louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00378547: Effect of Paracetamol, Pregabalin and Dexamethasone on Pain and Opioid Requirements in Patients Having a Tonsillectomy
Official title: Effect of Paracetamol Versus Paracetamol Combined With Pregabalin Versus Paracetamol Combined With Pregabalin and Dexamethasone on Pain and Opioid Requirements in Patients Scheduled for Tonsillectomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pain, Postoperative
Keywords: Tonsillectomy
pregabalin
dexamethasone
multimodal postoperative analgesia
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
First posted: 2006-09-20
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients scheduled for a tonsillectomy need postoperative pain treatment. Some of the most widely used postoperative analgetics (NSAIDs) sometimes cause rebleeding in the postoperative period, and another often used analgetic, morphine, causes nausea and vomiting. The researchers therefore will investigate new combinations of postoperative analgesics in hopes of improving pain and the need for opioids during the postoperative period.

Detailed description: We will investigate the effect of paracetamol versus paracetamol combined with pregabalin versus paracetamol combined with pregabalin and dexamethasone on pain and morphine requirements in the first 24 hours postoperatively. Outcomes include amount of morphine and ketobemidone used, and pain measured on a VAS scale. Side-effects, e.g., PONV, dizziness and sedation are also measured.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for benign tonsillectomy
* Between the ages of 18 and 50 years old
* ASA 1-2 and a surgical technique without the need for local anaesthetics or electrical scissors

Exclusion Criteria:

* Malignancy
* Patients who are unable to cooperate
* Does not speak Danish
* Has allergy for drugs used in the trial
* Has abused drugs and/or medicine
* Epilepsy
* Diabetes treated with medicine
* Treatment with systemic steroids 4 weeks prior to the operation
* Daily use of antacids
* Daily use of analgesics
* Use of antidepressives
* Known kidney disease
* Pregnancy

Primary outcomes:
measure: Pain score (VAS) 2, 4, and 24 hours postoperatively.
timeFrame: 0-24 hours
measure: Both at rest and when swallowing 50 ml of water.
timeFrame: 0-24 hours
Secondary outcomes:
measure: Total amount of morphine and ketobemidone used 0-24 hours postoperatively.
timeFrame: 0-24 hours
measure: Nausea and vomiting 2, 4, and 24 hours postoperatively.
timeFrame: 0-24 hours
measure: Dizziness and sedation 2, 4, and 24 hours postoperatively.
timeFrame: 0-24 hours
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Department of Day Case Surgery at Glostrup University Hospital
Study officials:
affiliation: Department of Anaesthesiology, Copenhagen University Hospital in Glostrup, 2600 Glostrup, Denmark
name: Ole Mathiesen, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04305847: Satisfaction Assessment After Axillary Block
Official title: Satisfaction Assessment After Axillary Brachial Plexus Block for Distal Arm Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Satisfaction, Patient
Keywords: Anaesthesia, regional
axillary brachial plexus block
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2020-03-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients for whom distal arm surgery was performed under Axillary Brachial Plexus Block in a single university hospital

Brief summary: Satisfaction assessment at 24 and 48 hours post operatively, after Axillary Brachial Plexus Block for Distal Arm Surgery.

Detailed description: Inclusion after distal Arm Surgery performed under Axillary Brachial Plexus Block.

Satisfaction assessment at 24 and 48 hours post operatively by self-administered survey questionnaire based on different scales: Evan-LR, Net Promotor Score, Satisfaction score.

Eligibility criteria: Inclusion Criteria:

* patients for whom distal arm surgery was performed under Axillary Brachial Plexus Block

Exclusion Criteria:

* Refusal, inability to consent
* inability to fill self-administered survey questionnaire
* pregnancy and breastfeeding
* surgery \> 2 hours
* second surgical site requiring anaesthesia or analgesia
* chronic use of analgesia (including opioids) or illegal drugs

Primary outcomes:
measure: Evan-LR score on day 2
timeFrame: at 48 hours postoperative
Secondary outcomes:
measure: Evan-LR score on day 1
timeFrame: at 24 hours postoperative
measure: Net Promotor score on day 2
timeFrame: at 48 hours postoperative
measure: Net Promotor score on day 1
timeFrame: at 24 hours postoperative
measure: Patient Satisfaction score on day 2
timeFrame: at 48 hours postoperative
measure: Patient Satisfaction score on day 1
timeFrame: at 24 hours postoperative
Other outcomes:
Locations:
city: Besancon
country: France
facility: CHU de Besançon
Study officials:
References:
Clinical trial NCT03186547: Satisfaction Of Adult Patients With Gummy Smile Treated By Botulinum Toxin A Injection
Official title: Satisfaction Of Adult Patients With Gummy Smile Treated By Botulinum Toxin A Injection Versus Modified Lip Repositioning Surgery : A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Gummy Smile Due to Hypermobile Upper Lip
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the proposal study is to answer the question of how to manage gummy smiles due to hypermobile upper lip with less invasive and low risk level procedure . This trial will help the practitioners and the patients in taking the convenient decision to correct the gumminess to restore lip-gingival-dental harmony and enhance smile asthetics.

Detailed description: In this randomized clinical trial , two groups will be included to compare the effectiveness of a treatment modality of botulinum toxin-A injection , in the first group , on gingival display during smiling ,patient satisfaction , lower face esthetics ( upper lip length , upper lip vermillion length , interlabial gap , nasolabial angle) and the postoperative side effects . the comparator group will receive treatment by modified lip repositioning surgery ,to compare the results of the intervention group that can possibly obtained without undergoing surgery.

Eligibility criteria: Inclusion Criteria:

* Adults with age range from 18 - 30 years.
* Excessive gingival display more than 3 mm during smiling.
* Patients having hypermobile upper lip with or without (mild / moderate) vertical maxillary excess.
* Patients with normal morphology of clinical crowns.
* Normal lip separation (ILG) at rest
* Medically free subjects.

Exclusion Criteria:

* Patients with systemic diseases or neuromuscular disorders.
* Gummy smile with gingival display more than 8 mm during smiling.
* Severly long face (VME) patients.
* Patients with periodontal disease or gingival hyperplasia .
* Medically compromised patients contraindicated for surgery .
* Pregnant or lactating female patients.
* Patients with inadequate attached gingiva .

Primary outcomes:
measure: Patient satisfaction and postoperative side effects
timeFrame: at 4 weeks
Secondary outcomes:
measure: Improvement of gingival display upon smiling
timeFrame: at 4,8 and 12 weeks
measure: Lower face esthatics: a) upper lip length b) upper lip- vermillion length c) interlabial gap
timeFrame: at 4,8 and 12 weeks
measure: Lower face esthatics: d)nasolabial angle
timeFrame: at 4,8 and 12 weeks
measure: stability of gummy smile correction.
timeFrame: at the end of 24 weeks.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00642447: Helium:Oxygen Noninvasive Positive Pressure Ventilation in Patients Exposed to Sulfur Mustard
Official title: Helium:Oxygen Versus Air:Oxygen Nonivasive Positive Pressure Ventilation in Patients Exposed to Sulfur Mustard
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Bronchiolitis
Chronic Bronchitis
Keywords: noninvasive ventilation
helium
oxygen
sulfur mustard
chronic bronchitis
bronchiolitis
Lead sponsor: Baqiyatallah Medical Sciences University
Sponsor class: OTHER
First posted: 2008-03-25
Enrollment: 23
Sex: MALE
Minimum age (years): 38
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: to assess the effect of Heliox with Noninvasive positive pressure ventilation to decrease dyspnea and improve physiologic and respiratory measures in patients with a previous exposure to Sulfur Mustard gas.


Eligibility criteria: Inclusion Criteria:

* exposure to sulfur mustard
* worsening dyspnea during the last 10 days
* respiratory rate of \>25/min
* arterial pH\<7.35
* PaCO2 of \>50 mmHg
* PaO2 of \<50 mmHg

Exclusion Criteria:

* recent pneumothorax (\<1 month)
* severe respiratory failure or hemodynamic instability with forthcoming intubation
* FIO2 of \<0.4
* impaired consciousness or absence of patient cooperation
* facial lesions precluding NIPPV

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: BMSU
Study officials:
References:
Clinical trial NCT02120547: Phase 1 Study of Multiple-Dose Pharmacokinetics of Cenicriviroc in Subjects With Mild and Moderate Hepatic Impairment
Official title: An Open Label, Phase 1 Study to Evaluate the Effect of Mile and Moderate Hepatic Impairment on the Multiple-Dose Pharmacokinetics of Cenicriviroc (CVC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Liver Insufficiency
Keywords: Liver Insufficiency
Hepatic impairment
Lead sponsor: Tobira Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2014-04-22
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: To determine whether CVC exposures are altered in subjects with impaired hepatic function, compared to subjects with normal hepatic function. The results will help guide the clinical use of CVC in patients with hepatic impairment, determine the extent of PK changes, if any, and identify the potential need for dose adjustments of CVC in this population.


Eligibility criteria: Inclusion Criteria:

* Males and non-pregnant, non-lactating females aged 18-65
* Weight ≥ 50.0 kg
* BMI 18.0 - 40.0 kg/m2
* Able to participate, and willing to give written informed consent and to comply with the study restrictions
* Subjects with hepatic impairment will have stable liver disease (Child Pugh A or Child Pugh B)

Exclusion Criteria:

* Pregnant or lactating women and male partners of women who are pregnant or lactating
* Uncontrolled treated or untreated hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 105 mmHg)
* QTcF \> 450 msec for males and \> 470 msec for females at Screening or Day -1
* Donation or loss of blood over 350 mL within 60 days prior to screening
* Any evidence of progressive liver disease within the last 4 weeks for subjects with hepatic impairment

Primary outcomes:
measure: Multiple-dose pharmacokinetics of CVC
timeFrame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours postdose on Days 1 and 14
Secondary outcomes:
measure: Safety and tolerability
timeFrame: Days 1 through 35 for hepatic impaired subjects and Days 1-28 for healthy matching subjects
Other outcomes:
measure: Pro-inflammatory cytokines and biomarkers of bacterial translocation
timeFrame: 28 days after receiving first dose of study drug
Locations:
city: Fort Lauderdale
country: United States
facility: Clinical Pharmacology of Miami, Inc.
state: Florida
Study officials:
affiliation: Clinical Pharmacology of Miami, Inc.
name: Kenneth C Lasseter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02172547: Effect of Spiriva® on Health-related Quality of Life in Chronic Obstructive Pulmonary Disease (COPD) Patients Who Stopped Smoking During Treatment.
Official title: Effect of Spiriva® 18 Microgram on Health-related Quality of Life in COPD Patients Who Stopped Smoking During Treatment.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-06-24
Enrollment: 10821
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: General Practioner

Brief summary: Post marketing Surveillance to gain insights into the effects of therapy with Spiriva® (tiotropium bromide) on health-related quality of life in COPD patients who stopped smoking during treatment and to obtain safety data regarding adverse events.


Eligibility criteria: Inclusion Criteria:

* Patients with COPD
* Smoker at start

Exclusion Criteria:

* Patients presenting with any general and specific contraindications listed in the Patient Information Leaflet ('Gebrauchsinformation') and the Basic Product Information('Fachinformation')

Primary outcomes:
measure: Changes in health related quality of life
timeFrame: 6 weeks
Secondary outcomes:
measure: Occurrence of Adverse events
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03837847: Mechanistic Effects of Health Coaching to Reduce Chronic Obstructive Pulmonary Disease (COPD) Hospitalizations
Official title: Mechanistic Effects of Health Coaching to Reduce COPD Hospitalizations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Emphysema
Keywords: Health coaching
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2019-02-12
Enrollment: 63
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control wait design
Primary purpose: TREATMENT

Brief summary: The researchers are trying to explore the benefit of Health Coaching on patients with severe symptoms of COPD.


Eligibility criteria: Inclusion Criteria: Men and women 40 years or older with a clinical diagnosis of COPD with shortness of breath.

Exclusion: terminal illness, inability to communicate by phone

Primary outcomes:
measure: Change in Chronic Respiratory Questionnaire (CRQ) Dyspnea Score
timeFrame: Baseline, 3 months
measure: Change in Chronic Respiratory Questionnaire (CRQ) Fatigue Score
timeFrame: Baseline, 3 months
measure: Change in Chronic Respiratory Questionnaire (CRQ) Mastery Score
timeFrame: Baseline, 3 months
measure: Change in Chronic Respiratory Questionnaire (CRQ) Emotions Score
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: Change in Daily Physical Activity
timeFrame: Baseline,3 months
measure: Change in Self Management
timeFrame: Baseline, 3 months
measure: Change in Meaning in Life Questionnaire (MLQ) - Presence of Meaning
timeFrame: Baseline, 3 months
measure: Change in Meaning in Life Questionnaire (MLQ) - Search for Meaning
timeFrame: Baseline, 3 months
measure: Change in Depression
timeFrame: Baseline, 3 months
measure: Change in Anxiety
timeFrame: Baseline,3 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Roberto P Benzo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01584947: Clinical Trials With a Local Anesthetic Lozenge for the Treatment of Chronic Oral Pain
Official title: Clinical Trials With a Local Anesthetic Lozenge for the Treatment of Oral Mucosal Pain in Burning Mouth Syndrome, Sjögrens Syndrome and Lichen Planus.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Chronic Pain
Keywords: Oral pain
Local anesthetic
Bupivacaine hydrochloride
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: Oracain II Aps
First posted: 2012-04-25
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of the project is to do a fase two trial, where the effect of a local anesthetic lozenge will be tested in regard to oral pain, dryness of the mouth, irregularity of taste as well as investigate a potential antiinflammatory effect in patients with burning mouth syndrome, Sjögrens syndrome and lichen planus.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with burning mouth syndrome, Sjögrens syndrome or lichen planus
* All fertile women need to use save contraception
* Age between 18 and 75 years
* Able to speak, read and understand the danish language
* Must be informed orally and release a written consent and a signed authorization statement

Exclusion Criteria:

* Pregnant or breastfeeding women
* Known allergy to bupivacaine or other local anesthetics of the amide type
* Active infection which requires antibiotic treatment
* Patients in immune suppressive treatment

Primary outcomes:
measure: Assessment of oral pain on the Visual Analog Scale
timeFrame: The patients assess their oral pain when they attend the four examinations and they fill in a diary for a total of four weeks.
Secondary outcomes:
measure: Measure the inflammation markers in blood, saliva and tissue
timeFrame: Blood- and saliva samples are taken the four times the patient attend the examinations. They are taken over a periode of five weeks. Tissue samples are taken before the first treatment period starts and when the final treatment period is finished.
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Odontology, University of Copenhagen
Study officials:
affiliation: Department of Odontology, University of Copenhagen
name: Anne Marie L Pedersen, Ph.d.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06872047: Exploring the Knowledge, Attitudes, Behaviors and Perceived Barriers of Hepatologists Towards Non-invasive Hepatocellular Carcinoma Prediction Models in Hepatitis C Patients Who Achieved Sustained Virological Response Following Direct Acting Antivirals Therapy
Official title: Exploring the Knowledge, Attitudes, Behaviors and Perceived Barriers of Hepatologists Towards Non-invasive Hepatocellular Carcinoma Prediction Models in Hepatitis C Patients Who Achieved Sustained Virological Response Following Direct Acting Antivirals Therapy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Non-invasive Hepatocellular Carcinoma
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-03-12
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Practicing hepatologists involved in the management of HCV patients.

Brief summary: This study aims to assess the knowledge, attitudes, and behaviors (KAB) of hepatologists regarding different models used to predict hepatocellular carcinoma (HCC) in patients with chronic hepatitis C (HCV) who achieved sustained virological response (SVR) after direct-acting antiviral (DAA) therapy. The study will use a structured questionnaire targeting hepatologists globally to evaluate their familiarity with, confidence in, and clinical application of various predictive models. The primary outcome is the proportion of hepatologists who incorporate prediction models in clinical practice, while secondary outcomes include the level of knowledge about different models, perceived reliability, and barriers to their implementation the aim of the study 1) To evaluate the level of knowledge among hepatologists regarding existing HCC prediction models for post-SVR HCV patients.

2) To assess hepatologists' attitudes toward the utility, reliability, and clinical value of these models.

3) To identify the extent to which hepatologists incorporate predictive models into their clinical decision-making.

4) To determine perceived barriers to the adoption of these models in clinical practice.

5) To explore the factors associated with poor adoption of these predictive models.


Eligibility criteria: Inclusion Criteria:

* Hepatologists with at least one year of experience in managing HCV patients

Exclusion Criteria:

* Non-hepatologists, general practitioners, or respondents who submit incomplete surveys

Primary outcomes:
measure: percentage of hepatologists who use HCC prediction models in clinical practice.
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: