louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05823597: Reducing Dietary Added-Sugar Consumption During the Transition to College
Official title: Effects of a Novel Intervention to Reduce Dietary Added-Sugar Consumption During the Transition to College: A Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Added Sugar Consumption
Keywords: added sugar
eating behavior
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2023-04-21
Enrollment: 702
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster-randomized controlled trial
Primary purpose: PREVENTION

Brief summary: The goal of this cluster randomized controlled trial was to compare the effects of two single-session interventions (sugar-intensive vs. general health control) on added sugar intake, motivation to reduce sugar consumption, and factual knowledge about added sugar 6 weeks later, in a sample of first-semester undergraduates.

Detailed description: Excessive sugar consumption is recognized as a critical public health concern. For many young adults, the transition to college presents both risk and a promising opportunity to encourage formation of healthy dietary habits. Capitalizing on this window of opportunity, we conducted a cluster-randomized controlled trial to compare the effects of two single-session interventions on added sugar intake in a sample of first-semester undergraduates. Participants received either an intervention primarily focused on reducing added sugar consumption or a general health behavior intervention with units on physical activity, sleep, and healthy diet. Participants' added sugar intake, motivation to reduce sugar consumption, and factual knowledge about added sugar intake were compared at follow-up.

Eligibility criteria: Inclusion Criteria:

* Students aged 18 years and older, enrolled in online sections of a required transition-to-college course at a large public university in the Southwest region of the U.S. All students in online sections of this class received the single-session intervention during their normal class period, early in the Fall 2020 semester, and were eligible to participate.

Exclusion Criteria:

* Age \< 18 years.

Primary outcomes:
measure: Change from Baseline Added-Sugar Consumption at 6 Weeks
timeFrame: 6 weeks post-intervention
Secondary outcomes:
measure: Motivation to reduce added-sugar consumption
timeFrame: 6 weeks post-intervention
measure: Added sugar factual knowledge
timeFrame: 6 weeks post-intervention
measure: Change from Baseline Sleep at 6 Weeks
timeFrame: 6 weeks post-intervention
measure: Change from Baseline Exercise at 6 Weeks
timeFrame: 6 weeks post-intervention
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Arizona State University
state: Arizona
Study officials:
References:
Clinical trial NCT04536597: Quince Seed Jelly and Breast Milk on Nipple Fissures
Official title: The Effects of Quince Seed Jelly and Breast Milk on Nipple Fissures During Early Postpartum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primiparity
Postpartum
Keywords: breast milk
early postpartum period
nipple fissures
midwifery
quince seed jelly
Lead sponsor: Cumhuriyet University
Sponsor class: OTHER
First posted: 2020-09-02
Enrollment: 426
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Background: In various experimental or clinical studies, it has been reported that the jelly made from the quince seed is effective in healing wounds (attributed to the antioxidants, which increased fibroblast activity and collagen production, facilitated the formation of granulation tissue and increased blood circulation) and has no side effects or contraindications.

Purpose: To evaluates the effects of quince seed jelly and breast milk on nipple fissures.

Methods: Randomised controlled experimental study.


Eligibility criteria: Inclusion Criteria:

* primiparity,
* those having no nipple problems and allergy history
* volunteered to participate in the study

Exclusion Criteria:

* nipple problems and allergy history
* multiparity

Primary outcomes:
measure: Nipple pains and fissures
timeFrame: between the 1st and 10th days of the postpartum period
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01203397: Safety And Efficacy Study Of Topic Mucopolysaccharide Polysulfate In The Superficial Varicose Veins Treatment
Official title: PHASE III OF SAFETY AND EFFICACY STUDY OF TOPIC MUCOPOLYSACCHARIDE POLYSULFATE 5MG/G IN THE SUPERFICIAL VARICOSE VEINS TREATMENT
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: VARICOSE VEINS
Keywords: SUPERFICIAL VARICOSE VEINS
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2010-09-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the safety, tolerability and effectiveness of mucopolysaccharide polysulfate in the treatment of superficial varicose veins


Eligibility criteria: Inclusion Criteria:

* Patients must be able to understand the study procedures, agree to participate, and give written consent.
* Patients must be able to follow the study medication regimen.
* Patients with inflammatory process in superficial veins for more than 72 hours.
* Presence of symmetric lesions to compare one side to the other.

Exclusion Criteria:

* Pregnancy or risk of pregnancy.
* Lactation.
* Use of topical or systemic anti-inflammatory, antihistamine or immunosuppressive drugs within the last 48 hours prior to the study
* Any alteration at other deep veins.
* History of atopy or allergic diseases.
* History of allergy to any component of the formulations.
* Other conditions considered by the investigator as reasonable for non-eligibility.

Primary outcomes:
measure: Efficacy - Symptoms reduction
timeFrame: Evaluation time: 3 - 7 - 10 and 15 days
Secondary outcomes:
measure: Efficacy - patient evaluation
timeFrame: 15 days
Other outcomes:
Locations:
city: Osasco
country: Brazil
facility: Medcin Instituto Da Pele
state: SÃO Paulo
Study officials:
affiliation: Medcin Instituto da Pele
name: FLAVIA ADDOR
role: PRINCIPAL_INVESTIGATOR
affiliation: EMS
name: Felipe Pinho, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00103597: Efficacy of Therapeutic Interventions for Orthostatic Hypotension in Parkinson's Disease and Multiple System Atrophy
Official title: Efficacy of Therapeutic Interventions for Orthostatic Hypotension in Parkinson's Disease and Multiple System Atrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Parkinson's Disease
Multiple System Atrophy
Orthostatic Hypotension
Keywords: Orthostatic hypotension
Parkinson's Disease
Lead sponsor: Royal Brisbane and Women's Hospital
Sponsor class: OTHER_GOV
First posted: 2005-02-14
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Patients with Parkinson's Disease or Multiple System Atrophy (MSA), and symptoms of orthostatic hypotension, are eligible for the study. Each patient will have three weeks of conservative therapy, three weeks of therapy with fludrocortisone, and three weeks of therapy with domperidone. Autonomic testing, a symptom questionnaire, bedside blood pressure testing, and Unified Parkinson Disease Rating Scale (UPDRS) will be performed after each intervention.

Detailed description: Enrolled patients, ages 40-95, must have Parkinson's or MSA, diagnosed by a neurologist, and symptoms of orthostatic hypotension. Each patient will fill out two validated questionnaires to determine if they are candidates for the study. Baseline patient details, such as their medications and UPDRS, will be recorded. Medications must be held stable during the period of the study.

Each patient will then have three weeks of conservative therapy, three weeks of therapy with fludrocortisone, and three weeks of therapy with domperidone. Autonomic testing, a symptom questionnaire, bedside blood pressure testing, and UPDRS will be performed after each intervention.

Eligibility criteria: Inclusion Criteria:

* Patients residing in Queensland Australia
* Age 40-95
* Parkinson's Disease or MSA diagnosed by a neurologist
* Symptoms of orthostatic hypotension, as defined by 2 validated questionnaires

Exclusion Criteria:

* Patients with acute cardiomyopathy or cardiac condition
* Patients unable to give consent
* Patients not stable on their Parkinsonian medications
* Patients with another cause for autonomic neuropathy

Primary outcomes:
measure: Efficacy of conservative treatment, domperidone, and fludrocortisone for patient's subjective symptoms of orthostatic hypotension, and on objective autonomic testing
Secondary outcomes:
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
Study officials:
affiliation: Movement Disorders Fellow
name: Kerrie Schoffer, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Veazie S, Peterson K, Ansari Y, Chung KA, Gibbons CH, Raj SR, Helfand M. Fludrocortisone for orthostatic hypotension. Cochrane Database Syst Rev. 2021 May 17;5(5):CD012868. doi: 10.1002/14651858.CD012868.pub2.
Clinical trial NCT03739697: Effect of Spontaneous Breathing on Atelectasis During Induction of General Anesthesia in Patients in Infants
Official title: Seoul National University Children's Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atelectasis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-11-14
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: spontaneous breathing on occurrence of atelectsis in infants

Detailed description: Keeping the spontaneous breathing during the anesthesia for 5 minutes and occurrence of atelectasis

Eligibility criteria: Inclusion Criteria:

* general anesthesia

Exclusion Criteria:

* heart or lung problems
* prematurity

Primary outcomes:
measure: occurrence of atelectasis
timeFrame: 5 minutes after administration of anesthetics
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hee-Soo Kim
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ji SH, Jang HS, Jang YE, Kim EH, Lee JH, Kim JT, Kim HS. Effect of spontaneous breathing on atelectasis during induction of general anaesthesia in infants: A prospective randomised controlled trial. Eur J Anaesthesiol. 2020 Dec;37(12):1150-1156. doi: 10.1097/EJA.0000000000001327.
Clinical trial NCT01585597: Reperfusion With Cooling in Cerebral Acute Ischemia
Official title: Phase 1 Study of Mild Induced Hypothermia After Endovascular Revascularization in Acute Ischemic Stroke of the Anterior Circulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Stroke, Acute
Keywords: Ischemic Stoke
Endovascular Reperfusion
Reperfusion Injury
Mild hypothermia
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2012-04-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether reducing a patients body temperature (mild hypothermia of 33 degrees Centigrade) will significantly reduce the risk of brain injury (notably reperfusion injury and hemorrhagic conversion) in patients that have suffered a significant interruption of blood flow to an area of brain (occlusion of large proximal cerebral artery) and have undergone successful removal of that interruption (revascularization).


Eligibility criteria: Inclusion Criteria:

* Age 18-85 years old
* Symptoms consistent with an ischemic stroke with a large vessel occlusion (MCA, ICA-terminus) as determined by vascular imaging
* ASPECTS score of 5-7 on non-contrast CT of the brain
* Ability to undergo endovascular reperfusion therapy
* Must have no contraindications to general anesthesia
* A pre-treatment modified Rankin Score of 0 or 1
* Arterial puncture performed under 8 hours from symptom onset or last seen normal
* Immediate post reperfusion CT scan shows no hemorrhage

Exclusion Criteria:

* Bleeding diathesis with a platelet count \< 50,000 or INR \> 1.5
* Involved in another clinical trial
* History of dementia
* End stage renal disease on hemodialysis
* History of ventricular dysrhythmias
* Life threatening medical condition precluding survival under 6 months
* Presence of an IVC filter
* Contrast dye allergy with history of anaphylaxis

Primary outcomes:
measure: Number of Participants With Reperfusion Injury \ Hemorrhagic Transformation
timeFrame: 24 Hours
Secondary outcomes:
measure: Modified Rankin Scale 0-2
timeFrame: 90 days post hospitalization
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Marcus Stroke and Neuroscience Center at Grady Memorial Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Rishi Gupta, MD
role: STUDY_DIRECTOR
References:
citation: Horn CM, Sun CH, Nogueira RG, Patel VN, Krishnan A, Glenn BA, Belagaje SR, Thomas TT, Anderson AM, Frankel MR, Schindler KM, Gupta R. Endovascular Reperfusion and Cooling in Cerebral Acute Ischemia (ReCCLAIM I). J Neurointerv Surg. 2014 Mar;6(2):91-5. doi: 10.1136/neurintsurg-2013-010656. Epub 2013 Mar 6.
Clinical trial NCT00540397: TCM Etiological Study on the Theory of XuSunShengJi in Liver Cirrhosis
Official title: Traditional Chinese Medicine Etiological Study on the Theory of XuSunShengJi in Liver Cirrhosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Cirrhosis
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2007-10-08
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: To Elucidate and Confirm the Theory of XuSunShengJi in the Traditional Chinese Medicine Etiological Pathogenesis of Liver Cirrhosis.


Eligibility criteria: Inclusion Criteria:

* With 6 month of chronic liver disease history, and positive serum HBsAg

Exclusion Criteria:

* Other chronic hepatitis and liver cirrhosis of non-hepatitis B

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
state: Shanghai
Study officials:
affiliation: Shanghai University of Traditional Chinese Medicine
name: Ping Liu, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00442897: Vytorin (10/20 Or 10/40) Compared to Atorvastatin (10 mg or 20 mg) in Patients With Coronary Artery Disease (0653A-126)(COMPLETED)
Official title: Evaluate The Lipid-Lowering Efficacy and Safety of Vytorin in Comparison With Atorvastatin in Hypercholesterolaemic Patients With Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypercholesterolemia
Keywords: Hypercholesterolaemia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2007-03-05
Enrollment: 229
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the proportion of hyperlipaemic persons with known coronary heart disease achieving ldl-c goal as defined by the national cholesterol education program (NCEP) adult treatment panel (ATP) III guidelines


Eligibility criteria: Inclusion Criteria:

* Patients who are naïve to lowering lipid agent
* Patients who are treated with lowering lipid agents and had a wash-out period for 4 weeks.

Exclusion Criteria:

* Impaired kidney function
* Increased liver enzyme levels
* Pregnant women
* Hypersensitivity to ezetimibe and other statin agents

Primary outcomes:
measure: Number of Participants Reaching the LDL-C (Low Density Lipoprotein-Cholesterol) Goal (< 100 mg/dl) After 6 Weeks of Treatment
timeFrame: After 6 weeks of treatment
Secondary outcomes:
measure: Number of Participants Reaching the LDL-C Goal (< 100 mg/dl) After 12 Weeks of Treatment
timeFrame: After 12 weeks of the treatment
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01813097: Combination Iodine 125 Seed Implants and LHRH Agonists for Locally Advanced (Stage T3) Prostate Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: To detective the effect of the treatment of combination iodine 125 seed implants and LHRH agonists for the patients with locally advanced prostate cancer.
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2013-03-18
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subject number: \<\<60\>\>

Brief summary: Patients with prostate cancer should have the following examination including biopsy, serum PSA volume, prostate CT scan or MRI, bone scan, abdomen ultrasound, chest X ray, blood biochemistry, blood rout, ECG and testosterone.

Two groups:

First group:30 cases should be treated with iodine 125 seed implants 0.5 mc transperineal prostate implant +Zoladex 3.6mg im 1/28d (LHRH agonist, 3.6mg subcutaneous injection 1/4weeks).

Second group: 30 cases should be treated with Zoladex 3.6mg im 1/28d (LHRH agonist, 3.6mg subcutaneous injection 1/4weeks).

PFS and PSA level will be the primary variables.


Eligibility criteria: Inclusion Criteria:

1. Provision of written informed consent
2. T2c-T3b N0 M0 (biopsy、 bone scan、 CT、 MRI)
3. No Metastasis (bone scan、 CT、 MRI)
4. PSA level\>10ng/ml
5. Histological or cytological confirmation of prostate cancer
6. Able to understand and comply with the requirements of the study

Exclusion Criteria:

1. Having been treated with external radiation therapy or chemistry therapy.
2. Clinical relevant disease and/or abnormalities (past or present), eg, significant cardiovascular, renal or liver disease, malignancy, gastro-intestinal disorders, or other conditions which could affect the absorption/elimination of drugs.
3. Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 2 times the upper limit of normal (ULN) at screening findings that make it undesirable for the patient to participate in the study in the opinion of the investigator(s)
4. In the opinion of the investigator(s), any evidence of severe or uncontrolled systemic disease (eg, currently unstable or unresolved respiratory, cardiac, hepatic, or renal disease).
5. Contra-indications (eg, known or suspected allergy) to GnRH antagonists or excipients(non-active ingredients of investigational product).
6. Treatment with a non-approved or investigational drug within 30 days before study entry.
7. Bibulosity or drug abuse.

Primary outcomes:
measure: To detective the effect of the treatment of combination iodine 125 seed implants and LHRH agonists for the patients with locally advanced prostate cancer.
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03200197: Effectiveness of Menthol Chewing Gum in the Management of Thirst
Official title: Effectiveness of Menthol Chewing Gum in the Management of Preoperative Thirst: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thirst
Keywords: Chewing gum
Artificial saliva
Saliva
Mastication
Salivary glands
Xerostomia
Lead sponsor: Universidade Estadual de Londrina
Sponsor class: OTHER
First posted: 2017-06-27
Enrollment: 102
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study was to compare the effectiveness of menthol chewing gum compared to maintained fasting (usual care) in reducing the intensity of the surgical patient's thirst during the preoperative period. The hypothesis of the study was that the use of menthol chewing gum in surgical patients in the preoperative period would be more effective than the maintenance of fasting with regard to the decrease in thirst and its discomforts.

Detailed description: There is evidence that chewing gum is effective in relieving thirst in the surgical patient in the preoperative period as it stimulates the salivary glands by means of mechano and chemoreceptors, increasing the salivary pH and flow, lubricating the oral cavity, acting in this way on peripheral thirst, which is triggered by dehydration of the oral mucosa. Furthermore, menthol gum stimulates the cold receptors, known as TRPM8, which are responsible for deactivating centers of thirst. Thus, the risk of bronchoaspiration due to gastric fullness is avoided and the discomfort of a dry mouth is reduced.Preliminary evidence indicates that the chewing gum strategy assists in the relief of a dry mouth and thirst in patients undergoing dialysis and head and neck radiotherapy. However, there is no scientific evidence of controlled studies with results that can be generalized regarding the use of chewing gum to reduce thirst and its discomforts in surgical patients in the preoperative period when they remain in a fasted state.

Eligibility criteria: Inclusion Criteria:

* Elective Surgeries;
* Aged between 12 and 65 years;
* Did not receive preanesthetic medication;
* Oriented in time and space;
* Present dentition (natural or artificial);
* Fasting for a minimum of three hours;
* Available for collection at least 3 hours prior to the scheduled surgical procedure;
* Verbalize thirst spontaneously or when questioned with an intensity greater than or equal to three on the Verbal Numerical Scale (VNS);

Exclusion Criteria:

* Allergy to menthol;
* Chewing restriction;
* Swallowing restriction;
* Patients who presented nausea, vomiting, or pain;
* Patients with chronic xerostomia;
* Chronic renal patients;

Primary outcomes:
measure: intensity of thirst
timeFrame: 10 minutes
Secondary outcomes:
measure: discomfort of thirst
timeFrame: 10 minutes
Other outcomes:
Locations:
Study officials:
affiliation: State University of Londrina
name: Ligia Fahl Fonseca
role: STUDY_DIRECTOR
References: