louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04263805: A Vignette-based Randomized Controlled Trial to Evaluate the Impact of Research Climate on Research Practices of Doctoral Students
Official title: A Vignette-based Randomized Controlled Trial to Evaluate the Impact of Research Climate on Research Practices of Doctoral Students Facing Dilemma Situations
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: The Study Focus on no Specific Condition
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-02-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aims to evaluate the impact of research climate on PhD students' research practice (i.e., an environment where their peer (i.e., a post-doc researcher) had detrimental practice in a similar situation)

Detailed description: PhD students are the next generation of researchers and will present the field in the future. However, several environmental factors might influence their research practice. In this study, the investigators will evaluate the impact of research climate on PhD students' research practice (exposure to an environment where their peers commit a detrimental practice).

Objective: To evaluate the impact of research climate on PhD students' research practice

Design: A randomized controlled trial

1. Intervention: Participants will be shown two case vignettes describing dilemma situations in research reported with and without research climate factor.
2. Participants: The participants will be PhD students in all biomedical disciplines.
3. Sample size will be 300 participants
4. Primary outcome: In each vignette, participants will have to indicate which solution they prefer on a semantic differential scale, rated from - 5 to -1 (preference for solution A) and from 1 to 5 (preference for solution B). Participants will be forced to make a choice between the 2 solutions. The primary outcome will be the mean preference score.
5. This study is approved by ethics review regulations by INSERM (CEEI-IRB): IRB00003888

Eligibility criteria: Inclusion Criteria:

* PhD students in biomedical disciplines

Exclusion Criteria:

* NA

Primary outcomes:
measure: mean preference score
timeFrame: Immediate assessment
Secondary outcomes:
measure: proportion of students who chose the detrimental research practice (DRP)
timeFrame: Immediate assessment
Other outcomes:
Locations:
city: Paris Cedex 04
country: France
facility: Centre d'Epidémiologie Clinique, hôpital Hôtel Dieu, Assistance Publique-Hôpitaux de Paris
Study officials:
References:
Clinical trial NCT06909305: Effect of Intraarticular Ozone, Prolotherapy or Dexmedetomidine in Pain Limitation in Knee Osteoarthritis
Official title: Effect of Intraarticular Ozone, Prolotherapy or Dexmedetomidine in Pain Limitation in Knee Osteoarthritis: A Randomized Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraarticular
Ozone
Prolotherapy
Dexmedetomidine
Pain
Knee Osteoarthritis
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-04-03
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to compare intraarticular ozone injection, prolotherapy, or dexmedetomidine effectiveness in knee osteoarthritis patients.

Detailed description: Osteoarthritis (OA) is a heterogeneous group of disorders of different etiologies with similar biological, morphological, and clinical manifestations and outcomes. The intraarticular injection has been recommended to alleviate the pain in the knee joint.

Ozone therapy has long been used in the management of OA. Furthermore, it has been shown to not cause a significant inflammation process or cartilage degradation. Prolotherapy is a procedure where a natural irritant is injected into the soft tissue of an injured joint. Dexmedetomidine is a selective α2-adrenergic agonist with considerable sedative and analgesic actions.

Eligibility criteria: Inclusion Criteria:

* Age from 30 to 65 years.
* Both genders.
* Patients diagnosed with stage 1-3 osteoarthritis according to the Kellgren-Lawrence Classification System (K-L).

Exclusion Criteria:

* Patient refusal.
* History of knee trauma within the past month.
* Rheumatic disease.
* Pregnancy.
* Any surgical intervention of the knee.
* Severe cardiovascular disease.
* Morbid obese patients (body mass index (BMI) of \>35 kg/m2).
* Local infection at the site of injection.
* Bleeding diathesis.

Primary outcomes:
measure: Analgesic requirement
timeFrame: 3 months after the procedure
Secondary outcomes:
measure: Improvement of lifestyle
timeFrame: 3 months after the procedure
measure: Improvement of knee joint cartilage regeneration
timeFrame: 3 months after the procedure
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References:
Clinical trial NCT05440305: Unicentric Form of Castleman Disease - Surgery Therapy Benefit
Official title: Castleman Disease - Diagnosis and Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Castleman Disease
Unicentric Castleman Disease
Surgery
Keywords: Unicentric form of Castleman disease
Surgical resection
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2022-06-30
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Group of patients with unicentric form of Castleman disease

Brief summary: Observation study on patients with unicentric form of Castleman disease, evaluation of surgical treatment benefit. Observation of surgical treatment strategy.


Eligibility criteria: Inclusion Criteria:

* patient with unicentric form of Castleman disease
* underwent surgery resection

Exclusion Criteria:

* multilocalised Castleman disease

Primary outcomes:
measure: 5 year survival
timeFrame: each 6 months checkup, up to 150 weeks, from date of randomization until the date of first documented progression
measure: recurence rate
timeFrame: each 6 months checkup, up to 150 weeks, from date of randomization until the date of first documented progression
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05810805: Measurement and Analysis of Gas Composition in Digestive Tract
Official title: Measurement and Analysis of Gas Composition in Digestive Tract: a Prospective, Single-center Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inflammatory Bowel Diseases
Irritable Bowel Syndrome
Functional Dyspepsia
Colorectal Neoplasms
Helicobacter Pylori Infection
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing endoscopy at Qilu Hospital of Shandong University

Brief summary: The purpose of this study is to detect the concentration of various gases，including hydrogen, methane, hydrogen sulfide, nitric oxide in different parts of the digestive tract by a safe and direct method, and to establish a human digestive tract gas profiles. Analyze the differences in gas components in different segments of the digestive tract in patients with different diseases, and analyze the correlation between specific gases and digestive tract diseases and non-specific symptoms.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 to 70 years.
* Patients undergoing endoscopic examination

Exclusion Criteria:

* Patients with serious underlying diseases, such as liver insufficiency, renal insufficiency, immunosuppression, coronary heart disease (angina pectoris or coronary artery stenosis ≥ 75%).
* Patients have history of gastrointestinal surgery
* Patients who failed to complete the endoscopic examination due to various reasons
* Patients Boston score of Bowel preparation≤ 6 points
* Patients who have medication history of probiotics, antibiotics, PPIs and prokinetic drugs in the last 4 weeks
* Patients who combined with thyroid disease and other diseases that affect gastrointestinal motility
* Patients who combined with other risk factors such as mental illness, alcoholism, and drug abuse
* Patients who unable or unwilling to provide informed consent

Primary outcomes:
measure: Concentrations of different gas in digestive tract
timeFrame: immediately after the procedure
Secondary outcomes:
measure: Correlation between digestive tract and breath test
timeFrame: Immediately after the procedure
measure: Differences in concentrations of H2, CH4, NO, and H2S in the digestive tract between patients with different gastrointestinal diseases and normal individuals.
timeFrame: Immediately after the procedure
measure: The correlation between the severity of gastrointestinal symptoms and gas concentrations in various parts of the digestive tract.
timeFrame: Immediately after the procedure
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital, Shandong University
state: Shandong
Study officials:
References:
Clinical trial NCT04499105: Effectiveness and Safety of Mesenchymal Stem Cell (MSC) Implantation on Degenerative Discus Disease Patients
Official title: Effectiveness and Safety of Allogenic Mesenchymal Stem Cell (MSC) Implantation on Degenerative Discus Disease Patients (Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Degenerative Disc Disease
Low Back Pain
Disc Degeneration
Keywords: DDD
MSC
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates the effectivity and safety of MSC implantation on Degenerative Disc Disease Patients by assessing visual analog scale, ROM improvement and MRI examination.

Detailed description: The team plan to conduct research to look at the effectiveness and safety of mesenchymal stem cell implantation therapy in intervertebral disc degeneration patients.

The use of allogenic mesenchymal stem cells from the umbilical cord was chosen because patients with degeneration of the intervertebral disc are elderly (over 50 years old) so that autologous mesenchymal stem cell administration is not possible in terms of taking the source of cells (bone marrow) nor the quality of mesenchymal stem cells obtained.

This study will assess the improvement of clinical symptoms (VAS to assess pain scale, ASIA and Frankel scale, as well as assessment of the widening of the lumbar region using the Schober Test), changes in the structure of the intervertebral discs (through MRI examination and grading the degree of intervertebral disc degeneration), conduction function spinal cord nerve (somatosensory evoked potential / SSEP), myelography / EMG, and assessment of the quality of life status of patients using the Oswestry Disability Index.

Eligibility criteria: Inclusion Criteria:

1. Patients enrolled in Cipto Mangunkusumo Hospital with degenerative disc disease with no promising result after conventional treatment.
2. No history of metabolic, autoimun and genetic disease(s).
3. No active infection (HbsAg, HIV, CMV, Rubella).
4. Agree to participate the study by signing informed consent form.

Exclusion Criteria:

1. Patients under 20 years old.
2. Declined to participate in the study.

Primary outcomes:
measure: Improvement of Low Back Pain
timeFrame: 6 months
measure: Tissue Improvement
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo Hospital
state: DKI Jakarta
Study officials:
References:
Clinical trial NCT06640205: Assessment of I-PRF Versus Nano MTA Combined with I-PRF Scaffold in Vital Pulp Therapy in Mature Mandibular First Molars
Official title: Clinical and Radiographic Assessment of I-PRF Versus Nano Mineral Trioxide Aggregate Combined with I-PRF Scaffold in Vital Pulp Therapy in Mandibular First Molars with Closed Apices: "Randomized Controlled Trial"
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulpotomy
Lead sponsor: Future University in Egypt
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 51
Sex: ALL
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Assessment of I-PRF versus Nano Mineral trioxide aggregate Combined with I-PRF in pulpotomy in mature Mandibular First Molars

Detailed description: Clinical and Radiographic Assessment of I-PRF versus Nano Mineral trioxide aggregate Combined with I-PRF Scaffold in Vital Pulp Therapy in Mandibular First Molars with Closed Apices: "Randomized Controlled Trial"

Eligibility criteria: Inclusion Criteria:

* Patients suffering from Symptomatic irreversible pulpitis in mature mandibular molars only will be involved.

  * Patients of either gender aged from 15-30.
  * Tooth should give positive response to cold test.
  * The tooth is restorable
  * Patients should be free from any systemic disease that may affect normal healing and predictable outcome.
  * Patients who will agree to the consent and will commit to follow-up period.
  * Patients with mature root.
  * Patients with no internal or external resorption and no periapical lesions.
  * Soft tissues around the tooth are normal with no swelling or sinus tract.

Exclusion Criteria:

* Patients with immature roots.

  * Haemostasias after 10 minutes can not be controlled after total pulpotomy
  * Patients with periapical lesions or infections.
  * Pregnant females.
  * Patients with fistula or swelling
  * Patients with necrotic pulp.

Primary outcomes:
measure: Post operative pain assessments
timeFrame: 6 hours post operative , 12 hours post operative , 24h (one day) post operative , 72h (3 days ) post operative and 7 days (one week) post operative
Secondary outcomes:
measure: Clinical and radiographic success
timeFrame: 1 month post operative ,3 months clinical and radiograph ,6 months clinical and radiograph ,9 months clinical and radiograph and 12 months clinical and radiograph.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Future university in egypt
Study officials:
affiliation: Future University in Egypt
name: Abdelrahman Mo Omar, Master
role: STUDY_CHAIR
References:
Clinical trial NCT02122705: A Case Series of VPIA Using Remifentanil for Labour and Delivery
Official title: A Case Series of Vital Signs-controlled, Patient Assisted Intravenous Analgesia (VPIA) Using Remifentanil for Labour and Delivery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Labor Pain
Keywords: Remifentanil
Labour analgesia
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
First posted: 2014-04-24
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Term parturients presenting to the hospital delivery suite in labour

Brief summary: This study is a prospective case series aiming to evaluate a new VPIA remifentanil algorithm which would benefit labouring mothers who are unable or unwilling to receive epidural analgesia.

Detailed description: This study proposes a novel Vital signs-controlled, patient-assisted intravenous analgesia (VPIA) regimen that will enhance the efficacy, safety and personalization of remifentanil therapy for labouring women. This system will study the parturient's pattern of analgesic use in 15 min epochs and titrate the demand doses and basal infusion rate to maintain a plasma level of remifentanil that is appropriate for the degree of pain felt.

The system incorporates vital signs (pulse oximetry and heart rate values) into the algorithm which would temporarily stop the pumps and step down doses accordingly when predefined critical values are reached.

Eligibility criteria: Inclusion Criteria:

* Patients who choose to use parenteral opioid for pain relief with informed consent
* Patients who refuse labour epidural analgesia
* Patients with contraindication to epidural analgesia (eg. Thrombocytopaenia, previous thoraco-lumbar spinal instrumentation)

Exclusion Criteria:

* Patients who are unable to understand instructions given regarding the use of patient controlled analgesia (PCA) or unable to self administer PCA boluses
* Patients with difficulty in communication due to language differences
* Patients with known hypersensitivity to remifentanil or any component of its formulation or to other fentanyl analogs
* Patients with severe respiratory disease
* Patients with history of drug dependence of recreational drug abuse
* Patients with unmanaged foetal bradycardia

Primary outcomes:
measure: Pain score
timeFrame: Duration of labour
Secondary outcomes:
measure: Remifentanil drug consumption
timeFrame: Duration of labour
measure: Maternal side effects
timeFrame: Duration of labour and 1st day post delivery
measure: Maternal outcomes
timeFrame: Duration of labour and one day post delivery
Other outcomes:
measure: Neonatal outcomes
timeFrame: Duration of labour and one day post delivery
Locations:
city: Singapore
country: Singapore
facility: KK Women's & Children's Hospital
Study officials:
affiliation: KK Women's & Children's Hospital
name: Wan Ling Leong, MBBS FANZCA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06206005: Four Mandibular Implant-retained Overdentures in Individuals With Type 2 Diabetes
Official title: Clinical and Radiographic Outcomes Around Four Mandibular Implant-retained Overdentures in Individuals With Type 2 Diabetes: A Long-term Retrospective Preliminary Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bone Resorption
Lead sponsor: Mansoura University
Sponsor class: OTHER
Collaborators: name: Menoufia University
First posted: 2024-01-16
Enrollment: 20
Sex: ALL
Minimum age (years): 55
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 20 participants at least.

Brief summary: Studies clinically evaluate the long-term outcome of 4 implant attachment-retained mandibular OVDs among patients with high glycemic levels are lacking.

Detailed description: Chronic hyperglycemia is considered as a typical risk-factor that causes soft tissue inflammation and bone loss around natural teeth and implants. One possible explanation for this mechanism is that chronic hyperglycemia has the propensity to increase the levels of accumulated glycation end products (AGEs) in the serum and oral tissues that accelerates the production of proinflammatory cytokines that induce bone destruction around natural teeth and implants. However, it is relevant to indicate that dental implants in chronic hyperglycemia under ideal glycemic conditions can successfully osseointegrate and show predictable outcomes over long durations in both diabetic and non-diabetic patients.

Studies clinically evaluate the long-term outcome of 4 implant attachment-retained mandibular OVDs among patients with high glycemic levels are lacking.

Eligibility criteria: Inclusion Criteria:

* Patients with edentulous maxilla and mandible for at least 12 months.
* Patients have problems with mandibular denture retention and stability.
* Patients with a mandibular bone height measured on a panoramic x-ray between 15 and 25 mm at the mandibular symphysis region.

Exclusion Criteria:

* Patients who did not receive implants at the department clinic.
* Patients with more or less than 4 implants in the mandible.
* Patients with well controlled diabetics.
* Patients with relative contraindications, such as a history of parafunctional habits, daily smokers of more than 10 cigarettes, or alcoholism.
* Patients who have previously received head and neck radiation therapy; furthermore, patients receiving intravenous bisphosphonates, chemotherapy, or psychological disorders could jeopardize their cooperation.

Primary outcomes:
measure: Crestal bone loss around implants
timeFrame: This is a retrospective study, Measurement will be performed after implants being in service by 10 years
Secondary outcomes:
measure: Probing depth
timeFrame: This is a retrospective study, Measurement will be performed after implants being in service by 10 years
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mohammed ELSawy
Study officials:
References: