louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03014388: Posterior Maxillary Ridge Augmentation With Sinus Lift Using Mineralized Plasmatic Matrix Versus Autogenous Bone Graft
Official title: Posterior Maxillary Ridge Augmentation With Sinus Lift Using Mineralized Plasmatic Matrix Versus Autogenous Bone Graft (A Randomized Clinical Trial Comparative Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bone Resorption
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-01-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Using growth factors obtained from patient's venous blood mixed with particulate autogenous bone the study compares bone gain by implant with gold standards in sinus Lift procedures for future implant insertion.

Detailed description: To study the effectiveness of MPM in ridge augmentation with implant insertion compared with autogenous bone graft.

-PICO Population(P) : Patients with defective posterior maxillary alveolar ridge. Intervention (I) :Implant placement and ridge augmentation with MPM. Comparator (C) : Autogenous bone graft. Outcome (O) : Patient satisfaction - Implant stability.

Eligibility criteria: Inclusion Criteria:

1. Patients systemically free.
2. Patients with posterior maxillary defective ridges indicated for sinus lift procedure.
3. Cases with 5 mm bone height or less are included in the study.
4. Age between 18 and 50 years.
5. Both sexes.
6. Patients physically able to tolerate surgical and restorative procedures.
7. Good oral hygiene.
8. Highly motivated patients.

Exclusion Criteria:

1. Patients allergic to local anesthetic agent.
2. Medium and heavy smokers.
3. Pregnant females.
4. Presence of any pathosis in the pre-implant site.
5. Presence of any mucosal disease.
6. History of oral radiotherapy.
7. History of prolonged steroids use.
8. Psychological disorders.

Primary outcomes:
measure: Patient Satisfaction regarding aesthetic results will be measured using questionnaire.
timeFrame: 9 months
Secondary outcomes:
measure: Stability of dental implants.
timeFrame: 5 months
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University - Ethics Committee.
name: Cairo University CBE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04635488: Prediction Model for Lateral Lymph Node Metastasis
Official title: Radiomics-based Prediction Model for Lateral Lymph Node Metastasis in Rectal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rectal Cancer
Keywords: rectal cancer
lymph node metastasis
prediction model
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with rectal cancer.

Brief summary: Mid to low-lying rectal cancer patient with enlarged lateral lymph node befor treatment and receiving lateral lymph node dissection would be enrolled. Radiomics parameters of lateral lymph nodes would be extracted by expert software. Then a part of the nodes would be used as the training set to build the prediction model, and the another part nodes would be used as the validation set.

Detailed description: After performing lateral lymph node dissection for the enrolled patients, we would find the targeted lateral node which was matched with the enlarged one in imaging from the specimen. Then the nodes would be send for pathological examination. Then we would extract the radiomics parameters of the nodes from the pretreatment CT and MRI with ITK-SNAP software. According to the pathological status, lymph nodes and corresponding radiomics parameters would be divided into positive and negative groups. Then significant parameters would be selected by R software. Then the prediction model with nomogram would be developed. 70% nodes would be used for for model development and the other 30% would be used for validation.

Eligibility criteria: Inclusion Criteria:

* middle to low-lying rectal adenocarcinoma patients with enlarged lateral lymph node ≥5mm for short diameter in CT and/or MRI

Exclusion Criteria:

* other kind of rectal tumor including neuroendocrine and malignant.
* high location rectal cancer.
* recurrent rectal cancer

Primary outcomes:
measure: metastasis rate of lateral lymph node
timeFrame: 2020.1-2022.12.31
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Guoxue Road 37#,West China Hospital
state: Sichuan
Study officials:
References:
Clinical trial NCT04855188: Effectiveness and Safety of YVOIRE Y-Solution 540
Official title: A Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Design Investigation to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 540 Versus YVOIRE Volume Plus in Nasolabial Folds Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wrinkles in the Nasolabial Folds
Lead sponsor: LG Chem
Sponsor class: INDUSTRY
First posted: 2021-04-22
Enrollment: 394
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 540 versus YVOIRE volume plus in Nasolabial Folds Injection


Eligibility criteria: Inclusion Criteria:

* 3 (moderate) or 4 (severe) on the 5-graded WSRS
* who sign the written informed consent form

Exclusion Criteria:

* who have received permanent facial implants
* who have received semi-permanent fillers
* who have undergone temporary dermal filler treatment within 12 months
* who have undergone facial tissue augmentation with fat injections, botulinum toxin injections, mesotherapy, or cosmetic procedures within 6 months
* who have a history of anaphylaxis or allergy to lidocaine, hyaluronic acid (HA) products, or streptococcal protein

Primary outcomes:
measure: WSRS responder rate
timeFrame: 24 weeks after the last injection
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Study officials:
References:
Clinical trial NCT03651388: Research Into the Molecular Bases of a New Phenotype Combining Premature White Hair, Polycystic Kidney Disease, Aortic Dilation/Dissection and Lymphopenia
Official title: Research Into the Molecular Bases of a New Phenotype Combining Premature White Hair, Polycystic Kidney Disease, Aortic Dilation/Dissection and Lymphopenia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: New Phenotype (Combining Premature White Hair, Polycystic Kidney Disease, Aortic Dilation/Dissection and Lymphopenia)
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2018-08-29
Enrollment: 4
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patient

Brief summary: This study involves a single family, including 1 patient, father, mother and sister. The patient presented with a new phenotype associating premature white hair, renal polycystosis, aortic dilation/dissection and lymphopenia. Samples were taken in order to identify the origin of the symptomatology highlighted in the index case.

In addition, it was observed that mice invalidated for bcl-2, normal at birth and indistinguishable from control mice, showed, after one week, a phenotype similar to that observed in this patient.

The overlap between the patient's main clinical signs (lymphopenia, white hair and polycystic renal disease) and the manifestations presented by the invalidated murine model for BCL2 suggests that its phenotype may be secondary to a Bcl-2 expression defect.


Eligibility criteria: This study involves a single family, including 1 patient, father, mother and sister.

Primary outcomes:
measure: Whole genome sequencing of BCL2
timeFrame: Through study completion, an average of 2 years.
measure: Bcl-2-regulating miRNA sequencing
timeFrame: Through study completion, an average of 2 years.
measure: Study of the methylation of the BCL2 promoter
timeFrame: Through study completion, an average of 2 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourogne
Study officials:
References:
Clinical trial NCT00840788: Comparison of Adhesive Glue With Skin Suture for Repair of Episiotomy
Official title: Skin Adhesive Versus Subcuticular Suture for Perineal Skin Repair After Episiotomy - a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mediolateral Episiotomy After Delivery
Keywords: skin adhesive
tissue adhesive
mediolateral episiotomy
perineal repair
labor and delivery
repair
Lead sponsor: Hospital Sao Joao
Sponsor class: OTHER
Collaborators: name: Universidade do Porto
First posted: 2009-02-10
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Surgical repair of perineal lesions after delivery is frequently associated with pain and discomfort interfering with the normal activities of the puerperium. The aim of this study was to compare perineal skin repair after episiotomy with adhesive glue versus a subcuticular suture, regarding the incidence of pain and wound complications.


Eligibility criteria: Inclusion Criteria:

* vaginal delivery
* episiotomy performed
* no further perineal or vaginal lesions present

Exclusion Criteria:

* previously existing local infections or lesions
* body mass index \> 35 (Kg/m2)
* severe pulmonary disease
* collagen disease
* known immunodeficiency
* diabetes mellitus
* immunosuppressive treatment

Primary outcomes:
measure: Self-assessed perineal pain
timeFrame: First 30 days after delivery
Secondary outcomes:
measure: Total time spent with repair of episiotomy
timeFrame: within 1 hour after birth
measure: Pain during procedure
timeFrame: within 1 hour after birth
measure: Difficulties reported during procedure
timeFrame: within 1 hour after birth
measure: Number of sutures and adhesive devices used
timeFrame: within 1 hour after birth
measure: Wound complications
timeFrame: 42-68 hours after delivery
measure: Need to seek health facilities
timeFrame: 30 days after delivery
measure: Return of sexual activity
timeFrame: 30 days after delivery
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Servico de Ginecologia e Obstetricia, Hospital de S, Joao
Study officials:
affiliation: Hospital de S. Joao, Faculdade de Medicina da Universidade do Porto
name: Diogo Ayres-de-Campos, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06142188: Relmacabtagene Autoleucel in Hematologic Malignancies
Official title: A Real-world Study for the Treatment of Hematologic Malignancies With Relmacabtagene Autoleucel
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Lymphoma, B-Cell
Large B-cell Lymphoma
Follicular Lymphoma
Keywords: Relmacabtagene Autoleucel
Chimeric antigen receptor T cells
Lead sponsor: Shanghai Ming Ju Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-11-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hematologic Malignancies

Brief summary: To evaluate the efficacy and safety of Relmacabtagene Autoleucel in the treatment of adult patients with hematologic malignancies in real-world

Detailed description: The purpose of this study is to observationally evaluate the efficacy and safety data of Relmacabtagene Autoleucel for the treatment of patients with hematologic malignancies for up to 15 years after infusion. The treating physician will determine the most appropriate diagnostic and therapeutic regimen for the patient based on clinical practice. No therapeutic intervention will be administered to patients in this study.

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent
2. Patients who have been treated with Relma-cel, including those who have received off-label products;
3. If previously enrolled in another clinical study, they must have completed follow-up in the previous study, or have withdrawn or lost follow-up in the previous study.

Exclusion Criteria:

1.Patients who have been treated with Relma-cel and then have been treated with other CAR-T products.

Primary outcomes:
measure: ORR
timeFrame: 15 years
Secondary outcomes:
measure: CRR
timeFrame: 15 years
measure: Duration of response (DOR)
timeFrame: 15 years
measure: Progression-Free Survival (PFS)
timeFrame: 15 years
measure: Overall Survival (OS)
timeFrame: 15 years
measure: Adverse events (AEs)
timeFrame: 15 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University International Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT01429688: Pharmacokinetic / Pharmacodynamic (PK/PD) Study of Multiple Doses of DP-R202 in Healthy Volunteers
Official title: A Randomized, Single-dose, 2-sequence, 2-period Crossover Study to Investigate the Food-effect Pharmacokinetics of Sarpogrelate HCl Controlled Release Tablet in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Alvogen Korea
Sponsor class: INDUSTRY
First posted: 2011-09-07
Enrollment: 36
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is compare the safety and pharmacokinetic characteristics of DP-R202 (Sarpogrelate HCl 100mg, qd) with those of Anplag (Sarpogrelate HCl 100mg, tid) after multiple oral administration in healthy male volunteers.

Detailed description: The number of patient is thirthy-six.Patients were randomly assigned either anplag tablet(Sarpogrelate HCL 100mg, tid)3days first, DP-R202(Sarpogrelate HCL 300mg, qd) 3days Second or DP-R202(Sarpogrelate HCL 300mg, qd)3days first, anplag tablet(Sarpogrelate HCL 100mg, tid) 3days second.

Eligibility criteria: Inclusion Criteria:

* 20 to 55 years of healthy volunteers

Exclusion Criteria:

* Hypersensitivity Reaction about Sarpogrelate HCL or other antiplatelets

Primary outcomes:
measure: Composite of pharmacokinetics
timeFrame: comparator 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 6.33, 6.67, 7, 7.5, 8, 9, 12, 12.33, 12.67, 13, 13.5, 14, 15, 16, 24h Test drug : 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24h
Secondary outcomes:
measure: Composite of pharmacokinetics
timeFrame: comparator 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 6.33, 6.67, 7, 7.5, 8, 9, 12, 12.33, 12.67, 13, 13.5, 14, 15, 16, 24h Test drug : 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24h
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Jae Wook Ko, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06243588: Identification of Prognostic Factors and Role of Radiotherapy in Patients With Ewing Sarcoma
Official title: Identification of Prognostic Factors and Role of Radiotherapy in Patients With Ewing Sarcoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ewing Sarcoma
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 400
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female patients treated at Rizzoli Orthopaedic Institute between 01/01/1991 and 31/12/2021

Brief summary: assess whether there is a correlation between some factors (age, sex, tumor volume, tumor site, chemotherapy-induced necrosis, radiation and biomarkers) and overall survival (OS) and relapse-free survival (RFS) in patients with Ewing sarcoma.

Identification of reliable prognostic factors could help to identify high-risk patients, which may require a different treatment and follow up.


Eligibility criteria: Inclusion Criteria:

* Male and female patients treated at Rizzoli Orthopaedic Institute between 01/01/1991 and 31/12/2021
* Age ≥ 2 years
* Diagnosis of Ewing Sarcoma
* Patients with available clinical and imaging data

Exclusion Criteria:

* At least one inclusion criterion not met

Primary outcomes:
measure: Correlation
timeFrame: At baseline (Day 0)
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Itituto Ortopedico Rizzoli
state: BO
Study officials:
References:
citation: Grunewald TGP, Cidre-Aranaz F, Surdez D, Tomazou EM, de Alava E, Kovar H, Sorensen PH, Delattre O, Dirksen U. Ewing sarcoma. Nat Rev Dis Primers. 2018 Jul 5;4(1):5. doi: 10.1038/s41572-018-0003-x.
citation: Pressman BD, Tourje EJ, Thompson JR. An early CT sign of ischemic infarction: increased density in a cerebral artery. AJR Am J Roentgenol. 1987 Sep;149(3):583-6. doi: 10.2214/ajr.149.3.583.
Clinical trial NCT05108688: Mirtazapine vs Sumatriptan in the Treatment of Postdural Puncture Headache
Official title: Mirtazapine vs Sumatriptan in the Treatment of Postdural Puncture Headache Following Obstetric Surgery Under Spinal Anesthesia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Headache
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-11-05
Enrollment: 210
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Postdural puncture headache (PDPH) is a potential complication after spinal anesthesia caused by traction on pain-sensitive structures from low cerebrospinal fluid pressure (intracranial hypotension) following a leak of cerebrospinal fluid at the puncture site. Symptoms of this condition include a bilateral frontal or occipital headache that is worse in the upright position, along with nausea, neck pain, dizziness, visual changes, tinnitus, hearing loss, or radicular symptoms in the arms.

This study will examine the efficacy of mirtazapine in in the treatment of PDPH after obstetric surgery under spinal anesthesia and compared its efficacy with that of sumatriptan.


Eligibility criteria: Inclusion Criteria:

* ASA I and II Patients.
* Patients undergoing obstetric surgeries under spinal anesthesia. and complaining from moderate-to-severe PDPH after 25G or 27G spinal needle puncture.

Exclusion Criteria:

* Refusal of the intervention or participation in the study.
* Patient under age of 18 years old.
* Psychiatric illness.
* Patients with a history of ischemic heart disease, pregnancy-induced hypertension, chronic hypertension, cardiac, vascular, liver or renal impairment.
* Patients with a history of migraine.
* Patients with known hypersensitivity to study drugs.
* Patients currently using ergotamine, monoamine oxidase inhibitors, or selective serotonin reuptake inhibitors.

Primary outcomes:
measure: Incidence of refractory headache ((number of patients)(n),% of patients) (refractory: failed intervention and conservative treatment) after 72 hours
timeFrame: 72 hours after intervention (Day 0)
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain-Shams University Hospitals
Study officials:
References:
Clinical trial NCT04336488: Matrix Metalloproteinases Neutralizing Agents in Oral Lichen Planus
Official title: Effectiveness of Matrix Metalloproteinase Neutralizing Agent in Treatment of Oral Lichen Planus: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Oral Lichen Planus
Keywords: matrix metalloproteinase inhibitors, orochem, OLP
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2020-04-07
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double equal arms
Primary purpose: TREATMENT

Brief summary: The current study will be conducted to evaluate the effectiveness of matrix metalloproteinases inhibitors on erosive oral lichen planus.

Detailed description: Matrix metalloproteinases inhibitor (Orochem) will be given to patients with Oral erosive lichen planus three times daily for 3 weeks. Then the subjective discomfort and pain severity as well as the objective disease severity scores will be collected.

Eligibility criteria: Inclusion Criteria:

* patients diagnosed with erosive OLP confirmed with a biopsy.
* patients should have symptomatic lesions

Exclusion Criteria:

* Patients who were under anticoagulant medications, suffering from any systemic diseases or having any physical or mental abnormality, pregnant and lactating women, smokers.

Primary outcomes:
measure: change in disease severity score
timeFrame: change in disease severity score from baseline to 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: periodontology department, Faculty of dentistry, Alexandria University
Study officials:
affiliation: Alexandria University
name: Hossam H. AlSabbagh, As. lecturer
role: PRINCIPAL_INVESTIGATOR
References: