louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04466527: Laser Treatment of Moderate to Severe Acne Vulgaris
Official title: Laser Treatment for the Clinical Improvement of Acne Vulgaris: A Self-Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Acne Vulgaris
Keywords: Acne
Acne Vulgaris
Laser
Cystic Acne
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2020-07-10
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study, we are enrolling subjects with moderate to severe acne vulgaris and investigating the use of a commercially available laser in treating acne.


Eligibility criteria: Inclusion Criteria:

1. Subject must be able and willing to provide written informed consent and comply with the requirements of the study protocol;
2. In good general health, based on answers provided during the screening visit;
3. Subject must be able to read and understand English;
4. Any gender and any Fitzpatrick skin type;
5. Ages 18 through 40;
6. Subjects must have moderate to severe nodular active facial acne vulgaris (PGA 3 or 4)
7. Willing to sun protect treated area for the duration of enrollment in the study and 1 year after treatment;
8. Subjects must be ineligible for or have declined standard of care treatments (e.g. oral isotretinoin therapy).

Exclusion Criteria:

1. Participation in another investigational drug or device clinical trial in the past 30 days;
2. Currently undergoing or wish to begin or continue topical treatments;
3. Are pregnant or lactating;
4. History of allergic reaction to topical anesthesia;
5. Subjects may not have undergone oral isotretinoin therapy within the past 12 months;
6. Currently take oral antibiotic or oral therapy for acne;
7. History of keloidal or hypertrophic scarring;
8. Laser treatment in past six months;
9. History of poor wound healing;
10. Clinically significant abnormal findings or conditions which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study.

Primary outcomes:
measure: Changes in Physician's Global Assessment (PGA) of Acne Severity
timeFrame: Change in PGA score between baseline visit and post procedural visit
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: MGH Clinical Unit for Research Trials & Outcomes in Skin
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Dieter Manstein, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00859027: Effect Of Risedronate On Bone Mass In Older Men Receiving Neoadjuvant Therapy For Prostate Cancer
Official title: The Effect Of Risedronate On Bone Turnover And Bone Mass In Older Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prostate Cancer
Keywords: Non-metastatic
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: Proctor and Gamble/Aventis
First posted: 2009-03-10
Enrollment: 50
Sex: MALE
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, placebo controlled trial.
Primary purpose: TREATMENT

Brief summary: Men treated with neoadjuvant luteinizing hormone-releasing hormone (LHRH)-agonists such as leuprolide and goserelin for prostate cancer will become hypogonadal due to hormonal suppression and demonstrate increased bone turnover and consequent bone loss at the hip and spine. This bone loss can be prevented by treatment with 35 mg/week of risedronate.

Detailed description: A 6-month randomized, double-blind, placebo-controlled trial was conducted, including 40 men aged ≥ 55 years receiving LHRH-agonist treatment for 6 months for locally advanced prostate cancer. Bone mineral density (BMD) of the lumbar spine, femoral neck, and total hip was measured every 6 months. In addition, bone turnover markers including N-telopeptide, serum C-telopeptide and procollagen peptide, and 25-OH vitamin D and intact parathyroid hormone were measured at baseline and at 6 months.

Eligibility criteria: Inclusion Criteria:

* Non-metastatic prostate cancer
* Men to receive Gonadotropin-releasing Hormone-agonist therapy

Exclusion Criteria:

* Other cancers except skin cancer
* Evidence of metabolic bone disease
* Prior use of bisphosphonates

Primary outcomes:
measure: Percent Change in Bone Mineral Density
timeFrame: baseline and 6 months
Secondary outcomes:
measure: Percent Change of Bone Turnover Markers
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
Study officials:
affiliation: UConn Health
name: Pamela Taxel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05269927: A Multi-domain Approach for the Characterization and Early Diagnosis of Neurodevelopmental Disorders
Official title: A Multi-domain Approach for the Characterization and Early Diagnosis of Neurodevelopmental Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurodevelopmental Disorders
Keywords: Neurodevelopmental disorder
EEG
Multi-domain data
Machine Learning
Lead sponsor: IRCCS Eugenio Medea
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Italy
First posted: 2022-03-08
Enrollment: 300
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Diagnosis and characterization of neurodevelopmental disorders are considered challenging processes because of their complexity, multi-factoriality and heterogeneity. The present project will consider two of the most common neurodevelopmental disorders (i.e. autism spectrum disorders (ASD) and language disorders (LD)), with the aim to overcome these difficulties, by: a) deeply investigating their neuronal correlates; b) identifying multi-domain biomarkers (electrophysiological, genetic, environmental and clinical); c) developing a machine learning algorithm for early diagnosis. To achieve the above mentioned aims a multi-domain dataset will be used, comprising data collected from typically developing infants, infants at high risk for ASD and infants at high risk for LD. The data that will be used have been already collected within other trials performed at the Scientific Institute E. Medea.


Eligibility criteria: Inclusion Criteria:

* APGAR scores at birth at 1' and 5' \> 7;
* newborn screening otoacoustic emissions in the norm;
* absence of neurological disorders;
* Italian as the language mainly spoken in the family nucleus.

Exclusion Criteria:

* APGAR scores at birth at 1' and 5' \<= 7;
* newborn screening otoacoustic emissions not in the norm;
* presence of neurological disorders;
* non-Italian native speaker

Primary outcomes:
measure: EEG power spectral density (PSD)
timeFrame: one year after the end of the recruitment
measure: EEG signal coherence
timeFrame: 18 months after the end of the recruitment
measure: EEG signal entropy
timeFrame: 18 months after the end of the recruitment
Secondary outcomes:
Other outcomes:
Locations:
city: Bosisio Parini
country: Italy
facility: Scientific Institute IRCCS E. Medea
state: Lecco
Study officials:
References:
Clinical trial NCT00842127: Genetic Polymorphism and OROS-Methylphenidate Treatment in Attention Deficit Hyperactivity Disorder(ADHD)
Official title: Genetic Polymorphism of Drug Transporters in OROS-Methylphenidate Treatment in Children and Adolescents With Attention Deficit Hyperactivity Disorder(ADHD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Methylphenidate
ADHD
Multidrug resistance(MDR)polymorphism
OROS methylphenidate
Lead sponsor: Bundang CHA Hospital
Sponsor class: OTHER
Collaborators: name: Hallym University Medical Center
First posted: 2009-02-12
Enrollment: 150
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine whether genetic polymorphisms in drug transporters were associated with the side effects of OROS-methylphenidate medication in attention deficit/hyperactivity disorder(ADHD).

Detailed description: 20 to 30% of children with attention deficit/hyperactivity disorder(ADHD) do not respond or could not tolerate methylphenidate treatment. Drug transporters such as multidrug resistant proteins(MDR) plays important role in the clearance of psychotropic drugs and their metabolites from brain tissue. It suggested that methylphenidate was a P-glycoprotein(encoded by MDR1 gene)substrate and showed inhibitory effects on the P-glycoprotein efflux function. Single nucleotide polymorphisms(SNP)in the MDR1 gene were analyzed in children and adolescents with OROS-methylphenidate treatment. The hypothesis is that MDR1(ABCB1) polymorphisms are associated with the side effects of OROS-methylphenidate.

Eligibility criteria: Inclusion Criteria:

* ADHD
* Must be able to swallow a capsule

Exclusion Criteria:

* Pervasive developmental disorder
* Mental retardation
* Psychotic disorder
* Bipolar disorder
* Suicidality
* Neurological disorder
* Concurrent psychiatric treatment

Primary outcomes:
measure: Barkley side effects rating scale
timeFrame: weeks 1, 2,4,8
Secondary outcomes:
measure: ADHD rating scale-Korean version; Clinical Global Impressions (CGI) of Severity and Improvement (CGI-S and CGI-I)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Bundang CHA hospital
state: Kyonggi-do
Study officials:
affiliation: Department of psychiatry CHA university college of medicine
name: Ki-Hwan Yook, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02082327: A Phase 1 Study To Evaluate the Safety of Migalastat Hydrochloride Given Intravenously to Healthy Volunteers
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Dose Escalation Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of Migalastat Hydrochloride Given Intravenously to Healthy Volunteers With an Open-Label, Randomized, Two-Way Crossover Arm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Fabry Disease
Keywords: Fabry Disease
Fabry
Lysosomal storage disorders
LSD
Amicus
migalastat HCl
migalastat
AT1001
Lead sponsor: Amicus Therapeutics
Sponsor class: INDUSTRY
First posted: 2014-03-10
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of IV migalastat HCl alone and to determine absolute bioavailability for oral migalastat HCl as compared to IV administered migalastat HCl in healthy volunteers. The data from this study will help us understand how migalastat works in the body and will help us determine what would be an effective dose in future studies with migalastat hydrochloride.


Eligibility criteria: Inclusion Criteria:

* Males and females between 18 and 45 years of age.
* Body weight range ≥ 50 kg ≤ 100 kg and BMI within the range 18.5 - 29.9 kg/m2.
* Healthy as determined by a responsible and experienced physician, based on a medial evaluation.
* Male and female subjects of childbearing potential agree to adhere to the contraception requirements.
* Capable of giving written informed consent.

Exclusion Criteria:

* History of sensitivity to migalastat HCl or related iminosugars (eg, miglitol, miglustat), or other significant drug allergy.
* Past medical history, or physical examination findings, of clinically significant abnormalities that may put the subject at risk or interfere with outcome variables.
* Positive pre-study drug/alcohol screen.
* Pregnant or lactating females.
* The subject has participated in a clinical trial and has received an investigational product within 60 days prior to the first dosing day in the current study.

Primary outcomes:
measure: Plasma pharmacokinetics of migalastat
timeFrame: Pre-dose, 0.25, 0.5, 1, 1.5, 2.0, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48
measure: Safety and tolerability of migalastat
timeFrame: 48 hours
Secondary outcomes:
measure: Plasma pharmacokinetics of migalastat
timeFrame: Pre-dose, 0.25, 0.5, 1, 1.5, 2.0, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48
measure: Urinary pharmacokinetics
timeFrame: Pre dose, between 0-6, 6-12 and 12-24 hours after start of infusion
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: PRA International
Study officials:
affiliation: Amicus Therapeutics
name: Medical Monitor Clinical Research
role: STUDY_DIRECTOR
References:
Clinical trial NCT03414827: Genetic Evaluation of Renal Cell Carcinoma; Predicting Biomarkers for Renal Cell Carcinoma
Official title: Genetic Evaluation of Renal Cell Carcinoma; Predicting Biomarkers for Renal Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Kidney Cancer
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2018-01-30
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * Patients who have been diagnosed with kidney cancer and found suitable for inclusion will be included in the project.
* The biological material has been collected during routine treatment.
* Biological material has not been collected in connection with a previous study.

Brief summary: Recruitment of participants to the study takes place at the urological department at Zealand University Hospital, Roskilde, Feb. 2018-April 2018. 10 people with diagnosis of renal cancer should be recruited in phases 1. Subsequently, biological materials from 100 patients with kidney cancer will be used from the national Biobank. In phase 3, 10 patients will be recruited for the final gene test.


Eligibility criteria: Inclusion Criteria:

* Patients who have been diagnosed with kidney cancer.

Exclusion Criteria:

* Patients without signs of malignancy at final histology report.
* Incapacitated patients.

Primary outcomes:
measure: DNA
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: Zealand University Hospital
Study officials:
References:
citation: Maia MC, Salgia M, Pal SK. Harnessing cell-free DNA: plasma circulating tumour DNA for liquid biopsy in genitourinary cancers. Nat Rev Urol. 2020 May;17(5):271-291. doi: 10.1038/s41585-020-0297-9. Epub 2020 Mar 17.
Clinical trial NCT04608227: Non-invasive Haemodynamic Monitoring to Predict Spinal Hypotension During Caesarian Section
Official title: Can Non-invasive Haemodynamic Monitoring With Clearsight(r) Predict Spinal Hypotension During Caesarian Section? A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypotension
Pregnancy Related
Spinal Anesthetics Causing Adverse Effects in Therapeutic Use
Lead sponsor: Hospital Nord
Sponsor class: OTHER
First posted: 2020-10-29
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: prospective inclusion of 3 rd trimester pregnant women undergoing spinal anesthesia for elective ceasarean section

Brief summary: Spinal anaesthesia for elective caesarean section is associated with maternal hypotension, secondary to alteration of sympathetic tone and hypovolemia, in up to 70% of cases.

Our objective, in this prospective single-centre observational study, was to assess the ability of change in systolic ejection volume after 45° passive leg raising to predict hypotension after spinal anaesthesia. Systolic ejection volum was monitored with non-invasive Clearsight Device just before elective caesarean section in third trimester pregnant women.


Eligibility criteria: Inclusion Criteria:

* third trimester pregnant women undergoing elective ceasarean section under spinal anesthesia

Exclusion Criteria:

* emergent ceasarean section
* eclampsia or pre-eclampsia
* undergoing anti-hypertensive treatment
* arythmia

Primary outcomes:
measure: Systolic Ejection volume (mL)
timeFrame: 30 minutes
Secondary outcomes:
measure: Velocity - Time - Integral (cm)
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Marseille
country: France
facility: Departement anesthesie reanimation hopital nord
Study officials:
References:
Clinical trial NCT02467127: Vitamin D Plasma Level and Its Role in Headache
Official title: The Role of Vitamin D Plasma Levels in the Development of Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Headache
Lead sponsor: University of Catanzaro
Sponsor class: OTHER
First posted: 2015-06-09
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To date there are conflicting data concerning a correlation between plasma vitamin D levels and headache.

The aim of this study was to evaluate plasma vitamin D levels in patients with headache admitted to the Center of Headache of Pugliese Ciaccio Hospital.

Detailed description: Several papers suggest that inflammation is able to induces both headache and low levels of vitamin D. However, to date a correlation between plasma vitamin D levels and headache has not been demonstrated. Recently we documented that low levels of Vitamin D are related to a low statin efficacy. In this study we will evaluate the plasma levels of vitamin D in patients with headache admitted to the Center of Headache of Pugliese Ciaccio Hospital.

Moreover it will be also evaluated:

* the correlation between efficacy and safety of drugs used in headache treatment and plasma vitamin D levels.
* the role of vitamin D supplementation on both headache symptoms and drug effects.

Plasma vitamin D levels in patients with headache will be evaluated respect to patients without headache.

Eligibility criteria: Inclusion Criteria:

* acute or chronic headache diagnosed according to the clinical and radiological criteria of the headache Association

Exclusion Criteria:

* allergy to drugs,
* progressive serious medical conditions (such as cancer, AIDS or end-stage renal disease)
* renal diseases (serum creatinine concentration more than 1.2 times the upper limit of the normal range according to the central laboratory definition reference values)
* liver dysfunction (serum alanine or aspartate transaminase concentrations more than 1.5 times the upper limit of normal range according to the central laboratory definition reference values)
* alcohol consumption (\>3 alcoholic beverages daily)
* substance abuse
* inability to give written informed consent
* actual or recent (3-month) treatment with corticosteroids, indomethacin or other antinflammatory drugs.
* secondary headache

Primary outcomes:
measure: Plasma levels of vitamin D using high performance liquid chromatography
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Headache pain through the Visual Analog Scale (VAS)
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: Pugliese Hospital
Study officials:
affiliation: University of Catanzaro
name: Luca Gallelli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06467227: Exposure to the Aerobic Training Stimulus in Healthy Individuals
Official title: EFFECTIVE AEROBIC EXERCISE TRAINING IN HEALTH AND CHRONIC DISEASE. Part I: A Demonstration of Practical Implications of Muscle Recruitment on Exposure to the Aerobic Training Stimulus in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Lead sponsor: West Park Healthcare Centre
Sponsor class: OTHER
First posted: 2024-06-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A prospective longitudinal, self-controlled, single-case repeated measures, randomized and counterbalanced cross-over experimental trial design, comparing cardiopulmonary response and endurance with different modes of exercise
Primary purpose: TREATMENT

Brief summary: Fitness is an important determinant for health and influenced by using large muscles. Muscles respond to training. We want to know if adding arm exercise to leg exercise can provide a better training session for healthy individuals. If the strategy shows promise for healthy people then it might work for people with lung disease who have trouble training because of difficulty breathing. The purpose of this first study is to evaluate, in healthy people, a unique approach to training by determining if adding arm exercise to leg exercise can be endured longer than leg exercise alone.


Eligibility criteria: Inclusion Criteria:

* healthy individuals

Exclusion Criteria:

* orthopedic or neurological condition that might affect the performance of the treadmill, arm or leg cycling
* have a symptomatic cardiac disease or undergone a recent surgical procedure that might affect the performance on an exercise test
* presence of any chronic respiratory condition

Primary outcomes:
measure: cycling endurance time
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Westpark Health Care Centre
state: Ontario
Study officials:
affiliation: West Park Healthcare Centre
name: Roger Goldstein
role: PRINCIPAL_INVESTIGATOR
References: