knee osteoarthritis according to the Kellgren-Lawrence classification were randomly divided into 3 groups to receive either PRP or HA. Group A received intra-articular injection of PRP 2 ml combination with medial tibial plateau and medial femoral condyle injection of PRP 2 ml (once more 2 weeks later). Group B were treated with 2 ml of PRP intra-articular injection every 14 days for a total of two injections. Group C received intra-articular injection of hyaluronic acid 2 ml every 7 days for five injections. All patients were evaluated by the Visual Analogue Scale (VAS) and the Western Ontario and McMaster Universities (WOMAC) score before the treatment and at 1st, 3rd, 6th, 12th and 18th months.

Eligibility criteria: Inclusion Criteria:

* Unilateral symptomatic knee with pain for at least 1 month or swelling.
* Radiographic findings of knee degeneration (Kellgren-Lawrence score of II - III).
* Age 40-73 years.
* Body mass index (BMI) 18-32.5).
* Knee stability without a severe trauma history.

Exclusion Criteria:

* Bilateral knee osteoarthritis indicative of treatment for both knees.
* Kellgren-Lawrence score greater than III.
* BMI \>32.
* Age \>73 years.
* Systemic autoimmune rheumatic diseases and blood disorders.
* Active immunosuppressive or anticoagulant therapy.
* Intra-articular injection to the knee within the previous 1 year or previous joint infection.
* use of corticosteroids for 3 weeks before the procedure.
* use of nonsteroidal anti-inflammatory drugs (NSAIDs) in the 3 weeks before treatment.

Primary outcomes:
measure: WOMAC scores
timeFrame: At the 18th month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05297435: Psychotraumatology in Somatic Medicine
Official title: Psychotraumatology in Somatic Medicine - Gynecological Consultation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma, Psychological; Somatic
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
First posted: 2022-03-28
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female patients of the preventive consultation of the gynecological clinic of the cantonal hospital St.Gallen

Brief summary: Psychotraumatology is clinically highly relevant, especially in the medical-somatic disciplines. Despite progress in recent decades, the clinical care is still inadequate - with unfavorable health effects for affected patients. There are avoidable burdens for involved clinicians and the health care system as a whole, also in terms of costs. With this background, our long-term project combines different research levels. Besides clarifying the clinical phenomenon, it aims to examine 1) the influence of traumatization on the physician-patient interaction as well as 2) the current psychological stress of the patients. Furthermore, 3) moderating factors on the side of the physicians, such as professional experience on the physician-patient interaction will be examined.


Eligibility criteria: Inclusion Criteria:

* At least 18 years old
* Female patients of the preventive consultation of the gynecological clinic of the cantonal hospital St.Gallen

Exclusion Criteria:

* Severe mental disorder (e.g. dissociative disorder)
* Insufficient knowledge of German

Primary outcomes:
measure: Quality of physician-patient relationship
timeFrame: Day 0
Secondary outcomes:
measure: Early traumatization
timeFrame: Day 0
measure: Current traumatization
timeFrame: Day 0
measure: Anxiety & Depression
timeFrame: Day 0
measure: Dissociative symptoms
timeFrame: Day 0
measure: General distress
timeFrame: Day 0
Other outcomes:
Locations:
city: St.Gallen
country: Switzerland
facility: Katja Haemmerli Keller
Study officials:
References:
Clinical trial NCT05043935: The Effect of Leukocyte and Platelet-rich Fibrin With Antimicrobial Photodynamic Therapy in Aggressive Periodontitis
Official title: The Effect of Leukocyte and Platelet-rich Fibrin With Antimicrobial Photodynamic Therapy in Treatment of Aggressive Periodontitis Patients: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: L-PRF
Photodynamic Therapy
Aggressive Periodontitis
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2021-09-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Antimicrobial photodynamic therapy (aPDT) is associated with photosensitizing agents which promote the generation of free radicals and singlet oxygen, which are cytotoxic to certain bacteria. Leukocyte and platelet-rich fibrin (L-PRF) has been used extensively in the treatment of intrabony defects and achieved excellent results. It acts as an immune regulation node with inflammation control abilities, including a slow continuous release of growth factors which stimulates periodontal regeneration. The aim of this study is to evaluate the adjunctive effects of aPDT with and without L-PRF in aggressive periodontitis patients.


Eligibility criteria: Inclusion Criteria:

* systemically healthy
* non- smoker,
* not received any periodontal treatment within the last 6 months,
* no antibiotics, anti- inflammatory drugs or any other medication taken within the last 6 months

Exclusion Criteria:

* any systemic disease that might influence the prognosis of periodontal disease and outcome of the treatment,
* any medical condition that required antibiotic prophylaxis before the treatment,
* smoking,
* pregnancy and lactation,
* ingestion of antibiotics, anti-inflammatory drugs or any other medication during the study period,
* any physical limitations or restrictions that might preclude normal oral hygiene procedures.

Primary outcomes:
measure: Clinical evaluation and measurements of the defect in millimeters
timeFrame: 9 months
measure: Radiographic evaluation and measurements of the defect in millimeters
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Faculty of Dentistry, Kafrelsheikh University
Study officials:
affiliation: Kafrelsheikh University
name: Dalia R Issa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05506735: The Role of the Seven Sweeps in the Prevention of the Prostate Cancer Among Those With a Positive Family History
Official title: The Role of the Seven Sweeps in the Prevention of the Prostate Cancer Among Those With a Positive Family History: A Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Prostatic Neoplasms
Prostatic Hyperplasia
Keywords: Prostate cancer
Prostate hyperplasia
The seven sweeps
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2022-08-18
Enrollment: 215
Sex: MALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We included 350 participants and 135 if them were excluded. Only 215 who full-filled the criteria were included.

Brief summary: The seven sweeps is a recommended act performed by men after urinating in order to be confident that no urine is left in the urethra, and its not compulsory to perform. It is performed by the following way: after urinating, the anus is first purified if it has become impure; then, the middle finger of the left hand is slid three times from the anus up to the scrotum; then, the thumb is placed on the penis and the forefinger is placed under the penis, and the thumb and forefinger are pulled three times along the penis up to the point of circumcision; finally, the end of the penis is pressed three times.

Detailed description: The investigators have investigated 350 people who have been doing this habit for at least 20 years of their life and they have a family history of prostatic cancer to check the effect of this procedure on the prevention of the cancer. The investigators have excluded 135 participants of them because they have not full-filled the criteria of inclusion. So 215 of them have been included and investigated using PSA and prostate ultrasound.

Eligibility criteria: Inclusion Criteria:

* Family history of prostate cancer, more than 40 years of age, is doing the seven sweeps habit for at least 20 years, has not any urinary problems or chronic diseases.

Exclusion Criteria:

* No family history of prostate cancer, less than 40 years of age of more than 70 years old, has a urinary problem or chronic diseases.

Primary outcomes:
measure: Prostate specific antigen
timeFrame: 30 minutes
Secondary outcomes:
measure: Prostate ultrasound
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Nasiriyah
country: Iraq
facility: Al-Dar medical Center
state: Thi Qar
Study officials:
affiliation: University of Baghdad, College of Medicine
name: Hashim Talib T Hashim, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01912235: Arginine Synthesis in Healthy Adult Humans
Official title: Arginine Synthesis in Healthy Adult Humans: Does Proline or Glutamate Provide the 5-Carbon Chain?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Arginine synthesis
15N2 arginine, 1-13C Glutamine, 2-15N Glutamine, 15N Proline
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2013-07-31
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Arginine synthesis in mammals is a complex process involving at least 8 enzymes and intracellular and interorgan transfer of substrates.

The investigators have shown in our neonatal studies that there is no conversion of glutamate to arginine but proline label appears in ornithine, citrulline and arginine. It is clear therefore that arginine is synthesized in human neonates from proline.

In adults the source of the carbon backbone is less clear.

Detailed description: Through a series of test in healthy adults using tandem mass spectrometry with carbon labeled GLN and nitrogen labeled PRO to determine the dietary source for the carbon chain of ORN, CIT and ARG. Additionally, using Nitrogen labeled GLN, we will identify the source of the nitrogen atoms in these amino acids.

Using guanidino - 15N2 arginine, 1-13C Glutamine, 2-15N Glutamine and 15N Proline we will be able to:

1. determine the flux of arginine and proline in healthy adult volunteers
2. determine and compare the flux of carbon and nitrogen labeled glutamine
3. demonstrate whether glutamine or proline provides the carbon backbone for ornithine, citrulline and arginine in adults.
4. the source of the N atoms in ornithine, citrulline and arginine.

Eligibility criteria: Inclusion Criteria:

* 5 men of average weight 80 kg will be studied
* healthy, with no know disease of liver, and/or kidney
* weight stable

Exclusion Criteria:

* weith loss or gain over the last three months
* on medications known to affect amino acid metabolism
* known liver, kidney disease condition

Primary outcomes:
measure: Blood Isotope Levels
timeFrame: 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Paul Pencharz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tomlinson C, Rafii M, Ball RO, Pencharz PB. Arginine can be synthesized from enteral proline in healthy adult humans. J Nutr. 2011 Aug;141(8):1432-6. doi: 10.3945/jn.110.137224. Epub 2011 Jun 15.
Clinical trial NCT00945035: Study of the Bioequivalence of the 20% and 30% Etoricoxib Tablet Formulations (0663-070)
Official title: An Open-Label, Randomized, 2-Period, Single-Dose, Balanced, Crossover Study in Healthy Subjects to Establish the Bioequivalence of the 20% and 30% Etoricoxib (MK0663) Formulations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2009-07-23
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will establish the bioequivalence of the 20%, milled, roller compaction final market image (FMI) etoricoxib tablets and 30% unmilled, roller compaction (UMC) etoricoxib tablets.


Eligibility criteria: Inclusion Criteria:

* Subject is in good health
* Subject agrees to follow the study guidelines

Exclusion Criteria:

* Subject is a smoker
* Subject has a history of adverse reactions caused by NSAIDs or allergies/intolerance to NSAIDs
* Subject is in a situation or has a condition/disease which may interfere with optimal participation in the study

Primary outcomes:
measure: Plasma Area Under the Curve (AUC(0 to Infinity)) for Etoricoxib
timeFrame: Through 120 Hours Postdose
measure: Peak Plasma Concentration (Cmax) for Etoricoxib
timeFrame: Through 120 Hours Postdose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00188435: Comparison of CXR and MnDCT
Official title: A Comparison of Chest Radiography and Minimum Dose Chest CT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Dyspnoea
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A comparison of chest x-ray (CXR) and Minimum dose CT (MnDCT) in the acutely ill patient. The hypothesis is that MnDCT is more sensitive than CXR in the detection of acute findings in the acutely ill patient.

Detailed description: A comparison of chest x-ray (CXR) and Minimum dose CT (MnDCT) in a cohort of 100 patients admitted for acute respiratory distress. Chest radiography (CXR) is compared to Minimum Dose CT (MnDCT) for the detection of consolidation;lung nodules, heart failure.

Eligibility criteria: Inclusion Criteria:

* All patients admitted for investigation of acute pulmonary embolus

Exclusion Criteria:

* none

Primary outcomes:
measure: A comparison of CXr and MnDCT in the detection of acute findings within the thorax
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Health Network, Toronto
name: Narinder Paul, FRCP C
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04096235: A Study to Evaluate the Use of the Neotech RAM Nasal Cannula for CPAP and Bi-PAP Application in Infants 28-42 Weeks Gestation in a Neonatal Intensive Care Unit (NICU)
Official title: A Pilot Study to Evaluate the Use of the Neotech RAM Nasal Cannula for CPAP and Bi-PAP Application in Infants 28-42 Weeks Gestation in a Neonatal Intensive Care Unit (NICU)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Neonatal Respiratory Distress
Lead sponsor: Englewood Hospital and Medical Center
Sponsor class: OTHER
First posted: 2019-09-19
Enrollment: 14
Sex: ALL
Minimum age (years): 28
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will explore the RAM Nasal Cannula as a means of providing CPAP and Bi-PAP to infants 28-42 weeks gestation to prevent nasal septal erosion.


Eligibility criteria: Inclusion:

* Infants with birth weight \< 1500 grams AND/OR \<32 weeks gestational age
* Infants between 34-42 weeks gestational age and exclusive breastfeeding with no risk of nasal septal erosion OR Infants between 28-42 weeks gestational age at risk of nasal septal erosion

Exclusion:

* Infants with major congenital and upper airway anomalies
* Infants requiring ETT (endotracheal tube) mechanical ventilation
* Infants receiving no respiratory support

Primary outcomes:
measure: NCPAP
timeFrame: 5 days
measure: Bi-PAP
timeFrame: 5 days
measure: NCPAP
timeFrame: 5 days
measure: NCPAP
timeFrame: 5 days
measure: Bi-PAP
timeFrame: 5 days
measure: Bi-PAP
timeFrame: 5 days
Secondary outcomes:
measure: High Flow Humidity
timeFrame: 5 days
measure: High Flow Humidity
timeFrame: 5 days
measure: High Flow Humidity
timeFrame: 5 days
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Englewood Hospital and Medical Center
state: New Jersey
Study officials:
References:
Clinical trial NCT01180335: Standard Neoadjuvant Chemotherapy Versus Genomic Driven Chemotherapy in Patients With Breast Cancer
Official title: Randomized Trial Comparing Standard Neoadjuvant Chemotherapy to Genomic Driven Chemotherapy Regimen in Patients With Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Genomic driven chemotherapy
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
Collaborators: name: Institut Curie
First posted: 2010-08-12
Enrollment: 303
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This randomized trial is comparing a standard neoadjuvant chemotherapy with a genomic driven chemotherapy in patients with breast cancer.

Detailed description: After a core biopsy, each tumor is profiled using Affymetrix U133plus2 gene expression array. DLD30 score (Hess, JCO, 2006) and TOP2A expression are quantified. Patients are then either treated with 4FEC followed by 4 docetaxel (standard arm) or by a genomic-driven regimen (experiemental arm). In the experimental arm, patients with high DLD30 receive 3 months weekly paclitaxel followed by 4 FEC, patients with high TOP2A receive 4FEC then 4 docetaxel, patients with low DLD30 and low TOP2A are treated with 6 cycles of docetaxel-capecitabine.

Eligibility criteria: Inclusion Criteria:

* Invasive breast cancer not eligible for conservative surgery
* Her2 negative
* Amount of tumor cells \>30% on HES slides
* RIN\>6 and amount of RNA\>1 ug
* No metastases
* Subject, age \> 18 years and \<65 years old
* Signed written informed consent
* PS 0-1
* No previous treatment for breast cancer
* Adequate organ function
* FEVG \>50%

Exclusion Criteria:

* In situ carcinoma
* Multifocal cancers
* Her2+
* Presence of metastasis
* Genomic testing not feasible because of tumor cells \<30%, RIN\<6, insufficient amount of RNA
* Organ dysfunction that contraindicates chemotherapy

Primary outcomes:
measure: Complete response rate based on the histology
timeFrame: Tumoral assessment at 4 and 8 cycles
Secondary outcomes:
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Centre René Huguenin
name: Florence LEREBOURS, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut Curie
name: Jean-Yves PIERGA, MD
role: PRINCIPAL_INVESTIGATOR
References: