louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03402074: Group Hypnosis for Stress Reduction
Official title: Group Hypnosis for Stress Reduction - a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2018-01-18
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This prospective feasibility study aims to test a 5 week group hypnosis training as intervention to reduce perceived psychological stress in healthy subjects.

Detailed description: In a pre- post comparison the feasibility of a standardized weekly 90 minutes group hypnosis training including CDs/MP3 recordings as homework to reduce perceived psychological stress in healthy subjects is investigated. Outcomes are measured quantitatively and qualitatively.

Eligibility criteria: Inclusion Criteria:

* Healthy or health-stable participants between 18 and 70 years with subjective increased intensity of stress in the last four weeks on the visual analogue scale rated between 40 -100 mm (VAS 0 - 100 mm)
* Ability to consent and sign declaration of informed consent

Exclusion Criteria:

* Current or planned participation in a stress management program within the next 17 weeks
* Current use of psychotherapeutic treatment
* presence of moderate or severe acute or chronic disease
* presence of an acute or chronic mental disorder
* Participation in a study within the last 2 months prior to enrollment
* Lack of understanding of the German language

Primary outcomes:
measure: Perceived Stress on Visual Analogue Scale
timeFrame: 5 weeks
measure: Cohens Perceived Stress Scale 10 Items
timeFrame: 5 weeks
measure: Likert-Skala
timeFrame: 5 weeks
measure: ADS-K (Depression)
timeFrame: 5 weeks
measure: General Self Efficacy Scale (Schwarzer)
timeFrame: 5 weeks
measure: SF 36 Quality of Life
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Hochschulambulanz für Naturheilkunde
Study officials:
References:
Clinical trial NCT02598882: Virtual Reality as a Tool for Rehabilitation on Elderly People
Official title: Physical Activity With an Active Video Game Provides Bigger Energy Expenditure and Less Muscle Fatigue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aged
Keywords: Elderly
Videogame
energy expenditure
electromyography
rehabilitation
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2015-11-06
Enrollment: 13
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Assessment of energy expenditure and the quadriceps muscle fatigue of healthy seniors, after two physical activities, being one of an activity guided by interactive video game (Xbox) and another on the treadmill. The participants will perform the activities in two different days, the order will be obtained by randomization.


Eligibility criteria: Inclusion Criteria:

* Participate in this study elderly
* Of both sexes,
* Over 60 years,
* without cardiac and respiratory diseases
* Who accept to participate in the research, giving your consent by signing the informed consent

Exclusion Criteria:

* Those who oppose the signing of the informed consent
* Submit proposals and activities intolerance who can't understand or accomplish correctly the procedures due to physical and or mental limitations.

Primary outcomes:
measure: Assessment of quadriceps muscle fatigue
timeFrame: one year
Secondary outcomes:
measure: Evaluation of heart rate's
timeFrame: one year
measure: Evaluation of peripheral oxygen saturation
timeFrame: one year
measure: Assessment of energy expenditure
timeFrame: one year
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Dirceu Costa
Study officials:
affiliation: University of Nove de Julho
name: Dirceu Costa, Doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06588582: Perceptual Influences From Smoking Cannabis: an Experimental Study
Official title: Exploring the Antecedents and Consequences of Cannabis Use in the Context of Coping: An Experimental Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cannabis Use
Stress
Lead sponsor: University of Colorado, Boulder
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-09-19
Enrollment: 166
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to better understand the effects of cannabis in relation to mental and physical states including its relationship with mood, cognition, perception including the experience of temperature and pain, and heart rate.

We expect that participants will be in this research study for approximately one week. The total amount of time that participants will spend completing study tasks will be about 2.5 hours across two separate in-person visits.


Eligibility criteria: Inclusion Criteria:

* 21-65 years of age
* Endorsement of at least some use of cannabis for coping purposes (\>1 on CMMQ)
* Regularly use flower cannabis products (i.e., ≥1x/week in the last 6 months)
* Proficient in English language
* At least occasional use of CBD+THC or CBD-dominant products (e.g., ≥1x/month)

Exclusion Criteria:

* Diagnosis or use of medications for substance use or psychotic disorders
* Report of other drug use (cocaine, opiates, methamphetamine) in the past 90 days or fail urine screen for any of these drugs
* Females cannot be pregnant or trying to become pregnant or nursing mothers
* Not able to provide informed consent

Primary outcomes:
measure: Blood Cortisol Levels
timeFrame: Pre-Use/Pre-Water Task, 20 minutes Post-Use, 40 minutes Post-Use
measure: Cannabis Used
timeFrame: Immediate Post-Use
measure: Blood Endocannabinoid Levels
timeFrame: Pre-Use/Pre-Water Task, 20 minutes Post-Use
measure: Heart Rate
timeFrame: Pre-Use/Pre-Water Task, Pre-Use/Post-Water Task, 20 minutes Post-Use
measure: Social Anxiety
timeFrame: Pre-Use/Pre-Water Task
measure: Inhibitory Control
timeFrame: Baseline
measure: Stress
timeFrame: Pre-Use/Pre-Water Task
measure: Blood cannabinoid levels
timeFrame: Pre-Use/Pre-Water Task, 20 minutes Post-Use
measure: Current Pain
timeFrame: Pre-Use/Pre-Water Task, Pre-Use/Post-Water Task, 20 minutes Post-Use, 40 minutes Post-Use
measure: Mood
timeFrame: Pre-Use/Pre-Water Task, Pre-Use/Post-Water Task, 20 minutes Post-Use, 40 minutes Post-Use
Secondary outcomes:
Other outcomes:
Locations:
city: Boulder
country: United States
facility: University of Colorado at Boulder
state: Colorado
Study officials:
References:
Clinical trial NCT01941082: A Study of RO6867461 Administered in Single- and Multiple-Ascending Doses in Patients With Wet Age-Related Macular Degeneration
Official title: A Multiple-Center, Non-Randomized, Open-Label, Single- and Multiple-Ascending-Dose, Parallel Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO6867461 Following Intravitreal Administration in Patients With Wet Age-Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Macular Degeneration
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-09-13
Enrollment: 24
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This multicenter, non-randomized, open-label, single- and multiple-ascending-dose study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO6867461 in patients with wet age-related macular degeneration.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 50 years of age
* Patients with age-related macular degeneration (AMD)
* Best corrected visual acuity (BCVA) of 20/40 to 20/400 (Snellen equivalent, on ETDRA charts) inclusive
* Evidence of leakage due to choroidal neovascularization (CNV)

Exclusion Criteria:

* Choroidal neovascularization (CNV) in either eye due to causes other than age related macular degeneration, such as ocular histoplasmosis, trauma, or pathologic myopia
* Known hypersensitivity to ranibizumab, fluorescein, indocyanin green (ICG) or any of the ingredients of the formulation used, or any of the medications used
* Any other restriction according to the use of ranibizumab
* Active intraocular inflammation (grade trace or above) in the study eye
* Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye

Primary outcomes:
measure: Ocular safety, assessed by BCVA (EDTRS chart), slitlamp examination, ophthalmoscopy, IOP, fundus photography, SD-OCT, angiography
timeFrame: Part A, 12 weeks; Part B, 20 weeks
measure: Safety: Incidence of adverse events
timeFrame: Part A, 12 weeks; Part B, 20 weeks
Secondary outcomes:
measure: Pharmacokinetics: Area under the concentration time curve (AUC)
timeFrame: Part A, 12 weeks; Part B, 20 weeks
measure: Pharmacokinetics: Maximum plasma concentration (Cmax)
timeFrame: Part A, 12 weeks; Part B, 20 weeks
Other outcomes:
Locations:
city: Colorado Springs
country: United States
state: Colorado
city: Baltimore
country: United States
state: Maryland
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Charlottesville
country: United States
state: Virginia
city: Belfast
country: United Kingdom
city: Bristol
country: United Kingdom
city: London
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01696682: The Optimal Width of Gastric Conduit for Minimally Invasive Esophagectomy: Wide or Narrow?
Official title: Study on the Difference of Anastomotic Leakage Ratio Between Wide and Narrow Gastric Conduit During Minimally Invasive Esophagectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anastomotic Leakage
Keywords: minimally invasive esophagectomy
anastomotic leakage
gastric conduit
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2012-10-01
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The study hypothesized that a narrow gastric conduit(less than 3cm in width) would minimize anastomotic leakage following minimally invasive esophagectomy. Therefore we raise this random-controlled research, and investigate the leakage ratio from different widths of gastric conduit formed during the operation.

Detailed description: Patients underwent minimally invasive esophagectomy in Zhongshan Hospital of Fudan University will be enrolled and be assigned to wide or narrow gastric conduit group randomly. Intra-operative blood supply and vascular SaO2 will be observed during the operation, and the rate of anastomotic leakage, together with its clinical details will be recorded in the two groups.

Eligibility criteria: Inclusion Criteria:

1. Patients underwent minimally invasive esophagectomy(three-hole procedure)
2. Clinical Staged T1-3N0M0 esophageal cancer patients or: patients who were restaged as T1-3N0M0 esophageal cancer after neo-adjuvant therapy

Exclusion Criteria:

1. With previous cancer history
2. Severe Co-morbidity

Primary outcomes:
measure: The anastomotic leakage rate
timeFrame: the anastomotic leakage of participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Division of Thoracic Surgery, Zhongshan Hospital of Fudan University
Study officials:
affiliation: Fudan University
name: Lijie Tan, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03160482: PACE4 in Thyroid Cancer
Official title: Evaluation of PACE4 Isoforms as Biomarkers in Thyroid Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroid Nodule
Keywords: Thyroid Neoplasm
Thyroid Cancer
Bethesda Classification
Biomarkers
Protein convertase
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2017-05-19
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from the territory of the CIUSSS de l'Estrie - CHUS, that underwent a subtotal or total thyroidectomy

Brief summary: The investigation of thyroid nodules is limited by the fact that up to 49% of the fine needle aspirations (FNA) performed are of "indeterminate cytological signification". Moreover, no fully reliable molecular marker for thyroid cancer have been described. The goal of this project is to study the expression of a specific kind of protein convertase in benign and in malignant thyroid nodules to determine its potential as a biomarker.

Detailed description: Patients that underwent thyroidectomy at the CIUSSS de l'Estrie-CHUS will be recruited and classified according to the pathological diagnosis. An immunohistochemistry technique, developed and calibrated for the specific protein convertase studied, will be undertaken. Results will be interpreted by a specialized pathologist.

Eligibility criteria: Inclusion Criteria:

* Men of women, aged 18-100 y.-o.
* History of subtotal or total thyroidectomy at the "Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke" (CIUSSS de l'Estrie - CHUS) between January 2010 and May 2016.

Exclusion Criteria:

* Refusal to participate to the study.
* Unavailability of the formalin-fixed, paraffin-embedded tissues.
* Uncertain pathological diagnosis.

Primary outcomes:
measure: Expression pattern of the studied protein convertase
timeFrame: Trough study completion, an average of 1 year after the patients have been operated.
Secondary outcomes:
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: CIUSSS de l'Estrie - CHUS
state: Quebec
Study officials:
affiliation: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
name: Robert Day, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fradet L, Temmar R, Couture F, Belzile M, Fortier PH, Day R. Evaluation of PACE4 isoforms as biomarkers in thyroid cancer. J Otolaryngol Head Neck Surg. 2018 Oct 19;47(1):63. doi: 10.1186/s40463-018-0311-x.
Clinical trial NCT05709782: Phase II Cohort of Spinal Stereotactic Radiotherapy in Patients Using a MR LINAC
Official title: Phase II Cohort of Spinal Stereotactic Radiotherapy in Patients Using a MR LINAC
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Spinal Disease
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2023-02-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To learn whether giving spinal stereotactic radiosurgery (SRSS) that uses a more advanced imaging scan method called Magnetic Resonance imaging with a Linear Accelerator (MR-LINAC) during treatment will lead to improved responses to treatment and better quality of life. SRSS is radiation therapy given to the area around your spine.

Detailed description: Primary objective:

• To determine the 6-month local control (LC) of the target site of treatment.

Secondary Objectives:

* To determine the 6-month change in epidural tumor volume (by volumetric measurements where applicable)
* To determine the 1-year local control of the target site

Eligibility criteria: INCLUSION CRITERIA:

1. Age ≥ 18 years old
2. Radiographically documented disease of the spine within 4 weeks of registration (candidates with or without epidural disease allowed)
3. Candidate for spine SRS/SBRT as determined by treating Radiation Oncologist or Multidisciplinary Spine Conference review
4. Maximum of 3 contiguous vertebral levels involved with metastasis in the spine to be irradiated allowed
5. Diagnosis of cancer documented
6. Motor strength ≥ 4 out of 5 in the extremity affected by the level of spinal disease planned for radiation
7. Karnofsky Performance score (KPS) ≥ 40 or ECOG score ≤ 3

EXCLUSION CRITERIA:

1. Patients with highly radiosensitive histologies likely to respond to conventional radiation therapy alone (ie lymphoma, multiple myeloma, etc)
2. Patients who are unable to undergo MRI of the spine with contrast
3. Patients who are pregnant

Primary outcomes:
measure: M. D. Anderson Symptom Inventory - Spine Tumor (MDASI-SP) questionnaires
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: Debra N. Yeboa, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02903082: Following of Myeloid-derived Suppressor Cells (MDSC) in Severe Sepsis: What Relationship With Systemic Inflammatory Syndrome?
Official title: Following of Myeloid-derived Suppressor Cells (MDSC) in Severe Sepsis: What Relationship With Systemic Inflammatory Syndrome?
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Severe Sepsis
Inflammatory Response Syndrome, Systemic
Keywords: Myeloid-Derivated suppressive cell
Sepsis
Inflammatory Response Syndrome, Systemic
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2016-09-16
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient hospitalized in intensive care for sepsis evolving for less than 48 hours with two criteria of systemic inflammatory response syndrome

Brief summary: Sepsis remains a major cause of death in developed countries. A better understanding of the mechanisms involved in the regulation of inflammatory and immune response of patients with severe sepsis is an important step that could open the way for new therapeutic approaches.


Eligibility criteria: Inclusion Criteria:

* Patient ≥18 years old
* Patient with two criteria of systemic inflammatory response syndrome and one of the four following criteria within 24 hours of hospitalization in ICU:

  * Lactate \>4 mmol/L
  * PaO2 / FiO2 \<200 in the presence of lung disease as infectious source
  * Vasopressor: adrenaline or noradrenaline ≥0.25 µg/kg/min for at least 6 hours to maintain a systolic blood pressure ≥90 mmHg or mean arterial pressure ≥65 mmHg
  * Thrombocytopenia linked to sepsis with platelet count \<100,000 / ml or a decrease ≤50% within 48 hours

Exclusion Criteria:

* Pregnancy
* progressive solid cancer
* HIV infection
* History of blood or inflammatory disease
* long-term immunosuppressive treatment
* Prior episode of Sepsis in the previous month
* Chronic Dialysis Patient
* Patient under guardianship
* Patient not affiliated with a social security system

Primary outcomes:
measure: Change in Peripheral Blood MDSC concentration during ICU hospitalization for Severe Sepsis
timeFrame: Average 30 days - Patients will be followed up until hospital discharge
Secondary outcomes:
measure: Immuno- inflammatory status
timeFrame: Day 0, Day3, Day 7 and once a week until the intensive care unit discharge
measure: MDSCs presence in the blood and bone marrow.
timeFrame: Day 0
measure: Assessment of MDSC specific gene expressions
timeFrame: Day 0 vs Days 3, 7, 14, 21, 28
measure: Assessment of MDSC functional status
timeFrame: Day 0 vs Days 3, 7, 14, 21, 28
measure: Mortality
timeFrame: Day 28 and Day 90
measure: Incidence of hospital acquired secondary infections at Day 28
timeFrame: Day 28
measure: SOFA score
timeFrame: Day 0, Day3, Day 7 and once a week until the intensive care unit discharge
Other outcomes:
Locations:
city: Limoges
country: France
facility: CHU de LIMOGES
Study officials:
References:
Clinical trial NCT06825182: Current Status of Islet Alpha Cell Function in Patients with Type 2 Diabetes
Official title: Survey on the Current Status of Islet Alpha Cell Function in Patients with Type 2 Diabetes and Interventional Study of GLP-1RA: a Multicenter, Prospective Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: Islet Alpha Cell Function
Glucagon-Like Peptide-1 Receptor Agonists (GLP1-RA)
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 1000
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: By detecting the fasting and postprandial 120-minute glucose, insulin (Insulin, INS), C-peptide (C-peptide, Cp), glucagon (GCG) levels in newly diagnosed type 2 diabetes patients, or the 0-minute, 30-minute, 120-minute glucose, INS, Cp, GCG levels during the Oral Glucose Tolerance Test (OGTT), and examining the glucose, INS, Cp, GCG levels during hypoglycemia, the current status of islet alpha cell function in diabetic patients is observed. Type 2 diabetes patients willing to participate are treated with GLP-1RA for 3 months, and then retested for fasting and postprandial 120-minute glucose, INS, Cp, GCG, or the 0-minute, 30-minute, 120-minute glucose, INS, Cp, GCG during OGTT, as well as the counter-regulatory hormone levels during hypoglycemia, to assess the improvement of islet alpha cell function by GLP-1RA.


Eligibility criteria: Inclusion Criteria:

* Willing to participate voluntarily and able to sign the Informed Consent Form before the trial;
* Newly diagnosed patients with type 2 diabetes, aged 18 years or older, meeting the WHO 1999 diagnostic criteria;
* Subjects who are capable and willing to maintain a regular diet and exercise regimen.

Exclusion Criteria:

* Patients who are allergic to GLP-1RA or have a BMI less than 24 kg/m\^2;
* History of using blood sugar-lowering medications;
* Estimated glomerular filtration rate (eGFR) less than 30 ml/(min\*1.73 m\^2);
* History of drug abuse or alcohol dependence within the past 5 years;
* Patients with poor compliance and irregular diet and exercise;
* History of diagnosed pancreatitis, pancreatic tumor, medullary thyroid carcinoma, or diabetic retinopathy stage IV or higher;
* Patients who have used systemic glucocorticoid therapy within the past 3 months;
* Presence of infection or stress within the past four weeks;
* Any other significant condition or comorbidity judged by the researcher, such as severe cardiopulmonary disease, endocrine disorders, neurological disorders, tumors, other pancreatic diseases, mental illness, history of alcohol or drug abuse.

Primary outcomes:
measure: Glucagon levels
timeFrame: 19 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hostital
state: Jiangsu
Study officials:
References: