louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00627081: Effect of Thoracic Epidural Analgesia on Intravenous Closed-Loop Anesthesia
Official title: Intravenous Opioid-sparing Effect of Thoracic Epidural Administration of Chirocaine (5 mg/ml) During Thoracotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: General Anesthesia
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2008-02-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The association of general anesthesia and of thoracic epidural anesthesia is used in thoracic surgery with a demonstrated benefit on the risk of postoperative respiratory complications.

The objective of the study is to analyze the influence of thoracic epidural administration of chirocaine (5 mg/ml) on the administration of anesthetic agents (propofol and remifentanil), these drugs being administrated using a closed-loop system with the Bispectral Index as the controller.

Two groups of patients are compared:

* one group will receive general anesthesia and thoracic epidural administration of saline. Chirocaine will be administered before patient's awakening,
* one group will receive general anesthesia and thoracic epidural administration of chirocaine (5 mg/ml).

In both groups, the closed-loop system ensures that le depth of anesthesia is similar in both groups.


Eligibility criteria: Inclusion Criteria:

* patients undergoing a thoracotomy under general anesthesia and epidural anesthesia

Exclusion Criteria:

* age lower than 18 years,
* pregnant woman,
* psychotropic treatment,
* central neurological disorder or lesion cerebral,
* allergy to propofol or to a muscle relaxant,
* refusal or contra-indication of epidural anesthesia,
* severe emphysema,
* coronary disease,
* treatment with a beta-blocker or a vasoactive drug.

Primary outcomes:
measure: amount of remifentanil delivered by the closed-loop system
timeFrame: end of anesthesia
Secondary outcomes:
measure: amount of propofol delivered by the closed-loop system
timeFrame: end of anesthesia
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hôpital Foch
Study officials:
affiliation: Hopital Foch, 92150 Suresnes, France
name: Marc Fischler, MD
role: STUDY_CHAIR
References:
citation: Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloe PA, Trillat B, Barvais L, Fischler M. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology. 2006 Apr;104(4):686-95. doi: 10.1097/00000542-200604000-00012.
Clinical trial NCT02349581: Ultrasound Guided Pectoral Nerves Blockade for Persistent Pain After Breast Cancer Surgery
Official title: Ultrasound Guided Pectoral Nerves (Pecs) Blockade in Persistent Pain After Breast Cancer Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Persistent Pain After Breast Cancer Surgery
Keywords: Anesthetics, Local
Mastectomy
Neuralgia
Nerve block
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Kehlet, Henrik, M.D., Ph.D.
First posted: 2015-01-29
Enrollment: 6
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a pilot study of the pectoral nerves block (PECS) in patients with persistent pain after breast cancer surgery.

Detailed description: This study is in 2 parts: Part 1 is a description of the anatomy of the PECS block in pain free, unoperated patients using ultrasonography (non invasive). Part 2 is the administration of the block to patients that have persistent pain after breast cancer surgery. Before and after the block we will take a detailed pain history and do neurophysiological tests called quantitative sensory testing (QST). These tests assess the patients' ability to feel warmth, cold and test their thresholds for pain. The block is then administered using ultrasound guidance and 20mls of 0.25% bupivacaine is injected in the pectoral muscles on the side with pain. Thirty minutes after the block, the pain is re assessed and the QST is repeated.

Eligibility criteria: Inclusion Criteria:

* Female patients, aged 18 years or over, treated for breast cancer
* Patients with persistent pain in the breast after surgical treatment for breast cancer. Their pain score must be 4 or more on the numerical rating scale (NRS).

Exclusion Criteria:

* breast surgery within the last 12 months
* previous cosmetic surgery
* bilateral breast cancer (receiving bilateral intervention)
* pregnant or breast feeding
* neurological disease
* on-going treatment for severe mental illness or who abuse alcohol or drugs
* are unable to understand written or spoken Danish or English
* lack mental capacity to give informed consent or cooperate with the neurophysiological testing
* an allergy to amide local anaesthetics
* pacemaker in situ
* received treatment outside guidelines and recommendations from the Danish Breast Cancer Co-operative Group (DBCG)

Primary outcomes:
measure: Differences in summed pain intensity score (SPI)
timeFrame: 30 minutes after blockade
Secondary outcomes:
measure: Differences in quantitative sensory testing (QST) values
timeFrame: 30 minutes after blockade
Other outcomes:
measure: Longer term effects (Daily pain scores and functional questionnaire)
timeFrame: 1 week after blockade
Locations:
city: Copenhagen
country: Denmark
facility: Section for surgical pathophysiology 7621 Rigshospitalet
state: Sjaelland
Study officials:
affiliation: Rigshospitalet, Denmark
name: Henrik Kehlet, MD, PhD, DMsc
role: STUDY_DIRECTOR
References:
Clinical trial NCT02032381: Prospective Study of Belated Pulmonary Complications Occurring in Children Treated With Allogeneic Hematopoietic Stem Cells.
Official title: Prospective Study of Late Pulmonary Complications Occurring in Children Treated With Allogeneic Hematopoietic Stem Cells.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Marrow Transplant Infection
Bronchiolitis Obliterans
Chronic Respiratory Insufficiency
Organizing Pneumonia
Pulmonary Cytolytic Thrombi
Keywords: non infectious pulmonary complications after hematopoietic cell transplant
functional respiratory test and exercise test
thoracic tomodensitometry
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2014-01-10
Enrollment: 300
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Hematopoietic stem cell transplantation (HSCT) is used to treat an expanding array of malignant and non-malignant disorders. This is a prospective multicenter study, in pediatric allo-BMT recipients to analyze the spectrum of noninfectious pulmonary complications (PC), to evaluate the prevalence and course of PFT abnormalities before and after transplant, and to detect risk factor for PC.

Detailed description: It's a multicenter prospective study in France. All children under 18 years are included, just before the HSCT. The functional test before the HSCT at 6, 12, 18, 24, 30 and 36 months will be collected and a cardiopulmonary exercise test is done one and three years after the HSCT. Thoracic tomodensitometry is done before the HCT and after at 6, 12, 24 and 36 months.

All data will be collected upon the HSCT, the infections before and after the HSCT, the respiratory symptoms, and the treatment. Bronchia alveolar lavage and serum will be collected and frozen during the study.

The inclusion will be done during two years and children will be following during three years.

The purpose is to evaluate the prevalence, the course of PFT abnormalities before and after transplant, and to detect risk factor for PC.

Eligibility criteria: Inclusion Criteria:

* Age: from birth to 18 years
* Patient to be treated by allogeneic hematopoietic stem cell - Parents who have given their signed consent for the study
* Affiliation to a social security scheme

Exclusion Criteria:

* non exclusion criteria

Primary outcomes:
measure: Presence of belated non-infectious pulmonary complications
timeFrame: 3 years
Secondary outcomes:
measure: Presence of risk factors for belated non-infectious pulmonary complications
timeFrame: 3 years
measure: Survival three years
timeFrame: 3 years
measure: Severity of respiratory disease
timeFrame: 3 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Houdouin véronique
Study officials:
affiliation: APHP
name: Houdouin Véronique, MD PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06480981: Multiple Ascending Dose Noribogaine PK/PD in Healthy Volunteers
Official title: A Randomized, Double-blind, Placebo-controlled Trial to Evaluate Multiple Dose Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Ascending Doses of Noribogaine in Healthy Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Lead sponsor: DemeRx NB
Sponsor class: INDUSTRY
First posted: 2024-07-01
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: This trial will be a randomised, double-blind, sequential-group, multiple-dose, placebo-controlled, dose escalation trial to characterise the pharmacokinetics (PK), pharmacodynamics (PD) and safety of noribogaine in healthy adult participants.


Eligibility criteria: Inclusion Criteria:

* Ability to provide written, personally signed, and dated informed consent.
* Healthy male and female participants between the ages of 18 to 45 inclusive.
* BMI 18 - 30 kg/m2.
* Non- or ex-smoker.
* Normal ECG findings i.e. QTcF interval ≤ 450 ms and normal morphology that would permit accurate assessment of the QT interval.
* Participants must agree to use highly

Exclusion Criteria:

* History of, or concurrent clinically significant cardiovascular, dysautonomia, gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic or psychiatric, or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the participant or impact the validity of the study.
* Family history in first degree relatives for unknown and/or known arrhythmia-related cardiac events, cardiomyopathy, syncope, long QT syndrome, Brugada's syndrome, sudden death attributed to cardiac causes, and familial cardiac channelopathies.
* Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with interpretation of QTc interval changes.
* Previous or current alcohol, or other drug dependence.

Primary outcomes:
measure: Pharmacokinetics Cmax
timeFrame: Day 1 to Day 8
measure: Pharmacokinetics Tmax
timeFrame: Day 1 to Day 8
measure: Pharmacokinetics AUC0-t
timeFrame: Day 1 to Day 8
measure: Pharmacokinetics AUC0-infinity
timeFrame: Day 1 to Day 8
measure: Pharmacokinetics t1/2
timeFrame: Day 1 to Day 8
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Richmond Pharmacology
Study officials:
affiliation: Richmond Pharmacology
name: Jorg Taubel
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01725581: A Study to Test a New Pelvic Examination Assessment Tool
Official title: A Study to Test the Validity and Reliability of an Objective Structured Assessment of Technical Skills in Pelvic Examination
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Female Pelvic Examination
Keywords: OSAT
Pelvic Examination
Validation
Reliability
Lead sponsor: Birmingham Women's NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2012-11-14
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Medical students and junior doctors will be approached by the clinical sub dean for O\&G at Birmingham Women's Hospital (Justin Clark - chief investigator) during the beginning of their O\&G placement. They will be made aware that outcome and assessment as part of the trial will not be incorporated into their final academic grade.

Brief summary: The purpose of this study is to show that a new assessment tool for pelvic examination is valid and reliable.

Detailed description: Physical examination of the pelvis is an important core skill that medical students need to acquire. However, due to its intimate nature some students are graduating unable to perform competent pelvic examinations. At present, evaluation of the medical students competence at pelvic examination is done by subjective faculty assessment. This assessment is typically performed at the end of the teaching block and is based on the assessors' recollection of the students' performance. This kind of assessment has been shown to have poor validity and reliability. This is in contrast to objective structured assessments of technical skill (OSATS), which use task specific and global rating scales and have been used to evaluate a wide range of clinical and surgical skills. However, no studies to date have evaluated an assessment tool for pelvic examination. In this study the investigators aim to determine the validity and reliability of an OSATS for pelvic examination. In addition, the investigators aim to identify factors that influence the scores in OSATS.

Eligibility criteria: Inclusion Criteria:

* Final year medical students starting their Obstetrics and Gynaecology placement
* Final year medical students finishing their Obstetrics and Gynaecology placement
* Pre Royal College of Obstetrics and Gynaecology registered junior doctors doing a Obstetrics and Gynaecology placement.
* Signed Consent Form

Exclusion Criteria:

• None

Primary outcomes:
measure: Validity of assessment tool
timeFrame: Day 1
measure: Reliability of assessment tool
timeFrame: Day 1
Secondary outcomes:
measure: Factors other than the stage in training that may influence proficiency in pelvic examination
timeFrame: Day 1
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Birmingham Womens Hospital
state: West Midlands
Study officials:
affiliation: Birmingham Women's NHS Foundation Trust
name: Thomas J Clark, MBChB MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01154881: A Trial Evaluating the Blood Glucose-lowering Effect of NN1250 in Subjects With Type 2 Diabetes
Official title: A Trial Evaluating the Pharmacodynamic Response of NN1250 at Steady State in Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2010-07-01
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial was conducted in Europe. The aim of this clinical trial was to evaluate the blood glucose-lowering effect of NN1250 (insulin degludec/insulin 454) in subjects with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus (as diagnosed clinically) for at least 12 months
* Body mass index (BMI) below or equal to 35.0 kg/m2

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
* Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

Primary outcomes:
measure: Area under the glucose infusion rate curve from 0-24 hours at steady state
timeFrame: 0-24 hours (derived on treatment day 6)
Secondary outcomes:
measure: Area under the insulin degludec concentration-time curve from 0-24 hours at steady state
timeFrame: 0-24 hours (derived on treatment day 6)
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Heise T, Nosek L, Bottcher SG, Hastrup H, Haahr H. Ultra-long-acting insulin degludec has a flat and stable glucose-lowering effect in type 2 diabetes. Diabetes Obes Metab. 2012 Oct;14(10):944-50. doi: 10.1111/j.1463-1326.2012.01638.x. Epub 2012 Jul 10.
citation: Heise T, Korsatko S, Nosek L, Coester HV, Deller S, Roepstorff C, Segel S, Kapur R, Haahr H, Hompesch M. Steady state is reached within 2-3 days of once-daily administration of degludec, a basal insulin with an ultralong duration of action. J Diabetes. 2016 Jan;8(1):132-8. doi: 10.1111/1753-0407.12266. Epub 2015 Mar 24.
Clinical trial NCT06490510: Prognostic Significance of Mutation Type and Chromosome Fragility in Fanconi Anemia
Official title: Prognostic Significance of Mutation Type and Chromosome Fragility in Fanconi Anemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fanconi Anemia
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2024-07-08
Enrollment: 227
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Fanconi anemia included in the Spanish Registry

Brief summary: The goal of this observational study is to analyze the data included in the Spanish Registry of Patients with Fanconi anemia to better understand the natural history of the disease, identify genetic risk and prognostic factors, and identify potential therapeutic strategies.


Eligibility criteria: Inclusion Criteria:

* All patients in the Spanish Registry of Patients with Fanconi Anemia

Exclusion Criteria:

-

Primary outcomes:
measure: Description of the clinical evolution of the patient
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau - IIB Sant Pau
Study officials:
affiliation: Institut de Recerca Sant Pau (IR SANT PAU), Barcelona, Spain
name: Jordi Surrallés, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05006781: The Dose Finding Study of DAOIB Added to tDCS for AD
Official title: The Dose Finding Study of Sodium Benzoate Added to tDCS for the Treatment of Early-phase Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
Conditions: Transcranial Direct Current Stimulation
Dementia
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2021-08-16
Enrollment: 140
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a 26-week randomized, double-blind, placebo-controlled trial. We will enroll patients with aMCI or mild AD. All patients will receive 2 weeks of tDCS (5 sessions per week, 10 sessions in total) during the first 2 weeks of the study, and will also be allocated randomly to either of 4 treatment groups for 24 weeks: (1) Dose A group; (2) Dose B group; (3) Dose C group; (4) placebo group. We will assess the patients every 8 weeks during the treatment period (weeks 0, 10, 18, and 26). We hypothesize that augmentation with certain dose of DAOIB will yield better effect than tDCS alone in improving the cognitive function, global functioning and quality of life in patients with aMCI or mild AD.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Alzheimer's disease or mild cognitive impairment
* MMSE between 10-26
* CDR 1 or 0.5

Exclusion Criteria:

* Hachinski Ischemic Score \> 4
* Substance abuse/dependence
* Parkinson disease, epilepsy, dementia with psychotic features
* Major depressive disorder
* Major physical illnesses
* Severe visual or hearing impairment

Primary outcomes:
measure: Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 10, 18 and 26
timeFrame: week 0, 10, 18, 26
Secondary outcomes:
measure: Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 10, 18 and 26
timeFrame: week 10, 18, 26
measure: Change from baseline in Mini-Mental Status examination score at week 10, 18 and 26
timeFrame: week 0, 10, 18, 26
measure: Change from baseline in Alzheimer's disease Cooperative Study scale for ADL in MCI (ADCS-MCI-ADL) score at week 10, 18 and 26
timeFrame: week 0, 10, 18, 26
measure: Change from baseline in Quality of life score at week 10, 18 and 26
timeFrame: week 0, 10, 18, 26
measure: Change from baseline in the composite score of a battery of additional cognitive tests at week 26
timeFrame: week 0, 26
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
References:
Clinical trial NCT05379010: Endodontic Microsurgery With the Use of L-PRF Block
Official title: Endodontic Microsurgery With the Use of L-PRF Block: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Apical Periodontitis
Apical Periodontal Cyst
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2022-05-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the effect of leucocyte and platelet rich fibrin Block (L-PRF Block) during endodontic microsurgery (EMS) on patient's post-operative comfort and periapical bone healing in large peri-apical lesions.

Detailed description: This study evaluates the effect of leucocyte and platelet rich fibrin Block (L-PRF Block) during endodontic microsurgery (EMS) on patient's post-operative comfort and periapical bone healing in large peri-apical lesions. The trial design is an open randomized controlled clinical trial with two groups. Half of the participants will receive EMS with L-PRF Block (experimental group), the other half without (control group).

Eligibility criteria: Inclusion Criteria

* Provision of Informed Consent
* Patients from 18 years old
* Patients in need of an EMS
* EMS is the only option to cure the periapical lesion
* A periapical lesion that has a diameter of 10mm or more in sagittal plane, frontal plane or axial plane when measured on CBCT

Exclusion Criteria

* Unlikely to be able to comply with the study procedures, as judged by the investigator
* Orthograde endodontic (re)treatment is indicated
* Known or suspected current malignancy
* History of chemotherapy within 5 years prior to study
* History of radiation in the head and neck region
* History of other metabolic bone diseases
* History of bleeding disorders
* HIV disease
* Hepatitis B or C
* Systemic disease (osteoporosis, diabetes...)

Primary outcomes:
measure: Amount of peri-apical bone healing
timeFrame: 1 year
Secondary outcomes:
measure: Patient related outcomes
timeFrame: 7 days
measure: Patient related outcomes
timeFrame: 7 days
measure: Patient related outcomes
timeFrame: 7 days
measure: Bone or scar tissue healing
timeFrame: 1 year
measure: Success & survival rate
timeFrame: 1 year
measure: Dentinal defects
timeFrame: 1 year
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-Brabant
Study officials:
affiliation: UZ Leuven
name: Nastaran Meschi, DDS
role: PRINCIPAL_INVESTIGATOR
References: