louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02191332: Observational Study in Patients With HIV Infection Type 1 After Switching to a Viramune®-Containing Therapy Regimen
Official title: Collecting Data in Patients With HIV Infection Type 1 After Switching From a Protease Inhibitor-containing Therapy Regimen and a Viral Load Below Detection Level to a Viramune®-Containing Therapy Regimen
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-16
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV treatment centres and HIV out-patient facilities

Brief summary: Observational study to collect data on maintaining anti-retroviral activity (quantitative HIV RNA determination) and immunological activity (CD4 cells) despite switching from protease inhibitor to nonnucleoside reverse transcriptase inhibitor (NNRTI) (Viramune®).


Eligibility criteria: Inclusion Criteria:

* Adult male or female patients with HIV type 1 infection

Exclusion Criteria:

* Counter-indications according to summary of product characteristics (SPC) for Viramune tablets
* No persons under 18
* Pregnancy and breast-feeding
* Use of oral contraceptives
* Use of drugs affecting CYP450 3A metabolism

Primary outcomes:
measure: Change in viral load (HIV-RNA)
timeFrame: Baseline, after 26 and 52 weeks
measure: Change in CD4 cell count
timeFrame: Baseline, after 26 and 52 weeks
measure: Change in lipid status (lipodystrophy, triglycerides, cholesterol)
timeFrame: Baseline, after 26 and 52 weeks
measure: Change in glucose tolerance
timeFrame: Baseline, after 26 and 52 weeks
Secondary outcomes:
measure: Assessment of subjective well-being
timeFrame: up to 52 weeks
measure: Assessment of tolerability by physician and patient
timeFrame: after 26 and 52 weeks
measure: Number of patients with adverse events
timeFrame: up to 52 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01514032: Extracorporal Shockwave Lithotripsy Versus Retrograde Intrarenal Surgery for the Treatment of Kidney Stones
Official title: TOP-Stone: Treatment of Patients With Small Kidney Stones - Randomized Head-to-head Trial Comparing Extracorporal Shockwave Lithotripsy With Retrograde Intrarenal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Kidney Stones
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2012-01-20
Enrollment: 230
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 purpose of this study is to compare two established modalities for the treatment of kidneystones: ESWL (extracorporal shockwave-lithotripsy) vs. URS (uretero-reno-scopy with stone-extraction). Comparison of the stone-free rates 3month postoperative.

* Trial with surgical intervention


Eligibility criteria: Inclusion criteria: - kidneystones requiring treatment up to an maximal size of 15mm (singular or multiple kidneystones with at least one stone with min. 5mm of size)

* male and female patients between 18 and 99 years
* informed consent signed by patient after explanation of the both treatment-modalities

Exclusion criteria: - age \< 18 or \> 99

* pregnancy
* breastfeeding mother
* disorders of blood clotting
* kidneystones \> 15mm
* aneurysms of the aorta or renal artery
* severe skeletal deformations which hamper one of the treatment modalities
* synchronous stones of the ipsilateral ureter
* stones which can not visualized which X-ray or sonography

Primary outcomes:
measure: stonefree-rates 3month after therapy
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Urology
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: 01 Studienregister MasterAdmins
role: STUDY_DIRECTOR
affiliation: University Hospital Zurich, Division of urology
name: Michael Muentener, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02885532: Capacity to Consent in Acutely Intoxicated Emergency Department Patients
Official title: The University of California, San Diego Brief Assessment of Capacity to Consent Instrument in Acutely Intoxicated Emergency Department Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Informed Consent
Keywords: alcohol
Lead sponsor: Hennepin Healthcare Research Institute
Sponsor class: OTHER
First posted: 2016-08-31
Enrollment: 417
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Non-pregnant, English speaking patients aged 18 years or older with clinical evidence of acute alcohol intoxication as the predominant etiology of mental status changes were eligible.

Brief summary: The ability to meaningfully consent intoxicated and chemically dependent patients for research has inhibited medical advances in this vulnerable population. A recent pilot supported use of the University of California, San Diego Brief Assessment of Capacity to Consent tool to assess the capacity of intoxicated emergency department patients to participate in research. The objective is to determine the number of intoxicated emergency department patients who could correctly complete the questionnaire, and evaluate alcohol concentration, sedation and ability to recall participation upon sobriety.


Eligibility criteria: Inclusion Criteria:

* 18 years or older, intoxicated with alcohol

Exclusion Criteria:

* intoxication was due to a substance other than ethanol (negative breath alcohol concentration), refusal to participate, excessive agitation, or if the treating physician deemed the patient medically or psychologically unstable. Patients were also excluded if they had previously been enrolled in the study

Primary outcomes:
measure: The number of intoxicated emergency department patients who could correctly complete the questionnaire
timeFrame: Immediately
Secondary outcomes:
measure: Alcohol concentration (breath or serum)
timeFrame: Immediately
measure: Degree of sedation
timeFrame: Immediately
measure: Recall of participation
timeFrame: Between 2 and 12 hours after initial enrollment, depending on the time clinical sobriety achived
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
Study officials:
References:
citation: McCormack RP, Gallagher T, Goldfrank LR, Caplan AL. Including frequent emergency department users with severe alcohol use disorders in research: assessing capacity. Ann Emerg Med. 2015 Feb;65(2):172-7.e1. doi: 10.1016/j.annemergmed.2014.09.027. Epub 2014 Oct 23.
Clinical trial NCT02524132: Physical Activity Intervention in Preschool Children
Official title: Physical Activity Intervention in Preschool Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Hamline University
First posted: 2015-08-14
Enrollment: 25
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: In this research project, the investigators addressed if incorporating physical movements with preschoolers will help increase their ability to retain concepts learned in preschool such as letter, sound and number recognition. Movement plays an important role in the brain. Exercise shows many benefits for the brain to help maintain clearer thought, improve memory, and increase activity in the brain, especially the areas involved in memory, attention, and language. The following research includes an eight week study of the implementation of movement breaks with one preschool class, while using another class as a control group. During the two weeks of baseline data, data was collected from every student in both groups on their letter recognition with both upper and lower case, letter sound identification, and number recognition for numbers 0-10. The group that implemented movement breaks had three-five minute scheduled times to stop for movement. Data was collected and compared between the two groups to find differences in their academic performance.


Eligibility criteria: Inclusion Criteria:

* Enrolled preschool student

Exclusion Criteria:

* Enrolled in multiple preschool classes

Primary outcomes:
measure: Physical Activity as measured by a Modular Signal Recorder Accelerometer
timeFrame: 8 wks
measure: Letter recognition as measured by an Academic Growth Assessment
timeFrame: 8 wks
measure: Sound recognition as measured by an Academic Growth Assessment
timeFrame: 8 wks
measure: Number recognition as measured by an Academic Growth Assessment
timeFrame: 8 wks
Secondary outcomes:
Other outcomes:
Locations:
city: St. Paul
country: United States
facility: Hamline University
state: Minnesota
Study officials:
References:
Clinical trial NCT06201832: Cardiac Amyloidosis in HFpEF Tunisian Patients
Official title: Prevalence of Cardiac Amyloidosis in Heart Failure Patients With Preserved Left Ventricular Ejection Fraction in Tunisia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Amyloidosis
Heart Failure With Preserved Ejection Fraction
Echocardiography
CMR
Bone Scintigraphy
Prevalence
Diagnosis
Lead sponsor: University Tunis El Manar
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 87
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 60 years or older, admitted to hospital for HFpEF in the preceding year, and with an IVS thickness of 12 mm or greater.

Brief summary: Cardiac amyloidosis (CA) has recently been reported as a common cause of heart failure with preserved left ventricular ejection fraction (HFpEF), with a prevalence of 6% in elderly HFpEF patients. However, the diagnosis of CA is still challenging and requires multiple costly investigations.

Regardless of the type of CA, TTR or AL, early diagnosis significantly improves prognosis.

In this study, the investigators aimed to determine the prevalence of CA in Tunisian HFpEF patients and to identify clinical and ultrasound criteria predictive of CA.


Eligibility criteria: Inclusion Criteria:

* HFpEF during the previous year
* IVS thickness of 12mm or greater

Exclusion Criteria:

* age under 60 years
* Acute coronary syndrome complicated by HFpEF
* Congenital heart disease

Primary outcomes:
measure: Prevalence of cardiac amyloidosis among HFpEF old Tunisian Patients
timeFrame: one year
Secondary outcomes:
measure: Identify imaging criteria predictive of cardiac amyloidosis on CMR and echocardiography
timeFrame: one year
measure: Frequency of different types of cardiac amyloidosis
timeFrame: one year
Other outcomes:
Locations:
city: La Marsa
country: Tunisia
facility: Security Hospital Forces
state: Tunis
Study officials:
affiliation: University of Tunis El Manar, Faculty of Medicine of Tunis, Tunisia
name: Lilia Zakhama, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01009632: Role of Exercise for Wound Healing in the Larynx
Official title: Role of Exercise for Wound Healing in the Larynx
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Phonotrauma
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2009-11-09
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to explore quantitatively the hypothesis that "resonant voice," may enhance recovery from acute laryngeal phonotrauma, based on molecular assays from human laryngeal secretions and secondarily, clinical tests.

Detailed description: The objective is to use the following operationalized question: Does a voicing mode shown to correspond to high-amplitude, low impact vocal cord oscillations, "resonant voice," improve the amount and time-course of recovery from acute phonotrauma, compared to vocal rest or spontaneous speech, as measured with molecular assays (primarily) and with behavioral and clinical tests (secondarily)?

Eligibility criteria: Inclusion Criteria:

* males and females who have had voice training and feel they are able to produce loud voice safely;
* ages 18-49;
* generally healthy;
* normal hearing bilaterally at 20 dB to 8,000 Hz; and
* demonstrated ability to produce "resonant voice" during training as determined by the examiner perceptually.

Exclusion Criteria:

* current chronic voice problems;
* current medications that are determined to possibly influence voice (e.g. diuretics, decongestants);
* heightened gag reflex;
* small nasal passage;
* deviated septum; and
* known or suspected allergy to anesthetics.

Primary outcomes:
measure: Biomarkers in laryngeal secretions
timeFrame: Up to 24-hour post-baseline
Secondary outcomes:
measure: Phonation Threshold Pressure (PTP)
timeFrame: Up to 24-hour post baseline
measure: Direct Magnitude Estimations of phonatory effort (DME)
timeFrame: Up to 24-hour post baseline
measure: Visual-perceptual ratings of the larynx
timeFrame: Up to 24-hour post baseline
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Univesity of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Katherine Verdolini Abbott, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04673032: Radiofrequency (RF) Ablation Prospective Outcomes Study
Official title: Radiofrequency (RF) Ablation Prospective Outcomes Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Chronic
Keywords: Radiofrequency (RF)
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2020-12-17
Enrollment: 298
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Chronic Pain

Brief summary: The objective of this study is to compile real-world outcomes of Boston Scientific commercially approved radiofrequency (RF) ablation systems in the treatment of patients diagnosed with pain


Eligibility criteria: Key Inclusion Criteria:

* Study candidate is scheduled to be treated with a commercially approved Boston Scientific RF system for pain per local Directions for Use (DFU)
* Signed a valid, IRB/EC/REB-approved informed consent form

Key Exclusion Criteria:

* Meets any contraindications per locally applicable Directions for Use (DFU)
* Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or to complete study assessments

Primary outcomes:
measure: Patient Global Impression of Change (PGIC)
timeFrame: 12-months post-procedure
Secondary outcomes:
Other outcomes:
measure: Responder rate
timeFrame: 3-months post-procedure
Locations:
city: Mesa
country: United States
facility: Elite Pain and Spine Institute
state: Arizona
city: Tucson
country: United States
facility: Tucson Orthopaedic Institute
state: Arizona
city: Westport
country: United States
facility: The Spine Wellness Center in Westport
state: Connecticut
city: Atlanta
country: United States
facility: Shepherd Center
state: Georgia
city: Quincy
country: United States
facility: Quincy Medical Group
state: Illinois
city: Edina
country: United States
facility: Twin Cities Pain Clinic and Surgery Center
state: Minnesota
city: Huntersville
country: United States
facility: Carolinas Research Institute
state: North Carolina
city: Cincinnati
country: United States
facility: UC Health Pain Medicine
state: Ohio
city: Loveland
country: United States
facility: Premier Pain Treatment Institute
state: Ohio
city: Toledo
country: United States
facility: Toledo Clinic
state: Ohio
city: Sewickley
country: United States
facility: Pain Diagnostics and Interventional Care
state: Pennsylvania
city: Antwerp
country: Belgium
facility: ZNA Hoge Beuken
city: Brugge
country: Belgium
facility: St. Jan
city: Olbia
country: Italy
facility: Mater Olbia Hospital
city: Geldrop
country: Netherlands
facility: St. Anna Hospital
Study officials:
affiliation: Boston Scientific Corporation
name: Natalie Bloom Lyons, M.S.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05003232: NIRS Directed Optimal Cerebral Perfusion Pressure on the Outcome of Aneurysmal Subarachnoid Hemorrhage Patients
Official title: NIRS Directed Optimal Cerebral Perfusion Pressure on the Outcome of Aneurysmal Subarachnoid Hemorrhage Patients: A Multicenter, Single-blinded, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Optimal Cerebral Perfusion Pressure on the Outcome of aSAH Patients
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2021-08-12
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objectives: To investigate the impact of NIRS directed optimal cerebral perfusion pressure on the outcome of aSAH patients.

Study design: A multicenter, single-blinded, randomized controlled trial. Setting: Departments of critical care medicine of tertiary hospitals in China. Patients: 150 aSAH patients (≥ 18 years old) who admitted to ICU (predicted ICU duration time ≥ 24 hours)

Intervention:

Patients with aSAH will be randomly divided into the control group and the intervention group. The control group will follow the SAH guidelines. The intervention group will be given continuous NIRS and invasive blood pressure monitoring at same time. The correlation curve between the brain oxygenation index or the brain hemoglobin index (ORI/THx) and the blood pressure will be obtained through continuous monitoring. According to the correlation curve, the optimal blood pressure will be determined which provides the optimal CPP. Then the goal of blood pressure (within 5 mmHg of CPPopt) will be maintained as the target of blood pressure management for the intervention group during ICU stay.

Primary outcome: Neurological prognosis (GCS score，GOS score, and NIHSS score when discharge from ICU; GOS score at 6 months), etc.

Predicted duration of the study: 2 years.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years;
* Admitted to ICU because of aSAH.
* Predicted to stay in ICU ≥ 24 hours
* Provide written informed consent.

Exclusion Criteria:

* Unable to perform NIRS monitoring because of anatomic factors;
* Patients with severe organ failure;
* In addition to aneurysmal subarachnoid hemorrhage, there are other serious intracranial diseases (intracranial infection, cerebral hemorrhage, cerebral infarction, brain trauma, other patients after intracranial surgery);
* Patients with carotid plaque or thrombus;
* Patients with severe intracranial pneumatosis after craniotomy.

Primary outcomes:
measure: Neurological prognosis at the discharge from ICU and at 6 months
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06753032: Impact of Positive & Negative Lens-Induced Defocus on Contrast-Sensitivity in Myopic & Non-Myopic Adults
Official title: Impact of Positive & Negative Lens-Induced Defocus on Contrast-Sensitivity in Myopic & Non-Myopic Adults
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Myopia
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-12-31
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: examines the influence of lens-induced defocus on contrast sensitivity-a crucial aspect of visual performance.Each participant experiences both positive and negative defocus through different lenses, with measurements taken for contrast sensitivity using the Pelli-Robson chart. Outcomes are evaluated at baseline, 2 weeks, and 4 weeks to understand the effect of defocus over time.

Detailed description: Additional data on symptoms like visual fatigue and computer vision syndrome are gathered using the Visual Fatigue Questionnaire (VFQ) and the Computer Vision Syndrome Questionnaire (CVS-Q), respectively. This study's findings could be instrumental in refining optical treatments, offering insights into how defocus impacts visual function across refractive conditions. Results may ultimately benefit optometric practices by guiding lens prescriptions for improved contrast sensitivity and quality of life for myopic and non-myopic individuals alike.

Eligibility criteria: Inclusion Criteria:

* Adults aged 18 to 50 years.
* Participants with a confirmed diagnosis of myopia or non-myopia.
* Best corrected visual acuity of 20/30 or better.
* No history of ocular surgery or significant ocular disease.
* Informed consent was obtained.

Exclusion Criteria:

* Individuals with a history of systemic diseases affecting vision (e.g., diabetes, hypertension).
* Presence of binocular vision anomalies or strabismus.
* Pregnant or nursing women.
* Any current use of medications affecting visual function (e.g., medications causing visual side effects).

Primary outcomes:
measure: Contrast Sensitivity
timeFrame: 12 Months
measure: Visual Fatigue
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taunsa
country: Pakistan
facility: Tehsil Headquarters (THQ)
state: Punjab
Study officials:
References:
Clinical trial NCT01319032: Genetic Polymorphism and Israeli Top-level Swimmers' Performance and Expertise
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Genetic Polymorphism Connected to Top-level Swimmers
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Wingate Institute
First posted: 2011-03-21
Enrollment: 200
Sex: ALL
Minimum age (years): 13
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Swimmers training at the Wingate Institute

Brief summary: In a study conducted in our laboratory few years ago, we genotyped 22 genes in 2 athletic groups (endurance and sprinters) and in age and gender matched nonathletic controls. Few of these genes were found to be associated with athletic performance and area of specificity. Since then a few more genes have been found that are related to athletic performance, and we intend to study various genes related to 3 genetic cascade: genes associated with body fluid balance and homeostasis, genes associated with muscle strength, and genes associated with bioenergy. The results of this study compared with athletic level will provide deeper insight into the genetic mechanisms involved in performance.


Eligibility criteria: Inclusion Criteria:

* Top-level swimmers
* Other swimmers

Exclusion Criteria:

* All others

Primary outcomes:
measure: Identification of genes associated with swimming performance
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Netanya
country: Israel
facility: Wingate Institute
Study officials:
References:
citation: Ben-Zaken S, Eliakim A, Nemet D, Rabinovich M, Kassem E, Meckel Y. ACTN3 Polymorphism: Comparison Between Elite Swimmers and Runners. Sports Med Open. 2015;1(1):13. doi: 10.1186/s40798-015-0023-y. Epub 2015 Jun 14.