louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05401994: Screw Retained Arch Bar Versus Conventional Erich's Arch Bar in Maxillomandibular Fixation
Official title: Screw Retained Arch Bar Versus Conventional Erich's Arch Bar in Maxillomandibular Fixation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mandibular Fractures
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2022-06-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized prospective clinical study to compare screw Retained Arch Bar and Conventional Erich's Arch Bar in Maxillomandibular Fixation

Detailed description: 2) Patients with non-pathological favorable or non-favorable fracture of mandible or maxilla that can be treated by MMF when acceptable occlusion can be obtained via bimanual reduction will be divided randomly into two equal groups: Group I: 10 patients will receive conventional Erich's arch bar. Group II: 10 patients will receive modified screw retained arch bar.

Eligibility criteria: Inclusion Criteria:

1. The patients age ranges from 18 to 50 years.
2. Patients with non-pathological favorable or non-favorable fracture of mandible or maxilla that can be treated by MMF when acceptable occlusion can be obtained via bimanual reduction.
3. Patients medically free from any systemic disease that absolutely contraindicate the surgical procedures.

Exclusion Criteria:

* 1) Edentulous ridge fracture. 2) Patients having primary and mixed dentition.

Primary outcomes:
measure: duration of surgical procedure in minutes
timeFrame: intraoperative
measure: maxillomandibular fixation stability in nominal scale(stable-unstable)
timeFrame: immediately postoperative
measure: maxillomandibular fixation stability in nominal scale(stable-unstable)
timeFrame: 4-6 weeks
measure: oral hygiene measuring with Oral Hygiene Index-Simplified (OHI-S)
timeFrame: immediately postoperative
measure: oral hygiene measuring with Oral Hygiene Index-Simplified (OHI-S)
timeFrame: 4-6 weeks
Secondary outcomes:
measure: number of iatrogenic injuries
timeFrame: intraoperative
measure: number of needle and wire stick injuries
timeFrame: intraoperative
measure: pain assessment using numeric rating scale (NRS)
timeFrame: immediately postoperative
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura university
Study officials:
References:
Clinical trial NCT05858762: Artificial Intelligence for Automated Diagnosis of Breast Cancer
Official title: Study of an Artificial Intelligence Algorithm for the Classification of Digital Tomosynthesis Breast Images for Automated Breast Cancer Diagnosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer Diagnosis
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
First posted: 2023-05-15
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women undergoing mammography

Brief summary: Mammography is a two-dimensional imaging technique which involves the tissues overlapping under the projective image; dense glandular tissue above or below the lesion can reduce the visibility of the lesion.

The trouble could be the interpretation of the image obtained which may lead to the inability to visualize a fist stage cancer and the probability that to a healthy person will be diagnosed a pathology that is not present (false positive). The introduction of an almost three-dimensional technique imaging called breast digital tomosynthesis (DBT) can overcome most limitations. In the last 5 years image analysis methods based on Artificial Intelligence (, AI) have also been massively introduced in breast cancer detection. The study is a prospective observational study based on Artificial intelligence whose the mail goal is to develop a method to identify a lesion.


Eligibility criteria: Inclusion Criteria:

* Patients who refer to the Regina Elena for diagnostic mammography tests
* Informed consent

Exclusion Criteria:

* presence of prostheses, artifacts, outcomes of a study in the breast intervention under the study

Primary outcomes:
measure: Artificial Intelligence system to detect a lesion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Università degli Studi di Napoli Federico II
city: Rome
country: Italy
facility: "Regina Elena" National Cancer Institute
Study officials:
References:
Clinical trial NCT00720291: Inflammation and Treatment of Bacterial Vaginosis Near Term
Official title: Inflammation and Treatment of Bacterial Vaginosis Near Term
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bacterial Vaginosis
Keywords: Metronidazole
BV
Pregnancy
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2008-07-22
Enrollment: 59
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Most studies demonstrate that untreated bacterial vaginosis increases the rate of preterm birth. Despite this, there is no evidence that screening and treatment of asymptomatic bacterial vaginosis nor interpregnancy treatment of endometritis decreases the subsequent rate of preterm birth. However, treatment of symptomatic bacterial vaginosis has been associated with a modest reduction in subsequent preterm birth. Potential mechanisms for this reduction include a decrease in peripheral maternal pro-inflammatory activation of the TH1 inflammatory cascade with treatment, however this direct pathway has not been elucidated. The approved treatment for bacterial vaginosis during pregnancy consists of Metronidazole 500mg BID for 7 days. A more complete understanding of the effect of Metronidazole on maternal inflammation would be useful in designing strategies to reduce the rates of preterm birth.

This study proposes to determine the effect of standard treatment of BV carriage on maternal serum markers of inflammation. This will be accomplished by giving patients with asymptomatic BV either the standard treatment of metronidazole or a placebo for 7 days. Blood will be drawn to compare levels of Interleukins 1 and 6 as well as Tumor Necrosis Factor Alpha.


Eligibility criteria: Inclusion Criteria:

* 32 weeks gestation or greater
* Multiparity
* No history of preterm birth
* English speaking
* Ability to provide informed consent
* Bacterial vaginosis by gram stain

Exclusion Criteria:

* Acute infections at any site
* Active autoimmune disease
* Current anti-inflammatory use
* Symptomatic bacterial vaginosis
* Previous adverse reaction to metronidazole
* Reports ongoing ethanol consumption

Primary outcomes:
measure: Levels of Interleukins 1 and 6 as well as Tumor Necrosis Factor Alpha
timeFrame: 3-5 days after start of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Heather Norton, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00592891: Oxygen Toxicity of HBOT in Chronic Brain Injury
Official title: Oxygen Toxicity Effects Using Los-Pressure Hyperbaric Oxygen Therapy in the Treatment of Chronic Brain Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Adult and Pediatric Chronic Cerebral Disorders
Keywords: brain injury
brain disorders
Lead sponsor: Louisiana State University Health Sciences Center in New Orleans
Sponsor class: OTHER
Collaborators: name: Harch Hyperbaric Research Foundation
First posted: 2008-01-14
Enrollment: 45
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Hypothesis: That HBOT can be toxic in the low-pressure range.

Detailed description: The study is a retrospective review of the author's experience treating chronic brain injury with HBOT, supplemented by cases communicated to the author, who developed untoward effects during or after their HBOT. The object of the study was to affirm or refute the author's general impression that there was an optimal dose of HBOT in chronic brain injury which was lower than the traditional dose applied in chronic non-central nervous system wounding. Furthermore, when this lower dosage range was exceeded and approached the traditional doses for non-CNS wounding oxygen toxicity would result. To address these impressions the study seeks to review the author's medical records and other patient/doctor communications to the author where side effects of HBOT occurred in the treatment of chronic brain injury and abstract signs, symptoms, and the dose of HBOT employed.

Eligibility criteria: Inclusion Criteria:

* Cerebral disorder of greater than one year's duration

Exclusion Criteria:

* None

Primary outcomes:
measure: Oxygen toxicity
timeFrame: After completion of hyperbaric oxygen therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Marrero
country: United States
facility: Family Physicians Center
state: Louisiana
Study officials:
affiliation: LSU School of Medicine
name: Paul G Harch, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04173091: Risk Stratification in Severe Treatment-naive, Tricuspid Regurgitation
Official title: Risk Stratification in Patients With Severe Tricuspid Regurgitation: Insights From the TRicuspid Regurgitation rEgistry (TRuE)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Functional Tricuspid Regurgitation
Keywords: tricuspid regurgitation, tricuspid valve, percutaneous treatment, right ventricle
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2019-11-21
Enrollment: 2000
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: Patients with severe functional tricuspid regurgitation diagnosed echocardiographically.

Brief summary: This registry is aimed to characterize patients with severe tricuspid regurgitation for the purpose of patient selection for interventional treatment and identify factors related to adverse outcomes.


Eligibility criteria: Inclusion Criteria:

Severe functional tricuspid regurgitation

Exclusion Criteria:

prior surgery or congenital heart diseases with involvement of the tricuspid valve

Primary outcomes:
measure: All-cause mortality
timeFrame: 1 year
measure: All-cause mortality
timeFrame: 5 years
measure: All-cause mortality
timeFrame: 10 years
Secondary outcomes:
measure: Cardiovascular mortality
timeFrame: 1 year
measure: Cardiovascular mortality
timeFrame: 5 years
measure: Cardiovascular mortality
timeFrame: 10 years
measure: Number of hospitalizations
timeFrame: 1 year
measure: Number of hospitalizations
timeFrame: 2 years
measure: Number of hospitalizations
timeFrame: 5 years
measure: Number of hospitalizations
timeFrame: 10 years
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Brunilda Alushi
city: Essen
country: Germany
facility: Contilia Heart and Vascular Centre
city: Leipzig
country: Germany
facility: Department of Internal Medicine and Cardiology, Heart Centre Leipzig
city: Munich
country: Germany
facility: German Heart Centre
city: Tel Aviv
country: Israel
facility: Rabin Medical Centre
state: Petah Tikva
Study officials:
References:
Clinical trial NCT02613091: Effect of Clemastine Fumarate on Color Vision in Healthy Controls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: volunteers
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2015-11-24
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In a1972 study in the French Annals of Pharmaceuticals, Laroche and Laroche reported that the drug clemastine has a negative effect on patients' color discrimination, which is the ability to distinguish different hues and arrange them in the correct order. In an upcoming clinical trial studying the effect of clemastine on vision outcomes, our lab aims to assess color visual performance adding assessment of color defectiveness as a clinical endpoint. Color defectiveness is the ability to see certain colors, and is commonly referred to as color-blindness. Color discrimination and defectiveness can be related, but do not always correlate. This study aims to detect the effect, if any, that clemastine has on color defectiveness in healthy controls, which could confound its use as an outcome endpoint in future clinical trials relating to clemastine.

Detailed description: Additional evaluation of pharmacokinetic data will be performed to confirm pharmacokinetic measures and correlate blood levels of drug to color performance if seen.

Eligibility criteria: Inclusion Criteria:

* Healthy control

Exclusion Criteria:

* Preexisting ophthalmologic conditions such as optic neuritis, macular star, glaucoma

Primary outcomes:
measure: Change from baseline cone contrast test score at 3 weeks
timeFrame: baseline, 3 day, 3 week
Secondary outcomes:
measure: Change from baseline Lanthany D15 score at 3 weeks
timeFrame: baseline, 3 day, 3 week
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Sandler Neurosciences Building, Neurological Clinical Research Unit
state: California
Study officials:
affiliation: UC San Francisco
name: Ari Green, MD, MCR
role: PRINCIPAL_INVESTIGATOR
References:
citation: Laroche. Modification of color vision elicited by the use of normal therapeutical dosage of some drugs. French Annals of Pharmaceuticals. 1972.
Clinical trial NCT06448091: Trial of Precision Medicine in Emergency Departments
Official title: Trial of Precision Medicine in Emergency Departments
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pharmacogenomic Drug Interaction
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Human Genome Research Institute (NHGRI)
First posted: 2024-06-07
Enrollment: 1200
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objectives of this study are to (1) test the feasibility of the clinical implementation of preemptive pharmacogenetic (PGx) testing in the emergency department (ED) and (2) determine if PGx testing (with appropriate decision support) decreases ED return visits and hospitalizations. We will conduct a randomized, controlled, pragmatic clinical trial assessing both the real-world effectiveness as well as implementation outcomes using a targeted PGx testing panel in several UF Health EDs.


Eligibility criteria: Inclusion Criteria:

1. Adults 40 years or older presenting to a participating ED
2. Receipt of a new order/prescription for a selected PGx medication (Appendix 1), with a duration greater than 7 days, during the current ED visit or within 30 days prior.
3. Documentation of at least 2 prior ED or urgent care visits within the past 12 months

Exclusion Criteria:

1. Prior clinical pharmacogenetic test results within the EHR for genes relevant for this study (Appendix 1).
2. History of hepatic or renal transplant
3. History of severe liver disease (stage Child-Pugh C) or renal disease eGFR \<15 ml/min.
4. Any medical condition that would prohibit the ability to complete the study
5. Prisoners, wards of the state, or patients being held under the Baker Act or Marchman Act
6. Life expectancy less than 6 months

Primary outcomes:
measure: ED recidivism
timeFrame: Baseline to 6 months
measure: Rate of Clinician review of PGx results
timeFrame: Return of Results to 6-months
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health Emergency Department
state: Florida
city: Jacksonville
country: United States
facility: UF Health Jacksonville Downtown Emergency Department
state: Florida
city: Jacksonville
country: United States
facility: UF Health Jacksonville North Emergency Department
state: Florida
Study officials:
affiliation: University of Florida
name: Julio D Duarte, Pharm.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00248391: The Influence of Feeding Position on Pulmonary Morbidity in Young Children
Official title: The Influence of Feeding Position on Pulmonary Morbidity in Young Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Diseases
Tonsillar Hypertrophy
Otitis Media
Dental Caries
Keywords: adenoid hypertrophy
feeding position
supine
upright
pneumonia
wheezing
otitis
adenoid
tonsil
caries
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2005-11-04
Enrollment: 2000
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL

Brief summary: Supine feeding position is associated with serous otitis media. The hypothesis is that supine feeding is associated with recurrent otitis media, tonsillar and adenoid hypertrophy and recurrent pneumonia secondary to recurrent aspiration.

Detailed description: The aim of the study is to compare two "mother and child health clinic" stations with similar socioeconomic background. Mothers from the study station will be instructed to feed their children only in an upright position since birth. In the control station mothers will continue to feed their children as usual. Pulmonary morbidity will be evaluated prospectively through the computer system of the insurance companies.

Eligibility criteria: Inclusion Criteria:

* Newborn
* Mother's compliance

Exclusion Criteria:

* Bronchopulmonary dysplasia (BPD)
* Asthma
* Cystic fibrosis
* Heart disease

Primary outcomes:
measure: pulmonary and ear-throat-nose morbidity
measure: medical costs
timeFrame: measured every 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization, Jerusalem, Israel
Study officials:
affiliation: Hadassah Medical Organization
name: Avraham Avital, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06809491: One-year Recurrence-free Survival of Melanoma Patients Eligible for a Sentinel Lymph Node Biopsy
Official title: One-year Recurrence-free Survival of Melanoma Patients Eligible for a Sentinel Lymph Node Biopsy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Melanoma, Skin
Adjuvant Treatment
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients followed at the CHRU de Nancy or at the ICL between 01/01/2019 and 31/12/2023 and who does not object to the collection of his/her data.

Brief summary: Melanoma is one of the most aggressive solid cancers, although mortality can be reduced with early treatment. Immunotherapy has transformed the prognosis of this pathology.

The sentinel lymph node technique is used to classify the severity of melanoma. It is proposed for melanomas with a Breslow thickness of 0.8 mm to 1 mm, and recommended for melanomas greater than 1 mm or with ulceration, whatever the Breslow index.

This technique is particularly useful for assessing pathology by detecting the presence of lymph node metastases. Patients with lymph node involvement (micro or macro) are eligible for adjuvant treatment.

The new recommendations suggest adjuvant immunotherapy for stages IIB and IIC (without lymph node involvement assessed by the sentinel lymph node technique). This procedure is widely used at the CHRU de NANCY.

The aim of this study is to demonstrate the value of the sentinel lymph node in assessing the risk of melanoma recurrence at one year (or more).


Eligibility criteria: Inclusion Criteria:

Major patient with a melanoma with a Breslow index greater than 0.8mm or ulcerated melanoma, non-metastatic at diagnosis,

Exclusion Criteria:

* Metastatic patient
* Minor patient
* Melanoma with a Breslow index of less than 0.8mm and not ulcerated
* Patient objecting to data collection

Primary outcomes:
measure: Death or recurrence one year after diagnosis
timeFrame: 1 year
Secondary outcomes:
measure: Overall survival
timeFrame: 4 years
measure: predictive factors of mortality or recurrence one year after diagnosis
timeFrame: 4 years
measure: the recurrence-free survival
timeFrame: 4 years
measure: complications associated with the sentinel lymph node biopsy
timeFrame: 4 years
measure: recurrence-free survival of patients over 70 years old
timeFrame: 4 years
measure: post-sentinel lymph node biopsy treatments
timeFrame: 4 years
measure: the tolerance of adjuvant treatment.
timeFrame: 4 years
Other outcomes:
Locations:
city: Vandoeuvre les Nancy
country: France
facility: CHRU Nancy
state: Grand est
Study officials:
References:
Clinical trial NCT03246191: Screening and Assessing the Risk Factors and Complications of Chronic Kidney Disease
Official title: Screening and Assessing the Risk Factors and Complications of Chronic Kidney Disease：a Cross - Sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Kidney Disease
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2017-08-11
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: subjects with 18 years or older

Brief summary: The study is an observational, cross-sectional study aimed at screening and accessing risk factors and complications for Chinese chronic kidney disease (CKD) patients. To investigate the prevalence of hypertension, cardiovascular and cerebrovascular diseases, protein energy malnutrition（PEM）, cognitive impairment and other complications in the CKD patients. To develop biomarkers of CKD.


Eligibility criteria: Inclusion Criteria:

* age≥18 years
* clinical diagnosis of CKD
* signed informed consent

Exclusion Criteria:

* End-stage renal disease(ESRD) or dialysis
* Acute kidney injure(AKI)
* history of solid organ or bone marrow transplantation
* active malignancy within 24 months prior to screening or metastatic cancer
* HIV infection or AIDS
* acute inflammation

Primary outcomes:
measure: Prevalence of CKD complications
timeFrame: baseline
measure: Biomarkers of kidney function
timeFrame: baseline
Secondary outcomes:
measure: Genetic analyses
timeFrame: baseline
measure: Questionnaire assessing cognitive function
timeFrame: baseline
measure: Questionnaire assessing depression
timeFrame: baseline
measure: Questionnaire assessing risk of malnutrition
timeFrame: baseline
measure: Questionnaire assessing dietary intake
timeFrame: baseline
measure: Questionnaire assessing quality of life
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
affiliation: Chinese PLA General Hospital
name: xiangmei chen
role: PRINCIPAL_INVESTIGATOR
References: