louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04150432: Correlation Between Exhaled Propofol Concentration With Plasma Concentration in Children
Official title: Propofol in Expiratory Air, a Comparison With Plasma Propofol, BIS Value and Calculated Plasma Concentration During General Anesthesia in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Eye Diseases
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2019-11-04
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Consecutive patients will participate in the study
Primary purpose: BASIC_SCIENCE

Brief summary: Children due for elective eye surgery in propofol based anesthesia will be kept at steady state propofol infusion for maintenance, ventilation via endotracheal tube. Exhaled propofol will be measured continously by Edmon (R) (BBraun) monitor and compared with arterial plasma samples of propofol, drawn 3-5 times during the procedure.

Detailed description: The primary objective of the study is to determine the correlation between simultaneous concentrations of propofol in plasma and expiratory air in children during general anesthesia.

Key secondary objectives include correlating plasma and exhaled measurements of propofol with electroencephalogram (BIS) values and computer estimated propofol concentrations in plasma and brain (TCI: target control infusion) Primary endpoint: Exhaled air and plasma concentration ratios of propofol during general anesthesia in children.

Eligibility criteria: Inclusion Criteria:

* elective eye surgey

Exclusion Criteria:

* known propofol hypersensitivity

Primary outcomes:
measure: Propofol plasma concentration versus simultaneous exhaled concentration
timeFrame: 5 hours
Secondary outcomes:
measure: Propofol exhaled correlation versus Bispectral Index value (BIS)
timeFrame: 5 hours
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Kristin Thagaard, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05875532: Study of Progression to Progressive Fibrosing Interstitial Lung Disease (PF-ILD) Incidence/Management and Treatment
Official title: Incidence Probability of Progression to Progressive Fibrosing Interstitial Lung Diseases and Status of Management and Treatments in Patients With Fibrosing Interstitial Lung Diseases Other Than Idiopathic Pulmonary Fibrosis in Japan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Diseases, Interstitial
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2023-05-25
Enrollment: 34960
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 diagnosed with at least two fibrosing ILD codes (International Statistical Classification of Diseases and Related Health Problems (ICD-10) code or disease code)

Brief summary: The primary objective for this trial is to investigate the incidence probability of progression to Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs) in patients with fibrosing ILD other than Idiopathic Pulmonary Fibrosis (IPF) in real-world setting in Japan.

The secondary objective is to investigate the characteristics of procedures for management and treatment in patients with fibrosing ILD other than IPF in real-world setting in Japan.


Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with at least two fibrosing Interstitial Lung Disease (ILD) codes on different dates in the patient identification period
2. Patients aged 18 years and older on the index date
3. Patients for whom data for the 12 months prior to the index date can be extracted as baseline data

Exclusion Criteria:

1. Patients grouped into the underlying disease of Idiopathic Pulmonary Fibrosis (IPF)
2. Patients who have met PF-ILD progression criteria during the baseline period

Primary outcomes:
measure: Incidence Probability of Progression to Pulmonary Fibrosing-Interstitial Lung Disease (PF-ILDs)
timeFrame: At 6, 12, 18 and 24 months after the index date, defined between 01-Jan-2013 and 6 months before 28-May-2020
Secondary outcomes:
measure: Number of Patients With Treatment of Interest During Follow-up Period
timeFrame: Up to 7.43 years, from 01-Jan-2013 to 28-May-2020
measure: Number of Patients With Management of Interest During Follow-up Period
timeFrame: Up to 7.43 years, from 01-Jan-2013 to 28-May-2020
Other outcomes:
Locations:
city: Ridgefield
country: United States
facility: Boehringer Ingelheim Pharmaceuticals, Inc.
state: Connecticut
Study officials:
References:
Clinical trial NCT05752032: A Long Term Follow-up Study of Subjects Who Received ICM-203 or Matching Placebo
Official title: A Long Term Follow-up Study of Subjects Who Received ICM-203 or Matching Placebo
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Osteoarthritis, Knee
Keywords: Adeno-associated virus
Gene therapy
ICM-203
Osteoarthritis
Lead sponsor: ICM Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2023-03-02
Enrollment: 16
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who received ICM-203 or matching placebo in clinical studies

Brief summary: This is an observational study of the long term safety and efficacy of ICM-203.

Detailed description: Subjects who have received ICM-203 or matching placebo from ICM-203 clinical studies will be enrolled. Subjects will be contacted annually to collect safety and efficacy outcomes until 5 years after the last dose of ICM-203 or placebo.

Eligibility criteria: Inclusion Criteria:

* Previous receipt of ICM-203 or matching placebo

Exclusion Criteria:

* None

Primary outcomes:
measure: Incidence of delayed adverse events
timeFrame: Up to 5 years
Secondary outcomes:
measure: Knee pain
timeFrame: Up to 3 years
measure: Knee function
timeFrame: Up to 3 years
measure: Magnetic Resonance Imaging Osteoarthritis Knee Score (MOAKS)
timeFrame: Up to 3 years
measure: Joint space width
timeFrame: Up to 3 years
measure: Incidence of total knee replacement
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Geelong
country: Australia
facility: Barwon Health
state: Victoria
Study officials:
affiliation: ICM Co. Ltd.
name: Alison Heald, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01118832: Using High Resolution Function Imaging To Detect Melanoma and Dysplastic Nevi
Official title: Using High Resolution Function Imaging To Detect Melanoma and Dysplastic Nevi
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Keywords: Thermography
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
name: National Cancer Institute (NCI)
First posted: 2010-05-07
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subject population will be identified in the Department of Dermatology Pigmented Lesion Clinic at the Johns Hopkins Hospital Outpatient Center. Recruited patients will only comprise those requesting a cutaneous pigmented lesion removed or patients that are examined and found to have a pigmented lesion that is suspicious for malignancy at the time of their visit, and thus recommended to have a skin biopsy for diagnosis following the standard of care

Brief summary: A novel infrared imaging tool to aid in the clinical detection of atypical pigmented lesions and melanoma is developed. Goals include evaluation of the utility of high-resolution infrared scanning of cutaneous lesions in the diagnosis of pigmented lesions and the identification of high-risk lesions and melanomas.

Detailed description: This study uses a specific skin protocol to cool the skin and then measures the cutaneous thermal recovery to uniquely identify lesions that may be cancerous. Using computer models, the thermal signature is used to determine the size and shape of the lesions in question. In particular, this study seeks to add quantification analysis of high resolution thermal images of melanoma lesions to provide accurate early diagnostic capability with specific detail regarding size, shape and depth of the lesions. This information will be compared to biopsy results and surgical resection results.

Eligibility criteria: Inclusion Criteria:

* Patients seen in the high-risk pigmented lesion clinic, who posses a pigmented lesion with a clinical indication for biopsy

Exclusion Criteria:

* None

Primary outcomes:
measure: Ability to Detect of the melanoma lesions
timeFrame: up to 2 years
Secondary outcomes:
measure: Measurement of thermal signatures of benign cutaneous lesions
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Cila Herman, Dr-Ing.
role: PRINCIPAL_INVESTIGATOR
References:
citation: C HERMAN, THREE-DIMENSIONAL THERMAL IMAGING FOR THE DETECTION OF SKIN LESIONS AND OTHER NATURAL AND ABNORMAL CONDITIONS - WO Patent WO/2012/009,359, 2012
citation: Herman C. Emerging technologies for the detection of melanoma: achieving better outcomes. Clin Cosmet Investig Dermatol. 2012;5:195-212. doi: 10.2147/CCID.S27902. Epub 2012 Nov 12.
Clinical trial NCT01186432: Preliminary Safety and Efficacy of the PDS-1.0 in Patients With Neovascular Age Related Macular Degeneration (AMD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Age-Related Macular Degeneration
Lead sponsor: Forsight Vision4
Sponsor class: INDUSTRY
First posted: 2010-08-23
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the preliminary safety and efficacy of PDS 1.0 in patients with neovascular AMD.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of CNV secondary to AMD confirmed by fluorescein angiography, not previously treated
* Retinal thickness due to edema of at least 300um in the study eye
* Best corrected visual acuity of 20/40 or worse in the study eye
* Best corrected visual acuity of 20/40 or better in the fellow eye

Exclusion Criteria:

* Evidence of scarring CNV (e.g. geographic atrophy) in the study eye
* Fibrosis \>75% of lesion area in the study eye

Primary outcomes:
measure: Change in retinal thickness measured by Optical Coherence Tomography
timeFrame: Monthly
Secondary outcomes:
measure: Change in Best Corrected Visual Acuity
timeFrame: Monthly
Other outcomes:
Locations:
city: Riga
country: Latvia
Study officials:
References:
Clinical trial NCT02422732: Functional Imaging and Reading Deficit in Children With NF1
Official title: Functional Magnetic Resonance Imaging and Reading Deficit in Children With NF1 Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurofibromatosis Type 1
Keywords: NF1
Children
Reading disability
Morphological and functional MRI
Genetic analysis
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2015-04-21
Enrollment: 25
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: A monocenter pilot study on the acceptability and feasibility of a functional MRI protocol in children with NF1 with or without reading disabilities.

Detailed description: The principal aim of the study is to highlight the activation of brain area involved phonological and visuo-spatial processing in children with NF1 with or without reading disabilities.

Eligibility criteria: Inclusion Criteria:

* Age included between 8 and 12 years
* Child presenting a type 1 neurofibromatosis according to 2 criteria in the following criteria list :

  * At least 6 café au lait spots
  * 2 or more neurofibromas or 1 plexiform neurofibroma
  * axillary or inguinal freckling
  * 1 optic nerf glioma
  * 2 or more Lisch nodules
  * 1 osseous lesion as sphenoid dysplasia or thinning of the long bone cortex with or without pseudarthrosis
  * 1 A first degree relative (parent, sibling, or offspring) with NF1 by the above criteria
* Membership in a national insurance
* Consent of the child and the parents

Exclusion Criteria:

* Mental retardation (QI T \< 70)
* Treated or untreated epilepsy
* Visual deficit (visual Acuteness \< 4/10
* Presence of a symptomatic optic glioma
* Presence of a brain tumor.

Primary outcomes:
measure: Percentage of children performing in full the protocol functional MRI
timeFrame: day 1
Secondary outcomes:
measure: blood flow in milliliters per minute
timeFrame: day 1
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU Toulouse
Study officials:
affiliation: CHU Toulouse
name: Yves Chaix, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06426732: The Trajectory of Blood Pressure During Pregnancy in Assisted Reproductive Females
Official title: The Trajectory of Blood Pressure During Pregnancy in Assisted Reproductive Females
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Blood Pressure
Lead sponsor: The Second Hospital of Shandong University
Sponsor class: OTHER
First posted: 2024-05-23
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: collect sixty patients in each group

Brief summary: The incidence of gestational hypertension and preeclampsia in the assisted reproductive technology population during pregnancy was significantly higher than that in the general normal pregnancy population. The use of assisted reproductive technology in this population due to infertility is often accompanied by many hypertension-related factors. We established a prospective cohort study based on assisted reproductive technology pregnancy population and natural pregnancy population. Through continuous monitoring of blood pressure changes and other risk factors during pregnancy in the two groups, we explored the trajectory trend and inflection point of assisted reproductive technology pregnancy population blood pressure during pregnancy. Through factor analysis, the risk factors of elevated blood pressure during pregnancy can be clearly identified, so as to carry out early intervention and strengthen the control of risk factors of elevated blood pressure in assisted reproductive technology population, in order to expect benign maternal and infant outcomes.


Eligibility criteria: Inclusion Criteria:

-Exposure group:

Mother: Seen in the obstetrics department of our hospital and meet the following conditions at the same time:

1. Complete at least one cycle of IVF or ICSI, PGD or IVM treatment (including natural cycles);
2. Clinical pregnancy was obtained after treatment. Offspring: Offspring born after in vitro fertilization-embryo transfer technique.

   * Non-exposed group:

Mother: A mother who conceived naturally. Offspring: 1) Offspring born by natural pregnancy. 2) Offspring born from natural pregnancy of exposed mothers.

Exclusion Criteria:

* Unwilling to participate in this research;
* Unable to participate in this study due to special reasons, such as death, immigration, loss to follow-up;
* Hereditary diseases, mental diseases, malignant tumors, pre-pregnancy hypertension, uterine malformations and other reproductive organ malformations;
* Pregnant women who voluntarily terminate pregnancy due to non-preeclampsia factors;

Primary outcomes:
measure: The Trajectory of Blood Pressure During Pregnancy in Assisted Reproductive Females
timeFrame: from pregnancy to delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Cui linlin
Study officials:
References:
Clinical trial NCT06396832: Comparing Post-Surgical Symptoms: Gastric Sleeve With and Without Omentopexy "Comparing Post-Surgical Symptoms: Gastric Sleeve With and Without Omentopexy" Comparison of Postoperative Symptoms: Gastric Sleeve With and Without Omentopexy.
Official title: POST-SURGICAL SYMPTOMS IN PATIENTS UNDERGOING GASTRIC SLEEVE SURGERY: OMENTOPEXY VS. NO OMENTOPEXY
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Procedure, Unspecified
Keywords: Omentopexy
Complications
Metabolic surgery
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
First posted: 2024-05-02
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with obesity who underwent sleeve gastrectomy, with or without omentopexy

Brief summary: Metabolic surgery has proven to be an effective treatment for obesity, with laparoscopic sleeve gastrectomy being the most popular procedure. Omentopexy (OP) is proposed as a strategy to reduce associated complications. Objective was to determine the effectiveness of omentopexy in controlling post-surgical symptoms and to measure the need for re-intervention, leakage, bleeding, and mortality in patients undergoing laparoscopic sleeve gastrectomy.

Detailed description: Patients who underwent laparoscopic sleeve gastrectomy (LSG). Of these patients, 53 received LSG with omentopexy (OP) and 52 underwent LSG without omentopexy (NO OP) between 2022 and 2023. Each group was attended by a different surgeon. The analysis focused on data concerning gastrointestinal symptoms recorded 24 hours postoperatively, as well as documented cases of bleeding, leakage, re-operation, and mortality during the hospitalization period

Eligibility criteria: Inclusion Criteria:

* Diagnosis of obesity
* Adults over 18 years old
* Undergoing sleeve gastrectomy
* Consent to respond to the immediate postoperative symptom questionnaire

Exclusion Criteria:

* Repair of hiatal hernia
* Refusal to complete the evaluation instrument
* Unavailability of medical records

Primary outcomes:
measure: Postoperative gastrointestinal symptoms
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Unidad de Investigación Biomédica 02, Unidad Médica de alta especialidad, Hospital de Especialidades Centro Médico Nacional de Occidente, Instituto Mexicano del Seguro Social, Guadalajara 44329, Mexico
state: Jalisco
Study officials:
References:
Clinical trial NCT01002937: Novel Prognostic Markers in Renal Cancer
Official title: Novel Prognostic Markers in Renal Cancer: a Protocol for the Analysis of Paraffin Embedded Tumour Samples
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Cell Carcinoma
Keywords: Biomarkers
Prognosis response to treatment
Renal cancer
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2009-10-28
Enrollment: 182
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: Tumour tissue from subjects with renal cell carcinoma, who have been treated at the Royal Marsden Hospital

Brief summary: The purpose of this project is to analyze tumour tissue from a group of subjects with renal cell carcinoma, who have been treated at the Royal Marsden Hospital.

Detailed description: Renal cancers have different clinical outcomes. The principal research objective is to study tumour tissue from renal cancer patients and try and understand why some cancers progress more rapidly than others. Further, another key aim of this study is to try and understand why some patients respond to treatment and others do not.

Eligibility criteria: Inclusion Criteria:

* The presence of histologically proven renal cell cancer
* The availability of paraffin embedded tissue
* Informed consent needed for tissue taken after January 2006 (date of enforcement of human tissue act)

Exclusion Criteria:

* Absence of histological tissue
* Absence of consent to study tissue after January 2006

Primary outcomes:
measure: The profiling of the expression of signal transduction biomarkers, gene expression, gene copy numbers and effect of mutations of the VHL gene in renal cancer and their relationship to clinical outcomes.
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
state: Surrey
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: Professor Martin Gore
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02349737: Evaluation of Interference Between Bioelectrical Impedance Analysis and Implantable Cardioverter Defibrillators
Official title: Use of Bioelectrical Impedance Analysis in the Nutritional Assessment of Patients With CHF Equipped With Implantable Cardioverter Defibrillators
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Electromagnetic Interference
Keywords: Bioelectrical Impedance Analysis
Body composition
ICD
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2015-01-29
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ICD.

Brief summary: Evaluation of electromagnetic interference between Bioelectrical Impedance Analysis (BIA) and implantable cardioverter defibrillators (ICDs).

Detailed description: Electrograms of ICDs will be analyzed during wireless telemetry and during body composition measurement using BIA. ICD therapy will have been temporarily inactivated before the measurement to avoid inappropriate shocks, and the sensitivity level of the ICD will be set to maximum. Body composition will be measured at three frequencies (5 khz, 50 khz and 100 khz).

Interference will be assessed by the presence of visible artefacts on the real-time electrogram, with ICD marker annotations showing atrial and/or ventricular sensed episodes. The outcome measure will be the number and proportion of patients who have electromagnetic interferences of the ICD when BIA is done.

The procedure will take approximately 5-10minutes, with reprogramming of the device at the end of the test. No further follow-up in the context of the study will be performed.

Eligibility criteria: Inclusion Criteria:

* Implantation with a wireless-enabled ICD

Exclusion Criteria:

* Age \<18yrs
* Inability to sign an informed consent
* Pacemaker dependancy

Primary outcomes:
measure: Number of patients who have electromagnetic interference of the ICD when exposed to BIA.
timeFrame: 5-10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Geneva 14
country: Switzerland
facility: University Hospital Geneva
Study officials:
References:
citation: Buch E, Bradfield J, Larson T, Horwich T. Effect of bioimpedance body composition analysis on function of implanted cardiac devices. Pacing Clin Electrophysiol. 2012 Jun;35(6):681-4. doi: 10.1111/j.1540-8159.2012.03377.x. Epub 2012 Mar 27.
citation: Meyer P, Makhlouf AM, Mondouagne Engkolo LP, Trentaz F, Thibault R, Pichard C, Burri H. Safety of Bioelectrical Impedance Analysis in Patients Equipped With Implantable Cardioverter Defibrillators. JPEN J Parenter Enteral Nutr. 2017 Aug;41(6):981-985. doi: 10.1177/0148607116633823. Epub 2016 Feb 22.