louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02054494: T1 Mapping in HIV Patients With High and Low CD4+ Cell Counts
Official title: Myocardial T1-mapping and T1-derived Extracellular Volume Fraction (ECV) in HIV-infection Patients With Chronic High and Low CD4+ Counts and in a Healthy Control Group
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Diseases
HIV
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2014-02-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV patients are recruted from the HIV outpatients clinic of our hospital.

Brief summary: HIV-infection is associated with an increased risk for cardiovascular disease. Especially patients with low CD4+ counts have a higher incidence of structural heart disease. Myocardial T1 relaxation time, as well as T1-derived extracellular volume fraction are relatively new methods for non-invasive myocardial tissue characterization, including diffuse myocardial fibrosis.

In our study HIV-patients with high and low CD4+ counts are examined on a 3T MRI scanner (Ingenia 3T, Philips Medical, Best, Netherlands). Scanning protocol includes common SSFP sequences, STIR imaging and LGE \[Late gadolinium enhancement\]. All HIV patients are treated in the HIV outpatient clinic of the hospital's Internal Medicine department and have an unremarkable history of cardiac disease. Patients are recruited from all over Germany. In order to obtain reference values, a subgroup of healthy, age-matched controls is included in this study.

Aim of this study is to show differences in T1- and ECV-values in the investigated subgroups. In addition, we also want to create cut-off values for healthy and affected myocardium in asymptomatic HIV-infected patients. This study could show whether myocardial T1 mapping is a potential screening parameter for beginning heart disease as part of an HIV-infection, and whether an application in routine diagnostic is reasonable.


Eligibility criteria: Inclusion Criteria:

* chronic HIV infection
* no known cardiac disease
* no cardiovascular risk factors

Exclusion Criteria:

* contraindications to MRI (e.g. metal implants)
* chronic kidney disease

Primary outcomes:
measure: Native T1 Relaxation Times
timeFrame: Measurement will be performed within 2 weeks after MRI scan
Secondary outcomes:
measure: Extracellular volume fraction (ECV)
timeFrame: Measurement will be performed within 2 weeks after MRI scan
Other outcomes:
measure: Cardiac function and aortic distensibility
timeFrame: Measurement will be performed within 2 weeks after MRI scan
Locations:
city: Bonn
country: Germany
facility: University of Bonn, Dept. of Radiology
state: NRW
Study officials:
affiliation: University of Bonn, Dept. of Radiology, Sigmund-Freud-Str. 25, 53127 Bonn, Germany
name: Claas P Naehle, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06119360: Comparison of Two Different Lightwand Intubation Techniques in Cervical Immobilized Patients
Official title: Comparison of the Intubation Success Rate Between Two Techniques Using Lightwand in Patients Undergoing Spine Surgery: Conventional vs. Face-to-face Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation; Difficult or Failed
Lead sponsor: Kyung Hee University Hospital at Gangdong
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study compares two different approaches of lightwand intubation techniques in cervical immobilized patients.

Detailed description: This study compares two approaches in lightwand intubation techniques in cervical immobilized patients. One is a conventional approach that involves scooping movement with mandible protraction. The other is a face-to-face approach that inserts lightwand with a front-facing position. This study is conducted as a randomized, prospective, single-blinded design.

Eligibility criteria: Inclusion Criteria:

* adults with American Society of Anesthesiologists physical status 1-3
* patients who received scheduled spine surgery under general anesthesia

Exclusion Criteria:

* patients with body mass index \<18.5 kg/m2 or \>35.0 kg/m2,
* patients who previously had head and neck surgery,
* patients who are at high risk of aspiration,
* patients with pathologic conditions such as tumors, polyps, or inflammation in the airway,
* patients who cannot sit due to severe spine deformity,
* patients who have compromised cardiopulmonary function patients with clinically significant neurovascular disease

Primary outcomes:
measure: Initial success rate
timeFrame: during intubation
Secondary outcomes:
measure: Intubation time
timeFrame: during intubation
Other outcomes:
measure: Immediate intubation related outcomes
timeFrame: Immediately after general anesthesia (at the post anesthesia care unit)
measure: 24 hours intubation related outcomes
timeFrame: 24 hours after general anesthesia (at the general ward)
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Gangdong Hospital
Study officials:
affiliation: Kyung Hee University Hospital at Gangdong-gu
name: Hyungseok Suh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00543660: Descemet Stripping (Automated) Endothelial Keratoplasty (DSEK or DSAEK)
Official title: Descemet Stripping (Automated) Endothelial Keratoplasty (DSEK or DSAEK)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Corneal Dystrophies, Hereditary
Keywords: Corneal transplantation, Descemet membrane, endothelium
Lead sponsor: Netherlands Institute for Innovative Ocular Surgery
Sponsor class: OTHER
Collaborators: name: Amnitrans Eyebank Rotterdam
name: Melles CorneaClinic Rotterdam
First posted: 2007-10-15
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the transplantation of a posterior corneal disc for the management of corneal endothelial disorders in Descemet Stripping Endothelial Keratoplasty (DSEK) or Descemet Stripping Automated Endothelial Keratoplasty (DSAEK).

Detailed description: Please see above.

Eligibility criteria: Inclusion Criteria:

* Corneal endothelial disorders

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Best spectacle corrected visual acuity
timeFrame: 1998 - 2018
Secondary outcomes:
measure: Corneal endothelial cell density
timeFrame: 1998-2018
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Netherlands Institute for Innovative Ocular Surgery
Study officials:
affiliation: Netherlands Institute for Innovative Ocular Surgery
name: Gerrit RJ Melles, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Melles GR. Posterior lamellar keratoplasty: DLEK to DSEK to DMEK. Cornea. 2006 Sep;25(8):879-81. doi: 10.1097/01.ico.0000243962.60392.4f. No abstract available.
Clinical trial NCT06394960: Factors Predicting Blood Pressure Change With Interscalene Block
Official title: Factors Predicting Blood Pressure Change Associated With Interscalene Block, Prospective and Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systolic Blood Pressure (20% or Greater Increase)
Keywords: Interscalene Block
Blood Pressure Change
Anterior Scalene Muscle Thickness
Hypertensive Patient
Lead sponsor: Konya City Hospital
Sponsor class: OTHER
First posted: 2024-05-01
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participating study center will be Konya City Hospital and the research population will consist of volunteer patients who will undergo elective shoulder surgery under interscalene block.

Brief summary: The primary aim of this study is to identify potential anthropometric features that predict the relationship between the Interscalene Block procedure and changes in blood pressure

Detailed description: This prospective, randomized study will be carried out after obtaining the necessary ethical approval and informed consent from the patients. 110 adult volunteer patients who will undergo ISB for shoulder surgery anesthesia will be included in this study. Evaluation of the patients before ISB and anthropometric measurements before and after Interscalene Block will be performed by an anesthesiologist who is not involved in the study.

Eligibility criteria: Inclusion Criteria:

* ASA I-III, elective shoulder surgery will be performed

Exclusion Criteria:

* Presence of advanced renal or hepatic insufficiency, serious respiratory or cardiovascular disease
* History of chronic opioid or benzodiazepine use
* Presence of allergy to the local anesthetic drugs used
* ISB contraindication (such as neurological disorder in the extremity to be operated on, diaphragmatic paralysis in the opposite region of the side where the intervention is planned, infection in the intervention area).
* Presence of high level anxiety
* Patients with a Hospital Anxiety and Depression Scale (HADS) cut-off score of 10 for the anxiety subscale and 7 or higher for the depression subscale

Primary outcomes:
measure: Our primary aim in this study is to determine possible anthropometric features that will predict the relationship between interscalene block procedure and blood pressure change.
timeFrame: 60 minute
Secondary outcomes:
measure: The secondary aim of this study is to reveal the relationship between interscalene block and heart rate.
timeFrame: 60 minute
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Konya City Hospital
state: Karatay
Study officials:
References:
Clinical trial NCT02497560: A Study To Investigate The Effect Of A Natural Dietary Supplement On Peri-Menopausal Symptoms
Official title: A Randomized Double Blind Placebo-Controlled Study To Investigate The Effect Of A Natural Dietary Supplement On Peri-Menopausal Symptoms
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Menopause
Lead sponsor: Physician Recommended Nutriceuticals
Sponsor class: INDUSTRY
First posted: 2015-07-14
Enrollment: 20
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a randomized, masked, placebo controlled study to assess the effect on a nutritional dietary supplement on menopausal signs and symptoms in perimenopausal women.


Eligibility criteria: Inclusion Criteria:

* Age group between 45 and 65 at the time of informed consent.
* Physician diagnosis of menopause.
* History of substantial hot flashes \> 4 episodes /day for last 2 weeks.
* Being post-menopausal with an intact uterus.
* Subject has provided signed and dated written informed consent before admission to the study.

Exclusion Criteria:

* Concurrent hot flash therapies (prescription medications including hormone replacement therapies, gabapentin or over the counter supplements), vaginal hormonal products (rings, creams, gels) or transdermal estrogen or estrogen/progestin products for 30 days before screening visit.
* Women currently or previously on anticoagulants, Vitamin K antagonists like warfarin in the past 3 months, or expected to be on anticoagulants in the near future.
* Women involved in other clinical studies within the last 30 days.
* Any women who, in the opinion of the principal investigator, is at poor medical or psychiatric risk for the study.

Primary outcomes:
measure: Hot flashes episodes
timeFrame: 12 weeks
Secondary outcomes:
measure: Work productivity
timeFrame: 12 weeks
measure: Quality of Life
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: Comprehensive Women's Care
state: Colorado
city: Philadelphia
country: United States
facility: Dittrich Clinic
state: Pennsylvania
Study officials:
References:
Clinical trial NCT06649760: Oral Health Education and Message Framing Effect on Oral Health Status of Refugees in Egypt
Official title: Effect of Message Framing Through M-Health on Oral Health Conditions and Oral Health Related Quality of Life Among Refugees in Alexandria, Egypt: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knowledge, Attitudes, Practice
Caries,Dental
Plaque, Dental
Gingivitis
Pocket, Periodontal
Keywords: Dental caries
Plaque
KAP
Gingivitis
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-10-21
Enrollment: 510
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: Refugees, facing forced displacement and often exposed to traumatic experiences, represent a vulnerable population with unique healthcare needs. Oral health is considered a prominent factor that contributes to quality of life.

Therefore, this study aim at assessing the effect of message framing on enhancing oral health practices in a group of refugees in Alexandria, Egypt. A three-arm cluster randomized controlled clinical trial will compare a gain-framed mobile text messages group, a loss-framed mobile text messages group, and a control group. The primary outcome is the improvement in oral health practices measured by changes in dental plaque and secondary outcome is to assess change in oral health-related quality of life. In addition, oral health knowledge, attitudes, and practices of refugees will be assessed.


Eligibility criteria: Inclusion Criteria:

* Refugees older than 18 years old.
* From Arabic speaking countries.
* Has been resident in Alexandria, Egypt for at least 6 months.
* Having mobile phones to receive text messages.
* Agrees to participate in the study.

Exclusion Criteria:

* Planning to move away during 1 year study period.
* Participating in any kind of oral health education and promotion programs.

Primary outcomes:
measure: Oral health knowledge improvement
timeFrame: Immediately after structured oral health session, 6 months and 1 year after baseline
measure: Oral health practices improvement
timeFrame: 6 months and 1 year after baseline
measure: Oral hygiene status assesment
timeFrame: 6 months and 1 year after baseline
measure: Gingival health assessment
timeFrame: 6 months and 1 year after baseline
measure: Periodontal health status
timeFrame: 6 months and 1 year after baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Caritas
Study officials:
affiliation: Alexandria University
name: Mona El Kashlan, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05043194: Ursodeoxycholic Acid Prevents Total Parenteral Nutrition Cholestasis
Official title: The Preventive Study of Ursodeoxycholic Acid(UDCA) on Total Parenteral Nutrition Cholestasis(PNAC) in Premature Infants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cholestasis of Parenteral Nutrition
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2021-09-14
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to confirm whether the preventive use of ursodeoxycholic acid on the 5th day after birth in preterm infants who started parenteral nutrition therapy can reduce the occurrence of enteral nutrition-related cholestasis in preterm infants. This study examined the safety and efficacy of ursodeoxycholic acid (UDCA) in preventing Cholestasis Associated with Total Parenteral Nutrition in preterm infants.

Detailed description: Investigators compared oral administration of UDCA prophylaxis with no prophylaxis in a randomized, open-label, proof-of-concept trial in preterm neonates with PN therapy.

Eligibility criteria: Inclusion Criteria:

1. admission to the hospital within 24 hours after birth
2. gestational ages:28-32 weeks
3. requiring TPN during the first days of life

Exclusion Criteria:

1. major congenital abnormalities, chromosomal abnormality congenital intrauterine infection, genetic metabolic diseases structural liver abnormality
2. surgical treatment was taken during hospitalization
3. with severe symptoms of digestive system disease before TPN
4. incompletion or withdrawal of treatment during hospitalization

Primary outcomes:
measure: direct bilirubin value of participants
timeFrame: up to 10 weeks
Secondary outcomes:
measure: The γ-GT activity level of participants
timeFrame: up to 10 weeks
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wei Liu
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: liwen chang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00513994: MQX-503 vs Nitroglycerin Ointment: A Pharmacokinetic Comparison in Normal Subjects
Official title: MQX-503 Applied to the Fingers vs. Nitroglycerin Ointment 2%, USP, Applied to the Chest: A Pharmacokinetic Comparison in Normal Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Pharmacokinetics
Nitroglycerin
pharmacokinetics study of nitroglycerin containing treatments
Lead sponsor: MediQuest Therapeutics
Sponsor class: INDUSTRY
First posted: 2007-08-09
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to measure how much nitroglycerin or its metabolites may be found in the bloodstream when MQX-503 or an FDA approved Nitroglycerin ointment 2% USP is applied to the skin of healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers 18 - 70 years of age.
* Subjects able to give written informed consent and comply with study requirements.
* Subjects willing and able to safely discontinue all current prescription therapies.
* Subjects who will agree not to participate in other clinical trials.
* Negative pregnancy test in fertile females and agreement to use effective contraception throughout the study.

Exclusion Criteria:

* Persons who would be put at risk by discontinuing prescription therapies.
* Subjects with a known allergy to nitroglycerin.
* Subjects who have a condition or issue that would adversely affect the application of study medication, study evaluations or the subject's ability to comply with the protocol.
* Subjects who recently experienced myocardial infarction, uncontrolled congestive heart failure, unstable angina, uncontrolled hypotension or uncontrolled hypertension.
* Subjects who have participated in a study of an investigational drug within two weeks of visit 1.
* Subjects who have screening lab values that are out of range or are considered clinically significant by the investigator.
* Subjects who have had major abdominal, thoracic, or vascular surgery within 6 months of visit 1.
* Subjects with non-epithelialized skin lesions or interfering skin conditions at the time of screening in the area where study medication is to be applied.
* Pregnant or nursing women.
* Women of childbearing potential who are unwilling to comply with the contraceptive requirements.

Primary outcomes:
measure: The primary objective is the measurement and comparison of the levels of nitroglycerin and its metabolites in the blood of healthy human volunteers after a single topical dose of MQX-503 and a single topical dose of Nitroglycerin Ointment 2%, USP.
timeFrame: 8 hours
Secondary outcomes:
measure: A secondary objective is the observation of the volunteers for any adverse events
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Tacoma
country: United States
facility: Charles River Clinical Services
state: Washington
Study officials:
affiliation: Charles River Clinical Research
name: Adel Nada, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01017094: Pin Site Infection Prevention for Open Tibial Fracture
Official title: Can Silversulfadiazine Prevent Pin-site Infection in Open Tibial Fracture?: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tibial Fracture
Keywords: Pin-site infection
silversulfadiazine
open fracture
open tibial fracture underwent external fixator
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2009-11-20
Enrollment: 30
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to compare the efficacy of pin-tract infection prevention between silversulfadiazine and dry dressing.

Methods: 30 patients with an open tibial fracture admitted to Songklanagarind hospital from September 2007 to June 2008 and treated by emergency debridement and external fixation were randomized into two groups, one treated with silversulfadiazine for infection prophylaxis (15) and a control group treated with dry dressing only (15). All patients were followed until the external fixator was removed. Pin-site infections were assessed and graded at each follow-up visit by an orthopaedist blinded to the mode of treatment. A culture from the pin site was done if an infection occurred.


Eligibility criteria: Inclusion Criteria:

* Open tibial fracture treated with external fixator age between 15-60 years

Exclusion Criteria:

* Immunocompromised patients (diabetes, HIV or malignancy)

Primary outcomes:
measure: incidence of pin site infection
timeFrame: 2 years
Secondary outcomes:
measure: type of organism
timeFrame: 2 years
measure: severity of pin site infection
timeFrame: 2 years
Other outcomes:
Locations:
city: Hat Yai
country: Thailand
facility: Prince of Songkla University
state: Songkhla
Study officials:
affiliation: Faculty of Medicine, Prince of Songkla University
name: Boonsin Tangtrakulwanich, MD.,Ph.D
role: PRINCIPAL_INVESTIGATOR
References: