louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05680857: Efficacy and Safety of Products Containing Marine Collagen Peptide and Coenzyme Q10 for Skin Rejuvenation
Official title: The Efficacy and Safety of Products Containing Marine Collagen Peptide and Coenzyme Q10 for Skin Rejuvenation in Malaysian Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre
Sponsor class: INDUSTRY
First posted: 2023-01-11
Enrollment: 32
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a placebo-controlled study conducted to investigates the safety and efficacy of products containing marine collagen peptide and CoQ10 in enhancing skin rejuvenation of Malaysian women. The study duration is 28 days and the skin assessment will be carried out at baseline, Day 14 and Day 28.The main questions it aims to answer are:

1. The effect of product on skin hydration of women in Malaysia.
2. The effect of product on skin elasticity of women in Malaysia.
3. The effect of product on skin wrinkle of women in Malaysia.
4. The skin brightening effect of product on Malaysian women.
5. To observe any adverse effect occurrence with the consumption of the product.


Eligibility criteria: Inclusion Criteria:

* Malaysian citizen
* Women aged 35 - 45 years old
* Willing to participate

Exclusion Criteria:

* Women with skin diseases or any underlying diseases.
* Pregnant, breastfeeding women or planned pregnancy during the study period
* Allergy to collagen or other ingredients that may be found in the product.
* Women who had any cosmetic procedures such as botox, laser and light treatment, facial surgery, and any procedures that may improve skin hydration, elasticity, wrinkles, and brightening of skin four weeks before the study.
* Women who took any dietary supplements, functional foods, or medicines that could have the same or similar effects as the product evaluated in this study in the past three months.

Primary outcomes:
measure: Changes in skin hydration from baseline and at Day 14 and Day 28 after consumption of a product.
timeFrame: Baseline, Day 14 and Day 28
measure: Changes in skin elasticity from baseline and at Day 14 and Day 28 after consumption of a product.
timeFrame: Baseline, Day 14 and Day 28
measure: Changes in skin wrinkles from baseline and at Day 14 and Day 28 after consumption of a product.
timeFrame: Baseline, Day 14 and Day 28
measure: Changes in skin tone from baseline and at Day 14 and Day 28 after consumption of a product.
timeFrame: Baseline, Day 14 and Day 28
measure: Adverse effect after consumption of product containing marine collagen peptide and coenzyme Q10.
timeFrame: 28 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Petaling Jaya
country: Malaysia
facility: Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre
state: Selangor
Study officials:
References:
Clinical trial NCT02062957: Endovascular Function in Atrial Fibrillation (AF) Patients
Official title: Endovascular Function in Patients With Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: PAT Result
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2014-02-14
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with AF

Brief summary: 1. recruit 50 patients with atrial fibrillation and 30 controls
2. endovascular function assessment with Peripheral Arterial Tonometry (PAT)
3. follow up the occurence of AF


Eligibility criteria: Inclusion Criteria:

* ≥2 paroxysmal (electrocardiographic documentation of at least 1) AF episodes lasting ≥1 hour in duration: (that terminate spontaneously within 7 days or cardioversion is performed within 48h of AF onset): or
* electrocardiographic documentation of 1 persistent AF episode: (sustained for ≥7 days or cardioversion is performed more than 48h after AF onset): or
* electrocardiographic documentation of 1 longstanding persistent AF episode: (continuous AF of duration \>1 year).

Exclusion Criteria:

* patients with cerebralvascular disease
* patients with coronary disease
* patients with peripheric artery disease

Primary outcomes:
measure: endovascular function results
timeFrame: Up to 24 weeks.
Secondary outcomes:
measure: predictive effect of endovascular function on recurrence of AF
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chaoyang Hospital
Study officials:
References:
Clinical trial NCT03821857: Sex-Specific Effects of Endocrine Disruption on Aging and Alzheimer's Disease
Official title: Sex-Specific Effects of Endocrine Disruption on Aging and Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Alzheimer Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2019-01-30
Enrollment: 200
Sex: FEMALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The researchers are trying to determine whether ovarian hormones are associated with aging processes and with the risk of developing Alzheimer's disease in women.

Detailed description: The proposed project will enroll 200 women. Each women will have one clinic visit consisting of cognitive testing, tests of physical function, questionnaires, and a blood draw. All women will also undergo clinical neuroimaging, which includes structural MRI, β-amyloid (Aβ) deposition on PET as a biomarker of Aβ pathology, and tau deposition on PET as a marker of neurofibrillary tangles using AV-1451.

Eligibility criteria: Inclusion Criteria:

* Women who lived in Olmsted County, Minnesota between 1988 and 2007
* Currently aged 55 years and older
* More than six months post chemotherapy or major surgery requiring general anesthesia
* Willing and able to sign informed consent

Exclusion Criteria:

* Not able to read and speak English
* In hospice
* Claustrophobic
* If undergoing Tau imaging, cannot have QT Prolongation

Primary outcomes:
measure: 18F-Flortaucipir PET imaging
timeFrame: 1 day
measure: Pittsburgh compound-B PET imaging
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Kejal Kantarci, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06406257: Temperature Management on Postoperative Delirium
Official title: Effect of Intraoperative Temperature Management on Postoperative Delirium in Elderly Patients Undergoing Hip Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Emergence Delirium
Keywords: Postoperative Delirium
Body Temperature
Hyperthermia
Hypothermia
Lead sponsor: Second People's Hospital of Hefei City
Sponsor class: OTHER
Collaborators: name: The Second Hospital of Anhui Medical University
First posted: 2024-05-09
Enrollment: 150
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Enrolled participants were randomly assigned to a control group (Group C) or a body temperature protection group (Group W) in a 1:1 ratio.
Primary purpose: PREVENTION

Brief summary: Presently, the effects of perioperative temperature management on postoperative delirium remain ambiguous. This study endeavors to explore the influence of intraoperative temperature variations in elderly hip fracture patients on postoperative delirium.

Detailed description: At present, the pathophysiological mechanisms contributing to postoperative delirium in elderly hip fracture patients remain elusive, with predominant research concentrating on neural inflammation, neurotransmitter dysregulation, and metabolic irregularities. The influence of perioperative temperature management on postoperative delirium remains uncertain and may correlate with surgical modality and intraoperative temperature modulation. Hence, this study endeavors to juxtapose intraoperative temperature variations among elderly hip fracture patients, probing their ramifications on postoperative delirium.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 65 years
* Classified as American Society of Anesthesiologists I-III
* Hip surgery patients who agreed to the study

Exclusion Criteria:

* Non-consent to participate
* Diagnosed neurological or psychiatric disorders including schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis
* Coma, dementia, or language impairment affecting communication and assessment
* History of neurosurgery
* Use of antipsychotic medication preoperatively
* Body temperature exceeding 38°C within 24 hours before surgery.

Primary outcomes:
measure: Incidence of postoperative delirium
timeFrame: Within 3 days after surgery
Secondary outcomes:
measure: Incidence of intraoperative hypothermia
timeFrame: During operation
measure: Pleiotropic cytokine in the patient's serum
timeFrame: Serum interleukin-6 (IL-6) levels before surgery and at 1, 2, and 3 days after surgery.
Other outcomes:
Locations:
Study officials:
affiliation: The Second Hospital of Anhui Medical University
name: Xianwen Hu, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02707757: Treatment Response in Dialysis Anaemia
Official title: Predictors of Response to Treatment With Iron and Erythropoietin in Dialysis Anaemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anaemia
Haemodialysis
Keywords: Haemodialysis
Anaemia
Iron
Erythropoeitin stimulating agents
Lead sponsor: Imperial College Healthcare NHS Trust
Sponsor class: OTHER
First posted: 2016-03-14
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Anaemia in dialysis patients requires treatment with frequent dose adjustments. There are two current possible treatments for anaemia which are iron and erythropoietin stimulating agents (ESA). Dosages of these medications are currently guided by a patient's ferritin levels and haemoglobin, but these markers are known to be inaccurate. The current clinical protocol therefore tends towards overuse of both agents which can be associated with toxicity, and the reliance on these markers prevents retrospective assessment of treatment responsiveness. This study is designed to investigate the factors which predict which agent would produce a better response. Patients with a fall in haemoglobin will be given treatment with either iron or an increased dose of ESA as they are currently, but allocated at random rather than by poorly performing biochemical markers. The iron treated and ESA treated groups can then be analysed for factors which predict response in o


Eligibility criteria: Inclusion Criteria:

* All prevalent haemodialysis patients of the Imperial Renal and Transplant Centre will be eligible for inclusion if they have been on dialysis for more than 3 months

Exclusion Criteria:

* Patients with a bone marrow disorder, active infection or active malignancy will be excluded as these are non-renal causes of anaemia. Patients unable to give informed consent will also not be included within the study.

Primary outcomes:
measure: Haemoglobin Increase of Greater or Equal to 5g/l Following Receipt of Treatment
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial Renal and Transplant Centre
city: London
country: United Kingdom
facility: Imperial NHS Healthcare Trust
Study officials:
affiliation: Imperial College Healthcare NHS Trust
name: Damien Dr Ashby, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00502957: Biofeedback Treatment for Functional Constipation
Official title: Biofeedback for Functional Constipation: Efficacy and Predictive Factors of Success
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation
Keywords: biofeedback
constipation
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2007-07-18
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this randomized, controlled trial is to examine how well biofeedback treatment works to improve constipation. The study is comparing two kinds of biofeedback treatment: 1) anorectal-specific biofeedback therapy and 2) generalized biofeedback therapy using relaxation techniques.

The study will also examine which medical and psychological factors determine biofeedback success for treating constipation, such as bowel habits, emotional reactions to constipation, and levels of stress and psychological distress.

Detailed description: This is a randomized controlled trial (RCT) to evaluate the efficacy of anorectal biofeedback therapy for functional constipation secondary to pelvic floor dyssynergia. Participants will be randomized to either six sessions of anorectal biofeedback or to six sessions of generalized biofeedback.

Participants will complete questionnaires at baseline, at completion of randomized treatment(12 weeks), and six months after completion of treatment to measure change in bowel habits, constipation severity, constipation-related quality of life, and constipation-related disability. An examination of psychosocial factors will also be conducted prior to treatment to distinguish which ones are predictive of biofeedback success for functional constipation.

Eligibility criteria: Inclusion Criteria:

* chronic constipation
* medical recommendation to undergo biofeedback training

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Madhulika G Varma, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hart SL, Lee JW, Berian J, Patterson TR, Del Rosario A, Varma MG. A randomized controlled trial of anorectal biofeedback for constipation. Int J Colorectal Dis. 2012 Apr;27(4):459-66. doi: 10.1007/s00384-011-1355-9. Epub 2011 Dec 9.
Clinical trial NCT02452957: Safety and Effectiveness of the Tornier Simpliciti™ Shoulder System in Shoulder Arthroplasty
Official title: A Prospective Multi-Center Study of the Safety and Effectiveness of the Tornier Simpliciti™ Shoulder System in Shoulder Arthroplasty
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Shoulder Osteoarthritis
Lead sponsor: Stryker Trauma and Extremities
Sponsor class: INDUSTRY
First posted: 2015-05-25
Enrollment: 0
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: Adult subject with clinical indication for total shoulder or hemi replacement due to primary diagnosis of osteoarthritis.

Brief summary: The aim of this observationnal post-marketing study is to provide additional information on the safety and effectiveness of Simpliciti™ system at 24 months post-shoulder arthroplasty , in usual surgical practice.


Eligibility criteria: Inclusion Criteria:

* A subject must meet all of the following inclusion criteria in order to enter the study:

  * Adult subject 18 years or older,
  * Clinical indication for total shoulder or hemi replacement due to primary diagnosis of osteoarthritis,
  * Scapula and proximal humerus must have reached skeletal maturity,
  * Willing and able to comply with the protocol,
  * Willing and able to personally sign the informed consent form,
  * Subject is legally competent, understands the nature, significance and implications of the clinical investigation, and is able to form a rational intention in the light of these facts.

Exclusion Criteria:

* A subject will not be eligible to participate in the study if any of the following conditions is present:

  * lack of sufficient sound bone to seat and support the implant, including that resulting from skeletal immaturity, osteoporosis or erosive arthritis,
  * Severe Walch grade B2 glenoid defined as \>60% posterior head displacement and \>20% posterior glenoid bone loss,
  * metal allergies or sensitivity,
  * infection at or near the site of implantation,
  * distant or systemic infection.

Primary outcomes:
measure: Number of patients with device related adverse events as a measure of safety
timeFrame: 24 months
Secondary outcomes:
measure: Change in the Range of Motions (ROM) as a measure of effectiveness
timeFrame: 24 months
measure: Change in the Constant Score as a measure of effectiveness
timeFrame: 24 months
measure: Change in the DASH Score as a measure of improvement in the patients' Quality of Life
timeFrame: 24 months
measure: Change in humeral cortical thickness as an evaluation of Stress Shielding
timeFrame: 24 months
Other outcomes:
Locations:
city: Hausham
country: Germany
facility: Krankenhaus Agatharied
Study officials:
affiliation: Stryker Trauma and Extremities
name: Steve A. Erickson
role: STUDY_DIRECTOR
affiliation: Krankenhaus Agatharied
name: Ulrich Brunner, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05541757: Rivaroxaban - Percutaneous Coronary Intervention
Official title: In-Vitro Evaluation of Anticoagulant Therapy Management When Urgent Percutaneous Coronary Intervention is Required in Rivaroxaban-Treated Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Atrial Fibrillation
Lead sponsor: Bursa Postgraduate Hospital
Sponsor class: OTHER
First posted: 2022-09-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with persistent or permanent AF had been using rivaroxaban 20 mg daily for at least one month

Brief summary: We investigated in-vitro the management of intraprocedural anticoagulation in patients requiring immediate percutaneous coronary intervention(PCI) while using regular direct oral anticoagulants(DOACs). Twenty-five patients taking 20mg of rivaroxaban once daily comprised the study group, while five healthy volunteers included the control group. In study group, a beginning(24-hours after the last rivaroxaban dose) examination was performed. Then, the effects of basal and four different anticoagulant doses(50IU/kg unfractionated heparin(UFH), 100IU/kg UFH, 0.5mg/kg enoxaparin, and 1mg/kg enoxaparin) on coagulation parameters were investigated at the 4th and 12th hours following rivaroxaban intake. Anticoagulant activity was assessed mainly by anti-factor Xa(anti-Xa) levels.


Eligibility criteria: Inclusion Criteria:

* patients using the direct oral factor Xa inhibitor rivaroxaban
* Atrial fibrillation

Exclusion Criteria:

* malignancy,
* coagulopathy,
* heart valve disease,
* active infection,
* chronic systemic or inflammatory disease,
* recent ACS or elective PCI,
* uncontrolled hypertension and diabetes,
* cerebrovascular accident,
* thyroid disorder,
* left ventricular systolic dysfunction (ejection fraction \<50%),
* glomerular filtration rate \<50 mL/min/1.73 m2,
* underweight and overweight (\<60 kg and \>100 kg),
* age \>75 years,
* hyperbilirubinemia and hypertriglyceridemia (\>350 mg/dl).

Primary outcomes:
measure: Anticoagulation level
timeFrame: 4 - 12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi
Study officials:
References:
Clinical trial NCT03017157: Subclinical Hypothyroidism and Acute Anterior Myocardial Infarction: Is it Cardio-protective or Not?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Injuries
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2017-01-11
Enrollment: 50
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: Patients who have suffered anterior myocardial infarction who have been hospitalized in our hospital's cardiac unit.

Brief summary: The study plans to investigate whether recovery of the heart function after acute anterior myocardial infarction is dependent upon improvement in thyroid gland functioning.


Eligibility criteria: Inclusion Criteria:

* Have suffered anterior myocardial infarction

Exclusion Criteria:

* Do not receive thyroid treatment
* No history of ischemic heart disease

Primary outcomes:
measure: Ejection Fraction Improvement
timeFrame: 40 days
measure: Improvement in thyroid function
timeFrame: 40 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
Clinical trial NCT03534557: FEV1/FEV6 and FEV6 as an Alternative for FEV1/FVC and FVC in Bolivian Subjects
Official title: FEV1/FEV6 and FEV6 as an Alternative for FEV1/FVC and FVC in the Detection of Airway Obstruction in a Small Group of Bolivian Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Copd
Keywords: spirometry
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2018-05-23
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD

Brief summary: Comparison of FEV1/FEV6 and FEV6 as an alternative for FEV1/FVC and FCV in the detection of airway obstruction in a Bolivian population

Detailed description: The data of consecutive adult smoker patients, referred to the Clínica del Pulmón (Santa Cruz, Bolivia), between May 2018 and June 2018, will be analyzed. All the patients are current or ex-smokers, complaining of dyspnea, cough or expectorations. Spirometry measurements will be performed with a Medisoft Body Box 5500 by one highly trained and experienced pulmonologist according to the guidelines of the ATS/ERS.

The criteria used to detect airway obstruction are either the fixed cut-off points according to GOLD recommendations (FEV1/FVC\<0.70) or the lower limit of normal (FEV1/FVC\<LLN). These indices will be compared to a fixed cut-off FEV1/FEV6 \<0.73 as proposed by Vandevoorde et al. or to a FEV1/FV6 ration \< LLN. Reference equations used are those of Caucasians from the NHANES III survey.

Statistical tests will be done using IBM SPSS 24 software. Cohen's κ will be used to determine if there is an agreement between the definitions of airway obstruction.

Eligibility criteria: Inclusion Criteria:

* adult smoker suspected of COPD

Exclusion Criteria:

* unable to perform spirometry

Primary outcomes:
measure: The aim of this preliminary study is to determine if the criteria of airway obstruction using FEV6 as a surrogate of FVC are transposable to a non-selected Bolivian population
timeFrame: one measurement lasts 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Cruz
country: Bolivia
facility: Clínica del Pulmón
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Giuseppe Liistro, MD,PhD
role: STUDY_DIRECTOR
References: