louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02779244: Early Weight Bearing for Unstable Ankle Fractures Undergoing Operative Stabilization
Official title: Early Weight Bearing for Unstable Ankle Fractures Undergoing Operative Stabilization: Is It Safe and Does It Improve Outcomes?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Fracture
Keywords: Orthopedic
Post-operative
Weight bearing
Range of motion
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-05-20
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this randomized, controlled trial is to estimate the safety of early weight bearing on post ankle surgery.

Patients who are indicated to have surgery for unstable ankle fractures by an attending trauma physician will be consented for participation in the study. After surgery patients will be randomized to either weight bearing as tolerated at two weeks with a cam boot or non-weight bearing with a cam boot. Randomization will be performed by number allocation with odd numbers in the early weight bearing group and even numbers in the non-weight bearing group. The surgeon will be blinded to this until after the surgery. The patients will all be placed in a short leg cast post operative and made non-weight bearing for 2 weeks until sutures are removed which is current standard treatment. Both groups will be asked to initiate weight bearing at two weeks post operatively by wearing a cam boot that is non weight bearing in a cam boot, the latter being standard treatment.


Eligibility criteria: Inclusion Criteria:

* Operative unstable ankle fractures

Exclusion Criteria:

* Requirement of syndesmotic fixation
* Pilon fractures
* Open fractures
* Patients with diabetic neuropathy
* BMI\>40
* Polytrauma patients
* Patients who are unable to comply with non-weight bearing
* Patients who are unable to follow up

Primary outcomes:
measure: Olerud Molander Ankle Score
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University Langone Medical Center
state: New York
Study officials:
affiliation: NYU Langone Health
name: Nirmal Tejwan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04695444: Effect of Different Nasotracheal Tubes on Tube Passage
Official title: Comparison of the Effect of Tube Type and Intubation Technique on Nasopharyngeal Passage During Nasotracheal Intubation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sialolithiasis
Keywords: nasotracheal intubation
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 150
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to find out the clinical effects that can be obtained during nasotracheal intubation when using velvet-soft PVC tube compared to conventional polyvinylchloride(=PVC) tube.

Detailed description: The hypothesis of this study is that the velvet-soft PVC tube can advanced from the nasal cavity to the oral cavity through the posterior wall of the pharynx more smoothly than conventional PVC tube, thus reducing blockade of tube advancement, nasal/pharyngeal mucosal bleeding, and intubation time. In addition, investigators would like to compare the technique of nasal intubation using by connecting rubber suction catheter to PVC tube tip.

Eligibility criteria: Inclusion Criteria:

* The patients who need to nasotracheal intubation for surgery
* age: 19 years old or more

Exclusion Criteria:

* patient refusal
* nasal deformity
* history of previous moderate degree of epistaxis

Primary outcomes:
measure: blockade of tube advancement from the nasal cavity to the oral cavity [ during intubation]
timeFrame: During nasotracheal intubation (From the time of insertion of the tube through the nostril to completion of the intubation )
Secondary outcomes:
measure: Intubation time
timeFrame: During nasotracheal intubation (From the time of insertion of the tube or tube combined with the rubber suction catheter to the completion of nasotracheal intubation)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
Study officials:
affiliation: Gangnam Severance Hospital
name: Chul Ho Chnag
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim H, Lee JM, Lee J, Hwang JY, Chang JE, No HJ, Won D, Row HS, Min SW. Effect of neck extension on the advancement of tracheal tubes from the nasal cavity to the oropharynx in nasotracheal intubation: a randomized controlled trial. BMC Anesthesiol. 2019 Aug 17;19(1):158. doi: 10.1186/s12871-019-0831-6.
Clinical trial NCT01588444: Ridge Preservation After Tooth Extraction Using Cortical Versus Cancellous Freeze Dried Bone Allograft
Official title: Histological Comparison of Healing Following Tooth Extraction With Ridge Preservation Using Cortical Versus Cancellous Freeze Dried Bone Allograft
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Extraction
Keywords: tooth extraction
bone grafting
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2012-05-01
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare cortical and cancellous freeze-dried bone allograft (FDBA) materials in the preservation of alveolar bone following extraction of non-molar teeth. The primary objective is to histologically evaluate and compare the healing of extraction sockets of non-molar teeth grafted with cortical FDBA versus cancellous FDBA for ridge preservation.


Eligibility criteria: Inclusion Criteria:

* single rooted tooth requiring extraction with future dental implant placement

Exclusion Criteria:

* smoking \> 10 cigarettes per day poorly controlled diabetes

Primary outcomes:
measure: Histologic Percentage of Vital Bone Formation
timeFrame: 18-20 weeks after grafting
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: UT Health Science Center Dental School
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Brian L Mealey, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eskow AJ, Mealey BL. Evaluation of healing following tooth extraction with ridge preservation using cortical versus cancellous freeze-dried bone allograft. J Periodontol. 2014 Apr;85(4):514-24. doi: 10.1902/jop.2013.130178. Epub 2013 May 31.
Clinical trial NCT00205244: Preoperative Preparation for Children
Official title: Preoperative Preparation for Children: Use of Relaxation and Distraction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elective Surgery
Anxiety
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-20
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Children scheduled for elective surgery are randomized into a control and intervention group. Children in the intervention group receive a CD and booklet of relaxation and distraction stories to listen to/read during the preoperative period. Preoperative anxiety is assessed by the child life specialist in the preoperative holding area. Ease of induction and emergence from anesthesia are rated by the anesthesia care provider. Post-hospital behaviors are reported by the parents one week after discharge. It is hypothesized that children receiving the intervention will have less anxiety, easier induction and emergence from anesthesia, and fewer changes in post-hospital behaviors than children in the control group.


Eligibility criteria: Inclusion Criteria:

* Children between 4-12 years of age scheduled for elective surgery

Exclusion Criteria:

* Children \< 4 years of age or \> 12 years of age

Primary outcomes:
measure: do children who receive the intervention have less anxiety, easier induction and emergence from anesthesia
Secondary outcomes:
measure: do children who receive the intervention have fewer changes in post-hospital behaviors
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Joel R Wish
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00120744: Oral Disintegrating Ondansetron Tablet to Reduce Vomiting From Gastroenteritis in a Pediatric Emergency Department
Official title: Randomized Trial of the Oral Disintegrating Ondansetron Tablet to Reduce Vomiting From Acute Gastroenteritis in a Pediatric Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroenteritis
Vomiting
Diarrhea
Dehydration
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: National Center for Research Resources (NCRR)
name: GlaxoSmithKline
name: Ann & Robert H Lurie Children's Hospital of Chicago
First posted: 2005-07-19
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objectives of the study were to determine whether ondansetron treatment would reduce:

* the amount of vomiting in the emergency department;
* the need for intravenous rehydration; and
* the need for hospitalization.

Detailed description: Background:

Vomiting may limit the success of oral rehydration in children with gastroenteritis and dehydration. Limited data suggest that while oral ondansetron may reduce vomiting from gastroenteritis, emergency department revisits may increase.

Methods:

The investigators conducted a prospective, double-blind randomized trial at a pediatric emergency department in 214 dehydrated children, aged 6 months to 10 years with gastroenteritis and mild to moderate dehydration as assessed by a dehydration score. They were randomly assigned to receive treatment with an ondansetron oral disintegrating tablet or placebo. Oral rehydration was administered according to a standard protocol. The primary outcome was the proportion of children who vomited during oral rehydration therapy. The secondary outcomes were the mean number of episodes of vomiting, and the proportion of children treated with intravenous rehydration or hospitalized.

Eligibility criteria: Inclusion Criteria:

* Acute gastroenteritis
* Non-bilious and non-bloody vomiting within 4 hours of triage
* Diarrhea
* Mild to moderate dehydration

Exclusion Criteria:

* Weight less than 8 kilograms
* Severe dehydration
* Underlying disease which might affect the assessment of hydration status (e.g., chronic renal failure, hypoalbuminemia, congestive heart failure, on diuretics)
* History of abdominal surgery
* Hypersensitivity to the drug or any components in its formulation

Primary outcomes:
measure: The proportion of children who vomit during oral rehydration therapy after receiving either 0.13-0.27 mg per kilogram of an oral disintegrating ondansetron tablet or placebo.
Secondary outcomes:
measure: To compare in each treatment arm: mean number of episodes of vomiting, the proportion of children administered supplemental intravenous rehydration or requiring hospitalization.
Other outcomes:
Locations:
Study officials:
affiliation: The Hospital for Sick Children
name: Stephen B Freedman, MDCM, MSCI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04241744: Prospective Trial of Oral Vancomycin Therapy vs. Placebo for Prevention of CDI
Official title: Prospective, Randomized, Double-Blind, Trial of Oral Vancomycin Therapy Compared to Placebo As Primary Prevention for C. Difficile-associated Infection (CDI)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: CDI
Lead sponsor: Creighton University
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this research study is to determine in patients receiving intravenous (IV) antibiotic(s), if giving oral vancomycin therapy will prevent C. difficile-associated infection (commonly called CDI). Oral vancomycin is an antibiotic that is commonly used to treat CDI. The investigators want to study if using this drug can prevent the development of CDI while you are in the hospital receiving IV antibiotics. The key risk factors for developing CDI are age and IV antibiotic therapy. CDI is an infection in your colon caused by an organism called Clostridium difficile (or C. diff for short) that causes diarrhea. Up to 12% of hospital-acquired infections have been reported to be CDI. It can lead to longer hospital stays and more costs associated with the hospital stay.


Eligibility criteria: Inclusion Criteria:

* 1. Older patients (\> 65 years of age), hospitalized for \> 48 hours and treated with parenteral antimicrobial therapy for \> 48 hours at CHI Creighton University Medical Center-Bergan Mercy will be eligible for enrollment.

Exclusion Criteria:

1. Patients diagnosed with CDI within the first 72 hours of hospitalization and/or diagnosed with CDI within the past 3 months
2. Patients diagnosed with gastrointestinal infection other than CDI
3. Patients who have received a solid-organ transplant in the past 12 months
4. Females who are pregnant or immediately post-partum
5. Patients admitted to the hospital with an opportunistic infection secondary to HIV-1 and CD4 cell count of \< 200 cell/mm3
6. Patients receiving cancer chemotherapy or immune modulator drugs (i.e. Checkpoint inhibitors; PD-1/PD-L1 inhibitors; biologic DMARDs) as examples
7. Patients being treated with ≥ 28 days of intravenous (IV) antimicrobials (complex S. aureus bacteremia, osteomyelitis, endocarditis)

Primary outcomes:
measure: number of enrolled patients who develop CDI during hospitalization assessed ("up to 3 month")
timeFrame: during hospitalization through study completion, assessed up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University Medical Center - Bergan Mercy
state: Nebraska
Study officials:
References:
Clinical trial NCT00398944: Impact of a Computerized Guidelines on the Management of Hypertension and Diabetes
Official title: Impact of a Computerized Decision Support System, Based on EBM French Guidelines, on the Management of Hypertension and Diabetes: a Randomised Controlled Trial in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Hypertension
Keywords: Guideline based decision support system, Hypertension, Diabetes
Lead sponsor: Société de Formation Thérapeutique du Généraliste
Sponsor class: OTHER
First posted: 2006-11-14
Enrollment: 2715
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose is to determine wether an electronic decision support system based on national guidelines is effective to improve the follow-up and the treatment of two conditions: hypertension and diabetes, in primary care practices.

Detailed description: Existing computer-based ordering systems for physicians provide drug-centred checks but offer little assistance for optimizing the overall patient-centred treatment strategy.

The ASTI project aims :

1. to design a guideline-based decision support system for diabetic and/or hypertensive patients, to help general practitioners :

   1. to carry out procedures (clinical and biological tests) according to guidelines (the recommended procedure at the recommended moment), and to get a synthetic view of all the elements they need to follow-up the patient
   2. to avoid prescription errors and to improve compliance with therapeutic guidelines. The " critic mode " operates as a background process and corrects the physician's prescription on the basis of automatically triggered elementary rules that account for isolated guideline recommendations. The " guided mode " directs the physician to the best treatment by browsing a comprehensive guideline knowledge base represented as a decision tree.
2. To measure the impact of ASTI when it is implemented with an electronic medical record system. We adopt a randomized design, with the practice as the unit of randomization.

Eligibility criteria: Inclusion Criteria:

* Hypertension
* Mellitus diabetes
* Follow-up by GP's

Primary outcomes:
measure: Patients who underwent the recommended procedures during the last 12 months
timeFrame: 16 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: SFTG
Study officials:
affiliation: Société de Formation Thérapeutique du Généraliste
name: Hector FALCOFF
role: PRINCIPAL_INVESTIGATOR
References:
citation: Seroussi B, Bouaud J, Dreau H, Falcoff H, Riou C, Joubert M, Simon C, Simon G, Venot A. ASTI: a guideline-based drug-ordering system for primary care. Stud Health Technol Inform. 2001;84(Pt 1):528-32.
Clinical trial NCT00812344: Effect of Ketoconazole on Biliary Excretion of AZD0837
Official title: An Open, Randomised, Cross-over, Single Centre Pharmacokinetic (Phase I) Study of the Biliary Excretion Following Single Doses of AZD0837, Given in the Duodenum Via a Loc-I-Gut Catheter, Alone or in Combination With Ketoconazole (Once Daily for 4 Days), to Young Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: pharmacokinetics
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-12-22
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This is an explorative study and the scientific question to be investigated is if the biliary excretion of AZD0837 and its metabolites AR-H069927XX and AR-H067637XX are affected by co-administration with ketoconazole


Eligibility criteria: Inclusion Criteria:

* body mass index (BMI) between 19 to 30 kg/m2 and body weight between 50 to 100 kg inclusive

Exclusion Criteria:

* Significant illness, trauma or surgical procedures.
* Clinically significant laboratory abnormalities.
* Clinically significant medical history

Primary outcomes:
measure: Amount of AZD0837, AR-H069927XX, and AR-H067637XX in bile and biliary clearance of AZD0837, AR-H069927XX, and AR-H067637XX.
timeFrame: Frequent sampling through a Loc-I-Gut catheter for up to 3 hours post dose.
Secondary outcomes:
measure: PK variables of AZD0837, AR-H069927XX, and AR-H067637XX.
timeFrame: Frequent sampling during 24 hours.
measure: Adverse events, physical examination, safety laboratory variables, blood pressure, pulse and electrocardiography.
timeFrame: Some of the safety variables will be followed at each visit, some less frequent.
measure: Pharmacogenetics
timeFrame: One sampling during the study.
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Research Site
Study officials:
affiliation: Inst för Kirurgiska VetenskaperUppsala Universitet
name: Lars Knutson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02359344: PK & Tolerability of CNV1014802 in Young and Elderly Healthy Volunteers
Official title: A Randomized, Double-blind, Placebo Controlled, Two Period Crossover Study to Investigate the Pharmacokinetics, Tolerability and Cognitive Effects of an Oral Dose Regimen of 150mg Tid CNV1014802 in Healthy Young Versus Elderly Male and Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Trigeminal Neuralgia
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2015-02-10
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A randomized, double-blind, placebo controlled, two period crossover study to investigate the pharmacokinetics, tolerability and cognitive effects of 8 days dosing of CNV1014802 in healthy young versus elderly male and female subjects. Treatment periods will be separated by 13 days. The primary outcome measures are pharmacokinetics (PK) and tolerability.

Detailed description: This study was previously posted by Convergence Pharmaceuticals, Ltd., which has been acquired by Biogen.

Eligibility criteria: Key Inclusion Criteria:

* Healthy male and female over 18 years using acceptable methods of contraception

Key Exclusion Criteria:

* Positive pre-study HIV, Hepatitis B surface antigen or positive Hepatitis C antibody
* History or evidence of alcohol or drug abuse
* Pregnant or lactating females
* Participation in a clinical trial within 3 months or the current study or exposure to more than four new chemical entities within 12 months.
* Use of prohibited concomitant medication
* History or presence of any clinically significant abnormality in vital signs / ECG / laboratory tests, or have any medical or psychiatric condition, which, in the opinion of the Investigator may interfere with the study procedures or compromise subject safety.
* Relevant history of a suicide attempt or suicidal behavior

Note: Other protocol defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Maximum Concentration
timeFrame: 9 days
measure: Area under the concentration curve
timeFrame: 9 days
measure: Minimum concentration
timeFrame: 9 days
measure: Frequency of adverse events
timeFrame: 9 days
measure: Change in vital signs compared to baseline
timeFrame: 9 days
measure: Change in 12-lead ECG parameters compared to baseline
timeFrame: 9 days
measure: Change in safety lab parameters compared to baseline
timeFrame: 9 days
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Parexel International
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: