louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01427231: Short-term Effect of Glucose and Sacharose Ingestion on Cognitive Performance and Mood in Elderly
Official title: The Short-term Effect of Glucose and Sacharose Ingestion on Cognitive Performance and Mood in Elderly Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health
Cognition
Memory
Attention
Keywords: Cognitive performance
Attention
Memory
Glucose
Sacharose
Elderly
Memory complaints
Lead sponsor: Wageningen University
Sponsor class: OTHER
Collaborators: name: Suikerstichting Nederland (Baarn)
First posted: 2011-09-01
Enrollment: 43
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The objective of the current study is to determine the acute effect of a glucose drink and a sacharose drink compared to a placebo on cognitive performance in elderly with light memory complaints. The investigators expect that the sugar containing drinks will improve memory and attentional functions. Furthermore, blood glucose response will be measured.


Eligibility criteria: Inclusion Criteria:

* Men and women
* 70 years and older
* Memory complaints

Exclusion Criteria:

* Type I or II diabetes
* Parkinson disease
* MMSE \< 25 (to exclude cognitively impaired subjects
* CES-D \> 16 (to exclude depressive subjects)
* Pharmacological antidepressives or medication for dementia
* Liver disease

Primary outcomes:
measure: Performance on the paired associate recall test
timeFrame: cognitive tests will start 15 minutes after ingestion of the intervention product
Secondary outcomes:
measure: Mood
timeFrame: within 15 minutes after consuming the test drink and after completing the cognitive tests (within 90 minutes after consuming the test drink)
measure: Blood glucose response
timeFrame: from baseline till 90 minutes after consuming the drink
measure: Plasma insulin levels
timeFrame: At t= -15 minutes, before consuming the test drink
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Wageningen University
state: Gelderland
Study officials:
References:
Clinical trial NCT03078231: Pilot Assessment of EyeArt as an Automated Diabetic Retinopathy Screening Tool
Official title: Pilot Assessment of EyeArt as an Automated Diabetic Retinopathy Screening Tool
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Retinopathy
Lead sponsor: Eyenuk, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Eye Institute (NEI)
First posted: 2017-03-13
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study subjects will be enrolled at a primary care center

Brief summary: More than 29 million people in the US are living with diabetes, many of whom will develop diabetic retinopathy (DR) or diabetic eye disease (DED), the leading cause of vision loss and blindness in working-age adults. Annual eye screening is recommended for all diabetic patients since vision loss can be prevented with laser photocoagulation and anti-VEGF injections if DR is diagnosed in its early stages. Currently, the number of clinical personnel trained for DR screening is orders of magnitude smaller than that needed to screen the large, growing diabetic population. Therefore, to meet this large unmet need for DR screening, a fully-automated computerized DR screening system is necessary. This study is designed to assess the performance of EyeArt, an automated DR screening tool.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older;
* a diagnosis of diabetes mellitus; and
* understanding of study and provision of written informed consent.

Exclusion Criteria:

* Persistent visual impairment or sudden vision loss in one or both eyes;
* History of uncorrected media opacity in one or both eyes;
* History of retinal vascular disease other than diabetic eye disease;
* History of ocular injections, laser treatment of the retina, or intraocular surgery other than cataract;
* Subject has contraindications for mydriatic medications or is unwilling or unable to dilate;
* Subject is currently enrolled in an interventional study of an investigational device/drug; or
* Subject has a condition or is in a situation which in the opinion of the Investigator, might confound study results, may interfere significantly with the subject's participation in the study, or result in ungradable 4-wide field stereoscopic mydriatic fundus photographs.

Primary outcomes:
measure: Number of subjects whose EyeArt results match the reading center grading for identifying referable diabetic eye disease (moderate NPDR or higher on the ICDR scale or surrogate markers for CSME).
timeFrame: 1 visit
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: LAC+USC Medical Center
state: California
Study officials:
References:
Clinical trial NCT00389831: Efficacy, Safety and Tolerability of Rotigotine Nasal Spray for the Acute Treatment of RLS Symptoms
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Proof-of-concept Trial to Assess the Efficacy, Safety and Tolerability of Ascending Doses of Rotigotine Nasal Spray for the Acute Treatment of RLS Symptoms in Subjects With Idiopathic Restless Legs Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Restless Legs Syndrome
Keywords: Rotigotine
Rotigotine nasal spray
Efficacy, safety and tolerability
Restless Legs Syndrome
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2006-10-19
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of this phase 2a proof-of-concept trial is to assess the efficacy of rotigotine nasal spray in ascending doses in subjects with idiopathic Restless Legs Syndrome.

Detailed description: Each patient of the placebo and rotigotine group performed an Eligibility Assessment, as well 4 treatment days at which subjects performed a repeated 'Suggested Immobilization Test' (SIT) during a 30min pre-dose and a 4 hours post-dose period. During these periods the severity of RLS symptoms in the legs was assessed by the subject using a numeric symptom severity scale.

In addition the leg movements were measured by actigraphy to assess the Periodic Leg Movement Index during Wakefulness (PLMWI, PLM per hour). Subjects applied a single dose of treatment on each treatment day (placebo nasal spray or rotigotine nasal spray in 3 ascending doses).

Eligibility criteria: Inclusion Criteria:

* Subjects with idiopathic RLS, who are responding to an ongoing L-dopa treatment

Exclusion Criteria:

* Patients with secondary RLS or clinically relevant concomitant diseases or medical conditions are excluded

Primary outcomes:
measure: Average Numeric Symptom Severity Score After Single Dose of Rotigotine Nasal Spray or Matching Placebo
timeFrame: 4 hours post-treatment period at each treatment day
measure: Average PLMWI (Periodic Leg Movement Index During Wakefulness) After Single Dose of Rotigotine Nasal Spray or Matching Placebo.
timeFrame: 4 hours post-treatment period at each treatment day
Secondary outcomes:
Other outcomes:
Locations:
city: Monheim
country: Germany
facility: Schwarz BioSciences GmbH
Study officials:
affiliation: Schwarz BioSciences GmbH
name: Marianne Raetz
role: STUDY_DIRECTOR
References:
Clinical trial NCT06527131: Pulsed Electromagnetic Field Stimulation and Charcot Foot Ulcer
Official title: Pulsed Electromagnetic Field Stimulation and Charcot Foot Ulcer: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Charcot Foot Ulcer
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-07-30
Enrollment: 34
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: thirty-four patients with charcot foot ulcer will be included, their ages will be ranged from 50 to 70 years old and randomly distributed into two equal groups : study group includes 17 patients who will recieve pulsed electromagnetic field and electrical stimulation three days per week for three months .

control group includes 17 patients who will recieve electrical stimulation , standard wound care and medical treatment


Eligibility criteria: Inclusion Criteria:

* age ranges between 50 and 70 years old male and female patients all patients with charcot foot ulcer

Exclusion Criteria:

* presence of malignancy hypotensive patients pregnancy immunological and rheumatological disorders

Primary outcomes:
measure: rate of bone healing
timeFrame: Baseline and three months
Secondary outcomes:
measure: ulcrer healing
timeFrame: baseline and three months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Physical Therapy Cairo University
Study officials:
References:
Clinical trial NCT04643431: Risk Assessment of Carotid Plaques Using 3D Contrast-Enhanced Ultrasound
Official title: Risk Assessment of Carotid Plaques Based on Pressure Estimation Using 3D Contrast-enhanced Ultrasound
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Carotid Atherosclerosis
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2020-11-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is an open-label, non-randomized study conducted at Thomas Jefferson University comparing pressure-gradient estimates (obtained between a carotid plaque and the carotid artery) to imaging and histology markers of plaque vulnerability. There is an inverse relationship between the subharmonic signal magnitude from contrast-enhanced ultrasound microbubbles and ambient pressure. This pressure estimation technique (referred as SHAPE) will be used to estimate the pressure gradient across the carotid plaque cap noninvasively in vivo.


Eligibility criteria: Inclusion Criteria:

* Patients \>18 years old and willing and able to participate. Patients with atherosclerosis scheduled for carotid endarterectomy

Exclusion Criteria:

* • Pregnancy or breast-feeding at the time of the scan

  * Patients with known hypersensitivity or allergy to any component (including perflutren) of Definity (Lantheus Medical Imaging, Billerica, MA).
  * Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. For example:

    * Patients on life support or in a critical care unit.
    * Patients with unstable occlusive disease (e.g., crescendo angina).
    * Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia.
    * Patients with uncontrolled congestive heart failure (NYHA Class IV).
    * Patients with recent cerebral hemorrhage.
    * Patients who have undergone surgery within 24 hours prior to the study sonographic examination.
  * Patients with unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias) or respiratory distress syndrome.
  * Patients with uncontrollable emphysema, pulmonary vasculitis, pulmonary hypertension or a history of pulmonary emboli.
  * Patients who have received any contrast medium (X-ray, MRI, CT or ultrasound) in the 24 hours prior to the research ultrasound exam

Primary outcomes:
measure: Correlation between the pressure gradient and surrogate (imaging and histological) predictors
timeFrame: pre-endarterectomy
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Kibo Nam, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04726631: Insulin in Treatment of Diabetes Mellitus With Pregnancy
Official title: Insulin Analogue Versus Conventional Premixed Insulin in the Treatment of Diabetes Mellitus With Pregnancy: A Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-01-27
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The prevalence of diabetes melilites is rapidly increasing over years and consequently during pregnancy. In 2017, there were 21.3 million pregnant women who experienced hyperglycemia, of which 86.4% of them were diagnosed with gestational diabetes melilites.

Pregnancy in women with diabetes is associated with an intensification in adverse maternal, fetal and perinatal outcomes including spontaneous abortions, congenital malformations, preterm labor, and macrosomia. Several studies have confirmed that poor glycemic control in women with either gestational, type 1 or type 2 diabetes during pregnancy is associated with poor pregnancy outcomes. In the same line, proper glycemic control before, early, and through all pregnancy markedly improves both maternal and fetal outcomes.

Insulin therapy is the standard treatment of diabetes melilites with the pregnancy if dietary control and exercise fail. However, insulin therapy has its difficulties like approaches to mimicking postprandial insulin release, providing adequate background insulin, balancing insulin dosage, food, activity, hypoglycemic episodes, overall glycemia. This is always a struggle for doctors and patients and much affecting their lifestyle


Eligibility criteria: Inclusion Criteria:

* Age of 18 - 45 years old,
* Women with pre-gestational diabetes.
* Those who were under premixed insulin therapy prior to pregnancy.
* women pregnant between 14 weeks up to 28 weeks of gestation

Exclusion Criteria:

* History of recurrent miscarriage
* multiple pregnancies
* chronic hypertension
* severe heart, liver, and kidney disease.
* women how got pregnant after assisted reproduction
* those with advanced retinopathy, hypersensitivity to insulin.
* Women who developed bleeding in early pregnancy and those diagnosed to have any major anomaly during the first-trimester scan.

Primary outcomes:
measure: the percentage of maternal glycosylated Hemoglobin
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03036631: Ideal Sedation for Stroke Thrombectomy
Official title: Ideal Sedation for Stroke Thrombectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Stroke
Lead sponsor: Neurovascular Research Foundation
Sponsor class: OTHER
First posted: 2017-01-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients underwent mechanical thrombectomy at Los Robles hospital, Thousand Oaks, CA

Brief summary: The Ideal Sedation for Stroke Thrombectomy (ISST) registry will answer the key questions whether sedation with intubation and paralytics is feasible and whether it delays the time to recanalization in comparison with conscious sedation alone. As a pilot registry, it is anticipated to enroll 40 acute stroke patients requiring mechanical thrombectomy over 12-18 months. Following enrollment, data will be collected prospectively from medical records and from patients' visits.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Suitable for intra-arterial treatment for acute stroke up to 8 hours from onset of symptoms
* Clinical equipoise for best mode of sedation

Exclusion Criteria:

* Any known allergy to either proposed medication and its alternative
* Any patient that has been intubated prior to randomization
* Posterior circulation strokes
* Age ≤ 18
* Pregnant female

Primary outcomes:
measure: Time interval between groin puncture and final recanalization
timeFrame: 6 months or at study completion
Secondary outcomes:
Other outcomes:
Locations:
city: Thousand Oaks
country: United States
facility: Los Robles Hospital and Medical Center
state: California
Study officials:
affiliation: Neurovascular Research Foundation
name: Muhammad A Taqi
role: PRINCIPAL_INVESTIGATOR
References:
citation: Taqi MA, Suriya SS, Sodhi A, Quadri SA, Farooqui M, Zafar A, Mortazavi MM. Ideal sedation for stroke thrombectomy: a prospective pilot single-center observational study. Neurosurg Focus. 2019 Feb 1;46(2):E16. doi: 10.3171/2018.11.FOCUS18522.
Clinical trial NCT06896331: Inside a Neuron - Ex Vivo Evaluation of Cerebral and Cerebellar Neuronal Activity.
Official title: Inside a Neuron - Ex Vivo Evaluation of Cerebral and Cerebellar Neuronal Activity Through Electrophysiological and Imaging Techniques on Human Tissue from Surgical Activity.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Human Neural Cells Functioning
Keywords: INSANE, neurons, human, glioma, brain, patch-clamp, HD-MEA
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2025-03-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a brain/cerebellum primary or secondary tumor.

Brief summary: Understanding the functioning of human neurons has always been a key element, especially with regard to the translation of the inputs they receive into actions that determine human behavior. However, the vast majority of studies have been performed in animal models due to the difficulty in maintaining neuronal functions ex vivo. Recently, techniques have been illustrated that allow us to obtain slices of brain tissue removed during neurosurgical interventions. The patch-clamp and HD-MEA (high density - microelectrodes array) techniques, used until now for animal samples, can allow us to study the functioning of the neural cells that make up these slices. Furthermore, the exploration of the functioning of the aforementioned cells in pathological conditions can open the field for further therapeutic perspectives.


Eligibility criteria: Inclusion Criteria:

* patients with a brain/cerebellum primary or secondary tumor for whom at least partial resection has been planned.

Exclusion Criteria:

* patients with a brain/cerebellum primary or secondary tumor for whom a biopsy has been planned

Primary outcomes:
measure: Primary endpoint
timeFrame: Through study completion, an average of 3 years.
Secondary outcomes:
measure: Secondary endpoint
timeFrame: Through study completion, an average of 3 years.
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo di Pavia
Study officials:
References:
Clinical trial NCT00358631: An Eight-Week Study Evaluating the Efficacy and Tolerability of Two Doses of SSR149415 in Outpatients With Major Depressive Disorder
Official title: An Eight-Week, Multicenter, Double-Blind, Placebo- and Escitalopram-Controlled Study Evaluating the Efficacy and Tolerability of Two Fixed Doses of SSR149415 (250 mg Bid and 100 mg Bid) in Outpatients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depressive Disorder
Keywords: depression
antidepressive agents
controlled clinical trial
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-08-01
Enrollment: 319
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective is to evaluate the efficacy and safety of two doses of SSR149415 (250 mg and 100 mg twice daily) compared to placebo and escitalopram 10 mg once daily in outpatients with major depressive disorder.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of major depressive disorder, as defined by DSM-IV criteria and confirmed by the semi-structured MINI, recurrent episode.

Exclusion Criteria:

* Total score of less than 24 on the MADRS.
* HAM-D total score less than 18.
* Duration of the current depressive episode less than 1 month or greater than 2 years.
* Patients with a history or presence of bipolar disorders or psychotic disorders.
* Patients with alcohol dependence or abuse or substance dependence or abuse in the past 12 months except nicotine or caffeine dependence.
* Patients who have used the following prior to entry into Acute Phase: antipsychotics within 3 months, fluoxetine within 1 month, MAOIs within 2 weeks, other antidepressants, anxiolytics, or mood-stabilizer (lithium, anticonvulsants) within 1 week except as allowed in the protocol.

The investigator will evaluate whether there are other reasons why a patient may not participate

Primary outcomes:
measure: The primary efficacy endpoint is the change from baseline to Day 56 in the 17-item Hamilton Depression Rating Scale (HAM-D) total score.
Secondary outcomes:
measure: The main secondary endpoints are the changes from baseline to Day 56 in the HAM-D depressed mood item, Montgomery-Asberg Depression Rating Scale (MADRS) total, and Clinical Global Impression (CGI) Severity of Illness scores.
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis
state: New Jersey
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References:
citation: Griebel G, Beeske S, Stahl SM. The vasopressin V(1b) receptor antagonist SSR149415 in the treatment of major depressive and generalized anxiety disorders: results from 4 randomized, double-blind, placebo-controlled studies. J Clin Psychiatry. 2012 Nov;73(11):1403-11. doi: 10.4088/JCP.12m07804. Epub 2012 Oct 16.