louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02033824: Amniotic Membrane in Decompressive Craniectomy to Reduce Scarring
Official title: A Multicenter Prospective Randomized Clinical Trial Using Dehydrated Human Amnion/Chorion Membrane dHACM in Decompressive Craniectomy Patients to Reduce Postoperative Scarring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scarring
Lead sponsor: MiMedx Group, Inc.
Sponsor class: INDUSTRY
First posted: 2014-01-13
Enrollment: 7
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 purpose of this study is to evaluate the effectiveness of dHACM in reducing scar tissue formation in craniectomy patients as well as facilitating reoperation and repair. Specifically this study compares craniectomy without dHACM application to craniectomy with placement of dHACM between the galea and dura over dural suture line and/or exposed parenchyma.


Eligibility criteria: Inclusion Criteria:

* Adults ages 18 or older.
* Diagnosed with closed head trauma or cerebral infarction where decompressive craniectomy with durotomy is performed.
* Willingness to comply with study procedures.
* The patient's or legally authorized representative's (LAR's) ability to give full written consent.

Exclusion Criteria:

* Prior surgery at the site
* Participation in another ongoing trial
* Open cranial wounds
* Site exhibits clinical signs and symptoms of local infection.
* Current diagnosis of cancer at the site
* Prior radiation therapy treatment at the site.
* Patients on any investigational drug(s) or therapeutic device(s) within 30 days preceding screening.
* Known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV.
* Presence of any condition(s) which seriously compromises the subject's ability to complete this study, or has a known history of poor adherence with medical treatment.
* Currently taking medications which could affect graft incorporation (supervising physician's discretion).
* Allergy to gentamicin sulfate and/or streptomycin sulfate

Primary outcomes:
measure: Degree of scarring between the galea and the dura, as assessed by the Ease of Dissection (EOD) Score and histological analysis upon reoperation in patients receiving craniectomy with durotomy.
timeFrame: 6 Months
Secondary outcomes:
measure: Intra- and post-operative complications at reoperation, as assessed by occurrence of violation of the dura and/or violation of the parenchyma.
timeFrame: 6 Months
measure: Post-operative complications at original and re-operation
timeFrame: 6 Months
measure: Peri-operative measures at original and re-operation
timeFrame: 6 Months
measure: Survival
timeFrame: 6 Months
Other outcomes:
Locations:
city: Boulder
country: United States
facility: Boulder Neurological Associates
state: Colorado
city: Chattanooga
country: United States
facility: Chattanooga Center for Neurological Research
state: Tennessee
Study officials:
affiliation: MiMedx Group, Inc.
name: Chris Clare, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00866424: Clinical Trial of Hyperbaric Oxygen Treatment in Trigeminal Neuralgia Patients
Official title: A Prospective Study on Efficacy of Hyperbaric Oxygenation Treatment for Patients With Trigeminal Neuralgia: a Randomized, Double-Blind, Mock Hyperbaric Chamber -Controlled, Parallel-Group Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Trigeminal Neuralgia
Pain
Keywords: trigeminal neuralgia
pain
HBO
VAS
MGPQ
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2009-03-20
Enrollment: 30
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 purpose of this study is to determine whether the hyperbaric oxygen treatment reduces pain and improve the life quality in trigeminal neuralgia patients.

Detailed description: Trigeminal neuralgia(TN) is a recurrent severe shooting neuropathic pain. Treatment of this pain continues to be a challenge in clinical pain management. Hyperbaric oxygen (HBO) has been used of neuropathic diseases, which can improve blood partial pressure of oxygen, reduce edema, relieve neural oppression and attenuate inflammatory response. The hypothesis of this protocol is that hyperbaric oxygen treatment could relieve neuropathic pain and improve the quality of life in TN patients. Visual analogue scale (VAS) and the mcgill pain questionnaire (MGPQ) will be assessed before the initiation of the study, after hyperbaric oxygen (HBO) treatment and at monthly intervals for the subsequent 3 months. Titration of dosage and pain frequency will be recorded throughout the study. Clinical global impression (CGI) by the individual patient will be evaluated at monthly intervals after HBO treatment.

Eligibility criteria: Inclusion Criteria:

1. Age 18-70
2. Primary TN patient (MRI examination support diagnosis)
3. Suffering from this pain for at least 3 months
4. VAS﹥40mm
5. Patient can assess pain intensity correctly

Exclusion Criteria:

1. Undergone surgery for TN(including nerve injections) within the last year
2. Oral medicine change within the last week
3. With other diseases of nervous system

Primary outcomes:
measure: visual analogue scales (VAS), the mcgill pain questionnaire (MGPQ).
timeFrame: after HBO treatment
Secondary outcomes:
measure: visual analogue scales (VAS), the mcgill pain questionnaire (MGPQ),pain frequency, titration of dosage, clinical global impression (CGI)
timeFrame: at monthly intervals for the subsequent 6 after hyperbaric oxygen (HBO) treatment
Other outcomes:
Locations:
city: Xi'an,
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
affiliation: Xijing Hospital, Fourth Military, Medical Univercity
name: Li ze Xiong, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04770324: Study of a Novel Interposition Supraciliary Implant in Patients With Open Angle Glaucoma (SAFARI 2)
Official title: Non Randomised Mono-centered Study to Evaluate Safety and Efficacy of a Novel Interposition Supraciliary Implant in Glaucoma Patients Refractory to Topical Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glaucoma, Open-Angle
Lead sponsor: Ciliatech
Sponsor class: INDUSTRY
First posted: 2021-02-25
Enrollment: 22
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of implanting 2 novel interposition supraciliary implant as a stand-alone therapy for lowering intraocular pressure (IOP) in patients with primary open angle glaucoma (POAG) who have failed at least one class of topical medical therapy

Detailed description: 20 patients will be included in this 6 months interventional study.

All patients shall be indicated for glaucoma surgery alone (not combined with cataract), and will undergo incisional glaucoma therapy, including a novel simplified surgical technique allowing placement of 2 interposition supraciliary permanent devices.

Several patient data like IOP, visual capacity or associated pharmacological treatments will be recorded pre and post-operatively all along the follow-up.

Purpose is to ensure device safety, and verify IOP and associated pharmacological treatment reduction after surgery, and evolution along follow-up.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of POAG Schafer 3 or 4
* Medicated IOP ≥ 21

Exclusion Criteria:

- Inflammatory, congenital, traumatic, neovascular, ICE syndrome, angle closure and Schaffer 1 and 2 glaucoma

Primary outcomes:
measure: Assess post-op IOP reduction
timeFrame: 6 months
measure: Assess post-op IOP clinical success
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Yerevan
country: Armenia
facility: Malayan Center
Study officials:
References:
Clinical trial NCT06370624: PEDI-REAVASC Resonance Imaging of Infants With Hypoxic Ischemic Encephalopathy After Hypothermia Treatment.
Official title: Quantitative Assessment of Cerebral Vascular Reactivity by Resting Functional Magnetic Resonance Imaging of Infants With Hypoxic Ischemic Encephalopathy After Hypothermia Treatment: Diagnostic and Prognostic Implications.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Encephalopathy, Hypoxic-Ischemic
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: One group will be followed - with both the standard of care continuous EEG monitoring and near infrared spectroscopy (NIRS) \& the MRI-scan performed at the same time.
Primary purpose: DIAGNOSTIC

Brief summary: This study is a prospective, observational, single-center study to assess the correlation between rs-fMRI measures and clinical measures of standard MRI, NIRS, EEG and clinical scores.

The target population was neonates with HIE referred to MRI after hypothermia treatment, which was initiated within 6 hours of birth, continued for 72 hours and followed by a slow rewarming period of 6-12 hours.

A one-year clinical and imaging follow-up is planned. As the aim of the present study is to assess the predictiveness of the outcome one year after the HIE event, no follow-up is planned.


Eligibility criteria: Inclusion Criteria:

Newborns at 36 weeks gestation or more, with HIE treated with therapeutic hypothermia will be prospectively included.

Exclusion Criteria:

* Lack of parental consent
* Congenital anomalies that make hypothermia treatment not indicated
* Coagulopathy with active bleeding

Primary outcomes:
measure: quantifying cerebrovascular reactivity (CVR) by resting-state functional MRI (r-fMRI) in infants with moderate to severe hypoxic-ischaemic encephalopathy (HIE)
timeFrame: at birth, directly after hypothermia and at 1 year of baby's life
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint Luc
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Valeria Onofrj, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02049424: Observational Study in Patients Who Underwent an Haploidentical Transplantation With T-repleted Bone Marrow
Official title: Retrospective-prospective Observational Study for Data Collection of Patients Who Underwent an Haploidentical Transplantation After Non-myeloablative Conditioning Regimen
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hematologic Malignancy
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2014-01-30
Enrollment: 9
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 who underwent a haploidentical transplantion after non-myeloablative conditioning regimen

Brief summary: Outcome evaluation in patients who underwent transplantation with T-repleted bone marrow after post-transplantation cyclophosphamide

Detailed description: Patients who underwent transplantation with T-repleted bone marrow haploidentical transplantation will be analyzed considering toxicity incidence (GVHD, infective complications, graft-failure incidence and TRM)and efficacy variables (Overall Survival, Progression Free Survival and Relapse incidence)

Eligibility criteria: Inclusion Criteria:

- patients affected by hematologic neoplasia who underwent a haploidentical transplantation (2-3 mismatches) from a familiar donor, with non-ex vivo manipulated bone marrow and post-transplantation cyclophosphamide

Exclusion Criteria:

* ex vivo manipulated bone marrow transplantation
* use of antilymphocyte serum during conditioning

Primary outcomes:
measure: toxicity evaluation
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: MI
Study officials:
affiliation: Istituto Clinico Humanitas
name: Luca Castagna, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roberto A, Castagna L, Zanon V, Bramanti S, Crocchiolo R, McLaren JE, Gandolfi S, Tentorio P, Sarina B, Timofeeva I, Santoro A, Carlo-Stella C, Bruno B, Carniti C, Corradini P, Gostick E, Ladell K, Price DA, Roederer M, Mavilio D, Lugli E. Role of naive-derived T memory stem cells in T-cell reconstitution following allogeneic transplantation. Blood. 2015 Apr 30;125(18):2855-64. doi: 10.1182/blood-2014-11-608406. Epub 2015 Mar 5.
citation: Roberto A, Castagna L, Gandolfi S, Zanon V, Bramanti S, Sarina B, Crocchiolo R, Todisco E, Carlo-Stella C, Tentorio P, Timofeeva I, Santoro A, Della Bella S, Roederer M, Mavilio D, Lugli E. B-cell reconstitution recapitulates B-cell lymphopoiesis following haploidentical BM transplantation and post-transplant CY. Bone Marrow Transplant. 2015 Feb;50(2):317-9. doi: 10.1038/bmt.2014.266. Epub 2014 Nov 24. No abstract available.
Clinical trial NCT06791824: Study of CM313(SC) Injection in Subjects With Relapsed/Refractory Aplastic Anemia
Official title: A Phase IB/II Clinical Study to Assess the Safety, Tolerability and Preliminary Efficacy of CM313(SC) Injection in Subjects With Relapsed/Refractory Aplastic Anemia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Aplastic Anemia
Lead sponsor: Keymed Biosciences Co.Ltd
Sponsor class: INDUSTRY
First posted: 2025-01-24
Enrollment: 125
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: This is a randomized, open-label, phase IB/II clinical study to evaluate the safety, tolerability and preliminary efficacy of CM313(SC) injection in patients with relapsed/refractory aplastic anemia


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of idiopathic aplastic anemia.
2. Patients must meet the requirements of relapsed/refractory aplastic anemia defined in the protocol.
3. Male or female, age≥18 years.
4. The Eastern Cooperative Oncology Group (ECOG) physical status score ≤2.
5. Willing and able to comply with the requirements for this study and written informed consent.

Exclusion Criteria:

1. The inherited bone marrow failure syndromes.
2. Previously treated with the anti-CD38 monoclonal antibody.
3. Have an allergy to humanized monoclonal antibody or any part of CM313.
4. Pregnant or breastfeeding females, or females planning to become pregnant during the study.
5. Any condition considered to be ineligible for the study by the investigator.

Primary outcomes:
measure: Adverse events (AE)
timeFrame: Up to 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Institute of Hematology & Blood Diseases Hospital
state: Tianjin
Study officials:
affiliation: Institute of Hematology & Blood Diseases Hospital, China
name: Jun Shi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05279924: Outcomes of Prophylaxis With Emicizumab in Children With Severe Hemophilia A in Ivory Coast
Official title: Impact of Implementation of Prophylaxis With Emicizumab in Children With Severe Hemophilia A in Ivory Coast
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemophilia A
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2022-03-15
Enrollment: 33
Sex: MALE
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: outcomes of prophylaxis with Emicizumab in Ivoirian boys with severe hemophilia A
Primary purpose: TREATMENT

Brief summary: Assessment of the outcomes of prophylaxis with Emicizumab in children with severe hemophilia A in Ivory Coast

Detailed description: Assessment of the outcomes of prophylaxis with Emicizumab in children with severe hemophilia A in Ivory Coast.

Duration of the study: 1 year after initiation of prophylaxis with Emicizumab

Inclusion criteria: boys aged \> 2 years, affected with severe hemophilia A with or without inhibitors

Evaluated outcomes: annual bleeding rate, days of absence from school, the need for additional facteur VIII consumption, satisfaction about the treatment and quality of life.

Tools used to assess quality of life are the Ivoirian version of the Canadian Haemophilia Outcomes-Kids' Life Assessment Tool version 2 (CHO-KLAT) and EQ-5D

The satisfaction of the parents will be assessed using the patients' global impression of change scale (PGIC).

Eligibility criteria: Inclusion Criteria: severe hemophilia A with or without inhibitors -

Exclusion Criteria: parents refusal

-

Primary outcomes:
measure: Change in annual bleeding rate
timeFrame: change in annual bleeding rate from baseline at 6 months and 12 months
measure: Change in the scores of HR-QoL tools CHO-KLAT and EQ-5D in children treated with Emicizumab
timeFrame: Change in the scores of HR-QoL tools CHO-KLAT and EQ-5D at 6 months.
measure: Satisfaction of the parents about the treatment with Emicizumab after 6 month
timeFrame: Assessment at 6 months after initiation of Emicizumab
Secondary outcomes:
Other outcomes:
Locations:
city: Abidjan
country: Côte D'Ivoire
facility: CHU de Yopougon
Study officials:
affiliation: CHU de Cocody
name: N'Dogomo Meité, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05685524: Clinical Study of Pan-cancer DNA Methylation Test in Plasma
Official title: Development of Diagnostic Model for Multi-cancer Diagnosis Based on DNA Methylation Biomarkers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Keywords: Colorectal cancer
Liver cancer
Squamous cell carcinoma of the head and neck
Esophageal carcinoma
Pancreatic cancer
Ovarian cancer
Bladder cancer
Cervical cancer
Lung cancer
Stomach cancer
Lead sponsor: Wuhan Ammunition Life-tech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-01-17
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 200 cases are planned for each cancer type, and the total number of samples in the cancer group is expected to be 2,000.The number of samples in the non-cancer group is expected to be 1000 cases。

Brief summary: We intend to establish an efficient method for plasma cfDNA extraction and Bisulfite transformation to facilitate the detection of DNA methylation status using multiplex fluorescence PCR. Meanwhile, we expect to identify several plasma methylation markers that can be highly sensitive for multi-cancer detection. Finally, we will provide a pan-cancer blood test that is easy to operate, low cost, accurate and easy to promote.


Eligibility criteria: Inclusion Criteria:

- (1)age \>= 18 years. (2) with high suspicion of cancer diagnosed by endoscopy, other imaging examinations, pathological examinations, etc.

(3) no treatment with radiotherapy or chemotherapy.

Exclusion Criteria:

* (1) received antineoplastic treatment such as radiation/chemotherapy. (2) not preserved as required. (3) contaminated or volume is insufficient. (4) unclear pathological results (5) incomplete patient information.

Primary outcomes:
measure: Sensitivity
timeFrame: immediately after the procedure
measure: Specificity
timeFrame: immediately after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: The first affiliated hospital of Zhengzhou University
state: Henan
Study officials:
References:
Clinical trial NCT01165424: A Study of Long-term Administration of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Study P06333AM1)
Official title: A Study of Long-term (12-24 Weeks) Administration of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Protocol No. P06333)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rhinitis, Allergic, Perennial
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2010-07-19
Enrollment: 80
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Mometasone furoate nasal spray (MFNS) is a once-a-day product. This is a multi-center, open-label study of MFNS in children with perennial allergic rhinitis. MFNS will be administered to pediatric subjects (3-15 years old) with perennial allergic rhinitis at a dose of 100 to 200 μg/day (once daily) for 12 weeks. Subjects (subject's legal representatives) provided consent to continue treatment beyond 12 weeks will receive treatment for up to 24 weeks. At each clinic visit, observation of adverse events, nasal symptom scores, and nasal findings will be evaluated. The presence/absence of serious adverse events and trial procedure-related AEs will be reviewed 30 days after the end of the follow-up.


Eligibility criteria: Inclusion Criteria:

* Subjects having symptoms of perennial allergic rhinitis of moderate to severe degree.
* Subjects confirmed to be allergic to non-seasonal environmental antigens (e.g., house dust mite antigen).
* Male or female outpatients aged 3 to 15 years at the time of providing informed consent.

Exclusion Criteria:

* Subjects with coexisting tuberculosis or lower respiratory tract infection, or who have an acute upper respiratory tract infection or acute pharyngolaryngitis, etc. judged by the investigator to require treatment at the time of registration
* Subjects with coexisting infections or systemic mycosis for which there are no effective antibiotics
* Subjects with repeated epistaxis
* Subjects with coexisting fungal infection in nasal/sinus cavity
* Subjects with a history of hypersensitivity to steroids or ingredients of mometasone furoate nasal spray
* Subjects with severe hepatic, renal, cardiac, hematological disease, diabetes mellitus, hypertension, or other serious coexisting diseases and whose general condition is poor.
* Subjects allergic to pollen (cedar, Japanese cypress, birch, grasses, mugwort, common ragweed, etc.) for whom the pollen season coincides with the observation period

Primary outcomes:
measure: Number of Participants With Adverse Events and Adverse Drug Reactions
timeFrame: Baseline to Week 24
Secondary outcomes:
measure: Change From Baseline in the Total Nasal Symptom Score
timeFrame: Baseline and Weeks 2, 4, 8, 12, and 24 (or discontinuation)
Other outcomes:
Locations:
Study officials:
References: