louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01289613: Clinically Relevant Asymmetry of Bispectral Index
Official title: Clinically Relevant Asymmetry of Bispectral Index During Anesthesia for ENT Surgery in Adults and Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Reaction; Anesthesia
Keywords: Bispectral Index
Anesthesia
Asymmetry
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2011-02-04
Enrollment: 88
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and adults during anesthesia for ENT surgery

Brief summary: BIS for monitoring depth of anesthesia is usually obtained unilaterally. Obtaining BIS bilaterally revealed side differences in previous studies. This study investigates the incidence of clinically relevant side differences of BIS during maintenance and emergence from anesthesia for ENT surgery in both adults and children.

Detailed description: BIS was measured bilaterally in 42 adults and 46 children during ENT surgery under general anesthesia using two BIS-Monitors. Side differences of more than 10% were defined as BIS asymmetries. An increase of BIS of more than 10% from the value at the time of finishing anesthesia administration on only one side followed by movement after stimulation was defined as clinically relevant.

Eligibility criteria: Inclusion Criteria:Children and adults during anesthesia for ENT surgery -

Exclusion Criteria:Neurologic or psychiatric disease

-

Primary outcomes:
measure: Movement reaction to external stimulation during emergence from anesthesia
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: University Hospital Schleswig-Holstein, Campus Kiel
Study officials:
affiliation: University Clinic Schleswig-Holstein, Campus Kiel
name: Axel Fudickar, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05691413: Safety and Efficacy of Facial Cleanser
Official title: The Safety and Efficacy of Facial Cleanser Containing Combination of Olive Oil, Virgin Coconut Oil, Butylene Glycol and Hyaluronic Acid on Skin Hydration and Skin Elasticity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Aesthetic
Cosmetic
Lead sponsor: Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre
Sponsor class: INDUSTRY
First posted: 2023-01-20
Enrollment: 30
Sex: ALL
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study is conducted to evaluate the safety and effectiveness of facial cleanser X containing combination of olive oil, virgin coconut oil, butylene glycol and hyaluronic acid on skin hydration and skin elasticity. The study duration is 5 weeks and the skin assessment will be carried out at baseline, week 3 and week 5.The main questions this study aims to answer are:

1. The effect of product on skin hydration.
2. The effect of product on skin elasticity.
3. To observe any adverse effect occurrence with the usage of the product.


Eligibility criteria: Inclusion Criteria:

* Malaysia citizen
* Male and female (age 35-55 years old)

Exclusion Criteria:

* Participants who have acne which require medical treatment.
* Participants taking isotretinoin
* Participants who had undergo any cosmetic procedures such as laser \& light treatment, botulinum toxin A injections and chemical peeling for the past 3 months
* Participants who are immunocompromised
* Participants with history of facial surgery

Primary outcomes:
measure: Change in skin hydration from baseline and at week 3 and 5 after using facial cleanser X
timeFrame: Baseline, week 3 and week 5
measure: Change in skin elasticity from baseline and at week 3 and 5 after using facial cleanser X
timeFrame: Baseline, week 3 and week 5
measure: Adverse effect after using facial cleanser X
timeFrame: Week 5
Secondary outcomes:
Other outcomes:
Locations:
city: Petaling Jaya
country: Malaysia
facility: Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre
state: Selangor
Study officials:
References:
Clinical trial NCT04061213: ATTR Amyloidosis in Elderly Patients With Aortic Stenosis
Official title: ATTR Amyloidosis in Elderly Patients With Aortic Stenosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Stenosis Symptomatic
Amyloidosis Cardiac
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2019-08-19
Enrollment: 489
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with symptomatic, severe aortic stenosis undergoing pre-evaluation for (transcatheter) aortic valve replacement

Brief summary: Severe aortic stenosis is defined with a mean transvalvular pressure gradient (MTPG) \> 40mmHg and a calculated aortic valve area of \< 1cm2. However, a considerable proportion of patients do have a MTPG \< 40mmHg due to a reduced stroke volume (stroke volume indexed to body surface area ≤ 35ml/m2) despite a normal left ventricular ejection fraction (LVEF \> 50%). This entity is termed paradoxical low flow low gradient aortic stenosis (PLFLG AS) and is associated with a worse prognosis.

ATTR amyloidosis is a disease of the elderly and might coexist in patients with severe aortic stenosis. Case reports and small observational studies suggest that senile ATTR amyloidosis could be frequent but underdiagnosed in patients with aortic stenosis. There is significant overlap between PLFLG AS and cardiac amyloidosis with regard to symptoms, increasing prevalence with age, concentric hypertrophy, impaired diastolic filling of the left ventricle (LV), as well as longitudinal LV dysfunction despite preserved ejection fraction - all features, which lead to a reduction in stroke volume, the underlying mechanism of the low flow condition as observed in PLFLG AS patients.


Eligibility criteria: Inclusion Criteria:

* Symptomatic, severe aortic stenosis

Exclusion Criteria:

* More than mild valvular disease of any other valve
* Other severe disease with a life expectancy \< 1 year
* Participating in trial interfering with routine clinical practice or use of a non-CE marked device

Primary outcomes:
measure: Proportion of patients with grade 2 or 3 cardiac uptake in scintigraphy and without pathological light chains in immunological assays
timeFrame: In-Hospital [7 days]
Secondary outcomes:
measure: All-cause and cardiovascular mortality
timeFrame: 30 days, 12months
measure: CPET - maximal exercise capacity
timeFrame: In-Hospital [7 days]
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University Hospital Bern - Inselspital
state: BE
Study officials:
affiliation: Swiss Cardiovascular Center Bern
name: Stefan Stortecky, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02434913: HUD: PIP Joint Implant
Official title: HUD: Proximal Interphalangeal (PIP) Joint Implant Finger Prosthesis
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Arthrosis
Osteoarthrosis
Keywords: Proximal interphalangeal joint deformity
Arthroplasty
Lead sponsor: The Hawkins Foundation
Sponsor class: OTHER
First posted: 2015-05-06
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT

Brief summary: This surgery involves the use of a finger joint replacement device for treatment of patients with certain kinds of arthritis (osteo - arthritis or post traumatic arthritis) and who expect to place their hands in heavy loading situations, or patients needing revision of a failed implant placed in the PIP joint. A joint replacement surgery is an operation where the arthritic joint is removed and a metal and plastic joint is inserted to replace the natural joint. The surgery is expected to last about 2 hours. The procedure is done in the operating room and requires general anesthesia or an axillary block. (General anesthesia affects the entire body and is accompanied by a loss of consciousness. An axillary block results in anesthesia of the hand and forearm only. A tourniquet is applied to the arm to prevent bleeding during the surgery.)


Eligibility criteria: Inclusion Criteria:

* Patients with disability of the their finger from arthrosis

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Steadman Hawkins Clinic of the Carolinas - Greenville Health System
name: Timothy Allen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00986713: Value of Amphotericin B Inhalation for Prophylaxis of Invasive Pulmonary Aspergillosis After Renal Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Invasive Pulmonary Aspergillosis
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2009-09-30
Enrollment: 400
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: PREVENTION

Brief summary: The purpose of this study is to determine whether inhalation with aerosolized amphoterin B 10mg/d is more effective than aerosolized amphoterin B 2mg/d to reduce the incidence of invasive pulmonary aspergillosis.


Eligibility criteria: Inclusion Criteria:

* 65ys≥age≥18ys
* renal transplant recipients

Exclusion Criteria:

* subjects with hypersensitivity to amphotericin B
* receipt of inhalational or intravenous amphotericin B within last 30 days
* subjects with known invasive fungal infection before renal transplant
* subjects with pneumonia

Primary outcomes:
measure: invasive pulmonary aspergillosis
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chaoyang Hospital,Affiliate of Capital Medical University
state: Beijing
Study officials:
References:
Clinical trial NCT00404313: The Effect of MK0633 in Patients With Chronic Asthma (0633-007)
Official title: A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Parallel-Group, Dose-Ranging Study of MK0633 in Adult Patients With Chronic Asthma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Asthma
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-11-28
Enrollment: 688
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A clinical study to evaluate the efficacy and safety of MK0633 in adult patients with chronic asthma.


Eligibility criteria: Inclusion Criteria:

* Documented clinical history of symptoms of chronic asthma, including dyspnea, wheezing, chest tightness, cough, and/or sputum production
* Males and females 18-70 years of age

Exclusion Criteria:

* History of kidney or chronic liver disease
* Recent history of heart problems within the past 3 months
* Evidence of another clinically significant, active lung disorder such as bronchiectasis or COPD

Primary outcomes:
measure: Pulmonary function test data measured over 6 weeks
timeFrame: 6 weeks
Secondary outcomes:
measure: Overall daytime and nighttime symptoms score, beta-agonist use, asthma exacerbations, asthma-specific quality of life questionnaire score, measured over 6 weeks
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Wasfi YS, Villaran C, de Tilleghem Cle B, Smugar SS, Hanley WD, Reiss TF, Knorr BA. The efficacy and tolerability of MK-0633, a 5-lipoxygenase inhibitor, in chronic asthma. Respir Med. 2012 Jan;106(1):34-46. doi: 10.1016/j.rmed.2011.08.019. Epub 2011 Sep 25.
Clinical trial NCT01786213: Training Effects in Colonoscopy
Official title: The Impact of Training Effects on Quality Indicators in Colonoscopy: a Retrospective Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adenoma Detection Rate
Keywords: adenoma detection rate, colonoscopy, trainee, learning curve
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2013-02-07
Enrollment: 3500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Endoscopy Department of a university Hospital

Brief summary: Colon cancer is the second most common cause of death among cancer-related deaths in Germany. Precancerous lesions such as adenomas can be detected efficiently by colonoscopy. To provide high quality in colonoscopy several quality parameters have been postulated in the past. The adenoma detection rate (ADR) is one of those parameters. Empirical data suggest that a detection rate of 20% should be demanded. Detection rates are influenced by a multitude of circumstances such as bowel cleanness. The facts that detection rates vary between colonoscopists suggests that leaning effects may also play a role. It is not known how ADR and other quality parameters evolve while trainees improve their skills in colonoscopy. The investigators postulate that a learning curve exists. The investigators therefore plan to evaluate chronologically the findings of trainee colonoscopists. A particular performance in detecting adenomas shall be calculated in relation to the amount of examinations performed.


Eligibility criteria: Inclusion Criteria:

* colonoscopy performed at the Technical University Munich, Germany

Exclusion Criteria:

* colonoscopy performed for the purpose of polypectomy

Primary outcomes:
measure: Adenoma detection rate
timeFrame: every 50 examinations
Secondary outcomes:
measure: Polyp detection rate
timeFrame: every 50 examinations
Other outcomes:
measure: Amount of sedative used
timeFrame: every 50 exmainations
Locations:
city: Munich
country: Germany
facility: Medizinische Klinik und Poliklinik der Technischen Universität München
state: Bayern
Study officials:
References:
Clinical trial NCT03478618: Comparison of Different Protocols of Fluid Therapy in Severe Preeclamptic Patients Under Spinal Anesthesia
Official title: Comparison of Two Different Protocols of Fluid Therapy in Severe Preeclamptic Patients Under Spinal Anesthesia : Hemodynamic and Kidney Function Outcome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Hypotension Drug-Induced
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-03-27
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To compare the effect of two different protocol of fluid therapy in sever preeclamptic patients under spinal anesthesia : Hemodynamic and kidney function .


Eligibility criteria: Inclusion Criteria:

* more than 36 weeks gestation
* singleton pregnant women planned for elective caesarian section

Exclusion Criteria:

* patient refusal.
* psychiatric disorders.
* parturient \<36 weeks gestation, twins, abnormal cardiotocography (CTG) tracing.
* absolute contraindications for spinal anesthesia (patients refusal, raised intracranial pressure, hypovolemic states, abnormal coagulopathy).

Primary outcomes:
measure: incidence of hypotension
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Ansari MR, Laghari MS, Solangi KB. Acute renal failure in pregnancy: one year observational study at Liaquat University Hospital, Hyderabad. J Pak Med Assoc. 2008 Feb;58(2):61-4.
citation: Ganesan C, Maynard SE. Acute kidney injury in pregnancy: the thrombotic microangiopathies. J Nephrol. 2011 Sep-Oct;24(5):554-63. doi: 10.5301/JN.2011.6250.
Clinical trial NCT01004718: Detection and Quant of Differences in Hodgkin Lymphoma and Diffuse Large B-cell Lymphoma Using Positron Emission Tomography/Computed Tomography (PET/CT)
Official title: A Pilot Study to Assess the Feasibility of Detection and Quantification of Differences in Hodgkin Lymphoma and Diffuse Large B-cell Lymphoma Using FDG-PET/CT Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphoma
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2009-10-30
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: RATIONALE: Imaging procedures, such as positron emission tomography or computed tomography, may help in detecting differences between Hodgkin lymphoma or diffuse large B-cell lymphoma cancer cells. PURPOSE: This clinical trial is studying positron emission tomogaphy and computed tomography in determining differences in Hodgkin lymphoma and diffuse large B-cell lymphoma.

Detailed description: OBJECTIVES:

I. Assess the feasibility of detection and quantification of differences in the temporal and spatial distribution of FDG uptake between lesions of HL and DLBCL.

OUTLINE:

Patients undergo fludeoxyglucose F18 (FDG) positron emission tomography/computed tomography scans 60 and 180 minutes after FDG administration.

After completion of study, patients are followed for 24 hours.

Eligibility criteria: Inclusion Criteria:

* Subjects with a pathologically-proven diagnosis of classic HL or DLBCL with measurable disease by any imaging technique or physical examination.

Exclusion Criteria:

* Pregnant or nursing,
* Uncontrolled diabetes mellitus,
* Active infection,
* Inability to give informed consent or to comply with all study procedures,
* Subjects may be excluded at the discretion of the principal investigator or study team members.

Primary outcomes:
measure: Percentage Change in Maximum Lesional FDG Uptake From 60 to 180 Minutes After FDG Administration
timeFrame: 2 hours (between 60 minutes post-administration and 180 minutes post-administration)
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00505518: Investigating the Effectiveness of Telepsychiatry for Treating Major Depression in a Chinese American Nursing Home
Official title: Feasibility and Effectiveness of Telepsychiatry for Collaborative Management of Chinese Americans With Psychiatric Disorders in a Nursing Home
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder
Telepsychiatry
Chinese American
Nursing Home
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2007-07-23
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The current use of telepsychiatry, or psychiatric care using videoconferencing, is very limited. The present study investigates the use of this method with a depressed Chinese American population in a nursing home. It is believed that this population can benefit from telepsychiatric treatment when used in collaboration with the primary care they receive in the nursing home.

Detailed description: Individuals at the South Cove Manor nursing home will be referred to this study if they are experiencing depression. After meeting with the Principal Investigator (a psychiatrist), he will collaborate with the primary care physician and the nursing home staff to establish a treatment plan for the patient. Videoconferencing will be used by the P.I. for regular psychiatric visits with the patient as well as meetings with the nursing home staff to coordinate care for the patient. After collaboration between the two groups, treatment suggestions will be given to the patient's primary care physician (PCP) to implement in the primary care setting. The patient's symptomology, mood, satisfaction of life and side effects of medication will be recorded regularly to measure the effects of treatment for analysis.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Major Depressive Disorder
* Patient at South Cove Manor Nursing Home
* Referred by nursing staff for psychiatric consultation

Exclusion Criteria:

* Not competent to participate in psychiatric interviews

Primary outcomes:
measure: Change in Mean Scores on Clinical Global Impressions
timeFrame: Baseline, 30 days or 60 days (length depended on clinical needs of patients)
measure: Patient/Family Telepsychiatry Service Satisfaction Survey
timeFrame: 30 days or 60 days (length depended on clinical needs of patients)
measure: Nurse Telepsychiatry Services Satisfaction Questionnaire
timeFrame: 30 days or 60 days (length depended on clinical needs of patients)
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Depression and Clinical Research Program at Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: South Cove Manor
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Albert Yeung, S., M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06616818: DASH Diet Intervention for Systemic Hypertension in Adolescents
Official title: DASH Diet Intervention for Systemic Hypertension in Adolescents
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypertension
Food Insecurity
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
First posted: 2024-09-27
Enrollment: 300
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 6 months of produce delivery.
Primary purpose: TREATMENT

Brief summary: Parallel randomized clinical trial comparing DASH produce home delivery to routine care for the management of elevated blood pressure and hypertension in adolescents.

Detailed description: Parallel randomized clinical trial comparing DASH produce home delivery to routine care for the management of elevated blood pressure and hypertension in adolescents.

Eligibility criteria: Inclusion Criteria:

Age 12 to 17 years of age at baseline visit Elevated blood pressure or hypertension

-

Exclusion Criteria:

Inability to eat by mouth Secondary hypertension

Primary outcomes:
measure: Change in vegetable and fruit intake
timeFrame: 12 weeks and 6months
Secondary outcomes:
measure: Systolic blood pressure
timeFrame: 12 weeks and 6 months
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Nemours Cardiac Center
state: Delaware
Study officials:
References: