louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00222170: Rabeprazole in Subjects With Gastroesophageal Reflux Disease (GERD)
Official title: Esophagoprotection by Rabeprazole Mediated by Restoration of an Impairment in Esophageal Mucin Production: Its Potential Therapeutic Benefit in Patients With Gastroesophageal Reflux Disease (GERD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Esophageal Reflux
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: PriCara, Unit of Ortho-McNeil, Inc.
name: Eisai Inc.
First posted: 2005-09-22
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the production of mucin in GERD/RE subjects before and after 8 weeks of treatment with rabeprazole.

Detailed description: Enrolled patients will undergo collection of salivary and esophageal secretions. Subsequently, all patients will receive rabeprazole (20mg QD) for 8 weeks and will be re-endoscoped to confirm complete healing of reflux esophagitis. In patients with completely healed reflux esophagitis the second collection of salivary and esophageal secretion will be implemented. In both secretions, adequately coded for the laboratory Research Fellow (blinded in terms of which sample is collected before and which after treatment with rabeprazole) the content of mucin will be measured using commercially available assay and its secretion expressed in units per minute of collection time.

Eligibility criteria: Inclusion criteria: 24 patients with endoscopically confirmed reflux esophagitis (Grades A-D according to LA classification) in patients with chronic symptoms of GERD (heartburn with or without regurgitation) between the age of 19 and 79, 12M \& 12F, will be included.

Exclusion criteria: History of GI surgery, primary esophageal motor disorders, any systemic disease, history of drug or alcohol abuse, pregnancy or nursing, allergy to the same drug class as rabeprazole, the need for any concurrent therapy that affects salivary secretion (causing so-called "dry mouth syndrome").

Primary outcomes:
measure: Measure of concentration and output of esophageal mucus in esophageal secretion before and after 8 weeks of therapy with rabeprazole
Secondary outcomes:
measure: Esophageal mucin measurement comparisons on samples collected before and after rabeprazole therapy
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Jerzy Sarosiek, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Kansas Medical Center
name: Mojtaba S. Olyaee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02009670: Inulin,SCFA Production and Metabolic Response
Official title: SCFA Production and Their Metabolic Effects After Inulin Ingestion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Obesity
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Top Institute Food and Nutrition
First posted: 2013-12-12
Enrollment: 15
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: In this placebo controlled, double-blind, randomized crossover study the investigators will investigate in overweight/obese healthy male volunteers whether inulin administration will increase intestinal SCFA production, thereby investigating whether this will lead to acute metabolic effects.

Detailed description: Gut microbiota is being increasingly recognized as an important factor in fat distribution, insulin sensitivity and glucose and lipid metabolism. Accordingly, the intestinal microbiota could play an important role in the development of obesity and type 2 diabetes mellitus. The role of gut-derived short-chain fatty acids (SCFA), the formation of which is enhanced by microbial fermentation of fibre, is still controversial. At the present time, our understanding of the effects of SCFA on human metabolism (in gut or systemically) is still limited. The investigators hypothesize that the ingested prebiotic inulin is fermented into SCFA and these SCFA have metabolic effects.

Eligibility criteria: Inclusion Criteria:

* Overweight, obese men

Exclusion Criteria:

* athletes
* diabetes mellitus

Primary outcomes:
measure: Fat oxidation, energy expenditure
timeFrame: 1 study day for each administration
Secondary outcomes:
measure: Hormones that influence substrate and energy metabolism
timeFrame: 1 study day for each administration
measure: Circulating metabolites
timeFrame: 1 study day for each administration
measure: Appetite VAS scoring
timeFrame: 1 study day for each administration
measure: SCFAs
timeFrame: 1 study day for each administration
measure: Breath sampling 13CO2
timeFrame: 1 study day for each administration
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
Study officials:
affiliation: Maastricht University Medical Center
name: CHC Dejong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van der Beek CM, Canfora EE, Kip AM, Gorissen SHM, Olde Damink SWM, van Eijk HM, Holst JJ, Blaak EE, Dejong CHC, Lenaerts K. The prebiotic inulin improves substrate metabolism and promotes short-chain fatty acid production in overweight to obese men. Metabolism. 2018 Oct;87:25-35. doi: 10.1016/j.metabol.2018.06.009. Epub 2018 Jun 25.
Clinical trial NCT00188175: IMRT Lower Limb Soft Tissue Sarcoma
Official title: A Phase II Study of Preoperative Intensity-Modulated Radiation Therapy For Lower Limb Soft Tissue Sarcoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sarcoma
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Ontario Cancer Research Network
First posted: 2005-09-16
Enrollment: 59
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Intensity-modulated radiation therapy may make wound healing problems less likely by 1)precisely shaping the region of high radiation dose to the shape of the tissue which harbours tumour cells, and 2) precisely shaping the regions of low radiation dose to the shapes of the normal tissues which are more sensitive to radiation effects.


Eligibility criteria: Inclusion Criteria:

* Histologically proven soft tissue sarcoma
* Lesion lies between the iliac crest (hipbone) and the ankle
* Lesion is newly diagnosed
* Assessed by radiation oncologist and surgical oncologist

Exclusion Criteria:

* Benign histologies
* Histologies generally treated with chemotherapy
* Prior or recurrent cancer, except nonmelanomatous skin cancer or carcinoma in-situ of the cervix

Primary outcomes:
measure: Major wound complications within 120 days following surgery
timeFrame: 120 days post-op
Secondary outcomes:
measure: Assess acute and late radiation toxicity including limb edema
timeFrame: up to120 days
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: Princess Margaret Hospital, Canada
name: Brian O'Sullivan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05670275: Microecology and Host Immunity in Patients With Severe COVID-19 Infection
Official title: Microecology and Host Immunity in Patients With Severe COVID-19 Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Microbiome,Immune Function, Critically Ill
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2023-01-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with severe COVID-19 infection after endotracheal intubation

Brief summary: The purpose of this study was to analyze the relationship between the microbial community, host immunity and the prognosis of patients with severe COVID-19.

Detailed description: Methods: Bronchoalveolar lavage specimens of patients with severe COVID-19 were collected and studied to analyze the relationship between the composition of patients' microecology and the occurrence and development of disease.

Eligibility criteria: Inclusion Criteria:

* 1) Respiratory distress, respiratory rate ≥ 30 times/minute

  2) At rest, oxygen saturation ≤ 93%

  3）PaO2/FiO2 ≤300mmHg

  4) Shock

  5) Respiratory failure requires mechanical ventilation

  6) Complicated with other organ failure requires ICU monitoring and treatment

  7) Or in case of any of the following conditions, even if none of the above conditions is found, it is also managed as a critical case: ① pulmonary imaging shows that the lesion has significantly progressed more than 50% within 24-48 hours; ② Age\>60 years old; ③ Complicated with serious chronic diseases (including diabetes, hypertension, coronary heart disease, malignant tumor, structural lung disease, pulmonary heart disease and immunosuppressed population)

Exclusion Criteria:

* 1) Pregnant women

  2) Age\<18

  3) Mental disorders

  4) Patients with long-term mechanical ventilation for more than 60 days

  5) Disagreement group researcher

Primary outcomes:
measure: death
timeFrame: 28 day
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: PLA
state: Beijign
Study officials:
References:
Clinical trial NCT04487275: MLC901 for Moderate to Severe Traumatic Brain Injury (Specified Drug Code)
Official title: MLC901 for Moderate to Severe Traumatic Brain Injury: Pilot, Randomized, Double-Masked, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Traumatic Brain Injury
Lead sponsor: Shahid Beheshti University
Sponsor class: OTHER
First posted: 2020-07-27
Enrollment: 80
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with a diagnosis of moderate to severe traumatic brain injury (TBI) will be enrolled. Subjects will be randomly assigned to receive either MLC901 (Specified Drug Code) or placebo capsules three times per day over 6 months. Evaluation of patients will be carried out at baseline as well as at 3-month and 6-month follow-up visits. Modified Rankin Scale (mRS) and Glasgow outcome scale (GOS) will be used to examine patients. Efficacy will be evaluated by comparing these two scores between the 2 groups at follow-up visits.


Eligibility criteria: Inclusion Criteria:

* age between 15 and 65
* non-penetrating moderate (Glasgow Coma Scale score \[GCS\] 9-12) or severe (GCS 3-8) traumatic brain
* injury less than 24 hrs from traumatic injury
* anticipated intensive care unit length of stay at least 48 hrs

Exclusion Criteria:

* GCS = 3 and fixed dilated pupils or penetrating injury
* coexisting injury or medical conditions which could adversely affect our study outcome measures
* dependence for everyday activities before the injury
* pregnancy or breastfeeding
* known allergy to any of MLC901 components

Primary outcomes:
measure: functional outcome 1
timeFrame: at baseline
measure: functional outcome 2
timeFrame: at 3rd month post-injury
measure: functional outcome 3
timeFrame: at 6th month post-injury
measure: functional outcome 4
timeFrame: at baseline
measure: functional outcome 5
timeFrame: at 3rd month post-injury
measure: functional outcome 6
timeFrame: at 6th month post-injury
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Brain Mapping Research Center
Study officials:
References:
Clinical trial NCT05706675: Specialized Pro-resolving Mediators (SPM) as Biomarkers of Periodontal Inflammation
Official title: Specialized Pro-resolving Mediators (SPM) as Biomarkers of Periodontal Inflammation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inflammation
Periodontitis
Lead sponsor: University of Sharjah
Sponsor class: OTHER
First posted: 2023-01-31
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Periodontal diseases are a public health burden in all countries. Hence, Periodontitis is the sixth-most prevalent disease in the world, the most common bone diseases in human and the primary cause for tooth loss in adults leading to significant economic and medical consequences. All disease biomarkers could help to stratify the general population with those at high risk of periodontitis and to enroll them in a rigorous prevention program. Advanced periodontitis has been shown to reduce the quality of life of patients and developing novel biological monitoring protocols will reduce the prevalence of advanced forms of the disease.

There are alot of research explaining the different types of inflammatory mediators that could be found in periodontitis patients. But there are a few research have been talking about lipoxin A4 as an inflammatory biomarker that could detect the effect of non surgical periodontal therapy effect on the periodontal health.

And the aim of the study is to assess the effect of this non surgical periodontal therapy on the periodontal health by assessing the concentration of this biomarker.


Eligibility criteria: Inclusion Criteria:

* Control group : Patients diagnosed as periodontally healthy
* Test group:

  * Patients diagnosed with generalized periodontitis (Stage 3/4, Grade a,b or c).
  * Having at least 15 remaining teeth.
  * Mentally able to understand the communication and to express an informed consent

Exclusion Criteria:

* Systemic diseases with known effect on periodontal health
* Antibiotics/Anti-inflammatory drugs taken in the last month
* Women with suspected/known pregnancy, or taking any hormone-based treatment
* Patients suffering from Xerostomia.
* Patients smoking more than 20 cig/day.
* Previous periodontal therapy in the last 3-6 months

Primary outcomes:
measure: Lipoxin A4
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sharjah
country: United Arab Emirates
facility: University Dental Hospital Sharjah
Study officials:
affiliation: University of Sharjah
name: Prof. Zahi Badran, Phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT01108575: Effect of Inspiratory Muscle Training on Duration of Mechanical Ventilation Support
Official title: Inspiratory Muscle Strength Training in Ventilator Dependent Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Respiratory Failure
Keywords: Mechanical ventilation
mechanical ventilation weaning
inspiratory muscle strength training
Patients admitted to a surgical intensive care unit who are expected to receive mechanical ventilation for more than three days.
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2010-04-22
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A growing body of knowledge has documented that the diaphragm, the primary muscle of breathing, atrophies and weakens within days of instituting mechanical ventilation support. Diaphragm weakness has been implicated as a major contributor to difficulty with weaning, or breathing without ventilator support. This study will test whether instituting a diaphragm strength training rehabilitation program will reduce the time patients require mechanical ventilation in a surgical intensive care setting.


Eligibility criteria: Inclusion Criteria:

1. Admission to general surgical intensive care unit with respiratory failure and expected to require mechanical ventilation support for more than 72 hours.

Exclusion Criteria:

1. inability to follow simple, one step commands such as "inspire forcefully",
2. patients with prior arrangements to be transferred to other facilities when stabilized,
3. any contraindications to disconnecting pt from ventilator for SHAM or IMST treatment,
4. unstable or difficult airway upon ICU admission and predicted to last for more than 72 hours,
5. use of more than minimal vasopressor or vasodilatatory agents as a continuous infusion,
6. severe dysrhythmias,
7. acute coronary syndrome
8. pulmonary contraindications (pneumon/hemothorax, flail chest),
9. acute surgical problems arising in the immediate post operative period (serious postoperative bleeding, wound dehiscence, etc). When and if these problems resolve and the patient meets other entry criteria, they will be eligible to be recruited for participation.
10. active neuromuscular diseases that would prevent or interfere with responding to strength training (e.g., amyotrophic lateral sclerosis, multiple sclerosis, myasthenia gravis, polymyositis, muscular dystrophy or other dystrophies and myopathies)
11. spinal cord injuries.

Primary outcomes:
measure: Duration of mechanical ventilation support
timeFrame: Patients will be observed for up to 28 days following admission to the ICU
Secondary outcomes:
measure: Maximal inspiratory pressure
timeFrame: Patients will be observed for up to 28 days following admission to the ICU
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Shands Hospital at the University of Florida
state: Florida
Study officials:
References:
Clinical trial NCT00877175: Comparison of Instillation and Packing in Mydriasis for Premature Infants
Official title: Comparison of Conventional Instillation and Lower Conjunctival Fornix Packing in Mydriasis for Premature Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Preterm Infants
Keywords: preterm infants
mydriasis
pupil dilation
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2009-04-07
Enrollment: 25
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to compare the mydriatic effect of 2.5% phenylephrine and 1% tropicamide by conventional instillation and lower conjunctival fornix packing in premature infants.

Detailed description: Adequate pupil dilatation was needed for screening and treatment of retinopathy of prematurity (ROP) in premature infants.In general clinical practice, mydriatic drugs were instilled many times until the pupil reached the maximum size. However, poor mydriasis were found in many eyes despite maximum instillation was used. From the clinical observation, we found the packing of mydriatic drugs in lower conjunctival fornix was much more effective to dilate the pupil than instillation in some patients. The purpose of this study was to compare the mydriatic effect of 2.5% phenylephrine and 1% tropicamide by conventional instillation and lower conjunctival fornix packing in premature infants.

Eligibility criteria: Inclusion Criteria:

* gestational age of less than 32 weeks and/or the birth weight of less than 1,500 grams
* stable clinical course

Exclusion Criteria:

* history of intraocular surgery or laser treatment
* previous eyedrop instillation that might affect the pupil size
* severe underlying disease or unstable clinical course that mydriatic drugs or the examination could aggravate their conditions

Primary outcomes:
measure: The primary outcome measure was the horizontal pupil diameter measured with a ruler in millimeters
timeFrame: 40 minutes after mydriatric drugs
Secondary outcomes:
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital
Study officials:
affiliation: Department of Ophthalmology, Faculty of Medicine, Khon Kaen University
name: Yosanan Yospaiboon, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thanathanee O, Ratanapakorn T, Morley MG, Yospaiboon Y. Lower conjunctival fornix packing for mydriasis in premature infants: a randomized trial. Clin Ophthalmol. 2012;6:253-6. doi: 10.2147/OPTH.S28714. Epub 2012 Feb 15.
Clinical trial NCT03130075: Reliability and Validity of the Turkish Version of Caregiver Functional Use Survey (CFUS)
Official title: Reliability and Validity of the Turkish Version of Caregiver Functional Use Survey (CFUS)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebral Palsy
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 50
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children with Hemiplegia Cerebral Palsy

Brief summary: Increasing the number of Turkish version of the questionnaire evaluating hand use, adding the scales that evaluate the selective movements of the upper limb to the evaluations will increase the variety of evaluation methods.

The purpose of this study is to evaluate the validity and reliability of the Turkish version of the Caregiver Functional Use Survey (CFUS)

Detailed description: CFUS was designed to assess caregivers' perceptions of how much and how well their child used the involved upper extremity.

Children's upper extremity functions will be assessed with a Jebsen Taylor Hand Function Test. Their family will be asked to fill the CFUS.

Compare the relationship between Jebsen-Taylor Hand Function Test and Turkish Version CFUS. Investigate the internal consistency of Turkish-version of CFUS by using Cronbach's alpha coefficient.

Eligibility criteria: Inclusion Criteria:

* Ages between 3-15 years
* Diagnosed as Cerebral Palsy (Hemiplegia)
* Literate in Turkish language and can complete the questionnaire by primer caregiver

Exclusion Criteria:

* Cannot understand the questionnaire by themselves.
* Participants had a botulinum toxin injection within the last 6 months
* Any surgical correction within the last year

Primary outcomes:
measure: Validity of Caregiver Functional Use Survey (CFUS)
timeFrame: 8 week
Secondary outcomes:
measure: Reliability of CFUS
timeFrame: 8 week
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
Study officials:
affiliation: Study chair
name: Bülent Elbasan
role: STUDY_CHAIR
References: