louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06390644: Effect of Periorbital Massage on Dry Eye Disease
Official title: Effect of Periorbital Massage on Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dry Eye
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This randomized controlled trial aims to investigate the efficacy of periorbital massage therapy in alleviating symptoms and improving clinical outcomes in patients diagnosed with dry eye disease.

Detailed description: Participants will be randomized into either a periorbital massage intervention group or a control group receiving standard care. The intervention group will receive gentle periorbital massage techniques, while the control group will receive conventional dry eye treatments. The primary outcome measure will be assessed using the Schirmer Strips and Ocular Surface Disease Index (OSDI) questionnaire. This study holds promise for providing insights into the potential benefits of periorbital massage therapy as a complementary approach for managing dry eye disease symptoms and enhancing patients' overall quality of life.

Eligibility criteria: Inclusion Criteria:

* Symptoms of dry eye (such as burning, dryness or foreign body sensation)
* Ocular signs of dry eye (such as tear film instability, reduced tear production or meibomian gland dysfunction)
* Patients having moderate and severe dry eye disease according to schirmer test Willing and able to comply with the study protocol

Exclusion Criteria:

* Active ocular infection
* Ocular surgery within past 3 months
* Use of contact lenses
* Use of systemic medications that can affect tear production or tear quality
* Pregnancy or lactation

Primary outcomes:
measure: Schirmer Strips
timeFrame: 12 Months
Secondary outcomes:
measure: OSDI Questionnaire
timeFrame: 12 Months
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Usman Saleem Hospital and Fouzia Maternity Home Address: Usman Saleem Hospital and Fouzia Maternity Home
state: Punjab
Study officials:
References:
Clinical trial NCT00942344: Efficacy and Safety of Amlodipine and Losartan in Patients With Essential Hypertension
Official title: An 8-week, Multicenter, Randomized, Double-blind, Factorial Phase II Study to Evaluate Dose-response Relationship of Amlodipine and Losartan Combination in Patients With Essential Hypertension.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension
Keywords: Amlodipine
Losartan
Hypertension
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2009-07-20
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of fixed combination of amlodipine(5mg or 10mg) and losartan (50 mg or 100 mg), amlodipine and losartan alone in reducing blood pressure. The study will investigate the dose response relationship for the combinations and monotherapies.


Eligibility criteria: Inclusion Criteria:

* Patients aged between 18 and 75
* Patients with essential hypertension {95 mmHg ≤ sitDBP\< 115 mmHg at the end of placebo run-in treatment period}

Exclusion Criteria:

* Patients with mean sitSBP ≥ 200 mmHg
* Patients with known hypersensitivity to Dihydropyridine or angiotensin II receptor blockers
* Patients with secondary hypertension or suspected secondary hypertension
* Patients with malignant hypertension
* Patients who have received any medications with possible interactions with study drugs
* Patients with uncontrolled diabetes
* Patients with severe heart disease or severe cerebrovascular disease
* Patients with clinically significant hematological test results, renal disease (serum creatinine) or liver disease (ALT or AST)
* Patients with a history of malignant disease
* Patients with a history of autoimmune disease
* Women with a positive pregnancy test result, breast feeding or intention of pregnancy during the trial
* Patients inappropriate to be included in study population due to other reasons at the discretion of the investigator

Primary outcomes:
measure: Average changes from baseline in sitDBP
timeFrame: Week 8
Secondary outcomes:
measure: Average changes from baseline in sitDBP
timeFrame: Week 4
measure: Average changes from baseline in sitSBP
timeFrame: Week 4, 8
measure: Blood pressure responder rate
timeFrame: Week 4, 8
Other outcomes:
Locations:
city: Seoul, Busan, etc.
country: Korea, Republic of
facility: 14 sites in Korea
Study officials:
affiliation: Severance Hospital
name: Seung-Yun Cho, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Park CG, Youn HJ, Chae SC, Yang JY, Kim MH, Hong TJ, Kim CH, Kim JJ, Hong BK, Jeong JW, Park SH, Kwan J, Choi YJ, Cho SY. Evaluation of the dose-response relationship of amlodipine and losartan combination in patients with essential hypertension: an 8-week, randomized, double-blind, factorial, phase II, multicenter study. Am J Cardiovasc Drugs. 2012 Feb 1;12(1):35-47. doi: 10.2165/11597170-000000000-00000.
Clinical trial NCT04777344: Clinical Effort Against Smoke Exposure in Cystic Fibrosis
Official title: Clinical Effort Against Smoke Exposure in Cystic Fibrosis (CEASE-CF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: caregivers
tobacco
smoke exposure
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Cystic Fibrosis Foundation
First posted: 2021-03-02
Enrollment: 36
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single-center, randomized, open-label study
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The study will test the feasibility, acceptability, and preliminary efficacy of a multi-component smoking cessation intervention tailored to the needs of caregivers of children with CF and delivered in clinical settings as part of routine CF care. The ultimate goal of this effort is to reduce the exposure of children and adolescents with CF to tobacco smoke.

Detailed description: This is a single-center, randomized, open-label study to test the feasibility and acceptability (primary outcomes) and preliminary efficacy (secondary outcome) of a multi-component smoking-cessation intervention delivered by a tobacco treatment specialist (TTS) integrated in the multidisciplinary CF care team.

The intervention will be tested in a two-group design with a 2:1 allocation. Participants (dyads of caregiver/CF child) will be randomized to either intervention or control group. The intervention group (N=24) will receive the multi-component intervention (intake assessment, follow-up, help with obtaining nicotine replacement therapy, and CF-specific smoke exposure education). The control group (N=12) will receive usual care plus CF-specific smoke exposure education.

Eligibility criteria: Inclusion Criteria:

* Adult familial caregiver of a child with CF aged \<18 years
* Speak English
* Report smoking at least 1 cigarette in the previous week
* Not enrolled in a smoking cessation program

Exclusion Criteria:

* Do not report smoking at least 1 cigarette in the previous week
* Currently enrolled in a smoking cessation program.

Primary outcomes:
measure: Intervention feasibility
timeFrame: 6 months
measure: Intervention acceptability
timeFrame: 6 months
Secondary outcomes:
measure: Self-reported caregiver cessation
timeFrame: 6 months
measure: Child smoke exposure
timeFrame: 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
References:
Clinical trial NCT03219944: Clinical Evaluation of Platelet Rich Fibrin Versus Subepithelial Connective Tissue Graft for Soft Tissue Augmentation
Official title: Clinical Evaluation of Platelet Rich Fibrin Versus Subepithelial Connective Tissue Graft for Soft Tissue Augmentation Around Implant in the Aesthetic Zone: A Randomized Control Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patients With at Least Single Missing Anterior Tooth
Thin Gingival Biotype
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-07-18
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Soft tissue biotype is a critical factor for success of implant in the esthetic zone . Different soft tissue augmentation techniques have been employed to increase soft tissue thickness such as: autogenous grafts, allografts, xenografts and living cellular construct (LCC). Studies showed that, allografts and xenografts were inferior when compared with autogenous graft . However, few studies were conducted to evaluate the efficacy of soft tissue augmentation with platelet rich fibrin in order to overcome the patient morbidity with SCTG.


Eligibility criteria: Inclusion Criteria:

1. Patients with missing maxillary anterior toot teeth.
2. Thin gingival biotype.
3. Adequate inter-arch space for placement of the implant prosthetic part.
4. Good oral hygiene where gingival index is (0, 1) (Loe and Silness 1963).

Exclusion Criteria:

1. Patient with medical condition that is contraindicated with the surgical procedure
2. Patients receiving treatment that affect the healing ability.
3. Patients with local pathological defects related to the area of interest.
4. Smokers or pregnant women.
5. Patients with parafunctional habits that may jeopardize the implant longevity and affect the results of the study.

Primary outcomes:
measure: Crestal bone resorption
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Maymohamedkamal
state: Elmaniel
Study officials:
References:
Clinical trial NCT05758844: The Safe-line Technique as Additional Attempt to Mitigate Spinal Cord Ischemia After Endovascular Exclusion of TAAA
Official title: The Safe-line Technique as Additional Attempt to Mitigate Spinal Cord Ischemia After Endovascular Thoraco-abdominal Aneurysm Repair
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thoracoabdominal Aortic Aneurysm
Lead sponsor: University Hospital Padova
Sponsor class: OTHER
First posted: 2023-03-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inclusion of all patients treated for thoraco abdominal aortic aneurysm with endovascular repair and use of safe line technique

Brief summary: To assess safety and feasebility of the "safe-line" technique in a multicenter international collaboration.

Detailed description: To assess safety and efficacy of a technique for temporary aneurysm sac re-perfusion (TASreP) after total endovascular exclusion of TAAA, using a guide-wire left into the aneurysm sac. The technique can be applied both in elective that urgent cases.

The guide-wire aim to be a "safe-line" for fast temporary trans-sealing aneurysm sac re-perfusion in case of SCI occurring in the early post-operative period (48-to 72h).

Before completing exclusion, from the percutaneous femoral access, a second buddy-wire (V-18 guidewire; Boston Scientific) is advanced and left posterior to the endograft into the aneurysmal sac; through the main guide-wire, the final aneurysm exclusion is completed with distal stent-graft deployment and the femoral access sealed with Proglide leaving in place the sole V.018 draped in a sterile fashion. In the case of SCI occurrence in the post-operative period up to 48-72 hrs, the trans-sealing V.18 "safe-line" can be rapidly exchanged with a 6F/65 cm long Destination cm guiding sheath (Terumo) and positioned into the aneurysmal sac; this can be connected to a 6F introducer from the contralateral femoral artery and the sac perfused in a retrograde fashion.

Eligibility criteria: Inclusion Criteria:

* Thoraco-abdominal aortic aneurysm including type I,II,III,IV and V.
* Pararenale aneurysm
* Thoracoabdominal aortic aneurysm Elective and Urgent, endovascular repair;
* Endovascular repair of any thoracoabdominal aortic condition

Exclusion Criteria:

-thoraco-abdominal aortic aneurysm open repair

Primary outcomes:
measure: Incidence of adverse events
timeFrame: 7 days
measure: Incidence of spinal cord ischemia improvement or resolution
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Vascular and Endovascular Clinic - Padova University
Study officials:
References:
Clinical trial NCT05610644: Impact of Time Restricted Feeding on Daily Protein Requirements
Official title: Impact of Time Restricted Feeding on Daily Protein Requirements
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutrition Disorders in Old Age
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2022-11-09
Enrollment: 61
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The investigators aim to assess 24-hour protein kinetics at two different levels of protein intake: 0.8 (RDA) and 1.6g/kg/day (2RDA) during a normal dietary (TRAD) and a time restricted feeding (TRF) pattern in older adults.

Detailed description: The investigators aim to assess 24-hour protein kinetics at two different levels of protein intake: 0.8 (RDA) and 1.6g/kg/day (2RDA) during a normal dietary (TRAD) and a time restricted feeding (TRF) pattern in older adults. Individuals in the TRF pattern will only consume food during a 6-hour eating period and fast for the remaining 18 hours. Individuals in the TRAD pattern will consume isocaloric and isonitrogenous (RDA or 2RDA) diet but consume an all-beef-breakfast. Participants will consume oral stable isotopes to measure muscle protein synthesis (MPS), whole-body muscle protein breakdown (MPB), and whole-body protein balance (WBPB). Appropriate muscle, blood samples, and urine will be collected throughout a 24-hour metabolic trial following a 2-day controlled diet.

Eligibility criteria: Inclusion Criteria:

1. Men and women ages 50-75 years.
2. BMI 20-30 kg/m2 inclusive.
3. Capable of providing informed consent.
4. COVID-19 negative and/or asymptomatic

Exclusion Criteria:

1. Subject who does not/will not eat animal protein sources.
2. Body mass index \<20 or \>30.
3. Hemoglobin \<10g/dL at screening.
4. Platelets \<150,000/uL at screening.
5. History of diabetes.
6. History of chemotherapy or radiation therapy for cancer in the 6 months prior to enrollment.
7. History of gastrointestinal bypass/reduction surgery.
8. History of a chronic inflammatory disease (e.g. what?)
9. Currently receiving androgen (e.g., testosterone) or anabolic (e.g., GH, IGF-I) therapy.
10. Currently using prescription blood thinning medications.
11. Currently using corticosteroid medications.
12. Unable or unwilling to suspend aspirin use for 7 days prior to Visit 3.
13. Unwilling to avoid using protein or amino-acid supplements during participation.
14. Subjects who are unwilling to fast overnight.
15. Participating in \>200 minutes/week of vigorous exercise and/or \>4 days/week of resistance training.

Primary outcomes:
measure: Whole-body protein balance
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: UAMS (University of Arkansas for Medical Sciences)
name: David Church
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06536244: Impact of Perioperative Anesthetic Management on Renal Cancer Progression.
Official title: Impact of Perioperative Anesthetic Management on Renal Cancer Progression.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Perioperative Anesthetic
Renal Cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2024-08-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MD Anderson Cancer Center

Brief summary: The relationship between perioperative drugs, including preoperative medications, anesthetics, and analgesics, and postoperative outcomes in cancer patients is a complex and evolving field of study. Understanding how those medications might impact outcomes such as pain, acute kidney injury, and recurrence is crucial for optimizing perioperative care in renal cancer patients.

Detailed description: This retrospective study will investigate the association of perioperative drugs on short and long-term postoperative outcomes in patients undergoing kidney surgeries for renal cell carcinoma.

Eligibility criteria: Inclusion Criteria:

1. Adult Participants (18 years of age or older)
2. Participants having radical or partial nephrectomies with curative intent.

Exclusion Criteria:

1. Patients with distant metastatic disease and those with multiple (more than 1) primary tumors at the time of the nephrectomy
2. Biopsies
3. Participants who had radiofrequency or microwave ablations.

Primary outcomes:
measure: Postoperative complications
timeFrame: 72 hours and 30 days postoperatively
Secondary outcomes:
measure: Overall survival
timeFrame: Recurrence-free survival:The length of time from surgery to last seen without recurrence or with recurrent disease.
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Juan P Cata, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05160844: SIRT1 Gene Polymorphism With Premature Myocardial Infarction in Young Egyptian Patients
Official title: Association of SIRT1(rs7069102 ) Gene Polymorphism With Premature Myocardial Infarction in Young Egyptian Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premature Myocardial Infarction in Young Egyptian Patients
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-12-16
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: young egyptian patients under 40 years of age presented with recent MI admitted to CCU at sohag university hospital.

Brief summary: This is an observertional study aimed at Study the association of SIRT1(rs7069102 ) Gene polymorphism with premature myocardial infarction in young Egyptian patients


Eligibility criteria: Inclusion Criteria:

* All patient with recent MI admitted to Sohag University Hospital , CCU under 40 years

Exclusion Criteria:

* patients above 40 year old.
* Patients with malignancies, major trauma or surgery in the previous six months, and acute or chronic infectious disease

Primary outcomes:
measure: Endothelial nitric oxide synthase level
timeFrame: 6 months
measure: SIRT1 Genotyping
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag uniersity hosoital
Study officials:
affiliation: Sohag faculty of medicine
name: Amera Morad Foad hamdy, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00482144: Study of the Effects of the Pulsed-dye Laser at 585nm and 595nm to Treat Post-operative Scars on Suture-removal Day
Official title: Comparison of the Effectiveness of the Pulsed Dye Laser 585nm Versus 595nm in the Treatment of New Surgical Scars
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cicatrix
Scars
Keywords: Pulsed-Dye Laser
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2007-06-04
Enrollment: 20
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: The purpose of this study is to compare the effects of the pulsed-dye laser (PDL) at two different wavelengths, 585nm and 595nm, in the treatment of post-surgical scars starting on suture-removal day.

Detailed description: Many treatment modalities have been used for the treatment of scars such as dermabrasion, cryotherapy, intralesional corticosteroids, surgical scar revision, and lasers, among others. Previous studies have shown that treatment of scars with the pulsed dye laser (PDL) alone or in combination with other modalities (e.g. corticosteroids, 5-Fluoruracil, silicone sheets) improves the vascularity, pliability, color, and height of hypertrophic scars and keloids. Currently, the PDL has become the laser of choice for the treatment of scars.

To our knowledge, there are no reports in the literature comparing the effects of different wavelengths of the PDL for the treatment of scars. The objective of this study was to compare the effects of the PDL at 585nm vs 595nm in the treatment of postsurgical linear scars starting the day of suture removal.

Eligibility criteria: Inclusion Criteria:

* Age 18-65
* Postoperative linear scars greater than 6 cm
* Skin photo-types I-IV

Exclusion Criteria:

* Patient should not be taking any systemic, topical, or intralesional treatment of the scars

Primary outcomes:
measure: Vancouver Scar Scale Visual Analog Scale
timeFrame: 9 months
Secondary outcomes:
measure: Visual Analog Scale
timeFrame: 9 months
measure: Blinded Evaluator assessments
timeFrame: 9 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Sylvester Comprehensive Cancer Center
state: Florida
Study officials:
affiliation: University of Miami
name: Keyvan Nouri, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nouri K, Jimenez GP, Harrison-Balestra C, Elgart GW. 585-nm pulsed dye laser in the treatment of surgical scars starting on the suture removal day. Dermatol Surg. 2003 Jan;29(1):65-73; discussion 73. doi: 10.1046/j.1524-4725.2003.29014.x.