louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02914756: HMGB1 in ICU-survivors
Official title: Cognitive Impairment After Critical Illness, Links Between Sepsis, Cognitive Function and Non-resolving Inflammation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Cognitive Impairment
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2016-09-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients being treated at Karolinska University Hospital Intensive Care Unit

Brief summary: Is HMGB1 (High Mobility Group Box 1) elevated in sepsis patients for weeks after recovery from severe sepsis/septic shock, similar to what has been observed in mice? Do patients recovering from severe sepsis/septic shock suffer from cognitive impairment and is such impairment associated with prolonged HMGB1 levels in plasma? Is there a difference from patients recovering from critical illness without prior sepsis?


Eligibility criteria: Inclusion Criteria:

* Male/Female age 18-17
* Expected ICU-stay more than 24 hours

Exclusion Criteria:

* Dont understand the language
* Substance abuse, alcohol or drugs
* Blind, deaf or suffering from aphasia
* Ongoing psychiatric illness or psychopharmacological treatment
* Suffering from dementia och mentally impaired
* Structured brain damage or meningitis
* Palliative Care
* ICU-treated for more than 48 hours
* Transferred from other ICU
* Being treated with ECMO
* Not having residency in Stockholm

Primary outcomes:
measure: Is HMGB1 elevated in sepsis patients for weeks after recovery from severe sepsis/septic shock, similar to what has been observed in mice?
timeFrame: 2 years
measure: Do patients recovering from severe sepsis/septic shock suffer from cognitive impairment and is such impairment associated with prolonged HMGB1 levels in plasma? Is there a difference from patients recovering from critical illness without prior sepsis?
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Dept of Anesthesiology, Surgical Services and Intensive Care Medicine, Karolinska University Hospital
Study officials:
References:
citation: Bruck E, Svensson-Raskh A, Larsson JW, Caravaca AS, Gallina AL, Eberhardson M, Sackey PV, Olofsson PS. Plasma HMGB1 levels and physical performance in ICU survivors. Acta Anaesthesiol Scand. 2021 Aug;65(7):921-927. doi: 10.1111/aas.13815. Epub 2021 Mar 27.
Clinical trial NCT05575856: Cardiogenic Shock Registry Mannheim
Official title: Cardiogenic Shock Registry Mannheim - CARESMA
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiogenic Shock
Keywords: cardiogenic shock
heart failure
cardiac arrest
shock
acute myocardial infarction
Lead sponsor: Universitätsmedizin Mannheim
Sponsor class: OTHER
First posted: 2022-10-12
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes all patients presenting with a cardiogenic shock at the intensive care unit (ICU).

Brief summary: The study aims to investigate clinically and prognostically relevant parameters in patients with cardiogenic shock within a monocentric observational clinical register.

Detailed description: All consecutive patients with a confirmed cardiogenic shock presenting at the internal intensive care Unit (ICU) at the University of Mannheim are included in the register and followed up during ICU stay and after that. Data of patients' admission status, cause of cardiogenic shock, baseline parameters and comorbidities are collected. Extensive information about echocardiography, electrocardiography and imaging procedures are included in the register. Laboratory values, microbiological investigations, organ dysfunction and organ replacement therapies, medication, adverse events, and complications were recorded for several days during the ICU stay (days 1, 2, 3, 5, 7, and 8). Standard scores for critically ill patients were calculated for the day of admission at the ICU if available, and several time points during the ICU stay. The register includes information about the mortality during ICU stay, 30-day mortality, 6-month mortality and 1-year mortality.

Eligibility criteria: Inclusion Criteria:

* Cardiogenic shock according to current guidelines

Exclusion Criteria:

* other forms of shock not primary associated with cardiac dysfunction

Primary outcomes:
measure: all-cause mortality
timeFrame: 30 days
Secondary outcomes:
measure: all-cause mortality
timeFrame: during hospital stay (up to 30 days)
measure: all-cause mortality
timeFrame: 1 years
measure: ventilator-free days
timeFrame: 30 days
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: First Department of Medicine, University Medical Centre Mannheim
Study officials:
References:
Clinical trial NCT05804656: Efficacy and Safety of CKDB-501A in Subjects With Moderate-to-severe Glabellar Lines in Phase 3 Trial
Official title: A Randomized, Double-blind, Active-controlled, Multi-center Phase 3 Trial to Investigate the Efficacy and Safety of CKDB-501A in Subjects With Moderate-to-severe Glabellar Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glabellar Lines
Lead sponsor: CKD Bio Corporation
Sponsor class: INDUSTRY
First posted: 2023-04-07
Enrollment: 300
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Randomized, Double-blind, Active-controlled, Multi-center Phase 3 Trial to Investigate the Efficacy and Safety of CKDB-501A in Subjects with Moderated-to-severe Glabella Lines


Eligibility criteria: Inclusion Criteria:

1. Subjects with at least moderate glabellar lines at maximum frown as determined by severity score of at least 2-point (moderate) on the Facial Wrinkle Scale (4-point FWS) as assessed by investigator.

Exclusion Criteria:

1. Any medical condition that can affect the neuromuscular function
2. History of facial nerve paralysis or ptosis
3. Significant facial asymmetry
4. Subjects whose glabellar lines cannot be sufficiently improved by physical method
5. Subjects who have a previous surgical history that could result in any anatomical changes related to corrugator muscle, procerus muscle, or any relevant nerves
6. Subjects with skin abnormalities at potential injection sites

Primary outcomes:
measure: Proportion of subjects with a ≥ 2-point improvement on the FWS score at maximum frown from baseline, as assessed by the investigator post-administration of the investigational product
timeFrame: Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
Study officials:
affiliation: Chung-Ang University Hosptial
name: Beomjoon Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02630056: Validate the Dosimetric Parameters That Correlate With Acute Hematologic Toxicity (HT) in Patients With Rectal Cancer
Official title: Validate the Dosimetric Parameters That Correlate With Acute Hematologic Toxicity (HT) in Patients With Rectal Cancer Treated With Neoadjuvant Chemoradiotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rectal Neoplasm
Keywords: radiotherapy hematologic toxicity pelvic bone marrow
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2015-12-15
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Both gender is OK and there is no limitation for age.

Brief summary: The purpose of this study is to validate the dosimetric parameters that correlate with acute hematologic toxicity (HT) in patients with rectal cancer treated with neoadjuvant chemoradiotherapy.

Detailed description: The investigators' ongoing retrospective study investigated the clinical and dosimetric parameter (dosimetry of pelvic bone marrow) which relate with acute hematologic toxicity in patient with rectal cancer treated with neoadjuvant chemoradiotherapy. In order to validate the dosimetric limitation of pelvic bone marrow in decreasing the intensity of HT, the investigators want to conduct a study to observe the acute HT without assigning any specific interventions to the subjects of the study, who will receive the standard treatment according to the multidisciplinary team's (MDT) decision and patient choice. Therefore, this study's type is observational.

Eligibility criteria: Inclusion Criteria:

* rectal cancer
* receive neoadjuvant chemoradiotherapy

Exclusion Criteria:

* hematological system disorders

Primary outcomes:
measure: the grade of acute hematologic toxicity
timeFrame: 5-6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05097456: Carbon Dioxide Acupulse Laser Treatment Versus Sham Treatment and Stress Urinary Incontinence Symptoms
Official title: Randomized, Double-blind, Sham-controlled Clinical Trial for Evaluating the Efficacy of Fractional Carbon Dioxide Laser in the Treatment of Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2021-10-28
Enrollment: 125
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is intended to assess the safety and efficacy of Carbon dioxide AcuPulse laser treatment in patients with stress urinary incontinence. Eligible subjects will be randomized to either receive 3 laser or 3 sham treatment sessions, 4 weeks apart and 3 follow up visits 3, 6 and 12 months following the last treatment.

Detailed description: Following a screening visit, eligible subjects will be enrolled into the study. Subjects will be randomized into either laser treatment or sham treatment. Each subject will receive 3 treatments 4 weeks apart and 3 follow up visits, at 3, 6 and 12 months following the last treatment.

Further demographic information and patient history will be obtained from the subjects' electronic files.

Eligibility criteria: Inclusion Criteria:

* Negative urine analysis.
* Normal Pap smear test from the recent 3 years.
* No previous gynecological laser treatments.
* Able and willing to comply with the treatment/follow-up schedule and requirements.

Exclusion Criteria:

* Active genital infection.
* Subject presenting abnormal Pap result from the last three years.
* Recurring urinary tract infection or recurring infection of genital herpes or candida (\> 2 episodes in the recent year).
* Transvaginal mesh implant.
* Serious systemic disease or any chronic condition that could interfere with study compliance.
* Any vaginal bleeding of unknown reason.

Primary outcomes:
measure: Pad weight test
timeFrame: From treatment up to 12 months post treatment
Secondary outcomes:
measure: Cough test
timeFrame: From treatment up to 12 months post treatment
measure: Urinary distress index questionnaire
timeFrame: From treatment up to 12 months post treatment
measure: International consultation on incontinence questionnaire-urinary incontinence
timeFrame: From treatment up to 12 months post treatment
measure: Pelvic organ prolapse/urinary incontinence sexual questionnaire
timeFrame: From treatment up to 12 months post treatment
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam health care campus
Study officials:
affiliation: Rambam healthcare campus
name: Roy Lauterbach, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01883856: Comparison of Silicone and Porous Plate Ahmed Glaucoma Valves
Official title: Comparison of Silicone and Porous Plate Ahmed Glaucoma Valves
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Keywords: Refractory Glaucoma
Intractable Glaucoma
Primary Open Angle Glaucoma
Neovascular Glaucoma
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: New World Medical, Inc.
First posted: 2013-06-21
Enrollment: 52
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: The purpose of this study is to evaluate and compare the clinical outcomes after implantation of the porous plate (polyethylene) (Model M4) Ahmed Glaucoma Valve with the silicone plate Ahmed Glaucoma Valve (Model FP7) in participants with refractory glaucoma.

Detailed description: The purpose of this study is to evaluate and compare the clinical outcomes after implantation of the porous plate (polyethylene) (Model M4) Ahmed Glaucoma Valve with the silicone plate Ahmed Glaucoma Valve (Model FP7) in participants with refractory glaucoma. Participation will last for 12 months.

Eligibility criteria: Inclusion Criteria:

* Male or female of any race ≥ 18 years and ≤ 80 years of age.
* Diagnosis of intractable glaucoma in the study eye, with the exception of silicone oil endotamponade induced glaucoma, which has not responded to conventional medical and surgical therapy.
* Elevated intraocular pressure \> 21 mmHg in the study eye. Two consecutive measurements using Goldmann Applanation Tonometry will be obtained and the mean of those two measurements will be considered the subject's baseline intraocular pressure.
* Subject is a candidate for surgery in the study eye with a glaucoma drainage device.
* Subject is willing and able to sign the informed consent.

Exclusion Criteria:

* Diagnosis of silicone oil endotamponade induced glaucoma in the study eye.
* History of prior drainage implant surgery in the study eye.
* History of cyclophotocoagulation of the study eye.
* Pregnancy.
* Prisoner.

Primary outcomes:
measure: Change in Intraocular Pressure
timeFrame: 12 months
Secondary outcomes:
measure: Anti-Glaucoma Medications
timeFrame: 12 months
measure: Surgical Success
timeFrame: 12 months
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Peter A Netland, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roa TM, Netland PA, Costa VP, Sarkisian SR Jr, Al-Aswad LA, Moster MR, Ahmed IIK. Comparison of Silicone- and Porous-Plate Ahmed Glaucoma Valves. Med Devices (Auckl). 2020 Jul 16;13:213-221. doi: 10.2147/MDER.S258498. eCollection 2020.
Clinical trial NCT06946056: Evaluation of the Effect of Biofiller PRP Application on Knee Osteoarthritis
Official title: Evaluation of the Effect of Biofiller PRP Application on Range of Motion, Pain, Quality of Life and Femoral Cartilage Thickness in Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Biofiller PRP
Femoral Cartilage Thickness
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2025-04-27
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the effects of biofiller PRP, on pain, range of motion, quality of life, and femoral cartilage thickness in patients with knee osteoarthritis.

Detailed description: Patients who are admitted and diagnosed with knee osteoarthritis based on anamnesis, physical examination and imaging methods are included in the study

Eligibility criteria: Inclusion Criteria:

1-45-65 years old 2-Diagnosis of knee OA according to ACR clinical and radiological diagnostic criteria 3-Kellgren Lawrence stage II or III 4-Knee pain for at least 6 months 5-Visual analog scale (VAS) score of at least 3 or more

Exclusion Criteria:

1 - History of surgery or traumatic injury 2-Inflammatory arthritis 3-History of cancer, bleeding diathesis and psychiatric disease 4-Those who have a disease that limits their participation in exercises (severe chronic obstructive lung disease, severe heart failure, history of cerebrovascular events) 5-Hip and ankle problems 6-Participating in another physical therapy program in the last 3 months 7-History of intra-articular injections in the last 6 months

Primary outcomes:
measure: Visual Analog Scale (VAS) Change from baseline in pain on the VAS at month 3
timeFrame: Baseline and month 3
Secondary outcomes:
measure: Western OntarioMacMaster (WOMAC) Change from baseline in pain and physical functions on Western OntarioMacMaster scale at month
timeFrame: Baseline and month 3
measure: Femoral cartilage thickness Change from baseline in knee joint on the measuring the femoral cartilage thickness at month 3
timeFrame: Baseline and month 3
Other outcomes:
Locations:
Study officials:
affiliation: Necmettin Erbakan University, Konya, Turkey
name: BANU ORDAHAN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02709356: Medium Chain Triglycerides and Brain Metabolism in Alzheimer's Disease
Official title: Proof of Concepts: Can a Supplement Ketogenic Based MCT Oil Increases Cerebral Capture Ketones in People With Alzheimer's Disease?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer's Disease
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Fondation Vitae
First posted: 2016-03-16
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate and compare the changes in brain ketone and glucose uptake after taking two different MCT oil emulsions (60-40 oil or C8 oil) for one month, in a group of people with Alzheimer's disease and a control group.

Detailed description: Based on a PET/MRI protocol, the aim of this study is to evaluate and compare the response to the dietary supplementation of two different MCT oils (60% C10 + 40% C8 or 100 % C8) in two groups, patients with Alzheimer's disease and healthy elderly people (N=10/group). After a baseline evaluation, participant will test one of the supplements during two successive periods of one month; each period of time ending with 18F-FDG and 11C-acetoacetate PET scans.

Eligibility criteria: Inclusion Criteria:

* Good general health for Control group
* Diagnosis of Alzheimer's disease (NINCDS-ADRDA criteria) for AD group

Exclusion Criteria:

* Depression
* Medical or psychiatric conditions that could interfere with study participation
* Fasting plasma glucose ≥7.0 mM (diabetes or prediabetes)
* Already on MCT supplementation
* Clinically-significant gastrointestinal disease/conditions
* Clinically-significant liver disease/dysfunction
* Clinically-significant renal disease/dysfunction
* Clinically-significant cardiac disease/conditions
* Hypertension
* Uncontrolled dyslipidaemia
* Vitamin B12 deficiency
* Structured physical activity (more than 3 times/week)

Primary outcomes:
measure: Quantification of brain glucose uptake
timeFrame: 1-month
measure: Quantification of brain acetoacetate uptake
timeFrame: 1-month
Secondary outcomes:
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS)
state: Quebec
Study officials:
affiliation: Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS) - Université de Sherbrooke
name: Stephen Cunnane, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01855256: Treatment of Hyperhidrosis With Oxybutynin
Official title: Treatment of Hyperhidrosis With Oxybutynin: a Randomized Controlled Double Blind Against Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperhidrosis
Keywords: hyperhidrosis
oxybutynin
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2013-05-16
Enrollment: 62
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: Evaluation of the effectiveness of oxybutynin in hyperhidrosis


Eligibility criteria: Inclusion Criteria:

* Age greater than 18 years
* Patient affiliated to social security or beneficiary of such a regime
* Patient able to consent
* Patient with hyperhidrosis, generalized or localized (palmar, plantar, axillary) and whose score HDSS (Hyperidrosis Disease Severity Scale) is greater than two.

Exclusion Criteria:

* Age less than 18 years
* Patient who can't be followed
* Patient participating in another clinical trial
* Pregnant
* Woman breastfeeding
* Hypersensitivity to oxybutynin or any of the excipients
* Risk of urinary retention related disorders uretroprostatiques
* Intestinal obstruction
* Toxic megacolon
* Intestinal atony
* Severe Ulcerative Colitis
* Myasthenia
* Closure glaucoma the anterior chamber angle or slightly deep

Primary outcomes:
measure: Evaluation of the effectiveness of oxybutynin in hyperhidrosis
timeFrame: 6 weeks
Secondary outcomes:
measure: Safety evaluation of treatment in this indication
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Brest
country: France
facility: Hospital, Brest
city: Landerneau
country: France
facility: CHG Landerneau
city: Morlaix
country: France
facility: CHG de Morlaix
city: Quimper
country: France
facility: Dermatologist'S Office
Study officials:
affiliation: ADBO
name: Martine SCHOLLHAMMER, MD
role: PRINCIPAL_INVESTIGATOR
References: