louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02263612: Late Mesh Complications After 3258 Incisional Hernia Operations
Official title: Late Mesh Complications After 3258 Incisional Hernia Operations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Incisional Hernia
Keywords: Incisional Hernia
Complications
Long-term
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2014-10-13
Enrollment: 3258
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All incisional hernia repairs registered in tha Danish National Hernia Database from January 1st 2007 to December 31st 2010

Brief summary: The Danish Hernia Database (DHD) registers 37 different perioperative parameters. The aim of present study is to use large-scale data from DHD to uncover risk factors for long-term (30 days postoperative and later) readmission, reoperation, death and reoperation for recurrence after incisional hernia repair with use of a synthetic mesh.

Detailed description: All principal incisional hernias registered in the Danish Hernia Database are included in the study. The included patients have been followed for more than 4 years in order to identify correlation between technical aspects of the hernia repair and postoperative morbidity.

Eligibility criteria: Inclusion Criteria:

* Incisional Hernia Repair

Primary outcomes:
measure: Reoperation
timeFrame: Up to 7 years
Secondary outcomes:
measure: Readmission
timeFrame: Up to 7 years
Other outcomes:
measure: Death
timeFrame: Up to 7 years
Locations:
city: Køge
country: Denmark
facility: Køge Sygehus
Study officials:
affiliation: dept. of surgery, Køge University Hospital
name: Dunja Kokotovic, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03977012: Neuroimaging Study on the Effect of Transdermal Buprenorphine in Complex Regional Pain Syndrome Patients
Official title: Neuroimaging Study on the Effect of Transdermal Buprenorphine in Complex Regional Pain Syndrome(CRPS) Patients With Chronic Lower Back Pain: A Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Complex Regional Pain Syndromes
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-06-06
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with complex regional pain syndrome Type I (Budapest Criteria)

Brief summary: In the present study, we aim to investigate the effect of buprenorphine on neuroinflammation in patients with complex regional pain syndrome, using \[11C\]-(R)-PK11195 PET.


Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with complex regional pain syndrome Type I (Budapest Criteria) and persistent back pain (VAS ≥ 4).
2. Patients who can stop benzodiazepine treatment 2 weeks before study
3. Patients who initially decided to use buprenorphine according to clinical judgment
4. Patients who are able to understand the purpose and procedure of the study

Exclusion Criteria:

1. Patients with an impaired cognitive function such as psychosis, dementia, or mental retardation
2. Patients with neurologic disease, cerebrovascular disease, history of brain tumor, history of severe head trauma, history of convulsive disease
3. Patients with cardiovascular disease, liver, respiratory or renal dysfunction
4. Patients with biliary disease
5. Patients who could not undergo the PET/magnetic resonance imaging (MRI) process.
6. Patients who have a risk of suicide or show aggressive behavior
7. Patients who have drug dependence (DSM-IV criteria) or history (past 6 months or older)
8. Employees of researchers or clinical research institutes
9. Patients with hypersensitivity or contraindication to buprenorphine

Primary outcomes:
measure: Changes in neuroinflammation
timeFrame: baseline, 8 weeks
Secondary outcomes:
measure: Morphine equivalent
timeFrame: baseline, 8 weeks
measure: Physical test(1)
timeFrame: baseline, 8 weeks
measure: Physical test(2)
timeFrame: baseline, 8 weeks
measure: Physical test(3)
timeFrame: baseline, 8 weeks
measure: Physical test(4)
timeFrame: baseline, 8 weeks
measure: Physical test(5)
timeFrame: baseline, 8 weeks
measure: Self-reported questionnaire(1)
timeFrame: baseline, 8 weeks
measure: Self-reported questionnaire(2)
timeFrame: baseline, 8 weeks
measure: Self-reported questionnaire(3)
timeFrame: baseline, 8 weeks
measure: Self-reported questionnaire(4)
timeFrame: baseline, 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongno-gu
Study officials:
References:
Clinical trial NCT00390312: Efficacy and Safety of Intranasal Morphine for Pain After Third Molar Extraction
Official title: Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Single Dose Comparison of Analgesic Efficacy and Safety of Intranasal Morphine, Immediate Release Oral Morphine, Intravenous Morphine and Placebo in Postsurgical Dental Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Post-Operative Pain
Third Molar Extraction
Keywords: Post operative pain
Third molar extraction
Dental surgery
Morphine
Lead sponsor: Javelin Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2006-10-19
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study involves approximately 200 patients designed to evaluate the efficacy and safety of intranasal (IN) morphine 7.5 mg and 15 mg, intravenous morphine (IV) 7.5 mg, immediate release oral (PO) morphine 60 mg or placebo in patients with acute postsurgical pain following third molar extraction.

Detailed description: Diagnosis and Main Criteria for Inclusion: Dental outpatients undergoing the removal of 3 or more third molars (2 of which were required to be mandibular and both must be bony impacted third molars).

Eligibility criteria: Inclusion Criteria:

* Male or female 18-40 years of age
* Surgical extraction of at least three or more third molars (two must be mandibular and both must be bony impacted third molars)
* Moderate or severe pain within 6 hours of completion of surgery

Exclusion Criteria:

* Other oral surgical procedures during the same session except the removal of supernumerary third molars
* Evidence of nasal congestion, nasal polyps, mucosal lesions of the nostrils, postnasal drip of any etiology or any clinically significant nasal pathology that may affect the absorption of study medication or the assessment of safety
* Chronic respiratory insufficiency such that treatment with an opioid analgesic is contraindicated
* Allergy to shellfish

Additional Inclusion/Exclusion Criteria May Apply

Primary outcomes:
measure: Total pain relief (TOTPAR) at the 0-2 hour time interval calculated as the time-weighted sum of the Pain Relief (PR) scores for the time interval 0-2 hours
timeFrame: 2 hours
Secondary outcomes:
measure: Other measures of pain relief
timeFrame: Several time points
Other outcomes:
Locations:
Study officials:
affiliation: Jean Brown Associates, Inc.
name: Kyle Christensen, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00101712: Efficacy and Safety of Vildagliptin Compared to Placebo in Patients With Type 2 Diabetes and Mild Hyperglycemia
Official title: Efficacy and Safety of Vildagliptin Compared to Placebo in Patients With Type 2 Diabetes and Mild Hyperglycemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: type 2 diabetes
vildagliptin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-01-13
Enrollment: 274
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: This study is not being conducted in the United States. Key long-term clinical studies have shown that people with type 2 diabetes should try to achieve overall blood glucose levels as close to normal as possible. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar and whose blood glucose levels are close to normal.


Eligibility criteria: Inclusion Criteria:

* Blood glucose criteria must be met
* Not currently on drug therapy for type 2 diabetes
* Body mass index (BMI) in the range 22-45
* Diagnosis of type 2 diabetes for at least 8 weeks

Exclusion Criteria:

* Pregnancy or lactation
* Type 1 diabetes
* Evidence of serious diabetic complications
* Evidence of serious cardiovascular complications
* Significant laboratory abnormalities as defined by the protocol
* Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Change from baseline in HbA1c at 52 weeks
Secondary outcomes:
measure: Adverse event profile after 52 weeks of treatment
measure: Patients with HbA1c <6.5% at 12 weeks
measure: Patients with HbA1c <6.5% at 52 weeks
measure: Change from baseline in fasting plasma glucose at 52 weeks
measure: Coefficient of failure for HbA1c between 24 weeks and 52 weeks
Other outcomes:
Locations:
city: Investigative Site
country: Germany
facility: Novartis Investigative Site
city: Basel
country: Switzerland
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Scherbaum WA, Schweizer A, Mari A, Nilsson PM, Lalanne G, Jauffret S, Foley JE. Efficacy and tolerability of vildagliptin in drug-naive patients with type 2 diabetes and mild hyperglycaemia*. Diabetes Obes Metab. 2008 Aug;10(8):675-82. doi: 10.1111/j.1463-1326.2008.00850.x. Epub 2007 Nov 22.
citation: Mari A, Scherbaum WA, Nilsson PM, Lalanne G, Schweizer A, Dunning BE, Jauffret S, Foley JE. Characterization of the influence of vildagliptin on model-assessed -cell function in patients with type 2 diabetes and mild hyperglycemia. J Clin Endocrinol Metab. 2008 Jan;93(1):103-9. doi: 10.1210/jc.2007-1639. Epub 2007 Oct 9.
Clinical trial NCT02238912: Evaluation of Preclinical Toxicity andTherapeutic Efficacy of Kandhaga Rasayanam in Padarthamarai
Official title: Evaluation of Preclinical Toxicity of a Siddha Formulation Kandhaga Rasayanam ( KR ) and Its Therapeutic Efficacy in Padarthamarai ( Dermatophytoses ) by an Open Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tinea Infections Such as Tinea Corporis, Tinea Cruris, Tinea Pedis, Tinea Mannum, Tinea Barbae, Tinea Capitis Are Studied
Keywords: tinea
Lead sponsor: National institute of Siddha
Sponsor class: OTHER_GOV
First posted: 2014-09-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: this study is intended to find out the therapeutic efficacy of the siddha drug Kandhaga Rasayanam in Padarthamarai ( Ring worm infection )


Eligibility criteria: Inclusion Criteria:

* patients clinically diagnosed with tinea infection.
* direct microscopy skin scraping test positive.

Exclusion Criteria:

* pregnant or nursing women.
* use of other topical or oral antifungals, immunosuppressive drugs, anthelmintic drugs either currently or during 2 weeks preceeding initiation of drug trial.
* allergy or hyperensitivity to any component of the drug.
* clinical case of eczema, lichen planus, pityriasis versicolor, drug induced eruptions, urticaria, intertrigo, tinea ungium.
* diabetic patients.

Primary outcomes:
measure: skin scrapping test
timeFrame: 45 days
Secondary outcomes:
measure: itching, quality of life
timeFrame: 45 days
Other outcomes:
measure: burning sensation, vanishing of lesions
timeFrame: 45 days
Locations:
city: Chennai
country: India
facility: National institute of siddha
state: Tamilnadu
Study officials:
References:
citation: AYUSH PORTAL, GOOGLE SCHOLAR
Clinical trial NCT01432912: Study Evaluating the Effect of Physician Education on Smoking Cessation Counselling
Official title: Pilot Study Evaluating the Influence of Physician Education Regarding the 5A's Smoking Cessation Counselling Strategy, as Evaluated by Patient Interpretation of the Strategy Principles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Lead sponsor: Assuta Hospital Systems
Sponsor class: OTHER
First posted: 2011-09-13
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of the study is to see if a short seminar educating physicians about smoking cessation counselling will effectively improve their smoking counselling cessation practices.


Eligibility criteria: Inclusion Criteria:

* Patients 18yrs and over that visit the participating physicians and agree to compete the study questionnaire

Primary outcomes:
measure: Patient assessment questionnaires
timeFrame: Within a month after the seminar.
Secondary outcomes:
Other outcomes:
Locations:
city: Modiin
country: Israel
facility: Maccabi Healthcare Services
Study officials:
References:
Clinical trial NCT04047212: The Link Between Periodontitis, Smoking and Oral Cancer
Official title: Analysis of the Link Between Periodontitis, Smoking and Oral Cancer: Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Periodontitis
Oral Cancer
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-08-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult individuals

Brief summary: Periodontitis is a widely prevalent disease worldwide that has serious public health consequences. Its prognosis includes tooth loss and edentulism, a condition that negatively affects chewing causing functional disability; and esthetics causing social impairment. Consequently, periodontitis may end up causing marked impairment of the quality of life of the affected patients, impairment of general health and increasing the dental care costs significantly.

Changes in the oral mucosa arise by primary products resulting from tissue breakdown due to gingivitis. It then triggers the host cells to produce proteinases that mediate loss of marginal periodontal ligaments, apical migration of the junctional epithelium and apical spread of bacterial biofilm.

Therefore, this research aims to identify the risk of smoking to both periodontitis and oral cancer, and the risk of periodontitis to oral cancer.


Eligibility criteria: Inclusion Criteria:

* Patients 18 years or older.

Exclusion Criteria:

* Patients with any systemic diseases.
* Pregnant females.
* Handicapped and mentally retarded patients.
* Patients undergoing radiotherapy.
* Patients having oral cancer

Primary outcomes:
measure: Periodontitis
timeFrame: the 10 years of the study
Secondary outcomes:
measure: Oral cancer
timeFrame: the 10 years of the study
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT04675112: Genetically-informed Behavioral and Cognitive Interventions for the Management of Tinnitus
Official title: Genetically-informed Behavioral and Cognitive Interventions for the Management of Tinnitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tinnitus
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2020-12-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Psychological and behavioral interventions, such as Cognitive Behavioral Treatment (CBT) and Tinnitus Retraining Therapy (TRT), are commonly applied either alone or in combination for the management of tinnitus but selection of the intervention model remains arbitrary. Our purpose is to evaluate the hypothesis that genetic markers may guide the choice of tinnitus treatment towards improved therapeutic outcomes. Patients with subjective idiopathic tinnitus are assigned to either a genetically-informed CBT or TRT intervention protocol based on the status of four single nucleotide polymorphisms (SNPs) of the dopamine and serotonin pathways, namely COMT rs4680, HTR2A rs7997012, HTR2A rs6311, and TPH2 rs4570625, that have been associated with behavioral or cognitive responses (Group A), or to a conventional approach (Group B) in which the choice of treatment was not directed by genotypic data. Tinnitus Handicap Index (THI) scores of perceived tinnitus severity are recorded at the initial and at the fourth session of treatment using appropriate questionnaires.


Eligibility criteria: Inclusion Criteria:

* adult patients with bothersome bilateral non-pulsative tinnitus and hearing loss

Exclusion Criteria:

* no major comorbidities
* no psychiatric history

Primary outcomes:
measure: Tinnitus Handicap Inventory (THI)
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: ENT clinic
Study officials:
References:
Clinical trial NCT06287112: Prevention of Acute Cholecystitis With ETGBD
Official title: Efficacy of ETGBD Parallel Insertion With Fully Covered Self-expandable Metal Stent for Preventing Acute Cholecystitis in Patients With Low Cystic Duct Insertion
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Biliary Obstruction
Acute Cholecystitis
Keywords: Malignant biliary obstruction
Fully covered self expandable metal stent
Endoscopic transpapillary gallbladder drainage
Preventive Effect
Acute cholecystitis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 35
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to learn about Efficacy of the ETGBD parallel insertion with fully covered self-expandable metal stent for preventing acute cholecystitis in patients with low cystic duct insertion.

In this study, we hypothesized that endoscopic transpapillary gallbladder drainage (ETGBD) with parallel insertion of a fully covered self-expanding metal stent(FCSEMS) through an endoscopic biliary drainage tunnel is superior in preventing complications such as cholecystitis when the gallbladder ducts confluence within the distal third of the common bile duct. And we aimed to confirm its efficacy by comparing the frequency, severity, and rate of invasive additional procedures due to cholecystitis complications to provide evidence of clinical utility.


Eligibility criteria: Inclusion Criteria:

1. Adults 19 years of age or older
2. Patients requiring endoscopic retrograde cholangiography and drainage for therapeutic purposes.
3. Patients with imaging (CT, Cholangiogram) confirmed confluence of the cystic duct with the distal third of the common bile duct.
4. Patients who have voluntary informed consent to participate in the study.

Exclusion Criteria:

* Patients who have undergone percutaneous/surgical bile duct or gallbladder drainage prior to study enrollment.
* Patients with anatomic deformity of the upper gastrointestinal tract after gastric or hepatobiliary surgery
* Patients with concomitant gastric/duodenal obstruction
* Patients with confirmed or suspected cystic duct obstruction on imaging studies
* Patients with acute cholecystitis, acute pancreatitis
* Patients who underwent cholecystectomy
* Patients with a life expectancy of less than 3 months
* Patients who are otherwise unable to undergo endoscopic retrograde cholangiopancreatography

Primary outcomes:
measure: Incidence rate of acute cholecystitis
timeFrame: 2 months from the date of stent placement
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Woo Hyun Paik, MD., PhD.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03861312: Laterality Discrimination in Patients With Non-specific Chronic Neck Pain
Official title: Effects of Laterality Discrimination in Patients With Non-specific Chronic Neck Pain. Randomized Blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: Laterality task, neck pain
Lead sponsor: Centro Universitario La Salle
Sponsor class: OTHER
First posted: 2019-03-04
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic neck pain is one of the most common causes of pain, affecting 15% of the adult population, and the fourth leading cause of disability. The recognition of laterality is the ability to recognize a part of the body that belongs to the left or right which is used as a tool to create a normal process of motor planning.

Detailed description: The most consistent data come from the investigation of the primary motor cortex, in which the cortical representations of the altered body part are affected when there is chronic pain. Occasionally, the primary motor cortex is smaller on the affected side than on the contralateral side.

Recognition of the body schema is altered in the presence of painful disorders. The most common way of assessing the body schema is by motor imagery through the laterality discrimination of the left and right.

Eligibility criteria: Inclusion Criteria:

* The inclusion criteria were as follows: a) men and women aged between 18- and 65-years b) medical diagnosis of Non-Specific Chronic Neck Pain with more than 6 months of evolution of neck pain.

Exclusion Criteria:

* Exclusion criteria included the following: a) patients with rheumatic diseases, cervical hernia, cervical whiplash syndrome, neck surgeries or history of arthrodesis, b) systemic diseases, c) vision, hearing or vestibular problems, d) Severe trauma or traffic accident which has had an impact on the cervical area.

Primary outcomes:
measure: Response time
timeFrame: Immediately post-intervention
measure: Accuracy
timeFrame: Immediately post-intervention
measure: Joint Position Error
timeFrame: Immediately post-intervention
measure: Cervical Active Range of Motion
timeFrame: immediately post-intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: d.marcosl20@gmail.com
name: David Marcos Lorenzo, Msc
role: STUDY_CHAIR
References: