louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02355782: OMS721 Compassionate Use in Patients With Thrombotic Microangiopathy
Official title: Provision of OMS721 to Patients With Thrombotic Microangiopathy Under Compassionate Use
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Thrombotic Microangiopathy
Keywords: TMA, aHUS, TTP, stem cell transplant-associated TMA
Lead sponsor: Medical University of Lodz
Sponsor class: OTHER
First posted: 2015-02-04
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: The purpose of this compassionate use study, for two patients with thrombotic microangiopathy, is to provide expanded access to patients who have participated in the clinical trial OMS721-TMA-001 and in whom improvement in their disease markers was observed while on treatment or to patients who could otherwise benefit from the treatment. This is a treatment protocol; not a research protocol.Therefore, only patients in study OMS721-TMA-001 deemed eligible by the investigator may participate.

Detailed description: The study is open-label, expanded access study to provide continued OMS721 treatment for compassionate use to patients who have participated in clinical trial OMS721-TMA-001. Patients will be eligible if markers of disease activity, such as platelet count, LDH, and haptoglobin, were observed to improve during the study or if the patients disease activity remained stable, but they could be treated with a higher dose that may be beneficial. Safety measures of adverse events and laboratory measures will be monitored. Markers of disease activity, pharmacokinetics and ex vivo pharmacodynamics will also be monitored.

Eligibility criteria: Inclusion Criteria:

* Have a diagnosis of thrombotic microangiopathy related to aHUS, TTP or stem cell transplant.
* Have completed treatment in clinical trial OMS721-TMA-001.
* Investigator determined that continued treatment with OMS721 could be beneficial.
* Aged 18 years or older.

Exclusion Criteria:

* Hypersensitivity to OMS721 or any excipients.
* Have a serious medical condition that increases the risk of OMS721 treatment to the patient.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Medical University of Lodz
name: Michal Nowicki, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04944082: Remdesivir- Ivermectin Combination Therapy in Severe Covid-19
Official title: Remdesivir Versus Remdesivir- Ivermectin Combination Therapy in Severe and Critically Ill Covid-19
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Covid19
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-06-29
Enrollment: 60
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: Recent study reported in vitro synergistic interaction between two FDA approved drugs, remdesivir (RDV) and ivermectin (IVM) resulting in enhanced antiviral activity against SARS-CoV-2, the causative pathogen of COVID-19. The aim of the current study is comparing the efficacy and safety of combining remdesivir and ivermectin versus using remdesivir alone in patients with severe COVID-19.


Eligibility criteria: Inclusion Criteria:

* Adult, hospitalized severe COVID-19 patients; both genders; given informed consent (COVID-19 infection confirmed by PCR, severe illness is defined as patients with SpO2 ≤94% on room air, including patients on supplemental oxygen).

Exclusion Criteria:

* patients under 18 years old, pregnant ladies, advanced renal diseases (cr. Clearance \< 30 ml/hr), raised liver enzymes\> 3 folds of normal, arrhythmia.

Primary outcomes:
measure: 1- Improvement in level of oxygenation
timeFrame: By arterial blood gas and non-invasive pulse oximeter at date of randomisation, after 1 hour then on daily bases in stable cases till time of patient discharge or death
measure: 2- Need for ventilator support
timeFrame: From date of randomisation to patient discharge from hospital or death.
measure: 3- Length of hospital stay
timeFrame: From date of randomisation to date of patient discharge from hospital or death.
measure: 4- Development of complication
timeFrame: From starting to the end of ivermectin therapy (0 to the end of 4th day)
measure: 5- Mortality
timeFrame: Through study completion, an average of 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Caly L, Druce JD, Catton MG, Jans DA, Wagstaff KM. The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro. Antiviral Res. 2020 Jun;178:104787. doi: 10.1016/j.antiviral.2020.104787. Epub 2020 Apr 3.
citation: Pizzorno A, Padey B, Dubois J, Julien T, Traversier A, Duliere V, Brun P, Lina B, Rosa-Calatrava M, Terrier O. In vitro evaluation of antiviral activity of single and combined repurposable drugs against SARS-CoV-2. Antiviral Res. 2020 Sep;181:104878. doi: 10.1016/j.antiviral.2020.104878. Epub 2020 Jul 15.
Clinical trial NCT06358482: Electric Toothbrush Efficacy in Preventing Dental Plaque Development
Official title: Electric Toothbrush Efficacy in Preventing Dental Plaque Development: A RCT Using QLF Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Plaque
Calculus, Dental
Lead sponsor: Universita degli Studi di Catania
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study will be the first to compared dental plaque quantitation between an oscillating-rotating electric toothbrush and a manual toothbrush with a new QLF technology.

Detailed description: This is a randomized controlled trial of 12-weeks duration designed to assess whether a new commercially available oscillating-rotating electric toothbrush can objectively improve dental plaque parameters obtained via light induced fluorescence (QLF) technology. The study will be conducted in a dental clinic in Italy

Eligibility criteria: Inclusion Criteria:

* healthy adult (aged 18-50 years)
* non-smokers
* without clinical signs of periodontitis with at least 10 natural anterior teeth in total (cuspid to cuspid and lower and upper jaw).

Exclusion Criteria:

* significant oral soft tissue pathology or any type of gingival overgrowth other than plaque-induced gingivitis,
* with fixed and removable orthodontic appliances or removable dentures,
* with any other medical condition that, in the opinion of the principal investigator, would jeopardize the participant's safety or diminish the validity of study results

Primary outcomes:
measure: fluorescence intensity of at least 30% (ΔR30)
timeFrame: 120 DAYS
measure: the fluorescence intensity of at least 120% (ΔR120)
timeFrame: 120 DAYS
Secondary outcomes:
measure: oral hygiene (SOH) scoring, The score can be from 0, 1, .. to 5. A SOH value of 0 indicates no plaque, and 5 is the maximum and stands for maximum plaque teeth coverage an is the worst state.
timeFrame: 120 DAYS
Other outcomes:
Locations:
city: Catania
country: Italy
facility: ADDENDO
Study officials:
References:
Clinical trial NCT02201082: Evaluation of the Timing of the Nebulization Related to the Physiotherapy Session
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2014-07-25
Enrollment: 15
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the optimal time for the nebulization depending on the respiratory physiotherapy session in cystic fibrosis patients.


Eligibility criteria: Inclusion Criteria:

* Stable cystic fibrosis patients older than 16 y.o.
* Pseudomonas aeruginosa colonization
* Hypersecretion

Exclusion Criteria:

* Kidney failure
* No pregnancy

Primary outcomes:
measure: Urinary excretion of amikacin
timeFrame: 24h after the nebulization
Secondary outcomes:
measure: Amikacin concentration into the sputum
timeFrame: At the end of the nebulization, an expected average of 20 minutes
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
Study officials:
References:
Clinical trial NCT00724282: Treatment of Insomnia and Glucose Metabolism
Official title: Double-blind Placebo-controlled Study of the Effects of Eszopiclone on Glucose Tolerance, Insulin Secretion, and Insulin Action in Adults With Chronic Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sleep
Insomnia
Insulin Resistance
Keywords: sleep
eszopiclone
insulin secretion
insulin action
glucose tolerance
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2008-07-29
Enrollment: 20
Sex: ALL
Minimum age (years): 35
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Available data suggest that obtaining adequate sleep is associated with a better ability of the body to use carbohydrates as a source of energy and a lower risk of developing diabetes. The sleeping pill, Eszopiclone (Lunesta), has been approved by the Food and Drug Administration for the treatment of people who complain of trouble falling or staying asleep. This study will examine the hypothesis that the use of Eszopiclone (Lunesta) to improve the sleep of people with insomnia may also improve the use of sugar in their body.

Detailed description: Study participants will complete a set of oral and intravenous glucose (sugar) tolerance tests, which will be performed on two separate occasions in random order: once after a week of treatment with Eszopiclone (Lunesta) and once again after a week of receiving placebo.

Eligibility criteria: Inclusion Criteria:

* age between 35 and 64
* must have long-standing trouble falling or staying asleep
* BMI between 22 and 34 kg/m2

Exclusion Criteria:

* sleep apnea or other sleep disorder other than insomnia
* diagnosis of diabetes requiring treatment with pills or insulin
* smoking
* night or shift work
* presence of a medical condition that can disrupt sleep
* women only: irregular menstrual periods or pregnancy
* use of medications/compounds that can disrupt sleep

Primary outcomes:
measure: Plasma Glucose Level at the 120-minute Time Point of a 75g Oral Glucose Tolerance Test
timeFrame: at the end of each treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Plamen D Penev, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04333082: Refractory Status Epilepticus Treatment: Quality and Efficacy of Coma Induction
Official title: Refractory Status Epilepticus Treatment (RESET): Quality and Efficacy of Coma Induction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Status Epilepticus
Refractory Status Epilepticus
Keywords: artificial deep coma
intravenous anesthetic drugs (IVADs)
total seizure oppression
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2020-04-03
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients (i.e., patients ≥18 years of age) with diagnosed SE between 2005 and 2019 who have been treated at intensive care units (ICUs) of the University Hospital of Basel, a Swiss tertiary academic medical care center

Brief summary: This study is to investigate the effects of different treatment characteristics regarding the use of intravenous anesthetic drugs (IVADs) as a rescue treatment for refractory Status epilepticus (RSE) on course and outcome. A retrospective data extraction from the digital medical records, the electroencephalographic and microbiologic database of all consecutive adult patients with Status epilepticus (SE) admitted to the University Hospital Basel is undertaken.


Eligibility criteria: Inclusion Criteria:

* diagnosed SE between 2005 and 2019 who have been treated at intensive care units (ICUs) of the University Hospital of Basel

Exclusion Criteria:

* Patients with repetitive epileptic seizures not qualifying for SE or RSE
* Patients with documented refusal of the general in-house consent

Primary outcomes:
measure: number of in- hospital death
timeFrame: at baseline (T0)
Secondary outcomes:
measure: neurofunctional alteration assessed by Glasgow Outcome Score (GOS)
timeFrame: at baseline (T0)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Clinic for Intensive Care Medicine, University Hospital Basel
Study officials:
affiliation: Universitätsspital Basel / Intensivmedizin
name: Raoul Sutter, PD Dr. med
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fisch U, Junger AL, Baumann SM, Semmlack S, De Marchis GM, Hunziker S, Ruegg S, Marsch S, Sutter R. Association Between Induced Burst Suppression and Clinical Outcomes in Patients With Refractory Status Epilepticus: A 9-Year Cohort Study. Neurology. 2023 May 9;100(19):e1955-e1966. doi: 10.1212/WNL.0000000000207129. Epub 2023 Mar 8.
Clinical trial NCT02854982: Impact on Quality of Life 3 Years After Diagnosis of Prostate Cancer
Official title: Impact on Quality of Life 3 Years After Diagnosis of Prostate Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Neoplasms
Quality of Life
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2016-08-04
Enrollment: 900
Sex: MALE
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Target population: incident cases of prostate cancer

Brief summary: To study the quality of life of patients with prostate cancer at a distance from their care at a time when they are supposed to have taken a "normal" life and compared to subjects without cancer prostate of the same age.


Eligibility criteria: - exposed group

Inclusion Criteria:

* prostate cancer diagnosed from 1 December 2011 to 31 December 2014
* under 75 and residing in the Hérault department at diagnosis
* recruited in the EPICAP study

Exclusion criteria:

* having relapsed in the range
* non-exposed group:

Inclusion Criteria:

* controls (without prostate cancer) recruited in the EPICAP study
* matched to cases on age (5 years)
* residing in the Hérault department

Exclusion criteria:

* diagnosis of prostate cancer set in the range

Primary outcomes:
measure: EORTC Quality of Life Questionnaire - Core 30 Score (EORTC QLQ-C30 Score)
timeFrame: 3 years from diagnosis for cases of prostate cancer and from recruitment for controls
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Houede N, Rebillard X, Bouvet S, Kabani S, Fabbro-Peray P, Tretarre B, Menegaux F. Impact on quality of life 3 years after diagnosis of prostate cancer patients below 75 at diagnosis: an observational case-control study. BMC Cancer. 2020 Aug 12;20(1):757. doi: 10.1186/s12885-020-07244-y.
Clinical trial NCT04437082: Performance Evaluation of OCT and OCT Angiography-based Ocular Measurements (Optical Coherence Tomography)
Official title: Performance Evaluation of OCT and OCTA-based Ocular Measurements
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Normal Eyes and Ocular Pathology
Lead sponsor: Optovue
Sponsor class: INDUSTRY
First posted: 2020-06-18
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Seeing eye doctor for routine or follow-up care

Brief summary: The purpose of this study is to assess performance of measurements of anatomical and vascular structures of the eye based on OCT and OCTA scans in normal subjects and eyes with pathology.


Eligibility criteria: Inclusion Criteria:

* Normal - No pre-existing conditions.
* Glaucoma - Diagnosis of glaucoma.
* Retina - Diagnosis of retinal pathology
* Cornea - Diagnosis of clinic condition.

Exclusion Criteria:

- Unable to complete required exams.

Primary outcomes:
measure: Standard Deviation
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Tahlequah
country: United States
facility: Oklahoma College of Optometry, Northeastern State University
state: Oklahoma
Study officials:
References:
Clinical trial NCT06572982: Extension Study, Pilot, Compassionate Use of Azacitidine 300 Mg Film Coated Tablets for Acute Myeloid Leukaemia (AML) Patients
Official title: Extension Study, Pilot, Single-arm, Compassionate Use of Hikma Azacitidine 300 Mg Film Coated Tablets Test Product for the Acute Myeloid Leukaemia (AML) Patients Who Completed Hikma Bioequivalence Study with Protocol Number: HIK-AZA-2023-01
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Myeloid Leukemia
Keywords: oral azacitidine
azacitidine
Acute Myeloid Leukaemia
Lead sponsor: Hikma Pharmaceuticals LLC
Sponsor class: INDUSTRY
First posted: 2024-08-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Extension study, pilot, single-arm, compassionate use of Hikma Azacitidine 300 mg Film coated tablets test product for the Acute Myeloid Leukaemia (AML) patients who completed Hikma bioequivalence study with protocol number: HIK-AZA-2023-01


Eligibility criteria: Inclusion Criteria:

1. Patients with AML who completed Hikma bioequivalence study of the same Hikma generic oral Azacitidine test product with protocol number: HIK-AZA-2023-01, and who consent to participate in the study.
2. Patients who understand and voluntarily sign a written informed consent document prior to any study related assessment/procedures are conducted.

Exclusion Criteria:

1. Female patients who are pregnant or nursing (lactating).
2. Patients with medical condition, laboratory abnormality, or psychiatric illness that, in the opinion of the investigator, might interfere with subject safety, compliance or evaluation of the condition of the study.
3. Patients with experience in any investigational drug in a clinical study within 6 months prior to study (except for patients who were enrolled in the Hikma Azacitidine bioequivalence study with protocol number: HIK-AZA-2023-01).

Primary outcomes:
measure: Descriptive statistics for the type, frequency, severity, expectedness, seriousness, outcome and relationship of adverse events to study drug
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06090682: Effect and Mechanism of Brain Stimulation for Parkinson's Disease With Cognitive Impairment
Official title: Effect and Mechanism of Deep Brain Stimulation and Transcranial Magnetic Stimulation on Parkinson's Disease With Cognitive Impairment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson Disease
Cognitive Impairment
Keywords: Parkinson Disease
Cognitive Impairment
Deep brain stimulation
Transcranial magnetic stimulation
Lead sponsor: Tianjin Huanhu Hospital
Sponsor class: OTHER
First posted: 2023-10-19
Enrollment: 200
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Recruiting 200 patients with primary Parkinson's disease, aged less than 75 years old, regardless of gender, without prior brain injury, and with a history of brain surgery

Brief summary: This study intends to apply structural and functional brain network neuroimaging techniques combined with image post-processing methods to explore the differences in brain network changes in PD patients with cognitive impairment after DBS or TMS.

Detailed description: A variety of post-processing methods (VBM, SPM, CAT, LEAD-DBS, etc.) were used to analyze structural brain network images (sMRI, DTI) and functional brain network images (rs-fMRI, PET) based on connectomics, and combined with the changes of clinical symptoms before and after treatment. To study the mechanism of the influence of neural regulation on brain network, and further analyze how DBS and TMS improve the cognitive symptoms of PD patients from the perspective of brain connectomics, so as to explore the occurrence and development of Parkinson's disease with cognitive impairment and the possible improvement mechanism.According to the individual differences in clinical symptoms of different PD patients, better stimulation sites and the best brain network are sought to further guide the surgical plan, so as to obtain the best clinical treatment effect.

Eligibility criteria: Inclusion Criteria:

1. The clinical diagnosis of PD is consistent with the United Kingdom Parkinson's Disease Society Brain Bank criteria, with disease duration over 5 years, acute levodopa motor response ≥30%, and indication for STN-DBS.

Exclusion Criteria:

Exclusion criteria included patients with severe cognitive impairment, severe psychiatric disorders, acute levodopa motor response less than 30%, atypical parkinsonism, and contraindications to surgery.

Primary outcomes:
measure: Montreal Cognitive Rating Scale(MoCA)
timeFrame: December 2023 to December 2026
measure: verbal fluency test (VF)
timeFrame: December 2023 to December 2026
Secondary outcomes:
measure: the third part of the Unified Parkinson's Disease Rating Scale (UPDRS III)
timeFrame: December 2023 to December 2026
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Huanhu Hospital
state: Tianjin
Study officials:
References: