louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04195295: Regeneration of Intrabony Defects With Nano Hydroxyapatite Graft, and Periosteum as Barrier Membrane Under Magnification
Official title: Regeneration of Intrabony Defects With Nano Hydroxyapatite Graft, Derived From Egg Shell Along With Periosteum as Barrier Membrane Under Magnification - An Interventional Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intrabony Periodontal Defect
Lead sponsor: Krishnadevaraya College of Dental Sciences & Hospital
Sponsor class: OTHER
First posted: 2019-12-11
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The prospective study is a interventional study to evaluate and compare the effectiveness of periosteal pedicle as grafting technique and egg shell derived nano hydroxyapatite as regenerative graft material for regeneration of intrabony defects.

Detailed description: 30 Patients visiting the outpatient Department of Periodontology Krishnadevaraya College of Dental Sciences and Hospital, Bangalore will be enrolled for 6 month folllow up study based on the inclusion and exclusion criteria. Patients age ranged from 25 to 55 years. Patients with chronic periodontitis, with presence of intrabony defects with ≥6mm probing depth (PD), 2 or 3 wall defects are included in the study.

The patients are allocated to three goups through computer generated randomisation as:

Group A (n=10) - Egg shell derived nano hydroxyapatite (EnHA) graft and periosteal pedicle as barrier membrane.

Group B (n=10) - Only EnHA as graft. Group C (n=10) - An open flap debridement procedure only.

Eligibility criteria: Inclusion Criteria:

1. Patients within the age group of 25 to 55 years.
2. Patients with chronic periodontitis, with presence of intrabony defects with ≥6mm probing depth (PD), 2 or 3 wall defects as detected on CBCT.
3. Gingival biotype \>1.5mm
4. Systemically healthy subjects.
5. Patients who are compliant.
6. Patients who had not received any periodontal treatment in the last six months.

Exclusion Criteria:

1. Pregnant and Lactating females.
2. Aggressive periodontitis.
3. Presence of pulpal or periapical involvement.
4. Patients with known systemic diseases and conditions precluding any elective surgery.
5. Patients who were smokers.
6. Teeth with poor prognosis.

Primary outcomes:
measure: Bone defect fill and density
timeFrame: 6 months
Secondary outcomes:
measure: Probing pocket depth
timeFrame: 6 months
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Krishnadevaraya college of dental sciences
state: Karnataka
Study officials:
affiliation: Krishnadevaraya College of Dental Sciences
name: Dr. Rashmi P, MDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06483581: Comparison of M-TAPA and TAP Blocks on Postoperative Analgesia in Laparoscopic Appendectomy Surgeries
Official title: Comparison of the Analgesic Effects of Modified Thoracoabdominal Nerve Block Through Pericondrial Approach (M-TAPA) and Transversus Abdominis Plane (TAP) Block in Laparoscopic Appendectomy Surgeries
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Post Operative Pain
Keywords: m-tapa
tap block
laparoscopic appendectomy
regional anesthesia
postoperative pain
Lead sponsor: Cumhuriyet University
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this study is to compare the analgesic efficacy of M-TAPA block and TAP block in patients undergoing laparoscopic appendectomy surgeries

Detailed description: There will be two randomized groups: Group M-TAPA (n=15), Group TAP (n=15). All patients will have standard general anesthesia. Group M-TAPA patients will receive bilateral M-TAPA block with 0.25% bupivacaine (total volume of 40 ml). Group TAP patients will have bilateral lateral-TAP block with 0.25% bupivacaine (total volume of 40 ml). All blocks will be performed after general anesthesia induction, before skin incision. All patients in the study will receive 50 mg dexketoprofen and 1 gr paracetamol intravenos (i.v.) 10 minutes prior to skin closure. All patients will have ibuprofen 3x400 mg in postoperative 24 hours (maximum dose 1200 mg/day). Numerical rating scale (NRS) will be used to assess postoperative pain on 1st, 6th, 12th, 18th and 24th hour after the surgery. 50 mg tramadol will be administered as a rescue analgesic in all patients.Total tramadol consumption will be calculated.

Eligibility criteria: Inclusion Criteria:

* Adult patients older than 18 years of age who will undergo laparoscopic appendectomy under general anesthesia and will be American Society of Anesthesiologists (ASA) I-II-III according to the ASA risk classification.

Exclusion Criteria:

* Patients who did not give consent,
* patients with coagulopathy,
* patients with signs of infection at the block application site,
* patients using anticoagulants,
* patients with local anesthetic drug allergies,
* patients undergoing open surgery,
* patients with unstable hemodynamics,
* patients who could not cooperate during postoperative pain assessment

Primary outcomes:
measure: Comparing the numerical rating scale scores
timeFrame: Postoperative 24 hours
Secondary outcomes:
measure: Comparing total tramadol consumption
timeFrame: Postoperative 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation
name: Oğuz Gündoğdu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04884581: Characterization of Colorectal Neoplasia
Official title: The CHANGE Study: Characterization Helping the Assessment of Colorectal Neoplasia in Gastrointestinal Endoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonic Polyp
Lead sponsor: Nuovo Regina Margherita Hospital
Sponsor class: OTHER
First posted: 2021-05-13
Enrollment: 165
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a post-marketing, single-arm, prospective study investigating the use of GI Genius CADx device in the real-time characterization of colorectal polyps (i.e. prediction of their histology during the colonoscopy). Patients enrolled will undergo a standard white-light colonoscopy with the support of the latest version of the CE-marked GI Genius CADx device. Colonoscopy will be performed according to the standard practice.


Eligibility criteria: Inclusion Criteria:

* Patients aged 40 years or older undergoing screening colonoscopy for CRC
* Ability to provide written, informed consent (approved by EC) and understand the responsibilities of trial participation

Exclusion Criteria:

* subjects at high risk for colorectal cancer
* subjects with a personal history of CRC, IBD or hereditary polyposis or non-polyposis syndromes
* patients with previous resection of the sigmoid rectum
* patients on anticoagulant therapy, which precludes resection / removal operations due to histopathological findings
* patients who perform an emergency colonoscopy

Primary outcomes:
measure: Negative Predictive Value (NPV)
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
measure: Post-polypectomy surveillance interval
timeFrame: 4 months
measure: Performance metrics of GI Genius CADx
timeFrame: 4 months
measure: Performance metrics of the endoscopist with the aid of GI Genius CADx
timeFrame: 4 months
Locations:
city: Roma
country: Italy
facility: Nuovo Regina Margherita
Study officials:
References:
citation: Hassan C, Balsamo G, Lorenzetti R, Zullo A, Antonelli G. Artificial Intelligence Allows Leaving-In-Situ Colorectal Polyps. Clin Gastroenterol Hepatol. 2022 Nov;20(11):2505-2513.e4. doi: 10.1016/j.cgh.2022.04.045. Epub 2022 Jul 11.
Clinical trial NCT05048381: miRNA in Sweat, a Novel Digital Biomarker for Detection of Active Tuberculosis (TB)
Official title: miRNA in Sweat, a Novel Digital Biomarker for Detection of Active Tuberculosis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Active Tuberculosis
Keywords: miRNA
Mycobacterium Tuberculosis
Next Generation Sequencing
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Fachhochschule Nordwestschweiz
First posted: 2021-09-17
Enrollment: 0
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: All participants in the Sweatb study (NCT03667742)

Brief summary: The detection of miRNA (non-coding ribonucleic acid) in the blood in the context of active tuberculosis is an innovative approach to the detection of new disease-specific biomarkers.

The primary goal of this analysis is to define, for the first time, an miRNA fingerprint for tuberculosis in sweat. Samples that were collected as part of the Sweatb Study (NCT03667742) project are examined for the occurrence of disease-specific, non-coding miRNAs to define new biomarkers in the sweat. These biomarkers can be detected non-invasively and will help in the detection of patients with active tuberculosis.


Eligibility criteria: Inclusion Criteria:

* Adult patients
* Ability to understand the purpose of the study, provide signed and dated informed consent by patient or his/her legal representative
* In-patients with acute tuberculosis, suspected tuberculosis or other pulmonary diseases (pneumonia, Bronchitis, COPD)

Inclusion criteria Healthy Donors:

* negative for Quantiferon- TB Gold Plus Test or ELISpot

Exclusion Criteria:

* Written rejection of the consent for the further use of the data

Primary outcomes:
measure: Detection of miRNA (non-coding ribonucleic acid) in sweat
timeFrame: Sweat samples taken at baseline
measure: Detection of miRNA (non-coding ribonucleic acid) in blood
timeFrame: Blood samples taken at baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Chief Medical Information Office (CMIO), University Hospital Basel
name: Jens Eckstein, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01886781: Effect of Lactobacillus Plantarum 299v on Symptoms of Irritable Bowel Syndrome
Official title: Randomised Controlled Trial: Effect of Lactobacillus Plantarum 299v on Symptoms of Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Irritable Bowel Syndrome
Keywords: only constipation and diarrhea predominant
no mixed or alternating types
Lead sponsor: University of Stellenbosch
Sponsor class: OTHER
Collaborators: name: Nestlè Nutrition Institute Africa
name: National Research Foundation (NRF) (RSA)
First posted: 2013-06-26
Enrollment: 81
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: In patients with IBS, will supplementation with a probiotic demonstrate symptomatic efficacy and will the probiotic influence gut microflora and thus improve clinical outcomes, as compared to no intervention.

Detailed description: Conduct a study on nutrient intakes gastrointestinal microbiota and the effect of a probiotic, Lactobacillus plantarum 299v in irritable bowel syndrome patients.

Eligibility criteria: Inclusion Criteria:

* fulfillment of the Rome II criteria for IBS,
* availability of at least one colonoscopy within the last three years,
* aged 18 or older at the time of screening,
* provision of written informed consent,
* commitment of availability throughout the 12 week study period.

Exclusion Criteria:

* major abdominal surgery in the past other than other than appendectomy, caesarean section, tubal laparoscopic cholecystectomy, abdominal wall hernia repair or/and hysterectomy,
* current use of antibiotics,
* history of organic intestinal disease,
* pregnant or breastfeeding mothers,
* chronic infectious disease like HIV or tuberculosis, and
* unable to understand English or Afrikaans.

Primary outcomes:
measure: A Change in Abdominal Pain Severity
timeFrame: Total trial period 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Port Elizabeth
country: South Africa
facility: Netcare Greenacres Hospital
state: Eastern Cape
Study officials:
affiliation: Univeristy of Stellenbosch
name: Cheryl Stevenson, M.Sc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03375281: Radiofrequency Ablation Using Octopus Electrodes for Small Hepatocellular Carcinoma With No-touch Technique
Official title: Radiofrequency Ablation Using Octopus Electrodes for Small Hepatocellular Carcinoma With No-touch Technique: A Prospective Single Arm Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Carcinoma
Radiofrequency Ablation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Starmed
First posted: 2017-12-18
Enrollment: 140
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate clinical outcome of RFA for small single nodular HCC using no touch technique with separable clustered electrode (Octopus) in a prospective multicenter manner Participating center: Seoul national university hospital, Asan medical center, Samsung medical center, Kunkuk university hospital, St. mary's Seoul hospital


Eligibility criteria: Inclusion Criteria:

* Child-Pugh class A liver function
* 1 - 2.5 cm sized Single nodular HCC
* without history of previous HCC treatment or with evidence of no recurrence at least 2 years after previous HCC treatment

Exclusion Criteria:

* more than 2 HCC
* tumor size larger than 2.5 cm
* Child-Pugh class B or C liver function
* invisible tumor even after real-time fusion US guidance
* accompanied by vascular invasion or distant metastasis
* presence of coagulopathy defined as platelet count \< 50,000/mm3 and/or PT-INR \> 50%

Primary outcomes:
measure: 1 year local tumor progression
timeFrame: 1 year after procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung medical center
city: Seoul
country: Korea, Republic of
facility: KonKuk university hospital
city: Seoul
country: Korea, Republic of
facility: Saint Mary Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jeong Min Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee DH, Lee MW, Kim PN, Lee YJ, Park HS, Lee JM. Outcome of No-Touch Radiofrequency Ablation for Small Hepatocellular Carcinoma: A Multicenter Clinical Trial. Radiology. 2021 Oct;301(1):229-236. doi: 10.1148/radiol.2021210309. Epub 2021 Jul 27.
Clinical trial NCT02245581: Evaluations of Optimizing Perioperative Fluid Management on Postoperative Pain Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients Major Laminectomy Surgery
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
First posted: 2014-09-19
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patient characteristics, duration of surgery, and infusion volumes will be compared between the groups. Oxygen transport and organ function will be compared Length of hospital stay, morbidity, postoperative pain intensity were compared. Continuous variables will be analyzed using the student t-test and discrete variables will be analyzed using Chi-Square test. P-value \<0.05 will be considered significant, where appropriate 95% confidence intervals will be calculated. Statistical analysis will be carried out using standardize statistical programs SPSS 12.0 for windows.


Eligibility criteria: Inclusion Criteria:

* All patients are undergoing elective spine laminectomy

Exclusion Criteria:

* age \<20 yr
* emergency surgery
* coagulopathy
* renal and hepatic dysfunction
* hyperthyroidism, and cardiac rhythm other than sinus rhythm

Primary outcomes:
measure: Pain at rest and movement
timeFrame: Post-operation Day1 to Day4
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
Study officials:
References:
Clinical trial NCT00816881: Application and Generalization of Flutter Mucus Clearance Device
Official title: Application and Generalization of Flutter Mucus Clearance Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Pulmonary Disease, Chronic Obstructive
flutter
airway clearance
sputum
Physical Therapy Techniques
Lead sponsor: Tongji University
Sponsor class: OTHER
First posted: 2009-01-05
Enrollment: 356
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
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 evaluate the clinical outcome and safety of flutter mucus clearance devices.

Detailed description: Respiratory diseases are still increasing in elder population. Sputum detaining is a common contributing factor to acute exacerbation. The fluttering mucus clearance technique is expected to be a physical assisting therapy enhancing airway secretion clearance but need more clinical randomized control trial evidence.

Eligibility criteria: Inclusion Criteria:

* Pulmonary department: available to perform the device, in-hospital patients

  * Male and female
  * Age: 45 - 85 years
  * Chronic bronchitis, COPD
* Thoracic surgery department and surgical department (upper abdomen):

  * Patients with endotracheal intubation of general anesthesia
  * Age: 40-75 years

Exclusion Criteria:

* Not available to perform the procedure
* Untreated pneumothorax
* Diffusion interstitial lung disease
* Acute coronary syndrome
* Third stage hypertension
* Advanced cancer
* Severe heart, liver, renal , blood system and endocrine system dysfunction
* Noninvasive mechanical ventilation more than 6 hrs per day
* Patients with invasive ventilation and cannot weaning and extubation within 48 hours
* Active hemoptysis

Primary outcomes:
measure: days of fever (body temperature reach 38 degree Celsius or higher), days of antibiotics therapy, hospital length of stay, or at 28 days
timeFrame: one year
Secondary outcomes:
measure: rate of noninvasive mechanical ventilation, rate of trachea intubation, mortality due to any reason until discharge, total fees of in-hospital
timeFrame: one year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
state: Shanghai
Study officials:
affiliation: Shanghai 10th People's Hospital
name: Zhang Xiangyu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang XY, Wang Q, Zhang S, Tan W, Wang Z, Li J. The use of a modified, oscillating positive expiratory pressure device reduced fever and length of hospital stay in patients after thoracic and upper abdominal surgery: a randomised trial. J Physiother. 2015 Jan;61(1):16-20. doi: 10.1016/j.jphys.2014.11.013. Epub 2014 Dec 19.
Clinical trial NCT06430281: Manual Therapy Force Perception Scale
Official title: Development and Pre-testing of a Manual Therapy Force Perception Scale
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Manual Therapy
Keywords: Chiropractic
Spinal mobilization
Spinal manipulation
force sensor
Lead sponsor: Université du Québec à Trois-Rivières
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Licensed chiropractors

Brief summary: The objective of this observational study is to pilot a scale designed to assist clinicians in evaluating the force they perceive during manual therapy.

The main question it aims to answer is:

- Are clinicians able to evaluate the force they use when delivering manual therapies to their patients using a scale?

For the pilot test, licensed chiropractors administer manual therapies on a manikin.

Detailed description: The aim of this observational study is to pilot test an ordinal scale (the Manual Therapy Force Perception \[MTFP\] scale) intended to enable clinicians to assign ordinal rankings to their patients based on their perception of the force they applied during manual therapy . This involved evaluating the agreement between the force applied by clinicians during spinal manipulations and mobilizations delivered on a manikin and their subjective perception of force, as determined using the MTFP scale. Additionally, the pilot study aimed to seek feedback on the MTFP scale from clinicians who are its potential users.

Eligibility criteria: Inclusion Criteria:

* Licensed chiropractors with a private practice within the province of Quebec, Canada.

Exclusion Criteria:

* Having a condition that prevents the execution of approximately 50 manual therapies over a 1-hour period.

Primary outcomes:
measure: Peak force measured by a force sensor during the manual therapy
timeFrame: During the manual therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Trois-Rivières
country: Canada
facility: Université du Québec à Trois-Rivières
state: Quebec
Study officials:
affiliation: Université du Québec à Trois-Rivières
name: Isabelle Pagé, DC, PhD
role: PRINCIPAL_INVESTIGATOR
References: