louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04389346: A Cone Beam Computed Tomographic Evaluation of Healing of Apicomarginal Defects Using Autologous Platelet Aggregates
Official title: A Cone Beam Computed Tomographic Evaluation of Healing of Apicomarginal Defects Using Autologous Platelet Aggregates : A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Apical Periodontitis
Keywords: Apicomarginal defects
Cone Beam Computed Tomography
Autologous platelet aggregate
Lead sponsor: Postgraduate Institute of Dental Sciences Rohtak
Sponsor class: OTHER
First posted: 2020-05-15
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effect of PRF (platelet rich fibrin) on the healing of apicomarginal defects. Healing of the defects will be assessed 2 dimensionaly by periapical radiograph and 3 dimensionaly using CBCT.

Detailed description: Patients with apicomarginal defects as per the inclusion criteria will be randomly divided into two groups - (1) Test group - The denuded root surface will be covered by PRF (Choukron's method) and (2) Control group -No use of autologous platelet aggregate during periapical surgery. Radiographic and clinical healing will be assessed after 12 months, 2D healing will be assessed by Rud and Molven criteria and 3D healing will be assessed by Modified Penn 3D criteria.The clinical parameters recorded including periodontal pocket depth (PD), clinical attachment level (CAL) and gingival margin position (GMP) will be measured on buccal aspect of the interproximal space and mid buccal aspect of the involved teeth using Williams 'O' periodontal probe.Routine examination procedure will be used to evaluate any evidence of signs and/or symptoms.

Eligibility criteria: Inclusion Criteria:

* A negative response to vitality tests with radiographic evidence of periapical radiolucency with no general medical contraindications for oral surgical procedures.
* Apicomarginal communication having probing depth \> 6mm.
* Patients with no general medical contraindications for oral surgical procedures.
* Recurrent episodes of purulent discharge.
* Failed previous root canal treatment.
* Failed previous surgery with persistent bony lesion.
* Adequate final restoration with no clinical evidence of coronal leakage.

Exclusion Criteria:

* Clinical or radiographic evidence of root fracture.
* Resorptive processes involving more than apical third of the root.
* Any systemic disease contraindicating oral surgery including uncontrolled diabetes and pregnancy.
* Any condition effecting rate of healing like smoking.

Primary outcomes:
measure: Change in periapical radiolucency
timeFrame: Baseline to 12 Months
Secondary outcomes:
measure: Clinical success
timeFrame: Baseline to 12 Months
Other outcomes:
Locations:
city: Rohtak
country: India
facility: Ankita Ramani
state: Haryana
Study officials:
affiliation: POST GRADUATE INSTITUTE OF DENTAL SCIENCES, ROHTAK
name: ANKITA RAMANI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04398069: Hemodynamic Optimisation Guided With Transcranial Doppler in Septic Shock
Official title: Hemodynamic Optimisation Guided With Transcranial Doppler in Septic Shock
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Trans Cranial Doppler Ultrasonography in Heamodynamic Optimisation in Septic Shock
Keywords: Trans cranial doppler ultrasonography, hemodynamics, septic shock, sepsis associated encephalopathy
Lead sponsor: Mongi Slim Hospital
Sponsor class: OTHER
First posted: 2020-05-21
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Randomized, controlled, prospective trial, including ICU patients with Sepsis or septic Shock, at the early phase.

patients will be randomized in 2 groups regarding the hemodynamic management and catecholamin doses:

* Group 1: standard hemodynamic goals and catecholamin infusion to achieve: mean arterial pressure \> or equal to 65 mmHg and diastolic arterial pressure \> ou equal to 50 mmHg within the first 60 minutes.
* Group 2: personalized hemodynamic goals and catecholamin infusion until normal transcranial doppler: IP\<1,2.

Detailed description: Randomized, controlled, prospective trial, including ICU patients with Sepsis or septic Shock, at the early phase.

patients will be randomized in 2 groups regarding the hemodynamic management and catecholamin doses:

* Group 1: standard hemodynamic goals and cathecolamin infusion to achieve: mean arterial pressure \> or equal to 65 mmHg and diastolic arterial pressure \> ou equal to 50 mmHg within the first 60 minutes.
* Group 2: personalized hemodynamic goals and cathecolamin infusion until normal transcranial doppler: IP\<1,2.

For the 2 groups, standard management including: microbiological sampling, early broad spectrum anti infective therapy, fluid management and decreasing of blood lactate levels, will be aimed within the first 60 minutes.

For the Group 2 patients: personalized hemodynamic management will be maintained during 72 hours.

Eligibility criteria: Inclusion Criteria:

* All ICU patients presenting septic shock
* No criteria of traumatic or vascular brain injury

Exclusion Criteria:

* Patients with refractory septick shock
* rapid fatal evolution: before 72 hours
* No individualisation of the MCA ultrasonographic window

Primary outcomes:
measure: mortality at day 28
timeFrame: 28 days after ICU admission
Secondary outcomes:
measure: Incidence of sepsis associated encephalopathy
timeFrame: 28 days after ICU admission
measure: Incidence of sepsis related organ failures
timeFrame: 28 days after ICU admission
measure: Length of ICU stay
timeFrame: 30 days after end of randomization
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Mongi Slim Hospital
Study officials:
affiliation: Mongi Slim Hospital
name: Mhamed Sami Mebazaa, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06894069: Intracanal Dexamethasone Extrusion and Postoperative Endodontic Pain
Official title: Effect of Intentional Extrusion of an Intracanal Corticosteroid Solution on Post Endodontic Treatment Pain: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Post Operative Pain Control
Endodontic Treatment
Keywords: Root canal treatment
Post-operative pain
Corticosteroids
Dexamethasone
Randomised controlled trial
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2025-03-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this research is to assess the effect of intentionally extruding a corticosteroid intracanal solution into the periapical tissues on the postoperative pain after root canal treatment in patients with symptomatic irreversible pulpitis and symptomatic apical periodontitis (SIP/SAP). The main question it aims to answer: Is there an analgesic effect of extruding an intracanal solution of DXA into the periapical tissues in patients diagnosed with SIP/SAP? Researchers will compare dexamethasone to a placebo to see if the extrusion dexamethasone works in reducing post-endodontic treatment pain.


Eligibility criteria: Inclusion Criteria:

* A diagnosis of irreversible pulpits with symptomatic apical periodontitis
* Adult patients (aged 18 - 70)
* Healthy patients or those with a well-controlled disease (ASA I \& II)

Exclusion Criteria:

* A diagnosis of necrotic pulp, or normal apical tissues
* Patients with a severe systemic disease (ASA III or higher)
* Patients who received analgesics12 hours before presentation
* Previously treated/initiated Endodontics treatment on the same tooth
* Unopposed teeth
* Third molar teeth
* Non-restorable teeth
* Periodontally compromised teeth
* Pregnant or lactating patients

Primary outcomes:
measure: Post-operative pain following root canal treatment
timeFrame: at 12, 24, 48 and 72 hours after completing the treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04940169: Anterior Cruciate Ligament Reconstruction Made With Hamstring Tendon And Quadriceps Tendon Autografts
Official title: Prospective Comparison Of Arthroscopic Anterior Cruciate Ligament Reconstrictions Made With Hamstring Tendon And Quadriceps Tendon Autografts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Cruciate Ligament Injuries
Lead sponsor: SB Istanbul Education and Research Hospital
Sponsor class: OTHER
First posted: 2021-06-25
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Anterior cruciate ligament reconstruction (ACLR) is one of the most common procedure all around the world, however optimal graft source for ACLR still remains controversial. Although Quadriceps tendon (QT) is the least used and least studied autograft, it could be an appropriate and good alternative for ACLR. If investigaters use the same surgical technique, and exert the same rehabilitation methods they may have better results than hamstring tendon (HT) autografts.

Detailed description: Investigators enrolled 36 patient and randomized them to different group (HT, QT). at the first evaluation examination findings noted, PROMs (patient reported outcome measurements) questioned, thigh circumference measured, flexor and extensor thigh muscle strength recorded with help of Humac CYBEX Norm (CSMI, 2004) device. After these examinations and preparations all patients operated by the same surgeon who is familiar with both technique. The same surgical technique and fixation method used for both groups. At 1st year follow-up all evaluations PROMs (İKDC,lysholm,VAS) and measurements repeated. Back to the sports rates and postoperative complications compared between HT-QT.

Eligibility criteria: Inclusion Criteria:

diagnosed primary ACL rupture willing to involve study

* lesser than Outerbridge 2 cartilage lesions, non-buckethandle meniscus injuries

Exclusion Criteria:

more than one ligament injury greater than outerbridge 3 cartilage injury buckethandle meniscus injuries re-ruptures bilateral injuries previous knee surgery any disease affecting muscle strength

-

Primary outcomes:
measure: KOOS
timeFrame: Change from Baseline score at one year.
measure: lysholm
timeFrame: Change from Baseline score at one year.
measure: VAS
timeFrame: Change from baseline score at one year.
measure: IKDC
timeFrame: Change from baseline score at one year.
measure: STRENGTH TEST
timeFrame: Change from baseline score at one year.
measure: subjective instability test
timeFrame: Change from baseline score at one year.
measure: thigh circumference
timeFrame: Change from baseline score at one year.
measure: one leg hop test
timeFrame: Change from baseline score at one year.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul education and research hospital
Study officials:
References:
Clinical trial NCT03836469: Retrospective Epidemiological Study of Locally Advanced Non Small Cell Lung Cancer Patients in Brazil
Official title: Retrospective Epidemiological Study of Locally Advanced Non Small Cell Lung Cancer Patients in Brazil
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer, Non-small Cell
Keywords: Lung cancer
Non-small cell
Lead sponsor: Latin American Cooperative Oncology Group
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2019-02-11
Enrollment: 403
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with stage IIIA or IIIB NSCLC in the period of January 2015 to December 2016.

Brief summary: RELANCE is a large multi-institutional study that aims to retrospectively collect information about diagnostic, treatment and outcome of patients diagnosed with locally advanced NSCLC in Brazil. It is hypothesized that there is a great heterogeneity in treatment patterns owing to inequities in access to adequate staging methods, optimal treatment and multidisciplinary teams in Brazil.

Detailed description: RELANCE study will collect sociodemographic and clinical data of patients diagnosed with locally advanced NSCLC in the period of January 2015 and Jun 2019 in the participating institutions. Socio-demographic characteristics, clinicopathological features, treatments patterns and outcomes will be recovered from medical charts. Disease status and survival data will be collected up to the last date of follow-up June 2021.

Eligibility criteria: Inclusion Criteria:

1. Patients aged 18 years or older;
2. Histologically or cytological diagnosis of NSCLC in the period of January 2015 to December 2016;
3. Locally Advanced NSCLC defined as clinical stage IIIA and IIIB according to 7th Edition TNM Staging System;
4. Any NSCLC histological subtype and molecular mutation;
5. Any Eastern Cooperative Oncology Group (ECOG) Performance Status (0 to 4) at diagnosis;
6. Patients assigned by treating physician to any therapy or palliative care;
7. Access to patient medical chart for data collection.

Exclusion Criteria:

1. Small cell lung cancer and non-invasive NSCLC;
2. Synchronic NSCLC or second primary tumour in the last 5 years (except non-melanoma skin cancer).

Primary outcomes:
measure: Overall survival
timeFrame: Up to June 30, 2018
Secondary outcomes:
measure: Progression free survival
timeFrame: Up to June 30, 2018
measure: Time to next treatment
timeFrame: Up to June 30, 2018
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: AC Camargo
state: SP
Study officials:
affiliation: Latin American Cooperative Oncology Group
name: Vladmir Cláudio Cordeiro de Lima
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06519669: Autologous Tumor-Infiltrating Lymphocyte Injection(GT201) for Treatment of Patients with Advanced Lung Cancer
Official title: A Single-arm Clinical Study of Autologous Tumor-Infiltrating Lymphocyte (GT201 Injection ) for Treatment of Patients with Advanced Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adult
Lung Cancer
Lead sponsor: Grit Biotechnology
Sponsor class: INDUSTRY
First posted: 2024-07-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a single arm, open design aimed at evaluating the safety and tolerability of Autologous Tumor-Infiltrating Lymphocyte (GT201 injection ) for treatment of patients with Advanced lung cancer,while evaluating pharmacokinetic characteristics and efficacy assessment.


Eligibility criteria: Inclusion Criteria:

* 1. Voluntarily join the study, signed informed consent form，willing and able to comply with the study protocol;
* 2. Age 18 to 70 years old;
* 3. Queue 1: Late stage non-small cell lung cancer without driver genes that have failed first-line systemic treatment;Queue 2: Small cell lung cancer with first-line systemic treatment failure;
* 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
* 5. Expected survival time of ≥ 12 weeks;
* 6. Good function of vital organs;
* 7. Subjects entering this study due to disease progression must have an imaging record of disease progression before tumor sampling;
* 8. At least one measurable target lesion that meets the definition of RECIST v1.1 after tumor sampling.

Exclusion Criteria:

* 1.Patients with uncontrollable tumor-related pain as judged by the investigator; participants requiring analgesic medication must already have a stable analgesic regimen at the time of study entry; symptomatic lesions suitable for palliative radiotherapy should be completed prior to study entry;
* 2.Known mental illness, alcoholism, drug use or substance abuse;
* 3.Pregnant or lactating women; or women who are pregnant, breastfeeding, or planning to become pregnant within 1 year after cell infusion;
* 4.Those who have received other clinical trial drug treatment within 4 weeks before preconditioning by lymphodepletion,plan to participate in other clinical trial drug treatment during the study;
* 5.The investigators determine that other conditions that make the patient not suitable for enrollment.

Primary outcomes:
measure: Objective response rate
timeFrame: 3 years
measure: Incidence and severity of adcersed events per CTCAE 5.0
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing GoBroad Hospital
state: Beijing
city: Shanghai
country: China
facility: Renji Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
References:
Clinical trial NCT06098469: Developping a a Brain-controlled Art App to Ease Residual Symptoms of Depression
Official title: Developping a a Brain-controlled Art App to Ease Residual Symptoms of Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2023-10-24
Enrollment: 22
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study evaluate the effect of 10 neurofeedback sessions on the residual symptoms of depressive patients in partial remission.


Eligibility criteria: Inclusion Criteria:

* Subjects aged 25 to 65 included
* Information and signed informed consent
* Patients with a diagnosis of major depressive episode in remission
* MADRS score between 14 and 22
* Patients with residual symptoms as assessed by MADRS items
* No cognitive impairment.
* Right-handed

Exclusion Criteria:

* Subjects with legal incapacity or limited legal capacity
* Subjects unlikely to cooperate with the study and/or poor cooperation anticipated by the investigator
* Pregnant women
* Subjects in the exclusion period of another study or is on the "national volunteer list".
* Subjects with another psychiatric pathology (bipolar mood disorder, psychosis, obsessive-compulsive disorder, addictive pathology, schizophrenia)
* Subjects under a protective measure such as guardianship or safeguard of justice.

Primary outcomes:
measure: Evaluate the effect of 10 neurofeedback sessions on residual symptoms in depressive patients in partial remission
timeFrame: Week 10
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU Besançon
Study officials:
affiliation: CHU de Besançon
name: Emmanuel HAFFEN, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04984369: The Efficacy of HLX208 (BRAF V600E Inhibitor) With Cetuximab for Metastatic Colorectal Cancer (mCRC) With BRAF V600E Mutation After First-line Treatment
Official title: An Open, Multicenter Phase II Clinical Study to Evaluate Safety and Efficacy of HLX208 (BRAF V600E Inhibitor) Combined With Cetuximab in Patients With Metastatic Colorectal Cancer (mCRC)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: CRC
Lead sponsor: Shanghai Henlius Biotech
Sponsor class: INDUSTRY
First posted: 2021-07-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An open, multicenter phase II clinical study to evaluate safety and efficacy of HLX208 (BRAF V600E inhibitor) combined with cetuximab for metastatic colorectal cancer (mCRC) with BRAF V600E Mutation after first-line treatment


Eligibility criteria: Inclusion Criteria:

* Age\>=18Y
* Good Organ Function
* Expected survival time ≥ 3 months
* Metastatic/recurrent advanced BRAF+ mCRC that have been diagnosed histologically and have failed first line treatment
* ECOG score 0-1;

Exclusion Criteria:

* arm 1 ： Previous treatment with BRAF inhibitors or MEK inhibitors
* Symptomatic brain or meningeal metastases (unless the patient has been on \> treatment for 3 months, has no evidence of progress on imaging within 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable).
* Active clinical severe infection;
* A history of other malignancies within two years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin.

Primary outcomes:
measure: ORR
timeFrame: up to 2 years
Secondary outcomes:
measure: PFS
timeFrame: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years]
measure: OS
timeFrame: from the date of first dose until the date of death from any cause，assessed up to 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Affiliated Oncology Hospital
Study officials:
References:
Clinical trial NCT02901769: Emotional Prosody Recognition and Decision Making Inf fMRI and Vulnerability to Suicide
Official title: Emotional Prosody Recognition and Decision Making Inf fMRI and Vulnerability to Suicide
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Suicide
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2016-09-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Suicide is known to be frequent in depression, and in most of the psychiatric diseases. But as it can occur in patients with no psychiatric illness and doesn't occur in every patients with psychiatric illness, it has to be considered henceforth as a specific vulnerability.

This trial will study two fMRI paradigms, emotional prosody recognition and decision making, in order to characterize emotional and cognitive trait factors in a population of patients vulnerable to suicide. Four different groups will be constituted : depressed suicide attempters, depressed patients with past history of suicidal acts, depressed patients with no history of suicidal acts and healthy controls.

The main goal will be to correlate fMRI activation during the two paradigms in subjects vulnerable to suicide. The secondary goals will be to characterize emotional and cognitive trait factors in these subjects, to demonstrate that those characteristics are independent from depression and to correlate these trait factors with socio-demographic and clinical features with fMRI activations.


Eligibility criteria: Inclusion Criteria:

* Right-handed,
* Depressed suicide attempters for the first group,
* Depressed patients with past history of suicidal acts for the second group,
* Depressed patients with no history of suicidal acts for the third group,
* Healthy controls for the fourth group.

Exclusion Criteria:

* Another psychiatric trouble than depression,
* Another psychotrope treatment than SSRI/SNRI and/or benzodiazepine at inclusion and/or one month before,
* For the first and secand groups : more than fous suicidals acts within the past 3 years,
* Deficits that do not allow test realisation (visual audition troubles, cognitif deficits,
* Prosopagnosia,
* Pregnancy,
* Severe central nervous system disease or somatic disease,
* MRI contra-indication,
* Major benefiting from a legal protective measure,
* No coverage care.

Primary outcomes:
measure: fMRI activation area
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: Rennes university hospital
Study officials:
References: