louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05983887: The Effect of Therapeutic Climbing on Muscle Strength, Tone and Balance in Hemiplegic Children
Official title: The Effect of Therapeutic Climbing on Muscle Strength, Tone and Balance in Hemiplegic Children: a Preliminary Single-blind Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiplegia and Hemiparesis
Keywords: therapeutic climbing
hemiplegia
children
muscle strength
balance
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2023-08-09
Enrollment: 12
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blind Randomised Controlled Trial
Primary purpose: TREATMENT

Brief summary: The goal of this randomised controlled trial is to learn about the effect of therapeutic climbing in hemiplegic children. The main questions it aims to answer are:

Does climbing affect muscle strength and tone? What is its connection between normative data drawn from healthy children? How can it affect balance?

Participants (children) will be asked to complete an series of movements used in sports climbing, such as inside-flag, back-flag and horizontal traverse, while hanging on an in-door climbing wall.


Eligibility criteria: Inclusion Criteria:

* Children from 4 to 16 years old
* Children with Hemiplegia
* Evaluated as Level 1 on GMFCS

Exclusion Criteria:

* Botulinum toxin injection in last 6 months
* Surgery in the last 1 year (myofascial lengthening etc.)
* Children with poor cognitive skills (not following instructions etc.)

Primary outcomes:
measure: Muscle Strength
timeFrame: 8 weeks (pre-post evaluation)
measure: Balance
timeFrame: 8 weeks (pre-post evaluation)
measure: Muscle Tone
timeFrame: 8 weeks (pre-post evaluation)
Secondary outcomes:
measure: Normative Strength Data Comparison
timeFrame: 8 weeks (pre-post evaluation)
Other outcomes:
Locations:
city: Lamía
country: Greece
facility: Department of Physiotherapy
state: Phthiotis
Study officials:
affiliation: University of Thessaly
name: Thomas Besios, PhD
role: STUDY_CHAIR
References:
citation: Buechter RB, Fechtelpeter D. Climbing for preventing and treating health problems: a systematic review of randomized controlled trials. Ger Med Sci. 2011;9:Doc19. doi: 10.3205/000142. Epub 2011 Aug 9.
Clinical trial NCT02963987: Effect of Portion Size Over 5 Days in Preschool Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Feeding Behavior
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: United States Department of Agriculture (USDA)
First posted: 2016-11-15
Enrollment: 50
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: In this study, the investigators varied the portion size of all meals served during two 5-day periods. During one period, baseline amounts of all foods and beverages were served, and during the other, the portion size of all items was increased by 50%. The primary aim of the study is to determine the effect of varying the portion size of foods and beverages served over 5 days on energy intake in preschool children.


Eligibility criteria: Inclusion Criteria:

* Attending one of the designated childcare centers

Exclusion Criteria:

* Food Allergies
* Food Restrictions
* Health Issues that Preclude Participation
* Not available for duration of the study

Primary outcomes:
measure: Differences in Food and Beverage Intake by Energy
timeFrame: Days 1-5 in Periods 1 and 2
Secondary outcomes:
measure: Differences in Food and Beverage Intake by Energy Density
timeFrame: Days 1-5 in Periods 1 and 2
measure: Differences in Food and Beverage Intake by Weight
timeFrame: Days 1-5 in Periods 1 and 2
Other outcomes:
Locations:
city: University Park
country: United States
facility: Laboratory for the Study of Human Ingestive Behavior
state: Pennsylvania
city: University Park
country: United States
facility: The Pennsylvania State University, Laboratory for the Study of Human Ingestive Behavior
state: Pennsylvania
Study officials:
References:
citation: Smethers AD, Roe LS, Sanchez CE, Zuraikat FM, Keller KL, Kling SMR, Rolls BJ. Portion size has sustained effects over 5 days in preschool children: a randomized trial. Am J Clin Nutr. 2019 May 1;109(5):1361-1372. doi: 10.1093/ajcn/nqy383.
Clinical trial NCT05311787: The Strategy of Implementation of the ERAS Protocol After Esophageal Surgery
Official title: The Strategy of Implementation of the ERAS Protocol After Esophageal Surgery Based on Innovative Technologies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ERAS
Esophageal Diseases
Lead sponsor: Vishnevsky Center of Surgery
Sponsor class: OTHER
First posted: 2022-04-05
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All the patients over 18 years old with esophageal diseases who are required surgical treatment include in trial.
Primary purpose: TREATMENT

Brief summary: Application of the perioperative enhanced recovery protocol has allowed to carry out esophagectomy to the patients with severe comorbidities and has led reducing the risks of severe postoperative complications.

Detailed description: The clinical trial included the parients who participated in the protocol ERAS since 2011, who uderwent esophagectomy with simultaneous reconstruction. The parients had benign or malignant esophageal diseases. The ERAS protocol consisted of components of perioperative recovery. The number of patients until now has reached 400 patients. During trial there was modifications of aspects of ERAS protocol such as a rejection of nasogastric tube or cervical drenage. The role of multidisplinary team is the main success of the result of the implemented ERAS protocol.

Eligibility criteria: Inclusion Criteria:

* all patients with esophageal diseases

Exclusion Criteria:

* before 18 years old
* who do not need surgery as a treatment
* who not underwent simultaneous recontruction

Primary outcomes:
measure: mortality
timeFrame: 30 days
measure: morbidity
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Mary Yan
city: Moscow
country: Russian Federation
facility: Mary Yan
Study officials:
References:
Clinical trial NCT03838887: Comparison Between Uterine Artery Doppler and Placental Vascular Indices in Prediction of Preeclampsia
Official title: Comparison Between Uterine Artery Doppler and Placental Vascular Indices in Prediction of Preeclampsia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pre-Eclampsia
Lead sponsor: National Research Centre, Egypt
Sponsor class: OTHER
First posted: 2019-02-12
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All pregnant women will be examined for antenatal care in the outpatient clinic and fetal medicine unit of obstetrics and gynecology department then they will be divided into two groups control and high risk

Brief summary: • Preeclampsia is a multisystem disorder that can cause considerable maternal and fetal morbidity and mortality. Late preeclampsia (with delivery \>34 weeks) is more frequent and less serious than early preeclampsia (with delivery \<34 weeks). Poor early placentation has been especially associated with early disease. Early identification of women at risk of preeclampsia is currently a crucial aim of antenatal care since they may benefit from prophylactic treatment and increased surveillance.

Detailed description: * The introduction of three-dimensional (3D) ultrasound techniques, with the option of calculating placental volume and measuring vascular indices, has created an excellent opportunity to study early changes in the uteroplacental circulation space, which includes the maternal spiral arteries and the intervillous space. This technology may allow a more direct evaluation of the abnormal placentation process thought to herald the development of preeclampsia.
* The aim of this study was to assess the usefulness of placental volume and 3D vascular indices as reliable predictors of early preeclampsia in comparison to uterine artery Doppler

Eligibility criteria: Inclusion Criteria:

* A. Control group: Pregnant women:

  1. Age between 18-35 years
  2. Parity: primigravidas and multiparas.
  3. Have no history of preeclampsia or eclampsia.
  4. Have no history of chronic hypertension.
  5. Not diabetic.
  6. Not have antiphospholipid syndrome.
  7. Not have autoimmune disease such as SLE.

B. High risk group: Pregnant women with:

1. History of preeclampsia -Eclapmsia
2. Chronic hypertension
3. Diabetic
4. Antiphospholipid syndrome.
5. Autoimmune syndrome such as SLE.

Exclusion Criteria:

* • Smoking

  * Dichorionic placentae
  * Fetal anomaly
  * Uterine fibroid at the site of placental implantation
  * Subchorionic hematoma

Primary outcomes:
measure: placental vascular indices in prediction of preeclampsia
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Research Centre
Study officials:
References:
Clinical trial NCT06867887: Non-invasive Detection of Driveline Infections in Patients with a Left Ventricular Assist Device
Official title: Non-invasive Detection of Driveline Infections in Patients with a Left Ventricular Assist Device
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: LVAD (Left Ventricular Assist Device) Driveline Infection
Keywords: Infection
LVAD
Detection
Monitoring
Driveline infection
Imaging
Non-invasive
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Eindhoven University of Technology
First posted: 2025-03-10
Enrollment: 70
Sex: ALL
Minimum age (years): 16
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients implanted with an LVAD

Brief summary: The aim of this single center observational study is to determine the feasibility of using non-invasive imaging methods, including smartphone photography and infrared thermography, for detecting of DLIs in LVAD patients in terms of severity, extent and natural healing process.

Detailed description: Observational data of the driveline exit of LVAD patients will be collected during a follow-up period of 26 weeks. Two non-invasive imaging methods will be used.

Smartphone photos will be taken weekly by the patient during routine wound care in the home environment.

In case the patient is admitted for driveline infection, infrared thermographic (IRT) photography will be used to make thermographic photos of the driveline exit and the abdominal area of the subcutaneous driveline.

Furthermore, existing smartphone images and diagnostic data regarding prior DLI status will be obtained from the electronic patient records.

Imaging data will additionally be retrospectively analyzed using artificial intelligence (AI) and machine learning for the development of a predictive AI model.

Eligibility criteria: Inclusion Criteria: Patients age 16 years or older, implanted with an LVAD, followed at Erasmus MC, with access to a smartphone with a built-in camera, who have signed an informed consent for data collection.

Exclusion Criteria: Known cognitive problems, like dementia etc., non-cardiac disease or cardiac diseases resulting in a life expectancy less than 1 years, inability to read or sign the informed consent form.

Primary outcomes:
measure: Extent and severity of driveline infections in LVAD patients using non-invasive imaging
timeFrame: 26 weeks
measure: Driveline exit healing process and risk of infection of the LVAD driveline
timeFrame: 26
Secondary outcomes:
measure: Sceptic complications
timeFrame: 26 weeks
measure: Machine learning model for predicting DLIs.
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC
Study officials:
affiliation: Erasmus Medical Center
name: K. Caliskan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01340287: Effect of the Consumption of a Fermented Milk Enriched With Plant Sterols
Official title: Effects of the Consumption of a Plant Sterols-enriched Dairy Fermented Product on Hypercholesterolemia Management in Hypercholesterolemic Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Keywords: Plant sterol
Hypercholesterolemia
diet
dairy
isoprostanes
Midly hypercholesterolemic subjects
Lead sponsor: Danone Global Research & Innovation Center
Sponsor class: INDUSTRY
First posted: 2011-04-22
Enrollment: 168
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate the cholesterol lowering effect of a drinkable low fat fermented milk enriched with plant sterol after 3 and 6 weeks of daily consumption in midly hypercholesterolemic people not treated by statins.


Eligibility criteria: Inclusion Criteria:

* male/female subject,
* aged from 21 to 75 years,
* BMI between 19 and 30 kg/m2,
* LDL-cholesterol plasma level between 130 and 190 mg/dL without statin monotherapy,
* stabilized hypercholesterolemia,
* accepting to follow the dietary recommendations advisable for hypercholesterolemic patient (NCEP-ATP III guidelines),
* used to consume dairy products,
* effective contraceptive methods used for female subjects,
* having given written consent to take part in the study

Exclusion Criteria:

* subject with plasma triglycerides (TG) levels ≥ 350 mg/dL,
* having experienced any cardiovascular event in the last 6 months,
* taking any hypocholesterolemic treatment,
* diabetic subject (type I and type II),
* smoking strictly more than 10 cigarettes / day,
* heavy alcohol intake (\> 40 g / day for men ; \> 30 g / day for women),
* presenting known allergy or hypersensitivity to milk proteins,
* known soy allergy,
* refusing to stop the consumption of plant sterols-enriched products (other than the studied product),
* receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters,
* receiving a transplant and under immunosuppressor treatment,
* currently involved in a clinical trial or in an exclusion period following participation in another clinical trial,
* in a situation which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject,
* with any kind of disease likely to interfere with the evaluation of efficiency or safety of the product,
* for female subject: pregnancy, breast feeding or intention to be pregnant during the study or subject likely to change her contraceptive method during the study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
Study officials:
References:
Clinical trial NCT03647787: White Matter Integrity According to BDNF Genotype After Stroke
Official title: Changes of White Matter Integrity According to BDNF Genotype During Motor Recovery After Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2018-08-27
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ischemic stroke who were admitted to Samsung Medical Center and transferred to the Department of Physical and Rehabilitation Medicine

Brief summary: The aim of this study was to investigate differential plastic changes of fractional anisotropy (FA) in the corticospinal tract (CST), the intrahemispheric corticocortical tract from the primary motor cortex to ventral premotor cortex (M1PMv) and the corpus callosum (CC) from 2 weeks to 3 months after stroke according to BDNF genotype.

Detailed description: The aims of this study were to investigate plastic changes in the fractional anisotropy (FA) of three motor-related white matter fibers according to the BDNF genotype from 2 weeks to 3 months after stroke onset; one is a the majority of fibers from M1 to medullary oblongata (CST), another is the intrahemispheric connection from M1 to ventral premotor cortex (M1PMv), and the other is the interhemispheric connection between bilateral M1s (CC). There were also to investigate the relationships between motor impairment and tract-related FA of white matter tracts in each BDNF genotype

Eligibility criteria: Inclusion Criteria:

* diagnosed with first-ever hemispheric ischemic infarction with damage to the supratentorial area confirmed by brain MRI within 2 weeks after stroke onset

Exclusion Criteria:

* any clinically significant or unstable medical disorder or neuropsychiatric comorbidity

Primary outcomes:
measure: Fractional anisotropy
timeFrame: 2 weeks to 3 months after stroke onset
Secondary outcomes:
measure: Fractional anisotropy
timeFrame: 2 weeks to 3 months after stroke onset
measure: Fractional anisotropy
timeFrame: 2 weeks to 3 months after stroke onset
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Gangnam-gu
Study officials:
References:
citation: Park E, Lee J, Chang WH, Lee A, Hummel FC, Kim YH. Differential Relationship between Microstructural Integrity in White Matter Tracts and Motor Recovery following Stroke Based on Brain-Derived Neurotrophic Factor Genotype. Neural Plast. 2020 Sep 22;2020:5742421. doi: 10.1155/2020/5742421. eCollection 2020.
Clinical trial NCT06555887: Anterior Discectomy Surgery With Arthrodesis in Degenerative Spinal Canal sténoses. (ICASC)
Official title: Anterior Discectomy Surgery With Arthrodesis in Degenerative Spinal Canal Stenoses: a Descriptive Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lumbar Canal Stenosis
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2024-08-15
Enrollment: 14
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Anterior surgery of central lumbar sténoses

Brief summary: Single-center retrospective study to characterize changes in the functional capacity of patients (change in Oswestry Desability Index (ODI)) undergoing anterior approach surgery for the management of symptomatic lumbar spinal stenosis between the pre-surgical period and the first assessment 6 months after surgery.


Eligibility criteria: Inclusion Criteria:

* anterior surgical management (ALIF or LLIF)
* symptomatic lumbar degenerative pathology (L1-L2 to L5-S1), objectified on MRI (Schizas B, C, D)
* period from June 2017 to December 2019

Exclusion Criteria:

* Traumatic sprains
* History of decompression after the operated stage
* Operated from a later time at the same time
* Scolioses with Cobb angles greater than 10°
* Patients under judicial protection
* Refusal to participate

Primary outcomes:
measure: characterize the evolution of functional capacity in patients undergoing anterior approach surgery for the management of symptomatic lumbar spinal stenosis
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References:
Clinical trial NCT03019887: Correlation Between Cognitive Function and Relapse of Schizophrenia Regarding Dose Reduction
Official title: Correlation Between Cognitive Function and Relapse of Schizophrenia Regarding Dose Reduction in Patients Undergoing High-dose Antipsychotic Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia Relapse
Lead sponsor: Juntendo University
Sponsor class: OTHER
First posted: 2017-01-13
Enrollment: 139
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To reduce antipsychotics to under 1000mg in patients with schizophrenia taking more than 1000mg/day and to evaluate relationship between relapse and cognitive function.

Detailed description: We attempted to reduce the dose of antipsychotics to ≤1000-mg chlorpromazine eq./day. The dose was gradually reduced at a rate of ≤50-mg chlorpromazine eq./week, and the reduction was discontinued if the subjects relapsed. The differences in baseline cognitive function were analyzed between the patients with no relapse and relapse groups.

Eligibility criteria: Inclusion Criteria:

* inpatients with a diagnosis of schizophrenia, and
* those in the chronic phase receiving mean daily antipsychotic doses exceeding 1000-mg chlorpromazine eq./day.

Exclusion Criteria:

* mental retardation,
* substance abuse or dependence,
* a history of major head trauma,
* serious medical or neurological disorders, or
* depot antipsychotic injections within the previous 3 months and electroconvulsive therapy within the previous 6 months

Primary outcomes:
measure: Number of Participants With Relapse
timeFrame: One year after the baseline cognitive function test or three months after the end of dose reduction, whichever came first.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Okada hospital
name: Takahashi Tadashi
role: STUDY_CHAIR
affiliation: Okada hospital
name: Mikiro Saito
role: STUDY_CHAIR
References: