louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00645723: Intravenous Colistin Versus Intravenous Colistin Plus Nebulized Colistin in VAP Due MDR Acinetobacter Baumannii
Official title: Phase 3b Randomized Double Blind Controled Placebo Comparative Trial of Intravenous Colistin vs Intravenous Colistin Plus Nebulized Colistin in Patients With Ventilator-associated Pneumonia (VAP) Due Multiresistant Acinetobacter Baumanii
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cross Infection
Pneumonia, Bacterial
Keywords: Acinetobacter baumanii
Ventilator-associated pneumonia
Lead sponsor: Hospitales Universitarios Virgen del Rocío
Sponsor class: OTHER
First posted: 2008-03-28
Enrollment: 67
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: Compare the clinical efficiency evaluated by the treatment of the intravenous colistin plus inhaled colistin opposite to the treatment with colistin intravenous plus inhaled saline solution in patients with VAP due to baumannii carbapenems resistant.

Detailed description: Compare the clinical efficiency evaluated by the treatment of the intravenous colistin plus inhaled colistin opposite to the treatment with colistin intravenous plus inhaled saline solution in patients with VAP due to baumannii carbapenems resistant.

Eligibility criteria: Inclusion Criteria:

* Diagnose of VAP due A. baumannii or A. baumannii and another microorganism carbapenems resistant.
* Clinical Pulmonary Infection Score (CPIS) \> 6

Exclusion Criteria:

* Allergy to colistin.
* Asthma
* Shock status
* Diagnose of VAP due A. baumannii colistin resistant.

Primary outcomes:
measure: Compare the clinical efficiency evaluated by the treatment of the intravenous colistin plus inhaled colistin opposite to the treatment with colistin intravenous plus inhaled saline solution in patients with VAP due to baumannii carbapenems resistant
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Seville
country: Spain
facility: Hospital Universitario Virgen del Rocío
Study officials:
References:
Clinical trial NCT04185623: Time Lag for Oocyte Denudation: A Better Choice for ICSI Outcome?!
Official title: Time Lag for Oocyte Denudation:Is it a Better Choice for ICSI Outcome?!
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility, Female
Keywords: denudation timing ICSI timing oocyte aging
Lead sponsor: Benha University
Sponsor class: OTHER
Collaborators: name: Hawaa Fertility Center
First posted: 2019-12-04
Enrollment: 300
Sex: FEMALE
Minimum age (years): 24
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: couples who came seeking fertility through our IVF center

Brief summary: This study aiming to investigate if difference in the timing of cumulus removal post retrieval would have any critical impact on fertilization and embryonic development.

Detailed description: Patients under 37 year old who were treated with controlled ovarian stimulation for ICSI were randomly divided into 2 groups; Group A: Oocytes were denudated immediately after oocyte retrieval , Group B: Oocytes were denudated 2 hours after retrieval and both groups were microinjected at 4 hours from ovum pickup. Microinjection was performed on all matured oocytes only and they were cultured to blastocyst stage.The rates of maturation, fertilization, good quality blastulation, chemical pregnancy and clinical pregnancy were analysed and compared between the two groups.

Eligibility criteria: Inclusion Criteria:

* Women 24-37 years old
* With good ovarian reserve
* Induction using Long agonist protocol
* unexplained infertility

Exclusion Criteria:

* severe male factor
* Testicular samples for ICSI
* poor ovarian reserve
* no of oocytes collected less than 4

Primary outcomes:
measure: Day 5, good quality blastocyst
timeFrame: 120 hour post ovum pickup
Secondary outcomes:
measure: clinical pregnancy
timeFrame: 6 weeks from the last normal menstrual period
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Hawaa Fertility Center
state: Qalyubiya
Study officials:
References:
Clinical trial NCT00600223: Functional Voice and Speech Outcomes Following Surgical Voice Restorations: A Comparison of Pharyngeal Construction Approaches
Official title: Functional Voice and Speech Outcomes Following Surgical Voice Restorations: A Comparison of Pharyngeal Reconstruction Approaches
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Larynx Cancer
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Massachusetts Eye and Ear Infirmary
name: Brigham and Women's Hospital
First posted: 2008-01-24
Enrollment: 5
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: MSKCC clinic

Brief summary: The purpose of this study is to evaluate the nature and quality of speech after removal of the voice box and all or part of the swallowing tube.

The study is evaluating which type of surgery provides patients with the best speech and voice.

These data will be used to help surgeons to design better ways to restore voice function after removal of the voice box. Information about disease, its treatment, quality of life, and physical and vocal function will be collected. An audio recording of vocal tasks will also be done. All of this information will be analyzed and the two different subject groups will be compared to see if there are differences.


Eligibility criteria: Inclusion Criteria:

* Subjects who have undergone removal of the larynx and the entire pharynx by either traditional reconstruction or more advanced reconstructive techniques, which involve the use of tissue, such as skin or bowel, from other parts of the body. There is no time frame for reconstruction. All subjects who have previously undergone reconstruction are eligible.
* Subjects who use the tracheoesophageal puncture method of voice restoration as their primary communication technique.
* \> or equal to 18 years old

Exclusion Criteria:

* Do not have functional voice restoration.
* Do not speak English as a functional language.

Primary outcomes:
measure: Determine the pertinent differences in objective and subjective voice parameters between PR techniques, specifically comparing those techniques that provide mucosal lining (jejunum) to those with cutaneous lining (radial forearm flap).
timeFrame: conclusion of study
Secondary outcomes:
measure: Provide physician with meaningful and relevant data upon which to base the optimal choice of pharyngeal reconstruction method for individual patients who must undergo laryngectomy with pharyngeal reconstruction for the treatment of carcinoma.
timeFrame: conclusion of study
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Dennis Kraus, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04925323: A DERMO-EPIDERMAL AUTOLOGOUS SKIN SUBSTITUTE FOR FURTHER THERAPEUTIC USE
Official title: VALIDATION OF A GMP-COMPLIANT BIOPRINTING PROCESS FOR MANUFACTURING A DERMO-EPIDERMAL AUTOLOGOUS SKIN SUBSTITUTE FOR FURTHER THERAPEUTIC USE
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Plastic Surgeries
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2021-06-14
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Innovative technologies in the emerging field of regenerative medicine might allow an improvement in the treatment of deep complex wounds leading to faster and better wound healing. Among them, the bioprinting technology, consisting in "printing human cells and biomaterials" to create a "dermo-epidermal substitute" that mimics an alternative of the physiological skin is the most promising alternative.

Besides improving skin substitutes properties, bioprinting allows to translate the manufacturing process of tissue-engineered products from manual, operator-dependent processes to a reproducible and automated solution. This paves the way to the manufacturing of therapeutic bioprinted products at the point of care, as close as possible from patients.

Detailed description: In this preclinical in vitro study, the investigators plan to generate GMP-compliant validation batches of "bio-printed dermo-epidermal substitutes" from 25 healthy volunteer patients' unused surgical tissue removed during plastic surgeries.

Volunteer's harvested tissue will allow to extract and then amplify the epidermal keratinocytes and dermal fibroblasts. Successive cultures and bioprinting steps will generate a "bio-printed dermo-epidermal substitute" in 2 or 3 weeks. A blood test may also be performed on the volunteers to characterize the genetic stability during the different stages of the process.

Eligibility criteria: Inclusion Criteria:

* Adult adult males or females
* Members of a social security scheme.
* No contraindications to general anesthesia
* Relevant to a plastic or repair surgery indication generating surgical waste.

Exclusion Criteria:

* Pregnant and/or nursing women
* Persons deprived of liberty
* Major under guardianship
* Persons unable to read the backgrounder.

Primary outcomes:
measure: bioprinted dermo epidermal substitute sterility assessment
timeFrame: 24 MONTHS
measure: Population Doubling Rate of keratinocytes
timeFrame: 24 MONTHS
measure: Population Doubling Rate of fibroblasts
timeFrame: 24MONTHS
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: assistance publique hôpitaux de Marseille
Study officials:
affiliation: AP HM
name: jean-olivier ARNAUD
role: STUDY_DIRECTOR
affiliation: AP HM
name: Dominique CASANOVA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02441023: Nutritional Therapy and Education With Multimedia Application in Patients With Type 2 Diabetes
Official title: Nutritional Therapy and Education With a Multimedia Application in the Metabolic Control of Patients With Type 2 Diabetes. Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: type 2 diabetes mellitus
nutritional therapy
health education
self-management
multimedia
Lead sponsor: Coordinación de Investigación en Salud, Mexico
Sponsor class: OTHER_GOV
Collaborators: name: National Council of Science and Technology, Mexico
First posted: 2015-05-12
Enrollment: 306
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
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 evaluate the effectiveness of nutrition therapy in combination with education in diabetes using a multimedia application for improving indicators of metabolic control in patients with type 2 diabetes.

Detailed description: Randomized clinical trial. Subjects with type 2 diabetes from three Family Medicine Units (primary care), with HbA1c \>6.5% and \<13.0%, without advanced macro or microvascular complications of diabetes.

Two arms: the experimental group with nutrition therapy plus education in diabetes through a multimedia application. The application had seven modules: Introduction, nutrition, physical exercise in diabetes, myths and truths on diabetes, metabolic control parameters, knowing diabetes, complications of diabetes. The control group received only usual nutrition therapy.

A monthly follow up during the first 7 months and then bimonthly, until 21 months of total follow up, with reinforcement in each visit of nutrition and other non-pharmacological therapy, with control on weight and blood pressure. Laboratory studies included HbA1c, lipids profile, creatinine and albuminuria, performed at 7, 14 and 21 months. Results were provided to both the patient and his family physician, so modification in drug treatment if needed, were performed.

Eligibility criteria: Inclusion criteria:

* Diagnosis of type 2 diabetes, following ADA \& WHO criteria
* Without severe marco or microvascular complications of diabetes
* HbA1c \> 6.5% and \<13.0%

Exclusion criteria:

* Inability to or unwillnigness to access the multimedia or to follow dietary recommendations

Primary outcomes:
measure: Metabolic control
timeFrame: 21 months
Secondary outcomes:
measure: Lipids profile
timeFrame: 21 months
measure: Body mass index (BMI)
timeFrame: 21 months
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Unidad de Investigación en Epidemiología Clínica, Hospital Regional 1 Carlos Mac Gregor Sanchez Navarro, IMSS
state: Distrito Federal
Study officials:
affiliation: Unidad de Investigación en Epidemiología Clínica, Hospital Regional Carlos Mac Gregor Sanchez Navarro, IMSS
name: Lubia Velazquez, M. Sc.,
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04896723: Sexual Dysfunction in Patients With Chronic Liver Disease
Official title: Sexual Dysfunction in Patients With Chronic Liver Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Diseases
Liver Cirrhosis
Lead sponsor: King's College Hospital NHS Trust
Sponsor class: OTHER
First posted: 2021-05-21
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic liver disease

Brief summary: This project will determine the incidence of sexual dysfunction in patients with chronic liver disease, through questionnaires. The questionnaires have been designed to assess several facets of sexual health, e.g. libido, physical symptoms, depression, etc. 150 patients in our liver outpatient department, and 150 healthy volunteers will be asked to fill in the questionnaire in paper form. The results of this project will be used to produce patient resources, advice sheets and educational materials for patients with chronic liver disease. There is also scope to consider possible interventions in the future to improve sexual dysfunction in patients with chronic liver disease.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of a chronic liver disease (including those who have had liver transplantation)
* Aged 18-75
* Able to give informed written consent

Exclusion Criteria:

* Major psychiatric disease
* Patients who lack capacity
* Patient with no chronic liver disease
* Patients not proficient in English

Primary outcomes:
measure: Number of patients with sexual dysfunction
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Institute of Liver Studies
Study officials:
References:
Clinical trial NCT04255823: Efficacy of a Multi-faceted Intervention to Deprescribe Proton Pump Inhibitors (PPI) in Primary Care: a Population-based, Pragmatic, Cluster-randomized Controlled Trial.
Official title: Efficacy of a Multi-faceted Intervention to Deprescribe Proton Pump Inhibitors (PPI) in Primary Care: a Population-based, Pragmatic, Cluster-randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Proton Pump Inhibitors
Deprescription
Keywords: Proton pump inhibitors
Deprescription
Multi-faceted intervention
Patient-centered
Primary health care
Pharmacoepidemiology
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 34000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Deprescribing is defined as "the process of withdrawal of an inappropriate medication, supervised by a health care professional with the goal of managing the polypharmacy and improving outcomes". Inappropriate use of proton pump inhibitors (PPI) is associated with severe adverse drug reactions and a major economic impact. Deprescribing should be considered when inappropriate prescription of PPI is identified.

DeprescrIPP is a pragmatic population-based cluster-randomized trial conducted in primary care. It will assess the efficacy and effectiveness of a multi-faceted intervention (on patients and general practitioners) to deprescribe PPI.


Eligibility criteria: Inclusion Criteria:

* General practitioners (GPs):

  • All GPs settled in the 2 departments of Loire-Atlantique and Vendée with more than 100 patients in the year before baseline, will be eligible.
* Patients:

  * aged over 18 years
  * affiliated to the French health insurance system (CPAM)
  * treated with PPI with more than 300 DDD/year in the year before baseline, estimated with reimbursement databases.
  * whose GP is included in the study

Exclusion Criteria:

* General practitioners (GPs):

  • Participation refusal
* Patients :

  * Participation refusal
  * Patients at risk of gastroduodenal lesions i.e. treated with nonsteroidal anti-inflammatory drugs (NSAIDs) and over 65 years old or treated with either corticosteroids or anticoagulants or platelet aggregation inhibitors

Primary outcomes:
measure: PPI deprescribing
timeFrame: 12 months
Secondary outcomes:
measure: Cost-utility analysis
timeFrame: 12 months
measure: GERD symptoms recurrence
timeFrame: 12 months
measure: Attitudes of patients towards deprescribing
timeFrame: 12 months
Other outcomes:
Locations:
city: Nantes
country: France
facility: University Hospital
Study officials:
References:
citation: Nguyen-Soenen J, Rat C, Gaultier A, Schirr-Bonnans S, Tessier P, Fournier JP. Effectiveness of a multi-faceted intervention to deprescribe proton pump inhibitors in primary care: protocol for a population-based, pragmatic, cluster-randomized controlled trial. BMC Health Serv Res. 2022 Feb 17;22(1):219. doi: 10.1186/s12913-022-07496-3.
Clinical trial NCT05280223: Dexmedetomidine Versus Hyalase Treatment of Carpal Tunnel Syndrome
Official title: Dexmedetomidine Versus Hyalase Local Injection for Pain Alleviation in Patients With Carpal Tunnel Syndrome; A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Pain, Chronic
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-03-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Carpal tunnel syndrome (CTS) is a common peripheral entrapment neuropathy, this study aims to investigate if, and to what extent hydro-dissection hyalase and saline versus dexmedetomidine upon the median nerve could offer symptoms and clinical improvement

Detailed description: Carpal tunnel syndrome (CTS) is the most common compression syndrome the upper extremities. Its problem has a high prevalence ranged estimated prevalence of 3.8% in the general population, 3 and 7.8% in the working population. It occurs at any age, especially in individuals in their 40s to 60s, and the male: female ratio is reported to be 3:7. A lot of treatment modalities have been tried to improve the condition, starting from local anesthetic injection, steroid, and up to surgical decompression of the nerves.

Eligibility criteria: Inclusion Criteria:

* adult patients
* complaining of carpal tunnel syndrome of 3 month duration or more
* diagnosed axonal neuropathy using electrodiagnosis , nerve conduction study

Exclusion Criteria:

* • patient refusal infection at the site of intervention

  * local anesthetic allergy

Primary outcomes:
measure: Pain alleviation
timeFrame: 6 months
Secondary outcomes:
measure: Median nerve cross sectional area
timeFrame: 6 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Emad Zarief Kamel Said
Study officials:
References:
Clinical trial NCT02286323: Endotracheal Intubation During Resuscitation
Official title: Can the Bonfils Intubation Fiberscope Rival the Macintosh Laryngoscope During Resuscitation With Uninterrupted Chest Compression?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Arrest
Keywords: Intubation, Endotracheal
Lead sponsor: International Institute of Rescue Research and Education
Sponsor class: OTHER
First posted: 2014-11-07
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: We hypothesized that the BONFILS is beneficial for intubation of manikins while performing CPR. In the current study we compared the performance of the BONFILS and the Macintosh laryngoscopes with respect to their effectiveness and time to successful ETI during chest compression (CC) using an adult manikin.


Eligibility criteria: Inclusion Criteria:

* give voluntary consent to participate in the study
* minimum 1 year of work experience in emergency medicine
* experienced emergency medical personnel (paramedics, nurses, physicians)

Exclusion Criteria:

* not meet the above criteria
* wrist or low back diseases

Primary outcomes:
measure: Time to intubation
timeFrame: intraoperative
Secondary outcomes:
measure: Success of intubation
timeFrame: intraoperative
measure: POGO score
timeFrame: 1 day
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: International Institute of Rescue Research and Education
state: Masovia
Study officials:
affiliation: Institute of Cardiology
name: Andrzej Kurowski
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05069350: Bupivacaine vs Oxybuprocaine Topical Anesthesia in IVI
Official title: A Double Blinded Randomized Controlled Study of Topical Anaesthetics Oxybuprocaine Versus Bupivacaine 0.5% in Intravitreal Injections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Pain, Acute
Lead sponsor: Research Institute of Ophthalmology, Egypt
Sponsor class: OTHER
First posted: 2021-10-06
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double blinded randomized syudy
Primary purpose: PREVENTION

Brief summary: comparing two local anaesthetic agents, Bupivacaine 0.5% versus Oxybuprocaine used topically to provide surface anaesthesia before IVI procedures.

Detailed description: In preparation zone, we will cannulate the patients, connect them to the pulse oximetry and we will start providing appropriate surface anaesthesia for an adequate period of time before the patient administration of the injection, by applying the anaesthetic agents, 3 times with 5 minutes interval, for 15 minutes and then waitng the injection

All patients are informed that they are going to receive topical anaesthetic agent before the IVI.

pain is monitored during the injection by using the 11 points verbal numerical pain scaling as zero is for no pain and 10 is for severe unbearable pain.

Eligibility criteria: Inclusion Criteria:

* All patients between 30 to 70 years

Exclusion Criteria:

* uncooperative patients

Primary outcomes:
measure: verbal pain numerical scaling
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Research Institute of Ophthamology
state: Haram
Study officials:
References: