louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05175027: Preoperative Antiseptic in Newborn Circumcision Comparison of Povidone Iodine and Hypochlorous Acid Used
Official title: "Comparison of Povidone Iodine and Hypochlorous Acid Used as a Preoperative Antiseptic in Neonatal Circumcision"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Newborn; Infection
Disinfection
Circumcision
Keywords: circumcision,
wound
antibacterial
Lead sponsor: Hisar Intercontinental Hospital
Sponsor class: OTHER
First posted: 2022-01-03
Enrollment: 60
Sex: MALE
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Two models:Newborns to be circumcised randomly were divided into two groups as Hypochlorosis group and Povidone iodine group.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Comparison of Povidone iodine and Hypochlorous acid used as a Preoperative Antiseptic in Newborn Circumcision abstract

Aim:

Circumcision is one of the most common surgical procedures in all age groups. Before the circumcision procedure, asepsis is provided with a surface disinfectant. Various methods can be used for this process. Povidone iodine, which has been used for years during the transition from traditional circumcision methods to surgical circumcision methods; tissue damage, allergic reactions and increase in pain level. For this reason, the investigators aimed to compare it with Hypochlorous acid (Crystalin), which is a less toxic and more physiological antiseptic solution.

Material and Method:

Newborns to be circumcised randomly were divided into two groups as Hypochlorosis group and Povidone iodine group. At the beginning of the circumcision procedure, a culture was taken in the form of a prepucial swab 1 minute after the cleaning of the local area and the inner surface of the prepuce. Then circumcision was performed. Culture results and complications were compared.

Detailed description: It is aimed to compare two solutions used for cleaning the operation area in newborn circumcision.It was conducted to compare the antibacterial activity of povidone iodine and hypochlorous.

Eligibility criteria: Inclusion Criteria:

* male
* newborn,

Exclusion Criteria:

* hipospadias,
* epispadias,
* urinary infectious

Primary outcomes:
measure: The effect of both drugs on wound healing will be investigated.
timeFrame: one month
measure: The effect of both drugs on antibacterial effects will be investigated
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Hisar Intercontinental Hospital
Study officials:
affiliation: Hisar Intercontinental Hospital
name: Basri Cakiroglu
role: STUDY_DIRECTOR
References:
Clinical trial NCT02285127: Short Versus Long Cephalomedullary Nailing of Pertrochanteric Hip Fractures: A Randomized Prospective Study
Official title: Short Versus Long Cephalomedullary Nailing of Pertrochanteric Hip Fractures: A Randomized Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pertrochanteric Hip Fracture
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2014-11-06
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Is there a functional outcome difference when treating pertrochanteric fractures with a short or long cephalomedullary nail?


Eligibility criteria: Inclusion criteria

* AO/OTA fracture classification 31(A-B) (1-3).
* Age greater than 18 years old.

Exclusion Criteria

-Less than 18 years old.

Primary outcomes:
measure: SF (short form)-36
timeFrame: 3 months
Secondary outcomes:
measure: Harris Hip Score
timeFrame: 3 months
Other outcomes:
measure: Reoperation
timeFrame: within 1 year
measure: Mortality
timeFrame: 1 year
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Stephen Sems, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03820427: Evaluation of Novel Lung Function Parameters in Patients With Bronchial Asthma
Official title: Evaluation of Novel Lung Function Parameters in Patients With Bronchial Asthma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchial Asthma
Pulmonary Healthy Controls
Lead sponsor: Universitätsmedizin Mannheim
Sponsor class: OTHER
First posted: 2019-01-29
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with indication for routine lung function testing

Brief summary: Current guideline-based criteria defining bronchial asthma do not always meet the challenges set by the complex pathophysiology of the disease. The investigators therefore aimed to evaluate novel or not widely used functional diagnostic approaches for the detection and therapeutic monitoring of patients with asthma.


Eligibility criteria: Inclusion Criteria:

* known or suspected bronchial asthma
* known or suspected obstructive ventilation disorder
* pulmonary healthy controls

Exclusion Criteria:

* pregnancy
* inability to participate

Primary outcomes:
measure: Global ventilation heterogeneity
timeFrame: 30 minutes
measure: Local ventilation heterogeneity
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00686127: Symptom Management After Breast Cancer Surgery
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial (RDBPCT) of the Effectiveness of the Lidocaine Patch in the Management of Neuropathic Pain After Breast Cancer Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neuropathic Pain
Postmastectomy Pain
Keywords: breast cancer
neuropathic pain
topical lidocaine
postmastectomy pain
breast symptoms
breast pain
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2008-05-29
Enrollment: 21
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This trial is part of a larger, longitudinal study of symptoms that occur in the breast surgical scar area and/or ipsilateral arm following breast cancer surgery. Women who develop pain in the breast scar area or ipsilateral arm will be randomized to a placebo patch or a lidocaine patch that they will wear on a daily basis for 12 weeks. We hypothesize that women who wear the lidocaine patch will report a decrease in pain and decreased interference with function compared to women who wear the placebo patch.


Eligibility criteria: Inclusion Criteria:

* Adult women \>18 years who develop neuropathic pain in the breast scar area and/or ipsilateral arm following breast cancer surgery
* Has a healed incision(s)
* Has no recurrent disease in the painful area
* Is able to read, write and understand English

Exclusion Criteria:

* Presence of another type of pain that is more severe than the neuropathic pain
* Use of an opioid analgesic of greater than 60 mg codeine/day
* Is actively trying to become pregnant
* Has a medical contraindication to the use of lidocaine
* Has an allergy to lidocaine
* Is taking a coanalgesic for neuropathic pain.

Primary outcomes:
measure: Change in Pain Intensity on an 11-point Scale From Baseline to 12 Weeks
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Pain Interference With Function
timeFrame: 12 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Comprehensive Cancer Center
state: California
Study officials:
References:
Clinical trial NCT00697827: A Study of the In-Space Device for Treatment of Moderate Spinal Stenosis
Official title: A Multi-Center Randomized Controlled Trial of the In-Space Compared to X STOP® for Treatment of Moderate Degenerative Lumbar Spinal Stenosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Spinal Stenosis
Lead sponsor: Synthes USA HQ, Inc.
Sponsor class: INDUSTRY
First posted: 2008-06-16
Enrollment: 44
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of the In-Space compared to the X STOP Interspinous Process Distraction (IPD) device ("X STOP") for the treatment of patients experiencing intermittent neurogenic claudication secondary to moderate degenerative lumbar stenosis at one or two lumbar levels.


Eligibility criteria: Inclusion Criteria:

* ≥ 50 years in age
* Leg/buttock/groin pain, with or without back pain, that can be completely relieved by flexion such as when sitting in a chair.
* Zurich Claudication Questionnaire Score ≥ 2.0,
* Neurogenic intermittent claudication secondary to moderate lumbar spinal stenosis
* Has completed at least 6 months conservative therapy

Exclusion Criteria:

* Axial back pain only without leg/buttock/groin pain
* Has had any prior lumbar spine surgery at any level
* Significant scoliosis, defined as Cobb angle \> 10°
* Spondylolisthesis \> Grade 1 or isthmic spondylolisthesis at affected level
* Osteoporosis
* Morbid obesity, defined as BMI \> 40 kg/m2

Primary outcomes:
measure: Zurich Claudication Questionnaire(ZCQ)
timeFrame: 24 months
Secondary outcomes:
measure: Oswestry Disability Index (ODI)
timeFrame: 24 months
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: The Spine Institute
state: California
city: New Haven
country: United States
facility: Yale Orthopedics
state: Connecticut
city: Minneapolis
country: United States
facility: Institute for Low Back and Neck Care
state: Minnesota
city: New York
country: United States
facility: Cornell University Hospital
state: New York
city: Charlotte
country: United States
facility: OrthoCarolina Spine Center
state: North Carolina
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Nashville
country: United States
facility: Neurosurgical Associates at Centennial Medical Center
state: Tennessee
city: Plano
country: United States
facility: Texas Back Institute
state: Texas
city: Norfolk
country: United States
facility: Neurosurgical Specialists, Inc.
state: Virginia
city: Tacoma
country: United States
facility: Madigan Army Medical Center
state: Washington
Study officials:
References:
Clinical trial NCT02530827: Energy Expenditure of People Living With HIV/AIDS
Official title: Influence of Lipid-lowering Drugs in Patients Seropositive for HIV With Lipodystrophy in Resting Energy Expenditure and Total Energy Expenditure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV/AIDS
HIV Lipodystrophy Syndrome
Keywords: energy expenditure
doubly labeled water
accelerometer
HIV
lipodystrophy syndrome.
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2015-08-21
Enrollment: 45
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Men previously diagnosed with HIV infection, on antiretroviral therapy.

Brief summary: Background: Several studies have reported increased resting energy expenditure (REE) in people living with HIV/AIDS possibly due to changes in body composition that occurs in HIV lipodystrophy syndrome.

The aim of this study was to evaluate the influence of the use of lipid-lowering drugs in resting energy expenditure (REE) and total energy expenditure (TEE) in patients seropositive for HIV in treatment of lipodystrophy.

Detailed description: REE was measured by indirect calorimetry.

TEE was measured by doubly labeled water (DLW) technique and an activity monitor based on accelerometry (AM).

Eligibility criteria: Inclusion Criteria:

* Use of antiretroviral therapy for at least 4 months
* A cluster of differentiation 4 (CD4) T-cell count of \>200 cells/mm3
* Use of lipid-lowering drugs for at least 1 month (group HIV-seropositive with lipodystrophy and use of lipid-lowering)

Exclusion Criteria:

* Signs or symptoms of opportunistic infections
* Thyroid disease

Primary outcomes:
measure: Total Energy Expenditure (kcal/d)
timeFrame: 14 day
measure: Resting Energy Expenditure (kcal/d)
timeFrame: 1 day
Secondary outcomes:
measure: Correlation between doubly labeled water and accelerometer to measure total energy expenditure (ICC, 95% CI)
timeFrame: 14 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05570227: Metabolic Phenotypes in Melanoma
Official title: Identification of Metabolic Phenotypes Associated With Prognosis and Therapeutic Response in Patients With Melanoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Melanoma
Keywords: Metabolism
Lead sponsor: Peter MacCallum Cancer Centre, Australia
Sponsor class: OTHER
First posted: 2022-10-06
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This is a single centre, correlative, longitudinal, biomarker study that aims to describe the metabolic features of human melanoma using mass spectrometry.

Detailed description: This is a single-centre, correlative study designed to investigate metabolic phenotypes in a longitudinal cohort of patients with melanoma. This study will involve the collection of tissue at the time of surgical excision or biopsy. The key intervention, in a subset of patients, will be to perform peri-operative infusions of a stable isotope, \[U13C\]Glucose. Patients will be intravenously administered sterile, pyrogen-free 13C-glucose, delivered as an 8g bolus followed by infusion of 4g/hour for 2-3 hours. Blood samples will be obtained to monitor glucose and to analyse enrichment of labelled nutrients by gas-chromatography mass spectrometry (GC-MS). At the time of resection or biopsy, tumour samples will be divided and either immediately frozen in liquid nitrogen or processed to form patient-derived xenografts. Frozen tumour samples will be subsequently processed for: isotope enrichment by GC-MS; global metabolomics by liquid-chromatography mass spectrometry (LC-MS); and genomic analyses. Relevant clinical, histologic and genomic features will also be correlated with metabolic findings.

Eligibility criteria: Inclusion Criteria:

1. Patient has provided written informed consent
2. Male or female aged 18 years or older at written informed consent
3. Presence of a known melanoma lesion requiring surgical excision or biopsy
4. Patient is willing and able to comply with the protocol for the duration of the study including undergoing biopsies and receiving a stable isotope infusion (where applicable)

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from receiving a \[U-13C\]Glucose infusion:

1. Diabetes mellitus
2. Pregnancy or breast feeding
3. Patients unable to comply with study procedures and follow up in the opinion of the investigator

Primary outcomes:
measure: Glucose Utilisation in the TCA cycle
timeFrame: 5 years
measure: Lactate Utilisation in the TCA cycle
timeFrame: 5 years
Secondary outcomes:
measure: Relapse free survival
timeFrame: 5 years
measure: Overall Survival
timeFrame: 5 years
Other outcomes:
measure: Tumour Metabolomic and Lipidomic Profiling
timeFrame: 5 years
Locations:
city: Melbourne
country: Australia
facility: Peter Mac Callum Cancer Centre
state: Victoria
Study officials:
affiliation: Peter MacCallum Cancer Centre, Australia
name: Aparna Rao, MBBS PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02322073: Inflammation and Obesity-associated Disease
Official title: Inflammation and Obesity-associated Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity
Inflammation
Kidney Disease
Liver Disease
Metabolic Syndrome
Cardiometabolic Syndrome
Fibrosis
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Vastra Gotaland Region
First posted: 2014-12-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Obese individuals planned for Roux-en-Y gastric bypass or Sleeve gastrectomy surgery and lean healthy controls planned for elective benign laparoscopic surgery.

Brief summary: Visceral obesity and adipose inflammation is considered a driving force of obesity-related systemic disease, e.g. cardiometabolic disease, liver cirrhosis and chronic kidney disease (CKD). Inflammatory resolution is actively regulated by specialized pro-resolving mediators (SPMs), including the endogenous eicosanoid LXA4. Impairment of SPMs may underlie development of obesity-related pathology.We hypothesize that obese patients who develop obesity-related disease do so because they suffer from impaired endogenous production of pro-resolving lipids. This will result in aggravated adipose inflammation and fibrosis, which contribute to the systemic pathologies. We thus wish to investigate adipose inflammation and the pro-resolving lipid profile of obese subjects with and without obesity associated metabolic disease. We also aim to investigate whether LXA4, LXB4 and other anti-inflammatory agents (such as AICAR) can alter the phenotype of human adipose macrophages in ex vivo tissue culture. We also investigate basic pathways in inflammatory regulation and obesity related cardiometabolic disease.


Eligibility criteria: Inclusion Criteria:

* Obese BMI 35-55 kg/m2
* Lean BMI 18.5-24.9

Exclusion Criteria:

* Medical treatment with NSAIDs, corticosteroid treatment, immune-suppressants.
* Other: smoking, alcohol abuse.

Primary outcomes:
measure: Inflammatory status
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahglrenska University Hospital
Study officials:
References:
citation: Borgeson E, Wallenius V, Syed GH, Darshi M, Lantero Rodriguez J, Biorserud C, Ragnmark Ek M, Bjorklund P, Quiding-Jarbrink M, Fandriks L, Godson C, Sharma K. AICAR ameliorates high-fat diet-associated pathophysiology in mouse and ex vivo models, independent of adiponectin. Diabetologia. 2017 Apr;60(4):729-739. doi: 10.1007/s00125-017-4211-9. Epub 2017 Feb 10.
Clinical trial NCT01618773: Long-term Study of Epiduo in Patients With Moderate to Severe Acne
Official title: Epiduo in the Long-term Treatment of Moderate to Severe Acne With or Without Concomitant Medication
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acne Vulgaris
Keywords: acne
Epiduo
adapalene/ benzoyl peroxide
Lead sponsor: Galderma Laboratorium GmbH
Sponsor class: INDUSTRY
First posted: 2012-06-13
Enrollment: 6036
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: About 6,650 patients with moderate to severe acne (Leeds grade 4-12)

Brief summary: This observational study is designed to assess the long-term efficacy and safety of Epiduo (alone or in combination with other drugs) under daily clinical practice conditions in patients with moderate to severe inflammatory acne. In addition, the effect of Epiduo on quality of life and patient adherence will be assessed under marketed conditions.

Detailed description: This observational study is designed to assess the long-term efficacy and safety of Epiduo under daily clinical practice conditions. The study includes patients of all ages with moderate to severe inflammatory acne, taking Epiduo alone or in combination with other drugs. In addition, the effect of Epiduo alone or in combination with other drugs on quality of life and patient adherence will be assessed under marketed conditions.

The observational study is designed as a multicentre study, covering all parts of Germany. Participating investigators are dermatologists with an adequate patient pool of acne patients. The observation time per patient will be 9 months. An interim and final examination with subsequent documentation are designated to be performed about 3 and 9 months after the start of treatment, respectively.

Eligibility criteria: Inclusion Criteria:

* The patient has been diagnosed with moderate to severe inflammatory acne (Leeds Grade 4-12)
* Topical therapy of acne with Epiduo is indicated, the decision about treating the patient with Epiduo has been made independently from this study

Exclusion Criteria:

* Use of Epiduo within 3 months prior to inclusion
* Pregnancy or breastfeeding
* Acne inversa
* Acne with preferential manifestation of microcysts, macrocysts and macrocomedones
* Hypersensitivity to the drug or any of its ingredients
* If applicable, other restrictions outlined in the SPC of Epiduo

Primary outcomes:
measure: Severity of acne
timeFrame: at baseline and after 3 and 9 months treatment
Secondary outcomes:
measure: Quality of Life
timeFrame: at baseline and after 3 and 9 months of treatment
measure: Treatment adherence
timeFrame: after 3 and 9 months of treatment
measure: Local Skin Irritations
timeFrame: over 9 months
Other outcomes:
Locations:
Study officials:
affiliation: Universitätsklinikum Magdeburg A.ö.R. Klinik für Dermatologie und Venerologie
name: Harald PM Gollnick, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: