louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01151943: Comparison of Two Types of Pain Relief After Cesarean Delivery
Official title: Comparison of Two Methods of Pain Relief After Cesarean Delivery: Transversus Abdominis Plane (TAP) Block Versus Incisional Infiltration With Local Anesthetic
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Cesarean Section
Keywords: cesarean section
continuous wound infiltration
transversus abdominis plane block
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2010-06-29
Enrollment: 77
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Women undergoing elective cesarean delivery, performed under a standard spinal anesthesia, will be randomized to undergo either TAP block or incisional infiltration with local anesthetic, in addition to standard postoperative analgesia comprising regular acetaminophen, nefopam and ketoprofen. Short acting oral morphine will be given as a rescue treatment in case of severe pain.


Eligibility criteria: Inclusion Criteria:

* scheduled cesarean section performed under spinal anesthesia
* ASA I or II
* height above 1,55 m
* singleton pregnancy

Exclusion Criteria:

* contre indication to a drug used in the study (levobupivacaine, ketoprofen, nefopam)

Primary outcomes:
measure: severity of postoperative pain
timeFrame: 48 postoperative hours
Secondary outcomes:
measure: delay before the first rescue dose of morphine
timeFrame: 48 postoperative hours
measure: morphine requirement
timeFrame: 48 postoperative hours
measure: complication of each loco-regional technique
timeFrame: end of hospitalisation
measure: patient's satisfaction
timeFrame: end of hospitalisation
measure: length of hospital stay
timeFrame: end of hospitalisation
measure: occurrence of a neuropathic postoperative pain
timeFrame: 1 month postoperatively
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hôpital Foch
Study officials:
affiliation: Hôpital Foch
name: Marc Fischler, MD
role: STUDY_CHAIR
References:
citation: Chandon M, Bonnet A, Burg Y, Barnichon C, DesMesnards-Smaja V, Sitbon B, Foiret C, Dreyfus JF, Rahmani J, Laloe PA, Fischler M, Le Guen M. Ultrasound-guided Transversus Abdominis plane block versus continuous wound infusion for post-caesarean analgesia: a randomized trial. PLoS One. 2014 Aug 5;9(8):e103971. doi: 10.1371/journal.pone.0103971. eCollection 2014.
Clinical trial NCT03320343: Pilot Study of Measurement Agreement Between Morphological and Diffusion Tensor Imaging MRI for Pelvic Nerve Cartography
Official title: Pilot Study of Measurement Agreement Between Morphological and Diffusion Tensor Imaging MRI for Pelvic Nerve Cartography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pelvic MRI
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2017-10-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted to the Medical Imaging Department of the CHU Nîmes for an MRI examination of the pelvic region for any reason

Brief summary: The investigators hypothesize that diffusion tensor imaging (DTI) will produce a similar map of autonomic pelvic innervation to that obtained using 3D morphological MRI sequences


Eligibility criteria: Inclusion Criteria:

* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan
* The patient it at least 18 years old
* The patient has been admitted for an MRI examination of the pelvic region, for any reason

Exclusion Criteria:

* The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
* The subject refuses to sign the consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* The patient is pregnant or breast feeding
* There is a contra-indication for MRI (pacemaker, claustrophobic patient)
* The patient has had previous pelvic surgery

Primary outcomes:
measure: Agreement between DTI imaging measures versus 3D morphological MRI measures for point of penetration of the pelvic splanchnic nerves in the lower hypogastric plexus
timeFrame: Day 0
measure: Agreement between DTI imaging measures versus 3D morphological MRI measures for point of penetration of the pelvic hypogastric nerves in the lower hypogastric plexus
timeFrame: Day 0
measure: Agreement between DTI imaging measures versus 3D morphological MRI measures for origin of the cavernous nerves
timeFrame: Day 0
Secondary outcomes:
measure: Acquisition time
timeFrame: Day 0
measure: Time necessary for sequence reconstruction
timeFrame: Day 0
measure: Inter-operator agreement
timeFrame: Day 0
measure: Intra-operator agreement
timeFrame: Month 6
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU Nimes
Study officials:
References:
Clinical trial NCT02133443: NAVASET: Nava Level Titration Using Comfort Scales
Official title: Neurally Adjusted Ventilatory Assist (NAVA) Levels Titration During Weaning Using Ventilatory Comfort Scales: a Physiological Evaluation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Respiratory Failure
Keywords: Mechanical ventilation
Acute respiratory failure
Weaning
Pressure support ventilation
Neurally adjusted ventilatory assist
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
Collaborators: name: Centre d'Investigation Clinique et Technologique 805
First posted: 2014-05-08
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Determining the optimal Neurally Adjusted Ventilatory Assist (NAVA) level remains challenging, and several methods have been suggested. However none of them seems easily utilisable. Thus the investigators propose to test a way of NAVA level titration according to ventilator comfort.

Detailed description: Physiological comparison of different levels of ventilator assistance during Neurally Adjusted Ventilatory Assist (NAVA) to evaluate the effect of these on tidal volume, inspiratoy activity, comfort scales.

We propose to evaluate the ability to guide the titration according the patient's comfort scale. The intensity of the breathing sensations will be evaluated using the labeled visual analog scale (Banzett Scale).

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Hospitalized in intensive care unit for an acute respiratory failure
* Intubated or tracheotomized and mechanically ventilated
* RASS score: 0;-2
* Weaning period

Exclusion Criteria:

* Hemodynamic instability
* Absence of consent
* Contraindication of nasogastric catheter insertion

Primary outcomes:
measure: Comparison of ventilatory comfort with the physiological parameters when varying the levels of pressure support and Neurally Adjusted Ventilatory Assist (NAVA)
timeFrame: 24hr
Secondary outcomes:
measure: Efficiency
timeFrame: 24hr
measure: Efficiency
timeFrame: 24hr
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU de Caen
Study officials:
affiliation: University Hospital, Caen
name: Nicolas TERZI, MD-PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Garches
name: Frédéric Lofaso, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01564043: Internet Walking Program and Pedometer in Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Internet Access
Lead sponsor: VA Boston Healthcare System
Sponsor class: FED
Collaborators: name: University of Michigan
name: VA Ann Arbor Healthcare System
First posted: 2012-03-27
Enrollment: 31
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Higher levels of physical activity are associated with better functional status, fewer hospital admissions, and lower mortality. The investigators studied the feasibility and safety of a novel program that combines a pedometer with a website to increase walking. This is a pilot study.


Eligibility criteria: Inclusion Criteria:

* COPD
* able to ambulate
* internet access

Exclusion Criteria:

* current pulmonary rehab

Primary outcomes:
measure: Daily step count
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: VABoston Healthcare System
state: Massachusetts
Study officials:
References:
citation: Moy ML, Weston NA, Wilson EJ, Hess ML, Richardson CR. A pilot study of an Internet walking program and pedometer in COPD. Respir Med. 2012 Sep;106(9):1342-50. doi: 10.1016/j.rmed.2012.06.013. Epub 2012 Jul 12.
Clinical trial NCT05700643: Montmorency Cherry Supplementation, Sleep, and Inflammation
Official title: Effects of Montmorency Cherry Supplementation on Sleep and Inflammatory Outcomes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Insomnia Chronic
Inflammation
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: Cherry Marketing Institute
First posted: 2023-01-26
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will test the effects of Montmorency cherry supplementation on sleep outcomes and inflammatory biomarkers.


Eligibility criteria: Inclusion Criteria:

* body mass index (BMI) of ≥ 25.0 kg/m2;
* sleep issues as identified by a global score of 5 or greater on the Pittsburgh Sleep Quality Index (PSQI) and/or a score 8 or higher on the Insomnia Severity Index (ISI);
* ability to adhere to a diet low in antioxidants during the study period; and
* willingness to wear a Fitbit for the duration of the study and to wear the Zmachine on selected nights.

Exclusion Criteria:

* unwilling or unable to stop the use of sleep medication
* unable to attend laboratory visits on the East Lansing, Michigan campus

Primary outcomes:
measure: Change in total sleep time
timeFrame: Through study completion, two weeks for each arm
measure: Change in sleep quality
timeFrame: Through study completion, two weeks for each arm
measure: Change in insomnia symptoms
timeFrame: Through study completion, two weeks for each arm
Secondary outcomes:
measure: Change in C-reactive protein
timeFrame: Through study completion, two weeks for each arm
measure: Change in Interleukin-6
timeFrame: Through study completion, two weeks for each arm
measure: Change in Interleukin-8
timeFrame: Through study completion, two weeks for each arm
measure: Change in Interleukin-17
timeFrame: Through study completion, two weeks for each arm
measure: Change in Tumor necrosis factor-alpha
timeFrame: Through study completion, two weeks for each arm
measure: Change in Anthropometrics
timeFrame: Through study completion, two weeks for each arm
Other outcomes:
Locations:
city: East Lansing
country: United States
facility: Michigan State University
state: Michigan
Study officials:
References:
Clinical trial NCT02412943: Pappalysin 2 (PAPP-A2) Enzyme Replacement
Official title: PAPP-A2 Enzyme Replacement Therapy Using Plasma Transfusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Short Stature, Idiopathic
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2015-04-09
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study evaluates the transfusion of fresh frozen plasma containing the enzyme PAPP-A2 into the a female adult. This female adult has a mutated version of PAPP-A2 that prevents the unbinding of IGF-1 from IGF binding proteins. The investigator's hypothesize that transfusion of plasma with donor PAPP-A2 will lead to the unbinding of IGF-1 from its binding proteins and that they will be able to measure free IGF-1 in the blood of this female adult.

Detailed description: PAPP-A2 is a plasma protease that is known to cleave IGFBP-3 and IGFBP-5. It is thought that this cleavage frees up IGF-1 from its bound form allowing it to become the active free IGF-1. The participant has short stature accompanied with elevated plasma levels of both IGF-1 and IGF binding protein 3 (IGFBP-3). Genetic analysis of the participant identified a novel missense mutation in PAPPA2 (Ala1033Val). This gene is a perfect candidate to explain our patients' phenotype. The investigators' hypothesis is that loss of activity of PAPP-A2 leads to an inability to cleave the IGF binding proteins and thus an overall elevation in IGFBP-3 and consequent elevation in total IGF-1. However, this IGF-1 cannot be freed up and is thus not able to be active leading to short stature. The patient's missense variant is predicted to be damaging by in silicon prediction models such as Polyphen2. Furthermore, two knock out mouse models of PAPPA2 as well as a zebrafish knock out exist, all showing growth retardation (post-natally in the mice). Taken together, this is definitive evidence that the patients' mutation in PAPPA2 is responsible for their short stature phenotype.

Eligibility criteria: Inclusion Criteria:

* Homozygous for a defect in PAPPA2.

Exclusion Criteria: None

Primary outcomes:
measure: Decrease in IGF-1
timeFrame: 5 minutes
Secondary outcomes:
measure: Length of decrease in IGF-1
timeFrame: up to 30 days
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Andrew Dauber, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04613843: Cold Water Immersion Stirring in Hyperthermic Individuals
Official title: Cold Water Immersion Stirring in Hyperthermic Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperthermia
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2020-11-03
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, counterbalanced, crossover design
Primary purpose: TREATMENT

Brief summary: The best way to cool a very hot person is using cold water immersion, however, the optimization of this technique has not been established. The goal of this study is to determine differences in cooling rates among two types of cold water immersion and passive cooling following immersion.


Eligibility criteria: Inclusion Criteria:

* 18-39 y old men and women
* Self-reported to be healthy
* Currently completes aerobic exercise at least 30 minutes a day, at least 2 days per week

Exclusion Criteria:

* History of any cardiovascular, neurologic, renal, or metabolic disease
* History of any contraindications on the CoreTemp contraindications and warnings document
* Current tobacco use or regular use within the last 2 years
* Taking medications with known thermoregulatory or cardiovascular effects (e.g., aspirin, beta blockers, diuretics, psychotropics, etc.)
* History of exertional heat stroke
* Currently pregnant or breastfeeding
* Inability to follow the rules of the protocols or understand the consent form

Primary outcomes:
measure: Cooling rate
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Center for Research and Exercise in Special Environments
state: New York
Study officials:
References:
Clinical trial NCT06938243: Wether VNS in Early Stage (3 Months) is Safe and More Beneficial for Post-stroke Motor Rehabilitation
Official title: The Comparison of Safety and Treatment Results Between Early (<6 Months) and Late (> 6 Months) Vagus Stimulation for Post-stroke Motor Rehabilitation: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Stroke
Motor Rehabilitation
Keywords: Hemiparesis
VNS
Limb Motor Function Rehabilitation
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2025-04-22
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Upper-extremity impairment after stroke remains a major therapeutic challenge and a target of neuromodulation treatment efforts. In previous study, Vagus nerve stimulation was constricted to patients 9 months after stroke. In this randomized phase I trial, we would apply vagus nerve stimulation in an early stage (\<6 month) and observe its theraputic effect on motor function after ischaemic Stroke.We hypothesized that the early stimulation could be safe and more beneficial compared to stimulation in late stage.


Eligibility criteria: Inclusion Criteria:

* Eligible individuals suffered a first-time, unilateral, ischemic stroke in the middle cerebral artery territory that spared the diencephalon and basal ganglia 3-36 months before surgery.

  * Individuals with persistent moderate-to-severe upper-extremity hemiparesis as defined by an FM-UE score of ≤42
  * Sufficient upper-extremity motor ability to engage in rehabilitation (that is, a score of ≥1 on the FM-UE elbow flexion, elbow extension or finger mass flexion or extension).

Exclusion Criteria:

* Excessive spasticity or contracture of the upper-extremity muscles (that is, Modified Ashworth Scale = 4) . Severe cognitive impairment (Mini Mental State Examination \< 24)

Primary outcomes:
measure: FM-UE scores between early and late VNS
timeFrame: 12 months after device implantation
Secondary outcomes:
measure: Arm Motor Ability Test (AMAT) between early and late VNS
timeFrame: 12 months after device implantation
measure: the Nine-Hole Peg Test between early and late VNS
timeFrame: 12 months after device implantation
measure: the Bilateral Box and Block Test between early and late VNS
timeFrame: 12 months after device implantation
measure: Short Form Health Survey (SF-12) between early and late VNS
timeFrame: 12 months after device implantation
measure: the EuroQol Five Dimensions Questionnaire (EQ-5D) between early and late VNS
timeFrame: 12 months after device implantation
measure: safety and feasibility of early and late VNS
timeFrame: 12 months after device implantation
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Sichuan
Study officials:
References:
Clinical trial NCT02233543: A Multicenter, 4-week Crossover (Total Duration 12 Weeks) to Determine the Impact of QVA149 on Nocturnal Oxygen Levels in Chronic Obstructive Pulmonary Disease (COPD)
Official title: A Multicenter, 4-week Crossover (Total Duration 12 Weeks), Placebo-controlled, Double-blind Study to Determine the Impact of QVA149 (Indacaterol/Glycopyrronium) 85/43 µg on Nocturnal Oxygen Levels in Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
QVA149
nocturnal oxygen levels
combination bronchodilator
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2014-09-08
Enrollment: 38
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to determine whether a fixed dose combination of indacaterol and glycopyrronium (QVA149) has an impact on night-time blood oxygen levels in Chronic Obstructive Pulmonary Disease.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of COPD (according to GOLD guidelines, updated 2014) with a post-bronchodilator FEV1/FVC \<0.70
* Patients with a post-bronchodilator FEV1 ≥30% and \<60% of the predicted normal value
* Resting daytime oxygen saturation levels measured by pulse oximetry of ≤95% SpO2
* Smoking history of at least 10 pack years (Ten pack-years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years)

Exclusion Criteria:

* An exacerbation of COPD (treatment with oral or parenteral antibiotics and/or glucocorticosteroids and/or hospitalization related to COPD) within 4 weeks prior to screening or during the run-in period
* Diagnosed asthma
* Patients receiving regular long term oxygen therapy (LTOT)
* Ongoing / planned rehabilitation during the study period
* Three or more awakenings during the night leading to toilet visit or other reasons for exiting the bed during the last week prior to the screening visit due to non-COPD reasons

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Mean Night-time Blood Oxygenation
timeFrame: Post 4 weeks administration of QVA149, post 4 weeks administration of placebo
Secondary outcomes:
measure: Percent of Time Spent During the Night Below 90 % in Blood Oxygen Saturation
timeFrame: Post 4 weeks administration of QVA149, post 4 weeks administration of placebo
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Novartis Investigative Site
city: Hvidovre
country: Denmark
facility: Novartis Investigative Site
city: Bergen
country: Norway
facility: Novartis Investigative Site
city: Goteborg
country: Sweden
facility: Novartis Investigative Site
city: Uppsala
country: Sweden
facility: Novartis Investigative Site
Study officials:
References: