louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03992092: Video Stylet vs. Flexible Bronchoscopy for C-Spine
Official title: Comparison of Video Stylet to Flexible Bronchoscopy for Intubation of Patients With Potential Cervical Spine Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intubation;Difficult
Intubation Complication
Keywords: cervical spine injury
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2019-06-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel randomised controlled trial
Primary purpose: TREATMENT

Brief summary: Comparison of cervical spine movement during intubation with the C-MAC Video Stylet to Flexible Bronchoscopy

Detailed description: Elective surgical patients who require intubation will be randomised to one of 2 groups:

1. C-MAC Video Stylet
2. Flexible Bronchoscopy During intubation, fluoroscopy will be recorded for later analysis to determine the amount of cervical spine movement during the intubation process.

The intubation will also be timed to determine the duration of the intubation process.

Eligibility criteria: Inclusion Criteria:

* Elective Surgery requiring oral intubation
* undergoing elective non-cardiac surgery
* American Society of Anesthesiologists physical status 1-3
* age 18-80 years

Exclusion Criteria:

* gastro-esophageal reflux disease
* body mass index \> 35 kg/m2
* possibility of pregnancy
* previous neck surgery
* unstable C-spine
* known or predicted difficult airway.

Primary outcomes:
measure: Time to Intubation
timeFrame: Concurrent, during the intubation
Secondary outcomes:
measure: C-Spine Movement
timeFrame: Concurrent, during the intubation
measure: Sore Throat
timeFrame: 24-48 hours post-op.
measure: Vocal Changes
timeFrame: 24-48 hours post-op.
measure: Ease of Intubation
timeFrame: Concurrent, during the intubation
Other outcomes:
Locations:
city: London
country: Canada
facility: University Hospital
state: Ontario
Study officials:
affiliation: LHSC
name: Timothy Turkstra, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02976792: Effectiveness of the NephroCheck™ After TAVI
Official title: Effectiveness of the NephroCheck™ to Predict Postoperative Acute Kidney Injury in Patients Undergoing a Transcatheter Aortic Valve Implantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transcatheter Aortic Valve Implantation
Acute Kidney Injury
Postoperative Acute Renal Failure
Keywords: Transcatheter aortic valve implantation
Acute Kidney Injury
early acute kidney injury detection
Nephrocheck™
Renal Resistive Index
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2016-11-29
Enrollment: 62
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: Patients undergoing a TAVI procedure

Brief summary: Postoperative acute renal failure is a frequent complication after a Transcatheter Aortic Valve Implantation (TAVI). The current practice cannot predict Acute Kidney Injuries (AKI) early enough to prevent an organic dysfunction triggering, consequently, cortical tubular necrosis.

Several recent studies in cardiac surgery have shown that sonographic criteria, the Renal Resistive Index (IRR), and a urinary biomarker, the NephroCheck™, could predict AKI promptly. These markers, sonographic and biologic, have both the advantage to be non-invasive and easy to perform. Each marker seems to have sensitivity and specificity to predict AKI promptly after cardiac surgery. Therefore, the IRR and the NephroCheck™ test could become essential tests to guide clinicians in determining rapidly whether a patient will develop AKI after a TAVI procedure. However, so far, no study has tested the NephroCheck™ in patients undergoing TAVI.

Therefore, the aim of this prospective observational study will be first to determine the effectiveness of the NephroCheck™ to predict AKI at an early stage after a TAVI procedure. The secondary outcome will be to compare the NephroCheck™ with the RRI in predicting at an earlier stage than the traditional method an AKI.


Eligibility criteria: Inclusion Criteria:

* patients scheduled to undergo a TAVI

Exclusion Criteria:

* Chronic dialysis patients with anuria

Primary outcomes:
measure: Effectiveness of the NephroCheck™ test to detect AKI after TAVI
timeFrame: Evolution of the Nephrocheck test from the time 0 to time 2.(Time 0: at inclusion before the TAVI / Time 1: NephroCheck™ Test at the first micturition post TAVI / Time 2: NephroCheck test™ on the first post operative day at the first micturition.)
Secondary outcomes:
measure: Renal Resistive Index compared with NephroCheck™
timeFrame: Evolution of the Renal Resistive Index from time 0 to time 2. Time 0: at inclusion before the TAVI / Time 1: at the first micturition post TAVI/ Time 2: on the first post operative day at the first micturition.
Other outcomes:
Locations:
city: Pessac
country: France
facility: BORDEAUX UNIVERSITY HOSPITAL - Haut Lévêque
Study officials:
affiliation: head of anesthesia department II
name: Alexandre OUATTARA, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02125292: Taste Assessment Study of SHP429 in Healthy Adult Subjects
Official title: A Phase 1, Open-label, Randomized, 3-period Crossover Taste Assessment Study to Characterize the Palatability of SHP429 When the Contents Are Sprinkled Onto Soft Foods or Emptied Into a Cup and Administered With Water in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2014-04-29
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to compare the palatability of SHP429 capsule contents delivered via 3 means of administration (sprinkled on yogurt, sprinkled on applesauce, and emptied into a cup and administered with water).


Eligibility criteria: Inclusion Criteria:

* normal, healthy, adult male and female volunteers, without evidence of active or chronic disease

Primary outcomes:
measure: Number of Participants With Positive Responses to Palatability Assessment of The Taste of Mesalamine
timeFrame: Immediately post-dose
measure: Number of Participants Who Detected an Aftertaste of Mesalamine
timeFrame: 5 minutes post-dose
measure: Number of Participants With Positive Responses to Palatability Assessment of The Aftertaste of Mesalamine
timeFrame: 5 minutes post-dose
measure: Number of Participants Willing to Take Mesalamine Via Treatment Method on a Regular Basis
timeFrame: Immediately post-dose
Secondary outcomes:
measure: Number of Participants Who Experienced an Adverse Event
timeFrame: 4 days
measure: Number of Participants With Potentially Clinically Important Laboratory Results
timeFrame: 1 day
measure: Number of Participants With Potentially Clinically Important Vital Signs
timeFrame: 1 day
measure: Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Results
timeFrame: 1 day
Other outcomes:
Locations:
city: Miami
country: United States
facility: Clinical Pharmacology of Miami, Inc.
state: Florida
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00717392: Evaluation of the Efficacy of Hippotherapy for Children With Developmental Disorders
Official title: Evaluation of the Efficacy of Hippotherapy for Children With Developmental Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Attention Deficit Hyperactivity Disorder
Autism Spectrum Disorder
Keywords: ADHD
ASD
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2008-07-17
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hippotherapy subjects will be taken from horseback riding farms. Control subjects will be taken from a tertiary care clinic.

Brief summary: Hippotherapy is every program of horseback riding meant to treat people with physiological, mental, social, cognitive or behavioral problems. The purpose of the current research is to evaluate the efficacy of hippotherapy for children with developmental disabilities. The hypothesis is that children with developmental disabilities who are treated with hippotherapy will show better outcomes than children with the same problems who are not treated with hippotherapy.

Detailed description: Hippotherapy is every program of horseback riding meant to treat people with physiological, mental, social, cognitive or behavioral problems. Most studies that tested hippotherapy were uncontrolled and focused on motor problems, such as cerebral palsy. Today, hippotherapy is used for various developmental problems such as Attention deficit / Hyperactivity disorder (ADHD) and Autism spectrum disorder (ASD), without clear information about its efficacy for these populations.

The purpose of the current research is to evaluate the efficacy of 6 months of hippotherapy for children with developmental disabilities. The hypothesis is that children with developmental disabilities who are treated with hippotherapy for 6 months will show better outcomes than children with the same problems who are not treated with hippotherapy.

Assessment:

* BRIEF questionnaire
* Stony Brook Questionnaire

All questionnaires will be applied at the beginning of the study and after 6 months.

Eligibility criteria: Inclusion Criteria:

* Age: 5-17 years.
* A diagnosis of ADHD or ASD.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Improving the parameters of autism
timeFrame: Repetitive behaviors
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat-Gan
country: Israel
facility: Weinberg Child Development Center, Sheba Medical Center, Tel-Hashomer
Study officials:
affiliation: Sheba Medical Center
name: Lidia Gabis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06264492: Delving Into Participation Trends of Scleroderma Clinical Trials
Official title: Deciphering Patient Participation: Insights From Observational Data in Scleroderma Clinical Trials
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Scleroderma
Keywords: scleroderma
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2024-02-20
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with scleroderma who are actively considering participation in a clinical trial for this ailment, but have not yet concluded the enrollment and randomization phases.

Brief summary: Typically, specific demographic subsets tend to exhibit greater engagement in medical research. Nonetheless, there is insufficient research elucidating the trial characteristics influencing the participation of these particular demographics.

The study will analyze data from diverse demographic viewpoints to uncover recurring trends that could provide valuable insights for future patients with scleroderma.


Eligibility criteria: Inclusion Criteria:

* Patient has been diagnosed with scleroderma
* Patient has self-identified as planning to enroll in an observational clinical trial
* Patient is a minimum of 18 years or older

Exclusion Criteria:

* Patient is pregnant
* Inability to perform regular electronic reporting
* Patient does not understand, sign, and return consent form

Primary outcomes:
measure: Rate of patients in clinical research for scleroderma
timeFrame: 3 months
measure: Number of scleroderma study participants who stay committed until clinical study wraps up
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Power Life Sciences
state: California
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Careta MF, Leite Cda C, Cresta F, Albino J, Tsunami M, Romiti R. Prospective study to evaluate the clinical and radiological outcome of patients with scleroderma of the face. Autoimmun Rev. 2013 Sep;12(11):1064-9. doi: 10.1016/j.autrev.2013.05.005. Epub 2013 Jun 19.
citation: Harb S, Pelaez S, Carrier ME, Kwakkenbos L, Bartlett SJ, Hudson M, Mouthon L, Sauve M, Welling J, Shrier I, Thombs BD; SPIN Physical Activity Enhancement Patient Advisory Team and SPIN Investigators. Barriers and Facilitators to Physical Activity for People With Scleroderma: A Scleroderma Patient-Centered Intervention Network Cohort Study. Arthritis Care Res (Hoboken). 2022 Aug;74(8):1300-1310. doi: 10.1002/acr.24567. Epub 2022 May 11.
citation: Li SC. Treatment of juvenile localized scleroderma: current recommendations, response factors, and potential alternative treatments. Curr Opin Rheumatol. 2022 Sep 1;34(5):245-254. doi: 10.1097/BOR.0000000000000886.
Clinical trial NCT05045092: A Follow-up Study of Neonates Receiving Extracorporeal Life Support in China
Official title: A Follow-up Study of Neonates Receiving Extracorporeal Life Support in China
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Extracorporeal Life Support
Neurodevelopment
Neonate
Mortality
Extracorporeal Membrane Oxygenation
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: Chinese Neonatal Network
First posted: 2021-09-16
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates who receive ECLS support within 28 days of life and survive to the first discharge.

Brief summary: Descriptive study of two-year follow-up outcomes of surviving neonates who are enrolled in the Chinese Neonatal Extracorporeal Life Support Registry (Chi-NELS) from 2022 to 2024.

Detailed description: This study aims to describe the six -month, one-year and two-year neurodevelopmental outcomes of survivors of neonatal ECLS treatment in the Chi-NELS. The study population will be neonates who receive ECLS support within 28 days of life and are enrolled in the Chi-NELS. These infants will be prospectively followed for two years. Mortality, growth, and neurodevelopmental outcomes will be assessed at six months, one year and two years.

Eligibility criteria: Inclusion Criteria:

* Infants who receive extracorporeal life support (ECLS) at ≤28 days of life from 2022.1.1-2023.12.31
* Survive to the first ICU discharge

Exclusion Criteria:

* Infants who died during the ECLS hospitalization
* Parental refusal to follow-up

Primary outcomes:
measure: Mortality or severe/moderate neurodevelopmental delay at two-year old
timeFrame: At two-year old
Secondary outcomes:
measure: Body weight of infants at six months
timeFrame: At six months
measure: Length of infants at six months
timeFrame: At six months
measure: Head circumference of infants at six months
timeFrame: At six months
measure: Body weight of infants at one year old
timeFrame: At one year old
measure: Length of infants at one year old
timeFrame: At one year old
measure: Head circumference of infants at one year old
timeFrame: At one year old
measure: Body weight of infants at two years old
timeFrame: At two years old
measure: Length of infants at two years old
timeFrame: At two years old
measure: Head circumference of infants at two years old
timeFrame: At two years old
measure: Severe/moderate neurodevelopmental delay at six months
timeFrame: At six months
measure: Severe/moderate neurodevelopmental delay at one year old
timeFrame: At one year old
measure: Severe/moderate neurodevelopmental delay at two years old
timeFrame: At two years old
Other outcomes:
Locations:
Study officials:
affiliation: Children's Hospital of Fudan University, Shanghai, China
name: Yun Cao, Ph.D, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03321292: L-arginine in Treatment of Intrauterine Growth Restriction
Official title: Effect of L-Arginine on Intrauterine Growth Restriction Fetuses Measured by Birth Weight: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intrauterine Growth Restriction Asymmetrical
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-10-25
Enrollment: 260
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group(A) 130 pregnant women diagnosed with IUGR will receive L-arginine and Acetylesalicylic acid 75mg Group(B) 130 pregnant women diagnosed with IUGR will receive Acetylesalicylic acid 75mg
Primary purpose: TREATMENT

Brief summary: Intrauterine growth restriction is an important problem in neonatal care. Intrauterine growth restriction (IUGR) is defined as a fetal weight below the 10th percentile for gestational age. One of the main causes of IUGR is placental insufficiency.

Nitric oxide(NO) increases placental blood flow. So,it might be useful to improve IUGR pregnancy outcome .

Detailed description: The study population includes pregnant women attending Antenatal care clinic of Ain Shams University Maternity Hospital who first time diagnosed of IUGR at our antenatal care outpatient clinic either referred for this cause After confirm diagnosis of IUGR and distributing patient into two groups Patient in first group will receive oral L-arginine 3000mg/day till delivery and Acetylesalicylic acid 75mg once daily.

Patients in second group will receive Acetylesalicylic acid 75mg once daily. then follow up of both group by:

1. Daily fetal movement counting
2. Day after day CTG
3. Doppler twice weekly
4. Pelvic u/s weekly for:

A) Head circumference, Abdominal circumference, femur length B) Fetal weight C) Liquor amount: Amniotic Fluid Index Or MeanVertical Pocket

Decision of delivery will be determined when:

A) Fetal distress (non stress CTG) B) Mother starts labour C) Reversed umbilical artery Doppler.

Eligibility criteria: Inclusion Criteria:

* All pregnant women diagnosed with IUGR from 28 weeks
* Singleton pregnancy
* No maternal systemic disease
* No congenital fetal malformation
* Estimated fetal weight below 10th percentile

Exclusion Criteria:

* All pregnant woman diagnosed with IUGR before 28 weeks
* Multiple pregnancy
* Maternal systemic disease
* Congenital fetal malformation

Primary outcomes:
measure: Birth weight
timeFrame: 15 min
Secondary outcomes:
measure: Apgar score
timeFrame: at one and five minute after birth.
measure: Amniotic fluid index
timeFrame: evey one week from 28 weeks gestation till 40 weeks gestation
measure: Umbilical artery Doppler
timeFrame: every from 28 weeks gestation till 40 weeks gestation
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: Ain Shams University
name: Hayam FA Mohammad, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03863392: Oral Misoprostol Solution in Comparison to Vaginal Misoprostol in Induction of Labor
Official title: Oral Misoprostol Solution in Comparison to Vaginal Misoprostol in Induction of Labor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Normal Vaginal Delivery
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-03-05
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Induction of labour at term is a common obstetric intervention. Induction of labour is the artificial initiation of labour before its spontaneous onset for the purpose of delivery of the fetoplacental unit using mechanical or pharmacological methods.

To determine the effects of oral misoprostol solution compared to vaginal misoprostol in induction of labour.

Detailed description: Patients recruited in the study will be primigravida at term with obstetric or medical indication for labour induction. These patients will be either booked attending antenatal clinic referred for induction of labour or emergency admissions in labour room.

A total of 100 women will be randomly selected for the study. I. Women will be given 20 ml (20 µg) of misoprostol solution orally every 2 hourly until adequate uterine contractions occurred (3 contractions per 10 min lasting 30-40 s).

II. The induction regimen included application of Vagiprost 25 µg tablet in the posterior fornix of the vagina every 4 h (up to 6 doses) after determination of the Bishop score.

Eligibility criteria: Inclusion Criteria:

* Primigravida or Primipara
* Pregnancy between 36 and 42 weeks of gestation.
* A live singleton fetus in cephalic presentation.
* No history of uterine surgery.
* Clinically adequate pelvis.
* Modified Bishop's score \<5.
* Reactive Non stress test (NST) .

Exclusion Criteria:

* •Known hypersensitivity or contraindications to oral misoprostol (uterine surgery).

  * Any antenatal medical complications.
  * A situation requiring LSCS (Maternal or Fetal) e.g:fetal distress
  * Non-reactive NST.
  * Patient's refusal to give consent

Primary outcomes:
measure: •Induction-delivery time
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ainshams University
Study officials:
References: