louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05892874: Impact of Postoperative Medical Equipment Removal/insertion on Parental Anxiety in Pediatric Cardiac Intensive Care Unit
Official title: Impact of Postoperative Medical Equipment Removal/insertion on Parental Anxiety in Pediatric Cardiac Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parents
Anxiety Postoperative
Lead sponsor: Claude Bernard University
Sponsor class: OTHER
Collaborators: name: Research on Healthcare Performance Lab U1290
First posted: 2023-06-07
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parents of minor patients suffering from congenital cardiopathy, hospitalized for electuve surgical procedures

Brief summary: A lot of observationnal studies describe parental stressors in PICU/PCICU, but none studied, prospectively, the links between medical equipment removal/insertion and anxiety modulation.

The primary objective is to identify the impact of medical equipment removal/insertion on the STAI-Y score (anxiety) The secondary objective is to identify the parental anxiety determinant (via VAS).

Detailed description: A lot of observationnal studies describe parental stressors in Paediatric Intensive care Unit, but none studied, prospectively, the links between medical equipment removal or insertion and anxiety modulation.

The primary objective is to identify the impact of medical equipment removal or insertion on the STAI-Y score (anxiety) The secondary objective is to identify the parental anxiety determinant (via Visual Analog Stress Scale.

Parents will fill out questionnaire upon arrival in the Intensive care unit when reaching the bedside of their hospitalized child right after the elective cardiac surgery. Then after each equipment removal or insertion they will be asked to fill out again the same questionaire.

Eligibility criteria: Inclusion Criteria:

* parents/legal tutor of minor patient (congenital cardiopathy) with elective hospitalization in PCICU for surgical procedures

Exclusion Criteria:

* Parents no french speaking
* child hospitalized for Cardiac Catheterization
* child hospitalized for Berlin Heart insertion
* child hospitalized for heart transplantation

Primary outcomes:
measure: State Trait Anxiety Index - Y version
timeFrame: at the arrival in the intensive care unit
Secondary outcomes:
measure: Visual Analogic Scale
timeFrame: at the arrival in the intensive care unit
Other outcomes:
Locations:
city: Bron
country: France
facility: Unit 11 Hospices Civils of Lyon
state: Rhône-Alpes
Study officials:
affiliation: Hospices Civils of Lyon
name: Vincent Piriou, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00822874: Influence of a Prematuration Culture With a Phosphodiesterase-3 Inhibitor (PDE3-I) on Embryonic Aneuploidy Rate and Developmental Potential
Official title: Influence of a Prematuration Culture With a PDE3-I on Embryonic Aneuploidy Rate and Developmental Potential - a Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Infertility
Keywords: PCOS and normal ovulatory patients
aneuploidy
in-vitro maturation of oocytes
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2009-01-15
Enrollment: 115
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: A single centre randomised controlled trial investigating the influence of a novel prematuration system (PMS) using a phosphodiesterase-3 inhibitor for in-vitro maturation of oocytes - pilot study.


Eligibility criteria: Inclusion Criteria:

* healthy volunteers, either with PCOS/PCOS-like ovaries, or with normal ovaries, who undergo oocyte donation for research
* AFC at least 10
* AMH: \> 5 μg/L
* Female age \< 36 years

Exclusion Criteria:

* major uterine or ovarian abnormalities

Primary outcomes:
measure: Incidence of aneuploidy rate by fluorescence in situ hybridisation (FISH) technique in 6 to 8 cell embryos from prolonged (PMC) IVM compared to conventional IVM on sibling oocytes.
timeFrame: 3 days after egg retrieval
Secondary outcomes:
measure: Implantation potential of embryos from conventional IVM performed on Type II COC. Efficiency of both maturation systems in obtaining blastocysts. Endometrium quality in IVM cycles.
timeFrame: 7 days after egg retrieval
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Centre for Reproductive Medicine
Study officials:
References:
Clinical trial NCT03755674: CHRONOtype-adjusted DIET on Weight Loss
Official title: Influence of Chronobiological and Neuroendocrine Factors in Appetite Regulation and Obesity Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Appetite regulation
Chronotype
Diet
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
Collaborators: name: Hospital Universitario Virgen de la Arrixaca
First posted: 2018-11-28
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: BACKGROUND: Several reports have observed that the alteration of normal biological rhythms is associated with obesity development. In this regard, those subject with the preference for evening seems to be prone to develop obesity. However, the current treatment of obesity does not take into account these aspects OBJECTIVE: To evaluate whether a diet adjusted to patient's chronotype is more effective than the current dietary recommendations.

SUBJECTS/METHODS: 209 subjects take part in a randomized, double-blind clinical trial. 104 subjects followed a typical hypocaloric dietary treatment (CONTROL) and the other 105 subjects undergone a diet with a daily caloric distribution adjusted to their chronotype (CHRONO).

CONCLUSIONS: A chronotype-adjusted diet may be a promising alternative to the classical hypocaloric dietary treatment since the investigator's data indicate a higher effectiveness regarding weight loss when the diet was adjusted to the patient's chronotype.


Eligibility criteria: Inclusion Criteria:

* students or staff of the Catholic University of Murcia (UCAM), with an age ranged between 18 and 65 years old

Exclusion Criteria:

* clinically significant illnesses (including type 2 diabetes, chronic heart failure, hepatitis and cancer)
* those taking any medications known to affect body weight (thyroid hormones, corticosteroids, etc.)
* women in special physiological situations (pregnant, lactating).

Primary outcomes:
measure: Total weight loss, in percentage, from baseline to end-of-treatment
timeFrame: 12 weeks
Secondary outcomes:
measure: BMI loss
timeFrame: 12 weeks
measure: Anthropometrical and other clinical parameters
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Universidad Católica San Antonio de Murcia
name: Juan José Hernández Morante, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Galindo Munoz JS, Gomez Gallego M, Diaz Soler I, Barbera Ortega MC, Martinez Caceres CM, Hernandez Morante JJ. Effect of a chronotype-adjusted diet on weight loss effectiveness: A randomized clinical trial. Clin Nutr. 2020 Apr;39(4):1041-1048. doi: 10.1016/j.clnu.2019.05.012. Epub 2019 May 21.
Clinical trial NCT06822374: Hypertonic Saline in Posterior Spinal Fusion
Official title: Use of a Buffered 2% Hypertonic Saline Solution During Posterior Spinal Fusion
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Scoliosis Idiopathic
Scoliosis;Congenital
Keywords: intraoperative fluid resuscitation
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 75
Sex: ALL
Minimum age (years): 10
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, randomized study in patients greater than or equal to 10 years of age scheduled for an posterior spinal fusion that requires invasive monitoring of arterial blood pressure. Subjects will be randomized to receive either standard of care Normosol-R or buffered 2% hypertonic saline for intraoperative fluid resuscitation.

The primary objective of this study is to compare intraoperative changes in acid-base status and electrolytes based on the type of fluid administered intraoperatively.

The secondary objective is to compare the volume of fluid required and use of adjunctive volume resuscitation with 5% albumin for intraoperative resuscitation when using standard Normosol-R or a novel buffered 2% saline solution.


Eligibility criteria: Inclusion Criteria:

* Patients \> or = 10 years of age
* ASA 1-3
* Undergoing a PSF procedure requiring two peripheral intravenous infusions and an arterial cannula

Exclusion Criteria:

* Arterial cannula is not indicated for the surgical procedure
* Two peripheral intravenous cannulas are not required
* An invasive arterial cannula cannot be placed

Primary outcomes:
measure: pH
timeFrame: Every 1-2 hours during the surgery
measure: Base deficit
timeFrame: Every 1-2 hours during the surgery
measure: Sodium
timeFrame: Every 1-2 hours during the surgery
measure: Ionized calcium
timeFrame: Every 1-2 hours during the surgery
measure: Potassium
timeFrame: Every 1-2 hours during the surgery
Secondary outcomes:
measure: Fluid volume
timeFrame: Duration of surgery (approx. 4-6 hrs.)
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's
state: Ohio
Study officials:
References:
Clinical trial NCT00354874: Investigation Of A New Medication (GW642444) In Asthmatic Patients
Official title: A Multi-centre, Randomised, Double-blind, Placebo Controlled, Dose Ascending, Four Way Crossover Study to Examine Efficacy (FEV1), Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single and Repeat Doses of GW642444
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: GW642444 asthmatic subjects safety tolerability PD and PK
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-07-20
Enrollment: 28
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 study will evaluate efficacy (FEV1), safety, tolerability, pharmacodynamics and pharmacokinetics of single and repeat inhaled doses of GW642444. This will be a multi-centre, double-blind, placebo controlled, dose ascending, four way cross-over study in approximately 28 mild to moderate asthmatic subjects.

Key assessments: Efficacy, safety, tolerability, pharmacodynamics and pharmacokinetics will be assessed by measurement of FEV1, blood pressure, heart rate, 12-lead ECGs, clinical laboratory tests, collection of adverse events (AE) information and blood samples.


Eligibility criteria: Inclusion criteria:

* Female subjects must be non-childbearing (i.e., surgically sterilised or post-menopausal).
* Non-smokers for at least 6 months.
* Stable asthma.

Exclusion criteria:

* Abnormal findings on heart monitoring assessment.
* Lower respiratory tract infection within 4 weeks, upper respiratory tract within 2 weeks of study.
* Currently taking doses of fluticasone propionate over 500mcg/day.
* Unstable asthma medication.

Primary outcomes:
measure: FEV1 at 24 hours after a single dose.
timeFrame: 24 hours on 4 separate occasions
Secondary outcomes:
measure: FEV1 - Days 1 and 7
timeFrame: Days 1 and 7 on 4 separate occasions
measure: Mean morning/evening PEFR
timeFrame: Days 3-8 on 4 separate occasions
measure: BP, HR & QTc on Days 1 and 7
timeFrame: Days 1 and 7 on 4 separate occasions
measure: Potassium and glucose on Days 1 and 7
timeFrame: Days 1 and 7 on 4 separate occasions
measure: safety & tolerability as measured by AEs, laboratory safety tests, cardiac monitoring, VS & ECG
timeFrame: throughout study
measure: PK parameters
timeFrame: Days 1, 4 and 7 on 4 separate occasions
Other outcomes:
Locations:
city: Wiesbaden
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Grosshansdorf
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Göteborg
country: Sweden
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05743374: Micronutrient and Additive Modifications May Optimize Diet To Health
Official title: Micronutrient and Additive Modifications May Optimize Diet To Health
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ulcerative Colitis
Diet Habit
Microbial Colonization
Keywords: Ulcerative colitis
Diet
Microbiota
Emulsifying agent
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2023-02-24
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized intervention study with elimination of putatively harmful substances in the diet
Primary purpose: OTHER

Brief summary: This is a prospective clinical intervention trial where patients with moderately active ulcerative colitis are randomized to either normal healthy diet or a diet with elimination of emulsifying agents within the E 400-group with special respect to carragenan, CMC and polysorbates. At study start and end after one month their diet, clinical characteristics and microbiota will be analysed. The hypotheses are that their disease activity measured with calprotectin and their microbiota will improve after intervention.

Detailed description: Patients with ulcerative colitis attending the out-patient clinic at Skåne university hospital with calprotectin 100-600 will be invited to participate in this diet intervention study. They will be divided into two arms with 35 patients in each, normal diet or E-400 elimination. The diet will be recorded at study start and end with a food diary for four days and a food frequency questionnaire regarding E-400 intake. The patients clinical characteristics (demographics) and disease activity (diarrhoea frequency, blood in stools, abdominal pain, CRP and calprotectin) will be recorded and microbiota collectted. The hypotheses are that the activity measured with clinical characteristics and calprotectin as well as their microboita measured with dysbiosis index and total genom with NGS will improve significantly.

Eligibility criteria: Inclusion Criteria:

* Ulcerative colitis,
* Moderately active
* Stable medication

Exclusion Criteria:

* Severe disease
* Recent surgery
* Proctitis
* Pregancy
* Treatment with antibiotics
* Difficulties in understanding the information about the study
* Multimorbidity that makes it impossible to participate

Primary outcomes:
measure: Calprotectin
timeFrame: One month
measure: Microbiota diversity
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Region Skåne
state: Skåne
Study officials:
affiliation: Dept of Gastroenterology, SUS, Malmö, Sweden
name: Klas Sjöberg, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03135574: Prevalence of a High-intensity Signal of the Oculomotor Nerve on T2 MRI Sequence in Patients With Ophthalmoplegia
Official title: Prevalence of a High-intensity Signal of the Oculomotor Nerve on T2 MRI Sequence in Patients With Ophthalmoplegia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ophthalmoplegia
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2017-05-01
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients (18 years of age or older) benefiting from an MRI, requested by the ophthalmologist for an assessment of an ophthalmoplegia.

Brief summary: Oculomotor nerve (third cranial nerve or III) palsy is a relatively frequent cause of consultation in ophthalmology.

It may reveal a life-threatening pathology such as aneurysm rupture, pituitary apoplexy, and therefore need imaging in emergency. Apart from few extreme emergency situations, MRI of the oculomotor tract is the first-line examination required. In the usual clinical practice, the investigators noticed in several patients unusual areas of high-intensity signal within the oculomotor nerve on T2 sequence, observed in various locations along the nerve path (cavernous and/ or intra-orbital segment). This abnormal signal, at the best knowledge of the investigators, has never been reported in the literature and could confirm the nerve impairment.

In patients with ophthalmoplegia involving probably the third cranial nerve, disclosing this new MRI sign could help (i) to confirm the involvement of the oculomotor nerve and eliminate differential diagnoses such as myasthenia (ii) to orientate the etiological diagnosis (inflammatory or ischemic origin). A T2 sequence focused on the III could thus be systematically included in the usual MRI protocol.


Eligibility criteria: Inclusion Criteria:

* Ophthalmoplegia whatever the clinical form (unilateral or not, isolated or not, sudden or progressive onset)

Exclusion Criteria:

* Absolute contraindication to MRI or injection of contrast agents

Primary outcomes:
measure: High-intensity signal of the oculomotor nerve on MRI T2 sequence (presence or absence, determined by a radiologist)
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique A. de Rothschild
Study officials:
References:
Clinical trial NCT06226974: Acute Effects of Static Stretching on the Shoulder Joint Position Sense of Overhead Athletes
Official title: Acute Effects of Static Stretching on the Shoulder Joint Position Sense of Overhead Athletes: a Randomized Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Static Stretching
Joint Position Sense
Proprioception
Shoulder
Overhead Athletes
Lead sponsor: University Fernando Pessoa
Sponsor class: OTHER
First posted: 2024-01-26
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of the study is to investigate the acute effects of static stretching on the shoulder joint position sense of overhead athletes.

Detailed description: A crossover randomized controlled trial will be conducted with 17 overhead athletes (9 males and 8 females). All of them will perform the 3 study conditions in random order: a control (5-minute rest), and static stretching of 30 or 90 seconds of muscles around the shoulder. The shoulder joint position sense will be assessed before and immediately after these conditions, and tested by active repositioning for the range of 110º of flexion, with a video camera. Absolute, relative and variable angular errors will be calculated.

Eligibility criteria: Inclusion Criteria:

* Subjects aged between 18 and 30 years
* Competitive overhead athletes (basketball, handball, volleyball, swimming)
* Normal range of motion of flexion of the shoulder

Exclusion Criteria:

* History of injury of the shoulder joint in the previous 6 months
* Positive shoulder joint integrity tests (anterior drawer; fulcrum test; Jerk test; and sulcus sign)

Primary outcomes:
measure: Absolute angular error
timeFrame: Change from Baseline (Before) to Immediately after interventions or control (After)
measure: Relative angular error
timeFrame: Change from Baseline (Before) to Immediately after interventions or control (After)
measure: Variable angular error
timeFrame: Change from Baseline (Before) to Immediately after interventions or control (After)
Secondary outcomes:
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Escola Superior Saúde Fernando Pessoa
Study officials:
References:
Clinical trial NCT01214174: Efficacy and Safety Study of IBI-10090 in Cataract Surgery Patients
Official title: A Multicenter, Randomized, Double-masked, Dose-ranging, Phase 2 Study to Evaluate the Efficacy and Safety of IBI-10090 in Treating Inflammation in Cataract Surgery Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Ocular Inflammation
Keywords: cataract
inflammation
Lead sponsor: ICON Bioscience Inc
Sponsor class: INDUSTRY
First posted: 2010-10-04
Enrollment: 42
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will test the efficacy and safety of IBI-10090 in the treatment of ocular inflammation after cataract surgery.


Eligibility criteria: Inclusion Criteria:

* Male or female patients 40 years of age scheduled for unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation.

Exclusion Criteria:

* Patients who have used any ocular, topical, or oral corticosteroids within 7 days prior to Day 0.
* Patients who have used topical ocular NSAIDs in the study eye within 15 days prior to screening.
* Patients with any signs of intraocular inflammation in either eye at screening.
* Patients who have received any prior intravitreal injections in the study eye.

Primary outcomes:
measure: Proportion of Patients With Anterior Chamber Cell Clearing at Day 8 Post-Treatment
timeFrame: 8 days post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Eugene
country: United States
facility: Drs. Fine, Hoffman, and Packer
state: Oregon
Study officials:
affiliation: Drs. Fine, Hoffman, Packer
name: Mark Packer, MD
role: PRINCIPAL_INVESTIGATOR
References: