louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01496079: Maternal Immunization: Giving Immunity For Tomorrow
Official title: The Role of Immunizing Pregnant Women In Protecting Young Infants Against Influenza
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Influenza
Keywords: Maternal immunization
Infant immunization
Influenza vaccine
Passive transfer of immunity
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2011-12-21
Enrollment: 166
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women and their infants receiving care at University of Utah Health Sciences (UUHS) will be recruited and followed.

Brief summary: Study objectives are to compare

* influenza antibody levels in infant sera and maternal colostrum or breast milk at delivery, 2, and 6 months women who receive influenza immunization in early pregnancy, late pregnancy, or no influenza immunization during pregnancy and their infants

Study hypotheses are that infants born to pregnant women who receive influenza immunization in late pregnancy will have

* higher levels and a longer serum influenza antibody duration in sera (hemagglutination inhibition (HAI) titers) and colostrum/breast milk (influenza-specific IgA and IgG by enzyme-linked immunosorbent assay (ELISA) than infants of women immunized in early pregnancy or not immunized


Eligibility criteria: Inclusion Criteria:

Pregnant women 18-45 years of age from 8-36 weeks gestation in good health as determined by medical history and recent physical exam who

* receive prenatal care at the UUHS Obstetrics and Gynecology Clinics and their infants
* plan to seek care for their infant at the UUHS affiliated Pediatric Clinics (UUHS or SMC Pediatric Clinics)
* plan for their infant to receive influenza immunization at 6 and 7 months of age

Exclusion Criteria:

* maternal history of either a congenital or acquired immunodeficiency including infection (e.g. HIV), chronic steroid use, or malignancy
* serious underlying neurological, cardiac, renal, or pulmonary disease in either the mother or infant
* multiple gestation
* antenatal or postnatal detection at delivery of any major birth defect in the infant
* delivery of the infant before 37 weeks

Primary outcomes:
measure: Influenza antibody titer levels in infants born to women who receive inactivated influenza vaccine in early pregnancy compared with late pregnancy and no immunization
timeFrame: Infant antibody titers at delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Health Sciences Center
state: Utah
Study officials:
affiliation: University of Utah
name: Julie H. Shakib, DO, MS, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06880679: Ultrasound Acute Chest Syndrome Sickle Cell Disease
Official title: Use of Point-of-Care Ultrasound (POCUS) for the Diagnosis of Acute Chest Syndrome in Patients With Sickle Cell Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Chest Syndrome
Sickle Cell Disease
Keywords: Sickle Cell Disease
Sickle Cell Anemia
Acute Chest Syndrome
POCUS
Ultrasound
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2025-03-18
Enrollment: 30
Sex: ALL
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Feasibility and reliability of ultrasound in the inpatient hematology setting.

Detailed description: Acute chest syndrome (ACS) is a complication of sickle cell disease where individuals have symptoms of fever, low oxygen levels or difficulty breathing in the setting of a new lung finding on chest x-ray. Chest x-ray is a useful tool to identify it but has some side effects. The investigators think ultrasound will be an equally feasible, reliable tool and minimize some of the side effects associated with chest x-ray. Ultrasound is a non-invasive was to obtain an image that does not require radiation.

Eligibility criteria: Inclusion Criteria:

1. Age: 0-25 years old
2. Diagnosis: Patients with a documented diagnosis of sickle cell disease (any genotype)
3. Disposition: Hospitalized for a SCD-related complication (e.g. VOC)

Exclusion Criteria:

1. Patient is considered hemodynamically unstable to undergo consent and study procedures
2. Already has diagnosis of ACS prior to admission to inpatient unit
3. POCUS operator not available

Primary outcomes:
measure: Participation rate
timeFrame: Up to 5 days
measure: Retention rate
timeFrame: Up to 5 days
measure: Duration of exam
timeFrame: Up to 5 days
measure: Acceptability of POCUS by the medical team (physicians and nursing)
timeFrame: Up to 5 days
Secondary outcomes:
measure: Reliability of point of care ultrasound (POCUS) compared to standard of care (Chest X-ray)
timeFrame: Up to 5 days
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Indiana University
name: Seethal Jacob, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02486679: A Trial of Prostaglandin E2 Tablets Versus Foley Catheter for Labor Induction
Official title: Cervical Ripening at Term With Prostaglandin E2 Tablets Versus Foley Catheter: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Labor, Induced
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2015-07-01
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized controlled trial comparing labor induction with vaginal PGE2 tablets and foley catheter for cervical ripening.


Eligibility criteria: Inclusion Criteria:

* Singleton term pregnancies (\>37 weeks), vertex presentation
* Intact membranes
* Low Bishop score (\<7)
* First, second or third delivery
* Medical indication for induction
* Viable fetus

Exclusion Criteria:

* Contraindication for vaginal delivery, for PGE2 or foley catheter
* Gestational age\<37 weeks, premature rupture of membranes, fetal or uterine malformations, previous cesarean section, uncertain dating, unwilling to participate in trial

Primary outcomes:
measure: Time to active labor
timeFrame: Post labor- up to 24 hours
Secondary outcomes:
measure: Delivery within 24 hours
timeFrame: post-labor - up to 24 hours
measure: Cesarean section rate
timeFrame: post labor - up to 24 hours
measure: Maternal complications
timeFrame: participants will be followed for labor course and the duration of hospital stay, an expected average of 5 days
measure: Neonatal complications
timeFrame: Neonates of participants will be followed for labor course and the duration of hospital stay, up to 1 month
Other outcomes:
Locations:
city: Holon
country: Israel
facility: Edith Wolfson Medical Center
Study officials:
References:
Clinical trial NCT05304884: Ozone Injection for Shoulder Impengement Syndrome
Official title: Clinical and Functional Outcomes of a Single Dose Ozone, Three Doses of Ozone and Corticosteroid Injection in Patients With Shoulder Impingement Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Research on the Effectiveness of a Corticosteroid, Single Dose and Three Doses of Ozone Injection in Shoulder Impingement Syndrome
Lead sponsor: Erzurum Regional Training & Research Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Karadeniz Technical University
First posted: 2022-03-31
Enrollment: 108
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1 received a single dose (n:36), group 2 (n:36) received three doses of ozone injection (n :36). Group 3 (n:36) was treated with a corticosteroid injection.
Primary purpose: TREATMENT

Brief summary: Ozone injection has lately been utilized as a safe alternative to corticosteroids in the management of musculoskeletal diseases with fewer side effects. This study aimed to compare the effectiveness of a corticosteroid, single dose and three doses of ozone injection in shoulder impingement syndrome (SIS).

Detailed description: A hundred and eight SIS patients were divided into three groups and underwent subacromial injections in this prospective study. Group 1 received a single dose (n:36), group 2 (n:36) received three doses of ozone injection (n :36). Group 3 (n:36) was treated with a corticosteroid injection. Patients were evaluated using the visual analog scale (VAS) and Constant Murley Score (CMS), pre-injection and at 4 weeks and 12 weeks.

Eligibility criteria: Inclusion Criteria: patients older than 18 years with shoulder pain lasting for more than three months, pain severity more than 5/10 on Visual Analog Scale (VAS), and diagnosed with SIS according to clinical examination and magnetic resonance imaging (MRI), were enrolled in this randomized clinical study.

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Exclusion Criteria: The exclusion criteria were as follows: existing pathological abnormalities such as full-thickness rotator cuff tears on MRI, any cause of shoulder pain other than SIS such as inflammatory joint diseases, shoulder osteoarthritis and adhesive capsulitis, restriction of shoulder range of motion, coagulation disorders or use of anticoagulants, previous history of shoulder trauma, surgery or fracture, history of any subacromial injection or physical therapy for the last year, contraindications for ozone injection such as known Glucose 6 phosphate dehydrogenase deficiency, pregnancy, uncontrolled hyperthyroidism, and leukemia.

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Primary outcomes:
measure: The visual analog scale (VAS)
timeFrame: 3 months
Secondary outcomes:
measure: Constant Murley Score (CMS)
timeFrame: 3 months
Other outcomes:
Locations:
city: Merkez
country: Turkey
facility: KTU Medical Faculty
state: Trabzon
Study officials:
References:
Clinical trial NCT02278484: Sinus Balloon Dilation in Pediatric Patients
Official title: XprESS Device and PathAssist Confirmation Tools in Pediatric Patients-Expanded Indication Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sinusitis
Keywords: sinus infections
sinusitis
chronic sinusitis
rhinosinusitis
allergic sinusitis
allergic rhinitis
chronic rhinosinusitis
sinus disease in children
sinus balloon dilation
balloon dilatation
sinus disease
pediatric
Lead sponsor: Entellus Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2014-10-30
Enrollment: 50
Sex: ALL
Minimum age (years): 2
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Safety and effectiveness of sinus balloon dilation in patients 2-21 years old.


Eligibility criteria: Inclusion Criteria:

Patients age ≥ 2 to ≤ 21 years old. Diagnosed with Chronic Rhinosinusitis (CRS). Candidate for trans-nasal balloon sinus dilation.

Exclusion Criteria:

History of sinus surgery. Recent nasal or head and neck surgery. Fungal sinus disease. Severe asthma. Cystic fibrosis. Immunodeficiency. Craniofacial abnormalities. Pregnancy (current)

Primary outcomes:
measure: Technical Success: Sinuses Successfully Treated With Balloon Dilation
timeFrame: Index procedure
measure: Complications
timeFrame: Index procedure through 3-month follow-up
Secondary outcomes:
measure: Change in Quality of Life From Baseline Through Completion
timeFrame: Baseline to 6-month follow-up
measure: Number of Subjects Who Undergo a Revision or Additional Surgery During the Study
timeFrame: Procedure-6 month follow up
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: North Valley ENT
state: Arizona
city: Salem
country: United States
facility: Willamette ENT and Facial Plastic Surgery
state: Oregon
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: San Antonio
country: United States
facility: Alamo ENT and Associates
state: Texas
Study officials:
References:
citation: Soler ZM, Rosenbloom JS, Skarada D, Gutman M, Hoy MJ, Nguyen SA. Prospective, multicenter evaluation of balloon sinus dilation for treatment of pediatric chronic rhinosinusitis. Int Forum Allergy Rhinol. 2017 Mar;7(3):221-229. doi: 10.1002/alr.21889. Epub 2016 Nov 26.
Clinical trial NCT03389984: Psoriatic Inflammation Markers Predictive of Response to Adalimumab
Official title: Characterization of the Initial Psoriatic Skin Transcriptionnl Profile Associated to a Response to Adalimumab Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis Vulgaris
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2018-01-04
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The objective is to compare the initial skin inflammatory transcriptomic profile of psoriatic patient responder to Adalimumab therapy (defined as the achievement of a Psoriasis Area and Severity Index 75 response at 16 weeks) with the transcriptomic profile of patient non-responder to Adalimumab therapy (defined as the non-achievement of a Psoriasis Area and Severity Index 50 response at 16 weeks) to identify differentially expressed genes in order to define predictive markers of response to the treatment.


Eligibility criteria: Inclusion Criteria:

* Chronic plaque psoriasis involving at least 10% of body surface area, with a PASI score \>10,
* Negative pregnancy test for women of childbearing potential, and use of an effective method of contraception,
* Pretreatment assessment to identify contraindications to anti-tumor necrosis factor-alpha therapy (chest x-ray and Intradermal reaction (detection of latent tuberculosis),
* Anti-tumor necrosis factor-alpha treatment with adalimumab has been prescribed

Exclusion Criteria:

* Classical exclusion criteria for adalimumab therapy (hypersensitivity to the product, severe heart failure, abscess, tuberculosis or other opportunistic infection),
* History of demyelinating disease, any unstable medical condition, patients with recurrent serious infections , history of cardiovascular or cerebrovascular disease , history of cancer
* Patients not having tuberculosis prophylaxis as per local guidelines for latent tuberculosis, or patients non-treated active tuberculosis
* Ongoing pregnancy or breastfeeding
* Absence of written consent,
* Prior treatment with one of the following anti-psoriatic treatments: biologics during the 3 months prior baseline visit, other systemic treatment during the 4 weeks prior baseline visit or topical therapy during the 2 weeks prior baseline visit.

Primary outcomes:
measure: Change from baseline messenger ribonucleic acid expression at 16 weeks of treatment
timeFrame: From baseline to 16 weeks treatment
Secondary outcomes:
measure: Change from baseline drug and anti-drug concentrations at 16 weeks of treatment
timeFrame: From baseline to 16 weeks treatment
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU Poitiers
Study officials:
References:
Clinical trial NCT04545684: Effects of Mental Practice on Manual Gripping Motor Function
Official title: Effects of Mental Practice on Manual Gripping Motor Function: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hand Grasp
Keywords: Motor imagery
Lead sponsor: Universidad Autonoma de Madrid
Sponsor class: OTHER
Collaborators: name: Centro Universitario La Salle
First posted: 2020-09-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main objective is to evaluate and quantify the manual gripping force caused by mental practice


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 60
* Healthy and with no pain subjects

Exclusion Criteria:

* Any cognitive impairment that hindered viewing of audiovisual material.
* Difficulty understanding or communicating.
* Presence of systemic pathology, Central Nervous System or rheumatic disease.
* Inadequate understanding of the Spanish language to follow instructions for measuring and treatment.
* Collaboration of pregnant women.
* Underage subjects
* Subjects with pain at the time of the study.

Primary outcomes:
measure: Hand grip strength
timeFrame: Change from baseline and immediately post-intervention
measure: Pain pressure threshold
timeFrame: Change from baseline and immediately post-intervention
Secondary outcomes:
measure: Visual and Kinesthetic Motor Imagery Ability
timeFrame: Immediately before the intervention
measure: The degree of physical activity
timeFrame: Immediately before the intervention.
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: CSEU La Salle
Study officials:
References:
Clinical trial NCT00347984: Product Preference With Systane Compared to Artificial Tears on Frequency of Drop Use
Official title: The Effect of Systane® Compared to Marketed Artificial Tears on Frequency of Drop Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
Collaborators: name: ORA, Inc.
First posted: 2006-07-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to evaluate the effect of Systane® compared to marketed artificial tears on the frequency of drop use.


Eligibility criteria: Inclusion Criteria:

* Subjects age 18 (minimum); reported history of dry eye syndrome in both eyes; TFBUT ≤ 7 seconds in at least 1 eye at Visit 1; ≥ 1+ fluorescein staining score in any region in at least 1 eye at Visit 1; desire to use an artificial tear substitute for dry eye symptoms at least 4 times per day at Visit 1 and Visit 2.

Exclusion Criteria:

* Age less than 18 years

Primary outcomes:
measure: Frequency of drop use and/or desire to use; Drop preference
Secondary outcomes:
measure: Product questionnaire; Symptoms; Corneal and conjunctival staining; Tear film break-up time (TFBUT).
Other outcomes:
Locations:
city: Andover
country: United States
facility: Maryland
state: Massachusetts
Study officials:
affiliation: Alcon Research
name: Mike Christensen
role: STUDY_DIRECTOR
References:
Clinical trial NCT04160884: Fluorescence-navigated Thoracoscopy for Pulmonary Segmentectomy
Official title: Fluorescence-navigated Thoracoscopy for Pulmonary Segmentectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Segmentectomy
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Municipal Science & Technology Commission
First posted: 2019-11-13
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recently developed fluorescence-navigated thoracoscopy with indocyanine green (ICG) is being used for various kinds of pulmonary surgery, and several studies have reported the application of this novel technique in demarcation of the intersegmental border for segmentectomy. This study is performed prospectively to find out, for the first time, the optimal dosage of ICG in human body to ensure safe and sustained imaging during segmentectomy.


Eligibility criteria: Inclusion Criteria:

* Suitable for segmentectomy and signed informed consent

Exclusion Criteria:

* Liver dysfunction.
* Allergic to indocyanine green.
* Can't tolerate thoracoscopic surgery.

Primary outcomes:
measure: Signal-to-background Ratio (SBR) of the Targeted and Non-targeted Segments
timeFrame: Surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT00332579: Double-Blind Naltrexone in Kleptomania
Official title: A Double-Blind, Placebo-Controlled Study of Naltrexone in Kleptomania
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Kleptomania
Keywords: Compulsive Shoplifting
Kleptomania
Compulsive Stealing
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2006-06-01
Enrollment: 25
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of the proposed study is to evaluate the efficacy and safety of naltrexone in kleptomania.

Detailed description: The proposed study will consist of 8 weeks of treatment with either naltrexone or placebo in 20 subjects with kleptomania. The hypothesis to be tested is that naltrexone will be effective in reducing the urges to steal in patients with kleptomania. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.

Eligibility criteria: Inclusion Criteria:

1. men and women age 21-75
2. current DSM-IV kleptomania.

Exclusion Criteria:

1. unstable medical illness or clinically significant abnormalities on prestudy laboratory tests or physical examination
2. history of seizures
3. myocardial infarction within 6 months
4. current pregnancy or lactation, or inadequate contraception in women of childbearing potential
5. clinically significant suicidality
6. current or recent (past 3 months) DSM-IV substance abuse or dependence
7. illegal substance within 2 weeks of study initiation
8. initiation of psychotherapy or behavior therapy from a mental health professional for the treatment of kleptomania within 3 months prior to study baseline
9. initiation of a psychotropic medication within 2 months prior to study inclusion
10. previous treatment with naltrexone
11. treatment with investigational medication or depot neuroleptics within 3 months, with fluoxetine within 6 weeks, or with other psychotropics within 2 weeks prior to study baseline.

Primary outcomes:
measure: Yale Brown Obsessive Compulsive Scale Modified for Kleptomania (K-YBOCS)
timeFrame: K-YBOCS is done at each visit by the investigator.
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Jon E Grant, MD, JD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grant JE, Kim SW, Odlaug BL. A double-blind, placebo-controlled study of the opiate antagonist, naltrexone, in the treatment of kleptomania. Biol Psychiatry. 2009 Apr 1;65(7):600-6. doi: 10.1016/j.biopsych.2008.11.022. Epub 2009 Feb 12.