louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04626193: LOAD VS Levofloxacine Concomitant
Official title: Comparing the Efficacy of Two Weeks Therapy of Doxycycline,Levofloxacin,Tinidazole Versus Levofloxacin With Tinidazole on Rate of Eradication of Helicobacter Pylori Infected Patients on Syrian Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Keywords: Doxycycline
LOAD regimen
Helicobacter Pylori
levofloxacine
tinadizole
Lead sponsor: Damascus Hospital
Sponsor class: OTHER
First posted: 2020-11-12
Enrollment: 80
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: Comparison Efficacy of two weeks Therapy with Doxycycline,levofloxacine,Tinadizole Versus Levofloxacine,Tinadizole,Amocillin on Eradication of Helicobacter Pylori in Syrian population.


Eligibility criteria: Inclusion Criteria:

* Patients are aged greater than 18 years old who have H. pylori infection diagnosed by any of following three methods:
* Positive rapid urease test (CLOtest).
* Histologic evidence of H. pylori by modified Giemsa staining.
* Positive 13C-urea breath test. without prior eradication therapy and are willing to receive therapy.

Exclusion Criteria:

* Children and teenagers aged less than 18 years.
* Previous eradication treatment for H. pylori.
* Patients who took any drug, which could influence the study results such as proton pump inhibitor, H2 blocker, mucosal protective agent and antibiotics.
* History of gastrectomy.
* Gastric malignancy, including adenocarcinoma and lymphoma,
* Previous allergic reaction to antibiotics (Amoxicillin, Tinadizole,
* Doxycycline,Bismuth subsalicylate,) and prompt pump inhibitors (Es- omeprazole).
* Contraindication to treatment drugs.
* Pregnant or lactating women.
* Severe concurrent disease.
* Liver cirrhosis.

Primary outcomes:
measure: Eradication rate of Helicobacter pylori infection
timeFrame: 8 week from begning of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: General Assembly of Damascus Hospital
Study officials:
affiliation: general assambly of damascus hospital
name: Marouf M Alhalabi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04515693: Exploring Psychometric Properties of a New Version of the 6MWT in the Acute Stroke Population
Official title: Exploring Psychometric Properties of a New Version of the 6MWT in the Acute Stroke Population
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Stroke
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-08-17
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to assess inter- and intra-rater reliability of the 6MWT in people with acute stroke who require various levels of assistance with walking.


Eligibility criteria: Inclusion Criteria:

* At least 18 years old
* Primary diagnosis of an acute or hemorrhagic stroke
* Admitted into the acute or acute rehab setting and is appropriate for physical therapy services.
* Can ambulate with 1 person assistance and a device as needed, with no more than maximal assistance required. The patient must be able to independently advance the lower extremity forward, but can receive maximal assistance for blocking, bracing or postural control during ambulation.
* Can stand and/or ambulate for at least 6 minutes

Exclusion Criteria:

* Hemodynamically unstable
* Unstable medical co-morbidities such as: active bleeding, recurring seizures, uncontrolled hypertension (permissive HTN orders ok)
* Patients with bilateral acute stroke
* Patients who are unable to follow 1 step commands as determined by the screening physiatrist
* Orthopedic co-morbidities that place a weight-bearing restriction on the lower extremities such as acute fracture, joint replacement, or other musculoskeletal injury
* Any other condition that would limit a patient's ability to remain in a standing position with assistance for 6 minutes at a time.

Primary outcomes:
measure: 6 Minute walk test
timeFrame: 8 minutes (2 minutes for set-up, 6 minutes to execute)
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Hannah Karstetter, PT, DPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02122393: A Randomised Trial of Sertraline, Cognitive Behaviour Therapy & Combined Therapy for Postnatal Depression
Official title: A Randomised, Controlled Evaluation of Sertraline, Cognitive Behaviour Therapy & Combined Therapy for Postnatal Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depression
Anxiety
Lead sponsor: University of Melbourne
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2014-04-24
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Th purpose of this study is to determine whether dual psychological and pharmacological treatment is superior to either mono-therapy alone in the treatment of postnatal depression.


Eligibility criteria: Inclusion Criteria:

* Women with an infant \> 2 months and \< 8 months of age
* Infant born after a full-term pregnancy
* Infant born with no congenital abnormalities
* Diagnosis of depression with postnatal onset according to the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV).

Exclusion Criteria:

* positive serum pregnancy test;
* concurrent psychiatric disorder (excepting co-morbid anxiety);
* recent history of antidepressant usage (within the last month);
* history of major allergy or drug allergy;
* history of substance abuse;
* prior non-response to sertraline, or prior non-response to adequate trials of two selective serotonin reuptake inhibitors (SSRIs);
* predisposition to headache, migraine or nausea;
* tobacco habit in excess of 10 cigarettes per day;
* caffeine consumption in excess of 6 cups of coffee/tea or cola-flavoured drinks per day;
* ongoing dental work;
* extreme levels of depression (psychotic);
* suicidal intent;
* participation in any medical trial within the previous three months;

Primary outcomes:
measure: Beck Depression Inventory
timeFrame: 24 weeks
Secondary outcomes:
measure: Beck Anxiety Inventory
timeFrame: 24 weeks
measure: Parenting Stress Index
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Austin Health
state: Victoria
Study officials:
affiliation: University of Melbourne
name: Jeannette Milgrom, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Austin Health
name: Alan W Gemmill, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04416893: Part 2 on the Study Prevalence of SARS -Cov2 Carriage in Asymptomatic and Mildly-symptomatic Children (COVILLE2) (WHO)
Official title: Prevalence of SARS -Cov2 Carriage in Asymptomatic and Mildly-symptomatic Children, a Cross-sectional, Prospective, Multicentre, Observational Study in Primary Care-Part 2 After the Lifting of the Lockdown
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: COVID19
Keywords: RT-PCR SARS-CoV-2
Serology SARS-CoV-2
Children
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
Collaborators: name: Association Clinique Thérapeutique Infantile du val de Marne
name: Groupe de Pathologies Infectieuses Pédiatriques (GPIP)
name: Francophone Pediatric Resuscitation and Emergency Group (GFRUP)
First posted: 2020-06-04
Enrollment: 0
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children under 15 years of age in a community (kindergarten, school, college, holiday centre, etc.).

Brief summary: France and in particular the paris area was one of the countries most affected by the pandemic Covid19.

School closures and a generalized lockdown of the population were instituted in France from 17 March 2020 to 10 May 2020. Schools and nurseries have reopened partially since 11 May 2020. From 2 June, this reopening is more widespread. By combining the search for SARS-Cov2 viruses by PCR and micro-method serology we will be able to evaluate both the infection at a given time and also older contact with SARS-CoV2.

The temporal knowledge of the prevalence of SARS-Cov2 carriage and the serological status (IgM and IgG) after return to the community are crucial information to evaluate the speed of spread of the virus in children. This is the objective of COVILLE2, phase 2 of the COVILLE study.


Eligibility criteria: Inclusion Criteria:

* Birth to 15 years old
* taking over the community (kindergarten, school, college, holiday centre, etc.) for at least 1 week

Exclusion Criteria:

* refusal to participate

Primary outcomes:
measure: Proportion of asymptomatic children or children with mild respiratory symptoms
timeFrame: At inclusion
Secondary outcomes:
measure: Cov2-SARS cases by age
timeFrame: At inclusion
measure: Cov2-SARS cases by symptoms
timeFrame: At inclusion
measure: Viral load
timeFrame: At inclusion
measure: Presence of anti-SARS-CoV-2 antibodies (IgM and IgG) by the rapid serological test
timeFrame: At inclusion
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03149393: Clinical Study on Post Evaluation After Listing of Qizhi Weitong Granules
Official title: Clinical Study on Post Evaluation After Listing of Qizhi Weitong Granules
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Functional Dyspepsia
Traditional Chinese Medicine
Keywords: Functional Dyspepsia
Qizhi Weitong Granules
Traditional Chinese Medicine
Lead sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2017-05-11
Enrollment: 384
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: This study is a randomized, double blind, double dummy, multicenter, parallel controlled clinical trial, the investigators objective is to evaluate the efficacy and safety of Qizhi Weitong granules in the treatment of functional dyspepsia.

Detailed description: This study is a randomized, double blind, double dummy, multicenter, parallel controlled clinical trial, the investigators objective is to evaluate the efficacy and safety of Qizhi Weitong granules in the treatment of functional dyspepsia. The experiment will be carried out in 8 sub centers at the same time, and the investigators estimated that there will be 384 cases of income, including the experimental group and the control group (n = 192), and the investigators choose mosapride citrate tablets for drug control.

Eligibility criteria: Inclusion Criteria:

1. Metting the diagnostic criteria of functional dyspepsia in Rome IV.
2. The subjects were informed, and the subjects voluntarily signed informed consent.
3. The subjects have reading ability.

Exclusion Criteria:

1. Patients suffering from gastric ulcer, gastroscopy see bleeding and mucosal erosion, pathological examination showed atrophy of gastric mucosa, intestinal metaplasia or dysplasia.
2. Patients with Hp infection positive.
3. Patients with gastroesophageal reflux disease.
4. Patients with digestive system organic lesions.
5. The patient had a history of stomach or abdominal surgery.
6. Patients had taken the relevant drugs in the past 2 weeks.
7. Patients suffering from severe illness affecting survival.
8. Pregnant or lactating women.
9. Participating in clinical trials of other drugs.
10. Long term using of sedative hypnotics.
11. Suspected or true alcohol, drug abuse history.

Primary outcomes:
measure: Change of Main Symptom Score
timeFrame: The score will be assessed at baseline and 2 week, 4 week, 6 week.
Secondary outcomes:
measure: Change of the Hamilton Anxiety Scale and the Hamilton Depression Scale
timeFrame: The score will be assessed at baseline and 2 week, 4 week, 6 week.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xiyuan Hospital, China Academy of Chinese Medical Sciences
state: Beijing
Study officials:
affiliation: Director of Xiyuan Hospital
name: Tang X dong, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01422993: Pilot Study of Strength and Balance Training Program for Persons With Oxaliplatin Induced Neuropathy
Official title: A Pilot Study of a Strength and Balance Training Program for Persons With Oxaliplatin Induced Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuropathy
Gastrointestinal Cancer
Keywords: Oxaliplatin Induced
Peripheral Neuropathy
Strength
Balance
Training Program
Colon
Rectal
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: ONS Foundation
First posted: 2011-08-25
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the effects on strength, balance, and neuropathic symptoms (numbness, tingling, pain, weakness) of a 12 week, bi-weekly, 60 minute, group exercise program designed to improve lower extremity strength and balance with persons with oxaliplatin induced peripheral neuropathy.


Eligibility criteria: Inclusion Criteria:

* Prior history of colon cancer
* Completed oxaliplatin based chemotherapy at least 6 months prior to enrollment
* Report numbness, tingling, or pain of the lower extremities ≥ 4 by chemotherapy induced peripheral neuropathy (CIPN) Visual Analog Rating
* Karnofsky performance status of at least 60%
* Able to read, write, and understand English

Exclusion Criteria:

* Patients will be excluded from the study if they live outside of a 30 mile radius of the University of South Florida, if they are currently undergoing chemotherapy or radiation therapy, or if they regularly (at least once a week) participate in strength or balance training exercises. The investigators will not exclude participants if they are participating in aerobic exercise, but we will collect that information so that the investigators may control for aerobic exercise in our data analysis.

Primary outcomes:
measure: Number of Screened Patients Who Participate and Complete the Study
timeFrame: 10 Months
Secondary outcomes:
measure: Number of Participants Who Experience Side Effects
timeFrame: 10 Months
measure: Number of Participants With Measured Improvement
timeFrame: 10 Months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: University of South Florida
name: Cindy Tofthagen, Ph.D., ARNP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01377493: Effects of a Chewing Gum Containing POs-Ca and Fluoride on Enamel
Official title: Effects of a Chewing Gum Containing POs-Ca and Fluoride on Remineralization of Enamel Subsurface Lesions in Situ
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Enamel Subsurface Lesion
Keywords: chewing-gum
enamel subsurface lesion
calcium additives
fluoride
in situ
Lead sponsor: Tokyo Medical and Dental University
Sponsor class: OTHER
First posted: 2011-06-21
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 31
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: There were no differences in the degree of enamel remineralization of subsurface lesions among the chewing gums containing or not containing POs-Ca and fluoride.


Eligibility criteria: Inclusion Criteria:

* healthy adult subjects
* More than 22 permanent teeth

Exclusion Criteria:

* Alcohol addiction
* Smoking
* Active caries
* Periodontal pockets
* Low-saliva flow (less than 0.3ml/min)

Primary outcomes:
measure: Mineral content of enamel
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Kitasako Y, Sadr A, Hamba H, Ikeda M, Tagami J. Gum containing calcium fluoride reinforces enamel subsurface lesions in situ. J Dent Res. 2012 Apr;91(4):370-5. doi: 10.1177/0022034512439716. Epub 2012 Feb 15.
citation: Kitasako Y, Tanaka M, Sadr A, Hamba H, Ikeda M, Tagami J. Effects of a chewing gum containing phosphoryl oligosaccharides of calcium (POs-Ca) and fluoride on remineralization and crystallization of enamel subsurface lesions in situ. J Dent. 2011 Nov;39(11):771-9. doi: 10.1016/j.jdent.2011.08.009. Epub 2011 Aug 19.
Clinical trial NCT03848793: A Phase 2 Study to Evaluate the Efficacy and Safety of HS-20004 in Type 2 Diabetes Subjects.
Official title: A Phase 2, Multiple Centers, Double-blind, Placebo-Controlled, Randomised Study to Evaluate the Efficacy and Safety of HS-20004 in Type 2 Diabetes Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-02-21
Enrollment: 128
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 study is being conducted to evaluate the efficacy and safety of Noiiglutide Injection as mono-therapy with different doses in subjects with type 2 diabetes compared to placebo for 16 weeks.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes diagnosed for more than 3 months
* HbA1c between 7.5 and 11.0 % (inclusive), and FPG ≥9.0mmol/l
* Body Mass Index (BMI) between 23 and 35 kg/m2(inclusive)

Exclusion Criteria：

* History or family history of drug allergy
* Subjects treated with any other anti-diabetes drug within 8 weeks before screening
* Participation in any other clinical trial of an investigational medicinal product within 3 months before screening
* Smoker or alcohol abuse
* Currently use or plan to use systemic corticosteroid
* History of recurrent severe hypoglycemia
* Type 1 diabetes or secondary diabetes mellitus
* Uncontrolled active or untreated hypertension
* History of pancreatitis (acute or chronic)
* Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary Thyroid Carcinoma (MTC)
* Serious unconscious hypoglycemia history
* Within the past 6 months before screening any of the following: coronary artery revascularization, patients presently classified as being in New York Heart Association (NYHA) Class III or IV, myocardial infarction, stroke or unstable angina and/or persistent and clinically significant arrhythmias
* Female subject of childbearing potential who does not use an acceptable method of birth control, is pregnant or planning a pregnancy, or breastfeeding, or male subject who does not use an acceptable method of birth control
* Subject was not used for the study as determined by the Investigator

Primary outcomes:
measure: HbA1c
timeFrame: 16 weeks treatment
Secondary outcomes:
measure: Change in Fasting Plasma Glucose
timeFrame: 16 weeks treatment
measure: Change in Body Weight
timeFrame: 16 weeks treatment
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Drum Tower hospital The Affiliated Hospital of Nanjing University Medical School
state: Jiangsu
Study officials:
References:
Clinical trial NCT03111693: CT Evaluation of Cardiovascular Risk Markers in Obese Patients
Official title: CT Evaluation of Cardiovascular Risk Markers in Obese Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epicardial Fat
Obesity
Cardiovascular Risks Markers
Metabolic Syndrome
Low Dose Computed Tomography
Keywords: Epicardial fat
Obesity
Cardiovascular risks markers
Metabolic syndrome
Low dose computed tomography
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2017-04-13
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: obese population

Brief summary: Obesity is a chronic metabolic disorder : it leads to coronary heart disease and early atherosclerosis.

Coronary artery calcium measured by CT is known as a robust predictor to predict risk for cardiac events in symptomatic and asymptomatic individuals. Furthermore, recent studies show that other CT risk factor exists, independent of calcium scoring, such as epicardial fat, intrathoracic fat and visceral fat.

The aim of this prospective study is to evaluate these new cardiovascular risk markers in obese patients, using standard dose CT and low dose CT with adaptative statistical iterative reconstruction.

Detailed description: In this prospective single-center study, obese patients of our clinical nutrition service, hospitalized for nutritional assessement, are included.

All unenhanced coroCT examinations are performed on the same 64-Row CT scanner (discovery CT 750 HD scanner, GE Healthcare), using prospective ECG-triggerring. The investigation protocol began with a standard-dose acquisition followed immediately by a low-dose acquisition, recorded over strictly identical segments (identical first and last sections).

After these two examinations, estimated dose values are less than the diagnostic scan reference level for a coroCT.

Eligibility criteria: Inclusion Criteria:

* obesity \>30 indicated non enhanced coroCT for calcium scoring.

Exclusion Criteria:

* \<18 ans
* low Framingham scoring
* pregnancy
* not providing informed consent
* history of cardiovascular disease.

Primary outcomes:
measure: Epicardial fat evaluation in obese population
timeFrame: at day 1
Secondary outcomes:
measure: Calcium scoring evaluation
timeFrame: at day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Lucie CASSAGNES
role: PRINCIPAL_INVESTIGATOR
References: