louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01467453: Clinical Application of Sensimed Triggerfish Sensor (TS) With Wireless Signal Transmission for Continuous Intraocular Pressure Measurement
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glaucoma
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2011-11-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with a diagnosis of glaucoma

Brief summary: The study objective is to investigate the clinical applicability of continuous IOP measurement using TS with radio transmission over 24 hours.

* Trial with medical device


Eligibility criteria: Inclusion criteria:

* Clinical diagnosis of glaucoma

Exclusion criteria:

* Other opticus neuropathy than glaucoma
* Corneal abnormalities (e.g. scaring)
* Dry eye disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Ophthalmic Clinic
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: 01 Studienregister MasterAdmins
role: STUDY_DIRECTOR
affiliation: University Hospital Zurich, Ophtalmic Clinic
name: Christoph Kniestedt, Assistant Prof, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02692053: Characterization of Hemostatic Disordres in Septic Shock: Searching for Biological Markers
Official title: Characterization of Hemostatic Disordres in Septic Shock: Searching for Biological Markers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Septic Shock
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: Diagnostica Stago
First posted: 2016-02-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Sepsis induces hemostatic disorders due to the exessive or inappropriate activation of inflammation, which could lead either to hypercoagulability or hypocoagulability. It is currently not possible to determine the hemostatic status of a given patient. This instability of hemostatic system is not revealed by classical tests. Thus, a better characterization of hemostatic status could certainly improve patient care. This study aims at characterizing disorders of coagulation and fibrinolysis using "global" tests such as thrombin generation test or coagulolytic test. Furthermore, the association with biological markers of interest (such as microparticles, neutrophil elastase or histones) will be evaluated.


Eligibility criteria: Eligibility criteria for patients with septic schock

Inclusion Criteria:

* septic shock (Dellinger, 2013)
* age \>18y
* hospitalized patients
* signature of an informed consent (emergency consent)
* affiliation to a social security regimen

Exclusion Criteria:

* pregnancy or breast-feeding women
* moribund patient
* oral anticoagulant therapy
* thrombophilia
* Minor patients
* Patients under tutelage

Eligibility criteria from subject without septic shock Subject blood samples without septic shock are collected from a historical healthy volunteers cohort.

Primary outcomes:
measure: Changes in endogenous thrombin potential as assessed by thrombin generation test
timeFrame: 48 hours
Secondary outcomes:
measure: Changes in Thrombin peak as assessed by thrombin generation test
timeFrame: 48 hours
measure: Changes in clot lysis time as assessed by clot lysis assay
timeFrame: 48 hours
measure: Correlation of neutrophil elastase with changes in endogenous thrombin potential
timeFrame: 48 hours
measure: Correlation of cell-derived microparticles with changes in endogenous thrombin potential
timeFrame: 48 hours
measure: Correlation of circulating histones with changes in endogenous thrombin potential
timeFrame: 48 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06906653: Population Health Management for KPNC Members With Newly Diagnosed Diabetes: A Randomized Trial of a Proactive and Augmented Initial Care Strategy
Official title: Population Health Management for Kaiser Permanente Northern California (KPNC) Members With Newly Diagnosed Diabetes: A Randomized Trial of a Proactive and Augmented Initial Care Strategy
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Type 2 Diabetes
Type 2 Diabetes Mellitus (T2DM)
Type 2 Diabetes (T2D)
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: The Permanente Medical Group
First posted: 2025-04-02
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study is a 2-arm randomized trial of Augmented Initial Type 2 Diabetes (T2D) Care vs. Usual Initial T2D Care among adults (18-74 years) with newly diagnosed T2D who have risk factors (defined by age and diagnosis HbA1c value) for suboptimal early glycemic control. Augmented Initial T2D Care comprises the elements of usual care augmented by more proactive and intensive outreach from the diabetes care team. The study team will use electronic health record (EHR) data to assess between-arm differences in diabetes-related outcomes at 6- and 12 months.


Eligibility criteria: Inclusion Criteria:

* Age 18-74 years
* Newly diagnosed with type 2 diabetes
* Kaiser Permanente Northern California member receiving care in a participating service area
* If age ≤45 years, then HbA1c\>8%
* If age\<45 years, then HbA1c\>10%

Exclusion Criteria:

* Individuals who are pregnant
* Individuals with likely type 1 diabetes (T1D)

Primary outcomes:
measure: Average hemoglobin A1c (HbA1c)
timeFrame: 6-months
measure: Average hemoglobin A1c (HbA1c)
timeFrame: 12-months
Secondary outcomes:
measure: Time to achievement of glycemic targets
timeFrame: 6-months
measure: Time to achievement of glycemic targets
timeFrame: 12-months
measure: Adherence to HbA1c monitoring
timeFrame: 6-months
measure: Adherence to HbA1c monitoring
timeFrame: 12-months
measure: Type 2 diabetes medication and statin initiation
timeFrame: 6-months
measure: Type 2 diabetes medication and statin initiation
timeFrame: 12-months
measure: Type 2 diabetes medication adherence
timeFrame: 6-months
measure: Type 2 diabetes medication adherence
timeFrame: 12-months
measure: Completion of preventative screening
timeFrame: 6-months
measure: Completion of preventative screening
timeFrame: 12-months
Other outcomes:
Locations:
city: Pleasanton
country: United States
facility: Kaiser Permanente Division of Research
state: California
Study officials:
References:
Clinical trial NCT00042653: A Study of an Investigational Medication for the Treatment of Secondary Hyperparathyroidism in Patients on Dialysis
Official title: A Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of an Oral Calcimimetic Agent (AMG 073) in Secondary Hyperparathyroidism of Chronic Kidney Disease (Hemodialysis and Peritoneal Dialysis)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Secondary Hyperparathyroidism
End Stage Renal Disease
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2002-08-06
Enrollment: 380
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: This 6 month study will assess an investigational medication for patients on dialysis with secondary hyperparathyroidism. The study will look at the effects on parathyroid hormone, calcium and phosphorus levels.


Eligibility criteria: Patients must be receiving hemodialysis; have elevated parathyroid hormone levels; not be pregnant or nursing; and not have had a heart attack in the last 3 months.

Primary outcomes:
measure: To evaluate the efficacy of AMG 073 compared with placebo by determining the proportion of subjects with a mean intact parathyroid hormone (iPTH) value <= 250 pg/mL (26.5 pmol/L) during the efficacy assessment phase.
timeFrame: Efficacy Assessment phase - final 10 weeks of study
Secondary outcomes:
measure: To evaluate the efficacy of AMG 073 compared with placebo by determining: the proportion of subjects with a reduction from baseline in mean iPTH of >= 30% during the efficacy assessment phase
timeFrame: Efficacy Assessment phase - final 10 weeks of study
measure: To evaluate the efficacy of AMG 073 compared with placebo by determining: percentage change from baseline in iPTH during the efficacy assessment phase
timeFrame: Efficacy Assessment phase - final 10 weeks of study
measure: To evaluate the safety of AMG 073 compared with placebo
timeFrame: Entire study - 26 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Lindberg JS, Culleton B, Wong G, Borah MF, Clark RV, Shapiro WB, Roger SD, Husserl FE, Klassen PS, Guo MD, Albizem MB, Coburn JW. Cinacalcet HCl, an oral calcimimetic agent for the treatment of secondary hyperparathyroidism in hemodialysis and peritoneal dialysis: a randomized, double-blind, multicenter study. J Am Soc Nephrol. 2005 Mar;16(3):800-7. doi: 10.1681/ASN.2004060512. Epub 2005 Feb 2.
Clinical trial NCT07009951: Impact of Virtual Reality in Cardiac Electrophysiology
Official title: Acute Clinical Outcomes Following the Implementation of Virtual Reality (VR) in the Electrophysiology Laboratory
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pain, Acute
Lead sponsor: University of Calabria
Sponsor class: OTHER
First posted: 2025-06-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged ≥18 years, eligible for implantation of cardiac pacing devices, able to provide informed consent and report their level of pain.

Brief summary: Pain during pacemaker or defibrillator implantation can increase patient discomfort, anxiety, and the need for deeper sedation. Using virtual reality (VR) as a non-pharmacological distraction tool may help reduce perceived pain, stabilize vital signs, and improve the overall patient experience. This prospective, single-center study evaluates whether adding VR to standard sedation lowers pain levels compared to sedation alone. Patients undergoing device implantation will be randomized to either group, with pain and vital signs monitored throughout the procedure. The study also explores patient satisfaction, adverse effects, and the potential of VR to support same-day discharge after minimally invasive procedures.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years.
* Patients who are candidates for pacemaker (PM) or implantable cardioverter-defibrillator (ICD) implantation, including new devices such as leadless PM and subcutaneous ICD (S-ICD).
* Ability to provide written informed consent.
* Ability to understand the use of the VR headset and express a pain score using the NRS scale.

Exclusion Criteria:

* Severe cognitive, psychiatric or neurological disorders that impair understanding or collaboration in the study.
* Visual and/or auditory and inner ear disorders or severe vertigo that could be aggravated by VR.
* Allergies or known adverse reactions to standard sedative therapies provided for in the protocol (e.g. midazolam) if essential for the procedure.
* Inability to correctly position the VR headset (e.g. severe facial deformities, recent trauma to the craniofacial area).

Primary outcomes:
measure: Pain and discomfort
timeFrame: during electrophysiology procedures
measure: Systolic Blood Pressure
timeFrame: during electrophysiology procedures
measure: Heart Rate
timeFrame: during electrophysiology procedures
measure: Respiratory Rate
timeFrame: during electrophysiology procedures
measure: Oxygen Saturation
timeFrame: during electrophysiology procedures
Secondary outcomes:
measure: Patient satisfaction
timeFrame: during electrophysiology procedures
measure: Hospital stay length
timeFrame: through study completion, an average of 7 days
Other outcomes:
Locations:
city: Cosenza
country: Italy
facility: "Annunziata" Hospital
Study officials:
References:
Clinical trial NCT01124851: Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ABT-652 in Subjects With Excessive Daytime Sleepiness
Official title: A Multiple Dose Study of the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of ABT-652 Administered Once Daily to Subjects With an Excessive Daytime Sleepiness Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Sleep Disorder
Keywords: Sleep disorder
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2010-05-17
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to evaluate the safety and tolerability of the drug ABT-652 given once daily to people with excessive daytime sleepiness. Subjects will be randomized to either ABT-652 or placebo in three sequential dosing groups for a 1-week treatment period.


Eligibility criteria: Inclusion Criteria

* Has current diagnosis of an excessive daytime sleepiness disorder, including narcolepsy, idiopathic hypersomnia, and obstructive sleep apnea
* Age 18 to 60 years Exclusion Criteria
* Has significant suicidal ideation
* Has a history of substance abuse
* Has a history of a certain significant medical conditions, including uncontrolled psychiatric diseases or disorders
* Use of certain medications

Primary outcomes:
measure: Laboratory Tests
timeFrame: Baseline period to end of 1-week treatment period.
measure: ECG
timeFrame: Baseline period to end of 1-week treatment period.
measure: Adverse Events
timeFrame: Baseline period till 30 days after the last dose.
measure: Vital Signs
timeFrame: Baseline period to end of 1-week treatment period.
Secondary outcomes:
measure: Maintenance Wakefulness Test
timeFrame: Baseline period to end of 1-week treatment period.
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Site Reference ID/Investigator# 43241
state: Arizona
city: Glendale
country: United States
facility: Site Reference ID/Investigator# 38092
state: California
city: San Diego
country: United States
facility: Site Reference ID/Investigator# 43264
state: California
city: New York
country: United States
facility: Site Reference ID/Investigator# 40402
state: New York
city: Durham
country: United States
facility: Site Reference ID/Investigator# 38122
state: North Carolina
Study officials:
References:
Clinical trial NCT00721851: 320-slice Coronary Computed Tomography (CT) Angiography
Official title: Coronary Artery Imaging With 320-slice Computed Tomography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Stenosis
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2008-07-25
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive eligible patients referred to the Charité and scheduled to undergo conventional coronary angiography.

Brief summary: The primary aim of this study is to determine the potential utility of 320-slice volume-CT for obtaining adequate diagnostic accuracy while at the same time improving image quality compared with previous generations of CT scanners and simultaneously enabling a reduction in both radiation exposure and contrast agent amount required.


Eligibility criteria: Inclusion Criteria:

* 40 years of age
* sinus rhythm

Exclusion Criteria:

* prior conventional coronary angiography
* unstable presentation
* coronary artery bypass graft or stent
* pregnancy or breast-feeding
* creatinine \> 2.0 mg per deciliter

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité
Study officials:
affiliation: Charité
name: Marc Dewey, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dewey M, Zimmermann E, Laule M, Rutsch W, Hamm B. Three-vessel coronary artery disease examined with 320-slice computed tomography coronary angiography. Eur Heart J. 2008 Jul;29(13):1669. doi: 10.1093/eurheartj/ehm626. Epub 2008 Feb 7. No abstract available.
citation: Zimmermann E, Dewey M. Whole-heart 320-row computed tomography: reduction of radiation dose via prior coronary calcium scanning. Rofo. 2011 Jan;183(1):54-9. doi: 10.1055/s-0029-1245629. Epub 2010 Aug 19.
citation: Dewey M, de Vries H, de Vries L, Haas D, Leidecker C. The present and future of cardiac CT in research and clinical practice: moderated discussion and scientific debate with representatives from the four main vendors. Rofo. 2010 Apr;182(4):313-21. doi: 10.1055/s-0029-1245195. Epub 2010 Mar 16.
citation: Dewey M, Zimmermann E, Deissenrieder F, Laule M, Dubel HP, Schlattmann P, Knebel F, Rutsch W, Hamm B. Noninvasive coronary angiography by 320-row computed tomography with lower radiation exposure and maintained diagnostic accuracy: comparison of results with cardiac catheterization in a head-to-head pilot investigation. Circulation. 2009 Sep 8;120(10):867-75. doi: 10.1161/CIRCULATIONAHA.109.859280. Epub 2009 Aug 24.
Clinical trial NCT01682551: Evaluation of the Prevention and Treatment Effects of Chinese Medicine on High Altitude Illness
Official title: Evaluation of the Prevention and Treatment Effects of Chinese Medicine on High Altitude Illness
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acute Mountain Sickness (AMS)
Keywords: High altitude illness
Chinese medicine body constitution
Chinese Medicine
High altitude medicine
Mountain trekking
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
Collaborators: name: China Medical University, China
First posted: 2012-09-11
Enrollment: 240
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This trial is aimed to evaluate the effects of "Wu Zhu Yu Tang" on the prevention of Acute Mountain Sickness(AMS).

Detailed description: This study is a randomized, double blind, placebo-controlled clinical trial. It aims to demonstrate that (1) Chinese medicine prescription "Wu Zhu Yu Tang" can prevent Acute Mountain Sickness(AMS) (2) "Wu Zhu Yu Tang" can prevent AMS especially for Yang-Xu body constitution.

We will randomize 240 unacclimatized healthy adults. They will be randomized after stratification of the Yang-Xu score and the AMS history to receive Chinese medicine during one ascent and placebo during the other ascent. We will take them in Hehuan mountain for two days hike (24 hours) and an overnight over 3,000m. One month before the study, the subjects will fill the "Body Constitution Questionnaire BCQ" in order to evaluate their body constitution. Before, during and after the two days hike we will measure their blood pressure, heart rate and arterial oxygen saturation. The incidence of AMS will be measured by the Lake Louise Self Report (Lake Louise Score ≥4 with headache), we will also report the Lake Louise Clinical Assessment score and Lake Louise Functional Score.

Eligibility criteria: Inclusion Criteria:

* Healthy adults

Exclusion Criteria:

* Chronic disease: cardiovascular disease, psychological disease, anemia, migraine.
* long-term use of the following materials: Chinese herbs, steroid, antibiotics.
* altitude acclimation: have been to mountain over 2000m in the past 1 month.
* Pregnancy.

Primary outcomes:
measure: The incidence of AMS will be measured by the Lake Louise Self Report (Lake Louise Score ≥4 with headache)
timeFrame: The Lake Louise Score will be measured in the noon of the second day after hiking to determine the onset of AMS.
Secondary outcomes:
measure: Blood pressure
timeFrame: Blood pressure will be measured before and after the hiking.
measure: Heart rate
timeFrame: Heart rate will be measured before and after the hiking.
measure: Arterial oxygen saturation
timeFrame: Arterial oxygen saturation will be measured before and after the hiking.
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: School of Chinese Medicine, China Medical University
Study officials:
References:
Clinical trial NCT00136851: Study Comparing the Efficacy of Amlodipine Besylate/Benazepril Versus Amlodipine in the Treatment of Severe Hypertension
Official title: A 6-Week Multi-center, Randomized, Double-Blind, Parallel Group Study Comparing the Efficacy of Amlodipine Besylate/Benazepril Versus Amlodipine in the Treatment of Severe Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: Hypertension
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-08-29
Enrollment: 259
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is designed to study the efficacy of an amlodipine besylate/benazepril treatment regimen versus an amlodipine treatment regimen in the treatment of severe hypertension.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of severe hypertension

Exclusion Criteria:

* Diastolic blood pressure (DBP) \< 60 mm Hg
* Serum potassium \< 3.5 or \> 5.5 mEq/L in the absence of all potassium supplements
* Refractory hypertension defined as systolic blood pressure (SBP) ≥ 180 mmHg and/or DBP ≥ 110 mmHg and unresponsive to triple-drug regimens

Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Percentage of subjects achieving blood pressure goal which is defined as < 140/90 mm Hg, or < 130/80 mm Hg in subjects with diabetes after 4 weeks
Secondary outcomes:
measure: Percentage of subjects achieving blood pressure goal, defined as < 140/90 mm Hg, or < 130/80 mm Hg in subjects with diabetes after 6 weeks
measure: Change from baseline in the mean sitting systolic blood pressure after 4 and 6 weeks
measure: Change from baseline in the mean sitting diastolic blood pressure after 4 and 6 weeks
measure: Percentage of subjects with swelling in legs or arms after 4 and 6 weeks
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Izzo JL Jr, Purkayastha D, Hall D, Hilkert RJ. Comparative efficacy and safety of amlodipine/benazepril combination therapy and amlodipine monotherapy in severe hypertension. J Hum Hypertens. 2010 Jun;24(6):403-9. doi: 10.1038/jhh.2009.80. Epub 2009 Nov 5.