louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01345058: Add on Lacosamide Versus High Dose Monotherapy
Official title: Open Label Trial of Add on Lacosamide Versus High Dose Monotherapy in Patients With a Seizure Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Keywords: Epilepsy
antiepileptic drug
polytherapy
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2011-04-29
Enrollment: 56
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: This is a study to determine whether a combination of low dose lacosamide and levetiracetam is more effective than high dose levetiracetam in patients who have failed low dose levetiracetam.


Eligibility criteria: Inclusion Criteria:

1. Adults age 18 or older
2. Determined to have had at least two partial seizures by an epilepsy specialist, or to have had a single partial seizure with clinical and/or laboratory evidence of a high seizure recurrence risk
3. Monotherapy on levetiracetam less than or equal to 1500 mg/day for at least two weeks
4. Breakthrough seizure while on stable dose (\>5 days) of levetiracetam monotherapy regimen, not due to provocative factors (e.g. hypoglycemia, head trauma, missed medications)

Exclusion Criteria:

1. Clinical suspicion of nonepileptic psychogenic seizures or idiopathic generalized epilepsy
2. Pregnant, child-bearing age not using contraception, or breast feeding
3. Medical contraindication to adding lacosamide
4. History of antiepileptic drug (AED) polytherapy
5. Presence of a vagus nerve stimulator
6. Creatinine clearance of less than 50 mL/min
7. Blood pressure instability: pulse \<50 or \>100, systolic blood pressure (SBP) \<50 or \>180, clinically significant electrocardiogram (EKG) abnormality
8. History of significant drug rash or anaphylactic reaction with antiepileptic drug
9. Patients with progressive lesions (e.g. brain tumors)

Primary outcomes:
measure: Percentage of Participants Achieving Six Month Seizure Freedom
timeFrame: 6 Months
Secondary outcomes:
measure: Number of Seizure-Free Days
timeFrame: 6 Months
measure: Time to First Seizure After Therapeutic Dose is Reached
timeFrame: 6 Months
measure: Retention Rate
timeFrame: 6 Months
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAE)
timeFrame: 6 Months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Jong Woo Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee JW, Alam J, Llewellyn N, Hurwitz S, Bubrick EB, Sarkis RA, Weisholtz D, Yu H, Putta S, Dworetzky BA, Pennell PB. Open Label Trial of Add on Lacosamide Versus High Dose Levetiracetam Monotherapy in Patients With Breakthrough Seizures. Clin Neuropharmacol. 2016 May-Jun;39(3):128-31. doi: 10.1097/WNF.0000000000000144.
Clinical trial NCT05921058: The Effects of Mesenchymal Stem Cell Secretome in Lupus Patients
Official title: The Effects of Mesenchymal Stem Cell Secretome in Lupus Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Lupus Erythematosus
Keywords: Messenchymal Stem Cell Secretome
Lupus
Lead sponsor: Universitas Sebelas Maret
Sponsor class: OTHER
First posted: 2023-06-27
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was divided into two groups, namely, control and treatment. Both received intervention in the form of a 1.5 cc injection on the scheduled day
Primary purpose: TREATMENT

Brief summary: This research is a clinical trial of administering mesenchymal stem cell secretome to lupus patients.

Detailed description: This research is experimental. The study was conducted on 30 SLE patient subjects. the treatment group who got the mesenchymal stem cell secretome on the 1st, 2nd day, 3rd, 4th, 5th, 6th, 7th, 14th, 21st, and 28th days. ESR, hs-CRP, C3, C4, interlukin 6, anti-ds-DNA antibody, MEX SLEDAI score, and assessment of drug side effects before and after therapy were collected. Statistical test with paired difference test with p \< 0.05

Eligibility criteria: Inclusion Criteria:

* Lupus paatients

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: Lupus Disease activity
timeFrame: Change of Lupus Disease Activity at 1 months
Secondary outcomes:
Other outcomes:
Locations:
city: Surakarta
country: Indonesia
facility: Moewardi General Hospital
state: Middle Java
Study officials:
affiliation: Universitas Sebelas Maret
name: Nurhasan Agung Prabowo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pratama YS, Pradiptakirana R, Rachmah A, Prabowo NA. Autoimmune Thrombocytopenia in SLE and COVID-19. Eur J Case Rep Intern Med. 2021 Nov 3;8(11):002863. doi: 10.12890/2021_002863. eCollection 2021.
citation: Sholihah MM, Kusuma TRH, Hanif MI, Prabowo NA. Letter to the Editor on Type 1 diabetes onset triggered by COVID-19. Acta Diabetol. 2021 Sep;58(9):1283-1284. doi: 10.1007/s00592-021-01761-3. Epub 2021 Jun 28. No abstract available.
Clinical trial NCT02656758: Intensive Executive Function Training
Official title: A Randomized Controlled Study on the Effect of Intensive Functional Training on Children With Attention Deficit Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2016-01-15
Enrollment: 80
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators intent to recruit 80 attention deficit hyperactivity disorder families. The attention deficit hyperactivity disorder families had received executive function training one year before.They will be randomized to intervention group and control group using a block randomization design. The intervention group will participate in intensive executive function training immediately,while the control group will receive executive training after 3 months.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of child attention deficit hyperactivity disorder
* full-scale intelligence quotient (FSIQ) ≥70
* stable on medication for attention deficit hyperactivity disorder children at least 3 months
* participation in the early implementation of functional training one year before

Exclusion Criteria:

* individuals with major neurological disorders
* a diagnosis of schizophrenia, epilepsy, mental retardation or other brain disorders

Primary outcomes:
measure: Change in attention deficit hyperactivity disorder-rating scale
timeFrame: baseline, after the training (12 weeks)
Secondary outcomes:
measure: Change in behavior rating scale of executive function
timeFrame: baseline, after the training (12 weeks)
measure: Cambridge Neuropsychological Test Automatic Battery
timeFrame: baseline, after the training (12 weeks)
measure: Behavior Rating Inventory of Executive Function
timeFrame: baseline, after the training (12week)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Sixth Hospital/Institute of Mental Health
state: Beijing
Study officials:
affiliation: Peking University Sixth Hospital/Institute of Mental Health
name: Ying Qian
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06975358: Accelerated Orthodontics With Alveolar Decortication Plus CGF Injection
Official title: Impact of Alveolar Decortication Combined With CGF Injection on Acceleration of Maxillary Canine Retraction-A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Accelerate Tooth Movement
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 24
Sex: ALL
Minimum age (years): 16
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to evaluate alveolar bone decortication combined with CGF Injection on tooth movement acceleration


Eligibility criteria: Inclusion Criteria:

1. Age of the patients ranged from 16: 22 years old.
2. Malocclusion that requires extraction of the maxillary first premolar and canine retraction (e.g. class I bimaxillary dentoalveolar protrusion and class II div 1 malocclusion).
3. Maximum anchorage needed for the maxillary arch as a part of the orthodontic treatment plan.
4. Good oral hygiene and periodontal condition.

Exclusion Criteria:

1. Medically compromised patients.
2. Severe crowding in the maxillary arch.
3. Chronic intake of NSAIDs or any medication that interfere with OTM.
4. Previous orthodontic treatment.

Primary outcomes:
measure: rate of canine retraction
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
Study officials:
References:
Clinical trial NCT00272558: Study of Carboplatin and Vinorelbine in Malignant Pleural Mesothelioma
Official title: Phase II Study of Carboplatin and Vinorelbine i.v. (Day 1) and Orally (Day 8) for Malignant Pleural Mesothelioma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Malignant Pleural Mesothelioma
Keywords: Malignant Pleural Mesothelioma
Chemotherapy
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2006-01-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose is to evaluate the activity and feasibility of a two drug regimen which is partly orally and partly intravenous in advanced pleural mesothelioma.

Detailed description: Chemotherapy with carboplatin i.v. day one in each cycle Vinorelbine i.v. day one, and orally day 8 in each cycle, repeat new cycle every 3 weeks. Total of 6 cycles.

Endpoint is response rate, secondary endpoints survival and toxicity.

Eligibility criteria: Inclusion Criteria:

* Histologically verified malignant pleural Mesothelioma
* Age above 18 years
* Performance status 0-2

Exclusion Criteria:

* No previous chemotherapy
* Normal renal, liver and bone marrow function

Primary outcomes:
measure: Response
Secondary outcomes:
measure: Survival
measure: Feasibility
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Dept. Oncol., Rigshospitalet
Study officials:
affiliation: Dept. Oncology, Rigshospitalet
name: Jens B Sorensen, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04545658: Prediction of Esophageal and Lung Toxicities After Radiation (Chemo) Therapy
Official title: Prediction of Esophageal and Lung Toxicities After Radiation (Chemo) Therapy for Lung Cancer Management
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2020-09-11
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stage I, II, III lung cancer patients treated with (chemo)-radiotherapy

Brief summary: (Chemo)-radiotherapy is the gold standard therapeutic treatment for patients with locally advanced lung cancer non accessible or ineligible for surgery. While some progress occurred regarding progression free survival and overall survival thanks to recent advances (i.e., durvalumab), prediction of pulmonary and esophageal toxicity, remains insufficiently accurate. Current dose-volume histograms (DVH) do not account for spatial dose distribution and strict application of current dose constraints does not prevent toxicity events in some of the treated patients. The goal of this work was to investigate the added predictive value of the radiomics approach applied to dose maps regarding acute and late toxicity in both lungs and the esophagus.


Eligibility criteria: Inclusion Criteria:

* Patients treated by (chemo)-radiotherapy for a primary lung cancer by radiotherapy

Exclusion Criteria:

* Incomplete treatment

Primary outcomes:
measure: Prediction of Acute Pulmonary Toxicity
timeFrame: Up to 6 months
measure: Prediction of Late Pulmonary Toxicity
timeFrame: Between 6 months and 2 years after radiotherapy
measure: Prediction of Acute Oesophageal Toxicity
timeFrame: Up to 6 months
measure: Prediction of Late Oesophageal Toxicity
timeFrame: Between 6 months and 2 years after radiotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU Brest
state: Finistère
Study officials:
References:
Clinical trial NCT02000258: Effect of Tunnel Placements on Clinical and MRI Findings Two Years After ACL Reconstruction With DB Technique
Official title: Effect of Tunnel Placements on Clinical and MRI Findings Two Years After Anterior Cruciate Ligament Reconstruction With Double-Bundle Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Cruciate Ligament Rupture
Keywords: Anterior cruciate ligament reconstruction
Double-bundle
MRI
Graft location
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2013-12-04
Enrollment: 75
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Purpose: To find out whether the clinical and MRI findings two years after anterior cruciate ligament (ACL) reconstruction were associated with each other so that MRI-based graft invisibility in the anteromedial (AM) graft would have an impact on anteroposterior stability of the knee, and MRI-based posterolateral (PL) graft invisibility on rotational stability of the knee.

Methods: 75 patients. One experienced orthopaedic surgeon performed all double-bundle (DB) ACL reconstructions. Two independent examiners made the clinical examinations at the two-year follow-up: clinical examination of the knee, KT-1000, International Knee Documentation Committee (IKDC) and Lysholm knee evaluation scores and IKDC functional score. The MRI evaluations were made by two musculoskeletal radiologists separately and the means of these measurements were used.


Eligibility criteria: Inclusion Criteria:

* primary ACL reconstruction, closed growth plates

Exclusion Criteria:

* ligament injury to the opposite knee

Primary outcomes:
measure: The location of the ACL grafts in the insertion site in the femur and in the tibia reported as percentages
timeFrame: 2 years after surgery
measure: The visibility of the ACL grafts measured from the MRI
timeFrame: 2 years after surgery
Secondary outcomes:
measure: KT-1000 measurement (mm) of the knees of 61 patients
timeFrame: 2 years after surgery
measure: International Knee Documentation Committee (IKDC) functional score
timeFrame: 2 years after surgery
measure: Lysholm knee evaluation score
timeFrame: 2 years after surgery
measure: Clinical evaluation of the knees on the basis of International Knee Documentation Committee (IKDC) examination form
timeFrame: 2 years after surgery
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University hospital
Study officials:
affiliation: Arthroscopic and sports medicine center Omasairaala, Helsinki, Finland
name: Timo Järvelä, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01606358: Influence of Chemotherapy on Gamma-delta T Cells in Patients With Epithelial Ovarian Cancer
Official title: IClyCO Influence of Chemotherapy (Carboplatin and Taxol) on the ex Vivo Expansion and Functional Capacity of Gamma-delta T Cells in Patients With Epithelial Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Ovarian Cancer
Keywords: Ovarian Cancer
Patient with ovarian cancer
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2012-05-25
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with proven epithelial ovarian cancer and receiving carboplatin and / or taxol chemotherapy.

Brief summary: In patients with an ovarian cancer, the treatment is currently based on surgery and chemotherapy.

The impact of chemotherapy on the expansion and functional abilities of Vgamma9Vdelta2 T cells has never been evaluated.

The long term goal is to give a rational to combine conventional treatment of ovarian cancer with immunotherapy based on Vgamma9Vdelta2 T cells.

Detailed description: Ovarian cancer is associated with a high mortality rate. Treatment of ovarian cancer is currently based on surgery and chemotherapy.

The first surgery is a radical surgical procedure aiming to achieve no residual disease. Patients who could not benefit from the first surgery may be offered neoadjuvant chemotherapy with a new surgical procedure after 3 or 6 chemotherapy cycles. Chemotherapy is currently based on Taxol and Carboplatin. Immunotherapy based on Vgamma9Vdelta2 T cells could provide a promising therapeutic strategy, however, the impact of chemotherapy on the expansion and functional abilities of Vgamma9Vdelta2 T cells has never been evaluated.

We want to study the effect of chemotherapy of ovarian cancer on Vgamma9Vdelta2 T cells rates in the peripheral blood of patients with ovarian cancer.

Functional abilities of the Vgamma9Vdelta2 T cells will be studied: expansion after chemotherapy and their cytotoxic abilities in an autologous context before or after chemotherapy.

The long term goal is to give a rational to combine conventional treatment of ovarian cancer with non-conventional treatment such as immunotherapy based on Vgamma9Vdelta2 T cells.

Eligibility criteria: Inclusion Criteria:

* Patients with proven epithelial ovarian cancer
* Patients receiving carboplatin and / or taxol chemotherapy.

Exclusion Criteria:

* Minor patient
* Protected adult
* Lack of invasion to the final histological checking
* Absence of chemotherapy in the therapeutic plan of treatment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU de RENNES
Study officials:
affiliation: Rennes University Hospital
name: Bruno Laviolle, MD PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01213758: Changes in Liver Function After Stereotactic Body Radiation Therapy Measured by PET/CT
Official title: Radiation Induced Change of Liver Function Measured by Uptake of the Galactose Analogue FDGal and PET/CT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Cholangiocarcinoma
Metastases
Stereotactic Body Radiotherapy
Keywords: liver function
galactose
18-F-deoxy-galactose
PET/CT
stereotactic body radiation therapy
SBRT
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Danish Cancer Society
First posted: 2010-10-04
Enrollment: 14
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: PROBABILITY_SAMPLE
Study population: Patients with liver tumors reffered for stereotactic body radiation therapy

Brief summary: Patients treated with stereotactic radiotherapy for liver tumors undergo PET/CT using the galactose analogue 18-F-deoxy-galactose (FDGal) before and after radiotherapy. This technique provides volumetric mapping of liver function and it allows quantisation of liver function. The method may be used for selection of patients for stereotactic radiotherapy of liver tumors, for determination of radiation induced liver dysfunction and may be included into the treatment planning process of stereotactic radiotherapy.


Eligibility criteria: Inclusion Criteria:

* liver tumor
* referred for stereotactic radiation therapy
* age \> 18 years

Exclusion Criteria:

* Impaired kidney function
* Pregnancy

Primary outcomes:
measure: Uptake of FDGal
timeFrame: Before, 1 month and 3 months after stereotactic radiotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Morten Høyer, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06963658: Acute Effect of Isometric Excercise on Pain Sensitivity in Adults With Chronic Low Back Pain
Official title: Acute Effect of Isometric Excercise on Pain Sensitivity in Adults With Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Low Back Pain (CLBP)
Keywords: pain sensitivity
isometric exercise
low back pain
Lead sponsor: Taif University
Sponsor class: OTHER
First posted: 2025-05-09
Enrollment: 90
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: Randomized control trial to examine the immediate effect of isometric exercise on pressure pain threshold (PPT) in adults with chronic low back pain. The secondary aim of this study was to investigate the acute effects of isometric exercise on clinical pain intensity.

Detailed description: Participants will attend a single visit to the hospital for two hours, which will include collecting demographic details and clinical characteristics through self-reported assessment scales. After that, outcome measures (pain sensitivity and current low back pain intensity) were collected prior to the intervention and repeated immediately post-intervention.

Eligibility criteria: Inclusion Criteria :

1. participants aged ≥18 years or older
2. participant diagnosed with non-specific chronic lower back pain (\> 12 weeks)
3. Able to perform physical therapy excercise . Exclusion criteria : The study will exclude

1- pregnant women 2- lactating women for one or less than one year post-natal. 3- any certain medical conditions that could interfere with physical activity, including:

* uncontrolled diabetes
* cardiovascular problem
* orthopedic impairments
* balance problems. 4-serious spinal pathologies :
* infection
* fractures
* tumors
* inflammatory diseases like ankylosing spondylitis 5- neurological compromise,
* spinal nerve compromise
* cauda equina syndrome

Primary outcomes:
measure: The primary outcome is pain sensitivity
timeFrame: pre- and immediately post-intervention
Secondary outcomes:
measure: The secondary outcome is the pain intensity in the lower back
timeFrame: pre- and immediately post-intervention
Other outcomes:
Locations:
city: Bisha
country: Saudi Arabia
facility: King Abdullah Hospital in bisha
state: Assser
Study officials:
References: