louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00196430: Study About Effectiveness of Silver-Containing Textiles for Treatment of Acute Neurodermatitis
Official title: Prospective, Controlled Three-Armed Study About Effectiveness and Compatibility of Silver-Containing Textiles for Treatment of Acute Neurodermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neurodermatitis
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
Collaborators: name: Julius Zorn GmbH, Aichach, Germany
First posted: 2005-09-20
Enrollment: 32
Sex: ALL
Minimum age (years): 2
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate whether the treatment of acute neurodermitis with silver-contained textiles is equivalent or more effective to the conservative exogenous treatment with a corticosteroid. Secondary aim is to define skin comfortability of the textiles.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of acute Neurodermitis
* Age: 2-70 years
* Patients are mobile
* Patient's information and willingness to participate

Exclusion Criteria:

* Acute viral infection (herpes zoster, eczema herpeticum)
* Acute staphylodermas
* Other skin-diseases affecting outcomes of intervention (e.g. psoriasis)
* Current UV-Treatment
* Current other immunosuppressive or immunomodulated Therapy
* Current antimicrobial Therapy (e.g. antibiotics)
* Severe general diseases (e.g. melanoma, renal insufficiency, autoimmune diseases)
* Pregnancy
* Fertile females without effective contraception

Primary outcomes:
measure: SCORAD at days -3,0,7,14,28,56 for every group
Secondary outcomes:
measure: Influence of silver containing textiles in reducing bacterial skin colonization (especially Staph. aureus)
measure: Consumption of corticosteroids at days 0-28
measure: Consumption of corticosteroids at days 28-56
measure: Pruritus under textiles
measure: Evaluation of quality of life
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: Clinic and Polyclinic of Dermatology, Ernst-Moritz-Arndt-University of Greifswald
state: Fleischmannstr. 42-44
Study officials:
affiliation: Clinic and Polyclinic of Dermatology, University of Greifswald
name: Michael Jünger, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinic and Polyclinic of Dermatology, University of Greifswald
name: Andrea Ladwig
role: STUDY_CHAIR
References:
Clinical trial NCT06283030: Evaluation of Hypoglossal Nerve Stimulation in Humans With Obstructive Sleep Apnea
Official title: Acute Proof-of-Concept Study to Evaluate Hypoglossal Nerve Stimulation in Humans With Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Sleep Disorder
Lead sponsor: Invicta Medical Inc.
Sponsor class: INDUSTRY
Collaborators: name: Vanderbilt University Medical Center
First posted: 2024-02-28
Enrollment: 14
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This proof-of-concept study is being performed to evaluate whether the hypoglossal nerve can be stimulated using a small series of electrodes placed surgically via a percutaneous approach. Minimally invasive off the shelf medical devices will be used and observation of the characteristic physiological responses to stimulation of the HGN, will be assessed.


Eligibility criteria: Inclusion Criteria:

* Subject must be eligible for an OSA diagnostic or surgical procedure.
* Subject suffers with moderate to severe OSA based on history and a physical exam.
* Subject has failed, refused or has not tolerated CPAP treatment.
* Subject is willing and capable of providing informed consent.
* Subject is willing to have a representative electrode array temporarily placed in the submandibular, sublingual and mylohyoid space.

  --Subject is willing to participate in the designated follow-up visits.
* Subject must be in good general health.
* Subject is able to understand and has voluntarily signed and dated the IRB or EC approved informed consent form (ICF) prior to initiation of any screening or study-specific procedure.
* Subject must be minimum of 21 years and maximum 80 years of age.
* Subject's Hypoglossal Nerve must be able to be visualized using ultrasound

Exclusion Criteria:

* Subject has Body Mass Index above 38kg/m2.
* Subject has had surgical resection or radiation therapy for cancer or congenital malformations in the larynx, tongue, or throat.
* Subject has significant co-morbidities making them unable or inappropriate to participate in this POC study.
* Subject plans to become pregnant, is currently pregnant or breastfeeding during the study period.

Primary outcomes:
measure: Identification and access of the target outcomes
timeFrame: Day 0
measure: Tongue protrusion outcomes
timeFrame: Day 0
measure: Characterization of electrode array outcomes
timeFrame: Day 0
measure: Electrode array placement and removal outcomes
timeFrame: Day 0
measure: Safety outcomes
timeFrame: Day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt Bill Wilkerson Centre
state: Tennessee
Study officials:
References:
Clinical trial NCT00171925: Therapy With Zoledronic Acid in Patients With Multiple Myeloma Stage I
Official title: Therapy With Zoledronic Acid in Patients With Multiple Myeloma Stage I
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Multiple Myeloma Stage I
Keywords: Multiple Myeloma
Stage I
Zoledronic acid
Progression
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 143
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: Multiple myeloma is a disease of B-lymphocytes producing malignant plasma cells. Malignant plasma cells induce osteolytic lesions, which is characteristic for progression of multiple myeloma. It is the aim of this study to investigate whether zoledronic acid has an influence on the progression of multiple myeloma.


Eligibility criteria: Inclusion Criteria

* Evidence of myeloma according to the criteria of the British Columbia Cancer Agency (for the diagnosis, 2 of the 3 criteria must be met):

  * Evidence of paraprotein in the serum or urine
  * Bone marrow infiltration with plasma cells which represent more than 10% of the nucleated cells
  * Radiologically, at least one osteolytic lesion
* Asymptomatic patients with Stage I (Durie and Salmon) multiple myeloma

Exclusion criteria:

* Patients with more than one osteolytic lesion on conventional skeletal radiography
* Previous treatment with bisphosphonates
* bilirubin \> 2.5 mg/dl
* Abnormal renal function as evidenced by: A calculated creatinine clearance \< 30 ml/minute. Creatinine clearance (CrCl) is calculated using the Cockcroft-Gault formula:

  * CrCl= \[140-age(years)\] x weight(kg)/\[72xserumcreatinine(mg/dL)\] X {0.85 for female patients}
* Patients with other malignant diseases or severe concomitant diseases
* Potentially fertile patients who are not using a reliable and appropriate method of contraception
* Pregnancy or breast-feeding
* Participation in another clinical study with an investigational drug within 12 weeks of study entry
* Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.
* Recent (within 6 weeks) or planned dental or jaw surgery (e.g.. extraction, implants)

Other protocol-defined inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Days of Progression Free Survival
timeFrame: 48 months
Secondary outcomes:
measure: Number of Patients With Progression by Individual Criteria
timeFrame: 48 months
measure: The Number of Participants With the Development of Skeletal Complications
timeFrame: 48 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT01417325: Beijing Percutaneous Coronary Intervention Registry
Official title: A Registry Study of Percutaneous Coronary Intervention Treatment in Beijing Area of P.R. China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Heart Disease
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2011-08-16
Enrollment: 700000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the patients receiving coronal artery angiography or percutaneous coronary intervention therapy in selected 48 hospitals of Beijing, P.R.China.

Brief summary: The registry study is to obtain the state of the art of the percutaneous coronary intervention state treatment for coronary heart disease in Beijing area of P.R.China in a real world. The data are collected from 48 hospitals in Beijing area using an uploading system through internet.


Eligibility criteria: Inclusion Criteria:

* Patients from selected 48 hospitals of Beijing, P.R.China
* Patients receiving coronal artery angiography or percutaneous coronary intervention therapy

Exclusion Criteria:

* none

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing cardiovascular intervention quality control and improvement center
state: Beijing
Study officials:
affiliation: Fuwai Heart Hospital & Cardiovascular Institute
name: Yuejin Yang, doctor
role: STUDY_CHAIR
References:
Clinical trial NCT02029625: Compare the Pharmacokinetics of NVP-1205 and Coadministration of Rosuvastatin and Ezetimibe
Official title: A Clinical Trial to Compare the Pharmacokinetics and Safety of NVP-1205 and Coadministration of Rosuvastatin and Ezetimibe in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dyslipidemia
Lead sponsor: NVP Healthcare
Sponsor class: INDUSTRY
First posted: 2014-01-08
Enrollment: 41
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief summary: The purpose of this study is to compare the pharmacokinetics of NVP-1205 and coadministration of rosuvastatin and ezetimibe.

Detailed description: rosuvastatin and ezetimibe(anti-dyslipidemia)

Eligibility criteria: Inclusion Criteria:

* Healthy male subjects age between 19 and 55 signed informed consent

Exclusion Criteria:

* subjects have a history of allergy reaction of this drug or other drugs

Primary outcomes:
measure: AUClast
timeFrame: 0-96hr
Secondary outcomes:
measure: AUCinf
timeFrame: 0-96hr
Other outcomes:
Locations:
city: Jung-gu
country: Korea, Republic of
facility: Kyungpook National Hospital
state: Daegu
Study officials:
affiliation: Kyungpook National University Hospital
name: Yoon Yo Ran, M.D., Ph,D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03306225: Characterization of Endocarditis to Streptococci and Impact of the CMI on the Future of the Patients
Official title: Characterization of Endocarditis to Streptococci and Impact of the CMI on the Future of the Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endocarditis, Bacterial
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2017-10-10
Enrollment: 414
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all patient diagnostised for endocarditis between 2010 and 2015

Brief summary: The infectious endocarditis is a grave infection the incidence of which is at present esteemed at 30-100 episodes by million inhabitants a year.

This infection is marked with a heavy morbi-mortality.Preliminary studies seem to show an abnormally high death rate at the patients presenting an infectious endocarditis to streptococci with an inhibitive minimal concentration raised to the amoxicilline. The aim of the study is to describe the epidemiology and the clinical presentations of the patients presenting an endocarditis to streptococci


Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* endocartitis with steptococci with Duke's criteria

Exclusion Criteria:

* age \< 18 years
* suspiscious endocarditis without Duke's criteria

Primary outcomes:
measure: Evaluation of factors associated to the mortality in the patients presenting an endocarditis to streptococci.
timeFrame: an average of one year
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: PILMIS P Benoit, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03061825: Zenith Alpha™ Abdominal Endovascular Graft
Official title: Post-Market Study for Zenith Alpha™ Abdominal Endovascular Graft
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Aortic
Aorto-iliac Aneurysm
Keywords: Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Iliac Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2017-02-23
Enrollment: 100
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: Potential study patients with abdominal aortic or aorto-iliac aneurysm will be "screened " at the hospital.

Brief summary: The purpose of this study is to evaluate the clinical performance of the Zenith Alpha™ Abdominal Endovascular Graft for the treatment of abdominal aortic or aorto-iliac aneurysm.


Eligibility criteria: Inclusion Criteria:

* A patient is considered eligible for inclusion in the study if the patient has an infrarenal abdominal aortic or aorto-iliac aneurysm and is intended to be treated with the Zenith Alpha™ Abdominal Endovascular Graft

Exclusion Criteria:

* Life expectancy less than (\<) 2 years
* Inability or refusal to give informed consent by the patient or legally authorized representative
* Unwilling or unable to comply with the study follow-up

Primary outcomes:
measure: Device Success
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver Hospital and Health Science Center
state: British Columbia
city: Halifax
country: Canada
facility: Nova Soctia Health Authority
state: Nova Scotia
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Center
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: Toronto General Hospital
name: Thomas Forbes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03079648: Efficacy and Safety of Angelica Gigas N. Extract on Improvement of Blood Triglyceride
Official title: A 12-week, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Angelica Gigas N. Extract on Improvement of Blood Triglyceride
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperlipidemias
Keywords: Angelica gigas N. extract
Hyperlipidemia
Clinical Trial
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2017-03-14
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was conducted to investigate the effects of daily supplementation of Angelica gigas N. extract on improvement of Blood Triglyceride.

Detailed description: This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. Twenty subjects were randomly divided into Angelica gigas N. extract or a placebo group. Fasting triglyceride profiles before and after the intervention.

Eligibility criteria: Inclusion Criteria:

* Age 19-80 years with Triglyceride 130-200 mg/dL

Exclusion Criteria:

* Lipid lowering agent within past 6 months
* Severe cardiovascular disease(Mvocardial infarction, Stroke, etc)
* Renal disease(Heredity hyperlipidemia, Acute/Chronic renal failure, Nephrotic syndrome, etc)
* Cancer, Respiratory organ disease(Asthma, Chronic obstructive pulmonary disease)
* Autoimmune disease
* Diabetes mellitus
* Allergic or hypersensitive to any of the ingredients in the test products
* History of disease that could interfere with the test products or impede their absorption
* Under antipsychotic drugs therapy within past 2 months
* History of alcohol or substance abuse
* Participation in any other clinical trials within past 2 months
* Laboratory test by show the following results

  * aspartate aminotransferase, alanine aminotransferase \> Reference range upper limit treble
  * Serum Creatinine \> 2.0 mg/dl
* Pregnancy or breast feeding
* Not Contraception(except: Surgery for female infertility)

Primary outcomes:
measure: Changes of Triglyceride
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes of Lipid profile
timeFrame: 12 weeks
measure: Changes of Arteriosclerosis index
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Clinical Trial Center for Functional Foods Chonbuk National University Hospital
state: Jeollabuk-do
Study officials:
References:
Clinical trial NCT05216848: Prevalence and Risk Factors for Serious Birth Concerns in Unselected Population of Mothers
Official title: Prevalence and Risk Factors for Serious Birth Concerns in Unselected Population of Mothers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Serious Concerns
Keywords: fear of childbirth
Wijma Delivery Expectancy Questionnaire
Lead sponsor: Comenius University
Sponsor class: OTHER
First posted: 2022-02-01
Enrollment: 700
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Total 700 nullipara and multipara giving birth at 2nd Department of Obstetrics and Gynecology, University Hospital Bratislava and Comenius University, Bratislava, Slovak Republic in a period of two years

Brief summary: The aim of this study is to determine the prevalence of significant concerns about childbirth and their impact on the course and outcome of childbirth. By identifying a group of mothers who have an excessive fear of childbirth, the occurrence of surgical births can be influenced by the right intervention.

Detailed description: The fear of childbirth is one of the most common mental health concerns during pregnancy. Elevated levels of anxiety during childbirth may lead to increased risk of elective caesarean section or prolonged labour. About 80% of pregnant women suffer from certain kind of childbirth fear. The most commonly used tool for assessment and diagnosis of childbirth fear is Wijma Delivery Expectance Questionnaire (WDEQ). This questionnaire has been translated and validated into several languages. In 2020 the Slovak version of the questionnaire was validated. All women who completed antenatal counseling at 36 weeks of gestation were included in the cohort. A slovak version of questionnaire was issued to all women and the results were recorded in the protocol. Subsequently, demographic data, medical facts and childbirth outcome were added from the medical documentation. The results of the birth were compared with the results of the questionnaire.

Eligibility criteria: Inclusion Criteria:

* The investigators involve every nullipara and multipara giving birth at 2nd Department of Obstetrics and Gynecology, University Hospital Bratislava and Comenius University, Bratislava, Slovak Republic in a period of two years

Exclusion Criteria:

* unwilling to participate, minors (under 18 years old), high risk pregnancy, foetus mortus or perinatal death of the newborn, with slovak language, previous Caesarean section (for multipara)

Primary outcomes:
measure: Significant fear of childbirth
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Bratislava
country: Slovakia
facility: 2nd Department of Obstetrics and Gynecology, University Hospital Bratislava and Comenius University, Bratislava, Slovak Republic
state: Slovak Republic
Study officials:
References:
Clinical trial NCT06030648: MT2022-01: MSCs for ALD
Official title: Intravenous Administration of Mesenchymal Stem Cells (IV-MSC) for the Treatment of Cerebral Adrenoleukodystrophy (cALD)
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
Conditions: Cerebral Adrenoleukodystrophy
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 10
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a single-institution study to evaluate the use of intravenously administered allogeneic, 3rd party mesenchymal stem cells (IV-MSC) in patients with active, cerebral adrenoleukodystrophy (CALD), as a bridge to hematopoietic stem cell transplant or gene therapy, or in patients who are too advanced for gene therapy or HSCT. The intervention will occur in the time between diagnosis of active CALD and transplant which is currently 8-12 weeks.


Eligibility criteria: Inclusion Criteria:

* age ≥ 3 years
* diagnosis of ALD, as established by elevation of very long chain fatty acid levels or gene mutation
* evidence of active cerebral disease as determined by the presence of gadolinium enhancement
* ALD MRI (Loes) score ≥ 1
* Patients who have not received prior gene therapy or transplant
* Life expectancy of \> 6 months as determined by the enrolling researcher
* Have adequate organ function confirmed by laboratory values obtained within 28 days prior to enrollment

Exclusion Criteria:

* Inability to undergo sedation or MRI studies for any reason
* Other concurrent life-threatening disease (life expectancy \<6 months) or eligible for hospice care
* Known or suspected hypersensitivity to human serum albumin, diphenhydramine, acetaminophen, methylprednisolone, or any of the components of IMS001.

Primary outcomes:
measure: Safety and tolerability of intravenously-administered allogeneic, third-party mesenchymal stem cells (IV-MSC).
timeFrame: 6 months
Secondary outcomes:
measure: Incidence of radiographic response in patients receiving intravenously-administered allogeneic, third-party mesenchymal stem cells (IV-MSC).
timeFrame: 6 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Masonic Cancer Center, University of Minnesota
state: Minnesota
Study officials:
References: