louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03289156: Strategies for Responding to Stress
Official title: Strategies for Responding to Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2017-09-20
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief summary: The purpose of this study is to examine whether changes in psychological and physiological responses differ based on different strategies for responding to stress.

Detailed description: The purpose of this study is to examine whether changes in psychological and physiological responses differ based on different strategies for responding to stress. Different strategies being examined in this study include exercise and arousal reappraisal.

Eligibility criteria: Inclusion Criteria:

* Males and females ages 18 to 35
* Speaks English fluently
* Passes the Physical Activity Readiness Questionnaire-Plus
* Mild to Moderate depression symptoms as measured by the Beck Depression Inventory-II (a score ≥14 but ≤25)

Exclusion Criteria:

* Hearing or visually impaired such that it will interfere with ability to participate effectively
* Currently exercising regularly, defined as exercising at a moderate-intensity more than 2 times a week, for at least 20 minutes each time.

Primary outcomes:
measure: Stress Reappraisal
timeFrame: One day
Secondary outcomes:
measure: Psychological Response to Stress
timeFrame: One day
measure: Physiological Response to Stress
timeFrame: One day
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas at Austin
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Jolene Jacquart, MA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06778356: Effect of Environment on the Central and Peripheral Nervous System
Official title: Effect of Environment on the Central and Peripheral Nervous System
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Rumination
Keywords: Rumination, nature exposure, respiratory sinus arrhythmia, blood pressure
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2025-01-16
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main goal of this study is to understand how different environments influence both mental responses, like overthinking (rumination), and physical reactions, such as heart rate and blood pressure, after a challenging task.

Detailed description: This study aims to explore the restorative effects of nature exposure on rumination- a mental process that affects attention-and cardiovascular responses to a challenging task. A total of 95 participants will be randomly assigned to either a built or natural environment. Each participant will take part in a 2.5-hour session. Initially, an electrocardiogram (ECG) will be attached to measure heart activity. Participants will then engage in a 30-minute task designed to immerse them in their assigned environment (the ABC engagement task). Following this, they will have a 10-minute period of quiet relaxation to establish baseline cardiovascular measures. After baseline, participants will complete a challenging task (the Remote Associates Test (RAT)), which is designed to induce sympathetic arousal. Afterward, they will rest quietly for another 10 minutes to monitor cardiovascular recovery. Finally, participants will complete post-task surveys through Qualtrics, assessing their state of rumination, perceived difficulty of the task, effort levels, and expectations of success.

Eligibility criteria: Inclusion Criteria:

* Individuals 18 years of age or older.

Exclusion Criteria:

* Individuals with a history of cardiovascular disease or disorders, those who are pregnant, or are taking medications which may alter/affect cardiovascular function.

Primary outcomes:
measure: Respiratory Sinus Arrhythmia (RSA)
timeFrame: Respiratory sinus arrhythmia will be measured during a baseline (20 minutes), challenging task (19 minutes) and the recovery period (10 minutes).
measure: Blood pressure
timeFrame: Systolic (SBP) and diastolic blood pressure (DBP) will be measured during a baseline (20 minutes), challenging task (19 minutes), and recovery period (10 minutes).
measure: Remote Associates Test (RAT)
timeFrame: Participants will complete the RAT task for 19 minutes (44 trials).
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
Study officials:
References:
Clinical trial NCT01361256: Study of WA-NG Telescope Prosthesis in Patients With End-stage Age-related Macular Degeneration
Official title: Pilot Study of WA-NG Telescope Prosthesis in Patients With Central Vision Impairment Associated With End-stage Age-related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Age Related Macular Degeneration
Keywords: Macular Degeneration
Visual Impairment
Implantable Telescope
Lead sponsor: VisionCare, Inc.
Sponsor class: INDUSTRY
First posted: 2011-05-26
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a pilot study to evaluate the safety of the Model WA-NG telescope prosthesis in patients with bilateral moderate to profound central vision impairment due to end-stage age-related macular degeneration.

Detailed description: Patients will be screened for eligibility and informed consent will be obtained from those who meet screening criteria and are interested in participating in the study. Eligible patients will be examined preoperatively to obtain a medical history and to establish a baseline for ocular condition. Baseline measurements will include successful use of an external telescope.

Postoperatively, patients will undergo ophthalmic evaluation at regular intervals as specified in this protocol and will be required to return for 6 to 10 additional visits for vision training with a low vision specialist.

Eligibility criteria: Inclusion Criteria:

* Bi-lateral, stable, moderate to profound (20/80 to 20/800) central vision impairment due to bilateral scotoma associated with end-stage macular degeneration, defined as retinal finds of bilateral, geographic atrophy or disciform scar with foveal involvement. Phakic in the operative eye. Must achieve a 5 letter improved with external telescope simulator. More medical

Exclusion Criteria:

* Evidence of active CNV or any ophthalmic pathology that compromises peripheral vision of fellow eye or predisposes eye rubbing. Previous intraocular of corneal surgery of any kind in operative eye. Retinal disease, optic nerve disease, diabetic retinopathy, retinal tears, or any intraocular tumor or medical or ophthalmic condition that in the opinion of the investigator renders the subject unsuitable for participation.

Primary outcomes:
measure: Positional Stability
timeFrame: 12 months
Secondary outcomes:
measure: Adverse events
timeFrame: 12 months
Other outcomes:
Locations:
city: Tel Hasomer
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Mordecai Rosner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05022056: Impact of High-flow Nasal Oxygen During Awake Fiberoptic Bronchoscope Guided Intubation: A Retrospective Study
Official title: Impact of High-flow Nasal Oxygen During Awake Fiberoptic Bronchoscope Guided Intubation: A Retrospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Awake Fiberoptic Bronchoscope Guided Intubation
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2021-08-26
Enrollment: 200
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: Patients who underwent awake fiberoptic bronchoscope guided intubation for surgery

Brief summary: Retrospective data collection. The aim of this study is to investigate impact of high-flow nasal oxygen on safety(lowest oxygen saturation), efficiency (intubation time, need for multiple attempts) in patients underwent awake fiberoptic bronchoscope guided intubation.


Eligibility criteria: Inclusion Criteria:

1.Patients who underwent awake fiberoptic bronchoscope guided intubation for surgery

Exclusion Criteria:

1. Cases in which other procedures (e.g. arterial line cannulation) were performed prior to endotracheal intubation after entering operation room
2. Patients with Incomplete records of oxygen saturation, attempt number, and time taken for awake intubation

Primary outcomes:
measure: Intra-procedural lowest saturation
timeFrame: Intra-procedural lowest saturation
measure: need for multiple attempts
timeFrame: Intra-procedural (need for multiple attempts : during awake intubation)
measure: time taken for awake intubation
timeFrame: Intra-procedural (Time taken for awake intubation: time from entering the operating room to completion of awake endotracheal intubation)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT02541656: Dynamic Preload Dependence Indices in Laparoscopic Surgery
Official title: Dynamic Preload Dependence Indices in Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Surgery
Keywords: Preload dependence indices
pulse pressure variation
plethysmographic waveform of pulse oximetry variation
stroke volume variation
laparoscopy
pneumoperitoneum
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2015-09-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A goal-directed fluid management is definitely beneficial in high risk surgery. The fluid administration can be directed by cardiac output monitoring which evaluate the response to repeated fluid challenge or by preload dependence indices. These indices are not well validated in laparoscopic surgery while pneumoperitoneum can alter venous return or pulmonary compliance.

The aim of the study is to study the validity of pulse pressure variation to predict fluid response under laparoscopic conditions and to describe the effect of the pneumoperitoneum on the dynamic preload indicators, i.e. the pulse pressure variation, the plethysmographic waveform of pulse oximetry variation and the stroke volume variation.


Eligibility criteria: Inclusion Criteria:

* Need to laparoscopic colectomy or hepatic resection
* Written informed consent

Exclusion Criteria:

* Cardiac arrhythmia
* Esophageal and cervical pathologies
* Radial artery Allen test negative
* Allergy to anesthesic treatment, to egg or soja
* Severe kidney failure (estimated glomerular filtration rate \< 30 ml/min)
* Age \< 18 years old
* Pregnancy

Primary outcomes:
measure: Assess the validity of pulse pressure variation (in %)
timeFrame: at Day 0
Secondary outcomes:
measure: Threshold value to predict fluid response in laparoscopic conditions.
timeFrame: at Day 0
measure: Effect of the pneumoperitoneum insufflation on the preload dependence indices : plethysmographic waveform of pulse oximetry variation .
timeFrame: at Day 0
measure: Effect of the pneumoperitoneum insufflation on the preload dependence indices : stroke volume variation .
timeFrame: at Day 0
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
References:
Clinical trial NCT03103256: Clinical Trial to Evaluate the Efficacy and Safety of YHP1701
Official title: A Multi-center, Randomized, Double-blind, Parallel-group Phase III Clinical Trial to Evaluate the Efficacy and Safety of YHP1701 Fixed Dose Combination in Patients With Dyslipidemia and Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension and Hyperlipidemia
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2017-04-06
Enrollment: 106
Sex: ALL
Minimum age (years): 19
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 determine superiority of YHP1701 comparing to each monotherapy in patient with hypertension and primary hypercholesterolemia.


Eligibility criteria: Inclusion Criteria:

* Both man and woman who is over 19 years old
* Patient with dyslipidemia and hypertension

Exclusion Criteria:

* sSBP difference is ≥20 mmHg or sDBP difference is ≥10 mmHg
* A history of cardiovascular disease
* Rhabdomyolysis, myopathy
* Hypertension or hypercholesterolemia due to secondary causes
* Uncontrolled diabetes
* Evidence of hepatic or renal disease

Primary outcomes:
measure: Percent change of LDL-Cholesterol
timeFrame: 0, 8 weeks
measure: Change of mean seated Systolic Blood Pressure
timeFrame: 0, 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul Medical Center
Study officials:
affiliation: Yuhan Corporation
name: Andrew Lee
role: STUDY_DIRECTOR
References:
citation: Kim W, Chang K, Cho EJ, Ahn JC, Yu CW, Cho KI, Kim YJ, Kang DH, Kim SY, Lee SH, Kim U, Kim SJ, Ahn YK, Lee CH, Shin JH, Kim M, Park CG. A randomized, double-blind clinical trial to evaluate the efficacy and safety of a fixed-dose combination of amlodipine/rosuvastatin in patients with dyslipidemia and hypertension. J Clin Hypertens (Greenwich). 2020 Feb;22(2):261-269. doi: 10.1111/jch.13774. Epub 2020 Jan 31.
Clinical trial NCT02215109: Retinal Vessel Diameter in Branch Retinal Vein Occlusion
Official title: Change of Retinal Vessel Diameter in Branch Retinal Vein Occlusion After Intravitreal Bevacizumab Injection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Branch Retinal Vein Occlusion
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2014-08-13
Enrollment: 25
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 25 patients will be included. All subjects with branch retinal vein occlusion scheduled for intravitreal bevacizumab injection.

Brief summary: The authors investigated the consecutive change of retinal vessel's diameter in affected eye and fellow eye of Branch Retinal Vein Occlusion.

Detailed description: Twenty five consecutive patients who had undergone intravitreal bevacizumab injection for Branch Retinal Vein Occlusion with macular edema were included in this study. All subjects were enrolled between April, 2012 and April, 2013 in the Department of Ophthalmology, Kyungpook National University Hospital.

Eligibility criteria: Inclusion Criteria:

* Best-corrected visual acuity less than 20/40
* Central subfield macular thickness (CSMT) 300 μm or greater on spectral-domain optical coherence tomography

Exclusion Criteria:

* Patients with recurrent BRVO
* History of previous treatments for BRVO including vitreoretinal surgery, intravitreal injection, subtenon injection or laser photocoagulation
* Patients with diabetes or dyslipidemia
* IOP ≥ 22mmHg, treatment for glaucoma, a family history of glaucoma, or optic neuropathy
* High myopia (\<-6 Diopters), high hyperopia (\>6 Diopters) or a history of refractive surgeries
* Co-existing retinal disease other than BRVO
* Corneal diseases include ulcer, keratoconus and a history of corneal laceration
* Cataract and other media opacities resulting in visual impairment or poor fundus images

Primary outcomes:
measure: Unoccluded retinal vessel diameter of Branch Retinal Vein Occlusion
timeFrame: 0, 1, 3, and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Dong Ho Park
state: Kyungsangpookdo
Study officials:
affiliation: Kyungpook National University Hospital
name: Dong Ho Park, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02310009: IL-1RA, Acute Exercise, and Beta-cell Function
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Exercise
IL-1RA
Beta-cell function
Type 2 Diabetes
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2014-12-05
Enrollment: 0
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Subjects (N=48) with poorly-controlled type 2 diabetes (HbA1c\>7%) will be assigned to one of the 4 following interventions in a randomised, parallel group design: \[I\] Control (placebo injection; no exercise), \[II\] Anakinra (100 mg subcutaneous injection of human recombinant interleukin-1 receptor antagonist), \[III\] Exercise (1 h cycle ergometry at 75% VO2max), \[IV\] Anakinra + Exercise. Pancreatic beta-cell function (plasma insulin responses) will be measured before and after each intervention using a hyperglycemic clamp (5.4 mM above basal glucose) combined with GLP-1 infusion (0.5 pmol/kg/min) and arginine injection (5 g bolus).


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes with HbA1c \>7%

Exclusion Criteria:

* HbA1c \>7%
* Age \<30 or \>80 y
* BMI \<25 or \>40 kg/m2
* Pregnancy
* Evidence of chronic haematological/renal/hepatic/pulmonary/heart disease
* \>2kg weight change in prior 6 months
* Alcohol consumption (men: \>14 drinks/week; women: \>7 drinks/week)
* Smoking
* Physical activity of \>150 min/week
* Contraindication to exercise
* Contraindication to use of anakinra

Primary outcomes:
measure: Beta-cell function
timeFrame: 1 day after intervention
Secondary outcomes:
measure: Glucose disposition
timeFrame: 1 day after intervention
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet & University of Copenhagen
name: Thomas P Solomon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05036109: DAILY: Vitamin D, Aspirin, ExercIse, Low Saturated Fat Foods StudY in Colorectal Cancer Patients With Minimal Residual Disease
Official title: DAILY: Vitamin D, Aspirin, ExercIse, Low Saturated Fat Foods StudY in Colorectal Cancer Patients With Minimal Residual Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Colon Cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 19
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: To learn if lifestyle changes (such as diet and exercise) combined with daily aspirin and vitamin D can affect the likelihood of advanced colorectal cancer coming back (recurring)

Detailed description: Primary Objective:

To estimate the ctDNA clearance rate of colorectal cancer participants with minimal residual disease after 3 months of optimal lifestyle interventions

Secondary Objectives:

* To evaluate the dynamics of ctDNA allele fractions after 3 months of optimal lifestyle interventions and every 3 months thereafter up to 12 months
* To estimate the recurrence rate at 1 year in subjects who complete 3 months of optimal lifestyle interventions

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years at the time of study entry
* ECOG 0-1
* Histologically documented high-risk stage II, stage III, or stage IV colorectal adenocarcinoma with no evidence of disease following definitive local therapy (including surgical resection or ablation)
* No radiographic evidence of disease by contrast enhanced CT chest/abdomen/pelvis
* Presence of detectable ctDNA mutation that matches mutations found in tumor tissue
* Completion of all standard of care adjuvant therapy
* Platelet count \>50,000
* Ability to give informed consent
* Ability to complete all questionnaires involved in study

Exclusion Criteria:

* Concurrent malignancy under active treatment
* Known active gastrointestinal bleeding or peptic ulcer disease
* Known hypersensitivity to vitamin D or aspirin
* CrCl\<30 mL/min within 30 days of starting the intervention
* Current usage of therapeutic anticoagulation (warfarin, Eliquis, Xarelto)
* Inability to safely participate in physical activity in the opinion of the treating oncologist
* Pregnant or nursing women. N.B.: urine pregnancy test will be administered as part of the screening process.
* Persistent hypercalcemia or conditions predisposing to hypercalcemia (i.e., hyperparathyroidism)
* Known symptomatic genitourinary stones

Primary outcomes:
measure: To estimate the ctDNA clearance rate of colorectal cancer patients with minimal residual disease
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Scott Kopetz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07006909: Hair Isotope Analysis for Early Cancer Detection
Official title: Hair Isotope Analysis for Early Cancer Detection
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cancer
Keywords: cancer
hair
stable isotope ratio
Lead sponsor: University of Reading
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients in the UK

Brief summary: Cancer is a major health challenge, and early detection is crucial for improving patient outcomes. Research has shown that cancer can alter the way the body processes nutrients. This study aims to explore whether these metabolic changes can be detected through a simple, non-invasive method: analysing hair. Hair grows slowly over time, potentially capturing subtle metabolic changes that occur during cancer development. By studying the nitrogen stable isotope composition in hair samples donated by individuals diagnosed with cancer, we aim to identify potential early markers of the disease. Participants will be asked to donate a small strand of hair, which will be analysed using a laboratory technique called Isotope Ratio Mass Spectrometry (IRMS). The findings from this study could contribute to new, non-invasive screening tools for early cancer detection.


Eligibility criteria: Inclusion Criteria:

Cancer diagnosis, sufficient hair

Exclusion Criteria:

-

Primary outcomes:
measure: longitudinal changes in d15N in hair
timeFrame: Approximately one year
Secondary outcomes:
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: University of Reading
Study officials:
References: