louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06546059: Gasdermin D Expression in Generalized Vitiligo Patients After Narrow-band Ultraviolet B Therapy
Official title: Gasdermin D Expression in Generalized Vitiligo Patients After Narrow-band Ultraviolet B Therapy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Vitiligo, Generalized
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 40
Sex: ALL
Minimum age (years): 10
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to:

1. Evaluate the role of tissue Gasdermin D expression using immunehistochemstry techniques in patients with generalized vitiligo and compare it with healthy controls.
2. Evaluation expression of tissue Gasdermin D using immunehistochemstry techniques in patients with generalized vitiligo after narrow band ultraviolet B therapy.
3. Determine whether there is a relationship between Gasdermin D levels and disease duration and involved body surface area (VISA) in vitiligo patients.

Detailed description: The aim of this study is to:

1. Evaluate the role of tissue Gasdermin D expression using immunehistochemstry techniques in patients with generalized vitiligo and compare it with healthy controls.
2. Evaluation expression of tissue Gasdermin D using immunehistochemstry techniques in patients with generalized vitiligo after narrow band ultraviolet B therapy.
3. Determine whether there is a relationship between Gasdermin D levels and disease duration and involved body surface area (VISA) in vitiligo patients.

Eligibility criteria: Inclusion Criteria:

* Patients with stable vitiligo of 6 months duration,
* Both sex and ages(10-75)

Exclusion Criteria:

* pregnancy,
* lactation,
* patients under or previous phototherapy,
* patients on other immunosuppressives,
* patients receiving topical or systemic therapy like antioxidants and vitamins were kept off treatment for 2 weeks prior to recruitment into the study.

Primary outcomes:
measure: Evaluate the role of tissue Gasdermin D expression using immunehistochemstry techniques in patients with generalized vitiligo and compare it with healthy controls.
timeFrame: three months
Secondary outcomes:
measure: 2- Evaluation expression of tissue Gasdermin D using immunehistochemstry techniques in patients with generalized vitiligo after narrow band ultraviolet B therapy.
timeFrame: three months
measure: 3- Determine whether there is a correlation between tissue immunehistochemstry Gasdermin D levels and disease duration and involved body surface area (VISA) in vitiligo patients.
timeFrame: three months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02809859: CPAP In-home Assessment USA
Official title: CPAP In-home Assessment USA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
First posted: 2016-06-22
Enrollment: 139
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is to evaluate the product reliability, therapy effectiveness and user feedback of a Continuous Positive Airway Pressure (CPAP) device in-home for up to 6 months.

Detailed description: Existing and Naïve CPAP users will be recruited into a 6 month in-home study Participants will attend 5 study visits at day 0, 7, 30, 60 and 180. Outcome of the clinical investigation include downloadable device data reports, device error reports and participants perception questionnaires.

Eligibility criteria: Inclusion Criteria:

* Aged 22 and over
* Diagnosed with Obstructive Sleep Apnea (OSA) and prescribed Positive Airway Pressure (either Continuous positive airway pressure (CPAP) or AutoCPAP)
* For experienced users of PAP (CPAP or AutoCPAP) - you must be using PAP of more than 4 hours/night for 70% during the last 30 days.

Exclusion Criteria:

* Contraindicated for PAP (CPAP or AutoCPAP) therapy
* Has other significant sleep disorders (e.g periodic leg movements, insomnia, central sleep apnea)
* Has obesity hypoventilation syndrome or congestive heart failure
* Requires supplemental oxygen with their PAP (CPAP or AutoCPAP) device
* Has implanted electronic medical devices (e.g cardiac pacemakers)
* Pregnant or think they may be pregnant
* Not fluent in spoken and written English.

Primary outcomes:
measure: Apnea Hypopnea Index (AHI), Measured as Number of Events/Hour.
timeFrame: 6 months
measure: Log of Safety Related Events, Measured as Number of Participants That Experienced Unacceptable Safety Related Faults
timeFrame: 6 months
measure: Machine Reported Faults, Measured as Number of Patients With Machine Faults
timeFrame: 6 months
measure: Participant Reported Faults, Measured as Number of Participant Complaints
timeFrame: 6 months
Secondary outcomes:
measure: How Many Participants Slept Acceptably, Well or Very Well Throughout the Night on the CPAP Device
timeFrame: 6 months
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Alabama Sleep Clinic
state: Alabama
city: Kissimmee
country: United States
facility: Pulmonary Disease Specialists - Central Florida Sleep Centre
state: Florida
city: Saint Louis
country: United States
facility: Clayton Sleep Institute
state: Missouri
city: Dublin
country: United States
facility: Ohio Sleep Medicine and Neurosciences Institute
state: Ohio
Study officials:
affiliation: Clayton Sleep Institute
name: Matt Uhles
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06787859: Investigation of the Effect of "Curtain" Use on Self-Injection, Testing Fear and Pain in Patients With Type 2 Diabetes
Official title: Investigation of the Effect of "Curtain" Use on Self-Injection, Testing Fear and Pain in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes Mellitus 2
Insulin Dependent Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus, insulin, fear, pain,
curtain
Self-Injection
Lead sponsor: Dicle University
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 100
Sex: ALL
Minimum age (years): 15
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: study group and control group
Primary purpose: TREATMENT

Brief summary: Diabetes is a global problem for the world and negatively affects life (1). The most important reasons for ineffective diabetes and insulin treatment include fear of insulin side effects, fear of insulin injection, social embarrassment from administering insulin, fear of hypoglycemia and/or hyperglycemia (2). A large portion of diabetic individuals experience these fears, and some of these patients cope with these fears and integrate them into their daily lifestyles. However, some diabetic patients may be ineffective in coping with these fears (3). This situation creates negativities in the individual's success in treatment and compliance with treatment (3). Diverting attention is one of the non-pharmacological methods used in pain control. Diverting attention is one of the most preferred methods in reducing the pain experienced by patients during diagnosis and treatment procedures. It is a method that allows patients to control and reduce their symptoms by focusing their attention on a different point (4). In this study, the use of a distracting curtain during self-injection in individuals with Type 2 diabetes will be examined in order to examine the effect of pain and fear.

Detailed description: Research Type:

It is designed as a randomized controlled, regular research.

Research Universe and Samples:

The research groups will be the living diabetes cells of Dicle University Hospitals. The research aims to create 100 healthy diabetes patients in Dicle University Hospital.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes for at least one year
* self-administering insulin injections
* self-administering a glucometer, insulin pen or insulin pump,

Exclusion Criteria:

* poor mental health
* Having gestational diabetes mellitus or Type 1 Diabetes

Primary outcomes:
measure: Visual Analogue Scale -VAS
timeFrame: Before insulin administration on day one Time Frame: After two insulin administration on the second day
Secondary outcomes:
measure: Diabetes Fear of Self Injecting and Self-testing Questionnaire-D-FISQ
timeFrame: Before insulin administration on day one Time Frame: After two insulin administration on the second day
Other outcomes:
Locations:
city: Diyarbakır
country: Turkey
facility: Dicle Univertsity
state: South East
Study officials:
References:
Clinical trial NCT01361659: Shockwave Treatment for Advanced Angina in Maastricht
Official title: Shockwave Treatment for Advanced Angina in Maastricht (SWAAM-study).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Angina
Keywords: anginal complaints
Lithotripsy
no option patients
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Medispec ltd.
First posted: 2011-05-27
Enrollment: 60
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: There is an increasing number of patients with a coronary anatomy that does not allow additional revascularization procedures, while the patients suffer from angina pectoris at rest or at minimal exercise levels despite optimised medical therapy. There is a lack of therapeutic options for this group of so called "no-option patients". Goal of the project is to implement the shockwave therapy for no-option coronary artery disease patients and to evaluate its potential benefit on regional myocardial perfusion, on regional myocardial function and on the potential improvement in symptoms and quality of life.


Eligibility criteria: Inclusion Criteria:

* Chronic angina pectoris CCS (Canadian Cardiological Society) III or IV with documented reversible ischemia and/or hibernation.
* Patients demonstrates exercise tolerance test (ETT) duration \< 10 minutes on a modified Bruce protocol
* No possibility of traditional revascularization by coronary artery bypass grafting (CABG) or Percutaneous coronary intervention (PCI)
* Patient's conditions stable for at least 3 months
* Life expectancy of \> 12 months.

Exclusion Criteria:

* Unstable angina pectoris
* Haemodynamically significant valvular heart disease
* Myocardial infarction \<3 month prior randomization
* Evidence of intracardiac thrombus
* Contraindication for Magnetic resonance imaging (MRI) (pacemaker, metallic prostheses)
* Patient is simultaneously participating in another device or drug study, or has participated in any clinical trial involving an experimental device or drug, including other drugs or devices enhancing cardiac neovascularization or any Extracorporeal Shock Wave Therapy (ESWT) machine for neovascularization of a competitor company within 3 months of entry into the study.
* Patients who are unwilling or unable to cooperate with the study procedure.
* Age \< 18 years
* Cardiac or pulmonary malignancy
* No informed consent
* Known depression

Primary outcomes:
measure: Improvement of exercise tolerance
timeFrame: after 6 months
Secondary outcomes:
measure: Improvement of myocardial perfusion
timeFrame: 6 months
measure: Number of Patients with Adverse Events as a Measure of Safety
timeFrame: 6 months
measure: Improvement of quality of life
timeFrame: 6 months
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: H. Crijns, Prof Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05190159: Monster Screw System Post-Market Clinical Follow-Up Study
Official title: Monster Screw System Post-Market Clinical Follow-Up Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankle Injuries
Foot Injury
Lead sponsor: Paragon 28
Sponsor class: INDUSTRY
First posted: 2022-01-13
Enrollment: 82
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigational population will include subjects who have undergone a foot and/or ankle procedure that fulfill the eligibility criteria

Brief summary: Post-market clinical follow-up study on the Monster Screw System

Detailed description: Ambispective, multi-surgeon, single site, consecutive case series to determine the safety, performance, and benefits of the Monster Screw System.

Eligibility criteria: Inclusion Criteria:

* The subject has undergone a foot and/or ankle procedure using the Monster Screw System and completed by one of the investigators.
* The subject has adequate radiographic and medical records

For the Prospective Data Collection:

- The subject is willing to provide written informed consent

Exclusion Criteria:

-None

Primary outcomes:
measure: Incidence of secondary procedures
timeFrame: Up to 9 months
measure: Incidence of adverse events
timeFrame: Up to 9 months
Secondary outcomes:
measure: Rate of Nonunion
timeFrame: Up to 9 months
measure: Rate of Maintenance of Correction
timeFrame: Up to 9 months
measure: Rate of Index Device Failure
timeFrame: Up to 9 months
measure: Foot and Ankle Mobility Measure
timeFrame: Up to 54 months
measure: Visual Analog Scale
timeFrame: Up to 54 months
measure: Patient satisfaction
timeFrame: Up to 54 months
Other outcomes:
Locations:
city: Jackson
country: United States
facility: Henry Ford Health Systems
state: Michigan
Study officials:
affiliation: Paragon 28
name: Jacy Legue
role: STUDY_DIRECTOR
References:
Clinical trial NCT01632059: Examination of ADMA Serum Level and DDAH II
Official title: Examination of ADMA (Asymmetric-dimethylarginine)-Serum Level and DDAH II (Dimethylarginine Dimethylaminohydrolase)- Polymorphism in Patients With Severe Sepsis and Septic Shock as Prognostic Value
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Septic Shock
Sepsis
Keywords: ADMA
DDAH II
SAPS
SOFA
Sepsis
Procalcitonin
ICU
mortality
length of stay
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2012-06-29
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients \> 18 y/o with sepsis and/or septical shock

Brief summary: Examination of ADMA (Asymmetric-Dimethylarginine)-serum level and DDAH II (Dimethylarginine Dimethylaminohydrolase)- Polymorphism in patients with severe Sepsis and septic shock as prognostic value.

This study looks into ADMA as a good prognostic factor for sepsis. Further more the dependency of the ADMA level to the DDAH II polymorphisms is reviewed this study.

Detailed description: Secondary targets are the mortality (28 days ICU), the length of hospitalisation in ICU and peripheral station, the severity of the illness (SAPS II score), the SOFA-score values in the progress and the procalcitonin values in the progress

Eligibility criteria: Inclusion Criteria:

* \>18 y/o
* sepsis
* septical shock

Exclusion Criteria:

* primary cardiogenic shock
* pregnancy
* breastfeeding
* non compliance
* moribund status

Primary outcomes:
measure: ADMA serum levels
timeFrame: 7 days
Secondary outcomes:
measure: 28 day mortality
timeFrame: 28 day
measure: hospitalisation (ICU and peripheral)
timeFrame: 28 days
measure: severity of illness
timeFrame: 28 days
measure: DDAH Ii polymorphism
timeFrame: 28 days
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Universitätskrankenhaus Hamburg Eppendorf
Study officials:
affiliation: Director of critical care center
name: Stefan Kluge, Priv.-Doz.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04297059: The Ajyal Salima Longitudinal Study to Prevent Childhood Obesity
Official title: 2-year Intervention and 1-year Follow-up of a School-based Programme to Promote Healthy Behaviours and Prevent Childhood Obesity in Lebanese Children: the Healthier Kids - Ajyal Salima Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Keywords: BMI
Health policies
School health promotion
Intervention
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2020-03-05
Enrollment: 1239
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study was carried out to determine the long-term effectiveness of a school-based intervention programme when implemented over 2 years and its sustained effect one year later.


Eligibility criteria: Inclusion Criteria:

Schoolchildren Aged 8-12 years

Exclusion Criteria:

* no exclusion criteria

Primary outcomes:
measure: Change in knowledge score
timeFrame: 3 school years
measure: Change in dietary habits
timeFrame: 3 school years
measure: Change in self-efficacy score
timeFrame: 3 school years
measure: Change in Body Mass Index
timeFrame: 3 school years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01102959: The Effectiveness of Photographic Educational Material on Carbohydrate Counting for Adolescents With Diabetes
Official title: The Effectiveness of Photographic Educational Material on Carbohydrate Counting for Adolescents With Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus
Keywords: EDUCATION
DIABETES MELLITUS
ADOLESCENT
DIABETIC DIET
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2010-04-13
Enrollment: 50
Sex: ALL
Minimum age (years): 11
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The hypothesis of this study focuses on obtaining accurate information on the effectiveness of photographic educational material on orientation of carbohydrate counting for adolescents with diabetes.

Detailed description: The adolescents with diabetes at the Pediatric Endocrinology and Diabetes outpatient clinic, will be randomly distributed between two groups: those who will receive orientation on carbohydrate counting through photographic educational material and those through a list of foods equivalent.

Research will follow 3 steps:

First, data will be collected on age, gender, BMI, HbA1C, schooling, type of educational material and parents grade level; answer sheets will be applied to evaluate previous knowledge on carbohydrate counting; orientation will be provided on counting with photo material or list.

Second, after a month of using the educational material, a quiz by phone will be conducted with the sole intent to reinforce orientation.

Third, two days later, adolescents will be directed to the experimental kitchen to see portions of real food and provide answers on amount or choice of carbohydrate.

Statistical tools will be applied to evaluate results.

Eligibility criteria: Inclusion Criteria:

* Adolescents with diabetes aged 11 years to 19 years who count carbohydrates in their diet.
* Adolescents with more than 6 years of study .
* There is no restriction ethnic, social, gender, nutrition status, type of diabetes.

Exclusion Criteria:

* Adolescents with diabetes aged 11 years to 19 years who not count carbohydrate counting in your diet.
* Adolescents with less than 6 years of study.
* Adolescents who don't want to participated in this research.

Primary outcomes:
measure: Number the answers correct or incorrect on carbohydrate counting in portions of real food
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of São Paulo General Hospital
Study officials:
affiliation: University of São Paulo General Hospital
name: Alexandre A. Ferraro, Phd
role: STUDY_CHAIR
References:
Clinical trial NCT06083259: Cyanoacrylate With or Without Suture?
Official title: Does Cyanoacrylate Require Supportive Suturing to Reduce Seconder Bleeding and Stabilizing Biomaterial at the Donor Site?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Heal
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-10-13
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An epithelialized gingival graft will be harvested from the palate for the treatment of various mucogingival deformities. The donor site will be treated with either a combination of a collagen sponge and cyanoacrylate or a collagen sponge, cyanoacrylate, and suspending sutures. Intraoperatively, measurements will be taken for palatal tissue thickness, graft dimensions, working time, and primary bleeding time. Data regarding pain perception will be gauged using a visual analog scale, and the number of analgesics, secondary bleeding, epithelization level, and color match will be assessed prospectively. These outcomes will be evaluated on the first 7 days and subsequently on the 14th, 21st, and 28th days. Patient-reported outcomes will be recorded using the Oral Health Impact Profile-14 questionnaire.


Eligibility criteria: Inclusion Criteria: Inclusion Criteria:

* age ≥18;
* mucogingival surgical treatment indication that needs connective tissue graft in the anterior mandible;
* stable periodontium after phase I therapy;
* full-mouth plaque and bleeding scores \<15%

Exclusion Criteria:

* previous palatal harvesting history;
* unstable endodontic conditions;
* tooth mobility at the surgical site;
* systemic disease;
* pregnancy;
* use of medications with potential adverse effects on periodontal tissues

Primary outcomes:
measure: Donor site pain perception
timeFrame: everyday in first week
measure: Secondary bleeding time
timeFrame: during first week
Secondary outcomes:
measure: Graft height
timeFrame: during surgery
measure: Graft width
timeFrame: during surgery
measure: Graft thickness
timeFrame: during surgery
measure: Working time
timeFrame: during surgery
measure: Quantity of analgesics
timeFrame: first week
measure: Sensation loss
timeFrame: first week, second week , third week, fourth week.
measure: Color match
timeFrame: first week, second week, third week, fourth week.
measure: Epithelization level
timeFrame: first week, second week, third week, fourth week.
measure: The Oral Health Impact Profile-14 is a questionnaire that measures how oral disorders impact a patient's quality of life.
timeFrame: first week
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References: