louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03433196: Efficacy and Safety Study of the HS-25 Combination With Atorvastatin in Subjects With Hypercholesterolemia in Coronary Heart Diseases
Official title: Randomized,Double Blind,Double Dummy, Multi-center Study of Efficacy and Safety of HS-25 Combination With Atorvastatin in Subjects With Hypercholesterolemia in Coronary Heart Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia in Coronaory Heart Disease
Lead sponsor: Zhejiang Hisun Pharmaceutical Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2018-02-14
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the efficacy of HS-25 (20mg) in reducing low density lipoprotein-cholesterol (LDL-C) levels after a 12-week period of treatment in combination with Atorvastatin in subjects with hypercholesterolemia and coronary heart diseases; To determine the safety of HS-25 (20mg) combination with Atorvastatin in subjects with hypercholesterolemia and coronary heart diseases


Eligibility criteria: Inclusion Criteria:

* Diet control for 14 weeks, Atorvastatin 10mg once daily for 6 weeks or above;
* The average of both qualifying values must be in the range of 2.07 mmol/L to 3.36 mmol/L. Run-in (Visit 2 and Visit 3) and the Visit 3 value must be within 12% of the value at Visit 2, higher or lower;
* Must meet the one of diseases as following:

  1. Subjects who have stable coronary heart disease;
  2. Subjects who diagnosed ischemic stroke in stable condition;
  3. Subjects who diagnosed as Diabetes mellitus

Exclusion Criteria:

* history of Severe Endiocrine disease (for example Thyroid function abnormal);
* History of advanced cancer
* Arrhythmias need to be treated by medications history of Hemorrhagic stroke;
* Cardiac dysfunction;
* Unstable ASCVD;
* History of organ transplant;
* Hypersensitive to HS-25 or place;
* uncontrolled or new diagnosed diabetes mellitus;
* HCV and HBsAg positive

Primary outcomes:
measure: Percent change of LDL-C
timeFrame: 2,4,8,12 weeks
Secondary outcomes:
measure: Percent change of Non-HDL-C
timeFrame: 2,4,8,12 weeks
measure: Percent change of TC,TG,ApoB,ApoAI
timeFrame: 2,4,8,12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Peking University First Hospital
name: Litong Qi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01607996: Effect of Epidural Anesthesia on Pancreatic Perfusion and Clinical Outcome in Patients With Severe Acute Pancreatitis
Official title: Phase 1 Study of Epidural Anesthesia on Pancreatic Perfusion and Clinical Outcome in Patients With Severe Acute Pancreatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Severe Acute Pancreatitis
Keywords: Epidural anesthesia
pancreatic perfusion
pancreatic necrosectomy
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2012-05-30
Enrollment: 35
Sex: ALL
Minimum age (years): 16
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the safety, the potential beneficial effect of epidural anesthesia on pancreatic perfusion and clinical outcome of patients with severe acute pancreatitis.

Detailed description: High mortality in severe acute pancreatitis (AP) is linked to necrosis of the gland. Animal studies showed that epidural anesthesia (EA) restores pancreatic microcirculation and decreases the severity of AP. The aim of the study is to evaluate the safety of EA, its effect on pancreatic perfusion and clinical outcome of patients with AP.

Eligibility criteria: Inclusion Criteria:

* Acute pancreatitis with Ranson Criteria over 2, and/or CRP over 100, and or pancreatic necrosis on CT scan

Exclusion Criteria:

* Coagulation disorders
* Skin infection of the vertebral region

Primary outcomes:
measure: Number of patients with adverse events related to epidural anesthesia
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 to 5 weeks
measure: Pancreatic perfusion measured by computerized tomography
timeFrame: On day 0 and day 2 or 3 after hospital admission
Secondary outcomes:
measure: Clinical outcome
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 to 5 weeks
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University Hospital Geneva
Study officials:
References:
citation: Demirag A, Pastor CM, Morel P, Jean-Christophe C, Sielenkamper AW, Guvener N, Mai G, Berney T, Frossard JL, Buhler LH. Epidural anaesthesia restores pancreatic microcirculation and decreases the severity of acute pancreatitis. World J Gastroenterol. 2006 Feb 14;12(6):915-20. doi: 10.3748/wjg.v12.i6.915.
Clinical trial NCT02547896: Effectiveness of Diclofenac and Its Association to Codeine After Lower Third Molar Extraction.
Official title: Effectiveness of Non-steroidal Anti-inflammatory Diclofenac and Its Association to the Opioid Codeine for Pain, Swelling and Trismus in the Bilateral Mandibular Third Molar Extraction With a High Degree of Difficulty Model.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Impacted Third Molar Tooth
Keywords: codeine
diclofenac
impacted third molar tooth
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2015-09-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: It will be evaluated the clinical efficacy of Diclofenac 50mg (NSAID) compared to its association with Codeine 50mg (opioid) administered in 50 patients requiring extraction of two third molars. After assessing the research parameters, a comparative data analysis, along with the proper application of statistical tests, will provide the basis for an evaluation of both efficiency medications used.

Detailed description: This research will evaluate the clinical efficacy of Diclofenac 50mg (NSAID) compared to its association with Codeine 50mg (opioid) administered in 50 patients aged less than 18 and requiring extraction of two third molars (with very similar positions, whose degree of difficulty is high). It will be assessed the following parameters: 1) onset and duration of surgery after administration of local anesthetic, 2) open mouth prior to surgery, on the 2nd day after the operation and on the 7th day after surgery (removal points), 3) subjective assessment of pain using a visual analog scale, 4) measurement of facial edema in the second day after the operation and on the 7th day after surgery (as compared with the measurements obtained before surgery) and 5) the incidence, type and severity of adverse reactions. The analysis comparative data, along with the proper application of statistical tests, provide the basis for an evaluation of both efficiency medications used.

Eligibility criteria: Inclusion Criteria:

* Impacted lower third molar
* not in use of NSAID or opioids in the last one month

Exclusion Criteria:

* Local anesthetics allergy,
* History of gastrointestinal bleeding or ulcers,
* Kidney disease,
* Asthma,
* Allergy or sensitivity to aspirin or any other NSAID or opioids,
* Pregnant or nursing woman,
* Patients using antidepressant, diuretic or aspirin,
* Patients under treatment to quit drugs

Primary outcomes:
measure: Higher pain control after lower third molar surgeries with codeine + diclofenac
timeFrame: Seven days after surgery
Secondary outcomes:
measure: Adverse effects
timeFrame: Seven days after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Bauru School of Dentistry - University of Sao Paulo - USP
name: Paulo Z Goncalves, DDS
role: STUDY_CHAIR
References:
Clinical trial NCT01783496: Thermage CPT for Treatment of Facial and Neck Laxity
Official title: Clinical Comparison of the Thermage CPT™ System's Framed and Pattern Tips for Treatment of Facial and Neck Laxity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Aging
Lead sponsor: Valeant Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-02-05
Enrollment: 50
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study to evaluate treatment with the Thermage CPT system for facial and neck laxity.


Eligibility criteria: Inclusion Criteria:

* 25 - 65 years of age
* Moderate facial and neck laxity
* Subject has the ability to follow the study instructions, is willing to be available on the specific required study visit days, and is willing to complete all study visit procedures and assessments.
* Subject must understand the research nature of this study and sign an Institutional Review Board (IRB)-approved informed consent prior to the performance of any study specific procedure or assessment.
* Subject agrees not to undergo excluded procedures on the face and neck for the duration of study.

Exclusion Criteria:

* Subject is pregnant or breast feeding, or trying to become pregnant for three months prior to or during the study.
* Pacemaker, internal defibrillator, or other implanted electronic device
* Subject has an active localized infection in the treatment area(s) or an uncontrolled systemic infection.
* Subject has had prior cosmetic procedures on the treatment area(s) within six months of the baseline visit.

Primary outcomes:
measure: Improvement in Laxity
timeFrame: 6 months
Secondary outcomes:
measure: Improvement in Skin Laxity (Subject Self-assessed)
timeFrame: 6 months
measure: Subject Satisfaction With Treatment Results
timeFrame: 6 months
Other outcomes:
Locations:
city: Hayward
country: United States
facility: Solta Medical Aesthetic Center
state: California
Study officials:
name: Ronald Wheeland, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01670396: Genetics Study of In-stent Restenosis
Official title: G Protein β3 Subunit (GNB3) Polymorphism and Restenosis of Coronary Drug-eluting Stents
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Keywords: coronary stent implant
polymorphism
G protein
drug-eluting stent
restenosis
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2012-08-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospitalized patients

Brief summary: The investigators hypothesized that genetic variants of G protein influence the development of restenosis and clinical outcome of patients receiving drug-eluting stents (DES).

Detailed description: Although drug-eluting stents (DES) have reduced restenosis rates compared with bare-metal stents, the restenosis rate is still high in the high-risk group. G protein plays important roles in the signal transduction leading to vascular smooth muscle proliferation. The initial and subsequent studies suggest that the T allele of C825T polymorphism is associated with enhanced transmembrane signaling via Gi proteins.

Eligibility criteria: Inclusion Criteria:

* Patients who underwent follow-up angiography. All the patients must had been implanted with DES during the last two years.

Exclusion Criteria:

* For the non-ISR group, the patients underwent follow-up angiography less than 6 months away from stent implanting.

Primary outcomes:
measure: In-stent restenosis
timeFrame: 6-24months after stent implanting
Secondary outcomes:
measure: target lesion revascularization (TLR)
timeFrame: 6-24months after stent implanting
measure: re-myocardial infarction
timeFrame: 6-24months after stent implating
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital
Study officials:
References:
Clinical trial NCT06215196: Effectiveness and Safety of Semaglutide Combined With Dietary Fiber (Soloways) in Adults With Overweight or Obesity
Official title: Effectiveness and Safety of Semaglutide Combined With Dietary Fiber (Soloways) in Adults With Overweight or Obesity: A Randomized, Placebo-Controlled, Double-Blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: Semaglutide
Weight Loss
Obesity
Appetite Suppression
Lead sponsor: S.LAB (SOLOWAYS)
Sponsor class: OTHER
Collaborators: name: Center of New Medical Technologies
name: Triangel Scientific
First posted: 2024-01-22
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical trial investigated the combined effects of Semaglutide and a fiber supplement (glucomannan, inulin, psyllium) on weight loss in adults with overweight or obesity. Participants, aged 18-65 with a BMI ≥30 or ≥27 with comorbidities, were randomized into two groups: one receiving Semaglutide with active fiber supplements and the other with Semaglutide and placebo, over a 180-day period. Key endpoints included percentage change in body weight, BMI, body composition, safety, and appetite control, with a focus on evaluating the additive effects of dietary fibers in enhancing Semaglutide's efficacy.


Eligibility criteria: Inclusion Criteria:

* BMI ≥30, or ≥27 with comorbidities.

Exclusion Criteria:

* Serious chronic illnesses.
* History of bulimia or anorexia.
* Pregnancy or lactation.

Primary outcomes:
measure: Percentage change in body weight from baseline
timeFrame: 180 days
measure: Achievement of a reduction in body weight of 5% or more from baseline.
timeFrame: 180 days
Secondary outcomes:
measure: BMI change
timeFrame: 180 days
measure: fat mass change
timeFrame: 180 day
measure: Safety evaluated by recording any adverse events.
timeFrame: 180 days
measure: fat-free mass change
timeFrame: 180 days
measure: visceral fat rating change
timeFrame: 180 days
measure: total body water change
timeFrame: 180 days
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Center of New Medical Technologies
state: Novosibisk Region
Study officials:
References:
Clinical trial NCT01523496: Vitamin D Supplementation in HIV Youth
Official title: Vitamin D Supplementation and HIV-related Complications in Children and Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: HIV Infections
Keywords: HIV
Vitamin D Deficiency
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: Emory University
First posted: 2012-02-01
Enrollment: 190
Sex: ALL
Minimum age (years): 8
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the correct dose of Vitamin D to give to prevent HIV related complications.

Detailed description: The purpose of the this study was to compare control dose of vitamin D (low dose of 600 IU/d) to supplementation dose (medium dose of 2000 IU/d or higher doses of vitamin D of 4000 IU/d) on HIV-related comorbidities including immune activation, inflammation, cardiovascular diseases, and metabolic complications in HIV-infected youth.

Eligibility criteria: Inclusion Criteria:

* Ages 8-25
* Documented HIV-1 infection
* On stable antiretroviral therapy for \> 3 months
* Cumulative antiretroviral therapy of at least 6 months
* 25(OH)D level \< 30 ng/ml at screening

Exclusion Criteria:

* \> 400 IU daily regular vitamin D intake
* Parathyroid/calcium disorders
* Active malignancy
* Pregnancy/intent to become pregnant/breastfeeding
* Chronic infectious/inflammatory conditions
* Creatinine clearance \< 50 ml/min
* Hemoglobin \< 9.0 g/dL
* Aspartate aminotransferase and alanine aminotransferase \> 2.5 upper limit of normal
* Diabetes requiring hypoglycemic agents
* Known coronary artery disease
* Inability to swallow pills

Primary outcomes:
measure: Changes in Serum 25(OH)D3 Levels
timeFrame: 6 months
Secondary outcomes:
measure: Changes in Vitamin D Binding Protein (VDBP)
timeFrame: 6 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Children's Center
state: Georgia
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Grace McComsey, MD, FIDSA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eckard AR, O'Riordan MA, Rosebush JC, Lee ST, Habib JG, Ruff JH, Labbato D, Daniels JE, Uribe-Leitz M, Tangpricha V, Chahroudi A, McComsey GA. Vitamin D supplementation decreases immune activation and exhaustion in HIV-1-infected youth. Antivir Ther. 2018;23(4):315-324. doi: 10.3851/IMP3199.
citation: Eckard AR, Rosebush JC, O'Riordan MA, Graves CC, Alexander A, Grover AK, Lee ST, Habib JG, Ruff JH, Chahroudi A, McComsey GA. Neurocognitive dysfunction in HIV-infected youth: investigating the relationship with immune activation. Antivir Ther. 2017;22(8):669-680. doi: 10.3851/IMP3157.
citation: Hileman CO, Overton ET, McComsey GA. Vitamin D and bone loss in HIV. Curr Opin HIV AIDS. 2016 May;11(3):277-84. doi: 10.1097/COH.0000000000000272.
Clinical trial NCT02200796: Role of Dietary Protein on Satiety, Food Intake and Thermic Effect of Food
Official title: Role of Dietary Protein in a Familiar Breakfast Meal on Subjective Satiety, Food Intake and Thermic Effect of Food in Normal Weight and Overweight/Obese Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Keywords: Dietary Protein
Satiety
Food Intake
Thermic Effect of Food
Diet Induced Thermogenesis
Lead sponsor: Toronto Metropolitan University
Sponsor class: OTHER
First posted: 2014-07-25
Enrollment: 17
Sex: ALL
Minimum age (years): 9
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Objectives: To determine the effect of protein content of familiar breakfast meals on subjective appetite, food intake (FI), glycemic response and Thermic Effect of Food (TEF) in normal weight (NW) and overweight (OW)/obese (OB) children.

Specific Objectives:

1a.To determine the effect of familiar breakfast meals (450 kcal containing eggs and varying in protein content (15, 30, and 45g) on subjective appetite, glycemic response and food intake at a test meal 4 h later in NW and. OW/OB children.

1b. To describe the effect of isocaloric (450 kcal) familiar breakfasts either high in protein (optimal protein from Objective 1a) or low in protein on TEF and substrate utilization over 5 h in NW and OW/OB children.

Detailed description: Hypothesis: The investigators hypothesize that increasing the high-quality protein content of a breakfast meal will dose dependently increase subjective satiety, lower FI and glycemic response, and increase the TEF in both NW and OW/OB children.

Eligibility criteria: Inclusion Criteria:

* Boys and girls between the ages of 9 and 14 y
* Only peri-pubertal girls
* Normal body weight (between the 5th and 85th BMI percentile for age and gender)
* OW/OB (\>85th BMI percentile for age and gender)

Exclusion Criteria:

* Food sensitivities
* Food allergies
* Dietary restrictions
* Health, learning, emotional or behavioural problems
* On any medication

Primary outcomes:
measure: 1a) Ad libitum food intake (in kcal)
timeFrame: Four hours after breakfast
Secondary outcomes:
measure: 1b) The thermic effect of a high versus low protein meal
timeFrame: Resting energy expenditure (REE) at baseline and up to five hours post test meal
measure: Subjective Appetite
timeFrame: Assessed every 15 min for 4 h
measure: Blood glucose response
timeFrame: Measures at 15, or 60 min intervals for 4 h
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Ryerson University, FIRST Labaratory. 350 Victoria Street
state: Ontario
Study officials:
References:
Clinical trial NCT05494996: Psychometric Properties of the Chinese Version of the Five-item Relationship Satisfaction Scale
Official title: Psychometric Properties of the Chinese Version of the Five-item Relationship Satisfaction Scale
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Relationship, Family
Keywords: Factor Analysis, Statistical
Psychometrics / methods
Family Relations / psychology*
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-08-10
Enrollment: 278
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total number of 278 spouses/partners who are married or in a romantic relationship.

Brief summary: The aims of this study are to translate the five-item relationship satisfaction scale（RS5) into Chinese and assess its psychometric properties among Chinese patients.

Detailed description: This study will use forward translation, reverse translation, and comprehensive methods to translate the RS5 scale into Chinese ,which will be more in line with the Chinese language and cultural environment. This study will also verify its reliability and validity in a large sample population to form a formal version of the scale. The scale will provide an effective tool for evaluating the degree of relationship satisfaction in China.

Eligibility criteria: Inclusion Criteria:

* ≥18 years old;
* Participants who are married or in a romantic relationship;
* Be able to read and communicate in Chinese.

Exclusion Criteria:

* Those who are unable to communicate due to serious mental or physical illnesses such as deafness, confusion caused by mental illness, etc.

Primary outcomes:
measure: Relationship satisfaction
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: XIAW
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Wei Xia, PhD
role: PRINCIPAL_INVESTIGATOR
References: