louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04025606: Paravertebral Block Versus Thoracic Epidural Analgesia
Official title: Paravertebral Block Versus Thoracic Epidural Analgesia in Patients Undergoing Video Assisted Lung Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Postoperative Pain
Keywords: Epidural analgesia
Pneumonectomy
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
First posted: 2019-07-19
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Thoracic epidural analgesia (TEA) is the basic method of analgesia in patients undergoing pulmonary lobectomy. TEA is considered to be a safe and thoroughly investigated method of pain relief that rarely causes serious complications. However, blocking the nerves as they emerge from the spinal column (paravertebral block, PVB) may represent an alternative method with some potential benefits. In this study, TEA and PVB will be compared for patients undergoing pulmonary lobectomy by video assisted thoracoscopic surgery. The aim of the study is to test the hypothesis, that PVB is a time-saving procedure compared with TEA on the day of surgery and that PVB is as efficient in postoperative pain reduction as TEA.


Eligibility criteria: Inclusion Criteria:

Patients with lung cancer in stage 1 or 2 who are accepted for VATS-lobectomy

Exclusion Criteria, preoperative:

Patients who do not wish to participate

Patients with:

* suspicion of ingrowth in the thoracic wall.
* marginal lung function.
* kidney failure.
* chronic pains and/ or daily use of opioids.
* cognitive, visual and / or linguistic dysfunction.
* allergies to drugs used in the paravertebral block or the thoracic epidural analgesia.

Exclusion Criteria, Per- and postoperative

* conversion from VATS to thoractomy.
* unsuccessful admission of thoracic epidural analgesia
* unsuccessful admission of paravertebral block
* postoperative respiratory treatment
* postoperative delirium Patients who for various reasons are not able to self-report pain after surgery.

Patients who wish to withdraw from the study

Primary outcomes:
measure: Time in minutes total time at the operating ward
timeFrame: 1 hour
measure: Pain intensity during hospitalization: Numerical Rating Scale (NRS)
timeFrame: Up to 12 months after surgery
Secondary outcomes:
measure: Hospital length of stay in days
timeFrame: until discharge from hospital (max 1 month)
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: St. Olavs Hospital
name: Alexander Wahba, md phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT03076606: Nurses Ability to Assess Visual Acuity in Geriatric Consultation
Official title: Nurses Ability to Assess Visual Acuity in Geriatric Consultation
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Visual Acuity
Accidental Fall
Aging
Nurse's Role
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2017-03-10
Enrollment: 15
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 65 and over referred for Visual Acuity evaluation

Brief summary: Nurses participate to geriatric evaluations for falling patients. For these patients, it is recommended to evaluate,especially, visual acuity but this is not currently done because it is difficult to systematically combine with an ophthalmologic consultation.

The HAS french recommendations propose to detect visual acuity deficiency using Monoyer and Parinaud scales, without specifying the professional qualification. According to the nurse competence decree of State Graduates, "sensory disorders" screening is a "non-vulnerable" examination, and can be performed by nurses. Therefore, they can use these scales, after training.

We propose to evaluate the correlation between visual acuity scores obtained by nurses in geriatric consultations and an ophthalmologist.

This study should include 204 patients over 65 years, who have fallen at least twice in the last 12 months. These patients will benefit from an evaluation by an ophthalmologist, after the geriatric consultation.


Eligibility criteria: Inclusion Criteria:

* at least 2 falls in the last 12 months,
* applied in geriatric evaluation
* talking French
* affiliated to the social security system

Exclusion Criteria:

* not communicating
* illiterate
* Total blindness

Primary outcomes:
measure: visual acuity values concordance between nurses and ophthalmologist
timeFrame: day 1
Secondary outcomes:
measure: new diagnosis or ophthalmologic pathology aggravation
timeFrame: day 1
measure: cognitive influence
timeFrame: day 1
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
Study officials:
References:
Clinical trial NCT00294606: Comparison of the Effects of Phenylephrine and Norepinephrine on Cardiac Function During Carotid Artery Surgery
Official title: Comparison of the Effects of Phenylephrine and Norepinephrine on Cardiac Function During Carotid Cross-Clamping During Carotid Endarterectomy Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vasopressor Agents
Endarterectomy, Carotid
Echocardiography, Transesophageal
Keywords: vasopressor agents
carotid endarterectomy
cardiac function
transesophageal echocardiography
wall motion abnormalities
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2006-02-22
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This will be a prospective, randomized, double-blinded, cross-over clinical trial to compare the effects of phenylephrine or norepinephrine on cardiac function during carotid artery surgery in patients under general anesthesia. The effect of the vasopressor on cardiac function will be measured using electrocardiography, transesophageal echocardiography and cardiac troponin I intraoperatively and postoperatively. We will use a cross-over pattern since both drugs exhibit rapid onset and short duration of action. We hypothesize that there will be less myocardial ischemia associated with the use of norepinephrine when compared with phenylephrine during carotid artery surgery.


Eligibility criteria: Inclusion Criteria:

* Elective carotid endarterectomy under general anesthesia
* \> 18 years old
* Written informed consent

Exclusion Criteria:

* Contraindication to general anesthesia
* Contraindication to transesophageal anesthesia
* esophageal disease
* esophageal stricture
* history of esophageal or gastric bleeding
* esophageal anatomic abnormality
* past esophageal or gastric surgery
* severe dysphagia

Primary outcomes:
measure: Myocardial ischemia measures by transesophageal echocardiography and ST segment analyses
Secondary outcomes:
measure: Myocardial ischemia measures by cardiac troponin I
Other outcomes:
Locations:
city: London
country: Canada
facility: University Hospital, LHSC
state: Ontario
Study officials:
affiliation: Associate Professor University of Western Ontario
name: Rosemary A Craen, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06949306: Intervention Study on Digital Health Management
Official title: Intervention of a Digital Health Management Program in Patients With Cardiometabolic Disorders: a Real-world Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypertension
Hyperlipidemia
Keywords: Cardiometabolic abnormalities
Digital Interventions
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2025-04-29
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to construct a digital precision intervention system for cardiometabolism disorders based on the characteristics of the Chinese population, focusing on the core components of metabolic syndrome such as hypertension, hyperglycemia, and obesity. Through dynamic monitoring of wearable devices, the individualized risk factors (including genetic predisposition, lifestyle, and psychological factors) of metabolic disorders were systematically analyzed, and dynamic intervention strategies were formulated accordingly. The closed-loop management of "monitor-feedback-optimization" based on the digital platform will provide patients with one-stop metabolic risk assessment and panoramic health management plan, realizing a paradigm shift from "generalized intervention" to "precise regulation". By reducing the abnormal fluctuations of key metabolic indicators such as blood pressure, blood glucose, and blood lipids, the risk of cardiovascular events will eventually be reduced, the long-term quality of life of patients will be improved, and a practical path of "digital therapy" can be promoted for the prevention and control of chronic diseases in China


Eligibility criteria: Inclusion Criteria:1. Age 18-65 years old; 2. Meet one of the following three conditions:

1. Diastolic hypertension (systolic blood pressure \< 140 MMHG and diastolic blood pressure ≥90mmHg)
2. Glycosylated hemoglobin (6.0-6.5)
3. Obesity (BMI≥28kg/m²)
4. Mild hyperlipemia: total cholesterol (TC) ≥5.2 mmol/L and \< 6.2 mmol/L, or low-density lipoprotein cholesterol (LDL-C) ≥3.4 mmol/L and \< 4.1 mmol/L 3. Antihypertensive or lipid-lowering medications have not been started 4. Use a smartphone and volunteer

Exclusion Criteria:

1. Complicated with chronic liver and kidney disease, coronary heart disease, heart failure and severe valvular disease
2. Previous cardiovascular and cerebrovascular events
3. Diastolic blood pressure ≥99mmHg
4. Glycated hemoglobin ≥6.5
5. Other life expectancy such as cancer is less than 5 years
6. Participate in other clinical trials

Primary outcomes:
measure: Changes in diastolic blood pressure after 24 weeks
timeFrame: 24 weeks following intervention
Secondary outcomes:
measure: Values for changes in Hba1c or BMI or CAI after 24 weeks
timeFrame: 24 weeks following intervention
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Cardiology,Shanghai Tenth People's Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT03503006: Effects of Vitamin D Status on the Outcome of Ivf - Embryo Transfer
Official title: Effects of Vitamin D Status on the Outcome of Ivf - Embryo Transfer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility, Female
Lead sponsor: Reproductive & Genetic Hospital of CITIC-Xiangya
Sponsor class: OTHER
First posted: 2018-04-19
Enrollment: 2569
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the study population will be selected from patients of Reproductive and Genetic Hospital of CITIC-Xiangya

Brief summary: At present, there is no agreement on the effect of vitamin D level in serum and follicular fluid on the outcome of IVF-ET pregnancy. Most of these studies were based on the research of total 25 (OH) D, which have ignored that the biological activity of vitamin D molecule is not total 25 (OH) D, but free vitamin D or vitamin D bioavailable, and have flaws in methodology. This project intends to make a prospective cohort study with large sample, based on a complete methodology of total vitamin D and free vitamin D to measure maternal vitamin D levels in blood,to systematically study the effect of maternal vitamin D status on IVF - ET pregnancy outcome. This study is also the first to study the relationship between maternal vitamin D status and the outcome of IVF-ET pregnancy using a complete methodology.


Eligibility criteria: Inclusion Criteria:

* female with only fallopian tube factor or male factor infertility,first IVF/ICSI cycle,18 years old≤age≤35 years old,take a long protocol or super-long protocol,18≤BMI≤25, menstrual regularity(periodic change \< 7 days)

Exclusion Criteria:

* Hyperprolactinemia, Thyroid dysfunction, uterine malformation ( inadequacy mediastinal uterus ≥1.0cm, Unicornate uterus, double uterus, T Angle of uterus, etc.), uterus adhesion, untreated hydrosalpinx , hysteromyoma（ hysteromyoma≥2.0 cm, and/or Uterine fibroids located within the endometrium≤1cm), endometriosis, diabetes, hypertension, adrenal cortex hyperplasia, Cushing's syndrome, a pituitary amenorrhea

Primary outcomes:
measure: clinical pregnancy rate
timeFrame: Until 28 day after embryo transferred
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Reproductive & Genetic Hospital of CITIC-XIANGYA
state: Hunan
Study officials:
References:
Clinical trial NCT02071706: Clinical Evaluation of an Integrated PET/MRI System
Official title: Clinical Evaluation of an Integrated PET/MRI System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subjects With Clinical Indication for PET/CT
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2014-02-26
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The investigational PET/MRI scanner, including attenuation correction method, is capable of producing diagnostic quality images and appropriate device functionality per user feedback.


Eligibility criteria: Inclusion Criteria:

1. Subject must have a clinical indication for a PET/CT exam
2. Subject must be at least eighteen (18) years of age; and
3. Female subjects that are determined to be non-pregnant by a physician investigator or are demonstrated non-pregnant by negative urine pregnancy test administered within the 24 hour period before PET/CT imaging; and
4. Subject must be able to hear and understand instructions without assistive devices; and
5. Subject must provide written informed consent; and
6. Subject has the necessary mental capacity to understand instructions, and is able to comply with protocol requirements; and
7. Subject is able to remain still for duration of imaging procedure (approximately 60 minutes total for PET/MRI); and
8. Subject must be able to participate in a PET/MR imaging session within 2 hours of concluding their PET/CT exam and within 4 hours of PET radiotracer administration.

Exclusion Criteria:

1. Subjects who have any axial diameter larger than 55 cm; or
2. Subjects with a weight greater than 227 kgs; or
3. Subjects that have metallic/conductive or electrically/magnetically active implants without MR Safe or MR Conditional labeling, with the exception of dental devices/fillings, surgical clips, and surgical staples determined to be safe for MRI scanning by a physician investigator; or
4. Subjects that have implants with MR Unsafe labeling; or
5. Subjects that have implants labeled as MR Conditional by the manufacturer for which the allowable conditions are not expected to be achieved by the MR/PET environment or scan protocol ; or
6. Subjects who have a contraindication to MRI according to the screening policy of the participating site

Primary outcomes:
measure: Number Usable PET/MRI Image Sets
timeFrame: 1 day
measure: Number of Diagnostic Quality Images
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: UniversitätsSpital Zürich
Study officials:
affiliation: GE Healthcare
name: Tibor Duliskovich, Medical Doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00121706: Fast Food Feeding in Youth
Official title: Fast Food Feeding in Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Harvard School of Public Health (HSPH)
First posted: 2005-07-21
Enrollment: 18
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The primary aim of the proposed pilot study is to assess the effects of fast food meals, varying in serving size and rate of delivery, on energy (calorie) intake in adolescents.

Detailed description: Using a three-period crossover design, the investigators will evaluate three acute feeding conditions.

* Under Condition A, the total amount of food in a large fast food meal will be delivered on a single tray at Time 0 (start of meal).
* Under Condition B, the same fast food meal will be equally divided among 4 separate portions, with all portions delivered at Time 0.
* Under Condition C, the meal again will be equally divided among 4 separate portions, but the portions will be delivered at 15-minute time intervals (Time 0, 15 minutes, 30 minutes, 45 minutes).

Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) between the 85th and 98th percentiles for sex and age
* Consumption of fast food at least one time per week
* Willingness to eat the foods specified in the research methods
* Parent/guardian willing and able to cooperate
* Access to a working telephone

Exclusion Criteria:

* Major medical illness (eg, diabetes; heart, renal, or liver disease; cancer; endocrinopathy)
* Taking any prescription medication that may affect food intake
* Current smoking (i.e., any tobacco in the last month)
* Previous diagnosis of an eating disorder

Primary outcomes:
measure: Energy (calorie) intake during fast food feedings, assessed by direct observation
Secondary outcomes:
measure: Energy (calorie) intake during the day of the visit and the day after the visit, assessed by multiple-pass dietary recall interview methodology
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Cara B Ebbeling, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Children's Hospital
name: David S Ludwig, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ebbeling CB, Sinclair KB, Pereira MA, Garcia-Lago E, Feldman HA, Ludwig DS. Compensation for energy intake from fast food among overweight and lean adolescents. JAMA. 2004 Jun 16;291(23):2828-33. doi: 10.1001/jama.291.23.2828.
Clinical trial NCT01052506: BIIB033 Single Ascending Dose Study in Healthy Volunteer Subjects
Official title: A Randomized, Blinded, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB033 in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Human volunteers
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2010-01-20
Enrollment: 72
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to evaluate the safety and tolerability of single dose of BIIB033 administered to healthy adult volunteers.

Detailed description: BIIB033 is an investigational product being developed to promote remyelination in subjects with multiple sclerosis (MS). This healthy volunteer study will evaluate safety and tolerability of a single dose of BIIB033.

Eligibility criteria: Inclusion Criteria:

* Must be in good health
* BMI of 18-30kg/m2
* Contraception required for at least 6 months after study drug administration

Exclusion Criteria:

* History of clinically significant disease or lab values
* Females of childbearing potentials
* Contraindication to brain MRI and/or lumbar puncture
* Treatment with any prescription medication within the 28 days prior to study entry
* Treatment with any over-the-counter products, including herbal and/or alternative health preparations and procedures within the 14 days prior to study entry
* Regular use of any tobacco product within 3 months prior to study entry

Primary outcomes:
measure: Safety as measured by adverse event monitoring, laboratory assessments and MRI
timeFrame: up to 4 months
measure: Tolerability as measured by adverse event monitoring, laboratory assessments and MRI
timeFrame: up to 4 months
Secondary outcomes:
measure: BIIB033 serum pharmacokinetics levels
timeFrame: up to 4 months
measure: BIIB033 serum antibodies levels
timeFrame: up to 4 months
measure: Exploratory blood, urine and CSF biomarkers
timeFrame: up to 4 months
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Research Site
state: California
city: Utrecht
country: Netherlands
facility: Research Site
Study officials:
References:
citation: Tran JQ, Rana J, Barkhof F, Melamed I, Gevorkyan H, Wattjes MP, de Jong R, Brosofsky K, Ray S, Xu L, Zhao J, Parr E, Cadavid D. Randomized phase I trials of the safety/tolerability of anti-LINGO-1 monoclonal antibody BIIB033. Neurol Neuroimmunol Neuroinflamm. 2014 Aug 21;1(2):e18. doi: 10.1212/NXI.0000000000000018. eCollection 2014 Aug.
Clinical trial NCT01690806: Dexamethasone for the Prevention of Recurrent Laryngeal Nerve Palsy
Official title: Dexamethasone for the Prevention of Recurrent Laryngeal Nerve Palsy (and Not Only) After Thyroid Surgery. A Randomized Double-blind Placebo-controlled Trial.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Benign Neoplasm of Thyroid Gland
Malignant Neoplasm of Thyroid
Lead sponsor: Università degli Studi dell'Aquila
Sponsor class: OTHER
First posted: 2012-09-24
Enrollment: 328
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients undergoing thyroid surgery for benign and malignant thyroidal disease

Brief summary: Recurrent laryngeal nerve dysfunction and hypoparathyroidism are well-recognized important complications of thyroid surgery. The duration of convalescence, after non complicated thyroid operation, may depend on several factors of which pain and fatigue are the most important. Nausea and vomiting occur mainly on the day of operation. Glucocorticoids are well known for their analgesic, anti-inflammatory, immune modulating and antiemetic effects. The investigators therefore undertook the present study to investigate whether preoperative dexamethasone could improve surgical outcome in patients undergoing thyroid surgery.


Eligibility criteria: Inclusion Criteria:

* patients undergoing thyroid surgery

Exclusion Criteria:

* ASA physical class III or IV
* age \> 75 years
* pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: L'Aquila
country: Italy
facility: ospedale San Salvatore-Reparto di Chirurgia Generale Universitaria
state: AQ
Study officials:
affiliation: Università degli Studi dell'Aquila
name: Emanuela M CECILIA, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schietroma M, Cecilia EM, Carlei F, Sista F, De Santis G, Lancione L, Amicucci G. Dexamethasone for the prevention of recurrent laryngeal nerve palsy and other complications after thyroid surgery: a randomized double-blind placebo-controlled trial. JAMA Otolaryngol Head Neck Surg. 2013 May;139(5):471-8. doi: 10.1001/jamaoto.2013.2821.