louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02682056: Glucose Measurement Using Microneedle Patches
Official title: Glucose Measurement Using Microneedle Patches
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Pediatrics
Endocrinology
Adolescent
Microneedle
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2016-02-15
Enrollment: 15
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will compare three glucose measurement techniques among diabetic children and adolescents. The study seeks to determine if a microneedle patch (made from biocompatible polymers or metal), versus a lancet or intravenous catheter, would be a preferable option for monitoring glucose levels among the diabetic pediatric population.

Detailed description: Fifteen children and adolescents with diabetes will be tested for their glucose measurements comparing interstitial fluid collected via a microneedle patch (made from biocompatible polymers or metal), versus the standard of care blood sample (lancet), and lab grade blood draw (intravenous catheter). Samples will be taken hourly from all three devices for four hours. All four measurements will be compared against each other to see how close they are with measuring the glucose values. Each participant will be asked to rate their apprehension prior to receiving each method for blood or interstitial fluid collection as well as the pain associated with each method immediately after collection.

Eligibility criteria: Inclusion Criteria:

* Diabetes diagnosis

Exclusion Criteria:

* no exclusion criteria are specified

Primary outcomes:
measure: Glucose Level
timeFrame: Baseline (Hour 1), Hour 2, Hour 3, Hour 4
Secondary outcomes:
measure: Apprehension Level Assessed by Apprehension Visual Analog Scale (VAS)
timeFrame: Baseline ( Hour 1), Hour 4
measure: Pain Level Assessed by Pain Visual Analog Scale (VAS)
timeFrame: Baseline ( Hour 1), Hour 4
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: Atlanta
country: United States
facility: Emory Children's Center
state: Georgia
Study officials:
affiliation: Emory University
name: Eric Felner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06826456: Effect of Er,Cr:YSGG Sub-Ablative Laser Irradiation on Fissure Caries Prevention in Permanent Molars
Official title: Effect of Er,Cr:YSGG Sub-Ablative Laser Irradiation on Fissure Caries Prevention in Permanent Molars
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Caries,Dental
Keywords: Er,Cr:YSGG
laser
DIAGNOdentTM
acid resistance
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Subjecting human dental enamel to sub-ablative laser has been suggested as a novel way of caries prevention. However, further studies are needed to establish its use as a routine clinical procedure for caries prevention.

The aim of this study: This study aims to evaluate the effect of Er,Cr:YSGG subablative laser irradiation on caries resistance of occlusal fissures of permanent molars.

Materials and methods: In-vivo study, a split mouth randomized controlled trial with sixty patients having two fully erupted bilateral first permanent molars (ICDAS-II score 0,1 or 2). The pits and fissures will be subjected to sub-ablative power of Er,Cr:YSGG Laser (Group 1, n=90) and will be compared with fluoride varnish application on the first permanent molars in the same arch(Group 2,n=90). DIAGNOdentTM readings and changes in ICDAS-II score will be assessed at base line and at 3,6,9 and 12 months follow-up.


Eligibility criteria: Inclusion Criteria:

* Participants of age 6-12 years old
* Patients ranking definitely positive or positive on Frankl behavior rating scale
* Having at least two bilateral fully erupted first permanent molars with untreated non-cavitated occlusal surfaces with deep grooves, the included teeth will have International Detection and Assessment System (ICDAS-II)/ severity scores 0, 1 or 2
* Initial DIAGNOdent Score not exceeding value of 25 indicating only enamel involvement
* Patients whom their parents are willing to comply with all study procedures and protocols and will be given an informed consent to participate

Exclusion Criteria:

* Patients with any known medical history of systemic diseases
* Patients having first permanent molar with hypoplastic or hypocalcified enamel
* Patients using medications that may affect the oral flora or salivary flow
* Patients treated with in-office fluoride treatment within the last 3 months prior to being enrolled in the study.
* Patients showing evidence of poor oral hygiene according to Silness and Löe plaque index

Primary outcomes:
measure: Diagnodent scoring
timeFrame: day 0, 3 months, 6 months, 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University
Study officials:
References:
Clinical trial NCT05926856: High Quality Fluorescent Cholangiography
Official title: Comparison of the Fluorescent Visualization of the Extrahepatic Biliary Tract Between Two Injection Protocols
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Extrahepatic Biliary Tree Injury
Keywords: icg
fluorescent cholangiograph
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this randomized controlled trial is to compare the quality of extrahepatic biliary fluorescent visualization under two injection protocols to optimize extrahepatic biliary cholangiography.

Detailed description: Biliary fluorescence imaging is widely used to identify the extrahepatic biliary tract during laparoscopic cholecystectomy. However, fluorescent developer Indocyanine Green（ICG） still lacks standardization, and not every visualization of the extrahepatic biliary tract is satisfactory. Some research groups have shown that injection of ICG 1 day before surgery can achieve the best fluorescence imaging of the biliary tract, but some research groups have suggested that injection of a very low dose of ICG 45 minutes before surgery can improve the satisfaction of fluorescence imaging. However, no study compares the quality of biliary fluorescence imaging between the two injection protocols. This study will compare the fluorescence imaging effects of the two schemes to obtain the best injection scheme at present and standardize the use of icg.

Eligibility criteria: Inclusion Criteria:

1. The patient has indications for cholecystectomy and requires laparoscopic treatment；
2. No biliary obstruction or cholestasis was found during preoperative examination；3.Volunteer to participate in this clinical trial and sign written informed consent.

Exclusion Criteria:

1. Patients who require emergency surgical treatment；
2. Patients with malignant tumors of the biliary tract；
3. Patients with a history of abdominal surgery；
4. Patients who are allergic to indocyanine green or iodine contrast agents；5.Patients participating in one or more other clinical trials simultaneously；

6.Patients who have received medication that affects bile excretion within 2 weeks before surgery； 7.Other situations that have been judged unsuitable for inclusion by researchers.

Primary outcomes:
measure: Common bile duct-to-liver fluorescence intensity ratio
timeFrame: Intraoperative (The beginning of the surgery)
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Southern Medical University
state: Guangdong
Study officials:
affiliation: Zhujiang Hospital
name: Jian Yang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04710056: Expanded Access to REGN4461 for Patients With Lipodystrophy or Monogenic Obesity With Complications of Leptin Deficiency or Deficient Leptin Signaling
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Keywords: Leptin (LEP)
Leptin Receptors (LEPR)
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2021-01-14
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Provide Expanded Access to REGN4461 for patients with lipodystrophy or monogenic obesity with complications of leptin deficiency or deficient leptin signaling

Detailed description: Expanded Access requests are only being considered in response to Individual Patient Investigational New Drug (IND) applications. Availability will depend on location.


Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06509256: Different Methods of Tranexamic Acid Application in Controlling Peri Operative Bleeding in Gynecomastia Surgery
Official title: Different Methods of Tranexamic Acid Application in Controlling Perio Operative Bleeding in Gynecomastia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Pharmacological-Aggravated Urticaria
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-07-19
Enrollment: 50
Sex: MALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Different Methods of Tranexamic Acid Application in Controlling Peri-Operative Bleeding in Gynecomastia Surgery

Detailed description: The term "gynecomastia" is derived from the Greek words "gyne" = woman and "mastos" = breast and is a benign enlargement of the male breast. It is the most common condition affecting the male breast due to enlargement of both ductal and stromal tissue\[1\].

Plastic surgeons frequently perform gynecomastia operations as cosmetic procedures. Since these operations result in relatively little blood loss, there is little information in the literature about how to minimise blood loss during these cosmetic procedures Some preventive measure against bleeding and hematomas include perioperative blood pressure control, use compressive dressing, different types of suction drains, size of incision, careful hemostasis, and infusion of adrenalin during local anesthesia, infusion of tranexamic acid in tumescent or intravenous directly

Eligibility criteria: Inclusion Criteria:

* Age (16 - 45 years)
* Any grade of gynecomastia well be included

Exclusion Criteria:

* Age (\<16 - \>40 years)
* History of previous gynecomastia surgery
* Patients with known allergy to tranexamic acid
* Patients with abnormal coagulation profile (according to American Society of Anesthesiologists guidelines for preoperative preparation of surgical patients)
* Patients who are receiving treatment for known hyper-coagulable state. 6. Patients with history of cardiac disease or thromboembolic events.

Primary outcomes:
measure: Intraoperative blood loss during liposuction in milliliters
timeFrame: "Intraoperatively" Unit of Measure: Milliliters (mL)
Secondary outcomes:
measure: Duration of surgical drain placement in days
timeFrame: From immediate post-operation until drain removal (expected within 3 to 7 days)" Unit of Measure: Days
measure: Change in hemoglobin concentration from baseline to 24 hours post-operation
timeFrame: Baseline (within 24 hours before surgery) and 24 hours post-operation" Unit of Measure: Grams per deciliter (g/dL)
measure: Extent of post-operative ecchymosis at 7 days
timeFrame: "7 days post-operation" Unit of Measure: Ordinal scale score (0-4)
measure: Changes in coagulation profile at 24 hours post-operation
timeFrame: "Baseline (within 24 hours before surgery) and 24 hours post-operation" Unit of Measure: Seconds for PT and aPTT, no units for INR
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03259256: Islet Allotransplantation for Type 1 Diabetic Patients
Official title: Islet Allotransplantation for Type 1 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Type 1 Diabetic
Lead sponsor: Second Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2017-08-23
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
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 if islet cell transplantation , is an effective treatment for type 1 diabetes. Study participants may receive up to three islet transplants and will be followed for five years to monitor blood sugar control, islet transplant function, and changes in quality of life.


Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of type 1 diabetes 18 \<Age \<70 years Evolution of diabetes for more than 5 years Regular patient follow-up (\> or equal to 2 visits per year from the same diabetologist) ABO compatibility with the donor Cross match negative Anti-HLA antibodies (class I and / or class II) detected by lymphocytotoxicity \<20% Accepting patients effective contraception during the study period

Exclusion Criteria:

Clinical diagnosis of type 2 diabetes BMI \> 28 Need insulin \< 28 U per day Pregnancy, lactation Psychiatric Disorders Inability to communicate or cooperate with the investigator Lack of therapeutic compliance, including HbA1C \> 12% Chronic liver disease Proliferative retinopathy unstabilized History of cancer, whatever the date, except for basal or squamous cell skin cancers over 1 year.

Systemic infection Chronic high risk of requiring corticosteroids Need for long-term corticosteroid, outside that specified in renal transplantation, the patients will be weaned before transplantation Anticoagulant vitamin K or antiplatelet treatments Platelets \< 100 giga/L and/or neutrophils \<1.5 giga/L Chronic intoxication by alcohol, tobacco, or other substance (abstinence \> 6 months required) Active infection by hepatitis B, hepatitis C and HIV, HTLV-1-HTLV2 Ascites

-

Primary outcomes:
measure: Obtaining an improvement in glycemic control
timeFrame: nine months after first and last islet transplants
measure: normal glycemic control without insulin
timeFrame: 3 months after graf
Secondary outcomes:
measure: insulin independence
timeFrame: One year after the last transplant
measure: Hypoglycemic episodes by HYPO score
timeFrame: 3 months after transplantation
measure: degenerative complications of diabetes
timeFrame: 18 months after transplantation
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
affiliation: Second Affiliated Hospital of Guangzhou Medical University
name: ping Xue, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01813656: An Study of Aripiprazole in the Treatment of Methamphetamine Dependence
Official title: A Multiple-Center, Randomized, Double-Blind Study of Aripiprazole for Treatment of Methamphetamine Dependence
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Methamphetamine Dependence
Keywords: Methamphetamine-Associated Psychosis
Aripiprazole
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2013-03-19
Enrollment: 10
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Methamphetamine substance use is common worldwide. No approved pharmacologic treatments for methamphetamine dependence exist. Aripiprazole are Second generation antipsychotics，but have different pharmacological effects of neurotransmitters.To determine whether mirtazapine would reduce methamphetamine use among mehtamphetamine addicts.

Detailed description: Methods:A Multiple-Center, Randomized, Double-Blind.

Eligibility criteria: Inclusion Criteria:

1. Patients,Diagnostic and Statistical Manual of Mental Disorders 4thed. (DSM-IV) criteria for Methamphetamine dependence.
2. Must sign a Information consent form.
3. Required to provide detailed address and phone number

Exclusion Criteria:

1. Serious organic disease.
2. Suicide ideation or hurt others.
3. Taking antipsychotic within two weeks before.
4. drug allergy to Risperidone or Aripiprazole.
5. pregnancy and breastfeeding women.

Primary outcomes:
measure: abstinent time of Methamphetamine addict
timeFrame: up to 3 months
Secondary outcomes:
measure: number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central University
state: Hunan
Study officials:
affiliation: Central South University
name: Wei Hao, MD., Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03720756: Effect of a Nickel Free Diet and Nickel Sensitization on GERD Patients.
Official title: Effect of a Nickel Free Diet and Nickel Sensitization on GERD Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroesophageal Reflux
Keywords: nickel-free
diet
GERD
Gastroesophageal Reflux
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2018-10-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will undergo a patch test to determine if they are hypersensitive to nickel among other metabolites. Regardless of the results of the patch test, patients will be placed on a nickel-free diet for 8 weeks.
Primary purpose: TREATMENT

Brief summary: There is little evidence on the effect of a nickel-free diet on gastroesophageal reflux disease (GERD). We hope to determine if a nickel-free diet improves GERD symptoms in patients with a nickel allergy by having patients complete a questionnaire on their GERD symptoms before and after initiation of 8 weeks on a nickel-free diet.


Eligibility criteria: Inclusion Criteria:

* age 18 years or older with a history of GERD
* owns a phone with a camera
* has access to or is willing to sign up for MyChart
* is symptomatic for GERD at time of visit as determined by a score of \>12 on the GERD Health Related Quality of Life (GERD-HRQL) questionnaire. (Patients that are currently taking a proton pump inhibitor (PPI) they must have been on the PPI for at least 3 months.)

Exclusion Criteria:

* less than 18 years of age
* no not have access to MyChart
* are not willing to sign up for MyChart
* have taken an oral steroid within 4 weeks
* have experienced a sunburn or had significant sun exposure within the last 4 weeks, or applied a topical steroid to the area that the past test will be applied (i.e. upper back or arm) in the last 4 weeks. No vulnerable populations will be included.

Primary outcomes:
measure: Change in baseline Gastroesophageal reflux disease-Health Related Quality of Life (GERD-HRQL) Questionnaire score
timeFrame: after 8 weeks on nickel-free diet
Secondary outcomes:
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: WVU Medicine University Town Center
state: West Virginia
city: Morgantown
country: United States
facility: Physician's Office Center at Ruby Memorial, Digestive Diseases
state: West Virginia
Study officials:
References:
citation: Yousaf A, Hagen R, Mitchell M, Ghareeb E, Fang W, Correa R, Zinn Z, Gayam S. The effect of a low-nickel diet and nickel sensitization on gastroesophageal reflux disease: A pilot study. Indian J Gastroenterol. 2021 Apr;40(2):137-143. doi: 10.1007/s12664-020-01090-3. Epub 2020 Nov 21.
Clinical trial NCT05230056: Digital Therapy in Shoulder Rehabilitation.
Official title: Effectiveness and Therapeutic Compliance of Digital Therapy in Shoulder Rehabilitation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Pain
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 22
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Digital therapy may provides real time visual feedbacks. Instrumented devices objectively quantify the patient's performance during rehabilitation and thus could be helpful for the personalization of the exercises.

The interactive ball of this trial allows measuring both movement and pressure applied on it. Therefore, the objectives of this study are: (i) to evaluate whether the use of a novel digital therapy gaming system was therapeutically relevant during shoulder rehabilitation; (ii) to understand whether the device was effective in improving patients' engagement in comparison to a control non-gaming rehabilitation program.


Eligibility criteria: Inclusion Criteria:

* impingement syndrome, capsulitis, tendon injuries, degenerative joint or tendon pathologies
* pain between 2/10 and 8/10 on a visual analogue scale

Exclusion Criteria:

* post-surgical patients
* inability to perform active exercises
* peripheral neurological deficits
* cervical-brachialgia
* algodystrophy

Primary outcomes:
measure: shoulder pain
timeFrame: From baseline up to two weeks
measure: shoulder strength
timeFrame: From baseline up to two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Nutrition and Exercise Lab, DSB, University of Padova
Study officials:
References: