louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01071239: Hematopoietic Stem Cell Transplant for Fanconi Anemia
Official title: A Phase II Trial of Hematopoietic Stem Cell Transplantation for the Treatment of Patients With Fanconi Anemia Lacking a Genotypically Identical Donor, Using a Chemotherapy Only Cytoreduction With Busulfan, Cyclophosphamide and Fludarabine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fanconi Anemia
Keywords: Fanconi Anemia
Hematopoietic stem cell transplant
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Memorial Sloan Kettering Cancer Center
First posted: 2010-02-19
Enrollment: 1
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The trial proposed is a single arm phase II treatment protocol designed to examine engraftment, toxicity, graft-versus-host disease, and ultimate disease-free survival following a novel cytoreductive regimen including busulfan, cyclophosphamide and fludarabine and anti-thymocyte globulin (ATG- a non-chemotherapy drug whose role is to kill your immune system) for the treatment of patients with Fanconi anemia who have severe aplastic anemia (SAA), or myelodysplastic syndrome (MDS) or acute myelogenous leukemia (AML), lacking HLA-genotypically identical donors using stem cell transplants derived from (1) HLA-compatible unrelated donors or (2) HLA haplotype-mismatched related donors.

Detailed description: We are currently recruiting patients.

Eligibility criteria: Inclusion Criteria:

* Fanconi Anemia (confirmed by mitomycin C or DEB chromosomal breakage testing and one of the following hematological diagnoses: Severe Aplastic Anemia, Myelodysplastic Syndrome, Acute Myelogenous Leukemia
* Karnofsky or Lansy performance scale \> or = to 70%.
* Must have adequate cardiac, hepatic, renal and pulmonary function.
* Must have 7/8 or 8/8 available unrelated donor.

Exclusion Criteria:

* Pregnant or breastfeeding.
* Active CNS leukemic involvement
* Active uncontrolled viral, bacterial or fungal infection
* Positive for HIV.

Primary outcomes:
measure: To measure the incidence and quality of engraftment and hematopoietic reconstitution.
timeFrame: 1, 3, 6 and 12 months post transplant date
Secondary outcomes:
measure: The incidence of early transplant related mortality and incidence and severity of acute and chronic GVHD
timeFrame: weekly for the first 30 days and then 3, 6, and 12 months post transplant date
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: David A Margolis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02122939: A Clinical Trial to Investigate the Pharmacokinetics and the Effect on ECG of Escitalopram in Elderly Volunteers
Official title: An Open-label, Single Dosing Clinical Trial to Investigate the Pharmacokinetics and the Effect on ECG of Escitalopram After Oral Administration in Elderly Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-04-25
Enrollment: 12
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: An Open-label, single dosing clinical trial to investigate the pharmacokinetics and the effect on ECG of escitalopram after oral administration in elderly volunteers.


Eligibility criteria: Inclusion Criteria:

* healthy subject aged 65 or older at screening
* A body weight in the range of 50 kg (inclusive) to 90 kg (inclusive) with BMI range of 19.0 to 28.0
* subjects who decide to participate voluntarily and write a informed consent form

Exclusion Criteria:

* subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor
* Subject judged not eligible for study participation by investigator

Primary outcomes:
measure: Cmax, AUCinf, AUClast, Tmax, t1/2, CL/F
timeFrame: pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 32, 48 h post-dose
Secondary outcomes:
measure: QTc interval
timeFrame: pre-dose, 1, 4, 6, 8, 12, 24, 28, 32, 48 h post-dose
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyounggi
Study officials:
affiliation: Seoul National University Bundang Hospital, Seongnam, Korea
name: Jae-Yong Chung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04369339: Colposcopy Findings Among Women With High Risk HPV Other Than HPV 16/18 and Normal Cytology
Official title: Immediate Colposcopy Findings Among Women With High Risk HPV Other Than HPV 16/18 and Normal Cytology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Papillomavirus Infection
Keywords: Human Papilloma Virus
negative for intraepithelial lesions or malignancy
HPV16
HPV18
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2020-04-30
Enrollment: 185
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective cohort study comparing the immediate colposcopy findings among women with HrHPV other than HVPV16/18 and negative cytology
Primary purpose: DIAGNOSTIC

Brief summary: Abnormal cervical cytology was the most common reason for women being referred to the colposcopy unit. We prospectively included the women with negative cytology (negative for intraepithelial lesions or malignancy (NILM)) and positive High RiskHPV test other than HPV 16 or HPV 18. Comparing the immediate colposcopy findings among women with High Risk HPV other than HVPV16/18 and negative cytology and determine positive predictive values for CIN2+ of other high risk HPV genotypes


Eligibility criteria: Inclusion Criteria:

* negative cytology (negative for intraepithelial lesions or malignancy (NILM)) and positive HrHPV test other than HPV 16 or HPV 18

Exclusion Criteria:

* Previous diagnosis for cervical cancer Previous diagnosis for vaginal cancer Previous diagnosis for cervical dysplasia Previous diagnosis for ASCUS previous history of cervical conisation or hysterectomy previous history ofhysterectomy

Primary outcomes:
measure: Dysplasia
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02184039: Efficacy and Safety of Meloxicam (Mobicox®) in Mexican Population With Rheumatic Diseases
Official title: Clinical Therapeutic Evaluation Program in Patients With Rheumatic Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-09
Enrollment: 12687
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE

Brief summary: Study to evaluate the efficacy and safety of meloxicam (Mobicox®) in Mexican population with rheumatic diseases.


Eligibility criteria: Inclusion Criteria:

* none

Exclusion Criteria:

* Hypersensitivity to meloxicam or to other NSAIDS
* History of asthma, angioedema or urticaria secondary to NSAIDS
* Pregnancy or lactation
* Recent or current history of peptic ulcer disease, severe renal failure, severe hepatic failure
* Age below of 12 years.

Primary outcomes:
measure: Change in intensity of the symptoms measured with a four-point scale
timeFrame: Baseline, 30 and 90 days
Secondary outcomes:
measure: Degree of satisfaction evaluated with a six point numerical rating scale
timeFrame: up to 90 days
measure: Number of patients with adverse events
timeFrame: up to 90 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00969839: NovaLign Intramedullary Fixation System (IFS) for the Treatment of Humeral Fractures
Official title: A Study to Evaluate the Safety and Effectiveness of the NovaLign Intramedullary Fixation System for the Treatment of Humeral Diaphysis Fractures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Fracture
Keywords: Fracture
Humerus
Intramedullary
Fixation
Lead sponsor: NovaLign Orthopaedics, Inc
Sponsor class: INDUSTRY
First posted: 2009-09-01
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: This post-market clinical study is being done to evaluate the use of the NovaLign™ Intramedullary Fixation System in the treatment of humeral fractures.

Detailed description: This is an observational, prospective, nonrandomized open label, post-market clinical study, designed to evaluate the use a flexible intramedullary fixation device used in the treatment of fractures of the humerus. This is a multicentre trial.

Eligibility criteria: Inclusion Criteria:

* Humeral Fracture
* Surgical intervention can be performed within 14 days of injury (injury being Day 0 for this particular criteria)
* Fully functioning contralateral limb (e.g., hand, arm, shoulder)
* Age 18 years or older and skeletally mature

Exclusion Criteria:

* Intraarticular fractures or those involving shoulder or elbow of the index arm
* Pathologic fracture (e.g., tumor involvement, osteomalacia, etc.; osteoporosis is not an exclusion)
* Evidence of neurologic injury in the index arm, including compartment syndrome or radial nerve palsy
* Additional upper body injuries (e.g., upper extremity, abdominal, thoracic, neck or head injury) that may affect or inhibit the evaluation of the index or contralateral arm, shoulder, elbow, etc or would not allow the patient to follow or comply with appropriate post-operative regimens
* Any previous bodily injury or surgery that may interfere with function or evaluation of index or contralateral arm, shoulder, elbow, etc.

Primary outcomes:
measure: Radiographic union and safety
timeFrame: 12 months
Secondary outcomes:
measure: Function, pain, and quality of life assessments at regular intervals
timeFrame: 12 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health Medical Center
state: Colorado
city: Columbia
country: United States
facility: University of Missouri - Columbia
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: B Crist, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00377039: A Multicentre Trial to Determine the Efficacy and Safety of AD-337 in the Treatment of Fibromyalgia
Official title: A Multi-Centre, Randomised, Double-Blind, Placebo Controlled, Parallel Group Exploratory Study to Investigate the Efficacy, Safety and Tolerability of AD 337 in the Treatment of Fibromyalgia in Female Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fibromyalgia
Keywords: ACR 1990 Fibromyalgia
Fibromyalgia Impact Questionnaire
Lead sponsor: Sosei
Sponsor class: INDUSTRY
First posted: 2006-09-15
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicentre, randomized, double-blind, placebo controlled, parallel group exploratory study to investigate the efficacy, safety and tolerability of AD 337 in the treatment of fibromyalgia in female subjects.


Eligibility criteria: Inclusion Criteria:

* Female
* Age 18-65
* Meet ACR 1990 criteria for classification of Fibromyalgia
* Able and willing to discontinue CNS active therapies

Exclusion Criteria:

* If pain is NOT primarily due to Fibromyalgia
* Current or prior history of serious psychiatric disorder
* Pregnant/breastfeeding
* QTc \> 470ms
* Failure to respond to 2 or more adequate regimes of different classes of antidepressants.

Primary outcomes:
measure: The Fibromyalgia Impact Questionnaire total score after 4 weeks treatment
Secondary outcomes:
measure: These will be
measure: FIQ Total score at weeks 1, 2, 3, at end of study and overall
measure: FIQ subscales at weeks 1, 2, 3, 4 at end of study and overall
measure: Short form McGill Pain questionnaire subscales at weeks 1, 2, 3, 4 at end of study and overall
measure: Tender point assessment (ACR 1990 criteria) scores at weeks 2, 4 at end of study and overall
measure: Hospital Anxiety and Depression Scale subscales at weeks 2, 4 and overall
measure: Fibromyalgia Health Assessment Questionnaire total score at weeks 1, 2, 3, 4 at end of study and overall
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: David L Scott
Study officials:
affiliation: King's College London
name: David L Scott
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05993039: Inhalational Anesthesia vs TIVA in Endoscopic Tympanoplasty
Official title: Comparison of Inhalational Anesthesia and Total Intravenous Anesthesia on Surgical Field Quality and Post-operative Recovery in Endoscopic Tympanoplasty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Perforated Eardrum
Keywords: tympanoplasty
Inhalational anesthesia
total intravenous anesthesia
intraoperative blood loss
Lead sponsor: Our Lady of the Lake Hospital
Sponsor class: OTHER
Collaborators: name: Louisiana State University Health Sciences Center in New Orleans
First posted: 2023-08-15
Enrollment: 100
Sex: ALL
Minimum age (years): 0
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double-blinded randomized control
Primary purpose: TREATMENT

Brief summary: This study aims to prospectively compare surgical field quality and intraoperative blood loss between general inhalational anesthesia to total intravenous anesthesia (TIVA) alone in subjects undergoing endoscopic ear surgery. A secondary objective is to compare rates of emergence delirium and total recovery time between the two groups.

Detailed description: In sinus surgery, TIVA has been described as a possible advantage in the use of endoscopic ear surgery. However, to date, there are no studies that examine blood loss, surgical field quality, and recovery in TIVA compared to inhalational anesthesia in the setting of endoscopic ear surgery. The hypothesis is that in patients who undergo endoscopic tympanoplasty, those who receive TIVA will have reduced intraoperative blood loss, improved surgical field quality, and reduced emergence agitation than those who receive inhalational anesthesia. This study will be a prospective double-blinded randomized control trial consisting of subjects undergoing endoscopic tympanoplasty surgery to assess intraoperative blood loss, surgical field quality, rates of emergence delirium, and recovery time.

Eligibility criteria: Inclusion Criteria:

* Individuals of all ages
* Scheduled to undergo an endoscopic tympanoplasty

Exclusion Criteria:

* Individuals with anticoagulation disorders
* Those receiving anticoagulation therapy currently

Primary outcomes:
measure: Surgical Field Quality
timeFrame: Post-Operative evaluation (within 2 weeks)
measure: Intra-operative blood loss
timeFrame: 1-2 hours during surgery
Secondary outcomes:
measure: Emergent Delirium and Recovery Time-Riker Scale
timeFrame: Immediately After extubation
measure: Emergent Delirium and Recovery Time-Richmond Scale
timeFrame: Immediately After extubation
measure: Post-operative pain or complications
timeFrame: 0-1 hour post-operative
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Our Lady of the Lake Hospital
state: Louisiana
Study officials:
affiliation: Our Lady of the Lake Hospital
name: Rahul Mehta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01075139: Brief Motivational Intervention to Increase Physical Activity and Fruit/Vegetable Intake
Official title: Pilot Trial of a Brief Motivational Intervention to Increase Physical Activity and Fruit/Vegetable Intake Among College Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Physical Inactivity
Poor Diet
Keywords: Motivational interviewing
Physical activity
Diet
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2010-02-24
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Research has shown that a high percentage of college students do not meet recommended national guidelines for physical activity or fruit/vegetable intake. The purpose of this study was to pilot test the short-term efficacy of a one-on-one, brief motivational intervention (BMI) designed to increase physical activity and fruit/vegetable intake. It was hypothesized that participants in the BMI condition would report greater physical activity and fruit/vegetable intake at follow-up than those in an education-only control condition.


Eligibility criteria: Inclusion Criteria:

* Two or fewer days of 30+ minutes of moderate physical activity per week
* Zero days of 20+ minutes of vigorous physical activity per week

Exclusion Criteria:

* Three or more days of 30+ minutes of moderate physical activity per week
* One or more days of 20+ minutes of vigorous physical activity per week

Primary outcomes:
measure: Vigorous physical activity minutes per week.
timeFrame: One-month follow-up.
Secondary outcomes:
measure: Moderate physical activity minutes per week.
timeFrame: One-month follow-up.
measure: Fruit and vegetable intake per week
timeFrame: One-month follow-up
Other outcomes:
Locations:
city: Memphis
country: United States
facility: University of Memphis
state: Tennessee
Study officials:
affiliation: University of Missouri-Columbia
name: Matthew P Martens, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martens MP, Buscemi J, Smith AE, Murphy JG. The short-term efficacy of a brief motivational intervention designed to increase physical activity among college students. J Phys Act Health. 2012 May;9(4):525-32. doi: 10.1123/jpah.9.4.525. Epub 2011 May 12.
Clinical trial NCT02410239: MT2014-14 IT-MSC for Advanced Cerebral Adrenoleukodystrophy (cALD)
Official title: MT2014-14 Intrathecal Administration of Mesenchymal Stem Cells (IT-MSC) for the Treatment of Advanced Cerebral Adrenoleukodystrophy (cALD)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Cerebral Adrenoleukodystrophy
Keywords: Cerebral Adrenoleukodystrophy
cALD
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2015-04-07
Enrollment: 0
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the maximum tolerated dose (MTD) of mesenchymal stem cells (IT-MSC) in patients with active, advanced cerebral adrenoleukodystrophy (cALD).

Detailed description: This is a single-institution dose escalation study to determine the maximum tolerated dose (MTD) of intrathecally administered allogeneic, 3rd party mesenchymal stem cells (IT-MSC) in patients with active, advanced cerebral adrenoleukodystrophy (cALD).

Eligibility criteria: Inclusion Criteria:

* Age ≥ 4 years at time of study enrollment
* Diagnosis of ALD - the diagnosis of ALD can be made by either biochemical or molecular/genetic evidence (plasma VLCFA or ABCD1 mutation analysis) supportive of ALD as the cause of cerebral demyelination
* Evidence of active cerebral disease - defined as the presence of gadolinium enhancement on a single brain MRI study - MRI used for eligibility determination may be performed at an outside institution; the most recent MRI used to determine eligibility must be within 2 calendar months of the date of enrollment on this study
* ALD MRI (Loes) score ≥ 10
* Off of N-acetylcysteine, systemic immunosuppressive drugs or any other therapeutic intervention (except hydrocortisone and/or fludracortisone for the treatment of adrenal insufficiency) for ≥ 10 days prior to the first IT-MSC dose
* Life expectancy of \>6 months as determined by the enrolling researcher and documented in the medical record
* Voluntary written consent provided by parent(s)/guardian(s)

Exclusion Criteria:

* A candidate for allogeneic hematopoietic stem cell transplantation as determined by the University of Minnesota Inherited Metabolic and Storage Disease group
* Inability to undergo sedation, lumbar puncture or MRI studies for any reason
* Inability to stay in Minnesota for therapy through the day 28 evaluation

Primary outcomes:
measure: Maximum Tolerated Dose
timeFrame: Day 28 post intrathecal injection of MSC
Secondary outcomes:
measure: Radiographic Response
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Paul Orchard, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04910139: A User Study of the Soniflow System for Nasal Congestion Relief
Official title: A User Study of the Soniflow System for Nasal Congestion Relief
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasal Congestion
Lead sponsor: Third Wave Therapeutics
Sponsor class: INDUSTRY
First posted: 2021-06-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Soniflow System consists of an acoustic vibrational headband paired with a Smartphone App to provide rapid relief of nasal congestion.

Detailed description: The Soniflow System is a non-invasive device to provide rapid relief of nasal congestion. It consists of a headband with ultrasound transducers (hardware) coupled to a Smartphone application (software).

Eligibility criteria: Inclusion Criteria:

1. Subject is \>18 years of age
2. Subject has had moderate to severe symptoms of nasal congestion for \>3 months (TNSS rating of 2 or 3)
3. Subject has signed IRB-approved informed consent form

Exclusion Criteria:

1. Subject has neurologic comorbidities
2. Subject has active dental infection
3. Subject is pregnant
4. Subject has implanted intracranial electrostimulation device(s) (e.g. cochlear implant, deep brain stimulator)
5. Subject has undergone sinonasal or craniomaxillofacial surgery within the lats 3 months
6. Subject has been diagnosed with intracranial hemorrhage within the last 6 months
7. Subject has open scalp wounds or rashes
8. Subject has any history of craniotomy without replacement of a bone flap
9. Subject has elevated sensitivity to sound
10. Any physical condition that in the investigator's opinion would prevent adequate study participation or pose increased risk

Primary outcomes:
measure: Total Nasal Symptom Score
timeFrame: 20 minutes
Secondary outcomes:
measure: Visual Analog Scale (VAS) for Headache
timeFrame: 20 minutes
measure: Visual Analog Scale (VAS) for Facial Pain
timeFrame: 20 minutes
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco Otolaryngology Medical Group
state: California
Study officials:
affiliation: Principal Investigator
name: Jacob Johnson, MD
role: PRINCIPAL_INVESTIGATOR
References: