louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02602106: Regular Aquatic Activities and Pregnancy Outcomes
Official title: Effects of Regular Aquatic Activities on Pregnancy Outcomes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Weight Gain
Keywords: Aquatic activities
Aerobic exercise
Resistance exercise
Pregnancy
Maternal weight gain
birthweight
Lead sponsor: Universidad Politecnica de Madrid
Sponsor class: OTHER
First posted: 2015-11-11
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Aquatic activities is one of the most attractive physical exercise during pregnancy, especially during the third trimester.

Detailed description: The aim of this study was to evaluate the effect of moderate regular aquatic exercise during pregnancy on maternal and fetus outcomes.

Eligibility criteria: Inclusion Criteria:

* Healthy pregnant women without any medical or obstetric complication to practice moderate exercise
* Being able to communicate in Spanish

Exclusion Criteria:

* Being interesting in the study after 16 weeks of gestation
* Having obstetric contraindications
* Not attended regular to the exercise program

Primary outcomes:
measure: Maternal gestational weight gain
timeFrame: 40-42 weeks
measure: Birthweight
timeFrame: 37-42 weeks
Secondary outcomes:
measure: Number of participants with adverse pregnancy outcomes as assessed by medical records
timeFrame: 37-42 weeks
measure: Gestational age
timeFrame: 37-42 weeks
measure: Maternal blood pressure and gestational diabetes as assessed by medical records
timeFrame: 9 to 42 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Thecnical University of Madrid
Study officials:
affiliation: Technical University of Madrid
name: Ruben Barakat Carballo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bacchi M, Mottola MF, Perales M, Refoyo I, Barakat R. Aquatic Activities During Pregnancy Prevent Excessive Maternal Weight Gain and Preserve Birth Weight: A Randomized Clinical Trial. Am J Health Promot. 2018 Mar;32(3):729-735. doi: 10.1177/0890117117697520. Epub 2017 Mar 9.
Clinical trial NCT04714606: Feasibility Controlled Trial of an 8-session Group Intervention for Siblings of Children Who Have ASD
Official title: Feasibility Controlled Trial of an 8-session Group Intervention for Siblings of Children Who Have ASD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: University of Surrey
Sponsor class: OTHER
First posted: 2021-01-19
Enrollment: 12
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A feasibility controlled trial of an eight-session group intervention for siblings of children who have an Autism Spectrum Disorder (ASD).

Children will be recruited from a multi-academy trust of nine schools. Due to the on-going impact of COVID-19 restrictions, children will be allocated to the intervention condition (eight session support group) if they are physically attending school and to the control condition (receipt of a booklet) if they remain at home. Pre and post outcome measures will be completed by children and their parents in both research arms.


Eligibility criteria: Inclusion Criteria:

1. 7-11 years old.
2. Must have a sibling who has a formal diagnosis of ASD.
3. Must be competent in the English language.
4. Must be in mainstream education.
5. Must be willing and able to engage in an eight-session group intervention (including being accompanied to and from the group by their parents/carers).
6. Must be registered with a GP and parental consent gained to inform the GP that the sibling is attending the group.

Exclusion Criteria:

1. If the sibling has a diagnosis of ASD themselves.
2. If there are any clear risk concerns (e.g. any thought or intent to harm self or others, involvement in court proceedings or with the criminal justice system).
3. If the sibling is currently receiving any other psychological treatment.
4. If the sibling has a learning disability or difficulty that will make it hard to access the group content and/or capacity to provide informed consent.

Primary outcomes:
measure: Change in Strengths & Difficulties Questionnaire (SDQ, Goodman et al., 2009) scores
timeFrame: Pre (Week 1) and post (Week 6) intervention
measure: Change in Paediatric Quality of Life Inventory (PedsQL V4.0; Varni, Seid & Kurtin, 2001) scores
timeFrame: Pre (Week 1) and post (Week 6) intervention
measure: Change in Knowledge of Autism Questionnaire (KAS; Ross & Cuskelly, 2006) scores
timeFrame: Pre (Week 1) and post (Week 6) intervention
measure: Change in Goal Based Outcomes (GBOs, Law & Jacob, 2015) scores Goal Based Outcomes (GBOs, Law & Jacob, 2015)
timeFrame: Pre (Week 1) and post (Week 6) intervention
Secondary outcomes:
measure: Experience of Service Questionnaire (ESQ, Attride-Stirling, 2002)
timeFrame: Post intervention (6 weeks after Time 1)
Other outcomes:
Locations:
city: Leatherhead
country: United Kingdom
facility: The Howard Partnership Multi-Academy Trust
Study officials:
affiliation: University of Surrey
name: Lucy Ms Watson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01855906: The Impact of Total Knee Arthroplasty Surgical Technique on Coronal Plane Motion and PatelloFemoral Articulation
Official title: The Impact of Total Knee Arthroplasty Surgical Technique on Coronal Plane Motion and PatelloFemoral Articulation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Osteoarthritis
Keywords: Total knee replacement
Gap balanced
Measured resection
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2013-05-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the impact of two surgical techniques on the outcome of the knee replacement surgery.

Detailed description: How stable a total knee replacement is depends on the correct and precise rotation of the femoral component. Abnormal femoral component rotation has been associated with numerous adverse conditions including knee instability, knee pain, scar tissue, and abnormal knee motion. Controversy exists, however, regarding the most favorable surgical technique to determine accurate femoral component rotation. Some doctors prefer a measured resection technique in which landmarks on the femur bone are used to determine where to place the femoral component. Others recommend a gap-balancing technique in which the femoral component is positioned by balancing the ligaments of the knee and placing it in the position where each ligament is equally strained.

The purpose of this study is to examine the impact of the measured resection and gap-balancing surgical technique on how the total knee replacement moves and patient knee outcome scores. Knee outcome scores are assessed from the responses given by patients to questions about outcomes associated with total knee replacement related to pain, symptoms, activities of daily living, sport and recreational function, and knee-related quality of life.

Eligibility criteria: Inclusion Criteria:

* Surgeon and patient have determined that patient requires a primary total knee arthroplasty and agrees to participate and signs the informed consent for study.

Exclusion Criteria:

* History of alcoholism
* Unable to speak English
* Inflammatory Arthritis
* Pregnant women or any woman with plans to begin a family.

Primary outcomes:
measure: The primary objective will be to assess coronal balance through a range of motion.
timeFrame: One year post-operatively
Secondary outcomes:
measure: Patellofemoral tracking
timeFrame: One year post-operatively
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: London Health Sciences Centre - University Hospital
name: Brent Lanting, MD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01831206: Collagen Cross-linking in Infectious Keratitis Trial
Official title: Collagen Cross-linking in Infectious Keratitis Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infectious Keratitis
Bacterial Keratitis
Fungal Keratitis
Keywords: corneal ulcer
keratitis
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2013-04-15
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of collagen cross-linking for treatment of infectious keratitis.


Eligibility criteria: Inclusion Criteria:

* Evidence of corneal ulcer grade II or III (bacteria or fungal, or presumed bacterial or fungal)
* Age more than 6 year
* Patients can understand and can follow the study protocol

Exclusion Criteria:

* Pregnancy by history or urine test
* Evidence of herpetic keratitis
* Evidence of corneal perforation
* Evidence of autoimmune disease
* Known allergy to study medication

Primary outcomes:
measure: decrement of infiltration size
timeFrame: 1 months
Secondary outcomes:
measure: number of participants with adverse events
timeFrame: 1 months
Other outcomes:
Locations:
city: Pratumwan
country: Thailand
facility: Ophthalmology department, King Chulalongkorn Memorial hospital
state: Bangkok
Study officials:
References:
citation: Davis SA, Bovelle R, Han G, Kwagyan J. Corneal collagen cross-linking for bacterial infectious keratitis. Cochrane Database Syst Rev. 2020 Jun 17;6(6):CD013001. doi: 10.1002/14651858.CD013001.pub2.
Clinical trial NCT06065306: Potential Diagnostic Biomarkers for Aortic Dissection in the Emergency Department
Official title: Potential Diagnostic Biomarkers for Aortic Dissection in the Emergency Department: the Aggrecan, Desmosine, D-dimer-Emergency Department (ADD-ED) Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Dissection
Keywords: aortic dissection
biomarker
diagnostic
d-dimer
aggrecan
desmosine
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2023-10-03
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 18 years or above, with AD presenting to the ED within the first 24 hours of symptom onset will be recruited.

Brief summary: The goal of this observational study is to determine the utility of desmosine, D-dimer and aggrecan as early diagnostic biomarkers in aortic dissection. The main questions it aims to answer are:

* To investigate the plasma levels of selected biomarkers in ED patients with confirmed aortic dissection
* To study the diagnostic performance of plasma levels of selected biomarkers for aortic dissection
* To study the association between plasma levels of selected biomarkers and clinical outcomes


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Presentation to the ED with first 24 hours of symptoms suggesting AD, including chest pain, upper back pain, syncope of unknown cause, symptoms of any acute perfusion deficit
* Confirmed AD

  * the diagnosis of AD adjudicated by an independent expert panel at hospital discharge or death, whichever comes first
  * The expert panel will consist of (1) a specialist in Emergency Medicine and (2) a specialist in Cardiology and (3) a specialist in Cardiothoracic Surgery.

Exclusion Criteria:

* Age \<18 years old
* Pregnancy
* Surgery or stenting performed before recruitment

Primary outcomes:
measure: Serum levels of D-Dimer, Aggrecan and Desmosine
timeFrame: Blood samples taken preoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Sha Tin
country: Hong Kong
facility: Prince of Wales Hospital
state: NT
Study officials:
References:
Clinical trial NCT04691206: Operative Curriculum Gallbladder Surgery
Official title: A Resident-initiated, Step-wise, Competency-based, Graduated Operative Curriculum to Enhance Resident Autonomy for Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Education
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-12-31
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The goal of this study is to implement and evaluate the need, feasibility and effectiveness of a resident-initiated, step-wise, graduated operative curriculum designed to enhance resident autonomy for laparoscopic cholecystectomy for general surgery residents.

Detailed description: The goal of this study is to improve resident autonomy and confidence through detailed and stepwise feedback and to also assess resident and attending perceptions regarding resident skill and autonomy.

Eligibility criteria: Inclusion Criteria:

* All Mayo Clinic general surgery residents and attendings across all campuses

Exclusion Criteria:

* None

Primary outcomes:
measure: Change in Surgical Resident's Autonomy
timeFrame: Baseline, postoperatively approximately one day
measure: Change is Surgical Resident's Operative Skills
timeFrame: Baseline, postoperatively approximately one day
measure: Change in Surgical Resident's Confidence
timeFrame: Baseline, postoperatively approximately one day
Secondary outcomes:
measure: Difference in Surgical Resident and Attending Physician Perceptions
timeFrame: Baseline, postoperatively approximately one day
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Sarah McLaughlin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01078506: Prevalence of Intracranial Aneurysm in Hong Kong Chinese
Official title: Prevalence of Intracranial Aneurysm in Hong Kong Chinese
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracranial Aneurysm
Keywords: Chinese
intracranial aneurysm
magnetic resonance imaging
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2010-03-02
Enrollment: 200
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hong Kong Chinese without a history of known intracranial pathologies

Brief summary: Intracranial aneurysm (localized dilatation in weakened blood vessel wall) rupture is a catastrophic disease, with half of the victims died and many of the survivors disabled. There is currently no data in the literature for the Chinese population concerning the prevalence, characteristics (location and size) and risk of harboring an unruptured intracranial aneurysm. In this study, the investigators aim to study the population prevalence and characteristics (location and size) of intracranial aneurysm in Hong Kong Chinese, and its cost-effectiveness. The screening is carried out using magnetic resonance angiography (MRA), with a 3-T magnetic resonance system, which is a well-established non-invasive method for intracranial aneurysm detection.

Detailed description: As charted below.

Eligibility criteria: Inclusion Criteria:

* Healthy adults aged between 21 and 65 years

Exclusion Criteria:

* Contraindications to MRI
* History of known intracranial pathologies

Primary outcomes:
measure: Intracranial aneurysm
timeFrame: Three years
Secondary outcomes:
measure: Other intracranial pathologies
timeFrame: Three years
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Department of Surgery, The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: George KC Wong
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05612906: Renal Nerve Denervation(RDN) and Renal Function
Official title: Effect of RDN on Renal Function
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Effects of RDN on Renal Function
Lead sponsor: The First Affiliated Hospital of Xiamen University
Sponsor class: OTHER
First posted: 2022-11-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with refractory hypertension

Brief summary: Current studies have found the efficacy of RDN in the treatment of hypertension, however, the safety of RDN in renal function is still lacking. Therefore, the investigators are aimed to study the effect of RDN on renal function.


Eligibility criteria: Inclusion Criteria:

1.18\<age≤75 years; 2.clinic blood pressure ≥ 140/90 mmHg or 24-hour ambulatory blood pressure monitoring average blood pressure ≥ 135/85 mmHg after taking 3 or more antihypertensive drugs for more than 4 weeks; 3.essential hypertension, renal parenchymal hypertension, or hypertension patients who are willing to receive RDN ; 4.who signed informed consent and were approved by the Ethics Committee of the First Affiliated Hospital of Xiamen University.

Exclusion Criteria:

* pregnant women or lactating patients;

  * identified secondary hypertension or Pseudo hypertension;

    * whose renal arteries were unsuitable for ablation

      * obvious bleeding tendency and blood system diseases;

        * malignant tumors or end-stage diseases; ⑥Severe peripheral vascular disease, abdominal aortic aneurysm; ⑦A history of the acute coronary syndrome within two weeks; ⑧acute or severe systemic infection; ⑨drug or alcohol dependence or refusal to sign informed consent.

Primary outcomes:
measure: Changes of serum creatinine and urea nitrogen before and after RDN operation
timeFrame: Baseline,1week/1 month/6months after RDN operation
measure: Changes of glomerular filtration rate before and after RDN operation
timeFrame: Baseline, 6months after RDN operation
Secondary outcomes:
measure: Effect of RDN operation on renal artery
timeFrame: Baseline, 6months after RDN operation
measure: Urinary protein/serum creatinine ratio change before and after RDN operation
timeFrame: Baseline,1week/1 month/6months after RDN operation
Other outcomes:
Locations:
city: Xiamen
country: China
facility: zhengrong Huang
state: Fujian
Study officials:
References:
Clinical trial NCT04938206: DIStinguishing ChildrEn at Low Risk of Severe infectioN in Case of Febrile Neutropenia-7: Impact Study of a Clinical Decision Rule
Official title: DIStinguishing ChildrEn at Low Risk of Severe infectioN in Case of Febrile Neutropenia-7: Impact Study of a Clinical Decision Rule
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neutropenia, Febrile
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2021-06-24
Enrollment: 1480
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Febrile neutropenia (NF) is the leading cause of unscheduled hospitalization in children with cancer. Management classically involves emergency admission to hospital for intravenous antibiotic treatment until resolution of fever and neutropenia. However, children with NF are a heterogeneous group with varying risks of severe infection (10-29%). This approach, which is recognized as excessive for low-risk episodes of severe infection, particularly in terms of quality of life and cost, is no longer recommended. Management should move to a more personalized model that takes into account the individual probability of severe infection. Clinical decision rules (CDRs) have been proposed to facilitate risk stratification, but none are useful in our French population because of insufficient reproducibility or effectiveness.


Eligibility criteria: Inclusion Criteria:

* Followed for hemopathy or cancer,
* Presenting with post-chemotherapy NF,
* With social security coverage,
* With parents able to provide appropriate home supervision,
* Consent of parents and child if able to give consent.

Exclusion Criteria:

* NF to diagnosis of tumor disease,
* Child with palliative care,
* Child who has had an allogeneic hematopoietic stem cell transplant within the past year,
* NF immediately following an autologous hematopoietic stem cell transplant,
* Participation in the study during a previous NF,
* Curative antibiotic therapy or documented infection prior to admission,
* Initial management at a non-investigative center,
* Refusal of the child or parents to participate

Translated with www.DeepL.com/Translator (free version)

Primary outcomes:
measure: Change in quality of life score, calculated from the PedsQL™ scale between inclusion and Day 6.
timeFrame: at day 6
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Jeanne de Flandre Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: François Dubos, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: