louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02262091: Immune Benefits of WGP in Elderly
Official title: Strengthening Immunity of Prefrail and Frail Elderly by WGP
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly People
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2014-10-10
Enrollment: 150
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this research is to assess the immune enhancing property of food fibers in the elderly population.


Eligibility criteria: Inclusion Criteria:

* Male and female elderly volunteers equal or above age of 70
* Pre-frail and frail subjects (based on Fried's criteria)
* Willing to be vaccinated against influenza and having no contraindication to receive influenza vaccination
* Having obtained his/her (or his/her legal representative's) informed consent

Exclusion Criteria:

* Subject with a rapidly deteriorating health status (terminal, severe, or uncontrolled acute/chronic diseases)
* Allergy to eggs or influenza vaccine components.
* Subject who has received any vaccination in the last 3 months or has previously been vaccinated with the current seasonal influenza vaccine.
* Subject who is currently taking, or has taken in the last 4 weeks, or will take immune modulating medication during the study, including steroid, immune suppressive treatment.
* Subject who has taken antibiotics in the last 2 months prior to entering the study.
* Subject who is consuming regularly prebiotic and/or probiotic supplements, yogurts, and/or other dietary supplements.
* Personal or family history of Guillain-Barre syndrome
* BMI\>35 kg/m2
* Subject who has received blood transfusion or had a blood donation during the last 4 weeks prior to the beginning of this study.
* Subject who cannot be expected to comply with the study procedures
* Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study

Primary outcomes:
measure: Change from baseline at 4 weeks post-vaccination in antibody titers levels
timeFrame: Up to 1 month
Secondary outcomes:
measure: Measure of seroconversion
timeFrame: Up to 2 months
measure: Measure of cytokines production
timeFrame: Up to 2 months 2014
measure: Measure the occurence of clinical endpoints
timeFrame: Up to 2 months
measure: Measure of seroprotection
timeFrame: Up to 2 months
Other outcomes:
Locations:
city: Oldenburg
country: Germany
facility: Leiter des Geriatrischen Zentrums Oldenburg (GZO)
Study officials:
References:
citation: Bauer JM, De Castro A, Bosco N, Romagny C, Diekmann R, Benyacoub J, Vidal K. Influenza vaccine response in community-dwelling German prefrail and frail individuals. Immun Ageing. 2017 Jul 6;14:17. doi: 10.1186/s12979-017-0098-z. eCollection 2017.
Clinical trial NCT06351891: Efficacy and Safety of Bismuth Quadruple Therapy Containing Cefuroxime and Tetracycline as First-line Therapy for Eradicating Helicobacter Pylori in Patients Allergic to Penicillin
Official title: Efficacy and Safety of Bismuth Quadruple Therapy Containing Cefuroxime and Tetracycline as First-line Therapy for Eradicating Helicobacter Pylori in Patients Allergic to Penicillin: A Multicenter, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter Pylori Infection
Bismuth-containing quadruple therapy
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2024-04-08
Enrollment: 248
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: The researchers collected untreated H. pylori positive patients from outpatient clinics. Subjects were randomly assigned to receive either 14 days of bismuth quadruple therapy with cefuroxime and tetracycline or 14 days of bismuth quadruple therapy with cefuroxime and levofloxacin for Helicobacter pylori eradication. After 6 weeks of treatment, subjects underwent another 13C urea breath test. Eradication rates, adverse reaction rates and patient compliance were calculated.


Eligibility criteria: Inclusion Criteria:

1. Age 18-70 years old, regardless of gender.
2. History of penicillin allergy.
3. Helicobacter pylori infection.
4. Patients who have not previously received Helicobacter pylori eradication therapy.

Exclusion Criteria:

1. Medication history of bismuth and antibiotics within 4 weeks; PPIs and P-CABs within 2 weeks.
2. Serious underlying diseases, such as liver insufficiency, renal insufficiency, malignant tumors, etc.
3. Previous gastric or esophageal surgery.
4. History of allergy to test drugs.
5. Pregnant and lactating women and those unwilling to use contraception during the trial period.
6. Have other behaviors that may increase the risk such as alcohol and drug abuse.
7. Those unable to provide informed consent.

Primary outcomes:
measure: Eradication rate
timeFrame: immediately after the procedure
Secondary outcomes:
measure: Rate of adverse reactions
timeFrame: immediately after the procedure
measure: Patient compliance
timeFrame: immediately after the procedure
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Yueyue Li, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04815291: Streamlined Localization Using SCOUT® at Biopsy (STREAMLoc )
Official title: STREAMLoc- Streamlined Localization Using SCOUT® at Biopsy: An Analysis of Process Improvement, Cost Savings and Enhanced Patient Experience.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Merit Medical Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-25
Enrollment: 93
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This registry is intended to demonstrate the utility of SCOUT® in the Canadian public and US healthcare systems with fixed resources and a conservative approach to patient and clinician exposure to harm. The efficacy and safety of this system will be further assessed, as well as the acceptance of clinicians and patients.

Detailed description: This registry is intended to demonstrate the utility of SCOUT® in the Canadian public and US healthcare systems with fixed resources and a conservative approach to patient and clinician exposure to harm (i.e., radiation, COVID-19 exposure, patient emotional trauma). By assessing the utility of reflector insertion at the time of biopsy, this study will be able to measure the impact on patient visits to the breast center for invasive procedures between biopsy and surgery, and quantify this value to the public healthcare system. The efficacy and safety of this system will be further assessed, as well as the acceptance of clinicians and patients.

Eligibility criteria: Inclusion Criteria:

1. Woman \>18 years and \< 80 years of age;
2. Classified as Breast Imaging Reporting and Data System (BI-RADS) 4C or 5;
3. Lesion depth is \< 6 cm from skin surface;
4. Non-palpable lesions;
5. Informed consent obtained.

Exclusion Criteria:

1. Multicentric breast cancer;
2. Pregnant or lactating;
3. Known or suspected nickel-titanium allergy.

Primary outcomes:
measure: Number of Participants Invasive Visits
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: through study completion; an average of 6 months
measure: Performance
timeFrame: through study completion; an average of 6 months
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal (CHUM)
state: Quebec
city: Quebec
country: Canada
facility: St. Sacrement
Study officials:
affiliation: St. Sacrement
name: C Desbiens, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05658991: Electrophysiological Changes With Diet.
Official title: Retinal Functional Changes With Different Dietary Habits.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fasting, Intermittent
Fasting Hypoglycemia
Fasting
Obesity
Diabetes
Keywords: Fasting
Ramadan
Diet
Retina
Electroretinogram
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2022-12-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Dietary habits may affect our body by certain mechanisms, visual sense is one of the most vital human senses that needs special attention in our daily habits.

Detailed description: Retinal function directly related to our quality of vision, different drugs can affect our vision in certain ways, however, out unhealthy dietary habits can indirectly affect our quality of life and vision.

Eligibility criteria: Inclusion Criteria:

* healthy subjects with intermittent fasting.
* obese subjects with body mass index more than 30.

Exclusion Criteria:

* patients with any retinal diseases that may ter retinal functional test.
* patients on systemic drugs that may alter retinal function.

Primary outcomes:
measure: Retinal function amplitude
timeFrame: Baseline and one month after fasting in both groups.
Secondary outcomes:
measure: Retinal function latency.
timeFrame: Baseline and one month after fasting in both groups.
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Ahmed Abdelshafy Tabl
state: Benha
Study officials:
affiliation: Benha University
name: Ahmed A Tabl, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03131791: Comparing the Radial Extracorporeal Shock Waves and Botulinum Toxin Injection for Spasticity
Official title: Radial Extracorporeal Shock Wave Versus Botulinum Toxin A in the Treatment of Post-Stroke Upper Limb Spasticity: A Randomized Non-Inferiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Stroke Upper Limb Spasticity
Keywords: Extracorporeal Shock Wave
Spasticity in stokes
Botulinum toxin
Lead sponsor: Mackay Memorial Hospital
Sponsor class: OTHER
First posted: 2017-04-27
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: group A : shock wave, group B: Botulinum Toxin Injection
Primary purpose: TREATMENT

Brief summary: Botulinum toxin type A (BoNT-A) is widely used in the clinics to reduce spasticity and improve upper limb function for post-stroke patients. However, there were no studies to compare the effect of rESWT and BoNT-A injection for treatment on spasticity.

Detailed description: Botulinum toxin type A (BoNT-A) is widely used in the clinics to reduce spasticity and improve upper limb function for post-stroke patients. However, the treatments of BoNT-A injection are associated with high cost and invasive treatment. Recent studies have showed that radial extracorporeal shock wave (rESWT) is a novel, effective and safety treatment method for the spasticity. However, there were no studies to compare the effect of rESWT and BoNT-A injection for treatment on spasticity.

Eligibility criteria: Inclusion Criteria:

1. Aged between 18-80 year-old
2. The onset of stroke must be at least 6 months previously
3. Spasticity measured as Modified Asthow Scale more(MAS) than 1+
4. Signed informed consent form

Exclusion Criteria:

1. Patients with marked contractures in the elbow and wrist (MAS\>4)
2. Resistant hypertension, coagulation disorders, malignant tumors, pregnancy, pacemakers, cognitive disorders
3. Prior or planned treatment with phenol or alcohol nerve blocks, intrathecal baclofen, or BoNT-A injection within the six months preceding the study

Primary outcomes:
measure: The change of spasticity of elbow
timeFrame: Between baseline and 4 weeks post-treatment
Secondary outcomes:
measure: The change of Tardieu scale scores for the elbow and wrist
timeFrame: Between baseline and 1, 4,8 weeks post-treatment
measure: The change of upper limb function
timeFrame: Between baseline and 1,4,8 weeks post-treatment
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
Study officials:
References:
citation: Wu YT, Yu HK, Chen LR, Chang CN, Chen YM, Hu GC. Extracorporeal Shock Waves Versus Botulinum Toxin Type A in the Treatment of Poststroke Upper Limb Spasticity: A Randomized Noninferiority Trial. Arch Phys Med Rehabil. 2018 Nov;99(11):2143-2150. doi: 10.1016/j.apmr.2018.05.035. Epub 2018 Jul 4.
Clinical trial NCT02421991: Telephone-Delivered Interventions for Smoking Cessation
Official title: Telephone-Delivered Interventions for Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: Consumer Wellness Solutions
name: National Institute on Drug Abuse (NIDA)
name: National Cancer Institute (NCI)
First posted: 2015-04-21
Enrollment: 1275
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate that Acceptance and Commitment Therapy's (ACT) implementation outcomes are at least as good as those of traditional cognitive behavioral therapy (CBT).


Eligibility criteria: Inclusion Criteria:

1. ages 18 and older
2. smokes at least ten cigarettes per day (to be eligible for NRT) and has done so for at least the past 12 months
3. wants to quit smoking in the next 30 days
4. if concurrently using any other nicotine or tobacco products wants to quit using them within the next 30 days
5. willing to be randomly assigned to either group
6. willing and able to speak and read in English
7. willing and medically eligible to use NRT
8. resides in the U.S., and expects to continue for at least 12 months
9. not participating in other smoking cessation interventions (including our own intervention trials)
10. has regular access to a telephone.

Exclusion Criteria:

The exclusion criteria are opposite of the inclusion criteria listed above.

In addition we will exclude:

1. anyone who is pregnant or breast feeding
2. has had a heart attack in the past 30 days
3. has unstable angina
4. has evidence of arrhythmia in the past 6 months
5. has a history of severe skin reaction to adhesive patches.

Primary outcomes:
measure: 30 day point prevalence abstinence
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: Jonathan B Bricker, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jackson S, Brown J, Norris E, Livingstone-Banks J, Hayes E, Lindson N. Mindfulness for smoking cessation. Cochrane Database Syst Rev. 2022 Apr 14;4(4):CD013696. doi: 10.1002/14651858.CD013696.pub2.
Clinical trial NCT02693691: CardioMEMS European Monitoring Study for Heart Failure
Official title: CardioMEMS European Monitoring Study for Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2016-02-29
Enrollment: 239
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 purpose of this study is to characterize the use of the CardioMEMS™ HF System when used in a real-world setting.


Eligibility criteria: Inclusion Criteria:

* Indicated to receive a CardioMEMS sensor implant per the CardioMEMS™ HF System User's Manual
* ≥ 18 years of age
* Diagnosis of New York Heart Association (NYHA) Class III Heart Failure at the time of sensor implantation
* Hospitalization for worsening HF, as defined in the protocol, within 12 months prior to the CardioMEMS HF System implant
* Subjects with reduced Left Ventricular Ejection Fraction (LVEF) must be on stable Guideline Directed Medical Therapy (GDMT) as tolerated
* Written informed consent obtained from subject

Exclusion Criteria:

* Known coagulation disorders or inability to take two types of blood thinning medications for one month after the sensor is implanted
* Subjects deemed a candidate for transplant, Ventricular Assist Device, or hospice care in the next 12 months or are otherwise not expected to be able to complete the study follow up

Primary outcomes:
measure: Freedom From Device/System Related Complications
timeFrame: one year
measure: Freedom From Pressure Sensor Failure
timeFrame: one year
measure: Percent of Successful Pulmonary Artery Pressure Data Transmissions
timeFrame: one year
Secondary outcomes:
measure: Heart Failure Hospitalization (HFH) Rate
timeFrame: one year
Other outcomes:
Locations:
city: Coburg
country: Germany
facility: Klinukum Coburg
state: Bavaria
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
state: Bavaria
Study officials:
affiliation: Deutsches Zentrum für Herzinsuffizienz Würzburg
name: Christiane Angermann, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Saarland
name: Michael Boehm, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bohm M, Assmus B, Anker SD, Asselbergs FW, Brachmann J, Brett ME, Brugts JJ, Ertl G, Wang A, Hilker L, Koehler F, Rosenkranz S, Leistner DM, Abdin A, Wintrich J, Zhou Q, Adamson PB, Angermann CE. Less loop diuretic use in patients on sacubitril/valsartan undergoing remote pulmonary artery pressure monitoring. ESC Heart Fail. 2022 Feb;9(1):155-163. doi: 10.1002/ehf2.13665. Epub 2021 Nov 4.
citation: Angermann CE, Assmus B, Anker SD, Brachmann J, Ertl G, Kohler F, Rosenkranz S, Tschope C, Adamson PB, Bohm M. Safety and feasibility of pulmonary artery pressure-guided heart failure therapy: rationale and design of the prospective CardioMEMS Monitoring Study for Heart Failure (MEMS-HF). Clin Res Cardiol. 2018 Nov;107(11):991-1002. doi: 10.1007/s00392-018-1281-8. Epub 2018 May 19.
Clinical trial NCT00969891: Study of Dosage Individualisation for the Treatment of Acute Myeloid Leukemia
Official title: Population Based Pharmacokinetic and Pharmacodynamic Dosage Model for Cytarabine, Daunorubicin and Etoposide for Acute Myeloid Leukemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myeloid Leukemia
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
name: Herlev Hospital
First posted: 2009-09-01
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients with acute myeloid leukemia

Brief summary: The present study is not hypothesis driven but will explore the ability of pharmacokinetic-pharmacodynamic modelling to predict optimal dosage of the chemotherapeutic drugs used in therapy in adult patients with acute myeloid leukemia.


Eligibility criteria: Inclusion Criteria:

* adult men and women with newly diagnosed acute myeloid leukemia

Exclusion Criteria:

* under age 18 years

Primary outcomes:
measure: significant covariates from the PK study
timeFrame: after complete analysis of data
Secondary outcomes:
measure: Amount of the three drugs in patient plasma samples
timeFrame: within 3 months of sampling
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet, Hematology clinic
city: Herlev
country: Denmark
facility: Herlev Hospital, Hematology Clinic
Study officials:
affiliation: Rigshospitalet, Denmark
name: Ove J Nielsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03536091: Magnification Endoscopy and Electronic Chromoendoscopy in Patients With Inflammatory Bowel Disease
Official title: Magnification Endoscopy and Electronic Chromoendoscopy in Patients With Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Diseases
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2018-05-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: IBD patients treated in the outpatient department of the University Hospital Erlangen

Brief summary: In this study the investigators aim to evaluate the ability of i-scan OE together with magnification endoscopy to detect and assess microscopic inflammation in patients with inflammator bowel diseases (IBD).

Detailed description: In this study the investigators aim to evaluate the ability of i-scan OE together with magnification endoscopy to detect and assess microscopic inflammation in patients with inflammator bowel diseases. For this purpose, IBD patients will be prospectively enrolled and inflammatory changes will be assessed using optical magnification endoscopy in conjunction with optical chromoendoscopy. Endoscopic scoring of inflammatory changes in IBD patients will be done on a newly developed magnification score resulting as a consensus from experts in optical diagnosis and endoscopy in IBD patients. Results will be correlated against histopathology.

Eligibility criteria: Inclusion Criteria:

* Patients with established diagnosis of Inflammatory Bowel Diseases
* Ability to provide written informed consent
* Age 18 years and older

Exclusion Criteria:

* poor bowel preparation
* inability to provide written informed consent
* minors

Primary outcomes:
measure: Assessment of endoscopic Inflammation
timeFrame: 12 months
measure: Assessment of histopathological Inflammation
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: University Hospital Erlangen
Study officials:
References: