louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01164631: Pharyngeal Size in Patients With Obstructive Tonsils Under Orthodontic Treatment
Official title: Improvement of Pharyngeal Size in Patients With Obstructive Tonsils Treated With Bioajusta X Orthodontic Appliance - Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sleep Apnea Syndrome
Malocclusion
Keywords: Sleep Apnea Syndrome
Orthodontics
Tonsillectomy
Child
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2010-07-16
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Enlarged tonsils and malocclusion have relationship with sleep disturbance in children. The consequences of these features can include deviation of normal craniofacial growth such that this may result in a facial morphology more suitable to the development of sleep apnea later in life. The aim of this study was to compare the growth redirection, the evolution of respiratory symptoms and the pharyngeal size of snoring children with obstructive tonsils from the waiting list for surgery treated with the Bioajusta X orthodontic appliance.This new protocol of orthodontic treatment promotes maxillary expansion, mandibular advancement and proper tongue positioning on swallowing , that together may be helpful on remodeling the upper airways.

Detailed description: Methods-The study population included 40 children, ranging in age from 6 to 9 years old, who were on the waiting list for adenotonsillectomy at the ENT Department of FMUSP. The patients were randomly divided into two groups and were subsequently compared after a six month interval. The first group included 24 patients who where treated with the Bioajusta X appliance and the second group included 16 patients who served as controls, and,thus, did not received any treatment. Cephalometric analysis was used to assess the growth direction by comparing the relationship of the vertical jaw based upon the angle of the palatal plane with the mandibular plane (ANS-PNS/Go-M).Pharyngeal size was measured using acoustic pharyngometry. The parents filled out a questionnaire with respect to the respiratory symptoms of their children.

Eligibility criteria: Inclusion Criteria:

* Children 6 to 9 years of age with tonsils degree 3 or 4 ,
* Sleep snores and narrow maxilla or class II malocclusion.

Exclusion Criteria:

* Neurological diseases,
* Tooth missing ,
* Previous orthodontic treatment.

Primary outcomes:
measure: Evaluation of the facial growth
timeFrame: six months
Secondary outcomes:
measure: Pharyngeal Size
timeFrame: six month
Other outcomes:
Locations:
Study officials:
affiliation: University of Sao Paulo General Hospital
name: Renata C Di Francesco, Phd
role: STUDY_DIRECTOR
affiliation: University of Sao Paulo
name: Walter R Nunes Jr., Ms
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01943331: Epidemiological Investigation of CRBSI, VAP, CAUTI in Chinese ICU
Official title: Colonization and Infection in Critically Ill Patients: a Multicenter, Prospective, Observational Study in Intensive Care Units (ICUs) in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nosocomial Infection
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2013-09-16
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted into ICU are eligible for this study. All the infected patients were treated by the attending physician, and the choice and adjustment of antibiotic were in accordance with the recommendations of ATS guidelines.

Brief summary: The current protocol desires to implement a large-multicenter observational study of hospital acquired infection in ICU in China. The study will generate data on generate data about the epidemiology current management of nosocomial infection.

Detailed description: The objectives are as followings:

1. Obtain incidence of three major nosocomial infection in ICU, catheter related blood stream infection(CRBSI), catheter related urinary tract infection (CRUTI), and ventilator associated pneumonia (VAP).
2. Determine the epidemic of etiology and condition of management of three major nosocomial infection in ICU in China.

Eligibility criteria: Inclusion Criteria:all patients admitted into ICU

Primary outcomes:
measure: morbidity
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of Critical Care , Zhong-da Hospital
state: Jiangsu
Study officials:
affiliation: Department of Critical Care Medicine, Zhongda Hospital
name: Jianfeng Xie
role: PRINCIPAL_INVESTIGATOR
References:
citation: Xie J, Yang Y, Huang Y, Kang Y, Xu Y, Ma X, Wang X, Liu J, Wu D, Tang Y, Qin B, Guan X, Li J, Yu K, Liu D, Yan J, Qiu H. The Current Epidemiological Landscape of Ventilator-associated Pneumonia in the Intensive Care Unit: A Multicenter Prospective Observational Study in China. Clin Infect Dis. 2018 Nov 13;67(suppl_2):S153-S161. doi: 10.1093/cid/ciy692.
Clinical trial NCT01437631: EFficacy of Prophylactic Clip Application in Decrease of Immediate Postpolypectomy Bleeding and Delayed Postpolypectomy Bleeding After Colonoscopic Removal for a Large Pedunculated Polyps
Official title: Does a Prophylactic Clip Application Decrease IPPB(Immediate Postpolypectomy Bleeding) and DPPB(Delayed Postpolypectomy Bleeding) After Colonoscopic Removal for a Large Pedunculated Polyps (>1cm)?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polyp of Large Intestine
Keywords: colon polyp
endoscopic polypectomy
postpolypectomy bleeding
prophylactic clip application
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2011-09-21
Enrollment: 137
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to evaluate the efficacy of prophylactic clip application after colonoscopic removal for a large pedunculated polyp (\> 1cm) in preventing immediate postpolypectomy bleeding (IPPB) and delayed postpolypectomy bleeding (DPPB).


Eligibility criteria: Inclusion Criteria:

* Patients who have a large pedunculated polyp(\>1cm) in the colon

Exclusion Criteria:

* Age under 20 years
* Subjects who are taking anticoagulants
* Subjects who have an abnormal coagulogram (platelet count, international normalized ratio, or activated partial thromboplastin time)
* Subjects who have inflammatory bowel diseases

Primary outcomes:
measure: the occurrence of immediate post-polypectomy bleeding
timeFrame: 1 day
measure: the occurrence of delayed post-polypectomy bleeding
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Kyung-Jo Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shioji K, Suzuki Y, Kobayashi M, Nakamura A, Azumaya M, Takeuchi M, Baba Y, Honma T, Narisawa R. Prophylactic clip application does not decrease delayed bleeding after colonoscopic polypectomy. Gastrointest Endosc. 2003 May;57(6):691-4. doi: 10.1067/mge.2003.193.
citation: Soh JS, Seo M, Kim KJ. Prophylactic clip application for large pedunculated polyps before snare polypectomy may decrease immediate postpolypectomy bleeding. BMC Gastroenterol. 2020 Mar 12;20(1):68. doi: 10.1186/s12876-020-01210-5.
Clinical trial NCT05396131: The Use of Aeriseal ® in the Management of Collateral Ventilation Positive COPD Patients Undergoing ELVR Utilizing Endobronchial Valves.
Official title: The Use of Aeriseal ® in the Management of Collateral Ventilation Positive COPD Patients Undergoing ELVR (Endoscopic Lung Volume Reduction) Utilizing Endobronchial Valves
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Lead sponsor: Macquarie University, Australia
Sponsor class: OTHER
First posted: 2022-05-31
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants diagnosed as either Collateral Ventilation (CV) Negative or CV Positive.

CV Negative participants will only receive the endobronchial valves (EBV). CV Positive participants will receive both the lung sealant and the EBV.
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine the feasibility of combining a lung sealant with endobronchial valves EBV in managing patients with COPD who are collateral ventilation (CV) positive. This study has two arms; arm 1 is for CV positive participants who will receive the lung sealant and EBV; arm 2 is the CV negative group who will only receive EBV as the standard management.


Eligibility criteria: Inclusion Criteria:

* i. 18-85 years of age
* ii. Forced Expiratory Volume in 1second (FEV1) 20 - 50%
* iii. Residual Volume (RV) \> 175%
* iv. 6 min walk test \> 150 m
* v. Completed a course of Pulmonary rehabilitation
* vi. STRATX assessment - Left Upper Lobe as the most appropriate lobe to target for ELVR
* vii. This study will be investigating heterogenous emphysema only. Minimum of 15% differential in emphysema destruction scores at -950 HU

Exclusion Criteria:

* i. Acute uncontrolled medical illness including ischemic heart disease, cardiac failure, acute renal impairment
* ii. Acute respiratory tract infections
* iii. Significant bronchiectasis,
* iv. Co-existing interstitial lung diseases, pneumothorax,
* v. Known active malignancy
* vi. Pregnancy.

Primary outcomes:
measure: Number of Participants converted from Collateral Ventilation positive (CV+) to Collateral Ventilation negative (CV-)
timeFrame: 4 weeks post lung sealant application
Secondary outcomes:
measure: Number of participants with improved lung functioning as measured by lung function tests
timeFrame: 12weeks and 52 weeks post valve implant
measure: Changes Lung volume
timeFrame: 12weeks and 52 weeks post valve implant
Other outcomes:
Locations:
city: Macquarie Park
country: Australia
facility: Macquarie University
state: New South Wales
Study officials:
affiliation: Clinical Professor and Respiratory Physician
name: Alvin J Ing, MBBS, MD, FRACP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02036931: A Multicentre Observational Study to Evaluate Clinical Outcomes of the G7 Acetabular System
Official title: A Multicentre Observational Study to Evaluate Clinical Outcomes of the G7 Acetabular System
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Noninflammatory Degenerative Joint Disease
Rheumatoid Arthritis
Keywords: Joint
Osteoarthritis
Avascular Necrosis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2014-01-15
Enrollment: 315
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: The primary purpose of this study is to evaluate the clinical and radiographic performance of the G7 Acetabular Cup System.

Detailed description: The primary purpose of this study is to evaluate the clinical and radiographic performance of the G7 Acetabular Cup System in both primary and revision procedures, report safety and survivorship, and document instrument ease of use.

Eligibility criteria: Inclusion Criteria:

* Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
* Rheumatoid arthritis
* Correction of functional deformity
* Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
* Revision procedures where other treatment or devices have failed
* 18 years of age or older
* Subjects willing to return for follow-up evaluations

Exclusion Criteria:

* Infection, sepsis and osteomyelitis
* Subjects unable to cooperate with and complete the study
* Neurological conditions affecting movement
* Pregnancy

Primary outcomes:
measure: Harris Hip Score
timeFrame: 2 Year post-operative
Secondary outcomes:
measure: Oxford Hip Score
timeFrame: 1 Year post-operative
measure: Oxford Hip Score
timeFrame: 2 Year post-operative
measure: Oxford Hip Score
timeFrame: 5 Year post-operative
measure: Radiographic Evaluation
timeFrame: 1 Year post-operative
measure: Radiographic Evaluation
timeFrame: 2 Year post-operative
measure: Radiographic Evaluation
timeFrame: 5 Year post-operative
measure: Survivorship
timeFrame: 7 Year post-operative
measure: Survivorship
timeFrame: 10 Year post-operative
measure: Adverse Events
timeFrame: Up to 10 years postoperatively
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University Orthopedic Specialists
state: Arizona
city: Clermont-Ferrand
country: France
facility: Clermont-Ferrand Hospital
city: Würzburg
country: Germany
facility: University of Würzburg, Orthopedic
city: Limerick
country: Ireland
facility: Midwestern Regional Orthopaedic Hospital
city: Delft
country: Netherlands
facility: Reinier de Graaf Groep
city: Ponferrada
country: Spain
facility: Hospital El Bierzo
Study officials:
affiliation: Zimmer Biomet
name: Hassan Achakri, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02788682: Association of Vitamin D Binding Protein Polymorphisms With Response to HCV Therapy
Official title: Association of Vitamin D Binding Protein Polymorphisms With Response to Therapy in Chronic Hepatitis C Egyptian Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Hepatitis C
Keywords: VDBP
single nucleotide polymorphisms (SNPs)
interferon based therapy
Egypt
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-06-02
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic Hepatitis C patients in Egypt

Brief summary: Introduction: Vitamin D binding protein (VDBP) is a potential modulator of immune response and is associated with clinical progression of many diseases. Our aim is to assess influence of baseline 25-hydroxyvitamin D levels and VDBP single nucleotide polymorphisms (SNPs), rs4588 (C\>A) and rs7041 (G\>T), on baseline clinical parameters and response to interferon based therapy in chronic Hepatitis C patients in Egypt.

Methodology: Genotyping will be performed by RFLP (Restriction Fragment Length Polymorphism) in treatment naïve Hepatitis C patients and healthy controls. Vitamin D levels will be assessed by ELISA. HCV RNA quantification will be performed by PCR to assess therapy outcome.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years and ≤ 60 years, fasting blood sugar less than 115 mg/dl or 20% upper normal limit (140 mg/dl), HBA1C ≤ 7.5% in diabetic patients, normal serum creatinine, normal thyroid stimulating hormone level, negative Hepatitis B surface antigen, hemoglobin ≥ 12g/dl for male or ≥ 11g/dl for female, total leukocytes ≥ 3,500/mm3, ANC ≥ 1500/mm3, platelets ≥ 100,000/mm3, presence of HCV RNA by PCR and elevated liver enzymes within the preceding 6 months for patients with F1 fibrosis stage.

Exclusion Criteria:

* hypersensitivity to interferon or ribavirin, decompensated liver cirrhosis (presence of ascites, esophageal varices or hepatic encephalopathy), hepatocellular carcinoma, body mass index\>35 Kg/m2 and vitamin D supplementation.

Primary outcomes:
measure: SVR
timeFrame: 72 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05690282: Comparing Perioperative Outcomes in Pain Control
Official title: Randomized Controlled Trial Comparing Multimodal Pain Protocol Versus Hydrocodone-Acetaminophen for Post-Operative Pain Management in Orthopaedic Surgery Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Post-operative Pain
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2023-01-19
Enrollment: 100
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: This project consists of a randomized controlled study design. Study candidates will include all patients 18 years or older, who were evaluated at UCSD and found to have an orthopaedic injury requiring surgery. Patients who consent to study participation will be randomized to receive either the multimodal pain management protocol or standard oral hydrocodone-acetaminophen for post-operative pain management. Data on opioid usage, pain control, and functional status will be collected for each participant. After 3 years of data collection, investigators will analyze this data to provide further insight in determining appropriateness of pain regimens that reduce the overall opioid consumption. Given the widespread opioid epidemic, it is imperative to develop alternative means to appropriately manage pain in orthopaedic surgery patients.


Eligibility criteria: Inclusion Criteria:

* Orthopaedic injury requiring surgery
* Evaluation and treatment at UCSD
* Age 18years or older
* Ability to understand the content of the patient information/Informed Consent Form
* Signed and dated Institutional Review Board (IRB) approved written informed consent

Exclusion Criteria:

* Polytrauma
* Any not medically managed severe systemic disease
* Their doctor has decided that it is in the patient's best interest to receive pain management regimen of one type vs. the other.
* The patient prefers one type of pain management protocol and is not willing to be randomized.
* Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment or confound pain control
* Pregnancy or women planning to conceive within the subject participation period (1 year)

  o Pregnancy will be self-reported and no test will be performed to test for it.
* Prisoner
* Participation in any other pharmacologic or medicinal product study within the previous month that could influence the results of this study.

Primary outcomes:
measure: Morphine equivalents used
timeFrame: 1 year
Secondary outcomes:
measure: Pain Score (0-10, 0=no pain, 10=most severe pain)
timeFrame: 1 year
measure: Number of Complications
timeFrame: 1 year
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego
state: California
Study officials:
References:
Clinical trial NCT01574482: Effect of the Consumption of a Fermented Milk Enriched With Plant Sterols (Italy)
Official title: Effects of the Consumption of a Plant Sterols-enriched Dairy Fermented Product on Hypercholesterolemia Management in Hypercholesterolemic Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mildly Hypercholesterolemic Subjects
Keywords: Plant sterol - Hypercholesterolemia - diet - dairy
Lead sponsor: Danone Global Research & Innovation Center
Sponsor class: INDUSTRY
First posted: 2012-04-10
Enrollment: 116
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to investigate the cholesterol lowering effect of a drinkable low fat fermented milk enriched with plant sterol after 3 and 6 weeks of daily consumption in mildly hypercholesterolemic people treated or not by statins


Eligibility criteria: Inclusion Criteria:

* male and female aged 20-75 years; BMI between 19 and 30 kg/m2 , LDL-cholesterol plasma level between 130 mg/dL to 190 mg/dL (bounds included) with or without any statin monotherapy, with stabilized hypercholesterolemia (since more than 3 months), accepting to follow the dietary recommendations advisable for hypercholesterolemic patient (NCEP-ATP III guidelines), used to consume dairy products, agreeing to a written informed consent, for female: effective contraceptive methods used

Exclusion Criteria:

* Subject with plasma triglycerides (TG) levels \> or = 350 mg/dL, with any cardiovascular event in the last 6 months, Subject taking any drugs affecting lipid metabolism (including hypocholesterolemic treatment) other than statin in monotherapy, Diabetic (type I and type II), smoking strictly more than 20 cigarettes/day, presenting known allergy or hypersensitivity to milk proteins, and soy, receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters, with renal failure or any other metabolic disorder which could interfere with the evaluation of efficiency or safety of the product , pregnant and breast feeding women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Perugia
country: Italy
facility: Ospedale Silvestrini
Study officials:
References: