louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03395821: Traditional Versus Virtual Reality for Surgical Skills for ObGyn Residents
Official title: Comparison Between Exclusive Surgical Training Versus Virtual Reality Plus Traditional Training in Surgical Skills of Residents of Obstetrics and Gynecology
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gynecologic Disease
Keywords: competency-based education
gynecology
laparoscopy
resident education
simulation
surgical curriculum
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2018-01-10
Enrollment: 24
Sex: ALL
Minimum age (years): 24
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups will be compared according to their surgical skills.
Primary purpose: OTHER

Brief summary: This study will verify if a comprehensive laparoscopic curriculum using virtual reality demonstrates skills transfer to the operating room, compared to the traditional teaching method.

Detailed description: Second-year residents from different programs of residency in obstetrics and gynecology in Porto Alegre, RS, Brazil, will be invited to participate in this study. they will be randomized to receive a comprehensive training in laparoscopy using modern virtual reality program or the traditional method of training according to their residency program. After 12 weeks of training, they will finish their training and they will perform advanced laparoscopic surgery in the simulator according to their specific needs, for example, salpingectomy, oophorectomy advanced laparoscopic suture or hysterectomy. Data generated from the simulator program will be compared between groups.

Eligibility criteria: Inclusion Criteria:

* residents in obstetrics and gynecology that are about to finish their second-year program

Exclusion Criteria:

* refuse to participate

Primary outcomes:
measure: Efficiency of technical skills (%)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: HCPA
state: RS
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Leandro T Cavazzola, MD,PhD
role: STUDY_CHAIR
References:
citation: Shirai Y, Yoshida T, Shiraishi R, Okamoto T, Nakamura H, Harada T, Nishikawa J, Sakaida I. Prospective randomized study on the use of a computer-based endoscopic simulator for training in esophagogastroduodenoscopy. J Gastroenterol Hepatol. 2008 Jul;23(7 Pt 1):1046-50. doi: 10.1111/j.1440-1746.2008.05457.x. Epub 2008 Jun 28.
citation: Palter VN, Grantcharov TP. Individualized deliberate practice on a virtual reality simulator improves technical performance of surgical novices in the operating room: a randomized controlled trial. Ann Surg. 2014 Mar;259(3):443-8. doi: 10.1097/SLA.0000000000000254.
citation: Shore EM, Grantcharov TP, Husslein H, Shirreff L, Dedy NJ, McDermott CD, Lefebvre GG. Validating a standardized laparoscopy curriculum for gynecology residents: a randomized controlled trial. Am J Obstet Gynecol. 2016 Aug;215(2):204.e1-204.e11. doi: 10.1016/j.ajog.2016.04.037. Epub 2016 Apr 27.
Clinical trial NCT04455321: The Effect of Suture Materials With Different Absorption Times on Isthmocele: Prospective Randomized Study
Official title: The Effect of Suture Materials With Different Absorption Times on Isthmocele: Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suture, Complication
Istmocel
Keywords: rapid
suture material
istmocel
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2020-07-02
Enrollment: 102
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Rapid vicryl will used in study group and vicryl will used in control group for uterine closure in cesarean section.
Primary purpose: PREVENTION

Brief summary: This study aims to investigate the effect of suture materials with different absorption times on istmocel.


Eligibility criteria: Inclusion Criteria:

* primary cesarean section
* single pregnancy
* 18-45 age

Exclusion Criteria:

* Diabetes mellitus disease
* inflammatory bowel disease
* systemic lupus erythematosus disease
* rheumatoid arthritis disease
* previous uterine surgery

Primary outcomes:
measure: Istmocel
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Baskent University Adana Dr. Turgut Noyan Hospital
Study officials:
References:
Clinical trial NCT01148121: Assessment of Bone Density and Bone Turnover Markers in Patients With Down Syndrome and Comparison to the Ts65Dn Model
Official title: Assessment of Bone Density and Bone Turnover Markers in Patients With Down Syndrome and Comparison to the Ts65Dn Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Down Syndrome
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2010-06-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This study may provide information that may serve as the foundation for a larger research study to address issues regarding the causes, diagnosis, and treatment of osteoporosis in the Down syndrome patient population.

Detailed description: Osteoporosis is responsible for more than 1.5 million fractures and $14 billion in medical care costs annually (U.S Dept of Health and Human Services data, 2006). Down syndrome is an independent risk factor for osteopenia/osteoporosis. Increases in life expectancy as well as costly morbidity following fracture are reasons for further investigation of osteoporosis and prevention in this population. Etiology for low bone density is presently unknown in this population but may be related to unique genes on chromosome 21 which alter the biochemistry of bone metabolism or change the gonadal, thyroid and parathyroid function to alter bone formation and/or resorption. There are no published data on the measurement of bone turnover markers in the Down syndrome population; therefore we will measure and accrue this information and compare to our Ts65Dn data, as described later in this protocol.

This pilot study will serve as the foundation for a larger translational research grant which will address multiple issues regarding the pathogenesis, diagnosis and treatment of osteoporosis in the Down syndrome patient population and the Down syndrome mouse model (Ts65Dn). The data has the potential to improve our fundamental understanding of osteoporosis pathogenesis and treatment in the Down syndrome patient with potential applications to treatment in the general population.

Eligibility criteria: Inclusion Criteria:

* Males and Females of all races and ethnicities
* Age 18 or older and current clinical diagnosis of Down Syndrome

Exclusion Criteria:

* No legally authorized representative (if applicable) willing to provide informed consent. Any condition the investigator determines will put the subject at risk by participating in the study.

Primary outcomes:
measure: Ts65DN pathogenesis proxy
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Kent D McKelvey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00889421: Apremilast in the Treatment of Uveitis
Official title: An Open-label Trial to Assess the Efficacy and Safety of Apremilast in the Management of Vision-threatening Uveitis That is Refractory to Other Modes of Systemic Immunosuppression.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Uveitis
Keywords: uveitis
apremilast
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Celgene Corporation
First posted: 2009-04-28
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and efficacy of Apremilast in the treatment of uveitis.


Eligibility criteria: Inclusion Criteria:

* patients with vision-threatening autoimmune uveitis
* failure to respond to prednisone and at least one other systemic immunosuppressive, or intolerance to such medications due to side effects

Exclusion Criteria:

* serious concomitant illness that could interfere with the subject's participation
* previous or current use of an alkylating agent
* use of CYP3A4 inhibitors during the trial
* TNF blocker use within the 8 weeks prior to enrollment

Primary outcomes:
measure: Improvement by 2 or More Lines of Best-corrected Snellen Visual Acuity in at Least One Eye
timeFrame: 6 months
measure: Reduction in Dose of Systemic Corticosteroid or Other Immunosuppressive Therapy by at Least 50%
timeFrame: 6 months
measure: Control of Ocular Inflammation, as Judged on Clinical Criteria, According to Standard Methods (Reduction of Anterior Chamber Cellular Activity and/or Chorioretinal Infiltrates and/or Retinal Vasculitis)
timeFrame: 6 months
measure: Reduction in Cystoid Macular Edema
timeFrame: 6 months
Secondary outcomes:
measure: Type, Frequency, Severity, and Relationship of Adverse Events to Study Treatment
timeFrame: 7 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Eric B Suhler, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00057421: Tuberculosis in HIV Infected Patients in Uganda
Official title: Impact of Tuberculosis on HIV Infection in Uganda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tuberculosis
HIV Infections
Keywords: Tuberculosis
HIV infection
Prednisolone
Safety
Immune activation
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2003-04-03
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This was a clinical trial in HIV infected patients with tuberculosis. The study assessed whether the addition of prednisolone, a type of steroid medication, to the standard treatment for tuberculosis improved immune and viral outcomes in the patients. The study demonstrated that prednisolone increased the CD4 cell count as was hoped, but the beneficial effect was short-lived and was gone within 4 months of stopping therapy. Therefore, the use of prednisolone for tuberculosis in HIV infected patients is not recommended at this time.

Detailed description: Recent observations from retrospective cohort studies indicate that HIV-associated tuberculosis (TB) is associated with reduced survival and increased rate of opportunistic infections compared to CD4-matched controls. Mounting evidence from immunologic and virologic studies supports the concept of co-pathogenesis, in which cytokines such as tumor necrosis factor alpha (TNF alpha) are over-expressed during the course of TB and stimulate viral replication in latently infected cells, possibly leading to greater viral load.

Glucocorticoids are potent inhibitors of cytokines, including TNF, and clinicians have extensive experiences with their use in HIV infection. Although corticosteroid use in HIV infection has a record of safety, the safety and bioavailability of corticosteroids in HIV/TB coinfection has not been established.

This study evaluated the change in viral load and CD4 count in HIV infected patients with TB who were treated with oral prednisolone. The study found that the viral load increased slightly when prednisolone was administered and that patients receiving prednisolone cleared their tuberculosis more rapidly. Although there was some benefit to using prednisolone in these patients, the benefit was short-lived and was gone within 4 months of stopping therapy.

Eligibility criteria: Inclusion Criteria

* Pulmonary TB (smear positive)
* HIV infected
* Residence within 20 km of Kampala city
* Allows frequent blood specimens to be drawn

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Mulago Hospital Tuberculosis Clinic
Study officials:
affiliation: Case Western Reserve University
name: Christopher Whalen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04595721: Comparison of Physical Versus Visual Distraction in the Reduction of Pain During Local Anesthesia
Official title: Comparison of Physical Versus Visual Distraction in the Reduction of Pain During Local Anesthesia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pain
Keywords: Dental pain
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2020-10-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to compare physical versus visual distractions to determine which technique reduces perceived pain better during local anesthesia injections.

Detailed description: Before the local anesthesia injection, patients will be asked to give a preliminary VAS score based on what level of pain 0-10 they anticipate they will feel during the local anesthesia injection. Following the injection the participant will be asked to quantify the pain felt during the injection on a 0-10 Visual analog scale (VAS). The VAS scores will only be taken from the first injection of the appointment. Participants will be asked their gender, race, age, geographic location they spent most of their lives as well. Participants will be de-identified and randomly assigned a number that will be recorded along with their collected data on a two-factor, password protected web server. Information collected during this study may be used for further analysis and publication.

Eligibility criteria: Inclusion Criteria:

* Patients needing a dental procedure that requires a buccal infiltration with Septocaine 1:100,000 epinephrine (EPI) (Articaine hydrochloride 4% and EPI 1:100,000) or an inferior alveolar nerve block injection with 2% lidocaine with 1:100,000 epinephrine.
* Adults greater than 18 years old.
* Patients with limited English proficiency will be included only if their primary language is Spanish.

Exclusion Criteria:

* Patients with a known or suspected allergy to anesthetic agent, sulfites, amide-type local anesthetic, or to any ingredient in anesthetic solutions will not be included.
* Any patients taking medications affecting pain response on the day of the dental appointment.
* Children younger than 18 years old.
* Patients with limited English proficiency with a primary language other than Spanish

Primary outcomes:
measure: Change in pain
timeFrame: Up to 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Virginia Commonwealth University
name: Louis Formica, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01902121: Compare the Same Dosage of Insulin Using a Combination of Cartridges, 30 Units as 2 Cartridges vs. 1 Cartridge
Official title: A Phase 1, Open-label, Randomized, Crossover Clinical Trial in Healthy Normal Volunteers to Evaluate the Bioequivalence of 30 U TI Inhalation Powder Delivered by Gen2 Inhaler Using One 30 U Cartridge Versus a Combination of 10 U and 20 U Cartridges
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Mannkind Corporation
Sponsor class: INDUSTRY
First posted: 2013-07-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A Phase 1, open-label, randomized, crossover study in 36 healthy normal volunteers (HNVs) to evaluate the bioequivalence of TI Inhalation Powder delivered using the Gen2 Inhaler and administered as one 30 U cartridge versus a combination of one 10 U cartridge and one 20 U cartridge.


Eligibility criteria: Inclusion Criteria:

* Men and women aged 18 to 45 years, considered healthy based on screening physical examination, medical history, clinical chemistry, and urinalysis
* No smoking in the past 6 months (including cigarettes, cigars, and pipes)
* Urine cotinine testing \< 100 ng/mL
* Body mass index \< 32 kg/m2
* Completion of informed consent form

Exclusion Criteria:

* FBG \> 100 mg/dL
* Clinically significant active or chronic illness
* History of asthma, chronic obstructive pulmonary disease (COPD), or any other clinically relevant chronic lung disease
* Respiratory tract infection within 4 weeks before screening and between the screening visit and dosing visit
* Subjects who are experiencing persistent or recurring cough, wheezing, bronchospasm, or dyspnea

Primary outcomes:
measure: Area-under-the-serum insulin concentration versus time curve (AUC0-240min
timeFrame: 0, 5, 10, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 210 and 240 minutes post-TI dosing
Secondary outcomes:
Other outcomes:
Locations:
city: Neptune
country: United States
state: New Jersey
Study officials:
References:
Clinical trial NCT02883621: The Diagnostic Yield of Cap Assisted Upper Endoscopy in Esophagus
Official title: Comparison Between Standard Endoscopy and Cap Assisted Endoscopy for Diagnostic Yield in Esophagus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endoscopic Diagnosis in Esophagus
Keywords: upper endoscopy
cap assisted endoscopy
esophagus
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: Klinikum Freising
name: Klinikum Landshut-Achdorf
name: Städtisches Klinikum Neuperlach
name: Rotkreuzklinikum München gGmbH
name: Gemeinschaftspraxis Dr. Schatke & Dr. Ott
name: Gastroenterologische Fachpraxis Abdomen Prof. Dr. Manfred Kurjak
First posted: 2016-08-30
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Cap assisted colonoscopy, a simple technique of fixing a transparent plastic cap to the tip of the colonoscope, was proven to increase the adenoma detection rate during screening colonoscopy by helping to depress and flatten colonic folds, thereby improving visualization and decreasing blind mucosal areas. The usefulness of cap assisted upper endoscopy (CAE) is still under investigations. The aim of this study is to compare the diagnostic yield of the CAE to the standard endoscopy in esophagus.


Eligibility criteria: Inclusion Criteria:

* indication for upper endoscopy
* age over 18 years
* ability to provide informed consent

Exclusion Criteria:

* known or suspected upper gastrointestinal strictures
* upper gastrointestinal bleeding
* previous upper endoscopy during the last three months
* American Society of Anesthesiologists class III or higher

Primary outcomes:
measure: Diagnostic yield in esophagus
timeFrame: 15 Minutes
Secondary outcomes:
measure: Overall diagnostic yield in upper gastrointestinal tract.
timeFrame: 15 Minutes
Other outcomes:
Locations:
city: Munich
country: Germany
facility: II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München
state: Bayern
Study officials:
affiliation: II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München
name: Mohamed Abdelhafez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02725021: Education Against Tobacco Randomized Trial in Brazil
Official title: Education Against Tobacco: Medical-student-delivered Smoking Prevention Programme for Secondary Schools in Brazil - Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tobacco Prevention
Keywords: tobacco prevention
Lead sponsor: University of Giessen
Sponsor class: OTHER
First posted: 2016-03-31
Enrollment: 1500
Sex: ALL
Minimum age (years): 5
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A two armed randomized trial is evaluating the effect of the medical-student-delivered school-based intervention Education Against Tobacco on the smoking behavior of adolescents in 7-11th grade of secondary school. The primary endpoint is the change in smoking prevalence between the two groups.


Eligibility criteria: Inclusion Criteria:

* Visiting grades 7-11 of a regular public secondary school in Brazil.

Exclusion Criteria:

* Not fulfilling inclusion criteria.

Primary outcomes:
measure: Smoking prevalence measured via questionnaire.
timeFrame: 12 months follow-up
Secondary outcomes:
measure: Smoking onset: Difference in the number of new smokers at 12 months of follow-up who were not present at baseline
timeFrame: Baseline and 12 months
measure: Difference in the number of new non-smokers at 12 months of follow-up who were smoking at baseline
timeFrame: Baseline and 12 months
measure: Relevant differences due to the theory of planned behaviour between the two groups measured via questionnaire.
timeFrame: Difference in attitude towards smoking between the two groups at 12 months follow-up measured via questionnaires.
Other outcomes:
Locations:
Study officials:
References:
citation: Lisboa OC, Bernardes-Souza B, Xavier LEF, Almeida MR, Correa PCRP, Brinker TJ. A Smoking Prevention Program Delivered by Medical Students to Secondary Schools in Brazil Called "Education Against Tobacco": Randomized Controlled Trial. J Med Internet Res. 2019 Feb 21;21(2):e12854. doi: 10.2196/12854.
citation: Xavier LE, Bernardes-Souza B, Lisboa OC, Seeger W, Groneberg DA, Tran TA, Fries FN, Correa PC, Brinker TJ. A Medical Student-Delivered Smoking Prevention Program, Education Against Tobacco, for Secondary Schools in Brazil: Study Protocol for a Randomized Trial. JMIR Res Protoc. 2017 Jan 30;6(1):e16. doi: 10.2196/resprot.7134.