louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03336151: FOP Nutrition Label in Campus Cafeteria
Official title: Impact of a Front-of-pack Nutrition Label on the Nutritional Quality of Purchases in Campus Cafeteria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Labelling
Lead sponsor: University of Paris 13
Sponsor class: OTHER
First posted: 2017-11-08
Enrollment: 119219
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: After a control period with no specific front-of-pack labeling, the intervention consists in the apposition of a front-of-pack labeling (Nutri-Score) to individual foods in a campus cafeteria. All foods are individually labeled.
Primary purpose: OTHER

Brief summary: This study evaluates the impact of the introduction of a front-of-pack nutrition label on foods and beverages sold in a campus cafeteria in France on the nutritional quality of purchases.

Detailed description: The introduction of front-of-package nutrition labelling is thought to help consumers making healthier food choices at the point-of-purchase.

Recently, the French government has selected the Nutri-Score as single front-of-pack nutrition label.

Evaluations of the Nutri-Score suggest it is in helping consumers making healthier choices. However, its impact in vulnerable populations has not yet been tested. Students are thought to be a vulnerable population due to their limited resources and to their unhealthy food choices.

The objective of the present study is to investigate the impact of the introduction of the Nutri-Score in campus cafeterias on the nutritional quality of food purchases. The intervention is conducted during several months, with a control period without front-of-pack nutrition labelling at the beginning of the university year.

Data on purchases is collected regularly through receipts, and the nutritional quality of purchases is evaluated over time between the intervention situation and the control situation.

Eligibility criteria: Inclusion Criteria:

* All subjects purchasing foods or beverages in the selected campus cafeteria

Exclusion Criteria:

* None No individual data is collected. Only purchases data is collected (cash register sales data)

Primary outcomes:
measure: Overall nutritional quality of purchases
timeFrame: Every 15 days, up to 6 months
Secondary outcomes:
measure: Energy content of purchases
timeFrame: Every 15 days, up to 6 months
measure: Saturated fat content of purchases
timeFrame: Every 15 days, up to 6 months
measure: Sugar content of purchases
timeFrame: Every 15 days, up to 6 months
measure: Sodium content of purchases
timeFrame: Every 15 days, up to 6 months
measure: Fiber content of purchases
timeFrame: Every 15 days, up to 6 months
measure: Protein content of purchases
timeFrame: Every 15 days, up to 6 months
Other outcomes:
Locations:
city: Nice
country: France
facility: CROUS Nice - Toulon
Study officials:
References:
Clinical trial NCT00203151: A Study to Evaluate the Tolerability, Safety and Effectiveness of Edratide in the Treatment of Lupus
Official title: A Multi-National, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Parallel Group Study to Assess the Efficacy, Tolerability and Safety of Edratide for Subcutaneous Injection in Systemic Lupus Erythematosus (SLE)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Systemic Lupus Erythematosus
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is thought that Edratide may be able to reduce the symptoms of SLE.


Eligibility criteria: Inclusion Criteria:

1. Willing and able to give written informed consent
2. Between the ages of 18 and 65 years (inclusive)
3. Fulfilled at least 4 ACR classification criteria
4. SLE patients with moderate, active disease
5. Subjects on stable dose of SLE medications for at least 4 weeks before randomization.
6. Women of child-bearing potential must practice a medically acceptable method of contraception..
7. Must understand the requirements of the study and agree to comply with the study protocol.

Exclusion Criteria:

1. Any condition which the investigator feels may interfere with participation in the study.
2. Subjects having a history of chronic infection
3. Subjects with a history of immunodeficiency syndrome or malignancy,
4. Subjects who received any investigational medication (including DHEA) within 3 months prior to randomization,
5. Subjects treated with any cytotoxic agents in the 3 months prior to randomization.

Primary outcomes:
measure: Improvement of Disease Activity Score
timeFrame: 30 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Dan Goldsatub, Ph.D.
role: STUDY_DIRECTOR
References:
citation: Urowitz MB, Isenberg DA, Wallace DJ. Safety and efficacy of hCDR1 (Edratide) in patients with active systemic lupus erythematosus: results of phase II study. Lupus Sci Med. 2015 Aug 11;2(1):e000104. doi: 10.1136/lupus-2015-000104. eCollection 2015.
Clinical trial NCT02589951: Missed Serious Medical Illness in Psychiatric Patients Seen in an Academic Emergency Department
Official title: Missed Serious Medical Illness in Psychiatric Patients Seen in an Academic Emergency Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychiatric Patients, Serious Medical Illness
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2015-10-28
Enrollment: 2200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients greater than or equal to 18 years of age presenting to London Health Sciences Centre, Victoria Hospital emergency department between October 1, 2014 - July 31, 2015 who were referred to adult psychiatry by the emergency physician

Brief summary: The purpose of this study is to determine the prevalence, etiology, and timing of missed Serious Medical Illness (SMI) in patients referred to adult psychiatry by emergency physicians, as well as to determine admission rates for SMI soon after discharge from an inpatient psychiatry admission.


Eligibility criteria: Inclusion Criteria:

* All patients greater than or equal to 18 years of age presenting to London Health Sciences Centre, Victoria Hospital emergency department between October 1, 2014 - July 31, 2015 who were referred to adult psychiatry by the emergency physician.

Exclusion Criteria:

* None

Primary outcomes:
measure: number of referrals to medical/surgical consult services within 14 days of psychiatric referral
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: Victoria site, London Health Sciences Centre
state: Ontario
Study officials:
References:
Clinical trial NCT01179451: Late Cardial Assessment in Children Who Were Diagnosed With Post Streptococcal Reactive Arthritis - a Long Term Study
Official title: Late Cardial Assessment in Children Who Were Diagnosed With Post Streptococcal Reactive Arthritis - a Long Term Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post Streptococcal Reactive Arthritis
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2010-08-11
Enrollment: 146
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: out patient rheumatology clinic

Brief summary: The purpose of this study is to determine whether there is late cardial involvement in children diagnosed with post streptococcal reactive arthritis after discontinuation of prophylactic antibiotic therapy.


Eligibility criteria: Inclusion Criteria:

* PSRA patients under 18 who were diagnosed at least one year prior to the study

Exclusion Criteria:

* PSRA patients under 18 who were diagnosed less one year prior to the study
* patients who do not fulfill PSRA criteria
* patients who fulfill Jones criteria
* patients with a known heart defect

Primary outcomes:
measure: cardiac valve function
timeFrame: at least 1 year after termination of antibiotic treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir medical center
Study officials:
References:
Clinical trial NCT04456751: Is Redo Pediatric Cardiac Surgery a Risk Factor for Transfusion?
Official title: Is a Reintervention for Pediatric Cardiac Surgery Associated With Higher Blood Transfusion Requirements ?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Cardiac Surgery
Transfusion
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2020-07-02
Enrollment: 2439
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients between 0 and 16 years undergoing cardiac surgery with cardiopulmonary bypass in our institution. We will exclude Jehovah's witness patient as they refuse a transfusion.

Brief summary: In pediatric cardiac surgery, transfusion requirements are associated with age, development status, pathology, type of surgical intervention and extracorporeal bypass. In adult cardiac surgery, reinterventions (redo)are clearly linked to higher transfusion rates. The investigators want to study if this association is also true in pediatric cardiac surgery.

Detailed description: Whereas in adult cardiac surgery, redo-interventions are clearly linked to a higher transfusion rate, this is not really known in paediatric cardiac surgery. In this retrospective study, the investigators will analyse our database for paediatric cardiac surgery patients aged 0-16 years and operated between 2002 and 2017. Patients with a single cardiac surgery will be compared to patients with a second cardiac operation under extracorporeal bypass. The investigators will test the variables for normal distribution using a Shapiro-Wilk test. Non normal distributed variables will be compared by a non-parametric test (Mann Whitney U), frequency analysis will be done by a Chi-Square test. A univariate analysis will determine predicting factors for transfusion. Factors with a P value \< 0.1 will be analysed by a multivariate analysis to determine independent factors for transfusion. Odds with 95% confidence intervals will be calculated. A P value \< 0.05 will be considered statistically significant.

Eligibility criteria: Inclusion Criteria:

* Patients between 0 and 16 years
* Cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

* Jehova's witness

Primary outcomes:
measure: Transfusion of packed red cells (mL/kg)
timeFrame: Day of operation up to 5 days postop
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Hôpital Universitaire des Enfants Reine Fabiola
Study officials:
affiliation: CHU Brugmann
name: Denis Schmartz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02973451: Laparoscopic Guided Transversus Abdominis Plane Block Versus Trocar Site Infiltration in Gynecologic Laparoscopy.
Official title: Laparoscopic Guided Transversus Abdominis Plane Block Versus Trocar Site Local Anesthetic Infiltration in Gynecologic Laparoscopy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Post Operative Local Anaesthesia
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2016-11-25
Enrollment: 80
Sex: FEMALE
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: to compare between Laparoscopic Guided Transversus Abdominis Plane Block and Trocar Site Infiltration as postoperative analgesia in Gynecologic Laparoscopic surgery.

Detailed description: two groups of patients who are eligible for Gynecologic Laparoscopy were randomized to either Laparoscopic Guided Transversus Abdominis Plane Block or Trocar Site Infiltration at the end of the operation.

Eligibility criteria: Inclusion Criteria:

* patients Need Gynecologic Laparoscopy

Exclusion Criteria:

* diagnosed with chronic pain syndrome
* have a postoperative intraperitoneal drain
* necessitating alteration to laparotomy.

Primary outcomes:
measure: Pain Scores
timeFrame: 24 Hours
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University
Study officials:
affiliation: Zagazig University
name: ibrahim A el sharkwy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00955851: A Study To Examine Serologic Response In Hospitalized Patients Receiving Polyvalent Pneumococcal Vaccine
Official title: A Study To Examine Serologic Response In Hospitalized Patients Receiving Polyvalent Pneumococcal Vaccine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonia
Lead sponsor: George Washington University
Sponsor class: OTHER
First posted: 2009-08-10
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who have been admitted to the Medicine Ward under the Pneumonia Core Measure Protocol as stated by the Joint Commission, and who receive the polyvalent pneumococcal vaccine as an inpatient as indicated by ACIP guidelines.

Brief summary: Investigators in the Division of Infectious Diseases and the Division of Hospital Medicine of The George Washington University Medical Center are carrying out a study to determine if hospitalized patients receiving the polyvalent pneumococcal vaccine during an acute illness develop an adequate antibody response. The study group will consist of individuals diagnosed with pneumonia and admitted to the Medicine ward under the Pneumonia Core Measure Protocol, which assigns appropriate patients for vaccination based on the current guidelines from the Advisory Committee on Immunization Practices (ACIP).


Eligibility criteria: Inclusion Criteria:

* Males or female patients ages 18 or older
* Diagnosis of pneumonia requiring hospitalization
* Admission to the Medicine Ward under the Pneumonia Core Measure protocol
* Eligible to receive standard of care pneumococcal vaccine by the treating physician
* Able to receive an injection
* Able to provide informed consent

Exclusion Criteria:

* Preexisting history of immunosuppression, to include any of the following: HIV/AIDS, Chronic corticosteroid use, Malignancy requiring myeloablative chemotherapy, Hematologic malignancy, History of solid organ or stem cell transplant
* Pregnancy
* Receipt of pneumococcal vaccine within the last 5 years
* Prior history of hypersensitivity reaction to the vaccine
* Unable to return for follow-up testing

Primary outcomes:
measure: A change in the pre- and post-vaccination pneumococcal serotype-specific IgG concentration from baseline will be considered protective based on the laboratory reference range.
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Washington DC
country: United States
facility: George Washington University Hospital
state: District of Columbia
Study officials:
References:
Clinical trial NCT05413551: Point-of-care Pharmacogenomic Testing to Optimize Isoniazid Dosing for Tuberculosis Prevention
Official title: Point-of-care Pharmacogenomic Testing to Optimize Isoniazid Dosing for Tuberculosis Prevention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Tuberculosis Infection
Isoniazid Adverse Reaction
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: Federal University of Mato Grosso
name: Fiocruz Mato Grosso do Sul
First posted: 2022-06-10
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is designed to determine whether modifying the dose of isoniazid for individuals according to their n-acetyltransferase 2 (NAT2) genotype could increase the probability of achieving equivalence of area-under-the-curve.


Eligibility criteria: Inclusion Criteria:

* Eligible for latent tuberculosis treatment by Brazil's national guidelines\*
* provides written informed consent to participate in the study

Exclusion Criteria:

* Evidence of active tuberculosis or currently under evaluation for active tuberculosis
* Receiving drugs that interact with Rifapentine (e.g. methadone, warfarin)
* Known intolerance or hypersensitivity to isoniazid or rifapentine
* Prior treatment for active or latent tuberculosis \> 14 days
* Close contact to isoniazid- or rifampicin-resistant tuberculosis (TB) case
* Neutropenia (absolute neutrophil count \<1000 cells/mm3)
* Clinical diagnosis of active liver disease or alcohol dependence
* alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 times the upper limit of normal

Primary outcomes:
measure: Isoniazid plasma area-under-the-curve
timeFrame: 1, 2, 8, and 24 hours post-dose
Secondary outcomes:
measure: Maximum isoniazid concentration (Cmax)
timeFrame: 1, 2, 8, and 24 hours post-dose
measure: Isoniazid concentration at 24 hours
timeFrame: 24 hours post-dose
Other outcomes:
Locations:
city: Campo Grande
country: Brazil
facility: Federal University of Mato Grosso do Sul
state: Mato Grosso do Sul
Study officials:
affiliation: Stanford University
name: Jason R Andrews, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Verma R, Patil S, Zhang N, Moreira FMF, Vitorio MT, Santos ADS, Wallace E, Gnanashanmugam D, Persing DH, Savic RM, Croda J, Andrews JR. A Rapid Pharmacogenomic Assay to Detect NAT2 Polymorphisms and Guide Isoniazid Dosing for Tuberculosis Treatment. Am J Respir Crit Care Med. 2021 Dec 1;204(11):1317-1326. doi: 10.1164/rccm.202103-0564OC.
Clinical trial NCT00755651: Studies on the H Pipelle, a New Device for Endometrial Sampling at Hysteroscopy
Official title: Studies on the H Pipelle, a New Device for Endometrial Sampling at Hysteroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abnormal Uterine Bleeding
Keywords: Menorrhagia
Uterine fibroids
Endometrial polyps
Endometrial cancer
Lead sponsor: Royal Free Hampstead NHS Trust
Sponsor class: OTHER
First posted: 2008-09-19
Enrollment: 180
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The investigators have developed a novel instrument for taking endometrial biopsies at no touch (vaginoscopic) hysterectomy which avoids the need to instrument the vagina with speculums and tenaculums, and also avoids the possible need for cervical dilatation. The investigators wish to study the ease of use and efficacy of the new device compared with traditional techniques of endometrial sampling at hysteroscopy.

Detailed description: We have developed a novel instrument for taking endometrial biopsies at no touch (vaginoscopic) hysterectomy which avoids the need to instrument the vagina with speculums and tenaculums, and also avoids the possible need for cervical dilatation. We wish to study the ease of use and efficacy of the new device compared with traditional techniques of endometrial sampling at hysteroscopy in terms of biopsy adequacy, the time taken to obtain a biopsy and patient experience.

Eligibility criteria: Inclusion Criteria:

* Indication to carry out diagnostic hysteroscopy
* Agrees and is suitable for outpatient/office hysteroscopy

Exclusion Criteria:

* Failed outpatient/office hysteroscopy

Primary outcomes:
measure: Discomfort
timeFrame: End of procedure
Secondary outcomes:
measure: Procedure time, biopsy adequacy
timeFrame: End of procedure
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Free Hospital
Study officials:
affiliation: Royal Free Hospital NHS Foundation Trust
name: Adam Magos, BSc MD FRCOG
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sharma M, Taylor A, di Spiezio Sardo A, Buck L, Mastrogamvrakis G, Kosmas I, Tsirkas P, Magos A. Outpatient hysteroscopy: traditional versus the 'no-touch' technique. BJOG. 2005 Jul;112(7):963-7. doi: 10.1111/j.1471-0528.2005.00425.x.
Clinical trial NCT00460551: Zalutumumab in Combination With Chemo-Radiation in a Certain Type of Lung Cancer
Official title: A Randomized, Open-label, Multi-center Trial Investigating Zalutumumab, a Human Monoclonal Anti-EGF Receptor Antibody, in Combination With Chemo-Radiation in Stage IIIA-IIIB Non Small Cell Lung Cancer Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Lead sponsor: Genmab
Sponsor class: INDUSTRY
First posted: 2007-04-16
Enrollment: 13
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: The purpose of the study is to investigate if treatment with zalutumumab in combination with chemotherapy and radiotherapy (chemo-radiation) will lead to a prolonged life in patients with lung cancer compared to patients treated with chemo-radiation alone.

Detailed description: Originally the study was planned as Part 1A, Part 1B and Part 2. Part 1A was one arm with zalatumumab fixed dose 8 mg/kg. Part 1B was planned as zalutumumab dose-titration and Part 2 adding a comparator. The trial was prematurely closed for enrolment when patients had only been enrolled in Part 1A due to published results showing increased toxicity from induction chemotherapy without any survival benefit.

Eligibility criteria: Inclusion Criteria:

* NSCLC stage IIIA-IIIB
* Performance status 0 or 1 (Zubrod or WHO Scale)

Exclusion Criteria:

* Evidence of metastases either in a separate lobe of the lung, or extra thoracic
* Patients with high risk of radiation pneumonitis and or compromised lung function
* Estimated life expectancy of less than 3 months
* Prior chemotherapy for lung cancer
* Prior radiotherapy to the chest
* Prior surgery with curative intent for lung cancer

Primary outcomes:
measure: Progression Free Survival Verified by Imaging Techniques.
timeFrame: Until disease progression
Secondary outcomes:
measure: Adverse Events
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Towson
country: United States
state: Maryland
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Gent
country: Belgium
facility: UZ Gent
city: Liege
country: Belgium
facility: CHR La Citadelle
city: Liege
country: Belgium
facility: CHU Sart-Tilman Domaine Universitaire du Sart-Tilman
city: Reims
country: France
facility: CHRU Reims, Hospital Maison Blanche
state: Cedex
city: Amsterdam
country: Netherlands
facility: VU Medisch Centrum (VUMC)
city: Sutton, Surrey
country: United Kingdom
facility: The Institute of Cancer Research and the Royal Marsden NHS Foundation Trust
Study officials:
affiliation: Genmab employee
name: Steen Lisby, MD, PHD
role: STUDY_DIRECTOR
References: