louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06572787: Family Centered Services in Cerebral Palsy
Official title: Evaluation of Family Centered Service in the Physiotherapy and Rehabilitation Processes of Children with Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Keywords: Physiotherapy
Rehabilitation
Family Centered Services
Impact Family
Cerebral Palsy
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-08-27
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children diagnosed with cerebral palsy between the ages of 2 and 18 who have received physiotherapy and rehabilitation services for at least one year and their parents

Brief summary: To examine the family-centered service characteristics of physiotherapy and rehabilitation services received by children with cerebral palsy (CP) and to investigate the affecting factors.

Detailed description: Children with Cerebral Palsy (CP) attend special education and rehabilitation centers to receive physiotherapy and rehabilitation (PT) services, and it is very important for parents to be informed about the services offered in these centers. Our aim in the study was to examine which factors affect family-centered characteristics and parental perceptions in the PT services received by children with CP. For this purpose, 100 children diagnosed with CP between the ages of 2-18 and their parents were included in the study. The Measure of Processes Care (MPOC) survey was used to assess parents' perceptions of the family-centered features of (PT) services. These perceptions were examined to determine whether they vary depending on the child's age, functional level, parents' educational status, the impact of their disabled children, and health-related quality of life. The Family Impact Scale was used to measure parents' level of influence from their disabled children, and the Nottingham Health Profile survey was used to evaluate their health-related quality of life.

Eligibility criteria: Inclusion Criteria:

* Having a child aged between 2 and 18 years diagnosed with cerebral palsy
* Receiving physiotherapy and rehabilitation services for at least one year
* The family's consent to participate in the study and their approval for their child to be assessed by the researcher physiotherapist and for their information to be collected within the scope of the study

Exclusion Criteria:

* Parents over the age of 65
* Parents who do not speak Turkish
* Having another child with a disability

Primary outcomes:
measure: Measure of Processus of Care
timeFrame: 3 months
Secondary outcomes:
measure: Impact on Family Scale
timeFrame: 3 months
measure: Nottingham Health Profile
timeFrame: 3 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe Universty
state: Sıhhiye
Study officials:
affiliation: Hacettepe University
name: Mustafa Öcalan, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05697887: Feasibility, Tolerability and Efficacy of the Ketogenic Diet in Children With Drug-resistant Epilepsy in South Vietnam
Official title: Feasibility, Tolerability and Efficacy of the Ketogenic Diet in Children With Drug-resistant Epilepsy in South Vietnam
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Resistant Epilepsy
Ketogenic Diet
Feasibility
Tolerability
Efficacy
Children
Keywords: drug resistant epilepsy
ketogenic diet
Lead sponsor: Number 2 Children's Hospital, Ho Chi Minh City
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 45
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Children with drug-resistant epilepsy followed at Children's Hospital No.2, Viet Nam treated by KD were included in a prospective study from June 2019 to October 2021. Side-effects, retention rate, number, and duration of seizures were recorded after 1, 3, 6, 9 and 12 months of KD. Patients were considered as responder when a 50% seizure frequency was reached. Tolerance and acceptability of the KD were closely monitored.
Primary purpose: TREATMENT

Brief summary: According to the World Health Organization, more than 50 million people have epilepsy. Among them, nearly 80% of epileptic patients live in developing countries and 75% of them do not have access to treatment. The ketogenic diet (KD) has been shown as an effective alternative for patients with drug-resistant epilepsy. Although it has been studied by few studies in Asia, no such studies have been conducted in Vietnam. The purpose of this study was to verify the feasibility, tolerability, and efficacy of the KD in children with refractory epilepsies followed at a pediatric center in South Vietnam.

Detailed description: Children with drug-resistant epilepsy followed at Children's Hospital No.2, Viet Nam treated by KD were included in a prospective study from June 2019 to October 2021. Side-effects, retention rate, number, and duration of seizures were recorded after 1, 3, 6, 9, and 12 months of KD. Patients were considered as responders when a 50% seizure frequency was reached. Tolerance and acceptability of the KD were closely monitored.

Eligibility criteria: Inclusion Criteria:

* age from 1 to 10 years at the time of enrolment,
* drug-resistant epilepsy according to the 2010 ILAE criteria,
* an indication for a ketogenic diet trial according to the 2018 ILAE recommendations

Exclusion Criteria:

- clinical or laboratory features suggesting an underlying disease contra-indication the use of a ketogenic diet

Primary outcomes:
measure: The feasibility of the ketogenic diet
timeFrame: 12 months
measure: The tolerability of the ketogenic diet at 12 months
timeFrame: 12 months
measure: The efficacy of the ketogenic diet at 12 months
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ho Chi Minh city
country: Vietnam
facility: N02 Children's Hospital
state: Ho Chi Minh
Study officials:
References:
Clinical trial NCT02887287: Efficacy of Exclusive Enteral Nutrition in Adult Active Crohn's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Efficacy of Exclusive Enteral Nutrition in Adult Active Crohn's Disease With Complications or Failure of Medical Treatment
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-09-02
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The detailed inclusion criteria included: 1. \>18 years old 2. Patients with CD was diagnosed clinically according to previously established international criteria \[9\] 3. The diagnosis of stricture, fistula and abdominal abscess was confirmed by ultrasound, CT enterography (CTE), and endoscopy. The bowel stricture should mainly cause by inflammation but not fibrosis. Intolerance or failure to steroids or IFX was judged by medical history 4. The disease was in an active period.

Brief summary: The study aimed to prove EEN is effective for inducing early clinical remission, mucosal healing, promoting fistula closure and reducing the size of abscess to adult CD patients. They plan to include about 50 patients and observe the effect of EEN.


Eligibility criteria: Inclusion Criteria:

* \>18 years old
* Patients with CD was diagnosed clinically according to previously established international criteria \[9\]
* The diagnosis of stricture, fistula and abdominal abscess was confirmed by ultrasound, CT enterography (CTE), and endoscopy. The bowel stricture should mainly cause by inflammation but not fibrosis.

Exclusion Criteria:

* Patients do not macth the inclusion criteria and those who refuse to taking part in the study

Primary outcomes:
measure: Clinical remission after 12 weeks EEN
timeFrame: July 2013 to October 2015
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The six affiliated hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References:
citation: Yang Q, Gao X, Chen H, Li M, Wu X, Zhi M, Lan P, Hu P. Efficacy of exclusive enteral nutrition in complicated Crohn's disease. Scand J Gastroenterol. 2017 Sep;52(9):995-1001. doi: 10.1080/00365521.2017.1335770. Epub 2017 Jun 9.
Clinical trial NCT03751787: Cranial Osteopathy in Functional Disorders of the Newborn
Official title: Interest of Treatment With Cranial Osteopathy in Functional Disorders of the Newborn
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Newborn Complication
Keywords: osteopathy
cranial
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2018-11-23
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 29
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate, from the maternity stay, the interest of the cranial osteopathy in the reduction of the hyper irritability of the newborn and the improvement of the postural abnormalities


Eligibility criteria: Inclusion Criteria:

* Newborns:

  * forward
  * born vaginally or cesarean section
  * with or without general anesthesia
  * with or without epidural or spinal anesthesia
  * with or without instrumental extraction
  * presenting at least 1 of the 4 criteria detailed above, numbered at 3 or 4 or two criteria at 2

Exclusion Criteria:

* Newborns presenting:

  * a score of Amiel \<7, signing a strong suspicion of non-integrity of brain functions (see table) and therefore leaving the framework of functional pathology
  * symptomatic maternal-fetal infection
  * true obstetric trauma: brachial plexus paralysis, fracture
  * or of a mother who has taken during pregnancy drugs or toxic drugs that affect the behavior of the newborn. (benzodiazepines, subutex, methadone, cocaine, heroin or cannabis)

Primary outcomes:
measure: Reduction of hyper irritability
timeFrame: at 28 days of life.
Secondary outcomes:
measure: Reduction of hyper irritability
timeFrame: before any treatment, at 3 days after deliverance and at 28 days of life
Other outcomes:
Locations:
city: Roubaix
country: France
facility: Maternité Paul Gelé du CH de Roubaix
Study officials:
affiliation: University Hospital, Lille
name: Eric Boez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03935087: Improvement of Left Ventricular Ejection Fraction in ICD Patients Undergoing Therapy With Sacubitril/Valsartan
Official title: Improvement of Left Ventricular Ejection Fraction in ICD Patients Undergoing Therapy With Sacubitril/Valsartan and Potential Impact on ICD Implant Rates for Primary Prevention of Sudden Cardiac Death (SAVE-ICD)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Lead sponsor: Azienda Ospedaliera Cardinale G. Panico
Sponsor class: OTHER
First posted: 2019-05-02
Enrollment: 150
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: Patients with heart failure, left ventricular systolic dysfunction, carrying a single-chamber or a bicameral implantable cardioverter defibrillator implanted for primary prevention of sudden death, and undergoing therapy with Sacubitril/Valsartan according to current Guidelines

Brief summary: The study is aimed to evaluate the improvement of the left ventricular volumes and of the left ventricular ejection fraction in a population of ICD patients with heart failure and left ventricle systolic dysfunction undergoing therapy with Sacubitril/Valsartan (according to current Guidelines), during a 6-month follow-up.

Detailed description: Consecutive, unselected patients with heart failure and left ventricle systolic dysfunction, carrying a single-chamber or a bicameral implantable cardioverter defibrillator (ICD) for primary prevention of sudden death, undergoing therapy with Sacubitril/Valsartan (according to current Guidelines) will be enrolled in the study. A two-dimensional echocardiogram with evaluation of left ventricular end-diastolic volume, left ventricular end-systolic volume, and left ventricular ejection fraction will be performed, according to standard clinical practice, at the beginning of the observation, and at a 6-month follow-up. The improvement of the left ventricle volumes and of the left ventricular ejection fraction will be evaluated.

Eligibility criteria: Inclusion Criteria:

* heart failure
* left ventricular systolic dysfunction
* carrying a single-chamber or a bicameral implantable cardioverter defibrillator implanted for primary prevention of sudden death
* undergoing therapy with Sacubitril/Valsartan according to current Guidelines

Exclusion Criteria:

* age \<18 years

Primary outcomes:
measure: Improvement in left ventricular ejection fraction
timeFrame: at enrollment and at 6 months of follow-up
Secondary outcomes:
measure: Reduction in left ventricle volumes
timeFrame: at enrollment and at 6 months of follow-up
Other outcomes:
Locations:
city: Tricase
country: Italy
facility: "Card. G. Panico" Hospital
state: Lecce
city: Ancona
country: Italy
facility: Federico Guerra
city: Bologna
country: Italy
facility: Policlinico S.Orsola-Malpighi
city: Catanzaro
country: Italy
facility: AO Pugliese-Ciaccio
city: Napoli
country: Italy
facility: Monaldi Hospital
city: Novara
country: Italy
facility: AOU "Maggiore della Carità"
Study officials:
References:
Clinical trial NCT01776333: A Randomized Controlled Trial of a Video Decision Aid in the ICU
Official title: Video Images of Disease for Ethical Outcomes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Failure
Cardiac Event
Keywords: ICU
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2013-01-28
Enrollment: 150
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Randomized Controlled Trial of a Video Decision Aid in the ICU in surrogates of admitted patients.


Eligibility criteria: Inclusion Criteria:

- Age 65 or older Patient does not have the capacity to make decisions Patient admitted to the ICU with life threatening illness including advanced heart, renal, lung, gastrointestinal and oncologic disease Patient has English speaking representative to make decisions on his/her behalf Patient critically ill and unlikely to survive to hospital discharge

Exclusion Criteria:

- Patients who are imminently dying and admitted to the ICU are excluded Wards if the state

Primary outcomes:
measure: preference for goal of care regarding medical interventions (e.g., CPR, intubation, etc.)
timeFrame: at baseline admission to the ICU during family meeting up to one week
Secondary outcomes:
measure: level of medical care delivered to patient at time of death or discharge from the ICU
timeFrame: at time of death or discharge from the ICU up to one week
measure: anxiety and depression
timeFrame: anxiety and depression at follow up phone call at 3 months after ICU death or discharge
measure: satisfaction with ICU experience
timeFrame: after 3 months from time of death or discharge from ICU
measure: number of medical interventions during ICU stay
timeFrame: during time period in the ICU up to one week
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Boston
country: United States
facility: BMC
state: Massachusetts
city: Boston
country: United States
facility: MGH
state: Massachusetts
Study officials:
affiliation: MGH
name: Angelo Volandes
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02179333: Preliminary Study of the Scale To Assess Ataxia and Neurologic Dysfunction (STAND)
Official title: Preliminary Study of the Scale To Assess Ataxia and Neurologic Dysfunction (STAND)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinocerebellar Ataxia - All Sub-types
Friedreich's Ataxia
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2014-07-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community members, support group members or clinic patients with ataxia.

Brief summary: The objectives of this study are:

* To validate the inter-rater and intra-rater reliability of a new scale for the assessment of ataxia and neurologic dysfunction (STAND)
* To assess common constructs and correlation between STAND subscale items.

Detailed description: There are few validated, comprehensive rating scales for the assessment of ataxia severity. The development of a Scale To assess Ataxia and Neurologic Dysfunction (STAND) would examine and measure as many facets of ataxia as possible. Scale items to be measured include parkinsonism, timed gait analysis, dystonia, neuropathy and peripheral nerve weakness, as well as other areas of clinical manifestation for ataxia. This brief but thorough scale should yield a thorough measurement of ataxia.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of ataxia.
* Male or female between 18 and 80 years of age.
* Subject has voluntarily signed an IRB approved informed consent form to participate in the study after all relevant aspects of the study have been explained and discussed with the subject.

Exclusion Criteria:

* Any illness that in the investigator's opinion preclude participation in this study.
* Subjects with a cardiac pacemaker
* Legal incapacity or limited legal capacity.

Primary outcomes:
measure: Inter- and intra-rater agreement
timeFrame: 4 to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
Study officials:
References:
Clinical trial NCT04819633: Evaluating Serum Sestrin in Leiomyoma Patients
Official title: Evaluation of Serum Sestrin Levels in Patients With Leiomyoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uterine Leiomyoma
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-03-29
Enrollment: 61
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 30 patients diagnosed with uterine leiomyomas within the above mentioned age group (reproductive ages) are included in the study group. 30 age matched healthy subjects are included in the control group.

Brief summary: Leiomyomas are the most common benign neoplasms of women's reproductive system affecting 20-30% of women within the reproductive ages. Sestrins are serum proteins which are highly expressed under circumstances of DNA damage, hypoxia and oxditive stress and play an important role in autophagia. The aim of this study is to evaluate the relationship of serum sestrin proteins with development of leiomyomas.

Detailed description: Leiomyomas are the benign neoplasms of uterus and the role of genetics, estrogen levels and obesity has already been shown in their development. Higher levels of serum sestrin proteins have already been associated with DNA damage, hypoxia and oxidative stress and sestrin plays an important role in autophagia. In order to evaluate the role of serum sestrin in the development of leiomyomas 30 patients between 18-45 years of age who were diagnosed with uterine leiomyomas with transvaginal ultrasonography will be included in the study group. Their serum sestrin levels will be determined and compared with that of 30 healthy subjects recruited during the same study period at the same clinic.

Eligibility criteria: Inclusion Criteria:

* 18-45 years of age
* patients diagnosed with uterine leiomyomas will be included in the study group
* patients without any additional comorbidities
* patients without any autoimmune diseases

Exclusion Criteria:

* patients with systemic diseases
* patients with known chronic inflammatory diseases
* patients using hormonal and/or medical therapy
* pregnant women
* lactating women
* patients with malignant diseases

Primary outcomes:
measure: Evaluating the role of autophagia in the development of leiomyomas by evaluating the serum sestrin levels.
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sisli Hamidiye Etfal Training and Research Hospital
Study officials:
affiliation: University of Health Sciences Turkey, Istanbul Kanuni Sultan Suleyman Training and Research Hospital
name: Pinar Yalcin Bahat, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01418833: Preliminary Experience of Routine Voriconazole Therapeutic Drug Monitoring (TDM) in a Tertiary Care Centre
Official title: Preliminary Experience of Routine Voriconazole Therapeutic Drug Monitoring (TDM) in a Tertiary Care Centre.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients Treated With Voriconazole
Keywords: voriconazole
therapeutic drug monitoring
plasma levels
dose adjustment
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2011-08-17
Enrollment: 160
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with voriconazole, in whom at least 1 voriconazole plasma level was determined

Brief summary: The first goal of this study is to map all the subtherapeutic, therapeutic and supratherapeutic voriconazole plasma levels in the University Hospitals Leuven. The second objective is to optimize and validate guidelines for dose modifications in patients with too low or high plasma concentrations and to investigate if the same guidelines can be used in different patient populations.


Eligibility criteria: Inclusion Criteria:

* Patients treated with voriconazole
* at least 1 voriconazole plasma level measured during therapy

Exclusion Criteria:

* none

Primary outcomes:
measure: Voriconazole plasma levels during routine intravenous and oral therapy
timeFrame: trough levels every 4 days after start or dose adjustment of voriconazole
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
state: Vlaams-Brabant
Study officials:
affiliation: Catholic University of Leuven, Faculty of Pharmacy, division Hospital Pharmacy
name: Kim Vanstraelen, R.Ph.
role: PRINCIPAL_INVESTIGATOR
References: