louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01836848: Non-invasive Measuring of Cerebral Perfusion After Severe Brain Injury With Near-infrared-spectroscopy and ICG
Official title: Continuous, Non-invasive Monitoring of Cerebral Oxygenation and Perfusion Using Near-infrared Spectroscopy With Indocyanine Green Perfusion Measurement in Patients With Traumatic Brain Injury, Intracerebral or Subarachnoid Hemorrhage
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Subarachnoid Hemorrhage, Aneurysmal
Intracerebral Hemorrhage (ICH)
Traumatic Brain Injury
Keywords: subarachnoid hemorrhage
near-infrared-spectroscopy
indocyanine green
secondary ischemia
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2013-04-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to show if it is possible to detect secondary ischemic events in patients with severe brain injury or cerebral haemorrhage with the help of non-invasive near-infrared spectroscopy (NIRS) by using the indocyanine green measuring of cerebral perfusion.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years
* onset of clinical symptoms of subarachnoid or intracranial haemorrhage or trauma suffered less than 72h
* indication for implanting a tissue oxygen and intracranial pressure probe
* A signed informed consent by the patient or legal guardian

Exclusion Criteria:

* Persistent epidural, subdural or subcutaneous hematoma in planned area of the NIRS optode
* Open injuries in the area of the planned optodes
* Malignant primary disease under chemotherapy
* pregnancy
* bleeding disorder
* In the short term unfavorable prognosis (eg, bilateral wide and light-fixed pupils)
* Patients with pacemakers or where no MRI compatibility is due to non- removable metal parts
* contraindications for contrast media in CT (eg, iodine allergy)
* Untreated hyperthyroidism
* End Stage Renal Disease
* severe psychomotor agitation

Primary outcomes:
measure: with near-infrared-spectroscopy detected cerebral perfusion deficit
timeFrame: 15 days after ictus
Secondary outcomes:
measure: Determining a threshold value for cerebral autoregulation measured with near-infrared-spectroscopy as a predictive value for the clinical outcome
timeFrame: 15 days after ictus and follow up 6 month later
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Departement of General Neurosurgery of th University of Cologne
Study officials:
affiliation: Universitiy of Cologne, Departement of General Neurosurgery
name: Gerrit Brinker, physician
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04154748: Argon Plasma Coagulation for Barrett's Esophagus
Official title: Argon Plasma Coagulation for Barrett's Esophagus With Low Grade Dysplasia: A Randomized Trial With Long Term Follow-up Evaluating the Impact of Power Setting and Proton Pump Inhibitor Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Barretts Esophagus With Low Grade Dysplasia
Keywords: Barretts Esophagus
Dysplasia
Argon Plasma Coagulation
Endoscopic Treatment
Lead sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
Sponsor class: OTHER
Collaborators: name: Centre of Postgraduate Medical Education
First posted: 2019-11-06
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Investigator initiated, single-center, parallel-group RCT conducted in a tertiary referral center in Poland.
Primary purpose: TREATMENT

Brief summary: Background and study aims. To evaluate the impact of power setting and proton pump inhibitor (PPI) dose on the efficacy and safety of argon plasma coagulation (APC) of Barrett's esophagus (BE) with low-grade dysplasia (LGD).

Patients and methods. Investigator initiated, single-center, parallel-group randomized controlled trial (RCT) conducted in a tertiary referral center in Poland. Consecutive patients with BE and LGD were randomly assigned to APC with power set at 90 Watt (90W) or 60 Watt (60W) followed by 120 mg or 40 mg omeprazole for six weeks. The primary outcome of the study was the rate of complete (endoscopic and histologic) ablation of BE at six weeks. Secondary outcomes included safety and long-term efficacy (at two years and at the end of a long-term follow-up of over 4 years.


Eligibility criteria: Inclusion Criteria:

* consecutive adult patients with low-grade dysplasia in flat Barrett's mucosa referred for endoscopic treatment,
* signed an informed consent to participate in the study.

Exclusion Criteria:

* high-grade dysplasia or adenocarcinoma,
* visible lesions (nodules, ulcerations) in Barrett's mucosa,
* serious comorbidities and short life expectancy,
* coagulopathy,
* pregnancy or lactation,
* psychiatric disorders.

Primary outcomes:
measure: Complete ablation rate 6 weeks after APC treatment.
timeFrame: 6 weeks
Secondary outcomes:
measure: Adverse event rate during APC treatment and within 6-week post-treatment period
timeFrame: 6 weeks
measure: Complete ablation rate two years after APC treatment
timeFrame: 2 years
measure: Complete ablation rate at the end of follow-up
timeFrame: Long term follow-up (>4 yars)
Other outcomes:
Locations:
Study officials:
References:
citation: Wronska E, Polkowski M, Orlowska J, Mroz A, Wieszczy P, Regula J. Argon plasma coagulation for Barrett's esophagus with low-grade dysplasia: a randomized trial with long-term follow-up on the impact of power setting and proton pump inhibitor dose. Endoscopy. 2021 Feb;53(2):123-132. doi: 10.1055/a-1203-5930. Epub 2020 Jul 10.
Clinical trial NCT00997048: Comparison Between Laying Open and Sinus Excision of Pilonidal Sinus - a Randomized Study
Official title: Comparison Between Laying Open and Sinus Excision of Pilonidal Sinus - a Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pilonidal Sinus
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2009-10-16
Enrollment: 80
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: A pilonidal sinus is a cyst or abscess near or on the natal cleft of the buttocks that often contains hair and skin debris. The condition is common and requires surgery to be cured. Several surgical procedures are described in literature. The most common surgical procedure in Sweden is excision of the sinus followed by suturing the subcutaneous tissue and skin. This method, however, has some problems regarding healing and recidives. Therefore this study is comparing the standard excision procedure to another surgical procedure, laying open. Healing frequency is the main variable, but postoperative pain, sick leave time and patient satisfaction is also measured.


Eligibility criteria: Inclusion Criteria:

* Pilonidal sinus eligible for surgery
* Age \> 18 years
* Swedish speaking

Exclusion Criteria:

* Active signs of infection prohibiting primary sewing of the wound

Primary outcomes:
measure: Healing frequency
timeFrame: 12 months
Secondary outcomes:
measure: pain according to a visual analogue scale
timeFrame: 7 days
measure: scar/wound length
timeFrame: 12 months
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University Hospital, surgery
Study officials:
affiliation: Uppsala University
name: Wilhelm Graf, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lorant T, Ribbe I, Mahteme H, Gustafsson UM, Graf W. Sinus excision and primary closure versus laying open in pilonidal disease: a prospective randomized trial. Dis Colon Rectum. 2011 Mar;54(3):300-5. doi: 10.1007/DCR.0b013e31820246bf.
Clinical trial NCT03001648: Cumulative Live Birth Rates in Patients With Repeated Implantation Failure (RIF) Undergoing Preimplantation Genetic Screening (PGS )
Official title: Cumulative Live Birth Rates in Patients With Repeated Implantation Failure (RIF) Undergoing Preimplantation Genetic Screening (PGS )
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Preimplantation Genetic Screening
Lead sponsor: Fundacion Dexeus
Sponsor class: OTHER
First posted: 2016-12-23
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Repeated implantation failure patients: patients \<39 years old that have received at least 4 day 3 good quality embryos or 2 good quality blastocists with no implantation.

Brief summary: This is a single centre retrospective study in repeated implantation failure patients: \< 39 years old, at least 4 D3 good quality embryos or 2 good quality blastocysts transferred without implantation, absence of known causes of implantation failures (uterine malformation, thrombophilia, severe male factor, uncontrolled thyroid disfunction, autoimmune disease).

Patients scheduled for PGS underwent one or more stimulation cycles (oocyte or blastocyst banking) in order to maximize chances of embryo transfer. PGS cycles are analyzed globally. Aditionally, PGS cycles with a single stimulation cycle are analyzed in comparison to standard IVF cycles.


Eligibility criteria: Inclusion criteria:

* women \< 39 years
* repeated implantation failure: at least 4 day 3 good quality embryos or 2 good quality blastocysts transferred without implantation

Exclusion criteria:

* partner with severe male factor, or abnormal sperm Fluorescence in situ hybridization (FISH) analysis
* presence of uni or bilateral hydrosalpinx, uterine malformation, thrombophilia, uncontrolled thyroid disfunction or autoimmune disease

Primary outcomes:
measure: Cumulative live birth rate
timeFrame: at 24 months of first embryo transfer
Secondary outcomes:
measure: Clinical Pregnancy Rate
timeFrame: 6 weeks after embryo transfer
measure: Implantation Rate
timeFrame: 6 weeks after embryo transfer
measure: Miscarriage Rate
timeFrame: Until 20 weeks after embryo transfer
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus
Study officials:
References:
Clinical trial NCT06379048: The Impact of Different Skin Suture Methods in Episiotomy Repair on Healing and Pain
Official title: The Impact of Different Skin Suture Methods in Episiotomy Repair on Healing and Pain: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor; Prolonged, Second Stage
Episiotomy Wound
Keywords: Labor
Vaginal Birth
Episiotomy
Suturing
Lead sponsor: Başakşehir Çam & Sakura City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-04-23
Enrollment: 132
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Episiotomy is the intentional incision of the perineum during vaginal birth in order to accelerate the active phase of labor. This study aimed to compare various skin closure techniques in episiotomy repair.


Eligibility criteria: Inclusion Criteria:

* Primiparous
* Age between 18 to 45
* Given birth in our labor ward

Exclusion Criteria:

* Multiparous
* having deep vaginal lacerations
* having abnormalities in fetus
* Rheumatologic diseases
* Postpartum bleeding
* Shoulder Dystocia
* Operative Delivery
* Using antithrombotic or anticoagulant medications

Primary outcomes:
measure: Healing by Redness, Edema, Ecchymosis and Discharge (REEDA) Score
timeFrame: in postpartum day 15
measure: Pain by Visual Analog Scale (VAS)
timeFrame: in postpartum day 15
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Cam and Sakura City Hospital
state: Basaksehir
Study officials:
References:
citation: Yuksel S, Ustun A, Kar E, Ozcan A, Callioglu N. The impact of different skin Suture methods in episiotomy repair on healing and pain: A randomized clinical trial. Health Care Women Int. 2025 May 5:1-15. doi: 10.1080/07399332.2025.2499498. Online ahead of print.
Clinical trial NCT00310648: Comparative Trial Evaluating Safety and Immunogenicity of an Adjuvanted and a Conventional Influenza Vaccine in Elderly Subjects (> 60 Years)
Official title: Part 1:Phase I Open-Label, Single-Center to Evaluate the Safety of a Commercially Available Adjuvanted Influenza Vaccine When Administered to Elderly Subjects Part 2: A Phase III, Randomized, Controlled, Observer-Blind, Single-Center Study to Evaluate the Immunogenicity and Safety of a Commercially Available Influenza Vaccine and a Conventional Commercially Available Influenza Vaccine When Administered to Elderly Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: Influenza, elderly, vaccine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Novartis Vaccines
name: Chiron s.r.l. Beijing Representative Office
First posted: 2006-04-04
Enrollment: 600
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Clinical Trial in Two parts:

Part 1: Phase I, Open-Label, Single-Center Study to Evaluate the Safety of an adjuvanted Influenza Vaccine When Administered to Elderly Subjects.

Part 2: A Phase III, Randomized, Controlled, Observer-blind, Single-Center Study to Evaluate the Immunogenicity and Safety of an adjuvanted and a conventional Influenza Vaccine When Administered to Elderly Subjects.


Eligibility criteria: Inclusion Criteria:

* Subjects 60 years of age or older, mentally competent, willing and able to give the written informed consent prior to study entry

Exclusion Criteria:

* Any serious disease such as: cancer, autoimmune disease, advanced arteriosclerotic disease or complicated diabetes mellitus, chronic obstructive pulmonary disease (COPD) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure.
* Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine.
* History of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine.
* Known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age).

Primary outcomes:
measure: Requirements For Drug Registration & Guide Principles For ClinicaL Trial Techniques of Vaccine e.g Seroprotection, GMR's and Seroconversion rate at day 21 following vaccination.
Secondary outcomes:
measure: Solicited Local and Systemic Reactions Within 6 Days Following Vaccination And Adverse Events Thought the Study.
Other outcomes:
Locations:
city: Guangxi
country: China
facility: Nanning
Study officials:
affiliation: Novartis Vaccines & Diagnostics
name: Novartis Vaccines - Drug Information Services
role: STUDY_DIRECTOR
References:
citation: Li R, Fang H, Li Y, Liu Y, Pellegrini M, Podda A. Safety and immunogenicity of an MF59-adjuvanted subunit influenza vaccine in elderly Chinese subjects. Immun Ageing. 2008 Feb 20;5:2. doi: 10.1186/1742-4933-5-2.
Clinical trial NCT01804348: AL-SENSE 1-Step - Determination of Product Specificity
Official title: AL-SENSE 1-Step - Determination of Product Specificity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: PREMATURE RUPTURE OF MEMBRANES
Keywords: PROM
Lead sponsor: Common Sense
Sponsor class: OTHER
First posted: 2013-03-05
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Clinical diagnosis of amniotic fluid leak will be determined, according the hospital standard procedure, using pooling test and/or sterile speculum examination and /or pH test, and AmniSure, N-Dia, Inc. (immunoassay for diagnosis of ruptured fetal membranes (ROM)). Amniotic fluid leak test, using the AL- SENSE 1-Step device, will be considered positive in case of presence of a blue or green or grey stain on a yellow background of the AL-SENSE 1-Step, as observed by the patient and the clinician (positive/negative).

Detailed description: Pregnant women arriving at the hospital and reporting unidentified wetness (undetermined whether they sense amniotic fluid leakage or urinary incontinence) will receive a single AL-SENSE 1-Step to use up to 12 hours or until they notice any wetness. The clinician will explain the proper use and handling of the AL-SENSE 1-Step and how to read the result.

In each case, the subject and the clinician/midwife (non bias to the hospital standard procedure results) will be required to read and record any occurrence of color change of the AL-SENSE 1-Step immediately after removing the test to mark if it changes color to blue or to green or to grey on the designated form.

The non bias physician, who is not aware to the AL-SENSE 1-Step result (other than the clinician/midwife who records the AL-SENSE 1-Step results) will perform a diagnosis tests for amniotic fluid leak detection, according to the hospital standard procedure.

The investigator will compare the AL-SENSE 1-Step results reading of the patient to the clinical diagnosis.

Eligibility criteria: Inclusion Criteria:

1. AgE 18 years OR GREATER.
2. Subject who will sign the informed consent form.
3. Subject who arrive at the obstetric department reporting a feeling of vaginal wetness feeling (undetermined whether she sense amniotic fluid leakage or urinary incontinence).

Exclusion Criteria:

1. Subjects that have had sexual relations within the last 12 hours.
2. Subject is unable or unwilling to cooperate with study procedures.
3. Subject is currently participating in another clinical study

Primary outcomes:
measure: amniotic fluid leaks
timeFrame: up to 12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Nahariya
country: Israel
facility: Western Galilee Hospital
Study officials:
affiliation: Western Galilee Hospital Nahariya, Israel
name: Jacob Bornstain, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03938948: Low Level Light Therapy (LLLT) for Hair Growth
Official title: The Efficacy of Visible Red Light for Promoting the Growth of Human Scalp Hair for Both Male and Female - An Open-label Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Male Pattern Baldness
Female Pattern Baldness
Lead sponsor: Awareable Technologies Inc
Sponsor class: INDUSTRY
First posted: 2019-05-06
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A total of 62 participants will receive red light (660 nm) to the scalp through a specially designed light therapy device integrated into a conventional hat. Each treatment will be 30 min per session applied on every other day for 14 weeks.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects between the ages of 18 and 60 years
* Diagnosed AGA in the past 12 months for male (Fitzpatrick I-IV, Hamilton-Norwood IIa-V ) and female (Fitzpatrick I-IV, and Ludwig-Savin Baldness Scale I-2, I-3, I-4, II-1, II-2 baldness patterns)

Exclusion Criteria:

* Known Photosensitivity
* Using any oral or topical substance for hair growth
* Having Tattoo, hair transplantation, scalp reduction, malignancy or hair weave in the scalp are with alopecia
* Known medical conditions that could negatively affect hair growth, such as infections, connective tissue disease
* Currently or plan to be on a calorie-restricted diet during study participation

Primary outcomes:
measure: Hair Density
timeFrame: 14 weeks
measure: Hair Density
timeFrame: 14 weeks
Secondary outcomes:
measure: Hair Follicle Change
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Ijamsville
country: United States
facility: Will Surgical Arts
state: Maryland
Study officials:
name: Michael Will, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01948648: Effects of Fish Oil and Colesevelam (STAIR7007)
Official title: Effects of Fish Oil, Colesevelam and Combination Therapy on Sterol Metabolism in Sitosterolemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sitosterolemia
Keywords: plant sterols
cholesterol
colesevelam
phytosterolemia
fish oil
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2013-09-23
Enrollment: 13
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: If treatment of colesevelam, fish oil in conjunction with ezetimibe, will lead to further reduction in plasma plant sterol levels in sitosterolemia patients. We hypothesize that treatments with fish oil, colesevelam and ezetimibe will maximize decrease in plasma concentrations of sitosterol and other plant sterols in sitosterolemia patients.

Detailed description: Ezitimibe significantly lowers plant sterol levels in the blood of patients with sitosterolemia. However, plant sterol levels remain substantially elevated compared to those in healthy individuals. Thus, combination therapy needs to be considered. Agents that provide cardiovascular benefits such as colesevelam, a second-generation bile acid sequestrant, and fish oil are potential candidates to help further reduce sterol levels, but have yet to be evaluated in sitosterolemia patients.

The purpose of this study is to dtermine the effects of colesevelam, fish oil and combination therapy (fish oil + colesevelam) on plant sterols, cholesterol and cardiovascular risk factors in sitosterolemia patients treated with ezetimibe. The results of this study will enhance knowledge on the pathogenesis of sitosterolemia and the mechanisim of actions of colesevelam and fish oil as adjunct therapies to ezitimibe in patients with the disease.

Eligibility criteria: Inclusion Criteria:

1. Confirmed diagnosis of homozygous sitosterolemia as established by genotyping and/or clinical parameters
2. Receiving ezetimibe treatment
3. Over 8 years of age (no maximum)
4. Concomitant illnesses or conditions

Exclusion Criteria:

1. Pregnancy
2. Intellectual disability
3. Bowel or biliary obstruction
4. Known hypersensitivity to colesevelam or any ingredients of colesevelam

Primary outcomes:
measure: Plasma plant sterol level
timeFrame: 32 weeks
Secondary outcomes:
measure: Fatty acid
timeFrame: 32 weeks
measure: endothelial functions
timeFrame: 32 weeks
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Richardson Center for Functional Foods and Nutraceuticals
state: Manitoba
Study officials:
References: