louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03639857: Study of the Efficacy of 532nm Laser and 1064 nm Laser in the Treatment of Cutaneous Lupus Erythematous Versus Topical Corticosteroids Alone
Official title: A Comparative Study of the Efficacy of 532nm Laser and 1064 nm Laser in the Treatment of Cutaneous Lupus Erythematous Versus Topical Corticosteroids Alone
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cutaneous Lupus
Lead sponsor: University of Central Florida
Sponsor class: OTHER
First posted: 2018-08-21
Enrollment: 3
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: This study aims to compare the efficacy of 532nm Potassium Titanyl Phosphate (KTP) laser and 1064 nm Neodymium-doped Yttrium Aluminum Garnet (Nd:YAG) laser as adjuncts to topical corticosteroids in the treatment of cutaneous lupus erythematosus versus topical corticosteroids alone.


Eligibility criteria: Inclusion Criteria:

* Male or female adult 18 years of age or older
* Ability to rate level of pain
* Ability to rate visual satisfaction
* At least 2 active lesions of CLE

Exclusion Criteria:

* New or change in systemic medication for cutaneous lupus in past 6 months
* Allergy to triamcinolone or betamethasone dipropionate cream
* Pregnancy
* Currently a prisoner
* Unable to read and speak English since consent will only be available in English

Primary outcomes:
measure: Limited CLASI
timeFrame: 2 Months
measure: VAS for Appearance
timeFrame: 2 Months
measure: VAS for Pain
timeFrame: 1 Month
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: UCF Health Lake Nona Office
state: Florida
Study officials:
References:
Clinical trial NCT02168257: Neotech RAM Cannula Versus Conventional Binasal Prong Continuous Positive Airway Pressure (CPAP) to Treat Respiratory Distress in Low Birth Weight Neonates
Official title: Neotech RAM Cannula Versus Conventional Binasal Prong Continuous Positive Airway Pressure (CPAP) to Treat Respiratory Distress in Low Birth Weight Neonates
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Respiratory Distress Syndrome, Newborn
Continuous Positive Airway Pressure
Low Birth Weight Infants
Keywords: Nasal Cannula
Lead sponsor: Children's Hospitals and Clinics of Minnesota
Sponsor class: OTHER
First posted: 2014-06-20
Enrollment: 8
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 determine if the RAM cannula is as effective as conventional binasal prongs to deliver CPAP to low birth weight infants with respiratory distress.


Eligibility criteria: Inclusion Criteria:

* Low Birth Weight Infant
* Currently on continuous positive aireway pressure of 5-7 cm water pressure
* Receiving continuous positive airway pressure support for \> 24 hrs prior to enrollment
* Fraction of inspired oxygen requirement of 23-50%

Exclusion Criteria:

* Fraction of inspired oxygen \> 50%
* Congenital defects of head, pulmonary or cardiovascular systems
* Chromosomal abnormalities/genetic syndromes
* Invasive Surgical Procedure within 24 hrs prior to enrollment
* Enrollment in separate clinical trial that has ongoing data collection

Primary outcomes:
measure: Oxygenation
timeFrame: 3 hrs
measure: Ventilation
timeFrame: 3 hrs
Secondary outcomes:
measure: Esophageal pressure measurements
timeFrame: 3 hrs
measure: Apnea
timeFrame: 3 hrs
Other outcomes:
measure: Pulse
timeFrame: 3 hrs
measure: Respiratory Rate
timeFrame: 3 hrs
measure: Blood Pressure
timeFrame: 3 hrs
measure: Oxygen requirement
timeFrame: 3 hrs
Locations:
city: Saint Paul
country: United States
facility: Children's Hospitals and Clinics of Minnesota
state: Minnesota
Study officials:
affiliation: Children's Hospitals and Clinics of Minnesota
name: Neil P Mulrooney, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospitals and Clinics of Minnesota
name: Andrea L Lampland, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01831557: The Genetic Basis of the Influence of Dairy Product Intake on Body Measures in Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Body Mass Index
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-04-15
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children from a community sample

Brief summary: The objective of this study is to explore the genetic basis of the influence of dairy product intake on body measures in children. The investigators assume that the effect of dairy products intake on children body measures is affected by genetic polymorphisms.


Eligibility criteria: Inclusion Criteria:

* Healthy children

Exclusion Criteria:

* Sick children
* Chronic diseases

Primary outcomes:
measure: Body indexes measurements
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
Clinical trial NCT02816957: Benefits of Nigella Sativa in Children With Beta Thalassemia Major
Official title: Study of The Therapeutic Benefits of Nigella Sativa in Children With Beta Thalassemia Major
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Nigella Sativa With Beta Thalassemia Major
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2016-06-29
Enrollment: 80
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the therapeutic effects health benefits, and immunological effect of Nigella sativa in children with beta thalassemia major.

Detailed description: Study will be carried on children patients with β- thalassemia major attending The Hematology Unit of Pediatric Department at Tanta University Hospital. patients are divided into 2 groups: patients in the control group, patients in the treatment group that will receive nigella sativa powder for 3 consecutive months. Then Evaluate the therapeutic effects health benefits, and immunological effect of Nigella sativa in children with beta thalassemia major.

Evaluate the extent of clinical improvement, reductions in serum iron and ferritin, antioxidant status, treatment of the causes of hemolysis and other therapeutic benefits of Nigella sativa in those patient.

Eligibility criteria: Inclusion Criteria:

* Thalassemia with iron overload

Exclusion Criteria:

* Thalassemia complicated with diabetes mellitus or hepatitis
* Patients who discontinue treatment

Primary outcomes:
measure: malondialdehyde
timeFrame: 3 months
measure: cluster of differentation4 and 8(CD4 and CD8)
timeFrame: 3 months
measure: total antioxidant
timeFrame: 3 months
Secondary outcomes:
measure: Serum iron
timeFrame: 3 months
measure: total iron binding capacity
timeFrame: 3 months
measure: serum ferritin
timeFrame: 3 months
measure: complete blood count
timeFrame: 3 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Faculty of Medicine- Tanta University
state: Gharbia
Study officials:
affiliation: professor of pediatrics
name: Mohamed Ramadan ELshanshory, prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT01909557: Acetyl-L-Carnitine Supplementation During HCV Therapy With Peg IFN-α2b Plus Ribavirin: Effect on Work Performance.
Official title: Effect of Supplementation of Antioxidant Substances and Probiotics in HCV Correlated Liver Disease Treated With Interferon and Ribavirin. Studies on Biochemical and Virological Response and on Quality of Life.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Quality of Life
Daily Activity
Fatigue
Keywords: Acetyl-L-carnitine
Interferons
Ribavirin
Hepatitis C
Fatigue
Lead sponsor: University of Catania
Sponsor class: OTHER
First posted: 2013-07-26
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the effects of Acetyl-L-Carnitine, probiotics and antioxidant nutritional substances administration on work productivity, daily activity, and fatigue in subjects with chronic hepatitis C treated with Pegylated-Interferon-α2b and Ribavirin.


Eligibility criteria: Inclusion Criteria:

* Eligible patients are workers who are 18 years of age or older, infected by HCV with a quantifiable serum HCV RNA level (as determined by polimerase chain reaction, COBAS AmpliPrep/COBAS TaqMan - ROCHE). HCV infected populations must have elevated serum alanine transaminase levels and findings on liver biopsy consistent with chronic infection. Cirrhotic patients have to have a Child-Pugh score less than 7 to be eligible.

Exclusion Criteria:

* Ineligible patients are those who had other liver diseases, as well as those who are affected by cancer, severe jaundice, pulmonary and renal chronic diseases, prostatic diseases, autoimmune diseases and diabetes mellitus. Excessive use of alcohol (\>20 g/die) or hepato-toxic drugs. Other causes of exclusion include decompensated cirrhosis, pregnancy, and contraindications for Peg-IFN-a or RBV therapy such as cardiopathy, hemoglobinopathies, hemocromatosis, major depression or other severe psychiatric pathological conditions.

Primary outcomes:
measure: Work performances
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Catania
country: Italy
facility: University of Catania, Cannizzaro Hospital
Study officials:
References:
Clinical trial NCT05470257: Randomized Control Trial: Elbow Extension Versus Flexion Cast in Proximal Half Both Bone Forearm Fractures
Official title: Randomized Control Trial: Elbow Extension Versus Flexion Cast in Proximal Half Both Bone Forearm Fractures
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Fracture of Radius and Ulna
Keywords: both bone forearm fracture
cast
pediatric
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2022-07-22
Enrollment: 75
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two cohorts will be established. One will include patients casted in elbow extension. The other cohort will include patients casted in elbow flexion.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare outcomes between two immobilization methods for pediatric proximal half both bone forearm fractures.

Detailed description: After being informed of the study including potential risks and benefits, all patients giving assent and guardian/parents consent who meet eligibility will undergo randomization of the casting technique used (elbow extension or elbow flexion casting). Randomization will occur using a random umber generator. Even numbers generated will result in an extension cast and odd numbers generated will result in a flexion cast.

The patients will be followed in clinic with an examination and x-rays at 2, 3, 5, and 8 weeks after casting to evaluate alignment of the fracture maintained by each cast. The two cohorts will be compared at the end of the study to determine which casting technique is the superior immobilization for pediatric proximal half both bone forearm fractures.

Eligibility criteria: Inclusion Criteria:

* Ages 3-18
* Skeletally immature
* Unilateral Radius and Ulna Fracture located within the proximal ½ of each bone
* Fracture requires reduction and casting

Exclusion Criteria:

* Ages \< 3
* Distal ½ Radius and Ulna Forearm Fracture
* Isolated radius or ulna fracture
* Humerus Fracture of the Ipsilateral Arm (including floating elbow)
* Metabolic Bone Disease
* Open Fractures
* Monteggia and Galeazzi Fractures
* Deformity or abnormality not allowing for standard casting (limb deficiency, contracture)
* Parent speaks language other than english

Primary outcomes:
measure: Alignment/Loss of Reduction
timeFrame: This will be accessed in clinic via x-rays until 8 weeks status post cast application.
Secondary outcomes:
measure: Cast Complications
timeFrame: Casting complications will be followed the full duration of the patient wearing a cast, which is expected to be around 6-8 weeks.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Children's of Alabama
state: Alabama
Study officials:
References:
Clinical trial NCT03238157: Steroids for Early Treatment of Radiation Retinopathy
Official title: Steroids for Early Treatment of Radiation Retinopathy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Radiation Retinopathy
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2017-08-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized to either observation (2:1) (standard of care) or intravitreal Fluocinolone Acetonide (FA) implant
Primary purpose: TREATMENT

Brief summary: Radiation retinopathy is a known complication of ocular radiation therapy. To date there is no known effective treatment. In addition to their anti-vascular endothelial growth factor (VEGF) properties, corticosteroids decrease the retinal capillary permeability by increasing the activity/density of tight junctions and acute inflammatory effects of radiation in various tissues.

Detailed description: The purpose of the project is threefold:

1. To study the natural history of radiation retinopathy using advanced imaging techniques. A combination of macular OCT to evaluate for edema, OCT angiography to evaluate for macular and peri-papillary ischemia and wide-field angiography for peripheral ischemia and leakage. Potential role of OCT angiography in radiation retinopathy will be evaluated by comparison to other eye (control) and FA.
2. Currently there is no consensus on effective management strategy for radiation retinopathy. Patients in the interventional will be prospectively followed to study efficacy of steroids for early treatment of radiation retinopathy while comparing the multimodal therapeutic approach in a randomized trial.
3. Patients in the observational arm will be prospectively followed while comparing the multimodal therapeutic approach in a randomized trial.

Eligibility criteria: Inclusion Criteria:

* Primary uveal melanoma
* Primary treatment with plaque brachytherapy
* Baseline visual acuity 20/200 or better
* Posterior tumor margin \>1.50 mm from the center of the macula
* Posterior tumor margin \> 1.50 mm from the closest disc margin
* Calculated total dose to center of the macula \>40 Gy

Exclusion Criteria:

* Iris melanoma
* Opaque media
* less than 21 years of age
* Inability to give consent
* Positive pregnancy test

Primary outcomes:
measure: Central subfield retinal thickness by OCT scan
timeFrame: 24 months
Secondary outcomes:
measure: Best corrected visual acuity
timeFrame: 24 months
Other outcomes:
measure: Need for standard of care intervention
timeFrame: 24 months
Locations:
city: Cleveland
country: United States
facility: Cole Eye Instiute
state: Ohio
Study officials:
References:
Clinical trial NCT05297357: Complementary Weaning With Adult Food Typical of the Mediterranean Diet
Official title: Complementary Weaning With Adult Food Typical of the Mediterranean Diet and it Effect on Taste Development and Eating Habits of Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weaning
Keywords: Complementary feeding
Mediterranean Diet
Microbioma
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2022-03-28
Enrollment: 394
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A Randomized Controlled Clinical Trials was conducted to study the medium-long term impact of a complementary weaning using adult foods typical of Mediterranean Diets (MD) on children taste development and eating habits, and on the microbiota composition.

Main objectives were to assess the effect of such weaning scheme on:

1. medium-long term adherence of the children to the MD (Primary aim).
2. familial eating habits to verify how many changes may come from an early education of the kid toward a Mediterranean eating style
3. the BMI of the children
4. gut microbiota composition


Eligibility criteria: Inclusion Criteria:

* Infants, either breast fed or formula fed between 4 and 6 months of age
* Informed consent from at least one parent

Exclusion Criteria:

* Infants either with associated comorbidities or with low birth weight

Primary outcomes:
measure: Proportions of children showing a good adherence (i.e. KidMed score >= 8) to Mediterranean diet
timeFrame: 36 months
Secondary outcomes:
measure: Average of the KidMed score
timeFrame: 36 months
measure: Average children's BMI
timeFrame: 36 months
measure: Proportion of overweight and obese children
timeFrame: 36 months
measure: Variation of microbial communities between arms based on Bray-Curtis dissimilarity
timeFrame: 48 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00890357: Identifying Factors Underlying the Discontinuation of Triptans
Official title: Identifying Factors Underlying the Discontinuation of Triptans
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine
Medication Adherence
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2009-04-29
Enrollment: 292
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: Adult Specialty Headache Clinics

Brief summary: The objective of this study is to identify reasons migraine patients stop using triptan medications for abortive headache treatment. It is hypothesized that inadequate education of the patient at the time of prescribing the triptan is positively associated with triptan discontinuation.


Eligibility criteria: Triptan User Inclusion Criteria:

* Episodic Migraine or Chronic Migraine
* Have used a triptan medication in the prior 3 months
* Have used triptan medications for at least 1 year

Triptan Discontinuation Inclusion Criteria:

* Episodic Migraine or Chronic Migraine
* Used any triptan medication in the last 2 years
* Have not used a triptan medication in the last 6 months

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida College of Medicine
state: Florida
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: Mayo Clinic
name: Todd Schwedt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wells RE, Markowitz SY, Baron EP, Hentz JG, Kalidas K, Mathew PG, Halker R, Dodick DW, Schwedt TJ. Identifying the factors underlying discontinuation of triptans. Headache. 2014 Feb;54(2):278-89. doi: 10.1111/head.12198. Epub 2013 Sep 3.
Clinical trial NCT06718257: Chemotherapy Combined with Immunotherapy and Targeted Therapy in Cholangiocarcinoma
Official title: Chemotherapy Combined with Immunotherapy and Targeted Therapy in Advanced Intrahepatic Cholangiocarcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cholangiocarcinoma
Keywords: advanced cholangiocarcinoma
chemotherapy combined with immunotherapy and targeted therapy
clinical efficacy and safety
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2024-12-05
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients were histologically or radiologically confirmed intrahepatic cholangiocarcinoma, with initial treatment consisting of GP/GEMOX or GP/GEMOX combined with PD-1/L1 and TKI inhibitors.

Brief summary: This study aims to validate the efficacy and safety of GP/GEMOX combined with PD-1/L1 inhibitors and TKI agents in patients with advanced cholangiocarcinoma through a multicenter, retrospective study to guide clinical practice.

Detailed description: This study plans to enroll patients diagnosed with advanced cholangiocarcinoma. After confirming patients treated with GP/GEMOX or GP/GEMOX combined with PD-1/L1 and TKI agents as initial therapy, the investigators will collect relevant clinical data, including basic clinical information, laboratory data, imaging data, pathological data, and surgical data through an electronic medical record system.

Eligibility criteria: Inclusion Criteria:

* Histologically or radiologically confirmed intrahepatic cholangiocarcinoma
* Initially treated with GP/GEMOX or GP/GEMOX combined with PD-1/L1 and TKI inhibitors

Exclusion Criteria:

* Direct surgery after hospitalization
* Initial treatment combined with local therapies (radiotherapy, radiofrequency, particle implantation, TACE, etc.)
* Initial treatment involving other comprehensive therapeutic regimens

Primary outcomes:
measure: Overall survival (OS)
timeFrame: 1 year
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: 1 year
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Department of Hepatobiliary and Pancreatic Surgery, Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Weilin Wang, PHD
role: STUDY_CHAIR
References: