louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04525807: Precision Medicine for Colorectal Cancer Liver Metastasis Guided by Multi-omics Data Under the Umbrella Theory
Official title: Precision Medicine for Colorectal Cancer Liver Metastasis Guided by Multi-omics Data Under the Umbrella Theory
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer Metastatic
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2020-08-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were newly diagnosed with liver metastases from colorectal cancer (pathologically diagnosed as adenocarcinoma)

Brief summary: In order to more accurately discover the cause of drug resistance in tumor treatment, and to provide a new basis for precise treatment.

Therefore, based on the umbrella theory of precision medicine, we carried out this single-center, prospective, and observational study to include patients with liver metastases from colorectal cancer. By combining genome, transcriptome, and proteomic sequencing data, we established a basis for colorectal cancer liver Transfer the multi-omics data of the sample, describe the reason for the resistance of the first-line treatment, and search for new therapeutic targets.


Eligibility criteria: Inclusion Criteria:

* ECOG score 0-2 points
* Pathologically diagnosed patients with colorectal cancer
* Combined with liver metastases confirmed by imaging, and the lesion is measurable (RECIST standard)
* The lesion is available
* First-line treatment failed; hematology, liver and kidney function tests are suitable for back-line treatment
* Informed consent

Exclusion Criteria:

* With brain metastases
* History of other malignancies
* Pregnancy or breastfeeding
* Have received other drug clinical studies within 30 days before the start of this study

Primary outcomes:
measure: Objective response rate
timeFrame: 1 year
Secondary outcomes:
measure: progression-free survival
timeFrame: 1 year
measure: Overall survival
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03827707: Effect of Ambient Noise on the Responses to Meal Ingestion
Official title: Factors That Determine the Responses to Meal Ingestion: Effect of Ambient Noise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: meal ingestion
postprandial responses
hedonic sensations
homeostatic sensations
ambient noise
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2019-02-01
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Meal ingestion induces sensations that are influenced by a series of conditioning factors. Aim: to determine the effect of ambient noise on the sensory responses to a standard probe meal. Randomized, cross-over study in healthy subjects comparing the effect of ambient noise versus silence on the sensations induced by a probe meal. Participants (12 men) will be instructed to eat a standard dinner the day before, to consume a standard breakfast at home after overnight fast, and to report to the laboratory, where the test meal will be administered 5 h after breakfast. Studies will be conducted in a quiet, isolated room with participants sitting on a chair. One study day, a noise will applied via headphones for 60 min after meal ingestion and the other day headphones without sound will applied. Perception of homeostatic sensations (hunger/ satiation, fullness) and hedonic sensations (digestive well-being, mood) will be measured at 5 min intervals 10 min before and 20 min after ingestion and at 10 min intervals up to 60 min after the probe meal.


Eligibility criteria: Inclusion Criteria:

* non-obese

Exclusion Criteria:

* history of gastrointestinal symptoms
* prior obesity
* use of medications
* history of anosmia and ageusia
* current dieting
* alcohol abuse
* psychological disorders
* eating disorders

Primary outcomes:
measure: Change in digestive well-being induced by the probe meal
timeFrame: 1 day
Secondary outcomes:
measure: Change in fullness sensation induced by the probe meal
timeFrame: 1 day
measure: Change in mood induced by the probe meal
timeFrame: 1 day
measure: Change in hunger/satiety induced by the probe meal
timeFrame: 1 day
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: University Hospital Vall d'Hebron
Study officials:
References:
citation: Pribic T, Azpiroz F. Biogastronomy: Factors that determine the biological response to meal ingestion. Neurogastroenterol Motil. 2018 Jul;30(7):e13309. doi: 10.1111/nmo.13309. Epub 2018 Feb 2.
Clinical trial NCT01759407: Femoral Nerve Block for Femur Fracture Repair in Pediatrics
Official title: A Prospective, Double-blinded, Randomized Comparison of Ultrasound-guided Femoral Nerve Block With Lateral Femoral Cutaneous Nerve Block Versus Standard Anesthetic Management for Traumatic Femur Fracture Repair in the Pediatric Population
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Traumatic Femur Fracture
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2013-01-03
Enrollment: 19
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to prospectively compare post-operative pain relief in pediatric patients undergoing traumatic femur fracture repair who have received either a femoral nerve block with a lateral femoral cutaneous nerve block or a standard anesthetic for analgesia.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I or II
* Weight greater than or equal to 10kg
* Presenting for repair of traumatic femur fracture

Exclusion Criteria:

* ASA physical status \> II
* Co-morbid diseases (cardiac, pulmonary, neurological disease)
* Patients having concomitant procedures
* Abnormal neurovascular examination in the injured leg
* Presence of vascular compromise in the affected lower extremity
* Mechanism of sustained injury via crush injury
* Use of therapeutic dose anticoagulants or presence of a bleeding disorder

Primary outcomes:
measure: Post-anesthesia Care Unit (PACU) Pain Scores
timeFrame: 30 mins after surgery
Secondary outcomes:
measure: Intraoperative End-tidal Isoflurane %
timeFrame: 1 1/2 hr.
measure: Time to First Opioid Dose
timeFrame: From PACU discharge until first opioid dose on the ward, assessed up to 24 hours
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's
state: Ohio
Study officials:
affiliation: Nationwide Children's
name: Nicole Elsey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04690907: Intervention, Dietary, Diabetes, Pregnancy
Official title: Dietary Intervention for Obese Pregnant Women - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Habits
Obesity
Gestational Diabetes
Gestational Weight Gain
Lead sponsor: University of Eastern Finland
Sponsor class: OTHER
First posted: 2020-12-31
Enrollment: 33
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention group and control group.
Primary purpose: PREVENTION

Brief summary: The aim of this rct -study is to explore the effect of a dietary intervention for overweight (body maas index BMI≥25) and obese (BMI≥30) pregnant women on gestational weight gain and the prevalence of gestational diabetes.

Detailed description: Pregnant women are recruited for the study from 18 maternity care clinics in Northern Savo and Northern Karelia area. The participants will be randomized into intervention and control groups. All the participants will have access to the study web-pages, which includes written material of healthy diet during pregnancy as well as all the study material (4 day food records, Three factor eating questionnaire (TFEQ R-18) and Binge Eating Scale (BES)). In addition, intervention group will get two virtual dietary counseling sessions by a dietician. The information on participants' gestational weight gain and the result of oral glucose tolerance tests will be collected by the public health nurses after birth.

Eligibility criteria: Inclusion Criteria:

* BMI 25 or higher
* healthy, no chronic medical conditions that can prevent participating to the study
* singleton pregnancy
* first trimester of pregnancy at the time of recruitment

Exclusion Criteria:

* BMI less than 25
* chronic medical conditions
* multiple pregnancy
* pregnancy at second or third trimester at the time of recruitment

Primary outcomes:
measure: Gestational weight gain (GWG)
timeFrame: immediately after the intervention
Secondary outcomes:
measure: Gestational diabetes mellitus (GDM)
timeFrame: immediately after the intervention
measure: Eating habits I
timeFrame: During the intervention up to gestational weeks 36-37
measure: Eating habits II
timeFrame: During the intervention up to gestational weeks 37-42
measure: Eating habits III
timeFrame: During the intervention up to gestational weeks 37-42
Other outcomes:
Locations:
city: Joensuu
country: Finland
facility: Antenatal maternity care clinics (n=6)
city: Kuopio
country: Finland
facility: Antenatal maternity care clinics (n=12)
Study officials:
affiliation: University of Eastern Finland
name: Reeta Lamminpää
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02110407: Modulation of Visual-Spatial Learning in Healthy Young Adults by tDCS
Official title: Modulation of Visual-Spatial Learning in Healthy Young Adults by Transcranial Direct Current Stimulation - Proof of Principle and Mechanisms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Young Adults
Keywords: healthy young adults
tDCS
LOCATO task
visual-spatial learning
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2014-04-10
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate whether a combination of intensive training of visual-spatial abilities (LOCATO task) with anodal transcranial direct current stimulation (tDCS) leads to an improvement of learning and memory in healthy young adults and to examine the underlying neuronal mechanism.


Eligibility criteria: Inclusion Criteria:

* right handednesss
* unobtrusive neuropsychological screening
* age: 18-35 years

Exclusion Criteria:

* severe internal or psychiatric disease
* epilepsy
* other severe neurological disease, e.g. previous major stroke, brain tumor
* DMS-IV manifest dementia
* contraindication for MRT (claustrophobia, metallic implants, tattoos)

Primary outcomes:
measure: performance in LOCATO task (visual-spatial learning and memory) after a combination of intensive visual-spatial training and tDCS
timeFrame: immediately after end of a 3 day period of training in tDCS condition vs sham condition
Secondary outcomes:
measure: long term effects
timeFrame: after 1 month vs baseline
measure: functional changes: Connectivity
timeFrame: after end of 3-day cognitive training vs baseline
measure: cortical excitability
timeFrame: at baseline
measure: Quality of Life
timeFrame: after 1 month vs baseline
measure: memory
timeFrame: immediately after end of 3-day of cognitive training, after 1 month vs. baseline
measure: genotyping of learning related polymorphisms
timeFrame: once
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Agnes Flöel, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05222607: Longitudinal Evaluation and Real-world Evidence of NT201
Official title: LONG RUN: LONGitudinal Evaluation and Real-world Evidence of Uniquely Purified incobotulinumtoxinA (Xeomin) in Treatment Naïve Participants
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Glabellar Frown Lines and Canthal Lines and/or Horizontal Forehead Lines in the Upper Face
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2022-02-03
Enrollment: 11
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: Male and female participants, 18 years of age or older, seeking treatment with incobotulinumtoxinA for UFL in the North American, Latin American, European, and Asia-Pacific regions.

Brief summary: This study is to collect long-term real-world evidence data from clinics in several countries in order to obtain an improved understanding of the safety and effectiveness of incobotulinumtoxinA in botulinum neurotoxin type A (BoNT-A) treatment naïve participants.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older.
* Planning treatment with incobotulinumtoxinA.

Exclusion Criteria:

* Any contraindication to treatment with incobotulinumtoxinA or any other neurotoxins.
* Currently pregnant, breastfeeding, or intending to become pregnant during study participation.
* Known hypersensitivity to incobotulinumtoxinA or any of its formulation ingredients.
* Any infection and/or inflammation at the planned injection points.
* Previous treatment with any botulinum toxin products for any aesthetic or therapeutic indications.

Primary outcomes:
measure: Assessment of FACE-Q Patient-Perceived Age Visual Analogue Scale mean change
timeFrame: Up to 3 years
Secondary outcomes:
measure: Assessment of FACE-Q Satisfaction with Decision Scale mean change
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Arlington
country: United States
facility: SkinDC
state: Virginia
Study officials:
References:
Clinical trial NCT06113107: Impact of Modifications to the Rendering of the Antibiogram on the Prescriptions of Meropenem in Pseudomonas Bacteremia
Official title: Impact of Modifications to the Rendering of the Antibiogram on the Prescriptions of Meropenem in Pseudomonas Bacteremia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pseudomonas
Keywords: Pseudomonas
Meropenem
Microbial susceptibility testing
EUCAST breakpoint
Antibiotic stewardship
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major subject (≥18 years old) with a positive blood culture result for Pseudomonas spp identified in the microbiology laboratory of Strasbourg University Hospital during the period from June 1, 2018 to November 30, 2022

Brief summary: Modification of the rendering of the antibiogram at the Strasbourg University Hospital in November 2019 with the appearance of the concept of "standard dose" or "high dose" sensitivity.

This modification seems to have favored an inappropriate overprescription of Meropenem (the only antibiotic made "at standard dose") in Pseudomonas infections sensitive to other beta-lactams.

In June 2021, it was therefore decided to mask sensitivity to carbapenems by default in the rendering of Pseudomonas antibiograms when the strain was sensitive to a narrower spectrum beta-lactam ("restricted" antibiogram).

The aim of this study is to evaluate the impact of these changes in the antibiogram on antibiotic prescriptions.


Eligibility criteria: Inclusion Criteria:

* Major subject (≥18 years old)
* Subject with a positive blood culture result for Pseudomonas spp identified in the microbiology laboratory of Strasbourg University Hospital during the period from June 1, 2018 to November 30, 2022
* Subject not opposing the reuse of their data for the purposes of this research.

Exclusion Criteria:

* Subject having expressed opposition to participating in the study,
* Pseudomonas spp strain resistant to all first-line beta-lactams (Piperacillin-Tazobactam, Ceftazidime, Céfepime and Aztreonam).
* Pseudomonas spp strain resistant to Meropenem.
* Lack of information on the antibiotic treatment undertaken.

Primary outcomes:
measure: Proportion of Meropenem prescriptions in Pseudomonas spp bacteraemia susceptible to narrow-spectrum betalactams
timeFrame: Files analysed retrospectively from June 1, 2018 to November 30, 2022 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service des Maladies Infectieuses et Tropicales - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT05285007: Limited Ankle Dorsiflexion and Effect on Single Limb Squats in Individuals With Patellofemoral Pain
Official title: Limited Ankle Dorsiflexion and Effect on Single Limb Squats in Individuals With Patellofemoral Pain: Interventions and Outcomes in a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Patellofemoral Pain
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2022-03-17
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this graduate student research study is to investigate the relationship between limited ankle dorsiflexion and the potential effects on a single limb squat task in the Patellofemoral/Knee Pain population.

Detailed description: 1. Participants will undergo Covid screening prior to filling out consent form and PHI. Randomization will occur to create an experimental group and a minimal intervention group.
2. Participants will complete two self-reported questionnaires on how their diagnosis affects functional activities.
3. Dorsiflexion range of motion in a weight bearing position will be taken.
4. Hip abductor strength on tested limb will be measure on isokinetic device.
5. The Lateral Step Down test will be conducted for 6 trials on each participant, 3 with a heel wedge and 3 without, movement recorded, and graded using two motion capture devices.
6. The experimental group will receive two interventions to increase dorsiflexion range of motion. The minimal intervention group will read and infographic and complete 5 minutes of treadmill walking.
7. Each participant will then have their dorsiflexion measured again prior to completing another 3 trials of the Lateral Step Down test.

Eligibility criteria: Inclusion Criteria:

* History of active Patellofemoral Pain for at least 6 months
* No clinic based therapeutic interventions for a 6-month period prior to testing
* Females aged 18-59 years' old
* Limited ankle dorsiflexion as noted by \<45degs using the weight bearing lunge test

Exclusion Criteria:

* History of musculoskeletal surgery or fractures on the tested leg or lumbar spine that could affect their biomechanics during the study
* History of soft tissue or skeletal abnormalities in the tested limb
* Current knee effusion
* Resting pain greater than 5/10

Primary outcomes:
measure: Weight bearing lunge test
timeFrame: change between baseline and post intervention on Day 1
Secondary outcomes:
measure: Patellofemoral Disability Index
timeFrame: change between baseline and post intervention on Day 1
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
Study officials:
affiliation: Loma Linda University
name: Everett Lohman, Dsc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00952107: Objective Flap Assessment During Reconstructive Surgery
Official title: Objective Flap Assessment During Reconstructive Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Cancer
Keywords: breast cancer
breast reconstructive surgery
flap assessment
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2009-08-04
Enrollment: 6
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The main purpose of this study is to test the ergonomics of an investigational imaging system that can take pictures of blood vessels under the skin. In plastic and reconstructive surgery, blood flow to tissue determines whether the tissue can be transplanted from one location to another. This new imaging device uses invisible near-infrared fluorescent light to see blood vessels that otherwise could not be seen by eye. This study will test the system's basic operation and ergonomics in the operating room.

Detailed description: To perform a pilot study of the FLARE™ NIR fluorescence imaging system in conjunction with indocyanine green (ICG) during breast reconstructive surgery utilizing deep inferior epigastric perforator (DIEP) flaps.

Due to patient-to-patient anatomic variation, the vascular perfusion to the cutaneous elements in flaps is unpredictable and of great concern to the surgeon planning the design of the flap. We propose a method of imaging the flap based on the use of invisible near-infrared fluorescent light that has significant advantages for both patient and surgeon.

Specific Aims:

A pilot optimization study of the imaging system in combination with ICG to determine optimal dose, light excitation fluence rate, and camera exposure time.

Eligibility criteria: Inclusion Criteria:

* Women or men above the age of 21 who are undergoing unilateral breast reconstruction after mastectomy.
* Women of childbearing age must have a negative pregnancy test as confirmed by anesthesiologist.

Exclusion Criteria:

* Patients with a known or suspected iodide or seafood allergy.
* Patients with known renal, cardiac, hepatic, or pulmonary disease.
* BMI \> 30

Primary outcomes:
measure: System operation
timeFrame: 2 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: John V Frangioni, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee BT, Hutteman M, Gioux S, Stockdale A, Lin SJ, Ngo LH, Frangioni JV. The FLARE intraoperative near-infrared fluorescence imaging system: a first-in-human clinical trial in perforator flap breast reconstruction. Plast Reconstr Surg. 2010 Nov;126(5):1472-1481. doi: 10.1097/PRS.0b013e3181f059c7.