louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05936320: Evaluating the Effects of Information Leaflets in Adult Aural Rehabilitation
Official title: A Randomised Controlled Trial Evaluating Hearing Aid Knowledge and the Effects of Information Leaflets With and Without Illustrations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Impairment
Keywords: aural rehabilitation
hearing aid functions
hearing aid knowledge
information leaflet
visual aids
Lead sponsor: Horselvarden Region Ostergotland
Sponsor class: OTHER
First posted: 2023-07-07
Enrollment: 61
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: Knowledge about how to manage hearing aids is an important factor in hearing aid success, but studies show that this knowledge ranges from good to poor, even among experienced adult hearing aid users. Information leaflets is a common tool in healthcare to give information with the purpose to increase theoretical knowledge and change behaviour, and illustrations in these leaflets can provide additional understanding for all kinds of patients.

The primary aim of this aural rehabiliation study was to evaluate participants' knowledge about placement in a noisy environment, directional microphone and telecoil function at baseline and postintervention and assessing their perceptions of the benefits of an information leaflet. Additional aim was to investigate whether, an information leaflet with illustrations and accompanying text about hearing aid functions have additional effects on participants' knowledge compared to an information leaflet without illustrations.


Eligibility criteria: Inclusion Criteria:

* Adults (18-80 years old) with hearing aids from 2012 or later

Exclusion Criteria:

* Hearing aids without possibility to have activated directional microphones and telecoil
* non-swedish speaking (e.g. need interpreter)

Primary outcomes:
measure: Knowledge about hearing aid functions
timeFrame: Baseline, 3 weeks postintervention
measure: Perceived benefit
timeFrame: 3 weeks postintervention
Secondary outcomes:
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Hearing Clinic of the University Hospital Region Ostergotland
state: Östergötland
Study officials:
affiliation: Horselvarden Region Ostergotland
name: Marie Öberg
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00166920: Measurement of Cerebral Oxygen Extraction Fraction Using MRI Technique
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-14
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: All images in this study were acquired on a 1.5 T Sonata whole body scanner (Siemens Medical Inc., Erlangen, Germany) using 2D multi-echo gradient echo/spin echo sequence and 2D single-shot gradient echo-planar imaging sequence plus intravenous magnetic susceptibility contrast medium. The quantitative estimates and mapping of cerebral metabolic rate of oxygen utilization were calculated and plotted in all subjects.

Detailed description: All images in this study were acquired on a 1.5 T Sonata whole body scanner (Siemens Medical Inc., Erlangen, Germany) using 2D multi-echo gradient echo/spin echo sequence and 2D single-shot gradient echo-planar imaging sequence plus intravenous magnetic susceptibility contrast medium. The quantitative estimates and mapping of cerebral metabolic rate of oxygen utilization were calculated and plotted in all subjects.

Eligibility criteria: Inclusion Criteria:

* normal volunteer
* stroke

Exclusion Criteria:

* who is unable receiving MRI examination
* pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
state: province of Taiwan
Study officials:
affiliation: National Taiwan University Hospital
name: Hon-Man Liu, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03861520: Ultrasonographic Fetal Soft Markers and Aneuploidy
Official title: Correlation Between Ultrasonographic Fetal Soft Markers and Aneuploidy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Soft Markers
Keywords: Anomaly scan
Anuploidy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-03-04
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant Women at (16-24) weeks of gestation for mid trimester anomaly scan with one sonographic fetal soft marker or more

Brief summary: The purpose of this study is to investigate the prevalence of soft markers which will be identified during a second trimester ultrasound. Secondary aims were to estimate the association between the soft markers and trisomies 13, 18 and 21 as well as the effect on the number of invasive tests will be performed.


Eligibility criteria: Inclusion Criteria:

1. pregnant woman between (16-24) weeks of gestation.
2. singelton pregnancy.

Exclusion Criteria:

1. Multiple pregnancies.
2. Mental condition rendering the patients unable to understand the nature and scope of the study.

Primary outcomes:
measure: To study the association between soft markers identified at second trimester ultrasound and aneuploidy.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: Maha M Mossad, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00124020: Comparison of Telavancin and Vancomycin for Hospital-acquired Pneumonia Due to Methicillin-resistant Staphylococcus Aureus
Official title: A Phase 3, Randomized, Double-Blind, Parallel-Group, Multinational Trial of Intravenous Telavancin Versus Vancomycin for Treatment of Hospital-Acquired Pneumonia With a Focus on Patients With Infections Due to Methicillin-Resistant Staphylococcus Aureus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bacterial Pneumonia
Lead sponsor: Cumberland Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-07-26
Enrollment: 771
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: Study 0019 (NCT00124020) compares the safety and effectiveness of an investigational drug, telavancin, with vancomycin for the treatment of hospital-acquired pneumonia.


Eligibility criteria: Inclusion Criteria:

* Clinical signs and symptoms consistent with pneumonia acquired after at least 48 hours of continuous stay in an inpatient acute or chronic care facility or acquired within 7 days after being discharged from a hospitalization of greater than or equal to 3 days duration.

Exclusion Criteria:

* Received more than 24 hours of potentially effective systemic (IV, IM or PO) antibiotic therapy for Gram-positive pneumonia immediately prior to randomization.

Primary outcomes:
measure: Clinical Response
timeFrame: 7-14 days following end of antibiotic treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center, Infectious Disease Unit
Study officials:
affiliation: Duke University
name: G. Ralph Corey, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McKinnell JA, Corman S, Patel D, Leung GH, Gordon LM, Lodise TP. Effective Antimicrobial Stewardship Strategies for Cost-effective Utilization of Telavancin for the Treatment of Patients With Hospital-acquired Bacterial Pneumonia Caused by Staphylococcus aureus. Clin Ther. 2018 Mar;40(3):406-414.e2. doi: 10.1016/j.clinthera.2018.01.010. Epub 2018 Feb 15.
citation: Smart JI, Corey GR, Stryjewski ME, Wang W, Barriere SL. Assessment of Minimum Inhibitory Concentrations of Telavancin by Revised Broth Microdilution Method in Phase 3 Hospital-Acquired Pneumonia/Ventilator-Associated Pneumonia Clinical Isolates. Infect Dis Ther. 2016 Dec;5(4):535-544. doi: 10.1007/s40121-016-0133-y. Epub 2016 Oct 7.
citation: Barriere SL, Stryjewski ME, Corey GR, Genter FC, Rubinstein E. Effect of vancomycin serum trough levels on outcomes in patients with nosocomial pneumonia due to Staphylococcus aureus: a retrospective, post hoc, subgroup analysis of the Phase 3 ATTAIN studies. BMC Infect Dis. 2014 Apr 4;14:183. doi: 10.1186/1471-2334-14-183.
Clinical trial NCT01227720: Comparative Pharmacokinetic Study of New Oral Nicotine Replacement Therapy Products.
Official title: Comparative Pharmacokinetic Study of New Oral Nicotine Replacement Therapy Products - A Study in Healthy Smokers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Dependence
Keywords: Smoking Cessation, Nicotine pharmacokinetics
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2010-10-25
Enrollment: 104
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Comparative pharmacokinetic study of new oral nicotine replacement therapy products.

Detailed description: This study compares new oral Nicotine Replacement Therapy (NRT) products containing 2 and 4 mg nicotine with NiQuitin™ lozenge 2 mg and 4 mg, after 12 hours of nicotine abstinence, with respect to nicotine pharmacokinetics, during 12 hours after start of administration. Single doses of treatment A, B, C, and D are given once in the morning during separate treatment visits scheduled in a crossover setting with randomized treatment sequences, also including a fifth treatment visit with either treatment E or F. The study will include 104 healthy smokers between the ages of 19 and 50 years, who have been smoking at least 10 cigarettes daily during at least one year preceding inclusion. The study will be performed at two sites with 52 subjects at each site. Subjects and study personnel will be aware of which treatment is administered at a given visit.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects, smoking at least 10 cigarettes daily during at least one year preceding inclusion and BMI between 17.5 and 30.0 kg/m2.
* Female participants of child-bearing potential are required to use a medically acceptable means of birth control.
* A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Pregnancy, lactation or intended pregnancy.
* Treatment with an investigational product or donation or loss of blood within 3 month preceding the first dose of study medication.

Primary outcomes:
measure: Maximum Plasma Concentration
timeFrame: during 12 hours after product administration
measure: Area under the Curve
timeFrame: after 12 hours
Secondary outcomes:
measure: Time of Maximum Concentration
timeFrame: during 12 hours after start of product administration
measure: Terminal Elimination Rate Constant
timeFrame: during 12 hours after start of product administration
measure: Oral Dissolution Time
timeFrame: from administration until completely dissolved
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Lund University Hospital Clinical Trial Unit
city: Lund
country: Sweden
facility: McNeil AB Clinical Pharmacology R&D
Study officials:
affiliation: McNeil AB
name: Elisabeth Kruse, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05568420: A Study of the Possible Effects of Medication on Young Onset Colorectal Cancer (YOCRC)
Official title: Investigation of the Potential Effects of Pharmacologic Agents on Young Onset- Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer
Keywords: Pharmacologic
Colectomy specimens
22-254
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Shaare Zedek Medical Center
name: Technion, Israel Institute of Technology
First posted: 2022-10-05
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential research subjects will be identified through the Center for Young Onset Colorectal and Gastrointestinal Cancer, a member of the patient's treatment team, the principal and coprincipal investigator, or research team at Memorial Sloan Kettering Cancer Center (MSKCC).

Brief summary: This study will collect biospecimens (including blood, tissue, and stool samples) and health information to create a database-a type of collection of information-for better understanding young onset colorectal cancer (YOCRC). The study will include both people with YOCRC and healthy people.


Eligibility criteria: Inclusion Criteria:

CRC Cohort:

* 18-49 years old
* Histological or cytological diagnosis of colorectal adenocarcinoma
* Planned CRC resection biopsy, or colonoscopy ,including surveillance colonoscopies and/or have already undergone prior surgical resection, with tissue, including normal colonic mucosae distant from the malignant tumor (only patients providing tissue sample)
* Enrollment in IRB# 20-315, Young Onset Gastrointestinal Cancer Prospective Registry (Andrea Cercek, PI)

Healthy Control Cohort:

* 18-49 years old at time of diagnosis
* Scheduled for standard-of-care colonoscopy at MSK
* Underwent surgical resection of a traumatic injury to the colon at Shaare Zedek Medical Center (SZMC)

Exclusion Criteria:

* CRC Cohort:
* Antibiotic use within 6 months of collection of stool for gut microbiome analysis s (only patients providing stool sample)
* Known inherited cancer susceptibility gene
* History of inflammatory bowel disease

Healthy Control Cohort:

* Antibiotic use within 6 months of collection of stool for gut microbiome analysis (only patients providing stool sample)
* History of or prior treatment for cancer ≤ 5 years prior to registration. Exceptions include non-melanoma skin cancer, ductal carcinoma in situ, bladder carcinoma in situ, or carcinoma-in-situ of the cervix.
* Colonoscopy for indications of IBD, anemia and/or genetic predisposition (only patients providing tissue sample).

Primary outcomes:
measure: genomic analysis of tissue
timeFrame: 3 years
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: Andrea Cercek, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01099020: Temporal Pattern of Circulating DNA for Patients Receiving Irradiation
Official title: Temporal Pattern of Circulating DNA for Patients Receiving Total Body Irradiation
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Radiation
Keywords: Subjects receiving large volumes of Radiation
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2010-04-06
Enrollment: 13
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: Patients receiving large volume of radiation for the treatment of their cancer

Brief summary: The purpose of the research study is to test a measurement tool that will determine the radiation dose people receive when they have been accidentally exposed to radiation. This test will be done using a small amount of blood and known dose of radiation.


Eligibility criteria: Inclusion Criteria:

* Patient must be scheduled to undergo Total Body Irradiation (TBI) as part of a conditioning regime for a Bone Marrow Transplant. OR, Be scheduled to undergo Radiation Therapy treatment for a malignancy or other disease and have a radiation treatment field that contains at least 2 liters of tissue receiving at least 2 Gy radiation dose over the first 5 days of treatment.
* Patient must be willing to have blood draws as defined below.
* Patient must provide study-specific informed consent prior to study entry.
* Hemoglobin≥8.
* Age ≥ 18, but not older than age 60.

Exclusion Criteria:

* Patients not meeting the above inclusion criteria.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
References:
Clinical trial NCT04472520: Use of AliveCor ECG Monitoring to Replicate ECG Lead Recording
Official title: Use of AliveCor ECG Monitoring to Replicate ECG Lead Recording
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Arrhythmia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-07-15
Enrollment: 0
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: The researchers are trying to determine whether the Alivecor device can simulate other electrocardiogram (ECG) leads to record electrical activity.


Eligibility criteria: Inclusion Criteria:

* Individuals greater than 18 years old getting an ECG

Exclusion Criteria:

* Patients unwilling or unable to provide informed consent

Primary outcomes:
measure: Electrocardiogram (ECG) QT Interval
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Dan Sorajja, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01277120: An Observational Study on The Correlation Between Time of Initiation of Avastin (Bevacizumab) Treatment And Progression-Free Survival in Patients With Colorectal Cancer (CRONOS 1)
Official title: The Correlation Between the Moment of Bevacizumab theRapy initiatiOn and the Efficacy in patieNt With cOlorectal Cancer Treated With AvaStin Based First Line Regimens (CRONOS 1)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Colorectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-01-14
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: First-line treatment with Avastin

Brief summary: This single arm, prospective, observational study will assess the correlation between the time from start of chemotherapy to the start of Avastin (bevacizumab) treatment with progression-free survival in patients with previously untreated metastatic colorectal cancer. Patients will be followed for up to 12 months after progressive disease occurs.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= the 18 years of age
* Previously untreated metastatic colorectal cancer
* Scheduled to start 1st line chemotherapeutic treatment
* ECOG performance status 0-1

Exclusion Criteria:

* Any conditions included in contraindication list for Avastin
* Prior chemotherapy for metastatic colorectal cancer
* Adjuvant/neoadjuvant chemotherapy or radio-chemotherapy of non-metastatic colorectal cancer completed \<6 months prior to treatment start

Primary outcomes:
measure: Correlation of the time from the start of chemotherapy to the start of Avastin treatment with progression-free survival
timeFrame: 60 months
Secondary outcomes:
measure: Overall survival
timeFrame: 60 months
measure: Safety: Incidence of adverse events
timeFrame: 60 months
Other outcomes:
Locations:
city: Bucharest
country: Romania
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04910620: The Evaluation of TCI378 and TCI507 Probiotics on Weight-lowering Efficacy in Adults
Official title: The Evaluation of TCI378 and TCI507 Probiotics on Weight-lowering Efficacy in Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Weight Reduction
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-06-02
Enrollment: 96
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Obesity is a serious global public health issue. Many reports have showed that the use of appropriate probiotics can bring benefits to the health of the host and promote the balance of gut microbiota. Clinical experimental data show that the supplement of probiotics can help regulate gut function and weight control, and etc.

TCI378 (Lactobacillus plantarum TCI378) is a probiotic extracted from Korean kimchi, and TCI507 (Lactobacillus plantarum TCI507) is a probiotic extracted from the oranges peels. These two strains of probiotics have been verified by in vitro experiments to have the effect of hydrolyzing bile salts, inhibition of the production of fat cells. Therefore, we want to evaluate whether the probiotics TCI308 and TCI507 have effects on reduction of body weight.


Eligibility criteria: Inclusion Criteria:

1. Adults between the ages of 20 and 65 who are willing to sign the consent form of the subject.
2. For those with BMI ≥ 24, men's body fat ≥ 25%, women's body fat ≥ 30%
3. Those who are not pregnant and are willing to cooperate with contraception during the trial period.
4. Those who have no history of cardiovascular disease, organ transplantation, epilepsy or convulsions, liver and kidney disease, malignant tumors, endocrine disease, mental disease, alcohol or drug abuse, and other major organic diseases (according to medical history).

Exclusion Criteria:

1. Pregnant women, people with a history of cardiovascular disease, organ transplantation, epilepsy or convulsions, liver and kidney disease, malignant tumors, endocrine diseases, mental illness, alcohol or drug abuse, and other major organic diseases (according to medical history).
2. Those who had undergone major surgery or bariatric surgery (according to medical history).
3. Currently or within 3 months before participating in the screening, those subjects used drugs that can affect body fat or increase weight significantly, such as systemic corticosteroids, tricyclic antidepressants, atypical psychiatric drugs, and mood stability Drugs (according to medical history).

Primary outcomes:
measure: To evaluate whether the probiotics TCI378 (Lactobacillus plantarum TCI378) and TCI507 (Lactobacillus plantarum TCI507) have effect on reduction of body weight.
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: