louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00180206: Birmingham Hip Resurfacing (BHR) Study: Implantation of a Hip Resurfacing Endoprosthesis
Official title: Prospective, Non-Randomised, Non-Comparative Multicentric Investigation of the Functional and Radiological Result and Subjective Patient Outcome After Implantation of a Hip Resurfacing Endoprosthesis (Birmingham Hip Resurfacing)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Arthritis
Keywords: Arthritis
Hip
Hip arthroplasty
Hip resurfacing arthroplasty
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is the investigation of the functional and radiological results and subjective patient outcome after the implantation of a hip resurfacing endoprosthesis (Birmingham hip resurfacing).

Detailed description: High volumetric wear of polyethylene was the main factor in periprosthetic bone resorption and failure of historic hip resurfacing prosthesis. Metal-on-metal devices reduce the wear substantially and may solve this problem. The purpose of this study is the investigation of the functional and radiological result and subjective patient outcome after implantation of a hip resurfacing endoprosthesis (Birmingham Hip Resurfacing) during the first two years after surgery.

Eligibility criteria: Inclusion Criteria:

* Clinical and radiological signs of coxarthritis
* Implantation of a total hip replacement indicated
* Informed consent

Exclusion Criteria:

* Osteoporosis
* Tumor
* Acute infection
* Higher grade congenital dysplasia of the hip
* Pregnancy

Primary outcomes:
measure: Functional result
measure: Radiological result
measure: Subjective patient outcome
Secondary outcomes:
measure: Perioperative and postoperative complication rate
measure: Revision rate
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Department of Orthopaedic Surgery, University Hospital, Technical University of Dresden
Study officials:
affiliation: Department of Orthopaedic Surgery, University Hospital Carl Gustav Carus, Technical University of Dresden
name: Klaus-Peter Guenther, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01229306: Repeat Ablation Procedure in Patients With Relapse of Atrial Fibrillation
Official title: Repeat Ablation Procedure in Patients With Relapse of Paroxysmal Atrial Fibrillation Using Reisolation of Pulmonary Vein Versus Reisolation of Pulmonary Vein With Additional Anterior Line
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ablation
Paroxysmal Atrial Fibrillation
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
First posted: 2010-10-27
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Catheter ablation with isolation of the pulmonary veins has proven to be an effective treatment option in patients with paroxysmal atrial fibrillation. In patients who have a relapse of paroxysmal atrial fibrillation after one ablation procedure the investigators compare the reisolation of all pulmonary veins to reisolation plus an anterior left atrial line.

Detailed description: Catheter ablation with isolation of the pulmonary veins has proven to be an effective treatment option in patients with paroxysmal atrial fibrillation. In patients who have a relapse of paroxysmal atrial fibrillation after one ablation procedure we compare the reisolation of all pulmonary veins to reisolation plus an anterior left atrial line.

Eligibility criteria: Inclusion Criteria:

* relapse of atrial fibrillation

Exclusion Criteria:

* contraindication for ablation

Primary outcomes:
measure: Freedom of atrial arrhythmias
Secondary outcomes:
measure: Quality of life, number of reconnected pulmonary veins, safety
Other outcomes:
Locations:
city: München
country: Germany
facility: Deutsches Herzzentrum
state: Bayer
Study officials:
References:
Clinical trial NCT06013306: Long-Term Follow-up Study of Subjects With Knee Osteoarthritis Who Had Administered FURESTEM-OA Kit Inj. in K0701 Study
Official title: Long-Term Follow-up Study of Subjects With Knee Osteoarthritis Who Had Administered FURESTEM-OA Kit Inj. in K0701 Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Knee Osteoarthritis
Lead sponsor: Kang Stem Biotech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-08-28
Enrollment: 58
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Those who participated in the K0701 clinical trial and received PureStem-OA Kit Inj

Brief summary: Long-Term Follow-up Study of Subjects with Knee Osteoarthritis who had administered FURESTEM-OA Kit Inj. in K0701 study


Eligibility criteria: Inclusion Criteria:

* Those who participated in the K0701 clinical trial and received PureStem-OA Kit Inj
* Those who understand and voluntarily sign an informed consent form

exclusion criteria

* None

Primary outcomes:
measure: Number of AESI
timeFrame: 5 years follow-up after treatment
measure: Number of SS
timeFrame: 5 years follow-up after treatment
Secondary outcomes:
measure: Changes in Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment
measure: Changes in Western Ontario and McMaster Universities osteoarthritis index (WOMAC)
timeFrame: 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment
measure: Changes in 100-mm VAS
timeFrame: 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment
measure: Changes in International Knee Documentation Committee Scoring System (IKDC)
timeFrame: 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment
measure: Evaluation of International K&L grade(X-ray)
timeFrame: 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment
measure: Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scores(MRI)
timeFrame: 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment
measure: Whole-Organ Magnetic Resonance Imaging Score (WORMS) score
timeFrame: 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment
Other outcomes:
Locations:
Study officials:
affiliation: Kyung Hee University Hospital
name: Kyoung-Ho Yoon, professor (CI)
role: PRINCIPAL_INVESTIGATOR
affiliation: Gangdong Kyunghee University Hospital
name: Sang Hak Lee, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04803006: A Study of TCD601 in the Induction of Tolerance in Renal Transplantation (PANORAMA)
Official title: An Adaptive, Regimen Finding, Safety and Tolerability Study of TCD601 (Siplizumab), a Human Anti-CD2 Antibody, Combined With Donor Bone Marrow Cell Infusion and Non-myeloablative Conditioning, for Tolerance Induction in Living Donor Renal Transplantation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Kidney Transplantation
Lead sponsor: ITB-Med LLC
Sponsor class: INDUSTRY
First posted: 2021-03-17
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the optimal regimen for the use of siplizumab, a human anti-CD2 antibody, combined with donor bone marrow cells and non-myeloablative conditioning, for tolerance induction in living donor renal transplantation


Eligibility criteria: Key Inclusion Criteria:

* Able to understand the study requirements and provide written informed consent before any study assessment is performed
* Male or female patients ≥ 18 to 65 years of age
* Recipient of a first renal transplant from a non-HLA identical, but at least haploidentical, ABO compatible living donor

Key Exclusion Criteria:

* Women of child-bearing potential, unless willing to comply with the use of highly effective methods of contraception as defined by the protocol
* A history of cancer other than basal cell carcinoma of the skin or carcinoma in situ of the cervix
* Recipient with anti-HLA donor-specific antibody (DSA)

Primary outcomes:
measure: The optimal regimen for renal allograft tolerance while minimizing chimeric transition syndrome
timeFrame: 24 months
Secondary outcomes:
measure: The incidence of biopsy proven acute rejection, death and graft loss
timeFrame: 24 months
measure: The incidence of de novo donor-specific antibody
timeFrame: 24 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Connie Frank Transplant Center
state: California
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Livingston
country: United States
facility: Cooperman Barnabas Medical Center
state: New Jersey
city: New York
country: United States
facility: NYU Langone
state: New York
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: ITB-MED
name: Nick Hryciw, MA
role: STUDY_DIRECTOR
References:
Clinical trial NCT04337606: Chidamide in Combination With Decitabine in Non-Hodgkin's Lymphoma Relapsed After Chimeric Antigen Receptor
Official title: Chidamide in Combination With Decitabine in Non-Hodgkin's Lymphoma Relapsed After Chimeric Antigen Receptor : An Open-label Phase I/II Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Non Hodgkin Lymphoma
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2020-04-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase I/II clinical trial for patients with r/r Non-Hodgkin's Lymphoma relapsed after chimeric antigen receptor T cells infusion. The purpose is to evaluate the safety and efficacy of the treatment with chidamide in combination with decitabine.


Eligibility criteria: Inclusion Criteria:

1. Subjects must have histological confirmation of Non-Hodgkin lymphoma (NHL) and relapsed after chimeric antigen receptor T cells infusion.
2. 18 to 65 years of age.
3. ECOG performance of less than 2.
4. Life expectancy of at least 3 months.
5. Subjects with lymphoma must have at least one measureable new lesion \>1.5cm as defined by lymphoma response criteria.
6. Subjects must have relapsed after chimeric antigen receptor T cells infusion without any intervention treatment prior to Day 1.
7. Subjects must have adequate marrow, live, renal and heart functions.

Exclusion Criteria:

1. Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.
2. Serious uncontrolled medical disorders or active infections, pulmonary infection especially.
3. Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in one month .
4. Prior organ allograft.
5. Women who are pregnant or breastfeeding.
6. Women with a positive pregnancy test on enrollment or prior to investigational product administration.
7. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness

Primary outcomes:
measure: CR rate
timeFrame: 2 years
measure: Adverse events
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Biotherapeutic Department of Chinese PLA General Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT06589206: Three-Dimensional Assessment of Dentoskeletal Changes Associated With a Modified Twin Block Appliance
Official title: Three-Dimensional Assessment of Dentoskeletal Changes Associated With a Modified Twin Block Appliance for Treatment of Skeletal Class II Growing Patients With Mandibular Deficiency: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Growth Modification
Keywords: twin block
esthetic twin block
clear twin block
Deficient mandible
Skeletal Class II
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 30
Sex: MALE
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the current study is to evaluate the skeletal, dental, soft tissue, TMJ, and upper airway size changes associated with a new design of twin block compared to the conventional twin block appliance. Additionally, patients' satisfaction with the two designs will be assessed.

Detailed description: Twin block appliance is the gold standard for the treatment of skeletal class II patients with deficient mandible. Yet, it has some drawbacks as proclination of the mandibular incisors, development of posterior open bite and the unesthetic appearance. Many modifications in twin block A new design were made to overcome the previous problems, as adding incisor capping, Clasps, sagittal blocks, and esthetic twin block appliances. In the current trial A new design of esthetic twin block appliance with sagittal blocks is investigated and the post treatment skeletal, dental, and soft tissue, TMJ, and upper airway size will be assessed and compared to the changes associated with the conventional design of twin block. Moreover, patient satisfaction with the appliance will be assessed with both appliances.

Eligibility criteria: Inclusion Criteria:

* skeletal class II deficient mandible
* Class II molar and canine relation
* male growing patients CVM 2,3 age range 10-14
* normal vertical growth pattern
* ANB \> 4
* mild to moderate crowding

Exclusion Criteria:

* Previous orthodontic treatment.
* Craniofacial syndrome.
* Periodontal disease.
* Extracted first permanent molars.

Primary outcomes:
measure: skeletal changes
timeFrame: 9 months
measure: Dental changes
timeFrame: 9 months
Secondary outcomes:
measure: soft tissue changes
timeFrame: 9 months
measure: JMJ changes
timeFrame: 9 months
measure: Upper airway size
timeFrame: 9 months
measure: patient satisfaction
timeFrame: after one and nine months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03790306: Opioid Free and Therapy Minimized Advantages Using HANA Table for Total Hip Arthroplasty
Official title: Opioid Free and Therapy Minimized Advantages Using HANA Table for Total Hip Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthropathy of Hip Joint
Osteoarthritis, Hip
Lead sponsor: St. Elizabeth Medical Center, Utica, NY
Sponsor class: OTHER
First posted: 2018-12-31
Enrollment: 207
Sex: ALL
Minimum age (years): 30
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Males and females presenting seeking elective unilateral total hip arthoplasty that fall within inclusion criteria listed above

Brief summary: To prove that anterior approach total hip arthroplasty using the HANA table can be performed with little, if any, need for opioids using a combination of education, optimized pre op and post op pain protocols and optimized recovery tools.

Detailed description: Methods:

Data Collection:

* pre-op assessment/physical therapy evaluation
* post op assessment - PACU, phase II (Prior to discharge)
* phone calls after discharge (post op day 1, 2, 3)
* follow up assessment in surgeon's office (3 and 6 weeks post op)
* Ortech
* Swiftpath
* HOOS jr

Pre-optimization:

* All patients enroll in SwiftPath education program
* Optimized BMI, hemoglobin, albumin, glucose control, A1C and blood pressure control

Total Joint procedure:

-anterior approach using the HANA table THA preformed with intra-articular block

Pain Management regimen:

* Pre op PT teaching
* post op multimodal pain regimen

Eligibility criteria: Inclusion Criteria:

* Elective total hip arthroplasty
* unilateral
* patient surgeries scheduled to be performed at the hospital and surgery center
* patients must enroll in SwiftPath
* Ability to read and understand English

Exclusion Criteria:

* Patient diagnosis of schizophrenia, bipolar disease, dementia
* previous burn to affected extremity
* BMI \> 40
* Hemoglobin \<12 female, \<13 male
* Albumin less than 3.5
* A1C \>8.0

Primary outcomes:
measure: Pre-operative Narcotic Use
timeFrame: Pre-operatively
measure: Number of Patients That Took Any Opioids Throughout 6-week Follow-up Period
timeFrame: 6 weeks
measure: Short Physical Performance Battery
timeFrame: 6 Weeks
Secondary outcomes:
measure: Numeric Pain Scores
timeFrame: 6 Weeks
measure: Sleep Quality
timeFrame: 6 Weeks
measure: Number of Participants Who Adhere to Prescribed Post op Recovery Protocol
timeFrame: 2 weeks
measure: Length of Stay in Hospital
timeFrame: 1 week
measure: Number of Patients That Return to Work 6 Weeks After Surgery
timeFrame: 6 weeks
measure: Number of Patients Who Return to Driving 6 Weeks After Surgery
timeFrame: 6 Weeks
Other outcomes:
Locations:
city: Utica
country: United States
facility: St. Elizabeth's Medical Center
state: New York
Study officials:
affiliation: St. Elizabeth's Medical Center
name: Andrew Wickline, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04397406: Dexmedetomidine or Fentanyl as Additives to Epidural Levobupivacaine in Painless Labor
Official title: Role of Dexmedetomidine or Fentanyl as Additives to Epidural Levobupivacaine in Painless Labor: A Double Blind Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Epidural Analgesia
Painless Labor
Dexmedetomidine
Fentanyl
Levobupivacaine
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-05-21
Enrollment: 90
Sex: ALL
Minimum age (years): 21
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomly allocated into three equal groups by computer generated sequence through sealed opaque envelopes. Each group will include 30 patients.

Group C (Control group): Epidural analgesia with levobupivacaine alone Group D (Dexmedetomidine group): Epidural analgesia with levobupivacaine and dexmedetomidine Group F (Fentanyl group): Epidural analgesia with levobupivacaine and fentanyl
Primary purpose: TREATMENT

Brief summary: Central neuraxial analgesia has been extensively used for labor analgesia and is currently the gold standard technique for pain control in obstetrics.

The aim of the study will be to compare the role of dexmedetomidine or fentanyl as additives to epidural levobupivacaine in painless vaginal delivery as regard maternal analgesia and safety.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status class II and III,
* Full term pregnancy.

Exclusion Criteria:

* Patient refusal to epidural analgesia,
* Contraindications of epidural analgesia (coagulopathy, local infection, vertebral deformity hypersensitivity to levobupivacaine, dexmedetomidine or fentanyl, hemodynamic instability, severe aortic or mitral stenosis),
* Cardiac diseases
* Severe pre-eclampsia,
* Breech presentations
* Antepartum hemorrhage
* Cephalopelvic disproportion
* Body mass index ≥40 kg/m2.

Primary outcomes:
measure: Duration of maternal analgesia
timeFrame: 24 hours after epidural injection
Secondary outcomes:
measure: Onset of maternal analgesia.
timeFrame: One hour after epidural injection
measure: Complications of drugs of epidural technique
timeFrame: 24 hours after epidural injection
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospitals
state: Gharbiya
Study officials:
References:
Clinical trial NCT04310306: First-pass Recanalization With EmboTrap II in Acute Ischemic Stroke (FREE-AIS)
Official title: First-pass Recanalization With EmboTrap II in Acute Ischemic Stroke (FREE-AIS)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Ischemic Stroke Due to Intracranial Large Artery Occlusion
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2020-03-17
Enrollment: 310
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute stroke due to ELVO within 24 hours after last seen well

Brief summary: This study is a prospective, open-label, multi-center, registry study, designed to to documents that EmboTrap II usage as a thrombectomy device for emergency large vessel occlusion (ELVO) in terms of the rate of First Pass Recanalization (FPR). Patients with ELVO will initially underwent mechanical thrombectomy usig EmboTrap II. FPR is defined as modified Tissue Thrombolysis In Cerebral Ischemia (mTICI) 2b or 3


Eligibility criteria: Inclusion Criteria:

1. Subjects experiencing acute ischemic stroke due to large vessel occlusion (intracranial internal carotid artery and middle cerebral artery M1 or proximal M2 segment, intracranial vertebral artery and basilar artery
2. Age 19 or greater
3. mRS before qualifying stroke, 0 to 2
4. Baseline NIHSS score 4 or more
5. CT ASPECTS \> 5 or MR ASPECTS \> 4
6. Good collateral statues on CT angiogram (collateral grade by Calgary group, 4 or 5) or corresponding to DEFUSE 3 or DAWN trial on perfusion imaging.
7. Onset (last-seen-well) time to femoral puncture time \< 24 hours
8. Anticipated life expectancy of at least 12 months
9. Patients who undergo endovascular thrombectomy with EmboTrap II as the first-line device
10. Signed informed consent for study enrollment

Exclusion Criteria:

1. Multiple simultaneous large vessel occlusions
2. Pregnancy
3. Severe contrast allergy or absolute contraindication to iodinated contrast agent
4. Patient has a severe or fatal combined illness that will prevent improvement of follow-up or will render the procedure unlikely to benefit the patient.

Primary outcomes:
measure: First Pass Recanalization (FPR) rate
timeFrame: Within 1 day after the completion of endovascular thrombectomyh
Secondary outcomes:
measure: The rate of modified Rankin scale 0-2 at 3 months after treatment
timeFrame: 90 days ± 14 days
Other outcomes:
Locations:
city: Seongdu
country: Korea, Republic of
facility: Severance Hospital Stroke Center, Yonsei University College of Medicine
Study officials:
References: