louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03003624: Comparing the Outcomes of Incisions Made by Colorado® Microdissection Needle
Official title: Comparing the Outcomes Of Incisions Made By Colorado® Microdissection Needle, Electrosurgery Tip And Surgical Blade During Periodontal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Periodontitis
Keywords: Incisions
microdissection needle
Lead sponsor: SVS Institute of Dental Sciences
Sponsor class: OTHER
First posted: 2016-12-28
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 aim of the present study was to compare the outcomes of incisions made by Colorado® microdissection needle, electrosurgery tip and surgical blade during periodontal surgery.

Detailed description: Commercially, many microdissection needle systems are available, such as Stryker Colorado® microdissection needle (CMN) (Stryker-Leibinger, Freiburg, Germany) and optimicro™ microdissection needles. Colorado® microdissection needle (CMN) combine the advantages of scalpel and electrosurgery. CMN® was introduced into clinical practice in 1997, with a wide array of applications in the field of Ophthalmology, Neurosurgery, and others.

The primary feature of the Colorado® microdissection needle is the ultra-sharp tungsten tip that delivers the wave-form from the electrosurgery generator to a very small spot. This allows the use of extremely low wattages, resulting in less tissue necrosis, precision cutting and cautery, and less post-operative pain. The instrument tip is a delicately machined, insulated tungsten diathermy needle that is compatible with any standard cautery hand piece. Tungsten, with its extremely high melting point (\>3400°C) provides a heat resistant tip that maintains sharpness compared to stainless steel tips that dull rapidly.

Eligibility criteria: Inclusion Criteria:

* Systemically healthy individuals within the age group of 25-45 years having at least 20 teeth remaining in the mouth of which at least 4 teeth in each quadrant requiring periodontal surgery, patients with periodontal pockets with ≥5 mm in depth suitable for modified Widman flap were included in the study.

Exclusion Criteria:

* Patients who underwent periodontal therapy in the past 6 months, medically compromised patients, patients with poorly shielded cardiac pacemakers were excluded from the study.

Primary outcomes:
measure: Quantity of blood loss in ml
timeFrame: Immediate postoperative volume
measure: PPD in mm
timeFrame: Baseline to 180 days
measure: Changes in dimensions of interdental papilla in mm
timeFrame: Baseline to 180 days
Secondary outcomes:
measure: Assessment of postoperative pain:
timeFrame: 1 day, 7 & 15 days
measure: Assessment of wound healing:
timeFrame: 1 day, 7 & 15 days
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: SVS Institute of Dental Sciences, Mahabubnagar
state: Andhra Pradesh
Study officials:
References:
Clinical trial NCT05863624: Open and Endoscopic Technique in Female Inguinal Hernia Repair. FemaleHernia
Official title: Postoperative Pain and Recurrences After Totally Extraperitoneal Endoscopic (TEP) vs. Lichtenstein Hernioplasty in Female Inguinal Hernia Repair: a Prospective Randomized Multi-center Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Post Operative Pain
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
Collaborators: name: Helsinki University Central Hospital
name: Päijänne Tavastia Central Hospital
name: North Karelia Central Hospital
name: Jyväskylä Central Hospital
name: Mikkeli Central Hospital
First posted: 2023-05-18
Enrollment: 170
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized follow-up study
Primary purpose: TREATMENT

Brief summary: This randomized study compares open inguinal hernia repair (Lichtenstein hernioplasty) to endoscopic repair (TEP) in terms of chronic pain and recurrences in one and five years after operation.

Detailed description: The best operative technique in female inguinal hernia is not known. Some register studies recommend always laparoscopic hernia repair in females, but there are no randomized studies to show that laparoscopic repair is better than open hernioplasty. Our study compares operative complications, chronic pain and recurrences in Lichtenstein operation to totally endoscopic hernia repair (TEP) in 170 female patients with primary inguinal hernia. The patients are operated in six Finnish hospitals, randomized into 85 Lichtenstein vs 85 TEP and followed 1 week, 4 weeks, 12 months and 5 years. Main end-point in postoperative pain after one year, sencondary endpoints are sick leave, return to normal physical activity, complications of treatment, re-operations, chronic pain and costs of treatment.

Eligibility criteria: Inclusion Criteria:

* primary inguinal hernia in females

Exclusion Criteria:

* emergency operation
* recurrent hernia
* groin pain without hernia
* frail and sick patient ASA ≥ 4

Primary outcomes:
measure: Chronic pain
timeFrame: from 1 week to one year
Secondary outcomes:
measure: Complications
timeFrame: 1 month
measure: Recurrence
timeFrame: 5 years
measure: Sick leave
timeFrame: 0-30 days
measure: Treatment costs
timeFrame: 0-30 days
Other outcomes:
Locations:
city: Mikkeli
country: Finland
facility: Mikkeli Central Hospital
Study officials:
References:
Clinical trial NCT00121524: Effects of Epinephrine and Intravenous (I.V.) Needle on Cardiopulmonary Resuscitation (CPR) Outcome
Official title: Effects of Epinephrine and I.V. Needle on CPR Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cardiac Arrest
Keywords: cardiac arrest
resuscitation
epinephrine
intravenous
survival
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: Laerdal Medical
name: Ullevaal University Hospital
name: Health Region East, Norway
name: Norwegian Air Ambulance Foundation
name: University of Oslo
First posted: 2005-07-21
Enrollment: 904
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: Intravenous epinephrine has been part of the guidelines for cardiopulmonary resuscitation since the start. It improves outcome in animal studies, but has never been investigated in a controlled study in humans. Epidemiologic data indicate that it is an independent negative predictor for survival. If this is true in a controlled randomized study, it could be due to effects of the drug itself or more likely due to reduced quality of chest compressions and ventilations due to the time spent on placing an I.V. needle and injecting drugs.

Detailed description: In a randomized, controlled study of all out-of-hospital cardiac arrest patients in Oslo, Norway, half the patients are treated according to the international guidelines for advanced CPR, and the other half according to the same guidelines, except for no I.V. needle or drugs are given until 5 minutes after eventual return of spontaneous circulation.

Eligibility criteria: Inclusion Criteria:

* Cardiac arrest out-of-hospital

Exclusion Criteria:

* \<18 years old
* Trauma as cause of arrest

Primary outcomes:
measure: survival to hospital discharge with neurologic outcome
timeFrame: discharge from hospital
Secondary outcomes:
measure: admit to hospital with spontaneous circulation
timeFrame: hospital admission
measure: one year survival with neurologic outcome
timeFrame: one year after hospital discharge
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Ulleval University Hospital
Study officials:
affiliation: Ullevaal University Hospital
name: Lars Wik, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Holmberg M, Holmberg S, Herlitz J. Low chance of survival among patients requiring adrenaline (epinephrine) or intubation after out-of-hospital cardiac arrest in Sweden. Resuscitation. 2002 Jul;54(1):37-45. doi: 10.1016/s0300-9572(02)00048-5.
citation: Olasveengen TM, Sunde K, Brunborg C, Thowsen J, Steen PA, Wik L. Intravenous drug administration during out-of-hospital cardiac arrest: a randomized trial. JAMA. 2009 Nov 25;302(20):2222-9. doi: 10.1001/jama.2009.1729.
Clinical trial NCT00956124: Autofluorescence in Uveitic and Diabetic Macular Edema
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Uveitis
Macular Edema
Lead sponsor: St. Franziskus Hospital
Sponsor class: OTHER
First posted: 2009-08-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with uveitis or diabetes

Brief summary: The aim of this study is to determine whether fundus autofluorescence and macular pigment distribution in inflammatory and diabetic macular edema are altered.

Detailed description: After macular pigment measuring we will perform fundus autofluorescence, fluorescein angiography and optical coherence tomography. any associations of macular pigment distribution and fundus autofluorescence with macular anatomic features are analyzed. primary outcome measure is the macular pigment distribution in patients with altered fundus autofluorescence. Furthermore we will compare the findings between diabetic and inflammatory edema.

Eligibility criteria: Inclusion Criteria:

* patients with diabetic or uveitis macular edema

Exclusion Criteria:

* children patients with known allergy to fluorescein

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: Department of Ophthalmology at St Franziskus Hospital
state: North-Rhine-Westfalia
Study officials:
References:
Clinical trial NCT00004424: Randomized Study of Propofol Versus Fentanyl and Midazolam in Pediatric Patients Requiring Mechanical Ventilation and Sedation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiration Disorders
Keywords: disease-related problem/condition
oncologic disorders
pulmonary complications
rare disease
Respiration, Artificial
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
Collaborators: name: Case Western Reserve University
First posted: 1999-10-19
Enrollment: 120
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

I. Assess the degree of amnesia afforded by study sedatives relative to the patient's intensive care unit experiences.

II. Evaluate the efficacy and safety of propofol monotherapy compared to a conventional sedative regimen consisting of continuous infusion fentanyl and midazolam.

III. Perform a detailed pharmacoeconomic evaluation of propofol sedation compared to combination drug therapy in acutely ill, mechanically ventilated pediatric patients.

Detailed description: PROTOCOL OUTLINE:

This is a randomized, double blind study.

Patients are randomized to receive either a continuous infusion of propofol or a continuous infusion combination of fentanyl and midazolam preceded by a loading dose. Sedative doses may be reduced if necessary. Treatment is continued until sedation is no longer needed, any other sedative therapy is administered, or unacceptable toxicity is experienced.

Patients are assessed after extubation, just prior to hospital discharge, and then every 2 months for 6 months after hospital discharge.

Eligibility criteria: * Patients admitted to the Rainbow Babies and Children's Hospital Pediatric Intensive Care Unit who require mechanical ventilation and sedation therapy
* Mean COMFORT score must be greater than 26 after 3 consecutive scores are obtained at 2 minute intervals over 6 minutes
* No other concurrent sedative therapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Case Western Reserve University
name: Michael Deneal Reed
role: STUDY_CHAIR
References:
Clinical trial NCT05264324: Maximal Exercise Capacity at 2500 m of High Altitude
Official title: The Impact of Hypoxia on Patients With Precapillary Pulmonary Hypertension and Treatment of Adverse Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Altitude Pulmonary Hypertension
Maximal Exercise Capacity
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2022-03-03
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Patients will be exposed to ambient air at 490m vs. hypoxic air at 2500m in a randomized sequence according to a cross-over design
Primary purpose: PREVENTION

Brief summary: The impact of hypoxia on maximal work rate during incremental ramp exercise within 3-6 hours after arriving at 2500m of high altitude in patients with precapillary pulmonary hypertension


Eligibility criteria: Inclusion Criteria:

* Informed consent as documented by signature (Appendix Informed Consent Form)
* PH class I (PAH) or IV (CTEPH) diagnosed according to guidelines: mean pulmonary artery pressure \>20 mmHg, pulmonary vascular resistance ≥3 wood units, pulmonary arterial wedge pressure ≤15 mmHg during baseline measures at the diagnostic right-heart catheterization

Exclusion Criteria:

* resting partial pressure of oxygen \<8 kilopascal at Zurich at 490 m low altitude
* exposure to an altitude \>1000 m for ≥3 nights during the last 2 weeks before the study
* inability to follow the procedures of the study
* other clinically significant concomitant end-stage disease (e.g., renal failure, hepatic dysfunction)

Primary outcomes:
measure: Maximal work rate
timeFrame: 30 hours
Secondary outcomes:
measure: Heart rate
timeFrame: 30 hours
measure: Ventilation
timeFrame: 30 hours
measure: Oxygen uptake
timeFrame: 30 hours
measure: Arterial blood oxygenation saturation
timeFrame: 30 hours
measure: Blood gases
timeFrame: 30 hours
measure: Hemodynamics
timeFrame: 30 hours
measure: Borg dyspnoea and leg fatigue scale
timeFrame: 30 hours
measure: Visual Analogue Scale for dyspnea
timeFrame: 30 hours
measure: Electro cardiography
timeFrame: 30 hours
measure: Electro cardiography :ST-segment changes
timeFrame: 30 hours
measure: Electro cardiography: ST-segment changes under oxygen
timeFrame: 30 hours
measure: Electro cardiography: Clinically relevant ischemia
timeFrame: 30 hour
measure: Electro cardiography: QT-Interval
timeFrame: 30 hours
measure: Electro cardiography: QT-Interval
timeFrame: 30 hours
measure: Electro cardiography: PQ-Interval
timeFrame: 30 hours
measure: Rate pressure product
timeFrame: 30 hours
measure: Electro cardiography: Cardiac arrhythmia
timeFrame: 30 hours
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Respiratory Clinic, University Hospital of Zurich
Study officials:
References:
Clinical trial NCT02743624: Criteria Analysis for Ventilatory Support Adjustment of Mechanical Ventilation
Official title: Criteria Analysis for Ventilatory Support Adjustment of Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Mechanical Ventilatory Failure
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2016-04-19
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The indications for mechanical ventilation (MV) include excessive work of breathing, with or without evidence of respiratory muscle fatigue. The setting of the MV is still a challenge because it is based on criteria understudied, often subjective and observer-dependent. Despite several studies, to our knowledge has never been done before is the precise definition of the optimal range of ventilatory support. Novel and recognizable diagnostic techniques will be applied. No single parameter of the breathing pattern has good accuracy for the adjustment of ventilatory support. Non-invasive measures such as P0.1 and rate of muscle relaxation may have good accuracy for the adjustment of ventilatory support.

Detailed description: Use of excessive pressure support

Eligibility criteria: Inclusion Criteria:

* patients under invasive mechanical ventilation for 48h
* patients without the objective of complete rest of the respiratory muscles. This decision will be on the discretion of the attending physician,
* spontaneous breathing,
* clinically stability.

Exclusion Criteria:

* Previous disease of the central nervous system that can lead to respiratory changes.
* Previous disease of the peripheral nervous system that can lead to respiratory changes
* Previous muscular disease.

Primary outcomes:
measure: Measuring muscular force
timeFrame: From the baseline ventilation to the minimum level of pressure support. Around 3 hours
Secondary outcomes:
measure: Measuring inspiratory drive
timeFrame: From the baseline ventilation to the minimum level of pressure support. Around 3 hours
measure: Measuring endurance
timeFrame: From the baseline ventilation to the minimum level of pressure support. Around 3 hours
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hearth Institute - University of Sao Paulo
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital Clinicas Sao Paulo
Study officials:
affiliation: University of Sao Paulo
name: Carlos Carvalho
role: STUDY_DIRECTOR
References:
Clinical trial NCT03080324: Sublingual Versus Endovenous Fentanyl for Pain Treatment in Trauma Patients in the Emergency Room
Official title: Sublingual Versus Endovenous Fentanyl for Pain Treatment in Trauma Patients in the ER - a Double-blind Randomized Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Pain Due to Trauma
Keywords: Fentanyl
Transmucosal administration
Endovenous administration
Pain therapy
Lead sponsor: Azienda Sanitaria dell'Alto Adige
Sponsor class: OTHER
First posted: 2017-03-15
Enrollment: 108
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: The purpose of this study is to determine the non-inferiority of the efficacy of sublingual given fentanyl versus endovenous given fentanyl for patients in the emergency departement.

Detailed description: Fentanyl endovenous (ev) is an excellent analgesic drug for pain relief in acute traumatic pain. Fentanyl sublingual (Abstral ®) is an excellent analgesic drug in the breakthrough pain relief in oncologic patients.

The immediate (10 minutes) effect and the ease of administration of sublingual fentanyl could be a possibility for a fast pain relief in remote areas such as mountain rescue missions.

Patients will be recruited according to a randomized list to fentanyl ev or fentanyl sublingual versus placebo oral or placebo ev.

Safety issues like control of vital signs will be warranted

Eligibility criteria: Inclusion Criteria:

* Trauma on the limbs with a pain score of 4 or more
* ASA I - II

Exclusion Criteria:

* children \< 18 years
* cognitive impairment: brain injury, intoxication, analgesia
* weight under 50 kg and more then 100 kg
* other injuries like chest trauma with respiratory insufficiency, suspect liver or spleen injury, amputation;
* chronic analgesic use or misuse
* allergy
* fear of needles
* pregnancy
* speech difficulties

Primary outcomes:
measure: Pain - Relief
timeFrame: 1 hour
Secondary outcomes:
measure: Practicability / handling of the two dosage forms of fentanyl in emergencies
timeFrame: 1 hour
measure: Patient comfort
timeFrame: 1 hour
measure: Adverse drug effects
timeFrame: 1 hour
measure: SpO2 (%)
timeFrame: 1 hour
Other outcomes:
Locations:
city: Bruneck
country: Italy
facility: Emergency Room of Bruneck Regional Hospital
Study officials:
affiliation: Südtiroeler Sanitätsbetrieb
name: Elisabeth Gruber, MG MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03145324: Immunisation History Survey - a Study to Measure Levels of Immunity to Routine Immunisations
Official title: Immunisation History Survey - a Study to Measure Levels of Immunity to Routine Immunisations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Immunization; Infection
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2017-05-09
Enrollment: 166
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants enrolled in a previous vaccine study (REC 09/H0604/107)

Brief summary: To collect the immunisation history of participants enrolled in a previous vaccine study (REC 09/H0604/107) in order to assess the influence of genetic variation on the level of immunity to routine immunisations.

Detailed description: Children aged 6 month to 13 years were enrolled in a study to compare the immunogenicity and safety of adjuvanted or non-adjuvanted influenza vaccines during the 2009 pandemic influenza season. Nine-hundred and forty-nine children were recruited from 5 UK centres: Oxford, Southampton, Bristol, Exeter, and London

In the previous study, DNA was collected when individuals provided appropriate consent, to explore the genetic determinants of responses to vaccination. Although, study participants consented for their medical records to be reviewed by members of the study team, and for these data as well as anonymised serum samples to be used in future research, routine immunisation histories were not collected before this study closed.

In this study we wish to collect the full vaccination history of participants, as this information will be extremely important in interpreting results. We propose sending a letter to parents/guardians informing them of the study and asking whether they are willing for members of the study team to approach their general practitioner or the child health computer system in order to retrieve these records. Immunisation histories will then be included with other non-identifiable information needed for analysis, and samples unlinked from personal identifiers prior to analysis.

Eligibility criteria: Inclusion Criteria:

* The inclusion criteria are consent in the original vaccine study (09/H0604/107) with explicit consent for samples to be stored and used in future research as well as consent to this subsequent study

Exclusion Criteria:

* Individuals who do not have explicit consent for samples taken in the original vaccine study (09/H0604/107) to be stored for future research.
* Individuals who have not been consented into this study

Primary outcomes:
measure: The primary endpoint will be the completion of the collection of vaccination histories from consented participants.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Centre for Clinical Vaccinology & Tropical Medicine (CCVTM)
state: Oxfordshire
Study officials:
affiliation: University of Oxford
name: Andrew Pollard Pollard, PhD
role: PRINCIPAL_INVESTIGATOR
References: