louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02935335: A Study to Measure Relationship Between Antimüllerian Hormone and Initial Dose of Menopur®
Official title: Relationship Between antimüllerian Hormone Measured by a Fully Automated Assay and the Initial Dose of HP-hMG (Menopur®) Prescribed for Infertile Women Undergoing Their First IVF/ICSI Cycle.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2016-10-17
Enrollment: 297
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Specialized fertility centers.

Brief summary: AME is a non-interventional, prospective, longitudinal and multicenter study. This study aims to measure the relationship between antimüllerian hormone serum level (AMH), as measured by a fully automated assay and the initial dose of Menopur® HP-hMG 600 IU/mL prescribed for infertile women undergoing their first IVF/ICSI cycle in the current practice.


Eligibility criteria: Inclusion Criteria:

* Women aged between \[18-42\] years.
* Both ovaries present.
* Regular menstrual cycles presumed to be ovulatory.
* Primary or secondary infertility of any origin for more than 12 months.
* Patient with at least one result of antimüllerian hormone (AMH) measured by a fully automated assay available before inclusion, and performed in the past 12 months before inclusion.
* Candidates eligible to a first IVF/ICSI cycle and for whom Menopur® HP-hMG 600 IU/mL has been prescribed.
* Having received oral and written information on the study, without any objections for the use of his/her anonymized data, and having signed a written Informed Consent Form.

Exclusion Criteria:

* Major uterine or ovarian morphological abnormalities or past ovarian surgery.
* Endometriosis stage III/IV.
* Polycystic ovarian syndrome.
* Major endocrine or metabolic abnormalities without treatment.
* Patient included in an interventional study assessing treatment for infertility.

Primary outcomes:
measure: Spearman correlation coefficient between Menopur® 600 IU/mL dose and AMH serum levels
timeFrame: At baseline (inclusion)
Secondary outcomes:
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hospital FOCH (there may be other sites in this country)
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
Clinical trial NCT02976935: Functional MR Lung Imaging Using Hyperpolarised 129Xe
Official title: FUNCTIONAL MAGNETIC RESONANCE LUNG IMAGING USING INHALED HYPERPOLARISED 129Xe
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
IPF
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2016-11-30
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Volunteers, COPD

Brief summary: The aim of this study is to investigate the potential value of a novel imaging technique (hyperpolarized 129Xe lung imaging) in the diagnosis and assessment of lung disease in patients with COPD and IPF.


Eligibility criteria: General Inclusion criteria

* Male or Female aged over 18 years.
* Capacity to give informed consent
* Normal blood pressure (systolic BP \> 100 mmHg and diastolic BP \> 70 mmHg)
* Resting heart rate \> 50 bpm
* For women, negative urinary β-hCG at the screening and subsequent visits
* Subject able to hold breath for 10 seconds
* Subject able to fit into 129Xe chest coil used for MRI
* Subject able to understand the requirements of the study and to cooperate with the study procedures

Inclusion criteria

HEALTHY VOLUNTEERS

• No significant respiratory disease within the last year

PATIENTS

COPD

* Evidence of airflow obstruction (FEV/FVC \<0.7) and FEV1 \<80% predicted post bronchodilator
* Minimum FVC 1.5L

Exclusion criteria

HEALTHY VOLUNTEERS

* Unsuitable for MRI scanning (e.g. have metal implants or pacemaker or contraindicated following questionnaire)
* Acute respiratory illness within 30 days of MRI
* Subject has received an IMP (not including hyperpolarized 129Xe) within 30 days of MRI and administration of 129Xe deemed inappropriate in context of other study
* Subject deemed unlikely to comply with instructions during imaging
* Do not meet the inclusion criteria above
* Subject not deemed fit enough to tolerate procedure
* Subject deemed unsuitable by clinical investigator for other reasons

PATIENTS

* Unsuitable for MRI scanning (e.g. have metal implants or pacemaker or contraindicated following questionnaire)
* Acute respiratory illness within 30 days of MRI
* Subject has received an IMP (not including hyperpolarized 129Xe) within 30 days of MRI and administration of 129Xe deemed inappropriate in context of other study
* Subject deemed unlikely to comply with instructions during imaging
* Do not meet the inclusion criteria above
* Subject not deemed fit enough to tolerate procedure
* Subject deemed unsuitable by clinical investigator for other reasons

Primary outcomes:
measure: Acquisition of baseline data and images to investigate use of hp129Xe as a diagnostic tool
timeFrame: 4 years
Secondary outcomes:
measure: Collation of data regarding ability of participants to adhere to the study protocol
timeFrame: 4 years
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Hyperpolarised Imaging Lung Facility, QMC, Uni of Nottingham
Study officials:
References:
Clinical trial NCT03772535: Pharmacogenetics for Pain Management in Joint Replacement Patients
Official title: Using Pharmacogenetics to Structure Individual Pain Management Protocols for Joint Replacement Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Arthroplasty Complications
Lead sponsor: Anderson Orthopaedic Research Institute
Sponsor class: OTHER
First posted: 2018-12-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief summary: The purpose of this study is to determine the ability to use pharmacogenetic testing in a joint replacement practice to prescribe the most effective pain medicine for a specific patient.


Eligibility criteria: Inclusion Criteria:

* Primary total hip or total knee arthroplasty cases

Exclusion Criteria:

* History of narcotic dependence

Primary outcomes:
measure: Genetic variants
timeFrame: 10 days postoperative
Secondary outcomes:
measure: pain levels
timeFrame: 10 days postoperatively
Other outcomes:
Locations:
city: Alexandria
country: United States
facility: Anderson Orthopaedic Research Institute
state: Virginia
Study officials:
affiliation: Anderson Orthopaedic Research Institute
name: William Hamilton, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03151135: Energy Turnover in Patients With Anorexia Nervosa
Official title: Does Energy Turnover After Short-term Nutritional Recovery Predict Subsequent Weight Course in Patients With Anorexia Nervosa?
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Anorexia Nervosa
Keywords: Energy metabolism
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: German Research Foundation
name: Hannover Medical School
name: Ruhr University of Bochum
First posted: 2017-05-12
Enrollment: 5
Sex: ALL
Minimum age (years): 13
Maximum age (years): 36
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Anorexia nervosa

Brief summary: Pilot study to assess energy turnover at end of inpatient treatment in 10 patients with Anorexia nervosa.


Eligibility criteria: Inclusion Criteria:

* Anorexia nervosa
* anabolic metabolism
* high compliance
* end of inpatient treatment

Exclusion Criteria:

* any further disease than eating disorder
* smokers

Primary outcomes:
measure: Resting Energy expenditure (REE; kcal/d); Total Daily Energy Expenditure (TDEE; kcal/d)
timeFrame: End of inpatient treatment (T0), within 2 weeks before discharge
Secondary outcomes:
measure: Body weight
timeFrame: T1 = 6 months after first test (T0)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité-Universitätsmedizin
Study officials:
References:
Clinical trial NCT06311435: Utilizing Novel Blood RNA Biomarkers as a Diagnostic Tool in the Identification of Long COVID-19
Official title: Utilizing Novel Blood RNA Biomarkers as a Diagnostic Tool in the Identification of Long COVID-19
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Long COVID
Keywords: COVID-19
Long COVID
Long Haul COVID
Long COVID-19
Long Haul COVID-19
Lead sponsor: MaxWell Clinic, PLC
Sponsor class: INDUSTRY
First posted: 2024-03-15
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be placed into one of fourteen possible cohorts based on their presenting complaints.
Primary purpose: DIAGNOSTIC

Brief summary: The Primary objective of this study is to determine, using unblinded samples, if it is possible to develop an algorithm for the classification of specific blood RNA from patients with long COVID together and separately from the apparent health normal controls and other medical conditions that share the signs and symptoms of long COVID.

Detailed description: Participants will be screened and provide two blood samples28 (+/- 2) days apart. Based on the participants survey results they will be placed into one of fourteen groups that reflect the type of Long COVID the patient is experiencing. Samples will be shipped to the sponsor who will develop an AI process to validate the type of Long COVID and assess its severity. The long term goal is to develop a reliable test to identify the presence of Long COVID and its severity.

Eligibility criteria: Inclusion Criteria:

* Mentally capable of understanding and completing informed consent for the study.
* Precipitants with a lab verified diagnosis of SARS-CoV-2 or clinician note/record that an appropriate rapid test for SARS-CoV-2 was positive.
* To qualify for long COVID group participants will need to have new, persistent symptoms related to SARS-CoV-2 infection. iv. No one under the age of 18.

Exclusion Criteria:

* Subject is unable to provide informed consent.
* Primary Investigator or Sub-Investigator determines the participant's ongoing medical complaints that began after 1 November 2019 are not related to SARS-COV-2 but another disease process.

Primary outcomes:
measure: Develop algorithm to classify RNA sequences to identify long COVID
timeFrame: 30 days
Secondary outcomes:
measure: Develop algorithm to subclassify specific RNA sequences to subclassify types of Long COVID
timeFrame: 30 Days
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Brentwood
country: United States
facility: The MaxWell Clinic
state: Tennessee
city: Brentwood
country: United States
facility: The MaxWell Clinic
state: Tennessee
Study officials:
References:
Clinical trial NCT01598935: Post-exercise Protein Intake for Active Children
Official title: Double Blind Controlled Trial of Protein in Active Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Nestec Ltd.
First posted: 2012-05-15
Enrollment: 36
Sex: ALL
Minimum age (years): 10
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Today, there is an important lack of knowledge on the effects of dietary protein on protein metabolism after physical activity in children. Here, the investigators will measure changes in whole body protein metabolism using minimally invasive techniques and stable isotope methodology at rest and after physical activity with the intake of milk protein.


Eligibility criteria: Inclusion Criteria:

* Healthy and physically active (as determined by medical and activity questionnaire)
* 10-12 years of age
* Within approximately 2 years of estimated age of peak height velocity (PHV)
* Minimum aerobic fitness of 35 ml/kg/min as assessed by the McMaster All-out Progressive Continuous Cycling Protocol
* Having obtained his/her informed assent
* Having obtained his/her legal representative's informed consent

Exclusion Criteria:

* Post-pubertal
* Taking any medication
* Smoker
* Undergoing medical treatment or investigations
* Body mass index \> 24
* Suffer from chronic diseases (with regular intake of drugs, medical history)
* Vegetarians
* Vaccination in the last 4 months
* Any know food allergies or intolerance
* Pregnancy
* Special diet or weight loss program (e.g. Atkins diet)
* Acute illness
* Fever, cold, flu
* Participation in a cholesterol management program with functional foods like food supplement enriched in omega-3 fatty acids, dairy products enriched with phytosterols (margarines, yoghurts).

Primary outcomes:
measure: Whole body protein balance
timeFrame: Participants will be followed for 10 days prior to assessment of whole body protein balance.
Secondary outcomes:
measure: Whole body protein metabolism, metabolites
timeFrame: Participants will be followed for 10 days prior to assessment of whole body protein metabolism and metabolites
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Brian W Timmons, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Volterman KA, Moore DR, Breithaupt P, Godin JP, Karagounis LG, Offord EA, Timmons BW. Postexercise Dietary Protein Ingestion Increases Whole-Body Leucine Balance in a Dose-Dependent Manner in Healthy Children. J Nutr. 2017 May;147(5):807-815. doi: 10.3945/jn.116.239756. Epub 2017 Apr 5.
Clinical trial NCT05883735: Retrospective Study of Radio-induced Toxicities in the Treatment of Lung Cancer With Tomotherapy
Official title: Retrospective Study of Radio-induced Toxicities in the Treatment of Lung Cancer With Tomotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: Tomotherapy
Toxicity
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2023-06-01
Enrollment: 318
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: The cohort will consist of patients with stage II-III non-small cell or small cell lung cancer (ICD-10 code: C34) treated with normo-fractionated radiotherapy of 66 Gy in 33 fractions using Tomotherapy between January 2016 and April 2023 at CHR Metz-Thionville.

Brief summary: Lung cancers treated by Tomotherapy represent between 60 and 100 patients per year at the CHR of Metz-Thionville. Some patients were observed to present acute toxicities during treatment such as dysphagia or esophagitis of CTCAE grade \> 2. Beyond well known therapeutic and comorbidities factors, the pathophysiology of these events is largely ruled by a constitutional factor - the enzymatic equipment allowing more or less good repair of the DNA lesions induced by radiotherapy (RT). This equipment is characteristic of each individual, hence the term individual radiosensitivity (IR).The scientific literature is rather poor in data describing the frequency of these toxicities in patients receiving RT for lung cancer.

The objective of this study is to describe the frequency of acute and late toxicities after normofractionated radiotherapy of 66 Gy in 33 fractions in patients with small cell or non-small cell lung cancer, stage 2 or 3.


Eligibility criteria: Inclusion Criteria:

* stage II-III non-small cell or small cell lung cancer treated with normo-fractionated radiotherapy of 66Gy in 33 fractions using Tomotherapy

Exclusion Criteria:

* patient who refused to be included in the study.

Primary outcomes:
measure: late toxicity of radiotherapy
timeFrame: up to 2 years after tomotherapy treatment
Secondary outcomes:
measure: acute toxicity of radiotherapy
timeFrame: 6 months following tomotherapy treatment
Other outcomes:
Locations:
city: Metz
country: France
facility: CHR Metz-Thionville/Hopital de Mercy
Study officials:
affiliation: CHR Metz Thionville Hopital de Mercy
name: Xavier MICHEL, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03586635: Automated EDSS Score Calculation by Smartphone Application
Official title: Automated EDSS Score Calculation Using a Smartphone Application in Multiple Sclerosis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: MS CHRONIC PROGRESSIVE
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2018-07-13
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - patients coming to the MS Competence and Recovery Centre

Brief summary: The EDSS score is the reference tool for rating disability in patients with multiple sclerosis. It is used in both daily monitoring and clinical research studies.

Its main shortcoming lies in its imprecise and variable nature, with significant inter-examiner variability. This variability is the consequence of the complexity of the score rating and also of its subjective nature.

The application developed aims to reduce the risk of rating error, and to homogenize the results obtained regardless of the examiner and his experience in using the score.


Eligibility criteria: Inclusion Criteria:

* Patients with multiple sclerosis seen at the Central Nervous System Day Hospital as part of their follow-up and requiring neurological examination.
* Age ≥ 18 years
* No opposition to the use of their data

Exclusion Criteria:

- Neurological or general pathology, other than multiple sclerosis, that may interfere with EDSS score scoring

Primary outcomes:
measure: EDSS score apllication VS paper version
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: Nice University Hospital
Study officials:
References:
Clinical trial NCT06628635: Examining Different Modes of Exercise for Acute Reduction in Blood Pressure
Official title: Examining the Effects of Aerobic Exercise, Isometrics, and Stretching on Acute (Post-exercise) Blood Pressure Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: blood pressure
exercise
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compared different modes of exercise for eliciting post-exercise hypotension. The study will randomize 10 healthy participants to 30 minutes of either aerobic exercise, isometric exercise, stretching, or rest (control). Blood pressure and heart rate will be assessed before and for one hour post-exercise.

Detailed description: The purpose is to compare different modes of exercise (aerobic vs. isometric vs. static stretching) for reducing blood pressure post-exercise. : Using a randomized crossover design, 5 male and 5 female (n=10) normotensive university students will participate in four different exercise sessions for 30 minutes: aerobic (cycle ergometer at 70% of VO2max), isometric (alternating wall-sit for 70% of max, and handgrip dynamometer at 30% of max for 2 minutes), stretching (targeting the larger muscle groups of the body), and control (rest). Participants' blood pressure and heart rate will be measured before each exercise session and monitored for 60 minutes afterwards to analyze the post-exercise hypotensive response.

Eligibility criteria: Inclusion Criteria:

* Able to safely perform exercise according to the Get Active Questionnaire

Exclusion Criteria:

* Taking blood pressure medications

Primary outcomes:
measure: Change in systolic blood pressure (mmHg)
timeFrame: Baseline to 60 minutes after exercise
measure: Change in diastolic blood pressure (mmHg)
timeFrame: Baseline to 60 minutes after exercise
Secondary outcomes:
measure: Change in heart rate (beats per minute)
timeFrame: Baseline to 60 minutes after exercise
measure: Change in rate-pressure product (beats per mintues x systolic blood pressure mmHg)
timeFrame: Change from baseline to 60 minutes after exercise
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
Study officials:
References:
Clinical trial NCT00587535: Evaluation of a New MR Pulse Sequence to Quantify Liver Iron Concentration
Official title: Evaluation of a New MR Pulse Sequence to Quantify Liver Iron Concentration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemochromatosis
Keywords: hemochromatosis
liver cirrhosis
liver diseases
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2008-01-07
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Gastroenterology Clinic; Liver Transplant Center; Surgery Clinic

Brief summary: The purpose of this study is to determine if a new MR pulse sequence is accurate in determining how much iron is in the liver.

Detailed description: Quantification of liver iron requires liver biopsy and histological assessment. New rapid MR techniques allow determination of liver relaxation times that can be altered with increasing iron deposition. The purpose of this study is to compare the results obtained with MRI to liver biopsy and iron quantification in patients undergoing liver biopsy in the setting of hemochromatosis.

Eligibility criteria: Inclusion Criteria:

* Undergoing liver biopsy for suspected or known hemochromatosis
* Undergoing liver biopsy for living-related liver donation evaluation

Exclusion Criteria:

* Contraindication to MRI

Primary outcomes:
measure: Accuracy of MR in quantifying liver iron
timeFrame: one time point
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Jeff L Fidler, MD
role: PRINCIPAL_INVESTIGATOR
References: