louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05755230: Prospective Cohort of Perioperative Results
Official title: My Journey - Prospective Cohort of Perioperative Results
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Perioperative/Postoperative Complications
Keywords: Periopererative
Enhanced Recovery
Lead sponsor: COPAL - My Journey
Sponsor class: NETWORK
First posted: 2023-03-06
Enrollment: 50000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing surgery.

Brief summary: Perioperative online register of the care process and outcomes. Observational prospective cohort.

Detailed description: Center are invited to join the perioperative register where they input anonymized data about the surgical process and outcome.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing surgery

Exclusion Criteria:

* None

Primary outcomes:
measure: Perioperative International Register
timeFrame: 20 years
Secondary outcomes:
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: COPAL
Study officials:
References:
Clinical trial NCT00534248: Study to Evaluate the Safety and Effectiveness of Zostavax™ in Subjects 50 - 59 Years of Age (V211-022)
Official title: A Phase III Clinical Trial to Evaluate the Efficacy, Immunogenicity, Safety and Tolerability of Zostavax™ in Subjects 50-59 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Shingles
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-09-24
Enrollment: 22439
Sex: ALL
Minimum age (years): 50
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will look at how well Zostavax™ works in preventing shingles in participants ages 50-59 years old.


Eligibility criteria: Inclusion Criteria:

* Must be between 50 - 59 years of age
* No fever on day of vaccination
* Females of reproductive potential must be willing to use acceptable form of birth control

Exclusion Criteria:

* Have received chicken pox or shingles vaccine
* Have already had shingles
* Have recently had another vaccination
* Pregnant or breast feeding. Have participated in another research study in the last 30 days
* You are taking certain antiviral drugs
* History of allergic reaction to any vaccine component, including gelatin or neomycin

Primary outcomes:
measure: Incidence of Confirmed Herpes Zoster (HZ) Cases by Vaccination Group
timeFrame: 2 Years
Secondary outcomes:
measure: Varicella-zoster Virus (VZV) Antibody Response at 6 Weeks Post Vaccination by Vaccination Group
timeFrame: 6 Weeks
measure: Number of Participants Reporting One or More Serious Adverse Experiences by Vaccination Group During the 42-day Postvaccination Follow-up Period
timeFrame: Through 42 days post-vaccination
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Gilbert PB, Gabriel EE, Miao X, Li X, Su SC, Parrino J, Chan IS. Fold rise in antibody titers by measured by glycoprotein-based enzyme-linked immunosorbent assay is an excellent correlate of protection for a herpes zoster vaccine, demonstrated via the vaccine efficacy curve. J Infect Dis. 2014 Nov 15;210(10):1573-81. doi: 10.1093/infdis/jiu279. Epub 2014 May 13.
citation: Levin MJ, Schmader KE, Gnann JW, McNeil SA, Vesikari T, Betts RF, Keay S, Stek JE, Bundick ND, Su SC, Zhao Y, Li X, Chan IS, Annunziato PW, Parrino J. Varicella-zoster virus-specific antibody responses in 50-59-year-old recipients of zoster vaccine. J Infect Dis. 2013 Nov 1;208(9):1386-90. doi: 10.1093/infdis/jit342. Epub 2013 Aug 1.
citation: Schmader KE, Levin MJ, Gnann JW Jr, McNeil SA, Vesikari T, Betts RF, Keay S, Stek JE, Bundick ND, Su SC, Zhao Y, Li X, Chan IS, Annunziato PW, Parrino J. Efficacy, safety, and tolerability of herpes zoster vaccine in persons aged 50-59 years. Clin Infect Dis. 2012 Apr;54(7):922-8. doi: 10.1093/cid/cir970. Epub 2012 Jan 30.
Clinical trial NCT01414530: Oral Contraceptive During Menopausal Transition
Official title: Effects of Oral Contraceptive on Muscle or Joint Ache in Women During Menopausal Transition
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Perimenopause
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2011-08-11
Enrollment: 52
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Muscle or joint pain is one of the most common symptoms during menopausal transition. As this could be severe enough to affect social and daily life and to reduce quality of life, attentions should be paid about this.

Although understanding of muscle or joint pain related to menopause is still insufficient, estrogen can play an important role. Previous studies have shown that estrogen protects cartilage in both animals and humans.

However, perimenopause is different from postmenopause, in the point that estrogen is still secreted with a great fluctuation.

Until now, no study has been performed to evaluate the effects of oral contraceptive on muscle or joint pain in women during menopausal transition. Moreover, since menopausal symptoms vary according to ethnicity and culture, a study in Korean population is necessary.

Therefore, this randomized controlled trial was designed to evaluate the effects of oral contraceptive on muscle or joint pain in women during menopausal transition, compared to NSAID (non-steroidal anti-inflammatory drug).


Eligibility criteria: Inclusion Criteria:

* Perimenopausal women aged 45 or more
* Women who have multiple joint or muscle pain for at least 3 months (at least two sites out of upper and lower extremities or axial)

Exclusion Criteria:

* Rheumatoid arthritis, ankylosing spondylitis, rheumatic polymyalgia, Inflammatory myopathy
* pregnancy
* History of hysterectomy or bilateral oophorectomy
* Vasomotor symptoms
* History of surgery of musculoskeletal system
* History of cancer
* Abnormalities of thyroid function
* Focal neurologic deficit
* Smoking within 1 year
* Uncontrolled hypertension
* Coronary heart disease
* Diabetes mellitus
* Stoke
* Active thromboembolism
* Undiagnosed vaginal bleeding
* Acute hepatic dysfunction
* Gastrointestinal ulcer
* Severe renal dysfunction
* Hypersensitivity to drugs
* Current hormone user or past users within 3 months

Primary outcomes:
measure: improvement in symptoms
timeFrame: Eight weeks
Secondary outcomes:
measure: quality of life
timeFrame: Eight weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Gangnam-gu
Study officials:
References:
Clinical trial NCT06280430: Vascular Affection in Behcet Disease
Official title: Serum Elafin :A Biomarker in Behcet Disease and Its Relation to Vascular Involvement and Disease Activity
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Behcet Disease and Vascular Involvement
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 45 patients with behcet disease aged(20-45) in comparison with 45 heathy participant s

Brief summary: To measure the level of serum elafin in patients with behcet disease and to assess the correlation between serum elafin and vascular affection and their relation with disease activity

Detailed description: Behcet disease is a chronic multi systemic inflammatory disease characterized by recurrent oral and genital ulcers and multiple systemic affection . Elafin is a serine protease inhibitor produced mainly by epithelial cells . previous studies documented the role of serum elafin in pathogenesis of behcet disease.vascular complications may be one if the earliest manifestation leading to the diagnosis of behcet disease.

Eligibility criteria: Inclusion Criteria:

* patients diagnosed as behcet disease Age (20-45)

Exclusion Criteria:

* age \<20 and \>45 Other autoimmune diseases Risk factors (ischemic heart disease, diabetes) Chronic conditions (malignancy, chronic kidney disease)

Primary outcomes:
measure: To measure the level of serum elafin in behcet patients and compare it with control group
timeFrame: Within 1year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04546230: Low-Thoracic Epidural Anesthesia For Laparoscopic Nephrectomy.
Official title: Low-Thoracic Epidural Anesthesia For Laparoscopic Nephrectomy In Adult Patients.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Laparoscopic
Nephrectomy
Anesthesia
Epidural
Keywords: Epidural Anesthesia
Low-thoracic
Laparoscopic nephrectomy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-09-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Laparoscopic nephrectomy is a surgical technique to excise a diseased kidney. It's a minimally invasive technique, so when compared to open surgery, it can mean significantly less post-operative pain, shorter hospital stay, earlier return to work and daily life activities, a more favourable cosmetic result and outcomes similar to that of open surgery.

Recently, advanced laparoscopic surgery has targeted older and high risk patients for general anesthesia; in these patients, regional anesthesia offers several advantages with improved patient satisfaction. Compared with alternative anesthetic techniques, epidural anesthesia may reduce the risks of venous thromboembolism, myocardial infarction, bleeding complications, pneumonia, respiratory depression and renal failure.

The aim of this study is to compare the conventional general anesthetic technique to the regional anesthesia for laparoscopic nephrectomy, in modified lateral decubitus position using low-pressure pneumoperitoneum.


Eligibility criteria: Inclusion Criteria:

* ASA I - II.
* Adult patients scheduled for laparoscopic nephrectomy.

Exclusion Criteria:

* Patient refusal.
* Contraindication to regional anesthesia (e.g., coagulopathy, site infection).
* Allergy to local anesthetics.

Primary outcomes:
measure: Overall patient satisfaction.
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University Hospitals
Study officials:
affiliation: Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University
name: Nazmy S Michael, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University
name: Atef K Salama, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04747730: Fostering Inmates' Well-being and Mental Health
Official title: Fostering Inmates' Well-being and Mental Health Through Transcendental Meditation: a Prison Pilot
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Well-being
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
First posted: 2021-02-10
Enrollment: 44
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The objective of the project was to provide an assessment of the impact of Transcendental Meditation on prison inmates' well-being. To achieve this goal the investigators conducted a before-and-after study in Her Majesty's Prison Warren Hill (HMP) (England). Meditation is correlated with better self-regulation and is innovative because it fosters generalisable psychological processes that support cognitive, emotional and behavioural regulation, with self-regulation being an important factor behind a variety of outcomes.

Unfortunately, the trial couldn't be completed as the investigators didn't manage to recruit a sufficient number of participants.

Detailed description: The meditation intervention consists of teaching four one-hour lessons of the Transcendental meditation technique developed and offered by the David Lynch Foundation. The technique involves the use of a sound (mantra) to effortlessly allow the mind to settle down to a state of inner calm. Meditation enables those who have learned it and regularly practice it to be more self-aware and respond in a calmer and more considered manner to whatever happens in their present experience.

Eligibility criteria: Inclusion Criteria:

* any inmate with no history of drug or alcohol abuse
* recreational drug users who have refrained from using drugs for two weeks before learning the meditation technique
* alcohol or drug addicts who are recovering from alcohol or drug use and have refrained from drug use for at least three months before taking part to the programme

Exclusion Criteria:

* informed consent not signed.
* expected stay in HMP Warren Hill shorter than six months since the beginning of the project.
* drug users and alcoholics not in rehabilitation
* people with serious mental health problems
* people who do not speak English as a first language.

Primary outcomes:
measure: Mental health: - GHQ 12 - SF-12 Health survey
timeFrame: 4 months after training
measure: Mental health: - GHQ 12 - SF-12 Health survey
timeFrame: 4 months after training
measure: Patience and trust
timeFrame: 4 months after training
measure: Positive reciprocity
timeFrame: 4 months after training
Secondary outcomes:
Other outcomes:
Locations:
city: Woodbridge
country: United Kingdom
facility: HMP Warren Hill
Study officials:
References:
Clinical trial NCT06722430: A Study to Assess Change in How Oral Icalcaprant With Itraconazole Moves Through the Body in Healthy Adult Participants
Official title: A Phase 1 Open-label Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of Icalcaprant in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: Healthy Volunteer
Icalcaprant
Itraconazole
ABBV-1354
CVL-354
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2024-12-09
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study is to assess the change of itraconazole, a strong CYP3A inhibitor, on the pharmacokinetics, safety, and tolerability of a single dose of icalcaprant in healthy participants.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) is ≥ 18.0 to ≤ 32.0 kg/m\^2 after rounding to the tenths decimal. BMI is calculated as weight in kg divided by the square of height measured in meters.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.

Exclusion Criteria:

* History of any clinically significant sensitivity or allergy to any medication or food.
* Exposure to icalcaprant within the past 90 days.
* History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption \[e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.\].

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of Icalcaprant
timeFrame: Up to approximately 14 days
measure: Time to Cmax (Tmax) of Icalcaprant
timeFrame: Up to approximately 14 days
measure: Terminal Phase Elimination Rate Constant (Beta) of Icalcaprant
timeFrame: Up to approximately 14 days
measure: Terminal Phase Elimination Half-Life (t1/2) of Icalcaprant
timeFrame: Up to approximately 14 days
measure: Area under the plasma concentration-time curve (AUC) of Icalcaprant
timeFrame: Up to approximately 14 days
measure: Area under the plasma concentration-time curve from time 0 until the last measurable Concentration (AUCt) of Icalcaprant
timeFrame: Up to approximately 14 days
measure: Area under the plasma concentration-time curve from time 0 to infinity (AUCinf) of Icalcaprant
timeFrame: Up to approximately 14 days
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to approximately 47 days
Secondary outcomes:
Other outcomes:
Locations:
city: Grayslake
country: United States
facility: Acpru /Id# 271617
state: Illinois
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02925130: Beta2-mimetic and Central Nervous System
Official title: Beta2-mimetic and Central Nervous System: Effects of Salbutamol on Cortical Excitability and Cerebral Activation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adrenergic Beta-2 Agonist Effect
Albuterol Effect
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2016-10-05
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Beta2-mimetics such as Salbutamol have been shown to have ergogenic effects. Acute and chronic inhaled or oral doses of Salbutamol have been shown to increase whole body exercise and muscle performances. The underlying mechanisms are however unclear. Some data suggest that Salbutamol may have some effects on the central nervous system which may explain the improved exercise and neuromuscular performances. The present study aims to assess the effects of acite inhaled or oral Salbutamol intake on the neuromuscular system by using neurostimulation techniques and magnetic resonance imaging.

Detailed description: The effects of Salbutamol intake will be assessed by using transcranial magnetic stimulation on one hand and magnetic resonance imaging on the other hand. Maximal voluntary activation and cerebral activation will be measured during motor tasks performed until exhaustion after acute inhaled slabutamol intake, acture oral salbutamol intake or oral placebo intake.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects without respiratory and cordiovascular diseases
* Male
* Age between 18 and 35
* Trained subjects (\>6 hours of physical activity per week)
* Non- or ex-smoker (smoking cessation since at least 1 year)

Exclusion Criteria:

* Respiratory, cardiovascular and metabolic diseases
* Neuromuscular diseases
* thyrotoxicosis, or diabetes treated with insulin
* alcoholism
* MRI contraindication
* TMS contraindication

Primary outcomes:
measure: Maximal voluntary activation
timeFrame: Measured immediatly after treatment intake (within 1 h)
Secondary outcomes:
measure: Cortical activation
timeFrame: Measured immediatly after treatment intake (within 1 h)
measure: Exercise endurance
timeFrame: Measured immediatly after treatment intake (within 1 h)
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Grenoble University Hospital
Study officials:
affiliation: University Hospital, Grenoble
name: Michel Guinot, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06192030: Machine Learning Predicts Survival and Mutations in Ovarian Metastases of Colorectal Cancer
Official title: Machine Learning-based Model for Prediction of Survival and Mutations in Ovarian Metastases of Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ovarian Metastases of Colorectal Cancer
Keywords: Krukenberg tumor
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ovarian metastases from colorectal cancer

Brief summary: The study aimed to develop and validate models to predict survival outcome and key mutations in patients with ovarian metastases of colorectal cancer, as well as to compare the differential gene expression between long-survival group and short-survival group.

Detailed description: The investigator performed a retrospective-prospective cohort study with the aim of developing and validating comprehensive models to predict survival outcome and key mutations from multimodality data in patients with ovarian metastases of colorectal cancer. Secondly, the investigator aimed to compare the differential gene expression between long-survival group and short-survival group.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed colorectal cancer
* Unilateral or bilateral ovarian masses confirmed by peroperative imaging examination
* Patient requiring resection of their ovarian and/or peritoneal carcinomatosis
* 18 ≤ Age ≤ 85
* World Health Organization performance status ≤ 1
* Life expectancy \> 12 weeks
* Adequate haematological, liver and renal function
* Patient information and signature of the informed consent form before the start of any treatment procedures

Exclusion Criteria:

* Ovarian metastases of origin other than colorectal
* Primary ovarian tumor
* Clinical data missing

Primary outcomes:
measure: Overall survival
timeFrame: At least 3-year follow up
measure: Disease-free survival
timeFrame: At least 1-year follow up
measure: Peritoneal-free survival
timeFrame: At least 1-year follow up
Secondary outcomes:
measure: Rates of key gene mutation
timeFrame: At least 1-year follow up
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sixth Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT02201030: Immunogenicity and Safety Study of NBP606 in Healthy Infants
Official title: Multi-Center, Randomized, Double-Blind, Phase III Trial to Assess the Immunogenicity and Safety of Primary Vaccination With NBP606 in Healthy Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumococcal Infections
Lead sponsor: SK Chemicals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-07-25
Enrollment: 577
Sex: ALL
Minimum age (years): 42
Maximum age (years): 98
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will assess the immunogenicity and safety of primary vaccination with NBP606 compared to the existing commercial vaccine, when given concomitantly with routine pediatric vaccinations.


Eligibility criteria: Inclusion Criteria:

* Healthy Infants between 42 and 98 days of age (approximately 2 months) at the time of enrollment.
* The LAR (Legally Authorized Representative) who understand the requirements of the study and voluntarily consent to participate in the study.

Exclusion Criteria:

* Known hypersensitivity to any components of the pneumococcal vaccine
* Any confirmed or suspected immunosuppressive or immunodeficient conditions
* Coagulation disorder contraindicating IM(intramuscular) vaccination
* Subject has received any licensed vaccine(not including BCG and Hepatitis B)
* Participation to another study

Primary outcomes:
measure: Proportion of subjects with the targeted antibody concentration
timeFrame: 1 month after the primary vaccination
Secondary outcomes:
measure: Geometric mean concentration ratio
timeFrame: 1 month after the primary vaccination
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Confidential
Study officials:
affiliation: Clinical Research Center
name: Confidential Investigator
role: PRINCIPAL_INVESTIGATOR
References: