louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06346236: Neurodevelopmental Impact of Treatment in Hypothyroxinaemia of Prematurity.
Official title: Neurodevelopmental Impact of Treatment in Hypothyroxinaemia of Prematurity.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transient Hypothyroxinemia of Prematurity
Keywords: transient hypothyroxinaemia of prematurity, THOP, preterm, prematurity, neurodevelopment, L-thyroxine, ASQ score
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 373
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Reanimation and intensive care units of neonatology in Auvergne-Rhone Alpes region (Lyon Croix Rousse hospital, Lyon Femme mère Enfant hospital, St Etienne Hopital Nord, Grenoble Hopital couple enfant).

Brief summary: Nowadays, taking care of preterm birth is associated with an important increase in survival. This increased survival comes with impairment in neurodevelopmental outcomes in long term evaluation. Thyroid hormones are essentials for brain development, especially for neuronal differentiation. Transient hypothyroxinaemia of prematurity (THOP) is a frequent condition defined by decreased thyroid hormones without the expected rise in thyroid stimulating hormone. Various studies have showed various results regarding the consequences of THOP on neurodevelopment in premature neonates. However, the biggest and most powerful studies agree to say that THOP impair neurodevelopment. On the other hand, only a few studies evaluated the impact of treatment of THOP, and only two focused on treating exclusively the neonates with a biological diagnosis of THOP (Suzumura and co. in 2010 and Nomura and co. in 2014) and their results are inconsistent.

In this study, we aim to show that a treatment with L-thyroxine at a dose of 7.5 µg/kg/j for neonates diagnosed with THOP (defined as a level of l-T4 \< 12 pmol/L and a level of TSH \< 15 mUI/L before 15 days of life or \< 85 mUI/L after 15 days of birth) is associated with an increased neurodevelopmental prognosis.


Eligibility criteria: Inclusion Criteria:

* Premature infants born before or at 3032 weeks of gestation
* For whom blood sample for thyroid examination has been performed for routine care during his stay in neonatology unit.

Exclusion Criteria:

* Other type of thyroid dysfunction (including, but not exclusively: mother with Basedow disease, congenital hypothyroidism, hyperthyroidism)
* Associated polymalformative sindrome

Primary outcomes:
measure: Neuro-development judged " abnormal " by the paediatrician during the two years of corrected age's consultation.
timeFrame: Evaluation at two years of corrected age.
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: HFME
city: Grenoble
country: France
facility: CHU Grenoble
city: Saint-Étienne
country: France
facility: CHU Saint EtienneHopital
Study officials:
References:
Clinical trial NCT04911036: Study of the Effect of the Time of Diagnosis (Antenatal vs. Postnatal) on the Post-traumatic Reactions of Parents of Children Undergoing Oesophageal Atresia Surgery "
Official title: Study of the Effect of the Time of Diagnosis (Antenatal vs. Postnatal) on the Post-traumatic Reactions of Parents of Children Undergoing Oesophageal Atresia Surgery "
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atresia, Esophageal
Keywords: Esophageal atresia
post-traumatic reactions
early accompaniment
Perinatal Posttraumatic Stress Disorder Questionnaire
cross-sectional study in psychology
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2021-06-02
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Be a mother and/or a father of a living child aged between 12 and 24 months who has undergone neonatal surgery following a diagnosis of type 1 or type 3 EA

Brief summary: This is an observational, national multicentre (34 centres involved), cross-sectional study in psychology whose objective is to describe and compare the levels of post-traumatic reactions of mothers to the announcement of their child's EA diagnosis.

An ancillary study will be carried out among the fathers present who agree to participate in the study.


Eligibility criteria: Inclusion Criteria:

* Be the mother and/or a father of a living child aged 12 to 24 months who has undergone neonatal surgery following the diagnosis of type 1 or type 3 EA;
* Not to have objected to participating in the study (information and non-objection form signed by the investigator);
* To be socially insured.

Exclusion Criteria:

* Woman or man whose child with AO has a chromosomal abnormality;
* Woman or man whose child with AO has a polymalformative syndrome;
* Female or male minor ;
* Pregnant woman;
* Woman or man who does not speak French;
* Woman or man unable to consent, or benefiting from a legal protection regime (guardianship or curatorship);
* Woman or man deprived of liberty.

Primary outcomes:
measure: Perinatal Posttraumatic Stress Disorder Questionnaire (score PPQ)
timeFrame: at 2 months
Secondary outcomes:
measure: Percentage of mothers with Score PPQ >5
timeFrame: at 2 months
measure: Questionnaire on early support
timeFrame: at 2 months
measure: Correlation between STAI-Trait, Questionnaire on early support and Score PPQ evaluated to mothers
timeFrame: at 2 months
measure: Correlation between STAI-Trait, Questionnaire on early support and Score PPQ evaluated to fathers
timeFrame: at 2 months
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Jeanne de Flandre Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: Véronique Debarge, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06862336: Interdialytic Resistance Exercises in with Chronic Kidney Diseases
Official title: Intradialytic Versus Interdialytic Resistance Exercises on Quality of Life in Patients with Chronic Kidney Diseases
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Kidney Diseases
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Fifty chronic kidney disease patients' ages will range from 40 to 55 years. They will be selected from the dialysis unit. received intra-dialytic combined exercise program for 8 weeks(3 sessions/week), with their medical treatment.


Eligibility criteria: Inclusion Criteria:

1. Fifty patients with CKD, are on hemodialysis for longer than threemonths 3 sessions/ week.
2. Theirageswillrangefrom40 to 55yearsold.
3. Their body mass index is more than 18.5 and less than 29.9 %.

3-All patients have hemodynamic stability over the month before beginning the program.

Exclusion Criteria:

* 1. Severe Chest diseases(either obstructive or restrictive). 2. Clinical signs of a severe cardiac event.(eg, severe atherosclerosis, congestive heart failure), 3. Severepsychiatricorcognitiveimpairment,whounabletofollowcomment. 4. Neurological disorders affecting respiratory muscles or any muscular dystrophies(cervical disc or bulge).

  5. Patients with severe self-limiting illness (e.g., cancer). 6. peripheral artery disease in lower extremities. 7. Systolic blood pressure \< 180 mmHg, diastolic blood pressure more than 105 mmHg, or heart rate above 120 bpm during dialysis.

  8. Patient with uncontrolled- diabetes.

Primary outcomes:
measure: Measuring quadriceps and cuff muscles power
timeFrame: pre intervention and re assessed after 2 months of treatment
Secondary outcomes:
measure: Kidney disease quality of life F
timeFrame: pre intervention and re assessed after 2 months of treatment
measure: chest expansion
timeFrame: pre intervention and re assessed after 2 months of treatment
measure: Six-minute walk test
timeFrame: pre intervention and re assessed after 2 months of treatment
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT03607136: Early Detection of Disability and Health Promotion for Community-dwelling Elderly
Official title: Department of Physical Therapy, Tzu Chi University
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Elderly
Sarcopenia
Keywords: early detection
health promotion
community-dwelling
elderly
Lead sponsor: Buddhist Tzu Chi General Hospital
Sponsor class: OTHER
First posted: 2018-07-31
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluates the effects of exercise intervention on muscle strength and walking speed for the community-dwelling elderly. Half of the participants will receive exercise training, while the other half will maintain their usual activities of daily living.

Detailed description: Physical inactivity can result in physical frailty and sarcopenia. Physical frailty and sarcopenia are two common and mostly overlapping geriatric conditions, which may cause negative consequences of aging, such as disability, hospitalization and mortality.

Regular physical activity has been suggested to maintain or improve functional capacity and body composition, as well as delay aging process. Nevertheless, inactivity prevalence still significantly increases among older adults, especially those with a disability. One of the probable reasons is that the use of physical activities or exercise interventions is not tailored to the needs and capabilities of the elderly.

Eligibility criteria: Inclusion Criteria:

* age greater than 50 years
* able to follow simple instructions
* willing to participate and sign consent form

Exclusion Criteria:

* unstable angina or epilepsy
* severe visual deficits
* cognitive dysfunction
* other musculoskeletal conditions that will limit mobility

Primary outcomes:
measure: Walking speed
timeFrame: Change from baseline at 12 weeks
measure: Muscle strength
timeFrame: Change from baseline at 12 weeks
Secondary outcomes:
measure: Timed up and go test
timeFrame: Change from baseline at 12 weeks
measure: Walking endurance
timeFrame: Change from baseline at 12 weeks
measure: Sit-to-stand test
timeFrame: Change from baseline at 12 weeks
measure: Berg balance scale
timeFrame: Change from baseline at 12 weeks
measure: Gait kinematics
timeFrame: Change from baseline at 12 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02378636: Clinical Investigation of the Modified Rayner Monofocal Aspheric 600C (With Axis Marks) Intraocular Lens
Official title: Clinical Investigation of the Modified Rayner Monofocal Aspheric 600C (With Axis Marks) Intraocular Lens
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cataract
Lead sponsor: Rayner Intraocular Lenses Limited
Sponsor class: INDUSTRY
Collaborators: name: Visioncare Research Ltd.
First posted: 2015-03-04
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This will be a prospective, open-label, 125 subject (maximum), two-year multicentre investigation to assess the safety, effectiveness and rotational stability of the modified 600C (axis marks) intraocular lens (IOL) in subjects undergoing cataract extraction.


Eligibility criteria: Inclusion Criteria:

* Male or female aged ≥21 years of age.
* Cataract for which phacoemulsification extraction and posterior IOL implantation has been planned for the operative eye.
* Best corrected distance visual acuity (BCDVA) projected to be better than 20/30 (+0.18 logMAR) in the operative eye after cataract removal and IOL implantation.
* Calculated IOL power requirement within the range +8.0 to +34.0D
* If present, subject must have corneal astigmatism of \<1.50 D in the operative eye.
* Expected dilated pupil size ≥ 5.0 mm in diameter to visualise the axis markings
* Subject must provide written informed consent.
* Subject must be able to return for scheduled follow-up examinations for 24 months after surgery.

Exclusion Criteria:

* History of ocular trauma or prior ocular surgery in the operative eye.
* Microphthalmia
* Corneal decompensation or endothelial insufficiency
* Pseudo exfoliation
* Pars planitis
* Subjects with diagnosed degenerative visual disorders in the operative eye (e.g.,macular degeneration or other retinal disorders) that are predicted to cause future visual acuity losses to a level of 20/30 (+0.18 logMAR) or worse.
* Inability to achieve secure placement in the designated location e.g. absence of a secure peripheral anterior capsule, zonule laxity or dehiscence; posterior synechiae to the capsular bag
* Active ocular disease in the operative eye, e.g., clinically significant dystrophy, chronic severe uveitis, proliferative diabetic retinopathy, or chronic glaucoma.
* Concurrent participation in another drug or device investigation.
* Patients who are expected to require retinal laser treatment.
* Females who are pregnant, nursing or plan to become pregnant during the study.

Primary outcomes:
measure: Best Corrected Distance Visual Acuity (BCDVA)
timeFrame: 180 Day
measure: Rotational Stability
timeFrame: 180 Day
Secondary outcomes:
Other outcomes:
Locations:
city: Hove
country: United Kingdom
facility: Contact Rayner Intraocular Lenses Limited for Locations
state: East Sussex
Study officials:
affiliation: Consultant
name: Mark Packer, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01840254: Effect of Combination Dexmedetomidine Added to Fentanyl-based Intravenous Patient-controlled Analgesia on Nausea Vomiting in Highly Susceptible Patients Undergoing Lumbar Spinal Surgery: Prospective Double Blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PONV
Keywords: PONV
IV PCA
dexmedetomidine
Female
non-smoking
lumbar spine surgery
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-04-25
Enrollment: 108
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to test the hypothesis that addition of dexmedetomidine to fentanyl-based intravenous patient controlled analgesia (PCA) reduces requirement of fentanyl bolus and consequent postoperative nausea and vomiting in high-risk patients undergoing lumbar spine surgery.


Eligibility criteria: Inclusion Criteria:

1. female, non-smoking patient who are 20-65 of age scheduled for elective lumbar spine surgery

Exclusion Criteria:

1. Bradycardia on EKG (45bpm)
2. Atrioventricular conduction disorder
3. Uncontrolled hypertension
4. angina history
5. obesity (BMI ≥ 30 kg/m2)
6. Preoperative administration of opioid
7. Preoperative administration of antiemetics
8. Gastrointestinal disorder history
9. Hepatic or renal disease
10. Pregnant 11. Foreigner

Primary outcomes:
measure: total dose and bolus administration of opioid
timeFrame: an expected average of 48 hrs for requirements of total dose and number of bolus administration of PCA
Secondary outcomes:
measure: consequent postoperative nausea and vomiting
timeFrame: an expected average of 48 hrs for assessing of the 11-points verbal numerical rating scales
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University College of Medicine
Study officials:
References:
citation: Song Y, Shim JK, Song JW, Kim EK, Kwak YL. Dexmedetomidine added to an opioid-based analgesic regimen for the prevention of postoperative nausea and vomiting in highly susceptible patients: A randomised controlled trial. Eur J Anaesthesiol. 2016 Feb;33(2):75-83. doi: 10.1097/EJA.0000000000000327.
Clinical trial NCT01550354: Comparison Among Propofol, Alfentanil and Rocuronium as Adjunct to Sevoflurane Anesthesia for Endotracheal Intubation in Children With Frenectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankyloglossia
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-03-12
Enrollment: 114
Sex: ALL
Minimum age (years): 1
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Several methods have been demonstrated to improve intubating conditions during sevoflurane induction in children. These include opioids, propofol, and addition of neuromuscular blocking agents in pediatric patients. But the study about the comparison of these agents has been uncommon. Frenectomy is common procedure to treat ankyloglossia. It is a short procedure performed under general anesthesia. The investigators aimed to compare intubating conditions among children with propofol, alfentanil or rocuronium after sevoflurane induction.


Eligibility criteria: Inclusion Criteria:

* Children, 1-9 years old scheduled elective frenectomy under general anesthesia

Exclusion Criteria:

* Patients with an abnormal airway, reactive airway disease, gastroesophageal reflux disease, chronic respiratory disease, or a history of an upper respiratory tract infection in the preceding 6-week period

Primary outcomes:
measure: Intubating condition
timeFrame: Participants will be followed for the duration of intubation, an expected average of 1 minute.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance hospital
Study officials:
References:
citation: Park S, Kim JH, Bae JC, Lee JR, Kim MS. Tracheal intubation with or without a neuromuscular blocking agent for a short surgical procedure in children: Prospective, randomized, double-blind trial. Paediatr Anaesth. 2021 Aug;31(8):863-870. doi: 10.1111/pan.14205. Epub 2021 Jun 3.
Clinical trial NCT00410254: HCV-796 and Midazolam Drug Interaction Study in Healthy Subjects
Official title: An Open Label, Single-Dose Midazolam, Multiple-Dose HCV-796, Sequential 3-Period Study to Determine the Pharmacokinetics of the Potential Drug Interaction Between HCV-796 and Midazolam
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-12-12
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the potential PK interaction of multiple oral doses of HCV-796 and a single oral dose of midazolam when coadministered to healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy as determined by investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs and 12-lead ECG.

Primary outcomes:
measure: Safety PK
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
state: Florida
city: Philadelphia
country: United States
state: Pennsylvania
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05261854: Effect Of Pressure Biofeedback on Deep Cervical Muscle Training Among University Teachers.
Official title: Effects of Pressure Biofeedback on Deep Cervical Flexor Muscle Training for Neck Pain, Functional Disability and Muscle Endurance Among University Teachers. A Randomized Control Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: Neck pain
Disabilty
Muscle endurance
Pressure biofeedback
Teachers
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 100
Sex: ALL
Minimum age (years): 24
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effect of pressure biofeedback on deep cervical muscle in university teachers suffering from neck pain, Functional Disability and muscle endurance.

Detailed description: The purpose of this study will be to determine whether training of deep cervical flexor muscles with pressure biofeedback has any significant advantage over conventional training for pain and disability experienced by university teachers with neck pain. This study will be a randomized control trial with double blinded protocol. Patient will be randomly allocated in two groups. the experimental group received deep cervical flexor muscles training with pressure biofeedback and conventional exercises. The control group received deep cervical flexor muscles training with only conventional exercises.

Eligibility criteria: Inclusion Criteria:

* Both gender
* age between 24 to 45 years
* At least 4 years of teaching experience and average 8 hours of working per day
* Chronic Neck pain score of more than 5 on numeric pain rating scale
* Mild to moderate disability Score on neck disability index

Exclusion Criteria:

* Participants with any ongoing treatment for neck pain
* History of cervical spine surgery or reported any neurological signs.
* History of any congenital or acquired postural deformity, spinal cord compression, tumour, instability, fracture, inflammatory disease or infection.

Primary outcomes:
measure: Numeric pain rating Scale
timeFrame: 8th week
measure: Inclinometer
timeFrame: 8th week
measure: Cranio-cervical flexion test
timeFrame: 8th week
measure: Neck Disability index
timeFrame: 8th week
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalabad
country: Pakistan
facility: Riphah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Kashif
role: STUDY_CHAIR
References: