louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06590688: Defining Volume Status with Extracellular Water Measurement in Patients with Intracranial Hemorrhage
Official title: Extracellular Water for Volume Status Characterization in Patients with Intracranial Hemorrhage
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Intracranial Hemorrhages
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients admitted to ICU in Uppsala with intracranial hemorrhage.

Brief summary: The goal of this observational study is to learn about the influence of extracellular water on volume status in adult patients with intracranial hemorrhage presenting with hemodynamic instability. The main question it aims to answer is:

• Can measurement of extracellular water contribute to the description of hemodynamic instability in adult patients with intracranial hemorrhage. Patients with intracranial hemorrhage admitted to intensive care will receive standard care with the addition of measurement of extracellular water.

Detailed description: Adult patients with intracranial hemorrhage admitted to ICU will be recruited. During the first five days after inclusion blood samples and extended non-invasive monitoring, including monitoring of the microcirculation (CytoCam) and measurement of extracellular water (dielectronic constant), will be added to routine care and monitoring.

Eligibility criteria: Inclusion Criteria:

* Adults with intracranial hemorrhage admitted to ICU.

Exclusion Criteria:

* Pregnancy, palliative care.

Primary outcomes:
measure: Extracellular water for volume status characterization in patients with intracranial hemorrhage.
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Uppsala University, Region Uppsala
name: Annelie Barrueta Tenhunen
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nuutinen J, Ikaheimo R, Lahtinen T. Validation of a new dielectric device to assess changes of tissue water in skin and subcutaneous fat. Physiol Meas. 2004 Apr;25(2):447-54. doi: 10.1088/0967-3334/25/2/004.
citation: Toro C, Markarian B, Mayrovitz HN. Breast Cancer-Related Lymphedema Assessed via Tissue Dielectric Constant Measurements. Cureus. 2024 Apr 29;16(4):e59261. doi: 10.7759/cureus.59261. eCollection 2024 Apr.
citation: Gress DR; Participants in the International Multi-Disciplinary Consensus Conference on the Critical Care Management of Subarachnoid Hemorrhage. Monitoring of volume status after subarachnoid hemorrhage. Neurocrit Care. 2011 Sep;15(2):270-4. doi: 10.1007/s12028-011-9604-x.
Clinical trial NCT01950988: Effectiveness of a Novel Concept for a Manual Toothbrush Broscyl®
Official title: Effectiveness and Satisfaction-adaptability of a Novel Concept for a Manual Toothbrush Broscyl®: Randomised Clinical Trial in Children, Adults and Elderly People
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Healthy Subjects
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2013-09-26
Enrollment: 142
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The aim is to determine the efficacy and the satisfaction/adaptability of the manual Broscyl® toothbrush as compared with a standard " soft " manual toothbrush ADA (American Dental Association) reference using the modified Stillman brushing technique, in children, adults and elderly persons, after 3 months of daily use.


Eligibility criteria: Inclusion Criteria:

* Children attending school aged between 8 and 15 years
* OR adults aged from 18 to 45 years
* OR elderly persons aged more than 65 years old
* Presenting at least one incisive, one canine, one premolar and one molar in each quadrant
* Able to brush their own teeth at least twice a day
* Persons who have provided written informed consent
* Persons covered by the national health insurance agency

Exclusion Criteria:

* Persons with acute periodontal disease
* Persons in a period of postsurgical healing
* Persons with an acute oral pain syndrome
* Persons undergoing orthodontic treatment with a fixed brace
* Persons not covered by the national health insurance agency
* Pregnant women
* The use of adjuvants

Primary outcomes:
measure: Measurement of the dental plaque index
timeFrame: up to 3 months
Secondary outcomes:
measure: Patient satisfaction
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon
Study officials:
References:
Clinical trial NCT01940588: Neuropsychoanalytic Treatment of Failed Back Surgery Syndrome-Opioid Dependence
Official title: Neuropsychoanalytic Treatment of Failed Back Surgery Syndrome-Opioid Dependence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Lead sponsor: State University of New York - Upstate Medical University
Sponsor class: OTHER
Collaborators: name: University at Buffalo
First posted: 2013-09-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with failed back surgery syndrome and opioid use disorder 18 years of age and older

Brief summary: Opioid Dependent Patients who have failed back surgery syndrome are detoxified and treated with a neuropsychoanalytic paradigm.

Detailed description: Patients were detoxified from opioid analgesics and treated with NSAIDs and other non-opioid analgesics, received neuropsychoanalytic therapy and low dose naltrexone. Patients kept a daily diary of: 0 - 10 pain, 0 - 10 function, hours worked, amount of alcohol drunk, illicit and licit drug use, number of health care provider appointments attended, number of self-help groups meetings attended across each of the six months of study. Six month outcomes of this approach with primary outcomes being sobriety, pain scores and function scores.

Eligibility criteria: Inclusion Criteria:

1. Have failed back surgery syndrome.
2. Have evidence of Opioid Dependence by meeting DSM-IV criteria and by Drug Abuse Screening Test \> 4. (In case of a difference in these two measures, clinical staff will talk with the patient to adjudicate the difference.)
3. Over 18
4. Be able to understand spoken and written English
5. Reside within 30 miles of the site of treatment for ease of followup
6. Have health insurance or other ability to pay for treatment

Exclusion Criteria:

1. Homeless
2. Unable to give consent (e.g. neurological disorders, dementia, psychosis)
3. Co-occurring incapacitating psychiatric disorder such as schizophrenia
4. Pregnant
5. Financial incentive to stay ill, such as a pending disability claim
6. Member of a vulnerable population, including prisoners

Primary outcomes:
measure: Improvement of pain
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: State University of New York - Upstate Medical University
name: Brian Johnson, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00749788: Efficacy and Safety Study of JTT-302 in Subjects With Low HDL-C Levels
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group Study Evaluating the Efficacy and Safety of JTT-302 Administered Daily for Four Weeks in Subjects With Low HDL-C Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dyslipidemia
Lead sponsor: Akros Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2008-09-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 determine the effect of JTT-302 on the increase of High Density Lipoprotein-Cholesterol (HDL-C) levels when administered daily for four weeks in subjects with low HDL-C levels.


Eligibility criteria: Inclusion Criteria:

* Subjects with a Body Mass Index (BMI)≤ 35 kg/m2
* Subjects with the following lipid parameters at Visit 1 (screening visit) and Visit 3 (diet stabilization period):
* HDL-C ≤ 40 mg/dL (Men) and ≤ 50 mg/dL (Women)
* TG ≤ 500 mg/dL
* LDL-C ≤ 190 mg/dL
* Subjects who are generally healthy as determined by pre-study medical history, physical examination, vital signs and 12-lead ECG

Exclusion Criteria:

* Females who are pregnant or breast-feeding
* AST, ALT or total bilirubin ≥ 2.0 x ULN at Visit 1 (screening visit) or Visit 3 (diet stabilization period)
* Serum thyroid stimulating hormone (TSH) and levothyroxine (T4) outside of the central laboratory reference range at the screening visit
* Medical history of diabetes mellitus or two fasting serum glucose measurements \> 126 mg/dL at the screening visit
* Subjects with hypertension, or two blood pressure measurements ≥ 140 mm Hg systolic or ≥ 90 mm Hg diastolic at the screening visit
* History of drug or alcohol abuse within 12 months of the screening visit
* Use of medications defined in the protocol within six-weeks prior to the screening visit and throughout the study
* Use of Cytochrome P450 3A4 inducers or inhibitors, as defined in the protocol within four weeks of the screening visit and throughout the study

Primary outcomes:
measure: Percent change from baseline in HDL-C at Week 4
timeFrame: 4 weeks
Secondary outcomes:
measure: Percent change and change from baseline at week 4 in lipid parameters
timeFrame: 4 weeks
measure: Evaluate the safety profile of JTT-302 when administered for 4 weeks
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Santa Ana
country: United States
state: California
Study officials:
References:
Clinical trial NCT00422188: Deoxycholic Acid Injection for the Treatment of Superficial Lipomas
Official title: Phase 1, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Dose-Escalation Study of the Pharmacokinetics, Safety, and Efficacy of ATX-101 (Sodium Deoxycholate for Injection) Intralipomal Injections for the Treatment of Superficial Lipomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lipoma
Lead sponsor: Kythera Biopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-01-15
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to compare the safety and effectiveness of 4 different concentrations of deoxycholic acid injection against a placebo in the treatment of superficial lipomas.

Detailed description: A lipoma is a fatty lump typically located on the trunk, shoulder, arms or legs. For the purposes of this study, only lipomas on the trunk, arms, legs, or neck were treated. (Lipomas on the face, wrists, hands, lower portion of the spine, genitals, ankles, or feet were not treated.)

Eligibility criteria: Inclusion Criteria:

* One or more lipomas, based on clinical diagnosis, which are accessible for treatment and assessment, are quantifiable along at least 2 perpendicular diameters, and have the following characteristics:

  * History of slow growth followed by dormancy, and stable for at least 6 months.
  * Greatest length by greatest perpendicular width between 1 and 16 square centimeters, inclusive
  * Discrete, oval to rounded in shape, not hard or attached to underlying tissue
  * Located on the trunk, arms, legs, or neck
* Stable body weight with a body mass index of less than 30 kg/m²
* Signed informed consent

Exclusion Criteria:

* Absence of significant medical conditions that could affect safety
* History of surgical treatment for lipomas
* Treatment with an investigational agent within 30 days before ATX-101 treatment

Primary outcomes:
measure: Assessments of Safety with Laboratory tests
timeFrame: up to 16 weeks
measure: Assessments of Safety with ECG
timeFrame: up to 16 weeks
measure: Assessments of Safety with Medical Evaluations
timeFrame: up to 16 weeks
Secondary outcomes:
measure: Lipoma size reduction
timeFrame: up to 16 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
Study officials:
affiliation: Therapeutics Clinical Research
name: Stacy R. Smith, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00479388: Study of Extended Release Niacin/Laropiprant on Lipids (0524A-067)
Official title: A Multicenter, Randomized, Double-Blind, Parallel Group, 12 Week Study to Evaluate the Efficacy and Safety of Extended-release (ER) Niacin/Laropiprant in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Hypercholesterolemia
Mixed Dyslipidemia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-05-28
Enrollment: 1216
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: This is a 12-Week clinical trial in patients with Primary hypercholesterolemia or mixed dyslipidemia to study the effects of ER niacin/laropiprant on lipids.


Eligibility criteria: Inclusion Criteria:

* Patients 18 to 80 years of age with Primary hypercholesterolemia or mixed dyslipidemia
* Patients will be eligible for the study if their LDL-C values are within protocol specified range and meet other entry criteria

Exclusion Criteria:

* Patient whose LDL-C values are not within protocol specified range

Primary outcomes:
measure: Percent Change From Baseline in Low Density Lipoprotein Cholesterol at Week 12
timeFrame: Baseline and 12 Weeks
Secondary outcomes:
measure: Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 12
timeFrame: Baseline and 12 Weeks
measure: Percent Change From Baseline in Triglycerides at Week 12
timeFrame: Baseline and 12 Weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Shah S, Ceska R, Gil-Extremera B, Paolini JF, Giezek H, Vandormael K, Mao A, McCrary Sisk C, Maccubbin D. Efficacy and safety of extended-release niacin/laropiprant plus statin vs. doubling the dose of statin in patients with primary hypercholesterolaemia or mixed dyslipidaemia. Int J Clin Pract. 2010 May;64(6):727-38. doi: 10.1111/j.1742-1241.2010.02370.x.
citation: Bays HE, Shah A, Lin J, Sisk CM, Dong Q, Maccubbin D. Consistency of extended-release niacin/laropiprant effects on Lp(a), ApoB, non-HDL-C, Apo A1, and ApoB/ApoA1 ratio across patient subgroups. Am J Cardiovasc Drugs. 2012 Jun 1;12(3):197-206. doi: 10.2165/11631530-000000000-00000.
citation: Bays H, Shah A, Dong Q, McCrary Sisk C, Maccubbin D. Extended-release niacin/laropiprant lipid-altering consistency across patient subgroups. Int J Clin Pract. 2011 Apr;65(4):436-45. doi: 10.1111/j.1742-1241.2010.02620.x.
Clinical trial NCT01168388: Movement Disorder Survey in East China
Official title: Movement Disorder Survey in East China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Dystonia
Hemifacial Spasm
Keywords: Dystonia
Hemifacial spasm
Cervical dystonia
Blepharospasm
Lead sponsor: Sir Run Run Shaw Hospital
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2010-07-23
Enrollment: 1600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients seeking treatment in movement disorder clinics in east China during April 2010 to August 2010.

Brief summary: Movement disorder involve recurring or constant muscle contractions causing squeezing or twisting movement, such as hemifacial spasm, blepharospasm, cervical dystonias etc. The most common focal dystonia was cervical dystonia in western countries according to previous studies, which is different from China in Chinese neurologists' opinion. And there is no such survey. So the investigators are conducting a movement disorder survey in east China to confirm it.


Eligibility criteria: Inclusion Criteria:

* Patients seeking treatment in movement disorder clinics(include naive or may have previously been to clinics)

Exclusion Criteria:

* Patients who have received this movement disorder survey

Primary outcomes:
measure: Number of participants with primary dystonia
timeFrame: half year
Secondary outcomes:
measure: Number of participants with hemifacial spasm
timeFrame: half year
measure: Number of participants with blepharospasm
timeFrame: half year
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital
state: Zhejiang
Study officials:
affiliation: Sir Run Run Shaw Hospital
name: Xingyue Hu, MD
role: STUDY_CHAIR
References:
citation: Castelon Konkiewitz E, Trender-Gerhard I, Kamm C, Warner T, Ben-Shlomo Y, Gasser T, Conrad B, Ceballos-Baumann AO. Service-based survey of dystonia in munich. Neuroepidemiology. 2002 Jul-Aug;21(4):202-6. doi: 10.1159/000059525.
citation: Matsumoto S, Nishimura M, Shibasaki H, Kaji R. Epidemiology of primary dystonias in Japan: comparison with Western countries. Mov Disord. 2003 Oct;18(10):1196-8. doi: 10.1002/mds.10480.
citation: Butler AG, Duffey PO, Hawthorne MR, Barnes MP. An epidemiologic survey of dystonia within the entire population of northeast England over the past nine years. Adv Neurol. 2004;94:95-9. No abstract available.
citation: Muller J, Kiechl S, Wenning GK, Seppi K, Willeit J, Gasperi A, Wissel J, Gasser T, Poewe W. The prevalence of primary dystonia in the general community. Neurology. 2002 Sep 24;59(6):941-3. doi: 10.1212/01.wnl.0000026474.12594.0d.
citation: Nutt JG, Muenter MD, Aronson A, Kurland LT, Melton LJ 3rd. Epidemiology of focal and generalized dystonia in Rochester, Minnesota. Mov Disord. 1988;3(3):188-94. doi: 10.1002/mds.870030302.
Clinical trial NCT01824888: Efficacy of JUC as Hand Rub Evaluated by Using European Standard 1500
Official title: The Effectiveness and Efficacy of Using JUC Antimicrobial Spray for Controlling the Infection Transmission
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infectious Disease Transmission
Keywords: JUC
hand rub
European standard
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2013-04-05
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: JUC is a commercially available wound care spray. It is evaluated for the efficacy when using as a hygienic hand rub following the protocol described in the European standard EN 1500:1997 "Chemical disinfectants and antiseptics - Hygienic handrub - Test method and requirement (phase 2/step 2)". A crossover study to compare the JUC solution with 60% (v/v) propan-2-ol by using Escherichia coli K12 NCTC strain 10538 as test organism.

Detailed description: Before the intervention, the bactericidal activity of JUC was validated in accordance with the prEN 12054. A total of 15 volunteers were recruited, hands were washed immediately prior to the intervention. Then, both hands of each volunteer were immersed into a contamination fluid of E. coli. Then, hand rub was performed with JUC or alcohol. Culture samples were collected before and after the hand rub by rubbing the fingertips and thumb tips of each hand ont he base of a Petri dish containing appropriate medium. The culture inoculation, incubation, appropriate dilutions, and colony count were performed.

Eligibility criteria: Inclusion Criteria:

* healthy and absence of significant illness

Exclusion Criteria:

* Visible wounds on hands

Primary outcomes:
measure: Change of Colony forming units on hands from pre-value (baseline) to post-value
timeFrame: Pre-value (baseline) as 0 minutes: at the time after handwashing and before application of JUC or alcohol; Post-value at 5 minutes after the baseline: as after hand contamination, application of JUC or alcohol and drying of hands
Secondary outcomes:
measure: Change of colony forming units on hands from baseline to 8 hours after hand rubbing with JUC
timeFrame: Pre-value (baseline) at 0 hour: at the first time after applicaiton of JUC and challenged by the bacteria; Post-values measured at each hour (1,2,3,4,5,6,7 and 8 hours) after the initial application of JUC and bacterial challenge at every hour
Other outcomes:
measure: Bactericidal efficacy of JUC and neutralizer
timeFrame: 1 day
Locations:
city: Kowloon
country: Hong Kong
facility: PolyU Biomedical Science Laboratory
Study officials:
affiliation: The Hong Kong Polytechnic University
name: John Yuen, PhD
role: PRINCIPAL_INVESTIGATOR
References: