louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04006678: Evaluation of Accuracy of Computer Guided Versus Conventional Segmental Sandwich Osteotomy With Immediate Implant Placement in Vertically Deficient Anterior Maxilla
Official title: Evaluation of Accuracy of Computer Guided Versus Conventional Segmental Sandwich Osteotomy With Immediate Implant Placement in Vertically Deficient Anterior Maxilla
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sandwich Osteotomy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In conventional segmental sandwich osteotomy technique the moving the transport segment inferiorly to increase the vertical height causes the segment to move bucco-palatally, increasing the horizontal defect. So using the computer guided in segmental sandwich osteotomy and fixation the transport segment hopefully will reduce the bucco-palatal tipping.


Eligibility criteria: Inclusion Criteria:

* Patients with vertically deficient anterior maxillary ridge a minimum 10 mm. height of alveolar bone.
* Patients with medical history that did not hinder implant placement (uncontrolled diabetes) and adequate proper oral hygiene.
* Patients of adequate alveolar bone width.
* Both genders males and females will be included.

Exclusion Criteria:

* General contraindications to implant surgery.
* Subjected to irradiation in the head and neck area less than 1 year before implantation.
* Untreated periodontitis.
* Poor oral hygiene and motivation.
* Uncontrolled diabetes.
* Pregnant or nursing.
* Substance abuse.
* Psychiatric problems or unrealistic expectations.
* Severe bruxism or clenching.
* Immunosuppressed or immunocompromised.
* Treated or under treatment with intravenous amino-bisphosphonates.
* Lack of opposite occluding dentition/prosthesis in the area intended for implant placement.
* Active infection or severe inflammation in the area intended for implant placement.
* Need of bone augmentation procedures at implant placement.
* Unable to open mouth sufficiently to accommodate the surgical tooling.
* Patients participating in other studies, if the present protocol could not be properly followed.
* Referred only for implant placement or unable to attend a 5-year follow-up.
* Requiring only single implant-supported crowns.

Primary outcomes:
measure: bucco - palatal tipping
timeFrame: 6 months
Secondary outcomes:
measure: marginal bone loss
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: shareif nazzal
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01726478: Uterotonic Efficacy of Oxytocin 2.5 Versus 10 Units During Caesarean Section at Mulago Hospital
Official title: Uterotonic Efficacy of Oxytocin 2.5 Versus 10 Units During Caesarean Section at Mulago Hospital; Adouble Blinded Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adverse Effect of Oxytocic Drugs
Uterine Hemorrhage
Inappropriate Dose of Drug Administered
Keywords: Oxytocin
Uterine tone
Mulago Hospital
Dose
Side effects
Lead sponsor: Makerere University
Sponsor class: OTHER
First posted: 2012-11-15
Enrollment: 386
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study was to determine whether 2.5 international units of oxytocin gives adequate uterine tone and is safe as compared to 10 international units of oxytocin following caesarean section delivery at Mulago hospital.


Eligibility criteria: Inclusion Criteria:

* ASA I (Healthy patient with no systemic disease) or II ( mild to moderate systemic disease)
* Age between 18 to 40 years
* Singleton pregnancies

Exclusion Criteria:

* • Allergy to oxytocin

  * Ruptured uterus
  * Significant obstetric disease (including Pregnancy induced Hypertension, Eclampsia,)
  * Known risk factors for postpartum haemorrhage or uterine atony
  * Inherited or acquired coagulation disorder
  * History of post partum haemorrhage

Primary outcomes:
measure: Uterine tone adequacy
timeFrame: 2 minutes
Secondary outcomes:
measure: Intraoperative blood loss
timeFrame: 24 hours
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Mulago Hospital Labour Suite Operating Theatres
state: East Africa
Study officials:
affiliation: Makerere University College of Health Sciences Department of Anaesthesia
name: Andrew Kintu, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05577078: TriBEL Registry: National Belgian Registry of Percutaneous Tricuspid Valve Repair Using a Transcatheter Edge-to-edge Repair Technique
Official title: TriBEL Registry: National Belgian Registry of Percutaneous Tricuspid Valve Repair Using a Transcatheter Edge-to-edge Repair Technique
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Tricuspid Valve Regurgitation
Lead sponsor: AZ Sint-Jan AV
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with tricuspid valve regurgitation eligible for transcatheter edge-to-edge repair

Brief summary: In this study, patients who have undergone or will undergo a transcatheter edge-to-edge repair (TEER) for tricuspid valve regurgitation (TR) will be followed up for 5 years. The goal of this prospective and retrospective, observational, non-randomized, multicenter registry is to confirm that TEER is a feasible, safe and effective treatment option for TR and to evaluate the long-term efficacy and safety of TEER.

The main endpoints are:

* Change in tricuspid regurgitation grade: number of patients with a reduction in tricuspid regurgitation score by at least one grade
* Composite of major adverse event: number of patients with composite of major adverse event (cardiovascular mortality, acute kidney injury, myocardial infarction, stroke or TIA, coronary revascularization, new onset AF or ventricular arrhythmia)


Eligibility criteria: Inclusion Criteria:

* At least 18 years old
* Eligible for TEER procedure
* Informed consent signed

Exclusion Criteria:

* Unwilling to provide informed consent

Primary outcomes:
measure: Number of patients with a reduction in tricuspid regurgitation score by at least one grade
timeFrame: 30 days
measure: Composite of major adverse event
timeFrame: 1 year
Secondary outcomes:
measure: Number of patients with a reduction in tricuspid regurgitation score by at least one grade at 6 months post-procedure
timeFrame: 6 months
measure: Number of patients with a reduction in tricuspid regurgitation score by at least one grade 1 year post-procedure
timeFrame: 1 year
measure: Number of patients with a reduction in tricuspid regurgitation score by at least one grade 2 years post-procedure
timeFrame: 2 years
measure: Number of patients with a reduction in tricuspid regurgitation score by at least one grade 3 years post-procedure
timeFrame: 3 years
measure: Number of patients with a reduction in tricuspid regurgitation score by at least one grade 4 years post-procedure
timeFrame: 4 years
measure: Number of patients with a reduction in tricuspid regurgitation score by at least one grade 5 years post-procedure
timeFrame: 5 years
measure: Composite of major adverse event at discharge
timeFrame: 5 days
measure: Composite of major adverse event at 5 years post-procedure
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00622778: Immunemodulation in Patients With Minor Head Injury
Official title: Diagnostic Algorithm in Minor Head Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head Trauma
Keywords: intracranial bleeding
computed tomography scan
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2008-02-25
Enrollment: 130
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from daily practice

Brief summary: The purpose of this study is to try to prove the worth of the two (2) Serum Proteins S-100 Beta and NSE in combination with a diagnostic algorithm to help to establish diagnosis in patients with minor head injury.


Eligibility criteria: Inclusion Criteria:

* minor head injury

Exclusion Criteria:

* severe head injury

Primary outcomes:
measure: Intracranial Haematoma
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Head of Department
name: Vilmos Vecsei, M.D. Professor
role: STUDY_CHAIR
References:
citation: Pelinka LE, Toegel E, Mauritz W, Redl H. Serum S 100 B: a marker of brain damage in traumatic brain injury with and without multiple trauma. Shock. 2003 Mar;19(3):195-200. doi: 10.1097/00024382-200303000-00001.
citation: Pelinka LE, Bahrami S, Szalay L, Umar F, Redl H. Hemorrhagic shock induces an S 100 B increase associated with shock severity. Shock. 2003 May;19(5):422-6. doi: 10.1097/01.shk.0000055345.58165.52.
citation: Pelinka LE, Kroepfl A, Leixnering M, Buchinger W, Raabe A, Redl H. GFAP versus S100B in serum after traumatic brain injury: relationship to brain damage and outcome. J Neurotrauma. 2004 Nov;21(11):1553-61. doi: 10.1089/neu.2004.21.1553.
citation: Wolf H, Frantal S, Pajenda GS, Salameh O, Widhalm H, Hajdu S, Sarahrudi K. Predictive value of neuromarkers supported by a set of clinical criteria in patients with mild traumatic brain injury: S100B protein and neuron-specific enolase on trial: clinical article. J Neurosurg. 2013 Jun;118(6):1298-303. doi: 10.3171/2013.1.JNS121181. Epub 2013 Mar 1.
Clinical trial NCT02151578: Home Management of Malaria and Pneumonia
Official title: Home and Community Management of Fevers/Malaria and Pneumonia in Children Under-five: a Cluster Randomised Controlled Trial of an Integrated Approach in a Rural District of Burkina Faso
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malaria
Pneumonia
Keywords: Impact of home management of malaria and pneumonia on child mortality
home management of malaria and pneumonia
Lead sponsor: World Health Organization
Sponsor class: OTHER
First posted: 2014-05-30
Enrollment: 11500
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A well-implemented community-based program of early and appropriate treatment of fevers/malaria episodes and pneumonia,will improve child survival as measured by a reduction of the less than five mortality rate.

Detailed description: An integrated approach of home and community management of malaria and pneumonia may increase the proportion of children receiving prompt treatment; improve child survival as measured by a reduction of the under five mortality rate. To test this hypothesis, a cluster randomised controlled trial will be performed, involving children less than 5 years of age, in Burkina Faso using a community-based supplying community health workers (CHWs), a core group of mothers (KOLs) with Coartem and cotrimoxazole specially packed in age-specific blisters containing a full course of treatment. The study will be carried out in 111 clusters of a rural district in Burkina Faso where malaria and pneumonia are two major mortality causes in under five mortality.

Eligibility criteria: Inclusion Criteria:

* living in one of the study cluster (villages)
* no story of allergy to any of the study drugs
* history of fever or body temperature \>= 38.5°C

Exclusion Criteria:

* signs of severity/complications like impaired consciousness, convulsions, fast breathing etc

Primary outcomes:
measure: Number of death in children aged 6 to 59 months
timeFrame: 12 months
Secondary outcomes:
measure: - specific mortality preceded by acute febrile illness of children aged 6 to 59 months - severe malaria cases at community level
timeFrame: 12 months
Other outcomes:
measure: Adverse events at community level consecutive to the administration of the cotrimoxazole and arthemeter/lumefantrine
timeFrame: 7 days after the administration of the drug
Locations:
city: Ouagadougou
country: Burkina Faso
facility: Groupe de Recherche Action en Sante (GRAS sarl)
state: Kadiogo
Study officials:
affiliation: Groupe de Recherche Action en santé (GRAS), 06 BP 10248 Ouagadougou 06, Burkina Faso
name: Sodiomon Bienvenu SIRIMA, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oliphant NP, Manda S, Daniels K, Odendaal WA, Besada D, Kinney M, White Johansson E, Doherty T. Integrated community case management of childhood illness in low- and middle-income countries. Cochrane Database Syst Rev. 2021 Feb 10;2(2):CD012882. doi: 10.1002/14651858.CD012882.pub2.
Clinical trial NCT06004778: The Effect of Motivational Support Program Applied to Adolescents on Sleep Quality and Academic Achievement
Official title: Lecturer (Academician at University)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: High School 11th Grade Students
Absence of Any Language, Hearing, Mental or Psychological Disability
Turkish Speaking and Understanding
Having a PUKI Index Above 5ı
Absence of Any Chronic Disease
Obtaining Permission From Parents and Students
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2023-08-22
Enrollment: 84
Sex: ALL
Minimum age (years): 16
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: It was planned as a randomized controlled experimental study with a single-blind technique, pretest-posttest control group and repetitive measurements, in order to determine the effect of motivational support program applied to adolescents and education on sleep quality.


Eligibility criteria: Inclusion Criteria:

* No language disorders
* No hearing disorders
* No mental disorders
* Bad sleep quality
* No chronic disease

Exclusion Criteria:

* Sleeping pill
* Psychiatric illness

Primary outcomes:
measure: Sleep quality Score
timeFrame: up to 2 months (1 OCTOBER 2023-30 NOVEMBER 2023)
Secondary outcomes:
measure: Academic Achievement Score
timeFrame: up to 2 months (1 OCTOBER 2023-30 NOVEMBER 2023)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Demet Sökün Ayaz
Study officials:
References:
Clinical trial NCT05749978: Effects of Postural Adjustment on Hemodynamics in Patients Undergoing Prone Spine Surgery Under General Anesthesia
Official title: Effects of Postural Adjustment on Hemodynamics in Patients Undergoing Prone Spine Surgery Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asana Adjustment
Keywords: Trendelenburg position
Prone Position
Hemodynamics
Intra-abdominal pressure
Cardiac output
Lead sponsor: Yangzhou University
Sponsor class: OTHER
First posted: 2023-03-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The prone position is a special position often used for spinal surgery. As a special position of general anesthesia, after induction of general anesthesia, severe hemodynamic fluctuations often occur when the supine position is changed to the prone position, which seriously affects the patient's circulatory and respiratory functions.


Eligibility criteria: Inclusion Criteria:

1. Prone spine surgery after general anesthesia is planned.
2. Age 18\~85 years old.
3. ASA grade I or II.
4. BMI18.3-30kg/m2

Exclusion Criteria:

1. Unstable angina or myocardial infarction, coronary heart disease, congestive heart failure, structural heart disease, arrhythmia within 6 months;
2. Increased intracranial pressure and central nervous system injury or disease;
3. Severe hypertension
4. Patients with other diseases affecting their own circulatory system.
5. Have or have a history of severe mental disorders;
6. Bleeding volume \>600ml or intraoperative blood transfusion treatment.
7. Severe liver and kidney insufficiency

Primary outcomes:
measure: Change in Blood pressure
timeFrame: Preoperatively,5 minute after anesthesia induction,Immediately before the prone position, Immediately after the prone position,1 minute after prone position, 3 minute after prone position,10 minute after prone position,Half an hour after prone position
measure: Changes in the level of Cardiac output
timeFrame: Preoperatively,5 minute after anesthesia induction,Immediately before the prone position, Immediately after the prone position,1 minute after prone position, 3 minute after prone position,10 minute after prone position,Half an hour after prone position
Secondary outcomes:
measure: Intra-abdominal pressure level
timeFrame: Preoperatively,5 minute after anesthesia induction,Immediately before the prone position, Immediately after the prone position,1 minute after prone position, 3 minute after prone position,10 minute after prone position,Half an hour after prone position
measure: Vasoactive drugs
timeFrame: Intraoperatively
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: the Affiliated Hospital of Yangzhou University, Yangzhou University
state: Jiangsu
Study officials:
References:
Clinical trial NCT01476878: Frameless Stereotactic Radiosurgery for Brain Metastases
Official title: Frameless Stereotactic Radiosurgery for Brain Metastases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Brain Metastases
Keywords: Radiosurgery
Frameless radiosurgery
Accuracy
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
Collaborators: name: Tom Baker Cancer Centre
First posted: 2011-11-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators plan to study high dose, single treatment radiation, using a plastic mask instead of a head frame that pins into a patient's skull. The investigators need to (1) quantify set-up accuracy and patient motion during radiation treatment and (2) ensure that without the head frame the tumour control rate and risk of complications are similar to our previous experience using the head frame.


Eligibility criteria: Inclusion Criteria:

* Patients with brain metastases from a biopsy-proven primary extra-cranial tumor site, excluding lymphoma, germ cell, and small cell lung carcinoma histologies.
* One to four metastases, and all lesions \< 3.5 cm in maximal diameter. Extracranial metastases is of minimal volume or stable with treatment. - Karnofsky performance status ≥ 70

Exclusion Criteria:

* None of the lesions is abutting or within critical neurological structures: \*brainstem

  * optic chiasm
  * eye, and optic nerve.
* The clearance between metastatic lesions and all critical structures must be at least 2 mm.
* Patients must not have leptomeningeal disease.
* Contraindications to imaging or radiation (e.g. pregnancy, elevated serum creatinine, allergy to contrast agents, severe claustrophobia, metal particles in the eye).

Primary outcomes:
measure: Quantification of patient movement occurring during treatment.
timeFrame: overall
Secondary outcomes:
measure: Local tumour control
timeFrame: overall
measure: risk of complication (radionecrosis)
timeFrame: overall
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
Study officials:
affiliation: Tom Baker Cancer Centre
name: Jon-Paul Voroney, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02558478: Identification of New Genes Implicated in Rare Neurosensory Diseases by Whole Exome Sequencing
Official title: Identification of New Genes Implicated in Rare Neurosensory Diseases by Whole Exome Sequencing
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neurosensory Diseases
Retinopathy
Hearing Loss
Keywords: Whole exome sequencing
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2015-09-24
Enrollment: 39
Sex: ALL
Minimum age (years): 28
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This project focuses on families with unsual phenotypes who have sensorineural disease with retinal degeneration AND/OR deafness. Our first hypothesis is that these clinical entities are associated with new genes not described to date. However, it is impossible to exclude at this stage an allelic variability (mutations in genes already known but with an unusual phenotype) or mutations in genes implicated in neurosensory diseases but not detected by prior exploration. These situations illustrate the problem of genetic complexity and difficulty of the phenotype correlations - genotype.

Brief summary: Next Generation Sequencing (NGS) strategy is a powerful tool to identify genes implicated in very rare diseases for which the previous genetic explorations remain negative to date. The aim of this project is based on groups of patients with original clinical phenotypes including neurosensory impairment without genetic cause identified to date. The investigators will study these families using whole exome sequencing to potentially identify new genes and new underlying biological pathways involved in neurosensory diseases.


Eligibility criteria: Inclusion Criteria:

* Original phenotype with neurosensory diseases
* Written, informed consent obtained

Exclusion Criteria:

* Refusal to participate at the study
* Prior inclusion in a similar study (NGS)

Primary outcomes:
measure: Whole exome sequencing data
timeFrame: 21 months
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: LABORATOIRE DE CYTOGENETIQUE, Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Sophie SCHEIDECKER, MD
role: PRINCIPAL_INVESTIGATOR
References: