louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00143429: Corneal Versus Conjunctival Delivery Using a Delivery Device
Official title: Effect Of Corneal Versus Conjunctival Delivery On The Corneal Safety, Tolerability, and Antihypertensive Efficacy Of The Xalatan Ophthalmic Delivery Device
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Glaucoma, Open-Angle
Ocular Hypertension
Keywords: Primary Open Angle Glaucoma
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Compare the antihypertensive efficacy of three methods for installing Xalatan


Eligibility criteria: Inclusion Criteria:

* Diagnosis of primary open angle glaucoma or ocular hypertension in 1 or both eyes

Exclusion Criteria:

* History of closed/barely open anterior chamber angle or a history of angle closure

Primary outcomes:
measure: IOP level in the study eye
Secondary outcomes:
measure: Change in ocular safety assessments. Ocular and systemic adverse events throughout the study period
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06339229: Postoperative New-onset Proteinuria and Adverse Outcomes.
Official title: Association Between Postoperative New-onset Proteinuria and Adverse Outcomes: a Retrospective Cohort Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Proteinuria
Mortality
Lead sponsor: First People's Hospital of Foshan
Sponsor class: OTHER
First posted: 2024-04-01
Enrollment: 2983899
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Using the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes, participants aged ≥16 years who underwent surgery from January 2000 to December 2022 were included.

Brief summary: We aimed to assess the association between postoperative new-onset proteinuria, all-cause mortality, and decline in kidney function in Chinese people who underwent surgery. The exposure variable was the dipstick proteinuria values from the initial postoperative urinalysis within 30 days after surgery, categorized as negative, trace, 1+, and ≥2+. The primary outcome was 30-day mortality. The secondary outcomes included 1-year mortality and composite kidney outcome assessed using the postoperative estimated glomerular filtration rate.


Eligibility criteria: Inclusion Criteria:

* surgery patients

Exclusion Criteria:

* kidney or urinary surgery
* missing urinalysis results
* dipstick proteinuria indicated a value of "≥ trace" at least once preoperatively
* with dialysis, end-stage renal disease, or with urinary tract infection at baseline
* missing follow-up information

Primary outcomes:
measure: mortality
timeFrame: 30-day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05841329: Efficacy of tDCS to Enhance Virtual Reality Exposure Therapy Response in Acrophobia
Official title: Efficacy of tDCS to Enhance Virtual Reality Exposure Therapy Response in Acrophobia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acrophobia
Transcranial Direct Current Stimulation
Keywords: virtual reality exposure therapy
acrophobia
Transcranial Direct Current Stimulation
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to examine whether transcranial direct current stimulation(tDCS) can enhance the effect of virtual reality exposure therapy(VRET) in acrophobia in college students with significant fear of heights. The main question it aims to answer are:

• the enhancement of tDCS on the effect of VRET Participants will randomly allocated to tDCS active stimulated group and sham stimulated group and receive VRET.


Eligibility criteria: Inclusion Criteria:

* the score of the AQ-Anxiety had to be at least 45.45(1SD below the mean of a previous acrophobia sample(Cohen, 1977));
* the participants had the avoidance behaviors in daily life and recognized the fear of height was excessive and unnecessary (the severity of fear of heights not less than 5 points at a scale from 0 to 10).

Exclusion Criteria:

* previous treatment for acrophobia, history or family history of any mental disorder (except for acrophobia), metal parts in the head, medical implants, increased intracranial pressure, pregnancy, current involvement in psycho- or pharmacotherapy, and cardiovascular or neurological diseases.

Primary outcomes:
measure: Acrophobia Questionnaire(AQ)
timeFrame: one day(baseline, after invervention)
Secondary outcomes:
measure: Heights Interpretation Questionnaire(HIQ)
timeFrame: one day(baseline, after invervention)
measure: State-Trait Anxiety Inventory Form Y, (STAI-Y)
timeFrame: one day(baseline, after invervention)
measure: the Beck Anxiety Inventory(BAI)
timeFrame: one day(baseline, after invervention)
measure: Subjective Units of Distress Scale(SUDS)
timeFrame: assessed every five minutes during intervention
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
References:
Clinical trial NCT06636929: Effect of Problematic Smartphone Use
Official title: Effect of Problematic Smartphone Use on Upper Extremity Functions and Cognitive Functions
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Smartphone Addiction
Keywords: problematic smartphone use
smartphone addiction
cognitive function
reaction time
upper extremity problem
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy adults aged 18-25 years

Brief summary: There is no study that examines the effect of problematic use of smartphones, which has become a global problem today, on reaction time and cognitive functions together. This study was planned to examine the effect of problematic smartphone use on upper extremity functions and cognitive functions. Participants' problematic smartphone use will be evaluated with the Smartphone Addiction Scale Short Form. Within the scope of upper extremity functions, Quick Disabilities of Arm, Shoulder \& Hand Questionnaire, reaction time and grip strength will be evaluated. Reaction time will be measured with BlazePod Trainer (Blazepod Trainer Device, Play Coyotta Ltd, Tel Aviv, Israel). Jamar dynamometer (Performance Health, Warrenville, IL) will be used to evaluate grip strength. Cognitive functions will be assessed using the Stroop Test ÇAPA Form, Trail Making Test and Cognitive Failures Questionnaire.


Eligibility criteria: Inclusion Criteria:

* To be between 18-25 years old
* Using a smartphone for at least 1 hour a day
* Volunteering to participate in the study

Exclusion Criteria:

* Having undergone a surgical operation involving the upper extremity within the last 6 months
* History of trauma to the shoulder, elbow, hand and wrist in the last 6 months
* Presence of a diagnosed neurological, rheumatic or psychiatric disease

Primary outcomes:
measure: Smartphone Addiction Scale Short Form
timeFrame: Baseline
measure: Upper Extremity Functions-Quick Disabilities of Arm, Shoulder & Hand (Quick DASH)
timeFrame: Baseline
measure: Upper Extremity Functions-Reaction Time
timeFrame: Baseline
measure: Upper Extremity Functions-Grip Strength
timeFrame: Baseline
measure: Cognitive Functions-Stroop Test ÇAPA Form
timeFrame: Baseline
measure: Cognitive Functions-Trail Making Test
timeFrame: Baseline
measure: Cognitive Functions-Cognitive Failures Questionnaire
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Kutahya
country: Turkey
facility: Kutahya Health Sciences University
state: Center
Study officials:
affiliation: Kutahya Health Sciences University
name: Ismail Okur, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00078429: Molecular Epidemiology of Myocardial Infarction and Stroke in Older Adults - Ancillary to CHS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Disease
Cardiovascular Diseases
Heart Diseases
Cerebrovascular Accident
Myocardial Infarction
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2004-03-01
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To investigation the association of thrombosis and inflammation genes with sub-clinical cardiovascular disease and with incident myocardial infarction and stroke in older adults.

Detailed description: DESIGN NARRATIVE:

The study represents a collaborative effort among investigators of the Cardiovascular Health Research Unit, Department of Genome Sciences at the University of Washington (UW), and the multi-center Cardiovascular Health Study (CHS), including the CHS Blood Laboratory at the University of Vermont. The study links advances in thrombosis and inflammation biology, large-scale human genomics, and population and statistical genetics, with the unique resources of CHS, a large, bi-racial cohort of older adults. In older men and women without clinically apparent vascular disease, carotid intimal-medial thickness or IMT (a measure of subclinical atherosclerosis), C-reactive protein (a sensitive marker of inflammation), and D-dimer (a global marker of activation of the hemostatic system) predict subsequent clinical events such as myocardial infarction (MI) and stroke. While the therapeutic benefits of thrombolytic therapy and aspirin suggest a major role for clotting and inflammation in the etiology of coronary disease and stroke, the genetic determinants of these risk factors, which are also influenced by traditional lifestyle risk factors such as smoking and obesity, remain largely unexplored in older adults. The setting for this study is the Cardiovascular Health Study, a cohort study of 5888 older adults designed to assess risk factors for stroke and coronary disease. Data on traditional risk factors, on measures of subclinical disease, and cardiovascular events are available to the ancillary study. By integrating recent clinical and experimental data on age-related and vascular bed-specific regulation of blood coagulation, and incorporating complete human genomic DNA sequence variation data from the NHLBI-funded UW Program for Genomic Applications, the investigators will evaluate thoroughly the association of thrombosis and inflammation genes with (1) carotid IMT, CRP, and D-dimer levels measured at baseline and (2) incident MI and stroke in adults \>65 years old followed for up to 12 years.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Washington
name: Alexander Reiner
References:
Clinical trial NCT01813344: Hyper-CVAD Treatment in Lymphoblastic Lymphoma
Official title: The Clinical Outcomes of Hyper-CVAD Treatment in Lymphoblastic Lymphoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lymphoblastic Lymphoma
Keywords: Adult lymphoblastic lymphoma
Hyper-CVAD
first-line treatment
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2013-03-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult lymphoblast lymphoma patients treated with hyper-CVAD regimen in Korea

Brief summary: Treatment outcomes of lymphoblastic lymphoma (LBL) have improved by the use of the regimens for acute lymphoblastic leukemia. Hyper-CVAD is one of the most effective treatments with high remission rate in acute lymphoblastic leukemia (ALL) and LBL. However, the treatment outcome of hyper-CVAD in LBL has reported only in small number of patients from single institution. The investigators conducted this study to evaluate the hyper-CVAD regimen based treatment in LBL.

Detailed description: We will analyze treatment outcome of lymphoblastic lymphoma patients treated with hyper-CVAD regimen from 13 institutions in Korea. In all patients, hyper-CVAD was initial treatment. After achievement of response, patients either underwent hematopoietic stem cell transplantation (HSCT) or consolidation with hyper-CVAD.

Eligibility criteria: Inclusion Criteria:

* age over 18 at diagnosis
* Pathologically proven lymphoblastic lymphoma

Exclusion Criteria:

* proven HIV infection
* pretreatment with other regimens

Primary outcomes:
measure: Overall survival
timeFrame: 3-year
measure: Progression free survival
timeFrame: 3-year
Secondary outcomes:
measure: Response Rate
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou Universtiy School of Medicine
state: Kyeonggi
Study officials:
References:
Clinical trial NCT02138344: Assessment of Neuropathic Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injury + Peripheral Nerve Diseases
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2014-05-14
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with SCI and peripheral nerve diseases

Brief summary: Development of neuropathic pain is one of the most disabling sequels after spinal cord injury (SCI) and in peripheral nerve diseases. The functionality of the pain pathway in humans as well as its plastic changes following SCI can be assessed in vivo by surface electrophysiological recordings and functional magnetic resonance imaging after noxious heat stimulation of the skin. Aims: a) establishing a clinically applicable assessment of the pain pathway and characterizing its changes as a consequence of SCI and in peripheral nerve diseases in an objective manner, b) characterizing plastic changes in the pain pathway in SCI patients with neuropathic pain and in patients with peripheral nerve diseases and relating them to the development of neuropathic pain syndromes.


Eligibility criteria: Inclusion Criteria:

* Uninjured
* Scord injured subjects
* Subjects with peripheral nerve diseases
* Patients resident in Switzerland

Exclusion Criteria:

* Presence of any central psychiatric disorder (that precludes subject from giving informed and voluntary consent)
* For fMRI measurements: "yes" for any item in the MR-risk questionnaire
* Patients resident outside from Switzerland

Primary outcomes:
measure: Pain, sensory and autonomic assessments
timeFrame: 2 - 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Curt, Armin, MD
Study officials:
References:
Clinical trial NCT00400244: French-Canadian Version of the Wheelchair Skills Program (WSP)
Official title: Translation, Validation and Evaluation of the Efficacy of the French-Canadian Version of the Wheelchair Skills Program (WSP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disabled Persons
Keywords: wheelchairs
skills
french
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2006-11-16
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this project is to develop French Canadian versions of the Wheelchair Skills Program (WSP). Translating a measurement instrument in the field of biomedical sciences requires not only the language to be taken into account but also the cultural context. We will determine the measurement properties of the WST-F and complete the randomized controlled trial on the efficacy of the WSTP-F.


Eligibility criteria: Inclusion Criteria:

* eighteen (18) or older;
* use a manual wheelchair at least four (4) hours per day;
* in the rehabilitation process (including training in manual wheelchair use);
* have enough ability to develop skills included in the wheelchair skills training program;
* are willing to take part in the study;
* French-speaking individual capable of understanding enough of the English language to sign this form after carefully reading it
* competent to give informed consent or have a proxy with power of attorney;
* have the verbal endorsement of the clinical therapist (if any) to participate;
* have the permission of the attending physician or occupational therapist to participate;
* are alert and cooperative.

Exclusion Criteria:

* have an unstable medical condition (e.g. angina, seizures), as indicated by the attending physician, hospital or rehabilitation centre staff, enhanced registered nurse or self-report;
* have an emotional or psychiatric problem of a type or extent that might make participation unpleasant, as indicated by the attending physician, hospital or rehabilitation centre staff, enhanced registered nurse or self-report.

Primary outcomes:
measure: French version of the Wheelchair Skills Test
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Centre de recherche interdisciplinaire en readaption
state: Quebec
Study officials:
affiliation: Institut universitaire de geriatrie de Montreal
name: Francois Routhier, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Routhier F, Kirby RL, Demers L, Depa M, Thompson K. Efficacy and retention of the French-Canadian version of the wheelchair skills training program for manual wheelchair users: a randomized controlled trial. Arch Phys Med Rehabil. 2012 Jun;93(6):940-8. doi: 10.1016/j.apmr.2012.01.017. Epub 2012 Apr 10.
Clinical trial NCT01878344: Effects of N-acetyl Cysteine During Primary Percutaneous Coronary Intervention
Official title: Effects of N-acetyl Cysteine on Major Cardiac and Cerebral Events in Patients Undergoing Primary Percutaneous Coronary Intervention Who Have Moderate to High Risk For Contrast Induced Nephropathy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Acute ST Segment Elevation Myocardial Infarction
Lead sponsor: Suleyman Demirel University
Sponsor class: OTHER
First posted: 2013-06-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to evaluate the effects of N-acetyl cysteine on major cardiac and cerebral events in patients undergoing primary percutaneous coronary intervention who have moderate to high risk for contrast induced nephropathy.

In a sub-group of patients coronary flow reserve will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Patients with Acute ST Elevation Myocardial Infarction undergoing Primary Percutaneous Coronary intervention Who Have Moderate to High Risk For Contrast Induced Nephropathy (Mehran Score ≥5)

Exclusion Criteria:

* Patients \>18 years old with moderate to high risk for contrast induced nephropathy undergoing percutaneous coronary intervention
* Low risk for contrast induced nephropathy (Mehran Score \<5)
* Use of nephrotoxic agents (NSAIDs, aminoglycosides,recent contrast injection...)
* Infection
* Pregnancy, Lactation
* Renal failure requiring dialysis
* Hepatic failure
* Allergy to NAC
* History of Asthma
* Chronic nitrate usage
* Malignancy
* Use of corticosteroids
* Leucocytosis,Thrombocytosis,Anemia
* Blood pressure of \>180/100mmHg despite anti-hypertensive therapy

Primary outcomes:
measure: Major cardiac and cerebral events
timeFrame: 1 year
Secondary outcomes:
measure: NAC side effects (Asthma exacerbation, Pruritus, Dyspnea)
timeFrame: during hospitalization at 48 hours
Other outcomes:
Locations:
city: Isparta
country: Turkey
facility: Suleyman Demirel University
state: Mediterranean Region
Study officials:
References:
Clinical trial NCT06719544: A Study of Lithium and Enlicitide in Healthy Adult Participants (MK-0616-034)
Official title: A Clinical Study to Evaluate the Effect of Enlicitide on the Pharmacokinetics of Lithium in Healthy Adult Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-12-06
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Researchers have designed a new study medicine called enlicitide decanoate (MK-0616) as a new way to lower the amount of low-density lipoprotein cholesterol (LDL-C) in a person's blood. Enlicitide decanoate will be called "enlicitide" from this point forward. Lithium (also called lithium carbonate) is a medicine used in bipolar disorder.

Researchers want to learn about lithium when taken at the same time with enlicitide.

They want to:

* Measure a person's blood to find out if the amount of lithium in the blood is the same when lithium is taken alone or with enlicitide
* Learn about the safety of lithium when taken alone or with enlicitide and if people tolerate it


Eligibility criteria: Inclusion Criteria:

The key inclusion criteria include but are not limited to the following:

* Is medically healthy with no clinically significant medical history
* Is a continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

* Has a history or presence of clinically significant medical or psychiatric condition or disease
* Has a history of cancer

Primary outcomes:
measure: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) for Lithium in Plasma
timeFrame: At designated timepoints (up to approximately 5 days post dose)
measure: Area Under the Concentration versus Time Curve From Time Zero to Last Quantifiable Sample (AUC0-last) for Lithium in Plasma
timeFrame: At designated timepoints (up to approximately 5 days post dose)
measure: Cmax (Maximum Concentration) for Lithium in Plasma
timeFrame: At designated timepoints (up to approximately 5 days post dose)
Secondary outcomes:
measure: Number of Participants who experience a Treatment Emergent Adverse Event (TEAE)
timeFrame: Up to approximately 3 weeks
measure: Number of Participants Who Discontinue Study Due to a TEAE
timeFrame: Up to approximately 3 weeks
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion ( Site 0002)
state: Arizona
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: