louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05129774: Chemoradiotherapy Sequenced Radical Surgery for Colorectal Cancer With PALNM
Official title: Concurrent Chemoradiotherapy Sequenced Radical Surgery for Para-aortic Lymph Node Metastasis of Left-sided Colon and Rectal Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Colorectal Neoplasms Malignant
Lymph Node Excision
Chemoradiotherapy
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2021-11-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: In left-sided colon and rectal cancer, the occurrence of synchronous para-aortic lymph node metastasis is rare, with the incidence of being approximate 1-2%. Currently, there has been no standard treatment strategy for this situation. The present trial is designed to evaluate the safety and efficacy of para-aortic lymph node dissection for left-sided colon and rectal cancer with synchronous para-aortic lymph node metastasis


Eligibility criteria: Inclusion Criteria:

* age at enrollment is ≥ 18 and ≤ 75 years
* ECOG PS 0-1
* histologically confirmed left-sided colon and rectal carcinoma
* synchronous para-aortic lymph node metastases confirmed by PET-CT, and located below the level of renal veins and above the bifurcation of iliac artery
* patients potential to receive surgery and achieve no evidence of disease (NED)
* able to tolerate surgery
* providing written informed consent

Exclusion Criteria:

* local invasion or distant metastasis other than para-aoritc lymph nodes
* history of other malignant tumor
* coupled with severe systematic diseases (recent myocardial infarction, cardiomyopathy, or acute pulmonary infection)
* emergency surgery

Primary outcomes:
measure: 5-year OS
timeFrame: From date of recruitment until the date of death from any cause, assessed up to 5 years
Secondary outcomes:
measure: DFS
timeFrame: From date of recruitment until the date of disease recurrece, assessed up to 5 years
measure: LFFS
timeFrame: From date of recruitment until the date of para-aortic lymph node recurrence, assessed up to 3 years
measure: Postoperative complications
timeFrame: From date of surgery until the date of 30 days after surgery
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
References:
Clinical trial NCT00839774: Effect of Pulse Fractions on Indices on Cardiovascular Disease and Diabetes Risk Factors
Official title: Effect of Pulse Fractions on Indices of Lipid, Carbohydrate and Energy Metabolism as Well as Oxidative Status in Overweight, Hyperlipidemic Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cardiovascular Disease
Keywords: Peas
Cardiovascular
Diabetes
Insulin
Insulin resistance
Abdominal fat
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Pulse Canada
First posted: 2009-02-10
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if whole and fractionated yellow pea flour, administered at USDA recommended dosages (50 g/day), improve risk factors associated with cardiovascular disease and diabetes.


Eligibility criteria: Inclusion Criteria:

* BMI between 25 and 40 kg/m2
* Hypercholesterolemic

Exclusion Criteria:

* Smoking
* Use of prescription and natural lipid lowering therapies
* Myocardial infarction
* Coronary artery bypass
* Angina
* Congestive heart failure,
* Inflammatory bowel disease
* Pancreatitis
* Renal disease
* Diabetes
* Chronic alcohol usage (\> 2 drinks/day).
* Cancer
* Eating disorders
* Expending \> 4000 kcal/week through exercise

Primary outcomes:
measure: Lipid levels
timeFrame: Day 1 & 2 and Day 28 & 29 of each treatment phase
measure: Postprandial glucose response
timeFrame: During week 1 and week 4 of each treatment phase
measure: Fasting Insulin
timeFrame: Day 1 & 2 and Day 28 & 29 of each treatment phase
measure: Insulin homeostasis modeling assessment
timeFrame: Day 1 & 2 and Day 28 & 29 of each treatment phase
measure: Energy expenditure
timeFrame: During week 1 and week 4 of each treatment phase
measure: body composition
timeFrame: Day 1 and Day 29 of each treatment phase
measure: Antioxidant status
timeFrame: Day 1 & 2 and Day 28 & 29 of each treatment phase
measure: Postprandial substrate utilization
measure: Postprandial dietary fatty acid oxidation
Secondary outcomes:
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba - Richardson Centre for Functional Foods and Nutraceuticals
state: Manitoba
Study officials:
affiliation: University of Manitoba - Richardson Centre for Functional Foods and Nutraceuticals
name: Peter J.H. Jones, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06329674: Efficacy and Safety of AJU-A51 in Type 2 Diabetes Mellitus Patients
Official title: Evaluate the Efficacy and Safety of the Combination of A51R3 and AJU-A51 Compared With the Combination of A51R3 and A51R2 in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type2 Diabetes
Lead sponsor: AJU Pharm Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-03-26
Enrollment: 235
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A multicenter, randomized, double-blind, parallel group, placebo-controlled, phase 3 study to evaluate the efficacy and safety of the combination of A51R3 and AJU-A51 compared with the combination of A51R3 and A51R2 in patients with Type 2 diabetes mellitus who have inadequate glycemic control with the combination of A51R3 and A51R2


Eligibility criteria: Inclusion Criteria:

* Those who voluntarily signed the informed consent to participate in this study.
* Adults aged 19-75 years.
* Those diagnosed with type 2 diabetes mellitus.
* 7% ≤ HbA1c ≤ 10.5%
* FPG ≤ 270 mg/dL
* BMI ≤ 40 kg/㎡
* Subjects able to understand the study, comply with study procedures, and attend all scheduled visits.

Exclusion Criteria:

* Those who suffered from acute or chronic metabolic acidosis, lactic acidosis and diabetic ketoacidosis.
* Those who had genetic disorders such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption.
* Those with heart failure (NYHA class II\~IV) or who had suffered from heart failure.
* Those with a history of malignant tumor within 5 years
* Those who have a clinically significant liver disease
* Those who have a clinically significant renal disease
* SBP \> 180 mmHg or DBP \> 110 mmHg
* Those who had allergic reaction to main ingredients or components of the investigational products.
* Patients planning to become pregnant or of childbearing potential, but not using any recognized contraceptive method
* Females who are pregnant or breastfeeding.
* AST or ALT ≥ LRN\*3
* TG ≥ 500 mg/dL

Primary outcomes:
measure: Changes in HbA1c
timeFrame: 24th week
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
Clinical trial NCT01179074: Role of Radiotherapy Following Oesophageal Stenting in Cancer
Official title: Palliative Stenting With or Without Radiotherapy for Inoperable Oesophageal Carcinoma: a Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oesophageal Cancer
Keywords: palliation inoperable oesophageal cancer
Lead sponsor: All India Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2010-08-11
Enrollment: 84
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To assess the benefits of oesophageal stenting and external beam radiotherapy over oesophageal stenting alone in patients with inoperable oesophageal cancer

Detailed description: A majority of patients with oesophageal cancer present with inoperable disease and require rapid and long lasting palliation of dysphagia.

STUDY AIM: To compare dysphagia relief in patients treated with oesophageal stenting and external beam radiotherapy (EBRT), versus oesophageal stenting alone and to assess overall survival, treatment related complications, and quality of life in the two groups.

PATIENTS AND METHODS: Patients with inoperable oesophageal cancer with high grade dysphagia to be randomised to receive oesophageal stenting alone (Group I), versus a combination of stenting followed by EBRT (Group II). Dysphagia relief, treatment related complications, overall survival, and quality of life to be assessed in the two groups.

Eligibility criteria: Inclusion Criteria:

* Oesophageal cancer patients with locally advanced unresectable cancer (such as invasion of tracheo-bronchial tree, aorta, pulmonary vascular structures, etc),
* Metastatic disease, and co-morbid conditions precluding major surgical procedure (such as severe cardiopulmonary, hepatic and renal diseases) with grade 3 and 4 dysphagia, were included in the trial.

Exclusion Criteria:

* Patients with carcinoma of the cervical oesophagus and those who had already received prior radiotherapy, chemotherapy, or any other modality of treatment were excluded

Primary outcomes:
measure: Relief of dysphagia
timeFrame: 1 week after intervention
measure: Relief of dysphagia
timeFrame: 3 months following intervention
measure: Relief of dysphagia
timeFrame: 5 months after intervention
Secondary outcomes:
measure: Survival
timeFrame: From the date of diagnosis till death
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Departments of Gastrointestinal surgery, Gastroenterology, Radiation Oncology, All India Institute of Medical Sciences
state: Delhi
Study officials:
affiliation: Head, Dept. G.I Surgery, All India Institute of Medical Sciences, New Delhi
name: Tushar K Chattopadhyay, MS
role: STUDY_DIRECTOR
References:
citation: Schmid EU, Alberts AS, Greeff F, Terblanche AP, Schoeman L, Burger W, Shiels RA, Friediger D, Van der Hoven A, Falkson G. The value of radiotherapy or chemotherapy after intubation for advanced esophageal carcinoma--a prospective randomized trial. Radiother Oncol. 1993 Jul;28(1):27-30. doi: 10.1016/0167-8140(93)90181-7.
Clinical trial NCT00217074: Acupuncture and Hot Flashes
Official title: Acupuncture for Hot Flashes: A Randomized Sham Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hot Flashes
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 103
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Methods: 103 participants, after being randomized to medical versus sham acupuncture received bi-weekly treatments for 5 weeks, after a baseline assessment week. They were then followed for an additional 7 weeks. Participants completed daily hot flash questionnaires, which formed the basis for analysis.


Eligibility criteria: Participants eligible for this study were females aged 45 to 59 with a reported average of ¡Ý 5 hot flashes a day

Primary outcomes:
measure: Hot Flash Score
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
References:
Clinical trial NCT02674074: Evaluation of Corneal Temperature by Infrared Thermography in Glaucoma Patients
Official title: Evaluation of Corneal Temperature by Infrared Thermography in Glaucoma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2016-02-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Measurement of corneal temperature gives indirect information about the ocular blood flow. For this reason corneal temperature can be used as a surrogate to quantify ocular blood flow. It can be measured by means of infrared thermography. This test, however, is not used in an everyday clinical routine so far. In this study is investigated if ocular blood flow disturbances in glaucoma patients can be diagnosed by means of infrared thermography.

Corneal temperature are measured in normal tension glaucoma patients and healthy controls before and after cold provocation test. In the group of patients and the group of controls, subjects with and without a primary vascular dysregulation (PVD) are included. This will allow to analyze and compare the influence of cold provocation on corneal temperature (and indirectly ocular blood flow) in these study Groups.


Eligibility criteria: Inclusion Criteria for Patients:

* Glaucoma
* Age 18-65

Exclusion Criteria for patients:

* No Glaucoma
* Alcohol consumption
* Smoking

Inclusion Criteria for Control:

* No Glaucoma
* Age 18-65

Exclusion Criteria for control:

* Alcohol consumption
* Smoking

Primary outcomes:
measure: Corneal temperature measurement by infrared thermography
timeFrame: 2 measurements with interval of 5 minutes starting at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Ophthalmology, University Hospital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Josef Flammer, Prof. MD
role: STUDY_CHAIR
References:
Clinical trial NCT05955274: Mobile Behavioral Parent Training for Childhood ADHD: Pilot Trial
Official title: Personalizing Behavioral Parent Training: Improving Reach and Outcomes for Families of Children With ADHD
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: Florida International University
Sponsor class: OTHER
First posted: 2023-07-21
Enrollment: 50
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned to one of two groups
Primary purpose: TREATMENT

Brief summary: The goal of the study is to develop and pilot a personalized behavioral parent training intervention for caregivers of children with attention deficit hyperactivity disorder. The behavioral intervention will teach positive parenting through videos and quizzes that caregivers can access through a smartphone application. The program also gives parents and caregivers in-the-moment feedback their use of parenting strategies.

The main questions to answer are:

Is parenting feedback provided by a smartphone application acceptable to caregivers? Is the phone application usable and acceptable to parents and caregivers of children with attention deficit hyperactivity disorder?

In the pilot trial, participants (parents/caregivers) will be randomly assigned to either (1) use the positive parenting intervention phone application (mobile Behavioral Parent Training: mBPT) or (2) use mBPT and receive brief, personalized phone prompts throughout their participation that target parenting behavior and intervention engagement.


Eligibility criteria: Inclusion Criteria:

* currently meets Diagnostic Statistical Manual 5 diagnostic criteria for ADHD
* ages 7 -12
* has at least one parent or primary caregiver who is willing to participate and is able to access the intervention at home via smartphone.

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Intervention Engagement
timeFrame: Through study completion, average of 10 weeks
measure: Receipt of Prompts
timeFrame: Through study completion, average of 10 weeks
Secondary outcomes:
measure: Passive Audio Data- Positive Parenting
timeFrame: During the last 1 week of study completion
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Center for Children and Families of Western New York
state: New York
Study officials:
References:
Clinical trial NCT06544174: Long-term Clinical Follow-up After PCI for CTO
Official title: Long-term Clinical Follow-up After PCI for CTO
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Total Occlusion
Keywords: CTO
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 448
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: All patients who underwent an attempt of percutaneous recanalization of a CTO at Montpellier University Hospital between January 2015 and December 2022. All patients had symptoms (angina or dyspnea) and/or reversible myocardial ischemia in the territory of the occluded artery and myocardial viability

Brief summary: The research aimed to evaluate the impact of a successful Percutaneous coronary intervention of chronic total occlusions (CTO-PCI) on long-term MACE (Major Cardiovascular Events), symptoms, survival, Left Ventricular Ejection Fraction (LVEF) and myocardial ischemia up-to-8-years follow-up.

Detailed description: With this observational and prospective study, this research aimed to evaluate the impact of a successful CTO-PCI on long-term MACE (Major Cardiovascular Events), symptoms, survival, LVEF and myocardial ischemia up-to-8-years follow-up.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* who underwent at least one CTO procedure between 2025 and 2022 in Montpellier University Hospital
* symptomatic of reversible myocardial ischemia
* proof of myocardial viability

Exclusion Criteria:

* refusal of the patient to participate to the study

Primary outcomes:
measure: Major cardiovascular events (MACE)
timeFrame: Up to 8 years
Secondary outcomes:
measure: Non combined MACE components
timeFrame: Up to 8 years
measure: In-hospital events
timeFrame: Up to one week
measure: Restenosis
timeFrame: Up to 8 years
measure: Ischemic burden
timeFrame: Up to 8 years
measure: Stent thrombosis
timeFrame: Within 30 days after the procedure
measure: LVEF
timeFrame: Up to 8 years
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital, Montpellier
name: Florence Leclercq, PU-PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05596474: Effect of Beet-root Juice and PBM Treatments on Muscle Fatigue
Official title: Application of Beet-root Juice Supplementation and Photobiomodulation Treatment on Forearm Muscle Fatigue in Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Health Care Utilization
Healthy Aging
Keywords: Red light therapy
Forearm muscle endurance
Beet-root juice
Electromyography
Lead sponsor: Wake Forest University
Sponsor class: OTHER
First posted: 2022-10-27
Enrollment: 10
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this randomized counterbalanced repeated measures study is to test beet-root juice supplementation and red light therapy augment forearm muscle endurance in apparently healthy older adults over 65 years of age. The main questions seek to answer the following question:

Does beet-root juice supplementation improve forearm muscle endurance compared to a placebo supplement?

Does red light therapy improve forearm muscle endurance compared to a sham light exposure?

Does beet-root juice supplementation in combination with red light therapy improve forearm muscle endurance compared to a placebo-sham light control?


Eligibility criteria: Inclusion Criteria:

* Self-reports performing at least 30 minutes of light to moderate intensity physical activity 3 times per week for the last three months

Exclusion Criteria:

* Currently smoke
* Have smoked within the last 6 months
* Are taking taking supplements known to increase blood nitrate levels
* Have a known kidney disease
* Have a known liver disease
* Have a known thyroid condition
* Have a known gastritis condition
* Are taking medications that are known to cause complications with nitrate supplementation
* Have known or reported joint pain within the dominant hand

Primary outcomes:
measure: Total forearm work performed
timeFrame: During the forearm exercise fatigue protocol lasting up to 45 minutes
Secondary outcomes:
measure: Forearm endurance
timeFrame: During the forearm exercise fatigue protocol lasting up to 45 minutes
measure: Intermuscular coordination
timeFrame: During the forearm exercise fatigue protocol lasting up to 45 minutes
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Univesity
state: North Carolina
Study officials:
affiliation: Wake Forest University, Reynolda Campus
name: Andrew D Wells, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00454974: Pilot Study of Wearable Artificial Kidney
Official title: Preliminary Study to Assess the Safety and Efficacy of a Wearable Artificial Kidney Device for the Treatment of Patients With Endstage Renal Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Failure
Keywords: end stage renal failure
dialysis
wearable artificial kidney
Lead sponsor: Royal Free Hampstead NHS Trust
Sponsor class: OTHER
Collaborators: name: Xcorporeal
First posted: 2007-04-02
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a pilot study of a wearable type of kidney dialysis machine to treat patients with chronic kidney disease.

Detailed description: This is a pilot study to evaluate the clearances, tolerability and safety of a wearable artificial kidney device for treating patients with chronic kidney failure.

Eligibility criteria: Inclusion Criteria:

* End stage renal failure
* Regular haemodialysis
* Cardiovascular stability
* Stable vascular access

Exclusion Criteria:

* Allergy to heparin or ethylene oxide
* Recent cardiovascular or neurological event
* Unable to provide informed consent
* Age \< 18

Primary outcomes:
measure: urea, potassium, phosphate and B2M clearances
measure: safety - cardiovascular,no hemolysis, bleeding, infection
measure: no ammonia generation from sorbents, control of acid base balance
Secondary outcomes:
measure: fluid removal
measure: patient satisfaction questionnaire
measure: affect of treatment of cytokines
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: UCL Center for Nephrology
Study officials:
affiliation: Cedars Sinai, Los Angeles, USA
name: Victor Gurra, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gura V, Beizai M, Ezon C, Polaschegg HD. Continuous renal replacement therapy for end-stage renal disease. The wearable artificial kidney (WAK). Contrib Nephrol. 2005;149:325-333. doi: 10.1159/000085694.
citation: Gura V, Davenport A, Beizai M, Ezon C, Ronco C. Beta2-microglobulin and phosphate clearances using a wearable artificial kidney: a pilot study. Am J Kidney Dis. 2009 Jul;54(1):104-11. doi: 10.1053/j.ajkd.2009.02.006. Epub 2009 Apr 19.