louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04518215: Erector Spinae Plane Block for Paediatric Upper Abdominal Surgery
Official title: Ultrasound-Guided Erector Spinae Plane Block for Paediatric Upper Abdominal Surgery: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paediatric
Surgery
Analgesia
Anesthesia
Keywords: Erector spinae plain block
Ultrasound-guided
Paediatric
Upper abdominal surgery
Analgesia
Anesthesia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-08-19
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Upper abdominal surgeries are associated with severe postoperative pain. Thus, maintaining effective postoperative analgesia in the paediatric age group is very crucial in terms of future pain perception and chronic pain development. Erector Spinae Plane Block (ESPB) is an interfascial plane block characterized by its ease of application and low complication rates with the introduction of ultrasonography. The aim of this study is to investigate the analgesic effects of ESPB in this particular age-group.


Eligibility criteria: Inclusion Criteria:

* ASA I - II.
* Elective open upper abdominal surgeries, e.g., open cholecystectomy, splenectomy, pyeloplasty, renal cysts excision, partial or total nephrectomy.

Exclusion Criteria:

* Patient's next of kin refusal.
* Allergy to local anaesthetics.
* Infection at the site of injection.
* Coagulopathy.

Primary outcomes:
measure: Tramadol consumption.
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University Hospitals
Study officials:
affiliation: Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University
name: Atef K Salama, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University
name: Nazmy S Michael, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02608515: A Retrospective Chart Review Study of the Outcomes of 2nd Line Therapy With LEn/Dex in Greek Patients With R/R Multiple MyEloma and the Treatment PatterNs Following Progressive Disease
Official title: A Retrospective Chart Review Study of the Outcomes of Second Line Therapy With LEnalidomide/Dexamethasone in Greek Patients With Relapsed/Refractory Multiple MyEloma and the Treatment PatterNs Following Progressive Disease, "The LEGEND Study"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relapsed/Refractory Multiple Myeloma
Lead sponsor: Genesis Pharma S.A.
Sponsor class: INDUSTRY
First posted: 2015-11-18
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of approximately 220 patients with RRMM that started second-line treatment with lenalidomide/dexamethasone between 01 January 2009 to 01 March 2014 and who fulfill all study-specific eligibility criteria at the investigators' discretion will be included in this study

Brief summary: This non-interventional retrospective chart review study aims to evaluate the clinical outcomes of patients with RRMM receiving lenalidomide/dexamethasone (Len/Dex) treatment at 1st relapse and the treatment patterns following progressive disease as part of the routine clinical practice in Greece.


Eligibility criteria: Inclusion Criteria:

Subjects must fulfill ALL of the following criteria:

* Subjects of both genders, aged 18 years or older
* Subjects must have a relapsed or refractory MM diagnosis according to IMWG or EBMT criteria
* Subjects must have initiated second-line therapy with lenalidomide/dexamethasone according to the approved products' Summary of Product Characteristics (SmPC) between 01 January 2009 and 01 March 2014
* Subjects must have available medical files/records and detailed historical data on their disease course and clinical management
* Provision of signed ICF for collecting and analyzing medical data pertinent to the objectives of this study

Exclusion Criteria:

For the candidate subjects NONE of the following criteria should apply:

* Prior malignancy (within the 3 years preceding initial diagnosis of MM)
* Concurrent administration of anti-cancer regimens for malignancies other than MM between the time of initial MM diagnosis and time of second relapse
* Subject participation in an interventional study

Primary outcomes:
measure: Evaluation of the 12-month PFS rate in patients treated with Len/Dex at 1st relapse
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Patra
country: Greece
facility: Patra
Study officials:
affiliation: Medical Department of Genesis Pharma SA
name: Kiki Karvounis
role: STUDY_DIRECTOR
References:
Clinical trial NCT06794515: cGMP: Metabolism and Appetite Modulation
Official title: Metabolic Effects of cGMP: From Amino Acid Absorption Kinetics to Appetite Modulation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy
Lead sponsor: Universidade Nova de Lisboa
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Phenylketonuria is an inborn error of phenylalanine metabolism. Although the phenylalanine-restricted diet is recognized as the mainstay of therapy, little is known about the impact of protein substitutes on the metabolism of patients with phenylketonuria.

Therefore, the aim of this project is to study the impact of acute ingestion of casein glycomacropeptide supplemented with amino acids (cCGMP-AAs) alone or in combination with two different meals on amino acid absorption kinetics, glycaemic and insulinemic response, and on acute markers of appetite control.

The main findings of this project will bring new insights into the dietary management of these patients, which may lead to improvements in protein substitutes formulations.


Eligibility criteria: Inclusion Criteria:

* Men or women
* Adults (age ≥ 18 years)
* Body Mass Index (BMI) between 18.5-25.0 kg/m2
* Filling informed consent

Exclusion Criteria:

* Clinically significant illness
* Have changed frequency, duration, or intensity of physical activity in the last month
* Taking protein supplements
* Pregnant or breastfeeding
* Smoking and drug use

Primary outcomes:
measure: Changes in the iAUC (mmol/L*min) for total amino acids
timeFrame: 180 minutes
measure: Changes in the iAUC (pmol/L*min) for glucagon-like peptide-1 (GLP-1)
timeFrame: 180 minutes
measure: Changes in the iAUC (pmol/L*min) for Cholecystokinin (CCK)
timeFrame: 180 minutes
measure: Changes in the iAUC (pmol/L*min) for peptide YY (PYY)
timeFrame: 180 minutes
measure: Changes in the iAUC (pmol/L*min) for Gastric inhibitory polypeptide (GIP)
timeFrame: 180 minutes
Secondary outcomes:
measure: Changes in glucose
timeFrame: 180 minutes
measure: Changes in insulin
timeFrame: 180 minutes
measure: Changes in C-peptide
timeFrame: 180 minutes
Other outcomes:
Locations:
city: Lisboa
country: Portugal
facility: NOVA Medical School|Faculdade de Ciências Médicas, Universidade NOVA de Lisboa, Lisboa,
Study officials:
References:
Clinical trial NCT03220815: Low Speed Drilling Versus Conventional Drilling Technique on Crestal Bone Level in Maxilla.(Group A ) A Randomized Controlled Clinical Trial
Official title: Clinical Evaluation of the Effect of Low Speed Drilling Versus Conventional Drilling Technique on Crestal Bone Level in Maxilla. A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bone Resorption
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-07-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 20 patients were selected requiring implant placement and divided randomly into two groups (10 in each group)

* for the study group, starter drill is used to locate the point of insertion as planned then pilot drill is also used to the full desired working length after that all other sequential drills are used at a low speed (50-70 rpm) without irrigation .
* In the study group: implant will be inserted in the low speed osteotomy site. • In the control group: implants will be inserted in the conventional prepared osteotomy site.
* For both groups there is no surgical guide used.
* The flap will then be copiously irrigated with saline in preparation for closure.
* The flap will then be closed using interrupted 4/0 resorbable sutures.


Eligibility criteria: Inclusion Criteria:

* Patients restoring missing maxillary teeth with implant placement.
* Both sexes.
* Age: 25-45
* Mesio-distal dimensions: Not less than 6 mm
* Bone Height: Not less than 12 mm
* Bucco-lingual dimensions: Not less than 8mm
* All measures will be assessed using CBCT.

Exclusion Criteria:

* Sites needing bone grafting or augmentation.
* Heavy smokers more than 20 cigarettes per day.
* Patients with systemic disease that may affect normal healing.

Primary outcomes:
measure: crestal bone loss
timeFrame: [Time Frame: 6 month]
Secondary outcomes:
measure: patient morbidity after procedure
timeFrame: [Time Frame: 1 day]
measure: Implant stability value
timeFrame: [Time Frame: 3 month]
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00185315: Safety Follow-up Study of Inhaled Iloprost in Patients With Pulmonary Hypertension
Official title: Open-label, Uncontrolled, Long-term Surveillance Study of Iloprost Aerosol Inhalation Therapy in the Treatment of Patients With Primary or Secondary Pulmonary Hypertension. Follow-up Program for Patients Who Completed 12 Weeks in Study ME97218/300180.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension, Pulmonary
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 71
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to monitor long-term safety and tolerability of iloprost aerosol inhalation therapy in patients suffering from pulmonary hypertension.

Detailed description: This study has previously been posted by Schering AG, Germany. Schering AG has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility criteria: Inclusion Criteria:

* Completion of the 12-week treatment period of the predecessor Schering study 97218/300180
* Investigator judged iloprost aerosol therapy warranted as a suitable treatment for the respective patient
* Negative pregnancy test for females

Exclusion Criteria:

* Any condition during 12-week treatment period of the predecessor Schering study 97218/300180 that prevents participation in the follow-up safety surveillance study

Primary outcomes:
measure: Adverse events
timeFrame: Throughout the whole study
Secondary outcomes:
measure: Tolerability of treatment
timeFrame: Over a minimum of 24 months
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
city: Leuven
country: Belgium
city: Clamart Cedex
country: France
city: Grenoble Cedex 9
country: France
city: Lille
country: France
city: Reims
country: France
city: Tours Cedex
country: France
city: Bologna
country: Italy
state: BO
city: Montescano
country: Italy
state: Pavia
city: Pisa
country: Italy
state: PI
city: Amsterdam
country: Netherlands
city: Warszawa
country: Poland
city: Coimbra
country: Portugal
city: Vila Nova de Gaia
country: Portugal
city: Barcelona
country: Spain
city: Madrid
country: Spain
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03942315: Recurrence of Hereditary Hemorrhagic Telangiectasia (HHT) After Liver Transplantation
Official title: Recurrence of Hereditary Hemorrhagic Telangiectasia (HHT) After Liver Transplantation: Clinical Implications and Physiopathological Insights.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hereditary Haemorrhagic Telangiectasia
Liver Transplant
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-05-08
Enrollment: 14
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hereditary Hemorrhagic Telangiectasia (HHT) patient who underwent liver transplant

Brief summary: Liver transplantation (LT) has been proposed as a curative treatment in hereditary hemorrhagic telangiectasia (HHT) with severe hepatic involvement. The investigating team provides a long-term evaluation of graft status after LT for HHT with a focus on the risk of recurrence. The present study included all patients prospectively followed up after LT for HHT in the Lyon Liver Transplant Unit from 1993 to 2010 with a survival of more than 1 year.


Eligibility criteria: Inclusion Criteria:

* Hereditary Hemorrhagic Telangiectasia (HHT) patient who underwent liver transplant for HHT

Exclusion Criteria:

* Patient who died in the year following transplantation

Primary outcomes:
measure: Change in graft status after liver transplant for Hereditary Haemorrhagic Telangiectasia (HHT) (risk of recurrence)
timeFrame: Every 6 months after transplantation up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hospices Civils de Lyon (Hôpital Edouard Herriot )
name: Jérôme DUMORTIER, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06080815: Impact of Mandibular Overdenture Base Construction Techniques on Assessment of Occlusion
Official title: Impact of Mandibular 4-Implant Overdenture Base Construction Techniques on Assessment of Occlusion With Digital Occlusion Analysis System (Within Patient Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prosthesis Durability
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-10-12
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: According to the construction technique for the maxillary complete denture and mandibular overdentures, the patients will be classified randomly and equally into two groups.

Group I: patients receive maxillary complete denture opposed to four implant-assisted mandibular overdenture constructed with conventional method.

Group II: patients receive maxillary complete denture opposed to four implant-assisted mandibular overdenture constructed with CAD/CAM milling.
Primary purpose: TREATMENT

Brief summary: This within patient study will be conducted to compare between two different construction techniques (CAD-CAM Milled and Conventional techniques) of 4-implant-assisted complete mandibular overdenture bases regarding the digital occlusion force balance analysis using the OccluSense


Eligibility criteria: Inclusion Criteria:

* 1. Free from any systemic diseases that contraindicate dental implantation. 2. Angel's class I maxillo- mandibular relation. 3. Available inter-arch space and sufficient restorative space. 4. Nonsmokers, non-alcoholics. 5. Complaints from their conventional denture

Exclusion Criteria:

* diabetic and heavy smoker patients

Primary outcomes:
measure: digital occlusal analysis
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
Study officials:
References:
Clinical trial NCT04700215: Comparison of BiPAP and ٰIS in Reducing Post CABG Pulmonary Complications
Official title: Comparison of Effectiveness of Bilevel Positive Airway Pressure and Incentive Spirometry in Reducing Post CABG Surgery Pulmonary Complications
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Complications
Keywords: CABG
BiPAP
IS
Lead sponsor: Chaudhry Pervaiz Elahi Institute of Cardiology
Sponsor class: OTHER_GOV
First posted: 2021-01-07
Enrollment: 350
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate the effect of Bi-level Positive Airway Pressure (BiPAP) and Incentive Spirometry (IS) in post CABG patients.

Detailed description: As postoperative pulmonary complications are major concern in cardiac surgery patients and our local data is deficient for making better management guidelines. My study aims to provide a base for future research on this dimension and to decide better management plan for post cardiac surgical pulmonary complications. The hypothesis is Post extubation BiPAP is more effective than Incentive Spirometry (IS) in reducing postoperative pulmonary complications in cardiac surgical patients and the purpose of the study is to evaluate the effect of Bi-level Positive Airway Pressure (BiPAP) and Incentive Spirometry (IS) in cardiac surgical patients.

This Randomized Controlled Trial (RCT) study will be conducted at Chaudhary pervaiz elahi institute of cardiology ICU multan.

A sample size of 350 patients will be taken and effect of BiPAP and Incentive spirometry will be studied in reducing pulmonary complications post CABG surgery. Data will be analyzed through SPSS. For quantitative variables, mean and standard deviation will be calculated and for qualitative variables, frequency and percentage will be calculated. Chi square test will be used to estimate association between qualitative variables. A p value \< 0.05 will be significant.

Eligibility criteria: Inclusion Criteria:

* CABG patients
* Patient willing to study
* Patients planned for on-pump cardiac surgical procedures
* Both genders (Male \& Female)
* Age 20-60 years
* Ejection fraction 40-60%

Exclusion Criteria:

* Patients with valvular lesions
* Off-pump cardiac surgery
* Refusal to give consent for BiPAP
* Emergency surgery
* Previous cardiac surgery
* Obesity BMI\>30
* ASA status V

Primary outcomes:
measure: Post CABG pulmonary complications
timeFrame: 06 months
Secondary outcomes:
Other outcomes:
Locations:
city: Multān
country: Pakistan
facility: CPEIC
state: Punjab
Study officials:
affiliation: Chaudhry Pervaiz Elahi Institute of Cardiology
name: Muhammad Imran Khan, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04787315: Reaching Clinical Recommendations for Intensity of Post-stroke Rehabilitation
Official title: Reaching Clinical Recommendations for Intensity of Post-stroke Rehabilitation Using an Activity Circuit Implemented With a Change Agent
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Lead sponsor: Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
Sponsor class: OTHER
First posted: 2021-03-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The project aims to implement workstations for mobility training during intensive inpatient rehabilitation to increase the level of motor activity of individuals with hemiparesis due to stroke


Eligibility criteria: Inclusion Criteria:

* Receving intensive rehabilitation care for hemiparesis due to stroke in our rehabilitation facility (IRGLM)

Exclusion Criteria:

* Cognitive deficits preventing participation to rehabilitation

Primary outcomes:
measure: Actimetry
timeFrame: In the third or fourth week of rehabilitation
Secondary outcomes:
measure: Gait speed
timeFrame: Baseline, pre-intensive rehabilitation
measure: Balance capacities
timeFrame: Baseline, pre-intensive rehabilitation
measure: Gross manual dexterity
timeFrame: Baseline, pre-intensive rehabilitation
measure: Gait speed
timeFrame: End-measure, at the end of rehabilitation
measure: Balance capacities
timeFrame: End-measure, at the end of rehabilitation
measure: Gross manual dexterity
timeFrame: End-measure, at the end of rehabilitation
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: CIUSSS centre-sud-de-l'ile-de-Montréal
Study officials:
affiliation: CIUSSS Centre-Sud-de-l'ile-de-Montréal
name: Cyril Duclos, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06179615: Surface Hardness and Wear Characteristics of Prefabricated and CAD/CAM Milled Artificial Teeth
Official title: Surface Hardness and Wear Resistance of Prefabricated and CAD/CAM Milled Artificial Teeth: A Cross-over Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surface Hardness and Wear Resistance of Artificial Teeth
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-12-22
Enrollment: 10
Sex: ALL
Minimum age (years): 55
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Purpose: This study aimed to assess the 3-dimentional wear )3D) (volumetric loss) and 2-dimentional wear (2D) (vertical loss) and surface hardness of ready-made (prefabricated) and CAD/CAM milled artificial denture teeth.

material and methods: In a cross-over study design, ten completely edentulous patients were randomly chosen for this study and given two complete dentures. The first complete denture was constructed with pre-fabricated teeth. The second complete denture was constructed with CAD\\CAM milled teeth. The complete denture teeth were 3D scanned at the time of insertion (T0), after three months (T3), and after six months (T6) of denture insertion. Utilizing 3D surface superimposition techniques, the vertical (2D wear), and Volumatic (3D wear) material loss were measured. The hardness of the teeth were evaluated at the time of denture insertion (T0) then after 6 months (T6) of denture insertion by Vickers hardness test. Statistical analysis was done using SPSS software. Paired groups were compared by paired t test. Significant difference was considered if P ≤ 0.05.


Eligibility criteria: Inclusion Criteria:

* completely edentulous
* angle class I maxillomandibular relations

Exclusion Criteria:

* Angle's class II, III maxillomandibular relation
* systemic disease that affect the bone and soft tissue health

Primary outcomes:
measure: wear resistance of denture artificial teeth
timeFrame: 6 months after denture use
measure: surface hardness of the denture artificial teeth
timeFrame: 6 months after denture use
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: faculty of dentistry, Mansoura univeristy
Study officials:
References: