louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03057925: Ultrasound-guided Percutaneous Microwave Ablation for Benign Thyroid Nodules
Official title: Ultrasound-guided Percutaneous Microwave Ablation for Benign Thyroid Nodules
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thyroid Nodule
Keywords: thyroid nodule
microwave ablation
Lead sponsor: First Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital of Wenzhou Medical University
First posted: 2017-02-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Percutaneous microwave ablation(MWA) was reported as an effective modality for the management of thyroid nodules(TNs). This study aims to validate MWA as a feasible approach for patients with TNs for whom surgery is contraindicated or refused. Two groups of subjects with TNs(one group to treat with MWA and the other group to receive regular ultrasonic follow-up without any treatment) will be evaluated in term of TN volume, ultrasonic image and clinical symptoms.


Eligibility criteria: Inclusion Criteria:

* age\>18 years
* benign thyroid nodules(TYP 2)
* solid or predominantly solid(colloid component\<30%)large (\>3.0ml) thyroid nodules
* refusal and/or inefficacy of surgery

Exclusion Criteria:

* pregnancy
* malignant or suspicious thyroid nodules

Primary outcomes:
measure: Change of the thyroid nodule volume assessed by ultrasonography after treatment vs simple clinical observation
timeFrame: From time to treatment until 12 months. Time point evaluations at 1,3,6,12 months
Secondary outcomes:
measure: Improved score on TN-related symptoms
timeFrame: From time to treatment until 12 months. Time point evaluations at 1,3,6,12 months
measure: Improved cosmetic grading score
timeFrame: From time to treatment until 12 months. Time point evaluations at 1,3,6,12 months
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: Thyroid Center of The First Affiliated Hospital of Wenzhou Medical University
name: Xiaojun Chen
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wu W, Gong X, Zhou Q, Chen X, Chen X. Ultrasound-Guided Percutaneous Microwave Ablation for Solid Benign Thyroid Nodules: Comparison of MWA versus Control Group. Int J Endocrinol. 2017;2017:9724090. doi: 10.1155/2017/9724090. Epub 2017 Nov 23.
Clinical trial NCT06694025: Post-marketing Surveillance Study for the Safety of Efluelda Tetra Pre-filled Syringe.
Official title: Post-marketing Surveillance Study for the Safety of Efluelda Tetra Pre-filled Syringe, a High-dose Quadrivalent Influenza Vaccine Administered to Adults 65 Years or Older in the Republic of Korea.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Immunization
Influenza (Healthy Volunteers)
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2024-11-19
Enrollment: 670
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Investigators will recruit participants after vaccination with Efluelda Tetra as per routine healthcare visits and according to approved local product labeling, at study centers (general hospitals or clinics located in Korea).

Brief summary: To investigate the incidence of adverse events (AEs) and adverse drug reactions (ADRs) occurred following administration of Efluelda Tetra in adults aged 65 years or older under routine clinical practice, as per approved indications.

The study duration of each participation will be approximately 28 to 35 days. In the event that Visit 2 is not made, the study duration would be extended to 36 to 42 days.


Eligibility criteria: Inclusion Criteria:

* Adults aged 65 years or older on the day of enrollment
* The informed consent form has been signed and dated
* Receipt of 1 dose of Efluelda Tetra on the day of enrollment according to the approved local product label

Exclusion Criteria:

* Previous history of enrollment in this study
* Participation at the time of study enrollment (or in the 4 weeks preceding the enrollment) or planned participation during the present study period in a clinical study investigating a vaccine, drug, medical device or medical procedure

Primary outcomes:
measure: Occurrence of solicited (pre-listed in the participant's diary card [DC] and case report form) injection site and systemic reactions
timeFrame: From baseline up to 7 days after vaccination
measure: Occurrence of unsolicited AEs and ADRs
timeFrame: From baseline up to Visit 2 (28-35 days) after vaccination
measure: Occurrence of unexpected AEs and ADRs
timeFrame: From baseline up to participant's last contact after vaccination (36-42 days)
measure: Occurrence of serious adverse events (SAEs) and serious adverse drug reactions (SADRs)
timeFrame: From baseline up to participant's last contact after vaccination (36-42 days)
measure: Occurrence of AE of special interest (AESI)
timeFrame: From baseline up to participant's last contact after vaccination (36-42 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
Clinical trial NCT05392725: Epidemiological Study on Malignancy Complicated With Renal Injury
Official title: Epidemiological Study on Malignancy Complicated With Renal Injury
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Kidney Injury
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 30000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients initially diagnosed with malignancy in Shanghai Renji Hospital from July 2017 to June 2021

Brief summary: The epidemiological study of tumor complicated with kidney disease can clarify the prevalence and risk factors of renal injury when malignant tumor is diagnosed, and understand the impact of malignant tumor complicated with renal injury on survival time. This study will bring enlightenment to clinicians, discover high-risk factors in time, and try to avoid renal damage factors in diagnosis and treatment. Early diagnosis and early treatment can partially terminate the progress of renal injury, avoid the suspension of treatment due to renal reasons, and avoid the occurrence of end-stage renal failure (ESRD).

Detailed description: 1. To determine the prevalence of malignant tumor complicated with renal injury and analyze the related risk factors.
2. To compare the survival time of malignant tumor with or without renal injury

Eligibility criteria: Inclusion Criteria:

* Malignancy confirmed by pathology.
* Between 18-80 years old, regardless of gender; Patients initially diagnosed with malignant tumors in our hospital from July 2017 to June 2021; Waiver of informed consent.

Exclusion Criteria:

* Patients with benign tumor diagnosed by pathology; The patient refused to participate; Patients judged by other researchers as unsuitable for inclusion in the study.

Primary outcomes:
measure: survival
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01188525: Pharmacokinetic Study to Characterize Individual Metabolic Profile
Official title: Pharmacokinetic of Ten Parent Drugs and Their Metabolits in Order to Characterise Individual Metabolic Profile
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: pharmacokinetics
enzymes
metabolism prediction
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
Collaborators: name: Nuclear Energy Commission (CEA)
First posted: 2010-08-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study aims to descibe the pharmacokinetics of 10 substrates of enzymes involved in drug metabolism and their metabolites, after administration singly and simultaenously at predefined doses in 10 health volunteers.

Detailed description: The aim of this study is to test the administration of combination of substrates and thereby to characterise simultaneously the main enzymes and transporters involved in drug metabolism. The doses of substrates administered will first assessed in terms of safety and their appropriateness for determination of pharmacokinetic parameters. Ten volunteers will be used, this number having been defined in view of the aims of this proof-of-concept pilot study,ie,safety and determination of pharmacokinetic parameters. The number was not the result of statistical calculation.

Eligibility criteria: Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* pregnancy

Primary outcomes:
measure: Pharmacokinetic parameters
timeFrame: one week
Secondary outcomes:
measure: Tolerance of the concomittant administration of the 10 drugs: 1/number of volunteers with grade 4 adverse events 2/ number of volunteers with any adverse event, (grade 1 to grade 4)
timeFrame: one week
measure: pharmacokinetic
timeFrame: one week
measure: Genotypes
timeFrame: one month
Other outcomes:
Locations:
city: Paris
country: France
facility: Center of clinical investigation
Study officials:
affiliation: Center of clinical investigation
name: DUVAL Xavier, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03333525: Does Protein and Fat Content of Meal Increase Glucose Concentrations
Official title: Does High-Protein High-Fat Meal Increase Postprandial Glucose Concentrations and Meal-Time Insulin Requirements in Patients With Type 1 Diabetes on Basal-Bolus Insulin Regimen: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: Fat-protein counting
Type 1 diabetes
Postprandial glucose level
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
Collaborators: name: Hacettepe University
First posted: 2017-11-07
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study investigated the effects of fat protein counting (CFP) in addition to carbohydrate (CARB) counting for calculating prandial insulin dosage on blood glucose profile in patients with type 1 diabetes (T1D) on basal-bolus insulin therapy.

Detailed description: In this single center, crossover, randomized, controlled study, control meal (SM: standard meal using carbohydrate counting method) and three test meals (HPM: high protein meal using carbohydrate counting method, HPFM-a: high protein-fat meal using carbohydrate counting method and HPFM-b: high protein-fat meal using carbohydrate and fat-protein counting method) were compared on postprandial early (0-120 minutes), late (120-240 minutes) and total (0-240 minutes) glucose response.

Eligibility criteria: Inclusion Criteria:

Subjects:

* had Type1 Diabetes for at least 1 years;
* use multiple dose (basal-bolus) insulin therapy;
* use fast-acting insulin analogs (lispro, glulisine, and aspart) and basal insulin analogs (detemir, glargine);
* daily inslin dose ≥0.5 IU/kg/day.

Exclusion Criteria:

Subjects:

* had any restrictive food intake disorders (eg celiac disease or food allergy);
* had any diabetes complications (eg neuropathy, nephropathy or retinopathy);
* diagnosed for \<1 year;
* were using corticosteroid or any medication that could effect gastric emptying;
* did exercise or had hypoglycemia or ketoacidosis within 24 hour before the test meals;
* had overweight or obese (BMI z score: ≥ 1SD and ≥ 2SD respectively);
* had not on follicular or peri-ovulatory phases of their menstrual cycles (for females).

Primary outcomes:
measure: Change Postprandial Glucose Concentrations
timeFrame: 0-240 minutes
Secondary outcomes:
measure: Postprandial insulin need
timeFrame: [Time Frame: 0-240 minutes]
Other outcomes:
Locations:
Study officials:
References:
citation: Kaya N, Kurtoglu S, Gokmen Ozel H. Does meal-time insulin dosing based on fat-protein counting give positive results in postprandial glycaemic profile after a high protein-fat meal in adolescents with type 1 diabetes: a randomised controlled trial. J Hum Nutr Diet. 2020 Jun;33(3):396-403. doi: 10.1111/jhn.12711. Epub 2019 Oct 24.
Clinical trial NCT04174625: The Effect of Omega 3 on 25 Hydroxyvitamin D
Official title: The Effect of Omega 3 Supplementations on Serum 25 Hydroxyvitamin D Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 25-hydroxyvitamin D Levels
Keywords: omega 3
25 hydroxyvitamin D
25OHD
Vitamin D
Lead sponsor: Applied Science Private University
Sponsor class: OTHER
First posted: 2019-11-22
Enrollment: 80
Sex: ALL
Minimum age (years): 22
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The effect of omega 3 fatty acid on serum 25-hydroxyvitamin D levels.

Detailed description: No data are available on the effect of omega 3 on serum 25-hydroxyvitamin D levels in Jordanian men and women.

This study was designed to investigate whether omega 3 supplementation has a potential effect on the reducing of serum 25-hydroxyvitamin D levels.

This randomized, placebo-controlled clinical trial (RCT) was designed to evaluate 300 mg omega-3FA daily for 2 months on serum levels of 25-hydroxyvitamin D levels. This RCT will be conducted on 80 to 90 Jordanian men and women aged 22 to 66 years. Baseline and follow-up levels for 25-hydroxyvitamin D (25OHD), parathyroid hormone (PTH), calcium, phosphate, liver and kidney functions will be assayed.

Eligibility criteria: Inclusion Criteria:

Age ≥18 years old

Male and female Jordanian ASU students and employees who live in Amman.

Informed written consent from the participant prior to the start of the study.

a serum 25(OH)D concentration between 10 and 70 ng/mL.

Exclusion Criteria:

Any eligiable subject refuses to apply with informed written consent before the start of the study.

Men or women previously diagnosed with chronic diseases, including kidney disease or GIT problems.

Who are receiving vitamin D3 supplements (3 months before the start of the study) .

Pregnants,Breastfeeding females ,Females using hormonal contraceptives

Primary outcomes:
measure: serum concentrations of 25-hydroxyvitamin D
timeFrame: 8 weeks
measure: serum concentrations of PTH
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
measure: serum concentration of calcium
timeFrame: 8 weeks
measure: serum concentration of phosphate
timeFrame: 8 weeks
measure: serum ALT
timeFrame: 8 weeks
measure: Serum urea
timeFrame: 8 weeks
Locations:
city: Amman
country: Jordan
facility: Mahmoud S Abu-Samak
Study officials:
affiliation: Department of Clinical Pharmacy and Therapeutics
name: Mahmoud S Abu-Samak, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02060825: The Use of Optical Oximetry in Determining Gastrointestinal Complications After the Hybrid Procedure
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Congenital Heart Disease
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2014-02-12
Enrollment: 16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing surgical repair of hypoplastic left heart syndrome.

Brief summary: This project is evaluating the validity of regional saturation monitoring in evaluating changes in the mesenteric perfusion. Regional saturation monitoring is a standard of care in many institutions, including NCH. Advances in the technology and recent approval of the use of CASMED devices for this purpose will allow us to use this technology more effectively. We aim to evaluate if there is a change in the mesenteric blood flow during the pre, intra and post operative period for the hybrid procedure and the balloon atrial septostomy procedure (BAS).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of single ventricle and undergoing the hybrid procedure pathway.

Exclusion Criteria:

* None

Primary outcomes:
measure: Intestinal perfusion
timeFrame: Immediate post-op period (24 - 96 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT04253925: Effect of Global Postural Correction Exercises on Stress Urinary Incontinence During Pregnancy: A Randomized Controlled Trial
Official title: Effect of Global Postural Correction Exercises on Stress Urinary Incontinence During Pregnancy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: Kegel exercise
Postural Correction
Stress Urinary Incontinence
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 40
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: One of the many consequences of pregnancy that may negatively affect a woman's quality of life is stress urinary incontinence caused by activities of daily living especially those associated with increased intraabdominal pressure. Objective: This study aimed to investigate the effect of global postural correction exercises on stress urinary incontinence among pregnant women. Participants and Methods: Forty primigravida women (aged between 30-39 years), with a single fetus, diagnosed with stress urinary incontinence participated in the study. Participants were assigned randomly into two groups: Study group (group A; n=20) and control group (group B; n=20). The participants were tested twice, before and after a 12-week period, during which group A received global postural correction exercises in addition to Kegel exercises, while group B performed only Kegel exercises. A perineometer was used to evaluate the change in vaginal squeeze pressure both before and after conducting the study. Urogenital Distress Inventory Questionnaire (UDI-6) was used to assess changes in incontinence severity symptoms.


Eligibility criteria: Inclusion Criteria:

* Forty primigravida women with singleton fetus in their third trimester and diagnosed with pregnancy related SUI participated in this study.

All participants suffered from a mild to moderate grade of SUI identified by clinical grading (Ingelman-Sundberg) (Wlazlak et al., 2015) as follows: Grade I (mild), the leakage of urine occurs on straining; and grade II (moderate), the leakage occurs following abrupt movement

Exclusion Criteria:

* Females were excluded from the study if they had severe grade SUI; infections in their lower urinary tract; neurological conditions; gestational diabetes; and chronic chest diseases. Females who smoked, used any medications or medical/surgical interventions for SUI, or who suffered any other type of urinary incontinence were also excluded from the study

Primary outcomes:
measure: strength of pelvic floor muscle
timeFrame: change from Baseline strength of pelvic floor muscle at 12-weeks
Secondary outcomes:
measure: Urogenital Distress Inventory Questionnaire
timeFrame: change from Baseline Urogenital Distress Inventory Questionnaire (UDI-6) at 12-weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01260025: Tolerability and Pharmacokinetics of M2ES in the Treatment of Advanced Solid Tumor
Official title: Dose Escalation Study of Tolerability and Pharmacokinetics of PEDylated Recombinant Human Endostatin(M2ES)in the Treatment of Advanced Solid Tumor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tolerability
Pharmacokinetics
Endostatin
Keywords: Tolerability
Pharmacokinetics
Endostatin
antiangiogenesis
cancer
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2010-12-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 1. MTD and DLT of M2ES
2. Pharmacokinetics of M2ES

Detailed description: Patients received infusion of M2ES for 120 minutes weekly（d1,d8,d15）by calculated pump and underwent evaluation of vital signs including blood pressure, pulse, respiratory rate, and temperature before treatment, at intervals during infusion, and hourly for 6 hours after infusion. After infusion, patients underwent serial pharmacokinetic sampling. All patients were seen weekly during the study therapy and follow-up and underwent evaluation with physical examination including ECOG performance status, vital signs, and laboratory evaluation with complete blood count with manual differential, chemistry evaluation, prothrombin time/partial thromboplastin time, and urinalysis.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 65 years;Genders eligible for study: both;
* Histologic diagnosis of solid malignancies ;
* Performance status of 0 or 1;
* Tumor not amenable to standard curative or palliative therapy;
* life expectancy beyond 3 months;
* Ability to give signed informed consent

Exclusion Criteria:

* Pregnancy or lactation;
* Had a history of brain metastasis or a primary brain tumor;
* An active, potentially severe autoimmune disease;
* Serum creatinine ≥1.5mg/dl or a calculated creatinine clearance \<60ml/min; WBC count \< 2.0×109/L，hemoglobin \< 90g/L，and platelet count \< 100×109/L; Total bilirubin value \< 2.0 times the upper limit of normal (ULN), ALT level \< 2.0 times ULN, AST \< 2.0 times ULN;
* Positive of anti-HIV antibodies;
* An active infection;
* had received chemotherapy or immunotherapy within the prior 4 weeks before study entry
* Participation in a clinical study during the last 28 days
* QTc with Bazett's correction unmeasurable or ≥ 480 msec on screening ECG

Primary outcomes:
measure: Maxinum tolerated dose of M2ES
timeFrame: one month
Secondary outcomes:
measure: Tumor response rate
timeFrame: one month
measure: Pharmacokinetic effect
timeFrame: one month
measure: DLT of M2ES
timeFrame: one month
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Li Zhang, Professor
role: PRINCIPAL_INVESTIGATOR
References: