louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04459689: COVID-19 in PID Survey
Official title: Worldwide COVID-19 in Children and Adult Patients With Primary ImmunoDeficiencies (PID) Survey
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Primary Immune Deficiency
COVID
Lead sponsor: Imagine Institute
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 200
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with Primary Immune Deficiency and COVID-19

Brief summary: With the emergence of SARS-CoV-2 and the COVID-19 pandemic, there is an urgent need to understand the impact of infection on immunodeficient individuals. Whilst co-morbidities (such as diabetes, cancer, arterial hypertension, heart disease...) have been documented in people infected with SARS-CoV-2, there is currently no information on the consequences and outcomes for individuals with primary immunodeficiencies (PID).

Following the 1st phase of the survey (launched by Isabelle Meyts (ESID), Nizar Mahlaoui (CEREDIH \& IPOPI) and Kate Sullivan with Stuart Tangye (IUIS), that gave an idea of the number of affected PID patients and the impact of SARS-CoV-2 and directly focusing on obtaining this top level of information), we are launching the 2nd phase: "COPID19".

COPID19 survey is a secured online GDPR compliant platform based in Paris (Imagine Institute). It has been approved by the Paris-Necker-Enfants malades IRB and Ethics Committee. However, this retrospective survey is designed for global distribution. Data can be entered by a health care professional (mostly clinicians) through a personal login and password.

Each documenting person will have access to his/her own patients' data. COPID19 require a greater level of information than the 1st phase. The eCRF will be open to evolutions depending on progresses in our knowledge of this pandemic.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with a Primary Immune Deficiency
* COVID-19 (proven or probable)

Exclusion Criteria:

* Secondary Immune Deficiency
* Other Coronovirus infection

Primary outcomes:
measure: Survival of patients with PID affected by COVID-19
timeFrame: Baseline
measure: Rate of admission to ICU of patients with PID affected by COVID-19
timeFrame: Baseline
measure: Rate of oxygen therapy of patients with PID affected by COVID-19
timeFrame: Baseline
Secondary outcomes:
measure: Sequelae of patients with PID affected by COVID-19
timeFrame: Baseline
Other outcomes:
Locations:
city: Paris
country: France
facility: Imagine Institute
Study officials:
affiliation: Necker Enfants Malades University Hospital
name: Nizar MAHLAOUI, MD, MPH, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06709989: Chemical and Microbiological Exposure of Women on Dairy Cattle Farms
Official title: Expositions Chimique et Microbiologique Des Femmes Dans Les Exploitations Bovines laitières
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Occupational Exposure to Chemicals
Keywords: farmer
women
occupational exposure
chemicals
pesticides
biocides
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
Collaborators: name: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
name: Ecole des Hautes Etudes en Santé Publique
First posted: 2024-11-29
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult women working on dairy cattle farms in West area of France

Brief summary: Although professionals working on dairy cattle farms come into contact with a wide range of chemicals and microbiological agents, little is known about this possible exposure, which occurs a priori via inhalation and skin contact.

The aim of this research is to gain a better understanding of this chemical and microbiological exposure, and this research focuses in particular on professional women working on dairy cattle farms , who may be in charge of specific activities not commonly carried out by professional men.

Exposure to pesticides, antiparasitic products and disinfectants will be the first substances to be investigated, followed by other chemical or particulate compounds present in everyday and professional environments. Exposure to these compounds will be measured by their presence in the urine, feces (if possible) and hair of around 60 participating women, as well as in bovine tuft/head hair and, if possible, air samples taken in milking buildings.


Eligibility criteria: Inclusion Criteria:

* Adult woman working on a dairy cattle farm in the "Grand Ouest" region of France
* Woman who speaks and understands French

Exclusion Criteria:

* working less than 20h/week in dairy farms
* Woman under legal protection
* unsigned consent form

Primary outcomes:
measure: Exposure to chemicals of women working on dairy farms
timeFrame: At inclusion and at the end of the follow-up (for hair-concentrations), and during specific periods of agricultural activities (with two 4-day periods of urine sample collection, one period of faeces collection, and one week of environmental sampling)
Secondary outcomes:
measure: Exposure to other chemicals
timeFrame: At inclusion and at the end of the follow-up (for hair-concentrations), and during specific periods of agricultural activities (with two 4-day periods of urine sample collection, one period of faeces collection, and one week of environmental sampling)
Other outcomes:
Locations:
city: Rennes
country: France
facility: UMR1085 Irset
Study officials:
affiliation: Inserm UMR1085 Irset
name: Cecile Chevrier
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00947089: Role of Oxidized Regenerated Cellulose (ORC) Applied to "Dirty" Surgical Wounds
Official title: The Role of Oxidized Regenerated Cellulose in Preventing Infections at the Surgical Site: Prospective, Randomized Study in 98 Patients Affected by a Dirty Wound
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infections
Keywords: ORC (oxidized regenerated cellulose)
SSI (Surgical site infections)
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2009-07-27
Enrollment: 98
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether oxidized regenerated cellulose (ORC) is effective to reduce the risk of surgical site infections (SSI).

Detailed description: Surgical site infections (SSI) have significant clinical and economic repercussions since they still are the most common cause of nosocomial infections in surgical patients. It is important to bear in mind the growing number of SSI due to antibiotic-resistant microorganisms.

Eligibility criteria: Inclusion Criteria:

* have an ileostomy or a colostomy
* are candidates for an elective surgical procedure of ostomy closure

Exclusion Criteria:

* immunodeficiency
* chronic use of corticosteroids or antibiotics
* chemotherapy and/or radiotherapy in the last 30 days before closure of the stoma
* concomitant foci of infection

Primary outcomes:
measure: to reduce the microbial load and, consequently, the infection rate as compared to conventional local wound treatment
timeFrame: third post-operative day
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Digestive Surgery of the Catholic University of Sacred Heart
Study officials:
affiliation: UCSC
name: Sergio Alfieri, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00888589: Detection of Aggressive Breast Tumors Using Tc-99m-NC100692
Official title: Improved Sensitivity for the Detection of Aggressive Breast Tumors Using 99mTc-NC100692 and a Dual-headed Small Field of View CZT Gamma Camera.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: MBI
Molecular Breast Imaging
Breast
Breast Cancer
Molecular Imaging
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: GE Healthcare
First posted: 2009-04-27
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that are scheduled for a biopsy at the Mayo Clinic in Rochester, MN. The patients must have a suspicious lesion

Brief summary: The purpose of this study is to compare two types of radioactive drugs to see if they provide the same or different information about any disease that may be present in the participants breast.


Eligibility criteria: Inclusion Criteria:

* Have a lesion on mammogram, ultrasound or breast MRI that measured \< 15 mm in diameter, is considered suggestive or highly suggestive of malignancy according to the Breast Imaging Reporting and Data System Atlas criteria (BIRADS 4b, 4c or 5), and is scheduled for biopsy (needle biopsy and/or surgical biopsy).

OR

* Have a lesion on mammogram, ultrasound or breast MRI that measured \> 15 mm in diameter, is known to be malignant and is scheduled for surgery.
* Patient age \> 18 years of age.
* Have a negative pregnancy test on the first day of the study, or must be postmenopausal or surgically sterilized.

Exclusion Criteria:

* Patients will be excluded if they have a small lesion (\< 15 mm) and have undergone prior needle biopsy of the lesion (such biopsy may effectively remove all or part of the lesion and angiogenesis associated with wound healing might confound imaging results with 99mTc-NC100692).
* Patient's pregnancy is not negative on the first day of the study, or the patient is unable to complete the pregnancy test
* Patient is unable to sit on a chair for 40 minutes

Primary outcomes:
measure: Evidence of disease confirmed by surgery, or benign disease confirmed by biopsy
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Judy Boughey, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: O'Connor MK, Morrow MMB, Hunt KN, Boughey JC, Wahner-Roedler DL, Conners AL, Rhodes DJ, Hruska CB. Comparison of Tc-99m maraciclatide and Tc-99m sestamibi molecular breast imaging in patients with suspected breast cancer. EJNMMI Res. 2017 Dec;7(1):5. doi: 10.1186/s13550-017-0255-6. Epub 2017 Jan 14.
Clinical trial NCT00862589: Glucagon-Like Peptide-1 (GLP-1) Suppression of Alpha Cell Secretion in Type 2 Diabetes Mellitus (T2DM)
Official title: GLP-1 Suppression of Alpha Cell Secretion in T2DM
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperglycemia
Hyperglucagonemia
Glucose Intolerance
Keywords: glucagon
GLP-1
hyperglycemia
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2009-03-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The incretin hormone glucagon-like peptide-1 (GLP-1) has known insulinotrophic and glucagonostatic properties. However, inpatients with type 2 diabetes mellitus (T2DM)it is shown, that the beta cell sensitivity towards GLP-1 is decreased, when comparing to healthy controls. Further, these patients have decreased GLP-1 response to a meal.

The aim of this study is to elucidate if the diabetic hyperglucagonemia, seen in these patients both during fasting and in a postprandial condition, is coursed by a decreased sensitivity to GLP-1 in the diabetic alpha cell.

Ten T2DM patients and ten matched healthy control subjects will be examined on two separate days. Day 1: increasing GLP-1 infusions and Day 2: saline. During both days plasma glucose (PG) will be clamped at fasting level (FPG).

Patients with T2DM will be submitted til a Day 3, here PG will be normalized over-night by an adjustable insulin infusion, on the following day the GLP-1 infusion of Day 1 will be repeated.

The hypothesis is that these patients have decreased alpha cell sensitivity to GLP-1 as is the case with the beta cell sensitivity. This decreased sensitivity, the investigators speculate, contributes the defect suppression og glucagon and thereby to the increased PG levels seen in T2DM. Further the investigators will elucidate if this sensitivity can be increased by normalizing the diabetic PG to a normal FPG level.


Eligibility criteria: Inclusion Criteria:

* T2DM according to WHO criteria
* Written consent
* Age \> 18 years

Exclusion Criteria:

* Kidney or hepatic disease
* Treatment with insulin or glitazone

Primary outcomes:
measure: glucagon suppression
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Hare KJ, Knop FK, Asmar M, Madsbad S, Deacon CF, Holst JJ, Vilsboll T. Preserved inhibitory potency of GLP-1 on glucagon secretion in type 2 diabetes mellitus. J Clin Endocrinol Metab. 2009 Dec;94(12):4679-87. doi: 10.1210/jc.2009-0921. Epub 2009 Oct 16.
Clinical trial NCT04813289: Review of Anaesthetic Practice in Orthognathic Surgery
Official title: A Retrospective Review of Anaesthetic Practice and Intraoperative Blood Loss in Orthognathic Surgery in a Tertiary Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Maxillofacial Abnormalities
Blood Pressure
Anesthesia
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 269
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who were scheduled for orthognathic surgeries from January 2014 to March 2017 were included.Patients were excluded from the study if surgery was not done or there were missing anaesthetic records.

Brief summary: Orthognathic surgeries for maxillofacial deformities are commonly performed globally. However, they are associated with significant blood loss which can affect the surgical field and result in blood transfusion and its risks. We aim to review the different hypotensive anaesthetic practices for orthognathic surgeries, and their effects on intraoperative blood loss and transfusion requirements.


Eligibility criteria: Inclusion Criteria:

* All patients who were scheduled for orthognathic surgeries from January 2014 to March 2017

Exclusion Criteria:

* surgery was not done
* there were missing anaesthetic records

Primary outcomes:
measure: Anaesthesia technique
timeFrame: Perioperative
Secondary outcomes:
measure: Blood pressure monitoring
timeFrame: Perioperative
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
References:
Clinical trial NCT00741689: A Study to Evaluate Safety and Tolerability After Single Oral Dosing of AZD1656 in Japanese Healthy Volunteers
Official title: A Randomised, Single-Blind, Placebo-Controlled, Single-Centre, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single Ascending Oral Doses of AZD1656 in Japanese Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Japanese
healthy
volunteers
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-08-26
Enrollment: 36
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess safety and tolerability of AZD1656 after single ascending oral doses in Japanese healthy male subjects


Eligibility criteria: Inclusion Criteria:

* Healthy Japanese males aged ≥20 and ≤40 years of age
* Clinically normal physical findings and laboratory values as judged by the investigator including negative test of Hepatitis B surface antigen, antibodies to HIV virus and antibodies to Hepatitis C virus

Exclusion Criteria:

* Clinically significant illness or clinically relevant trauma, as judged by the investigator, within two weeks before the first administration of the IP
* History of psychiatric or somatic disease/condition that may interfere with the objectives of the study, as judged by the investigator.

Primary outcomes:
measure: Safety variables (AEs, blood pressure (BP), pulse, safety laboratory variables and electrocardiography (ECG)
timeFrame: Safety variables taken repeatedly during 24 hours on study day sessions
Secondary outcomes:
measure: Pharmacokinetic variables
timeFrame: Pharmacokinetic variables taken repeatedly during 24 hours on study day sessions
measure: Pharmacodynamic variables
timeFrame: Blood samples taken repeatedly during 24 hours on study day sessions
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Research Site
state: California
Study officials:
affiliation: AstraZeneca R&D Mölndal
name: Klas Malmberg, MD, PhD Prof
role: STUDY_DIRECTOR
affiliation: California Clinical Trials
name: Mark Yen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ericsson H, Roshammar D, Wollbratt M, Heijer M, Persson M, Ueda S, Leonsson-Zachrisson M, Norjavaara E. Tolerability, pharmacokinetics, and pharmacodynamics of the glucokinase activator AZD1656, after single ascending doses in healthy subjects during euglycemic clamp. Int J Clin Pharmacol Ther. 2012 Nov;50(11):765-77. doi: 10.5414/CP201747.
Clinical trial NCT04514289: To Assess and Compare the Performance Two Approach for Sentinel Lymph Node (SNLD) Biopsy for Endometrial Cancer
Official title: Endometrium Kanseri Nedeniyle Opere Olacak hastaların Sentinel Lenf Nodu Diseksiyonu değerlendirilirken kullanılan Iki farklı yöntemin kıyaslaması
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometrial Cancer
Sentinel Lymph Node
Indocyanine Green
Lead sponsor: Haseki Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-08-14
Enrollment: 106
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who have experienced endometrial cancer surgery

Brief summary: to assess and compare the performance two approaches for sentinel lymph node ( SLND) biopsy

Detailed description: Endometrial cancer is the most common gynecologic cancer. Most patients diagnosed in early stages because cancer causes remarkable symptoms such as postmenopausal or abnormal bleeding. Mostly, it does not spread, detects no metastasis. Endometrial carcinoma is surgically staged. Laparotomy or minimally invasive surgery can be performed for treatment and staging. Patients have been operated for staging surgery, have a larger surgical incision, longer operation period, more complications, more intensive care units need. Nowadays, researchers show us that there is no difference in overall survival and prognosis between surgery with or without lymphadenectomy in endometrial cancer. With all these improvements in gynecologic oncology leads us to minimally invasive surgery. Patients undergo sentinel lymph node detection by using fluorescence imaging with an indocyanine green solution. Two different ways used to assess SLND. The first group who the cervix is injected superficially with 1 mL of ICG ( indocyanine green) at 4 and 8 o'clock quadrans. The second group who ICG has injected the uterine cavity during hysteroscopy. The investigator's aim is to assess and compare the performance of two approaches for sentinel lymph node ( SLND) biopsy.

Eligibility criteria: Inclusion Criteria:

* The patient must be willing and able to provide informed consent
* The patient is willing and able to comply with the study protocol
* The patient has endometrial cancer and is performed SLND
* The patient agrees to follow-up examination out to 5-years post-treatment

Exclusion Criteria:

* The patient is not a candidate for surgery
* The patient has metastasis
* The patient has known or suspected allergies to iodine, indocyanine green( ICG)

Primary outcomes:
measure: SLN detecting rate
timeFrame: 1 year
Secondary outcomes:
measure: Overall survival
timeFrame: 5 years
measure: Disease free survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Cihan Comba
state: Sultangazi
Study officials:
affiliation: Sultangazi Haseki Training and Research Hospital
name: Cihan Comba, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT00722189: Observational Study of Efficacy and Safety of Travogen Cream and Travocort Cream in the Treatment of Mycoses
Official title: Observational Study of the Efficacy, Safety and Tolerance of Travogen Cream (Isoconazole) and Travocort Cream (Isoconazole, Diflurcortolone) in the Treatment of Patients With Local Skin Mycosis of Various Etiology and Localization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skin Mycoses
Keywords: Mycoses
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
Collaborators: name: Bayer
First posted: 2008-07-25
Enrollment: 900
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diagnosed skin mycoses

Brief summary: An assessment of the efficacy and safety of Travogen cream and Travocort cream in the treatment of local skin mycoses


Eligibility criteria: Inclusion Criteria:

* Diagnosis of skin mycosis

Exclusion Criteria:

* Allergies to study medication

Primary outcomes:
measure: Efficacy of Travogen / Travocort in the treatment of skin mycoses / Travogen Cream and Travocort Cream will be prescribed by a physician
timeFrame: Baseline to end of study
Secondary outcomes:
measure: Patient satisfaction
timeFrame: Baseline to end of study
Other outcomes:
Locations:
city: St Petersburg
country: Russian Federation
facility: Kashkin Clinical Research Mycological Institute
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: