louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06213558: The Effect of Rectangular Versus Square Archwire on Maxillary Canine Retraction
Official title: The Effect of Rectangular Versus Square Archwire on Maxillary Canine Retraction: A Split Mouth Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Canine Retraction
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 15
Sex: ALL
Minimum age (years): 16
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Effect of Rectangular Versus Square Archwire on Maxillary Canine Retraction

Detailed description: his split-mouth randomized clinical trial will be carried out to evaluate the effect of rectangular versus square archwire on maxillary canine retraction.

Eligibility criteria: Inclusion Criteria:

- Individuals in permanent dentition phase with Class II canine and molar relationship that requires extraction of maxillary first premolars.

Individuals that require absolute anchorage using mini-implant.

No previous orthodontic treatment.

Good oral health

Age: 16-22 years

Exclusion Criteria:

- Patients with skeletal asymmetries.

Patients with syndromes or dental anomalies.

Patients with previous orthodontic treatment.

Evidence of root resorption.

Any medication affecting orthodontic tooth movement.

Primary outcomes:
measure: Rate of canine retraction
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura
state: Daqahlya
Study officials:
affiliation: Mansoura University
name: Ahmed Ta Khalifa, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02102958: Nonvisual Foot Examination for People With Diabetes and Visual Impairment
Official title: Nonvisual Foot Examination for People With Diabetes and Visual Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Visual Impairment
Keywords: diabetes
visual impairment
foot care
diabetes self-management education
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
First posted: 2014-04-03
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Because people who have both diabetes and visual impairment have high risk for foot problems, prevention of ulcers and amputation is a high priority. Usual care in diabetes self-management education (DSME) is to teach them to seek sighted assistance for regular foot examination, yet clinical experience suggests that this advice is seldom heeded. One possible solution is to teach use of the nonvisual senses of touch and smell for a systematic, thorough foot self-examination. The purpose of this pilot study was to compare the efficacy, acceptability, and feasibility of nonvisual foot examination with usual care (examination of the visually impaired person's feet by a sighted family member or friend).


Eligibility criteria: Inclusion Criteria:

* over age 18
* diagnosed with either type 1 or type 2 diabetes
* stated they had visual impairment

Exclusion Criteria:

* unable to pass a brief decisional capacity test
* had a score above 80 on the near vision scale of the National Eye Institute Visual Functioning Questionnaire
* had bilateral lower extremity amputations
* by self-report were unable to sense light touch on two or more fingers or either hand

Primary outcomes:
measure: Frequency of foot examination at home
timeFrame: 6 months
Secondary outcomes:
measure: New foot problems discovered at home
timeFrame: 6 months
Other outcomes:
measure: Total new foot problems
timeFrame: 6 months
Locations:
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
Study officials:
affiliation: Case Western Reserve University
name: Ann S Williams, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01302158: Drug-drug Interaction Study With ASP1941 and Glimepiride
Official title: An Open-label, Randomized Crossover Study to Evaluate the Effect of ASP1941 on the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Glimepiride in Healthy Subjects and Vice Versa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: Drug-Drug interaction
ASP1941
Glimepiride
Healthy subjects
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2011-02-23
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: A study to investigate the effect of ASP1941 on the pharmacokinetics and safety of glimepiride (Part A) and to investigate the effect of glimepiride on the pharmacokinetics, safety and pharmacodynamics of ASP1941 (Part B).

Detailed description: Study includes two parts. Part A is to investigate the effect of multiple oral doses of ASP1941 on the pharmacokinetics of glimepiride, and Part B is to investigate the effect of multiple oral doses of glimepiride on the pharmacokinetics of ASP1941.

Eligibility criteria: Inclusion Criteria:

* BMI between 18.5 and 30 kg/m2, inclusive

Exclusion Criteria:

* Any of the liver function tests above the upper limit of normal
* Pulse \<40 or \>90 bpm; Systolic Blood Pressure \>140 mmHg; Diastolic Blood Pressure \> 90 mmHg

Primary outcomes:
measure: Effect of multiple doses of ASP1941 on the Pharmacokinetics of glimepiride
timeFrame: 14 days
Secondary outcomes:
measure: Effect of multiple doses of glimepiride on the Pharmacokinetics of ASP1941
timeFrame: 14 days
Other outcomes:
Locations:
city: Groningen
country: Netherlands
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Use Central Contact
role: STUDY_DIRECTOR
References:
Clinical trial NCT01442558: Comparison of Quality of Supraclavicular, Infraclavicular and Axillary Approach of Ultrasound-guided Brachial Plexus Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: relief
Intra-operative
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2011-09-28
Enrollment: 101
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the quality of 3 methods of ultrasound-guided brachial plexus blocks for surgical anesthesia


Eligibility criteria: Inclusion Criteria:

* ASA I-III physical status
* Surgery of distal arm, forearm or hand

Exclusion Criteria:

* Skin infection near block injection site
* Allergy to local anesthetics
* Peripheral neuropathy upper limb
* INR of more than 1.4
* Thrombocytopenia
* Opioid dependency
* Chronic pain syndrome
* Lack of orientation to person, place and time
* Patient refusal

Primary outcomes:
measure: Quality of 3 different approaches to brachial plexus block
timeFrame: Immediate
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
citation: Stav A, Reytman L, Stav MY, Portnoy I, Kantarovsky A, Galili O, Luboshitz S, Sevi R, Sternberg A. Comparison of the Supraclavicular, Infraclavicular and Axillary Approaches for Ultrasound-Guided Brachial Plexus Block for Surgical Anesthesia. Rambam Maimonides Med J. 2016 Apr 19;7(2):e0013. doi: 10.5041/RMMJ.10240.
Clinical trial NCT06220058: Comparing Polypropylene Mesh and "Small Bites" Technique in Emergency Colorectal Surgery's Midline Laparotomy Closure. Study for Incisional Hernia Prevention.
Official title: Comparison Between the Use of a Prophylactic Polypropylene Mesh and the "Small Bites" Technique in Midline Laparotomy Closure for Emergency Colorectal Surgery for Incisional Hernia Prevention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Incisional Hernia
Wound Infection
Keywords: colorectal cancer
Hernia Incisional
Wound infection
small bites
Lead sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Sponsor class: OTHER
First posted: 2024-01-23
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The 2023 World Journal of Emergency Surgery guidelines couldn't provide a recommendation for emergency abdominal wall closure due to insufficient consensus (\>80% required). Available evidence, predominantly retrospective and heterogeneous, lacks differentiation between urgent and elective colorectal surgeries. Therefore, we advocate for a study comparing laparotomy closures in emergency colorectal surgery to contribute evidence on incisional hernia incidence and subsequent complications.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with colorectal pathology requiring urgent surgical treatment via midline laparotomy.
* Patients undergoing urgent laparoscopic surgery but necessitating conversion to midline laparotomy.
* Urgent surgical intervention required at the level of the colon and/or rectum, even in the presence of other abdominal pathologies.
* Age over 18 years.
* Signed informed consent (IC) from the patient and the investigator.

Exclusion Criteria:

* Severe chronic obstructive pulmonary disease (COPD) according to the GOLD classification or decompensated COPD.
* BMI ≥ 35 kg/m2.
* Re-laparotomies.
* Patients with psychiatric illnesses, addictions, or any disorder hindering the understanding of the Informed Consent.
* Inability to read or comprehend any of the languages in the Informed Consent (Catalan, Spanish).

Primary outcomes:
measure: Incidence of incisional hernia.
timeFrame: One year surgery
Secondary outcomes:
measure: Incidence of wound infection
timeFrame: 30 postoperative days
measure: Morbidity and mortality rates
timeFrame: 90 postoperative days
Other outcomes:
Locations:
city: Girona
country: Spain
facility: Colorectal Surgery Section, Department of General and Digestive Surgery, University Hospital of Girona,
state: Catalunya
Study officials:
References:
Clinical trial NCT00207558: Blood Folate and Homocysteine Levels Following Administration of Folic Acid According to Different Daily Dosing Schedules:a Simulation of Food Fortification
Official title: Blood Folate and Homocysteine Levels Following Administration of Folic Acid According to Different Daily Dosing Schedules:a Simulation of Food Fortification
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neural Tube Defects - Spina Bifida and Anencephaly
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: Peking University
name: Ministry of Science and Technology of the People´s Republic of China
name: University of Florida
First posted: 2005-09-21
Enrollment: 1100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to examine whether the same total daily dosage of folic acid, when taken as a single daily dose or as multiple divided doses throughout the day, results in different blood folate and homocysteine levels at the conclusion of the study. Further, a comparison of blood folate and homocysteine levels among women taking daily low-dosage (100mcg) and standard- dosage (400mcg) folic acid with those of women taking daily or weekly high-dosage (4000mcg) folic acid will be conducted.


Eligibility criteria: Inclusion Criteria:

-women who have delivered a baby two to four years ago, whose child is still alive, who are not breast-feeding, who are not pregnant or planning to become pregnant within the next 9 months following enrollment, who are using an IUD for contraception, and who have not taken vitamin supplements during the past 3 months

Exclusion Criteria:

-women who have not delivered a baby two to four years ago, whose child is deceased, who are breast-feeding, who are currently pregnant or planning to become pregnant within the next 9 months following enrollment, who are not using an IUD for contraception, and who have taken vitamin supplements during the past 3 months

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Xianghe County
country: China
facility: Townships
state: Hebei
Study officials:
References:
citation: Chen MY, Rose CE, Qi YP, Williams JL, Yeung LF, Berry RJ, Hao L, Cannon MJ, Crider KS. Defining the plasma folate concentration associated with the red blood cell folate concentration threshold for optimal neural tube defects prevention: a population-based, randomized trial of folic acid supplementation. Am J Clin Nutr. 2019 May 1;109(5):1452-1461. doi: 10.1093/ajcn/nqz027.
citation: Crider KS, Zhu JH, Hao L, Yang QH, Yang TP, Gindler J, Maneval DR, Quinlivan EP, Li Z, Bailey LB, Berry RJ. MTHFR 677C->T genotype is associated with folate and homocysteine concentrations in a large, population-based, double-blind trial of folic acid supplementation. Am J Clin Nutr. 2011 Jun;93(6):1365-72. doi: 10.3945/ajcn.110.004671. Epub 2011 Apr 20.
Clinical trial NCT02888158: Laparoscopic Training With and Without Robotic Assistance for Surgical Internes: a Randomized Study
Official title: Laparoscopic Training With and Without Robotic Assistance for Surgical Internes: a Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Training
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2016-09-02
Enrollment: 34
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The primary objective of this study is to compare two groups of gynecologic/urologic/visceral internes in terms of the time required to perform a laparoscopic surgical intervention (nephrectomy) on an animal model (pig).

The two groups of internes differ by the type of training they received: (1) Pelvic-Trainer training with robotic assistance versus (2) Pelvic-Trainer training without robotic assistance.


Eligibility criteria: Inclusion Criteria:

* Intern registered for specialization in surgery (urological, visceral or gynecology-obstetrics)

Exclusion Criteria:

* The intern refuses to participate in the study
* The internal is not available for training and/or evaluation

Primary outcomes:
measure: The time (in minutes) required for the intern to perform a laparoscopic nephrectomy on an animal model (pig).
timeFrame: 6 months (3 months after a second training session on the Pelvic Trainer)
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier Cedex 5
country: France
facility: CHU de Montpellier - Hôpital Gui de Chauliac
city: Nîmes Cedex 09
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Vincent Letouzey, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04491058: Assessment of Subsynovial Connective Tissue Thickness in Carpal Tunnel Syndrome
Official title: Assessment of Subsynovial Connective Tissue Thickness in Carpal Tunnel Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carpal Tunnel Syndrome
Keywords: Carpal Tunnel Syndrome
Subsynovial Connective Tissue
Ultrasound
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2020-07-29
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with and without carpal tunnel syndrome

Brief summary: The general aim of this research is to gain insight in the role of SSCT in the etiology and progression of CTS. We hypothesize that (degenerative) damage of the SSCT occurs early on in the pathogenesis of CTS. Fibrotic damage to the SSCT will lead to altered morphology and biomechanical characteristics. This eventually may lead to damage of the median nerve. To examine the SSCT an ultrasound technique described by Van Doesburg et al. 2012 will be used First, the reliability of the US technique to characterize morphology of the SSCT will be investigated. Secondly, cross-sectional data will be collected in healthy subjects and CTS patients to provide descriptive parameters and to describe differences between patients and controls. In the final part a prospective study will be conducted to look at changes of SSCT thickness over time and after treatment.


Eligibility criteria: Inclusion Criteria:

* For CTS patients
* Human adults, 18 years and older
* Complaints compatible with CTS (Katz Hand Diagram\[31\] rating of 'classic', 'probable' or 'possible' or typical clinical signs)
* Indication for electrodiagnostic testing
* Informed consent to participate
* For Healthy subjects
* Human adults, 18 years and older
* Negative electrodiagnostic testing and scoring 'unlikely' at Katz Hand diagram
* Informed consent to participate

Exclusion Criteria:

* Pregnancy
* History of renal disease, diabetes, chemotherapy, tumors, other neurological diseases (e.g., polyneuropathy), thyroid disease
* Problems of the upper limb, e.g., degenerative and inflammatory joint disease, gout, tendinopathy at the wrist, acute trauma of the upper limb

Primary outcomes:
measure: Inter- and intrarater reliability of subsynovial connective tissue thickness measurement with ultrasound
timeFrame: baseline
measure: Baseline subsynovial connective tissue thickness
timeFrame: Baseline
measure: Change in subsynovial connective tissue thickness after 3, 6 and 12 months
timeFrame: 3, 6, 12 months
measure: Change in subsynovial connective tissue thickness after treatment
timeFrame: 3, 6, 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams Brabant
Study officials:
References:
Clinical trial NCT00000458: Sertraline and Cognitive Therapy in Depressed Alcoholics
Official title: Sertraline and Cognitive Therapy in Depressed Alcoholics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcoholism
Depression
Lead sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Sponsor class: NIH
First posted: 1999-11-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: This study will assess whether individuals treated with sertraline (Zoloft) and cognitive behavior therapy will experience improvement with their depression and consume less alcohol than individuals treated with a placebo and cognitive behavior therapy. This is a 12-week, random assignment, placebo-controlled, double-blind study with followup assessments 1 and 3 months after treatment.


Eligibility criteria: Inclusion Criteria:

* Meets criteria for major depressive episode.
* Meets criteria for alcohol abuse or dependence thirty days prior to entering the study.
* Has had no more than one previous inpatient medical detoxification.
* Able to maintain sobriety for ten days.
* Able to read and understand questionnaires and informed consent.
* Lives within 50 miles of the study site, has a stable living situation, and a reliable source of collateral reporting.

Exclusion Criteria:

* Meets criteria for any other psychoactive substance dependence other than nicotine.
* Any psychoactive substance abuse (other than nicotine or marijuana) within 30 days before beginning of study.
* Meets criteria for other psychiatric disorders including: panic disorder, obsessive-compulsive disorder, bipolar affective disorder, cyclothymia, schizophrenia, any organic mental disorder, eating disorder, dissociative disorder, or post-traumatic stress disorder.
* Has evidence of treatment resistant depression defined as more than one previous treatment episode for depression, which can include hospitalization and/or one course of antidepressant medication.
* Patients may not have been prescribed a specific serotonergic medication within the month prior to study and may not have taken any antidepressant or antipsychotic within the two weeks prior to study.
* Current use of disulfiram (Antabuse) or anti-seizure medications.
* Clinically significant medical problems: cardiovascular, renal, gastrointestinal, or endocrine problems that would limit participation or limit medication ingestion.
* Hepatocellular disease.
* Females who are pregnant, nursing, or not using a reliable form of birth control.
* Current charges pending for violent crime (excluding DUI related offenses).
* Previous adverse experience with a serotonin reuptake inhibitor.
* Current homicidal or suicidal ideation.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References:
Clinical trial NCT00398658: Prophylaxis of Acute Post-Traumatic Bacterial Endophthalmitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Endophthalmitis
Prophylaxy of Post Traumatic Endophthalmitis
Bacterial Endophthalmitis
Keywords: Endophthalmitis
Post-traumatic Endophthalmitis
Bacterial Endophthalmitis
Prophylaxis of Endophthalmitis
Intra Ocular Injection of antibiotics
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2006-11-14
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Purpose: To evaluate the efficacy of combined intraocular injection of gentamycin and clindamycin in prevention of acute posttraumatic bacterial endophthalmitis (APBE) following penetrating eye injuries.

Design: Multicenter, randomized, double masked, controlled trial. Participants: Three hundred forty six eyes of 346 patients with penetrating eye injury.

Method: Following primary repair, eyes were randomized to receive a 0.1 ml intracameral or intravitreal injection of 40µg gentamycin and 45µg clindamycin (cases), versus intracameral or intravitreal injection of 0.1ml balanced saline solution (controls). All patients received standard prophylactic antibiotic therapy (systemic, subconjunctival and topical).

Main outcome measures: Occurrence of endophthalmitis within two weeks after primary repair.


Eligibility criteria: Inclusion Criteria:

* All patients with penetrating eye injuries referred to collaborating institutes for primary repair

Exclusion Criteria:

* Absence of light perception
* presence of endophthalmitis at the time of initial evaluation
* total corneal opacity
* age under 3 years
* severe intracameral hemorrhage
* history of intraocular surgery and presence of a corneal ulcer
* Monocular patients
* the better eye in simultaneous bilateral injuries

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Ophthalmic Research Center
Study officials:
affiliation: Ophthalmic Research Center of Shaheed Beheshti Medical University
name: Masoud Soheilian, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Soheilian M, Rafati N, Mohebbi MR, Yazdani S, Habibabadi HF, Feghhi M, Shahriary HA, Eslamipour J, Piri N, Peyman GA; Traumatic Endophthalmitis Trial Research Group. Prophylaxis of acute posttraumatic bacterial endophthalmitis: a multicenter, randomized clinical trial of intraocular antibiotic injection, report 2. Arch Ophthalmol. 2007 Apr;125(4):460-5. doi: 10.1001/archopht.125.4.460.