louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00417768: Safety and Effectiveness of tPA in Intra-abdominal Abscesses
Official title: Safety and Effectiveness of Local Instillation of tPA in the Management of Complex Intra-abdominal Fluid Collections: a Randomized, Double Blinded Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Abscess
Keywords: tissue plasminogen activator
intraabdominal
abscess
percutaneous drainage
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2007-01-04
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine if instillation of tissue plasminogen activator into a percutaneously drained intra-abdominal abscess cavity results in faster resolution of the abscess compared to normal standard of care.

Detailed description: On day 0 Subjects will have Tissue Plasminogen Activator injected into a drainage tube and allowed to dwell in the intra-abdominal abscess for one hour before allowing it to drain by gravity. This will be repeated on day 1 and 2.

Eligibility criteria: Inclusion Criteria:

* Intrabdominal abscess

Exclusion Criteria:

* Hypersensitivity to tPA
* Recent stroke
* Uncontrolled htn
* Recent major hemorrhage
* Pregnancy

Primary outcomes:
measure: time to eating
measure: time to discharge
measure: radiological evidence of resolution
Secondary outcomes:
measure: cost comparison
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network - University of Toronto
name: Dheeraj Rajan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lakeridge Health Science Center
name: Murray Asch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004368: Phase I Study of Colchicine Therapy in Childhood Hepatic Cirrhosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Cirrhosis
Liver Cirrhosis
Keywords: hepatic cirrhosis
gastrointestinal disorders
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: Children's Hospital Colorado
First posted: 1999-10-19
Enrollment: 15
Sex: ALL
Minimum age (years): 0
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

I. Investigate the efficacy and safety of colchicine therapy in improving hepatic function and reducing hepatic fibrosis (scarring) in children with hepatic cirrhosis.

Detailed description: PROTOCOL OUTLINE: Patients receive colchicine orally twice daily for 24 months. After the first month, the dose of colchicine will increase and remain at that dose for the duration of study.

Patients are evaluated every 6 months during study.

Eligibility criteria: * Advanced hepatic fibrosis or cirrhosis in children
* Not pregnant

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Children's Hospital Colorado
name: Ronald J. Sokol
role: STUDY_CHAIR
References:
Clinical trial NCT05021068: Spinal Structure and Mobility in Chronic Obstructive Pulmonary Disease
Official title: Investigation of The Relationship Between Spinal Structure and Mobility and Respiratory Functions in Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Postural; Defect
Respiratory Function Impaired
Dyspnea
Keywords: copd
posture
respiratory function
dyspnea
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
First posted: 2021-08-25
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD patients over 18 years old

Brief summary: In recent studies with musculoskeletal system disorders in chronic respiratory patients, it has been reported that postural control is affected in COPD patients.

The aim of this study to investigate relationship between spinal structure and mobility an severity of dyspnea in patients with COPD.

Detailed description: Chronic Obstructive Pulmonary Disease (COPD) is a preventable and treatable disease characterized by irreversible airway limitation. In recent studies with musculoskeletal system disorders in chronic respiratory patients, it has been reported that postural control is affected in COPD patients.It has been observed that balance systems, functional balance tests, posturography, posture assessment systems, force platform and inclinometer measurements are used in studies on postural control assessment in COPD patients.There are a limited number of studies in which devices that objectively present the degree of deviation in spinal curves are used in patients with COPD, and posture and lung volume and capacities are evaluated.

Therefore, the aim of this study is to investigate the changes in spine structure and mobility in COPD patients and to reveal their relationship with static and dynamic lung volumes and capacities.

Eligibility criteria: Inclusion Criteria:

* Volunteer to participate in the study
* Be over 18 years old
* Being clinically stable
* Not having a COPD attack in the last 3 months at least

Exclusion Criteria:

* Refusing to participate in the research
* Having had spinal surgery Presence of back and shoulder pain
* Idiopathic scoliosis
* Ankylosing spondylitis
* Presence of respiratory disease other than COPD
* Difficulty understanding verbal commands

Primary outcomes:
measure: Spinal Structure and Mobility
timeFrame: 15 minutes (single application)
Secondary outcomes:
measure: Pulmonary Functions
timeFrame: 10 minutes (single application)
measure: Dyspnea Severity
timeFrame: 5 minutes (single application)
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Dr. Suat Seren Chest Diseases and Surgery Training and Research Hospital
Study officials:
References:
Clinical trial NCT00005968: Irofulven in Treating Patients With Stage IV Melanoma
Official title: A Multicenter Phase II Trial of MGI-114 in Patients With Stage IV Malignant Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Melanoma (Skin)
Keywords: stage IV melanoma
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-06-21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of irofulven in treating patients who have stage IV melanoma.

Detailed description: OBJECTIVES: I. Determine the response rate and duration of response in patients with stage IV malignant melanoma treated with 6-hydroxymethylacylfulvene. II. Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients receive 6-hydroxymethylacylfulvene IV over 5 minutes on days 1-5. Treatment repeats every 4 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease after completion of course 2 receive additional courses. Patients are followed every 3 months for 5 years, and then annually thereafter until death.

PROJECTED ACCRUAL: Approximately 16-35 patients will be accrued for this study within 1 year.

Eligibility criteria: DISEASE CHARACTERISTICS: Histologically proven stage IV malignant melanoma No prior chemotherapy OR No more than 1 prior chemotherapy containing regimen Measurable disease Brain metastasis allowed if adequately treated

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 OR Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Hemoglobin at least 10 g/dL WBC at least 4,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) ALT/AST no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 50 mL/min Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: See Disease Characteristics Recovered from any prior therapy No other concurrent therapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: John Wayne Cancer Institute
state: California
city: Denver
country: United States
facility: Veterans Affairs Medical Center - Denver
state: Colorado
city: Denver
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Park Ridge
country: United States
facility: Lutheran General Hospital
state: Illinois
city: Columbia
country: United States
facility: Ellis Fischel Cancer Center - Columbia
state: Missouri
Study officials:
affiliation: University of Colorado, Denver
name: Rene Gonzalez, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04369768: Restoration of Permanent Molars Affected With Molar-incisor-hypomineralization (MIH) Among a Group of Egyptian Children Using Composite Restorations or Preformed Metal Crowns
Official title: Restoration of Permanent Molars Affected With Molar-incisor-hypomineralization (MIH) Among a Group of Egyptian Children Using Composite Restorations or Preformed Metal Crowns: Two-arm Randomized Controlled Trial (Part I)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Molar Incisor Hypomineralization
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-04-30
Enrollment: 60
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the clinical outcome of using direct esthetic composite restorations and the use of preformed metal crowns in managing MIH cases among a group of Egyptian children.


Eligibility criteria: Inclusion Criteria:

* Children with MIH in one fully erupted molar or more.
* Age ranging from 7-12 years.
* Cooperative children
* Good general health.

Exclusion Criteria:

* patients participating in other experiments.
* Patients with parents planning to move away within the following year.
* Patients with only mildly affected MIH molars that do not require extensive restorative treatment.
* MIH-affected molars that have a very poor prognosis and require extraction.
* First permanent molars that are affected with other developmental defects, such as hypoplasia, dental fluorosis or amelogenesis imperfecta

Primary outcomes:
measure: treating hypersensitivity associated with MIH affected permanent molars by questioning the patient
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01765868: A Human Phase I Absolute Bioavailability Study of PRT054021 in Healthy Male Volunteers
Official title: A Human Phase I Absolute Bioavailability Study of PRT054021 in Healthy Male Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: Betrixaban
Healthy
Bioavailability
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2013-01-10
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This is a open label, single center, single oral dose, study of PRT054021, in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy adult men ages of 19 and 65 years old, inclusive
* BMI of 18-35 kg/m2

Exclusion Criteria:

* Clinically significant comorbid disease
* History of substance abuse

Primary outcomes:
measure: Percent of orally absorbed dose
timeFrame: over 72 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03689868: Limited-English Proficiency (LEP) Virtual Reality (VR) Study
Official title: Addressing Parental and Pediatric Anxiety Through Virtual Reality (VR) Intervention in (Limited-English Proficiency) LEP Populations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Parents
Language
Keywords: virtual reality
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2018-10-01
Enrollment: 44
Sex: ALL
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine if non-invasive distracting devices (Virtual Reality headset) are more effective than the standard of care (i.e., no technology based distraction) for preventing anxiety in parental and pediatric populations with limited English proficiency (LEP).


Eligibility criteria: Inclusion Criteria:

* Ages 0-99 (Child participants will be ages 0 to 17. Parents of children of any age may also be enrolled)
* Able to consent
* Self-identified as having a limited English proficiency or English-proficiency

Exclusion Criteria:

* People who do not consent
* Significant Cognitive Impairment
* History of Severe Motion Sickness
* Current Nausea
* Seizures
* Visual Problems
* Patients whose children are clinically unstable or require urgent/emergent intervention

Primary outcomes:
measure: Procedural-Related Anxiety
timeFrame: Duration of intervention, approximately 20-30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital Stanford
state: California
Study officials:
References:
citation: West AM, Bittner EA, Ortiz VE. The effects of preoperative, video-assisted anesthesia education in Spanish on Spanish-speaking patients' anxiety, knowledge, and satisfaction: a pilot study. J Clin Anesth. 2014 Jun;26(4):325-9. doi: 10.1016/j.jclinane.2013.12.008. Epub 2014 Jun 2.
citation: Fabiyi C, Rankin K, Norr K, Shapiro N, White-Traut R. Anxiety among Black and Latina Mothers of Premature Infants at Social-Environmental Risk. Newborn Infant Nurs Rev. 2012 Sep 1;12(3):132-140. doi: 10.1053/j.nainr.2012.06.004.
Clinical trial NCT05134168: LIFT With or Without Injection of BM-MNCs
Official title: Ligation of Intersphincteric Fistula Tract (LIFT) With or Without Injection of Bone Marrow Mononuclear Cells in Treatment of Trans-sphincteric Anal Fistula; a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anal Fistula
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2021-11-24
Enrollment: 70
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: To improve the outcome of LIFT, some authors used a combined approach of LIFT. Pooled analysis of seven studies including 192 patients revealed a success rate of 83.5 % after combined LIFT approach. The use of bone marrow aspirate concentrate (BMAC) in surgery is not entirely new as it has been widely used in the treatment of bone defects, mandibular reconstruction, maxillary sinus augmentation and in critical limb ischemia.

A previous study concluded that the use of BMAC to augment external anal sphincter repair strengthens wound healing by transferring cells responsible for healing directly to the site of repair. The current study aimed to assess the outcome of local injection of bone marrow mononuclear cells (BM-MNCs) in conjunction with LIFT as compared to LIFT alone in regards to healing rate, time to healing, and ultimate success rate.


Eligibility criteria: Inclusion Criteria:

* Adult patients of either gender presented with cryptoglandular trans-sphincteric anal fistula

Exclusion Criteria:

* Patients with secondary anal fistula
* Immunocompromised patients
* Patients with previous pelvic radiotherapy
* Pregnant women
* Patients with ASA (American society of anesthesiologists) III or higher.

Primary outcomes:
measure: Number of patients with complete healing of anal fistula as assessed by clinical examination
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura university hospital
state: Dakahlia
Study officials:
References:
Clinical trial NCT01453868: The Effects of Aerobics Training on Balance in Patients With Multiple Sclerosis
Official title: The Effects of Neuromuscular Training on Balance in Patients With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Multiple Sclerosis
non impact aerobics
Lead sponsor: Nelson Mandela Metropolitan University
Sponsor class: OTHER
First posted: 2011-10-18
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Standing Balance, with and without blindfold, will be measured on patients with Multiple Sclerosis using a Biodex Balance Scale.

A Twelve week intervention with one non impact aerobics group and one control group will be performed.

Standing balance will then be retested on all subjects and the results will be statistically compared.

Detailed description: Standing Balance will be tested in 4 phases:

* On a firm surface eyes open
* On a frim surface eyes blindfolded
* On a foam surface eyes open
* On a foam surface eyes blindfolded

The aerobics classes will be conducted by a NIA (Non Impact Aerobics) instructor and will be a combination of tai chi, slow movement dancing, stretching and modified yoga stretches.

Eligibility criteria: Inclusion Criteria:

* Patients that were diagnosed by a neurologist with Relapsing Remitting Multiple Sclerosis.
* EDSS scale between 1 and 6.
* Patients that are able to travel to and from a 12 week program location.

Exclusion Criteria:

* Patients that were diagnosed by a neurologist with primary or secondary progressive multiple sclerosis.
* EDSS scale above 6

Primary outcomes:
measure: Biodex Scale Balance score: Automated
timeFrame: Change: baseline and 12 weeks
Secondary outcomes:
measure: Pre and post intervention questionaire
timeFrame: Change: baseline and 12 weeks
Other outcomes:
Locations:
city: Gaylord
country: United States
facility: HealthZone Chiropractic Clinic
state: Michigan
Study officials:
affiliation: Nelson Mandela Metropole University, Department of Health Sciences
name: Donovan Adendorf, DC
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor: Human Movement Sciences, NMMU-Port Elizabeth South Africa
name: Rosa DuRandt, PhD
role: STUDY_DIRECTOR
affiliation: Faculty of Helath Sciences-NMMU, Port Elizabeth South Africa
name: Maryna Baard, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03631368: Treatment of Hypertrophic Scars With Intradermal Botox
Official title: Treatment of Hypertrophic Scars With Intradermal Botox
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hypertrophic Scar
Lead sponsor: Laser and Skin Surgery Center of New York
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2018-08-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, open label, single center, self-controlled clinical study to demonstrate the safety and efficacy of intradermal botulinum toxin in treating hypertrophic scarring.


Eligibility criteria: Inclusion Criteria:

1. Healthy female and male subjects between the ages 18-75.
2. Non-Smoker.
3. Fitzpatrick skin type I-VI.
4. Desire to improve hypertrophic scarring.
5. Able and willing to comply with all visit, treatment and evaluation schedules and requirements.
6. Able to understand and provide written Informed Consent.

Exclusion Criteria:

1. Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
2. Presence of any active systemic or local infections.
3. Presence of active local skin disease that may alter wound healing.
4. Known allergy to botulinum toxin.
5. History of smoking in past 10 years.
6. History of chronic drug or alcohol abuse.
7. Inability to understand the protocol or to give informed consent.
8. History of cosmetic treatments in the area to be treated, including injectable filler of any type within the past year; Botox in the treatment area within the past 6 months; ablative or non-ablative resurfacing/rejuvenation laser treatment or light treatment within the past 6 months, dermabrasion or deep peels within the past 6 months; surgery to the area within the past 6 months.
9. History of intralesional corticosteroids or any other injectable medication to the area within the last 3 months.
10. History of topical corticosteroids to the area within the past 4 weeks.
11. History of any musculoskeletal disease or any weakness in the area to be treated.
12. As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

Primary outcomes:
measure: Improvement of hypertrophic scars based on the Subject and Observer Scar Assessment Scale
timeFrame: change from baseline at 6 months after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Laser & Skin Surgery Center of New York
state: New York
Study officials:
References: