louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02926976: The Optimal Treatment for Treatment-resistant Schizophrenia
Official title: The Optimal Treatment for Treatment-resistant Schizophrenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Keywords: Schizophrenia
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2016-10-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Optimal Treatment for Treatment-resistant Schizophrenia

Detailed description: To explore the curative effect and safety of Risperidone，aripiprazole，sodium valproate，modified electroconvulsive therapy(MECT), or Magnetic seizure therapy(MST) with Clozapine in the treatment of treatment-resistant schizophrenia， and to provide the basis for clinical medication.

Eligibility criteria: Inclusion Criteria:

* The diagnosis of schizophrenia according to DSM-V
* 18～60 years old
* 2 prior failed treatment trials with 2 different antipsychotics at doses of at least 600 mg/day chlorpromazine equivalents, each of at least 6 weeks duration;
* Signed an informed consent

Exclusion Criteria:

* patients to be diagnosed according to DSM-V for substance abused, development delayed
* suffering from serious physical disease and can not accept the treatment
* MST contraindications: intracranial metal substance, with heart pacemakers and cochlear implants, intracranial pressure
* allergic to risperidone ,aripiprazole, or sodium valproate
* Participated in any clinical subject within 30 days
* Pregnancy or lactation

Primary outcomes:
measure: Change from baseline in Positive and Negative Syndrome Scale [PANSS]
timeFrame: At baseline, 4th week, 8th week,12th week
Secondary outcomes:
measure: Change from baseline in clinical global impression [CGI]
timeFrame: At baseline, 4th week, 8th week,12th week
measure: Change from baseline in Simpson-Angus Scale [SAS]
timeFrame: At baseline, 4th week, 8th week,12th week
measure: Change from baseline in Abnormal Involuntary Movement Scale[AIMS]
timeFrame: At baseline, 4th week, 8th week,12th week
Other outcomes:
Locations:
city: Shanghai
country: China
facility: DTliu
Study officials:
References:
Clinical trial NCT03155776: Estimation of Preoperative Gastric Volume Using Ultrasound
Official title: Ultrasound Assessment of Gastric Volume in Infants Undergoing General Anesthesia: Validation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fasting
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-05-16
Enrollment: 200
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants undergoing general anesthesia for abdominal surgery

Brief summary: Aspiration of gastric contents can be a serious anesthetic related complication. Gastric antral sonography prior to anesthesia may have a role in identifying pediatric patients at risk of aspiration. The investigator examined the relationship between sonographic antral area and endoscopically suctioned gastric volumes infants.


Eligibility criteria: Inclusion Criteria:

* Infants undergoing general anesthesia with endotracheal intubation were included in this study

Exclusion Criteria:

* a recent (≤1 month) history of oesophageal or gastric surgery, gastrostomy or ileostomy, diaphragmatic hernia, emergent surgery, or a prolonged duration (\>5 min) between completion of US assessment and suctioning of gastric contents

Primary outcomes:
measure: gastric antral cross sectional area
timeFrame: immediate after anesthetic induction within 1 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jin-Tae Kim
Study officials:
References:
citation: Kim EH, Yoon HC, Lee JH, Kim HS, Jang YE, Ji SH, Cho SA, Kim JT. Prediction of gastric fluid volume by ultrasonography in infants undergoing general anaesthesia. Br J Anaesth. 2021 Aug;127(2):275-280. doi: 10.1016/j.bja.2021.03.039. Epub 2021 May 25.
Clinical trial NCT01762176: Early RA MRI Early Intensive Treatment Study
Official title: Effect of Early Intensive Treatment in Chinese Patients With Recent-onset Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early Rheumatoid Arthritis
Keywords: Early Rheumatoid Arthritis
Usual care
Intensive Care
Boolean criteria
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2013-01-07
Enrollment: 163
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the effectiveness of two treatment strategies in early rheumatoid arthritis (ERA), namely the delayed usual care and early intensive care, in Hong Kong.

* The delayed usual care reflects the usual treatment practice in Hong Kong
* The early intensive care includes tight monitoring and immediate adjustment of therapy

Detailed description: This study is a 1-year non-randomized clinical trial. Two groups of patients (delayed usual care and early intensive care) with diagnosis of rheumatoid arthritis (RA) and with symptoms onset of less than 2 years and disease modifying anti-rheumatic drugs (DMARDs) naive will be recruited. Remission is reached if patients fulfill the Boolean criteria.

Eligibility criteria: Inclusion Criteria:

For usual care group:

* patients with at least 1 tender and swollen joint
* duration of symptoms less than 2 years
* no previous use of DMARDs

For intensive care group:

* patients with at least 1 tender and swollen joint
* duration of symptoms less than 2 years
* no previous use of DMARDs
* patients who fulfill the 2010 ACR/EULAR classification criteria for RA

Exclusion Criteria:

* patients with renal impairment (on dialysis or estimated Glomerular Filtration Rate (eGFR) \<30 mL/min/1.73m\^2)

Primary outcomes:
measure: The proportion of patients who achieve clinical remission
timeFrame: 12 months
Secondary outcomes:
measure: Change in various patient-reported outcomes
timeFrame: 12 months
measure: Gains in utility
timeFrame: 12 months
measure: Radiographic progression
timeFrame: 12 months
measure: ACR 20, 50, 70 responses
timeFrame: 12 months
measure: MRI outcome
timeFrame: 12 months
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Lai Shan Tam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06910176: Confirming And Notifying Death
Official title: Confirming And Notifying Death : Blended Learning and Its Evaluation by Medical Students, an Acceptability Study"
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Notifying Death to Loved Ones
Keywords: Notifying Death
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 20
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: Student having taken the national ECOS (thus becoming an intern at the start of the following academic year in November 2024),

Brief summary: Most physicians are confronted with the death of patients during their practice, often as early as residency. It is their legal responsibility to certify a patient's death, as well as often to notify their loved ones.

Yet, these duties currently receive little or no specific training during the various cycles of medical education.

This task is not easy, however, and young professionals experience it with difficulty. Literature data show that residents are confronted with death late in their medical education and that they are insufficiently prepared when they have to perform their first death certificate. Indeed, residents report significantly correlated practical and emotional difficulties. These difficulties are notably linked to a feeling of lack of preparation through theoretical courses, a lack of familiarity with administrative procedures, and insufficient mastery of communicating with families. The highlighting of these difficulties and the desire for appropriate and respectful care for the deceased and their families, for whom the moment of announcement influences the experience of grief, call for an improvement in teaching on these topics. It is in this sense that the project was born to explore whether the creation of training, before their independent exposure to death and its announcement, i.e. at the end of the second cycle, was relevant. A prerequisite for this type of training project is indeed to question the acceptability of such an approach by students.


Eligibility criteria: Inclusion Criteria:

* DFASM3 student,
* At the Faculty of Medicine of Strasbourg, France, for the 2023-2024 academic year,
* Having taken the national ECOS (thus becoming an intern at the start of the following academic year in November 2024),
* Aged 18 years or older,
* Not opposed to participating in the study.
* Not having completed an internship in specialized palliative care facilities

Exclusion Criteria:

* Refused to participate in the study.
* Not having taken the national ECOS.

Primary outcomes:
measure: To assess the acceptability of training in death certification and death notification to relatives by DFASM3 students in Strasbourg.
timeFrame: At 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de soins Palliatifs - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT00594776: Vascular CT Assessment of Structural Autograft and Allograft Healing
Official title: Vascular CT Assessment of Structural Autograft and Allograft Healing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Tumors
Keywords: Cone Beam CT
CBCT
Bone Tumors
Autographs
Allographs
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2008-01-16
Enrollment: 8
Sex: ALL
Minimum age (years): 10
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are recruited from the general practice of 3 of our investigators. Patients will have received an structural allograft or vascularized autograft for the treatment of bone cancer.

Brief summary: The purpose of this study is to determine the ability of a cone beam CT to measure bone healing.

Detailed description: The purpose of this study is to investigate quantitative vascular cone beam CT(CBCT) in a clinical pilot of patients that have received a structural allograft for bone cancer or a vascularized structural autograft for bone cancer or traumatic injury. Development of a minimally invasive, longitudinal outcome measure to quantify intramedullary vascular volume and cortical bone volume of structural allografts in patients is required to translate "revitalizing" structural allograft in clinical trials. Our novel vascular CBCT will be able to demonstrate the significant differences between vascularized fibular autografts vs. structural allografts in patients that will undergo structural grafting. These data will be used to devise a power calculation for a definitive clinical trial to evaluate the efficacy of the revitalizing allograft.

Eligibility criteria: Inclusion Criteria:

* male or female
* all races will be included
* autograft or allograft of long bone as part of treatment for bone tumor

Exclusion Criteria:

* pregnancy
* patients with a history of IV contrast reactions
* contraindication to use of epinephrine or diphenhydramine
* hypertyroidism or history of sensitivity to iodine
* kidney disease (abnormal urinalysis or calculaged GFR) or poor hydration due to poor intake or other causes

Primary outcomes:
measure: Change in intramedullary vascular volume and new bone growth based on CBCT
timeFrame: 2, 8 & 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Edward Schwarz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04002076: Effectiveness of Robot-assisted Rehabilitation in Persons With Stroke
Official title: Effectiveness of Robot-assisted Rehabilitation on Upper Limb Function and Neuroplasticity in Persons With Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: stroke
Robot-assisted Rehabilitation
Lead sponsor: Taipei Medical University Hospital
Sponsor class: OTHER
First posted: 2019-06-28
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to investigate the effects of robot-assisted hand with visual feedback intervention on cortical excitability, brain structure, spasiticity, gross and fine motor of upper limb and hand in individuals with stroke. Twenty participants will be recruited in this study. They will be allocated to two group: robot-assisted hand combined with traditional occupational therapy group (10), only traditional occupational therapy group (10).

Detailed description: Participants will be randomized allocated to two groups: robot-assisted hand combined with traditional occupational therapy (OT) group and traditional OT group. All participants underwent six weeks, 3 sessions per week, and 60 minutes per session training program. Motor Evoked Potential (MEP), Fugl-Meyer Assessment (FMA), Modified Ashworth Scale (MAS), Box and Block Test (BBT) and Purdue Pegboard Test (PPT) will be assessed before and after intervention in all participants.

Eligibility criteria: Inclusion Criteria:

1. Mini-Mental State Examination score is above 23
2. A first-ever stroke with unilateral hemiplegia or hemiparesis.
3. Medical and psychological condition is stable.

Exclusion Criteria:

1. Balance and walking ability affected by other neurological problems
2. Functional performance affected by medication or medical condition 3 Unable to tolerate rehabilitation.

4. Severe hearing or visual problem. 5. Having pacemaker.

Primary outcomes:
measure: Change of Box and Block Test (BBT)
timeFrame: Measurement before and after intervention ( week 0 and at the end of week 6) in both groups
measure: Change of Motor evoked potential (MEP)
timeFrame: [Time Frame: Measurement before and after intervention ( week 0 and at the end of week 6) in both groups]
Secondary outcomes:
measure: Change of Purdue Pegboard Test (PPT)
timeFrame: Measurement before and after intervention ( week 0 and at the end of week 6) in both groups
measure: Change of Modified Ashworth Scale (MAS)
timeFrame: Measurement before and after intervention ( week 0 and at the end of week 6) in both groups
measure: Change of Fugl-Meyer Assessment (FMA)-Upper extremity
timeFrame: Measurement before and after intervention ( week 0 and at the end of week 6) in both groups
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical university Hospital
Study officials:
References:
Clinical trial NCT02002676: Prevalence and Outcome of Hypermetabolism in Initial Prevalence and Outcome of Hypermetabolism in Initial Phase of Intensive Care Unit Patient: a Prospective Observational Study
Official title: Prevalence and Outcome of Hypermetabolism in Initial Phase of Intensive Care Unit Patient: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SIRS
Sepsis
Septic Shock
Keywords: rest energy expenditure,critical ill, outcome
Lead sponsor: Nanjing University School of Medicine
Sponsor class: OTHER
Collaborators: name: Jinling Hospital, China
First posted: 2013-12-06
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who admitted ICU with hypermatebolic status, which the results of indirect calorimetry show that the actual rest energy expenditure values are remarkably higher than the predicted ones.

Brief summary: Patients in critical illness frequently present hypermetabolism， which can extremely increase the rest energy expenditure（REE）. We hypothesize that if we alleviate the extremely increased REE will improve ICU patients' outcome

Detailed description: This study focuses on the early changes of REE of critical ill patients when they admitted to ICU.

Eligibility criteria: Inclusion Criteria:

* Older than 18 year.
* APACHEⅡ score≥8

Exclusion Criteria:

* Hypercortisolism
* Thyroid disease
* Tracheoesophageal fistula
* FiO2\>60 or PEEP\>12cm H2O in mechanical ventilate
* Pregnancy

Primary outcomes:
measure: Mortality rate of 28 days
timeFrame: From ICU admission to 28th days of observation
Secondary outcomes:
measure: Incidence of Multiple Organ Dysfunction Syndrome（MODS）in 60 days
timeFrame: From ICU admission to 60th days of observation
Other outcomes:
measure: Length of stay in ICU
timeFrame: Length of ICU stay within 60 days
Locations:
city: Nanjing
country: China
facility: Nanjing University School of Medicine
state: Jiangsu
Study officials:
affiliation: Nanjing University School of Medicine
name: Xinying Wang, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05009576: Comparative Study Using Negative Pressure Dressing With & Without Silver Alginate to Promote Healing in Chronic Wounds.
Official title: Comparative Study Using Negative Pressure Dressing With & Without Silver Alginate to Promote Healing in Chronic Wounds.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Healing
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2021-08-17
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The randomized control trial will be conducted in the Department of Plastic and Reconstructive Surgery at Dr. Ruth K.M. Pfau Civil Hospital Karachi.General population admitted in Civil Hospital Karachi, for wound coverage with skin grafting meetimg inclusion criteria will be included.

Detailed description: Wound will be covered with negative pressure dressings that are composed of a sterile foam dressing surrounded by an occlusive film that adheres to the nearby, normal skin. Suction is applied to the dressing and a draining tube connect to a wall fixed assisted vacuum canister.

Patients will be provided with paper chits with A or B marked on it. Patients picking up A chit will be dealt as A group where wound will be covered with VAC dressings only where by patients picking up B chit will be dealt as B group where wound will be covered with a single layer of Ag+ hydrocolloid dressings. Such pattern of dressing will be followed in every change of dressing in 48 hours. The wound site will be photographed after every change of dressings. The wound site will be photographically monitored by a team of plastic surgeons to assess granulation tissue, by noting the size of wound, color and shine of granulation tissue and edema.

Eligibility criteria: Inclusion Criteria:

* Both genders above 18 years
* Wounds for more than 6 weeks
* History of trauma, tumor, congenital physical abnormalities
* Hemoglobin levels more than 10 g/dl
* Platelet count above 150 x 10E9/L
* Size of wound \> 10\*10cm.

Exclusion Criteria:

* Pressure ulcers
* Co-morbidities like diabetes or hypertension
* Bleeding vessels
* Presence of Necrotic tissue
* Malignancy in wounds

Primary outcomes:
measure: Granulation tissue
timeFrame: 6 days
measure: size of wound.
timeFrame: 6 days
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Mahak
state: Sindh
Study officials:
References:
Clinical trial NCT06238076: Evaluation of an Universal Surgical Device for Mandibular Reconstruction.
Official title: Universal Surgical Device for Mandibular Reconstruction Using Fibula Free Flap : Feasibility Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mandibular Reconstruction
Keywords: Mandible
Mandibular Reconstruction
Computer-Aided Design
Fibular free flap
Computer Assisted three dimensional imaging
Surgical equipment
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2024-02-02
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility pilot study, monocentric, non-comparative
Primary purpose: OTHER

Brief summary: Fibula free flap is the gold standard for mandibular reconstruction. The shape of the fibula requires osteotomy that can be performed with a custom surgical guide. The use of surgical guide shorten surgical time, enhances the precision of the surgeon and reduces morbidity.

Since 2008 custom surgical guide have been used in the hospital department and the clinical team have noticed a number of elements, which leads investigator to think that it would be possible to perform this kind of procedure using an universal guide.

The aim of this study is to assess the possibility to perform mandibular fibula free flap reconstruction with an universal guide.


Eligibility criteria: Inclusion Criteria:

* Admitted in the maxillofacial surgery department for mandibular fibula free flap reconstruction including a symphysial bone fragment
* Patients insured under the French social security system
* Free and informed consent

Exclusion Criteria:

* Lateral mandibular reconstruction without symphysis reconstruction
* Legally incompetent
* Inclusion in another protocol of research , involving mandibular reconstruction
* Pregnant or breastfeeding women

Primary outcomes:
measure: Feasibility of guiding mandibular fibula free flap reconstruction with an universal guide.
timeFrame: Day 1
Secondary outcomes:
measure: Time of surgical procedure
timeFrame: Day 1
measure: Qualitative assessment of the device by the surgeon
timeFrame: Day 1
measure: Post-operative quality of life
timeFrame: From 6 to 8 weeks
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Alice PREVOST, MD
role: PRINCIPAL_INVESTIGATOR
References: