louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05437172: Evaluation of Autogenous Demineralized Dentin Graft for Ridge Preservation With and Without Injectable Platelet Rich Fibrin
Official title: Clinical and Radiographic Evaluation of Autogenous Demineralized Dentin Graft for Ridge Preservation With and Without Injectable Platelet Rich Fibrin (A Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ridge Preservation
Alveolar Bone Loss
Dentin Graft
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-06-29
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ridge preservation should be considered whenever possible after tooth extraction. Whether implant placement would be performed or for aesthetic consideration at pontic sites when conventional bridge is planned. Ridge preservation aims to maximize the bone formation accompanied with good soft tissue architecture to facilitate implant and prosthetic replacement restoring function, phonetics and aesthetics. the Aim of the study is To evaluate the bucco-lingual ridge width clinically and radiographically, height of buccal and lingual ridges of the socket after application of injectable platelet rich fibrin and autogenous dentin graft.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years need of at least one single rooted tooth extraction.
* Non-restorable teeth.
* Systemically healthy patients.
* Good oral hygiene, Plaque index less than 15%.
* Non-smoker or Smoking ≤ 10 cigarettes/day.
* Cooperative patients able and accept to come for follow up appointments.

Exclusion Criteria:

* Any interim intervention that may have affected any of the outcomes of interest.
* Pregnant and lactation females.
* Smoking ˃ 10 cigarettes/day.
* Patients reporting systemic conditions that may compromise healing or bone metabolism (eg: diabetes).
* Patients with poor oral hygiene.
* Any known allergies.

Primary outcomes:
measure: Radiographic Bucco-lingual ridge width change
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Changes in the height of the socket buccal and lingual ridges.
timeFrame: up to 24 weeks
measure: postoperative pain
timeFrame: immediately after the procedure
measure: Patient satisfaction
timeFrame: immediately after the procedure
measure: Keratinized tissue width
timeFrame: up to 24 weeks
measure: chair time
timeFrame: immediately after the procedure
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Cairo University
state: Manial
Study officials:
affiliation: Master student
name: Odai A Hwafdeh, BDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Lecturer of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University
name: Nesma M Shemais, PhD
role: STUDY_DIRECTOR
affiliation: Professor of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University
name: Mona S Darhous, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01608672: Long-Term Patient Satisfaction of Facial Aesthetic Treatment With BOTOX®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glabellar Lines
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2012-05-31
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects treated for at least 5 years with BOTOX® for glabellar lines

Brief summary: This is an observational study assessing patient satisfaction following at least 5 years of BOTOX® treatment for glabellar lines.


Eligibility criteria: Inclusion Criteria:

* At least one BOTOX® treatment for facial wrinkles (glabellar lines) per calendar year for ≥5 years

Exclusion Criteria:

* Received botulinum toxin formulations other than BOTOX®

Primary outcomes:
measure: Percentage of Participants Mostly or Very Satisfied With Their Glabellar Lines on the Facial Line Satisfaction Questionnaire (FLSQ)
timeFrame: Study Day 1 (approximately 4-28 weeks following last treatment)
Secondary outcomes:
measure: Percentage of Participants Mostly or Very Satisfied With Effectiveness of ≥ 5 Years BOTOX® Treatments Using the Patient Questionnaire
timeFrame: Study Day 1 (approximately 4-28 weeks following last treatment)
measure: Percentage of Participants Where Physician Was Mostly or Very Satisfied With Effectiveness of ≥ 5 Years BOTOX® Treatments Using the Physician Questionnaire
timeFrame: Study Day 1 (approximately 4-28 weeks following last treatment)
Other outcomes:
Locations:
city: Coral Gables
country: United States
state: Florida
city: South Yarra
country: Australia
city: Sao Paolo
country: Brazil
city: Niagara Falls
country: Canada
state: Ontario
city: Cannes
country: France
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Trindade de Almeida A, Carruthers J, Cox SE, Goldman MP, Wheeler S, Gallagher CJ. Patient satisfaction and safety with aesthetic onabotulinumtoxinA after at least 5 years: a retrospective cross-sectional analysis of 4,402 glabellar treatments. Dermatol Surg. 2015 Jan;41 Suppl 1:S19-28. doi: 10.1097/DSS.0000000000000275.
Clinical trial NCT06612372: Effects of 60-day-6° Head-down Bed Rest on Cartilage and Function of the Knee Joint
Official title: Effects of 60-day-6° Head-down Bed Rest on Cartilage and Function of the Knee Joint
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cartilage Degeneration
Weightlessness
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2024-09-25
Enrollment: 26
Sex: MALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Objective: To investigate the effects of long-term simulated unloading in bed on articular cartilage quality based on functional magnetic resonance imaging (FMRI) and Knee joint function.

Detailed description: A total of 26 subjects were recruited for a 60-day period of head-down bed rest (HDBR). The bed rest position is a 6° downward tilt of the head, and all daily activities are performed in this position. We will perform functional MRI scans of the right knee joint using T2 mapping sequences to assess tissue composition and water content before and after HDBR. Functional assessments, including the Y-Balance Test and International Knee Documentation Committee (IKDC) scores, were performed pre-HDBR and post-HDBR.We will divide each participant's knee cartilage into 18 regions and measured T2 values according to the whole organ magnetic resonance imaging score (WORMS) partitioning method.

Eligibility criteria: Inclusion Criteria:

* (1) male; (2) age 25-50 years old; (3) height between 160-175 cm, weight ≥50kg, and BMI between 18.5-26 kg/m²; (4) good general health status.

Exclusion Criteria:

* (1) history of alcoholism; (2) smoking ≥5 cigarettes/day in the 3 months before the test; (3) drug dependence or use of medications affecting bone metabolism within 2 weeks before screening; (4) presence of metal implants, severe vertigo, or severe snoring.

Primary outcomes:
measure: T2 mapping
timeFrame: three days before the HDBR started and three days after the HDBR ended
Secondary outcomes:
measure: Y-balance test
timeFrame: three days before the HDBR started and three days after the HDBR ended
measure: International Knee Documentation Committee (IKDC) scores
timeFrame: three days before the HDBR started and three days after the HDBR ended
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Peking University Third Hospital
name: Jianquan Wang, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT01734772: Investigation of Drug-drug Interaction of Dabigatran and Ticagrelor
Official title: Investigation of Drug-drug Interaction of Dabigatran and Ticagrelor Under Steady State Conditions in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2012-11-28
Enrollment: 48
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To investigate the pharmacokinetic and pharmacodynamic interaction of dabigatran and ticagrelor under steady state conditions; to investigate the effect of staggered administration of ticagrelor loading dose on dabigatran exposure (in Part II)


Eligibility criteria: Inclusion criteria:

1. Healthy male subjects.

Exclusion criteria:

1. Any relevant deviation from healthy conditions.

Primary outcomes:
measure: Total Dabigatran: Area Under the Concentration-time Curve at Steady State Over the Uniform Dosing Interval τ (AUCτ,ss)
timeFrame: 47.55, 48.30,49, 49.30,50,50.30,51,52,54,56, 60 hours
measure: Total Dabigatran: Maximum Measured Concentration at Steady State (Cmax,ss)
timeFrame: 47.55, 48.30,49, 49.30,50,50.30,51,52,54,56, 60 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Biberach
country: Germany
facility: 1160.142.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT01482572: Feasibility of Mutational Analysis of Non-Small Cell Lung Cancer (NSCLC) Using Low-volume Lung Aspirates
Official title: Feasibility of Gene Expression Profiling Using Low-volume Lung Aspirate
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Lung Cancer
Keywords: biopsy
needle aspiration
mutational analysis
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2011-11-30
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: lung cancer patients

Brief summary: The purpose of this study is to evaluate the feasibility of aspiration samples for mutational analysis in patients with a non-small cell lung cancer (NSCLC).

Detailed description: The investigators will compare results of mutational analysis from a core needle biopsy and fine needle aspiration.

Eligibility criteria: Inclusion Criteria:

* primary tumor or a metastatic lung lesion requested for mutational analysis

Exclusion Criteria:

* a) lesions located adjacent to the large central bronchi or vessels
* b) peribronchovascular lesions with prominent internal CT air-bronchograms, which were considered difficult to be avoided by needle pass
* c) lesions in patient with severe respiratory compromise

Primary outcomes:
measure: Success rates for mutation analysis
timeFrame: one year
Secondary outcomes:
measure: Technical success rate of biopsy procedure
timeFrame: one year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Ho Yun Lee, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03103672: Total Intravenous Anesthesia in Percutaneous Transhepatic Cholangiography
Official title: Comparison of Inhalation Anesthesia and Total Intravenous Anesthesia in Percutaneous Transhepatic Cholangiography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Percutaneous Transhepatic Cholangiography
Keywords: quality of anesthesia
reduce recovery time
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2017-04-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing percutaneous transhepatic cholangiography

Brief summary: Percutaneous transhepatic cholangiography is a disturbing procedure for patients.

TIVA with short-acting anesthetics such as propofol and remifentanil is characterized by hemodynamic stability and better compilation profile The purpose of this study; To compare total intravenous anesthesia with inhalation anesthesia in patients undergoing percutaneous transhepatic cholangiography under general anesthesia.

Detailed description: Percutaneous transhepatic cholangiography is a disturbing procedure for patients. Especially pain at the time of dilation can be a serious problem. These situations may be required local anesthetics, intravenous narcotics and sedatives or general anesthesia (1).

TIVA with short-acting anesthetics such as propofol and remifentanil is characterized by hemodynamic stability and better compilation profile (2).

The purpose of this study; To compare total intravenous anesthesia with inhalation anesthesia in patients undergoing percutaneous transhepatic cholangiography under general anesthesia and Determine their advantages and disadvantages.

1. Michael J. Lee, Peter R. Mueller, Sanjay Saini, Peter F. Hahn, Stewen L. Dawson. Percutaneous Dilatation of Benign Biliary Strictures: Single-Season Therapy with General Anesthesia. AJR: 157, December 1991: 1263-1266
2. Xiaoqian Deng, Tao Zhu. Clinical comparison of propofol-remifentanil TCI with sevoflurane induction / maintenance anesthesia in laparoscopic cholecystectomy. Pak J Med Sci 2014 Vol. 30 No. 5: 1017-1021

Eligibility criteria: Inclusion Criteria:

* Adult patients undergoing percutaneous transhepatic cholangiography with general anesthesia

Exclusion Criteria:

* Essential data were missing
* Patient participating in other research projects
* Drug allergy
* Anesthetic complication story

Primary outcomes:
measure: Recovery time from anesthesia
timeFrame: up to postoperative 1 hours
Secondary outcomes:
measure: Heart rate
timeFrame: up to postoperative 1 hours
measure: Mean blood pressure
timeFrame: up to postoperative 1 hours
Other outcomes:
Locations:
Study officials:
affiliation: Department of Anesthesia, İnonu Univercity, School of Medicine
name: Yusuf Z Çolak, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06496672: The Wrist-Free Study - Comparing Traditional Above Elbow Casts to Ones That Free the Wrist
Official title: The Wrist-Free Study- A Randomized Controlled Trial Comparing Traditional Above Elbow Casts to Ones That Free the Wrist in Pediatric Supracondylar Humerus Fractures
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Supracondylar Humerus Fracture
Keywords: Pediatric
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
First posted: 2024-07-11
Enrollment: 76
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial compares clinical outcomes, patient comfort and satisfaction of freeing the wrist in casts for supracondylar humerus fractures in children.


Eligibility criteria: Inclusion Criteria:

* Type I and Type IIa Supracondylar Humerus Fracture

Exclusion Criteria:

* History of elbow injury
* Polytrauma

Primary outcomes:
measure: Patient Satisfaction
timeFrame: 3-4 Weeks
Secondary outcomes:
measure: Complications in healing
timeFrame: 3-4 Weeks
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
affiliation: KK Women's and Children's Hospital
name: Kenneth PL Wong, FRCS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Khoshbin A, Leroux T, Wasserstein D, Wolfstadt J, Law PW, Mahomed N, Wright JG. The epidemiology of paediatric supracondylar fracture fixation: a population-based study. Injury. 2014 Apr;45(4):701-8. doi: 10.1016/j.injury.2013.10.004. Epub 2013 Oct 17.
citation: Micheloni GM, Novi M, Leigheb M, Giorgini A, Porcellini G, Tarallo L. Supracondylar fractures in children: management and treatment. Acta Biomed. 2021 Jul 26;92(S3):e2021015. doi: 10.23750/abm.v92iS3.11725.
citation: Boyd AS, Benjamin HJ, Asplund C. Splints and casts: indications and methods. Am Fam Physician. 2009 Sep 1;80(5):491-9.
citation: Shenoy PM, Islam A, Puri R. Current Management of Paediatric Supracondylar Fractures of the Humerus. Cureus. 2020 May 15;12(5):e8137. doi: 10.7759/cureus.8137.
citation: Vaquero-Picado A, Gonzalez-Moran G, Moraleda L. Management of supracondylar fractures of the humerus in children. EFORT Open Rev. 2018 Oct 1;3(10):526-540. doi: 10.1302/2058-5241.3.170049. eCollection 2018 Oct.
Clinical trial NCT00506272: Inpatient Self Monitoring and Administration Study (ISMAS)
Official title: Inpatient Self Monitoring and Administration Study (ISMAS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus
Hyperglycemia
Hypoglycemia
Keywords: diabetes mellitus
hyperglycemia
hypoglycemia
self care
Lead sponsor: Atlanta VA Medical Center
Sponsor class: FED
First posted: 2007-07-25
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: ISMAS is designed to test the hypothesis that self management of insulin dependent diabetes mellitus by selected patients admitted for elective surgery is more efficacious than standard care with respect to overall glycemic control, attaining finger-stick blood sugars, and administering insulin.


Eligibility criteria: Inclusion criteria:

1. Male or female, age \< 80
2. Most recent hemoglobin A1C within the past 6 months \< 12%
3. Recent history of regular self-administered peripheral blood glucose checks as an outpatient
4. Recent history of insulin self-administration at least twice a day as an outpatient
5. Admitted for a hospitalization anticipated to last at least 3 days
6. Mini Mental Status Examination (MMSE) ≥ 25 at admission and the same or better post-operatively
7. All patients will be actively followed by the Endocrinology inpatient consultation team during the hospitalization.

Exclusion criteria:

1. Currently receiving peritoneal or hemodialysis
2. Patients with unstable angina
3. History of myocardial infarction within 3 weeks prior to enrollment
4. Current admission due to or associated with altered mental status or encephalopathy
5. History of an episode of altered mental status or encephalopathy within the 4 weeks prior to enrollment
6. A confirmed diagnosis of dementia
7. Inability to self-adjust insulin
8. No recent history of ability to perform regular peripheral blood glucose checks
9. Frequency of hypoglycemia (\< 60 mg/dL) \> twice/week by history
10. Inability to eat without assistance
11. Study objectives will not be pursued in patients during stays in any intensive care unit.

Primary outcomes:
measure: number of blood glucose measurements obtained/number of blood glucose measurements ordered
timeFrame: patients will be followed for the duration of hospital stay, an expected average of 5 days
measure: number of insulin doses administered/number of insulin doses prescribed
timeFrame: patients will be followed for the duration of hospital stay, an expected average of 5 days
measure: average blood glucose
timeFrame: patients will be followed for the duration of hospital stay, an expected average of 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Decatur
country: United States
facility: Atlanta VA Medical Center
state: Georgia
Study officials:
affiliation: Atlanta VA Medical Center
name: Peter M Thule, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05873972: Multimodal Model for Efficacy Prediction Cetuximab in Colorectal Cancer Liver Metastasis Patient
Official title: Multimodal Deep Learning Radiomic Nomogram for Evaluation of Response to Cetuximab in Patient With Colorectal Cancer Liver Metastasis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer Liver Metastases
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Establishment and validation of the deep learning model of Cetuximab efficacy in simultaneous RAS wild unresectable CRLM patients

Detailed description: Ras wild unresectable CRLM patients with primary tumor resection followed by Cetuximab in combination with chemotherapy were included in this study. The tumor response was assessed by local MDT group. Based on tumor response, almost 100 CRLM patients were classified into two groups (Clinician drived regimen vs Multi-omics model drived regimen). They will be the prospective cohort to validate our deep learning model for predicting Cetuximab efficacy.

Eligibility criteria: Inclusion Criteria:

1. Age 18-75 years;
2. Histologically proven colorectal adenocarcinoma;
3. Simultaneous liver-limited metastases;
4. Initially unresectable liver metastases determined by a local MDT;
5. Life expectancy of \> 6 months;
6. RAS and BRAF V600E wild-type;
7. ECOG 0-1;
8. Available CT imaging before treatment.

Exclusion Criteria:

1. Previous systemic treatment for metastatic disease;
2. Previous surgery for metastatic disease;
3. Extrahepatic metastases;
4. Unresectable primary tumor;
5. Major cardiovascular events (myocardial infarction, severe/unstable angina, congestive heart failure, CVA) within 12 months before randomisation;
6. Acute or subacute intestinal obstruction;
7. Second primary malignancy within the past 5 years;
8. Drug or alcohol abuse;
9. No legal capacity or limited legal capacity;
10. Uncontrolled hypertension, or unsatisfactory blood pressure control with ≥3 antihypertensive drugs;

Primary outcomes:
measure: response rate
timeFrame: 6 months
Secondary outcomes:
measure: progression free survival
timeFrame: 3 years
measure: overall survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan hosptial, Fudan University
Study officials:
affiliation: Fudan University
name: Jianmin Xu, MD
role: PRINCIPAL_INVESTIGATOR
References: