louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03996382: Prevalence of Wild Type Transthyretin Cardiac Amyloidosis in Patients Operated for Idiopathic Carpal Tunnel Syndrome
Official title: Prevalence of Wild Type Transthyretin Cardiac Amyloidosis in Patients Operated for Idiopathic Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amyloidosis Cardiac
Carpal Tunnel Syndrome
Lead sponsor: Aarhus University Hospital Skejby
Sponsor class: OTHER
Collaborators: name: Regional Hospital Holstebro
First posted: 2019-06-24
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Wild-type transthyretin cardiac amyloidosis is an underdiagnosed depository disease in which fibril monomers of misfolded amyloid protein accumulates in various tissues, including the heart, and cause tissue dysfunction.

Before onset of cardiac symptoms, many patients will have undergone surgery for idiopathic carpal tunnel syndrome since the protein also deposits in the transversal carpal ligament of the hand.

This study investigates patients previously operated for idiopathic carpal tunnel syndrome to determine if they display signs and symptoms of cardiac amyloidosis.


Eligibility criteria: Inclusion Criteria:

* Patients above sixty years of age previously operated for idiopathic carpal tunnel syndrome within the Region of Central Denmark (Region Midtjylland) the last five years.
* Informed written and verbal consent

Exclusion Criteria:

* Operation by different indication such as

  * Fracture
  * Ganglion
  * Tumors
  * Osteophytes
  * Rheumatoid Arthritis
  * Persistent medial artery
  * Metabolic causes
* Alcoholism
* Hyperthyroidism
* Myxedema

  * Hereditary Cardiac Amyloidosis
  * Known WT ATTR
  * AL Amyloidosis
  * Myelomatosis
  * MGUS and Morbus Waldenström

Primary outcomes:
measure: Prevalence of cardiac amyloidosis.
timeFrame: Through study completion, an average of 2 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Heart Disease
Study officials:
References:
Clinical trial NCT02164682: The Effect of Caudal Block on the Postoperative Complications in Pediatric Patients After Hypospadias Repair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypospadias
Keywords: Hypospadias repair
Caudal block
Postoperative complications
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-06-16
Enrollment: 404
Sex: MALE
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric patients who underwent the first hypospadias surgery at our institution between January, 2010 and December, 2014 (for 5 years).

Brief summary: Hypospadias refers to a disease represented by a congenital defect in the urethra meatus (urinary opening) in male children. Due to the postoperative pain, symptoms such as discomfort, agitation, and restlessness are generally found. In particular, young children with restlessness often express their pain or discomfort with their bodies because they are unable to express it in words. This severe restlessness may make an operated region unstable, accompanying bleeding, infection, or other surgery-related complications. Because postoperative pain control is very important, neuraxial block techniques such as epidural block or caudal block have been employed in addition to a penile dorsal nerve block. Although the neuraxial block technique including the caudal block is an easy and safe method and has an excellent effect, the neuraxial block technique poses a potential risk in the procedure. In addition, with respect to the surgical prognosis, it has been reported that penile engorgement may cause penile vasodilation, resulting in oozing at the surgical region or other surgical complications. However, there has not been a report on the increase of postoperative complications by penile vasodilation or on the difference in the recovery or surgical prognosis according to the types of pain control for young patients.


Eligibility criteria: Inclusion Criteria:

* Pediatric patients who underwent the tubularized incised plate (TIP) repair under hypospadias at our institution between January, 2010 and December, 2014

Exclusion Criteria:

* Patients whose medical records could not be analyzed for having undergone the first hypospadias surgery at another institution. Other exclusion criteria were as follows: over the age of 8 years, planned two-stage hypospadias repair, receiving continuous epidural analgesia, and without hypospadias as the final diagnosis.

Primary outcomes:
measure: The postoperative complications related hypospadias repair
timeFrame: within 6 months after hypospadias repair
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University Health System
Study officials:
References:
Clinical trial NCT05416320: Calcipotriol as a Novel Treatment for Central Centrifugal Cicatricial Alopecia (CCCA)
Official title: A Pilot Study of Calcipotriol as a Novel Treatment for Central Centrifugal Cicatricial Alopecia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Central Centrifugal Cicatricial Alopecia
Keywords: hair loss
hair follicle regrowth
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2022-06-13
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 10 patients for the study will be randomized to one of two groups who consent to participate in a novel treatment with calcipotriol, or the control (no additional treatment besides Subject's already prescribed drug)
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot study is to determine if calcipotriol shows potential to be an effective treatment for Central Centrifugal Cicatricial Alopecia (CCCA). This study aims to evaluate calcipotriol due to the possible anti-inflammatory effects that may affect the hair growth cycle.

Detailed description: Calcipotriol, a vitamin D analog, has been topically used to treat alopecia areata, a form of non-scarring autoimmune alopecia in several studies. It is possible that Vitamin D plays a role in sustaining the hair follicle's immune privilege through anti-inflammatory effects such as controlling Interferon gamma (IFN-γ) production. A recent study showed a significant decrease of vitamin D in Black patients with Central Centrifugal Cicatricial Alopecia (CCCA)"

Eligibility criteria: Inclusion Criteria:

* Women who are eighteen years of age or older
* biopsy-proven and/or clinical diagnosis of CCCA Stage II-IV
* must be on stable treatment without changes for at least 3 months
* Subjects will be recruited from outpatient dermatology clinics at the Wake Forest Baptist Health Department of Dermatology.

Exclusion Criteria:

* Males

Primary outcomes:
measure: Amount of hairline stabilization
timeFrame: Baseline
measure: Amount of hairline stabilization
timeFrame: Month 2
measure: Amount of hairline stabilization
timeFrame: Month 4
measure: Amount of hairline stabilization
timeFrame: Month 6
Secondary outcomes:
measure: Amount of hair regrowth
timeFrame: Baseline, Month 2, Month 4, and Month 6
measure: Signs and symptoms of disease score
timeFrame: Month 2, Month 4, and Month 6
measure: Dermatology Life Quality Index score
timeFrame: Baseline and Month 6
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Amy McMichael, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03831620: The Crosstalk Between Calcium-sensing Receptor Signaling and Endocannabinoid System in Primary Hyperparathyroidism
Official title: The Crosstalk Between Calcium-sensing Receptor Signaling and Endocannabinoid System in Primary Hyperparathyroidism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Hyperparathyroidism
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2019-02-06
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary hyperparathyroidism with planned surgery

Brief summary: Despite the strong association of hyperparathyroidism with arachidonic acid related lipid signals, little research has been performed over the years. A better understanding of the link between arachidonic acid remodeling, prostaglandin and endocannabinoid production with primary hyperparathyroidism in primary tissue/cells might open up new avenues for biomarker and thus to a potential therapeutic target.

Arachidonic acid remodeling might also have an impact on depression and elevated cytokines in patients with primary hyperparathyroidism. The investigators therefore will assess the correlation between postoperative improvement of PHQ-9 and cytokine levels with arachidonic acid remodeling.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Primary hyperparathyroidism with planned surgery
* Written informed consent

Exclusion Criteria:

* Age \<18 years
* Secondary/tertiary hyperparathyroidism
* Renal insufficiency
* Participant is pregnant
* Participant is incapable of giving an informed consent

Primary outcomes:
measure: Activity-based protein profiling (ABPP) will be used to assess the enzymes involved in calcium induced stress signals and endocannabinoid activation
timeFrame: 2 months
Secondary outcomes:
measure: Measurement of the level of parathyroid hormone
timeFrame: 2 months
measure: Measurement of the level of calcium
timeFrame: 2 months
measure: Measurement of the level of cortisol
timeFrame: 2 months
measure: Measurement of the level of 25-hydroxyvitamin D
timeFrame: 2 months
measure: Measurement of the levels of the enzymes involved in the endocannabinoid system activation (diacylglycerol lipase; monoacylglycerol lipase, phospholipases, cyclooxygenases)
timeFrame: 2 months
measure: Measurement of the level of endocannabinoids, arachidonic acid species, prostanoids and related anti-inflammatory lipids
timeFrame: 2 months
measure: Measurement of the level of IL-6 and TNF-α
timeFrame: 2 months
measure: Assessment of Patient Health Questionnaire - 9
timeFrame: 2 months
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of visceral surgery and transplant surgery, Berne University Hospital
Study officials:
affiliation: Insel Gruppe AG, University Hospital Bern
name: Reto Kaderli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02210520: Effect of Ultrasound and Laser in Chronic Low Back Pain: Randomized Double-blinded Controled Trial
Official title: Effect of Laser and Ultrasound in Pain and Disability in Women With Chronic Non-specific Low Back Pain: Randomized Double-blinded Controled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Low Back Pain
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2014-08-06
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The low level laser therapy has a better effect in decrease the pain than ultrasound therapeutic.

Detailed description: The laser will be applied with the dosimetry 3 J/cm², 2 minutes in 6 points around the back spine, during 4 weeks. Before the women will be evaluate again.

Eligibility criteria: Inclusion Criteria:

* chronic low back pain
* 3,0 - 7,0 in the visual analogic scale

Exclusion Criteria:

* no use of medications
* no other treatment
* without fractures, pregnancy, psychiatric or neurologic disorders, diabetes, amputations
* with diagnostic of low back pain

Primary outcomes:
measure: Pain intensity
timeFrame: 4 weeks
Secondary outcomes:
measure: Pain quality
timeFrame: 4 weeks
measure: Disability
timeFrame: 4 Weeks
Other outcomes:
Locations:
city: Porto Velho
country: Brazil
facility: São Lucas College
state: Rondõnia
Study officials:
affiliation: São Paulo University
name: Ana Paula A Rubira, master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01687920: Dose Proportionality Study With BAY94-8862 IR (Immediate Release) Tablets
Official title: Single Center, Randomized, Open-label, 5-fold Crossover Study in Healthy Male Subjects to Investigate the Pharmacokinetic Dose Proportionality of BAY94-8862 Given as 5 Different Single Oral IR Tablet Doses (1.25, 2.5, 5.0, 7.5 and 10 mg)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Heart Failure
Keywords: Cardiac disorders
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2012-09-19
Enrollment: 25
Sex: MALE
Minimum age (years): 18
Maximum age (years): 46
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study should estimate the dose proportionality of BAY94-8862 IR tablets.


Eligibility criteria: Inclusion Criteria:

* Healthy male subject
* Age: 18 to 46 years (inclusive) at the first screening examination
* Ethnicity: White
* Body mass index (BMI): \>= 18 and \<= 29.9 kg / m²

Exclusion Criteria:

* Clinically relevant findings in the ECG (electrocardiogram) such as a second- or third-degree AV block, prolongation of the QRS complex over 120 msec
* Systolic blood pressure below 100 or above 140 mmHg
* Diastolic blood pressure below 50 or above 90 mmHg
* Heart rate below 50 or above 95 beats/ min
* Positive results for hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), human immune deficiency virus antibodies (anti-HIV 1+2)
* Participation in another clinical study during the preceding 3 months (Last Treatment from previous study to First Treatment of new study)

Primary outcomes:
measure: Dose proportionality of BAY94-8862 exposure in plasma when given as 1.25, 2.5, 5.0, 7.5 and 10 mg IR tablets
timeFrame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 15, 24, 28 & 48 h
Secondary outcomes:
measure: Number of participants with adverse events as a measure of safety and tolerability of BAY94-8862
timeFrame: Up to 48 h
Other outcomes:
Locations:
city: Mönchengladbach
country: Germany
facility: CRS Clinical-Research-Services Mönchengladbach GmbH
state: Nordrhein-Westfalen
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05950620: Bringing Weight Management Into the Primary Care Pediatric Practice
Official title: Pilot and Feasibility Project to Establish a Childhood Nutrition and Health Clinic Managing Weight and Obesity Complications in a Primary Care Pediatric Practice
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity, Childhood
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: William H. Hurt Foundation
First posted: 2023-07-18
Enrollment: 400
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in a general pediatrician's office internally in Portland, Oregon.

Brief summary: This project aims to move what is currently a specialty-care model for the management of obesity of children and adolescents into the primary care setting.

Detailed description: The goal of this project is to create a sustainable clinical model in the primary care setting that improves nutritional health, lessens obesity, and addresses weight-related complications of children and adolescents to reduce risk for metabolic disease in later life. The primary objectives include tracking changes in BMI (both absolute and percentile) and levels of hemoglobin A1c, liver enzymes (AST, ALT levels), and lipids in patients seen in a primary care setting by a general pediatrician board-certified in obesity medicine. Secondary objectives include tracking patient adherence, follow-up, and retention.

Eligibility criteria: Inclusion Criteria:

Children with obesity (BMI \> 30 kg/m2 or \> 95th percentile) or in need of weight management of unwanted weight gain.

Exclusion Criteria:

None.

Primary outcomes:
measure: Change in body weight
timeFrame: Baseline to follow-up (1-3 years)
measure: Change in body height
timeFrame: Baseline to follow-up (1-3 years)
measure: Change in BMI
timeFrame: Baseline to follow-up (1-3 years)
measure: Impact on glucose control
timeFrame: Baseline to follow-up (1-3 years)
measure: Impact on fatty liver
timeFrame: Baseline to follow-up (1-3 years)
measure: Impact on lipid levels
timeFrame: Baseline to follow-up (1-3 years)
Secondary outcomes:
measure: Patient follow-up metrics
timeFrame: Baseline to follow-up (1-3 years)
Other outcomes:
Locations:
city: Portland
country: United States
facility: The Children's Clinic
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
References:
Clinical trial NCT00004420: Study of Gammalinolenic Acid for Juvenile Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Juvenile Rheumatoid Arthritis
Keywords: arthritis & connective tissue diseases
juvenile rheumatoid arthritis
rare disease
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
Collaborators: name: University of Massachusetts, Worcester
First posted: 1999-10-19
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

I. Determine the efficacy and safety of gammalinolenic acid in the treatment of childhood arthritis.

Detailed description: PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, cross over study of 12 months duration. Patients are stratified by type of juvenile rheumatoid arthritis (systemic onset vs pauciarticular disease vs polyarticular disease).

Patients are randomized to receive either gammalinolenic acid (GLA) or placebo (safflower seed oil) orally. Parents are asked to maintain the child's usual diet over the course of study.

Patients are followed at 3, 6, 9, and 12 months during study and at 6 months thereafter.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Juvenile rheumatoid arthritis (systemic onset, pauciarticular disease, and polyarticular disease)
* Active synovitis

--Prior/Concurrent Therapy--

* No more than 2 concurrent nonsteroidal antiinflammatory drugs
* No more than 2 concurrent second line agents (e.g., D-penicillamine, oral or injectable gold, antimalarials, methotrexate, sulfasalazine)
* Must have started second line agent at least 3 months prior to study
* Must be on stable doses of all medications for at least 1 month prior to study
* Prior prednisone allowed if started at least 3 months prior to study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Massachusetts, Worcester
name: Robert B. Zurier
role: STUDY_CHAIR
References:
Clinical trial NCT00044720: Study Evaluating Sirolimus in End Stage Renal Disease in High Risk Kidney Transplant Recipients
Official title: An Open-label, Concentration Controlled, Randomized, 12 Month Study of Prograf + Rapamune + Cor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Kidney Failure
Graft vs Host Disease
Kidney Transplantation
Keywords: Kidney Transplant
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2002-09-06
Enrollment: 484
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED

Brief summary: The incidence of efficacy failure at 12 months between two regimens.


Eligibility criteria: Inclusion Criteria

* Age: 13 years or older, 40 kgs or more
* End-stage renal disease
* African-American/Black transplant recipient and/or repeat renal transplant recipient who lost a previous allograft

Exclusion Criteria

* Evidence of active infection
* Evidence abnormal chest x-ray
* Patients with HIV.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04233320: Efficacy and Safety of Silicone Cream Containing Allium Cepa Extract
Official title: Efficacy and Safety of Silicone Cream Containing Allium Cepa Extract in Post-cesarean Surgical Scars Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cicatrix
Keywords: Scar
Allium Cepa
post-cesarean
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objectives of this study were to evaluate efficacy and safety of silicone cream containing Allium Cepa extract in post-cesarean surgical scars treatment. Post-cesarean surgical scars were equally seperated into 2 parts (left part and right part). Silicone cream containing Allium Cepa extract or commercial scar gel was ramdomly assigned to apply on left part or right part of the scar. They will be applied 2 times per day (morning and evening) for 3 months. Patient and Observer Scar Assessment Scale (POSAS) , Vancouver scar scale (VSS), melanin index, and erythema index (using cutometer) were used for scar evaluation at 0, 1,2,and 3 months. Moreover, adverse effects were also observed.


Eligibility criteria: Inclusion Criteria:

* Age 18-40 years
* Have Post-Cesarean Surgical Scars at least 1 month
* REEDA scale = 0 score
* Able to read and write Thai
* Able to follow the research plan
* Able to meet all the researchers throughout the period of participation in the project

Exclusion Criteria:

* Apply other topical application at the post-cesarean surgical scars within 2 weeks before participating in the study and during the study
* There is radiation in the area of the post-cesarean surgical scars
* Chronic skin diseases such as psoriasis, chronic dermatitis, allergies
* Immune deficient or use immunosuppressants within 2 weeks before participating in the study and during the study
* Have a history of silicone allergy or onion extract

Primary outcomes:
measure: Patient and Observer Scar Assessment Scale
timeFrame: 3 months
Secondary outcomes:
measure: Vancouver scar scale
timeFrame: 3 months
measure: Melanin index
timeFrame: 3 months
measure: Erythema index
timeFrame: 3 months
measure: Adverse effect
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References: