louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01677169: Effect of Noni Juice on Lipid Peroxidation-derived DNA Adducts in Heavy Smokers
Official title: Double Blind, Randomized, Placebo-controlled Clinical Trial of the Effect of Noni Juice on Lipid Peroxidation-derived DNA Adducts in Current Heavy Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: DNA Damage
Lead sponsor: Tahitian Noni International, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Illinois at Chicago
First posted: 2012-08-31
Enrollment: 317
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: PREVENTION

Brief summary: The purpose of this study was to determine if noni juice reduces lipid hydroperoxide (LOOH) and malondialdehyde (MDA) derived-DNA adducts, markers of oxidative DNA damage, in peripheral blood lymphocytes of cigarette smokers.


Eligibility criteria: Inclusion Criteria:

* 18 to 65 years in age, smoker of more than 20 cigarettes per day, a smoking history exceeding one year, and willing to complete a one month trial.

Exclusion Criteria:

* concurrent use, or use in the previous three months, of prescription medication or antioxidant vitamins

Primary outcomes:
measure: LOOH and MDA-DNA adducts
timeFrame: 1 month
Secondary outcomes:
measure: adverse events
timeFrame: 1 month
Other outcomes:
Locations:
city: Rockford
country: United States
facility: University of Illinois College of Medicine at Rockford
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Mian-ying Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03322969: Receiving Modified Chemotherapy Followed With Radical Resection After Neoadjuvant Chemotherapy
Official title: Receiving Modified Chemotherapy Followed With Radical Resection After Neoadjuvant Chemotherapy Versus Receiving the Original Chemotherapy in Locally Advanced Gastric Cancer: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Locally Advanced Gastric Cancer
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2017-10-26
Enrollment: 60
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: For patients undergoing postoperative therapy for locally advanced gastric cancer after neoadjuvant chemotherapy, we assessed the utility of graded histologic regression of \<50% as the criterion of treatment change. Sixty patients will be enrolled to randomize into two groups：receiving modified chemotherapy and receiving the original chemotherapy.

Detailed description: For patients undergoing postoperative therapy for locally advanced gastric cancer after neoadjuvant chemotherapy, we assessed the utility of graded histologic regression of \<50% as the criterion of treatment change. Sixty patients will be enrolled to randomize into two groups：receiving modified chemotherapy and receiving the original chemotherapy. Overall survival and disease-free survival will be observed between two groups.

Eligibility criteria: Inclusion Criteria:

* TNM stage of T2-T4 or positive regional lymph nodes, according to the American Joint Committee on Cancer (AJCC) 7.0 staging system, verified by enhanced abdominal computed tomography (CT) and/or endoscopic ultrasound (EUS), positron emission tomography (PET)/CT scan), with no evidence of distant metastases;
* ECOG performance status score ≤2 without serious heart, lung, liver, kidney, or hematological dysfunctions;
* age ≥18 years old;
* no previous chemotherapy, radiotherapy, or surgical treatment for gastric cancer;
* gastrectomy was performed after preoperative chemotherapy if imaging studies did not confirm disease progression (according to the Response Evaluation Criteria in Solid Tumors (RECIST)) ;
* signed the informed consent form.

Exclusion Criteria:

* All do not reach the inclusion criteria

Primary outcomes:
measure: disease free survival
timeFrame: 3 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
name: Lin Zhao, Doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03182569: Flexible Catheter for Insulin in Diabetes
Official title: Use of a Flexible Catheter for the Administration of Subcutaneous Insulin in Diabetic Ketoacidosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Ketoacidosis
Lead sponsor: Hospital General de Niños Pedro de Elizalde
Sponsor class: OTHER
First posted: 2017-06-09
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Use of a flexible subcutaneous catheter improves comfort in patients with DKA compared to the usual treatment with a metal needle.

Detailed description: Assess whether the use of a flexible subcutaneous catheter improves comfort in patients with DKA compared to the usual treatment with a metal needle.

Compare the metabolic evolution of patients with DKA using a flexible subcutaneous catheter for insulin administration vs. a metal needle.

Eligibility criteria: Inclusion Criteria:

* Patients aged 5 to 18 years, admitted with diagnoses of DKA. DKA is defined when patients meets all the following biochemical baseline criteria (before initial hydration):
* Glucose\> 200 mg / dl
* pH \< 7.3
* Bicarbonate \< 15mmol/l.

Exclusion Criteria:

* Patients referred from another institution with a different treatment, and those who requires intensive care on admission.

Primary outcomes:
measure: Comfort measured by a visual analogue scale for pain
timeFrame: between 10 to 14 hours
Secondary outcomes:
measure: Associated complications
timeFrame: 24 hours
measure: Metabolic stability according to lab determinations
timeFrame: between 10 to 14 hours
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital General de Niños Pedro de Elizalde
state: Constitucion
Study officials:
affiliation: Hospital General de Niños Pedro de Elizalde
name: Laura Beaudoin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hanas R, Adolfsson P, Elfvin-Akesson K, Hammaren L, Ilvered R, Jansson I, Johansson C, Kroon M, Lindgren J, Lindh A, Ludvigsson J, Sigstrom L, Wiik A, Aman J. Indwelling catheters used from the onset of diabetes decrease injection pain and pre-injection anxiety. J Pediatr. 2002 Mar;140(3):315-20. doi: 10.1067/mpd.2002.122470.
citation: Beaudoin ML, Torrents M, Tittarelli MF, Hamui M, Ibarra M, Ferraro M, Ferreira JP. Use of a Flexible Catheter for the Administration of Subcutaneous Insulin in Diabetic Ketoacidosis: A Feasibility Controlled Clinical Trial. Hosp Pediatr. 2021 Apr;11(4):396-400. doi: 10.1542/hpeds.2020-0063. Epub 2021 Mar 9.
Clinical trial NCT01989169: Pharmacokinetic Interaction Between SSP-004184 (SPD602) and Midazolam in Healthy Adult Subjects
Official title: A Phase 1, Randomized, Open Label, Crossover Study to Evaluate the Pharmacokinetic Interaction Between SSP-004184 (SPD602) and Midazolam in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2013-11-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: A Study to Evaluate the Pharmacokinetic Interaction Between SSP-004184 and Midazolam in Healthy Adult Subjects


Eligibility criteria: Inclusion Criteria:

* Normal healthy male and female volunteers between the ages of 18 and 65, inclusive
* Serum ferritin, hemoglobin and erythrocyte indices within normal range

Exclusion Criteria:

* Evidence of any active or chronic disease

Primary outcomes:
measure: Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of Midazolam
timeFrame: Study Periods 1 & 2: Within 60 minutes pre-dose, and Post-dose 0.167, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hours.
measure: Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measureable Concentration (AUClast) of Midazolam
timeFrame: Study Periods 1 & 2: Within 60 minutes pre-dose, and Post-dose 0.167, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hours.
measure: Maximum Plasma Concentration (Cmax) of Midazolam
timeFrame: Study Periods 1 & 2: Within 60 minutes pre-dose, and Post-dose 0.167, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Clinical Pharmacology of Miami, Inc.
state: Florida
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06199869: Cardiovascular Patients With no Standard Modifiable Risk Factors
Official title: Absence of Standard Modifiable Risk Factors Among 5000 Middle Eastern Patients With Atherosclerotic Cardiovascular Disease: Clinical Profiles and Prevalence of Other Risk Factors and Comorbidities
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Risk Factors
Keywords: Atherosclerotic cardiovascular disease
Standard modifiable risk factors (SMuRFs)
Middle Eastern population
Lead sponsor: Jordan Collaborating Cardiology Group
Sponsor class: OTHER
Collaborators: name: The Jordan Cardiovascular Research Group JoCVRG
name: Yarmouk University School of Medicine
First posted: 2024-01-10
Enrollment: 5540
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Adults (18 years of age and older) with ASCVD.
2. ASCVD includes:

   1. Coronary heart disease
   2. stroke
   3. peripheral artery disease.

Brief summary: A growing number of patients develop atherosclerotic cardiovascular disease (ASCVD) despite the absence of standard modifiable risk factors (SMuRF-less). There is scarcity of studies that address this issue in the Middle Eastern population.

Detailed description: Atherosclerotic coronary artery disease (ASCAD) claims millions of lives annually on a global level and is the leading cause of death in the Middle East. There are four standard modifiable cardiovascular risk factors (SMuRFs): hypertension, type 2 diabetes mellitus, dyslipidemia, and smoking. These are very common in the Middle East and are crucial to be screened for and addressed in an affective manner.

However, an increasing proportion of patients with ASCVD have none of these individual factors (SMuRF-less). Globally, this proportion comprises 11.6% of individuals with stable coronary disease and heart attack. No prior study has addressed the issue of the prevalence of SMuRF-less patients among the whole population of individuals with ASCVD in the Middle East.

Eligibility criteria: Inclusion Criteria:

* A diagnosis of atherosclerotic cardiovascular disease (ASCVD).
* Ability to fill the clinical form that evaluates the presence or absence of cardiovascular risk factors including the 4 SMuRFs.

Exclusion Criteria:

* Atherosclerotic cardiovascular disease diagnosed before the age of 18 years.
* Inability to give detailed history of prespecified risk factors.

Primary outcomes:
measure: Prevalence of patients who do not any of the four SMuRFs
timeFrame: Up to 4 weeks after study enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Istishari Hospital
city: Irbid
country: Jordan
facility: Yarmouk University School of Medicine
Study officials:
References:
Clinical trial NCT06120569: Evaluate the Role of Soleus Muscle Exercise in Glycaemic Control in Diabetic Kidney Disease Patients
Official title: Evaluate the Role of Soleus Muscle Exercise in Glycaemic Control in Diabetic Kidney Disease Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetic Kidney Disease
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Evaluate the role of Soleus muscle exercise in management diabetic kidney disease

Detailed description: management of diabetic kidney disease. To enhance their glycemic control, diabetic patients are advised to perform 150 minutes per week of moderate-to-vigorous aerobic activity Diabetic patients with regular physical activity have reduced daily insulin dose with more glycemic control. In addition to glycemic control, it has also been postulated that the addition of brief intervals of high intensity, sprint -type exercise to aerobic exercise can decrease the risk of late nocturnal hypoglycemic episodes Marc T. Hamilton et al., 2022, reported that the human soleus muscle could raise local oxidative metabolism to high levels for hours without fatigue, during a type of soleus-dominant activity while sitting (soleus push up exercise), even in unfit volunteers. They reported that soleus push up exercise can improve systemic VLDL-triglyceride and glucose homeostasis by a large magnitude, e.g., 52% less postprandial glucose excursion (∼50 mg/dL less between ∼1 and 2 h) with 60% less hyperinsulinemia. Muscle biopsies revealed there was minimal glycogen use. This can be explained that the soleus doesn't rely completely on intramuscular glycogen, Instead, it uses a mixture of fuels from glucose and lipoproteins.

Eligibility criteria: Inclusion Criteria:

* Patients age 18-60 yrs.,
* patients with Diabetic kidney disease, not on dialysis
* with stabilized diabetic treatment regimen for 3 months before participating in the study

Exclusion Criteria:

* advanced osteoarthritis of lower limb joints
* advanced poly neuropathic patients
* CKD type V on dialysis
* Diabetic Foot
* hemophilia
* bleeding tendency
* AKI
* other causes of chronic kidney disease
* patients refuse to participate in the study

Primary outcomes:
measure: HbA1C less than 7%
timeFrame: One year
Secondary outcomes:
measure: ratio of albumin (mcg/L) to creatinine (mg/L)ratio
timeFrame: One year
Other outcomes:
Locations:
Study officials:
affiliation: Superviosor
name: Samir Kamal, Ass prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT00417469: A Study to Compare Subject Comfort During and After Injections With the Study Products and the Safety of the Non-FDA Approved Product for the Correction of Nasolabial Folds (NLFs)
Official title: A Single-Blind, Randomized, Single-Center Evaluation of Procedural and Post Procedural Pain Experienced With Injections of NADG With Lidocaine Injectable Gel as Compared to Captique® Injectable Gel in Subjects Undergoing Cutaneous Correction of Nasolabial Folds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Facial Wrinkles
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-01-01
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to compare subject comfort during and after injection with NADGL and Captique® Injectable Gel, in the nasolabial folds. Captique® is an FDA-approved product without lidocaine and is manufactured by Genzyme Biosurgery (Ridgefield, NJ). NADGL is a new product (not FDA approved) with lidocaine and is also manufactured by Genzyme Biosurgery. We do not know which of these treatments results in less pain during and after injection. The safety of NADGL is also being studied.

Detailed description: 45 subjects are planned; a portion of these subjects will have skin of color

Eligibility criteria: Inclusion Criteria:

* bilateral nasolabial folds with severity score of 3 or 4 on the 6 point scale.

Exclusion Criteria:

* pregnant/lactating women
* subjects who have an allergy to lidocaine or other amide-type anesthetics

Primary outcomes:
measure: To evaluate the pain experienced during and after the injection procedure for NADGL as compared to Captique® Injectable Gel in subjects undergoing cutaneous correction of nasolabial folds (NLFs).
Secondary outcomes:
measure: To evaluate the safety of NADGL.
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00148369: A Multi-Center, Observational Safety Registry of Subjects With Idiopathic Parkinson's Disease Previously Treated With Intraputaminal Infusion of Liatermin
Official title: A Multi-Center, Observational Safety Registry of Subjects With Idiopathic Parkinson's Disease Previously Treated With Intraputaminal Infusion of Liatermin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Parkinson's Disease
Lead sponsor: Amgen
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2005-09-08
Enrollment: 31
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with idiopathic Parkinson's Disease

Brief summary: The primary purpose of this study is to evaluate clinical and serologic outcomes after the discontinuation of liatermin therapy as assessed by development of new clinical conditions beyond those expected in patients with advancing Parkinson's disease. In addition, the development or resolution of anti-r-metHuGDNF binding and neutralizing antibodies will be monitored.


Eligibility criteria: Inclusion Criteria: - Subjects must have a diagnosis of bilateral, idiopathic Parkinson's Disease who have been enrolled and treated with intraputaminal infusion of liatermin in a previous Amgen/Medtronic-sponsored trial (protocols 20010109 or 20030160) or the Bristol open-label study - At time of implant (Study 20030168), subjects need to have been 35 to 70 years of age

Primary outcomes:
measure: Adverse Events
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04754269: A Mobile Health Intervention to Reduce Sweet Beverage Consumption in Latino Children
Official title: Randomized Controlled Trial of an M-health Intervention to Reduce Sweet Beverage Consumption Among Low-income Latino Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Child Obesity
Child Development
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2021-02-15
Enrollment: 200
Sex: ALL
Minimum age (years): 12
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Sugar-sweetened beverage consumption is a major contributor to childhood obesity, caries, fatty liver disease, and Type 2 diabetes. Latino children are more likely to consume sugar-sweetened beverages (SSBs) and to suffer from all of the aforementioned conditions. Reading out loud to children from birth through age 5 is critical for the promotion of language and early literacy skills. Children whose parents read aloud to them are more likely to start school with the skills required for early reading success. This is important as reading proficiency in third grade is the best predictor of high school graduation and career success. Latino children are less likely to be read to than non-Hispanic white children and at higher risk of entering kindergarten without critical early literacy skills. Thus, there is a pressing need for interventions to reduce SSB consumption among Latino children as well as interventions that promote reading out loud. Primary care is an optimal setting for such interventions. However, multiple demands on providers' time make it difficult to rely on in-person interventions. For this reason, it is critical to test intervention designs that do not rely directly on health care providers and that can be delivered remotely if needed. The investigators have developed two m-health interventions for Latino parents, one that promotes optimal beverage consumption patterns and one that promotes reading out loud to children. The purpose of this study is to test the impact of these interventions on child beverage intake patterns and the frequency with which parents read to children.


Eligibility criteria: Inclusion Criteria:

* Parent identifies child as Latino/a/x
* Child age 1 to 5 (12 to 59 months)
* Parent has a cell phone that can receive text messages
* Parent speak English or Spanish

Exclusion Criteria:

• Child does not feed by mouth

Primary outcomes:
measure: Change in 7-day child consumption of sugar-sweetened beverages and 100% fruit juice
timeFrame: Change from baseline to 3-month follow-up
Secondary outcomes:
measure: Change in 7 day total parent intake of sugar-sweetened beverages
timeFrame: Change from baseline to 3-month follow-up
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco General Hospital Children's Health Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Amy L Beck, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05835869: Chorioretinal Vascularization and Electrophysiological Changes After Carotid Revascularization
Official title: Electrophysiological and Morphofunctional Changes of Retina and Choroid Vascularization After Carotid Endarterectomy, a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carotid Stenosis
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-04-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study is to evaluate changes in retinal function by means of electro-functional examinations of the retina and to associate them with any changes in chorioretinal vascular density occurring in the ipsilateral eye after carotid revascularization surgery.


Eligibility criteria: Inclusion Criteria:

* age \>18 years old
* Carotid stenosis diagnosis with indication to perform carotid endarterectomy
* informed consent form signing

Exclusion Criteria:

* age \<18 years old
* recurrent intraocular inflammation
* retinal disease
* optic neuropathy, optic nerve drusen, opacity of the dioptric means in the pre- or post-operative period that prevents the acquisition of high-resolution images
* unstable fixation
* spheric refractive error \> +/- 6 D spheric and/or +/- 3 D cylinder
* history of prior ocular surgery
* refusal of signing informed consent form

Primary outcomes:
measure: Functional retinal changes
timeFrame: 1 week and 3 months
Secondary outcomes:
measure: Retinal vascular density changes
timeFrame: 1 week and 3 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Policlinico Agostino Gemelli IRCCS
state: RM
Study officials:
affiliation: Policlinico Agostino Gemelli IRRCS
name: Antonio Baldascino, MD
role: PRINCIPAL_INVESTIGATOR
References: