louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03378869: Perioperative Management and Outcomes of Minimally Invasive Esophagectomy
Official title: Perioperative Management and Outcomes of Minimally Invasive Esophagectomy- Experience of a High-volume Tertiary Center in Taiwan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Cancer
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2017-12-20
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with esophageal cancer undergoing esophageal reconstruction in 2015.

Brief summary: The investigators retrospectively reviewed the data of all patients who had undergone esophagectomy and reconstruction in 2015. Patient characteristics, the surgery performed, method of anesthesia, postoperative hospitalization course, and additional surgical interventions were reviewed and analyzed.


Eligibility criteria: Inclusion Criteria:

* patients received esophageal reconstruction in 2015.

Exclusion Criteria:

* age \<18
* not malignancy

Primary outcomes:
measure: 30-day mortality
timeFrame: 30 day after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: NTUH
Study officials:
affiliation: Chief of Department of Anesthesiology, National Taiwan University Hospital
name: Ya-Jung Cheng, MD. PHD
role: STUDY_CHAIR
References:
Clinical trial NCT05393869: Evaluating Anti-Tobacco Message Effectiveness Among Lesbian, Gay, Bisexual, and Transgender Young Adults
Official title: The Effect of Nicotine and Tobacco Message Framing on Use Among Diverse Groups of Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco-Related Carcinoma
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-05-26
Enrollment: 2849
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: This trial refines and evaluates anti-tobacco messages among lesbian, gay, bisexual, and transgender (LGBT) young adults at risk for the use of more than one tobacco product (polytobacco use). Polytobacco use is associated with nicotine dependence and tobacco use into adulthood, and is disproportionately high among LGBT young adults. This trial seeks to determine effective communication of polytobacco use risk to at-risk LGBT young adults.

Detailed description: PRIMARY OBJECTIVES:

I. Identify absolute and relative risk anti-tobacco messages that effectively communicate polytobacco risks to lesbian, gay, bisexual, transgender (LGBT) young adults.

Participants view anti-tobacco messages and rate them for perceived effectiveness and reactance.

Eligibility criteria: Inclusion Criteria:

* Young adults (age 18-35 years)
* Live in the United States

At least 50% of the sample also:

* Are susceptible to multiple nicotine and tobacco product use (i.e., have used combustible tobacco or e-cigarettes at least once)

Primary outcomes:
measure: Message Perceived Effectiveness - Persuasive Potential.
timeFrame: Immediately post-exposure to intervention, up to 1 hour
measure: Perceived Effectiveness - Perceived Behavioral Impact
timeFrame: Immediately post-exposure to intervention, up to 1 hour
measure: Risk Perceptions: Absolute/Relative Risks of Cigarette vs. E-cigarette Use
timeFrame: Immediately post-exposure to intervention, up to 1 hour
measure: Behavioral Intentions to Use Tobacco
timeFrame: Immediately post-exposure to intervention, up to 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Joanne G Patterson, PhD MPH MSW
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05045469: Therapeutic Effects of Topical Herbal Medicine -Rhubarb Ointment on Rosacea
Official title: Therapeutic Effects of Topical Herbal Medicine on Rosacea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rosacea
Chinese Herbal Medicine
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2021-09-16
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effects of topical herbal medicine in the patients with rosacea.

Detailed description: Rosacea is a chronic inflammatory disorder which affects the cheek, nose, chin, forehead and eyes. It is typically characterized by cutaneous signs such as flushing, erythema, telangiectasia, papules, and pustules in the face. The pathogenic mechanism of rosacea is unknown, and there is no cure for rosacea. The therapeutic approaches include oral medicine, topical medicine and surgical interventions depending on the different subtypes of rosacea. The recent study demonstrates that combination therapy may be more effectively improved the symptoms of rosacea. Dian dao san is a topical herbal compound for reducing the features as flushing, erythema, papules, and pustules for years. The investigators hypothesize that dian dao san can be more beneficial in treating the patients with rosacea and improving the quality of life.

Eligibility criteria: Inclusion Criteria:

* Willing to sign inform consent
* Aged above 20 years old with rosacea
* No treatment for rosacea within 2 weeks

Exclusion Criteria:

* With malignant lesion in the rosacea lesion
* Rosacea lesion with high risk of infection
* Allergy to Chinese herbal medicine patch or ointment
* Pregnancy

Primary outcomes:
measure: Reduction of Flushing, Erythema, Telangiectasia, Papules, and Pustules
timeFrame: 6 weeks
Secondary outcomes:
measure: Dermatology Quality of Life Index, DQoL
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Keelung
country: Taiwan
facility: Keelung Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: YUAN-CHIEH YEH, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01376869: Investigation of the Acute Cognitive, Mood and Autonomic Effects of Hops in Healthy Participants
Official title: Investigation of the Acute Cognitive, Mood and Autonomic Effects of Hops in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mood Modulation
Modulation of Cognition
Keywords: Hops
Mood
Cognitive Function
Bioavailability
Satiety
Blood Pressure
Heart rate
Lead sponsor: Northumbria University
Sponsor class: OTHER
Collaborators: name: The New Zealand Institute of Plant and Food Research Ltd.
First posted: 2011-06-20
Enrollment: 150
Sex: ALL
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: Hops have been used for many years for their supposed sedative and anxiety reducing properties and can be found in many natural remedies for stress, anxiety and sleeping that are already available to buy.

However, human trials investigating the effects of hops have so far been limited to the effects of the combination of hops and valerian in relation to sleep. Such studies have identified that a valerian-hops mixture can result in improved sleep but Valerian alone has no effect.

The current study aims to investigate the effect of hops alone in healthy human participants aged 18-35 years.


Eligibility criteria: Inclusion Criteria:

* Male/female,
* Healthy
* Age 18-35 years old
* Non smoker
* Proficient in English
* Not taking any herbal or prescription medications
* Not pregnant seeking to become pregnant or breastfeeding

Exclusion Criteria:

* Allergy or hypersensitivity to any of the ingredients contained in the investigational product or any other foodstuff.
* Vegetarian (as the capsules contain gelatine).
* Have a history of neurological, vascular or psychiatric illness (including depressive illness and anxiety).
* Have a current/ history of drug or alcohol abuse.
* Currently take medication (excluding the contraceptive pill).
* High Blood Pressure (\>140/90)
* BMI outside of the range 18- 34.9

Primary outcomes:
measure: Mood
timeFrame: across 3 hours
Secondary outcomes:
measure: Satiety
timeFrame: across 3 hours
measure: Bioavailability of Hops
timeFrame: across 3 hours
measure: Cognition
timeFrame: across 3 hours
Other outcomes:
Locations:
city: Newcastle upon Tyne
country: United Kingdom
facility: Northumbria University
Study officials:
affiliation: Northumbria University
name: Crystal Haskell
role: STUDY_DIRECTOR
References:
Clinical trial NCT04971369: Safety Study of 89Zr-NY001 PET Imaging in Patients
Official title: Safety Study of 89Zr-NY001 PET Imaging in Patients With Fibronectin ED-B Positive Solid Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Solid Tumor, Adult
Lead sponsor: Wuxi No. 4 People's Hospital
Sponsor class: OTHER
First posted: 2021-07-21
Enrollment: 20
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: This is a single arm study to evaluate the safety and biodistribution of 89Zr-labeled NY001 (89Zr-NY001) PET imaging in patients with fibronectin ED-B domain positive solid tumors.

Detailed description: After being fully informed about the study and potential risks, all patients giving written informed consent will be evaluated to determine eligibility for study entry. Patients will receive an injection of 89Zr-NY001 and will undergo PET/CT scanning to determine uptake of 89Zr-NY001 in tumor lesions and the whole body.

Eligibility criteria: Inclusion Criteria:

1. Patients voluntarily signed informed consent;
2. Aged \>18, male or female;
3. Patients diagnosed with solid tumors confirmed by histopathology or cytology test;
4. At least two measurable solid lesions has been examined by 18F-FDG PET/CT (RECIST1.1 standard);
5. Patients with biopsy-proven fibronectin ED-B positive;
6. ECOG score ≤ 0\~3; Life expectancy of at least 3 months;
7. Women of childbearing age are required to receive serum pregnancy tests, and only those who have a negative pregnancy test for eligible subjects;
8. ALT, AST shall not exceed 3 times of the normal upper limit; Bun, Cr not exceed 1.5 times of the normal upper limit;
9. Other routine examinations are within the normal range or considered acceptable by the researchers.

Exclusion Criteria:

1. Recovery from major trauma (including surgery) within 4 weeks prior to study treatment;
2. Patients with systemic or locally severe infections, or other serious coexisting diseases;
3. Patients with allergies or allergies to any component of the imaging agent or antibody;
4. Patients who cannot perform PET/CT imaging scan;
5. Patients with abnormal immune function or who have recently used immunosuppressive or potentiating agents including various vaccines;
6. Patients with autoimmune diseases, including rheumatoid arthritis;
7. Inadequate control of arrhythmias, including atrial fibrillation;
8. Uncontrolled hypertension;
9. Syphilis, HBV, HCV, or HIV positive subjects;
10. Male and female subjects of reproductive age cannot take effective contraceptive measures;
11. Pregnant or lactating women;
12. Patients with a history of mental illness or related conditions;
13. Other subjects considered unsuitable by researchers.

Primary outcomes:
measure: Focal lesion of 89Zr-NY001 PET scanning in patients with fibronectin ED-B domain positive solid tumors.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Wuxi
country: China
facility: Wuxi No. 4 People's Hospital
state: Jiangsu
Study officials:
References:
Clinical trial NCT07000669: Bilateral Peribulbar Block for Cataract Surgery
Official title: Safety and Efficacy of Bilateral Peribulbar Block for Cataract Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Safety
Efficacy
Bilateral
Peribulbar Block
Cataract Surgery
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-06-03
Enrollment: 50
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: This Case series interventional study will be carried out on 50 patients undergoing cataract surgery at Tanta University Hospitals.

Brief summary: This study aims to evaluate the safety and efficacy of bilateral peribulbar block for cataract surgery.

Detailed description: Cataract surgery is one of the most commonly performed procedures worldwide, with local anesthesia being the preferred method due to its safety, efficacy, and cost-effectiveness.

Peribulbar anaesthesia has gained popularity due to its relative efficacy in generating ocular akinesia and anaesthesia with a reduced risk of consequences such as optic nerve damage and globe perforation.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years.
* Both sexes.
* American Society of Anesthesiology (ASA) physical status I-III.
* Patients undergoing cataract surgery

Exclusion Criteria:

* Infection at the site of the surgery.
* Allergy to any of the used drugs.
* Coagulopathy.
* Posterior staphyloma.
* Bronchial asthma.
* Bradyarrhythmia.
* Pre-existing ocular muscle paresis.
* Neurological deficit.
* Co-existing inflammatory conditions of eye.
* Complicated cataracts.
* Previously operated eyes.

Primary outcomes:
measure: Degree of pain
timeFrame: Intraoperatively
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 24 hours postoperatively
measure: Grading of Akinesia
timeFrame: Intraoperatively
measure: Incidence of adverse events
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References:
Clinical trial NCT01167569: Study of High Dose Vitamin C On Outcome in Cardiac Surgery Patients
Official title: Double-Blind, Randomized Study of High Dose Vitamin C On Outcome in Cardiac Surgery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Reperfusion Injury
Keywords: Free Radicals
Ascorbic Acid
Cardiac Surgery
Prevention of Reperfusion Injury
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2010-07-22
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: It has been shown that the stress that occurs during cardiac surgery leads to early decrease of many of the body's resources such as Vitamin C (ascorbic acid) which may contribute to complications after surgery.

This study will investigate the effects of high doses of intravenous (IV) Vitamin C on the outcome and complications after cardiac surgery.

Detailed description: Patients undergoing cardiac surgery are at significant risk for multiple major complications beyond those associated with other major operations. Most patients survive these events, but up to 10% develop injury to organ systems including the kidneys, lungs, pancreas, brain, etc. It has been shown that the stress that occurs during this critical period (cardiac surgery) leads to early decrease of many of the body's resources such as Vitamin C (ascorbic acid) which seem to contribute to these complications.

This study will investigate the effects of high doses of intravenous (IV) Vitamin C administered before, during and after the cardiac surgery.

Eligibility criteria: Inclusion Criteria:

* Adult patients 18 years or older undergoing elective or urgent (prior to hospital discharge) cardiac surgery.

Exclusion Criteria:

* History of renal insufficiency, nephrolithiasis, G6PD (glucose-6-phosphate dehydrogenase deficiency) or the chronic use of steroids.

Primary outcomes:
measure: Mortality
timeFrame: 30 days
Secondary outcomes:
measure: Renal Insufficiency
timeFrame: hospital discharge
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Robert Wood Johnson University Hospital
state: New Jersey
Study officials:
affiliation: Rutgers RWJMS
name: Alan Spotnitz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01460069: The Effect of Glucagon Like Peptide (GLP)-1 in Psoriasis
Official title: The Effect of GLP-1 in Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis
Keywords: psoriasis
liraglutide
morbidity
PASI
DLQI
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2011-10-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to investigate the effect of the GLP-1 analogue Victoza® on psoriasis in a double-blinded, randomized placebo-controlled clinical trial.


Eligibility criteria: Inclusion Criteria:

* Caucasians above 18 years of age
* Plaque psoriasis
* PASI score \>10
* No treatment or stable treatment of psoriasis during at least 3 months before inclusion
* Steady weight through 3 months with a body mass index (BMI) above 27 kg/m2
* Normal blood pressure
* Spiral or hormonal birth control for fertile women during the entire treatment period and at least 3 days after the end of the treatment period (\~5 times the plasma half-life)

Exclusion Criteria:

* Psoriasis arthritis
* Fasting plasma glucose \> 7.5 mmol/L or HbA1c \> 7.5%
* Type 1 diabetes
* Treatment for type 2 diabetes with GLP-1-based medicine (DDP-4-inhibitors or GLP-1-receptor-agonists)
* Heart failure, NYHA class III-IV
* Uraemia, end-stage renal disease, or any other cause of impaired renal function with s-creatinine \>150 µM and/or albuminuria
* Liver disease (alanine amino transferase (ALAT) and/or aspartate amino transferase (ASAT) \>2 x upper normal serum levels)
* Anaemia
* Acute or chronic pancreatitis
* Struma or thyroid cancer
* Pregnancy or breast feeding
* Inability to complete the study

Primary outcomes:
measure: PASI (psoriasis area and severity index)
timeFrame: Baseline and after 2 months
measure: DLQI (dermatology life quality index)
timeFrame: Baseline and after 2 months
Secondary outcomes:
measure: Body mass index
timeFrame: Baseline and after 2 months
measure: CRP
timeFrame: Baseline and after 2 months
measure: Skin biopsies
timeFrame: Baseline and after 2 months
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Gentofte Hospital
Study officials:
affiliation: Gentofte Hospital
name: AnneSofie Faurschou, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06059469: PSMA-PET/CT to Assess the Expression of Specific Membrane Antigen (PSMA) in Patients With Progressive Triple-negative Breast Cancer.
Official title: PRISMA: A Single-centre, Prospective Phase II Imaging Study Using PSMA-PET/CT to Assess the Expression of Specific Membrane Antigen (PSMA) in Patients With Progressive Triple-negative Breast Cancer.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: TNBC - Triple-Negative Breast Cancer
Lead sponsor: Jules Bordet Institute
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a descriptive, prospective, single centre study. This study will assess PSMA expression via the uptake of radiolabelled PSMA-ligand using PET/CT imaging in mTNBC lesions pre-identified on 18F-FDG PET/CT in order to evaluate the feasibility of molecular radionuclide therapy in refractory mTNBC using the Lutetium-177 radiolabelled PSMA.


Eligibility criteria: Inclusion Criteria:

* Written informed consent in accordance with institutional guidelines and obtained prior to any study procedure
* Women with ≥ 18 years-old
* Eastern Cooperative Oncology Group Performance Status of 0 to 2
* Confirmed diagnosis of progressive metastatic TNBC and presenting measurable disease on 18F-FDG PET/CT (performed within 2 weeks) or Brain MRI in case of progressive brain metastases (performed within 4 weeks) prior to PSMA PET/CT.
* Radiolabelled PSMA PET/CT has to be performed before the next treatment line initiation

Exclusion Criteria:

* Pregnant or lactating patients
* Other active neoplastic disease
* Treatment by another molecule that is the object of investigation within 30 days
* Skin only metastatic disease
* Patients with a significant medical, neuro-psychiatric, or surgical condition, which, in the investigator's opinion, may interfere with completion of the study

Primary outcomes:
measure: Assess PSMA expression in progressive metastatic TNBC patients
timeFrame: once at baseline prior to the start of the new anti cancer treatment
Secondary outcomes:
measure: Assess the concordance between lesions visualized on PSMA PET/CT and 18F-FDG PET/CT images (or brain MRI in case of brain metastases).
timeFrame: once at baseline prior to the start of the new anti cancer treatment
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Institut Jules Bordet
Study officials:
References:
Clinical trial NCT01808469: First in Human Study of an Anti-Toll-like Receptor 4 (TLR4) Monoclonal Antibody (NI-0101) in Adult Healthy Volunteers
Official title: A Randomized, Double Blind, Placebo-controlled, Pharmacokinetics/Pharmacodynamics-guided, Phase I Study in Healthy Volunteers Given Escalating, Single Intravenous Doses of NI-0101 in the Absence and Then in the Presence of a Systemic Lipopolysaccharide Challenge.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Light Chain Bioscience - Novimmune SA
Sponsor class: INDUSTRY
First posted: 2013-03-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety, tolerability and distribution and elimination of a novel therapeutic drug when administered to Healthy Volunteers. In addition its effects on some inflammatory parameters will be measured in presence or absence of lipopolysaccharide stimulation.


Eligibility criteria: Inclusion Criteria:

* Healthy adults between 18 and 40 years old (inclusive) having a body mass index (BMI) between 18 and 30 kg/m2 (inclusive), able to adhere to study protocol requirements and having signed informed consent.

Exclusion Criteria:

* Any abnormal past or present clinically relevant medical history or any relevant abnormal laboratory parameters at screening that will prevent to consider the volunteers as healthy for the study.

Primary outcomes:
measure: Safety and tolerability of NI-0101 in healthy male/female subjects
timeFrame: Up to 8 weeks
Secondary outcomes:
measure: Pharmacokinetic parameters of NI-0101
timeFrame: Up to 8 weeks
measure: Pharmacodynamic parameters of NI-0101
timeFrame: Up to 8 weeks
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Centre for Human Drug Research
Study officials:
affiliation: Centre for Human Drug Research, Leiden, The Netherlands
name: J. Koos Prof. Burggraaf, MD, Ph
role: PRINCIPAL_INVESTIGATOR
References: