louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05077553: TCI999 in the Efficacy Verification Program of Hair and Body Health Care
Official title: Lactobacillus Plantarum TCI999 in the Efficacy Verification Program of Hair and Body Health Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hair Loss
Lead sponsor: TCI Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-10-14
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To assess TCI999 on hair and body health care


Eligibility criteria: Inclusion Criteria:

* Healthy adults aged above 20 years old

Exclusion Criteria:

* Subject who is not willing to participate in this study.
* Patients with diseases of the skin, liver, kidney.
* Subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder.
* Female who is pregnant or nursing or planning to become pregnant during the course of the study.
* The students taught by the PI.
* Subjects who have wounds on the scalp and subjects who have used drugs to treat the scalp, received hair transplants or other scalp treatments within six months

Primary outcomes:
measure: The change of hair loss amount
timeFrame: Change from Baseline hair loss amount at 12 weeks
measure: The change of hair density
timeFrame: Change from Baseline hair density at 12 weeks
measure: The change of hair follicle strength
timeFrame: Change from Baseline hair follicle strength at 12 weeks
measure: The change of intestinal microbiota
timeFrame: Change from Baseline intestinal microbiota at 12 weeks
Secondary outcomes:
measure: The change of scalp gloss
timeFrame: Change from Baseline scalp gloss at 12 weeks
measure: The change of scalp redness
timeFrame: Change from Baseline scalp redness at 12 weeks
measure: The change of scalp health
timeFrame: Change from Baseline scalp health at 12 weeks
measure: The change of hair diameter
timeFrame: Change from Baseline hair diameter at 12 weeks
measure: The change of dihydrotestosterone of blood
timeFrame: Change from Baseline hair diameter at 12 weeks
measure: The change of testosterone of blood
timeFrame: Change from Baseline testosterone at 12 weeks
measure: The change of SRD5A1 gene expression of blood
timeFrame: Change from Baseline SRD5A1 gene expression at 12 weeks
measure: The change of AR gene expression of blood
timeFrame: Change from Baseline AR gene expression at 12 weeks
measure: The change of TGF-β gene expression of blood
timeFrame: Change from Baseline TGF-β gene expression at 12 weeks
measure: The change of IGF-1 gene expression of blood
timeFrame: Change from Baseline IGF-1 gene expression at 12 weeks
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: Chia Nan University of Pharmacy ＆ Science
Study officials:
affiliation: Chia Nan University of Pharmacy ＆ Science
name: Chia-Hua Liang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05173753: Novel Self-Adhesive Composite Hybrid Versus Conventional Composite in Restoration of Carious Primary Teeth.
Official title: Novel Self-Adhesive Composite Hybrid Versus Conventional Composite in Restoration of Carious Primary Teeth. A Split Mouth Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries in Children
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-12-30
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: for both the intervention group and control group, the procedure and follow up will be done parallel to each other(same time).
Primary purpose: TREATMENT

Brief summary: The clinical trial aim to evaluate clinical effectiveness of self-adhesive composite hybrid (Surefil one) versus conventional composite(VOCO Grandio) as restorative material for carious primary teeth.

Detailed description: Composite resin is a continuous improving material as its full fill many requirements seeking in dental restorative materials, but is the new introducing composite resin material is always better than the previous one? This randomized clinical trial is performed to discus and assess that hypothesis. A total of 120 class I restoration(60 Surefil one novel self-adhesive composite hybrid \& 60 VOCO Grandio conventional composite resin) will be placed in posterior teeth of 60 volunteers(splint mouth design) following the manufacturer instruction. age between 4-7 years. The restorations will then be evaluate clinically at baseline, 3, and 6 month intervene. Both the procedure and follow up will done in the out-patient clinic, Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University, Cairo, Egypt.

Eligibility criteria: Inclusion criteria:

Children:

Good general health and medically free patients. Age ranges: from 4-7 years old. A provided informed consent by the parents. Acceptable child cooperation.

Teeth:

Class I carious primary teeth. 2 contralateral or adjacent carious teeth. Simple caries, extending to the dentin. No singe or symptom of pulp inflammation. Normal radiographic examination.

Exclusion Criteria:

Children:

Unable to attend follow-up visits. Refusal of participation.

Teeth:

Symptom tooth. Periapical Pathosis. Mobile primary tooth.

Primary outcomes:
measure: clinical effectiveness
timeFrame: 6 month intervene
Secondary outcomes:
measure: The cost effectiveness
timeFrame: 6 month intervene
measure: Duration of procedure
timeFrame: 6 month intervene
measure: Child cooperation
timeFrame: 6 month intervene
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Kamal Aldin El Motayam, Professor
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Passant Nagi, PHD
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Mahitab M Abdel khalek, BDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Fatema H Mohamed, BDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02780453: Prophylactic Negative Pressure Dressings for Closed Laparotomy Wounds - A Randomised, Controlled, Open Label Trial
Official title: Prophylactic Negative Pressure Dressings for Closed Laparotomy Wounds - A Randomised, Controlled, Open Label Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infection
Lead sponsor: University Hospital of Limerick
Sponsor class: OTHER
First posted: 2016-05-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Laparotomy wounds are associated with high rates of surgical site infections (SSI). The effect of prophylactic negative pressure dressing of closed incisional wounds on SSI rates is inconclusive.


Eligibility criteria: Inclusion Criteria:

* Elective and emergency abdominal surgery

Exclusion Criteria:

-

Primary outcomes:
measure: Surgical site infection rate
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Limerick
country: Ireland
facility: University Hospital Limerick
Study officials:
References:
citation: O'Leary DP, Peirce C, Anglim B, Burton M, Concannon E, Carter M, Hickey K, Coffey JC. Prophylactic Negative Pressure Dressing Use in Closed Laparotomy Wounds Following Abdominal Operations: A Randomized, Controlled, Open-label Trial: The P.I.C.O. Trial. Ann Surg. 2017 Jun;265(6):1082-1086. doi: 10.1097/SLA.0000000000002098.
Clinical trial NCT04106453: Navigated Laparoscopic Microwave Ablation of Tumor Mimics in Pig Liver - an Ex-vivo Trial
Official title: Navigated Laparoscopic Microwave Ablation of Tumor Mimics in Pig Liver - an Ex-vivo Single Center Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Cancer
Surgery
Navigation, Spatial
Keywords: laparoscopy
navigation
microwave ablation
ultrasound guidance
Lead sponsor: Universitätsklinikum Köln
Sponsor class: OTHER
First posted: 2019-09-27
Enrollment: 4
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: In primary and secondary liver tumors microwave ablation could be an alternative to surgical resection.It could be performed laparoscopically. Under ultrasound control the microwave device is placed in the tumor.Therefore spatial orientation is challenging: the tumor is often missed and the failure rate is high. During learning curve this could lead to incomplete tumor ablation and high rate of local recurrence. Targeting systems could optimize that. The CasOne-SPOT-system is an innovative electromagnetic tracking and navigation system for laparoscopic microwave ablation. In this study targeting precision using the SPOT-System should be compared to conventional laparoscopic ultrasound-guided microwave ablation. Therefore tumor mimics (1-2cm) will be created in ex-vivo pig livers and microwave ablation will be performed ultrasound guided or ultrasound navigated. The ablation procedures will be performed by two novices and two experienced surgeons. Aim of this trial is to is to evaluate, if laparoscopic microwave ablation could be facilitated by the use of the SPOT-navigation system.


Eligibility criteria: Inclusion Criteria:

board certified surgeon with experienced liver surgery with/ without experience in laparoscopic microwave ablation

Exclusion Criteria:

* non

Primary outcomes:
measure: time to complete ablation
timeFrame: 0-10 minutes
Secondary outcomes:
measure: ablation completeness
timeFrame: up to 1 day
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University of Cologne, Department of General, Visceral and Cancer Surgery
Study officials:
affiliation: General, Visceral, Cancer and Transplant Surgery, University of Cologne
name: Roger Wahba, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05126953: 2-Hour Dispensing Evaluation of Samfilcon A Lenses With EPG01 Packaging Solution Compared to Commercially Available B+L Ultra Lenses
Official title: 2-Hour Dispensing Evaluation of Samfilcon A Lenses With EPG01 Packaging Solution Compared to Commercially Available B+L Ultra Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contact Lens Wearer
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2021-11-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this 2 hour study is to evaluate the clinical performance of samfilcon A lenses with an alternate packaging solution (EPG01) compared to commercially available B+L Ultra lenses.


Eligibility criteria: Inclusion Criteria:

1. Be 18 years or older on the date the Informed Consent Form (ICF) is signed and have capacity to read, understand and provide written voluntary informed consent.
2. Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
3. Have no active ocular disease or allergic conjunctivitis.
4. Not be using any topical ocular medications.
5. Be willing and able to follow instructions.
6. Have signed a statement of informed consent.

Exclusion Criteria:

1. Participating in a conflicting study in the opinion of the Investigator.
2. Considered by the Investigator to not be a suitable candidate for participation.

Primary outcomes:
measure: Normalized logMAR Visual Acuity
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch and Lomb Site 01
state: New York
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Jeffery Schafer, OD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02146053: Questionnaire to Assess Gastrointestinal Symptoms of Oral Iron.
Official title: Validation of a Simple Questionnaire to Assess Gastrointestinal Symptoms After Oral Ferrous Sulphate Supplementation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Anemia
Constipation
Diarrhea
Abdominal Pain
Heartburn
Side Effect
Keywords: healthy participants
gastrointestinal side-effects associated with oral iron
Lead sponsor: Medical Research Council
Sponsor class: OTHER_GOV
Collaborators: name: King's College London
First posted: 2014-05-23
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: BASIC_SCIENCE

Brief summary: Oral iron supplementation is often associated with rapid onset of gastrointestinal side-effects. The aim of this study was to develop and trial a short, simple questionnaire to capture these early side-effects and to determine which symptoms are more discriminating.

The study was a double-blind placebo-controlled randomized parallel trial with one week treatment followed by one week wash-out. Subjects were randomized into two treatment groups (n=10/group) to receive either ferrous sulphate (200 mg capsules containing 65 mg of iron) or placebo, both to be taken at mealtimes twice daily during the treatment period. Subjects completed the questionnaires daily for 14 days. The questionnaire included gastrointestinal symptoms commonly reported to be associated with the oral intake of ferrous iron salts (i.e. nausea, vomiting, heartburn, abdominal pain, diarrhoea, and constipation).


Eligibility criteria: Inclusion Criteria:

* Generally healthy subjects.

Exclusion Criteria:

* The presence of any chronic disease, pregnancy or lactation were considered as exclusion criteria.

Primary outcomes:
measure: gastrointestinal symptoms
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College London
Study officials:
affiliation: King's College London
name: Miranda Lomer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: MRC Human Nutrition Research
name: Jonathan Powell, PhD
role: STUDY_CHAIR
References:
citation: Pereira DI, Couto Irving SS, Lomer MC, Powell JJ. A rapid, simple questionnaire to assess gastrointestinal symptoms after oral ferrous sulphate supplementation. BMC Gastroenterol. 2014 Jun 4;14:103. doi: 10.1186/1471-230X-14-103.
Clinical trial NCT03660553: Simplified Insulin Regimen for the Elderly
Official title: Effect of Simplified Insulin Regimen on Glycemic Control and Quality of Life in an Elderly Population With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes
Elderly
Insulin treatment
Quality of life
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2018-09-06
Enrollment: 7
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Basal-bolus insulin therapy, which includes one injection of long acting insulin and three injections of short acting insulin is the most commonly used insulin treatment. However, many older patients find the basal-bolus insulin regimen hard to manage because it involves 4 injections and 4 blood glucose tests each day. It is possible that a simplified treatment that involves one injection of long acting insulin daily and two blood glucose tests daily might be equally effective. This simplified regimen, if effective, would be easier to use and might result in less errors. Therefore, the investigators want to conduct this study to compare using a single daily injection of basal insulin with the usual basal-bolus insulin regimen in elderly patients (age \>65 years) with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

-Age \>65 years

Exclusion Criteria:

* Unable to provide informed consent
* Enrollment in another research study
* History of hypoglycemia unawareness
* Pregnant women
* Prisoners

Primary outcomes:
measure: Hemoglobin A1c (HbA1c)
timeFrame: 6 months
Secondary outcomes:
measure: Incidence of Any Hypoglycemia
timeFrame: 6 months
measure: Incidence of Severe Hypoglycemia
timeFrame: 6 months
Other outcomes:
Locations:
city: South Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Rajesh Garg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02693353: Epiretinal Membrane and Pseudophakic Cystoid Macular Edema
Official title: Association of Cystoid Macular Edema After Cataract Surgery in Patients With and Without Epiretinal Membrane
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Macular Edema
Epiretinal Membrane
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2016-02-26
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients over 18 who are undergoing cataract surgery at Loma Linda University Eye Institute

Brief summary: Prospective, observational cohort study evaluating the association between pre-surgical existence of an epiretinal membrane (ERM) and the development of pseudophakic cystoid macular edema (PCME) using spectral domain optical coherence tomography (OCT) measurements.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Cataract surgery patients

Exclusion Criteria:

* Pre-existing macular edema
* Choroidal neovascularization
* Uveitis
* Age-related macular degeneration
* Myopia \> 6 diopters
* Proliferative diabetic retinopathy
* Diabetics retinopathy great than mild in serverity

Primary outcomes:
measure: Cystoid Macular Edema diagnosed by OCT
timeFrame: Within 90 days post op
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
Study officials:
affiliation: Loma Linda University Medical Center
name: David Sierpina, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06095453: Evaluation of the Analgesic Efficacy of Multimodal Pain Control Regimens That Aim to Limit the Use of Narcotics in Cholecystectomy and Hernia Repairs
Official title: Evaluation of the Analgesic Efficacy of Multimodal Pain Control Regimens That Aim to Limit the Use of Narcotics in Cholecystectomy and Hernia Repairs
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Acute Pain
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects were patients of the five surgeons with Surgical Associates of Mansfield (SAM) who underwent an elective or urgent laparoscopic cholecystectomy; or elective or urgent laparoscopic or open hernia repair (inguinal, ventral, or umbilical); and who otherwise met the inclusion criteria. Incisional hernias were excluded. Emergent hernia operations that required bowel or colon resections due to strangulation were excluded

Brief summary: Subjects were patients of the five surgeons with Surgical Associates of Mansfield (SAM) who underwent an elective or urgent laparoscopic cholecystectomy; or elective or urgent laparoscopic or open hernia repair (inguinal, ventral, or umbilical); and who otherwise met the inclusion criteria. I

Detailed description: This performance improvement study is a retrospective review of data obtained from patients at Methodist Mansfield Medical Center (MMMC) in Mansfield, Texas from May 1, 2022 to September 30, 2022. Subjects were patients of the five surgeons with Surgical Associates of Mansfield (SAM) who underwent an elective or urgent laparoscopic cholecystectomy; or elective or urgent laparoscopic or open hernia repair (inguinal, ventral, or umbilical); and who otherwise met the inclusion criteria. Incisional hernias were excluded. Emergent hernia operations that required bowel or colon resections due to strangulation were excluded

Eligibility criteria: Inclusion Criteria:

Patients of the five physicians of the SAM group Patients ≥18 years Patients undergoing urgent or elective laparoscopic and robotic cholecystectomy OR patients undergoing urgent or elective laparoscopic, robotic or open hernia repair (ventral, umbilical, or inguinal).

Exclusion Criteria:

Patients \<18 years Patients with chronic pain conditions managed with chronic use of narcotics Patients that underwent incisional hernia repairs Patients that underwent complicated hernia repairs that included other operations such as colon and bowel resection procedures

Primary outcomes:
measure: Narcotics Doses and timeframe
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: Mansfield
name: Joshua Trussell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03478553: The Genetics of Pulmonary Fibrosis
Official title: Idiopathic Pulmonary Fibrosis, a Disease Initiated by Mucociliary Dysfunction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Idiopathic Pulmonary Fibrosis (IPF)
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2018-03-27
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will include up to 20,000 people in the country, both people with IPF and their family members who have never been diagnosed with IPF.

Brief summary: This study seeks to screen first degree family members of people with Idiopathic Pulmonary Fibrosis (IPF) for the earliest signs of lung fibrosis.

Detailed description: The purpose of this study is to explore genetic factors associated with the development of pulmonary fibrosis. The investigators aim is to identify and explore genetic loci that affect development of pulmonary fibrosis and also explore related environmental exposures. Idiopathic pulmonary fibrosis (IPF) is one of the interstitial lung diseases under the broader umbrella of idiopathic interstitial pneumonias (IIP). The investigators hypothesize that inherited genetic factors are associated with pulmonary fibrosis. To investigate the genetics of pulmonary fibrosis, the investigators plan to enroll individuals with pulmonary fibrosis and their family members.

Eligibility criteria: Inclusion Criteria:

* Age at least 18 years old
* Family member diagnosed with IPF

Exclusion Criteria:

- No family member with IPF

Primary outcomes:
measure: Identify and explore genetic loci and related environmental exposures in individuals with familial pulmonary fibrosis and their relatives.
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: David A Schwartz, MD
role: PRINCIPAL_INVESTIGATOR
References: