louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06146244: Comparison of ISQ in Implants Placed in Antral Area on Native Bone vs Regenerated Bone
Official title: Comparison Between Value of Resonance Frequency Analysis (ISQ) in Implants Placed in Antral Area on Native Bone vs Value Obtained in Implants Placed in Antral Area on Regenerated Bone and Its Evolution After 3 Months
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Implant Site Reaction
Keywords: Implant placement
native bone
regenerated bone
resonance frequency analysis
ISQ value
Ostell
Lead sponsor: European University of Madrid
Sponsor class: OTHER
First posted: 2023-11-24
Enrollment: 132
Sex: ALL
Minimum age (years): 23
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study group is made up of adult patients from the UEM Dental University Clinic, from September 2017 to September 2018, who attended the Master's Degree in Advanced Oral Implantology and who were informed of the study and signed the informed consent.

Brief summary: Compare ISQ values of implants placed in antral area in native bone vs regenerated bone with a follow-up at 3 months to compare values changes.

Detailed description: The stability of dental implants is influenced by the type of bone in which the implant is placed. Native bone tends to provide better initial stability due to its density and quality, while regenerated bone, it is logical to think that it may present less stability due to the quality of the generated bone and the presence of defects in the treated area.

In this study it has been observed that after 3 months more stability is observed in the antral area, measured in ISQ resonance frequency in implants on regenerated bone, which surprises us and this result is explained in detail in said study.

Eligibility criteria: Inclusion Criteria:

* Adult patients
* Total superior edentulism or antral zone edentulism
* Accepted study and signed inform consent

Exclusion Criteria:

* Patients under 23 years old
* Non accepted study or signed inform consent

Primary outcomes:
measure: Resonance frequency analysis (ISQ) measurements
timeFrame: 3 months
Secondary outcomes:
measure: Insertion torque measurements
timeFrame: During implant placement
measure: Changes in the marginal bone
timeFrame: 3 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Dental Clinic of the UEM
Study officials:
affiliation: European University of Madrid
name: Sergio Trapote Mateo, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00474344: Genetic Linkage Study of Idiopathic Talipes Equinovarus (ITEV) (Clubfoot)
Official title: Genetic Linkage Study of Idiopathic Talipes Equinovarus (ITEV) (Clubfoot)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Clubfoot
Keywords: Genetics
Clubfoot
DNA
Idiopathic Talipes Equinovarus also known as Clubfoot
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Shriners Hospitals for Children
First posted: 2007-05-16
Enrollment: 370
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: One family member, usually child, must have clubfoot.

Brief summary: The goal of this study is to identify and characterize the genetic loci causing idiopathic talipes equinovarus (clubfoot).

The hypothesis is that a few genes account for a substantial fraction of ITEV and that these genes can be identified in defined populations. Towards this goal, in preliminary studies, Dr. Hecht's group has identified two genes, NAT2 and CASP10, which demonstrate evidence for linkage and association to ITEV.

Detailed description: Blood Collection: For this study, the investigators need to obtain blood samples from members of families in which clubfoot has occurred; more specifically, blood samples from the affected child and both parents. DNA will be extracted from blood samples. The DNA will then be tested to look for genetic factors that cause clubfoot.

Study Questionnaires: As well as the blood samples, the investigators have a short questionnaire for the mother of the child with clubfoot to complete.

Eligibility criteria: Inclusion Criteria:

* One family member, usually child, must have clubfoot

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas
state: Texas
city: Vancouver
country: Canada
facility: BC Children's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Christine Alvarez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00746044: Measurement of MRP2 Function Using Urinary Coproporphyrins
Official title: Evaluation of the Ratio of Urinary Coproporphyrins I and III as a Potential Biomarker of MRP2 Function in Man
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Subjects
Keywords: Healthy
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2008-09-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 40 healthy subjects \> 18 y 20 male, 20 female

Brief summary: Human Multidrug Related Protein 2 (MRP2) excretes several drugs and could therefore modulate their elimination. Individual's MRP2 activity is under genetic control. Thus it would be very useful to get an easily measurable biomarker reflecting individual's MRP2 activity. We aimed to investigate the ratio of urinary coproporphyrins I and III (UCP(I/I+III), known to be increased in patients with mutations in MRP2/ABCC2 gene.


Eligibility criteria: Inclusion Criteria:

* Healthy
* \> 18 y
* Affiliated to an health insurance

Exclusion Criteria:

* Patient not able to understand or to comply to the protocol

Primary outcomes:
measure: Urinary coproporphyrins (I/I+III)ratio
timeFrame: End of three 24-hours periods
Secondary outcomes:
measure: ABCC2 polymorphisms
timeFrame: At the time of entering in the study
Other outcomes:
Locations:
city: Tours
country: France
facility: CHRU de TOURS
Study officials:
affiliation: CHRU TOURS
name: Chantal LE GUELLEC
role: STUDY_DIRECTOR
References:
Clinical trial NCT00892944: An Open Label Positron Emission Tomography (PET) Study to Determine Central mGluR5 Receptor Occupancy of AZD2516
Official title: An Open Label Positron Emission Tomography (PET) Study With [11C]AZ12713580 to Determine Central mGluR5 Receptor Occupancy of AZD2516 After Oral Administration to Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Positron Emission Tomography
Phase 1
Healthy volunteers
AZD2516
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-05-05
Enrollment: 6
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine if AZD2516 binds to mGluR5 receptors in the brain. This will then help to make accurate predictions of efficacy and dosing in the future development programme.


Eligibility criteria: Inclusion Criteria:

* Normal MRI scan
* Healthy male or non-fertile females
* Body Mass Index (BMI) of ≥19 to ≤28 kg/m2 and weight of ≥50 to ≤100 kg

Exclusion Criteria:

* History of disease or condition that may interfere with the objectives of the study
* History of previous or ongoing psychiatric disease/condition
* Concomitant medication

Primary outcomes:
measure: Positron emission tomography to determine if AZD2516 can displace the radioligand [11C]AZ12713580 and describe relationship between AZD2516 exposure and mGluR5 receptor occupancy
timeFrame: 1 Month: Baseline and 3 PET examinations
Secondary outcomes:
measure: Safety and tolerability of AZD2516 by adverse events, vitals signs, ECG, body temperature and laboratory variables
timeFrame: Assessed at each visit from baseline to follow-up visit
measure: To investigate the Pharmacokinetics of AZD2516
timeFrame: 1 Month: 3 doses AZD2516 and 16 planned PK samples after each dose
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca Clinical Pharmacology Unit, Stockholm, Sweden
name: Ingemar Bylesjo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca R&D, Södertälje, Sweden
name: Michael O'Malley
role: STUDY_DIRECTOR
References:
Clinical trial NCT03755544: Salmeterol/Fluticasone Easyhaler in the Treatment of Asthma and COPD
Official title: Salmeterol/Fluticasone Easyhaler in the Treatment of Asthma and COPD; a Non-interventional Switch Study to Evaluate the Impact on Clinical Effects, Patient's Satisfaction, Preference and Use of Easyhaler
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Chronic Obstructive Pulmonary Disease
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2018-11-28
Enrollment: 231
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be enrolled by physicians from outpatient clinics

Brief summary: A non-interventional study to assess the clinical effectiveness of Salmeterol/fluticasone Easyhaler to achieve and maintain asthma or COPD control.

Detailed description: A prospective, open-label, non-interventional, multicentre study in adult patients with asthma or COPD who are treated with Salmeterol/fluticasone Easyhaler. During the study the Salmeterol/fluticasone Easyhaler will be used according to the Summary of Product Characteristics. Clinical effectiveness of the treatment will be evaluated with change in asthma or COPD symptoms during 12 weeks treatment.

Eligibility criteria: Main Inclusion Criteria:

1. Male or female patients with asthma or COPD who have been using salmeterol/fluticasone propionate combination treatment for at least 3 months before the study
2. Age ≥18 years.
3. Written informed consent obtained.

Main Exclusion Criteria:

1. Pregnant or lactating female patients.
2. Participation in other clinical studies during the study.
3. Known hypersensitivity (allergy) to salmeterol, fluticasone propionate or the excipient lactose
4. Any significant medical disease or condition or other factor that might interfere with study assessments or study participation.

Primary outcomes:
measure: Asthma Control Test (ACT)
timeFrame: 12 weeks
measure: COPD Assessment Test (CAT)
timeFrame: 12 weeks
Secondary outcomes:
measure: Asthma symptom control assessment
timeFrame: 12 weeks
measure: Forced expiratory volume in one second (FEV1)
timeFrame: 12 weeks
measure: Feeling of Satisfaction with Inhaler questionnaire (FSI-10)
timeFrame: 12 weeks
measure: A questionnaire to assess Physician's/nurse's perception of Salmeterol/fluticasone Easyhaler overall use
timeFrame: 12 weeks
measure: Mini-AQLQ questionnaire
timeFrame: 12 weeks
measure: Health care utilisation questionnaire
timeFrame: 24 weeks
measure: Modified Medical Research Council (mMRC) dyspnea questionnaire
timeFrame: 12 weeks
measure: Symptom burden and exacerbation risk assessment (ABCD classification)
timeFrame: 12 weeks
measure: Forced vital capacity (FVC)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Lungenpraxis
Study officials:
affiliation: Orion Corporation, Orion Pharma
name: Orion Pharma Clinical Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02257944: Assessing and Reducing Risk of Violent Re-Injury Among Victims of Urban Violence
Official title: Assessing and Reducing Risk of Violent Re-Injury Among Victims of Urban Violence: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Violence
Lead sponsor: Conrad, Erich J., M.D.
Sponsor class: OTHER
First posted: 2014-10-07
Enrollment: 100
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: The purpose of the study is to develop a program to help people to lower their chances of being violently injured again.


Eligibility criteria: Inclusion Criteria:

* age between 18-65 years
* intentionally injured in community violence.
* admitted to a Level 1 trauma center
* able to provide voluntary informed consent

Exclusion Criteria:

* under the age of 18 or over the age of 55.
* not fluent in the English language
* patients with suspected mental retardation or active psychosis as determined by brief clinical screen.
* patients currently in legal detention status

Primary outcomes:
measure: Risk Factors for Violence
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: LSUHSC Trauma Psychiatry Reserach Unit
name: Erich J Conrad, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00157144: Australia and New Zealand Adult Extracorporeal Membrane Oxygenation (ECMO) Audit 2005
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Shock, Cardiogenic
Keywords: Lung Transplantation
Heart Transplantation
Lead sponsor: Bayside Health
Sponsor class: OTHER_GOV
First posted: 2005-09-12
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE

Brief summary: Extracorporeal membrane oxygenation (ECMO) is a means of artificially performing the function of the human lung and/or heart outside the body. Its use is escalating in a wide range of clinical settings in the adult population without evidence or guidelines to support this practice.

This study involves a nationwide questionnaire which has two components. The initial pilot survey will attempt to identify all institutions currently practicing ECMO or those intending to do so in the future, and are willing to participate in prospective data collection. The second phase will involve a monthly survey of these centres regarding the extent of ECMO use, practice details implemented, and outcome data.

It is hoped that the collection of this information will later assist in the development of guidelines for this expensive and presently unsubstantiated practice, together with the construction of appropriate training programs for staff.


Eligibility criteria: Inclusion Criteria:

* Patients receiving ECMO in Australia and New Zealand

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
Study officials:
affiliation: National Health and Medical Research Council, Australia
name: Vincent A Pellegrino, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hastings SL, Pellegrino VA, Preovolos A, Salamonsen RF. Survey of adult extracorporeal membrane oxygenation (ECMO) practice and attitudes among Australian and New Zealand intensivists. Crit Care Resusc. 2008 Mar;10(1):46.
Clinical trial NCT05333744: The Combination of Prednisone and Recombinant Human Thrombopoietin for Treatment of Immune Thrombocytopenia in Pregnancy
Official title: The Combination of Prednisone and Recombinant Human Thrombopoietin vs Prednisone Monotherapy for Treatment in Immune Thrombocytopenia in Pregnancy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Immune Thrombocytopenia
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2022-04-19
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized, open-label study to compare the efficacy and safety of prednisone plus recombinant human thrombopoietin (rhTPO) compared to prednisone monotherapy for the treatment of immune thrombocytopenia in pregnancy

Detailed description: The investigators are undertaking a parallel group, randomized controlled trial of adults with ITP in pregnancy in China. Patients were randomized to prednisone plus rhTPO and prednisone monotherapy group. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.

Eligibility criteria: Inclusion Criteria:

1. Age 18-49;
2. Gestational weeks ≥20 weeks;
3. Platelet count \<30×10\^9/L, accompanied with or without bleeding symptoms;
4. Confirmed diagnosed, treatment-naive ITP in pregnancy;
5. Willing and able to sign written informed consent.

Exclusion Criteria:

1. Secondary ITP such as drug-related thrombocytopenia;
2. Thrombocytopenia caused by viral infection (HIV, hepatitis B or hepatitis C); Other autoimmune diseases (including positive anti-nuclear antibodies, positive anti-cardiolipin antibodies, positive lupus anticoagulant factors, and positive Coombs) with severe heart, kidney, liver or respiratory dysfunction;
3. Severe immunodeficiency;
4. Myelodysplastic or myeloid fibrosis;
5. History of malignancy.

Primary outcomes:
measure: Response
timeFrame: day 14
measure: Platelet counts at delivery
timeFrame: At delivery
Secondary outcomes:
measure: Number of patients with bleeding
timeFrame: During treatment（up to 6 weeks after delivery）
measure: Number of patients with adverse events
timeFrame: During treatment（up to 6 weeks after delivery）
measure: Platelet counts of newborns
timeFrame: at delivery
measure: Number of newborns with adverse events
timeFrame: During treatment（up to 6 weeks after delivery）
measure: Loss of response
timeFrame: During treatment（up to 6 weeks after delivery）
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Insititute of Hematology, Peking University People's Hospital
Study officials:
affiliation: Peking University People's Hospital, Peking University Insititute of Hematology
name: Xiao-hui Zhang, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01246544: Helsinki Declaration on Patient Safety
Official title: Helsinki Declaration on Patient Safety
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patient Safety
Keywords: Patient Safety
The Helsinki Declaration on Patient Safety in Anaesthesiology
Helsinki Declaration on Patient Safety
European Board of Anaesthesiology (EBA)
European Society of Anaesthesiology (ESA)
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2010-11-23
Enrollment: 28
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Members of the innovation alliance Berlin-Brandenburg (INABBRA)

Brief summary: In cooperation with INABBRA (Innovation Alliance Berlin-Brandenburg, Germany) the investigators would like to ask medical colleagues in the region to participate in an anonymous German online survey on patient safety.

The investigators want to investigate the implementation and establishment of measures on patient safety, that anaesthesiologists utilize to fulfill their obligations.

Detailed description: The Declaration builds on earlier statements about safety and quality of care. It represents a shared European opinion of what currently is both worth doing and practical to improve patient safety in anaesthesiology in 2010. The Declaration recommends practical steps that all anaesthesiologists who are not already using them should include in their own practice. These are relatively straightforward and where they are currently being used have a track record of improving patient safety. All European anaesthesiology institutions are expected to support the World Health Organization(WHO) 'Safe Surgery Saves Lives' initiative including the "Safe Surgery Checklist". The Declaration was endorsed by European Board of Anaesthesiology (EBA) and the European Society of Anaesthesiology (ESA). It was officially launched at the Euroanaesthesia congress in Helsinki in June 2010 and was subsequently signed by several representatives of European anaesthesiology and different additional stakeholders (WHO, World Federation of Societies of Anaesthesiologists (WFSA), European Patients Federation (EPF)).

In cooperation with INABBRA (Innovation Alliance Berlin-Brandenburg, Germany) the investigators would like to ask medical colleagues in the region to participate in an anonymous German online survey on patient safety.

The investigators want to investigate the implementation and establishment of measures on patient safety, that anaesthesiologists utilize to fulfill their obligations under the perspective of the Declaration.

Eligibility criteria: Inclusion Criteria:

Members of the innovation alliance Berlin-Brandenburg (INABBRA)

Primary outcomes:
measure: Actual level on patient safety in Berlin-Brandenburg
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum/Campus Charité Mitte, Charité Universitätsmedizin
Study officials:
References:
Clinical trial NCT03385044: Comparison of Endotracheal Intracuff Pressure Between Two Cuff Sealing Methods
Official title: Comparison of Endotracheal Intracuff Pressure Between Two Cuff Sealing Methods
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endotracheal Tube
Keywords: Endotracheal tube
Intracuff pressure
Minimal occlusive volume technique
Spirometer
Endotracheal sealing
Lead sponsor: DongGuk University
Sponsor class: OTHER
First posted: 2017-12-28
Enrollment: 35
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Two methods of cuff sealing will be applied in a random sequence to each patient.
Primary purpose: TREATMENT

Brief summary: The endotracheal intracuff pressure is to be maintained at a low level to prevent trachea and nerve damages, and yet be high enough to secure air sealing. The objective of the study is to compare minimal occlusive volume technique (MOVT) and expired volume/inspired volume ratio (VE/VI ratio) from a spirometer method of endotracheal tube (ETT) cuff inflation with respect to the cuff pressure required to seal the airway during a laparoscopic surgery under general anesthesia. A study design is a randomized crossover trial in 35 patients. The primary outcome is the intracuff pressure of an endotracheal tube. The study consists of two cuff sealing methods separated by a period of 10 minutes.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical status I, II
* Body mass index \< 30 kg/m2
* Elective laparoscopic gynecologic surgery under general anesthesia in the Trendelenburg position

Exclusion Criteria:

* History of airway-related or pulmonary diseases/abnormalities
* When difficult intubation is anticipated
* History of general anesthesia within the past 3 months
* Pregnancy
* History of smoking

Primary outcomes:
measure: Intracuff Pressure
timeFrame: From the start of cuff inflation to the airway sealing, an average of 2 minutes
Secondary outcomes:
measure: Intracuff air volume
timeFrame: From the start of cuff inflation to the airway sealing, an average of 2 minutes
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: Dept. of anesthesiology and pain medicine, Dongguk University Ilsan Hospital
state: Gyeonggido
Study officials:
affiliation: DongGuk University
name: Junyong In, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: