louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00958165: Clinical Study of the CardioFocus Endoscopic Ablation System for the Treatment of Symptomatic AF
Official title: Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (CFEAS- AC) for the Treatment of Symptomatic Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Paroxysmal Atrial Fibrillation
Keywords: Treatment of PAF using EAS-AC
Lead sponsor: CardioFocus
Sponsor class: INDUSTRY
First posted: 2009-08-13
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and effectiveness of the endoscopic ablation system - adaptive contact (EAS-AC) in treated paroxysmal atrial fibrillation (PAF) with pulmonary vein isolation (PVI).


Eligibility criteria: Inclusion Criteria:

* Symptomatic, Paroxysmal atrial fibrillation (AF)
* 18 to 70 years of age
* Failure of at least one AAD
* Others

Exclusion Criteria:

* Generally good overall health as determined by multiple criteria
* Willing to participate in a study
* Others

Primary outcomes:
measure: Chronic Effectiveness in Treating PAF as Demonstrated by no AF Recurrences After the Blanking Period and During the 12-month Follow-up Period.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurg
country: Germany
facility: Cardioangiologisches Centrum Bethanien - CCB
city: Hamburg
country: Germany
facility: St. Georg Hosptial
city: Leipzig
country: Germany
facility: Universität Leipzig - Herzzentrum
Study officials:
References:
Clinical trial NCT00464165: Comparison of Efficacy and Safety of Rimonabant 5mg/Day or 20mg/Day Versus Placebo in Smoking Cessation
Official title: Comparison of the Efficacy and Safety of 2 Oral Doses of Rimonabant, 5mg/Day or 20mg/Day, Versus Placebo, as an Aid to Smoking Cessation; Multiple Country, Randomized, Double-blind, 3-arm, 10-week Treatment, 40-week Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Smoking Cessation
Keywords: abstinence
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-04-23
Enrollment: 789
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: The primary objective is to assess the efficacy of 2 fixed doses of rimonabant versus placebo on abstinence from tobacco use in cigarette smokers.

The secondary objective is to evaluate the effects of rimonabant on craving and weight and on the clinical and biological safety and tolerability of rimonabant in a population of cigarette tobacco smokers during a 10-week treatment period and to observe the percentage of abstinent subjects during a 40-week follow-up post treatment.


Eligibility criteria: Inclusion Criteria:

* Smokers smoking at least 10 cigarettes/day as a mean within the 2 months preceding the screening visit
* Motivated to quit with a score greater than or equal to 6 on the ten-point Motivation Scale

Exclusion Criteria:

* Non tobacco cigarettes consumption
* Chronic use of marijuana
* Pregnancy, breastfeeding
* Any clinically significant disease that might interfere with the efficacy or safety evaluation of the study drug
* Concomitant use of drugs as an aid to smoking cessation or that might induce weight change

Primary outcomes:
measure: Prolonged abstinence from smoking during the last 4 weeks of treatment reported by the subject and confirmed by exhaled carbon monoxide (CO) and cotinine measurements
Secondary outcomes:
measure: Efficacy: mean change of the total score of Questionnaire on Smoking Urges (QSU) brief scale, categorical change in body weight in subjects with Body Mass Index lower than 30 kg/m² at baseline who achieve prolonged abstinence
measure: Safety data
Other outcomes:
Locations:
city: Diegem
country: Belgium
facility: Sanofi-Aventis Administrative Office
city: Horsholm
country: Denmark
facility: Sanofi-Aventis Administrative Office
city: Paris
country: France
facility: Sanofi-Aventis Administrative Office
city: Barcelona
country: Spain
facility: Sanofi-Aventis Administrative Office
city: Bromma
country: Sweden
facility: Sanofi-Aventis Administrative Office
city: Geneva
country: Switzerland
facility: Sanofi-Aventis Administrative Office
city: Guildford
country: United Kingdom
facility: Sanofi-Aventis Administrative Office
state: Surrey
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
Clinical trial NCT03556865: Knowledge, Attitude, And Practice In A Group Of Egyptian Dentists Towards Preventive Measures In Pediatric Dentistry: A Cross-Sectional Study
Official title: Knowledge, Attitude, And Practice In A Group Of Egyptian Dentists Towards Preventive Measures In Pediatric Dentistry: A Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dental Caries
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-06-14
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Egyptian dentists working in either Faculty of Dentistry Cairo University or Police Academy Hospital and postgraduate students at Faculty if Dentistry - Cairo University

Brief summary: The study will include general dental practitioners or dental specialists from Police Academy Hospital and pediatric dentists from Pediatric dentistry department at Faculty of Dentistry Cairo University.

A self-administered questionnaire will be given to dentists by direct interviewing and they will be allowed to complete the questionnaire in Faculty of Dentistry, Cairo University or Police Academy Hospital. The data will be based on a collection of responses to the 38 items in the questionnaire.


Eligibility criteria: Inclusion Criteria:

* Egyptian dentists working in either Faculty of Dentistry Cairo University or Police Academy Hospital.
* Postgraduate students.

Exclusion Criteria:

* Refusal to participate in the study

Primary outcomes:
measure: Knowledge,attitude and practice towards preventive measures in pediatric dentistry.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06349265: Ultrasound-Guided 5% Dextrose Injection for Carpal Tunnel Syndrome
Official title: A Comparative Analysis of the Efficacy of Ultrasound-Guided Injection of 5% Dextrose in Water for the Treatment of Mild to Severe Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Carpal Tunnel Syndrome
Keywords: dextrose
carpal tunnel syndrome
ultrasound
Lead sponsor: Kastamonu University
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 33
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was a prospective randomized double-blind clinical trial conducted at the Physical Medicine and Rehabilitation Clinic of a local research and training hospital in Turkey from October 2023 and May 2024. Patients diagnosed with CTS were classified into three groups: severe, mild, and moderate CTS, based on the results of electrophysiological tests. An ultrasound-guided 5% Dextrose in Water injection was performed. The primary outcome measurement was the Visual Analog Scale (VAS), while secondary measurements were the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) and the Dolour Neuropathic en 4 Questions (DN4) questionnaire. The measurements were performed before the injection and at the first week, first month and third month follow-up times. The distribution of data within groups was examined using the Shapiro-Wilk test and Q-Q plots. The study also analyzed temporal changes, group differences, and intergroup changes using repeated measures ANOVA models.


Eligibility criteria: Inclusion Criteria:

1. Paresthesia/dysesthesia, painful swelling with clumsy weakness of the hand exacerbated by sleep or repetitive use of the wrist, and relieved by shaking the hand with postural change.
2. Sensory loss with numbness in the median nerve-innervated regions of the hand.
3. Weakness with atrophy of the median nerve-innervated thenar muscles.
4. Positive Phalen's test and/or Tinel's sign.
5. The diagnosis should be confirmed with electrodiagnostic studies.

Exclusion Criteria:

1. History of cervical myelomalacia, polyneuropathy, brachial plexopathy, or thoracic outlet syndrome.
2. History of systematic infection, and rheumatologic disorders.
3. Previous steroid injection for carpal tunnel syndrome.

Primary outcomes:
measure: Visual Analogue Scale(VAS)
timeFrame: At the beginning, 1.,4., 12. week
Secondary outcomes:
measure: Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)
timeFrame: At the beginning, 1.,4., 12. week
measure: Dolour Neuropathique en 4 Questions (DN4) questionnaire
timeFrame: At the beginning, 1.,4., 12. week
Other outcomes:
Locations:
city: Kastamonu
country: Turkey
facility: Gamze Gül Güleç
Study officials:
affiliation: İstanbul Physical Medicine and Rehabilitation Hospital
name: Emre Özmen
role: STUDY_CHAIR
References:
Clinical trial NCT04786665: Strawberries, Cognition, and Vascular Health
Official title: Impact of Strawberries on Cognition, and Vascular and Cardiometabolic Markers in Older Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Healthy Aging
Keywords: Cognition
Motor control
Vascular health
Lead sponsor: San Diego State University
Sponsor class: OTHER
First posted: 2021-03-08
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Using a randomized crossover study design, the effects will be compared to the effects of 8 wk intake of a placebo drink-mix (with a 4 wk wash-out period between trials).
Primary purpose: OTHER

Brief summary: The primary objective of this study is to investigate the effects of strawberries on cognitive responses, motor control function, and vascular and cardiometabolic risk markers in healthy older adults.

Detailed description: To achieve the objectives, 40 healthy men and women ≥65 years of age will consume 26 g of freeze-dried strawberries in the form of a drink-mix daily for 8 wk. Using a randomized crossover study design, the effects will be compared to the effects of 8 wk intake of a placebo drink-mix (with a 4 wk wash-out period between trials). Cognitive function measurements will be performed at baseline and 8 wk. Additionally, at each timepoint, flow-mediated vasodilation and blood pressure will be measured followed by collection of fasting blood samples to assess glucose, insulin, blood lipids (free fatty acids, triacylglycerol, total cholesterol, LDL cholesterol, and HDL cholesterol), inflammatory markers (interleukins 6 and 18), and markers of oxidative stress (oxidized LDL-C and malondialdehyde).

Eligibility criteria: Inclusion Criteria:

* Healthy men and women 65 years and older

Exclusion Criteria:

* stroke or myocardial infarction
* neurological disorders:
* epilepsy,
* multiple sclerosis,
* Parkinson's disease,
* stroke
* known metabolic disorders:
* liver,
* renal
* clinically diagnosed diabetes
* drug treatment for lipid reduction or hypertension,
* psychiatric medication use

Primary outcomes:
measure: Change from baseline in processing speed (cognition) at 8 weeks
timeFrame: At baseline, at 8 weeks
measure: Change from baseline in executive function (cognition) at 8 weeks
timeFrame: At baseline, at 8 weeks
measure: Change from baseline in working memory (cognition) at 8 weeks
timeFrame: At baseline, at 8 weeks
measure: Change from baseline in episodic memory (cognition) at 8 weeks
timeFrame: At baseline, at 8 weeks
measure: Change from baseline in working memory (cognition) at 8 weeks
timeFrame: At baseline, at 8 weeks
Secondary outcomes:
measure: Change from baseline in Vascular health at 8 weeks
timeFrame: At baseline, at 8 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Shirin Hooshmand
state: California
Study officials:
References:
Clinical trial NCT06194565: 99mTc-ABH2 SPECT/CT in Breast Cancer
Official title: Molecular Imaging of HER2 Expression in Breast Cancer Using 99mTc-ABH2 SPECT/CT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2024-01-08
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This prospective study will investigate the potential usefulness of 99mTc-ABH2 SPECT/CT in the diagnostic performance and evaluation efficacy of breast cancer.

Detailed description: This study aims to assess the diagnostic performance of 99mTc-ABH2 SPECT/CT for the detection of HER2-positive primary breast cancer and possible metastases. Visual and semiquantitative methods will be utilized to evaluate the acquired SPECT/CT images. A comparative analysis of tumor imaging data and HER2 expression obtained by immunohistochemistry (IHC) and/or fluorescent in situ hybridization (FISH) analysis of biopsy samples will further be conducted. Results of HER2 expression imaging may have potential significance in screening and monitoring individuals for targeted therapy with monoclonal antibodies, like Trastuzumab.

Eligibility criteria: Inclusion Criteria:

* clinically suspected primary breast cancer by mammography or ultrasonography and being able to sign the written informed consent form

Exclusion Criteria:

* pregnancy or lactation, impaired liver or kidney failure, and undergoing any preceding local or systemic therapies that might interfere HER2 binding

Primary outcomes:
measure: SPECT/CT-based 99mTc-ABH2 uptake value in tumor lesions
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Hongli MD Jing
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03953365: Prophylactic Mesh in Cytoreductive Surgery
Official title: Prevention of Incisional Hernia With Prophylactic Mesh in Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy. A Multicentre, Prospective, Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Incisional Hernia
Keywords: hyperthermic intraperitoneal chemotherapy
cytoreduction surgery
prophylactic mesh
Lead sponsor: Hospital Universitario Fundación Alcorcón
Sponsor class: OTHER
First posted: 2019-05-16
Enrollment: 66
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: PREVENTION

Brief summary: Evaluate the effectiveness of mesh reinforcement in high-risk patients to prevent incisional hernia.

Detailed description: Based on the hypothesis that oncological cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy (HIPEC) is associated with an increased risk of developing Incisional Hernia in the postoperative period, with an expected incidence of 50% at 24 months, we designed a prospective, multicenter and randomized clinical study to demonstrate the utility of the meshes in the prevention of Incisional Hernia, hoping to reduce the incidence to 15% at 24 months.

Eligibility criteria: Inclusion Criteria:

* Completeness of cytoreduction after surgery (CC-SCORE) CC-0, CC-1

Exclusion Criteria:

* Completeness of cytoreduction after surgery (CC-SCORE) CC-2, CC-3

Primary outcomes:
measure: Rate of Incisional Hernia
timeFrame: four years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04465565: Fluids Administration During Combined Clonidine-Arginine Growth Hormone Stimulation Test
Official title: Fluids Administration During Combined Clonidine-Arginine Growth Hormone Stimulation Test- Randomized, 2 Arms, Controlled Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Growth Hormone Deficiency
Keywords: Growth Hormone stimulation tests
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2020-07-10
Enrollment: 0
Sex: ALL
Minimum age (years): 7
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, 2 arms, controlled study
Primary purpose: SUPPORTIVE_CARE

Brief summary: The diagnosis of Growth Hormone deficiency in childhood requires the performance of an artificial pharmacological stimulation tests. There are number of substances that increase the secretion of growth hormone, among them Clonidine and Arginine. One of the possible side effects of both Clonidine and Arginine is a reduction in the blood pressure due to a decreased heart output and declined contraction of peripheral blood vessels. In cases where values of blood pressure at the end of the test are not recovered after two sessions of 15 minutes of physical activity, the patient is treated with I. V of 9%NORMAL SALINE (0. 20cc /Kg) administrated over 30-60 minutes.

The aim of the proposed study is to test whether administration of fluids during the combined Growth Hormone stimulation test Clonidine-Arginine will help in the recovery process from the test (blood pressure \> 90/50 mmHg after performing physical activity defined as 15-minutes hike in two consecutive sessions). The study design will be randomized, controlled, 2 arms study.


Eligibility criteria: Inclusion Criteria:

* Children referred to combined Arginine- Conidine Growth Hormone stimulation test
* Girls: 7-14 years old and Boys: 7-16 years old
* Weight\>20 kg
* Normal thyroid function

Exclusion Criteria:

* BMI over percentile 85
* Genetic syndromes or chromosomal disorders
* Steroid treatment
* Renal failure
* Heart failure

Primary outcomes:
measure: Average blood pressure
timeFrame: Time 180 mnutes- at time of discharging the participant
Secondary outcomes:
measure: Average blood pressure
timeFrame: Time 0- prior to initiating the Growth Hormone test
measure: Average blood pressure
timeFrame: Time 90 minutes after completing the Arginine adminstration
measure: Average blood pressure
timeFrame: Time 150 minutes after completing the Arginine adminstration
measure: Time elapsed between completing the Growth Hormone test until participant is allowed to go home
timeFrame: Time 180 minutes-at time of discharging the participant (after measuring blood pressure > 50/90mm/Hg)
Other outcomes:
Locations:
city: Petach-Tikva
country: Israel
facility: Schneider Children's Medical Center of Israel
Study officials:
affiliation: Schneider Children's Medical Center, Israel
name: Moshe Phillip, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01108965: Study of Shunt Flow Sensor Accuracy in Extra-ventricular Drains.
Official title: A Flow Monitor for Pediatric Hydrocephalic Shunts
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hydrocephalus
Nervous System Diseases
Infant, Newborn Diseases
Keywords: Hydrocephalus
Shunt Dysfunction
Shunt Flow
Lead sponsor: Transonic Systems Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2010-04-22
Enrollment: 16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hydrocephalus patients under the care of SUNY Upstate Medical University

Brief summary: The study hypothesis is that an ultrasonic flow sensor can accurately measure flow in hydrocephalic shunts.

The ultrasonic sensor will measure cerebrospinal fluid drainage in hydrocephalus patients with external ventriculostomies and extra-ventricular drainage systems. The sensor measurements will be compared with the volume of fluid collected by the drainage bag.

After a 24-hour measurement period, the doctor will change the drainage bag position to simulate the patient sitting up and leaning back, to see if this temporarily stops flow through the drainage line.

This data will show whether the sensor accurately measures typical drainage flows seen in hydrocephalus patients. This research will help develop an implantable flow monitor for pediatric hydrocephalus patients.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with hydrocephalus
* Instrumented with an Extraventricular drainage system

Exclusion Criteria:

* Not diagnosed with hydrocephalus
* Not instrumented with an extraventricular drainage system

Primary outcomes:
measure: Volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage system.
timeFrame: 24 hour-period
Secondary outcomes:
measure: Recording of the pressure waveform related to the volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage system.
timeFrame: 24 hour period
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
Study officials:
affiliation: Transonic Systems Inc.
name: Cornelis J Drost
role: PRINCIPAL_INVESTIGATOR
affiliation: State University of New York - Upstate Medical University
name: Satish Krishnamurthy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05778565: Extraocular Muscle Stretching as a Weakening Procedure
Official title: Stretching of an Extraocular Rectus Muscle as a Weakening Procedure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Strabismus, Comitant
Lead sponsor: Universidad Autonoma de Madrid
Sponsor class: OTHER
First posted: 2023-03-21
Enrollment: 7
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Extraocular muscle procedure
Primary purpose: TREATMENT

Brief summary: Interventional case series. Non-operated patients with an indication of medial rectus muscle weakening surgery (deviation up to 20 PD) who could cooperate with topical or sub-Tenon's anesthesia. Clinical workup includes routine complete ophthalmological evaluation. One double needle 6/0 Mersilene suture is used on each side of the muscle at 4 mm distance of the insertion and pulled / stretched to insert in the sclera 3-5 mm posterior to the muscle locking passes.

Seven patients with esotropia of 12-20 PD were included.


Eligibility criteria: Inclusion Criteria:

* Patients requiring weakening of medial rectus muscle(s) for 12-20 PD of esotropia who could cooperate with topical / sub-Tenon's anesthesia, and had no previous eye muscle surgery

Exclusion Criteria:

* Patients with previous strabismus surgery

Primary outcomes:
measure: Distance deviation at 2 months after surgery
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: UAM
Study officials:
affiliation: Universite Abdou Moumouni de Niamey, Niger
name: Jaime Tejedor, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: