louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01073111: Assessment of Stent Strut Coverage and Endothelial Function After Drug-Eluting Stents
Official title: Assessment of Neointimal Stent Strut Coverage and Endothelial Function After Second Generation Drug-Eluting Stent Systems
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Coronary Artery Disease
Atherosclerosis
Lead sponsor: Hyogo Medical University
Sponsor class: OTHER
First posted: 2010-02-23
Enrollment: 0
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare coronary endothelium function in patients with a zotarolimus-eluting versus a sirolimus-eluting or a everolimus-eluting stents with optical coherence tomography, vasoconstriction in response to acetylcholine, and coronary biomarker level.


Eligibility criteria: Inclusion Criteria:

* Significant coronary de novo lesion (\> 70% by quantitative angiographic analysis)
* Patients with stable or acute coronary syndrome considered for coronary revascularization
* Reference vessel diameter of 2.5 to 3.5 mm by operator assessment

Exclusion Criteria:

* Contraindication to anti-platelet agents
* Ostial lesion within 5 mm from ostium
* Different DES in other vessel simultaneously
* Creatinine level 2.5 mg/dL
* Left main stenosis more than 50%.
* vein graft lesion
* Triple vessel disease with stenosis more than 50% in 3 epicardial coronary arteries
* Life expectancy 1 year
* Reference vessel \< 2.5 mm or \> 4.0 mm diameter by visual
* Long lesion that require more than three stents

Primary outcomes:
measure: To compare coronary endothelial function after primary angioplasty.
timeFrame: 6 months and 12 months
measure: To compare the presence of neointimal stent strut coverage via optical coherence tomography.
timeFrame: 6 months and 12 months
measure: To compare the serum biomarker levels measured in coronary artery blood.
timeFrame: 6 months and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nishinomiya
country: Japan
facility: Hyogo College of Medicine
Study officials:
References:
Clinical trial NCT04710511: Association Between Child's Psychological Resilience and Practicing Oral Habits
Official title: Association Between Child's Psychological Resilience and Practicing Oral Habits: Cross Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Habits
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 216
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Medically free children aged from 5 years to 7 years

Brief summary: The aim of the present study is to determine the effect of psychological resilience on practicing oral habits among a group of 5- to 7-year-old children.

Detailed description: Psychological pressure has been thought to be a predisposing factor that might result in deleterious oral habits practicing. Shahraki et al. stated that increased stress levels are associated with oral habits as thumb sucking and nail biting. Leme et al. concluded that children and adolescents with DOH presented more symptoms of depression than their counterparts. Moreover, they were more likely to report symptoms of anxiety.

Ability to cope (or resilience) includes a person's sense of agency and their ability to think and behave, to make positive decisions, and to apply skills and knowledge to life challenges. The term resilience has come to mean an individual's ability to overcome adversity and continue his or her normal development.

The association between psychological resilience and practicing oral habits in children remains unclear, this study aims to reveal that association, if present.

Eligibility criteria: Inclusion Criteria:

* Medically free children

Exclusion Criteria:

-

Primary outcomes:
measure: Psychological resilience
timeFrame: Base line, subject will asked to fill the questionnaire for once
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: This study is carried out online, through social media
Study officials:
affiliation: Fuculty of Dentistry, Ahram Canadian University
name: Mennat Allah A.Elkareem, B.D.S
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leme M, Barbosa T, Castelo P, Gaviao MB. Associations between psychological factors and the presence of deleterious oral habits in children and adolescents. J Clin Pediatr Dent. 2014 Summer;38(4):313-7. doi: 10.17796/jcpd.38.4.c48238322205466w.
citation: Measure, Y. R. (2011). Child and Youth Resilience Measure.
citation: Nicole, B., Velida, D.-S., & Michelle, R. (2018). Guidance on Measuring Children ' s Psychosocial Well - being. https://www.crs.org/sites/default/files/tools-research/meal4kids_well-being_guidance_aug_10_lo_res.pdf
citation: Resilience Research Centre. (2018). Child and Youth Resilience Measure (CYRM-R) & Adult Resilience Measure (ARM-R) Manual 2.2. CYRM and ARM User Manual. http://www.resilienceresearch.org/
citation: hahraki, N., Yassaei, S., & Moghadam, M. G. (2012). Abnormal oral habits: A review. Journal of Dentistry and Oral Hygiene, 4(May), 12-15. https://doi.org/10.5897/JDOH12.001
Clinical trial NCT01026311: Coenzyme Q10 in Older Athletes Treated With Statin Medications
Official title: A Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Efficacy of Coenzyme Q10 in Improving Mitochondrial Function in Older Athletes Treated With Statin Medications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Muscle Weakness
Myalgia
Side Effects of Statins
Keywords: Coenzyme q10
statins
myalgias
anaerobic threshold
athletic performance
Lead sponsor: Ochsner Health System
Sponsor class: OTHER
First posted: 2009-12-04
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of coenzyme Q10 administration in improving mitochondrial function as measured by anaerobic threshold in older athletes on a stable dose of statin medication.


Eligibility criteria: Inclusion Criteria:

* Patients ≥ 50 years of age, male or female.
* Patients on a stable dose of statin medication for at least 3 months prior to enrollment in the study
* Self-Described Athletes with any of the following characteristics:

  * Participation in a competitive athletic event within the past year or currently training for a competitive athletic event within the 6 months following enrollment
  * Regular exercise activity of at least 45 minutes duration 5 times per week

Exclusion Criteria:

* Use of coenzyme Q10 during the preceding two months.
* CPK level at baseline greater than two times the upper limits of normal
* LDL level at baseline greater than 160 for those without a cardiovascular risk or cardiovascular risk equivalent
* LDL level at baseline greater than 130 for those with a cardiovascular risk or cardiovascular risk equivalent

Primary outcomes:
measure: The primary objective of this study is to test if oral coenzyme Q10 is superior to placebo in improving oxygen consumption by mitochondria as measured by cardiopulmonary fitness testing for anaerobic threshold in this population
timeFrame: The study will consist of an initial six week treatment period followed by a six week washout period. Subjects will then crossover to the alternative treatment for a second six week study period.
Secondary outcomes:
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Ochsner
state: Louisiana
Study officials:
affiliation: Ochsner
name: Richard Deichmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04429711: Ivermectin vs. Placebo for the Treatment of Patients With Mild to Moderate COVID-19
Official title: Ivermectin vs. Placebo for the Treatment of Patients With Mild to Moderate COVID-19 to Prevent Progression to Severe Infection and to Decrease Viral Shedding - A Double Blind , Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2020-06-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind randomized
Primary purpose: TREATMENT

Brief summary: Ivermectin which is an FDA-approved broad spectrum anti-parasitic agent, has also anti-viral activity. In vitro study have shown its activity against SARS-CoV-2, however its clinical effect on patients with COVID-19 never been tested.

In this RCT we would like to evaluate the effect of Ivermectin on reduction of viral shedding among mild to moderate COVID-19 patients, and in shortening the symptom resolution time.


Eligibility criteria: Inclusion Criteria:

Participants eligible for inclusion will include non-pregnant adult (\>18 years old) with molecular confirmation of COVID-19. \[Participants will be eligible in a period of no longer than 72 hours after exposure\].

Exclusion Criteria:

* Severe infection ( defined as need for invasive or non-invasive ventilator support, ECMO or shock requiring vasopressor support).
* Weight below 40Kg or above 100Kg
* Unable to take oral medication
* Known allergy to the drugs
* Pregnancy or breast feeding
* Participating in another RCT for treatment of COVID-19.

Primary outcomes:
measure: Viral clearance at day 6
timeFrame: Outcome will be determined till 6 days post intervention
measure: Viral shedding duration
timeFrame: Outcome will be determined till 14 days post intervention
measure: Symptoms clearance time
timeFrame: Outcome will be determined till 14 days post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat-Gan
country: Israel
facility: Sheba Medical Center
Study officials:
References:
Clinical trial NCT06451211: Neoadjuvant Immunotherapy Plus Chemotherapy in Borrmann Type 4 and Large Type 3 Gastric Cancer
Official title: Phase II Study of Neoadjuvant Immunotherapy Plus Chemotherapy in Borrmann Type 4 and Large Type 3 Gastric Cancer (Neo-ICEBOAT Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Stomach Neoplasms
Gastric Cancer
Linitis Plastica of Stomach
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-06-11
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to test the efficacy and safety of immunotherapy plus chemotherapy on people with a relatively rare type of gastric cancer. Participants will take the anti-PD-1 inhibitor (Tislelizumab) and platinum-based chemotherapy (oxaliplatin + capecitabine or oxaliplatin + S-1) in a 3-week cycle, followed by a radical operation after 6 cycles.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed gastric adenocarcinoma,cT1-2N+M0 or cT3-4NanyM0;
* Males or females, aged 18-70 years;
* Gastroscopy and abdominal computed tomography (CT) scan-confirmed typical scirrhous gastric cancer (borrmann type 4) or large type 3 (over 8 cm);
* No peritoneal metastasis confirmed by laparoscopic exploration and with cytological examination of peritoneal washing of the Douglas pouch;
* ECOG performance status 0 or 1;
* Sufficient organ function:

  * white blood cell count \> 4\*10\^9/L, neutrophil cell count \> 1.5\*10\^9/L, hemoglobin \> 90 g/L, platelet count \> 100\*10\^9 /L
  * Serum bilirubin ≤ 1.5×upper limit of normal (ULN), AST, ALT ≤ 2.5×ULN
  * Creatinine ≤ 1.5 ×ULN or serum clearance \> 60 ml/min
  * INR and aPTT ≤ 1.5 × ULN, only for subjects not receiving anticoagulant therapy;Subjects undergoing coagulation therapy should use a stable dose
* No prior anti-tumor therapy;
* Have signed informed consent before the beginning of treatment.

Exclusion Criteria:

* History of another malignancy within the last five years;
* Previous cytotoxic chemotherapy, radiotherapy or immunotherapy
* Unable to take drugs orally
* Allergic to to any drug of the study regimen;
* Women who are pregnant or breastfeeding or may be pregnant

Primary outcomes:
measure: MPR
timeFrame: up to 2 years
Secondary outcomes:
measure: Adverse Events
timeFrame: up to 2 years
measure: Incidence of surgical complications
timeFrame: up to 2 years
measure: Rate of R0 resection
timeFrame: up to 2 years
measure: OS
timeFrame: up to 5 years
measure: DFS
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Haibo Qiu, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03413111: Modified Double Wire Technique to Facilitate the Successful Cannulation
Official title: Modified Double Wire Technique to Facilitate the Successful Cannulation: Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Biliary Cannulation
Endoscopic Retrograde Cholangiopancreatography
Keywords: ERCP
double guidewire technique
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2018-01-29
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Selective cannulation is considered the most challenging step for most of Endoscopic retrograde cholangiopancreatography (ERCP). Wire-guided cannulation is the standard technique for initial cannulation. When meeting difficulty, double wire technique (DWT) is widely used. With one guidewire occupying pancreatic duct (PD), the following cannulation of common bile duct (CBD) with a sphincterotome preloaded with another guidewire often becomes feasible. However, because of the small opening of the papilla, sometimes it is technically challenging for the following cannulation of CBD with the sphincterotome and PD guidewire in the same working channel. We hypothesized that a tiny cut of the opening of papilla, without the injury of pancreatic sphincter, may facilitate the success of DWT and shorten the overall cannulation time.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18-90 with native papilla;
* CBD as the targeted duct;
* Inadvertent PD cannulation more than twice;
* Selective biliary cannulation was not possible within 10 minutes or 5 attempts.

Exclusion Criteria:

* Contraindications of ERCP;
* Major or minor PD as the targeted duct;
* NK or transpancreatic precut before enrollment ;
* Surgically altered GI anatomy;
* Papillary carcinoma or stone impaction within papilla or fistula in papilla;
* Prior endoscopic sphincterotomy;
* Complete pancreas divisum;
* failure of pancreatic duct cannulation;
* Pregnant or breastfeeding women;
* Unwilling or inability to provide consent.

Primary outcomes:
measure: Success rate of double wire technique
timeFrame: 3 hours
Secondary outcomes:
measure: cannulation time of double wire technique
timeFrame: 3 hours
measure: Number of attempts for the successful CBD cannulation
timeFrame: 3 hours
measure: Overall cannulation success rate
timeFrame: 3 hours
measure: complication rates
timeFrame: 48 hours
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Endoscopic center, Xijing Hospital of Digestive Diseases
state: Shaanxi
Study officials:
References:
Clinical trial NCT03831711: 68-Ga-RM2 PET/MRI in Imaging Patients With Estrogen Receptor-Positive Breast Cancer
Official title: A Pilot Study of 68-Ga-RM2 PET/MRI in the Evaluation of Patients With Estrogen Receptor-Positive Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Breast Carcinoma
Estrogen Receptor Positive
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: General Electric
First posted: 2019-02-06
Enrollment: 5
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: This trial studies how well 68-Ga RM2 works with PET/MRI in imaging patients with estrogen receptor-positive breast cancer. 68-Ga-RM2 is an agent used in diagnostic imaging.

Detailed description: PRIMARY OBJECTIVES:

I. To evaluate the feasibility of 68-Ga RM2 PET/MRI for identification of estrogen receptor positive primary breast cancer and metastases

OUTLINE:

Patients receive 68-Ga-RM2 intravenously (IV) and after 45 minutes undergo PET/MRI over 30-60 minutes.

After completion of study, patients are followed up at 24-72 hours, and then for 12 months.

Eligibility criteria: Inclusion Criteria:

* ER+ breast cancer at initial diagnosis prior to surgery or at recurrence (at least one ER+ lesion based on results of biopsy).
* Able to provide written consent
* Karnofsky performance status of ≥ 50 (or Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) equivalent)

Exclusion Criteria:

* Less than 18 years-old at the time of radiotracer administration
* Inability to lie still for the entire imaging time
* Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
* Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance
* Renal function impairment preventing administration of MRI contrast
* Metallic implants (contraindicated for MRI)

Primary outcomes:
measure: Detection of ER Positive Breast Cancer and Metastases on 68-Ga RM2 PET/MRI
timeFrame: up to 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Cancer Institute Palo Alto
state: California
Study officials:
affiliation: Stanford Cancer Institute Palo Alto
name: Andrei Iagaru
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02104011: Treatment of Renal Angiomyolipomas in Tuberous Sclerosis by Beta-blockers
Official title: Treatment of Renal Angiomyolipomas in Tuberous Sclerosis by Beta-blockers: Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Renal Angiomyolipomas
Tuberous Sclerosis
Keywords: Angiomyolipomas in tuberous sclerosis
Beta-blockers
Anti-angiogenic therapies
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2014-04-04
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Treatment of angiomyolipomas is based on invasive techniques such as surgery or embolization. Development of anti-angiogenic therapies is a major and growing field of research in hypervascularized tumors. Angiomyolipomas have been shown to regress after prolonged treatment with mTOR inhibitors (Sirolimus), but with a large proportion of secondary effects. We showed recently that beta-blockers were able to induce regression of infantile hemagiomas. Consequently, we looked for and found, histologically, in a few cases of angiomyolipomas the presence of beta2 receptors.

The aim of the study is to estimate if beta-blockers could induce regression or stabilization of renal angiomyolipomas in tuberous sclerosis in a pilot study.


Eligibility criteria: Inclusion Criteria:

* Tuberous sclerosis patients with one or several angiomyolipomas of a size of at least 4 cms.

Exclusion Criteria:

* Patients whom CT or MR scan shows one or several intra-lesional aneurisms requiring a preventive embolization.
* Patients with a retroperitoneal hemorragic complication requiring a preventive embolization.
* Patients whom biopsy will show an adenocarcinoma, hypertension non controlled, renal failure and severe liver.
* Diabetic subjects insufficiently controlled.
* Beta-blockers contra-indication.
* Psychosis, severe mental disorder.
* Patient already treated with beta-blockers or mTOR inhibitors.
* Pregnant or nursing women.

Primary outcomes:
measure: Evolution of angiomyolipomas volume
timeFrame: 6 months and 1 year after inclusion
Secondary outcomes:
measure: Renal function evolution
timeFrame: 6 months and 1 year after inclusion
measure: Effect on the potential haemorraghic transformation
timeFrame: 6 months and 1 year after inclusion
measure: Improvement of the quality of life
timeFrame: 6 months and 1 year after inclusion.
measure: Effect on face angiofibromas
timeFrame: 6 months and 1 year after inclusion
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Nephrology department
Study officials:
affiliation: University Hospital, Bordeaux
name: Claire RIGOTHIER, Dr
role: PRINCIPAL_INVESTIGATOR
References: