louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00151905: The Use of an Inhaled Salt Solution to Treat Viral Lung Infections in Infants.
Official title: Nebulized Hypertonic Saline in the Treatment of Bronchiolitis in Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Bronchiolitis
Keywords: bronchiolitis
hypertonic saline
Lead sponsor: Sheikh Khalifa Medical City
Sponsor class: OTHER
First posted: 2005-09-09
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Bronchiolitis is a common viral lung infection in infants. Standard treatment often includes the use of inhaled medications which are usually first mixed with a standard salt solution. Inhalation of a more concentrated salt solution (hypertonic saline) has been successfully used to treat other types of lung disease in children and adults. The purpose of this study is to see if using inhaled hypertonic saline helps infants with bronchiolitis get better more quickly.

Detailed description: Bronchiolitis is a common illness in infants and is associated with a significant morbidity. Standard therapy is controversial and largely ineffective; care is mostly supportive although nebulized medications continue to be commonly used. These medications are typically mixed with normal saline to produce a sufficient volume for efficient nebulization.

Inhaled hypertonic saline has been used to aid airway clearance in children with cystic fibrosis. It has also been used, in low dose, in two small studies in children with bronchiolitis. The current study is a randomized, double-blind, placebo-controlled, multi-center trial comparing frequent dosing with 3% hypertonic saline compared to normal saline in the treatment of infants hospitalized with bronchiolitis.

Eligibility criteria: Inclusion Criteria:

* Corrected age maximum 18 months, plus
* History of preceding viral upper respiratory tract infection, plus
* Presence of wheezing and/or crackles on auscultation, plus
* Respiratory Distress Assessment Instrument (RDAI) score of 4 or greater, or oxygen saturation of 93% or less in room air, plus
* Admitted to hospital

Exclusion Criteria:

* Prior history of wheezing, or
* History of chronic cardiopulmonary disease or immunodeficiency, or
* Critical illness at presentation requiring admission to ICU, or
* Use of nebulized hypertonic saline within previous 12 hours, or
* Prematurity (gestational age 34 weeks or less).

Primary outcomes:
measure: Length of stay.
Secondary outcomes:
Other outcomes:
Locations:
city: Victoria
country: Canada
facility: Victoria General Hospital
state: British Columbia
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: Abu Dhabi
country: United Arab Emirates
facility: Sheikh Khalifa Medical City
Study officials:
affiliation: Sheikh Khalifa Medical City
name: Brian A Kuzik, MD, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03668405: A Study to Evaluate the Long-term Safety and Tolerability of Lu AF20513 and the Antibody Response in Patients With Alzheimer's Disease (AD)
Official title: Interventional, Open-label, Multiple-immunization Extension Study on the Safety, Tolerability and Immunogenicity of Lu AF20513/Adjuvant in Patients With Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Alzheimer's Disease
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2018-09-12
Enrollment: 18
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
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 evaluate the long-term safety, tolerability and antibody response of Lu AF20513 in patients with Alzheimer's disease who have completed the 16026A study.


Eligibility criteria: Main inclusion criteria:

* The patient has completed the 16026A study and has received the last study treatment within 12 months of the screening visit for the present study.
* The patient has an MRI scan done in relation to study 16026A performed within 9 months before first study visit in the extension study.
* The patient has a knowledgeable and reliable caregiver/ study partner who will be available and able to accompany the patient to clinical visits, monitor Immunisation-Related Events after each immunisation, and participate with the patient at phone visits during the study

Main exclusion criteria:

* The patient uses or has recently used (pre-trial time limits specified in Appendix II) disallowed concomitant medication or it is anticipated that the patient will require treatment with at least one of the disallowed concomitant medications (Appendix II) during the study.
* The patient has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety and tolerability

More inclusion and exclusion criteria may apply

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
timeFrame: Baseline to week 96
measure: Aβ-specific antibody titre in plasma
timeFrame: Baseline to week 96
Secondary outcomes:
Other outcomes:
Locations:
city: Turku
country: Finland
facility: FI001
city: Malmö
country: Sweden
facility: SE002
city: Mölndal
country: Sweden
facility: SE003
city: Stockholm
country: Sweden
facility: SE001
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
Clinical trial NCT04785105: Natural History of Asymptomatic Superior Mesenteric Arterial Stenosis.
Official title: Natural History of Asymptomatic Superior Mesenteric Arterial Stenosis Depends on Celiac and Inferior Mesenteric Arteries Status.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stenosis
Keywords: SMA
Stenosis
Stenosis on scanner
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 77
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * patients with isolated \>70% SMA stenosis
* patients with both SMA stenosis and CA or/and IMA \>70% stenosis

Brief summary: The aim of this study was to evaluate asymptomatic superior mesenteric artery (SMA) stenosis prognosis according to the presence of coeliac artery (CA) and/or inferior mesenteric artery (IMA) associated stenosis.

Detailed description: BACKGROUND: The benefit of preventive treatment for SMA stenosis remains uncertain. The latest guidelines remain unclear given the lack of data in the literature.

Eligibility criteria: Inclusion Criteria:

* the presence of coeliac artery (CA) and/or inferior mesenteric artery (IMA) associated stenosis.

Exclusion Criteria:

-

Primary outcomes:
measure: Development of mesenteric disease defined as acute mesenteric ischemia or chronic mesenteric ischemia.
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Groupement Hospitalier Est
Study officials:
References:
Clinical trial NCT03269305: An Audit on Management of Chronic Diarrhea
Official title: An Audit on Management of Chronic Diarrhea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Diarrhea
Lead sponsor: Assiut University
Sponsor class: OTHER
Collaborators: name: Assiut University
First posted: 2017-08-31
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: an audit

Brief summary: The study is to assess whether the staff in gastroenterology unit are sticking to the agreed up on unit's protocol in management of chronic diarrhea over the period of one year(september 2017-september 2018)

Detailed description: chronic diarrhea is defined as having loose or watery stools more than three times aday.Awakening at night to pass stools us often sign of an organic cause of diarrhea.In some cases chronic diarrhea is the result of intestinal infection that persists longer than expected. In other cases chronic diarrhea is apart of a systemic illness.

Etiology:

1. post enteritis diarrhea syndrome in whic small intestinal mucosal damage persists after acute gastroenteritis.Also secondary disaccharidase deficiency and reinfection may be a cause.
2. infectious causes:enteric infection is an important cause.Associated conditions may be T.B or impaired immunity as in malnutrition potentiating the likely-hood of prolonging or acquiring another infection.Viral infection like Rota virus,parasites as E.coli,Giardia lamblia as well as amebiasis have been implicated in chronic diarrhea.
3. Cytomegalovirus on the other hand may act as an opportunistic agent in immuno compromised patients.
4. Non infectious causes include cow's milk allergy,lactose intolerance and inflammatory bowel disease,all of which may cause chronic diarrhea that is often associated with abdominal pain with or without elevated levels of inflammatory markers.
5. Malabsorption syndrome e.g Celiac disease,cystic fibrosis where the stools are usually fatty in nature and bulky in amount.

Good management of chronic diarrhea must include investigations and treatment.A protocol must be followed accurately therefore.

Methodology:

measurment of the degree of sticking of staff in Gastro-enterology unit to the agreed upon unit's protocol in management of chronic diarrhea over the period of one year (September 2017-September 2018).

Eligibility criteria: Inclusion Criteria:

* age group from 2 months to 18 years
* cases with diarrhea lasts 2 weeks or more
* Genetically free

Exclusion Criteria:

* age group from 0-2 months
* age group above 18 years
* cases with diarrhea less than 2 weeks
* Gentic disease

Primary outcomes:
measure: proper management of chronic diarrhea
timeFrame: september 2017-september 2018
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Gehad
Study officials:
affiliation: Assiut University
name: Faisal Alkhateeb, Phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT00510705: Chronic Inflammatory Activation in Fat Tissue: An Atherogenic Factor in Severe Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Severe Coronary Artery Disease
Obesity
Impaired Glucose Tolerance
Keywords: adiposity
Lead sponsor: University of Leipzig
Sponsor class: OTHER
Collaborators: name: Heart Center Leipzig - University Hospital
First posted: 2007-08-02
Enrollment: 29
Sex: MALE
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Chronic inflammatory activation in fat tissue can be the link between adiposity and an increased risk for atherosclerosis. The aim of this study is to investigate how molecular alterations in fat tissue can be influenced by regular physical exercise training alone or in combination with a medical therapy (glitazone or metformin) in obese patients with severe coronary artery disease (CAD) and impaired glucose tolerance.


Eligibility criteria: Inclusion Criteria:

* Either impaired glucose tolerance (2 hour plasma glucose concentration \> 7.8 and \< 11.1 mmol/L during an oral glucose tolerance test) or impaired fasting plasma glucose concentration ( \> 6.0 and \< 7.0 mmol/L)
* Body mass index (BMI) \> 25
* Severe coronary artery disease determined by coronary angiography
* Male patients aged 35-75 years

Exclusion Criteria:

* Diabetes mellitus type I
* Diabetes mellitus type II in combination with glycosylates hemoglobin \> 6.0%, previous medication with oral antidiabetic agents or insulin, fasting plasma glucose concentration \> 11.0 mmol/L
* Unstable angina pectoris
* Myocardial infarction within the last 4 weeks
* Reduced left-ventricular systolic function \< 30%

Primary outcomes:
measure: change in endothelial function in severe coronary artery disease
timeFrame: 4 weeks
Secondary outcomes:
measure: change in metabolic parameters
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: University of Leipzig - Heart Center
Study officials:
affiliation: Heart Center Leipzig - University Hospital
name: Gerhard Schuler, Prof. of Medicine
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04707105: Prospective Cohort Study of Intracerebral Hemorrhage
Official title: A Prospective Observational Cohort Study in Chinese Patients With Primary Intracerebral Hemorrhage
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intracerebral Hemorrhage
Keywords: primary intracerebral hemorrhage
hypertension
perihematomal edema
secondary brain injury
remote diffusion-weighted imaging lesions (R-DWILs)
immune response
multimodel image
cohort
MRI
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-01-13
Enrollment: 856
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: 856 hospitalized patients over 18 years old with primary intrcerebral hemorrhage will be enrolled consecutively.

Brief summary: The investigators design a prospective, observational cohort study to provide contemporary information on the prevalence, characteristics, risk stratification，cost-effective ,treatments and prognosis of Chinese hospitalised adult patients with intracerebral hemorrhage.

Detailed description: Intracerebral hemorrhage (ICH) remains a devastating disease with high mortality, yet few therapeutic managements have been proved effective. Large quantities of work needs to be done to fully delineate the prevalence and prognosis of ICH. Hence, the investigators design a prospective, observational cohort study to provide contemporary information on the prevalence, characteristics, risk stratification，cost-effective, treatments and prognosis of Chinese hospitalised adult patients with ICH.

Eligibility criteria: Inclusion Criteria:

* Hospitalized patients over 18 years old of primary intracerebral hemorrhage.

Exclusion Criteria:

1. patients of secondary intracerebral hemorrhage，such as hemorrhagic transformation of ischemic stroke, aneurysmal, cavernomas, arterio- venous malformations, central venous thrombosis, trauma-related, or tumor.
2. isolated intraventricular hemorrhage or subarachnoid hemorrhage pregnant patients；
3. surgical evacuation of hematoma；
4. unavailability to get complete blood cell samples and presenting contraindications or refusal to MRI
5. patients cannot be followed up for any reasons.
6. patients death in 24 hours
7. pregnant patients

Primary outcomes:
measure: proportion of patients with a 3-month modified Rankin Scale (mRS) score≤ 3
timeFrame: 2-3years
Secondary outcomes:
measure: Absolute peripheral hematoma edema(PHE) growth
timeFrame: 2-3years
measure: Relative peripheral hematoma edema(rPHE)
timeFrame: 2-3years
measure: National institute of health stroke scale（NIHSS score）
timeFrame: 2-3years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine at Zhejiang University
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Feng Gao, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04399005: The Efficacy Comparing Daily and After-each-case Room Disinfection.
Official title: The Efficacy Comparing Daily and After-each-case Room Disinfection in the Endoscopy Unit During the COVID-19 Pandemic.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Daily Room Disinfection
After-each-case Room Disinfection
Lead sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
First posted: 2020-05-22
Enrollment: 240
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of our study was to evaluate the difference of effectiveness between daily and after-each-case room disinfection in the endoscopy unit during the COVID-19 pandemic.

Detailed description: This study divided into 2 groups: daily room disinfection and after-each-case room disinfection. Each group was also subdivided into general anesthesia or non-general anesthesia gastroscopy, and with or without ventilation consultation room.

Samples collection include: operation unit air (six-stage sieve percussion air sampler for sampling, airflow rate 28.3L/min, sampling time 4 min); workstation's mouse (wiping sterile cotton for sampling); endoscopist's gown, control panel buttons, and patient's bed headboard (contact plate for sampling).

Eligibility criteria: Inclusion Criteria:

* All the cases received gastroscopy.

Exclusion Criteria:

* High-risk personal through contact history, symptoms, body temperature, COVID-19 virus nucleic acid testing and chest computed tomography (CT) scan.

Primary outcomes:
measure: Qualified rate of room disinfection
timeFrame: 48 hours
measure: The number of colony-forming units (CFU)
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: First Affiliated Hospital of Zhejiang Chinese Medical University
state: Zhejiang
Study officials:
affiliation: First Affiliated Hospital of Zhejiang Chinese Medical University
name: Bin Lu
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jin B, Hu Y, Huang L, Cheng X, Zhao J, Yang X, Sun X, Gan T, Lu B. Effectiveness Between Daily and After-Each-Case Room Disinfection of the Endoscopy Unit. Front Public Health. 2021 Oct 5;9:700041. doi: 10.3389/fpubh.2021.700041. eCollection 2021.
Clinical trial NCT01605305: Study on FOLFOX6 as First-line Therapy to Treat Recurrent or Metastatic Esophageal Cancer
Official title: Phase II Study on FOLFOX6 as First-line Therapy to Treat Recurrent or Metastatic Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Esophageal Squamous Cell Carcinoma
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2012-05-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to explore whether FOLFOX6 as treatment could improve the time to progression (TTP) and overall survival (OS) of the patient with recurrent or metastatic esophagus.

Detailed description: Explore whether FOLFOX6 as treatment could improve the TTP and OS of the patient with recurrent or metastatic esophagus

Eligibility criteria: Inclusion Criteria:

1. Histologically proven primary thoracic esophageal squamous cell carcinoma
2. Without chemotherapy or neo-adjuvant chemotherapy in 6 weeks ,radiotherapy has end at least 1 month,target lesion was not in an irradiated area.
3. Presence of at least one index lesion measurable by CT scan or MRI
4. 18\~75 years
5. kps ≥ 70
6. Life expectancy of ≥ 3 months
7. ANC ≥ 2×109/L，PLT ≥ 100×109/L，Hb ≥ 90g/L
8. Cr ≤ 1.0×UNL
9. TB ≤ 1.25×UNL； ALT/AST ≤ 2.5×UNL，THE patient with liver metastasis ALT/AST ≤ 5.0×UNL；AKP ≤ 2.5×UNL
10. Signed written informed consent

Exclusion Criteria:

1. Previous exposure to oxa therapy in one year
2. diameter of tumor abdominal ≥ 10cm, Total volumes of liver lesions ≥ 50%,lung metastasis ≥ 25% total lung
3. chronic diarrhea,enteritis,intestine obstruction which are not under control
4. Psychiatric or addictive disorders that preclude obtaining informed consent or adherence to protocol.
5. peripheral neuropathy ≥ CTCAE 1
6. Other serious disease
7. Previous or concomitant malignancies except non-melanoma skin cancer, carcinoma in situ of the cervix, and invasive carcinoma of the colon, thyroid, cervix, or endometrium treated five years prior to study entry.
8. USE OTHER ANTITUMOR THERAPY
9. Breast-feeding or pregnant women, no effective contraception if risk of conception exists

Primary outcomes:
measure: TPP
timeFrame: from the first cycle of treatment (day one) to two month after the last cycle
Secondary outcomes:
measure: OS
timeFrame: from the first cycle of treatment (day one) to two month after the last cycle
Other outcomes:
Locations:
Study officials:
affiliation: Fudan University
name: chang j h, post-doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02839005: Absorbable Suture Versus Nonabsorbable Suture Intradermal for the Skin Transverse Section in Cesarean
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section
Sutures
Keywords: Wound Closure Thechnical
Wound Healing
Lead sponsor: Universidade do Vale do Sapucai
Sponsor class: OTHER
First posted: 2016-07-20
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Context: Cesarean section is the most common surgery in women, both in developed and underdeveloped countries. However results are conflicting report in which material for intradermal suturing get better aesthetic result. Objective: To compare the aesthetic appearance of two suture materials, polyglecaprone 25 and polyamide (nylon) with intradermal sutures for skin closure in women undergoing cesarean section first. Methods: This is a clinical, prospective and randomized study which was conducted in the Department of Gynecology and Obstetrics of a tertiary Institute, Hospital das Clinicas Samuel Libânio, in PousoAlegre, Estate of Minas Gerais. Sixty women undergoing cesarean section were first included and randomized into two groups: group I (n = 30) polyamide and group II (n = 30) polyglecaprone 25. Hypertrophy, color and width of the wound were evaluated, receiving a score, according to Trimbos table, six months after surgery. Later the results were compared to non-parametric statistical tests


Eligibility criteria: Inclusion Criteria:

* Patients who underwent cesarean section
* No restriction of ethnicity, education or social class

Exclusion Criteria:

* Scarring Pfannenstiel prior
* Diabetic patients using drugs;
* Patients with collagen diseases
* Patients with pre operative tests to indicate any systemic sign of infection or site, not previously treated until the time of surgery.
* Patients who withdrew informed consent
* Patients who did not attend the pre scheduled dates for the controls after surgery .

Primary outcomes:
measure: Photographic documentation for evaluation
timeFrame: 6 Months
measure: Photographic documentation for evaluation
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Pouso Alegre
country: Brazil
facility: Hospital das Clínicas Samuel Libânio
state: Minas Gerais
Study officials:
References: