louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05035186: Efficacy of Clarithromycin and Flouroquinolones Based Regimens in H.Pylori Eradication in Covid-19 Era
Official title: Efficacy of Clarithromycin and Flouroquinolones Based Regimens in H.Pylori Eradication in Covid-19 Era: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Helicobacter Pylori Infection
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 233
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Era of COVID-19 and the related panic lead to widely spread antibiotics misuse especially for azithromycin. Cross sensitivity between azithromycin and clarithromycin can impact success rates of H. pylori treatment regimens.(1) Here we aim to explore this point in Egyptian patients.

Sample size Supposing the cure rate of clarithromycin-based regimen to levofloxacin based regimen is 69% versus 84.5% respectively. Using Medcalc, the minimal required sample size is 116 patients for each arm (type 1 error= 5%, type II error=20%). Each arm increased by 10% to compensate for drop-out. The sample size will be 135 for each arm.

Study Arms:

* Arm 1: The first group will receive (amoxicillin 1g/12 hrs, Clarithromycin 500 mg/12hrs, esomeprazole 40mg/12hrs)
* Arm 2: The second group will receive (esomeprazole 40 mg/12hrs, levofloxacin 500 mg/24 hrs, and amoxicillin 1gm/12 hrs).
* To confirm patient compliance, we will ask patients to bring their remaining medication and counted the rest of their pills. Patients with a compliance of \<80% will be excluded from the study per protocol (PP) analysis.


Eligibility criteria: Inclusion Criteria:

* • Patients aged 18-65 years old with newly diagnosed positive H. pylori antigen in stools, urea breath test or H. pylori detected on endoscopy.

Exclusion Criteria:

* • Women who are pregnant or lactating, patients previously treated with H. pylori eradication therapy, those with recent exposure to antibiotics within the previous 3 months, patients who previously underwent gastric surgery, patients with malignant neoplasms, and patients with other severe concomitant diseases like renal, hepatic impairement, heart failure NYHA class II or more, hypoalbuminemia and those with possible clinically significant drug-drug interaction with any of the study's drugs will be excluded.

  * Known allergy to antibiotics.

Primary outcomes:
measure: H. pylori eradication rates
timeFrame: 6 weeks from end of treatment and at least 2 weeks with no administration of PPIs
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University.
Study officials:
affiliation: Alexandria University
name: Ahmed Kamal
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02093286: Safety Profile Following Pentabio Vaccination in Indonesian Infants
Official title: Phase IV, Study of Safety Profile Following Pentabio Vaccination in Indonesian Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Pentabio Vaccine
Safety
Infants
Booster Dose
DTwP/HepB/Hib
Lead sponsor: PT Bio Farma
Sponsor class: INDUSTRY
First posted: 2014-03-20
Enrollment: 4000
Sex: ALL
Minimum age (years): 2
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 4000 infants, 2-11 months old From 4 provincial health primary center

Brief summary: To assess any serious systemic reaction within 30 minutes after Pentabio immunization

Detailed description: Any local and systemic reaction after Pentabio immunization

Eligibility criteria: Inclusion Criteria:

* Immunization with Pentabio vaccine
* Parents already understood the consequences to be involved in this study and having signed the informed consent form
* Parents agree and willing to fill in the Diary Card, to record all the reactions after immunization

Exclusion Criteria:

* Given simultaneously with other vaccines or with the interval less than 1 month with other vaccination except OPV/IPV.

Primary outcomes:
measure: Any serious adverse event occurring from inclusion until 30 minutes after the injection
timeFrame: 30 minutes
Secondary outcomes:
measure: Percentage of local and systemic events occurring within 72 hours after each injection
timeFrame: 72 hours
measure: Percentage of local and systemic events occurring from 72 hours up to 28 days following injection.
timeFrame: 25 days
measure: Percentage of serious adverse events within 28 days after injection
timeFrame: 28 days
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: West Java Provincial Ministry of Health
state: West Java
city: Mataram
country: Indonesia
facility: West Nusa Tenggara Provincial Ministry of Health
state: West Nusa Tenggara
city: Bali
country: Indonesia
facility: Bali Provincial Ministry of Health
city: Yogyakarta
country: Indonesia
facility: Yogyakarta Provincial Ministry of Health
Study officials:
affiliation: AEFI National Committee
name: Julitasari Sundoro, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05691686: Bread Structure and Postprandial Metabolic Responses
Official title: Effects of Less-processed Whole Grain Bread Products (Wheat and Fortified With Legumes) on Postprandial Glucose and Subsequent Metabolic Responses.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postprandial Hyperglycemia
Keywords: bread
food structure
glycemic control
appetite regulation
Lead sponsor: Harokopio University
Sponsor class: OTHER
Collaborators: name: National and Kapodistrian University of Athens
First posted: 2023-01-20
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The structural properties of bread are considered one of the most important factors that can affect its digestibility, glucose homeostasis and postprandial metabolic responses. The purpose of this study is to examine the effects of consumption of less processed whole grain bread products (wheat and fortified with legumes) in comparison with finely milled whole grain bread products on postprandial glycaemic response and appetite regulation.

Detailed description: Postprandial glucose response caused by bread products of different degree of processing, as well as their appetite regulating properties will be evaluated. In the intervention there are totally four samples, the reference (white wheat bread), the less processed whole wheat bread, the whole wheat bread fortified with finely milled legumes (chickpeas), the whole wheat bread fortified with less processed legumes (chickpeas). The volunteers that will be enrolled in the study should be apparently healthy subjects (women and men) with normal body weight. Certain effects related to the structure of the different products on glycemic and insulinemic responses, subjective appetite ratings and other parameters will be examined.

Eligibility criteria: Inclusion Criteria:

* normal exercise and dietary habbits
* weight stable for at least 3 months before enrollment

Exclusion Criteria:

* pregnancy and lactation
* diabetes
* chronic medical illness
* regular intense exercise (\>5 hrs/week)
* alcohol consumption \>2 drinks/day

Primary outcomes:
measure: Change in glucose incremental area under the curve (iAUC) after consumption of the breads compared to the iAUC after consumption of the reference food.
timeFrame: Time points: 0 (before food consumption), 30, 45, 60, 90,120,180 minutes postprandially (4 times in total).
Secondary outcomes:
measure: Subjective appetite ratings
timeFrame: Time points: 0 (before food consumption), 30, 60, 90,120,180 minutes postprandially (4 times in total).
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Amalia Yanni
state: Attiki
Study officials:
affiliation: National and Kapodistrian University of Athens
name: Nikolaos Tentolouris, Professor
role: STUDY_CHAIR
affiliation: Harokopio University of Athens
name: Vaios Karathanos, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT03741686: Effect of Konjac-mannan in Individuals With Insulin-Resistance Syndrome
Official title: Beneficial Effects of Viscous Dietary Fiber From Konjac-Mannan in Subjects With the Insulin Resistance Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Insulin Resistance Syndrome
Keywords: insulin resistance syndrome
fiber
konjac
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: Dicofarm
name: University of Toronto, Toronto
First posted: 2018-11-15
Enrollment: 11
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To study whether a diet high in fiber from Konjac-mannan (KJM) has an effect on metabolic control in individuals with insulin resistance syndrome.


Eligibility criteria: Inclusion Criteria:

* Impaired glucose tolerant
* Clinical absent of CHD
* BMI less than 30 kg/m2
* Presence of full insulin resistance syndrome
* Reduced HDL cholesterol
* Elevated serum triglycerides
* Moderate hypertension

Exclusion Criteria:

* Regular smoking
* Regular alcohol consumption
* Family history of premature coronary heart disease
* Hypothyroidism
* Renal, hepatic or gastrointestinal disease
* Taking medications for hyperglycemia
* Taking medications for hyperlipidemia
* Taking medications for hypertension

Primary outcomes:
measure: change in total:HDL cholesterol
timeFrame: change from baseline after 3 weeks, relative to control
measure: change in fructosamine
timeFrame: change from baseline after 3 weeks, relative to control
measure: change in systolic blood pressure
timeFrame: change from baseline after 3 weeks, relative to control
Secondary outcomes:
measure: change in total cholesterol
timeFrame: change from baseline after 3 weeks, relative to control
measure: change in LDL cholesterol
timeFrame: change from baseline after 3 weeks, relative to control
measure: change in HDL cholesterol
timeFrame: change from baseline after 3 weeks, relative to control
measure: change in apolipoprotein A-1
timeFrame: change from baseline after 3 weeks, relative to control
measure: change in apolipoprotain B
timeFrame: change from baseline after 3 weeks, relative to control
measure: change in glucose
timeFrame: change from baseline after 3 weeks, relative to control
measure: change in insulin
timeFrame: change from baseline after 3 weeks, relative to control
measure: change in diastolic blood pressure
timeFrame: change from baseline after 3 weeks, relative to control
measure: change in body weight
timeFrame: change from baseline after 3 weeks, relative to control
measure: change in apoB:ApoA-1
timeFrame: change from baseline after 3 weeks, relative to control
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02123186: Newborn Screening for Spinal Muscular Atrophy
Official title: Newborn Screening for Spinal Muscular Atrophy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Muscular Atrophy
Keywords: Newborn Screening , spinal muscular atrophy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2014-04-25
Enrollment: 120267
Sex: ALL
Minimum age (years): 2
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: newborns whose parents agree to be tested

Brief summary: To test if the routine newborn screening dried blood spots can be used to test if missing 2 copies of SMN1 gene, a status indicating spinal muscular atrophy

Detailed description: Parents of newborns will be invited to test if their newborns are affected with SMA. The routine newborn screening dried blood spots sample will be used to test if missing 2 copies of SMN1 gene. If positive of screening test, further confirmation tests including physical examination and other methology for SMN1 gene copies quantification will be provided. Genetic counseling and treatment option will be provided, too.

Eligibility criteria: Inclusion Criteria:

* Babies born in Taiwan receive regular new born screening suggested by Ministry of Heath and Welfare.
* Parents or Legal Guardian sign in the informed consent form.

Exclusion Criteria:

* Parents or Legal Guardian do not agree to sign in the informed consent form.

Primary outcomes:
measure: numbers of newborn with spinal muscular atrophy
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
state: Taiwan,
Study officials:
affiliation: National Taiwan University Hospital
name: Yin-Hsiu Chien, M.D., PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chien YH, Chiang SC, Weng WC, Lee NC, Lin CJ, Hsieh WS, Lee WT, Jong YJ, Ko TM, Hwu WL. Presymptomatic Diagnosis of Spinal Muscular Atrophy Through Newborn Screening. J Pediatr. 2017 Nov;190:124-129.e1. doi: 10.1016/j.jpeds.2017.06.042. Epub 2017 Jul 12.
Clinical trial NCT01274286: Evaluation of the Effectiveness of the New Hospital Accreditation
Official title: Evaluation of the Effectiveness of the New Hospital Accreditation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hospital Accreditation
Keywords: hospital accreditation
patient-centered
healthcare quality index
documentary analysis
meta analysis
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2011-01-11
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: PROBABILITY_SAMPLE
Study population: Patients Doctors

Brief summary: Since the first hospital accreditation was implemented in our country in 1978, we have become the fifth in the world, the first in Asia that applied the system of hospital accreditation. While discussing the development of the hospital accreditation history of Taiwan, different concerns have been raised over time.

The main objective of this study is to scrutinize if there have been any quality improvement of healthcare that hospitals delivered since the renewal of hospital accreditation standards. Also, in order to provide suggestions to make the hospital accreditation a better one, this study firstly endeavors to locate the differences which were brought out by both the old and the new hospital accreditation.

Second, this study will analyze and survey the impacts of accreditation on hospitals' performance and healthcare. After finishing the first two steps, this study will then state updated improvement suggestions.

Documentary analysis and meta analysis will be the two major scientific research methods in this study. Data will be collected from various resources, such as government agencies, private research institution and hospitals around the nation. By collecting raw data broadly and deeply, the accountability, therefore, can be ensured.

Throughout the efforts of identifying differences between the new and old accreditation standards, comparing hospitals' scores on performance index and finding evidence of performance improvement, we hope this study would provide the most comprehensive and solid suggestions to improve our hospital accreditation system.


Eligibility criteria: Inclusion Criteria:

* above 20 years old

Exclusion Criteria:

* none

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University
Study officials:
affiliation: Taipei Medical University
name: Che-Ming Yang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02758886: Pet Your Stress Away Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Physiological
Stress, Psychological
Lead sponsor: Washington State University
Sponsor class: OTHER
First posted: 2016-05-03
Enrollment: 247
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether an animal visitation programs on college campuses are effective in the treatment of college student stress reduction during preparation for final examinations.


Eligibility criteria: Inclusion Criteria:

* Undergraduate status

Exclusion Criteria:

* None

Primary outcomes:
measure: Change in physiological stress measured via salivary cortisol
timeFrame: On the day of program participation: Once immediately upon waking up, and immediately before and after participation in the assigned 10 minute intervention
measure: Change in momentary emotion using the experience sampling method questionnaire
timeFrame: Momentary emotion was measured twice, immediately before and after participation in the assigned 10 minute intervention
Secondary outcomes:
measure: Change in physiological stress measured via salivary Alpha-amylase
timeFrame: On the day of program participation: Once immediately upon waking up, and immediately before and after participation in the assigned 10 minute intervention
Other outcomes:
Locations:
Study officials:
affiliation: Washington State University
name: Patricia Pendry, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06463886: Striving Towards EmPowerment and Medication Adherence R01
Official title: A Randomized Control Trial of Striving Towards EmPowerment and Medication Adherence (STEP-AD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hiv
Mental Health Issue
Keywords: HIV
Black women
Trauma
Intersectional
Discrimination
Stigma
Medication adherence
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2024-06-18
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study for Black women living with HIV to test a counseling program for Black women living with HIV. This participant may be a good fit if the participant is a Black woman, living with HIV, has a history of trauma, and is currently taking Antiretroviral Therapy (ART) medicines


Eligibility criteria: Inclusion criteria:

1. Black
2. Living with HIV
3. Cis-gender female
4. Age 18 or older
5. English speaking
6. Viral load non-suppression (\>200 ml) within the past year or a lack of HIV viral load measure for 6 consecutive months or more during the past 12 months
7. History of trauma/abuse
8. Capable of completing and fully understanding the informed consent process and study procedures

Exclusion criteria:

1. Unable to completely and fully understand the informed consent process and the study procedures
2. Significantly interfering mental health symptoms (e.g., active psychosis that is untreated)

Primary outcomes:
measure: Change in viral suppression
timeFrame: Baseline up to 1.5 years
Secondary outcomes:
measure: Change in antiretroviral (ART) adherence
timeFrame: Baseline up to 1.5 years
measure: Change in adherence to anti-retroviral medications questionnaire
timeFrame: Baseline up to 1.5 years
measure: Change in engagement in HIV care
timeFrame: Baseline up to 1.5 years
measure: Change in PTSD as measured by PCL-5
timeFrame: Baseline up to 1.5 years
measure: Change in Post-traumatic cognitions measured by PTCI
timeFrame: Baseline up to 1.5 years
measure: Change in Post-traumatic Stress Disorder Diagnosis
timeFrame: Baseline up to 1.5 years
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Sannisha Dale, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02475486: Role of the ANS Dysregulation in the Persistence of Fatigue in Rheumatoid Arthritis Patients Treated With Anti-TNF
Official title: Role of the Sympathetic Nervous System (ANS) Dysregulation in the Persistence of Fatigue in Rheumatoid Arthritis Patients Treated With Anti-TNF (Tumor Necrosis Factor) - a Monocentric Cross-sectional Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
sympathetic nervous system
SNA
fatigue
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2015-06-18
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Despite the large therapeutic arsenal available since one decade allowing a strong reduction of inflammation process, rheumatoid arthritis (RA) patients claimed pain, fatigue, sleep problems and other quality of life outcomes. Fatigue reduction during TNF blockers therapy is lower than the strong reduction in RA disease activity. Furthermore, RA patients have higher prevalence of non-inflammatory pain than general population. Fatigue is a real major problem due to 50% of patients considered it as severe.

This dissociation between disease activity and fatigue level suggests that fatigue is multifactorial. No consistent explanations for fatigue are currently available.


Eligibility criteria: Inclusion Criteria :

* RA diagnosis according to ACR/EULAR 2010
* RA with low disease activity according to DAS28 \< 3.2
* Written consent obtained

Exclusion Criteria :

* Other diagnosis than RA
* Depression known
* Hypertension treated or not,
* Diseases interfering with ANS analysis: cardiac arrhythmia, beta-blocker therapy,
* Pregnant or breastfeeding women,
* Inability to go two consecutive days at the North hospital for the delivery and return of the Vista02 device

Primary outcomes:
measure: Ratio low/high frequencies of power spectral density of R-R intervals
timeFrame: day1
Secondary outcomes:
measure: Number of sleep apnea syndrome
timeFrame: day 1
measure: Standard deviation of all R-R intervals (SDNN)
timeFrame: day 1
measure: Total Power spectral density (PSD)
timeFrame: day 1
measure: PSD of Lower Frequencies
timeFrame: day 1
measure: PSD of High Frequencies
timeFrame: day 1
measure: normalized value of the High and Low frequencies
timeFrame: day 1
measure: Physical activity
timeFrame: day 1
measure: quality of sleep
timeFrame: day 1
measure: depression
timeFrame: day 1
measure: Correlation between fatigue and Ratio low/high frequencies of power spectral density of R-R intervals
timeFrame: day 1
Other outcomes:
Locations:
city: Saint-etienne
country: France
facility: Chu Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Hubert Marotte, PUPH
role: PRINCIPAL_INVESTIGATOR
References: