louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05939102: Eighteen-month Orthodontic Bracket Survival Rate With the Conventional Bonding Technique Versus RMGIC and V-prep
Official title: Eighteen-month Orthodontic Bracket Survival Rate With the Conventional Bonding Technique Versus RMGIC and V-prep: A Split-mouth RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Malocclusion
Keywords: resin-modified glass ionomer
surface preparation
orthodontic bracket
Lead sponsor: Saint-Joseph University
Sponsor class: OTHER
First posted: 2023-07-11
Enrollment: 25
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to evaluate over eighteen months the clinical bonding failure and survival rates of the conventional bonding technique using the Transbond XT (3M Unitek, Monrovia, California, USA) and the RMGIC Fuji Ortho LC (GC Corporation, Tokyo, Japan) prepared with the V-prep. Therefore, one operator using the straight-wire technique bonded two hundred metallic brackets to upper and lower premolars of twenty-five patients requiring an orthodontic treatment. The randomized trial was a single-blind design in a split-mouth comparison. Each patient was randomly allocated one of the two bonding systems for each premolar on each side of the mouth. The bonding and rebonding techniques were standardized throughout the trial and bond failure was recorded each month for a period of eighteen months.


Eligibility criteria: Inclusion Criteria:

* require full orthodontic treatment of both arches
* mild or average overbite and crowding
* no restorations on the buccal surface of the premolars

Exclusion Criteria:

* Patients with required extractions in the treatment plan or with poor oral hygiene

Primary outcomes:
measure: Bracket bonding survival rate
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Saint Joseph University
Study officials:
affiliation: Saint-Joseph University
name: Victor Ghoubril, Ms
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ghoubril V, Changotade S, Lutomski D, Ghoubril J, Chakar C, Abboud M, Hardan L, Kharouf N, Khoury E. Cytotoxicity of V-Prep Versus Phosphoric Acid Etchant on Oral Gingival Fibroblasts. J Funct Biomater. 2022 Nov 28;13(4):266. doi: 10.3390/jfb13040266.
citation: Ghoubril V, Ghoubril J, Khoury E. A comparison between RMGIC and composite with acid-etch preparation or hypochlorite on the adhesion of a premolar metal bracket by testing SBS and ARI: In vitro study. Int Orthod. 2020 Mar;18(1):127-136. doi: 10.1016/j.ortho.2019.07.003. Epub 2019 Sep 5.
Clinical trial NCT02733302: Hope Theory as Ability Determinant to Permanently Change the Adapted Physical Activity (APA) in Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2016-04-11
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The control of diabetes is related both to food, treatment but also to physical activity. Despite these recommendations and these positive findings, patients are always sedentary because of brakes in the practice of a regular physical activity.

It is therefore interesting to consider the representations of patients and particularly on the way of establishment in order to reach a goal. The Hope Theory highlights the hope as the sum of the will and means that an individual has to achieve its goals. Will be discussed in this study to identify a relationship between the level of hope for patients and their ability to permanently change their behavior in regular physical activity as part of the goals set during the week of therapeutic education patient.


Eligibility criteria: Inclusion Criteria:

* Major Topic
* Type 2 Diabetic Topic
* Inactive Topic
* Subject of CHU ANGERS hospitalized for a week Diab'Equilibre, Diabetology Service
* Subject participating in the service of the APA program
* Subject who understands and reads French
* Subject has given its consent to participate signed the protocol

Exclusion Criteria:

* Removing the participation of consent;
* Severe heart failure
* Severe respiratory failure
* Bone metastases

Primary outcomes:
measure: IPAQ-SF questionnaire for measure of Physical Activity
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: UHAngers
Study officials:
References:
Clinical trial NCT04357002: Intravenous Tranexamic Acid Versus Vaginal Dinoprostone in Abdominal Myomectomy
Official title: Evaluating Safety and Efficacy of Intravenous Tranexamic Acid Versus Vaginal Dinoprostone in Reducing Intraoperative Blood Loss During Abdominal Myomectomy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Myomectomy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-04-22
Enrollment: 180
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the aim of the present study is to evaluate safety and efficacy of intravenous tranexamic acid versus vaginal dinoprostone in reducing intraoperative blood loss during abdominal myomectomy


Eligibility criteria: Inclusion Criteria:

* symptomatic fibroids candidate for abdominal myomectomy

Exclusion Criteria:

* patients candidate for laparoscopic or hysteroscopic myomectomy or had contraindications or allergy to dinoprostone or tranexamic acid

Primary outcomes:
measure: intraoperative blood loss
timeFrame: one hour
Secondary outcomes:
measure: blood transfusion
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00888602: Study to Evaluate the Effects of Psyllium on Blood Glucose
Official title: An Open Label, Randomized, 4-Period Cross-over Study to Evaluate the Effects of Psyllium Taken Before a Meal on Postprandial Blood Glucose in Healthy Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Men
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2009-04-27
Enrollment: 49
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This is an open label, single use, randomized, 4-period cross-over study. In each period, subjects will receive one of 4 test combinations. Blood will be drawn prior to study product consumption and following study product consumption for glucose measures.


Eligibility criteria: Inclusion Criteria:

* male
* 18 to 50 years of age
* general good health
* Body Mass Index (BMI) in the range of 18.5-29.9 kg/m2
* fasting plasma blood glucose \<126mg/dL
* not actively treated for high blood glucose
* willing and able to have blood drawn at multiple times during each 4 visits

Exclusion Criteria:

* history of allergy or hypersensitivity to inhaled or ingested psyllium or meal ingredients
* Phenylketonuria (PKU)
* an eating disorder
* following special medical or weight-loss dietary restrictions
* taking dietary supplements or prescription medication for the purpose of weight loss/management

Primary outcomes:
measure: to evaluate the effect of 2 dosing levels of psyllium on glucose in blood when taken prior to a meal vs. a meal alone
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Miamiville
country: United States
facility: Hill Top Research
state: Ohio
Study officials:
References:
Clinical trial NCT01575002: Effects of Transcranial Direct Current Stimulation (tDCS) in Chronic Corneal Pain
Official title: Neural Correlates of Pain-related Cognitive Processing in Chronic Pain of the Cornea: an ERP and Electrical Stimulation Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Corneal Pain
Chronic Pain
Neuropathic Pain
Keywords: transcranial stimulation
direct current stimulation
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2012-04-10
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: In this study the investigators aim to examine the effects of Transcranial Direct Current Stimulation (tDCS) on pain levels as well as the changes in cognitive (thought) processing in individuals with chronic pain of the cornea -- and also compared with healthy controls.


Eligibility criteria: Inclusion Criteria (for all subjects):

1. Provide informed consent to participate in the study;
2. 18 to 65 years old;

Additional Inclusion Criteria for Subjects with Chronic Corneal Pain:

1. Corneal pain for six months or more;
2. Referral from a corneal specialist (Dr. Perry Rosenthal) with refractoriness to conventional ophthalmologic treatments for corneal pain such as local topical medications and soft bandage contact lenses;
3. Report a Visual Analogue Scale (VAS) for pain of 4 or greater in the previous 3 weeks;

Exclusion Criteria (for all subjects):

1. History of alcohol or substance abuse within the last 6 months as self-reported;
2. Diagnosis of any neurological diseases (such as epilepsy);
3. Episodes of seizures within the last 6 months;
4. Unexplained loss of consciousness
5. Use of carbamazepine or neuropsychotropic drugs
6. Contraindications to tDCS

   * Metal in the head
   * Implanted brain medical devices
7. Pregnant at time of enrollment

Primary outcomes:
measure: Changes in pain scales
timeFrame: Measured for approximately 2 weeks
Secondary outcomes:
measure: Changes in EEG measurements
timeFrame: Measured for approximately 2 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Spaulding Rehabilitation Hospital
state: Massachusetts
Study officials:
affiliation: Spaulding Rehabilitation Hospital
name: Felipe Fregni, MD PHD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00362102: A Phase II Study of Cetuximab Plus Irinotecan in Patients With EGFR-detectable Metastatic Colorectal Carcinoma
Official title: A Multi-center, Open Label, Non-randomized, Phase II Study to Assess the Activity and Safety of Cetuximab Plus Irinotecan in Subjects With EGFR-detectable Metastatic Colorectal Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Carcinoma
Keywords: EGFR-detectable metastatic colorectal carcinoma with documented progressive disease to irinotecan-based chemotherapy and failure
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2006-08-09
Enrollment: 38
Sex: ALL
Minimum age (years): 20
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: To evaluate the response rate of cetuximab plus irinotecan combination therapy in subjects with EGFR-detectable metastatic colorectal carcinoma who have documented progressive disease to irinotecan-based chemotherapy and who have failed (progressive disease or intolerance) previous oxaliplatin-based and fluoropyrimidine-based chemotherapies.


Eligibility criteria: Inclusion Criteria:

* The subject must have surgically unresectable metastatic colorectal carcinoma.
* The subjects who have received and failed Ilinotecan, oxaliplatin and fluoropyrimidine-based chemotherapy
* ECOG PS 0-2

Exclusion Criteria:

* Subjects with symptomatic cerebral metastasis

Primary outcomes:
measure: Response according to the RECIST criteria accessed every 6 weeks
Secondary outcomes:
measure: Time to progression, duration of achieved response, and the disease control rate will be accessed in all patients who received Cetuximab. The worst toxicity grades per patients will be tabulated for adverse events and laboratory measurements.
Other outcomes:
Locations:
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
citation: Tahara M, Shirao K, Boku N, Yamaguchi K, Komatsu Y, Inaba Y, Arai T, Mizunuma N, Satoh T, Takiuchi H, Nishina T, Sakata Y. Multicenter Phase II study of cetuximab plus irinotecan in metastatic colorectal carcinoma refractory to irinotecan, oxaliplatin and fluoropyrimidines. Jpn J Clin Oncol. 2008 Nov;38(11):762-9. doi: 10.1093/jjco/hyn102. Epub 2008 Oct 4.
Clinical trial NCT01940302: Dietary Supplement of LEHEL for the Patients With Type 2 Diabetes
Official title: Metabolic Control Before and After Supplementation With LEHEL in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Type 2 Diabetes
Keywords: Malnutrition; Metabolic disorders
Lead sponsor: Shaoguan University
Sponsor class: OTHER
Collaborators: name: Sun Yat-sen University
First posted: 2013-09-12
Enrollment: 71
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Due to metabolic disorders and dietary restrictions, patients with diabetes may have different degrees of malnutrition. The primary objective of this study is to investigate whether supplementation of LEHEL, a multi-nutrients supplement, is capable to improve metabolic parameters in patients with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Subject is diagnosed with type 2 diabetes mellitus according to the Chinese type 2 diabetes prevention guide 2010, diagnostic criteria are as follows:

  (1) Diabetes symptoms（polydipsia、polyphagia, polyuria, weight loss、skin itching、blurred vision and other acute metabolic network disorder that caused by high blood sugar）combined with random blood sugar ≥11.1 OR, (2) fasting plasma glucose (FPG) ≥7.0 OR, (3) 2 h blood sugar after oral glucose tolerance test (OGTT) ≥11.1;
* Subject is between 18 and 75 years of age, inclusive.
* Subject's BMI is \>18.5 kg/m2 and \<35 kg/m2.
* If on a chronic medication such as anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, subject has been on constant dosage for at least two months prior to screening visit.

Exclusion Criteria:

* Subject that is diagnosed as type 1 diabetes, gestational diabetes and other kinds of diabetes expect type 2.
* Subject that use exogenous insulin for glucose control.
* Subject that has a history of diabetic ketoacidosis.
* Subject that has mental disorder, cancer, cirrhosis, renal disease and hepatic disease.
* Subject that has had a significant cardiovascular event less than six months prior to screening visit or has history of congestive heart failure.
* Subject that has had operation less than six months prior to screening visit.
* Subject that has taken/is currently taking any dietary supplements or medications that could profoundly affect blood glucose during the past one month prior to screening visit.
* Subject is known to be allergic or intolerant to any ingredient found in the study product.

Primary outcomes:
measure: Metabolic Control
timeFrame: Twelve weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Shaoguan
country: China
facility: Shaoguan University
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Wenhua Ling, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01214902: Constraint Induced Movement Therapy (CIMT) in Babies Home Program
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemiplegia
Cerebral Palsy
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2010-10-05
Enrollment: 30
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The research objectives are to test the efficacy of a Modified CIMT treatment in babies diagnosed with hemiplegia, treated in a home program, as compared to a control group of babies receiving a parallel home program but with no CIMT.


Eligibility criteria: Inclusion Criteria:

* Babies age 7-18 months diagnosed with Hemiplegic cerebral palsy

Exclusion Criteria:

* Epilepsy not treated

Primary outcomes:
measure: Assistive Hand Assessment
timeFrame: after two months of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: ShaareZMC
Study officials:
References:
citation: Chamudot R, Parush S, Rigbi A, Horovitz R, Gross-Tsur V. Effectiveness of Modified Constraint-Induced Movement Therapy Compared With Bimanual Therapy Home Programs for Infants With Hemiplegia: A Randomized Controlled Trial. Am J Occup Ther. 2018 Nov/Dec;72(6):7206205010p1-7206205010p9. doi: 10.5014/ajot.2018.025981.
citation: Chamudot R, Parush S, Rigbi A, Gross-Tsur V. Brain Lesions as a Predictor of Therapeutic Outcomes of Hand Function in Infants With Unilateral Cerebral Palsy. J Child Neurol. 2018 Dec;33(14):918-924. doi: 10.1177/0883073818801632. Epub 2018 Oct 11.
Clinical trial NCT04488302: Ultrasonography and Cone-Beam Computed Tomography for Peri-implant Tissue Evaluation
Official title: A Retrospective Study on Use of Ultrasonography and Cone-Beam Computed Tomography for Evaluating Peri-implant Tissue
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ultrasonography
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2020-07-27
Enrollment: 4
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: See eligibility criteria

Brief summary: Objectives: Although cone-beam computed tomography (CBCT) is becoming a standard of care in implant therapy, concerns have been raised recently about its limitation in imaging peri-implant tissues due to artifacts. The aim of present study was to demonstrate the complementary role of ultrasound (US), for a comprehensive examination of peri-implant tissues in live humans. Material and Methods: Patients with \> 1 implant, a CBCT scan, an US scan, and clinical photographs taken during the open-bone surgery were included. The crestal bone thickness (CBT) and facial bone level (FBL) were measured on both modalities, and direct FBL measurements were also made on clinical images. The correlation plots were made to evaluate the measurement agreements between the 3 methods.


Eligibility criteria: Inclusion Criteria:

* the patients had to have ≥ 1 implant with a CBCT scan, US scan, and clinical photographs taken during the surgery, e.g. a revision/explantation surgery due to peri-implantitis or a 2nd stage uncover surgery.

Primary outcomes:
measure: Crestal bone thickness
timeFrame: up to 100 months after implant surgery.
Secondary outcomes:
measure: Facial bone height
timeFrame: up to 100 months after implant surgery.
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
References:
Clinical trial NCT00514202: Pilot Study Examining Effect for Dextroamphetamine to Treat Cocaine Dependence Plus Attention-deficit Hyperactivity Disorder (ADHD)
Official title: Dextroamphetamine Treatment for Comorbid Cocaine Dependence and ADHD
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Attention Deficit Disorder With Hyperactivity
Cocaine-Related Disorders
Substance-Related Disorders
Keywords: cocaine
ADHD
attention
hyperactivity
drug
dependence
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2007-08-09
Enrollment: 5
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: Dextroamphetamine is commonly used to treat ADHD, and recent evidence suggests that this medication may decrease drug use in individuals dependent on cocaine. Thus, the present pilot study will determine the ability of dextroamphetamine to treat individuals with both cocaine dependence and ADHD.

Detailed description: This double-blind, placebo-controlled pilot study will determine the ability of dextroamphetamine to treat comorbid cocaine dependence and ADHD. Participants will be randomly assigned on receive placebo or Dextroamphetamine SR (60 mg/day) during a 12-week study period. All participants will receive weekly cognitive behavioral therapy.

Eligibility criteria: Inclusion Criteria:

* Provide informed consent
* Generally good health except for problems related to drug use
* Meet DSM criteria for cocaine dependence and ADHD
* Have stable living situation

Exclusion Criteria:

* DSM diagnosis for current psychotic, anxiety disorders as well as current substance dependence (with the exception of marijuana and nicotine)
* Current use of prescription medications
* Females who are currently pregnant or nursing
* History of significant acute or chronic physical illness
* History of or current liver disease
* Existing cardiovascular disease
* Plans to leave metropolitan area within 3 months
* Probation or parole with constraints that preclude full study participation

Primary outcomes:
measure: Substance use
timeFrame: Duration of study
measure: ADHD symptoms
timeFrame: Duration of study
Secondary outcomes:
measure: Treatment retention
timeFrame: Duration of study
measure: Cocaine craving
timeFrame: Duration of study
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Health Science Center
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: David V Herin, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: