louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00854490: Follow-up Study of Small-intestinal Mucosal Injuries in Chronic Non-steroidal Anti-inflammatory Drugs (NSAIDs)-Users
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Enteropathy
Lead sponsor: Nagoya University
Sponsor class: OTHER
First posted: 2009-03-03
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic NSAID users

Brief summary: The purpose of this study is to evaluate the long-term clinical significance of small-intestinal mucosal injuries in chronic NSAIDs-users.


Eligibility criteria: Inclusion Criteria:

* written informed consent
* 20 to 85 years of age
* RA, OA, or low back pain
* taking oral diclofenac sodium over 3 months
* No change of drugs before 3 months
* under 5 mg of corticosteroid use
* CRP \< 1mg/dl

Exclusion Criteria:

* known or suspected small-bowel disease, including Crohn's disease and seronegative arthritis
* prostaglandins, metronidazole or salazosulfapyridine
* can not swallow
* with pacemaker
* after gastrointestinal operation
* serious concomitant cardiovascular, endocrine, gastrointestinal(including symptoms of ileus), neurologic, psychiatric, renal, or respiratory disease.
* any other conditions that the investigator feels would interfere with data interpretation or create under risk

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nagoya City
country: Japan
facility: Nagoya University Hospital
state: Aichi Prefecture
Study officials:
References:
Clinical trial NCT03674190: A Study Comparing the Outcome of Anterior Lumbar Fusion and Total Lumbar Disc Replacement
Official title: A Study Comparing the Outcome of Anterior Lumbar Fusion and Total Lumbar Disc Replacement
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Disc Disease Degenerative
Disk Degeneration
Disc Disease Lumbar
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Yara Asterfjord
First posted: 2018-09-17
Enrollment: 0
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: Total lumbar disc replacement has previously been compared to posterior fusion of the lumbar spine, showing some favor towards total disc replacement. The study aims to compare total disc replacement to anterior fusion, sparing the muscles of the back and thus comparing the two different methods using the same surgical approach.

Detailed description: A total of 170 patients are planned to be enrolled in the study. If the patients meet the inclusion criteria and accept to participate they will be randomized to either anterior lumbar fusion or total disc replacement. The method of choice will be blinded for the patients until the two year follow up is completed.

Follow-up: after one and two years. Questionnairs: ODI, VAS, EuroQol, and GA Flexion- Extension X-ray after one and two years Complications will be retrieved from the patient journals.

Eligibility criteria: Inclusion Criteria:

* Patients with disabling pain from degenerative disc disease(DDD) both clinical and radiological, in one or two segments of the lumbar spine from L4-S1, were prolonged conservative treatment has failed.
* The patient should be able to understand swedish written and spoken.
* The patient should be between the ages 18-65. The patient has to accept to participate in the study

Exclusion Criteria:

* More than two degenerated segments.
* Degeneration above the L4 segment.
* Did not agree to participate in the study
* Previous history of tumor, vertebral fracture, infection, lumbar fusion and dominating leg pain.
* Need for posterior decompression
* Pregnancy
* Psychiatric illness or drug abuse

Primary outcomes:
measure: ODI, Oswestry Disability Index
timeFrame: Two years
Secondary outcomes:
measure: VAS, Visual Analogue Scale
timeFrame: Two years
measure: Segment Mobility
timeFrame: Two years
measure: Patient reported back pain after two years in Swespine national registry
timeFrame: Two years
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Spine Center Göteborg
city: Göteborg
country: Sweden
facility: Spine Center Göteborg
Study officials:
affiliation: Karolinska Institutet
name: Svante Berg, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01197690: Association Between Fractional Exhaled Nitric Oxide and Asthma Control
Official title: Association Between Fractional Exhaled Nitric Oxide and Asthma Control
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchial Asthma
Keywords: Bronchial asthma
level of control of asthma
fractional exhaled nitric oxide (FeNO)
asthma control test (ACT)
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2010-09-09
Enrollment: 62
Sex: ALL
Minimum age (years): 7
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: atopic asthmatic patients in Department of Pediatrics, Siriraj hospital (tertiary care)

Brief summary: The purpose of this study is to determine mean or median of fractional exhaled nitric oxide (FeNO) in Thai atopic asthmatic patients that divided into subgroups due to level of asthma control according to the global initiative for asthma guideline.

Detailed description: From many previous studies, fractional exhaled nitric oxide (FeNO) has many benefits such as non-invasive, easily to perform, less time consume, has direct association with severity of inflammation of bronchial trees and sputum eosinophils, has benefit for diagnosis and monitoring the treatment in asthmatic patients.

In Thailand, this field of study is less extend, especially in children population. We hypothesized that in uncontrolled or partly controlled group may have high level of fractional exhaled nitric oxide (FeNO) than controlled group.

It is therefore desirable to examine the association between fractional exhaled nitric oxide (FeNO) and level of asthma control among atopic asthmatic Thai children and will be the main objective of this research.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of atopic bronchial asthma
* follow up in clinic of allergy and clinical immunology, Siriraj hospital

Exclusion Criteria:

* smoker or past history of smoking
* has chronic disease eg. HIV infection, pulmonary hypertension, systemic lupus erythematosus, liver cirrhosis, gastroesophageal reflux, COPD, bronchiectasis
* drink ethanol within 48 hours before enrollment
* history of upper or lower respiratory tract infection within 6 weeks before enrollment
* drink caffeine within day before enrollment
* during pregnancy
* history of systemic steroid use within 8 weeks before enrollment

Primary outcomes:
measure: fractional exhaled nitric oxide level
timeFrame: 10 minutes (average time), on the day of enrollment
Secondary outcomes:
measure: scores of asthma control test: ACT
timeFrame: 5 minutes (average time), on the day of enrollment
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj Hospital
Study officials:
affiliation: Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University
name: Professor Nualanong Visitsunthorn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05784090: Correlation Between Melatonin Levels in Different Biological Fluids
Official title: Livelli di Melatonina e Dei Suoi Precursori/Metaboliti in Differenti Fluidi Biologici: vi è Correlazione?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neurodegenerative Diseases
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2023-03-24
Enrollment: 36
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neurodegenerative disorders

Brief summary: The goal of this observational study is to evaluate and to correlate melatonin levels in plasma, saliva and cerebrospinal fluid (CSF) samples of patients undergoing lumbar puncture diagnostic for specific neurological diseases.


Eligibility criteria: Inclusion Criteria:

* Neurodegenerative disease

Exclusion Criteria:

* Age \< 18 years
* Pregnancy
* Coagulations disorders
* Anticoagulant therapy

Primary outcomes:
measure: Melatonin levels in saliva
timeFrame: Baseline
measure: Melatonin levels in plasma
timeFrame: Baseline
measure: Melatonin levels in cerebrospinal fluid
timeFrame: Baseline
Secondary outcomes:
measure: Orexin levels in cerebrospinal fluid
timeFrame: Baseline
measure: Neurofilaments light chain levels (NFL) in cerebrospinal fluid
timeFrame: Baseline
Other outcomes:
Locations:
city: Verbania
country: Italy
facility: Istituto Auxologico Italiano - S. Giuseppe Hospital
state: VB
Study officials:
References:
Clinical trial NCT04837690: UEMR for Medium-sized Pedunculated Colon Polyps
Official title: The Use of Underwater Endoscopic Mucosal Resection for Medium-sized Pedunculated Colon Polyps: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colon Polyp
Lead sponsor: Ningbo No. 1 Hospital
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients or inpatients requiring polypectomy

Brief summary: Underwater EMR (UEMR) is an emerging technique for endoscopic resection. The purpose of this research is to observ wether the UEMR for medium-sized pedunculated polyps is safe and effective.


Eligibility criteria: Inclusion Criteria:

Patients age between 18-75 years old with pedunculated colonic polyps (measuring between 10 and 20mm), who willing to participate in this study.

Exclusion Criteria:

1. pregnancy,
2. inflammatory bowel disease,
3. familial polyposis
4. the use of anticoagulant therapy or antiplatelet therapy
5. the absence of informed patient consent.
6. Polyps showing signs of deep submucosal invasion

Primary outcomes:
measure: The rate of bleeding
timeFrame: 1 Day of colonoscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Ningbo
country: China
facility: Ningbo First Hospital
state: Zhejiang
Study officials:
References:
Clinical trial NCT04662190: Evaluation of the Efficacy and Safety of 3D Printing for Orbital Surgery.
Official title: Eficàcia i Seguretat de la descompressió orbitària en Orbitopatia distiroïdal Utilitzant Models Individualitzats d'impressió 3D Per la planificació i simulació de la Cirurgia.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thyroid Associated Ophthalmopathy
Surgical Procedure, Unspecified
Lead sponsor: Althaia Xarxa Assistencial Universitària de Manresa
Sponsor class: OTHER
Collaborators: name: Societat Catalana d'Oftalmologia
First posted: 2020-12-10
Enrollment: 12
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: This is a multicentric, randomized, single-blinded clinical trial to evaluate the efficacy and safety of 3D printing for the planification and simulation of orbital decompression surgery for thyroid-associated orbitopathy.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of inactive thyroid-associated orbitopathy requiring bilateral orbital decompression (moderate-severe in EUGOGO classification).
* Volunteers older than 18 years old.
* Ability to read.
* Acceptation to participate and signature of informed consent.

Exclusion Criteria:

* Younger than 18 years old.
* Previous orbital surgery.
* Any coexisting disease preventing follow-up.

Primary outcomes:
measure: Intraoperative complications
timeFrame: 6 months
measure: Postoperative complications
timeFrame: 6 months
measure: Exophthalmos
timeFrame: 6 months
measure: Diplopia
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Manresa
country: Spain
facility: Eduard Pedemonte Sarrias
state: Barcelona
Study officials:
affiliation: Althaia Xarxa Assistencial Universitària de Manresa
name: Eduard Pedemonte-Sarrias, Md, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02023190: Changes in Body Composition and Nutritional Status in Patients Undergoing Liver Transplantation
Official title: Changes in Body Composition and Nutritional Status Assessed by Bioelectrical Impedance Vector Analysis in Cirrhotic Patients Undergoing Liver Transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Cirrhosis
Keywords: liver cirrhosis
liver transplant
nutritional status
bioelectrical impedance vector analysis
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
First posted: 2013-12-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be selected from the transplant enrollment list at the Department of Gastroenterology in a tertiary care center in Mexico

Brief summary: Liver transplant is the goal treatment for every patient with end-stage chronic liver disease.

Quality of life improves after transplant because the main complications of end-stage liver disease disappear, but due to immunosuppression other alterations appear such as metabolic alterations, weight gain, among others.

Body composition and nutritional status can be affected do to post-transplant pharmacologic therapy.

Detailed description: Body composition and nutritional status can be affected due to post-transplant pharmacologic therapy.

This is a prospective cohort study, patients from liver transplant waiting list will be assessed, pre and post-transplant measures of body composition and nutritional status will be obtained.

Eligibility criteria: Inclusion Criteria:

* Liver cirrhosis (any etiology)
* Enrolled in waiting list for tliver transplant

Exclusion Criteria:

* Hepatocellular carcinoma
* Chronic renal failure
* Congestive cardiac failure
* Extremity amputation
* Pregnancy

Primary outcomes:
measure: Body composition
timeFrame: Baseline, 7 days, 1 month, 3 months and 6 months post-tranpslant
Secondary outcomes:
measure: Liver function tests
timeFrame: Baseline, 7 days, 1 month, 3 months and 6 months post-tranpslant
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
state: DF
Study officials:
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Aldo Torre, MD MSci
role: STUDY_CHAIR
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Astrid Ruiz-Margáin, M.Sci
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00767390: CARTO 3 Human Patch Study
Official title: CARTO 3 ACL Patches Effectiveness Over Prolonged Clinical Case
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Healthy
Keywords: ACL Patch Placement
Lead sponsor: Biosense Webster, Inc.
Sponsor class: INDUSTRY
First posted: 2008-10-07
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Volunteers

Brief summary: The Purpose of this clinical investigation is to observe the changes in relative conductivity between the six ACL patches over time. In addition, the clinical investigation will evaluate the impact of prolonged placement of the ACL patches on subjects' skin on the chest and back. During the study the adhesiveness properties of the patches will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Signed Subject Informed Consent Form
* Healthy subject
* Age Range: 20 - 50 years
* BMI - half o the subjects 18-25 and half \>25
* Chest cage normal anatomy and dimensions
* No history of skin contact patch allergy, of any kind

Exclusion Criteria:

* Chest cage bony deformity
* Known skin allergies to patches, or dermatological conditions requiring therapy
* Presence of any active skin lesion on chest or back
* Any condition that preclude subject from lying down for six hours with minimal movement
* Pregnancy
* Subjects with devices, such as pace makers, IC, loop recorder

Primary outcomes:
measure: Absence of any clinically significant trauma to skin of the subjects at the ACL patches placement sites.
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Rambam Health Care Campus
name: Giris Jacob, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00160290: Trial to Evaluate Effect of Lactulose on Hard Stools in Patients With Hemorrhoids or Anal Fissures
Official title: An Open, Randomized, Parallel Group, Single Center Study to Investigate the Effect of Lactulose Versus Plantago Ovate on the Quality of Life of Patients With Hard Stools and Hemorrhoids or Anal Fissure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hemorrhoids
Anal Fissures
Keywords: lactulose
randomised clinical trial
hemorrhoids
anal fissures
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 97
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: To demonstrate that lactulose acts as a stool softener, relieving the pain at defecation, improving the number of defecations and regulating the colonic transit time in patients suffering of hemorrhoids or anal fissure. To compare efficacy and quality of life in patients treated either with lactulose or plantago ovate.


Eligibility criteria: Inclusion Criteria:

* Patients suffering from symptomatic hemorrhoids, or symptomatic anal fissure.

Exclusion Criteria:

* Patients suffering from malignant tumor in the intestine or the anal-rectal region, irritable colon, intestine inflammatory disease.

Primary outcomes:
measure: Quality of life of patients with hard stools and hemorrhoids or anal fissure
timeFrame: 6 weeks
Secondary outcomes:
measure: Gastrointestinal Symptoms Rating Scale
timeFrame: 6 weeks
measure: Bristol stool consistency scale
timeFrame: 6 weeks
measure: Number of episodes of rectal bleeding
timeFrame: 6 weeks
measure: Need of rescue medication
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Site 2
city: Granada
country: Spain
facility: Site 6
city: Huesca
country: Spain
facility: Site 5
city: Oviedo
country: Spain
facility: Site 7
city: Sabadell (Barcelona)
country: Spain
facility: Site 4
city: Sant Cugat del Vallès (Barcelona)
country: Spain
facility: Site 3
city: Santiago de Compostela
country: Spain
facility: Site 8
city: Valencia
country: Spain
facility: Site 1
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References:
Clinical trial NCT01005290: A Pharmacodynamic Study to Evaluate the Effect of a Fixed Dose Combination Pill on Blood Pressure
Official title: Cardiovascular Fixed Dose Combination Pill: A Pharmacodynamic Interaction Study to Evaluate the Effect of a Fixed Dose Combination of Acetylsalicylic Acid, Simvastatin and Ramipril (Cardiovascular Fixed Dose Combination Pill) on Blood Pressure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hypertension
Keywords: cardiovascular
fixed
dose
combination
pill
hypertension
Lead sponsor: Ferrer Internacional S.A.
Sponsor class: INDUSTRY
First posted: 2009-10-30
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to compare the effect on systolic pressure of the 3 drugs given together in the cardiovascular combination pill (acetylsalicylic acid, simvastatin, and ramipril) to the effect on systolic pressure of ramipril given alone.


Eligibility criteria: Inclusion Criteria:

* Subjects will be ≥18 years old
* Previously untreated systolic pressure result of ≥120\<160 mmHg and diastolic pressure result of ≥80\<100 mmHg

Exclusion Criteria:

* Subjects must not have previously received any anti-hypertensive medication
* must not have a systolic pressure \<120 mmHg or ≥160 mmHg and diastolic pressure result of \<80 mmHg or ≥100 mmHg
* must not have had a previous coronary artery bypass graft (CABG)
* must not have had a previous percutaneous transluminal coronary angioplasty (PTCA) with a drug-eluting stent
* must not have severe congestive heart failure (New York Heart Classification \[NYHC\] III-IV).

Primary outcomes:
measure: Difference in the Adjusted Mean 24-h Systolic Pressure Results (Using ABPM) Between the Basal and the Final Visit of Each Treatment Period.
timeFrame: Days 7 and 36 of Period 1 and days 49 and 85 of Period 2
Secondary outcomes:
measure: Difference in the Adjusted Mean 24-h Diastolic Pressure Results Between the Basal and the Final Visit of Each Treatment Period
timeFrame: Days 7 and 36 of Period 1 and days 49 and 85 of Period 2
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Valentin Fuster, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02587390: Effect of Gemcabene on the Pharmacokinetics of Simvastatin in Healthy Volunteers
Official title: A Study to Evaluate the Effects of Gemcabene on the Steady-State Pharmacokinetics and Pharmacodynamics of Simvastatin in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypercholesterolemia
Keywords: Pharmacokinetics
Lipid Regulator
Lead sponsor: NeuroBo Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2015-10-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine the effect of gemcabene on the pharmacokinetics of simvastatin 80 mg.


Eligibility criteria: Inclusion Criteria:

* Males and Females
* \>18 years of age
* Body weight 45 kg or greater

Exclusion Criteria:

* If female, of childbearing potential or lactation
* History of significant adverse reaction to any fibrate lipid-lowering agent or HMG-CoA reductase inhibitor

Primary outcomes:
measure: Pharmacokinetics
timeFrame: 15 days
measure: Pharmacokinetics
timeFrame: 15 days
Secondary outcomes:
measure: Adverse Events
timeFrame: 57 days
measure: Clinical Laboratory - hematology, chemistry, urinalysis
timeFrame: 57 days
measure: ECG
timeFrame: 57 days
Other outcomes:
Locations:
Study officials:
References: