louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03456869: Clinical Accuracy of Patient-specific Implants in Genioplasty
Official title: The Application and Clinical Accuracy of Patient-specific Implants in Genioplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Genioplasty
Chin Microgenia
Chin Macrogenia
Keywords: patient specific implant
computer-aided surgery
clinical accuracy
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2018-03-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the accuracy and clinical validation of patient specific implants (PSI) technique for genioplasty.

Detailed description: Chin plays an important role in the lower facial harmony and balance. With the advances in computer-aided surgical simulation (CASS) technology, surgeons are now able to simulate surgical procedures in the computer to achieve the best possible surgical plan. However, CAD/CAM surgical templates do not maximize the potential of CASS technique. Patient specific implants (PSI) has rapidly developed in cranio-maxillofacial surgery in the past few years. However, few studies have introduced PSI technique in osseous genioplasty. The purpose of this study is to assess the accuracy and clinical validation of patient specific implants (PSI) technique in genioplasty for positioning and fixation of the chin segment.

Anticipated 30 patients with chin deformities are enrolled. Virtual planning is performed with the computer-aided surgical simulation method. The 3D printing titanium cutting guide and patient specific plate is involved in this PSI method. The cutting guide is designed to guide the osteotomy and screw holes drilling for the following patient specific plate. And the patient specific plate is used to simultaneously complete the reposition and fixation of the chin. The outcome is evaluated by comparing the plan with actual outcomes.

Eligibility criteria: Inclusion Criteria:

1. patients who were scheduled to undergo genioplasty;
2. patients who were scheduled to undergo CT scan as a part of their diagnosis and treatment;
3. patients who agreed to participate in this study

Exclusion Criteria:

1. craniofacial syndrome;
2. segmental osseous genioplasty;
3. previous osseous genioplasty;
4. previous mandibular trauma;
5. systemic disorders.

Primary outcomes:
measure: Positional differences of the chin between the plan and postoperative results
timeFrame: 2 weeks after the operation
measure: Orientation differences of the chin between the plan and postoperative results
timeFrame: 2 weeks after the operation
Secondary outcomes:
measure: time consuming
timeFrame: 3 days after the operation
measure: economic consuming
timeFrame: 3 days after the operation
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Study officials:
References:
Clinical trial NCT00633269: Study Assessing Metabolism, Excretion and Pharmacokinetics of a Poly (ADP-Ribose) Polymerase (PARP) Inhibitor in Patients With Solid Metastatic Tumours
Official title: Open, Non-Randomized, Single Centre Phase I Study to Assess the Metabolism, Excretion and Pharmacokinetics of a Single Oral 100 mg Dose of [14C]-AZD2281 (KU-0059436) in Patients With Advanced or Metastatic Solid Tumours Refractory to Standard Treatments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasm Metastasis
Keywords: Poly(ADP ribose) polymerases
Metastatic Solid Tumours
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: KuDOS Pharmaceuticals Limited
First posted: 2008-03-12
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Open, non-randomized, radiolabelled, single centre study designed to characterize the metabolism, excretion and pharmacokinetics of a single oral dose of 100 mg \[14C\]-radiolabelled AZD2281 (KU-0059436) in patients with advanced or metastatic solid tumours.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed advanced or metastatic tumour, refractory to standard therapies

Exclusion Criteria:

* Anti-cancer therapy including chemotherapy, radiotherapy (excluding palliative radiotherapy), endocrine therapy, immunotherapy or use of other investigational agents within 4 weeks prior to study entry.
* Patients may continue the use of LHRH agonists for cancer, bisphosphonates for bone disease and corticosteroids provided the dose is stable before and during the study.
* Females will be able to continue to take hormone replacement therapy

Primary outcomes:
measure: To characterize the metabolism, excretion and pharmacokinetics of a single oral dose of 100 mg [14C]-radiolabelled AZD2281 (KU-0059436) in patients with advanced or metastatic solid tumours, assessed by blood, urine and faecal sampling
timeFrame: Various timepoints
Secondary outcomes:
measure: To evaluate the safety and tolerability of AZD2281 (KU-0059436) by assessment of adverse events, laboratory findings and vital signs.
measure: To provide plasma and excreta samples for future studies to investigate metabolite profiles and characterize human metabolites
measure: To make a preliminary evaluation of clinical response as measured by objective tumour response rates at various timepoints.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: KuDOS Pharmaceuticals, Ltd
name: James Carmichael, BSc, MBChB, MD, FRCP
role: STUDY_DIRECTOR
affiliation: Royal Marsden Hospital, Surrey, UK
name: Johann deBono, MD, FRCP, MSc PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00525369: IL 6 Measurement Using a New Densitometric Bedside (POC) Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis, Septic Shock
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2007-09-05
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: In a equivalence analysis, we determined whether IL-6 can be assessed using a new densitometric point-of-care (POC) assay (turn-around -time: 20 minutes).IL-6 measurements were compared to test results obtained with conventional ELISA analysis

Detailed description: In an equivalence analysis, we determined whether IL-6 can be assessed using a new densitometric point-of-care (POC) assay (turn-around -time: 20 minutes) that allows IL-6 measurements at the bedside. We then compared the respective test results to those obtained with conventional ELISA analysis

Eligibility criteria: Inclusion Criteria:

* Age 18-90
* Written informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite University Medicine Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Hans-Georg Schlosser, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Charite University, Berlin, Germany
name: Joerg C Schefold, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00550069: Observational Study of Infants Born at 34 to 37 Weeks of Gestation Until the Age of 1 Year
Official title: Late Preterm Infants:Clinical Course and Outcome From Birth Through Out the First Year of Life.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Respiratory Distress
Hypoglycemia
Feeding Intolerance
Jaundice
Hypothermia
Developmental Delay
Keywords: late preterm infants
near term infants
outcome
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-10-26
Enrollment: 300
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All infants born at a gestational age of 34-37 weeks in 3 medical centers in Israel

Brief summary: Late preterm infants are at an increased risk for short and long term morbidity (during the 1st year of life, their neurodevelopmental status may also be delayed as compared to infants born at term). The term "near term infants" is probably a deceiving one.

Detailed description: The study will include all near term infants born at 3 Israeli medical centers during a one year period.

Eligibility criteria: Inclusion Criteria:

* Gestational age 34wks- 37wks
* Singleton
* Without chromosomal abnormalities or malformations

Exclusion Criteria:

* No chromosomal abnormalities
* Malformations

Primary outcomes:
measure: neurodevelopmental, health and growth status in late preterm infants vs. controls within the first year of life
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Iris Morag, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05098769: A Predictive Tool for Predicting Adverse Outcomes in Acute Pulmonary Embolism Patients Using CTPA.
Official title: A Predictive Tool for Predicting Adverse Outcomes in Acute Pulmonary Embolism Patients Using Parameters Obtained by Computed Tomographic Pulmonary Angiography.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Embolism and Thrombosis
Deterioration, Clinical
Keywords: Pulmonary Embolism and Thrombosis
Deterioration, Clinical
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2021-10-28
Enrollment: 300
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: Chinese

Brief summary: This study collected clinical, laboratory, and CT parameters of acute patients with acute pulmonary embolism from admission to predict adverse outcomes within 30 days after admission into hospital.

Detailed description: This study collected clinical, laboratory, and CT parameters of acute patients with acute pulmonary embolism from admission. The outcomes of interest were defined as the occurrence of adverse outcomes within 30 days after admission into hospital.

Eligible patients were randomized in some ratio into derivation and validation cohorts. The derivation cohort was used to develop and evaluate a multivariable logistic regression model for predicting the outcomes of interest. The discriminatory power was evaluated by comparing the nomogram to the established risk stratification systems. The consistency of the nomogram was evaluated using the validation cohort.

Eligibility criteria: Inclusion Criteria:

* age of ≥ 18 years and a PE diagnosis based on CT pulmonary angiography

Exclusion Criteria:

* pregnancy
* reception of reperfusion treatment before admission
* missing data regarding CT parameters, echocardiography, cardiac troponin I (c-Tn I), and N-terminal-pro brain natriuretic peptide (NT-pro BNP) levels.

Primary outcomes:
measure: Adverse outcomes
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Shenjing Hospital of CHINA MEDICAL UNIVERSITY
state: Liaoning
Study officials:
References:
Clinical trial NCT06601569: Predictors of Range of Motion and Balance Abnormalities in Children Diagnosed with Cerebral Palsy
Official title: Predictors of Range of Motion and Balance Abnormalities in Children Diagnosed with Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebral Palsy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children with cerebral plasy their age ranged fro 18 month t 5 yeas old

Brief summary: 1. To better understand the factors that contribute to ROM abnormalities in children diagnosed with CP.
2. To describe the distribution of primary (muscle tone and postural stability)and secondary impairments (ROM and functional muscle strength) across the gross motor spectrum measured by GMFCS scores.
3. To evaluate the effects of primary and secondary impairments on gross functional outcome in children with spastic CP.
4. To find any possible correlation between clinical variables.


Eligibility criteria: Inclusion Criteria:

* only children with clinical diagnosis of cerebral palsy , who were receiving physiotherapy services at the paediatric out-patient clinic of Faculty of Physical Therapy, Cairo University for a minimum of six months regularly.

Exclusion Criteria:

* Children were excluded if they had one or more of the following: behavioral issues, a history of persistent heart or chest disease, significant visual or auditory impairment, botulinum toxin injection at last six months prior to the study.

Primary outcomes:
measure: predictors of range of motion and balance abnormalities
timeFrame: from 1 august 2024 to 1 october 2024
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy Cairo University
Study officials:
References:
Clinical trial NCT01638169: The Contribution of Heels for Walking Quality Among Children With Muscular Dystrophy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Step Time and Length
Symmetry
Step Time and Length Variability
Heart Rate
Gait Velocity
Lead sponsor: Alyn Pediatric & Adolescent Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2012-07-11
Enrollment: 11
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children with DMD age \>6 yrs walk without heel strike

Brief summary: During the stand phase the DMD foot is too plantarflexed in addition patients adopt a higher flexion and abduction of the hip in order to advance the swinging limb. The aim of this work is to assess the immediate contribution of heels for these walking disturbance in children with muscular dystrophy disease.


Eligibility criteria: Inclusion Criteria:

* age \>6 yrs
* walk without heel strike

Exclusion Criteria:

* cannot understand simple instructions

Primary outcomes:
measure: gait parameters
timeFrame: pre and post heels adj.
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Alyn
Study officials:
References:
Clinical trial NCT03482869: Evaluation of Self-reported Walking Impairment in Predominantly Illiterate Patients
Official title: The Walking Estimated Limitation Stated by History (WELSH): A Visual Tool to Self-report Walking Impairment From a Predominantly Illiterate Diabetic Population.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes
Keywords: walking impairment
disability
diabetes mellitus
Lead sponsor: Université Polytechnique de Bobo-Dioulasso
Sponsor class: OTHER
First posted: 2018-03-29
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective cohort
Primary purpose: OTHER

Brief summary: The purpose of this study is to test the routine feasibility of an image tool adapted from the WELCH questionnaire ( Walking estimated limitation calculated by history) to estimate walking impairment (The WELSH questionnaire: Walking estimated limitation stated by history) in patients investigated for walking impairment. Secondary aims correlation with the maximal walking distance.

Detailed description: The WELSH is self completed by the patients and scored by the physician after self-completion. Patients perform a 6 minutes walking test on a 30m corridor

Eligibility criteria: Inclusion Criteria:

* •Signed consent for the data treatment as a database

Exclusion Criteria:

* Rebuttal to participate

Primary outcomes:
measure: Maximal walking distance
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Bobo Dioulasso
country: Burkina Faso
facility: CHU Souro Sanou
Study officials:
affiliation: CHU Souro Sanou
name: Nafi OUEDRAOGO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00165269: Mantle Irradiation for Hodgkin's Disease
Official title: Mantle Irradiation for Selected Hodgkin's Disease Patients With Stage IA-IIA Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hodgkin's Disease
Keywords: Hodgkin's Disease Stage IA-IIA
mantle irradiation
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: Massachusetts General Hospital
First posted: 2005-09-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study it to evaluate the effectiveness of radiation therapy limited to above the diaphragm in patients with pathological stage IA-IIA Hodgkin's disease.

Detailed description: * Eligble patients will receive a course of radiation therapy directed to above the diaphragm only.
* Patients would have bloodwork and chest x-rays performed 4 times per year for the first two years, 3 times per year for the third year, and 2 times per year for the fourth and fifth years. After five years, yearly check-ups are performed.
* In addition to the above follow-up, patients will receive, once or twice a year for the first 5 years, an abdominal-pelvic CT scan and/or gallium scan.

Eligibility criteria: Inclusion Criteria:

* Pathologically Stage IA-IIA Hodgkin's disease
* A negative staging laparotomy including splenectomy, biopsies of liver, paraortic nodal biopsies and palpitation of upper pelvic nodes
* 18 years of age or older

Exclusion Criteria:

* Patients with large mediastinal adenopathy
* Patients with LD histology
* Patients with "B" symptoms
* Positive laparotomy
* Subcarinal, hilar, or cardiac lymph node involvement

Primary outcomes:
measure: To evaluate the risks and benefits of mantle field irradiation alone in treating Hodgkin disease patients.
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Peter Mauch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06882369: TAP Block , Intrathecal Morphine Or Their Combination For Post Operative Analgesia Following TAH
Official title: Efficacy Of Transversus Abdominis Plane Block , Intrathecal Morphine Or Their Combination For Post Operative Analgesia Following Total Abdominal Hysterectomy.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Post-operative Pain Management
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2025-03-18
Enrollment: 75
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled clinical trial designed to evaluate the efficacy of transversus abdominis plane (TAP) block, intrathecal morphine, or their combination in postoperative pain relief, as assessed by time to first analgesic request, pain scores, total postoperative analgesic consumption, time of ambulation, complications and hemodynamics following total abdominal hysterectomy.


Eligibility criteria: Inclusion Criteria:

* Female patients aged 30 to 70 years.
* Elective total abdominal hysterectomy.
* ASA physical status I or II.
* Willingness to provide informed consent.

Exclusion Criteria:

* Refusal of the block.
* Allergy to study medications.
* Preexisting coagulation disorders.
* Local infection at the site of needle insertion.
* Uncontrolled respiratory or cardiac disorders.
* Impaired kidney or liver function.

Primary outcomes:
measure: Time to first analgesic request
timeFrame: 24 hours
Secondary outcomes:
measure: Total analgesic consumption
timeFrame: 24 hours
measure: Time to ambulation
timeFrame: 24 hours
measure: complications
timeFrame: 24 hours
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Faculty of Medicine, Minia University
state: El Minya
Study officials:
affiliation: Minia University, faculty of medicine
name: sohair Adeeb, assist.prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06597669: Comparison of the Treatment Outcomes of the Conventional Stainless Steel Crown Restorations and the Hall Technique in the Treatment of Carious Primary Molars
Official title: Comparison of the Treatment Outcomes of the Conventional Stainless Steel Crown Restorations and the Hall Technique in the Treatment of Carious Primary Molars
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Caries,Dental
Keywords: Dental caries
Primary molars
Stainless steel crowns
Lead sponsor: Hue University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stainless steel crowns have shown high success in restoring carious primary molars over a longer period of time than conventional restorations. This study aims to evaluate the treatment effectiveness of conventional SSCs restoration and Hall technique in treating carious primary molars


Eligibility criteria: Inclusion Criteria:

1. Agree and voluntarily participate in the research (with the patient's parent/guardian consent for participation)
2. Children have a primary molar with at least 2 carious lesions corresponding to International Caries Detection and Assessment System (ICDAS) scores 4 or at least 1 carious lesion corresponding to ICDAS scores 5 and 6.

Exclusion Criteria:

1. Children with systemic diseases such as immunodeficiency, cardiovascular disease, or bleeding disorders.
2. Children are allergic to nickel and resin.
3. Children unable to return for recall visits.
4. Primary molar has signs of pulpal/periapical diseases (irreversible pulpitis, pulp necrosis, loosening, fistula, or abscess).
5. Children are undergoing orthodontic treatment with fixed or removable appliances.

Primary outcomes:
measure: Failure of stainless steel crowns
timeFrame: 3 months
measure: Failure of stainless steel crowns
timeFrame: 6 months
measure: Failure of stainless steel crowns
timeFrame: 9 months
measure: Failure of stainless steel crowns
timeFrame: 12 months
Secondary outcomes:
measure: Occlusal contact
timeFrame: 0 months
measure: Occlusal contact
timeFrame: 3 months
measure: Occlusal contact
timeFrame: 6 months
measure: Occlusal contact
timeFrame: 9 months
measure: Occlusal contact
timeFrame: 12 months
measure: Periodontal health
timeFrame: 0 months
measure: Periodontal health
timeFrame: 3 months
measure: Periodontal health
timeFrame: 6 months
measure: Periodontal health
timeFrame: 9 months
measure: Periodontal health
timeFrame: 12 months
Other outcomes:
Locations:
city: Huế
country: Vietnam
facility: Hue University of Medicine and Pharmacy
state: Thua Thien Hue
Study officials:
References: