louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06818487: Ganyan-1 in Dry Eye
Official title: Ganyan-1 in Dry Eye: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dry Eye
TCM
Keywords: Dry eye
TCM
RCT
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 232
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: TREATMENT

Brief summary: Ganyan -1 for the patients with dry eye

Detailed description: Objective: Ganyan-1 for the patients with dry eye Methods: The investigators enrolled 232 patients at Beijing Tongren Hospital. Patients completed questionnaires at baseline, week2, week4, week8, week12, and week16.

Eligibility criteria: Inclusion Criteria:

1. Age \>=18 and Age \<=70, complaint of DED symptoms for 6 months or longer at screening.

3. ocular surface disease index (OSDI) score of 25 or higher. 4. tear film breakup time (TFBUT) of 5 seconds or less. 5. Schirmer I test without anesthesia of 5 mm or more at 5 minutes. 6. CFS score of 4 or higher.

Exclusion Criteria:

1. History systemic autoimmune diseases and ocular/periocular malignancy.
2. Clinically relevant slitlamp findings or abnormal lid anatomy.
3. Active ocular allergies and active infection.
4. Pregnant or lactating women.

Primary outcomes:
measure: OSDI
timeFrame: Baseline, week 2, 4, 8, 12 and 16
Secondary outcomes:
measure: TBUT
timeFrame: Baseline, week 2, 4, 8, 12 and 16
measure: Schirmer
timeFrame: Baseline, week 2, 4, 8, 12 and 16
measure: SF-36
timeFrame: Baseline, week 2, 4, 8, 12 and 16
measure: SAS
timeFrame: Baseline, week 2, 4, 8, 12 and 16
measure: SDS
timeFrame: Baseline, week 2, 4, 8, 12 and 16
measure: OQAS II
timeFrame: Baseline, week 2, 4, 8, 12 and 16
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05249387: Characterization of Bovine Adrenal Medulla as a New Surrogate Model of Non-histaminergic Itch
Official title: Characterization of Bovine Adrenal Medulla (BAM8-22) as a New Surrogate Model of Non-histaminergic Itch
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Itch
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2022-02-21
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: With this experiment, the experimenter wish evaluate the role of TRPA1 on non-histaminergic itch induced by BAM8-22

Detailed description: With this experiment, the experimenter wish evaluate the role of TRPA1 on non-histaminergic itch induced by BAM8-22 2 (Bovine Adrenal Medulla), which is found naturally in the human body and which has proved to evoke itch. To evaluate the role of TRPA1 it will be used a TRPA1 antagonist (A-967079)

Eligibility criteria: Inclusion Criteria:

* Healthy men and women
* 18-60 years
* Speak and understand English

Exclusion Criteria:

* Pregnancy or lactation
* Drug addiction defined as any use of cannabis, opioids or other drugs
* Previous or current history of neurological, dermatological, immunological musculoskeletal, cardiac disorder or mental illnesses that may affect the results (e.g. neuropathy, muscular pain in the upper extremities, etc.)
* Moles, wounds, scars or tattoos in the area to be treated or tested
* Lack of ability to cooperate •
* Current use of medications that may affect the trial such as antihistamines and pain killers.
* Skin diseases
* Consumption of alcohol or painkillers 24 hours before the study days and between these - Acute or chronic pain •
* Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical trials)

Primary outcomes:
measure: superficial blood perfusion
timeFrame: change from baseline, up to 10 minutes after the application
measure: Warm Detection Threshold, and Heat Pain threshold
timeFrame: change from baseline, up to 10 minutes after the application
measure: Cold Detection Threshold and Cold Pain threshold
timeFrame: change from baseline, up to 10 minutes after the application
measure: Pain supra-threshold heat Stimuli
timeFrame: change from baseline, up to 10 minutes after the application
measure: Alloknesis
timeFrame: change from baseline, up to 10 minutes after the application
measure: mechanical pain threshold and sensitivity
timeFrame: change from baseline, up to 10 minutes after the application
measure: itch rating
timeFrame: change from baseline, up to 10 minutes after the application
Secondary outcomes:
measure: pain rating
timeFrame: change from baseline, up to 10 minutes after the application
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Giulia Erica Aliotta
Study officials:
References:
Clinical trial NCT00778687: Heart Rate Variability Change After Liver Transplantation
Official title: Effects of Liver Transplantation on the Heart Rate Variability in Patients With End-Stage Liver Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Transplantation
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2008-10-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with end stage liver disease undergoing liver transplantation

Brief summary: Cirrhotic cardiomyopathy describes a hyperdynamic state with the presentation of high cardiac output and low systemic vascular resistance. And the latent heart failure becomes obvious under physiologic and pharmacologic stress. The goal of our study is to assess the effects of liver transplantation on the heart rate variability in patients with end stage liver disease.


Eligibility criteria: Inclusion Criteria:

* Age:18-70y/o receiving liver transplantation

Exclusion Criteria:

* History of cardiovascular disease

Primary outcomes:
measure: Multiscale entropy
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
citation: Genovesi S, Prata Pizzala DM, Pozzi M, Ratti L, Milanese M, Pieruzzi F, Vincenti A, Stella A, Mancia G, Stramba-Badiale M. QT interval prolongation and decreased heart rate variability in cirrhotic patients: relevance of hepatic venous pressure gradient and serum calcium. Clin Sci (Lond). 2009 May 14;116(12):851-9. doi: 10.1042/CS20080325.
Clinical trial NCT04568187: Cryolipolysis Induced Gluteal Fat Change
Official title: Clinical Efficacy of Fat Reduction on the Thigh of Korean Women Through Cryolipolysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Weight Changes
Keywords: fat
cryolipolysis
Women
femoral fat
Lead sponsor: Wonik Trade Company, Korea
Sponsor class: INDUSTRY
First posted: 2020-09-29
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: the sequential split-body trials
Primary purpose: TREATMENT

Brief summary: There was no difference in efficacy in removal of local fat on thigh by cryolipolysis through Zeltiq machine.

Cryolipolysis was found to be safe for 12 week clinical trial.

Detailed description: this study is conducted to investigate the clinical efficacy and safety of cryolipolysis on fat removal of thigh through cryolipolysis.

Healthy premenopausal volunteered women had been conducted to assess their anthropometrical, social, and cardio-metabolic, and femoral fat amount by computer tomography, and adverse events at initial, 4 week, 12 week visit.

Eligibility criteria: Inclusion Criteria:

* pre-menopausal healthy women
* subjects with body mass index ≥ 18
* subjects with visible fat on both thigh
* subjects to understand and agree to this study protocol

Exclusion Criteria:

* subjects with cryoglobulinemia, cold urticaria, or paroxysmal cold hemogobulinemia
* subjects with pregnancy or lactation within 6 months or next 3 months
* subjects with any laboratory, or metabolic abnormalities
* uncooperative subjects to comply with the study protocol
* women taking any medication/ over the counter/herbal supplements to regulate weight or fat mass over 6 months
* subjects with menstrual irregularities
* subjects to change over 10% of the former weight within the past 6 months - any procedure such as liposuction, or another surgical procedure or mesotherapy to reduce fat within 6 months
* subjects with any dermatologic abnormalities on the target areas (thigh)
* subjects with any injection into the area of intended treatment (e.g. cortisone) within 6 months

Primary outcomes:
measure: The change of girths in both thighs
timeFrame: 4 weeks
measure: The change of fat amounts in both thighs
timeFrame: 4 weeks
Secondary outcomes:
measure: The change of girths in both thighs
timeFrame: 12 weeks
measure: The change of fat amounts in both thighs
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Bariatric clinic/Family medicine, Hong-Ik General Hospital
Study officials:
affiliation: Hongik General Hospital
name: Kyu R Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03656887: Screening for Hypoglycemia in an Institutionalized Elderly Diabetic Population.
Official title: Screening for Hypoglycemia in an Institutionalized Elderly Diabetic Population.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Old Age
Institutionalized in EHPAD (French Nursing Home)
Diabetes
Hypoglycemic Syndrome
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2018-09-04
Enrollment: 29
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient institutionalized in EHPAD

Brief summary: Diabetes is a major public health problem that has been growing steadily in recent years. Its prevalence is very high in the elderly, in whom there is an increased risk of hypoglycemia.

Hypoglycaemia in elderly diabetics has serious consequences:

* increased mortality,
* increased cardiovascular morbidity,
* increased risk of falling,
* impairment of quality of life.
* Hypoglycaemia is also a risk factor for dementia in type 2 diabetes. The frequency of asymptomatic and atypical hypoglycemia has been shown to be greater in the elderly, but the exact prevalence of hypoglycemia in the elderly remains unknown.

Elderly diabetic patients in institutions are particularly fragile and have more frequent cognitive problems than non-diabetic subjects. A study conducted in this population of patients showed that a third of them had HbA1C \<6.5%, which suggests a higher frequency of hypoglycemia though the figures were not available.

We therefore decided to conduct a study to assess the frequency of hypoglycemia in order to better understand the contributing factors and to improve the management of this fragile population.


Eligibility criteria: Inclusion Criteria:

* written consent
* diabetic patient receiving treatment which could result in hypoglycemia: insulin and/or sulfonamide and/or glinides
* institutionalized patient in an EHPAD
* patient over 60 years of age

Exclusion Criteria:

- person not affiliated to a national health insurance

Primary outcomes:
measure: Number of hypoglycemic events (<70 mg/dl) demonstrated by continuous interstitial glucose monitoring over the study period.
timeFrame: Day 14
measure: Number of hypoglycemic events (<70 mg/dl) detected by capillary blood glucose measurement or clinical signs suggestive of hypoglycemia.
timeFrame: Day 14
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourogne
Study officials:
References:
Clinical trial NCT02117687: A Safety and Efficacy Study of OPTIVE FUSION™ With VISMED® Multi for the Management of Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2014-04-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of OPTIVE FUSION™ compared to VISMED® Multi for the management of dry eye.


Eligibility criteria: Inclusion Criteria:

* Use of artificial tears for dry eye in both eyes for at least 3 months
* Use of preservative-free artificial tears at least twice daily for 2 weeks;

Exclusion Criteria:

* Cataract, laser-assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK) surgery in the last 12 months
* Use of punctal plugs or contact lenses in the last month
* Active ocular allergy within last 2 years
* Best corrected visual acuity (BCVA) less than 20/200 in either eye

Primary outcomes:
measure: Change From Baseline in Global Ocular Staining Score in the Study Eye
timeFrame: Baseline, Day 35
Secondary outcomes:
measure: Change From Baseline in Global Ocular Staining Score in the Study Eye
timeFrame: Baseline, Month 3
measure: Change From Baseline in Ocular Surface Disease Index© (OSDI) Score
timeFrame: Baseline, Day 35
measure: Change From Baseline in the Schirmer Test in the Study Eye
timeFrame: Baseline, Day 35
measure: Subject Assessment of Dry Eye Symptoms on a 5-Point Scale
timeFrame: Baseline, Day 35, Month 3
measure: Subject Global Assessment of Treatment Efficacy on a 5-Point Scale
timeFrame: Baseline, Day 35, Month 3
measure: Subject Assessment of Treatment Acceptability on a 5-Point Scale
timeFrame: Day 35
measure: Investigator Global Assessment of Treatment Efficacy on a 4-Point Scale
timeFrame: Day 35, Month 3
measure: Change From Baseline in Tear Break-up Time (TBUT) in the Study Eye
timeFrame: Baseline, Day 35
measure: Work Productivity and Activity Impairment Questionnaire Score
timeFrame: Baseline, Day 35, Month 3
measure: Change From Baseline in Corneal Staining in the Study Eye
timeFrame: Baseline, Day 35, Month 3
measure: Change From Baseline in Conjunctival Staining in the Study Eye
timeFrame: Baseline, Day 35, Month 3
measure: Conjunctival Hyperaemia in the Study Eye
timeFrame: Baseline, Day 35, Month 3
measure: Study Product Use
timeFrame: Day 8, Day 35, Month 3
Other outcomes:
Locations:
city: Paris
country: France
city: London
country: United Kingdom
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Labetoulle M, Chiambaretta F, Shirlaw A, Leaback R, Baudouin C. Osmoprotectants, carboxymethylcellulose and hyaluronic acid multi-ingredient eye drop: a randomised controlled trial in moderate to severe dry eye. Eye (Lond). 2017 Oct;31(10):1409-1416. doi: 10.1038/eye.2017.73. Epub 2017 Apr 28.
Clinical trial NCT05745987: Smallpox Vaccine for Mpox Post-Exposure Prophylaxis: a Cluster RCT
Official title: SMART (Smallpox Vaccine for Mpox Post-Exposure Prophylaxis: a Cluster Randomized Controlled Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Monkeypox
Keywords: mpox
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2023-02-27
Enrollment: 1560
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each group will be randomly selected to receive the smallpox vaccine or the typhoid vaccine
Primary purpose: PREVENTION

Brief summary: A cluster randomized controlled trial to determine if smallpox vaccine reduces secondary cases and symptom severity in persons exposed to mpox.

Detailed description: A pragmatic, adaptive, multi-site, cluster randomized trial where households with one or more persons confirmed to have mpox will be randomized to smallpox vaccine or control. The co-primary outcomes are RT-PCR confirmed mpox and symptom severity.

Eligibility criteria: Inclusion Criteria:

1. Household member of person with laboratory confirmed mpox
2. Age ≥ 2 years
3. Within 14 days of onset of illness in mpox index case

Exclusion Criteria:

1. Pregnancy
2. Breastfeeding
3. Past serious allergic reaction to study vaccine components
4. Previous smallpox vaccination
5. Current or planned use of another investigational drug at any point during study participation

Primary outcomes:
measure: PCR-confirmed Mpox
timeFrame: 4 weeks
measure: Symptom severity
timeFrame: 4 weeks
Secondary outcomes:
measure: Resolution of skin lesions
timeFrame: 8 weeks
measure: Number of skin lesions
timeFrame: 8 weeks
measure: Self-reported Quality of Life
timeFrame: 8 weeks
measure: Mpox complications
timeFrame: 8 weeks
measure: Mpox Pain
timeFrame: 8 weeks
measure: Hospitalization
timeFrame: 8 weeks
measure: Mortality
timeFrame: 8 weeks
Other outcomes:
measure: Safety (SAEs, AESI)
timeFrame: 6 months
Locations:
city: Kinshasa
country: Congo, The Democratic Republic of the
facility: Catholic University of Bukavu
state: Bukavu
city: Abuja
country: Nigeria
facility: Federal Medical Center
city: Abuja
country: Nigeria
facility: University of Abuja Teaching Hospital
city: Ibadan
country: Nigeria
facility: University of Ibadan
city: Irrua
country: Nigeria
facility: Irrua Specialist Teaching Hospital
city: Kano
country: Nigeria
facility: Aminu Kano Teaching Hospital
city: Lagos
country: Nigeria
facility: Lagos University Teaching Hospital
city: Okolobiri
country: Nigeria
facility: Niger Delta Teaching Hospital
city: Port Harcourt
country: Nigeria
facility: University of Port Harcourt Teaching Hospital
city: Kampala
country: Uganda
facility: Makerere University Lung Institute
Study officials:
affiliation: McMaster University
name: Mark Loeb, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02190487: Incidence and Risk Factors of Acute Kidney Injury After Thoracic Aortic Surgery Due to Dissection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dissection of Thoracic Aorta
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-07-15
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who had thoracic aortic surgery due to dissection

Brief summary: Acute kidney injury (AKI) is one of the most frequently encountered and prognostically significant complications after cardiovascular surgery. However, there is no definitive treatment to intervene after development of AKI, therefore, preventive strategy has been the major issue. By this time, incidence of AKI after cardiovascular surgery has been reported 3-50% based on the studies with various definition of AKI and different patient cohorts. Development of unified definition for AKI in the early 2000s opened a new era in AKI study.

According to the previous studies, aortic surgery, especially thoracic aortic surgery was known to be highly prevalent of AKI, which was considered to be caused by use of total circulatory arrest (TCA), relatively high number of emergency cases, combined malperfusion syndrome before surgery and relatively complicated surgical procedure. However, there has not been many studies of AKI in thoracic aortic surgery because of its low incidence and urgent clinical presentation of aortic pathology, which hinder large randomized controlled study. Moreover, there are conflicting reports of incidence and risk factors of AKI after thoracic aortic surgery, no conclusive result has been made. Therefore, this study was designed to investigate the incidence and risk factors after thoracic aortic surgery only due to dissection.


Eligibility criteria: Inclusion Criteria:

* thoracic aortic surgery due to dissection

Exclusion Criteria:

* chronic kidney disease on renal replacement therapy before surgery
* death during or within 24 hours after surgery

Primary outcomes:
measure: incidence of acute kidney injury based of RIFLE criteria
timeFrame: upto 7 days after surgery
Secondary outcomes:
measure: Risk factors of acute kidney injury
timeFrame: after diagnosis of acute kidney injury after operation (usually within 7 days after operation)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
Study officials:
affiliation: Yonsei University
name: Yon Hee Shim
role: STUDY_DIRECTOR
References:
Clinical trial NCT04020887: Telemedicine Control Tower for the Post-Anesthesia Care Unit
Official title: A Proof-of-concept Observational Study Evaluating the Acceptability and Utility of a Telemedicine Solution for the Post Anesthesia Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elective Surgery
Keywords: Telemedicine
Post Anesthesia Care Unit (PACU)
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2019-07-16
Enrollment: 560
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The first phase is an observation phase and the next phase is an interaction phase.
Primary purpose: OTHER

Brief summary: A single center prospective before-and-after proof-of-concept study to evaluate a telemedicine center for the PACU.

Detailed description: A proof-of-concept study in perioperative telemedicine that aims to demonstrate the (i) acceptability and (ii) utility of integrating telemedicine into the PACU environment. This proof-of-concept study will be conducted in the PACU.

Eligibility criteria: Adults (age ≥ 18) undergoing elective surgery at Barnes Jewish Hospital in St. Louis, Missouri will be enrolled

Primary outcomes:
measure: Difference in Time to PACU Discharge Determination From Observation to Interaction Phase
timeFrame: up to 1 day
Secondary outcomes:
measure: Demonstrate the Potential Ability of a Remote Telemedicine Center for the PACU to Assist With PACU Functions.
timeFrame: up to 1 day
measure: Detection of Physiological Derangements in PACU Patients
timeFrame: approximately 1 day
measure: Identification of Symptoms Requiring Treatment in PACU Patients
timeFrame: approximately 1 day
measure: Recognition of Situations Requiring Emergency Medical Intervention
timeFrame: approximately 1 day
measure: Determination of Patient Readiness for PACU Discharge
timeFrame: approximately 1 day
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Michael S Avidan, MBBcH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Budelier TP, King CR, Goswami S, Bansal A, Gregory SH, Wildes TS, Abraham J, McKinnon SL, Cooper A, Kangrga I, Martin JL Jr, Milbrandt M, Evers AS, Avidan MS. Protocol for a proof-of-concept observational study evaluating the potential utility and acceptability of a telemedicine solution for the post-anesthesia care unit. F1000Res. 2020 Oct 20;9:1261. doi: 10.12688/f1000research.26794.1. eCollection 2020.