louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00557635: Osseous Setting Improvement With Co-implantation of Osseous Matrix and Mesenchymal Progenitors Cells From Autologous Bone Marrow
Official title: Osseous Setting Improvement With Co-implantation of Osseous Matrix and Mesenchymal Progenitors Cells From Autologous Bone Marrow
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
Conditions: Tibia or Femur Pseudo-arthrosis
Keywords: pseudo-arthrosis, osseous matrix, cell therapy
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2007-11-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Sometime osseous reconstruction needs allogeneic bone, in this study we use Ostéopure™ from Ostéobanque d'Auvergne, which is a osseous matrix. However Ostéopure™ integration lasts a long time. To optimize this integration we purpose to associate mesenchymal progenitors cells from autologous bone marrow.

Detailed description: All patients will be treated for tibia or femur pseudo-arthrosis. At the beginning of chirurgical intervention, autologous bone marrow will be sampling and will be concentrated during this one.

Meanwhile osseous matrix (Ostéopure™ ) will be incubated in autologous blood serum and finally implanted in the fracture site. And after (at the end of chirurgical intervention), concentrate autologous bone marrow will be injected in the same place.

Eligibility criteria: Inclusion Criteria:

* tibia or femur pseudo-arthrosis,
* patient who needs bone graft

Exclusion Criteria:

* - contra indications for chirurgical intervention or bone graft

Primary outcomes:
measure: Evaluate osseous setting at 3-months follow-up and compare our results with past studies
timeFrame: at 3-months follow-up
Secondary outcomes:
measure: Feasibility and tolerance of this therapeutic strategy
timeFrame: at 3-months follow-up
Other outcomes:
Locations:
Study officials:
name: Marc Berger, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05375435: Efficacy and Safety of Triple Therapy in Patients With Anti-MDA5 Antibody-positive Dermatomyositis
Official title: Efficacy and Safety of Triple Therapy Based on Prognostic Risk Stratification in Patients With Anti-MDA5 Antibody-positive Dermatomyositis: a Multicenter, Prospective, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Dermatomyositis, Adult Type
Interstitial Lung Disease
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2022-05-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We conduct this study to investigate the efficacy of triple therapy (high-dose glucocorticoids + cyclophosphamide + calcineurin inhibitor) compared with dual-therapy regimens (high-dose glucocorticoids + cyclophosphamide/calcineurin inhibitor) and whether it reduces the risk of poor pulmonary prognosis in patients with moderate to high risk anti-MDA5+ DM.


Eligibility criteria: Inclusion Criteria:

* Adult patients meet the diagnostic criteria for dermatomyositis of Bohan and Peter
* Anti-MDA5 Antibody-positive

Exclusion Criteria:

* Complicated with other connective tissue diseases
* Complicated with cardiovascular and respiratory disease caused by other reasons
* Interstitial lung disease caused by environment and drugs
* Patients with key research missing data or without informed consent

Primary outcomes:
measure: RPILD
timeFrame: 6 months
measure: Death
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital with Nanjing Medical University
state: Jiangsu
Study officials:
References:
Clinical trial NCT05420363: Influence of Surface Characteristics of Gait Training on Gait Kinematics and Walking Capacity in Children With Diplegic CP
Official title: Influence of Surface Characteristics of Gait Training on Gait Kinematics and Walking Capacity in Children With Diplegic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diplegic Cerebral Palsy
Keywords: CP , Diplegia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-06-15
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Using challenging surfaces of gait training, which require constant adjustments of the body's movement patterns to maintain stability and provide different sensory and proprioceptive inputs to mimic real life situation is appropriate for children with CP. So, the purpose of the current study is to investigate the influence of surface characteristics of gait training on gait kinematics and walking capacity in children with diplegic CP.

Detailed description: The purpose of the study is to determine the influence of surface characteristics (different surfaces materials and textures) of gait training on kinematics gait parameters (step length, step width, double support time and cadence) and the functional walking capacity in children with diplegic CP.

Eligibility criteria: Inclusion Criteria:

1. Their ages will range from 6 to 8 years old.
2. The degree of spasticity will range from grade 1 or 1+ according to Modified Ashworth Scale.
3. They will be at level II on GMFCS .
4. They will be able to follow verbal command or instructions.

Exclusion Criteria:

* 1. Fixed deformities of lower limbs. 2. Sever visual or auditory problems. 3. History of surgical interference in lower limbs less than one year. 4. Botulinum toxin injections to the lower limb during the previous 4 months.

Primary outcomes:
measure: kinematics gait parameters
timeFrame: over 3 months
measure: kinematics gait parameters
timeFrame: over 3 months
measure: kinematics gait parameters
timeFrame: over 3 months
measure: kinematics gait parameters
timeFrame: over 3 months
Secondary outcomes:
measure: Six-minute walking test
timeFrame: over 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university , Faculty of Physical Therapy
Study officials:
References:
Clinical trial NCT02137863: Efficacy of Dexmedetomidine in Preventing Contrast Induced Nephropathy
Official title: Phase 4 Study of Dexmedetomidine Effects on Preventing Contrast Induced Nephropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Radiographic Contrast Agent Nephropathy
Keywords: Contrast induced nephropathy
Diabetes Mellitus
Dexmedetomidine
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2014-05-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study was to evaluate the effects of dexmedetomidine on renal function, hormonal and hemodynamic parameters in contrast media induced diabetic patients.

Detailed description: Contrast nephropathy may occur after using intravenous contrast media and may result in acute renal failure. Contrast nephropathy usually reversible but in some cases it can be permanent. This situation increase the time of hospitalization and mortality of the patients. Although the only proved prevention from contrast nephropathy method is hydration, infusion of dexmedetomidine may keep the renal functions.

Eligibility criteria: Inclusion Criteria:

* Scheduled for percutaneous coronary angiography
* \> 18 yo
* Diabetic patients
* Creatinin value \< 3 mg/dl

Exclusion Criteria:

* Contrast agent hypersensitivity
* Pregnant patients
* Creatinin value ≥3mg/dl
* patients have acute renal failure

Primary outcomes:
measure: Changes in glomerular renal function after percutaneous coronary angiography as measured by neutrophil gelatinase-associated lipocalin, cystatin c, blood urea nitrogen, creatinin
timeFrame: 1 day (from start of angioplasty till discharge from the hospital)
Secondary outcomes:
measure: blood pressure
timeFrame: 1 day (from start of angiography till discharge from the hospital)
measure: Heart rate
timeFrame: 1 day (from start of angiography till discharge from the hospital)
measure: Blood electrolyte levels ( sodium, potassium, chloride)
timeFrame: before the angiography and just before the discharge from hospital
measure: complete blood count
timeFrame: before the angiography and just before the discharge from hospital
Other outcomes:
Locations:
Study officials:
affiliation: TC Erciyes University
name: Aynur Akın, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT04347863: Investigating Program of Food Preparation on Diet Improvement for Patients With Stroke
Official title: Investigating Program of Food Preparation on Diet Improvement for Patients With Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Dysphagia, Late Effect of Stroke
Keywords: Food preparation
Dietary well-being
Quality of life
Dysphagia
Stroke
Lead sponsor: Taiwan Adventist Hospital
Sponsor class: OTHER
First posted: 2020-04-15
Enrollment: 22
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled behavioral intervention trial to assess the efficacy of investigating program of food preparation on diet improve patients with stroke.

Detailed description: This is a randomized controlled behavioral intervention trial to assess the efficacy of investigating program of food preparation on diet improve patients with stroke. Subjects will be randomized to intervention group and control group.The primary outcome included seven measures, Functional oral intake scale, Mini Nutritional Assessment, Council on Nutrition Appetite Questionnaire, Dietary Well-Being Scale, Swallowing Quality of Life questionnaire, WHO Quality of Life-BREF and Eating Assessment Tool-10.

Eligibility criteria: Inclusion Criteria:

* Diagnosis is stroke
* EAT-10 ≥ 3
* Aged \> 20 years
* Capability of following instructions
* Willing to participants to the study

Exclusion Criteria:

* Non-stroke neurological diseases ( ex: traumatic brain injury, brain tumor, neurodegenerative disease and Parkinson's disease )
* Dysphagia by neck injury or surgery
* During the study, he/she was hospitalized again due to disease.

Primary outcomes:
measure: Changes of the Eating Assessment Tool-10
timeFrame: 6 weeks
measure: Changes of the Functional Oral Intake Scale
timeFrame: 6 weeks
measure: Changes of the Mini Nutritional Assessment
timeFrame: 6 weeks
measure: Changes of the Council on Nutrition Appetite Questionnaire
timeFrame: 6 weeks
measure: Changes of the Dietary Well-Being Scale
timeFrame: 6 weeks
measure: Changes of the Swallowing Quality of Life questionnaire
timeFrame: 6 weeks
measure: Changes of the WHO Quality of Life-BREF
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: National Taipei University of Nursing and Health Sciences
state: Beitou Dist
Study officials:
affiliation: National Taipei University of Nursing and Health Sciences
name: En-Chi Chiu, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03690063: Nice Human Immunodeficiency Virus (HIV) Cohort
Official title: Nice Human Immunodeficiency Virus (HIV) Cohort
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Human Immunodeficiency Virus
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2018-10-01
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients HIV innocents of any treatment and recently infected

Brief summary: Historically, the database on the HIV was organized within the framework of the medico-economic file of the human immunodeficiency (DMI-2), introduced jointly by the Direction of Hospitals (Mission AIDS) and the INSERM at the end of the 80s. Today this database is fed via the computerized medical record NADIS. Most part of the research works on the theme of the HIV take support on this database (DAD, EuroAIDS, Neuradapt).


Eligibility criteria: Inclusion Criteria:

* Enrol consecutive patients with a scheduled visit in the outpatient clinic (regardless of CD4 cell count and ART status).

Exclusion Criteria:

-

Primary outcomes:
measure: change of the clinico-biological signs of the patients
timeFrame: Each Year during 50 years
Secondary outcomes:
measure: number of the various type of adverse events related by type of treatments
timeFrame: Each Year during 50 years
Other outcomes:
measure: number of the various type of co-morbidity
timeFrame: Each Year during 50 years
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
References:
Clinical trial NCT01587963: High Dose Vitamin C in the Critically Ill Patient
Official title: The Efficacy of High Dose Vitamin C in the Critically Ill Patient Population
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Shock
Keywords: hypovolemic or septic
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2012-04-30
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the effectiveness of high doses of Vitamin C in critically ill patients.

Detailed description: It has been shown that the stress that occurs during trauma, infection and/or shock depletes many of the body's resources such as Vitamin C (ascorbic acid) which may contribute to further complications. The purpose of this study is to determine the effectiveness of high doses of Vitamin C in critically ill patients.

Eligibility criteria: Inclusion Criteria:

* Activation of the Mass Transfusion Protocol following surgery or trauma.
* Diagnosis of septic shock. Septic shock will be defined as sepsis induced hypotension (i.e. systolic blood pressure \<90mmHg or drop of systolic blood pressure \>40mmHg in the presence of infection) that does not respond to a 2 liter fluid bolus.

Exclusion Criteria:

* Age less than 18 years.
* Pregnant women.
* Creatinine of greater than 2.2 g/dl at time of enrollment, history of chronic kidney or end stage renal disease, rise in creatinine \> 1 g/dl within 24 hours prior to enrollment.
* Brain death diagnosed within 4 hours of presentation to the trauma bay or intensive care unit
* Patients with history of hemolytic blood disease, e.g. glucose-6-phosphate dehydrogenase deficiency, Sickle Cell Disease and Thalassemia.
* Patients in isolated cardiogenic shock.
* History of liver cirrhosis
* Transplant patients (liver, kidney, heart)

Primary outcomes:
measure: Efficacy of High Dose Vitamin C Therapy in Shock Patients
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Robert Wood Johnson University Hospital
state: New Jersey
Study officials:
affiliation: RWJMS
name: Vicente Gracias, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01983163: Dietary Therapy in Children With Refractory Epilepsy
Official title: Efficacy of Modified Atkins Diet Versus Ketogenic Diet in Children With Refractory Epilepsy Aged 1 Year to 18 Years: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Epilepsy
Lead sponsor: All India Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2013-11-13
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In children aged 1yr -18 years with refractory epilepsy Modified Atkins diet as add on to ongoing AED therapy would not be inferior compared to ketogenic diet \*\* in terms of seizure reduction from baseline seizure frequency at 6 months

Detailed description: Primary objective:

To compare the efficacy of Modified Atkins diet compared to Ketogenic diet \* in children aged 1 year to 18 years of age with refractory epilepsy on anti epileptic drugs at 6 months of diet intake in terms of percentage of seizure reduction from base line.

Secondary objective:

Proportion of patients who achieve \> 50% seizure reduction from baseline after 6 months in both groups To evaluate the nature of adverse events in both the groups

Eligibility criteria: Inclusion Criteria:

* Children aged 1-18 years with refractory epilepsy\*
* Willing to come for regular follow up
* No motivational or psychosocial issues in the family which would preclude compliance with the diet

Exclusion Criteria

* Surgically remediable cause for refractory epilepsy
* Suspected mitochondrial disorder or diagnosed with a disorder in which high fat diet is contraindicated
* Previously received ketogenic diet or modified Atkins diet
* Chronic systemic disease like chronic kidney disease, chronic liver disease, heart disease (congenital and acquired) and chronic respiratory illness

Primary outcomes:
measure: Percentage of seizure reduction at 6 months ( sz frequency / wk average of 4 wks) from base line
timeFrame: Baseline and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
state: Delhi
Study officials:
affiliation: AIIMS, New Delhi
name: Sheffali Gulati, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05028335: Effect of 1.5% Potassium Oxalate on the Control of Tooth Sensitivity and Color Change After Home Bleaching
Official title: Effect of 1.5% Potassium Oxalate on the Control of Tooth Sensitivity and Color Change After Home Bleaching: a Randomized, Placebo-controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dentin Sensitivity
Lead sponsor: Universidade Federal do Para
Sponsor class: OTHER
First posted: 2021-08-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This double-blind randomized clinical trial evaluated the effect of 1.5% potassium oxalate on pain sensitivity control and color change after home tooth whitening. It also evaluated the influence of potassium oxalate on health-related quality of life (HRQOL) and on the degree of patient satisfaction after bleaching treatment.


Eligibility criteria: Inclusion Criteria:

* individuals aged 18 to 29 years of both sexes with chroma greater than A2 in the upper incisors and canines, in the Vita Classical color scale;
* absence of active caries lesions
* patients who had never undergone bleaching therapy;
* good oral hygiene and no hypersensitivity to tactile and evaporative stimuli through the Visual Analog Pain Scale;

Exclusion Criteria:

* patients undergoing fixed orthodontic treatment;
* patients with darkened non-vital teeth and/or with extensive restorations in molars;
* presence of cracks or fractures;
* patients allergic to the product, with the presence of gastroesophageal disorders and with dentinal exposure in anterior and/or posterior teeth.

Primary outcomes:
measure: dentin sensitivity
timeFrame: 21 days after the start of the whitening treatment
measure: dental color assessment
timeFrame: 21 days and 1 month after the bleaching treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Belém
country: Brazil
facility: Federal University of Pará
state: Pará
Study officials:
References:
Clinical trial NCT05684835: Radiographic Prediction of the Nerve Origin of Neck Peripheral Nerve Sheath Tumors
Official title: Radiographic Prediction of the Nerve Origin of Neck Peripheral Nerve Sheath Tumors: Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peripheral Nerve Sheath Tumors
Schwannoma of Neck
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2023-01-13
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with an intraoperatively confirmed neck PNST and NO between January 2008 and December 2022 who underwent surgical excision of neck PNST with anterior approach, excluding patients with previous anterior neck surgery, malignant disease, prior neck radiation, and undetermined intraoperative NO.

Brief summary: Postoperative nerve palsy is a major complication following resection of neck peripheral nerve sheath tumors. This study is a retrospective cohort aimed to predict the nerve origin of neck peripheral nerve sheath tumors. Accurate preoperative identification of the nerve origin can improve surgical outcomes and patient counseling

Detailed description: Postoperative nerve palsy is a major complication following resection of neck peripheral nerve sheath tumors (PNSTs). Accurate preoperative identification of the nerve origin (NO) can improve surgical outcomes and patient counseling. This study aims to predict the NO of neck PNSTs with radiographic analysis. This study is a retrospective cohort analysis. Radiographic parameters will be reviewed and the sensitivity, specificity, accuracy of NO prediction will be evaluated.

Eligibility criteria: Inclusion Criteria:

* Patients with clinical diagnosis of neck peripheral nerve sheath tumors.
* Patients received surgery January 2008 and December 2022.
* The nerve origin of peripheral nerve sheath tumor must be intraoperatively confirmed.

Exclusion Criteria:

* Previous anterior neck surgery.
* Malignant disease.
* Prior neck radiation.
* Undetermined intraoperative nerve origin.

Primary outcomes:
measure: Nerve origin
timeFrame: within 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Cheng-Kung University Hospital
Study officials:
References: