louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06252948: Gut Microbiome Studies in Patients with POEMS Syndrome and Other Plasma Cell Disorders
Official title: Gut Microbiome Studies in Patients with POEMS Syndrome and Other Plasma Cell Disorders
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Plasma Cell Disorders
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-02-12
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: POEMS Syndrome and Other Plasma Cell Disorders

Brief summary: A Study to Evaluate Gut Microbiome with POEMS Syndrome and Other Plasma Cell Disorders

Detailed description: The characteristics and role of gut microbiome rare plasma cell disorders- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) and amyloid light-chain (AL) amyloidosis, have not been explored; and their pathophysiology is quite elusive. To help understand rare plasma cell disorders and its association with gut microbiome, the investigators will study the stool samples of newly diagnosed POEMS patients and AL amyloidosis and compare it with patients with newly diagnosed monoclonal gammopathy of undetermined significance and multiple myeloma as well as healthy controls. Moreover, gut microbiome in newly diagnosed POEMS patients will be compared to POEMS patients in remission. It is the overall hypothesis that in POEMS patients the gut microbiome signature will differ between active disease (at diagnosis) and inactive disease (in remission), and the gut microbiome in POEMS patients will be different from patients with other plasma cell disorders and healthy controls.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with POEMS syndrome (newly diagnosed or in remission) or with newly diagnosed multiple myeloma (MM), monoclonal gammopathy of undetermined significance (MGUS), amyloid light chain (AL) amyloidosis or healthy controls from their households

Exclusion Criteria:

* Age under 18 years
* Pregnancy
* Substance abuse
* Antibiotics use or gastrointestinal endoscopy in the 3 months prior to the study participation
* Chronic gastrointestinal disorder
* Gastrointestinal surgeries in the past 2 years
* Chemotherapy (including anti-plasma cell treatment and steroids) or radiation treatment for cancer within the last 2 years or active cancer (other than plasma cell disorder)

Primary outcomes:
measure: Gut Microbiome characteristics in patients with POEMS syndrome and other plasma cell disorders
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Angela Dispenzieri, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00875030: A Study Comparing Blood Levels After Single-Dose Administration Of Artesunate Sachets (Pfizer) Versus Single-Dose Administration Of Arsuamoon® Tablets (Guilin-China) In Healthy Subjects
Official title: A Single-Dose Bioequivalence Study Comparing Artesunate Sachets (Pfizer) To Arsuamoon® Tablets (Guilin-China) In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy Volunteers
Keywords: Bioequivalence study-artesunate sachets-arsuamoon tablet
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-04-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The primary objective of the study is to determine bioequivalence of 50 mg (2x25 mg) Artesunate Sachet (Pfizer) versus 50 mg (1x50 mg) tablet, Arsuamoon® (Guilin China) which is the World Health Organization Reference standard for artesunate The secondary objective is to assess the safety of Artesunate Sachet (Pfizer) and Arsuamoon® tablet (Guilin China).


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.
* Body Mass Index (BMI) of 18 to 30 kg/m2; and a total body weight \>45 kg (99 lbs).
* An informed consent document signed and dated by the subject or a legally acceptable representative.

Exclusion Criteria:

* Any condition possibly affecting drug absorption.
* A positive urine drug screen.
* Have a known history of hypersensitivity, allergy (except for untreated, asymptomatic, seasonal allergies at the time of dosing), severe adverse drug reaction, or intolerance to artesunate or its derivatives.

Primary outcomes:
measure: Cmax, AUCinf and AUClast, for DHA
timeFrame: 1 year
Secondary outcomes:
measure: Tmax and t1/2 for DHA; Cmax, AUCinf, AUClast, Tmax and t1/2 for artesunate.
timeFrame: 1 year
measure: Safety laboratory tests, vital signs, and adverse events.
timeFrame: 1 year
Other outcomes:
Locations:
city: Navi Mumbai
country: India
facility: Pfizer Investigational Site
state: Maharashtra
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05232448: The Effect of Cognitive Behavioral Therapy Education to Elderly Care Students on Outcome Measures
Official title: The Effect of Cognitive Behavioral Therapy Education to Elderly Care Students on Ageism, Attitudes to Elderly, Empathy and Body Image
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Behavioral Therapy
Ageism
Keywords: Elderly care
Ageism
Cognitive Behavioral Therapy
Empathy
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
First posted: 2022-02-09
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this study, to examine the effects of cognitive behavioral therapy education to elderly care students on ageism, attitudes towards the elderly, empathy and body image.

Detailed description: Students in the control group will continue their normal education. The students in the intervention group will be given training on ageism, elderly attitude, empathy and body image in the cognitive therapy training, which will be given by a psychological counselor who is an expert in the field and will last for a total of 1 month in four modules.

Eligibility criteria: Inclusion Criteria:

* Students who do not have hearing, speech and psychiatric problems that prevent communication
* Students who volunteered to participate in the study

Exclusion Criteria:

- Students who do not want to be involved in the study

Primary outcomes:
measure: Kogan Attitudes Toward Old People Scale
timeFrame: Change from Baseline Kogan Score at 1 month
measure: The Cognitive Affective and Somatic Empathy Scales (CASES) for Children
timeFrame: Change from Baseline CASES Score at 1 month
measure: Ageism Attitude Scale
timeFrame: Change from Baseline Ageism Attitude Scale at 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Muğla
country: Turkey
facility: Muğla Sıtkı Koçman University Vocational School of Health Services
state: Köyceğiz
Study officials:
affiliation: Koycegiz District Directorate of Social Services
name: Ramazan Dovan, BSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Ege University
name: İsmet Tümtürk, BSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03031548: Intra-op POCUS for Identification of Endotracheal Tube Position in the Pediatric Population
Official title: Intraoperative Point-of Care Ultrasound for Identification of Endotracheal Tube Position in the Pediatric Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endotracheal Tube Wrongly Placed During Anesthetic Procedure
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2017-01-25
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children who require general anesthesia and endotracheal intubation for procedures in the cardiovascular laboratory

Brief summary: Chest X-ray and/or fluoroscopy is not routinely used in the OR to confirm endotracheal tube (ETT) placement by anesthesiologists. Multiple studies have shown that \~19% of all intubations result in inappropriate ETT placement. An adult study has shown that ultrasound point-of-care is superior to auscultation in determining the location of ETT. This study aims to determine if point-of-care is useful in determining ETT position in children.

Detailed description: Patients scheduled to have a procedure in the cardiovascular laboratory where fluoroscopy is routinely used will also undergo a point-of-care ultrasound exam to determine endotracheal tube position. An anesthesiologist will perform the ultrasound exam.

Eligibility criteria: Inclusion Criteria:

1. children birth to 10 years of age;
2. undergoing cardiac catheterization in the cath lab;
3. general anesthesia with an endotracheal tube;
4. subjects will also receive a chest x-ray as standard of care

Exclusion Criteria:

1. children ages birth to 10 years undergoing cardiac catheterization under GA without an endotracheal tube;
2. emergency procedures;
3. known airway anomalies;
4. children who are non-English and non-Spanish speaking -

Primary outcomes:
measure: Endotracheal Tube Position
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Health
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Department of Anesthesiology
state: California
Study officials:
affiliation: Loma Linda University Health
name: Elizabeth Ghazal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03283748: Detection of Motor Seizures Using WBAN
Official title: Detection of Motor Seizures Using Wireless Body Area Network
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Seizures, Tonic-Clonic
Lead sponsor: Mohawk College
Sponsor class: OTHER
Collaborators: name: Hamilton Health Sciences Corporation
name: Toronto Metropolitan University
First posted: 2017-09-14
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to collect the motor movement data using sensors to detect Generalized Tonic Clonic Seizures . Wearable sensors similar to smart watches will be used to detect seizures. The proposed system will consist of 3-4 wearable wireless sensor worn on the hands and legs. The data from these sensors will be send to the clod and collected to a central hub for analysis and detection of GTC Seizures.

Detailed description: The key of the project is digital signal processing of the movement data collected. The medical application sensors from Analog Devices will be worn around the wrist and legs of the participants. These sensors will continuously collect the motor movement data. The data will be send to the cloud from where it will be collected at a central hub for digital signal processing and detection. The data analysis results will be compared with the standard EEG results for Tonic Clonic seizures and results will be verified.

Eligibility criteria: Inclusion Criteria:

* subject has seizures or symptoms of seizures

Exclusion Criteria:

Primary outcomes:
measure: Measurement of Acceleration
timeFrame: 3 months
Secondary outcomes:
measure: Digital Signal processing of the data
timeFrame: 3 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Mini Thomas
state: Ontario
Study officials:
affiliation: Mohawk College
name: Mini Thomas, M.Eng.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01459848: Baby Dvd Effects on Cortisol
Official title: A Randomized Controlled Trial of Block Play vs Dvd Viewing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Development
Keywords: Salivary cortisol measured after DVD watching or block play
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
First posted: 2011-10-26
Enrollment: 50
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The investigators will do an experiment where 9-12 month old infants are randomized to 30 minutes of block play or 30 minutes of watching a baby DVD.


Eligibility criteria: Inclusion Criteria:

* 9-12 months of age

Primary outcomes:
measure: salivary cortisol
timeFrame: Baseline
measure: salivary cortisol
timeFrame: 10 minutes post baseline
measure: salivary cortisol
timeFrame: 20 minutes post baseline
measure: salivary cortisol
timeFrame: 30 minutes post baseline
measure: salivary cortisol
timeFrame: 40 minutes post baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle CHildrens Research Institute
state: Washington
Study officials:
affiliation: Seattle Children's Hospital
name: Dimitri Christakis, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Christakis DA, Liekweg K, Garrison MM, Wright JA. Infant video viewing and salivary cortisol responses: a randomized experiment. J Pediatr. 2013 May;162(5):1035-40. doi: 10.1016/j.jpeds.2012.10.032. Epub 2012 Nov 16.
Clinical trial NCT02035930: Effect of Dexmedetomidine on Bispectral Index and Propofol Requirements During Different Menstrual Cycle
Official title: Effect of Dexmedetomidine on Bispectral Index and Propofol Requirements During Different Menstrual Cycle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Abnormal Menstrual Cycle
Keywords: Bispectral Index Monitor, Menstrual Cycle, Dexmedetomidine
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2014-01-14
Enrollment: 110
Sex: FEMALE
Minimum age (years): 24
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The study was done to evaluate the effects of the follicular and luteal phases of the menstrual cycle on sedation level at loss of consciousness and bispectral index reach to 50 during propofol anesthesia, in patients with and without preoperative intravenous dexmedetomidine .


Eligibility criteria: Inclusion Criteria:

* a regular menstrual cycle
* elective gynecologic surgery

Exclusion Criteria:

* pregnancy
* breastfeeding
* obesity
* known hypersensitivity to drugs used in the study protocol;
* use of psychotropic drugs and steroids within 72 hours before the surgery
* central nervous system injury
* renal impairment
* alcoholism and opioid addiction.

Primary outcomes:
measure: bispectral index at loss of eyelash reflex
timeFrame: up to 2 years
Secondary outcomes:
measure: propofol requirements from propofol administered to loss of eyelash reflex and bispectral index reduced to 50
timeFrame: up to 2 years
Other outcomes:
measure: duration from propofol administered to loss of eyelash reflex and bispectral index reduced to 50
timeFrame: up to 2 years
Locations:
Study officials:
References:
Clinical trial NCT06526130: Influence of Anaesthesia Type on Multiple Sclerosis Relapse
Official title: Multiple Sclerosis Comparison of Relapse Incidence After General and Neuraxial Anesthesia: a Retrospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
anaesthesia
relapse
Lead sponsor: Varazdin General Hospital
Sponsor class: OTHER
First posted: 2024-07-29
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study included adult patientswith multiple sclerosis diagnosis who had undergone general or neuraxial anesthesia in General Hospital Varaždin during the period from 01.01.2012 to 31.12.2022.

Brief summary: The influence of anesthesia on the course of multiple sclerosis is poorly investigated and the literature is limited.

The aim of this study is to investigate multiple sclerosis relapse after different types of anesthesia.

Detailed description: The influence of anesthesia on the course of multiple sclerosis is poorly investigated and the literature is limited. A possible relapse after neuraxial anesthesia, it is believed to be associated with local anesthetic's toxicity and concentration.

The aim of this study is to investigate multiple sclerosis relapse after different types of anesthesia.

Eligibility criteria: Inclusion Criteria:

* multiple sclerosis
* surgical procedure under general anaesthesia
* surgical procedure under neuraxial anaesthesia

Exclusion Criteria:

* patients (medical records) with incomplete data

Primary outcomes:
measure: Multiple sclerosis relapse after 1 month
timeFrame: 1 month
measure: Multiple sclerosis relapse after 3 months
timeFrame: 3 months
measure: Multiple sclerosis relapse after 6 months
timeFrame: 6 months
measure: Multiple sclerosis relapse after 12 months
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Varazdin General Hospital, Varazdin, Croatia
name: Monika Kocman Panic, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04377230: BP Limb Length of 60cm vs 100cm in Roux-en-Y Gastric Bypass
Official title: Impact of Biliopancreatic Limb Length of 60cm vs 100cm in Roux-en-Y Gastric Bypass on Bone Mineral Density 2 Years After Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Osteopenia
Lead sponsor: Hospital General Universitario Elche
Sponsor class: OTHER
Collaborators: name: Instituto de Seguridad Social del Estado de Mexico y Municipios
First posted: 2020-05-06
Enrollment: 200
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: DIAGNOSTIC

Brief summary: Patients will be randomized into 2 groups:

* Group 60: Patients will undergo a Roux-en-Y gastric bypass with a Biliopancreatic limb length of 60cm
* Group 100: Patients will undergo a Roux-en-Y gastric bypass with a Biliopancreatic limb length of 100cm

Bone mineral density will be evaluated before surgery and 2 years after it.

Detailed description: Patients will be randomized into 2 groups:

* Group 60: Patients will undergo a Roux-en-Y gastric bypass with a Biliopancreatic limb length of 60cm
* Group 100: Patients will undergo a Roux-en-Y gastric bypass with a Biliopancreatic limb length of 100cm Alimentary limb will be constant in both groups (150cm length)

Bone mineral density will be evaluated before surgery and 2 years after it, by means of X ray absorptiometry (DEXA). Changes in bone mineral density in lumbar column will be assessed.

Eligibility criteria: Inclusion Criteria:

* Body mass index \>40 Kg/m2
* Body mass index \>35 Kg/m2 associated to obesity related comorbidities

Exclusion Criteria:

* Bone pathologies
* Active neoplasms
* Disorders in calcium or vitamin D metabolism

Primary outcomes:
measure: Bone mineral density
timeFrame: 2 years after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Garcilaso Clinic
name: Jaime Ruiz-Tovar
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05270330: Plaque Stability and Metabolomics in Coronary Heart Disease
Official title: The Relationship Between Plaque Stability Evaluated by IVUS and Metabolomics in Stable Coronary Heart Disease Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Keywords: plaque stability
metabonomics
Lead sponsor: Shaanxi Provincial People's Hospital
Sponsor class: OTHER
First posted: 2022-03-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with stable coronary heart disease and assessed for plaque stability by IVUS will be recruited in our study.

Brief summary: At present, the investigators don't know the relationship between plaque stability and the metabonomics changes. In the present study, investigators will evaluate the plaque stability by intravascular unltrasound in stable coronary heart patients, and metabonomics was also assessed by high throughput sequencing. Statistic analysis were carried out to analyze the correlation between plaque stability and metabonomics changes among these study patients.


Eligibility criteria: Inclusion Criteria:

* Patients who diagnosed with stable coronary heart disease and evaluated for plaque stability by IVUS will be recruited.

Exclusion Criteria:

* renal insufficiency with serum creatinine \> 20 mg/L;
* regnant/lactating women, or the women receive hormone replacement therapy in premenopausal or postmenopausal;
* patients have a history of abusing alcohol or other drugs in the past two years, active hepatitis, cirrhosis;
* endocrine abnormalities without therapy (diabetic ketoacidosis, thyroid disease, etc.);
* The body's inflammatory disease, rheumatoid arthritis, osteoarthritis, ulcerative bowel disease, systemic lupus erythematosus (sle), etc.), myositis/myopathy, cancer;
* Dilated cardiomyopathy, valvular heart disease, persistent atrial fibrillation;
* patients recently injured;（8）Other researchers don't agree to join this study.

Primary outcomes:
measure: Plaque stability
timeFrame: 07/01/2021-07/31/2024
Secondary outcomes:
measure: Metabonomics
timeFrame: 07/01/2021-07/31/2024
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Shaanxi Provincial People's Hospital
state: Shaanxi
Study officials:
References:
Clinical trial NCT00579930: Cytogenetic and Molecular Genetic Studies in Bone Sarcomas
Official title: Cytogenetic and Molecular Genetic Studies in Bone Sarcomas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: Bone
Soft Tissue
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2007-12-24
Enrollment: 1
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: Primary Care Clinic

Brief summary: To establish a serial ascertainement of specimens from patients with bone sarcomas to be used in ongoing cytogenetic and molecular genetic analyses. These data will be integrated and correlated with the established Orthopaedic Service clinical database.


Eligibility criteria: Inclusion Criteria:

* Patients must be undergoing diagnostic biopsy or resection of their primary or metastatic bone sarcoma for therapeutic purposes.
* The specimen must be large enough to allow routine pathological analysis, with the specimen for research excised from residual tissue that would otherwise be discarded.

Exclusion Criteria:

* N/A

Primary outcomes:
measure: To establish a serial ascertainement of specimens from patients with bone sarcomas to be used in ongoing cytogenetic and molecular genetic analyses.
timeFrame: conclusion of study
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Marc Ladanyi, MD
role: PRINCIPAL_INVESTIGATOR
References: