louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02266121: Improving Cognitive Aptitudes With tDCS in Patients With Multiple Sclerosis
Official title: Improving Cognitive Aptitudes With tDCS in Patients With Multiple Sclerosis / Améliorer Les capacités Cognitives Par tDCS Chez Les Patients Souffrants de sclérose en Plaques
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Relapsing Remitting Multiple Sclerosis
Secondary-progressive Multiple Sclerosis
Cognitive Deficits
Motor Deficits
Keywords: Multiple Sclerosis
MS
Cognitive deficits
Motor deficits
Fatigue
Nervous System Diseases
Brain Diseases
Brain stimulation
Working memory
Motor learning
Central Nervous System Diseases
Neuropsychological rehabilitation
Lead sponsor: University Hospital of Mont-Godinne
Sponsor class: OTHER
Collaborators: name: Université Catholique de Louvain
name: Teva Pharmaceuticals USA
First posted: 2014-10-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Noninvasive brain stimulations (NIBS) will be used in MS patients with cognitive impairments to enhance their cognitive aptitudes.

Detailed description: tDCS will be used in a sham-controlled, double-blind, randomized, cross-over control trial in MS patients suffering from cognitive impairments and/or motor deficits. After informed consent and recruitment, patients will be randomly (computer method) allocated to real or sham tDCS, that will be applied during working memory and attentional tasks. A few days/weeks after completing one arm, the patients will enter the other arm (double-blind cross-over design).

Baseline and follow-up outcomes about cognitive aptitudes, motor tasks and fatigue will be collected.

Eligibility criteria: Inclusion Criteria:

* MS patients with relapsing remitting MS/secondary progression MS (based on the 2010 revised McDonald criteria)
* Cognitive deficits
* Motor deficits

Exclusion Criteria:

* contraindication to tDCS (seizure or epilepsy, metal in the head, ...)
* major psychiatric conditions or major depression
* coexisting instable medical condition
* substance or alcohol abuse
* regular intake of drug that strongly modulate brain excitability
* major sequels from MS preventing participation in the study
* pregnancy

Primary outcomes:
measure: Enhancement of Cognitive aptitudes with tDCS
timeFrame: from baseline to 4 weeks after the intervention
Secondary outcomes:
measure: Enhancement of Motor skills with tDCS
timeFrame: from baseline to 4 weeks after the intervention
measure: Impact on Fatigue and Enhancement of Cognitive performances with tDCS
timeFrame: from baseline to 4 weeks after the intervention
Other outcomes:
Locations:
city: Yvoir
country: Belgium
facility: Department of Neurology, CHU Dinant Godinne UcL Namur
state: Namur
Study officials:
References:
Clinical trial NCT00465621: Dose Response Study of AL-37807 Ophthalmic Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension
Official title: Dose Response Study of AL-37807 Ophthalmic Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Open-Angle Glaucoma
Ocular Hypertension
Keywords: Open-angle glaucoma
ocular hypertension
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2007-04-25
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of thie study is to compare the safety and IOP-lowering efficacy of AL-37807 Ophthalmic Solution 0.05%, 0.1% and 0.2% dosed QD AM to Xalatan dosed QD PM and Vehicle in patients with open-angle glaucoma or ocular hypertension


Eligibility criteria: Inclusion Criteria:

* Open-angle glaucoma
* ocular hypertension

Exclusion Criteria:

- VA worse than 0.60

Primary outcomes:
measure: Mean IP Change from Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Atlanta
state: Georgia
Study officials:
affiliation: Alcon Research
name: Theresa Landry
role: STUDY_DIRECTOR
References:
Clinical trial NCT02067221: Comparison of Surgical Outcomes Between MPCNL and RIRS
Official title: Comparison of Surgical Outcomes in the Treatment of Renal Stones Larger Than 1 Centimeters Between MPCNL and RIRS: a Single-center, Randomized, Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Stone
Keywords: percutaneous nephrolithotomy
renal calculi
ureteroscopy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: SK Telecom Consortium
First posted: 2014-02-20
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this research is to investigate the surgical outcomes of minimally invasive percutaneous nephrolithotomy(MPCNL) and retrograde intrarenal surgery (RIRS)for patients with renal stone larger than 1cm.

Detailed description: It is pointed out that there is the disadvantage of conventional PCNL technique which showed dramatic decrease in Hb and renal damage even though it has some advantages of a short operation time and a high stone-free rate. MPCNL and RIRS has recently been considered as very efficacious methods.

Eligibility criteria: Inclusion Criteria:

* The person who has been diagnosed with renal stone larger than 1cm renal and who has been supposed to undergo MPCNL or RIRS.
* The person who signed up for participation and agree with intention of clinical test.

Exclusion Criteria:

* The patient whose medical record has been omitted from database.
* The patient who has an anatomical abnormality of urinary tract and/or metabolic illness
* The patient who do not agree with the intention of the clinical study.

Primary outcomes:
measure: stone-free rate
timeFrame: postoperative 1 month
Secondary outcomes:
measure: pain
timeFrame: postoperative 1 day
measure: hemoglobin drop
timeFrame: postoperative 1 day
measure: occurrence of complications
timeFrame: postoperative 1 day, and the postop 1month at OPD
measure: hospital stay
timeFrame: postoperative 1 month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
Study officials:
affiliation: SMG-SNU Boramae Medical Center
name: Sung Yong Cho, Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT03222921: OpenGo Sensor Insole in Open Wedge HTO
Official title: OpenGo Sensor Insole in Open Wedge HTO
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Tibia; Angulation
Keywords: high tibial osteotomy
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
Collaborators: name: Berufsgenossenschaftlichen Unfallklinik Tuebingen
First posted: 2017-07-19
Enrollment: 27
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 undergoing high tibial osteotomy

Brief summary: Weight bearing in 40 patients undergoing open wedge high tibial osteotomy (HTO) will be studied during 12 weeks for their post-operative weight bearing using a pressure insole.

Detailed description: Forty patients who are planned for open wedge HTO with deformity in the proximal tibia will be included in the study. The open wedge HTO will be performed in the well known biplanar technique and the TomoFix plate will be used as fixation plate. To analyze the peak pressure and if the patients are able to reassemble the partial weight bearing/ the full weight bearing the OpenGo Sensor Insole (Moticon) will be used during the first 12 weeks after surgery. In addition, x-rays will be analyze for the alignment and angles and clinical scores will be gathered to investigate patient reported outcomes.

Eligibility criteria: Inclusion Criteria:

* Indication for high tibial osteotomy

Exclusion Criteria:

* Impairment of the shoulder which has an influence on the ability for partial weight bearing

Primary outcomes:
measure: Partial weight bearing
timeFrame: 2 weeks post-OP
Secondary outcomes:
measure: Full weight bearing
timeFrame: 12 weeks post-OP
measure: Weight bearing pre- vs. post-OP
timeFrame: 12 weeks post-OP
measure: Patient reported outcomes
timeFrame: 12 weeks post-OP
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: BGU Tübingen
Study officials:
affiliation: AO Clinical Investigation and Publishing Documentation
name: Katrin Simioni, Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05981521: Paternal Age and Fetal Aneuploidy
Official title: Exploring the Association Between Paternal Age and Trisomy 21 Screening Results.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Trisomy 21
Lead sponsor: Clinique Ovo
Sponsor class: INDUSTRY
First posted: 2023-08-08
Enrollment: 30000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women who underwent Optimo trisomy 21 screening at clinique ovo between January 2014 to June 2023

Brief summary: Trisomy 21, commonly known as down syndrome, is the most common chromosomal abnormality in humans. Advanced maternal age (AMA) is a well-recognized risk factor for trisomy 21, with the risk increasing significantly beyond the age of 35. Research on the effects of paternal age on the prenatal risk of trisomy 21 is lacking, with inconsistent findings in the literature.

The Harmony® prenatal test is an Non-Invasive Prenatal Testing (NIPT) that screens maternal blood for chromosomal abnormalities in the Cell-Free Fetal DNA (cfDNA). The harmony® prenatal test can detect conditions such as trisomy 13, 18, and 21, as well as sex chromosome abnormalities.

The Optimo test is a prenatal screening test that screens for trisomies 13, 18 and 21 in the developing fetus using extended biochemical screening in maternal. The Optimo test has shown high sensitivity and specificity in detecting trisomy 21.


Eligibility criteria: Inclusion Criteria:

* Pregnant women aged 18 years or older (at the time of trisomy 18 and 21 screening) and who were able to complete the questionnaire in either French or English
* Pregnant women who completed the entire trisomy 21 screening process at clinique ovo were included

Exclusion Criteria:

* Patients who did not indicate the male partner/donor's age were excluded
* Patients who did not complete or sign the clinical information form

Primary outcomes:
measure: Trisomy 21 screening results
timeFrame: 3 to 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Clinique Ovo
state: Quebec
Study officials:
affiliation: clinique ovo R&D department
name: Jacques I Kadoch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02288221: Safe & Easy Environment at Home for Patients Presenting a Frail Syndrome
Official title: SafEE : Safe & Easy Environment at Home for Patients Presenting a Frail Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Deterioration
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2014-11-11
Enrollment: 4
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: All over the world the increasing prevalence of chronic disorders and its impact on functional decline is challenging the sustainability of health care systems. Older individuals also frequently experience the reversible "frailty syndrome", which overlaps with chronic diseases, increasing incidence of disability.

Building a global system aiming to take in charge all causes leading to loss of autonomy is a rather complicated task involving numerous Information and Communication technologies (ICT) solutions which are not always easy to use in everyday life.

The SafEE (Safe Easy Environment) project aim is to improve the safety, autonomy and quality of life of older people at risk.

The SafEE project develop non pharmacological therapeutic through diferent ICT (stimulation aromatherapy automatic fragrance, training interface based on Kinect sensor...) .

The goal of this study is to validate the acceptability, sensitivity and efficacy of the systems.

Detailed description: The non pharmacological therapeutic will be install at patient's home :

* aromatherapy,
* music therapy,
* cognitive training in multimedia application offering cognitive games.

Also smart phone will be given to the patient :

* to help him move with a geolocation application,
* to remind him of his daily needs (shopping lists, people to call, etc ...) with an alert apllication.

Eligibility criteria: Inclusion Criteria:

* Male or female age ≥ 60 years with memory complaint
* Score at the Mini Mental Test (MMSE) ≥ 26.
* Score at the Clinical Dementia Rating Scale (CDR) ≤ 0.5.

Exclusion Criteria:

* Sensory defect (visual or olfactory) preventing the patient to perfectly meet therapeutic solutions.
* Prescription new psychotropic medication (hypnotic, anxiolytic, antidepressant, antipsychotic) in the week preceding the assessment.
* Subject epileptic.
* Subject vulnerable

Primary outcomes:
measure: Time spent by the patient using the non-therapeutic solutions
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: Institut Claude Pompidou
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Renaud DAVID, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT05144321: Twin Pregnancy Cohort
Official title: Constitution of a Prospective Twin Pregnancy Cohort in Order to Study the Risk Factors for Obstetric Complications COGEM
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pregnant With Complication
Twin Pregnancy With Antenatal Problem
Keywords: Pregnant women
Environment
Adverse outcome
Age >18 years
Gestational age >25 weeks
Delivery of a twin pregnancy
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-12-03
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women delivering a twin pregnancy

Brief summary: The investigators know that multiple factors are involved in the risk of obstetric complications. The twin pregnancy model appears to be an interesting model for a bio-statistical analysis of data collected in the context of a complete pregnancy, in particular because it can reveal differences for a common exposure.

The aim of the study is to constitute a prospective cohort of twin pregnancies. The collection of data on the health of mothers, pregnancies, childbirth, and the health of twins at birth should make it possible to reveal results with sufficient statistical power for a prospective study.


Eligibility criteria: Inclusion criteria:

* Pregnant women
* Delivery of a twin pregnancy
* Gestational age \>25 weeks
* Age \>18 years

Exclusion criteria:

* Singleton pregnancy
* Miscarriage

Primary outcomes:
measure: maternal adverse outcome
timeFrame: day 1
Secondary outcomes:
measure: Neonatal adverse outcome
timeFrame: day 1
measure: Obstetrical adverse outcome
timeFrame: day 1
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Florent FUCHS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02043821: Maintenance Chemotherapy for Metastatic Colorectal Carcinoma and Biological Marker
Official title: Maintenance Chemotherapy for Metastatic Colorectal Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metastatic Colorectal Cancer
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2014-01-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Colorectal cancer patients with metastases (mCRC) at response under first-line chemotherapy are candidates for an convenient maintenance treatment.

Detailed description: Colorectal cancer is one of the most common malignant tumors, with the morbidity of approximate 100 million cases per year. About 40% of patients present with metastatic (stage IV) colorectal cancer at the time of diagnosis, and about 25% of patients with local lesion will ultimately develop metastatic disease.Therefore, our study is designed to investigate that colorectal cancer patients with metastases (mCRC) at response under first-line chemotherapy are candidates for an convenient maintenance treatment.

Eligibility criteria: Inclusion Criteria:

- Age between 18 and 75 years Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1 histologically confirmed colorectal cancer with inoperable locally advanced or recurrent and/or metastatic disease Life expectancy of at least 3 months Intact organ function, including complete blood counts (CBC) showing normal values or any toxicity limited to grade 1 and blood chemistry (SMA) showing liver and renal functions \< 1.5 upper normal limit (UNL).

Patients who achieved objective response or stable disease after 16-24 weeks first line chemotherapy Signed informed consent

Exclusion Criteria:

- Known hypersensitivity to capecitabine Concurrent any other cancer (except BCC or squamous cell carcinoma of skin). Inability to adhere to monthly visits to the oncology unit for evaluation. Presence of brain metastases. Previous radiotherapy to the only site of measurable disease. Evidence of severe or uncontrolled systemic disease No previous chemotherapy for metastatic disease Positive serum pregnancy test in women of childbearing potential unresolved bowel obstruction or malabsorption syndrome

Primary outcomes:
measure: DDC:Duration of Disease Control
timeFrame: 2 years
Secondary outcomes:
measure: OS:Overall Survival
timeFrame: 2 years
measure: DCR:Disease Control Rate
timeFrame: 2 years
Other outcomes:
measure: Safety
timeFrame: 2 years
Locations:
Study officials:
affiliation: Beijing Chao Yang Hospital
name: Guangyu An, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00808821: Pharyngeal Carriage Rates and Genetic Typing of Group A Streptococcus and Streptococcus Pneumonia Among Israeli Military Basic Trainees
Official title: Pharyngeal Carriage Rates and Genetic Typing of Group A Streptococcus and Streptococcus Pneumonia Among Israeli Military Basic Trainees
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carriage
Group A Streptococcus
Streptococcus Pneumonia
Lead sponsor: Medical Corps, Israel Defense Force
Sponsor class: OTHER
First posted: 2008-12-16
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The study is aimed at assessing pharyngeal and nasopharyngeal Streptococcus pneumonia carriage and pharyngeal Group A streptococcus carriage among field units new recruits.


Eligibility criteria: Inclusion Criteria:

* Israeli Military Basic Trainee

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00750802: A Sedation/Cognition/EEG Study Using AZD6280 and Comparator
Official title: A Phase 1, Single Centre, Single Dose, Double-Blind, Double-Dummy, Four-Way Crossover, Placebo-Controlled, Randomized Study to Investigate the Effects of AZD6280 on Sedation, Cognition and EEG in Comparison With Lorazepam in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: Phase I
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-09-11
Enrollment: 17
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to determine the effects of AZD6280 compared to lorazepam on sleepiness, concentration and brain activity.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female subjects aged 18 to 55 years (inclusive) on Day 1.
* Female subjects must be of non-child bearing potential.

Exclusion Criteria:

* Clinically significant illness within 2 weeks before the study start.
* Enrollment in another concurrent investigational study or intake of an investigational drug within 30 days or intake of an investigational drug within a period of 5 half lives of that drug prior to the screening visit
* Blood loss in excess of 200 mL within 30 days of Day -2, in excess of 400 mL within 90 days of Day -2, or in excess of 1200 mL within 1 year of Day -2
* Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology or urinalysis

Primary outcomes:
measure: Evaluation of the pharmacodynamic effects of AZD6280 by central nervous system function tests
timeFrame: Test batteries will be performed at specified times both before and following study drug administration
Secondary outcomes:
measure: Evaluation and characterization of the pharmacokinetics of AZD6280
timeFrame: Blood samples will be taken during the study.
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Research Site
Study officials:
References:
Clinical trial NCT04081402: A Phase 1/3 Clinical Trial to Evaluate the Safety and Efficacy of HUTOX Compared to Botox® in Subjects With Moderate to Severe Crow's Feet Lines
Official title: A Phase 1/3 Clinical Trial to Evaluate the Safety and Efficacy of HUTOX Compared to Botox® in Subjects With Moderate to Severe Crow's Feet Lines
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Crow's Feet Lines
Lead sponsor: Huons Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-09-09
Enrollment: 290
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Phase 1/3 Clinical Trial to Evaluate the Safety and Efficacy of HUTOX Compared to Botox® in Subjects With Moderate to Severe Crow's Feet Lines


Eligibility criteria: Inclusion Criteria:

* Bilaterally symmetrical moderate-to-severe CFL at maximum smile on the FWS as rated by the investigator

Exclusion Criteria:

* Volunteer who has history of any diseases following. (myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis etc.)
* From screening, Subject who get a plastic Surgery within 48 Weeks
* Subject who has skin disorder including infection and scar on injection site
* Subject who takes a medication including skeletal muscle relaxants, Aminoglycoside, lincomycin, anticholinergic drug, benzodiazepine, benzamide etc.
* Subject who takes a medication including anticoagulant, antithrombotic drug except low dose aspirin (below 325 mg/day)
* Any condition that, in the view of the investigator, would interfere with study participation

Primary outcomes:
measure: Change from Baseline of Crow's feet Lines improvement rate [Time Frame: Week 4]
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Huons
Study officials:
References: