louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00175864: Open Label Study (Everyone Who Participates Receives Drug) to Further Determine How Safe and Effective Oral Treatment of Seletracetam is in Patients With Refractory Epilepsy.
Official title: Open Label, Multicenter Study of the Safety and Efficacy of Oral Treatment With Immediate Release Seletracetam (Ucb 44212) at Individualized Doses up to a Maximum of 160mg/Day in Refractory Epileptic Patients.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Epilepsy
Keywords: Partial Onset, Primary Generalized Seizures, Seletracetam
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 0
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a safety and efficacy study of add on therapy with seletracetam in patients experiencing refractory epilepsy.


Eligibility criteria: Inclusion Criteria:

* An IRB/IEC approved written informed consent form signed and dated Male/Female patients age 18 (or 16 years where permitted by law) to 65.
* Minimum body weight of 40 kg.
* Patients with a confirmed diagnosis of refractory epilepsy of ≥ 6 months.
* Patients must be receiving 1 - 3 concomitant AEDs.
* Female patients without childbearing potentials (2 years post-menopausal or surgical sterilization) are eligible. Female patients with childbearing potential are eligible if they use a medically accepted non-hormonal contraceptive method.

Exclusion Criteria:

* Seizures occurring in clusters (seizures occurring either too frequently or indistinctly separated to be reliably counted).
* Status epilepticus within 3 months of Visit 1.
* History of non-epileptic seizures.
* Patients on vigabatrin.
* Patients on felbamate, unless treatment has been continuous for ≥ 18 months.
* Use of benzodiazepines (for any indication) taken at a higher frequency than an average of once a week, unless counted as one of the concomitant AEDs.
* Ongoing psychiatric disease other than mild controlled disorders.
* Patients with a clinically significant organ dysfunction.
* Known allergic reaction or intolerance to pyrrolidine derivatives and/or excipients.
* Pregnant or lactating women. Any woman with childbearing potential who is not using a medically accepted, non-hormonal method of birth control.

Primary outcomes:
measure: Safety profile of seletracetam
Secondary outcomes:
measure: Reduction in seizure frequency
Other outcomes:
Locations:
Study officials:
affiliation: UCB Pharma
name: Barbara Bennett, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01343264: Trimodality Therapy for Malignant Pleural Mesothelioma
Official title: Trimodality Therapy for Malignant Pleural Mesothelioma: Radical Pleurectomy, Followed by Adjuvant Chemotherapy With Cisplatin/Pemetrexed and Radiotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Malignant Pleural Mesothelioma
Keywords: Radical Pleurectomy
Pleurectomy/decortication
Cisplatin
Pemetrexed
Radiation
Lead sponsor: HSK Wiesbaden
Sponsor class: OTHER
First posted: 2011-04-28
Enrollment: 200
Sex: ALL
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: Patients with malignant pleural mesothelioma prsentint at the Deparment of Thoracic Surgery, HSK Wiesbaden

Brief summary: The role of surgical resection in the management of Malignant Pleural Mesothelioma (MPM) is still controversial. The selection criterion to perform either Extrapleural Pneumonectomy (EPP) or Pleurectomy/Decortication (P/D) is dependent not only on the cardio-pulmonary status of the patient, tumor stage and intraoperative findings but also on surgeons' decision and philosophy. There are no established guidelines. Radical Pleurectomy (RP) competes against EPP as surgical therapy modality. Both surgical approaches are cytoreductive treatment options. The aim is to remove all gross disease and to achieve macroscopic complete resection.

Originally P/D was a palliative option for controlling pleural effusion. But lung-sparing surgery for MPM seems to be an alternative to patients unsuitable or unwilling to undergo EPP in a multimodality therapy concept. Most studies evaluating multimodality therapies for MPM are based on retrospective analyses and their interpretation is difficult because of inhomogeneous patient groups studied.

The aim of our study was to analyze the feasibility and results of RP as surgical therapy modality in a standardized trimodality therapy concept.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed diagnosis of MPM (all subtypes)
* Clinical T1-3, N0-2, M0 disease.
* No prior treatment for MPM.
* Adequate renal and liver function
* Adequate cardio-pulmonary reserves

Exclusion Criteria:

* Patients with unresectable disease
* Patients with an active infection that require systemic treatments
* Patients with a concurrent active malignancy.
* Patients with serious medical illness.

Primary outcomes:
measure: To determine the overall 5-year survival rate.
timeFrame: 5-years
Secondary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 3 months
measure: Number of Participants with treatment related deaths as a Measure of Safety and Tolerability
timeFrame: 3 months
measure: Recurrence
timeFrame: 5 years
Other outcomes:
Locations:
city: Wiesbaden
country: Germany
facility: Dr. Horst Schmidt Klinik, Department of Thoracic Surgery
Study officials:
affiliation: HSK Wiesbaden
name: Joachim Schirren, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00825864: Diclofenac vs Dexamethasone in Combined Surgery
Official title: Evaluation the Effect of Diclofenac Drops vs Dexamethasone Drops in Trabeculectomy and Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Cataract
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-01-21
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study the effect of Diclofenac drops or Dexamethasone drops on combined surgery of trabeculectomy and cataract surgery.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for combines surgery of trabeculectomy and cataract surgery

Exclusion Criteria:

* severe complicated surgery like vitreal loss, expulsive hemorrhage, endophthalmitis

Primary outcomes:
measure: intraocular pressure
timeFrame: year
Secondary outcomes:
measure: the number of antiglaucoma medications
timeFrame: year
Other outcomes:
Locations:
city: Tel-Hashomer
country: Israel
facility: Goldschleger Eye Institute, Sheba Medcial Center
Study officials:
affiliation: Tel-Aviv University, Israel
name: Hani Levkovitch-Verbin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06003764: Efficacy of Pulsed Electromagnetic Field Therapy on Acute Radiodermatitis in Breast Cancer Patients
Official title: Efficacy of Pulsed Electromagnetic Field Therapy on Acute Radiodermatitis in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dermatitis, Radiation Induced
Keywords: PEMFT, DERMATITIS, RADIOTHERAPY
Lead sponsor: Ahram Canadian University
Sponsor class: OTHER
First posted: 2023-08-22
Enrollment: 50
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, single blinded controlled trial
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the impact of PEMF on acute radiodermatitis in breast cancer patient and post mastectomy patients.

Detailed description: The objective is to understand the effect of PEMF on skin thickness and toxicity after radiotherapy on breast cancer.

The study included 50 adult female breast cancer undergoing whole-breast irradiation.

This is a randomized, controlled clinical trial was conducted at the outpatient clinic of the Faculty of Physical Therapy, Ahram Canadian University, Egypt.

Eligibility criteria: Inclusion Criteria:

* Breast cancer patients undergoing HF-WBI post-lumpectomy with or without chemotherapy.
* Unilateral breast cancer
* Age from 35-55 years.

Exclusion Criteria:

* Patients had previous irradiation to the same breast.
* Patients had bilateral breast cancer.
* Patients had metastatic disease.
* when the use of bolus material was required to deliver RT.
* Patients had a pre-existing skin condition or open wound in the treatment area.

Primary outcomes:
measure: Ultrasonography skin thickness measurement.
timeFrame: pre treatment, every two weeks of treatment( total weeks 8 weeks) of treatment for up to 2 months total time.
Secondary outcomes:
measure: Radiation Therapy Oncology Group (RTOG) SCALE
timeFrame: pre treatment, every two weeks of treatment( total weeks 8 weeks) of treatment for up to 2 months total time.
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: ahram canadian University
Study officials:
References:
Clinical trial NCT04796064: Low Versus High-Intensity Aerobic Training in Community-dwelling Older Men With Post-COVID 19 (SARS-CoV-2) Sarcopenia
Official title: Comparative Effectiveness Study of Low Versus High-Intensity Aerobic Training in Community-dwelling Older Men With Post-COVID 19 Sarcopenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-03-12
Enrollment: 76
Sex: MALE
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sarcopenia is the major health concern and common consequence of COVID-19 in the ageing population. The objective of this study is to find and compare low and high-intensity aerobic training protocols on clinical and psychological effects in community-dwelling older men with post-COVID 19 Sarcopenia.


Eligibility criteria: Inclusion Criteria:

* Age range of 60 - 80 years with
* A positive diagnosis of post-COVID-19 sarcopenia

Exclusion Criteria:

* Under medication
* History of lower limb surgeries, fractures
* Cardiac problems
* Respiratory problems
* Neurological problems
* Systemic problems and any other contraindications for aerobic training

Primary outcomes:
measure: Handgrip strength
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Marwa Eid
Study officials:
References:
Clinical trial NCT06220864: SNV1521 in Participants with Advanced Solid Tumors
Official title: A Phase 1, Open-Label Dose Escalation and Expansion Study of SNV1521 in Participants with Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumor
Lead sponsor: Synnovation Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-01-24
Enrollment: 200
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 study is testing a new medicine, SNV1521, for people with advanced cancers. The researchers want to find out if SNV1521 is safe, well-tolerated, and effective in treating solid tumors. They are investigating different doses in order to find the most effective and safe one. They are also investigating whether it can be combined with other cancer therapies.


Eligibility criteria: Inclusion Criteria:

* Advanced or metastatic solid tumor malignancy
* Evaluable or Measurable disease (RECIST 1.1 Criteria).
* ECOG Performance Status 0 or 1.
* Life expectancy \> 3 months

Exclusion Criteria:

* History of other malignancy within the past 2 years
* Prior diagnosis of Myelodysplastic syndrome or Acute Myeloid Leukemia
* Significant cardiovascular disease within 6 months
* Significant gastrointestinal disease
* HIV infection with a CD4+ T-cell count \< 200 cells/μL and/or a detectable viral load
* Liver dysfunction

Primary outcomes:
measure: Safety of SNV1521
timeFrame: From first dose through last dose (up to 13 months)
measure: Tolerability of SNV1521
timeFrame: DLTs: From first dose through completion of first cycle (28 days)
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Houston
country: United States
facility: The University of Texas M.D. Anderson Cancer Center
state: Texas
city: West Valley City
country: United States
facility: START Center for Cancer Care
state: Utah
city: Randwick
country: Australia
facility: Scientia Clinical Research
state: New South Wales
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Crawley
country: Australia
facility: Linear Clinical Research
state: Western Australia
Study officials:
References:
Clinical trial NCT02173964: Pinverin Application Trial to Reduce Bowel Uptake of FDG (Fluorodeoxyglucose)
Official title: Clinical Trial of Pinverin (Pinaverium Bromide) to Reduce Bowel Uptake of FDG in a Variety of Cancer Patients Who Undergo FDG PET/CT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cancer
Keywords: fluorodeoxyglucose
positron emission tomography
computed tomography
bowel
pinaverium bromide
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-06-25
Enrollment: 58
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 1. Background

   1. PET/CT (positron emission tomography/computed tomography) using FDG (fluorodeoxyglucose) is widely used for evaluation of cancer patients.
   2. Bowel uptake of FDG is a serious problem that hampers the proper reading of PET/CT.
   3. There is no widely-accepted method to reduce the bowel FDG uptake.
2. Purpose

   1. To know whether pinverin (pinaverium bromide) application during PET/CT can reduce bowel uptake of FDG.
   2. Pinverin is a calcium-channel blocker that ameliorates the bowel contraction.
   3. Pinverin may be useful to reduce bowel FDG uptake by ameliorating the bowel contraction during PET/CT acquisition.
3. Method

   1. Intervention versus control: administration of single tablet of pinverin (50mg) perorally versus simple water (\~100mL).
   2. Timing of administration: At the time of FDG injection. PET/CT images will be acquired 1hr post FDG injection.
4. Primary outcome

   1. SUV (standardized uptake value) difference between pinverin administered patient group versus control group.
   2. SUV (standardized uptake value) is calculated as: (decay corrected radioactivity in mCi/mL) x (body weight in g) / (injected radioactivity in mCi)


Eligibility criteria: Inclusion Criteria:

* Any cancer patients
* Candidate of positron emission tomography/computed tomography

Exclusion Criteria:

* Diabetes mellitus
* Inflammatory bowel disease
* Irritable bowel syndrome
* Peritoneal carcinomatosis
* Peritonitis
* Abdominal pain
* Diarrhea
* Medical test requiring bowel preparation within 1 month
* History of abdominal surgery
* Symptom or sign of colitis
* Pregnancy or lactation
* Hypersensitivity to pinaverium bromide
* Lactate intolerance
* Anit-depressant medication

Primary outcomes:
measure: SUV (standardized uptake value)
timeFrame: 1 hour after FDG (the radiopharmaceutical for PET/CT) injection
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Won Woo Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04308564: Laboratory and Clinical Data in Antiphospholipid Patients
Official title: Constitution d'Une Collection d'Echantillons Biologiques Associee a Une Base de Donnees de Patients Possedant Des Anticorps Antiphospholipides
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Antiphospholipid Syndrome
Keywords: antiphospholipid antibodies
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-03-16
Enrollment: 60
Sex: ALL
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: Antiphospholipid antibodies positive-patients

Brief summary: To constitute a registry of antiphospholipid antibodies positive-patients

Detailed description: An international web-based application, the REDCap (Research Electronic Data Capture), captures data on patient demographics, aPL-related clinical and laboratory characteristics, and medications. The inclusion criteria are: a) age between 18 and 60 years; and b) persistent (at least 12 weeks apart) aPL-positivity within 12 months prior to screening; positivity is defined as anticardiolipin antibodies (aCL) IgG/M/A (\> 40 GPL/MPL/APL, medium-to-high titer, and/or greater than the 99th percentile), anti-β2-glycoprotein-I (aβ2GPI) IgG/M/A (\> 40 units, medium-to-high titer), positive lupus anticoagulant (LA) test based on International Society on Thrombosis and Hemostasis and other current guidelines. Patients are followed every 12 ± 3 months with clinical data and blood collection. Blood drawn is done at inclusion and every year.

Eligibility criteria: Inclusion Criteria:

* age between 18 and 60 years;
* persistent (at least 12 weeks apart) aPL-positivity within 12 months prior to screening

Exclusion Criteria:

* no inform consent
* impossible follow up
* pregnancy

Primary outcomes:
measure: Thrombosis
timeFrame: Up to 10 years
Secondary outcomes:
measure: Bleeding
timeFrame: Up to 10 years
Other outcomes:
Locations:
city: Lille
country: France
facility: CHRU de Lille
city: Nancy
country: France
facility: CHRU de Nancy
Study officials:
References:
Clinical trial NCT05557864: Effects of Pallidal Deep Brain Stimulation Location on Motor Impairment in Parkinson's Disease
Official title: Effects of Pallidal Deep Brain Stimulation Location on Motor Impairment in Parkinson's Disease; Udall Project 2 Aims 1 & 2
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson's Disease
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2022-09-28
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This protocol will characterize the effects of deep brain stimulation (DBS) location (both adverse and beneficial) on motor signs in people with Parkinson's disease (PD). This information can be used to inform future DBS protocols to tailor stimulation to the specific needs of a patient. If targeted dorsal GP stimulation is shown to significantly improve motor features that are typically resistant to dopamine replacement therapy, these experiments will likely have major impact on clinical practice by providing a potential strategy to these medically intractable symptoms.


Eligibility criteria: Inclusion Criteria:

* diagnosis of idiopathic PD
* have undergone neurosurgery to implant deep brain stimulators in the globus pallidus (GP DBS) or subthalamic nucleus (STN)
* Existing 7T brain imagery

Exclusion Criteria:

* history of musculoskeletal disorders that significantly affect movement of the upper or lower limbs
* other significant neurological disorder
* history of dementia or cognitive impairment as found with UBACC (or MacCAT-CR)
* post-operative complications or adverse effects

Primary outcomes:
measure: Changes in the combined elastic, viscous and inertial resistance across conditions will be assessed by integrating the resistive torque
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University Of Minnesota
state: Minnesota
Study officials:
References:
Clinical trial NCT04343690: COPING With COVID-19( CWC-19)
Official title: Effectiveness of Crisis Management Coaching on Faculty and Trainee Wellness During COVID-19 Crisis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: COVID-19
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2020-04-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is 1) to understand effects of COVID-19 crisis on wellness of pulmonary and critical care faculty and trainees who are at frontline fighting this pandemic 2) Assess the effectiveness of series of weekly web based crisis management coaching from world renowned experts in coaching and 3) identify future areas of opportunities in physician wellness


Eligibility criteria: Inclusion Criteria:

* Any faculty, staff, or trainee from Duke pulmonary and critical care that consents to being in the study

Exclusion Criteria:

-

Primary outcomes:
measure: Change in stress level as measured by survey
timeFrame: Baseline, mid-session (up to 4 weeks), post-intervention (up to 8 weeks)
Secondary outcomes:
measure: Change wellness as measured by survey
timeFrame: Baseline, mid-session (up to 4 weeks), post-intervention (up to 8 weeks)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Patty Lee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Sangeeta Joshi, MD
role: PRINCIPAL_INVESTIGATOR
References: