louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01704222: Epidemiology of Human Cytomegalovirus Excretion in the Saliva of Children Attending Nursery in France
Official title: Epidemiology of Human Cytomegalovirus Excretion in the Saliva of Children Attending Nursery in France.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Volunteers
Keywords: Children
nursery
CMV
Infection
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2012-10-11
Enrollment: 2001
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children older than 3 months and less than 6 years kept in nurseries retained, regardless of the duration of custody of the child in the manger concerned.

Brief summary: Direct DNA amplification, viral isolation and specific antibody measurement in saliva from children attending nursery in France Sample collection will be done by the pediatrician the nurse, or one of the authorized investigators of the study.

Detailed description: Salivary collection kit. 3 swab for DNA research, 1 for antibodies research and 1 for virus isolation by cell growth.

Eligibility criteria: Inclusion Criteria:

* Children older than 3 months and less than 6 years kept in nurseries retained, regardless of the duration of custody of the child in the manger concerned.

Exclusion Criteria:

* Refusal of parents (lack of consent)
* Refusal of the child according to his ability to understand
* Uninsured social security

Primary outcomes:
measure: Identification of viral shedding
timeFrame: 1 day
Secondary outcomes:
measure: Evaluate the distribution of different genotypes of strains of CMV
timeFrame: 1 day
Other outcomes:
Locations:
city: Limoges
country: France
facility: Bacteriology
Study officials:
affiliation: Limoges UH
name: Sophie ALAIN, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alain S, Garnier-Geoffroy F, Labrunie A, Montane A, Marin B, Gatet M, Grosjean J, Dufour V, Saugeras M, Postil D, Hantz S. Cytomegalovirus (CMV) Shedding in French Day-Care Centers: A Nationwide Study of Epidemiology, Risk Factors, Centers' Practices, and Parents' Awareness of CMV. J Pediatric Infect Dis Soc. 2020 Dec 31;9(6):686-694. doi: 10.1093/jpids/piz097.
Clinical trial NCT05904522: Histopathological Changes in Mycosis Fungoides
Official title: Evaluation of Histopathological Changes in the Non-lesional Skin of Stage 1A Mycosis Fungoides Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mycosis Fungoides
Keywords: mycosis fungoides
histopathology
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Biopsies will be taken from lesional and non-lesional skin of the patients in the dermatology clinic and sent to laboratory for histopathologic examination. Lesional skin of the patient will be compared with the non-lesional skin of the same patient.
Primary purpose: DIAGNOSTIC

Brief summary: Patients with mycosis fungoides stage 1A disease have patch and plaque lesions less than %10 of body skin area. Aim of the study is to compare lesional and non-lesional skin of mycosis fungoides patients, and to decide if the systemic treatment is better or local treatment is better for them. Two biopsies for each patient were taken from lesional and non-lesional skin area.

Detailed description: Patients with mycosis fungoides stage 1A disease have patch and plaque lesions less than %10 of body skin area. Aim of the study is to compare lesional and non-lesional skin of mycosis fungoides patients, and to decide if the systemic treatment is better or local treatment is better for them. Two biopsies for each patient were taken from lesional and non-lesional skin area.

Biopsies will be taken from lesional and non-lesional skin of the patients in the dermatology clinic and sent to laboratory for histopathologic examination.

Eligibility criteria: Inclusion Criteria:

* Histopathologically confirmed mycosis fungoides stage 1A patients

Exclusion Criteria:

* Mycosis fungoides patients with other stages

Primary outcomes:
measure: CD4+ T cells in epidermis
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University Hospital
Study officials:
References:
Clinical trial NCT01613222: SpO2 System Accuracy Testing With Different Sensors
Official title: SpO2 System Accuracy Testing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulse Oximetry
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2012-06-07
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: A study to test the accuracy of SpO2 sensors with various patient monitors, co-oximeters, and modules.

Detailed description: The U-TruSignal with different sensors is feasible for noninvasive and continuous SpO2 monitoring and meets the specified measurement accuracy when compared to a co-oximetry gold reference.

Eligibility criteria: Inclusion Criteria:

* Ability to provide written informed consent or have a legally authorized representative provide written informed consent
* Subjects who are 18-55 years of age
* Subjects must be willing and able to comply with study procedures
* HbCO\<3% (for smokers only)

Exclusion Criteria:

* Subject or a legally authorized representative is unable to provide written inform consent.
* Subjects that are considered morbidly obese (defined as BMI \> 39.5),
* Subjects with injuries, deformities or abnormalities that may prevent proper application of the device under test,
* Smokers with COHb levels \>3% or subjects who have smoked within two (2) days. Subjects will be screened for COHb levels of \>3% with a Masimo Radical 7 (Rainbow).
* Subjects with known respiratory conditions (uncontrolled asthma, head cold, flu, pneumonia / bronchitis, respiratory distress / respiratory or lung surgery, emphysema, COPD, lung disease),
* Subjects with known heart or cardiovascular conditions,
* Female subjects that are actively trying to get pregnant or are pregnant,
* Subjects taking blood thinners or medications with aspirin or other antiplatelet medication in them (applies only to arterial draw study),
* Subjects with Systolic blood pressure \>140mmHg,
* Subjects with Diastolic blood pressure \>100mmHg,
* Subjects with heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia

Primary outcomes:
measure: Accuracy Root Mean Square (ARMS)
timeFrame: 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Clinimark
state: Colorado
Study officials:
affiliation: GEHC
name: Jeffrey Conner
role: STUDY_DIRECTOR
References:
Clinical trial NCT01621022: Bupropion Alone or Combined With Nicotine Gum
Official title: Efficacy of Bupropion Alone and in Combination With Nicotine Gum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tobacco Dependence
Keywords: smoking cessation
tobacco dependence
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2012-06-15
Enrollment: 608
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Focus of this study was to determine if bupropion was more effective for smoking cessation when used alone or combined with nicotine gum.


Eligibility criteria: Inclusion Criteria:

* Smoke 10 or more cigarettes per day
* Motivated to quit
* No physical or mental health issues that would prevent participation
* Not pregnant or willing to prevent pregnancy during treatment

Exclusion Criteria:

* Carbon monoxide (CO) breath test score below 10 parts per million (ppm)
* Center for Epidemiologic Studies Depression Scale (CES-D) score greater than 16
* Heavy alcohol use
* History of eating disorder
* Suicidality

Primary outcomes:
measure: 7-day point prevalence abstinence measured at 6 months
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: UW Center for Tobacco Research and Intervention
state: Wisconsin
Study officials:
References:
citation: Piper ME, Federman EB, McCarthy DE, Bolt DM, Smith SS, Fiore MC, Baker TB. Efficacy of bupropion alone and in combination with nicotine gum. Nicotine Tob Res. 2007 Sep;9(9):947-54. doi: 10.1080/14622200701540820.
Clinical trial NCT03006822: Time Effect of the Pressure Release Technique Application in the Latent Myofascial Trigger Points
Official title: Time Effect of the Pressure Release Technique Application in the Latent Myofascial Trigger Points of the Levator Scapulae
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myofascial Pain Syndrome
Keywords: Myofascial Trigger Points
Liberation for Pression
Therapy Soft Tissue
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2016-12-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Latent myofascial trigger points (MTrPs) of the levator scapulae are high prevalent and may influence the neck and shoulder conditions. The pressure release is one of the most recommended manual therapy techniques.

Objective: To determine the time effect of the pressure release technique application in the latent MTrPs of the levator scapulae muscle.

Design: A three-arm (1:1:1 ratio), double-blinded, parallel, randomized clinical trial.

The manual technique than us apply, be sustained digital pressure with thumbs or with the 2nd-3rd fingers on the PGM below the pain threshold and gradually increases up to a ceiling of tissue resistance (barrier), as decreases, adds more pressure. different times of sustained pressure and the number of repetitions depending on time 30 (group 1, acts as a control), 60 (group 2) and 90 seconds (group 3) shall apply.


Eligibility criteria: Inclusion Criteria:

* Subjects with aged between 18 and 60 years.
* Subjects with presence of latent PGM levator scapulae muscle.

Exclusion Criteria:

* Pregnant.
* Subjects with spontaneous pain.
* Subjects with neck or shoulder pain.
* Subjects with musculoskeletal injuries.
* Subjects with neurological problems.
* Fibromyalgia

Primary outcomes:
measure: Pain pressure threshold (PPT)
timeFrame: Change from Baseline PPT at one week
Secondary outcomes:
measure: Strength muscle
timeFrame: Change from Baseline strength muscle at one week
Other outcomes:
measure: Range of cervical mobility
timeFrame: Change from Baseline range of cervical mobility at one week
Locations:
city: Alcala de Henares
country: Spain
facility: Grupo Fisioterapia y Dolor
state: Madrid
Study officials:
affiliation: Alcalá University (Physical Therapy and pain group)
name: Daniel Pecos-Martin, Doctor
role: STUDY_DIRECTOR
References:
citation: Pecos-Martin D, Ponce-Castro MJ, Jimenez-Rejano JJ, Nunez-Nagy S, Calvo-Lobo C, Gallego-Izquierdo T. Immediate effects of variable durations of pressure release technique on latent myofascial trigger points of the levator scapulae: a double-blinded randomised clinical trial. Acupunct Med. 2019 Jun;37(3):141-150. doi: 10.1136/acupmed-2018-011738. Epub 2019 May 7.
Clinical trial NCT06750822: Accuracy of Automatic Contusion Volume Scanning for Predicting the Incidence of Pneumonia in Patients With Thoracic Trauma
Official title: Accuracy of Automatic Contusion Volume Scanning for Predicting the Incidence of Pneumonia in Patients With Thoracic Trauma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonia
Thoracic Trauma
Keywords: AAST
AISThorax
Pneumonia
trauma
Lead sponsor: Azienda Usl di Bologna
Sponsor class: OTHER_GOV
First posted: 2024-12-27
Enrollment: 486
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study includes all the consecutive patients admitted to the ED of the institution for trauma and having a contrast whole-body CT scan performed within 6 hours from admission

Brief summary: The goal of this retrospective observational study is to evaluate the diagnostic accuracy of pulmonary contusion volume in predicting early pneumonia in patients with thoracic trauma.

The primary question we aim to answer is: What is the diagnostic accuracy of pulmonary contusion volume in predicting pneumonia within 7 days post-trauma?

Moreover, we aim to explore which is the overlap between the contused segments and those developing pneumonia.

Finally, we aim to explore relevant differences in radiomic features between contused segments that developed pneumonia.


Eligibility criteria: Inclusion Criteria:

* Admission to the ED for trauma as primary diagnosis
* Whole-body contrast CT scan performed within 6 hours from admission

Exclusion Criteria:

* Age \<18 years

Primary outcomes:
measure: 7d-pneumonia
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Maggiore Hospital Carlo Alberto Pizzardi
state: BO
Study officials:
References:
Clinical trial NCT04351022: CD38-targeted Chimeric Antigen Receptor T Cell (CART) in Relapesd or Refractory Acute Myeloid Leukemia
Official title: Pilot Study of the Efficacy and Safety of CD38 Targeted Chimeric Antigen Receptor Engineered T-Cells in the Treatment of CD38 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Acute Myeloid Leukemia
Keywords: CD38, CART, AML
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single center, open-label phase 1/2 study to evaluate the safety and efficacy of targeted CD38 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of CD38 positive relapsed or refractory acute myeloid leukemia.

Detailed description: The patients will receive infusion of CAR T-cells targeting CD38 to confirm the safety and efficacy of CD38 CAR T-Cells in relapsed or refractory acute myeloid leukemia.

Eligibility criteria: Inclusion Criteria:

* CD38 positive relapsed/refractory acute myeloid leukemia
* age 6-65 years.
* left ventricular ejection fractions ≥ 0.5 by echocardiography
* creatinine \< 1.6 mg/dL
* aspartate aminotransferase/aspartate aminotransferase \< 3x upper limit of normal
* Total bilirubin \<2.0 mg/dL
* karnofsky performance status ≥ 60
* expected survival time ≥ 3 months (according to investigator's judgement)

Exclusion Criteria:

* patients are pregnant or lactating
* uncontrolled active infection
* class III/IV cardiovascular disability according to the New York Heart Association Classification
* active hepatitis B or hepatitis C infection
* patients with HIV infection
* patients with history of seizure
* active central nervous system leukemia

Primary outcomes:
measure: Number of Adverse Events
timeFrame: 12 months
Secondary outcomes:
measure: Overall response rate (ORR)
timeFrame: 2 years
measure: Event-free survival (EFS)
timeFrame: 2 years
measure: Cumulative incidence of relapse(CIR)
timeFrame: 2 years
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital of Soochow University
name: Xiaowen Tang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cui Q, Qian C, Xu N, Kang L, Dai H, Cui W, Song B, Yin J, Li Z, Zhu X, Qu C, Liu T, Shen W, Zhu M, Yu L, Wu D, Tang X. CD38-directed CAR-T cell therapy: a novel immunotherapy strategy for relapsed acute myeloid leukemia after allogeneic hematopoietic stem cell transplantation. J Hematol Oncol. 2021 May 25;14(1):82. doi: 10.1186/s13045-021-01092-4.
Clinical trial NCT04266522: Medical Physics Direct Patient Care for the Improvement of Patient Understanding of Care
Official title: Medical Physics Direct Patient Care Initiative - Communication Intervention Study Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Neoplasm
Lead sponsor: Barbara Ann Karmanos Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-02-12
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This phase II trial studies how well medical physics direct patient care works in improving patients' understanding of their cancer treatment. Providing direct physicist-patient interactions and answering patients' questions about their cancer treatment may help patients to understand the care and therefore reduce anxiety and distress during treatment.

Detailed description: PRIMARY OBJECTIVE:

I. To evaluate whether the Medical Physics Direct Patient Care Initiative (MPDPCI) improves anxiety/distress.

SECONDARY OBJECTIVE:

II. To assess whether the MPDPCI improves patient treatment adherence and overall satisfaction.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive printed materials describing the technical aspects of their treatment.

ARM II: Patients receive printed materials as in Arm I. Patients also receive a minimum of 2 direct physicist interactions to describe the technical aspects of their treatment either immediately prior to or immediately after treatment simulation.

Eligibility criteria: Inclusion Criteria:

* Medical physicists will be eligible if they care for patients within the Gershenson Radiation Oncology Center within the Karmanos Cancer Institute and have completed the patient communication training
* Are able to read and write in English
* Are scheduled for curative radiation therapy at the Gershenson Radiation Oncology Center

Exclusion Criteria:

* NONE

Primary outcomes:
measure: Anxiety
timeFrame: 4 months
measure: Distress
timeFrame: 4 months
Secondary outcomes:
measure: Patient treatment adherence
timeFrame: 4 months
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
Study officials:
affiliation: Barbara Ann Karmanos Institute
name: Jay Burmeister, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05326022: Microcurrent Therapy and Low-Level Laser Therapy on Wound Healing
Official title: Microcurrent Therapy Versus Low-Level Laser Therapy on Post-surgical Wound Healing
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Wound Healing Delayed
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2022-04-13
Enrollment: 90
Sex: MALE
Minimum age (years): 10
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aiming to compare between the Microcurrent and Low-Level Laser Therapy on wound healing

Detailed description: The study designed to compare between the Microcurrent and Low-Level Laser Therapy on wound healing

Eligibility criteria: Inclusion Criteria:

* patient recently undergo appendectomy

Exclusion Criteria:

* patient with neurological disorders
* patient with metabolic disorders

Primary outcomes:
measure: levels of matrix metalloproteinases
timeFrame: assessed at day 3 post operative
Secondary outcomes:
measure: levels of matrix metalloproteinases
timeFrame: assessed at day 30 post operative
measure: the tissue inhibitors of metalloproteinases
timeFrame: assessed at day 3 post operative
measure: the tissue inhibitors of metalloproteinases
timeFrame: assessed at day 30 post operative
Other outcomes:
Locations:
Study officials:
affiliation: South Valley University
name: Nehad A. Abo-Zaid, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dickinson LE, Gerecht S. Engineered Biopolymeric Scaffolds for Chronic Wound Healing. Front Physiol. 2016 Aug 5;7:341. doi: 10.3389/fphys.2016.00341. eCollection 2016.
Clinical trial NCT07027722: Clinical Practices for Treating Severe Malaria Caused by P. Falciparum
Official title: Clinical Practices for Treating Severe Malaria Caused by P. Falciparum
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malaria, Falciparum
Plasmodium Falciparum
Antimalarials
Artemisinins
Treatment Outcome
Drug Therapy, Combination
Retrospective Studies
Hospitalization
Lead sponsor: Centre Hospitalier de Saint-Denis
Sponsor class: OTHER
First posted: 2025-06-18
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of adult patients (aged 18 years and older) who were hospitalized in one of the three participating centers over the past five years for Plasmodium falciparum malaria with a parasitemia level greater than or equal to 4%. These patients may or may not have presented with clinical signs of severity, and their treatment will have included either artemisinin-based combination therapy (ACT) or intravenous artesunate. Participants will be selected retrospectively from medical records based on these criteria.

Brief summary: This study looks at how doctors in three hospitals in France treat patients with a serious form of malaria caused by Plasmodium falciparum. It focuses on cases where the level of malaria parasites in the blood is 4% or higher. The study will compare how often a type of medicine called ACT (artemisinin-based combination therapy) is used on its own instead of the usual first-choice treatment (intravenous artesunate), and whether ACT works just as well. It will also check how well patients recover, whether they have complications, and how long they stay in the hospital.


Eligibility criteria: Inclusion Criteria:

* Adult patients aged 18 years or older.
* Diagnosis of Plasmodium falciparum malaria with a parasitemia level ≥ 4%.

Exclusion Criteria:

- Patients under 18 years old

Primary outcomes:
measure: Proportion of patients treated with artemisinin-based combination therapy (ACT) alone for Plasmodium falciparum malaria with parasitemia ≥4%.
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Denis
country: France
facility: France
Study officials:
References: