louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01886482: Effect of High Protein Diet on Cardiovascular Diseases Risk Factors Among Overweight and Obese Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Body Mass Index Quantitative Trait Locus 7 Disorder
Tangier Disease
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-06-26
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators aimed to determine the effects of HP diet on CVD risk factors among overweight and obese children.

Detailed description: Background: Studies regarding the effects of high protein (HP) diet on cardiovascular (CVD) risk factors have reported contradictory results.

Objective: In present study, the investigators aimed to determine the effects of HP diet on CVD risk factors among overweight and obese children.

Design: In this randomized controlled trial, the investigators recruited 50 overweight and obese women, aged 6-11years into HP or control energy restricted diets for 10 weeks (protein, carbohydrate, fat: 25%, 45%, 30% vs. 15%, 55%, 30%, respectively). Total protein amount, divided to animal and plant sources in 50%-50% and animal sources distributed (half/half) between meats and dairy products. Fasting blood samples, lipid profile, systolic and diastolic blood pressure and anthropometric measurements were measured based on the standard guidelines.

Eligibility criteria: Inclusion Criteria:

* BMI \> 85th age of 6-11 years
* no history of chronic diseases
* no taken medications

Exclusion Criteria:

* do not prescribe their diet
* mental retardation

Primary outcomes:
measure: the amount of weight reduction in two dietary groups
timeFrame: 10 weeks
Secondary outcomes:
measure: LDL (mg/ml)
timeFrame: 10 weeks
measure: HDL (mg/ml)
timeFrame: 10 weeks
measure: fasting blood glucose
timeFrame: 10 weeks
measure: total cholesterol (mg/dl)
timeFrame: 10 weeks
measure: blood pressure
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Isfahan University of Medical Sciences
Study officials:
References:
Clinical trial NCT01694082: Brief Web-Based Alcohol Reduction Intervention for Undergraduates
Official title: Randomized, Controlled Trial of a Brief, Web-Based Alcohol Reduction Intervention for Undergraduates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use
Heavy Drinking
Negative Consequences of Alcohol Use
Keywords: brief intervention
web-based interventions
computer-based interventions
harm reduction
young adult
college student
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Alcoholic Beverage Medical Research Foundation
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2012-09-26
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Tertiary Health Research Intervention Via Email (THRIVE; Kypri et al., 2009), originally utilized with Australian students, is unique in that it contains efficacious components derived from motivational interviewing (e.g., personalized feedback) and cognitive behavioral therapy (protective behavioral strategies), yet is very brief and has established efficacy. This study aims to test versions of THRIVE tailored to American college students. In addition to replicating original results with THRIVE, we will also test versions containing unique subsets of protective behavioral strategies to reduce alcohol consumption. The primary hypothesis is that versions of THRIVE will be associated with lower overall alcohol consumption than an assessment and brief brochure control condition.


Eligibility criteria: Inclusion Criteria:

* Must be a current student at Albertus Magnus College in New Haven, CT

Exclusion Criteria:

* Under 18 years of age
* 25 years of age or older

Primary outcomes:
measure: Frequency of alcohol use
timeFrame: 1-month post-intervention
measure: Protective behavioral strategy use
timeFrame: 1-month post-intervention
measure: Overall Weekly Alcohol Consumption
timeFrame: 1-month post-intervention
Secondary outcomes:
measure: Frequency of heavy drinking days
timeFrame: 1-month post-intervention
measure: Frequency of alcohol use
timeFrame: 6-months post-intervention
measure: Overall weekly alcohol consumption
timeFrame: 6-months post-intervention
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Robert F Leeman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06043882: Number of Participants Diagnosed With Sarcoidosis by Bronchoscopic Transbronchial Needle Aspiration After COVID- 2019 .
Official title: Number of Participants Diagnosed With Sarcoidosis by Bronchoscopic Transbronchial Needle Aspiration After Corona Virus Disease of 2019 Infection.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcoidosis
COVID-19
Keywords: Sarcoidosis
COVID-19
SARS-CoV-2
Granulomatous disease
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients previously diagnosed as COVID -19 by RT-PCR ,with mediastinal or hilar lymphadenopathy with or without lung infiltrates referred to bronchoscopy unit ,Chest Department, Ain-Shams University Hospital for diagnosis.

Brief summary: The goal of this observational study is to learn about sarcoidosis development after COVID-19 infection.

The main question it aims to answer is:

* prevalence of Sarcoidosis among patients previously infected with COVID-19.

Participants will:

* provide previous positive RT-PCR for COVID-19
* Have computed tomography of the Chest with suggestive findings of sarcoidosis
* Have bronchoscopic guided biopsies and pathological analysis to detect number of patients with sarcoidosis.

Detailed description: This prospective cross sectional study was performed on a total of 55 patients with mediastinal and /or hilar lymphadenopathy with or without lung infiltrates referred to Bronchoscopy unit , Chest department, Ain-Shams University hospital for biopsy taking and diagnosis.

All patients were subjected to the following : history taking , clinical examination , radiological assessment by computed tomography (CT )chest , fiberoptic bronchoscopy where biopsies were taken either by conventional-Trans-bronchial needle aspiration (c-TBNA) , endo-bronchial ultrasound (EBUS-TBNA) or direct forceps biopsies and sent for histopathological examination and if the patient had past history of COVID-19 infection with previous positive reverse transcriptase- polymerase chain reaction assay (RT-PCR).

Eligibility criteria: Inclusion Criteria:

* All adult patients with previous positive RT-PCR for COVID -19 and CT chest findings of mediastinal and or hilar lymphadenopathy with or without lung infiltrate will be included. .

Exclusion Criteria:

* Patients younger than 18 years old Patients
* Patients refuse to participate in the study
* Patients previously diagnosed as sarcoidosis

Primary outcomes:
measure: Number and risk factors of sarcoidosis development after COVID -19 infection as diagnosed by TBNA guided tissue biopsies in bronchoscopy unit, chest department, Ain Shams university.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Hoda atiatullah
Study officials:
affiliation: faculty of medicine, Ain Shams university
name: Hoda A Mohamed, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02117882: Minimally Invasive Lateral Approach for Sinus Augmentation: a Split-mouth Randomized Clinical Trial.
Official title: Minimally Invasive Lateral Approach for Sinus Augmentation: a Split-mouth Randomized Clinical Trial.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Involvement in Diseases Classified Elsewhere
Keywords: lateral approach, bone augmentation , sinus floor elevation
Lead sponsor: University of Firenze and Siena, Napoli, Italy
Sponsor class: OTHER
First posted: 2014-04-21
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 15 patients edentulous in maxillary posterior area have been treated with a bilateral sinus lift procedure.

Brief summary: It is assumed that the minimally invasive lateral approach and the traditional lateral sinus lift procedure will result in better outcomes in terms of height of augmented bone.

It is also assumed that the minimally invasive lateral approach will reduce surgical complications and patient's discomfort in comparison with a traditional lateral sinus lift procedure.

Detailed description: 16 patients edentulous in maxillary posterior area will be treated with a bilateral sinus lift procedure.

Once a patient will be enrolled in the study impressions will be taken. After the wax-up, a radiographic stent will be prepared. Special attention will be given to position radio-opaque references in the positions where the implants will be inserted according to a prosthodontic guided insertion. Pre-surgical CT scan will be executed after placing the stent in its proper position in patient's mouth. After that, if no surgical contra-indications will be detected at CT evaluation, patients will be enrolled for surgical interventions.

Eligibility criteria: Inclusion Criteria:

* - patient edentulous in the maxillary posterior area on both left and right side( not completely edentulous).
* - residual bone height in the maxillary premolar and molar region less than 4mm.

Exclusion Criteria:

* - history of systemic diseases that would contraindicate surgical treatment

Primary outcomes:
measure: height of augmented bone
timeFrame: 6 months
Secondary outcomes:
measure: post surgical patient's discomfort
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Siena
country: Italy
facility: Siena University, Department of Periodontology, Policlinico Le Scotte Siena.
Study officials:
affiliation: tuscan school of dental medicine of florence and siena
name: nicola nb baldini, oral surgeon
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02154282: iPod Games in Hepatic Encephalopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatic Encephalopathy
Cirrhosis
Keywords: hepatic encephalopathy
covert hepatic encephalopathy
cirrhosis
Lead sponsor: Hunter Holmes Mcguire Veteran Affairs Medical Center
Sponsor class: FED
First posted: 2014-06-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To see if using ipod games can improve mental functioning


Eligibility criteria: Inclusion Criteria:

* Cirrhosis proven by biopsy, radiology or endoscopy
* Age 18-70
* Able to give informed consent
* Cognitive dysfunction defined by impaired performance on standard cognitive tests

Exclusion Criteria:

* Illicit drug or alcohol use within 3 months
* Trans-jugular intra-hepatic porto-systemic shunt (TIPS) placement
* Need for psychoactive medications apart from continuous anti-depressants or methadone
* Any focal neurological deficit or neuro-muscular disease
* Inability to function with an iPod
* Inability to understand English

For MRI: inability to perform brain MRI is an exclusion

Primary outcomes:
measure: Improvement in cognitive test performance with iPod games
timeFrame: 8 weeks
Secondary outcomes:
measure: Improvement in health-related quality of life
timeFrame: 8 weeks
measure: Improvement in brain MRI parameters
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Hunter Holmes McGuire VA Medical Center
state: Virginia
Study officials:
References:
Clinical trial NCT05243082: Endoscopic Ultrasound Guided Radio Frequency Ablation of Pancreatic Neuroendocrine Neoplasms
Official title: Endoscopic Ultrasound Guided Radio Frequency Ablation of Pancreatic Neuroendocrine Neoplasms
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pancreatic Neuroendocrine Tumors, WHO Grade I-II
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Haukeland University Hospital
name: St. Olavs Hospital
name: University Hospital of North Norway
First posted: 2022-02-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A national multicenter prospective study to investigate the feasibility and efficacy of endoscopic ultrasound guided radiofrequency ablation of neuroendocrine pancreatic tumors, WHO Grade 1-2 of 3 cm or less in diameter.


Eligibility criteria: Inclusion Criteria:

* Age above 18
* EUS fine needle biopsy (FNB) proven pancreatic neuroendocrine tumor (PNET), WHO 2019 Grade 1-2 in patients with functioning or non-functioning tumors. Also

MEN1 patients are eligible:

* PNET 2-3 cm in largest diameter (Based on MRI or CT) with a Ki-67 \<5%, or:

  * PNET \< 2cm with Ki-67 \<10% that has shown progression during surveillance, or:
  * PNET 1.5-2 cm with Ki-67 \<10% in patients age \< 60 years of age, whether progression is detected or not.
* Distance from the main pancreatic duct ≥2 mm, or \<2mm with a prophylactic stent in the main pancreatic duct.
* Patient in good general condition, ECOG performance status 0-2 (see Appendix)
* Signed written informed consent

Exclusion Criteria:

* Pregnancy.
* Life expectancy \< 1 year
* Severe hemostasis disorders
* Pancreatic and/or biliary ductal dilation
* Evidence of active pancreatitis
* Metastatic disease, including local lymph node metastases
* Use of anticoagulants that cannot be discontinued
* INR \>1.5 or platelet count \<50.00
* Distance from the main pancreatic duct \<1 mm, and placement of a pancreatic stent is not possible
* Patient being managed for another malignant lesion which is progressive or under treatment

Primary outcomes:
measure: Adverse events
timeFrame: Up to 12 months
measure: Residual disease
timeFrame: Up to 5 years
measure: Metastatic disease
timeFrame: Up to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
References:
Clinical trial NCT04624282: Metabonomics Study of Chronic Gastritis and Gastric Carcinoma
Official title: Metabonomics Study of Chronic Gastritis and Gastric Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Cancer
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2020-11-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will enroll patients with chronic superficial gastritis, chronic atrophic gastritis or gastric carcinoma.

Brief summary: The pathogenetic mechanisms of chronic gastritis and gastric carcinoma are different. Whether metabonomics play a role in the development of chronic gastritis and gastric cancer is still a question. So the investigators want to clarify this question by this subject.

Detailed description: This project was an untargeted metabolomics study using liquid chromatography coupled with mass spectrometry (LC-MS) in patients with chronic gastritis and gastric carcinoma. The experimental procedures mainly include sample collection, metabolite extraction, LC-MS/MS detection, data analysis, etc.The goal of this study is to identify and (relatively) quantify as many metabolites in biological systems as possible, so as to reveal the overall metabolite information to the maximum extent. Metabolomics aims to investigate the changes of metabolites in gastric tissues in patients with chronic gastritis and gastric carcinoma, and to study the biological processes in which these metabolites participate by screening the different metabolites in the different groups, and to reveal the mechanism of life activities in which they involved in.

Eligibility criteria: Inclusion Criteria:

* Patients with chronic superficial gastritis and chronic atrophic gastritis
* Patients with gastric carcinoma

Exclusion Criteria:

* Patients with history of surgery
* Patients with severe heart disease,lung disease or kidney disease.

Primary outcomes:
measure: Metabonomic difference in patients with chronic gastritis and gastric carcinoma
timeFrame: six months
Secondary outcomes:
measure: Association of different metabolic substances and disease results in chronic gastritis and gastric carcinoma
timeFrame: six months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine
state: Zhejiang University
Study officials:
affiliation: 2nd Affiliated Hospital, School of Medicine, Zhejiang university, China
name: Yuehua Han, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01198782: Evaluating Safety and Efficacy of FID 112903 Post Discontinuation of Long-term Use of RESTASIS® (Cyclosporine Ophthalmic Emulsion) 0.05%
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye Syndrome
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-09-10
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of FID 112903 given as an immediate treatment replacement in dry eye subjects that discontinue at least 6 months use of RESTASIS.


Eligibility criteria: Inclusion Criteria:

* Patients must be at least 18 years of age
* Patients must have a best corrected visual acuity of 0.6 LogMar or better in each eye, and must use Restasis BID for at least 6 months.
* Lastly, patients must have a sodium fluorescein (NaFl) corneal staining sum score of greater than or equal to 3 in the worse eye.

Exclusion Criteria:

* Patients cannot wear contact lenses during the study and cannot have a history of hypersensitivity to any component of FID 112903.
* Patients cannot have ocular or intraocular surgery or serious ocular trauma within the past 6 months, and cannot have punctal plugs of any type.
* Patients cannot use any prescription topical medication for other ocular conditions (such as glaucoma, uveitis, etc).
* Patients cannot use systemic medications that may contribute to dry eye if the dosing regimen has not been stable for at least 30 days prior to Visit 1.
* Patients cannot have ocular conditions that, in the opinion of the investigator, preclude the safe administration of the test article.
* Patients cannot have a history and/or current evidence of the following: epithelial herpes simplex keratitis (dendritic keratitis); vaccinia, active or recent varicella viral disease of the cornea and/or conjunctiva; active ocular rosacea; acute or chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal diseases of the eye.

Primary outcomes:
measure: The change from baseline in Total Corneal Staining.
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: http://iovs.arvojournals.org/article.aspx?articleid=2353102
Clinical trial NCT00002182: A Study of Megestrol Acetate in HIV-Infected Children
Official title: Megestrol Acetate For Failure To Thrive In Pediatric HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Placebos
Appetite Stimulants
Megestrol Acetate
Failure to Thrive
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 25
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if megestrol acetate is safe and effective in treating HIV-infected children with failure to thrive (FTT).

Detailed description: The study design is randomized, double-blind, placebo-controlled for 12 weeks with open-label drug offered after week 12.

Eligibility criteria: Inclusion Criteria

Patients must have:

* Documented HIV infection.
* Failure to thrive as defined by:
* crossing 2 percentile lines on standard weight for age curves over time or less than 5% percentile weight for age and falling from the curve or loss of 10% of baseline body weight.
* Resistant to oral nutritional supplementation (i.e., FTT despite a minimum 1-month trial of high-calorie oral supplements).
* Free of significant acute illness (mild upper respiratory tract infections allowed).
* Patients with chronic diarrhea allowed provided malabsorption and gastrointestinal infection ruled out.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms are excluded:

* Gastrointestinal infection or malabsorption.
* Significant acute illness.
* Any identified, untreated cause for failure to thrive other than underlying HIV infection.
* Medical contraindications to megestrol acetate.

Patients with any of the following prior conditions or symptoms are excluded:

Medical contraindications to megestrol acetate including a history of poorly-controlled hypertension, deep venous thrombosis, or heart failure.

History of prior megestrol acetate therapy in the past six months.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Juan
country: Puerto Rico
facility: Univ of Puerto Rico / Med Science Campus
Study officials:
References: