louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00103805: Improved Language Acquisition With Levodopa
Official title: Improved Language Acquisition With Levodopa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: language acquisition
plasticity
stroke recovery
associative learning
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2005-02-15
Enrollment: 20
Sex: MALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the non-daily administration of levodopa is effective in boosting semantic language acquisition in healthy subjects.

Detailed description: Our prior work using a between-subject design shows that daily administration of d-amphetamine or the dopamine precursor levodopa over the course of five days markedly improves word learning success in healthy subjects. In this randomized, placebo-controlled, double-blind clinical trial, we probe whether the effect can be replicated using a within-subject design, with administration of levodopa and placebo on alternate days for a total period of 10 days.

The expected scientific results will strengthen the basis for transferring neuromodulatory interventions from the laboratory to stroke patients with language dysfunctions. Because of the heterogeneity of stroke patients, only a within-subject design can be used to probe the effects of pharmacological adjuncts to language therapy.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects
* 20-35 years old
* Right handedness

Exclusion Criteria:

* Neurological/psychiatric/metabolic/cardiac disorders
* Asthma
* Known allergic reactions to one of the experimental drugs
* Other drugs affecting the central nervous system
* Leisure drug ingestion during the past 4 weeks (urine test)
* Smoking cessation during the past 2 weeks
* \> 6 cups of coffee or energy drinks per day
* \> 10 cigarettes per day
* \> 50 grams of alcohol per day

Primary outcomes:
measure: Boost in language learning success through levodopa compared to placebo
Secondary outcomes:
measure: Stability of language learning success after one month
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: Dept. of Neurology, University Hospital Muenster
state: Nordrhein-Westfalen
Study officials:
affiliation: Dept. of Neurology, University of Muenster, Germany
name: Caterina Breitenstein, PhD
role: STUDY_DIRECTOR
affiliation: Dept. of Neurology, University of Muenster, Germany
name: Stefan Knecht, MD
role: STUDY_CHAIR
References:
citation: Knecht S, Breitenstein C, Bushuven S, Wailke S, Kamping S, Floel A, Zwitserlood P, Ringelstein EB. Levodopa: faster and better word learning in normal humans. Ann Neurol. 2004 Jul;56(1):20-6. doi: 10.1002/ana.20125.
citation: Breitenstein C, Wailke S, Bushuven S, Kamping S, Zwitserlood P, Ringelstein EB, Knecht S. D-amphetamine boosts language learning independent of its cardiovascular and motor arousing effects. Neuropsychopharmacology. 2004 Sep;29(9):1704-14. doi: 10.1038/sj.npp.1300464.
Clinical trial NCT02359305: Institutional Audit of the Use of Intravenous Acetaminophen in Infants Undergoing Pyloromyotomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pyloric Stenosis
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2015-02-10
Enrollment: 68
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who presented for pyloromyotomy

Brief summary: This is a retrospective chart review. The objective of the current study is to determine the analgesic efficacy and side effect profile of intravenous acetaminophen when administered to infants undergoing pyloromyotomy. In addition, recovery characteristics of infants who were administered intravenous acetaminophen will be compared to infants who did not receive intravenous acetaminophen to determine if there were any appreciable differences with regard to postoperative discomfort, PACU time, time to oral feeds and hospital discharge.


Eligibility criteria: Inclusion Criteria:

* patients who presented for pyloromyotomy

Exclusion Criteria:

* none

Primary outcomes:
measure: Acetaminophen Dosage
timeFrame: Baseline
measure: Average FLACC Pain Score in the PACU
timeFrame: 0-60 minutes post-operatively
Secondary outcomes:
measure: PACU Time
timeFrame: 45-60 minutes post-operatively
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT02219997: Functional Vision With ACRYSOF® IQ IOLs Blue Light Filtration
Official title: Functional Benefit With ACRYSOF® Natural Chromophore
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: Cataract
Intraocular lens (IOL)
AcrySof
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2014-08-19
Enrollment: 90
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to compare the reaction time (as measured by braking reaction time in seconds during simulated driving) under glare and no-glare conditions in subjects implanted with ACRYSOF® IQ intraocular lenses (IOLs) to subjects implanted with clear IOLs. This study will enroll subjects previously implanted with IOLs in both eyes for at least 3 months.

Detailed description: Subjects completed 2 visits to the investigational site.

Eligibility criteria: Inclusion Criteria:

* Pseudophakes with ACRYSOF® IQ monofocal IOLs or clear (no blue light filter) IOLs in both eyes for at least 3 months.
* Willing and able to understand and sign an informed consent form.
* Corrected visual acuity (CVA) of 20/40 or better.
* Have a valid driver's license.
* Depth perception of at least 100 arc seconds.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Ocular pathology, degeneration, or media opacity.
* Color vision defect.
* Use of ocular or systemic medications that impact macular pigment density or reaction time, including but not limited to, lutein, zeaxanthin, barbiturates, tranquilizers or amphetamines.
* System conditions affecting connective tissue or sensory-motor coordination.
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Change in Braking Reaction Time From No-glare to Glare
timeFrame: Visit 2, up to Day 30
Secondary outcomes:
measure: Change in Braking Reaction Time From No-glare to Glare (Clear IOLs)
timeFrame: Visit 2, Up to Day 30
measure: Change in Braking Reaction Time From No-glare to Glare (ACRYSOF® IQ IOL + Placebo Filter; Clear IOL + BLF)
timeFrame: Visit 2, Up to Day 30
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Sr Clinical Manager, GCRA-Global Med Affairs, Operations
role: STUDY_DIRECTOR
References:
Clinical trial NCT00955097: Evaluation of Intra-operative Ultrasound Contrast Enhancement in the Evaluation of Liver Tumors
Official title: Evaluation of Intra-operative Ultrasound Contrast Enhancement in the Evaluation of Liver Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Liver Tumors
Keywords: Definity
liver tumors
intra operative contrast
liver cancer
hepatic tumors
identify liver tumors
surgery liver tumors
Patients with known hepatic tumors
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2009-08-07
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The primary purpose of this study is to demonstrate the safety and effectiveness of using an intra-operative ultrasound contrast agent(Definity®) for the identification of known liver tumors.

Detailed description: The primary objective of this study is to demonstrate the safety of the use of intra-operative ultrasound contrast (Definity®) administration. The secondary objective of this study is to demonstrate the improved image quality and conspicuity of known liver tumors using contrast enhancement.

Eligibility criteria: Inclusion Criteria:

1. Undergoing a hepatic resection or hepatic ablation of pre-operative visualized liver tumor:
2. ≥ 18 years of age
3. If female of child-bearing potential, negative pregnancy test within 14 days prior to surgery
4. If subject is a sexually active male or a sexually active female of child-bearing potential, subject agrees to use a medically accepted form of contraception from the time of enrollment to completion of all follow-up study visits.
5. IRB-approved informed consent, signed by the subject or the subject's legally authorized representative. ≥ 18 years of age

Exclusion Criteria:

1. Not a suitable candidate for operation

Primary outcomes:
measure: adverse events
timeFrame: 6-weeks post surgery
measure: identification of liver tumors
timeFrame: intra-operative
Secondary outcomes:
measure: improved ablation of liver tumors
timeFrame: 6-weeks post surgery
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Norton Healthcare
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville Hospital
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Robert Martin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06838897: Preoperative Pain Catastrophizing and Intraoperative Analgesia Consumption
Official title: Association Between Preoperative Pain Catastrophizing Scale and Intraoperative Analgesia Consumption in Elective Laparoscopic Cholecystectomy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Catastrophizing Pain
Pain
Keywords: pain
Lead sponsor: Samsun University
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled for elective laparoscopic cholecystectomy.

Brief summary: This observational study aims to evaluate the relationship between the Pain Catastrophizing Scale (PCS) and intraoperative analgesia consumption in patients undergoing laparoscopic cholecystectomy. During the preoperative period, patients will complete the Pain Catastrophizing Scale, the Beck Depression Inventory, and the Beck Anxiety Scale. During the intraoperative period, analgesia nociceptive index (ANI) electrodes will be placed, and remifentanil dosing will be adjusted accordingly. The correlation between preoperative Pain Catastrophizing Scale scores and intraoperative remifentanil consumption will be analyzed.


Eligibility criteria: Inclusion Criteria:

* Patients with ASA scores of I-III
* Patients with Turkish literacy skills.
* Patients scheduled for elective laparoscopic cholecystectomy.

Exclusion Criteria:

* Patients unwillingness to participate in the study.
* Conversion of surgery from laparoscopic to open surgery.
* Patients undergoing emergency laparoscopic cholecystectomy.

Primary outcomes:
measure: Intraoperative remifentanyl requirement
timeFrame: Intraoperative period
Secondary outcomes:
measure: Numeric rating scale for postoperative pain intensity
timeFrame: up to 24 hours
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Samsun Üniversitesi Eğitim Ve Araştırma Hastanesi
state: Ilkadım
Study officials:
References:
Clinical trial NCT02516397: OMNIA Efficacy on Body Fat Mass Reduction
Official title: Randomised Controlled Trial, Double-blind, to Measure Efficiency and Tolerance of a New Food Supplement OMNIA on Body Fat Mass Reduction in Overweight Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Overweight
Keywords: body fat mass reduction
Lead sponsor: Vivatech
Sponsor class: INDUSTRY
First posted: 2015-08-05
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical trial is to evaluate the safety and efficacy of a food supplement OMNIA compared to a placebo in reducing the body fat mass in 70 overweight subjects during 12 weeks treatment.

Detailed description: Overweight and obesity represent a serious public health issue. These conditions are characterized by an abnormal or excessive accumulation of body fat mass and they are related to an increase risk of developing chronic diseases such as cardiovascular, diabetes, arthrosis and certain kind of cancer (breast; colon). It's thus necessary to find new products able to counteract both overweight and obesity.

Omnia is a food supplement based on a Phaseolus vulgaris extract. It has pancreatic amylase inhibition properties.

In the following clinical trial, OMNIA will be administrated to a group of overweight subjects in order to evaluate its efficacy on reducing the body fat mass. Its action will be compared to a placebo administered to a second group of overweight volunteers with the same modalities as OMNIA.

Eligibility criteria: Inclusion Criteria:

* 25≤ BMI\<30 kg/m2
* excess of fat mass
* food habits : 3 meals a day and a glucides intake equivalent to at least 40% of daily energy (i.e.: glucides intake at each meal)
* Able to give a written or verbal informed consent
* Affiliated or beneficiary of social security

Exclusion Criteria:

* Weight loss/gain \> 2kg within the preselection period (2 weeks)
* Abnormal blood results at V0
* Physical activity (sport; lifestyle) modification planned or ongoing during the trial
* Severe pathologies/disorders (bulimia; anorexia; diabetes; cancer...) emerging
* Pregnancy during the study
* Consent withdrawal
* Allergy to Omnia
* observance \<60%
* Investigator or promotor decision

Primary outcomes:
measure: Reduction of body fat mass loss measured by DEXA (Dual-energy X-ray absorptiometry)
timeFrame: 12 weeks
Secondary outcomes:
measure: change from baseline in Body Mass Index (BMI)
timeFrame: 6, 12 weeks
measure: change from baseline on the ratio fat/lean body mass measured by DEXA
timeFrame: 12 weeks
measure: change from baseline on weight
timeFrame: 6, 12 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02936297: Gluten Ingestion Biomarkers in Patients w Gluten Sensitivity and Healthy Controls Peptides in Patients With Non-celiac Gluten Sensitivity and Healthy Patients: A Placebo-controlled Study
Official title: Quantitative Measurement of Stool and Urine Gluten Immunogenic Peptides in Patients With Non-celiac Gluten Sensitivity and Healthy Patients: A Placebo-controlled Study Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non Celiac Gluten Sensitivity
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2016-10-18
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Non-celiac gluten sensitivity (NCGS) is an emerging clinical entity defined as the presence of intestinal and/or extraintestinal symptoms induced by the ingestion or gluten and relieved by a gluten free diet (GFD) in patients without celiac disease or wheat allergy. The pathologic mechanism of the disorder is unknown, and there are no known biomarkers or associated histopathologic findings. In this prospective, randomized controlled trail, we are investigating the utility of patient reported symptom questionnaires, as well as stool gluten and urine quantification tools in patients with NCGS and healthy controls.


Eligibility criteria: Inclusion criteria include

* Patients \> 18 years of age
* Patients willing to maintain gluten free diet for 6 weeks

Exclusion Criteria (NCGS):

* Patients \< 18 years of age
* Patients with positive serology suggestive of celiac disease and/or biopsy-proven celiac disease and/or Human leukocyte antigen (HLA) DQ2 or DQ8 positivity.
* Patients with a diagnosis of inflammatory bowel disease
* Patients with a diagnosis of acute gastroenteritis
* Patients who are pregnant
* Type 1 Diabetes Mellitus

Exclusion criteria (healthy controls):

* NCGS
* Celiac disease
* Inflammatory bowel disease
* Irritable bowel syndrome
* Acute gastroenteritis
* Patients who are pregnant
* Type 1 Diabetes Mellitus

Primary outcomes:
measure: Patient estimated gluten intake after administration of gluten compared to baseline level on GFD, using the Celiac Dietary Adherence Test (CDAT)
timeFrame: 12 weeks
measure: NCGS symptoms, using the Celiac Symptom Index (CSI)10 after administration of gluten compared to baseline level on GFD
timeFrame: 12 weeks
measure: Stool gluten immunogenic peptides (GIP) level after administration of gluten compared to baseline level on GFD.
timeFrame: 12 weeks
measure: Urine gluten immunogenic peptides (GIP) level after administration of gluten compared to baseline level on GFD
timeFrame: 12 weeks
measure: Patient Estimation of Gluten Intake captured via (PEGI) questionnaire
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03675997: GRAFted Patients' anxieTY Report
Official title: GRAFted Patients' anxieTY Report (GRAFTY)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autologous Transplant Indication
Keywords: Autograft
Anxiety
Protected environment
Lead sponsor: Institut de Cancérologie de la Loire
Sponsor class: OTHER
First posted: 2018-09-18
Enrollment: 30
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 hospitalized for autograft will be eligible.

Brief summary: Autograft is a technique requiring several weeks of hospitalization in a protected environment and can be a source of anxiety of different natures for patients. In this study, level of anxiety will be reported weekly throughout hospitalizations for autologous transplant, to detect the most stressful period.

Detailed description: Autograft is one of hematological malignancies treatment, such as lymphoma and myeloma. This technique requires several weeks of hospitalization in a protected environment and can be a source of anxiety of different natures for patients. According to the medical and scientific report of the Biomedicine Agency in 2016, 3 043 patients were involved in an autologous transplant, which represents a significant number of patients potentially exposed to these types of anxiety.

That is why it will be interesting in this study to report weekly the level of anxiety throughout their hospitalization for the autologous transplant, to detect the most stressful period.

A validated questionnaire will be used: the HAD (Hospital Anxiety and Depression) scale of anxiety and depression.

Eligibility criteria: Inclusion Criteria:

* Autograft indication according to the Multidisciplinary Concertation Meeting

Exclusion Criteria:

* Incapacity to complete surveys

Primary outcomes:
measure: Anxiety and depression measure
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Priest-en-Jarez
country: France
facility: Institut de Cancérologie Lucien Neuwirth
Study officials:
affiliation: Institut de Cancérologie Lucien Neuwirth
name: Stéphanie Morisson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06615297: Mimic Muscle Volume, Central Facial Palsy Severity and Dysphagia
Official title: Demonstration of the Relationship Between Mimic Muscle Volume and Central Facial Palsy Severity and Dysphagia
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Facial Paralysis, Central
Stroke
Lead sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-09-26
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 70 stroke patients with central facial paralysis who were included in the rehabilitation program at Istanbul Physical Therapy and Rehabilitation Training and Research Hospital will be included

Brief summary: 70 stroke patients with central facial paralysis will be included and their demographic data will be questioned and facial nerve thickness, depressor labi inferior, depressor anguli oris, buccinator and risorius muscles will be evaluated.

Detailed description: 70 stroke patients with central facial paralysis who were included in the rehabilitation program at Istanbul Physical Therapy and Rehabilitation Training and Research Hospital will be included and their demographic data such as age, gender, marital status, education level, body mass index, stroke etiologies will be questioned and used with the House-Brackmann scale. Involvement levels, facial nerve thickness (right/left), depressor labi inferior, depressor anguli oris, buccinator and risorius muscles will be evaluated. The data obtained will be correlated with total dysphagia score and facial disability index.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of stroke and presence of unilateral central facial paralysis,
* Agreeing to participate in the study,
* Cognitive competence to understand the test instructions,
* Presence of communication skills to respond to the test instructions.

Exclusion Criteria:

* Presence of previous facial paralysis or a neurological disease other than stroke that will cause central paralysis,
* bilateral involvement
* illiteracy, refusal to participate in the study,
* jaw joint problem,
* surgical intervention in the facial area that will affect ultrasound measurements,
* infected open wound.

Primary outcomes:
measure: facial nerve thickness
timeFrame: baseline
Secondary outcomes:
measure: depressor labi inferior
timeFrame: baseline
measure: depressor anguli oris
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
References: