louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01033058: Intensive Statin Treatment for STEMI Patients Undergoing Primary PCI
Official title: Effect of Intensive Statin Treatment on 90-day Prognosis of STEMI Patients Undergoing Emergency Primary PCI Compared With Usual Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: STEMI
Keywords: STEMI
atorvastatin
PCI
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2009-12-16
Enrollment: 500
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a retrospective, randomized, parallel, open-labeled, controlled study to find out whether STEMI patients undergoing emergency PCI can benefit from intensive atorvastatin treatment compared with routine treatment.

Detailed description: ARMYDA-ACS, ARMYDA-RECAPTURE and NAPLES II demonstrated that in patients with ASP and NSTE ACS undergoing early PCI, loading dose of atorvastatin before early PCI led to a reduction of prei-PCI MI, recurrent CV events and mortality. While, theses studies included patients with non-ST-segment elevation ACS, requiring PCI; these results cannot be extrapolated directly to patients with ST-segment elevation MI, and these trials included patients sent to an early and selective PCI, but not those undergoing emergency revascularization;

This study is designed to find out whether STEMI patients undergoing emergency PCI can benefit from intensive atorvastatin treatment compared with routine treatment.

Eligibility criteria: Inclusion Criteria:

* 20-75 years old
* myocardiac ischemia symptom of index event appeared less than 12 hours before enrollment.
* ECG showed elevated ST segment in 3 or more contiguous leads
* diagnosed with acute STEMI
* eligible for primary PCI, and primary PCI is scheduled within 2 hours after enrollment

Exclusion Criteria:

* allergic or experienced serious adverse reaction to HMG-CoA reductase
* pregnancy, lactation, or child bearing potential women without any effective contraception
* accompanied with malignant disease
* active hepatic disease or hepatic dysfunction

Primary outcomes:
measure: The combined endpoint of 90-day all cause morality, cardiac death, recurrent MI, recurrent symptomatic myocardiac ischemia, target vessel revascularization
timeFrame: 2009 Dec- 2011 Mar
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chaoyang Hospital
state: Chaoyang
Study officials:
affiliation: Beijing Chaoyang Hospital, China
name: Xinchun Yang, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05696158: Mahana Tinnitus Pilot
Official title: A Prospective, Open-Label Trial of MHNA-003, a Smartphone-Delivered Cognitive Behavioral Therapy (CBT) Treatment, in Adults With Symptoms of Tinnitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus
Lead sponsor: Mahana Therapeutics
Sponsor class: INDUSTRY
First posted: 2023-01-25
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main objective of this prospective, open-label, non-significant risk study is to assess the efficacy and safety of Mahana™ Tinnitus together with care as usual in approximately 250 adults with symptoms of tinnitus.

Detailed description: Following informed consent, all participants will complete a series of screening questionnaires to determine eligibility for study entry. Eligible participants will be enrolled, and will receive access to MHNA-003 (Mahana™ Tinnitus). Participants will use MHNA-003 for 6 weeks, completing assessments at Baseline and Weeks 2, 4, and 6 following Baseline.

Eligibility criteria: Inclusion Criteria:

* Participant scores ≥ 25 on the Tinnitus Functional Index.
* Participant has experienced symptoms of tinnitus for at least 3 months.
* Participant is at least 18 years of age at the time of consent.
* Participant resides in the United States.
* Participant is able to speak, read, and understand English.
* Participant has access to an iOS or Android smartphone with the ability to complete study tasks.
* Participant is able to commit the time required to complete therapy modules and study assessments.

Exclusion Criteria:

* Participant scores ≥2 on item 9 (suicidal thoughts) of the Beck's Depression Index (BDI).
* Participant has been hospitalized for psychiatric reasons within 12 months of screening.
* Participant is currently enrolled in or plans to enroll in another clinical study that could impact outcomes of this trial.

Primary outcomes:
measure: Mean Change in TFI Score From Baseline to Week 6
timeFrame: 6 weeks
measure: Tinnitus Functional Index Responder Rate
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Mahana Therapeutics
state: California
Study officials:
References:
Clinical trial NCT03059758: Deductive Reasoning and Math Learning Difficulty
Official title: Deductive Reasoning and Math Learning Difficulty: an fMRI Study in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 137
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Most studies to date that have examined the factors underlying math achievement in children have focused on basic numerical knowledge. Yet, math skills are clearly not limited to basic numerical knowledge and recent behavioral studies suggest a relationship between math and deductive reasoning skills. The goal of this study is to determine the neural mediators of this relationship using functional magnetic resonance imaging. The investigators will ask children from 8 to 14 to complete a standardized math achievement test, and measure their brain activity while they process deductive arguments. The investigators will then correlate brain activity during reasoning to individual math skills to identify the brain regions in which activity during reasoning is modulated by math skill.


Eligibility criteria: Inclusion Criteria:

* Girl or boy between 8 and 14
* Right-handed
* Affiliated to the French social security
* Whose parents gave informed consent

Exclusion Criteria:

* Neurological disorders
* Psychiatric disorders
* Birth complications requiring admission into neonatal intensive care unit
* Medication affecting central nervous system processing
* Significant hearing impairment
* Uncorrected visual impairment
* Non-native French speaker
* Contraindications for MRI

Primary outcomes:
measure: Correlation between brain activity during deductive reasoning and math skill 18 to 24 months later
timeFrame: 18 to 24 months after scanning
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: CH le Vinatier
Study officials:
References:
Clinical trial NCT01858896: GLP-1 and Hypoglycemia
Official title: Hypoglycemia Associated Autonomic Dysfunction
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Type 2 Diabetes Mellitus
Keywords: hypoglycemia
GLP-1
Type 2 diabetes
endothelial function
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2013-05-21
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Low blood sugar can negatively affect how blood vessels function, and this can lead to an increase in the risk for heart attacks, strokes and other problems related to the stiffening and blockage of blood vessels. The purpose of this study is to learn if and how glucagon-like peptide-1 (GLP-1; a naturally occurring hormone in the gut) changes the effects that low blood sugar levels have on blood vessels.


Eligibility criteria: Inclusion Criteria:

* 14 (7 males, 7 females) healthy controls age 30-60 yr.
* 14 (7 males, 7 females) people with type 2 DM age 30-60 yr.
* For type 2 DM: HbA1c 6-10.0%
* No significant diabetic tissue complications (i.e. history of retinopathy, neuropathy, stasis ulcers, etc.)
* Body mass index \>25kg • m-2

Exclusion Criteria:

-

Primary outcomes:
measure: Change in Plasminogen Activation inhibitor-1 (PAi-1)
timeFrame: change from baseline to end of clamp period
measure: Change in Flow mediated dilation (FMD)
timeFrame: change from baseline and end of clamp
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland, Baltimore
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Stephen N Davis, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04721496: Experimental Study Measuring Power and Execution Speed in 44 Athletes in Push-up Exercise.
Official title: Measuring Velocity and Power on Unstable Push-up: Differences Between Trained and Untrained Population.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Power
Keywords: Core
Unstable Devices
Suspension Training
Resistance Training
Strength
Lead sponsor: Universidad Politecnica de Madrid
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 44
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Investigation of power and speed in relation to the increasing instability in a group of untrained athletes and a group of expert athletes. In this way, the effectiveness of unstable training for different types of athletes can be tested.

Our hypothesis is that as instability increases there is a gradual decrease in power and speed of execution, but not too relevant in the expert group.

Detailed description: Introduction

Strength training using devices that induce varying degrees of instability is widely practiced in numerous contexts and has been credited with benefits in prevention, rehabilitation and general health. Several studies have found a progressive decrease in power as the degree of instability increases. However, it is not known how mildly unstable situations are affected, nor are the differences between trained and untrained subjects.

The purpose of the present study was to compare the effect of different degrees of instability on power and speed of execution in a push-up or arm-bottoms exercise, in trained and untrained subjects.

Method

Maximum power (MP) and mean power (BP), and maximum speed (MV) and mean propulsive speed (VA) of push-up were analyzed in 44 subjects, 24 untrained (176.38±5.35 cm, 76.38±6.85 kg, 2.5±1.5 months experience) and 20 trained (178.45±5.91 cm, 83.4±21.56 kg, 15.5±5.3 months experience), under six conditions of increasing instability: 1) stable, 2) device in suspension: rings, 3) monopodal, 4) device in suspension: TRX®, 5) with hands-on Bosu® and 6) with hands-on TRX® and feet on Bosu®.

Eligibility criteria: Inclusion Criteria:

* 2 years of continuous strength training
* No injuries of any kind within the last year
* Perform a regular push-up exercise
* Having ever used an unstable device

Exclusion Criteria:

* Previous injuries
* Never have used unstable devices
* Newcomers to strength training

Primary outcomes:
measure: Power
timeFrame: 1 month
measure: Execution Speed
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Facultad Ciencias de la Actividad Física y del Deporte
Study officials:
affiliation: Universidad Politecnica de Madrid
name: Jesús Rivilla, PhD
role: STUDY_DIRECTOR
affiliation: Universidad Politecnica de Madrid
name: Jorge Lorenzo-Calvo, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01334658: Study of Corneas Undergoing Balanced Salt Solution(BSS ®) Versus Glucose-bicarbonate-Ringer Lactate in Cataract Surgery
Official title: Study of Endothelial Cell Density of Corneas Undergoing Phacoemulsification Surgery Using Balanced Salt Solution (BSS ®) Versus Glucose-bicarbonate-Ringer Lactate as Irrigating Solution: a Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: Corneal endothelium
Cataract surgery
Irrigation solutions intraocular
Phacoemulsification
Lead sponsor: Grupo de Estudos em Oftalmologia Clínica e Cirúrgica
Sponsor class: OTHER
Collaborators: name: CLIHON
First posted: 2011-04-13
Enrollment: 64
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study aimed at evaluating the effectiveness and impact of two intraocular irrigating solution (BSS ® versus glucose-bicarbonate-Ringer Lactate - GBRL) on the health of the cornea after cataract surgery by phacoemulsification.


Eligibility criteria: Inclusion Criteria:

* Uncomplicated senile cataract
* Visual acuity (VA) between 20/40 and 20/400
* Healthy corneas

Exclusion Criteria:

* Mental incapacity
* Patients with coexisting diseases of the cornea
* Presence of corneal opacity
* Uncontrolled glaucoma
* Uncontrolled diabetes mellitus
* Uveitis
* Cells or flare in the anterior chamber
* Prior intraocular surgery
* Patients using topical steroids or systemic
* Traumatic cataract, hereditary or toxic

Primary outcomes:
measure: Increase in central corneal thickness (CCT)
timeFrame: Two days after surgery.
measure: Increase in central corneal thickness (CCT)
timeFrame: Thirty days after surgery.
measure: Increase in central corneal thickness (CCT)
timeFrame: Ninety days after surgery.
measure: Decrease in the percentage of endothelial cell density (ECD)
timeFrame: Two days after surgery.
measure: Decrease in the percentage of endothelial cell density (ECD)
timeFrame: Thirty days after surgery.
measure: Decrease in the percentage of endothelial cell density (ECD)
timeFrame: Ninety days after surgery.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CLIHON
name: Hermelino L Oliveira Neto
role: STUDY_DIRECTOR
affiliation: State University of Feira de Santana (UEFS)
name: Israel C Marques Neto
role: PRINCIPAL_INVESTIGATOR
affiliation: State University of Feira de Santana (UEFS)
name: Brunno B Barros
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04492696: Comparison of Concussion Education Programs
Official title: Comparison of Concussion Education Programs and Intent to Report Concussion in High School Football Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Concussion, Brain
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-07-30
Enrollment: 118
Sex: MALE
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Importance: Concussion underreporting leads to delays in diagnosis and treatment, resulting in prolonged recovery. Athletes' report of concussion symptoms is therefore an important component of risk reduction. Numerous educational interventions to improve concussion knowledge and reporting exist.

Objective: Evaluate the comparative efficacy of three concussion education programs in improving concussion-reporting intention.

Design: Randomized clinical trial conducted from August 2018 to October 2018, with assessment before, immediately after, and one-month after educational intervention.


Eligibility criteria: Inclusion:

* Athletes from three high school football teams in California.
* In attendance for practice on both study dates
* Provided signed assent and parental consent.

Exclusion:

* Did not complete more than 50% of the questionnaire.

Primary outcomes:
measure: Improvement in concussion reporting intention among athletes
timeFrame: 1 month
Secondary outcomes:
measure: Improvement in concussion knowledge among athletes
timeFrame: 1 month
measure: Improvement in concussion attitudes among athletes
timeFrame: 1 month
measure: Improvement in concussion perceived normative beliefs among athletes
timeFrame: 1 month
measure: Improvement in concussion perceived behavioral control among athletes
timeFrame: 1 month
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
References:
Clinical trial NCT04642196: COVID-19 in Home Healthcare
Official title: COVID-19 in Home Healthcare and Mortality
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2020-11-24
Enrollment: 155
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult residents in home health care.

Brief summary: Assessment of cause of Death in home Healthcare residents in Östergötland County, Sweden, who had a positive COVID-19 diagnosis and died between March and September 2020.

Our aim is to evaluate the pattern of comorbidity and frailty in a group of individuals in home healthcare with positive COVID-19 diagnoses who had a fatal outcome, and a second aim is to assess the contribution of COVID-19 to those fatal outcomes.


Eligibility criteria: Inclusion Criteria:

* adult (\< 18 years) individuals and
* cared for in home healthcare in Östergötland county and
* positive COVID-19 diagnosis and
* diseased between March and September 2020

Exclusion Criteria:

* none

Primary outcomes:
measure: Frailty
timeFrame: Up to one month before death
measure: Comorbidity
timeFrame: Up to one month before death
Secondary outcomes:
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Dept of anesthesia
Study officials:
References:
citation: Nilsson L, Andersson C, Sjodahl R. COVID-19 as the sole cause of death is uncommon in frail home healthcare individuals: a population-based study. BMC Geriatr. 2021 Apr 20;21(1):262. doi: 10.1186/s12877-021-02176-z.
Clinical trial NCT04704596: Lung Ultrasound Versus Dynamic Lung Compliance to Detect the Optimum PEEP After Alveolar Recruitment for Patients Undergoing Laparoscopic Gastric Sleeve Surgery
Official title: Lung Ultrasound Versus Dynamic Lung Compliance to Detect the Optimum PEEP After Alveolar Recruitment for Patients Undergoing Laparoscopic Gastric Sleeve Surgery, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Ventilation During Anesthesia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-01-11
Enrollment: 60
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: PREVENTION

Brief summary: The aim of this study is to evaluate The role of transthoracic lung US as a clinical tool in Comparison to dynamic lung compliance for detection of optimum PEEP for obese patients undergoing laparoscopic gastric sleeve surgery.


Eligibility criteria: Inclusion Criteria:

* physical status American Society of Anesthesiologist(ASA) I or II

Exclusion Criteria:

* Patients refuse ASA physical status more \> II
* Patients with pre-existing significant pulmonary disease with abnormalities in spirometry, previous lung surgery, home oxygen therapy and signiﬁcant cardiac dysfunction.
* Patients with pulmonary hypertension.

Primary outcomes:
measure: detection of the optimum PEEP which is measured in mmHg
timeFrame: intraoperative period
Secondary outcomes:
measure: prevention of postoperative pulmonary complications
timeFrame: 1st 24 hour
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University hospitals
Study officials:
References:
Clinical trial NCT01121796: Influence of Vitamin D on Inflammatory Bowel Disease Remission
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inflammatory Bowel Disease
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Technion, Israel Institute of Technology
First posted: 2010-05-12
Enrollment: 90
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: Vitamin D has been shown to influence a multitude of systems. We intend to see whether different types of Vitamin D supplements have an effect on inflammatory bowel disease.


Eligibility criteria: Inclusion Criteria:

* Mild to moderate inflammatory bowel disease

Exclusion Criteria:

* Hypersensitivity to milk products

Primary outcomes:
measure: Inflammatory disease remission
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
Clinical trial NCT00525096: Exemestane + Celecoxib vs Exemestane + Placebo in Metastatic Breast Cancer
Official title: A Multicenter Randomized Phase III, Double-blind Study Comparing Efficacy of the Association of Exemestane and Celecoxib Versus Exemestane and Placebo in Menopausal Patients With Metastatic Breast Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Metastatic Breast Cancer
Lead sponsor: ARCAGY/ GINECO GROUP
Sponsor class: OTHER
First posted: 2007-09-05
Enrollment: 157
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To discover if the adding of a coxib increases the efficacy of the Aromasine.


Eligibility criteria: Inclusion Criteria:

* Femal patient aged \> 18 years
* Histologically proven breast cancer
* Menopausal patient according to the following definition:

  * amenorrhoea \> 1 year or menopause affirmed by a rate of oestradiol or hypophyseal gonadotrophin
  * surgical ovariectomy
  * treatment by LHRH analog
  * ovarian suppression by radiotherapy
  * amenorrhoea induced by chemotherapy \> 1 year
* Oestradiol and/or progesterone positive receptors
* Presence of one or several metastatic lesion:

  * mesurable lesion
  * bone metastase were detected by bone scintigraphy
* Patient who can have received:

  * Adjuvant chemotherapy and/or hormonotherapy (Tamoxifen)
  * Metastatic Treatment by chemotherapy
* PS \< 2
* Adequate biological values
* Patient who has clearly given her consent by signing on informed consent form prior to participation

Exclusion Criteria:

* Patient previously treated with hormonotherapy in metastatic phase
* Antecedent of treatment with aromatase inhibitors
* local relapse (with the exception of cutaneous thoracic nodes)
* Patient with only one metastatic lesion like: pleurisy , ascites, lung Lymphangitis carcinomatosa

Primary outcomes:
measure: Progression free survival
timeFrame: 5 years
Secondary outcomes:
measure: Objective response rate
timeFrame: 6 months
measure: Quality Of Life + pain
timeFrame: 6 months
measure: Overall survival
timeFrame: 5 years
measure: Tolerance
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Centre Hospitalier Lyon Sud - France
name: Gilles FREYER, PhD
role: PRINCIPAL_INVESTIGATOR
References: