louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01477905: Impact of Priming the Infusion System on the Performance of Target-controlled Infusion of Remifentanil
Official title: Study of Proper Operation of the Syringe Pump Used in Priming of the Syringe
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intravenous Drug Usage
Keywords: priming
remifentanil
target-controlled infusion
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2011-11-23
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators attempted to determine an adequate priming volume for our infusion system, and investigated the extent of a possible delay of the drug effect, that would result from mechanical defects of the infusion system, with or without priming the infusion system, using direct gravimetrical measurements of virtual infusate amounts during target controlled infusion of 2 remifentanil diluents.

Detailed description: Priming the infusion system (PRIMING) was performed using an evacuation of 2.0 ml to the atmosphere prior to Target-controlled Infusion (TCI). Forty eight TCI, using 50 μg/ml or 20 μg/ml of remifentanil diluents, were performed targeting 4.0 ng/ml of effect site concentration (Ceff), with or without PRIMING. Using simulations, the gravimetrical measurements of the delivered infusates reproduced actual predicted concentrations.

Eligibility criteria: Inclusion Criteria:

* electric medical records of the patients who had undergone general anaesthesia

Exclusion Criteria:

* body weight exceeding 20% of ideal body weight

Primary outcomes:
measure: delivered infusates of remifentanil
timeFrame: base line from 30 min of TCI was maintained
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University School of Medicine
Study officials:
affiliation: Ajou University School of Medicine
name: Jong Yeop Kim, M.D.
role: STUDY_DIRECTOR
References:
citation: Swinhoe CF, Peacock JE, Glen JB, Reilly CS. Evaluation of the predictive performance of a 'Diprifusor' TCI system. Anaesthesia. 1998 Apr;53 Suppl 1:61-7. doi: 10.1111/j.1365-2044.1998.53s104.x.
Clinical trial NCT03687905: Proliferative Lupus Nephritis Treatment With Chloroquine and Hydroxychloroquine
Official title: Comparative Study Between Chloroquine and Hydroxychloroquine as Therapeutic Modalities for Children and Adolescents With Proliferative Lupus Nephritis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Proliferative Nephritis
Chloroquine Retinopathy
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2018-09-27
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: • All patients will fulfill the diagnostic criteria of SLE. The diagnosis of systemic lupus erythematosus is based on clinical and laboratory criteria. The criteria set developed by the American College of Rheumatology (ACR) and diagnosed wih lupus nephritis class III and IV

Brief summary: Evaluation the efficacy of chloroquine and hydroxychloroquine in the treatment of proliferative lupus nephritis class III and IV in children and adolescents and evaluate the side effects of both drugs .

Detailed description: All patients will fulfill the diagnostic criteria of SLE. The diagnosis of systemic lupus erythematosus is based on clinical and laboratory criteria. The criteria set developed by the American College of Rheumatology (ACR) and diagnosed wih lupus nephritis class III and IV .

Inclusion Criteria:

* Children and adolescents who fulfill diagnostics criteria of SLE and diagnosed with lupus nephritis class III and IV.
* All patients will be received steroids , MMF and Angiotensin Converting Enzyme.

Exclusion Criteria:

* Patients diagnosed with lupus nephritis class I,II,V and VI.
* Patients received Cyclophosphamide in stead of MMF.

Eligibility criteria: Inclusion Criteria:

* Children and adolescents who fulfill diagnostics criteria of SLE and diagnosed with lupus nephritis class III and IV.
* All patients will be received steroids , MMF and Angiotensin Converting Enzyme.

Exclusion Criteria:

* Patients diagnosed with lupus nephritis class I,II,V and VI.
* Patients received Cyclophosphamide in stead of MMF.

Primary outcomes:
measure: Fundus examination as screening test
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Fatma Gheet
Study officials:
affiliation: Tanta University
name: Fatma S Gheet, M.B.,BCh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05931705: Vit D Receptor Gene Polymorphism
Official title: Vit D Receptor Gene Polymorphism and Its Possible Association With Prevalence of Dental Caries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitamin D Status
Keywords: Vitamin D Gene Polymorphism
Dental Caries
Cathelicidins
Lead sponsor: Ajman University
Sponsor class: OTHER
First posted: 2023-07-05
Enrollment: 376
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population included participants with active dental caries and associated wasting disease of the teeth due to caries

Brief summary: The present cross-sectional observational study was conducted after the university ethical committee approved the research (NU/CEC/2020/0339). This study included 376 adults in the age group of 18-40Yrs. The patient information sheet briefed the study details and usage of salivary samples. Informed consent was obtained from participants. Healthy individuals free of associated systemic conditions, individuals not under any nutritional supplementation were included in the study, and lactating mothers, smokers, and menopausal women were excluded

Detailed description: The present cross-sectional observational study was conducted after the university ethical committee approved the research (NU/CEC/2020/0339). This study included 376 adults in the age group of 18-40Yrs. The patient information sheet briefed the study details and usage of salivary samples. Informed consent was obtained from participants. Healthy individuals free of associated systemic conditions, individuals not under any nutritional supplementation were included in the study, and lactating mothers, smokers, and menopausal women were excluded.

Further, the subjects were divided into active and caries-free based on caries experience. Two indexing methods were utilized to record the decay status, i.e., Decay, Missing, filled (DMFT) and Pulpal, Ulcerative, Fistula (PUFA) scores. Caries active group was further divided into a High-risk group (DMFT=\< 10), Moderate risk (DMFT= 4-9), and Low risk (DMFT=1-3).

Questionnaire: Baseline information was gathered, including specifics on age, sex, height, weight, dietary preferences (non-veg/veg), and dental hygiene practices.

Eligibility criteria: Inclusion Criteria:

* Healthy individuals free of associated systemic conditions
* Individuals not under any nutritional supplementation

Exclusion Criteria:

* lactating mothers
* smokers
* menopausal women

Primary outcomes:
measure: DMFT scores
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Mangaluru
country: India
facility: AB shetty Institute of dental sciences
state: Karnataka
Study officials:
References:
Clinical trial NCT01154205: Sheba Medical Center Home Monitoring Clinic Registry
Official title: Sheba Medical Center Home Monitoring Clinic Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Clinical Workload Assessment Based Upon a Home Monitoring System
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-06-30
Enrollment: 100
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 implanted with an ICD or CRTD.

Brief summary: The purpose of the registry is to assess workload of a Home Monitoring based follow up for Biotronik ICD and CRTD patients.


Eligibility criteria: Inclusion Criteria:

* Approved indication for ICD or CRTD
* Implanted with or replaced with a Biotronik Lumax device
* Patient willing and able to sign consent form
* Willing and able to attend clinic visits and follow up schedule
* Transmission of more than 80% at 3-month follow up
* Patient older than 18 years

Exclusion Criteria:

* no indication for ICD or CRTD implant
* Life expectancy shorter than 12 months
* Pregnancy
* Participation in other clinical studies

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tel HaShomer
country: Israel
facility: Sheba Medical Center
state: Ramat Gan
Study officials:
References:
Clinical trial NCT01669005: The Utility of Multiplex PCR for Detection of DNA in Neutropenic Patients With Hematological Malignancies
Official title: Obtaining Early Diagnosis and Prognosis in Urgent Sepsis (OEDIPUS) Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neutropenia
Keywords: neutropenia
multiplex PCR
infection
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
Collaborators: name: University Hospital, Basel, Switzerland
First posted: 2012-08-20
Enrollment: 84
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized in the bone marrow transplant unit in the study period

Brief summary: Objectives: Invasive infections are the leading cause of morbidity and mortality in patients treated for hematological malignancies. Blood cultures are often negative in neutropenic patients because of low-burden of organisms, previous antibiotic therapy or non-infectious reason of fever. More rapid, accurate and sensitive diagnostic tools are needed.

Hypothesis: Multiplex real-time PCR may detect microbial DNA in neutropenic patients before febrile episode. To investigate this hypothesis, EDTA-blood was routinely collected for multiplex PCR at admission and 3x/week thereafter until discharge or recovery from neutropenia


Eligibility criteria: Inclusion Criteria:

* patients aged ≥18 years
* autologous or allogeneic hematopoietic stem cells transplantation or induction/consolidation chemotherapy performed

Exclusion Criteria:

* No blood samples were taken

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital Lausanne, Switzerland
name: Andrej Trampuz, MD
role: STUDY_DIRECTOR
affiliation: University Hospital Lausanne, Switzerland
name: Christina Orasch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05121805: Recurrences After Standard EMR vs Plus Thermal Ablation EMR
Official title: Recurrences After Standard EMR vs Plus Thermal Ablation EMR of Advanced Sessile and Lateral Spreading Colorectal Adenoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polyps of Colon
Recurrence, Local Neoplasm
Keywords: Snare tip soft coagulation
EMR
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Maas Hospital Pantein
name: Evangelisches Krankenhaus Düsseldorf
name: Catharina Ziekenhuis Eindhoven
name: Bernhoven Hospital
name: Maasstad Hospital
name: St Jansdal Hospital
name: Bravis Hospital
First posted: 2021-11-16
Enrollment: 306
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: The primary objective of this trial is to investigate whether thermal ablation EMR with soft tip snare coagulation (STSC) reduces the recurrence rate of lateral spreading or sessile polyps ≥20mm compared to standard EMR.

Detailed description: Rationale:

Lowering the EMR recurrence rate will potentially lead to fewer colonoscopies resulting in less additional costs, less compliance burdens and less exposure to possible procedure related risks.

Objective:

To investigate whether thermal ablation EMR with snare tip soft coagulation (STSC) reduces the recurrence rate of lateral spreading or sessile polyps ≥20mm compared to standard EMR.

Study design:

This study entails a patient-blinded multicenter prospective randomized controlled trial that will be conducted between January 2022 and May 2025 in 1 academic and 7 non-academic hospitals in The Netherlands and it will take place in the outpatient clinics of the participating centers.

Study population:

All patients aged ≥ 18 years with proven colorectal sessile of lateral spreading polyps (Paris classification 0-IIa/b/c, Is) with a diameter of ≥ 20mm requiring piecemeal resection with EMR are eligible for inclusion.

Intervention:

Snare tip soft coagulation of the entire EMR margin is a technique for the removal of potential residual adenoma.

Main study endpoint:

Polyp recurrence after 6 months follow up. Recurrence is evaluated histologically and endoscopically with biopsies taken during follow up colonoscopy.

Eligibility criteria: Inclusion Criteria:

* Proven colorectal sessile or lateral spreading polyps with a diameter of ≥ 20mm requiring piecemeal resection with EMR.

Exclusion Criteria:

* Previously attempted intervention
* Polyps with any signs of invasive malignancy
* Presence or suspicion of inflammatory bowel disease
* En bloc resection
* Incomplete resection

Primary outcomes:
measure: Recurrence
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Peter Siersema
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05375305: A Study of SHR8554 Injection for the Treatment of Pain After Orthopedic Surgery
Official title: A Phase II/Ⅲ, Randomized, Double-Blind, Dose-explored, Active-controlled Study of SHR8554 Injection for the Treatment of Pain After Orthopedic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pain
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-05-16
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: The primary objective is to evaluate the analgesic efficacy of IV SHR8554 compared with morphine and placebo in patients with acute postoperative pain following orthopedic surgery.


Eligibility criteria: Inclusion Criteria:

1. Able and willing to provide a written informed consent
2. Subjects requiring elective general anesthesia orthopedic surgery
3. Conform to the ASA Physical Status Classification

Exclusion Criteria:

1. Subjects with a history of difficult airway
2. Subjects with a history of reflux esophagitis
3. Subjects with a history of mental illness
4. Subjects with poor blood pressure control
5. Transcutaneous oxygen saturation (SpO2) \<90%
6. Random blood glucose ≥11.1mmol/L
7. Subjects with abnormal liver function
8. allergies to opioids and other medications that may be used during the trial

Primary outcomes:
measure: the Sum of Pain Intensity Differences in Pain Score Over 48 Hours in the rest state
timeFrame: 48-hours
Secondary outcomes:
measure: the Sum of Pain Intensity Differences in Pain Score Over 6、12、24、 48 、12-24、24-48 Hours under static and moving condition
timeFrame: 48-hours
measure: Time of first use of remedial analgesic medication
timeFrame: 48-hours
measure: Cumulative use of remedial analgesics from 0h to 48h
timeFrame: 48-hours
measure: Participant ' satisfaction score for analgesia treatment
timeFrame: 48-hours
measure: Investigator satisfaction score for analgesia treatment
timeFrame: 48-hours
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Jiaotong University School of Medicine,Renji Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT05845905: Effects of Remote Ischemic Conditioning on Blood Pressure in Older Patients With Hypertension
Official title: Effects of Remote Ischemic Conditioning on Blood Pressure in Older Patients With Hypertension
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Essential Hypertension
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 158
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to learn about effects of remote ischemic conditioning on blood pressure in older patients with essential hypertension.

Detailed description: Current studies have shown that remote ischemic conditioning can improve vascular endothelial function and inhibit sympathetic nervous system activity. Thus it may provide some organ protection as well as anti-hypertensive effects. The purpose of this study is to learn about effects of remote ischemic conditioning on blood pressure in older patients with essential hypertension.

Eligibility criteria: Inclusion Criteria:

* 1) Age ≥65 years and ≤85 years, regardless of gender;
* 2) History of essential hypertension and clinical systolic blood pressure ≥ 140 mmHg, regardless of whether they are receiving antihypertensive medication;
* 3) Willing to participate and sign the informed consent.

Exclusion Criteria:

* 1) Secondary hypertension;
* 2) Clinical blood pressure ≥ 180/110 mmHg or 24-hour mean arterial pressure ≥ 170/100 mmHg;
* 3) Severe organ dysfunction or failure;
* 4) Severe hematologic disorders or significant coagulation abnormalities;
* 5) History of atrial fibrillation or myocardial infarction within 6 months;
* 6) Individuals who had contraindication of remote ischemic conditioning, such as severe soft tissue injury, fracture or vascular injury in the upper limb, acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc;
* 7) Individuals who will or have received anticoagulant therapy with drugs such as dabigatran, rivaroxaban, warfarin, etc;
* 8) Those who are participating in other clinical research or has participated in other clinical research or has participated in this study within 3 months prior to enrollment;
* 9) Other conditions that the researchers think are not suitable for the project.

Primary outcomes:
measure: Mean systolic blood pressure
timeFrame: 0-7 days
Secondary outcomes:
measure: Mean diastolic blood pressure
timeFrame: 0-7 days
Other outcomes:
Locations:
city: Changchun
country: China
facility: First Hospital of Jilin University
state: Jilin
Study officials:
References:
Clinical trial NCT03801005: Immunophenotyping of Blast Cells and Immune Effector Cells in Peripheral Whole Blood and Bone Marrow Samples From AML and MDS Patients (AML)
Official title: Immunophenotyping of Blast Cells and Immune Effector Cells in Peripheral Whole Blood and Bone Marrow Samples From AML and MDS Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2019-01-11
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with myelodysplastic syndrome (with excess blasts) or acute myeloid leukemia

Brief summary: The objective of this study is to evaluate the immune profile of blast cells and immune effector cells in paired peripheral whole blood and bone marrow samples from AML and MDS patients by standardized flow cytometry. A special emphasis will be focused on monitoring expression of CD200 as well as PGP-170 (MDR1) on blasts cells.


Eligibility criteria: Inclusion Criteria:

* Age \> 18
* No pregnant woman
* Patient with myelodysplastic syndrome (with excess blasts) or acute myeloid leukemia
* Presence of a monitored serum blastose
* Patient who can obtain free and informed consent (speaks French, no guardianship or curatorship)

Exclusion Criteria:

* Minor Patient (\< 18 years old)
* Medical or psychological Condition that could interact with the ability to understand the study,
* Pregnant or lactating women,
* Major persons under guardianship or under the protection of justice
* Persons deprived of their liberty by a judicial or administrative decision
* Lack of information and opposition to its participation in the study

Primary outcomes:
measure: evaluate the immune profile of blast cells and immune effector cells in paired peripheral whole blood and bone marrow samples from AML and MDS patients by standardized flow cytometry.
timeFrame: 9 mounths
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique - Hopitaux de Marseille
Study officials:
References:
Clinical trial NCT06771505: SBS DISK- Creation of a Quality of Life Tool for Short Bowel Patients Compared with a Validated Quality of Life Questionnaire (SBS QoL)
Official title: SBS DISK- Creation of a Quality of Life Tool for Short Bowel Patients Compared with a Validated Quality of Life Questionnaire (SBS QoL)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Short Bowel Syndrome
Keywords: Short Bowel syndrome
Quality of life
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will focus on adult patients with short bowel syndrome followed up in the GHS Intensive Clinical Nutrition Department, during a consultation, a day hospital or a conventional hospital stay.

Brief summary: Patients with short bowel syndrome have an impact on their quality of life because they need temporary or permanent parenteral nutritional support. The quality of life of these patients has been the subject of several studies and assessment tools exist, such as the Short Bowel Syndrome Quality of Life (SBS QoL). This tool may seem complex and tedious to use in everyday practice. However, it is important to regularly assess the quality of life of these patients. This is why the investigators are proposing to create a new tool for more rapid assessment of the quality of life of patients with short bowel syndrome.


Eligibility criteria: Inclusion Criteria:

* Age 18 or over
* Patient able to read and speak French
* Patient suffering from short bowel syndrome

Exclusion Criteria:

* Known cognitive disorders

Primary outcomes:
measure: Validation of a new quality of life tool, the SBS disk, in comparison with a quality of life assessment tool, the SBS QoL.
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Hôpital Lyon Sud - CHLS
Study officials:
affiliation: Service d'hépato-gastro-entérologie et Assistance nutritionnelle - Hôpital Lyon Sud - CHLS
name: Charlotte BERGOIN, Doctor
role: PRINCIPAL_INVESTIGATOR
References: