louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04429594: Study of the Incidence of SARS-CoV-2 Infection (COVID-19)
Official title: Study of the Incidence of SARS-CoV-2 Infection in the Alpes-Maritimes Department by Analysis of the Specific Humoral and Cellular Response During Deconfinement
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronavirus Infections
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2020-06-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This is a prospective observational cohort study that will define the prevalence and incidence of CA-SARS-Cov2 infection using serological and PCR tests in a group of subjects during deconfinement. The team wishes to include approximately 1000 subjects in this study.

The health crisis through containment has also created unprecedented environmental conditions with the very clear decrease in economic activities and a consequent decrease in exposure to the main air pollutants. The aim is therefore to carry out a case-control study in which each subject will be his or her own control in unexposed condition (to PM2.5, PM10, NO...) then exposed (after the recovery of economic activity and the usual levels of air pollutants) and to measure the impact of these pollutants on the immune system and epigenetic markers taking into account seasonality.

The occurrence of infectious, cardiovascular, allergic and autoimmune events will then be measured according to the immunological profiles measured at inclusion.


Eligibility criteria: Inclusion Criteria:

* Any major subject, voluntary, exposed to the public from 11 May 2020 informed of the study by partner institutions (Departmental Council 06), affiliated to a social security scheme,

Exclusion Criteria:

* Subject protected by law under tutorship or guardianship, or who cannot participate in a clinical study under the terms of Article L. 1121-16 of the French Public Health Code

Primary outcomes:
measure: positive serologies
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: University Nice Hospital
Study officials:
References:
Clinical trial NCT02080494: Tranexamic Acid in Orthopaedic Trauma Surgery
Official title: Tranexamic Acid in Orthopaedic Trauma Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Blood Loss
Trauma
Fracture
Surgery
Keywords: tranexamic acid
orthopaedic trauma
pelvic fracture
hip fracture
femur fracture
blood loss
Lead sponsor: University of Tennessee
Sponsor class: OTHER
First posted: 2014-03-06
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Tranexamic acid is an antifibrinolytic drug that has been used to decrease post-operative blood loss. This study is a prospective, randomized controlled trial investigating the use of tranexamic acid in fracture surgery around the hip and knee, in which significant blood loss (\>300mL) is expected.

The hypothesis of this study is that tranexamic acid will be associated with a decrease in post-operative blood loss, as well as a decreased need for allogenic blood transfusion, in patients who have fracture surgery around the hip and knee.


Eligibility criteria: Inclusion Criteria:

* Patients with isolated fractures of the pelvic ring, acetabulum, femur or tibia that will require open reduction and internal fixation
* Expected blood loss is greater than 300 mL
* Age ≥ 18
* Skeletal maturity

Exclusion Criteria:

* Pregnant or breastfeeding
* Patients taking oral contraceptives
* Contraindication to venous thromboembolic event (VTE) prophylaxis (intracranial, intrathoracic, intra-abdominal bleeding or spine fractures)
* Patients requiring operative intervention for other injuries (orthopaedic or non-orthopaedic)
* Known hypercoagulable state including history of prescribed anti-coagulation (warfarin, plavix, low molecular weight heparin)
* Renal Insufficiency (creatinine greater than 1.5mg/dL)
* Open fractures

Primary outcomes:
measure: hemoglobin value
timeFrame: through postoperative day four
Secondary outcomes:
measure: hematocrit value
timeFrame: through postoperative day four
measure: number of units of allogenic blood transfused
timeFrame: through postoperative day four
Other outcomes:
Locations:
city: Chattanooga
country: United States
facility: Erlanger Health System
state: Tennessee
Study officials:
affiliation: UTCOM Chattanooga / Erlanger Health System
name: Dirk W Kiner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06470594: Superficial and Deep Endometriosis: Role of Systemic Inflammation as a Marker of Clinical, Surgical, and Reproductive Outcomes
Official title: Superficial and Deep Endometriosis: Role of Systemic Inflammation as a Marker of Clinical, Surgical, and Reproductive Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endometriosis
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2024-06-24
Enrollment: 138
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women with chronic pelvic pain and/or infertility with a sonographic or MRI ascertained suspicion of endometriosis.

Brief summary: Primary aim of this study is to evaluate the change in systemic inflammation parameters after surgery for superficial, ovarian or deep endometriosis. Secondary objectives focus on correlating these parameters to clinical outcomes, in patients with pelvic pain, and reproductive outcomes, in women desiring offspring.

Participants already scheduled for surgery as part of their endometriosis care will be followed regarding the abovementioned outcomes after calculation of pre and postsurgical systemic inflammation markers (neutrophil to lymphocyte ratio; platelet to lymphocyte ratio and lymphocyte to monocyte ratio)


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 45 years.
* Postoperative follow-up of at least 12 months;
* Signature of informed consent regarding laparoscopic surgical treatment.
* Signature of informed consent to the processing of personal data duly documented by medical records.

Exclusion Criteria:

* Failure to sign informed consent for laparoscopic surgical treatment
* Histologic diagnosis of borderline tumor and/or ovarian carcinoma and/or mucinous cystadenoma and/or germ cell tumor or other malignancy of the genital tract
* postoperative follow-up of less than 12 months;
* documented history of inflammatory, rheumatologic, or immunologic disease; and
* failure to provide informed consent for personal data processing.

Primary outcomes:
measure: Neutrophil to lymphocyte ratio
timeFrame: Measured before and after (24 to 72 hours) surgery
Secondary outcomes:
measure: Platelet to lymphocyte ratio
timeFrame: Measured before and after (24 to 72 hours) surgery
measure: Lymphocyte to monocyte ratio
timeFrame: Measured before and after (24 to 72 hours) surgery
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: University of Campania Luigi Vanvitelli
Study officials:
References:
Clinical trial NCT04103294: Measuring Cowpea Consumption in Young Children and Pregnant Women in Ghana
Official title: Measuring Cowpea Consumption in Young Children and Pregnant Women in Ghana
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Exposure
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: College of Health Sciences, University of Ghana, Legon
name: Project Peanut Butter, Ghana
name: Michigan State University
First posted: 2019-09-25
Enrollment: 47
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Current dietary assessment methods rely on self-report food intake such as food frequency questionnaires, 24-hr dietary recall, or diet diaries, and the prevalence of misreporting with these tools is estimated at 30-88%.A reliable and convenient way to measure the quantity of cowpea consumed by an individual. The hope is to identify a novel set of dietary biomarkers that will measure cowpea consumption, be free from participant recall bias, and serve to quantify legume intake. A total of 40 subjects, 20 children (9-21 months) and 20 pregnant women (\>18 yr) will consume 3 distinct daily intake dosages of cooked cowpeas with the daily intake increased every 5 days. Urine samples will be collected 3 times during each 5-day period and blood spots will be collected during a washout period and at the end of the final 5-day period. Urine samples will undergo metabolite detection via ultra-performance liquid chromatography tandem mass spectrometry in positive and negative ion mode. Peaks are quantified using area-under-the-curve (AUC) and each metabolite is quantified in terms of its median-scaled relative abundance for the metabolite across the entire data set. A repeated measures 2-way ANOVA will be used to compare cowpea metabolite abundances over time and with respect to variation in an individual baseline levels.


Eligibility criteria: Inclusion Criteria:

* Healthy children between the ages of 9-21 months and pregnant women \> 18 years of age and between 20-25 weeks of gestation.

Exclusion Criteria:

* Children with acute malnutrition, congenital abnormalities, chronic debilitation disease such as heart disease, cerebral palsy, or HIV infection. For the pregnant women they should also be free from acute malnutrition, without known complications such as gestational diabetes, pre-eclampsia, gestational diabetes, or hypertension

Primary outcomes:
measure: Metabolomic profiling of Urine and Plasma
timeFrame: 20 days
Secondary outcomes:
Other outcomes:
Locations:
city: Accra
country: Ghana
facility: College of Health Sciences, University of Ghana
state: Mion And Nanton District
Study officials:
affiliation: Washington University School of Medicine in St. Louis
name: Mark Manary, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02506894: Fetal Middle Cerebral Artery Doppler in Preterm Births Receiving Magnesium Sulfate for Neuroprotection
Official title: Fetal Middle Cerebral Artery Doppler in Preterm Births Receiving Magnesium Sulfate for Neuroprotection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Preterm Birth
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2015-07-23
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Two groups of women with preterm labor will be included. One will receive magnesium sulfate for neuroprotection and the other will receive placebo. Fetal middle cerebral artery Doppler indices will be measured before and after intake of either magnesium sulfate or placebo to find if any significant changes occur in fetal cerebral blood flow.

Detailed description: The study will include women with preterm labor with gestational age less than 32 weeks. women will be randomized to receive either magnesium sulfate (loading dose 6 g over 20 minutes followed by maintenance dose of 1 g/hour for 24 hours), or placebo in the form of sodium chloride solution 0.9% over 24 hours. Fetal middle cerebral artery Doppler indices \[Peak systolic velocity (PSV), Pulsatility index (PI), and resistance index (RI)\] will be recorded before and after treatment in both groups. Results of Doppler indices will be compared between both groups and before and after intake of magnesium sulfate to find out if middle cerebral artery Doppler of the fetus can explain the mechanism behind the use of magnesium sulfate for fetal neuroprotection in preterm births.

Eligibility criteria: Inclusion Criteria:

* pregnant women with preterm labor
* gestational age less than 32 weeks
* singleton pregnancy

Exclusion Criteria:

* contraindication or hypersensitivity to magnesium
* preeclampsia
* multiple pregnancy
* intake of magnesium sulfate in this pregnancy before

Primary outcomes:
measure: changes in fetal middle cerebral artery Doppler indices
timeFrame: 3 months
Secondary outcomes:
measure: maternal adverse effects of magnesium sulfate
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: Ghada Abdel Fattah Abdel Moety, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02983994: Errors in the Use of Turbuhaler and Spiromax Devices Patients With Asthma
Official title: Errors in the Use of Turbuhaler and Spiromax Devices Patients With Asthma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: asthma, devices
Lead sponsor: Andalusian Network for Design and Translation of Advanced Therapies
Sponsor class: OTHER
First posted: 2016-12-06
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed as asthma with indication for treatment with an inhaled steroid (IC) and long-acting beta agonist (LABA), over 18 years of age, will be consecutively included according to the criteria of the GINA 2015 (Global Strategy for Asthma Management and Prevention), who have never used dry-powder inhalers, and whose doctor has prescribed one of the inhalation systems to be studied in the normal practice of the consultation. Patients will be recruited consecutively to complete the sample size established with each type of device, in each of the participating centers.

Brief summary: The aim of the study is to evaluate the errors that may occur during inhalation of two devices in patients with asthma, as well as to study whether it relates to the degree of control of patient symptoms and the degree of compliance of medication symptoms. Finally, we also want to study the degree of patient satisfaction with each of the inhalers studied


Eligibility criteria: Inclusion Criteria:

* Diagnosis of asthma with treatment indication with CI + LABA according to GINA 2015 guide and in dry powder device.
* Over 18 years.
* Patient in stable phase without having had exacerbations in the 3 months previous to the Inclusion in the study

Exclusion Criteria:

* Presence of relevant respiratory disease other than asthma (including COPD).
* Refusal to participate in the study and sign informed consent or inability to To give informed consent.
* Patients who have previously been treated with inhaled dust devices dry.

Primary outcomes:
measure: The effectiveness of inhaler management.
timeFrame: two months
Secondary outcomes:
Other outcomes:
Locations:
city: Cadiz
country: Spain
facility: Hospital Universitario Puerta del Mar
city: Malaga
country: Spain
facility: Hospital Regional de Málaga
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
Study officials:
References:
Clinical trial NCT05048394: Teleoperation Experimental Comparison With Able-bodied Subjects
Official title: Teleoperation Experimental Comparison With Able-bodied Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amputation; Traumatic, Arm, Upper
Lead sponsor: Point Designs
Sponsor class: INDUSTRY
Collaborators: name: University of Colorado, Boulder
name: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
First posted: 2021-09-17
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DEVICE_FEASIBILITY

Brief summary: To compare the use of the semi-autonomous control algorithm (condition 1) with the standard of care myoelectric system used with the TASKA prosthetic hand (condition 2). Able bodied subjects will enroll in a laboratory based experimental session at the University of Colorado at Boulder. Subjects will be fitted with a by-pass prosthesis which enables the able-bodied subject to control the prosthetic hand using the myoelectric signals on their able limb. A TASKA prosthetic hand will be sensorized using the Point Touch technology. In a randomized order, the subjects will perform functional tasks evaluating dexterity and assistance with prolonged gross motor movement using each experimental condition. Then, a direct comparison can be made across subjects for the semi-autonomous control algorithm and the standard of care myoelectric system used in the TASKA prosthetic hand.


Eligibility criteria: Inclusion Criteria:

* Able-bodied subject
* Fluent in English
* Age of 18 years or greater

Exclusion Criteria:

* Significant cognitive deficits as determined upon clinical evaluation
* Significant neurological deficits as determined upon clinical evaluation
* Significant physical deficits of the residual limb impacting full participation in the study as determined upon clinical evaluation

Primary outcomes:
measure: Transfer Success Rate in a Fragile Box and Blocks Task
timeFrame: Day 1 (1 hour)
Secondary outcomes:
measure: Ball Drops in a Holding Task
timeFrame: Day 1 (1 hour)
Other outcomes:
Locations:
city: Boulder
country: United States
facility: University of Colorado Boulder
state: Colorado
Study officials:
References:
Clinical trial NCT00576394: Aggressive Versus Moderate Glycemic Control in Diabetic Coronary Bypass Patients
Official title: Impact of Aggressive Versus Moderate Glycemic Control on Clinical Outcomes Following Coronary Artery Bypass Graft Surgery in Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Glycemic Control
Keywords: Glucose, Insulin
Lead sponsor: American Heart Association
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2007-12-19
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: entGlycemic control has been found to improve clinical outcomes following Coronary Bypass Surgery. This study tests the hypothesis that obtaining tighter glycemic control(80-120mg/dl) as opposed to more moderate control (120-180mg/dl) will further improve outcomes.

Detailed description: 150 diabetic patients will be randomized to achieve aggressive glycemic control (80-120mg/dl) vs moderate control (120-180mg/dl) using intravenous insulin infusions beginning at anesthetic induction and continuing for 18 hours following surgery.

Eligibility criteria: Inclusion Criteria:

* All diabetic patients undergoing Coronary Bypass Surgery

Exclusion Criteria:

* Patients with hepatic and renal failure

Primary outcomes:
measure: Incidence of Hypoglycemia
timeFrame: 24 hours following surgery
Secondary outcomes:
measure: free fatty acid levels
timeFrame: 24 hours following surgery
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
References:
citation: Lazar HL, McDonnell MM, Chipkin S, Fitzgerald C, Bliss C, Cabral H. Effects of aggressive versus moderate glycemic control on clinical outcomes in diabetic coronary artery bypass graft patients. Ann Surg. 2011 Sep;254(3):458-63; discussion 463-4. doi: 10.1097/SLA.0b013e31822c5d78.
Clinical trial NCT02883894: Interest of Dosage of Anti-PB230, Anti-PB180 and Cytokines for Monitoring of Patients Suffering From Bullous Pemphigoid
Official title: Interest of Dosage of Anti-PB230, Anti-PB180 and Cytokines for Monitoring of Patients Suffering From Bullous Pemphigoid
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bullous Pemphigoid
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2016-08-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with bullous pemphigoid.

Brief summary: Bullous pemphigoid is the most common subepidermal autoimmune blistering disease of the skin in European countries, including France.

Immunologically, BP is characterized by the production of autoantibodies directed against two major components of the hemidesmosome, BP180 and BP230.

The anti-BP180 autoantibody is detected in 79-93% of cases of bullous pemphigoid and its serum level at diagnosis have been correlated with disease activity. The anti-BP230 autoantibody is detected in 57%-63% of bullous pemphigoid cases and its score at diagnosis did not correlate with disease activity.

Up to now, no clinical or immunologic factors have been identified to predict outcome of patients with good or poor prognosis bullous pemphigoid as defined by long complete remission off therapy and recurrent disease requiring maintenance therapy for years. The usefulness of BP180 or BP230 ELISA scores for monitoring BP patients during treatment also remains unclear.

Detailed description: Aim of the study were :

To study association between the serum level of cytokines (IL-17 and IL-23) and of the protease MMP-9 and the relapse of bullous pemphigoid.

Eligibility criteria: Inclusion Criteria:

* patients with bullous pemphigoid
* patients not yet receiving treatment for bullous pemphigoid
* aged \> 18 years

Exclusion Criteria:

- Patients with relapse of bullous pemphigoid

Primary outcomes:
measure: Relapse of bullous pemphigoid.
timeFrame: Month 12
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Chu de Reims
Study officials:
References:
citation: Plee J, Le Jan S, Giustiniani J, Barbe C, Joly P, Bedane C, Vabres P, Truchetet F, Aubin F, Antonicelli F, Bernard P. Integrating longitudinal serum IL-17 and IL-23 follow-up, along with autoantibodies variation, contributes to predict bullous pemphigoid outcome. Sci Rep. 2015 Dec 14;5:18001. doi: 10.1038/srep18001.