louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06854263: CLARITY Study - PMCF Study
Official title: ProspeCtive, muLti-site, Single-group, Open-lAbel Study to Evaluate the Safety and Performance of RADSAFE® Inks for radiaTion therapY Site Marking (CLARITY Study)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Radiation Therapy
Lead sponsor: Laboratoires BIOTIC Phocea
Sponsor class: INDUSTRY
First posted: 2025-03-03
Enrollment: 119
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: Adult patients with cancer requiring skin marking for radiotherapy treatment

Brief summary: In the context of the Post-Market Clinical Follow-up (PMCF), this study aimed at evaluating the safety and performance of the RADSAFE® inks in the marking of the radiation field.


Eligibility criteria: Inclusion Criteria:

Male or female ≥18 years old, Cancer patient requiring radiotherapy, Patient requiring medical tattoo for treatment alignment, Intact skin at site of standard radiotherapy tattoos, ECOG performance status ≤2 (Karnofsky ≥60%), Able to provide written informed consent, Affiliated patient or beneficiary of a social security scheme.

Exclusion Criteria:

Previous medical tattoo of the targeted zone of treatment Known allergy to pigment ingredients, Infected or diseased skin, past or present, Affected organs close to the skin (eyes), Hypertrophic scars at site of radiotherapy tattoos, Carrying cardiac implant, Patient with blood clotting disorders, No consent to study participation, Under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision, An existing medical condition that, in the opinion of the Investigator, may put the subject at risk or compromise their participation in the study, Psychiatric illness/social situations that would limit compliance with study requirements, Females who are pregnant, lactating, or unwilling to use adequate birth control for the duration of the study, Personal objection to medical tattooing, Participation to another drug or medical device clinical interventional study that may interfere with the clinical investigation objectives.

Primary outcomes:
measure: Evaluate the performance of RADSAFE® for radiation therapy site skin-marking
timeFrame: From enrollment to the end of treatment at 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01775163: Effect of Exercise-Induced Weight Loss on Energy Metabolism
Official title: E-MECHANIC Ancillary Study: Effect of Exercise-Induced Weight Loss on Energy Metabolism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolism
Weight Loss
Keywords: Energy
Metabolism
Weight Loss
Exercise
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2013-01-24
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and Women enrolled in E-MECHANIC

Brief summary: The E-MECHANIC Ancillary Study will measure changes in 24-hour energy expenditure and spontaneous physical activity in a subset of 60 obese individuals enrolled in the main study. We aim to determine if changes in energy metabolism might explain why people don't lose the expected amount of weight in an exercise program.

Detailed description: This is an ancillary study to E-Mechanic, which is an National Institutes of Health study in 198 individuals with the objective to understand why certain people fail to lose weight in exercise programs. In E-Mechanic changes in body weight, body composition, energy intake and energy expenditure are measured before and after 3 different exercise programs of 24 weeks in duration. The 3 exercise programs being compared are self-directed exercise, low dose exercise and high dose exercise. The goal of this ancillary study is to undertake comprehensive assessments of energy metabolism in a metabolic chamber in a group of 60 obese individuals enrolled in the main study. We will compare differences in the changes in 24h energy expenditure and spontaneous physical activity between the 3 exercise programs. We will also test if changes in energy metabolism might explain why people don't lose the expected amount of weight after 24 weeks of exercise.

Eligibility criteria: Inclusion Criteria:

* Individuals enrolled in the E-MECHANIC main study (NCT#01264406) with a body mass index (BMI) greater than or equal to 30 kg/m2.

Exclusion Criteria:

* Not enrolled in the E-MECHANIC main study (NCT#01264406).
* Have a body mass index (BMI) less than 30 kg/m2.

Primary outcomes:
measure: Change in 24h energy expenditure
timeFrame: 24 weeks
Secondary outcomes:
measure: Metabolic adaptation in 24h energy expenditure
timeFrame: 24 weeks
Other outcomes:
measure: Sleeping energy expenditure
timeFrame: 24 weeks
measure: Spontaneous physical activity
timeFrame: 24 weeks
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Leanne M Redman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lam YY, Redman LM, Smith SR, Bray GA, Greenway FL, Johannsen D, Ravussin E. Determinants of sedentary 24-h energy expenditure: equations for energy prescription and adjustment in a respiratory chamber. Am J Clin Nutr. 2014 Apr;99(4):834-42. doi: 10.3945/ajcn.113.079566. Epub 2014 Feb 5.
Clinical trial NCT06791863: Visceral Fat Area as a Prognostic Biomarker in Clear Cell Renal Cell Carcinoma: A Multicenter Study on Postoperative Survival
Official title: Visceral Fat Area as a Prognostic Biomarker in Clear Cell Renal Cell Carcinoma: A Multicenter Study on Postoperative Survival
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ccRCC
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2025-01-24
Enrollment: 1030
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: patients with clear cell renal cell carcinoma (ccRCC) who underwent radical or partial nephrectomy

Brief summary: This retrospective study included 1030 patients with clear cell renal cell carcinoma (ccRCC) who underwent radical or partial nephrectomy at Wuhan Union Hospital from 2014 to 2023.


Eligibility criteria: Inclusion Criteria:

1. primary clear cell renal cell carcinoma confirmed by histopathology;
2. patients≥18 years;
3. availability of preoperative abdominal computed tomography (CT) data;
4. patients with partial or radical nephrectomy.

Primary outcomes:
measure: overall survival (OS)
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wuhan Union Hospital
state: Hubei
Study officials:
References:
Clinical trial NCT03020563: Does Liposomal Bupivacaine Provide Improved Pain Management for ORIF of Midshaft Clavicle Fractures?
Official title: Does Liposomal Bupivacaine Provide Improved Pain Management for ORIF of Midshaft Clavicle Fractures?
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Clavicle Fracture
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2017-01-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine whether liposomal bupivacaine wound infiltration decreases pain scores and narcotic use when compared to bupivacaine alone after open reduction internal fixation of midshaft clavicle fractures.


Eligibility criteria: Inclusion Criteria:

* Mid-shaft Clavicle Fracture treated with ORIF

Exclusion Criteria:

* Unable to be contacted for 72 hours post surgery
* Other concurrent surgical procedures
* Chronic narcotic user

Primary outcomes:
measure: Visual Analogue Pain Scale Averages between the two treatments
timeFrame: 72 hours post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References:
Clinical trial NCT02751463: 18850 - Human Photoallergy Test
Official title: Human Photoallergy Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-04-26
Enrollment: 54
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: OTHER

Brief summary: To evaluate the potential of a test material to produce a photoallergic response.


Eligibility criteria: Inclusion Criteria:

* be male or female between the ages of 18 and 60 inclusive;
* be lightly pigmented (Fitzpatrick Skin Type I, II, III);
* have read and signed the written Informed Consent Form and have completed a Health Insurance Portability and Accountability Act (HIPAA) Authorization Form in conformance with 45CFR Parts 160 and 164;
* be in general good health as determined by the subject's medical history and in the discretion of the investigator.

Exclusion Criteria:

* have a visible sunburn;
* have a history of sun hypersensitivity/photosensitivity or photosensitive dermatoses;
* have a known hypersensitivity or allergy against any of the active and non-active ingredients of the investigational products.
* subjects who are employees of the CRO and/or Bayer or is a household member of an employee

Primary outcomes:
measure: Intensity of skin reactions is evaluated by 5 point grading scale
timeFrame: Up to 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Piscataway
country: United States
state: New Jersey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06797063: Breastfeeding Education Support Tool
Official title: Breastfeeding Education Support Tool
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breastfeeding, Exclusive
Infant Development
Infant Growth
Breast Feeding
Keywords: breastfeeding
India
infant feeding
peer counselors
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: KLE University Jawaharlal Nehru Medical College
name: Benten Technologies, Inc.
First posted: 2025-01-28
Enrollment: 1152
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The proposed project seeks to evaluate the effectiveness and implementation of the Breastfeeding Education Support Tool for Baby (BEST4Baby) intervention, an mHealth-supported community-based peer counselor breastfeeding intervention for mothers in India. Given that rates of optimal infant feeding practices have remained stagnant over the past two decades in India, and that India is the most populous country and icontributes one-fifth of all global live births, this project could have major global health implications if the intervention is found to improve maternal breastfeeding practices and infant clinical outcomes. The project will also provide evidence needed to adopt BEST4Baby nationally and in other low resource communities.


Eligibility criteria: Inclusion Criteria:

* at least 18 years of age,
* pregnant and 20-27 weeks of gestation at study enrollment,
* singleton pregnancy,
* no major antepartum complications,
* living in a research site,
* planning to deliver in the cluster area,
* capable of giving informed consent,
* willing to be visited by a PC and research personnel for up to 12 months post-delivery.

Exclusion Criteria:

comorbidities impacting breastfeeding,

- severe psychological illness that could interfere with consent and study participation. Following a live birth, participants will remain eligible to continue in the study unless the mother or infant experiences: illness or clinical complications warranting prolonged hospitalization, stillbirth, low birth weight (\< 2500 g), congenital abnormality, or neonatal death.

Primary outcomes:
measure: exclusive breastfeeding at 6 months
timeFrame: 6 months
measure: Infant growth velocity
timeFrame: 6 months and 12 months
measure: Infant cognitive development
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Belgaum
country: India
facility: KLE Univeristy
state: Karnataka
Study officials:
References:
Clinical trial NCT02569463: Low-dose IL-2 ( Interleukin-2) Treatment in Macrophage Activation Syndrome（MAS）
Official title: Safety and Efficiency Study of Low-dose IL-2 Treatment in Macrophage Activation Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Macrophage Activation Syndrome
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2015-10-06
Enrollment: 6
Sex: ALL
Minimum age (years): 16
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: The investigators evaluate the effectiveness and safeness of low-dose Recombinant Human Interleukin-2 （rhIL-2） for MAS.

Detailed description: Autoimmune-associated macrophage activation syndrome (MAS), also known as secondary hemophagocytic lymphohistiocytosis (HLH), is a rapidly progressing life-threatening disease. VP16 (Etoposide) is a well-known standard therapy, but is associated with substantial adverse effects, especially myelosuppression and infections , while steroids and ciclosporin (CSA) are not always efficient in this disease.

The investigators hypothesized that low- dose IL-2 could be a novel therapy in MAS. This clinical study will test the efficacy and safety of low dose IL-2 treatment in MAS. The investigators perform a single-centre pilot trial with rhIL-2 in MAS. The investigators evaluate the effectiveness and safeness of low-dose IL-2 for MAS.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Macrophage Activation Syndrome（MAS）
* MAS secondary to autoimmune disease, such as Adult onset still's disease (AOSD), juvenile rheumatoid arthritis (JRA) or Systemic Lupus Erythematosus (SLE).

Exclusion Criteria:

* Primary MAS
* Secondary to neoplasia, lymphoma and virus infection
* pre-treatment with Cyclosporine A
* relevant cardiac, pulmonary, neurologic or psychiatric disease
* life-Vaccination within 4 weeks before begin with study medication
* pregnant or breast-feeding
* weight under 45kg or more than 80kg

Primary outcomes:
measure: Disease activity on the HScore (a Score for the Diagnosis of Reactive Hemophagocytic Syndrome)
timeFrame: 1month
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Rheumatology and Immunology, Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Department of Rheumatology and Immunology,Peking University People's Hospital
name: Zhanguo Li
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02304835: Feasibility of a Self-performed Urinary Test for the Follow-up on Medical Abortion
Official title: Feasibility of a Self-performed Urinary Test for the Follow-up on Medical Abortion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abortion; Attempted, Medical
Lead sponsor: Nordic Pharma SAS
Sponsor class: INDUSTRY
First posted: 2014-12-02
Enrollment: 322
Sex: FEMALE
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: Women asking for medical abortion

Brief summary: This study was a national, longitudinal, prospective, observational survey, carried out in metropolitan France, with a sampling of 21 birth control centres.

The aim of this study was to assess, in real life conditions, the benefit of a urinary semi-quantitative test (hCG Duo 5-1000) in the follow-up of medical abortion by analysing the concordance between qualitative results from the urinary test and quantitative values from the beta-hCG blood measurement.


Eligibility criteria: Inclusion Criteria:

* Adult women (18 years old or more), pregnant the day of the medical examination and asking for medical abortion.
* Patients agreeing to participate in the study after have been informed orally by the physician and given the information sheet.
* Informed patients accepting the computer processing of their medical data and their right of access and correction.

Exclusion Criteria:

* Patients with more than 49 Days of Amenorrhea (DA) for private practice and 63 DA for hospital practice.
* Patients with contraindications to medical abortion.
* Patients with severe and progressive disease.
* Patients unable to complete a questionnaire.
* Patients refusing to participate in the study.

Primary outcomes:
measure: concordance between qualitative results from the urinary test and quantitative values from the beta-hCG blood measurement.
timeFrame: At the follow-up at 2-3 weeks after inclusion
Secondary outcomes:
measure: Acceptability of the urinary semi-quantitative test by the patient
timeFrame: at the follow up at 2-3 weeks after the inclusion
Other outcomes:
Locations:
city: Paris
country: France
facility: Cabinet Médical
Study officials:
affiliation: Cabinet Médical
name: Danielle HASSOUN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03426735: Study of Iodine Contrast Media Extravasation
Official title: Multicenter Study to Evaluate the Effectiveness of Dry Heat in the Extravasations of Iodinated Contrast.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contrast Media Extravasation
Keywords: Iodine
Iodized
Computerized Tomography
Extravasation
contrast media
Lead sponsor: Hospital de Sant Pau
Sponsor class: OTHER
Collaborators: name: University of Barcelona
First posted: 2018-02-08
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the best intervention after the extravasation of the iodinated contrast medium out of a vessel into the surrounding tissues.

Detailed description: The risk of intravenous extravasation of iodinated contrast media has a relatively low incidence, although the increase in requests for computed tomography scans where it can manage contrasts with a large volume, high osmolality, high-speed injection pumps and even with an added electrical load, has caused an increase in this risk and its complications.

When there is an extravasation of iodinated contrast medium, in most published recommendations and guidelines advise local conservative measures, but there is no consensus on whether cold or heat should be applied as the first intervention to minimize the consequences and favour a rapid resolution.

This study aims to evaluate the effectiveness of the application of heat in the extravasations of iodinated contrast, providing the necessary evidence to determine the best cure that can be applied in the current circumstances of administration, by injection pumps at high speeds and large volumes.

Eligibility criteria: Inclusion Criteria:

* Computed tomography procedure.
* Administration of the contrast medium with injection pump between 1,5 and 8 ml/s.
* Peripheral venous access in the arms or legs.

Exclusion Criteria:

* Administration of the contrast medium with central venous access.
* Renal insufficiency.
* Iodine allergy.
* Immediate acute complications.

Primary outcomes:
measure: Time resolution the swelling and pain.
timeFrame: 24-48 hours past
Secondary outcomes:
Other outcomes:
Locations:
city: Hospitalet de Llobregat
country: Spain
facility: Hospital General de l´Hospitalet
state: Barcelona
city: Sant Cugat del Vallès
country: Spain
facility: Health Diagnostic General Catalunya
state: Barcelona
city: Sant Joan Despí
country: Spain
facility: Hospital de Sant Joan Despí Moisès Broggi
state: Barcelona
city: Barcelona
country: Spain
facility: Radiología del Parc Salut Mar
city: Barcelona
country: Spain
facility: Health Diagnostic Teknon
city: Barcelona
country: Spain
facility: Servicio Radiologia Clínica Sagrada Familia
city: Barcelona
country: Spain
facility: Health Diagnostics Sagrat Cor
city: Barcelona
country: Spain
facility: Centre de Diagnòstic per la Imatge Clínic
city: Barcelona
country: Spain
facility: Hospital Sant Pau
Study officials:
References:
Clinical trial NCT05628935: Effect of Anesthesia Method on Neutrophil-Lymphocyte Ratio
Official title: The Effect of Anesthesia Method on Neutrophil-Lymphocyte Ratio in Patients Undergoing Forearm Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammation
Anesthesia
Keywords: General Anesthesia
Neutrophil Lymphocyte Ratio
Peripheral Nerve Block
Lead sponsor: Zonguldak Bulent Ecevit University
Sponsor class: OTHER
First posted: 2022-11-29
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged 18-65 years who have underwent forearm surgery

Brief summary: The neutrophil/lymphocyte ratio (NLR) is a simple and inexpensive marker of the inflammatory response. NLR is affected not only by surgical trauma but also by the anesthetic method. The method of anesthesia can affect NLR, thereby modulating the inflammatory response and surgical outcomes. In this study, it was aimed to evaluate the relationship between blood NLR and anesthesia techniques in patients undergoing forearm surgery, and the secondary aim was to evaluate the relationship between Platelet/lymphocyte ratio (TLR), Mean Platelet Volume (MPV) and anesthesia techniques.


Eligibility criteria: Inclusion Criteria:

* Underwent forearm surgery
* Between aged 18-70
* Under general anesthesia or peripheral nerve block

Exclusion Criteria:

* acute infection
* morbid obesity
* chronic treatment with steroids or immunosuppressants
* recently received chemotherapy
* hepatic and renal dysfunction;
* chronic alcohol abusers
* Multiple trauma
* Patients with missing data in their files

Primary outcomes:
measure: Neutrophil/lymphocyte ratio
timeFrame: up to 24 hours after surgery
Secondary outcomes:
measure: Platelet/lymphocyte ratio
timeFrame: up to 24 hours after surgery
measure: Mean Platelet Volume
timeFrame: up to 24 hours after surgery
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Zonguldak Bülent Ecevit University Medicine Faculty
state: Kozlu
Study officials:
References: