louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01083927: Rotational Narrow Strip Versus Full Conjunctival Graft in Pterygium Excision
Official title: Rotational Narrow Strip Versus Full Conjunctival Graft in Pterygium Excision
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pterygium
Keywords: Pterygium
Lead sponsor: University of Malaya
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Malaysia
First posted: 2010-03-10
Enrollment: 94
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the efficacy of rotational narrow strip conjunctival graft to full conjunctival graft in primary pterygium excision. Risk analysis of factors that may affects the recurrence rate.

Detailed description: Pterygium is a raised, wing-shaped growth of fibrovascular tissue that extends horizontally from the bulbar conjunctiva, crossing the limbus, and onto the cornea. It is a common ocular surface disease in Malaysia.

Pterygium can cause chronic ocular irritation, redness, tearing, visual impairment and poor cosmesis. Treatment of symptomatic pterygium remains surgical. Surgery should achieve low recurrence rate and acceptable cosmesis. Various surgical techniques had been described with variable success.

In this study, we compared the efficacy of Rotational Narrow Strip Conjunctival Graft with the conventional full conjunctival graft in pterygium excision. Patient will be follow up for a year after pterygium surgery. Outcome will be recurrence rate between the two groups at one year. Risk analysis of certain factors that affects the recurrence rate will be discussed.

Eligibility criteria: Inclusion Criteria:

1. Significant and symptomatic primary pterygium clinically requiring excision
2. Willingness to participate in research project and to attend research time

Exclusion Criteria:

1. Age \< 21 years
2. Glaucoma in the study eye
3. Other concurrent ocular surface pathology
4. Infection of the ocular surface
5. Poor general health

Primary outcomes:
measure: Recurrence Rate of Pterygium operated with Rotational Narrow Strip Conjunctival Graft and Full Conjunctival Graft Excision
timeFrame: 1 year
Secondary outcomes:
measure: Analysis of risk factors associated with recurrence of pterygium
timeFrame: 1 year
Other outcomes:
Locations:
city: Kuching
country: Malaysia
facility: Sarawak General Hospital
state: Sarawak
Study officials:
affiliation: University Malaya Eye Research Centre
name: Lo Sheau Kang, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06853860: Effects of Hand Massage Applied With Two Different Methods
Official title: Effects of Hand Massage Applied With Two Different Methods on Pain, Anxiety and Physiological Parameters in Patients After Coronary Angiography: A Double-Blind Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Angiopathy, Peripheral
Pain, Acute
Reflexology
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2025-03-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a double-blind randomized controlled trial planned to investigate the effects of hand massage applied with two different methods on pain, anxiety and physiological parameters in patients undergoing coronary angiography.
Primary purpose: SUPPORTIVE_CARE

Brief summary: There is no study finding examining the effects of the classical hand massage and hand reflexology massage methods on pain, anxiety and physiological parameters after coronary angiography. Therefore, the aim of this study is to examine the effects of reflexology hand massage and classical hand massage on pain, anxiety and physiological parameters after coronary angiography.

Detailed description: There is no study finding examining the effects of the classical hand massage and hand reflexology massage methods on pain, anxiety and physiological parameters after coronary angiography.

Eligibility criteria: Inclusion Criteria:

* • Patients who are over 18 years old

  * Can speak Turkish
  * Agree to participate in the study
  * Have not undergone emergency coronary angiography
  * Have not consumed coffee or hypnotic drugs at least 12 hours before
  * Have no history of chronic pain (e.g. arthritis)
  * Are not addicted to alcohol or drugs
  * Have no psychological problems (such as depression, anxiety disorder)
  * Have no problem with having their hands massaged; those who do not have any skin lesions, sensory and motor disorders, amputations, burns, or pathological diseases related to muscles and bones
  * Have not used anxiolytics

Exclusion Criteria:

* • Those who do not volunteer to participate in the study

  * Those who have any skin lesions, burns, open wounds, muscle and bone pathological diseases on their hands,
  * Those who develop delirium during the follow-up period
  * Those who develop complications after coronary angiography (such as bleeding, etc.)
  * Arrhythmia
  * Hemodynamic instability

Primary outcomes:
measure: average pain score
timeFrame: 0 hour, 1st hour, 2nd hour, 3th hour
measure: State Anxiety Scale mean score
timeFrame: 0 hour, 1st hour, 2nd hour, 3th hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06006260: Changes of Low Anterior Resection Syndrome and Balance Ability in Patients with Rectal Cancer.
Official title: Changes of Low Anterior Resection Syndrome, Balance Ability, and Quality of Life in Patients with Newly Diagnosed Rectal Cancer.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rectal Cancer
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2023-08-23
Enrollment: 110
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Rectal cancer patients during therapy.

Brief summary: The purposes of this study are to explore the trajectory of symptom distress and balance ability in patients with rectal cancer.


Eligibility criteria: Inclusion Criteria:

1. Newly diagnosed rectal cancer
2. Patients already know their condition.
3. Aged 20 years and older.
4. Consciously communicate in Mandarin or Taiwanese.
5. Agreed with the interview and had signed the permit.

Exclusion Criteria:

1. Recurrent rectal cancer.
2. KPS of patients less than 80

Primary outcomes:
measure: Self-report Questionnaire
timeFrame: Change from baseline symptom at 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan City
country: Taiwan
facility: Chung Gung University
state: Kwei-Shan Dist.
Study officials:
References:
Clinical trial NCT02708160: Assessment of Prevident Sodium Fluoride 1.1% Toothpaste Using an Intra-oral Remineralization-demineralization Model
Official title: Assessment of Prevident Sodium Fluoride 1.1% Toothpaste Using an Intra-oral Remineralization-demineralization Model
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Dental Caries
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2016-03-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a double blind, cross-over, controlled clinical trial utilizing thirty (30) adults to evaluate remineralization of early caries lesions.


Eligibility criteria: Inclusion Criteria:

1. Male and/or female subjects 18 to 50 years inclusive
2. Minimum of 20 natural uncrowned teeth (excluding third molars) must be present
3. Willing to wear retainer 24 hours per day
4. No active, unrestored cavities
5. Have normal salivary flow rate (stimulated and unstimulated flow of ≥0.7 ml/min and ≥ 0.2 ml/min respectively) ascertained from a preliminary sialometry
6. Available throughout entire study
7. Willing to use only assigned products for oral hygiene throughout the duration of the study
8. Must give written informed consent
9. Must be in good general health
10. No known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study

Exclusion Criteria:

1. Advanced periodontal disease
2. Medical condition which requires premedication prior to dental visits/procedures
3. Not enough teeth to secure the oral retainer
4. Diseases of the soft or hard oral tissues
5. Wear an Orthodontic retainer(s)
6. Impaired salivary function
7. Current use drugs that can affect salivary flow
8. Use antibiotics one (1) month prior to or during this study
9. Positive urine test for pregnancy (a urine pregnancy test will be performed on female subjects of child-bearing potential)
10. Participate in another clinical study one (1) week prior to the start of the washout period or during this 9-week study period
11. Use tobacco products
12. Allergic history to common toothpaste ingredients
13. Immune compromised individuals (HIV, AIDS, immuno-suppressive drug therapy) as determined by review of medical history

Primary outcomes:
measure: Mineral Change (delta Z)
timeFrame: Baseline
measure: Mineral Change (delta Z)
timeFrame: 2 weeks (from Baseline)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Texas
name: Bennet Amaechi, PhD, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00609960: Clowns as Treatment for Preoperative Anxiety in Children: A Randomized Controlled Trial
Official title: Clowns as Treatment for Preoperative Anxietyin Children- a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre Operative Anxiety
Keywords: children anesthesia anxiety clowns
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2008-02-07
Enrollment: 65
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study wants to test the hypothesis that trained clowns can reduce anxiety in children undergoing general anesthesia. We will compare the effect of the clowns to the commonly used anti-anxiety medication we commonly use

Detailed description: The perioperative environment, often anxiety-provoking for adults, may be quite frightening for children. The detrimental effects of preoperative anxiety are not confined to the preoperative period. Anxiety during induction of anesthesia is correlated with increased distress early in the postoperative period, (Holms Knud, Kain) and maladaptive behavior will follow for the first 2 weeks following surgery in up to 54% of children.

Many preoperative systems allow parental, pharmacologic, and anticipatory interventions to facilitate a relaxed perioperative environment for children. Unfortunately, scheduling conflicts, side effects, and limited resources conspire to limit their usefulness. For example, only 10% of respondents in a recent survey used parental presence during induction of anesthesia (PPIA) for a majority of their patients. This may be due to the belief by some that parental anxiety may in fact increase children's anxiety. (Bevans) According to the same survey, only 50% of children undergoing surgery receive sedating premedication. (Kain). Distraction techniques, such as the use of toys or video games, may also decrease perioperative anxiety, however their effectiveness during induction of anesthesia is not well characterized. The efficacy of toys and video games is somewhat dependent upon the child reaching certain developmental milestones. Anesthesiologists continue to search for an easy and comprehensive method for anxiety reduction in the pediatric surgical population. We propose that specially trained professional clowns may allay preoperative anxiety and result in a smooth anesthetic induction.

Eligibility criteria: Inclusion Criteria:

* ASA I and II
* Children aged 2-8 years

Exclusion Criteria:

* Previous surgery
* ASA \> II
* Parents' refusal

Primary outcomes:
measure: anxiety level
timeFrame: waiting area and enterance to OR -1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
state: Ramat Gan
Study officials:
affiliation: Sheba Medical Center
name: Ilan Keidan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03498560: Examining the Association Between Pre-existing Sleep Disturbance and Postoperative Delirium
Official title: Examining the Association Between Pre-existing Sleep Disturbance and Postoperative Delirium
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2018-04-13
Enrollment: 38
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatients over the age of 60 scheduled for a surgical procedure at MGH

Brief summary: The investigators are performing this research study to understand the role of sleep disturbance on the incidence/severity of delirium after surgery. The investigators will study the brain using a polysomnography device (PSG), which records the brain's electrical activity during sleep.

Detailed description: During this study, PSG recordings will be collected and a sleep questionnaire will be administered to participants on the night before surgery in order to establish level of preexisting sleep disturbance. Delirium assessments will be conducted during the postoperative period. On postoperative days 0 and 1, blood will be collected for analysis. Further cognitive, quality of life and pain questionnaires will be administered perioperatively.

Eligibility criteria: Inclusion Criteria:

* Over 60 years of age
* Inpatient and scheduled for surgical procedure at MGH

Exclusion Criteria:

* Blindness, deafness or the inability to speak English
* Inability to provide informed consent

Objective Drop Criteria

* Post-operative intubation greater than 24 hours

Primary outcomes:
measure: Association Between Sleep and POD
timeFrame: Night before surgery, approximately 13 hours
Secondary outcomes:
measure: Burst Suppression Ratio
timeFrame: Length of surgery (2-12 hours)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
citation: Ibala R, Mekonnen J, Gitlin J, Hahm EY, Ethridge BR, Colon KM, Marota S, Ortega C, Pedemonte JC, Cobanaj M, Chamadia S, Qu J, Gao L, Barbieri R, Akeju O. A polysomnography study examining the association between sleep and postoperative delirium in older hospitalized cardiac surgical patients. J Sleep Res. 2021 Oct;30(5):e13322. doi: 10.1111/jsr.13322. Epub 2021 Mar 24.
Clinical trial NCT02796560: Generic Travoprost Versus Brand Name Travoprost in Patients With Primary Open Angle Glaucoma or Ocular Hypertension
Official title: Randomized Crossover Trial Comparing the Hypotensive Effect of Generic Travoprost With That of the Brand Name Travoprost in Patients With Primary Open Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma, Primary Open Angle
Ocular Hypertension
Keywords: Drugs, Generic
Generic Equivalency
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2016-06-10
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy and tolerance of generic travoprost with its brand name formulation. In this open label, randomized, crossover study, the primary outcome will be intraocular pressure and the secondary outcome will be tolerance to the drops, as measured by a subjective questionnaire. Patients will be randomized to receive either brand name or generic travoprost during the first visit. At the second visit 3 weeks later, their intraocular pressure will be measured and a questionnaire will be completed on the tolerance of the medication. Patients will then receive the other formulation of travoprost. At the third and final visit, another 3 weeks later, their intraocular pressure will be measured and a questionnaire will be completed on the tolerance of the second medication.


Eligibility criteria: Inclusion Criteria:

* Be apt to give consent
* Have a diagnostic of primary open angle glaucoma or ocular hypertension requiring treatment

Exclusion Criteria:

* Angle closure glaucoma or having benefited from a peripheral iridotomy
* Known allergies to travoprost or to one of the ingredients
* Current usage of other glaucoma drops other than travoprost
* Current usage of topical corticosteroids
* Pregnancy
* Breast feeding
* Monophthalmic
* Having benefited from glaucoma surgery including trabeculectomies, implant drainage devices, and selective laser trabeculectomies
* Active intraocular inflammation
* Ocular surface disease that interferes with accurate measuring of the intraocular pressure
* Any clinically significant ocular disease that could interfere with the study

Primary outcomes:
measure: Intraocular Pressure
timeFrame: After 3 weeks of either the brand name or generic travoprost
Secondary outcomes:
measure: Comfort and Intolerance to the Drops Questionnaire
timeFrame: After 3 weeks of either the brand name or generic travoprost
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Hotel-Dieu de Sherbrooke (CHUS)
state: Quebec
Study officials:
affiliation: Université de Sherbrooke, Hôtel Dieu de Sherbrooke
name: Marjorie Carbonneau, MD, FRCS(C)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06489860: SARS-CoV-2 Safety Study for the Treatment of COVID-19
Official title: SARS-CoV-2 Safety Study for the Treatment of COVID-19
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: SARS-CoV-2
Lead sponsor: DHA Coffee Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-07-08
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 130
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: SARS-CoV-2. Directions: For adults and for Children 1-12 years old. Indication: SARS-CoV-2.

Ingredient: Organic Rice 95% and Honey 5% Powder (whole) 1g.
Primary purpose: TREATMENT

Brief summary: SARS-CoV-2 produced strong pluripotent stem cells and brain cells to protect Telomere chromosomes to maintain Acid Deoxyribonucleic (ADN) Molecules.

Detailed description: SARS-CoV-2 produced strong pluripotent stem cells and brain cells to change and disappear defective cells in virus variants, Covid-19 disease. Pluripotent stem cells produced strong cells serve as a repair system, replacing damaged cells, defective cells and dead cells.

CHEMISTRY:

SARS-CoV-2 does not use any chemicals, no colors and no additives and no preservatives.

Toxicology:

SARS-CoV-2 product is not adverse effect, non-toxic and no pharmacal toxicology.

SARS-CoV-2 is not placebo drug

Eligibility criteria: Inclusion Criteria:

* SARS-CoV-2

Exclusion Criteria:

Primary outcomes:
measure: SARS-CoV-2
timeFrame: From September to October, 2024
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: DHA Coffee Co., Ltd
name: PHUOC T DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zarin DA, Tse T, Williams RJ, Califf RM, Ide NC. The ClinicalTrials.gov results database--update and key issues. N Engl J Med. 2011 Mar 3;364(9):852-60. doi: 10.1056/NEJMsa1012065.
Clinical trial NCT04564560: Graft Thrombosis After Endovascular Aortic Repair - a Single Center Experience With the Cook Zenith Alpha Spiral-Z®
Official title: Graft Thrombosis After Endovascular Aortic Repair - a Single Center Experience With the Cook Zenith Alpha Spiral-Z®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aorta Aneurysm
Keywords: Stents
Thrombosis
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
First posted: 2020-09-25
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patient treated at St. Olavs Hospital in the period January 2017 until December 2019 with endovascular aortic repair using the Zenith Alpha Spiral-Z® .

Brief summary: The purpose of this study is to assess the extent of thrombosis in the Zenith Alpha Spiral-Z® stent graft.

Detailed description: Cook Medical has reported thrombus formation with or without occlusion of the Zenith Alpha Spiral-Z®. The purpose of this study is to measure the extent of thrombus formation and occlusion of these stent graft limbs in patients with aortic aneurysms treated at St. Olavs Hospital in 2017, 2018 and 2019. Information is collected from the Norwegian registry for vascular surgery (NORKAR), electronic patient journal and the picture archiving and communication system (PACS). The total number of included patients is estimated to be approximately 100.

Eligibility criteria: Inclusion Criteria:

* Patients that have received endovascular treatment with the Zenith Alpha Spiral-Z® for an aortic aneurysm
* The endovascular procedure was performed at St Olavs Hospital from January 2017 until December 2019

Exclusion Criteria:

* None

Primary outcomes:
measure: Percentage of patients who have got treated post-surgery due to thrombosis or occlusion of stent graft leg
timeFrame: 12-36 months
measure: Percentage of patients who got an amputation post-surgery due to thrombosis or occlusion of stent graft leg
timeFrame: 12-36 months
measure: Percentage of patients who died post-surgery
timeFrame: 12-36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital, Clinic of Surgery, Clinic of Radiology and Nuclear Medicine
Study officials:
affiliation: St Olavs Hospital, Dept Radiology and Nuclear Medicine
name: Morten Troøyen, md
role: STUDY_DIRECTOR
affiliation: St Olavs Hospital, Dept Surgery
name: Birger H Endreseth, md
role: STUDY_DIRECTOR
References: