louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03847441: Topical Calcipotriol Versus Narrowband Ultraviolet B in Treatment of Alopecia Areata
Official title: Topical Calcipotriol Versus Narrowband Ultraviolet B in Treatment of Alopecia Areata: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alopecia Areata
Keywords: Alopecia Areata
Calcipotriol
Narrow Band-UVB
Vitamin D3
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2019-02-20
Enrollment: 60
Sex: ALL
Minimum age (years): 14
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Alopecia Areata is a common condition. This study investigated the efficacy of calcipotriol versus Narrow Band Ultraviolet B in treatment of Alopecia areata and their effects on serum vitamin D3 levels.


Eligibility criteria: Inclusion Criteria:

* Alopecia Areata of scalp

Exclusion Criteria:

Other causes of alopecias including scarring alopecia, androgenic alopecia, telogen effluvium autoimmune diseases, pregnant and lactating females

Primary outcomes:
measure: Clinical improvement of Alopecia Areata After treatment As assessed by Severity of Alopecia tool (SALT) score
timeFrame: 3 months
measure: Improvement of serum Vitamin D levels in (ng/ml) after treatment
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University Hospital
Study officials:
References:
Clinical trial NCT00380341: Effects of Instrument-Applied Spinal Manipulative Therapy on Postureal Control and Autonomic Balance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Rate
Lead sponsor: Logan College of Chiropractic
Sponsor class: OTHER
First posted: 2006-09-25
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effects of spinal manipulative therapy on autonomic balance and to determine if there exists a relationship between autonomic state and postural control.

Detailed description: Previous studies have demonstrated that sensory and cognitive systems share some common neural substrate. The afferent neural impuleses of mechanoreception (also known as somatosensation) as produced by joint mechanoreceptors and adjacent muscle spindle cells may impact supraspinal centers. Few studies have been done to determine if the afferent impulses generated by spinal manipulative therapy (SMT) can impact the porcessing that occurs at supra-spinal centers. The relationship between postural control and cognition is studies using a dual-tak methodology, a primary (postural) task will often demonstrate degradation with the addition of a secondary, concurrent (cognitive) task. The current study seeks to determine the effects of SMT on postrual control using a dual-task paradigm, while monitoring autonomic state (using Heart Rate Variability analysis) during the course of therapy. It is thought that SMT can improve HRV status, and postural control within a dual-task situation, and that there will be differences in postural control related to a participant's HRV status. Activities of daily living often invole the coupling of a cognitive task with a complex postural task.

Eligibility criteria: Inclusion Criteria:

* Healthy adults currently enrolled at Logan College

Exclusion Criteria:

* Lower extremity injury, vestibular disorders

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Logan College of Chiropractic
name: Kristan J. Giggey, DC
role: PRINCIPAL_INVESTIGATOR
affiliation: Logan College of Chiropractic
name: Rodger Tepe, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06339541: The ACC Preclinical Research Platform for Precision Oncology
Official title: La Piattaforma ACC di Ricerca Preclinica Per l'Oncologia di Precisione
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Solid Tumor
Hematologic Neoplasms
Lead sponsor: Fondazione del Piemonte per l'Oncologia
Sponsor class: OTHER
Collaborators: name: Alleanza Contro il Cancro
First posted: 2024-04-01
Enrollment: 250
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients, including paediatric patients, with solid and haematological malignancies for whom tissue or tumour cell material is available.

Brief summary: The ACC Preclinical Research Platform for Precision Oncology is a retrospective and prospective observational study focused on the implementation and validation of the application of PDCM (Patient Derived Cancer Models) generated from tissues or cells of patients with neoplastic disease, as a tool to improve molecular and biological knowledge of tumours and to test the efficacy and sensitivity of pharmacological treatments.

Detailed description: This is a retrospective and prospective observational study, focused on the implementation and validation of the application of PDCM, generated from tissue or cells of patients, including paediatric patients, with solid and haematological malignancies, as a tool to improve molecular and biological knowledge of tumours and to test the efficacy and sensitivity of pharmacological treatments.

An up-to-date database of all PDCMs available at the participating italian hospitals will be generated and enriched with new models generated during the course of the project. The sharing of models and procedures between the different hospitals will facilitate their molecular and phenotypic characterisation, also in parallel with the tumours of origin, as well as their validation as tools for testing the efficacy of drugs for precision medicine. By establishing common workflows and standards and performing cross-validation experiments it is planned to build a network of reference centres as a resource for drug screening on 2D and 3D models.

Eligibility criteria: Inclusion Criteria:

* Patients, including paediatric patients, with solid and haematological malignancies for whom tissue or tumour cell material is available.

Exclusion Criteria:

* none

Primary outcomes:
measure: number of PDCM (patient derived cancer models)
timeFrame: 12 months
measure: number of Whole Exome Sequencing (WES) e RNA-seq performed
timeFrame: 12 months
Secondary outcomes:
measure: number of PDCM shared within the network
timeFrame: 12 months
Other outcomes:
Locations:
city: Candiolo
country: Italy
facility: Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo
state: Turin
Study officials:
affiliation: Fondazione del Piemonte per l'Oncologia
name: Enzo Medico, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04906941: Assessment of the Impact of Gadolinium Injection on the Measurement of the QSM Signal
Official title: Assessment of the Impact of Gadolinium Injection on the Measurement of the QSM Signal
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: White Matter Disease
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2021-05-28
Enrollment: 50
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 meeting the inclusion and non-inclusion criteria will be offered to participate in the study. If they agree, they will perform an MRI without injection to obtain the QSM then perform the MRI with injection that was prescribed to them as part of the care, then they will perform a second time the MRI without injection to obtain the QSM. They will also answer a short questionnaire documenting their previous exposure to gadolinium.

Brief summary: Patients meeting the inclusion and non-inclusion criteria will be offered to participate in the study. If they agree, they will perform an MRI without injection to obtain the QSM then perform the MRI with injection that was prescribed to them as part of the care, then they will perform a second time the MRI without injection to obtain the QSM. They will also answer a short questionnaire documenting their previous exposure to gadolinium.

Detailed description: Patients meeting the inclusion and non-inclusion criteria will be offered to participate in the study. If they agree, they will perform an MRI without injection to obtain the QSM then perform the MRI with injection that was prescribed to them as part of the care, then they will perform a second time the MRI without injection to obtain the QSM. They will also answer a short questionnaire documenting their previous exposure to gadolinium.

Eligibility criteria: Inclusion Criteria:

* patients over 18 years old
* with an inflammatory CNS pathology
* to benefit as part of care from an MRI with injection of gadolinium
* consent to participate in the study
* beneficiary of a social protection scheme

Exclusion Criteria:

* pregnant or breastfeeding woman
* patient benefiting from a legal protection measure
* Patient having performed more than 3 MRI exams with gadolinium injection during his life

Secondary exclusion criteria :

* motion artifact not allowing image interpretation
* patient who has not completed one of the following sequences: T1 anatomical, FLAIR, or QSM pre-gadolinium injection.

Secondarily excluded patients will be replaced up to a maximum of 25 patients.

Primary outcomes:
measure: mean of the delta observed between the QSM of the white matter before and after injection of gadolinium
timeFrame: 1 DAY
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hhopital fondation adolphe de rothschild
Study officials:
References:
Clinical trial NCT04588441: The ARCTIC Trial: Aerosolized Inhaled Adenosine Treatment in Patients With Acute Respiratory Distress Syndrome (ARDS) Caused by COVID-19
Official title: Aerosolized Inhaled Adenosine Treatment in Patients With Acute Respiratory Distress Syndrome (ARDS) Caused by COVID-19 (The ARCTIC Trial)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Acute Respiratory Distress
Keywords: COVID-19
ARDS
Adenosine
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Testing will be applied to patients with deteriorating pulmonary function and who are newly intubated (within 24 hours) with rising oxygen requirements.
Primary purpose: TREATMENT

Brief summary: This is a phase II study to test adenosine efficacy for down-regulation of the overwhelming inflammation of COVID-19 in the lungs as reflected by clinical recovery of lung function; resolution of clinically relevant markers of lung function, and resolution of systemic markers of inflammation and coagulation.


Eligibility criteria: Inclusion Criteria:

* Adult (≥ 18 years old) male and female patients with diagnosed COVID-19 respiratory infection, verified by culture/swab RNA. Impending ARDS respiratory collapse with progressive increasing oxygen requirements, and in line with sub-study as defined below.
* Patients intubated within the prior 24 hours.
* Hemodynamically stable (not requiring vasopressors or catecholamine agents to support systemic blood pressure; no existing shock defined as BP \< 100 mmHg systolic).
* In-place continuous arterial line for blood sampling.

Exclusion Criteria:

* Younger than 18 years old.
* Prisoners
* Pregnant women.
* Unable to obtain next of kin consent.
* End-stage cardiac disease with COVID-19.
* Non COVID-related causes of ARDS/respiratory failure, septic shock, or post trauma shock, respiratory failure after blood transfusion or surgery.
* Unstable asthma or history of frequent/poorly controlled asthmatic attacks.
* Not expected to live more than 6 months due to underlying condition such as cancer.

Primary outcomes:
measure: Improved COVID-19 symptoms
timeFrame: Day 50
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Florida
name: Bruce Spiess
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01590134: The Efficacy and Safety of Iron Supplementation
Official title: Pilot Studies on the Efficacy and Safety of Dietary Iron Supplementation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: volunteers
Pilot study
There are no pre registration evaluations.
Inclusion criteria: to be a healthy, consenting volunteer not currently receiving iron supplements.
Exclusion criteria: 1) Needle phobia; 2) Currently receiving iron supplements; 3) Unable to provide informed consent
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2012-05-02
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Each year, 5 million packs of iron tablets are dispensed in England and Wales to treat anaemia due to iron deficiency. Iron tablets are not always easy to take. The investigators think that there could be ways to reduce the number of iron tablets needed, by increasing the dietary intake of iron. In this study the investigators will assess the efficacy and safety of a dietary iron supplement compared to iron tablets using controls and new biomarkers.

Detailed description: 18 healthy individuals will be randomised to one of three arms, and for two consecutive mornings, will receive either an iron tablet (ferrous sulphate 200mg), a dietary iron supplement, or no agent.

Blood and urine samples will be collected pre-dose, and at stated intervals 2.5, 4, 7, 24 and 48 hours post first dose.

The standard deviations of data obtained in this pilot study will be used to perform power calculations for our future studies in this field.

Eligibility criteria: Inclusion Criteria:

To be a healthy, consenting volunteer not currently receiving iron supplements.

Exclusion Criteria:

1. Needle phobia
2. Currently receiving iron supplements
3. Unable to provide informed consent

Primary outcomes:
measure: Iron levels in blood tests
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Wellcome Trust-McMichael Clinical Research Facility, Imperial college London
Study officials:
affiliation: Imperial College London
name: Claire L Shovlin, PhD MA MB BChir FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Further analyses are in progress for full manuscript.
citation: Gilson C, Busbridge M, Shovlin CL, Iron tablet profiling. Hematology Reports 2013: 5 (s1),30-1
Clinical trial NCT04363034: Arkansas Expanded Access COVID-19 Convalescent Plasma Treatment Program
Official title: Arkansas Expanded Access COVID-19 Convalescent Plasma Treatment Program
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: COVID-19
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2020-04-27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: This is an expanded access treatment protocol to treat up to 100 patients with severe or life-threatening, laboratory confirmed COVID-19 with COVID-19 convalescent plasma.

Detailed description: This is an expanded access treatment protocol to treat up to 100 subjects with severe or life-threatening, laboratory confirmed COVID-19 with COVID-19 convalescent plasma. Subjects will receive 1-2 units (200-400 mL per unit, not to exceed 550 mL total) of ABO compatible, low isohemagglutinin titer, COVID-19 convalescent plasma. Plasma will be administered one unit per day for up to two days. The duration of infusion will usually take 1 to 2 hours (rate of 100 to 250 mL/hr). The infusion should not exceed 4 hours. Plasma infusions will be administered following standard institutional procedures, including the use of premedications (e.g. acetaminophen, diphenhydramine, etc.) as necessary.

Eligibility criteria: Inclusion Criteria:

* Male or Female
* 18 years of age or older
* Laboratory confirmed COVID-19 via SARS-CoV-2 RT-PCR testing
* Patients currently hospitalized with severe or life-threatening COVID-19 or patients the treating physician deems to be at high-risk for progressing to severe or life-threatening COVID-19.

  * Severe disease, defined as one or more of the following:

    * dyspnea,
    * respiratory frequency ≥ 30/min,
    * blood oxygen saturation ≤ 93%,
    * partial pressure of arterial oxygen to fraction of inspired oxygen ratio \< 300, and/or
    * lung infiltrates \> 50% within 24 to 48 hours
  * Life-threatening disease, defined as one or more of the following:

    * respiratory failure,
    * septic shock, and/or
    * multiple organ dysfunction or failure
* Patients or their legally authorized representative must provide informed consent.

Exclusion Criteria:

* Female patients with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period.
* Patients who have received pooled immunoglobulin in past 30 days
* Contraindication to transfusions or history of prior reactions to transfusion blood products

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00808834: Non-dispense Comfort Comparison of Two Silicone Hydrogel Lenses
Official title: Non-dispense Comfort Comparison of Two Silicone Hydrogel Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-12-16
Enrollment: 196
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare subjective responses to two contact lenses after 15 minutes of wear.


Eligibility criteria: Inclusion Criteria:

* Currently wearing soft contact lenses
* Replaces lenses on a weekly or longer schedule
* Other protocol-defined inclusion/exclusion criteria may apply

Exclusion Criteria:

* Requires concurrent ocular medication
* Eye injury or surgery within twelve weeks immediately prior to enrollment
* Currently wearing soft toric lens wearers
* Those who dispose of their soft lenses on a daily basis
* Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Comfort After Insertion
timeFrame: 30-60 seconds after initial insertion
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03735134: Colchicine in Periprocedural Myocardial Infarction: the Role of Alpha Defensin
Official title: Colchicine in Periprocedural Myocardial Infarction: the Role of Alpha Defensin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inflammation
Myocardial Infarction
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2018-11-08
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this research is to study the effect of a loading dose of colchicine on the occurrence of periprocedural myocardial infarction (PPMI) in elective percutaneous coronary intervention.


Eligibility criteria: Inclusion Criteria:

* Patients hospitalized with troponin negative events and scheduled for elective PCI

Exclusion Criteria:

* Significant renal dysfunction
* Significant liver dysfunction
* Severe left ventricular dysfunction
* Severe low weight
* Chronic colchicine treatment

Primary outcomes:
measure: Occurrence of PPMI post elective PCI
timeFrame: 24 hours post PCI
Secondary outcomes:
measure: Traditional inflammatory markers
timeFrame: 24 hours post PCI
measure: Major adverse cardiovascular events
timeFrame: 30 days
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hille Yaffe Medical Center
Study officials:
References:
Clinical trial NCT00638534: Japanese Study Evaluating the Effects of Telithromycin in Children With Acute Otitis Media
Official title: Evaluation of the Safety, Efficacy, Pharmacokinetics, and Acceptability of HMR3647 20 mg/kg qd for 5 Days With Acute Otitis Media (AOM) in Children (Multicenter, Open Label, Non Comparative Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Otitis Media
Keywords: Acute Otitis Media
AOM
children
Child
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-03-19
Enrollment: 56
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective is to assess the safety of telithromycin (HMR3647) 20 mg/kg qd for 5 days in children with acute otitis media (AOM).

Secondary objectives are to assess Efficacy, Pharmacokinetics and Acceptability of telithromycin 20 mg/kg qd for 5 days in children with AOM.


Eligibility criteria: Inclusion Criteria:

* Subjects who are weighing 40 kg or less. If female, premenarchal status is required.
* Subjects with signs of infection according to middle ear signs and general signs or symptoms such as otalgia, fever, sleep disturbance, irritability, inconsolability.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Safety evaluation: presence/absence of subjective/objective symptoms and abnormal laboratory findings
Secondary outcomes:
measure: Clinical efficacy: tympanic signs
measure: Acceptability: compliance and willingness to take medication
measure: Pharmacokinetics: plasma concentrations of telithromycin
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: CSD
role: STUDY_DIRECTOR
References: