louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06131320: Brain Lesion and Visuospatial Impairment in CP Child
Official title: Visuo-spatial Profile in Children with Cerebral Palsy Born At Term or Not and Anatomical Correlation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Children with Cerebral Palsy
Keywords: Cerebral Palsy, child, visuo-spatial disorder, brain lesion
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-11-14
Enrollment: 150
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children coming for out-patient consultation at the paediatric rehabilitation unit of the Hospices Civils de Lyon for a CP diagnosis

Brief summary: Children with cerebral palsy (CP) show varying degrees of motor impairment and movement disorders whose perceptive-visual contribution has yet to be established. The literature reports that children with CP have more frequent neuro-visual disorders. The link between the location and size of the brain lesion and neurovisual symptomatology has yet to be explored.

In this retrospective clinical data study, we will investigate in children with PC whether there is an anatomo-clinical correlation between visuo-spatial disorders is the brain injury of interest to the dorsal visual pathway. We will explore the volume of grey and white matter parietal involvement.

To test visuo-spatial disorders, we will use the PVSE (Visuo-Spatial Elementary Perception) test which does not require motor skills or language and is therefore suitable for children with a PC. This test will make it possible to better identify the deficit or deficits in order to adapt an early remediation. It could serve as a reference for comparing several pathologies/etiologies.


Eligibility criteria: Inclusion Criteria:

* Male or female aged 4 to 18 yo
* With a CP diagnosis
* With PVSE test completion during his/her regular follow-up
* With a cerebral MRI scan during his/her regular follow-up

Exclusion Criteria:

- With an incomplete PVSE test or whose interpretation was deemed unreliable by the rater

Primary outcomes:
measure: PVSE test results: total score and 8 sub-scores (length perception, size perception, angle comparison, midline localization, position perception, position selection, occipital score and parietal score.)
timeFrame: At the inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Pediatric rehabilitation unit of the Hospices Civils de Lyon
Study officials:
References:
Clinical trial NCT00768820: The Psychiatric and Cognitive Phenotypes in Velocardiofacial Syndrome
Official title: The Psychiatric and Cognitive Phenotypes in Velocardiofacial Syndrome (VCFS), Williams Syndrome (WS)and Fragile X Syndrome Characterization, Treatment and Examining the Connection to Developmental and Molecular Factors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Velocardiofacial Syndrome
Williams Syndrome
Fragile X Syndrome
Keywords: Velocardiofacial syndrome
Williams syndrome
fragile X syndrome
cognitive phenotype
psychiatric phenotype
Lead sponsor: The Chaim Sheba Medical Center
Sponsor class: OTHER
First posted: 2008-10-08
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to investigate the Psychiatric and Cognitive Phenotypes in Velocardiofacial Syndrome (VCFS), Williams Syndrome (WS)and Fragile X Syndrome Characterization, Treatment and Examining the Connection to Developmental and Molecular Factors


Eligibility criteria: Inclusion Criteria:

* chromosomal deletion proven by FISH examination

Exclusion Criteria:

Primary outcomes:
measure: Measure that are used: psychological measures, molecular tests, responsiveness to medical treatments
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Petach-Tikva
country: Israel
facility: Schneider Children's Mediac Center of Israel
Study officials:
References:
Clinical trial NCT02235220: Reduction of Masticatory Muscle Activity by Restoring Canine Guidance
Official title: Reduction of Masticatory Muscle Activity by Restoring Canine Guidance With Composite Resin Fillings in Patients With Bruxism.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bruxism
Myopathy
Muscular Activity
Keywords: Bruxism
Lead sponsor: University of Kiel
Sponsor class: OTHER
First posted: 2014-09-09
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study it is to be evaluated wether a restoration with composite resin fillings to reestablish a canine guidance will reduce masticatory muscle activity in patients with bruxism.

Detailed description: 30 patients showing clinical symptoms of bruxism receive treatment within this clinical trial. Typical symptoms like pain or tenseness of the masticatory muscles, headache or abrasions are mandatory preconditions. Exclusion criteria are a present treatment with a biteguard or a sufficient canine guidance.

In the first session a detailed history, a dental status and a clinical functional status are recorded. The baseline situation is documented by taking impressions with alginate of the maxilla and mandible for diagnostic study models. Following this procedure a first measurement of the muscular activity is conducted for seven days with the Grindcare device.

After four weeks without any intervention a second measurement is conducted again for seven days.

In the next session the canine cusps are restored with composite fillings. Finally a sufficient canine guidance should be present. In the same session a second impression of the maxilla is taken. A third measurement is conducted, again followed by four weeks without any intervention.

At last another impression of the maxilla is obtained and a final measurement for seven days is conducted.

At the first examination and after the third measurement of the masticatory muscle activity the patients fill out the questionnaire of the Oral Health Impact Profile in order to allow for the assessment of possible functional restraints and mental interferences.

Eligibility criteria: Inclusion Criteria:

* patients show signs of bruxism
* no canine guidance is present
* no prosthodontic restorations of the canine are present

Exclusion Criteria:

* a sufficient canine guidance is present

Primary outcomes:
measure: Reduction of masticatory muscular activity
timeFrame: 13 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Kiel
name: Matthias Kern, DDS, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05058820: Post Facilitation Stretch Versus Active Isolated Stretching Along With Deep Friction Massage in Wallet Sciatica.
Official title: Effects of Post Facilitation Stretch Versus Active Isolated Stretching Along With Deep Friction Massage in Wallet Sciatica.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Wallet Sciatica
Keywords: Active Isolated stretching
Deep friction massage
Post Facilitation stretching
Piriformis syndrome
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-09-28
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the effects of post facilitation stretch and active isolated stretch along with deep friction massage on pain pressure threshold of trigger points, disability, muscle length, and hip joint range of motion in wallet sciatica.

Detailed description: Literature shows the effectiveness of both techniques post facilitation stretch and active isolated stretch but didn't report any comparison. In this study, investigator diagnosed the patients with wallet sciatica who came with the complaint of low back pain. Both techniques were compared to determine the effectiveness in patients with wallet sciatica having trigger points.

Eligibility criteria: Inclusion Criteria:

* Pain (Grade greater than 3)
* Chronic pain (greater than 3 months) buttock pain.
* Patients with piriformis tightness less than 40 degrees.
* Patients with active trigger points of the piriformis.

Exclusion Criteria:

* Patient with tumor
* Patients with cognitive problems.
* Recent or history of hip trauma or injury.
* Recent abdominal surgery.
* Any other orthopedic or neurological condition of hip and lumbar spine

Primary outcomes:
measure: Pain pressure threshold
timeFrame: 18 days
measure: Disability
timeFrame: 18 days
measure: Piriformis Muscle Length
timeFrame: 18 days
measure: Hip joint range of motion
timeFrame: 18 days
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Ali Ahmad Physio Care, F-7/2
state: Fedral
city: Rawalpindi
country: Pakistan
facility: Railway General Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Momena Shahzad, MS-OMPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00813020: A Clinical Trial Investigating the Comparison of Three Different Concentrations of NN9535 in Healthy Male Subjects
Official title: A Randomised, Single Centre, Double-blind, Incomplete Block Trial to Test for Equivalence Between Subcutaneous Injections of the GLP-1 Analogue NN9535 in 1 mg/ml, 3 mg/ml and 10 mg/ml Concentrations in Healthy Male Subject
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-12-22
Enrollment: 44
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this clinical trial is to investigate whether differences exist between three different concentrations of the drug, NN9535, administered in healthy male subjects in equal doses.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects, based on an assessment of medical history, physical examination and clinical laboratory data at screening, as determined by the Investigator
* Body weight between 80 kg and 110 kg (both inclusive)
* Body Mass Index (BMI) between 18 and 27 kg/m2, both inclusive
* Fasting plasma glucose max 108 mg/dl (6.0 mmol/l)

Exclusion Criteria:

* Known or suspected allergy to trial product(s) or related products
* Previous participation in this trial (randomisation)
* The receipt of any investigational medicinal product within 3 months prior to this trial
* Subjects who have had a clinically relevant illness within 4 weeks of dosing
* History of or presence of cancer, diabetes, or any clinically relevant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders
* Regular smoking as defined by smoking 1 or more cigarettes or the equivalent amount of tobacco pr day, and unable to refrain from smoking during the entire confinement period

Primary outcomes:
measure: AUC0-8 (NN9535), the area under the plasma NN9535 plasma-concentration-time curve in the interval 0-8 after investigational medicinal product administration
timeFrame: a 28 day time period
Secondary outcomes:
measure: Cmax of the plasma NN9535 curve
timeFrame: a 28 day time period
Other outcomes:
Locations:
city: Berlin
country: Germany
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT03396120: The FVC/DLCO Ratio is a Useful Predictor of Pulmonary Hypertension in Patients With Interstitial Lung Disease
Official title: The FVC/DLCO Ratio is a Useful Predictor of Pulmonary Hypertension in Patients With Interstitial Lung Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Interstitial Lung Disease
Pulmonary Hypertension
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-01-10
Enrollment: 95
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: - ILD was diagnosed on the basis of clinical, radiological and functional assessments

Brief summary: Pulmonary hypertension (PH) is a common disorder among patients with interstitial lung disease (ILD). The symptoms are usually nonspecific and overlooked. Thus, a noninvasive screening modality is recommended for early detection of PH because of its potentially significant impact on treatment strategy and clinical outcomes.

Objectives: To evaluate the usefulness of assessing forced vital capacity (FVC%), diffusion capacity of the lung for carbon monoxide (DLCO%), and FVC%/DLCO% ratio to predict pulmonary hypertension among patients with ILDs.


Eligibility criteria: Inclusion Criteria:

* This retrospective study included all patients diagnosed with interstitial lung disease (ILD) who were followed up by the chest department of a tertiary hospital between September 2016 and January 2017

Exclusion Criteria:

* patients with occupational history
* collagen vascular disease predisposing them to lung disorders
* patients who could not undergo pulmonary function testing

Primary outcomes:
measure: value of FVC/DLCO in predicting PAH in IPF
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: AssiutU
city: Assiut
country: Egypt
facility: Pulmonology Departments
Study officials:
References:
Clinical trial NCT06293820: A Study Of TL-925 For The Treatment of AC
Official title: A Single Center, Randomized, Double-masked, Vehicle-controlled Phase 2b Study Evaluating the Safety and Efficacy of TL-925 Ophthalmic Emulsion 0.1% Compared to Vehicle for the Treatment of Allergic Conjunctivitis in the Conjunctival Allergen Challenge (Ora CAC®) Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Conjunctivitis
Lead sponsor: Telios Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2024-03-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this prospective, Phase 2, randomized, double-masked, vehicle controlled study, approximately 70 eligible subjects will be randomized 1:1 to receive either TL-925 or placebo as topical ophthalmic eye drops administered bilaterally.

The study comprises of a screening and treatment period using the conjunctival allergen challenge model to evaluate TL-925 for the treatment of allergic conjunctivitis.


Eligibility criteria: Inclusion Criteria:

* Individuals aged 18 years or older
* Female subjects of childbearing potential and their male partners must both use a highly effective contraception method during the study.
* Documented history of ocular allergies and a positive skin test reaction to a seasonal (grass, ragweed, tree pollen) or perennial (cat dander, dog dander, dust mites, cockroach) allergen as confirmed by an allergic skin test conducted at Visit 1 or within the past 60 months.
* Calculated best-corrected visual activity of 0.7 LogMAR or better
* Positive bilateral CAC reaction

Exclusion Criteria:

* Any systemic or ocular disease currently producing ocular redness and/or ocular discomfort, or that may interfere with the conduct of the study.
* Any ocular surgical intervention within the last 3 months OR refractive surgery within the last 6 months
* Any ongoing ocular infection (bacterial, viral or fungal)

Primary outcomes:
measure: Ocular Itching
timeFrame: 3, 5 and 7 minutes after CAC
measure: Conjunctival Redness
timeFrame: 7, 15 and 20 minutes after CAC
Secondary outcomes:
Other outcomes:
Locations:
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
Study officials:
References:
Clinical trial NCT04319120: Pilot Study of Description of Cicatrisation Rates of Digital Ulcers in Systemic Scleroderma
Official title: Pilot Study of descriPtion of cicatriSation Rates of Digital Ulcers in Systemic scleroDerma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Scleroderma, Systemic
Keywords: Scleroderma - Digital Ulcers
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with systemic scleroderma

Brief summary: To make an updated inventory of digital ulcer care protocols in scleroderma patients and to specify the French data on monthly healing rates and local care with patients in care centers experience, and thus to know the impact of ulcers in different dimensions To evaluate the rate of healed digital ulcers at the end of the study


Eligibility criteria: Inclusion Criteria:

* Patient with systemic scleroderma according to the ACR / EULAR 2012 criteria
* Patient with one or more active digital ulcers
* Patient with internet access and camera or smartphone

Exclusion Criteria:

* Minor patients
* Patient deprived of liberty or subject to a court order
* Patient subject to a legal protection measure
* Pregnant or lactating woman
* Patient unable to complete the questionnaires

Primary outcomes:
measure: Number of digital ulcers
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Bordeaux Hospital
city: Limoges
country: France
facility: Limoges Hospital
city: Toulouse
country: France
facility: Toulouse Hospital
Study officials:
References:
Clinical trial NCT00195520: Study Evaluating Totelle® in Menopausal Symptoms and Sexual Function
Official title: An Open Assessment of the Effect of Low-Dose Totelle® 1 mg on Menopausal Symptoms, Sexual Function and Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hot Flashes
Sleep Disorders
Keywords: Menopause
Sleep Disorder
Hot Flashes
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 100
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the tolerability, bleeding patterns and acceptability of Totelle® 1mg administered to a population of Brazilian women in a continuous combined regime for hormone replacement therapy.


Eligibility criteria: Inclusion Criteria:

* Intact uterus
* Generally health postmenopausal women 45 to 60 years of age, inclusive
* Sexually active
* No hormone replacement therapy within the 90 days immediately prior to the screening evaluation.

Exclusion Criteria:

* Known or suspect estrogen-dependent neoplasia
* Known hypersensitivity to estrogens, progestins, or other ingredients of Totelle
* Use of any estrogen, progestin, androgen containing medications or tibolone within 12 weeks before screening.

Primary outcomes:
measure: To evaluate the tolerability, bleedeing patterns and acceptability of Totelle 1mg administered to a population of Brazilian women in a continuous combined regime for hormone replacement therapy.
Secondary outcomes:
measure: To evaluate the effects of Totelle 1 mg on sexual function and quality of life.
Other outcomes:
Locations:
city: Jundiai
country: Brazil
state: Sao Paulo
city: Sao Paulo
country: Brazil
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01906320: Effects of a High Intensity Resistance Training in Muscular Strength, Agility, and Body Composition of Anorexia Nervosa Restricting Type Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anorexia Nervosa Restricting Type
Keywords: anorexia nervosa
restricting type
muscle strength
exercise
body composition
physical activity
Lead sponsor: Universidad Europea de Madrid
Sponsor class: OTHER
Collaborators: name: Hospital Infantil Universitario Niño Jesús, Madrid, Spain
First posted: 2013-07-24
Enrollment: 44
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim is to test the hypothesis that high-resistance training for 8 weeks, following the recommendations for healthy adolescents, is capable of eliciting increases in muscle strength, agility, skeletal muscle mass, and functional capacity without losing weight, body mass index (BMI) or fat mass in anorexia nervosa restricting type patients. Further, we hypothesize that the effects produced by the high-resistance training program will be maintained 4 weeks following the completion of the training program.


Eligibility criteria: Inclusion Criteria:

* diagnosed with anorexia nervosa restricting type
* age ≤16 years
* receiving psychological therapy 3 days/week, and daily life tracing (including diet)
* BMI \>14.0 kg/m2

Exclusion Criteria:

* being excessive exercisers (6 hours per week moderate to vigorous physical activity \[1952 counts/min\] upon admission)
* not being able to perform physical activity.

Primary outcomes:
measure: Changes in Muscular Strength
timeFrame: 3 times (week 0, week 8, week 12)
measure: Changes in Agility
timeFrame: 3 times (week 0, week 8, week 12)
measure: Changes in Body Composition - Anthropometry
timeFrame: 3 times (week 0, week 8, week 12)
measure: Functional Capacity
timeFrame: 3 times (week 0, week 8, week 12)
Secondary outcomes:
measure: Changes in Spontaneous Physical Activity habits - Accelerometry
timeFrame: 2 times (week 0, week 8)
measure: Changes in perceived health-related QoL
timeFrame: 2 times (week 0, week 8)
Other outcomes:
Locations:
city: Villaviciosa de Odon
country: Spain
facility: Universidad Europea
state: Madrid
city: Madrid
country: Spain
facility: Hospital Infantil Universitario Niño Jesús
Study officials:
References: